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Progestogen-only pill shows promise as non-prescription contraception
Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women
Major finding: Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.
Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.
Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.
Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.
Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women
Major finding: Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.
Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.
Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.
Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.
Key clinical point: Daily use of 75 µg norgestrel was effective contraception for both breastfeeding and non-breastfeeding women
Major finding: Overall failure rates for non-breastfeeding women using 75 µg/day norgestrel ranged from 0-2.4/100 woman-years for an aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for norgestrel ranged from 0-3.4.
Study details: The data come from 13 studies of women who used a progestogen-only pill containing 75 µg/day norgestrel. The review included 6 studies with data on 3,144 women who were not breastfeeding and 7 studies with data on 5,258 women who were breastfeeding during part of the follow-up period. The women were followed for a total of 35,319 months.
Disclosures: The study received no outside funding. Lead author Dr. Anna Glasier and coauthor Stephanie Sober disclosed serving as independent consultants to HRA-Pharma.
Source: Glasier A et al. Contraception. 2021 Sep 6. doi: 10.1016/j.contraception.2021.08.016.
Contraception prescription patterns vary by specialty and geography
Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.
Major finding: Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.
Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring.
Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.
Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.
Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.
Major finding: Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.
Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring.
Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.
Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.
Key clinical point: The contraception workforce in the United States varies by geography, provider specialty, and Medicaid acceptance, and gaps remain in the provision of IUDs and implants.
Major finding: Approximately 73% of obgyns and nurse midwives prescribed the pill, patch, or ring, compared to 51% of family medicine physicians, 32% of pediatricians, and 20% of internal medicine physicians. A majority of obgyns provided contraception to Medicaid patients, ranging from 84% in the District of Columbia to 100% in North Dakota.
Study details: The data come from an observational study of the contraception workforce in the United States. A team of researchers created a comprehensive database of the workforce in the United States that provides six contraception types: intrauterine device (IUD), implant, shot (depot medroxyprogesterone acetate, or DMPA), oral contraception, hormonal patch, and vaginal ring.
Disclosures: The study was funded by a private foundation that wishes to remain anonymous. The researchers had no financial conflicts to disclose.
Source: Chen C et al. Am J Obstet Gynecol. 2021 Aug 18. doi: 10.1016/j.ajog.2021.08.015.
FDA panel backs Pfizer's COVID booster for 65 and older, those at high risk
An expert panel that advises the Food and Drug Administration on its regulatory decisions voted Sept. 17 against recommending third doses of Pfizer’s COVID-19 vaccine for younger Americans.
But they didn’t kill the idea of booster shots completely.
In a dramatic, last-minute pivot, the 18 members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend the FDA make boosters available for seniors and others at high risk of severe outcomes from COVID-19, including health care workers.
The 16-2 vote was a rebuttal to Pfizer’s initial request. The company had asked the FDA to allow it to offer third doses to all Americans over the age of 16 at least six months after their second shot.
The company requested an amendment to the full approval the FDA granted in August. That is the typical way boosters are authorized in the U.S., but it requires a higher bar of evidence and more regulatory scrutiny than the agency had been able to give since Pfizer filed for the change just days after its vaccine was granted full approval.
The committee’s actions were also a rebuff to the Biden administration, which announced before the FDA approved them that boosters would be rolled out to the general public Sept. 20. The announcement triggered the resignations of two of the agency’s top vaccine reviewers, who both participated in the Sept. 17 meeting.
After initially voting against Pfizer’s request to amend its license, the committee then worked on the fly with FDA officials to craft a strategy that would allow third doses to be offered under an emergency use authorization (EUA).
An EUA requires a lower standard of evidence and is more specific. It will restrict third doses to a more defined population than a change to the license would. It will also require Pfizer to continue to monitor the safety of third doses as they begin to be administered.
“This should demonstrate to the public that the members of this committee are independent of the FDA and that we do, in fact, bring our voices to the table when we are asked to serve on this committee,” said Archana Chattergee, MD, a pediatric infectious disease specialist who is dean of the Chicago Medical School at Rosalind Franklin University in Illinois.
The FDA doesn’t have to follow the committee’s recommendation, but almost certainly will, though regulators said they may still make some changes.
“We are not bound at FDA by your vote, we can tweak this,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA. Dr. Marks participated in the meeting and helped to draft the revised proposal.
If the FDA issues the recommended EUA, a council of independent advisors to the CDC will make specific recommendations about how the third doses should be given. After the CDC director weighs in, boosters will begin rolling out to the public.
Moderna submitted data to the FDA on Sept. 1 in support of adding a booster dose to its regimen. The agency has not yet scheduled a public review of that data.
The Biden administration is prepared to administer shots as soon as they get the green light, Surgeon General Vivek Murthy, MD, said at a White House briefing earlier Sept. 17.
"This process is consistent with what we outlined in August where our goals were to stay ahead of the virus," Dr. Murthy said. "Our goal then and now is to protect the health and well-being of the public. As soon as the FDA and CDC complete their evaluations, we will be ready to move forward accordingly."
He added, "We've used this time since our August announcement to communicate and coordinate with pharmacy partners, nursing homes, states, and localities."
White House COVID-19 Response Coordinator Jeff Zients said vaccine supply is "in good shape for all Americans to get boosters as recommended."
Taking cues from Israel
In considering Pfizer’s original request, the committee overwhelmingly felt that they didn’t have enough information to say that the benefits of an additional dose of vaccine in 16- and 17-year-olds would outweigh its risk. Teens have the highest risk of rare heart inflammation after vaccination, a side effect known as myocarditis. It is not known how the vaccines are causing these cases of heart swelling. Most who have been diagnosed with the condition have recovered, though some have needed hospital care.
Pfizer didn’t include 16- and 17-year-olds in its studies of boosters, which included about 300 people between the ages of 18 and 55. The company acknowledged that gap in its data but pointed to FDA guidance that said evidence from adults could be extrapolated to teens.
“We don’t know that much about risks,” said committee member Eric Rubin, MD, who is editor-in-chief of the New England Journal of Medicine.
Much of the data on the potential benefits and harms of third Pfizer doses comes from Israel, which first began rolling out boosters to older adults in July.
In a highly anticipated presentation, Sharon Alroy-Preis, Israel’s director of public health services, joined the meeting to describe Israel’s experience with boosters.
Israel began to see a third surge of COVID-19 cases in December.
“This was after having two waves and two lockdowns,” Ms. Alroy-Preis said. By the third surge, she said, Israelis were tired.
“We decided on a lockdown, but the compliance of the public wasn’t as it was in the previous two waves,” she said.
Then the vaccine arrived. Israel started vaccinations as soon as the FDA approved it, and they quickly vaccinated a high percentage of their population, about 3 months faster than the rest of the world.
All vaccinations are reported and tracked by the Ministry of Health, so the country is able to keep close tabs on how well the shots are working.
As vaccines rolled out, cases fell dramatically. The pandemic seemed to be behind them. Delta arrived in March. By June, their cases were doubling every 10 days, despite about 80% of their most vulnerable adults being fully vaccinated, she said.
Most concerning was that about 60% of severe cases were breakthrough cases in fully vaccinated individuals.
“We had to stop and figure out, was this a Delta issue,” she said. “Or was this a waning immunity issue.”
“We had some clue that it might not be the Delta variant, at least not alone,” she said.
People who had originally been first in line for the vaccines, seniors and health care workers, were having the highest rates of breakthrough infections. People further away from their second dose were more likely to get a breakthrough infection.
Ms. Alroy-Preis said that if they had not started booster doses in July, their hospitals would have been overwhelmed. They had projected that they would have 2,000 cases in the hospital each day.
Boosters have helped to flatten the curve, though they are still seeing a significant number of infections.
Data from Israel presented at the meeting show boosters are largely safe and effective at reducing severe outcomes in seniors. Israeli experience also showed that third doses, which generate very high levels of neutralizing antibodies—the first and fastest line of the body’s immune defense - -may also slow transmission of the virus.
Key differences in the U.S.
The benefit of slowing down the explosive spread of a highly contagious virus was tantalizing, but many members noted that circumstances in Israel are very different than in the United States. Israel went into its current Delta surge already having high levels of vaccination in its population. They also relied on the Pfizer vaccine almost exclusively for their campaign.
The United States used a different mix of vaccines – Pfizer, Moderna, and Johnson & Johnson -- and doesn’t have the same high level of vaccination coverage of its population.
In the United States, transmission is mainly being driven by unvaccinated people, Dr. Rubin noted.
“That really means the primary benefit is going to be in reducing disease,” he said, “And we know the people who are going to benefit from that … and those are the kinds of people the FDA has already approved a third dose for,” he said, referring to those with underlying health conditions.
But Israel only began vaccinating younger people a few weeks ago. Most are still within a window where rare risks like myocarditis could appear, Rubin noted.
He and other members of the committee said they wished they had more information about the safety of third doses in younger adults.
“We don’t have that right now, and I don’t think I would be comfortable giving it to a 16-year-old,” he said.
At the same time, the primary benefit for third doses would be in preventing severe disease, and overall, data from the United States and other countries show that two doses of the vaccines remain highly effective at preventing hospitalization and death.
Asked why Israel began to see more severe cases in fully vaccinated people, the CDC’s Sara Oliver, MD, a disease detective with the CDC, said it was probably due to a mix of factors including the fact that Israel defines severe cases a little differently.
In the United States, a severe case is generally a person who has to be hospitalized or who has died from the infection. In Israel, a person with a severe case is someone who has an elevated respiratory rate and someone who has a blood oxygen level less than 94%. In the United States, that kind of patient wouldn’t necessarily be hospitalized.
In the end, one of the two committee members who wanted full approval for Pfizer’s third doses said he was satisfied with the outcome.
Mark Sawyer, MD, a professor of pediatrics and infectious disease at the University of California at San Diego, said he voted yes on the first question because he thought full approval was the best way to give doctors the flexibility to prescribe the shots to vulnerable individuals.
“I’m really glad we authorized a vaccine for a third dose, and I plan to go out and get my vaccine this afternoon,” Dr. Sawyer said, noting that he was at high risk as a health care provider.
This article was updated 9/19/21.
A version of this article first appeared on Medscape.com.
An expert panel that advises the Food and Drug Administration on its regulatory decisions voted Sept. 17 against recommending third doses of Pfizer’s COVID-19 vaccine for younger Americans.
But they didn’t kill the idea of booster shots completely.
In a dramatic, last-minute pivot, the 18 members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend the FDA make boosters available for seniors and others at high risk of severe outcomes from COVID-19, including health care workers.
The 16-2 vote was a rebuttal to Pfizer’s initial request. The company had asked the FDA to allow it to offer third doses to all Americans over the age of 16 at least six months after their second shot.
The company requested an amendment to the full approval the FDA granted in August. That is the typical way boosters are authorized in the U.S., but it requires a higher bar of evidence and more regulatory scrutiny than the agency had been able to give since Pfizer filed for the change just days after its vaccine was granted full approval.
The committee’s actions were also a rebuff to the Biden administration, which announced before the FDA approved them that boosters would be rolled out to the general public Sept. 20. The announcement triggered the resignations of two of the agency’s top vaccine reviewers, who both participated in the Sept. 17 meeting.
After initially voting against Pfizer’s request to amend its license, the committee then worked on the fly with FDA officials to craft a strategy that would allow third doses to be offered under an emergency use authorization (EUA).
An EUA requires a lower standard of evidence and is more specific. It will restrict third doses to a more defined population than a change to the license would. It will also require Pfizer to continue to monitor the safety of third doses as they begin to be administered.
“This should demonstrate to the public that the members of this committee are independent of the FDA and that we do, in fact, bring our voices to the table when we are asked to serve on this committee,” said Archana Chattergee, MD, a pediatric infectious disease specialist who is dean of the Chicago Medical School at Rosalind Franklin University in Illinois.
The FDA doesn’t have to follow the committee’s recommendation, but almost certainly will, though regulators said they may still make some changes.
“We are not bound at FDA by your vote, we can tweak this,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA. Dr. Marks participated in the meeting and helped to draft the revised proposal.
If the FDA issues the recommended EUA, a council of independent advisors to the CDC will make specific recommendations about how the third doses should be given. After the CDC director weighs in, boosters will begin rolling out to the public.
Moderna submitted data to the FDA on Sept. 1 in support of adding a booster dose to its regimen. The agency has not yet scheduled a public review of that data.
The Biden administration is prepared to administer shots as soon as they get the green light, Surgeon General Vivek Murthy, MD, said at a White House briefing earlier Sept. 17.
"This process is consistent with what we outlined in August where our goals were to stay ahead of the virus," Dr. Murthy said. "Our goal then and now is to protect the health and well-being of the public. As soon as the FDA and CDC complete their evaluations, we will be ready to move forward accordingly."
He added, "We've used this time since our August announcement to communicate and coordinate with pharmacy partners, nursing homes, states, and localities."
White House COVID-19 Response Coordinator Jeff Zients said vaccine supply is "in good shape for all Americans to get boosters as recommended."
Taking cues from Israel
In considering Pfizer’s original request, the committee overwhelmingly felt that they didn’t have enough information to say that the benefits of an additional dose of vaccine in 16- and 17-year-olds would outweigh its risk. Teens have the highest risk of rare heart inflammation after vaccination, a side effect known as myocarditis. It is not known how the vaccines are causing these cases of heart swelling. Most who have been diagnosed with the condition have recovered, though some have needed hospital care.
Pfizer didn’t include 16- and 17-year-olds in its studies of boosters, which included about 300 people between the ages of 18 and 55. The company acknowledged that gap in its data but pointed to FDA guidance that said evidence from adults could be extrapolated to teens.
“We don’t know that much about risks,” said committee member Eric Rubin, MD, who is editor-in-chief of the New England Journal of Medicine.
Much of the data on the potential benefits and harms of third Pfizer doses comes from Israel, which first began rolling out boosters to older adults in July.
In a highly anticipated presentation, Sharon Alroy-Preis, Israel’s director of public health services, joined the meeting to describe Israel’s experience with boosters.
Israel began to see a third surge of COVID-19 cases in December.
“This was after having two waves and two lockdowns,” Ms. Alroy-Preis said. By the third surge, she said, Israelis were tired.
“We decided on a lockdown, but the compliance of the public wasn’t as it was in the previous two waves,” she said.
Then the vaccine arrived. Israel started vaccinations as soon as the FDA approved it, and they quickly vaccinated a high percentage of their population, about 3 months faster than the rest of the world.
All vaccinations are reported and tracked by the Ministry of Health, so the country is able to keep close tabs on how well the shots are working.
As vaccines rolled out, cases fell dramatically. The pandemic seemed to be behind them. Delta arrived in March. By June, their cases were doubling every 10 days, despite about 80% of their most vulnerable adults being fully vaccinated, she said.
Most concerning was that about 60% of severe cases were breakthrough cases in fully vaccinated individuals.
“We had to stop and figure out, was this a Delta issue,” she said. “Or was this a waning immunity issue.”
“We had some clue that it might not be the Delta variant, at least not alone,” she said.
People who had originally been first in line for the vaccines, seniors and health care workers, were having the highest rates of breakthrough infections. People further away from their second dose were more likely to get a breakthrough infection.
Ms. Alroy-Preis said that if they had not started booster doses in July, their hospitals would have been overwhelmed. They had projected that they would have 2,000 cases in the hospital each day.
Boosters have helped to flatten the curve, though they are still seeing a significant number of infections.
Data from Israel presented at the meeting show boosters are largely safe and effective at reducing severe outcomes in seniors. Israeli experience also showed that third doses, which generate very high levels of neutralizing antibodies—the first and fastest line of the body’s immune defense - -may also slow transmission of the virus.
Key differences in the U.S.
The benefit of slowing down the explosive spread of a highly contagious virus was tantalizing, but many members noted that circumstances in Israel are very different than in the United States. Israel went into its current Delta surge already having high levels of vaccination in its population. They also relied on the Pfizer vaccine almost exclusively for their campaign.
The United States used a different mix of vaccines – Pfizer, Moderna, and Johnson & Johnson -- and doesn’t have the same high level of vaccination coverage of its population.
In the United States, transmission is mainly being driven by unvaccinated people, Dr. Rubin noted.
“That really means the primary benefit is going to be in reducing disease,” he said, “And we know the people who are going to benefit from that … and those are the kinds of people the FDA has already approved a third dose for,” he said, referring to those with underlying health conditions.
But Israel only began vaccinating younger people a few weeks ago. Most are still within a window where rare risks like myocarditis could appear, Rubin noted.
He and other members of the committee said they wished they had more information about the safety of third doses in younger adults.
“We don’t have that right now, and I don’t think I would be comfortable giving it to a 16-year-old,” he said.
At the same time, the primary benefit for third doses would be in preventing severe disease, and overall, data from the United States and other countries show that two doses of the vaccines remain highly effective at preventing hospitalization and death.
Asked why Israel began to see more severe cases in fully vaccinated people, the CDC’s Sara Oliver, MD, a disease detective with the CDC, said it was probably due to a mix of factors including the fact that Israel defines severe cases a little differently.
In the United States, a severe case is generally a person who has to be hospitalized or who has died from the infection. In Israel, a person with a severe case is someone who has an elevated respiratory rate and someone who has a blood oxygen level less than 94%. In the United States, that kind of patient wouldn’t necessarily be hospitalized.
In the end, one of the two committee members who wanted full approval for Pfizer’s third doses said he was satisfied with the outcome.
Mark Sawyer, MD, a professor of pediatrics and infectious disease at the University of California at San Diego, said he voted yes on the first question because he thought full approval was the best way to give doctors the flexibility to prescribe the shots to vulnerable individuals.
“I’m really glad we authorized a vaccine for a third dose, and I plan to go out and get my vaccine this afternoon,” Dr. Sawyer said, noting that he was at high risk as a health care provider.
This article was updated 9/19/21.
A version of this article first appeared on Medscape.com.
An expert panel that advises the Food and Drug Administration on its regulatory decisions voted Sept. 17 against recommending third doses of Pfizer’s COVID-19 vaccine for younger Americans.
But they didn’t kill the idea of booster shots completely.
In a dramatic, last-minute pivot, the 18 members of the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend the FDA make boosters available for seniors and others at high risk of severe outcomes from COVID-19, including health care workers.
The 16-2 vote was a rebuttal to Pfizer’s initial request. The company had asked the FDA to allow it to offer third doses to all Americans over the age of 16 at least six months after their second shot.
The company requested an amendment to the full approval the FDA granted in August. That is the typical way boosters are authorized in the U.S., but it requires a higher bar of evidence and more regulatory scrutiny than the agency had been able to give since Pfizer filed for the change just days after its vaccine was granted full approval.
The committee’s actions were also a rebuff to the Biden administration, which announced before the FDA approved them that boosters would be rolled out to the general public Sept. 20. The announcement triggered the resignations of two of the agency’s top vaccine reviewers, who both participated in the Sept. 17 meeting.
After initially voting against Pfizer’s request to amend its license, the committee then worked on the fly with FDA officials to craft a strategy that would allow third doses to be offered under an emergency use authorization (EUA).
An EUA requires a lower standard of evidence and is more specific. It will restrict third doses to a more defined population than a change to the license would. It will also require Pfizer to continue to monitor the safety of third doses as they begin to be administered.
“This should demonstrate to the public that the members of this committee are independent of the FDA and that we do, in fact, bring our voices to the table when we are asked to serve on this committee,” said Archana Chattergee, MD, a pediatric infectious disease specialist who is dean of the Chicago Medical School at Rosalind Franklin University in Illinois.
The FDA doesn’t have to follow the committee’s recommendation, but almost certainly will, though regulators said they may still make some changes.
“We are not bound at FDA by your vote, we can tweak this,” said Peter Marks, MD, director of the Center for Biologics Evaluation and Research at the FDA. Dr. Marks participated in the meeting and helped to draft the revised proposal.
If the FDA issues the recommended EUA, a council of independent advisors to the CDC will make specific recommendations about how the third doses should be given. After the CDC director weighs in, boosters will begin rolling out to the public.
Moderna submitted data to the FDA on Sept. 1 in support of adding a booster dose to its regimen. The agency has not yet scheduled a public review of that data.
The Biden administration is prepared to administer shots as soon as they get the green light, Surgeon General Vivek Murthy, MD, said at a White House briefing earlier Sept. 17.
"This process is consistent with what we outlined in August where our goals were to stay ahead of the virus," Dr. Murthy said. "Our goal then and now is to protect the health and well-being of the public. As soon as the FDA and CDC complete their evaluations, we will be ready to move forward accordingly."
He added, "We've used this time since our August announcement to communicate and coordinate with pharmacy partners, nursing homes, states, and localities."
White House COVID-19 Response Coordinator Jeff Zients said vaccine supply is "in good shape for all Americans to get boosters as recommended."
Taking cues from Israel
In considering Pfizer’s original request, the committee overwhelmingly felt that they didn’t have enough information to say that the benefits of an additional dose of vaccine in 16- and 17-year-olds would outweigh its risk. Teens have the highest risk of rare heart inflammation after vaccination, a side effect known as myocarditis. It is not known how the vaccines are causing these cases of heart swelling. Most who have been diagnosed with the condition have recovered, though some have needed hospital care.
Pfizer didn’t include 16- and 17-year-olds in its studies of boosters, which included about 300 people between the ages of 18 and 55. The company acknowledged that gap in its data but pointed to FDA guidance that said evidence from adults could be extrapolated to teens.
“We don’t know that much about risks,” said committee member Eric Rubin, MD, who is editor-in-chief of the New England Journal of Medicine.
Much of the data on the potential benefits and harms of third Pfizer doses comes from Israel, which first began rolling out boosters to older adults in July.
In a highly anticipated presentation, Sharon Alroy-Preis, Israel’s director of public health services, joined the meeting to describe Israel’s experience with boosters.
Israel began to see a third surge of COVID-19 cases in December.
“This was after having two waves and two lockdowns,” Ms. Alroy-Preis said. By the third surge, she said, Israelis were tired.
“We decided on a lockdown, but the compliance of the public wasn’t as it was in the previous two waves,” she said.
Then the vaccine arrived. Israel started vaccinations as soon as the FDA approved it, and they quickly vaccinated a high percentage of their population, about 3 months faster than the rest of the world.
All vaccinations are reported and tracked by the Ministry of Health, so the country is able to keep close tabs on how well the shots are working.
As vaccines rolled out, cases fell dramatically. The pandemic seemed to be behind them. Delta arrived in March. By June, their cases were doubling every 10 days, despite about 80% of their most vulnerable adults being fully vaccinated, she said.
Most concerning was that about 60% of severe cases were breakthrough cases in fully vaccinated individuals.
“We had to stop and figure out, was this a Delta issue,” she said. “Or was this a waning immunity issue.”
“We had some clue that it might not be the Delta variant, at least not alone,” she said.
People who had originally been first in line for the vaccines, seniors and health care workers, were having the highest rates of breakthrough infections. People further away from their second dose were more likely to get a breakthrough infection.
Ms. Alroy-Preis said that if they had not started booster doses in July, their hospitals would have been overwhelmed. They had projected that they would have 2,000 cases in the hospital each day.
Boosters have helped to flatten the curve, though they are still seeing a significant number of infections.
Data from Israel presented at the meeting show boosters are largely safe and effective at reducing severe outcomes in seniors. Israeli experience also showed that third doses, which generate very high levels of neutralizing antibodies—the first and fastest line of the body’s immune defense - -may also slow transmission of the virus.
Key differences in the U.S.
The benefit of slowing down the explosive spread of a highly contagious virus was tantalizing, but many members noted that circumstances in Israel are very different than in the United States. Israel went into its current Delta surge already having high levels of vaccination in its population. They also relied on the Pfizer vaccine almost exclusively for their campaign.
The United States used a different mix of vaccines – Pfizer, Moderna, and Johnson & Johnson -- and doesn’t have the same high level of vaccination coverage of its population.
In the United States, transmission is mainly being driven by unvaccinated people, Dr. Rubin noted.
“That really means the primary benefit is going to be in reducing disease,” he said, “And we know the people who are going to benefit from that … and those are the kinds of people the FDA has already approved a third dose for,” he said, referring to those with underlying health conditions.
But Israel only began vaccinating younger people a few weeks ago. Most are still within a window where rare risks like myocarditis could appear, Rubin noted.
He and other members of the committee said they wished they had more information about the safety of third doses in younger adults.
“We don’t have that right now, and I don’t think I would be comfortable giving it to a 16-year-old,” he said.
At the same time, the primary benefit for third doses would be in preventing severe disease, and overall, data from the United States and other countries show that two doses of the vaccines remain highly effective at preventing hospitalization and death.
Asked why Israel began to see more severe cases in fully vaccinated people, the CDC’s Sara Oliver, MD, a disease detective with the CDC, said it was probably due to a mix of factors including the fact that Israel defines severe cases a little differently.
In the United States, a severe case is generally a person who has to be hospitalized or who has died from the infection. In Israel, a person with a severe case is someone who has an elevated respiratory rate and someone who has a blood oxygen level less than 94%. In the United States, that kind of patient wouldn’t necessarily be hospitalized.
In the end, one of the two committee members who wanted full approval for Pfizer’s third doses said he was satisfied with the outcome.
Mark Sawyer, MD, a professor of pediatrics and infectious disease at the University of California at San Diego, said he voted yes on the first question because he thought full approval was the best way to give doctors the flexibility to prescribe the shots to vulnerable individuals.
“I’m really glad we authorized a vaccine for a third dose, and I plan to go out and get my vaccine this afternoon,” Dr. Sawyer said, noting that he was at high risk as a health care provider.
This article was updated 9/19/21.
A version of this article first appeared on Medscape.com.
‘Urgent’ need to understand immunotherapy de-escalation in NSCLC
However, the research to date does not provide a clear picture of which patients will achieve this “exceptional and durable response” and at which point patients can safely reduce or withdraw from treatment, according to Yasushi Goto, MD, PhD, a staff doctor in the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
Dr. Goto presented the latest evidence and explored the current unknowns surrounding immunotherapy de-escalation in NSCLC in a session this week at the virtual World Conference on Lung Cancer.
In addition to a toxicity and quality-of-life benefit for patients, immunotherapy de-escalation could have a significant impact on the costs of care, Dr. Goto stressed. The rising cost of new cancer treatments represents a “crisis” in terms of the affordability of health care, he said, and reducing these costs represents an “urgent global issue.”
Evidence on discontinuing treatment
Dr. Goto kicked off the session by emphasizing how drastically immunotherapy has enhanced outcomes for patients with NSCLC and other cancers.
This success has brought a pressing clinical question to the forefront: How long should we treat patients with immunotherapy?
The question arose over 10 years ago when ipilimumab (Yervoy) was granted FDA approval for patients with metastatic melanoma, but only for a total of four doses because of the drug’s toxicity.
“However, some patients had very lasting efficacy with the drug, even after discontinuation,” Dr. Goto said, which raised the exciting prospect that patients could achieve a functional cure with immunotherapy.
Evidence highlighting this lasting effect among patients with NSCLC soon emerged as well. A 2015 study, for instance, indicated that, despite toxicities, 50% of patients receiving nivolumab (Opdivo) continued to have a treatment effect more than 9 months after their last dose.
A 2021 analysis of patients receiving pembrolizumab (Keytruda) found that 48% of patients were disease-free after 5 years, despite having discontinued treatment after 2 years.
These investigators also found that toxicities accumulated over time – new grade greater than or equal to three toxicities occurred in 10% of patients every 6 months – which makes it particularly important to consider limiting the duration of therapy, Dr. Goto noted.
Only one randomized study to date – the CheckMate 153 trial – has explicitly explored outcomes associated with discontinuing immunotherapy in patients with NSCLC. In this study, patients still receiving nivolumab after 1 year were randomized to continue or stop therapy. Both median progression-free survival and overall survival were significantly longer in patients who continued therapy versus those who stopped at 1 year.
However, Dr. Goto noted that limitations in the study design, including the fact that many patients were censored at an early stage, made the results “nonconfirmatory” and he would like to see more data.
The role of re-treatment
Finding the optimal time to discontinue treatment is critical but even if patients stop treatment before they achieve long-lasting benefits, they can still be retreated successfully.
Two recent studies examined the potential benefits of re-treatment. In the 2021 KEYNOTE-010 analysis, 21 patients received a second course of pembrolizumab, at a response rate of 53% and a disease control rate of 81%.
In another recent study, investigators found that among 78 patients with melanoma who had discontinued either nivolumab or pembrolizumab and were re-treated after disease progression, 15% (5 of 34) receiving a single anti-PD-1 agent responded to retreatment and 25% (11 of 44) escalated to nivolumab plus ipilimumab exhibited a response.
Dr. Goto noted that there are also ongoing randomized studies examining the optimal duration of immunotherapy in advanced melanoma. One that he is involved in, the SAVE study, is enrolling patients with advanced NSCLC who have responded to anti-PD-1 agents for over a year and will compare overall survival in those who stop therapy versus those who continue. In addition, given the “growing importance” of biomarkers as a prediction tool, Dr. Goto plans to integrate circulating tumor DNA testing to help identify patients more likely to benefit from therapy discontinuation.
If successful, such approaches could “disruptively decrease prescribing costs,” by lowering doses or dose frequency, shortening the treatment duration, or by substituting therapies with fewer adverse effects, Dr. Goto said.
Discussing de-escalation in practice
During the discussion period after his talk, session co-chair Loretta Erhunmwunsee, MD, City of Hope Comprehensive Cancer Center, Duarte, California, asked Dr. Goto what his current practice is in regard to de-escalation.
He replied that, in Japan, physicians are allowed to continue immunotherapy beyond 2 years, but “many patients stop their immune checkpoint inhibitor due to toxicity,” even if it is minor.
Exploring evidence surrounding the optimal duration of therapy, session cochair Bishal Gyawali, MD, PhD, Queen’s University, Kingston, Canada, pointed to collaborative studies in colon cancer that looked at chemotherapy duration, for example looking at 3 versus 6 months of treatment.
Dr. Gyawali wondered whether the same could be achieved in lung cancer to test the non-inferiority of shorter duration of immunotherapy versus continuing treatment until disease progression.
Dr. Goto noted that the biggest difference in the current context of NSCLC is the toxicity incurred by both the adjuvant chemotherapy and the immunotherapy, making the overall benefit to the patient “very difficult to show.” Consequently, patients may not be willing to join a randomized trial in which they could experience additional toxicity for uncertain benefit.
City of Hope oncologist H. Jack West, MD, who presented at the session, said he would “love to see more trials looking at de-escalation and seeing whether we do just as well on efficacy with lower toxicity and lower costs.”
Instead, “we are seeing reports of the fourth entrant into the field that just recapitulates things we already know,” which is “terribly disappointing.”
“I really wish we could vote with our feet more and not participate in trials that are completely redundant compared to what we’ve had for years already,” Dr. West said.
No funding for this study was declared. Dr. Goto disclosed relationships with AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Guardant Health, Illumina, Kyorin, MSD, Novartis, Ono Pharmaceutical, Pfizer, Shionogi Pharma, and Taiho Pharmaceutical. Dr. West disclosed relationships with AstraZeneca, EQRx, Genentech/Roche, Merck, Mirati, and Regeneron and is a regular contributor to Medscape Oncology.
A version of this article first appeared on Medscape.com.
However, the research to date does not provide a clear picture of which patients will achieve this “exceptional and durable response” and at which point patients can safely reduce or withdraw from treatment, according to Yasushi Goto, MD, PhD, a staff doctor in the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
Dr. Goto presented the latest evidence and explored the current unknowns surrounding immunotherapy de-escalation in NSCLC in a session this week at the virtual World Conference on Lung Cancer.
In addition to a toxicity and quality-of-life benefit for patients, immunotherapy de-escalation could have a significant impact on the costs of care, Dr. Goto stressed. The rising cost of new cancer treatments represents a “crisis” in terms of the affordability of health care, he said, and reducing these costs represents an “urgent global issue.”
Evidence on discontinuing treatment
Dr. Goto kicked off the session by emphasizing how drastically immunotherapy has enhanced outcomes for patients with NSCLC and other cancers.
This success has brought a pressing clinical question to the forefront: How long should we treat patients with immunotherapy?
The question arose over 10 years ago when ipilimumab (Yervoy) was granted FDA approval for patients with metastatic melanoma, but only for a total of four doses because of the drug’s toxicity.
“However, some patients had very lasting efficacy with the drug, even after discontinuation,” Dr. Goto said, which raised the exciting prospect that patients could achieve a functional cure with immunotherapy.
Evidence highlighting this lasting effect among patients with NSCLC soon emerged as well. A 2015 study, for instance, indicated that, despite toxicities, 50% of patients receiving nivolumab (Opdivo) continued to have a treatment effect more than 9 months after their last dose.
A 2021 analysis of patients receiving pembrolizumab (Keytruda) found that 48% of patients were disease-free after 5 years, despite having discontinued treatment after 2 years.
These investigators also found that toxicities accumulated over time – new grade greater than or equal to three toxicities occurred in 10% of patients every 6 months – which makes it particularly important to consider limiting the duration of therapy, Dr. Goto noted.
Only one randomized study to date – the CheckMate 153 trial – has explicitly explored outcomes associated with discontinuing immunotherapy in patients with NSCLC. In this study, patients still receiving nivolumab after 1 year were randomized to continue or stop therapy. Both median progression-free survival and overall survival were significantly longer in patients who continued therapy versus those who stopped at 1 year.
However, Dr. Goto noted that limitations in the study design, including the fact that many patients were censored at an early stage, made the results “nonconfirmatory” and he would like to see more data.
The role of re-treatment
Finding the optimal time to discontinue treatment is critical but even if patients stop treatment before they achieve long-lasting benefits, they can still be retreated successfully.
Two recent studies examined the potential benefits of re-treatment. In the 2021 KEYNOTE-010 analysis, 21 patients received a second course of pembrolizumab, at a response rate of 53% and a disease control rate of 81%.
In another recent study, investigators found that among 78 patients with melanoma who had discontinued either nivolumab or pembrolizumab and were re-treated after disease progression, 15% (5 of 34) receiving a single anti-PD-1 agent responded to retreatment and 25% (11 of 44) escalated to nivolumab plus ipilimumab exhibited a response.
Dr. Goto noted that there are also ongoing randomized studies examining the optimal duration of immunotherapy in advanced melanoma. One that he is involved in, the SAVE study, is enrolling patients with advanced NSCLC who have responded to anti-PD-1 agents for over a year and will compare overall survival in those who stop therapy versus those who continue. In addition, given the “growing importance” of biomarkers as a prediction tool, Dr. Goto plans to integrate circulating tumor DNA testing to help identify patients more likely to benefit from therapy discontinuation.
If successful, such approaches could “disruptively decrease prescribing costs,” by lowering doses or dose frequency, shortening the treatment duration, or by substituting therapies with fewer adverse effects, Dr. Goto said.
Discussing de-escalation in practice
During the discussion period after his talk, session co-chair Loretta Erhunmwunsee, MD, City of Hope Comprehensive Cancer Center, Duarte, California, asked Dr. Goto what his current practice is in regard to de-escalation.
He replied that, in Japan, physicians are allowed to continue immunotherapy beyond 2 years, but “many patients stop their immune checkpoint inhibitor due to toxicity,” even if it is minor.
Exploring evidence surrounding the optimal duration of therapy, session cochair Bishal Gyawali, MD, PhD, Queen’s University, Kingston, Canada, pointed to collaborative studies in colon cancer that looked at chemotherapy duration, for example looking at 3 versus 6 months of treatment.
Dr. Gyawali wondered whether the same could be achieved in lung cancer to test the non-inferiority of shorter duration of immunotherapy versus continuing treatment until disease progression.
Dr. Goto noted that the biggest difference in the current context of NSCLC is the toxicity incurred by both the adjuvant chemotherapy and the immunotherapy, making the overall benefit to the patient “very difficult to show.” Consequently, patients may not be willing to join a randomized trial in which they could experience additional toxicity for uncertain benefit.
City of Hope oncologist H. Jack West, MD, who presented at the session, said he would “love to see more trials looking at de-escalation and seeing whether we do just as well on efficacy with lower toxicity and lower costs.”
Instead, “we are seeing reports of the fourth entrant into the field that just recapitulates things we already know,” which is “terribly disappointing.”
“I really wish we could vote with our feet more and not participate in trials that are completely redundant compared to what we’ve had for years already,” Dr. West said.
No funding for this study was declared. Dr. Goto disclosed relationships with AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Guardant Health, Illumina, Kyorin, MSD, Novartis, Ono Pharmaceutical, Pfizer, Shionogi Pharma, and Taiho Pharmaceutical. Dr. West disclosed relationships with AstraZeneca, EQRx, Genentech/Roche, Merck, Mirati, and Regeneron and is a regular contributor to Medscape Oncology.
A version of this article first appeared on Medscape.com.
However, the research to date does not provide a clear picture of which patients will achieve this “exceptional and durable response” and at which point patients can safely reduce or withdraw from treatment, according to Yasushi Goto, MD, PhD, a staff doctor in the Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
Dr. Goto presented the latest evidence and explored the current unknowns surrounding immunotherapy de-escalation in NSCLC in a session this week at the virtual World Conference on Lung Cancer.
In addition to a toxicity and quality-of-life benefit for patients, immunotherapy de-escalation could have a significant impact on the costs of care, Dr. Goto stressed. The rising cost of new cancer treatments represents a “crisis” in terms of the affordability of health care, he said, and reducing these costs represents an “urgent global issue.”
Evidence on discontinuing treatment
Dr. Goto kicked off the session by emphasizing how drastically immunotherapy has enhanced outcomes for patients with NSCLC and other cancers.
This success has brought a pressing clinical question to the forefront: How long should we treat patients with immunotherapy?
The question arose over 10 years ago when ipilimumab (Yervoy) was granted FDA approval for patients with metastatic melanoma, but only for a total of four doses because of the drug’s toxicity.
“However, some patients had very lasting efficacy with the drug, even after discontinuation,” Dr. Goto said, which raised the exciting prospect that patients could achieve a functional cure with immunotherapy.
Evidence highlighting this lasting effect among patients with NSCLC soon emerged as well. A 2015 study, for instance, indicated that, despite toxicities, 50% of patients receiving nivolumab (Opdivo) continued to have a treatment effect more than 9 months after their last dose.
A 2021 analysis of patients receiving pembrolizumab (Keytruda) found that 48% of patients were disease-free after 5 years, despite having discontinued treatment after 2 years.
These investigators also found that toxicities accumulated over time – new grade greater than or equal to three toxicities occurred in 10% of patients every 6 months – which makes it particularly important to consider limiting the duration of therapy, Dr. Goto noted.
Only one randomized study to date – the CheckMate 153 trial – has explicitly explored outcomes associated with discontinuing immunotherapy in patients with NSCLC. In this study, patients still receiving nivolumab after 1 year were randomized to continue or stop therapy. Both median progression-free survival and overall survival were significantly longer in patients who continued therapy versus those who stopped at 1 year.
However, Dr. Goto noted that limitations in the study design, including the fact that many patients were censored at an early stage, made the results “nonconfirmatory” and he would like to see more data.
The role of re-treatment
Finding the optimal time to discontinue treatment is critical but even if patients stop treatment before they achieve long-lasting benefits, they can still be retreated successfully.
Two recent studies examined the potential benefits of re-treatment. In the 2021 KEYNOTE-010 analysis, 21 patients received a second course of pembrolizumab, at a response rate of 53% and a disease control rate of 81%.
In another recent study, investigators found that among 78 patients with melanoma who had discontinued either nivolumab or pembrolizumab and were re-treated after disease progression, 15% (5 of 34) receiving a single anti-PD-1 agent responded to retreatment and 25% (11 of 44) escalated to nivolumab plus ipilimumab exhibited a response.
Dr. Goto noted that there are also ongoing randomized studies examining the optimal duration of immunotherapy in advanced melanoma. One that he is involved in, the SAVE study, is enrolling patients with advanced NSCLC who have responded to anti-PD-1 agents for over a year and will compare overall survival in those who stop therapy versus those who continue. In addition, given the “growing importance” of biomarkers as a prediction tool, Dr. Goto plans to integrate circulating tumor DNA testing to help identify patients more likely to benefit from therapy discontinuation.
If successful, such approaches could “disruptively decrease prescribing costs,” by lowering doses or dose frequency, shortening the treatment duration, or by substituting therapies with fewer adverse effects, Dr. Goto said.
Discussing de-escalation in practice
During the discussion period after his talk, session co-chair Loretta Erhunmwunsee, MD, City of Hope Comprehensive Cancer Center, Duarte, California, asked Dr. Goto what his current practice is in regard to de-escalation.
He replied that, in Japan, physicians are allowed to continue immunotherapy beyond 2 years, but “many patients stop their immune checkpoint inhibitor due to toxicity,” even if it is minor.
Exploring evidence surrounding the optimal duration of therapy, session cochair Bishal Gyawali, MD, PhD, Queen’s University, Kingston, Canada, pointed to collaborative studies in colon cancer that looked at chemotherapy duration, for example looking at 3 versus 6 months of treatment.
Dr. Gyawali wondered whether the same could be achieved in lung cancer to test the non-inferiority of shorter duration of immunotherapy versus continuing treatment until disease progression.
Dr. Goto noted that the biggest difference in the current context of NSCLC is the toxicity incurred by both the adjuvant chemotherapy and the immunotherapy, making the overall benefit to the patient “very difficult to show.” Consequently, patients may not be willing to join a randomized trial in which they could experience additional toxicity for uncertain benefit.
City of Hope oncologist H. Jack West, MD, who presented at the session, said he would “love to see more trials looking at de-escalation and seeing whether we do just as well on efficacy with lower toxicity and lower costs.”
Instead, “we are seeing reports of the fourth entrant into the field that just recapitulates things we already know,” which is “terribly disappointing.”
“I really wish we could vote with our feet more and not participate in trials that are completely redundant compared to what we’ve had for years already,” Dr. West said.
No funding for this study was declared. Dr. Goto disclosed relationships with AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Guardant Health, Illumina, Kyorin, MSD, Novartis, Ono Pharmaceutical, Pfizer, Shionogi Pharma, and Taiho Pharmaceutical. Dr. West disclosed relationships with AstraZeneca, EQRx, Genentech/Roche, Merck, Mirati, and Regeneron and is a regular contributor to Medscape Oncology.
A version of this article first appeared on Medscape.com.
Tackling grief, loss in patients with advanced lung cancer
Patients with life-limiting advanced lung cancer often experience intense grief and loss.
Palliative care aims “to anticipate, prevent, and reduce suffering, promote adaptive coping, and support the best possible quality of life ... regardless of the stage of the disease or the need for other therapies,” commented Andreas Charalambous, RN, PhD, assistant professor (acting) of oncology and palliative care at the Cyprus University of Technology in Limassol, Cyprus.
He was speaking at the 2021 World Conference on Lung Cancer, where he chaired a special session entitled, “Grief and Loss in Palliative Care.”
Research shows that the use of palliative care is associated with improved quality of life and lower costs of care for patients with cancer. But a 2015 Palliative Care Survey by the National Comprehensive Cancer Network found that although the majority of leading U.S. cancer centers have inpatient palliative care services, most reported insufficient capacity to meet the demand, and that home-based palliative care services and inpatient units were much less common.
Dr. Charalambous emphasized the importance of enhancing the use and quality of palliative care services for patients with advanced lung cancer.
During the session, experts discussed an array of strategies geared towards relieving physical symptoms as well as psychological and spiritual stressors.
Physical activity: Establishing what’s possible
Grief and loss are “natural and normal” reactions to advanced cancer, commented Celia Marston, MPallCare, clinical lead for occupational therapy at Peter MacCallum Cancer Centre in Melbourne, Australia.
Patients experience feelings of loss around their independence, relationships, physical and cognitive functioning, which in turn impacts their sense of identity, daily routines, and plans for the future.
According to Ms. Marston, the rapid physical decline patients experience in the last 3 months of life is particularly “distressing,” which is why helping patients continue to perform everyday tasks is so critical.
In clinical practice, this means providing patients palliative rehabilitation focused on maintaining at least a degree of their normal physical activity, which allows them “to adjust and contend with that decline,” Ms. Marston said. It also requires understanding what is important to patients and supporting those requests.
According to Ms. Marston, optimizing patient function can help maintain or slow that rate of physical decline, or sometimes improve it. But even partial activity can be “equally if not more important” than full participation in an activity. Patients “want to be active, they want to test what they can and can’t do” and establish what is possible, she said.
Nonpharmacological approaches to symptom control
Addressing strategies to relieve physical symptoms in patients with lung cancer, Alex Molassiotis, RN, PhD, chair professor of nursing at Hong Kong Polytechnic University, explored the role nonpharmacological interventions can play.
Dr. Molassiotis highlighted the 2021 American Society of Clinical Oncology guidelines for the Management of Dyspnea in Advanced Cancer, which discuss a range of nonpharmacological strategies to manage respiratory distress, in particular. These include supplemental oxygen and noninvasive ventilation as well as breathing techniques, posture, relaxation, meditation, physical and music therapy, and acupressure or reflexology.
In a 2015 randomized controlled feasibility trial, Dr. Molassiotis explored the effectiveness of one such strategy – inspiratory muscle training – in patients with lung cancer and reported improvements in the respiratory symptom cluster of breathlessness, cough, and fatigue. A 2020 trial of breathing retraining and psychosocial support for managing dyspnea in patients with lung cancer or mesothelioma also showed the intervention improved average dyspnea, control over dyspnea, and anxiety.
However, Dr. Molassiotis cautioned, many other nonpharmacological interventions have only “limited” evidence of effectiveness, and a “stronger evidence base” is required.
Physicians should nevertheless talk to patients about their respiratory symptoms and discuss the available options, taking into account the “major impact” these symptoms have on their quality of life.
Integrating psychological strategies
More than 40% of patients with advanced nonsmall cell lung cancer experience moderate to severe death anxiety, and about one in four patients with any stage of lung cancer experience significant depression and demoralization, research shows.
During the session, Gary Rodin, MD, of the Princess Margaret Cancer Centre in Toronto, stressed the “need to intervene” and outlined approaches relevant to different stages of the disease journey.
At the onset, he said, Emotion and Symptom-Focused Engagement (EASE) can help relieve patients’ physical symptoms and traumatic stress. Those with more advanced disease can receive Meaning-Centered Psychotherapy, or Managing Cancer and Living Meaningfully (CALM), which Dr. Rodin and his colleague Sarah Hales, MD, PhD, developed. And patients at the end of life may benefit from Dignity Therapy, a short form of psychotherapy focused on helping patients find comfort and meaning in their final days.
Dr. Rodin focused on the role of CALM for those with advanced disease. CALM encompasses three to six sessions of a semi-structured intervention given over several months. The intervention focuses on four domains: 1. Symptom management and communication with healthcare providers; 2. Changes in oneself and relationships with others; 3. Spirituality, or finding a sense of meaning and purpose; and 4. Approaches to sustain hope and face mortality.
Dr. Rodin led a 2018 randomized trial comparing CALM with usual care, which showed the intervention was associated with significant reductions in depression symptoms and death anxiety in patients with advanced cancer at three and six months, as well as better patient communication and preparedness for the end of life. Patients reported that the intervention gave them “complete freedom” to communicate about themselves, their condition, and their life.
Evidence-based psychological interventions “should be offered as standard of care” to patients with lung cancer, Dr. Rodin said.
Enhancing patient-doctor communication
Having conversations early on about the goals of cancer care is particularly critical, according to Rachelle E. Bernacki, MD, director of quality initiatives, psychosocial oncology, and palliative care at the Dana-Farber Cancer Institute.
These conversations between physicians, patients, and family members give patients and loved ones time to make informed decisions, improve patients’ quality of care and satisfaction, and increase the likelihood of using hospice care, Dr. Bernacki explained.
But the reality is that these conversations don’t happen often enough. Less than one third of patients with end-stage diagnoses reported having an end-of-life discussion with their physician, and when the topic does arise, it is typically a few weeks before a patient passes away.
Moreover, these conversations “often fail to address key elements of quality discussions,” Dr. Bernacki commented.
Part of the problem is that many doctors lack the necessary training, face time constraints, or are uncertain about when or how to initiate these conversations.
Although challenging, patients want to have these discussions. Nine of 10 Americans believe doctors should talk about end-of-life issues with their patients, and 75% of older patients want to know their prognosis so they can prepare for the future, make informed medical decisions, and optimize the time they have left.
Dr. Bernacki highlighted a framework that can help clinicians have productive end-of-life conversations with patients. The Serious Illness Conversation Guide, developed by Ariadne Labs and the Dana-Farber Cancer Institute, outlines key steps, which include scheduling the conversation, delivering a prognosis, and exploring what matters to the patient. The guide also explores how to communicate effectively with patients, such as asking permission and clarifying questions as well as engaging in active listening.
Above all, Dr. Bernacki stressed that physicians should “listen more than talk” and avoid providing premature assurance when addressing the prognosis. “Many fears will arise that cannot be fixed, but talking about them makes them more bearable for the patient,” she said.
Physicians experience grief, too
Patients with advanced lung cancer are not the only ones who face loss and distress. More than half of physicians treating terminally ill patients can experience burnout, according to Sonia Oyola, MD, assistant professor of family medicine at the University of Chicago Medicine.
In her presentation, Dr. Oyola highlighted strategies physicians can use to manage their grief.
The first step is simply acknowledging feelings of loss. But every physician will have a “unique way of grieving and caring for themselves,” she said.
In general, the literature supports several approaches for managing grief: engaging in death talks and self-attunement or personal awareness training as well as providing end-of-life education in medical schools.
On the personal awareness front, Dr. Oyola highlighted a narrative medicine exercise where physicians write about the patient and reflect on what moved or touched them, what surprised them, and what inspired them.
Pursuing this kind of exercise allows physicians to reflect on their experiences in a way “we often do not have the opportunity to do” and could prevent some of the “devastating consequences in our practices, such as burnout,” Dr. Oyola said.
No funding declared. Dr. Molassiotis has reported a relationship with Helsinn. No other relevant financial relationships declared.
A version of this article first appeared on Medscape.com.
Patients with life-limiting advanced lung cancer often experience intense grief and loss.
Palliative care aims “to anticipate, prevent, and reduce suffering, promote adaptive coping, and support the best possible quality of life ... regardless of the stage of the disease or the need for other therapies,” commented Andreas Charalambous, RN, PhD, assistant professor (acting) of oncology and palliative care at the Cyprus University of Technology in Limassol, Cyprus.
He was speaking at the 2021 World Conference on Lung Cancer, where he chaired a special session entitled, “Grief and Loss in Palliative Care.”
Research shows that the use of palliative care is associated with improved quality of life and lower costs of care for patients with cancer. But a 2015 Palliative Care Survey by the National Comprehensive Cancer Network found that although the majority of leading U.S. cancer centers have inpatient palliative care services, most reported insufficient capacity to meet the demand, and that home-based palliative care services and inpatient units were much less common.
Dr. Charalambous emphasized the importance of enhancing the use and quality of palliative care services for patients with advanced lung cancer.
During the session, experts discussed an array of strategies geared towards relieving physical symptoms as well as psychological and spiritual stressors.
Physical activity: Establishing what’s possible
Grief and loss are “natural and normal” reactions to advanced cancer, commented Celia Marston, MPallCare, clinical lead for occupational therapy at Peter MacCallum Cancer Centre in Melbourne, Australia.
Patients experience feelings of loss around their independence, relationships, physical and cognitive functioning, which in turn impacts their sense of identity, daily routines, and plans for the future.
According to Ms. Marston, the rapid physical decline patients experience in the last 3 months of life is particularly “distressing,” which is why helping patients continue to perform everyday tasks is so critical.
In clinical practice, this means providing patients palliative rehabilitation focused on maintaining at least a degree of their normal physical activity, which allows them “to adjust and contend with that decline,” Ms. Marston said. It also requires understanding what is important to patients and supporting those requests.
According to Ms. Marston, optimizing patient function can help maintain or slow that rate of physical decline, or sometimes improve it. But even partial activity can be “equally if not more important” than full participation in an activity. Patients “want to be active, they want to test what they can and can’t do” and establish what is possible, she said.
Nonpharmacological approaches to symptom control
Addressing strategies to relieve physical symptoms in patients with lung cancer, Alex Molassiotis, RN, PhD, chair professor of nursing at Hong Kong Polytechnic University, explored the role nonpharmacological interventions can play.
Dr. Molassiotis highlighted the 2021 American Society of Clinical Oncology guidelines for the Management of Dyspnea in Advanced Cancer, which discuss a range of nonpharmacological strategies to manage respiratory distress, in particular. These include supplemental oxygen and noninvasive ventilation as well as breathing techniques, posture, relaxation, meditation, physical and music therapy, and acupressure or reflexology.
In a 2015 randomized controlled feasibility trial, Dr. Molassiotis explored the effectiveness of one such strategy – inspiratory muscle training – in patients with lung cancer and reported improvements in the respiratory symptom cluster of breathlessness, cough, and fatigue. A 2020 trial of breathing retraining and psychosocial support for managing dyspnea in patients with lung cancer or mesothelioma also showed the intervention improved average dyspnea, control over dyspnea, and anxiety.
However, Dr. Molassiotis cautioned, many other nonpharmacological interventions have only “limited” evidence of effectiveness, and a “stronger evidence base” is required.
Physicians should nevertheless talk to patients about their respiratory symptoms and discuss the available options, taking into account the “major impact” these symptoms have on their quality of life.
Integrating psychological strategies
More than 40% of patients with advanced nonsmall cell lung cancer experience moderate to severe death anxiety, and about one in four patients with any stage of lung cancer experience significant depression and demoralization, research shows.
During the session, Gary Rodin, MD, of the Princess Margaret Cancer Centre in Toronto, stressed the “need to intervene” and outlined approaches relevant to different stages of the disease journey.
At the onset, he said, Emotion and Symptom-Focused Engagement (EASE) can help relieve patients’ physical symptoms and traumatic stress. Those with more advanced disease can receive Meaning-Centered Psychotherapy, or Managing Cancer and Living Meaningfully (CALM), which Dr. Rodin and his colleague Sarah Hales, MD, PhD, developed. And patients at the end of life may benefit from Dignity Therapy, a short form of psychotherapy focused on helping patients find comfort and meaning in their final days.
Dr. Rodin focused on the role of CALM for those with advanced disease. CALM encompasses three to six sessions of a semi-structured intervention given over several months. The intervention focuses on four domains: 1. Symptom management and communication with healthcare providers; 2. Changes in oneself and relationships with others; 3. Spirituality, or finding a sense of meaning and purpose; and 4. Approaches to sustain hope and face mortality.
Dr. Rodin led a 2018 randomized trial comparing CALM with usual care, which showed the intervention was associated with significant reductions in depression symptoms and death anxiety in patients with advanced cancer at three and six months, as well as better patient communication and preparedness for the end of life. Patients reported that the intervention gave them “complete freedom” to communicate about themselves, their condition, and their life.
Evidence-based psychological interventions “should be offered as standard of care” to patients with lung cancer, Dr. Rodin said.
Enhancing patient-doctor communication
Having conversations early on about the goals of cancer care is particularly critical, according to Rachelle E. Bernacki, MD, director of quality initiatives, psychosocial oncology, and palliative care at the Dana-Farber Cancer Institute.
These conversations between physicians, patients, and family members give patients and loved ones time to make informed decisions, improve patients’ quality of care and satisfaction, and increase the likelihood of using hospice care, Dr. Bernacki explained.
But the reality is that these conversations don’t happen often enough. Less than one third of patients with end-stage diagnoses reported having an end-of-life discussion with their physician, and when the topic does arise, it is typically a few weeks before a patient passes away.
Moreover, these conversations “often fail to address key elements of quality discussions,” Dr. Bernacki commented.
Part of the problem is that many doctors lack the necessary training, face time constraints, or are uncertain about when or how to initiate these conversations.
Although challenging, patients want to have these discussions. Nine of 10 Americans believe doctors should talk about end-of-life issues with their patients, and 75% of older patients want to know their prognosis so they can prepare for the future, make informed medical decisions, and optimize the time they have left.
Dr. Bernacki highlighted a framework that can help clinicians have productive end-of-life conversations with patients. The Serious Illness Conversation Guide, developed by Ariadne Labs and the Dana-Farber Cancer Institute, outlines key steps, which include scheduling the conversation, delivering a prognosis, and exploring what matters to the patient. The guide also explores how to communicate effectively with patients, such as asking permission and clarifying questions as well as engaging in active listening.
Above all, Dr. Bernacki stressed that physicians should “listen more than talk” and avoid providing premature assurance when addressing the prognosis. “Many fears will arise that cannot be fixed, but talking about them makes them more bearable for the patient,” she said.
Physicians experience grief, too
Patients with advanced lung cancer are not the only ones who face loss and distress. More than half of physicians treating terminally ill patients can experience burnout, according to Sonia Oyola, MD, assistant professor of family medicine at the University of Chicago Medicine.
In her presentation, Dr. Oyola highlighted strategies physicians can use to manage their grief.
The first step is simply acknowledging feelings of loss. But every physician will have a “unique way of grieving and caring for themselves,” she said.
In general, the literature supports several approaches for managing grief: engaging in death talks and self-attunement or personal awareness training as well as providing end-of-life education in medical schools.
On the personal awareness front, Dr. Oyola highlighted a narrative medicine exercise where physicians write about the patient and reflect on what moved or touched them, what surprised them, and what inspired them.
Pursuing this kind of exercise allows physicians to reflect on their experiences in a way “we often do not have the opportunity to do” and could prevent some of the “devastating consequences in our practices, such as burnout,” Dr. Oyola said.
No funding declared. Dr. Molassiotis has reported a relationship with Helsinn. No other relevant financial relationships declared.
A version of this article first appeared on Medscape.com.
Patients with life-limiting advanced lung cancer often experience intense grief and loss.
Palliative care aims “to anticipate, prevent, and reduce suffering, promote adaptive coping, and support the best possible quality of life ... regardless of the stage of the disease or the need for other therapies,” commented Andreas Charalambous, RN, PhD, assistant professor (acting) of oncology and palliative care at the Cyprus University of Technology in Limassol, Cyprus.
He was speaking at the 2021 World Conference on Lung Cancer, where he chaired a special session entitled, “Grief and Loss in Palliative Care.”
Research shows that the use of palliative care is associated with improved quality of life and lower costs of care for patients with cancer. But a 2015 Palliative Care Survey by the National Comprehensive Cancer Network found that although the majority of leading U.S. cancer centers have inpatient palliative care services, most reported insufficient capacity to meet the demand, and that home-based palliative care services and inpatient units were much less common.
Dr. Charalambous emphasized the importance of enhancing the use and quality of palliative care services for patients with advanced lung cancer.
During the session, experts discussed an array of strategies geared towards relieving physical symptoms as well as psychological and spiritual stressors.
Physical activity: Establishing what’s possible
Grief and loss are “natural and normal” reactions to advanced cancer, commented Celia Marston, MPallCare, clinical lead for occupational therapy at Peter MacCallum Cancer Centre in Melbourne, Australia.
Patients experience feelings of loss around their independence, relationships, physical and cognitive functioning, which in turn impacts their sense of identity, daily routines, and plans for the future.
According to Ms. Marston, the rapid physical decline patients experience in the last 3 months of life is particularly “distressing,” which is why helping patients continue to perform everyday tasks is so critical.
In clinical practice, this means providing patients palliative rehabilitation focused on maintaining at least a degree of their normal physical activity, which allows them “to adjust and contend with that decline,” Ms. Marston said. It also requires understanding what is important to patients and supporting those requests.
According to Ms. Marston, optimizing patient function can help maintain or slow that rate of physical decline, or sometimes improve it. But even partial activity can be “equally if not more important” than full participation in an activity. Patients “want to be active, they want to test what they can and can’t do” and establish what is possible, she said.
Nonpharmacological approaches to symptom control
Addressing strategies to relieve physical symptoms in patients with lung cancer, Alex Molassiotis, RN, PhD, chair professor of nursing at Hong Kong Polytechnic University, explored the role nonpharmacological interventions can play.
Dr. Molassiotis highlighted the 2021 American Society of Clinical Oncology guidelines for the Management of Dyspnea in Advanced Cancer, which discuss a range of nonpharmacological strategies to manage respiratory distress, in particular. These include supplemental oxygen and noninvasive ventilation as well as breathing techniques, posture, relaxation, meditation, physical and music therapy, and acupressure or reflexology.
In a 2015 randomized controlled feasibility trial, Dr. Molassiotis explored the effectiveness of one such strategy – inspiratory muscle training – in patients with lung cancer and reported improvements in the respiratory symptom cluster of breathlessness, cough, and fatigue. A 2020 trial of breathing retraining and psychosocial support for managing dyspnea in patients with lung cancer or mesothelioma also showed the intervention improved average dyspnea, control over dyspnea, and anxiety.
However, Dr. Molassiotis cautioned, many other nonpharmacological interventions have only “limited” evidence of effectiveness, and a “stronger evidence base” is required.
Physicians should nevertheless talk to patients about their respiratory symptoms and discuss the available options, taking into account the “major impact” these symptoms have on their quality of life.
Integrating psychological strategies
More than 40% of patients with advanced nonsmall cell lung cancer experience moderate to severe death anxiety, and about one in four patients with any stage of lung cancer experience significant depression and demoralization, research shows.
During the session, Gary Rodin, MD, of the Princess Margaret Cancer Centre in Toronto, stressed the “need to intervene” and outlined approaches relevant to different stages of the disease journey.
At the onset, he said, Emotion and Symptom-Focused Engagement (EASE) can help relieve patients’ physical symptoms and traumatic stress. Those with more advanced disease can receive Meaning-Centered Psychotherapy, or Managing Cancer and Living Meaningfully (CALM), which Dr. Rodin and his colleague Sarah Hales, MD, PhD, developed. And patients at the end of life may benefit from Dignity Therapy, a short form of psychotherapy focused on helping patients find comfort and meaning in their final days.
Dr. Rodin focused on the role of CALM for those with advanced disease. CALM encompasses three to six sessions of a semi-structured intervention given over several months. The intervention focuses on four domains: 1. Symptom management and communication with healthcare providers; 2. Changes in oneself and relationships with others; 3. Spirituality, or finding a sense of meaning and purpose; and 4. Approaches to sustain hope and face mortality.
Dr. Rodin led a 2018 randomized trial comparing CALM with usual care, which showed the intervention was associated with significant reductions in depression symptoms and death anxiety in patients with advanced cancer at three and six months, as well as better patient communication and preparedness for the end of life. Patients reported that the intervention gave them “complete freedom” to communicate about themselves, their condition, and their life.
Evidence-based psychological interventions “should be offered as standard of care” to patients with lung cancer, Dr. Rodin said.
Enhancing patient-doctor communication
Having conversations early on about the goals of cancer care is particularly critical, according to Rachelle E. Bernacki, MD, director of quality initiatives, psychosocial oncology, and palliative care at the Dana-Farber Cancer Institute.
These conversations between physicians, patients, and family members give patients and loved ones time to make informed decisions, improve patients’ quality of care and satisfaction, and increase the likelihood of using hospice care, Dr. Bernacki explained.
But the reality is that these conversations don’t happen often enough. Less than one third of patients with end-stage diagnoses reported having an end-of-life discussion with their physician, and when the topic does arise, it is typically a few weeks before a patient passes away.
Moreover, these conversations “often fail to address key elements of quality discussions,” Dr. Bernacki commented.
Part of the problem is that many doctors lack the necessary training, face time constraints, or are uncertain about when or how to initiate these conversations.
Although challenging, patients want to have these discussions. Nine of 10 Americans believe doctors should talk about end-of-life issues with their patients, and 75% of older patients want to know their prognosis so they can prepare for the future, make informed medical decisions, and optimize the time they have left.
Dr. Bernacki highlighted a framework that can help clinicians have productive end-of-life conversations with patients. The Serious Illness Conversation Guide, developed by Ariadne Labs and the Dana-Farber Cancer Institute, outlines key steps, which include scheduling the conversation, delivering a prognosis, and exploring what matters to the patient. The guide also explores how to communicate effectively with patients, such as asking permission and clarifying questions as well as engaging in active listening.
Above all, Dr. Bernacki stressed that physicians should “listen more than talk” and avoid providing premature assurance when addressing the prognosis. “Many fears will arise that cannot be fixed, but talking about them makes them more bearable for the patient,” she said.
Physicians experience grief, too
Patients with advanced lung cancer are not the only ones who face loss and distress. More than half of physicians treating terminally ill patients can experience burnout, according to Sonia Oyola, MD, assistant professor of family medicine at the University of Chicago Medicine.
In her presentation, Dr. Oyola highlighted strategies physicians can use to manage their grief.
The first step is simply acknowledging feelings of loss. But every physician will have a “unique way of grieving and caring for themselves,” she said.
In general, the literature supports several approaches for managing grief: engaging in death talks and self-attunement or personal awareness training as well as providing end-of-life education in medical schools.
On the personal awareness front, Dr. Oyola highlighted a narrative medicine exercise where physicians write about the patient and reflect on what moved or touched them, what surprised them, and what inspired them.
Pursuing this kind of exercise allows physicians to reflect on their experiences in a way “we often do not have the opportunity to do” and could prevent some of the “devastating consequences in our practices, such as burnout,” Dr. Oyola said.
No funding declared. Dr. Molassiotis has reported a relationship with Helsinn. No other relevant financial relationships declared.
A version of this article first appeared on Medscape.com.
Top 10 things to know about the AHA ACLS 2020 updates
Plus, how things differ in a COVID-19 cardiac arrest case
Top 10 things to know about the AHA ACLS 2020 updates1
1. There were no changes to the 2015 cardiac arrest algorithms.
2. The 2020 adult bradycardia algorithm increased the atropine dose to 1 mg (from 0.5-1 mg) but maintains the same frequency of dosing as every 3-5 minutes with max dose of 3 mg.
3. Epinephrine was reaffirmed. Specifically, give epinephrine as soon as possible in nonshockable rhythms (pulseless electrical activity and asystole). In shockable rhythms (ventricular fibrillation and pulseless ventricular tachycardia), the timing is less clear but it is reasonable to give the first dose after initial defibrillation attempts have failed. Currently the shockable rhythms algorithm has the first dose of epinephrine given after the second shock.
4. Giving medications intravenously is preferred over intraosseous (IO) cannulation because of some small observational studies that showed worsened outcomes with IO delivery. Try to get an IV if possible, but can still use IO if necessary. Central venous catheters are still not recommended during a code unless no other access can be obtained.
5. Double sequential defibrillation in refractory VF, which is the application of two sets of pads using two defibrillators to provide defibrillation either in rapid succession or at the same time, is not recommended because of lack of evidence.
6. It is reasonable to use physiological parameters such as arterial blood pressure or end-tidal CO2 (EtCO2) to monitor CPR quality. Goal EtCO2 is greater than 10 but ideally greater 20 mm Hg, so if you’re not reaching that ideal goal, push harder and/or faster! Of note, to use arterial blood pressure monitoring you must have an arterial line in place and to get adequate EtCO2 monitoring, the patient must be intubated with an EtCO2 monitor attached.
7. The need for intubation and the ideal timing are still unknown. The American Heart Association recommends either bag valve mask or an advanced airway.
8. In pregnant patients who develop cardiac arrest, focus on high-quality CPR and relief of aortocaval compression through left lateral uterine displacement while the patient is supine. This means that someone on the team stands on the left side of the patient and cups the uterus, pulling it up and leftward. Alternately, if standing on the right of the patient, push the uterus left and upward off of the maternal vessels.
9. AHA released new algorithms for opioid overdose given the current crisis. There is an absence of proven naloxone benefit in cardiac arrest so focus on standard resuscitative efforts and do not wait for effects of naloxone before initiating CPR. However, naloxone is still reasonable to give if overdose is suspected.
10. Clinicians should wait a minimum of 72 hours after return to normothermia before performing multimodal neuroprognostication. This allows for confounding factors (that is, meds) to hopefully be removed for improved accuracy.
Top 5 things that differ in a COVID-19+/PUI cardiac arrest case2
1. Don adequate personal protective equipment prior to entering the room. This might create a necessary delay in care.
2. Use a high-efficiency particulate air (HEPA) filter on all airway modalities.
3. Intubate as early as possible by someone highly experienced and place the patient on a ventilator with HEPA filter while undergoing resuscitation. This decreases aerosolization risk.
4. Use a mechanical CPR device if possible. This results in less people needed in the room.
5. If a patient is NOT intubated but is prone when they arrest, safely turn them supine and perform resuscitative effort. If a patient is intubated and prone when they arrest: If unable to safely turn them, place the pads in the AP position and perform compressions over T7-T10 vertebral bodies. Evidence for this is extremely limited but comes from a small pilot study which showed that reverse CPR generated a higher mean arterial pressure, compared with standard resuscitation.3
Dr. Allen is assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.
References
1. Merchant RM et al. Part 1: Executive Summary: 2020 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2020 Oct 21;142:S337-57. doi: 10.1161/CIR.0000000000000918.
2. Edelson DP et al. Interim guidance for basic and advanced life support in adults, children, and neonates with suspected or confirmed COVID-19. 2020 Jun 23;141(25):e933-43. doi: 10.1161/CIRCULATIONAHA.120.047463.
3. Mazer SP et al. Reverse CPR: A pilot study of CPR in the prone position. Resuscitation. 2003 Jun;57(3):279-85. doi: 10.1016/s0300-9572(03)00037-6.
Plus, how things differ in a COVID-19 cardiac arrest case
Plus, how things differ in a COVID-19 cardiac arrest case
Top 10 things to know about the AHA ACLS 2020 updates1
1. There were no changes to the 2015 cardiac arrest algorithms.
2. The 2020 adult bradycardia algorithm increased the atropine dose to 1 mg (from 0.5-1 mg) but maintains the same frequency of dosing as every 3-5 minutes with max dose of 3 mg.
3. Epinephrine was reaffirmed. Specifically, give epinephrine as soon as possible in nonshockable rhythms (pulseless electrical activity and asystole). In shockable rhythms (ventricular fibrillation and pulseless ventricular tachycardia), the timing is less clear but it is reasonable to give the first dose after initial defibrillation attempts have failed. Currently the shockable rhythms algorithm has the first dose of epinephrine given after the second shock.
4. Giving medications intravenously is preferred over intraosseous (IO) cannulation because of some small observational studies that showed worsened outcomes with IO delivery. Try to get an IV if possible, but can still use IO if necessary. Central venous catheters are still not recommended during a code unless no other access can be obtained.
5. Double sequential defibrillation in refractory VF, which is the application of two sets of pads using two defibrillators to provide defibrillation either in rapid succession or at the same time, is not recommended because of lack of evidence.
6. It is reasonable to use physiological parameters such as arterial blood pressure or end-tidal CO2 (EtCO2) to monitor CPR quality. Goal EtCO2 is greater than 10 but ideally greater 20 mm Hg, so if you’re not reaching that ideal goal, push harder and/or faster! Of note, to use arterial blood pressure monitoring you must have an arterial line in place and to get adequate EtCO2 monitoring, the patient must be intubated with an EtCO2 monitor attached.
7. The need for intubation and the ideal timing are still unknown. The American Heart Association recommends either bag valve mask or an advanced airway.
8. In pregnant patients who develop cardiac arrest, focus on high-quality CPR and relief of aortocaval compression through left lateral uterine displacement while the patient is supine. This means that someone on the team stands on the left side of the patient and cups the uterus, pulling it up and leftward. Alternately, if standing on the right of the patient, push the uterus left and upward off of the maternal vessels.
9. AHA released new algorithms for opioid overdose given the current crisis. There is an absence of proven naloxone benefit in cardiac arrest so focus on standard resuscitative efforts and do not wait for effects of naloxone before initiating CPR. However, naloxone is still reasonable to give if overdose is suspected.
10. Clinicians should wait a minimum of 72 hours after return to normothermia before performing multimodal neuroprognostication. This allows for confounding factors (that is, meds) to hopefully be removed for improved accuracy.
Top 5 things that differ in a COVID-19+/PUI cardiac arrest case2
1. Don adequate personal protective equipment prior to entering the room. This might create a necessary delay in care.
2. Use a high-efficiency particulate air (HEPA) filter on all airway modalities.
3. Intubate as early as possible by someone highly experienced and place the patient on a ventilator with HEPA filter while undergoing resuscitation. This decreases aerosolization risk.
4. Use a mechanical CPR device if possible. This results in less people needed in the room.
5. If a patient is NOT intubated but is prone when they arrest, safely turn them supine and perform resuscitative effort. If a patient is intubated and prone when they arrest: If unable to safely turn them, place the pads in the AP position and perform compressions over T7-T10 vertebral bodies. Evidence for this is extremely limited but comes from a small pilot study which showed that reverse CPR generated a higher mean arterial pressure, compared with standard resuscitation.3
Dr. Allen is assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.
References
1. Merchant RM et al. Part 1: Executive Summary: 2020 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2020 Oct 21;142:S337-57. doi: 10.1161/CIR.0000000000000918.
2. Edelson DP et al. Interim guidance for basic and advanced life support in adults, children, and neonates with suspected or confirmed COVID-19. 2020 Jun 23;141(25):e933-43. doi: 10.1161/CIRCULATIONAHA.120.047463.
3. Mazer SP et al. Reverse CPR: A pilot study of CPR in the prone position. Resuscitation. 2003 Jun;57(3):279-85. doi: 10.1016/s0300-9572(03)00037-6.
Top 10 things to know about the AHA ACLS 2020 updates1
1. There were no changes to the 2015 cardiac arrest algorithms.
2. The 2020 adult bradycardia algorithm increased the atropine dose to 1 mg (from 0.5-1 mg) but maintains the same frequency of dosing as every 3-5 minutes with max dose of 3 mg.
3. Epinephrine was reaffirmed. Specifically, give epinephrine as soon as possible in nonshockable rhythms (pulseless electrical activity and asystole). In shockable rhythms (ventricular fibrillation and pulseless ventricular tachycardia), the timing is less clear but it is reasonable to give the first dose after initial defibrillation attempts have failed. Currently the shockable rhythms algorithm has the first dose of epinephrine given after the second shock.
4. Giving medications intravenously is preferred over intraosseous (IO) cannulation because of some small observational studies that showed worsened outcomes with IO delivery. Try to get an IV if possible, but can still use IO if necessary. Central venous catheters are still not recommended during a code unless no other access can be obtained.
5. Double sequential defibrillation in refractory VF, which is the application of two sets of pads using two defibrillators to provide defibrillation either in rapid succession or at the same time, is not recommended because of lack of evidence.
6. It is reasonable to use physiological parameters such as arterial blood pressure or end-tidal CO2 (EtCO2) to monitor CPR quality. Goal EtCO2 is greater than 10 but ideally greater 20 mm Hg, so if you’re not reaching that ideal goal, push harder and/or faster! Of note, to use arterial blood pressure monitoring you must have an arterial line in place and to get adequate EtCO2 monitoring, the patient must be intubated with an EtCO2 monitor attached.
7. The need for intubation and the ideal timing are still unknown. The American Heart Association recommends either bag valve mask or an advanced airway.
8. In pregnant patients who develop cardiac arrest, focus on high-quality CPR and relief of aortocaval compression through left lateral uterine displacement while the patient is supine. This means that someone on the team stands on the left side of the patient and cups the uterus, pulling it up and leftward. Alternately, if standing on the right of the patient, push the uterus left and upward off of the maternal vessels.
9. AHA released new algorithms for opioid overdose given the current crisis. There is an absence of proven naloxone benefit in cardiac arrest so focus on standard resuscitative efforts and do not wait for effects of naloxone before initiating CPR. However, naloxone is still reasonable to give if overdose is suspected.
10. Clinicians should wait a minimum of 72 hours after return to normothermia before performing multimodal neuroprognostication. This allows for confounding factors (that is, meds) to hopefully be removed for improved accuracy.
Top 5 things that differ in a COVID-19+/PUI cardiac arrest case2
1. Don adequate personal protective equipment prior to entering the room. This might create a necessary delay in care.
2. Use a high-efficiency particulate air (HEPA) filter on all airway modalities.
3. Intubate as early as possible by someone highly experienced and place the patient on a ventilator with HEPA filter while undergoing resuscitation. This decreases aerosolization risk.
4. Use a mechanical CPR device if possible. This results in less people needed in the room.
5. If a patient is NOT intubated but is prone when they arrest, safely turn them supine and perform resuscitative effort. If a patient is intubated and prone when they arrest: If unable to safely turn them, place the pads in the AP position and perform compressions over T7-T10 vertebral bodies. Evidence for this is extremely limited but comes from a small pilot study which showed that reverse CPR generated a higher mean arterial pressure, compared with standard resuscitation.3
Dr. Allen is assistant professor of medicine in the division of hospital medicine at Emory University, Atlanta.
References
1. Merchant RM et al. Part 1: Executive Summary: 2020 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2020 Oct 21;142:S337-57. doi: 10.1161/CIR.0000000000000918.
2. Edelson DP et al. Interim guidance for basic and advanced life support in adults, children, and neonates with suspected or confirmed COVID-19. 2020 Jun 23;141(25):e933-43. doi: 10.1161/CIRCULATIONAHA.120.047463.
3. Mazer SP et al. Reverse CPR: A pilot study of CPR in the prone position. Resuscitation. 2003 Jun;57(3):279-85. doi: 10.1016/s0300-9572(03)00037-6.
Acid series: Lactic acid
One of the most commonly used organic acids used on the skin, lactic acid, has been used for over 3 decades. Originally derived from milk or plant-derived sugars, this gentle exfoliating acid can be used in peels, serums, masks, and toners, and has the additional benefit of hydrating the skin. Lactic acid is formulated in concentrations from 2% to 50%; however, because of its large molecular size, it doesn’t penetrate the deeper layers of the dermis to the same extent as the other alpha-hydroxy acids (AHAs), such as glycolic acid. Thus, it is one of the gentler exfoliants and one that can be used in sensitive skin or darker skin types.
Despite its mild peeling effects, lactic acid is best used to treat xerotic skin because of its function as a humectant, drawing moisture into the stratum corneum. Similar to the other AHAs, lactic acid has also been shown to decrease melanogenesis and is a gentle treatment for skin hyperpigmentation, particularly in skin of color. Side effects include peeling, stinging, erythema, photosensitivity, and hyperpigmentation when improperly used.
Very little clinical research has been reported in the last 20 years as to the uses and benefits of lactic acid in skincare. In my clinical experience, daily use of lactic acid is more effective and has more long-term benefits for hydration and rejuvenation of the skin than the other AHAs. Concentrations of 10%-15% used daily on the skin as a mild exfoliant and humectant have shown to improve texture, decrease pigmentation and improve fine lines – without thinning of the skin seen with the deeper dermal penetrating acids.
Confusion in the market has also risen as many over-the-counter brands have included ammonium lactate in their portfolio of moisturizers. Ammonium lactate is a combination of ammonium hydroxide and lactic acid, or the salt of lactic acid. A comparative study evaluating the difference between 5% lactic acid and 12% ammonium lactate for the treatment of xerosis showed that ammonium lactate was significantly more effective at reducing xerosis. It is widely used in the treatment of keratosis pilaris, calluses, xerosis, and ichthyosis.
Widespread use of lactic acid has not gotten as much glory as that of glycolic acid. However, in clinical practice, its functions are more widespread. It is a much safer acid to use, and its added benefit of increasing hydration of the skin is crucial in its long-term use for both photoaging and the prevention of wrinkles. With any acid, the exfoliating properties must be treated with adequate hydration and barrier repair.
The intrinsic moisturizing effect of lactic acid makes it a much more well-rounded acid and that can be used for longer periods of time in a broader spectrum of patients.
Dr. Lily Talakoub and Dr. Naissan O. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
One of the most commonly used organic acids used on the skin, lactic acid, has been used for over 3 decades. Originally derived from milk or plant-derived sugars, this gentle exfoliating acid can be used in peels, serums, masks, and toners, and has the additional benefit of hydrating the skin. Lactic acid is formulated in concentrations from 2% to 50%; however, because of its large molecular size, it doesn’t penetrate the deeper layers of the dermis to the same extent as the other alpha-hydroxy acids (AHAs), such as glycolic acid. Thus, it is one of the gentler exfoliants and one that can be used in sensitive skin or darker skin types.
Despite its mild peeling effects, lactic acid is best used to treat xerotic skin because of its function as a humectant, drawing moisture into the stratum corneum. Similar to the other AHAs, lactic acid has also been shown to decrease melanogenesis and is a gentle treatment for skin hyperpigmentation, particularly in skin of color. Side effects include peeling, stinging, erythema, photosensitivity, and hyperpigmentation when improperly used.
Very little clinical research has been reported in the last 20 years as to the uses and benefits of lactic acid in skincare. In my clinical experience, daily use of lactic acid is more effective and has more long-term benefits for hydration and rejuvenation of the skin than the other AHAs. Concentrations of 10%-15% used daily on the skin as a mild exfoliant and humectant have shown to improve texture, decrease pigmentation and improve fine lines – without thinning of the skin seen with the deeper dermal penetrating acids.
Confusion in the market has also risen as many over-the-counter brands have included ammonium lactate in their portfolio of moisturizers. Ammonium lactate is a combination of ammonium hydroxide and lactic acid, or the salt of lactic acid. A comparative study evaluating the difference between 5% lactic acid and 12% ammonium lactate for the treatment of xerosis showed that ammonium lactate was significantly more effective at reducing xerosis. It is widely used in the treatment of keratosis pilaris, calluses, xerosis, and ichthyosis.
Widespread use of lactic acid has not gotten as much glory as that of glycolic acid. However, in clinical practice, its functions are more widespread. It is a much safer acid to use, and its added benefit of increasing hydration of the skin is crucial in its long-term use for both photoaging and the prevention of wrinkles. With any acid, the exfoliating properties must be treated with adequate hydration and barrier repair.
The intrinsic moisturizing effect of lactic acid makes it a much more well-rounded acid and that can be used for longer periods of time in a broader spectrum of patients.
Dr. Lily Talakoub and Dr. Naissan O. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
One of the most commonly used organic acids used on the skin, lactic acid, has been used for over 3 decades. Originally derived from milk or plant-derived sugars, this gentle exfoliating acid can be used in peels, serums, masks, and toners, and has the additional benefit of hydrating the skin. Lactic acid is formulated in concentrations from 2% to 50%; however, because of its large molecular size, it doesn’t penetrate the deeper layers of the dermis to the same extent as the other alpha-hydroxy acids (AHAs), such as glycolic acid. Thus, it is one of the gentler exfoliants and one that can be used in sensitive skin or darker skin types.
Despite its mild peeling effects, lactic acid is best used to treat xerotic skin because of its function as a humectant, drawing moisture into the stratum corneum. Similar to the other AHAs, lactic acid has also been shown to decrease melanogenesis and is a gentle treatment for skin hyperpigmentation, particularly in skin of color. Side effects include peeling, stinging, erythema, photosensitivity, and hyperpigmentation when improperly used.
Very little clinical research has been reported in the last 20 years as to the uses and benefits of lactic acid in skincare. In my clinical experience, daily use of lactic acid is more effective and has more long-term benefits for hydration and rejuvenation of the skin than the other AHAs. Concentrations of 10%-15% used daily on the skin as a mild exfoliant and humectant have shown to improve texture, decrease pigmentation and improve fine lines – without thinning of the skin seen with the deeper dermal penetrating acids.
Confusion in the market has also risen as many over-the-counter brands have included ammonium lactate in their portfolio of moisturizers. Ammonium lactate is a combination of ammonium hydroxide and lactic acid, or the salt of lactic acid. A comparative study evaluating the difference between 5% lactic acid and 12% ammonium lactate for the treatment of xerosis showed that ammonium lactate was significantly more effective at reducing xerosis. It is widely used in the treatment of keratosis pilaris, calluses, xerosis, and ichthyosis.
Widespread use of lactic acid has not gotten as much glory as that of glycolic acid. However, in clinical practice, its functions are more widespread. It is a much safer acid to use, and its added benefit of increasing hydration of the skin is crucial in its long-term use for both photoaging and the prevention of wrinkles. With any acid, the exfoliating properties must be treated with adequate hydration and barrier repair.
The intrinsic moisturizing effect of lactic acid makes it a much more well-rounded acid and that can be used for longer periods of time in a broader spectrum of patients.
Dr. Lily Talakoub and Dr. Naissan O. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.
Step-wise medical therapy is cost effective for endometriosis
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
For patients with endometriosis-related dysmenorrhea, it is cost effective to use medical therapy before surgery, according to investigators.
A stepwise strategy involving two medications, then surgery, was associated with the lowest cost per quality-adjusted life-years (QALYs), reported lead author, Jacqueline A. Bohn, MD, of Oregon Health & Science University, Portland, and colleagues.
“In 2009, the medical costs associated with endometriosis in the United States were estimated at $69.4 billion annually,” the investigators wrote in Obstetrics and Gynecology. “Despite the recognized cost burden of this disease, cost-effectiveness data on the various treatment strategies is limited. Previous studies have investigated the direct and indirect costs regarding endometriosis; however, there are no prior studies that evaluate the cost-effectiveness of a stepwise regimen to guide management.”
To fill this knowledge gap, Dr. Bohn and colleagues created a cost-effectiveness model comparing four treatment strategies:
NSAIDs, then surgery
NSAIDs, then short-acting reversible contraceptives or long-acting reversible contraceptives (LARCs), then surgery
NSAIDs, then a short-acting reversible contraceptive or a LARC, then a LARC or gonadotropin-releasing hormone (GnRH) modulator, then surgery
Surgery alone
The analysis, which compared costs, QALYs, and incremental cost-effectiveness ratios, involved a theoretical cohort of 4,817,894 women aged 18-45 years, representing the estimated number of reproductive-age women in the United States with endometriosis-related dysmenorrhea. Costs were determined from published literature and inflated to 2019 dollars. Medical treatments were theoretically given for 6 months each, and the cost of laparoscopic surgery incorporated 12 months of postoperative care.
Of the four strategies, the two-medication approach was most cost effective, with a cost per QALY of $1,158. This was followed closely by the three-medication regimen, at $1,158, the single-medication regimen, at $2,108, and finally, surgery alone, at $4,338.
“We found that, although cost effective, requiring trial of a third medication offered little comparative advantage before proceeding directly to surgery after the second therapy fails,” the investigators wrote. “Yet, for the woman who is anxious about surgical intervention, or when a prolonged wait for a surgical specialist occurs, trial of a GnRH modulator may be worthwhile.”
Compared with surgery alone, each regimen starting with medical therapy remained below the standard willingness-to-pay threshold of $100,000 per QALY; however, the investigators recommend against trying more than three medications.
“Delaying surgical management in a woman with pain refractory to more than three medications may decrease quality of life and further increase cost,” they wrote.
To make surgery alone the most cost-effective option, surgery success would need to exceed 83%, Dr. Bohn and colleagues concluded.
According to Hugh Taylor, MD, of Yale University, New Haven, Conn., it’s unlikely that this surgery success threshold will be met, since surgery alone typically leads to recurrence.
“We know there’s a very high relapse rate after surgery,” Dr. Taylor said in an interview. “Even if the surgery may be initially successful, there’s roughly a 50% recurrence rate after about 2 years. So, finding the right medical therapy will give you more chance for long-term success.”
Dr. Taylor said it’s “really nice” that Dr. Bohn and colleagues conducted a sequential analysis because the findings support the most common approach in real-world practice.
“It confirms that starting with a medical therapy prior to surgery is an appropriate, successful treatment for endometriosis, which is something that many, many people in the community do, but we haven’t had a real trial to show that,” he said.
Dr. Taylor offered two areas of improvement for similar studies in the future: First, he suggested separating LARCs from oral contraceptives because LARCs may be less effective for some patients with endometriosis; and second, he suggested that limiting the third medication to a GnRH antagonist would be more applicable to real-world practice than using the broader category of GnRH modulators.
Although the three-medication approach involving a GnRH modulator was slightly more expensive than the two-medication approach, Dr. Taylor said the costs were so similar that a three-medication approach is “still reasonable,” particularly because it could spare patients from surgery.
Dr. Taylor also speculated that trying a GnRH antagonist could become more cost effective soon. Although only one GnRH antagonist is currently on the market, he noted that a second agent is poised for Food and Drug Administration approval, while a third is in the pipeline, and this competition may decrease drug prices.
The investigators disclosed support from the National Institutes of Health, Arnold Ventures, the World Health Organization, Merck, and others. Dr. Taylor reported that Yale University receives funding for endometriosis biomarker research from AbbVie.
FROM OBSTETRICS & GYNECOLOGY
Acne Vulgaris
THE COMPARISON
A A 27-year-old Hispanic woman with comedonal and inflammatory acne. Erythema is prominent around the inflammatory lesions. Note the pustule on the cheek surrounded by pink color.
B A teenaged Black boy with acne papules and pustules on the face. There are comedones, hyperpigmented macules, and pustules on the cheek.
C A teenaged Black girl with pomade acne. The patient used various hair care products, which obstructed the pilosebaceous units on the forehead.
Epidemiology
Acne is a leading dermatologic condition in individuals with skin of color in the United States.1
Key clinical features in people with darker skin tones include:
- erythematous or hyperpigmented papules or comedones
- hyperpigmented macules and postinflammatory hyperpigmentation (PIH)
- increased risk for keloidal scars.2
Worth noting
- Patients with darker skin tones may be more concerned with the dark marks (also referred to as scars or manchas in Spanish) than the acne itself. This PIH may be viewed by patients as the major problem.
- Acne medications such as azelaic acid and some retinoids (when applied appropriately) can treat both acne and PIH.3
- Irritation from topical acne medications, including retinoid dermatitis, may lead to more PIH. Using noncomedogenic moisturizers and applying medication appropriately (ie, a pea-sized amount of topical retinoid per application) may help limit irritation.4,5
- One type of acne seen more commonly, although not exclusively, in Black patients is pomade acne, which principally appears on the forehead and is associated with use of hair care and styling products (Figure, C).
Health disparity highlight
Disparities in access to health care exist for those with dermatologic concerns. According to one study, African American (28.5%) and Hispanic patients (23.9%) were less likely to be seen by a dermatologist solely for the diagnosis of a dermatologic condition compared to Asian and Pacific Islander patients (36.7%) or White patients (43.2%).1
Noting that isotretinoin is the most potent systemic therapy for severe cystic acne vulgaris, Bell et al6 reported that Black patients had lower odds of receiving isotretinoin compared to White patients. Hispanic patients had lower odds of receiving a topical retinoid, tretinoin, than non-Hispanic patients.6
- Davis SA, Narahari S, Feldman SR, et al. Top dermatologic conditions in patients of color: an analysis of nationally representative data. J Drugs Dermatol. 2012;11:466-473.
- Alexis AF, Woolery-Lloyd H, Williams K, et al. Racial/ethnic variations in acne: implications for treatment and skin care recommendations for acne patients with skin of color. J Drugs Dermatol. 2021;20:716-725.
- Woolery-Lloyd HC, Keri J, Doig S. Retinoids and azelaic acid to treat acne and hyperpigmentation in skin of color. J Drugs Dermatol. 2013;12:434-437.
- Grayson C, Heath C. Tips for addressing common conditions affecting pediatric and adolescent patients with skin of color [published online March 2, 2021]. Pediatr Dermatol. doi:10.1111/pde.14525
- Alexis AD, Harper JC, Stein Gold L, et al. Treating acne in patients with skin of color. Semin Cutan Med Surg. 2018;37(suppl 3):S71-S73.
- Bell MA, Whang KA, Thomas J, et al. Racial and ethnic disparities in access to emerging and frontline therapies in common dermatological conditions: a cross-sectional study. J Natl Med Assoc. 2020;112:650-653.
THE COMPARISON
A A 27-year-old Hispanic woman with comedonal and inflammatory acne. Erythema is prominent around the inflammatory lesions. Note the pustule on the cheek surrounded by pink color.
B A teenaged Black boy with acne papules and pustules on the face. There are comedones, hyperpigmented macules, and pustules on the cheek.
C A teenaged Black girl with pomade acne. The patient used various hair care products, which obstructed the pilosebaceous units on the forehead.
Epidemiology
Acne is a leading dermatologic condition in individuals with skin of color in the United States.1
Key clinical features in people with darker skin tones include:
- erythematous or hyperpigmented papules or comedones
- hyperpigmented macules and postinflammatory hyperpigmentation (PIH)
- increased risk for keloidal scars.2
Worth noting
- Patients with darker skin tones may be more concerned with the dark marks (also referred to as scars or manchas in Spanish) than the acne itself. This PIH may be viewed by patients as the major problem.
- Acne medications such as azelaic acid and some retinoids (when applied appropriately) can treat both acne and PIH.3
- Irritation from topical acne medications, including retinoid dermatitis, may lead to more PIH. Using noncomedogenic moisturizers and applying medication appropriately (ie, a pea-sized amount of topical retinoid per application) may help limit irritation.4,5
- One type of acne seen more commonly, although not exclusively, in Black patients is pomade acne, which principally appears on the forehead and is associated with use of hair care and styling products (Figure, C).
Health disparity highlight
Disparities in access to health care exist for those with dermatologic concerns. According to one study, African American (28.5%) and Hispanic patients (23.9%) were less likely to be seen by a dermatologist solely for the diagnosis of a dermatologic condition compared to Asian and Pacific Islander patients (36.7%) or White patients (43.2%).1
Noting that isotretinoin is the most potent systemic therapy for severe cystic acne vulgaris, Bell et al6 reported that Black patients had lower odds of receiving isotretinoin compared to White patients. Hispanic patients had lower odds of receiving a topical retinoid, tretinoin, than non-Hispanic patients.6
THE COMPARISON
A A 27-year-old Hispanic woman with comedonal and inflammatory acne. Erythema is prominent around the inflammatory lesions. Note the pustule on the cheek surrounded by pink color.
B A teenaged Black boy with acne papules and pustules on the face. There are comedones, hyperpigmented macules, and pustules on the cheek.
C A teenaged Black girl with pomade acne. The patient used various hair care products, which obstructed the pilosebaceous units on the forehead.
Epidemiology
Acne is a leading dermatologic condition in individuals with skin of color in the United States.1
Key clinical features in people with darker skin tones include:
- erythematous or hyperpigmented papules or comedones
- hyperpigmented macules and postinflammatory hyperpigmentation (PIH)
- increased risk for keloidal scars.2
Worth noting
- Patients with darker skin tones may be more concerned with the dark marks (also referred to as scars or manchas in Spanish) than the acne itself. This PIH may be viewed by patients as the major problem.
- Acne medications such as azelaic acid and some retinoids (when applied appropriately) can treat both acne and PIH.3
- Irritation from topical acne medications, including retinoid dermatitis, may lead to more PIH. Using noncomedogenic moisturizers and applying medication appropriately (ie, a pea-sized amount of topical retinoid per application) may help limit irritation.4,5
- One type of acne seen more commonly, although not exclusively, in Black patients is pomade acne, which principally appears on the forehead and is associated with use of hair care and styling products (Figure, C).
Health disparity highlight
Disparities in access to health care exist for those with dermatologic concerns. According to one study, African American (28.5%) and Hispanic patients (23.9%) were less likely to be seen by a dermatologist solely for the diagnosis of a dermatologic condition compared to Asian and Pacific Islander patients (36.7%) or White patients (43.2%).1
Noting that isotretinoin is the most potent systemic therapy for severe cystic acne vulgaris, Bell et al6 reported that Black patients had lower odds of receiving isotretinoin compared to White patients. Hispanic patients had lower odds of receiving a topical retinoid, tretinoin, than non-Hispanic patients.6
- Davis SA, Narahari S, Feldman SR, et al. Top dermatologic conditions in patients of color: an analysis of nationally representative data. J Drugs Dermatol. 2012;11:466-473.
- Alexis AF, Woolery-Lloyd H, Williams K, et al. Racial/ethnic variations in acne: implications for treatment and skin care recommendations for acne patients with skin of color. J Drugs Dermatol. 2021;20:716-725.
- Woolery-Lloyd HC, Keri J, Doig S. Retinoids and azelaic acid to treat acne and hyperpigmentation in skin of color. J Drugs Dermatol. 2013;12:434-437.
- Grayson C, Heath C. Tips for addressing common conditions affecting pediatric and adolescent patients with skin of color [published online March 2, 2021]. Pediatr Dermatol. doi:10.1111/pde.14525
- Alexis AD, Harper JC, Stein Gold L, et al. Treating acne in patients with skin of color. Semin Cutan Med Surg. 2018;37(suppl 3):S71-S73.
- Bell MA, Whang KA, Thomas J, et al. Racial and ethnic disparities in access to emerging and frontline therapies in common dermatological conditions: a cross-sectional study. J Natl Med Assoc. 2020;112:650-653.
- Davis SA, Narahari S, Feldman SR, et al. Top dermatologic conditions in patients of color: an analysis of nationally representative data. J Drugs Dermatol. 2012;11:466-473.
- Alexis AF, Woolery-Lloyd H, Williams K, et al. Racial/ethnic variations in acne: implications for treatment and skin care recommendations for acne patients with skin of color. J Drugs Dermatol. 2021;20:716-725.
- Woolery-Lloyd HC, Keri J, Doig S. Retinoids and azelaic acid to treat acne and hyperpigmentation in skin of color. J Drugs Dermatol. 2013;12:434-437.
- Grayson C, Heath C. Tips for addressing common conditions affecting pediatric and adolescent patients with skin of color [published online March 2, 2021]. Pediatr Dermatol. doi:10.1111/pde.14525
- Alexis AD, Harper JC, Stein Gold L, et al. Treating acne in patients with skin of color. Semin Cutan Med Surg. 2018;37(suppl 3):S71-S73.
- Bell MA, Whang KA, Thomas J, et al. Racial and ethnic disparities in access to emerging and frontline therapies in common dermatological conditions: a cross-sectional study. J Natl Med Assoc. 2020;112:650-653.
As opioid deaths climb, human trials begin for vaccine
Opioid-related drug overdose deaths in the United States exploded to an estimated record high of 69,031 people in 2020, topping the 49,860 deaths logged in 2019, according to a new report from the Centers for Disease Control and Prevention. Most of the deaths involved synthetic opioids such as fentanyl.
President Joe Biden has pledged more than $10 billion to expand access to prevention, treatment, and recovery services. The money is important as people receiving treatment for opioid use disorder have a high risk for relapse, and that means a high risk for opioid overdose.
Now, researchers are studying a possible bridge to successful recovery: A vaccine that could blunt the drugs’ ability to cause harm.
The first such vaccines are now entering clinical trials, raising hopes of adding another tool to the antiaddiction armamentarium. But even if the vaccines prove safe and effective, their success could generate some new problems to solve.
An advantage of vaccines is that their effects can last for several months, said trial investigator Sandra Comer, PhD, professor of neurobiology and psychiatry at Columbia University Irving Medical Center, New York. Dropout rates for existing medical therapies for opioid use disorder are as high as 50% at 6 months, and a vaccine could protect people from overdose and give them time to re-enter treatment.
“It serves as a bit of a safety net,” she said.
The first vaccine to enter a trial targets oxycodone. Volunteers are being recruited who have a diagnosis of opioid use disorder but are not being medically treated and are still using opioids. A third of them will receive a placebo vaccine, a third will receive a low-dose injection of vaccine, and the other third will receive a high-dose vaccine.
A shot against oxycodone
Researchers are primarily tracking the safety of the shot, but they’re also looking at whether vaccination prevents the euphoria that opioids usually produce. They expect to enroll 24 people initially but expand to 45 if results look promising.
In response to the shot, the body produces antibodies, proteins that tag oxycodone and keep it from reaching the brain. If the drug can’t reach brain cells, it can’t produce euphoria. And more important for lifesaving effects, it can’t block the brain’s signals to the body to breathe. The vaccine has already performed well in animal studies.
Previous trials of vaccines for cocaine and nicotine failed. Those vaccines made it to the last clinical trial stage, but didn’t prove effective overall. So this time, investigators plan to track antibody levels in participants, examining blood samples for signs of a good immune response to the vaccine.
But even though earlier cocaine and nicotine vaccines didn’t work for everybody, there were some people they seemed to help. This is why investigators involved in opioid vaccine trials want to track immune responses, said Marco Pravetoni, PhD, associate professor of pharmacology and medicine at the University of Minnesota, Minneapolis, whose team will be assessing the blood samples. Ultimately, a doctor might even be able to use this information to tailor vaccine selection to a specific person.
Dr. Pravetoni also said that oxycodone is one of three vaccine targets – the other two are heroin and fentanyl – that researchers hope to combine into a single shot. Recipients might need to have one shot a month for the first 3 to 4 months and then receive annual boosters.
Stopping the pain
The vaccines also raise some issues that need attention, said Cody Wenthur, PharmD, PhD, assistant professor of pharmacy at the University of Wisconsin–Madison, who is not involved in the vaccine trials.
“If you’re vaccinated against oxycodone, you might not have access to adequate pain control if you get into a car accident, for example,” he said.
Clinicians could use other opioids for pain management, but limiting the opioids that the vaccine targets is a “double-edged sword,” said Dr. Wenthur, because vaccinated people could just switch their opioid of choice to one that a vaccine does not inhibit.
Although these issues need to be addressed, vaccines, if successful, will have an important role. Dr. Wenthur noted a survey of pharmacists and pharmacy students that he and his group conducted showing that respondents “overwhelmingly” viewed a potential vaccine as helpful.
said Dr. Pravetoni. He mentioned the 2002 incident when terrorists took over a theater in Moscow and Russian special forces are thought to have used an aerosolized form of fentanyl to incapacitate everyone in the room. More than 100 of the hostages died, and the episode raised the specter of opioids being used in chemical attacks.
Dr. Pravetoni said vaccination could offer protection for first responders, law enforcement or other people whose professions place them at risk for inhalation, either accidentally or through such attacks.
These or other real-world applications for people at risk for exposure are several years away. Dr. Pravetoni said it took 10 years to get to this phase and estimates that, in about 5 years, a vaccine that targets multiple opioid drugs might enter the first clinical trial.
A version of this article first appeared on WebMD.com.
Opioid-related drug overdose deaths in the United States exploded to an estimated record high of 69,031 people in 2020, topping the 49,860 deaths logged in 2019, according to a new report from the Centers for Disease Control and Prevention. Most of the deaths involved synthetic opioids such as fentanyl.
President Joe Biden has pledged more than $10 billion to expand access to prevention, treatment, and recovery services. The money is important as people receiving treatment for opioid use disorder have a high risk for relapse, and that means a high risk for opioid overdose.
Now, researchers are studying a possible bridge to successful recovery: A vaccine that could blunt the drugs’ ability to cause harm.
The first such vaccines are now entering clinical trials, raising hopes of adding another tool to the antiaddiction armamentarium. But even if the vaccines prove safe and effective, their success could generate some new problems to solve.
An advantage of vaccines is that their effects can last for several months, said trial investigator Sandra Comer, PhD, professor of neurobiology and psychiatry at Columbia University Irving Medical Center, New York. Dropout rates for existing medical therapies for opioid use disorder are as high as 50% at 6 months, and a vaccine could protect people from overdose and give them time to re-enter treatment.
“It serves as a bit of a safety net,” she said.
The first vaccine to enter a trial targets oxycodone. Volunteers are being recruited who have a diagnosis of opioid use disorder but are not being medically treated and are still using opioids. A third of them will receive a placebo vaccine, a third will receive a low-dose injection of vaccine, and the other third will receive a high-dose vaccine.
A shot against oxycodone
Researchers are primarily tracking the safety of the shot, but they’re also looking at whether vaccination prevents the euphoria that opioids usually produce. They expect to enroll 24 people initially but expand to 45 if results look promising.
In response to the shot, the body produces antibodies, proteins that tag oxycodone and keep it from reaching the brain. If the drug can’t reach brain cells, it can’t produce euphoria. And more important for lifesaving effects, it can’t block the brain’s signals to the body to breathe. The vaccine has already performed well in animal studies.
Previous trials of vaccines for cocaine and nicotine failed. Those vaccines made it to the last clinical trial stage, but didn’t prove effective overall. So this time, investigators plan to track antibody levels in participants, examining blood samples for signs of a good immune response to the vaccine.
But even though earlier cocaine and nicotine vaccines didn’t work for everybody, there were some people they seemed to help. This is why investigators involved in opioid vaccine trials want to track immune responses, said Marco Pravetoni, PhD, associate professor of pharmacology and medicine at the University of Minnesota, Minneapolis, whose team will be assessing the blood samples. Ultimately, a doctor might even be able to use this information to tailor vaccine selection to a specific person.
Dr. Pravetoni also said that oxycodone is one of three vaccine targets – the other two are heroin and fentanyl – that researchers hope to combine into a single shot. Recipients might need to have one shot a month for the first 3 to 4 months and then receive annual boosters.
Stopping the pain
The vaccines also raise some issues that need attention, said Cody Wenthur, PharmD, PhD, assistant professor of pharmacy at the University of Wisconsin–Madison, who is not involved in the vaccine trials.
“If you’re vaccinated against oxycodone, you might not have access to adequate pain control if you get into a car accident, for example,” he said.
Clinicians could use other opioids for pain management, but limiting the opioids that the vaccine targets is a “double-edged sword,” said Dr. Wenthur, because vaccinated people could just switch their opioid of choice to one that a vaccine does not inhibit.
Although these issues need to be addressed, vaccines, if successful, will have an important role. Dr. Wenthur noted a survey of pharmacists and pharmacy students that he and his group conducted showing that respondents “overwhelmingly” viewed a potential vaccine as helpful.
said Dr. Pravetoni. He mentioned the 2002 incident when terrorists took over a theater in Moscow and Russian special forces are thought to have used an aerosolized form of fentanyl to incapacitate everyone in the room. More than 100 of the hostages died, and the episode raised the specter of opioids being used in chemical attacks.
Dr. Pravetoni said vaccination could offer protection for first responders, law enforcement or other people whose professions place them at risk for inhalation, either accidentally or through such attacks.
These or other real-world applications for people at risk for exposure are several years away. Dr. Pravetoni said it took 10 years to get to this phase and estimates that, in about 5 years, a vaccine that targets multiple opioid drugs might enter the first clinical trial.
A version of this article first appeared on WebMD.com.
Opioid-related drug overdose deaths in the United States exploded to an estimated record high of 69,031 people in 2020, topping the 49,860 deaths logged in 2019, according to a new report from the Centers for Disease Control and Prevention. Most of the deaths involved synthetic opioids such as fentanyl.
President Joe Biden has pledged more than $10 billion to expand access to prevention, treatment, and recovery services. The money is important as people receiving treatment for opioid use disorder have a high risk for relapse, and that means a high risk for opioid overdose.
Now, researchers are studying a possible bridge to successful recovery: A vaccine that could blunt the drugs’ ability to cause harm.
The first such vaccines are now entering clinical trials, raising hopes of adding another tool to the antiaddiction armamentarium. But even if the vaccines prove safe and effective, their success could generate some new problems to solve.
An advantage of vaccines is that their effects can last for several months, said trial investigator Sandra Comer, PhD, professor of neurobiology and psychiatry at Columbia University Irving Medical Center, New York. Dropout rates for existing medical therapies for opioid use disorder are as high as 50% at 6 months, and a vaccine could protect people from overdose and give them time to re-enter treatment.
“It serves as a bit of a safety net,” she said.
The first vaccine to enter a trial targets oxycodone. Volunteers are being recruited who have a diagnosis of opioid use disorder but are not being medically treated and are still using opioids. A third of them will receive a placebo vaccine, a third will receive a low-dose injection of vaccine, and the other third will receive a high-dose vaccine.
A shot against oxycodone
Researchers are primarily tracking the safety of the shot, but they’re also looking at whether vaccination prevents the euphoria that opioids usually produce. They expect to enroll 24 people initially but expand to 45 if results look promising.
In response to the shot, the body produces antibodies, proteins that tag oxycodone and keep it from reaching the brain. If the drug can’t reach brain cells, it can’t produce euphoria. And more important for lifesaving effects, it can’t block the brain’s signals to the body to breathe. The vaccine has already performed well in animal studies.
Previous trials of vaccines for cocaine and nicotine failed. Those vaccines made it to the last clinical trial stage, but didn’t prove effective overall. So this time, investigators plan to track antibody levels in participants, examining blood samples for signs of a good immune response to the vaccine.
But even though earlier cocaine and nicotine vaccines didn’t work for everybody, there were some people they seemed to help. This is why investigators involved in opioid vaccine trials want to track immune responses, said Marco Pravetoni, PhD, associate professor of pharmacology and medicine at the University of Minnesota, Minneapolis, whose team will be assessing the blood samples. Ultimately, a doctor might even be able to use this information to tailor vaccine selection to a specific person.
Dr. Pravetoni also said that oxycodone is one of three vaccine targets – the other two are heroin and fentanyl – that researchers hope to combine into a single shot. Recipients might need to have one shot a month for the first 3 to 4 months and then receive annual boosters.
Stopping the pain
The vaccines also raise some issues that need attention, said Cody Wenthur, PharmD, PhD, assistant professor of pharmacy at the University of Wisconsin–Madison, who is not involved in the vaccine trials.
“If you’re vaccinated against oxycodone, you might not have access to adequate pain control if you get into a car accident, for example,” he said.
Clinicians could use other opioids for pain management, but limiting the opioids that the vaccine targets is a “double-edged sword,” said Dr. Wenthur, because vaccinated people could just switch their opioid of choice to one that a vaccine does not inhibit.
Although these issues need to be addressed, vaccines, if successful, will have an important role. Dr. Wenthur noted a survey of pharmacists and pharmacy students that he and his group conducted showing that respondents “overwhelmingly” viewed a potential vaccine as helpful.
said Dr. Pravetoni. He mentioned the 2002 incident when terrorists took over a theater in Moscow and Russian special forces are thought to have used an aerosolized form of fentanyl to incapacitate everyone in the room. More than 100 of the hostages died, and the episode raised the specter of opioids being used in chemical attacks.
Dr. Pravetoni said vaccination could offer protection for first responders, law enforcement or other people whose professions place them at risk for inhalation, either accidentally or through such attacks.
These or other real-world applications for people at risk for exposure are several years away. Dr. Pravetoni said it took 10 years to get to this phase and estimates that, in about 5 years, a vaccine that targets multiple opioid drugs might enter the first clinical trial.
A version of this article first appeared on WebMD.com.
