Feature

Cancer care is not a top priority for the United Nations agency that is helping Ukrainian refugees across the border into neighboring countries, which makes the role of oncology groups vitally important.

“They’re trying to deal with an extremely vulnerable and traumatized population – children who’ve lost their families, elderly who are confused and potentially abandoned,” commented Richard Sullivan, MD, PhD.

“The triage that’s happening on the border is not focusing on noncommunicable diseases,” he continued. “We know from previous crises that many cancer patients are lost; they simply do not present with their symptoms once they become refugees, and that’s going to become a really big issue.”

Oncology groups are needed to “provide the navigation, the treatment, and also the intelligence to ensure we deliver excellent cancer care where it’s needed for our Ukrainian friends,” he added. Dr. Sullivan is a member of the World Health Organization’s Emergency Committee and is director of the Institute of Cancer Policy at King’s College London.

He was speaking at a virtual briefing organized by the American Society of Clinical Oncology (ASCO) and the European Cancer Organisation (ECO), which have joined forces to centralize cancer care efforts.

With an estimated 3.3 million refugees having already crossed Ukraine’s borders, neighboring countries are experiencing an approximately 5% increase in their overall populations, making increased demand for cancer care inevitable, said Dr. Sullivan.

“Suggestions are that with 4 million refugees, you’re going to be looking at an increase of 13,000-16,000 cancer patients per month. ... But it will take time for the issue to evolve. At the moment, people are not being overwhelmed ... but there’s no doubt cancer care capacity for host countries is going to be an issue in the future.”

So far, about 2 million refugees are in Poland, where cancer centers have experienced a 10% increase in new patients since the war started, said Piotr Rutkowski, MD, PhD, professor of surgical oncology at the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Warsaw.

“Of course, our resources are limited,” he said, adding that efforts are underway to accredit Ukrainian health care workers to work in Poland. “It’s unpredictable how the health care system in Europe can overcome these difficulties.”

“Until now, I don’t think any cancer patients have not received care, so still, we are in a positive situation, but the waiting list can enlarge in the near future,” Dr. Rutkowsli commented.

Indeed, the anticipated increase will “likely exceed the possibilities of the Polish health system” soon, warned Jacek Jassem, MD, PhD, professor of clinical oncology and radiotherapy and the head of the department of oncology and radiotherapy at the Medical University of Gdansk, Poland.

Although there is an EU international agreement for a more widespread allocation of cancer patients, “when they come to Poland, many of them want to be treated in Poland, because they have family here, the language is more familiar.”

Dr. Jassem suggests the best way to avoid overwhelming host cancer centers is to triage patients directly from Ukraine. “Some therapies shouldn’t be interrupted. So, for example, radiotherapy started in Ukraine should be continued there, but otherwise, chemotherapy can be continued elsewhere, surgery may be postponed and done elsewhere. These are the decisions that should be considered in Ukraine, and then patients who are selected for particular therapies should be reallocated to other countries,” he suggested.

Romania has seen an influx of about 400,000 refugees, including cancer patients seeking systemic therapy, radiotherapy, or follow-up, said Nicoleta Antone, MD, a medical oncologist at the Cancer Institute of Ion Chiricuta in Cluj-Napoca, Romania. “We have seen patients mainly with breast cancer because most of the refugees [with cancer] are women looking for systemic therapy, but also all the other tumor types, both solid and hematologic tumors.”

Dr. Sullivan says attempts by EU member states to address cancer needs are complicated by the fact that many refugees are still on the move. They have been passing through their initial host countries and moving on to Greece, Slovenia, Austria, Germany, Italy, and Turkey, “making the therapeutic geographies at any potential time quite challenging to keep an eye on.” Other countries, such as Moldova, are not part of the EU, “so we dealing with some really quite complex political and financial issues.”

The situation calls for a broader approach to refugees generally, he added. “We’re talking free cancer care for Ukrainian patients, but there’s also, of course, this dialogue of ensuring there’s free care for all refugees. Europe already has a large refugee contingent from other countries, so there’s no doubt this is an opportunity to talk more broadly about cancer care for refugees and also progressive universalism.

“You can’t have rules for one set of patients and a different set of rules for another set of patients, so there’s going to be a real issue around fairness and equity which Europe is going to have to address,” he said.

In an attempt, ASCO and ECO have joined forces in a special network, noted Julie Gralow, MD, chief medical officer at ASCO.

“The ECO/ASCO Special Network is all about collaboration and coordination across professional societies, across cancer patient groups, across academic and other clinical centers. We’re providing information in the various national languages and trying to amplify the work that each of us is doing. ... We’re sharing intelligence, regular reports from the field, information, experience, and most of all, contacts. We’re all being approached individually about people who need help or people who want to help, and we’re trying to bring this all together in a focused way.”

Separately, there is also an ASCO resource page, as well as an ECO resource page.

The American Cancer Society also has patient resources on their site, including a 24-hour international call center in multiple languages and a Volunteer Corp of Clinicians, which currently has 123 active volunteers (and another 300 applicants) available to answer questions.

Europe and other countries must consider both a medium and a long-term commitment to refugees with cancer, said Dr. Sullivan. “Because even if the war stopped tomorrow, it’s going to take between a year and a year and a half to rebuild cancer care in Ukraine.”

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

Cancer care is not a top priority for the United Nations agency that is helping Ukrainian refugees across the border into neighboring countries, which makes the role of oncology groups vitally important.

“They’re trying to deal with an extremely vulnerable and traumatized population – children who’ve lost their families, elderly who are confused and potentially abandoned,” commented Richard Sullivan, MD, PhD.

“The triage that’s happening on the border is not focusing on noncommunicable diseases,” he continued. “We know from previous crises that many cancer patients are lost; they simply do not present with their symptoms once they become refugees, and that’s going to become a really big issue.”

Oncology groups are needed to “provide the navigation, the treatment, and also the intelligence to ensure we deliver excellent cancer care where it’s needed for our Ukrainian friends,” he added. Dr. Sullivan is a member of the World Health Organization’s Emergency Committee and is director of the Institute of Cancer Policy at King’s College London.

He was speaking at a virtual briefing organized by the American Society of Clinical Oncology (ASCO) and the European Cancer Organisation (ECO), which have joined forces to centralize cancer care efforts.

With an estimated 3.3 million refugees having already crossed Ukraine’s borders, neighboring countries are experiencing an approximately 5% increase in their overall populations, making increased demand for cancer care inevitable, said Dr. Sullivan.

“Suggestions are that with 4 million refugees, you’re going to be looking at an increase of 13,000-16,000 cancer patients per month. ... But it will take time for the issue to evolve. At the moment, people are not being overwhelmed ... but there’s no doubt cancer care capacity for host countries is going to be an issue in the future.”

So far, about 2 million refugees are in Poland, where cancer centers have experienced a 10% increase in new patients since the war started, said Piotr Rutkowski, MD, PhD, professor of surgical oncology at the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Warsaw.

“Of course, our resources are limited,” he said, adding that efforts are underway to accredit Ukrainian health care workers to work in Poland. “It’s unpredictable how the health care system in Europe can overcome these difficulties.”

“Until now, I don’t think any cancer patients have not received care, so still, we are in a positive situation, but the waiting list can enlarge in the near future,” Dr. Rutkowsli commented.

Indeed, the anticipated increase will “likely exceed the possibilities of the Polish health system” soon, warned Jacek Jassem, MD, PhD, professor of clinical oncology and radiotherapy and the head of the department of oncology and radiotherapy at the Medical University of Gdansk, Poland.

Although there is an EU international agreement for a more widespread allocation of cancer patients, “when they come to Poland, many of them want to be treated in Poland, because they have family here, the language is more familiar.”

Dr. Jassem suggests the best way to avoid overwhelming host cancer centers is to triage patients directly from Ukraine. “Some therapies shouldn’t be interrupted. So, for example, radiotherapy started in Ukraine should be continued there, but otherwise, chemotherapy can be continued elsewhere, surgery may be postponed and done elsewhere. These are the decisions that should be considered in Ukraine, and then patients who are selected for particular therapies should be reallocated to other countries,” he suggested.

Romania has seen an influx of about 400,000 refugees, including cancer patients seeking systemic therapy, radiotherapy, or follow-up, said Nicoleta Antone, MD, a medical oncologist at the Cancer Institute of Ion Chiricuta in Cluj-Napoca, Romania. “We have seen patients mainly with breast cancer because most of the refugees [with cancer] are women looking for systemic therapy, but also all the other tumor types, both solid and hematologic tumors.”

Dr. Sullivan says attempts by EU member states to address cancer needs are complicated by the fact that many refugees are still on the move. They have been passing through their initial host countries and moving on to Greece, Slovenia, Austria, Germany, Italy, and Turkey, “making the therapeutic geographies at any potential time quite challenging to keep an eye on.” Other countries, such as Moldova, are not part of the EU, “so we dealing with some really quite complex political and financial issues.”

The situation calls for a broader approach to refugees generally, he added. “We’re talking free cancer care for Ukrainian patients, but there’s also, of course, this dialogue of ensuring there’s free care for all refugees. Europe already has a large refugee contingent from other countries, so there’s no doubt this is an opportunity to talk more broadly about cancer care for refugees and also progressive universalism.

“You can’t have rules for one set of patients and a different set of rules for another set of patients, so there’s going to be a real issue around fairness and equity which Europe is going to have to address,” he said.

In an attempt, ASCO and ECO have joined forces in a special network, noted Julie Gralow, MD, chief medical officer at ASCO.

“The ECO/ASCO Special Network is all about collaboration and coordination across professional societies, across cancer patient groups, across academic and other clinical centers. We’re providing information in the various national languages and trying to amplify the work that each of us is doing. ... We’re sharing intelligence, regular reports from the field, information, experience, and most of all, contacts. We’re all being approached individually about people who need help or people who want to help, and we’re trying to bring this all together in a focused way.”

Separately, there is also an ASCO resource page, as well as an ECO resource page.

The American Cancer Society also has patient resources on their site, including a 24-hour international call center in multiple languages and a Volunteer Corp of Clinicians, which currently has 123 active volunteers (and another 300 applicants) available to answer questions.

Europe and other countries must consider both a medium and a long-term commitment to refugees with cancer, said Dr. Sullivan. “Because even if the war stopped tomorrow, it’s going to take between a year and a year and a half to rebuild cancer care in Ukraine.”

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

Cancer care is not a top priority for the United Nations agency that is helping Ukrainian refugees across the border into neighboring countries, which makes the role of oncology groups vitally important.

“They’re trying to deal with an extremely vulnerable and traumatized population – children who’ve lost their families, elderly who are confused and potentially abandoned,” commented Richard Sullivan, MD, PhD.

“The triage that’s happening on the border is not focusing on noncommunicable diseases,” he continued. “We know from previous crises that many cancer patients are lost; they simply do not present with their symptoms once they become refugees, and that’s going to become a really big issue.”

Oncology groups are needed to “provide the navigation, the treatment, and also the intelligence to ensure we deliver excellent cancer care where it’s needed for our Ukrainian friends,” he added. Dr. Sullivan is a member of the World Health Organization’s Emergency Committee and is director of the Institute of Cancer Policy at King’s College London.

He was speaking at a virtual briefing organized by the American Society of Clinical Oncology (ASCO) and the European Cancer Organisation (ECO), which have joined forces to centralize cancer care efforts.

With an estimated 3.3 million refugees having already crossed Ukraine’s borders, neighboring countries are experiencing an approximately 5% increase in their overall populations, making increased demand for cancer care inevitable, said Dr. Sullivan.

“Suggestions are that with 4 million refugees, you’re going to be looking at an increase of 13,000-16,000 cancer patients per month. ... But it will take time for the issue to evolve. At the moment, people are not being overwhelmed ... but there’s no doubt cancer care capacity for host countries is going to be an issue in the future.”

So far, about 2 million refugees are in Poland, where cancer centers have experienced a 10% increase in new patients since the war started, said Piotr Rutkowski, MD, PhD, professor of surgical oncology at the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Warsaw.

“Of course, our resources are limited,” he said, adding that efforts are underway to accredit Ukrainian health care workers to work in Poland. “It’s unpredictable how the health care system in Europe can overcome these difficulties.”

“Until now, I don’t think any cancer patients have not received care, so still, we are in a positive situation, but the waiting list can enlarge in the near future,” Dr. Rutkowsli commented.

Indeed, the anticipated increase will “likely exceed the possibilities of the Polish health system” soon, warned Jacek Jassem, MD, PhD, professor of clinical oncology and radiotherapy and the head of the department of oncology and radiotherapy at the Medical University of Gdansk, Poland.

Although there is an EU international agreement for a more widespread allocation of cancer patients, “when they come to Poland, many of them want to be treated in Poland, because they have family here, the language is more familiar.”

Dr. Jassem suggests the best way to avoid overwhelming host cancer centers is to triage patients directly from Ukraine. “Some therapies shouldn’t be interrupted. So, for example, radiotherapy started in Ukraine should be continued there, but otherwise, chemotherapy can be continued elsewhere, surgery may be postponed and done elsewhere. These are the decisions that should be considered in Ukraine, and then patients who are selected for particular therapies should be reallocated to other countries,” he suggested.

Romania has seen an influx of about 400,000 refugees, including cancer patients seeking systemic therapy, radiotherapy, or follow-up, said Nicoleta Antone, MD, a medical oncologist at the Cancer Institute of Ion Chiricuta in Cluj-Napoca, Romania. “We have seen patients mainly with breast cancer because most of the refugees [with cancer] are women looking for systemic therapy, but also all the other tumor types, both solid and hematologic tumors.”

Dr. Sullivan says attempts by EU member states to address cancer needs are complicated by the fact that many refugees are still on the move. They have been passing through their initial host countries and moving on to Greece, Slovenia, Austria, Germany, Italy, and Turkey, “making the therapeutic geographies at any potential time quite challenging to keep an eye on.” Other countries, such as Moldova, are not part of the EU, “so we dealing with some really quite complex political and financial issues.”

The situation calls for a broader approach to refugees generally, he added. “We’re talking free cancer care for Ukrainian patients, but there’s also, of course, this dialogue of ensuring there’s free care for all refugees. Europe already has a large refugee contingent from other countries, so there’s no doubt this is an opportunity to talk more broadly about cancer care for refugees and also progressive universalism.

“You can’t have rules for one set of patients and a different set of rules for another set of patients, so there’s going to be a real issue around fairness and equity which Europe is going to have to address,” he said.

In an attempt, ASCO and ECO have joined forces in a special network, noted Julie Gralow, MD, chief medical officer at ASCO.

“The ECO/ASCO Special Network is all about collaboration and coordination across professional societies, across cancer patient groups, across academic and other clinical centers. We’re providing information in the various national languages and trying to amplify the work that each of us is doing. ... We’re sharing intelligence, regular reports from the field, information, experience, and most of all, contacts. We’re all being approached individually about people who need help or people who want to help, and we’re trying to bring this all together in a focused way.”

Separately, there is also an ASCO resource page, as well as an ECO resource page.

The American Cancer Society also has patient resources on their site, including a 24-hour international call center in multiple languages and a Volunteer Corp of Clinicians, which currently has 123 active volunteers (and another 300 applicants) available to answer questions.

Europe and other countries must consider both a medium and a long-term commitment to refugees with cancer, said Dr. Sullivan. “Because even if the war stopped tomorrow, it’s going to take between a year and a year and a half to rebuild cancer care in Ukraine.”

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

Pfizer is voluntarily recalling some antihypertensive medications because of unacceptable levels of a potential carcinogen, the company announced. 

The affected products are quinapril HCI/hydrochlorothiazide (Accuretic) tablets that Pfizer distributes, and two authorized generics, quinapril plus hydrochlorothiazide and quinapril HCI/hydrochlorothiazide, distributed by Greenstone. The drugs have been withdrawn because of the presence of nitrosamine, N-nitroso-quinapril.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” Pfizer said in a news release.

The tablets are indicated for the treatment of hypertension. Patients currently taking the products are asked to consult with their doctor about alternative treatment options.

To date, there have been no reports of adverse events related to the recall, the company said.

In all, Pfizer is recalling six lots of Accuretic tablets (two at 10 mg/12.5 mg, three at 20 mg/12.5 mg, and one at 20 mg/25 mg), one lot of quinapril plus hydrochlorothiazide 20-mg/25-mg tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets (three at 20 mg/12.5 mg and one at 20 mg/25 mg)

The recalled tablets were sold in 90-count bottles distributed in the United States and Puerto Rico between November 2019 and March 2022. Product codes and lot numbers of the recalled medications are listed on the Pfizer website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-843-0247 Monday through Friday from 8 a.m. to 5 p.m. ET for instructions on how to return their product and obtain reimbursement.

Health care providers with medical questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday 8 a.m. to 9 p.m. ET.

Providers should report adverse reactions or quality problems they experience using these tablets to Pfizer either by telephone at 800-438-1985, option 1, by regular mail or by fax, or to the Food and Drug Administration’s MedWatch program.

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

Pfizer is voluntarily recalling some antihypertensive medications because of unacceptable levels of a potential carcinogen, the company announced. 

The affected products are quinapril HCI/hydrochlorothiazide (Accuretic) tablets that Pfizer distributes, and two authorized generics, quinapril plus hydrochlorothiazide and quinapril HCI/hydrochlorothiazide, distributed by Greenstone. The drugs have been withdrawn because of the presence of nitrosamine, N-nitroso-quinapril.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” Pfizer said in a news release.

The tablets are indicated for the treatment of hypertension. Patients currently taking the products are asked to consult with their doctor about alternative treatment options.

To date, there have been no reports of adverse events related to the recall, the company said.

In all, Pfizer is recalling six lots of Accuretic tablets (two at 10 mg/12.5 mg, three at 20 mg/12.5 mg, and one at 20 mg/25 mg), one lot of quinapril plus hydrochlorothiazide 20-mg/25-mg tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets (three at 20 mg/12.5 mg and one at 20 mg/25 mg)

The recalled tablets were sold in 90-count bottles distributed in the United States and Puerto Rico between November 2019 and March 2022. Product codes and lot numbers of the recalled medications are listed on the Pfizer website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-843-0247 Monday through Friday from 8 a.m. to 5 p.m. ET for instructions on how to return their product and obtain reimbursement.

Health care providers with medical questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday 8 a.m. to 9 p.m. ET.

Providers should report adverse reactions or quality problems they experience using these tablets to Pfizer either by telephone at 800-438-1985, option 1, by regular mail or by fax, or to the Food and Drug Administration’s MedWatch program.

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

Pfizer is voluntarily recalling some antihypertensive medications because of unacceptable levels of a potential carcinogen, the company announced. 

The affected products are quinapril HCI/hydrochlorothiazide (Accuretic) tablets that Pfizer distributes, and two authorized generics, quinapril plus hydrochlorothiazide and quinapril HCI/hydrochlorothiazide, distributed by Greenstone. The drugs have been withdrawn because of the presence of nitrosamine, N-nitroso-quinapril.

“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” Pfizer said in a news release.

The tablets are indicated for the treatment of hypertension. Patients currently taking the products are asked to consult with their doctor about alternative treatment options.

To date, there have been no reports of adverse events related to the recall, the company said.

In all, Pfizer is recalling six lots of Accuretic tablets (two at 10 mg/12.5 mg, three at 20 mg/12.5 mg, and one at 20 mg/25 mg), one lot of quinapril plus hydrochlorothiazide 20-mg/25-mg tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets (three at 20 mg/12.5 mg and one at 20 mg/25 mg)

The recalled tablets were sold in 90-count bottles distributed in the United States and Puerto Rico between November 2019 and March 2022. Product codes and lot numbers of the recalled medications are listed on the Pfizer website.

Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product. Those with the affected tablets should contact claims management firm Sedgwick by phone at 888-843-0247 Monday through Friday from 8 a.m. to 5 p.m. ET for instructions on how to return their product and obtain reimbursement.

Health care providers with medical questions regarding the recall can contact Pfizer by telephone at 800-438-1985, option 3, Monday through Friday 8 a.m. to 9 p.m. ET.

Providers should report adverse reactions or quality problems they experience using these tablets to Pfizer either by telephone at 800-438-1985, option 1, by regular mail or by fax, or to the Food and Drug Administration’s MedWatch program.

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

Antibiotics are among the most commonly prescribed medications in both outpatient and hospital settings. Global efforts at curbing antibiotic-resistant strains have prompted clinicians to pursue better stewardship, whereby they limit their prescribing of such medications to those who truly need them.

Yet there’s another possible means of addressing antibiotic resistance – using dietary interventions to reduce the gastrointestinal complaints that so often accompany the use of antibiotics: vomiting, nausea, diarrhea, bloating/indigestion, abdominal pain, and loss of appetite. Far from being a mere nuisance, these complications can have major ramifications.

“Often [these side effects] will result in people stopping an antibiotic they need or taking a second- or third-generation one, which potentially causes even more problems with resistance,” explained Daniel J. Merenstein, MD, a professor of family medicine at Georgetown University, Washington, who has conducted multiple trials on antibiotic stewardship and probiotics.

And it’s not just clinicians who would like to find a way around these common complaints. On lifestyle blogs such as Livestrong and Goop, medical news websites, and via academic institutions, patients can learn how the right probiotic supplement or certain fermented or high-fiber foods, for example, might spare them the upset stomach that often accompanies a course of antibiotics.

Yet according to experts in the field, there are notable questions to be answered about whether there’s evidence to support this approach.

The cost of GI discomfort

Pinpointing the exact manner by which antibiotics upend GI tracts is a complex task, according to Gail Cresci, PhD, RD, a microbiome researcher in the department of pediatric gastroenterology, hepatology, and nutrition and director of nutrition research at the Cleveland Clinic.

“A lot of different mechanisms can go awry,” Dr. Cresci said. “But normally, the good microbes are there to help keep the balance, so when that balance is gone, the pathogens can take over and lead to this disruption.”

According to Lynne V. McFarland, PhD, a recently retired infectious disease epidemiologist who now serves as a private consultant, such complications can have substantial ramifications for patients and health care systems.

“If you’re an inpatient and develop antibiotic-associated diarrhea, it usually increases the length of stay from 8 to 20 days. It also increases the cost of care. And small children who have this can get severely dehydrated, which can become life threatening.”

Proponents of probiotics

Several of the researchers who were interviewed believe there’s convincing evidence supporting probiotics for the treatment of common antibiotic-related GI complaints. In many instances, they were involved in the studies themselves.

During Dr. McFarland’s 4-decade career in probiotics research, she has participated in early animal studies with strains such as Saccharomyces boulardii and was involved in meta-analyses of their role in Clostridioides difficile infection and associated diarrhea and even as a potential GI intervention for COVID-19 patients (Antibiotics (Basel). 2021 Apr 9;10(4):408).

In mouse model studies from 2013 and 2018, Dr. Cresci and colleagues showed that the probiotic strains Lactobacillus GG and Faecalibacterium prausnitzii reduced the structural gut changes that lead to antibiotic-associated diarrhea and minimized the risk of C. difficile infection.

In a 2021 randomized controlled trial led by Merenstein, healthy participants were given a trial of amoxicillin/clavulanate (days 1-7) in conjunction with either yogurt containing the probiotic Bifidobacterium animalis subsp lactis BB-12 or control yogurt (days 1-14). After assessing feces samples over a 30-day period, they found that those who received the probiotic yogurt had a significantly smaller decrease in short-chain fatty acid levels and a more stable taxonomic microbiota profile than control persons.

Dr. Merenstein said that, on the basis of results such as these and others, he’s comfortable being relatively definitive about the value of probiotics.

“I believe it’s close to standard of care that if you’re prescribing antibiotics, especially for more than 7 days, you really need to put people on probiotics that have been studied, simply because the evidence is robust enough now,” he said.

Even for proponents, there are caveats

However, all the researchers recommending the use of probiotics did so with caveats. First and foremost, they advise clinicians that the term “probiotics” is an imprecise catchall and is essentially meaningless.

“A lot of products label themselves as probiotic. It’s a great marketing scheme, but many of the products out there aren’t really probiotics; they’re not proven with randomized control trials and don’t have the scientific background,” said Dr. McFarland. “We’ve found that the efficacy is extremely strain specific and disease specific. A strain may work for one disease and not work for another.”

In 2018, Dr. McFarland coauthored an evidence-based practical guide to help clinicians and patients identify the specific strain that works in certain indications. Dr. Cresci recommends that clinicians consult websites such as Probiotics.org or the National Institutes of Health’s database to find the strains that have been proven to work in well-designed clinical trials.

There was also agreement that, to date, the most robust data support probiotics for the treatment of antibiotic-associated diarrhea.

Although the optimal timing of probiotics is a subject of debate, most proponents agreed that the general rule is “the sooner the better.”

Dr. McFarland recommended incorporating probiotics within 24 hours of starting an antibiotic “because the damage done to your GI tract microbiome is pretty quick, and the probiotics work best if they’re established before major disruption occurs.” She added that patients should continue taking probiotics for 2-8 weeks after stopping antibiotics.

“It takes a long time for your normal flora to get restored,” she said. “It’s best to cover your bases.”

For others, the evidence is not definitive

Opinions on the value of probiotics to combat antibiotic-related GI side effects are divergent, though.

“I would not recommend the routine use of probiotics, and certainly not in the prevention of C. difficile or antibiotic-related diarrhea,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk. “I think the evidence does not support that, and I stand strongly on that recommendation.”

Dr. Johnson cited the 2020 guidelines from the American Gastroenterological Association, which offer only a conditional recommendation for the use of specific probiotics and only in preventing antibiotic-associated C. difficile infection.

Geoffrey A. Preidis, MD, PhD, an assistant professor of pediatrics in the section of gastroenterology, hepatology, and nutrition at Baylor College of Medicine, Houston, served as a coauthor of the AGA’s guidelines. He noted that after reviewing 39 published trials of approximately 10,000 patients given probiotics while receiving antibiotics, the authors “did find some evidence that specific probiotics might decrease the risk of C. difficile diarrhea, but the quality of that evidence was low.”

Dr. Preidis attributed this to the lack of well-designed multicenter trials that can isolate the effects of certain strains and determine their benefit in this application.

“The majority of published trials have not reported safety data as rigorously as these data are reported in pharmaceutical trials, so the risk of side effects could be higher than we think,” said Dr. Preidis. “As living microbes, probiotics can move from the intestines into the bloodstream, causing sepsis. Contamination in the manufacturing process has been reported. There might be other long-term effects that we are not yet aware of.”

When asked to characterize the available data on probiotics, Dr. Johnson replied, “I’d generally label it, ‘caveat emptor.’ ”

Dr. McFarland agreed that the field would benefit from better-designed studies and called out meta-analyses that pool outcomes with various strains for particular criticism.

“When researchers do that, it’s no longer valid and shouldn’t have been published, in my opinion,” she told this news organization.

‘Antibiotic diets’ as a possible approach

A compromise between the two sides may be the so-called antibiotic diet. The theory behind such diets is that foods and beverages with biome-boosting properties may be a risk-free intervention that patients can adopt to alleviate antibiotic-related side effects.

“You want your diet to include more soluble fibers to help support the good bacteria, particularly when you’re taking antibiotics,” said Dr. Cresci. “You can get this through eating fresh fruits and vegetables, whole grains, and foods that have more prebiotic, like potatoes. You can also eat fermented food, such as kefir, kombucha, kimchi, and yogurt, so you’re adding more beneficial bacteria into your intestinal tract.”

There is ample published evidence that such foods can boost microbiome diversity and decrease inflammation, including a July 2021 study in Cell. However, the protection this may confer while taking antibiotics isn’t known. Establishing a clear role for the efficacy of such interventions is made additionally difficult by the well-established limitations of conducting dietary clinical trials.

Dr. Merenstein said that there is no compelling evidence that antibiotic-related complications can be offset by changing what goes onto our dinner plates. He joked: “We can’t say, ‘Here’s amoxicillin for your ear infection, now make sure you increase your fermented food, fiber, and water.’ ”

Dr. Johnson said he’s intrigued by studies of prebiotics – fibers that boost beneficial bacteria in the GI system.

“I would love to have more findings about prebiotic identification; that is, things we could do in a healthy way to keep the gut balanced while it’s subject to a change with antibiotics,” he said. “We’re just not there yet.”

Dr. Johnson added that he generally recommends that patients taking antibiotics eat “a bland diet, avoiding things that may have been provocative in the past.”

If patients are already enjoying foods with microbiome-boosting reputations, Dr. Johnson sees “very little downside to continuing that [while on antibiotics].” However, he noted that the period in which you’re taking antibiotics isn’t ideal for trying new foods, given the lack of experience with how the gut bacteria will react.

There are data about foods to avoid while taking antibiotics, which generally fall in line with common dietary knowledge. Many patients may know not to drink grapefruit juice with certain medications, but it’s worth a reminder. Certain antibiotics may also require delaying or avoiding dairy products, although this does not apply to yogurt.

A fiber-deficient diet can aggravate microbiota collapse following antibiotics. In a 2020 study, researchers showed that people on a high-fat diet who were using antibiotics were 8.6 times more likely to have preinflammatory bowel disease than those eating low-fat foods and who had no recent history of antibiotic use. Mouse model data from the same study indicated that poor diet and antibiotics may have worked in conjunction to reduce oxygen in the gut.

Dr. McFarland noted that building a healthy microbiome is a lifelong pursuit and that several factors (for example, environmental or genetic) are out of individuals’ hands. The general public might want a quick fix – ironically, one of the main drivers behind their requesting and receiving antibiotics when they’re not indicated – but it’s likely not available to them.

“You can’t eat one salad and suddenly have a healthy gut, unfortunately.”

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

Antibiotics are among the most commonly prescribed medications in both outpatient and hospital settings. Global efforts at curbing antibiotic-resistant strains have prompted clinicians to pursue better stewardship, whereby they limit their prescribing of such medications to those who truly need them.

Yet there’s another possible means of addressing antibiotic resistance – using dietary interventions to reduce the gastrointestinal complaints that so often accompany the use of antibiotics: vomiting, nausea, diarrhea, bloating/indigestion, abdominal pain, and loss of appetite. Far from being a mere nuisance, these complications can have major ramifications.

“Often [these side effects] will result in people stopping an antibiotic they need or taking a second- or third-generation one, which potentially causes even more problems with resistance,” explained Daniel J. Merenstein, MD, a professor of family medicine at Georgetown University, Washington, who has conducted multiple trials on antibiotic stewardship and probiotics.

And it’s not just clinicians who would like to find a way around these common complaints. On lifestyle blogs such as Livestrong and Goop, medical news websites, and via academic institutions, patients can learn how the right probiotic supplement or certain fermented or high-fiber foods, for example, might spare them the upset stomach that often accompanies a course of antibiotics.

Yet according to experts in the field, there are notable questions to be answered about whether there’s evidence to support this approach.

The cost of GI discomfort

Pinpointing the exact manner by which antibiotics upend GI tracts is a complex task, according to Gail Cresci, PhD, RD, a microbiome researcher in the department of pediatric gastroenterology, hepatology, and nutrition and director of nutrition research at the Cleveland Clinic.

“A lot of different mechanisms can go awry,” Dr. Cresci said. “But normally, the good microbes are there to help keep the balance, so when that balance is gone, the pathogens can take over and lead to this disruption.”

According to Lynne V. McFarland, PhD, a recently retired infectious disease epidemiologist who now serves as a private consultant, such complications can have substantial ramifications for patients and health care systems.

“If you’re an inpatient and develop antibiotic-associated diarrhea, it usually increases the length of stay from 8 to 20 days. It also increases the cost of care. And small children who have this can get severely dehydrated, which can become life threatening.”

Proponents of probiotics

Several of the researchers who were interviewed believe there’s convincing evidence supporting probiotics for the treatment of common antibiotic-related GI complaints. In many instances, they were involved in the studies themselves.

During Dr. McFarland’s 4-decade career in probiotics research, she has participated in early animal studies with strains such as Saccharomyces boulardii and was involved in meta-analyses of their role in Clostridioides difficile infection and associated diarrhea and even as a potential GI intervention for COVID-19 patients (Antibiotics (Basel). 2021 Apr 9;10(4):408).

In mouse model studies from 2013 and 2018, Dr. Cresci and colleagues showed that the probiotic strains Lactobacillus GG and Faecalibacterium prausnitzii reduced the structural gut changes that lead to antibiotic-associated diarrhea and minimized the risk of C. difficile infection.

In a 2021 randomized controlled trial led by Merenstein, healthy participants were given a trial of amoxicillin/clavulanate (days 1-7) in conjunction with either yogurt containing the probiotic Bifidobacterium animalis subsp lactis BB-12 or control yogurt (days 1-14). After assessing feces samples over a 30-day period, they found that those who received the probiotic yogurt had a significantly smaller decrease in short-chain fatty acid levels and a more stable taxonomic microbiota profile than control persons.

Dr. Merenstein said that, on the basis of results such as these and others, he’s comfortable being relatively definitive about the value of probiotics.

“I believe it’s close to standard of care that if you’re prescribing antibiotics, especially for more than 7 days, you really need to put people on probiotics that have been studied, simply because the evidence is robust enough now,” he said.

Even for proponents, there are caveats

However, all the researchers recommending the use of probiotics did so with caveats. First and foremost, they advise clinicians that the term “probiotics” is an imprecise catchall and is essentially meaningless.

“A lot of products label themselves as probiotic. It’s a great marketing scheme, but many of the products out there aren’t really probiotics; they’re not proven with randomized control trials and don’t have the scientific background,” said Dr. McFarland. “We’ve found that the efficacy is extremely strain specific and disease specific. A strain may work for one disease and not work for another.”

In 2018, Dr. McFarland coauthored an evidence-based practical guide to help clinicians and patients identify the specific strain that works in certain indications. Dr. Cresci recommends that clinicians consult websites such as Probiotics.org or the National Institutes of Health’s database to find the strains that have been proven to work in well-designed clinical trials.

There was also agreement that, to date, the most robust data support probiotics for the treatment of antibiotic-associated diarrhea.

Although the optimal timing of probiotics is a subject of debate, most proponents agreed that the general rule is “the sooner the better.”

Dr. McFarland recommended incorporating probiotics within 24 hours of starting an antibiotic “because the damage done to your GI tract microbiome is pretty quick, and the probiotics work best if they’re established before major disruption occurs.” She added that patients should continue taking probiotics for 2-8 weeks after stopping antibiotics.

“It takes a long time for your normal flora to get restored,” she said. “It’s best to cover your bases.”

For others, the evidence is not definitive

Opinions on the value of probiotics to combat antibiotic-related GI side effects are divergent, though.

“I would not recommend the routine use of probiotics, and certainly not in the prevention of C. difficile or antibiotic-related diarrhea,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk. “I think the evidence does not support that, and I stand strongly on that recommendation.”

Dr. Johnson cited the 2020 guidelines from the American Gastroenterological Association, which offer only a conditional recommendation for the use of specific probiotics and only in preventing antibiotic-associated C. difficile infection.

Geoffrey A. Preidis, MD, PhD, an assistant professor of pediatrics in the section of gastroenterology, hepatology, and nutrition at Baylor College of Medicine, Houston, served as a coauthor of the AGA’s guidelines. He noted that after reviewing 39 published trials of approximately 10,000 patients given probiotics while receiving antibiotics, the authors “did find some evidence that specific probiotics might decrease the risk of C. difficile diarrhea, but the quality of that evidence was low.”

Dr. Preidis attributed this to the lack of well-designed multicenter trials that can isolate the effects of certain strains and determine their benefit in this application.

“The majority of published trials have not reported safety data as rigorously as these data are reported in pharmaceutical trials, so the risk of side effects could be higher than we think,” said Dr. Preidis. “As living microbes, probiotics can move from the intestines into the bloodstream, causing sepsis. Contamination in the manufacturing process has been reported. There might be other long-term effects that we are not yet aware of.”

When asked to characterize the available data on probiotics, Dr. Johnson replied, “I’d generally label it, ‘caveat emptor.’ ”

Dr. McFarland agreed that the field would benefit from better-designed studies and called out meta-analyses that pool outcomes with various strains for particular criticism.

“When researchers do that, it’s no longer valid and shouldn’t have been published, in my opinion,” she told this news organization.

‘Antibiotic diets’ as a possible approach

A compromise between the two sides may be the so-called antibiotic diet. The theory behind such diets is that foods and beverages with biome-boosting properties may be a risk-free intervention that patients can adopt to alleviate antibiotic-related side effects.

“You want your diet to include more soluble fibers to help support the good bacteria, particularly when you’re taking antibiotics,” said Dr. Cresci. “You can get this through eating fresh fruits and vegetables, whole grains, and foods that have more prebiotic, like potatoes. You can also eat fermented food, such as kefir, kombucha, kimchi, and yogurt, so you’re adding more beneficial bacteria into your intestinal tract.”

There is ample published evidence that such foods can boost microbiome diversity and decrease inflammation, including a July 2021 study in Cell. However, the protection this may confer while taking antibiotics isn’t known. Establishing a clear role for the efficacy of such interventions is made additionally difficult by the well-established limitations of conducting dietary clinical trials.

Dr. Merenstein said that there is no compelling evidence that antibiotic-related complications can be offset by changing what goes onto our dinner plates. He joked: “We can’t say, ‘Here’s amoxicillin for your ear infection, now make sure you increase your fermented food, fiber, and water.’ ”

Dr. Johnson said he’s intrigued by studies of prebiotics – fibers that boost beneficial bacteria in the GI system.

“I would love to have more findings about prebiotic identification; that is, things we could do in a healthy way to keep the gut balanced while it’s subject to a change with antibiotics,” he said. “We’re just not there yet.”

Dr. Johnson added that he generally recommends that patients taking antibiotics eat “a bland diet, avoiding things that may have been provocative in the past.”

If patients are already enjoying foods with microbiome-boosting reputations, Dr. Johnson sees “very little downside to continuing that [while on antibiotics].” However, he noted that the period in which you’re taking antibiotics isn’t ideal for trying new foods, given the lack of experience with how the gut bacteria will react.

There are data about foods to avoid while taking antibiotics, which generally fall in line with common dietary knowledge. Many patients may know not to drink grapefruit juice with certain medications, but it’s worth a reminder. Certain antibiotics may also require delaying or avoiding dairy products, although this does not apply to yogurt.

A fiber-deficient diet can aggravate microbiota collapse following antibiotics. In a 2020 study, researchers showed that people on a high-fat diet who were using antibiotics were 8.6 times more likely to have preinflammatory bowel disease than those eating low-fat foods and who had no recent history of antibiotic use. Mouse model data from the same study indicated that poor diet and antibiotics may have worked in conjunction to reduce oxygen in the gut.

Dr. McFarland noted that building a healthy microbiome is a lifelong pursuit and that several factors (for example, environmental or genetic) are out of individuals’ hands. The general public might want a quick fix – ironically, one of the main drivers behind their requesting and receiving antibiotics when they’re not indicated – but it’s likely not available to them.

“You can’t eat one salad and suddenly have a healthy gut, unfortunately.”

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

Antibiotics are among the most commonly prescribed medications in both outpatient and hospital settings. Global efforts at curbing antibiotic-resistant strains have prompted clinicians to pursue better stewardship, whereby they limit their prescribing of such medications to those who truly need them.

Yet there’s another possible means of addressing antibiotic resistance – using dietary interventions to reduce the gastrointestinal complaints that so often accompany the use of antibiotics: vomiting, nausea, diarrhea, bloating/indigestion, abdominal pain, and loss of appetite. Far from being a mere nuisance, these complications can have major ramifications.

“Often [these side effects] will result in people stopping an antibiotic they need or taking a second- or third-generation one, which potentially causes even more problems with resistance,” explained Daniel J. Merenstein, MD, a professor of family medicine at Georgetown University, Washington, who has conducted multiple trials on antibiotic stewardship and probiotics.

And it’s not just clinicians who would like to find a way around these common complaints. On lifestyle blogs such as Livestrong and Goop, medical news websites, and via academic institutions, patients can learn how the right probiotic supplement or certain fermented or high-fiber foods, for example, might spare them the upset stomach that often accompanies a course of antibiotics.

Yet according to experts in the field, there are notable questions to be answered about whether there’s evidence to support this approach.

The cost of GI discomfort

Pinpointing the exact manner by which antibiotics upend GI tracts is a complex task, according to Gail Cresci, PhD, RD, a microbiome researcher in the department of pediatric gastroenterology, hepatology, and nutrition and director of nutrition research at the Cleveland Clinic.

“A lot of different mechanisms can go awry,” Dr. Cresci said. “But normally, the good microbes are there to help keep the balance, so when that balance is gone, the pathogens can take over and lead to this disruption.”

According to Lynne V. McFarland, PhD, a recently retired infectious disease epidemiologist who now serves as a private consultant, such complications can have substantial ramifications for patients and health care systems.

“If you’re an inpatient and develop antibiotic-associated diarrhea, it usually increases the length of stay from 8 to 20 days. It also increases the cost of care. And small children who have this can get severely dehydrated, which can become life threatening.”

Proponents of probiotics

Several of the researchers who were interviewed believe there’s convincing evidence supporting probiotics for the treatment of common antibiotic-related GI complaints. In many instances, they were involved in the studies themselves.

During Dr. McFarland’s 4-decade career in probiotics research, she has participated in early animal studies with strains such as Saccharomyces boulardii and was involved in meta-analyses of their role in Clostridioides difficile infection and associated diarrhea and even as a potential GI intervention for COVID-19 patients (Antibiotics (Basel). 2021 Apr 9;10(4):408).

In mouse model studies from 2013 and 2018, Dr. Cresci and colleagues showed that the probiotic strains Lactobacillus GG and Faecalibacterium prausnitzii reduced the structural gut changes that lead to antibiotic-associated diarrhea and minimized the risk of C. difficile infection.

In a 2021 randomized controlled trial led by Merenstein, healthy participants were given a trial of amoxicillin/clavulanate (days 1-7) in conjunction with either yogurt containing the probiotic Bifidobacterium animalis subsp lactis BB-12 or control yogurt (days 1-14). After assessing feces samples over a 30-day period, they found that those who received the probiotic yogurt had a significantly smaller decrease in short-chain fatty acid levels and a more stable taxonomic microbiota profile than control persons.

Dr. Merenstein said that, on the basis of results such as these and others, he’s comfortable being relatively definitive about the value of probiotics.

“I believe it’s close to standard of care that if you’re prescribing antibiotics, especially for more than 7 days, you really need to put people on probiotics that have been studied, simply because the evidence is robust enough now,” he said.

Even for proponents, there are caveats

However, all the researchers recommending the use of probiotics did so with caveats. First and foremost, they advise clinicians that the term “probiotics” is an imprecise catchall and is essentially meaningless.

“A lot of products label themselves as probiotic. It’s a great marketing scheme, but many of the products out there aren’t really probiotics; they’re not proven with randomized control trials and don’t have the scientific background,” said Dr. McFarland. “We’ve found that the efficacy is extremely strain specific and disease specific. A strain may work for one disease and not work for another.”

In 2018, Dr. McFarland coauthored an evidence-based practical guide to help clinicians and patients identify the specific strain that works in certain indications. Dr. Cresci recommends that clinicians consult websites such as Probiotics.org or the National Institutes of Health’s database to find the strains that have been proven to work in well-designed clinical trials.

There was also agreement that, to date, the most robust data support probiotics for the treatment of antibiotic-associated diarrhea.

Although the optimal timing of probiotics is a subject of debate, most proponents agreed that the general rule is “the sooner the better.”

Dr. McFarland recommended incorporating probiotics within 24 hours of starting an antibiotic “because the damage done to your GI tract microbiome is pretty quick, and the probiotics work best if they’re established before major disruption occurs.” She added that patients should continue taking probiotics for 2-8 weeks after stopping antibiotics.

“It takes a long time for your normal flora to get restored,” she said. “It’s best to cover your bases.”

For others, the evidence is not definitive

Opinions on the value of probiotics to combat antibiotic-related GI side effects are divergent, though.

“I would not recommend the routine use of probiotics, and certainly not in the prevention of C. difficile or antibiotic-related diarrhea,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk. “I think the evidence does not support that, and I stand strongly on that recommendation.”

Dr. Johnson cited the 2020 guidelines from the American Gastroenterological Association, which offer only a conditional recommendation for the use of specific probiotics and only in preventing antibiotic-associated C. difficile infection.

Geoffrey A. Preidis, MD, PhD, an assistant professor of pediatrics in the section of gastroenterology, hepatology, and nutrition at Baylor College of Medicine, Houston, served as a coauthor of the AGA’s guidelines. He noted that after reviewing 39 published trials of approximately 10,000 patients given probiotics while receiving antibiotics, the authors “did find some evidence that specific probiotics might decrease the risk of C. difficile diarrhea, but the quality of that evidence was low.”

Dr. Preidis attributed this to the lack of well-designed multicenter trials that can isolate the effects of certain strains and determine their benefit in this application.

“The majority of published trials have not reported safety data as rigorously as these data are reported in pharmaceutical trials, so the risk of side effects could be higher than we think,” said Dr. Preidis. “As living microbes, probiotics can move from the intestines into the bloodstream, causing sepsis. Contamination in the manufacturing process has been reported. There might be other long-term effects that we are not yet aware of.”

When asked to characterize the available data on probiotics, Dr. Johnson replied, “I’d generally label it, ‘caveat emptor.’ ”

Dr. McFarland agreed that the field would benefit from better-designed studies and called out meta-analyses that pool outcomes with various strains for particular criticism.

“When researchers do that, it’s no longer valid and shouldn’t have been published, in my opinion,” she told this news organization.

‘Antibiotic diets’ as a possible approach

A compromise between the two sides may be the so-called antibiotic diet. The theory behind such diets is that foods and beverages with biome-boosting properties may be a risk-free intervention that patients can adopt to alleviate antibiotic-related side effects.

“You want your diet to include more soluble fibers to help support the good bacteria, particularly when you’re taking antibiotics,” said Dr. Cresci. “You can get this through eating fresh fruits and vegetables, whole grains, and foods that have more prebiotic, like potatoes. You can also eat fermented food, such as kefir, kombucha, kimchi, and yogurt, so you’re adding more beneficial bacteria into your intestinal tract.”

There is ample published evidence that such foods can boost microbiome diversity and decrease inflammation, including a July 2021 study in Cell. However, the protection this may confer while taking antibiotics isn’t known. Establishing a clear role for the efficacy of such interventions is made additionally difficult by the well-established limitations of conducting dietary clinical trials.

Dr. Merenstein said that there is no compelling evidence that antibiotic-related complications can be offset by changing what goes onto our dinner plates. He joked: “We can’t say, ‘Here’s amoxicillin for your ear infection, now make sure you increase your fermented food, fiber, and water.’ ”

Dr. Johnson said he’s intrigued by studies of prebiotics – fibers that boost beneficial bacteria in the GI system.

“I would love to have more findings about prebiotic identification; that is, things we could do in a healthy way to keep the gut balanced while it’s subject to a change with antibiotics,” he said. “We’re just not there yet.”

Dr. Johnson added that he generally recommends that patients taking antibiotics eat “a bland diet, avoiding things that may have been provocative in the past.”

If patients are already enjoying foods with microbiome-boosting reputations, Dr. Johnson sees “very little downside to continuing that [while on antibiotics].” However, he noted that the period in which you’re taking antibiotics isn’t ideal for trying new foods, given the lack of experience with how the gut bacteria will react.

There are data about foods to avoid while taking antibiotics, which generally fall in line with common dietary knowledge. Many patients may know not to drink grapefruit juice with certain medications, but it’s worth a reminder. Certain antibiotics may also require delaying or avoiding dairy products, although this does not apply to yogurt.

A fiber-deficient diet can aggravate microbiota collapse following antibiotics. In a 2020 study, researchers showed that people on a high-fat diet who were using antibiotics were 8.6 times more likely to have preinflammatory bowel disease than those eating low-fat foods and who had no recent history of antibiotic use. Mouse model data from the same study indicated that poor diet and antibiotics may have worked in conjunction to reduce oxygen in the gut.

Dr. McFarland noted that building a healthy microbiome is a lifelong pursuit and that several factors (for example, environmental or genetic) are out of individuals’ hands. The general public might want a quick fix – ironically, one of the main drivers behind their requesting and receiving antibiotics when they’re not indicated – but it’s likely not available to them.

“You can’t eat one salad and suddenly have a healthy gut, unfortunately.”

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

The World Health Organization now recommends shortened treatment for children with mild tuberculosis, as well as two oral TB treatments (bedaquiline and delamanid) for use in children of all ages. The updated guidelines for TB management in children and adolescents were announced March 21 ahead of World Tuberculosis Day on March 24.

The agency also called for increased investment in global TB programs, noting that in 2020, TB deaths increased for the first time in over a decade. “We cannot falter in our commitment to reach and save every man, woman, child, family, and community impacted by this deadly disease,” said Tereza Kasaeva, MD, PhD, director of the WHO Global Tuberculosis Programme during a press conference.

TB is the 13th-leading cause of death and the second top infectious killer after COVID-19, with more than 4,100 people dying from TB every day. WHO estimates that 1.1 million children fall ill with TB each year.
 

Calls for investment

The increase in TB deaths from 1.4 million in 2019 to 1.5 million in 2020 was coupled with a decrease in funding. From 2019-2020, global spending for TB diagnostic, treatment, and prevention services fell from $5.8 billion to $5.3 billion. This is less than half of the $13 billion target funding amount for 2022, Dr. Kasaeva said.

Efforts to expand access to TB care have fallen short mainly because of this lack of funding, especially for children. In 2020, about 63% of children under 15 years of age with TB either did not receive or were not reported to have access to TB diagnosis and treatment services, which rose to 72% in children under age 5. Almost two-thirds of children under age 5 also did not receive TB preventive treatment in 2022, according to WHO statistics.

The socioeconomic ramifications of the COVID-19 pandemic as well as ongoing conflict in Eastern Europe, Africa, and the Middle East have “further exacerbated the situation,” Dr. Kasaeva said. “This conveys the urgent need to dramatically increase investments to ramp up the fight against TB and achieve commitments to end TB made by global leaders.”

Dr. Kasaeva laid out WHO’s main points for global investment in TB care:

• Increase domestic and international funding to close gaps in TB research and program implementation. For countries with smaller economies, increased international investment will be necessary in the short or medium term to help regain progress.
• Double funding for TB research, including vaccines.
• Invest in sustaining TB programs and services during the COVID-19 pandemic and ongoing crises so care is not disrupted.

New guidelines

Dr. Kasaeva also noted that adoption of WHO’s new guidelines for children and adolescents should be fast-tracked to improve access to and quality of care. The updates include:

• Rapid molecular tests called Xpert Ultra should be used as the initial test for TB in children and adolescents.
• Diagnostic testing can now include noninvasive specimens, like stool samples.
• Children with mild TB can be treated with a , rather than 6 months. This shortened regimen will allow children to return to school faster and save money for families and the health care system, said Kerri Viney, MD, PhD, a team lead for the WHO Tuberculosis Programme, with a focus on vulnerable populations, including children. She presented the new guidelines during the WHO press conference.
• The recommended treatment regimen for TB meningitis has also been shortened from 12 to 6 months.

Two oral medications for drug-resistant TB (bedaquiline and delamanid) are now recommended for use in children of all ages. “There is no longer a need for painful injections that can have serious side effects, including deafness,” Dr. Viney said.

Health systems should develop new models of decentralized and integrated TB care to bring TB care closer to where children live.

The guidelines are available on the WHO website.

“The WHO guidelines issued today are a game changer for children and adolescents with TB,” Dr. Kasaeva said. The next step is assisting countries in implementing these updates so that children and adolescents globally have access to high quality TB care,” Dr. Viney added. “We have the policy recommendations. We have the implementation guidance, we have child-friendly formulations of TB medicines,” she said. “Let us not wait any longer. Let us invest to end TB in children and adolescents.”

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

The World Health Organization now recommends shortened treatment for children with mild tuberculosis, as well as two oral TB treatments (bedaquiline and delamanid) for use in children of all ages. The updated guidelines for TB management in children and adolescents were announced March 21 ahead of World Tuberculosis Day on March 24.

The agency also called for increased investment in global TB programs, noting that in 2020, TB deaths increased for the first time in over a decade. “We cannot falter in our commitment to reach and save every man, woman, child, family, and community impacted by this deadly disease,” said Tereza Kasaeva, MD, PhD, director of the WHO Global Tuberculosis Programme during a press conference.

TB is the 13th-leading cause of death and the second top infectious killer after COVID-19, with more than 4,100 people dying from TB every day. WHO estimates that 1.1 million children fall ill with TB each year.
 

Calls for investment

The increase in TB deaths from 1.4 million in 2019 to 1.5 million in 2020 was coupled with a decrease in funding. From 2019-2020, global spending for TB diagnostic, treatment, and prevention services fell from $5.8 billion to $5.3 billion. This is less than half of the $13 billion target funding amount for 2022, Dr. Kasaeva said.

Efforts to expand access to TB care have fallen short mainly because of this lack of funding, especially for children. In 2020, about 63% of children under 15 years of age with TB either did not receive or were not reported to have access to TB diagnosis and treatment services, which rose to 72% in children under age 5. Almost two-thirds of children under age 5 also did not receive TB preventive treatment in 2022, according to WHO statistics.

The socioeconomic ramifications of the COVID-19 pandemic as well as ongoing conflict in Eastern Europe, Africa, and the Middle East have “further exacerbated the situation,” Dr. Kasaeva said. “This conveys the urgent need to dramatically increase investments to ramp up the fight against TB and achieve commitments to end TB made by global leaders.”

Dr. Kasaeva laid out WHO’s main points for global investment in TB care:

• Increase domestic and international funding to close gaps in TB research and program implementation. For countries with smaller economies, increased international investment will be necessary in the short or medium term to help regain progress.
• Double funding for TB research, including vaccines.
• Invest in sustaining TB programs and services during the COVID-19 pandemic and ongoing crises so care is not disrupted.

New guidelines

Dr. Kasaeva also noted that adoption of WHO’s new guidelines for children and adolescents should be fast-tracked to improve access to and quality of care. The updates include:

• Rapid molecular tests called Xpert Ultra should be used as the initial test for TB in children and adolescents.
• Diagnostic testing can now include noninvasive specimens, like stool samples.
• Children with mild TB can be treated with a , rather than 6 months. This shortened regimen will allow children to return to school faster and save money for families and the health care system, said Kerri Viney, MD, PhD, a team lead for the WHO Tuberculosis Programme, with a focus on vulnerable populations, including children. She presented the new guidelines during the WHO press conference.
• The recommended treatment regimen for TB meningitis has also been shortened from 12 to 6 months.

Two oral medications for drug-resistant TB (bedaquiline and delamanid) are now recommended for use in children of all ages. “There is no longer a need for painful injections that can have serious side effects, including deafness,” Dr. Viney said.

Health systems should develop new models of decentralized and integrated TB care to bring TB care closer to where children live.

The guidelines are available on the WHO website.

“The WHO guidelines issued today are a game changer for children and adolescents with TB,” Dr. Kasaeva said. The next step is assisting countries in implementing these updates so that children and adolescents globally have access to high quality TB care,” Dr. Viney added. “We have the policy recommendations. We have the implementation guidance, we have child-friendly formulations of TB medicines,” she said. “Let us not wait any longer. Let us invest to end TB in children and adolescents.”

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

The World Health Organization now recommends shortened treatment for children with mild tuberculosis, as well as two oral TB treatments (bedaquiline and delamanid) for use in children of all ages. The updated guidelines for TB management in children and adolescents were announced March 21 ahead of World Tuberculosis Day on March 24.

The agency also called for increased investment in global TB programs, noting that in 2020, TB deaths increased for the first time in over a decade. “We cannot falter in our commitment to reach and save every man, woman, child, family, and community impacted by this deadly disease,” said Tereza Kasaeva, MD, PhD, director of the WHO Global Tuberculosis Programme during a press conference.

TB is the 13th-leading cause of death and the second top infectious killer after COVID-19, with more than 4,100 people dying from TB every day. WHO estimates that 1.1 million children fall ill with TB each year.
 

Calls for investment

The increase in TB deaths from 1.4 million in 2019 to 1.5 million in 2020 was coupled with a decrease in funding. From 2019-2020, global spending for TB diagnostic, treatment, and prevention services fell from $5.8 billion to $5.3 billion. This is less than half of the $13 billion target funding amount for 2022, Dr. Kasaeva said.

Efforts to expand access to TB care have fallen short mainly because of this lack of funding, especially for children. In 2020, about 63% of children under 15 years of age with TB either did not receive or were not reported to have access to TB diagnosis and treatment services, which rose to 72% in children under age 5. Almost two-thirds of children under age 5 also did not receive TB preventive treatment in 2022, according to WHO statistics.

The socioeconomic ramifications of the COVID-19 pandemic as well as ongoing conflict in Eastern Europe, Africa, and the Middle East have “further exacerbated the situation,” Dr. Kasaeva said. “This conveys the urgent need to dramatically increase investments to ramp up the fight against TB and achieve commitments to end TB made by global leaders.”

Dr. Kasaeva laid out WHO’s main points for global investment in TB care:

• Increase domestic and international funding to close gaps in TB research and program implementation. For countries with smaller economies, increased international investment will be necessary in the short or medium term to help regain progress.
• Double funding for TB research, including vaccines.
• Invest in sustaining TB programs and services during the COVID-19 pandemic and ongoing crises so care is not disrupted.

New guidelines

Dr. Kasaeva also noted that adoption of WHO’s new guidelines for children and adolescents should be fast-tracked to improve access to and quality of care. The updates include:

• Rapid molecular tests called Xpert Ultra should be used as the initial test for TB in children and adolescents.
• Diagnostic testing can now include noninvasive specimens, like stool samples.
• Children with mild TB can be treated with a , rather than 6 months. This shortened regimen will allow children to return to school faster and save money for families and the health care system, said Kerri Viney, MD, PhD, a team lead for the WHO Tuberculosis Programme, with a focus on vulnerable populations, including children. She presented the new guidelines during the WHO press conference.
• The recommended treatment regimen for TB meningitis has also been shortened from 12 to 6 months.

Two oral medications for drug-resistant TB (bedaquiline and delamanid) are now recommended for use in children of all ages. “There is no longer a need for painful injections that can have serious side effects, including deafness,” Dr. Viney said.

Health systems should develop new models of decentralized and integrated TB care to bring TB care closer to where children live.

The guidelines are available on the WHO website.

“The WHO guidelines issued today are a game changer for children and adolescents with TB,” Dr. Kasaeva said. The next step is assisting countries in implementing these updates so that children and adolescents globally have access to high quality TB care,” Dr. Viney added. “We have the policy recommendations. We have the implementation guidance, we have child-friendly formulations of TB medicines,” she said. “Let us not wait any longer. Let us invest to end TB in children and adolescents.”

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

The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.

Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.

“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.

Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.

“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”

Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.

In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.

“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”

Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.

Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.

“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.

There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.

Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).

The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.

Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.

“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”

He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”

Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.

“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”

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

The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.

Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.

“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.

Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.

“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”

Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.

In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.

“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”

Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.

Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.

“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.

There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.

Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).

The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.

Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.

“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”

He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”

Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.

“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”

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

The pediatric oncology unit in Kyiv’s National Cancer Institute is empty, with all the children evacuated to safer hospitals in Western Ukraine or further, making it a good place to talk on Zoom.

Against a backdrop of colorful animals painted on the wall, Oleksandr Stakhovskyi, MD, PhD, speaks optimistically about the future of his city, his country, and even his patients, despite acknowledging that his surgical hands are now trained to use a machine gun.

“It’s not as bad as last week,” he laughs, explaining that residents of Kyiv are more relaxed now, despite the air raid sirens, because the city’s anti-missile system has thus far kept them safe.

Even still, missiles have continued hitting civilian residences and Dr. Stakhovskyi, a urologic-oncology surgeon, has evacuated his wife and children out of the country, as have 70% of his colleagues. But for those who stayed in Kyiv, there is a strong resolve.

“People working in IT, in law, in other professions — they just took the guns and stayed in Kyiv,” he said in an interview. “They are just civilians, armed, trying to protect and fortify Kyiv — to make it unbreakable.”

Dr. Stakhovskyi doesn’t have a background in the military, but he now knows how to use a machine gun. “I am a super-specialized oncologist, [but] I realize if I leave right now it will give the Russians momentum to come in. The longer it takes, the weaker the opponent army will become, and we are more and more optimistic,” he said.

In Kyiv, Dr. Stakhovskyi is working half the time at the cancer hospital and the other half at the nearby military hospital, but he said so far war casualties are minimal within the city, and even the flow of patients with cancer has reduced.

“I had my surgeries planned up until the end of March, but when the war started, they were all postponed,” he said. Emergency cancer surgeries have continued, and now there is talk of resuming some others. “We will stratify patients into categories based on need,” he said. “For those patients whose surgery can basically stop the disease and they don’t need neoadjuvant chemo, we’ll probably be doing those.”

Medical oncology clinics have also resumed, said Dr. Stakhovskyi, but the volume of patients is low, because many have left the city. An estimated 3.3 million people have left Ukraine since the Russian invasion on February 24.

Across the country, in Lviv near the Polish border, another surgical oncologist tells a different story. Andriy Hrynkiv, MD, from Lviv Regional Cancer Center, says his hospital has seen a dramatic increase in patients, displaced internally from areas where the medical infrastructure has collapsed.

“Russian forces have destroyed more than 117 hospitals, 43 ambulances have been shot at, 6 doctors have been killed, and 13 wounded,” Dr. Hrynkiv said. In the city of Mariupol, “doctors and patients have been taken hostage,” he said, used by Russian forces as a human shield. In Kharkiv, with approximately 1.5 million residents, the only oncologic hospital has been destroyed.

There is a shortage and instability of medical supplies including all iodine-containing medications that citizens are stocking up on in the face of a potential nuclear attack, he said.

Dr. Hrynkiv was speaking on a webcast organized by the American Society of Clinical Oncology (ASCO) and European Cancer Organisation (ECO).

The two organizations are collaborating with each other and the World Health Organization to create a special network that is aiming to connect professionals, academic and clinical centers, and patient groups.

Additionally, the Ukranian Society of Clinical Oncology (USCO), cofounded by Dr. Stakhovskyi, is trying to keep patients connected with nongovernment organizations.

“These patient organizations moved west when the war started, but they still use us to help them make contact with foreign doctors,” he said. “We have tried to centralize this process but it’s very difficult because patients and organizations are also calling doctors and centers directly looking for treatment options.”

He says USCO is also coordinating the distribution of a donation of immunotherapy pembrolizumab (Keytruda) from pharmaceutical company Merck Sharp & Dohme. “It’s a huge influx of this drug,” he says. “They’ve promised something like 2,000 doses to cover 230 patients for 3 months at least. Usually this is not an easy drug to access for people in Ukraine because it’s really expensive.”

Dr. Stakhovskyi said the optimism he feels is fueled by the support that Ukrainians feel from the rest of the world.

“We see the reaction of our international colleagues. It is so impressive and touching — lots of my ex-professors are texting me and sending me messages from all over the place, from Germany, from Canada, from France, from the United States,” he said. “And if we can be optimistic for ourselves, definitely that translates to our patients.”

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

Urologist Arnaldo Trabucco, MD, was outraged when he learned of a legal claim filed by a patient’s family blaming him for the patient’s death.

Dr. Trabucco had performed a successful laparoscopic left radical nephrectomy on Gerald Scharf, but he died 3 days later from an unrelated condition, said Dr. Trabucco, who now practices in California. The claims alleged not only wrongful death, but also that Dr. Trabucco “committed willful and malicious actions upon” the patient, eventually resulting in his death, and that Dr. Trabucco’s actions constituted “extreme and outrageous behavior.”

The accusations were levied on behalf of the patient’s family by a bankruptcy attorney who admittedly had no experience in medical malpractice litigation.

“It was a vicious allegation that I intentionally tried to kill my own patient,” said Dr. Trabucco, 66. “It’s an allegation that was outlandish. Those were fighting words.”

As the case dragged on, Dr. Trabucco filed a complaint against the Scharfs and bankruptcy attorney Jeffrey Cogan for malicious prosecution and abuse of process. In 2018, Dr. Trabucco prevailed when a jury awarded him $6,232,000 in compensatory damages and $1,768,000 in punitive damages against Mr. Cogan. (No damages were assessed against the patient’s family.)

“This was a principle issue more than anything else,” Dr. Trabucco said. “My name was tarnished and thrown through the mud. I’m very proud of my name and my reputation.”

Mr. Cogan, a bankruptcy attorney licensed in Nevada and California, disputes that his actions were malicious and disagrees with the jury’s verdict.

“I don’t think I did anything wrong with filing the lawsuit,” he said.

Despite the $8 million award, the legal fight between Dr. Trabucco and Mr. Cogan has continued – and is not over yet.
 

Not your ordinary legal journey

Dr. Trabucco completed his medical training in Rome before moving back to the United States to begin his residency in Brooklyn, New York.

He quietly practiced urology in New York for years before moving to Columbus, Ind., to work at a urology clinic. In 2005, Dr. Trabucco made headlines when the Bartholomew County, Ind., sheriff’s deputies found marijuana plants growing in his home. His medical license was suspended, and he pled guilty to a misdemeanor.

Dr. Trabucco said he was unaware that a family member was growing the plants in the home and that he was not responsible for the operation. The misdemeanor has since been expunged from his record, according to Dr. Trabucco. Bartholomew County records do not list the offense. He later moved to Arizona, where he opened a medical practice.

Before the Scharfs filed their malpractice case in 2013, Dr. Trabucco had been embroiled in a series of unrelated legal disputes, including postdivorce proceedings and a complaint against him by another physician, alleging defamation. In that case, the physician claimed Dr. Trabucco published false and defamatory communications about him, including that the physician committed intentional fraud.

Dr. Trabucco filed his own suit for defamation and infliction of emotional distress against the same physician for alleged threats and harassment and making false reports about him to several Arizona state entities. The defamation suit against Dr. Trabucco ended in a settlement, the terms of which are confidential, according to Mr. Cogan. Dr. Trabucco’s defamation case against the physician was dismissed, according to court records, but they do not specify the reason. Dr. Trabucco said he dropped the defamation case because of the other relentless litigation he was facing.

In November 2012, Dr. Trabucco filed for Chapter 7 bankruptcy protection.

Mr. Cogan was representing Dr. Trabucco’s ex-wife’s interests as a creditor in the bankruptcy proceeding and eventually represented the physician who sued Dr. Trabucco, according to court documents. In all, Mr. Cogan represented six creditors in connection to Dr. Trabucco’s bankruptcy, including the Scharfs. He also took over the Scharfs’ malpractice case in Arizona’s Mohave County Superior Court after their attorney died.

As part of a filing in Nevada bankruptcy court called a “Complaint to Determine Nondischargeabiliy of Debts,” Mr. Cogan alleged that Dr. Trabucco knew he lacked sufficient expertise regarding the laparoscopic nephrectomy, that an intraoperative complication occurred because of his error, and that Dr. Trabucco hid the complication and did not attempt to remedy the situation, among other claims.

In addition to the Mohave County filing and the bankruptcy filing, Mr. Cogan filed a similar medical malpractice case against Dr. Trabucco in Arizona district court.

“I believe, based upon the statements by [a retired medical malpractice attorney], that Dr Trabucco squeezed the abdominal aorta,” Mr. Cogan said. “When he did so, plaque from Mr Scharf blocked blood from going to his remaining his kidney, causing his death. My lawsuit said that Dr Trabucco knew he made a mistake and went home rather than fixing the mistake.”

Dr. Trabucco said the laparoscopic nephrectomy went smoothly. A few hours after the surgery, however, Mr. Scharf was transferred to a Las Vegas hospital with a diagnosis of potential occlusion of the abdominal aorta. Surgery was performed, and while the operative report noted the presence of severe atherosclerosis of the abdominal aorta, there was no indication of an intraoperative injury to the aorta from Dr. Trabucco’s surgery, according to court documents filed in U.S. District Court for the District of Arizona. An autopsy performed on Mr. Scharf reported “severe calcific aortic atherosclerosis, primarily at the aortic arch and abdominal aorta at the level of the branching of the renal arteries with small adherent thrombus.” The autopsy did not include any indication or suggestion of an intraoperative injury to the abdominal aorta.

A federal jury found unanimously in favor of Dr. Trabucco, concluding that he did nothing wrong. The original medical malpractice case in Mohave County court was ultimately dismissed and in 2014, the bankruptcy court entered an order discharging Dr. Trabucco from all prepetition debts, according to court records.

Meanwhile, as the malicious prosecution case against Mr. Cogan continued, Dr. Trabucco’s name again drew media attention. His former girlfriend was arrested for plotting to kidnap and kill an attorney who was representing Dr. Trabucco’s ex-wife in a divorce proceeding. Renee Perillo was sentenced to 27 years in prison for conspiracy to commit kidnapping and murder for hire for trying to kill Noblesville, Ind., attorney Rebecca Eimerman. Ms. Eimerman was pursuing divorce settlement money from Dr. Trabucco on behalf of his ex-wife. Ms. Perillo’s son was also charged in the crime.

No charges related to the crime were filed against Dr. Trabucco, according to the Hamilton County Prosecutor’s Office and federal charging records. Dr. Trabucco said he was not involved in the incident and had no knowledge of Perillo’s plans.
 

A hard fought – and still continuing – legal battle

After a 3-day trial, jurors in 2018 found that Mr. Cogan owed Dr. Trabucco $8 million for the harm caused by the unfounded claims.

“This has had a tremendous impact on my life,” Dr. Trabucco said. “It’s cost me a lot of time, money, and anguish.”

Mr. Cogan appealed the verdict. An Arizona appeals court in 2020 upheld the finding of liability for malicious prosecution against Mr. Cogan, but it vacated the finding of liability for abuse of process. Because of the partial reversal, the appellate court vacated the $8 million and sent the case back to the Superior Court in Mohave County, Ariz., for a new trial on damages.

But shortly before the December 2021 retrial, both parties agreed to settle for $8 million.

The settlement, however, is not the end of the litigation between the parties.

Late last year, Mr. Cogan filed a new case in the U.S. District Court for the District of Nevada against Dr. Trabucco alleging the Arizona court that tried the malicious prosecution case never had jurisdiction. Mr. Cogan contends that per federal case law, any damages resulting from a bankruptcy court pleading give the federal court exclusive jurisdiction over the matter.

“I believe that I will win the federal court case,” Mr. Cogan said. “If Judge Andrew P. Gordon finds for me, Dr. Trabucco’s judgment in Arizona is void as Arizona did not have subject-matter jurisdiction.”

Dr. Trabucco says the new federal case has no merit.

“The federal courts have no jurisdiction over civil matters, and this should be thrown out,” he said. “However, my attorney is fully prepared to take this to the Supreme Court [if it moves forward].”

At this article’s deadline, the judge had not yet ruled on Dr. Trabucco’s motion to dismiss the federal complaint.
 

Should a physician sue for malicious prosecution?

Dr. Trabucco’s case raises the question of whether physicians should consider suing a patient after winning their malpractice case. As many doctors know, a successful case outcome doesn’t necessarily undo the time spent, income lost, and reputation harm that often comes with a negligence lawsuit. Is suing for malicious prosecution a reasonable route to recoup some of the damages caused by the claim?

“It’s an uphill struggle to prevail,” said Jeffrey Segal, MD, JD. “Have people done it? Yes, they have. Is it easy? No.”

A physician must hit the marks of a distinct checklist to pursue a malicious prosecution case, said Dr. Segal, CEO and founder of Medical Justice, a company that aids and advises physicians on legal matters. One necessary element is that the malpractice case against the physician must have been adjudicated on the merits, he said. For example, the doctor won the case at trial or the case was dismissed on summary judgment. Summary judgment refers to a court tossing the claim because there was no genuine dispute as to any material fact and because the defendant is entitled to judgment as a matter of law.

If the case was dismissed for another reason, such as a technicality, or dropped by the plaintiff, the case would not meet the threshold for a malicious prosecution claim, Dr. Segal explains.

The physician must also show that the lawsuit was instituted with “malice,” meaning with an intent to hurt the physician, and that the lawsuit was brought without “probable cause,” adds J. Richard Moore, JD, a medical malpractice defense attorney based in Indianapolis.

“The courts are still pretty good at weeding out cases with no merit whatsoever, so even if a physician takes a case to trial and wins, it is exceedingly rare that a case that makes it that far, has no merit whatsoever,” Mr. Moore said.

In addition, a plaintiffs’ attorney may be protected from a malicious prosecution claim because they relied on a medical expert’s opinion that reasonable cause existed to file a lawsuit, notes William Sullivan, DO, JD, an emergency physician and attorney based in Frankfort, Ill.

Dr. Sullivan has personal experience with such a challenge. He filed a malicious prosecution claim against a plaintiffs’ attorney after being dismissed from a medical malpractice case. The claim stemmed from Dr. Sullivan inserting an emergency central line into a trauma patient who was taken to surgery and later died. The suit alleged Dr. Sullivan failed to diagnose internal bleeding and failed to perform surgery, although surgeons at the hospital knew internal bleeding was present and Dr. Sullivan had no privileges to perform surgery, he said.

However, Dr. Sullivan was unable to identify the medical expert involved in the claim. Illinois law allows a malpractice plaintiff to withhold the identity of a medical expert who certifies a malpractice lawsuit. Because Dr. Sullivan couldn’t identify the expert, he could not depose the physician, and the law firm claimed there was no malicious prosecution because it relied on the trauma surgeon’s opinion that Dr. Sullivan was liable.

The trial court agreed with the law firm’s argument and dismissed them from the case, Dr. Sullivan said. The trial court also agreed that the expert trauma surgeon should be allowed to remain anonymous in accordance with Illinois law.
 

Alternative options for doctors to recover damages

For physicians who want to recoup after a frivolous claim, but don’t want to dive into another lawsuit, there are other options, say legal experts.

One alternative is filing a motion for sanctions, Dr. Sullivan said. If an attorney files a lawsuit that does not have a reasonable basis in fact or law, that attorney could be subject to sanctions, including paying for the physician’s attorney’s fees and costs, he explained. If a motion for sanctions is granted against an opposing attorney, that fact may be reportable to the attorney’s insurance carrier and also reportable to the attorney’s state licensing board. A motion for sanctions does not require filing of a separate lawsuit and filing a motion for sanctions may allow the defendant physician or the defense attorney to depose the plaintiff attorney regarding the reasonable basis that attorney had for filing a lawsuit, Dr. Sullivan said.

Dr. Sullivan recently represented a physician who won a motion for sanctions. During the legal action against him, Dr. Sullivan presented the plaintiff’s attorney with information showing why his lawsuit did not have a reasonable basis, but the attorney repeatedly ignored the information.

“Eventually, I filed a motion to dismiss the physician from the lawsuit and that motion was granted,” he said. “I also filed a motion for sanctions so that the physician could recover the costs involved in defending the claim. The trial court granted our motion for sanctions against the plaintiff and her law firm and awarded my client more than $10,000.”

Physicians who believe a plaintiffs’ attorney is acting unprofessionally can also file a complaint with the attorney’s bar, Dr. Segal said. And expert witnesses acting in bad faith can be reported to professional societies, medical licensing boards, and/or specialty boards.

“There are a number of avenues to address the sense of justice,” he said. “But if you’re looking for a payday, the only way to do that is by going to court.”

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

Urologist Arnaldo Trabucco, MD, was outraged when he learned of a legal claim filed by a patient’s family blaming him for the patient’s death.

Dr. Trabucco had performed a successful laparoscopic left radical nephrectomy on Gerald Scharf, but he died 3 days later from an unrelated condition, said Dr. Trabucco, who now practices in California. The claims alleged not only wrongful death, but also that Dr. Trabucco “committed willful and malicious actions upon” the patient, eventually resulting in his death, and that Dr. Trabucco’s actions constituted “extreme and outrageous behavior.”

The accusations were levied on behalf of the patient’s family by a bankruptcy attorney who admittedly had no experience in medical malpractice litigation.

“It was a vicious allegation that I intentionally tried to kill my own patient,” said Dr. Trabucco, 66. “It’s an allegation that was outlandish. Those were fighting words.”

As the case dragged on, Dr. Trabucco filed a complaint against the Scharfs and bankruptcy attorney Jeffrey Cogan for malicious prosecution and abuse of process. In 2018, Dr. Trabucco prevailed when a jury awarded him $6,232,000 in compensatory damages and $1,768,000 in punitive damages against Mr. Cogan. (No damages were assessed against the patient’s family.)

“This was a principle issue more than anything else,” Dr. Trabucco said. “My name was tarnished and thrown through the mud. I’m very proud of my name and my reputation.”

Mr. Cogan, a bankruptcy attorney licensed in Nevada and California, disputes that his actions were malicious and disagrees with the jury’s verdict.

“I don’t think I did anything wrong with filing the lawsuit,” he said.

Despite the $8 million award, the legal fight between Dr. Trabucco and Mr. Cogan has continued – and is not over yet.
 

Not your ordinary legal journey

Dr. Trabucco completed his medical training in Rome before moving back to the United States to begin his residency in Brooklyn, New York.

He quietly practiced urology in New York for years before moving to Columbus, Ind., to work at a urology clinic. In 2005, Dr. Trabucco made headlines when the Bartholomew County, Ind., sheriff’s deputies found marijuana plants growing in his home. His medical license was suspended, and he pled guilty to a misdemeanor.

Dr. Trabucco said he was unaware that a family member was growing the plants in the home and that he was not responsible for the operation. The misdemeanor has since been expunged from his record, according to Dr. Trabucco. Bartholomew County records do not list the offense. He later moved to Arizona, where he opened a medical practice.

Before the Scharfs filed their malpractice case in 2013, Dr. Trabucco had been embroiled in a series of unrelated legal disputes, including postdivorce proceedings and a complaint against him by another physician, alleging defamation. In that case, the physician claimed Dr. Trabucco published false and defamatory communications about him, including that the physician committed intentional fraud.

Dr. Trabucco filed his own suit for defamation and infliction of emotional distress against the same physician for alleged threats and harassment and making false reports about him to several Arizona state entities. The defamation suit against Dr. Trabucco ended in a settlement, the terms of which are confidential, according to Mr. Cogan. Dr. Trabucco’s defamation case against the physician was dismissed, according to court records, but they do not specify the reason. Dr. Trabucco said he dropped the defamation case because of the other relentless litigation he was facing.

In November 2012, Dr. Trabucco filed for Chapter 7 bankruptcy protection.

Mr. Cogan was representing Dr. Trabucco’s ex-wife’s interests as a creditor in the bankruptcy proceeding and eventually represented the physician who sued Dr. Trabucco, according to court documents. In all, Mr. Cogan represented six creditors in connection to Dr. Trabucco’s bankruptcy, including the Scharfs. He also took over the Scharfs’ malpractice case in Arizona’s Mohave County Superior Court after their attorney died.

As part of a filing in Nevada bankruptcy court called a “Complaint to Determine Nondischargeabiliy of Debts,” Mr. Cogan alleged that Dr. Trabucco knew he lacked sufficient expertise regarding the laparoscopic nephrectomy, that an intraoperative complication occurred because of his error, and that Dr. Trabucco hid the complication and did not attempt to remedy the situation, among other claims.

In addition to the Mohave County filing and the bankruptcy filing, Mr. Cogan filed a similar medical malpractice case against Dr. Trabucco in Arizona district court.

“I believe, based upon the statements by [a retired medical malpractice attorney], that Dr Trabucco squeezed the abdominal aorta,” Mr. Cogan said. “When he did so, plaque from Mr Scharf blocked blood from going to his remaining his kidney, causing his death. My lawsuit said that Dr Trabucco knew he made a mistake and went home rather than fixing the mistake.”

Dr. Trabucco said the laparoscopic nephrectomy went smoothly. A few hours after the surgery, however, Mr. Scharf was transferred to a Las Vegas hospital with a diagnosis of potential occlusion of the abdominal aorta. Surgery was performed, and while the operative report noted the presence of severe atherosclerosis of the abdominal aorta, there was no indication of an intraoperative injury to the aorta from Dr. Trabucco’s surgery, according to court documents filed in U.S. District Court for the District of Arizona. An autopsy performed on Mr. Scharf reported “severe calcific aortic atherosclerosis, primarily at the aortic arch and abdominal aorta at the level of the branching of the renal arteries with small adherent thrombus.” The autopsy did not include any indication or suggestion of an intraoperative injury to the abdominal aorta.

A federal jury found unanimously in favor of Dr. Trabucco, concluding that he did nothing wrong. The original medical malpractice case in Mohave County court was ultimately dismissed and in 2014, the bankruptcy court entered an order discharging Dr. Trabucco from all prepetition debts, according to court records.

Meanwhile, as the malicious prosecution case against Mr. Cogan continued, Dr. Trabucco’s name again drew media attention. His former girlfriend was arrested for plotting to kidnap and kill an attorney who was representing Dr. Trabucco’s ex-wife in a divorce proceeding. Renee Perillo was sentenced to 27 years in prison for conspiracy to commit kidnapping and murder for hire for trying to kill Noblesville, Ind., attorney Rebecca Eimerman. Ms. Eimerman was pursuing divorce settlement money from Dr. Trabucco on behalf of his ex-wife. Ms. Perillo’s son was also charged in the crime.

No charges related to the crime were filed against Dr. Trabucco, according to the Hamilton County Prosecutor’s Office and federal charging records. Dr. Trabucco said he was not involved in the incident and had no knowledge of Perillo’s plans.
 

A hard fought – and still continuing – legal battle

After a 3-day trial, jurors in 2018 found that Mr. Cogan owed Dr. Trabucco $8 million for the harm caused by the unfounded claims.

“This has had a tremendous impact on my life,” Dr. Trabucco said. “It’s cost me a lot of time, money, and anguish.”

Mr. Cogan appealed the verdict. An Arizona appeals court in 2020 upheld the finding of liability for malicious prosecution against Mr. Cogan, but it vacated the finding of liability for abuse of process. Because of the partial reversal, the appellate court vacated the $8 million and sent the case back to the Superior Court in Mohave County, Ariz., for a new trial on damages.

But shortly before the December 2021 retrial, both parties agreed to settle for $8 million.

The settlement, however, is not the end of the litigation between the parties.

Late last year, Mr. Cogan filed a new case in the U.S. District Court for the District of Nevada against Dr. Trabucco alleging the Arizona court that tried the malicious prosecution case never had jurisdiction. Mr. Cogan contends that per federal case law, any damages resulting from a bankruptcy court pleading give the federal court exclusive jurisdiction over the matter.

“I believe that I will win the federal court case,” Mr. Cogan said. “If Judge Andrew P. Gordon finds for me, Dr. Trabucco’s judgment in Arizona is void as Arizona did not have subject-matter jurisdiction.”

Dr. Trabucco says the new federal case has no merit.

“The federal courts have no jurisdiction over civil matters, and this should be thrown out,” he said. “However, my attorney is fully prepared to take this to the Supreme Court [if it moves forward].”

At this article’s deadline, the judge had not yet ruled on Dr. Trabucco’s motion to dismiss the federal complaint.
 

Should a physician sue for malicious prosecution?

Dr. Trabucco’s case raises the question of whether physicians should consider suing a patient after winning their malpractice case. As many doctors know, a successful case outcome doesn’t necessarily undo the time spent, income lost, and reputation harm that often comes with a negligence lawsuit. Is suing for malicious prosecution a reasonable route to recoup some of the damages caused by the claim?

“It’s an uphill struggle to prevail,” said Jeffrey Segal, MD, JD. “Have people done it? Yes, they have. Is it easy? No.”

A physician must hit the marks of a distinct checklist to pursue a malicious prosecution case, said Dr. Segal, CEO and founder of Medical Justice, a company that aids and advises physicians on legal matters. One necessary element is that the malpractice case against the physician must have been adjudicated on the merits, he said. For example, the doctor won the case at trial or the case was dismissed on summary judgment. Summary judgment refers to a court tossing the claim because there was no genuine dispute as to any material fact and because the defendant is entitled to judgment as a matter of law.

If the case was dismissed for another reason, such as a technicality, or dropped by the plaintiff, the case would not meet the threshold for a malicious prosecution claim, Dr. Segal explains.

The physician must also show that the lawsuit was instituted with “malice,” meaning with an intent to hurt the physician, and that the lawsuit was brought without “probable cause,” adds J. Richard Moore, JD, a medical malpractice defense attorney based in Indianapolis.

“The courts are still pretty good at weeding out cases with no merit whatsoever, so even if a physician takes a case to trial and wins, it is exceedingly rare that a case that makes it that far, has no merit whatsoever,” Mr. Moore said.

In addition, a plaintiffs’ attorney may be protected from a malicious prosecution claim because they relied on a medical expert’s opinion that reasonable cause existed to file a lawsuit, notes William Sullivan, DO, JD, an emergency physician and attorney based in Frankfort, Ill.

Dr. Sullivan has personal experience with such a challenge. He filed a malicious prosecution claim against a plaintiffs’ attorney after being dismissed from a medical malpractice case. The claim stemmed from Dr. Sullivan inserting an emergency central line into a trauma patient who was taken to surgery and later died. The suit alleged Dr. Sullivan failed to diagnose internal bleeding and failed to perform surgery, although surgeons at the hospital knew internal bleeding was present and Dr. Sullivan had no privileges to perform surgery, he said.

However, Dr. Sullivan was unable to identify the medical expert involved in the claim. Illinois law allows a malpractice plaintiff to withhold the identity of a medical expert who certifies a malpractice lawsuit. Because Dr. Sullivan couldn’t identify the expert, he could not depose the physician, and the law firm claimed there was no malicious prosecution because it relied on the trauma surgeon’s opinion that Dr. Sullivan was liable.

The trial court agreed with the law firm’s argument and dismissed them from the case, Dr. Sullivan said. The trial court also agreed that the expert trauma surgeon should be allowed to remain anonymous in accordance with Illinois law.
 

Alternative options for doctors to recover damages

For physicians who want to recoup after a frivolous claim, but don’t want to dive into another lawsuit, there are other options, say legal experts.

One alternative is filing a motion for sanctions, Dr. Sullivan said. If an attorney files a lawsuit that does not have a reasonable basis in fact or law, that attorney could be subject to sanctions, including paying for the physician’s attorney’s fees and costs, he explained. If a motion for sanctions is granted against an opposing attorney, that fact may be reportable to the attorney’s insurance carrier and also reportable to the attorney’s state licensing board. A motion for sanctions does not require filing of a separate lawsuit and filing a motion for sanctions may allow the defendant physician or the defense attorney to depose the plaintiff attorney regarding the reasonable basis that attorney had for filing a lawsuit, Dr. Sullivan said.

Dr. Sullivan recently represented a physician who won a motion for sanctions. During the legal action against him, Dr. Sullivan presented the plaintiff’s attorney with information showing why his lawsuit did not have a reasonable basis, but the attorney repeatedly ignored the information.

“Eventually, I filed a motion to dismiss the physician from the lawsuit and that motion was granted,” he said. “I also filed a motion for sanctions so that the physician could recover the costs involved in defending the claim. The trial court granted our motion for sanctions against the plaintiff and her law firm and awarded my client more than $10,000.”

Physicians who believe a plaintiffs’ attorney is acting unprofessionally can also file a complaint with the attorney’s bar, Dr. Segal said. And expert witnesses acting in bad faith can be reported to professional societies, medical licensing boards, and/or specialty boards.

“There are a number of avenues to address the sense of justice,” he said. “But if you’re looking for a payday, the only way to do that is by going to court.”

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

Urologist Arnaldo Trabucco, MD, was outraged when he learned of a legal claim filed by a patient’s family blaming him for the patient’s death.

Dr. Trabucco had performed a successful laparoscopic left radical nephrectomy on Gerald Scharf, but he died 3 days later from an unrelated condition, said Dr. Trabucco, who now practices in California. The claims alleged not only wrongful death, but also that Dr. Trabucco “committed willful and malicious actions upon” the patient, eventually resulting in his death, and that Dr. Trabucco’s actions constituted “extreme and outrageous behavior.”

The accusations were levied on behalf of the patient’s family by a bankruptcy attorney who admittedly had no experience in medical malpractice litigation.

“It was a vicious allegation that I intentionally tried to kill my own patient,” said Dr. Trabucco, 66. “It’s an allegation that was outlandish. Those were fighting words.”

As the case dragged on, Dr. Trabucco filed a complaint against the Scharfs and bankruptcy attorney Jeffrey Cogan for malicious prosecution and abuse of process. In 2018, Dr. Trabucco prevailed when a jury awarded him $6,232,000 in compensatory damages and $1,768,000 in punitive damages against Mr. Cogan. (No damages were assessed against the patient’s family.)

“This was a principle issue more than anything else,” Dr. Trabucco said. “My name was tarnished and thrown through the mud. I’m very proud of my name and my reputation.”

Mr. Cogan, a bankruptcy attorney licensed in Nevada and California, disputes that his actions were malicious and disagrees with the jury’s verdict.

“I don’t think I did anything wrong with filing the lawsuit,” he said.

Despite the $8 million award, the legal fight between Dr. Trabucco and Mr. Cogan has continued – and is not over yet.
 

Not your ordinary legal journey

Dr. Trabucco completed his medical training in Rome before moving back to the United States to begin his residency in Brooklyn, New York.

He quietly practiced urology in New York for years before moving to Columbus, Ind., to work at a urology clinic. In 2005, Dr. Trabucco made headlines when the Bartholomew County, Ind., sheriff’s deputies found marijuana plants growing in his home. His medical license was suspended, and he pled guilty to a misdemeanor.

Dr. Trabucco said he was unaware that a family member was growing the plants in the home and that he was not responsible for the operation. The misdemeanor has since been expunged from his record, according to Dr. Trabucco. Bartholomew County records do not list the offense. He later moved to Arizona, where he opened a medical practice.

Before the Scharfs filed their malpractice case in 2013, Dr. Trabucco had been embroiled in a series of unrelated legal disputes, including postdivorce proceedings and a complaint against him by another physician, alleging defamation. In that case, the physician claimed Dr. Trabucco published false and defamatory communications about him, including that the physician committed intentional fraud.

Dr. Trabucco filed his own suit for defamation and infliction of emotional distress against the same physician for alleged threats and harassment and making false reports about him to several Arizona state entities. The defamation suit against Dr. Trabucco ended in a settlement, the terms of which are confidential, according to Mr. Cogan. Dr. Trabucco’s defamation case against the physician was dismissed, according to court records, but they do not specify the reason. Dr. Trabucco said he dropped the defamation case because of the other relentless litigation he was facing.

In November 2012, Dr. Trabucco filed for Chapter 7 bankruptcy protection.

Mr. Cogan was representing Dr. Trabucco’s ex-wife’s interests as a creditor in the bankruptcy proceeding and eventually represented the physician who sued Dr. Trabucco, according to court documents. In all, Mr. Cogan represented six creditors in connection to Dr. Trabucco’s bankruptcy, including the Scharfs. He also took over the Scharfs’ malpractice case in Arizona’s Mohave County Superior Court after their attorney died.

As part of a filing in Nevada bankruptcy court called a “Complaint to Determine Nondischargeabiliy of Debts,” Mr. Cogan alleged that Dr. Trabucco knew he lacked sufficient expertise regarding the laparoscopic nephrectomy, that an intraoperative complication occurred because of his error, and that Dr. Trabucco hid the complication and did not attempt to remedy the situation, among other claims.

In addition to the Mohave County filing and the bankruptcy filing, Mr. Cogan filed a similar medical malpractice case against Dr. Trabucco in Arizona district court.

“I believe, based upon the statements by [a retired medical malpractice attorney], that Dr Trabucco squeezed the abdominal aorta,” Mr. Cogan said. “When he did so, plaque from Mr Scharf blocked blood from going to his remaining his kidney, causing his death. My lawsuit said that Dr Trabucco knew he made a mistake and went home rather than fixing the mistake.”

Dr. Trabucco said the laparoscopic nephrectomy went smoothly. A few hours after the surgery, however, Mr. Scharf was transferred to a Las Vegas hospital with a diagnosis of potential occlusion of the abdominal aorta. Surgery was performed, and while the operative report noted the presence of severe atherosclerosis of the abdominal aorta, there was no indication of an intraoperative injury to the aorta from Dr. Trabucco’s surgery, according to court documents filed in U.S. District Court for the District of Arizona. An autopsy performed on Mr. Scharf reported “severe calcific aortic atherosclerosis, primarily at the aortic arch and abdominal aorta at the level of the branching of the renal arteries with small adherent thrombus.” The autopsy did not include any indication or suggestion of an intraoperative injury to the abdominal aorta.

A federal jury found unanimously in favor of Dr. Trabucco, concluding that he did nothing wrong. The original medical malpractice case in Mohave County court was ultimately dismissed and in 2014, the bankruptcy court entered an order discharging Dr. Trabucco from all prepetition debts, according to court records.

Meanwhile, as the malicious prosecution case against Mr. Cogan continued, Dr. Trabucco’s name again drew media attention. His former girlfriend was arrested for plotting to kidnap and kill an attorney who was representing Dr. Trabucco’s ex-wife in a divorce proceeding. Renee Perillo was sentenced to 27 years in prison for conspiracy to commit kidnapping and murder for hire for trying to kill Noblesville, Ind., attorney Rebecca Eimerman. Ms. Eimerman was pursuing divorce settlement money from Dr. Trabucco on behalf of his ex-wife. Ms. Perillo’s son was also charged in the crime.

No charges related to the crime were filed against Dr. Trabucco, according to the Hamilton County Prosecutor’s Office and federal charging records. Dr. Trabucco said he was not involved in the incident and had no knowledge of Perillo’s plans.
 

A hard fought – and still continuing – legal battle

After a 3-day trial, jurors in 2018 found that Mr. Cogan owed Dr. Trabucco $8 million for the harm caused by the unfounded claims.

“This has had a tremendous impact on my life,” Dr. Trabucco said. “It’s cost me a lot of time, money, and anguish.”

Mr. Cogan appealed the verdict. An Arizona appeals court in 2020 upheld the finding of liability for malicious prosecution against Mr. Cogan, but it vacated the finding of liability for abuse of process. Because of the partial reversal, the appellate court vacated the $8 million and sent the case back to the Superior Court in Mohave County, Ariz., for a new trial on damages.

But shortly before the December 2021 retrial, both parties agreed to settle for $8 million.

The settlement, however, is not the end of the litigation between the parties.

Late last year, Mr. Cogan filed a new case in the U.S. District Court for the District of Nevada against Dr. Trabucco alleging the Arizona court that tried the malicious prosecution case never had jurisdiction. Mr. Cogan contends that per federal case law, any damages resulting from a bankruptcy court pleading give the federal court exclusive jurisdiction over the matter.

“I believe that I will win the federal court case,” Mr. Cogan said. “If Judge Andrew P. Gordon finds for me, Dr. Trabucco’s judgment in Arizona is void as Arizona did not have subject-matter jurisdiction.”

Dr. Trabucco says the new federal case has no merit.

“The federal courts have no jurisdiction over civil matters, and this should be thrown out,” he said. “However, my attorney is fully prepared to take this to the Supreme Court [if it moves forward].”

At this article’s deadline, the judge had not yet ruled on Dr. Trabucco’s motion to dismiss the federal complaint.
 

Should a physician sue for malicious prosecution?

Dr. Trabucco’s case raises the question of whether physicians should consider suing a patient after winning their malpractice case. As many doctors know, a successful case outcome doesn’t necessarily undo the time spent, income lost, and reputation harm that often comes with a negligence lawsuit. Is suing for malicious prosecution a reasonable route to recoup some of the damages caused by the claim?

“It’s an uphill struggle to prevail,” said Jeffrey Segal, MD, JD. “Have people done it? Yes, they have. Is it easy? No.”

A physician must hit the marks of a distinct checklist to pursue a malicious prosecution case, said Dr. Segal, CEO and founder of Medical Justice, a company that aids and advises physicians on legal matters. One necessary element is that the malpractice case against the physician must have been adjudicated on the merits, he said. For example, the doctor won the case at trial or the case was dismissed on summary judgment. Summary judgment refers to a court tossing the claim because there was no genuine dispute as to any material fact and because the defendant is entitled to judgment as a matter of law.

If the case was dismissed for another reason, such as a technicality, or dropped by the plaintiff, the case would not meet the threshold for a malicious prosecution claim, Dr. Segal explains.

The physician must also show that the lawsuit was instituted with “malice,” meaning with an intent to hurt the physician, and that the lawsuit was brought without “probable cause,” adds J. Richard Moore, JD, a medical malpractice defense attorney based in Indianapolis.

“The courts are still pretty good at weeding out cases with no merit whatsoever, so even if a physician takes a case to trial and wins, it is exceedingly rare that a case that makes it that far, has no merit whatsoever,” Mr. Moore said.

In addition, a plaintiffs’ attorney may be protected from a malicious prosecution claim because they relied on a medical expert’s opinion that reasonable cause existed to file a lawsuit, notes William Sullivan, DO, JD, an emergency physician and attorney based in Frankfort, Ill.

Dr. Sullivan has personal experience with such a challenge. He filed a malicious prosecution claim against a plaintiffs’ attorney after being dismissed from a medical malpractice case. The claim stemmed from Dr. Sullivan inserting an emergency central line into a trauma patient who was taken to surgery and later died. The suit alleged Dr. Sullivan failed to diagnose internal bleeding and failed to perform surgery, although surgeons at the hospital knew internal bleeding was present and Dr. Sullivan had no privileges to perform surgery, he said.

However, Dr. Sullivan was unable to identify the medical expert involved in the claim. Illinois law allows a malpractice plaintiff to withhold the identity of a medical expert who certifies a malpractice lawsuit. Because Dr. Sullivan couldn’t identify the expert, he could not depose the physician, and the law firm claimed there was no malicious prosecution because it relied on the trauma surgeon’s opinion that Dr. Sullivan was liable.

The trial court agreed with the law firm’s argument and dismissed them from the case, Dr. Sullivan said. The trial court also agreed that the expert trauma surgeon should be allowed to remain anonymous in accordance with Illinois law.
 

Alternative options for doctors to recover damages

For physicians who want to recoup after a frivolous claim, but don’t want to dive into another lawsuit, there are other options, say legal experts.

One alternative is filing a motion for sanctions, Dr. Sullivan said. If an attorney files a lawsuit that does not have a reasonable basis in fact or law, that attorney could be subject to sanctions, including paying for the physician’s attorney’s fees and costs, he explained. If a motion for sanctions is granted against an opposing attorney, that fact may be reportable to the attorney’s insurance carrier and also reportable to the attorney’s state licensing board. A motion for sanctions does not require filing of a separate lawsuit and filing a motion for sanctions may allow the defendant physician or the defense attorney to depose the plaintiff attorney regarding the reasonable basis that attorney had for filing a lawsuit, Dr. Sullivan said.

Dr. Sullivan recently represented a physician who won a motion for sanctions. During the legal action against him, Dr. Sullivan presented the plaintiff’s attorney with information showing why his lawsuit did not have a reasonable basis, but the attorney repeatedly ignored the information.

“Eventually, I filed a motion to dismiss the physician from the lawsuit and that motion was granted,” he said. “I also filed a motion for sanctions so that the physician could recover the costs involved in defending the claim. The trial court granted our motion for sanctions against the plaintiff and her law firm and awarded my client more than $10,000.”

Physicians who believe a plaintiffs’ attorney is acting unprofessionally can also file a complaint with the attorney’s bar, Dr. Segal said. And expert witnesses acting in bad faith can be reported to professional societies, medical licensing boards, and/or specialty boards.

“There are a number of avenues to address the sense of justice,” he said. “But if you’re looking for a payday, the only way to do that is by going to court.”

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

If the nation’s primary care system were a patient, it would be in critical condition, researchers have found.

In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.

The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”

“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”

The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:

• U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
• Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
• Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.

‘Dismal mess’

Experts reacted to the report with a mix of concern and frustration – but not surprise.

“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”

Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”

“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”

Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”

Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”

R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”

Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.

The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.

Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.

The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.

Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.

“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..

Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.

But Dr. Caplan was skeptical that those measures would do much to correct the problems.

“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”

The authors have disclosed no relevant financial relationships.

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

If the nation’s primary care system were a patient, it would be in critical condition, researchers have found.

In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.

The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”

“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”

The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:

• U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
• Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
• Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.

‘Dismal mess’

Experts reacted to the report with a mix of concern and frustration – but not surprise.

“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”

Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”

“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”

Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”

Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”

R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”

Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.

The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.

Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.

The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.

Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.

“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..

Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.

But Dr. Caplan was skeptical that those measures would do much to correct the problems.

“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”

The authors have disclosed no relevant financial relationships.

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

If the nation’s primary care system were a patient, it would be in critical condition, researchers have found.

In delivery of primary care, including access and coordination, the U.S. trails well behind 10 other wealthy countries, according to a new report from the Commonwealth Fund.

The document, released March 15, concludes that the shortcomings in the U.S. system – from a lack of a relationship with a primary care physician to unequal access to after-hours care – “disproportionately affect Black and Latinx communities and rural areas, exacerbating disparities that have widened during the COVID-19 pandemic.”

“This report really shows that the U.S. is falling behind. We know that a strong primary care system yields better health outcomes. We have a lot to learn from other high-income countries,” coauthor Munira Z. Gunja, MPH, a senior researcher for the Commonwealth Fund’s International Program in Health Policy and Practice Innovations, told this news organization. “At baseline, we really need to make sure that everyone has health insurance in this country so they can actually use primary care services, and we need to increase the supply of those services.”

The report draws from the Commonwealth Fund’s 2019 and 2020 International Health Policy Surveys and the 2020 International Profiles of Health Care Systems. Among the main points:

• U.S. adults are the least likely to have a regular physician or place of care or a long-standing relationship with a primary care provider: 43% of American adults have a long-term relationship with a primary care doctor, compared with highs of 71% in Germany and the Netherlands.
• Access to home visits or after-hours care – excluding emergency department visits – is lowest in the United States (45%). In the Netherlands, Norway, New Zealand, and Germany, the rate is 90% to 96%.
• Half of primary care providers in the United States report adequate coordination with specialists and hospitals – around the average for the 11 countries studied.

‘Dismal mess’

Experts reacted to the report with a mix of concern and frustration – but not surprise.

“The results in this report are not surprising, and we have known them all for a number of years now,” Timothy Hoff, PhD, a health policy expert at Northeastern University, Boston, said. “Primary care doctors remain the backbone of our primary care system. But there are too few of them in the United States, and there likely will remain too few of them in the future. This opens the door to other and more diverse forms of innovation that will be required to help complement the work they do.”

Dr. Hoff, author of Searching for the Family Doctor: Primary Care on the Brink, added that comparing the United States to smaller countries like Norway or the United Kingdom is “somewhat problematic.”

“Our system has to take care of several hundred million people, trapped in a fragmented and market-based delivery system focused on specialty care, each of whom may have a different insurance plan,” he said. “Doing some of the things very small countries with government-funded insurance and a history of strong primary care delivery do in taking care of far fewer citizens is not realistic.”

Jeffrey Borkan, MD, PhD, chair and professor in the department of family medicine at the Alpert Medical School of Brown University, Providence, R.I., said the most shocking finding in the report is that despite spending far more on health care than any other country, “we cannot manage to provide one of the least expensive and most efficacious services: a relationship with a primary care doctor.”

Arthur Caplan, PhD, director of the Division of Medical Ethics at New York University Langone Medical Center, called primary care in this country “a dismal mess. It has been for many years. This is especially so in mental health. Access in many counties is nonexistent, and many primary care physicians are opting into boutique care.”

R. Shawn Martin, CEO of the 133,000-member American Academy of Family Physicians, said, “None of this surprises me. I think these are trendlines; we have been following this for many, many years here at the Academy.”

Mr. Martin added that he was disappointed that the recent, large investments in sharing and digitizing information have not closed the gaps that hinder the efficient and widespread delivery of primary care.

The findings in the report weren’t all bad. More primary care providers in the United States (30%) screen their patients for social needs such as housing, food security, and transportation – the highest among all 11 nations studied.

Also, Commonwealth Fund said the proportion of patients who said they received information on meeting their social needs and screening for domestic violence or social isolation was low everywhere. However, the percentage in the United States, Canada, and Norway was the highest, at 9%. Sweden had the lowest rate for such screenings, at 1%.

The researchers noted that social determinants of health account for as much as 55% of health outcomes. “In some countries, like the United States, the higher rates of receiving such information may be a response to the higher rates of material hardship, along with a weaker safety net,” the report states.

Ms. Gunja and her colleagues suggested several options for changes in policies, including narrowing the wage gap between primary care providers and higher-paid specialists; subsidizing medical school tuition to give students incentives to enter primary care; investing in telehealth to make primary care more accessible; and rewarding and holding providers accountable for continuity of care.

“The U.S. had the largest wage gap and highest tuition fees among the countries we studied,” Ms. Gunja told this news organization..

Researchers noted that U.S. patients could benefit from the introduction of incentives such as those paid in New Zealand to primary health organizations, which receive additional funding per capita to promote health and coordinate care.

But Dr. Caplan was skeptical that those measures would do much to correct the problems.

“We have no will to fix this ongoing, scandalous situation,” he said. “Specialist care still pays inordinately large salaries. Nurses and physician extenders are underused. Academic prestige does little to reward primary care. Plus, patients are not pressing for better access. Sorry, but I see no solutions pending in the current climate. Obamacare barely survived.”

The authors have disclosed no relevant financial relationships.

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

Researchers running the EMPA-KIDNEY trial that’s been testing the safety and efficacy of the SGLT2 inhibitor empagliflozin (Jardiance) in about 6,600 patients with chronic kidney disease (CKD) announced on March 16 that they had stopped the trial early because of positive efficacy that met the study’s prespecified threshold for early termination.

EMPA-KIDNEY is the third major trial of an agent from the sodium-glucose cotransport 2 (SGLT2) inhibitor class tested in patients with CKD to be stopped early because of positive results that met a prespecified termination rule.

HYWARDS/Getty Images

EMPA-KIDNEY enrolled a wider range of patients

EMPA-KIDNEY expands the scope of types of patients with CKD now shown to benefit from treatment with an SGLT2 inhibitor. CREDENCE tested canagliflozin only in patients with type 2 diabetes and diabetic nephropathy, and in DAPA-CKD, two-thirds of enrolled patients had type 2 diabetes, and all had CKD. In EMPA-KIDNEY, 46% of the 6,609 enrolled patients had diabetes (including a very small number with type 1 diabetes).

Another departure from prior studies of an SGLT2 inhibitor for patients selected primarily for having CKD was that in EMPA-KIDNEY, 20% of patients did not have albuminuria, and for 34%, eGFR at entry was less than 30 mL/min/1.73 m², with all enrolled patients required to have an eGFR at entry of greater than or equal to 20 mL/min/1.73 m². Average eGFR in EMPA-KIDNEY was about 38 mL/min/1.73 m². To be included in the trial, patients were not required to have albuminuria, except those whose eGFR was greater than or equal to 45 mL/min/1.73 m².

In DAPA-CKD, the minimum eGFR at entry had to be greater than or equal to 25 mL/min/1.73 m², and roughly 14% of enrolled patients had an eGFR of less than 30 mL/min/1.73 m². The average eGFR in DAPA-CKD was about 43 mL/min/1.73 m². In addition, all patients had at least microalbuminuria, with a minimum urinary albumin-to-creatinine ratio of 200. In CREDENCE, the minimum eGFR for enrollment was 30 mL/min/1.73 m², and the average eGFR was about 56 mL/min/1.73 m². All patients in CREDENCE had to have macroalbuminuria, with a urinary albumin-to-creatinine ratio of more than 300.

According to the researchers who designed EMPA-KIDNEY, the trial enrollment criteria aimed to include adults with CKD “who are frequently seen in practice but were under-represented in previous SGLT2 inhibitor trials.”

Indications for empagliflozin are expanding

The success of empagliflozin in EMPA-KIDNEY follows its positive results in both the EMPEROR-Reduced and EMPEROR-Preserved trials, which collectively proved the efficacy of the agent for patients with heart failure regardless of their left ventricular ejection fraction and regardless of whether they also had diabetes.

These results led the U.S. Food and Drug Administration to recently expand the labeled indication for empagliflozin to all patients with heart failure. Empagliflozin also has labeled indications for glycemic control in patients with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

As of today, empagliflozin has no labeled indication for treating patients with CKD. Dapagliflozin received that indication in April 2021, and canagliflozin received an indication for treating patients with type 2 diabetes, diabetic nephropathy, and albuminuria in September 2019.

EMPA-KIDNEY is sponsored by Boehringer Ingelheim and Lilly, the two companies that jointly market empagliflozin (Jardiance).

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

Researchers running the EMPA-KIDNEY trial that’s been testing the safety and efficacy of the SGLT2 inhibitor empagliflozin (Jardiance) in about 6,600 patients with chronic kidney disease (CKD) announced on March 16 that they had stopped the trial early because of positive efficacy that met the study’s prespecified threshold for early termination.

EMPA-KIDNEY is the third major trial of an agent from the sodium-glucose cotransport 2 (SGLT2) inhibitor class tested in patients with CKD to be stopped early because of positive results that met a prespecified termination rule.

HYWARDS/Getty Images

EMPA-KIDNEY enrolled a wider range of patients

EMPA-KIDNEY expands the scope of types of patients with CKD now shown to benefit from treatment with an SGLT2 inhibitor. CREDENCE tested canagliflozin only in patients with type 2 diabetes and diabetic nephropathy, and in DAPA-CKD, two-thirds of enrolled patients had type 2 diabetes, and all had CKD. In EMPA-KIDNEY, 46% of the 6,609 enrolled patients had diabetes (including a very small number with type 1 diabetes).

Another departure from prior studies of an SGLT2 inhibitor for patients selected primarily for having CKD was that in EMPA-KIDNEY, 20% of patients did not have albuminuria, and for 34%, eGFR at entry was less than 30 mL/min/1.73 m², with all enrolled patients required to have an eGFR at entry of greater than or equal to 20 mL/min/1.73 m². Average eGFR in EMPA-KIDNEY was about 38 mL/min/1.73 m². To be included in the trial, patients were not required to have albuminuria, except those whose eGFR was greater than or equal to 45 mL/min/1.73 m².

In DAPA-CKD, the minimum eGFR at entry had to be greater than or equal to 25 mL/min/1.73 m², and roughly 14% of enrolled patients had an eGFR of less than 30 mL/min/1.73 m². The average eGFR in DAPA-CKD was about 43 mL/min/1.73 m². In addition, all patients had at least microalbuminuria, with a minimum urinary albumin-to-creatinine ratio of 200. In CREDENCE, the minimum eGFR for enrollment was 30 mL/min/1.73 m², and the average eGFR was about 56 mL/min/1.73 m². All patients in CREDENCE had to have macroalbuminuria, with a urinary albumin-to-creatinine ratio of more than 300.

According to the researchers who designed EMPA-KIDNEY, the trial enrollment criteria aimed to include adults with CKD “who are frequently seen in practice but were under-represented in previous SGLT2 inhibitor trials.”

Indications for empagliflozin are expanding

The success of empagliflozin in EMPA-KIDNEY follows its positive results in both the EMPEROR-Reduced and EMPEROR-Preserved trials, which collectively proved the efficacy of the agent for patients with heart failure regardless of their left ventricular ejection fraction and regardless of whether they also had diabetes.

These results led the U.S. Food and Drug Administration to recently expand the labeled indication for empagliflozin to all patients with heart failure. Empagliflozin also has labeled indications for glycemic control in patients with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

As of today, empagliflozin has no labeled indication for treating patients with CKD. Dapagliflozin received that indication in April 2021, and canagliflozin received an indication for treating patients with type 2 diabetes, diabetic nephropathy, and albuminuria in September 2019.

EMPA-KIDNEY is sponsored by Boehringer Ingelheim and Lilly, the two companies that jointly market empagliflozin (Jardiance).

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

Researchers running the EMPA-KIDNEY trial that’s been testing the safety and efficacy of the SGLT2 inhibitor empagliflozin (Jardiance) in about 6,600 patients with chronic kidney disease (CKD) announced on March 16 that they had stopped the trial early because of positive efficacy that met the study’s prespecified threshold for early termination.

EMPA-KIDNEY is the third major trial of an agent from the sodium-glucose cotransport 2 (SGLT2) inhibitor class tested in patients with CKD to be stopped early because of positive results that met a prespecified termination rule.

HYWARDS/Getty Images

EMPA-KIDNEY enrolled a wider range of patients

EMPA-KIDNEY expands the scope of types of patients with CKD now shown to benefit from treatment with an SGLT2 inhibitor. CREDENCE tested canagliflozin only in patients with type 2 diabetes and diabetic nephropathy, and in DAPA-CKD, two-thirds of enrolled patients had type 2 diabetes, and all had CKD. In EMPA-KIDNEY, 46% of the 6,609 enrolled patients had diabetes (including a very small number with type 1 diabetes).

Another departure from prior studies of an SGLT2 inhibitor for patients selected primarily for having CKD was that in EMPA-KIDNEY, 20% of patients did not have albuminuria, and for 34%, eGFR at entry was less than 30 mL/min/1.73 m², with all enrolled patients required to have an eGFR at entry of greater than or equal to 20 mL/min/1.73 m². Average eGFR in EMPA-KIDNEY was about 38 mL/min/1.73 m². To be included in the trial, patients were not required to have albuminuria, except those whose eGFR was greater than or equal to 45 mL/min/1.73 m².

In DAPA-CKD, the minimum eGFR at entry had to be greater than or equal to 25 mL/min/1.73 m², and roughly 14% of enrolled patients had an eGFR of less than 30 mL/min/1.73 m². The average eGFR in DAPA-CKD was about 43 mL/min/1.73 m². In addition, all patients had at least microalbuminuria, with a minimum urinary albumin-to-creatinine ratio of 200. In CREDENCE, the minimum eGFR for enrollment was 30 mL/min/1.73 m², and the average eGFR was about 56 mL/min/1.73 m². All patients in CREDENCE had to have macroalbuminuria, with a urinary albumin-to-creatinine ratio of more than 300.

According to the researchers who designed EMPA-KIDNEY, the trial enrollment criteria aimed to include adults with CKD “who are frequently seen in practice but were under-represented in previous SGLT2 inhibitor trials.”

Indications for empagliflozin are expanding

The success of empagliflozin in EMPA-KIDNEY follows its positive results in both the EMPEROR-Reduced and EMPEROR-Preserved trials, which collectively proved the efficacy of the agent for patients with heart failure regardless of their left ventricular ejection fraction and regardless of whether they also had diabetes.

These results led the U.S. Food and Drug Administration to recently expand the labeled indication for empagliflozin to all patients with heart failure. Empagliflozin also has labeled indications for glycemic control in patients with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

As of today, empagliflozin has no labeled indication for treating patients with CKD. Dapagliflozin received that indication in April 2021, and canagliflozin received an indication for treating patients with type 2 diabetes, diabetic nephropathy, and albuminuria in September 2019.

EMPA-KIDNEY is sponsored by Boehringer Ingelheim and Lilly, the two companies that jointly market empagliflozin (Jardiance).

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

Excess weight over a lifetime may play a greater role in a person’s risk for colorectal cancer (CRC) than previously thought, according to new research.

In their paper published online March 17 in JAMA Oncology, the authors liken the cumulative effects of a lifetime with overweight or obesity to the increased risk of cancer the more people smoke over time.

This population-based, case-control study was led by Xiangwei Li, MSc, of the division of clinical epidemiology and aging research at the German Cancer Research Center in Heidelberg.

It looked at height and self-reported weight documented in 10-year increments starting at age 20 years up to the current age for 5,635 people with CRC compared with 4,515 people in a control group.

Odds for colorectal cancer increased substantially over the decades when people carried the excess weight long term compared with participants who remained within the normal weight range during the period.

Coauthor Hermann Brenner, MD, MPH, a colleague in Li’s division at the German Cancer Research Center, said in an interview that a key message in the research is that “overweight and obesity are likely to increase the risk of colorectal cancer more strongly than suggested by previous studies that typically had considered body weight only at a single point of time.”

The researchers used a measure of weighted number of years lived with overweight or obesity (WYOs) determined by multiplying excess body mass index by number of years the person carried the excess weight.

They found a link between WYOs and CRC risk, with adjusted odds ratios (ORs) increasing from 1.25 (95% confidence interval [CI], 1.09-1.44) to 2.54 (95% CI, 2.24-2.89) from the first to the fourth quartile of WYOs, compared with people who stayed within normal weight parameters.

The odds went up substantially the longer the time carrying the excess weight.

“Each SD increment in WYOs was associated with an increase of CRC risk by 55% (adjusted OR, 1.55; 95% CI, 1.46-1.64),” the authors wrote. “This OR was higher than the OR per SD increase of excess body mass index at any single point of time, which ranged from 1.04 (95% CI, 0.93-1.16) to 1.27 (95% CI 1.16-1.39).”

Dr. Brenner said that although this study focused on colorectal cancer, “the same is likely to apply for other cancers and other chronic diseases.”

Prevention of overweight and obesity to reduce burden of cancer and other chronic diseases “should become a public health priority,” he said.
 

Preventing overweight in childhood is important

Overweight and obesity increasingly are starting in childhood, he noted, and may be a lifelong burden.

Therefore, “efforts to prevent their development in childhood, adolescence, and young adulthood are particularly important,” Dr. Brenner said.

The average age of the patients was 68 years in both the CRC and control groups. There were more men than women in both groups: 59.7% were men in the CRC group and 61.1% were men in the control group.

“Our proposed concept of WYOs is comparable to the concept of pack-years in that WYOs can be considered a weighted measure of years lived with the exposure, with weights reflecting the intensity of exposure,” the authors wrote.
 

Study helps confirm what is becoming more clear to researchers

Kimmie Ng, MD, MPH, a professor at Harvard Medical School and oncologist at Dana-Farber Cancer Institute, both in Boston, said in an interview that the study helps confirm what is becoming more clear to researchers.

“We do think that exposures over the life course are the ones that will be most strongly contributing to a risk of colorectal cancer as an adult,” she said. “With obesity, what we think is happening is that it’s setting up this milieu of chronic inflammation and insulin resistance and we know those two factors can lead to higher rates of colorectal cancer development and increased tumor growth.”

She said the ideal, but impractical, way to do the study would be to follow healthy people from childhood and document their weight over a lifetime. In this case-control study, people were asked to recall their weight at different time periods, which is a limitation and could lead to recall bias.

But the study is important, Dr. Ng said, and it adds convincing evidence that addressing the link between excess weight and CRC and chronic diseases should be a public health priority. “With the recent rise in young-onset colorectal cancer since the 1990s there has been a lot of interest in looking at whether obesity is a major contributor to that rising trend,” Dr. Ng noted. “If obesity is truly linked to colorectal cancer, these rising rates of obesity are very worrisome for potentially leading to more colorectal cancers in young adulthood and beyond.“

The study authors and Dr. Ng report no relevant financial relationships.

The new research was funded by the German Research Council, the Interdisciplinary Research Program of the National Center for Tumor Diseases, Germany, and the German Federal Ministry of Education and Research.

Excess weight over a lifetime may play a greater role in a person’s risk for colorectal cancer (CRC) than previously thought, according to new research.

In their paper published online March 17 in JAMA Oncology, the authors liken the cumulative effects of a lifetime with overweight or obesity to the increased risk of cancer the more people smoke over time.

This population-based, case-control study was led by Xiangwei Li, MSc, of the division of clinical epidemiology and aging research at the German Cancer Research Center in Heidelberg.

It looked at height and self-reported weight documented in 10-year increments starting at age 20 years up to the current age for 5,635 people with CRC compared with 4,515 people in a control group.

Odds for colorectal cancer increased substantially over the decades when people carried the excess weight long term compared with participants who remained within the normal weight range during the period.

Coauthor Hermann Brenner, MD, MPH, a colleague in Li’s division at the German Cancer Research Center, said in an interview that a key message in the research is that “overweight and obesity are likely to increase the risk of colorectal cancer more strongly than suggested by previous studies that typically had considered body weight only at a single point of time.”

The researchers used a measure of weighted number of years lived with overweight or obesity (WYOs) determined by multiplying excess body mass index by number of years the person carried the excess weight.

They found a link between WYOs and CRC risk, with adjusted odds ratios (ORs) increasing from 1.25 (95% confidence interval [CI], 1.09-1.44) to 2.54 (95% CI, 2.24-2.89) from the first to the fourth quartile of WYOs, compared with people who stayed within normal weight parameters.

The odds went up substantially the longer the time carrying the excess weight.

“Each SD increment in WYOs was associated with an increase of CRC risk by 55% (adjusted OR, 1.55; 95% CI, 1.46-1.64),” the authors wrote. “This OR was higher than the OR per SD increase of excess body mass index at any single point of time, which ranged from 1.04 (95% CI, 0.93-1.16) to 1.27 (95% CI 1.16-1.39).”

Dr. Brenner said that although this study focused on colorectal cancer, “the same is likely to apply for other cancers and other chronic diseases.”

Prevention of overweight and obesity to reduce burden of cancer and other chronic diseases “should become a public health priority,” he said.
 

Preventing overweight in childhood is important

Overweight and obesity increasingly are starting in childhood, he noted, and may be a lifelong burden.

Therefore, “efforts to prevent their development in childhood, adolescence, and young adulthood are particularly important,” Dr. Brenner said.

The average age of the patients was 68 years in both the CRC and control groups. There were more men than women in both groups: 59.7% were men in the CRC group and 61.1% were men in the control group.

“Our proposed concept of WYOs is comparable to the concept of pack-years in that WYOs can be considered a weighted measure of years lived with the exposure, with weights reflecting the intensity of exposure,” the authors wrote.
 

Study helps confirm what is becoming more clear to researchers

Kimmie Ng, MD, MPH, a professor at Harvard Medical School and oncologist at Dana-Farber Cancer Institute, both in Boston, said in an interview that the study helps confirm what is becoming more clear to researchers.

“We do think that exposures over the life course are the ones that will be most strongly contributing to a risk of colorectal cancer as an adult,” she said. “With obesity, what we think is happening is that it’s setting up this milieu of chronic inflammation and insulin resistance and we know those two factors can lead to higher rates of colorectal cancer development and increased tumor growth.”

She said the ideal, but impractical, way to do the study would be to follow healthy people from childhood and document their weight over a lifetime. In this case-control study, people were asked to recall their weight at different time periods, which is a limitation and could lead to recall bias.

But the study is important, Dr. Ng said, and it adds convincing evidence that addressing the link between excess weight and CRC and chronic diseases should be a public health priority. “With the recent rise in young-onset colorectal cancer since the 1990s there has been a lot of interest in looking at whether obesity is a major contributor to that rising trend,” Dr. Ng noted. “If obesity is truly linked to colorectal cancer, these rising rates of obesity are very worrisome for potentially leading to more colorectal cancers in young adulthood and beyond.“

The study authors and Dr. Ng report no relevant financial relationships.

The new research was funded by the German Research Council, the Interdisciplinary Research Program of the National Center for Tumor Diseases, Germany, and the German Federal Ministry of Education and Research.

Excess weight over a lifetime may play a greater role in a person’s risk for colorectal cancer (CRC) than previously thought, according to new research.

In their paper published online March 17 in JAMA Oncology, the authors liken the cumulative effects of a lifetime with overweight or obesity to the increased risk of cancer the more people smoke over time.

This population-based, case-control study was led by Xiangwei Li, MSc, of the division of clinical epidemiology and aging research at the German Cancer Research Center in Heidelberg.

It looked at height and self-reported weight documented in 10-year increments starting at age 20 years up to the current age for 5,635 people with CRC compared with 4,515 people in a control group.

Odds for colorectal cancer increased substantially over the decades when people carried the excess weight long term compared with participants who remained within the normal weight range during the period.

Coauthor Hermann Brenner, MD, MPH, a colleague in Li’s division at the German Cancer Research Center, said in an interview that a key message in the research is that “overweight and obesity are likely to increase the risk of colorectal cancer more strongly than suggested by previous studies that typically had considered body weight only at a single point of time.”

The researchers used a measure of weighted number of years lived with overweight or obesity (WYOs) determined by multiplying excess body mass index by number of years the person carried the excess weight.

They found a link between WYOs and CRC risk, with adjusted odds ratios (ORs) increasing from 1.25 (95% confidence interval [CI], 1.09-1.44) to 2.54 (95% CI, 2.24-2.89) from the first to the fourth quartile of WYOs, compared with people who stayed within normal weight parameters.

The odds went up substantially the longer the time carrying the excess weight.

“Each SD increment in WYOs was associated with an increase of CRC risk by 55% (adjusted OR, 1.55; 95% CI, 1.46-1.64),” the authors wrote. “This OR was higher than the OR per SD increase of excess body mass index at any single point of time, which ranged from 1.04 (95% CI, 0.93-1.16) to 1.27 (95% CI 1.16-1.39).”

Dr. Brenner said that although this study focused on colorectal cancer, “the same is likely to apply for other cancers and other chronic diseases.”

Prevention of overweight and obesity to reduce burden of cancer and other chronic diseases “should become a public health priority,” he said.
 

Preventing overweight in childhood is important

Overweight and obesity increasingly are starting in childhood, he noted, and may be a lifelong burden.

Therefore, “efforts to prevent their development in childhood, adolescence, and young adulthood are particularly important,” Dr. Brenner said.

The average age of the patients was 68 years in both the CRC and control groups. There were more men than women in both groups: 59.7% were men in the CRC group and 61.1% were men in the control group.

“Our proposed concept of WYOs is comparable to the concept of pack-years in that WYOs can be considered a weighted measure of years lived with the exposure, with weights reflecting the intensity of exposure,” the authors wrote.
 

Study helps confirm what is becoming more clear to researchers

Kimmie Ng, MD, MPH, a professor at Harvard Medical School and oncologist at Dana-Farber Cancer Institute, both in Boston, said in an interview that the study helps confirm what is becoming more clear to researchers.

“We do think that exposures over the life course are the ones that will be most strongly contributing to a risk of colorectal cancer as an adult,” she said. “With obesity, what we think is happening is that it’s setting up this milieu of chronic inflammation and insulin resistance and we know those two factors can lead to higher rates of colorectal cancer development and increased tumor growth.”

She said the ideal, but impractical, way to do the study would be to follow healthy people from childhood and document their weight over a lifetime. In this case-control study, people were asked to recall their weight at different time periods, which is a limitation and could lead to recall bias.

But the study is important, Dr. Ng said, and it adds convincing evidence that addressing the link between excess weight and CRC and chronic diseases should be a public health priority. “With the recent rise in young-onset colorectal cancer since the 1990s there has been a lot of interest in looking at whether obesity is a major contributor to that rising trend,” Dr. Ng noted. “If obesity is truly linked to colorectal cancer, these rising rates of obesity are very worrisome for potentially leading to more colorectal cancers in young adulthood and beyond.“

The study authors and Dr. Ng report no relevant financial relationships.

The new research was funded by the German Research Council, the Interdisciplinary Research Program of the National Center for Tumor Diseases, Germany, and the German Federal Ministry of Education and Research.

When the Food and Drug Administration approved abatacept in December 2021 as prophylaxis for acute graft-versus-host disease (aGVHD) in adults and children 2 years and older who are undergoing hematopoietic stem cell transplantation (HSCT), the announcement was notable for couple of key reasons.

Firstly, abatacept – initially approved in 2005 as a treatment for rheumatoid arthritis – was being repurposed for a different indication. Secondly, the new use for abatacept held promise for patients who are receiving HSCT and have trouble finding available, matched unrelated donors, a problem that disproportionately affects people of color.

Abatacept was approved based on results from the ABA2 trial, which evaluated 142 adults and children with hematologic malignancies who received a four-dose regimen of abatacept in addition to standard of care – a calcineurin inhibitor (CNI) plus methotrexate (MTX) – prior to undergoing an 8/8 HLA-matched, unrelated donor (URD) HSCT, or standard of care alone.

Another arm of the trial examined 43 recipients of a 7/8 HLA-mismatched URD HSCT who received abatacept plus standard of care, compared with a prespecified registry cohort group provided by the Center for International Blood and Marrow Transplant Research, who received CNI and MTX.

Results published in the Journal of Clinical Oncology showed the proportion of patients in the 8/8 group with severe aGVHD in the abatacept group 100 days after HSCT was not significantly lower, compared with the standard of care group (6.8% vs. 14.8%; P = .13), but there was a significant improvement in severe aGVHD–free survival (SGFS) 180 days after HSCT in the abatacept group, compared with the group that received standard of care (93.2% vs. 80%; P = .05).

Among patients in the 7/8 group, there was a significant difference in the proportion of patients with severe aGVHD favoring the abatacept group (2.3% vs. 30.2%; P < .001), and significantly improved SGFS, compared with the CIBMTR registry cohort (97.7% vs. 58.7%; P < .001)

A post hoc analysis of ABA2 published as a research letter in Blood Advances assessed abatacept using real-world data from CIBMTR. Researchers compared the 8/8 group that received standard of care with the 7/8 group that received abatacept plus standard of care and found no significant differences between relapse-free survival and overall survival for patients in the 8/8 group (adjusted hazard ratio, 0.60; 95% confidence interval, 0.28-1.28; P = .19) and 7/8 group (aHR, 0.77; 95% CI, 0.34-1.71; P = .51).

The results suggest “abatacept may eliminate that risk of a mismatched transplant in the setting of that analysis and that small cohort that was assessed there, which is good news for patients that may not have a fully matched donor on the registry,” said Stephen Spellman, vice president at Be The Match Research (operated by the National Marrow Donor Program), and senior scientific director of CIBMTR. The findings from ABA2 “were even more impressive than necessarily expected, especially in the 7/8 arm. This is a truly substantial reduction in acute GVHD risk in that patient population,” he said in an interview.
 

Could abatacept fuel greater use of mismatched, unrelated donors?

One downside of using an HLA-mismatched donor is the potential risk of developing aGVHD, Doris M. Ponce, MD, a hematologic oncologist with Memorial Sloan Kettering Cancer Center in New York, who was not involved with the research, said in an interview.

Potential risk factors for aGVHD include “having a female multiparous donor, HLA-mismatched donor, unrelated donor, donor and recipient age (>40 years), [peripheral blood stem cell] stem cell graft, recipient [cytomegalovirus] serostatus (recipient/donor), myeloablative conditioning, [total body irradiation]–based conditioning, [and] gut microbiome dysbiosis,” Dr. Ponce explained.

Abatacept’s approval may have particular relevance for people of color. “It’s been understood for a long time that the likelihood of finding an 8/8 well-matched, volunteer unrelated donor varies by race or ethnicity,” Steven Devine, MD, a board-certified oncologist who is chief medical officer of Be The Match and associate scientific director at CIBMTR, said in an interview.

Mr. Spellman noted that, of the more than 35 million donors on worldwide registries accessible through the National Marrow Donor Program’s Be The Match Registry, “the match rates differ quite substantially by race and ethnicity.” Approximately 29% of African Americans find a full match on the registry, compared with 81% of Whites, 49% of Hispanics, and 47% Asian/Pacific Islanders.

“Being able to utilize a 7/8 match in a safe, effective manner using abatacept, which abatacept has been approved for, does increase those match rates quite substantially,” he explained. Among African Americans, this means the match rate increases to 84%, among Hispanics and Asian/Pacific Islanders to approximately 90%, and among Whites to about 98%.

That kind of improvement in the match rate is “the equivalent of adding more than more than 10 million ethnically diverse donors to the registry in 1 day,” Dr. Devine said. “The availability of abatacept could really level the playing field for patients in need of a lifesaving transplant.”
 

Further study of abatacept

With abatacept, “I think the results are really encouraging, and I think that further studies [are needed] to better define how the drug would work and whether it can later prevent chronic graft versus host disease,” Dr. Devine said. He said the ABA3 trial has been designed around this question, with the hypothesis that extending abatacept to an eight-dose regimen may help with chronic GVHD.

Although the FDA’s approval of abatacept was recent, Mr. Spellman said, Be The Match has seen early indications that mismatched donors in the registry are being used, which may point to an increased utilization of abatacept. “Through October to December of 2021, there was a pretty substantial increase in the use of mismatched, unrelated donors in that time frame.”

Dr. Devine noted that he is seeing a lot of interest in using abatacept. “I think people are still learning how best to incorporate it into their standard of care right now.”

Meanwhile, Memorial Sloan Kettering Cancer Center is already planning to use abatacept, Dr. Ponce noted. “We have abatacept in our formulary for adult and children, and are planning on using it for patients receiving an unmodified graft from a [matched unrelated donor] or 1-allele [mismatched unrelated donor] using CNI and MTX-based GVHD prophylaxis.”

Dr. Devine and Mr. Spellman are employees of Be The Match and CIBMTR, which provided the registry control group for the ABA2 trial. Dr. Devine also reported that he has been a scientific advisory board member for Bristol-Myers Squibb. Dr. Ponce reports no relevant conflicts of interest.

When the Food and Drug Administration approved abatacept in December 2021 as prophylaxis for acute graft-versus-host disease (aGVHD) in adults and children 2 years and older who are undergoing hematopoietic stem cell transplantation (HSCT), the announcement was notable for couple of key reasons.

Firstly, abatacept – initially approved in 2005 as a treatment for rheumatoid arthritis – was being repurposed for a different indication. Secondly, the new use for abatacept held promise for patients who are receiving HSCT and have trouble finding available, matched unrelated donors, a problem that disproportionately affects people of color.

Abatacept was approved based on results from the ABA2 trial, which evaluated 142 adults and children with hematologic malignancies who received a four-dose regimen of abatacept in addition to standard of care – a calcineurin inhibitor (CNI) plus methotrexate (MTX) – prior to undergoing an 8/8 HLA-matched, unrelated donor (URD) HSCT, or standard of care alone.

Another arm of the trial examined 43 recipients of a 7/8 HLA-mismatched URD HSCT who received abatacept plus standard of care, compared with a prespecified registry cohort group provided by the Center for International Blood and Marrow Transplant Research, who received CNI and MTX.

Results published in the Journal of Clinical Oncology showed the proportion of patients in the 8/8 group with severe aGVHD in the abatacept group 100 days after HSCT was not significantly lower, compared with the standard of care group (6.8% vs. 14.8%; P = .13), but there was a significant improvement in severe aGVHD–free survival (SGFS) 180 days after HSCT in the abatacept group, compared with the group that received standard of care (93.2% vs. 80%; P = .05).

Among patients in the 7/8 group, there was a significant difference in the proportion of patients with severe aGVHD favoring the abatacept group (2.3% vs. 30.2%; P < .001), and significantly improved SGFS, compared with the CIBMTR registry cohort (97.7% vs. 58.7%; P < .001)

A post hoc analysis of ABA2 published as a research letter in Blood Advances assessed abatacept using real-world data from CIBMTR. Researchers compared the 8/8 group that received standard of care with the 7/8 group that received abatacept plus standard of care and found no significant differences between relapse-free survival and overall survival for patients in the 8/8 group (adjusted hazard ratio, 0.60; 95% confidence interval, 0.28-1.28; P = .19) and 7/8 group (aHR, 0.77; 95% CI, 0.34-1.71; P = .51).

The results suggest “abatacept may eliminate that risk of a mismatched transplant in the setting of that analysis and that small cohort that was assessed there, which is good news for patients that may not have a fully matched donor on the registry,” said Stephen Spellman, vice president at Be The Match Research (operated by the National Marrow Donor Program), and senior scientific director of CIBMTR. The findings from ABA2 “were even more impressive than necessarily expected, especially in the 7/8 arm. This is a truly substantial reduction in acute GVHD risk in that patient population,” he said in an interview.
 

Could abatacept fuel greater use of mismatched, unrelated donors?

One downside of using an HLA-mismatched donor is the potential risk of developing aGVHD, Doris M. Ponce, MD, a hematologic oncologist with Memorial Sloan Kettering Cancer Center in New York, who was not involved with the research, said in an interview.

Potential risk factors for aGVHD include “having a female multiparous donor, HLA-mismatched donor, unrelated donor, donor and recipient age (>40 years), [peripheral blood stem cell] stem cell graft, recipient [cytomegalovirus] serostatus (recipient/donor), myeloablative conditioning, [total body irradiation]–based conditioning, [and] gut microbiome dysbiosis,” Dr. Ponce explained.

Abatacept’s approval may have particular relevance for people of color. “It’s been understood for a long time that the likelihood of finding an 8/8 well-matched, volunteer unrelated donor varies by race or ethnicity,” Steven Devine, MD, a board-certified oncologist who is chief medical officer of Be The Match and associate scientific director at CIBMTR, said in an interview.

Mr. Spellman noted that, of the more than 35 million donors on worldwide registries accessible through the National Marrow Donor Program’s Be The Match Registry, “the match rates differ quite substantially by race and ethnicity.” Approximately 29% of African Americans find a full match on the registry, compared with 81% of Whites, 49% of Hispanics, and 47% Asian/Pacific Islanders.

“Being able to utilize a 7/8 match in a safe, effective manner using abatacept, which abatacept has been approved for, does increase those match rates quite substantially,” he explained. Among African Americans, this means the match rate increases to 84%, among Hispanics and Asian/Pacific Islanders to approximately 90%, and among Whites to about 98%.

That kind of improvement in the match rate is “the equivalent of adding more than more than 10 million ethnically diverse donors to the registry in 1 day,” Dr. Devine said. “The availability of abatacept could really level the playing field for patients in need of a lifesaving transplant.”
 

Further study of abatacept

With abatacept, “I think the results are really encouraging, and I think that further studies [are needed] to better define how the drug would work and whether it can later prevent chronic graft versus host disease,” Dr. Devine said. He said the ABA3 trial has been designed around this question, with the hypothesis that extending abatacept to an eight-dose regimen may help with chronic GVHD.

Although the FDA’s approval of abatacept was recent, Mr. Spellman said, Be The Match has seen early indications that mismatched donors in the registry are being used, which may point to an increased utilization of abatacept. “Through October to December of 2021, there was a pretty substantial increase in the use of mismatched, unrelated donors in that time frame.”

Dr. Devine noted that he is seeing a lot of interest in using abatacept. “I think people are still learning how best to incorporate it into their standard of care right now.”

Meanwhile, Memorial Sloan Kettering Cancer Center is already planning to use abatacept, Dr. Ponce noted. “We have abatacept in our formulary for adult and children, and are planning on using it for patients receiving an unmodified graft from a [matched unrelated donor] or 1-allele [mismatched unrelated donor] using CNI and MTX-based GVHD prophylaxis.”

Dr. Devine and Mr. Spellman are employees of Be The Match and CIBMTR, which provided the registry control group for the ABA2 trial. Dr. Devine also reported that he has been a scientific advisory board member for Bristol-Myers Squibb. Dr. Ponce reports no relevant conflicts of interest.

When the Food and Drug Administration approved abatacept in December 2021 as prophylaxis for acute graft-versus-host disease (aGVHD) in adults and children 2 years and older who are undergoing hematopoietic stem cell transplantation (HSCT), the announcement was notable for couple of key reasons.

Firstly, abatacept – initially approved in 2005 as a treatment for rheumatoid arthritis – was being repurposed for a different indication. Secondly, the new use for abatacept held promise for patients who are receiving HSCT and have trouble finding available, matched unrelated donors, a problem that disproportionately affects people of color.

Abatacept was approved based on results from the ABA2 trial, which evaluated 142 adults and children with hematologic malignancies who received a four-dose regimen of abatacept in addition to standard of care – a calcineurin inhibitor (CNI) plus methotrexate (MTX) – prior to undergoing an 8/8 HLA-matched, unrelated donor (URD) HSCT, or standard of care alone.

Another arm of the trial examined 43 recipients of a 7/8 HLA-mismatched URD HSCT who received abatacept plus standard of care, compared with a prespecified registry cohort group provided by the Center for International Blood and Marrow Transplant Research, who received CNI and MTX.

Results published in the Journal of Clinical Oncology showed the proportion of patients in the 8/8 group with severe aGVHD in the abatacept group 100 days after HSCT was not significantly lower, compared with the standard of care group (6.8% vs. 14.8%; P = .13), but there was a significant improvement in severe aGVHD–free survival (SGFS) 180 days after HSCT in the abatacept group, compared with the group that received standard of care (93.2% vs. 80%; P = .05).

Among patients in the 7/8 group, there was a significant difference in the proportion of patients with severe aGVHD favoring the abatacept group (2.3% vs. 30.2%; P < .001), and significantly improved SGFS, compared with the CIBMTR registry cohort (97.7% vs. 58.7%; P < .001)

A post hoc analysis of ABA2 published as a research letter in Blood Advances assessed abatacept using real-world data from CIBMTR. Researchers compared the 8/8 group that received standard of care with the 7/8 group that received abatacept plus standard of care and found no significant differences between relapse-free survival and overall survival for patients in the 8/8 group (adjusted hazard ratio, 0.60; 95% confidence interval, 0.28-1.28; P = .19) and 7/8 group (aHR, 0.77; 95% CI, 0.34-1.71; P = .51).

The results suggest “abatacept may eliminate that risk of a mismatched transplant in the setting of that analysis and that small cohort that was assessed there, which is good news for patients that may not have a fully matched donor on the registry,” said Stephen Spellman, vice president at Be The Match Research (operated by the National Marrow Donor Program), and senior scientific director of CIBMTR. The findings from ABA2 “were even more impressive than necessarily expected, especially in the 7/8 arm. This is a truly substantial reduction in acute GVHD risk in that patient population,” he said in an interview.
 

Could abatacept fuel greater use of mismatched, unrelated donors?

One downside of using an HLA-mismatched donor is the potential risk of developing aGVHD, Doris M. Ponce, MD, a hematologic oncologist with Memorial Sloan Kettering Cancer Center in New York, who was not involved with the research, said in an interview.

Potential risk factors for aGVHD include “having a female multiparous donor, HLA-mismatched donor, unrelated donor, donor and recipient age (>40 years), [peripheral blood stem cell] stem cell graft, recipient [cytomegalovirus] serostatus (recipient/donor), myeloablative conditioning, [total body irradiation]–based conditioning, [and] gut microbiome dysbiosis,” Dr. Ponce explained.

Abatacept’s approval may have particular relevance for people of color. “It’s been understood for a long time that the likelihood of finding an 8/8 well-matched, volunteer unrelated donor varies by race or ethnicity,” Steven Devine, MD, a board-certified oncologist who is chief medical officer of Be The Match and associate scientific director at CIBMTR, said in an interview.

Mr. Spellman noted that, of the more than 35 million donors on worldwide registries accessible through the National Marrow Donor Program’s Be The Match Registry, “the match rates differ quite substantially by race and ethnicity.” Approximately 29% of African Americans find a full match on the registry, compared with 81% of Whites, 49% of Hispanics, and 47% Asian/Pacific Islanders.

“Being able to utilize a 7/8 match in a safe, effective manner using abatacept, which abatacept has been approved for, does increase those match rates quite substantially,” he explained. Among African Americans, this means the match rate increases to 84%, among Hispanics and Asian/Pacific Islanders to approximately 90%, and among Whites to about 98%.

That kind of improvement in the match rate is “the equivalent of adding more than more than 10 million ethnically diverse donors to the registry in 1 day,” Dr. Devine said. “The availability of abatacept could really level the playing field for patients in need of a lifesaving transplant.”
 

Further study of abatacept

With abatacept, “I think the results are really encouraging, and I think that further studies [are needed] to better define how the drug would work and whether it can later prevent chronic graft versus host disease,” Dr. Devine said. He said the ABA3 trial has been designed around this question, with the hypothesis that extending abatacept to an eight-dose regimen may help with chronic GVHD.

Although the FDA’s approval of abatacept was recent, Mr. Spellman said, Be The Match has seen early indications that mismatched donors in the registry are being used, which may point to an increased utilization of abatacept. “Through October to December of 2021, there was a pretty substantial increase in the use of mismatched, unrelated donors in that time frame.”

Dr. Devine noted that he is seeing a lot of interest in using abatacept. “I think people are still learning how best to incorporate it into their standard of care right now.”

Meanwhile, Memorial Sloan Kettering Cancer Center is already planning to use abatacept, Dr. Ponce noted. “We have abatacept in our formulary for adult and children, and are planning on using it for patients receiving an unmodified graft from a [matched unrelated donor] or 1-allele [mismatched unrelated donor] using CNI and MTX-based GVHD prophylaxis.”

Dr. Devine and Mr. Spellman are employees of Be The Match and CIBMTR, which provided the registry control group for the ABA2 trial. Dr. Devine also reported that he has been a scientific advisory board member for Bristol-Myers Squibb. Dr. Ponce reports no relevant conflicts of interest.