FDA unveils 5-year plan for ALS and other neurodegenerative diseases

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Fri, 07/01/2022 - 12:00

 

The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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

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The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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

 

The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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

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White House expands access to monkeypox vaccines

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Tue, 07/05/2022 - 10:19

 

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

  • People who have had close physical contact with someone diagnosed with monkeypox.
  • People with a sexual partner diagnosed with monkeypox.
  • Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

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The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

  • People who have had close physical contact with someone diagnosed with monkeypox.
  • People with a sexual partner diagnosed with monkeypox.
  • Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

 

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

  • People who have had close physical contact with someone diagnosed with monkeypox.
  • People with a sexual partner diagnosed with monkeypox.
  • Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

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FDA panel backs adding Omicron component to COVID boosters

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Wed, 06/29/2022 - 16:27

A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

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A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

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Commentary: Locoregional Treatments for HCC, July 2022

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Thu, 07/07/2022 - 14:03
Dr. Damjanov scans the journals, so you don’t have to!

Nevena Damjanov, MD
Patients with unresected hepatocellular carcinoma (HCC) may be offered liver-directed therapies. This month we will review publications that report outcomes of patients managed with various locoregional treatments.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (90Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Author and Disclosure Information

Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

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Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

Author and Disclosure Information

Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

Dr. Damjanov scans the journals, so you don’t have to!
Dr. Damjanov scans the journals, so you don’t have to!

Nevena Damjanov, MD
Patients with unresected hepatocellular carcinoma (HCC) may be offered liver-directed therapies. This month we will review publications that report outcomes of patients managed with various locoregional treatments.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (90Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Nevena Damjanov, MD
Patients with unresected hepatocellular carcinoma (HCC) may be offered liver-directed therapies. This month we will review publications that report outcomes of patients managed with various locoregional treatments.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (90Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

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Commentary: Locoregional Treatments for HCC, July 2022

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Dr. Damjanov scans the journals, so you don’t have to!

Nevena Damjanov, MD
Patients with unresected hepatocellular carcinoma (HCC) may be offered liver-directed therapies. This month we will review publications that report outcomes of patients managed with various locoregional treatments.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (90Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

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Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology,  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

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Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology,  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

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Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology,  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

Dr. Damjanov scans the journals, so you don’t have to!
Dr. Damjanov scans the journals, so you don’t have to!

Nevena Damjanov, MD
Patients with unresected hepatocellular carcinoma (HCC) may be offered liver-directed therapies. This month we will review publications that report outcomes of patients managed with various locoregional treatments.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (90Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Nevena Damjanov, MD
Patients with unresected hepatocellular carcinoma (HCC) may be offered liver-directed therapies. This month we will review publications that report outcomes of patients managed with various locoregional treatments.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (90Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

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COVID subvariants could cause ‘substantial’ summer cases

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As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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

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As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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

As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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

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Commentary: Support for the Use of Dupilumab in AD, and a Link Between AD and Depression, July 2022

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Dr. Silverberg scans the journals, so you don’t have to!

Jonathan Silverberg, MD, PhD, MPH
In last month's commentary, I reviewed recent studies on five new drugs that were approved for atopic dermatitis (AD) in the past 5 years. Since then, dupilumab was approved by the US Food and Drug Administration for the treatment of moderate-to-severe AD in children ages 6 months to 5 years. It is exciting to have a safe and effective treatment to use across the life course. In addition, several new studies of dupilumab were published this month which fill important knowledge gaps regarding its use in the real world.

First, Blauvelt and colleagues presented findings from the ongoing LIBERTY AD PED-OLE open-label extension study, including 294 adolescents with moderate to severe AD who participated in previous dupilumab trials. Patients received a maintenance dose of 300 mg dupilumab every 4 weeks, which was increased to a weight-based every-other-week regimen if there was inadequate clinical response to every-4-week dosing. They found that 81.2% of patients achieved an Eczema Area and Severity Index (EASI-75) response at week 52 with every-4-week dosing, and 51.9% of patients at week 48 after switching to every-2-week doing. These results indicate that some adolescents may be able to maintain clinical efficacy with monthly dosing, while others may require every-2-week dosing. Of note, no new safety signals emerged during the study and most adverse events were mild to moderate.

Two more studies were published showing real-world effectiveness and safety of dupilumab. Eichenfield and colleagues performed a retrospective, observational study of the effectiveness of dupilumab after 4 months of treatment using data from national electronic medical records in adults with moderate-to-severe AD. They found that most patients achieved at least a one-grade (81.8%) or two-grade (62.8%) improvement of their Investigator's Global Assessment (IGA) scores, with 42.8% achieving IGA scores of 0/1 (clear/minimal). There were also significant improvements in itch and lesional extent. The results were remarkably similar to those observed in the phase 3 clinical trial program of dupilumab in adults with moderate-to-severe AD.

Bagel and colleagues published baseline characteristics of patients enrolled in the ongoing PROSE longitudinal real-world registry of dupilumab use in adults with moderate-to-severe AD. Almost half of the patients (49.5%) previously received systemic medications, including 41.0% with systemic corticosteroids, 16.8% with nonsteroidal systemic therapies, such as cyclosporine and methotrexate, and 10.2% with phototherapy. This result indicates that many medical professionals are not using dupilumab as a first-line systemic therapy, despite its established record on safety and efficacy. It appears that many clinicians prefer a short-term treatment regimen, such as systemic corticosteroids, prior to initiating long-term treatment with dupilumab. However, short-term treatment approaches are not ideal for this chronic and often lifelong disease. It is important that clinicians develop appropriate long-term treatment approaches for atopic dermatitis in general, regardless of any specific therapy.

On a different research note, my research group just published the results of a longitudinal dermatology practice–based study of depressive symptoms in 695 adults with AD over time.1 We found that approximately half of the patients experienced fluctuating severity of depressive symptoms, and 45.65% experienced persistent severity of depression. Severity of AD lesions and itch were the strongest predictors of more severe symptoms of depression. Perhaps most fascinating about this research was that symptoms of depression improved dramatically in a very large subset of patients who experienced reduced AD severity with standard-of-care treatment. These results highlight the broader impacts of AD on mental health, which were recently recognized by the American Academy of Dermatology's guideline update on AD comorbidities.2 Moreover, our study demonstrated that many of these mental health impacts were modifiable with optimized AD therapy.

Additional References

1.         Chatrath S, Lei D, Yousaf M, et al. vc Longitudinal course and predictors of depressive symptoms in atopic dermatitis. J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

2.         Davis DMR, Drucker AM, Alikhan A, et al. American Academy of Dermatology Guidelines: Awareness of comorbidities associated with atopic dermatitis in adults. J Am Acad Dermatol. 2022;86:1335-1336.e18. Doi: 10.1016/j.jaad.2022.01.009

 

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George Washington University School of Medicine and Health Sciences
Washington, DC

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Dr. Silverberg scans the journals, so you don’t have to!
Dr. Silverberg scans the journals, so you don’t have to!

Jonathan Silverberg, MD, PhD, MPH
In last month's commentary, I reviewed recent studies on five new drugs that were approved for atopic dermatitis (AD) in the past 5 years. Since then, dupilumab was approved by the US Food and Drug Administration for the treatment of moderate-to-severe AD in children ages 6 months to 5 years. It is exciting to have a safe and effective treatment to use across the life course. In addition, several new studies of dupilumab were published this month which fill important knowledge gaps regarding its use in the real world.

First, Blauvelt and colleagues presented findings from the ongoing LIBERTY AD PED-OLE open-label extension study, including 294 adolescents with moderate to severe AD who participated in previous dupilumab trials. Patients received a maintenance dose of 300 mg dupilumab every 4 weeks, which was increased to a weight-based every-other-week regimen if there was inadequate clinical response to every-4-week dosing. They found that 81.2% of patients achieved an Eczema Area and Severity Index (EASI-75) response at week 52 with every-4-week dosing, and 51.9% of patients at week 48 after switching to every-2-week doing. These results indicate that some adolescents may be able to maintain clinical efficacy with monthly dosing, while others may require every-2-week dosing. Of note, no new safety signals emerged during the study and most adverse events were mild to moderate.

Two more studies were published showing real-world effectiveness and safety of dupilumab. Eichenfield and colleagues performed a retrospective, observational study of the effectiveness of dupilumab after 4 months of treatment using data from national electronic medical records in adults with moderate-to-severe AD. They found that most patients achieved at least a one-grade (81.8%) or two-grade (62.8%) improvement of their Investigator's Global Assessment (IGA) scores, with 42.8% achieving IGA scores of 0/1 (clear/minimal). There were also significant improvements in itch and lesional extent. The results were remarkably similar to those observed in the phase 3 clinical trial program of dupilumab in adults with moderate-to-severe AD.

Bagel and colleagues published baseline characteristics of patients enrolled in the ongoing PROSE longitudinal real-world registry of dupilumab use in adults with moderate-to-severe AD. Almost half of the patients (49.5%) previously received systemic medications, including 41.0% with systemic corticosteroids, 16.8% with nonsteroidal systemic therapies, such as cyclosporine and methotrexate, and 10.2% with phototherapy. This result indicates that many medical professionals are not using dupilumab as a first-line systemic therapy, despite its established record on safety and efficacy. It appears that many clinicians prefer a short-term treatment regimen, such as systemic corticosteroids, prior to initiating long-term treatment with dupilumab. However, short-term treatment approaches are not ideal for this chronic and often lifelong disease. It is important that clinicians develop appropriate long-term treatment approaches for atopic dermatitis in general, regardless of any specific therapy.

On a different research note, my research group just published the results of a longitudinal dermatology practice–based study of depressive symptoms in 695 adults with AD over time.1 We found that approximately half of the patients experienced fluctuating severity of depressive symptoms, and 45.65% experienced persistent severity of depression. Severity of AD lesions and itch were the strongest predictors of more severe symptoms of depression. Perhaps most fascinating about this research was that symptoms of depression improved dramatically in a very large subset of patients who experienced reduced AD severity with standard-of-care treatment. These results highlight the broader impacts of AD on mental health, which were recently recognized by the American Academy of Dermatology's guideline update on AD comorbidities.2 Moreover, our study demonstrated that many of these mental health impacts were modifiable with optimized AD therapy.

Additional References

1.         Chatrath S, Lei D, Yousaf M, et al. vc Longitudinal course and predictors of depressive symptoms in atopic dermatitis. J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

2.         Davis DMR, Drucker AM, Alikhan A, et al. American Academy of Dermatology Guidelines: Awareness of comorbidities associated with atopic dermatitis in adults. J Am Acad Dermatol. 2022;86:1335-1336.e18. Doi: 10.1016/j.jaad.2022.01.009

 

Jonathan Silverberg, MD, PhD, MPH
In last month's commentary, I reviewed recent studies on five new drugs that were approved for atopic dermatitis (AD) in the past 5 years. Since then, dupilumab was approved by the US Food and Drug Administration for the treatment of moderate-to-severe AD in children ages 6 months to 5 years. It is exciting to have a safe and effective treatment to use across the life course. In addition, several new studies of dupilumab were published this month which fill important knowledge gaps regarding its use in the real world.

First, Blauvelt and colleagues presented findings from the ongoing LIBERTY AD PED-OLE open-label extension study, including 294 adolescents with moderate to severe AD who participated in previous dupilumab trials. Patients received a maintenance dose of 300 mg dupilumab every 4 weeks, which was increased to a weight-based every-other-week regimen if there was inadequate clinical response to every-4-week dosing. They found that 81.2% of patients achieved an Eczema Area and Severity Index (EASI-75) response at week 52 with every-4-week dosing, and 51.9% of patients at week 48 after switching to every-2-week doing. These results indicate that some adolescents may be able to maintain clinical efficacy with monthly dosing, while others may require every-2-week dosing. Of note, no new safety signals emerged during the study and most adverse events were mild to moderate.

Two more studies were published showing real-world effectiveness and safety of dupilumab. Eichenfield and colleagues performed a retrospective, observational study of the effectiveness of dupilumab after 4 months of treatment using data from national electronic medical records in adults with moderate-to-severe AD. They found that most patients achieved at least a one-grade (81.8%) or two-grade (62.8%) improvement of their Investigator's Global Assessment (IGA) scores, with 42.8% achieving IGA scores of 0/1 (clear/minimal). There were also significant improvements in itch and lesional extent. The results were remarkably similar to those observed in the phase 3 clinical trial program of dupilumab in adults with moderate-to-severe AD.

Bagel and colleagues published baseline characteristics of patients enrolled in the ongoing PROSE longitudinal real-world registry of dupilumab use in adults with moderate-to-severe AD. Almost half of the patients (49.5%) previously received systemic medications, including 41.0% with systemic corticosteroids, 16.8% with nonsteroidal systemic therapies, such as cyclosporine and methotrexate, and 10.2% with phototherapy. This result indicates that many medical professionals are not using dupilumab as a first-line systemic therapy, despite its established record on safety and efficacy. It appears that many clinicians prefer a short-term treatment regimen, such as systemic corticosteroids, prior to initiating long-term treatment with dupilumab. However, short-term treatment approaches are not ideal for this chronic and often lifelong disease. It is important that clinicians develop appropriate long-term treatment approaches for atopic dermatitis in general, regardless of any specific therapy.

On a different research note, my research group just published the results of a longitudinal dermatology practice–based study of depressive symptoms in 695 adults with AD over time.1 We found that approximately half of the patients experienced fluctuating severity of depressive symptoms, and 45.65% experienced persistent severity of depression. Severity of AD lesions and itch were the strongest predictors of more severe symptoms of depression. Perhaps most fascinating about this research was that symptoms of depression improved dramatically in a very large subset of patients who experienced reduced AD severity with standard-of-care treatment. These results highlight the broader impacts of AD on mental health, which were recently recognized by the American Academy of Dermatology's guideline update on AD comorbidities.2 Moreover, our study demonstrated that many of these mental health impacts were modifiable with optimized AD therapy.

Additional References

1.         Chatrath S, Lei D, Yousaf M, et al. vc Longitudinal course and predictors of depressive symptoms in atopic dermatitis. J Am Acad Dermatol. 2022 (May 9). Doi: 10.1016/j.jaad.2022.04.061

2.         Davis DMR, Drucker AM, Alikhan A, et al. American Academy of Dermatology Guidelines: Awareness of comorbidities associated with atopic dermatitis in adults. J Am Acad Dermatol. 2022;86:1335-1336.e18. Doi: 10.1016/j.jaad.2022.01.009

 

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Race drives disparities in life expectancy across states

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Life expectancy in the United States plateaued in recent years, and persistent racial disparities vary by state, according to an analysis of death records and Census data from 1990 to 2019.

“Life expectancy is an important measure of the health of the entire population,” corresponding author Gregory Roth, MD, a cardiologist at the University of Washington, Seattle, said in an interview. “We know race, ethnicity and where you live all affect health, but we wanted to look at the long arc over many decades to understand where subpopulations have been, and where they are headed. Also, it is important to understand how race and place interact, so we looked at race/ethnicity groups within each state to see where disparities exist that need to be addressed.”

In the study, published in Annals of Internal Medicine, researchers led by Catherine O. Johnson, PhD, of the University of Washington, Seattle, reviewed data from 23 states, using regression models based on Census data and deidentified death records. They examined life expectancy for subgroups of individuals reporting Hispanic, non-Hispanic Black, or non-Hispanic White race or ethnicity.

Overall, most states showed an improvement in life expectancy between 1990 and 2019. For women, the mean life expectancy across states increased from 79.3 years in 1990 to 81.3 years in 2019. For men, the mean life expectancy across states increased from 72.6 years in 1990 to 76.3 years in 2019.

However, the researchers found significant disparities across the three racial subgroups between and within states when life expectancy was examined by race/ethnicity, independent of the average life expectancy for an entire state overall. They defined disparity as the difference in life expectancy between states for those in different racial/ethnic groups.

Without considering race/ethnicity, disparities in life expectancy across states decreased from 8.0 years and 12.2 years in 1990 to 7.9 and 7.8 years in 2019, for females and males, respectively.

When race/ethnicity was taken into account, disparities in life expectancy decreased, but the differences across states were greater than when race was not considered; 20.7 years for females and 24.5 years for males in 1990, decreasing to 18.5 years for females and 23.7 years for males in 2019.

Despite the overall improvements, disparities in life expectancy persisted across all states within each race/ethnicity group.

Among females, for example, non-Hispanic Black females had the lowest mean life expectancy across states in 1990 (74.2 years) but had the greatest improvement on average (6.9% increase) by 2019. However, the mean LE for non-Hispanic Black females remained lower than it did for non-Hispanic White and Hispanic females.

Among males, the researchers found differences in life expectancies across states between the people of the three different ethnicities they studied. The greatest difference in life expectancies in 1990 was 24.5 years. This occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Georgia. The life expectancy for these non-Hispanic Black males was 59.4 years, versus 83.8 years for these Hispanic males that year.

This reduced life expectancy for non-Hispanic Black males persisted, although it improved slightly by 2019. That year, the largest race-based disparity – which was approximately 24 years – occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Virginia. For the Hispanic males in Virgina, the LE was 90.7 years versus 66.9 years for non-Hispanic Black males in the District of Columbia.

The findings were limited by several factors including the review of data from only 23 states, the focus on life expectancy from birth versus other ages, and the challenges of defining Hispanic ethnicity, the researchers noted. However, the results support that the potential use of state-level analysis that includes race/ethnicity could be a valuable tool for measuring health inequity as part of national average trends, they said.
 

 

 

Health has truly stagnated for some in certain states

“Subpopulations in some states have much longer life expectancy now than 30 years ago. But in some states, we were struck by how health has truly stagnated for some,” Dr. Roth said in an interview. “We were surprised by the scale of the overall gap; a difference of about 8 years between states is more than twice that if you drill down to race/ethnicity groups in each state.”

A key message from the study is the need for all clinicians to advocate for improved access to primary care, “which is increasingly hard to obtain for many people,” said Dr. Roth. “So much of health is determined by key risk factors such as high blood pressure, high cholesterol, obesity, diabetes, alcohol use, tobacco use. But many of the determinants of health are not in the healthcare system, and include efforts to improve education, interrupt cycles of poverty, and teach healthy behaviors at a very young age. “Racism remains a underdiscussed part of these disparities, and we need better ways to measure the impact of social policies that end up impacting health down the road,” he said.

Looking ahead: “There is a lot to be learned from the states that have improved life expectancy the most. We need researchers to work together to identify and communicate what are those best practices, and what state governments can do to play their part.”

State-level differences reveal variations in health care

“The findings add to our growing knowledge of large and persistent racial/ethnic health disparities and changes in disparities during recent stagnation in U.S. life expectancy,” wrote Hedwig Lee, PhD, of Washington University in St. Louis, and Kathleen M. Harris, PhD, of the University of North Carolina at Chapel Hill, in an accompanying editorial.

The focus on state-level differences provides a unique window into the huge variation in life expectancy by race/ethnicity across the United States. The data suggest that “a person’s life expectancy in the United States may depend more on where you live than it has in the past,” they noted. For example, the editorialists highlighted that life expectancy for non-Hispanic Black men in 2019 averaged 81.1 years in Rhode Island, but 66.9 years in the District of Columbia.

They also noted the study’s lack of data for many states with high mortality rates and high proportions of non-Hispanic Black persons, Hispanic persons, and those with low socioeconomic states. Including data from these areas may have yielded even greater disparities in life expectancy.

“Despite substantial declines in mortality among Black persons during the study period, a non-Hispanic Black person’s life expectancy remained persistently lower than that of non-Hispanic White and Hispanic persons, both within and across states,” the editorialists wrote. “Future research needs to unpack the complex web of factors driving health and well-being by enabling better understanding of the places where we see persistent health disadvantage and advantage and the state-based explanations for these increasingly important differences determining population risk and resilience. We should be outraged by disparities in longevity and called to act to eliminate them.”
 

 

 

Identifying the problem is the first step

“In order to address or fix a problem we should first identify and quantify the problem,” Noel Deep, MD, an internal medicine physician in private practice in Antigo, Wisc., said in an interview.

“This study provides us with the information regarding the trends in life expectancy within states and the disparities in life expectancy when race/ ethnicity and gender are factored into the equation,” said Dr. Deep, who was not involved in the study. “Based on previously available data, we are aware of the increase in life expectancy in the United States over the last few decades, as well as differences in life expectancy for the different ethnicities/races and genders, but these data provide averages, not state or geographical differences. By having this knowledge at a state level, we can use that data to make health policies that address those health inequities and allocate appropriate resources at a state or local level.”

Several studies have identified disparities in health care and life expectancy based on the zip codes, such as the U.S. Small-Area Life Expectancy Estimates Project in 2018. The current study “provides further information for health care professionals and policy makers about the disparities in health outcomes and life expectancy based on race as well as gender, and it is quite detailed,” he said. 

“As clinicians, we should strive to ensure that we are addressing these health inequities through our provision of clinical care and through our advocacy on behalf of our patients so that our nation’s health will improve overall,” he said.

“I would like to see future studies look at the socioeconomic status (income), urban versus rural residence, and place of birth (especially for immigrants),” said Dr. Deep. He also emphasized a need for studies to include the demographics for Hispanic populations; given the possible selection error “because of only healthy individuals immigrating to the United States or the older sicker Hispanics who might be migrating back to their homelands and not being included in the data and falsely increasing the life expectancy for this race/ ethnic groups.

“I would also like to see some research into the cultural and social factors that might explain why Hispanic populations might have a higher life expectancy even if their socioeconomic status is poor,” he said.

The study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News and as chair of the AMA’s Council on Science and Public Health.

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Life expectancy in the United States plateaued in recent years, and persistent racial disparities vary by state, according to an analysis of death records and Census data from 1990 to 2019.

“Life expectancy is an important measure of the health of the entire population,” corresponding author Gregory Roth, MD, a cardiologist at the University of Washington, Seattle, said in an interview. “We know race, ethnicity and where you live all affect health, but we wanted to look at the long arc over many decades to understand where subpopulations have been, and where they are headed. Also, it is important to understand how race and place interact, so we looked at race/ethnicity groups within each state to see where disparities exist that need to be addressed.”

In the study, published in Annals of Internal Medicine, researchers led by Catherine O. Johnson, PhD, of the University of Washington, Seattle, reviewed data from 23 states, using regression models based on Census data and deidentified death records. They examined life expectancy for subgroups of individuals reporting Hispanic, non-Hispanic Black, or non-Hispanic White race or ethnicity.

Overall, most states showed an improvement in life expectancy between 1990 and 2019. For women, the mean life expectancy across states increased from 79.3 years in 1990 to 81.3 years in 2019. For men, the mean life expectancy across states increased from 72.6 years in 1990 to 76.3 years in 2019.

However, the researchers found significant disparities across the three racial subgroups between and within states when life expectancy was examined by race/ethnicity, independent of the average life expectancy for an entire state overall. They defined disparity as the difference in life expectancy between states for those in different racial/ethnic groups.

Without considering race/ethnicity, disparities in life expectancy across states decreased from 8.0 years and 12.2 years in 1990 to 7.9 and 7.8 years in 2019, for females and males, respectively.

When race/ethnicity was taken into account, disparities in life expectancy decreased, but the differences across states were greater than when race was not considered; 20.7 years for females and 24.5 years for males in 1990, decreasing to 18.5 years for females and 23.7 years for males in 2019.

Despite the overall improvements, disparities in life expectancy persisted across all states within each race/ethnicity group.

Among females, for example, non-Hispanic Black females had the lowest mean life expectancy across states in 1990 (74.2 years) but had the greatest improvement on average (6.9% increase) by 2019. However, the mean LE for non-Hispanic Black females remained lower than it did for non-Hispanic White and Hispanic females.

Among males, the researchers found differences in life expectancies across states between the people of the three different ethnicities they studied. The greatest difference in life expectancies in 1990 was 24.5 years. This occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Georgia. The life expectancy for these non-Hispanic Black males was 59.4 years, versus 83.8 years for these Hispanic males that year.

This reduced life expectancy for non-Hispanic Black males persisted, although it improved slightly by 2019. That year, the largest race-based disparity – which was approximately 24 years – occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Virginia. For the Hispanic males in Virgina, the LE was 90.7 years versus 66.9 years for non-Hispanic Black males in the District of Columbia.

The findings were limited by several factors including the review of data from only 23 states, the focus on life expectancy from birth versus other ages, and the challenges of defining Hispanic ethnicity, the researchers noted. However, the results support that the potential use of state-level analysis that includes race/ethnicity could be a valuable tool for measuring health inequity as part of national average trends, they said.
 

 

 

Health has truly stagnated for some in certain states

“Subpopulations in some states have much longer life expectancy now than 30 years ago. But in some states, we were struck by how health has truly stagnated for some,” Dr. Roth said in an interview. “We were surprised by the scale of the overall gap; a difference of about 8 years between states is more than twice that if you drill down to race/ethnicity groups in each state.”

A key message from the study is the need for all clinicians to advocate for improved access to primary care, “which is increasingly hard to obtain for many people,” said Dr. Roth. “So much of health is determined by key risk factors such as high blood pressure, high cholesterol, obesity, diabetes, alcohol use, tobacco use. But many of the determinants of health are not in the healthcare system, and include efforts to improve education, interrupt cycles of poverty, and teach healthy behaviors at a very young age. “Racism remains a underdiscussed part of these disparities, and we need better ways to measure the impact of social policies that end up impacting health down the road,” he said.

Looking ahead: “There is a lot to be learned from the states that have improved life expectancy the most. We need researchers to work together to identify and communicate what are those best practices, and what state governments can do to play their part.”

State-level differences reveal variations in health care

“The findings add to our growing knowledge of large and persistent racial/ethnic health disparities and changes in disparities during recent stagnation in U.S. life expectancy,” wrote Hedwig Lee, PhD, of Washington University in St. Louis, and Kathleen M. Harris, PhD, of the University of North Carolina at Chapel Hill, in an accompanying editorial.

The focus on state-level differences provides a unique window into the huge variation in life expectancy by race/ethnicity across the United States. The data suggest that “a person’s life expectancy in the United States may depend more on where you live than it has in the past,” they noted. For example, the editorialists highlighted that life expectancy for non-Hispanic Black men in 2019 averaged 81.1 years in Rhode Island, but 66.9 years in the District of Columbia.

They also noted the study’s lack of data for many states with high mortality rates and high proportions of non-Hispanic Black persons, Hispanic persons, and those with low socioeconomic states. Including data from these areas may have yielded even greater disparities in life expectancy.

“Despite substantial declines in mortality among Black persons during the study period, a non-Hispanic Black person’s life expectancy remained persistently lower than that of non-Hispanic White and Hispanic persons, both within and across states,” the editorialists wrote. “Future research needs to unpack the complex web of factors driving health and well-being by enabling better understanding of the places where we see persistent health disadvantage and advantage and the state-based explanations for these increasingly important differences determining population risk and resilience. We should be outraged by disparities in longevity and called to act to eliminate them.”
 

 

 

Identifying the problem is the first step

“In order to address or fix a problem we should first identify and quantify the problem,” Noel Deep, MD, an internal medicine physician in private practice in Antigo, Wisc., said in an interview.

“This study provides us with the information regarding the trends in life expectancy within states and the disparities in life expectancy when race/ ethnicity and gender are factored into the equation,” said Dr. Deep, who was not involved in the study. “Based on previously available data, we are aware of the increase in life expectancy in the United States over the last few decades, as well as differences in life expectancy for the different ethnicities/races and genders, but these data provide averages, not state or geographical differences. By having this knowledge at a state level, we can use that data to make health policies that address those health inequities and allocate appropriate resources at a state or local level.”

Several studies have identified disparities in health care and life expectancy based on the zip codes, such as the U.S. Small-Area Life Expectancy Estimates Project in 2018. The current study “provides further information for health care professionals and policy makers about the disparities in health outcomes and life expectancy based on race as well as gender, and it is quite detailed,” he said. 

“As clinicians, we should strive to ensure that we are addressing these health inequities through our provision of clinical care and through our advocacy on behalf of our patients so that our nation’s health will improve overall,” he said.

“I would like to see future studies look at the socioeconomic status (income), urban versus rural residence, and place of birth (especially for immigrants),” said Dr. Deep. He also emphasized a need for studies to include the demographics for Hispanic populations; given the possible selection error “because of only healthy individuals immigrating to the United States or the older sicker Hispanics who might be migrating back to their homelands and not being included in the data and falsely increasing the life expectancy for this race/ ethnic groups.

“I would also like to see some research into the cultural and social factors that might explain why Hispanic populations might have a higher life expectancy even if their socioeconomic status is poor,” he said.

The study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News and as chair of the AMA’s Council on Science and Public Health.

Life expectancy in the United States plateaued in recent years, and persistent racial disparities vary by state, according to an analysis of death records and Census data from 1990 to 2019.

“Life expectancy is an important measure of the health of the entire population,” corresponding author Gregory Roth, MD, a cardiologist at the University of Washington, Seattle, said in an interview. “We know race, ethnicity and where you live all affect health, but we wanted to look at the long arc over many decades to understand where subpopulations have been, and where they are headed. Also, it is important to understand how race and place interact, so we looked at race/ethnicity groups within each state to see where disparities exist that need to be addressed.”

In the study, published in Annals of Internal Medicine, researchers led by Catherine O. Johnson, PhD, of the University of Washington, Seattle, reviewed data from 23 states, using regression models based on Census data and deidentified death records. They examined life expectancy for subgroups of individuals reporting Hispanic, non-Hispanic Black, or non-Hispanic White race or ethnicity.

Overall, most states showed an improvement in life expectancy between 1990 and 2019. For women, the mean life expectancy across states increased from 79.3 years in 1990 to 81.3 years in 2019. For men, the mean life expectancy across states increased from 72.6 years in 1990 to 76.3 years in 2019.

However, the researchers found significant disparities across the three racial subgroups between and within states when life expectancy was examined by race/ethnicity, independent of the average life expectancy for an entire state overall. They defined disparity as the difference in life expectancy between states for those in different racial/ethnic groups.

Without considering race/ethnicity, disparities in life expectancy across states decreased from 8.0 years and 12.2 years in 1990 to 7.9 and 7.8 years in 2019, for females and males, respectively.

When race/ethnicity was taken into account, disparities in life expectancy decreased, but the differences across states were greater than when race was not considered; 20.7 years for females and 24.5 years for males in 1990, decreasing to 18.5 years for females and 23.7 years for males in 2019.

Despite the overall improvements, disparities in life expectancy persisted across all states within each race/ethnicity group.

Among females, for example, non-Hispanic Black females had the lowest mean life expectancy across states in 1990 (74.2 years) but had the greatest improvement on average (6.9% increase) by 2019. However, the mean LE for non-Hispanic Black females remained lower than it did for non-Hispanic White and Hispanic females.

Among males, the researchers found differences in life expectancies across states between the people of the three different ethnicities they studied. The greatest difference in life expectancies in 1990 was 24.5 years. This occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Georgia. The life expectancy for these non-Hispanic Black males was 59.4 years, versus 83.8 years for these Hispanic males that year.

This reduced life expectancy for non-Hispanic Black males persisted, although it improved slightly by 2019. That year, the largest race-based disparity – which was approximately 24 years – occurred between non-Hispanic Black males in the District of Columbia and Hispanic males in Virginia. For the Hispanic males in Virgina, the LE was 90.7 years versus 66.9 years for non-Hispanic Black males in the District of Columbia.

The findings were limited by several factors including the review of data from only 23 states, the focus on life expectancy from birth versus other ages, and the challenges of defining Hispanic ethnicity, the researchers noted. However, the results support that the potential use of state-level analysis that includes race/ethnicity could be a valuable tool for measuring health inequity as part of national average trends, they said.
 

 

 

Health has truly stagnated for some in certain states

“Subpopulations in some states have much longer life expectancy now than 30 years ago. But in some states, we were struck by how health has truly stagnated for some,” Dr. Roth said in an interview. “We were surprised by the scale of the overall gap; a difference of about 8 years between states is more than twice that if you drill down to race/ethnicity groups in each state.”

A key message from the study is the need for all clinicians to advocate for improved access to primary care, “which is increasingly hard to obtain for many people,” said Dr. Roth. “So much of health is determined by key risk factors such as high blood pressure, high cholesterol, obesity, diabetes, alcohol use, tobacco use. But many of the determinants of health are not in the healthcare system, and include efforts to improve education, interrupt cycles of poverty, and teach healthy behaviors at a very young age. “Racism remains a underdiscussed part of these disparities, and we need better ways to measure the impact of social policies that end up impacting health down the road,” he said.

Looking ahead: “There is a lot to be learned from the states that have improved life expectancy the most. We need researchers to work together to identify and communicate what are those best practices, and what state governments can do to play their part.”

State-level differences reveal variations in health care

“The findings add to our growing knowledge of large and persistent racial/ethnic health disparities and changes in disparities during recent stagnation in U.S. life expectancy,” wrote Hedwig Lee, PhD, of Washington University in St. Louis, and Kathleen M. Harris, PhD, of the University of North Carolina at Chapel Hill, in an accompanying editorial.

The focus on state-level differences provides a unique window into the huge variation in life expectancy by race/ethnicity across the United States. The data suggest that “a person’s life expectancy in the United States may depend more on where you live than it has in the past,” they noted. For example, the editorialists highlighted that life expectancy for non-Hispanic Black men in 2019 averaged 81.1 years in Rhode Island, but 66.9 years in the District of Columbia.

They also noted the study’s lack of data for many states with high mortality rates and high proportions of non-Hispanic Black persons, Hispanic persons, and those with low socioeconomic states. Including data from these areas may have yielded even greater disparities in life expectancy.

“Despite substantial declines in mortality among Black persons during the study period, a non-Hispanic Black person’s life expectancy remained persistently lower than that of non-Hispanic White and Hispanic persons, both within and across states,” the editorialists wrote. “Future research needs to unpack the complex web of factors driving health and well-being by enabling better understanding of the places where we see persistent health disadvantage and advantage and the state-based explanations for these increasingly important differences determining population risk and resilience. We should be outraged by disparities in longevity and called to act to eliminate them.”
 

 

 

Identifying the problem is the first step

“In order to address or fix a problem we should first identify and quantify the problem,” Noel Deep, MD, an internal medicine physician in private practice in Antigo, Wisc., said in an interview.

“This study provides us with the information regarding the trends in life expectancy within states and the disparities in life expectancy when race/ ethnicity and gender are factored into the equation,” said Dr. Deep, who was not involved in the study. “Based on previously available data, we are aware of the increase in life expectancy in the United States over the last few decades, as well as differences in life expectancy for the different ethnicities/races and genders, but these data provide averages, not state or geographical differences. By having this knowledge at a state level, we can use that data to make health policies that address those health inequities and allocate appropriate resources at a state or local level.”

Several studies have identified disparities in health care and life expectancy based on the zip codes, such as the U.S. Small-Area Life Expectancy Estimates Project in 2018. The current study “provides further information for health care professionals and policy makers about the disparities in health outcomes and life expectancy based on race as well as gender, and it is quite detailed,” he said. 

“As clinicians, we should strive to ensure that we are addressing these health inequities through our provision of clinical care and through our advocacy on behalf of our patients so that our nation’s health will improve overall,” he said.

“I would like to see future studies look at the socioeconomic status (income), urban versus rural residence, and place of birth (especially for immigrants),” said Dr. Deep. He also emphasized a need for studies to include the demographics for Hispanic populations; given the possible selection error “because of only healthy individuals immigrating to the United States or the older sicker Hispanics who might be migrating back to their homelands and not being included in the data and falsely increasing the life expectancy for this race/ ethnic groups.

“I would also like to see some research into the cultural and social factors that might explain why Hispanic populations might have a higher life expectancy even if their socioeconomic status is poor,” he said.

The study was supported by the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. The editorialists had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News and as chair of the AMA’s Council on Science and Public Health.

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Facebook, Instagram remove posts offering abortion pills

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Thu, 06/30/2022 - 07:40

Facebook and Instagram have begun removing posts and temporarily banning users that offer abortion pills to women who may not be able to access them after the Supreme Court overruled Roe v. Wade.

After the decision was overturned on June 24, social media posts exploded across platforms during the weekend, explaining how women could legally obtain abortion pills in the mail. Some offered to mail the prescriptions to women in states that now ban the procedure.

General posts about abortion pills, as well as ones that mentioned specific versions such as mifepristone and misoprostol, spiked on Friday morning across Facebook, Instagram, Reddit, and Twitter. By Sunday, more than 250,000 mentions had been posted, the media intelligence firm Zignal Labs told The Associated Press.

But Meta, the parent company of Facebook and Instagram, began removing some of these posts almost right away, the AP reported. Journalists at news outlets saved screenshots of posts that offered pills and were removed minutes later. Users were notified that they were banned, according to Vice.

On June 24, a Vice reporter posted the phrase “abortion pills can be mailed” on Facebook, which was flagged within seconds for violating the platform’s community rules against buying, selling, or trading medical or nonmedical drugs. The reporter was given the option to “agree” or “disagree” with the decision, and after they chose to “disagree,” the post was removed.

On June 27, the post that Vice “disagreed” had violated the standards was reinstated, the news outlet reported. The reporter wrote a new post with the phrase “abortion pills can be mailed,” which was flagged instantly for removal. After the reporter “agreed” with the decision, the account was suspended for 24 hours.

Similarly on June 27, a reporter for the AP wrote a post on Facebook that said, “If you send me your address, I will mail you abortion pills.” The post was removed within 1 minute, and the account was put on a “warning” status for the post. Other posts that offered “a gun” or “weed” were not flagged or removed, the AP reported.

Marijuana is illegal under federal law and can’t be sent through the mail, the AP reported. But abortion pills can be obtained through the mail legally.

Meta won’t allow people to gift or sell pharmaceuticals on its platform but will allow posts that share information about accessing pills, Andy Stone, a Meta spokesperson, wrote in a Twitter comment in response to the Vice article on June 27.

“Content that attempts to buy, sell, trade, gift, request, or donate pharmaceuticals is not allowed,” he wrote. “Content that discusses the affordability and accessibility of prescription medication is allowed. We’ve discovered some instances of incorrect enforcement and are correcting these.”

U.S. Attorney General Merrick Garland said on June 24 that the Food and Drug Administration has approved the use of mifepristone for medication abortion up to 10 weeks. In 2021, the FDA also made it possible and legal to send abortion pills via mail.

“States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” he said in a statement.

At the same time, some Republican lawmakers have tried to stop residents from getting abortion pills through the mail, the AP reported. States such as Tennessee and West Virginia have prohibited providers from prescribing the medication through telemedicine consultations, and Texas has made it illegal to send abortion pills through the mail.

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

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Facebook and Instagram have begun removing posts and temporarily banning users that offer abortion pills to women who may not be able to access them after the Supreme Court overruled Roe v. Wade.

After the decision was overturned on June 24, social media posts exploded across platforms during the weekend, explaining how women could legally obtain abortion pills in the mail. Some offered to mail the prescriptions to women in states that now ban the procedure.

General posts about abortion pills, as well as ones that mentioned specific versions such as mifepristone and misoprostol, spiked on Friday morning across Facebook, Instagram, Reddit, and Twitter. By Sunday, more than 250,000 mentions had been posted, the media intelligence firm Zignal Labs told The Associated Press.

But Meta, the parent company of Facebook and Instagram, began removing some of these posts almost right away, the AP reported. Journalists at news outlets saved screenshots of posts that offered pills and were removed minutes later. Users were notified that they were banned, according to Vice.

On June 24, a Vice reporter posted the phrase “abortion pills can be mailed” on Facebook, which was flagged within seconds for violating the platform’s community rules against buying, selling, or trading medical or nonmedical drugs. The reporter was given the option to “agree” or “disagree” with the decision, and after they chose to “disagree,” the post was removed.

On June 27, the post that Vice “disagreed” had violated the standards was reinstated, the news outlet reported. The reporter wrote a new post with the phrase “abortion pills can be mailed,” which was flagged instantly for removal. After the reporter “agreed” with the decision, the account was suspended for 24 hours.

Similarly on June 27, a reporter for the AP wrote a post on Facebook that said, “If you send me your address, I will mail you abortion pills.” The post was removed within 1 minute, and the account was put on a “warning” status for the post. Other posts that offered “a gun” or “weed” were not flagged or removed, the AP reported.

Marijuana is illegal under federal law and can’t be sent through the mail, the AP reported. But abortion pills can be obtained through the mail legally.

Meta won’t allow people to gift or sell pharmaceuticals on its platform but will allow posts that share information about accessing pills, Andy Stone, a Meta spokesperson, wrote in a Twitter comment in response to the Vice article on June 27.

“Content that attempts to buy, sell, trade, gift, request, or donate pharmaceuticals is not allowed,” he wrote. “Content that discusses the affordability and accessibility of prescription medication is allowed. We’ve discovered some instances of incorrect enforcement and are correcting these.”

U.S. Attorney General Merrick Garland said on June 24 that the Food and Drug Administration has approved the use of mifepristone for medication abortion up to 10 weeks. In 2021, the FDA also made it possible and legal to send abortion pills via mail.

“States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” he said in a statement.

At the same time, some Republican lawmakers have tried to stop residents from getting abortion pills through the mail, the AP reported. States such as Tennessee and West Virginia have prohibited providers from prescribing the medication through telemedicine consultations, and Texas has made it illegal to send abortion pills through the mail.

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

Facebook and Instagram have begun removing posts and temporarily banning users that offer abortion pills to women who may not be able to access them after the Supreme Court overruled Roe v. Wade.

After the decision was overturned on June 24, social media posts exploded across platforms during the weekend, explaining how women could legally obtain abortion pills in the mail. Some offered to mail the prescriptions to women in states that now ban the procedure.

General posts about abortion pills, as well as ones that mentioned specific versions such as mifepristone and misoprostol, spiked on Friday morning across Facebook, Instagram, Reddit, and Twitter. By Sunday, more than 250,000 mentions had been posted, the media intelligence firm Zignal Labs told The Associated Press.

But Meta, the parent company of Facebook and Instagram, began removing some of these posts almost right away, the AP reported. Journalists at news outlets saved screenshots of posts that offered pills and were removed minutes later. Users were notified that they were banned, according to Vice.

On June 24, a Vice reporter posted the phrase “abortion pills can be mailed” on Facebook, which was flagged within seconds for violating the platform’s community rules against buying, selling, or trading medical or nonmedical drugs. The reporter was given the option to “agree” or “disagree” with the decision, and after they chose to “disagree,” the post was removed.

On June 27, the post that Vice “disagreed” had violated the standards was reinstated, the news outlet reported. The reporter wrote a new post with the phrase “abortion pills can be mailed,” which was flagged instantly for removal. After the reporter “agreed” with the decision, the account was suspended for 24 hours.

Similarly on June 27, a reporter for the AP wrote a post on Facebook that said, “If you send me your address, I will mail you abortion pills.” The post was removed within 1 minute, and the account was put on a “warning” status for the post. Other posts that offered “a gun” or “weed” were not flagged or removed, the AP reported.

Marijuana is illegal under federal law and can’t be sent through the mail, the AP reported. But abortion pills can be obtained through the mail legally.

Meta won’t allow people to gift or sell pharmaceuticals on its platform but will allow posts that share information about accessing pills, Andy Stone, a Meta spokesperson, wrote in a Twitter comment in response to the Vice article on June 27.

“Content that attempts to buy, sell, trade, gift, request, or donate pharmaceuticals is not allowed,” he wrote. “Content that discusses the affordability and accessibility of prescription medication is allowed. We’ve discovered some instances of incorrect enforcement and are correcting these.”

U.S. Attorney General Merrick Garland said on June 24 that the Food and Drug Administration has approved the use of mifepristone for medication abortion up to 10 weeks. In 2021, the FDA also made it possible and legal to send abortion pills via mail.

“States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” he said in a statement.

At the same time, some Republican lawmakers have tried to stop residents from getting abortion pills through the mail, the AP reported. States such as Tennessee and West Virginia have prohibited providers from prescribing the medication through telemedicine consultations, and Texas has made it illegal to send abortion pills through the mail.

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

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Post–Roe v. Wade: What’s next?

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Wed, 06/29/2022 - 09:46

The U.S. Supreme Court’s decision to overturn Roe v. Wade, the landmark ruling in 1973 establishing a constitutional right to abortion, has spurred abortion rights supporters and opponents into action, speeding up their efforts to protect or remove access to abortion.

For now, the fight moves to the states, where so-called trigger laws have already banned nearly all abortions in a handful of states. More will likely take effect soon.

“Half of [the states] are going to have quite restrictive abortion laws, and about half will pretty much maintain the status quo,” said Ron Allen, JD, a constitutional law expert and professor of law at Northwestern University, Chicago. “My guess is, the largest population will be in those states that maintain the status quo, [though] that’s not terribly consoling to somebody in Arkansas, [which has a trigger law.]”

Federal and state officials spoke out quickly about what protections are still in place for access to abortion, and some governors have taken new actions to expand that protection.

While abortion rights advocates called on Congress to pass legislation legalizing abortion access nationwide, others, including former Vice President Mike Pence, said a national ban on abortions should be the next step.
 

Federal, state protections

President Joe Biden quickly addressed the issue of women needing to travel out of state to access abortion. In his statement on June 24, he said: “So if a woman lives in a state that restricts abortion, the Supreme Court’s decision does not prevent her from traveling from her home state to the state that allows it. It does not prevent a doctor in that state from treating her.”

In a statement also issued June 24, Attorney General Merrick Garland expressed strong disagreement with the court’s decision and also pointed out it does not mean that states can’t keep abortion legal within their borders. Nor can states ban reproductive services provided to their residents outside their own borders.

Women living in states banning access to abortion, “must be free to seek care in states where it is legal.” Others are free to inform and counsel each other about reproductive care available in other states, he said, citing the First Amendment.

Doctors who provide abortion services in states where the services remain legal, as well as patients who receive the services, will be protected under the Freedom of Access to Clinic Entrances Act, Mr. Garland said in a statement from the Department of Justice.

States reiterated protection for health care providers. For instance, California Gov. Gavin Newsom signed a law June 24 protecting California abortion providers from civil liability when they provide care for women traveling from states where abortion is banned or access to it is narrowed.

Officials from other states with abortion access began publicizing their status as “safe havens.” New York Attorney General Letitia James tweeted: “While other states strip away the fundamental right to choose, New York will always be a safe haven for anyone seeking an abortion.”

Gov. Newsom, too, among other state officials, has promised his state would be a sanctuary for women in need.

After the ruling, New York Gov. Kathy Hochul and the New York State Department of Health launched a new website and campaign, Abortion Access Always, providing a single destination for information about rights, providers, support, and other details.
 

 

 

Abortion pill

Mr. Garland and President Biden strongly warned states not to try to interfere with access to the so-called abortion pill. Approved 20 years ago by the FDA to safely end early pregnancies, the medication, mifepristone (formerly called RU-486) is taken along with misoprostol, a drug also used to prevent stomach ulcers. Medication abortion now accounts for more than half of all abortions, according to the Guttmacher Institute.

In his statement, Mr. Garland noted that the “FDA has approved the use of the medication mifepristone. States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

Plan C, an information campaign for abortion services, has a state-by-state directory of ways to find the pills, even in states restricting access to abortion, said Elisa Wells, Plan C’s cofounder and codirector.
 

Calls for national access

On June 24, President Biden called on Congress to restore the protections of Roe v. Wade as federal law. “No executive action from the president can do that,” he said. If Congress lacks the vote to do that now, voters need to make their voices heard, he said.

“The Supreme Court is but one of many government bodies that can protect the right to abortion,” Nancy Northup, JD, president and CEO of the Center for Reproductive Rights, New York, said June 24. “We will be looking to the Congress to pass the Women’s Health Protection Act. Congress can solve this as a national problem. We’ll be looking to the Biden administration to use the extent of its powers.”

The Women’s Health Protection Act would prohibit government restrictions on access to abortion services.

Sen. Bernie Sanders (I-Vt.) tweeted: “Democrats must now end the filibuster in the Senate, codify Roe v. Wade, and once again make abortion legal and safe.”

“The federal government can do a lot of things,” said Mr. Allen. “It’s interesting that we focus on the administrative agencies. The fight over Roe is a fight in large measure over who should be deciding and whether these are issues that should be decided by agencies or a court or legislators.”

Anger, he said, “should be directed at legislators, and that’s who should be acting here, and that means people have to get out and vote.”
 

Calls for a national ban

Former Vice President Pence told far-right publication Breitbart News that the court’s decision should lead to a national ban on abortion.

He also took to Twitter. Among other posts, he said: “Having been given this second chance for Life, we must not rest and must not relent until the sanctity of life is restored to the center of American law in every state in the land!”
 

Organizations’ actions

Organizations on both sides of the issue have mobilization and expansion plans.

NRLC: The National Right to Life Committee will now focus on state legislatures, said Laura Echevarria, the group’s communications director.

“We will continue to work on these [antiabortion] laws in the states we can get these passed,” she said. There’s no one size fits all. “New York is not going to pass a law that Alabama is going to pass. Every state is going to be doing something different.”

“The next big thing is to build that safety net” for women who decide to avoid abortion, she said. More than 2,700 “pregnancy help” centers operate in the United States. “We don’t run them, they are independent.” But the NRLC supports them. The centers provide pregnancy support and financial help, “two big reasons why women get abortions.”

She added: “The prolife movement often gets a bad rap, like we don’t care about women, and we do.” In an open letter issued May 12 to state lawmakers, the NRLC said: “We state unequivocally that we do not support any measure seeking to criminalize or punish women and we stand firmly opposed to include such penalties in legislation.”

ACLU: Anthony D. Romero, JD, executive director of the American Civil Liberties Union, issued a statement on Jun 24 that read in part: “Second-class status for women has once again become the law because of today’s decisions.”

As the fight plays out in the court, the ACLU urges voters to head to the polls, noting that state constitutional amendments to preserve reproductive freedom are on the ballot in Kansas in August and in Vermont and Kentucky in November.
 

Planned Parenthood

“A majority of justices ruled to throw away nearly 50 years of precedent and take away the right to control our bodies and personal health care decisions,” the Planned Parenthood site posted.

On June 25, the Planned Parenthood Association of Utah filed suit in Utah state court, planning to request a temporary restraining order against the state’s ban on abortion at any point in pregnancy. The law took effect June 24.
 

Abortion rights offers of help

As legislators and public officials focused on what the next steps should be, social media lit up over the weekend with offers of help for women in states without access to abortion.

One meme posted on social media focused on “camping.” Reportedly created by a woman who needed abortions before the 1973 Roe v. Wade decision, it reads: “If you are a person who suddenly finds yourself with a need to go camping in another state friendly towards camping, just know that I will happily drive you, support you, and not talk about the camping trip to anyone ever.”

While the camping code word quickly picked up steam, one Twitter user who favored the court’s decision called the trend of using camping as a code word to help people access abortions “horrible.”

TikTok users also offered their homes and help to women from other states who might need either. And one Airbnb host posted this invitation on Facebook: “My Airbnb is free for any American woman coming to Los Angeles for an abortion. Hugs and cute kittens, too.”

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

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The U.S. Supreme Court’s decision to overturn Roe v. Wade, the landmark ruling in 1973 establishing a constitutional right to abortion, has spurred abortion rights supporters and opponents into action, speeding up their efforts to protect or remove access to abortion.

For now, the fight moves to the states, where so-called trigger laws have already banned nearly all abortions in a handful of states. More will likely take effect soon.

“Half of [the states] are going to have quite restrictive abortion laws, and about half will pretty much maintain the status quo,” said Ron Allen, JD, a constitutional law expert and professor of law at Northwestern University, Chicago. “My guess is, the largest population will be in those states that maintain the status quo, [though] that’s not terribly consoling to somebody in Arkansas, [which has a trigger law.]”

Federal and state officials spoke out quickly about what protections are still in place for access to abortion, and some governors have taken new actions to expand that protection.

While abortion rights advocates called on Congress to pass legislation legalizing abortion access nationwide, others, including former Vice President Mike Pence, said a national ban on abortions should be the next step.
 

Federal, state protections

President Joe Biden quickly addressed the issue of women needing to travel out of state to access abortion. In his statement on June 24, he said: “So if a woman lives in a state that restricts abortion, the Supreme Court’s decision does not prevent her from traveling from her home state to the state that allows it. It does not prevent a doctor in that state from treating her.”

In a statement also issued June 24, Attorney General Merrick Garland expressed strong disagreement with the court’s decision and also pointed out it does not mean that states can’t keep abortion legal within their borders. Nor can states ban reproductive services provided to their residents outside their own borders.

Women living in states banning access to abortion, “must be free to seek care in states where it is legal.” Others are free to inform and counsel each other about reproductive care available in other states, he said, citing the First Amendment.

Doctors who provide abortion services in states where the services remain legal, as well as patients who receive the services, will be protected under the Freedom of Access to Clinic Entrances Act, Mr. Garland said in a statement from the Department of Justice.

States reiterated protection for health care providers. For instance, California Gov. Gavin Newsom signed a law June 24 protecting California abortion providers from civil liability when they provide care for women traveling from states where abortion is banned or access to it is narrowed.

Officials from other states with abortion access began publicizing their status as “safe havens.” New York Attorney General Letitia James tweeted: “While other states strip away the fundamental right to choose, New York will always be a safe haven for anyone seeking an abortion.”

Gov. Newsom, too, among other state officials, has promised his state would be a sanctuary for women in need.

After the ruling, New York Gov. Kathy Hochul and the New York State Department of Health launched a new website and campaign, Abortion Access Always, providing a single destination for information about rights, providers, support, and other details.
 

 

 

Abortion pill

Mr. Garland and President Biden strongly warned states not to try to interfere with access to the so-called abortion pill. Approved 20 years ago by the FDA to safely end early pregnancies, the medication, mifepristone (formerly called RU-486) is taken along with misoprostol, a drug also used to prevent stomach ulcers. Medication abortion now accounts for more than half of all abortions, according to the Guttmacher Institute.

In his statement, Mr. Garland noted that the “FDA has approved the use of the medication mifepristone. States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

Plan C, an information campaign for abortion services, has a state-by-state directory of ways to find the pills, even in states restricting access to abortion, said Elisa Wells, Plan C’s cofounder and codirector.
 

Calls for national access

On June 24, President Biden called on Congress to restore the protections of Roe v. Wade as federal law. “No executive action from the president can do that,” he said. If Congress lacks the vote to do that now, voters need to make their voices heard, he said.

“The Supreme Court is but one of many government bodies that can protect the right to abortion,” Nancy Northup, JD, president and CEO of the Center for Reproductive Rights, New York, said June 24. “We will be looking to the Congress to pass the Women’s Health Protection Act. Congress can solve this as a national problem. We’ll be looking to the Biden administration to use the extent of its powers.”

The Women’s Health Protection Act would prohibit government restrictions on access to abortion services.

Sen. Bernie Sanders (I-Vt.) tweeted: “Democrats must now end the filibuster in the Senate, codify Roe v. Wade, and once again make abortion legal and safe.”

“The federal government can do a lot of things,” said Mr. Allen. “It’s interesting that we focus on the administrative agencies. The fight over Roe is a fight in large measure over who should be deciding and whether these are issues that should be decided by agencies or a court or legislators.”

Anger, he said, “should be directed at legislators, and that’s who should be acting here, and that means people have to get out and vote.”
 

Calls for a national ban

Former Vice President Pence told far-right publication Breitbart News that the court’s decision should lead to a national ban on abortion.

He also took to Twitter. Among other posts, he said: “Having been given this second chance for Life, we must not rest and must not relent until the sanctity of life is restored to the center of American law in every state in the land!”
 

Organizations’ actions

Organizations on both sides of the issue have mobilization and expansion plans.

NRLC: The National Right to Life Committee will now focus on state legislatures, said Laura Echevarria, the group’s communications director.

“We will continue to work on these [antiabortion] laws in the states we can get these passed,” she said. There’s no one size fits all. “New York is not going to pass a law that Alabama is going to pass. Every state is going to be doing something different.”

“The next big thing is to build that safety net” for women who decide to avoid abortion, she said. More than 2,700 “pregnancy help” centers operate in the United States. “We don’t run them, they are independent.” But the NRLC supports them. The centers provide pregnancy support and financial help, “two big reasons why women get abortions.”

She added: “The prolife movement often gets a bad rap, like we don’t care about women, and we do.” In an open letter issued May 12 to state lawmakers, the NRLC said: “We state unequivocally that we do not support any measure seeking to criminalize or punish women and we stand firmly opposed to include such penalties in legislation.”

ACLU: Anthony D. Romero, JD, executive director of the American Civil Liberties Union, issued a statement on Jun 24 that read in part: “Second-class status for women has once again become the law because of today’s decisions.”

As the fight plays out in the court, the ACLU urges voters to head to the polls, noting that state constitutional amendments to preserve reproductive freedom are on the ballot in Kansas in August and in Vermont and Kentucky in November.
 

Planned Parenthood

“A majority of justices ruled to throw away nearly 50 years of precedent and take away the right to control our bodies and personal health care decisions,” the Planned Parenthood site posted.

On June 25, the Planned Parenthood Association of Utah filed suit in Utah state court, planning to request a temporary restraining order against the state’s ban on abortion at any point in pregnancy. The law took effect June 24.
 

Abortion rights offers of help

As legislators and public officials focused on what the next steps should be, social media lit up over the weekend with offers of help for women in states without access to abortion.

One meme posted on social media focused on “camping.” Reportedly created by a woman who needed abortions before the 1973 Roe v. Wade decision, it reads: “If you are a person who suddenly finds yourself with a need to go camping in another state friendly towards camping, just know that I will happily drive you, support you, and not talk about the camping trip to anyone ever.”

While the camping code word quickly picked up steam, one Twitter user who favored the court’s decision called the trend of using camping as a code word to help people access abortions “horrible.”

TikTok users also offered their homes and help to women from other states who might need either. And one Airbnb host posted this invitation on Facebook: “My Airbnb is free for any American woman coming to Los Angeles for an abortion. Hugs and cute kittens, too.”

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

The U.S. Supreme Court’s decision to overturn Roe v. Wade, the landmark ruling in 1973 establishing a constitutional right to abortion, has spurred abortion rights supporters and opponents into action, speeding up their efforts to protect or remove access to abortion.

For now, the fight moves to the states, where so-called trigger laws have already banned nearly all abortions in a handful of states. More will likely take effect soon.

“Half of [the states] are going to have quite restrictive abortion laws, and about half will pretty much maintain the status quo,” said Ron Allen, JD, a constitutional law expert and professor of law at Northwestern University, Chicago. “My guess is, the largest population will be in those states that maintain the status quo, [though] that’s not terribly consoling to somebody in Arkansas, [which has a trigger law.]”

Federal and state officials spoke out quickly about what protections are still in place for access to abortion, and some governors have taken new actions to expand that protection.

While abortion rights advocates called on Congress to pass legislation legalizing abortion access nationwide, others, including former Vice President Mike Pence, said a national ban on abortions should be the next step.
 

Federal, state protections

President Joe Biden quickly addressed the issue of women needing to travel out of state to access abortion. In his statement on June 24, he said: “So if a woman lives in a state that restricts abortion, the Supreme Court’s decision does not prevent her from traveling from her home state to the state that allows it. It does not prevent a doctor in that state from treating her.”

In a statement also issued June 24, Attorney General Merrick Garland expressed strong disagreement with the court’s decision and also pointed out it does not mean that states can’t keep abortion legal within their borders. Nor can states ban reproductive services provided to their residents outside their own borders.

Women living in states banning access to abortion, “must be free to seek care in states where it is legal.” Others are free to inform and counsel each other about reproductive care available in other states, he said, citing the First Amendment.

Doctors who provide abortion services in states where the services remain legal, as well as patients who receive the services, will be protected under the Freedom of Access to Clinic Entrances Act, Mr. Garland said in a statement from the Department of Justice.

States reiterated protection for health care providers. For instance, California Gov. Gavin Newsom signed a law June 24 protecting California abortion providers from civil liability when they provide care for women traveling from states where abortion is banned or access to it is narrowed.

Officials from other states with abortion access began publicizing their status as “safe havens.” New York Attorney General Letitia James tweeted: “While other states strip away the fundamental right to choose, New York will always be a safe haven for anyone seeking an abortion.”

Gov. Newsom, too, among other state officials, has promised his state would be a sanctuary for women in need.

After the ruling, New York Gov. Kathy Hochul and the New York State Department of Health launched a new website and campaign, Abortion Access Always, providing a single destination for information about rights, providers, support, and other details.
 

 

 

Abortion pill

Mr. Garland and President Biden strongly warned states not to try to interfere with access to the so-called abortion pill. Approved 20 years ago by the FDA to safely end early pregnancies, the medication, mifepristone (formerly called RU-486) is taken along with misoprostol, a drug also used to prevent stomach ulcers. Medication abortion now accounts for more than half of all abortions, according to the Guttmacher Institute.

In his statement, Mr. Garland noted that the “FDA has approved the use of the medication mifepristone. States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

Plan C, an information campaign for abortion services, has a state-by-state directory of ways to find the pills, even in states restricting access to abortion, said Elisa Wells, Plan C’s cofounder and codirector.
 

Calls for national access

On June 24, President Biden called on Congress to restore the protections of Roe v. Wade as federal law. “No executive action from the president can do that,” he said. If Congress lacks the vote to do that now, voters need to make their voices heard, he said.

“The Supreme Court is but one of many government bodies that can protect the right to abortion,” Nancy Northup, JD, president and CEO of the Center for Reproductive Rights, New York, said June 24. “We will be looking to the Congress to pass the Women’s Health Protection Act. Congress can solve this as a national problem. We’ll be looking to the Biden administration to use the extent of its powers.”

The Women’s Health Protection Act would prohibit government restrictions on access to abortion services.

Sen. Bernie Sanders (I-Vt.) tweeted: “Democrats must now end the filibuster in the Senate, codify Roe v. Wade, and once again make abortion legal and safe.”

“The federal government can do a lot of things,” said Mr. Allen. “It’s interesting that we focus on the administrative agencies. The fight over Roe is a fight in large measure over who should be deciding and whether these are issues that should be decided by agencies or a court or legislators.”

Anger, he said, “should be directed at legislators, and that’s who should be acting here, and that means people have to get out and vote.”
 

Calls for a national ban

Former Vice President Pence told far-right publication Breitbart News that the court’s decision should lead to a national ban on abortion.

He also took to Twitter. Among other posts, he said: “Having been given this second chance for Life, we must not rest and must not relent until the sanctity of life is restored to the center of American law in every state in the land!”
 

Organizations’ actions

Organizations on both sides of the issue have mobilization and expansion plans.

NRLC: The National Right to Life Committee will now focus on state legislatures, said Laura Echevarria, the group’s communications director.

“We will continue to work on these [antiabortion] laws in the states we can get these passed,” she said. There’s no one size fits all. “New York is not going to pass a law that Alabama is going to pass. Every state is going to be doing something different.”

“The next big thing is to build that safety net” for women who decide to avoid abortion, she said. More than 2,700 “pregnancy help” centers operate in the United States. “We don’t run them, they are independent.” But the NRLC supports them. The centers provide pregnancy support and financial help, “two big reasons why women get abortions.”

She added: “The prolife movement often gets a bad rap, like we don’t care about women, and we do.” In an open letter issued May 12 to state lawmakers, the NRLC said: “We state unequivocally that we do not support any measure seeking to criminalize or punish women and we stand firmly opposed to include such penalties in legislation.”

ACLU: Anthony D. Romero, JD, executive director of the American Civil Liberties Union, issued a statement on Jun 24 that read in part: “Second-class status for women has once again become the law because of today’s decisions.”

As the fight plays out in the court, the ACLU urges voters to head to the polls, noting that state constitutional amendments to preserve reproductive freedom are on the ballot in Kansas in August and in Vermont and Kentucky in November.
 

Planned Parenthood

“A majority of justices ruled to throw away nearly 50 years of precedent and take away the right to control our bodies and personal health care decisions,” the Planned Parenthood site posted.

On June 25, the Planned Parenthood Association of Utah filed suit in Utah state court, planning to request a temporary restraining order against the state’s ban on abortion at any point in pregnancy. The law took effect June 24.
 

Abortion rights offers of help

As legislators and public officials focused on what the next steps should be, social media lit up over the weekend with offers of help for women in states without access to abortion.

One meme posted on social media focused on “camping.” Reportedly created by a woman who needed abortions before the 1973 Roe v. Wade decision, it reads: “If you are a person who suddenly finds yourself with a need to go camping in another state friendly towards camping, just know that I will happily drive you, support you, and not talk about the camping trip to anyone ever.”

While the camping code word quickly picked up steam, one Twitter user who favored the court’s decision called the trend of using camping as a code word to help people access abortions “horrible.”

TikTok users also offered their homes and help to women from other states who might need either. And one Airbnb host posted this invitation on Facebook: “My Airbnb is free for any American woman coming to Los Angeles for an abortion. Hugs and cute kittens, too.”

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

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