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IBD in pregnancy: Ustekinumab, vedolizumab use appears safe
Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.
The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.
“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”
In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.
The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.
About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.
Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.
Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.
Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.
Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.
Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.
On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.
Additional studies are needed because of the overall small study population, the researchers suggested.
“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.
“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”
No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.
This article was updated July 18, 2022.
Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.
The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.
“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”
In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.
The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.
About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.
Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.
Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.
Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.
Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.
Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.
On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.
Additional studies are needed because of the overall small study population, the researchers suggested.
“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.
“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”
No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.
This article was updated July 18, 2022.
Use of new biologics such as ustekinumab and vedolizumab during pregnancy appears to be safe, with favorable pregnancy and postnatal infant outcomes, according to a study published in the Journal of Crohn’s and Colitis.
The results, which come from the Czech IBD Working Group, point to the need for safe options to treat inflammatory bowel disease (IBD) during pregnancy, wrote the researchers led by Katarina Mitrova, MD, PhD, of the Clinical and Research Centre for Inflammatory Bowel Disease at Charles University, Prague.
“As the long-term therapy can affect pregnancy and neonatal outcomes, strong evidence is needed to reassure patients about safety,” they wrote. “Recent years have seen significant progress in research around anti-TNF treatment in pregnancy, confirming its safe use, but the data on the new biologics are still limited.”
In a prospective, multicenter observational study of women with IBD, the researchers included 54 pregnancies in 49 women exposed to ustekinumab and 39 pregnancies in 37 women exposed to vedolizumab 2 months prior to conception or during pregnancy between January 2017 and December 2021 in 15 centers across the Czech Republic.
The control group of 90 pregnancies in 81 women was collected retrospectively and included pregnant women with IBD exposed to anti–tumor necrosis factor (TNF) therapy – 29% to adalimumab and 71% to infliximab – in two centers in the Czech Republic between 2013 and 2021. Only singleton pregnancies were included in the analyses because of the increased risk of complications in multiple pregnancies, the investigators noted.
About 94% of patients treated with ustekinumab had Crohn’s disease, while the disease distribution was nearly equal in patients treated with vedolizumab. Active disease any time during pregnancy was reported in 17% of women on ustekinumab and 23% of those on vedolizumab, as well as 10% of those on anti-TNF therapy.
Pregnancies resulted in live births in 79.9% of the ustekinumab group, 89.7% of the vedolizumab group, and 87.8% of the anti-TNF group; however, these differences were not statistically significant.
Overall, there were no significant differences in pregnancy outcomes between either the vedolizumab or ustekinumab groups or the controls. Similarly, there were no negative safety signals in the postnatal outcomes of children up to 1 year of life, including measures such as growth, psychomotor development, and the risk of allergy, atopy, or infectious complications.
Ustekinumab was administered for the last time during pregnancy at median gestational week 33, ranging from 18 to 38 weeks. Five women stopped the treatment during the second trimester, and 37 continued to use it during the third trimester. An intensified regimen, shortening the interval to 4-6 weeks, was given to 13 patients. There were no disease flares after stopping the treatment.
Vedolizumab was administered for the last time during pregnancy at median gestational week 32, ranging from 18 to 38 weeks. Seven women discontinued the treatment during the second trimester, and 27 continued to use it in the third trimester. An intensified regimen was used in six pregnancies. No disease relapse was observed after treatment discontinuation.
Of the pregnancies that resulted in live births, maternal pregnancy-related complications occurred in six women (14%) treated with ustekinumab and seven women (20%) treated with vedolizumab. The most frequent complication was gestational diabetes mellitus, followed by arterial hypertension, preeclampsia, and intrapartum hemorrhage. The rate of complications was not significantly different from the control population for either biologic.
On the day of delivery, maternal venous blood and umbilical cord blood were collected to determine the levels of ustekinumab and vedolizumab.
Additional studies are needed because of the overall small study population, the researchers suggested.
“According to recent guidelines, continuing with biologic therapy, including new biologics, is recommended throughout pregnancy to prevent disease relapse, which is a strong risk factor of adverse pregnancy outcomes,” the researchers wrote.
“Data on the safety of non-anti-TNF biologics in pregnancy are limited by small numbers and, in many cases, retrospective design,” said Eugenia Shmidt, MD, an assistant professor in the division of gastroenterology, hepatology, and nutrition at the University of Minnesota and founder of the university's IBD Preconception and Pregnancy Planning Clinic. “This study’s prospective nature and larger size make it a particularly valuable contribution to the field. Hopefully IBD clinicians will be reassured that ustekinumab and vedolizumab are safe for both mother and baby and can be continued throughout the entire duration of pregnancy.”
No specific funding was received for the study. The authors listed financial disclosures and conflict of interest statements for AbbVie, Takeda, Janssen, Pfizer, Biogen, Tillotts, Ferring, Alfasigma, Celltrion, and PRO.MED.CS. Dr. Shmidt declared no relevant disclosures.
This article was updated July 18, 2022.
FROM THE JOURNAL OF CROHN’S AND COLITIS
Feds warn pharmacists: Don’t refuse to provide abortion pills
The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.
“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”
On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.
Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.
The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.
Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.
Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.
Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”
“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.
“It doesn’t sound like [pharmacies] are blocking this for men,” she said.
The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.
In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.
The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.
“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.
“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.
A version of this article first appeared on WebMD.com.
The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.
“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”
On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.
Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.
The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.
Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.
Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.
Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”
“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.
“It doesn’t sound like [pharmacies] are blocking this for men,” she said.
The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.
In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.
The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.
“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.
“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.
A version of this article first appeared on WebMD.com.
The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.
“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”
On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.
Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.
The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.
Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.
Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.
Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”
“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.
“It doesn’t sound like [pharmacies] are blocking this for men,” she said.
The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.
In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.
The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.
“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.
“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.
A version of this article first appeared on WebMD.com.
Justice Department task force to fight abortion ban overreach
Department officials announced July 12 that the task force formalizes an existing work group and recent efforts to protect access to reproductive health care considering the Supreme Court’s decision to overturn Roe v. Wade.
The task force will monitor state and local legislation and consider legal action against states that ban abortion medication, out-of-state travel for an abortion, and other measures that try to prevent reproductive health services that are authorized by federal law.
“The Supreme Court’s Dobbs decision is a devastating blow to reproductive freedom in the United States,” Associate Attorney General Vanita Gupta, the task force chair, said in a statement.
“The Court abandoned 50 years of precedent and took away the constitutional right to abortion, preventing women all over the country from being able to make critical decisions about our bodies, our health, and our futures,” she said. “The Justice Department is committed to protecting access to reproductive services.”
The task force includes representatives from the Justice Department’s Civil Division, Civil Rights Division, U.S. attorneys’ offices, Office of the Solicitor General, Office for Access to Justice, Office of Legal Counsel, Office of Legal Policy, Office of Legislative Affairs, Office of the Associate Attorney General, Office of the Deputy Attorney General, and Office of the Attorney General.
The task force is charged with coordinating federal government responses, including proactive and defensive legal action, the department said. Task force members will work with agencies across the federal government to support their work on issues related to reproductive rights and access to reproductive health care.
The Justice Department will also continue to work with external groups, such as reproductive services providers, advocates, and state attorneys general offices. It will also work with the Office of Counsel to the President to hold a meeting with private pro bono attorneys, bar associations, and public interest groups to encourage lawyers to represent patients, providers, and others in reproductive health services cases.
“Recognizing that the best way to protect reproductive freedom is through congressional action, the task force will also coordinate providing technical assistance to Congress in connection with federal legislation to codify reproductive rights and ensure access to comprehensive reproductive services,” the department wrote. “It will also coordinate the provision of technical assistance concerning federal constitutional protections to states seeking to afford legal protection to out-of-state patients and providers who offer legal reproductive health care.”
The announcement comes as some activists and lawmakers have expressed frustration about the White House’s response to changes in abortion law in recent weeks, according to The Washington Post. They’ve called on the Biden administration to do more in the wake of the Supreme Court ruling.
On July 8, President Joe Biden signed an executive order to direct his administration to pursue a variety of measures aimed at protecting abortion access, reproductive health care services, and patient privacy.
On July 11, the Department of Health & Human Services issued guidance to remind hospitals of their duty to comply with the Emergency Medical Treatment and Labor Act (EMTALA), which stands “irrespective of any state laws or mandates that apply to specific procedures.” The law requires health care personnel to provide medical screening and stabilizing treatment to patients in emergency medical situations. In the case of pregnancy, emergencies may include ectopic pregnancy, complications of pregnancy loss, or severe hypertensive disorders. Doctors must terminate a pregnancy if it’s necessary to stabilize the patient.
“When a state law prohibits abortion and does not include an exception for the life and health of the pregnant person – or draws the exception more narrowly than EMTALA’s emergency medical condition definition – that state law is preempted,” the department wrote.
Since the Supreme Court’s ruling to overturn Roe, more than a dozen states have moved to ban or severely restrict abortions, according to a state tracker by The Washington Post. Some of the laws have been temporarily blocked by courts in Kentucky, Louisiana, and Utah.
At the same time, some Republican-led states have moved to ban other reproductive health care services, such as abortion medication and telehealth visits, the newspaper reported. The Food and Drug Administration approved mifepristone in 2000, saying the pill is safe and effective for use during the first 10 weeks of pregnancy.
The Justice Department task force said it will monitor legislation that seeks to ban mifepristone, as well as block people’s ability to inform each other about reproductive care available across the country.
“We’re seeing the intimidation already in states that are making people afraid to share information about legal abortion services in other states,” Nancy Northup, president and chief executive of the Center for Reproductive Rights, told the newspaper.
The center served as the legal counsel for the Jackson Women’s Health Organization in the case that overturned Roe. Ms. Northup said the group is already involved in more than three dozen lawsuits and has filed several more since the Supreme Court’s ruling.
“It is a really frightening time,” she said.
A version of this article first appeared on WebMD.com.
Department officials announced July 12 that the task force formalizes an existing work group and recent efforts to protect access to reproductive health care considering the Supreme Court’s decision to overturn Roe v. Wade.
The task force will monitor state and local legislation and consider legal action against states that ban abortion medication, out-of-state travel for an abortion, and other measures that try to prevent reproductive health services that are authorized by federal law.
“The Supreme Court’s Dobbs decision is a devastating blow to reproductive freedom in the United States,” Associate Attorney General Vanita Gupta, the task force chair, said in a statement.
“The Court abandoned 50 years of precedent and took away the constitutional right to abortion, preventing women all over the country from being able to make critical decisions about our bodies, our health, and our futures,” she said. “The Justice Department is committed to protecting access to reproductive services.”
The task force includes representatives from the Justice Department’s Civil Division, Civil Rights Division, U.S. attorneys’ offices, Office of the Solicitor General, Office for Access to Justice, Office of Legal Counsel, Office of Legal Policy, Office of Legislative Affairs, Office of the Associate Attorney General, Office of the Deputy Attorney General, and Office of the Attorney General.
The task force is charged with coordinating federal government responses, including proactive and defensive legal action, the department said. Task force members will work with agencies across the federal government to support their work on issues related to reproductive rights and access to reproductive health care.
The Justice Department will also continue to work with external groups, such as reproductive services providers, advocates, and state attorneys general offices. It will also work with the Office of Counsel to the President to hold a meeting with private pro bono attorneys, bar associations, and public interest groups to encourage lawyers to represent patients, providers, and others in reproductive health services cases.
“Recognizing that the best way to protect reproductive freedom is through congressional action, the task force will also coordinate providing technical assistance to Congress in connection with federal legislation to codify reproductive rights and ensure access to comprehensive reproductive services,” the department wrote. “It will also coordinate the provision of technical assistance concerning federal constitutional protections to states seeking to afford legal protection to out-of-state patients and providers who offer legal reproductive health care.”
The announcement comes as some activists and lawmakers have expressed frustration about the White House’s response to changes in abortion law in recent weeks, according to The Washington Post. They’ve called on the Biden administration to do more in the wake of the Supreme Court ruling.
On July 8, President Joe Biden signed an executive order to direct his administration to pursue a variety of measures aimed at protecting abortion access, reproductive health care services, and patient privacy.
On July 11, the Department of Health & Human Services issued guidance to remind hospitals of their duty to comply with the Emergency Medical Treatment and Labor Act (EMTALA), which stands “irrespective of any state laws or mandates that apply to specific procedures.” The law requires health care personnel to provide medical screening and stabilizing treatment to patients in emergency medical situations. In the case of pregnancy, emergencies may include ectopic pregnancy, complications of pregnancy loss, or severe hypertensive disorders. Doctors must terminate a pregnancy if it’s necessary to stabilize the patient.
“When a state law prohibits abortion and does not include an exception for the life and health of the pregnant person – or draws the exception more narrowly than EMTALA’s emergency medical condition definition – that state law is preempted,” the department wrote.
Since the Supreme Court’s ruling to overturn Roe, more than a dozen states have moved to ban or severely restrict abortions, according to a state tracker by The Washington Post. Some of the laws have been temporarily blocked by courts in Kentucky, Louisiana, and Utah.
At the same time, some Republican-led states have moved to ban other reproductive health care services, such as abortion medication and telehealth visits, the newspaper reported. The Food and Drug Administration approved mifepristone in 2000, saying the pill is safe and effective for use during the first 10 weeks of pregnancy.
The Justice Department task force said it will monitor legislation that seeks to ban mifepristone, as well as block people’s ability to inform each other about reproductive care available across the country.
“We’re seeing the intimidation already in states that are making people afraid to share information about legal abortion services in other states,” Nancy Northup, president and chief executive of the Center for Reproductive Rights, told the newspaper.
The center served as the legal counsel for the Jackson Women’s Health Organization in the case that overturned Roe. Ms. Northup said the group is already involved in more than three dozen lawsuits and has filed several more since the Supreme Court’s ruling.
“It is a really frightening time,” she said.
A version of this article first appeared on WebMD.com.
Department officials announced July 12 that the task force formalizes an existing work group and recent efforts to protect access to reproductive health care considering the Supreme Court’s decision to overturn Roe v. Wade.
The task force will monitor state and local legislation and consider legal action against states that ban abortion medication, out-of-state travel for an abortion, and other measures that try to prevent reproductive health services that are authorized by federal law.
“The Supreme Court’s Dobbs decision is a devastating blow to reproductive freedom in the United States,” Associate Attorney General Vanita Gupta, the task force chair, said in a statement.
“The Court abandoned 50 years of precedent and took away the constitutional right to abortion, preventing women all over the country from being able to make critical decisions about our bodies, our health, and our futures,” she said. “The Justice Department is committed to protecting access to reproductive services.”
The task force includes representatives from the Justice Department’s Civil Division, Civil Rights Division, U.S. attorneys’ offices, Office of the Solicitor General, Office for Access to Justice, Office of Legal Counsel, Office of Legal Policy, Office of Legislative Affairs, Office of the Associate Attorney General, Office of the Deputy Attorney General, and Office of the Attorney General.
The task force is charged with coordinating federal government responses, including proactive and defensive legal action, the department said. Task force members will work with agencies across the federal government to support their work on issues related to reproductive rights and access to reproductive health care.
The Justice Department will also continue to work with external groups, such as reproductive services providers, advocates, and state attorneys general offices. It will also work with the Office of Counsel to the President to hold a meeting with private pro bono attorneys, bar associations, and public interest groups to encourage lawyers to represent patients, providers, and others in reproductive health services cases.
“Recognizing that the best way to protect reproductive freedom is through congressional action, the task force will also coordinate providing technical assistance to Congress in connection with federal legislation to codify reproductive rights and ensure access to comprehensive reproductive services,” the department wrote. “It will also coordinate the provision of technical assistance concerning federal constitutional protections to states seeking to afford legal protection to out-of-state patients and providers who offer legal reproductive health care.”
The announcement comes as some activists and lawmakers have expressed frustration about the White House’s response to changes in abortion law in recent weeks, according to The Washington Post. They’ve called on the Biden administration to do more in the wake of the Supreme Court ruling.
On July 8, President Joe Biden signed an executive order to direct his administration to pursue a variety of measures aimed at protecting abortion access, reproductive health care services, and patient privacy.
On July 11, the Department of Health & Human Services issued guidance to remind hospitals of their duty to comply with the Emergency Medical Treatment and Labor Act (EMTALA), which stands “irrespective of any state laws or mandates that apply to specific procedures.” The law requires health care personnel to provide medical screening and stabilizing treatment to patients in emergency medical situations. In the case of pregnancy, emergencies may include ectopic pregnancy, complications of pregnancy loss, or severe hypertensive disorders. Doctors must terminate a pregnancy if it’s necessary to stabilize the patient.
“When a state law prohibits abortion and does not include an exception for the life and health of the pregnant person – or draws the exception more narrowly than EMTALA’s emergency medical condition definition – that state law is preempted,” the department wrote.
Since the Supreme Court’s ruling to overturn Roe, more than a dozen states have moved to ban or severely restrict abortions, according to a state tracker by The Washington Post. Some of the laws have been temporarily blocked by courts in Kentucky, Louisiana, and Utah.
At the same time, some Republican-led states have moved to ban other reproductive health care services, such as abortion medication and telehealth visits, the newspaper reported. The Food and Drug Administration approved mifepristone in 2000, saying the pill is safe and effective for use during the first 10 weeks of pregnancy.
The Justice Department task force said it will monitor legislation that seeks to ban mifepristone, as well as block people’s ability to inform each other about reproductive care available across the country.
“We’re seeing the intimidation already in states that are making people afraid to share information about legal abortion services in other states,” Nancy Northup, president and chief executive of the Center for Reproductive Rights, told the newspaper.
The center served as the legal counsel for the Jackson Women’s Health Organization in the case that overturned Roe. Ms. Northup said the group is already involved in more than three dozen lawsuits and has filed several more since the Supreme Court’s ruling.
“It is a really frightening time,” she said.
A version of this article first appeared on WebMD.com.
Aggression toward health care providers common during pandemic
After an aggressive event or abuse occurred, 56% of providers considered changing their care tasks, and more than a third considered quitting their profession.
“Aggression of any sort against health care providers is not a new social phenomenon, and it has existed as far as medicine and health care is reported in literature. However, the phenomenon of aggression against health care providers during the pandemic grew worse,” senior study author Adrian Baranchuk, MD, a professor of medicine at Queen’s University, Kingston, Ont., told this news organization.
The study was published online in Current Problems in Cardiology
Survey snapshot
Dr. Baranchuk and colleagues, with the support of the Inter-American Society of Cardiology, developed a survey to characterize the frequency and types of abuse that frontline health professionals faced. They invited health care professionals from Latin America who had provided care since March 2020 to participate.
Between January and February 2022, 3,544 participants from 19 countries took the survey. Among them, 70.8% were physicians, 16% were nurses, and 13.2% were other health team members, such as administrative staff and technicians. About 58.5% were women, and 74.7% provided direct care to patients with COVID-19.
Overall, 54.8% of respondents reported acts of aggression. Of this group, 95.6% reported verbal abuse, 11.1% reported physical abuse, and 19.9% reported other types of abuse, including microaggressions.
About 13% of respondents reported experiencing some form of aggression daily, 26.4% experienced abuse weekly, and 38.8% reported violence a few times per month. Typically, the incidents involved patients’ relatives or both the patients and their relatives.
Nearly half of those who reported abuse experienced psychosomatic symptoms after the event, and 12% sought psychological care.
Administrative staff were 3.5 times more likely to experience abuse than other health care workers. Doctors and nurses were about twice as likely to experience abuse.
In addition, women, younger staff, and those who worked directly with COVID-19 patients were more likely to report abuse.
‘Shocking results’
Dr. Baranchuk, a native of Argentina, said people initially celebrated doctors and nurses for keeping communities safe. In several countries across Latin America, for instance, people lit candles, applauded at certain hours, and posted support on social media. As pandemic-related policies changed, however, health care providers faced unrest as people grew tired of wearing masks, maintaining social distance, and obeying restrictions at public spaces such as clubs and restaurants.
“This fatigue toward the social changes grew, but people didn’t have a specific target, and slowly and gradually, health care providers became the target of frustration and hate,” said Dr. Baranchuk. “In areas of the world where legislation is more flexible and less strict in charging individuals with poor or unacceptable behavior toward members of the health care team, aggression and microaggression became more frequent.”
“The results we obtained were more shocking than we expected,” Sebastián García-Zamora, MD, the lead study author and head of the coronary care unit at the Delta Clinic, Buenos Aires, said in an interview.
Dr. García-Zamora, also the coordinator of the International Society of Electrocardiology Young Community, noted the particularly high numbers of reports among young health care workers and women.
“Unfortunately, young women seem to be the most vulnerable staff to suffering violence, regardless of the work they perform in the health system,” he said. “Notably, less than one in four health team members that suffered workplace violence pursued legal action based on the events.”
The research team is now conducting additional analyses on the different types of aggression based on gender, region, and task performed by the health care team. They’re trying to understand who is most vulnerable to physical attacks, as well as the consequences.
“The most important thing to highlight is that this problem exists, it is more frequent than we think, and we can only solve it if we all get involved in it,” Dr. García-Zamora said.
‘Complete systematic failure’
Health care workers in certain communities faced more aggression as well. In a CMAJ Open study published in November 2021, Asian Canadian and Asian American health care workers experienced discrimination, racial microaggressions, threats of violence, and violent acts during the pandemic. Women and frontline workers with direct patient contact were more likely to face verbal and physical abuse.
“This highlights that we need to continue the fight against misogyny, racism, and health care worker discrimination,” lead study author Zhida Shang, a medical student at McGill University, Montreal, told this news organization.
“As we are managing to live with the COVID-19 pandemic, it is important to study our successes and shortcomings. I sincerely believe that during the pandemic, the treatment of various racialized communities, including Asian Americans and Asian Canadians, was a complete systematic failure,” he said. “It is crucial to continue to examine, reflect, and learn from these lessons so that there will be equitable outcomes during the next public health emergency.”
The study was conducted without funding support. Dr. Baranchuk, Dr. García-Zamora, and Ms. Shang report no relevant disclosures.
A version of this article first appeared on Medscape.com.
After an aggressive event or abuse occurred, 56% of providers considered changing their care tasks, and more than a third considered quitting their profession.
“Aggression of any sort against health care providers is not a new social phenomenon, and it has existed as far as medicine and health care is reported in literature. However, the phenomenon of aggression against health care providers during the pandemic grew worse,” senior study author Adrian Baranchuk, MD, a professor of medicine at Queen’s University, Kingston, Ont., told this news organization.
The study was published online in Current Problems in Cardiology
Survey snapshot
Dr. Baranchuk and colleagues, with the support of the Inter-American Society of Cardiology, developed a survey to characterize the frequency and types of abuse that frontline health professionals faced. They invited health care professionals from Latin America who had provided care since March 2020 to participate.
Between January and February 2022, 3,544 participants from 19 countries took the survey. Among them, 70.8% were physicians, 16% were nurses, and 13.2% were other health team members, such as administrative staff and technicians. About 58.5% were women, and 74.7% provided direct care to patients with COVID-19.
Overall, 54.8% of respondents reported acts of aggression. Of this group, 95.6% reported verbal abuse, 11.1% reported physical abuse, and 19.9% reported other types of abuse, including microaggressions.
About 13% of respondents reported experiencing some form of aggression daily, 26.4% experienced abuse weekly, and 38.8% reported violence a few times per month. Typically, the incidents involved patients’ relatives or both the patients and their relatives.
Nearly half of those who reported abuse experienced psychosomatic symptoms after the event, and 12% sought psychological care.
Administrative staff were 3.5 times more likely to experience abuse than other health care workers. Doctors and nurses were about twice as likely to experience abuse.
In addition, women, younger staff, and those who worked directly with COVID-19 patients were more likely to report abuse.
‘Shocking results’
Dr. Baranchuk, a native of Argentina, said people initially celebrated doctors and nurses for keeping communities safe. In several countries across Latin America, for instance, people lit candles, applauded at certain hours, and posted support on social media. As pandemic-related policies changed, however, health care providers faced unrest as people grew tired of wearing masks, maintaining social distance, and obeying restrictions at public spaces such as clubs and restaurants.
“This fatigue toward the social changes grew, but people didn’t have a specific target, and slowly and gradually, health care providers became the target of frustration and hate,” said Dr. Baranchuk. “In areas of the world where legislation is more flexible and less strict in charging individuals with poor or unacceptable behavior toward members of the health care team, aggression and microaggression became more frequent.”
“The results we obtained were more shocking than we expected,” Sebastián García-Zamora, MD, the lead study author and head of the coronary care unit at the Delta Clinic, Buenos Aires, said in an interview.
Dr. García-Zamora, also the coordinator of the International Society of Electrocardiology Young Community, noted the particularly high numbers of reports among young health care workers and women.
“Unfortunately, young women seem to be the most vulnerable staff to suffering violence, regardless of the work they perform in the health system,” he said. “Notably, less than one in four health team members that suffered workplace violence pursued legal action based on the events.”
The research team is now conducting additional analyses on the different types of aggression based on gender, region, and task performed by the health care team. They’re trying to understand who is most vulnerable to physical attacks, as well as the consequences.
“The most important thing to highlight is that this problem exists, it is more frequent than we think, and we can only solve it if we all get involved in it,” Dr. García-Zamora said.
‘Complete systematic failure’
Health care workers in certain communities faced more aggression as well. In a CMAJ Open study published in November 2021, Asian Canadian and Asian American health care workers experienced discrimination, racial microaggressions, threats of violence, and violent acts during the pandemic. Women and frontline workers with direct patient contact were more likely to face verbal and physical abuse.
“This highlights that we need to continue the fight against misogyny, racism, and health care worker discrimination,” lead study author Zhida Shang, a medical student at McGill University, Montreal, told this news organization.
“As we are managing to live with the COVID-19 pandemic, it is important to study our successes and shortcomings. I sincerely believe that during the pandemic, the treatment of various racialized communities, including Asian Americans and Asian Canadians, was a complete systematic failure,” he said. “It is crucial to continue to examine, reflect, and learn from these lessons so that there will be equitable outcomes during the next public health emergency.”
The study was conducted without funding support. Dr. Baranchuk, Dr. García-Zamora, and Ms. Shang report no relevant disclosures.
A version of this article first appeared on Medscape.com.
After an aggressive event or abuse occurred, 56% of providers considered changing their care tasks, and more than a third considered quitting their profession.
“Aggression of any sort against health care providers is not a new social phenomenon, and it has existed as far as medicine and health care is reported in literature. However, the phenomenon of aggression against health care providers during the pandemic grew worse,” senior study author Adrian Baranchuk, MD, a professor of medicine at Queen’s University, Kingston, Ont., told this news organization.
The study was published online in Current Problems in Cardiology
Survey snapshot
Dr. Baranchuk and colleagues, with the support of the Inter-American Society of Cardiology, developed a survey to characterize the frequency and types of abuse that frontline health professionals faced. They invited health care professionals from Latin America who had provided care since March 2020 to participate.
Between January and February 2022, 3,544 participants from 19 countries took the survey. Among them, 70.8% were physicians, 16% were nurses, and 13.2% were other health team members, such as administrative staff and technicians. About 58.5% were women, and 74.7% provided direct care to patients with COVID-19.
Overall, 54.8% of respondents reported acts of aggression. Of this group, 95.6% reported verbal abuse, 11.1% reported physical abuse, and 19.9% reported other types of abuse, including microaggressions.
About 13% of respondents reported experiencing some form of aggression daily, 26.4% experienced abuse weekly, and 38.8% reported violence a few times per month. Typically, the incidents involved patients’ relatives or both the patients and their relatives.
Nearly half of those who reported abuse experienced psychosomatic symptoms after the event, and 12% sought psychological care.
Administrative staff were 3.5 times more likely to experience abuse than other health care workers. Doctors and nurses were about twice as likely to experience abuse.
In addition, women, younger staff, and those who worked directly with COVID-19 patients were more likely to report abuse.
‘Shocking results’
Dr. Baranchuk, a native of Argentina, said people initially celebrated doctors and nurses for keeping communities safe. In several countries across Latin America, for instance, people lit candles, applauded at certain hours, and posted support on social media. As pandemic-related policies changed, however, health care providers faced unrest as people grew tired of wearing masks, maintaining social distance, and obeying restrictions at public spaces such as clubs and restaurants.
“This fatigue toward the social changes grew, but people didn’t have a specific target, and slowly and gradually, health care providers became the target of frustration and hate,” said Dr. Baranchuk. “In areas of the world where legislation is more flexible and less strict in charging individuals with poor or unacceptable behavior toward members of the health care team, aggression and microaggression became more frequent.”
“The results we obtained were more shocking than we expected,” Sebastián García-Zamora, MD, the lead study author and head of the coronary care unit at the Delta Clinic, Buenos Aires, said in an interview.
Dr. García-Zamora, also the coordinator of the International Society of Electrocardiology Young Community, noted the particularly high numbers of reports among young health care workers and women.
“Unfortunately, young women seem to be the most vulnerable staff to suffering violence, regardless of the work they perform in the health system,” he said. “Notably, less than one in four health team members that suffered workplace violence pursued legal action based on the events.”
The research team is now conducting additional analyses on the different types of aggression based on gender, region, and task performed by the health care team. They’re trying to understand who is most vulnerable to physical attacks, as well as the consequences.
“The most important thing to highlight is that this problem exists, it is more frequent than we think, and we can only solve it if we all get involved in it,” Dr. García-Zamora said.
‘Complete systematic failure’
Health care workers in certain communities faced more aggression as well. In a CMAJ Open study published in November 2021, Asian Canadian and Asian American health care workers experienced discrimination, racial microaggressions, threats of violence, and violent acts during the pandemic. Women and frontline workers with direct patient contact were more likely to face verbal and physical abuse.
“This highlights that we need to continue the fight against misogyny, racism, and health care worker discrimination,” lead study author Zhida Shang, a medical student at McGill University, Montreal, told this news organization.
“As we are managing to live with the COVID-19 pandemic, it is important to study our successes and shortcomings. I sincerely believe that during the pandemic, the treatment of various racialized communities, including Asian Americans and Asian Canadians, was a complete systematic failure,” he said. “It is crucial to continue to examine, reflect, and learn from these lessons so that there will be equitable outcomes during the next public health emergency.”
The study was conducted without funding support. Dr. Baranchuk, Dr. García-Zamora, and Ms. Shang report no relevant disclosures.
A version of this article first appeared on Medscape.com.
U.S. allows pharmacists to prescribe Paxlovid directly
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.
Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.
Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”
“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.
But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”
“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.
After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.
Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.
If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.
In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.
Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.
Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.
A version of this article first appeared on WebMD.com.
WHO tracking new Omicron subvariant in India
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.
“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.
The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.
“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.
The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.
Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.
BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.
Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.
The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.
BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.
“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.
“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.
Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.
A version of this article first appeared on WebMD.com.
Nevada sees increase in out-of-state abortion patients
Nevada is already seeing more out-of-state patients seeking an abortion, which state officials expected after the Supreme Court overturned Roe v. Wade.
Las Vegas has seen a 200% increase in patients traveling from Texas, compared with the same time last year, according to the Las Vegas Review-Journal.
Patients are also expected from Arizona, Idaho, Oklahoma, and Utah after the ruling. Abortion providers are preparing for a ripple effect as abortion bans begin across the country.
“We haven’t seen the peak yet,” Kristina Tocce, MD, medical director for Planned Parenthood of the Rocky Mountains and an obstetrician-gynecologist in Colorado, told the newspaper.
“I don’t think we’re going to see any decrease anytime in the near future,” she said.
Nevada made the right to abortion part of state law more than 3 decades ago, in 1990, which protects abortions up to 24 weeks. Colorado passed a similar law this year.
In June, before Roe was overturned, Dr. Tocce said the organization expected abortions to rise by 80% – or about 10,000 patients – in the Rocky Mountain region, which includes southern Nevada, Colorado, and New Mexico.
Even before the ruling took place, Planned Parenthood saw higher numbers of patients as abortion bans took effect in Texas and Oklahoma, she said. After the 6-week ban took place in Texas, about 45% of traveling patients went to Oklahoma. Now that a ban is in place in Oklahoma, patients are going elsewhere.
Las Vegas providers have asked patients why they decided to travel to southern Nevada for services rather than Colorado or New Mexico, which are closer to Texas, Dr. Tocce said. Patients cited several reasons, including direct flight paths, cheaper plane tickets, and the presence of family or friends who could support them.
“We’re going to see such a demand on abortion in any state that has secure access,” Dr. Tocce said. “Patients may be forced to travel further away.”
After Roe was overturned, Nevada Gov. Steve Sisolak held an emergency news conference to reaffirm the state’s commitment to protecting abortion rights. He also said he wasn’t sure about Nevada’s capacity to support out-of-state patients but providers were researching and preparing.
Two Planned Parenthood centers in southern Nevada are adding staff and increasing their hours, Dr. Tocce told the newspaper last month, though there weren’t immediate plans to increase the number of locations or add centers near state borders.
Last week, Governor Sisolak signed an executive order that stops Nevada agencies from helping other states investigate patients seeking an abortion in Nevada. The order also protects patients from extradition and health care providers from losing their license for providing abortion services.
As abortion bans continue to roll out across the U.S., patients will likely consider traveling to states that have certain protections and accessible appointments, Dr. Tocce said.
“We’re in such an ambiguous time right now, we just don’t know what each state is going to attempt to enact,” she said. “My head just swims with all of the possibilities. If that’s challenging for me, I can’t even imagine what it’s going to be like for a patient to navigate.”
A version of this article first appeared on WebMD.com.
Nevada is already seeing more out-of-state patients seeking an abortion, which state officials expected after the Supreme Court overturned Roe v. Wade.
Las Vegas has seen a 200% increase in patients traveling from Texas, compared with the same time last year, according to the Las Vegas Review-Journal.
Patients are also expected from Arizona, Idaho, Oklahoma, and Utah after the ruling. Abortion providers are preparing for a ripple effect as abortion bans begin across the country.
“We haven’t seen the peak yet,” Kristina Tocce, MD, medical director for Planned Parenthood of the Rocky Mountains and an obstetrician-gynecologist in Colorado, told the newspaper.
“I don’t think we’re going to see any decrease anytime in the near future,” she said.
Nevada made the right to abortion part of state law more than 3 decades ago, in 1990, which protects abortions up to 24 weeks. Colorado passed a similar law this year.
In June, before Roe was overturned, Dr. Tocce said the organization expected abortions to rise by 80% – or about 10,000 patients – in the Rocky Mountain region, which includes southern Nevada, Colorado, and New Mexico.
Even before the ruling took place, Planned Parenthood saw higher numbers of patients as abortion bans took effect in Texas and Oklahoma, she said. After the 6-week ban took place in Texas, about 45% of traveling patients went to Oklahoma. Now that a ban is in place in Oklahoma, patients are going elsewhere.
Las Vegas providers have asked patients why they decided to travel to southern Nevada for services rather than Colorado or New Mexico, which are closer to Texas, Dr. Tocce said. Patients cited several reasons, including direct flight paths, cheaper plane tickets, and the presence of family or friends who could support them.
“We’re going to see such a demand on abortion in any state that has secure access,” Dr. Tocce said. “Patients may be forced to travel further away.”
After Roe was overturned, Nevada Gov. Steve Sisolak held an emergency news conference to reaffirm the state’s commitment to protecting abortion rights. He also said he wasn’t sure about Nevada’s capacity to support out-of-state patients but providers were researching and preparing.
Two Planned Parenthood centers in southern Nevada are adding staff and increasing their hours, Dr. Tocce told the newspaper last month, though there weren’t immediate plans to increase the number of locations or add centers near state borders.
Last week, Governor Sisolak signed an executive order that stops Nevada agencies from helping other states investigate patients seeking an abortion in Nevada. The order also protects patients from extradition and health care providers from losing their license for providing abortion services.
As abortion bans continue to roll out across the U.S., patients will likely consider traveling to states that have certain protections and accessible appointments, Dr. Tocce said.
“We’re in such an ambiguous time right now, we just don’t know what each state is going to attempt to enact,” she said. “My head just swims with all of the possibilities. If that’s challenging for me, I can’t even imagine what it’s going to be like for a patient to navigate.”
A version of this article first appeared on WebMD.com.
Nevada is already seeing more out-of-state patients seeking an abortion, which state officials expected after the Supreme Court overturned Roe v. Wade.
Las Vegas has seen a 200% increase in patients traveling from Texas, compared with the same time last year, according to the Las Vegas Review-Journal.
Patients are also expected from Arizona, Idaho, Oklahoma, and Utah after the ruling. Abortion providers are preparing for a ripple effect as abortion bans begin across the country.
“We haven’t seen the peak yet,” Kristina Tocce, MD, medical director for Planned Parenthood of the Rocky Mountains and an obstetrician-gynecologist in Colorado, told the newspaper.
“I don’t think we’re going to see any decrease anytime in the near future,” she said.
Nevada made the right to abortion part of state law more than 3 decades ago, in 1990, which protects abortions up to 24 weeks. Colorado passed a similar law this year.
In June, before Roe was overturned, Dr. Tocce said the organization expected abortions to rise by 80% – or about 10,000 patients – in the Rocky Mountain region, which includes southern Nevada, Colorado, and New Mexico.
Even before the ruling took place, Planned Parenthood saw higher numbers of patients as abortion bans took effect in Texas and Oklahoma, she said. After the 6-week ban took place in Texas, about 45% of traveling patients went to Oklahoma. Now that a ban is in place in Oklahoma, patients are going elsewhere.
Las Vegas providers have asked patients why they decided to travel to southern Nevada for services rather than Colorado or New Mexico, which are closer to Texas, Dr. Tocce said. Patients cited several reasons, including direct flight paths, cheaper plane tickets, and the presence of family or friends who could support them.
“We’re going to see such a demand on abortion in any state that has secure access,” Dr. Tocce said. “Patients may be forced to travel further away.”
After Roe was overturned, Nevada Gov. Steve Sisolak held an emergency news conference to reaffirm the state’s commitment to protecting abortion rights. He also said he wasn’t sure about Nevada’s capacity to support out-of-state patients but providers were researching and preparing.
Two Planned Parenthood centers in southern Nevada are adding staff and increasing their hours, Dr. Tocce told the newspaper last month, though there weren’t immediate plans to increase the number of locations or add centers near state borders.
Last week, Governor Sisolak signed an executive order that stops Nevada agencies from helping other states investigate patients seeking an abortion in Nevada. The order also protects patients from extradition and health care providers from losing their license for providing abortion services.
As abortion bans continue to roll out across the U.S., patients will likely consider traveling to states that have certain protections and accessible appointments, Dr. Tocce said.
“We’re in such an ambiguous time right now, we just don’t know what each state is going to attempt to enact,” she said. “My head just swims with all of the possibilities. If that’s challenging for me, I can’t even imagine what it’s going to be like for a patient to navigate.”
A version of this article first appeared on WebMD.com.
Abortion opponents don’t want patients crossing state lines
Several national antiabortion advocacy groups and lawmakers in Republican-led states are pushing forward with plans to block people from crossing state lines to seek the procedure elsewhere.
Since the Supreme Court overturned Roe v. Wade last week, several states have enacted "trigger ban" laws to stop abortion, particularly across the Southeast and Midwest. As part of that, antiabortion groups are building momentum around the idea of blocking out-of-state travel as well, even discussing it at two national antiabortion conferences last weekend, according to The Washington Post.
"Just because you jump across a state line doesn't mean your home state doesn't have jurisdiction," Peter Breen, vice president and senior counsel for the Thomas More Society, told the newspaper.
"It's not a free abortion card when you drive across the state line," he said.
The Thomas More Society, a conservative legal organization, is drafting model legislation for state lawmakers to use, which would allow private citizens to sue anyone who helps a resident end a pregnancy outside of a state that has banned abortion. The draft language borrows from the recent Texas abortion ban, which allows private citizens to enforce the law through civil litigation.
The National Association of Christian Lawmakers, an antiabortion organization led by Republican state legislators, has also begun working with the authors of the Texas abortion ban, the Post reported. The group is exploring model legislation that would restrict people from crossing state lines for abortions.
Relying on private citizens to enforce civil litigation, rather than imposing a state-enforced ban on crossing state lines, could make these laws more difficult to challenge in court.
What's more, the legislation could have a chilling effect on doctors, who may stop performing abortions on people from other states while waiting on courts to intervene and overturn the laws, the newspaper reported.
Not every antiabortion group is supporting the idea. Catherine Glenn Foster, president of Americans United for Life, said that people access medical procedures across state lines often.
"I don't think you can prevent that," she said.
But some states may still propose these types of bills this year. Legislators in Arkansas and South Dakota, for instance, have already planned special sessions to discuss abortion legislation, which could include the issue. Lawmakers in Missouri have also supported the idea.
In contrast, several Democrat-led states have passed legislation this year to counteract laws that may try to restrict movement across state lines, according to the Post. Connecticut passed a law that offers protection from out-of-state subpoenas issued in cases related to abortion procedures that are legal in the state, and California passed a similar law to protect abortion providers and patients from civil suits.
The Justice Department has warned that it will fight laws that block people from crossing state lines, saying they violate the right to interstate commerce.
"The Constitution continues to restrict states' authority to ban reproductive services provided outside their borders," Attorney General Merrick Garland said in a statement after last week's ruling.
"We recognize that traveling to obtain reproductive care may not be feasible in many circumstances," he said. "But under bedrock constitutional principles, women who reside in states that have banned access to comprehensive reproductive care must remain free to seek that care in states where it is legal."
A version of this article first appeared on WebMD.com.
Several national antiabortion advocacy groups and lawmakers in Republican-led states are pushing forward with plans to block people from crossing state lines to seek the procedure elsewhere.
Since the Supreme Court overturned Roe v. Wade last week, several states have enacted "trigger ban" laws to stop abortion, particularly across the Southeast and Midwest. As part of that, antiabortion groups are building momentum around the idea of blocking out-of-state travel as well, even discussing it at two national antiabortion conferences last weekend, according to The Washington Post.
"Just because you jump across a state line doesn't mean your home state doesn't have jurisdiction," Peter Breen, vice president and senior counsel for the Thomas More Society, told the newspaper.
"It's not a free abortion card when you drive across the state line," he said.
The Thomas More Society, a conservative legal organization, is drafting model legislation for state lawmakers to use, which would allow private citizens to sue anyone who helps a resident end a pregnancy outside of a state that has banned abortion. The draft language borrows from the recent Texas abortion ban, which allows private citizens to enforce the law through civil litigation.
The National Association of Christian Lawmakers, an antiabortion organization led by Republican state legislators, has also begun working with the authors of the Texas abortion ban, the Post reported. The group is exploring model legislation that would restrict people from crossing state lines for abortions.
Relying on private citizens to enforce civil litigation, rather than imposing a state-enforced ban on crossing state lines, could make these laws more difficult to challenge in court.
What's more, the legislation could have a chilling effect on doctors, who may stop performing abortions on people from other states while waiting on courts to intervene and overturn the laws, the newspaper reported.
Not every antiabortion group is supporting the idea. Catherine Glenn Foster, president of Americans United for Life, said that people access medical procedures across state lines often.
"I don't think you can prevent that," she said.
But some states may still propose these types of bills this year. Legislators in Arkansas and South Dakota, for instance, have already planned special sessions to discuss abortion legislation, which could include the issue. Lawmakers in Missouri have also supported the idea.
In contrast, several Democrat-led states have passed legislation this year to counteract laws that may try to restrict movement across state lines, according to the Post. Connecticut passed a law that offers protection from out-of-state subpoenas issued in cases related to abortion procedures that are legal in the state, and California passed a similar law to protect abortion providers and patients from civil suits.
The Justice Department has warned that it will fight laws that block people from crossing state lines, saying they violate the right to interstate commerce.
"The Constitution continues to restrict states' authority to ban reproductive services provided outside their borders," Attorney General Merrick Garland said in a statement after last week's ruling.
"We recognize that traveling to obtain reproductive care may not be feasible in many circumstances," he said. "But under bedrock constitutional principles, women who reside in states that have banned access to comprehensive reproductive care must remain free to seek that care in states where it is legal."
A version of this article first appeared on WebMD.com.
Several national antiabortion advocacy groups and lawmakers in Republican-led states are pushing forward with plans to block people from crossing state lines to seek the procedure elsewhere.
Since the Supreme Court overturned Roe v. Wade last week, several states have enacted "trigger ban" laws to stop abortion, particularly across the Southeast and Midwest. As part of that, antiabortion groups are building momentum around the idea of blocking out-of-state travel as well, even discussing it at two national antiabortion conferences last weekend, according to The Washington Post.
"Just because you jump across a state line doesn't mean your home state doesn't have jurisdiction," Peter Breen, vice president and senior counsel for the Thomas More Society, told the newspaper.
"It's not a free abortion card when you drive across the state line," he said.
The Thomas More Society, a conservative legal organization, is drafting model legislation for state lawmakers to use, which would allow private citizens to sue anyone who helps a resident end a pregnancy outside of a state that has banned abortion. The draft language borrows from the recent Texas abortion ban, which allows private citizens to enforce the law through civil litigation.
The National Association of Christian Lawmakers, an antiabortion organization led by Republican state legislators, has also begun working with the authors of the Texas abortion ban, the Post reported. The group is exploring model legislation that would restrict people from crossing state lines for abortions.
Relying on private citizens to enforce civil litigation, rather than imposing a state-enforced ban on crossing state lines, could make these laws more difficult to challenge in court.
What's more, the legislation could have a chilling effect on doctors, who may stop performing abortions on people from other states while waiting on courts to intervene and overturn the laws, the newspaper reported.
Not every antiabortion group is supporting the idea. Catherine Glenn Foster, president of Americans United for Life, said that people access medical procedures across state lines often.
"I don't think you can prevent that," she said.
But some states may still propose these types of bills this year. Legislators in Arkansas and South Dakota, for instance, have already planned special sessions to discuss abortion legislation, which could include the issue. Lawmakers in Missouri have also supported the idea.
In contrast, several Democrat-led states have passed legislation this year to counteract laws that may try to restrict movement across state lines, according to the Post. Connecticut passed a law that offers protection from out-of-state subpoenas issued in cases related to abortion procedures that are legal in the state, and California passed a similar law to protect abortion providers and patients from civil suits.
The Justice Department has warned that it will fight laws that block people from crossing state lines, saying they violate the right to interstate commerce.
"The Constitution continues to restrict states' authority to ban reproductive services provided outside their borders," Attorney General Merrick Garland said in a statement after last week's ruling.
"We recognize that traveling to obtain reproductive care may not be feasible in many circumstances," he said. "But under bedrock constitutional principles, women who reside in states that have banned access to comprehensive reproductive care must remain free to seek that care in states where it is legal."
A version of this article first appeared on WebMD.com.
Vasectomy requests increase after Roe ruling
Urologists told The Washington Post that more men are seeking the procedure to prevent pregnancies and avoid abortion-related concerns.
“It was very, very noticeable [June 24], and then the number that came in over the weekend was huge, and the number that is still coming in far exceeds what we have experienced in the past,” Doug Stein, MD, a Florida urologist known as the “Vasectomy King” for his advocacy of the procedure, told the newspaper.
Before June 24, Dr. Stein received four or five vasectomy requests per day. But since then, that number has increased to 12 to 18 requests per day.
“Many of the guys are saying that they have been thinking about a vasectomy for a while, and the Roe v. Wade decision was just that final factor that tipped them over the edge and made them submit the online registration,” he said.
Urologists in California, Iowa, and New York also told the Post that they’ve seen a massive increase in the number of vasectomy consultations, as well as an increase in website traffic on their pages that offer information about vasectomies.
About 2 decades ago, Americans said the main reason they relied on a vasectomy as a form of birth control was that they or their partners had all the children they wanted. In the past decade, other reasons became more common, such as medical issues and problems with other types of birth control, the newspaper reported.
In anticipation of Roe v. Wade being overturned and anti-abortion legislation taking effect in states, advocates for vasectomies have encouraged people to get the procedure.
Dr. Stein said his practice is now booked through the end of August with vasectomy appointments, so he’s opening more days in his schedule to accommodate patients who submitted recent requests. He and his associate, John Curington, MD, said men under age 30 without children are requesting the procedure in greater numbers than before, with some citing the concurring opinion by Justice Clarence Thomas, which said the Supreme Court should reconsider other landmark cases that protect rights under the 14th Amendment, such as access to contraceptives.
“I’d say at least 60 or 70% are mentioning the Supreme Court decision,” Dr. Curington said, according to the Post. “And a few of them have such sophistication as young men that they actually are thinking about Justice Thomas and his opinion that contraception may fall next. And that’s shocking. That’s something that doesn’t enter into our conversations ever, until this week.”
A version of this article first appeared on WebMD.com.
Urologists told The Washington Post that more men are seeking the procedure to prevent pregnancies and avoid abortion-related concerns.
“It was very, very noticeable [June 24], and then the number that came in over the weekend was huge, and the number that is still coming in far exceeds what we have experienced in the past,” Doug Stein, MD, a Florida urologist known as the “Vasectomy King” for his advocacy of the procedure, told the newspaper.
Before June 24, Dr. Stein received four or five vasectomy requests per day. But since then, that number has increased to 12 to 18 requests per day.
“Many of the guys are saying that they have been thinking about a vasectomy for a while, and the Roe v. Wade decision was just that final factor that tipped them over the edge and made them submit the online registration,” he said.
Urologists in California, Iowa, and New York also told the Post that they’ve seen a massive increase in the number of vasectomy consultations, as well as an increase in website traffic on their pages that offer information about vasectomies.
About 2 decades ago, Americans said the main reason they relied on a vasectomy as a form of birth control was that they or their partners had all the children they wanted. In the past decade, other reasons became more common, such as medical issues and problems with other types of birth control, the newspaper reported.
In anticipation of Roe v. Wade being overturned and anti-abortion legislation taking effect in states, advocates for vasectomies have encouraged people to get the procedure.
Dr. Stein said his practice is now booked through the end of August with vasectomy appointments, so he’s opening more days in his schedule to accommodate patients who submitted recent requests. He and his associate, John Curington, MD, said men under age 30 without children are requesting the procedure in greater numbers than before, with some citing the concurring opinion by Justice Clarence Thomas, which said the Supreme Court should reconsider other landmark cases that protect rights under the 14th Amendment, such as access to contraceptives.
“I’d say at least 60 or 70% are mentioning the Supreme Court decision,” Dr. Curington said, according to the Post. “And a few of them have such sophistication as young men that they actually are thinking about Justice Thomas and his opinion that contraception may fall next. And that’s shocking. That’s something that doesn’t enter into our conversations ever, until this week.”
A version of this article first appeared on WebMD.com.
Urologists told The Washington Post that more men are seeking the procedure to prevent pregnancies and avoid abortion-related concerns.
“It was very, very noticeable [June 24], and then the number that came in over the weekend was huge, and the number that is still coming in far exceeds what we have experienced in the past,” Doug Stein, MD, a Florida urologist known as the “Vasectomy King” for his advocacy of the procedure, told the newspaper.
Before June 24, Dr. Stein received four or five vasectomy requests per day. But since then, that number has increased to 12 to 18 requests per day.
“Many of the guys are saying that they have been thinking about a vasectomy for a while, and the Roe v. Wade decision was just that final factor that tipped them over the edge and made them submit the online registration,” he said.
Urologists in California, Iowa, and New York also told the Post that they’ve seen a massive increase in the number of vasectomy consultations, as well as an increase in website traffic on their pages that offer information about vasectomies.
About 2 decades ago, Americans said the main reason they relied on a vasectomy as a form of birth control was that they or their partners had all the children they wanted. In the past decade, other reasons became more common, such as medical issues and problems with other types of birth control, the newspaper reported.
In anticipation of Roe v. Wade being overturned and anti-abortion legislation taking effect in states, advocates for vasectomies have encouraged people to get the procedure.
Dr. Stein said his practice is now booked through the end of August with vasectomy appointments, so he’s opening more days in his schedule to accommodate patients who submitted recent requests. He and his associate, John Curington, MD, said men under age 30 without children are requesting the procedure in greater numbers than before, with some citing the concurring opinion by Justice Clarence Thomas, which said the Supreme Court should reconsider other landmark cases that protect rights under the 14th Amendment, such as access to contraceptives.
“I’d say at least 60 or 70% are mentioning the Supreme Court decision,” Dr. Curington said, according to the Post. “And a few of them have such sophistication as young men that they actually are thinking about Justice Thomas and his opinion that contraception may fall next. And that’s shocking. That’s something that doesn’t enter into our conversations ever, until this week.”
A version of this article first appeared on WebMD.com.
Alabama cites Roe decision in call to ban transgender health care
Alabama urged a federal court on June 28 to drop its block on the state’s ban on gender-affirming care for transgender youth, citing the Supreme Court’s recent decision to overturn Roe v. Wade.
Alabama Attorney General Steve Marshall said the high court ruled that abortion isn’t protected under the 14th Amendment because it’s not “deeply rooted” in the nation’s history, which he noted could be said about access to gender-affirming care as well, according to Axios.
“No one – adult or child – has a right to transitioning treatments that is deeply rooted in our Nation’s history and tradition,” he wrote in a court document.
“The State can thus regulate or prohibit those interventions for children, even if an adult wants the drugs for his child,” he wrote.
In May, a federal judge blocked part of Alabama’s Senate Bill 184, which makes it a felony for someone to “engage in or cause” certain types of medical care for transgender youths. The law, which was put in place in April, allows for criminal prosecution against doctors, parents, guardians, and anyone else who provides care to a minor. The penalties could result in up to 10 years in prison and up to $15,000 in fines.
At that time, U.S. District Judge Liles Burke issued an injunction to stop Alabama from enforcing the law and allow challenges, including one filed by the Department of Justice. Mr. Burke said the state provided “no credible evidence to show that transitioning medications are ‘experimental.’ ”
“While Defendants offer some evidence that transitioning medications pose certain risks, the uncontradicted record evidence is that at least twenty-two major medical associations in the United States endorse transitioning medications as well-established, evidence-based treatments for gender dysphoria in minors,” he wrote in the ruling.
Medical organizations such as the American Academy of Pediatrics, American Psychological Association, and American Medical Association have urged governors to oppose legislation this year that would restrict gender-affirming medical care, saying that such laws could have negative effects on the mental health of transgender youths.
But on June 28, Mr. Marshall focused on the Constitution and what he believes the recent overturn of Roe implies.
“Just as the parental relationship does not unlock a Due Process right allowing parents to obtain medical marijuana or abortions for their children, neither does it unlock a right to transitioning treatments,” he wrote.
“The Constitution reserves to the State – not courts or medical interest groups – the authority to determine that these sterilizing interventions are too dangerous for minors,” he said.
Since the Supreme Court overturned Roe, people have expressed concerns that lawsuits could now target several rights that are protected under the 14th Amendment, including same-sex relationships, marriage equality, and access to contraceptives.
Justice Clarence Thomas, who wrote a concurring opinion to the majority decision, said the Supreme Court, “in future cases” should reconsider “substantive due process precedents” under previous landmark cases such as Griswold v. Connecticut, Lawrence v. Texas, and Obergefell v. Hodges.
At the same time, Justice Brett Kavanaugh, who also wrote a concurring opinion, said the decision to overturn Roe was only focused on abortion, saying it “does not mean the overruling of those precedents, and does not threaten or cast doubt on those precedents.”
A version of this article first appeared on WebMD.com.
Alabama urged a federal court on June 28 to drop its block on the state’s ban on gender-affirming care for transgender youth, citing the Supreme Court’s recent decision to overturn Roe v. Wade.
Alabama Attorney General Steve Marshall said the high court ruled that abortion isn’t protected under the 14th Amendment because it’s not “deeply rooted” in the nation’s history, which he noted could be said about access to gender-affirming care as well, according to Axios.
“No one – adult or child – has a right to transitioning treatments that is deeply rooted in our Nation’s history and tradition,” he wrote in a court document.
“The State can thus regulate or prohibit those interventions for children, even if an adult wants the drugs for his child,” he wrote.
In May, a federal judge blocked part of Alabama’s Senate Bill 184, which makes it a felony for someone to “engage in or cause” certain types of medical care for transgender youths. The law, which was put in place in April, allows for criminal prosecution against doctors, parents, guardians, and anyone else who provides care to a minor. The penalties could result in up to 10 years in prison and up to $15,000 in fines.
At that time, U.S. District Judge Liles Burke issued an injunction to stop Alabama from enforcing the law and allow challenges, including one filed by the Department of Justice. Mr. Burke said the state provided “no credible evidence to show that transitioning medications are ‘experimental.’ ”
“While Defendants offer some evidence that transitioning medications pose certain risks, the uncontradicted record evidence is that at least twenty-two major medical associations in the United States endorse transitioning medications as well-established, evidence-based treatments for gender dysphoria in minors,” he wrote in the ruling.
Medical organizations such as the American Academy of Pediatrics, American Psychological Association, and American Medical Association have urged governors to oppose legislation this year that would restrict gender-affirming medical care, saying that such laws could have negative effects on the mental health of transgender youths.
But on June 28, Mr. Marshall focused on the Constitution and what he believes the recent overturn of Roe implies.
“Just as the parental relationship does not unlock a Due Process right allowing parents to obtain medical marijuana or abortions for their children, neither does it unlock a right to transitioning treatments,” he wrote.
“The Constitution reserves to the State – not courts or medical interest groups – the authority to determine that these sterilizing interventions are too dangerous for minors,” he said.
Since the Supreme Court overturned Roe, people have expressed concerns that lawsuits could now target several rights that are protected under the 14th Amendment, including same-sex relationships, marriage equality, and access to contraceptives.
Justice Clarence Thomas, who wrote a concurring opinion to the majority decision, said the Supreme Court, “in future cases” should reconsider “substantive due process precedents” under previous landmark cases such as Griswold v. Connecticut, Lawrence v. Texas, and Obergefell v. Hodges.
At the same time, Justice Brett Kavanaugh, who also wrote a concurring opinion, said the decision to overturn Roe was only focused on abortion, saying it “does not mean the overruling of those precedents, and does not threaten or cast doubt on those precedents.”
A version of this article first appeared on WebMD.com.
Alabama urged a federal court on June 28 to drop its block on the state’s ban on gender-affirming care for transgender youth, citing the Supreme Court’s recent decision to overturn Roe v. Wade.
Alabama Attorney General Steve Marshall said the high court ruled that abortion isn’t protected under the 14th Amendment because it’s not “deeply rooted” in the nation’s history, which he noted could be said about access to gender-affirming care as well, according to Axios.
“No one – adult or child – has a right to transitioning treatments that is deeply rooted in our Nation’s history and tradition,” he wrote in a court document.
“The State can thus regulate or prohibit those interventions for children, even if an adult wants the drugs for his child,” he wrote.
In May, a federal judge blocked part of Alabama’s Senate Bill 184, which makes it a felony for someone to “engage in or cause” certain types of medical care for transgender youths. The law, which was put in place in April, allows for criminal prosecution against doctors, parents, guardians, and anyone else who provides care to a minor. The penalties could result in up to 10 years in prison and up to $15,000 in fines.
At that time, U.S. District Judge Liles Burke issued an injunction to stop Alabama from enforcing the law and allow challenges, including one filed by the Department of Justice. Mr. Burke said the state provided “no credible evidence to show that transitioning medications are ‘experimental.’ ”
“While Defendants offer some evidence that transitioning medications pose certain risks, the uncontradicted record evidence is that at least twenty-two major medical associations in the United States endorse transitioning medications as well-established, evidence-based treatments for gender dysphoria in minors,” he wrote in the ruling.
Medical organizations such as the American Academy of Pediatrics, American Psychological Association, and American Medical Association have urged governors to oppose legislation this year that would restrict gender-affirming medical care, saying that such laws could have negative effects on the mental health of transgender youths.
But on June 28, Mr. Marshall focused on the Constitution and what he believes the recent overturn of Roe implies.
“Just as the parental relationship does not unlock a Due Process right allowing parents to obtain medical marijuana or abortions for their children, neither does it unlock a right to transitioning treatments,” he wrote.
“The Constitution reserves to the State – not courts or medical interest groups – the authority to determine that these sterilizing interventions are too dangerous for minors,” he said.
Since the Supreme Court overturned Roe, people have expressed concerns that lawsuits could now target several rights that are protected under the 14th Amendment, including same-sex relationships, marriage equality, and access to contraceptives.
Justice Clarence Thomas, who wrote a concurring opinion to the majority decision, said the Supreme Court, “in future cases” should reconsider “substantive due process precedents” under previous landmark cases such as Griswold v. Connecticut, Lawrence v. Texas, and Obergefell v. Hodges.
At the same time, Justice Brett Kavanaugh, who also wrote a concurring opinion, said the decision to overturn Roe was only focused on abortion, saying it “does not mean the overruling of those precedents, and does not threaten or cast doubt on those precedents.”
A version of this article first appeared on WebMD.com.