Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.

“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.

In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).

Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.

Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).

For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity

The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.

The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.

The researchers had no financial conflicts to disclose.

Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.

“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.

In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).

Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.

Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).

For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity

The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.

The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.

The researchers had no financial conflicts to disclose.

Biosimilars are primarily as safe as their originators, based on data from a review of current European regulatory documents. The findings were published online in the British Journal of Clinical Pharmacology.

“Biosimilars are officially approved as similar products to a biopharmaceutical originator, which often share the same International Nonproprietary Name,” wrote L.R.A. Lepelaars, MD, of Utrecht University, the Netherlands, and colleagues. However, many clinicians remain cautious about using biosimilars, particularly those in the United States, they noted. The European Medicines Agency (EMA) has filed safety data on biosimilars, but comparative effectiveness studies often are lacking, they wrote.

In this study, the researchers compared data on 25 biologic medicinal products (19 biosimilars and 6 originators). The biosimilars were authorized by the EMA between Jan. 1, 2005 and Oct. 30, 2015 (Br. J. Clin. Pharmacol. 2017 Nov 22; doi: 10.1111/bcp.13454).

Overall, the researchers found 55 general safety concerns, including 22 that were deemed highly clinically relevant. Another 21 were defined as medium, while 12 had low levels of clinical relevance.

Infliximab was the only active substance with more than one difference in safety concerns between the biosimilar and originator; three more general safety concerns (all of medium clinical relevance) were noted for infliximab biosimilars compared with the originator (bowel obstruction, hematologic reactions, and lack of efficacy).

For all other active substances included in the study, one difference or no difference was found in the general safety concerns between the biosimilars and originators, and none of the differences was related to immunogenicity

The researchers assessed the safety of biosimilars by comparing them with European Risk Management Plan or Summary of Product Characteristics.

The findings support the value of biosimilars based on comparable safety profiles, the researchers noted. However, “a direct comparison between biosimilars and related originators through formal postmarketing studies (observational or clinical trials) is mandatory for specific safety and effectiveness issues emerging during the products’ life cycle,” they said.

The researchers had no financial conflicts to disclose.

A lot has happened in oncology since the American Society of Clinical Oncology (ASCO) first issued its guidelines on platelet transfusion for patients with cancer in 2001, noted the authors of the updated recommendations.

“The expense of platelet transfusions, coupled with potential adverse effects such as febrile and allergic reactions, transfusion-related acute lung injury, and bacterial contamination point to the importance of evidence-based transfusion practice,” wrote Charles A Schiffer, MD, of Wayne State Michigan, Detroit, and his colleagues in the updated guidelines.

Many of the original recommendations remain unchanged, but there are updated evidence-based recommendations in five key areas.

For example, regarding platelet transfusion thresholds in the setting of hematologic stem-cell transplantation in adults, the guidelines incorporate evidence from randomized clinical trials showing that among adults who have received autologous hematologic stem-cell transplantation, bleeding rates with decreased use of platelets are similar whether patients are treated prophylactically or at the first sign of bleeding, “and this approach may be used in experienced centers,” wrote Dr. Schiffer and his colleagues (J Clin Oncol. 2017 Nov 28. doi: 10.1200/JCO.2017.76.1734).

The authors caution, however, that the recommendation applies to adults only.

Other updated recommendations include:

• Rhesus D alloimmunization from platelet transfusions to RhD-negative patients can be prevented through either exclusive use of platelet products from RhD-negative donors or immunoprophylaxis. The guidelines note that there is a low rate of RhD alloimmunization in cancer patients in general, but state that prevention may be used in girls and in women of child-bearing age who are being treated with curative intent.

• For patients with acute myeloid leukemia, receiving induction chemotherapy, the use of leukoreduced platelet and red blood cell products can reduce the likelihood that patients will develop alloantibody-mediated refractory reactions to plate transfusions.

“It is therefore appropriate to provide leukoreduced blood products to patients with [acute myeloid leukemia] from the time of diagnosis to ameliorate this important clinical problem,” the investigators wrote.

They noted that leukoreduction to prevent alloimmunization might benefit patients with other leukemia histologies and with other types of cancer who are undergoing chemotherapy, but added that there is a lack of evidence to support this as a recommendation outside of acute myeloid leukemia.

To reduce the risk of bleeding due to thrombocytopenia in patients with solid tumors who are undergoing chemotherapy, the panelists recommend transfusing patients when their platelet levels fall below 10 x 109 per liter. It is appropriate to give platelet transfusions to patients with higher levels when there is active localized bleeding, they stated.

The guideline authors also recommend that when refractoriness to platelet infusions is suspected, clinicians should perform platelet counts from 10 to 60 minutes after the transfusion is completed. A refractoriness determination should be made only after two or more infusions of ABO-compatible units that have been stored for less than 72 hours result in poor increments, they advised.

The guideline development process is supported by ASCO. Dr. Schiffer and six other guideline authors disclosed consulting or advisory roles, research funding, honoraria and/or fees with various pharmaceutical companies or other corporate entities.
 

A lot has happened in oncology since the American Society of Clinical Oncology (ASCO) first issued its guidelines on platelet transfusion for patients with cancer in 2001, noted the authors of the updated recommendations.

“The expense of platelet transfusions, coupled with potential adverse effects such as febrile and allergic reactions, transfusion-related acute lung injury, and bacterial contamination point to the importance of evidence-based transfusion practice,” wrote Charles A Schiffer, MD, of Wayne State Michigan, Detroit, and his colleagues in the updated guidelines.

Many of the original recommendations remain unchanged, but there are updated evidence-based recommendations in five key areas.

For example, regarding platelet transfusion thresholds in the setting of hematologic stem-cell transplantation in adults, the guidelines incorporate evidence from randomized clinical trials showing that among adults who have received autologous hematologic stem-cell transplantation, bleeding rates with decreased use of platelets are similar whether patients are treated prophylactically or at the first sign of bleeding, “and this approach may be used in experienced centers,” wrote Dr. Schiffer and his colleagues (J Clin Oncol. 2017 Nov 28. doi: 10.1200/JCO.2017.76.1734).

The authors caution, however, that the recommendation applies to adults only.

Other updated recommendations include:

• Rhesus D alloimmunization from platelet transfusions to RhD-negative patients can be prevented through either exclusive use of platelet products from RhD-negative donors or immunoprophylaxis. The guidelines note that there is a low rate of RhD alloimmunization in cancer patients in general, but state that prevention may be used in girls and in women of child-bearing age who are being treated with curative intent.

• For patients with acute myeloid leukemia, receiving induction chemotherapy, the use of leukoreduced platelet and red blood cell products can reduce the likelihood that patients will develop alloantibody-mediated refractory reactions to plate transfusions.

“It is therefore appropriate to provide leukoreduced blood products to patients with [acute myeloid leukemia] from the time of diagnosis to ameliorate this important clinical problem,” the investigators wrote.

They noted that leukoreduction to prevent alloimmunization might benefit patients with other leukemia histologies and with other types of cancer who are undergoing chemotherapy, but added that there is a lack of evidence to support this as a recommendation outside of acute myeloid leukemia.

To reduce the risk of bleeding due to thrombocytopenia in patients with solid tumors who are undergoing chemotherapy, the panelists recommend transfusing patients when their platelet levels fall below 10 x 109 per liter. It is appropriate to give platelet transfusions to patients with higher levels when there is active localized bleeding, they stated.

The guideline authors also recommend that when refractoriness to platelet infusions is suspected, clinicians should perform platelet counts from 10 to 60 minutes after the transfusion is completed. A refractoriness determination should be made only after two or more infusions of ABO-compatible units that have been stored for less than 72 hours result in poor increments, they advised.

The guideline development process is supported by ASCO. Dr. Schiffer and six other guideline authors disclosed consulting or advisory roles, research funding, honoraria and/or fees with various pharmaceutical companies or other corporate entities.
 

A lot has happened in oncology since the American Society of Clinical Oncology (ASCO) first issued its guidelines on platelet transfusion for patients with cancer in 2001, noted the authors of the updated recommendations.

“The expense of platelet transfusions, coupled with potential adverse effects such as febrile and allergic reactions, transfusion-related acute lung injury, and bacterial contamination point to the importance of evidence-based transfusion practice,” wrote Charles A Schiffer, MD, of Wayne State Michigan, Detroit, and his colleagues in the updated guidelines.

Many of the original recommendations remain unchanged, but there are updated evidence-based recommendations in five key areas.

For example, regarding platelet transfusion thresholds in the setting of hematologic stem-cell transplantation in adults, the guidelines incorporate evidence from randomized clinical trials showing that among adults who have received autologous hematologic stem-cell transplantation, bleeding rates with decreased use of platelets are similar whether patients are treated prophylactically or at the first sign of bleeding, “and this approach may be used in experienced centers,” wrote Dr. Schiffer and his colleagues (J Clin Oncol. 2017 Nov 28. doi: 10.1200/JCO.2017.76.1734).

The authors caution, however, that the recommendation applies to adults only.

Other updated recommendations include:

• Rhesus D alloimmunization from platelet transfusions to RhD-negative patients can be prevented through either exclusive use of platelet products from RhD-negative donors or immunoprophylaxis. The guidelines note that there is a low rate of RhD alloimmunization in cancer patients in general, but state that prevention may be used in girls and in women of child-bearing age who are being treated with curative intent.

• For patients with acute myeloid leukemia, receiving induction chemotherapy, the use of leukoreduced platelet and red blood cell products can reduce the likelihood that patients will develop alloantibody-mediated refractory reactions to plate transfusions.

“It is therefore appropriate to provide leukoreduced blood products to patients with [acute myeloid leukemia] from the time of diagnosis to ameliorate this important clinical problem,” the investigators wrote.

They noted that leukoreduction to prevent alloimmunization might benefit patients with other leukemia histologies and with other types of cancer who are undergoing chemotherapy, but added that there is a lack of evidence to support this as a recommendation outside of acute myeloid leukemia.

To reduce the risk of bleeding due to thrombocytopenia in patients with solid tumors who are undergoing chemotherapy, the panelists recommend transfusing patients when their platelet levels fall below 10 x 109 per liter. It is appropriate to give platelet transfusions to patients with higher levels when there is active localized bleeding, they stated.

The guideline authors also recommend that when refractoriness to platelet infusions is suspected, clinicians should perform platelet counts from 10 to 60 minutes after the transfusion is completed. A refractoriness determination should be made only after two or more infusions of ABO-compatible units that have been stored for less than 72 hours result in poor increments, they advised.

The guideline development process is supported by ASCO. Dr. Schiffer and six other guideline authors disclosed consulting or advisory roles, research funding, honoraria and/or fees with various pharmaceutical companies or other corporate entities.
 

A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.

Which of these treatments do you recommend?

A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).

B. Oxygen, morphine, ASA.

C. ASA.

In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.

There is controversy over the safety of routine morphine use for patients with chest pain.

Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.¹ Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.² Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.³

Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).⁴ They found no increase in in-hospital complications or 1-year mortality.

The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.^5,6

It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.⁷

The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.

In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).⁸ They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.

Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.⁹

Dr. Tubbesing is a senior resident in medicine at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Am Heart J. 2005 Jun;149(6):1043-9.

2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.

3. Clin Res Cardiol. 2015 Sep;104(9):727-34.

4. Eur Heart J. 2016 Apr 1;37(13):1063-71.

5. BMJ. 1900 Dec 1;2(2083):1568.

6. JAMA. 1930 May 3;94(18):1363-5.

7. Br Med J. 1976 May 8;1(6018):1121-3.

8. Circulation. 2015 Jun 16;131(24):2143-50.

9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.

10. N Engl J Med. 2017 Sep 28;377(13):1240-9.

A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.

Which of these treatments do you recommend?

A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).

B. Oxygen, morphine, ASA.

C. ASA.

In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.

There is controversy over the safety of routine morphine use for patients with chest pain.

Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.¹ Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.² Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.³

Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).⁴ They found no increase in in-hospital complications or 1-year mortality.

The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.^5,6

It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.⁷

The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.

In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).⁸ They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.

Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.⁹

Dr. Tubbesing is a senior resident in medicine at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Am Heart J. 2005 Jun;149(6):1043-9.

2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.

3. Clin Res Cardiol. 2015 Sep;104(9):727-34.

4. Eur Heart J. 2016 Apr 1;37(13):1063-71.

5. BMJ. 1900 Dec 1;2(2083):1568.

6. JAMA. 1930 May 3;94(18):1363-5.

7. Br Med J. 1976 May 8;1(6018):1121-3.

8. Circulation. 2015 Jun 16;131(24):2143-50.

9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.

10. N Engl J Med. 2017 Sep 28;377(13):1240-9.

A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.

Which of these treatments do you recommend?

A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).

B. Oxygen, morphine, ASA.

C. ASA.

In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.

There is controversy over the safety of routine morphine use for patients with chest pain.

Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.¹ Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.² Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.³

Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).⁴ They found no increase in in-hospital complications or 1-year mortality.

The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.^5,6

It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.⁷

The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.

In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).⁸ They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.

Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.⁹

Dr. Tubbesing is a senior resident in medicine at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Am Heart J. 2005 Jun;149(6):1043-9.

2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.

3. Clin Res Cardiol. 2015 Sep;104(9):727-34.

4. Eur Heart J. 2016 Apr 1;37(13):1063-71.

5. BMJ. 1900 Dec 1;2(2083):1568.

6. JAMA. 1930 May 3;94(18):1363-5.

7. Br Med J. 1976 May 8;1(6018):1121-3.

8. Circulation. 2015 Jun 16;131(24):2143-50.

9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.

10. N Engl J Med. 2017 Sep 28;377(13):1240-9.

The Diagnosis: Epstein-Barr Virus

Physical examination revealed bilateral 1-cm ulcerated lesions on the labia minora with vulvar edema (Figure). She had a palpable liver edge but no splenomegaly, oral ulcers or lesions, conjunctivitis or scleral icterus, or cervical or inguinal lymphadenopathy. A detailed genitourinary examination was performed under anesthesia, but the hymen was not commented on. Inflammatory markers were elevated with a C-reactive protein level of 16.4 mg/L (reference range, 0.08-3.1 mg/mL), erythrocyte sedimentation rate of39 mm/h (reference range, 0-20 mm/h), white blood cell count of 7.1×10⁹/L (reference range, 4.5-11.0×10⁹/L) with 57% neutrophils and 30% lymphocytes, an alanine aminotransferase level of 41 U/L (reference range, 10-40 U/L), and an aspartate aminotransferase level of 126 U/L (reference range, 10-30 U/L). 

Bacterial and fungal cultures of vulvar tissue were negative as well as blood and urine cultures. Serological tests for herpes simplex virus (HSV), syphilis, and cytomegalovirus were negative, and urine testing for gonorrhea and chlamydia were negative. Serologies for Epstein-Barr virus (EBV) all were strongly positive with an EBV viral capsid antigen (VCA) IgM greater than 160 U/mL, early antigen IgG of 68 U/mL, and EBV VCA IgG of 456 U/mL. Two years after the initial presentation, repeat EBV serologies were obtained, showing a strongly positive EBV VCA IgG (>8.0 antibody index; reference range, 0-0.8), and a negative EBV VCA IgM.

Infectious etiologies of genital ulcers in a sexually active female include HSV, syphilis, lymphogranuloma venereum, and chancroid. Herpes simplex virus often is the assumed etiology of genital ulcers, especially in sexually active patients, and misdiagnosis in the setting of negative HSV testing may be high. Less common infectious causes such as mumps and cytomegalovirus also have been reported.^1,2 Lichen planus and lichen sclerosus are noninfectious inflammatory causes, both of which may involve and be limited to the genitals. Autoimmune disorders include Crohn disease and Behçet disease, and vulvar ulcers with an eschar, consistent with aphthous major or complex apotheosis, has been used to describe patients with severe recurrent oral and genital ulcerations without other systemic manifestations of Behçet disease.³

Genital ulcers are an uncommon manifestation of EBV infection. The formation of genital ulcers in EBV infection has been hypothesized to be due to immune complex formation during the acute phase that becomes activated in the vasculature, leading to microthrombosis and eventually necrosis of the tissue.⁴ The mode of transmission for EBV-related acute genital ulcers has been postulated to be hematogenous spread in lymphocytes or EBV shedding in the urine with subsequent transfer to the genital mucosa.⁵

Epstein-Barr virus-related acute genital ulcers are self-limiting. The average healing time for the ulcers is 14 to 18 days.^6,7 Antivirals are ineffective in treating this condition; however, supportive treatment with systemic glucocorticoids for associated swelling and pain medications could be considered. Our patient was treated symptomatically. Two weeks after debridement, granulation tissue was noted at the site and her pain and discomfort had resolved. This case illustrates an uncommon manifestation of EBV in a sexually inactive adolescent and is a reminder for the dermatologist of the diverse spectrum of illness caused by this common virus.

The Diagnosis: Epstein-Barr Virus

Physical examination revealed bilateral 1-cm ulcerated lesions on the labia minora with vulvar edema (Figure). She had a palpable liver edge but no splenomegaly, oral ulcers or lesions, conjunctivitis or scleral icterus, or cervical or inguinal lymphadenopathy. A detailed genitourinary examination was performed under anesthesia, but the hymen was not commented on. Inflammatory markers were elevated with a C-reactive protein level of 16.4 mg/L (reference range, 0.08-3.1 mg/mL), erythrocyte sedimentation rate of39 mm/h (reference range, 0-20 mm/h), white blood cell count of 7.1×10⁹/L (reference range, 4.5-11.0×10⁹/L) with 57% neutrophils and 30% lymphocytes, an alanine aminotransferase level of 41 U/L (reference range, 10-40 U/L), and an aspartate aminotransferase level of 126 U/L (reference range, 10-30 U/L). 

Bacterial and fungal cultures of vulvar tissue were negative as well as blood and urine cultures. Serological tests for herpes simplex virus (HSV), syphilis, and cytomegalovirus were negative, and urine testing for gonorrhea and chlamydia were negative. Serologies for Epstein-Barr virus (EBV) all were strongly positive with an EBV viral capsid antigen (VCA) IgM greater than 160 U/mL, early antigen IgG of 68 U/mL, and EBV VCA IgG of 456 U/mL. Two years after the initial presentation, repeat EBV serologies were obtained, showing a strongly positive EBV VCA IgG (>8.0 antibody index; reference range, 0-0.8), and a negative EBV VCA IgM.

Infectious etiologies of genital ulcers in a sexually active female include HSV, syphilis, lymphogranuloma venereum, and chancroid. Herpes simplex virus often is the assumed etiology of genital ulcers, especially in sexually active patients, and misdiagnosis in the setting of negative HSV testing may be high. Less common infectious causes such as mumps and cytomegalovirus also have been reported.^1,2 Lichen planus and lichen sclerosus are noninfectious inflammatory causes, both of which may involve and be limited to the genitals. Autoimmune disorders include Crohn disease and Behçet disease, and vulvar ulcers with an eschar, consistent with aphthous major or complex apotheosis, has been used to describe patients with severe recurrent oral and genital ulcerations without other systemic manifestations of Behçet disease.³

Genital ulcers are an uncommon manifestation of EBV infection. The formation of genital ulcers in EBV infection has been hypothesized to be due to immune complex formation during the acute phase that becomes activated in the vasculature, leading to microthrombosis and eventually necrosis of the tissue.⁴ The mode of transmission for EBV-related acute genital ulcers has been postulated to be hematogenous spread in lymphocytes or EBV shedding in the urine with subsequent transfer to the genital mucosa.⁵

Epstein-Barr virus-related acute genital ulcers are self-limiting. The average healing time for the ulcers is 14 to 18 days.^6,7 Antivirals are ineffective in treating this condition; however, supportive treatment with systemic glucocorticoids for associated swelling and pain medications could be considered. Our patient was treated symptomatically. Two weeks after debridement, granulation tissue was noted at the site and her pain and discomfort had resolved. This case illustrates an uncommon manifestation of EBV in a sexually inactive adolescent and is a reminder for the dermatologist of the diverse spectrum of illness caused by this common virus.

The Diagnosis: Epstein-Barr Virus

Physical examination revealed bilateral 1-cm ulcerated lesions on the labia minora with vulvar edema (Figure). She had a palpable liver edge but no splenomegaly, oral ulcers or lesions, conjunctivitis or scleral icterus, or cervical or inguinal lymphadenopathy. A detailed genitourinary examination was performed under anesthesia, but the hymen was not commented on. Inflammatory markers were elevated with a C-reactive protein level of 16.4 mg/L (reference range, 0.08-3.1 mg/mL), erythrocyte sedimentation rate of39 mm/h (reference range, 0-20 mm/h), white blood cell count of 7.1×10⁹/L (reference range, 4.5-11.0×10⁹/L) with 57% neutrophils and 30% lymphocytes, an alanine aminotransferase level of 41 U/L (reference range, 10-40 U/L), and an aspartate aminotransferase level of 126 U/L (reference range, 10-30 U/L). 

Bacterial and fungal cultures of vulvar tissue were negative as well as blood and urine cultures. Serological tests for herpes simplex virus (HSV), syphilis, and cytomegalovirus were negative, and urine testing for gonorrhea and chlamydia were negative. Serologies for Epstein-Barr virus (EBV) all were strongly positive with an EBV viral capsid antigen (VCA) IgM greater than 160 U/mL, early antigen IgG of 68 U/mL, and EBV VCA IgG of 456 U/mL. Two years after the initial presentation, repeat EBV serologies were obtained, showing a strongly positive EBV VCA IgG (>8.0 antibody index; reference range, 0-0.8), and a negative EBV VCA IgM.

Infectious etiologies of genital ulcers in a sexually active female include HSV, syphilis, lymphogranuloma venereum, and chancroid. Herpes simplex virus often is the assumed etiology of genital ulcers, especially in sexually active patients, and misdiagnosis in the setting of negative HSV testing may be high. Less common infectious causes such as mumps and cytomegalovirus also have been reported.^1,2 Lichen planus and lichen sclerosus are noninfectious inflammatory causes, both of which may involve and be limited to the genitals. Autoimmune disorders include Crohn disease and Behçet disease, and vulvar ulcers with an eschar, consistent with aphthous major or complex apotheosis, has been used to describe patients with severe recurrent oral and genital ulcerations without other systemic manifestations of Behçet disease.³

Genital ulcers are an uncommon manifestation of EBV infection. The formation of genital ulcers in EBV infection has been hypothesized to be due to immune complex formation during the acute phase that becomes activated in the vasculature, leading to microthrombosis and eventually necrosis of the tissue.⁴ The mode of transmission for EBV-related acute genital ulcers has been postulated to be hematogenous spread in lymphocytes or EBV shedding in the urine with subsequent transfer to the genital mucosa.⁵

Epstein-Barr virus-related acute genital ulcers are self-limiting. The average healing time for the ulcers is 14 to 18 days.^6,7 Antivirals are ineffective in treating this condition; however, supportive treatment with systemic glucocorticoids for associated swelling and pain medications could be considered. Our patient was treated symptomatically. Two weeks after debridement, granulation tissue was noted at the site and her pain and discomfort had resolved. This case illustrates an uncommon manifestation of EBV in a sexually inactive adolescent and is a reminder for the dermatologist of the diverse spectrum of illness caused by this common virus.

Years ago, after the revelation of sexual predations of male members of the U.S. Navy upon their female underlings, the Navy announced a “zero tolerance” policy. I, then the chair of the American Psychiatric Association Committee on Women, was invited to address a meeting of top Naval officers. They seemed dismayed when I told them that zero tolerance was just the beginning. Declarations that certain behaviors are unacceptable are facile, flimsy, and ultimately disingenuous substitutes for the infinitely more difficult task of monitoring and policing forbidden behaviors and protecting potential and actual victims.

The United States, I pointed out, has a zero tolerance policy on murder but still has to maintain a large force of police officers, detectives, judges, and prison guards to enforce that policy. The Navy had to have a similar approach to sexual assaults. Judging from the recent reports of female members of the military, that hasn’t happened.

Clarity in the law

Unwanted physical intrusion by one adult on another is against the law in the United States. Then why do we need laws specifically banning rape? In addition to the fact that rape, unlike any other assault, can result in conception, sexual assault is recognized as a particularly and uniquely evil and damaging invasion and degradation.

Although there are cultural differences about responsibility for rape, and whether marriage obviates a woman’s right to refuse sexual contact, there is little or no dispute about the need to recognize rape as a distinct, degrading, and particularly heinous attack. It is, therefore, no surprise that people who are raped feel soiled, shamed, and degraded. Those feelings are exacerbated by centuries of shifting responsibility for sexual assault, whether forced intercourse or other unwanted sexual behavior, from the perpetrator onto the victim.

The shifting of blame has been rejected in theory, but it very much persists in actuality. Who among us does not wonder how the victim was dressed or why (s)he was on that street, at that party, in that man’s room? Other forms of harassment echo the motivations of rape – to demonstrate the unanswerable power to degrade – and result in similar psychological responses.

The recent media revelations have lumped physical assault together with unwanted touching, sexual acts undergone as a result of psychological coercion, unwanted exposure to perpetrators’ genitalia and masturbation, and offensive sexual requests and comments. All of those acts are wrong, but they are not equivalent. An elderly man in a wheelchair grabbing an adult woman’s buttocks is not in the same category as an adult man sexually assaulting an underage girl.

What is the genesis of all this misbehavior? It’s not just about sex; it’s about sex and power. For many men, bragging about sexual conquests and making derogatory remarks about women’s physical appearance demonstrate machismo – define maleness.

It is not surprising that such comments are called “locker room talk”; sports are macho displays as well. Physically violating sexual boundaries is just the talk put into action. And macho works. Last November, more than 40% of female voters in the United States voted for the candidate who reportedly cheated on at least one of his three wives, bragged about unwanted sexual assault, and has been credibly accused of many other illegal and/or inappropriate behaviors.

Where does it end?

What is going to be the result of all this hullabaloo? The list of convincingly accused perpetrators grows by the day. Sexism and sexual misbehavior are endemic in every sphere of human endeavor, up to and including, of course, the clergy, who are meant to be models and protectors of virtue. The scope of recent revelations may be unusual, but revelations about one sector or another have happened every few years: the military, clergy, Wall Street, Silicon Valley, academia. What would happen if all the sexual misbehavior were to be revealed, and the perpetrators removed from their leadership and management positions? Would we have a film industry, a financial industry, a legislature? I saw a headline somewhere: “He’s always indispensable; you never are.” The argument, or myth, of indispensability is a powerful protection for powerful individuals. The powerful are too powerful to tolerate mass expulsions. Already, Congress has resorted to the time-honored and demonstrably useless response: training. Others among the accused report that they are undergoing treatment of sex addiction, a diagnosis our profession has wisely discarded, and for which there was no effective treatment.

Sex, while not addictive, does have a role in sexual misbehavior. Through the ages, women’s reproductive hormones have been a focus of social and medical attention, as the source of unpleasant behaviors, and, in fact, psychopathology: premenstrual dysphoric disorder, postpartum depression. Little or no attention has been paid to the problematic psychosocial effects of male reproductive hormones. In addition to the offensive behaviors currently in the headlines, there is the behavior of adolescent males. Isn’t reckless driving related to the pubertal influx of testosterone (Neurosci Biobehav Rev. 2006;30[3]:319-45)? This gender discrepancy deserves scientific and social attention.

What can psychiatrists do to help women (and men) who are affected by sexual misbehavior? This is a difficult problem. What would help most victims, of any injustice, most would be to confront those responsible, and see them removed from positions of power and otherwise punished. However, the recent reports of seemingly swift and severe responses are misleading. The responsible journalists who have reported these cases have, in most cases, devoted months to finding victimized women, persuading them to go public, and corroborating their accounts. The perpetrators, even when complaints have been made, have gone unpunished, and often been promoted, for years or even decades. Women who complain often are subject to employer retaliation.

So a treating psychiatrist is left with less-than-satisfactory recommendations and responses. The most important intervention is to identify and counter the patient’s inaccurate and damaging assumptions: that she was responsible, that she should and could have refused to tolerate the misbehavior, that she has been left tainted, impure. Some social groups and families will have reinforced the latter feeling. The remainder of the psychiatric intervention will be focused on the patient’s particular symptoms – of posttraumatic stress, anxiety, or depression – and the relationship between her symptoms, history, and psychodynamics. Group therapy or other support by women who have faced similar abuse may be helpful. I’m afraid that we will continue to have many such patients to treat.

Dr. Stotland, past president of the American Psychiatric Association, is professor of psychiatry, and obstetrics and gynecology, at Rush Medical College, Chicago. She has written numerous articles and books, including “Cutting Edge Medicine: What Psychiatrists Need to Know” (American Psychiatric Association Publishing, 2002).

Years ago, after the revelation of sexual predations of male members of the U.S. Navy upon their female underlings, the Navy announced a “zero tolerance” policy. I, then the chair of the American Psychiatric Association Committee on Women, was invited to address a meeting of top Naval officers. They seemed dismayed when I told them that zero tolerance was just the beginning. Declarations that certain behaviors are unacceptable are facile, flimsy, and ultimately disingenuous substitutes for the infinitely more difficult task of monitoring and policing forbidden behaviors and protecting potential and actual victims.

The United States, I pointed out, has a zero tolerance policy on murder but still has to maintain a large force of police officers, detectives, judges, and prison guards to enforce that policy. The Navy had to have a similar approach to sexual assaults. Judging from the recent reports of female members of the military, that hasn’t happened.

Clarity in the law

Unwanted physical intrusion by one adult on another is against the law in the United States. Then why do we need laws specifically banning rape? In addition to the fact that rape, unlike any other assault, can result in conception, sexual assault is recognized as a particularly and uniquely evil and damaging invasion and degradation.

Although there are cultural differences about responsibility for rape, and whether marriage obviates a woman’s right to refuse sexual contact, there is little or no dispute about the need to recognize rape as a distinct, degrading, and particularly heinous attack. It is, therefore, no surprise that people who are raped feel soiled, shamed, and degraded. Those feelings are exacerbated by centuries of shifting responsibility for sexual assault, whether forced intercourse or other unwanted sexual behavior, from the perpetrator onto the victim.

The shifting of blame has been rejected in theory, but it very much persists in actuality. Who among us does not wonder how the victim was dressed or why (s)he was on that street, at that party, in that man’s room? Other forms of harassment echo the motivations of rape – to demonstrate the unanswerable power to degrade – and result in similar psychological responses.

The recent media revelations have lumped physical assault together with unwanted touching, sexual acts undergone as a result of psychological coercion, unwanted exposure to perpetrators’ genitalia and masturbation, and offensive sexual requests and comments. All of those acts are wrong, but they are not equivalent. An elderly man in a wheelchair grabbing an adult woman’s buttocks is not in the same category as an adult man sexually assaulting an underage girl.

What is the genesis of all this misbehavior? It’s not just about sex; it’s about sex and power. For many men, bragging about sexual conquests and making derogatory remarks about women’s physical appearance demonstrate machismo – define maleness.

It is not surprising that such comments are called “locker room talk”; sports are macho displays as well. Physically violating sexual boundaries is just the talk put into action. And macho works. Last November, more than 40% of female voters in the United States voted for the candidate who reportedly cheated on at least one of his three wives, bragged about unwanted sexual assault, and has been credibly accused of many other illegal and/or inappropriate behaviors.

Where does it end?

What is going to be the result of all this hullabaloo? The list of convincingly accused perpetrators grows by the day. Sexism and sexual misbehavior are endemic in every sphere of human endeavor, up to and including, of course, the clergy, who are meant to be models and protectors of virtue. The scope of recent revelations may be unusual, but revelations about one sector or another have happened every few years: the military, clergy, Wall Street, Silicon Valley, academia. What would happen if all the sexual misbehavior were to be revealed, and the perpetrators removed from their leadership and management positions? Would we have a film industry, a financial industry, a legislature? I saw a headline somewhere: “He’s always indispensable; you never are.” The argument, or myth, of indispensability is a powerful protection for powerful individuals. The powerful are too powerful to tolerate mass expulsions. Already, Congress has resorted to the time-honored and demonstrably useless response: training. Others among the accused report that they are undergoing treatment of sex addiction, a diagnosis our profession has wisely discarded, and for which there was no effective treatment.

Sex, while not addictive, does have a role in sexual misbehavior. Through the ages, women’s reproductive hormones have been a focus of social and medical attention, as the source of unpleasant behaviors, and, in fact, psychopathology: premenstrual dysphoric disorder, postpartum depression. Little or no attention has been paid to the problematic psychosocial effects of male reproductive hormones. In addition to the offensive behaviors currently in the headlines, there is the behavior of adolescent males. Isn’t reckless driving related to the pubertal influx of testosterone (Neurosci Biobehav Rev. 2006;30[3]:319-45)? This gender discrepancy deserves scientific and social attention.

What can psychiatrists do to help women (and men) who are affected by sexual misbehavior? This is a difficult problem. What would help most victims, of any injustice, most would be to confront those responsible, and see them removed from positions of power and otherwise punished. However, the recent reports of seemingly swift and severe responses are misleading. The responsible journalists who have reported these cases have, in most cases, devoted months to finding victimized women, persuading them to go public, and corroborating their accounts. The perpetrators, even when complaints have been made, have gone unpunished, and often been promoted, for years or even decades. Women who complain often are subject to employer retaliation.

So a treating psychiatrist is left with less-than-satisfactory recommendations and responses. The most important intervention is to identify and counter the patient’s inaccurate and damaging assumptions: that she was responsible, that she should and could have refused to tolerate the misbehavior, that she has been left tainted, impure. Some social groups and families will have reinforced the latter feeling. The remainder of the psychiatric intervention will be focused on the patient’s particular symptoms – of posttraumatic stress, anxiety, or depression – and the relationship between her symptoms, history, and psychodynamics. Group therapy or other support by women who have faced similar abuse may be helpful. I’m afraid that we will continue to have many such patients to treat.

Dr. Stotland, past president of the American Psychiatric Association, is professor of psychiatry, and obstetrics and gynecology, at Rush Medical College, Chicago. She has written numerous articles and books, including “Cutting Edge Medicine: What Psychiatrists Need to Know” (American Psychiatric Association Publishing, 2002).

Years ago, after the revelation of sexual predations of male members of the U.S. Navy upon their female underlings, the Navy announced a “zero tolerance” policy. I, then the chair of the American Psychiatric Association Committee on Women, was invited to address a meeting of top Naval officers. They seemed dismayed when I told them that zero tolerance was just the beginning. Declarations that certain behaviors are unacceptable are facile, flimsy, and ultimately disingenuous substitutes for the infinitely more difficult task of monitoring and policing forbidden behaviors and protecting potential and actual victims.

The United States, I pointed out, has a zero tolerance policy on murder but still has to maintain a large force of police officers, detectives, judges, and prison guards to enforce that policy. The Navy had to have a similar approach to sexual assaults. Judging from the recent reports of female members of the military, that hasn’t happened.

Clarity in the law

Unwanted physical intrusion by one adult on another is against the law in the United States. Then why do we need laws specifically banning rape? In addition to the fact that rape, unlike any other assault, can result in conception, sexual assault is recognized as a particularly and uniquely evil and damaging invasion and degradation.

Although there are cultural differences about responsibility for rape, and whether marriage obviates a woman’s right to refuse sexual contact, there is little or no dispute about the need to recognize rape as a distinct, degrading, and particularly heinous attack. It is, therefore, no surprise that people who are raped feel soiled, shamed, and degraded. Those feelings are exacerbated by centuries of shifting responsibility for sexual assault, whether forced intercourse or other unwanted sexual behavior, from the perpetrator onto the victim.

The shifting of blame has been rejected in theory, but it very much persists in actuality. Who among us does not wonder how the victim was dressed or why (s)he was on that street, at that party, in that man’s room? Other forms of harassment echo the motivations of rape – to demonstrate the unanswerable power to degrade – and result in similar psychological responses.

The recent media revelations have lumped physical assault together with unwanted touching, sexual acts undergone as a result of psychological coercion, unwanted exposure to perpetrators’ genitalia and masturbation, and offensive sexual requests and comments. All of those acts are wrong, but they are not equivalent. An elderly man in a wheelchair grabbing an adult woman’s buttocks is not in the same category as an adult man sexually assaulting an underage girl.

What is the genesis of all this misbehavior? It’s not just about sex; it’s about sex and power. For many men, bragging about sexual conquests and making derogatory remarks about women’s physical appearance demonstrate machismo – define maleness.

It is not surprising that such comments are called “locker room talk”; sports are macho displays as well. Physically violating sexual boundaries is just the talk put into action. And macho works. Last November, more than 40% of female voters in the United States voted for the candidate who reportedly cheated on at least one of his three wives, bragged about unwanted sexual assault, and has been credibly accused of many other illegal and/or inappropriate behaviors.

Where does it end?

What is going to be the result of all this hullabaloo? The list of convincingly accused perpetrators grows by the day. Sexism and sexual misbehavior are endemic in every sphere of human endeavor, up to and including, of course, the clergy, who are meant to be models and protectors of virtue. The scope of recent revelations may be unusual, but revelations about one sector or another have happened every few years: the military, clergy, Wall Street, Silicon Valley, academia. What would happen if all the sexual misbehavior were to be revealed, and the perpetrators removed from their leadership and management positions? Would we have a film industry, a financial industry, a legislature? I saw a headline somewhere: “He’s always indispensable; you never are.” The argument, or myth, of indispensability is a powerful protection for powerful individuals. The powerful are too powerful to tolerate mass expulsions. Already, Congress has resorted to the time-honored and demonstrably useless response: training. Others among the accused report that they are undergoing treatment of sex addiction, a diagnosis our profession has wisely discarded, and for which there was no effective treatment.

Sex, while not addictive, does have a role in sexual misbehavior. Through the ages, women’s reproductive hormones have been a focus of social and medical attention, as the source of unpleasant behaviors, and, in fact, psychopathology: premenstrual dysphoric disorder, postpartum depression. Little or no attention has been paid to the problematic psychosocial effects of male reproductive hormones. In addition to the offensive behaviors currently in the headlines, there is the behavior of adolescent males. Isn’t reckless driving related to the pubertal influx of testosterone (Neurosci Biobehav Rev. 2006;30[3]:319-45)? This gender discrepancy deserves scientific and social attention.

What can psychiatrists do to help women (and men) who are affected by sexual misbehavior? This is a difficult problem. What would help most victims, of any injustice, most would be to confront those responsible, and see them removed from positions of power and otherwise punished. However, the recent reports of seemingly swift and severe responses are misleading. The responsible journalists who have reported these cases have, in most cases, devoted months to finding victimized women, persuading them to go public, and corroborating their accounts. The perpetrators, even when complaints have been made, have gone unpunished, and often been promoted, for years or even decades. Women who complain often are subject to employer retaliation.

So a treating psychiatrist is left with less-than-satisfactory recommendations and responses. The most important intervention is to identify and counter the patient’s inaccurate and damaging assumptions: that she was responsible, that she should and could have refused to tolerate the misbehavior, that she has been left tainted, impure. Some social groups and families will have reinforced the latter feeling. The remainder of the psychiatric intervention will be focused on the patient’s particular symptoms – of posttraumatic stress, anxiety, or depression – and the relationship between her symptoms, history, and psychodynamics. Group therapy or other support by women who have faced similar abuse may be helpful. I’m afraid that we will continue to have many such patients to treat.

Dr. Stotland, past president of the American Psychiatric Association, is professor of psychiatry, and obstetrics and gynecology, at Rush Medical College, Chicago. She has written numerous articles and books, including “Cutting Edge Medicine: What Psychiatrists Need to Know” (American Psychiatric Association Publishing, 2002).

BOSTON – Changes in the retina seem to mirror changes that begin to reshape the brain in preclinical Alzheimer’s disease.

Manifested as a reduction in volume in the retinal nerve fiber layer, these changes appear to track the aggregation of beta amyloid brain plaques well before cognitive problems arise – and can be easily measured with a piece of equipment already in many optometry offices, Peter J. Snyder, PhD, said at the Clinical Trials in Alzheimer’s Disease conference.

Courtesy Dr. Peter Synder

[email protected]

On Twitter @Alz_Gal

BOSTON – Changes in the retina seem to mirror changes that begin to reshape the brain in preclinical Alzheimer’s disease.

Manifested as a reduction in volume in the retinal nerve fiber layer, these changes appear to track the aggregation of beta amyloid brain plaques well before cognitive problems arise – and can be easily measured with a piece of equipment already in many optometry offices, Peter J. Snyder, PhD, said at the Clinical Trials in Alzheimer’s Disease conference.

Courtesy Dr. Peter Synder

[email protected]

On Twitter @Alz_Gal

BOSTON – Changes in the retina seem to mirror changes that begin to reshape the brain in preclinical Alzheimer’s disease.

Manifested as a reduction in volume in the retinal nerve fiber layer, these changes appear to track the aggregation of beta amyloid brain plaques well before cognitive problems arise – and can be easily measured with a piece of equipment already in many optometry offices, Peter J. Snyder, PhD, said at the Clinical Trials in Alzheimer’s Disease conference.

Courtesy Dr. Peter Synder

[email protected]

On Twitter @Alz_Gal

During your career, you serve as staff member and leader to many different professional groups. Some are collaborative, collegial, and supportive. Others are competitive, antagonistic, or even combative. What are the benefits and downsides of each of these cultures and what can you do, as a hospitalist leader, to influence the character of your workplace?

• Unity of mission – In Boston, that was to “save lives,” and it motivated and activated the whole of the response.
• Generosity of spirit and action – Across the community, people were eager to assist in the response.
• Everyone stayed in their own lanes of responsibility and helped others succeed in theirs – There were law enforcement, medical, and resilience activities and the theme across the leaders was “how can I help make you a success?”
• No ego and no blame – There was a level of emotional intelligence and maturity among the leaders.
• A foundation of trusting relations – These leaders had known one another for years and, though the decisions were tough, they were confident in the motives and actions of the others.

While the discovery emerged from our crisis research, the findings equally apply to other, more routine work and interactions. Conduct your own assessment. Have you worked in groups in which these principles of swarm leadership characterized the experience? People were focused on a shared mission: They were available to assist one another; accomplished their work in ways that were respectful and supportive of their different responsibilities; did not claim undue credit or swipe at each another; and knew one another well enough to trust the others’ actions and motives.

The flip side of this continuum of collaboration and competition we term “suspicion leadership.” This is characterized by selfish ambitions; narcissistic actions; grabs for authority and resources; credit taking for the good and accusations for the bad; and an environment of mistrust and back stabbing.

Leaders influence the tone and tenor of their own group’s interactions as well as interactions among different working groups. As role models, if they articulate and demonstrate a mission that others can rally around, they forge that critical unity of mission. By contrast, suspicion leaders make it clear that “it is all about me and my priorities.” There is much work to be done, and swarm leaders ensure that people have the resources, autonomy, and support necessary to get the job done. On the other end, the work environment is burdened by the uncertainties about who does what and who is responsible. Swarm leaders are focused on “we” and suspicion leaders are caught up on “me.” There is no trust when people are suspicious of one another. Much can be accomplished when people believe in themselves, their colleagues, and the reasons that bring them together.

As a hospitalist leader, you influence where on this continuum your group will lie. It is your choice to be a role model for the principles of swarm, encouraging the same among others. When those principles become the beacons by which you work and relate, you will find an environment that inspires people to be and to do their best.

In the next column, how to build trust within your teams.

Dr. Marcus is director, Program on Health Care Negotiation and Conflict Resolution, at the Harvard T.H. Chan School of Public Health, in Boston.

During your career, you serve as staff member and leader to many different professional groups. Some are collaborative, collegial, and supportive. Others are competitive, antagonistic, or even combative. What are the benefits and downsides of each of these cultures and what can you do, as a hospitalist leader, to influence the character of your workplace?

• Unity of mission – In Boston, that was to “save lives,” and it motivated and activated the whole of the response.
• Generosity of spirit and action – Across the community, people were eager to assist in the response.
• Everyone stayed in their own lanes of responsibility and helped others succeed in theirs – There were law enforcement, medical, and resilience activities and the theme across the leaders was “how can I help make you a success?”
• No ego and no blame – There was a level of emotional intelligence and maturity among the leaders.
• A foundation of trusting relations – These leaders had known one another for years and, though the decisions were tough, they were confident in the motives and actions of the others.

While the discovery emerged from our crisis research, the findings equally apply to other, more routine work and interactions. Conduct your own assessment. Have you worked in groups in which these principles of swarm leadership characterized the experience? People were focused on a shared mission: They were available to assist one another; accomplished their work in ways that were respectful and supportive of their different responsibilities; did not claim undue credit or swipe at each another; and knew one another well enough to trust the others’ actions and motives.

The flip side of this continuum of collaboration and competition we term “suspicion leadership.” This is characterized by selfish ambitions; narcissistic actions; grabs for authority and resources; credit taking for the good and accusations for the bad; and an environment of mistrust and back stabbing.

Leaders influence the tone and tenor of their own group’s interactions as well as interactions among different working groups. As role models, if they articulate and demonstrate a mission that others can rally around, they forge that critical unity of mission. By contrast, suspicion leaders make it clear that “it is all about me and my priorities.” There is much work to be done, and swarm leaders ensure that people have the resources, autonomy, and support necessary to get the job done. On the other end, the work environment is burdened by the uncertainties about who does what and who is responsible. Swarm leaders are focused on “we” and suspicion leaders are caught up on “me.” There is no trust when people are suspicious of one another. Much can be accomplished when people believe in themselves, their colleagues, and the reasons that bring them together.

As a hospitalist leader, you influence where on this continuum your group will lie. It is your choice to be a role model for the principles of swarm, encouraging the same among others. When those principles become the beacons by which you work and relate, you will find an environment that inspires people to be and to do their best.

In the next column, how to build trust within your teams.

Dr. Marcus is director, Program on Health Care Negotiation and Conflict Resolution, at the Harvard T.H. Chan School of Public Health, in Boston.

During your career, you serve as staff member and leader to many different professional groups. Some are collaborative, collegial, and supportive. Others are competitive, antagonistic, or even combative. What are the benefits and downsides of each of these cultures and what can you do, as a hospitalist leader, to influence the character of your workplace?

• Unity of mission – In Boston, that was to “save lives,” and it motivated and activated the whole of the response.
• Generosity of spirit and action – Across the community, people were eager to assist in the response.
• Everyone stayed in their own lanes of responsibility and helped others succeed in theirs – There were law enforcement, medical, and resilience activities and the theme across the leaders was “how can I help make you a success?”
• No ego and no blame – There was a level of emotional intelligence and maturity among the leaders.
• A foundation of trusting relations – These leaders had known one another for years and, though the decisions were tough, they were confident in the motives and actions of the others.

While the discovery emerged from our crisis research, the findings equally apply to other, more routine work and interactions. Conduct your own assessment. Have you worked in groups in which these principles of swarm leadership characterized the experience? People were focused on a shared mission: They were available to assist one another; accomplished their work in ways that were respectful and supportive of their different responsibilities; did not claim undue credit or swipe at each another; and knew one another well enough to trust the others’ actions and motives.

The flip side of this continuum of collaboration and competition we term “suspicion leadership.” This is characterized by selfish ambitions; narcissistic actions; grabs for authority and resources; credit taking for the good and accusations for the bad; and an environment of mistrust and back stabbing.

Leaders influence the tone and tenor of their own group’s interactions as well as interactions among different working groups. As role models, if they articulate and demonstrate a mission that others can rally around, they forge that critical unity of mission. By contrast, suspicion leaders make it clear that “it is all about me and my priorities.” There is much work to be done, and swarm leaders ensure that people have the resources, autonomy, and support necessary to get the job done. On the other end, the work environment is burdened by the uncertainties about who does what and who is responsible. Swarm leaders are focused on “we” and suspicion leaders are caught up on “me.” There is no trust when people are suspicious of one another. Much can be accomplished when people believe in themselves, their colleagues, and the reasons that bring them together.

As a hospitalist leader, you influence where on this continuum your group will lie. It is your choice to be a role model for the principles of swarm, encouraging the same among others. When those principles become the beacons by which you work and relate, you will find an environment that inspires people to be and to do their best.

In the next column, how to build trust within your teams.

Dr. Marcus is director, Program on Health Care Negotiation and Conflict Resolution, at the Harvard T.H. Chan School of Public Health, in Boston.

SVS members, please remember to urge your physician assistants -- and other PAs you know who work in a vascular setting -- to apply to become charter members of the new SVS section created for them. The first step is becoming an affiliate member of the SVS. For our new charter PA members, SVS is waiving the application fee. For more information, email [email protected] or call the SVS Membership Department at 312-334-2313.

We welcome nurses and nurse practitioners as well. Please consider becoming a part of the Society for Vascular Nursing, which makes its management home at SVS.

SVS members, please remember to urge your physician assistants -- and other PAs you know who work in a vascular setting -- to apply to become charter members of the new SVS section created for them. The first step is becoming an affiliate member of the SVS. For our new charter PA members, SVS is waiving the application fee. For more information, email [email protected] or call the SVS Membership Department at 312-334-2313.

We welcome nurses and nurse practitioners as well. Please consider becoming a part of the Society for Vascular Nursing, which makes its management home at SVS.

SVS members, please remember to urge your physician assistants -- and other PAs you know who work in a vascular setting -- to apply to become charter members of the new SVS section created for them. The first step is becoming an affiliate member of the SVS. For our new charter PA members, SVS is waiving the application fee. For more information, email [email protected] or call the SVS Membership Department at 312-334-2313.

We welcome nurses and nurse practitioners as well. Please consider becoming a part of the Society for Vascular Nursing, which makes its management home at SVS.

Two months past its deadline, Congress has yet to fund the Children’s Health Insurance Program, leaving several states scrambling for cash.

Lawmakers grappling with the failed repeal of the Affordable Care Act allowed authorization of the program to lapse on Sept. 30. Although CHIP has always had broad bipartisan support, the House and Senate cannot agree on how to continue federal funding. And the Trump administration has been mostly silent on the issue.

CHIP benefits 9 million children nationwide and 370,000 pregnant women a year. It helps lower- and middle-income families who otherwise earn too much to be eligible for Medicaid. Like Medicaid, CHIP is paid for with state and federal funds, but the federal government covers close to 90% of the cost.

To keep the program going, states with unspent federal CHIP money have seen their excess sent to a handful of states running low on funds. But that is a bureaucratic Band-Aid; some large states are warning families they may not be able to rely on CHIP for much longer.

All told, the CMS has given out $1.2 billion in redistribution dollars since October. To keep the program going would cost the federal government $8.5 billion over 5 years, the Congressional Budget Office estimates.

Dec. 2 marked the 25th anniversary of Pennsylvania approving the original CHIP program, which served as a model for the national law, established in 1997. Since then, CHIP has been left in the fiscal lurch only once before. In 2007, CHIP went several weeks without funding authorization from Congress.

Here’s a quick look at what the shortfall may mean to daily life.
 

1. Are any kids hurting because Congress has failed to fund CHIP?

No. But states such as California will run out of money within weeks. That state alone accounts for nearly 15% of all children benefiting from CHIP. Without federal money, state programs could freeze enrollment or suspend operation.

2. What are states doing since Congress missed the deadline?

Most states are doing little except looking for other unspent federal funds or asking the federal government to send some unspent funds from other states. But some, such as Colorado, are sending warning letters to beneficiaries to tell them that the program could soon end and to look for alternatives. This could mean exploring the ACA marketplace for coverage or researching if a child qualifies for Medicaid.

Colorado said it has only enough CHIP funding to last through January and then the program, without federal dollars, will end.

Arizona officials announced Nov. 30 that it will use Medicaid funding to fill in the shortage of CHIP dollars to extend the life of its CHIP program.

Virginia officials plan to send out a similar notice to parents of CHIP members by early December.

Minnesota is keeping CHIP alive by paying the federal share with state funds.

In Oregon, Democratic Gov. Kate Brown recently said that she is ready to spend $35 million in state funds to keep CHIP running through December.

Nevada announced on Nov. 30 it had been approved for extra funding from the Centers for Medicare & Medicaid Services – nearly $5.7 million – which could keep CHIP alive through December and possibly January.

California, which leads the nation in CHIP enrollment, has received the lion’s share of CMS redistribution funds since October: nearly $692 million.

“Approximately 98% of the 1.3 million population now covered using CHIP funding would continue to receive coverage under the Medicaid program because of a legal obligation to cover them through September 2019,” said California Medicaid/CHIP spokesman Tony Cava. “If CHIP is not reauthorized, the governor and Legislature would need to deliberate on how best to address the population no longer eligible for federal CHIP funding.”
 

3. When is Congress likely to act?

Not sure. CHIP reauthorization could be included in an appropriations bill that Congress must pass to fund the government into 2018. (Congress now has funded the government through Dec. 8.) A “continuing resolution” bill would have to be approved by then to avert a government shutdown.

4. If CHIP is so popular among Republicans and Democrats, what’s the problem?

There is little debate about its worth and value, but the momentum on CHIP was lost amid disagreements over the Affordable Care Act. The House did extend authorization with a vote – mostly along party lines – on Nov. 3. The Senate itself has yet to vote. The Senate Finance Committee on Oct. 3 approved a bipartisan bill to extend the program for 5 years.

The sticking point is not whether to keep CHIP running but how to raise the cash needed. The House agreed to charge higher premiums to wealthier Medicare beneficiaries, cut money from the ACA’s preventive health fund and shorten the grace period for ACA enrollees who fail to make monthly premium payments.

Like the House bill, the Senate committee bill eliminated an ACA provision to increase CHIP matching funds – to states – by 23%. The increased funding would continue through fiscal year 2019 and fall to 11.5 percent in fiscal year 2020. It would be cut entirely in the following fiscal year.
 

5. How does CHIP differ based on where you live?

CHIP income eligibility levels vary by state. About 90% of children who qualify are from families earning 200% of poverty or less ($40,840 for a family of three). CHIP covers children up to age 19. But states have the option to cover pregnant women, and 18 states plus the District of Columbia do so.

Some states call CHIP by different names. For example, it is known as Hoosier Healthwise in Indiana, PeachCare for Kids in Georgia and KidsCare in Arizona.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Two months past its deadline, Congress has yet to fund the Children’s Health Insurance Program, leaving several states scrambling for cash.

Lawmakers grappling with the failed repeal of the Affordable Care Act allowed authorization of the program to lapse on Sept. 30. Although CHIP has always had broad bipartisan support, the House and Senate cannot agree on how to continue federal funding. And the Trump administration has been mostly silent on the issue.

CHIP benefits 9 million children nationwide and 370,000 pregnant women a year. It helps lower- and middle-income families who otherwise earn too much to be eligible for Medicaid. Like Medicaid, CHIP is paid for with state and federal funds, but the federal government covers close to 90% of the cost.

To keep the program going, states with unspent federal CHIP money have seen their excess sent to a handful of states running low on funds. But that is a bureaucratic Band-Aid; some large states are warning families they may not be able to rely on CHIP for much longer.

All told, the CMS has given out $1.2 billion in redistribution dollars since October. To keep the program going would cost the federal government $8.5 billion over 5 years, the Congressional Budget Office estimates.

Dec. 2 marked the 25th anniversary of Pennsylvania approving the original CHIP program, which served as a model for the national law, established in 1997. Since then, CHIP has been left in the fiscal lurch only once before. In 2007, CHIP went several weeks without funding authorization from Congress.

Here’s a quick look at what the shortfall may mean to daily life.
 

1. Are any kids hurting because Congress has failed to fund CHIP?

No. But states such as California will run out of money within weeks. That state alone accounts for nearly 15% of all children benefiting from CHIP. Without federal money, state programs could freeze enrollment or suspend operation.

2. What are states doing since Congress missed the deadline?

Most states are doing little except looking for other unspent federal funds or asking the federal government to send some unspent funds from other states. But some, such as Colorado, are sending warning letters to beneficiaries to tell them that the program could soon end and to look for alternatives. This could mean exploring the ACA marketplace for coverage or researching if a child qualifies for Medicaid.

Colorado said it has only enough CHIP funding to last through January and then the program, without federal dollars, will end.

Arizona officials announced Nov. 30 that it will use Medicaid funding to fill in the shortage of CHIP dollars to extend the life of its CHIP program.

Virginia officials plan to send out a similar notice to parents of CHIP members by early December.

Minnesota is keeping CHIP alive by paying the federal share with state funds.

In Oregon, Democratic Gov. Kate Brown recently said that she is ready to spend $35 million in state funds to keep CHIP running through December.

Nevada announced on Nov. 30 it had been approved for extra funding from the Centers for Medicare & Medicaid Services – nearly $5.7 million – which could keep CHIP alive through December and possibly January.

California, which leads the nation in CHIP enrollment, has received the lion’s share of CMS redistribution funds since October: nearly $692 million.

“Approximately 98% of the 1.3 million population now covered using CHIP funding would continue to receive coverage under the Medicaid program because of a legal obligation to cover them through September 2019,” said California Medicaid/CHIP spokesman Tony Cava. “If CHIP is not reauthorized, the governor and Legislature would need to deliberate on how best to address the population no longer eligible for federal CHIP funding.”
 

3. When is Congress likely to act?

Not sure. CHIP reauthorization could be included in an appropriations bill that Congress must pass to fund the government into 2018. (Congress now has funded the government through Dec. 8.) A “continuing resolution” bill would have to be approved by then to avert a government shutdown.

4. If CHIP is so popular among Republicans and Democrats, what’s the problem?

There is little debate about its worth and value, but the momentum on CHIP was lost amid disagreements over the Affordable Care Act. The House did extend authorization with a vote – mostly along party lines – on Nov. 3. The Senate itself has yet to vote. The Senate Finance Committee on Oct. 3 approved a bipartisan bill to extend the program for 5 years.

The sticking point is not whether to keep CHIP running but how to raise the cash needed. The House agreed to charge higher premiums to wealthier Medicare beneficiaries, cut money from the ACA’s preventive health fund and shorten the grace period for ACA enrollees who fail to make monthly premium payments.

Like the House bill, the Senate committee bill eliminated an ACA provision to increase CHIP matching funds – to states – by 23%. The increased funding would continue through fiscal year 2019 and fall to 11.5 percent in fiscal year 2020. It would be cut entirely in the following fiscal year.
 

5. How does CHIP differ based on where you live?

CHIP income eligibility levels vary by state. About 90% of children who qualify are from families earning 200% of poverty or less ($40,840 for a family of three). CHIP covers children up to age 19. But states have the option to cover pregnant women, and 18 states plus the District of Columbia do so.

Some states call CHIP by different names. For example, it is known as Hoosier Healthwise in Indiana, PeachCare for Kids in Georgia and KidsCare in Arizona.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Two months past its deadline, Congress has yet to fund the Children’s Health Insurance Program, leaving several states scrambling for cash.

Lawmakers grappling with the failed repeal of the Affordable Care Act allowed authorization of the program to lapse on Sept. 30. Although CHIP has always had broad bipartisan support, the House and Senate cannot agree on how to continue federal funding. And the Trump administration has been mostly silent on the issue.

CHIP benefits 9 million children nationwide and 370,000 pregnant women a year. It helps lower- and middle-income families who otherwise earn too much to be eligible for Medicaid. Like Medicaid, CHIP is paid for with state and federal funds, but the federal government covers close to 90% of the cost.

To keep the program going, states with unspent federal CHIP money have seen their excess sent to a handful of states running low on funds. But that is a bureaucratic Band-Aid; some large states are warning families they may not be able to rely on CHIP for much longer.

All told, the CMS has given out $1.2 billion in redistribution dollars since October. To keep the program going would cost the federal government $8.5 billion over 5 years, the Congressional Budget Office estimates.

Dec. 2 marked the 25th anniversary of Pennsylvania approving the original CHIP program, which served as a model for the national law, established in 1997. Since then, CHIP has been left in the fiscal lurch only once before. In 2007, CHIP went several weeks without funding authorization from Congress.

Here’s a quick look at what the shortfall may mean to daily life.
 

1. Are any kids hurting because Congress has failed to fund CHIP?

No. But states such as California will run out of money within weeks. That state alone accounts for nearly 15% of all children benefiting from CHIP. Without federal money, state programs could freeze enrollment or suspend operation.

2. What are states doing since Congress missed the deadline?

Most states are doing little except looking for other unspent federal funds or asking the federal government to send some unspent funds from other states. But some, such as Colorado, are sending warning letters to beneficiaries to tell them that the program could soon end and to look for alternatives. This could mean exploring the ACA marketplace for coverage or researching if a child qualifies for Medicaid.

Colorado said it has only enough CHIP funding to last through January and then the program, without federal dollars, will end.

Arizona officials announced Nov. 30 that it will use Medicaid funding to fill in the shortage of CHIP dollars to extend the life of its CHIP program.

Virginia officials plan to send out a similar notice to parents of CHIP members by early December.

Minnesota is keeping CHIP alive by paying the federal share with state funds.

In Oregon, Democratic Gov. Kate Brown recently said that she is ready to spend $35 million in state funds to keep CHIP running through December.

Nevada announced on Nov. 30 it had been approved for extra funding from the Centers for Medicare & Medicaid Services – nearly $5.7 million – which could keep CHIP alive through December and possibly January.

California, which leads the nation in CHIP enrollment, has received the lion’s share of CMS redistribution funds since October: nearly $692 million.

“Approximately 98% of the 1.3 million population now covered using CHIP funding would continue to receive coverage under the Medicaid program because of a legal obligation to cover them through September 2019,” said California Medicaid/CHIP spokesman Tony Cava. “If CHIP is not reauthorized, the governor and Legislature would need to deliberate on how best to address the population no longer eligible for federal CHIP funding.”
 

3. When is Congress likely to act?

Not sure. CHIP reauthorization could be included in an appropriations bill that Congress must pass to fund the government into 2018. (Congress now has funded the government through Dec. 8.) A “continuing resolution” bill would have to be approved by then to avert a government shutdown.

4. If CHIP is so popular among Republicans and Democrats, what’s the problem?

There is little debate about its worth and value, but the momentum on CHIP was lost amid disagreements over the Affordable Care Act. The House did extend authorization with a vote – mostly along party lines – on Nov. 3. The Senate itself has yet to vote. The Senate Finance Committee on Oct. 3 approved a bipartisan bill to extend the program for 5 years.

The sticking point is not whether to keep CHIP running but how to raise the cash needed. The House agreed to charge higher premiums to wealthier Medicare beneficiaries, cut money from the ACA’s preventive health fund and shorten the grace period for ACA enrollees who fail to make monthly premium payments.

Like the House bill, the Senate committee bill eliminated an ACA provision to increase CHIP matching funds – to states – by 23%. The increased funding would continue through fiscal year 2019 and fall to 11.5 percent in fiscal year 2020. It would be cut entirely in the following fiscal year.
 

5. How does CHIP differ based on where you live?

CHIP income eligibility levels vary by state. About 90% of children who qualify are from families earning 200% of poverty or less ($40,840 for a family of three). CHIP covers children up to age 19. But states have the option to cover pregnant women, and 18 states plus the District of Columbia do so.

Some states call CHIP by different names. For example, it is known as Hoosier Healthwise in Indiana, PeachCare for Kids in Georgia and KidsCare in Arizona.
 

KHN’s coverage of children’s health care issues is supported in part by the Heising-Simons Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The latest edition of the clinical practice guideline on larynx preservation strategies for the treatment of laryngeal cancer from the American Society of Clinical Oncology (ASCO) emphasizes that larynx preservation in patients with early stage disease does not compromise survival compared with total laryngectomy.

“The nuances of treatment selection, assessments of pretreatment voice and swallowing, and public awareness of new organ-preservation treatment and decision making have increased to the point that careful and individualized discussion with patients and families with the multidisciplinary treatment team is a critical element of modern care,” wrote Arlene A. Forastiere, MD, of Johns Hopkins Medicine in Baltimore, and her colleagues. The report was published in the Journal of Clinical Oncology.

Changes since the last guideline on the subject, issued in 2006, include evidence-based support for the use of endoscopic resection in patients with limited stage (T1 and T2) disease, and as an initial total laryngectomy therapy both in patients with stage T4a disease, and in those with severe laryngeal dysfunction prior to treatment.

Also new since the last guideline are recommendations for the use of positron-emission tomography imaging for evaluating the status of regional nodes after treatment, as well as guidance on the best techniques for evaluating voice and swallowing function.

While the initial recommendation that all patients with T1 and T2 laryngeal cancer should be treated with the intent to preserve the larynx has not changed, there is a new recommendation (1.3) stating that surgery may be more effective than radiotherapy for initial larynx preservation therapy, although this recommendation is based on retrospective data and may be affected by patient selection factors, the authors acknowledged. The new recommendation also notes that in an experienced operator’s hands, endoscopic resections can have outcomes that are equal to or better than those with open partial laryngectomy.

The initial recommendation stating that “[e]very effort should be made to avoid combining surgery with radiation therapy because functional outcomes may be compromised by combined-modality therapy; single-modality treatment is effective for limited-stage, invasive cancer of the larynx” remains unchanged.

There is also an updated recommendation that tumor-free margins should be the goal when surgery with larynx preservation intent is performed (1.4).

“Surgery that anticipates the need for postoperative [radiation therapy] to treat close or involved tumor margins or widespread dysplasia is not an acceptable treatment approach,” the guideline authors noted.

There are two other new recommendations including the opinion, based on evidence of benefits vs. harms, that total laryngectomy rather than larynx preservation may be associated with better survival and quality of life in patients with extensive T3 lesions, large T4 lesions, or in those who have poor pretreatment laryngeal function.

The third new recommendation is that “[a]s part of a comprehensive pretreatment evaluation, all patients should undergo a baseline assessment of voice and swallowing function, voice (use and requirements), and counseling with regard to the potential effect of treatment options on voice, swallowing, and quality of life.”

Among the updated recommendations are the following:

• An emphasis on the importance of considering a multiplicity of factors when choosing therapy for patients with limited-stage disease (1.7).

• The option of specialized organ-preservation procedures for a small number of patients with T3 or T4 primary site disease (2.4).

• A strong recommendation for the use of concurrent chemoradiotherapy compared with radiotherapy alone or sequential therapy (2.5).

• Elective neck dissection is not required for patients with clinically involved regional cervical nodes treated with definitive radiotherapy of chemoradiotherapy who have complete clinical, radiologic, and metabolic imaging (3.3).

• “Selection of therapy for an individual patient requires assessment by the multidisciplinary team as well as consideration of voice and swallowing function; patient comorbidity, psychosocial situation, and preferences; and local therapeutic expertise” (4.2).

The guideline development process was supported by ASCO. Dr, Forastiere disclosed employment and stock ownership in NantHealth. Many of her coauthors disclosed institutional funding, consultation/advising, travel support and expenses, honoraria, and or patents/royalties with multiple entities.

The latest edition of the clinical practice guideline on larynx preservation strategies for the treatment of laryngeal cancer from the American Society of Clinical Oncology (ASCO) emphasizes that larynx preservation in patients with early stage disease does not compromise survival compared with total laryngectomy.

“The nuances of treatment selection, assessments of pretreatment voice and swallowing, and public awareness of new organ-preservation treatment and decision making have increased to the point that careful and individualized discussion with patients and families with the multidisciplinary treatment team is a critical element of modern care,” wrote Arlene A. Forastiere, MD, of Johns Hopkins Medicine in Baltimore, and her colleagues. The report was published in the Journal of Clinical Oncology.

Changes since the last guideline on the subject, issued in 2006, include evidence-based support for the use of endoscopic resection in patients with limited stage (T1 and T2) disease, and as an initial total laryngectomy therapy both in patients with stage T4a disease, and in those with severe laryngeal dysfunction prior to treatment.

Also new since the last guideline are recommendations for the use of positron-emission tomography imaging for evaluating the status of regional nodes after treatment, as well as guidance on the best techniques for evaluating voice and swallowing function.

While the initial recommendation that all patients with T1 and T2 laryngeal cancer should be treated with the intent to preserve the larynx has not changed, there is a new recommendation (1.3) stating that surgery may be more effective than radiotherapy for initial larynx preservation therapy, although this recommendation is based on retrospective data and may be affected by patient selection factors, the authors acknowledged. The new recommendation also notes that in an experienced operator’s hands, endoscopic resections can have outcomes that are equal to or better than those with open partial laryngectomy.

The initial recommendation stating that “[e]very effort should be made to avoid combining surgery with radiation therapy because functional outcomes may be compromised by combined-modality therapy; single-modality treatment is effective for limited-stage, invasive cancer of the larynx” remains unchanged.

There is also an updated recommendation that tumor-free margins should be the goal when surgery with larynx preservation intent is performed (1.4).

“Surgery that anticipates the need for postoperative [radiation therapy] to treat close or involved tumor margins or widespread dysplasia is not an acceptable treatment approach,” the guideline authors noted.

There are two other new recommendations including the opinion, based on evidence of benefits vs. harms, that total laryngectomy rather than larynx preservation may be associated with better survival and quality of life in patients with extensive T3 lesions, large T4 lesions, or in those who have poor pretreatment laryngeal function.

The third new recommendation is that “[a]s part of a comprehensive pretreatment evaluation, all patients should undergo a baseline assessment of voice and swallowing function, voice (use and requirements), and counseling with regard to the potential effect of treatment options on voice, swallowing, and quality of life.”

Among the updated recommendations are the following:

• An emphasis on the importance of considering a multiplicity of factors when choosing therapy for patients with limited-stage disease (1.7).

• The option of specialized organ-preservation procedures for a small number of patients with T3 or T4 primary site disease (2.4).

• A strong recommendation for the use of concurrent chemoradiotherapy compared with radiotherapy alone or sequential therapy (2.5).

• Elective neck dissection is not required for patients with clinically involved regional cervical nodes treated with definitive radiotherapy of chemoradiotherapy who have complete clinical, radiologic, and metabolic imaging (3.3).

• “Selection of therapy for an individual patient requires assessment by the multidisciplinary team as well as consideration of voice and swallowing function; patient comorbidity, psychosocial situation, and preferences; and local therapeutic expertise” (4.2).

The guideline development process was supported by ASCO. Dr, Forastiere disclosed employment and stock ownership in NantHealth. Many of her coauthors disclosed institutional funding, consultation/advising, travel support and expenses, honoraria, and or patents/royalties with multiple entities.

The latest edition of the clinical practice guideline on larynx preservation strategies for the treatment of laryngeal cancer from the American Society of Clinical Oncology (ASCO) emphasizes that larynx preservation in patients with early stage disease does not compromise survival compared with total laryngectomy.

“The nuances of treatment selection, assessments of pretreatment voice and swallowing, and public awareness of new organ-preservation treatment and decision making have increased to the point that careful and individualized discussion with patients and families with the multidisciplinary treatment team is a critical element of modern care,” wrote Arlene A. Forastiere, MD, of Johns Hopkins Medicine in Baltimore, and her colleagues. The report was published in the Journal of Clinical Oncology.

Changes since the last guideline on the subject, issued in 2006, include evidence-based support for the use of endoscopic resection in patients with limited stage (T1 and T2) disease, and as an initial total laryngectomy therapy both in patients with stage T4a disease, and in those with severe laryngeal dysfunction prior to treatment.

Also new since the last guideline are recommendations for the use of positron-emission tomography imaging for evaluating the status of regional nodes after treatment, as well as guidance on the best techniques for evaluating voice and swallowing function.

While the initial recommendation that all patients with T1 and T2 laryngeal cancer should be treated with the intent to preserve the larynx has not changed, there is a new recommendation (1.3) stating that surgery may be more effective than radiotherapy for initial larynx preservation therapy, although this recommendation is based on retrospective data and may be affected by patient selection factors, the authors acknowledged. The new recommendation also notes that in an experienced operator’s hands, endoscopic resections can have outcomes that are equal to or better than those with open partial laryngectomy.

The initial recommendation stating that “[e]very effort should be made to avoid combining surgery with radiation therapy because functional outcomes may be compromised by combined-modality therapy; single-modality treatment is effective for limited-stage, invasive cancer of the larynx” remains unchanged.

There is also an updated recommendation that tumor-free margins should be the goal when surgery with larynx preservation intent is performed (1.4).

“Surgery that anticipates the need for postoperative [radiation therapy] to treat close or involved tumor margins or widespread dysplasia is not an acceptable treatment approach,” the guideline authors noted.

There are two other new recommendations including the opinion, based on evidence of benefits vs. harms, that total laryngectomy rather than larynx preservation may be associated with better survival and quality of life in patients with extensive T3 lesions, large T4 lesions, or in those who have poor pretreatment laryngeal function.

The third new recommendation is that “[a]s part of a comprehensive pretreatment evaluation, all patients should undergo a baseline assessment of voice and swallowing function, voice (use and requirements), and counseling with regard to the potential effect of treatment options on voice, swallowing, and quality of life.”

Among the updated recommendations are the following:

• An emphasis on the importance of considering a multiplicity of factors when choosing therapy for patients with limited-stage disease (1.7).

• The option of specialized organ-preservation procedures for a small number of patients with T3 or T4 primary site disease (2.4).

• A strong recommendation for the use of concurrent chemoradiotherapy compared with radiotherapy alone or sequential therapy (2.5).

• Elective neck dissection is not required for patients with clinically involved regional cervical nodes treated with definitive radiotherapy of chemoradiotherapy who have complete clinical, radiologic, and metabolic imaging (3.3).

• “Selection of therapy for an individual patient requires assessment by the multidisciplinary team as well as consideration of voice and swallowing function; patient comorbidity, psychosocial situation, and preferences; and local therapeutic expertise” (4.2).

The guideline development process was supported by ASCO. Dr, Forastiere disclosed employment and stock ownership in NantHealth. Many of her coauthors disclosed institutional funding, consultation/advising, travel support and expenses, honoraria, and or patents/royalties with multiple entities.