A combination of droperidol and midazolam was more effective than haloperidol plus lorazepam for achieving sedation in agitated patients in an emergency department setting in a study involving 86 adult patients at a single tertiary medical care center.

Patients with acute agitation present significant safety concerns in the emergency department, according to Jessica Javed, MD, of the University of Louisville (Ky.) and colleagues.

A combination of haloperidol and lorazepam has been widely used to curb agitation in these patients, but droperidol and midazolam could be more effective, owing to faster onset of action, Dr. Javed noted in a presentation at the annual meeting of the American College of Emergency Physicians.

Dr. Javed and colleagues conducted a prospective study to compare time to adequate sedation in agitated patients in the ED. In the trial, 43 patients received droperidol 5 mg plus midazolam 5 mg, and 43 patients received haloperidol plus lorazepam 2 mg. The average age of the patients in the droperidol/midazolam group was 34 years; the average age of the patients in the haloperidol/lorazepam group was 38 years. Baseline demographics, including height, weight, body mass index, and baseline Sedation Assessment Tool (SAT) scores, were similar between the groups.

The SAT score scale ranges from +3 (combative, violent, or out of control) to –3 (no response to stimulation); zero indicates being awake and calm/cooperative. The median baseline SAT score was 3 for both treatment groups.

The primary outcome was the proportion of patients with adequate sedation (defined as SAT scores of ≤0) 10 min after treatment.

Significantly more patients in the droperidol/midazolam group met this outcome, compared with the patients in the haloperidol/lorazepam group (51.2% vs. 7%). Also, significantly more patients in the droperidol/midazolam group achieved adequate sedation at 5, 10, 15, and 30 min than in the haloperidol/lorazepam group.

Fewer patients in the haloperidol/lorazepam group required supplemental oxygen, compared with the droperidol/midazolam group (9.3% vs. 25.6%). However, none of the droperidol/midazolam patients required rescue sedation, compared with 16.3% of the haloperidol/lorazepam patients, Dr. Javed noted. None of the patients required endotracheal intubation or experienced extrapyramidal symptoms, she said.

The study was limited by the small sample size and inclusion of data from only a single center.

The results suggest that droperidol/midazolam is superior to intramuscular haloperidol/lorazepam for producing adequate sedation after 10 min in agitated patients, Dr. Javed concluded.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.
 

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

A combination of droperidol and midazolam was more effective than haloperidol plus lorazepam for achieving sedation in agitated patients in an emergency department setting in a study involving 86 adult patients at a single tertiary medical care center.

Patients with acute agitation present significant safety concerns in the emergency department, according to Jessica Javed, MD, of the University of Louisville (Ky.) and colleagues.

A combination of haloperidol and lorazepam has been widely used to curb agitation in these patients, but droperidol and midazolam could be more effective, owing to faster onset of action, Dr. Javed noted in a presentation at the annual meeting of the American College of Emergency Physicians.

Dr. Javed and colleagues conducted a prospective study to compare time to adequate sedation in agitated patients in the ED. In the trial, 43 patients received droperidol 5 mg plus midazolam 5 mg, and 43 patients received haloperidol plus lorazepam 2 mg. The average age of the patients in the droperidol/midazolam group was 34 years; the average age of the patients in the haloperidol/lorazepam group was 38 years. Baseline demographics, including height, weight, body mass index, and baseline Sedation Assessment Tool (SAT) scores, were similar between the groups.

The SAT score scale ranges from +3 (combative, violent, or out of control) to –3 (no response to stimulation); zero indicates being awake and calm/cooperative. The median baseline SAT score was 3 for both treatment groups.

The primary outcome was the proportion of patients with adequate sedation (defined as SAT scores of ≤0) 10 min after treatment.

Significantly more patients in the droperidol/midazolam group met this outcome, compared with the patients in the haloperidol/lorazepam group (51.2% vs. 7%). Also, significantly more patients in the droperidol/midazolam group achieved adequate sedation at 5, 10, 15, and 30 min than in the haloperidol/lorazepam group.

Fewer patients in the haloperidol/lorazepam group required supplemental oxygen, compared with the droperidol/midazolam group (9.3% vs. 25.6%). However, none of the droperidol/midazolam patients required rescue sedation, compared with 16.3% of the haloperidol/lorazepam patients, Dr. Javed noted. None of the patients required endotracheal intubation or experienced extrapyramidal symptoms, she said.

The study was limited by the small sample size and inclusion of data from only a single center.

The results suggest that droperidol/midazolam is superior to intramuscular haloperidol/lorazepam for producing adequate sedation after 10 min in agitated patients, Dr. Javed concluded.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.
 

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

A combination of droperidol and midazolam was more effective than haloperidol plus lorazepam for achieving sedation in agitated patients in an emergency department setting in a study involving 86 adult patients at a single tertiary medical care center.

Patients with acute agitation present significant safety concerns in the emergency department, according to Jessica Javed, MD, of the University of Louisville (Ky.) and colleagues.

A combination of haloperidol and lorazepam has been widely used to curb agitation in these patients, but droperidol and midazolam could be more effective, owing to faster onset of action, Dr. Javed noted in a presentation at the annual meeting of the American College of Emergency Physicians.

Dr. Javed and colleagues conducted a prospective study to compare time to adequate sedation in agitated patients in the ED. In the trial, 43 patients received droperidol 5 mg plus midazolam 5 mg, and 43 patients received haloperidol plus lorazepam 2 mg. The average age of the patients in the droperidol/midazolam group was 34 years; the average age of the patients in the haloperidol/lorazepam group was 38 years. Baseline demographics, including height, weight, body mass index, and baseline Sedation Assessment Tool (SAT) scores, were similar between the groups.

The SAT score scale ranges from +3 (combative, violent, or out of control) to –3 (no response to stimulation); zero indicates being awake and calm/cooperative. The median baseline SAT score was 3 for both treatment groups.

The primary outcome was the proportion of patients with adequate sedation (defined as SAT scores of ≤0) 10 min after treatment.

Significantly more patients in the droperidol/midazolam group met this outcome, compared with the patients in the haloperidol/lorazepam group (51.2% vs. 7%). Also, significantly more patients in the droperidol/midazolam group achieved adequate sedation at 5, 10, 15, and 30 min than in the haloperidol/lorazepam group.

Fewer patients in the haloperidol/lorazepam group required supplemental oxygen, compared with the droperidol/midazolam group (9.3% vs. 25.6%). However, none of the droperidol/midazolam patients required rescue sedation, compared with 16.3% of the haloperidol/lorazepam patients, Dr. Javed noted. None of the patients required endotracheal intubation or experienced extrapyramidal symptoms, she said.

The study was limited by the small sample size and inclusion of data from only a single center.

The results suggest that droperidol/midazolam is superior to intramuscular haloperidol/lorazepam for producing adequate sedation after 10 min in agitated patients, Dr. Javed concluded.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.
 

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

With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?

Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and by May 17, over 750,000 children, or 5% of the demographic category, had received at least one dose. By Sept. 9 – 109 days later – 50% of all 15.2 million children aged 12-15 had received at least one dose of the COVID-19 vaccine, according to data from the CDC.

(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)

The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.

That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.

So where does that put the 5- to 11-year-olds?

The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”

Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.

“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.

[email protected]

With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?

Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and by May 17, over 750,000 children, or 5% of the demographic category, had received at least one dose. By Sept. 9 – 109 days later – 50% of all 15.2 million children aged 12-15 had received at least one dose of the COVID-19 vaccine, according to data from the CDC.

(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)

The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.

That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.

So where does that put the 5- to 11-year-olds?

The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”

Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.

“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.

[email protected]

With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?

Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and by May 17, over 750,000 children, or 5% of the demographic category, had received at least one dose. By Sept. 9 – 109 days later – 50% of all 15.2 million children aged 12-15 had received at least one dose of the COVID-19 vaccine, according to data from the CDC.

(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)

The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.

That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.

So where does that put the 5- to 11-year-olds?

The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”

Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.

“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.

[email protected]

During over 3 hours of oral arguments on Nov. 1, a seeming majority of Supreme Court justices appeared receptive to blocking a Texas law that essentially bans abortion after 6 weeks.

They seemed less certain about whether the federal government — which is also challenging the law — was within its rights to sue Texas.

Senate Bill 8, which went into effect September 1, allows any private citizen to file suit anywhere in the state against anyone who performs, induces, or “aids or abets” an abortion. If successful in court, the plaintiff is entitled to at least $10,000 and does not have to pay attorneys’ fees; rather, defendants are required to pay all legal costs.

In September, most justices denied an emergency request to stop the law but agreed to quickly hear the challenges in person.

At the Nov. 1 hearing, it appeared that a few justices who had let the law stand — notably conservatives Amy Coney Barrett and Brett Kavanaugh — were now agreeing that its challengers, in particular the abortion provider Whole Woman’s Health, might have a legal basis to move forward.

“I think it’s pretty likely the Court is going to do something that allows ‘someone’s’ suit against SB 8 to go ahead,” tweeted Raffi Melkonian, a Houston attorney, after the hearing. “I don’t know when they’re going to do that.”

The Supreme Court usually issues its opinions months after arguments. Since these two challenges — Whole Woman’s Health v. Jackson and US v. Texas —  were heard on a faster schedule, there’s speculation that a decision could also come quickly.

“The court clearly is in a hurry,” wrote Florida State University law professor Mary Ziegler before the hearing in a post on court-tracking site SCOTUSblog. She said the court seems to be taking the abortion issue as seriously as most Americans, and that the justices could rule before it hears oral arguments on December 1 in a Mississippi case directly challenging Roe v. Wade.

In addition, data shows abortions have been severely curtailed in Texas since the law took effect — by as much as 50% according to researchers at the University of Texas at Austin. They reported that 2,164 abortions were provided in September 2021, compared with 4,313 in September 2020.

“The actual provisions in this law have prevented every woman in Texas from exercising a constitutional right as declared by this court,” said Justice Elena Kagan, clarifying that it was every woman who had not made a decision by 6 weeks.

“Usually, in these chilling effect cases, we’re kind of guessing,” she said. “Here, we’re not guessing. We know exactly what has happened as a result of this law. It has chilled everybody on the ground.”

Judge Edward Stone II, an attorney with the Texas Attorney General’s Office who argued for the state, denied Justice Kagan’s assertion.

Nineteen medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, American Academy of Pediatrics, and the American College of Physicians, filed a friend of the court brief supporting both challenges, saying the Texas law allows legislators to interfere with the patient–doctor relationship and that it limits treatment options.

Texas argued that the only way to challenge the law at the federal level would be to be sued first.

Marc A. Hearron, a lawyer with the Center for Reproductive Rights who argued for Whole Woman’s Health, said that was untenable.

“What my friends on the other side are saying is that clinics should just violate the law,” and “subject themselves to the risk that they will be forced to close their doors,” said Mr. Hearron. 

But even if providers decide to violate the law, “they may not find physicians, nurses, ultrasound technicians, staff members willing to work behind the desk, because this law targets all of them,” he said.

Plus, clinics run the risk of becoming permanent defendants because the law does not prohibit multiple suits, he said.

Whole Woman’s Health asked the justices to stop the law by preventing the state’s clerks from filing cases.
 

Federal standing not as clear

The U.S. Department of Justice sued Texas on September 9, saying the law negated the constitutional right to an abortion.

“The Act is clearly unconstitutional under longstanding Supreme Court precedent,” Attorney General Merrick Garland said at the time.

At the court, U.S. Solicitor General Elizabeth B. Prelogar called it a “brazen attack” on the supremacy of federal law and said it would open the door to other states mounting similar challenges.

Justice Kagan seemed to agree.

“The entire point of this law, its purpose, and its effect is to find the chink in the armor of Ex parte Young,” a 1908 law that “set out a basic principle of how our government is supposed to work and how people can seek review of unconstitutional state laws,” she said, decrying that “after all these many years, some geniuses came up with a way to evade the commands of that decision.”

Judge Stone waved off the concerns. “Nothing in this law even pretends that Texas courts could evade that because it can’t,” he said.

“Essentially, we would be inviting states, all 50 of them, with respect to their unpreferred constitutional rights, to try to nullify the law — that this Court has laid down as to the content of those rights,” said Justice Kagan.

Justice Kavanaugh also seemed concerned about that possibility.

“It could be free speech rights. It could be free exercise of religion rights. It could be Second Amendment rights if this position is accepted here,” he said, citing a brief submitted by the Firearms Policy Coalition that supported the Whole Woman’s Health challenge.

Justice Neil Gorsuch seemed dubious that the Texas law would undercut anybody’s right to challenge.

“Often constitutional rights, of course, can only be enforced in a defensive posture, when an individual is faced either with potential liability, punitive damages, but also, of course, civil fines — fines and even criminal sanction, including prison time,” he said.

Judge Stone argued that the U.S. government is “not a proper plaintiff” and did not have the right to sue Texas or any of its officials because none were involved in enforcing the law. If the federal government didn’t like the law, it should ask Congress to fix it, said Judge Stone.

After the hearing, Texas Attorney General Ken Paxton reiterated that position.

“The Biden Administration does not have the power to sue a state, such as Texas, just because it disagrees with a state law that protects the unborn,” he said in a statement.

A ruling on the challenges will not put an end to the litigation over SB 8.

“Even if the Supreme Court does rule that the abortion provider plaintiffs are allowed to sue, it is likely that there will still need to be more litigation in a federal trial court before SB 8 is actually determined to be unconstitutional and is blocked by a court order,” wrote Ian Millhiser, a Supreme Court scholar, after the hearing.

A federal judge in Austin did approve the Department of Justice’s request for a temporary halt to the law in October, but days later, the Fifth Circuit Court of Appeals ruled it could go back into effect while the legal questions were being pondered in the courts.

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

During over 3 hours of oral arguments on Nov. 1, a seeming majority of Supreme Court justices appeared receptive to blocking a Texas law that essentially bans abortion after 6 weeks.

They seemed less certain about whether the federal government — which is also challenging the law — was within its rights to sue Texas.

Senate Bill 8, which went into effect September 1, allows any private citizen to file suit anywhere in the state against anyone who performs, induces, or “aids or abets” an abortion. If successful in court, the plaintiff is entitled to at least $10,000 and does not have to pay attorneys’ fees; rather, defendants are required to pay all legal costs.

In September, most justices denied an emergency request to stop the law but agreed to quickly hear the challenges in person.

At the Nov. 1 hearing, it appeared that a few justices who had let the law stand — notably conservatives Amy Coney Barrett and Brett Kavanaugh — were now agreeing that its challengers, in particular the abortion provider Whole Woman’s Health, might have a legal basis to move forward.

“I think it’s pretty likely the Court is going to do something that allows ‘someone’s’ suit against SB 8 to go ahead,” tweeted Raffi Melkonian, a Houston attorney, after the hearing. “I don’t know when they’re going to do that.”

The Supreme Court usually issues its opinions months after arguments. Since these two challenges — Whole Woman’s Health v. Jackson and US v. Texas —  were heard on a faster schedule, there’s speculation that a decision could also come quickly.

“The court clearly is in a hurry,” wrote Florida State University law professor Mary Ziegler before the hearing in a post on court-tracking site SCOTUSblog. She said the court seems to be taking the abortion issue as seriously as most Americans, and that the justices could rule before it hears oral arguments on December 1 in a Mississippi case directly challenging Roe v. Wade.

In addition, data shows abortions have been severely curtailed in Texas since the law took effect — by as much as 50% according to researchers at the University of Texas at Austin. They reported that 2,164 abortions were provided in September 2021, compared with 4,313 in September 2020.

“The actual provisions in this law have prevented every woman in Texas from exercising a constitutional right as declared by this court,” said Justice Elena Kagan, clarifying that it was every woman who had not made a decision by 6 weeks.

“Usually, in these chilling effect cases, we’re kind of guessing,” she said. “Here, we’re not guessing. We know exactly what has happened as a result of this law. It has chilled everybody on the ground.”

Judge Edward Stone II, an attorney with the Texas Attorney General’s Office who argued for the state, denied Justice Kagan’s assertion.

Nineteen medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, American Academy of Pediatrics, and the American College of Physicians, filed a friend of the court brief supporting both challenges, saying the Texas law allows legislators to interfere with the patient–doctor relationship and that it limits treatment options.

Texas argued that the only way to challenge the law at the federal level would be to be sued first.

Marc A. Hearron, a lawyer with the Center for Reproductive Rights who argued for Whole Woman’s Health, said that was untenable.

“What my friends on the other side are saying is that clinics should just violate the law,” and “subject themselves to the risk that they will be forced to close their doors,” said Mr. Hearron. 

But even if providers decide to violate the law, “they may not find physicians, nurses, ultrasound technicians, staff members willing to work behind the desk, because this law targets all of them,” he said.

Plus, clinics run the risk of becoming permanent defendants because the law does not prohibit multiple suits, he said.

Whole Woman’s Health asked the justices to stop the law by preventing the state’s clerks from filing cases.
 

Federal standing not as clear

The U.S. Department of Justice sued Texas on September 9, saying the law negated the constitutional right to an abortion.

“The Act is clearly unconstitutional under longstanding Supreme Court precedent,” Attorney General Merrick Garland said at the time.

At the court, U.S. Solicitor General Elizabeth B. Prelogar called it a “brazen attack” on the supremacy of federal law and said it would open the door to other states mounting similar challenges.

Justice Kagan seemed to agree.

“The entire point of this law, its purpose, and its effect is to find the chink in the armor of Ex parte Young,” a 1908 law that “set out a basic principle of how our government is supposed to work and how people can seek review of unconstitutional state laws,” she said, decrying that “after all these many years, some geniuses came up with a way to evade the commands of that decision.”

Judge Stone waved off the concerns. “Nothing in this law even pretends that Texas courts could evade that because it can’t,” he said.

“Essentially, we would be inviting states, all 50 of them, with respect to their unpreferred constitutional rights, to try to nullify the law — that this Court has laid down as to the content of those rights,” said Justice Kagan.

Justice Kavanaugh also seemed concerned about that possibility.

“It could be free speech rights. It could be free exercise of religion rights. It could be Second Amendment rights if this position is accepted here,” he said, citing a brief submitted by the Firearms Policy Coalition that supported the Whole Woman’s Health challenge.

Justice Neil Gorsuch seemed dubious that the Texas law would undercut anybody’s right to challenge.

“Often constitutional rights, of course, can only be enforced in a defensive posture, when an individual is faced either with potential liability, punitive damages, but also, of course, civil fines — fines and even criminal sanction, including prison time,” he said.

Judge Stone argued that the U.S. government is “not a proper plaintiff” and did not have the right to sue Texas or any of its officials because none were involved in enforcing the law. If the federal government didn’t like the law, it should ask Congress to fix it, said Judge Stone.

After the hearing, Texas Attorney General Ken Paxton reiterated that position.

“The Biden Administration does not have the power to sue a state, such as Texas, just because it disagrees with a state law that protects the unborn,” he said in a statement.

A ruling on the challenges will not put an end to the litigation over SB 8.

“Even if the Supreme Court does rule that the abortion provider plaintiffs are allowed to sue, it is likely that there will still need to be more litigation in a federal trial court before SB 8 is actually determined to be unconstitutional and is blocked by a court order,” wrote Ian Millhiser, a Supreme Court scholar, after the hearing.

A federal judge in Austin did approve the Department of Justice’s request for a temporary halt to the law in October, but days later, the Fifth Circuit Court of Appeals ruled it could go back into effect while the legal questions were being pondered in the courts.

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

During over 3 hours of oral arguments on Nov. 1, a seeming majority of Supreme Court justices appeared receptive to blocking a Texas law that essentially bans abortion after 6 weeks.

They seemed less certain about whether the federal government — which is also challenging the law — was within its rights to sue Texas.

Senate Bill 8, which went into effect September 1, allows any private citizen to file suit anywhere in the state against anyone who performs, induces, or “aids or abets” an abortion. If successful in court, the plaintiff is entitled to at least $10,000 and does not have to pay attorneys’ fees; rather, defendants are required to pay all legal costs.

In September, most justices denied an emergency request to stop the law but agreed to quickly hear the challenges in person.

At the Nov. 1 hearing, it appeared that a few justices who had let the law stand — notably conservatives Amy Coney Barrett and Brett Kavanaugh — were now agreeing that its challengers, in particular the abortion provider Whole Woman’s Health, might have a legal basis to move forward.

“I think it’s pretty likely the Court is going to do something that allows ‘someone’s’ suit against SB 8 to go ahead,” tweeted Raffi Melkonian, a Houston attorney, after the hearing. “I don’t know when they’re going to do that.”

The Supreme Court usually issues its opinions months after arguments. Since these two challenges — Whole Woman’s Health v. Jackson and US v. Texas —  were heard on a faster schedule, there’s speculation that a decision could also come quickly.

“The court clearly is in a hurry,” wrote Florida State University law professor Mary Ziegler before the hearing in a post on court-tracking site SCOTUSblog. She said the court seems to be taking the abortion issue as seriously as most Americans, and that the justices could rule before it hears oral arguments on December 1 in a Mississippi case directly challenging Roe v. Wade.

In addition, data shows abortions have been severely curtailed in Texas since the law took effect — by as much as 50% according to researchers at the University of Texas at Austin. They reported that 2,164 abortions were provided in September 2021, compared with 4,313 in September 2020.

“The actual provisions in this law have prevented every woman in Texas from exercising a constitutional right as declared by this court,” said Justice Elena Kagan, clarifying that it was every woman who had not made a decision by 6 weeks.

“Usually, in these chilling effect cases, we’re kind of guessing,” she said. “Here, we’re not guessing. We know exactly what has happened as a result of this law. It has chilled everybody on the ground.”

Judge Edward Stone II, an attorney with the Texas Attorney General’s Office who argued for the state, denied Justice Kagan’s assertion.

Nineteen medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, American Academy of Family Physicians, American Academy of Pediatrics, and the American College of Physicians, filed a friend of the court brief supporting both challenges, saying the Texas law allows legislators to interfere with the patient–doctor relationship and that it limits treatment options.

Texas argued that the only way to challenge the law at the federal level would be to be sued first.

Marc A. Hearron, a lawyer with the Center for Reproductive Rights who argued for Whole Woman’s Health, said that was untenable.

“What my friends on the other side are saying is that clinics should just violate the law,” and “subject themselves to the risk that they will be forced to close their doors,” said Mr. Hearron. 

But even if providers decide to violate the law, “they may not find physicians, nurses, ultrasound technicians, staff members willing to work behind the desk, because this law targets all of them,” he said.

Plus, clinics run the risk of becoming permanent defendants because the law does not prohibit multiple suits, he said.

Whole Woman’s Health asked the justices to stop the law by preventing the state’s clerks from filing cases.
 

Federal standing not as clear

The U.S. Department of Justice sued Texas on September 9, saying the law negated the constitutional right to an abortion.

“The Act is clearly unconstitutional under longstanding Supreme Court precedent,” Attorney General Merrick Garland said at the time.

At the court, U.S. Solicitor General Elizabeth B. Prelogar called it a “brazen attack” on the supremacy of federal law and said it would open the door to other states mounting similar challenges.

Justice Kagan seemed to agree.

“The entire point of this law, its purpose, and its effect is to find the chink in the armor of Ex parte Young,” a 1908 law that “set out a basic principle of how our government is supposed to work and how people can seek review of unconstitutional state laws,” she said, decrying that “after all these many years, some geniuses came up with a way to evade the commands of that decision.”

Judge Stone waved off the concerns. “Nothing in this law even pretends that Texas courts could evade that because it can’t,” he said.

“Essentially, we would be inviting states, all 50 of them, with respect to their unpreferred constitutional rights, to try to nullify the law — that this Court has laid down as to the content of those rights,” said Justice Kagan.

Justice Kavanaugh also seemed concerned about that possibility.

“It could be free speech rights. It could be free exercise of religion rights. It could be Second Amendment rights if this position is accepted here,” he said, citing a brief submitted by the Firearms Policy Coalition that supported the Whole Woman’s Health challenge.

Justice Neil Gorsuch seemed dubious that the Texas law would undercut anybody’s right to challenge.

“Often constitutional rights, of course, can only be enforced in a defensive posture, when an individual is faced either with potential liability, punitive damages, but also, of course, civil fines — fines and even criminal sanction, including prison time,” he said.

Judge Stone argued that the U.S. government is “not a proper plaintiff” and did not have the right to sue Texas or any of its officials because none were involved in enforcing the law. If the federal government didn’t like the law, it should ask Congress to fix it, said Judge Stone.

After the hearing, Texas Attorney General Ken Paxton reiterated that position.

“The Biden Administration does not have the power to sue a state, such as Texas, just because it disagrees with a state law that protects the unborn,” he said in a statement.

A ruling on the challenges will not put an end to the litigation over SB 8.

“Even if the Supreme Court does rule that the abortion provider plaintiffs are allowed to sue, it is likely that there will still need to be more litigation in a federal trial court before SB 8 is actually determined to be unconstitutional and is blocked by a court order,” wrote Ian Millhiser, a Supreme Court scholar, after the hearing.

A federal judge in Austin did approve the Department of Justice’s request for a temporary halt to the law in October, but days later, the Fifth Circuit Court of Appeals ruled it could go back into effect while the legal questions were being pondered in the courts.

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

It was Oct. 28 when the two big North American cardiology societies issued a joint practice guideline on evaluating and managing chest pain that was endorsed by five other subspecialty groups. The next day, another group that had taken part in the document’s genesis explained why it wasn’t one of those five.

Although the American Society of Nuclear Cardiology (ASNC) was “actively engaged at every stage of the guideline-writing and review process,” the society “could not endorse the guideline,” the society announced in a statement released to clinicians and the media. The most prominent cited reason: It doesn’t adequately “support the principle of Patient First Imaging.”

The guideline was published in Circulation and the Journal of the American College of Cardiology, flagship journals of the American Heart Association and American College of Cardiology, respectively.

The document notes at least two clinicians represented ASNC as peer reviewers, and another was on the writing committee, but the organization does not appear in the list of societies endorsing the document.

“We believe that the document fails to provide unbiased guidance to health care professionals on the optimal evaluation of patients with chest pain,” contends an editorial ASNC board members have scheduled for the Jan. 10 issue of the Journal of Nuclear Medicine but is available now on an open-access preprint server.

“Despite the many important and helpful recommendations in the new guideline, there are several recommendations that we could not support,” it states.

“The ASNC board of directors reviewed the document twice during the endorsement process,” and the society “offered substantive comments after the first endorsement review, several of which were addressed,” Randall C. Thompson, MD, St. Luke’s Mid America Heart Institute and University of Missouri–Kansas City, said in an interview.

“However, some of the board’s concerns went unresolved. It was after the board’s second review, when the document had been declared finalized, that they voted not to endorse,” said Dr. Thompson, who is ASNC president.

“When we gather multiple organizations together to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of peer-reviewed, published literature and create clinical practice recommendations,” Guideline Writing Committee Chair Martha Gulati, MD, University of Arizona, Phoenix, told this news organization in a prepared statement.

“The ASNC had a representative on the writing committee who is a coauthor on the paper and actively participated throughout the writing process the past 4 years,” she said. “The final guideline reflects the latest evidence-based recommendations for the evaluation and diagnosis of chest pain, as agreed by the seven endorsing organizations.”

The document does not clearly note that an ASNC representative was on the writing committee. However, ASNC confirmed that Renee Bullock-Palmer, MD, Deborah Heart and Lung Center, Browns Mills, N.J., is a fellow of the ASNC and had represented the group as one of the coauthors. Two “official reviewers” of the document, however, are listed as ASNC representatives.
 

Points of contention

“The decision about which test to order can be a nuanced one, and cardiac imaging tests tend to be complementary,” elaborates the editorial on the issue of patient-centered management.

Careful patient selection for different tests is important, “and physician and technical local expertise, availability, quality of equipment, and patient preference are extremely important factors to consider. There is not enough emphasis on this important point,” contend the authors. “This is an important limitation of the guideline.”

Other issues of concern include “lack of balance in the document’s presentation of the science on FFR-CT [fractional flow reserve assessment with computed tomography] and its inappropriately prominent endorsement,” the editorial states.

The U.S. Food and Drug Administration–recognized “limitations and contraindications” to FFR-CT tend to be glossed over in the document, Dr. Thompson said. And most ASNC board members were “concerned with the prominent location of the recommendations for FFR-CT in various tables – especially since there was minimal-to-no discussion of the fact that it is currently provided by only one company, that it is not widely available nor covered routinely by health insurance carriers, and [that] the accuracy in the most relevant population is disputed.”

In other concerns, the document “inadequately discusses the benefit” of combining coronary artery calcium (CAC) scores with functional testing, which ASNC said it supports. For example, adding CAC scores to myocardial perfusion imaging improves its diagnostic accuracy and prognostic power.
 

Functional vs. anatomic testing?

Moreover, “it is no longer appropriate to bundle all types of stress testing together. All stress imaging tests have their unique advantages and limitations.” Yet, “the concept of the dichotomy of functional testing versus anatomic testing is a common theme in the guideline in many important patient groups,” the editorial states. That could overemphasize CT angiography and thus “blur distinction between different types of functional tests.”

Such concerns about “imbalance” in the portrayals of the two kinds of tests were “amplified by the problem of health insurance companies and radiologic benefits managers inappropriately substituting a test that was ordered by a physician with a different test,” Dr. Thompson elaborated. “There is the impression that some of them ‘cherry-pick’ certain guidelines and that this practice is harmful to patients.”

The ASNC currently does not plan its own corresponding guideline, he said. But the editorial says that “over the coming weeks and months ASNC will offer a series of webinars and other programs that address specific patient populations and dilemmas.” Also, “we will enhance our focus on programs to address quality and efficiency to support a patient-first approach to imaging.”

The five subspecialty groups that have endorsed the document are the American Society of Echocardiography, American College of Chest Physicians, Society for Academic Emergency Medicine, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.

Dr. Thompson has reported no relevant financial relationships. Statements of disclosure for the other editorial writers are listed in the publication.

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

It was Oct. 28 when the two big North American cardiology societies issued a joint practice guideline on evaluating and managing chest pain that was endorsed by five other subspecialty groups. The next day, another group that had taken part in the document’s genesis explained why it wasn’t one of those five.

Although the American Society of Nuclear Cardiology (ASNC) was “actively engaged at every stage of the guideline-writing and review process,” the society “could not endorse the guideline,” the society announced in a statement released to clinicians and the media. The most prominent cited reason: It doesn’t adequately “support the principle of Patient First Imaging.”

The guideline was published in Circulation and the Journal of the American College of Cardiology, flagship journals of the American Heart Association and American College of Cardiology, respectively.

The document notes at least two clinicians represented ASNC as peer reviewers, and another was on the writing committee, but the organization does not appear in the list of societies endorsing the document.

“We believe that the document fails to provide unbiased guidance to health care professionals on the optimal evaluation of patients with chest pain,” contends an editorial ASNC board members have scheduled for the Jan. 10 issue of the Journal of Nuclear Medicine but is available now on an open-access preprint server.

“Despite the many important and helpful recommendations in the new guideline, there are several recommendations that we could not support,” it states.

“The ASNC board of directors reviewed the document twice during the endorsement process,” and the society “offered substantive comments after the first endorsement review, several of which were addressed,” Randall C. Thompson, MD, St. Luke’s Mid America Heart Institute and University of Missouri–Kansas City, said in an interview.

“However, some of the board’s concerns went unresolved. It was after the board’s second review, when the document had been declared finalized, that they voted not to endorse,” said Dr. Thompson, who is ASNC president.

“When we gather multiple organizations together to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of peer-reviewed, published literature and create clinical practice recommendations,” Guideline Writing Committee Chair Martha Gulati, MD, University of Arizona, Phoenix, told this news organization in a prepared statement.

“The ASNC had a representative on the writing committee who is a coauthor on the paper and actively participated throughout the writing process the past 4 years,” she said. “The final guideline reflects the latest evidence-based recommendations for the evaluation and diagnosis of chest pain, as agreed by the seven endorsing organizations.”

The document does not clearly note that an ASNC representative was on the writing committee. However, ASNC confirmed that Renee Bullock-Palmer, MD, Deborah Heart and Lung Center, Browns Mills, N.J., is a fellow of the ASNC and had represented the group as one of the coauthors. Two “official reviewers” of the document, however, are listed as ASNC representatives.
 

Points of contention

“The decision about which test to order can be a nuanced one, and cardiac imaging tests tend to be complementary,” elaborates the editorial on the issue of patient-centered management.

Careful patient selection for different tests is important, “and physician and technical local expertise, availability, quality of equipment, and patient preference are extremely important factors to consider. There is not enough emphasis on this important point,” contend the authors. “This is an important limitation of the guideline.”

Other issues of concern include “lack of balance in the document’s presentation of the science on FFR-CT [fractional flow reserve assessment with computed tomography] and its inappropriately prominent endorsement,” the editorial states.

The U.S. Food and Drug Administration–recognized “limitations and contraindications” to FFR-CT tend to be glossed over in the document, Dr. Thompson said. And most ASNC board members were “concerned with the prominent location of the recommendations for FFR-CT in various tables – especially since there was minimal-to-no discussion of the fact that it is currently provided by only one company, that it is not widely available nor covered routinely by health insurance carriers, and [that] the accuracy in the most relevant population is disputed.”

In other concerns, the document “inadequately discusses the benefit” of combining coronary artery calcium (CAC) scores with functional testing, which ASNC said it supports. For example, adding CAC scores to myocardial perfusion imaging improves its diagnostic accuracy and prognostic power.
 

Functional vs. anatomic testing?

Moreover, “it is no longer appropriate to bundle all types of stress testing together. All stress imaging tests have their unique advantages and limitations.” Yet, “the concept of the dichotomy of functional testing versus anatomic testing is a common theme in the guideline in many important patient groups,” the editorial states. That could overemphasize CT angiography and thus “blur distinction between different types of functional tests.”

Such concerns about “imbalance” in the portrayals of the two kinds of tests were “amplified by the problem of health insurance companies and radiologic benefits managers inappropriately substituting a test that was ordered by a physician with a different test,” Dr. Thompson elaborated. “There is the impression that some of them ‘cherry-pick’ certain guidelines and that this practice is harmful to patients.”

The ASNC currently does not plan its own corresponding guideline, he said. But the editorial says that “over the coming weeks and months ASNC will offer a series of webinars and other programs that address specific patient populations and dilemmas.” Also, “we will enhance our focus on programs to address quality and efficiency to support a patient-first approach to imaging.”

The five subspecialty groups that have endorsed the document are the American Society of Echocardiography, American College of Chest Physicians, Society for Academic Emergency Medicine, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.

Dr. Thompson has reported no relevant financial relationships. Statements of disclosure for the other editorial writers are listed in the publication.

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

It was Oct. 28 when the two big North American cardiology societies issued a joint practice guideline on evaluating and managing chest pain that was endorsed by five other subspecialty groups. The next day, another group that had taken part in the document’s genesis explained why it wasn’t one of those five.

Although the American Society of Nuclear Cardiology (ASNC) was “actively engaged at every stage of the guideline-writing and review process,” the society “could not endorse the guideline,” the society announced in a statement released to clinicians and the media. The most prominent cited reason: It doesn’t adequately “support the principle of Patient First Imaging.”

The guideline was published in Circulation and the Journal of the American College of Cardiology, flagship journals of the American Heart Association and American College of Cardiology, respectively.

The document notes at least two clinicians represented ASNC as peer reviewers, and another was on the writing committee, but the organization does not appear in the list of societies endorsing the document.

“We believe that the document fails to provide unbiased guidance to health care professionals on the optimal evaluation of patients with chest pain,” contends an editorial ASNC board members have scheduled for the Jan. 10 issue of the Journal of Nuclear Medicine but is available now on an open-access preprint server.

“Despite the many important and helpful recommendations in the new guideline, there are several recommendations that we could not support,” it states.

“The ASNC board of directors reviewed the document twice during the endorsement process,” and the society “offered substantive comments after the first endorsement review, several of which were addressed,” Randall C. Thompson, MD, St. Luke’s Mid America Heart Institute and University of Missouri–Kansas City, said in an interview.

“However, some of the board’s concerns went unresolved. It was after the board’s second review, when the document had been declared finalized, that they voted not to endorse,” said Dr. Thompson, who is ASNC president.

“When we gather multiple organizations together to review and summarize the evidence, we work collaboratively to interpret the extensive catalog of peer-reviewed, published literature and create clinical practice recommendations,” Guideline Writing Committee Chair Martha Gulati, MD, University of Arizona, Phoenix, told this news organization in a prepared statement.

“The ASNC had a representative on the writing committee who is a coauthor on the paper and actively participated throughout the writing process the past 4 years,” she said. “The final guideline reflects the latest evidence-based recommendations for the evaluation and diagnosis of chest pain, as agreed by the seven endorsing organizations.”

The document does not clearly note that an ASNC representative was on the writing committee. However, ASNC confirmed that Renee Bullock-Palmer, MD, Deborah Heart and Lung Center, Browns Mills, N.J., is a fellow of the ASNC and had represented the group as one of the coauthors. Two “official reviewers” of the document, however, are listed as ASNC representatives.
 

Points of contention

“The decision about which test to order can be a nuanced one, and cardiac imaging tests tend to be complementary,” elaborates the editorial on the issue of patient-centered management.

Careful patient selection for different tests is important, “and physician and technical local expertise, availability, quality of equipment, and patient preference are extremely important factors to consider. There is not enough emphasis on this important point,” contend the authors. “This is an important limitation of the guideline.”

Other issues of concern include “lack of balance in the document’s presentation of the science on FFR-CT [fractional flow reserve assessment with computed tomography] and its inappropriately prominent endorsement,” the editorial states.

The U.S. Food and Drug Administration–recognized “limitations and contraindications” to FFR-CT tend to be glossed over in the document, Dr. Thompson said. And most ASNC board members were “concerned with the prominent location of the recommendations for FFR-CT in various tables – especially since there was minimal-to-no discussion of the fact that it is currently provided by only one company, that it is not widely available nor covered routinely by health insurance carriers, and [that] the accuracy in the most relevant population is disputed.”

In other concerns, the document “inadequately discusses the benefit” of combining coronary artery calcium (CAC) scores with functional testing, which ASNC said it supports. For example, adding CAC scores to myocardial perfusion imaging improves its diagnostic accuracy and prognostic power.
 

Functional vs. anatomic testing?

Moreover, “it is no longer appropriate to bundle all types of stress testing together. All stress imaging tests have their unique advantages and limitations.” Yet, “the concept of the dichotomy of functional testing versus anatomic testing is a common theme in the guideline in many important patient groups,” the editorial states. That could overemphasize CT angiography and thus “blur distinction between different types of functional tests.”

Such concerns about “imbalance” in the portrayals of the two kinds of tests were “amplified by the problem of health insurance companies and radiologic benefits managers inappropriately substituting a test that was ordered by a physician with a different test,” Dr. Thompson elaborated. “There is the impression that some of them ‘cherry-pick’ certain guidelines and that this practice is harmful to patients.”

The ASNC currently does not plan its own corresponding guideline, he said. But the editorial says that “over the coming weeks and months ASNC will offer a series of webinars and other programs that address specific patient populations and dilemmas.” Also, “we will enhance our focus on programs to address quality and efficiency to support a patient-first approach to imaging.”

The five subspecialty groups that have endorsed the document are the American Society of Echocardiography, American College of Chest Physicians, Society for Academic Emergency Medicine, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance.

Dr. Thompson has reported no relevant financial relationships. Statements of disclosure for the other editorial writers are listed in the publication.

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

Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.

“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.

“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”

Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.

The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.

Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.

Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.

Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.

Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.

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

Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.

“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.

“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”

Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.

The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.

Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.

Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.

Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.

Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.

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

Unvaccinated people who had a recent infection were five times more likely to be reinfected with the coronavirus compared to those who were fully vaccinated and didn’t have a prior infection, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.

The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.

“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.

“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”

Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.

The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.

Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.

Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.

Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.

Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.

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

Oral drug administration was significantly associated with a shorter length of stay for patients treated for headache in the emergency department setting, based on data from approximately 7,000 patients.

Headache is the fourth-most common chief complaint in the ED, accounting for approximately 3% of all ED visits, said Philip Wang, a medical student at the Cleveland Clinic, in a presentation at the annual meeting of the American College of Emergency Physicians.

A variety of pharmacotherapies are used to manage headache, which leads to a range of resource use, he said.

To understand the association between route of drug administration and length of ED stay, Mr. Wang and colleagues reviewed data from 7,233 visits by 6,715 patients at any of the 21 Cleveland Clinic Health System EDs in 2018 with headache as the primary discharge diagnosis. Patients admitted to the hospital were excluded; those treated with opioids, antiemetics, and/or NSAIDs were included. The average age of the study population was 31 years, 57% were White, and approximately half were Medicaid or Medicare patients.

Approximately 68% of patients received antiemetics, 66.8% received NSAIDs, and 9.8% received opioids. Approximately 42% of patients received parenteral-only treatment and 42% received oral-only treatment; 15% received mixed treatment. The average length of ED stay was 202 minutes.

In a multivariate analysis adjusted for sex, age, income, race, insurance status, ED type, and arrival time, treatment with oral drugs only was associated with an 11% reduction of length of stay, compared with treatment with parenteral medication only (P < .001). However, the length of stay for patients treated with mixed route of administration was 10% longer, compared with parenteral only (P < .001).

In terms of drug class (a secondary outcome), patients treated with opioids had a 10% increase in length of stay (P < .01) and those treated with antiemetics had a 14% increase in length of stay; however, patients treated with NSAIDs had a 7% decrease in length of stay.

The study findings were limited in part by the challenge of isolating patients presenting with a primary headache diagnosis, Mr. Wang noted in the presentation.

The challenge of controlling for all the potential factors impacting length of stay, which is “provider, resource, and situation dependent,” is an additional limitation, he said.

However, the results show that route of administration has a significant impact on length of ED stay in patients presenting with headache, he concluded.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

Oral drug administration was significantly associated with a shorter length of stay for patients treated for headache in the emergency department setting, based on data from approximately 7,000 patients.

Headache is the fourth-most common chief complaint in the ED, accounting for approximately 3% of all ED visits, said Philip Wang, a medical student at the Cleveland Clinic, in a presentation at the annual meeting of the American College of Emergency Physicians.

A variety of pharmacotherapies are used to manage headache, which leads to a range of resource use, he said.

To understand the association between route of drug administration and length of ED stay, Mr. Wang and colleagues reviewed data from 7,233 visits by 6,715 patients at any of the 21 Cleveland Clinic Health System EDs in 2018 with headache as the primary discharge diagnosis. Patients admitted to the hospital were excluded; those treated with opioids, antiemetics, and/or NSAIDs were included. The average age of the study population was 31 years, 57% were White, and approximately half were Medicaid or Medicare patients.

Approximately 68% of patients received antiemetics, 66.8% received NSAIDs, and 9.8% received opioids. Approximately 42% of patients received parenteral-only treatment and 42% received oral-only treatment; 15% received mixed treatment. The average length of ED stay was 202 minutes.

In a multivariate analysis adjusted for sex, age, income, race, insurance status, ED type, and arrival time, treatment with oral drugs only was associated with an 11% reduction of length of stay, compared with treatment with parenteral medication only (P < .001). However, the length of stay for patients treated with mixed route of administration was 10% longer, compared with parenteral only (P < .001).

In terms of drug class (a secondary outcome), patients treated with opioids had a 10% increase in length of stay (P < .01) and those treated with antiemetics had a 14% increase in length of stay; however, patients treated with NSAIDs had a 7% decrease in length of stay.

The study findings were limited in part by the challenge of isolating patients presenting with a primary headache diagnosis, Mr. Wang noted in the presentation.

The challenge of controlling for all the potential factors impacting length of stay, which is “provider, resource, and situation dependent,” is an additional limitation, he said.

However, the results show that route of administration has a significant impact on length of ED stay in patients presenting with headache, he concluded.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

Oral drug administration was significantly associated with a shorter length of stay for patients treated for headache in the emergency department setting, based on data from approximately 7,000 patients.

Headache is the fourth-most common chief complaint in the ED, accounting for approximately 3% of all ED visits, said Philip Wang, a medical student at the Cleveland Clinic, in a presentation at the annual meeting of the American College of Emergency Physicians.

A variety of pharmacotherapies are used to manage headache, which leads to a range of resource use, he said.

To understand the association between route of drug administration and length of ED stay, Mr. Wang and colleagues reviewed data from 7,233 visits by 6,715 patients at any of the 21 Cleveland Clinic Health System EDs in 2018 with headache as the primary discharge diagnosis. Patients admitted to the hospital were excluded; those treated with opioids, antiemetics, and/or NSAIDs were included. The average age of the study population was 31 years, 57% were White, and approximately half were Medicaid or Medicare patients.

Approximately 68% of patients received antiemetics, 66.8% received NSAIDs, and 9.8% received opioids. Approximately 42% of patients received parenteral-only treatment and 42% received oral-only treatment; 15% received mixed treatment. The average length of ED stay was 202 minutes.

In a multivariate analysis adjusted for sex, age, income, race, insurance status, ED type, and arrival time, treatment with oral drugs only was associated with an 11% reduction of length of stay, compared with treatment with parenteral medication only (P < .001). However, the length of stay for patients treated with mixed route of administration was 10% longer, compared with parenteral only (P < .001).

In terms of drug class (a secondary outcome), patients treated with opioids had a 10% increase in length of stay (P < .01) and those treated with antiemetics had a 14% increase in length of stay; however, patients treated with NSAIDs had a 7% decrease in length of stay.

The study findings were limited in part by the challenge of isolating patients presenting with a primary headache diagnosis, Mr. Wang noted in the presentation.

The challenge of controlling for all the potential factors impacting length of stay, which is “provider, resource, and situation dependent,” is an additional limitation, he said.

However, the results show that route of administration has a significant impact on length of ED stay in patients presenting with headache, he concluded.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

Patients with rheumatoid arthritis who are treated with methotrexate (MTX) are more than twice as likely to develop venous thromboembolism (VTE) when compared with patients who use hydroxychloroquine, according to data from a propensity score–matched cohort study.

“As the effect of these medications on the risk of VTE is largely unknown, we aimed to compare the rate of incident VTE after initiating MTX versus hydroxychloroquine among older patients with RA,” wrote Mengdong He, MHS, and coauthors from Brigham and Women’s Hospital and Harvard Medical School, both in Boston. Ms. At the time of the study, Ms. He was a research specialist but is now a medical student at the University of California, Los Angeles.

The results were published in Seminars in Arthritis and Rheumatism.

Using U.S. Medicare claims data from 2008 to 2017, the researchers identified patients with RA aged 65 years and older who initiated MTX or hydroxychloroquine without prior use of any immunomodulators for at least 365 days (that is, index date). Patients who used any conventional (other than methotrexate and hydroxychloroquine), biologic, or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) any time prior to the index date were excluded.

The primary outcome of interest was incident VTE, a composite endpoint of pulmonary embolism (PE) or deep vein thrombosis (DVT). Secondary outcomes were PE, DVT, and all-cause mortality.

Results

After applying the eligibility criteria, a total of 68,648 RA patients who initiated either MTX (n = 41,197) or hydroxychloroquine (n = 27,451) as their first DMARD were identified and included in the analysis.

After 1:1 propensity score matching, the cohort consisted of 26,534 matched pairs of MTX and hydroxychloroquine initiators. The mean age was 74 years (standard deviation, 7 years), and 79% of the patients were female.

During a total of 56,686 person-years of follow-up, VTE occurred in 208 MTX (incidence, 6.94 per 1,000 person-years) and 83 hydroxychloroquine initiators (incidence, 3.11 per 1,000 person-years).

Patients who initiated MTX without prior use of any DMARDs had a higher risk of PE (hazard ratio, 3.30; 95% confidence interval, 2.28-4.77) and DVT (HR, 1.53; 95% CI, 1.07-2.19) than hydroxychloroquine initiators. However, all-cause mortality did not differ between the two groups (HR, 0.91; 95% CI, 0.83-1.00).

“MTX initiators had a relative risk of VTE higher than 2 and an absolute risk increase of about 4 per 1,000 person-years, compared with hydroxychloroquine initiators,” the authors wrote. “Results from the secondary outcome analyses were consistent and subgroup analyses found no meaningful treatment effect heterogeneity.”

The researchers acknowledged that a key limitation of the study was the use of claims-based algorithms to define outcomes. As a result, outcome misclassification is possible.

“While the study methodology was sound, patients with RA who receive hydroxychloroquine are very different than those who receive MTX, and it’s difficult to fully account for these differences using an administrative data set,” commented Kaleb Michaud, PhD, professor of internal medicine at the University of Nebraska, Omaha.

“Most clinicians are more interested in understanding the differences in VTE risk between MTX and Jakinibs [Janus kinase inhibitors] or MTX and biologics,” Dr. Michaud said.

“More research, particularly with randomized trials including the placebo arm, is needed to determine the causal relationships between the study drugs and VTE and whether MTX elevates or hydroxychloroquine reduces the risk of VTE,” the authors concluded.

The study was funded by internal resources in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School. Several authors reported financial relationships with the pharmaceutical industry.

Patients with rheumatoid arthritis who are treated with methotrexate (MTX) are more than twice as likely to develop venous thromboembolism (VTE) when compared with patients who use hydroxychloroquine, according to data from a propensity score–matched cohort study.

“As the effect of these medications on the risk of VTE is largely unknown, we aimed to compare the rate of incident VTE after initiating MTX versus hydroxychloroquine among older patients with RA,” wrote Mengdong He, MHS, and coauthors from Brigham and Women’s Hospital and Harvard Medical School, both in Boston. Ms. At the time of the study, Ms. He was a research specialist but is now a medical student at the University of California, Los Angeles.

The results were published in Seminars in Arthritis and Rheumatism.

Using U.S. Medicare claims data from 2008 to 2017, the researchers identified patients with RA aged 65 years and older who initiated MTX or hydroxychloroquine without prior use of any immunomodulators for at least 365 days (that is, index date). Patients who used any conventional (other than methotrexate and hydroxychloroquine), biologic, or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) any time prior to the index date were excluded.

The primary outcome of interest was incident VTE, a composite endpoint of pulmonary embolism (PE) or deep vein thrombosis (DVT). Secondary outcomes were PE, DVT, and all-cause mortality.

Results

After applying the eligibility criteria, a total of 68,648 RA patients who initiated either MTX (n = 41,197) or hydroxychloroquine (n = 27,451) as their first DMARD were identified and included in the analysis.

After 1:1 propensity score matching, the cohort consisted of 26,534 matched pairs of MTX and hydroxychloroquine initiators. The mean age was 74 years (standard deviation, 7 years), and 79% of the patients were female.

During a total of 56,686 person-years of follow-up, VTE occurred in 208 MTX (incidence, 6.94 per 1,000 person-years) and 83 hydroxychloroquine initiators (incidence, 3.11 per 1,000 person-years).

Patients who initiated MTX without prior use of any DMARDs had a higher risk of PE (hazard ratio, 3.30; 95% confidence interval, 2.28-4.77) and DVT (HR, 1.53; 95% CI, 1.07-2.19) than hydroxychloroquine initiators. However, all-cause mortality did not differ between the two groups (HR, 0.91; 95% CI, 0.83-1.00).

“MTX initiators had a relative risk of VTE higher than 2 and an absolute risk increase of about 4 per 1,000 person-years, compared with hydroxychloroquine initiators,” the authors wrote. “Results from the secondary outcome analyses were consistent and subgroup analyses found no meaningful treatment effect heterogeneity.”

The researchers acknowledged that a key limitation of the study was the use of claims-based algorithms to define outcomes. As a result, outcome misclassification is possible.

“While the study methodology was sound, patients with RA who receive hydroxychloroquine are very different than those who receive MTX, and it’s difficult to fully account for these differences using an administrative data set,” commented Kaleb Michaud, PhD, professor of internal medicine at the University of Nebraska, Omaha.

“Most clinicians are more interested in understanding the differences in VTE risk between MTX and Jakinibs [Janus kinase inhibitors] or MTX and biologics,” Dr. Michaud said.

“More research, particularly with randomized trials including the placebo arm, is needed to determine the causal relationships between the study drugs and VTE and whether MTX elevates or hydroxychloroquine reduces the risk of VTE,” the authors concluded.

The study was funded by internal resources in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School. Several authors reported financial relationships with the pharmaceutical industry.

Patients with rheumatoid arthritis who are treated with methotrexate (MTX) are more than twice as likely to develop venous thromboembolism (VTE) when compared with patients who use hydroxychloroquine, according to data from a propensity score–matched cohort study.

“As the effect of these medications on the risk of VTE is largely unknown, we aimed to compare the rate of incident VTE after initiating MTX versus hydroxychloroquine among older patients with RA,” wrote Mengdong He, MHS, and coauthors from Brigham and Women’s Hospital and Harvard Medical School, both in Boston. Ms. At the time of the study, Ms. He was a research specialist but is now a medical student at the University of California, Los Angeles.

The results were published in Seminars in Arthritis and Rheumatism.

Using U.S. Medicare claims data from 2008 to 2017, the researchers identified patients with RA aged 65 years and older who initiated MTX or hydroxychloroquine without prior use of any immunomodulators for at least 365 days (that is, index date). Patients who used any conventional (other than methotrexate and hydroxychloroquine), biologic, or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) any time prior to the index date were excluded.

The primary outcome of interest was incident VTE, a composite endpoint of pulmonary embolism (PE) or deep vein thrombosis (DVT). Secondary outcomes were PE, DVT, and all-cause mortality.

Results

After applying the eligibility criteria, a total of 68,648 RA patients who initiated either MTX (n = 41,197) or hydroxychloroquine (n = 27,451) as their first DMARD were identified and included in the analysis.

After 1:1 propensity score matching, the cohort consisted of 26,534 matched pairs of MTX and hydroxychloroquine initiators. The mean age was 74 years (standard deviation, 7 years), and 79% of the patients were female.

During a total of 56,686 person-years of follow-up, VTE occurred in 208 MTX (incidence, 6.94 per 1,000 person-years) and 83 hydroxychloroquine initiators (incidence, 3.11 per 1,000 person-years).

Patients who initiated MTX without prior use of any DMARDs had a higher risk of PE (hazard ratio, 3.30; 95% confidence interval, 2.28-4.77) and DVT (HR, 1.53; 95% CI, 1.07-2.19) than hydroxychloroquine initiators. However, all-cause mortality did not differ between the two groups (HR, 0.91; 95% CI, 0.83-1.00).

“MTX initiators had a relative risk of VTE higher than 2 and an absolute risk increase of about 4 per 1,000 person-years, compared with hydroxychloroquine initiators,” the authors wrote. “Results from the secondary outcome analyses were consistent and subgroup analyses found no meaningful treatment effect heterogeneity.”

The researchers acknowledged that a key limitation of the study was the use of claims-based algorithms to define outcomes. As a result, outcome misclassification is possible.

“While the study methodology was sound, patients with RA who receive hydroxychloroquine are very different than those who receive MTX, and it’s difficult to fully account for these differences using an administrative data set,” commented Kaleb Michaud, PhD, professor of internal medicine at the University of Nebraska, Omaha.

“Most clinicians are more interested in understanding the differences in VTE risk between MTX and Jakinibs [Janus kinase inhibitors] or MTX and biologics,” Dr. Michaud said.

“More research, particularly with randomized trials including the placebo arm, is needed to determine the causal relationships between the study drugs and VTE and whether MTX elevates or hydroxychloroquine reduces the risk of VTE,” the authors concluded.

The study was funded by internal resources in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School. Several authors reported financial relationships with the pharmaceutical industry.