Mixed Topics

Reports of a small number of patients developing secondary T-cell malignancies following treatment with chimeric antigen receptor (CAR) T-cell immunotherapy have raised concerns and prompted a class-wide boxed warning to the labeling of the therapies by the US Food and Drug Administration (FDA), but for now experts underscore that the benefits of the groundbreaking therapies still appear to well outweigh the risks.

Importantly, most specialists agree, so far the risk appears no greater than the known risk of secondary primary malignancies that is well established with other cancer therapies.

“The data that we have so far suggest that the risk of secondary T-cell lymphoma in patients treated with CAR T-cells is similar to [that] of patients treated with other cancer therapies, [including] chemotherapy, radiation, transplantation,” Marco Ruella, MD, said in an interview. He reported on a case of a T-cell lymphoma occurring following CAR-T therapy at the University of Pennsylvania.

While his team is still investigating the development of such malignancies, “the FDA notice does not change our clinical practice and patients should be reassured that the benefit of CAR-T therapy significantly outweighs the potential risk of secondary malignancies including T-cell lymphoma,” said Dr. Ruella, scientific director of the Lymphoma Program, Division of Hematology and Oncology and Center for Cellular Immunotherapies, at the University of Pennsylvania, Philadelphia.
 

FDA: 28 Reports of Malignancies; 3 with Evidence of ‘Likely’ CAR T Involvement

Concerns were raised last November when the FDA announced in a safety communication that it was investigating the “serious risk of T-cell malignancy” following B-cell maturation antigen (BCMA)-directed or CD19-directed CAR T-cell immunotherapies, citing reports from clinical trials and/or postmarketing adverse event data sources. Subsequently, in January, the FDA called for the boxed warning on all approved BCMA- and CD19-targeted genetically modified autologous T-cell immunotherapies, which include: Abecma (idecabtagene vicleucel); Breyanzi (lisocabtagene maraleucel); Carvykti (ciltacabtagene autoleucel); Kymriah (tisagenlecleucel); Tecartus (brexucabtagene autoleucel); and Yescarta (axicabtagene ciloleucel).

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA continues to investigate the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death,” the FDA reported in discussing the safety warnings.

The cases were detailed in a report from FDA researchers published in the New England Journal of Medicine, noting that as of December 31, 2023, the FDA had become aware of 22 cases of T-cell cancers occurring following CAR T-cell treatment, including T-cell lymphoma, T-cell large granular lymphocytosis, peripheral T-cell lymphoma, and cutaneous T-cell lymphoma.

Report coauthor Peter Marks, MD, PhD, of the FDA’s Center for Biologics Evaluation and Research in Silver Spring, Maryland, said in an interview that since the publication of their report, six new cases have emerged.

“As reported in the NEJM Perspective, there were 22 cases of T-cell malignancy after treatment with CAR T-cell immunotherapies as of December 31, 2023, but we have received additional reports and, as of February 9, 2024, FDA has now received 28 reports,” he said. “Note that as new cases are being reported, there will be updates to the total number of cases under ongoing review by FDA.”

The initial 22 cases all occurred relatively soon after treatment. Of 14 cases with sufficient data, all developed within 2 years of the CAR-T therapy, ranging from 1 to 19 months, with about half occurring in the first year after administration.

The cases involved five of the six FDA-approved CAR-T products, with the numbers too low to suggest an association with any particular product.

In three of the cases, the lymphoma was found in genetic testing to contain the CAR construction, “indicating that the CAR-T product was most likely involved in the development of the T-cell cancer,” according to the FDA researchers.

With inadequate genetic sampling in most of the remaining 19 cases, the association is less clear, however “the timing of several of the cases makes association a possibility,” Dr. Marks said. In their report, Dr. Marks and colleagues added that “determination of whether the T-cell cancer is associated with the CAR construct ... most likely won’t be possible for every case reported to date.”

Even if all the reported cases are assumed to be related to CAR-T treatment, the numbers still represent a very small proportion of the more than 27,000 doses of the six CAR-T therapies approved in the United States, the authors noted, but they cautioned that the numbers could indeed be higher than reported.

“Relying on postmarketing reporting may lead to underestimates of such cases,” they said.
 

Life-Long Monitoring Recommended

In response to the reports, the FDA is urging that clinicians’ monitoring of patients treated with CAR-T therapy should be lifelong.

“Patients and clinical trial participants receiving treatment with these products should be monitored lifelong for new malignancies,” Dr. Marks said.

“In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the CAR transgene.”

In addition, cases should be reported to the FDA, either by calling or through the FDA’s medical product safety reporting program.
 

T-Cell Malignancy Case Report

In describing the case at their medical center in the report in Nature Medicine, Dr. Ruella and colleagues said a T-cell lymphoma occurred in a patient with non-Hodgkin B-cell lymphoma 3 months after an anti-CD19 CAR T-cell treatment.

As a result, the team conducted a subsequent analysis of 449 patients treated with CAR-T therapy at the University of Pennsylvania center, and with a median follow-up of 10.3 months, 16 patients (3.6%) had developed a secondary primary malignancy, with a median onset time of 26.4 months for solid and 9.7 months for hematological malignancies.

The patient who had developed a T-cell lymphoma tested negative for CAR integration upon diagnosis, and regarding the other cancers, Dr. Ruella noted that “we have no indication that the secondary malignancies are directly caused by the CAR-T therapy.

“We have many patients with a very long follow-up beyond 5 and even 10 years,” he said. “In these patients, we don’t see an increased risk of T-cell lymphoma.”
 

‘Cautious Reassurance’ Urged in Discussion with Patients

With alarming headlines on the findings suggesting that CAR-T therapy may cause cancer, Rahul Banerjee, MD, and colleagues at the University of Washington, Seattle, recommend the use of “cautious reassurance” in discussing the issue with patients. In a paper published in January in Blood Advances, they suggest a three-part response: underscoring that the benefits of CAR T “far outweigh” the risks in relapsed/refractory malignancies, that the ‘one-and-done’ nature of CAR-T infusions provide meaningful improvements in quality of life, and that the active cancer at hand is “a much larger threat than a hypothetical cancer years later.”

In many cases, patients may only have months to live without CAR-T therapy and will have already had multiple prior lines of therapy, therefore the CAR-T treatment itself may provide time for the secondary primary cancers from any of the treatments to emerge, as experts have noted.

“One has to be alive to be diagnosed with a secondary primary malignancy, and it’s thus very possible that CAR-T may be creating a type of ‘immortal time bias’ wherein patients live long enough to experience the unfortunate sequelae of their previous therapies,” Dr. Banerjee explained in an interview.

Nevertheless, the potential for substantial improvements in quality of life with CAR-T therapy compared with traditional treatments addresses a top priority for patients, he added.

“For most patients with [for instance], myeloma, the ability of CAR-T to put them rapidly into a deep remission without the need for maintenance is an unheard-of potential for them,” Dr. Banerjee said.

“In multiple myeloma, no CAR-T therapy has (yet) demonstrated an overall survival benefit — but I think the substantial quality-of-life benefit stands by itself as a big reason why patients continue to prefer CAR-T.”
 

Keep Patients In Touch with CAR T Centers

In light of the concerns regarding the secondary malignancies, Dr. Banerjee underscored that CAR-T patients should be kept in close touch with centers that have CAR-T treatment expertise.

With most patients followed primarily at community practices where CAR-T therapy is not administered, “I’d strongly encourage my colleagues in community practices to refer all eligible patients to a CAR-T-capable center for evaluation regardless of what their risk of post-CAR-T secondary primary malignancies may be,” Dr. Banerjee urged.

“Based on the evidence we have currently, which includes the FDA’s updated information, there are many more unknowns about this potential secondary primary malignancy risk than knowns,” he said. “This is of course a much more nuanced issue than any one package insert can convey, and CAR-T experts at treating centers can have these conversations at length with eligible patients who are nervous about these recent updates.”

Dr. Ruella disclosed that he holds patents related to CD19 CAR T cells, as well as relationships with NanoString, Bristol Myers Squibb, GlaxoSmithKline, Scailyte, Bayer, AbClon, Oxford NanoImaging, CURIOX, and Beckman Coulter, and he was the scientific founder of viTToria Biotherapeutics. Dr. Banerjee reported ties with BMS, Caribou Biosciences, Genentech, Janssen, Karyopharm, Pfizer, Sanofi, SparkCures, Novartis, and Pack Health.

Reports of a small number of patients developing secondary T-cell malignancies following treatment with chimeric antigen receptor (CAR) T-cell immunotherapy have raised concerns and prompted a class-wide boxed warning to the labeling of the therapies by the US Food and Drug Administration (FDA), but for now experts underscore that the benefits of the groundbreaking therapies still appear to well outweigh the risks.

Importantly, most specialists agree, so far the risk appears no greater than the known risk of secondary primary malignancies that is well established with other cancer therapies.

“The data that we have so far suggest that the risk of secondary T-cell lymphoma in patients treated with CAR T-cells is similar to [that] of patients treated with other cancer therapies, [including] chemotherapy, radiation, transplantation,” Marco Ruella, MD, said in an interview. He reported on a case of a T-cell lymphoma occurring following CAR-T therapy at the University of Pennsylvania.

While his team is still investigating the development of such malignancies, “the FDA notice does not change our clinical practice and patients should be reassured that the benefit of CAR-T therapy significantly outweighs the potential risk of secondary malignancies including T-cell lymphoma,” said Dr. Ruella, scientific director of the Lymphoma Program, Division of Hematology and Oncology and Center for Cellular Immunotherapies, at the University of Pennsylvania, Philadelphia.
 

FDA: 28 Reports of Malignancies; 3 with Evidence of ‘Likely’ CAR T Involvement

Concerns were raised last November when the FDA announced in a safety communication that it was investigating the “serious risk of T-cell malignancy” following B-cell maturation antigen (BCMA)-directed or CD19-directed CAR T-cell immunotherapies, citing reports from clinical trials and/or postmarketing adverse event data sources. Subsequently, in January, the FDA called for the boxed warning on all approved BCMA- and CD19-targeted genetically modified autologous T-cell immunotherapies, which include: Abecma (idecabtagene vicleucel); Breyanzi (lisocabtagene maraleucel); Carvykti (ciltacabtagene autoleucel); Kymriah (tisagenlecleucel); Tecartus (brexucabtagene autoleucel); and Yescarta (axicabtagene ciloleucel).

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA continues to investigate the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death,” the FDA reported in discussing the safety warnings.

The cases were detailed in a report from FDA researchers published in the New England Journal of Medicine, noting that as of December 31, 2023, the FDA had become aware of 22 cases of T-cell cancers occurring following CAR T-cell treatment, including T-cell lymphoma, T-cell large granular lymphocytosis, peripheral T-cell lymphoma, and cutaneous T-cell lymphoma.

Report coauthor Peter Marks, MD, PhD, of the FDA’s Center for Biologics Evaluation and Research in Silver Spring, Maryland, said in an interview that since the publication of their report, six new cases have emerged.

“As reported in the NEJM Perspective, there were 22 cases of T-cell malignancy after treatment with CAR T-cell immunotherapies as of December 31, 2023, but we have received additional reports and, as of February 9, 2024, FDA has now received 28 reports,” he said. “Note that as new cases are being reported, there will be updates to the total number of cases under ongoing review by FDA.”

The initial 22 cases all occurred relatively soon after treatment. Of 14 cases with sufficient data, all developed within 2 years of the CAR-T therapy, ranging from 1 to 19 months, with about half occurring in the first year after administration.

The cases involved five of the six FDA-approved CAR-T products, with the numbers too low to suggest an association with any particular product.

In three of the cases, the lymphoma was found in genetic testing to contain the CAR construction, “indicating that the CAR-T product was most likely involved in the development of the T-cell cancer,” according to the FDA researchers.

With inadequate genetic sampling in most of the remaining 19 cases, the association is less clear, however “the timing of several of the cases makes association a possibility,” Dr. Marks said. In their report, Dr. Marks and colleagues added that “determination of whether the T-cell cancer is associated with the CAR construct ... most likely won’t be possible for every case reported to date.”

Even if all the reported cases are assumed to be related to CAR-T treatment, the numbers still represent a very small proportion of the more than 27,000 doses of the six CAR-T therapies approved in the United States, the authors noted, but they cautioned that the numbers could indeed be higher than reported.

“Relying on postmarketing reporting may lead to underestimates of such cases,” they said.
 

Life-Long Monitoring Recommended

In response to the reports, the FDA is urging that clinicians’ monitoring of patients treated with CAR-T therapy should be lifelong.

“Patients and clinical trial participants receiving treatment with these products should be monitored lifelong for new malignancies,” Dr. Marks said.

“In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the CAR transgene.”

In addition, cases should be reported to the FDA, either by calling or through the FDA’s medical product safety reporting program.
 

T-Cell Malignancy Case Report

In describing the case at their medical center in the report in Nature Medicine, Dr. Ruella and colleagues said a T-cell lymphoma occurred in a patient with non-Hodgkin B-cell lymphoma 3 months after an anti-CD19 CAR T-cell treatment.

As a result, the team conducted a subsequent analysis of 449 patients treated with CAR-T therapy at the University of Pennsylvania center, and with a median follow-up of 10.3 months, 16 patients (3.6%) had developed a secondary primary malignancy, with a median onset time of 26.4 months for solid and 9.7 months for hematological malignancies.

The patient who had developed a T-cell lymphoma tested negative for CAR integration upon diagnosis, and regarding the other cancers, Dr. Ruella noted that “we have no indication that the secondary malignancies are directly caused by the CAR-T therapy.

“We have many patients with a very long follow-up beyond 5 and even 10 years,” he said. “In these patients, we don’t see an increased risk of T-cell lymphoma.”
 

‘Cautious Reassurance’ Urged in Discussion with Patients

With alarming headlines on the findings suggesting that CAR-T therapy may cause cancer, Rahul Banerjee, MD, and colleagues at the University of Washington, Seattle, recommend the use of “cautious reassurance” in discussing the issue with patients. In a paper published in January in Blood Advances, they suggest a three-part response: underscoring that the benefits of CAR T “far outweigh” the risks in relapsed/refractory malignancies, that the ‘one-and-done’ nature of CAR-T infusions provide meaningful improvements in quality of life, and that the active cancer at hand is “a much larger threat than a hypothetical cancer years later.”

In many cases, patients may only have months to live without CAR-T therapy and will have already had multiple prior lines of therapy, therefore the CAR-T treatment itself may provide time for the secondary primary cancers from any of the treatments to emerge, as experts have noted.

“One has to be alive to be diagnosed with a secondary primary malignancy, and it’s thus very possible that CAR-T may be creating a type of ‘immortal time bias’ wherein patients live long enough to experience the unfortunate sequelae of their previous therapies,” Dr. Banerjee explained in an interview.

Nevertheless, the potential for substantial improvements in quality of life with CAR-T therapy compared with traditional treatments addresses a top priority for patients, he added.

“For most patients with [for instance], myeloma, the ability of CAR-T to put them rapidly into a deep remission without the need for maintenance is an unheard-of potential for them,” Dr. Banerjee said.

“In multiple myeloma, no CAR-T therapy has (yet) demonstrated an overall survival benefit — but I think the substantial quality-of-life benefit stands by itself as a big reason why patients continue to prefer CAR-T.”
 

Keep Patients In Touch with CAR T Centers

In light of the concerns regarding the secondary malignancies, Dr. Banerjee underscored that CAR-T patients should be kept in close touch with centers that have CAR-T treatment expertise.

With most patients followed primarily at community practices where CAR-T therapy is not administered, “I’d strongly encourage my colleagues in community practices to refer all eligible patients to a CAR-T-capable center for evaluation regardless of what their risk of post-CAR-T secondary primary malignancies may be,” Dr. Banerjee urged.

“Based on the evidence we have currently, which includes the FDA’s updated information, there are many more unknowns about this potential secondary primary malignancy risk than knowns,” he said. “This is of course a much more nuanced issue than any one package insert can convey, and CAR-T experts at treating centers can have these conversations at length with eligible patients who are nervous about these recent updates.”

Dr. Ruella disclosed that he holds patents related to CD19 CAR T cells, as well as relationships with NanoString, Bristol Myers Squibb, GlaxoSmithKline, Scailyte, Bayer, AbClon, Oxford NanoImaging, CURIOX, and Beckman Coulter, and he was the scientific founder of viTToria Biotherapeutics. Dr. Banerjee reported ties with BMS, Caribou Biosciences, Genentech, Janssen, Karyopharm, Pfizer, Sanofi, SparkCures, Novartis, and Pack Health.

Reports of a small number of patients developing secondary T-cell malignancies following treatment with chimeric antigen receptor (CAR) T-cell immunotherapy have raised concerns and prompted a class-wide boxed warning to the labeling of the therapies by the US Food and Drug Administration (FDA), but for now experts underscore that the benefits of the groundbreaking therapies still appear to well outweigh the risks.

Importantly, most specialists agree, so far the risk appears no greater than the known risk of secondary primary malignancies that is well established with other cancer therapies.

“The data that we have so far suggest that the risk of secondary T-cell lymphoma in patients treated with CAR T-cells is similar to [that] of patients treated with other cancer therapies, [including] chemotherapy, radiation, transplantation,” Marco Ruella, MD, said in an interview. He reported on a case of a T-cell lymphoma occurring following CAR-T therapy at the University of Pennsylvania.

While his team is still investigating the development of such malignancies, “the FDA notice does not change our clinical practice and patients should be reassured that the benefit of CAR-T therapy significantly outweighs the potential risk of secondary malignancies including T-cell lymphoma,” said Dr. Ruella, scientific director of the Lymphoma Program, Division of Hematology and Oncology and Center for Cellular Immunotherapies, at the University of Pennsylvania, Philadelphia.
 

FDA: 28 Reports of Malignancies; 3 with Evidence of ‘Likely’ CAR T Involvement

Concerns were raised last November when the FDA announced in a safety communication that it was investigating the “serious risk of T-cell malignancy” following B-cell maturation antigen (BCMA)-directed or CD19-directed CAR T-cell immunotherapies, citing reports from clinical trials and/or postmarketing adverse event data sources. Subsequently, in January, the FDA called for the boxed warning on all approved BCMA- and CD19-targeted genetically modified autologous T-cell immunotherapies, which include: Abecma (idecabtagene vicleucel); Breyanzi (lisocabtagene maraleucel); Carvykti (ciltacabtagene autoleucel); Kymriah (tisagenlecleucel); Tecartus (brexucabtagene autoleucel); and Yescarta (axicabtagene ciloleucel).

“Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA continues to investigate the identified risk of T-cell malignancy with serious outcomes, including hospitalization and death,” the FDA reported in discussing the safety warnings.

The cases were detailed in a report from FDA researchers published in the New England Journal of Medicine, noting that as of December 31, 2023, the FDA had become aware of 22 cases of T-cell cancers occurring following CAR T-cell treatment, including T-cell lymphoma, T-cell large granular lymphocytosis, peripheral T-cell lymphoma, and cutaneous T-cell lymphoma.

Report coauthor Peter Marks, MD, PhD, of the FDA’s Center for Biologics Evaluation and Research in Silver Spring, Maryland, said in an interview that since the publication of their report, six new cases have emerged.

“As reported in the NEJM Perspective, there were 22 cases of T-cell malignancy after treatment with CAR T-cell immunotherapies as of December 31, 2023, but we have received additional reports and, as of February 9, 2024, FDA has now received 28 reports,” he said. “Note that as new cases are being reported, there will be updates to the total number of cases under ongoing review by FDA.”

The initial 22 cases all occurred relatively soon after treatment. Of 14 cases with sufficient data, all developed within 2 years of the CAR-T therapy, ranging from 1 to 19 months, with about half occurring in the first year after administration.

The cases involved five of the six FDA-approved CAR-T products, with the numbers too low to suggest an association with any particular product.

In three of the cases, the lymphoma was found in genetic testing to contain the CAR construction, “indicating that the CAR-T product was most likely involved in the development of the T-cell cancer,” according to the FDA researchers.

With inadequate genetic sampling in most of the remaining 19 cases, the association is less clear, however “the timing of several of the cases makes association a possibility,” Dr. Marks said. In their report, Dr. Marks and colleagues added that “determination of whether the T-cell cancer is associated with the CAR construct ... most likely won’t be possible for every case reported to date.”

Even if all the reported cases are assumed to be related to CAR-T treatment, the numbers still represent a very small proportion of the more than 27,000 doses of the six CAR-T therapies approved in the United States, the authors noted, but they cautioned that the numbers could indeed be higher than reported.

“Relying on postmarketing reporting may lead to underestimates of such cases,” they said.
 

Life-Long Monitoring Recommended

In response to the reports, the FDA is urging that clinicians’ monitoring of patients treated with CAR-T therapy should be lifelong.

“Patients and clinical trial participants receiving treatment with these products should be monitored lifelong for new malignancies,” Dr. Marks said.

“In the event that a new malignancy occurs following treatment with these products, contact the manufacturer to report the event and obtain instructions on collection of patient samples for testing for the presence of the CAR transgene.”

In addition, cases should be reported to the FDA, either by calling or through the FDA’s medical product safety reporting program.
 

T-Cell Malignancy Case Report

In describing the case at their medical center in the report in Nature Medicine, Dr. Ruella and colleagues said a T-cell lymphoma occurred in a patient with non-Hodgkin B-cell lymphoma 3 months after an anti-CD19 CAR T-cell treatment.

As a result, the team conducted a subsequent analysis of 449 patients treated with CAR-T therapy at the University of Pennsylvania center, and with a median follow-up of 10.3 months, 16 patients (3.6%) had developed a secondary primary malignancy, with a median onset time of 26.4 months for solid and 9.7 months for hematological malignancies.

The patient who had developed a T-cell lymphoma tested negative for CAR integration upon diagnosis, and regarding the other cancers, Dr. Ruella noted that “we have no indication that the secondary malignancies are directly caused by the CAR-T therapy.

“We have many patients with a very long follow-up beyond 5 and even 10 years,” he said. “In these patients, we don’t see an increased risk of T-cell lymphoma.”
 

‘Cautious Reassurance’ Urged in Discussion with Patients

With alarming headlines on the findings suggesting that CAR-T therapy may cause cancer, Rahul Banerjee, MD, and colleagues at the University of Washington, Seattle, recommend the use of “cautious reassurance” in discussing the issue with patients. In a paper published in January in Blood Advances, they suggest a three-part response: underscoring that the benefits of CAR T “far outweigh” the risks in relapsed/refractory malignancies, that the ‘one-and-done’ nature of CAR-T infusions provide meaningful improvements in quality of life, and that the active cancer at hand is “a much larger threat than a hypothetical cancer years later.”

In many cases, patients may only have months to live without CAR-T therapy and will have already had multiple prior lines of therapy, therefore the CAR-T treatment itself may provide time for the secondary primary cancers from any of the treatments to emerge, as experts have noted.

“One has to be alive to be diagnosed with a secondary primary malignancy, and it’s thus very possible that CAR-T may be creating a type of ‘immortal time bias’ wherein patients live long enough to experience the unfortunate sequelae of their previous therapies,” Dr. Banerjee explained in an interview.

Nevertheless, the potential for substantial improvements in quality of life with CAR-T therapy compared with traditional treatments addresses a top priority for patients, he added.

“For most patients with [for instance], myeloma, the ability of CAR-T to put them rapidly into a deep remission without the need for maintenance is an unheard-of potential for them,” Dr. Banerjee said.

“In multiple myeloma, no CAR-T therapy has (yet) demonstrated an overall survival benefit — but I think the substantial quality-of-life benefit stands by itself as a big reason why patients continue to prefer CAR-T.”
 

Keep Patients In Touch with CAR T Centers

In light of the concerns regarding the secondary malignancies, Dr. Banerjee underscored that CAR-T patients should be kept in close touch with centers that have CAR-T treatment expertise.

With most patients followed primarily at community practices where CAR-T therapy is not administered, “I’d strongly encourage my colleagues in community practices to refer all eligible patients to a CAR-T-capable center for evaluation regardless of what their risk of post-CAR-T secondary primary malignancies may be,” Dr. Banerjee urged.

“Based on the evidence we have currently, which includes the FDA’s updated information, there are many more unknowns about this potential secondary primary malignancy risk than knowns,” he said. “This is of course a much more nuanced issue than any one package insert can convey, and CAR-T experts at treating centers can have these conversations at length with eligible patients who are nervous about these recent updates.”

Dr. Ruella disclosed that he holds patents related to CD19 CAR T cells, as well as relationships with NanoString, Bristol Myers Squibb, GlaxoSmithKline, Scailyte, Bayer, AbClon, Oxford NanoImaging, CURIOX, and Beckman Coulter, and he was the scientific founder of viTToria Biotherapeutics. Dr. Banerjee reported ties with BMS, Caribou Biosciences, Genentech, Janssen, Karyopharm, Pfizer, Sanofi, SparkCures, Novartis, and Pack Health.

“New antibiotics discovered using AI!”

That’s how headlines read in December 2023, when MIT researchers announced a new class of antibiotics that could wipe out the drug-resistant superbug methicillin-resistant Staphylococcus aureus (MRSA) in mice.

Powered by deep learning, the study was a significant breakthrough. Few new antibiotics have come out since the 1960s, and this one in particular could be crucial in fighting tough-to-treat MRSA, which kills more than 10,000 people annually in the United States.

But as remarkable as the antibiotic discovery was, it may not be the most impactful part of this study.

The researchers used a method known as explainable artificial intelligence (AI), which unveils the AI’s reasoning process, sometimes known as the black box because it’s hidden from the user. Their work in this emerging field could be pivotal in advancing new drug design.

“Of course, we view the antibiotic-discovery angle to be very important,” said Felix Wong, PhD, a colead author of the study and postdoctoral fellow at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts. “But I think equally important, or maybe even more important, is really our method of opening up the black box.”

The black box is generally thought of as impenetrable in complex machine learning models, and that poses a challenge in the drug discovery realm.

“A major bottleneck in AI-ML-driven drug discovery is that nobody knows what the heck is going on,” said Dr. Wong. Models have such powerful architectures that their decision-making is mysterious.

Researchers input data, such as patient features, and the model says what drugs might be effective. But researchers have no idea how the model arrived at its predictions — until now.

What the Researchers Did

Dr. Wong and his colleagues first mined 39,000 compounds for antibiotic activity against MRSA. They fed information about the compounds’ chemical structures and antibiotic activity into their machine learning model. With this, they “trained” the model to predict whether a compound is antibacterial.

Next, they used additional deep learning to narrow the field, ruling out compounds toxic to humans. Then, deploying their various models at once, they screened 12 million commercially available compounds. Five classes emerged as likely MRSA fighters. Further testing of 280 compounds from the five classes produced the final results: Two compounds from the same class. Both reduced MRSA infection in mouse models.

How did the computer flag these compounds? The researchers sought to answer that question by figuring out which chemical structures the model had been looking for.

A chemical structure can be “pruned” — that is, scientists can remove certain atoms and bonds to reveal an underlying substructure. The MIT researchers used the Monte Carlo Tree Search, a commonly used algorithm in machine learning, to select which atoms and bonds to edit out. Then they fed the pruned substructures into their model to find out which was likely responsible for the antibacterial activity.

“The main idea is we can pinpoint which substructure of a chemical structure is causative instead of just correlated with high antibiotic activity,” Dr. Wong said.

This could fuel new “design-driven” or generative AI approaches where these substructures become “starting points to design entirely unseen, unprecedented antibiotics,” Dr. Wong said. “That’s one of the key efforts that we’ve been working on since the publication of this paper.”

More broadly, their method could lead to discoveries in drug classes beyond antibiotics, such as antivirals and anticancer drugs, according to Dr. Wong.

“This is the first major study that I’ve seen seeking to incorporate explainability into deep learning models in the context of antibiotics,” said César de la Fuente, PhD, an assistant professor at the University of Pennsylvania, Philadelphia, Pennsylvania, whose lab has been engaged in AI for antibiotic discovery for the past 5 years.

“It’s kind of like going into the black box with a magnifying lens and figuring out what is actually happening in there,” Dr. de la Fuente said. “And that will open up possibilities for leveraging those different steps to make better drugs.”

How Explainable AI Could Revolutionize Medicine

In studies, explainable AI is showing its potential for informing clinical decisions as well — flagging high-risk patients and letting doctors know why that calculation was made. University of Washington researchers have used the technology to predict whether a patient will have hypoxemia during surgery, revealing which features contributed to the prediction, such as blood pressure or body mass index. Another study used explainable AI to help emergency medical services providers and emergency room clinicians optimize time — for example, by identifying trauma patients at high risk for acute traumatic coagulopathy more quickly.

A crucial benefit of explainable AI is its ability to audit machine learning models for mistakes, said Su-In Lee, PhD, a computer scientist who led the UW research.

For example, a surge of research during the pandemic suggested that AI models could predict COVID-19 infection based on chest x-rays. Dr. Lee’s research used explainable AI to show that many of the studies were not as accurate as they claimed. Her lab revealed that many models› decisions were based not on pathologies but rather on other aspects such as laterality markers in the corners of x-rays or medical devices worn by patients (like pacemakers). She applied the same model auditing technique to AI-powered dermatology devices, digging into the flawed reasoning in their melanoma predictions. 

Explainable AI is beginning to affect drug development too. A 2023 study led by Dr. Lee used it to explain how to select complementary drugs for acute myeloid leukemia patients based on the differentiation levels of cancer cells. And in two other studies aimed at identifying Alzheimer’s therapeutic targets, “explainable AI played a key role in terms of identifying the driver pathway,” she said.

Currently, the US Food and Drug Administration (FDA) approval doesn’t require an understanding of a drug’s mechanism of action. But the issue is being raised more often, including at December’s Health Regulatory Policy Conference at MIT’s Jameel Clinic. And just over a year ago, Dr. Lee predicted that the FDA approval process would come to incorporate explainable AI analysis.

“I didn’t hesitate,” Dr. Lee said, regarding her prediction. “We didn’t see this in 2023, so I won’t assert that I was right, but I can confidently say that we are progressing in that direction.”

What’s Next?

The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.

Even with the AI’s assistance, there’s still a long way to go before clinical approval.

But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Dr. Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.

A version of this article appeared on Medscape.com.

“New antibiotics discovered using AI!”

That’s how headlines read in December 2023, when MIT researchers announced a new class of antibiotics that could wipe out the drug-resistant superbug methicillin-resistant Staphylococcus aureus (MRSA) in mice.

Powered by deep learning, the study was a significant breakthrough. Few new antibiotics have come out since the 1960s, and this one in particular could be crucial in fighting tough-to-treat MRSA, which kills more than 10,000 people annually in the United States.

But as remarkable as the antibiotic discovery was, it may not be the most impactful part of this study.

The researchers used a method known as explainable artificial intelligence (AI), which unveils the AI’s reasoning process, sometimes known as the black box because it’s hidden from the user. Their work in this emerging field could be pivotal in advancing new drug design.

“Of course, we view the antibiotic-discovery angle to be very important,” said Felix Wong, PhD, a colead author of the study and postdoctoral fellow at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts. “But I think equally important, or maybe even more important, is really our method of opening up the black box.”

The black box is generally thought of as impenetrable in complex machine learning models, and that poses a challenge in the drug discovery realm.

“A major bottleneck in AI-ML-driven drug discovery is that nobody knows what the heck is going on,” said Dr. Wong. Models have such powerful architectures that their decision-making is mysterious.

Researchers input data, such as patient features, and the model says what drugs might be effective. But researchers have no idea how the model arrived at its predictions — until now.

What the Researchers Did

Dr. Wong and his colleagues first mined 39,000 compounds for antibiotic activity against MRSA. They fed information about the compounds’ chemical structures and antibiotic activity into their machine learning model. With this, they “trained” the model to predict whether a compound is antibacterial.

Next, they used additional deep learning to narrow the field, ruling out compounds toxic to humans. Then, deploying their various models at once, they screened 12 million commercially available compounds. Five classes emerged as likely MRSA fighters. Further testing of 280 compounds from the five classes produced the final results: Two compounds from the same class. Both reduced MRSA infection in mouse models.

How did the computer flag these compounds? The researchers sought to answer that question by figuring out which chemical structures the model had been looking for.

A chemical structure can be “pruned” — that is, scientists can remove certain atoms and bonds to reveal an underlying substructure. The MIT researchers used the Monte Carlo Tree Search, a commonly used algorithm in machine learning, to select which atoms and bonds to edit out. Then they fed the pruned substructures into their model to find out which was likely responsible for the antibacterial activity.

“The main idea is we can pinpoint which substructure of a chemical structure is causative instead of just correlated with high antibiotic activity,” Dr. Wong said.

This could fuel new “design-driven” or generative AI approaches where these substructures become “starting points to design entirely unseen, unprecedented antibiotics,” Dr. Wong said. “That’s one of the key efforts that we’ve been working on since the publication of this paper.”

More broadly, their method could lead to discoveries in drug classes beyond antibiotics, such as antivirals and anticancer drugs, according to Dr. Wong.

“This is the first major study that I’ve seen seeking to incorporate explainability into deep learning models in the context of antibiotics,” said César de la Fuente, PhD, an assistant professor at the University of Pennsylvania, Philadelphia, Pennsylvania, whose lab has been engaged in AI for antibiotic discovery for the past 5 years.

“It’s kind of like going into the black box with a magnifying lens and figuring out what is actually happening in there,” Dr. de la Fuente said. “And that will open up possibilities for leveraging those different steps to make better drugs.”

How Explainable AI Could Revolutionize Medicine

In studies, explainable AI is showing its potential for informing clinical decisions as well — flagging high-risk patients and letting doctors know why that calculation was made. University of Washington researchers have used the technology to predict whether a patient will have hypoxemia during surgery, revealing which features contributed to the prediction, such as blood pressure or body mass index. Another study used explainable AI to help emergency medical services providers and emergency room clinicians optimize time — for example, by identifying trauma patients at high risk for acute traumatic coagulopathy more quickly.

A crucial benefit of explainable AI is its ability to audit machine learning models for mistakes, said Su-In Lee, PhD, a computer scientist who led the UW research.

For example, a surge of research during the pandemic suggested that AI models could predict COVID-19 infection based on chest x-rays. Dr. Lee’s research used explainable AI to show that many of the studies were not as accurate as they claimed. Her lab revealed that many models› decisions were based not on pathologies but rather on other aspects such as laterality markers in the corners of x-rays or medical devices worn by patients (like pacemakers). She applied the same model auditing technique to AI-powered dermatology devices, digging into the flawed reasoning in their melanoma predictions. 

Explainable AI is beginning to affect drug development too. A 2023 study led by Dr. Lee used it to explain how to select complementary drugs for acute myeloid leukemia patients based on the differentiation levels of cancer cells. And in two other studies aimed at identifying Alzheimer’s therapeutic targets, “explainable AI played a key role in terms of identifying the driver pathway,” she said.

Currently, the US Food and Drug Administration (FDA) approval doesn’t require an understanding of a drug’s mechanism of action. But the issue is being raised more often, including at December’s Health Regulatory Policy Conference at MIT’s Jameel Clinic. And just over a year ago, Dr. Lee predicted that the FDA approval process would come to incorporate explainable AI analysis.

“I didn’t hesitate,” Dr. Lee said, regarding her prediction. “We didn’t see this in 2023, so I won’t assert that I was right, but I can confidently say that we are progressing in that direction.”

What’s Next?

The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.

Even with the AI’s assistance, there’s still a long way to go before clinical approval.

But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Dr. Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.

A version of this article appeared on Medscape.com.

“New antibiotics discovered using AI!”

That’s how headlines read in December 2023, when MIT researchers announced a new class of antibiotics that could wipe out the drug-resistant superbug methicillin-resistant Staphylococcus aureus (MRSA) in mice.

Powered by deep learning, the study was a significant breakthrough. Few new antibiotics have come out since the 1960s, and this one in particular could be crucial in fighting tough-to-treat MRSA, which kills more than 10,000 people annually in the United States.

But as remarkable as the antibiotic discovery was, it may not be the most impactful part of this study.

The researchers used a method known as explainable artificial intelligence (AI), which unveils the AI’s reasoning process, sometimes known as the black box because it’s hidden from the user. Their work in this emerging field could be pivotal in advancing new drug design.

“Of course, we view the antibiotic-discovery angle to be very important,” said Felix Wong, PhD, a colead author of the study and postdoctoral fellow at the Broad Institute of MIT and Harvard, Cambridge, Massachusetts. “But I think equally important, or maybe even more important, is really our method of opening up the black box.”

The black box is generally thought of as impenetrable in complex machine learning models, and that poses a challenge in the drug discovery realm.

“A major bottleneck in AI-ML-driven drug discovery is that nobody knows what the heck is going on,” said Dr. Wong. Models have such powerful architectures that their decision-making is mysterious.

Researchers input data, such as patient features, and the model says what drugs might be effective. But researchers have no idea how the model arrived at its predictions — until now.

What the Researchers Did

Dr. Wong and his colleagues first mined 39,000 compounds for antibiotic activity against MRSA. They fed information about the compounds’ chemical structures and antibiotic activity into their machine learning model. With this, they “trained” the model to predict whether a compound is antibacterial.

Next, they used additional deep learning to narrow the field, ruling out compounds toxic to humans. Then, deploying their various models at once, they screened 12 million commercially available compounds. Five classes emerged as likely MRSA fighters. Further testing of 280 compounds from the five classes produced the final results: Two compounds from the same class. Both reduced MRSA infection in mouse models.

How did the computer flag these compounds? The researchers sought to answer that question by figuring out which chemical structures the model had been looking for.

A chemical structure can be “pruned” — that is, scientists can remove certain atoms and bonds to reveal an underlying substructure. The MIT researchers used the Monte Carlo Tree Search, a commonly used algorithm in machine learning, to select which atoms and bonds to edit out. Then they fed the pruned substructures into their model to find out which was likely responsible for the antibacterial activity.

“The main idea is we can pinpoint which substructure of a chemical structure is causative instead of just correlated with high antibiotic activity,” Dr. Wong said.

This could fuel new “design-driven” or generative AI approaches where these substructures become “starting points to design entirely unseen, unprecedented antibiotics,” Dr. Wong said. “That’s one of the key efforts that we’ve been working on since the publication of this paper.”

More broadly, their method could lead to discoveries in drug classes beyond antibiotics, such as antivirals and anticancer drugs, according to Dr. Wong.

“This is the first major study that I’ve seen seeking to incorporate explainability into deep learning models in the context of antibiotics,” said César de la Fuente, PhD, an assistant professor at the University of Pennsylvania, Philadelphia, Pennsylvania, whose lab has been engaged in AI for antibiotic discovery for the past 5 years.

“It’s kind of like going into the black box with a magnifying lens and figuring out what is actually happening in there,” Dr. de la Fuente said. “And that will open up possibilities for leveraging those different steps to make better drugs.”

How Explainable AI Could Revolutionize Medicine

In studies, explainable AI is showing its potential for informing clinical decisions as well — flagging high-risk patients and letting doctors know why that calculation was made. University of Washington researchers have used the technology to predict whether a patient will have hypoxemia during surgery, revealing which features contributed to the prediction, such as blood pressure or body mass index. Another study used explainable AI to help emergency medical services providers and emergency room clinicians optimize time — for example, by identifying trauma patients at high risk for acute traumatic coagulopathy more quickly.

A crucial benefit of explainable AI is its ability to audit machine learning models for mistakes, said Su-In Lee, PhD, a computer scientist who led the UW research.

For example, a surge of research during the pandemic suggested that AI models could predict COVID-19 infection based on chest x-rays. Dr. Lee’s research used explainable AI to show that many of the studies were not as accurate as they claimed. Her lab revealed that many models› decisions were based not on pathologies but rather on other aspects such as laterality markers in the corners of x-rays or medical devices worn by patients (like pacemakers). She applied the same model auditing technique to AI-powered dermatology devices, digging into the flawed reasoning in their melanoma predictions. 

Explainable AI is beginning to affect drug development too. A 2023 study led by Dr. Lee used it to explain how to select complementary drugs for acute myeloid leukemia patients based on the differentiation levels of cancer cells. And in two other studies aimed at identifying Alzheimer’s therapeutic targets, “explainable AI played a key role in terms of identifying the driver pathway,” she said.

Currently, the US Food and Drug Administration (FDA) approval doesn’t require an understanding of a drug’s mechanism of action. But the issue is being raised more often, including at December’s Health Regulatory Policy Conference at MIT’s Jameel Clinic. And just over a year ago, Dr. Lee predicted that the FDA approval process would come to incorporate explainable AI analysis.

“I didn’t hesitate,” Dr. Lee said, regarding her prediction. “We didn’t see this in 2023, so I won’t assert that I was right, but I can confidently say that we are progressing in that direction.”

What’s Next?

The MIT study is part of the Antibiotics-AI project, a 7-year effort to leverage AI to find new antibiotics. Phare Bio, a nonprofit started by MIT professor James Collins, PhD, and others, will do clinical testing on the antibiotic candidates.

Even with the AI’s assistance, there’s still a long way to go before clinical approval.

But knowing which elements contribute to a candidate’s effectiveness against MRSA could help the researchers formulate scientific hypotheses and design better validation, Dr. Lee noted. In other words, because they used explainable AI, they could be better positioned for clinical trial success.

A version of this article appeared on Medscape.com.

Picture your marriage proposal fantasy. Do you see a beautiful beach at sunset? The place where you first met your partner? Maybe a dream vacation — Paris, anyone? And perhaps most popular of all ... the ER?

Why not? For some couples who share medical careers, the hospital is home, and they turn the moment into something just as romantic as any Eiffel Tower backdrop. (And admittedly, sometimes they don’t.)

Since we’re approaching Valentine’s Day— often the #1 day of the year for engagements — lovestruck healthcare professionals take note. There are good ways to do it and, well, ill-advised ways. We spoke with three couples whose medical-themed proposals ended in the word “yes!” 

Heaven on the Helipad

When emergency medicine physician Anna Darby, MD, heard a trauma patient was arriving and urgently needed to be intubated, she raced up to the rooftop helipad. As soon as the elevator doors opened, she was met with quite a different scene than expected. There were rose petals ... lots and lots of rose petals.

With her best friends and colleagues lining a red carpet, the roof had been turned into a scene from The Bachelor. Each person gave her a rose. A friend even touched up her makeup and handed over her favorite hoop earrings, transforming her from busy doctor to soon-to-be fiancée. Her boyfriend, cardiologist Merije Chukumerije, MD, stood waiting. You can guess what happened next.

Dr. Chukumerije later wrote in an Instagram post, “We met at this hospital. So, it was only right that I bring her to its highest place as we’ve reached the peak of our union.” The couple actually met in the hospital cafeteria “like all the clichés,” Dr. Darby jokes. For them, the helipad experience was just as Insta-worthy as any braggable, grandiose proposal at a fancy restaurant or on a mountaintop.

“Seeing that scene was totally not what I expected,” Dr. Darby says. “I can’t even describe it. It’s like the second biggest hormonal shift, [second only to] having a baby.” She and Dr. Chukumerije now have two babies of their own, aged 2 months and 2 years old.

Good Morning, Doctor

It was February 2021, the height of the pandemic, and Raaga Vemula, MD, now in her palliative care/hospice care fellowship, was “selected” for a local news interview on COVID-19. Except the interview was really with Good Morning America. And the topic was really a proposal. 

Dr. Vemula met Steven Bean, MD, now doing a sleep medicine fellowship, in 2015. “I first saw her, and thought she was one of the prettiest women I’d ever seen. ... We ended up being in the same study group,” he says. “Let’s be honest, I applied to every med school she applied to.” 

Six years later, Dr. Bean connected with GMA through The Knot, a wedding planning website and registry. The made-up interview request for Dr. Vemula came from the residency program director, who was in on the surprise. Dr. Vemula’s family also knew what was up when she called with the “news.” 

The live broadcast took place at the hospital. Dr. Bean had an earpiece for the producers to give him directions. But “I was so nervous, I walked out immediately,” he says. He ended up standing behind Dr. Vemula. The mistake worked well for viewers though, building anticipation while she answered a COVID-19 question. “We got everybody excited,” says Dr. Bean. “So, when they said ’Raaga, turn around’ it worked out perfectly. She was confused as hell.”

Luckily, Dr. Vemula loves a good surprise. “He knows me very well,” she says. 

For her, the proposal was even more meaningful given their background together. “Medicine means so much to both of us and was such a big part of our lives,” she says. “That’s what shaped us to do this. ... I think in our hearts it was meant to be this way.” 

Who Says Masks Don’t Work?

Masks conjure up feelings for anyone living through the pandemic, especially medical personnel. But for Rhett Franklin and wife Lauren Gray, they will always symbolize of one of the biggest days of their lives.

Mr. Franklin worked in registration, often following Ms. Gray, an emergency room nurse, around with a wheeled computer station to gather patient information (what’s known as a “creeper,” which isn’t as creepy as it sounds). Eventually, she offered to grab a coffee with him, and when he suggested another coffee, she said it was time for him to buy her a drink. 

Mr. Franklin, now a manager of business operations for nursing administration, originally planned to propose to Ms. Gray on a trip to England. But the pandemic prevented their vacation with its potential castle backdrop. 

Mr. Franklin often picked up shifts making masks for frontline workers, and an alternate proposal idea started brewing. He schemed to have two very special masks made. “Mine was a black tuxedo that said, ‘Will you marry me?’ and hers resembled a white dress that said, ‘I said yes!’ ” Mr. Franklin says. 

But a text almost ruined the surprise. When Mr. Franklin messaged family members about his proposal plan the day before, one relative responded in a group chat that included Ms. Gray. This was when the busy ER came to the rescue — no time to read texts. Family members also started calling Ms. Gray on the hospital’s phoneline as a distraction. Unfazed, Mr. Franklin simply moved up the proposal to that night. 

At their favorite dog beach, as the sunset gleamed on the water, Mr. Franklin pulled his mask out and took a knee. He can’t recall what he said behind that mask. “It was kind of one of those blackout moments.” But Ms. Gray remembers for him — “You said ‘Let’s do this.’ ”

Warning Label

Everyone has different tastes. Some healthcare professionals have taken the medical theme further than these couples — maybe too far. A few have even faked life-threatening emergencies, showing up in the ER on a gurney with a made-up peanut allergy reaction or a severe injury and then pulling out a ring.

But who’s to judge? For some, thinking your partner is “dying” and then learning you’ve been tricked might not conjure up the warmest feelings. For others, apparently, it’s a virtual bouquet of roses. 

A Few Proposal Pointers

If you’re planning to pop the question, this group says, “go for the medical setting!” But according to them, there are other must-haves to get that “yes” and the lifetime of wedded bliss, of course:

• Make it a hospital-wide morale-booster. “Everyone loves surprises,” Dr. Bean maintains. So, why not bring your colleagues in on the conspiracy? “Involving coworkers will strengthen relationships with their work family by leaving lasting memories for everyone,” he says. “In a busy medical setting, it’s usually unexpected, so it makes it extra special.” 
• Have a backup plan. As healthcare professionals, you know that schedules get in the way of everything. So, practice that flexibility you will need as a marriage skill. When Mr. Franklin’s first two engagement locations fell though, he says, it was important to adapt and not panic when things went awry.
• Seize the moment. Think you can’t get engaged during residency? “Planning a proposal during intern year of residency is totally manageable,” Dr. Vemula says. “That way as residency progresses and you have more time, there is more time to focus on the wedding planning.” But she cautions that, “wedding planning during the intern year would be quite difficult.”

A version of this article appeared on Medscape.com.

Picture your marriage proposal fantasy. Do you see a beautiful beach at sunset? The place where you first met your partner? Maybe a dream vacation — Paris, anyone? And perhaps most popular of all ... the ER?

Why not? For some couples who share medical careers, the hospital is home, and they turn the moment into something just as romantic as any Eiffel Tower backdrop. (And admittedly, sometimes they don’t.)

Since we’re approaching Valentine’s Day— often the #1 day of the year for engagements — lovestruck healthcare professionals take note. There are good ways to do it and, well, ill-advised ways. We spoke with three couples whose medical-themed proposals ended in the word “yes!” 

Heaven on the Helipad

When emergency medicine physician Anna Darby, MD, heard a trauma patient was arriving and urgently needed to be intubated, she raced up to the rooftop helipad. As soon as the elevator doors opened, she was met with quite a different scene than expected. There were rose petals ... lots and lots of rose petals.

With her best friends and colleagues lining a red carpet, the roof had been turned into a scene from The Bachelor. Each person gave her a rose. A friend even touched up her makeup and handed over her favorite hoop earrings, transforming her from busy doctor to soon-to-be fiancée. Her boyfriend, cardiologist Merije Chukumerije, MD, stood waiting. You can guess what happened next.

Dr. Chukumerije later wrote in an Instagram post, “We met at this hospital. So, it was only right that I bring her to its highest place as we’ve reached the peak of our union.” The couple actually met in the hospital cafeteria “like all the clichés,” Dr. Darby jokes. For them, the helipad experience was just as Insta-worthy as any braggable, grandiose proposal at a fancy restaurant or on a mountaintop.

“Seeing that scene was totally not what I expected,” Dr. Darby says. “I can’t even describe it. It’s like the second biggest hormonal shift, [second only to] having a baby.” She and Dr. Chukumerije now have two babies of their own, aged 2 months and 2 years old.

Good Morning, Doctor

It was February 2021, the height of the pandemic, and Raaga Vemula, MD, now in her palliative care/hospice care fellowship, was “selected” for a local news interview on COVID-19. Except the interview was really with Good Morning America. And the topic was really a proposal. 

Dr. Vemula met Steven Bean, MD, now doing a sleep medicine fellowship, in 2015. “I first saw her, and thought she was one of the prettiest women I’d ever seen. ... We ended up being in the same study group,” he says. “Let’s be honest, I applied to every med school she applied to.” 

Six years later, Dr. Bean connected with GMA through The Knot, a wedding planning website and registry. The made-up interview request for Dr. Vemula came from the residency program director, who was in on the surprise. Dr. Vemula’s family also knew what was up when she called with the “news.” 

The live broadcast took place at the hospital. Dr. Bean had an earpiece for the producers to give him directions. But “I was so nervous, I walked out immediately,” he says. He ended up standing behind Dr. Vemula. The mistake worked well for viewers though, building anticipation while she answered a COVID-19 question. “We got everybody excited,” says Dr. Bean. “So, when they said ’Raaga, turn around’ it worked out perfectly. She was confused as hell.”

Luckily, Dr. Vemula loves a good surprise. “He knows me very well,” she says. 

For her, the proposal was even more meaningful given their background together. “Medicine means so much to both of us and was such a big part of our lives,” she says. “That’s what shaped us to do this. ... I think in our hearts it was meant to be this way.” 

Who Says Masks Don’t Work?

Masks conjure up feelings for anyone living through the pandemic, especially medical personnel. But for Rhett Franklin and wife Lauren Gray, they will always symbolize of one of the biggest days of their lives.

Mr. Franklin worked in registration, often following Ms. Gray, an emergency room nurse, around with a wheeled computer station to gather patient information (what’s known as a “creeper,” which isn’t as creepy as it sounds). Eventually, she offered to grab a coffee with him, and when he suggested another coffee, she said it was time for him to buy her a drink. 

Mr. Franklin, now a manager of business operations for nursing administration, originally planned to propose to Ms. Gray on a trip to England. But the pandemic prevented their vacation with its potential castle backdrop. 

Mr. Franklin often picked up shifts making masks for frontline workers, and an alternate proposal idea started brewing. He schemed to have two very special masks made. “Mine was a black tuxedo that said, ‘Will you marry me?’ and hers resembled a white dress that said, ‘I said yes!’ ” Mr. Franklin says. 

But a text almost ruined the surprise. When Mr. Franklin messaged family members about his proposal plan the day before, one relative responded in a group chat that included Ms. Gray. This was when the busy ER came to the rescue — no time to read texts. Family members also started calling Ms. Gray on the hospital’s phoneline as a distraction. Unfazed, Mr. Franklin simply moved up the proposal to that night. 

At their favorite dog beach, as the sunset gleamed on the water, Mr. Franklin pulled his mask out and took a knee. He can’t recall what he said behind that mask. “It was kind of one of those blackout moments.” But Ms. Gray remembers for him — “You said ‘Let’s do this.’ ”

Warning Label

Everyone has different tastes. Some healthcare professionals have taken the medical theme further than these couples — maybe too far. A few have even faked life-threatening emergencies, showing up in the ER on a gurney with a made-up peanut allergy reaction or a severe injury and then pulling out a ring.

But who’s to judge? For some, thinking your partner is “dying” and then learning you’ve been tricked might not conjure up the warmest feelings. For others, apparently, it’s a virtual bouquet of roses. 

A Few Proposal Pointers

If you’re planning to pop the question, this group says, “go for the medical setting!” But according to them, there are other must-haves to get that “yes” and the lifetime of wedded bliss, of course:

• Make it a hospital-wide morale-booster. “Everyone loves surprises,” Dr. Bean maintains. So, why not bring your colleagues in on the conspiracy? “Involving coworkers will strengthen relationships with their work family by leaving lasting memories for everyone,” he says. “In a busy medical setting, it’s usually unexpected, so it makes it extra special.” 
• Have a backup plan. As healthcare professionals, you know that schedules get in the way of everything. So, practice that flexibility you will need as a marriage skill. When Mr. Franklin’s first two engagement locations fell though, he says, it was important to adapt and not panic when things went awry.
• Seize the moment. Think you can’t get engaged during residency? “Planning a proposal during intern year of residency is totally manageable,” Dr. Vemula says. “That way as residency progresses and you have more time, there is more time to focus on the wedding planning.” But she cautions that, “wedding planning during the intern year would be quite difficult.”

A version of this article appeared on Medscape.com.

Picture your marriage proposal fantasy. Do you see a beautiful beach at sunset? The place where you first met your partner? Maybe a dream vacation — Paris, anyone? And perhaps most popular of all ... the ER?

Why not? For some couples who share medical careers, the hospital is home, and they turn the moment into something just as romantic as any Eiffel Tower backdrop. (And admittedly, sometimes they don’t.)

Since we’re approaching Valentine’s Day— often the #1 day of the year for engagements — lovestruck healthcare professionals take note. There are good ways to do it and, well, ill-advised ways. We spoke with three couples whose medical-themed proposals ended in the word “yes!” 

Heaven on the Helipad

When emergency medicine physician Anna Darby, MD, heard a trauma patient was arriving and urgently needed to be intubated, she raced up to the rooftop helipad. As soon as the elevator doors opened, she was met with quite a different scene than expected. There were rose petals ... lots and lots of rose petals.

With her best friends and colleagues lining a red carpet, the roof had been turned into a scene from The Bachelor. Each person gave her a rose. A friend even touched up her makeup and handed over her favorite hoop earrings, transforming her from busy doctor to soon-to-be fiancée. Her boyfriend, cardiologist Merije Chukumerije, MD, stood waiting. You can guess what happened next.

Dr. Chukumerije later wrote in an Instagram post, “We met at this hospital. So, it was only right that I bring her to its highest place as we’ve reached the peak of our union.” The couple actually met in the hospital cafeteria “like all the clichés,” Dr. Darby jokes. For them, the helipad experience was just as Insta-worthy as any braggable, grandiose proposal at a fancy restaurant or on a mountaintop.

“Seeing that scene was totally not what I expected,” Dr. Darby says. “I can’t even describe it. It’s like the second biggest hormonal shift, [second only to] having a baby.” She and Dr. Chukumerije now have two babies of their own, aged 2 months and 2 years old.

Good Morning, Doctor

It was February 2021, the height of the pandemic, and Raaga Vemula, MD, now in her palliative care/hospice care fellowship, was “selected” for a local news interview on COVID-19. Except the interview was really with Good Morning America. And the topic was really a proposal. 

Dr. Vemula met Steven Bean, MD, now doing a sleep medicine fellowship, in 2015. “I first saw her, and thought she was one of the prettiest women I’d ever seen. ... We ended up being in the same study group,” he says. “Let’s be honest, I applied to every med school she applied to.” 

Six years later, Dr. Bean connected with GMA through The Knot, a wedding planning website and registry. The made-up interview request for Dr. Vemula came from the residency program director, who was in on the surprise. Dr. Vemula’s family also knew what was up when she called with the “news.” 

The live broadcast took place at the hospital. Dr. Bean had an earpiece for the producers to give him directions. But “I was so nervous, I walked out immediately,” he says. He ended up standing behind Dr. Vemula. The mistake worked well for viewers though, building anticipation while she answered a COVID-19 question. “We got everybody excited,” says Dr. Bean. “So, when they said ’Raaga, turn around’ it worked out perfectly. She was confused as hell.”

Luckily, Dr. Vemula loves a good surprise. “He knows me very well,” she says. 

For her, the proposal was even more meaningful given their background together. “Medicine means so much to both of us and was such a big part of our lives,” she says. “That’s what shaped us to do this. ... I think in our hearts it was meant to be this way.” 

Who Says Masks Don’t Work?

Masks conjure up feelings for anyone living through the pandemic, especially medical personnel. But for Rhett Franklin and wife Lauren Gray, they will always symbolize of one of the biggest days of their lives.

Mr. Franklin worked in registration, often following Ms. Gray, an emergency room nurse, around with a wheeled computer station to gather patient information (what’s known as a “creeper,” which isn’t as creepy as it sounds). Eventually, she offered to grab a coffee with him, and when he suggested another coffee, she said it was time for him to buy her a drink. 

Mr. Franklin, now a manager of business operations for nursing administration, originally planned to propose to Ms. Gray on a trip to England. But the pandemic prevented their vacation with its potential castle backdrop. 

Mr. Franklin often picked up shifts making masks for frontline workers, and an alternate proposal idea started brewing. He schemed to have two very special masks made. “Mine was a black tuxedo that said, ‘Will you marry me?’ and hers resembled a white dress that said, ‘I said yes!’ ” Mr. Franklin says. 

But a text almost ruined the surprise. When Mr. Franklin messaged family members about his proposal plan the day before, one relative responded in a group chat that included Ms. Gray. This was when the busy ER came to the rescue — no time to read texts. Family members also started calling Ms. Gray on the hospital’s phoneline as a distraction. Unfazed, Mr. Franklin simply moved up the proposal to that night. 

At their favorite dog beach, as the sunset gleamed on the water, Mr. Franklin pulled his mask out and took a knee. He can’t recall what he said behind that mask. “It was kind of one of those blackout moments.” But Ms. Gray remembers for him — “You said ‘Let’s do this.’ ”

Warning Label

Everyone has different tastes. Some healthcare professionals have taken the medical theme further than these couples — maybe too far. A few have even faked life-threatening emergencies, showing up in the ER on a gurney with a made-up peanut allergy reaction or a severe injury and then pulling out a ring.

But who’s to judge? For some, thinking your partner is “dying” and then learning you’ve been tricked might not conjure up the warmest feelings. For others, apparently, it’s a virtual bouquet of roses. 

A Few Proposal Pointers

If you’re planning to pop the question, this group says, “go for the medical setting!” But according to them, there are other must-haves to get that “yes” and the lifetime of wedded bliss, of course:

• Make it a hospital-wide morale-booster. “Everyone loves surprises,” Dr. Bean maintains. So, why not bring your colleagues in on the conspiracy? “Involving coworkers will strengthen relationships with their work family by leaving lasting memories for everyone,” he says. “In a busy medical setting, it’s usually unexpected, so it makes it extra special.” 
• Have a backup plan. As healthcare professionals, you know that schedules get in the way of everything. So, practice that flexibility you will need as a marriage skill. When Mr. Franklin’s first two engagement locations fell though, he says, it was important to adapt and not panic when things went awry.
• Seize the moment. Think you can’t get engaged during residency? “Planning a proposal during intern year of residency is totally manageable,” Dr. Vemula says. “That way as residency progresses and you have more time, there is more time to focus on the wedding planning.” But she cautions that, “wedding planning during the intern year would be quite difficult.”

A version of this article appeared on Medscape.com.

TOPLINE:

A universal cardiovascular disease (CVD) prediction tool performs well in patients with and without atherosclerotic CVD (ASCVD), a new study showed, suggesting this model could facilitate transition from primary to secondary prevention by streamlining risk classification.

METHODOLOGY:

• Researchers used different models to evaluate whether established CVD predictors, including age, sex, race, diabetes, systolic blood pressure, or smoking, are associated with major adverse cardiovascular events (MACEs), including myocardial infarction (MI), stroke, and heart failure (HF), among 9138 patients, mean age 63.8 years, in the Atherosclerosis Risk in Communities (ARIC) study.
• Of these, 609 had ASCVD (history of MI, ischemic stroke, or symptomatic peripheral artery disease) and 8529 did not.
• They extended their exploration to other predictors available in clinical practice, including family history of premature ASCVD, high-sensitivity C-reactive protein, lipoprotein(a), triglycerides, and apolipoprotein B, as well as predictors of HF such as body mass index and heart rate and blood-based cardiac biomarkers.
• An external validation analysis included 5322 participants in the Multi-Ethnic Study of Atherosclerosis (MESA).
• Over a median follow-up of 18.9 years, 3209 ARIC participants (35%) developed MACE for an incidence rate per 1000 person-years of 21.3 for MACE, 12.6 for MI/stroke, and 13.8 for HF.

TAKEAWAY:

• Of all candidate predictors, 10 variables (including established predictors and cardiac biomarkers) were included in the universal prediction model, which demonstrated good calibration in both those with ASCVD (hazard ratio [HR] C-statistic, 0.692; 95% CI, 0.650-0.735) and without ASCVD (HR C-statistic, 0.748; 95% CI, 0.726-0.770).
• As anticipated, the risk for MACE was generally lower in those with no prior ASCVD, but the 5-year risk in the highest quintile of predicted risk in those without ASCVD was higher than that in the lowest two quintiles of the ASCVD group.
• The universal risk prediction model was validated in the MESA community–based cohort; over a median follow-up of 13.7 years, 12% of participants with and without prior ASCVD developed MACE for an incidence rate per 1000 person-years of 10.2 for MACE, 7.4 for MI/stroke, and 4.3 for HF.
• The results were generally similar when examining individual outcomes (MI/stroke and HF) and for both no ASCVD and ASCVD groups across demographic subgroups by age, sex, and race.

IN PRACTICE:

The findings “support the importance of established predictors for classifying long-term CVD risk in both primary and secondary prevention settings,” the authors wrote, adding an advantage to this risk prediction approach could be to help providers and patients “further personalize secondary prevention.”

In an accompanying editorial, Pier Sergio Saba, MD, PhD, Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy, and others said the universal risk assessment approach “is conceptually promising” but noted patients with ASCVD represented only 7% of the study population, and this population was relatively young, potentially limiting the applicability of this risk model in older individuals. Before the risk model can be used in clinical settings, results need to be validated and given incorporation of cardiac biomarkers, “careful cost-benefit analyses may also be needed,” the editorial writers added.

SOURCE:

The study was conducted by Yejin Mok, PHD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. It was published online on January 29, 2024, in the Journal of the American College of Cardiology (JACC).

LIMITATIONS:

The somewhat limited number of study participants with prior ASCVD precluded researchers from quantifying the prognostic impact of ASCVD subtypes (eg, history of MI vs stroke vs peripheral artery disease). The study didn’t have data on some predictors recognized in guidelines (eg, coronary artery calcium and left ventricular ejection fraction). The ARIC analysis included only Black and White participants, and although models were validated in MESA, which included Chinese and Hispanic adults, extrapolation of results to more racially/ethnically diverse populations should be done with care.

DISCLOSURES:

The ARIC study received funding from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and Department of Health and Human Services. The MESA study was supported by the NHLBI and National Center for Advancing Translational Sciences. The study authors and editorial writers had no relevant conflicts of interest.

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

TOPLINE:

A universal cardiovascular disease (CVD) prediction tool performs well in patients with and without atherosclerotic CVD (ASCVD), a new study showed, suggesting this model could facilitate transition from primary to secondary prevention by streamlining risk classification.

METHODOLOGY:

• Researchers used different models to evaluate whether established CVD predictors, including age, sex, race, diabetes, systolic blood pressure, or smoking, are associated with major adverse cardiovascular events (MACEs), including myocardial infarction (MI), stroke, and heart failure (HF), among 9138 patients, mean age 63.8 years, in the Atherosclerosis Risk in Communities (ARIC) study.
• Of these, 609 had ASCVD (history of MI, ischemic stroke, or symptomatic peripheral artery disease) and 8529 did not.
• They extended their exploration to other predictors available in clinical practice, including family history of premature ASCVD, high-sensitivity C-reactive protein, lipoprotein(a), triglycerides, and apolipoprotein B, as well as predictors of HF such as body mass index and heart rate and blood-based cardiac biomarkers.
• An external validation analysis included 5322 participants in the Multi-Ethnic Study of Atherosclerosis (MESA).
• Over a median follow-up of 18.9 years, 3209 ARIC participants (35%) developed MACE for an incidence rate per 1000 person-years of 21.3 for MACE, 12.6 for MI/stroke, and 13.8 for HF.

TAKEAWAY:

• Of all candidate predictors, 10 variables (including established predictors and cardiac biomarkers) were included in the universal prediction model, which demonstrated good calibration in both those with ASCVD (hazard ratio [HR] C-statistic, 0.692; 95% CI, 0.650-0.735) and without ASCVD (HR C-statistic, 0.748; 95% CI, 0.726-0.770).
• As anticipated, the risk for MACE was generally lower in those with no prior ASCVD, but the 5-year risk in the highest quintile of predicted risk in those without ASCVD was higher than that in the lowest two quintiles of the ASCVD group.
• The universal risk prediction model was validated in the MESA community–based cohort; over a median follow-up of 13.7 years, 12% of participants with and without prior ASCVD developed MACE for an incidence rate per 1000 person-years of 10.2 for MACE, 7.4 for MI/stroke, and 4.3 for HF.
• The results were generally similar when examining individual outcomes (MI/stroke and HF) and for both no ASCVD and ASCVD groups across demographic subgroups by age, sex, and race.

IN PRACTICE:

The findings “support the importance of established predictors for classifying long-term CVD risk in both primary and secondary prevention settings,” the authors wrote, adding an advantage to this risk prediction approach could be to help providers and patients “further personalize secondary prevention.”

In an accompanying editorial, Pier Sergio Saba, MD, PhD, Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy, and others said the universal risk assessment approach “is conceptually promising” but noted patients with ASCVD represented only 7% of the study population, and this population was relatively young, potentially limiting the applicability of this risk model in older individuals. Before the risk model can be used in clinical settings, results need to be validated and given incorporation of cardiac biomarkers, “careful cost-benefit analyses may also be needed,” the editorial writers added.

SOURCE:

The study was conducted by Yejin Mok, PHD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. It was published online on January 29, 2024, in the Journal of the American College of Cardiology (JACC).

LIMITATIONS:

The somewhat limited number of study participants with prior ASCVD precluded researchers from quantifying the prognostic impact of ASCVD subtypes (eg, history of MI vs stroke vs peripheral artery disease). The study didn’t have data on some predictors recognized in guidelines (eg, coronary artery calcium and left ventricular ejection fraction). The ARIC analysis included only Black and White participants, and although models were validated in MESA, which included Chinese and Hispanic adults, extrapolation of results to more racially/ethnically diverse populations should be done with care.

DISCLOSURES:

The ARIC study received funding from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and Department of Health and Human Services. The MESA study was supported by the NHLBI and National Center for Advancing Translational Sciences. The study authors and editorial writers had no relevant conflicts of interest.

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

TOPLINE:

A universal cardiovascular disease (CVD) prediction tool performs well in patients with and without atherosclerotic CVD (ASCVD), a new study showed, suggesting this model could facilitate transition from primary to secondary prevention by streamlining risk classification.

METHODOLOGY:

• Researchers used different models to evaluate whether established CVD predictors, including age, sex, race, diabetes, systolic blood pressure, or smoking, are associated with major adverse cardiovascular events (MACEs), including myocardial infarction (MI), stroke, and heart failure (HF), among 9138 patients, mean age 63.8 years, in the Atherosclerosis Risk in Communities (ARIC) study.
• Of these, 609 had ASCVD (history of MI, ischemic stroke, or symptomatic peripheral artery disease) and 8529 did not.
• They extended their exploration to other predictors available in clinical practice, including family history of premature ASCVD, high-sensitivity C-reactive protein, lipoprotein(a), triglycerides, and apolipoprotein B, as well as predictors of HF such as body mass index and heart rate and blood-based cardiac biomarkers.
• An external validation analysis included 5322 participants in the Multi-Ethnic Study of Atherosclerosis (MESA).
• Over a median follow-up of 18.9 years, 3209 ARIC participants (35%) developed MACE for an incidence rate per 1000 person-years of 21.3 for MACE, 12.6 for MI/stroke, and 13.8 for HF.

TAKEAWAY:

• Of all candidate predictors, 10 variables (including established predictors and cardiac biomarkers) were included in the universal prediction model, which demonstrated good calibration in both those with ASCVD (hazard ratio [HR] C-statistic, 0.692; 95% CI, 0.650-0.735) and without ASCVD (HR C-statistic, 0.748; 95% CI, 0.726-0.770).
• As anticipated, the risk for MACE was generally lower in those with no prior ASCVD, but the 5-year risk in the highest quintile of predicted risk in those without ASCVD was higher than that in the lowest two quintiles of the ASCVD group.
• The universal risk prediction model was validated in the MESA community–based cohort; over a median follow-up of 13.7 years, 12% of participants with and without prior ASCVD developed MACE for an incidence rate per 1000 person-years of 10.2 for MACE, 7.4 for MI/stroke, and 4.3 for HF.
• The results were generally similar when examining individual outcomes (MI/stroke and HF) and for both no ASCVD and ASCVD groups across demographic subgroups by age, sex, and race.

IN PRACTICE:

The findings “support the importance of established predictors for classifying long-term CVD risk in both primary and secondary prevention settings,” the authors wrote, adding an advantage to this risk prediction approach could be to help providers and patients “further personalize secondary prevention.”

In an accompanying editorial, Pier Sergio Saba, MD, PhD, Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy, and others said the universal risk assessment approach “is conceptually promising” but noted patients with ASCVD represented only 7% of the study population, and this population was relatively young, potentially limiting the applicability of this risk model in older individuals. Before the risk model can be used in clinical settings, results need to be validated and given incorporation of cardiac biomarkers, “careful cost-benefit analyses may also be needed,” the editorial writers added.

SOURCE:

The study was conducted by Yejin Mok, PHD, MPH, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. It was published online on January 29, 2024, in the Journal of the American College of Cardiology (JACC).

LIMITATIONS:

The somewhat limited number of study participants with prior ASCVD precluded researchers from quantifying the prognostic impact of ASCVD subtypes (eg, history of MI vs stroke vs peripheral artery disease). The study didn’t have data on some predictors recognized in guidelines (eg, coronary artery calcium and left ventricular ejection fraction). The ARIC analysis included only Black and White participants, and although models were validated in MESA, which included Chinese and Hispanic adults, extrapolation of results to more racially/ethnically diverse populations should be done with care.

DISCLOSURES:

The ARIC study received funding from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and Department of Health and Human Services. The MESA study was supported by the NHLBI and National Center for Advancing Translational Sciences. The study authors and editorial writers had no relevant conflicts of interest.

A version of this article first 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. 

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

TOPLINE:

Allergens were present in more than half of evaluable over-the-counter (OTC) topical scar products, study finds. 

METHODOLOGY:

• OTC topical scar treatments have the potential to cause an allergic reaction, but the prevalence of North American Contact Dermatitis Group (NACDG) core allergens in these products is unclear.
• Researchers used the word scar in a query of Amazon.com and four other retail websites to identify topical scar products for consumers and noted the list of ingredients.
• The investigators also surveyed the American Contact Dermatitis Society’s Contact Allergen Management Program (CAMP), a resource that helps patients with allergies find personal care products that are safe to use, for pertinent products.

TAKEAWAY: 

• The search query identified 156 products. Of these, 119 (76.2%) were gels, creams, or oils and 37 (23.7%) were sheets, strips, or tape.
• Of the 125 products that had a list of ingredients, 69 (55.2%) contained at least one NACDG allergen and 45 (36%) contained more than one.
• The top six most common allergens listed in the ingredients were fragrance (16.8%), phenoxyethanol (16.8%), parabens (14.4%), panthenol (12.8%), sodium benzoate (9.60%), and ethylhexylglycerin (8%).
• Analysis of CAMP revealed that the program only had five unique scar products in its list, suggesting that CAMP might not be a reliable source of scar product information for patients with known allergies to pertinent NACDG allergens.

IN PRACTICE:

“Patients can consider trying a ‘use test’ on the inner forearm before applying to the surgical site,” the authors wrote. “It may reveal they are sensitive or sensitized by a product. 

SOURCE:

First author Meera Kattapuram, MD, of the Department of Internal Medicine at Mount Sinai Hospital, New York, led the study, published in the February issue of Dermatologic Surgery.  

LIMITATIONS:

Limitations include the selection of five retailers and the top 100 products from each website and the potential for ingredient list inaccuracies. 

DISCLOSURES:

The authors reported having no financial conflicts of interest. The research was supported by a grant from the National Institutes of Health/National Cancer Institute. 

A version of this article appeared on Medscape.com.

TOPLINE:

Oral antibiotics may be a safe alternative to receiving prolonged intravenous (IV) antibiotics, according to a recent observational study published in JAMA Network Open.

METHODOLOGY:

• Patients receiving antibiotics through an IV line risk developing a secondary infection; antibiotics received orally are considered safer.
• Researchers analyzed observational data from 914 adults with uncomplicated gram-negative bacteremia who received care in four hospitals in Denmark between 2018 and 2021.
• The outcomes of patients who were switched to oral antibiotics within 4 days after a positive blood culture were compared with those who continued to receive IV antibiotics for at least 5 days after the blood culture; participants in both groups received antibiotics for 7-14 days.
• Researchers assessed mortality rates over a 90-day window and used a target trial emulation method to conduct the study.

TAKEAWAY:

• Overall, 14.3% of patients who received prolonged IV treatment died, compared with 6.9% in the oral antibiotics group.
• In an intention-to-treat analysis, patients who were switched to oral antibiotics had a 22% lower risk for death within 90 days of initiation of treatment (relative risk [RR], 0.78; 95% CI, 0.60-1.10).
• In a per-protocol analysis, patients who switched to the oral route had a 1% lower odds of dying within 90 days (RR, 0.99; 95% CI, 0.70-1.40).
• Individuals who were switched to oral antibiotic treatment were younger than those who continued to receive antibiotics via the IV route (median age, 73 vs 76 years, respectively), had fewer comorbidities (four vs five), and were more likely to have community-acquired gram-negative bacteremia (89.4% vs 80.9%).

IN PRACTICE:

“These findings suggest that the mortality associated with early antibiotic stepdown treatment is comparable to that associated with receiving prolonged IV antibiotic treatment for individuals with uncomplicated gram-negative bacteremia,” the authors of the study wrote.

SOURCE:

The study was led by Sandra Tingsgård, MD, of the Center of Research & Department of Infectious Diseases at Copenhagen University Hospital–Amager and Hvidovre in Denmark.

LIMITATIONS:

The study was based on data from electronic health records, so some factors may not have been recorded or considered. The researchers identified few cases of multidrug-resistant infections, and the findings may not apply to those cases. Complicated cases and people who were not stabilized by day 4 were excluded from the analysis.

DISCLOSURES:

The authors report no disclosures or sources of funding.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral antibiotics may be a safe alternative to receiving prolonged intravenous (IV) antibiotics, according to a recent observational study published in JAMA Network Open.

METHODOLOGY:

• Patients receiving antibiotics through an IV line risk developing a secondary infection; antibiotics received orally are considered safer.
• Researchers analyzed observational data from 914 adults with uncomplicated gram-negative bacteremia who received care in four hospitals in Denmark between 2018 and 2021.
• The outcomes of patients who were switched to oral antibiotics within 4 days after a positive blood culture were compared with those who continued to receive IV antibiotics for at least 5 days after the blood culture; participants in both groups received antibiotics for 7-14 days.
• Researchers assessed mortality rates over a 90-day window and used a target trial emulation method to conduct the study.

TAKEAWAY:

• Overall, 14.3% of patients who received prolonged IV treatment died, compared with 6.9% in the oral antibiotics group.
• In an intention-to-treat analysis, patients who were switched to oral antibiotics had a 22% lower risk for death within 90 days of initiation of treatment (relative risk [RR], 0.78; 95% CI, 0.60-1.10).
• In a per-protocol analysis, patients who switched to the oral route had a 1% lower odds of dying within 90 days (RR, 0.99; 95% CI, 0.70-1.40).
• Individuals who were switched to oral antibiotic treatment were younger than those who continued to receive antibiotics via the IV route (median age, 73 vs 76 years, respectively), had fewer comorbidities (four vs five), and were more likely to have community-acquired gram-negative bacteremia (89.4% vs 80.9%).

IN PRACTICE:

“These findings suggest that the mortality associated with early antibiotic stepdown treatment is comparable to that associated with receiving prolonged IV antibiotic treatment for individuals with uncomplicated gram-negative bacteremia,” the authors of the study wrote.

SOURCE:

The study was led by Sandra Tingsgård, MD, of the Center of Research & Department of Infectious Diseases at Copenhagen University Hospital–Amager and Hvidovre in Denmark.

LIMITATIONS:

The study was based on data from electronic health records, so some factors may not have been recorded or considered. The researchers identified few cases of multidrug-resistant infections, and the findings may not apply to those cases. Complicated cases and people who were not stabilized by day 4 were excluded from the analysis.

DISCLOSURES:

The authors report no disclosures or sources of funding.

A version of this article appeared on Medscape.com.

TOPLINE:

Oral antibiotics may be a safe alternative to receiving prolonged intravenous (IV) antibiotics, according to a recent observational study published in JAMA Network Open.

METHODOLOGY:

• Patients receiving antibiotics through an IV line risk developing a secondary infection; antibiotics received orally are considered safer.
• Researchers analyzed observational data from 914 adults with uncomplicated gram-negative bacteremia who received care in four hospitals in Denmark between 2018 and 2021.
• The outcomes of patients who were switched to oral antibiotics within 4 days after a positive blood culture were compared with those who continued to receive IV antibiotics for at least 5 days after the blood culture; participants in both groups received antibiotics for 7-14 days.
• Researchers assessed mortality rates over a 90-day window and used a target trial emulation method to conduct the study.

TAKEAWAY:

• Overall, 14.3% of patients who received prolonged IV treatment died, compared with 6.9% in the oral antibiotics group.
• In an intention-to-treat analysis, patients who were switched to oral antibiotics had a 22% lower risk for death within 90 days of initiation of treatment (relative risk [RR], 0.78; 95% CI, 0.60-1.10).
• In a per-protocol analysis, patients who switched to the oral route had a 1% lower odds of dying within 90 days (RR, 0.99; 95% CI, 0.70-1.40).
• Individuals who were switched to oral antibiotic treatment were younger than those who continued to receive antibiotics via the IV route (median age, 73 vs 76 years, respectively), had fewer comorbidities (four vs five), and were more likely to have community-acquired gram-negative bacteremia (89.4% vs 80.9%).

IN PRACTICE:

“These findings suggest that the mortality associated with early antibiotic stepdown treatment is comparable to that associated with receiving prolonged IV antibiotic treatment for individuals with uncomplicated gram-negative bacteremia,” the authors of the study wrote.

SOURCE:

The study was led by Sandra Tingsgård, MD, of the Center of Research & Department of Infectious Diseases at Copenhagen University Hospital–Amager and Hvidovre in Denmark.

LIMITATIONS:

The study was based on data from electronic health records, so some factors may not have been recorded or considered. The researchers identified few cases of multidrug-resistant infections, and the findings may not apply to those cases. Complicated cases and people who were not stabilized by day 4 were excluded from the analysis.

DISCLOSURES:

The authors report no disclosures or sources of funding.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.

I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?

The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. Whether you›re a neurologist, someone involved in actually diagnosing brain death, or you›re dealing with very ill people whose families are trying to direct the kinds of things that you or the nurses can do, these guidelines, I think, are excellent. They did a wonderful job, in my view. They›ve achieved clarity.

First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.

The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.

Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.

You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.

They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.

I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.

In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.

When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.

What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.

If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.

This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.

We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.

We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.

We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.

I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.

I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?

The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. Whether you›re a neurologist, someone involved in actually diagnosing brain death, or you›re dealing with very ill people whose families are trying to direct the kinds of things that you or the nurses can do, these guidelines, I think, are excellent. They did a wonderful job, in my view. They›ve achieved clarity.

First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.

The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.

Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.

You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.

They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.

I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.

In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.

When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.

What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.

If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.

This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.

We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.

We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.

We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.

I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at the New York University Grossman School of Medicine in New York City.

I think we had a breakthrough on a very controversial subject over the past month. Over and over again, debates have been breaking out, cases have been going to court, and fights have been coming to ethics committees about brain death. How do we know what brain death is, how do we diagnose it, and what rights do families have with respect to the diagnosis?

The American Academy of Neurology decided to form a task force, and they just issued guidelines on the definition, tests to use it, and the rights of families. Whether you›re a neurologist, someone involved in actually diagnosing brain death, or you›re dealing with very ill people whose families are trying to direct the kinds of things that you or the nurses can do, these guidelines, I think, are excellent. They did a wonderful job, in my view. They›ve achieved clarity.

First, they tried to handle both adults and children. Children are, if you will, more difficult — and that’s been known — to test for brain death. Their brains are smaller. You get more interference and false signals coming from muscle or nerve activity that might be going on elsewhere in their bodies.

The guidelines say we’re going to try to see whether a person can breathe without support. If it’s an adult, one test over a 24-hour period would be sufficient. If you had them off the ventilator and they can’t breathe and show no signs of being able to do that, that’s a very fundamental test for brain death. For children, you’re going to have to do it twice. The guidelines are saying to be cautious.

Second, they say it’s very important to know the cause of the suspected brain death condition. If someone has a massive head injury, that’s different from a situation in which someone overdoses from drugs or drowns. Those conditions can be a little deceptive. In the case of drowning, sometimes the brain has protective mechanisms to protect circulation to the brain naturally for a little bit of time. I’m talking about minutes, not hours.

You want to be careful to make sure that you know the cause of the massive brain injury or insult that makes someone believe that the patient is brain-dead, whether it’s a stroke, an embolism, a bleed, a gunshot wound, or trauma to the head. Those factors really drive the certainty with which brain death should be pronounced. I think that’s very, very important.

They also said that brain death means the permanent loss of brain function. You may get a few cells still firing or you may be in a situation, because the life support is still there, where the body looks pink and perhaps might appear to still be alive to someone. When you know that the damage to the brain is so severe that there’s nothing that can be done to bring back the support of heart function, breathing, and most likely any ability to sense or feel anything, that is death.

I believe it’s very important, when talking to families, to say there are two ways that we pronounce people dead, and they’re equal: One is to say their heart has stopped, their breathing has stopped, and there’s nothing we can do to resuscitate them, which is cardiac death. The other is to say their brain has permanently ceased to function in any kind of integrated way. That means no heartbeat, no breathing, and no mental sensations. That is death.

In approaching families, it is critical that doctors and nurses don’t say, “Your relative is brain-dead.” That gives the family a sense that maybe they’re only “partially dead” or maybe there’s one key organ that has stopped working but maybe you can bring it back. Death is death. The law recognizes both cardiac death and brain death as death.

When you approach a family, if you believe that death has occurred, you say, “I’m very sorry. With regret, I have to tell you, your loved one is dead.” If they ask how you know, you can say, “We’ve determined it through brain death or through cardiac death.” You don’t give them a sense that people could be kind of dead, sort of dead, or nearly dead. Those states are comas or permanent vegetative states; they’re not the same as death.

What if the family says, “I don’t want you to do any testing. I don’t want to find out whether my relative is dead”? The American Academy of Neurology looked at this carefully and said that any test for death can be done without the permission or consent of the family. They said that because doctors need to know what steps to take to treat someone.

If a person is dead, then treatment is going to stop. It may not stop immediately. There may be issues about organ donation. There may be issues about gathering the family to come to the bedside to say goodbye, because many people think that’s more humane than saying goodbye at the morgue or in another setting.

This is all well and good, but patients cannot protect against bad news when it comes to death. We don’t want to be doing things to the dead that cost money or are futile because of death and using resources that might go to others.

We’ve got much more clarity than we have ever had with respect to the issue of brain death and how it works in any hospital. We have certain tests, including being off the ventilator and some other tests, that the guidelines supply. We know we have to be more careful with children. We want to know the etiology of the cause of the brain trauma, the devastating brain injury, to be sure that this is something that really is permanent cessation of integrated brain function.

We know that if you believe the person has died, you don’t need the consent of the family in order to do a brain-death test. You have to do it because there is no point in continuing treatment in expensive ICU settings and denying resources to others who might want to use those resources. The family can’t hold the medical team hostage.

We do know that when we approach someone with the determination, whatever it is, we should lead by saying that the person has died and then explain how that was determined, whether it be by cardiac death pronouncement — where you tried to resuscitate and the heart’s not beating — or brain-death analysis.

I’m Art Caplan at the Division of Medical Ethics at the NYU Grossman School of Medicine. Thanks for watching.

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for: Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position); serves as a contributing author and adviser for this news organization.

A version of this article appeared on Medscape.com.

The number of state psychiatric hospital beds has hit a historic low with about 11 beds per 100,000 population, a new report showed.

More than half of those beds (52%) were occupied by forensic patients, individuals with serious mental illness (SMI) who were committed to the state hospital through the criminal legal system to help establish competency for trial.

“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.

Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.

To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.

Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.

The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.

The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.

About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.

“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”

There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.

Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.

Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.

“States must strive for prevention over punishment,” the report concluded.

There was no study funding reported, nor were disclosures available.
 

A version of this article appeared on Medscape.com.

The number of state psychiatric hospital beds has hit a historic low with about 11 beds per 100,000 population, a new report showed.

More than half of those beds (52%) were occupied by forensic patients, individuals with serious mental illness (SMI) who were committed to the state hospital through the criminal legal system to help establish competency for trial.

“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.

Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.

To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.

Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.

The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.

The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.

About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.

“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”

There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.

Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.

Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.

“States must strive for prevention over punishment,” the report concluded.

There was no study funding reported, nor were disclosures available.
 

A version of this article appeared on Medscape.com.

The number of state psychiatric hospital beds has hit a historic low with about 11 beds per 100,000 population, a new report showed.

More than half of those beds (52%) were occupied by forensic patients, individuals with serious mental illness (SMI) who were committed to the state hospital through the criminal legal system to help establish competency for trial.

“The shortage of psychiatric beds has real consequences for people with SMI — some will wait months in jail despite not yet being found guilty of a crime, others will be denied admission despite being critically ill, and others still will be discharged prematurely onto the streets to free up beds, where they may grow sicker and be at an elevated risk of mortality,” wrote report coauthors Shanti Silver of the Treatment Advocacy Center (TAC) in Arlington and Elizabeth Sinclair Hanq of the National Association of State Mental Health Program Directors in Alexandria, Virginia.

Published online on January 24, Prevention Over Punishment: Finding the Right Balance of Civil and Forensic State Psychiatric Hospital Beds recommends that state and local governments work together to open additional state psychiatric hospital beds for civil and forensic patients with SMI.

To obtain data about the availability of state psychiatric hospital beds, TAC surveyed state officials from April to August 2023. Official responses were provided by 41 states and the District of Columbia.

Information for the remaining states was gathered from state websites, media articles, preexisting reports, hospital admission staff, or personal contacts living in those states.

The median occupancy rate for state-run hospitals in the new report was 90%, well above the 85% level investigators say usually signals a bed shortage. Overall, 73% of states reported occupancy rates above that level, with 11 states operating at 95% capacity.

The proportion of state psychiatric beds occupied by forensic patients has increased by 12% since 2016, largely driven by the growing number of individuals awaiting a competency determination to stand trial. Before they occupy these beds, however, people with SMI can languish in jail for months or even years, waiting for a bed to open.

About 15% of all state hospital beds and 31% of forensic beds across 34 states were occupied by individuals who had been found not guilty of a crime by reasons of insanity.

“The prioritization of admission of forensic patients has effectively created a system where someone must be arrested to access a state hospital bed,” report coauthor Lisa Dailey, TAC executive director, told this news organization. “But there are not enough beds for forensic patients either; thousands of inmates are waiting in jail on any given day for a bed to open up.”

There are several factors contributing to the scarcity of beds, including an existing hospital staffing shortage made worse by the COVID-19 pandemic and a lack of appropriate discharge facilities.

Report authors offered a number of recommendations to federal, state, and local officials to increase the availability of state-run psychiatric hospital beds, including infrastructure changes involving recruiting and retaining staff for state hospitals and funding new discharge or step-down facilities so that patients have a place to recover when they leave the hospital.

Policy changes could also help, the report noted. Policymakers should consider “dismiss and transfer” procedures to address the backlog of nearly 6000 people with SMI waiting for a state hospital bed to achieve competency to stand trial. With “dismiss and transfer,” criminal charges are dismissed or suspended while an application for civil commitment is filed in the probate court. Once a civil commitment order has been issued, the individual is released to an outpatient commitment program for treatment.

“States must strive for prevention over punishment,” the report concluded.

There was no study funding reported, nor were disclosures available.
 

A version of this article appeared on Medscape.com.

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. 'Is There a Doctor in the House?' is a Medscape Medical News series telling these stories.

Bill Madden, MD: It was a Saturday in October of 1996. I had gone to my favorite plant nursery in Tucson with my wife, Beth, and two of my kids, Zach and Katya, who were 9 years old. I went to the back of the nursery to use the bathroom, and I heard two of the workers yelling at each other. The tone was angry. 

I went back up to the front, and Zach said that he was bored. He asked if he could go to the car and get a book, so I gave him my car keys and told him to be careful crossing the street. 

Ron Quintia, DDS: It was late in the afternoon, probably close to 4 PM. I was also at the nursery picking up some plants. 

The noise came out of nowhere. Boom! Boom! Boom! I thought, Wow, that sounds like a gun. But no, it can’t be a gun. This is a plant nursery. 

BM: When I heard the rounds being fired, I knew what that sound meant. I was in the Army for 20 years doing critical care for kids. 

I turned and a young man came running toward me out of the sun. It was hard to see, but I realized a second guy was running about 10 feet behind him. Both men were screaming. 

My wife was about 10 feet away behind a raised planter with Katya. I yelled for them to get down as I dove for the ground.

The first guy, a young Hispanic man, tried to escape through some bushes. But the shooter was catching up. I recognized him. He was from Ethiopia and worked at the nursery. I had talked to him a week earlier about his life; he used to be a farmer.

Now, he was holding a 9-mm automatic — silver, very shiny. He shot the Hispanic man twice in the chest. Then he ran toward the back of the nursery. 

RQ: When I realized what was happening, I crouched down, so I couldn’t see very much. But I heard someone screaming, “He has a gun! He has a gun!” And then I heard more shots. 

BM: I yelled at my wife, “Get out!” Then I ran for the phone at the kiosk desk to call 911. This was before most people had cell phones. But the phone was hooked up to the paging system for the nursery, and I couldn’t get it to work. I turned and ran for the wounded man.

RQ: I got to the victim first. Both lungs had been hit, and I could hear he had sucking chest wounds. He was bleeding out of his mouth, saying, “I’m going to die. I’m going to die.” I told him, “You’re not going to die,” while thinking to myself, He’s going to die. 

BM: I had never met Ron before, but we started working on the patient together. Both of his lungs were collapsing. With sucking chest wounds, the critical issue is to seal up the holes. So normally, you slap a Vaseline dressing on and tape it up real good. But obviously, we didn’t have anything. 

Ron and I took off our shirts and used them to bandage the man’s chest. He wasn’t looking good, starting to turn blue. He was dying. We were yelling for someone to call an ambulance. 

And then suddenly, the shooter was back. He was standing there yelling at us to leave so he could kill the man we were helping. The 9-mil was in his hand, ready to fire. He kept screaming, “I’m not a monkey! I’m not a monkey!”

RQ: The guy was less than 10 feet from us, and we were facing down this gun that looked like a cannon. I thought, This is it. It’s curtains. I’m going to die. We’re all going to die. 

BM: I had decided I would die too. I wasn’t frightened though. It’s hard to explain. Dying was okay because I’d gotten my family away. I just had to stay alive as long as I could in order to provide for the victim. 

It’s what I signed up for when I chose to be a doc — to do whatever was needed. And if I got killed in the process, that was just part of the story. So we started talking to the shooter.

I said, “No, you’re not a monkey. You’re a man, a human being. It’s okay.” We pleaded with him to put the weapon down and not to shoot. We did not leave the patient. Finally, the shooter ran off toward the back of the nursery.

RQ: About 30 seconds after that, we heard two more shots from that direction. 

Then there were sirens, and the place was suddenly crawling with police. The paramedics came and took over. I got up and got out of the way.

BM: A young woman ran up, her mouth covered with blood. She said that there was another victim in the back. I asked a police officer to go with us to check. We started for the back when suddenly, we heard yelling and many rounds being fired. The officer ran in the direction of the shooting. 

The woman and I kept walking through rows of plants and trees. It was like moving through a jungle. Finally, we reached the other victim, an American Indian man, lying on his back. He had a chest wound and a head wound. No respirations. No radial pulse. No carotid pulse. I pronounced him dead.

Then I heard a voice calling for help. There were two women hiding nearby in the bushes. I led them to where the police cars were.

Another officer came over and told me that they had the shooter. The police had shot him in the leg and arrested him.

RQ: The police kept us there for quite some time. Meanwhile, the TV crews arrived. I had a black Toyota 4Runner at the time. My family was home watching the news, and a bulletin came on about a shooting in Midtown. The camera panned around the area, and my wife saw our car on the street! They were all worried until I could call and let them know that I was okay.

BM: As we waited, the sun went down, and I was getting cold. My shirt was a bloody mess. Ron and I just sat there quietly, not saying a whole heck of a lot. 

Finally, an officer took our statements, a detective interviewed us, and they let us leave. I called Beth, and she and the kids came and got me. 

At home, we talked to the kids, letting them express their fears. We put them to bed. I didn’t sleep that night. 

RQ: I can’t describe how weird it was going home with this guy’s blood on my body. Needing to take a bath. Trying to get rid of the stench of what could have been a brutal killing. But it wasn’t. At least, not for our patient. 

Thankfully, there are three hospitals within a stone’s throw of the nursery. The paramedics got the man we helped to Tucson Medical Center and into the OR immediately. Then the general surgeons could get chest tubes in him to reinflate his lungs.

BM: The doctor who treated him called me later. He said that when they put the chest tubes in, they got a liter and a half of blood out of him. If it had taken another 10 minutes or so to get there, he very likely would’ve been dead on arrival in the emergency room. 

RQ: I checked on him at the hospital the next day, and he was doing okay. That was the last time I saw him. 

I only saw the shooter again in court. Dr. Madden and I were both called as witnesses at his trial. He was tried for capital murder and 12 charges of aggravated assault for every person who was at the nursery. He was found guilty on all of them and sentenced to 35 years to life in prison. 

BM: I don’t think the shooter was very well represented in court. It’s not that he didn’t kill one person and critically wound another. He did, and he deserves to be punished for that. But his story wasn’t told.

I knew that during the civil war in Ethiopia, his family had been killed by Cuban soldiers sent there to help the pro-communist government. In a way, I thought of him as two different people: the shooter and the farmer. They are both in prison, but only one of them deserves to be there.

After it happened, I wanted to visit the farmer in the hospital and tell him that, despite what he had done, he was not alone. Our family cared about him. The police wouldn’t let me see him, so I asked the Catholic chaplain of the hospital to go. He gave him my message: that despite all the sorrow and pain, in some distant way, I understood. I respected him as a human being. And I was praying for him.

RQ: It’s safe to say that the experience will affect me forever. For months, even years afterward, if somebody would ask me about what happened, I would start to cry. I would sit in the parking lot of my favorite running trail and worry about the people driving in. If I heard a car backfire, I thought about gunshots. 

It was terrifying. And thank God I’ve never found myself in that position again. But I suspect I’d probably react the same way. This is our calling. It’s what we do — protecting other people and taking care of them.

BM: I’d always wondered what I would do in a situation like this. I knew I could function in a critical care situation, a child in a hospital or in the back of an ambulance. But could I do it when my own life was threatened? I found out that I could, and that was really important to me. 

RQ: It was one of those great lessons in life. You realize how lucky you are and that your life can be snatched away from you in a millisecond. I went to a nursery to buy plants for my yard, and instead I ended up helping to save a life.Bill Madden, MD, is a retired US Army colonel and pediatrician, formerly an associate professor of Clinical Pediatrics at the College of Medicine of the University of Arizona, Tucson. 

Ron Quintia, DDS, is an oral and maxillofacial surgeon at Southern Arizona Oral & Maxillofacial Surgery in Tucson, Arizona. 

A version of this article appeared on Medscape.com .

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. 'Is There a Doctor in the House?' is a Medscape Medical News series telling these stories.

Bill Madden, MD: It was a Saturday in October of 1996. I had gone to my favorite plant nursery in Tucson with my wife, Beth, and two of my kids, Zach and Katya, who were 9 years old. I went to the back of the nursery to use the bathroom, and I heard two of the workers yelling at each other. The tone was angry. 

I went back up to the front, and Zach said that he was bored. He asked if he could go to the car and get a book, so I gave him my car keys and told him to be careful crossing the street. 

Ron Quintia, DDS: It was late in the afternoon, probably close to 4 PM. I was also at the nursery picking up some plants. 

The noise came out of nowhere. Boom! Boom! Boom! I thought, Wow, that sounds like a gun. But no, it can’t be a gun. This is a plant nursery. 

BM: When I heard the rounds being fired, I knew what that sound meant. I was in the Army for 20 years doing critical care for kids. 

I turned and a young man came running toward me out of the sun. It was hard to see, but I realized a second guy was running about 10 feet behind him. Both men were screaming. 

My wife was about 10 feet away behind a raised planter with Katya. I yelled for them to get down as I dove for the ground.

The first guy, a young Hispanic man, tried to escape through some bushes. But the shooter was catching up. I recognized him. He was from Ethiopia and worked at the nursery. I had talked to him a week earlier about his life; he used to be a farmer.

Now, he was holding a 9-mm automatic — silver, very shiny. He shot the Hispanic man twice in the chest. Then he ran toward the back of the nursery. 

RQ: When I realized what was happening, I crouched down, so I couldn’t see very much. But I heard someone screaming, “He has a gun! He has a gun!” And then I heard more shots. 

BM: I yelled at my wife, “Get out!” Then I ran for the phone at the kiosk desk to call 911. This was before most people had cell phones. But the phone was hooked up to the paging system for the nursery, and I couldn’t get it to work. I turned and ran for the wounded man.

RQ: I got to the victim first. Both lungs had been hit, and I could hear he had sucking chest wounds. He was bleeding out of his mouth, saying, “I’m going to die. I’m going to die.” I told him, “You’re not going to die,” while thinking to myself, He’s going to die. 

BM: I had never met Ron before, but we started working on the patient together. Both of his lungs were collapsing. With sucking chest wounds, the critical issue is to seal up the holes. So normally, you slap a Vaseline dressing on and tape it up real good. But obviously, we didn’t have anything. 

Ron and I took off our shirts and used them to bandage the man’s chest. He wasn’t looking good, starting to turn blue. He was dying. We were yelling for someone to call an ambulance. 

And then suddenly, the shooter was back. He was standing there yelling at us to leave so he could kill the man we were helping. The 9-mil was in his hand, ready to fire. He kept screaming, “I’m not a monkey! I’m not a monkey!”

RQ: The guy was less than 10 feet from us, and we were facing down this gun that looked like a cannon. I thought, This is it. It’s curtains. I’m going to die. We’re all going to die. 

BM: I had decided I would die too. I wasn’t frightened though. It’s hard to explain. Dying was okay because I’d gotten my family away. I just had to stay alive as long as I could in order to provide for the victim. 

It’s what I signed up for when I chose to be a doc — to do whatever was needed. And if I got killed in the process, that was just part of the story. So we started talking to the shooter.

I said, “No, you’re not a monkey. You’re a man, a human being. It’s okay.” We pleaded with him to put the weapon down and not to shoot. We did not leave the patient. Finally, the shooter ran off toward the back of the nursery.

RQ: About 30 seconds after that, we heard two more shots from that direction. 

Then there were sirens, and the place was suddenly crawling with police. The paramedics came and took over. I got up and got out of the way.

BM: A young woman ran up, her mouth covered with blood. She said that there was another victim in the back. I asked a police officer to go with us to check. We started for the back when suddenly, we heard yelling and many rounds being fired. The officer ran in the direction of the shooting. 

The woman and I kept walking through rows of plants and trees. It was like moving through a jungle. Finally, we reached the other victim, an American Indian man, lying on his back. He had a chest wound and a head wound. No respirations. No radial pulse. No carotid pulse. I pronounced him dead.

Then I heard a voice calling for help. There were two women hiding nearby in the bushes. I led them to where the police cars were.

Another officer came over and told me that they had the shooter. The police had shot him in the leg and arrested him.

RQ: The police kept us there for quite some time. Meanwhile, the TV crews arrived. I had a black Toyota 4Runner at the time. My family was home watching the news, and a bulletin came on about a shooting in Midtown. The camera panned around the area, and my wife saw our car on the street! They were all worried until I could call and let them know that I was okay.

BM: As we waited, the sun went down, and I was getting cold. My shirt was a bloody mess. Ron and I just sat there quietly, not saying a whole heck of a lot. 

Finally, an officer took our statements, a detective interviewed us, and they let us leave. I called Beth, and she and the kids came and got me. 

At home, we talked to the kids, letting them express their fears. We put them to bed. I didn’t sleep that night. 

RQ: I can’t describe how weird it was going home with this guy’s blood on my body. Needing to take a bath. Trying to get rid of the stench of what could have been a brutal killing. But it wasn’t. At least, not for our patient. 

Thankfully, there are three hospitals within a stone’s throw of the nursery. The paramedics got the man we helped to Tucson Medical Center and into the OR immediately. Then the general surgeons could get chest tubes in him to reinflate his lungs.

BM: The doctor who treated him called me later. He said that when they put the chest tubes in, they got a liter and a half of blood out of him. If it had taken another 10 minutes or so to get there, he very likely would’ve been dead on arrival in the emergency room. 

RQ: I checked on him at the hospital the next day, and he was doing okay. That was the last time I saw him. 

I only saw the shooter again in court. Dr. Madden and I were both called as witnesses at his trial. He was tried for capital murder and 12 charges of aggravated assault for every person who was at the nursery. He was found guilty on all of them and sentenced to 35 years to life in prison. 

BM: I don’t think the shooter was very well represented in court. It’s not that he didn’t kill one person and critically wound another. He did, and he deserves to be punished for that. But his story wasn’t told.

I knew that during the civil war in Ethiopia, his family had been killed by Cuban soldiers sent there to help the pro-communist government. In a way, I thought of him as two different people: the shooter and the farmer. They are both in prison, but only one of them deserves to be there.

After it happened, I wanted to visit the farmer in the hospital and tell him that, despite what he had done, he was not alone. Our family cared about him. The police wouldn’t let me see him, so I asked the Catholic chaplain of the hospital to go. He gave him my message: that despite all the sorrow and pain, in some distant way, I understood. I respected him as a human being. And I was praying for him.

RQ: It’s safe to say that the experience will affect me forever. For months, even years afterward, if somebody would ask me about what happened, I would start to cry. I would sit in the parking lot of my favorite running trail and worry about the people driving in. If I heard a car backfire, I thought about gunshots. 

It was terrifying. And thank God I’ve never found myself in that position again. But I suspect I’d probably react the same way. This is our calling. It’s what we do — protecting other people and taking care of them.

BM: I’d always wondered what I would do in a situation like this. I knew I could function in a critical care situation, a child in a hospital or in the back of an ambulance. But could I do it when my own life was threatened? I found out that I could, and that was really important to me. 

RQ: It was one of those great lessons in life. You realize how lucky you are and that your life can be snatched away from you in a millisecond. I went to a nursery to buy plants for my yard, and instead I ended up helping to save a life.Bill Madden, MD, is a retired US Army colonel and pediatrician, formerly an associate professor of Clinical Pediatrics at the College of Medicine of the University of Arizona, Tucson. 

Ron Quintia, DDS, is an oral and maxillofacial surgeon at Southern Arizona Oral & Maxillofacial Surgery in Tucson, Arizona. 

A version of this article appeared on Medscape.com .

Emergencies happen anywhere and anytime, and sometimes, medical professionals find themselves in situations where they are the only ones who can help. 'Is There a Doctor in the House?' is a Medscape Medical News series telling these stories.

Bill Madden, MD: It was a Saturday in October of 1996. I had gone to my favorite plant nursery in Tucson with my wife, Beth, and two of my kids, Zach and Katya, who were 9 years old. I went to the back of the nursery to use the bathroom, and I heard two of the workers yelling at each other. The tone was angry. 

I went back up to the front, and Zach said that he was bored. He asked if he could go to the car and get a book, so I gave him my car keys and told him to be careful crossing the street. 

Ron Quintia, DDS: It was late in the afternoon, probably close to 4 PM. I was also at the nursery picking up some plants. 

The noise came out of nowhere. Boom! Boom! Boom! I thought, Wow, that sounds like a gun. But no, it can’t be a gun. This is a plant nursery. 

BM: When I heard the rounds being fired, I knew what that sound meant. I was in the Army for 20 years doing critical care for kids. 

I turned and a young man came running toward me out of the sun. It was hard to see, but I realized a second guy was running about 10 feet behind him. Both men were screaming. 

My wife was about 10 feet away behind a raised planter with Katya. I yelled for them to get down as I dove for the ground.

The first guy, a young Hispanic man, tried to escape through some bushes. But the shooter was catching up. I recognized him. He was from Ethiopia and worked at the nursery. I had talked to him a week earlier about his life; he used to be a farmer.

Now, he was holding a 9-mm automatic — silver, very shiny. He shot the Hispanic man twice in the chest. Then he ran toward the back of the nursery. 

RQ: When I realized what was happening, I crouched down, so I couldn’t see very much. But I heard someone screaming, “He has a gun! He has a gun!” And then I heard more shots. 

BM: I yelled at my wife, “Get out!” Then I ran for the phone at the kiosk desk to call 911. This was before most people had cell phones. But the phone was hooked up to the paging system for the nursery, and I couldn’t get it to work. I turned and ran for the wounded man.

RQ: I got to the victim first. Both lungs had been hit, and I could hear he had sucking chest wounds. He was bleeding out of his mouth, saying, “I’m going to die. I’m going to die.” I told him, “You’re not going to die,” while thinking to myself, He’s going to die. 

BM: I had never met Ron before, but we started working on the patient together. Both of his lungs were collapsing. With sucking chest wounds, the critical issue is to seal up the holes. So normally, you slap a Vaseline dressing on and tape it up real good. But obviously, we didn’t have anything. 

Ron and I took off our shirts and used them to bandage the man’s chest. He wasn’t looking good, starting to turn blue. He was dying. We were yelling for someone to call an ambulance. 

And then suddenly, the shooter was back. He was standing there yelling at us to leave so he could kill the man we were helping. The 9-mil was in his hand, ready to fire. He kept screaming, “I’m not a monkey! I’m not a monkey!”

RQ: The guy was less than 10 feet from us, and we were facing down this gun that looked like a cannon. I thought, This is it. It’s curtains. I’m going to die. We’re all going to die. 

BM: I had decided I would die too. I wasn’t frightened though. It’s hard to explain. Dying was okay because I’d gotten my family away. I just had to stay alive as long as I could in order to provide for the victim. 

It’s what I signed up for when I chose to be a doc — to do whatever was needed. And if I got killed in the process, that was just part of the story. So we started talking to the shooter.

I said, “No, you’re not a monkey. You’re a man, a human being. It’s okay.” We pleaded with him to put the weapon down and not to shoot. We did not leave the patient. Finally, the shooter ran off toward the back of the nursery.

RQ: About 30 seconds after that, we heard two more shots from that direction. 

Then there were sirens, and the place was suddenly crawling with police. The paramedics came and took over. I got up and got out of the way.

BM: A young woman ran up, her mouth covered with blood. She said that there was another victim in the back. I asked a police officer to go with us to check. We started for the back when suddenly, we heard yelling and many rounds being fired. The officer ran in the direction of the shooting. 

The woman and I kept walking through rows of plants and trees. It was like moving through a jungle. Finally, we reached the other victim, an American Indian man, lying on his back. He had a chest wound and a head wound. No respirations. No radial pulse. No carotid pulse. I pronounced him dead.

Then I heard a voice calling for help. There were two women hiding nearby in the bushes. I led them to where the police cars were.

Another officer came over and told me that they had the shooter. The police had shot him in the leg and arrested him.

RQ: The police kept us there for quite some time. Meanwhile, the TV crews arrived. I had a black Toyota 4Runner at the time. My family was home watching the news, and a bulletin came on about a shooting in Midtown. The camera panned around the area, and my wife saw our car on the street! They were all worried until I could call and let them know that I was okay.

BM: As we waited, the sun went down, and I was getting cold. My shirt was a bloody mess. Ron and I just sat there quietly, not saying a whole heck of a lot. 

Finally, an officer took our statements, a detective interviewed us, and they let us leave. I called Beth, and she and the kids came and got me. 

At home, we talked to the kids, letting them express their fears. We put them to bed. I didn’t sleep that night. 

RQ: I can’t describe how weird it was going home with this guy’s blood on my body. Needing to take a bath. Trying to get rid of the stench of what could have been a brutal killing. But it wasn’t. At least, not for our patient. 

Thankfully, there are three hospitals within a stone’s throw of the nursery. The paramedics got the man we helped to Tucson Medical Center and into the OR immediately. Then the general surgeons could get chest tubes in him to reinflate his lungs.

BM: The doctor who treated him called me later. He said that when they put the chest tubes in, they got a liter and a half of blood out of him. If it had taken another 10 minutes or so to get there, he very likely would’ve been dead on arrival in the emergency room. 

RQ: I checked on him at the hospital the next day, and he was doing okay. That was the last time I saw him. 

I only saw the shooter again in court. Dr. Madden and I were both called as witnesses at his trial. He was tried for capital murder and 12 charges of aggravated assault for every person who was at the nursery. He was found guilty on all of them and sentenced to 35 years to life in prison. 

BM: I don’t think the shooter was very well represented in court. It’s not that he didn’t kill one person and critically wound another. He did, and he deserves to be punished for that. But his story wasn’t told.

I knew that during the civil war in Ethiopia, his family had been killed by Cuban soldiers sent there to help the pro-communist government. In a way, I thought of him as two different people: the shooter and the farmer. They are both in prison, but only one of them deserves to be there.

After it happened, I wanted to visit the farmer in the hospital and tell him that, despite what he had done, he was not alone. Our family cared about him. The police wouldn’t let me see him, so I asked the Catholic chaplain of the hospital to go. He gave him my message: that despite all the sorrow and pain, in some distant way, I understood. I respected him as a human being. And I was praying for him.

RQ: It’s safe to say that the experience will affect me forever. For months, even years afterward, if somebody would ask me about what happened, I would start to cry. I would sit in the parking lot of my favorite running trail and worry about the people driving in. If I heard a car backfire, I thought about gunshots. 

It was terrifying. And thank God I’ve never found myself in that position again. But I suspect I’d probably react the same way. This is our calling. It’s what we do — protecting other people and taking care of them.

BM: I’d always wondered what I would do in a situation like this. I knew I could function in a critical care situation, a child in a hospital or in the back of an ambulance. But could I do it when my own life was threatened? I found out that I could, and that was really important to me. 

RQ: It was one of those great lessons in life. You realize how lucky you are and that your life can be snatched away from you in a millisecond. I went to a nursery to buy plants for my yard, and instead I ended up helping to save a life.Bill Madden, MD, is a retired US Army colonel and pediatrician, formerly an associate professor of Clinical Pediatrics at the College of Medicine of the University of Arizona, Tucson. 

Ron Quintia, DDS, is an oral and maxillofacial surgeon at Southern Arizona Oral & Maxillofacial Surgery in Tucson, Arizona. 

A version of this article appeared on Medscape.com .