The VA Goes Its Own Way on Aducanumab

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In the Veterans Health Administration (VHA), the current prevalence of veterans with dementia is estimated to be about 10%.1 A 2013 report from the VHA Office of Policy and Planning projected a 22% increase in patients with dementia between 2020 and 2033. That increase amounts to between 276,000 and 335,000 additional veterans enrolled in the US Department of Veterans Affairs (VA) health care.2 Of course, these alarming statistics can in no way begin to convey the devastating biopsychosocial impact of Alzheimer disease and other dementias on veterans and their families. In many cases, veterans’ service to their country resulted in injuries and illnesses that increased the risk that they would develop dementia, such as traumatic brain injuries and posttraumatic stress disorder.3

Confronted with these concerning statistics, why didn’t VA Pharmacy Benefits Management (PBM) follow the US Food and Drug Administration (FDA) approval of aduncanumab-avwa for patients with dementia? Instead, PBM issued a monograph in July 2021 that recommended against providing aduncanumab-avwa to patients with Alzheimer dementia (mild or otherwise) or mild cognitive impairment, “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal.”4

In this editorial, I examine the reasons for the PBM recommendation, explain how the VA denial of approval for this new drug for dementia contravened that of the FDA and the ethical implications of this decision for veterans with dementia and the health care professionals (HCPs) who treat them.

The VA PBM national drug monographs are scientific reviews of clinical data supporting the potential inclusion of new medications in the VHA formulary.Aducanumab-avwa is a human monoclonal antibody. Its mechanism of action is to stimulate clearance of β-amyloid plaques from the brains of patients with Alzheimer disease. β-amyloid is a protein byproduct of amyloid precursor protein. Abnormal levels of β-amyloid build up in the brain of a patient with Alzheimer disease, forming clumps that disrupt neuronal connections that enable information transmission and other functions contributing to the death of brain cells.5

The FDA approved aducanumab on June 7, 2021, through the accelerated approval pathway.6 Drugs approved through the regular pathway must show a clinical benefit. Because detecting and demonstrating clinical benefit through research can be a lengthy process, in 1992 the FDA initiated the accelerated approval pathway. This alternative regulatory option permits the agency to approve a drug that “filled an unmet medical need” for a serious or life-threatening condition based on a surrogate endpoint.7 Examples of such endpoints are laboratory values, imaging evidence, physical signs, or other objective findings that are believed to predict a clinical benefit. In 2012, the FDA Safety Innovations Act expanded the basis for approval to an intermediate clinical endpoint: a measure of a therapeutic effect that demonstrates a “reasonable likelihood” of predicting clinical benefit.7

The FDA, unlike the PBM, found that aducanumab “provided a meaningful therapeutic advantage over existing treatments.” The FDA underscored that unlike other medications currently available to treat Alzheimer dementias that target symptoms, aducanumab acts on the underlying neurophysiology and neuropathology of the disease based on the decrease in β-amyloid plaques in participants in 2 large clinical trials. The FDA approved the drug for the treatment of patients with either mild cognitive impairment or in the mild state of Alzheimer dementia.

From the time of its announcement, the FDA decision to approve the drug was controversial and criticized in both professional articles and the news media. A particular poignant charge by Largent and Lynch was that the FDA had exploited the desperation of vulnerable patients with dementia and their families willing to try medications with unclear value and uncertain risk precisely because they believed they had no other viable options.8 Critics charged that the FDA took the unusual step of overruling the recommendations of a council of its senior advisors, claiming that there was insufficient evidence for approval; that there was a potential conflict of interest between the agency and the pharmaceutical industry; and that the FDA inappropriately used the accelerated approval pathway.9 In August 2021, in response to these critiques, the Office of the Inspector General announced that it would review the process the agency used in approving the drug.10 Nor was the VA alone in its refusal: The Centers for Medicare and Medicaid (CMS) has proposed to cover the drug for its beneficiaries enrolled in CMS-endorsed clinical trials with the caveat that the drug’s manufacturer, Biogen, must continue to conduct studies on the safety and effectiveness of the drug.11

Why did VHA come to a different scientific conclusion than that of the FDA? In reviewing the data from the 2 major studies, PBM did not find that this surrogate endpoint of reduction in β-amyloid plaques was a valid measure of a meaningful clinical benefit. Further, this lack of valid therapeutic change could not outweigh the risks of the amyloid-related imaging abnormalities (ARIA) in research participants. ARIA include cerebral vasogenic edema, effusions in sulci, microhemorrhages in the brain, and/or localized superficial siderosis. These findings are thought to be the result of the antibody binding to β-amyloid deposits that in turn increase cerebrovascular permeability.5

 

 



Thus, in not approving aducanumab, PBM and VHA leadership acted on the core bioethical principles of beneficence and nonmaleficence to prevent harms that proportionally outweighed benefits. Another ethical consideration for the VHA was that of distributive justice given the expense of the medication and the VHA obligation to be responsible stewards of public resources. At the time of the VHA decision, a year’s worth of aducanumab cost about $56,000: In December 2021, the manufacturer announced a dramatic decrease in the drug’s price.12 Although it may seem that fairness requires the VHA to provide any possible treatment for veterans whose cognitive impairment is in part an adverse effect of their time in uniform, a stronger counter argument is that the same high safety and scientific standard should be used for the approval of medications for patients with dementia as for any other disorder.

Among VHA HCPs and their patients with new and early diagnosed mild cognitive impairment or mild dementia, what is lacking in PBM’s clinical ethics analysis is the important principle of autonomy. PBM did carve out a space for the use of the drug in “highly selected patients by experts and centers that have the necessary diagnostic and management expertise.”5 The series of safety standards that must be met along with monitoring for the drug to be prescribed is PBM’s effort to obtain an equilibrium between preventing harm while respecting professional judgment and patient choice. PBM and VHA will reconsider its criteria if research shows improved effectiveness and safety. As with most debated decisions, for some patients and HCPs that balancing act may not have gone far enough, yet many believe that VHA for now is on the right side of the controversy.
References

1. Williamson V, Stevelink SAM, Greenberg K, Greenberg N. Prevalence of mental health disorders in elderly U.S. military veterans: a metaanalysis and systematic review. Am J Geriatr Psychiatry. 2018;26:534-545. doi:10.1016/j.jagp.2017.11.001

2. US Department of Veterans Affairs, Veterans Health Administration, Office of the Assistant Deputy Under Secretary for Health for Policy and Planning. Projections of the prevalence and incidence of dementias. Updated November 5, 2021. Accessed March 20, 2022. www.va.gov/geriatrics/GEC_Data_Reports.asp

3. Zhu CW, Sano M. Demographic, health, and exposure risks associated with cognitive loss, Alzheimer’s disease and other dementias in US military veterans. Front Psychiatry. 2021;12:610334. doi:10.3389/fpsyt.2021.610334

4. VHA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives. Aducanumab-avwa (ADUHELM) National Drug Monograph. Published July 2021. Accessed March 20, 2022. https://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/Aducanumab_ADUHELM_monograph_508.pdf

5. National Institutes of Health, National Institute on Aging. What happens to the brain in Alzheimer’s disease? Updated May 16, 2017. Accessed March 20, 2022. https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease

6. US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. News release. Published June 7, 2021. Accessed March 21, 2022. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug

7. US Food and Drug Administration. Accelerated approval. Updated January 4, 2018. Accessed March 21,2022.https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

8. Largent EL, Peterson E, Lynch HF. FDA approval and the ethics of desperation. JAMA Intern Med. 2021;181(12):1555-1556. doi:10.1001/jamainternmed.2021.6045

9. Belluck P, Kaplan S, Robbins R. How an unproven Alzheimer’s drug got approved. New York Times, Updated October 21, 2021. Accessed March 21, 2022. https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html

10. US Department of Health and Human Services, Office of the Inspector General. Review of the FDA’s accelerated approval pathway. Accessed March 20, 2022. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp

11. Centers for Medicare and Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease decision summary. Published January 11, 2022. Accessed March 21, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305

12. Gleckman H. What’s behind Biogen’s move to cut prices on its controversial Alzheimer’s drug alduhelm. Forbes. Published December 23, 2021. Accessed March 21,2022. https://www.forbes.com/sites/howardgleckman/2021/12/23/whats-behind-biogens-move-to-cut-prices-on-its-controversial-alzheimers-drug-aduhelm/?sh=498c6a235154

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In the Veterans Health Administration (VHA), the current prevalence of veterans with dementia is estimated to be about 10%.1 A 2013 report from the VHA Office of Policy and Planning projected a 22% increase in patients with dementia between 2020 and 2033. That increase amounts to between 276,000 and 335,000 additional veterans enrolled in the US Department of Veterans Affairs (VA) health care.2 Of course, these alarming statistics can in no way begin to convey the devastating biopsychosocial impact of Alzheimer disease and other dementias on veterans and their families. In many cases, veterans’ service to their country resulted in injuries and illnesses that increased the risk that they would develop dementia, such as traumatic brain injuries and posttraumatic stress disorder.3

Confronted with these concerning statistics, why didn’t VA Pharmacy Benefits Management (PBM) follow the US Food and Drug Administration (FDA) approval of aduncanumab-avwa for patients with dementia? Instead, PBM issued a monograph in July 2021 that recommended against providing aduncanumab-avwa to patients with Alzheimer dementia (mild or otherwise) or mild cognitive impairment, “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal.”4

In this editorial, I examine the reasons for the PBM recommendation, explain how the VA denial of approval for this new drug for dementia contravened that of the FDA and the ethical implications of this decision for veterans with dementia and the health care professionals (HCPs) who treat them.

The VA PBM national drug monographs are scientific reviews of clinical data supporting the potential inclusion of new medications in the VHA formulary.Aducanumab-avwa is a human monoclonal antibody. Its mechanism of action is to stimulate clearance of β-amyloid plaques from the brains of patients with Alzheimer disease. β-amyloid is a protein byproduct of amyloid precursor protein. Abnormal levels of β-amyloid build up in the brain of a patient with Alzheimer disease, forming clumps that disrupt neuronal connections that enable information transmission and other functions contributing to the death of brain cells.5

The FDA approved aducanumab on June 7, 2021, through the accelerated approval pathway.6 Drugs approved through the regular pathway must show a clinical benefit. Because detecting and demonstrating clinical benefit through research can be a lengthy process, in 1992 the FDA initiated the accelerated approval pathway. This alternative regulatory option permits the agency to approve a drug that “filled an unmet medical need” for a serious or life-threatening condition based on a surrogate endpoint.7 Examples of such endpoints are laboratory values, imaging evidence, physical signs, or other objective findings that are believed to predict a clinical benefit. In 2012, the FDA Safety Innovations Act expanded the basis for approval to an intermediate clinical endpoint: a measure of a therapeutic effect that demonstrates a “reasonable likelihood” of predicting clinical benefit.7

The FDA, unlike the PBM, found that aducanumab “provided a meaningful therapeutic advantage over existing treatments.” The FDA underscored that unlike other medications currently available to treat Alzheimer dementias that target symptoms, aducanumab acts on the underlying neurophysiology and neuropathology of the disease based on the decrease in β-amyloid plaques in participants in 2 large clinical trials. The FDA approved the drug for the treatment of patients with either mild cognitive impairment or in the mild state of Alzheimer dementia.

From the time of its announcement, the FDA decision to approve the drug was controversial and criticized in both professional articles and the news media. A particular poignant charge by Largent and Lynch was that the FDA had exploited the desperation of vulnerable patients with dementia and their families willing to try medications with unclear value and uncertain risk precisely because they believed they had no other viable options.8 Critics charged that the FDA took the unusual step of overruling the recommendations of a council of its senior advisors, claiming that there was insufficient evidence for approval; that there was a potential conflict of interest between the agency and the pharmaceutical industry; and that the FDA inappropriately used the accelerated approval pathway.9 In August 2021, in response to these critiques, the Office of the Inspector General announced that it would review the process the agency used in approving the drug.10 Nor was the VA alone in its refusal: The Centers for Medicare and Medicaid (CMS) has proposed to cover the drug for its beneficiaries enrolled in CMS-endorsed clinical trials with the caveat that the drug’s manufacturer, Biogen, must continue to conduct studies on the safety and effectiveness of the drug.11

Why did VHA come to a different scientific conclusion than that of the FDA? In reviewing the data from the 2 major studies, PBM did not find that this surrogate endpoint of reduction in β-amyloid plaques was a valid measure of a meaningful clinical benefit. Further, this lack of valid therapeutic change could not outweigh the risks of the amyloid-related imaging abnormalities (ARIA) in research participants. ARIA include cerebral vasogenic edema, effusions in sulci, microhemorrhages in the brain, and/or localized superficial siderosis. These findings are thought to be the result of the antibody binding to β-amyloid deposits that in turn increase cerebrovascular permeability.5

 

 



Thus, in not approving aducanumab, PBM and VHA leadership acted on the core bioethical principles of beneficence and nonmaleficence to prevent harms that proportionally outweighed benefits. Another ethical consideration for the VHA was that of distributive justice given the expense of the medication and the VHA obligation to be responsible stewards of public resources. At the time of the VHA decision, a year’s worth of aducanumab cost about $56,000: In December 2021, the manufacturer announced a dramatic decrease in the drug’s price.12 Although it may seem that fairness requires the VHA to provide any possible treatment for veterans whose cognitive impairment is in part an adverse effect of their time in uniform, a stronger counter argument is that the same high safety and scientific standard should be used for the approval of medications for patients with dementia as for any other disorder.

Among VHA HCPs and their patients with new and early diagnosed mild cognitive impairment or mild dementia, what is lacking in PBM’s clinical ethics analysis is the important principle of autonomy. PBM did carve out a space for the use of the drug in “highly selected patients by experts and centers that have the necessary diagnostic and management expertise.”5 The series of safety standards that must be met along with monitoring for the drug to be prescribed is PBM’s effort to obtain an equilibrium between preventing harm while respecting professional judgment and patient choice. PBM and VHA will reconsider its criteria if research shows improved effectiveness and safety. As with most debated decisions, for some patients and HCPs that balancing act may not have gone far enough, yet many believe that VHA for now is on the right side of the controversy.

In the Veterans Health Administration (VHA), the current prevalence of veterans with dementia is estimated to be about 10%.1 A 2013 report from the VHA Office of Policy and Planning projected a 22% increase in patients with dementia between 2020 and 2033. That increase amounts to between 276,000 and 335,000 additional veterans enrolled in the US Department of Veterans Affairs (VA) health care.2 Of course, these alarming statistics can in no way begin to convey the devastating biopsychosocial impact of Alzheimer disease and other dementias on veterans and their families. In many cases, veterans’ service to their country resulted in injuries and illnesses that increased the risk that they would develop dementia, such as traumatic brain injuries and posttraumatic stress disorder.3

Confronted with these concerning statistics, why didn’t VA Pharmacy Benefits Management (PBM) follow the US Food and Drug Administration (FDA) approval of aduncanumab-avwa for patients with dementia? Instead, PBM issued a monograph in July 2021 that recommended against providing aduncanumab-avwa to patients with Alzheimer dementia (mild or otherwise) or mild cognitive impairment, “given the lack of evidence of a robust and meaningful clinical benefit and the known safety signal.”4

In this editorial, I examine the reasons for the PBM recommendation, explain how the VA denial of approval for this new drug for dementia contravened that of the FDA and the ethical implications of this decision for veterans with dementia and the health care professionals (HCPs) who treat them.

The VA PBM national drug monographs are scientific reviews of clinical data supporting the potential inclusion of new medications in the VHA formulary.Aducanumab-avwa is a human monoclonal antibody. Its mechanism of action is to stimulate clearance of β-amyloid plaques from the brains of patients with Alzheimer disease. β-amyloid is a protein byproduct of amyloid precursor protein. Abnormal levels of β-amyloid build up in the brain of a patient with Alzheimer disease, forming clumps that disrupt neuronal connections that enable information transmission and other functions contributing to the death of brain cells.5

The FDA approved aducanumab on June 7, 2021, through the accelerated approval pathway.6 Drugs approved through the regular pathway must show a clinical benefit. Because detecting and demonstrating clinical benefit through research can be a lengthy process, in 1992 the FDA initiated the accelerated approval pathway. This alternative regulatory option permits the agency to approve a drug that “filled an unmet medical need” for a serious or life-threatening condition based on a surrogate endpoint.7 Examples of such endpoints are laboratory values, imaging evidence, physical signs, or other objective findings that are believed to predict a clinical benefit. In 2012, the FDA Safety Innovations Act expanded the basis for approval to an intermediate clinical endpoint: a measure of a therapeutic effect that demonstrates a “reasonable likelihood” of predicting clinical benefit.7

The FDA, unlike the PBM, found that aducanumab “provided a meaningful therapeutic advantage over existing treatments.” The FDA underscored that unlike other medications currently available to treat Alzheimer dementias that target symptoms, aducanumab acts on the underlying neurophysiology and neuropathology of the disease based on the decrease in β-amyloid plaques in participants in 2 large clinical trials. The FDA approved the drug for the treatment of patients with either mild cognitive impairment or in the mild state of Alzheimer dementia.

From the time of its announcement, the FDA decision to approve the drug was controversial and criticized in both professional articles and the news media. A particular poignant charge by Largent and Lynch was that the FDA had exploited the desperation of vulnerable patients with dementia and their families willing to try medications with unclear value and uncertain risk precisely because they believed they had no other viable options.8 Critics charged that the FDA took the unusual step of overruling the recommendations of a council of its senior advisors, claiming that there was insufficient evidence for approval; that there was a potential conflict of interest between the agency and the pharmaceutical industry; and that the FDA inappropriately used the accelerated approval pathway.9 In August 2021, in response to these critiques, the Office of the Inspector General announced that it would review the process the agency used in approving the drug.10 Nor was the VA alone in its refusal: The Centers for Medicare and Medicaid (CMS) has proposed to cover the drug for its beneficiaries enrolled in CMS-endorsed clinical trials with the caveat that the drug’s manufacturer, Biogen, must continue to conduct studies on the safety and effectiveness of the drug.11

Why did VHA come to a different scientific conclusion than that of the FDA? In reviewing the data from the 2 major studies, PBM did not find that this surrogate endpoint of reduction in β-amyloid plaques was a valid measure of a meaningful clinical benefit. Further, this lack of valid therapeutic change could not outweigh the risks of the amyloid-related imaging abnormalities (ARIA) in research participants. ARIA include cerebral vasogenic edema, effusions in sulci, microhemorrhages in the brain, and/or localized superficial siderosis. These findings are thought to be the result of the antibody binding to β-amyloid deposits that in turn increase cerebrovascular permeability.5

 

 



Thus, in not approving aducanumab, PBM and VHA leadership acted on the core bioethical principles of beneficence and nonmaleficence to prevent harms that proportionally outweighed benefits. Another ethical consideration for the VHA was that of distributive justice given the expense of the medication and the VHA obligation to be responsible stewards of public resources. At the time of the VHA decision, a year’s worth of aducanumab cost about $56,000: In December 2021, the manufacturer announced a dramatic decrease in the drug’s price.12 Although it may seem that fairness requires the VHA to provide any possible treatment for veterans whose cognitive impairment is in part an adverse effect of their time in uniform, a stronger counter argument is that the same high safety and scientific standard should be used for the approval of medications for patients with dementia as for any other disorder.

Among VHA HCPs and their patients with new and early diagnosed mild cognitive impairment or mild dementia, what is lacking in PBM’s clinical ethics analysis is the important principle of autonomy. PBM did carve out a space for the use of the drug in “highly selected patients by experts and centers that have the necessary diagnostic and management expertise.”5 The series of safety standards that must be met along with monitoring for the drug to be prescribed is PBM’s effort to obtain an equilibrium between preventing harm while respecting professional judgment and patient choice. PBM and VHA will reconsider its criteria if research shows improved effectiveness and safety. As with most debated decisions, for some patients and HCPs that balancing act may not have gone far enough, yet many believe that VHA for now is on the right side of the controversy.
References

1. Williamson V, Stevelink SAM, Greenberg K, Greenberg N. Prevalence of mental health disorders in elderly U.S. military veterans: a metaanalysis and systematic review. Am J Geriatr Psychiatry. 2018;26:534-545. doi:10.1016/j.jagp.2017.11.001

2. US Department of Veterans Affairs, Veterans Health Administration, Office of the Assistant Deputy Under Secretary for Health for Policy and Planning. Projections of the prevalence and incidence of dementias. Updated November 5, 2021. Accessed March 20, 2022. www.va.gov/geriatrics/GEC_Data_Reports.asp

3. Zhu CW, Sano M. Demographic, health, and exposure risks associated with cognitive loss, Alzheimer’s disease and other dementias in US military veterans. Front Psychiatry. 2021;12:610334. doi:10.3389/fpsyt.2021.610334

4. VHA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives. Aducanumab-avwa (ADUHELM) National Drug Monograph. Published July 2021. Accessed March 20, 2022. https://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/Aducanumab_ADUHELM_monograph_508.pdf

5. National Institutes of Health, National Institute on Aging. What happens to the brain in Alzheimer’s disease? Updated May 16, 2017. Accessed March 20, 2022. https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease

6. US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. News release. Published June 7, 2021. Accessed March 21, 2022. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug

7. US Food and Drug Administration. Accelerated approval. Updated January 4, 2018. Accessed March 21,2022.https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

8. Largent EL, Peterson E, Lynch HF. FDA approval and the ethics of desperation. JAMA Intern Med. 2021;181(12):1555-1556. doi:10.1001/jamainternmed.2021.6045

9. Belluck P, Kaplan S, Robbins R. How an unproven Alzheimer’s drug got approved. New York Times, Updated October 21, 2021. Accessed March 21, 2022. https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html

10. US Department of Health and Human Services, Office of the Inspector General. Review of the FDA’s accelerated approval pathway. Accessed March 20, 2022. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp

11. Centers for Medicare and Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease decision summary. Published January 11, 2022. Accessed March 21, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305

12. Gleckman H. What’s behind Biogen’s move to cut prices on its controversial Alzheimer’s drug alduhelm. Forbes. Published December 23, 2021. Accessed March 21,2022. https://www.forbes.com/sites/howardgleckman/2021/12/23/whats-behind-biogens-move-to-cut-prices-on-its-controversial-alzheimers-drug-aduhelm/?sh=498c6a235154

References

1. Williamson V, Stevelink SAM, Greenberg K, Greenberg N. Prevalence of mental health disorders in elderly U.S. military veterans: a metaanalysis and systematic review. Am J Geriatr Psychiatry. 2018;26:534-545. doi:10.1016/j.jagp.2017.11.001

2. US Department of Veterans Affairs, Veterans Health Administration, Office of the Assistant Deputy Under Secretary for Health for Policy and Planning. Projections of the prevalence and incidence of dementias. Updated November 5, 2021. Accessed March 20, 2022. www.va.gov/geriatrics/GEC_Data_Reports.asp

3. Zhu CW, Sano M. Demographic, health, and exposure risks associated with cognitive loss, Alzheimer’s disease and other dementias in US military veterans. Front Psychiatry. 2021;12:610334. doi:10.3389/fpsyt.2021.610334

4. VHA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives. Aducanumab-avwa (ADUHELM) National Drug Monograph. Published July 2021. Accessed March 20, 2022. https://www.pbm.va.gov/PBM/clinicalguidance/drugmonographs/Aducanumab_ADUHELM_monograph_508.pdf

5. National Institutes of Health, National Institute on Aging. What happens to the brain in Alzheimer’s disease? Updated May 16, 2017. Accessed March 20, 2022. https://www.nia.nih.gov/health/what-happens-brain-alzheimers-disease

6. US Food and Drug Administration. FDA grants accelerated approval for Alzheimer’s drug. News release. Published June 7, 2021. Accessed March 21, 2022. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug

7. US Food and Drug Administration. Accelerated approval. Updated January 4, 2018. Accessed March 21,2022.https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval

8. Largent EL, Peterson E, Lynch HF. FDA approval and the ethics of desperation. JAMA Intern Med. 2021;181(12):1555-1556. doi:10.1001/jamainternmed.2021.6045

9. Belluck P, Kaplan S, Robbins R. How an unproven Alzheimer’s drug got approved. New York Times, Updated October 21, 2021. Accessed March 21, 2022. https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html

10. US Department of Health and Human Services, Office of the Inspector General. Review of the FDA’s accelerated approval pathway. Accessed March 20, 2022. https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000608.asp

11. Centers for Medicare and Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease decision summary. Published January 11, 2022. Accessed March 21, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305

12. Gleckman H. What’s behind Biogen’s move to cut prices on its controversial Alzheimer’s drug alduhelm. Forbes. Published December 23, 2021. Accessed March 21,2022. https://www.forbes.com/sites/howardgleckman/2021/12/23/whats-behind-biogens-move-to-cut-prices-on-its-controversial-alzheimers-drug-aduhelm/?sh=498c6a235154

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A Pioneer in Women’s Federal Practice

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March is Women’s History Month. Many women have served in all branches of government health care over centuries and are worthy of celebrating. These nurses, physicians, pharmacists, and other allied health professionals devoted their time and talents, compassion, and competence to deliver and improve the care of wounded service members, disabled veterans, and the underresourced in our communities. To honor the collective contribution of women to federal practice in the Indian Health Service, Public Health Service Core, US Department of Veterans Affairs (VA) and the US Department of Defense, this column examines one pioneer in women’s federal practice—Margaret D. Craighill, MD—who epitomizes the spirit of the selfless dedication that generations of women have given to public service. Craighill is an ideal choice to represent this noble cadre of women as her career spanned active military duty, public health, and the Veterans Health Administration.

Craighill was a graduate of several of the finest institutions of medical training in the United States. Born in Southport, North Carolina, in 1898, she earned her undergraduate degree Phi Beta Kappa and master’s degree from the University of Wisconsin.2 She set her sights on becoming a physician at a period in American history when many prominent medical schools accepted few women. A marked exception—due to the fund raising and lobbying of influential women—was the prestigious Johns Hopkins University School of Medicine.3 She graduated in 1924 and held a postgraduate position at Yale Medical School. She then worked as a physiologist at a military arsenal, a pathologist, a general surgeon, and completed a residency in obstetrics and gynecology. This broad training gave her the diverse expertise she would need for her future work.4

Craighill came from a military family: Her father was a colonel in the engineering corps, and her grandfather rose to become chief engineer of the Army.5 Along with many of America’s best and brightest, Craighill left her successful medical career as dean of the Women’s Medical College of Pennsylvania to join the war effort. Author Alan G. Knight points out, more than in civilian medicine, gender stereotypes kept women from entering the military: Women were expected and accepted as nurses, not doctors.5 But in 1943 Congress passed and President Roosevelt signed the Sparkman-Johnson Bill, enabling women to enter the then all-male Army and Navy Medical Corps. Craighill took advantage of this opportunity and accepted an appointment to the Women’s Army Corps (WAC) as a major in 1943 at age 45 years, becoming the first woman physician to be commissioned an officer in the Army.

Major Craighill’s initial assignment was to the Office of the Surgeon General in the Preventive Medicine Division as the consultant for health and welfare of women. Here, she served as liaison to another innovation in women’s history in military medicine—the WAC. Journeying 56,000 miles to war zones in multiple countries, she assessed the health of 160,000 Army nurses and other staff whose focus was public health and infectious disease and hygiene. The history of women in medicine in and out of federal service is marked by overcoming innumerable biases and barriers. Craighill faced the prevailing presumption that women were unfit for military duty. In an early example of evidence-based medicine, she disproved this theory, showing that women were faring well doing hard jobs in tough environments.4

Their fortitude is more remarkable considering induction examinations for women during World War II were cursory and not tailored to address women’s health care needs. Based on her visits to WACs in theater and at home, Craighill observed recruits suffering from previously undiagnosed gynecologic and psychiatric conditions that adversely affected their health and function. She advocated for comprehensive standardized examinations that would detect many of these disorders.5

Craighill promoted other prejudices of her era. WAC command wanted to win public approval of women in the service and was concerned that lesbian relationships and “heterosexual promiscuity” would damage their public relations aims. They pressured Craighill to develop induction examinations that would screen lesbians and women with behavioral problems. She urged tolerance of homosexual behavior until it was proven.

Though clearly discriminatory and personally offensive to gay persons in federal service, we must recognize that only last year did the Pentagon move to overturn the prior administration’s prohibition against transgender persons serving in uniform.6 In this light Craighill, as the first female physician-leader in a 1940s military, adopted a relatively progressive stance.

Craighill rose to the rank of lieutenant colonel and received the Legion of Merit award for her exemplary wartime service. In 1945, she earned another first when she was appointed to be a consultant on the medical care of women veterans. For women veterans, gaining access to newly earned benefits and receiving appropriate care were serious problems that Craighill worked to solve. For many women veterans, those challenges remain, and Craighill’s legacy summons us to take up the charge to empower women in federal health professions to enhance the quality of care women veterans receive in all sectors of US medicine.

Critics and advocates agree that the VA still has a long way to go to achieve equity and excellence in our care for women veterans.7,8 Craighill’s position stands as a landmark in this effort. During her VA tenure, Craighill entered a residency in the first class of the Menninger School of Psychiatry in Topeka, Kansas, and completed psychoanalytic training. Her wartime experiences had convinced her of the need to provide high-quality mental health care to women veterans. She put her new psychosomatic knowledge and skills to use, serving as the chief of a women’s health clinic at the VA Hospital in Topeka and published several important scholarly papers.5,9Craighill went on to have a distinguished career in academic medicine, underscoring the long and valuable relationship of US medicine and the scholarly medical community. Once her psychiatric training was finished, she returned to private practice, ending her career as chief psychiatrist at Connecticut College for Women.

Craighill made a significant contribution to the role of women in federal practice. She was a visionary in her conviction that women, whether physicians, nurses, or other health care professionals, had the gifts and the grit to serve with distinction and valor and that their military service entitled them in war and peace to gender-sensitive health care. As the epigraph for this editorial shows, Craighill knew the path for women in federal practice or service while not easy is well worth treading. Her pioneering career can inspire all those women who today and in the future choose to follow in her footsteps.

References

1. Bellafaire J, Graf MH. Women Doctors in War. Texas A&M University Press; 2009:61.

2. Nuland SB. Doctors: The Biography of Medicine. Alfred A. Knopf; 1988:399-405.

3. Dr. Margaret D. Craighill, at 78, former dean of medical college. Obituary. New York Times, July 26, 1977. Accessed February 24, 2022. https://www.nytimes.com/1977/07/26/archives/dr-margaret-d-craighill-at-78-former-dean-of-medical-college.html

4. US Library of Medicine. Changing the face of medicine: Dr. Margaret D. Craighill. Updated June 03, 2015. Accessed February 23, 2022. https://cfmedicine.nlm.nih.gov/physicians/biography_72.html

5. Knight AG. Dr. Margaret D. Craighill, M.D. On Point. 2018;23(4):19-22. Accessed February 24, 2022. https://www.jstor.org/stable/26478427.

6. Wamsley L. Pentagon releases new policies enabling transgender people to serve in the military. Updated March 31, 2021. Accessed February 23, 2022. https://www.npr.org/2021/03/31/983118029/pentagon-releases-new-policies-enabling-transgender-people-to-serve-in-the-milit

7. Shane L. Is VA shortchanging women’s health programs. Military Times. Published February 28, 2019. Accessed February 24, 2022. https://www.militarytimes.com/news/pentagon-congress/2019/02/28/is-va-spending-enough-on-womens-health-programs

8. Marshall V, Stryczek KC, Haverhals L, et al. The focus they deserve: improving women veterans’ health care access. Womens Health Issues. 2021;31(4):399-407. doi:10.1016/j.whi.2020.12.011

9. Craighill MD. Psychiatric aspects of women serving in the Army. Am J Psychiatry. 1947;104(4):226-230. doi:10.1176/ajp.104.4.226

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March is Women’s History Month. Many women have served in all branches of government health care over centuries and are worthy of celebrating. These nurses, physicians, pharmacists, and other allied health professionals devoted their time and talents, compassion, and competence to deliver and improve the care of wounded service members, disabled veterans, and the underresourced in our communities. To honor the collective contribution of women to federal practice in the Indian Health Service, Public Health Service Core, US Department of Veterans Affairs (VA) and the US Department of Defense, this column examines one pioneer in women’s federal practice—Margaret D. Craighill, MD—who epitomizes the spirit of the selfless dedication that generations of women have given to public service. Craighill is an ideal choice to represent this noble cadre of women as her career spanned active military duty, public health, and the Veterans Health Administration.

Craighill was a graduate of several of the finest institutions of medical training in the United States. Born in Southport, North Carolina, in 1898, she earned her undergraduate degree Phi Beta Kappa and master’s degree from the University of Wisconsin.2 She set her sights on becoming a physician at a period in American history when many prominent medical schools accepted few women. A marked exception—due to the fund raising and lobbying of influential women—was the prestigious Johns Hopkins University School of Medicine.3 She graduated in 1924 and held a postgraduate position at Yale Medical School. She then worked as a physiologist at a military arsenal, a pathologist, a general surgeon, and completed a residency in obstetrics and gynecology. This broad training gave her the diverse expertise she would need for her future work.4

Craighill came from a military family: Her father was a colonel in the engineering corps, and her grandfather rose to become chief engineer of the Army.5 Along with many of America’s best and brightest, Craighill left her successful medical career as dean of the Women’s Medical College of Pennsylvania to join the war effort. Author Alan G. Knight points out, more than in civilian medicine, gender stereotypes kept women from entering the military: Women were expected and accepted as nurses, not doctors.5 But in 1943 Congress passed and President Roosevelt signed the Sparkman-Johnson Bill, enabling women to enter the then all-male Army and Navy Medical Corps. Craighill took advantage of this opportunity and accepted an appointment to the Women’s Army Corps (WAC) as a major in 1943 at age 45 years, becoming the first woman physician to be commissioned an officer in the Army.

Major Craighill’s initial assignment was to the Office of the Surgeon General in the Preventive Medicine Division as the consultant for health and welfare of women. Here, she served as liaison to another innovation in women’s history in military medicine—the WAC. Journeying 56,000 miles to war zones in multiple countries, she assessed the health of 160,000 Army nurses and other staff whose focus was public health and infectious disease and hygiene. The history of women in medicine in and out of federal service is marked by overcoming innumerable biases and barriers. Craighill faced the prevailing presumption that women were unfit for military duty. In an early example of evidence-based medicine, she disproved this theory, showing that women were faring well doing hard jobs in tough environments.4

Their fortitude is more remarkable considering induction examinations for women during World War II were cursory and not tailored to address women’s health care needs. Based on her visits to WACs in theater and at home, Craighill observed recruits suffering from previously undiagnosed gynecologic and psychiatric conditions that adversely affected their health and function. She advocated for comprehensive standardized examinations that would detect many of these disorders.5

Craighill promoted other prejudices of her era. WAC command wanted to win public approval of women in the service and was concerned that lesbian relationships and “heterosexual promiscuity” would damage their public relations aims. They pressured Craighill to develop induction examinations that would screen lesbians and women with behavioral problems. She urged tolerance of homosexual behavior until it was proven.

Though clearly discriminatory and personally offensive to gay persons in federal service, we must recognize that only last year did the Pentagon move to overturn the prior administration’s prohibition against transgender persons serving in uniform.6 In this light Craighill, as the first female physician-leader in a 1940s military, adopted a relatively progressive stance.

Craighill rose to the rank of lieutenant colonel and received the Legion of Merit award for her exemplary wartime service. In 1945, she earned another first when she was appointed to be a consultant on the medical care of women veterans. For women veterans, gaining access to newly earned benefits and receiving appropriate care were serious problems that Craighill worked to solve. For many women veterans, those challenges remain, and Craighill’s legacy summons us to take up the charge to empower women in federal health professions to enhance the quality of care women veterans receive in all sectors of US medicine.

Critics and advocates agree that the VA still has a long way to go to achieve equity and excellence in our care for women veterans.7,8 Craighill’s position stands as a landmark in this effort. During her VA tenure, Craighill entered a residency in the first class of the Menninger School of Psychiatry in Topeka, Kansas, and completed psychoanalytic training. Her wartime experiences had convinced her of the need to provide high-quality mental health care to women veterans. She put her new psychosomatic knowledge and skills to use, serving as the chief of a women’s health clinic at the VA Hospital in Topeka and published several important scholarly papers.5,9Craighill went on to have a distinguished career in academic medicine, underscoring the long and valuable relationship of US medicine and the scholarly medical community. Once her psychiatric training was finished, she returned to private practice, ending her career as chief psychiatrist at Connecticut College for Women.

Craighill made a significant contribution to the role of women in federal practice. She was a visionary in her conviction that women, whether physicians, nurses, or other health care professionals, had the gifts and the grit to serve with distinction and valor and that their military service entitled them in war and peace to gender-sensitive health care. As the epigraph for this editorial shows, Craighill knew the path for women in federal practice or service while not easy is well worth treading. Her pioneering career can inspire all those women who today and in the future choose to follow in her footsteps.

March is Women’s History Month. Many women have served in all branches of government health care over centuries and are worthy of celebrating. These nurses, physicians, pharmacists, and other allied health professionals devoted their time and talents, compassion, and competence to deliver and improve the care of wounded service members, disabled veterans, and the underresourced in our communities. To honor the collective contribution of women to federal practice in the Indian Health Service, Public Health Service Core, US Department of Veterans Affairs (VA) and the US Department of Defense, this column examines one pioneer in women’s federal practice—Margaret D. Craighill, MD—who epitomizes the spirit of the selfless dedication that generations of women have given to public service. Craighill is an ideal choice to represent this noble cadre of women as her career spanned active military duty, public health, and the Veterans Health Administration.

Craighill was a graduate of several of the finest institutions of medical training in the United States. Born in Southport, North Carolina, in 1898, she earned her undergraduate degree Phi Beta Kappa and master’s degree from the University of Wisconsin.2 She set her sights on becoming a physician at a period in American history when many prominent medical schools accepted few women. A marked exception—due to the fund raising and lobbying of influential women—was the prestigious Johns Hopkins University School of Medicine.3 She graduated in 1924 and held a postgraduate position at Yale Medical School. She then worked as a physiologist at a military arsenal, a pathologist, a general surgeon, and completed a residency in obstetrics and gynecology. This broad training gave her the diverse expertise she would need for her future work.4

Craighill came from a military family: Her father was a colonel in the engineering corps, and her grandfather rose to become chief engineer of the Army.5 Along with many of America’s best and brightest, Craighill left her successful medical career as dean of the Women’s Medical College of Pennsylvania to join the war effort. Author Alan G. Knight points out, more than in civilian medicine, gender stereotypes kept women from entering the military: Women were expected and accepted as nurses, not doctors.5 But in 1943 Congress passed and President Roosevelt signed the Sparkman-Johnson Bill, enabling women to enter the then all-male Army and Navy Medical Corps. Craighill took advantage of this opportunity and accepted an appointment to the Women’s Army Corps (WAC) as a major in 1943 at age 45 years, becoming the first woman physician to be commissioned an officer in the Army.

Major Craighill’s initial assignment was to the Office of the Surgeon General in the Preventive Medicine Division as the consultant for health and welfare of women. Here, she served as liaison to another innovation in women’s history in military medicine—the WAC. Journeying 56,000 miles to war zones in multiple countries, she assessed the health of 160,000 Army nurses and other staff whose focus was public health and infectious disease and hygiene. The history of women in medicine in and out of federal service is marked by overcoming innumerable biases and barriers. Craighill faced the prevailing presumption that women were unfit for military duty. In an early example of evidence-based medicine, she disproved this theory, showing that women were faring well doing hard jobs in tough environments.4

Their fortitude is more remarkable considering induction examinations for women during World War II were cursory and not tailored to address women’s health care needs. Based on her visits to WACs in theater and at home, Craighill observed recruits suffering from previously undiagnosed gynecologic and psychiatric conditions that adversely affected their health and function. She advocated for comprehensive standardized examinations that would detect many of these disorders.5

Craighill promoted other prejudices of her era. WAC command wanted to win public approval of women in the service and was concerned that lesbian relationships and “heterosexual promiscuity” would damage their public relations aims. They pressured Craighill to develop induction examinations that would screen lesbians and women with behavioral problems. She urged tolerance of homosexual behavior until it was proven.

Though clearly discriminatory and personally offensive to gay persons in federal service, we must recognize that only last year did the Pentagon move to overturn the prior administration’s prohibition against transgender persons serving in uniform.6 In this light Craighill, as the first female physician-leader in a 1940s military, adopted a relatively progressive stance.

Craighill rose to the rank of lieutenant colonel and received the Legion of Merit award for her exemplary wartime service. In 1945, she earned another first when she was appointed to be a consultant on the medical care of women veterans. For women veterans, gaining access to newly earned benefits and receiving appropriate care were serious problems that Craighill worked to solve. For many women veterans, those challenges remain, and Craighill’s legacy summons us to take up the charge to empower women in federal health professions to enhance the quality of care women veterans receive in all sectors of US medicine.

Critics and advocates agree that the VA still has a long way to go to achieve equity and excellence in our care for women veterans.7,8 Craighill’s position stands as a landmark in this effort. During her VA tenure, Craighill entered a residency in the first class of the Menninger School of Psychiatry in Topeka, Kansas, and completed psychoanalytic training. Her wartime experiences had convinced her of the need to provide high-quality mental health care to women veterans. She put her new psychosomatic knowledge and skills to use, serving as the chief of a women’s health clinic at the VA Hospital in Topeka and published several important scholarly papers.5,9Craighill went on to have a distinguished career in academic medicine, underscoring the long and valuable relationship of US medicine and the scholarly medical community. Once her psychiatric training was finished, she returned to private practice, ending her career as chief psychiatrist at Connecticut College for Women.

Craighill made a significant contribution to the role of women in federal practice. She was a visionary in her conviction that women, whether physicians, nurses, or other health care professionals, had the gifts and the grit to serve with distinction and valor and that their military service entitled them in war and peace to gender-sensitive health care. As the epigraph for this editorial shows, Craighill knew the path for women in federal practice or service while not easy is well worth treading. Her pioneering career can inspire all those women who today and in the future choose to follow in her footsteps.

References

1. Bellafaire J, Graf MH. Women Doctors in War. Texas A&M University Press; 2009:61.

2. Nuland SB. Doctors: The Biography of Medicine. Alfred A. Knopf; 1988:399-405.

3. Dr. Margaret D. Craighill, at 78, former dean of medical college. Obituary. New York Times, July 26, 1977. Accessed February 24, 2022. https://www.nytimes.com/1977/07/26/archives/dr-margaret-d-craighill-at-78-former-dean-of-medical-college.html

4. US Library of Medicine. Changing the face of medicine: Dr. Margaret D. Craighill. Updated June 03, 2015. Accessed February 23, 2022. https://cfmedicine.nlm.nih.gov/physicians/biography_72.html

5. Knight AG. Dr. Margaret D. Craighill, M.D. On Point. 2018;23(4):19-22. Accessed February 24, 2022. https://www.jstor.org/stable/26478427.

6. Wamsley L. Pentagon releases new policies enabling transgender people to serve in the military. Updated March 31, 2021. Accessed February 23, 2022. https://www.npr.org/2021/03/31/983118029/pentagon-releases-new-policies-enabling-transgender-people-to-serve-in-the-milit

7. Shane L. Is VA shortchanging women’s health programs. Military Times. Published February 28, 2019. Accessed February 24, 2022. https://www.militarytimes.com/news/pentagon-congress/2019/02/28/is-va-spending-enough-on-womens-health-programs

8. Marshall V, Stryczek KC, Haverhals L, et al. The focus they deserve: improving women veterans’ health care access. Womens Health Issues. 2021;31(4):399-407. doi:10.1016/j.whi.2020.12.011

9. Craighill MD. Psychiatric aspects of women serving in the Army. Am J Psychiatry. 1947;104(4):226-230. doi:10.1176/ajp.104.4.226

References

1. Bellafaire J, Graf MH. Women Doctors in War. Texas A&M University Press; 2009:61.

2. Nuland SB. Doctors: The Biography of Medicine. Alfred A. Knopf; 1988:399-405.

3. Dr. Margaret D. Craighill, at 78, former dean of medical college. Obituary. New York Times, July 26, 1977. Accessed February 24, 2022. https://www.nytimes.com/1977/07/26/archives/dr-margaret-d-craighill-at-78-former-dean-of-medical-college.html

4. US Library of Medicine. Changing the face of medicine: Dr. Margaret D. Craighill. Updated June 03, 2015. Accessed February 23, 2022. https://cfmedicine.nlm.nih.gov/physicians/biography_72.html

5. Knight AG. Dr. Margaret D. Craighill, M.D. On Point. 2018;23(4):19-22. Accessed February 24, 2022. https://www.jstor.org/stable/26478427.

6. Wamsley L. Pentagon releases new policies enabling transgender people to serve in the military. Updated March 31, 2021. Accessed February 23, 2022. https://www.npr.org/2021/03/31/983118029/pentagon-releases-new-policies-enabling-transgender-people-to-serve-in-the-milit

7. Shane L. Is VA shortchanging women’s health programs. Military Times. Published February 28, 2019. Accessed February 24, 2022. https://www.militarytimes.com/news/pentagon-congress/2019/02/28/is-va-spending-enough-on-womens-health-programs

8. Marshall V, Stryczek KC, Haverhals L, et al. The focus they deserve: improving women veterans’ health care access. Womens Health Issues. 2021;31(4):399-407. doi:10.1016/j.whi.2020.12.011

9. Craighill MD. Psychiatric aspects of women serving in the Army. Am J Psychiatry. 1947;104(4):226-230. doi:10.1176/ajp.104.4.226

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The Brain in COVID-19: No One Is Okay

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Knowing that I am a psychiatrist, my friends and colleagues recently started to ask me, “Am I losing my mind?” The symptoms underlying these concerned queries are remarkably similar: inability to concentrate, becoming easily frustrated, forgetting things, not being as productive as usual, being overly tired despite doing less, and feeling unusually irritable, among other vague somatic symptoms. This condition is to be distinguished from COVID-19 in the brain, which is the protean serious neuropsychiatric manifestations of infection with the virus ranging from strokes and seizures to encephalopathy and psychosis especially in severe cases of infection.1

As federal health care professionals (HCPs), many of us are familiar with acute high stress medical situations, which the pandemic has expanded and intensified: In New York City during the surge, the US Department of Veterans Affairs (VA) intensive care physician pushing life-sustaining resources to their limits in a valiant effort to keep alive as many people as possible; the US Public Health Service HCP working miracles without adequate supplies or staff in underserved hard-hit areas of the country; or the US Department of Defense clinician deftly trying to contain outbreaks in contained spaces like ships.

Emerging data already show that HCPs and other first responders facing these repeated episodes of acute stress are experiencing increased depression and anxiety.2 Research from prior pandemics suggests that this is only the beginning of a wave of negative mental health complications in HCPs.3

In the acute form of stress, the hypothalamic pituitary axis (HPA axis) is an evolutionary engine that coordinates multiple organ systems from lungs to liver to ensure efficient escape from primeval dinosaurs or more modern threats like viruses. Fueling that engine is the hormonal cascade that ends in excessive secretion of cortisol.

Chronic stress affects the body and brain in a different way than does acute stress. The problem is that this sympathetic nervous system surge is meant to power a sprint to survival not the marathon of uncertainty that COVID-19 has become. As long as the body stays in acute stress mode, the brain cannot downshift to the parasympathetic system that would usually moderate and regulate our neurobiologic circuits and neuropsychological processes. Like any other engine in overdrive, the stress gear erodes the machinery of our body and brain. Hence, the symptoms of psychophysical wear and tear—allostatic load—that most of us are experiencing.4

The subject of this column is the lower level of prolonged chronic stress. The mild and amorphous pertubations that can be described as “the brain in COVID-19.” It is a syndrome that affects even those who have never been infected with the actual virus. Though not usually life-threatening or disabling, it is unnerving and distressing as the queries from my colleagues and friends show. Their reports and my observations have led me to opine that “no one is okay” due to months of living under the strain of a pandemic.

The degree and scope of chronic stress that a person experiences caused by COVID-19 has to be contextualized and individualized. Those who have lost jobs, who are working while children are going to school online, who are caring for relatives, or who are in fear of losing their home face tremendous stress and challenges.5 Yet even those like me, whose biggest worry is a dog barking through important teleconference meetings, still undergo a milder form of near constant stress.

Consider that all of us have become strangers in an even stranger land. Masks have become an object of political controversy. In states where masking is mandatory, you must be mask vigilant every time you go out. In many areas of the country stores have limited hours, access, and supplies and any trip away from the house risks infection. Conversely, for those in a high-risk population, it may have been months since they have left home at all, and many sick, older, and vulnerable persons are suffering from isolation, loneliness, and boredom. The minor distractions and innocent pleasures that relieve day-to-day stress are no longer safe or available options, like eating out, attending shows, or taking trips.

Most of us are waiting for news of an effective available vaccine, some with yearning and others with dread. For George Gershwin, summertime meant that “the livin’ is easy,” but the summer of 2020 has been anything but easy and that takes its toll on the mind. Without adequate positive stimulation, attention wanders and memory fails to encode details, making even routine tasks more difficult; without meaningful social contact, emotions become sharp and ragged often hurting others. Most important, without periods in which we can relax, there is psychic exhaustion.6

At this point you may be thinking, “So, now that you told us we are all under chronic stress, are you going to tell us whether we can do anything about it?” There are many fantastic websites (including the VA) where experts far more qualified than I am offer excellent advice on coping with the pandemic.7 What I can provide is 5 reflections on managing the stress that I have used and that others with whom I shared them have found helpful.

1. Set realistic expectations. We are in a different reality in which we may need to take on smaller tasks, pace our work and take more breaks and, most of all, give ourselves a break when we are not as functional as we were before the pandemic.

2. Get out in nature. Find a green space to walk or sit, spend time with companion animals, go for a hike or bicycle near water or mountains, or watch the birds in a forest. Nothing can help restore our perspective or calm frayed nerves like the socially distanced outdoors.

3. Reach out. Even though we cannot hug or even shake hands, we can still pick up the phone or mouse and check on someone who is down. All the great traditions of the world agree that the best way to lift our own spirits is to help others.

4. Be kind. This is among the most important responses. As the epigraph suggests, everyone is engaged in an often silent and secret struggle and deserves our compassion. This call for kindness should be extended to ourselves so that we can be patient and compassionate to others.

5. Have courage and hope. This may be the most important of all. Whether we are infected or are fearing/avoiding infection, COVID-19 makes us sick in body and brain. We must have faith that there is something—the mind, the spirit—beyond the purely physical that gives us courage to outlast COVID-19 and to have hope for a postpandemic future that though not the same as before may well be in some ways better

References

1. Troyer EA, Kohn JN, Hong S. Are we facing a crashing wave of neuropsychiatric sequelae of COVID-19? Neuropsychiatric symptoms and potential immunologic mechanisms.  Brain Behav Immun . 2020;87:34-39. doi:10.1016/j.bbi.2020.04.027

2. Pappa S, Ntella V, Giannakas T, Giannakoulis VG, Papoutsi E, Katsaounou P. Prevalence of depression, anxiety, and insomnia among healthcare workers during the COVID-19pandemic: a systematic review and meta-analysis. Brain Behav Immun. 2020;88:901-907. doi:10.1016/j.bbi.2020.05.026

3. Salazar de Pablo G, Vaquerizo-Serrano J, Catalan A, et al. Impact of coronavirus syndromes on physical and mental health of health care workers: systematic review and meta-analysis.  J Affect Disord. 2020;275:48-57. doi:10.1016/j.jad.2020.06.022.

4. Harkness K. Strange physical symptoms? Blame the chronic stress of life during the Covid-19 pandemic. https://the-conversation.com/strange-physical-symptoms-blame-the-chronic-stress-of-life-during-the-covid-19-pandemic-139096. Published June 11, 2020. Accessed August 29, 2020.

5. Centers for Disease Control and Prevention. Coronavirus Disease (COVID-19) 2019. Coping with stress. https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/managing-stress-anxiety.html. Updated July 1, 2020. Accessed August 29, 2020.

6. Greenberg M. How the stress of the COVID-9 pandemic scrambles your brain. https://www.psychologytoday.com/us/blog/the-mindful-self-express/202006/how-the-stress-the-covid-19-pandemic-scrambles-your-brain. Published June 28, 2020. Accessed August 29, 2020.

7. US Department of Veterans Affairs, National Center for PTSD. Healthcare workers and responders. https://www.ptsd.va.gov/covid/list_healthcare_responders.asp. Updated August 12, 2020. Accessed August 29, 2020.

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Knowing that I am a psychiatrist, my friends and colleagues recently started to ask me, “Am I losing my mind?” The symptoms underlying these concerned queries are remarkably similar: inability to concentrate, becoming easily frustrated, forgetting things, not being as productive as usual, being overly tired despite doing less, and feeling unusually irritable, among other vague somatic symptoms. This condition is to be distinguished from COVID-19 in the brain, which is the protean serious neuropsychiatric manifestations of infection with the virus ranging from strokes and seizures to encephalopathy and psychosis especially in severe cases of infection.1

As federal health care professionals (HCPs), many of us are familiar with acute high stress medical situations, which the pandemic has expanded and intensified: In New York City during the surge, the US Department of Veterans Affairs (VA) intensive care physician pushing life-sustaining resources to their limits in a valiant effort to keep alive as many people as possible; the US Public Health Service HCP working miracles without adequate supplies or staff in underserved hard-hit areas of the country; or the US Department of Defense clinician deftly trying to contain outbreaks in contained spaces like ships.

Emerging data already show that HCPs and other first responders facing these repeated episodes of acute stress are experiencing increased depression and anxiety.2 Research from prior pandemics suggests that this is only the beginning of a wave of negative mental health complications in HCPs.3

In the acute form of stress, the hypothalamic pituitary axis (HPA axis) is an evolutionary engine that coordinates multiple organ systems from lungs to liver to ensure efficient escape from primeval dinosaurs or more modern threats like viruses. Fueling that engine is the hormonal cascade that ends in excessive secretion of cortisol.

Chronic stress affects the body and brain in a different way than does acute stress. The problem is that this sympathetic nervous system surge is meant to power a sprint to survival not the marathon of uncertainty that COVID-19 has become. As long as the body stays in acute stress mode, the brain cannot downshift to the parasympathetic system that would usually moderate and regulate our neurobiologic circuits and neuropsychological processes. Like any other engine in overdrive, the stress gear erodes the machinery of our body and brain. Hence, the symptoms of psychophysical wear and tear—allostatic load—that most of us are experiencing.4

The subject of this column is the lower level of prolonged chronic stress. The mild and amorphous pertubations that can be described as “the brain in COVID-19.” It is a syndrome that affects even those who have never been infected with the actual virus. Though not usually life-threatening or disabling, it is unnerving and distressing as the queries from my colleagues and friends show. Their reports and my observations have led me to opine that “no one is okay” due to months of living under the strain of a pandemic.

The degree and scope of chronic stress that a person experiences caused by COVID-19 has to be contextualized and individualized. Those who have lost jobs, who are working while children are going to school online, who are caring for relatives, or who are in fear of losing their home face tremendous stress and challenges.5 Yet even those like me, whose biggest worry is a dog barking through important teleconference meetings, still undergo a milder form of near constant stress.

Consider that all of us have become strangers in an even stranger land. Masks have become an object of political controversy. In states where masking is mandatory, you must be mask vigilant every time you go out. In many areas of the country stores have limited hours, access, and supplies and any trip away from the house risks infection. Conversely, for those in a high-risk population, it may have been months since they have left home at all, and many sick, older, and vulnerable persons are suffering from isolation, loneliness, and boredom. The minor distractions and innocent pleasures that relieve day-to-day stress are no longer safe or available options, like eating out, attending shows, or taking trips.

Most of us are waiting for news of an effective available vaccine, some with yearning and others with dread. For George Gershwin, summertime meant that “the livin’ is easy,” but the summer of 2020 has been anything but easy and that takes its toll on the mind. Without adequate positive stimulation, attention wanders and memory fails to encode details, making even routine tasks more difficult; without meaningful social contact, emotions become sharp and ragged often hurting others. Most important, without periods in which we can relax, there is psychic exhaustion.6

At this point you may be thinking, “So, now that you told us we are all under chronic stress, are you going to tell us whether we can do anything about it?” There are many fantastic websites (including the VA) where experts far more qualified than I am offer excellent advice on coping with the pandemic.7 What I can provide is 5 reflections on managing the stress that I have used and that others with whom I shared them have found helpful.

1. Set realistic expectations. We are in a different reality in which we may need to take on smaller tasks, pace our work and take more breaks and, most of all, give ourselves a break when we are not as functional as we were before the pandemic.

2. Get out in nature. Find a green space to walk or sit, spend time with companion animals, go for a hike or bicycle near water or mountains, or watch the birds in a forest. Nothing can help restore our perspective or calm frayed nerves like the socially distanced outdoors.

3. Reach out. Even though we cannot hug or even shake hands, we can still pick up the phone or mouse and check on someone who is down. All the great traditions of the world agree that the best way to lift our own spirits is to help others.

4. Be kind. This is among the most important responses. As the epigraph suggests, everyone is engaged in an often silent and secret struggle and deserves our compassion. This call for kindness should be extended to ourselves so that we can be patient and compassionate to others.

5. Have courage and hope. This may be the most important of all. Whether we are infected or are fearing/avoiding infection, COVID-19 makes us sick in body and brain. We must have faith that there is something—the mind, the spirit—beyond the purely physical that gives us courage to outlast COVID-19 and to have hope for a postpandemic future that though not the same as before may well be in some ways better

Knowing that I am a psychiatrist, my friends and colleagues recently started to ask me, “Am I losing my mind?” The symptoms underlying these concerned queries are remarkably similar: inability to concentrate, becoming easily frustrated, forgetting things, not being as productive as usual, being overly tired despite doing less, and feeling unusually irritable, among other vague somatic symptoms. This condition is to be distinguished from COVID-19 in the brain, which is the protean serious neuropsychiatric manifestations of infection with the virus ranging from strokes and seizures to encephalopathy and psychosis especially in severe cases of infection.1

As federal health care professionals (HCPs), many of us are familiar with acute high stress medical situations, which the pandemic has expanded and intensified: In New York City during the surge, the US Department of Veterans Affairs (VA) intensive care physician pushing life-sustaining resources to their limits in a valiant effort to keep alive as many people as possible; the US Public Health Service HCP working miracles without adequate supplies or staff in underserved hard-hit areas of the country; or the US Department of Defense clinician deftly trying to contain outbreaks in contained spaces like ships.

Emerging data already show that HCPs and other first responders facing these repeated episodes of acute stress are experiencing increased depression and anxiety.2 Research from prior pandemics suggests that this is only the beginning of a wave of negative mental health complications in HCPs.3

In the acute form of stress, the hypothalamic pituitary axis (HPA axis) is an evolutionary engine that coordinates multiple organ systems from lungs to liver to ensure efficient escape from primeval dinosaurs or more modern threats like viruses. Fueling that engine is the hormonal cascade that ends in excessive secretion of cortisol.

Chronic stress affects the body and brain in a different way than does acute stress. The problem is that this sympathetic nervous system surge is meant to power a sprint to survival not the marathon of uncertainty that COVID-19 has become. As long as the body stays in acute stress mode, the brain cannot downshift to the parasympathetic system that would usually moderate and regulate our neurobiologic circuits and neuropsychological processes. Like any other engine in overdrive, the stress gear erodes the machinery of our body and brain. Hence, the symptoms of psychophysical wear and tear—allostatic load—that most of us are experiencing.4

The subject of this column is the lower level of prolonged chronic stress. The mild and amorphous pertubations that can be described as “the brain in COVID-19.” It is a syndrome that affects even those who have never been infected with the actual virus. Though not usually life-threatening or disabling, it is unnerving and distressing as the queries from my colleagues and friends show. Their reports and my observations have led me to opine that “no one is okay” due to months of living under the strain of a pandemic.

The degree and scope of chronic stress that a person experiences caused by COVID-19 has to be contextualized and individualized. Those who have lost jobs, who are working while children are going to school online, who are caring for relatives, or who are in fear of losing their home face tremendous stress and challenges.5 Yet even those like me, whose biggest worry is a dog barking through important teleconference meetings, still undergo a milder form of near constant stress.

Consider that all of us have become strangers in an even stranger land. Masks have become an object of political controversy. In states where masking is mandatory, you must be mask vigilant every time you go out. In many areas of the country stores have limited hours, access, and supplies and any trip away from the house risks infection. Conversely, for those in a high-risk population, it may have been months since they have left home at all, and many sick, older, and vulnerable persons are suffering from isolation, loneliness, and boredom. The minor distractions and innocent pleasures that relieve day-to-day stress are no longer safe or available options, like eating out, attending shows, or taking trips.

Most of us are waiting for news of an effective available vaccine, some with yearning and others with dread. For George Gershwin, summertime meant that “the livin’ is easy,” but the summer of 2020 has been anything but easy and that takes its toll on the mind. Without adequate positive stimulation, attention wanders and memory fails to encode details, making even routine tasks more difficult; without meaningful social contact, emotions become sharp and ragged often hurting others. Most important, without periods in which we can relax, there is psychic exhaustion.6

At this point you may be thinking, “So, now that you told us we are all under chronic stress, are you going to tell us whether we can do anything about it?” There are many fantastic websites (including the VA) where experts far more qualified than I am offer excellent advice on coping with the pandemic.7 What I can provide is 5 reflections on managing the stress that I have used and that others with whom I shared them have found helpful.

1. Set realistic expectations. We are in a different reality in which we may need to take on smaller tasks, pace our work and take more breaks and, most of all, give ourselves a break when we are not as functional as we were before the pandemic.

2. Get out in nature. Find a green space to walk or sit, spend time with companion animals, go for a hike or bicycle near water or mountains, or watch the birds in a forest. Nothing can help restore our perspective or calm frayed nerves like the socially distanced outdoors.

3. Reach out. Even though we cannot hug or even shake hands, we can still pick up the phone or mouse and check on someone who is down. All the great traditions of the world agree that the best way to lift our own spirits is to help others.

4. Be kind. This is among the most important responses. As the epigraph suggests, everyone is engaged in an often silent and secret struggle and deserves our compassion. This call for kindness should be extended to ourselves so that we can be patient and compassionate to others.

5. Have courage and hope. This may be the most important of all. Whether we are infected or are fearing/avoiding infection, COVID-19 makes us sick in body and brain. We must have faith that there is something—the mind, the spirit—beyond the purely physical that gives us courage to outlast COVID-19 and to have hope for a postpandemic future that though not the same as before may well be in some ways better

References

1. Troyer EA, Kohn JN, Hong S. Are we facing a crashing wave of neuropsychiatric sequelae of COVID-19? Neuropsychiatric symptoms and potential immunologic mechanisms.  Brain Behav Immun . 2020;87:34-39. doi:10.1016/j.bbi.2020.04.027

2. Pappa S, Ntella V, Giannakas T, Giannakoulis VG, Papoutsi E, Katsaounou P. Prevalence of depression, anxiety, and insomnia among healthcare workers during the COVID-19pandemic: a systematic review and meta-analysis. Brain Behav Immun. 2020;88:901-907. doi:10.1016/j.bbi.2020.05.026

3. Salazar de Pablo G, Vaquerizo-Serrano J, Catalan A, et al. Impact of coronavirus syndromes on physical and mental health of health care workers: systematic review and meta-analysis.  J Affect Disord. 2020;275:48-57. doi:10.1016/j.jad.2020.06.022.

4. Harkness K. Strange physical symptoms? Blame the chronic stress of life during the Covid-19 pandemic. https://the-conversation.com/strange-physical-symptoms-blame-the-chronic-stress-of-life-during-the-covid-19-pandemic-139096. Published June 11, 2020. Accessed August 29, 2020.

5. Centers for Disease Control and Prevention. Coronavirus Disease (COVID-19) 2019. Coping with stress. https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/managing-stress-anxiety.html. Updated July 1, 2020. Accessed August 29, 2020.

6. Greenberg M. How the stress of the COVID-9 pandemic scrambles your brain. https://www.psychologytoday.com/us/blog/the-mindful-self-express/202006/how-the-stress-the-covid-19-pandemic-scrambles-your-brain. Published June 28, 2020. Accessed August 29, 2020.

7. US Department of Veterans Affairs, National Center for PTSD. Healthcare workers and responders. https://www.ptsd.va.gov/covid/list_healthcare_responders.asp. Updated August 12, 2020. Accessed August 29, 2020.

References

1. Troyer EA, Kohn JN, Hong S. Are we facing a crashing wave of neuropsychiatric sequelae of COVID-19? Neuropsychiatric symptoms and potential immunologic mechanisms.  Brain Behav Immun . 2020;87:34-39. doi:10.1016/j.bbi.2020.04.027

2. Pappa S, Ntella V, Giannakas T, Giannakoulis VG, Papoutsi E, Katsaounou P. Prevalence of depression, anxiety, and insomnia among healthcare workers during the COVID-19pandemic: a systematic review and meta-analysis. Brain Behav Immun. 2020;88:901-907. doi:10.1016/j.bbi.2020.05.026

3. Salazar de Pablo G, Vaquerizo-Serrano J, Catalan A, et al. Impact of coronavirus syndromes on physical and mental health of health care workers: systematic review and meta-analysis.  J Affect Disord. 2020;275:48-57. doi:10.1016/j.jad.2020.06.022.

4. Harkness K. Strange physical symptoms? Blame the chronic stress of life during the Covid-19 pandemic. https://the-conversation.com/strange-physical-symptoms-blame-the-chronic-stress-of-life-during-the-covid-19-pandemic-139096. Published June 11, 2020. Accessed August 29, 2020.

5. Centers for Disease Control and Prevention. Coronavirus Disease (COVID-19) 2019. Coping with stress. https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/managing-stress-anxiety.html. Updated July 1, 2020. Accessed August 29, 2020.

6. Greenberg M. How the stress of the COVID-9 pandemic scrambles your brain. https://www.psychologytoday.com/us/blog/the-mindful-self-express/202006/how-the-stress-the-covid-19-pandemic-scrambles-your-brain. Published June 28, 2020. Accessed August 29, 2020.

7. US Department of Veterans Affairs, National Center for PTSD. Healthcare workers and responders. https://www.ptsd.va.gov/covid/list_healthcare_responders.asp. Updated August 12, 2020. Accessed August 29, 2020.

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Providing free and open access to its high-quality peer-reviewed articles has always been important to Federal Practitioner, but finding them hasn’t always been easy for our readers and researchers. That has now changed. The full text of all Federal Practitioner peer-reviewed articles, editorials, and columns published after December 2014 are now available through the National Library of Medicine (NLM) PubMed Central (PMC) index (https://www.ncbi.nlm.nih.gov/pmc/).

To be sure, Federal Practitioner has always made it easy for print and digital subscribers to find our articles. Print journal subscriptions have been—and will remain—free to the 35,000 subscribers. Furthermore, anyone can access articles online (http://mdedge.com/fedprac), in the Federal Practitioner app, or in our digital edition (http://www.fedprac-digital.com/).

However, until now access beyond our base of loyal readers has been limited. Inclusion in PMC provides a much broader audience for Federal Practitioner authors, because PMC is an integral part of the NLM MEDLINE/PubMed database of 28 million biomedical citations and abstracts from more than 5,000 journals. All PMC articles appear in PubMed searches. On a typical day, about 2.5 million users in the US access PubMed to perform about 3 million searches and access 9 million page views.1

Inclusion also means that Federal Practitioner has passed a rigorous scientific and technical review of its content. Being included in PMC is a recognition of the quality of scholarship the journal publishes and a pledge of our continuing commitment to the highest quality of clinical education and research. Young investigators, clinician-educators, midcareer professionals, and others seeking to launch or enhance an academic career may want to consider or reconsider Federal Practitioner as the destination for manuscript submission.

One of the goals of this journal has been to provide a forum for federal health care providers (HCPs) to discuss and share with other federal colleagues. Federal HCPs from the Military Health System (MHS), Veterans Health Administration (VHA), and Indian Health Service (IHS) have addressed questions in Federal Practitioner that might not be explored elsewhere. Yet something important was missing from those conversations—engagement with the larger public health community. PubMed and PMC enable an ongoing conversation among health care researchers and providers. These are the places where researchers go to understand and respond to the questions that shape their research and clinical care. Now, Federal Practitioner authors can contribute more fully in ongoing debates.

As large integrated health care systems, the VHA, MHS, and IHS confront and address key public health care policy issues. Whether it’s the responsible and safe prescribing of opioids, the resource allocation decisions regarding the treatment of hepatitis C, or addressing suicide risk, the experience of federal HCPs must be a part of the public health debate. Moreover, many Federal Practitioner articles focus not just on preliminary research, but on the practical aspects of implementing patient-centered care. All US HCPs may benefit from hearing about federal providers challenges and success in providing patient-centered care.

Making available the complete text of all the articles furthers the Federal Practitioner mission: to educate federal HCPs and provide a forum for sharing health-care related studies, best practices, guidelines, program profiles, and case studies. We are excited to provide even more benefits for publication in Federal Practitioner. This journal welcomes submissions from new authors, well-traveled scholars, and everyone in between. Come on, join the conversation.

References

1. Fiorini N, Lipman DJ, Lu Z. Towards PubMed 2.0. eLife. 2017;6:e28801.

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Providing free and open access to its high-quality peer-reviewed articles has always been important to Federal Practitioner, but finding them hasn’t always been easy for our readers and researchers. That has now changed. The full text of all Federal Practitioner peer-reviewed articles, editorials, and columns published after December 2014 are now available through the National Library of Medicine (NLM) PubMed Central (PMC) index (https://www.ncbi.nlm.nih.gov/pmc/).

To be sure, Federal Practitioner has always made it easy for print and digital subscribers to find our articles. Print journal subscriptions have been—and will remain—free to the 35,000 subscribers. Furthermore, anyone can access articles online (http://mdedge.com/fedprac), in the Federal Practitioner app, or in our digital edition (http://www.fedprac-digital.com/).

However, until now access beyond our base of loyal readers has been limited. Inclusion in PMC provides a much broader audience for Federal Practitioner authors, because PMC is an integral part of the NLM MEDLINE/PubMed database of 28 million biomedical citations and abstracts from more than 5,000 journals. All PMC articles appear in PubMed searches. On a typical day, about 2.5 million users in the US access PubMed to perform about 3 million searches and access 9 million page views.1

Inclusion also means that Federal Practitioner has passed a rigorous scientific and technical review of its content. Being included in PMC is a recognition of the quality of scholarship the journal publishes and a pledge of our continuing commitment to the highest quality of clinical education and research. Young investigators, clinician-educators, midcareer professionals, and others seeking to launch or enhance an academic career may want to consider or reconsider Federal Practitioner as the destination for manuscript submission.

One of the goals of this journal has been to provide a forum for federal health care providers (HCPs) to discuss and share with other federal colleagues. Federal HCPs from the Military Health System (MHS), Veterans Health Administration (VHA), and Indian Health Service (IHS) have addressed questions in Federal Practitioner that might not be explored elsewhere. Yet something important was missing from those conversations—engagement with the larger public health community. PubMed and PMC enable an ongoing conversation among health care researchers and providers. These are the places where researchers go to understand and respond to the questions that shape their research and clinical care. Now, Federal Practitioner authors can contribute more fully in ongoing debates.

As large integrated health care systems, the VHA, MHS, and IHS confront and address key public health care policy issues. Whether it’s the responsible and safe prescribing of opioids, the resource allocation decisions regarding the treatment of hepatitis C, or addressing suicide risk, the experience of federal HCPs must be a part of the public health debate. Moreover, many Federal Practitioner articles focus not just on preliminary research, but on the practical aspects of implementing patient-centered care. All US HCPs may benefit from hearing about federal providers challenges and success in providing patient-centered care.

Making available the complete text of all the articles furthers the Federal Practitioner mission: to educate federal HCPs and provide a forum for sharing health-care related studies, best practices, guidelines, program profiles, and case studies. We are excited to provide even more benefits for publication in Federal Practitioner. This journal welcomes submissions from new authors, well-traveled scholars, and everyone in between. Come on, join the conversation.

Providing free and open access to its high-quality peer-reviewed articles has always been important to Federal Practitioner, but finding them hasn’t always been easy for our readers and researchers. That has now changed. The full text of all Federal Practitioner peer-reviewed articles, editorials, and columns published after December 2014 are now available through the National Library of Medicine (NLM) PubMed Central (PMC) index (https://www.ncbi.nlm.nih.gov/pmc/).

To be sure, Federal Practitioner has always made it easy for print and digital subscribers to find our articles. Print journal subscriptions have been—and will remain—free to the 35,000 subscribers. Furthermore, anyone can access articles online (http://mdedge.com/fedprac), in the Federal Practitioner app, or in our digital edition (http://www.fedprac-digital.com/).

However, until now access beyond our base of loyal readers has been limited. Inclusion in PMC provides a much broader audience for Federal Practitioner authors, because PMC is an integral part of the NLM MEDLINE/PubMed database of 28 million biomedical citations and abstracts from more than 5,000 journals. All PMC articles appear in PubMed searches. On a typical day, about 2.5 million users in the US access PubMed to perform about 3 million searches and access 9 million page views.1

Inclusion also means that Federal Practitioner has passed a rigorous scientific and technical review of its content. Being included in PMC is a recognition of the quality of scholarship the journal publishes and a pledge of our continuing commitment to the highest quality of clinical education and research. Young investigators, clinician-educators, midcareer professionals, and others seeking to launch or enhance an academic career may want to consider or reconsider Federal Practitioner as the destination for manuscript submission.

One of the goals of this journal has been to provide a forum for federal health care providers (HCPs) to discuss and share with other federal colleagues. Federal HCPs from the Military Health System (MHS), Veterans Health Administration (VHA), and Indian Health Service (IHS) have addressed questions in Federal Practitioner that might not be explored elsewhere. Yet something important was missing from those conversations—engagement with the larger public health community. PubMed and PMC enable an ongoing conversation among health care researchers and providers. These are the places where researchers go to understand and respond to the questions that shape their research and clinical care. Now, Federal Practitioner authors can contribute more fully in ongoing debates.

As large integrated health care systems, the VHA, MHS, and IHS confront and address key public health care policy issues. Whether it’s the responsible and safe prescribing of opioids, the resource allocation decisions regarding the treatment of hepatitis C, or addressing suicide risk, the experience of federal HCPs must be a part of the public health debate. Moreover, many Federal Practitioner articles focus not just on preliminary research, but on the practical aspects of implementing patient-centered care. All US HCPs may benefit from hearing about federal providers challenges and success in providing patient-centered care.

Making available the complete text of all the articles furthers the Federal Practitioner mission: to educate federal HCPs and provide a forum for sharing health-care related studies, best practices, guidelines, program profiles, and case studies. We are excited to provide even more benefits for publication in Federal Practitioner. This journal welcomes submissions from new authors, well-traveled scholars, and everyone in between. Come on, join the conversation.

References

1. Fiorini N, Lipman DJ, Lu Z. Towards PubMed 2.0. eLife. 2017;6:e28801.

References

1. Fiorini N, Lipman DJ, Lu Z. Towards PubMed 2.0. eLife. 2017;6:e28801.

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