Practice Management

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

This article was originally published on February 10 in Eric Topol’s substack “Ground Truths.”

It’s astounding how devious cancer cells and tumor tissue can be. This week in Science we learned how certain lung cancer cells can function like “Catch Me If You Can” — changing their driver mutation and cell identity to escape targeted therapy. This histologic transformation, as seen in an experimental model, is just one of so many cancer tricks that we are learning about.

Recently, as shown by single-cell sequencing, cancer cells can steal the mitochondria from T cells, a double whammy that turbocharges cancer cells with the hijacked fuel supply and, at the same time, dismantles the immune response.

Last week, we saw how tumor cells can release a virus-like protein that unleashes a vicious autoimmune response.

And then there’s the finding that cancer cell spread predominantly is occurring while we sleep.

As I previously reviewed, the ability for cancer cells to hijack neurons and neural circuits is now well established, no less their ability to reprogram neurons to become adrenergic and stimulate tumor progression, and interfere with the immune response. Stay tuned on that for a new Ground Truths podcast with Prof Michelle Monje, a leader in cancer neuroscience, which will post soon.

Add advancing age’s immunosenescence as yet another challenge to the long and growing list of formidable ways that cancer cells, and the tumor microenvironment, evade our immune response.

An Ever-Expanding Armamentarium

All of this is telling us how we need to ramp up our game if we are going to be able to use our immune system to quash a cancer. Fortunately, we have abundant and ever-growing capabilities for doing just that.

Immune Checkpoint Inhibitors

The field of immunotherapies took off with the immune checkpoint inhibitors, first approved by the FDA in 2011, that take the brakes off of T cells, with the programmed death-1 (PD-1), PD-ligand1, and anti-CTLA-4 monoclonal antibodies.

But we’re clearly learning they are not enough to prevail over cancer with common recurrences, only short term success in most patients, with some notable exceptions. Adding other immune response strategies, such as a vaccine, or antibody-drug conjugates, or engineered T cells, are showing improved chances for success.

Therapeutic Cancer Vaccines

There are many therapeutic cancer vaccines in the works, as reviewed in depth here.

Here’s a list of ongoing clinical trials of cancer vaccines. You’ll note most of these are on top of a checkpoint inhibitor and use personalized neoantigens (cancer cell surface proteins) derived from sequencing (whole-exome or whole genome, RNA-sequencing and HLA-profiling) the patient’s tumor.

An example of positive findings is with the combination of an mRNA-nanoparticle vaccine with up to 34 personalized neoantigens and pembrolizumab (Keytruda) vs pembrolizumab alone in advanced melanoma after resection, with improved outcomes at 3-year follow-up, cutting death or relapse rate in half.

Antibody-Drug Conjugates (ADC)

There is considerable excitement about antibody-drug conjugates (ADC) whereby a linker is used to attach a chemotherapy agent to the checkpoint inhibitor antibody, specifically targeting the cancer cell and facilitating entry of the chemotherapy into the cell. Akin to these are bispecific antibodies (BiTEs, binding to a tumor antigen and T cell receptor simultaneously), both of these conjugates acting as “biologic” or “guided” missiles.

A very good example of the potency of an ADC was seen in a “HER2-low” breast cancer randomized trial. The absence or very low expression or amplification of the HER2 receptor is common in breast cancer and successful treatment has been elusive. A randomized trial of an ADC (trastuzumab deruxtecan) compared to physician’s choice therapy demonstrated a marked success for progression-free survival in HER2-low patients, which was characterized as “unheard-of success” by media coverage.

This strategy is being used to target some of the most difficult cancer driver mutations such as TP53 and KRAS.

Oncolytic Viruses

Modifying viruses to infect the tumor and make it more visible to the immune system, potentiating anti-tumor responses, known as oncolytic viruses, have been proposed as a way to rev up the immune response for a long time but without positive Phase 3 clinical trials.

After decades of failure, a recent trial in refractory bladder cancer showed marked success, along with others, summarized here, now providing very encouraging results. It looks like oncolytic viruses are on a comeback path.

Engineering T Cells (Chimeric Antigen Receptor [CAR-T])

As I recently reviewed, there are over 500 ongoing clinical trials to build on the success of the first CAR-T approval for leukemia 7 years ago. I won’t go through that all again here, but to reiterate most of the success to date has been in “liquid” blood (leukemia and lymphoma) cancer tumors. This week in Nature is the discovery of a T cell cancer mutation, a gene fusion CARD11-PIK3R3, from a T cell lymphoma that can potentially be used to augment CAR-T efficacy. It has pronounced and prolonged effects in the experimental model. Instead of 1 million cells needed for treatment, even 20,000 were enough to melt the tumor. This is a noteworthy discovery since CAR-T work to date has largely not exploited such naturally occurring mutations, while instead concentrating on those seen in the patient’s set of key tumor mutations.

As currently conceived, CAR-T, and what is being referred to more broadly as adoptive cell therapies, involves removing T cells from the patient’s body and engineering their activation, then reintroducing them back to the patient. This is laborious, technically difficult, and very expensive. Recently, the idea of achieving all of this via an injection of virus that specifically infects T cells and inserts the genes needed, was advanced by two biotech companies with preclinical results, one in non-human primates.

Gearing up to meet the challenge of solid tumor CAR-T intervention, there’s more work using CRISPR genome editing of T cell receptors. A.I. is increasingly being exploited to process the data from sequencing and identify optimal neoantigens.

Instead of just CAR-T, we’re seeing the emergence of CAR-macrophage and CAR-natural killer (NK) cells strategies, and rapidly expanding potential combinations of all the strategies I’ve mentioned. No less, there’s been maturation of on-off suicide switches programmed in, to limit cytokine release and promote safety of these interventions. Overall, major side effects of immunotherapies are not only cytokine release syndromes, but also include interstitial pneumonitis and neurotoxicity.

Summary

Given the multitude of ways cancer cells and tumor tissue can evade our immune response, durably successful treatment remains a daunting challenge. But the ingenuity of so many different approaches to unleash our immune response, and their combinations, provides considerable hope that we’ll increasingly meet the challenge in the years ahead. We have clearly learned that combining different immunotherapy strategies will be essential for many patients with the most resilient solid tumors.

Of concern, as noted by a recent editorial in The Lancet, entitled “Cancer Research Equity: Innovations For The Many, Not The Few,” is that these individualized, sophisticated strategies are not scalable; they will have limited reach and benefit. The movement towards “off the shelf” CAR-T and inexpensive, orally active checkpoint inhibitors may help mitigate this issue.

Notwithstanding this important concern, we’re seeing an array of diverse and potent immunotherapy strategies that are providing highly encouraging results, engendering more excitement than we’ve seen in this space for some time. These should propel substantial improvements in outcomes for patients in the years ahead. It can’t happen soon enough.

Thanks for reading this edition of Ground Truths. If you found it informative, please share it with your colleagues.

Dr. Topol has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Dexcom; Illumina; Molecular Stethoscope; Quest Diagnostics; Blue Cross Blue Shield Association. Received research grant from National Institutes of Health.

A version of this article appeared on Medscape.com.

This article was originally published on February 10 in Eric Topol’s substack “Ground Truths.”

It’s astounding how devious cancer cells and tumor tissue can be. This week in Science we learned how certain lung cancer cells can function like “Catch Me If You Can” — changing their driver mutation and cell identity to escape targeted therapy. This histologic transformation, as seen in an experimental model, is just one of so many cancer tricks that we are learning about.

Recently, as shown by single-cell sequencing, cancer cells can steal the mitochondria from T cells, a double whammy that turbocharges cancer cells with the hijacked fuel supply and, at the same time, dismantles the immune response.

Last week, we saw how tumor cells can release a virus-like protein that unleashes a vicious autoimmune response.

And then there’s the finding that cancer cell spread predominantly is occurring while we sleep.

As I previously reviewed, the ability for cancer cells to hijack neurons and neural circuits is now well established, no less their ability to reprogram neurons to become adrenergic and stimulate tumor progression, and interfere with the immune response. Stay tuned on that for a new Ground Truths podcast with Prof Michelle Monje, a leader in cancer neuroscience, which will post soon.

Add advancing age’s immunosenescence as yet another challenge to the long and growing list of formidable ways that cancer cells, and the tumor microenvironment, evade our immune response.

An Ever-Expanding Armamentarium

All of this is telling us how we need to ramp up our game if we are going to be able to use our immune system to quash a cancer. Fortunately, we have abundant and ever-growing capabilities for doing just that.

Immune Checkpoint Inhibitors

The field of immunotherapies took off with the immune checkpoint inhibitors, first approved by the FDA in 2011, that take the brakes off of T cells, with the programmed death-1 (PD-1), PD-ligand1, and anti-CTLA-4 monoclonal antibodies.

But we’re clearly learning they are not enough to prevail over cancer with common recurrences, only short term success in most patients, with some notable exceptions. Adding other immune response strategies, such as a vaccine, or antibody-drug conjugates, or engineered T cells, are showing improved chances for success.

Therapeutic Cancer Vaccines

There are many therapeutic cancer vaccines in the works, as reviewed in depth here.

Here’s a list of ongoing clinical trials of cancer vaccines. You’ll note most of these are on top of a checkpoint inhibitor and use personalized neoantigens (cancer cell surface proteins) derived from sequencing (whole-exome or whole genome, RNA-sequencing and HLA-profiling) the patient’s tumor.

An example of positive findings is with the combination of an mRNA-nanoparticle vaccine with up to 34 personalized neoantigens and pembrolizumab (Keytruda) vs pembrolizumab alone in advanced melanoma after resection, with improved outcomes at 3-year follow-up, cutting death or relapse rate in half.

Antibody-Drug Conjugates (ADC)

There is considerable excitement about antibody-drug conjugates (ADC) whereby a linker is used to attach a chemotherapy agent to the checkpoint inhibitor antibody, specifically targeting the cancer cell and facilitating entry of the chemotherapy into the cell. Akin to these are bispecific antibodies (BiTEs, binding to a tumor antigen and T cell receptor simultaneously), both of these conjugates acting as “biologic” or “guided” missiles.

A very good example of the potency of an ADC was seen in a “HER2-low” breast cancer randomized trial. The absence or very low expression or amplification of the HER2 receptor is common in breast cancer and successful treatment has been elusive. A randomized trial of an ADC (trastuzumab deruxtecan) compared to physician’s choice therapy demonstrated a marked success for progression-free survival in HER2-low patients, which was characterized as “unheard-of success” by media coverage.

This strategy is being used to target some of the most difficult cancer driver mutations such as TP53 and KRAS.

Oncolytic Viruses

Modifying viruses to infect the tumor and make it more visible to the immune system, potentiating anti-tumor responses, known as oncolytic viruses, have been proposed as a way to rev up the immune response for a long time but without positive Phase 3 clinical trials.

After decades of failure, a recent trial in refractory bladder cancer showed marked success, along with others, summarized here, now providing very encouraging results. It looks like oncolytic viruses are on a comeback path.

Engineering T Cells (Chimeric Antigen Receptor [CAR-T])

As I recently reviewed, there are over 500 ongoing clinical trials to build on the success of the first CAR-T approval for leukemia 7 years ago. I won’t go through that all again here, but to reiterate most of the success to date has been in “liquid” blood (leukemia and lymphoma) cancer tumors. This week in Nature is the discovery of a T cell cancer mutation, a gene fusion CARD11-PIK3R3, from a T cell lymphoma that can potentially be used to augment CAR-T efficacy. It has pronounced and prolonged effects in the experimental model. Instead of 1 million cells needed for treatment, even 20,000 were enough to melt the tumor. This is a noteworthy discovery since CAR-T work to date has largely not exploited such naturally occurring mutations, while instead concentrating on those seen in the patient’s set of key tumor mutations.

As currently conceived, CAR-T, and what is being referred to more broadly as adoptive cell therapies, involves removing T cells from the patient’s body and engineering their activation, then reintroducing them back to the patient. This is laborious, technically difficult, and very expensive. Recently, the idea of achieving all of this via an injection of virus that specifically infects T cells and inserts the genes needed, was advanced by two biotech companies with preclinical results, one in non-human primates.

Gearing up to meet the challenge of solid tumor CAR-T intervention, there’s more work using CRISPR genome editing of T cell receptors. A.I. is increasingly being exploited to process the data from sequencing and identify optimal neoantigens.

Instead of just CAR-T, we’re seeing the emergence of CAR-macrophage and CAR-natural killer (NK) cells strategies, and rapidly expanding potential combinations of all the strategies I’ve mentioned. No less, there’s been maturation of on-off suicide switches programmed in, to limit cytokine release and promote safety of these interventions. Overall, major side effects of immunotherapies are not only cytokine release syndromes, but also include interstitial pneumonitis and neurotoxicity.

Summary

Given the multitude of ways cancer cells and tumor tissue can evade our immune response, durably successful treatment remains a daunting challenge. But the ingenuity of so many different approaches to unleash our immune response, and their combinations, provides considerable hope that we’ll increasingly meet the challenge in the years ahead. We have clearly learned that combining different immunotherapy strategies will be essential for many patients with the most resilient solid tumors.

Of concern, as noted by a recent editorial in The Lancet, entitled “Cancer Research Equity: Innovations For The Many, Not The Few,” is that these individualized, sophisticated strategies are not scalable; they will have limited reach and benefit. The movement towards “off the shelf” CAR-T and inexpensive, orally active checkpoint inhibitors may help mitigate this issue.

Notwithstanding this important concern, we’re seeing an array of diverse and potent immunotherapy strategies that are providing highly encouraging results, engendering more excitement than we’ve seen in this space for some time. These should propel substantial improvements in outcomes for patients in the years ahead. It can’t happen soon enough.

Thanks for reading this edition of Ground Truths. If you found it informative, please share it with your colleagues.

Dr. Topol has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Dexcom; Illumina; Molecular Stethoscope; Quest Diagnostics; Blue Cross Blue Shield Association. Received research grant from National Institutes of Health.

A version of this article appeared on Medscape.com.

This article was originally published on February 10 in Eric Topol’s substack “Ground Truths.”

It’s astounding how devious cancer cells and tumor tissue can be. This week in Science we learned how certain lung cancer cells can function like “Catch Me If You Can” — changing their driver mutation and cell identity to escape targeted therapy. This histologic transformation, as seen in an experimental model, is just one of so many cancer tricks that we are learning about.

Recently, as shown by single-cell sequencing, cancer cells can steal the mitochondria from T cells, a double whammy that turbocharges cancer cells with the hijacked fuel supply and, at the same time, dismantles the immune response.

Last week, we saw how tumor cells can release a virus-like protein that unleashes a vicious autoimmune response.

And then there’s the finding that cancer cell spread predominantly is occurring while we sleep.

As I previously reviewed, the ability for cancer cells to hijack neurons and neural circuits is now well established, no less their ability to reprogram neurons to become adrenergic and stimulate tumor progression, and interfere with the immune response. Stay tuned on that for a new Ground Truths podcast with Prof Michelle Monje, a leader in cancer neuroscience, which will post soon.

Add advancing age’s immunosenescence as yet another challenge to the long and growing list of formidable ways that cancer cells, and the tumor microenvironment, evade our immune response.

An Ever-Expanding Armamentarium

All of this is telling us how we need to ramp up our game if we are going to be able to use our immune system to quash a cancer. Fortunately, we have abundant and ever-growing capabilities for doing just that.

Immune Checkpoint Inhibitors

The field of immunotherapies took off with the immune checkpoint inhibitors, first approved by the FDA in 2011, that take the brakes off of T cells, with the programmed death-1 (PD-1), PD-ligand1, and anti-CTLA-4 monoclonal antibodies.

But we’re clearly learning they are not enough to prevail over cancer with common recurrences, only short term success in most patients, with some notable exceptions. Adding other immune response strategies, such as a vaccine, or antibody-drug conjugates, or engineered T cells, are showing improved chances for success.

Therapeutic Cancer Vaccines

There are many therapeutic cancer vaccines in the works, as reviewed in depth here.

Here’s a list of ongoing clinical trials of cancer vaccines. You’ll note most of these are on top of a checkpoint inhibitor and use personalized neoantigens (cancer cell surface proteins) derived from sequencing (whole-exome or whole genome, RNA-sequencing and HLA-profiling) the patient’s tumor.

An example of positive findings is with the combination of an mRNA-nanoparticle vaccine with up to 34 personalized neoantigens and pembrolizumab (Keytruda) vs pembrolizumab alone in advanced melanoma after resection, with improved outcomes at 3-year follow-up, cutting death or relapse rate in half.

Antibody-Drug Conjugates (ADC)

There is considerable excitement about antibody-drug conjugates (ADC) whereby a linker is used to attach a chemotherapy agent to the checkpoint inhibitor antibody, specifically targeting the cancer cell and facilitating entry of the chemotherapy into the cell. Akin to these are bispecific antibodies (BiTEs, binding to a tumor antigen and T cell receptor simultaneously), both of these conjugates acting as “biologic” or “guided” missiles.

A very good example of the potency of an ADC was seen in a “HER2-low” breast cancer randomized trial. The absence or very low expression or amplification of the HER2 receptor is common in breast cancer and successful treatment has been elusive. A randomized trial of an ADC (trastuzumab deruxtecan) compared to physician’s choice therapy demonstrated a marked success for progression-free survival in HER2-low patients, which was characterized as “unheard-of success” by media coverage.

This strategy is being used to target some of the most difficult cancer driver mutations such as TP53 and KRAS.

Oncolytic Viruses

Modifying viruses to infect the tumor and make it more visible to the immune system, potentiating anti-tumor responses, known as oncolytic viruses, have been proposed as a way to rev up the immune response for a long time but without positive Phase 3 clinical trials.

After decades of failure, a recent trial in refractory bladder cancer showed marked success, along with others, summarized here, now providing very encouraging results. It looks like oncolytic viruses are on a comeback path.

Engineering T Cells (Chimeric Antigen Receptor [CAR-T])

As I recently reviewed, there are over 500 ongoing clinical trials to build on the success of the first CAR-T approval for leukemia 7 years ago. I won’t go through that all again here, but to reiterate most of the success to date has been in “liquid” blood (leukemia and lymphoma) cancer tumors. This week in Nature is the discovery of a T cell cancer mutation, a gene fusion CARD11-PIK3R3, from a T cell lymphoma that can potentially be used to augment CAR-T efficacy. It has pronounced and prolonged effects in the experimental model. Instead of 1 million cells needed for treatment, even 20,000 were enough to melt the tumor. This is a noteworthy discovery since CAR-T work to date has largely not exploited such naturally occurring mutations, while instead concentrating on those seen in the patient’s set of key tumor mutations.

As currently conceived, CAR-T, and what is being referred to more broadly as adoptive cell therapies, involves removing T cells from the patient’s body and engineering their activation, then reintroducing them back to the patient. This is laborious, technically difficult, and very expensive. Recently, the idea of achieving all of this via an injection of virus that specifically infects T cells and inserts the genes needed, was advanced by two biotech companies with preclinical results, one in non-human primates.

Gearing up to meet the challenge of solid tumor CAR-T intervention, there’s more work using CRISPR genome editing of T cell receptors. A.I. is increasingly being exploited to process the data from sequencing and identify optimal neoantigens.

Instead of just CAR-T, we’re seeing the emergence of CAR-macrophage and CAR-natural killer (NK) cells strategies, and rapidly expanding potential combinations of all the strategies I’ve mentioned. No less, there’s been maturation of on-off suicide switches programmed in, to limit cytokine release and promote safety of these interventions. Overall, major side effects of immunotherapies are not only cytokine release syndromes, but also include interstitial pneumonitis and neurotoxicity.

Summary

Given the multitude of ways cancer cells and tumor tissue can evade our immune response, durably successful treatment remains a daunting challenge. But the ingenuity of so many different approaches to unleash our immune response, and their combinations, provides considerable hope that we’ll increasingly meet the challenge in the years ahead. We have clearly learned that combining different immunotherapy strategies will be essential for many patients with the most resilient solid tumors.

Of concern, as noted by a recent editorial in The Lancet, entitled “Cancer Research Equity: Innovations For The Many, Not The Few,” is that these individualized, sophisticated strategies are not scalable; they will have limited reach and benefit. The movement towards “off the shelf” CAR-T and inexpensive, orally active checkpoint inhibitors may help mitigate this issue.

Notwithstanding this important concern, we’re seeing an array of diverse and potent immunotherapy strategies that are providing highly encouraging results, engendering more excitement than we’ve seen in this space for some time. These should propel substantial improvements in outcomes for patients in the years ahead. It can’t happen soon enough.

Thanks for reading this edition of Ground Truths. If you found it informative, please share it with your colleagues.

Dr. Topol has disclosed the following relevant financial relationships: Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for Dexcom; Illumina; Molecular Stethoscope; Quest Diagnostics; Blue Cross Blue Shield Association. Received research grant from National Institutes of Health.

A version of this article appeared on Medscape.com.

Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

Your patients come in wanting a script for the latest medication they saw on a television commercial (Ozempic anyone?), a request for a medical marijuana card for their shoulder ache, or any number of pleas for drugs, procedures, or tests that are medically inappropriate.

One of the toughest parts of the job as a physician is balancing patient requests with patient satisfaction. In the age of Healthgrades, Yelp reviews, and patients sharing their visit high points on multiple social media platforms, how can you keep patients happy and satisfied when you have to say no?

Turns out, you can likely reroute those patient-driven requests if you can get to the heart of the issue the patient is looking to resolve, suggested Peter Lee, MD, a plastic surgeon at Wave Plastic Surgery in Los Angeles.

“The conversation between physicians and patients hinges less on the answer ‘no’ than it does on being a careful listener,” he said. “This includes focusing on the different available treatment options and then deciding which of these is most suitable to the particular situation facing that patient.”

Here are a few failsafe ways to say no — and why physicians think these approaches can make the difference between a contentious appointment and a positive one.
 

Hear Patients Out

When patients book an appointment with a physician to discuss a noncritical issue, they likely have a sense from Google of what they might need, which is why Dara Kass, MD, an emergency medicine physician in Hartford, Connecticut, always asks patients “why did you come in” and “what test do you think you need.”

“For example, they may say, ‘I came for a CT scan of my head because I’ve had a headache for 2 years, and it’s frustrating trying to find a neurologist,’” she said. “Maybe they don’t need a CT scan after all, but it’s up to me to figure that out, and letting them share what they think they need frames out a feeling that we’re making joint decisions.”
 

Help Patients Rethink Requests

The ubiquity of online searching is just one reason patients may tend to arrive at your office armed with “information.” This is especially true for patients seeking plastic surgery, said Dr. Lee. “A plastic surgeon’s reaction to such a request may be less about saying ‘no’ than taking the patient a few steps back in the decision-making process,” he said. “The goal should be to educate the patient, in the case of plastic surgery, about what is actually causing the appearance he or she is trying to correct.”

For something like a marijuana card for a slight ache, explaining that it may not be appropriate and “here’s what we can do instead” goes a long way in getting the patient to rethink and understand that their request may not be legitimate.
 

Use Safety Concerns as an Out

Often, a patient just isn’t a good candidate for a procedure, said Samuel Lin, MD, a plastic surgeon in Boston and an associate professor of surgery at Harvard Medical School, Boston. “They may think they need to have a procedure, but it might not be a safe thing for them to have it,” he said.

“I would lean heavily on the fact that it may not be medically safe for this patient to have this procedure due to elements of their medical history or the fact that they have had prior surgeries. Then, if you pivot to the more conservative things you can do, this can help you say no when a patient is seeking a certain procedure.”

Likewise, explaining that a weight loss drug may have more risks than benefits and isn’t appropriate for that 15 pounds they’re struggling with couched as a safety concern can ease the disappointment of a no.
 

Remind Patients That Tests Can Be Costly

It’s one thing for a patient to request certain tests, say an MRI or a CT scan, but those same patients may grumble when they get the bill for the tests. That said, it’s always a good idea to remind them of the costs of these tests, said Dr. Kass. Patients will get bills in the mail after their visit for those extra tests and scans. “They may not realize this until after they asked for it, and if they, for example, have $1000 in coinsurance, that bill may be a very upsetting surprise.”
 

You Can’t Always Prevent a Negative Patient Review

No matter how hard you try, a patient may still be unhappy that you’ve declined their request, and this may show up in the form of a negative review for all to see. However, it’s always best to keep these reviews in perspective. “The ‘no’ that might result in a bad review can happen for everything from waiting 15 minutes to see the doctor to not getting a discount at checkout and everything in between including being told they don’t need the drug, test, or procedure they requested.”

“I feel like people who write bad reviews want money back, or they have an alternative agenda. That’s why, I educate patients and empower them to make the right decisions,” said Jody A. Levine, MD, director of dermatology at Plastic Surgery & Dermatology of New York City.

Dr. Lee told this news organization that the fundamental pledge to “do no harm” is as good as any other credo when saying no to patients. “If we don’t believe there is a likely probability that a surgery will be safe to perform on a patient and leave the patient satisfied with the result, then it is our duty to decline to perform that surgery.”

Ultimately, being transparent leads to a happy doctor-patient relationship. “As long as you are clear and honest in explaining to a patient why you are declining to perform a procedure, most patients, rather than being angry with you, will thank you for your candor,” he said. “They’ll leave your office a little bit wiser, too.”

A version of this article appeared on Medscape.com.

TOPLINE:

ChatGPT (version 3.5) provides relatively poor and inconsistent responses when asked about appropriate colorectal cancer (CRC) screening and surveillance, a new study showed.

METHODOLOGY:

• Three board-certified gastroenterologists with 10+ years of clinical experience developed five CRC screening and five CRC surveillance clinical vignettes (with multiple choice answers), which were fed to ChatGPT version 3.5.
• ChatGPT’s responses were recorded over four separate sessions and screened for accuracy to determine reliability of the tool.
• The average number of correct answers was compared to that of 238 gastroenterologists and colorectal surgeons answering the same questions with and without the help of a previously validated CRC screening mobile app.

TAKEAWAY:

• ChatGPT’s average overall performance was 45%; the average number of correct answers was 2.75 for screening and 1.75 for surveillance.
• ChatGPT’s responses were inconsistent in a large proportion of questions; the tool gave a different answer in four questions among the different sessions.
• The average number of total correct answers of ChatGPT was significantly lower (P < .001) than that of physicians with and without the mobile app (7.71 and 5.62 correct answers, respectively).

IN PRACTICE:

“The use of validated mobile apps with decision-making algorithms could serve as more reliable assistants until large language models developed with AI are further refined,” the authors concluded.

SOURCE:

The study, with first author Lisandro Pereyra, MD, Department of Gastroenterology, Hospital Alemán of Buenos Aires, Argentina, was published online on February 7, 2024, in the Journal of Clinical Gastroenterology.

LIMITATIONS:

The 10 clinical vignettes represented a relatively small sample size to assess accuracy. The study did not use the latest version of ChatGPT. No “fine-tuning” attempts with inputs of diverse prompts, instructions, or relevant data were performed, which could potentially improve the performance of the chatbot.

DISCLOSURES:

The study had no specific funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

ChatGPT (version 3.5) provides relatively poor and inconsistent responses when asked about appropriate colorectal cancer (CRC) screening and surveillance, a new study showed.

METHODOLOGY:

• Three board-certified gastroenterologists with 10+ years of clinical experience developed five CRC screening and five CRC surveillance clinical vignettes (with multiple choice answers), which were fed to ChatGPT version 3.5.
• ChatGPT’s responses were recorded over four separate sessions and screened for accuracy to determine reliability of the tool.
• The average number of correct answers was compared to that of 238 gastroenterologists and colorectal surgeons answering the same questions with and without the help of a previously validated CRC screening mobile app.

TAKEAWAY:

• ChatGPT’s average overall performance was 45%; the average number of correct answers was 2.75 for screening and 1.75 for surveillance.
• ChatGPT’s responses were inconsistent in a large proportion of questions; the tool gave a different answer in four questions among the different sessions.
• The average number of total correct answers of ChatGPT was significantly lower (P < .001) than that of physicians with and without the mobile app (7.71 and 5.62 correct answers, respectively).

IN PRACTICE:

“The use of validated mobile apps with decision-making algorithms could serve as more reliable assistants until large language models developed with AI are further refined,” the authors concluded.

SOURCE:

The study, with first author Lisandro Pereyra, MD, Department of Gastroenterology, Hospital Alemán of Buenos Aires, Argentina, was published online on February 7, 2024, in the Journal of Clinical Gastroenterology.

LIMITATIONS:

The 10 clinical vignettes represented a relatively small sample size to assess accuracy. The study did not use the latest version of ChatGPT. No “fine-tuning” attempts with inputs of diverse prompts, instructions, or relevant data were performed, which could potentially improve the performance of the chatbot.

DISCLOSURES:

The study had no specific funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

ChatGPT (version 3.5) provides relatively poor and inconsistent responses when asked about appropriate colorectal cancer (CRC) screening and surveillance, a new study showed.

METHODOLOGY:

• Three board-certified gastroenterologists with 10+ years of clinical experience developed five CRC screening and five CRC surveillance clinical vignettes (with multiple choice answers), which were fed to ChatGPT version 3.5.
• ChatGPT’s responses were recorded over four separate sessions and screened for accuracy to determine reliability of the tool.
• The average number of correct answers was compared to that of 238 gastroenterologists and colorectal surgeons answering the same questions with and without the help of a previously validated CRC screening mobile app.

TAKEAWAY:

• ChatGPT’s average overall performance was 45%; the average number of correct answers was 2.75 for screening and 1.75 for surveillance.
• ChatGPT’s responses were inconsistent in a large proportion of questions; the tool gave a different answer in four questions among the different sessions.
• The average number of total correct answers of ChatGPT was significantly lower (P < .001) than that of physicians with and without the mobile app (7.71 and 5.62 correct answers, respectively).

IN PRACTICE:

“The use of validated mobile apps with decision-making algorithms could serve as more reliable assistants until large language models developed with AI are further refined,” the authors concluded.

SOURCE:

The study, with first author Lisandro Pereyra, MD, Department of Gastroenterology, Hospital Alemán of Buenos Aires, Argentina, was published online on February 7, 2024, in the Journal of Clinical Gastroenterology.

LIMITATIONS:

The 10 clinical vignettes represented a relatively small sample size to assess accuracy. The study did not use the latest version of ChatGPT. No “fine-tuning” attempts with inputs of diverse prompts, instructions, or relevant data were performed, which could potentially improve the performance of the chatbot.

DISCLOSURES:

The study had no specific funding. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

A Pennsylvania urologist is suing his former employer for the alleged illegal enforcement of a noncompete agreement that limits his ability to practice locally for the next 2 years. 

The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice. 

According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania. 

Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure. 

Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN. 

Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation. 

After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said. 

Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said. 

Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs. 

For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1. 

“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland. 

Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said. 

Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”

That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses. 

Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants. 

Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.” 

As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord. 
 

A version of this article appeared on Medscape.com .

A Pennsylvania urologist is suing his former employer for the alleged illegal enforcement of a noncompete agreement that limits his ability to practice locally for the next 2 years. 

The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice. 

According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania. 

Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure. 

Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN. 

Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation. 

After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said. 

Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said. 

Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs. 

For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1. 

“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland. 

Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said. 

Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”

That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses. 

Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants. 

Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.” 

As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord. 
 

A version of this article appeared on Medscape.com .

A Pennsylvania urologist is suing his former employer for the alleged illegal enforcement of a noncompete agreement that limits his ability to practice locally for the next 2 years. 

The lawsuit brings renewed attention to the ongoing public discourse around restrictive covenants for physicians as more state and federal legislators signal plans to limit or ban the practice. 

According to a civil suit filed on January 30 in the Court of Common Pleas, Scranton, Pennsylvania, Eric Rottenberg, MD, signed a 3-year employment agreement with Commonwealth Health Physician Network (CPN) in November 2022. He worked for the health system from May to November 2023, seeing patients at several of its locations, including Wilkes-Barre General Hospital and other facilities throughout northeast and central Pennsylvania. 

Although Dr. Rottenberg previously practiced in Albany, New York, court records state he did not bring a significant referral or patient base to the new role, receive any specialized training, or have knowledge of CPN’s trade secrets during his tenure. 

Instead, he was a “9-to-5 practitioner,” or a physician-employee like a “locum tenens whose replacement would not cost the employer more than his traditional compensation,” the complaint said. Dr. Rottenberg only treated patients assigned to him by CPN and its parent company, Commonwealth Health Systems, and did not take a patient base with him upon his departure from CPN. 

Commonwealth Health spokesperson Annmarie Poslock declined to comment on pending litigation. 

After becoming frustrated by “restrictions on his ability to practice medicine” at CPN, Dr. Rottenberg submitted the required 90-day written notice to terminate the employment agreement. He subsequently received a letter from Simon Ratliff, CPN’s chief executive officer, confirming that his last day of employment would be February 11, 2024. Ratliff also reiterated that the noncompete clause would be enforced, essentially banning Dr. Rottenberg from practicing within a 20-mile radius of his previous CPN locations for the next 2 years, court documents said. 

Dr. Rottenberg was recruited by Lehigh Valley Physician Group (LVPG), part of Lehigh Valley Health Network, in December 2023 for a urology position at its Dickson City and Scranton locations — some of which are within 20 miles of CPN facilities, the complaint said. 

Employers often include noncompete terms in physician contracts because they want to keep the departing physician’s patients from following them to a competitor. However, about a dozen states and the District of Columbia have passed legislation that allows physicians and other clinicians to more easily exit contracts and change jobs. 

For example, an Indiana law took effect on July 1 that prohibits employers from entering a noncompete agreement with primary care physicians. Minnesota legislators also banned new noncompete agreements for all employees effective July 1. 

“There’s actually been a long-standing push for bans on physician noncompetes going back to some of the first states to pass them, like Colorado, Delaware, and Massachusetts, in the late 1970s and early 1980s,” said Evan Starr, PhD, associate professor of management and organization at the Robert H. Smith School of Business at the University of Maryland. 

Although New York Governor Kathy Hochul recently vetoed a bill that would have outlawed restrictive covenants, more states may consider passing laws that limit or ban noncompetes amid increasing patient equity and care access concerns. Dr. Starr told this news organization that one reason to eliminate restrictive covenants is because they can cause “third-party harm” to patients. “The patient doesn’t get the choice to sign a noncompete, but they’re going to be impacted by that agreement if the physician has to leave the area,” he said. 

Interestingly, one profession — lawyers — is the only occupation in the US for which noncompete agreements are banned, says Dr. Starr. “Basically, the American Medical Association (AMA) and other physician governing bodies haven’t made the same policies to exempt themselves that the lawyers have.”

That may be changing. In June, the AMA’s House of Delegates adopted policies to support the prohibition of noncompete contracts for employed physicians. The change came several months after the Federal Trade Commission (FTC) proposed a new rule that could more broadly ban companies from enforcing noncompete clauses. 

Despite Rottenberg’s attorney, Ryan Campbell, Esq, claiming that the noncompete is unenforceable without a protectable business interest, CPN would not release him from the agreement and opted to move forward with litigation, court records said. The suit cites several other cases where Pennsylvania judges have released physicians from similar restrictive covenants. 

Mr. Campbell told this news organization that he and his client are “working diligently with CPN and its counsel to resolve the matter amicably and without further litigation.” 

As employers await the FTC’s final rule, Dr. Starr says they could take steps to eliminate noncompete agreements altogether in favor of other stipulations. Contract terms prohibiting physicians from soliciting former patients could protect business interests and still allow patients to seek their preferred physician on their own accord. 
 

A version of this article appeared on Medscape.com .

A Nepali medical graduate has filed a federal lawsuit against the National Board of Medical Examiners (NBME), which invalidated her test results earlier this year in response to a widespread cheating scandal. 

Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act. 

Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action. 

The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal. 

The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.

A spokesman for the NBME said the board does not comment on pending litigation. 

Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit. 

“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
 

Doctor Says She Didn’t Cheat

Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam. 

A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.

Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years. 

If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit. 

“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
 

Lawsuit: Board Did Not Follow Published Practices

Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid. 

Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint. 

About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit. 

Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted. 

“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”

Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents. 

Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.

A version of this article appeared on Medscape.com.

A Nepali medical graduate has filed a federal lawsuit against the National Board of Medical Examiners (NBME), which invalidated her test results earlier this year in response to a widespread cheating scandal. 

Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act. 

Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action. 

The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal. 

The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.

A spokesman for the NBME said the board does not comment on pending litigation. 

Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit. 

“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
 

Doctor Says She Didn’t Cheat

Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam. 

A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.

Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years. 

If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit. 

“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
 

Lawsuit: Board Did Not Follow Published Practices

Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid. 

Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint. 

About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit. 

Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted. 

“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”

Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents. 

Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.

A version of this article appeared on Medscape.com.

A Nepali medical graduate has filed a federal lawsuit against the National Board of Medical Examiners (NBME), which invalidated her test results earlier this year in response to a widespread cheating scandal. 

Latika Giri, MBBS, of Kathmandu, claims the board violated its own procedures by invalidating exam scores before giving examinees a chance to argue and appeal, according to documents filed on February 12 in the US District Court for the District of Columbia. Dr. Giri alleges that the NBME’s actions were discriminatory against Nepali doctors and run afoul of the Civil Rights Act. 

Dr. Giri is requesting that the court block NBME from invalidating her scores while the lawsuit continues and restore her original results. The complaint was filed as a class action suit on behalf of Dr. Giri and other as yet unnamed plaintiffs affected by the board’s action. 

The lawsuit stems from a January 31 statement from the United States Medical Licensing Examination (USMLE) program that it was voiding scores attained by some examinees after an investigation revealed a pattern of anomalous exam performance associated with test-takers from Nepal. 

The announcement came just before the report about the selling and buying of USMLE questions online, and concerns that cheating on the exam had become “rampant” in recent years. The article was cited in Dr. Giri’s lawsuit.

A spokesman for the NBME said the board does not comment on pending litigation. 

Kritika Tara Deb, a Washington, DC–based attorney representing Dr. Giri, declined to answer specific questions about the case but expressed confidence in the outcome of the suit. 

“A policy that explicitly denies employment to an entire nationality or ethnicity is counter to US law and the USMLE’s non-discrimination principles,” Deb told this news organization in an email. “Such a blatantly discriminatory policy severely punishes honest doctors while unfairly maligning an entire nationality, and we’re confident it will not stand.”
 

Doctor Says She Didn’t Cheat

Dr. Giri is one of 22,000 foreign medical school graduates who complete the USMLE each year, in addition to the 24,000 US medical school graduates who take the exam. 

A 2022 graduate of the Kathmandu University School of Medical Sciences, Dr. Giri completed her board exams in 2023. According to her lawsuit, she studied hard and did not cheat, passing Step 1 and scoring a 252 on Step 2 and a 229 on Step 3. Dr. Giri took Step 1 in Nepal, Step 2 in India, and Step 3 in Connecticut, according to court documents. In January 2024, Dr. Giri was preparing to enter the residency match pool and hoping to start her training in the summer when she received an email from NBME saying her USMLE scores had been invalidated. She was accused of “extremely improbable answer similarity with other examinees testing on the same form at similar times, unusually high performance, and abnormal question response times,” according to the complaint.

Dr. Giri and other examinees affected by the invalidations were given until February 16 to choose from three options. They could request that NBME reconsider its decision, which could take up to 10 weeks; agree to retake the test; or do nothing, in which case their scores would remain invalid and their access to USMLE would be suspended for 3 years. 

If examinees chose options 1 or 2, they would be required to waive their right to sue NBME, according to Dr. Giri’s lawsuit. 

“Because of the schedule of medical-residency matching, all three options result in graduates being unable to practice medicine for at least a year,” attorneys for Dr. Giri wrote in the complaint. “All three options force many people to abruptly leave the country within 30 days and cause every affected person to lose their jobs or the opportunity to seek a job.”
 

Lawsuit: Board Did Not Follow Published Practices

Dr. Giri contends that NBME’s handling of the suspected cheating violates its own published procedures and treats the subset of Nepali examinees differently from other medical graduates. Examinees suspected of cheating are typically first advised of the matter, given an opportunity to share relevant information, and provided the right to appeal, according to the suit. During the process, the test-taker’s score is treated as valid. 

Dr. Giri and others were not provided this same treatment and had their scores invalidated on “the explicit basis that they were associated with Nepal,” the suit claims. The actions are in direct violation of the Civil Rights Act of 1964, which forbids discrimination against “any individual with respect to his terms, conditions, or privileges of employment, because of such individual’s race, color, religion, sex, or national origin,” according to the complaint. 

About 800 people are in the subset of Nepali test-takers targeted by the NBME, according to the suit. 

Dr. Giri said the score invalidations will cause plaintiffs “irreparable harm” if the NBME’s actions are not promptly halted. 

“As of January 31, 2024, plaintiffs who are applying to medical residencies are all ineligible for the Match, the deadline for which is February 28, 2024,” attorneys for Dr. Giri wrote. “All plaintiffs will thus miss this year’s Match no matter what. And NBME has offered no explanation for why it waited until the day before the Match opened to abruptly suspended plaintiffs’ scores: Dr. Giri and many others took some of the invalidated exams more than a year ago.”

Dr. Giri is requesting a decision by the court by February 21. The NBME meanwhile, plans to issue a legal response by February 19, according to court documents. 

Meanwhile, a petition started on change.org by a US emergency physician born calls for the USMLE program to degeneralize the wording of its January 31 statement. The USMLE statement “casts a shadow over the achievement of a supermajority of physicians from Nepal who succeeded through perseverance, honesty, and intelligence,” according to the petition. Petitioners want the USMLE program to change and clarify that it does “not mean to malign physicians from the entire country of Nepal.” More than 2700 people have signed the petition.

A version of this article appeared on Medscape.com.

I recently received an email from a distraught physician. Several months previously, he had sold his practice to a large private equity-funded group. The terms spelled out in the group’s letter of intent (LOI) seemed ideal. He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.

When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.

The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.

When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”

There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.

You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.

When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.

Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.

This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.

Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.

While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.

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

I recently received an email from a distraught physician. Several months previously, he had sold his practice to a large private equity-funded group. The terms spelled out in the group’s letter of intent (LOI) seemed ideal. He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.

When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.

The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.

When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”

There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.

You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.

When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.

Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.

This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.

Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.

While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.

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

I recently received an email from a distraught physician. Several months previously, he had sold his practice to a large private equity-funded group. The terms spelled out in the group’s letter of intent (LOI) seemed ideal. He could continue running his office any way he wished, set his own hours and fees, and keep his employees. All his overhead expenses would disappear. His income would remain the same, maybe even increase. He signed it eagerly.

When he received the actual sale and employment contracts, none of the details promised in the LOI were included; but he figured that since they were spelled out in the LOI, which both he and the buyer had signed, he was covered. His attorney — a family friend with no experience in medical practice transactions — approved the documents.

The deal seemed too good to be true, and it was. The day after the sale closed, all his employees received termination notices. The group offered to rehire some of them, but at lower salaries and reduced benefits. (Most declined.) The new staffers he received were inadequately trained and unfamiliar with his standard office procedures. Patients complained that fees had increased substantially. His own compensation was contingent on meeting strict billing and performance goals. Malpractice premiums remained his responsibility. His office hours were lengthened to include evenings and Saturday mornings.

When he complained to the group that none of the things promised in the LOI had been delivered, he was informed that the LOI was not legally binding. In fact, the sale and employment contracts both clearly specified that they “replaced any previous written or oral agreements between the parties.”

There are some valuable lessons to be learned here. First, whether you are a young physician seeking a new job with a hospital or large practice, or an older one looking to sell an established practice, retain an attorney experienced in medical transactions early, before you sign anything, binding or not. Second, recognize that any promises made in an LOI must be spelled out in the employment and/or sale contract as well.

You might ask, if the terms in an LOI are not binding, why bother with one at all? For one thing, you want to make sure that you and your potential employer or buyer are on the same page with respect to major terms before you get down to details in the employment agreement and/or the medical practice sale agreement. For another, in most states certain LOI provisions are legally binding. For example, the document will most likely provide that each party is responsible for its own attorneys’ fees and for maintaining confidentiality during the negotiations, and that you will not negotiate with any other parties for some specified period of time. In most cases, such provisions are binding whether you go on to sign a formal contract or not.

When you receive an LOI, go through it carefully and identify areas of concern. The offering party will likely be in a rush to sign you up; but once you sign, you won’t be able to negotiate with anyone else for a while, which weakens your negotiating position. Regardless of what is said about time being “of the essence,” proceed slowly and with caution.

Bear in mind that employers and buyers never begin with their best offer. Unless you have been through this before, it is unlikely that you will know your value as an employee or the value of your practice, or what exactly you are entitled to ask for. Rather than signing something you don’t completely understand, explain to the offering party that you need time to consider and evaluate their offer.

This is the time to hire a competent medical attorney to do some due diligence on the offering party and review their offer, and to educate yourself about practice value and compensation benchmarks in your area. You and your counsel should assemble a list of things that you want changed in the LOI, then present them to the other side. They should be amenable to negotiation. If they are not (as was the case in the example presented earlier), you should reconsider whether you really want to be associated with that particular buyer or employer.

Once you have signed the LOI, experts say speed then works to your advantage. “Time kills all deals,” as one lawyer put it. “The longer it takes to close the transaction, the more that can go wrong.” The prospective employer or buyer could uncover information about you or your practice that decreases their perception of value, or economic conditions might change.

While speed is now important, and most of the core issues should already have been resolved in the LOI, don’t be afraid to ask for everything you want, whether it’s a better sale price, higher compensation, a favorable call schedule, more vacation time, or anything else. You won’t know what you can get if you don’t ask for it.

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

Implementing strategies to optimize electronic health record (EHR) use can save time, improve the doctor-patient relationship, and reduce burnout, a new practice management article suggests.

Michelle Kang Kim, MD, PhD, AGAF, chair of gastroenterology at Cleveland Clinic, Ohio, and colleagues provide EHR improvement strategies and examples that can be adapted for use in a variety of gastroenterology clinic settings. 

Their article, which was published online in Clinical Gastroenterology and Hepatology , includes the following suggestions, among others:

• Develop optimization teams. An example is SPRINT, a short, intensive team-based intervention at the University of Colorado Health, Aurora, Colorado, that developed specialty-specific tools, provided EHR efficiency training, and helped streamline workflows. The optimization project increased EHR satisfaction scores and reduced documentation time.
• Reroute low-acuity messages. Low-risk medication refills or appointment requests can be handled by nurses and medical assistants. This strategy has helped reduce the inbox burden.
• Create order sets for complex treatment dosing. One example is Cleveland Clinic’s Helicobacter pylori order set, which enables clinicians to quickly place orders with built-in dosages.
• Personalize EHR drop-down menus. Incorporate inflammatory bowel disease (IBD) severity scores, biopsy sampling, resection protocols, specimen container numbering, and other workflow-specific documentation into the EHR.
• Employ medical scribes. These professionals can serve as personal assistants, supporting care teams and reducing clinician documentation time. Alternatively, clinical support staff, such as nurses, can assist with documentation and messages, helping to reduce physician burnout. “These models could be particularly useful in GI specialties that require a multidisciplinary approach, for example, IBD and hepatology,” the authors write.
• Provide real-time training on best practices. There is no widely accepted EHR training curriculum for students, and experienced physicians face time constraints in learning new practices. Real-time training can help clinicians at all levels optimize their time outside the clinic.

In addition, the authors addressed novel tools and strategies that have been recently deployed and/or are in development, which are based largely on artificial intelligence (AI), natural language processing, and speech recognition. For now, these tools are digitizing data to help automate some EHR tasks, supporting communications with patients, and assisting in clinical decision making.

However, the authors note that although current optimization tools are promising, “there is still a lack of knowledge about their usability and effects on provider and patient well-being. More research is needed to evaluate current methodologies and design intelligent tools for the future that will help GI providers overcome the EHR-related obstacles specific to our field and harness the enormous potential of AI in optimizing the busy GI practice.”

This work received no external funding, and the authors disclosed no conflicts. 

A version of this article appeared on Medscape.com.

Implementing strategies to optimize electronic health record (EHR) use can save time, improve the doctor-patient relationship, and reduce burnout, a new practice management article suggests.

Michelle Kang Kim, MD, PhD, AGAF, chair of gastroenterology at Cleveland Clinic, Ohio, and colleagues provide EHR improvement strategies and examples that can be adapted for use in a variety of gastroenterology clinic settings. 

Their article, which was published online in Clinical Gastroenterology and Hepatology , includes the following suggestions, among others:

• Develop optimization teams. An example is SPRINT, a short, intensive team-based intervention at the University of Colorado Health, Aurora, Colorado, that developed specialty-specific tools, provided EHR efficiency training, and helped streamline workflows. The optimization project increased EHR satisfaction scores and reduced documentation time.
• Reroute low-acuity messages. Low-risk medication refills or appointment requests can be handled by nurses and medical assistants. This strategy has helped reduce the inbox burden.
• Create order sets for complex treatment dosing. One example is Cleveland Clinic’s Helicobacter pylori order set, which enables clinicians to quickly place orders with built-in dosages.
• Personalize EHR drop-down menus. Incorporate inflammatory bowel disease (IBD) severity scores, biopsy sampling, resection protocols, specimen container numbering, and other workflow-specific documentation into the EHR.
• Employ medical scribes. These professionals can serve as personal assistants, supporting care teams and reducing clinician documentation time. Alternatively, clinical support staff, such as nurses, can assist with documentation and messages, helping to reduce physician burnout. “These models could be particularly useful in GI specialties that require a multidisciplinary approach, for example, IBD and hepatology,” the authors write.
• Provide real-time training on best practices. There is no widely accepted EHR training curriculum for students, and experienced physicians face time constraints in learning new practices. Real-time training can help clinicians at all levels optimize their time outside the clinic.

In addition, the authors addressed novel tools and strategies that have been recently deployed and/or are in development, which are based largely on artificial intelligence (AI), natural language processing, and speech recognition. For now, these tools are digitizing data to help automate some EHR tasks, supporting communications with patients, and assisting in clinical decision making.

However, the authors note that although current optimization tools are promising, “there is still a lack of knowledge about their usability and effects on provider and patient well-being. More research is needed to evaluate current methodologies and design intelligent tools for the future that will help GI providers overcome the EHR-related obstacles specific to our field and harness the enormous potential of AI in optimizing the busy GI practice.”

This work received no external funding, and the authors disclosed no conflicts. 

A version of this article appeared on Medscape.com.

Implementing strategies to optimize electronic health record (EHR) use can save time, improve the doctor-patient relationship, and reduce burnout, a new practice management article suggests.

Michelle Kang Kim, MD, PhD, AGAF, chair of gastroenterology at Cleveland Clinic, Ohio, and colleagues provide EHR improvement strategies and examples that can be adapted for use in a variety of gastroenterology clinic settings. 

Their article, which was published online in Clinical Gastroenterology and Hepatology , includes the following suggestions, among others:

• Develop optimization teams. An example is SPRINT, a short, intensive team-based intervention at the University of Colorado Health, Aurora, Colorado, that developed specialty-specific tools, provided EHR efficiency training, and helped streamline workflows. The optimization project increased EHR satisfaction scores and reduced documentation time.
• Reroute low-acuity messages. Low-risk medication refills or appointment requests can be handled by nurses and medical assistants. This strategy has helped reduce the inbox burden.
• Create order sets for complex treatment dosing. One example is Cleveland Clinic’s Helicobacter pylori order set, which enables clinicians to quickly place orders with built-in dosages.
• Personalize EHR drop-down menus. Incorporate inflammatory bowel disease (IBD) severity scores, biopsy sampling, resection protocols, specimen container numbering, and other workflow-specific documentation into the EHR.
• Employ medical scribes. These professionals can serve as personal assistants, supporting care teams and reducing clinician documentation time. Alternatively, clinical support staff, such as nurses, can assist with documentation and messages, helping to reduce physician burnout. “These models could be particularly useful in GI specialties that require a multidisciplinary approach, for example, IBD and hepatology,” the authors write.
• Provide real-time training on best practices. There is no widely accepted EHR training curriculum for students, and experienced physicians face time constraints in learning new practices. Real-time training can help clinicians at all levels optimize their time outside the clinic.

In addition, the authors addressed novel tools and strategies that have been recently deployed and/or are in development, which are based largely on artificial intelligence (AI), natural language processing, and speech recognition. For now, these tools are digitizing data to help automate some EHR tasks, supporting communications with patients, and assisting in clinical decision making.

However, the authors note that although current optimization tools are promising, “there is still a lack of knowledge about their usability and effects on provider and patient well-being. More research is needed to evaluate current methodologies and design intelligent tools for the future that will help GI providers overcome the EHR-related obstacles specific to our field and harness the enormous potential of AI in optimizing the busy GI practice.”

This work received no external funding, and the authors disclosed no conflicts. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

FDA

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.

Healthcare workers have been at an increased risk for SARS-CoV-2 infection and mental distress such as anxiety and depression during the pandemic, according to new research.

In an analysis of administrative health records for about 3000 healthcare workers in Alberta, Canada, the workers were as much as twice as likely to become infected with SARS-CoV-2 compared with the overall population. The risk for infection was higher among healthcare workers in the first two waves of the pandemic and again during the fifth wave.

“Previous publications, including ours, suggested that the main problem was in the early weeks and months of the pandemic, but this paper shows that it continued until the later stages,” senior author Nicola Cherry, MD, an occupational epidemiologist at the University of Alberta in Edmonton, Canada, told this news organization.

The findings were published in the Canadian Journal of Public Health.
 

Wave Upon Wave

In the current study, the investigators sought to compare the risk for SARS-CoV-2 infection and mental distress among healthcare workers and among community referents (CRs). They examined the following waves of the COVID-19 pandemic:

• Wave 1: From March to June 2020 (4 months).
• Wave 2: From July 2020 to February 2021 (8 months).
• Wave 3: From March to June 2021 (4 months).
• Wave 4: From July to October 2021 (4 months).
• Wave 5 (Omicron): From November 2021 to March 2022 (5 months).

Healthcare workers in Alberta were asked at recruitment for consent to match their individual records to the Alberta Administrative Health Database. As the pandemic progressed, participants were also asked for consent to be linked to COVID-19 immunization records maintained by the provinces, as well as for the results of all polymerase chain reaction (PCR) testing for the SARS-CoV-2 virus.

The investigators matched 2959 healthcare workers to 14,546 CRs according to their age, sex, geographic location in Alberta, and number of physician claims from April 1, 2019, to March 31, 2020.

Incident SARS-CoV-2 infection was examined using PCR testing and the first date of a physician consultation at which the code for SARS-CoV-2 infection had been recorded. Mental health disorders were identified from physician records. They included anxiety disorders, stress and adjustment reactions, and depressive disorders.

Most (79.5%) of the healthcare workers were registered nurses, followed by physicians (16.1%), healthcare aides (2.4%), and licensed practical nurses (2.0%). Most participants (87.5%) were female. The median age at recruitment was 44 years.

Healthcare workers were at a greater risk for COVID-19 overall, with the first SARS-CoV-2 infection defined from either PCR tests (odds ratio [OR], 1.96) or from physician records (OR, 1.33). They were also at an increased risk for anxiety (adjusted OR, 1.25; P < .001), stress/adjustment reaction (adjusted OR, 1.52; P < .001), and depressive condition (adjusted OR, 1.39; P < .001). Moreover, the excess risks for stress/adjustment reactions and depressive conditions increased with successive waves during the pandemic, peaking in the fourth wave and continuing in the fifth wave.

“Although the increase was less in the middle of the phases of the pandemic, it came back with a vengeance during the last phase, which was the Omicron phase,” said Dr. Cherry.

“Employers of healthcare workers can’t assume that everything is now under control, that they know what they’re doing, and that there is no risk. We are now having some increases in COVID. It’s going to go on. The pandemic is not over in that sense, and infection control continues to be major,” she added.

The finding that mental health worsened among healthcare workers was not surprising, Dr. Cherry said. Even before the pandemic, studies had shown that healthcare workers were at a greater risk for depression than the population overall.

“There is a lot of need for care in mental health support of healthcare workers, whether during a pandemic or not,” said Dr. Cherry.
 

Nurses Are Suffering

Commenting on the research for this news organization, Farinaz Havaei, PhD, RN, assistant professor of nursing at the University of British Columbia in Vancouver, Canada, said, “This is a very important and timely study that draws on objective clinical and administrative data, as opposed to healthcare workers’ subjective reports.” Dr. Havaei did not participate in the research.

Overall, the findings are consistent with previous research that drew upon healthcare workers’ reports. They speak to the chronic and cumulative impact of COVID-19 and its associated stressors on the mental health and well-being of healthcare workers, said Dr. Havaei.

“The likelihood of stress/adjustment reaction and depression showed a relatively steady increase with increasing COVID-19 waves. This increase can likely be explained by healthcare workers’ depleting emotional reserves for coping with chronic workplace stressors such as concerns about exposure to COVID-19, inadequate staffing, and work overload,” she said. Witnessing the suffering and trauma of patients and their families likely added to this risk.

Dr. Havaei also pointed out that most of the study participants were nurses. The findings are consistent with prepandemic research that showed that the suboptimal conditions that nurses increasingly faced resulted in high levels of exhaustion and burnout.

“While I agree with the authors’ call for more mental health support for healthcare workers, I think prevention efforts that address the root cause of the problem should be prioritized,” she said.
 

From Heroes to Zeros

The same phenomena have been observed in the United States, said John Q. Young, MD, MPP, PhD, professor and chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York. In various studies, Dr. Young and his colleagues have reported a strong association between exposure to the stressors of the pandemic and subsequent development of depression, anxiety, and posttraumatic stress disorder (PTSD) among healthcare workers.

“The findings from Alberta are remarkably consistent. In the beginning of the pandemic, there was a lot of acknowledgment of the work healthcare workers were doing. The fire department clapping as you leave work at night, being called heroes, even though a lot of healthcare workers feel uncomfortable with the hero language because they don’t feel like heroes. Yes, they’re afraid, but they are going to do what they need to do and help,” he said.

But as the pandemic continued, public sentiment changed, Dr. Young said. “They’ve gone from heroes to zeros. Now we are seeing the accumulated, chronic effects over months and years, and these are significant. Our healthcare workforce is vulnerable now. The reserves are low. There are serious shortages in nursing, with more retirements and more people leaving the field,” he said.

As part of a campaign to help healthcare workers cope, psychiatrists at Northwell Health have started a program called Stress First Aid at their Center for Traumatic Stress Response Resilience, where they train nurses, physicians, and other healthcare staff to use basic tools to recognize and respond to stress and distress in themselves and in their colleagues, said Dr. Young.

“For those healthcare workers who find that they are struggling and need more support, there is resilience coaching, which is one-on-one support. For those who need more clinical attention, there is a clinical program where our healthcare workers can meet with a psychologist, psychiatrist, or a therapist, to work through depression, PTSD, and anxiety. We didn’t have this before the pandemic, but it is now a big focus for our workforce,” he said. “We are trying to build resilience. The trauma is real.”

The study was supported by the College of Physicians and Surgeons of Alberta, the Canadian Institutes of Health Research, and the Canadian Immunology Task Force. Dr. Cherry and Dr. Havaei reported no relevant financial relationships. Dr. Young reported that he is senior vice president of behavioral health at Northwell.

A version of this article appeared on Medscape.com.