Are head-to-head cancer drug trials rigged?

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More than half of studies testing anticancer drugs against each other have rules with regard to dose modification and growth support that favor the experimental drug arm, a new analysis suggests.

“We found it sobering that this practice is so common,” Timothée Olivier, MD, with Geneva University Hospital and the University of California, San Francisco, said in an interview.

Trials may be “rigged” in a way where the new therapy appears more effective than if the trial would have been designed with fairer rules, he explained.

This leaves open the question of whether new drugs are truly superior to older ones or if instead different outcomes are caused by more aggressive dosing or growth factor support, the investigators said.

Dr. Olivier, with UCSF coinvestigators Alyson Haslam, PhD, and Vinay Prasad, MD, reported their findings online in the European Journal of Cancer.

‘Highly concerning’

Different drug modification rules or growth factor support guidance may affect the results of randomized controlled trials (RCTs) of testing new cancer agents.

For their study, Dr. Olivier and colleagues did a cross-sectional analysis of all 62 head-to-head registration RCTs that led to Food and Drug Administration approval between 2009 and 2021.

All of the trials examined anticancer drugs in the advanced or metastatic setting where a comparison was made between arms regarding either dose modification rules or myeloid growth factors recommendations.

The researchers assessed imbalance in drug modification rules, myeloid growth factor recommendations, or both, according to prespecified rules.

They discovered that 40 of the 62 trials (65%) had unequal rules for dose medication, granulocyte colony-stimulating factor (G-CSF) use, or both.

Six trials (10%) had rules favoring the control arm, while 34 (55%) had rules favoring the experimental arm. Among these, 50% had unequal drug modification rules, 41% had unequal G-CSF rules, and 9% had both.

Dr. Olivier said in an interview the results are “highly concerning because when you are investigating the effect of a new drug, you don’t want to have a false sense of a drug’s effect because of other factors not directly related to the drug’s efficacy.”

“If you introduce unfair rules about dose modification or supporting medication that favors the new drug, then you don’t know if a positive trial is due to the effect of the new drug or to the effect of differential dosing or supporting medication,” he added.
 

Blame industry?

Dr. Olivier said the fact that most registration trials are industry-sponsored is likely the primary explanation of the findings.

“Industry-sponsored trials may be designed so that the new drug has the best chance to get the largest ‘win,’ because this means more market share and more profit for the company that manufactures the drug. This is not a criticism of the industry, which runs on a business model that naturally aims to gain more market share and more profit,” Dr. Olivier said.

“However, it is the role and duty of regulators to reconcile industry incentives with the patients’ best interests, and there is accumulating data showing the regulators are failing to do so,” he added.

Addressing this problem will likely take buy-in from multiple stakeholders.

Awareness of the problem is a first step and understanding the influence of commercial incentives in drug development is also key, Dr. Olivier said.

Institutional review boards and drug regulators could also systematically evaluate drug dosing modification and supportive medication rules before a trial gets underway.

Regulators could also incentivize companies to implement balanced rules between arms by not granting drug approval based on trials suffering from such flaws.

“However, financial conflict of interest is present at many levels of drug development, including in drug regulation,” Dr. Olivier noted.

He pointed to a recent study that found when hematology-oncology medical reviewers working at the FDA leave the agency, more than half end up working or consulting for the pharmaceutical industry.

Dr. Olivier wondered: “How can one fairly and independently appraise a medical intervention if one’s current or future revenue depends on its source?”

The study was funded by Arnold Ventures, through a grant paid to UCSF. Dr. Olivier and Dr. Haslam had no relevant disclosures. Dr. Prasad reported receiving royalties from Arnold Ventures.

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

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More than half of studies testing anticancer drugs against each other have rules with regard to dose modification and growth support that favor the experimental drug arm, a new analysis suggests.

“We found it sobering that this practice is so common,” Timothée Olivier, MD, with Geneva University Hospital and the University of California, San Francisco, said in an interview.

Trials may be “rigged” in a way where the new therapy appears more effective than if the trial would have been designed with fairer rules, he explained.

This leaves open the question of whether new drugs are truly superior to older ones or if instead different outcomes are caused by more aggressive dosing or growth factor support, the investigators said.

Dr. Olivier, with UCSF coinvestigators Alyson Haslam, PhD, and Vinay Prasad, MD, reported their findings online in the European Journal of Cancer.

‘Highly concerning’

Different drug modification rules or growth factor support guidance may affect the results of randomized controlled trials (RCTs) of testing new cancer agents.

For their study, Dr. Olivier and colleagues did a cross-sectional analysis of all 62 head-to-head registration RCTs that led to Food and Drug Administration approval between 2009 and 2021.

All of the trials examined anticancer drugs in the advanced or metastatic setting where a comparison was made between arms regarding either dose modification rules or myeloid growth factors recommendations.

The researchers assessed imbalance in drug modification rules, myeloid growth factor recommendations, or both, according to prespecified rules.

They discovered that 40 of the 62 trials (65%) had unequal rules for dose medication, granulocyte colony-stimulating factor (G-CSF) use, or both.

Six trials (10%) had rules favoring the control arm, while 34 (55%) had rules favoring the experimental arm. Among these, 50% had unequal drug modification rules, 41% had unequal G-CSF rules, and 9% had both.

Dr. Olivier said in an interview the results are “highly concerning because when you are investigating the effect of a new drug, you don’t want to have a false sense of a drug’s effect because of other factors not directly related to the drug’s efficacy.”

“If you introduce unfair rules about dose modification or supporting medication that favors the new drug, then you don’t know if a positive trial is due to the effect of the new drug or to the effect of differential dosing or supporting medication,” he added.
 

Blame industry?

Dr. Olivier said the fact that most registration trials are industry-sponsored is likely the primary explanation of the findings.

“Industry-sponsored trials may be designed so that the new drug has the best chance to get the largest ‘win,’ because this means more market share and more profit for the company that manufactures the drug. This is not a criticism of the industry, which runs on a business model that naturally aims to gain more market share and more profit,” Dr. Olivier said.

“However, it is the role and duty of regulators to reconcile industry incentives with the patients’ best interests, and there is accumulating data showing the regulators are failing to do so,” he added.

Addressing this problem will likely take buy-in from multiple stakeholders.

Awareness of the problem is a first step and understanding the influence of commercial incentives in drug development is also key, Dr. Olivier said.

Institutional review boards and drug regulators could also systematically evaluate drug dosing modification and supportive medication rules before a trial gets underway.

Regulators could also incentivize companies to implement balanced rules between arms by not granting drug approval based on trials suffering from such flaws.

“However, financial conflict of interest is present at many levels of drug development, including in drug regulation,” Dr. Olivier noted.

He pointed to a recent study that found when hematology-oncology medical reviewers working at the FDA leave the agency, more than half end up working or consulting for the pharmaceutical industry.

Dr. Olivier wondered: “How can one fairly and independently appraise a medical intervention if one’s current or future revenue depends on its source?”

The study was funded by Arnold Ventures, through a grant paid to UCSF. Dr. Olivier and Dr. Haslam had no relevant disclosures. Dr. Prasad reported receiving royalties from Arnold Ventures.

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

More than half of studies testing anticancer drugs against each other have rules with regard to dose modification and growth support that favor the experimental drug arm, a new analysis suggests.

“We found it sobering that this practice is so common,” Timothée Olivier, MD, with Geneva University Hospital and the University of California, San Francisco, said in an interview.

Trials may be “rigged” in a way where the new therapy appears more effective than if the trial would have been designed with fairer rules, he explained.

This leaves open the question of whether new drugs are truly superior to older ones or if instead different outcomes are caused by more aggressive dosing or growth factor support, the investigators said.

Dr. Olivier, with UCSF coinvestigators Alyson Haslam, PhD, and Vinay Prasad, MD, reported their findings online in the European Journal of Cancer.

‘Highly concerning’

Different drug modification rules or growth factor support guidance may affect the results of randomized controlled trials (RCTs) of testing new cancer agents.

For their study, Dr. Olivier and colleagues did a cross-sectional analysis of all 62 head-to-head registration RCTs that led to Food and Drug Administration approval between 2009 and 2021.

All of the trials examined anticancer drugs in the advanced or metastatic setting where a comparison was made between arms regarding either dose modification rules or myeloid growth factors recommendations.

The researchers assessed imbalance in drug modification rules, myeloid growth factor recommendations, or both, according to prespecified rules.

They discovered that 40 of the 62 trials (65%) had unequal rules for dose medication, granulocyte colony-stimulating factor (G-CSF) use, or both.

Six trials (10%) had rules favoring the control arm, while 34 (55%) had rules favoring the experimental arm. Among these, 50% had unequal drug modification rules, 41% had unequal G-CSF rules, and 9% had both.

Dr. Olivier said in an interview the results are “highly concerning because when you are investigating the effect of a new drug, you don’t want to have a false sense of a drug’s effect because of other factors not directly related to the drug’s efficacy.”

“If you introduce unfair rules about dose modification or supporting medication that favors the new drug, then you don’t know if a positive trial is due to the effect of the new drug or to the effect of differential dosing or supporting medication,” he added.
 

Blame industry?

Dr. Olivier said the fact that most registration trials are industry-sponsored is likely the primary explanation of the findings.

“Industry-sponsored trials may be designed so that the new drug has the best chance to get the largest ‘win,’ because this means more market share and more profit for the company that manufactures the drug. This is not a criticism of the industry, which runs on a business model that naturally aims to gain more market share and more profit,” Dr. Olivier said.

“However, it is the role and duty of regulators to reconcile industry incentives with the patients’ best interests, and there is accumulating data showing the regulators are failing to do so,” he added.

Addressing this problem will likely take buy-in from multiple stakeholders.

Awareness of the problem is a first step and understanding the influence of commercial incentives in drug development is also key, Dr. Olivier said.

Institutional review boards and drug regulators could also systematically evaluate drug dosing modification and supportive medication rules before a trial gets underway.

Regulators could also incentivize companies to implement balanced rules between arms by not granting drug approval based on trials suffering from such flaws.

“However, financial conflict of interest is present at many levels of drug development, including in drug regulation,” Dr. Olivier noted.

He pointed to a recent study that found when hematology-oncology medical reviewers working at the FDA leave the agency, more than half end up working or consulting for the pharmaceutical industry.

Dr. Olivier wondered: “How can one fairly and independently appraise a medical intervention if one’s current or future revenue depends on its source?”

The study was funded by Arnold Ventures, through a grant paid to UCSF. Dr. Olivier and Dr. Haslam had no relevant disclosures. Dr. Prasad reported receiving royalties from Arnold Ventures.

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

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‘Ecotrauma’: The effects of climate change on mental health

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In June of this year, the World Health Organization launched a policy report to confront the increasingly strong and lasting impacts that climate change is having directly and indirectly on people’s mental health and psychosocial well-being.

In addition to the increasingly high incidence of mental disorders (for instance, emotional distress, stress, depression, and suicidal behavior) affecting people worldwide, the WHO warned of new, emerging syndromes that are directly related to climate change, such as “ecotrauma.” This term refers to anxiety in the face of the apocalyptic scenario predicted to result from the transformation of ecosystems by anthropogenic activity.

Two weeks after the release of the policy report, which integrates key policies for countries to address one of the biggest challenges, the WHO published its largest review of global mental health since the turn of the century. The work provides a model for governments, academics, health professionals, and civil society to become key players when dealing with the mental health problems that our society is going through.

Bernhard_Staehli/Thinkstock

As the document highlights, almost 1 billion people, including 14% of the world’s adolescents, were living with a mental health disorder in 2019. Suicide accounted for more than 1 in 100 deaths, and 58% of cases occurred before age 50 years. Mental health disorders are already the leading cause of disability in the world, and people with serious but preventable diseases die on average 10-20 years earlier than the general population.

The COVID-19 crisis has significantly aggravated mental health disorders, especially in populations such as minors. Consequently, many experts refer to this public health phenomenon as the new major pandemic. “I’m not sure it’s correct to call a set of mental health problems a pandemic, but the reality is that many countries are ignoring or largely forgetting this crisis,” Sarah Sheppard, WHO communications officer, told this news organization. According to Ms. Sheppard, “stigma and lack of understanding are key drivers of these problems and have been one of the reasons for the lack of mental health funding for decades. Mental health receives less than 1% of international health aid.” We recently interviewed Ms. Sheppard about these challenges.

Univadis: As the data provided in the recently released Mental Health and Climate Change Policy Brief indicate, there are large gaps in many countries between mental health needs and the services and systems available to address them. Where can we start to change this reality?

Ms. Sheppard: The simplest answer to improve the situation we face begins with a change in people’s priorities when it comes to valuing mental health. This would lead to greater investment in human and financial resources for mental health services and systems. However, the challenge lies in the complexity of the problem. In the report we just published, we provide comprehensive recommendations on how to transform mental health systems for all, such as trying to integrate climate change considerations into policies and programs for mental health or building on existing global commitments, including the Sustainable Development Goals (SDGs) or the Paris Agreement.

Univadis: Is there evidence that mental illnesses and disorders affect some populations more than others, such as women, for example?

Ms. Sheppard: The prevalence of mental disorders varies according to conditions and according to sex and age. In general, I don’t think we can say that mental health conditions or disorders affect women more than men. There are groups at risk, but vulnerability depends on the context and varies a lot. Of course, social determinants such as poverty, unstable housing, and exposure to adversity can significantly increase risk.

Univadis: According to the statistics recently provided by the WHO, changes in the environment are directly and indirectly affecting people’s mental health and psychosocial well-being. The new report highlights the gap between countries when it comes to addressing this complex problem. Is there any country that is carrying out political or innovative initiatives in this regard?

Ms. Sheppard: Yes, there are many case studies in the policy brief that highlight important work in the area. There are strong examples that are highlighted in the summary. One of them is India and its resilient cities program. Focused on the reduction of disaster risk, climate resilience, and mental health and psychosocial support at city level, this project resulted from a collaboration between the United Nations Development Program and the Indian National Institute of Mental Health and Neurosciences, which began in 2017.

Univadis: In addition to its effects on mental health, we are seeing how climate change is causing the appearance and resurgence of zoonoses, such as the pandemic caused by coronavirus and now monkeypox.

Ms. Sheppard: Mike Ryan, head of emergency situations at WHO, stated at the beginning of June that the increase in zoonoses raises the risk of new pandemics. Infections transmitted from animals to humans, such as Ebola, COVID-19, or monkeypox, have multiplied in recent years. Climate change alters the conditions for pathogens and zoonotic disease vectors and their distribution. The intensification of travel, for example, allows them to spread more quickly and in a more uncontrolled way.

Human health, including mental health, is connected to animal health. As various materials available to us from our World Health Day 2022 campaign examine, the links between planetary health and human health are inextricable.

Univadis: How is it possible that while scientific progress advances and more powerful and efficient technologies are developed, we become increasingly vulnerable to environmental phenomena?

Ms. Sheppard: Scientific advancement improves our understanding of the quality and scale of the health impacts of climate change, including the identification of the most vulnerable groups, as well as the adaptation and mitigation measures that would work to reduce the consequences on health. At the same time, climate change is widespread, rapid, and intensifying. Technological advances have a role to play in mitigation, particularly those tools that reduce our dependence on burning fossil fuels, as well as adaptation to climate change. For example, early warning systems for extreme weather events could reduce those vulnerabilities your question mentioned.

On the other hand, the measures proposed by the latest report on mental health and climate change have multiple effects. Some are particularly powerful and are not overly dependent on new technology. These include changing our mode of transport to low-emission, physically active ways to get around (walking, cycling), the benefits of which are already more than proven for both the environment and human health.

This article was translated from Univadis Spain.

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

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In June of this year, the World Health Organization launched a policy report to confront the increasingly strong and lasting impacts that climate change is having directly and indirectly on people’s mental health and psychosocial well-being.

In addition to the increasingly high incidence of mental disorders (for instance, emotional distress, stress, depression, and suicidal behavior) affecting people worldwide, the WHO warned of new, emerging syndromes that are directly related to climate change, such as “ecotrauma.” This term refers to anxiety in the face of the apocalyptic scenario predicted to result from the transformation of ecosystems by anthropogenic activity.

Two weeks after the release of the policy report, which integrates key policies for countries to address one of the biggest challenges, the WHO published its largest review of global mental health since the turn of the century. The work provides a model for governments, academics, health professionals, and civil society to become key players when dealing with the mental health problems that our society is going through.

Bernhard_Staehli/Thinkstock

As the document highlights, almost 1 billion people, including 14% of the world’s adolescents, were living with a mental health disorder in 2019. Suicide accounted for more than 1 in 100 deaths, and 58% of cases occurred before age 50 years. Mental health disorders are already the leading cause of disability in the world, and people with serious but preventable diseases die on average 10-20 years earlier than the general population.

The COVID-19 crisis has significantly aggravated mental health disorders, especially in populations such as minors. Consequently, many experts refer to this public health phenomenon as the new major pandemic. “I’m not sure it’s correct to call a set of mental health problems a pandemic, but the reality is that many countries are ignoring or largely forgetting this crisis,” Sarah Sheppard, WHO communications officer, told this news organization. According to Ms. Sheppard, “stigma and lack of understanding are key drivers of these problems and have been one of the reasons for the lack of mental health funding for decades. Mental health receives less than 1% of international health aid.” We recently interviewed Ms. Sheppard about these challenges.

Univadis: As the data provided in the recently released Mental Health and Climate Change Policy Brief indicate, there are large gaps in many countries between mental health needs and the services and systems available to address them. Where can we start to change this reality?

Ms. Sheppard: The simplest answer to improve the situation we face begins with a change in people’s priorities when it comes to valuing mental health. This would lead to greater investment in human and financial resources for mental health services and systems. However, the challenge lies in the complexity of the problem. In the report we just published, we provide comprehensive recommendations on how to transform mental health systems for all, such as trying to integrate climate change considerations into policies and programs for mental health or building on existing global commitments, including the Sustainable Development Goals (SDGs) or the Paris Agreement.

Univadis: Is there evidence that mental illnesses and disorders affect some populations more than others, such as women, for example?

Ms. Sheppard: The prevalence of mental disorders varies according to conditions and according to sex and age. In general, I don’t think we can say that mental health conditions or disorders affect women more than men. There are groups at risk, but vulnerability depends on the context and varies a lot. Of course, social determinants such as poverty, unstable housing, and exposure to adversity can significantly increase risk.

Univadis: According to the statistics recently provided by the WHO, changes in the environment are directly and indirectly affecting people’s mental health and psychosocial well-being. The new report highlights the gap between countries when it comes to addressing this complex problem. Is there any country that is carrying out political or innovative initiatives in this regard?

Ms. Sheppard: Yes, there are many case studies in the policy brief that highlight important work in the area. There are strong examples that are highlighted in the summary. One of them is India and its resilient cities program. Focused on the reduction of disaster risk, climate resilience, and mental health and psychosocial support at city level, this project resulted from a collaboration between the United Nations Development Program and the Indian National Institute of Mental Health and Neurosciences, which began in 2017.

Univadis: In addition to its effects on mental health, we are seeing how climate change is causing the appearance and resurgence of zoonoses, such as the pandemic caused by coronavirus and now monkeypox.

Ms. Sheppard: Mike Ryan, head of emergency situations at WHO, stated at the beginning of June that the increase in zoonoses raises the risk of new pandemics. Infections transmitted from animals to humans, such as Ebola, COVID-19, or monkeypox, have multiplied in recent years. Climate change alters the conditions for pathogens and zoonotic disease vectors and their distribution. The intensification of travel, for example, allows them to spread more quickly and in a more uncontrolled way.

Human health, including mental health, is connected to animal health. As various materials available to us from our World Health Day 2022 campaign examine, the links between planetary health and human health are inextricable.

Univadis: How is it possible that while scientific progress advances and more powerful and efficient technologies are developed, we become increasingly vulnerable to environmental phenomena?

Ms. Sheppard: Scientific advancement improves our understanding of the quality and scale of the health impacts of climate change, including the identification of the most vulnerable groups, as well as the adaptation and mitigation measures that would work to reduce the consequences on health. At the same time, climate change is widespread, rapid, and intensifying. Technological advances have a role to play in mitigation, particularly those tools that reduce our dependence on burning fossil fuels, as well as adaptation to climate change. For example, early warning systems for extreme weather events could reduce those vulnerabilities your question mentioned.

On the other hand, the measures proposed by the latest report on mental health and climate change have multiple effects. Some are particularly powerful and are not overly dependent on new technology. These include changing our mode of transport to low-emission, physically active ways to get around (walking, cycling), the benefits of which are already more than proven for both the environment and human health.

This article was translated from Univadis Spain.

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

In June of this year, the World Health Organization launched a policy report to confront the increasingly strong and lasting impacts that climate change is having directly and indirectly on people’s mental health and psychosocial well-being.

In addition to the increasingly high incidence of mental disorders (for instance, emotional distress, stress, depression, and suicidal behavior) affecting people worldwide, the WHO warned of new, emerging syndromes that are directly related to climate change, such as “ecotrauma.” This term refers to anxiety in the face of the apocalyptic scenario predicted to result from the transformation of ecosystems by anthropogenic activity.

Two weeks after the release of the policy report, which integrates key policies for countries to address one of the biggest challenges, the WHO published its largest review of global mental health since the turn of the century. The work provides a model for governments, academics, health professionals, and civil society to become key players when dealing with the mental health problems that our society is going through.

Bernhard_Staehli/Thinkstock

As the document highlights, almost 1 billion people, including 14% of the world’s adolescents, were living with a mental health disorder in 2019. Suicide accounted for more than 1 in 100 deaths, and 58% of cases occurred before age 50 years. Mental health disorders are already the leading cause of disability in the world, and people with serious but preventable diseases die on average 10-20 years earlier than the general population.

The COVID-19 crisis has significantly aggravated mental health disorders, especially in populations such as minors. Consequently, many experts refer to this public health phenomenon as the new major pandemic. “I’m not sure it’s correct to call a set of mental health problems a pandemic, but the reality is that many countries are ignoring or largely forgetting this crisis,” Sarah Sheppard, WHO communications officer, told this news organization. According to Ms. Sheppard, “stigma and lack of understanding are key drivers of these problems and have been one of the reasons for the lack of mental health funding for decades. Mental health receives less than 1% of international health aid.” We recently interviewed Ms. Sheppard about these challenges.

Univadis: As the data provided in the recently released Mental Health and Climate Change Policy Brief indicate, there are large gaps in many countries between mental health needs and the services and systems available to address them. Where can we start to change this reality?

Ms. Sheppard: The simplest answer to improve the situation we face begins with a change in people’s priorities when it comes to valuing mental health. This would lead to greater investment in human and financial resources for mental health services and systems. However, the challenge lies in the complexity of the problem. In the report we just published, we provide comprehensive recommendations on how to transform mental health systems for all, such as trying to integrate climate change considerations into policies and programs for mental health or building on existing global commitments, including the Sustainable Development Goals (SDGs) or the Paris Agreement.

Univadis: Is there evidence that mental illnesses and disorders affect some populations more than others, such as women, for example?

Ms. Sheppard: The prevalence of mental disorders varies according to conditions and according to sex and age. In general, I don’t think we can say that mental health conditions or disorders affect women more than men. There are groups at risk, but vulnerability depends on the context and varies a lot. Of course, social determinants such as poverty, unstable housing, and exposure to adversity can significantly increase risk.

Univadis: According to the statistics recently provided by the WHO, changes in the environment are directly and indirectly affecting people’s mental health and psychosocial well-being. The new report highlights the gap between countries when it comes to addressing this complex problem. Is there any country that is carrying out political or innovative initiatives in this regard?

Ms. Sheppard: Yes, there are many case studies in the policy brief that highlight important work in the area. There are strong examples that are highlighted in the summary. One of them is India and its resilient cities program. Focused on the reduction of disaster risk, climate resilience, and mental health and psychosocial support at city level, this project resulted from a collaboration between the United Nations Development Program and the Indian National Institute of Mental Health and Neurosciences, which began in 2017.

Univadis: In addition to its effects on mental health, we are seeing how climate change is causing the appearance and resurgence of zoonoses, such as the pandemic caused by coronavirus and now monkeypox.

Ms. Sheppard: Mike Ryan, head of emergency situations at WHO, stated at the beginning of June that the increase in zoonoses raises the risk of new pandemics. Infections transmitted from animals to humans, such as Ebola, COVID-19, or monkeypox, have multiplied in recent years. Climate change alters the conditions for pathogens and zoonotic disease vectors and their distribution. The intensification of travel, for example, allows them to spread more quickly and in a more uncontrolled way.

Human health, including mental health, is connected to animal health. As various materials available to us from our World Health Day 2022 campaign examine, the links between planetary health and human health are inextricable.

Univadis: How is it possible that while scientific progress advances and more powerful and efficient technologies are developed, we become increasingly vulnerable to environmental phenomena?

Ms. Sheppard: Scientific advancement improves our understanding of the quality and scale of the health impacts of climate change, including the identification of the most vulnerable groups, as well as the adaptation and mitigation measures that would work to reduce the consequences on health. At the same time, climate change is widespread, rapid, and intensifying. Technological advances have a role to play in mitigation, particularly those tools that reduce our dependence on burning fossil fuels, as well as adaptation to climate change. For example, early warning systems for extreme weather events could reduce those vulnerabilities your question mentioned.

On the other hand, the measures proposed by the latest report on mental health and climate change have multiple effects. Some are particularly powerful and are not overly dependent on new technology. These include changing our mode of transport to low-emission, physically active ways to get around (walking, cycling), the benefits of which are already more than proven for both the environment and human health.

This article was translated from Univadis Spain.

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

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How short can a ‘short workout’ really be?

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Some people thrive on hours-long runs and sweaty Peloton classes, but a much larger group of people lack the time, motivation, or ability for long workouts. Take, for example, those with chronic health conditions, limited mobility, prior negative fitness experiences, or the hopelessly overscheduled.

That doesn’t mean they have to forgo the physical and psychological benefits of exercise. In recent years, headlines have touted research on the benefits of a few minutes of physical activity. Not to mention the cottage fitness industry that has risen in response by promising physical transformations in X minutes a day (or less!).

What’s true? What’s too good to be true? Can short bursts of activity – 10 minutes or less – really help improve your health and fitness? Even when U.S. Health & Human Services physical activity guidelines recommend 150-300 minutes (2.5-5 hours) of moderate intensity movement per week?

The research says yes. While you should never expect total-body transformation, short workouts, even 10 minutes or less, really can improve your health, mental wellbeing, and fitness – if you approach them right.
 

Why short bursts of movement can be beneficial

Since at least 2005, researchers have been attempting to pinpoint just how short you can go and still benefit, says Edward F. Coyle, PhD, professor and director of the Human Performance Laboratory at the University of Texas, Austin.

Part of the equation is intensity. His studies show 10-minute workouts in which people cycle as hard as they can for 4 seconds, then rest for 15-30 seconds, improve fitness in young and older adults (and in the latter, also build muscle mass). Other studies have shown shorter “exercise snacks” – climbing three flights of stairs three times, with 1-4 hours in between – improved fitness over six weeks.

By turning up the intensity, Dr. Coyle says, these interval sessions temporarily deprive your muscles of both fuel and the oxygen they need to produce more, just like longer workouts. In response, your blood volume increases, your heart pumps more with each beat, and your muscle cells develop more mitochondria (tiny energy-producing factories).

That doesn’t mean less-intense physical activity isn’t beneficial, too. It is. In fact, there are several ways you can approach shorter movement sessions and really do well.

1. “Accumulate” a healthier lifestyle by moving throughout the day.

To reap the myriad benefits of physical activity – from lower blood pressure to better sleep to a longer life – health experts recommend the aforementioned 150 minutes of moderate-intensity aerobic activity weekly. Moderate means your heart’s beating faster, but you can still speak.

That averages out to 20 minutes daily. However, if you’ve been inactive or have physical or logistical limitations, a full 20 minutes can seem daunting.

Fortunately, the most recent update to the Physical Activity Guidelines for Americans specifically states you don’t have to log those minutes at once. Any amount of movement “counts” toward the total.

Four minutes here, 8 minutes there, another 5 minutes again later … it all adds up.

In fact, depending on what you do with the rest of your hours, small, frequent bouts of movement may be better for your health than one solid workout.

“Being very sedentary all day and just doing 30 minutes of exercise once a day is not very healthy for you,” says Anthony Wall, MS, a certified personal trainer and spokesperson for the American Council on Exercise. Emphasis on very sedentary. Long periods of sitting have their own health risks, including more heart disease and diabetes. While a single concentrated workout session is better than nothing, it may not reverse the damage done by all that sitting.

Remember: Our bodies are designed for movement. It’s okay to work up to 150 minutes gradually. Begin where you are, perhaps with a 5-minute walk around the block or easy stretches or exercises on the nearest patch of carpet. Establish consistency, then add on – it’ll feel easier as body and mind adapt.

“Data show the more you exercise, the more motivated you›ll be to exercise,” says Julia Basso, PhD, assistant professor and director of the embodied brain laboratory at Virginia Tech University, Blacksburg. When you crave movement, it’s easier to sneak it in. Eventually, all those minutes will add up to 150 a week – or more.

 

 

2. Improve mood and thinking as well as your health.

Short sessions of physical activity also benefit brain function, says Dr. Basso, a neuroscientist and dancer. Moving your body increases blood flow to the brain and modulates levels of neurotransmitters such as serotonin and dopamine. It also stimulates the release of growth factors that, over time, help sprout new brain cells.

And movement has near-immediate perks. In a recent Japanese study, running for just 10 minutes improved participant’s moods and reaction times on a color-word matching test. Brain imaging showed increased activity in prefrontal cortex areas that control executive functions such as attention, planning, and working memory.

So if you’re feeling low, stressed, or stuck on a tough problem at work, try a 10-minute break for moderate movement. In this case, don’t go all-out – tougher workouts still benefit your brain over time, but the immediate stress response may temporarily cloud your thinking, Dr. Basso says.

Instead, level up by adding another brain-boosting element like social connection or rhythmic music. Walk with a friend, for instance, or fire up a playlist and dance.

3. Gain fitness through brief, hard bursts.

The government’s exercise guidelines acknowledge the harder you work, the faster you reap rewards. Choosing more vigorous activities – where you›re breathing so hard you can only gasp a few words – halves the minimum requirement to 75 minutes weekly.

Plus, intensity brings added fitness gains, Mr. Wall says. This includes getting better at sport-specific skills and building anaerobic endurance, or the ability to work harder for longer periods of time.

However, the short, hard approach has its challenges. It’s often tricky to replicate lab-based protocols in the real world (Dr. Coyle’s cycling experiments, for example, use specialized bikes). Warming up first can add time; stair-climbing study participants began with 10 jumping jacks, 10 air squats, and five lunges on each leg.

Finally, pushing hard is uncomfortable. Doing it daily puts you at risk of overtraining or injury, Mr. Wall says. Even Dr. Coyle himself alternates 3 days per week of 4-second training with 45-minute steady rides, where he can watch Netflix.

Longer sessions bring more pronounced improvements in health markers like blood pressure and resting heart rate, Mr. Wall says. And while any movement is better than none, mixing up everything from modality to length and intensity likely provides the biggest bounty of benefits.

Consider these physical activity ideas “ingredients,” Mr. Wall says. “We all eat vegetables, but some of us like bell peppers more than carrots and tomatoes. We all need to get our five fruits and vegetables a day – but how we mix it up, there’s a lot of variation there. Movement works the same way.”

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

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Some people thrive on hours-long runs and sweaty Peloton classes, but a much larger group of people lack the time, motivation, or ability for long workouts. Take, for example, those with chronic health conditions, limited mobility, prior negative fitness experiences, or the hopelessly overscheduled.

That doesn’t mean they have to forgo the physical and psychological benefits of exercise. In recent years, headlines have touted research on the benefits of a few minutes of physical activity. Not to mention the cottage fitness industry that has risen in response by promising physical transformations in X minutes a day (or less!).

What’s true? What’s too good to be true? Can short bursts of activity – 10 minutes or less – really help improve your health and fitness? Even when U.S. Health & Human Services physical activity guidelines recommend 150-300 minutes (2.5-5 hours) of moderate intensity movement per week?

The research says yes. While you should never expect total-body transformation, short workouts, even 10 minutes or less, really can improve your health, mental wellbeing, and fitness – if you approach them right.
 

Why short bursts of movement can be beneficial

Since at least 2005, researchers have been attempting to pinpoint just how short you can go and still benefit, says Edward F. Coyle, PhD, professor and director of the Human Performance Laboratory at the University of Texas, Austin.

Part of the equation is intensity. His studies show 10-minute workouts in which people cycle as hard as they can for 4 seconds, then rest for 15-30 seconds, improve fitness in young and older adults (and in the latter, also build muscle mass). Other studies have shown shorter “exercise snacks” – climbing three flights of stairs three times, with 1-4 hours in between – improved fitness over six weeks.

By turning up the intensity, Dr. Coyle says, these interval sessions temporarily deprive your muscles of both fuel and the oxygen they need to produce more, just like longer workouts. In response, your blood volume increases, your heart pumps more with each beat, and your muscle cells develop more mitochondria (tiny energy-producing factories).

That doesn’t mean less-intense physical activity isn’t beneficial, too. It is. In fact, there are several ways you can approach shorter movement sessions and really do well.

1. “Accumulate” a healthier lifestyle by moving throughout the day.

To reap the myriad benefits of physical activity – from lower blood pressure to better sleep to a longer life – health experts recommend the aforementioned 150 minutes of moderate-intensity aerobic activity weekly. Moderate means your heart’s beating faster, but you can still speak.

That averages out to 20 minutes daily. However, if you’ve been inactive or have physical or logistical limitations, a full 20 minutes can seem daunting.

Fortunately, the most recent update to the Physical Activity Guidelines for Americans specifically states you don’t have to log those minutes at once. Any amount of movement “counts” toward the total.

Four minutes here, 8 minutes there, another 5 minutes again later … it all adds up.

In fact, depending on what you do with the rest of your hours, small, frequent bouts of movement may be better for your health than one solid workout.

“Being very sedentary all day and just doing 30 minutes of exercise once a day is not very healthy for you,” says Anthony Wall, MS, a certified personal trainer and spokesperson for the American Council on Exercise. Emphasis on very sedentary. Long periods of sitting have their own health risks, including more heart disease and diabetes. While a single concentrated workout session is better than nothing, it may not reverse the damage done by all that sitting.

Remember: Our bodies are designed for movement. It’s okay to work up to 150 minutes gradually. Begin where you are, perhaps with a 5-minute walk around the block or easy stretches or exercises on the nearest patch of carpet. Establish consistency, then add on – it’ll feel easier as body and mind adapt.

“Data show the more you exercise, the more motivated you›ll be to exercise,” says Julia Basso, PhD, assistant professor and director of the embodied brain laboratory at Virginia Tech University, Blacksburg. When you crave movement, it’s easier to sneak it in. Eventually, all those minutes will add up to 150 a week – or more.

 

 

2. Improve mood and thinking as well as your health.

Short sessions of physical activity also benefit brain function, says Dr. Basso, a neuroscientist and dancer. Moving your body increases blood flow to the brain and modulates levels of neurotransmitters such as serotonin and dopamine. It also stimulates the release of growth factors that, over time, help sprout new brain cells.

And movement has near-immediate perks. In a recent Japanese study, running for just 10 minutes improved participant’s moods and reaction times on a color-word matching test. Brain imaging showed increased activity in prefrontal cortex areas that control executive functions such as attention, planning, and working memory.

So if you’re feeling low, stressed, or stuck on a tough problem at work, try a 10-minute break for moderate movement. In this case, don’t go all-out – tougher workouts still benefit your brain over time, but the immediate stress response may temporarily cloud your thinking, Dr. Basso says.

Instead, level up by adding another brain-boosting element like social connection or rhythmic music. Walk with a friend, for instance, or fire up a playlist and dance.

3. Gain fitness through brief, hard bursts.

The government’s exercise guidelines acknowledge the harder you work, the faster you reap rewards. Choosing more vigorous activities – where you›re breathing so hard you can only gasp a few words – halves the minimum requirement to 75 minutes weekly.

Plus, intensity brings added fitness gains, Mr. Wall says. This includes getting better at sport-specific skills and building anaerobic endurance, or the ability to work harder for longer periods of time.

However, the short, hard approach has its challenges. It’s often tricky to replicate lab-based protocols in the real world (Dr. Coyle’s cycling experiments, for example, use specialized bikes). Warming up first can add time; stair-climbing study participants began with 10 jumping jacks, 10 air squats, and five lunges on each leg.

Finally, pushing hard is uncomfortable. Doing it daily puts you at risk of overtraining or injury, Mr. Wall says. Even Dr. Coyle himself alternates 3 days per week of 4-second training with 45-minute steady rides, where he can watch Netflix.

Longer sessions bring more pronounced improvements in health markers like blood pressure and resting heart rate, Mr. Wall says. And while any movement is better than none, mixing up everything from modality to length and intensity likely provides the biggest bounty of benefits.

Consider these physical activity ideas “ingredients,” Mr. Wall says. “We all eat vegetables, but some of us like bell peppers more than carrots and tomatoes. We all need to get our five fruits and vegetables a day – but how we mix it up, there’s a lot of variation there. Movement works the same way.”

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

Some people thrive on hours-long runs and sweaty Peloton classes, but a much larger group of people lack the time, motivation, or ability for long workouts. Take, for example, those with chronic health conditions, limited mobility, prior negative fitness experiences, or the hopelessly overscheduled.

That doesn’t mean they have to forgo the physical and psychological benefits of exercise. In recent years, headlines have touted research on the benefits of a few minutes of physical activity. Not to mention the cottage fitness industry that has risen in response by promising physical transformations in X minutes a day (or less!).

What’s true? What’s too good to be true? Can short bursts of activity – 10 minutes or less – really help improve your health and fitness? Even when U.S. Health & Human Services physical activity guidelines recommend 150-300 minutes (2.5-5 hours) of moderate intensity movement per week?

The research says yes. While you should never expect total-body transformation, short workouts, even 10 minutes or less, really can improve your health, mental wellbeing, and fitness – if you approach them right.
 

Why short bursts of movement can be beneficial

Since at least 2005, researchers have been attempting to pinpoint just how short you can go and still benefit, says Edward F. Coyle, PhD, professor and director of the Human Performance Laboratory at the University of Texas, Austin.

Part of the equation is intensity. His studies show 10-minute workouts in which people cycle as hard as they can for 4 seconds, then rest for 15-30 seconds, improve fitness in young and older adults (and in the latter, also build muscle mass). Other studies have shown shorter “exercise snacks” – climbing three flights of stairs three times, with 1-4 hours in between – improved fitness over six weeks.

By turning up the intensity, Dr. Coyle says, these interval sessions temporarily deprive your muscles of both fuel and the oxygen they need to produce more, just like longer workouts. In response, your blood volume increases, your heart pumps more with each beat, and your muscle cells develop more mitochondria (tiny energy-producing factories).

That doesn’t mean less-intense physical activity isn’t beneficial, too. It is. In fact, there are several ways you can approach shorter movement sessions and really do well.

1. “Accumulate” a healthier lifestyle by moving throughout the day.

To reap the myriad benefits of physical activity – from lower blood pressure to better sleep to a longer life – health experts recommend the aforementioned 150 minutes of moderate-intensity aerobic activity weekly. Moderate means your heart’s beating faster, but you can still speak.

That averages out to 20 minutes daily. However, if you’ve been inactive or have physical or logistical limitations, a full 20 minutes can seem daunting.

Fortunately, the most recent update to the Physical Activity Guidelines for Americans specifically states you don’t have to log those minutes at once. Any amount of movement “counts” toward the total.

Four minutes here, 8 minutes there, another 5 minutes again later … it all adds up.

In fact, depending on what you do with the rest of your hours, small, frequent bouts of movement may be better for your health than one solid workout.

“Being very sedentary all day and just doing 30 minutes of exercise once a day is not very healthy for you,” says Anthony Wall, MS, a certified personal trainer and spokesperson for the American Council on Exercise. Emphasis on very sedentary. Long periods of sitting have their own health risks, including more heart disease and diabetes. While a single concentrated workout session is better than nothing, it may not reverse the damage done by all that sitting.

Remember: Our bodies are designed for movement. It’s okay to work up to 150 minutes gradually. Begin where you are, perhaps with a 5-minute walk around the block or easy stretches or exercises on the nearest patch of carpet. Establish consistency, then add on – it’ll feel easier as body and mind adapt.

“Data show the more you exercise, the more motivated you›ll be to exercise,” says Julia Basso, PhD, assistant professor and director of the embodied brain laboratory at Virginia Tech University, Blacksburg. When you crave movement, it’s easier to sneak it in. Eventually, all those minutes will add up to 150 a week – or more.

 

 

2. Improve mood and thinking as well as your health.

Short sessions of physical activity also benefit brain function, says Dr. Basso, a neuroscientist and dancer. Moving your body increases blood flow to the brain and modulates levels of neurotransmitters such as serotonin and dopamine. It also stimulates the release of growth factors that, over time, help sprout new brain cells.

And movement has near-immediate perks. In a recent Japanese study, running for just 10 minutes improved participant’s moods and reaction times on a color-word matching test. Brain imaging showed increased activity in prefrontal cortex areas that control executive functions such as attention, planning, and working memory.

So if you’re feeling low, stressed, or stuck on a tough problem at work, try a 10-minute break for moderate movement. In this case, don’t go all-out – tougher workouts still benefit your brain over time, but the immediate stress response may temporarily cloud your thinking, Dr. Basso says.

Instead, level up by adding another brain-boosting element like social connection or rhythmic music. Walk with a friend, for instance, or fire up a playlist and dance.

3. Gain fitness through brief, hard bursts.

The government’s exercise guidelines acknowledge the harder you work, the faster you reap rewards. Choosing more vigorous activities – where you›re breathing so hard you can only gasp a few words – halves the minimum requirement to 75 minutes weekly.

Plus, intensity brings added fitness gains, Mr. Wall says. This includes getting better at sport-specific skills and building anaerobic endurance, or the ability to work harder for longer periods of time.

However, the short, hard approach has its challenges. It’s often tricky to replicate lab-based protocols in the real world (Dr. Coyle’s cycling experiments, for example, use specialized bikes). Warming up first can add time; stair-climbing study participants began with 10 jumping jacks, 10 air squats, and five lunges on each leg.

Finally, pushing hard is uncomfortable. Doing it daily puts you at risk of overtraining or injury, Mr. Wall says. Even Dr. Coyle himself alternates 3 days per week of 4-second training with 45-minute steady rides, where he can watch Netflix.

Longer sessions bring more pronounced improvements in health markers like blood pressure and resting heart rate, Mr. Wall says. And while any movement is better than none, mixing up everything from modality to length and intensity likely provides the biggest bounty of benefits.

Consider these physical activity ideas “ingredients,” Mr. Wall says. “We all eat vegetables, but some of us like bell peppers more than carrots and tomatoes. We all need to get our five fruits and vegetables a day – but how we mix it up, there’s a lot of variation there. Movement works the same way.”

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

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Charcoal could be the cure for the common high-fat diet

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Changed

 

Charcoal won’t let high-fat diet weigh you down

Do you want to be the funniest person alive? Of course you do. It’s really simple too, just one joke can make you the greatest comedian of all time. All you have to do is go camping and cook food over a roaring campfire. When someone drops food into the fire (which they always will), get ready. Once they fish out the offending food, which is almost certainly coated in hot coals, tell them: “Ah, eat it anyway. A little texture never hurt!” Trust us, most hilarious and original gag of all time.

But before your hapless friend brushes off his hot dog and forces a laugh, consider this: Japanese researchers have found that a charcoal supplement can prevent weight gain in mice consuming a high-fat diet. Charcoal is actually quite the helpful substance, and not just for grilling. It’s been used as medicine for hundreds of years and even today is used as a treatment for drug overdose and excess gas and flatulence.

PxHere

The study involved two groups of mice: One was fed a normal diet, the other a high-fat diet. After 12 weeks, the high-fat diet mice had gained weight. At that point, edible activated charcoal was added to their diet. From that point, weight gain was similar between the two groups, and the amount of bile acid, cholesterol, triglyceride, and fatty acid excreted by the high-fat mice increased by two to four times.

The researchers supported the notion that consuming an activated charcoal supplement before or while eating fatty food could prevent weight gain from said fatty food. Which works out well for the classic American barbecue, which is traditionally both high in fat and charcoal. All you have to do is buy some extra charcoal briquettes to pass around and munch on with your friends. Now that’s a party we can get behind.
 

There’s awake, and then there’s neurologically awake

Time to toss another urban legend onto the trash heap of history. Say goodbye to the benefits of uninterrupted sleep. It’s a fraud, a fake, a myth, a hit or myth, a swing and a myth, an old wives’ tale. You can stuff it and put it on a shelf next to Bigfoot, the Slender Man, and Twinkies.

JackF/thinkstockphotos.com

We all thought we needed 8 hours of uninterrupted sleep every night, but guess who we forgot to tell? Our brains. They’ve been doing exactly the opposite all along, laughing at us the whole time. Smug SOBs.

To straighten out this mess, let’s bring in a scientist, Celia Kjaerby of the Center for Translational Neuromedicine at the University of Copenhagen: “You may think that sleep is a constant state that you are in, and then you wake up. But there is a lot more to sleep than meets the eye. We have learned that noradrenaline causes you to wake up more than 100 times a night. And that is during perfectly normal sleep.”

Those 100 or so sleep interruptions are so brief that we don’t even notice, but they are very important, according to a study conducted at the university. Those tiny little wake-up calls are “the essence for the part of sleep that makes us wake up rested and which enables us to remember what we learned the day before. ... The very short awakenings are created by waves of norepinephrine [and they] reset the brain so that it is ready to store memory when you dive back into sleep,” lead author Maiken Nedergaard, MD, explained.

The investigators compared the level of noradrenaline in sleeping mice with their electrical activity and found that the hormone constantly increased and decreased in a wavelike pattern. A high level meant that the animal was neurologically awake. Deeper valleys between the high points meant better sleep, and the mice with the “highest number of deep noradrenaline valleys were also the ones with the best memory,” the team said in their written statement.

Not just the best memory, they said, but “super memory.” That, of course, was enough to get the attention of Marvel Comics, so the next Disney superhero blockbuster will feature Nocturna, the queen of the night. Her power? Never forgets. Her archnemesis? The Insomniac. Her catchphrase? “Let me sleep on it.”

 

Words can hurt, literally

Growing up, we’re sure you heard the “sticks and stones” rhyme. Maybe you’ve even recited it once or twice to defend yourself. Well, forget it, because words can hurt and your brain knows it.

PxHere

In a new study published in Frontiers in Communication, Marijn Struiksma, PhD, of Utrecht University, and colleagues incorporated the use of electroencephalography (EEG) and skin conductance on 79 women to see how words (specifically insults) actually affect the human body.

Each subject was asked to read three different types of statements: an insult, a compliment, and something factual but neutral. Half of the statements contained the subject’s name and half used somebody else’s. The participants were told that these statements were collected from three men.

Nobody interacted with each other, and the setting was completely clinical, yet the results were unmistakable. The EEG showed an effect in P2 amplitude with repetitive insults, no matter who it was about. Even though the insults weren’t real and the participants were aware of it, the brain still recognized them as hurtful, coming across as “mini slaps in the face,” Dr. Struiksma noted in a written statement.

The researchers noted that more needs to be done to better understand the long-term effects that insults can have and create a deeper understanding between words and emotion, but studying the effects of insults in a real-life setting is ethically tricky. This study is a start.

So, yeah, sticks and stones can break your bones, but words will actually hurt you.

This article was updated 7/21/22.

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Charcoal won’t let high-fat diet weigh you down

Do you want to be the funniest person alive? Of course you do. It’s really simple too, just one joke can make you the greatest comedian of all time. All you have to do is go camping and cook food over a roaring campfire. When someone drops food into the fire (which they always will), get ready. Once they fish out the offending food, which is almost certainly coated in hot coals, tell them: “Ah, eat it anyway. A little texture never hurt!” Trust us, most hilarious and original gag of all time.

But before your hapless friend brushes off his hot dog and forces a laugh, consider this: Japanese researchers have found that a charcoal supplement can prevent weight gain in mice consuming a high-fat diet. Charcoal is actually quite the helpful substance, and not just for grilling. It’s been used as medicine for hundreds of years and even today is used as a treatment for drug overdose and excess gas and flatulence.

PxHere

The study involved two groups of mice: One was fed a normal diet, the other a high-fat diet. After 12 weeks, the high-fat diet mice had gained weight. At that point, edible activated charcoal was added to their diet. From that point, weight gain was similar between the two groups, and the amount of bile acid, cholesterol, triglyceride, and fatty acid excreted by the high-fat mice increased by two to four times.

The researchers supported the notion that consuming an activated charcoal supplement before or while eating fatty food could prevent weight gain from said fatty food. Which works out well for the classic American barbecue, which is traditionally both high in fat and charcoal. All you have to do is buy some extra charcoal briquettes to pass around and munch on with your friends. Now that’s a party we can get behind.
 

There’s awake, and then there’s neurologically awake

Time to toss another urban legend onto the trash heap of history. Say goodbye to the benefits of uninterrupted sleep. It’s a fraud, a fake, a myth, a hit or myth, a swing and a myth, an old wives’ tale. You can stuff it and put it on a shelf next to Bigfoot, the Slender Man, and Twinkies.

JackF/thinkstockphotos.com

We all thought we needed 8 hours of uninterrupted sleep every night, but guess who we forgot to tell? Our brains. They’ve been doing exactly the opposite all along, laughing at us the whole time. Smug SOBs.

To straighten out this mess, let’s bring in a scientist, Celia Kjaerby of the Center for Translational Neuromedicine at the University of Copenhagen: “You may think that sleep is a constant state that you are in, and then you wake up. But there is a lot more to sleep than meets the eye. We have learned that noradrenaline causes you to wake up more than 100 times a night. And that is during perfectly normal sleep.”

Those 100 or so sleep interruptions are so brief that we don’t even notice, but they are very important, according to a study conducted at the university. Those tiny little wake-up calls are “the essence for the part of sleep that makes us wake up rested and which enables us to remember what we learned the day before. ... The very short awakenings are created by waves of norepinephrine [and they] reset the brain so that it is ready to store memory when you dive back into sleep,” lead author Maiken Nedergaard, MD, explained.

The investigators compared the level of noradrenaline in sleeping mice with their electrical activity and found that the hormone constantly increased and decreased in a wavelike pattern. A high level meant that the animal was neurologically awake. Deeper valleys between the high points meant better sleep, and the mice with the “highest number of deep noradrenaline valleys were also the ones with the best memory,” the team said in their written statement.

Not just the best memory, they said, but “super memory.” That, of course, was enough to get the attention of Marvel Comics, so the next Disney superhero blockbuster will feature Nocturna, the queen of the night. Her power? Never forgets. Her archnemesis? The Insomniac. Her catchphrase? “Let me sleep on it.”

 

Words can hurt, literally

Growing up, we’re sure you heard the “sticks and stones” rhyme. Maybe you’ve even recited it once or twice to defend yourself. Well, forget it, because words can hurt and your brain knows it.

PxHere

In a new study published in Frontiers in Communication, Marijn Struiksma, PhD, of Utrecht University, and colleagues incorporated the use of electroencephalography (EEG) and skin conductance on 79 women to see how words (specifically insults) actually affect the human body.

Each subject was asked to read three different types of statements: an insult, a compliment, and something factual but neutral. Half of the statements contained the subject’s name and half used somebody else’s. The participants were told that these statements were collected from three men.

Nobody interacted with each other, and the setting was completely clinical, yet the results were unmistakable. The EEG showed an effect in P2 amplitude with repetitive insults, no matter who it was about. Even though the insults weren’t real and the participants were aware of it, the brain still recognized them as hurtful, coming across as “mini slaps in the face,” Dr. Struiksma noted in a written statement.

The researchers noted that more needs to be done to better understand the long-term effects that insults can have and create a deeper understanding between words and emotion, but studying the effects of insults in a real-life setting is ethically tricky. This study is a start.

So, yeah, sticks and stones can break your bones, but words will actually hurt you.

This article was updated 7/21/22.

 

Charcoal won’t let high-fat diet weigh you down

Do you want to be the funniest person alive? Of course you do. It’s really simple too, just one joke can make you the greatest comedian of all time. All you have to do is go camping and cook food over a roaring campfire. When someone drops food into the fire (which they always will), get ready. Once they fish out the offending food, which is almost certainly coated in hot coals, tell them: “Ah, eat it anyway. A little texture never hurt!” Trust us, most hilarious and original gag of all time.

But before your hapless friend brushes off his hot dog and forces a laugh, consider this: Japanese researchers have found that a charcoal supplement can prevent weight gain in mice consuming a high-fat diet. Charcoal is actually quite the helpful substance, and not just for grilling. It’s been used as medicine for hundreds of years and even today is used as a treatment for drug overdose and excess gas and flatulence.

PxHere

The study involved two groups of mice: One was fed a normal diet, the other a high-fat diet. After 12 weeks, the high-fat diet mice had gained weight. At that point, edible activated charcoal was added to their diet. From that point, weight gain was similar between the two groups, and the amount of bile acid, cholesterol, triglyceride, and fatty acid excreted by the high-fat mice increased by two to four times.

The researchers supported the notion that consuming an activated charcoal supplement before or while eating fatty food could prevent weight gain from said fatty food. Which works out well for the classic American barbecue, which is traditionally both high in fat and charcoal. All you have to do is buy some extra charcoal briquettes to pass around and munch on with your friends. Now that’s a party we can get behind.
 

There’s awake, and then there’s neurologically awake

Time to toss another urban legend onto the trash heap of history. Say goodbye to the benefits of uninterrupted sleep. It’s a fraud, a fake, a myth, a hit or myth, a swing and a myth, an old wives’ tale. You can stuff it and put it on a shelf next to Bigfoot, the Slender Man, and Twinkies.

JackF/thinkstockphotos.com

We all thought we needed 8 hours of uninterrupted sleep every night, but guess who we forgot to tell? Our brains. They’ve been doing exactly the opposite all along, laughing at us the whole time. Smug SOBs.

To straighten out this mess, let’s bring in a scientist, Celia Kjaerby of the Center for Translational Neuromedicine at the University of Copenhagen: “You may think that sleep is a constant state that you are in, and then you wake up. But there is a lot more to sleep than meets the eye. We have learned that noradrenaline causes you to wake up more than 100 times a night. And that is during perfectly normal sleep.”

Those 100 or so sleep interruptions are so brief that we don’t even notice, but they are very important, according to a study conducted at the university. Those tiny little wake-up calls are “the essence for the part of sleep that makes us wake up rested and which enables us to remember what we learned the day before. ... The very short awakenings are created by waves of norepinephrine [and they] reset the brain so that it is ready to store memory when you dive back into sleep,” lead author Maiken Nedergaard, MD, explained.

The investigators compared the level of noradrenaline in sleeping mice with their electrical activity and found that the hormone constantly increased and decreased in a wavelike pattern. A high level meant that the animal was neurologically awake. Deeper valleys between the high points meant better sleep, and the mice with the “highest number of deep noradrenaline valleys were also the ones with the best memory,” the team said in their written statement.

Not just the best memory, they said, but “super memory.” That, of course, was enough to get the attention of Marvel Comics, so the next Disney superhero blockbuster will feature Nocturna, the queen of the night. Her power? Never forgets. Her archnemesis? The Insomniac. Her catchphrase? “Let me sleep on it.”

 

Words can hurt, literally

Growing up, we’re sure you heard the “sticks and stones” rhyme. Maybe you’ve even recited it once or twice to defend yourself. Well, forget it, because words can hurt and your brain knows it.

PxHere

In a new study published in Frontiers in Communication, Marijn Struiksma, PhD, of Utrecht University, and colleagues incorporated the use of electroencephalography (EEG) and skin conductance on 79 women to see how words (specifically insults) actually affect the human body.

Each subject was asked to read three different types of statements: an insult, a compliment, and something factual but neutral. Half of the statements contained the subject’s name and half used somebody else’s. The participants were told that these statements were collected from three men.

Nobody interacted with each other, and the setting was completely clinical, yet the results were unmistakable. The EEG showed an effect in P2 amplitude with repetitive insults, no matter who it was about. Even though the insults weren’t real and the participants were aware of it, the brain still recognized them as hurtful, coming across as “mini slaps in the face,” Dr. Struiksma noted in a written statement.

The researchers noted that more needs to be done to better understand the long-term effects that insults can have and create a deeper understanding between words and emotion, but studying the effects of insults in a real-life setting is ethically tricky. This study is a start.

So, yeah, sticks and stones can break your bones, but words will actually hurt you.

This article was updated 7/21/22.

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Statins linked to lower diabetes risk after acute pancreatitis

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Use of cholesterol-lowering statins was linked to a lower risk of developing a subtype of diabetes that occurs after acute pancreatitis, according to a new report.

The benefits of statins depended on the consistency of usage, with regular users having a lower risk of developing postpancreatitis diabetes than irregular users. The results were similar with low, moderate, and high statin doses, as well as in cases of both mild and severe acute pancreatitis.

“About 15% of patients with acute pancreatitis will develop diabetes mellitus in the next 5 years, and although we can monitor for it, we can’t do anything to prevent it,” Nikhil Thiruvengadam, MD, the lead study author and a gastroenterologist at Loma Linda (Calif.) University, told this news organization.

iStock/ThinkStock

“This could push you as a clinician to prescribe [a statin if you have a reason to] because it could provide two benefits instead of just one,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Steady use mattered, not dose

Patients with acute pancreatitis face at least a twofold increased risk of developing postpancreatitis diabetes, the study authors write. Although previous studies have shown that statins can lower the incidence and severity of acute pancreatitis, they haven’t been studied for the prevention of postpancreatitis diabetes.

In a collaborative study with several other universities, Dr. Thiruvengadam and colleagues examined commercial insurance claims from the Optum Clinformatics database to assess the impact of statins on 118,479 patients without preexisting diabetes admitted for a first episode of acute pancreatitis between 2008 and 2020.

They compared patients who consistently used statins with irregular users and nonusers. Regular statin usage was defined as patients who had statin prescriptions filled for at least 80% of the year prior to their acute pancreatitis diagnosis. The analysis included 9,048 patients (7.6%) who used statins regularly, 27,272 (23%) who used statins irregularly, and 82,159 (69.3%) nonusers.

With a median follow-up of 3.5 years, the 5-year cumulative incidence of postpancreatitis diabetes was 7.5% among regular statin users and 12.7% among nonusers. Regular statin users had a 42% lower risk of developing postpancreatitis diabetes, compared with nonusers. Irregular statin users had a 15% lower risk of postpancreatitis diabetes.

In addition, the 5-year cumulative incidence of insulin-dependent postpancreatitis diabetes was 2.4% among regular statin users and 6.6% among nonusers. Regular statin users had a 52% lower risk of developing insulin-dependent diabetes as compared with nonusers.

Daily dosage didn’t demonstrate a linear dose-response relationship. That means high-dose statins may not be more effective in preventing diabetes as compared with lower doses, the study authors write.

Statin usage was effective across additional analyses, including sex, etiologies of pancreatitis, and in both mild and severe acute pancreatitis. According to the study authors, this suggests that a broad population of these patients may benefit from statins.

“We were pleasantly surprised by the variety of findings,” Dr. Thiruvengadam said. “We’re seeing strong signals, especially with consistency of usage.”
 

Ongoing studies

The results may seem paradoxical, the study authors write, given an epidemiologic association with a slight increase in new-onset diabetes with statin initiation. But, as other researchers have reported, postpancreatitis diabetes and type 2 diabetes have different clinical features and underlying pathophysiology. For example, patients with postpancreatitis diabetes have much higher rates of requiring insulin, hospitalization, and all-cause mortality, the study authors write.

In fact, postpancreatitis diabetes is thought to be driven by chronic low-grade inflammation attributable to interleukin-6 and tumor necrosis factor–alpha. Statins have been shown to reduce tumor necrosis factor–alpha secretion and the production of C-reactive protein in response to circulating interleukin-6 in hepatocytes, they write.

The results should inform long-term prospective studies of acute pancreatitis, the study authors write, as well as randomized controlled trials of statins.

In the meantime, gastroenterologists and primary care physicians who see outpatients after hospitalization for acute pancreatitis may consider using statins, particularly in those who may have another possible indication for statin therapy, such as mild hyperlipidemia.

“There appears to be a low-dose benefit, which is another reason why providers may consider using statins, though it’s not for everyone with pancreatitis,” Dr. Thiruvengadam said. “This could be an exploratory pathway and suggested for use in the right setting.”

The Type 1 Diabetes in Acute Pancreatitis Consortium, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, is conducting an observational cohort study at more than a dozen locations across the country to investigate the incidence, etiology, and pathophysiology of diabetes after acute pancreatitis.

“Diabetes is surprisingly common after even a single attack of acute pancreatitis,” Chris Forsmark, MD, professor of medicine and chief of the division of gastroenterology, hepatology, and nutrition at the University of Florida, Gainesville, told this news organization.

Dr. Forsmark, who wasn’t involved with this study, is a member of T1DAPC and one of the principal investigators in Florida.

“The reduction of risk by 42% is quite substantial,” he said. “Like all such studies, there is risk of bias and confounding in determining the actual risk. Nonetheless, the results provide a strong reason for confirmation in other datasets and for further study.”

The study didn’t report funding support. Dr. Thiruvengadam and Dr. Forsmark report no relevant financial relationships.

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

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Use of cholesterol-lowering statins was linked to a lower risk of developing a subtype of diabetes that occurs after acute pancreatitis, according to a new report.

The benefits of statins depended on the consistency of usage, with regular users having a lower risk of developing postpancreatitis diabetes than irregular users. The results were similar with low, moderate, and high statin doses, as well as in cases of both mild and severe acute pancreatitis.

“About 15% of patients with acute pancreatitis will develop diabetes mellitus in the next 5 years, and although we can monitor for it, we can’t do anything to prevent it,” Nikhil Thiruvengadam, MD, the lead study author and a gastroenterologist at Loma Linda (Calif.) University, told this news organization.

iStock/ThinkStock

“This could push you as a clinician to prescribe [a statin if you have a reason to] because it could provide two benefits instead of just one,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Steady use mattered, not dose

Patients with acute pancreatitis face at least a twofold increased risk of developing postpancreatitis diabetes, the study authors write. Although previous studies have shown that statins can lower the incidence and severity of acute pancreatitis, they haven’t been studied for the prevention of postpancreatitis diabetes.

In a collaborative study with several other universities, Dr. Thiruvengadam and colleagues examined commercial insurance claims from the Optum Clinformatics database to assess the impact of statins on 118,479 patients without preexisting diabetes admitted for a first episode of acute pancreatitis between 2008 and 2020.

They compared patients who consistently used statins with irregular users and nonusers. Regular statin usage was defined as patients who had statin prescriptions filled for at least 80% of the year prior to their acute pancreatitis diagnosis. The analysis included 9,048 patients (7.6%) who used statins regularly, 27,272 (23%) who used statins irregularly, and 82,159 (69.3%) nonusers.

With a median follow-up of 3.5 years, the 5-year cumulative incidence of postpancreatitis diabetes was 7.5% among regular statin users and 12.7% among nonusers. Regular statin users had a 42% lower risk of developing postpancreatitis diabetes, compared with nonusers. Irregular statin users had a 15% lower risk of postpancreatitis diabetes.

In addition, the 5-year cumulative incidence of insulin-dependent postpancreatitis diabetes was 2.4% among regular statin users and 6.6% among nonusers. Regular statin users had a 52% lower risk of developing insulin-dependent diabetes as compared with nonusers.

Daily dosage didn’t demonstrate a linear dose-response relationship. That means high-dose statins may not be more effective in preventing diabetes as compared with lower doses, the study authors write.

Statin usage was effective across additional analyses, including sex, etiologies of pancreatitis, and in both mild and severe acute pancreatitis. According to the study authors, this suggests that a broad population of these patients may benefit from statins.

“We were pleasantly surprised by the variety of findings,” Dr. Thiruvengadam said. “We’re seeing strong signals, especially with consistency of usage.”
 

Ongoing studies

The results may seem paradoxical, the study authors write, given an epidemiologic association with a slight increase in new-onset diabetes with statin initiation. But, as other researchers have reported, postpancreatitis diabetes and type 2 diabetes have different clinical features and underlying pathophysiology. For example, patients with postpancreatitis diabetes have much higher rates of requiring insulin, hospitalization, and all-cause mortality, the study authors write.

In fact, postpancreatitis diabetes is thought to be driven by chronic low-grade inflammation attributable to interleukin-6 and tumor necrosis factor–alpha. Statins have been shown to reduce tumor necrosis factor–alpha secretion and the production of C-reactive protein in response to circulating interleukin-6 in hepatocytes, they write.

The results should inform long-term prospective studies of acute pancreatitis, the study authors write, as well as randomized controlled trials of statins.

In the meantime, gastroenterologists and primary care physicians who see outpatients after hospitalization for acute pancreatitis may consider using statins, particularly in those who may have another possible indication for statin therapy, such as mild hyperlipidemia.

“There appears to be a low-dose benefit, which is another reason why providers may consider using statins, though it’s not for everyone with pancreatitis,” Dr. Thiruvengadam said. “This could be an exploratory pathway and suggested for use in the right setting.”

The Type 1 Diabetes in Acute Pancreatitis Consortium, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, is conducting an observational cohort study at more than a dozen locations across the country to investigate the incidence, etiology, and pathophysiology of diabetes after acute pancreatitis.

“Diabetes is surprisingly common after even a single attack of acute pancreatitis,” Chris Forsmark, MD, professor of medicine and chief of the division of gastroenterology, hepatology, and nutrition at the University of Florida, Gainesville, told this news organization.

Dr. Forsmark, who wasn’t involved with this study, is a member of T1DAPC and one of the principal investigators in Florida.

“The reduction of risk by 42% is quite substantial,” he said. “Like all such studies, there is risk of bias and confounding in determining the actual risk. Nonetheless, the results provide a strong reason for confirmation in other datasets and for further study.”

The study didn’t report funding support. Dr. Thiruvengadam and Dr. Forsmark report no relevant financial relationships.

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

Use of cholesterol-lowering statins was linked to a lower risk of developing a subtype of diabetes that occurs after acute pancreatitis, according to a new report.

The benefits of statins depended on the consistency of usage, with regular users having a lower risk of developing postpancreatitis diabetes than irregular users. The results were similar with low, moderate, and high statin doses, as well as in cases of both mild and severe acute pancreatitis.

“About 15% of patients with acute pancreatitis will develop diabetes mellitus in the next 5 years, and although we can monitor for it, we can’t do anything to prevent it,” Nikhil Thiruvengadam, MD, the lead study author and a gastroenterologist at Loma Linda (Calif.) University, told this news organization.

iStock/ThinkStock

“This could push you as a clinician to prescribe [a statin if you have a reason to] because it could provide two benefits instead of just one,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Steady use mattered, not dose

Patients with acute pancreatitis face at least a twofold increased risk of developing postpancreatitis diabetes, the study authors write. Although previous studies have shown that statins can lower the incidence and severity of acute pancreatitis, they haven’t been studied for the prevention of postpancreatitis diabetes.

In a collaborative study with several other universities, Dr. Thiruvengadam and colleagues examined commercial insurance claims from the Optum Clinformatics database to assess the impact of statins on 118,479 patients without preexisting diabetes admitted for a first episode of acute pancreatitis between 2008 and 2020.

They compared patients who consistently used statins with irregular users and nonusers. Regular statin usage was defined as patients who had statin prescriptions filled for at least 80% of the year prior to their acute pancreatitis diagnosis. The analysis included 9,048 patients (7.6%) who used statins regularly, 27,272 (23%) who used statins irregularly, and 82,159 (69.3%) nonusers.

With a median follow-up of 3.5 years, the 5-year cumulative incidence of postpancreatitis diabetes was 7.5% among regular statin users and 12.7% among nonusers. Regular statin users had a 42% lower risk of developing postpancreatitis diabetes, compared with nonusers. Irregular statin users had a 15% lower risk of postpancreatitis diabetes.

In addition, the 5-year cumulative incidence of insulin-dependent postpancreatitis diabetes was 2.4% among regular statin users and 6.6% among nonusers. Regular statin users had a 52% lower risk of developing insulin-dependent diabetes as compared with nonusers.

Daily dosage didn’t demonstrate a linear dose-response relationship. That means high-dose statins may not be more effective in preventing diabetes as compared with lower doses, the study authors write.

Statin usage was effective across additional analyses, including sex, etiologies of pancreatitis, and in both mild and severe acute pancreatitis. According to the study authors, this suggests that a broad population of these patients may benefit from statins.

“We were pleasantly surprised by the variety of findings,” Dr. Thiruvengadam said. “We’re seeing strong signals, especially with consistency of usage.”
 

Ongoing studies

The results may seem paradoxical, the study authors write, given an epidemiologic association with a slight increase in new-onset diabetes with statin initiation. But, as other researchers have reported, postpancreatitis diabetes and type 2 diabetes have different clinical features and underlying pathophysiology. For example, patients with postpancreatitis diabetes have much higher rates of requiring insulin, hospitalization, and all-cause mortality, the study authors write.

In fact, postpancreatitis diabetes is thought to be driven by chronic low-grade inflammation attributable to interleukin-6 and tumor necrosis factor–alpha. Statins have been shown to reduce tumor necrosis factor–alpha secretion and the production of C-reactive protein in response to circulating interleukin-6 in hepatocytes, they write.

The results should inform long-term prospective studies of acute pancreatitis, the study authors write, as well as randomized controlled trials of statins.

In the meantime, gastroenterologists and primary care physicians who see outpatients after hospitalization for acute pancreatitis may consider using statins, particularly in those who may have another possible indication for statin therapy, such as mild hyperlipidemia.

“There appears to be a low-dose benefit, which is another reason why providers may consider using statins, though it’s not for everyone with pancreatitis,” Dr. Thiruvengadam said. “This could be an exploratory pathway and suggested for use in the right setting.”

The Type 1 Diabetes in Acute Pancreatitis Consortium, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases, is conducting an observational cohort study at more than a dozen locations across the country to investigate the incidence, etiology, and pathophysiology of diabetes after acute pancreatitis.

“Diabetes is surprisingly common after even a single attack of acute pancreatitis,” Chris Forsmark, MD, professor of medicine and chief of the division of gastroenterology, hepatology, and nutrition at the University of Florida, Gainesville, told this news organization.

Dr. Forsmark, who wasn’t involved with this study, is a member of T1DAPC and one of the principal investigators in Florida.

“The reduction of risk by 42% is quite substantial,” he said. “Like all such studies, there is risk of bias and confounding in determining the actual risk. Nonetheless, the results provide a strong reason for confirmation in other datasets and for further study.”

The study didn’t report funding support. Dr. Thiruvengadam and Dr. Forsmark report no relevant financial relationships.

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

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Alcohol’s detrimental impact on the brain explained?

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Iron accumulation in the brain as a result of alcohol consumption may explain why even moderate drinking is linked to compromised cognitive function.

Results of a large observational study suggest brain iron accumulation is a “plausible pathway” through which alcohol negatively affects cognition, study Anya Topiwala, MD, PhD, senior clinical researcher, Nuffield Department of Population Health, University of Oxford, England, said in an interview.

Study participants who drank 56 grams of alcohol a week had higher brain iron levels. The U.K. guideline for “low risk” alcohol consumption is less than 14 units weekly, or 112 grams.

“We are finding harmful associations with iron within those low-risk alcohol intake guidelines,” said Dr. Topiwala.

The study was published online  in PLOS Medicine.
 

Early intervention opportunity?

Previous research suggests higher brain iron may be involved in the pathophysiology of Alzheimer’s and Parkinson’s diseases. However, it’s unclear whether deposition plays a role in alcohol’s effect on the brain and if it does, whether this could present an opportunity for early intervention with, for example, chelating agents.

The study included 20,729 participants in the UK Biobank study, which recruited volunteers from 2006 to 2010. Participants had a mean age of 54.8 years, and 48.6% were female.

Participants self-identified as current, never, or previous alcohol consumers. For current drinkers, researchers calculated the total weekly number of U.K. units of alcohol consumed. One unit is 8 grams. A standard drink in the United States is 14 grams. They categorized weekly consumption into quintiles and used the lowest quintile as the reference category.

Participants underwent MRI to determine brain iron levels. Areas of interest were deep brain structures in the basal ganglia.

Mean weekly alcohol consumption was 17.7 units, which is higher than U.K. guidelines for low-risk consumption. “Half of the sample were drinking above what is recommended,” said Dr. Topiwala.

Alcohol consumption was associated with markers of higher iron in the bilateral putamen (beta, 0.08 standard deviation; 95% confidence interval, 0.06-0.09; P < .001), caudate (beta, 0.05; 95% CI, 0.04-0.07; P < .001), and substantia nigra (beta, 0.03; 95% CI; 0.02-0.05; P < .001).
 

Poorer performance

Drinking more than 7 units (56 grams) weekly was associated with higher susceptibility for all brain regions, except the thalamus.

Controlling for menopause status did not alter associations between alcohol and susceptibility for any brain region. This was also the case when excluding blood pressure and cholesterol as covariates.

There were significant interactions with age in the bilateral putamen and caudate but not with sex, smoking, or Townsend Deprivation Index, which includes such factors as unemployment and living conditions.

To gather data on liver iron levels, participants underwent abdominal imaging at the same time as brain imaging. Dr. Topiwala explained that the liver is a primary storage center for iron, so it was used as “a kind of surrogate marker” of iron in the body.

The researchers showed an indirect effect of alcohol through systemic iron. A 1 SD increase in weekly alcohol consumption was associated with a 0.05 mg/g (95% CI, 0.02-0.07; P < .001) increase in liver iron. In addition, a 1 mg/g increase in liver iron was associated with a 0.44 (95% CI, 0.35-0.52; P < .001) SD increase in left putamen susceptibility.

In this sample, 32% (95% CI, 22-49; P < .001) of alcohol’s total effect on left putamen susceptibility was mediated via higher systemic iron levels.

To minimize the impact of other factors influencing the association between alcohol consumption and brain iron – and the possibility that people with more brain iron drink more – researchers used Mendelian randomization that considers genetically predicted alcohol intake. This analysis supported findings of associations between alcohol consumption and brain iron.

Participants completed a cognitive battery, which included trail-making tests that reflect executive function, puzzle tests that assess fluid intelligence or logic and reasoning, and task-based tests using the “Snap” card game to measure reaction time.

Investigators found the more iron that was present in certain brain regions, the poorer participants’ cognitive performance.

Patients should know about the risks of moderate alcohol intake so they can make decisions about drinking, said Dr. Topiwala. “They should be aware that 14 units of alcohol per week is not a zero risk.”
 

 

 

Novel research

Commenting for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations, Alzheimer’s Association, noted the study’s large size as a strength of the research.

She noted previous research has shown an association between higher iron levels and alcohol dependence and worse cognitive function, but the potential connection of brain iron levels, moderate alcohol consumption, and cognition has not been studied to date.

“This paper aims to look at whether there is a potential biological link between moderate alcohol consumption and cognition through iron-related pathways.”

The authors suggest more work is needed to understand whether alcohol consumption impacts iron-related biologies to affect downstream cognition, said Dr. Snyder. “Although this study does not answer that question, it does highlight some important questions.”

Study authors received funding from Wellcome Trust, UK Medical Research Council, National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, BHF Centre of Research Excellence, British Heart Foundation, NIHR Cambridge Biomedical Research Centre, U.S. Department of Veterans Affairs, China Scholarship Council, and Li Ka Shing Centre for Health Information and Discovery. Dr. Topiwala has disclosed no relevant financial relationships.

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

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Iron accumulation in the brain as a result of alcohol consumption may explain why even moderate drinking is linked to compromised cognitive function.

Results of a large observational study suggest brain iron accumulation is a “plausible pathway” through which alcohol negatively affects cognition, study Anya Topiwala, MD, PhD, senior clinical researcher, Nuffield Department of Population Health, University of Oxford, England, said in an interview.

Study participants who drank 56 grams of alcohol a week had higher brain iron levels. The U.K. guideline for “low risk” alcohol consumption is less than 14 units weekly, or 112 grams.

“We are finding harmful associations with iron within those low-risk alcohol intake guidelines,” said Dr. Topiwala.

The study was published online  in PLOS Medicine.
 

Early intervention opportunity?

Previous research suggests higher brain iron may be involved in the pathophysiology of Alzheimer’s and Parkinson’s diseases. However, it’s unclear whether deposition plays a role in alcohol’s effect on the brain and if it does, whether this could present an opportunity for early intervention with, for example, chelating agents.

The study included 20,729 participants in the UK Biobank study, which recruited volunteers from 2006 to 2010. Participants had a mean age of 54.8 years, and 48.6% were female.

Participants self-identified as current, never, or previous alcohol consumers. For current drinkers, researchers calculated the total weekly number of U.K. units of alcohol consumed. One unit is 8 grams. A standard drink in the United States is 14 grams. They categorized weekly consumption into quintiles and used the lowest quintile as the reference category.

Participants underwent MRI to determine brain iron levels. Areas of interest were deep brain structures in the basal ganglia.

Mean weekly alcohol consumption was 17.7 units, which is higher than U.K. guidelines for low-risk consumption. “Half of the sample were drinking above what is recommended,” said Dr. Topiwala.

Alcohol consumption was associated with markers of higher iron in the bilateral putamen (beta, 0.08 standard deviation; 95% confidence interval, 0.06-0.09; P < .001), caudate (beta, 0.05; 95% CI, 0.04-0.07; P < .001), and substantia nigra (beta, 0.03; 95% CI; 0.02-0.05; P < .001).
 

Poorer performance

Drinking more than 7 units (56 grams) weekly was associated with higher susceptibility for all brain regions, except the thalamus.

Controlling for menopause status did not alter associations between alcohol and susceptibility for any brain region. This was also the case when excluding blood pressure and cholesterol as covariates.

There were significant interactions with age in the bilateral putamen and caudate but not with sex, smoking, or Townsend Deprivation Index, which includes such factors as unemployment and living conditions.

To gather data on liver iron levels, participants underwent abdominal imaging at the same time as brain imaging. Dr. Topiwala explained that the liver is a primary storage center for iron, so it was used as “a kind of surrogate marker” of iron in the body.

The researchers showed an indirect effect of alcohol through systemic iron. A 1 SD increase in weekly alcohol consumption was associated with a 0.05 mg/g (95% CI, 0.02-0.07; P < .001) increase in liver iron. In addition, a 1 mg/g increase in liver iron was associated with a 0.44 (95% CI, 0.35-0.52; P < .001) SD increase in left putamen susceptibility.

In this sample, 32% (95% CI, 22-49; P < .001) of alcohol’s total effect on left putamen susceptibility was mediated via higher systemic iron levels.

To minimize the impact of other factors influencing the association between alcohol consumption and brain iron – and the possibility that people with more brain iron drink more – researchers used Mendelian randomization that considers genetically predicted alcohol intake. This analysis supported findings of associations between alcohol consumption and brain iron.

Participants completed a cognitive battery, which included trail-making tests that reflect executive function, puzzle tests that assess fluid intelligence or logic and reasoning, and task-based tests using the “Snap” card game to measure reaction time.

Investigators found the more iron that was present in certain brain regions, the poorer participants’ cognitive performance.

Patients should know about the risks of moderate alcohol intake so they can make decisions about drinking, said Dr. Topiwala. “They should be aware that 14 units of alcohol per week is not a zero risk.”
 

 

 

Novel research

Commenting for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations, Alzheimer’s Association, noted the study’s large size as a strength of the research.

She noted previous research has shown an association between higher iron levels and alcohol dependence and worse cognitive function, but the potential connection of brain iron levels, moderate alcohol consumption, and cognition has not been studied to date.

“This paper aims to look at whether there is a potential biological link between moderate alcohol consumption and cognition through iron-related pathways.”

The authors suggest more work is needed to understand whether alcohol consumption impacts iron-related biologies to affect downstream cognition, said Dr. Snyder. “Although this study does not answer that question, it does highlight some important questions.”

Study authors received funding from Wellcome Trust, UK Medical Research Council, National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, BHF Centre of Research Excellence, British Heart Foundation, NIHR Cambridge Biomedical Research Centre, U.S. Department of Veterans Affairs, China Scholarship Council, and Li Ka Shing Centre for Health Information and Discovery. Dr. Topiwala has disclosed no relevant financial relationships.

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

Iron accumulation in the brain as a result of alcohol consumption may explain why even moderate drinking is linked to compromised cognitive function.

Results of a large observational study suggest brain iron accumulation is a “plausible pathway” through which alcohol negatively affects cognition, study Anya Topiwala, MD, PhD, senior clinical researcher, Nuffield Department of Population Health, University of Oxford, England, said in an interview.

Study participants who drank 56 grams of alcohol a week had higher brain iron levels. The U.K. guideline for “low risk” alcohol consumption is less than 14 units weekly, or 112 grams.

“We are finding harmful associations with iron within those low-risk alcohol intake guidelines,” said Dr. Topiwala.

The study was published online  in PLOS Medicine.
 

Early intervention opportunity?

Previous research suggests higher brain iron may be involved in the pathophysiology of Alzheimer’s and Parkinson’s diseases. However, it’s unclear whether deposition plays a role in alcohol’s effect on the brain and if it does, whether this could present an opportunity for early intervention with, for example, chelating agents.

The study included 20,729 participants in the UK Biobank study, which recruited volunteers from 2006 to 2010. Participants had a mean age of 54.8 years, and 48.6% were female.

Participants self-identified as current, never, or previous alcohol consumers. For current drinkers, researchers calculated the total weekly number of U.K. units of alcohol consumed. One unit is 8 grams. A standard drink in the United States is 14 grams. They categorized weekly consumption into quintiles and used the lowest quintile as the reference category.

Participants underwent MRI to determine brain iron levels. Areas of interest were deep brain structures in the basal ganglia.

Mean weekly alcohol consumption was 17.7 units, which is higher than U.K. guidelines for low-risk consumption. “Half of the sample were drinking above what is recommended,” said Dr. Topiwala.

Alcohol consumption was associated with markers of higher iron in the bilateral putamen (beta, 0.08 standard deviation; 95% confidence interval, 0.06-0.09; P < .001), caudate (beta, 0.05; 95% CI, 0.04-0.07; P < .001), and substantia nigra (beta, 0.03; 95% CI; 0.02-0.05; P < .001).
 

Poorer performance

Drinking more than 7 units (56 grams) weekly was associated with higher susceptibility for all brain regions, except the thalamus.

Controlling for menopause status did not alter associations between alcohol and susceptibility for any brain region. This was also the case when excluding blood pressure and cholesterol as covariates.

There were significant interactions with age in the bilateral putamen and caudate but not with sex, smoking, or Townsend Deprivation Index, which includes such factors as unemployment and living conditions.

To gather data on liver iron levels, participants underwent abdominal imaging at the same time as brain imaging. Dr. Topiwala explained that the liver is a primary storage center for iron, so it was used as “a kind of surrogate marker” of iron in the body.

The researchers showed an indirect effect of alcohol through systemic iron. A 1 SD increase in weekly alcohol consumption was associated with a 0.05 mg/g (95% CI, 0.02-0.07; P < .001) increase in liver iron. In addition, a 1 mg/g increase in liver iron was associated with a 0.44 (95% CI, 0.35-0.52; P < .001) SD increase in left putamen susceptibility.

In this sample, 32% (95% CI, 22-49; P < .001) of alcohol’s total effect on left putamen susceptibility was mediated via higher systemic iron levels.

To minimize the impact of other factors influencing the association between alcohol consumption and brain iron – and the possibility that people with more brain iron drink more – researchers used Mendelian randomization that considers genetically predicted alcohol intake. This analysis supported findings of associations between alcohol consumption and brain iron.

Participants completed a cognitive battery, which included trail-making tests that reflect executive function, puzzle tests that assess fluid intelligence or logic and reasoning, and task-based tests using the “Snap” card game to measure reaction time.

Investigators found the more iron that was present in certain brain regions, the poorer participants’ cognitive performance.

Patients should know about the risks of moderate alcohol intake so they can make decisions about drinking, said Dr. Topiwala. “They should be aware that 14 units of alcohol per week is not a zero risk.”
 

 

 

Novel research

Commenting for this news organization, Heather Snyder, PhD, vice president of medical and scientific relations, Alzheimer’s Association, noted the study’s large size as a strength of the research.

She noted previous research has shown an association between higher iron levels and alcohol dependence and worse cognitive function, but the potential connection of brain iron levels, moderate alcohol consumption, and cognition has not been studied to date.

“This paper aims to look at whether there is a potential biological link between moderate alcohol consumption and cognition through iron-related pathways.”

The authors suggest more work is needed to understand whether alcohol consumption impacts iron-related biologies to affect downstream cognition, said Dr. Snyder. “Although this study does not answer that question, it does highlight some important questions.”

Study authors received funding from Wellcome Trust, UK Medical Research Council, National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, BHF Centre of Research Excellence, British Heart Foundation, NIHR Cambridge Biomedical Research Centre, U.S. Department of Veterans Affairs, China Scholarship Council, and Li Ka Shing Centre for Health Information and Discovery. Dr. Topiwala has disclosed no relevant financial relationships.

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

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Violent patient throws scalding oil on MD; other patient dangers

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Ralph Newman, MD, got a taste of how dangerous medicine could be at age 10, when he witnessed a physician being shot by a patient.

“I was visiting a friend whose father was a psychiatrist,” Dr. Newman recalled. “We were playing in the living room when the doorbell rang. My friend went to the door and opened it. Then I heard a shot. I ran to the front hall and saw my friend’s father slumped at the bottom of the stairs. He had come down the stairs to see who was there. It was a patient armed with a shotgun.”

As a result of the shooting, a large portion of the psychiatrist’s intestines was removed. In spite of this traumatic incident, Dr. Newman went on to become a psychiatrist – who treated many violent prisoners. “I knew it was dangerous,” he said, “but I rationalized that I wouldn’t be attacked because I would be nicer.”

That attitude seemed to work until 2002, when a prisoner threw boiling oil on him. Dr. Newman was working at the Federal Medical Center Butner, a facility for prisoners in North Carolina. “A prisoner I had been treating was denied parole, based on my recommendation,” he said. “From then on, he was looking for a way to exact revenge.”

“One day I was sitting in the nursing station, typing up notes,” Dr. Newman said. “Two new nurses, who were also there, had forgotten to lock the door, and the prisoner noticed that. He heated up some baby oil in a microwave, which was available to prisoners at the time. Then he walked into the office, threw the oil on my back, and came at me with a sharp pencil.”

Dr. Newman said the nurses fled to an adjoining office, locked the door, and wouldn’t let him in. He went into another office and collapsed in exhaustion. He was saved by an inmate who came on the scene, fended off the attacker, and called for help.

“I was taken to the burn unit,” Dr. Newman recalled. “I had second- and third-degree burns on 9% of my body. It was extremely painful. It took me 45 days to recover enough to get back to work.” The two nurses were fired.
 

Doctors take threats by patients more seriously now

It is rare that patients murder their doctors, but when it happens, the news tears through the whole medical community. When orthopedic surgeon Preston Phillips, MD, was killed by a patient in Tulsa, Okla., on June 1, Jennifer M. Weiss, MD, recognized the potential danger to physicians.

“The news left me feeling very shaken,” said Dr. Weiss, a pediatric orthopedic surgeon at Southern California Permanente Medical Group, Los Angeles. “Every orthopedic surgeon I talked to about it felt shaken.”

Dr. Weiss said the impact of that event prompted her to take a patient’s abuse more seriously than she might have previously. “Before the killing, my colleagues and I might have swept the incident under the rug, but we reported it to the authorities,” she said.

“What happened was I told a parent of a school-aged child that the child wasn’t ready to go back to sports,” Dr. Weiss says. “This parent was incredibly triggered – screaming and making verbal threats. The parent was standing between me and the door, so I couldn’t get out.”

Coworkers down the hall heard the yelling and helped Dr. Weiss get out of the room. “The parent was escorted out of the building, and the incident was reported to our risk management team,” she said.
 

 

 

Shooters/killers vs. agitated patients

Patients who shoot to kill are very different from agitated patients seen by many doctors on a regular basis – particularly in emergency departments (EDs), psychiatric units, and pain clinics, said Scott Zeller, MD, a psychiatrist who is vice president of Acute Psychiatric Medicine at Vituity, a multistate physician partnership based in Emeryville, California.

“Agitated patients have trouble communicating their needs and can become physically and verbally aggressive,” Dr. Zeller said. He reports that there are 1.7 million such incidents a year in this country, but most of the incidents of verbal aggression can be kept from exploding into physical violence.

Shooters, however, are very hard to stop because they usually plan the action in advance, Dr. Zeller said. He recalled the 2017 murder of Todd Graham, MD, a friend from medical school. Dr. Graham, an orthopedic surgeon in South Bend, Ind., was gunned down by the husband of one of his patients after Dr. Graham declined to prescribe opioids for her.
 

Playing down the risk of violence

Doctors may play down the risk of violence, even after they have experienced it personally. “Patients can get angry and may make threatening comments,” Dr. Weiss said. “A lot of doctors just brush it off.”

Simple remarks can set off violence-prone patients, as happened to James P. Phillips, MD, director of disaster and operational medicine at George Washington University, Washington. He recalled asking a prisoner who was visiting his hospital to “lower the volume,” and the man exploded. “Even though he was handcuffed to the bed, he heaved an oxygen tank into a window,” Dr. Phillips said. “He said he would be coming back to kill me.”

Sometimes threats or other types of verbal abuse can be as destructive as physical violence. Diann Krywko, MD, an emergency physician at the Medical University of South Carolina (MUSC) Health, Charleston, has had some tough assignments. She worked in EDs in Detroit and Flint, Mich., for a decade before coming to MUSC, where she serves as director of wellness, health, and resilience. One of the incidents that has bothered her the most involved a threat.

It happened when Dr. Krywko denied a patient’s request for narcotics. “She was very angry and said she’d come to my home and cut my children’s heads off,” Dr. Krywko said. “To this day, what she said horrifies me. I still see her smile as she said that.”

Dr. Krywko considered filing for a restraining order against the patient but didn’t because the patient could have learned her address. Dr. Phillips said fear of retaliation is one reason many doctors don’t report threats from patients. “The patient you report knows where you work and may come there to take revenge,” he said. “Also, you may have to continue caring for the person who punched you.”

Online threats also may cause a great deal of angst. Dr. Phillips said he received many online threats when was a medical analyst for CNN in 2020. “Someone sent my address to his Twitter followers, and they shared it with others, so now the whole world knows where I live,” he said. “I had to upgrade security at my home.”
 

 

 

How to deal with volatile patients

Being nice may not always work, but in many cases, it can keep a volatile situation from exploding, according to Dr. Krywko.

“When patients begin to show signs of agitation or are already there, we always try to verbally deescalate the situation, which involves listening,” Dr. Krywko said. “They want someone to hear them out.”

Doctors speak to patients from a position of authority, but Dr. Krywko advises that they should not be too blunt. “Don’t tell patients they’re wrong,” she said. “Even if they may be incorrect, they feel their viewpoint is valid. Encourage a dialogue with words like, ‘Tell me more,’ ” Dr. Krywko said.
 

Defending yourself

Doctors may have little warning of an impending attack because a patient’s mood can change quickly. This happened several years ago to Jennifer Casaletto, MD, an emergency physician in Charlotte, N.C.

“A man was brought into my ED by ambulance,” she said. “He seemed very calm for a long while, but then he became completely unhinged. A male nurse placed himself between the patient and others and was attacked. He got hurt but was able to continue working.”

Dr. Zeller said health care teams sometimes overreact when patients lash out. “The old-fashioned way to deal with an agitated patient is to call in the cavalry – everyone does a group takedown,” he said. “The patient is put in restraints and heavily sedated. This is not good for anybody. Not only is it likely to injure and traumatize the patient, it can also injure the care team.”

Many hospital EDs have security guards. “I feel safer when a hospital has armed security guards, but they need to be well trained,” Dr. Casaletto said. “Many small hospitals and freestanding EDs do not have security officers at all, or the guards are undertrained or told not to touch anybody.”

In many electronic health record systems, doctors can flag violent patients so future caregivers can be forewarned. However, Dr. Zeller advises against writing about patients’ violence or rudeness in the medical record, because patients can have access to it and might take revenge.
 

Rising violence from patients

“It feels like it has become much more dangerous to work in the ED,” said Hasan Gokal, MD, an emergency physician working in EDs at the Texas Medical Center. “Just last week, a woman pulled out a gun and fired it in an ED near Houston.”

The statistics back up Dr. Gokal’s assessment. Injuries caused by violent attacks against medical professionals grew by 67% from 2011 to 2018, according to the U.S. Bureau of Labor Statistics. Those levels rose even more during the COVID-19 pandemic – the assault rate in hospitals rose 23% just in 2020.

Dr. Krywko said she had “a patient who said she wanted to hurt the next person who irritated her, and that happened to me. She jumped out of her bed swinging and punching, and I wasn’t ready for it. I yelled for help and the care team came.”

“The rise in violence has to do with a decline in respect for authority,” Dr. Phillips said. “Some people now believe doctors are lying to them about the need for COVID precautions because they are taking money from the vaccine companies. The pandemic has exacerbated violence in every way.”

Dr. Phillips said that a growing lack of resources had led to more anger among patients. “There are fewer nurses and reduced physician coverage,” he said. “That means longer wait times for patients, which increases patients’ frustrations.”

Dr. Weiss said patients have higher expectations. “In sports medicine, the expectations are incredible,” she said. “Parents want their kids to get back to playing as soon as possible.”

“Hospitals in particular are soft targets for violence,” Dr. Phillips said. “People know you can’t assault a flight attendant, because it’s a federal offense, but there is no such federal offense for violence against health care personnel.”

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

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Ralph Newman, MD, got a taste of how dangerous medicine could be at age 10, when he witnessed a physician being shot by a patient.

“I was visiting a friend whose father was a psychiatrist,” Dr. Newman recalled. “We were playing in the living room when the doorbell rang. My friend went to the door and opened it. Then I heard a shot. I ran to the front hall and saw my friend’s father slumped at the bottom of the stairs. He had come down the stairs to see who was there. It was a patient armed with a shotgun.”

As a result of the shooting, a large portion of the psychiatrist’s intestines was removed. In spite of this traumatic incident, Dr. Newman went on to become a psychiatrist – who treated many violent prisoners. “I knew it was dangerous,” he said, “but I rationalized that I wouldn’t be attacked because I would be nicer.”

That attitude seemed to work until 2002, when a prisoner threw boiling oil on him. Dr. Newman was working at the Federal Medical Center Butner, a facility for prisoners in North Carolina. “A prisoner I had been treating was denied parole, based on my recommendation,” he said. “From then on, he was looking for a way to exact revenge.”

“One day I was sitting in the nursing station, typing up notes,” Dr. Newman said. “Two new nurses, who were also there, had forgotten to lock the door, and the prisoner noticed that. He heated up some baby oil in a microwave, which was available to prisoners at the time. Then he walked into the office, threw the oil on my back, and came at me with a sharp pencil.”

Dr. Newman said the nurses fled to an adjoining office, locked the door, and wouldn’t let him in. He went into another office and collapsed in exhaustion. He was saved by an inmate who came on the scene, fended off the attacker, and called for help.

“I was taken to the burn unit,” Dr. Newman recalled. “I had second- and third-degree burns on 9% of my body. It was extremely painful. It took me 45 days to recover enough to get back to work.” The two nurses were fired.
 

Doctors take threats by patients more seriously now

It is rare that patients murder their doctors, but when it happens, the news tears through the whole medical community. When orthopedic surgeon Preston Phillips, MD, was killed by a patient in Tulsa, Okla., on June 1, Jennifer M. Weiss, MD, recognized the potential danger to physicians.

“The news left me feeling very shaken,” said Dr. Weiss, a pediatric orthopedic surgeon at Southern California Permanente Medical Group, Los Angeles. “Every orthopedic surgeon I talked to about it felt shaken.”

Dr. Weiss said the impact of that event prompted her to take a patient’s abuse more seriously than she might have previously. “Before the killing, my colleagues and I might have swept the incident under the rug, but we reported it to the authorities,” she said.

“What happened was I told a parent of a school-aged child that the child wasn’t ready to go back to sports,” Dr. Weiss says. “This parent was incredibly triggered – screaming and making verbal threats. The parent was standing between me and the door, so I couldn’t get out.”

Coworkers down the hall heard the yelling and helped Dr. Weiss get out of the room. “The parent was escorted out of the building, and the incident was reported to our risk management team,” she said.
 

 

 

Shooters/killers vs. agitated patients

Patients who shoot to kill are very different from agitated patients seen by many doctors on a regular basis – particularly in emergency departments (EDs), psychiatric units, and pain clinics, said Scott Zeller, MD, a psychiatrist who is vice president of Acute Psychiatric Medicine at Vituity, a multistate physician partnership based in Emeryville, California.

“Agitated patients have trouble communicating their needs and can become physically and verbally aggressive,” Dr. Zeller said. He reports that there are 1.7 million such incidents a year in this country, but most of the incidents of verbal aggression can be kept from exploding into physical violence.

Shooters, however, are very hard to stop because they usually plan the action in advance, Dr. Zeller said. He recalled the 2017 murder of Todd Graham, MD, a friend from medical school. Dr. Graham, an orthopedic surgeon in South Bend, Ind., was gunned down by the husband of one of his patients after Dr. Graham declined to prescribe opioids for her.
 

Playing down the risk of violence

Doctors may play down the risk of violence, even after they have experienced it personally. “Patients can get angry and may make threatening comments,” Dr. Weiss said. “A lot of doctors just brush it off.”

Simple remarks can set off violence-prone patients, as happened to James P. Phillips, MD, director of disaster and operational medicine at George Washington University, Washington. He recalled asking a prisoner who was visiting his hospital to “lower the volume,” and the man exploded. “Even though he was handcuffed to the bed, he heaved an oxygen tank into a window,” Dr. Phillips said. “He said he would be coming back to kill me.”

Sometimes threats or other types of verbal abuse can be as destructive as physical violence. Diann Krywko, MD, an emergency physician at the Medical University of South Carolina (MUSC) Health, Charleston, has had some tough assignments. She worked in EDs in Detroit and Flint, Mich., for a decade before coming to MUSC, where she serves as director of wellness, health, and resilience. One of the incidents that has bothered her the most involved a threat.

It happened when Dr. Krywko denied a patient’s request for narcotics. “She was very angry and said she’d come to my home and cut my children’s heads off,” Dr. Krywko said. “To this day, what she said horrifies me. I still see her smile as she said that.”

Dr. Krywko considered filing for a restraining order against the patient but didn’t because the patient could have learned her address. Dr. Phillips said fear of retaliation is one reason many doctors don’t report threats from patients. “The patient you report knows where you work and may come there to take revenge,” he said. “Also, you may have to continue caring for the person who punched you.”

Online threats also may cause a great deal of angst. Dr. Phillips said he received many online threats when was a medical analyst for CNN in 2020. “Someone sent my address to his Twitter followers, and they shared it with others, so now the whole world knows where I live,” he said. “I had to upgrade security at my home.”
 

 

 

How to deal with volatile patients

Being nice may not always work, but in many cases, it can keep a volatile situation from exploding, according to Dr. Krywko.

“When patients begin to show signs of agitation or are already there, we always try to verbally deescalate the situation, which involves listening,” Dr. Krywko said. “They want someone to hear them out.”

Doctors speak to patients from a position of authority, but Dr. Krywko advises that they should not be too blunt. “Don’t tell patients they’re wrong,” she said. “Even if they may be incorrect, they feel their viewpoint is valid. Encourage a dialogue with words like, ‘Tell me more,’ ” Dr. Krywko said.
 

Defending yourself

Doctors may have little warning of an impending attack because a patient’s mood can change quickly. This happened several years ago to Jennifer Casaletto, MD, an emergency physician in Charlotte, N.C.

“A man was brought into my ED by ambulance,” she said. “He seemed very calm for a long while, but then he became completely unhinged. A male nurse placed himself between the patient and others and was attacked. He got hurt but was able to continue working.”

Dr. Zeller said health care teams sometimes overreact when patients lash out. “The old-fashioned way to deal with an agitated patient is to call in the cavalry – everyone does a group takedown,” he said. “The patient is put in restraints and heavily sedated. This is not good for anybody. Not only is it likely to injure and traumatize the patient, it can also injure the care team.”

Many hospital EDs have security guards. “I feel safer when a hospital has armed security guards, but they need to be well trained,” Dr. Casaletto said. “Many small hospitals and freestanding EDs do not have security officers at all, or the guards are undertrained or told not to touch anybody.”

In many electronic health record systems, doctors can flag violent patients so future caregivers can be forewarned. However, Dr. Zeller advises against writing about patients’ violence or rudeness in the medical record, because patients can have access to it and might take revenge.
 

Rising violence from patients

“It feels like it has become much more dangerous to work in the ED,” said Hasan Gokal, MD, an emergency physician working in EDs at the Texas Medical Center. “Just last week, a woman pulled out a gun and fired it in an ED near Houston.”

The statistics back up Dr. Gokal’s assessment. Injuries caused by violent attacks against medical professionals grew by 67% from 2011 to 2018, according to the U.S. Bureau of Labor Statistics. Those levels rose even more during the COVID-19 pandemic – the assault rate in hospitals rose 23% just in 2020.

Dr. Krywko said she had “a patient who said she wanted to hurt the next person who irritated her, and that happened to me. She jumped out of her bed swinging and punching, and I wasn’t ready for it. I yelled for help and the care team came.”

“The rise in violence has to do with a decline in respect for authority,” Dr. Phillips said. “Some people now believe doctors are lying to them about the need for COVID precautions because they are taking money from the vaccine companies. The pandemic has exacerbated violence in every way.”

Dr. Phillips said that a growing lack of resources had led to more anger among patients. “There are fewer nurses and reduced physician coverage,” he said. “That means longer wait times for patients, which increases patients’ frustrations.”

Dr. Weiss said patients have higher expectations. “In sports medicine, the expectations are incredible,” she said. “Parents want their kids to get back to playing as soon as possible.”

“Hospitals in particular are soft targets for violence,” Dr. Phillips said. “People know you can’t assault a flight attendant, because it’s a federal offense, but there is no such federal offense for violence against health care personnel.”

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

Ralph Newman, MD, got a taste of how dangerous medicine could be at age 10, when he witnessed a physician being shot by a patient.

“I was visiting a friend whose father was a psychiatrist,” Dr. Newman recalled. “We were playing in the living room when the doorbell rang. My friend went to the door and opened it. Then I heard a shot. I ran to the front hall and saw my friend’s father slumped at the bottom of the stairs. He had come down the stairs to see who was there. It was a patient armed with a shotgun.”

As a result of the shooting, a large portion of the psychiatrist’s intestines was removed. In spite of this traumatic incident, Dr. Newman went on to become a psychiatrist – who treated many violent prisoners. “I knew it was dangerous,” he said, “but I rationalized that I wouldn’t be attacked because I would be nicer.”

That attitude seemed to work until 2002, when a prisoner threw boiling oil on him. Dr. Newman was working at the Federal Medical Center Butner, a facility for prisoners in North Carolina. “A prisoner I had been treating was denied parole, based on my recommendation,” he said. “From then on, he was looking for a way to exact revenge.”

“One day I was sitting in the nursing station, typing up notes,” Dr. Newman said. “Two new nurses, who were also there, had forgotten to lock the door, and the prisoner noticed that. He heated up some baby oil in a microwave, which was available to prisoners at the time. Then he walked into the office, threw the oil on my back, and came at me with a sharp pencil.”

Dr. Newman said the nurses fled to an adjoining office, locked the door, and wouldn’t let him in. He went into another office and collapsed in exhaustion. He was saved by an inmate who came on the scene, fended off the attacker, and called for help.

“I was taken to the burn unit,” Dr. Newman recalled. “I had second- and third-degree burns on 9% of my body. It was extremely painful. It took me 45 days to recover enough to get back to work.” The two nurses were fired.
 

Doctors take threats by patients more seriously now

It is rare that patients murder their doctors, but when it happens, the news tears through the whole medical community. When orthopedic surgeon Preston Phillips, MD, was killed by a patient in Tulsa, Okla., on June 1, Jennifer M. Weiss, MD, recognized the potential danger to physicians.

“The news left me feeling very shaken,” said Dr. Weiss, a pediatric orthopedic surgeon at Southern California Permanente Medical Group, Los Angeles. “Every orthopedic surgeon I talked to about it felt shaken.”

Dr. Weiss said the impact of that event prompted her to take a patient’s abuse more seriously than she might have previously. “Before the killing, my colleagues and I might have swept the incident under the rug, but we reported it to the authorities,” she said.

“What happened was I told a parent of a school-aged child that the child wasn’t ready to go back to sports,” Dr. Weiss says. “This parent was incredibly triggered – screaming and making verbal threats. The parent was standing between me and the door, so I couldn’t get out.”

Coworkers down the hall heard the yelling and helped Dr. Weiss get out of the room. “The parent was escorted out of the building, and the incident was reported to our risk management team,” she said.
 

 

 

Shooters/killers vs. agitated patients

Patients who shoot to kill are very different from agitated patients seen by many doctors on a regular basis – particularly in emergency departments (EDs), psychiatric units, and pain clinics, said Scott Zeller, MD, a psychiatrist who is vice president of Acute Psychiatric Medicine at Vituity, a multistate physician partnership based in Emeryville, California.

“Agitated patients have trouble communicating their needs and can become physically and verbally aggressive,” Dr. Zeller said. He reports that there are 1.7 million such incidents a year in this country, but most of the incidents of verbal aggression can be kept from exploding into physical violence.

Shooters, however, are very hard to stop because they usually plan the action in advance, Dr. Zeller said. He recalled the 2017 murder of Todd Graham, MD, a friend from medical school. Dr. Graham, an orthopedic surgeon in South Bend, Ind., was gunned down by the husband of one of his patients after Dr. Graham declined to prescribe opioids for her.
 

Playing down the risk of violence

Doctors may play down the risk of violence, even after they have experienced it personally. “Patients can get angry and may make threatening comments,” Dr. Weiss said. “A lot of doctors just brush it off.”

Simple remarks can set off violence-prone patients, as happened to James P. Phillips, MD, director of disaster and operational medicine at George Washington University, Washington. He recalled asking a prisoner who was visiting his hospital to “lower the volume,” and the man exploded. “Even though he was handcuffed to the bed, he heaved an oxygen tank into a window,” Dr. Phillips said. “He said he would be coming back to kill me.”

Sometimes threats or other types of verbal abuse can be as destructive as physical violence. Diann Krywko, MD, an emergency physician at the Medical University of South Carolina (MUSC) Health, Charleston, has had some tough assignments. She worked in EDs in Detroit and Flint, Mich., for a decade before coming to MUSC, where she serves as director of wellness, health, and resilience. One of the incidents that has bothered her the most involved a threat.

It happened when Dr. Krywko denied a patient’s request for narcotics. “She was very angry and said she’d come to my home and cut my children’s heads off,” Dr. Krywko said. “To this day, what she said horrifies me. I still see her smile as she said that.”

Dr. Krywko considered filing for a restraining order against the patient but didn’t because the patient could have learned her address. Dr. Phillips said fear of retaliation is one reason many doctors don’t report threats from patients. “The patient you report knows where you work and may come there to take revenge,” he said. “Also, you may have to continue caring for the person who punched you.”

Online threats also may cause a great deal of angst. Dr. Phillips said he received many online threats when was a medical analyst for CNN in 2020. “Someone sent my address to his Twitter followers, and they shared it with others, so now the whole world knows where I live,” he said. “I had to upgrade security at my home.”
 

 

 

How to deal with volatile patients

Being nice may not always work, but in many cases, it can keep a volatile situation from exploding, according to Dr. Krywko.

“When patients begin to show signs of agitation or are already there, we always try to verbally deescalate the situation, which involves listening,” Dr. Krywko said. “They want someone to hear them out.”

Doctors speak to patients from a position of authority, but Dr. Krywko advises that they should not be too blunt. “Don’t tell patients they’re wrong,” she said. “Even if they may be incorrect, they feel their viewpoint is valid. Encourage a dialogue with words like, ‘Tell me more,’ ” Dr. Krywko said.
 

Defending yourself

Doctors may have little warning of an impending attack because a patient’s mood can change quickly. This happened several years ago to Jennifer Casaletto, MD, an emergency physician in Charlotte, N.C.

“A man was brought into my ED by ambulance,” she said. “He seemed very calm for a long while, but then he became completely unhinged. A male nurse placed himself between the patient and others and was attacked. He got hurt but was able to continue working.”

Dr. Zeller said health care teams sometimes overreact when patients lash out. “The old-fashioned way to deal with an agitated patient is to call in the cavalry – everyone does a group takedown,” he said. “The patient is put in restraints and heavily sedated. This is not good for anybody. Not only is it likely to injure and traumatize the patient, it can also injure the care team.”

Many hospital EDs have security guards. “I feel safer when a hospital has armed security guards, but they need to be well trained,” Dr. Casaletto said. “Many small hospitals and freestanding EDs do not have security officers at all, or the guards are undertrained or told not to touch anybody.”

In many electronic health record systems, doctors can flag violent patients so future caregivers can be forewarned. However, Dr. Zeller advises against writing about patients’ violence or rudeness in the medical record, because patients can have access to it and might take revenge.
 

Rising violence from patients

“It feels like it has become much more dangerous to work in the ED,” said Hasan Gokal, MD, an emergency physician working in EDs at the Texas Medical Center. “Just last week, a woman pulled out a gun and fired it in an ED near Houston.”

The statistics back up Dr. Gokal’s assessment. Injuries caused by violent attacks against medical professionals grew by 67% from 2011 to 2018, according to the U.S. Bureau of Labor Statistics. Those levels rose even more during the COVID-19 pandemic – the assault rate in hospitals rose 23% just in 2020.

Dr. Krywko said she had “a patient who said she wanted to hurt the next person who irritated her, and that happened to me. She jumped out of her bed swinging and punching, and I wasn’t ready for it. I yelled for help and the care team came.”

“The rise in violence has to do with a decline in respect for authority,” Dr. Phillips said. “Some people now believe doctors are lying to them about the need for COVID precautions because they are taking money from the vaccine companies. The pandemic has exacerbated violence in every way.”

Dr. Phillips said that a growing lack of resources had led to more anger among patients. “There are fewer nurses and reduced physician coverage,” he said. “That means longer wait times for patients, which increases patients’ frustrations.”

Dr. Weiss said patients have higher expectations. “In sports medicine, the expectations are incredible,” she said. “Parents want their kids to get back to playing as soon as possible.”

“Hospitals in particular are soft targets for violence,” Dr. Phillips said. “People know you can’t assault a flight attendant, because it’s a federal offense, but there is no such federal offense for violence against health care personnel.”

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

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Drug shortages plague hematology, but preparedness helps

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Just before he took a call from a reporter asking about the impact of drug shortages in hematology, Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, had spent an hour on the phone overseeing his institution’s response to a hematology drug shortage. The chemotherapy drug fludarabine, used to treat chronic lymphocytic leukemia, was in short supply.

“There are 5 different manufacturers, but none of them have had drug available over the past 2 weeks,” Dr. Greene said. “We’re trying to chase some emergency supplies to be able to continue treatment for patients who’ve had their treatments initiated and planned.”

Over the past several years, this predicament has become common at hematology clinics across the country. In fact, management of scarce medication resources has become a significant part of Dr. Greene’s workload these days, as critical drugs fail to show up on time or manufacturer supplies run low at his hospital in Memphis.

This shortage of hematology drugs got a new dose of national attention, thanks to a recent episode of CBS News’ “60 Minutes.” Through interviews with physicians and parents of children who suddenly could not get vital medications, the report highlighted the recent shortage of another leukemia drug, vincristine.

“As a cancer mom, we shouldn’t be fighting for our children to get a drug that is needed,” Cyndi Valenta was quoted as saying. She recalled that when the shortage began in 2019, her 13-year-old son, a leukemia patient at Loma Linda (Calif.) University Hospital, felt frightened. Ms. Valenta said she felt a “gut-wrenching feeling of just fear and anger.” They were finally able to get doses of the drug after launching a social media campaign.

Such drug shortages are especially widespread in oncology and hematology, according to a survey of oncology pharmacists at 68 organizations nationwide. Published in the May 2022 issue of Oncology Practice, the study showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

The pharmacists surveyed between May 2019 and July 2020 were asked about the three most hard-to-get chemotherapy and supportive care agents. Vincristine topped the list, followed by vinblastine, IVIG, leucovorin, and BCG, as well as difficult-to-obtain ropine, erwinia asparaginase, etoposide, and leuprolide. Several of these drugs are used to treat conditions such as lymphoma and leukemia.

Eighty-two percent of respondents reported shortages of decitabine (IV), often used as part of a cocktail with vinblastine and other drugs to treat Hodgkin lymphoma.

The reasons for drug shortages are varied. The CBS News report declared that “pharmaceutical companies have stopped producing many life-saving generic drugs because they make too little profit,” and it suggested that the federal government isn’t doing enough.

But government action actually might be making a difference. According to the FDA, the number of new drug shortages has fallen dramatically from 250 in 2011 to 41 in 2021, and the number of prevented drug shortages rose from nearly 200 to more than 300 over that same period. Still, the number of ongoing drug shortages has risen from around 40 in 2017 to about 80 in 2021.

Reasons for the paucity of certain drugs are often unclear. In a June 12, 2022 post, for example, the American Society of Health-System Pharmacists’ drug shortage database noted that the chemotherapy drug fludarabine was in short supply and provided details about when some of the 5 manufacturers expected to have it available. (This is the shortage that Dr. Greene was trying to manage.) But 4 of the 5 manufacturers “did not provide a reason,” and the fifth blamed manufacturing delays.

“There’s a lot of closely held trade secrets that hinder the ability to share good information,” said Dr. Greene. To make things more complicated, shipping times are often unreliable. “The product doesn’t show up today, we place another order. Sometimes it will show up tomorrow, sometimes it doesn’t,” he said. “If you’re not tracking it carefully, you deplete your own supply.”

Patients’ families have grown used to dealing with drug shortages, and “they’re less quick to blame personnel at our institution.”

How can hematologists cope with this issue? “The best thing in the immediate term is to advocate for their hospital to have a pharmacist dedicated to shortage monitoring and taking proactive steps to obviate shortages,” hematologist/oncologist Andrew Hantel, MD, an instructor at Dana-Farber Cancer Institute, Harvard Medical School, Boston, said in an interview.

“We have ongoing communications with other large cancer centers and the FDA to recognize shortages early and develop plans to make sure we stay ahead of them,” Dr. Hantel said. “Most often this involves assessing supply, use rates, alternative manufacturers, and additional measures the Food and Drug Administration can take (for example, importation), and occasionally working with clinical teams to see if other medications are feasible alternatives.”

If a drug is unavailable, it can also be helpful to discuss alternative approaches. “We did not have any frank shortages of vincristine,” Dr. Hantel said, “but we did focus on conservation measures and considered different ethically appropriate ways to distribute vincristine if there was a point at which we did not have enough for everyone who needed it.”

If a drug is in short supply, options can include delaying treatment, giving an alternative, or providing the rest of the regimen without the scarce drug, he said. In a 2021 report in The Lancet Hematology, Dr. Hantel and his colleagues offered “model solutions for ethical allocation during cancer medicine shortages.”

The authors of the May 2022 drug-shortage report highlighted an alternative regimen in hematology. They noted that manufacturing delays have limited the supply of dacarbazine, used for Hodgkin lymphoma. Due to the current shortages, they wrote, clinicians are considering the use of escalated bleomycin, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, replacing dacarbazine with procarbazine and using the doxorubicin, bleomycin, vinblastine, procarbazine, and prednisone regimen, or replacing dacarbazine with cyclophosphamide.

Dr. Greene emphasized the importance of tracking the news and the drug shortage websites run by the FDA and the American Society of Health-System Pharmacists.

It’s also crucial to have a good relationship with your wholesaler, he added, and to communicate about these problems within your facility. At his hospital, the pharmaceutical staff holds a multi-disciplinary meeting at least weekly to discuss the supply of medications. As he put it, “it’s a challenging environment.”

Dr. Greene and Dr. Hantel reported no relevant disclosures.

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Just before he took a call from a reporter asking about the impact of drug shortages in hematology, Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, had spent an hour on the phone overseeing his institution’s response to a hematology drug shortage. The chemotherapy drug fludarabine, used to treat chronic lymphocytic leukemia, was in short supply.

“There are 5 different manufacturers, but none of them have had drug available over the past 2 weeks,” Dr. Greene said. “We’re trying to chase some emergency supplies to be able to continue treatment for patients who’ve had their treatments initiated and planned.”

Over the past several years, this predicament has become common at hematology clinics across the country. In fact, management of scarce medication resources has become a significant part of Dr. Greene’s workload these days, as critical drugs fail to show up on time or manufacturer supplies run low at his hospital in Memphis.

This shortage of hematology drugs got a new dose of national attention, thanks to a recent episode of CBS News’ “60 Minutes.” Through interviews with physicians and parents of children who suddenly could not get vital medications, the report highlighted the recent shortage of another leukemia drug, vincristine.

“As a cancer mom, we shouldn’t be fighting for our children to get a drug that is needed,” Cyndi Valenta was quoted as saying. She recalled that when the shortage began in 2019, her 13-year-old son, a leukemia patient at Loma Linda (Calif.) University Hospital, felt frightened. Ms. Valenta said she felt a “gut-wrenching feeling of just fear and anger.” They were finally able to get doses of the drug after launching a social media campaign.

Such drug shortages are especially widespread in oncology and hematology, according to a survey of oncology pharmacists at 68 organizations nationwide. Published in the May 2022 issue of Oncology Practice, the study showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

The pharmacists surveyed between May 2019 and July 2020 were asked about the three most hard-to-get chemotherapy and supportive care agents. Vincristine topped the list, followed by vinblastine, IVIG, leucovorin, and BCG, as well as difficult-to-obtain ropine, erwinia asparaginase, etoposide, and leuprolide. Several of these drugs are used to treat conditions such as lymphoma and leukemia.

Eighty-two percent of respondents reported shortages of decitabine (IV), often used as part of a cocktail with vinblastine and other drugs to treat Hodgkin lymphoma.

The reasons for drug shortages are varied. The CBS News report declared that “pharmaceutical companies have stopped producing many life-saving generic drugs because they make too little profit,” and it suggested that the federal government isn’t doing enough.

But government action actually might be making a difference. According to the FDA, the number of new drug shortages has fallen dramatically from 250 in 2011 to 41 in 2021, and the number of prevented drug shortages rose from nearly 200 to more than 300 over that same period. Still, the number of ongoing drug shortages has risen from around 40 in 2017 to about 80 in 2021.

Reasons for the paucity of certain drugs are often unclear. In a June 12, 2022 post, for example, the American Society of Health-System Pharmacists’ drug shortage database noted that the chemotherapy drug fludarabine was in short supply and provided details about when some of the 5 manufacturers expected to have it available. (This is the shortage that Dr. Greene was trying to manage.) But 4 of the 5 manufacturers “did not provide a reason,” and the fifth blamed manufacturing delays.

“There’s a lot of closely held trade secrets that hinder the ability to share good information,” said Dr. Greene. To make things more complicated, shipping times are often unreliable. “The product doesn’t show up today, we place another order. Sometimes it will show up tomorrow, sometimes it doesn’t,” he said. “If you’re not tracking it carefully, you deplete your own supply.”

Patients’ families have grown used to dealing with drug shortages, and “they’re less quick to blame personnel at our institution.”

How can hematologists cope with this issue? “The best thing in the immediate term is to advocate for their hospital to have a pharmacist dedicated to shortage monitoring and taking proactive steps to obviate shortages,” hematologist/oncologist Andrew Hantel, MD, an instructor at Dana-Farber Cancer Institute, Harvard Medical School, Boston, said in an interview.

“We have ongoing communications with other large cancer centers and the FDA to recognize shortages early and develop plans to make sure we stay ahead of them,” Dr. Hantel said. “Most often this involves assessing supply, use rates, alternative manufacturers, and additional measures the Food and Drug Administration can take (for example, importation), and occasionally working with clinical teams to see if other medications are feasible alternatives.”

If a drug is unavailable, it can also be helpful to discuss alternative approaches. “We did not have any frank shortages of vincristine,” Dr. Hantel said, “but we did focus on conservation measures and considered different ethically appropriate ways to distribute vincristine if there was a point at which we did not have enough for everyone who needed it.”

If a drug is in short supply, options can include delaying treatment, giving an alternative, or providing the rest of the regimen without the scarce drug, he said. In a 2021 report in The Lancet Hematology, Dr. Hantel and his colleagues offered “model solutions for ethical allocation during cancer medicine shortages.”

The authors of the May 2022 drug-shortage report highlighted an alternative regimen in hematology. They noted that manufacturing delays have limited the supply of dacarbazine, used for Hodgkin lymphoma. Due to the current shortages, they wrote, clinicians are considering the use of escalated bleomycin, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, replacing dacarbazine with procarbazine and using the doxorubicin, bleomycin, vinblastine, procarbazine, and prednisone regimen, or replacing dacarbazine with cyclophosphamide.

Dr. Greene emphasized the importance of tracking the news and the drug shortage websites run by the FDA and the American Society of Health-System Pharmacists.

It’s also crucial to have a good relationship with your wholesaler, he added, and to communicate about these problems within your facility. At his hospital, the pharmaceutical staff holds a multi-disciplinary meeting at least weekly to discuss the supply of medications. As he put it, “it’s a challenging environment.”

Dr. Greene and Dr. Hantel reported no relevant disclosures.

Just before he took a call from a reporter asking about the impact of drug shortages in hematology, Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, had spent an hour on the phone overseeing his institution’s response to a hematology drug shortage. The chemotherapy drug fludarabine, used to treat chronic lymphocytic leukemia, was in short supply.

“There are 5 different manufacturers, but none of them have had drug available over the past 2 weeks,” Dr. Greene said. “We’re trying to chase some emergency supplies to be able to continue treatment for patients who’ve had their treatments initiated and planned.”

Over the past several years, this predicament has become common at hematology clinics across the country. In fact, management of scarce medication resources has become a significant part of Dr. Greene’s workload these days, as critical drugs fail to show up on time or manufacturer supplies run low at his hospital in Memphis.

This shortage of hematology drugs got a new dose of national attention, thanks to a recent episode of CBS News’ “60 Minutes.” Through interviews with physicians and parents of children who suddenly could not get vital medications, the report highlighted the recent shortage of another leukemia drug, vincristine.

“As a cancer mom, we shouldn’t be fighting for our children to get a drug that is needed,” Cyndi Valenta was quoted as saying. She recalled that when the shortage began in 2019, her 13-year-old son, a leukemia patient at Loma Linda (Calif.) University Hospital, felt frightened. Ms. Valenta said she felt a “gut-wrenching feeling of just fear and anger.” They were finally able to get doses of the drug after launching a social media campaign.

Such drug shortages are especially widespread in oncology and hematology, according to a survey of oncology pharmacists at 68 organizations nationwide. Published in the May 2022 issue of Oncology Practice, the study showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

The pharmacists surveyed between May 2019 and July 2020 were asked about the three most hard-to-get chemotherapy and supportive care agents. Vincristine topped the list, followed by vinblastine, IVIG, leucovorin, and BCG, as well as difficult-to-obtain ropine, erwinia asparaginase, etoposide, and leuprolide. Several of these drugs are used to treat conditions such as lymphoma and leukemia.

Eighty-two percent of respondents reported shortages of decitabine (IV), often used as part of a cocktail with vinblastine and other drugs to treat Hodgkin lymphoma.

The reasons for drug shortages are varied. The CBS News report declared that “pharmaceutical companies have stopped producing many life-saving generic drugs because they make too little profit,” and it suggested that the federal government isn’t doing enough.

But government action actually might be making a difference. According to the FDA, the number of new drug shortages has fallen dramatically from 250 in 2011 to 41 in 2021, and the number of prevented drug shortages rose from nearly 200 to more than 300 over that same period. Still, the number of ongoing drug shortages has risen from around 40 in 2017 to about 80 in 2021.

Reasons for the paucity of certain drugs are often unclear. In a June 12, 2022 post, for example, the American Society of Health-System Pharmacists’ drug shortage database noted that the chemotherapy drug fludarabine was in short supply and provided details about when some of the 5 manufacturers expected to have it available. (This is the shortage that Dr. Greene was trying to manage.) But 4 of the 5 manufacturers “did not provide a reason,” and the fifth blamed manufacturing delays.

“There’s a lot of closely held trade secrets that hinder the ability to share good information,” said Dr. Greene. To make things more complicated, shipping times are often unreliable. “The product doesn’t show up today, we place another order. Sometimes it will show up tomorrow, sometimes it doesn’t,” he said. “If you’re not tracking it carefully, you deplete your own supply.”

Patients’ families have grown used to dealing with drug shortages, and “they’re less quick to blame personnel at our institution.”

How can hematologists cope with this issue? “The best thing in the immediate term is to advocate for their hospital to have a pharmacist dedicated to shortage monitoring and taking proactive steps to obviate shortages,” hematologist/oncologist Andrew Hantel, MD, an instructor at Dana-Farber Cancer Institute, Harvard Medical School, Boston, said in an interview.

“We have ongoing communications with other large cancer centers and the FDA to recognize shortages early and develop plans to make sure we stay ahead of them,” Dr. Hantel said. “Most often this involves assessing supply, use rates, alternative manufacturers, and additional measures the Food and Drug Administration can take (for example, importation), and occasionally working with clinical teams to see if other medications are feasible alternatives.”

If a drug is unavailable, it can also be helpful to discuss alternative approaches. “We did not have any frank shortages of vincristine,” Dr. Hantel said, “but we did focus on conservation measures and considered different ethically appropriate ways to distribute vincristine if there was a point at which we did not have enough for everyone who needed it.”

If a drug is in short supply, options can include delaying treatment, giving an alternative, or providing the rest of the regimen without the scarce drug, he said. In a 2021 report in The Lancet Hematology, Dr. Hantel and his colleagues offered “model solutions for ethical allocation during cancer medicine shortages.”

The authors of the May 2022 drug-shortage report highlighted an alternative regimen in hematology. They noted that manufacturing delays have limited the supply of dacarbazine, used for Hodgkin lymphoma. Due to the current shortages, they wrote, clinicians are considering the use of escalated bleomycin, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, replacing dacarbazine with procarbazine and using the doxorubicin, bleomycin, vinblastine, procarbazine, and prednisone regimen, or replacing dacarbazine with cyclophosphamide.

Dr. Greene emphasized the importance of tracking the news and the drug shortage websites run by the FDA and the American Society of Health-System Pharmacists.

It’s also crucial to have a good relationship with your wholesaler, he added, and to communicate about these problems within your facility. At his hospital, the pharmaceutical staff holds a multi-disciplinary meeting at least weekly to discuss the supply of medications. As he put it, “it’s a challenging environment.”

Dr. Greene and Dr. Hantel reported no relevant disclosures.

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Moderate drinking shows more benefit for older vs. younger adults

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Young adults aged 15-34 years derive no significant health benefits from alcohol consumption, but moderate drinking may benefit the over-40 crowd, according to a new analysis.

The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.

“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.

Dr. Noel Deep

“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.  

“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
 

Methods and results

In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.

One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.

Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.

For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.

The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).

The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.

However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.

“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
 

 

 

Consider individual factors when counseling patients

The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.

“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
 

Health and alcohol interaction is complicated

“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.

However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.

“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.

In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”

Data can guide clinical practice

No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.

“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.

This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.

As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.

The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.

The study was supported by the Bill and Melinda Gates Foundation.

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Young adults aged 15-34 years derive no significant health benefits from alcohol consumption, but moderate drinking may benefit the over-40 crowd, according to a new analysis.

The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.

“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.

Dr. Noel Deep

“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.  

“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
 

Methods and results

In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.

One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.

Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.

For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.

The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).

The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.

However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.

“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
 

 

 

Consider individual factors when counseling patients

The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.

“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
 

Health and alcohol interaction is complicated

“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.

However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.

“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.

In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”

Data can guide clinical practice

No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.

“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.

This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.

As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.

The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.

The study was supported by the Bill and Melinda Gates Foundation.

Young adults aged 15-34 years derive no significant health benefits from alcohol consumption, but moderate drinking may benefit the over-40 crowd, according to a new analysis.

The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.

“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.

Dr. Noel Deep

“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.  

“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
 

Methods and results

In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.

One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.

Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.

For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.

The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).

The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.

However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.

“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
 

 

 

Consider individual factors when counseling patients

The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.

“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
 

Health and alcohol interaction is complicated

“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.

However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.

“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.

In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”

Data can guide clinical practice

No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.

“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.

This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.

As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.

The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.

The study was supported by the Bill and Melinda Gates Foundation.

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Techniques and Innovations in Gastrointestinal Endoscopy

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