In April 2021, Express Scripts stopped covering low-volume bowel preparations in its National Preferred Formulary, a move that had the potential to affect many of the 75 million Americans covered by that pharmacy benefit manager’s programs, according to the American Society for Gastrointestinal Endoscopy (ASGE).

For gastroenterologists and their patients, it was an action that added insult to injury. The COVID-19 pandemic had already led to shortages of various preps, causing many thousands of Americans to forego colonoscopies. One study estimated that there was a 95% decline in weekly colorectal cancer screenings in the first half of 2020.

Just as screenings were returning to prepandemic levels, the Express Scripts coverage change threatened to create a new barrier for those already hesitant, especially since the prep is what patients most loathe about colonoscopy, said the gastroenterologists interviewed for this story.

Almost a year later, not much has changed. Bowel prep shortages persist, and some insurers and pharmacy benefit management (PBM) companies are restricting coverage of certain prescription preps or instituting higher copays.

Gastroenterologists are having to delay procedures and patients are canceling appointments; some never return.

“I and many of my colleagues are very concerned that we are going to see an increase in advanced colon polyps and colon cancer,” said Jennifer A. Christie, MD, professor of medicine in the digestive diseases division at Emory University School of Medicine, Atlanta, and vice president of the ASGE.

Obstacles to getting the right prep “not only [delay] the care, but the negative outcomes could be horrible,” agreed Tauseef Ali, MD, clinical assistant professor at the University of Oklahoma and a member of the American College of Gastroenterology’s board of governors.

For the majority of patients, a wait might not be an issue, said Christian Stevoff, MD, assistant professor of medicine at Northwestern University Feinberg School of Medicine, Chicago. But a delayed diagnosis would be significant for those with larger polyps or cancer in the colon, he said.

“It’s a major problem for those people that it does affect,” Dr. Stevoff told this news organization.

He noted that his practice had to delay around 3,000 procedures in 2020, and while they have since caught up, approximately 25% of cases are being delayed right now for a variety of reasons. Most of those are in patients deemed to be low risk, though, he said.
 

PBMs: ‘a parasitic infection to our health care system’

Shortages of preps have been a persistent headache, but restrictions such as those instituted by Express Scripts have become a bigger problem, said some gastroenterologists.

Express Scripts did have several exceptions to its prohibition on coverage of low-volume preps. First, it could be approved if the patient had failed with a polyethylene glycol (PEG)–based prep like GoLYTELY. It could also be approved if the patient had tried MoviPrep and failed, if MoviPrep was unavailable, or if the patient has phenylketonuria or glucose-6-phosphate dehydrogenase deficiency.

Cigna-owned Express Scripts is one of three PBMs – along with CVS Caremark and OptumRX (owned by UnitedHealth Group) – that control 85% of prescription drug benefits in the United States, according to a 2019 investigation of the industry by the New York State Senate.

Express Scripts did not return requests for comment on its bowel prep coverage, and CVS Caremark declined to participate. A spokesperson for OptumRX told this news organization that the PBM provides bowel preps at “$0 cost-share” but only for health plan sponsors that are subject to Affordable Care Act regulations that require providing colonoscopies under such a payment structure. The company did not provide further information.

For some gastroenterologists, the anger toward PBMs is palpable. Dr. Ali calls PBMs “a parasitic infection to our health care system.”

“Keeping track of these bowel prep coverages has become a nightmare,” he said, noting that every payer seems to have its own preferred prep. “We have a dedicated nurse whose only job is to keep tabs on this, and she’s unable to because it’s just getting out of control.”

Some preps are contraindicated for patients, Dr. Ali said. Yet even in those cases, it’s difficult to get the alternatives covered. It often comes down to a joint effort by a pharmacist, the patient, and Dr. Ali’s office staff to get coverage for a medically necessary prep.

If it’s an emergency, Dr. Ali said, “either our patients bite the bullet and pay the price, or we have to come up with alternative solutions that may not lead to an optimal bowel preparation. It defeats the whole purpose of having a good bowel preparation and giving them a good outcome.”

He added that “there are a lot of patients who cancel their colonoscopies out of frustration,” because the bowel prep is not available or too expensive and that some patients choose to simply not reschedule.

Dr. Christie’s experience is similar. Sometimes patients must be rescheduled because “we could not get the prep in a timely fashion for them to be ready for their procedure.” Bringing back patients can be hard: They are busy, or they can’t get a ride, or time off work, or coverage for caregiving, she said. Ultimately, “some patients do decide to either defer or decline screening.”

The hassles also have the potential to exacerbate existing health disparities, she added.

Dr. Stevoff, the gastroenterologist at Northwestern, said cancellations are a concern, but to his knowledge, none of his patients have quit in frustration.

He said that because “most of the [preps] are equivalent to each other,” he often gives preference to what’s available.

He does tell patients that they may have a higher copay. For some that may be fine for what is only a once every 5- or 10-year payment. For others who cannot afford the cost, it may mean spending time trying to convince the insurer to pay for a prep that is not normally covered, he said.
 

A step backwards

Dr. Stevoff understands why payers might have preferred preps.

“As long as the outcomes are equivalent, I don’t think they’re going to be willing to pay for a prep that’s three or four times more expensive for a night of inconvenience for the patient,” he said.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, said he’s mystified by moves to limit bowel preps.

“Having to do an end-run to figure out what preps we can get for a patient is a step backwards,” he said.

Douglas Rex, MD, distinguished professor emeritus of medicine at Indiana University School of Medicine, Indianapolis, said it was dangerous to limit options.

“Trying to save relatively small amounts of money by restricting access to specific preps is seriously wrong-headed and a mistake,” he said. “If you keep the big picture in mind, we’re trying to keep people from getting colon cancer.”

Dr. Johnson also noted that a poor-quality prep might lead to a poor-quality exam, which is associated with not only reduced adenoma detection rates but also a shortened interval for a repeat exam, which just adds costs to the system.

“The whole impact of colon cancer screening is to discover polyps and remove them to prevent cancer,” Dr. Johnson said.
 

No rhyme or reason to ongoing shortages

Pandemic-related supply chain headaches have trickled down to bowel preps, which then lead to occasional delays in procedures.

“We have definitely seen shortages throughout most of the pandemic,” Dr. Rex said. At various times, he added, low-volume or high-volume prescription preps have not been available in all pharmacies or not available in certain pharmacies.

The spotty supplies have created a hassle and added costs because his office staff spends time making calls to find an available prep, he said.

Dr. Christie described similar issues at her practice, where the shortages have been “a significant challenge and issue.”

As of late January, some polyethylene glycol 3,350-based preps were still in short supply or had been discontinued, according to the American Society of Health-System Pharmacists (ASHP). Two companies – Teva and Lupin – did not provide a reason for the lack of product. However, ASHP said the companies anticipated being able to provide supplies in February.

Many PEG-based prescription products have been on back order for some time, said Dr. Johnson, who tries to avoid the higher-volume PEG-based preps in favor of low-volume preps that are more tolerable to patients.

The lack of information about a reason for the shortages has led to speculation.

At the beginning of the COVID-19 pandemic, GoLYTELY, one of the more commonly used PEG-based preps, was not available at all, Dr. Ali said. It was his understanding that PEG was being used as an ingredient in COVID vaccines, which helped explain the shortage, at least initially.

Dr. Stevoff also heard this explanation but said he had come to believe it was an “urban myth,” and added that he “never got confirmation from any of the companies” that they couldn’t get PEG because it was being used for vaccines. He noted that shortages of some PEG-based preps have continued even though vaccine production has stabilized.
 

Over-the-counter alternatives can be ‘hit or miss’

With the price for all bowel preps – and co-pays – increasing in the last 2 years, some practices are directing patients on how to mix up their own using over-the-counter (OTC) ingredients, which is likely to be less expensive.

The out-of-pocket cost for a four-liter, high-volume PEG-based prep might be $35-$50, according to GoodRx. Alternatives such as Suprep (sodium/potassium/magnesium) run $110-$120, according to the website, and a sodium phosphate-based prep, such as OsmoPrep, runs close to $300.

The OTC prep uses MiraLAX (PEG-based but without additional electrolytes mixed in) and bisacodyl (Dulcolax). Johns Hopkins University, Cleveland Clinic, and Memorial Sloan Kettering, among many other institutions, have advised patients to use the OTC do-it-yourself preps. It is a split prep, using 238 grams of MiraLAX mixed with 64 ounces of water or a sports drink (for example, Gatorade). The day before the procedure, patients take 2 bisacodyl (5 mg) tablets, followed by four 8-ounce glasses of a MiraLAX/water mixture. The same regimen is followed the day of the procedure.

There are mixed results on how adequately the regimen cleans the colon. A 2014 meta-analysis found that the MiraLAX-based prep was inferior in terms of bowel cleansing to PEG-based formulations premixed with electrolyte solutions (PEG-ELS). There was no statistically significant difference in polyp detection between the two. In a 2011 analysis, researchers concluded that GoLYTELY was superior to MiraLAX in colon prep and adenoma detection.

The 2014 U.S. Multi-Society Task Force on Colorectal Cancer Guidelines reported that the MiraLAX-based prep had less effective bowel preparation than 4-liter PEG-ELS solutions in at least one study but that it appeared to be more tolerable for patients and associated with few adverse events. More study of its safety is “warranted and desirable,” write the authors.

Even before the pandemic, Dr. Rex said his practice used the MiraLAX-based prep because it was less expensive, and “anecdotally it tends to be very well tolerated.”

However, he noted that the regimen is not approved by the Food and Drug Administration.

“A lot of people don’t like to use non–FDA approved preps because they’re afraid of some liability if there is a complication,” Dr. Rex said.

Dr. Ali added that he has advised patients to use the OTC preps, but the results can be “hit or miss.”

Some patients can easily comply with the instructions and will have good results, but others may not have the education or understanding or may have underlying medical conditions that lessen the OTC formulation’s effectiveness in getting a good cleanout, said Dr. Ali.

Dr. Stevoff has occasionally used the OTC prep but agrees that not all patients will be able to follow the directions.

“The more complicated a process is, the more likely it is that somebody will make a mistake,” he said.

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

In April 2021, Express Scripts stopped covering low-volume bowel preparations in its National Preferred Formulary, a move that had the potential to affect many of the 75 million Americans covered by that pharmacy benefit manager’s programs, according to the American Society for Gastrointestinal Endoscopy (ASGE).

For gastroenterologists and their patients, it was an action that added insult to injury. The COVID-19 pandemic had already led to shortages of various preps, causing many thousands of Americans to forego colonoscopies. One study estimated that there was a 95% decline in weekly colorectal cancer screenings in the first half of 2020.

Just as screenings were returning to prepandemic levels, the Express Scripts coverage change threatened to create a new barrier for those already hesitant, especially since the prep is what patients most loathe about colonoscopy, said the gastroenterologists interviewed for this story.

Almost a year later, not much has changed. Bowel prep shortages persist, and some insurers and pharmacy benefit management (PBM) companies are restricting coverage of certain prescription preps or instituting higher copays.

Gastroenterologists are having to delay procedures and patients are canceling appointments; some never return.

“I and many of my colleagues are very concerned that we are going to see an increase in advanced colon polyps and colon cancer,” said Jennifer A. Christie, MD, professor of medicine in the digestive diseases division at Emory University School of Medicine, Atlanta, and vice president of the ASGE.

Obstacles to getting the right prep “not only [delay] the care, but the negative outcomes could be horrible,” agreed Tauseef Ali, MD, clinical assistant professor at the University of Oklahoma and a member of the American College of Gastroenterology’s board of governors.

For the majority of patients, a wait might not be an issue, said Christian Stevoff, MD, assistant professor of medicine at Northwestern University Feinberg School of Medicine, Chicago. But a delayed diagnosis would be significant for those with larger polyps or cancer in the colon, he said.

“It’s a major problem for those people that it does affect,” Dr. Stevoff told this news organization.

He noted that his practice had to delay around 3,000 procedures in 2020, and while they have since caught up, approximately 25% of cases are being delayed right now for a variety of reasons. Most of those are in patients deemed to be low risk, though, he said.
 

PBMs: ‘a parasitic infection to our health care system’

Shortages of preps have been a persistent headache, but restrictions such as those instituted by Express Scripts have become a bigger problem, said some gastroenterologists.

Express Scripts did have several exceptions to its prohibition on coverage of low-volume preps. First, it could be approved if the patient had failed with a polyethylene glycol (PEG)–based prep like GoLYTELY. It could also be approved if the patient had tried MoviPrep and failed, if MoviPrep was unavailable, or if the patient has phenylketonuria or glucose-6-phosphate dehydrogenase deficiency.

Cigna-owned Express Scripts is one of three PBMs – along with CVS Caremark and OptumRX (owned by UnitedHealth Group) – that control 85% of prescription drug benefits in the United States, according to a 2019 investigation of the industry by the New York State Senate.

Express Scripts did not return requests for comment on its bowel prep coverage, and CVS Caremark declined to participate. A spokesperson for OptumRX told this news organization that the PBM provides bowel preps at “$0 cost-share” but only for health plan sponsors that are subject to Affordable Care Act regulations that require providing colonoscopies under such a payment structure. The company did not provide further information.

For some gastroenterologists, the anger toward PBMs is palpable. Dr. Ali calls PBMs “a parasitic infection to our health care system.”

“Keeping track of these bowel prep coverages has become a nightmare,” he said, noting that every payer seems to have its own preferred prep. “We have a dedicated nurse whose only job is to keep tabs on this, and she’s unable to because it’s just getting out of control.”

Some preps are contraindicated for patients, Dr. Ali said. Yet even in those cases, it’s difficult to get the alternatives covered. It often comes down to a joint effort by a pharmacist, the patient, and Dr. Ali’s office staff to get coverage for a medically necessary prep.

If it’s an emergency, Dr. Ali said, “either our patients bite the bullet and pay the price, or we have to come up with alternative solutions that may not lead to an optimal bowel preparation. It defeats the whole purpose of having a good bowel preparation and giving them a good outcome.”

He added that “there are a lot of patients who cancel their colonoscopies out of frustration,” because the bowel prep is not available or too expensive and that some patients choose to simply not reschedule.

Dr. Christie’s experience is similar. Sometimes patients must be rescheduled because “we could not get the prep in a timely fashion for them to be ready for their procedure.” Bringing back patients can be hard: They are busy, or they can’t get a ride, or time off work, or coverage for caregiving, she said. Ultimately, “some patients do decide to either defer or decline screening.”

The hassles also have the potential to exacerbate existing health disparities, she added.

Dr. Stevoff, the gastroenterologist at Northwestern, said cancellations are a concern, but to his knowledge, none of his patients have quit in frustration.

He said that because “most of the [preps] are equivalent to each other,” he often gives preference to what’s available.

He does tell patients that they may have a higher copay. For some that may be fine for what is only a once every 5- or 10-year payment. For others who cannot afford the cost, it may mean spending time trying to convince the insurer to pay for a prep that is not normally covered, he said.
 

A step backwards

Dr. Stevoff understands why payers might have preferred preps.

“As long as the outcomes are equivalent, I don’t think they’re going to be willing to pay for a prep that’s three or four times more expensive for a night of inconvenience for the patient,” he said.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, said he’s mystified by moves to limit bowel preps.

“Having to do an end-run to figure out what preps we can get for a patient is a step backwards,” he said.

Douglas Rex, MD, distinguished professor emeritus of medicine at Indiana University School of Medicine, Indianapolis, said it was dangerous to limit options.

“Trying to save relatively small amounts of money by restricting access to specific preps is seriously wrong-headed and a mistake,” he said. “If you keep the big picture in mind, we’re trying to keep people from getting colon cancer.”

Dr. Johnson also noted that a poor-quality prep might lead to a poor-quality exam, which is associated with not only reduced adenoma detection rates but also a shortened interval for a repeat exam, which just adds costs to the system.

“The whole impact of colon cancer screening is to discover polyps and remove them to prevent cancer,” Dr. Johnson said.
 

No rhyme or reason to ongoing shortages

Pandemic-related supply chain headaches have trickled down to bowel preps, which then lead to occasional delays in procedures.

“We have definitely seen shortages throughout most of the pandemic,” Dr. Rex said. At various times, he added, low-volume or high-volume prescription preps have not been available in all pharmacies or not available in certain pharmacies.

The spotty supplies have created a hassle and added costs because his office staff spends time making calls to find an available prep, he said.

Dr. Christie described similar issues at her practice, where the shortages have been “a significant challenge and issue.”

As of late January, some polyethylene glycol 3,350-based preps were still in short supply or had been discontinued, according to the American Society of Health-System Pharmacists (ASHP). Two companies – Teva and Lupin – did not provide a reason for the lack of product. However, ASHP said the companies anticipated being able to provide supplies in February.

Many PEG-based prescription products have been on back order for some time, said Dr. Johnson, who tries to avoid the higher-volume PEG-based preps in favor of low-volume preps that are more tolerable to patients.

The lack of information about a reason for the shortages has led to speculation.

At the beginning of the COVID-19 pandemic, GoLYTELY, one of the more commonly used PEG-based preps, was not available at all, Dr. Ali said. It was his understanding that PEG was being used as an ingredient in COVID vaccines, which helped explain the shortage, at least initially.

Dr. Stevoff also heard this explanation but said he had come to believe it was an “urban myth,” and added that he “never got confirmation from any of the companies” that they couldn’t get PEG because it was being used for vaccines. He noted that shortages of some PEG-based preps have continued even though vaccine production has stabilized.
 

Over-the-counter alternatives can be ‘hit or miss’

With the price for all bowel preps – and co-pays – increasing in the last 2 years, some practices are directing patients on how to mix up their own using over-the-counter (OTC) ingredients, which is likely to be less expensive.

The out-of-pocket cost for a four-liter, high-volume PEG-based prep might be $35-$50, according to GoodRx. Alternatives such as Suprep (sodium/potassium/magnesium) run $110-$120, according to the website, and a sodium phosphate-based prep, such as OsmoPrep, runs close to $300.

The OTC prep uses MiraLAX (PEG-based but without additional electrolytes mixed in) and bisacodyl (Dulcolax). Johns Hopkins University, Cleveland Clinic, and Memorial Sloan Kettering, among many other institutions, have advised patients to use the OTC do-it-yourself preps. It is a split prep, using 238 grams of MiraLAX mixed with 64 ounces of water or a sports drink (for example, Gatorade). The day before the procedure, patients take 2 bisacodyl (5 mg) tablets, followed by four 8-ounce glasses of a MiraLAX/water mixture. The same regimen is followed the day of the procedure.

There are mixed results on how adequately the regimen cleans the colon. A 2014 meta-analysis found that the MiraLAX-based prep was inferior in terms of bowel cleansing to PEG-based formulations premixed with electrolyte solutions (PEG-ELS). There was no statistically significant difference in polyp detection between the two. In a 2011 analysis, researchers concluded that GoLYTELY was superior to MiraLAX in colon prep and adenoma detection.

The 2014 U.S. Multi-Society Task Force on Colorectal Cancer Guidelines reported that the MiraLAX-based prep had less effective bowel preparation than 4-liter PEG-ELS solutions in at least one study but that it appeared to be more tolerable for patients and associated with few adverse events. More study of its safety is “warranted and desirable,” write the authors.

Even before the pandemic, Dr. Rex said his practice used the MiraLAX-based prep because it was less expensive, and “anecdotally it tends to be very well tolerated.”

However, he noted that the regimen is not approved by the Food and Drug Administration.

“A lot of people don’t like to use non–FDA approved preps because they’re afraid of some liability if there is a complication,” Dr. Rex said.

Dr. Ali added that he has advised patients to use the OTC preps, but the results can be “hit or miss.”

Some patients can easily comply with the instructions and will have good results, but others may not have the education or understanding or may have underlying medical conditions that lessen the OTC formulation’s effectiveness in getting a good cleanout, said Dr. Ali.

Dr. Stevoff has occasionally used the OTC prep but agrees that not all patients will be able to follow the directions.

“The more complicated a process is, the more likely it is that somebody will make a mistake,” he said.

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

In April 2021, Express Scripts stopped covering low-volume bowel preparations in its National Preferred Formulary, a move that had the potential to affect many of the 75 million Americans covered by that pharmacy benefit manager’s programs, according to the American Society for Gastrointestinal Endoscopy (ASGE).

For gastroenterologists and their patients, it was an action that added insult to injury. The COVID-19 pandemic had already led to shortages of various preps, causing many thousands of Americans to forego colonoscopies. One study estimated that there was a 95% decline in weekly colorectal cancer screenings in the first half of 2020.

Just as screenings were returning to prepandemic levels, the Express Scripts coverage change threatened to create a new barrier for those already hesitant, especially since the prep is what patients most loathe about colonoscopy, said the gastroenterologists interviewed for this story.

Almost a year later, not much has changed. Bowel prep shortages persist, and some insurers and pharmacy benefit management (PBM) companies are restricting coverage of certain prescription preps or instituting higher copays.

Gastroenterologists are having to delay procedures and patients are canceling appointments; some never return.

“I and many of my colleagues are very concerned that we are going to see an increase in advanced colon polyps and colon cancer,” said Jennifer A. Christie, MD, professor of medicine in the digestive diseases division at Emory University School of Medicine, Atlanta, and vice president of the ASGE.

Obstacles to getting the right prep “not only [delay] the care, but the negative outcomes could be horrible,” agreed Tauseef Ali, MD, clinical assistant professor at the University of Oklahoma and a member of the American College of Gastroenterology’s board of governors.

For the majority of patients, a wait might not be an issue, said Christian Stevoff, MD, assistant professor of medicine at Northwestern University Feinberg School of Medicine, Chicago. But a delayed diagnosis would be significant for those with larger polyps or cancer in the colon, he said.

“It’s a major problem for those people that it does affect,” Dr. Stevoff told this news organization.

He noted that his practice had to delay around 3,000 procedures in 2020, and while they have since caught up, approximately 25% of cases are being delayed right now for a variety of reasons. Most of those are in patients deemed to be low risk, though, he said.
 

PBMs: ‘a parasitic infection to our health care system’

Shortages of preps have been a persistent headache, but restrictions such as those instituted by Express Scripts have become a bigger problem, said some gastroenterologists.

Express Scripts did have several exceptions to its prohibition on coverage of low-volume preps. First, it could be approved if the patient had failed with a polyethylene glycol (PEG)–based prep like GoLYTELY. It could also be approved if the patient had tried MoviPrep and failed, if MoviPrep was unavailable, or if the patient has phenylketonuria or glucose-6-phosphate dehydrogenase deficiency.

Cigna-owned Express Scripts is one of three PBMs – along with CVS Caremark and OptumRX (owned by UnitedHealth Group) – that control 85% of prescription drug benefits in the United States, according to a 2019 investigation of the industry by the New York State Senate.

Express Scripts did not return requests for comment on its bowel prep coverage, and CVS Caremark declined to participate. A spokesperson for OptumRX told this news organization that the PBM provides bowel preps at “$0 cost-share” but only for health plan sponsors that are subject to Affordable Care Act regulations that require providing colonoscopies under such a payment structure. The company did not provide further information.

For some gastroenterologists, the anger toward PBMs is palpable. Dr. Ali calls PBMs “a parasitic infection to our health care system.”

“Keeping track of these bowel prep coverages has become a nightmare,” he said, noting that every payer seems to have its own preferred prep. “We have a dedicated nurse whose only job is to keep tabs on this, and she’s unable to because it’s just getting out of control.”

Some preps are contraindicated for patients, Dr. Ali said. Yet even in those cases, it’s difficult to get the alternatives covered. It often comes down to a joint effort by a pharmacist, the patient, and Dr. Ali’s office staff to get coverage for a medically necessary prep.

If it’s an emergency, Dr. Ali said, “either our patients bite the bullet and pay the price, or we have to come up with alternative solutions that may not lead to an optimal bowel preparation. It defeats the whole purpose of having a good bowel preparation and giving them a good outcome.”

He added that “there are a lot of patients who cancel their colonoscopies out of frustration,” because the bowel prep is not available or too expensive and that some patients choose to simply not reschedule.

Dr. Christie’s experience is similar. Sometimes patients must be rescheduled because “we could not get the prep in a timely fashion for them to be ready for their procedure.” Bringing back patients can be hard: They are busy, or they can’t get a ride, or time off work, or coverage for caregiving, she said. Ultimately, “some patients do decide to either defer or decline screening.”

The hassles also have the potential to exacerbate existing health disparities, she added.

Dr. Stevoff, the gastroenterologist at Northwestern, said cancellations are a concern, but to his knowledge, none of his patients have quit in frustration.

He said that because “most of the [preps] are equivalent to each other,” he often gives preference to what’s available.

He does tell patients that they may have a higher copay. For some that may be fine for what is only a once every 5- or 10-year payment. For others who cannot afford the cost, it may mean spending time trying to convince the insurer to pay for a prep that is not normally covered, he said.
 

A step backwards

Dr. Stevoff understands why payers might have preferred preps.

“As long as the outcomes are equivalent, I don’t think they’re going to be willing to pay for a prep that’s three or four times more expensive for a night of inconvenience for the patient,” he said.

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, said he’s mystified by moves to limit bowel preps.

“Having to do an end-run to figure out what preps we can get for a patient is a step backwards,” he said.

Douglas Rex, MD, distinguished professor emeritus of medicine at Indiana University School of Medicine, Indianapolis, said it was dangerous to limit options.

“Trying to save relatively small amounts of money by restricting access to specific preps is seriously wrong-headed and a mistake,” he said. “If you keep the big picture in mind, we’re trying to keep people from getting colon cancer.”

Dr. Johnson also noted that a poor-quality prep might lead to a poor-quality exam, which is associated with not only reduced adenoma detection rates but also a shortened interval for a repeat exam, which just adds costs to the system.

“The whole impact of colon cancer screening is to discover polyps and remove them to prevent cancer,” Dr. Johnson said.
 

No rhyme or reason to ongoing shortages

Pandemic-related supply chain headaches have trickled down to bowel preps, which then lead to occasional delays in procedures.

“We have definitely seen shortages throughout most of the pandemic,” Dr. Rex said. At various times, he added, low-volume or high-volume prescription preps have not been available in all pharmacies or not available in certain pharmacies.

The spotty supplies have created a hassle and added costs because his office staff spends time making calls to find an available prep, he said.

Dr. Christie described similar issues at her practice, where the shortages have been “a significant challenge and issue.”

As of late January, some polyethylene glycol 3,350-based preps were still in short supply or had been discontinued, according to the American Society of Health-System Pharmacists (ASHP). Two companies – Teva and Lupin – did not provide a reason for the lack of product. However, ASHP said the companies anticipated being able to provide supplies in February.

Many PEG-based prescription products have been on back order for some time, said Dr. Johnson, who tries to avoid the higher-volume PEG-based preps in favor of low-volume preps that are more tolerable to patients.

The lack of information about a reason for the shortages has led to speculation.

At the beginning of the COVID-19 pandemic, GoLYTELY, one of the more commonly used PEG-based preps, was not available at all, Dr. Ali said. It was his understanding that PEG was being used as an ingredient in COVID vaccines, which helped explain the shortage, at least initially.

Dr. Stevoff also heard this explanation but said he had come to believe it was an “urban myth,” and added that he “never got confirmation from any of the companies” that they couldn’t get PEG because it was being used for vaccines. He noted that shortages of some PEG-based preps have continued even though vaccine production has stabilized.
 

Over-the-counter alternatives can be ‘hit or miss’

With the price for all bowel preps – and co-pays – increasing in the last 2 years, some practices are directing patients on how to mix up their own using over-the-counter (OTC) ingredients, which is likely to be less expensive.

The out-of-pocket cost for a four-liter, high-volume PEG-based prep might be $35-$50, according to GoodRx. Alternatives such as Suprep (sodium/potassium/magnesium) run $110-$120, according to the website, and a sodium phosphate-based prep, such as OsmoPrep, runs close to $300.

The OTC prep uses MiraLAX (PEG-based but without additional electrolytes mixed in) and bisacodyl (Dulcolax). Johns Hopkins University, Cleveland Clinic, and Memorial Sloan Kettering, among many other institutions, have advised patients to use the OTC do-it-yourself preps. It is a split prep, using 238 grams of MiraLAX mixed with 64 ounces of water or a sports drink (for example, Gatorade). The day before the procedure, patients take 2 bisacodyl (5 mg) tablets, followed by four 8-ounce glasses of a MiraLAX/water mixture. The same regimen is followed the day of the procedure.

There are mixed results on how adequately the regimen cleans the colon. A 2014 meta-analysis found that the MiraLAX-based prep was inferior in terms of bowel cleansing to PEG-based formulations premixed with electrolyte solutions (PEG-ELS). There was no statistically significant difference in polyp detection between the two. In a 2011 analysis, researchers concluded that GoLYTELY was superior to MiraLAX in colon prep and adenoma detection.

The 2014 U.S. Multi-Society Task Force on Colorectal Cancer Guidelines reported that the MiraLAX-based prep had less effective bowel preparation than 4-liter PEG-ELS solutions in at least one study but that it appeared to be more tolerable for patients and associated with few adverse events. More study of its safety is “warranted and desirable,” write the authors.

Even before the pandemic, Dr. Rex said his practice used the MiraLAX-based prep because it was less expensive, and “anecdotally it tends to be very well tolerated.”

However, he noted that the regimen is not approved by the Food and Drug Administration.

“A lot of people don’t like to use non–FDA approved preps because they’re afraid of some liability if there is a complication,” Dr. Rex said.

Dr. Ali added that he has advised patients to use the OTC preps, but the results can be “hit or miss.”

Some patients can easily comply with the instructions and will have good results, but others may not have the education or understanding or may have underlying medical conditions that lessen the OTC formulation’s effectiveness in getting a good cleanout, said Dr. Ali.

Dr. Stevoff has occasionally used the OTC prep but agrees that not all patients will be able to follow the directions.

“The more complicated a process is, the more likely it is that somebody will make a mistake,” he said.

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

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

A Pennsylvania physician claims that an attorney who cried during testimony unfairly tainted his malpractice trial and led to a $1.3 million jury award against him.

Jurors found obstetrician-gynecologist Charles H. Marks, DO, negligent for failing to follow up on a patient’s complex cyst and hyperechoic nodule, which resulted in a delayed ovarian cancer diagnosis. But during the doctor’s 4-day trial, several parties had emotional outbursts in front of the jury, including the plaintiff’s’ attorney, a physician expert witness, the patient, and a family member.

According to trial transcripts, a gynecologic oncologist expert began crying on the stand after providing a clinical description of the symptoms that plaintiff, Chasidy Plunkard, would probably experience leading up to her death. When asked how long the patient had to live, the oncologist said “months” and later added, “I think she is living for this trial.”

After these comments, Ms. Plunkard’s attorney, Kila Baldwin, also began crying and requested a break to regain her composure, according to district court documents. During the 3 minutes the attorney was gone, the courtroom was silent other than the sound of Ms. Plunkard and her cousin sobbing.

The following day, U.S. District Judge Jennifer P. Wilson warned Ms. Baldwin that she would consider declaring a mistrial if the outburst happened again, according to trial transcripts.

“I expect counsel to maintain a professional demeanor even when eliciting emotionally laden testimony,” Judge Wilson said. “…I will not allow another recess. Further, if we have another incident like we had yesterday, I would have to entertain, if a motion for mistrial is made, I would have to seriously consider that, because I am concerned that this jury already has had a demonstration of a level of emotion that may make it difficult for them to set that aside and render a verdict that’s based only on a dispassionate consideration of what I perceive to be a legitimate dispute regarding liability.”

Judge Wilson later instructed jurors to disregard certain testimony at the request of Dr. Marks’ attorneys and reminded them not to be influenced by sympathy. After jurors rendered their $1.3 million verdict against Dr. Marks, he requested a new trial, claiming the witness’s testimony and the emotional displays of the witness and the attorney unfairly influenced the jury.

The expert witness “and plaintiff’s counsel undoubtedly affected the jury’s ability to decide this case in a dispassionate and impartial way and denied Dr. Marks his right to a fair trial,” attorney Matthew Rappleye wrote in Dr. Marks’ motion for a retrial. “Just as the court feared, as a result of these events, the jury was ‘tainted’ and could no longer decide this case divorced of sympathy for Ms. Plunkard.”

In response, an attorney for Ms. Plunkard emphasized that Dr. Marks did not request a retrial during the trial and that he was granted objections to the relevant testimony that he sought.

“In any event, the jury had the benefit of substantial evidence concerning Dr. Marks’ negligence, and the jury was entitled to construe that evidence in Plaintiff’s favor” attorney Charles Becker wrote. “…Indeed, the jury’s economic damages award of $585,000 not only fell well below the projection of plaintiff’s expert, but also ran at the low-end of the projection provided by Defendant’s economist. As to the non-economic damages, the jury’s award of $750,000 could have been far higher…. Nothing about either verdict or the damages award suggests a jury that was influenced by impermissible displays of emotion by the trial participants.”

In a December 13, 2021, decision, the U.S. District Court for the Middle District Court of Pennsylvania denied Dr. Marks’ request for a retrial. In her decision, Judge Wilson wrote that nothing in the jury’s verdict appeared to indicate that jurors were swayed by sympathy and that the verdict appeared to be conservative in light of the testimony presented.

Attorneys for Dr. Marks did not respond to a request for comment. In a statement, Ms. Baldwin said that the judge’s decision was correct.

“The district court got it exactly right, and we look forward to Ms. Plunkard receiving the compensation awarded by the jury in this tragic case,” she said.
 

Why did the patient sue?

Ms. Plunkard’s lawsuit against Dr. Marks stemmed from a January 2016 visit for complaints of bloating, pelvic pain, irregular periods, and an abnormal pelvic ultrasound. The ultrasound, ordered by her primary care physician, showed a thickened endometrial lining; a normal left ovary; and an enlarged, abnormal right ovary containing a complicated cyst, according to Ms. Plunkard’s complaint. Dr. Marks performed an endometrial biopsy and advised Ms. Plunkard that she would not need to take further measures if the result was benign, according to her lawsuit.

The result was benign, so Ms. Plunkard said she sought no further treatment for the cyst and none of her treating physicians followed up on the cyst. In February 2017, Ms. Plunkard presented to an emergency department with severe right upper quadrant abdominal pain and an ultrasound showed possible gallstones and pleural effusion, according to court documents.

After laparoscopic cholecystectomy, it was discovered that Ms. Plunkard had an inflamed pelvis and an omental lymph node was removed and biopsied. Surgeons reported that the lymph node showed metastatic cancer of probable gynecologic origin.

The patient underwent exploratory laparotomy, resulting in a radical abdominal hysterectomy, appendectomy, resection of the rectosigmoid with end-to-end anastomosis, and removal of cancerous implants. She was ultimately diagnosed with stage IVB low-grade metastatic ovarian cancer and went through six chemotherapy courses.

The patent’s cancer briefly went into remission but returned. In her complaint, Ms. Plunkard said Dr. Marks’ negligence allowed the cancer to spread from stage I to stage IVB, increasing her risk for harm and untimely death.

Dr. Marks argued that a follow-up ultrasound was not required, that the cyst on the patient’s right ovary was benign and resolved itself, that Ms. Plunkard’s cancer originated on the left, and that a follow-up ultrasound would not have detected primary cancer on the left ovary, according to legal documents.

On January 7, 2022, Dr. Marks appealed the jury’s verdict and the order denying his request for a retrial to the U.S. Court of Appeals for the Third Circuit.

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

A Pennsylvania physician claims that an attorney who cried during testimony unfairly tainted his malpractice trial and led to a $1.3 million jury award against him.

Jurors found obstetrician-gynecologist Charles H. Marks, DO, negligent for failing to follow up on a patient’s complex cyst and hyperechoic nodule, which resulted in a delayed ovarian cancer diagnosis. But during the doctor’s 4-day trial, several parties had emotional outbursts in front of the jury, including the plaintiff’s’ attorney, a physician expert witness, the patient, and a family member.

According to trial transcripts, a gynecologic oncologist expert began crying on the stand after providing a clinical description of the symptoms that plaintiff, Chasidy Plunkard, would probably experience leading up to her death. When asked how long the patient had to live, the oncologist said “months” and later added, “I think she is living for this trial.”

After these comments, Ms. Plunkard’s attorney, Kila Baldwin, also began crying and requested a break to regain her composure, according to district court documents. During the 3 minutes the attorney was gone, the courtroom was silent other than the sound of Ms. Plunkard and her cousin sobbing.

The following day, U.S. District Judge Jennifer P. Wilson warned Ms. Baldwin that she would consider declaring a mistrial if the outburst happened again, according to trial transcripts.

“I expect counsel to maintain a professional demeanor even when eliciting emotionally laden testimony,” Judge Wilson said. “…I will not allow another recess. Further, if we have another incident like we had yesterday, I would have to entertain, if a motion for mistrial is made, I would have to seriously consider that, because I am concerned that this jury already has had a demonstration of a level of emotion that may make it difficult for them to set that aside and render a verdict that’s based only on a dispassionate consideration of what I perceive to be a legitimate dispute regarding liability.”

Judge Wilson later instructed jurors to disregard certain testimony at the request of Dr. Marks’ attorneys and reminded them not to be influenced by sympathy. After jurors rendered their $1.3 million verdict against Dr. Marks, he requested a new trial, claiming the witness’s testimony and the emotional displays of the witness and the attorney unfairly influenced the jury.

The expert witness “and plaintiff’s counsel undoubtedly affected the jury’s ability to decide this case in a dispassionate and impartial way and denied Dr. Marks his right to a fair trial,” attorney Matthew Rappleye wrote in Dr. Marks’ motion for a retrial. “Just as the court feared, as a result of these events, the jury was ‘tainted’ and could no longer decide this case divorced of sympathy for Ms. Plunkard.”

In response, an attorney for Ms. Plunkard emphasized that Dr. Marks did not request a retrial during the trial and that he was granted objections to the relevant testimony that he sought.

“In any event, the jury had the benefit of substantial evidence concerning Dr. Marks’ negligence, and the jury was entitled to construe that evidence in Plaintiff’s favor” attorney Charles Becker wrote. “…Indeed, the jury’s economic damages award of $585,000 not only fell well below the projection of plaintiff’s expert, but also ran at the low-end of the projection provided by Defendant’s economist. As to the non-economic damages, the jury’s award of $750,000 could have been far higher…. Nothing about either verdict or the damages award suggests a jury that was influenced by impermissible displays of emotion by the trial participants.”

In a December 13, 2021, decision, the U.S. District Court for the Middle District Court of Pennsylvania denied Dr. Marks’ request for a retrial. In her decision, Judge Wilson wrote that nothing in the jury’s verdict appeared to indicate that jurors were swayed by sympathy and that the verdict appeared to be conservative in light of the testimony presented.

Attorneys for Dr. Marks did not respond to a request for comment. In a statement, Ms. Baldwin said that the judge’s decision was correct.

“The district court got it exactly right, and we look forward to Ms. Plunkard receiving the compensation awarded by the jury in this tragic case,” she said.
 

Why did the patient sue?

Ms. Plunkard’s lawsuit against Dr. Marks stemmed from a January 2016 visit for complaints of bloating, pelvic pain, irregular periods, and an abnormal pelvic ultrasound. The ultrasound, ordered by her primary care physician, showed a thickened endometrial lining; a normal left ovary; and an enlarged, abnormal right ovary containing a complicated cyst, according to Ms. Plunkard’s complaint. Dr. Marks performed an endometrial biopsy and advised Ms. Plunkard that she would not need to take further measures if the result was benign, according to her lawsuit.

The result was benign, so Ms. Plunkard said she sought no further treatment for the cyst and none of her treating physicians followed up on the cyst. In February 2017, Ms. Plunkard presented to an emergency department with severe right upper quadrant abdominal pain and an ultrasound showed possible gallstones and pleural effusion, according to court documents.

After laparoscopic cholecystectomy, it was discovered that Ms. Plunkard had an inflamed pelvis and an omental lymph node was removed and biopsied. Surgeons reported that the lymph node showed metastatic cancer of probable gynecologic origin.

The patient underwent exploratory laparotomy, resulting in a radical abdominal hysterectomy, appendectomy, resection of the rectosigmoid with end-to-end anastomosis, and removal of cancerous implants. She was ultimately diagnosed with stage IVB low-grade metastatic ovarian cancer and went through six chemotherapy courses.

The patent’s cancer briefly went into remission but returned. In her complaint, Ms. Plunkard said Dr. Marks’ negligence allowed the cancer to spread from stage I to stage IVB, increasing her risk for harm and untimely death.

Dr. Marks argued that a follow-up ultrasound was not required, that the cyst on the patient’s right ovary was benign and resolved itself, that Ms. Plunkard’s cancer originated on the left, and that a follow-up ultrasound would not have detected primary cancer on the left ovary, according to legal documents.

On January 7, 2022, Dr. Marks appealed the jury’s verdict and the order denying his request for a retrial to the U.S. Court of Appeals for the Third Circuit.

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

A Pennsylvania physician claims that an attorney who cried during testimony unfairly tainted his malpractice trial and led to a $1.3 million jury award against him.

Jurors found obstetrician-gynecologist Charles H. Marks, DO, negligent for failing to follow up on a patient’s complex cyst and hyperechoic nodule, which resulted in a delayed ovarian cancer diagnosis. But during the doctor’s 4-day trial, several parties had emotional outbursts in front of the jury, including the plaintiff’s’ attorney, a physician expert witness, the patient, and a family member.

According to trial transcripts, a gynecologic oncologist expert began crying on the stand after providing a clinical description of the symptoms that plaintiff, Chasidy Plunkard, would probably experience leading up to her death. When asked how long the patient had to live, the oncologist said “months” and later added, “I think she is living for this trial.”

After these comments, Ms. Plunkard’s attorney, Kila Baldwin, also began crying and requested a break to regain her composure, according to district court documents. During the 3 minutes the attorney was gone, the courtroom was silent other than the sound of Ms. Plunkard and her cousin sobbing.

The following day, U.S. District Judge Jennifer P. Wilson warned Ms. Baldwin that she would consider declaring a mistrial if the outburst happened again, according to trial transcripts.

“I expect counsel to maintain a professional demeanor even when eliciting emotionally laden testimony,” Judge Wilson said. “…I will not allow another recess. Further, if we have another incident like we had yesterday, I would have to entertain, if a motion for mistrial is made, I would have to seriously consider that, because I am concerned that this jury already has had a demonstration of a level of emotion that may make it difficult for them to set that aside and render a verdict that’s based only on a dispassionate consideration of what I perceive to be a legitimate dispute regarding liability.”

Judge Wilson later instructed jurors to disregard certain testimony at the request of Dr. Marks’ attorneys and reminded them not to be influenced by sympathy. After jurors rendered their $1.3 million verdict against Dr. Marks, he requested a new trial, claiming the witness’s testimony and the emotional displays of the witness and the attorney unfairly influenced the jury.

The expert witness “and plaintiff’s counsel undoubtedly affected the jury’s ability to decide this case in a dispassionate and impartial way and denied Dr. Marks his right to a fair trial,” attorney Matthew Rappleye wrote in Dr. Marks’ motion for a retrial. “Just as the court feared, as a result of these events, the jury was ‘tainted’ and could no longer decide this case divorced of sympathy for Ms. Plunkard.”

In response, an attorney for Ms. Plunkard emphasized that Dr. Marks did not request a retrial during the trial and that he was granted objections to the relevant testimony that he sought.

“In any event, the jury had the benefit of substantial evidence concerning Dr. Marks’ negligence, and the jury was entitled to construe that evidence in Plaintiff’s favor” attorney Charles Becker wrote. “…Indeed, the jury’s economic damages award of $585,000 not only fell well below the projection of plaintiff’s expert, but also ran at the low-end of the projection provided by Defendant’s economist. As to the non-economic damages, the jury’s award of $750,000 could have been far higher…. Nothing about either verdict or the damages award suggests a jury that was influenced by impermissible displays of emotion by the trial participants.”

In a December 13, 2021, decision, the U.S. District Court for the Middle District Court of Pennsylvania denied Dr. Marks’ request for a retrial. In her decision, Judge Wilson wrote that nothing in the jury’s verdict appeared to indicate that jurors were swayed by sympathy and that the verdict appeared to be conservative in light of the testimony presented.

Attorneys for Dr. Marks did not respond to a request for comment. In a statement, Ms. Baldwin said that the judge’s decision was correct.

“The district court got it exactly right, and we look forward to Ms. Plunkard receiving the compensation awarded by the jury in this tragic case,” she said.
 

Why did the patient sue?

Ms. Plunkard’s lawsuit against Dr. Marks stemmed from a January 2016 visit for complaints of bloating, pelvic pain, irregular periods, and an abnormal pelvic ultrasound. The ultrasound, ordered by her primary care physician, showed a thickened endometrial lining; a normal left ovary; and an enlarged, abnormal right ovary containing a complicated cyst, according to Ms. Plunkard’s complaint. Dr. Marks performed an endometrial biopsy and advised Ms. Plunkard that she would not need to take further measures if the result was benign, according to her lawsuit.

The result was benign, so Ms. Plunkard said she sought no further treatment for the cyst and none of her treating physicians followed up on the cyst. In February 2017, Ms. Plunkard presented to an emergency department with severe right upper quadrant abdominal pain and an ultrasound showed possible gallstones and pleural effusion, according to court documents.

After laparoscopic cholecystectomy, it was discovered that Ms. Plunkard had an inflamed pelvis and an omental lymph node was removed and biopsied. Surgeons reported that the lymph node showed metastatic cancer of probable gynecologic origin.

The patient underwent exploratory laparotomy, resulting in a radical abdominal hysterectomy, appendectomy, resection of the rectosigmoid with end-to-end anastomosis, and removal of cancerous implants. She was ultimately diagnosed with stage IVB low-grade metastatic ovarian cancer and went through six chemotherapy courses.

The patent’s cancer briefly went into remission but returned. In her complaint, Ms. Plunkard said Dr. Marks’ negligence allowed the cancer to spread from stage I to stage IVB, increasing her risk for harm and untimely death.

Dr. Marks argued that a follow-up ultrasound was not required, that the cyst on the patient’s right ovary was benign and resolved itself, that Ms. Plunkard’s cancer originated on the left, and that a follow-up ultrasound would not have detected primary cancer on the left ovary, according to legal documents.

On January 7, 2022, Dr. Marks appealed the jury’s verdict and the order denying his request for a retrial to the U.S. Court of Appeals for the Third Circuit.

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

As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

Transverse ridges that grow out with the nails are called Beau lines, also known as Beau’s ridges. This contrasts with Mees lines which are transverse white bands that grow out with the toenails, are nonpalpable, and are attributed to arsenic poisoning.

Beau lines are caused by a disruption in nail growth that can result from trauma, hypotension, or systemic or severe illness; they have also been reported in cases of COVID-19.¹ Beau lines can occur on a single nail if the trauma or injury is isolated to 1 digit. If there was a systemic illness or stress, the lines can affect all 20 nails. The time of the inciting event can be approximated by how far the lines are from the cuticle. While there is some variability, it usually takes 12 to 18 months to grow an entirely new toenail. If the Beau lines have grown halfway out, then the stressor likely occurred 6 to 9 months earlier.

In this image, some asymmetry is visible between the right and left great toenails and there are some subtle distal changes, raising the possibility that there was more than 1 injury to this patient’s system (or prolonged difficulty). The patient said that to his knowledge, he had not been infected with COVID-19. However, hair and nail changes may be the only finding in some individuals who have been infected with COVID-19.¹

This patient was counseled regarding the nature of this disorder and that without knowing what illness or injury caused the change, it was a benign finding. He was advised that it did not appear to be onychomycosis and did not require any medications or antifungal therapy. The patient was told to follow up if any changes developed.

‌

Image courtesy of Daniel Stulberg, MD. Text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Transverse ridges that grow out with the nails are called Beau lines, also known as Beau’s ridges. This contrasts with Mees lines which are transverse white bands that grow out with the toenails, are nonpalpable, and are attributed to arsenic poisoning.

Beau lines are caused by a disruption in nail growth that can result from trauma, hypotension, or systemic or severe illness; they have also been reported in cases of COVID-19.¹ Beau lines can occur on a single nail if the trauma or injury is isolated to 1 digit. If there was a systemic illness or stress, the lines can affect all 20 nails. The time of the inciting event can be approximated by how far the lines are from the cuticle. While there is some variability, it usually takes 12 to 18 months to grow an entirely new toenail. If the Beau lines have grown halfway out, then the stressor likely occurred 6 to 9 months earlier.

In this image, some asymmetry is visible between the right and left great toenails and there are some subtle distal changes, raising the possibility that there was more than 1 injury to this patient’s system (or prolonged difficulty). The patient said that to his knowledge, he had not been infected with COVID-19. However, hair and nail changes may be the only finding in some individuals who have been infected with COVID-19.¹

This patient was counseled regarding the nature of this disorder and that without knowing what illness or injury caused the change, it was a benign finding. He was advised that it did not appear to be onychomycosis and did not require any medications or antifungal therapy. The patient was told to follow up if any changes developed.

‌

Image courtesy of Daniel Stulberg, MD. Text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Transverse ridges that grow out with the nails are called Beau lines, also known as Beau’s ridges. This contrasts with Mees lines which are transverse white bands that grow out with the toenails, are nonpalpable, and are attributed to arsenic poisoning.

Beau lines are caused by a disruption in nail growth that can result from trauma, hypotension, or systemic or severe illness; they have also been reported in cases of COVID-19.¹ Beau lines can occur on a single nail if the trauma or injury is isolated to 1 digit. If there was a systemic illness or stress, the lines can affect all 20 nails. The time of the inciting event can be approximated by how far the lines are from the cuticle. While there is some variability, it usually takes 12 to 18 months to grow an entirely new toenail. If the Beau lines have grown halfway out, then the stressor likely occurred 6 to 9 months earlier.

In this image, some asymmetry is visible between the right and left great toenails and there are some subtle distal changes, raising the possibility that there was more than 1 injury to this patient’s system (or prolonged difficulty). The patient said that to his knowledge, he had not been infected with COVID-19. However, hair and nail changes may be the only finding in some individuals who have been infected with COVID-19.¹

This patient was counseled regarding the nature of this disorder and that without knowing what illness or injury caused the change, it was a benign finding. He was advised that it did not appear to be onychomycosis and did not require any medications or antifungal therapy. The patient was told to follow up if any changes developed.

‌

Image courtesy of Daniel Stulberg, MD. Text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

To the Editor:

A 72-year-old man presented with symptomatic anemia and nonpalpable purpura of the legs, abdomen, and arms of 2 weeks’ duration (Figure 1). There were no associated perifollicular papules. Physical examination of the hair and gingiva were normal.

The patient’s medical history was notable for a poorly differentiated pancreatic adenocarcinoma (pT3N1M0) resected 7 months prior using a Whipple operation (pancreaticoduodenectomy). Adjuvant therapy consisted of 5 cycles of intravenous gemcitabine and paclitaxel. Treatment was discontinued 1 month prior due to progressive weight loss and the presence of new liver metastases on computed tomography. There was no recent history of corticosteroid, antiplatelet, or anticoagulant use. The patient had no known history of trauma at the affected sites.

The patient’s laboratory workup revealed the following results: hemoglobin, 5.5 g/dL (reference range, 13–18 g/dL); platelets, 128×10⁹/L (reference range, 150–400×10⁹/L); total white blood cell count (24.0×10⁹/L [reference range, 4.0–11.0×10⁹/L]), consisting of neutrophils (2.4×10⁹/L [reference range, 2.0–7.5×10⁹/L]), lymphocytes (3.1×10⁹/L [reference range, 1.5–4.0×10⁹/L]), and monocytes (18.5×10⁹/L [reference range, 0.2–0.8×10⁹/L]). Fibrinogen, activated partial thromboplastin time, and prothrombin time were within reference range. Results of a bone marrow biopsy showed 64% blasts. The lactate dehydrogenase level was 286 U/L (reference range, 135–220 U/L) and CA-19-9 antigen was 238 U/mL (reference range, 0–39 U/mL).

Results from a skin punch biopsy from the right leg showed a normal epidermis and papillary dermis. The reticular dermis was expanded by a diffuse cellular infiltrate with dermal edema and separation of collagen bundles (Figure 2), which consisted of small cells with irregular, cleaved, and notched nuclei, containing a variable amount of eosinophilic cytoplasm. Mitotic figures were present (Figure 3). There was no evidence of vasculitis, and Congo red stain for amyloid was negative. These atypical cells were positive for the leukocyte common antigen, favoring a hematopoietic infiltrate (Figure 4). Other positive markers included CD4 (associated with helper T cells, and mature and immature monocytes), CD68 (a monocyte/macrophage marker), and CD56 (associated with natural killer cells, myeloma, acute myeloid leukemia [AML], and neuroendocrine tumors). The cells were negative for CD3 (T-cell lineage–specific antigen), CD5 (marker of T cells and a subset of IgM-secreting B cells), CD34 (early hematopoietic marker), and CD20 (B-cell marker). Other negative myeloid markers included myeloperoxidase, CD117, and CD138. These findings suggested leukemic cell recruitment at the site of a reactive infiltrate. The patient completed 2 cycles of intravenous azacitidine with little response and subsequently opted for palliative measures.

Nonpalpable purpura has a broad differential diagnosis including primary and secondary thrombocytopenia; coagulopathies, including vitamin K deficiency, specific clotting factor deficiencies, and amyloid-related purpura; genetic or acquired collagen disorders, including vitamin C deficiency; and eruptions induced by drugs and herbal remedies.

Leukemia cutis is a relatively rare cause of purpura and is defined as cutaneous infiltration by neoplastic leucocytes.¹ It most commonly is associated with AML and complicates approximately 5% to 15%of all adult cases.² Cutaneous involvement occurs predominantly in monocytic variants; acute myelomonocytic leukemia and acute monocytic leukemia may arise in up to 50% of these cases.³ The clinical presentation may vary from papules, nodules, and plaques to rarer manifestations including purpura. A leukemic infiltrate often is associated with sites of inflammation, such as infection or ulceration,⁴ though there was no reported history of any known triggering events in our patient. Lesions usually involve the legs, followed by the arms, back, chest, scalp, and face.⁴ One-third of cases coincide with systemic symptoms, and approximately 10% precede bone marrow or peripheral blood involvement, referred to as aleukemic leukemia. The remainder of cases arise following an established diagnosis of systemic leukemia.⁵ Leukemia cutis is considered a marker of poor prognosis in AML,^4,6 requiring treatment for the underlying systemic disease. Our case also was complicated by a concurrent pancreatic malignancy and relatively advanced age, which limited the feasibility of further treatment.

To the Editor:

A 72-year-old man presented with symptomatic anemia and nonpalpable purpura of the legs, abdomen, and arms of 2 weeks’ duration (Figure 1). There were no associated perifollicular papules. Physical examination of the hair and gingiva were normal.

The patient’s medical history was notable for a poorly differentiated pancreatic adenocarcinoma (pT3N1M0) resected 7 months prior using a Whipple operation (pancreaticoduodenectomy). Adjuvant therapy consisted of 5 cycles of intravenous gemcitabine and paclitaxel. Treatment was discontinued 1 month prior due to progressive weight loss and the presence of new liver metastases on computed tomography. There was no recent history of corticosteroid, antiplatelet, or anticoagulant use. The patient had no known history of trauma at the affected sites.

The patient’s laboratory workup revealed the following results: hemoglobin, 5.5 g/dL (reference range, 13–18 g/dL); platelets, 128×10⁹/L (reference range, 150–400×10⁹/L); total white blood cell count (24.0×10⁹/L [reference range, 4.0–11.0×10⁹/L]), consisting of neutrophils (2.4×10⁹/L [reference range, 2.0–7.5×10⁹/L]), lymphocytes (3.1×10⁹/L [reference range, 1.5–4.0×10⁹/L]), and monocytes (18.5×10⁹/L [reference range, 0.2–0.8×10⁹/L]). Fibrinogen, activated partial thromboplastin time, and prothrombin time were within reference range. Results of a bone marrow biopsy showed 64% blasts. The lactate dehydrogenase level was 286 U/L (reference range, 135–220 U/L) and CA-19-9 antigen was 238 U/mL (reference range, 0–39 U/mL).

Results from a skin punch biopsy from the right leg showed a normal epidermis and papillary dermis. The reticular dermis was expanded by a diffuse cellular infiltrate with dermal edema and separation of collagen bundles (Figure 2), which consisted of small cells with irregular, cleaved, and notched nuclei, containing a variable amount of eosinophilic cytoplasm. Mitotic figures were present (Figure 3). There was no evidence of vasculitis, and Congo red stain for amyloid was negative. These atypical cells were positive for the leukocyte common antigen, favoring a hematopoietic infiltrate (Figure 4). Other positive markers included CD4 (associated with helper T cells, and mature and immature monocytes), CD68 (a monocyte/macrophage marker), and CD56 (associated with natural killer cells, myeloma, acute myeloid leukemia [AML], and neuroendocrine tumors). The cells were negative for CD3 (T-cell lineage–specific antigen), CD5 (marker of T cells and a subset of IgM-secreting B cells), CD34 (early hematopoietic marker), and CD20 (B-cell marker). Other negative myeloid markers included myeloperoxidase, CD117, and CD138. These findings suggested leukemic cell recruitment at the site of a reactive infiltrate. The patient completed 2 cycles of intravenous azacitidine with little response and subsequently opted for palliative measures.

Nonpalpable purpura has a broad differential diagnosis including primary and secondary thrombocytopenia; coagulopathies, including vitamin K deficiency, specific clotting factor deficiencies, and amyloid-related purpura; genetic or acquired collagen disorders, including vitamin C deficiency; and eruptions induced by drugs and herbal remedies.

Leukemia cutis is a relatively rare cause of purpura and is defined as cutaneous infiltration by neoplastic leucocytes.¹ It most commonly is associated with AML and complicates approximately 5% to 15%of all adult cases.² Cutaneous involvement occurs predominantly in monocytic variants; acute myelomonocytic leukemia and acute monocytic leukemia may arise in up to 50% of these cases.³ The clinical presentation may vary from papules, nodules, and plaques to rarer manifestations including purpura. A leukemic infiltrate often is associated with sites of inflammation, such as infection or ulceration,⁴ though there was no reported history of any known triggering events in our patient. Lesions usually involve the legs, followed by the arms, back, chest, scalp, and face.⁴ One-third of cases coincide with systemic symptoms, and approximately 10% precede bone marrow or peripheral blood involvement, referred to as aleukemic leukemia. The remainder of cases arise following an established diagnosis of systemic leukemia.⁵ Leukemia cutis is considered a marker of poor prognosis in AML,^4,6 requiring treatment for the underlying systemic disease. Our case also was complicated by a concurrent pancreatic malignancy and relatively advanced age, which limited the feasibility of further treatment.

To the Editor:

A 72-year-old man presented with symptomatic anemia and nonpalpable purpura of the legs, abdomen, and arms of 2 weeks’ duration (Figure 1). There were no associated perifollicular papules. Physical examination of the hair and gingiva were normal.

The patient’s medical history was notable for a poorly differentiated pancreatic adenocarcinoma (pT3N1M0) resected 7 months prior using a Whipple operation (pancreaticoduodenectomy). Adjuvant therapy consisted of 5 cycles of intravenous gemcitabine and paclitaxel. Treatment was discontinued 1 month prior due to progressive weight loss and the presence of new liver metastases on computed tomography. There was no recent history of corticosteroid, antiplatelet, or anticoagulant use. The patient had no known history of trauma at the affected sites.

The patient’s laboratory workup revealed the following results: hemoglobin, 5.5 g/dL (reference range, 13–18 g/dL); platelets, 128×10⁹/L (reference range, 150–400×10⁹/L); total white blood cell count (24.0×10⁹/L [reference range, 4.0–11.0×10⁹/L]), consisting of neutrophils (2.4×10⁹/L [reference range, 2.0–7.5×10⁹/L]), lymphocytes (3.1×10⁹/L [reference range, 1.5–4.0×10⁹/L]), and monocytes (18.5×10⁹/L [reference range, 0.2–0.8×10⁹/L]). Fibrinogen, activated partial thromboplastin time, and prothrombin time were within reference range. Results of a bone marrow biopsy showed 64% blasts. The lactate dehydrogenase level was 286 U/L (reference range, 135–220 U/L) and CA-19-9 antigen was 238 U/mL (reference range, 0–39 U/mL).

Results from a skin punch biopsy from the right leg showed a normal epidermis and papillary dermis. The reticular dermis was expanded by a diffuse cellular infiltrate with dermal edema and separation of collagen bundles (Figure 2), which consisted of small cells with irregular, cleaved, and notched nuclei, containing a variable amount of eosinophilic cytoplasm. Mitotic figures were present (Figure 3). There was no evidence of vasculitis, and Congo red stain for amyloid was negative. These atypical cells were positive for the leukocyte common antigen, favoring a hematopoietic infiltrate (Figure 4). Other positive markers included CD4 (associated with helper T cells, and mature and immature monocytes), CD68 (a monocyte/macrophage marker), and CD56 (associated with natural killer cells, myeloma, acute myeloid leukemia [AML], and neuroendocrine tumors). The cells were negative for CD3 (T-cell lineage–specific antigen), CD5 (marker of T cells and a subset of IgM-secreting B cells), CD34 (early hematopoietic marker), and CD20 (B-cell marker). Other negative myeloid markers included myeloperoxidase, CD117, and CD138. These findings suggested leukemic cell recruitment at the site of a reactive infiltrate. The patient completed 2 cycles of intravenous azacitidine with little response and subsequently opted for palliative measures.

Nonpalpable purpura has a broad differential diagnosis including primary and secondary thrombocytopenia; coagulopathies, including vitamin K deficiency, specific clotting factor deficiencies, and amyloid-related purpura; genetic or acquired collagen disorders, including vitamin C deficiency; and eruptions induced by drugs and herbal remedies.

Leukemia cutis is a relatively rare cause of purpura and is defined as cutaneous infiltration by neoplastic leucocytes.¹ It most commonly is associated with AML and complicates approximately 5% to 15%of all adult cases.² Cutaneous involvement occurs predominantly in monocytic variants; acute myelomonocytic leukemia and acute monocytic leukemia may arise in up to 50% of these cases.³ The clinical presentation may vary from papules, nodules, and plaques to rarer manifestations including purpura. A leukemic infiltrate often is associated with sites of inflammation, such as infection or ulceration,⁴ though there was no reported history of any known triggering events in our patient. Lesions usually involve the legs, followed by the arms, back, chest, scalp, and face.⁴ One-third of cases coincide with systemic symptoms, and approximately 10% precede bone marrow or peripheral blood involvement, referred to as aleukemic leukemia. The remainder of cases arise following an established diagnosis of systemic leukemia.⁵ Leukemia cutis is considered a marker of poor prognosis in AML,^4,6 requiring treatment for the underlying systemic disease. Our case also was complicated by a concurrent pancreatic malignancy and relatively advanced age, which limited the feasibility of further treatment.

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

Columbia University has suspended Jeffrey Lieberman, MD, as chair of the psychiatry department at the Vagelos College of Physicians and Surgeons and has removed him as psychiatrist-in-chief at New York Presbyterian Hospital.

The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.

The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.

Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.

However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”

The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.

Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
 

Apology letter?

David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.

In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”

“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.

Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”

This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.  

Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.

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

Columbia University has suspended Jeffrey Lieberman, MD, as chair of the psychiatry department at the Vagelos College of Physicians and Surgeons and has removed him as psychiatrist-in-chief at New York Presbyterian Hospital.

The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.

The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.

Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.

However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”

The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.

Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
 

Apology letter?

David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.

In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”

“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.

Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”

This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.  

Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.

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

Columbia University has suspended Jeffrey Lieberman, MD, as chair of the psychiatry department at the Vagelos College of Physicians and Surgeons and has removed him as psychiatrist-in-chief at New York Presbyterian Hospital.

The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.

The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.

Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.

However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”

The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.

Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
 

Apology letter?

David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.

In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”

“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.

Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”

This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.  

Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.

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

Hemodynamic instability is rewarded with a sojourn in the intensive care unit (ICU). When the intensivists see it, they’re going to throw fluids at it. Most likely a crystalloid of some type. This has been true for decades, centuries even. When I was a medical student, which was decades but not centuries ago, I used crystalloids every day on the surgical wards, in the operating room, in the emergency department, or on the medicine wards. Medicine docs preferred normal saline (NS) and surgeons used lactated Ringer’s solution (LR). I never gave this a second thought.

During medical school, I was drawn to internal medicine by the heavy emphasis on evidence-based medicine in the field. Prior to 2015 though, there wasn’t much data to support using one crystalloid formulation over another. Pre-2010, we had an American Thoracic Society (ATS) consensus statement on using crystalloid vs. colloid, making recommendations largely drawn from the SAFE trial. The ATS statement also suggested starches may be harmful, a view that was confirmed in a series of articles published in 2012 and 2013. There was less discussion about what type of crystalloid was best.

In 2014, I finally read a paper that compared crystalloid formulations. It was a network meta-analysis, which is “statistician speak” for combining disparate trials to make indirect comparisons. In the absence of large, randomized trials, this approach was a welcome addition to the data we had at the time. The authors concluded that “balanced” (typically LR or Plasma-Lyte) are superior to “unbalanced” (another term for NS) crystalloids. Balanced fluids typically have acetate or lactate and have a higher pH and lower chloride than NS. I found the signal for balanced fluids interesting at the time but promptly forgot about it.

Since 2015, the critical care community has rallied to produce a bevy of large trials comparing balanced vs. unbalanced crystalloids. The first was the SPLIT trial, which showed equivalence. Then came the SMART trial in 2018, which showed balanced fluids were better. Of note, another trial with an identical design (SALT-ED) was published in the same issue of The New England Journal of Medicine as SMART. SALT-ED enrolled patients in the emergency department, not the ICU, but also found benefit to using balanced fluids, albeit not for their primary outcome. I admit, after SMART and SALT-ED were published, I made the switch to LR. A secondary analysis of patients with sepsis pushed me further toward LR, while others withheld judgment.

Then we saw publication of the BaSICs trial, another large, randomized study evaluating crystalloid composition. I was hoping this one might put the issue to rest. That nephrologist who perseverated on every patient’s chloride during morning report would be vindicated. NS would prove to be too unbalanced and would finally be retired. No such luck. This is critical care medicine, where the initial signal is rarely confirmed in the follow-up trials. BaSICs found no difference between crystalloids for most important outcomes. The study did find balanced fluids may worsen outcomes for patients with head injuries.

Finally, there’s the PLUS trial, a large, multicenter randomized controlled trial comparing Plasma-Lyte vs. NS in the ICU. I could make the argument that this trial was the best of the bunch, and it was negative. The researchers did an excellent job of showing that serum pH and chloride levels did vary by fluid composition, but despite this, mortality and renal outcomes did not differ. Case closed? Crystalloid composition doesn’t matter, right?

An editorial that accompanies the BaSICs trial does an outstanding job of reviewing SPLIT, SMART, and BaSICs. The authors discuss design and population differences that may have led to differing results, and there are many. They conclude for most patients in the ICU, there’s no compelling reason to choose one crystalloid over another. Perhaps they’re right.

An updated meta-analysis that included all the studies I’ve mentioned concluded there was an 89% probability that balanced fluid reduces mortality for ICU patients. How could the meta-analysis authors reach this conclusion given all the negative trials? It has to do with their statistical methods – they performed both standard, frequentist (if statistical significance isn’t reached the study, is considered negative) and Bayesian analyses (posterior probability of benefit is calculated, regardless of P value). The frequentist approach was negative, but the posterior probability for benefit remained high.

Personally, I see no reason not to favor LR when resuscitating ICU patients without head injuries. In particular, it seems that medical patients (who made up almost 80% of those in the SMART trial) and those with sepsis may benefit. The critical care community has again outdone itself by performing large, well-designed trials to address important questions. Despite not having a definitive answer on crystalloid resuscitation, we know a lot more than we did when I was a medical student.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He reported receiving research grant from: Fisher-Paykel and receiving income from the American College of Chest Physicians. A version of this article first appeared on Medscape.com.

Hemodynamic instability is rewarded with a sojourn in the intensive care unit (ICU). When the intensivists see it, they’re going to throw fluids at it. Most likely a crystalloid of some type. This has been true for decades, centuries even. When I was a medical student, which was decades but not centuries ago, I used crystalloids every day on the surgical wards, in the operating room, in the emergency department, or on the medicine wards. Medicine docs preferred normal saline (NS) and surgeons used lactated Ringer’s solution (LR). I never gave this a second thought.

During medical school, I was drawn to internal medicine by the heavy emphasis on evidence-based medicine in the field. Prior to 2015 though, there wasn’t much data to support using one crystalloid formulation over another. Pre-2010, we had an American Thoracic Society (ATS) consensus statement on using crystalloid vs. colloid, making recommendations largely drawn from the SAFE trial. The ATS statement also suggested starches may be harmful, a view that was confirmed in a series of articles published in 2012 and 2013. There was less discussion about what type of crystalloid was best.

In 2014, I finally read a paper that compared crystalloid formulations. It was a network meta-analysis, which is “statistician speak” for combining disparate trials to make indirect comparisons. In the absence of large, randomized trials, this approach was a welcome addition to the data we had at the time. The authors concluded that “balanced” (typically LR or Plasma-Lyte) are superior to “unbalanced” (another term for NS) crystalloids. Balanced fluids typically have acetate or lactate and have a higher pH and lower chloride than NS. I found the signal for balanced fluids interesting at the time but promptly forgot about it.

Since 2015, the critical care community has rallied to produce a bevy of large trials comparing balanced vs. unbalanced crystalloids. The first was the SPLIT trial, which showed equivalence. Then came the SMART trial in 2018, which showed balanced fluids were better. Of note, another trial with an identical design (SALT-ED) was published in the same issue of The New England Journal of Medicine as SMART. SALT-ED enrolled patients in the emergency department, not the ICU, but also found benefit to using balanced fluids, albeit not for their primary outcome. I admit, after SMART and SALT-ED were published, I made the switch to LR. A secondary analysis of patients with sepsis pushed me further toward LR, while others withheld judgment.

Then we saw publication of the BaSICs trial, another large, randomized study evaluating crystalloid composition. I was hoping this one might put the issue to rest. That nephrologist who perseverated on every patient’s chloride during morning report would be vindicated. NS would prove to be too unbalanced and would finally be retired. No such luck. This is critical care medicine, where the initial signal is rarely confirmed in the follow-up trials. BaSICs found no difference between crystalloids for most important outcomes. The study did find balanced fluids may worsen outcomes for patients with head injuries.

Finally, there’s the PLUS trial, a large, multicenter randomized controlled trial comparing Plasma-Lyte vs. NS in the ICU. I could make the argument that this trial was the best of the bunch, and it was negative. The researchers did an excellent job of showing that serum pH and chloride levels did vary by fluid composition, but despite this, mortality and renal outcomes did not differ. Case closed? Crystalloid composition doesn’t matter, right?

An editorial that accompanies the BaSICs trial does an outstanding job of reviewing SPLIT, SMART, and BaSICs. The authors discuss design and population differences that may have led to differing results, and there are many. They conclude for most patients in the ICU, there’s no compelling reason to choose one crystalloid over another. Perhaps they’re right.

An updated meta-analysis that included all the studies I’ve mentioned concluded there was an 89% probability that balanced fluid reduces mortality for ICU patients. How could the meta-analysis authors reach this conclusion given all the negative trials? It has to do with their statistical methods – they performed both standard, frequentist (if statistical significance isn’t reached the study, is considered negative) and Bayesian analyses (posterior probability of benefit is calculated, regardless of P value). The frequentist approach was negative, but the posterior probability for benefit remained high.

Personally, I see no reason not to favor LR when resuscitating ICU patients without head injuries. In particular, it seems that medical patients (who made up almost 80% of those in the SMART trial) and those with sepsis may benefit. The critical care community has again outdone itself by performing large, well-designed trials to address important questions. Despite not having a definitive answer on crystalloid resuscitation, we know a lot more than we did when I was a medical student.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He reported receiving research grant from: Fisher-Paykel and receiving income from the American College of Chest Physicians. A version of this article first appeared on Medscape.com.

Hemodynamic instability is rewarded with a sojourn in the intensive care unit (ICU). When the intensivists see it, they’re going to throw fluids at it. Most likely a crystalloid of some type. This has been true for decades, centuries even. When I was a medical student, which was decades but not centuries ago, I used crystalloids every day on the surgical wards, in the operating room, in the emergency department, or on the medicine wards. Medicine docs preferred normal saline (NS) and surgeons used lactated Ringer’s solution (LR). I never gave this a second thought.

During medical school, I was drawn to internal medicine by the heavy emphasis on evidence-based medicine in the field. Prior to 2015 though, there wasn’t much data to support using one crystalloid formulation over another. Pre-2010, we had an American Thoracic Society (ATS) consensus statement on using crystalloid vs. colloid, making recommendations largely drawn from the SAFE trial. The ATS statement also suggested starches may be harmful, a view that was confirmed in a series of articles published in 2012 and 2013. There was less discussion about what type of crystalloid was best.

In 2014, I finally read a paper that compared crystalloid formulations. It was a network meta-analysis, which is “statistician speak” for combining disparate trials to make indirect comparisons. In the absence of large, randomized trials, this approach was a welcome addition to the data we had at the time. The authors concluded that “balanced” (typically LR or Plasma-Lyte) are superior to “unbalanced” (another term for NS) crystalloids. Balanced fluids typically have acetate or lactate and have a higher pH and lower chloride than NS. I found the signal for balanced fluids interesting at the time but promptly forgot about it.

Since 2015, the critical care community has rallied to produce a bevy of large trials comparing balanced vs. unbalanced crystalloids. The first was the SPLIT trial, which showed equivalence. Then came the SMART trial in 2018, which showed balanced fluids were better. Of note, another trial with an identical design (SALT-ED) was published in the same issue of The New England Journal of Medicine as SMART. SALT-ED enrolled patients in the emergency department, not the ICU, but also found benefit to using balanced fluids, albeit not for their primary outcome. I admit, after SMART and SALT-ED were published, I made the switch to LR. A secondary analysis of patients with sepsis pushed me further toward LR, while others withheld judgment.

Then we saw publication of the BaSICs trial, another large, randomized study evaluating crystalloid composition. I was hoping this one might put the issue to rest. That nephrologist who perseverated on every patient’s chloride during morning report would be vindicated. NS would prove to be too unbalanced and would finally be retired. No such luck. This is critical care medicine, where the initial signal is rarely confirmed in the follow-up trials. BaSICs found no difference between crystalloids for most important outcomes. The study did find balanced fluids may worsen outcomes for patients with head injuries.

Finally, there’s the PLUS trial, a large, multicenter randomized controlled trial comparing Plasma-Lyte vs. NS in the ICU. I could make the argument that this trial was the best of the bunch, and it was negative. The researchers did an excellent job of showing that serum pH and chloride levels did vary by fluid composition, but despite this, mortality and renal outcomes did not differ. Case closed? Crystalloid composition doesn’t matter, right?

An editorial that accompanies the BaSICs trial does an outstanding job of reviewing SPLIT, SMART, and BaSICs. The authors discuss design and population differences that may have led to differing results, and there are many. They conclude for most patients in the ICU, there’s no compelling reason to choose one crystalloid over another. Perhaps they’re right.

An updated meta-analysis that included all the studies I’ve mentioned concluded there was an 89% probability that balanced fluid reduces mortality for ICU patients. How could the meta-analysis authors reach this conclusion given all the negative trials? It has to do with their statistical methods – they performed both standard, frequentist (if statistical significance isn’t reached the study, is considered negative) and Bayesian analyses (posterior probability of benefit is calculated, regardless of P value). The frequentist approach was negative, but the posterior probability for benefit remained high.

Personally, I see no reason not to favor LR when resuscitating ICU patients without head injuries. In particular, it seems that medical patients (who made up almost 80% of those in the SMART trial) and those with sepsis may benefit. The critical care community has again outdone itself by performing large, well-designed trials to address important questions. Despite not having a definitive answer on crystalloid resuscitation, we know a lot more than we did when I was a medical student.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He reported receiving research grant from: Fisher-Paykel and receiving income from the American College of Chest Physicians. A version of this article first appeared on Medscape.com.

About 80% of people infected with Zika virus show no symptoms, and that’s particularly problematic during pregnancy. The infection can cause birth defects and is the origin of numerous cases of microcephaly and other neurologic impairments.

The large amount of Aedes aegypti mosquitoes in Brazilian cities, in addition to social and political problems, facilitated the spread of Zika to the point that the country recorded its highest number of congenital Zika syndrome notifications from 2015 to 2018. Since then, researchers have investigated the extent of the problem.

One of the most compelling findings about the dramatic legacy of Zika in Brazil was published Feb. 24 in The New England Journal of Medicine: After tracking 11,481,215 children born alive in Brazil up to 36 months of age between the years 2015 and 2018, the researchers found that the mortality rate was about 12 times higher among children with congenital Zika syndrome in comparison to children without the syndrome. The study is the first to follow children with congenital Zika syndrome for 3 years and to report mortality in this group.

“This difference persisted throughout the first 3 years of life,” Enny S. Paixão, PhD, of the London School of Hygiene and Tropical Medicine, and Fiocruz-Bahia’s Instituto Gonçalo Moniz, in Brazil, said in an interview.

At the end of the study period, the mortality rate was 52.6 deaths (95% confidence interval, 47.6-58.0) per 1,000 person-years among children with congenital Zika syndrome and 5.6 deaths (95% CI, 5.6-5.7) per 1,000 person-years among those without the syndrome. The mortality rate ratio among children with congenital Zika syndrome, compared with those without it, was 11.3 (95% CI, 10.2-12.4). Data analysis also showed that the 3,308 children with the syndrome were born to mothers who were younger and had fewer years of study when compared to the mothers of their 11,477,907 counterparts without the syndrome.

“If the children survived the first month of life, they had a greater chance of surviving during childhood, because the mortality rates drop,” said Dr. Paixão. “In children with congenital Zika syndrome, this rate also drops, but slowly. The more we stratified by period – neonatal, post neonatal, and the period from the first to the third year of life – the more we saw the relative risk increase. After the first year of life, children with the syndrome were almost 22 times more likely to die compared to children without it. It was hard to believe the data.” Dr. Paixão added that the mortality observed in this study is comparable with the findings of previous studies.

In addition to the large sample size – more than 11 million children – another unique aspect of the work was the comparison with healthy live births. “Previous studies didn’t have this comparison group,” Dr. said Paixão.

Perhaps the major challenge of the study, Dr. Paixão explained, was the fragmentation of the data. “In Brazil we have high-quality data systems, but they are not interconnected. We have a database with all live births, another with mortality records, and another with all children with congenital Zika syndrome. The first big challenge was putting all this information together.”

The solution found by the researchers was to use data linkage – bringing information about the same person from different data banks to create a richer dataset. Basically, they linked the data from the live births registry with the deaths that occurred in the studied age group plus around 18,000 children with congenital Zika syndrome. This was done, said Dr. Paixão, by choosing some identifying variables (such as mother’s name, address, and age) and using an algorithm that evaluates the probability that the “N” in one database is the same person in another database.

“This is expensive, complex, [and] involves super-powerful computers and a lot of researchers,” she said.

The impressive mortality data for children with congenital Zika syndrome obtained by the group of researchers made it inevitable to think about how the country should address this terrible legacy.

“The first and most important recommendation is that the country needs to invest in primary care, so that women don’t get Zika during pregnancy and children aren’t at risk of getting the syndrome,” said Dr. Paixão.

As for the affected population, she highlighted the need to deepen the understanding of the syndrome’s natural history to improve survival and quality of life of affected children and their families. One possibility that was recently discussed by the group of researchers is to carry out a study on the causes of hospitalization of children with the syndrome to develop appropriate protocols and procedures that reduce admissions and death in this population.

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

About 80% of people infected with Zika virus show no symptoms, and that’s particularly problematic during pregnancy. The infection can cause birth defects and is the origin of numerous cases of microcephaly and other neurologic impairments.

The large amount of Aedes aegypti mosquitoes in Brazilian cities, in addition to social and political problems, facilitated the spread of Zika to the point that the country recorded its highest number of congenital Zika syndrome notifications from 2015 to 2018. Since then, researchers have investigated the extent of the problem.

One of the most compelling findings about the dramatic legacy of Zika in Brazil was published Feb. 24 in The New England Journal of Medicine: After tracking 11,481,215 children born alive in Brazil up to 36 months of age between the years 2015 and 2018, the researchers found that the mortality rate was about 12 times higher among children with congenital Zika syndrome in comparison to children without the syndrome. The study is the first to follow children with congenital Zika syndrome for 3 years and to report mortality in this group.

“This difference persisted throughout the first 3 years of life,” Enny S. Paixão, PhD, of the London School of Hygiene and Tropical Medicine, and Fiocruz-Bahia’s Instituto Gonçalo Moniz, in Brazil, said in an interview.

At the end of the study period, the mortality rate was 52.6 deaths (95% confidence interval, 47.6-58.0) per 1,000 person-years among children with congenital Zika syndrome and 5.6 deaths (95% CI, 5.6-5.7) per 1,000 person-years among those without the syndrome. The mortality rate ratio among children with congenital Zika syndrome, compared with those without it, was 11.3 (95% CI, 10.2-12.4). Data analysis also showed that the 3,308 children with the syndrome were born to mothers who were younger and had fewer years of study when compared to the mothers of their 11,477,907 counterparts without the syndrome.

“If the children survived the first month of life, they had a greater chance of surviving during childhood, because the mortality rates drop,” said Dr. Paixão. “In children with congenital Zika syndrome, this rate also drops, but slowly. The more we stratified by period – neonatal, post neonatal, and the period from the first to the third year of life – the more we saw the relative risk increase. After the first year of life, children with the syndrome were almost 22 times more likely to die compared to children without it. It was hard to believe the data.” Dr. Paixão added that the mortality observed in this study is comparable with the findings of previous studies.

In addition to the large sample size – more than 11 million children – another unique aspect of the work was the comparison with healthy live births. “Previous studies didn’t have this comparison group,” Dr. said Paixão.

Perhaps the major challenge of the study, Dr. Paixão explained, was the fragmentation of the data. “In Brazil we have high-quality data systems, but they are not interconnected. We have a database with all live births, another with mortality records, and another with all children with congenital Zika syndrome. The first big challenge was putting all this information together.”

The solution found by the researchers was to use data linkage – bringing information about the same person from different data banks to create a richer dataset. Basically, they linked the data from the live births registry with the deaths that occurred in the studied age group plus around 18,000 children with congenital Zika syndrome. This was done, said Dr. Paixão, by choosing some identifying variables (such as mother’s name, address, and age) and using an algorithm that evaluates the probability that the “N” in one database is the same person in another database.

“This is expensive, complex, [and] involves super-powerful computers and a lot of researchers,” she said.

The impressive mortality data for children with congenital Zika syndrome obtained by the group of researchers made it inevitable to think about how the country should address this terrible legacy.

“The first and most important recommendation is that the country needs to invest in primary care, so that women don’t get Zika during pregnancy and children aren’t at risk of getting the syndrome,” said Dr. Paixão.

As for the affected population, she highlighted the need to deepen the understanding of the syndrome’s natural history to improve survival and quality of life of affected children and their families. One possibility that was recently discussed by the group of researchers is to carry out a study on the causes of hospitalization of children with the syndrome to develop appropriate protocols and procedures that reduce admissions and death in this population.

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

About 80% of people infected with Zika virus show no symptoms, and that’s particularly problematic during pregnancy. The infection can cause birth defects and is the origin of numerous cases of microcephaly and other neurologic impairments.

The large amount of Aedes aegypti mosquitoes in Brazilian cities, in addition to social and political problems, facilitated the spread of Zika to the point that the country recorded its highest number of congenital Zika syndrome notifications from 2015 to 2018. Since then, researchers have investigated the extent of the problem.

One of the most compelling findings about the dramatic legacy of Zika in Brazil was published Feb. 24 in The New England Journal of Medicine: After tracking 11,481,215 children born alive in Brazil up to 36 months of age between the years 2015 and 2018, the researchers found that the mortality rate was about 12 times higher among children with congenital Zika syndrome in comparison to children without the syndrome. The study is the first to follow children with congenital Zika syndrome for 3 years and to report mortality in this group.

“This difference persisted throughout the first 3 years of life,” Enny S. Paixão, PhD, of the London School of Hygiene and Tropical Medicine, and Fiocruz-Bahia’s Instituto Gonçalo Moniz, in Brazil, said in an interview.

At the end of the study period, the mortality rate was 52.6 deaths (95% confidence interval, 47.6-58.0) per 1,000 person-years among children with congenital Zika syndrome and 5.6 deaths (95% CI, 5.6-5.7) per 1,000 person-years among those without the syndrome. The mortality rate ratio among children with congenital Zika syndrome, compared with those without it, was 11.3 (95% CI, 10.2-12.4). Data analysis also showed that the 3,308 children with the syndrome were born to mothers who were younger and had fewer years of study when compared to the mothers of their 11,477,907 counterparts without the syndrome.

“If the children survived the first month of life, they had a greater chance of surviving during childhood, because the mortality rates drop,” said Dr. Paixão. “In children with congenital Zika syndrome, this rate also drops, but slowly. The more we stratified by period – neonatal, post neonatal, and the period from the first to the third year of life – the more we saw the relative risk increase. After the first year of life, children with the syndrome were almost 22 times more likely to die compared to children without it. It was hard to believe the data.” Dr. Paixão added that the mortality observed in this study is comparable with the findings of previous studies.

In addition to the large sample size – more than 11 million children – another unique aspect of the work was the comparison with healthy live births. “Previous studies didn’t have this comparison group,” Dr. said Paixão.

Perhaps the major challenge of the study, Dr. Paixão explained, was the fragmentation of the data. “In Brazil we have high-quality data systems, but they are not interconnected. We have a database with all live births, another with mortality records, and another with all children with congenital Zika syndrome. The first big challenge was putting all this information together.”

The solution found by the researchers was to use data linkage – bringing information about the same person from different data banks to create a richer dataset. Basically, they linked the data from the live births registry with the deaths that occurred in the studied age group plus around 18,000 children with congenital Zika syndrome. This was done, said Dr. Paixão, by choosing some identifying variables (such as mother’s name, address, and age) and using an algorithm that evaluates the probability that the “N” in one database is the same person in another database.

“This is expensive, complex, [and] involves super-powerful computers and a lot of researchers,” she said.

The impressive mortality data for children with congenital Zika syndrome obtained by the group of researchers made it inevitable to think about how the country should address this terrible legacy.

“The first and most important recommendation is that the country needs to invest in primary care, so that women don’t get Zika during pregnancy and children aren’t at risk of getting the syndrome,” said Dr. Paixão.

As for the affected population, she highlighted the need to deepen the understanding of the syndrome’s natural history to improve survival and quality of life of affected children and their families. One possibility that was recently discussed by the group of researchers is to carry out a study on the causes of hospitalization of children with the syndrome to develop appropriate protocols and procedures that reduce admissions and death in this population.

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