Gynecology

Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.

“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.

“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.

The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.

The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.

Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.

The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.

Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.

There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).

Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.

The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”

Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).

Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.

“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.

“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.

The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.

The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.

Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.

The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.

Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.

There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).

Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.

The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”

Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).

Abortion rates remained stable and adverse events were rare after removal of mifepristone prescribing restrictions in Canada, a new study shows.

“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a press release.

“This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions – meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when, and where they choose,” said lead author Laura Schummers, ScD, a postdoctoral fellow in the same department.

The findings “add to the accumulating evidence that removing restrictions from medication abortion is safe, effective, and improves access,” agreed Eve Espey, MD, professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, who was not part of the research team. “This is additional confirmation that it is safe for patients to receive abortion care medications in the ‘normal’ fashion, through a prescription available at a pharmacy,” she said in an interview.

The study, published in the New England Journal of Medicine, compared medical abortion use, safety, and effectiveness in the province of Ontario before the Canadian availability of mifepristone and after it became available without restrictions that are similar to the Risk Evaluation and Mitigation Strategy (REMS) restrictions in place for mifepristone in the United States.

Using linked administrative health data, the researchers created a population-based cohort of all Ontario residents aged 12-49 years who had received abortion services during the study period. In total, 195,183 abortions were performed in the period before mifepristone was approved (January 2012–December 2016), and 84,032 were performed after it was made available without restrictions (Nov. 7, 2017, through March 15, 2020). The vast majority of these abortions (89.3%) were surgical, with about 10% being medically induced, the authors reported.

The study found that, while the overall abortion rate declined over the study period (from 11.9 to 11.3 per 1,000 female residents), the proportion of medical abortions jumped sharply from 2.2% to 31.4%, and the rate of second-trimester abortions declined from 5.5% of all abortions to 5.1%.

Abortion safety outcomes within 6 weeks of abortion remained stable over the two study periods. This included severe adverse events (0.03% vs. 0.04%) such as blood transfusions, abdominal surgery, admission to an ICU, or sepsis during an abortion-related hospitalization; and complications (0.74% vs. 0.69%,) such as genital tract or pelvic infection, hemorrhage, embolism, shock, renal failure, damage to pelvic organs or tissues, and venous complications among other things.

There were slight declines in overall abortion effectiveness, but ongoing pregnancy rates “remained infrequent,” the authors noted. While there was a modest rise in the rates of subsequent uterine evacuation (from 1.0% to 2.2%), and ongoing intrauterine pregnancy continuing until delivery (from 0.03% to 0.08%), the rate of ectopic pregnancy diagnosed within 6 weeks after the abortion date remained stable (from 0.15% to 0.22%).

Canada was the first country in the world to remove all supplemental restrictions on the dispensing and administration of mifepristone, according to the press release. And while professional organizations have called for the removal of such restrictions “because they impede access to abortion services without improving safety,” high-quality data on this are lacking, they added.

The study’s finding are consistent with existing U.S. and U.K. data showing Food and Drug Administration REMS restrictions requiring abortion care medications to be dispensed in a clinic by a certified provider “are unnecessary and create obstacles to early abortion access,” said Dr. Espey. “For clinicians and patients in the U.S., it’s important to note that the increasing number of legislative restrictions on abortion, including medication abortion, are non–evidence based. Politically motivated false claims of safety concerns are countered by this study and others conducted during the pandemic when both the U.S. and U.K. removed REMS-type restrictions. These studies show that receiving abortion care through usual pharmacy channels and through telemedicine is safe, effective, and reduces barriers to care.”

Dr. Norman reported receiving grants from the Canadian Institutes of Health Research, providing expert witness services to the government of Ontario and Office of the Attorney General, and serving on the board of directors of the Society of Family Planning. No other researchers reported conflicts of interest. Dr. Espey reported no conflicts of interest. The Canadian Institutes of Health Research and the Women’s Health Research Institute with the support of ICES (formerly known as the Institute for Clinical Evaluative Sciences).

American teenagers receive less formal sex education today than they did 25 years ago, with “troubling” racial inequities that leave youth of color and queer youth at greater risk than other teens for sexually transmitted diseases and unintended pregnancy, according to a new study.

“Many adolescents do not receive any instruction on essential topics or do not receive this instruction until after the first sex,” wrote Laura D. Lindberg, PhD, and Leslie M. Kantor, PhD, MPH, from the Guttmacher Institute, New York, and the department of urban-global public health at Rutgers University, Piscataway, N.J., respectively. “These gaps in sex education in the U.S. are uneven, and gender, racial, and other disparities are widespread,” they added, calling for “robust efforts ... to ensure equity and reduce health disparities.”

The study used cross-sectional data from the 2011-2015 and 2015-2019 National Surveys of Family Growth (NSFG) to examine content, timing, and location of formal sex education among 15- to 19-year-olds in the United States. The data came from samples of 2,047 females and 2,087 males in 2011-2015, and 1,894 females and 1,918 males in 2015-2019. The majority of respondents were aged 15-17 years and non-Hispanic White, with another quarter being Hispanic, and 14% Black.

The survey asked respondents whether, before they turned 18, they had ever received formal instruction at school, church, a community center, “or some other place” about how to say no to sex, methods of birth control, STDs, how to prevent HIV/AIDS, abstaining until marriage to have sex, where to get birth control, and how to use a condom.

Follow-up questions asked about what grade instruction was first received and whether it had occurred before first penile-vaginal intercourse. The 2015-2019 survey also asked about the location of instruction, but only concerning methods of birth control and abstinence until marriage.

The results showed that HIV and STD prevention was the most commonly reported area of instruction, received by more than 90% of both males and females. However, beyond this there were imbalances, with only about half (49%-55%) of respondents receiving instruction meeting the Surgeon General’s Healthy People 2030 composite sex education goal. Lack of instruction on birth control drove this result for 80% of respondents. Specifically, there was a strong slant emphasizing abstinence over birth control instruction. Over both survey periods and both genders, more respondents reported instruction on how to say no to sex (79%-84%) and abstaining until marriage (58%-73%), compared with where to obtain birth control (40%-53%) or how to use a condom (54%-60%). “Overall, about 20% of adolescents received instruction from multiple sources about waiting until marriage, but only 5%-8% received birth control information from multiple settings,” they reported.

There were racial/ethnic and sexual orientation differences in the scope and balance of instruction reported by teens. Less than half of Black (45%) and Hispanic (47%) males received instruction on the combined Healthy People topics, compared with 57% of White males. Black females were less likely (30%) than White females (45%) to receive information on where to get birth control before the first sex. Nonstraight males were less likely than straight males to receive instruction about STIs or HIV/AIDS (83% vs. 93%).

In addition, religious attendance emerged as a key factor in the receipt of sex education, “with more frequent religious attendance associated with a greater likelihood of instruction about delaying sex and less likelihood of instruction about contraception,” the authors noted.

Comparing their findings to previous NSFG surveys, the researchers commented that “the share of adolescents receiving instruction about birth control was higher in 1995 than in 2015-2019 for both the genders; in 1995, 87% of females and 81% of males reported sex education about birth control methods, compared with 64% and 63% in 2015-2019, respectively.” The findings “should spur policy makers at the national, state, and local levels to ensure the broader provision of sex education and that school districts serving young people of color are the focus of additional efforts and funding.”

Asked for comment, John Santelli, MD, MPH, professor of population and family health and pediatrics at Columbia University, New York, who was not involved with the study, said the findings fit into a series of studies by Lindberg going back to 1988 showing that receipt of formal sex education before age 18 has declined over time.

“We, the adults, in America can do better by our young people,” he said in an interview. “Adolescents need sex education that is science based, medically accurate, and developmentally appropriate. Many adolescents are not receiving education that the CDC and health professionals recommend including information about where to get birth control, condom skills, and even, how to say no to sex. The neglect of young Black and Hispanic men is very concerning. However, we are not doing a great job in educating most of our adolescents. Health care providers can be influential in speaking with parents about their children’s education about sex. We need to activate parents, health care providers, and members of the faith community to investigate what is happening about sex education in their own communities.”

Dr. Santelli noted that there are multiple ways to strengthen the provision of sex education in the United States. In a recent commentary, he and his coauthors highlighted the National Sex Education Standards (NSES), which, “developed in partnership between sex education organizations and health professionals, provide clear, consistent, and straightforward guidance on the essential content for students in grades K-12.” The NSES were also used in the development of the CDC’s recently released Health Education Curriculum Analysis Tool.

The commentary takes a strong stand against the recently released revised Medical Institute for Sexual Heath K-12 Standards for Optimal Sexual Development, which, compared with the NSES, are “seriously flawed from both scientific and human rights’ perspectives,” they wrote. “States and local communities aiming to improve adolescent sexual and reproductive health and looking for national standards on sex education should adopt the NSES.”

Dr. Lindberg and Dr. Kantor disclosed no conflicts of interest. Dr. Santelli teaches public health students about adolescent health and chairs the board of directors of the Sexuality Information and Education Council of the United States. He disclosed no financial conflicts.

American teenagers receive less formal sex education today than they did 25 years ago, with “troubling” racial inequities that leave youth of color and queer youth at greater risk than other teens for sexually transmitted diseases and unintended pregnancy, according to a new study.

“Many adolescents do not receive any instruction on essential topics or do not receive this instruction until after the first sex,” wrote Laura D. Lindberg, PhD, and Leslie M. Kantor, PhD, MPH, from the Guttmacher Institute, New York, and the department of urban-global public health at Rutgers University, Piscataway, N.J., respectively. “These gaps in sex education in the U.S. are uneven, and gender, racial, and other disparities are widespread,” they added, calling for “robust efforts ... to ensure equity and reduce health disparities.”

The study used cross-sectional data from the 2011-2015 and 2015-2019 National Surveys of Family Growth (NSFG) to examine content, timing, and location of formal sex education among 15- to 19-year-olds in the United States. The data came from samples of 2,047 females and 2,087 males in 2011-2015, and 1,894 females and 1,918 males in 2015-2019. The majority of respondents were aged 15-17 years and non-Hispanic White, with another quarter being Hispanic, and 14% Black.

The survey asked respondents whether, before they turned 18, they had ever received formal instruction at school, church, a community center, “or some other place” about how to say no to sex, methods of birth control, STDs, how to prevent HIV/AIDS, abstaining until marriage to have sex, where to get birth control, and how to use a condom.

Follow-up questions asked about what grade instruction was first received and whether it had occurred before first penile-vaginal intercourse. The 2015-2019 survey also asked about the location of instruction, but only concerning methods of birth control and abstinence until marriage.

The results showed that HIV and STD prevention was the most commonly reported area of instruction, received by more than 90% of both males and females. However, beyond this there were imbalances, with only about half (49%-55%) of respondents receiving instruction meeting the Surgeon General’s Healthy People 2030 composite sex education goal. Lack of instruction on birth control drove this result for 80% of respondents. Specifically, there was a strong slant emphasizing abstinence over birth control instruction. Over both survey periods and both genders, more respondents reported instruction on how to say no to sex (79%-84%) and abstaining until marriage (58%-73%), compared with where to obtain birth control (40%-53%) or how to use a condom (54%-60%). “Overall, about 20% of adolescents received instruction from multiple sources about waiting until marriage, but only 5%-8% received birth control information from multiple settings,” they reported.

There were racial/ethnic and sexual orientation differences in the scope and balance of instruction reported by teens. Less than half of Black (45%) and Hispanic (47%) males received instruction on the combined Healthy People topics, compared with 57% of White males. Black females were less likely (30%) than White females (45%) to receive information on where to get birth control before the first sex. Nonstraight males were less likely than straight males to receive instruction about STIs or HIV/AIDS (83% vs. 93%).

In addition, religious attendance emerged as a key factor in the receipt of sex education, “with more frequent religious attendance associated with a greater likelihood of instruction about delaying sex and less likelihood of instruction about contraception,” the authors noted.

Comparing their findings to previous NSFG surveys, the researchers commented that “the share of adolescents receiving instruction about birth control was higher in 1995 than in 2015-2019 for both the genders; in 1995, 87% of females and 81% of males reported sex education about birth control methods, compared with 64% and 63% in 2015-2019, respectively.” The findings “should spur policy makers at the national, state, and local levels to ensure the broader provision of sex education and that school districts serving young people of color are the focus of additional efforts and funding.”

Asked for comment, John Santelli, MD, MPH, professor of population and family health and pediatrics at Columbia University, New York, who was not involved with the study, said the findings fit into a series of studies by Lindberg going back to 1988 showing that receipt of formal sex education before age 18 has declined over time.

“We, the adults, in America can do better by our young people,” he said in an interview. “Adolescents need sex education that is science based, medically accurate, and developmentally appropriate. Many adolescents are not receiving education that the CDC and health professionals recommend including information about where to get birth control, condom skills, and even, how to say no to sex. The neglect of young Black and Hispanic men is very concerning. However, we are not doing a great job in educating most of our adolescents. Health care providers can be influential in speaking with parents about their children’s education about sex. We need to activate parents, health care providers, and members of the faith community to investigate what is happening about sex education in their own communities.”

Dr. Santelli noted that there are multiple ways to strengthen the provision of sex education in the United States. In a recent commentary, he and his coauthors highlighted the National Sex Education Standards (NSES), which, “developed in partnership between sex education organizations and health professionals, provide clear, consistent, and straightforward guidance on the essential content for students in grades K-12.” The NSES were also used in the development of the CDC’s recently released Health Education Curriculum Analysis Tool.

The commentary takes a strong stand against the recently released revised Medical Institute for Sexual Heath K-12 Standards for Optimal Sexual Development, which, compared with the NSES, are “seriously flawed from both scientific and human rights’ perspectives,” they wrote. “States and local communities aiming to improve adolescent sexual and reproductive health and looking for national standards on sex education should adopt the NSES.”

Dr. Lindberg and Dr. Kantor disclosed no conflicts of interest. Dr. Santelli teaches public health students about adolescent health and chairs the board of directors of the Sexuality Information and Education Council of the United States. He disclosed no financial conflicts.

American teenagers receive less formal sex education today than they did 25 years ago, with “troubling” racial inequities that leave youth of color and queer youth at greater risk than other teens for sexually transmitted diseases and unintended pregnancy, according to a new study.

“Many adolescents do not receive any instruction on essential topics or do not receive this instruction until after the first sex,” wrote Laura D. Lindberg, PhD, and Leslie M. Kantor, PhD, MPH, from the Guttmacher Institute, New York, and the department of urban-global public health at Rutgers University, Piscataway, N.J., respectively. “These gaps in sex education in the U.S. are uneven, and gender, racial, and other disparities are widespread,” they added, calling for “robust efforts ... to ensure equity and reduce health disparities.”

The study used cross-sectional data from the 2011-2015 and 2015-2019 National Surveys of Family Growth (NSFG) to examine content, timing, and location of formal sex education among 15- to 19-year-olds in the United States. The data came from samples of 2,047 females and 2,087 males in 2011-2015, and 1,894 females and 1,918 males in 2015-2019. The majority of respondents were aged 15-17 years and non-Hispanic White, with another quarter being Hispanic, and 14% Black.

The survey asked respondents whether, before they turned 18, they had ever received formal instruction at school, church, a community center, “or some other place” about how to say no to sex, methods of birth control, STDs, how to prevent HIV/AIDS, abstaining until marriage to have sex, where to get birth control, and how to use a condom.

Follow-up questions asked about what grade instruction was first received and whether it had occurred before first penile-vaginal intercourse. The 2015-2019 survey also asked about the location of instruction, but only concerning methods of birth control and abstinence until marriage.

The results showed that HIV and STD prevention was the most commonly reported area of instruction, received by more than 90% of both males and females. However, beyond this there were imbalances, with only about half (49%-55%) of respondents receiving instruction meeting the Surgeon General’s Healthy People 2030 composite sex education goal. Lack of instruction on birth control drove this result for 80% of respondents. Specifically, there was a strong slant emphasizing abstinence over birth control instruction. Over both survey periods and both genders, more respondents reported instruction on how to say no to sex (79%-84%) and abstaining until marriage (58%-73%), compared with where to obtain birth control (40%-53%) or how to use a condom (54%-60%). “Overall, about 20% of adolescents received instruction from multiple sources about waiting until marriage, but only 5%-8% received birth control information from multiple settings,” they reported.

There were racial/ethnic and sexual orientation differences in the scope and balance of instruction reported by teens. Less than half of Black (45%) and Hispanic (47%) males received instruction on the combined Healthy People topics, compared with 57% of White males. Black females were less likely (30%) than White females (45%) to receive information on where to get birth control before the first sex. Nonstraight males were less likely than straight males to receive instruction about STIs or HIV/AIDS (83% vs. 93%).

In addition, religious attendance emerged as a key factor in the receipt of sex education, “with more frequent religious attendance associated with a greater likelihood of instruction about delaying sex and less likelihood of instruction about contraception,” the authors noted.

Comparing their findings to previous NSFG surveys, the researchers commented that “the share of adolescents receiving instruction about birth control was higher in 1995 than in 2015-2019 for both the genders; in 1995, 87% of females and 81% of males reported sex education about birth control methods, compared with 64% and 63% in 2015-2019, respectively.” The findings “should spur policy makers at the national, state, and local levels to ensure the broader provision of sex education and that school districts serving young people of color are the focus of additional efforts and funding.”

Asked for comment, John Santelli, MD, MPH, professor of population and family health and pediatrics at Columbia University, New York, who was not involved with the study, said the findings fit into a series of studies by Lindberg going back to 1988 showing that receipt of formal sex education before age 18 has declined over time.

“We, the adults, in America can do better by our young people,” he said in an interview. “Adolescents need sex education that is science based, medically accurate, and developmentally appropriate. Many adolescents are not receiving education that the CDC and health professionals recommend including information about where to get birth control, condom skills, and even, how to say no to sex. The neglect of young Black and Hispanic men is very concerning. However, we are not doing a great job in educating most of our adolescents. Health care providers can be influential in speaking with parents about their children’s education about sex. We need to activate parents, health care providers, and members of the faith community to investigate what is happening about sex education in their own communities.”

Dr. Santelli noted that there are multiple ways to strengthen the provision of sex education in the United States. In a recent commentary, he and his coauthors highlighted the National Sex Education Standards (NSES), which, “developed in partnership between sex education organizations and health professionals, provide clear, consistent, and straightforward guidance on the essential content for students in grades K-12.” The NSES were also used in the development of the CDC’s recently released Health Education Curriculum Analysis Tool.

The commentary takes a strong stand against the recently released revised Medical Institute for Sexual Heath K-12 Standards for Optimal Sexual Development, which, compared with the NSES, are “seriously flawed from both scientific and human rights’ perspectives,” they wrote. “States and local communities aiming to improve adolescent sexual and reproductive health and looking for national standards on sex education should adopt the NSES.”

Dr. Lindberg and Dr. Kantor disclosed no conflicts of interest. Dr. Santelli teaches public health students about adolescent health and chairs the board of directors of the Sexuality Information and Education Council of the United States. He disclosed no financial conflicts.

Human papillomavirus (HPV) vaccination helps prevent cervical cancer and saves lives, new nationwide data suggest.

The analysis adds to a growing body of evidence demonstrating vaccine-associated changes in cervical cancer incidence and mortality.

Previous data from the United Kingdom, published earlier in November, showed that cervical cancer rates were 87% lower among girls who received the HPV vaccine compared to previously unvaccinated generations. Based on the analysis, the authors concluded that the UK’s HPV immunization program “almost eliminated cervical cancer” in women born since September 1995.

The latest study, published Nov. 29 in JAMA Pediatrics , reports a 38% drop in cervical cancer incidence and a 43% decline in mortality among young women and girls after HPV vaccination was introduced in the United States.

“These results are encouraging,” Peter Sasieni, MD, of King’s College London, and senior author on the U.K. study, told this news organization in an email.

The difference in incidence rates between the U.K. and U.S. studies, Dr. Sasieni explained, is likely due to HPV vaccine coverage not expanding as significantly in the United States as it has in the United Kingdom, and “thus one would anticipate a lower impact on the population in the U.S.”

In the U.S. analysis, Justin Barnes, MD, a radiation oncology resident at Washington University, St. Louis, and colleagues examined cervical cancer incidence between January 2001 and December 2017 using Surveillance, Epidemiology, and End Results and National Program of Cancer Registries data as well as mortality data from the National Center for Health Statistics.

Dr. Barnes and colleagues then compared changes in cervical cancer incidence and mortality between prevaccination years (January 2001 to December 2005) and postvaccination years (January 2010 to December 2017) among three age cohorts – 15-24 years, 25-29 years, and 30-39 years.

“The older 2 groups were included as comparison, given their low vaccination rates,” Dr. Barnes and colleagues explained.

Results show that between the prevaccination and postvaccination periods, the incidence of cervical cancer dropped by 38% in the youngest cohort and by only 16% in the middle-aged group and 8% in the oldest cohort.

Women and girls in the youngest group saw a striking drop in mortality: a 43% decline, which translated to a mortality rate of 0.6 per 100,000.

On the other hand, the authors report a 4.7% decline in mortality in the oldest group and a 4.3% increase in mortality in the middle-aged group – translating to a mortality rate of 1.89 per 100,000 and 0.57 per 100,000, respectively.

Overall, “these nationwide data showed decreased cervical cancer incidence and mortality among women and girls aged 15-24 years after HPV vaccine introduction,” Dr. Barnes and colleagues wrote. The changes in cervical cancer incidence and mortality observed in the youngest age group “were greater than changes in those aged 25 to 29 years and 30 to 39 years, suggesting possible associations with HPV vaccination.”

This analysis lines up with previous evidence from U.S. epidemiologic data, which “have shown decreased cervical cancer incidence after vaccine implementation in women and girls aged 15 to 24 years but not older women.”

Although “the number of deaths and hence the number of potentially averted deaths in young women and girls was small,” the study adds to the current literature by “providing suggestive evidence for vaccine-associated decreases in cervical cancer mortality,” investigators concluded.

The authors have disclosed no relevant financial relationships.

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

Human papillomavirus (HPV) vaccination helps prevent cervical cancer and saves lives, new nationwide data suggest.

The analysis adds to a growing body of evidence demonstrating vaccine-associated changes in cervical cancer incidence and mortality.

Previous data from the United Kingdom, published earlier in November, showed that cervical cancer rates were 87% lower among girls who received the HPV vaccine compared to previously unvaccinated generations. Based on the analysis, the authors concluded that the UK’s HPV immunization program “almost eliminated cervical cancer” in women born since September 1995.

The latest study, published Nov. 29 in JAMA Pediatrics , reports a 38% drop in cervical cancer incidence and a 43% decline in mortality among young women and girls after HPV vaccination was introduced in the United States.

“These results are encouraging,” Peter Sasieni, MD, of King’s College London, and senior author on the U.K. study, told this news organization in an email.

The difference in incidence rates between the U.K. and U.S. studies, Dr. Sasieni explained, is likely due to HPV vaccine coverage not expanding as significantly in the United States as it has in the United Kingdom, and “thus one would anticipate a lower impact on the population in the U.S.”

In the U.S. analysis, Justin Barnes, MD, a radiation oncology resident at Washington University, St. Louis, and colleagues examined cervical cancer incidence between January 2001 and December 2017 using Surveillance, Epidemiology, and End Results and National Program of Cancer Registries data as well as mortality data from the National Center for Health Statistics.

Dr. Barnes and colleagues then compared changes in cervical cancer incidence and mortality between prevaccination years (January 2001 to December 2005) and postvaccination years (January 2010 to December 2017) among three age cohorts – 15-24 years, 25-29 years, and 30-39 years.

“The older 2 groups were included as comparison, given their low vaccination rates,” Dr. Barnes and colleagues explained.

Results show that between the prevaccination and postvaccination periods, the incidence of cervical cancer dropped by 38% in the youngest cohort and by only 16% in the middle-aged group and 8% in the oldest cohort.

Women and girls in the youngest group saw a striking drop in mortality: a 43% decline, which translated to a mortality rate of 0.6 per 100,000.

On the other hand, the authors report a 4.7% decline in mortality in the oldest group and a 4.3% increase in mortality in the middle-aged group – translating to a mortality rate of 1.89 per 100,000 and 0.57 per 100,000, respectively.

Overall, “these nationwide data showed decreased cervical cancer incidence and mortality among women and girls aged 15-24 years after HPV vaccine introduction,” Dr. Barnes and colleagues wrote. The changes in cervical cancer incidence and mortality observed in the youngest age group “were greater than changes in those aged 25 to 29 years and 30 to 39 years, suggesting possible associations with HPV vaccination.”

This analysis lines up with previous evidence from U.S. epidemiologic data, which “have shown decreased cervical cancer incidence after vaccine implementation in women and girls aged 15 to 24 years but not older women.”

Although “the number of deaths and hence the number of potentially averted deaths in young women and girls was small,” the study adds to the current literature by “providing suggestive evidence for vaccine-associated decreases in cervical cancer mortality,” investigators concluded.

The authors have disclosed no relevant financial relationships.

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

Human papillomavirus (HPV) vaccination helps prevent cervical cancer and saves lives, new nationwide data suggest.

The analysis adds to a growing body of evidence demonstrating vaccine-associated changes in cervical cancer incidence and mortality.

Previous data from the United Kingdom, published earlier in November, showed that cervical cancer rates were 87% lower among girls who received the HPV vaccine compared to previously unvaccinated generations. Based on the analysis, the authors concluded that the UK’s HPV immunization program “almost eliminated cervical cancer” in women born since September 1995.

The latest study, published Nov. 29 in JAMA Pediatrics , reports a 38% drop in cervical cancer incidence and a 43% decline in mortality among young women and girls after HPV vaccination was introduced in the United States.

“These results are encouraging,” Peter Sasieni, MD, of King’s College London, and senior author on the U.K. study, told this news organization in an email.

The difference in incidence rates between the U.K. and U.S. studies, Dr. Sasieni explained, is likely due to HPV vaccine coverage not expanding as significantly in the United States as it has in the United Kingdom, and “thus one would anticipate a lower impact on the population in the U.S.”

In the U.S. analysis, Justin Barnes, MD, a radiation oncology resident at Washington University, St. Louis, and colleagues examined cervical cancer incidence between January 2001 and December 2017 using Surveillance, Epidemiology, and End Results and National Program of Cancer Registries data as well as mortality data from the National Center for Health Statistics.

Dr. Barnes and colleagues then compared changes in cervical cancer incidence and mortality between prevaccination years (January 2001 to December 2005) and postvaccination years (January 2010 to December 2017) among three age cohorts – 15-24 years, 25-29 years, and 30-39 years.

“The older 2 groups were included as comparison, given their low vaccination rates,” Dr. Barnes and colleagues explained.

Results show that between the prevaccination and postvaccination periods, the incidence of cervical cancer dropped by 38% in the youngest cohort and by only 16% in the middle-aged group and 8% in the oldest cohort.

Women and girls in the youngest group saw a striking drop in mortality: a 43% decline, which translated to a mortality rate of 0.6 per 100,000.

On the other hand, the authors report a 4.7% decline in mortality in the oldest group and a 4.3% increase in mortality in the middle-aged group – translating to a mortality rate of 1.89 per 100,000 and 0.57 per 100,000, respectively.

Overall, “these nationwide data showed decreased cervical cancer incidence and mortality among women and girls aged 15-24 years after HPV vaccine introduction,” Dr. Barnes and colleagues wrote. The changes in cervical cancer incidence and mortality observed in the youngest age group “were greater than changes in those aged 25 to 29 years and 30 to 39 years, suggesting possible associations with HPV vaccination.”

This analysis lines up with previous evidence from U.S. epidemiologic data, which “have shown decreased cervical cancer incidence after vaccine implementation in women and girls aged 15 to 24 years but not older women.”

Although “the number of deaths and hence the number of potentially averted deaths in young women and girls was small,” the study adds to the current literature by “providing suggestive evidence for vaccine-associated decreases in cervical cancer mortality,” investigators concluded.

The authors have disclosed no relevant financial relationships.

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

Gynecologists have experience managing human papillomavirus–associated diseases of the lower genital tract. However, HPV also causes warty disease, dysplasia, and carcinoma of the head and neck. Risk factors for head and neck cancer include smoking and smokeless tobacco use, alcohol consumption, periodontal disease, radiation exposure, and HPV. The incidence of HPV-associated head and neck cancer is rising, particularly among men, at a rate of 2.7% per year.¹ The incidence of HPV-associated squamous cell carcinoma of the oropharynx now surpasses that of cervical cancer. Concerns exist regarding occupational exposure to HPV by health care providers (HCP) who perform smoke-generating procedures on HPV-infected tissues, and the potential for them to develop head and neck pathology.

In March of 2020, the American Society for Colposcopy and Cervical Pathology made the recommendation that clinicians who are routinely exposed to HPV should protect themselves against the sequela of occupationally acquired HPV by receiving the HPV vaccine.² They advocate for the “complete provider team” including physicians, advanced practice providers, nurses, operative technicians, and residents and fellows to be considered for protective vaccination.

Similar to disease patterns in the genital tract, different strains of HPV have differing propensity to cause benign, premalignant, and malignant disease states. HPV 6 and 11 are more commonly associated with warty disease in the nares, pharynx, and tonsillar tissues. HPV 16, 18, 31, and 33 (most commonly 16) are considered high risk for carcinoma formation, particularly of the tonsils and base of the tongue.

The procedures most implicated in occupational HPV exposure include ablative procedures for anogenital warts, laser ablation of vaginal and vulvar dysplasia, and electrosurgical excisional procedures for cervical dysplasia. Smoke plumes from HPV-associated procedures are known to contain HPV for both laser and electrocautery sources.³ A study of 134 patients undergoing surgical procedures for laser ablation of HPV-infected tissues detected concordant strains of HPV in approximately 30% of smoke plumes and approximately 1.5% of surgeons’ nares.⁴ Not all procedures appear to carry the same risk. Electrocoagulation procedures appear to yield fewer postprocedural positive mucosal swabs for HPV, compared with those taken after CO₂ laser.⁵

Animal studies have shown that papilloma virus procured from smoke plume has the capacity to generate disease. When 10 calves were inoculated with bovine papillary virus obtained from smoke plumes from laser ablation of bovine papillomavirus lesions, all calves manifested BPV fibropapilloma lesions at the sites of inoculation.⁶

There appears to be an increased incidence of HPV-associated head and neck disease among surgeons who perform procedures on HPV tissues, and there have been multiple case reports that have cited examples of HPV-associated benign and malignant disease among HCPs with frequent occupational exposure to HPV anogenital ablative and excisional procedures.⁷ While these observations are not proof of causation, they are cause for concern.

While the ASCCP guidelines advocate for HPV vaccination as a strategy for prevention of occupationally related HPV-associated disease, there are other strategies in place to minimize risk. The CDC guidelines for environmental infection control in health care facilities include the following recommendations:

• In settings where surgical lasers are used, wear appropriate personnel protective equipment (PPE), including N95 or N100 respirators to minimize exposure to laser plumes.
• Use central wall suction units with in-line filters to evacuate minimal laser plumes.
• Use a mechanical smoke evaluation system with a high efficiency filter to manage the generation of large amounts of laser plume, when ablating tissue infected with HPV.
• Use local exhaust ventilation (LEV).⁸

When closely adhered to, these methods appear to provide high-level protection. Data suggest that, when HCPs can access appropriate protective equipment, risks for HPV exposure are low. However, this is more feasible for larger hospital facilities, and may be more limited in outpatient settings. This has led to the consideration of background protection in the form of HPV vaccination for at-risk HCPs. This is analogous to mandates for HCPs to receive hepatitis B vaccination despite the concomitant practice of universal precautions in health care settings. Preventative strategies are typically most efficacious when performed in concert.

After nearly 2 decades of widespread use, we have confidence in the safety of the HPV vaccination. Its benefit through age 45 has been established, leading to the 2018 FDA approval for the 9-valent HPV vaccine, Guardisil-9, for this expanded age group. It would seem logical that systematic administration of the HPV vaccine for at-risk HCPs would be both feasible and safe. There are well-established systems for administering vaccines for HCPs in all health care systems. Perhaps health system administrators should consider routinely offering HPV vaccination for at-risk employees as part of their occupational health care responsibilities. One important caveat being the cost and efficacy of HPV vaccination in this group has not been not established.

In the meantime, it is critical that gynecology providers be aware of their risk for occupational exposure to HPV when using laser and electrocautery techniques on HPV-infected tissues and the potential for them developing head and neck pathology. They should strictly adhere to preventative measures such as use of fit-tested N-95 respirators, mechanical smoke evacuators with high-efficiency filters and work in environments with adequate room ventilation. We all should individually evaluate what role HPV vaccination may play for us in augmenting our own safety.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Van Dyne EA et al. MMWR Morb Mortal Wkly Rep. 2018 Aug 24;67(33):918-24.

2. ASCCP. ASCCP recommends HPV vaccination for providers.

3. Fox-Lewis A et al. Occup Environ Med. 2020 Dec;77(12):809-17.

4. Zhou Q et al. Cancer Manag Res. 2019;11:3643-54

5. Bergbrant I et al. Acta Derm Venereol. 1994 Sep;74(5):393-5.

6. Garden J et al. Arch Dermatol. 2002 Oct;138(10):1303-7.

7. Harrison R, Huh W. Obstet Gynecol. 2020;136:663-5.

8. CDC. 1996. DHHS (NIOSH) Publication Number 96-128.

Gynecologists have experience managing human papillomavirus–associated diseases of the lower genital tract. However, HPV also causes warty disease, dysplasia, and carcinoma of the head and neck. Risk factors for head and neck cancer include smoking and smokeless tobacco use, alcohol consumption, periodontal disease, radiation exposure, and HPV. The incidence of HPV-associated head and neck cancer is rising, particularly among men, at a rate of 2.7% per year.¹ The incidence of HPV-associated squamous cell carcinoma of the oropharynx now surpasses that of cervical cancer. Concerns exist regarding occupational exposure to HPV by health care providers (HCP) who perform smoke-generating procedures on HPV-infected tissues, and the potential for them to develop head and neck pathology.

In March of 2020, the American Society for Colposcopy and Cervical Pathology made the recommendation that clinicians who are routinely exposed to HPV should protect themselves against the sequela of occupationally acquired HPV by receiving the HPV vaccine.² They advocate for the “complete provider team” including physicians, advanced practice providers, nurses, operative technicians, and residents and fellows to be considered for protective vaccination.

Similar to disease patterns in the genital tract, different strains of HPV have differing propensity to cause benign, premalignant, and malignant disease states. HPV 6 and 11 are more commonly associated with warty disease in the nares, pharynx, and tonsillar tissues. HPV 16, 18, 31, and 33 (most commonly 16) are considered high risk for carcinoma formation, particularly of the tonsils and base of the tongue.

The procedures most implicated in occupational HPV exposure include ablative procedures for anogenital warts, laser ablation of vaginal and vulvar dysplasia, and electrosurgical excisional procedures for cervical dysplasia. Smoke plumes from HPV-associated procedures are known to contain HPV for both laser and electrocautery sources.³ A study of 134 patients undergoing surgical procedures for laser ablation of HPV-infected tissues detected concordant strains of HPV in approximately 30% of smoke plumes and approximately 1.5% of surgeons’ nares.⁴ Not all procedures appear to carry the same risk. Electrocoagulation procedures appear to yield fewer postprocedural positive mucosal swabs for HPV, compared with those taken after CO₂ laser.⁵

Animal studies have shown that papilloma virus procured from smoke plume has the capacity to generate disease. When 10 calves were inoculated with bovine papillary virus obtained from smoke plumes from laser ablation of bovine papillomavirus lesions, all calves manifested BPV fibropapilloma lesions at the sites of inoculation.⁶

There appears to be an increased incidence of HPV-associated head and neck disease among surgeons who perform procedures on HPV tissues, and there have been multiple case reports that have cited examples of HPV-associated benign and malignant disease among HCPs with frequent occupational exposure to HPV anogenital ablative and excisional procedures.⁷ While these observations are not proof of causation, they are cause for concern.

While the ASCCP guidelines advocate for HPV vaccination as a strategy for prevention of occupationally related HPV-associated disease, there are other strategies in place to minimize risk. The CDC guidelines for environmental infection control in health care facilities include the following recommendations:

• In settings where surgical lasers are used, wear appropriate personnel protective equipment (PPE), including N95 or N100 respirators to minimize exposure to laser plumes.
• Use central wall suction units with in-line filters to evacuate minimal laser plumes.
• Use a mechanical smoke evaluation system with a high efficiency filter to manage the generation of large amounts of laser plume, when ablating tissue infected with HPV.
• Use local exhaust ventilation (LEV).⁸

When closely adhered to, these methods appear to provide high-level protection. Data suggest that, when HCPs can access appropriate protective equipment, risks for HPV exposure are low. However, this is more feasible for larger hospital facilities, and may be more limited in outpatient settings. This has led to the consideration of background protection in the form of HPV vaccination for at-risk HCPs. This is analogous to mandates for HCPs to receive hepatitis B vaccination despite the concomitant practice of universal precautions in health care settings. Preventative strategies are typically most efficacious when performed in concert.

After nearly 2 decades of widespread use, we have confidence in the safety of the HPV vaccination. Its benefit through age 45 has been established, leading to the 2018 FDA approval for the 9-valent HPV vaccine, Guardisil-9, for this expanded age group. It would seem logical that systematic administration of the HPV vaccine for at-risk HCPs would be both feasible and safe. There are well-established systems for administering vaccines for HCPs in all health care systems. Perhaps health system administrators should consider routinely offering HPV vaccination for at-risk employees as part of their occupational health care responsibilities. One important caveat being the cost and efficacy of HPV vaccination in this group has not been not established.

In the meantime, it is critical that gynecology providers be aware of their risk for occupational exposure to HPV when using laser and electrocautery techniques on HPV-infected tissues and the potential for them developing head and neck pathology. They should strictly adhere to preventative measures such as use of fit-tested N-95 respirators, mechanical smoke evacuators with high-efficiency filters and work in environments with adequate room ventilation. We all should individually evaluate what role HPV vaccination may play for us in augmenting our own safety.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Van Dyne EA et al. MMWR Morb Mortal Wkly Rep. 2018 Aug 24;67(33):918-24.

2. ASCCP. ASCCP recommends HPV vaccination for providers.

3. Fox-Lewis A et al. Occup Environ Med. 2020 Dec;77(12):809-17.

4. Zhou Q et al. Cancer Manag Res. 2019;11:3643-54

5. Bergbrant I et al. Acta Derm Venereol. 1994 Sep;74(5):393-5.

6. Garden J et al. Arch Dermatol. 2002 Oct;138(10):1303-7.

7. Harrison R, Huh W. Obstet Gynecol. 2020;136:663-5.

8. CDC. 1996. DHHS (NIOSH) Publication Number 96-128.

Gynecologists have experience managing human papillomavirus–associated diseases of the lower genital tract. However, HPV also causes warty disease, dysplasia, and carcinoma of the head and neck. Risk factors for head and neck cancer include smoking and smokeless tobacco use, alcohol consumption, periodontal disease, radiation exposure, and HPV. The incidence of HPV-associated head and neck cancer is rising, particularly among men, at a rate of 2.7% per year.¹ The incidence of HPV-associated squamous cell carcinoma of the oropharynx now surpasses that of cervical cancer. Concerns exist regarding occupational exposure to HPV by health care providers (HCP) who perform smoke-generating procedures on HPV-infected tissues, and the potential for them to develop head and neck pathology.

In March of 2020, the American Society for Colposcopy and Cervical Pathology made the recommendation that clinicians who are routinely exposed to HPV should protect themselves against the sequela of occupationally acquired HPV by receiving the HPV vaccine.² They advocate for the “complete provider team” including physicians, advanced practice providers, nurses, operative technicians, and residents and fellows to be considered for protective vaccination.

Similar to disease patterns in the genital tract, different strains of HPV have differing propensity to cause benign, premalignant, and malignant disease states. HPV 6 and 11 are more commonly associated with warty disease in the nares, pharynx, and tonsillar tissues. HPV 16, 18, 31, and 33 (most commonly 16) are considered high risk for carcinoma formation, particularly of the tonsils and base of the tongue.

The procedures most implicated in occupational HPV exposure include ablative procedures for anogenital warts, laser ablation of vaginal and vulvar dysplasia, and electrosurgical excisional procedures for cervical dysplasia. Smoke plumes from HPV-associated procedures are known to contain HPV for both laser and electrocautery sources.³ A study of 134 patients undergoing surgical procedures for laser ablation of HPV-infected tissues detected concordant strains of HPV in approximately 30% of smoke plumes and approximately 1.5% of surgeons’ nares.⁴ Not all procedures appear to carry the same risk. Electrocoagulation procedures appear to yield fewer postprocedural positive mucosal swabs for HPV, compared with those taken after CO₂ laser.⁵

Animal studies have shown that papilloma virus procured from smoke plume has the capacity to generate disease. When 10 calves were inoculated with bovine papillary virus obtained from smoke plumes from laser ablation of bovine papillomavirus lesions, all calves manifested BPV fibropapilloma lesions at the sites of inoculation.⁶

There appears to be an increased incidence of HPV-associated head and neck disease among surgeons who perform procedures on HPV tissues, and there have been multiple case reports that have cited examples of HPV-associated benign and malignant disease among HCPs with frequent occupational exposure to HPV anogenital ablative and excisional procedures.⁷ While these observations are not proof of causation, they are cause for concern.

While the ASCCP guidelines advocate for HPV vaccination as a strategy for prevention of occupationally related HPV-associated disease, there are other strategies in place to minimize risk. The CDC guidelines for environmental infection control in health care facilities include the following recommendations:

• In settings where surgical lasers are used, wear appropriate personnel protective equipment (PPE), including N95 or N100 respirators to minimize exposure to laser plumes.
• Use central wall suction units with in-line filters to evacuate minimal laser plumes.
• Use a mechanical smoke evaluation system with a high efficiency filter to manage the generation of large amounts of laser plume, when ablating tissue infected with HPV.
• Use local exhaust ventilation (LEV).⁸

When closely adhered to, these methods appear to provide high-level protection. Data suggest that, when HCPs can access appropriate protective equipment, risks for HPV exposure are low. However, this is more feasible for larger hospital facilities, and may be more limited in outpatient settings. This has led to the consideration of background protection in the form of HPV vaccination for at-risk HCPs. This is analogous to mandates for HCPs to receive hepatitis B vaccination despite the concomitant practice of universal precautions in health care settings. Preventative strategies are typically most efficacious when performed in concert.

After nearly 2 decades of widespread use, we have confidence in the safety of the HPV vaccination. Its benefit through age 45 has been established, leading to the 2018 FDA approval for the 9-valent HPV vaccine, Guardisil-9, for this expanded age group. It would seem logical that systematic administration of the HPV vaccine for at-risk HCPs would be both feasible and safe. There are well-established systems for administering vaccines for HCPs in all health care systems. Perhaps health system administrators should consider routinely offering HPV vaccination for at-risk employees as part of their occupational health care responsibilities. One important caveat being the cost and efficacy of HPV vaccination in this group has not been not established.

In the meantime, it is critical that gynecology providers be aware of their risk for occupational exposure to HPV when using laser and electrocautery techniques on HPV-infected tissues and the potential for them developing head and neck pathology. They should strictly adhere to preventative measures such as use of fit-tested N-95 respirators, mechanical smoke evacuators with high-efficiency filters and work in environments with adequate room ventilation. We all should individually evaluate what role HPV vaccination may play for us in augmenting our own safety.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill.

References

1. Van Dyne EA et al. MMWR Morb Mortal Wkly Rep. 2018 Aug 24;67(33):918-24.

2. ASCCP. ASCCP recommends HPV vaccination for providers.

3. Fox-Lewis A et al. Occup Environ Med. 2020 Dec;77(12):809-17.

4. Zhou Q et al. Cancer Manag Res. 2019;11:3643-54

5. Bergbrant I et al. Acta Derm Venereol. 1994 Sep;74(5):393-5.

6. Garden J et al. Arch Dermatol. 2002 Oct;138(10):1303-7.

7. Harrison R, Huh W. Obstet Gynecol. 2020;136:663-5.

8. CDC. 1996. DHHS (NIOSH) Publication Number 96-128.

Women whose ovaries were surgically removed before the age of 46 had a higher risk of mild cognitive impairment (MCI) around 30 years later, compared with those who did not undergo bilateral oophorectomy, according to a population-based linkage study published in JAMA Network Open.

The findings suggest that “physicians treating women with premenopausal bilateral oophorectomy need to be aware of their patients’ risk of cognitive impairment or MCI and should consider implementing treatment-monitoring plans,” noted lead author Walter A. Rocca, MD, MPH, from the division of epidemiology, department of quantitative health sciences, at the Mayo Clinic, Rochester, Minn. and colleagues.

The results may particularly “help women at mean risk levels of ovarian cancer to better evaluate the risk-to-benefit ratio of undergoing bilateral oophorectomy prior to spontaneous menopause for the prevention of ovarian cancer,” they emphasized.

While the link between premenopausal bilateral oophorectomy and higher risk of cognitive impairment has been previously suggested, this new study “contributes valuable new data to a major public health importance issue and addresses a number of important shortcomings of existing literature,” Marios K. Georgakis, MD, PhD, and Eleni T. Petridou, MD, PhD, noted in an accompanying commentary.

“As bilateral oophorectomy is still a common procedure at least in well-resourced countries, the results of these studies should alert clinicians about its potential public health consequences. Given that the abrupt cessation of ovarian hormones might be accompanied by previously underestimated long-term adverse effects, treating physicians proposing the operation should weigh its benefits against potential long-term harmful effects, especially among women without an absolute indication,” noted Dr. Georgakis and Dr. Petridou, respectively from the Center for Genomic Medicine at Massachusetts General Hospital in Boston and the National and Kapodistrian University of Athens.

The case-control cross-sectional study used data from the Mayo Clinic Study of Aging (MCSA), a prospective, population-based study examining risk factors for, as well as prevalence and incidence of cognitive decline and MCI among a representative sample of women in Olmsted County, Minn. It included 2,732 women aged 50-89 years who participated in the MCSA study from 2004 to 2019 and underwent a clinical evaluation and comprehensive cognitive testing including nine tests covering four cognitive domains. Almost all of the subjects (98.4%) were White. The mean age of cognitive evaluation was 74 years – at which time 283 women (10.4%) were diagnosed with MCI (197 with amnestic and 86 with nonamnestic MCI). Data from the Rochester Epidemiology Project medical record–linkage system showed a total of 625 women (22.9%) had a history of bilateral oophorectomy. Among this group, 161 women underwent the procedure both before age 46, and before menopause, with 46 (28.6%) receiving oral conjugated equine estrogen (unopposed) and the remaining 95 (59.0%) receiving no estrogen therapy.

The study found that, compared with women who did not undergo bilateral oophorectomy, those who did so before age 46, but not after this age, had statistically significantly increased odds of MCI (adjusted odds ratio, 2.21; P < .001). When type of MCI was examined, the risk was statistically significant for nonamnestic MCI (aOR, 2.96; P < .001), and amnestic (aOR, 1.87; P =.03). The study also found no evidence that estrogen therapy was associated with decreased risk of MCI among women aged less than 46 years, with an aOR of 2.56 in those who received estrogen therapy and 2.05 in those who did not (P = .01 for both).

Finally, in women who had bilateral oophorectomy before menopause and before age 50, surgical indication for the procedure affected the association with MCI. Indications of either cancer or “no ovarian condition” (i.e., performed at the time of hysterectomy) were associated with no increased risk, whereas there was a statistically significantly increased risk associated with benign indications such as an adnexal mass, cyst or endometriosis (aOR, 2.43; P = .003). “This is important,” noted the commentators, “because in many of those cases removal of both ovaries could be avoided.”

The study also found that, compared with women who had not undergone bilateral oophorectomy, those who had also had increased frequency of cardiovascular risk factors, heart disease, and stroke at the time of their cognitive evaluation. “Additional research is needed to clarify the biological explanation of the association,” the investigators said.

The prevailing hypothesis for why premenopausal bilateral oophorectomy is associated with cognitive decline “is that the abrupt endocrine cessation of exposure to ovarian hormones accelerates the aging process,” the commentators noted. “Most important from a clinical perspective is whether these women would benefit from specific hormone replacement therapy schemes. Observational studies cannot reliably answer this question, and possibly it is time to rethink designing trials in specific groups of women who underwent bilateral oophorectomy before 46 years of age starting treatment immediately thereafter.”

In an interview Dr. Georgakis elaborated on this point, saying that, while the Women’s Health Study clearly showed no benefit of hormone replacement therapy for preventing dementia, it recruited women who were aged 65 years or older and had therefore undergone menopause more than 10-15 years earlier. “A hypothesis suggests that a critical vulnerability window exists shortly after menopause during which hormone replacement therapy might be needed to ameliorate any elevated risk,” he said. “Thus, it might make sense to reconsider a trial focused on this group of premenopausal women, who need to undergo oophorectomy at a young age (<46 years). Early initiation would be important. Unfortunately, such a trial would be difficult to conduct, because these women would need to be followed up for very long periods, as cognitive decline usually does not occur before the age of 65.”

Asked to comment on the study, Meadow Good, DO, an ob.gyn., female pelvic medicine and reconstructive surgeon, and physician adviser for Winnie Palmer Hospital for Women & Babies in Orlando, said this study adds credibility to previous studies showing the cognitive risk associated with premenopausal bilateral oophorectomy. “The literature is now pointing to a need to refrain from elective bilateral oophorectomy in women less than 60,” she said in an interview. “It should not be common that a women receives a bilateral oophorectomy before 60 for benign reasons.”

She added that cognition is not the only think at stake. “Bilateral oophorectomy before the age of 60 has a higher risk of incident heart disease, stroke, lung cancer and total cancers,” she said, citing a prospective cohort study within the Nurses’ Health Study.

Dr. Rocca reported financial support from the Mayo Clinic Research Committee during the conduct of the study. One coauthor reported unrestricted grants from Biogen and consulting fees from Brain Protection outside the submitted work. No other disclosures were reported from the authors. Dr. Georgakis, Dr. Petridou, and Dr. Good reported no conflicts of interest. The study was funded by the National Institute on Aging. It also used resources of the Rochester Epidemiology Project medical record–linkage system, which is supported by the NIA, the Mayo Clinic Research Committee, and user fees. Dr. Rocca was partly funded by the Ralph S. and Beverley E. Caulkins Professorship of Neurodegenerative Diseases Research of the Mayo Clinic.

Women whose ovaries were surgically removed before the age of 46 had a higher risk of mild cognitive impairment (MCI) around 30 years later, compared with those who did not undergo bilateral oophorectomy, according to a population-based linkage study published in JAMA Network Open.

The findings suggest that “physicians treating women with premenopausal bilateral oophorectomy need to be aware of their patients’ risk of cognitive impairment or MCI and should consider implementing treatment-monitoring plans,” noted lead author Walter A. Rocca, MD, MPH, from the division of epidemiology, department of quantitative health sciences, at the Mayo Clinic, Rochester, Minn. and colleagues.

The results may particularly “help women at mean risk levels of ovarian cancer to better evaluate the risk-to-benefit ratio of undergoing bilateral oophorectomy prior to spontaneous menopause for the prevention of ovarian cancer,” they emphasized.

While the link between premenopausal bilateral oophorectomy and higher risk of cognitive impairment has been previously suggested, this new study “contributes valuable new data to a major public health importance issue and addresses a number of important shortcomings of existing literature,” Marios K. Georgakis, MD, PhD, and Eleni T. Petridou, MD, PhD, noted in an accompanying commentary.

“As bilateral oophorectomy is still a common procedure at least in well-resourced countries, the results of these studies should alert clinicians about its potential public health consequences. Given that the abrupt cessation of ovarian hormones might be accompanied by previously underestimated long-term adverse effects, treating physicians proposing the operation should weigh its benefits against potential long-term harmful effects, especially among women without an absolute indication,” noted Dr. Georgakis and Dr. Petridou, respectively from the Center for Genomic Medicine at Massachusetts General Hospital in Boston and the National and Kapodistrian University of Athens.

The case-control cross-sectional study used data from the Mayo Clinic Study of Aging (MCSA), a prospective, population-based study examining risk factors for, as well as prevalence and incidence of cognitive decline and MCI among a representative sample of women in Olmsted County, Minn. It included 2,732 women aged 50-89 years who participated in the MCSA study from 2004 to 2019 and underwent a clinical evaluation and comprehensive cognitive testing including nine tests covering four cognitive domains. Almost all of the subjects (98.4%) were White. The mean age of cognitive evaluation was 74 years – at which time 283 women (10.4%) were diagnosed with MCI (197 with amnestic and 86 with nonamnestic MCI). Data from the Rochester Epidemiology Project medical record–linkage system showed a total of 625 women (22.9%) had a history of bilateral oophorectomy. Among this group, 161 women underwent the procedure both before age 46, and before menopause, with 46 (28.6%) receiving oral conjugated equine estrogen (unopposed) and the remaining 95 (59.0%) receiving no estrogen therapy.

The study found that, compared with women who did not undergo bilateral oophorectomy, those who did so before age 46, but not after this age, had statistically significantly increased odds of MCI (adjusted odds ratio, 2.21; P < .001). When type of MCI was examined, the risk was statistically significant for nonamnestic MCI (aOR, 2.96; P < .001), and amnestic (aOR, 1.87; P =.03). The study also found no evidence that estrogen therapy was associated with decreased risk of MCI among women aged less than 46 years, with an aOR of 2.56 in those who received estrogen therapy and 2.05 in those who did not (P = .01 for both).

Finally, in women who had bilateral oophorectomy before menopause and before age 50, surgical indication for the procedure affected the association with MCI. Indications of either cancer or “no ovarian condition” (i.e., performed at the time of hysterectomy) were associated with no increased risk, whereas there was a statistically significantly increased risk associated with benign indications such as an adnexal mass, cyst or endometriosis (aOR, 2.43; P = .003). “This is important,” noted the commentators, “because in many of those cases removal of both ovaries could be avoided.”

The study also found that, compared with women who had not undergone bilateral oophorectomy, those who had also had increased frequency of cardiovascular risk factors, heart disease, and stroke at the time of their cognitive evaluation. “Additional research is needed to clarify the biological explanation of the association,” the investigators said.

The prevailing hypothesis for why premenopausal bilateral oophorectomy is associated with cognitive decline “is that the abrupt endocrine cessation of exposure to ovarian hormones accelerates the aging process,” the commentators noted. “Most important from a clinical perspective is whether these women would benefit from specific hormone replacement therapy schemes. Observational studies cannot reliably answer this question, and possibly it is time to rethink designing trials in specific groups of women who underwent bilateral oophorectomy before 46 years of age starting treatment immediately thereafter.”

In an interview Dr. Georgakis elaborated on this point, saying that, while the Women’s Health Study clearly showed no benefit of hormone replacement therapy for preventing dementia, it recruited women who were aged 65 years or older and had therefore undergone menopause more than 10-15 years earlier. “A hypothesis suggests that a critical vulnerability window exists shortly after menopause during which hormone replacement therapy might be needed to ameliorate any elevated risk,” he said. “Thus, it might make sense to reconsider a trial focused on this group of premenopausal women, who need to undergo oophorectomy at a young age (<46 years). Early initiation would be important. Unfortunately, such a trial would be difficult to conduct, because these women would need to be followed up for very long periods, as cognitive decline usually does not occur before the age of 65.”

Asked to comment on the study, Meadow Good, DO, an ob.gyn., female pelvic medicine and reconstructive surgeon, and physician adviser for Winnie Palmer Hospital for Women & Babies in Orlando, said this study adds credibility to previous studies showing the cognitive risk associated with premenopausal bilateral oophorectomy. “The literature is now pointing to a need to refrain from elective bilateral oophorectomy in women less than 60,” she said in an interview. “It should not be common that a women receives a bilateral oophorectomy before 60 for benign reasons.”

She added that cognition is not the only think at stake. “Bilateral oophorectomy before the age of 60 has a higher risk of incident heart disease, stroke, lung cancer and total cancers,” she said, citing a prospective cohort study within the Nurses’ Health Study.

Dr. Rocca reported financial support from the Mayo Clinic Research Committee during the conduct of the study. One coauthor reported unrestricted grants from Biogen and consulting fees from Brain Protection outside the submitted work. No other disclosures were reported from the authors. Dr. Georgakis, Dr. Petridou, and Dr. Good reported no conflicts of interest. The study was funded by the National Institute on Aging. It also used resources of the Rochester Epidemiology Project medical record–linkage system, which is supported by the NIA, the Mayo Clinic Research Committee, and user fees. Dr. Rocca was partly funded by the Ralph S. and Beverley E. Caulkins Professorship of Neurodegenerative Diseases Research of the Mayo Clinic.

Women whose ovaries were surgically removed before the age of 46 had a higher risk of mild cognitive impairment (MCI) around 30 years later, compared with those who did not undergo bilateral oophorectomy, according to a population-based linkage study published in JAMA Network Open.

The findings suggest that “physicians treating women with premenopausal bilateral oophorectomy need to be aware of their patients’ risk of cognitive impairment or MCI and should consider implementing treatment-monitoring plans,” noted lead author Walter A. Rocca, MD, MPH, from the division of epidemiology, department of quantitative health sciences, at the Mayo Clinic, Rochester, Minn. and colleagues.

The results may particularly “help women at mean risk levels of ovarian cancer to better evaluate the risk-to-benefit ratio of undergoing bilateral oophorectomy prior to spontaneous menopause for the prevention of ovarian cancer,” they emphasized.

While the link between premenopausal bilateral oophorectomy and higher risk of cognitive impairment has been previously suggested, this new study “contributes valuable new data to a major public health importance issue and addresses a number of important shortcomings of existing literature,” Marios K. Georgakis, MD, PhD, and Eleni T. Petridou, MD, PhD, noted in an accompanying commentary.

“As bilateral oophorectomy is still a common procedure at least in well-resourced countries, the results of these studies should alert clinicians about its potential public health consequences. Given that the abrupt cessation of ovarian hormones might be accompanied by previously underestimated long-term adverse effects, treating physicians proposing the operation should weigh its benefits against potential long-term harmful effects, especially among women without an absolute indication,” noted Dr. Georgakis and Dr. Petridou, respectively from the Center for Genomic Medicine at Massachusetts General Hospital in Boston and the National and Kapodistrian University of Athens.

The case-control cross-sectional study used data from the Mayo Clinic Study of Aging (MCSA), a prospective, population-based study examining risk factors for, as well as prevalence and incidence of cognitive decline and MCI among a representative sample of women in Olmsted County, Minn. It included 2,732 women aged 50-89 years who participated in the MCSA study from 2004 to 2019 and underwent a clinical evaluation and comprehensive cognitive testing including nine tests covering four cognitive domains. Almost all of the subjects (98.4%) were White. The mean age of cognitive evaluation was 74 years – at which time 283 women (10.4%) were diagnosed with MCI (197 with amnestic and 86 with nonamnestic MCI). Data from the Rochester Epidemiology Project medical record–linkage system showed a total of 625 women (22.9%) had a history of bilateral oophorectomy. Among this group, 161 women underwent the procedure both before age 46, and before menopause, with 46 (28.6%) receiving oral conjugated equine estrogen (unopposed) and the remaining 95 (59.0%) receiving no estrogen therapy.

The study found that, compared with women who did not undergo bilateral oophorectomy, those who did so before age 46, but not after this age, had statistically significantly increased odds of MCI (adjusted odds ratio, 2.21; P < .001). When type of MCI was examined, the risk was statistically significant for nonamnestic MCI (aOR, 2.96; P < .001), and amnestic (aOR, 1.87; P =.03). The study also found no evidence that estrogen therapy was associated with decreased risk of MCI among women aged less than 46 years, with an aOR of 2.56 in those who received estrogen therapy and 2.05 in those who did not (P = .01 for both).

Finally, in women who had bilateral oophorectomy before menopause and before age 50, surgical indication for the procedure affected the association with MCI. Indications of either cancer or “no ovarian condition” (i.e., performed at the time of hysterectomy) were associated with no increased risk, whereas there was a statistically significantly increased risk associated with benign indications such as an adnexal mass, cyst or endometriosis (aOR, 2.43; P = .003). “This is important,” noted the commentators, “because in many of those cases removal of both ovaries could be avoided.”

The study also found that, compared with women who had not undergone bilateral oophorectomy, those who had also had increased frequency of cardiovascular risk factors, heart disease, and stroke at the time of their cognitive evaluation. “Additional research is needed to clarify the biological explanation of the association,” the investigators said.

The prevailing hypothesis for why premenopausal bilateral oophorectomy is associated with cognitive decline “is that the abrupt endocrine cessation of exposure to ovarian hormones accelerates the aging process,” the commentators noted. “Most important from a clinical perspective is whether these women would benefit from specific hormone replacement therapy schemes. Observational studies cannot reliably answer this question, and possibly it is time to rethink designing trials in specific groups of women who underwent bilateral oophorectomy before 46 years of age starting treatment immediately thereafter.”

In an interview Dr. Georgakis elaborated on this point, saying that, while the Women’s Health Study clearly showed no benefit of hormone replacement therapy for preventing dementia, it recruited women who were aged 65 years or older and had therefore undergone menopause more than 10-15 years earlier. “A hypothesis suggests that a critical vulnerability window exists shortly after menopause during which hormone replacement therapy might be needed to ameliorate any elevated risk,” he said. “Thus, it might make sense to reconsider a trial focused on this group of premenopausal women, who need to undergo oophorectomy at a young age (<46 years). Early initiation would be important. Unfortunately, such a trial would be difficult to conduct, because these women would need to be followed up for very long periods, as cognitive decline usually does not occur before the age of 65.”

Asked to comment on the study, Meadow Good, DO, an ob.gyn., female pelvic medicine and reconstructive surgeon, and physician adviser for Winnie Palmer Hospital for Women & Babies in Orlando, said this study adds credibility to previous studies showing the cognitive risk associated with premenopausal bilateral oophorectomy. “The literature is now pointing to a need to refrain from elective bilateral oophorectomy in women less than 60,” she said in an interview. “It should not be common that a women receives a bilateral oophorectomy before 60 for benign reasons.”

She added that cognition is not the only think at stake. “Bilateral oophorectomy before the age of 60 has a higher risk of incident heart disease, stroke, lung cancer and total cancers,” she said, citing a prospective cohort study within the Nurses’ Health Study.

Dr. Rocca reported financial support from the Mayo Clinic Research Committee during the conduct of the study. One coauthor reported unrestricted grants from Biogen and consulting fees from Brain Protection outside the submitted work. No other disclosures were reported from the authors. Dr. Georgakis, Dr. Petridou, and Dr. Good reported no conflicts of interest. The study was funded by the National Institute on Aging. It also used resources of the Rochester Epidemiology Project medical record–linkage system, which is supported by the NIA, the Mayo Clinic Research Committee, and user fees. Dr. Rocca was partly funded by the Ralph S. and Beverley E. Caulkins Professorship of Neurodegenerative Diseases Research of the Mayo Clinic.

SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.

Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.

Abortion clinics are already girding themselves for a surge in demand.

Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.

While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.

She is adding staff members and appointment capacity, hoping to accommodate everyone.

“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.

The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.

Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.

Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.

In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.

Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.

In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.

Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.

The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.

Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.

The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.

It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.

California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.

A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.

One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.

Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.

Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.

The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.

One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.

Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.

Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.

Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.

Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.

But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.

“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.

Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.

Abortion clinics are already girding themselves for a surge in demand.

Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.

While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.

She is adding staff members and appointment capacity, hoping to accommodate everyone.

“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.

The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.

Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.

Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.

In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.

Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.

In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.

Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.

The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.

Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.

The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.

It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.

California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.

A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.

One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.

Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.

Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.

The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.

One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.

Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.

Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.

Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.

Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.

But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.

“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO – With access to abortion at stake across America, California is preparing to become the nation’s abortion provider.

Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January.

Abortion clinics are already girding themselves for a surge in demand.

Janet Jacobson, MD, medical director of Planned Parenthood of Orange and San Bernardino Counties, said three or four out-of-state patients visit her clinics each day – about double the number that sought treatment before a near-total ban on abortion took effect in Texas in September.

While the nine clinics can absorb that slow trickle, they expect up to 50 out-of-state patients a week if the U.S. Supreme Court’s conservative majority guts abortion rights nationally, Dr. Jacobson said. She bases her estimate on new data from the Guttmacher Institute, a research organization that supports abortion and reproductive health rights.

She is adding staff members and appointment capacity, hoping to accommodate everyone.

“We have to make sure we can still continue to care for all of our California patients,” Dr. Jacobson said. “We don’t want them getting squeezed out” of appointments.

The Texas law banned nearly all abortions after about 6 weeks of pregnancy and empowered private citizens to sue anyone who performs or “aids and abets” an abortion after that time. The Supreme Court heard arguments in that case on Nov. 1 and is expected to announce a ruling on its constitutionality in June. Nonetheless, Florida and Ohio have announced plans for copycat laws.

Next month the high court will hear another abortion case with even broader implications, Dobbs v. Jackson Women’s Health Organization, a lawsuit challenging the constitutionality of a 2018 Mississippi law that prohibited abortion after 15 weeks. If the court sides with Mississippi, its decision could overturn existing abortion rights set by the landmark Roe v. Wade case.

Should that happen, reproductive rights experts predict, 26 states will ban the procedure altogether, and states with stronger protections for abortion, like California, will draw even more patients. There could be up to a 3,000% increase in people who “may drive to California for abortion care” each year, according to the Guttmacher data.

In 2017, the most recent year for which data are available from Guttmacher, California – by far the nation’s most populous state – had more abortion providers than any other state, with 419 hospitals, clinics, or doctors’ offices performing the procedure. The next highest were New York, with 252, and Florida, with 85. Neighboring Arizona and Nevada each had 11. Of the 862,320 abortions performed in the United States that year, 132.680, about 15% were in California.

Planned Parenthood clinics in California say they already serve about 7,000 out-of-state patients a year and are expecting a surge of new ones, especially in travel hubs like the Los Angeles area.

In September, Planned Parenthood and groups such as Black Women for Wellness convened the California Future of Abortion Council with backing from influential Democratic leaders including Gov. Newsom, state Senate leader Toni Atkins, and Assembly Speaker Anthony Rendon.

Ms. Atkins, who was the director of a San Diego women’s health clinic in the 1980s, said she spent time with women from states where it was hard to get an abortion. She said California is committed to ensuring abortion access in the state and beyond.

The council is focused on increasing funding for abortion services, providing logistical and financial help for women who need to travel, increasing the number of health care providers who perform abortions, and strengthening legal protections for them.

Increasing capacity could mean licensing more practitioners to provide abortions or pumping more resources into telehealth so people can see a doctor online to prescribe pills for a medical abortion – a service California doctors currently can provide to patients only in California.

The most important thing the state should do is fix its shortage of providers, especially those who perform second-trimester abortions, which are more expensive and complicated than first-trimester abortions, said council member Daniel Grossman, MD, director of the Advancing New Standards in Reproductive Health program at the University of California, San Francisco.

It’s not feasible to place an abortion provider in every corner of the state, Dr. Grossman said. Instead, the council should focus on creating “hubs that can provide abortion care for large numbers of people” in easy-to-get-to locations.

California already struggles to provide abortions to all who seek them, especially low-income women covered by Medi-Cal, California’s Medicaid program. For example, 28 counties – home to 10% of Medi-Cal recipients of childbearing age – don’t have facilities that provide abortions to Medi-Cal patients.

A medical abortion, in which pills are used to terminate a pregnancy, costs California patients an average of $306 out-of-pocket, according to an analysis by the California Health Benefits Review Program, but isn’t available after 10 weeks. After that, the only option is a surgical abortion, which costs an average of $887 out-of-pocket in California.

One of the council’s recommendations will likely be to increase the rate Medi-Cal payments for abortions so more providers will perform them, said council member Fabiola Carrión, interim director for reproductive and sexual health at the National Health Law Program.

Medi-Cal pays $354.43 for a second-trimester abortion. A 2020 study in the journal Contraception found that states paid between $79 and $626 for a second-trimester abortion in 2017.

Increasing Medi-Cal rates won’t help patients traveling from outside California. Generally, private insurance doesn’t cover out-of-state abortions, so most women will be on the hook for the full cost, and those enrolled in other states’ Medicaid programs must pay out-of-pocket, too.

The council hopes to reduce costs for state residents and visitors, said Brandon Richards, director of communications for Planned Parenthood Affiliates of California. “It’s about making it easy for people to access abortion in California, whether they reside here or are coming in from out of state,” he said.

One way to target costs is by funding the practical support, like helping to pay for transportation, child care, hotels, or time off work, said council member Jessica Pinckney, executive director of Access Reproductive Justice, a fund that helps people pay for abortions.

Ms. Pinckney said she’s working with Los Angeles County to set up a public abortion fund to cover some of those costs for anyone seeking an abortion in the county. It would be modeled after similar pots maintained by the cities of New York; Austin, Tex.; and Portland, Ore., and could eventually be a template for the first statewide fund, Ms. Pinckney said.

Most Texans seeking abortions since that state’s law took effect are going to nearby states like Colorado, New Mexico, and Oklahoma, said Sierra Harris, deputy director of network strategies for the National Network of Abortion Funds. Women in those states, in turn, are having trouble getting care and are looking to California for appointments.

Practical support is important for out-of-state patients, said Alissa Perrucci, PhD, MPH, operations manager at the Women’s Options Center at Zuckerberg San Francisco General Hospital, one of five abortion clinics inside California hospitals.

Dr. Perrucci’s clinic is focusing on telemedicine, phone counseling, and other ways to save time so it can add appointments for out-of-state patients if necessary.

But more slots are useless if women can’t make it to California. The clinic has booked about 10 appointments for Texans since the state’s ban went into effect, but only half have shown up, mostly women with family connections in California.

“Most people just don’t have the money to get here,” she said. “If the burden of abortion was borne predominantly by the wealthy, yeah, they’d just fly here.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

New data from England show the success of the national program for vaccinating girls against human papillomavirus (HPV) to prevent cervical cancer.

Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.

“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”

“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.

Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.

“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.

The study was published online Nov. 3, 2021, in The Lancet.

Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.

“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.

“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
 

National vaccination program

The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.

In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.

The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
 

Population-based registry

The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.

The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.

The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.

In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.

The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.

The team analyzed the data for each of these cohorts.

Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.

For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.

For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.

The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
 

Editorial commentary

“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.

“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.

“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”

The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.

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

New data from England show the success of the national program for vaccinating girls against human papillomavirus (HPV) to prevent cervical cancer.

Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.

“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”

“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.

Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.

“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.

The study was published online Nov. 3, 2021, in The Lancet.

Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.

“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.

“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
 

National vaccination program

The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.

In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.

The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
 

Population-based registry

The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.

The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.

The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.

In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.

The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.

The team analyzed the data for each of these cohorts.

Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.

For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.

For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.

The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
 

Editorial commentary

“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.

“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.

“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”

The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.

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

New data from England show the success of the national program for vaccinating girls against human papillomavirus (HPV) to prevent cervical cancer.

Among young women who received the HPV vaccine when they were 12-13 years old (before their sexual debut), cervical cancer rates are 87% lower than among previous nonvaccinated generations.

“It’s been incredible to see the impact of HPV vaccination, and now we can prove it prevented hundreds of women from developing cancer in England,” senior author Peter Sasieni, MD, King’s College London, said in a statement. “To see the real-life impact of the vaccine has been truly rewarding.”

“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” Kate Soldan, MD, U.K. Health Security Agency, London, commented in a statement.

Vanessa Saliba, MD, a consultant epidemiologist for the U.K. Health Security Agency, agreed, saying that “these remarkable findings confirm that the HPV vaccine saves lives by dramatically reducing cervical cancer rates among women.

“This reminds us that vaccines are one of the most important tools we have to help us live longer, healthier lives,” she added.

The study was published online Nov. 3, 2021, in The Lancet.

Approached for comment on the new study, Maurice Markman, MD, president, Medicine and Science Cancer Treatment Centers of America, noted that the results of the English study are very similar to those of a Swedish study of the quadrivalent vaccine alone.

“You can put any superlatives you want in here, but these are stunningly positive results,” Dr. Markman said in an interview. He said that, as an oncologist who has been treating cervical cancer for 40 years, particularly patients with advanced cervical cancer, “I can tell you this is one of the most devastating diseases to women, and the ability to eliminate this cancer with something as simple as a vaccine is the goal of cancer therapy, and it’s been remarkably successful.

“I can only emphasize the critical importance of all parents to see that their children who are eligible for the vaccine receive it. This is a cancer prevention strategy that is unbelievably, remarkably effective and safe,” Dr. Markman added.
 

National vaccination program

The national HPV vaccination program in England began in 2008. Initially, the bivalent Cervarix vaccine against HPV 16 and 18 was used. HPV 16 and 18 are responsible for 70% to 80% of all cervical cancers in England, the researchers note in their article.

In 2012, the program switched to the quadrivalent HPV vaccine (Gardasil), which is effective against two additional HPV types, HPV 6 and 11. Those strains cause genital warts.

The prevention program originally recommended a three-dose regimen in which both HPV vaccines were used. Currently, two doses are given to girls younger than 15 years. In addition, a single dose of the HPV vaccine provides good protection against persistent infection. The efficacy rate of a single dose is similar to that of three doses, the authors comment.
 

Population-based registry

The new data come from a population-based cancer registry that shows the incidence of cervical cancer and noninvasive cervical carcinoma (CIN3) in England between January 2006 and June 2019.

The study included seven cohorts of women who were aged 20-64 years at the end of 2019. Three of these cohorts composed the vaccinated population.

The team reports that overall, from January 2006 to June 2019, there were 27,946 cases of cervical cancer and 318,058 cases of CIN3.

In the three vaccinated cohorts, there were around 450 fewer cases of cervical cancer and 17,200 fewer cases of CIN3 than would be expected in a nonvaccinated population.

The three vaccinated cohorts had been eligible to receive Cervarix when they were aged 12-13 years. A catch-up scheme aimed at 14- to 16-year-olds and 16- to 18-year-olds. Most of these persons were vaccinated through a school vaccination program.

The team analyzed the data for each of these cohorts.

Among the cohort eligible for vaccination at 12-13 years of age, 89% received at least one dose of the HPV vaccine; 85% received three shots and were fully vaccinated. Among these persons, the rate of cervical cancer was 87% lower than expected in a nonvaccinated population, and the rate of CIN3 was 97% lower than expected.

For the cohort that was eligible to be vaccinated between the ages of 14 and 16 years, the corresponding reductions were 62% for cervical cancer and 75% for CIN3.

For the cohort eligible for vaccination between the ages of 16 and 18 years (of whom 60% had received at least one dose and 45% were fully vaccinated), the corresponding reduction were 34% for cervical cancer and 39% for CIN3.

The authors acknowledge some limitations with the study, principally that cervical cancer is rare in young women, and these vaccinated populations are still young. The youngest would have been vaccinated at age 12 in 2008 and so would be only 23 years old in 2019, when the follow-up in this current study ended. The authors emphasize that because the vaccinated populations are still young, it is too early to assess the full impact of HPV vaccination on cervical cancer rates.
 

Editorial commentary

“The relative reductions in cervical cancer, expected as a result of the HPV vaccination program, support the anticipated vaccine effectiveness,” commented two authors of an accompanying editorial, Maggie Cruickshank, MD, University of Aberdeen (Scotland), and Mihaela Grigore, MD, University of Medicine and Pharmacy, Lasi, Romania.

“The scale of the HPV vaccination effect reported by this study should also stimulate vaccination programs in low-income and middle-income countries where the problem of cervical cancer is a far greater public health issue than in those with well established systems of vaccination and screening,” they comment.

“The most important issue, besides the availability of the vaccine ... is the education of the population to accept the vaccination because a high rate of immunization is a key element of success,” they emphasize. “Even in a wealthy country, such as England with free access to HPV immunization, uptake has not reached the 90% vaccination target of girls aged 15 years set by WHO [World Health Organization].”

The authors and editorialists disclosed no relevant financial relationships. Dr. Markman is a regular contributor to Medscape Oncology. He has received income of $250 or more from Genentech, AstraZeneca, Celgene, Clovis, and Amgen.

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

The prevalence of T2DM is on the rise in the United States, and T2DM is currently the 7th leading cause of death.¹ In a study of 28,143 participants in the US National Health and Nutrition Examination Survey (NHANES) who were 18 years or older, the prevalence of diabetes increased from 9.8% to 14.3% between 2000 and 2008.² About 24% of the participants had undiagnosed diabetes prior to the testing they received as a study participant.² People from minority groups have a higher rate of T2DM than non-Hispanic White people. Using data from 2018, the Centers for Disease Control and Prevention reported that the prevalence of diagnosed diabetes was highest among American Indians/Alaska Natives (14.7%), people of Hispanic origin (12.5%), and non-Hispanic Blacks (11.7%), followed by non-Hispanic Asians (9.2%) and non-Hispanic Whites (7.5%).¹ Diabetes is a major risk factor for myocardial infarction, stroke, renal failure, retinopathy, peripheral vascular disease, and neuropathy.¹ Early detection and treatment of both prediabetes and diabetes may improve health and reduce these preventable complications, saving lives, preventing heart and renal failure and blindness.

T2DM is caused by a combination of insulin resistance and insufficient pancreatic secretion of insulin to overcome the insulin resistance.³ In young adults with insulin resistance, pancreatic secretion of insulin is often sufficient to overcome the insulin resistance resulting in normal glucose levels and persistently increased insulin concentration. As individuals with insulin resistance age, pancreatic secretion of insulin may decline, resulting in insufficient production of insulin and rising glucose levels. Many individuals experience a prolonged stage of prediabetes that may be present for decades prior to transitioning to T2DM. In 2020, 35% of US adults were reported to have prediabetes.¹

Screening for diabetes mellitus

The US Preventive Services Task Force (USPSTF) recently recommended that all adults aged 35 to 70 years who are overweight or obese be screened for T2DM (B recommendation).⁴ Screening for diabetes will also result in detecting many people with prediabetes. The criteria for diagnosing diabetes and prediabetes are presented in the TABLE. Based on cohort studies, the USPSTF noted that screening every 3 years is a reasonable approach.⁴ They also recommended that people diagnosed with prediabetes should initiate preventive measures, including optimizing diet, weight loss, exercise, and in some cases, medication treatment such as metformin.⁵

Approaches to the diagnosis of diabetes and prediabetes

Three laboratory tests are widely utilized for the diagnosis of prediabetes and diabetes: measurement of a plasma glucose 2 hours following consumption of oral glucose 75 g (2-hr oral glucose tolerance test [OGTT]), measurement of a fasting plasma glucose, and measurement of hemoglobin A_1c (see Table).⁶In clinical practice, the best diabetes screening test is the test the patient will complete. Most evidence indicates that, compared with the 2-hr OGTT, a hemoglobin A_1c measurement is specific for diagnosing T2DM, but not sensitive. In other words, if the hemoglobin A_1c is ≥6.5%, the glucose measurement 2 hours following an OGTT will very likely be ≥200 mg/dL. But if the hemoglobin A_1c is between 5.7% and 6.5%, the person might be diagnosed with T2DM if they had a 2-hr OGTT.⁶

In one study, 1,241 nondiabetic, overweight, or obese participants had all 3 tests to diagnose T2DM.⁷ The 2-hr OGTT diagnosed T2DM in 148 participants (12%). However, the hemoglobin A_1c test only diagnosed T2DM in 78 of the 148 participants who were diagnosed with T2DM based on the 2-hr OGTT, missing 47% of the cases of T2DM. In this study, using the 2-hr OGTT as the “gold standard” reference test, the hemoglobin A_1c test had a sensitivity of 53% and specificity of 97%.⁷

In clinical practice one approach is to explain to the patient the pros and cons of the 3 tests for T2DM and ask them to select the test they prefer to complete. In a high-risk population, including people with obesity, completing any of the 3 tests is better than not testing for diabetes. It also should be noted that, among people who have a normal body mass index (BMI), a “prediabetes” diagnosis is controversial. Compared with obese persons with prediabetes, people with a normal BMI and prediabetes diagnosed by a blood test progress to diabetes at a much lower rate. The value of diagnosing prediabetes after 70 years of age is also controversial because few people in this situation progress to diabetes.⁸ Clinicians should be cautious about diagnosing prediabetes in lean or elderly people.

The reliability of the hemoglobin A_1c test is reduced in conditions associated with increased red blood cell turnover, including sickle cell disease, pregnancy (second and third trimesters), hemodialysis, recent blood transfusions or erythropoietin therapy. In these clinical situations, only blood glucose measurements should be used to diagnose prediabetes and T2DM.⁶ It should be noted that concordance among any of the 3 tests is not perfect.⁶

Continue to: A 2-step approach to diagnosing T2DM...

An alternative to relying on a single test for T2DM is to use a 2-step approach for screening. The first step is a hemoglobin A_1c measurement, which neither requires fasting nor waiting for 2 hours for post–glucose load blood draw. If the hemoglobin A_1c result is ≥6.5%, a T2DM diagnosis can be made, with no additional testing. If the hemoglobin A_1c result is 5.7% to 6.4%, the person probably has either prediabetes or diabetes and can be offered a 2-hr OGTT to definitively determine if T2DM is the proper diagnosis. If the hemoglobin A_1c test is <5.7%, it is unlikely that the person has T2DM or prediabetes at the time of the test. In this situation, the testing could be repeated in 3 years. Using a 2-step approach reduces the number of people who are tested with a 2-hr OGTT and detects more cases of T2DM than a 1-step approach that relies on a hemoglobin A_1c measurement alone.

Treatment of prediabetes is warranted in people at high risk for developing diabetes

It is better to prevent diabetes among people with a high risk of diabetes than to treat diabetes once it is established. People with prediabetes who are overweight or obese are at high risk for developing diabetes. Prediabetes is diagnosed by a fasting plasma glucose level of 100 to 125 mg/dL or a hemoglobin A_1c measurement of 5.7% to 6.4%.

High-quality randomized clinical trials have definitively demonstrated that, among people at high risk for developing diabetes, lifestyle modification and metformin treatment reduce the risk of developing diabetes. In the Diabetes Prevention Program (DPP) 3,234 people with a high risk of diabetes, mean BMI 34 kg/m², were randomly assigned to 1 of 3 groups⁹:

• a control group
• metformin (850 mg twice daily) or
• lifestyle modification that included exercise (moderate intensity exercise for 150 minutes per week and weight loss (7% of body weight using a low-calorie, low-fat diet).

At 2.8 years of follow-up the incidence of diabetes was 11%, 7.8%, and 4.8% per 100 person-years in the people assigned to the control, metformin, and lifestyle modification groups, respectively.⁹ In the DPP study, compared with the control group, metformin was most effective in decreasing the risk of transitioning to diabetes in people who had a BMI ≥35 kg/m² (53% reduction in risk) or a BMI from 30 to 35 kg/m² (16% reduction in risk).⁹ Metformin was not as effective at preventing the transition to diabetes in people who had a normal BMI or who were overweight (3% reduction).⁹

In the Finnish Diabetes Prevention Study, 522 obese people with impaired glucose tolerance were randomly assigned to lifestyle modification or a control group. After 4 years, the cumulative incidence of diabetes was 11% and 23% in the lifestyle modification and control groups, respectively.¹⁰ A meta-analysis of 23 randomized clinical trials reported that, among people with a high risk of developing diabetes, compared with no intervention (control group), lifestyle modification, including dieting, exercising, and weight loss significantly reduced the risk of developing diabetes (pooled relative risk [RR], 0.78; 95% confidence interval [CI], 0.69‒0.88).⁵

In clinical practice, offering a patient at high risk for diabetes a suite of options, including^5,9,10:

• a formal nutrition consult with the goal of targeting a 7% reduction in weight
• recommending moderate intensity exercise, 150 minutes weekly
• metformin treatment, if the patient is obese

would reduce the patient’s risk of developing diabetes.

Treatment of T2DM is complex

For people with T2DM, a widely recommended treatment goal is to reduce the hemoglobin A_1c measurement to ≤7%. Initial treatment includes a comprehensive diabetes self-management education program, weight loss using diet and exercise, and metformin treatment. Metformin may be associated with an increased risk of lactic acidosis, especially in people with renal insufficiency. The US Food and Drug Administration (FDA) recommends against initiating metformin therapy for people with an estimated glomerular filtration rate (eGFR) of 30 to 45 mL/min/1.73 m². The FDA determined that metformin is contraindicated in people with an eGFR of <30 mL/min/1.73 m².¹¹ Many people with T2DM will require treatment with multiple pharmacologic agents to achieve a hemoglobin A_1c ≤7%. In addition to metformin, pharmacologic agents used to treat T2DM include insulin, sulfonylureas, glucagon-like peptide-1(GLP-1) receptor agonists, a sodium glucose cotransporter (SGLT2) inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitors, or an alpha-glucosidase inhibitor. Given the complexity of managing T2DM over a lifetime, most individuals with T2DM receive their diabetes care from a primary care clinician or subspecialist in endocrinology.

Experts predict that, within the next 8 years, the prevalence of obesity among adults in the United States will be approximately 50%.¹² The US health care system has not been effective in controlling the obesity epidemic. Our failure to control the obesity epidemic will result in an increase in the prevalence of prediabetes and T2DM, leading to a rise in cardiovascular, renal, and eye disease. The diagnosis of prediabetes and diabetes is within the scope of practice of obstetrics and gynecology. The treatment of prediabetes is also within the scope of ObGyns, who have both expertise and familiarity in the diagnosis of gestational diabetes, a form of prediabetes. ●

The prevalence of T2DM is on the rise in the United States, and T2DM is currently the 7th leading cause of death.¹ In a study of 28,143 participants in the US National Health and Nutrition Examination Survey (NHANES) who were 18 years or older, the prevalence of diabetes increased from 9.8% to 14.3% between 2000 and 2008.² About 24% of the participants had undiagnosed diabetes prior to the testing they received as a study participant.² People from minority groups have a higher rate of T2DM than non-Hispanic White people. Using data from 2018, the Centers for Disease Control and Prevention reported that the prevalence of diagnosed diabetes was highest among American Indians/Alaska Natives (14.7%), people of Hispanic origin (12.5%), and non-Hispanic Blacks (11.7%), followed by non-Hispanic Asians (9.2%) and non-Hispanic Whites (7.5%).¹ Diabetes is a major risk factor for myocardial infarction, stroke, renal failure, retinopathy, peripheral vascular disease, and neuropathy.¹ Early detection and treatment of both prediabetes and diabetes may improve health and reduce these preventable complications, saving lives, preventing heart and renal failure and blindness.

T2DM is caused by a combination of insulin resistance and insufficient pancreatic secretion of insulin to overcome the insulin resistance.³ In young adults with insulin resistance, pancreatic secretion of insulin is often sufficient to overcome the insulin resistance resulting in normal glucose levels and persistently increased insulin concentration. As individuals with insulin resistance age, pancreatic secretion of insulin may decline, resulting in insufficient production of insulin and rising glucose levels. Many individuals experience a prolonged stage of prediabetes that may be present for decades prior to transitioning to T2DM. In 2020, 35% of US adults were reported to have prediabetes.¹

Screening for diabetes mellitus

The US Preventive Services Task Force (USPSTF) recently recommended that all adults aged 35 to 70 years who are overweight or obese be screened for T2DM (B recommendation).⁴ Screening for diabetes will also result in detecting many people with prediabetes. The criteria for diagnosing diabetes and prediabetes are presented in the TABLE. Based on cohort studies, the USPSTF noted that screening every 3 years is a reasonable approach.⁴ They also recommended that people diagnosed with prediabetes should initiate preventive measures, including optimizing diet, weight loss, exercise, and in some cases, medication treatment such as metformin.⁵

Approaches to the diagnosis of diabetes and prediabetes

Three laboratory tests are widely utilized for the diagnosis of prediabetes and diabetes: measurement of a plasma glucose 2 hours following consumption of oral glucose 75 g (2-hr oral glucose tolerance test [OGTT]), measurement of a fasting plasma glucose, and measurement of hemoglobin A_1c (see Table).⁶In clinical practice, the best diabetes screening test is the test the patient will complete. Most evidence indicates that, compared with the 2-hr OGTT, a hemoglobin A_1c measurement is specific for diagnosing T2DM, but not sensitive. In other words, if the hemoglobin A_1c is ≥6.5%, the glucose measurement 2 hours following an OGTT will very likely be ≥200 mg/dL. But if the hemoglobin A_1c is between 5.7% and 6.5%, the person might be diagnosed with T2DM if they had a 2-hr OGTT.⁶

In one study, 1,241 nondiabetic, overweight, or obese participants had all 3 tests to diagnose T2DM.⁷ The 2-hr OGTT diagnosed T2DM in 148 participants (12%). However, the hemoglobin A_1c test only diagnosed T2DM in 78 of the 148 participants who were diagnosed with T2DM based on the 2-hr OGTT, missing 47% of the cases of T2DM. In this study, using the 2-hr OGTT as the “gold standard” reference test, the hemoglobin A_1c test had a sensitivity of 53% and specificity of 97%.⁷

In clinical practice one approach is to explain to the patient the pros and cons of the 3 tests for T2DM and ask them to select the test they prefer to complete. In a high-risk population, including people with obesity, completing any of the 3 tests is better than not testing for diabetes. It also should be noted that, among people who have a normal body mass index (BMI), a “prediabetes” diagnosis is controversial. Compared with obese persons with prediabetes, people with a normal BMI and prediabetes diagnosed by a blood test progress to diabetes at a much lower rate. The value of diagnosing prediabetes after 70 years of age is also controversial because few people in this situation progress to diabetes.⁸ Clinicians should be cautious about diagnosing prediabetes in lean or elderly people.

The reliability of the hemoglobin A_1c test is reduced in conditions associated with increased red blood cell turnover, including sickle cell disease, pregnancy (second and third trimesters), hemodialysis, recent blood transfusions or erythropoietin therapy. In these clinical situations, only blood glucose measurements should be used to diagnose prediabetes and T2DM.⁶ It should be noted that concordance among any of the 3 tests is not perfect.⁶

Continue to: A 2-step approach to diagnosing T2DM...

An alternative to relying on a single test for T2DM is to use a 2-step approach for screening. The first step is a hemoglobin A_1c measurement, which neither requires fasting nor waiting for 2 hours for post–glucose load blood draw. If the hemoglobin A_1c result is ≥6.5%, a T2DM diagnosis can be made, with no additional testing. If the hemoglobin A_1c result is 5.7% to 6.4%, the person probably has either prediabetes or diabetes and can be offered a 2-hr OGTT to definitively determine if T2DM is the proper diagnosis. If the hemoglobin A_1c test is <5.7%, it is unlikely that the person has T2DM or prediabetes at the time of the test. In this situation, the testing could be repeated in 3 years. Using a 2-step approach reduces the number of people who are tested with a 2-hr OGTT and detects more cases of T2DM than a 1-step approach that relies on a hemoglobin A_1c measurement alone.

Treatment of prediabetes is warranted in people at high risk for developing diabetes

It is better to prevent diabetes among people with a high risk of diabetes than to treat diabetes once it is established. People with prediabetes who are overweight or obese are at high risk for developing diabetes. Prediabetes is diagnosed by a fasting plasma glucose level of 100 to 125 mg/dL or a hemoglobin A_1c measurement of 5.7% to 6.4%.

High-quality randomized clinical trials have definitively demonstrated that, among people at high risk for developing diabetes, lifestyle modification and metformin treatment reduce the risk of developing diabetes. In the Diabetes Prevention Program (DPP) 3,234 people with a high risk of diabetes, mean BMI 34 kg/m², were randomly assigned to 1 of 3 groups⁹:

• a control group
• metformin (850 mg twice daily) or
• lifestyle modification that included exercise (moderate intensity exercise for 150 minutes per week and weight loss (7% of body weight using a low-calorie, low-fat diet).

At 2.8 years of follow-up the incidence of diabetes was 11%, 7.8%, and 4.8% per 100 person-years in the people assigned to the control, metformin, and lifestyle modification groups, respectively.⁹ In the DPP study, compared with the control group, metformin was most effective in decreasing the risk of transitioning to diabetes in people who had a BMI ≥35 kg/m² (53% reduction in risk) or a BMI from 30 to 35 kg/m² (16% reduction in risk).⁹ Metformin was not as effective at preventing the transition to diabetes in people who had a normal BMI or who were overweight (3% reduction).⁹

In the Finnish Diabetes Prevention Study, 522 obese people with impaired glucose tolerance were randomly assigned to lifestyle modification or a control group. After 4 years, the cumulative incidence of diabetes was 11% and 23% in the lifestyle modification and control groups, respectively.¹⁰ A meta-analysis of 23 randomized clinical trials reported that, among people with a high risk of developing diabetes, compared with no intervention (control group), lifestyle modification, including dieting, exercising, and weight loss significantly reduced the risk of developing diabetes (pooled relative risk [RR], 0.78; 95% confidence interval [CI], 0.69‒0.88).⁵

In clinical practice, offering a patient at high risk for diabetes a suite of options, including^5,9,10:

• a formal nutrition consult with the goal of targeting a 7% reduction in weight
• recommending moderate intensity exercise, 150 minutes weekly
• metformin treatment, if the patient is obese

would reduce the patient’s risk of developing diabetes.

Treatment of T2DM is complex

For people with T2DM, a widely recommended treatment goal is to reduce the hemoglobin A_1c measurement to ≤7%. Initial treatment includes a comprehensive diabetes self-management education program, weight loss using diet and exercise, and metformin treatment. Metformin may be associated with an increased risk of lactic acidosis, especially in people with renal insufficiency. The US Food and Drug Administration (FDA) recommends against initiating metformin therapy for people with an estimated glomerular filtration rate (eGFR) of 30 to 45 mL/min/1.73 m². The FDA determined that metformin is contraindicated in people with an eGFR of <30 mL/min/1.73 m².¹¹ Many people with T2DM will require treatment with multiple pharmacologic agents to achieve a hemoglobin A_1c ≤7%. In addition to metformin, pharmacologic agents used to treat T2DM include insulin, sulfonylureas, glucagon-like peptide-1(GLP-1) receptor agonists, a sodium glucose cotransporter (SGLT2) inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitors, or an alpha-glucosidase inhibitor. Given the complexity of managing T2DM over a lifetime, most individuals with T2DM receive their diabetes care from a primary care clinician or subspecialist in endocrinology.

Experts predict that, within the next 8 years, the prevalence of obesity among adults in the United States will be approximately 50%.¹² The US health care system has not been effective in controlling the obesity epidemic. Our failure to control the obesity epidemic will result in an increase in the prevalence of prediabetes and T2DM, leading to a rise in cardiovascular, renal, and eye disease. The diagnosis of prediabetes and diabetes is within the scope of practice of obstetrics and gynecology. The treatment of prediabetes is also within the scope of ObGyns, who have both expertise and familiarity in the diagnosis of gestational diabetes, a form of prediabetes. ●

The prevalence of T2DM is on the rise in the United States, and T2DM is currently the 7th leading cause of death.¹ In a study of 28,143 participants in the US National Health and Nutrition Examination Survey (NHANES) who were 18 years or older, the prevalence of diabetes increased from 9.8% to 14.3% between 2000 and 2008.² About 24% of the participants had undiagnosed diabetes prior to the testing they received as a study participant.² People from minority groups have a higher rate of T2DM than non-Hispanic White people. Using data from 2018, the Centers for Disease Control and Prevention reported that the prevalence of diagnosed diabetes was highest among American Indians/Alaska Natives (14.7%), people of Hispanic origin (12.5%), and non-Hispanic Blacks (11.7%), followed by non-Hispanic Asians (9.2%) and non-Hispanic Whites (7.5%).¹ Diabetes is a major risk factor for myocardial infarction, stroke, renal failure, retinopathy, peripheral vascular disease, and neuropathy.¹ Early detection and treatment of both prediabetes and diabetes may improve health and reduce these preventable complications, saving lives, preventing heart and renal failure and blindness.

T2DM is caused by a combination of insulin resistance and insufficient pancreatic secretion of insulin to overcome the insulin resistance.³ In young adults with insulin resistance, pancreatic secretion of insulin is often sufficient to overcome the insulin resistance resulting in normal glucose levels and persistently increased insulin concentration. As individuals with insulin resistance age, pancreatic secretion of insulin may decline, resulting in insufficient production of insulin and rising glucose levels. Many individuals experience a prolonged stage of prediabetes that may be present for decades prior to transitioning to T2DM. In 2020, 35% of US adults were reported to have prediabetes.¹

Screening for diabetes mellitus

The US Preventive Services Task Force (USPSTF) recently recommended that all adults aged 35 to 70 years who are overweight or obese be screened for T2DM (B recommendation).⁴ Screening for diabetes will also result in detecting many people with prediabetes. The criteria for diagnosing diabetes and prediabetes are presented in the TABLE. Based on cohort studies, the USPSTF noted that screening every 3 years is a reasonable approach.⁴ They also recommended that people diagnosed with prediabetes should initiate preventive measures, including optimizing diet, weight loss, exercise, and in some cases, medication treatment such as metformin.⁵

Approaches to the diagnosis of diabetes and prediabetes

Three laboratory tests are widely utilized for the diagnosis of prediabetes and diabetes: measurement of a plasma glucose 2 hours following consumption of oral glucose 75 g (2-hr oral glucose tolerance test [OGTT]), measurement of a fasting plasma glucose, and measurement of hemoglobin A_1c (see Table).⁶In clinical practice, the best diabetes screening test is the test the patient will complete. Most evidence indicates that, compared with the 2-hr OGTT, a hemoglobin A_1c measurement is specific for diagnosing T2DM, but not sensitive. In other words, if the hemoglobin A_1c is ≥6.5%, the glucose measurement 2 hours following an OGTT will very likely be ≥200 mg/dL. But if the hemoglobin A_1c is between 5.7% and 6.5%, the person might be diagnosed with T2DM if they had a 2-hr OGTT.⁶

In one study, 1,241 nondiabetic, overweight, or obese participants had all 3 tests to diagnose T2DM.⁷ The 2-hr OGTT diagnosed T2DM in 148 participants (12%). However, the hemoglobin A_1c test only diagnosed T2DM in 78 of the 148 participants who were diagnosed with T2DM based on the 2-hr OGTT, missing 47% of the cases of T2DM. In this study, using the 2-hr OGTT as the “gold standard” reference test, the hemoglobin A_1c test had a sensitivity of 53% and specificity of 97%.⁷

In clinical practice one approach is to explain to the patient the pros and cons of the 3 tests for T2DM and ask them to select the test they prefer to complete. In a high-risk population, including people with obesity, completing any of the 3 tests is better than not testing for diabetes. It also should be noted that, among people who have a normal body mass index (BMI), a “prediabetes” diagnosis is controversial. Compared with obese persons with prediabetes, people with a normal BMI and prediabetes diagnosed by a blood test progress to diabetes at a much lower rate. The value of diagnosing prediabetes after 70 years of age is also controversial because few people in this situation progress to diabetes.⁸ Clinicians should be cautious about diagnosing prediabetes in lean or elderly people.

The reliability of the hemoglobin A_1c test is reduced in conditions associated with increased red blood cell turnover, including sickle cell disease, pregnancy (second and third trimesters), hemodialysis, recent blood transfusions or erythropoietin therapy. In these clinical situations, only blood glucose measurements should be used to diagnose prediabetes and T2DM.⁶ It should be noted that concordance among any of the 3 tests is not perfect.⁶

Continue to: A 2-step approach to diagnosing T2DM...

An alternative to relying on a single test for T2DM is to use a 2-step approach for screening. The first step is a hemoglobin A_1c measurement, which neither requires fasting nor waiting for 2 hours for post–glucose load blood draw. If the hemoglobin A_1c result is ≥6.5%, a T2DM diagnosis can be made, with no additional testing. If the hemoglobin A_1c result is 5.7% to 6.4%, the person probably has either prediabetes or diabetes and can be offered a 2-hr OGTT to definitively determine if T2DM is the proper diagnosis. If the hemoglobin A_1c test is <5.7%, it is unlikely that the person has T2DM or prediabetes at the time of the test. In this situation, the testing could be repeated in 3 years. Using a 2-step approach reduces the number of people who are tested with a 2-hr OGTT and detects more cases of T2DM than a 1-step approach that relies on a hemoglobin A_1c measurement alone.

Treatment of prediabetes is warranted in people at high risk for developing diabetes

It is better to prevent diabetes among people with a high risk of diabetes than to treat diabetes once it is established. People with prediabetes who are overweight or obese are at high risk for developing diabetes. Prediabetes is diagnosed by a fasting plasma glucose level of 100 to 125 mg/dL or a hemoglobin A_1c measurement of 5.7% to 6.4%.

High-quality randomized clinical trials have definitively demonstrated that, among people at high risk for developing diabetes, lifestyle modification and metformin treatment reduce the risk of developing diabetes. In the Diabetes Prevention Program (DPP) 3,234 people with a high risk of diabetes, mean BMI 34 kg/m², were randomly assigned to 1 of 3 groups⁹:

• a control group
• metformin (850 mg twice daily) or
• lifestyle modification that included exercise (moderate intensity exercise for 150 minutes per week and weight loss (7% of body weight using a low-calorie, low-fat diet).

At 2.8 years of follow-up the incidence of diabetes was 11%, 7.8%, and 4.8% per 100 person-years in the people assigned to the control, metformin, and lifestyle modification groups, respectively.⁹ In the DPP study, compared with the control group, metformin was most effective in decreasing the risk of transitioning to diabetes in people who had a BMI ≥35 kg/m² (53% reduction in risk) or a BMI from 30 to 35 kg/m² (16% reduction in risk).⁹ Metformin was not as effective at preventing the transition to diabetes in people who had a normal BMI or who were overweight (3% reduction).⁹

In the Finnish Diabetes Prevention Study, 522 obese people with impaired glucose tolerance were randomly assigned to lifestyle modification or a control group. After 4 years, the cumulative incidence of diabetes was 11% and 23% in the lifestyle modification and control groups, respectively.¹⁰ A meta-analysis of 23 randomized clinical trials reported that, among people with a high risk of developing diabetes, compared with no intervention (control group), lifestyle modification, including dieting, exercising, and weight loss significantly reduced the risk of developing diabetes (pooled relative risk [RR], 0.78; 95% confidence interval [CI], 0.69‒0.88).⁵

In clinical practice, offering a patient at high risk for diabetes a suite of options, including^5,9,10:

• a formal nutrition consult with the goal of targeting a 7% reduction in weight
• recommending moderate intensity exercise, 150 minutes weekly
• metformin treatment, if the patient is obese

would reduce the patient’s risk of developing diabetes.

Treatment of T2DM is complex

For people with T2DM, a widely recommended treatment goal is to reduce the hemoglobin A_1c measurement to ≤7%. Initial treatment includes a comprehensive diabetes self-management education program, weight loss using diet and exercise, and metformin treatment. Metformin may be associated with an increased risk of lactic acidosis, especially in people with renal insufficiency. The US Food and Drug Administration (FDA) recommends against initiating metformin therapy for people with an estimated glomerular filtration rate (eGFR) of 30 to 45 mL/min/1.73 m². The FDA determined that metformin is contraindicated in people with an eGFR of <30 mL/min/1.73 m².¹¹ Many people with T2DM will require treatment with multiple pharmacologic agents to achieve a hemoglobin A_1c ≤7%. In addition to metformin, pharmacologic agents used to treat T2DM include insulin, sulfonylureas, glucagon-like peptide-1(GLP-1) receptor agonists, a sodium glucose cotransporter (SGLT2) inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitors, or an alpha-glucosidase inhibitor. Given the complexity of managing T2DM over a lifetime, most individuals with T2DM receive their diabetes care from a primary care clinician or subspecialist in endocrinology.

Experts predict that, within the next 8 years, the prevalence of obesity among adults in the United States will be approximately 50%.¹² The US health care system has not been effective in controlling the obesity epidemic. Our failure to control the obesity epidemic will result in an increase in the prevalence of prediabetes and T2DM, leading to a rise in cardiovascular, renal, and eye disease. The diagnosis of prediabetes and diabetes is within the scope of practice of obstetrics and gynecology. The treatment of prediabetes is also within the scope of ObGyns, who have both expertise and familiarity in the diagnosis of gestational diabetes, a form of prediabetes. ●