Perspectives

Whenever Don McLean is asked what the lyrics to his iconic song “American Pie” mean, he answers: “They mean that I don’t have to work anymore.”

It would be nice if those of us who have never written an enigmatic hit tune could receive an unequivocal signal when it’s safe to retire. Unfortunately, the road to retirement is fraught with challenges, not least of which is locating the right off-ramp.

We tend to live longer than planned, so we run the risk of outliving our savings, which are often underfunded to begin with. And we don’t face facts about end-of-life care. Few of us have long-term care insurance, or the means to self-fund an extended long-term care situation, as I will discuss next month.

Many of us lack a clear idea of where our retirement income will come from, or if it will be there when we arrive. Doctors in particular are notorious for mismanaging their investments. Many try to self-manage retirement plans and personal savings without adequate time or knowledge to do it right. Involving a qualified financial professional is usually a far better strategy than going it alone.

So, assuming you have a solid savings plan, and solid help with its management – how will you know when you can safely retire? As with everything else, it depends; but to arrive at any sort of reliable ballpark figure, you’ll need to know three things: how much you realistically expect to spend annually after retirement; how much principal will throw off that amount in interest and dividends each year; and how far your present savings are from that target.

An oft-quoted rule of thumb is that, in retirement, your expenses will be about 70% of what they are now. In my opinion, that’s nonsense. While a few bills, such as disability and malpractice insurance premiums, will go away, other costs, such as recreation and medical care, will increase. I suggest assuming that your spending will not diminish significantly in retirement. Those of us who love travel or fancy toys may need even more.

Once you have an estimate of your annual retirement expenses, you’ll need to determine how much principal you’ll need – usually in fixed pensions and invested assets – to generate that income. Most financial advisors use the 5% rule: Assume your nest egg will pay you a conservative 5% of its value each year in dividends and interest. That rule has worked well, on average, over the long term. So if you estimate your postretirement spending will be around $100,000 per year (in today’s dollars), you’ll need about $2 million in assets. For $200,000 annual spending, you’ll need $4 million. (Should you factor in Social Security? Yes, if you’re 50 years or older; if you’re younger, I wouldn’t count on receiving any entitlements, and be pleasantly surprised if you do.)

How do you accumulate that kind of money? Financial experts say too many physicians invest too aggressively. For retirement, safety is the key. The most foolproof strategy – seldom employed, because it’s boring – is to sock away a fixed amount per month (after your retirement plan has been funded) in a mutual fund. $1,000 per month for 25 years with the market earning 10% (its historic long-term average) comes to almost $2 million, with the power of compounded interest working for you. And the earlier you start, the better.

It is never too soon to think about retirement. Young physicians often defer contributing to their retirement plans because they want to save for a new house or for college for their children. But there are tangible tax benefits that you get now, because your contributions usually reduce your taxable income, and your funds grow tax free until you withdraw them, presumably in a lower tax bracket.

At any age, it’s hard to motivate yourself to save, because it generally requires spending less money now. The way I do it is to pay myself first; that is, each month I make my regular savings contribution before considering any new purchases.

In the end, the strategy is very straightforward: Fill your retirement plan to its legal limit and let it grow, tax deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start, the better.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Whenever Don McLean is asked what the lyrics to his iconic song “American Pie” mean, he answers: “They mean that I don’t have to work anymore.”

It would be nice if those of us who have never written an enigmatic hit tune could receive an unequivocal signal when it’s safe to retire. Unfortunately, the road to retirement is fraught with challenges, not least of which is locating the right off-ramp.

We tend to live longer than planned, so we run the risk of outliving our savings, which are often underfunded to begin with. And we don’t face facts about end-of-life care. Few of us have long-term care insurance, or the means to self-fund an extended long-term care situation, as I will discuss next month.

Many of us lack a clear idea of where our retirement income will come from, or if it will be there when we arrive. Doctors in particular are notorious for mismanaging their investments. Many try to self-manage retirement plans and personal savings without adequate time or knowledge to do it right. Involving a qualified financial professional is usually a far better strategy than going it alone.

So, assuming you have a solid savings plan, and solid help with its management – how will you know when you can safely retire? As with everything else, it depends; but to arrive at any sort of reliable ballpark figure, you’ll need to know three things: how much you realistically expect to spend annually after retirement; how much principal will throw off that amount in interest and dividends each year; and how far your present savings are from that target.

An oft-quoted rule of thumb is that, in retirement, your expenses will be about 70% of what they are now. In my opinion, that’s nonsense. While a few bills, such as disability and malpractice insurance premiums, will go away, other costs, such as recreation and medical care, will increase. I suggest assuming that your spending will not diminish significantly in retirement. Those of us who love travel or fancy toys may need even more.

Once you have an estimate of your annual retirement expenses, you’ll need to determine how much principal you’ll need – usually in fixed pensions and invested assets – to generate that income. Most financial advisors use the 5% rule: Assume your nest egg will pay you a conservative 5% of its value each year in dividends and interest. That rule has worked well, on average, over the long term. So if you estimate your postretirement spending will be around $100,000 per year (in today’s dollars), you’ll need about $2 million in assets. For $200,000 annual spending, you’ll need $4 million. (Should you factor in Social Security? Yes, if you’re 50 years or older; if you’re younger, I wouldn’t count on receiving any entitlements, and be pleasantly surprised if you do.)

How do you accumulate that kind of money? Financial experts say too many physicians invest too aggressively. For retirement, safety is the key. The most foolproof strategy – seldom employed, because it’s boring – is to sock away a fixed amount per month (after your retirement plan has been funded) in a mutual fund. $1,000 per month for 25 years with the market earning 10% (its historic long-term average) comes to almost $2 million, with the power of compounded interest working for you. And the earlier you start, the better.

It is never too soon to think about retirement. Young physicians often defer contributing to their retirement plans because they want to save for a new house or for college for their children. But there are tangible tax benefits that you get now, because your contributions usually reduce your taxable income, and your funds grow tax free until you withdraw them, presumably in a lower tax bracket.

At any age, it’s hard to motivate yourself to save, because it generally requires spending less money now. The way I do it is to pay myself first; that is, each month I make my regular savings contribution before considering any new purchases.

In the end, the strategy is very straightforward: Fill your retirement plan to its legal limit and let it grow, tax deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start, the better.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Whenever Don McLean is asked what the lyrics to his iconic song “American Pie” mean, he answers: “They mean that I don’t have to work anymore.”

It would be nice if those of us who have never written an enigmatic hit tune could receive an unequivocal signal when it’s safe to retire. Unfortunately, the road to retirement is fraught with challenges, not least of which is locating the right off-ramp.

We tend to live longer than planned, so we run the risk of outliving our savings, which are often underfunded to begin with. And we don’t face facts about end-of-life care. Few of us have long-term care insurance, or the means to self-fund an extended long-term care situation, as I will discuss next month.

Many of us lack a clear idea of where our retirement income will come from, or if it will be there when we arrive. Doctors in particular are notorious for mismanaging their investments. Many try to self-manage retirement plans and personal savings without adequate time or knowledge to do it right. Involving a qualified financial professional is usually a far better strategy than going it alone.

So, assuming you have a solid savings plan, and solid help with its management – how will you know when you can safely retire? As with everything else, it depends; but to arrive at any sort of reliable ballpark figure, you’ll need to know three things: how much you realistically expect to spend annually after retirement; how much principal will throw off that amount in interest and dividends each year; and how far your present savings are from that target.

An oft-quoted rule of thumb is that, in retirement, your expenses will be about 70% of what they are now. In my opinion, that’s nonsense. While a few bills, such as disability and malpractice insurance premiums, will go away, other costs, such as recreation and medical care, will increase. I suggest assuming that your spending will not diminish significantly in retirement. Those of us who love travel or fancy toys may need even more.

Once you have an estimate of your annual retirement expenses, you’ll need to determine how much principal you’ll need – usually in fixed pensions and invested assets – to generate that income. Most financial advisors use the 5% rule: Assume your nest egg will pay you a conservative 5% of its value each year in dividends and interest. That rule has worked well, on average, over the long term. So if you estimate your postretirement spending will be around $100,000 per year (in today’s dollars), you’ll need about $2 million in assets. For $200,000 annual spending, you’ll need $4 million. (Should you factor in Social Security? Yes, if you’re 50 years or older; if you’re younger, I wouldn’t count on receiving any entitlements, and be pleasantly surprised if you do.)

How do you accumulate that kind of money? Financial experts say too many physicians invest too aggressively. For retirement, safety is the key. The most foolproof strategy – seldom employed, because it’s boring – is to sock away a fixed amount per month (after your retirement plan has been funded) in a mutual fund. $1,000 per month for 25 years with the market earning 10% (its historic long-term average) comes to almost $2 million, with the power of compounded interest working for you. And the earlier you start, the better.

It is never too soon to think about retirement. Young physicians often defer contributing to their retirement plans because they want to save for a new house or for college for their children. But there are tangible tax benefits that you get now, because your contributions usually reduce your taxable income, and your funds grow tax free until you withdraw them, presumably in a lower tax bracket.

At any age, it’s hard to motivate yourself to save, because it generally requires spending less money now. The way I do it is to pay myself first; that is, each month I make my regular savings contribution before considering any new purchases.

In the end, the strategy is very straightforward: Fill your retirement plan to its legal limit and let it grow, tax deferred. Then invest for the long term, with your target amount in mind. And once again, the earlier you start, the better.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Pregnancy-related mental health conditions are the most common complication of pregnancy, yet half of all women suffering will not be treated.

I wanted to address the stigma associated with these conditions as well as the rampant misinformation online. So, I reached out to Jen Schwartz, patient advocate and founder of Motherhood Understand, an online community for moms impacted by maternal mental health conditions. Together, we conceived the idea for the #MomsNeedToKnow maternal mental health awareness campaign, which will run from Oct. 14 to 25. This is an evidence-based campaign, complete with references and citations, that speaks to patients where they are at, i.e., social media.

With my clinical expertise and Jen’s reach, we felt like it was a natural partnership, as well as an innovative approach to empowering women to take control of their mental health during the perinatal period. We teamed up with Jamina Bone, an illustrator, and developed 2 weeks of Instagram posts, focused on the themes of lesser-known diagnoses, maternal mental health myths, and treatment options. This campaign is designed to help women understand risk factors for perinatal mood and anxiety disorders, as well as the signs of these conditions. It will cover lesser-known diagnoses like postpartum obsessive-compulsive disorder and posttraumatic stress disorder, and will address topics such as the impact of infertility on mental health and clarify the roles of different clinicians who can help.

Moreover, the campaign aims to address stigma and myths around psychiatric treatment during pregnancy – and also provides resources.

Dr. Lakshmin, a perinatal psychiatrist, is clinical assistant professor of psychiatry at George Washington University in Washington.

This article was updated 10/12/19.

Pregnancy-related mental health conditions are the most common complication of pregnancy, yet half of all women suffering will not be treated.

I wanted to address the stigma associated with these conditions as well as the rampant misinformation online. So, I reached out to Jen Schwartz, patient advocate and founder of Motherhood Understand, an online community for moms impacted by maternal mental health conditions. Together, we conceived the idea for the #MomsNeedToKnow maternal mental health awareness campaign, which will run from Oct. 14 to 25. This is an evidence-based campaign, complete with references and citations, that speaks to patients where they are at, i.e., social media.

With my clinical expertise and Jen’s reach, we felt like it was a natural partnership, as well as an innovative approach to empowering women to take control of their mental health during the perinatal period. We teamed up with Jamina Bone, an illustrator, and developed 2 weeks of Instagram posts, focused on the themes of lesser-known diagnoses, maternal mental health myths, and treatment options. This campaign is designed to help women understand risk factors for perinatal mood and anxiety disorders, as well as the signs of these conditions. It will cover lesser-known diagnoses like postpartum obsessive-compulsive disorder and posttraumatic stress disorder, and will address topics such as the impact of infertility on mental health and clarify the roles of different clinicians who can help.

Moreover, the campaign aims to address stigma and myths around psychiatric treatment during pregnancy – and also provides resources.

Dr. Lakshmin, a perinatal psychiatrist, is clinical assistant professor of psychiatry at George Washington University in Washington.

This article was updated 10/12/19.

Pregnancy-related mental health conditions are the most common complication of pregnancy, yet half of all women suffering will not be treated.

I wanted to address the stigma associated with these conditions as well as the rampant misinformation online. So, I reached out to Jen Schwartz, patient advocate and founder of Motherhood Understand, an online community for moms impacted by maternal mental health conditions. Together, we conceived the idea for the #MomsNeedToKnow maternal mental health awareness campaign, which will run from Oct. 14 to 25. This is an evidence-based campaign, complete with references and citations, that speaks to patients where they are at, i.e., social media.

With my clinical expertise and Jen’s reach, we felt like it was a natural partnership, as well as an innovative approach to empowering women to take control of their mental health during the perinatal period. We teamed up with Jamina Bone, an illustrator, and developed 2 weeks of Instagram posts, focused on the themes of lesser-known diagnoses, maternal mental health myths, and treatment options. This campaign is designed to help women understand risk factors for perinatal mood and anxiety disorders, as well as the signs of these conditions. It will cover lesser-known diagnoses like postpartum obsessive-compulsive disorder and posttraumatic stress disorder, and will address topics such as the impact of infertility on mental health and clarify the roles of different clinicians who can help.

Moreover, the campaign aims to address stigma and myths around psychiatric treatment during pregnancy – and also provides resources.

Dr. Lakshmin, a perinatal psychiatrist, is clinical assistant professor of psychiatry at George Washington University in Washington.

This article was updated 10/12/19.

In this edition of “How I will treat my next patient,” I focus on a recent presentation at the American Society for Radiation Oncology meeting regarding the association of recent closures in women’s health clinics with cervical cancer outcomes and on a publication regarding guideline-concordant radiation exposure and organizational characteristics of lung cancer screening programs.

Cervical cancer screening and outcomes

Between 2010 and 2013, nearly 100 women’s health clinics closed in the United States because of a variety of factors, including concerns by state legislatures about reproductive services. Amar J. Srivastava, MD, and colleagues, performed a database search to determine the effect of closures on cervical cancer screening, stage, and mortality (ASTRO 2019, Abstract 202). The researchers used the Behavioral Risk Factors Surveillance Study, which provided data from 197,143 cases, to assess differences in screening availability in 2008-2009 (before the closures). They used the Surveillance, Epidemiology, and End Results (SEER) registry data from 2014-2015 (after) on 10,652 patients to compare stage at diagnosis and disease-specific mortality in states with women’s health clinic closures and states without closures.

They found that the cervical cancer screening rate in states that had a decline in the number of women’s health clinics was 1.63% lower than in states that did not lose clinics. The disparity was greater in medically underserved subgroups: Hispanic women, women aged 21-34 years, unmarried women, and uninsured women.

Early-stage diagnosis was also significantly less common in states that had a decreased number of women’s health clinics – a 13.2% drop – and the overall mortality rate from cervical cancer was 36% higher. The difference was even higher (40%) when comparing only metro residents. All of these differences between states with and without closures were statistically significant.

How these results influence clinical practice

The law of unintended consequences is that the actions of people, and especially of governments, will have effects that are unanticipated or unintended. All oncologists understand this law – we live it every day.

The data generated by Dr. Srivastava and colleagues bring to mind two presentations at the 2019 annual meeting of the American Society of Clinical Oncology: the impact of Medicaid Expansion on racial disparities in time to cancer treatment (LBA 1) and the impact of the Affordable Care Act on early-stage diagnosis and treatment for women with ovarian cancer (LBA 5563). Collectively, they remind us that health care policy changes influence the timeliness of cancer care delivery and disparities in cancer care. Of course, these analyses describe associations, not necessarily causation. Large databases have quality and completeness limitations. Nonetheless, these abstracts and the associated presentations and discussions support the concept that improved access can be associated with improved cancer care outcomes.

In 1936, American sociologist Robert K. Merton described “imperious immediacy of interest,” referring to instances in which an individual wants the intended consequence of an action so badly that he or she purposefully chooses to ignore unintended effects. As a clinical and research community, we are obliged to highlight those effects when they influence our patients’ suffering.
 

Lung cancer screening

As a component of the Centers for Medicare & Medicaid Services’ requirements for lung cancer screening payment, institutions performing screening must use low-dose techniques and participate in a dose registry. The American College of Radiology (ACR) recommends the dose levels per CT slice (CTDIvol; 3 mGy or lower) and the effective dose (ED; 1 mSr or lower) that would qualify an examination as “low dose,” thereby hoping to minimize the risk of radiation-induced cancers.

Joshua Demb, PhD, and colleagues prospectively collected lung cancer screening examination dose metrics at U.S. institutions in the University of California, San Francisco, International Dose Registry (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3893). Only U.S. institutions that performed more than 24 lung cancer screening scans from 2016-2017 were included in the survey (n = 72, more than 12,500 patients). Institution-level factors were collected via the Partnership for Dose trial, including how CT scans are performed and how CT protocols are established at the institutional level.

In a data-dense analysis, the authors found that 65% of institutions delivered, and more than half of patients received, radiation doses above ACR targets. This suggests that both the potential screening benefits and the margins of benefits over risks might be reduced for patients at those institutions. Factors associated with exceeding ACR guidelines for radiation dose were using an “external” medical physicist, although having a medical physicist of any type was more beneficial than not having one; allowing any radiologist to establish or modify the screening protocol, instead of limiting that role to “lead” radiologists; and updating CT protocols as needed, compared with updating the protocols annually.

How these results influence clinical practice

As with the ASTRO 2019 presentation, the law of unintended consequences applies here. Whenever potentially healthy people are subjected to medical procedures to prevent illness or detect disease at early stages, protecting safety is paramount. For that reason, National Comprehensive Cancer Network (NCCN) guidelines are explicit that all lung cancer screening and follow-up scans should use low-dose techniques, unless evaluating mediastinal abnormalities or adenopathy.

The study by Dr. Demb and colleagues critically examined the proportion of lung cancer screening participants receiving guideline-concordant, low-dose examinations and several factors that could influence conformance with ACR guidelines. The results are instructive despite some of the study’s limits including the fact that the database used did not enable long-term follow-up of screened individuals for lung cancer detection or mortality, the survey relied on self-reporting, and the institutional level data was not solely focused on lung cancer screening examinations.

The survey reminds us that the logistics, quality control, and periodic review of well-intentioned programs like lung cancer screening require the thoughtful, regular involvement of teams of professionals who are cognizant of, adherent to, and vigilant about the guidelines that protect the individuals who entrust their care to us.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I will treat my next patient,” I focus on a recent presentation at the American Society for Radiation Oncology meeting regarding the association of recent closures in women’s health clinics with cervical cancer outcomes and on a publication regarding guideline-concordant radiation exposure and organizational characteristics of lung cancer screening programs.

Cervical cancer screening and outcomes

Between 2010 and 2013, nearly 100 women’s health clinics closed in the United States because of a variety of factors, including concerns by state legislatures about reproductive services. Amar J. Srivastava, MD, and colleagues, performed a database search to determine the effect of closures on cervical cancer screening, stage, and mortality (ASTRO 2019, Abstract 202). The researchers used the Behavioral Risk Factors Surveillance Study, which provided data from 197,143 cases, to assess differences in screening availability in 2008-2009 (before the closures). They used the Surveillance, Epidemiology, and End Results (SEER) registry data from 2014-2015 (after) on 10,652 patients to compare stage at diagnosis and disease-specific mortality in states with women’s health clinic closures and states without closures.

They found that the cervical cancer screening rate in states that had a decline in the number of women’s health clinics was 1.63% lower than in states that did not lose clinics. The disparity was greater in medically underserved subgroups: Hispanic women, women aged 21-34 years, unmarried women, and uninsured women.

Early-stage diagnosis was also significantly less common in states that had a decreased number of women’s health clinics – a 13.2% drop – and the overall mortality rate from cervical cancer was 36% higher. The difference was even higher (40%) when comparing only metro residents. All of these differences between states with and without closures were statistically significant.

How these results influence clinical practice

The law of unintended consequences is that the actions of people, and especially of governments, will have effects that are unanticipated or unintended. All oncologists understand this law – we live it every day.

The data generated by Dr. Srivastava and colleagues bring to mind two presentations at the 2019 annual meeting of the American Society of Clinical Oncology: the impact of Medicaid Expansion on racial disparities in time to cancer treatment (LBA 1) and the impact of the Affordable Care Act on early-stage diagnosis and treatment for women with ovarian cancer (LBA 5563). Collectively, they remind us that health care policy changes influence the timeliness of cancer care delivery and disparities in cancer care. Of course, these analyses describe associations, not necessarily causation. Large databases have quality and completeness limitations. Nonetheless, these abstracts and the associated presentations and discussions support the concept that improved access can be associated with improved cancer care outcomes.

In 1936, American sociologist Robert K. Merton described “imperious immediacy of interest,” referring to instances in which an individual wants the intended consequence of an action so badly that he or she purposefully chooses to ignore unintended effects. As a clinical and research community, we are obliged to highlight those effects when they influence our patients’ suffering.
 

Lung cancer screening

As a component of the Centers for Medicare & Medicaid Services’ requirements for lung cancer screening payment, institutions performing screening must use low-dose techniques and participate in a dose registry. The American College of Radiology (ACR) recommends the dose levels per CT slice (CTDIvol; 3 mGy or lower) and the effective dose (ED; 1 mSr or lower) that would qualify an examination as “low dose,” thereby hoping to minimize the risk of radiation-induced cancers.

Joshua Demb, PhD, and colleagues prospectively collected lung cancer screening examination dose metrics at U.S. institutions in the University of California, San Francisco, International Dose Registry (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3893). Only U.S. institutions that performed more than 24 lung cancer screening scans from 2016-2017 were included in the survey (n = 72, more than 12,500 patients). Institution-level factors were collected via the Partnership for Dose trial, including how CT scans are performed and how CT protocols are established at the institutional level.

In a data-dense analysis, the authors found that 65% of institutions delivered, and more than half of patients received, radiation doses above ACR targets. This suggests that both the potential screening benefits and the margins of benefits over risks might be reduced for patients at those institutions. Factors associated with exceeding ACR guidelines for radiation dose were using an “external” medical physicist, although having a medical physicist of any type was more beneficial than not having one; allowing any radiologist to establish or modify the screening protocol, instead of limiting that role to “lead” radiologists; and updating CT protocols as needed, compared with updating the protocols annually.

How these results influence clinical practice

As with the ASTRO 2019 presentation, the law of unintended consequences applies here. Whenever potentially healthy people are subjected to medical procedures to prevent illness or detect disease at early stages, protecting safety is paramount. For that reason, National Comprehensive Cancer Network (NCCN) guidelines are explicit that all lung cancer screening and follow-up scans should use low-dose techniques, unless evaluating mediastinal abnormalities or adenopathy.

The study by Dr. Demb and colleagues critically examined the proportion of lung cancer screening participants receiving guideline-concordant, low-dose examinations and several factors that could influence conformance with ACR guidelines. The results are instructive despite some of the study’s limits including the fact that the database used did not enable long-term follow-up of screened individuals for lung cancer detection or mortality, the survey relied on self-reporting, and the institutional level data was not solely focused on lung cancer screening examinations.

The survey reminds us that the logistics, quality control, and periodic review of well-intentioned programs like lung cancer screening require the thoughtful, regular involvement of teams of professionals who are cognizant of, adherent to, and vigilant about the guidelines that protect the individuals who entrust their care to us.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I will treat my next patient,” I focus on a recent presentation at the American Society for Radiation Oncology meeting regarding the association of recent closures in women’s health clinics with cervical cancer outcomes and on a publication regarding guideline-concordant radiation exposure and organizational characteristics of lung cancer screening programs.

Cervical cancer screening and outcomes

Between 2010 and 2013, nearly 100 women’s health clinics closed in the United States because of a variety of factors, including concerns by state legislatures about reproductive services. Amar J. Srivastava, MD, and colleagues, performed a database search to determine the effect of closures on cervical cancer screening, stage, and mortality (ASTRO 2019, Abstract 202). The researchers used the Behavioral Risk Factors Surveillance Study, which provided data from 197,143 cases, to assess differences in screening availability in 2008-2009 (before the closures). They used the Surveillance, Epidemiology, and End Results (SEER) registry data from 2014-2015 (after) on 10,652 patients to compare stage at diagnosis and disease-specific mortality in states with women’s health clinic closures and states without closures.

They found that the cervical cancer screening rate in states that had a decline in the number of women’s health clinics was 1.63% lower than in states that did not lose clinics. The disparity was greater in medically underserved subgroups: Hispanic women, women aged 21-34 years, unmarried women, and uninsured women.

Early-stage diagnosis was also significantly less common in states that had a decreased number of women’s health clinics – a 13.2% drop – and the overall mortality rate from cervical cancer was 36% higher. The difference was even higher (40%) when comparing only metro residents. All of these differences between states with and without closures were statistically significant.

How these results influence clinical practice

The law of unintended consequences is that the actions of people, and especially of governments, will have effects that are unanticipated or unintended. All oncologists understand this law – we live it every day.

The data generated by Dr. Srivastava and colleagues bring to mind two presentations at the 2019 annual meeting of the American Society of Clinical Oncology: the impact of Medicaid Expansion on racial disparities in time to cancer treatment (LBA 1) and the impact of the Affordable Care Act on early-stage diagnosis and treatment for women with ovarian cancer (LBA 5563). Collectively, they remind us that health care policy changes influence the timeliness of cancer care delivery and disparities in cancer care. Of course, these analyses describe associations, not necessarily causation. Large databases have quality and completeness limitations. Nonetheless, these abstracts and the associated presentations and discussions support the concept that improved access can be associated with improved cancer care outcomes.

In 1936, American sociologist Robert K. Merton described “imperious immediacy of interest,” referring to instances in which an individual wants the intended consequence of an action so badly that he or she purposefully chooses to ignore unintended effects. As a clinical and research community, we are obliged to highlight those effects when they influence our patients’ suffering.
 

Lung cancer screening

As a component of the Centers for Medicare & Medicaid Services’ requirements for lung cancer screening payment, institutions performing screening must use low-dose techniques and participate in a dose registry. The American College of Radiology (ACR) recommends the dose levels per CT slice (CTDIvol; 3 mGy or lower) and the effective dose (ED; 1 mSr or lower) that would qualify an examination as “low dose,” thereby hoping to minimize the risk of radiation-induced cancers.

Joshua Demb, PhD, and colleagues prospectively collected lung cancer screening examination dose metrics at U.S. institutions in the University of California, San Francisco, International Dose Registry (JAMA Intern Med. 2019 Sep 23. doi: 10.1001/jamainternmed.2019.3893). Only U.S. institutions that performed more than 24 lung cancer screening scans from 2016-2017 were included in the survey (n = 72, more than 12,500 patients). Institution-level factors were collected via the Partnership for Dose trial, including how CT scans are performed and how CT protocols are established at the institutional level.

In a data-dense analysis, the authors found that 65% of institutions delivered, and more than half of patients received, radiation doses above ACR targets. This suggests that both the potential screening benefits and the margins of benefits over risks might be reduced for patients at those institutions. Factors associated with exceeding ACR guidelines for radiation dose were using an “external” medical physicist, although having a medical physicist of any type was more beneficial than not having one; allowing any radiologist to establish or modify the screening protocol, instead of limiting that role to “lead” radiologists; and updating CT protocols as needed, compared with updating the protocols annually.

How these results influence clinical practice

As with the ASTRO 2019 presentation, the law of unintended consequences applies here. Whenever potentially healthy people are subjected to medical procedures to prevent illness or detect disease at early stages, protecting safety is paramount. For that reason, National Comprehensive Cancer Network (NCCN) guidelines are explicit that all lung cancer screening and follow-up scans should use low-dose techniques, unless evaluating mediastinal abnormalities or adenopathy.

The study by Dr. Demb and colleagues critically examined the proportion of lung cancer screening participants receiving guideline-concordant, low-dose examinations and several factors that could influence conformance with ACR guidelines. The results are instructive despite some of the study’s limits including the fact that the database used did not enable long-term follow-up of screened individuals for lung cancer detection or mortality, the survey relied on self-reporting, and the institutional level data was not solely focused on lung cancer screening examinations.

The survey reminds us that the logistics, quality control, and periodic review of well-intentioned programs like lung cancer screening require the thoughtful, regular involvement of teams of professionals who are cognizant of, adherent to, and vigilant about the guidelines that protect the individuals who entrust their care to us.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

Another solo-practice neurologist and I were talking last week. He’s understandably worried about the local hospital starting construction on a new “neuroscience center” down the street from us. They have ambitious plans for it, which apparently don’t include those of us who’ve served the community for 20-30 years.

Whatever. I’ve been in a large practice before, and don’t want to be a part of one again.

His concern, which I have, too, is that the hospital center will drive us little guys out of business. This seems to be a common medical practice model these days.

I hope not. I’ve been doing this for a long time, and am happy with my little world. I also believe, perhaps naively, that there’s still a place for a small practice.

My staff and I know my patients. We’re generally tuned in to who needs what, or how much time. We return all calls within a few hours (or less) and try be on top of getting medication refills and records requests done the same day they come in.

While a large practice has some advantages, based on my time with one I’d have to say we didn’t do those things as well there. Messages often weren’t relayed, or were sent to the wrong doctor. Here there’s only me.

I may not make as much, but my appointment times and intervals aren’t dictated by an accountant. This allows me to generally spend as much time as needed with each person and not feel rushed as the day goes on. I hope patients still desire that in a physician, as opposed to a place advertising “20 neurologists, no waiting!” on a sign that would fit in on the Vegas strip.

Obviously, I can’t control what the hospital will do. I can only manage my own little world. I’ll continue doing that as best I can, as long as I’m able.

Time spent worrying about things I can’t change isn’t productive and is bad for one’s blood pressure. So I’ll focus on what I can do, and try not to worry about the rest.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Another solo-practice neurologist and I were talking last week. He’s understandably worried about the local hospital starting construction on a new “neuroscience center” down the street from us. They have ambitious plans for it, which apparently don’t include those of us who’ve served the community for 20-30 years.

Whatever. I’ve been in a large practice before, and don’t want to be a part of one again.

His concern, which I have, too, is that the hospital center will drive us little guys out of business. This seems to be a common medical practice model these days.

I hope not. I’ve been doing this for a long time, and am happy with my little world. I also believe, perhaps naively, that there’s still a place for a small practice.

My staff and I know my patients. We’re generally tuned in to who needs what, or how much time. We return all calls within a few hours (or less) and try be on top of getting medication refills and records requests done the same day they come in.

While a large practice has some advantages, based on my time with one I’d have to say we didn’t do those things as well there. Messages often weren’t relayed, or were sent to the wrong doctor. Here there’s only me.

I may not make as much, but my appointment times and intervals aren’t dictated by an accountant. This allows me to generally spend as much time as needed with each person and not feel rushed as the day goes on. I hope patients still desire that in a physician, as opposed to a place advertising “20 neurologists, no waiting!” on a sign that would fit in on the Vegas strip.

Obviously, I can’t control what the hospital will do. I can only manage my own little world. I’ll continue doing that as best I can, as long as I’m able.

Time spent worrying about things I can’t change isn’t productive and is bad for one’s blood pressure. So I’ll focus on what I can do, and try not to worry about the rest.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Another solo-practice neurologist and I were talking last week. He’s understandably worried about the local hospital starting construction on a new “neuroscience center” down the street from us. They have ambitious plans for it, which apparently don’t include those of us who’ve served the community for 20-30 years.

Whatever. I’ve been in a large practice before, and don’t want to be a part of one again.

His concern, which I have, too, is that the hospital center will drive us little guys out of business. This seems to be a common medical practice model these days.

I hope not. I’ve been doing this for a long time, and am happy with my little world. I also believe, perhaps naively, that there’s still a place for a small practice.

My staff and I know my patients. We’re generally tuned in to who needs what, or how much time. We return all calls within a few hours (or less) and try be on top of getting medication refills and records requests done the same day they come in.

While a large practice has some advantages, based on my time with one I’d have to say we didn’t do those things as well there. Messages often weren’t relayed, or were sent to the wrong doctor. Here there’s only me.

I may not make as much, but my appointment times and intervals aren’t dictated by an accountant. This allows me to generally spend as much time as needed with each person and not feel rushed as the day goes on. I hope patients still desire that in a physician, as opposed to a place advertising “20 neurologists, no waiting!” on a sign that would fit in on the Vegas strip.

Obviously, I can’t control what the hospital will do. I can only manage my own little world. I’ll continue doing that as best I can, as long as I’m able.

Time spent worrying about things I can’t change isn’t productive and is bad for one’s blood pressure. So I’ll focus on what I can do, and try not to worry about the rest.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

It’s 6:30 on a Friday night, and I am triaging three admissions to the leukemia service at once. The call from the ED about you makes me pause. I recognize your name – you were my patient a few years before. At the time, you were undergoing chemotherapy for acute myeloid leukemia, and I cared for you during the aftermath. I now pull up your chart and fill in the gaps of the last 2 years. You got into remission and received a bone marrow transplant. For 2 years, you were cured. But today, you are back. The ED has picked up an abundance of blasts – cancer cells – in your blood. I walk to your ED gurney slowly, thinking of how to tell you this. You recognize me, too. And I can see in your eyes that you already know. “I am so sorry this is happening,” I say.

You are here for your third cycle of chemotherapy. It’s a standard check-in. The first cycle was tolerable, the second cycle was rough, and now you are exhausted. You wonder if it’s normal to be so beat up from this. You ask how much nausea is too much nausea. But your hair didn’t fall out – isn’t that strange? Is it a sure thing that it will? And, by the way, is there anything to prevent the neuropathy? You wiggle your fingers as if to emphasize the point. We go through each of your symptoms and strategize ways to make this cycle better than the last. “OK,” you conclude triumphantly. “I got this!”

It’s your 1-month follow-up and it’s time to pivot. After you were diagnosed with an aggressive triple-negative breast cancer, you met with a medical oncologist and a surgeon. Chemotherapy first, they agreed. The chemo would shrink the tumor, they said, so that it could all be scooped out with surgery. The medications were rough, but you knew it was for the best. But now it’s been two cycles and the lump in your breast is getting bigger not smaller. I ask if I may draw on your skin, promising I’ll wash it off. I gently trace the mass in pen and pull out a tape measure. Yes. It is bigger. I listen to your heart and hear it racing. “What now?” you ask.

When you saw your doctor for bloating and were told it’s not gas, actually, but stage 4 cancer, you didn’t cry. You didn’t deny it. You prepared. You called your lawyer and made a will. You contacted your job and planned for retirement. You organized your things so your children wouldn’t have to. Your oncologist recommended palliative chemotherapy as it could give you some more good days. The best case scenario would be 1 year. That was 2½ years ago. You still like to be prepared, you tell me, but that’s on the back burner now. You are busy, after all – your feet still ache from dancing all night in heels at your niece’s wedding last weekend. I pull up your latest PET scan and we look together: Again, wonderfully, everything appears stable. “See you in 3 months,” I say.

You called three times to move up this appointment because you didn’t know if you’d be alive this long. You want a second opinion. When your kidney cancer grew after surgery, two immunotherapy drugs, and a chemotherapy pill, the latest setback has been fevers up to 104 ° with drenching night sweats. They found a deep infection gnawing around the edges of your tumor, and antibiotics aren’t touching it. The only chance to stop the cancer is more chemotherapy, but that could make the infection worse and lead to a rapid demise. You can’t decide. Today, in the exam room, you are sweating. Your temperature is 101 °. Your partner is trying to keep it together, but the crumpled tissues in her hand give it away. She looks at me earnestly: “What would you do if this were your family member?”

You teach about this disease in your classes and never thought it would happen to you. It started simply enough – you were bruising. Your joints ached. Small things; odd things. The ER doctor cleverly noticed that some numbers were off in your blood counts and sent you to a hematology-oncology doctor, who then cleverly ordered a molecular blood test. It was a long shot. He didn’t really expect it to come back with chronic myeloid leukemia. But there it is, and here we are. You return to talk about treatment options. You understand in detail the biology of how they work. What you don’t know is which is best for you. I go through the four choices and unpleasant effects of each. Muscle aches; diarrhea; risk of bleeding; twice a day dosing tied to mealtimes. “Is there an Option 5?” you wonder.

You have been in the hospital for 34 days, but who’s counting? You are. Because it has been Thirty. Four. Days. You knew the chemotherapy would suppress your blood counts. Now you know what “impaired immune system” really means. You had the bloodstream bacterial infection, requiring 2 days in the ICU. You had the invasive fungus growing in your lungs. The nurses post a calendar on your wall and kindly fill it in every day with your white blood cell count so you don’t have to ask. For days, it’s the same. Your bag stays packed – “just in case,” you explain. Your spouse diligently keeps your children – 2 and 4 years old – away, as kids are notorious germ factories. Then one Sunday morning and – finally! “Put me on speakerphone,” you tell your spouse. “Daddy is coming home!”

One of the most precious parts of hematology and oncology is the relationships. You are there not just for one difficult moment, but for the journey. I await getting to help you over the years to come. For now, I will settle for snapshots.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

It’s 6:30 on a Friday night, and I am triaging three admissions to the leukemia service at once. The call from the ED about you makes me pause. I recognize your name – you were my patient a few years before. At the time, you were undergoing chemotherapy for acute myeloid leukemia, and I cared for you during the aftermath. I now pull up your chart and fill in the gaps of the last 2 years. You got into remission and received a bone marrow transplant. For 2 years, you were cured. But today, you are back. The ED has picked up an abundance of blasts – cancer cells – in your blood. I walk to your ED gurney slowly, thinking of how to tell you this. You recognize me, too. And I can see in your eyes that you already know. “I am so sorry this is happening,” I say.

You are here for your third cycle of chemotherapy. It’s a standard check-in. The first cycle was tolerable, the second cycle was rough, and now you are exhausted. You wonder if it’s normal to be so beat up from this. You ask how much nausea is too much nausea. But your hair didn’t fall out – isn’t that strange? Is it a sure thing that it will? And, by the way, is there anything to prevent the neuropathy? You wiggle your fingers as if to emphasize the point. We go through each of your symptoms and strategize ways to make this cycle better than the last. “OK,” you conclude triumphantly. “I got this!”

It’s your 1-month follow-up and it’s time to pivot. After you were diagnosed with an aggressive triple-negative breast cancer, you met with a medical oncologist and a surgeon. Chemotherapy first, they agreed. The chemo would shrink the tumor, they said, so that it could all be scooped out with surgery. The medications were rough, but you knew it was for the best. But now it’s been two cycles and the lump in your breast is getting bigger not smaller. I ask if I may draw on your skin, promising I’ll wash it off. I gently trace the mass in pen and pull out a tape measure. Yes. It is bigger. I listen to your heart and hear it racing. “What now?” you ask.

When you saw your doctor for bloating and were told it’s not gas, actually, but stage 4 cancer, you didn’t cry. You didn’t deny it. You prepared. You called your lawyer and made a will. You contacted your job and planned for retirement. You organized your things so your children wouldn’t have to. Your oncologist recommended palliative chemotherapy as it could give you some more good days. The best case scenario would be 1 year. That was 2½ years ago. You still like to be prepared, you tell me, but that’s on the back burner now. You are busy, after all – your feet still ache from dancing all night in heels at your niece’s wedding last weekend. I pull up your latest PET scan and we look together: Again, wonderfully, everything appears stable. “See you in 3 months,” I say.

You called three times to move up this appointment because you didn’t know if you’d be alive this long. You want a second opinion. When your kidney cancer grew after surgery, two immunotherapy drugs, and a chemotherapy pill, the latest setback has been fevers up to 104 ° with drenching night sweats. They found a deep infection gnawing around the edges of your tumor, and antibiotics aren’t touching it. The only chance to stop the cancer is more chemotherapy, but that could make the infection worse and lead to a rapid demise. You can’t decide. Today, in the exam room, you are sweating. Your temperature is 101 °. Your partner is trying to keep it together, but the crumpled tissues in her hand give it away. She looks at me earnestly: “What would you do if this were your family member?”

You teach about this disease in your classes and never thought it would happen to you. It started simply enough – you were bruising. Your joints ached. Small things; odd things. The ER doctor cleverly noticed that some numbers were off in your blood counts and sent you to a hematology-oncology doctor, who then cleverly ordered a molecular blood test. It was a long shot. He didn’t really expect it to come back with chronic myeloid leukemia. But there it is, and here we are. You return to talk about treatment options. You understand in detail the biology of how they work. What you don’t know is which is best for you. I go through the four choices and unpleasant effects of each. Muscle aches; diarrhea; risk of bleeding; twice a day dosing tied to mealtimes. “Is there an Option 5?” you wonder.

You have been in the hospital for 34 days, but who’s counting? You are. Because it has been Thirty. Four. Days. You knew the chemotherapy would suppress your blood counts. Now you know what “impaired immune system” really means. You had the bloodstream bacterial infection, requiring 2 days in the ICU. You had the invasive fungus growing in your lungs. The nurses post a calendar on your wall and kindly fill it in every day with your white blood cell count so you don’t have to ask. For days, it’s the same. Your bag stays packed – “just in case,” you explain. Your spouse diligently keeps your children – 2 and 4 years old – away, as kids are notorious germ factories. Then one Sunday morning and – finally! “Put me on speakerphone,” you tell your spouse. “Daddy is coming home!”

One of the most precious parts of hematology and oncology is the relationships. You are there not just for one difficult moment, but for the journey. I await getting to help you over the years to come. For now, I will settle for snapshots.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

It’s 6:30 on a Friday night, and I am triaging three admissions to the leukemia service at once. The call from the ED about you makes me pause. I recognize your name – you were my patient a few years before. At the time, you were undergoing chemotherapy for acute myeloid leukemia, and I cared for you during the aftermath. I now pull up your chart and fill in the gaps of the last 2 years. You got into remission and received a bone marrow transplant. For 2 years, you were cured. But today, you are back. The ED has picked up an abundance of blasts – cancer cells – in your blood. I walk to your ED gurney slowly, thinking of how to tell you this. You recognize me, too. And I can see in your eyes that you already know. “I am so sorry this is happening,” I say.

You are here for your third cycle of chemotherapy. It’s a standard check-in. The first cycle was tolerable, the second cycle was rough, and now you are exhausted. You wonder if it’s normal to be so beat up from this. You ask how much nausea is too much nausea. But your hair didn’t fall out – isn’t that strange? Is it a sure thing that it will? And, by the way, is there anything to prevent the neuropathy? You wiggle your fingers as if to emphasize the point. We go through each of your symptoms and strategize ways to make this cycle better than the last. “OK,” you conclude triumphantly. “I got this!”

It’s your 1-month follow-up and it’s time to pivot. After you were diagnosed with an aggressive triple-negative breast cancer, you met with a medical oncologist and a surgeon. Chemotherapy first, they agreed. The chemo would shrink the tumor, they said, so that it could all be scooped out with surgery. The medications were rough, but you knew it was for the best. But now it’s been two cycles and the lump in your breast is getting bigger not smaller. I ask if I may draw on your skin, promising I’ll wash it off. I gently trace the mass in pen and pull out a tape measure. Yes. It is bigger. I listen to your heart and hear it racing. “What now?” you ask.

When you saw your doctor for bloating and were told it’s not gas, actually, but stage 4 cancer, you didn’t cry. You didn’t deny it. You prepared. You called your lawyer and made a will. You contacted your job and planned for retirement. You organized your things so your children wouldn’t have to. Your oncologist recommended palliative chemotherapy as it could give you some more good days. The best case scenario would be 1 year. That was 2½ years ago. You still like to be prepared, you tell me, but that’s on the back burner now. You are busy, after all – your feet still ache from dancing all night in heels at your niece’s wedding last weekend. I pull up your latest PET scan and we look together: Again, wonderfully, everything appears stable. “See you in 3 months,” I say.

You called three times to move up this appointment because you didn’t know if you’d be alive this long. You want a second opinion. When your kidney cancer grew after surgery, two immunotherapy drugs, and a chemotherapy pill, the latest setback has been fevers up to 104 ° with drenching night sweats. They found a deep infection gnawing around the edges of your tumor, and antibiotics aren’t touching it. The only chance to stop the cancer is more chemotherapy, but that could make the infection worse and lead to a rapid demise. You can’t decide. Today, in the exam room, you are sweating. Your temperature is 101 °. Your partner is trying to keep it together, but the crumpled tissues in her hand give it away. She looks at me earnestly: “What would you do if this were your family member?”

You teach about this disease in your classes and never thought it would happen to you. It started simply enough – you were bruising. Your joints ached. Small things; odd things. The ER doctor cleverly noticed that some numbers were off in your blood counts and sent you to a hematology-oncology doctor, who then cleverly ordered a molecular blood test. It was a long shot. He didn’t really expect it to come back with chronic myeloid leukemia. But there it is, and here we are. You return to talk about treatment options. You understand in detail the biology of how they work. What you don’t know is which is best for you. I go through the four choices and unpleasant effects of each. Muscle aches; diarrhea; risk of bleeding; twice a day dosing tied to mealtimes. “Is there an Option 5?” you wonder.

You have been in the hospital for 34 days, but who’s counting? You are. Because it has been Thirty. Four. Days. You knew the chemotherapy would suppress your blood counts. Now you know what “impaired immune system” really means. You had the bloodstream bacterial infection, requiring 2 days in the ICU. You had the invasive fungus growing in your lungs. The nurses post a calendar on your wall and kindly fill it in every day with your white blood cell count so you don’t have to ask. For days, it’s the same. Your bag stays packed – “just in case,” you explain. Your spouse diligently keeps your children – 2 and 4 years old – away, as kids are notorious germ factories. Then one Sunday morning and – finally! “Put me on speakerphone,” you tell your spouse. “Daddy is coming home!”

One of the most precious parts of hematology and oncology is the relationships. You are there not just for one difficult moment, but for the journey. I await getting to help you over the years to come. For now, I will settle for snapshots.
 

Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University. Follow her on Twitter @ilanayurkiewicz and listen to her each week on the Blood & Cancer podcast.

Skyrocketing drug costs are a key issue facing physicians, patients, and policymakers, but an even thornier problem may be determining a drug’s value.

In this Q&A, Richard L. Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology (ASCO), weighs in on the value proposition for cancer drugs and the implications for physicians.
 

Q: What tools exist for determining a drug’s value?

A: A number of organizations have developed tools to try to determine the value of cancer drug treatments. ASCO, the European Society for Medical Oncology (ESMO), the Institute for Clinical and Economic Review, Memorial Sloan Kettering Cancer Center, and the National Comprehensive Cancer Network have all developed tools for this purpose.

Our tool, the ASCO Value Framework, assesses the value of new cancer drug treatments based on clinical benefit, side effects, and improvements in patient symptoms or quality of life in the context of cost. While it’s hard to directly compare frameworks – given differences in methodology and the many nuances of evaluating clinical trial results – in 2018, ASCO and ESMO published a joint analysis of our value frameworks in the Journal of Clinical Oncology (2018; 37[4]:336-49).

The analysis found that the frameworks produce comparable measures of the clinical benefits of new therapies in approximately two-thirds of the more than 100 treatment comparisons that were examined. It also identified a number of factors that may contribute to the discordant scores, revealing potential ways for both of our organizations to refine our frameworks in the future.

That said, ASCO’s Value Framework is just one part of our broader, multifaceted effort to achieve high-quality, high-value care for all patients with cancer. Other efforts include ASCO’s proposed Patient-Centered Oncology Payment model, the Choosing Wisely campaign to identify low-value clinical strategies, and CancerLinQ and the Quality Oncology Practice Initiative to implement quality measurement and improvement.
 

Q: How can the issues around drug price and value be addressed earlier in the context of clinical trials?

A: The definition of value ultimately comes down to the price that must be paid to achieve meaningfully improved health outcomes for individual patients or the broader population of affected individuals. Optimizing the value of a new cancer drug treatment begins with an innovation to address an unmet medical need, followed by defining and achieving clinically meaningful improvements in health outcomes through well-designed and efficiently conducted clinical trials. Effectiveness research is also essential to determining how well new treatments perform compared with available alternatives and how they perform in more diverse populations than those typically included in the clinical trials used to establish efficacy.

Patient goals, preferences, and choices shape the real-world experience of a new product, and the direct and indirect costs of a treatment to patients and their families significantly affect whether it is adopted widely. Until their value is clearly established, new and costly products should be deployed judiciously and after careful consideration of the goals of treatment, available options, and the unique needs, preferences, and goals of individual patients.

More research is needed to improve how we assess the value of new cancer drug treatments. New clinical efficacy endpoints – both provider- and patient-reported ones – that accurately describe how a patient feels and functions must be developed and should reflect outcomes of value to patients other than survival, particularly in noncurative settings.

Better predictive biomarkers can transform a drug of modest efficacy in an unselected population to one of high efficacy in a biomarker-defined subgroup and thereby contribute to improving the value of a treatment.

Regulatory and policy initiatives such as adaptive licensing, value-based insurance, and indication-specific pricing that affect marketing approval, reimbursement, or price, respectively, based on treatment effectiveness, also deserve careful consideration and further research to determine their effects on aligning cost with benefit while ensuring patient access to potentially life-extending therapies and continued innovation in drug development.
 

Q: Aside from the policy options, what’s the role of the oncologist in discussing the value of drugs with patients when determining a treatment plan?

A: Since oncologists don’t control drug prices, our role in improving the value of cancer care involves appropriately managing how resources are used and guiding patients during discussions around the right treatment plan for their particular diagnosis, prognosis, and treatment goals.

Adopting and adhering to high-quality oncology clinical pathways is an important way to improve the quality, efficiency, and value of cancer care. High-quality oncology pathways are detailed, evidence-based treatment protocols for delivering cancer care to patients with specific disease types and stages. When properly designed and implemented, oncology pathways serve as an important tool in appropriately managing cancer care resources and improving the quality of care that patients with cancer receive, while also reducing costs.
 

Dr. Schilsky is the senior vice president and chief medical officer of ASCO. Formerly the chief of hematology/oncology in the department of medicine and deputy director of the University of Chicago Comprehensive Cancer Center, he is a leader in the field of clinical oncology, specializing in new drug development and the treatment of gastrointestinal cancers. Dr. Schilsky reported research funding from several pharmaceutical companies to ASCO for the Targeted Agent and Profiling Utilization Registry (TAPUR) clinical trial. He also reported travel/accommodation/expense support from Varian.

Skyrocketing drug costs are a key issue facing physicians, patients, and policymakers, but an even thornier problem may be determining a drug’s value.

In this Q&A, Richard L. Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology (ASCO), weighs in on the value proposition for cancer drugs and the implications for physicians.
 

Q: What tools exist for determining a drug’s value?

A: A number of organizations have developed tools to try to determine the value of cancer drug treatments. ASCO, the European Society for Medical Oncology (ESMO), the Institute for Clinical and Economic Review, Memorial Sloan Kettering Cancer Center, and the National Comprehensive Cancer Network have all developed tools for this purpose.

Our tool, the ASCO Value Framework, assesses the value of new cancer drug treatments based on clinical benefit, side effects, and improvements in patient symptoms or quality of life in the context of cost. While it’s hard to directly compare frameworks – given differences in methodology and the many nuances of evaluating clinical trial results – in 2018, ASCO and ESMO published a joint analysis of our value frameworks in the Journal of Clinical Oncology (2018; 37[4]:336-49).

The analysis found that the frameworks produce comparable measures of the clinical benefits of new therapies in approximately two-thirds of the more than 100 treatment comparisons that were examined. It also identified a number of factors that may contribute to the discordant scores, revealing potential ways for both of our organizations to refine our frameworks in the future.

That said, ASCO’s Value Framework is just one part of our broader, multifaceted effort to achieve high-quality, high-value care for all patients with cancer. Other efforts include ASCO’s proposed Patient-Centered Oncology Payment model, the Choosing Wisely campaign to identify low-value clinical strategies, and CancerLinQ and the Quality Oncology Practice Initiative to implement quality measurement and improvement.
 

Q: How can the issues around drug price and value be addressed earlier in the context of clinical trials?

A: The definition of value ultimately comes down to the price that must be paid to achieve meaningfully improved health outcomes for individual patients or the broader population of affected individuals. Optimizing the value of a new cancer drug treatment begins with an innovation to address an unmet medical need, followed by defining and achieving clinically meaningful improvements in health outcomes through well-designed and efficiently conducted clinical trials. Effectiveness research is also essential to determining how well new treatments perform compared with available alternatives and how they perform in more diverse populations than those typically included in the clinical trials used to establish efficacy.

Patient goals, preferences, and choices shape the real-world experience of a new product, and the direct and indirect costs of a treatment to patients and their families significantly affect whether it is adopted widely. Until their value is clearly established, new and costly products should be deployed judiciously and after careful consideration of the goals of treatment, available options, and the unique needs, preferences, and goals of individual patients.

More research is needed to improve how we assess the value of new cancer drug treatments. New clinical efficacy endpoints – both provider- and patient-reported ones – that accurately describe how a patient feels and functions must be developed and should reflect outcomes of value to patients other than survival, particularly in noncurative settings.

Better predictive biomarkers can transform a drug of modest efficacy in an unselected population to one of high efficacy in a biomarker-defined subgroup and thereby contribute to improving the value of a treatment.

Regulatory and policy initiatives such as adaptive licensing, value-based insurance, and indication-specific pricing that affect marketing approval, reimbursement, or price, respectively, based on treatment effectiveness, also deserve careful consideration and further research to determine their effects on aligning cost with benefit while ensuring patient access to potentially life-extending therapies and continued innovation in drug development.
 

Q: Aside from the policy options, what’s the role of the oncologist in discussing the value of drugs with patients when determining a treatment plan?

A: Since oncologists don’t control drug prices, our role in improving the value of cancer care involves appropriately managing how resources are used and guiding patients during discussions around the right treatment plan for their particular diagnosis, prognosis, and treatment goals.

Adopting and adhering to high-quality oncology clinical pathways is an important way to improve the quality, efficiency, and value of cancer care. High-quality oncology pathways are detailed, evidence-based treatment protocols for delivering cancer care to patients with specific disease types and stages. When properly designed and implemented, oncology pathways serve as an important tool in appropriately managing cancer care resources and improving the quality of care that patients with cancer receive, while also reducing costs.
 

Dr. Schilsky is the senior vice president and chief medical officer of ASCO. Formerly the chief of hematology/oncology in the department of medicine and deputy director of the University of Chicago Comprehensive Cancer Center, he is a leader in the field of clinical oncology, specializing in new drug development and the treatment of gastrointestinal cancers. Dr. Schilsky reported research funding from several pharmaceutical companies to ASCO for the Targeted Agent and Profiling Utilization Registry (TAPUR) clinical trial. He also reported travel/accommodation/expense support from Varian.

Skyrocketing drug costs are a key issue facing physicians, patients, and policymakers, but an even thornier problem may be determining a drug’s value.

In this Q&A, Richard L. Schilsky, MD, senior vice president and chief medical officer at the American Society of Clinical Oncology (ASCO), weighs in on the value proposition for cancer drugs and the implications for physicians.
 

Q: What tools exist for determining a drug’s value?

A: A number of organizations have developed tools to try to determine the value of cancer drug treatments. ASCO, the European Society for Medical Oncology (ESMO), the Institute for Clinical and Economic Review, Memorial Sloan Kettering Cancer Center, and the National Comprehensive Cancer Network have all developed tools for this purpose.

Our tool, the ASCO Value Framework, assesses the value of new cancer drug treatments based on clinical benefit, side effects, and improvements in patient symptoms or quality of life in the context of cost. While it’s hard to directly compare frameworks – given differences in methodology and the many nuances of evaluating clinical trial results – in 2018, ASCO and ESMO published a joint analysis of our value frameworks in the Journal of Clinical Oncology (2018; 37[4]:336-49).

The analysis found that the frameworks produce comparable measures of the clinical benefits of new therapies in approximately two-thirds of the more than 100 treatment comparisons that were examined. It also identified a number of factors that may contribute to the discordant scores, revealing potential ways for both of our organizations to refine our frameworks in the future.

That said, ASCO’s Value Framework is just one part of our broader, multifaceted effort to achieve high-quality, high-value care for all patients with cancer. Other efforts include ASCO’s proposed Patient-Centered Oncology Payment model, the Choosing Wisely campaign to identify low-value clinical strategies, and CancerLinQ and the Quality Oncology Practice Initiative to implement quality measurement and improvement.
 

Q: How can the issues around drug price and value be addressed earlier in the context of clinical trials?

A: The definition of value ultimately comes down to the price that must be paid to achieve meaningfully improved health outcomes for individual patients or the broader population of affected individuals. Optimizing the value of a new cancer drug treatment begins with an innovation to address an unmet medical need, followed by defining and achieving clinically meaningful improvements in health outcomes through well-designed and efficiently conducted clinical trials. Effectiveness research is also essential to determining how well new treatments perform compared with available alternatives and how they perform in more diverse populations than those typically included in the clinical trials used to establish efficacy.

Patient goals, preferences, and choices shape the real-world experience of a new product, and the direct and indirect costs of a treatment to patients and their families significantly affect whether it is adopted widely. Until their value is clearly established, new and costly products should be deployed judiciously and after careful consideration of the goals of treatment, available options, and the unique needs, preferences, and goals of individual patients.

More research is needed to improve how we assess the value of new cancer drug treatments. New clinical efficacy endpoints – both provider- and patient-reported ones – that accurately describe how a patient feels and functions must be developed and should reflect outcomes of value to patients other than survival, particularly in noncurative settings.

Better predictive biomarkers can transform a drug of modest efficacy in an unselected population to one of high efficacy in a biomarker-defined subgroup and thereby contribute to improving the value of a treatment.

Regulatory and policy initiatives such as adaptive licensing, value-based insurance, and indication-specific pricing that affect marketing approval, reimbursement, or price, respectively, based on treatment effectiveness, also deserve careful consideration and further research to determine their effects on aligning cost with benefit while ensuring patient access to potentially life-extending therapies and continued innovation in drug development.
 

Q: Aside from the policy options, what’s the role of the oncologist in discussing the value of drugs with patients when determining a treatment plan?

A: Since oncologists don’t control drug prices, our role in improving the value of cancer care involves appropriately managing how resources are used and guiding patients during discussions around the right treatment plan for their particular diagnosis, prognosis, and treatment goals.

Adopting and adhering to high-quality oncology clinical pathways is an important way to improve the quality, efficiency, and value of cancer care. High-quality oncology pathways are detailed, evidence-based treatment protocols for delivering cancer care to patients with specific disease types and stages. When properly designed and implemented, oncology pathways serve as an important tool in appropriately managing cancer care resources and improving the quality of care that patients with cancer receive, while also reducing costs.
 

Dr. Schilsky is the senior vice president and chief medical officer of ASCO. Formerly the chief of hematology/oncology in the department of medicine and deputy director of the University of Chicago Comprehensive Cancer Center, he is a leader in the field of clinical oncology, specializing in new drug development and the treatment of gastrointestinal cancers. Dr. Schilsky reported research funding from several pharmaceutical companies to ASCO for the Targeted Agent and Profiling Utilization Registry (TAPUR) clinical trial. He also reported travel/accommodation/expense support from Varian.

The evidence is robust and disheartening: As if the personal suffering and societal stigma of mental illness are not bad enough, psychiatric patients also have a shorter life­span.¹ In the past, most studies have focused on early mortality and loss of potential life-years in schizophrenia,² but many subsequent reports indicate that premature death occurs in all major psychiatric disorders.

Here is a summary of the sobering facts:

• Schizophrenia. In a study of 30,210 patients with schizophrenia, compared with >5 million individuals in the general population in Denmark (where they have an excellent registry), mortality was 16-fold higher among patients with schizophrenia if they had a single somatic illness.³ The illnesses were mostly respiratory, gastrointestinal, or cardiovascular).³ The loss of potential years of life was staggeringly high: 18.7 years for men, 16.3 years for women.⁴ A study conducted in 8 US states reported a loss of 2 to 3 decades of life across each of these states.⁵ The causes of death in patients with schizophrenia were mainly heart disease, cancer, stroke, and pulmonary diseases. A national database in Sweden found that unmedicated patients with schizophrenia had a significantly higher death rate than those receiving antipsychotics.^6,7 Similar findings were reported by researchers in Finland.⁸ The Swedish study by Tiihonen et al⁶ also found that mortality was highest in patients receiving benzodiazepines along with antipsychotics, but there was no increased mortality among patients with schizophrenia receiving antidepressants.
• Bipolar disorder. A shorter life expectancy has also been reported in bipolar disorder,⁹ with a loss of 13.6 years for men and 12.1 years for women. Early death was caused by physical illness (even when suicide deaths were excluded), especially cardio­vascular disease.¹⁰
• Major depressive disorder (MDD). A reduction of life expectancy in persons with MDD (unipolar depression) has been reported, with a loss of 14 years in men and 10 years in women.¹¹ Although suicide contributed to the shorter lifespan, death due to accidents was 500% higher among persons with unipolar depression; the largest causes of death were physical illnesses. Further, Zubenko et al¹² reported alarming findings about excess mortality among first- and second-degree relatives of persons with early-onset depression (some of whom were bipolar). The relatives died an average of 8 years earlier than the local population, and 40% died before reaching age 65. Also, there was a 5-fold increase in infant mortality (in the first year of life) among the relatives. The most common causes of death in adult relatives were heart disease, cancer, and stroke. It is obvious that MDD has a significant negative impact on health and longevity in both patients and their relatives.
• Attention-deficit/hyperactivity disorder (ADHD). A 220% increase in mortality was reported in persons with ADHD at all ages.¹³ Accidents were the most common cause of death. The mortality rate ratio (MRR) was 1.86 for ADHD before age 6, 1.58 for ADHD between age 6 to 17, and 4.25 for those age ≥18. The rate of early mortality was higher in girls and women (MRR = 2.85) than boys and men (MRR = 1.27).
• Obsessive-compulsive disorder (OCD). A study from Denmark of 10,155 persons with OCD followed for 10 years reported a significantly higher risk of death from both natural (MRR = 1.68) and unnatural causes (MRR = 2.61), compared with the general population.¹⁴ Patients with OCD and comorbid depression, anxiety, or substance use had a further increase in mortality risk, but the mortality risk of individuals with OCD without psychiatric comorbidity was still 200% higher than that of the general population.
• Anxiety disorders. One study found no increase in mortality among patients who have generalized anxiety, unless it was associated with depression.¹⁵ Another study reported that the presence of anxiety reduced the risk of cardiovascular mortality in persons with depression.¹⁶ The absence of increased mortality in anxiety disorders was also confirmed in a meta-analysis of 36 studies.¹⁷ However, a study of postmenopausal women with panic attacks found a 3-fold increase in coronary artery disease and stroke in that cohort,¹⁸ which confirmed the findings of an older study¹⁹ that demonstrated a 2-fold increase of mortality among 155 men with panic disorder after a 12-year follow-up. Also, a 25-year follow-up study found that suicide accounted for 20% of deaths in the anxiety group compared with 16.2% in the depression group,²⁰ showing a significant risk of suicide in panic disorder, even exceeding that of depression.
• Oppositional defiant disorder (ODD) and conduct disorder (CD). In a 12-year follow-up study of 9,495 individuals with “disruptive behavioral disorders,” which included ODD and CD, the mortality rate was >400% higher in these patients compared with 1.92 million individuals in the general population (9.66 vs 2.22 per 10,000 person­-years).²¹ Comorbid substance use disorder and ADHD further increased the mortality rate in this cohort.
• Posttraumatic stress disorder (PTSD). Studies show that there is a significantly increased risk of early cardiovascular mortality in PTSD,²² and that the death rate may be associated with accelerated “DNA methylation age” that leads to a 13% increased risk for all-cause mortality.²³
• Borderline personality disorder (BPD). A recent longitudinal study (24 years of follow-up with evaluation every 2 years) reported a significantly higher mortality in patients with BPD compared with those with other personality disorders. The age range when the study started was 18 to 35. The rate of suicide death was Palatino LT Std>400% higher in BPD (5.9% vs 1.4%). Also, non-suicidal death was 250% higher in BPD (14% vs 5.5%). The causes of non-suicidal death included cardiovascular disease, substance-related complications, cancer, and accidents.²⁴
• Other personality disorders. Certain personality traits have been associated with shorter leukocyte telomeres, which signal early death. These traits include neuroticism, conscientiousness, harm avoidance, and reward dependence.²⁵ Another study found shorter telomeres in persons with high neuroticism and low agreeableness²⁶ regardless of age or sex. Short telomeres, which reflect accelerated cellular senescence and aging, have also been reported in several major psychiatric disorders (schizophrenia, bipolar disorder, MDD, and anxiety).^27-29 The cumulative evidence is unassailable; psychiatric brain disorders are not only associated with premature death due to high suicide rates, but also with multiple medical diseases that lead to early mortality and a shorter lifespan. The shortened telomeres reflect high oxidative stress and inflammation, and both those toxic processes are known to be associated with major psychiatric disorders. Compounding the dismal facts about early mortality due to mental illness are the additional grave medical consequences of alcohol and substance use, which are highly comorbid with most psychiatric disorders, further exacerbating the premature death rates among psychiatric patients.

Continue to: There is an important take-home message...

There is an important take-home message in all of this: Our patients are at high risk for potentially fatal medical conditions that require early detection, and intensive ongoing treatment by a primary care clinician (not “provider”; I abhor the widespread use of that term for physicians or nurse practitioners) is an indispensable component of psychiatric care. Thus, collaborative care is vital to protect our psychiatric patients from early mortality and a shortened lifespan. Psychiatrists and psychiatric nurse practitioners must not only win the battle against mental illness, but also diligently avoid losing the war of life and death.

The evidence is robust and disheartening: As if the personal suffering and societal stigma of mental illness are not bad enough, psychiatric patients also have a shorter life­span.¹ In the past, most studies have focused on early mortality and loss of potential life-years in schizophrenia,² but many subsequent reports indicate that premature death occurs in all major psychiatric disorders.

Here is a summary of the sobering facts:

• Schizophrenia. In a study of 30,210 patients with schizophrenia, compared with >5 million individuals in the general population in Denmark (where they have an excellent registry), mortality was 16-fold higher among patients with schizophrenia if they had a single somatic illness.³ The illnesses were mostly respiratory, gastrointestinal, or cardiovascular).³ The loss of potential years of life was staggeringly high: 18.7 years for men, 16.3 years for women.⁴ A study conducted in 8 US states reported a loss of 2 to 3 decades of life across each of these states.⁵ The causes of death in patients with schizophrenia were mainly heart disease, cancer, stroke, and pulmonary diseases. A national database in Sweden found that unmedicated patients with schizophrenia had a significantly higher death rate than those receiving antipsychotics.^6,7 Similar findings were reported by researchers in Finland.⁸ The Swedish study by Tiihonen et al⁶ also found that mortality was highest in patients receiving benzodiazepines along with antipsychotics, but there was no increased mortality among patients with schizophrenia receiving antidepressants.
• Bipolar disorder. A shorter life expectancy has also been reported in bipolar disorder,⁹ with a loss of 13.6 years for men and 12.1 years for women. Early death was caused by physical illness (even when suicide deaths were excluded), especially cardio­vascular disease.¹⁰
• Major depressive disorder (MDD). A reduction of life expectancy in persons with MDD (unipolar depression) has been reported, with a loss of 14 years in men and 10 years in women.¹¹ Although suicide contributed to the shorter lifespan, death due to accidents was 500% higher among persons with unipolar depression; the largest causes of death were physical illnesses. Further, Zubenko et al¹² reported alarming findings about excess mortality among first- and second-degree relatives of persons with early-onset depression (some of whom were bipolar). The relatives died an average of 8 years earlier than the local population, and 40% died before reaching age 65. Also, there was a 5-fold increase in infant mortality (in the first year of life) among the relatives. The most common causes of death in adult relatives were heart disease, cancer, and stroke. It is obvious that MDD has a significant negative impact on health and longevity in both patients and their relatives.
• Attention-deficit/hyperactivity disorder (ADHD). A 220% increase in mortality was reported in persons with ADHD at all ages.¹³ Accidents were the most common cause of death. The mortality rate ratio (MRR) was 1.86 for ADHD before age 6, 1.58 for ADHD between age 6 to 17, and 4.25 for those age ≥18. The rate of early mortality was higher in girls and women (MRR = 2.85) than boys and men (MRR = 1.27).
• Obsessive-compulsive disorder (OCD). A study from Denmark of 10,155 persons with OCD followed for 10 years reported a significantly higher risk of death from both natural (MRR = 1.68) and unnatural causes (MRR = 2.61), compared with the general population.¹⁴ Patients with OCD and comorbid depression, anxiety, or substance use had a further increase in mortality risk, but the mortality risk of individuals with OCD without psychiatric comorbidity was still 200% higher than that of the general population.
• Anxiety disorders. One study found no increase in mortality among patients who have generalized anxiety, unless it was associated with depression.¹⁵ Another study reported that the presence of anxiety reduced the risk of cardiovascular mortality in persons with depression.¹⁶ The absence of increased mortality in anxiety disorders was also confirmed in a meta-analysis of 36 studies.¹⁷ However, a study of postmenopausal women with panic attacks found a 3-fold increase in coronary artery disease and stroke in that cohort,¹⁸ which confirmed the findings of an older study¹⁹ that demonstrated a 2-fold increase of mortality among 155 men with panic disorder after a 12-year follow-up. Also, a 25-year follow-up study found that suicide accounted for 20% of deaths in the anxiety group compared with 16.2% in the depression group,²⁰ showing a significant risk of suicide in panic disorder, even exceeding that of depression.
• Oppositional defiant disorder (ODD) and conduct disorder (CD). In a 12-year follow-up study of 9,495 individuals with “disruptive behavioral disorders,” which included ODD and CD, the mortality rate was >400% higher in these patients compared with 1.92 million individuals in the general population (9.66 vs 2.22 per 10,000 person­-years).²¹ Comorbid substance use disorder and ADHD further increased the mortality rate in this cohort.
• Posttraumatic stress disorder (PTSD). Studies show that there is a significantly increased risk of early cardiovascular mortality in PTSD,²² and that the death rate may be associated with accelerated “DNA methylation age” that leads to a 13% increased risk for all-cause mortality.²³
• Borderline personality disorder (BPD). A recent longitudinal study (24 years of follow-up with evaluation every 2 years) reported a significantly higher mortality in patients with BPD compared with those with other personality disorders. The age range when the study started was 18 to 35. The rate of suicide death was Palatino LT Std>400% higher in BPD (5.9% vs 1.4%). Also, non-suicidal death was 250% higher in BPD (14% vs 5.5%). The causes of non-suicidal death included cardiovascular disease, substance-related complications, cancer, and accidents.²⁴
• Other personality disorders. Certain personality traits have been associated with shorter leukocyte telomeres, which signal early death. These traits include neuroticism, conscientiousness, harm avoidance, and reward dependence.²⁵ Another study found shorter telomeres in persons with high neuroticism and low agreeableness²⁶ regardless of age or sex. Short telomeres, which reflect accelerated cellular senescence and aging, have also been reported in several major psychiatric disorders (schizophrenia, bipolar disorder, MDD, and anxiety).^27-29 The cumulative evidence is unassailable; psychiatric brain disorders are not only associated with premature death due to high suicide rates, but also with multiple medical diseases that lead to early mortality and a shorter lifespan. The shortened telomeres reflect high oxidative stress and inflammation, and both those toxic processes are known to be associated with major psychiatric disorders. Compounding the dismal facts about early mortality due to mental illness are the additional grave medical consequences of alcohol and substance use, which are highly comorbid with most psychiatric disorders, further exacerbating the premature death rates among psychiatric patients.

Continue to: There is an important take-home message...

There is an important take-home message in all of this: Our patients are at high risk for potentially fatal medical conditions that require early detection, and intensive ongoing treatment by a primary care clinician (not “provider”; I abhor the widespread use of that term for physicians or nurse practitioners) is an indispensable component of psychiatric care. Thus, collaborative care is vital to protect our psychiatric patients from early mortality and a shortened lifespan. Psychiatrists and psychiatric nurse practitioners must not only win the battle against mental illness, but also diligently avoid losing the war of life and death.

The evidence is robust and disheartening: As if the personal suffering and societal stigma of mental illness are not bad enough, psychiatric patients also have a shorter life­span.¹ In the past, most studies have focused on early mortality and loss of potential life-years in schizophrenia,² but many subsequent reports indicate that premature death occurs in all major psychiatric disorders.

Here is a summary of the sobering facts:

• Schizophrenia. In a study of 30,210 patients with schizophrenia, compared with >5 million individuals in the general population in Denmark (where they have an excellent registry), mortality was 16-fold higher among patients with schizophrenia if they had a single somatic illness.³ The illnesses were mostly respiratory, gastrointestinal, or cardiovascular).³ The loss of potential years of life was staggeringly high: 18.7 years for men, 16.3 years for women.⁴ A study conducted in 8 US states reported a loss of 2 to 3 decades of life across each of these states.⁵ The causes of death in patients with schizophrenia were mainly heart disease, cancer, stroke, and pulmonary diseases. A national database in Sweden found that unmedicated patients with schizophrenia had a significantly higher death rate than those receiving antipsychotics.^6,7 Similar findings were reported by researchers in Finland.⁸ The Swedish study by Tiihonen et al⁶ also found that mortality was highest in patients receiving benzodiazepines along with antipsychotics, but there was no increased mortality among patients with schizophrenia receiving antidepressants.
• Bipolar disorder. A shorter life expectancy has also been reported in bipolar disorder,⁹ with a loss of 13.6 years for men and 12.1 years for women. Early death was caused by physical illness (even when suicide deaths were excluded), especially cardio­vascular disease.¹⁰
• Major depressive disorder (MDD). A reduction of life expectancy in persons with MDD (unipolar depression) has been reported, with a loss of 14 years in men and 10 years in women.¹¹ Although suicide contributed to the shorter lifespan, death due to accidents was 500% higher among persons with unipolar depression; the largest causes of death were physical illnesses. Further, Zubenko et al¹² reported alarming findings about excess mortality among first- and second-degree relatives of persons with early-onset depression (some of whom were bipolar). The relatives died an average of 8 years earlier than the local population, and 40% died before reaching age 65. Also, there was a 5-fold increase in infant mortality (in the first year of life) among the relatives. The most common causes of death in adult relatives were heart disease, cancer, and stroke. It is obvious that MDD has a significant negative impact on health and longevity in both patients and their relatives.
• Attention-deficit/hyperactivity disorder (ADHD). A 220% increase in mortality was reported in persons with ADHD at all ages.¹³ Accidents were the most common cause of death. The mortality rate ratio (MRR) was 1.86 for ADHD before age 6, 1.58 for ADHD between age 6 to 17, and 4.25 for those age ≥18. The rate of early mortality was higher in girls and women (MRR = 2.85) than boys and men (MRR = 1.27).
• Obsessive-compulsive disorder (OCD). A study from Denmark of 10,155 persons with OCD followed for 10 years reported a significantly higher risk of death from both natural (MRR = 1.68) and unnatural causes (MRR = 2.61), compared with the general population.¹⁴ Patients with OCD and comorbid depression, anxiety, or substance use had a further increase in mortality risk, but the mortality risk of individuals with OCD without psychiatric comorbidity was still 200% higher than that of the general population.
• Anxiety disorders. One study found no increase in mortality among patients who have generalized anxiety, unless it was associated with depression.¹⁵ Another study reported that the presence of anxiety reduced the risk of cardiovascular mortality in persons with depression.¹⁶ The absence of increased mortality in anxiety disorders was also confirmed in a meta-analysis of 36 studies.¹⁷ However, a study of postmenopausal women with panic attacks found a 3-fold increase in coronary artery disease and stroke in that cohort,¹⁸ which confirmed the findings of an older study¹⁹ that demonstrated a 2-fold increase of mortality among 155 men with panic disorder after a 12-year follow-up. Also, a 25-year follow-up study found that suicide accounted for 20% of deaths in the anxiety group compared with 16.2% in the depression group,²⁰ showing a significant risk of suicide in panic disorder, even exceeding that of depression.
• Oppositional defiant disorder (ODD) and conduct disorder (CD). In a 12-year follow-up study of 9,495 individuals with “disruptive behavioral disorders,” which included ODD and CD, the mortality rate was >400% higher in these patients compared with 1.92 million individuals in the general population (9.66 vs 2.22 per 10,000 person­-years).²¹ Comorbid substance use disorder and ADHD further increased the mortality rate in this cohort.
• Posttraumatic stress disorder (PTSD). Studies show that there is a significantly increased risk of early cardiovascular mortality in PTSD,²² and that the death rate may be associated with accelerated “DNA methylation age” that leads to a 13% increased risk for all-cause mortality.²³
• Borderline personality disorder (BPD). A recent longitudinal study (24 years of follow-up with evaluation every 2 years) reported a significantly higher mortality in patients with BPD compared with those with other personality disorders. The age range when the study started was 18 to 35. The rate of suicide death was Palatino LT Std>400% higher in BPD (5.9% vs 1.4%). Also, non-suicidal death was 250% higher in BPD (14% vs 5.5%). The causes of non-suicidal death included cardiovascular disease, substance-related complications, cancer, and accidents.²⁴
• Other personality disorders. Certain personality traits have been associated with shorter leukocyte telomeres, which signal early death. These traits include neuroticism, conscientiousness, harm avoidance, and reward dependence.²⁵ Another study found shorter telomeres in persons with high neuroticism and low agreeableness²⁶ regardless of age or sex. Short telomeres, which reflect accelerated cellular senescence and aging, have also been reported in several major psychiatric disorders (schizophrenia, bipolar disorder, MDD, and anxiety).^27-29 The cumulative evidence is unassailable; psychiatric brain disorders are not only associated with premature death due to high suicide rates, but also with multiple medical diseases that lead to early mortality and a shorter lifespan. The shortened telomeres reflect high oxidative stress and inflammation, and both those toxic processes are known to be associated with major psychiatric disorders. Compounding the dismal facts about early mortality due to mental illness are the additional grave medical consequences of alcohol and substance use, which are highly comorbid with most psychiatric disorders, further exacerbating the premature death rates among psychiatric patients.

Continue to: There is an important take-home message...

There is an important take-home message in all of this: Our patients are at high risk for potentially fatal medical conditions that require early detection, and intensive ongoing treatment by a primary care clinician (not “provider”; I abhor the widespread use of that term for physicians or nurse practitioners) is an indispensable component of psychiatric care. Thus, collaborative care is vital to protect our psychiatric patients from early mortality and a shortened lifespan. Psychiatrists and psychiatric nurse practitioners must not only win the battle against mental illness, but also diligently avoid losing the war of life and death.

Question: Which one of the following statements regarding medication warnings is incorrect?

A. The drug package “insert” or “label” contains, among other things, a drug’s pharmacology, indications, contraindications, risks and warnings.

B. The Physicians’ Desk Reference (PDR) is an annually updated drug compendium, which can be admitted into evidence as a learned treatise.

C. Drug labeling is a dual responsibility of the manufacturer and the Food and Drug Administration.

D. The FDA is solely responsible for a drug’s warnings and sets the absolute standard of care regarding side effects and complications.

E. State law can impose liability for negligent failure to warn even if the FDA has not included the warning in the drug’s label.

Answer: D. Should a prescription drug or medical device lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. In medical products liability, injured plaintiffs frequently claim a failure to warn of known risks. An example is the cardiovascular deaths caused by Vioxx, a nonsteroidal, anti-inflammatory drug that was withdrawn in 2004. Other examples alleging failure to warn are Actos-associated bladder cancer and Baycol-related rhabdomyolysis. At the time of product approval, the FDA sets out the labeling that goes with each drug, and then makes periodic changes to reflect new indications, warnings and risks. The manufacturer has the prime responsibility for submitting all updated information, especially of augmented risks that come with field experience. In 2012, for example, the FDA mandated the revision of the labeling of Lipitor and other statins to warn of the increased risk of diabetes.

The drug manufacturer stands in the unique position as having the most detailed and up-to-date data and bears a serious responsibility to submit its full findings to the FDA, including its request for label change. Litigation over failure to warn of risks frequently turns on whether the drug manufacturer knew or should have known, had failed to inform the FDA, or whether the FDA itself had declined to make the changes, e.g., because of incomplete or premature data. Notwithstanding the FDA’s overarching federal status, a plaintiff may still attempt to use state tort law to hold a manufacturer liable should the federally approved labeling be silent on the matter.

Two U.S. Supreme Court cases sought to clarify the rules under which a drug manufacturer, when sued for failure to warn, may seek protection under its FDA-approved labeling. The first case involved Diana Levine, a Vermont musician and migraine sufferer, who lost her arm after the drug Phenergan, given by intravenous push, accidentally entered an artery and caused gangrene. Although the intravenous use of Phenergan is approved by the FDA and the risk of such use is clearly stated in the drug’s package insert, the lawsuit alleged that under state law, such a warning was inadequate and should have been strengthened to prohibit this mode of administration. A Vermont jury awarded damages of $6.7 million. On appeal, Wyeth, the defendant pharmaceutical company, maintained that its warning was appropriate, as it had been approved by the federal government through the FDA. It further argued that the drug’s package insert could not be unilaterally altered or modified without running afoul of federal regulations.

In a 6-3 decision,¹ the U.S. Supreme Court ruled that the manufacturer was in fact at liberty to issue a more stringent warning, and FDA approval does not bar lawsuits. The Court opined that “Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Wyeth had argued that it was impossible for the company to provide additional warnings, since it was the FDA that made the sole determination of the nature and scope of a drug’s label. However, the court held that Wyeth never attempted to change the label to warn of the risk and failed to provide “clear” evidence that the FDA would have prevented it from changing its label. Without defining what constituted “clear” evidence, it rejected Wyeth’s broad assertion that unilaterally changing the Phenergan label would have violated federal law, which was based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.

In 2019, the landmark case of Merck Sharp & Dohme Corp v. Albrecht et al.² reached the U.S. Supreme Court. This class-action suit involved more than 500 individuals who took Fosamax, an effective anti-resorptive drug for treating osteoporosis, and suffered atypical femoral fractures between 1999 and 2010. When the FDA first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculative risk of atypical femoral fractures. But stronger evidence connecting Fosamax to atypical fractures developed after 1995, prompting the FDA to add a warning in 2011. Merck argued that plaintiffs’ state-law failure-to-warn claims should be dismissed as preempted by federal law. It conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010 but believed the FDA would have rejected that attempt. In particular, it claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk of atypical femoral fractures. In short, Merck was relying on the legal doctrine of “impossibility preemption,” i.e., it was impossible to comply with both state law (adequate label warning of atypical fractures) and federal law (FDA control of warning labels). The plaintiffs’ position was that Merck’s proposed warning to the FDA had minimized the seriousness of the femoral fracture risk, characterizing them only as “stress fractures.”³

The Court’s earlier Levine decision had held that a state-law failure-to-warn claim is preempted where there is “clear” evidence the FDA would not have approved a label change. In the Albrecht decision, which also sided with the plaintiffs, the court indicated that “Clear evidence is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” The court also held that issues relating to presumption of impossibility are law-based, and thus it remains for the judge, not the jury, to make that determination.

Issuing timely warnings regarding medical products promotes patient safety, and the law appears to place the major onus on the manufacturer. Still, striking the proper balance is important. During oral arguments in Albrecht, Associate Justice Neil Gorsuch is said to have cautioned against “ ... incentives for companies to submit weakly supported label changes to the agency, knowing that when those label changes are rejected the companies will be free of further liability.” And as pointed out in the earlier cited Johnston article: “ ... a system that creates incentives for manufacturers to over-warn physicians and patients could harm patients by listing the important warnings of adverse effects among numerous less important warnings, which may discourage physicians and patients from choosing potentially useful drugs. On the other hand, a shift of responsibility for labeling to the FDA raises questions about whether the agency, which has resources that are dwarfed by the combined resources of industry, is necessarily capable to serve in this role ...”

Finally, this issue is more complex for devices because of the Medical Device Amendments Act of 1976 (MDA), which may preempt state-based lawsuits. In a claim brought after a Medtronic catheter ruptured in a patient’s coronary artery during heart surgery, the plaintiff alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The case was appealed to the U.S. Supreme Court. The court held that the MDA preempted petitioner’s common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.⁴ The court ruled that MDA created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes.
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

References

1. Wyeth v. Levine, 555 U.S. 2 (2009).

2. Merck, Sharp & Dohme Corp. v. Albrecht et al., 587 U. S. ____ (2019).

3. Johnston MC et al., A new Supreme Court ruling on drug liability. JAMA 2019;322(7):607-8.

4. Riegel v. Medtronic, 128 S. Ct. 999 (2008).

Question: Which one of the following statements regarding medication warnings is incorrect?

A. The drug package “insert” or “label” contains, among other things, a drug’s pharmacology, indications, contraindications, risks and warnings.

B. The Physicians’ Desk Reference (PDR) is an annually updated drug compendium, which can be admitted into evidence as a learned treatise.

C. Drug labeling is a dual responsibility of the manufacturer and the Food and Drug Administration.

D. The FDA is solely responsible for a drug’s warnings and sets the absolute standard of care regarding side effects and complications.

E. State law can impose liability for negligent failure to warn even if the FDA has not included the warning in the drug’s label.

Answer: D. Should a prescription drug or medical device lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. In medical products liability, injured plaintiffs frequently claim a failure to warn of known risks. An example is the cardiovascular deaths caused by Vioxx, a nonsteroidal, anti-inflammatory drug that was withdrawn in 2004. Other examples alleging failure to warn are Actos-associated bladder cancer and Baycol-related rhabdomyolysis. At the time of product approval, the FDA sets out the labeling that goes with each drug, and then makes periodic changes to reflect new indications, warnings and risks. The manufacturer has the prime responsibility for submitting all updated information, especially of augmented risks that come with field experience. In 2012, for example, the FDA mandated the revision of the labeling of Lipitor and other statins to warn of the increased risk of diabetes.

The drug manufacturer stands in the unique position as having the most detailed and up-to-date data and bears a serious responsibility to submit its full findings to the FDA, including its request for label change. Litigation over failure to warn of risks frequently turns on whether the drug manufacturer knew or should have known, had failed to inform the FDA, or whether the FDA itself had declined to make the changes, e.g., because of incomplete or premature data. Notwithstanding the FDA’s overarching federal status, a plaintiff may still attempt to use state tort law to hold a manufacturer liable should the federally approved labeling be silent on the matter.

Two U.S. Supreme Court cases sought to clarify the rules under which a drug manufacturer, when sued for failure to warn, may seek protection under its FDA-approved labeling. The first case involved Diana Levine, a Vermont musician and migraine sufferer, who lost her arm after the drug Phenergan, given by intravenous push, accidentally entered an artery and caused gangrene. Although the intravenous use of Phenergan is approved by the FDA and the risk of such use is clearly stated in the drug’s package insert, the lawsuit alleged that under state law, such a warning was inadequate and should have been strengthened to prohibit this mode of administration. A Vermont jury awarded damages of $6.7 million. On appeal, Wyeth, the defendant pharmaceutical company, maintained that its warning was appropriate, as it had been approved by the federal government through the FDA. It further argued that the drug’s package insert could not be unilaterally altered or modified without running afoul of federal regulations.

In a 6-3 decision,¹ the U.S. Supreme Court ruled that the manufacturer was in fact at liberty to issue a more stringent warning, and FDA approval does not bar lawsuits. The Court opined that “Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Wyeth had argued that it was impossible for the company to provide additional warnings, since it was the FDA that made the sole determination of the nature and scope of a drug’s label. However, the court held that Wyeth never attempted to change the label to warn of the risk and failed to provide “clear” evidence that the FDA would have prevented it from changing its label. Without defining what constituted “clear” evidence, it rejected Wyeth’s broad assertion that unilaterally changing the Phenergan label would have violated federal law, which was based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.

In 2019, the landmark case of Merck Sharp & Dohme Corp v. Albrecht et al.² reached the U.S. Supreme Court. This class-action suit involved more than 500 individuals who took Fosamax, an effective anti-resorptive drug for treating osteoporosis, and suffered atypical femoral fractures between 1999 and 2010. When the FDA first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculative risk of atypical femoral fractures. But stronger evidence connecting Fosamax to atypical fractures developed after 1995, prompting the FDA to add a warning in 2011. Merck argued that plaintiffs’ state-law failure-to-warn claims should be dismissed as preempted by federal law. It conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010 but believed the FDA would have rejected that attempt. In particular, it claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk of atypical femoral fractures. In short, Merck was relying on the legal doctrine of “impossibility preemption,” i.e., it was impossible to comply with both state law (adequate label warning of atypical fractures) and federal law (FDA control of warning labels). The plaintiffs’ position was that Merck’s proposed warning to the FDA had minimized the seriousness of the femoral fracture risk, characterizing them only as “stress fractures.”³

The Court’s earlier Levine decision had held that a state-law failure-to-warn claim is preempted where there is “clear” evidence the FDA would not have approved a label change. In the Albrecht decision, which also sided with the plaintiffs, the court indicated that “Clear evidence is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” The court also held that issues relating to presumption of impossibility are law-based, and thus it remains for the judge, not the jury, to make that determination.

Issuing timely warnings regarding medical products promotes patient safety, and the law appears to place the major onus on the manufacturer. Still, striking the proper balance is important. During oral arguments in Albrecht, Associate Justice Neil Gorsuch is said to have cautioned against “ ... incentives for companies to submit weakly supported label changes to the agency, knowing that when those label changes are rejected the companies will be free of further liability.” And as pointed out in the earlier cited Johnston article: “ ... a system that creates incentives for manufacturers to over-warn physicians and patients could harm patients by listing the important warnings of adverse effects among numerous less important warnings, which may discourage physicians and patients from choosing potentially useful drugs. On the other hand, a shift of responsibility for labeling to the FDA raises questions about whether the agency, which has resources that are dwarfed by the combined resources of industry, is necessarily capable to serve in this role ...”

Finally, this issue is more complex for devices because of the Medical Device Amendments Act of 1976 (MDA), which may preempt state-based lawsuits. In a claim brought after a Medtronic catheter ruptured in a patient’s coronary artery during heart surgery, the plaintiff alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The case was appealed to the U.S. Supreme Court. The court held that the MDA preempted petitioner’s common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.⁴ The court ruled that MDA created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes.
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

References

1. Wyeth v. Levine, 555 U.S. 2 (2009).

2. Merck, Sharp & Dohme Corp. v. Albrecht et al., 587 U. S. ____ (2019).

3. Johnston MC et al., A new Supreme Court ruling on drug liability. JAMA 2019;322(7):607-8.

4. Riegel v. Medtronic, 128 S. Ct. 999 (2008).

Question: Which one of the following statements regarding medication warnings is incorrect?

A. The drug package “insert” or “label” contains, among other things, a drug’s pharmacology, indications, contraindications, risks and warnings.

B. The Physicians’ Desk Reference (PDR) is an annually updated drug compendium, which can be admitted into evidence as a learned treatise.

C. Drug labeling is a dual responsibility of the manufacturer and the Food and Drug Administration.

D. The FDA is solely responsible for a drug’s warnings and sets the absolute standard of care regarding side effects and complications.

E. State law can impose liability for negligent failure to warn even if the FDA has not included the warning in the drug’s label.

Answer: D. Should a prescription drug or medical device lead to harm, an injured party can sue the manufacturer who had placed it into the stream of commerce. In medical products liability, injured plaintiffs frequently claim a failure to warn of known risks. An example is the cardiovascular deaths caused by Vioxx, a nonsteroidal, anti-inflammatory drug that was withdrawn in 2004. Other examples alleging failure to warn are Actos-associated bladder cancer and Baycol-related rhabdomyolysis. At the time of product approval, the FDA sets out the labeling that goes with each drug, and then makes periodic changes to reflect new indications, warnings and risks. The manufacturer has the prime responsibility for submitting all updated information, especially of augmented risks that come with field experience. In 2012, for example, the FDA mandated the revision of the labeling of Lipitor and other statins to warn of the increased risk of diabetes.

The drug manufacturer stands in the unique position as having the most detailed and up-to-date data and bears a serious responsibility to submit its full findings to the FDA, including its request for label change. Litigation over failure to warn of risks frequently turns on whether the drug manufacturer knew or should have known, had failed to inform the FDA, or whether the FDA itself had declined to make the changes, e.g., because of incomplete or premature data. Notwithstanding the FDA’s overarching federal status, a plaintiff may still attempt to use state tort law to hold a manufacturer liable should the federally approved labeling be silent on the matter.

Two U.S. Supreme Court cases sought to clarify the rules under which a drug manufacturer, when sued for failure to warn, may seek protection under its FDA-approved labeling. The first case involved Diana Levine, a Vermont musician and migraine sufferer, who lost her arm after the drug Phenergan, given by intravenous push, accidentally entered an artery and caused gangrene. Although the intravenous use of Phenergan is approved by the FDA and the risk of such use is clearly stated in the drug’s package insert, the lawsuit alleged that under state law, such a warning was inadequate and should have been strengthened to prohibit this mode of administration. A Vermont jury awarded damages of $6.7 million. On appeal, Wyeth, the defendant pharmaceutical company, maintained that its warning was appropriate, as it had been approved by the federal government through the FDA. It further argued that the drug’s package insert could not be unilaterally altered or modified without running afoul of federal regulations.

In a 6-3 decision,¹ the U.S. Supreme Court ruled that the manufacturer was in fact at liberty to issue a more stringent warning, and FDA approval does not bar lawsuits. The Court opined that “Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Wyeth had argued that it was impossible for the company to provide additional warnings, since it was the FDA that made the sole determination of the nature and scope of a drug’s label. However, the court held that Wyeth never attempted to change the label to warn of the risk and failed to provide “clear” evidence that the FDA would have prevented it from changing its label. Without defining what constituted “clear” evidence, it rejected Wyeth’s broad assertion that unilaterally changing the Phenergan label would have violated federal law, which was based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.

In 2019, the landmark case of Merck Sharp & Dohme Corp v. Albrecht et al.² reached the U.S. Supreme Court. This class-action suit involved more than 500 individuals who took Fosamax, an effective anti-resorptive drug for treating osteoporosis, and suffered atypical femoral fractures between 1999 and 2010. When the FDA first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculative risk of atypical femoral fractures. But stronger evidence connecting Fosamax to atypical fractures developed after 1995, prompting the FDA to add a warning in 2011. Merck argued that plaintiffs’ state-law failure-to-warn claims should be dismissed as preempted by federal law. It conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010 but believed the FDA would have rejected that attempt. In particular, it claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk of atypical femoral fractures. In short, Merck was relying on the legal doctrine of “impossibility preemption,” i.e., it was impossible to comply with both state law (adequate label warning of atypical fractures) and federal law (FDA control of warning labels). The plaintiffs’ position was that Merck’s proposed warning to the FDA had minimized the seriousness of the femoral fracture risk, characterizing them only as “stress fractures.”³

The Court’s earlier Levine decision had held that a state-law failure-to-warn claim is preempted where there is “clear” evidence the FDA would not have approved a label change. In the Albrecht decision, which also sided with the plaintiffs, the court indicated that “Clear evidence is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.” The court also held that issues relating to presumption of impossibility are law-based, and thus it remains for the judge, not the jury, to make that determination.

Issuing timely warnings regarding medical products promotes patient safety, and the law appears to place the major onus on the manufacturer. Still, striking the proper balance is important. During oral arguments in Albrecht, Associate Justice Neil Gorsuch is said to have cautioned against “ ... incentives for companies to submit weakly supported label changes to the agency, knowing that when those label changes are rejected the companies will be free of further liability.” And as pointed out in the earlier cited Johnston article: “ ... a system that creates incentives for manufacturers to over-warn physicians and patients could harm patients by listing the important warnings of adverse effects among numerous less important warnings, which may discourage physicians and patients from choosing potentially useful drugs. On the other hand, a shift of responsibility for labeling to the FDA raises questions about whether the agency, which has resources that are dwarfed by the combined resources of industry, is necessarily capable to serve in this role ...”

Finally, this issue is more complex for devices because of the Medical Device Amendments Act of 1976 (MDA), which may preempt state-based lawsuits. In a claim brought after a Medtronic catheter ruptured in a patient’s coronary artery during heart surgery, the plaintiff alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The case was appealed to the U.S. Supreme Court. The court held that the MDA preempted petitioner’s common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA.⁴ The court ruled that MDA created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes.
 

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

References

1. Wyeth v. Levine, 555 U.S. 2 (2009).

2. Merck, Sharp & Dohme Corp. v. Albrecht et al., 587 U. S. ____ (2019).

3. Johnston MC et al., A new Supreme Court ruling on drug liability. JAMA 2019;322(7):607-8.

4. Riegel v. Medtronic, 128 S. Ct. 999 (2008).

Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.¹There are several unique needs of trans patients that extend into obstetrics and may be addressed as early as the first gender transition visit. Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.

Stuart Jenner/Thinkstock

The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.² Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.³ A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.²

If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.² When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).

Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.² If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.

The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.⁴ Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.

The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.

In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.¹ We found only one case report of induced lactation in a nonpuerperal transfeminine patient.⁵ In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.

Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].

References

1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.

2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.

3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.

4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.

5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.

Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.¹There are several unique needs of trans patients that extend into obstetrics and may be addressed as early as the first gender transition visit. Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.

Stuart Jenner/Thinkstock

The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.² Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.³ A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.²

If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.² When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).

Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.² If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.

The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.⁴ Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.

The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.

In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.¹ We found only one case report of induced lactation in a nonpuerperal transfeminine patient.⁵ In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.

Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].

References

1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.

2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.

3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.

4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.

5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.

Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.¹There are several unique needs of trans patients that extend into obstetrics and may be addressed as early as the first gender transition visit. Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.

Stuart Jenner/Thinkstock

The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.² Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.³ A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.²

If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.² When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).

Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.² If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.

The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.⁴ Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.

The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.

In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.¹ We found only one case report of induced lactation in a nonpuerperal transfeminine patient.⁵ In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.

Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.

Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].

References

1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.

2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.

3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.

4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.

5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.

If you are still struggling to understand the ADHD phenomenon and its meteoric rise to prominence over the last 3 or 4 decades, a study published in the September 2019 Pediatrics may help you make sense of why you are spending a large part of your professional day counseling parents and treating children whose lives are disrupted by their impulsivity, distractibility, and inattentiveness (“24-hour movement behaviors and impulsivity.” doi: 10.1542/peds.2019-0187). Researchers at the Children’s Hospital of Eastern Ontario (Canada) Research Institute used data collected over 10 years in 21 sites across the United States on more than 4,500 children aged 8-11 years, looking for possible associations between impulsivity and three factors – sleep duration, screen time, and physical activity.

Goads Agency/Getty Images

They found that children who were exposed to fewer than 2 hours of recreational screen time each day and slept 9-11 hours nightly had significantly reduced scores on a range of impulsivity scores. While participating in at least 60 minutes of vigorous physical activity per day also was associated with less impulsivity, the effect added little to the benefit of the sleep/screen time combination. Although these nonpharmacologic strategies aimed at decreasing impulsivity may not be a cure-all for every child with symptoms that suggest ADHD, the data are compelling.

I hope that the associations these Canadian researchers have unearthed is not news to you. But their observation that 30% of the sample population met none of the recommendations for sleep, screen time, and activity and that only 5% of the sample did suggests that too few of us are delivering the message with sufficient enthusiasm and/or too many parents aren’t taking it seriously.

Over the last several years I have been encouraged to find sleep and screen time limits mentioned in articles on ADHD for both professionals and parents, but these potent contributors to impulsivity and distractibility always seem to be relegated to the oh-by-the-way category at the end of the article after a lengthy discussion of the relative values of medication and cognitive-behavioral therapy. And unfortunately, meeting these behavioral guidelines can be difficult to achieve and cannot be subcontracted out to a therapist or a pharmacist. They require parents to set and enforce limits. Saying no is difficult for all of us, particularly those without much prior experience.

Have you observed the association between inadequate sleep, excessive screen time, and impulsivity? How robustly have you bought into the idea that more sleep and less screen time are, if not THE answers, at least are the two we should start with? Where do your recommendations about screen time, sleep, and physical activity fit into the script when you are talking with parents about their child’s ADHD-ish behaviors? Have you put them in the oh-by-the-way category?

Do you ever say, “I know you may be expecting me to talk about medication at this visit, but I suggest you try setting and enforcing these limits on sleep and screen time for a few months and we will see how things are going”? “And I am going to give you some suggestions on how you can do this, and we will meet again as often as you feel is necessary to ease the process.”

Do you think you have the time to try this approach? Do you feel you have the skills to counsel on sleep and behavior? Do you think you can find someone with the time and experience who shares your priorities about screen time and sleep to do the parental coaching for you? It’s an approach worth considering when you step back and take the longer look at why we are living through this decades-long ADHD phenomenon.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

If you are still struggling to understand the ADHD phenomenon and its meteoric rise to prominence over the last 3 or 4 decades, a study published in the September 2019 Pediatrics may help you make sense of why you are spending a large part of your professional day counseling parents and treating children whose lives are disrupted by their impulsivity, distractibility, and inattentiveness (“24-hour movement behaviors and impulsivity.” doi: 10.1542/peds.2019-0187). Researchers at the Children’s Hospital of Eastern Ontario (Canada) Research Institute used data collected over 10 years in 21 sites across the United States on more than 4,500 children aged 8-11 years, looking for possible associations between impulsivity and three factors – sleep duration, screen time, and physical activity.

Goads Agency/Getty Images

They found that children who were exposed to fewer than 2 hours of recreational screen time each day and slept 9-11 hours nightly had significantly reduced scores on a range of impulsivity scores. While participating in at least 60 minutes of vigorous physical activity per day also was associated with less impulsivity, the effect added little to the benefit of the sleep/screen time combination. Although these nonpharmacologic strategies aimed at decreasing impulsivity may not be a cure-all for every child with symptoms that suggest ADHD, the data are compelling.

I hope that the associations these Canadian researchers have unearthed is not news to you. But their observation that 30% of the sample population met none of the recommendations for sleep, screen time, and activity and that only 5% of the sample did suggests that too few of us are delivering the message with sufficient enthusiasm and/or too many parents aren’t taking it seriously.

Over the last several years I have been encouraged to find sleep and screen time limits mentioned in articles on ADHD for both professionals and parents, but these potent contributors to impulsivity and distractibility always seem to be relegated to the oh-by-the-way category at the end of the article after a lengthy discussion of the relative values of medication and cognitive-behavioral therapy. And unfortunately, meeting these behavioral guidelines can be difficult to achieve and cannot be subcontracted out to a therapist or a pharmacist. They require parents to set and enforce limits. Saying no is difficult for all of us, particularly those without much prior experience.

Have you observed the association between inadequate sleep, excessive screen time, and impulsivity? How robustly have you bought into the idea that more sleep and less screen time are, if not THE answers, at least are the two we should start with? Where do your recommendations about screen time, sleep, and physical activity fit into the script when you are talking with parents about their child’s ADHD-ish behaviors? Have you put them in the oh-by-the-way category?

Do you ever say, “I know you may be expecting me to talk about medication at this visit, but I suggest you try setting and enforcing these limits on sleep and screen time for a few months and we will see how things are going”? “And I am going to give you some suggestions on how you can do this, and we will meet again as often as you feel is necessary to ease the process.”

Do you think you have the time to try this approach? Do you feel you have the skills to counsel on sleep and behavior? Do you think you can find someone with the time and experience who shares your priorities about screen time and sleep to do the parental coaching for you? It’s an approach worth considering when you step back and take the longer look at why we are living through this decades-long ADHD phenomenon.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

If you are still struggling to understand the ADHD phenomenon and its meteoric rise to prominence over the last 3 or 4 decades, a study published in the September 2019 Pediatrics may help you make sense of why you are spending a large part of your professional day counseling parents and treating children whose lives are disrupted by their impulsivity, distractibility, and inattentiveness (“24-hour movement behaviors and impulsivity.” doi: 10.1542/peds.2019-0187). Researchers at the Children’s Hospital of Eastern Ontario (Canada) Research Institute used data collected over 10 years in 21 sites across the United States on more than 4,500 children aged 8-11 years, looking for possible associations between impulsivity and three factors – sleep duration, screen time, and physical activity.

Goads Agency/Getty Images

They found that children who were exposed to fewer than 2 hours of recreational screen time each day and slept 9-11 hours nightly had significantly reduced scores on a range of impulsivity scores. While participating in at least 60 minutes of vigorous physical activity per day also was associated with less impulsivity, the effect added little to the benefit of the sleep/screen time combination. Although these nonpharmacologic strategies aimed at decreasing impulsivity may not be a cure-all for every child with symptoms that suggest ADHD, the data are compelling.

I hope that the associations these Canadian researchers have unearthed is not news to you. But their observation that 30% of the sample population met none of the recommendations for sleep, screen time, and activity and that only 5% of the sample did suggests that too few of us are delivering the message with sufficient enthusiasm and/or too many parents aren’t taking it seriously.

Over the last several years I have been encouraged to find sleep and screen time limits mentioned in articles on ADHD for both professionals and parents, but these potent contributors to impulsivity and distractibility always seem to be relegated to the oh-by-the-way category at the end of the article after a lengthy discussion of the relative values of medication and cognitive-behavioral therapy. And unfortunately, meeting these behavioral guidelines can be difficult to achieve and cannot be subcontracted out to a therapist or a pharmacist. They require parents to set and enforce limits. Saying no is difficult for all of us, particularly those without much prior experience.

Have you observed the association between inadequate sleep, excessive screen time, and impulsivity? How robustly have you bought into the idea that more sleep and less screen time are, if not THE answers, at least are the two we should start with? Where do your recommendations about screen time, sleep, and physical activity fit into the script when you are talking with parents about their child’s ADHD-ish behaviors? Have you put them in the oh-by-the-way category?

Do you ever say, “I know you may be expecting me to talk about medication at this visit, but I suggest you try setting and enforcing these limits on sleep and screen time for a few months and we will see how things are going”? “And I am going to give you some suggestions on how you can do this, and we will meet again as often as you feel is necessary to ease the process.”

Do you think you have the time to try this approach? Do you feel you have the skills to counsel on sleep and behavior? Do you think you can find someone with the time and experience who shares your priorities about screen time and sleep to do the parental coaching for you? It’s an approach worth considering when you step back and take the longer look at why we are living through this decades-long ADHD phenomenon.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].