Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

The birth rate for U.S. teenagers dropped 3% in counties where a federally funded sex education program was introduced, a recently published paper says.

Researchers concentrated on the effects of the Teen Pregnancy Prevention program (TPP), which was introduced during the Obama administration and administered on the county level. TPP programs provide more information on sex, contraception, and reproductive health than abstinence-only programs, the paper said.

“Sex education in the United States has been hotly debated among researchers, policy makers, and the public,” Nicholas Mark, a doctoral candidate in New York University’s department of sociology and the lead author of the paper, said in a news release. “Our analysis provides evidence that funding for more comprehensive sex education led to an overall reduction in the teen birth rate at the county level of more than 3%.”

Researchers examined teen birth rates in 55 counties from 1996 to 2009, before TTP, and from 2010 to 2016, after TTP. Next, they compared teen birth rates in the 55 counties with teen birth rates in 2,800 counties that didn’t have the funding in the years before and after TPP was introduced.

In the 55 counties, teen birth rates fell 1.5% in the first year of TTP funding and fell about 7% by the fifth year of funding, for an average drop of 3%, the news release said.

“We’ve known for some time that abstinence-only programs are ineffective at reducing teen birth rates,” said Lawrence Wu, a professor in NYU’s department of sociology and the paper’s senior author. “This work shows that more wide-reaching sex education programs – those not limited to abstinence – are successful in lowering rates of teen births.”

The paper was published in the Proceedings of the National Academy of Sciences of the United States of America.

The paper said the findings probably understate the true effect of more comprehensive sex education at the individual level.

The authors said the findings are important because U.S. women are more likely to become mothers in their teens than women in other developed nations, with many teen pregnancies reported as unintended, the authors said.

As of 2020, teen birth rates and the number of births to teen mothers had dropped steadily since 1990. Teen birth rates fell by 70% over 3 decades.

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

The birth rate for U.S. teenagers dropped 3% in counties where a federally funded sex education program was introduced, a recently published paper says.

Researchers concentrated on the effects of the Teen Pregnancy Prevention program (TPP), which was introduced during the Obama administration and administered on the county level. TPP programs provide more information on sex, contraception, and reproductive health than abstinence-only programs, the paper said.

“Sex education in the United States has been hotly debated among researchers, policy makers, and the public,” Nicholas Mark, a doctoral candidate in New York University’s department of sociology and the lead author of the paper, said in a news release. “Our analysis provides evidence that funding for more comprehensive sex education led to an overall reduction in the teen birth rate at the county level of more than 3%.”

Researchers examined teen birth rates in 55 counties from 1996 to 2009, before TTP, and from 2010 to 2016, after TTP. Next, they compared teen birth rates in the 55 counties with teen birth rates in 2,800 counties that didn’t have the funding in the years before and after TPP was introduced.

In the 55 counties, teen birth rates fell 1.5% in the first year of TTP funding and fell about 7% by the fifth year of funding, for an average drop of 3%, the news release said.

“We’ve known for some time that abstinence-only programs are ineffective at reducing teen birth rates,” said Lawrence Wu, a professor in NYU’s department of sociology and the paper’s senior author. “This work shows that more wide-reaching sex education programs – those not limited to abstinence – are successful in lowering rates of teen births.”

The paper was published in the Proceedings of the National Academy of Sciences of the United States of America.

The paper said the findings probably understate the true effect of more comprehensive sex education at the individual level.

The authors said the findings are important because U.S. women are more likely to become mothers in their teens than women in other developed nations, with many teen pregnancies reported as unintended, the authors said.

As of 2020, teen birth rates and the number of births to teen mothers had dropped steadily since 1990. Teen birth rates fell by 70% over 3 decades.

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

The birth rate for U.S. teenagers dropped 3% in counties where a federally funded sex education program was introduced, a recently published paper says.

Researchers concentrated on the effects of the Teen Pregnancy Prevention program (TPP), which was introduced during the Obama administration and administered on the county level. TPP programs provide more information on sex, contraception, and reproductive health than abstinence-only programs, the paper said.

“Sex education in the United States has been hotly debated among researchers, policy makers, and the public,” Nicholas Mark, a doctoral candidate in New York University’s department of sociology and the lead author of the paper, said in a news release. “Our analysis provides evidence that funding for more comprehensive sex education led to an overall reduction in the teen birth rate at the county level of more than 3%.”

Researchers examined teen birth rates in 55 counties from 1996 to 2009, before TTP, and from 2010 to 2016, after TTP. Next, they compared teen birth rates in the 55 counties with teen birth rates in 2,800 counties that didn’t have the funding in the years before and after TPP was introduced.

In the 55 counties, teen birth rates fell 1.5% in the first year of TTP funding and fell about 7% by the fifth year of funding, for an average drop of 3%, the news release said.

“We’ve known for some time that abstinence-only programs are ineffective at reducing teen birth rates,” said Lawrence Wu, a professor in NYU’s department of sociology and the paper’s senior author. “This work shows that more wide-reaching sex education programs – those not limited to abstinence – are successful in lowering rates of teen births.”

The paper was published in the Proceedings of the National Academy of Sciences of the United States of America.

The paper said the findings probably understate the true effect of more comprehensive sex education at the individual level.

The authors said the findings are important because U.S. women are more likely to become mothers in their teens than women in other developed nations, with many teen pregnancies reported as unintended, the authors said.

As of 2020, teen birth rates and the number of births to teen mothers had dropped steadily since 1990. Teen birth rates fell by 70% over 3 decades.

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

Creating a legacy of giving is easier than you think. Take some time to start creating your legacy while supporting the AGA Research Foundation. Gifts to charitable organizations, such as the AGA Research Foundation, in your plans ensure your support for our mission continues for years to come.

Here are two ideas to help you get started.

• Name the AGA Research Foundation as a beneficiary. This arrangement is one of the most tax-smart ways to support the AGA Research Foundation after your lifetime. When you leave retirement plan assets to us, we bypass any taxes and receive the full amount.
• Include the AGA Research Foundation in your will or living trust. This gift can be made by including as little as one sentence in your will or living trust. Plus, your gift can be modified throughout your lifetime as circumstances change.

Want to learn more about including a gift to the AGA Research Foundation in your plans? Visit our website at https://gastro.planmylegacy.org. 

Creating a legacy of giving is easier than you think. Take some time to start creating your legacy while supporting the AGA Research Foundation. Gifts to charitable organizations, such as the AGA Research Foundation, in your plans ensure your support for our mission continues for years to come.

Here are two ideas to help you get started.

• Name the AGA Research Foundation as a beneficiary. This arrangement is one of the most tax-smart ways to support the AGA Research Foundation after your lifetime. When you leave retirement plan assets to us, we bypass any taxes and receive the full amount.
• Include the AGA Research Foundation in your will or living trust. This gift can be made by including as little as one sentence in your will or living trust. Plus, your gift can be modified throughout your lifetime as circumstances change.

Want to learn more about including a gift to the AGA Research Foundation in your plans? Visit our website at https://gastro.planmylegacy.org. 

Creating a legacy of giving is easier than you think. Take some time to start creating your legacy while supporting the AGA Research Foundation. Gifts to charitable organizations, such as the AGA Research Foundation, in your plans ensure your support for our mission continues for years to come.

Here are two ideas to help you get started.

• Name the AGA Research Foundation as a beneficiary. This arrangement is one of the most tax-smart ways to support the AGA Research Foundation after your lifetime. When you leave retirement plan assets to us, we bypass any taxes and receive the full amount.
• Include the AGA Research Foundation in your will or living trust. This gift can be made by including as little as one sentence in your will or living trust. Plus, your gift can be modified throughout your lifetime as circumstances change.

Want to learn more about including a gift to the AGA Research Foundation in your plans? Visit our website at https://gastro.planmylegacy.org. 

            Kishan et al conducted a meta-analysis to evaluate the relative effects of the addition of androgen deprivation therapy (ADT) to radiation therapy (RT) on metastasis-free survival (MFS) in patients with localized prostate cancer in the following three settings: 1) RT alone versus RT plus adjuvant ADT, 2) extension of ADT duration in the neoadjuvant setting before RT, and 3) extension of adjuvant ADT duration. MFS was increased in the adjuvant ADT setting, and prolongation of ADT duration was associated with a higher MFS than shorter duration. However, extension of neoadjuvant ADT was not associated with a higher MFS compared to a shorter duration. The meta-analysis further supports a longer versus shorter ADT duration, but it does not support a longer neoadjuvant ADT duration.

            To determine the effects of salvage RT on outcomes in the setting of biochemical relapse, Tilki et al conducted a retrospective cohort analysis of a multi-institutional database of patients with biochemical recurrence after radical prostatectomy (RP). MFS at 15 years post-RP was 84.3% in the RT group and 76.9% in the non-RT group, while overall survival (OS), also at 15 years post-RP, was 85.3% in the RT group versus 74.4% in the non-RT group (both analyses were statistically significant). While supportive of salvage RT, there was no data on prostate-specific antigen (PSA) doubling times, nor was it possible to control for imaging modality. It is possible that newer prostate-specific membrane antigen (PSMA)-based positron emission tomography imaging may affect MFS in studies such as these.

            Prostatectomy (with or without lymph node dissection), external beam RT (EBRT) with  ADT, or EBRT with brachytherapy (BT) with or without ADT are options in unfavorable intermediate-risk prostate cancer. The optimal use of BT in localized prostate cancer is somewhat uncertain, especially across the risk spectrum. Andruska et al conducted an analysis of the National Cancer Database (NCDB) to evaluate whether EBRT plus BT with or without ADT results in an improvement in overall survival (OS) compared with BT with or without ADT. OS was higher for the EBRT plus BT groups; however, when the ADT + EBRT + BT group was compared with EBRT + BT without ADT group, the improvement in OS was not statistically significant. Overall, the analysis favored EBRT + BT over BT alone, further supporting current guidelines.

            Kishan et al conducted a meta-analysis to evaluate the relative effects of the addition of androgen deprivation therapy (ADT) to radiation therapy (RT) on metastasis-free survival (MFS) in patients with localized prostate cancer in the following three settings: 1) RT alone versus RT plus adjuvant ADT, 2) extension of ADT duration in the neoadjuvant setting before RT, and 3) extension of adjuvant ADT duration. MFS was increased in the adjuvant ADT setting, and prolongation of ADT duration was associated with a higher MFS than shorter duration. However, extension of neoadjuvant ADT was not associated with a higher MFS compared to a shorter duration. The meta-analysis further supports a longer versus shorter ADT duration, but it does not support a longer neoadjuvant ADT duration.

            To determine the effects of salvage RT on outcomes in the setting of biochemical relapse, Tilki et al conducted a retrospective cohort analysis of a multi-institutional database of patients with biochemical recurrence after radical prostatectomy (RP). MFS at 15 years post-RP was 84.3% in the RT group and 76.9% in the non-RT group, while overall survival (OS), also at 15 years post-RP, was 85.3% in the RT group versus 74.4% in the non-RT group (both analyses were statistically significant). While supportive of salvage RT, there was no data on prostate-specific antigen (PSA) doubling times, nor was it possible to control for imaging modality. It is possible that newer prostate-specific membrane antigen (PSMA)-based positron emission tomography imaging may affect MFS in studies such as these.

            Prostatectomy (with or without lymph node dissection), external beam RT (EBRT) with  ADT, or EBRT with brachytherapy (BT) with or without ADT are options in unfavorable intermediate-risk prostate cancer. The optimal use of BT in localized prostate cancer is somewhat uncertain, especially across the risk spectrum. Andruska et al conducted an analysis of the National Cancer Database (NCDB) to evaluate whether EBRT plus BT with or without ADT results in an improvement in overall survival (OS) compared with BT with or without ADT. OS was higher for the EBRT plus BT groups; however, when the ADT + EBRT + BT group was compared with EBRT + BT without ADT group, the improvement in OS was not statistically significant. Overall, the analysis favored EBRT + BT over BT alone, further supporting current guidelines.

            Kishan et al conducted a meta-analysis to evaluate the relative effects of the addition of androgen deprivation therapy (ADT) to radiation therapy (RT) on metastasis-free survival (MFS) in patients with localized prostate cancer in the following three settings: 1) RT alone versus RT plus adjuvant ADT, 2) extension of ADT duration in the neoadjuvant setting before RT, and 3) extension of adjuvant ADT duration. MFS was increased in the adjuvant ADT setting, and prolongation of ADT duration was associated with a higher MFS than shorter duration. However, extension of neoadjuvant ADT was not associated with a higher MFS compared to a shorter duration. The meta-analysis further supports a longer versus shorter ADT duration, but it does not support a longer neoadjuvant ADT duration.

            To determine the effects of salvage RT on outcomes in the setting of biochemical relapse, Tilki et al conducted a retrospective cohort analysis of a multi-institutional database of patients with biochemical recurrence after radical prostatectomy (RP). MFS at 15 years post-RP was 84.3% in the RT group and 76.9% in the non-RT group, while overall survival (OS), also at 15 years post-RP, was 85.3% in the RT group versus 74.4% in the non-RT group (both analyses were statistically significant). While supportive of salvage RT, there was no data on prostate-specific antigen (PSA) doubling times, nor was it possible to control for imaging modality. It is possible that newer prostate-specific membrane antigen (PSMA)-based positron emission tomography imaging may affect MFS in studies such as these.

            Prostatectomy (with or without lymph node dissection), external beam RT (EBRT) with  ADT, or EBRT with brachytherapy (BT) with or without ADT are options in unfavorable intermediate-risk prostate cancer. The optimal use of BT in localized prostate cancer is somewhat uncertain, especially across the risk spectrum. Andruska et al conducted an analysis of the National Cancer Database (NCDB) to evaluate whether EBRT plus BT with or without ADT results in an improvement in overall survival (OS) compared with BT with or without ADT. OS was higher for the EBRT plus BT groups; however, when the ADT + EBRT + BT group was compared with EBRT + BT without ADT group, the improvement in OS was not statistically significant. Overall, the analysis favored EBRT + BT over BT alone, further supporting current guidelines.

Many neurocognitive disorders only present a phenotype after birth. Sukenik-Halevy et al sought to examine the ability to detect prenatal phenotypes in patients with a postnatally diagnosed neurocognitive syndrome and confirmed genetic diagnosis on ES. The team was not able to identify any specific prenatal phenotype associated with their cases of postnatally diagnosed neurocognitive syndromes. The interesting finding of this study is that, of the 122 patients studied, 35.3% (43) had no abnormal sonographic findings that could have been detected prenatally to suggest the need for ES testing. ES is typically used in a prenatal setting for fetuses with anomalies that have a normal KT and CMA. The results of this study raise the question of offering ES to all patients considering diagnostic genetic testing regardless of the indication, as it may be the only way to diagnose some cases of neurocognitive disorders prenatally.

Cell-free fetal DNA (cff DNA) testing for trisomy 21, 18, and 13 has classically be used for high-risk pregnant patients seeking aneuploidy screening. Dar et al sought to examine this type of testing in a low-risk population. They studied, prospectively, the performance of cff DNA testing for trisomy 21, 18, and 13 in both low and high-risk pregnant women with confirmation of results on diagnostic genetic testing. Negative predictive values (NPV) for both the low and high-risk groups were greater than 99.9%. Positive predictive value (PPV) was lower for the low-risk group in comparison to the high-risk group, with it important to note that PPV drops from 96.4% in the high-risk group to 81.8% in the low-risk group for trisomy 21. This means that low-risk patients with a positive result on cff DNA testing are at a higher risk for a false positive than patients at high-risk for an aneuploid fetus. This study shows the mounting evidence that cff DNA can be used in a low-risk population given the high NPV. Providers do still need to note the lower PPV with low-risk population patients and always offer diagnostic genetic testing with any abnormal cff DNA test result.

Many neurocognitive disorders only present a phenotype after birth. Sukenik-Halevy et al sought to examine the ability to detect prenatal phenotypes in patients with a postnatally diagnosed neurocognitive syndrome and confirmed genetic diagnosis on ES. The team was not able to identify any specific prenatal phenotype associated with their cases of postnatally diagnosed neurocognitive syndromes. The interesting finding of this study is that, of the 122 patients studied, 35.3% (43) had no abnormal sonographic findings that could have been detected prenatally to suggest the need for ES testing. ES is typically used in a prenatal setting for fetuses with anomalies that have a normal KT and CMA. The results of this study raise the question of offering ES to all patients considering diagnostic genetic testing regardless of the indication, as it may be the only way to diagnose some cases of neurocognitive disorders prenatally.

Cell-free fetal DNA (cff DNA) testing for trisomy 21, 18, and 13 has classically be used for high-risk pregnant patients seeking aneuploidy screening. Dar et al sought to examine this type of testing in a low-risk population. They studied, prospectively, the performance of cff DNA testing for trisomy 21, 18, and 13 in both low and high-risk pregnant women with confirmation of results on diagnostic genetic testing. Negative predictive values (NPV) for both the low and high-risk groups were greater than 99.9%. Positive predictive value (PPV) was lower for the low-risk group in comparison to the high-risk group, with it important to note that PPV drops from 96.4% in the high-risk group to 81.8% in the low-risk group for trisomy 21. This means that low-risk patients with a positive result on cff DNA testing are at a higher risk for a false positive than patients at high-risk for an aneuploid fetus. This study shows the mounting evidence that cff DNA can be used in a low-risk population given the high NPV. Providers do still need to note the lower PPV with low-risk population patients and always offer diagnostic genetic testing with any abnormal cff DNA test result.

Many neurocognitive disorders only present a phenotype after birth. Sukenik-Halevy et al sought to examine the ability to detect prenatal phenotypes in patients with a postnatally diagnosed neurocognitive syndrome and confirmed genetic diagnosis on ES. The team was not able to identify any specific prenatal phenotype associated with their cases of postnatally diagnosed neurocognitive syndromes. The interesting finding of this study is that, of the 122 patients studied, 35.3% (43) had no abnormal sonographic findings that could have been detected prenatally to suggest the need for ES testing. ES is typically used in a prenatal setting for fetuses with anomalies that have a normal KT and CMA. The results of this study raise the question of offering ES to all patients considering diagnostic genetic testing regardless of the indication, as it may be the only way to diagnose some cases of neurocognitive disorders prenatally.

Cell-free fetal DNA (cff DNA) testing for trisomy 21, 18, and 13 has classically be used for high-risk pregnant patients seeking aneuploidy screening. Dar et al sought to examine this type of testing in a low-risk population. They studied, prospectively, the performance of cff DNA testing for trisomy 21, 18, and 13 in both low and high-risk pregnant women with confirmation of results on diagnostic genetic testing. Negative predictive values (NPV) for both the low and high-risk groups were greater than 99.9%. Positive predictive value (PPV) was lower for the low-risk group in comparison to the high-risk group, with it important to note that PPV drops from 96.4% in the high-risk group to 81.8% in the low-risk group for trisomy 21. This means that low-risk patients with a positive result on cff DNA testing are at a higher risk for a false positive than patients at high-risk for an aneuploid fetus. This study shows the mounting evidence that cff DNA can be used in a low-risk population given the high NPV. Providers do still need to note the lower PPV with low-risk population patients and always offer diagnostic genetic testing with any abnormal cff DNA test result.

To the Editor:

Pretibial myxedema (PTM) is bilateral, nonpitting, scaly thickening and induration of the skin that most commonly occurs on the anterior aspects of the legs and feet. Pretibial myxedema occurs in approximately 0.5% to 4.3% of patients with hyperthyroidism.¹ Thyroid dermopathy often is thought of as the classic nonpitting PTM with skin induration and color change. However, rarer forms of PTM, including plaque, nodular, and elephantiasic, also are important to note.²

Elephantiasic PTM is extremely rare, occurring in less than 1% of patients with PTM.² Elephantiasic PTM is characterized by the persistent swelling of 1 or both legs; thickening of the skin overlying the dorsum of the feet, ankles, and toes; and verrucous irregular plaques that often are fleshy and flattened. The clinical differential diagnosis of elephantiasic PTM includes elephantiasis nostra verrucosa, a late-stage complication of chronic lymphedema that can be related to a variety of infectious or noninfectious obstructive processes. Few effective therapeutic modalities exist in the treatment of elephantiasic PTM. We present a case of elephantiasic PTM.

A 59-year-old man presented to dermatology with leonine facies with pronounced glabellar creases and indentations of the earlobes. He had diffuse woody induration, hyperpigmentation, and nonpitting edema of the lower extremities as well as several flesh-colored exophytic nodules scattered throughout the anterior shins and dorsal feet (Figure 1). On the left posterior calf, there was a large, 3-cm, exophytic, firm, flesh-colored nodule. Examination of the hands revealed mild hyperpigmentation of the distal digits, clubbing of the distal phalanges, and cheiroarthropathy.

The patient was diagnosed with Graves disease after experiencing the classic symptoms of hyperthyroidism, including heat intolerance, tremor, palpitations, and anxiety. He received thyroid ablation and subsequently was supplemented with levothyroxine 75 mg daily. Twelve years later, he was diagnosed with Graves ophthalmopathy with ocular proptosis requiring multiple courses of retro-orbital irradiation and surgical procedures for decompression. Approximately 1 year later, he noted increased swelling, firmness, and darkening of the pretibial surfaces. Initially, he was referred to vascular surgery and underwent bilateral saphenous vein ablation. He also was referred to a lymphedema specialist, and workup revealed an unremarkable lymphatic system. Minimal improvement was noted following the saphenous vein ablation, and he subsequently was referred to dermatology for further workup.

At the current presentation, laboratory analysis revealed a low thyrotropin level (0.03 mIU/L [reference range, 0.4–4.2 mIU/L]), and free thyroxine was within reference range. Radiography of the chest was unremarkable; however, radiography of the hand demonstrated arthrosis of the left fifth proximal interphalangeal joint. Nuclear medicine lymphoscintigraphy and lower extremity ultrasonography were unremarkable. Punch biopsies were performed of the left lateral leg and posterior calf. Hematoxylin and eosin staining demonstrated marked mucin deposition extending to the deep dermis along with deep fibroplasia and was read as consistent with PTM. Colloidal iron highlighted prominent mucin within the dermis (Figure 2).

The patient’s medical history, physical examination, laboratory analysis, imaging, and biopsies were considered, and a diagnosis of elephantiasic PTM was made. Minimal improvement was noted with initial therapeutic interventions including compression therapy and application of super high–potency topical corticosteroids. After further evaluation in our multidisciplinary rheumatology-dermatology clinic, the decision was made to initiate rituximab infusions.

Two months after 1 course of rituximab consisting of two 1000-mg infusions separated by 2 weeks, the patient showed substantial clinical improvement. There was striking improvement of the pretibial surfaces with resolution of the exophytic nodules and improvement of the induration (Figure 3). In addition, there was decreased induration of the glabella and earlobes and decreased fullness of the digital pulp on the hands. The patient also reported subjective improvements in mobility.

Our patient demonstrated all 3 aspects of the Diamond triad: PTM, exophthalmos, and acropachy. Patients present with all 3 features in less than 1% of reported cases of Graves disease.³ Although all 3 features are seen together infrequently, thyroid dermopathy and acropachy often are markers of severe Graves ophthalmopathy. In a study of 114 patients with Graves ophthalmopathy, patients who also had dermopathy and acropachy were more likely to have optic neuropathy or require orbital decompression.⁴

After overcoming the diagnostic dilemma that the elephantiasic presentation of PTM can present, therapeutic management remains a challenge. Heyes et al⁵ documented the successful treatment of highly recalcitrant elephantiasic PTM with rituximab and plasmapheresis therapy. In this case, a 44-year-old woman with an 11-year history of Graves disease and elephantiasic PTM received 29 rituximab infusions and 241 plasmapheresis treatments over the course of 3.5 years. Her elephantiasic PTM clinically resolved, and she was able to resume daily activities and wear normal shoes after being nonambulatory for years.⁵

Rituximab is a monoclonal antibody against CD20, a protein found primarily on the surface of B-cell lymphocytes. Although rituximab initially was approved by the US Food and Drug administration for the treatment of malignant lymphoma, it has had an increasing role in the treatment of autoimmune disorders such as rheumatoid arthritis. Rituximab is postulated to target B lymphocytes and halt their progression to plasma cells. By limiting the population of long-lasting, antibody-producing plasma cells and decreasing the autoantibodies that cause many of the symptoms in Graves disease, rituximab may be an effective therapy to consider in the treatment of elephantiasic PTM.⁶

Although the exact mechanism is poorly understood, PTM likely is a sequela of hyperthyroidism because of the expression of thyroid-stimulating hormone receptor proteins found on normal dermal fibroblasts. Thyroid-stimulating hormone receptor autoantibodies are thought to stimulate these fibroblasts to produce glycosaminoglycans. Histopathologically, accumulation of glycosaminoglycans deposited in the reticular dermis with high concentrations of hyaluronic acid is observed in PTM.⁷

Treatment of elephantiasic PTM remains a therapeutic challenge. Given the rarity of the disease process and limited information on effective therapeutic modalities, rituximab should be viewed as a viable treatment option in the management of recalcitrant elephantiasic PTM.

To the Editor:

Pretibial myxedema (PTM) is bilateral, nonpitting, scaly thickening and induration of the skin that most commonly occurs on the anterior aspects of the legs and feet. Pretibial myxedema occurs in approximately 0.5% to 4.3% of patients with hyperthyroidism.¹ Thyroid dermopathy often is thought of as the classic nonpitting PTM with skin induration and color change. However, rarer forms of PTM, including plaque, nodular, and elephantiasic, also are important to note.²

Elephantiasic PTM is extremely rare, occurring in less than 1% of patients with PTM.² Elephantiasic PTM is characterized by the persistent swelling of 1 or both legs; thickening of the skin overlying the dorsum of the feet, ankles, and toes; and verrucous irregular plaques that often are fleshy and flattened. The clinical differential diagnosis of elephantiasic PTM includes elephantiasis nostra verrucosa, a late-stage complication of chronic lymphedema that can be related to a variety of infectious or noninfectious obstructive processes. Few effective therapeutic modalities exist in the treatment of elephantiasic PTM. We present a case of elephantiasic PTM.

A 59-year-old man presented to dermatology with leonine facies with pronounced glabellar creases and indentations of the earlobes. He had diffuse woody induration, hyperpigmentation, and nonpitting edema of the lower extremities as well as several flesh-colored exophytic nodules scattered throughout the anterior shins and dorsal feet (Figure 1). On the left posterior calf, there was a large, 3-cm, exophytic, firm, flesh-colored nodule. Examination of the hands revealed mild hyperpigmentation of the distal digits, clubbing of the distal phalanges, and cheiroarthropathy.

The patient was diagnosed with Graves disease after experiencing the classic symptoms of hyperthyroidism, including heat intolerance, tremor, palpitations, and anxiety. He received thyroid ablation and subsequently was supplemented with levothyroxine 75 mg daily. Twelve years later, he was diagnosed with Graves ophthalmopathy with ocular proptosis requiring multiple courses of retro-orbital irradiation and surgical procedures for decompression. Approximately 1 year later, he noted increased swelling, firmness, and darkening of the pretibial surfaces. Initially, he was referred to vascular surgery and underwent bilateral saphenous vein ablation. He also was referred to a lymphedema specialist, and workup revealed an unremarkable lymphatic system. Minimal improvement was noted following the saphenous vein ablation, and he subsequently was referred to dermatology for further workup.

At the current presentation, laboratory analysis revealed a low thyrotropin level (0.03 mIU/L [reference range, 0.4–4.2 mIU/L]), and free thyroxine was within reference range. Radiography of the chest was unremarkable; however, radiography of the hand demonstrated arthrosis of the left fifth proximal interphalangeal joint. Nuclear medicine lymphoscintigraphy and lower extremity ultrasonography were unremarkable. Punch biopsies were performed of the left lateral leg and posterior calf. Hematoxylin and eosin staining demonstrated marked mucin deposition extending to the deep dermis along with deep fibroplasia and was read as consistent with PTM. Colloidal iron highlighted prominent mucin within the dermis (Figure 2).

The patient’s medical history, physical examination, laboratory analysis, imaging, and biopsies were considered, and a diagnosis of elephantiasic PTM was made. Minimal improvement was noted with initial therapeutic interventions including compression therapy and application of super high–potency topical corticosteroids. After further evaluation in our multidisciplinary rheumatology-dermatology clinic, the decision was made to initiate rituximab infusions.

Two months after 1 course of rituximab consisting of two 1000-mg infusions separated by 2 weeks, the patient showed substantial clinical improvement. There was striking improvement of the pretibial surfaces with resolution of the exophytic nodules and improvement of the induration (Figure 3). In addition, there was decreased induration of the glabella and earlobes and decreased fullness of the digital pulp on the hands. The patient also reported subjective improvements in mobility.

Our patient demonstrated all 3 aspects of the Diamond triad: PTM, exophthalmos, and acropachy. Patients present with all 3 features in less than 1% of reported cases of Graves disease.³ Although all 3 features are seen together infrequently, thyroid dermopathy and acropachy often are markers of severe Graves ophthalmopathy. In a study of 114 patients with Graves ophthalmopathy, patients who also had dermopathy and acropachy were more likely to have optic neuropathy or require orbital decompression.⁴

After overcoming the diagnostic dilemma that the elephantiasic presentation of PTM can present, therapeutic management remains a challenge. Heyes et al⁵ documented the successful treatment of highly recalcitrant elephantiasic PTM with rituximab and plasmapheresis therapy. In this case, a 44-year-old woman with an 11-year history of Graves disease and elephantiasic PTM received 29 rituximab infusions and 241 plasmapheresis treatments over the course of 3.5 years. Her elephantiasic PTM clinically resolved, and she was able to resume daily activities and wear normal shoes after being nonambulatory for years.⁵

Rituximab is a monoclonal antibody against CD20, a protein found primarily on the surface of B-cell lymphocytes. Although rituximab initially was approved by the US Food and Drug administration for the treatment of malignant lymphoma, it has had an increasing role in the treatment of autoimmune disorders such as rheumatoid arthritis. Rituximab is postulated to target B lymphocytes and halt their progression to plasma cells. By limiting the population of long-lasting, antibody-producing plasma cells and decreasing the autoantibodies that cause many of the symptoms in Graves disease, rituximab may be an effective therapy to consider in the treatment of elephantiasic PTM.⁶

Although the exact mechanism is poorly understood, PTM likely is a sequela of hyperthyroidism because of the expression of thyroid-stimulating hormone receptor proteins found on normal dermal fibroblasts. Thyroid-stimulating hormone receptor autoantibodies are thought to stimulate these fibroblasts to produce glycosaminoglycans. Histopathologically, accumulation of glycosaminoglycans deposited in the reticular dermis with high concentrations of hyaluronic acid is observed in PTM.⁷

Treatment of elephantiasic PTM remains a therapeutic challenge. Given the rarity of the disease process and limited information on effective therapeutic modalities, rituximab should be viewed as a viable treatment option in the management of recalcitrant elephantiasic PTM.

To the Editor:

Pretibial myxedema (PTM) is bilateral, nonpitting, scaly thickening and induration of the skin that most commonly occurs on the anterior aspects of the legs and feet. Pretibial myxedema occurs in approximately 0.5% to 4.3% of patients with hyperthyroidism.¹ Thyroid dermopathy often is thought of as the classic nonpitting PTM with skin induration and color change. However, rarer forms of PTM, including plaque, nodular, and elephantiasic, also are important to note.²

Elephantiasic PTM is extremely rare, occurring in less than 1% of patients with PTM.² Elephantiasic PTM is characterized by the persistent swelling of 1 or both legs; thickening of the skin overlying the dorsum of the feet, ankles, and toes; and verrucous irregular plaques that often are fleshy and flattened. The clinical differential diagnosis of elephantiasic PTM includes elephantiasis nostra verrucosa, a late-stage complication of chronic lymphedema that can be related to a variety of infectious or noninfectious obstructive processes. Few effective therapeutic modalities exist in the treatment of elephantiasic PTM. We present a case of elephantiasic PTM.

A 59-year-old man presented to dermatology with leonine facies with pronounced glabellar creases and indentations of the earlobes. He had diffuse woody induration, hyperpigmentation, and nonpitting edema of the lower extremities as well as several flesh-colored exophytic nodules scattered throughout the anterior shins and dorsal feet (Figure 1). On the left posterior calf, there was a large, 3-cm, exophytic, firm, flesh-colored nodule. Examination of the hands revealed mild hyperpigmentation of the distal digits, clubbing of the distal phalanges, and cheiroarthropathy.

The patient was diagnosed with Graves disease after experiencing the classic symptoms of hyperthyroidism, including heat intolerance, tremor, palpitations, and anxiety. He received thyroid ablation and subsequently was supplemented with levothyroxine 75 mg daily. Twelve years later, he was diagnosed with Graves ophthalmopathy with ocular proptosis requiring multiple courses of retro-orbital irradiation and surgical procedures for decompression. Approximately 1 year later, he noted increased swelling, firmness, and darkening of the pretibial surfaces. Initially, he was referred to vascular surgery and underwent bilateral saphenous vein ablation. He also was referred to a lymphedema specialist, and workup revealed an unremarkable lymphatic system. Minimal improvement was noted following the saphenous vein ablation, and he subsequently was referred to dermatology for further workup.

At the current presentation, laboratory analysis revealed a low thyrotropin level (0.03 mIU/L [reference range, 0.4–4.2 mIU/L]), and free thyroxine was within reference range. Radiography of the chest was unremarkable; however, radiography of the hand demonstrated arthrosis of the left fifth proximal interphalangeal joint. Nuclear medicine lymphoscintigraphy and lower extremity ultrasonography were unremarkable. Punch biopsies were performed of the left lateral leg and posterior calf. Hematoxylin and eosin staining demonstrated marked mucin deposition extending to the deep dermis along with deep fibroplasia and was read as consistent with PTM. Colloidal iron highlighted prominent mucin within the dermis (Figure 2).

The patient’s medical history, physical examination, laboratory analysis, imaging, and biopsies were considered, and a diagnosis of elephantiasic PTM was made. Minimal improvement was noted with initial therapeutic interventions including compression therapy and application of super high–potency topical corticosteroids. After further evaluation in our multidisciplinary rheumatology-dermatology clinic, the decision was made to initiate rituximab infusions.

Two months after 1 course of rituximab consisting of two 1000-mg infusions separated by 2 weeks, the patient showed substantial clinical improvement. There was striking improvement of the pretibial surfaces with resolution of the exophytic nodules and improvement of the induration (Figure 3). In addition, there was decreased induration of the glabella and earlobes and decreased fullness of the digital pulp on the hands. The patient also reported subjective improvements in mobility.

Our patient demonstrated all 3 aspects of the Diamond triad: PTM, exophthalmos, and acropachy. Patients present with all 3 features in less than 1% of reported cases of Graves disease.³ Although all 3 features are seen together infrequently, thyroid dermopathy and acropachy often are markers of severe Graves ophthalmopathy. In a study of 114 patients with Graves ophthalmopathy, patients who also had dermopathy and acropachy were more likely to have optic neuropathy or require orbital decompression.⁴

After overcoming the diagnostic dilemma that the elephantiasic presentation of PTM can present, therapeutic management remains a challenge. Heyes et al⁵ documented the successful treatment of highly recalcitrant elephantiasic PTM with rituximab and plasmapheresis therapy. In this case, a 44-year-old woman with an 11-year history of Graves disease and elephantiasic PTM received 29 rituximab infusions and 241 plasmapheresis treatments over the course of 3.5 years. Her elephantiasic PTM clinically resolved, and she was able to resume daily activities and wear normal shoes after being nonambulatory for years.⁵

Rituximab is a monoclonal antibody against CD20, a protein found primarily on the surface of B-cell lymphocytes. Although rituximab initially was approved by the US Food and Drug administration for the treatment of malignant lymphoma, it has had an increasing role in the treatment of autoimmune disorders such as rheumatoid arthritis. Rituximab is postulated to target B lymphocytes and halt their progression to plasma cells. By limiting the population of long-lasting, antibody-producing plasma cells and decreasing the autoantibodies that cause many of the symptoms in Graves disease, rituximab may be an effective therapy to consider in the treatment of elephantiasic PTM.⁶

Although the exact mechanism is poorly understood, PTM likely is a sequela of hyperthyroidism because of the expression of thyroid-stimulating hormone receptor proteins found on normal dermal fibroblasts. Thyroid-stimulating hormone receptor autoantibodies are thought to stimulate these fibroblasts to produce glycosaminoglycans. Histopathologically, accumulation of glycosaminoglycans deposited in the reticular dermis with high concentrations of hyaluronic acid is observed in PTM.⁷

Treatment of elephantiasic PTM remains a therapeutic challenge. Given the rarity of the disease process and limited information on effective therapeutic modalities, rituximab should be viewed as a viable treatment option in the management of recalcitrant elephantiasic PTM.

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

A new study examining avoidant/restrictive food intake disorder (ARFID) among patients with celiac disease found that the condition is common but is not associated with any difference in disease control. The findings suggest that some with celiac disease may pursue dietary control too far, but experts warn that ARFID is only recently being recognized in patients with GI diseases, the definition is in flux, and it’s important to not overpathologize patient behavior.

The new study, published in Gastro Hep Advances, comes in the wake of a 2021 cross-sectional study, which found that 53.7% of celiac disease patients met the criteria for ARFID based on the Nine-Item ARFID Screen, and were more likely to have anxiety, depression, and reduced food-related quality of life.

chameleonseye/Thinkstock

“I think both studies are hypothesizing that there might be greater fear around eating in these patients with celiac, but that the possible outcomes related to their disease may not actually be different,” said Helen Burton Murray, PhD, director of the GI behavioral health program and staff psychologist at Massachusetts General Hospital, Boston, who was asked to comment on the study.

She also noted that ARFID may represent a subgroup of celiac patients with more severe disease or worse quality of life, though the two studies can’t definitively prove that. The surveys used are intended for screening rather than diagnosis and have not yet been validated in patients with a gastrointestinal disease like celiac.

Although the symptoms of ARFID have been recognized for many years, it only became an official diagnosis with its inclusion in DSM-5 in 2013. Physicians are becoming increasingly aware of this potential comorbidity, but it can be difficult to diagnose or understand the impact of an eating disorder in a condition like celiac disease, where intense dietary management is the key to controlling it. “There’s concern about overpathologizing patients where dietary management can be a normative strategy, and overpathologizing by diagnosing ARFID. Is diagnosing ARFID going to change the patient’s treatment course and improve outcomes for them?” asked Dr. Burton Murray.

In some cases, the answer may be yes. Patients may be so restrictive in their eating that it impacts physical health or lifestyle. “Hypervigilance or worry around eating could extend to even non–gluten based foods. That may be a marker of where a patient’s eating behaviors are crossing the line into ARFID, if their diet is so limited when it doesn’t need to be, and those limitations might be harming them nutritionally, leading to weight loss or making it difficult to live their life in the way that they would like to,” said Dr. Burton Murray.

Still, the results of these studies shouldn’t be overinterpreted, according to Anne R. Lee, EdD, RDN, LD, associate professor of nutritional medicine at the celiac disease center at Columbia University, New York. “In the world of eating disorders, ARFID is the newest kid on the block, and one that’s in transition,” she said. What differentiates ARFID from other eating disorders is that food behavior is related to things like appetite or picky eating, but not body shape and size. Therefore, it helps to combine the ARFID screen with other eating disorder screening tools, Dr. Lee said.

“We need to differentiate between diagnosing someone with a disordered eating pattern versus helping them navigate their life within a gluten-free diet. We need to help them with developing strategies to maneuver through work lunches and social outings and all of those things so that we don’t overdiagnose,” said Dr. Lee.

In the new study, researchers retrospectively analyzed data from 137 patients with celiac disease at the Center for Human Nutrition at Vanderbilt University Medical Center; 107 were women, and the median age was 37 years. The researchers used questionnaires to evaluate diet, including the ARFID Symptom Checklist.

Seventy-eight participants (57%) had suspected ARFID; 30 had symptoms consistent with clinical ARFID and 48 consistent with subclinical ARFID. There were no differences between patients with and without ARFID with respect to anxiety and depression, length of illness, age, gender, body mass index, bone disease, or micronutrient or vitamin deficiency. Serology studies revealed only one difference: a higher frequency of tissue transglutaminase IgG antibody in the ARFID group (15% vs. 2%; P = .007).

There was a strong correlation between ARFID and the Impact of the Gluten Free Diet questionnaire (IGFDQ), with patients scoring higher on the social and food components more likely to also have ARFID. It was also the only predictor of ARFID in a multivariable analysis, with associations in the food (odds ratio, 1.64; P = .01), emotional (OR, 1.66; P = .05), and social (OR, 1.59; P = .01) sections.

The authors concluded that, although there were some study limitations, including possible patient misunderstanding of the survey questions and lack of knowledge of whether the patients had access to gluten-free foods, AFID is not only common, but it also has a significant impact on patients with celiac disease. The authors also noted that this assessment occurred over a 2-year period, with patients attending clinic only once a year. Follow-up surveys, duodenal biopsies, and bone density assessments could identify more differences over time.

Dr. Burton Murray and Dr. Lee have no relevant financial disclosures.

The calls kept coming into the National Runaway Safeline during the pandemic: the desperate kids who wanted to bike away from home in the middle of the night, the isolated youths who felt suicidal, the teens whose parents had forced them out of the house.

To the surprise of experts who help runaway youths, the pandemic didn’t appear to produce a big rise or fall in the numbers of children and teens who had left home. Still, the crisis hit hard. As schools closed and households sheltered in place, youths reached out to the National Runaway Safeline to report heightened family conflicts and worsening mental health.

The Safeline, based in Chicago, is the country’s 24/7, federally designated communications system for runaway and homeless youths. Each year, it makes about 125,000 connections with young people and their family members through its hotline and other services.

In a typical year, teens aged 15-17 years are the main group that gets in touch by phone, live chat, email, or an online crisis forum, according to Jeff Stern, chief engagement officer at the Safeline.

But in the past 2 years, “contacts have skewed younger,” including many more children under age 12.

“I think this is showing what a hit this is taking on young children,” he said.

Without school, sports, and other activities, younger children might be reaching out because they’ve lost trusted sources of support. Callers have been as young as 9.

“Those ones stand out,” said a crisis center supervisor who asked to go by Michael, which is not his real name, to protect the privacy of his clients.

In November 2020, a child posted in the crisis forum: “I’m 11 and my parents treat me poorly. They have told me many times to ‘kill myself’ and I didn’t let that settle well with me. ... I have tried to run away one time from my house, but they found out, so they took my phone away and put screws on my windows so I couldn’t leave.”

Increasing numbers of children told Safeline counselors that their parents were emotionally or verbally abusive, while others reported physical abuse. Some said they experienced neglect, while others had been thrown out.

“We absolutely have had youths who have either been physically kicked out of the house or just verbally told to leave,” Michael said, “and then the kid does.”
 

Heightened family conflicts

The Safeline partners with the National Center for Missing and Exploited Children, which, despite widespread public perception, doesn’t work mainly with child abduction cases. Each year, the center assists with 29,000-31,000 cases, and 92% involve “endangered runaways,” said John Bischoff, vice president of the Missing Children Division. These children could be running away from home or foster care.

During the pandemic, the center didn’t spot major changes in its missing child numbers, “which honestly was shocking,” Mr. Bischoff said. “We figured we were either going to see an extreme rise or a decrease.

“But the reasons for the run were changing,” he said.

Many youths were fleeing out of frustration with quarantine restrictions, Mr. Bischoff said, as well as frustration with the unknown and their own lack of control over many situations.

At the runaway hotline, calls have been longer and more intense, with family problems topping the list of concerns. In 2019, about 57% of all contacts mentioned family dynamics. In 2020, that number jumped to 88%, according to Mr. Stern.

Some kids sought support for family problems that involved school. In October 2020, one 13-year-old wrote in the Safeline forum: “My mom constantly yells at me for no reason. I want to leave, but I don’t know how. I have also been really stressed about school because they haven’t been giving me the grades I would normally receive during actual school. She thinks I’m lying and that I don’t care. I just need somebody to help me.”

Many adults are under tremendous strain, too, Michael said.

“Parents might have gotten COVID last month and haven’t been able to work for 2 weeks, and they’re missing a paycheck now. Money is tight, there might not be food, everyone’s angry at everything.”

During the pandemic, the National Runaway Safeline found a 16% increase in contacts citing financial challenges.

Some children have felt confined in unsafe homes or have endured violence, as one 15-year-old reported in the forum: “I am the scapegoat out of four kids. Unfortunately, my mom has always been a toxic person. ... I’m the only kid she still hits really hard. She’s left bruises and scratches recently. ... I just have no solution to this.”
 

Worsening mental health

Besides family dynamics, mental health emerged as a top concern that youths reported in 2020. “This is something notable. It increased by 30% just in 1 year,” Mr. Stern said.

In November 2020, a 16-year-old wrote: “I can’t ever go outside. I’ve been stuck in the house for a very long time now since quarantine started. I’m scared. ... My mother has been taking her anger out on me emotionally. ... I have severe depression and I need help. Please, if there’s any way I can get out of here, let me know.”

The Safeline also has seen a rise in suicide-related contacts. Among children and teens who had cited a mental health concern, 18% said they were suicidal, Stern said. Most were between ages 12 and 16, but some were younger than 12.

When children couldn’t hang out with peers, they felt even more isolated if parents confiscated their phones, a common punishment, Michael said.

During the winter of 2020-21, “It felt like almost every digital contact was a youth reaching out on their Chromebook because they had gotten their phone taken away and they were either suicidal or considering running away,” he said. “That’s kind of their entire social sphere getting taken away.”
 

Reality check

Roughly 7 in 10 youths report still being at home when they reach out to the Safeline. Among those who do leave, Michael said, “They’re going sometimes to friends’ houses, oftentimes to a significant other’s house, sometimes to extended family members’ houses. Often, they don’t have a place that they’re planning to go. They just left, and that’s why they’re calling us.”

While some youths have been afraid of catching COVID-19 in general, the coronavirus threat hasn’t deterred those who have decided to run away, Michael said. “Usually, they’re more worried about being returned home.”

Many can’t comprehend the risks of setting off on their own.

In October 2021, a 15-year-old boy posted on the forum that his verbally abusive parents had called him a mistake and said they couldn’t wait for him to move out.

“So I’m going to make their dreams come true,” he wrote. “I’m going to go live in California with my friend who is a young YouTuber. I need help getting money to either fly or get a bus ticket, even though I’m all right with trying to ride a bike or fixing my dirt bike and getting the wagon to pull my stuff. But I’m looking for apartments in Los Angeles so I’m not living on the streets and I’m looking for a job. Please help me. My friend can’t send me money because I don’t have a bank account.”

“Often,” Michael said, “we’re reality-checking kids who want to hitchhike 5 hours away to either a friend’s or the closest shelter that we could find them. Or walk for 5 hours at 3 a.m. or bike, so we try to safety-check that.”

Another concern: online enticement by predators. During the pandemic, the National Center for Missing and Exploited Children saw cases in which children ran away from home “to go meet with someone who may not be who they thought they were talking to online,” Mr. Bischoff said. “It’s certainly something we’re keeping a close eye on.”
 

Fewer resources in the pandemic

The National Runaway Safeline provides information and referrals to other hotlines and services, including suicide prevention and mental health organizations. When youths have already run away and have no place to go, Michael said, the Safeline tries to find shelter options or seek out a relative who can provide a safe place to stay.

But finding shelters became tougher during the pandemic, when many had no room or shelter supply was limited. Some had to shut down for COVID-19–related deep cleanings, Michael said. Helping youths find transportation, especially with public transportation shutdowns, also was tough.

The Huckleberry House, a six-bed youth shelter in San Francisco, has stayed open throughout the pandemic with limited staffing, said Douglas Styles, PsyD. He’s the executive director of the Huckleberry Youth Programs, which runs the house.

The shelter, which serves Bay Area runaway and homeless youths ages 12-17, hasn’t seen an overall spike in demand, Dr. Styles said. But “what’s expanded is undocumented [youths] and young people who don’t have any family connections in the area, so they’re unaccompanied as well. We’ve seen that here and there throughout the years, but during the pandemic, that population has actually increased quite a bit.”

The Huckleberry House has sheltered children and teens who have run away from all kinds of homes, including affluent ones, Dr. Styles said.

Once children leave home, the lack of adult supervision leaves them vulnerable. They face multiple dangers, including child sex trafficking and exploitation, substance abuse, gang involvement, and violence. “As an organization, that scares us,” Mr. Bischoff said. “What’s happening at home, we’ll sort that out. The biggest thing we as an organization are trying to do is locate them and ensure their safety.”

To help runaways and their families get in touch, the National Runaway Safeline provides a message service and conference calling. “We can play the middleman, really acting on behalf of the young person – not because they’re right or wrong, but to ensure that their voice is really heard,” Mr. Stern said.

Through its national Home Free program, the Safeline partners with Greyhound to bring children back home or into an alternative, safe living environment by providing a free bus ticket.

These days, technology can expose children to harm online, but it can also speed their return home.

“When I was growing up, if you weren’t home by 5 o’clock, Mom would start to worry, but she really didn’t have any way of reaching you,” Mr. Bischoff said. “More children today have cellphones. More children are easily reachable. That’s a benefit.”

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

The calls kept coming into the National Runaway Safeline during the pandemic: the desperate kids who wanted to bike away from home in the middle of the night, the isolated youths who felt suicidal, the teens whose parents had forced them out of the house.

To the surprise of experts who help runaway youths, the pandemic didn’t appear to produce a big rise or fall in the numbers of children and teens who had left home. Still, the crisis hit hard. As schools closed and households sheltered in place, youths reached out to the National Runaway Safeline to report heightened family conflicts and worsening mental health.

The Safeline, based in Chicago, is the country’s 24/7, federally designated communications system for runaway and homeless youths. Each year, it makes about 125,000 connections with young people and their family members through its hotline and other services.

In a typical year, teens aged 15-17 years are the main group that gets in touch by phone, live chat, email, or an online crisis forum, according to Jeff Stern, chief engagement officer at the Safeline.

But in the past 2 years, “contacts have skewed younger,” including many more children under age 12.

“I think this is showing what a hit this is taking on young children,” he said.

Without school, sports, and other activities, younger children might be reaching out because they’ve lost trusted sources of support. Callers have been as young as 9.

“Those ones stand out,” said a crisis center supervisor who asked to go by Michael, which is not his real name, to protect the privacy of his clients.

In November 2020, a child posted in the crisis forum: “I’m 11 and my parents treat me poorly. They have told me many times to ‘kill myself’ and I didn’t let that settle well with me. ... I have tried to run away one time from my house, but they found out, so they took my phone away and put screws on my windows so I couldn’t leave.”

Increasing numbers of children told Safeline counselors that their parents were emotionally or verbally abusive, while others reported physical abuse. Some said they experienced neglect, while others had been thrown out.

“We absolutely have had youths who have either been physically kicked out of the house or just verbally told to leave,” Michael said, “and then the kid does.”
 

Heightened family conflicts

The Safeline partners with the National Center for Missing and Exploited Children, which, despite widespread public perception, doesn’t work mainly with child abduction cases. Each year, the center assists with 29,000-31,000 cases, and 92% involve “endangered runaways,” said John Bischoff, vice president of the Missing Children Division. These children could be running away from home or foster care.

During the pandemic, the center didn’t spot major changes in its missing child numbers, “which honestly was shocking,” Mr. Bischoff said. “We figured we were either going to see an extreme rise or a decrease.

“But the reasons for the run were changing,” he said.

Many youths were fleeing out of frustration with quarantine restrictions, Mr. Bischoff said, as well as frustration with the unknown and their own lack of control over many situations.

At the runaway hotline, calls have been longer and more intense, with family problems topping the list of concerns. In 2019, about 57% of all contacts mentioned family dynamics. In 2020, that number jumped to 88%, according to Mr. Stern.

Some kids sought support for family problems that involved school. In October 2020, one 13-year-old wrote in the Safeline forum: “My mom constantly yells at me for no reason. I want to leave, but I don’t know how. I have also been really stressed about school because they haven’t been giving me the grades I would normally receive during actual school. She thinks I’m lying and that I don’t care. I just need somebody to help me.”

Many adults are under tremendous strain, too, Michael said.

“Parents might have gotten COVID last month and haven’t been able to work for 2 weeks, and they’re missing a paycheck now. Money is tight, there might not be food, everyone’s angry at everything.”

During the pandemic, the National Runaway Safeline found a 16% increase in contacts citing financial challenges.

Some children have felt confined in unsafe homes or have endured violence, as one 15-year-old reported in the forum: “I am the scapegoat out of four kids. Unfortunately, my mom has always been a toxic person. ... I’m the only kid she still hits really hard. She’s left bruises and scratches recently. ... I just have no solution to this.”
 

Worsening mental health

Besides family dynamics, mental health emerged as a top concern that youths reported in 2020. “This is something notable. It increased by 30% just in 1 year,” Mr. Stern said.

In November 2020, a 16-year-old wrote: “I can’t ever go outside. I’ve been stuck in the house for a very long time now since quarantine started. I’m scared. ... My mother has been taking her anger out on me emotionally. ... I have severe depression and I need help. Please, if there’s any way I can get out of here, let me know.”

The Safeline also has seen a rise in suicide-related contacts. Among children and teens who had cited a mental health concern, 18% said they were suicidal, Stern said. Most were between ages 12 and 16, but some were younger than 12.

When children couldn’t hang out with peers, they felt even more isolated if parents confiscated their phones, a common punishment, Michael said.

During the winter of 2020-21, “It felt like almost every digital contact was a youth reaching out on their Chromebook because they had gotten their phone taken away and they were either suicidal or considering running away,” he said. “That’s kind of their entire social sphere getting taken away.”
 

Reality check

Roughly 7 in 10 youths report still being at home when they reach out to the Safeline. Among those who do leave, Michael said, “They’re going sometimes to friends’ houses, oftentimes to a significant other’s house, sometimes to extended family members’ houses. Often, they don’t have a place that they’re planning to go. They just left, and that’s why they’re calling us.”

While some youths have been afraid of catching COVID-19 in general, the coronavirus threat hasn’t deterred those who have decided to run away, Michael said. “Usually, they’re more worried about being returned home.”

Many can’t comprehend the risks of setting off on their own.

In October 2021, a 15-year-old boy posted on the forum that his verbally abusive parents had called him a mistake and said they couldn’t wait for him to move out.

“So I’m going to make their dreams come true,” he wrote. “I’m going to go live in California with my friend who is a young YouTuber. I need help getting money to either fly or get a bus ticket, even though I’m all right with trying to ride a bike or fixing my dirt bike and getting the wagon to pull my stuff. But I’m looking for apartments in Los Angeles so I’m not living on the streets and I’m looking for a job. Please help me. My friend can’t send me money because I don’t have a bank account.”

“Often,” Michael said, “we’re reality-checking kids who want to hitchhike 5 hours away to either a friend’s or the closest shelter that we could find them. Or walk for 5 hours at 3 a.m. or bike, so we try to safety-check that.”

Another concern: online enticement by predators. During the pandemic, the National Center for Missing and Exploited Children saw cases in which children ran away from home “to go meet with someone who may not be who they thought they were talking to online,” Mr. Bischoff said. “It’s certainly something we’re keeping a close eye on.”
 

Fewer resources in the pandemic

The National Runaway Safeline provides information and referrals to other hotlines and services, including suicide prevention and mental health organizations. When youths have already run away and have no place to go, Michael said, the Safeline tries to find shelter options or seek out a relative who can provide a safe place to stay.

But finding shelters became tougher during the pandemic, when many had no room or shelter supply was limited. Some had to shut down for COVID-19–related deep cleanings, Michael said. Helping youths find transportation, especially with public transportation shutdowns, also was tough.

The Huckleberry House, a six-bed youth shelter in San Francisco, has stayed open throughout the pandemic with limited staffing, said Douglas Styles, PsyD. He’s the executive director of the Huckleberry Youth Programs, which runs the house.

The shelter, which serves Bay Area runaway and homeless youths ages 12-17, hasn’t seen an overall spike in demand, Dr. Styles said. But “what’s expanded is undocumented [youths] and young people who don’t have any family connections in the area, so they’re unaccompanied as well. We’ve seen that here and there throughout the years, but during the pandemic, that population has actually increased quite a bit.”

The Huckleberry House has sheltered children and teens who have run away from all kinds of homes, including affluent ones, Dr. Styles said.

Once children leave home, the lack of adult supervision leaves them vulnerable. They face multiple dangers, including child sex trafficking and exploitation, substance abuse, gang involvement, and violence. “As an organization, that scares us,” Mr. Bischoff said. “What’s happening at home, we’ll sort that out. The biggest thing we as an organization are trying to do is locate them and ensure their safety.”

To help runaways and their families get in touch, the National Runaway Safeline provides a message service and conference calling. “We can play the middleman, really acting on behalf of the young person – not because they’re right or wrong, but to ensure that their voice is really heard,” Mr. Stern said.

Through its national Home Free program, the Safeline partners with Greyhound to bring children back home or into an alternative, safe living environment by providing a free bus ticket.

These days, technology can expose children to harm online, but it can also speed their return home.

“When I was growing up, if you weren’t home by 5 o’clock, Mom would start to worry, but she really didn’t have any way of reaching you,” Mr. Bischoff said. “More children today have cellphones. More children are easily reachable. That’s a benefit.”

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

The calls kept coming into the National Runaway Safeline during the pandemic: the desperate kids who wanted to bike away from home in the middle of the night, the isolated youths who felt suicidal, the teens whose parents had forced them out of the house.

To the surprise of experts who help runaway youths, the pandemic didn’t appear to produce a big rise or fall in the numbers of children and teens who had left home. Still, the crisis hit hard. As schools closed and households sheltered in place, youths reached out to the National Runaway Safeline to report heightened family conflicts and worsening mental health.

The Safeline, based in Chicago, is the country’s 24/7, federally designated communications system for runaway and homeless youths. Each year, it makes about 125,000 connections with young people and their family members through its hotline and other services.

In a typical year, teens aged 15-17 years are the main group that gets in touch by phone, live chat, email, or an online crisis forum, according to Jeff Stern, chief engagement officer at the Safeline.

But in the past 2 years, “contacts have skewed younger,” including many more children under age 12.

“I think this is showing what a hit this is taking on young children,” he said.

Without school, sports, and other activities, younger children might be reaching out because they’ve lost trusted sources of support. Callers have been as young as 9.

“Those ones stand out,” said a crisis center supervisor who asked to go by Michael, which is not his real name, to protect the privacy of his clients.

In November 2020, a child posted in the crisis forum: “I’m 11 and my parents treat me poorly. They have told me many times to ‘kill myself’ and I didn’t let that settle well with me. ... I have tried to run away one time from my house, but they found out, so they took my phone away and put screws on my windows so I couldn’t leave.”

Increasing numbers of children told Safeline counselors that their parents were emotionally or verbally abusive, while others reported physical abuse. Some said they experienced neglect, while others had been thrown out.

“We absolutely have had youths who have either been physically kicked out of the house or just verbally told to leave,” Michael said, “and then the kid does.”
 

Heightened family conflicts

The Safeline partners with the National Center for Missing and Exploited Children, which, despite widespread public perception, doesn’t work mainly with child abduction cases. Each year, the center assists with 29,000-31,000 cases, and 92% involve “endangered runaways,” said John Bischoff, vice president of the Missing Children Division. These children could be running away from home or foster care.

During the pandemic, the center didn’t spot major changes in its missing child numbers, “which honestly was shocking,” Mr. Bischoff said. “We figured we were either going to see an extreme rise or a decrease.

“But the reasons for the run were changing,” he said.

Many youths were fleeing out of frustration with quarantine restrictions, Mr. Bischoff said, as well as frustration with the unknown and their own lack of control over many situations.

At the runaway hotline, calls have been longer and more intense, with family problems topping the list of concerns. In 2019, about 57% of all contacts mentioned family dynamics. In 2020, that number jumped to 88%, according to Mr. Stern.

Some kids sought support for family problems that involved school. In October 2020, one 13-year-old wrote in the Safeline forum: “My mom constantly yells at me for no reason. I want to leave, but I don’t know how. I have also been really stressed about school because they haven’t been giving me the grades I would normally receive during actual school. She thinks I’m lying and that I don’t care. I just need somebody to help me.”

Many adults are under tremendous strain, too, Michael said.

“Parents might have gotten COVID last month and haven’t been able to work for 2 weeks, and they’re missing a paycheck now. Money is tight, there might not be food, everyone’s angry at everything.”

During the pandemic, the National Runaway Safeline found a 16% increase in contacts citing financial challenges.

Some children have felt confined in unsafe homes or have endured violence, as one 15-year-old reported in the forum: “I am the scapegoat out of four kids. Unfortunately, my mom has always been a toxic person. ... I’m the only kid she still hits really hard. She’s left bruises and scratches recently. ... I just have no solution to this.”
 

Worsening mental health

Besides family dynamics, mental health emerged as a top concern that youths reported in 2020. “This is something notable. It increased by 30% just in 1 year,” Mr. Stern said.

In November 2020, a 16-year-old wrote: “I can’t ever go outside. I’ve been stuck in the house for a very long time now since quarantine started. I’m scared. ... My mother has been taking her anger out on me emotionally. ... I have severe depression and I need help. Please, if there’s any way I can get out of here, let me know.”

The Safeline also has seen a rise in suicide-related contacts. Among children and teens who had cited a mental health concern, 18% said they were suicidal, Stern said. Most were between ages 12 and 16, but some were younger than 12.

When children couldn’t hang out with peers, they felt even more isolated if parents confiscated their phones, a common punishment, Michael said.

During the winter of 2020-21, “It felt like almost every digital contact was a youth reaching out on their Chromebook because they had gotten their phone taken away and they were either suicidal or considering running away,” he said. “That’s kind of their entire social sphere getting taken away.”
 

Reality check

Roughly 7 in 10 youths report still being at home when they reach out to the Safeline. Among those who do leave, Michael said, “They’re going sometimes to friends’ houses, oftentimes to a significant other’s house, sometimes to extended family members’ houses. Often, they don’t have a place that they’re planning to go. They just left, and that’s why they’re calling us.”

While some youths have been afraid of catching COVID-19 in general, the coronavirus threat hasn’t deterred those who have decided to run away, Michael said. “Usually, they’re more worried about being returned home.”

Many can’t comprehend the risks of setting off on their own.

In October 2021, a 15-year-old boy posted on the forum that his verbally abusive parents had called him a mistake and said they couldn’t wait for him to move out.

“So I’m going to make their dreams come true,” he wrote. “I’m going to go live in California with my friend who is a young YouTuber. I need help getting money to either fly or get a bus ticket, even though I’m all right with trying to ride a bike or fixing my dirt bike and getting the wagon to pull my stuff. But I’m looking for apartments in Los Angeles so I’m not living on the streets and I’m looking for a job. Please help me. My friend can’t send me money because I don’t have a bank account.”

“Often,” Michael said, “we’re reality-checking kids who want to hitchhike 5 hours away to either a friend’s or the closest shelter that we could find them. Or walk for 5 hours at 3 a.m. or bike, so we try to safety-check that.”

Another concern: online enticement by predators. During the pandemic, the National Center for Missing and Exploited Children saw cases in which children ran away from home “to go meet with someone who may not be who they thought they were talking to online,” Mr. Bischoff said. “It’s certainly something we’re keeping a close eye on.”
 

Fewer resources in the pandemic

The National Runaway Safeline provides information and referrals to other hotlines and services, including suicide prevention and mental health organizations. When youths have already run away and have no place to go, Michael said, the Safeline tries to find shelter options or seek out a relative who can provide a safe place to stay.

But finding shelters became tougher during the pandemic, when many had no room or shelter supply was limited. Some had to shut down for COVID-19–related deep cleanings, Michael said. Helping youths find transportation, especially with public transportation shutdowns, also was tough.

The Huckleberry House, a six-bed youth shelter in San Francisco, has stayed open throughout the pandemic with limited staffing, said Douglas Styles, PsyD. He’s the executive director of the Huckleberry Youth Programs, which runs the house.

The shelter, which serves Bay Area runaway and homeless youths ages 12-17, hasn’t seen an overall spike in demand, Dr. Styles said. But “what’s expanded is undocumented [youths] and young people who don’t have any family connections in the area, so they’re unaccompanied as well. We’ve seen that here and there throughout the years, but during the pandemic, that population has actually increased quite a bit.”

The Huckleberry House has sheltered children and teens who have run away from all kinds of homes, including affluent ones, Dr. Styles said.

Once children leave home, the lack of adult supervision leaves them vulnerable. They face multiple dangers, including child sex trafficking and exploitation, substance abuse, gang involvement, and violence. “As an organization, that scares us,” Mr. Bischoff said. “What’s happening at home, we’ll sort that out. The biggest thing we as an organization are trying to do is locate them and ensure their safety.”

To help runaways and their families get in touch, the National Runaway Safeline provides a message service and conference calling. “We can play the middleman, really acting on behalf of the young person – not because they’re right or wrong, but to ensure that their voice is really heard,” Mr. Stern said.

Through its national Home Free program, the Safeline partners with Greyhound to bring children back home or into an alternative, safe living environment by providing a free bus ticket.

These days, technology can expose children to harm online, but it can also speed their return home.

“When I was growing up, if you weren’t home by 5 o’clock, Mom would start to worry, but she really didn’t have any way of reaching you,” Mr. Bischoff said. “More children today have cellphones. More children are easily reachable. That’s a benefit.”

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

A Florida jury has found a Palm Beach psychiatrist guilty of one count of conspiracy to commit healthcare fraud and wire fraud and 11 counts of healthcare fraud.

Mark Agresti, MD, 59, was convicted of unlawfully billing approximately $110 million of medically unnecessary urinalysis services for patients living at Good Decisions Sober Living (GDSL), a drug rehabilitation facility in West Palm Beach, Fla. Dr. Agresti was once the director of psychiatry at the former Columbia Hospital in West Palm Beach.

According to evidence presented at the trial, Dr. Agresti, as medical director of GDSL, agreed to provide standing orders for urinalysis for GDSL patients in exchange for a monthly fee. Three to four times a week, patients were required to submit to excessive and medically unnecessary urine tests, costing $6,000 to $9,000 per test, according to federal officials. Dr. Agresti did not review the results of these tests and did not use the tests to treat patients. The evidence also showed that he had also done this at other addiction facilities in the West Palm Beach area, resulting in thousands of additional fraudulent tests. Dr. Agresti had GDSL patients visit his private practice so he could fraudulently bill for services there as well.

“This defendant used his medical license to facilitate an egregious, multimillion-dollar fraud scheme that exploited vulnerable substance abusers,” said Juan Antonio Gonzalez, U.S. Attorney for the Southern District of Florida, in a statement announcing the conviction.

Three other defendants, including GDSL’s owner, Kenneth Bailynson, were previously indicted and pleaded guilty to related charges connected with the scheme. Dr. Agresti, however, insisted on his innocence throughout the trial, arguing that he was himself the victim of Mr. Bailynson. Mr. Bailynson, as a part of his plea deal, testified against Dr. Agresti at the trial.

According to a report in the Palm Beach Post, Dr. Agresti’s lawyers, in closing statements, argued, “The government did a fantastic job of proving that Dr. Agresti was negligent, maybe even grossly negligent, but that’s not the issue in this case.” The jury disagreed.

Dr. Agresti faces a maximum penalty of 20 years in prison for the healthcare fraud and wire fraud conspiracy charges and 10 years for each count of healthcare fraud. Sentencing is scheduled for April 21.
 

Ten people, including two physicians, charged in Texas kickback scheme

Jose Maldonado, MD, 48, a family medicine physician, and Eduardo Carlos Canova, MD, 44, an internal medicine specialist, both based in Laredo, Tex., were among ten people indicted in connection with a $300 million healthcare fraud scheme

According to the federal indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs, LLC, allegedly paid kickbacks to medical practitioners in exchange for orders for medically unnecessary lab tests, which were then billed to Medicare and other federal healthcare programs. The medical professionals, including Dr. Maldonado and Dr. Canova, are alleged to have accepted bribes for ordering millions of dollars’ worth of tests.

The scheme was facilitated by marketing firms, which paid doctors hundreds of thousands of dollars for “advisory services,” according to officials. Rather than providing advice, however, the physicians provided lab test referrals. The labs are accused of paying portions of the salaries of the doctors’ staffs as well as portions of their leases. In some instances, direct payments were made to the practitioner’s spouse. In one case, the labs informed one practitioner that the payments would cease if he didn’t refer more tests. He responded to the threat by immediately increasing his lab referrals, averaging 20 to 30 referrals a day.

Jeffrey Madison, the founder of Spectrum and Unified, is accused of convincing Reliable’s founders to convert their business to a physician-owned lab to disguise the kickbacks. Reliable offered physicians ownership opportunities only if they referred enough lab tests. In some cases, says the indictment, the labs made advance payments to physicians to ensure that those physicians would not send samples to other labs.

The scheme resulted in more than $300 million in billing to federal government healthcare programs. Between 2015 and 2018, Dr. Maldonado alone received more than $400,000 in kickbacks for ordering more than $4 million worth of lab tests, and Dr. Canova received more than $300,000 for ordering more than $12 million in tests, according to the indictment.

The 26-count indictment included charges of conspiracy to commit healthcare fraud, conspiracy to pay and receive healthcare kickbacks, offering or paying illegal kickbacks, and soliciting or receiving illegal kickbacks.
 

N.J. doc charged on 34 counts of illegally prescribing controlled substances

A N.J. orthopedic surgeon has been charged with 34 counts of illegally prescribing controlled substances.

According to documents filed in the case, from November 2016 to February 2018 Evangelos Megariotis, MD, 68, of Passaic County, N.J., prescribed opiates — including oxycodone, alprazolam (Xanax), and cough syrup with codeine — as well as stimulants without a legitimate medical purpose and outside the usual course of his practice.

Before the State of New Jersey permanently banned him from practicing medicine, Dr. Megariotis owned and operated Clifton Orthopedic Associates, in Clifton, N.J.

According to The Bergin Record, the state alleges that Dr. Megariotis prescribed thousands of doses of painkillers even though he knew his patients were abusing them and in some cases were getting similar drugs from other doctors. In addition, Dr. Megariotis failed to diagnose or treat these patients’ underlying conditions, treated illnesses outside his scope of practice, and performed surgery in the absence of medical need.

If convicted, Dr. Megariotis could face a lengthy prison sentence as well as substantial fines. The counts of illegally prescribing Schedule II opioids and stimulants are punishable by a maximum of 20 years in prison and a $1 million fine. Illegally prescribing Schedule IV controlled substances brings a maximum of 5 years in prison and a $250,000 fine. The counts of illegally prescribing cough syrup with codeine, a Schedule V controlled substance, are punishable by a maximum of 1 year in prison and a $100,000 fine.
 

Michigan surgeon pleads guilty to fraud scheme

A Bay City, Mich., vascular surgeon has pleaded guilty to engaging in a scheme to defraud Medicare, Medicaid, and Blue Cross/Blue Shield of Michigan out of approximately $19.5 million

According to the plea agreement, in 2009, Vasso Godiali, MD, 59, began false and fraudulent billing to the three insurers. False claims included billing for the placement of stents in dialysis patients and for the treatment of arterial blood clots. The surgeon admitted to billing for the placement of multiple stents in the same vessel and preparing medical records to support the necessity of placing those stents. However, he never placed the stents.

In the plea document, Dr. Godiali also admitted that his medical records would describe occluded arteries that would justify arterial thrombectomies. However, in many cases, there were no occluded arteries, and no thrombectomies were performed, even though Dr. Godiali billed insurers for them.

“When Dr Godiali submitted claims for medical services that were never provided, he violated the trust of his patients and defrauded taxpayer-funded health care programs,” Mario M. Pinto, special agent in charge, said in a statement announcing the plea.

In 2014, The Bay City Times interviewed Dr. Godiali after he was featured by USA Today as one of seven physicians in the United States to receive more than $10 million for Medicare reimbursements in 2012. He told The Times he was a workaholic. “I work a lot — I work probably more than surgeons that you meet,” he told the paper.

Dr. Godiali faces up to 10 years in prison. In addition, he will be required to pay $19.5 million in restitution to the three insurers. A civil forfeiture case against approximately $39.9 million seized from accounts controlled by Dr. Godiali is pending. Sentencing is scheduled for September 15.

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

A Florida jury has found a Palm Beach psychiatrist guilty of one count of conspiracy to commit healthcare fraud and wire fraud and 11 counts of healthcare fraud.

Mark Agresti, MD, 59, was convicted of unlawfully billing approximately $110 million of medically unnecessary urinalysis services for patients living at Good Decisions Sober Living (GDSL), a drug rehabilitation facility in West Palm Beach, Fla. Dr. Agresti was once the director of psychiatry at the former Columbia Hospital in West Palm Beach.

According to evidence presented at the trial, Dr. Agresti, as medical director of GDSL, agreed to provide standing orders for urinalysis for GDSL patients in exchange for a monthly fee. Three to four times a week, patients were required to submit to excessive and medically unnecessary urine tests, costing $6,000 to $9,000 per test, according to federal officials. Dr. Agresti did not review the results of these tests and did not use the tests to treat patients. The evidence also showed that he had also done this at other addiction facilities in the West Palm Beach area, resulting in thousands of additional fraudulent tests. Dr. Agresti had GDSL patients visit his private practice so he could fraudulently bill for services there as well.

“This defendant used his medical license to facilitate an egregious, multimillion-dollar fraud scheme that exploited vulnerable substance abusers,” said Juan Antonio Gonzalez, U.S. Attorney for the Southern District of Florida, in a statement announcing the conviction.

Three other defendants, including GDSL’s owner, Kenneth Bailynson, were previously indicted and pleaded guilty to related charges connected with the scheme. Dr. Agresti, however, insisted on his innocence throughout the trial, arguing that he was himself the victim of Mr. Bailynson. Mr. Bailynson, as a part of his plea deal, testified against Dr. Agresti at the trial.

According to a report in the Palm Beach Post, Dr. Agresti’s lawyers, in closing statements, argued, “The government did a fantastic job of proving that Dr. Agresti was negligent, maybe even grossly negligent, but that’s not the issue in this case.” The jury disagreed.

Dr. Agresti faces a maximum penalty of 20 years in prison for the healthcare fraud and wire fraud conspiracy charges and 10 years for each count of healthcare fraud. Sentencing is scheduled for April 21.
 

Ten people, including two physicians, charged in Texas kickback scheme

Jose Maldonado, MD, 48, a family medicine physician, and Eduardo Carlos Canova, MD, 44, an internal medicine specialist, both based in Laredo, Tex., were among ten people indicted in connection with a $300 million healthcare fraud scheme

According to the federal indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs, LLC, allegedly paid kickbacks to medical practitioners in exchange for orders for medically unnecessary lab tests, which were then billed to Medicare and other federal healthcare programs. The medical professionals, including Dr. Maldonado and Dr. Canova, are alleged to have accepted bribes for ordering millions of dollars’ worth of tests.

The scheme was facilitated by marketing firms, which paid doctors hundreds of thousands of dollars for “advisory services,” according to officials. Rather than providing advice, however, the physicians provided lab test referrals. The labs are accused of paying portions of the salaries of the doctors’ staffs as well as portions of their leases. In some instances, direct payments were made to the practitioner’s spouse. In one case, the labs informed one practitioner that the payments would cease if he didn’t refer more tests. He responded to the threat by immediately increasing his lab referrals, averaging 20 to 30 referrals a day.

Jeffrey Madison, the founder of Spectrum and Unified, is accused of convincing Reliable’s founders to convert their business to a physician-owned lab to disguise the kickbacks. Reliable offered physicians ownership opportunities only if they referred enough lab tests. In some cases, says the indictment, the labs made advance payments to physicians to ensure that those physicians would not send samples to other labs.

The scheme resulted in more than $300 million in billing to federal government healthcare programs. Between 2015 and 2018, Dr. Maldonado alone received more than $400,000 in kickbacks for ordering more than $4 million worth of lab tests, and Dr. Canova received more than $300,000 for ordering more than $12 million in tests, according to the indictment.

The 26-count indictment included charges of conspiracy to commit healthcare fraud, conspiracy to pay and receive healthcare kickbacks, offering or paying illegal kickbacks, and soliciting or receiving illegal kickbacks.
 

N.J. doc charged on 34 counts of illegally prescribing controlled substances

A N.J. orthopedic surgeon has been charged with 34 counts of illegally prescribing controlled substances.

According to documents filed in the case, from November 2016 to February 2018 Evangelos Megariotis, MD, 68, of Passaic County, N.J., prescribed opiates — including oxycodone, alprazolam (Xanax), and cough syrup with codeine — as well as stimulants without a legitimate medical purpose and outside the usual course of his practice.

Before the State of New Jersey permanently banned him from practicing medicine, Dr. Megariotis owned and operated Clifton Orthopedic Associates, in Clifton, N.J.

According to The Bergin Record, the state alleges that Dr. Megariotis prescribed thousands of doses of painkillers even though he knew his patients were abusing them and in some cases were getting similar drugs from other doctors. In addition, Dr. Megariotis failed to diagnose or treat these patients’ underlying conditions, treated illnesses outside his scope of practice, and performed surgery in the absence of medical need.

If convicted, Dr. Megariotis could face a lengthy prison sentence as well as substantial fines. The counts of illegally prescribing Schedule II opioids and stimulants are punishable by a maximum of 20 years in prison and a $1 million fine. Illegally prescribing Schedule IV controlled substances brings a maximum of 5 years in prison and a $250,000 fine. The counts of illegally prescribing cough syrup with codeine, a Schedule V controlled substance, are punishable by a maximum of 1 year in prison and a $100,000 fine.
 

Michigan surgeon pleads guilty to fraud scheme

A Bay City, Mich., vascular surgeon has pleaded guilty to engaging in a scheme to defraud Medicare, Medicaid, and Blue Cross/Blue Shield of Michigan out of approximately $19.5 million

According to the plea agreement, in 2009, Vasso Godiali, MD, 59, began false and fraudulent billing to the three insurers. False claims included billing for the placement of stents in dialysis patients and for the treatment of arterial blood clots. The surgeon admitted to billing for the placement of multiple stents in the same vessel and preparing medical records to support the necessity of placing those stents. However, he never placed the stents.

In the plea document, Dr. Godiali also admitted that his medical records would describe occluded arteries that would justify arterial thrombectomies. However, in many cases, there were no occluded arteries, and no thrombectomies were performed, even though Dr. Godiali billed insurers for them.

“When Dr Godiali submitted claims for medical services that were never provided, he violated the trust of his patients and defrauded taxpayer-funded health care programs,” Mario M. Pinto, special agent in charge, said in a statement announcing the plea.

In 2014, The Bay City Times interviewed Dr. Godiali after he was featured by USA Today as one of seven physicians in the United States to receive more than $10 million for Medicare reimbursements in 2012. He told The Times he was a workaholic. “I work a lot — I work probably more than surgeons that you meet,” he told the paper.

Dr. Godiali faces up to 10 years in prison. In addition, he will be required to pay $19.5 million in restitution to the three insurers. A civil forfeiture case against approximately $39.9 million seized from accounts controlled by Dr. Godiali is pending. Sentencing is scheduled for September 15.

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

A Florida jury has found a Palm Beach psychiatrist guilty of one count of conspiracy to commit healthcare fraud and wire fraud and 11 counts of healthcare fraud.

Mark Agresti, MD, 59, was convicted of unlawfully billing approximately $110 million of medically unnecessary urinalysis services for patients living at Good Decisions Sober Living (GDSL), a drug rehabilitation facility in West Palm Beach, Fla. Dr. Agresti was once the director of psychiatry at the former Columbia Hospital in West Palm Beach.

According to evidence presented at the trial, Dr. Agresti, as medical director of GDSL, agreed to provide standing orders for urinalysis for GDSL patients in exchange for a monthly fee. Three to four times a week, patients were required to submit to excessive and medically unnecessary urine tests, costing $6,000 to $9,000 per test, according to federal officials. Dr. Agresti did not review the results of these tests and did not use the tests to treat patients. The evidence also showed that he had also done this at other addiction facilities in the West Palm Beach area, resulting in thousands of additional fraudulent tests. Dr. Agresti had GDSL patients visit his private practice so he could fraudulently bill for services there as well.

“This defendant used his medical license to facilitate an egregious, multimillion-dollar fraud scheme that exploited vulnerable substance abusers,” said Juan Antonio Gonzalez, U.S. Attorney for the Southern District of Florida, in a statement announcing the conviction.

Three other defendants, including GDSL’s owner, Kenneth Bailynson, were previously indicted and pleaded guilty to related charges connected with the scheme. Dr. Agresti, however, insisted on his innocence throughout the trial, arguing that he was himself the victim of Mr. Bailynson. Mr. Bailynson, as a part of his plea deal, testified against Dr. Agresti at the trial.

According to a report in the Palm Beach Post, Dr. Agresti’s lawyers, in closing statements, argued, “The government did a fantastic job of proving that Dr. Agresti was negligent, maybe even grossly negligent, but that’s not the issue in this case.” The jury disagreed.

Dr. Agresti faces a maximum penalty of 20 years in prison for the healthcare fraud and wire fraud conspiracy charges and 10 years for each count of healthcare fraud. Sentencing is scheduled for April 21.
 

Ten people, including two physicians, charged in Texas kickback scheme

Jose Maldonado, MD, 48, a family medicine physician, and Eduardo Carlos Canova, MD, 44, an internal medicine specialist, both based in Laredo, Tex., were among ten people indicted in connection with a $300 million healthcare fraud scheme

According to the federal indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs, LLC, allegedly paid kickbacks to medical practitioners in exchange for orders for medically unnecessary lab tests, which were then billed to Medicare and other federal healthcare programs. The medical professionals, including Dr. Maldonado and Dr. Canova, are alleged to have accepted bribes for ordering millions of dollars’ worth of tests.

The scheme was facilitated by marketing firms, which paid doctors hundreds of thousands of dollars for “advisory services,” according to officials. Rather than providing advice, however, the physicians provided lab test referrals. The labs are accused of paying portions of the salaries of the doctors’ staffs as well as portions of their leases. In some instances, direct payments were made to the practitioner’s spouse. In one case, the labs informed one practitioner that the payments would cease if he didn’t refer more tests. He responded to the threat by immediately increasing his lab referrals, averaging 20 to 30 referrals a day.

Jeffrey Madison, the founder of Spectrum and Unified, is accused of convincing Reliable’s founders to convert their business to a physician-owned lab to disguise the kickbacks. Reliable offered physicians ownership opportunities only if they referred enough lab tests. In some cases, says the indictment, the labs made advance payments to physicians to ensure that those physicians would not send samples to other labs.

The scheme resulted in more than $300 million in billing to federal government healthcare programs. Between 2015 and 2018, Dr. Maldonado alone received more than $400,000 in kickbacks for ordering more than $4 million worth of lab tests, and Dr. Canova received more than $300,000 for ordering more than $12 million in tests, according to the indictment.

The 26-count indictment included charges of conspiracy to commit healthcare fraud, conspiracy to pay and receive healthcare kickbacks, offering or paying illegal kickbacks, and soliciting or receiving illegal kickbacks.
 

N.J. doc charged on 34 counts of illegally prescribing controlled substances

A N.J. orthopedic surgeon has been charged with 34 counts of illegally prescribing controlled substances.

According to documents filed in the case, from November 2016 to February 2018 Evangelos Megariotis, MD, 68, of Passaic County, N.J., prescribed opiates — including oxycodone, alprazolam (Xanax), and cough syrup with codeine — as well as stimulants without a legitimate medical purpose and outside the usual course of his practice.

Before the State of New Jersey permanently banned him from practicing medicine, Dr. Megariotis owned and operated Clifton Orthopedic Associates, in Clifton, N.J.

According to The Bergin Record, the state alleges that Dr. Megariotis prescribed thousands of doses of painkillers even though he knew his patients were abusing them and in some cases were getting similar drugs from other doctors. In addition, Dr. Megariotis failed to diagnose or treat these patients’ underlying conditions, treated illnesses outside his scope of practice, and performed surgery in the absence of medical need.

If convicted, Dr. Megariotis could face a lengthy prison sentence as well as substantial fines. The counts of illegally prescribing Schedule II opioids and stimulants are punishable by a maximum of 20 years in prison and a $1 million fine. Illegally prescribing Schedule IV controlled substances brings a maximum of 5 years in prison and a $250,000 fine. The counts of illegally prescribing cough syrup with codeine, a Schedule V controlled substance, are punishable by a maximum of 1 year in prison and a $100,000 fine.
 

Michigan surgeon pleads guilty to fraud scheme

A Bay City, Mich., vascular surgeon has pleaded guilty to engaging in a scheme to defraud Medicare, Medicaid, and Blue Cross/Blue Shield of Michigan out of approximately $19.5 million

According to the plea agreement, in 2009, Vasso Godiali, MD, 59, began false and fraudulent billing to the three insurers. False claims included billing for the placement of stents in dialysis patients and for the treatment of arterial blood clots. The surgeon admitted to billing for the placement of multiple stents in the same vessel and preparing medical records to support the necessity of placing those stents. However, he never placed the stents.

In the plea document, Dr. Godiali also admitted that his medical records would describe occluded arteries that would justify arterial thrombectomies. However, in many cases, there were no occluded arteries, and no thrombectomies were performed, even though Dr. Godiali billed insurers for them.

“When Dr Godiali submitted claims for medical services that were never provided, he violated the trust of his patients and defrauded taxpayer-funded health care programs,” Mario M. Pinto, special agent in charge, said in a statement announcing the plea.

In 2014, The Bay City Times interviewed Dr. Godiali after he was featured by USA Today as one of seven physicians in the United States to receive more than $10 million for Medicare reimbursements in 2012. He told The Times he was a workaholic. “I work a lot — I work probably more than surgeons that you meet,” he told the paper.

Dr. Godiali faces up to 10 years in prison. In addition, he will be required to pay $19.5 million in restitution to the three insurers. A civil forfeiture case against approximately $39.9 million seized from accounts controlled by Dr. Godiali is pending. Sentencing is scheduled for September 15.

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