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Medicine’s ‘Big Lie’
While today “The Big Lie” mainly refers to the actions of the prior President, an older and bigger lie that has a real effect on every American is one perpetrated by our very own health care conglomerate. Americans pay the highest rates for health care on the planet; health care consumes about 17% of our gross domestic product.1 If we got higher-quality care, faster services, longer lives, or even greater consumer happiness, paying those rates might be worth it. But we don’t.
Worse yet is the idea that “board certification” assures the public that the doctor from whom they receive/purchase care is of a higher quality than one who is not so credentialed. That is our “Big Lie!” For decades, the public has been told that they should seek out board-certified doctors. Doctors in training have been told they must get board-certified. Hospitals brag about employing only board-certified doctors, insurers sometimes mandate board certification for a doctor to get paid, and employers use board certification as a benchmark for hiring and as a factor in compensation.
The sacred secret is that board certification makes no difference. There is no substantial evidence in any branch of medicine that doctors who are board-certified are better. There is no evidence that board-certified doctors get their patients healthier with more frequency, faster, less expensively, or with fewer medical errors than other doctors. The reality is that board certification is a sham. It’s a certificate granted after taking a very expensive test, and it is now part of an industry that is misleading the public and harming the trust the medical profession had once earned. Board certification is the equivalent of a diploma mill or an online certificate in any other field.
Why has this been kept under wraps for so long? Follow the money. The American Board of Medical Specialties (ABMS) oversees 24 specialty boards and reported revenue of $22.2M and expenses of $19.3M on its 2019 IRS Form 990.2 They make profit every year. But, looking further, these “not-for-profit” educational entities are sitting on hundreds of millions of dollars in their “foundations.” Take the American Board of Psychiatry and Neurology, for instance. They had more than $140M in assets in 2019.3 How is this possible? Easy. They have misled the American public and been remarkably successful convincing other organizations, such as the Joint Commission, the Accreditation Council for Graduate Medical Education, and the National Committee for Quality Assurance, that board certification is an assurance of quality. They charge high fees to “candidates” for taking the computer-based test and have developed a system called maintenance of certification (MOC) that is onerous, expensive, and serves as an annuity that forces doctors to pay annually to keep their board certification.
Medicine is a science. In the practice of our discipline, we are expected to follow the science and to adhere to scientific principles. Yet there is neither scientific proof nor good evidence that board certification means anything in terms of competence, safety to the public, or quality of care. Doctors favor life-long learning, and continuing education has long been the standard and should remain so, not board certification or MOC. The mandatory continuing education required in every state to maintain a medical license is sufficient to prove doctors are current in their field of practice and to protect the public.
It is time for the medical community to admit that the emperor wears no clothes, and demand that the money grab of the ABMS and its affiliates be halted. This would result in greater access to care for patients and would reduce the cost of medical care, as the hundreds of millions being “stolen” from doctors today—costs that get passed on to patients—could be recouped and used for treating patients who clearly are in need and are being forgotten as the medical-industrial complex continues to flex its muscles and ensnare more of our national budget in its tentacles.
Neil S. Kaye, MD, DLFAPA
Hockessin, Delaware
1. The World Bank. Current health expenditure (% of GDP). Accessed July 12, 2021. https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS
2. American Board of Medical Specialties. 2019 Form 990. Return of Organization Exempt From Income Tax. Accessed July 12, 2021. https://www.abms.org/wp-content/uploads/2021/01/2019-american-board-of-medical-specialties-form-990.pdf
3. ProPublica. American Board of Psychiatry and Neurology. Accessed July 13, 2021. https://projects.propublica.org/nonprofits/organizations/410654864
While today “The Big Lie” mainly refers to the actions of the prior President, an older and bigger lie that has a real effect on every American is one perpetrated by our very own health care conglomerate. Americans pay the highest rates for health care on the planet; health care consumes about 17% of our gross domestic product.1 If we got higher-quality care, faster services, longer lives, or even greater consumer happiness, paying those rates might be worth it. But we don’t.
Worse yet is the idea that “board certification” assures the public that the doctor from whom they receive/purchase care is of a higher quality than one who is not so credentialed. That is our “Big Lie!” For decades, the public has been told that they should seek out board-certified doctors. Doctors in training have been told they must get board-certified. Hospitals brag about employing only board-certified doctors, insurers sometimes mandate board certification for a doctor to get paid, and employers use board certification as a benchmark for hiring and as a factor in compensation.
The sacred secret is that board certification makes no difference. There is no substantial evidence in any branch of medicine that doctors who are board-certified are better. There is no evidence that board-certified doctors get their patients healthier with more frequency, faster, less expensively, or with fewer medical errors than other doctors. The reality is that board certification is a sham. It’s a certificate granted after taking a very expensive test, and it is now part of an industry that is misleading the public and harming the trust the medical profession had once earned. Board certification is the equivalent of a diploma mill or an online certificate in any other field.
Why has this been kept under wraps for so long? Follow the money. The American Board of Medical Specialties (ABMS) oversees 24 specialty boards and reported revenue of $22.2M and expenses of $19.3M on its 2019 IRS Form 990.2 They make profit every year. But, looking further, these “not-for-profit” educational entities are sitting on hundreds of millions of dollars in their “foundations.” Take the American Board of Psychiatry and Neurology, for instance. They had more than $140M in assets in 2019.3 How is this possible? Easy. They have misled the American public and been remarkably successful convincing other organizations, such as the Joint Commission, the Accreditation Council for Graduate Medical Education, and the National Committee for Quality Assurance, that board certification is an assurance of quality. They charge high fees to “candidates” for taking the computer-based test and have developed a system called maintenance of certification (MOC) that is onerous, expensive, and serves as an annuity that forces doctors to pay annually to keep their board certification.
Medicine is a science. In the practice of our discipline, we are expected to follow the science and to adhere to scientific principles. Yet there is neither scientific proof nor good evidence that board certification means anything in terms of competence, safety to the public, or quality of care. Doctors favor life-long learning, and continuing education has long been the standard and should remain so, not board certification or MOC. The mandatory continuing education required in every state to maintain a medical license is sufficient to prove doctors are current in their field of practice and to protect the public.
It is time for the medical community to admit that the emperor wears no clothes, and demand that the money grab of the ABMS and its affiliates be halted. This would result in greater access to care for patients and would reduce the cost of medical care, as the hundreds of millions being “stolen” from doctors today—costs that get passed on to patients—could be recouped and used for treating patients who clearly are in need and are being forgotten as the medical-industrial complex continues to flex its muscles and ensnare more of our national budget in its tentacles.
Neil S. Kaye, MD, DLFAPA
Hockessin, Delaware
While today “The Big Lie” mainly refers to the actions of the prior President, an older and bigger lie that has a real effect on every American is one perpetrated by our very own health care conglomerate. Americans pay the highest rates for health care on the planet; health care consumes about 17% of our gross domestic product.1 If we got higher-quality care, faster services, longer lives, or even greater consumer happiness, paying those rates might be worth it. But we don’t.
Worse yet is the idea that “board certification” assures the public that the doctor from whom they receive/purchase care is of a higher quality than one who is not so credentialed. That is our “Big Lie!” For decades, the public has been told that they should seek out board-certified doctors. Doctors in training have been told they must get board-certified. Hospitals brag about employing only board-certified doctors, insurers sometimes mandate board certification for a doctor to get paid, and employers use board certification as a benchmark for hiring and as a factor in compensation.
The sacred secret is that board certification makes no difference. There is no substantial evidence in any branch of medicine that doctors who are board-certified are better. There is no evidence that board-certified doctors get their patients healthier with more frequency, faster, less expensively, or with fewer medical errors than other doctors. The reality is that board certification is a sham. It’s a certificate granted after taking a very expensive test, and it is now part of an industry that is misleading the public and harming the trust the medical profession had once earned. Board certification is the equivalent of a diploma mill or an online certificate in any other field.
Why has this been kept under wraps for so long? Follow the money. The American Board of Medical Specialties (ABMS) oversees 24 specialty boards and reported revenue of $22.2M and expenses of $19.3M on its 2019 IRS Form 990.2 They make profit every year. But, looking further, these “not-for-profit” educational entities are sitting on hundreds of millions of dollars in their “foundations.” Take the American Board of Psychiatry and Neurology, for instance. They had more than $140M in assets in 2019.3 How is this possible? Easy. They have misled the American public and been remarkably successful convincing other organizations, such as the Joint Commission, the Accreditation Council for Graduate Medical Education, and the National Committee for Quality Assurance, that board certification is an assurance of quality. They charge high fees to “candidates” for taking the computer-based test and have developed a system called maintenance of certification (MOC) that is onerous, expensive, and serves as an annuity that forces doctors to pay annually to keep their board certification.
Medicine is a science. In the practice of our discipline, we are expected to follow the science and to adhere to scientific principles. Yet there is neither scientific proof nor good evidence that board certification means anything in terms of competence, safety to the public, or quality of care. Doctors favor life-long learning, and continuing education has long been the standard and should remain so, not board certification or MOC. The mandatory continuing education required in every state to maintain a medical license is sufficient to prove doctors are current in their field of practice and to protect the public.
It is time for the medical community to admit that the emperor wears no clothes, and demand that the money grab of the ABMS and its affiliates be halted. This would result in greater access to care for patients and would reduce the cost of medical care, as the hundreds of millions being “stolen” from doctors today—costs that get passed on to patients—could be recouped and used for treating patients who clearly are in need and are being forgotten as the medical-industrial complex continues to flex its muscles and ensnare more of our national budget in its tentacles.
Neil S. Kaye, MD, DLFAPA
Hockessin, Delaware
1. The World Bank. Current health expenditure (% of GDP). Accessed July 12, 2021. https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS
2. American Board of Medical Specialties. 2019 Form 990. Return of Organization Exempt From Income Tax. Accessed July 12, 2021. https://www.abms.org/wp-content/uploads/2021/01/2019-american-board-of-medical-specialties-form-990.pdf
3. ProPublica. American Board of Psychiatry and Neurology. Accessed July 13, 2021. https://projects.propublica.org/nonprofits/organizations/410654864
1. The World Bank. Current health expenditure (% of GDP). Accessed July 12, 2021. https://data.worldbank.org/indicator/SH.XPD.CHEX.GD.ZS
2. American Board of Medical Specialties. 2019 Form 990. Return of Organization Exempt From Income Tax. Accessed July 12, 2021. https://www.abms.org/wp-content/uploads/2021/01/2019-american-board-of-medical-specialties-form-990.pdf
3. ProPublica. American Board of Psychiatry and Neurology. Accessed July 13, 2021. https://projects.propublica.org/nonprofits/organizations/410654864
My palliative care rotation: Lessons of gratitude, mindfulness, and kindness
As a psychiatry resident and as a part of consultation-liaison service, I have visited many palliative care patients to assist other physicians in managing psychiatric issues such as depression, anxiety, or delirium. But recently, as the first resident from our Department of Psychiatry who was sent to a palliative care rotation, I followed these patients as a part of a primary palliative care team. Doing so allowed me to see patients from the other side of the bridge.
Palliative care focuses on providing relief from the suffering and stress of a patient’s illness, with the primary goal of improving the quality of life of the patient and their families. The palliative care team works in collaboration with the patient’s other clinicians to provide an extra layer of support. They provide biopsychosociocultural interventions that are in harmony with the needs of the patient rather than the prognosis of the illness. To do so, they first must evaluate the needs of the patient and their family. This is a time-consuming, energy-consuming, emotionally draining job.
During my palliative care rotation, I attended table rounds, bedside rounds, family meetings, long counseling sessions, and disposition planning meetings. This rotation also gave me the opportunity to place my feet in the shoes of a palliative care team and to reflect on how it feels to be the physician of a patient who is dying, which as a psychiatric resident I had seldom experienced. I learned that although working with patients who are dying can cause stress, burnout, and compassion fatigue, it also helps physicians appreciate the little things in life. To appreciate all the blessings we have that we usually take for granted. To practice gratitude. To be kind.
Upon reflection, I learned that the rounds of palliative care are actually mindfulness-based discussions that provide cushions of supportive work, facilitate feelings of being in control, tend to alleviate physical as well as mental suffering, foster clear-sighted hope, and assist in establishing small, subjectively significant, realistic goals for the patient’s immediate future, and to help the patient achieve these goals.
A valuable lesson from a patient
I want to highlight a case of a 65-year-old woman I first visited while I was shadowing my attending, who had been providing palliative care to the patient and her family for several months. The patient was admitted to a tertiary care hospital because cancer had invaded her small bowel and caused mechanical obstruction, resulting in intractable vomiting, abdominal distension, and anorexia. She underwent open laparotomy and ileostomy for symptomatic relief. A nasogastric tube was placed, and she was put on total parenteral nutrition. The day I met her was her third postoperative day. She had been improving significantly, and she wanted to eat. She was missing food. Most of the discussion in the round among my attending, the patient, and her family was centered around how to get to the point where she would be able to eat again and appreciate the taste of biryani.
What my attending did was incredible. After assessing the patient’s needs, he instilled a realistic hope: the hope of tasting food again. The attending, while acknowledging the patient’s apprehensions, respectfully and supportively kept her from wandering into the future, made every possible attempt to bring her attention back to the present moment, and helped her establish goals for the present and her immediate future. My attending was not toxic-positive, forcing his patient to uselessly revisit her current trauma. Instead, he was kind, empathic, and considerate. His primary focus was to understand rather than to be understood, to help her find meaning, and to improve her quality of life—a quality she defined for herself, which was to taste the food of her choice.
That day, when I returned to my working station in the psychiatry ward and had lunch in the break room, I thought, “When I eat, how often do I think about eating?” Mostly I either think about work, tasks, and presentations, or I scroll on social media.
Our taste buds indeed get adapted to repetitive stimulation, but the experience of eating our favorite dish is the naked truth of being alive, and is something that I have been taking for granted for a long time. These are little things in life that I need to appreciate, and learn to cultivate their power.
As a psychiatry resident and as a part of consultation-liaison service, I have visited many palliative care patients to assist other physicians in managing psychiatric issues such as depression, anxiety, or delirium. But recently, as the first resident from our Department of Psychiatry who was sent to a palliative care rotation, I followed these patients as a part of a primary palliative care team. Doing so allowed me to see patients from the other side of the bridge.
Palliative care focuses on providing relief from the suffering and stress of a patient’s illness, with the primary goal of improving the quality of life of the patient and their families. The palliative care team works in collaboration with the patient’s other clinicians to provide an extra layer of support. They provide biopsychosociocultural interventions that are in harmony with the needs of the patient rather than the prognosis of the illness. To do so, they first must evaluate the needs of the patient and their family. This is a time-consuming, energy-consuming, emotionally draining job.
During my palliative care rotation, I attended table rounds, bedside rounds, family meetings, long counseling sessions, and disposition planning meetings. This rotation also gave me the opportunity to place my feet in the shoes of a palliative care team and to reflect on how it feels to be the physician of a patient who is dying, which as a psychiatric resident I had seldom experienced. I learned that although working with patients who are dying can cause stress, burnout, and compassion fatigue, it also helps physicians appreciate the little things in life. To appreciate all the blessings we have that we usually take for granted. To practice gratitude. To be kind.
Upon reflection, I learned that the rounds of palliative care are actually mindfulness-based discussions that provide cushions of supportive work, facilitate feelings of being in control, tend to alleviate physical as well as mental suffering, foster clear-sighted hope, and assist in establishing small, subjectively significant, realistic goals for the patient’s immediate future, and to help the patient achieve these goals.
A valuable lesson from a patient
I want to highlight a case of a 65-year-old woman I first visited while I was shadowing my attending, who had been providing palliative care to the patient and her family for several months. The patient was admitted to a tertiary care hospital because cancer had invaded her small bowel and caused mechanical obstruction, resulting in intractable vomiting, abdominal distension, and anorexia. She underwent open laparotomy and ileostomy for symptomatic relief. A nasogastric tube was placed, and she was put on total parenteral nutrition. The day I met her was her third postoperative day. She had been improving significantly, and she wanted to eat. She was missing food. Most of the discussion in the round among my attending, the patient, and her family was centered around how to get to the point where she would be able to eat again and appreciate the taste of biryani.
What my attending did was incredible. After assessing the patient’s needs, he instilled a realistic hope: the hope of tasting food again. The attending, while acknowledging the patient’s apprehensions, respectfully and supportively kept her from wandering into the future, made every possible attempt to bring her attention back to the present moment, and helped her establish goals for the present and her immediate future. My attending was not toxic-positive, forcing his patient to uselessly revisit her current trauma. Instead, he was kind, empathic, and considerate. His primary focus was to understand rather than to be understood, to help her find meaning, and to improve her quality of life—a quality she defined for herself, which was to taste the food of her choice.
That day, when I returned to my working station in the psychiatry ward and had lunch in the break room, I thought, “When I eat, how often do I think about eating?” Mostly I either think about work, tasks, and presentations, or I scroll on social media.
Our taste buds indeed get adapted to repetitive stimulation, but the experience of eating our favorite dish is the naked truth of being alive, and is something that I have been taking for granted for a long time. These are little things in life that I need to appreciate, and learn to cultivate their power.
As a psychiatry resident and as a part of consultation-liaison service, I have visited many palliative care patients to assist other physicians in managing psychiatric issues such as depression, anxiety, or delirium. But recently, as the first resident from our Department of Psychiatry who was sent to a palliative care rotation, I followed these patients as a part of a primary palliative care team. Doing so allowed me to see patients from the other side of the bridge.
Palliative care focuses on providing relief from the suffering and stress of a patient’s illness, with the primary goal of improving the quality of life of the patient and their families. The palliative care team works in collaboration with the patient’s other clinicians to provide an extra layer of support. They provide biopsychosociocultural interventions that are in harmony with the needs of the patient rather than the prognosis of the illness. To do so, they first must evaluate the needs of the patient and their family. This is a time-consuming, energy-consuming, emotionally draining job.
During my palliative care rotation, I attended table rounds, bedside rounds, family meetings, long counseling sessions, and disposition planning meetings. This rotation also gave me the opportunity to place my feet in the shoes of a palliative care team and to reflect on how it feels to be the physician of a patient who is dying, which as a psychiatric resident I had seldom experienced. I learned that although working with patients who are dying can cause stress, burnout, and compassion fatigue, it also helps physicians appreciate the little things in life. To appreciate all the blessings we have that we usually take for granted. To practice gratitude. To be kind.
Upon reflection, I learned that the rounds of palliative care are actually mindfulness-based discussions that provide cushions of supportive work, facilitate feelings of being in control, tend to alleviate physical as well as mental suffering, foster clear-sighted hope, and assist in establishing small, subjectively significant, realistic goals for the patient’s immediate future, and to help the patient achieve these goals.
A valuable lesson from a patient
I want to highlight a case of a 65-year-old woman I first visited while I was shadowing my attending, who had been providing palliative care to the patient and her family for several months. The patient was admitted to a tertiary care hospital because cancer had invaded her small bowel and caused mechanical obstruction, resulting in intractable vomiting, abdominal distension, and anorexia. She underwent open laparotomy and ileostomy for symptomatic relief. A nasogastric tube was placed, and she was put on total parenteral nutrition. The day I met her was her third postoperative day. She had been improving significantly, and she wanted to eat. She was missing food. Most of the discussion in the round among my attending, the patient, and her family was centered around how to get to the point where she would be able to eat again and appreciate the taste of biryani.
What my attending did was incredible. After assessing the patient’s needs, he instilled a realistic hope: the hope of tasting food again. The attending, while acknowledging the patient’s apprehensions, respectfully and supportively kept her from wandering into the future, made every possible attempt to bring her attention back to the present moment, and helped her establish goals for the present and her immediate future. My attending was not toxic-positive, forcing his patient to uselessly revisit her current trauma. Instead, he was kind, empathic, and considerate. His primary focus was to understand rather than to be understood, to help her find meaning, and to improve her quality of life—a quality she defined for herself, which was to taste the food of her choice.
That day, when I returned to my working station in the psychiatry ward and had lunch in the break room, I thought, “When I eat, how often do I think about eating?” Mostly I either think about work, tasks, and presentations, or I scroll on social media.
Our taste buds indeed get adapted to repetitive stimulation, but the experience of eating our favorite dish is the naked truth of being alive, and is something that I have been taking for granted for a long time. These are little things in life that I need to appreciate, and learn to cultivate their power.
Introduction: Precision Oncology Changes the Game for VA Health Care (FULL)
For US Army veteran Tam Huynh, the US Department of Veterans Affairs (VA) precision oncology program has been the proverbial game changer. Diagnosed in 2016 with stage IV lung cancer and physically depleted by chemotherapy, Huynh learned that treatment based on the precise molecular makeup of his tumors held the potential for improving quality of life. Through the VA National Precision Oncology Program (NPOP), Huynh was matched to a medication shown to help patients whose tumors had the same genetic mutation as Huynh’s tumors. Today, Huynh is not only free of chemotherapy’s debilitating adverse effects, but able to enjoy time with his family and return to work.
Huynh is one of 400,000 veterans treated for cancer annually at the VA. The life-changing treatment he received is due to the legacy of research, integrated care, and collaboration that is the hallmark of the VA health care system. The NPOP is a natural outgrowth of this legacy, and, as Executive-in-Charge Richard Stone, MD, notes in his Foreword, part of the Veterans Health Administration’s (VHA) evolution as a learning health care system. The articles in this special issue represent a snapshot of the work underway under VHA NPOP as well as the dedication of VHA staff nationwide to provide patient-centric care to every veteran.
Leading off this special issue, NPOP director Michael J. Kelley, MD, provides context for understanding the paradigm shift represented by precision oncology.2 He also discusses how, within 5 years, the program came together from its start as a regional effort to its use today by almost every VA oncology practice. Kelley also explains the complexity behind interpreting next-generation sequencing (NGS) gene panel test results and how VA medical centers can call upon NPOP for assistance with this interpretation. Further, he states the “obligation” for new medical technology to be accessible and notes how NPOP was “intentional” during implementation to ensure rural veterans would be offered testing.2
Following Kelley’s discussion is a series of articles focused on precision oncology for prostate cancer, which affects 15,000 veterans yearly. The first, an overview of the Prostate Cancer Foundation (PCF), provides a short history of the organization and how it came to partner with the VA.3 Written by several PCF staff, including President and CEO Jonathan Simons, MD, the paper notes how the commitment of early leaders like S. Ward Casscells, MD, and Larry Stupski led to PCF’s “no veteran left behind” philosophy; ie, ensuring veteran access to clinical trials and world class care regardless of location. As the first disease-specific national network for oncology trials serving veterans, PCF aims to provide a model for all of US health care in the delivery of precision oncology care.
A critical part of PCF is the Precision Oncology Program for Cancer of the Prostate (POPCaP), which focuses on genetics and genomic testing. Bruce Montgomery, MD, and Matthew Retting, MD—VHA’s leading experts in prostate cancer—shine the spotlight on VA’s research track record, specifically the genomics of metastatic prostate cancer.4 They also note the program’s focus on African American veteran patients who are disproportionately affected by the disease but well represented in the VA. In discussing future directions, the authors explain the importance of expanding genetic testing for those diagnosed with prostate cancer.
Prostate cancer Analysis for Therapy Choice (PATCH) is a clinical trials network that works hand-in-hand with POPCaP to use genetic data collected by POPCaP sites to find patients for trials. In their discussion, authors Julie N. Graff, MD, and Grant D. Huang, MD, who leads VA Research’s Cooperative Studies Program, focus on 3 key areas: (1) the challenges of precision oncology when working with relatively rare mutations; (2) 2 new drug trials at VA that will help clinicians know whether certain targeted therapies work for prostate cancer; and (3) how VA is emerging as a national partner in drug discovery and the approval of precision drugs.5
Turning to lung cancer–the second leading cause of cancer death among veterans–Drew Moghanaki, MD, MPH, and Michael Hagan, MD, discuss 3 multisite initiatives launched in 2016 and 2017.6 The first trial, VA Partnership to Increase Access to Lung Cancer Screening (VA-PALS), is a multisite project sponsored by the VA’s Office of Rural Health and Bristol-Myers Squibb Foundation. The trial’s goal is to reduce lung cancer mortality through a robust early detection program. The second trial, VA Lung Cancer Surgery OR Radiation therapy (VALOR) compares whether radiation or surgery is the best for early-stage lung cancer. Notably, VALOR may be one of the most difficult randomized trial ever attempted in lung cancer research (4 previous phase 3 trials outside the VA closed prematurely). By addressing the previous challenges associated with running such a trial, the VALOR study team already has enrolled more than all of the previous phase 3 efforts combined. The third trial is VA Radiation Oncology Quality Surveillance Program (VA-ROQS), which was created in 2016 to benchmark the treatment of veterans with lung cancer. VA-ROQS aims to create a national network of Lung Cancer Centers of Excellence that work with VISNs to ensure that treatment decisions for veterans with lung cancer are based on all available molecular information.
The final group of authors, led by Maren T. Scheuner, MD, discuss how the advent of germline testing as a standard-of-care practice for certain tumor types presents opportunities and challenges for precision oncology.7 One of the primary challenges they note is the shortage of genetics professionals, both within the VA system and health care generally. To help address this issue, they recommend leveraging VA’s longstanding partnership with its academic affiliates.
Precision oncology clearly demonstrates how applying knowledge regarding one of the smallest of living matter can make a tremendous difference in the matter of living. Tam Huynh’s story is proof positive. Speaking at last year’s AMSUS (Society for Federal Health Professionals) annual meeting about his experience, Huynh said that all veterans should have access to the same life-changing treatment he received. This is exactly where the VA NPOP is heading.
1. How the VA is using AI to target cancer, https://www.theatlantic.com/sponsored/ibm-2018/watson-va-cancer/1925. Accessed August 6, 2020.
2. Kelley MJ. VA National Precision Oncology Program. Fed Pract. 2020;37 (suppl 4):S22-S27. doi:10.12788/fp.0037
3. Levine RD, Ekanayake RN, Martin AC, et al. Prostate Cancer Foundation-Department of Veterans Affairs partnership: a model of public-private collaboration to advance treatment and care of invasive cancers. Fed Pract. 2020;37(suppl 4):S32-S37. doi: 10.12788/fp.0035
4. Montgomery B, Rettig M, Kasten J, Muralidhar S, Myrie K, Ramoni R. The Precision Oncology Program for Cancer of the Prostate (POPCaP) network: a Veterans Affairs/Prostate Cancer Foundation collaboration. Fed Pract. 2020;37(suppl 4):S48-S53. doi:10.12788/fp.0021
5. Graff JN, Huang GD. Leveraging Veterans Health Administration clinical and research resources to accelerate discovery and testing in precision oncology. Fed Pract. 2020;37(suppl 4):S62-S67. doi:10.12788/fp.0028
6. Moghanaki D, Hagan M. Strategic initiatives for veterans with lung cancer. Fed Pract. 2020;37(suppl 4):S76-S80. doi:10.12788/fp.0019
7. Scheuner MT, Myrie K, Peredo J, et al. Integrating germline genetics into precision oncology practice in the Veterans Health Administration: challenges and opportunities. Fed Pract. 2020;37(suppl 4):S82-S88. doi:10.12788/fp.0033
For US Army veteran Tam Huynh, the US Department of Veterans Affairs (VA) precision oncology program has been the proverbial game changer. Diagnosed in 2016 with stage IV lung cancer and physically depleted by chemotherapy, Huynh learned that treatment based on the precise molecular makeup of his tumors held the potential for improving quality of life. Through the VA National Precision Oncology Program (NPOP), Huynh was matched to a medication shown to help patients whose tumors had the same genetic mutation as Huynh’s tumors. Today, Huynh is not only free of chemotherapy’s debilitating adverse effects, but able to enjoy time with his family and return to work.
Huynh is one of 400,000 veterans treated for cancer annually at the VA. The life-changing treatment he received is due to the legacy of research, integrated care, and collaboration that is the hallmark of the VA health care system. The NPOP is a natural outgrowth of this legacy, and, as Executive-in-Charge Richard Stone, MD, notes in his Foreword, part of the Veterans Health Administration’s (VHA) evolution as a learning health care system. The articles in this special issue represent a snapshot of the work underway under VHA NPOP as well as the dedication of VHA staff nationwide to provide patient-centric care to every veteran.
Leading off this special issue, NPOP director Michael J. Kelley, MD, provides context for understanding the paradigm shift represented by precision oncology.2 He also discusses how, within 5 years, the program came together from its start as a regional effort to its use today by almost every VA oncology practice. Kelley also explains the complexity behind interpreting next-generation sequencing (NGS) gene panel test results and how VA medical centers can call upon NPOP for assistance with this interpretation. Further, he states the “obligation” for new medical technology to be accessible and notes how NPOP was “intentional” during implementation to ensure rural veterans would be offered testing.2
Following Kelley’s discussion is a series of articles focused on precision oncology for prostate cancer, which affects 15,000 veterans yearly. The first, an overview of the Prostate Cancer Foundation (PCF), provides a short history of the organization and how it came to partner with the VA.3 Written by several PCF staff, including President and CEO Jonathan Simons, MD, the paper notes how the commitment of early leaders like S. Ward Casscells, MD, and Larry Stupski led to PCF’s “no veteran left behind” philosophy; ie, ensuring veteran access to clinical trials and world class care regardless of location. As the first disease-specific national network for oncology trials serving veterans, PCF aims to provide a model for all of US health care in the delivery of precision oncology care.
A critical part of PCF is the Precision Oncology Program for Cancer of the Prostate (POPCaP), which focuses on genetics and genomic testing. Bruce Montgomery, MD, and Matthew Retting, MD—VHA’s leading experts in prostate cancer—shine the spotlight on VA’s research track record, specifically the genomics of metastatic prostate cancer.4 They also note the program’s focus on African American veteran patients who are disproportionately affected by the disease but well represented in the VA. In discussing future directions, the authors explain the importance of expanding genetic testing for those diagnosed with prostate cancer.
Prostate cancer Analysis for Therapy Choice (PATCH) is a clinical trials network that works hand-in-hand with POPCaP to use genetic data collected by POPCaP sites to find patients for trials. In their discussion, authors Julie N. Graff, MD, and Grant D. Huang, MD, who leads VA Research’s Cooperative Studies Program, focus on 3 key areas: (1) the challenges of precision oncology when working with relatively rare mutations; (2) 2 new drug trials at VA that will help clinicians know whether certain targeted therapies work for prostate cancer; and (3) how VA is emerging as a national partner in drug discovery and the approval of precision drugs.5
Turning to lung cancer–the second leading cause of cancer death among veterans–Drew Moghanaki, MD, MPH, and Michael Hagan, MD, discuss 3 multisite initiatives launched in 2016 and 2017.6 The first trial, VA Partnership to Increase Access to Lung Cancer Screening (VA-PALS), is a multisite project sponsored by the VA’s Office of Rural Health and Bristol-Myers Squibb Foundation. The trial’s goal is to reduce lung cancer mortality through a robust early detection program. The second trial, VA Lung Cancer Surgery OR Radiation therapy (VALOR) compares whether radiation or surgery is the best for early-stage lung cancer. Notably, VALOR may be one of the most difficult randomized trial ever attempted in lung cancer research (4 previous phase 3 trials outside the VA closed prematurely). By addressing the previous challenges associated with running such a trial, the VALOR study team already has enrolled more than all of the previous phase 3 efforts combined. The third trial is VA Radiation Oncology Quality Surveillance Program (VA-ROQS), which was created in 2016 to benchmark the treatment of veterans with lung cancer. VA-ROQS aims to create a national network of Lung Cancer Centers of Excellence that work with VISNs to ensure that treatment decisions for veterans with lung cancer are based on all available molecular information.
The final group of authors, led by Maren T. Scheuner, MD, discuss how the advent of germline testing as a standard-of-care practice for certain tumor types presents opportunities and challenges for precision oncology.7 One of the primary challenges they note is the shortage of genetics professionals, both within the VA system and health care generally. To help address this issue, they recommend leveraging VA’s longstanding partnership with its academic affiliates.
Precision oncology clearly demonstrates how applying knowledge regarding one of the smallest of living matter can make a tremendous difference in the matter of living. Tam Huynh’s story is proof positive. Speaking at last year’s AMSUS (Society for Federal Health Professionals) annual meeting about his experience, Huynh said that all veterans should have access to the same life-changing treatment he received. This is exactly where the VA NPOP is heading.
For US Army veteran Tam Huynh, the US Department of Veterans Affairs (VA) precision oncology program has been the proverbial game changer. Diagnosed in 2016 with stage IV lung cancer and physically depleted by chemotherapy, Huynh learned that treatment based on the precise molecular makeup of his tumors held the potential for improving quality of life. Through the VA National Precision Oncology Program (NPOP), Huynh was matched to a medication shown to help patients whose tumors had the same genetic mutation as Huynh’s tumors. Today, Huynh is not only free of chemotherapy’s debilitating adverse effects, but able to enjoy time with his family and return to work.
Huynh is one of 400,000 veterans treated for cancer annually at the VA. The life-changing treatment he received is due to the legacy of research, integrated care, and collaboration that is the hallmark of the VA health care system. The NPOP is a natural outgrowth of this legacy, and, as Executive-in-Charge Richard Stone, MD, notes in his Foreword, part of the Veterans Health Administration’s (VHA) evolution as a learning health care system. The articles in this special issue represent a snapshot of the work underway under VHA NPOP as well as the dedication of VHA staff nationwide to provide patient-centric care to every veteran.
Leading off this special issue, NPOP director Michael J. Kelley, MD, provides context for understanding the paradigm shift represented by precision oncology.2 He also discusses how, within 5 years, the program came together from its start as a regional effort to its use today by almost every VA oncology practice. Kelley also explains the complexity behind interpreting next-generation sequencing (NGS) gene panel test results and how VA medical centers can call upon NPOP for assistance with this interpretation. Further, he states the “obligation” for new medical technology to be accessible and notes how NPOP was “intentional” during implementation to ensure rural veterans would be offered testing.2
Following Kelley’s discussion is a series of articles focused on precision oncology for prostate cancer, which affects 15,000 veterans yearly. The first, an overview of the Prostate Cancer Foundation (PCF), provides a short history of the organization and how it came to partner with the VA.3 Written by several PCF staff, including President and CEO Jonathan Simons, MD, the paper notes how the commitment of early leaders like S. Ward Casscells, MD, and Larry Stupski led to PCF’s “no veteran left behind” philosophy; ie, ensuring veteran access to clinical trials and world class care regardless of location. As the first disease-specific national network for oncology trials serving veterans, PCF aims to provide a model for all of US health care in the delivery of precision oncology care.
A critical part of PCF is the Precision Oncology Program for Cancer of the Prostate (POPCaP), which focuses on genetics and genomic testing. Bruce Montgomery, MD, and Matthew Retting, MD—VHA’s leading experts in prostate cancer—shine the spotlight on VA’s research track record, specifically the genomics of metastatic prostate cancer.4 They also note the program’s focus on African American veteran patients who are disproportionately affected by the disease but well represented in the VA. In discussing future directions, the authors explain the importance of expanding genetic testing for those diagnosed with prostate cancer.
Prostate cancer Analysis for Therapy Choice (PATCH) is a clinical trials network that works hand-in-hand with POPCaP to use genetic data collected by POPCaP sites to find patients for trials. In their discussion, authors Julie N. Graff, MD, and Grant D. Huang, MD, who leads VA Research’s Cooperative Studies Program, focus on 3 key areas: (1) the challenges of precision oncology when working with relatively rare mutations; (2) 2 new drug trials at VA that will help clinicians know whether certain targeted therapies work for prostate cancer; and (3) how VA is emerging as a national partner in drug discovery and the approval of precision drugs.5
Turning to lung cancer–the second leading cause of cancer death among veterans–Drew Moghanaki, MD, MPH, and Michael Hagan, MD, discuss 3 multisite initiatives launched in 2016 and 2017.6 The first trial, VA Partnership to Increase Access to Lung Cancer Screening (VA-PALS), is a multisite project sponsored by the VA’s Office of Rural Health and Bristol-Myers Squibb Foundation. The trial’s goal is to reduce lung cancer mortality through a robust early detection program. The second trial, VA Lung Cancer Surgery OR Radiation therapy (VALOR) compares whether radiation or surgery is the best for early-stage lung cancer. Notably, VALOR may be one of the most difficult randomized trial ever attempted in lung cancer research (4 previous phase 3 trials outside the VA closed prematurely). By addressing the previous challenges associated with running such a trial, the VALOR study team already has enrolled more than all of the previous phase 3 efforts combined. The third trial is VA Radiation Oncology Quality Surveillance Program (VA-ROQS), which was created in 2016 to benchmark the treatment of veterans with lung cancer. VA-ROQS aims to create a national network of Lung Cancer Centers of Excellence that work with VISNs to ensure that treatment decisions for veterans with lung cancer are based on all available molecular information.
The final group of authors, led by Maren T. Scheuner, MD, discuss how the advent of germline testing as a standard-of-care practice for certain tumor types presents opportunities and challenges for precision oncology.7 One of the primary challenges they note is the shortage of genetics professionals, both within the VA system and health care generally. To help address this issue, they recommend leveraging VA’s longstanding partnership with its academic affiliates.
Precision oncology clearly demonstrates how applying knowledge regarding one of the smallest of living matter can make a tremendous difference in the matter of living. Tam Huynh’s story is proof positive. Speaking at last year’s AMSUS (Society for Federal Health Professionals) annual meeting about his experience, Huynh said that all veterans should have access to the same life-changing treatment he received. This is exactly where the VA NPOP is heading.
1. How the VA is using AI to target cancer, https://www.theatlantic.com/sponsored/ibm-2018/watson-va-cancer/1925. Accessed August 6, 2020.
2. Kelley MJ. VA National Precision Oncology Program. Fed Pract. 2020;37 (suppl 4):S22-S27. doi:10.12788/fp.0037
3. Levine RD, Ekanayake RN, Martin AC, et al. Prostate Cancer Foundation-Department of Veterans Affairs partnership: a model of public-private collaboration to advance treatment and care of invasive cancers. Fed Pract. 2020;37(suppl 4):S32-S37. doi: 10.12788/fp.0035
4. Montgomery B, Rettig M, Kasten J, Muralidhar S, Myrie K, Ramoni R. The Precision Oncology Program for Cancer of the Prostate (POPCaP) network: a Veterans Affairs/Prostate Cancer Foundation collaboration. Fed Pract. 2020;37(suppl 4):S48-S53. doi:10.12788/fp.0021
5. Graff JN, Huang GD. Leveraging Veterans Health Administration clinical and research resources to accelerate discovery and testing in precision oncology. Fed Pract. 2020;37(suppl 4):S62-S67. doi:10.12788/fp.0028
6. Moghanaki D, Hagan M. Strategic initiatives for veterans with lung cancer. Fed Pract. 2020;37(suppl 4):S76-S80. doi:10.12788/fp.0019
7. Scheuner MT, Myrie K, Peredo J, et al. Integrating germline genetics into precision oncology practice in the Veterans Health Administration: challenges and opportunities. Fed Pract. 2020;37(suppl 4):S82-S88. doi:10.12788/fp.0033
1. How the VA is using AI to target cancer, https://www.theatlantic.com/sponsored/ibm-2018/watson-va-cancer/1925. Accessed August 6, 2020.
2. Kelley MJ. VA National Precision Oncology Program. Fed Pract. 2020;37 (suppl 4):S22-S27. doi:10.12788/fp.0037
3. Levine RD, Ekanayake RN, Martin AC, et al. Prostate Cancer Foundation-Department of Veterans Affairs partnership: a model of public-private collaboration to advance treatment and care of invasive cancers. Fed Pract. 2020;37(suppl 4):S32-S37. doi: 10.12788/fp.0035
4. Montgomery B, Rettig M, Kasten J, Muralidhar S, Myrie K, Ramoni R. The Precision Oncology Program for Cancer of the Prostate (POPCaP) network: a Veterans Affairs/Prostate Cancer Foundation collaboration. Fed Pract. 2020;37(suppl 4):S48-S53. doi:10.12788/fp.0021
5. Graff JN, Huang GD. Leveraging Veterans Health Administration clinical and research resources to accelerate discovery and testing in precision oncology. Fed Pract. 2020;37(suppl 4):S62-S67. doi:10.12788/fp.0028
6. Moghanaki D, Hagan M. Strategic initiatives for veterans with lung cancer. Fed Pract. 2020;37(suppl 4):S76-S80. doi:10.12788/fp.0019
7. Scheuner MT, Myrie K, Peredo J, et al. Integrating germline genetics into precision oncology practice in the Veterans Health Administration: challenges and opportunities. Fed Pract. 2020;37(suppl 4):S82-S88. doi:10.12788/fp.0033
Advances in Precision Oncology: Foreword (FULL)
For > 90 years, the US Department of Veterans Affairs (VA) has been in the vanguard of cancer research and treatment—improving the lives of veterans and all Americans. In 1932, recognizing the intrinsic link between research and clinical care, the Edward Hines, Jr. VA Hospital in Chicago, Illinois, established a tumor research laboratory to complement the work of its cancer treatment center. As the first VA laboratory to receive funding specifically for research, the new facility symbolized a paradigm shift in thinking about cancer treatment.
Today, through its National Precision Oncology Program (NPOP), the Veterans Health Administration (VHA) has embarked upon another paradigm shift—one that also puts research front and center by leveraging VHA’s unique assets as a learning health care system. As noted by Montgomery and colleagues, “given its size, integration and capabilities, the VA is an ideal setting for rapid learning cycles of testing and implementing best practices at scale.”1 The articles in this special issue, which focus on the 2 cancers that affects the most veterans—prostate and lung—show the transformative work underway to develop a new model of collaboration in cancer care.
At VHA, research and practice are not just proximal; they are truly integrated in the service of enhancing veterans’ outcomes. For example, > 60% of VA researchers are clinicians who also provide direct patient care. As observed by Levine and colleagues, “meaningful advances in cancer care depend on both laboratory and clinical research. This combination, known as translational research, takes discoveries in the laboratory and applies them to patients and vice versa.”2
For example, it was physician-scientist Donald Gleason, MD, PhD, who in the 1960s pioneered the standardized system that helps doctors better assess and treat prostate cancer (the Gleason score). More recently, physician-scientists Matthew Rettig, MD, and Bruce Montgomery, MD, both leading experts in prostate cancer research, were instrumental to VA’s partnership with the Prostate Cancer Foundation (PCF) to establish a national network for oncology trials serving veterans.
Having an embedded research program within the nation’s largest integrated health care system also provides the VA with the ability to conduct large-scale, multisite clinical trials. Since the 1940s, the VA Cooperative Studies Program (CSP) has generated key research findings across a range of diseases, including cancer, and provided definitive evidence and learning. In 1994, CSP launched its Prostate Cancer Intervention vs Observation Trial (PIVOT) study to determine whether observation is as effective as surgery for early-stage prostate cancer. Today, through the CSP, VA researchers are conducting a randomized, phase 3 clinical trial called VA Lung cancer surgery Or stereotactic Radiotherapy trial (VALOR) that will assess which of the 2 modalities is better when treating veterans with operable early-stage non-small cell lung cancer.
Additionally, VA is privileged to serve a patient population so dedicated to their country that many volunteer to serve again as participants in VA research clinical trials. In fact, Levine and colleagues credit the patients willing to enter clinical trials for the collective call to action and “critical philanthropic investment” that led to the Precision Oncology Program for Cancer of the Prostate (POPCaP).2
As a learning health care system, we also have been mindful of lessons drawn from the ongoing COVID-19 public health crisis. Almost overnight, VHA shifted from in-person to virtual visits to minimize the risk for veterans and their families. At the same time, we limited in-person clinical research visits to those that were required for the Veterans’ health or well-being and conducted large numbers of virtual research visits. (Notably, the current crisis motivated accelerated study regarding virtual research trials, clarifying which touchpoints must be face-to-face and which have been face-to-face due mainly to convention.) In parallel, we also launched numerous clinical studies focused on the fight against COVID-19. Our capacity to transition both clinical care and research is due in no small part to our preexisting and strong foundation in telehealth.
With one-third of our patient population living in rural areas, these achievements are vital to our commitment of “no veteran left behind.” These efforts were recently boosted by VHA’s newest partnership with the Bristol Myers Squibb Foundation to establish a national teleoncology center that will enable all veterans to benefit from new research advances no matter where they live.
Precision oncology represents a new model of collaboration in cancer care among clinicians, operations leaders, researchers and veterans. By leveraging the many assets that have contributed to VA’s success as a learning health care system, we can fulfill the promise of providing leading edge cancer care to all veterans.
1. Montgomery B, Rettig M, Kasten J, Muralidhar S, Myrie K, Ramoni R. The Precision Oncology Program for Cancer of the Prostate (POPCaP) network: a Veterans Affairs/Prostate Cancer Foundation collaboration. Fed Pract. 2020;37(suppl 4):S48-S53. doi:10.12788/fp.0021
2. Levine RD, Ekanayake RN, Martin AC, et al. Prostate Cancer Foundation-Department of Veterans Affairs Partnership: a model of public-private collaboration to advance treatment and care of invasive cancers. Fed Pract. 2020;37(suppl 4):S32-S37. doi:10.12788/fp.0035
For > 90 years, the US Department of Veterans Affairs (VA) has been in the vanguard of cancer research and treatment—improving the lives of veterans and all Americans. In 1932, recognizing the intrinsic link between research and clinical care, the Edward Hines, Jr. VA Hospital in Chicago, Illinois, established a tumor research laboratory to complement the work of its cancer treatment center. As the first VA laboratory to receive funding specifically for research, the new facility symbolized a paradigm shift in thinking about cancer treatment.
Today, through its National Precision Oncology Program (NPOP), the Veterans Health Administration (VHA) has embarked upon another paradigm shift—one that also puts research front and center by leveraging VHA’s unique assets as a learning health care system. As noted by Montgomery and colleagues, “given its size, integration and capabilities, the VA is an ideal setting for rapid learning cycles of testing and implementing best practices at scale.”1 The articles in this special issue, which focus on the 2 cancers that affects the most veterans—prostate and lung—show the transformative work underway to develop a new model of collaboration in cancer care.
At VHA, research and practice are not just proximal; they are truly integrated in the service of enhancing veterans’ outcomes. For example, > 60% of VA researchers are clinicians who also provide direct patient care. As observed by Levine and colleagues, “meaningful advances in cancer care depend on both laboratory and clinical research. This combination, known as translational research, takes discoveries in the laboratory and applies them to patients and vice versa.”2
For example, it was physician-scientist Donald Gleason, MD, PhD, who in the 1960s pioneered the standardized system that helps doctors better assess and treat prostate cancer (the Gleason score). More recently, physician-scientists Matthew Rettig, MD, and Bruce Montgomery, MD, both leading experts in prostate cancer research, were instrumental to VA’s partnership with the Prostate Cancer Foundation (PCF) to establish a national network for oncology trials serving veterans.
Having an embedded research program within the nation’s largest integrated health care system also provides the VA with the ability to conduct large-scale, multisite clinical trials. Since the 1940s, the VA Cooperative Studies Program (CSP) has generated key research findings across a range of diseases, including cancer, and provided definitive evidence and learning. In 1994, CSP launched its Prostate Cancer Intervention vs Observation Trial (PIVOT) study to determine whether observation is as effective as surgery for early-stage prostate cancer. Today, through the CSP, VA researchers are conducting a randomized, phase 3 clinical trial called VA Lung cancer surgery Or stereotactic Radiotherapy trial (VALOR) that will assess which of the 2 modalities is better when treating veterans with operable early-stage non-small cell lung cancer.
Additionally, VA is privileged to serve a patient population so dedicated to their country that many volunteer to serve again as participants in VA research clinical trials. In fact, Levine and colleagues credit the patients willing to enter clinical trials for the collective call to action and “critical philanthropic investment” that led to the Precision Oncology Program for Cancer of the Prostate (POPCaP).2
As a learning health care system, we also have been mindful of lessons drawn from the ongoing COVID-19 public health crisis. Almost overnight, VHA shifted from in-person to virtual visits to minimize the risk for veterans and their families. At the same time, we limited in-person clinical research visits to those that were required for the Veterans’ health or well-being and conducted large numbers of virtual research visits. (Notably, the current crisis motivated accelerated study regarding virtual research trials, clarifying which touchpoints must be face-to-face and which have been face-to-face due mainly to convention.) In parallel, we also launched numerous clinical studies focused on the fight against COVID-19. Our capacity to transition both clinical care and research is due in no small part to our preexisting and strong foundation in telehealth.
With one-third of our patient population living in rural areas, these achievements are vital to our commitment of “no veteran left behind.” These efforts were recently boosted by VHA’s newest partnership with the Bristol Myers Squibb Foundation to establish a national teleoncology center that will enable all veterans to benefit from new research advances no matter where they live.
Precision oncology represents a new model of collaboration in cancer care among clinicians, operations leaders, researchers and veterans. By leveraging the many assets that have contributed to VA’s success as a learning health care system, we can fulfill the promise of providing leading edge cancer care to all veterans.
For > 90 years, the US Department of Veterans Affairs (VA) has been in the vanguard of cancer research and treatment—improving the lives of veterans and all Americans. In 1932, recognizing the intrinsic link between research and clinical care, the Edward Hines, Jr. VA Hospital in Chicago, Illinois, established a tumor research laboratory to complement the work of its cancer treatment center. As the first VA laboratory to receive funding specifically for research, the new facility symbolized a paradigm shift in thinking about cancer treatment.
Today, through its National Precision Oncology Program (NPOP), the Veterans Health Administration (VHA) has embarked upon another paradigm shift—one that also puts research front and center by leveraging VHA’s unique assets as a learning health care system. As noted by Montgomery and colleagues, “given its size, integration and capabilities, the VA is an ideal setting for rapid learning cycles of testing and implementing best practices at scale.”1 The articles in this special issue, which focus on the 2 cancers that affects the most veterans—prostate and lung—show the transformative work underway to develop a new model of collaboration in cancer care.
At VHA, research and practice are not just proximal; they are truly integrated in the service of enhancing veterans’ outcomes. For example, > 60% of VA researchers are clinicians who also provide direct patient care. As observed by Levine and colleagues, “meaningful advances in cancer care depend on both laboratory and clinical research. This combination, known as translational research, takes discoveries in the laboratory and applies them to patients and vice versa.”2
For example, it was physician-scientist Donald Gleason, MD, PhD, who in the 1960s pioneered the standardized system that helps doctors better assess and treat prostate cancer (the Gleason score). More recently, physician-scientists Matthew Rettig, MD, and Bruce Montgomery, MD, both leading experts in prostate cancer research, were instrumental to VA’s partnership with the Prostate Cancer Foundation (PCF) to establish a national network for oncology trials serving veterans.
Having an embedded research program within the nation’s largest integrated health care system also provides the VA with the ability to conduct large-scale, multisite clinical trials. Since the 1940s, the VA Cooperative Studies Program (CSP) has generated key research findings across a range of diseases, including cancer, and provided definitive evidence and learning. In 1994, CSP launched its Prostate Cancer Intervention vs Observation Trial (PIVOT) study to determine whether observation is as effective as surgery for early-stage prostate cancer. Today, through the CSP, VA researchers are conducting a randomized, phase 3 clinical trial called VA Lung cancer surgery Or stereotactic Radiotherapy trial (VALOR) that will assess which of the 2 modalities is better when treating veterans with operable early-stage non-small cell lung cancer.
Additionally, VA is privileged to serve a patient population so dedicated to their country that many volunteer to serve again as participants in VA research clinical trials. In fact, Levine and colleagues credit the patients willing to enter clinical trials for the collective call to action and “critical philanthropic investment” that led to the Precision Oncology Program for Cancer of the Prostate (POPCaP).2
As a learning health care system, we also have been mindful of lessons drawn from the ongoing COVID-19 public health crisis. Almost overnight, VHA shifted from in-person to virtual visits to minimize the risk for veterans and their families. At the same time, we limited in-person clinical research visits to those that were required for the Veterans’ health or well-being and conducted large numbers of virtual research visits. (Notably, the current crisis motivated accelerated study regarding virtual research trials, clarifying which touchpoints must be face-to-face and which have been face-to-face due mainly to convention.) In parallel, we also launched numerous clinical studies focused on the fight against COVID-19. Our capacity to transition both clinical care and research is due in no small part to our preexisting and strong foundation in telehealth.
With one-third of our patient population living in rural areas, these achievements are vital to our commitment of “no veteran left behind.” These efforts were recently boosted by VHA’s newest partnership with the Bristol Myers Squibb Foundation to establish a national teleoncology center that will enable all veterans to benefit from new research advances no matter where they live.
Precision oncology represents a new model of collaboration in cancer care among clinicians, operations leaders, researchers and veterans. By leveraging the many assets that have contributed to VA’s success as a learning health care system, we can fulfill the promise of providing leading edge cancer care to all veterans.
1. Montgomery B, Rettig M, Kasten J, Muralidhar S, Myrie K, Ramoni R. The Precision Oncology Program for Cancer of the Prostate (POPCaP) network: a Veterans Affairs/Prostate Cancer Foundation collaboration. Fed Pract. 2020;37(suppl 4):S48-S53. doi:10.12788/fp.0021
2. Levine RD, Ekanayake RN, Martin AC, et al. Prostate Cancer Foundation-Department of Veterans Affairs Partnership: a model of public-private collaboration to advance treatment and care of invasive cancers. Fed Pract. 2020;37(suppl 4):S32-S37. doi:10.12788/fp.0035
1. Montgomery B, Rettig M, Kasten J, Muralidhar S, Myrie K, Ramoni R. The Precision Oncology Program for Cancer of the Prostate (POPCaP) network: a Veterans Affairs/Prostate Cancer Foundation collaboration. Fed Pract. 2020;37(suppl 4):S48-S53. doi:10.12788/fp.0021
2. Levine RD, Ekanayake RN, Martin AC, et al. Prostate Cancer Foundation-Department of Veterans Affairs Partnership: a model of public-private collaboration to advance treatment and care of invasive cancers. Fed Pract. 2020;37(suppl 4):S32-S37. doi:10.12788/fp.0035
Catching up with ourselves
August is a month that we traditionally reserved for rest and recovery. But unfortunately, there seems to be little of either as we recover from COVID-19, deal with the care that has been delayed, try to understand issues of health inequity, and manage our hybrid reimbursement landscape. So let’s set those issues aside for a bit and get back to science.
In this month’s cover stories, we can read about some astounding accomplishments. A fantastic study comes from Dana-Farber Cancer Institute, Boston, where researchers found 900 colorectal cancers from nurses who had participated in the long-running Nurse’s Health Studies. The researchers completed a whole-exome sequence on both normal and tumor tissue and then linked findings to the nutritional information contained in the Health Studies. With this information, they connected a tumor-associated mutation to the ingestion of red meat, which may suggest a causal link for the known association between red meat and CRC.
AGA has published a detailed clinical practice update about endoscopic management of postsurgical complications after bariatric/metabolic surgery. Bariatric therapy is an area in which gastroenterologists should play an increasingly prominent role, in conjunction with our surgical and metabolic colleagues.
Finally, read about a novel oral therapy that may provide substantial relief for celiac patients. This randomized trial of a transglutaminase inhibitor was published in the New England Journal of Medicine and may provide new hope for this difficult condition.
October marks the end of my term as Editor-in-Chief. Megan Adams, MD, JD, MSc, will take over and provide insights and opinions beyond my past missives. I thank Christopher Palmer and the excellent Frontline staff who find topics and compose articles for us. Finally, the publication department at the American Gastroenterological Association is unparalleled, led by Erin Landis with Jillian Schweitzer managing the GI & Hepatology News area. I am fortunate to return to the AGA Governing Board as Secretary/Treasurer and work with our new president, John Inadomi, as well as Tom Serena, a great friend and AGA CEO.
John I Allen, MD, MBA, AGAF
Editor in Chief
August is a month that we traditionally reserved for rest and recovery. But unfortunately, there seems to be little of either as we recover from COVID-19, deal with the care that has been delayed, try to understand issues of health inequity, and manage our hybrid reimbursement landscape. So let’s set those issues aside for a bit and get back to science.
In this month’s cover stories, we can read about some astounding accomplishments. A fantastic study comes from Dana-Farber Cancer Institute, Boston, where researchers found 900 colorectal cancers from nurses who had participated in the long-running Nurse’s Health Studies. The researchers completed a whole-exome sequence on both normal and tumor tissue and then linked findings to the nutritional information contained in the Health Studies. With this information, they connected a tumor-associated mutation to the ingestion of red meat, which may suggest a causal link for the known association between red meat and CRC.
AGA has published a detailed clinical practice update about endoscopic management of postsurgical complications after bariatric/metabolic surgery. Bariatric therapy is an area in which gastroenterologists should play an increasingly prominent role, in conjunction with our surgical and metabolic colleagues.
Finally, read about a novel oral therapy that may provide substantial relief for celiac patients. This randomized trial of a transglutaminase inhibitor was published in the New England Journal of Medicine and may provide new hope for this difficult condition.
October marks the end of my term as Editor-in-Chief. Megan Adams, MD, JD, MSc, will take over and provide insights and opinions beyond my past missives. I thank Christopher Palmer and the excellent Frontline staff who find topics and compose articles for us. Finally, the publication department at the American Gastroenterological Association is unparalleled, led by Erin Landis with Jillian Schweitzer managing the GI & Hepatology News area. I am fortunate to return to the AGA Governing Board as Secretary/Treasurer and work with our new president, John Inadomi, as well as Tom Serena, a great friend and AGA CEO.
John I Allen, MD, MBA, AGAF
Editor in Chief
August is a month that we traditionally reserved for rest and recovery. But unfortunately, there seems to be little of either as we recover from COVID-19, deal with the care that has been delayed, try to understand issues of health inequity, and manage our hybrid reimbursement landscape. So let’s set those issues aside for a bit and get back to science.
In this month’s cover stories, we can read about some astounding accomplishments. A fantastic study comes from Dana-Farber Cancer Institute, Boston, where researchers found 900 colorectal cancers from nurses who had participated in the long-running Nurse’s Health Studies. The researchers completed a whole-exome sequence on both normal and tumor tissue and then linked findings to the nutritional information contained in the Health Studies. With this information, they connected a tumor-associated mutation to the ingestion of red meat, which may suggest a causal link for the known association between red meat and CRC.
AGA has published a detailed clinical practice update about endoscopic management of postsurgical complications after bariatric/metabolic surgery. Bariatric therapy is an area in which gastroenterologists should play an increasingly prominent role, in conjunction with our surgical and metabolic colleagues.
Finally, read about a novel oral therapy that may provide substantial relief for celiac patients. This randomized trial of a transglutaminase inhibitor was published in the New England Journal of Medicine and may provide new hope for this difficult condition.
October marks the end of my term as Editor-in-Chief. Megan Adams, MD, JD, MSc, will take over and provide insights and opinions beyond my past missives. I thank Christopher Palmer and the excellent Frontline staff who find topics and compose articles for us. Finally, the publication department at the American Gastroenterological Association is unparalleled, led by Erin Landis with Jillian Schweitzer managing the GI & Hepatology News area. I am fortunate to return to the AGA Governing Board as Secretary/Treasurer and work with our new president, John Inadomi, as well as Tom Serena, a great friend and AGA CEO.
John I Allen, MD, MBA, AGAF
Editor in Chief
COVID-19, hearings on Jan. 6 attack reignite interest in PTSD
After Sept. 11, 2001, and the subsequent long war in Iraq and Afghanistan, both mental health providers and the general public focused on posttraumatic stress disorder (PTSD). However, after almost 20 years of war and the COVID-19 epidemic, attention waned away from military service members and PTSD.
COVID-19–related PTSD and the hearings on the Jan. 6 attack on the Capitol have reignited interest in PTSD diagnosis and treatment. Testimony from police officers at the House select committee hearing about their experiences during the assault and PTSD was harrowing. One of the police officers had also served in Iraq, perhaps leading to “layered PTSD” – symptoms from war abroad and at home.
Thus, I thought a brief review of updates about diagnosis and treatment would be useful. Note: These are my opinions based on my extensive experience and do not represent the official opinion of my employer (MedStar Health).
PTSD was first classified as a disorder in 1980, based mainly on the experiences of military service members in Vietnam, as well as sexual assault victims and disaster survivors. Readers may look elsewhere for a fuller history of the disorder.
However, in brief, we have evolved from strict reliance on a variety of symptoms in the DSM (Diagnostic and Statistical Manual of Mental Disorders) to a more global determination of the experience of trauma and related symptoms of distress. We still rely for diagnosis on trauma-related anxiety and depression symptoms, such as nightmare, flashbacks, numbness, and disassociation.
Treatment has evolved. Patients may benefit from treatment even if they do not meet all the PTSD criteria. As many of my colleagues who treat patients have said, “if it smells like PTSD, treat it like PTSD.”
What is the most effective treatment? The literature declares that evidence-based treatments include two selective serotonin reuptake inhibitors (Zoloft and Paxil) and several psychotherapies. The psychotherapies include cognitive-behavioral therapies, exposure therapy, and EMDR (eye movement desensitization reprocessing).
The problem is that many patients cannot tolerate these therapies. SSRIs do have side effects, the most distressing being sexual dysfunction. Many service members do not enter the psychotherapies, or they drop out of trials, because they cannot tolerate the reimagining of their trauma.
I now counsel patients about the “three buckets” of treatment. The first bucket is medication, which as a psychiatrist is what I focus on. The second bucket is psychotherapy as discussed above. The third bucket is “everything else.”
“Everything else” includes a variety of methods the patients can use to reduce symptoms of anxiety, depression, and PTSD symptoms: exercising; deep breathing through the nose; doing yoga; doing meditation; playing or working with animals; gardening; and engaging in other activities that “self sooth.” I also recommend always doing “small acts of kindness” for others. I myself contribute to food banks and bring cookies or watermelons to the staff at my hospital.
Why is this approach useful? A menu of options gives control back to the patient. It provides activities that can reduce anxiety. Thinking about caring for others helps patients get out of their own “swamp of distress.”
We do live in very difficult times. We’re coping with COVID-19 Delta variant, attacks on the Capitol, and gun violence. I have not yet mentioned climate change, which is extremely frightening to many of us. So all providers need to be aware of all the strategies at our disposal to treat anxiety, depression, and PTSD.
Dr. Ritchie is chair of psychiatry at Medstar Washington (D.C.) Hospital Center. She has no conflicts of interest.
After Sept. 11, 2001, and the subsequent long war in Iraq and Afghanistan, both mental health providers and the general public focused on posttraumatic stress disorder (PTSD). However, after almost 20 years of war and the COVID-19 epidemic, attention waned away from military service members and PTSD.
COVID-19–related PTSD and the hearings on the Jan. 6 attack on the Capitol have reignited interest in PTSD diagnosis and treatment. Testimony from police officers at the House select committee hearing about their experiences during the assault and PTSD was harrowing. One of the police officers had also served in Iraq, perhaps leading to “layered PTSD” – symptoms from war abroad and at home.
Thus, I thought a brief review of updates about diagnosis and treatment would be useful. Note: These are my opinions based on my extensive experience and do not represent the official opinion of my employer (MedStar Health).
PTSD was first classified as a disorder in 1980, based mainly on the experiences of military service members in Vietnam, as well as sexual assault victims and disaster survivors. Readers may look elsewhere for a fuller history of the disorder.
However, in brief, we have evolved from strict reliance on a variety of symptoms in the DSM (Diagnostic and Statistical Manual of Mental Disorders) to a more global determination of the experience of trauma and related symptoms of distress. We still rely for diagnosis on trauma-related anxiety and depression symptoms, such as nightmare, flashbacks, numbness, and disassociation.
Treatment has evolved. Patients may benefit from treatment even if they do not meet all the PTSD criteria. As many of my colleagues who treat patients have said, “if it smells like PTSD, treat it like PTSD.”
What is the most effective treatment? The literature declares that evidence-based treatments include two selective serotonin reuptake inhibitors (Zoloft and Paxil) and several psychotherapies. The psychotherapies include cognitive-behavioral therapies, exposure therapy, and EMDR (eye movement desensitization reprocessing).
The problem is that many patients cannot tolerate these therapies. SSRIs do have side effects, the most distressing being sexual dysfunction. Many service members do not enter the psychotherapies, or they drop out of trials, because they cannot tolerate the reimagining of their trauma.
I now counsel patients about the “three buckets” of treatment. The first bucket is medication, which as a psychiatrist is what I focus on. The second bucket is psychotherapy as discussed above. The third bucket is “everything else.”
“Everything else” includes a variety of methods the patients can use to reduce symptoms of anxiety, depression, and PTSD symptoms: exercising; deep breathing through the nose; doing yoga; doing meditation; playing or working with animals; gardening; and engaging in other activities that “self sooth.” I also recommend always doing “small acts of kindness” for others. I myself contribute to food banks and bring cookies or watermelons to the staff at my hospital.
Why is this approach useful? A menu of options gives control back to the patient. It provides activities that can reduce anxiety. Thinking about caring for others helps patients get out of their own “swamp of distress.”
We do live in very difficult times. We’re coping with COVID-19 Delta variant, attacks on the Capitol, and gun violence. I have not yet mentioned climate change, which is extremely frightening to many of us. So all providers need to be aware of all the strategies at our disposal to treat anxiety, depression, and PTSD.
Dr. Ritchie is chair of psychiatry at Medstar Washington (D.C.) Hospital Center. She has no conflicts of interest.
After Sept. 11, 2001, and the subsequent long war in Iraq and Afghanistan, both mental health providers and the general public focused on posttraumatic stress disorder (PTSD). However, after almost 20 years of war and the COVID-19 epidemic, attention waned away from military service members and PTSD.
COVID-19–related PTSD and the hearings on the Jan. 6 attack on the Capitol have reignited interest in PTSD diagnosis and treatment. Testimony from police officers at the House select committee hearing about their experiences during the assault and PTSD was harrowing. One of the police officers had also served in Iraq, perhaps leading to “layered PTSD” – symptoms from war abroad and at home.
Thus, I thought a brief review of updates about diagnosis and treatment would be useful. Note: These are my opinions based on my extensive experience and do not represent the official opinion of my employer (MedStar Health).
PTSD was first classified as a disorder in 1980, based mainly on the experiences of military service members in Vietnam, as well as sexual assault victims and disaster survivors. Readers may look elsewhere for a fuller history of the disorder.
However, in brief, we have evolved from strict reliance on a variety of symptoms in the DSM (Diagnostic and Statistical Manual of Mental Disorders) to a more global determination of the experience of trauma and related symptoms of distress. We still rely for diagnosis on trauma-related anxiety and depression symptoms, such as nightmare, flashbacks, numbness, and disassociation.
Treatment has evolved. Patients may benefit from treatment even if they do not meet all the PTSD criteria. As many of my colleagues who treat patients have said, “if it smells like PTSD, treat it like PTSD.”
What is the most effective treatment? The literature declares that evidence-based treatments include two selective serotonin reuptake inhibitors (Zoloft and Paxil) and several psychotherapies. The psychotherapies include cognitive-behavioral therapies, exposure therapy, and EMDR (eye movement desensitization reprocessing).
The problem is that many patients cannot tolerate these therapies. SSRIs do have side effects, the most distressing being sexual dysfunction. Many service members do not enter the psychotherapies, or they drop out of trials, because they cannot tolerate the reimagining of their trauma.
I now counsel patients about the “three buckets” of treatment. The first bucket is medication, which as a psychiatrist is what I focus on. The second bucket is psychotherapy as discussed above. The third bucket is “everything else.”
“Everything else” includes a variety of methods the patients can use to reduce symptoms of anxiety, depression, and PTSD symptoms: exercising; deep breathing through the nose; doing yoga; doing meditation; playing or working with animals; gardening; and engaging in other activities that “self sooth.” I also recommend always doing “small acts of kindness” for others. I myself contribute to food banks and bring cookies or watermelons to the staff at my hospital.
Why is this approach useful? A menu of options gives control back to the patient. It provides activities that can reduce anxiety. Thinking about caring for others helps patients get out of their own “swamp of distress.”
We do live in very difficult times. We’re coping with COVID-19 Delta variant, attacks on the Capitol, and gun violence. I have not yet mentioned climate change, which is extremely frightening to many of us. So all providers need to be aware of all the strategies at our disposal to treat anxiety, depression, and PTSD.
Dr. Ritchie is chair of psychiatry at Medstar Washington (D.C.) Hospital Center. She has no conflicts of interest.
Immune reconstitution inflammatory syndrome: ‘Why is my patient getting worse?’
Over the past 25 years, antiretroviral therapy (ART) has led to a dramatic decrease in HIV-associated morbidity and mortality. Patients who initiate ART today can now expect a nearly normal life expectancy.1 Despite the overwhelming benefits of ART, some patients experience immune reconstitution inflammatory syndrome (IRIS), a disease- or pathogen-specific immune response that can mimic the presentation of an active opportunistic infection (OI). IRIS can occur at any CD4 count. However, it is most often associated with the rapid increase in CD4 count and decrease in viral load that typically follows ART initiation in patients who are severely immunocompromised and have high viral loads.2-6
IRIS manifests in two primary ways. Paradoxical IRIS refers to the worsening of a previously diagnosed disease after ART initiation, whereas unmasking IRIS refers to the appearance of a previously undiagnosed disease following ART initiation.
The Medical Care Criteria Committee of the New York State Department of Health AIDS Institute Clinical Guidelines Program recently published an update to its guideline, Management of IRIS . This update incorporates recent data and summarizes how to identify and manage IRIS associated with several OIs. Important goals of this update were to raise awareness among healthcare providers about IRIS, including its clinical presentation, and provide treatment recommendations.
For most patients, ART should be started quickly
Over the past few years, rapid initiation of ART has become the new standard of care, with same-day initiation on the day of HIV diagnosis recommended whenever possible. For many years, however, the presence of an active OI was felt to justify delaying ART initiation until the OI was completely treated. This approach changed in 2009 when a randomized trial by the AIDS Clinical Trials Group demonstrated that patients who initiated ART within 2 weeks of OI diagnosis did not experience more adverse events than those who waited.7 Moreover, although the finding did not reach statistical significance, participants in the early ART arm appeared to experience lower mortality and progression of AIDS than those in the delayed ART arm. Therefore, patients diagnosed with most OIs can start ART as soon as they are tolerating the treatment for the OI.
Some OIs do require a delay in ART
Symptoms associated with IRIS are typically mild or moderate; life-threatening complications are rare. Most patients newly diagnosed with HIV who have an active OI can therefore initiate ART quickly. However, IRIS involving the central nervous system or eye carries a much greater risk of morbidity and mortality. OIs that do warrant a delay in ART initiation, therefore, include tuberculosis (TB) meningitis, cryptococcal meningitis, and cytomegalovirus (CMV) retinitis.
Several randomized clinical trials have found that in patients with HIV and pulmonary TB coinfection, ART should be started as soon as the patient is tolerating anti-TB therapy.8-10 What’s more, in patients with CD4 counts less than 50 cells/microL, there is a mortality benefit when ART is initiated within 2 weeks of starting TB treatment, compared with waiting 8 weeks.
For TB meningitis, however, a clinical trial conducted in Vietnam did not show any mortality benefit when ART was started within 7 days (vs. 2 months); however, severe adverse events were more common in the immediate ART group, raising the concern that patients in that group had experienced complications of IRIS of the central nervous system.11 Limited data are available to guide specific timing of ART in patients with TB meningitis, but based on the results of this trial, most clinicians wait approximately 2 months before initiating ART, and consultation with an expert is recommended.
Optimal timing of ART in patients with cryptococcal meningitis is also uncertain, and there have been contradictory results from several small studies. However, in 2014, the larger COAT trial, conducted in Uganda and South Africa, found 15% higher mortality in patients who initiated ART within 2 weeks, compared with more than 5 weeks.12 Although exactly how long to wait is still unknown, ART should be delayed by at least 2 weeks after a patient starts antifungal therapy.
CMV-IRIS can have devastating effects, including vision loss or blindness. Therefore, ART initiation should be delayed in patients with diagnosed or strongly suspected CMV.13 Importantly, however, patients with advanced HIV may have asymptomatic or subclinical CMV retinitis. As a result, all patients with HIV who have CD4 counts less than 100 cells/mm3 who do not have known or strongly suspected CMV should be screened for signs of CMV by dilated ophthalmological examination as soon as possible after initiation of ART. If signs of CMV are seen on dilated exam, clinicians should consult with an experienced HIV care provider to determine if ART must be temporarily paused.
Diagnosing IRIS
Broadly, IRIS presents as a clinical deterioration after ART initiation, with localized tissue inflammation, with or without a systemic inflammatory response, but the presentation of IRIS varies depending on the underlying OI or illness. In most cases, IRIS occurs within 4-8 weeks of ART initiation or regimen change. A rise in CD4 count often but does not always precede IRIS and is not a diagnostic criterion. There is no diagnostic test for IRIS, and when assessing a patient for possible IRIS, clinicians should exclude HIV disease progression, new infections, OI drug resistance, OI treatment nonadherence, and drug reactions as possible causes for inflammatory signs or symptoms.
Treatment of IRIS
Most cases of IRIS are mild, and patients can be reassured that the symptoms will resolve with time. Clinicians should interrupt ART only if a patient has a severe, life-threatening case of IRIS. Unnecessary ART interruption may increase a patient’s risk of new opportunistic infections, recurring IRIS upon resumption of ART, and development of HIV-drug resistance. Any newly unmasked OIs should be treated promptly while ART is continued. For patients with severe IRIS, clinicians can use prednisone to treat inflammatory symptoms – generally for 1-2 weeks, followed by a taper as needed. Prednisone, however, should not be used in patients with cryptococcal meningitis or Kaposi sarcoma as it is associated with worse outcomes.14-17
In patients newly diagnosed with HIV, prompt initiation of ART is, with the exceptions outlined above, the highest priority. IRIS is an unfortunate complication of ART, and patients may be discouraged when they find themselves feeling worse shortly after starting treatment. While providing supportive and symptomatic care, clinicians can reassure patients by explaining that immune reconstitution is, in fact, the goal of ART and that their symptoms do not represent the progression of HIV disease. It is hoped that with more frequent HIV testing, earlier diagnosis, and earlier ART initiation at higher CD4 counts, IRIS will become a less frequent nuisance to patients and providers.
Dr. Brust is in the department of medicine at Albert Einstein College of Medicine/Montefiore Medical Center, New York. He reported having no relevant financial relationships. A version of this article first appeared on Medscape.com.
References
1. Marcus JL et al. JAMA Netw Open. 2020;3:e207954.
2. Breton G et al. Clin Infect Dis. 2004;39:1709-12.
3. Shelburne SA et al. Clin Infect Dis. 2005;40:1049-52.
4. Shelburne SA et al. AIDS. 2005;19:399-406.
5. Muller M et al. Lancet Infect Dis. 2010;10:251-61.
6. Novak RM et al. AIDS. 2012;26:721-30.
7. Zolopa A et al. PLoS One. 2009;4:e5575.
8. Havlir DV et al. N Engl J Med. 2011;365:1482-91.
9. Abdool Karim SS et al. N Engl J Med. 2011;365:1492-501.
10. Blanc FX et al. N Engl J Med. 2011;365:1471-81.
11. Torok ME et al. Clin Infect Dis. 2011;52:1374-83.
12. Boulware DR et al. N Engl J Med. 2014;370:2487-98.
13. Ortega-Larrocea G et al. AIDS. 2005;19:735-8.
14. Beardsley J et al. N Engl J Med. 2016;374:542-54.
15. Gill PS, Loureiro C et al. Ann Intern Med. 1989;110:937-40.
16. Elliott AM et al. J Infect Dis. 2004;190:869-78.
17. Volkow PF et al. AIDS. 2008;22:663-5.
Over the past 25 years, antiretroviral therapy (ART) has led to a dramatic decrease in HIV-associated morbidity and mortality. Patients who initiate ART today can now expect a nearly normal life expectancy.1 Despite the overwhelming benefits of ART, some patients experience immune reconstitution inflammatory syndrome (IRIS), a disease- or pathogen-specific immune response that can mimic the presentation of an active opportunistic infection (OI). IRIS can occur at any CD4 count. However, it is most often associated with the rapid increase in CD4 count and decrease in viral load that typically follows ART initiation in patients who are severely immunocompromised and have high viral loads.2-6
IRIS manifests in two primary ways. Paradoxical IRIS refers to the worsening of a previously diagnosed disease after ART initiation, whereas unmasking IRIS refers to the appearance of a previously undiagnosed disease following ART initiation.
The Medical Care Criteria Committee of the New York State Department of Health AIDS Institute Clinical Guidelines Program recently published an update to its guideline, Management of IRIS . This update incorporates recent data and summarizes how to identify and manage IRIS associated with several OIs. Important goals of this update were to raise awareness among healthcare providers about IRIS, including its clinical presentation, and provide treatment recommendations.
For most patients, ART should be started quickly
Over the past few years, rapid initiation of ART has become the new standard of care, with same-day initiation on the day of HIV diagnosis recommended whenever possible. For many years, however, the presence of an active OI was felt to justify delaying ART initiation until the OI was completely treated. This approach changed in 2009 when a randomized trial by the AIDS Clinical Trials Group demonstrated that patients who initiated ART within 2 weeks of OI diagnosis did not experience more adverse events than those who waited.7 Moreover, although the finding did not reach statistical significance, participants in the early ART arm appeared to experience lower mortality and progression of AIDS than those in the delayed ART arm. Therefore, patients diagnosed with most OIs can start ART as soon as they are tolerating the treatment for the OI.
Some OIs do require a delay in ART
Symptoms associated with IRIS are typically mild or moderate; life-threatening complications are rare. Most patients newly diagnosed with HIV who have an active OI can therefore initiate ART quickly. However, IRIS involving the central nervous system or eye carries a much greater risk of morbidity and mortality. OIs that do warrant a delay in ART initiation, therefore, include tuberculosis (TB) meningitis, cryptococcal meningitis, and cytomegalovirus (CMV) retinitis.
Several randomized clinical trials have found that in patients with HIV and pulmonary TB coinfection, ART should be started as soon as the patient is tolerating anti-TB therapy.8-10 What’s more, in patients with CD4 counts less than 50 cells/microL, there is a mortality benefit when ART is initiated within 2 weeks of starting TB treatment, compared with waiting 8 weeks.
For TB meningitis, however, a clinical trial conducted in Vietnam did not show any mortality benefit when ART was started within 7 days (vs. 2 months); however, severe adverse events were more common in the immediate ART group, raising the concern that patients in that group had experienced complications of IRIS of the central nervous system.11 Limited data are available to guide specific timing of ART in patients with TB meningitis, but based on the results of this trial, most clinicians wait approximately 2 months before initiating ART, and consultation with an expert is recommended.
Optimal timing of ART in patients with cryptococcal meningitis is also uncertain, and there have been contradictory results from several small studies. However, in 2014, the larger COAT trial, conducted in Uganda and South Africa, found 15% higher mortality in patients who initiated ART within 2 weeks, compared with more than 5 weeks.12 Although exactly how long to wait is still unknown, ART should be delayed by at least 2 weeks after a patient starts antifungal therapy.
CMV-IRIS can have devastating effects, including vision loss or blindness. Therefore, ART initiation should be delayed in patients with diagnosed or strongly suspected CMV.13 Importantly, however, patients with advanced HIV may have asymptomatic or subclinical CMV retinitis. As a result, all patients with HIV who have CD4 counts less than 100 cells/mm3 who do not have known or strongly suspected CMV should be screened for signs of CMV by dilated ophthalmological examination as soon as possible after initiation of ART. If signs of CMV are seen on dilated exam, clinicians should consult with an experienced HIV care provider to determine if ART must be temporarily paused.
Diagnosing IRIS
Broadly, IRIS presents as a clinical deterioration after ART initiation, with localized tissue inflammation, with or without a systemic inflammatory response, but the presentation of IRIS varies depending on the underlying OI or illness. In most cases, IRIS occurs within 4-8 weeks of ART initiation or regimen change. A rise in CD4 count often but does not always precede IRIS and is not a diagnostic criterion. There is no diagnostic test for IRIS, and when assessing a patient for possible IRIS, clinicians should exclude HIV disease progression, new infections, OI drug resistance, OI treatment nonadherence, and drug reactions as possible causes for inflammatory signs or symptoms.
Treatment of IRIS
Most cases of IRIS are mild, and patients can be reassured that the symptoms will resolve with time. Clinicians should interrupt ART only if a patient has a severe, life-threatening case of IRIS. Unnecessary ART interruption may increase a patient’s risk of new opportunistic infections, recurring IRIS upon resumption of ART, and development of HIV-drug resistance. Any newly unmasked OIs should be treated promptly while ART is continued. For patients with severe IRIS, clinicians can use prednisone to treat inflammatory symptoms – generally for 1-2 weeks, followed by a taper as needed. Prednisone, however, should not be used in patients with cryptococcal meningitis or Kaposi sarcoma as it is associated with worse outcomes.14-17
In patients newly diagnosed with HIV, prompt initiation of ART is, with the exceptions outlined above, the highest priority. IRIS is an unfortunate complication of ART, and patients may be discouraged when they find themselves feeling worse shortly after starting treatment. While providing supportive and symptomatic care, clinicians can reassure patients by explaining that immune reconstitution is, in fact, the goal of ART and that their symptoms do not represent the progression of HIV disease. It is hoped that with more frequent HIV testing, earlier diagnosis, and earlier ART initiation at higher CD4 counts, IRIS will become a less frequent nuisance to patients and providers.
Dr. Brust is in the department of medicine at Albert Einstein College of Medicine/Montefiore Medical Center, New York. He reported having no relevant financial relationships. A version of this article first appeared on Medscape.com.
References
1. Marcus JL et al. JAMA Netw Open. 2020;3:e207954.
2. Breton G et al. Clin Infect Dis. 2004;39:1709-12.
3. Shelburne SA et al. Clin Infect Dis. 2005;40:1049-52.
4. Shelburne SA et al. AIDS. 2005;19:399-406.
5. Muller M et al. Lancet Infect Dis. 2010;10:251-61.
6. Novak RM et al. AIDS. 2012;26:721-30.
7. Zolopa A et al. PLoS One. 2009;4:e5575.
8. Havlir DV et al. N Engl J Med. 2011;365:1482-91.
9. Abdool Karim SS et al. N Engl J Med. 2011;365:1492-501.
10. Blanc FX et al. N Engl J Med. 2011;365:1471-81.
11. Torok ME et al. Clin Infect Dis. 2011;52:1374-83.
12. Boulware DR et al. N Engl J Med. 2014;370:2487-98.
13. Ortega-Larrocea G et al. AIDS. 2005;19:735-8.
14. Beardsley J et al. N Engl J Med. 2016;374:542-54.
15. Gill PS, Loureiro C et al. Ann Intern Med. 1989;110:937-40.
16. Elliott AM et al. J Infect Dis. 2004;190:869-78.
17. Volkow PF et al. AIDS. 2008;22:663-5.
Over the past 25 years, antiretroviral therapy (ART) has led to a dramatic decrease in HIV-associated morbidity and mortality. Patients who initiate ART today can now expect a nearly normal life expectancy.1 Despite the overwhelming benefits of ART, some patients experience immune reconstitution inflammatory syndrome (IRIS), a disease- or pathogen-specific immune response that can mimic the presentation of an active opportunistic infection (OI). IRIS can occur at any CD4 count. However, it is most often associated with the rapid increase in CD4 count and decrease in viral load that typically follows ART initiation in patients who are severely immunocompromised and have high viral loads.2-6
IRIS manifests in two primary ways. Paradoxical IRIS refers to the worsening of a previously diagnosed disease after ART initiation, whereas unmasking IRIS refers to the appearance of a previously undiagnosed disease following ART initiation.
The Medical Care Criteria Committee of the New York State Department of Health AIDS Institute Clinical Guidelines Program recently published an update to its guideline, Management of IRIS . This update incorporates recent data and summarizes how to identify and manage IRIS associated with several OIs. Important goals of this update were to raise awareness among healthcare providers about IRIS, including its clinical presentation, and provide treatment recommendations.
For most patients, ART should be started quickly
Over the past few years, rapid initiation of ART has become the new standard of care, with same-day initiation on the day of HIV diagnosis recommended whenever possible. For many years, however, the presence of an active OI was felt to justify delaying ART initiation until the OI was completely treated. This approach changed in 2009 when a randomized trial by the AIDS Clinical Trials Group demonstrated that patients who initiated ART within 2 weeks of OI diagnosis did not experience more adverse events than those who waited.7 Moreover, although the finding did not reach statistical significance, participants in the early ART arm appeared to experience lower mortality and progression of AIDS than those in the delayed ART arm. Therefore, patients diagnosed with most OIs can start ART as soon as they are tolerating the treatment for the OI.
Some OIs do require a delay in ART
Symptoms associated with IRIS are typically mild or moderate; life-threatening complications are rare. Most patients newly diagnosed with HIV who have an active OI can therefore initiate ART quickly. However, IRIS involving the central nervous system or eye carries a much greater risk of morbidity and mortality. OIs that do warrant a delay in ART initiation, therefore, include tuberculosis (TB) meningitis, cryptococcal meningitis, and cytomegalovirus (CMV) retinitis.
Several randomized clinical trials have found that in patients with HIV and pulmonary TB coinfection, ART should be started as soon as the patient is tolerating anti-TB therapy.8-10 What’s more, in patients with CD4 counts less than 50 cells/microL, there is a mortality benefit when ART is initiated within 2 weeks of starting TB treatment, compared with waiting 8 weeks.
For TB meningitis, however, a clinical trial conducted in Vietnam did not show any mortality benefit when ART was started within 7 days (vs. 2 months); however, severe adverse events were more common in the immediate ART group, raising the concern that patients in that group had experienced complications of IRIS of the central nervous system.11 Limited data are available to guide specific timing of ART in patients with TB meningitis, but based on the results of this trial, most clinicians wait approximately 2 months before initiating ART, and consultation with an expert is recommended.
Optimal timing of ART in patients with cryptococcal meningitis is also uncertain, and there have been contradictory results from several small studies. However, in 2014, the larger COAT trial, conducted in Uganda and South Africa, found 15% higher mortality in patients who initiated ART within 2 weeks, compared with more than 5 weeks.12 Although exactly how long to wait is still unknown, ART should be delayed by at least 2 weeks after a patient starts antifungal therapy.
CMV-IRIS can have devastating effects, including vision loss or blindness. Therefore, ART initiation should be delayed in patients with diagnosed or strongly suspected CMV.13 Importantly, however, patients with advanced HIV may have asymptomatic or subclinical CMV retinitis. As a result, all patients with HIV who have CD4 counts less than 100 cells/mm3 who do not have known or strongly suspected CMV should be screened for signs of CMV by dilated ophthalmological examination as soon as possible after initiation of ART. If signs of CMV are seen on dilated exam, clinicians should consult with an experienced HIV care provider to determine if ART must be temporarily paused.
Diagnosing IRIS
Broadly, IRIS presents as a clinical deterioration after ART initiation, with localized tissue inflammation, with or without a systemic inflammatory response, but the presentation of IRIS varies depending on the underlying OI or illness. In most cases, IRIS occurs within 4-8 weeks of ART initiation or regimen change. A rise in CD4 count often but does not always precede IRIS and is not a diagnostic criterion. There is no diagnostic test for IRIS, and when assessing a patient for possible IRIS, clinicians should exclude HIV disease progression, new infections, OI drug resistance, OI treatment nonadherence, and drug reactions as possible causes for inflammatory signs or symptoms.
Treatment of IRIS
Most cases of IRIS are mild, and patients can be reassured that the symptoms will resolve with time. Clinicians should interrupt ART only if a patient has a severe, life-threatening case of IRIS. Unnecessary ART interruption may increase a patient’s risk of new opportunistic infections, recurring IRIS upon resumption of ART, and development of HIV-drug resistance. Any newly unmasked OIs should be treated promptly while ART is continued. For patients with severe IRIS, clinicians can use prednisone to treat inflammatory symptoms – generally for 1-2 weeks, followed by a taper as needed. Prednisone, however, should not be used in patients with cryptococcal meningitis or Kaposi sarcoma as it is associated with worse outcomes.14-17
In patients newly diagnosed with HIV, prompt initiation of ART is, with the exceptions outlined above, the highest priority. IRIS is an unfortunate complication of ART, and patients may be discouraged when they find themselves feeling worse shortly after starting treatment. While providing supportive and symptomatic care, clinicians can reassure patients by explaining that immune reconstitution is, in fact, the goal of ART and that their symptoms do not represent the progression of HIV disease. It is hoped that with more frequent HIV testing, earlier diagnosis, and earlier ART initiation at higher CD4 counts, IRIS will become a less frequent nuisance to patients and providers.
Dr. Brust is in the department of medicine at Albert Einstein College of Medicine/Montefiore Medical Center, New York. He reported having no relevant financial relationships. A version of this article first appeared on Medscape.com.
References
1. Marcus JL et al. JAMA Netw Open. 2020;3:e207954.
2. Breton G et al. Clin Infect Dis. 2004;39:1709-12.
3. Shelburne SA et al. Clin Infect Dis. 2005;40:1049-52.
4. Shelburne SA et al. AIDS. 2005;19:399-406.
5. Muller M et al. Lancet Infect Dis. 2010;10:251-61.
6. Novak RM et al. AIDS. 2012;26:721-30.
7. Zolopa A et al. PLoS One. 2009;4:e5575.
8. Havlir DV et al. N Engl J Med. 2011;365:1482-91.
9. Abdool Karim SS et al. N Engl J Med. 2011;365:1492-501.
10. Blanc FX et al. N Engl J Med. 2011;365:1471-81.
11. Torok ME et al. Clin Infect Dis. 2011;52:1374-83.
12. Boulware DR et al. N Engl J Med. 2014;370:2487-98.
13. Ortega-Larrocea G et al. AIDS. 2005;19:735-8.
14. Beardsley J et al. N Engl J Med. 2016;374:542-54.
15. Gill PS, Loureiro C et al. Ann Intern Med. 1989;110:937-40.
16. Elliott AM et al. J Infect Dis. 2004;190:869-78.
17. Volkow PF et al. AIDS. 2008;22:663-5.
Obesity treatment in mental illness: Is semaglutide a game changer?
It’s probably fair to say that most people would like to be thinner. More than 42% of Americans have obesity and another 30% are classified as being overweight, according to the latest statistics from the CDC.
Excess body weight is associated with many illnesses and plays a role in mental health; being heavy can take a toll on self-esteem. Many people worry that carrying excess weight makes them less attractive to potential romantic partners, and both physicians and employers treat those with obesity differently. Furthermore, in psychiatry, many of the medications we prescribe lead to weight gain.
In my clinical practice, I have listened as patients blamed themselves for their body habitus; many won’t consider biological treatments as they feel that would be “cheating” or taking an easy way out. They often point to periods in their life when they did lose weight and believe that they should be able to do it again, even if the weight loss took tremendous effort, was not sustained, and occurred decades ago.
That said, we psychiatrists often find ourselves in the position of managing obesity in our patients. I have been known to give patients who gain weight on antipsychotics either stimulants or metformin, or to add naltrexone to their Wellbutrin (bupropion) to effectively mimic a weight-loss medicine called Contrave.
Obesity a treatable medical condition
It wasn’t until 2013 that the American Medical Association recognized obesity as a medical condition.
In a New Yorker article that same year, “Diet Drugs Work: Why Won’t Doctors Prescribe Them?” Suzanne Koven wrote: “Several obesity experts told me they’ve encountered doctors who confide that they just didn’t like fat people and don’t enjoy taking care of them. Even doctors who treat obese patients feel stigmatized: ‘diet doctor’ is not a flattering term.”
Eat less, exercise more – with a blame-the-patient attitude – is still what people see as the “right” way to lose weight.
On June 4, 2021, the FDA approved semaglutide, a glucagonlike peptide–1 receptor agonist, previously used for the treatment of diabetes, for use as a weight loss agent for patients with obesity, or for those with a body mass index over 27 kg/m2 if they also have a weight-related comorbidity.
Semaglutide has three trade names, all manufactured by Novo Nordisk. The pill version is called Rybelsus and comes in 7-mg and 14-mg tablets. Ozempic is available in 0.5-mg and 1.0-mg doses and is administered weekly by subcutaneous injection for diabetes. The new, higher-dose preparation for weight loss, Wegovy, 2.4 mg, also comes as a weekly subcutaneous dose and is now available for the hefty price of $1,400 per month.
In STEP 1 trials, the higher-dose Wegovy was associated with an average 14.9% weight loss (15.3 kg) over 68 weeks, more than any other single-agent weight loss medication on the market.
GLP-1 receptor agonists work in the brain to decrease appetite, slow gastric emptying, increase insulin secretion, and stimulate brown adipose tissue thermogenesis.
Psych drugs lead to weight gain
Elaine Weiner, MD, is the medical director in the outpatient research program of the Maryland Psychiatric Research Center in Catonsville, where she treats patients with schizophrenia.
“Nearly all of our patients gain 20 pounds or more on the combinations of medications we use, mostly atypical antipsychotics,” she said. “Weight management is difficult for people who don’t have problems with motivation, but in our patients, lack of motivation is a core part of their illness, so asking them to adhere to diet and exercise regimens is of limited utility.
“Then, add to that the fact that they sometimes don’t have primary care doctors, and these issues of weight gain and metabolic syndrome come back to the psychiatrist. It is a really bad problem and we need more treatments.”
Fatima Cody Stanford, MD, MPH, MPA, is a fellowship-trained obesity medicine physician-scientist at the Massachusetts General Hospital Weight Center and Harvard Medical School, both in Boston. She has treated thousands of patients with obesity, speaks internationally on the topic of weight loss medicine, and has published over 100 peer-reviewed articles on obesity.
We spoke at length about recent changes in the field of obesity medicine and the introduction of the new GLP-1 receptor agonists.
“We as physicians have learned so little,” Dr. Stanford said. “This mantra of ‘calories in, calories out’ is not working; this is inaccurate and our focus on this has led to a rise in obesity. All calories are not created the same, and I think we are finally starting to see obesity medicine take off.”
Dr. Stanford is quick to note that obesity is a complex problem. Several different hormones are involved in regulating both appetite and satiety, processed foods promote weight gain, sleep is crucial to weight loss, and exercise helps maintain weight loss but is not usually effective in promoting it. “There are many contributors to energy storage,” she said.
The stimulant phentermine was approved in 1959. Addiction was a concern, and then in the 1990s, it was used in combination with fenfluramine to promote weight loss, a combination known as phen-fen. Fenfluramine was pulled from the market in 1997 when it was found to be associated with pulmonary hypertension and then heart valve abnormalities.
“This frightened quite a few physicians,” Dr. Stanford noted. Phentermine is still used for weight loss, either alone or together with topiramate, as a combination medication called Qsymia, nicknamed phen-top.
“Phen-top is the next best thing we have to semaglutide, and there is an average weight loss of 8%-9% of body weight. Semaglutide is going to be really significant for those people who are responders, and this has been quite well tolerated, the most common side effect being nausea,” she said.
However, she is quick to note that not everyone responds to every medication. “I use each patient’s clinical profile to determine what strategies and which medications to use.”
Cardiologists getting in the game
Michael Miller, MD, is a cardiologist at the University of Maryland, Baltimore, and author of “Heal Your Heart” (Emmaus, Pa.: Rodale, 2014). He is very enthusiastic about the approval of semaglutide.
“We are so excited because you finally can use these medicines without having to be diabetic,” Dr. Miller said. “We’re waiting on the results of the SELECT [Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity] trials looking at people who are not diabetic or who are prediabetic, to see the 5-year outcomes with regard to cardiac events.
“Usually endocrinologists prescribe these medications, but cardiologists have started to get into the game since GLP-1 receptor agonists reduce cardiovascular events.” Dr. Miller is hopeful that this medication may neutralize the weight gain caused by psychotropic medications.
Wegovy is administered via weekly injection and, like insulin, is a subcutaneous medication that patients self-administer. Will patients be amenable to injecting a medication for weight loss? Dr. Stanford said that roughly 20%-30% of her patients are hesitant when she suggests that they use liraglutide, another GLP-1 receptor agonist that is approved for weight loss, and some are very fearful of needles.
However, she also noted that during the COVID-19 pandemic, many more patients have sought treatment from obesity medicine physicians because of the association between obesity and mortality from COVID-19. Patients have been willing to consider treatments that they were not previously open to pursuing.
So if people are willing to take Wegovy and doctors are willing to prescribe it, will insurers pay for it? As of this writing, the medication is not yet available, but Ozempic, the lower-dose agent for diabetes, costs $850-$900 for a 4-week supply, according to the GoodRx website.
Liraglutide (Saxenda), the GLP-1 receptor agonist that is currently available for weight loss as a daily injectable, costs $1,300-$1,400 per month.
These medications are not covered by Medicare or Medicaid, and Dr. Stanford, who is well versed as to exactly which private insurers in Massachusetts will and will not reimburse specific medications, said her patients with insurance coverage have been known to delay retirement so that they can remain on the more expensive medications.
“For the past 8 years,” she said, “the Treat and Reduce Obesity Act has had bipartisan support in Congress but has not passed. We are still hopeful that insurers will be required to cover medical and behavioral treatments for obesity.”
As our society struggles to destigmatize so many disorders, obesity remains a highly stigmatized condition, one that our patients cannot hide and one that leads to so many other comorbid illnesses. As new treatments are approved, there will be more for physicians to offer. Semaglutide, if it becomes available to those who need it most, could be a game changer. For patients who have not had success with traditional weight-loss methods, it’s encouraging to have another option available, one that may be reasonable to try before resorting to bariatric surgery.
For decades, psychiatrists have been comfortable prescribing treatments that lead to weight gain. Now, maybe it’s time they also prescribe those that prevent it.
A version of this article first appeared on Medscape.com.
It’s probably fair to say that most people would like to be thinner. More than 42% of Americans have obesity and another 30% are classified as being overweight, according to the latest statistics from the CDC.
Excess body weight is associated with many illnesses and plays a role in mental health; being heavy can take a toll on self-esteem. Many people worry that carrying excess weight makes them less attractive to potential romantic partners, and both physicians and employers treat those with obesity differently. Furthermore, in psychiatry, many of the medications we prescribe lead to weight gain.
In my clinical practice, I have listened as patients blamed themselves for their body habitus; many won’t consider biological treatments as they feel that would be “cheating” or taking an easy way out. They often point to periods in their life when they did lose weight and believe that they should be able to do it again, even if the weight loss took tremendous effort, was not sustained, and occurred decades ago.
That said, we psychiatrists often find ourselves in the position of managing obesity in our patients. I have been known to give patients who gain weight on antipsychotics either stimulants or metformin, or to add naltrexone to their Wellbutrin (bupropion) to effectively mimic a weight-loss medicine called Contrave.
Obesity a treatable medical condition
It wasn’t until 2013 that the American Medical Association recognized obesity as a medical condition.
In a New Yorker article that same year, “Diet Drugs Work: Why Won’t Doctors Prescribe Them?” Suzanne Koven wrote: “Several obesity experts told me they’ve encountered doctors who confide that they just didn’t like fat people and don’t enjoy taking care of them. Even doctors who treat obese patients feel stigmatized: ‘diet doctor’ is not a flattering term.”
Eat less, exercise more – with a blame-the-patient attitude – is still what people see as the “right” way to lose weight.
On June 4, 2021, the FDA approved semaglutide, a glucagonlike peptide–1 receptor agonist, previously used for the treatment of diabetes, for use as a weight loss agent for patients with obesity, or for those with a body mass index over 27 kg/m2 if they also have a weight-related comorbidity.
Semaglutide has three trade names, all manufactured by Novo Nordisk. The pill version is called Rybelsus and comes in 7-mg and 14-mg tablets. Ozempic is available in 0.5-mg and 1.0-mg doses and is administered weekly by subcutaneous injection for diabetes. The new, higher-dose preparation for weight loss, Wegovy, 2.4 mg, also comes as a weekly subcutaneous dose and is now available for the hefty price of $1,400 per month.
In STEP 1 trials, the higher-dose Wegovy was associated with an average 14.9% weight loss (15.3 kg) over 68 weeks, more than any other single-agent weight loss medication on the market.
GLP-1 receptor agonists work in the brain to decrease appetite, slow gastric emptying, increase insulin secretion, and stimulate brown adipose tissue thermogenesis.
Psych drugs lead to weight gain
Elaine Weiner, MD, is the medical director in the outpatient research program of the Maryland Psychiatric Research Center in Catonsville, where she treats patients with schizophrenia.
“Nearly all of our patients gain 20 pounds or more on the combinations of medications we use, mostly atypical antipsychotics,” she said. “Weight management is difficult for people who don’t have problems with motivation, but in our patients, lack of motivation is a core part of their illness, so asking them to adhere to diet and exercise regimens is of limited utility.
“Then, add to that the fact that they sometimes don’t have primary care doctors, and these issues of weight gain and metabolic syndrome come back to the psychiatrist. It is a really bad problem and we need more treatments.”
Fatima Cody Stanford, MD, MPH, MPA, is a fellowship-trained obesity medicine physician-scientist at the Massachusetts General Hospital Weight Center and Harvard Medical School, both in Boston. She has treated thousands of patients with obesity, speaks internationally on the topic of weight loss medicine, and has published over 100 peer-reviewed articles on obesity.
We spoke at length about recent changes in the field of obesity medicine and the introduction of the new GLP-1 receptor agonists.
“We as physicians have learned so little,” Dr. Stanford said. “This mantra of ‘calories in, calories out’ is not working; this is inaccurate and our focus on this has led to a rise in obesity. All calories are not created the same, and I think we are finally starting to see obesity medicine take off.”
Dr. Stanford is quick to note that obesity is a complex problem. Several different hormones are involved in regulating both appetite and satiety, processed foods promote weight gain, sleep is crucial to weight loss, and exercise helps maintain weight loss but is not usually effective in promoting it. “There are many contributors to energy storage,” she said.
The stimulant phentermine was approved in 1959. Addiction was a concern, and then in the 1990s, it was used in combination with fenfluramine to promote weight loss, a combination known as phen-fen. Fenfluramine was pulled from the market in 1997 when it was found to be associated with pulmonary hypertension and then heart valve abnormalities.
“This frightened quite a few physicians,” Dr. Stanford noted. Phentermine is still used for weight loss, either alone or together with topiramate, as a combination medication called Qsymia, nicknamed phen-top.
“Phen-top is the next best thing we have to semaglutide, and there is an average weight loss of 8%-9% of body weight. Semaglutide is going to be really significant for those people who are responders, and this has been quite well tolerated, the most common side effect being nausea,” she said.
However, she is quick to note that not everyone responds to every medication. “I use each patient’s clinical profile to determine what strategies and which medications to use.”
Cardiologists getting in the game
Michael Miller, MD, is a cardiologist at the University of Maryland, Baltimore, and author of “Heal Your Heart” (Emmaus, Pa.: Rodale, 2014). He is very enthusiastic about the approval of semaglutide.
“We are so excited because you finally can use these medicines without having to be diabetic,” Dr. Miller said. “We’re waiting on the results of the SELECT [Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity] trials looking at people who are not diabetic or who are prediabetic, to see the 5-year outcomes with regard to cardiac events.
“Usually endocrinologists prescribe these medications, but cardiologists have started to get into the game since GLP-1 receptor agonists reduce cardiovascular events.” Dr. Miller is hopeful that this medication may neutralize the weight gain caused by psychotropic medications.
Wegovy is administered via weekly injection and, like insulin, is a subcutaneous medication that patients self-administer. Will patients be amenable to injecting a medication for weight loss? Dr. Stanford said that roughly 20%-30% of her patients are hesitant when she suggests that they use liraglutide, another GLP-1 receptor agonist that is approved for weight loss, and some are very fearful of needles.
However, she also noted that during the COVID-19 pandemic, many more patients have sought treatment from obesity medicine physicians because of the association between obesity and mortality from COVID-19. Patients have been willing to consider treatments that they were not previously open to pursuing.
So if people are willing to take Wegovy and doctors are willing to prescribe it, will insurers pay for it? As of this writing, the medication is not yet available, but Ozempic, the lower-dose agent for diabetes, costs $850-$900 for a 4-week supply, according to the GoodRx website.
Liraglutide (Saxenda), the GLP-1 receptor agonist that is currently available for weight loss as a daily injectable, costs $1,300-$1,400 per month.
These medications are not covered by Medicare or Medicaid, and Dr. Stanford, who is well versed as to exactly which private insurers in Massachusetts will and will not reimburse specific medications, said her patients with insurance coverage have been known to delay retirement so that they can remain on the more expensive medications.
“For the past 8 years,” she said, “the Treat and Reduce Obesity Act has had bipartisan support in Congress but has not passed. We are still hopeful that insurers will be required to cover medical and behavioral treatments for obesity.”
As our society struggles to destigmatize so many disorders, obesity remains a highly stigmatized condition, one that our patients cannot hide and one that leads to so many other comorbid illnesses. As new treatments are approved, there will be more for physicians to offer. Semaglutide, if it becomes available to those who need it most, could be a game changer. For patients who have not had success with traditional weight-loss methods, it’s encouraging to have another option available, one that may be reasonable to try before resorting to bariatric surgery.
For decades, psychiatrists have been comfortable prescribing treatments that lead to weight gain. Now, maybe it’s time they also prescribe those that prevent it.
A version of this article first appeared on Medscape.com.
It’s probably fair to say that most people would like to be thinner. More than 42% of Americans have obesity and another 30% are classified as being overweight, according to the latest statistics from the CDC.
Excess body weight is associated with many illnesses and plays a role in mental health; being heavy can take a toll on self-esteem. Many people worry that carrying excess weight makes them less attractive to potential romantic partners, and both physicians and employers treat those with obesity differently. Furthermore, in psychiatry, many of the medications we prescribe lead to weight gain.
In my clinical practice, I have listened as patients blamed themselves for their body habitus; many won’t consider biological treatments as they feel that would be “cheating” or taking an easy way out. They often point to periods in their life when they did lose weight and believe that they should be able to do it again, even if the weight loss took tremendous effort, was not sustained, and occurred decades ago.
That said, we psychiatrists often find ourselves in the position of managing obesity in our patients. I have been known to give patients who gain weight on antipsychotics either stimulants or metformin, or to add naltrexone to their Wellbutrin (bupropion) to effectively mimic a weight-loss medicine called Contrave.
Obesity a treatable medical condition
It wasn’t until 2013 that the American Medical Association recognized obesity as a medical condition.
In a New Yorker article that same year, “Diet Drugs Work: Why Won’t Doctors Prescribe Them?” Suzanne Koven wrote: “Several obesity experts told me they’ve encountered doctors who confide that they just didn’t like fat people and don’t enjoy taking care of them. Even doctors who treat obese patients feel stigmatized: ‘diet doctor’ is not a flattering term.”
Eat less, exercise more – with a blame-the-patient attitude – is still what people see as the “right” way to lose weight.
On June 4, 2021, the FDA approved semaglutide, a glucagonlike peptide–1 receptor agonist, previously used for the treatment of diabetes, for use as a weight loss agent for patients with obesity, or for those with a body mass index over 27 kg/m2 if they also have a weight-related comorbidity.
Semaglutide has three trade names, all manufactured by Novo Nordisk. The pill version is called Rybelsus and comes in 7-mg and 14-mg tablets. Ozempic is available in 0.5-mg and 1.0-mg doses and is administered weekly by subcutaneous injection for diabetes. The new, higher-dose preparation for weight loss, Wegovy, 2.4 mg, also comes as a weekly subcutaneous dose and is now available for the hefty price of $1,400 per month.
In STEP 1 trials, the higher-dose Wegovy was associated with an average 14.9% weight loss (15.3 kg) over 68 weeks, more than any other single-agent weight loss medication on the market.
GLP-1 receptor agonists work in the brain to decrease appetite, slow gastric emptying, increase insulin secretion, and stimulate brown adipose tissue thermogenesis.
Psych drugs lead to weight gain
Elaine Weiner, MD, is the medical director in the outpatient research program of the Maryland Psychiatric Research Center in Catonsville, where she treats patients with schizophrenia.
“Nearly all of our patients gain 20 pounds or more on the combinations of medications we use, mostly atypical antipsychotics,” she said. “Weight management is difficult for people who don’t have problems with motivation, but in our patients, lack of motivation is a core part of their illness, so asking them to adhere to diet and exercise regimens is of limited utility.
“Then, add to that the fact that they sometimes don’t have primary care doctors, and these issues of weight gain and metabolic syndrome come back to the psychiatrist. It is a really bad problem and we need more treatments.”
Fatima Cody Stanford, MD, MPH, MPA, is a fellowship-trained obesity medicine physician-scientist at the Massachusetts General Hospital Weight Center and Harvard Medical School, both in Boston. She has treated thousands of patients with obesity, speaks internationally on the topic of weight loss medicine, and has published over 100 peer-reviewed articles on obesity.
We spoke at length about recent changes in the field of obesity medicine and the introduction of the new GLP-1 receptor agonists.
“We as physicians have learned so little,” Dr. Stanford said. “This mantra of ‘calories in, calories out’ is not working; this is inaccurate and our focus on this has led to a rise in obesity. All calories are not created the same, and I think we are finally starting to see obesity medicine take off.”
Dr. Stanford is quick to note that obesity is a complex problem. Several different hormones are involved in regulating both appetite and satiety, processed foods promote weight gain, sleep is crucial to weight loss, and exercise helps maintain weight loss but is not usually effective in promoting it. “There are many contributors to energy storage,” she said.
The stimulant phentermine was approved in 1959. Addiction was a concern, and then in the 1990s, it was used in combination with fenfluramine to promote weight loss, a combination known as phen-fen. Fenfluramine was pulled from the market in 1997 when it was found to be associated with pulmonary hypertension and then heart valve abnormalities.
“This frightened quite a few physicians,” Dr. Stanford noted. Phentermine is still used for weight loss, either alone or together with topiramate, as a combination medication called Qsymia, nicknamed phen-top.
“Phen-top is the next best thing we have to semaglutide, and there is an average weight loss of 8%-9% of body weight. Semaglutide is going to be really significant for those people who are responders, and this has been quite well tolerated, the most common side effect being nausea,” she said.
However, she is quick to note that not everyone responds to every medication. “I use each patient’s clinical profile to determine what strategies and which medications to use.”
Cardiologists getting in the game
Michael Miller, MD, is a cardiologist at the University of Maryland, Baltimore, and author of “Heal Your Heart” (Emmaus, Pa.: Rodale, 2014). He is very enthusiastic about the approval of semaglutide.
“We are so excited because you finally can use these medicines without having to be diabetic,” Dr. Miller said. “We’re waiting on the results of the SELECT [Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity] trials looking at people who are not diabetic or who are prediabetic, to see the 5-year outcomes with regard to cardiac events.
“Usually endocrinologists prescribe these medications, but cardiologists have started to get into the game since GLP-1 receptor agonists reduce cardiovascular events.” Dr. Miller is hopeful that this medication may neutralize the weight gain caused by psychotropic medications.
Wegovy is administered via weekly injection and, like insulin, is a subcutaneous medication that patients self-administer. Will patients be amenable to injecting a medication for weight loss? Dr. Stanford said that roughly 20%-30% of her patients are hesitant when she suggests that they use liraglutide, another GLP-1 receptor agonist that is approved for weight loss, and some are very fearful of needles.
However, she also noted that during the COVID-19 pandemic, many more patients have sought treatment from obesity medicine physicians because of the association between obesity and mortality from COVID-19. Patients have been willing to consider treatments that they were not previously open to pursuing.
So if people are willing to take Wegovy and doctors are willing to prescribe it, will insurers pay for it? As of this writing, the medication is not yet available, but Ozempic, the lower-dose agent for diabetes, costs $850-$900 for a 4-week supply, according to the GoodRx website.
Liraglutide (Saxenda), the GLP-1 receptor agonist that is currently available for weight loss as a daily injectable, costs $1,300-$1,400 per month.
These medications are not covered by Medicare or Medicaid, and Dr. Stanford, who is well versed as to exactly which private insurers in Massachusetts will and will not reimburse specific medications, said her patients with insurance coverage have been known to delay retirement so that they can remain on the more expensive medications.
“For the past 8 years,” she said, “the Treat and Reduce Obesity Act has had bipartisan support in Congress but has not passed. We are still hopeful that insurers will be required to cover medical and behavioral treatments for obesity.”
As our society struggles to destigmatize so many disorders, obesity remains a highly stigmatized condition, one that our patients cannot hide and one that leads to so many other comorbid illnesses. As new treatments are approved, there will be more for physicians to offer. Semaglutide, if it becomes available to those who need it most, could be a game changer. For patients who have not had success with traditional weight-loss methods, it’s encouraging to have another option available, one that may be reasonable to try before resorting to bariatric surgery.
For decades, psychiatrists have been comfortable prescribing treatments that lead to weight gain. Now, maybe it’s time they also prescribe those that prevent it.
A version of this article first appeared on Medscape.com.
Let’s talk about race
“I feel like my aggression is being racialized.” “Of course I wouldn’t call the cops if I felt like hurting myself. I’m Black.”
Those statements represent the heightened trauma our Black and Brown patients with mental health issues have been experiencing. In the wake of increasingly publicized police brutality against Black and Brown communities, the role race plays in mental health decompensation is evident. At this moment in time, we must continue to improve our understanding of the role race plays in psychiatric disorders. We must also ask ourselves: At times, does psychiatry worsen the traumas of the communities we serve?
Some psychiatrists are afraid to speak about race. They may believe it to be too “political.” But avoiding these necessary conversations perpetuates the trauma of those we treat. It suggests that physicians are ignorant of an issue at the forefront of patients’ mental health. Psychiatry, today, is primarily focused on the biological aspects of disease. We must not forget that psychiatry is biopsychosocial. It is imperative that psychiatrists have conversations about race – and its significance to our patients and their care.
Only 10.4% of psychiatrists in the United States comprise those considered underrepresented in medicine (URM). Yet, those very groups make up 32.6% of the U.S. population and are overrepresented in psychiatric hospitals.1 Many studies have shown that concordant racial backgrounds between patient and physician lead to a more positive patient experience2 and arguably, the subsequent potential for better health outcomes. Our efforts in addressing this disparity often fall short. URM applicants may be hesitant to join an institution where diversity is lacking or where they may be the only minority.3 While there is no simple solution, I propose that psychiatrists promote the importance of mental health to Black and Brown students of all ages by collaborating with schools and community leaders.
It is important to acknowledge that the lack of diversity within psychiatry is reflective of that among all physicians. This in part stems from the barriers to medical education that Black and Brown communities face. Those who start off with more resources or have parents who are physicians are at an advantage when trying to get into medical school. In fact, one in five medical students have a parent who is a physician4 and about three-fourths of students come from families whose income falls among the top two quintiles.5 Impoverished communities, which have a disproportionate share of Black and Brown people, cannot afford to take MCAT preparatory classes or to accept unpaid “resume building” opportunities. Many medical schools continue to place more weight on test scores and research/medical experiences, despite a shift to a more holistic review process. Institutions that have tried a different approach and accepted students from more diverse backgrounds may often overlook the challenges that URM students face while in medical school and fail to provide appropriate support resources.
The result is a failure to retain such students. A study conducted at Stony Brook (N.Y.) University showed that those underrepresented in medicine were six times more likely to get dismissed from medical school, and three times more likely to both withdraw or graduate beyond 4 years, compared with their White counterparts.6 This is a serious issue that needs to change on a structural and systemic level.
Any discussion of race and psychiatry must acknowledge psychiatry’s history of racism against Black and Brown communities to engage in racially informed discussions with our patients. Only then can we play a better role advocating against racism within the field in the future. Dating back to the 18th century, psychiatry has promoted ideologies that promote racism. Benjamin Rush, considered the “father of American Psychiatry,” believed that Black skin was a disease derived from leprosy called “negritude.” In the late 19th century, this twisted ideology continued with the invention of the term “drapetomania,” which was used to describe enslaved people who ran away as having a mental disorder.7 Black prisoners were subjected to experimental treatment with substances such as LSD and bulbocapnine to subdue them.8 This idea that minorities were dangerous and needed to be subdued translated into a higher number of schizophrenia diagnoses, particularly among Black men, as it was used as a tool to vilify them in the 1970s. Although schizophrenia is equally prevalent among Whites and non-Whites, Black people are four times more likely to be diagnosed, compared with their White counterparts, while Hispanics are three times more likely. Studies have shown that Black and Brown men are also more likely to receive higher doses of antipsychotics.9
Given this history, it is not surprising that Black and Brown representation within the field is lacking and that patients may be hesitant to share their feelings about race with us. While we can’t change history, we can take a stance condemning the harmful behavior of the past. The American Psychiatric Association issued an apology earlier this year to Black, Indigenous, and People of Color for its support in structural racism.10 This is a step in the right direction, but we need more than statements or performative actions. We need to amplify the voices of Black and Brown psychiatrists and patients, as well as highlight their current and past contributions to the field. While my educational experiences focused on the work of prominent White scholars, medical curricula should showcase the work of people like Solomon Carter Fuller, MD, a Black psychiatrist who was essential to understanding Alzheimer’s, or Joseph White, PhD, sometimes referred to as the “godfather of Black psychology.”11
At times, I have found myself witness to situations where colleagues make statements that not only do not condemn racism, but in fact encourage it. I have unfortunately heard some use the all-too-familiar rhetoric of reverse racism, such as: “They just assume I am racist because I am a White male” or “They’re being racist against me” or statements like “Don’t you think it is far-fetched to believe she was just sitting on a college campus doing nothing when the police were called?” Rhetoric such as this is problematic to the field of psychiatry and medicine as a whole – and only serves to further invalidate the feelings of our Black and Brown patients. We must increase exposure and education regarding racism to address this, especially the meaning of microaggressions, a concept many fail to understand.
Attention to the subject of racism has increased within medical schools and residency training programs in the wake of George Floyd’s death. However, most programs often make these lectures optional or only have one to two limited sessions. Furthermore, many do not make it mandatory for faculty to attend; they are arguably the most in need of this training given that they set the precedent of how to practice psychiatry. Some institutions have incorporated comprehensive antiracist curriculums into medical training. One model that has been successful is the Social Justice and Health Equity program within Yale University’s psychiatry residency. The curriculum has four tracks:
- Structural competency, which focuses on the mental health impact of extraclinical structures, for example a patient’s neighborhood and associated barriers of access.
- Human experience, which explores the interaction of patients and providers and how biases play a role.
- Advocacy, which teaches residents the written and oral skills to lobby for patient interests on a community and legislative level.
- History of psychiatry, which focuses on understanding psychiatry’s prior role in racism.
In each track, there are group discussions, cases led by faculty, and meetings with community leaders. Through this curriculum, residents learn about power, privilege, and how to interact with and advocate for patients in a way that promotes equity, rather than racial disparity.12,13 This is a model that other psychiatric residency programs can promote, emulate, and benefit from.
Educating ourselves will hopefully lead to a deeper introspection of how we interact with patients and if we are promoting antiracism through our attitude and actions. Reflecting on my own personal practice, I have noted that the interplay of race, mental health, and provider decision-making becomes particularly complex when dealing with situations in which a patient exhibits increased aggression or agitation. As a second-year psychiatric resident immersed in the inpatient world, I have become familiar with patients at higher risk and greater need. The first attempt toward de-escalation involves verbal cues without any other more intrusive measures. If that fails, intramuscular (IM) medications are typically considered. If a patient has a history of aggressive behavior, the threshold to use IM medications can decrease dramatically. This is mainly to protect ourselves and our nursing staff and to prioritize safety. While I understand this rationale, I wonder about the patient’s experience. What constitutes “aggressive” behavior? For patients who have had violence used against them because of their race or who have suffered from police brutality, having police present or threatening IM medications will increasingly trigger them and escalate the situation. The aftermath can deepen the distrust of psychiatry by Black and Brown people.
How do we then handle such situations in a way that both protects our staff from physical harm and protects our patients from racial trauma? While I don’t have a great answer, I think we can benefit from standardizing what we consider aggressive behavior and have specific criteria that patients need to exhibit before administering an IM medication. In addition, discussions with the team, including residents, nurses, and attending physicians, about how to address an emergent situation before it actually happens are essential. Specifically discussing the patient’s history and race and how it may affect the situation is not something to be shied away from. Lastly, in the event that an IM medication is administered and police are present, debriefing with the patient afterward is necessary. The patient may not be willing or able to listen to you or trust you, but taking accountability and acknowledging what happened, justified or not, is a part of the process of rebuilding rapport.
Both in the purview of the individual psychiatrist and the field of psychiatry as a whole, we need to examine our behavior and not be afraid to make changes for the betterment of our patients. We must learn to talk about race with our patients and in the process, advocate for more representation of Black and Brown psychiatrists, understanding the barriers faced by these communities when pursuing the medical field. We must educate ourselves on psychiatry’s history, and equip ourselves with knowledge and tools to promote antiracism and shape psychiatry’s future. We can then apply these very tools to challenging situations we may encounter daily with the ultimate goal of improving the mental health of our patients. This is the only way we will progress and ensure that psychiatry is an equitable, antiracist field. As Ibram X. Kendi, PhD, has written, “The heartbeat of antiracism is self-reflection, recognition, admission, and fundamentally self-critique.”
Dr. Malik is a second-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.
References
1. Wyse R et al. Acad Psychiatry. 2020 Oct;44(5):523-30.
2. Cooper LA et al. Ann Intern Med. 2003;139:907-15.
3. Pierre JM et al. Acad Psychiatry. 2017;41:226-32.
4. Hartocollis A. “Getting into med school without hard sciences.” New York Times. 2010 Jul 29.
5. AAMC. An updated look at the economic diversity of U.S. medical students. Analysis in Brief. 2018 Oct;18(5).
6. Rainey ML. How do we retain minority health professions students. In: Smedley BD et al. The right thing to do, the smart thing to do: Enhancing diversity in the health professions: Summary of the Symposium on Diversity in Health Professions in Honor of Herbert W. Nickens, M.D. Institute of Medicine. National Academies Press. 2001.
7. Geller J. “Structural racism in American psychiatry and APA: Part 1.” Psychiatric News. 2020 Jun 23.
8. Mohr CL and Gordon JE. Tulane: The emergence of a modern university, 1945-1980. Louisiana State University Press, Baton Rouge. 2001.
9. Metzl JM. The protest psychosis: How schizophrenia became a Black disease. Beacon Press. 2010.
10. APA’s apology to Black, indigenous and people of color for its support of structural racism in psychiatry. American Psychiatric Association. 2021 Jan 18.
11. Black pioneers in mental health. Mental Health America. 2021.
12. Belli B. For Yale’s emerging psychiatrists, confronting racism is in the curriculum. Yale News. 2020 Jul 30.
13. Jordan A and Jackson D. Social justice and health equity curriculum. Yale School of Medicine. 2019 Sep 24.
“I feel like my aggression is being racialized.” “Of course I wouldn’t call the cops if I felt like hurting myself. I’m Black.”
Those statements represent the heightened trauma our Black and Brown patients with mental health issues have been experiencing. In the wake of increasingly publicized police brutality against Black and Brown communities, the role race plays in mental health decompensation is evident. At this moment in time, we must continue to improve our understanding of the role race plays in psychiatric disorders. We must also ask ourselves: At times, does psychiatry worsen the traumas of the communities we serve?
Some psychiatrists are afraid to speak about race. They may believe it to be too “political.” But avoiding these necessary conversations perpetuates the trauma of those we treat. It suggests that physicians are ignorant of an issue at the forefront of patients’ mental health. Psychiatry, today, is primarily focused on the biological aspects of disease. We must not forget that psychiatry is biopsychosocial. It is imperative that psychiatrists have conversations about race – and its significance to our patients and their care.
Only 10.4% of psychiatrists in the United States comprise those considered underrepresented in medicine (URM). Yet, those very groups make up 32.6% of the U.S. population and are overrepresented in psychiatric hospitals.1 Many studies have shown that concordant racial backgrounds between patient and physician lead to a more positive patient experience2 and arguably, the subsequent potential for better health outcomes. Our efforts in addressing this disparity often fall short. URM applicants may be hesitant to join an institution where diversity is lacking or where they may be the only minority.3 While there is no simple solution, I propose that psychiatrists promote the importance of mental health to Black and Brown students of all ages by collaborating with schools and community leaders.
It is important to acknowledge that the lack of diversity within psychiatry is reflective of that among all physicians. This in part stems from the barriers to medical education that Black and Brown communities face. Those who start off with more resources or have parents who are physicians are at an advantage when trying to get into medical school. In fact, one in five medical students have a parent who is a physician4 and about three-fourths of students come from families whose income falls among the top two quintiles.5 Impoverished communities, which have a disproportionate share of Black and Brown people, cannot afford to take MCAT preparatory classes or to accept unpaid “resume building” opportunities. Many medical schools continue to place more weight on test scores and research/medical experiences, despite a shift to a more holistic review process. Institutions that have tried a different approach and accepted students from more diverse backgrounds may often overlook the challenges that URM students face while in medical school and fail to provide appropriate support resources.
The result is a failure to retain such students. A study conducted at Stony Brook (N.Y.) University showed that those underrepresented in medicine were six times more likely to get dismissed from medical school, and three times more likely to both withdraw or graduate beyond 4 years, compared with their White counterparts.6 This is a serious issue that needs to change on a structural and systemic level.
Any discussion of race and psychiatry must acknowledge psychiatry’s history of racism against Black and Brown communities to engage in racially informed discussions with our patients. Only then can we play a better role advocating against racism within the field in the future. Dating back to the 18th century, psychiatry has promoted ideologies that promote racism. Benjamin Rush, considered the “father of American Psychiatry,” believed that Black skin was a disease derived from leprosy called “negritude.” In the late 19th century, this twisted ideology continued with the invention of the term “drapetomania,” which was used to describe enslaved people who ran away as having a mental disorder.7 Black prisoners were subjected to experimental treatment with substances such as LSD and bulbocapnine to subdue them.8 This idea that minorities were dangerous and needed to be subdued translated into a higher number of schizophrenia diagnoses, particularly among Black men, as it was used as a tool to vilify them in the 1970s. Although schizophrenia is equally prevalent among Whites and non-Whites, Black people are four times more likely to be diagnosed, compared with their White counterparts, while Hispanics are three times more likely. Studies have shown that Black and Brown men are also more likely to receive higher doses of antipsychotics.9
Given this history, it is not surprising that Black and Brown representation within the field is lacking and that patients may be hesitant to share their feelings about race with us. While we can’t change history, we can take a stance condemning the harmful behavior of the past. The American Psychiatric Association issued an apology earlier this year to Black, Indigenous, and People of Color for its support in structural racism.10 This is a step in the right direction, but we need more than statements or performative actions. We need to amplify the voices of Black and Brown psychiatrists and patients, as well as highlight their current and past contributions to the field. While my educational experiences focused on the work of prominent White scholars, medical curricula should showcase the work of people like Solomon Carter Fuller, MD, a Black psychiatrist who was essential to understanding Alzheimer’s, or Joseph White, PhD, sometimes referred to as the “godfather of Black psychology.”11
At times, I have found myself witness to situations where colleagues make statements that not only do not condemn racism, but in fact encourage it. I have unfortunately heard some use the all-too-familiar rhetoric of reverse racism, such as: “They just assume I am racist because I am a White male” or “They’re being racist against me” or statements like “Don’t you think it is far-fetched to believe she was just sitting on a college campus doing nothing when the police were called?” Rhetoric such as this is problematic to the field of psychiatry and medicine as a whole – and only serves to further invalidate the feelings of our Black and Brown patients. We must increase exposure and education regarding racism to address this, especially the meaning of microaggressions, a concept many fail to understand.
Attention to the subject of racism has increased within medical schools and residency training programs in the wake of George Floyd’s death. However, most programs often make these lectures optional or only have one to two limited sessions. Furthermore, many do not make it mandatory for faculty to attend; they are arguably the most in need of this training given that they set the precedent of how to practice psychiatry. Some institutions have incorporated comprehensive antiracist curriculums into medical training. One model that has been successful is the Social Justice and Health Equity program within Yale University’s psychiatry residency. The curriculum has four tracks:
- Structural competency, which focuses on the mental health impact of extraclinical structures, for example a patient’s neighborhood and associated barriers of access.
- Human experience, which explores the interaction of patients and providers and how biases play a role.
- Advocacy, which teaches residents the written and oral skills to lobby for patient interests on a community and legislative level.
- History of psychiatry, which focuses on understanding psychiatry’s prior role in racism.
In each track, there are group discussions, cases led by faculty, and meetings with community leaders. Through this curriculum, residents learn about power, privilege, and how to interact with and advocate for patients in a way that promotes equity, rather than racial disparity.12,13 This is a model that other psychiatric residency programs can promote, emulate, and benefit from.
Educating ourselves will hopefully lead to a deeper introspection of how we interact with patients and if we are promoting antiracism through our attitude and actions. Reflecting on my own personal practice, I have noted that the interplay of race, mental health, and provider decision-making becomes particularly complex when dealing with situations in which a patient exhibits increased aggression or agitation. As a second-year psychiatric resident immersed in the inpatient world, I have become familiar with patients at higher risk and greater need. The first attempt toward de-escalation involves verbal cues without any other more intrusive measures. If that fails, intramuscular (IM) medications are typically considered. If a patient has a history of aggressive behavior, the threshold to use IM medications can decrease dramatically. This is mainly to protect ourselves and our nursing staff and to prioritize safety. While I understand this rationale, I wonder about the patient’s experience. What constitutes “aggressive” behavior? For patients who have had violence used against them because of their race or who have suffered from police brutality, having police present or threatening IM medications will increasingly trigger them and escalate the situation. The aftermath can deepen the distrust of psychiatry by Black and Brown people.
How do we then handle such situations in a way that both protects our staff from physical harm and protects our patients from racial trauma? While I don’t have a great answer, I think we can benefit from standardizing what we consider aggressive behavior and have specific criteria that patients need to exhibit before administering an IM medication. In addition, discussions with the team, including residents, nurses, and attending physicians, about how to address an emergent situation before it actually happens are essential. Specifically discussing the patient’s history and race and how it may affect the situation is not something to be shied away from. Lastly, in the event that an IM medication is administered and police are present, debriefing with the patient afterward is necessary. The patient may not be willing or able to listen to you or trust you, but taking accountability and acknowledging what happened, justified or not, is a part of the process of rebuilding rapport.
Both in the purview of the individual psychiatrist and the field of psychiatry as a whole, we need to examine our behavior and not be afraid to make changes for the betterment of our patients. We must learn to talk about race with our patients and in the process, advocate for more representation of Black and Brown psychiatrists, understanding the barriers faced by these communities when pursuing the medical field. We must educate ourselves on psychiatry’s history, and equip ourselves with knowledge and tools to promote antiracism and shape psychiatry’s future. We can then apply these very tools to challenging situations we may encounter daily with the ultimate goal of improving the mental health of our patients. This is the only way we will progress and ensure that psychiatry is an equitable, antiracist field. As Ibram X. Kendi, PhD, has written, “The heartbeat of antiracism is self-reflection, recognition, admission, and fundamentally self-critique.”
Dr. Malik is a second-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.
References
1. Wyse R et al. Acad Psychiatry. 2020 Oct;44(5):523-30.
2. Cooper LA et al. Ann Intern Med. 2003;139:907-15.
3. Pierre JM et al. Acad Psychiatry. 2017;41:226-32.
4. Hartocollis A. “Getting into med school without hard sciences.” New York Times. 2010 Jul 29.
5. AAMC. An updated look at the economic diversity of U.S. medical students. Analysis in Brief. 2018 Oct;18(5).
6. Rainey ML. How do we retain minority health professions students. In: Smedley BD et al. The right thing to do, the smart thing to do: Enhancing diversity in the health professions: Summary of the Symposium on Diversity in Health Professions in Honor of Herbert W. Nickens, M.D. Institute of Medicine. National Academies Press. 2001.
7. Geller J. “Structural racism in American psychiatry and APA: Part 1.” Psychiatric News. 2020 Jun 23.
8. Mohr CL and Gordon JE. Tulane: The emergence of a modern university, 1945-1980. Louisiana State University Press, Baton Rouge. 2001.
9. Metzl JM. The protest psychosis: How schizophrenia became a Black disease. Beacon Press. 2010.
10. APA’s apology to Black, indigenous and people of color for its support of structural racism in psychiatry. American Psychiatric Association. 2021 Jan 18.
11. Black pioneers in mental health. Mental Health America. 2021.
12. Belli B. For Yale’s emerging psychiatrists, confronting racism is in the curriculum. Yale News. 2020 Jul 30.
13. Jordan A and Jackson D. Social justice and health equity curriculum. Yale School of Medicine. 2019 Sep 24.
“I feel like my aggression is being racialized.” “Of course I wouldn’t call the cops if I felt like hurting myself. I’m Black.”
Those statements represent the heightened trauma our Black and Brown patients with mental health issues have been experiencing. In the wake of increasingly publicized police brutality against Black and Brown communities, the role race plays in mental health decompensation is evident. At this moment in time, we must continue to improve our understanding of the role race plays in psychiatric disorders. We must also ask ourselves: At times, does psychiatry worsen the traumas of the communities we serve?
Some psychiatrists are afraid to speak about race. They may believe it to be too “political.” But avoiding these necessary conversations perpetuates the trauma of those we treat. It suggests that physicians are ignorant of an issue at the forefront of patients’ mental health. Psychiatry, today, is primarily focused on the biological aspects of disease. We must not forget that psychiatry is biopsychosocial. It is imperative that psychiatrists have conversations about race – and its significance to our patients and their care.
Only 10.4% of psychiatrists in the United States comprise those considered underrepresented in medicine (URM). Yet, those very groups make up 32.6% of the U.S. population and are overrepresented in psychiatric hospitals.1 Many studies have shown that concordant racial backgrounds between patient and physician lead to a more positive patient experience2 and arguably, the subsequent potential for better health outcomes. Our efforts in addressing this disparity often fall short. URM applicants may be hesitant to join an institution where diversity is lacking or where they may be the only minority.3 While there is no simple solution, I propose that psychiatrists promote the importance of mental health to Black and Brown students of all ages by collaborating with schools and community leaders.
It is important to acknowledge that the lack of diversity within psychiatry is reflective of that among all physicians. This in part stems from the barriers to medical education that Black and Brown communities face. Those who start off with more resources or have parents who are physicians are at an advantage when trying to get into medical school. In fact, one in five medical students have a parent who is a physician4 and about three-fourths of students come from families whose income falls among the top two quintiles.5 Impoverished communities, which have a disproportionate share of Black and Brown people, cannot afford to take MCAT preparatory classes or to accept unpaid “resume building” opportunities. Many medical schools continue to place more weight on test scores and research/medical experiences, despite a shift to a more holistic review process. Institutions that have tried a different approach and accepted students from more diverse backgrounds may often overlook the challenges that URM students face while in medical school and fail to provide appropriate support resources.
The result is a failure to retain such students. A study conducted at Stony Brook (N.Y.) University showed that those underrepresented in medicine were six times more likely to get dismissed from medical school, and three times more likely to both withdraw or graduate beyond 4 years, compared with their White counterparts.6 This is a serious issue that needs to change on a structural and systemic level.
Any discussion of race and psychiatry must acknowledge psychiatry’s history of racism against Black and Brown communities to engage in racially informed discussions with our patients. Only then can we play a better role advocating against racism within the field in the future. Dating back to the 18th century, psychiatry has promoted ideologies that promote racism. Benjamin Rush, considered the “father of American Psychiatry,” believed that Black skin was a disease derived from leprosy called “negritude.” In the late 19th century, this twisted ideology continued with the invention of the term “drapetomania,” which was used to describe enslaved people who ran away as having a mental disorder.7 Black prisoners were subjected to experimental treatment with substances such as LSD and bulbocapnine to subdue them.8 This idea that minorities were dangerous and needed to be subdued translated into a higher number of schizophrenia diagnoses, particularly among Black men, as it was used as a tool to vilify them in the 1970s. Although schizophrenia is equally prevalent among Whites and non-Whites, Black people are four times more likely to be diagnosed, compared with their White counterparts, while Hispanics are three times more likely. Studies have shown that Black and Brown men are also more likely to receive higher doses of antipsychotics.9
Given this history, it is not surprising that Black and Brown representation within the field is lacking and that patients may be hesitant to share their feelings about race with us. While we can’t change history, we can take a stance condemning the harmful behavior of the past. The American Psychiatric Association issued an apology earlier this year to Black, Indigenous, and People of Color for its support in structural racism.10 This is a step in the right direction, but we need more than statements or performative actions. We need to amplify the voices of Black and Brown psychiatrists and patients, as well as highlight their current and past contributions to the field. While my educational experiences focused on the work of prominent White scholars, medical curricula should showcase the work of people like Solomon Carter Fuller, MD, a Black psychiatrist who was essential to understanding Alzheimer’s, or Joseph White, PhD, sometimes referred to as the “godfather of Black psychology.”11
At times, I have found myself witness to situations where colleagues make statements that not only do not condemn racism, but in fact encourage it. I have unfortunately heard some use the all-too-familiar rhetoric of reverse racism, such as: “They just assume I am racist because I am a White male” or “They’re being racist against me” or statements like “Don’t you think it is far-fetched to believe she was just sitting on a college campus doing nothing when the police were called?” Rhetoric such as this is problematic to the field of psychiatry and medicine as a whole – and only serves to further invalidate the feelings of our Black and Brown patients. We must increase exposure and education regarding racism to address this, especially the meaning of microaggressions, a concept many fail to understand.
Attention to the subject of racism has increased within medical schools and residency training programs in the wake of George Floyd’s death. However, most programs often make these lectures optional or only have one to two limited sessions. Furthermore, many do not make it mandatory for faculty to attend; they are arguably the most in need of this training given that they set the precedent of how to practice psychiatry. Some institutions have incorporated comprehensive antiracist curriculums into medical training. One model that has been successful is the Social Justice and Health Equity program within Yale University’s psychiatry residency. The curriculum has four tracks:
- Structural competency, which focuses on the mental health impact of extraclinical structures, for example a patient’s neighborhood and associated barriers of access.
- Human experience, which explores the interaction of patients and providers and how biases play a role.
- Advocacy, which teaches residents the written and oral skills to lobby for patient interests on a community and legislative level.
- History of psychiatry, which focuses on understanding psychiatry’s prior role in racism.
In each track, there are group discussions, cases led by faculty, and meetings with community leaders. Through this curriculum, residents learn about power, privilege, and how to interact with and advocate for patients in a way that promotes equity, rather than racial disparity.12,13 This is a model that other psychiatric residency programs can promote, emulate, and benefit from.
Educating ourselves will hopefully lead to a deeper introspection of how we interact with patients and if we are promoting antiracism through our attitude and actions. Reflecting on my own personal practice, I have noted that the interplay of race, mental health, and provider decision-making becomes particularly complex when dealing with situations in which a patient exhibits increased aggression or agitation. As a second-year psychiatric resident immersed in the inpatient world, I have become familiar with patients at higher risk and greater need. The first attempt toward de-escalation involves verbal cues without any other more intrusive measures. If that fails, intramuscular (IM) medications are typically considered. If a patient has a history of aggressive behavior, the threshold to use IM medications can decrease dramatically. This is mainly to protect ourselves and our nursing staff and to prioritize safety. While I understand this rationale, I wonder about the patient’s experience. What constitutes “aggressive” behavior? For patients who have had violence used against them because of their race or who have suffered from police brutality, having police present or threatening IM medications will increasingly trigger them and escalate the situation. The aftermath can deepen the distrust of psychiatry by Black and Brown people.
How do we then handle such situations in a way that both protects our staff from physical harm and protects our patients from racial trauma? While I don’t have a great answer, I think we can benefit from standardizing what we consider aggressive behavior and have specific criteria that patients need to exhibit before administering an IM medication. In addition, discussions with the team, including residents, nurses, and attending physicians, about how to address an emergent situation before it actually happens are essential. Specifically discussing the patient’s history and race and how it may affect the situation is not something to be shied away from. Lastly, in the event that an IM medication is administered and police are present, debriefing with the patient afterward is necessary. The patient may not be willing or able to listen to you or trust you, but taking accountability and acknowledging what happened, justified or not, is a part of the process of rebuilding rapport.
Both in the purview of the individual psychiatrist and the field of psychiatry as a whole, we need to examine our behavior and not be afraid to make changes for the betterment of our patients. We must learn to talk about race with our patients and in the process, advocate for more representation of Black and Brown psychiatrists, understanding the barriers faced by these communities when pursuing the medical field. We must educate ourselves on psychiatry’s history, and equip ourselves with knowledge and tools to promote antiracism and shape psychiatry’s future. We can then apply these very tools to challenging situations we may encounter daily with the ultimate goal of improving the mental health of our patients. This is the only way we will progress and ensure that psychiatry is an equitable, antiracist field. As Ibram X. Kendi, PhD, has written, “The heartbeat of antiracism is self-reflection, recognition, admission, and fundamentally self-critique.”
Dr. Malik is a second-year psychiatry resident at the University of California, San Diego. She has a background in policy and grassroots organizing through her time working at the National Coalition for the Homeless and the Women’s Law Project. Dr. Malik has no disclosures.
References
1. Wyse R et al. Acad Psychiatry. 2020 Oct;44(5):523-30.
2. Cooper LA et al. Ann Intern Med. 2003;139:907-15.
3. Pierre JM et al. Acad Psychiatry. 2017;41:226-32.
4. Hartocollis A. “Getting into med school without hard sciences.” New York Times. 2010 Jul 29.
5. AAMC. An updated look at the economic diversity of U.S. medical students. Analysis in Brief. 2018 Oct;18(5).
6. Rainey ML. How do we retain minority health professions students. In: Smedley BD et al. The right thing to do, the smart thing to do: Enhancing diversity in the health professions: Summary of the Symposium on Diversity in Health Professions in Honor of Herbert W. Nickens, M.D. Institute of Medicine. National Academies Press. 2001.
7. Geller J. “Structural racism in American psychiatry and APA: Part 1.” Psychiatric News. 2020 Jun 23.
8. Mohr CL and Gordon JE. Tulane: The emergence of a modern university, 1945-1980. Louisiana State University Press, Baton Rouge. 2001.
9. Metzl JM. The protest psychosis: How schizophrenia became a Black disease. Beacon Press. 2010.
10. APA’s apology to Black, indigenous and people of color for its support of structural racism in psychiatry. American Psychiatric Association. 2021 Jan 18.
11. Black pioneers in mental health. Mental Health America. 2021.
12. Belli B. For Yale’s emerging psychiatrists, confronting racism is in the curriculum. Yale News. 2020 Jul 30.
13. Jordan A and Jackson D. Social justice and health equity curriculum. Yale School of Medicine. 2019 Sep 24.