Federal Practitioner

This transcript has been edited for clarity.

Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany. Today, I would like to discuss what happened in neurology in the past month.
 

Treatment of tension-type headache

I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.

A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.

The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.

In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
 

Headache after COVID-19

The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.

SSRIs during COVID-19 infection

The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.

Preventing dementia with antihypertensive treatment

The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.

Antiplatelet therapy

The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.

Regular exercise in Parkinson’s disease

The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.

Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany. Today, I would like to discuss what happened in neurology in the past month.
 

Treatment of tension-type headache

I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.

A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.

The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.

In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
 

Headache after COVID-19

The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.

SSRIs during COVID-19 infection

The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.

Preventing dementia with antihypertensive treatment

The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.

Antiplatelet therapy

The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.

Regular exercise in Parkinson’s disease

The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.

Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Dear colleagues, I am Christoph Diener from the medical faculty of the University of Duisburg-Essen in Germany. Today, I would like to discuss what happened in neurology in the past month.
 

Treatment of tension-type headache

I would like to start with headache. You are all aware that we have several new studies regarding the prevention of migraine, but very few studies involving nondrug treatments for tension-type headache.

A working group in Göttingen, Germany, conducted a study in people with frequent episodic and chronic tension-type headache. The first of the four randomized groups received traditional Chinese acupuncture for 3 months. The second group received physical therapy and exercise for 1 hour per week for 12 weeks. The third group received a combination of acupuncture and exercise. The last was a control group that received only standard care.

The outcome parameters of tension-type headache were evaluated after 6 months and again after 12 months. Previously, these same researchers published that the intensity but not the frequency of tension-type headache was reduced by active therapy.

In Cephalalgia, they published the outcome for the endpoints of depression, anxiety, and quality of life. Acupuncture, exercise, and the combination of the two improved depression, anxiety, and quality of life. This shows that nonmedical treatment is effective in people with frequent episodic and chronic tension-type headache.
 

Headache after COVID-19

The next study was published in Headache and discusses headache after COVID-19. In this review of published studies, more than 50% of people with COVID-19 develop headache. It is more frequent in young patients and people with preexisting primary headaches, such as migraine and tension-type headache. Prognosis is usually good, but some patients develop new, daily persistent headache, which is a major problem because treatment is unclear. We desperately need studies investigating how to treat this new, daily persistent headache after COVID-19.

SSRIs during COVID-19 infection

The next study also focuses on COVID-19. We have conflicting results from several studies suggesting that selective serotonin reuptake inhibitors might be effective in people with mild COVID-19 infection. This hypothesis was tested in a study in Brazil and was published in JAMA, The study included 1,288 outpatients with mild COVID-19 who either received 50 mg of fluvoxamine twice daily for 10 days or placebo. There was no benefit of the treatment for any outcome.

Preventing dementia with antihypertensive treatment

The next study was published in the European Heart Journal and addresses the question of whether effective antihypertensive treatment in elderly persons can prevent dementia. This is a meta-analysis of five placebo-controlled trials with more than 28,000 patients. The meta-analysis clearly shows that treating hypertension in elderly patients does prevent dementia. The benefit is higher if the blood pressure is lowered by a larger amount which also stays true for elderly patients. There is no negative impact of lowering blood pressure in this population.

Antiplatelet therapy

The next study was published in Stroke and reexamines whether resumption of antiplatelet therapy should be early or late in people who had an intracerebral hemorrhage while on antiplatelet therapy. In the Taiwanese Health Registry, this was studied in 1,584 patients. The researchers divided participants into groups based on whether antiplatelet therapy was resumed within 30 days or after 30 days. In 1 year, the rate of recurrent intracerebral hemorrhage was 3.2%. There was no difference whether antiplatelet therapy was resumed early or late.

Regular exercise in Parkinson’s disease

The final study is a review of nonmedical therapy. This meta-analysis of 19 randomized trials looked at the benefit of regular exercise in patients with Parkinson’s disease and depression. The analysis clearly showed that rigorous and moderate exercise improved depression in patients with Parkinson’s disease. This is very important because exercise improves not only the symptoms of Parkinson’s disease but also comorbid depression while presenting no serious adverse events or side effects.

Dr. Diener is a professor in the department of neurology at Stroke Center–Headache Center, University Duisburg-Essen, Germany. He disclosed ties with Abbott, Addex Pharma, Alder, Allergan, Almirall, Amgen, Autonomic Technology, AstraZeneca, Bayer Vital, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Chordate, CoAxia, Corimmun, Covidien, Coherex, CoLucid, Daiichi Sankyo, D-Pharm, Electrocore, Fresenius, GlaxoSmithKline, Grunenthal, Janssen-Cilag, Labrys Biologics Lilly, La Roche, Lundbeck, 3M Medica, MSD, Medtronic, Menarini, MindFrame, Minster, Neuroscore, Neurobiological Technologies, Novartis, Novo Nordisk, Johnson & Johnson, Knoll, Paion, Parke-Davis, Pierre Fabre, Pfizer Inc, Schaper and Brummer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Talecris, Thrombogenics, WebMD Global, Weber and Weber, Wyeth, and Yamanouchi. Dr. Diener has served as editor of Aktuelle Neurologie, Arzneimitteltherapie, Kopfschmerz News, Stroke News, and the Treatment Guidelines of the German Neurological Society; as co-editor of Cephalalgia; and on the editorial board of The Lancet Neurology, Stroke, European Neurology, and Cerebrovascular Disorders. The department of neurology in Essen is supported by the German Research Council, the German Ministry of Education and Research, European Union, National Institutes of Health, Bertelsmann Foundation, and Heinz Nixdorf Foundation. Dr. Diener has no ownership interest and does not own stocks in any pharmaceutical company. A version of this article originally appeared on Medscape.com.

A new study says we can slow the pace at which we age by 2%-3% if we lower the number of calories we eat by 25%. That may seem like a little benefit for a large cut in calories. But experts say it’s actually a pretty big deal.

“In other studies, that same difference in pace of aging had meaningful consequences for people’s risk of dying,” says senior study author Daniel W. Belsky, PhD, a researcher at the Butler Columbia Aging Center at Columbia University, New York.

Cutting calories by 25% slowed the pace of aging in young and middle-aged adults by a few percentage points, compared with those who continued eating normally, the new research reveals. This first-of-its-kind study in humans adds to evidence from animal studies that the rate of aging can be changed.

Compared with 75 people who ate normally, the 145 people randomly assigned to cut back their calories slowed their pace of aging by 2%-3% over 2 years in the randomized controlled trial.

For example, a similar slowdown in the pace of aging was associated with a 10%-15% lower risk of dying over 10-15 years in previous work, Dr. Belsky says. “So 2%-3% slower aging doesn’t sound like maybe that big of a deal – but 10%-15% reduction in risk of dying seems like a big deal.”

Results of the study were published in the journal Nature Aging.

Even though the pace of aging slowed, the researchers did not find significant changes on two biological aging measures in the study, suggesting more work is needed.

The findings “are intriguing in that caloric restriction seemed to show a slower pace of aging in healthy adults,” says Vandana Sheth, a registered dietitian-nutritionist and owner of a nutrition consulting firm in Los Angeles. “This can have a significant impact on population health. However, larger studies need to be done to follow up on these findings.”


 

‘Exciting result’

Asked if the findings imply aging could be slowed down in people, Dr. Belsky says. “That is the ... exciting result from the trial. These results suggest it may be possible to slow the pace of biological aging with a behavioral intervention.”

But not everyone is completely convinced.

“This is good suggestive evidence that caloric restriction can modify aspects of biological aging in humans, similar to what has been known in laboratory animals for many decades,” says Matt Kaeberlein, PhD, director of the Healthy Aging and Longevity Research Institute at the University of Washington, Seattle, and senior author of a 2021 review article in Science.

Part of his concern is that cutting your calories by a quarter may not be a sustainable long-term strategy.

“It’s important to keep in mind that these measurements only report on a portion of biological aging and are probably not an accurate overall measurement of biological age or the rate of biological aging,” Dr. Kaeberlein says. The findings might suggest that “at the population level, a 25% reduction in caloric intake is unlikely to have large effects on biological aging unless implemented over many years, which is likely not reasonable for most people.”

Insight into intermittent fasting?

Cutting back on calories is related to other dietary strategies, including intermittent fasting and time-restricted eating, Dr. Belsky says. “Intermittent fasting and time-restricted eating are nutritional interventions that have been developed, in part, because in experiments with animals, they have some of the same biological effects as calorie restriction.”

There remain many unanswered questions.

“There are people who would argue that the reason calorie restriction does what it does is because when people are calorie-restricted, they also tend to restrict the times when they eat,” Dr. Belsky says. “They tend to have these longer fasts during the day.”

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

A new study says we can slow the pace at which we age by 2%-3% if we lower the number of calories we eat by 25%. That may seem like a little benefit for a large cut in calories. But experts say it’s actually a pretty big deal.

“In other studies, that same difference in pace of aging had meaningful consequences for people’s risk of dying,” says senior study author Daniel W. Belsky, PhD, a researcher at the Butler Columbia Aging Center at Columbia University, New York.

Cutting calories by 25% slowed the pace of aging in young and middle-aged adults by a few percentage points, compared with those who continued eating normally, the new research reveals. This first-of-its-kind study in humans adds to evidence from animal studies that the rate of aging can be changed.

Compared with 75 people who ate normally, the 145 people randomly assigned to cut back their calories slowed their pace of aging by 2%-3% over 2 years in the randomized controlled trial.

For example, a similar slowdown in the pace of aging was associated with a 10%-15% lower risk of dying over 10-15 years in previous work, Dr. Belsky says. “So 2%-3% slower aging doesn’t sound like maybe that big of a deal – but 10%-15% reduction in risk of dying seems like a big deal.”

Results of the study were published in the journal Nature Aging.

Even though the pace of aging slowed, the researchers did not find significant changes on two biological aging measures in the study, suggesting more work is needed.

The findings “are intriguing in that caloric restriction seemed to show a slower pace of aging in healthy adults,” says Vandana Sheth, a registered dietitian-nutritionist and owner of a nutrition consulting firm in Los Angeles. “This can have a significant impact on population health. However, larger studies need to be done to follow up on these findings.”


 

‘Exciting result’

Asked if the findings imply aging could be slowed down in people, Dr. Belsky says. “That is the ... exciting result from the trial. These results suggest it may be possible to slow the pace of biological aging with a behavioral intervention.”

But not everyone is completely convinced.

“This is good suggestive evidence that caloric restriction can modify aspects of biological aging in humans, similar to what has been known in laboratory animals for many decades,” says Matt Kaeberlein, PhD, director of the Healthy Aging and Longevity Research Institute at the University of Washington, Seattle, and senior author of a 2021 review article in Science.

Part of his concern is that cutting your calories by a quarter may not be a sustainable long-term strategy.

“It’s important to keep in mind that these measurements only report on a portion of biological aging and are probably not an accurate overall measurement of biological age or the rate of biological aging,” Dr. Kaeberlein says. The findings might suggest that “at the population level, a 25% reduction in caloric intake is unlikely to have large effects on biological aging unless implemented over many years, which is likely not reasonable for most people.”

Insight into intermittent fasting?

Cutting back on calories is related to other dietary strategies, including intermittent fasting and time-restricted eating, Dr. Belsky says. “Intermittent fasting and time-restricted eating are nutritional interventions that have been developed, in part, because in experiments with animals, they have some of the same biological effects as calorie restriction.”

There remain many unanswered questions.

“There are people who would argue that the reason calorie restriction does what it does is because when people are calorie-restricted, they also tend to restrict the times when they eat,” Dr. Belsky says. “They tend to have these longer fasts during the day.”

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

A new study says we can slow the pace at which we age by 2%-3% if we lower the number of calories we eat by 25%. That may seem like a little benefit for a large cut in calories. But experts say it’s actually a pretty big deal.

“In other studies, that same difference in pace of aging had meaningful consequences for people’s risk of dying,” says senior study author Daniel W. Belsky, PhD, a researcher at the Butler Columbia Aging Center at Columbia University, New York.

Cutting calories by 25% slowed the pace of aging in young and middle-aged adults by a few percentage points, compared with those who continued eating normally, the new research reveals. This first-of-its-kind study in humans adds to evidence from animal studies that the rate of aging can be changed.

Compared with 75 people who ate normally, the 145 people randomly assigned to cut back their calories slowed their pace of aging by 2%-3% over 2 years in the randomized controlled trial.

For example, a similar slowdown in the pace of aging was associated with a 10%-15% lower risk of dying over 10-15 years in previous work, Dr. Belsky says. “So 2%-3% slower aging doesn’t sound like maybe that big of a deal – but 10%-15% reduction in risk of dying seems like a big deal.”

Results of the study were published in the journal Nature Aging.

Even though the pace of aging slowed, the researchers did not find significant changes on two biological aging measures in the study, suggesting more work is needed.

The findings “are intriguing in that caloric restriction seemed to show a slower pace of aging in healthy adults,” says Vandana Sheth, a registered dietitian-nutritionist and owner of a nutrition consulting firm in Los Angeles. “This can have a significant impact on population health. However, larger studies need to be done to follow up on these findings.”


 

‘Exciting result’

Asked if the findings imply aging could be slowed down in people, Dr. Belsky says. “That is the ... exciting result from the trial. These results suggest it may be possible to slow the pace of biological aging with a behavioral intervention.”

But not everyone is completely convinced.

“This is good suggestive evidence that caloric restriction can modify aspects of biological aging in humans, similar to what has been known in laboratory animals for many decades,” says Matt Kaeberlein, PhD, director of the Healthy Aging and Longevity Research Institute at the University of Washington, Seattle, and senior author of a 2021 review article in Science.

Part of his concern is that cutting your calories by a quarter may not be a sustainable long-term strategy.

“It’s important to keep in mind that these measurements only report on a portion of biological aging and are probably not an accurate overall measurement of biological age or the rate of biological aging,” Dr. Kaeberlein says. The findings might suggest that “at the population level, a 25% reduction in caloric intake is unlikely to have large effects on biological aging unless implemented over many years, which is likely not reasonable for most people.”

Insight into intermittent fasting?

Cutting back on calories is related to other dietary strategies, including intermittent fasting and time-restricted eating, Dr. Belsky says. “Intermittent fasting and time-restricted eating are nutritional interventions that have been developed, in part, because in experiments with animals, they have some of the same biological effects as calorie restriction.”

There remain many unanswered questions.

“There are people who would argue that the reason calorie restriction does what it does is because when people are calorie-restricted, they also tend to restrict the times when they eat,” Dr. Belsky says. “They tend to have these longer fasts during the day.”

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

Some time ago I was invited to join a bipartisan congressional task force on valley fever, also known as coccidioidomycosis. A large and diverse crowd attended the task force’s first meeting in Bakersfield, Calif. – a meeting for everyone: the medical profession, the public, it even included veterinarians.

The whole thing was a resounding success. Francis Collins was there, the just-retired director of the NIH. Tom Frieden, then-director of the Centers for Disease Control and Prevention was there, as were several congresspeople and also my college roommate, a retired Navy medical corps captain. I was enjoying it.

Afterward, we had a banquet dinner at a restaurant in downtown Bakersfield. One of the people there was a woman I knew well – her husband was a physician friend. The restaurant served steak and salmon, and this woman made the mistake of ordering the steak.

Not long after the entrees were served, I heard a commotion at the table just behind me. I turned around and saw that woman in distress. A piece of steak had wedged in her trachea and she couldn’t breathe.

Almost immediately, the chef showed up. I don’t know how he got there. The chef at this restaurant was a big guy. I mean, probably 6 feet, 5 inches tall and 275 pounds. He tried the Heimlich maneuver. It didn’t work.

At that point, I jumped up. I thought, “Well, maybe I know how to do this better than him.” Probably not, actually. I tried and couldn’t make it work either. So I knew we were going to have to do something.

Paul Krogstad, my friend and research partner who is a pediatric infectious disease physician, stepped up and tried to put his finger in her throat and dig it out. He couldn’t get it. The patient had lost consciousness.

So, I’m thinking, okay, there’s really only one choice. You have to get an airway surgically.

I said, “We have to put her down on the floor.” And then I said, “Knife!”

I was looking at the steak knives on the table and they weren’t to my liking for doing a procedure. My college roommate – the retired Navy man – whipped out this very good pocketknife.

So, there we were, I had Paul Krogstad holding her head, and CDC Director Tom Frieden taking her pulse, which she still had. I took the knife and did a cricothyroidotomy. I had never done this in my life.

While I was making the incision, somebody gave Paul a ballpoint pen and he broke it into pieces to make a tracheostomy tube. Once I’d made the little incision, I put the tube in. She wasn’t breathing, but she still had a pulse.

I leaned forward and blew into the tube and inflated her lungs. I could see her lungs balloon up. It was a nice feeling, because I knew I was clearly in the right place.

I can’t quite explain it, but while I was doing this, I was enormously calm and totally focused. I knew there was a crowd of people around me, all looking at me, but I wasn’t conscious of that.

It was really just the four of us: Paul and Tom and me and our patient. Those were the only people that I was really cognizant of. Paul and Tom were not panic stricken at all. I remember somebody shouting, “We have to start CPR!” and Frieden said, “No. We don’t.”

Moments later, she woke up, sat up, coughed, and shot the piece of steak across the room.

She was breathing on her own, but we still taped that tube into place. Somebody had already summoned an ambulance; they were there not very long after we completed this procedure. I got in the ambulance with her and we rode over to the emergency room at Mercy Truxtun.

She was stable and doing okay. I sat with her until a thoracic surgeon showed up. He checked out the situation and decided we didn’t need that tube and took it out. I didn’t want to take that out until I had a surgeon there who could do a formal tracheostomy.

They kept her in the hospital for 3 or 4 days. Now, this woman had always had difficulties swallowing, so steak may not have been the best choice. She still had trouble swallowing afterward but recovered.

I’ve known her and her husband a long time, so it was certainly rewarding to be able to provide this service. Years later, though, when her husband died, I spoke at his funeral. When she was speaking to the gathering, she said, “And oh, by the way, Royce, thanks for saving my life.”

That surprised me. I didn’t think we were going to go there.

I’d never tried to practice medicine “at the roadside” before. But that’s part of the career.

Royce Johnson, MD, is the chief of the division of infectious disease among other leadership positions at Kern Medical in Bakersfield, Calif., and the medical director of the Valley Fever Institute.

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

Some time ago I was invited to join a bipartisan congressional task force on valley fever, also known as coccidioidomycosis. A large and diverse crowd attended the task force’s first meeting in Bakersfield, Calif. – a meeting for everyone: the medical profession, the public, it even included veterinarians.

The whole thing was a resounding success. Francis Collins was there, the just-retired director of the NIH. Tom Frieden, then-director of the Centers for Disease Control and Prevention was there, as were several congresspeople and also my college roommate, a retired Navy medical corps captain. I was enjoying it.

Afterward, we had a banquet dinner at a restaurant in downtown Bakersfield. One of the people there was a woman I knew well – her husband was a physician friend. The restaurant served steak and salmon, and this woman made the mistake of ordering the steak.

Not long after the entrees were served, I heard a commotion at the table just behind me. I turned around and saw that woman in distress. A piece of steak had wedged in her trachea and she couldn’t breathe.

Almost immediately, the chef showed up. I don’t know how he got there. The chef at this restaurant was a big guy. I mean, probably 6 feet, 5 inches tall and 275 pounds. He tried the Heimlich maneuver. It didn’t work.

At that point, I jumped up. I thought, “Well, maybe I know how to do this better than him.” Probably not, actually. I tried and couldn’t make it work either. So I knew we were going to have to do something.

Paul Krogstad, my friend and research partner who is a pediatric infectious disease physician, stepped up and tried to put his finger in her throat and dig it out. He couldn’t get it. The patient had lost consciousness.

So, I’m thinking, okay, there’s really only one choice. You have to get an airway surgically.

I said, “We have to put her down on the floor.” And then I said, “Knife!”

I was looking at the steak knives on the table and they weren’t to my liking for doing a procedure. My college roommate – the retired Navy man – whipped out this very good pocketknife.

So, there we were, I had Paul Krogstad holding her head, and CDC Director Tom Frieden taking her pulse, which she still had. I took the knife and did a cricothyroidotomy. I had never done this in my life.

While I was making the incision, somebody gave Paul a ballpoint pen and he broke it into pieces to make a tracheostomy tube. Once I’d made the little incision, I put the tube in. She wasn’t breathing, but she still had a pulse.

I leaned forward and blew into the tube and inflated her lungs. I could see her lungs balloon up. It was a nice feeling, because I knew I was clearly in the right place.

I can’t quite explain it, but while I was doing this, I was enormously calm and totally focused. I knew there was a crowd of people around me, all looking at me, but I wasn’t conscious of that.

It was really just the four of us: Paul and Tom and me and our patient. Those were the only people that I was really cognizant of. Paul and Tom were not panic stricken at all. I remember somebody shouting, “We have to start CPR!” and Frieden said, “No. We don’t.”

Moments later, she woke up, sat up, coughed, and shot the piece of steak across the room.

She was breathing on her own, but we still taped that tube into place. Somebody had already summoned an ambulance; they were there not very long after we completed this procedure. I got in the ambulance with her and we rode over to the emergency room at Mercy Truxtun.

She was stable and doing okay. I sat with her until a thoracic surgeon showed up. He checked out the situation and decided we didn’t need that tube and took it out. I didn’t want to take that out until I had a surgeon there who could do a formal tracheostomy.

They kept her in the hospital for 3 or 4 days. Now, this woman had always had difficulties swallowing, so steak may not have been the best choice. She still had trouble swallowing afterward but recovered.

I’ve known her and her husband a long time, so it was certainly rewarding to be able to provide this service. Years later, though, when her husband died, I spoke at his funeral. When she was speaking to the gathering, she said, “And oh, by the way, Royce, thanks for saving my life.”

That surprised me. I didn’t think we were going to go there.

I’d never tried to practice medicine “at the roadside” before. But that’s part of the career.

Royce Johnson, MD, is the chief of the division of infectious disease among other leadership positions at Kern Medical in Bakersfield, Calif., and the medical director of the Valley Fever Institute.

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

Some time ago I was invited to join a bipartisan congressional task force on valley fever, also known as coccidioidomycosis. A large and diverse crowd attended the task force’s first meeting in Bakersfield, Calif. – a meeting for everyone: the medical profession, the public, it even included veterinarians.

The whole thing was a resounding success. Francis Collins was there, the just-retired director of the NIH. Tom Frieden, then-director of the Centers for Disease Control and Prevention was there, as were several congresspeople and also my college roommate, a retired Navy medical corps captain. I was enjoying it.

Afterward, we had a banquet dinner at a restaurant in downtown Bakersfield. One of the people there was a woman I knew well – her husband was a physician friend. The restaurant served steak and salmon, and this woman made the mistake of ordering the steak.

Not long after the entrees were served, I heard a commotion at the table just behind me. I turned around and saw that woman in distress. A piece of steak had wedged in her trachea and she couldn’t breathe.

Almost immediately, the chef showed up. I don’t know how he got there. The chef at this restaurant was a big guy. I mean, probably 6 feet, 5 inches tall and 275 pounds. He tried the Heimlich maneuver. It didn’t work.

At that point, I jumped up. I thought, “Well, maybe I know how to do this better than him.” Probably not, actually. I tried and couldn’t make it work either. So I knew we were going to have to do something.

Paul Krogstad, my friend and research partner who is a pediatric infectious disease physician, stepped up and tried to put his finger in her throat and dig it out. He couldn’t get it. The patient had lost consciousness.

So, I’m thinking, okay, there’s really only one choice. You have to get an airway surgically.

I said, “We have to put her down on the floor.” And then I said, “Knife!”

I was looking at the steak knives on the table and they weren’t to my liking for doing a procedure. My college roommate – the retired Navy man – whipped out this very good pocketknife.

So, there we were, I had Paul Krogstad holding her head, and CDC Director Tom Frieden taking her pulse, which she still had. I took the knife and did a cricothyroidotomy. I had never done this in my life.

While I was making the incision, somebody gave Paul a ballpoint pen and he broke it into pieces to make a tracheostomy tube. Once I’d made the little incision, I put the tube in. She wasn’t breathing, but she still had a pulse.

I leaned forward and blew into the tube and inflated her lungs. I could see her lungs balloon up. It was a nice feeling, because I knew I was clearly in the right place.

I can’t quite explain it, but while I was doing this, I was enormously calm and totally focused. I knew there was a crowd of people around me, all looking at me, but I wasn’t conscious of that.

It was really just the four of us: Paul and Tom and me and our patient. Those were the only people that I was really cognizant of. Paul and Tom were not panic stricken at all. I remember somebody shouting, “We have to start CPR!” and Frieden said, “No. We don’t.”

Moments later, she woke up, sat up, coughed, and shot the piece of steak across the room.

She was breathing on her own, but we still taped that tube into place. Somebody had already summoned an ambulance; they were there not very long after we completed this procedure. I got in the ambulance with her and we rode over to the emergency room at Mercy Truxtun.

She was stable and doing okay. I sat with her until a thoracic surgeon showed up. He checked out the situation and decided we didn’t need that tube and took it out. I didn’t want to take that out until I had a surgeon there who could do a formal tracheostomy.

They kept her in the hospital for 3 or 4 days. Now, this woman had always had difficulties swallowing, so steak may not have been the best choice. She still had trouble swallowing afterward but recovered.

I’ve known her and her husband a long time, so it was certainly rewarding to be able to provide this service. Years later, though, when her husband died, I spoke at his funeral. When she was speaking to the gathering, she said, “And oh, by the way, Royce, thanks for saving my life.”

That surprised me. I didn’t think we were going to go there.

I’d never tried to practice medicine “at the roadside” before. But that’s part of the career.

Royce Johnson, MD, is the chief of the division of infectious disease among other leadership positions at Kern Medical in Bakersfield, Calif., and the medical director of the Valley Fever Institute.

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

Tenecteplase is as effective as alteplase with respect to disability outcomes and safety in Chinese patients with ischemic stroke, a new study has found. “This was a pivotal trial in establishing the safety and efficacy of tenecteplase as an alternative to alteplase in the thrombolytic treatment of acute ischemic stroke within 4.5 hours in Asian patients,” said study author Shuya Li, MD, associate chief physician, department of neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing.

The findings in this all-Chinese population should have an impact on the use of tenecteplase going forward, said Dr. Li. “The results provide further evidence to support a worldwide switch to tenecteplase as the preferred thrombolytic for acute ischemic stroke.”

The findings were presented at the 2023 International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.
 

Single bolus

Use of alteplase (tissue plasminogen activator [tPA]) has for years been the main approach to thrombolytic reperfusion therapy for patients with acute stroke, but tenecteplase has recently emerged as a potential successor.

Tenecteplase is a tPA produced by recombinant DNA technology. It has a relatively long half-life and can be delivered in a single bolus instead of requiring an hour-long infusion, as is the case with alteplase.

The phase 3 noninferiority Tenecteplase Reperfusion Therapy in Acute ischemic Cerebrovascular Events (TRACE-2) trial – the first of its kind in an Asian population – included 1,430 adult ischemic stroke patients at 53 Chinese centers. Patients had to have a National Institutes of Health Stroke Scale (NIHSS) score of 5-25 and either not be eligible for or have refused endovascular therapy.

The mean age of study participants was about 66 years, and the percentage of women was about 31%. The mean baseline NIHSS score was 7 in both groups, and the symptom-onset-to-needle time was similar at 180 minutes for the tenecteplase group and 178.5 minutes for the alteplase group.

Researchers randomly assigned patients to receive tenecteplase or alteplase within 4.5 hours of symptom onset.

Those in the tenecteplase group received 0.25 mg/kg of the drug in a single IV bolus (maximum dose, 25 mg). Control group members who were treated with alteplase were given the drug as a 10% bolus, with the remainder given as a 1-hour infusion (0.9 mg/kg with a maximum dose of 90 mg).
 

Showed noninferiority

The primary efficacy outcome was a modified Rankins scale (mRS) score of 0-1 at 90 days, which is considered excellent function. About 62% of tenecteplase patients and 58% of alteplase patients attained this outcome (risk ratio, 1.09; 95% confidence interval, 1.00-1.18).

The P value was .001 for noninferiority and .06 for superiority, but Dr. Li explained that these values may change when considering the site effect.

There were no statistically significant differences between the two drugs on secondary outcomes of favorable function. For example, 73% of tenecteplase patients and 72% of alteplase patients had an mRS score of 0-2 at 3 months, and 50% in the tenecteplase and 49% in the alteplase group improved by 4 or more points on the NIHSS, or had a score of 1 or less, at 24 hours.

The groups also had comparable scores on the European quality-of-life visual analogue scale and on the Barthel index, which measures functional independence related to personal care and mobility.

Tenecteplase also turned out to be as safe at alteplase. About 2% in both groups had symptomatic intracranial hemorrhage within 36 hours, and both groups had that same percentage for such hemorrhages within 90 days. As well, the groups had a similar rate of any intracranial hemorrhage within 90 days (6% and 7%).

The mortality rate was 7% in the tenecteplase group, compared with 5% in the alteplase group.

Adverse events (AEs) occurred in 86% and 87%, and serious AEs in 16% and 15%, of the tenecteplase and alteplase groups, respectively, again with no statistically significant differences.

The research team aims to test the effectiveness of tenecteplase in other stroke patients, including those with minor strokes, those receiving thrombolysis in a later window, and those receiving endovascular therapy, said Dr. Li.
 

Strong evidence

Commenting on the study findings, Larry B. Goldstein, MD, professor and chair of neurology, University of Kentucky, Lexington, said it is important to determine the efficacy of tenecteplase among Asians, as they represent “an entirely different population” with unique concerns, such as bleeding complications from anticoagulants.

He noted an advantage of tenecteplase is ease of administration. “You don’t have to go through the loading dose and then the 1-hour infusion,” which poses an “additional hassle” when transferring patients between institutions, he said.

However, he noted that a possible “downside” to having both drugs available in the emergency department is “using the wrong drug at the wrong dose” because of their similar sounding names.

Also commenting on the study, Tudor G. Jovin, MD, professor and chair, department of neurology, Rowan University, Camden, N.J., said he welcomes another trial that confirms that these two drugs are biologically similar.

“I’m very glad this trial was done because it adds another very strong piece of evidence of equivalency.”

But the two drugs are not the same in some important respects, said Dr. Jovin, whose center switched to using tenecteplase almost 3 years ago. That switch has resulted in cutting 17 minutes from the door-to-needle time “which is quite significant,” he said.

“There’s no question that once we used tenecteplase in lieu of tPA, it’s been just so much easier to administer and affects the interhospital transfer protocols, because you’re not transferring the patient with a critical care IV. It’s a win-win situation for everyone.”

The study received funding from the National Science and Technology Major Project, the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, the National Natural Science Foundation of China, and the China Shijiazhuang Pharmaceutical Company Recomgen Pharmaceutical (Guangzhou). Dr. Li, Dr. Goldstein, and Dr. Jovin report no relevant financial relationships.

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

Tenecteplase is as effective as alteplase with respect to disability outcomes and safety in Chinese patients with ischemic stroke, a new study has found. “This was a pivotal trial in establishing the safety and efficacy of tenecteplase as an alternative to alteplase in the thrombolytic treatment of acute ischemic stroke within 4.5 hours in Asian patients,” said study author Shuya Li, MD, associate chief physician, department of neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing.

The findings in this all-Chinese population should have an impact on the use of tenecteplase going forward, said Dr. Li. “The results provide further evidence to support a worldwide switch to tenecteplase as the preferred thrombolytic for acute ischemic stroke.”

The findings were presented at the 2023 International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.
 

Single bolus

Use of alteplase (tissue plasminogen activator [tPA]) has for years been the main approach to thrombolytic reperfusion therapy for patients with acute stroke, but tenecteplase has recently emerged as a potential successor.

Tenecteplase is a tPA produced by recombinant DNA technology. It has a relatively long half-life and can be delivered in a single bolus instead of requiring an hour-long infusion, as is the case with alteplase.

The phase 3 noninferiority Tenecteplase Reperfusion Therapy in Acute ischemic Cerebrovascular Events (TRACE-2) trial – the first of its kind in an Asian population – included 1,430 adult ischemic stroke patients at 53 Chinese centers. Patients had to have a National Institutes of Health Stroke Scale (NIHSS) score of 5-25 and either not be eligible for or have refused endovascular therapy.

The mean age of study participants was about 66 years, and the percentage of women was about 31%. The mean baseline NIHSS score was 7 in both groups, and the symptom-onset-to-needle time was similar at 180 minutes for the tenecteplase group and 178.5 minutes for the alteplase group.

Researchers randomly assigned patients to receive tenecteplase or alteplase within 4.5 hours of symptom onset.

Those in the tenecteplase group received 0.25 mg/kg of the drug in a single IV bolus (maximum dose, 25 mg). Control group members who were treated with alteplase were given the drug as a 10% bolus, with the remainder given as a 1-hour infusion (0.9 mg/kg with a maximum dose of 90 mg).
 

Showed noninferiority

The primary efficacy outcome was a modified Rankins scale (mRS) score of 0-1 at 90 days, which is considered excellent function. About 62% of tenecteplase patients and 58% of alteplase patients attained this outcome (risk ratio, 1.09; 95% confidence interval, 1.00-1.18).

The P value was .001 for noninferiority and .06 for superiority, but Dr. Li explained that these values may change when considering the site effect.

There were no statistically significant differences between the two drugs on secondary outcomes of favorable function. For example, 73% of tenecteplase patients and 72% of alteplase patients had an mRS score of 0-2 at 3 months, and 50% in the tenecteplase and 49% in the alteplase group improved by 4 or more points on the NIHSS, or had a score of 1 or less, at 24 hours.

The groups also had comparable scores on the European quality-of-life visual analogue scale and on the Barthel index, which measures functional independence related to personal care and mobility.

Tenecteplase also turned out to be as safe at alteplase. About 2% in both groups had symptomatic intracranial hemorrhage within 36 hours, and both groups had that same percentage for such hemorrhages within 90 days. As well, the groups had a similar rate of any intracranial hemorrhage within 90 days (6% and 7%).

The mortality rate was 7% in the tenecteplase group, compared with 5% in the alteplase group.

Adverse events (AEs) occurred in 86% and 87%, and serious AEs in 16% and 15%, of the tenecteplase and alteplase groups, respectively, again with no statistically significant differences.

The research team aims to test the effectiveness of tenecteplase in other stroke patients, including those with minor strokes, those receiving thrombolysis in a later window, and those receiving endovascular therapy, said Dr. Li.
 

Strong evidence

Commenting on the study findings, Larry B. Goldstein, MD, professor and chair of neurology, University of Kentucky, Lexington, said it is important to determine the efficacy of tenecteplase among Asians, as they represent “an entirely different population” with unique concerns, such as bleeding complications from anticoagulants.

He noted an advantage of tenecteplase is ease of administration. “You don’t have to go through the loading dose and then the 1-hour infusion,” which poses an “additional hassle” when transferring patients between institutions, he said.

However, he noted that a possible “downside” to having both drugs available in the emergency department is “using the wrong drug at the wrong dose” because of their similar sounding names.

Also commenting on the study, Tudor G. Jovin, MD, professor and chair, department of neurology, Rowan University, Camden, N.J., said he welcomes another trial that confirms that these two drugs are biologically similar.

“I’m very glad this trial was done because it adds another very strong piece of evidence of equivalency.”

But the two drugs are not the same in some important respects, said Dr. Jovin, whose center switched to using tenecteplase almost 3 years ago. That switch has resulted in cutting 17 minutes from the door-to-needle time “which is quite significant,” he said.

“There’s no question that once we used tenecteplase in lieu of tPA, it’s been just so much easier to administer and affects the interhospital transfer protocols, because you’re not transferring the patient with a critical care IV. It’s a win-win situation for everyone.”

The study received funding from the National Science and Technology Major Project, the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, the National Natural Science Foundation of China, and the China Shijiazhuang Pharmaceutical Company Recomgen Pharmaceutical (Guangzhou). Dr. Li, Dr. Goldstein, and Dr. Jovin report no relevant financial relationships.

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

Tenecteplase is as effective as alteplase with respect to disability outcomes and safety in Chinese patients with ischemic stroke, a new study has found. “This was a pivotal trial in establishing the safety and efficacy of tenecteplase as an alternative to alteplase in the thrombolytic treatment of acute ischemic stroke within 4.5 hours in Asian patients,” said study author Shuya Li, MD, associate chief physician, department of neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing.

The findings in this all-Chinese population should have an impact on the use of tenecteplase going forward, said Dr. Li. “The results provide further evidence to support a worldwide switch to tenecteplase as the preferred thrombolytic for acute ischemic stroke.”

The findings were presented at the 2023 International Stroke Conference presented by the American Stroke Association, a division of the American Heart Association.
 

Single bolus

Use of alteplase (tissue plasminogen activator [tPA]) has for years been the main approach to thrombolytic reperfusion therapy for patients with acute stroke, but tenecteplase has recently emerged as a potential successor.

Tenecteplase is a tPA produced by recombinant DNA technology. It has a relatively long half-life and can be delivered in a single bolus instead of requiring an hour-long infusion, as is the case with alteplase.

The phase 3 noninferiority Tenecteplase Reperfusion Therapy in Acute ischemic Cerebrovascular Events (TRACE-2) trial – the first of its kind in an Asian population – included 1,430 adult ischemic stroke patients at 53 Chinese centers. Patients had to have a National Institutes of Health Stroke Scale (NIHSS) score of 5-25 and either not be eligible for or have refused endovascular therapy.

The mean age of study participants was about 66 years, and the percentage of women was about 31%. The mean baseline NIHSS score was 7 in both groups, and the symptom-onset-to-needle time was similar at 180 minutes for the tenecteplase group and 178.5 minutes for the alteplase group.

Researchers randomly assigned patients to receive tenecteplase or alteplase within 4.5 hours of symptom onset.

Those in the tenecteplase group received 0.25 mg/kg of the drug in a single IV bolus (maximum dose, 25 mg). Control group members who were treated with alteplase were given the drug as a 10% bolus, with the remainder given as a 1-hour infusion (0.9 mg/kg with a maximum dose of 90 mg).
 

Showed noninferiority

The primary efficacy outcome was a modified Rankins scale (mRS) score of 0-1 at 90 days, which is considered excellent function. About 62% of tenecteplase patients and 58% of alteplase patients attained this outcome (risk ratio, 1.09; 95% confidence interval, 1.00-1.18).

The P value was .001 for noninferiority and .06 for superiority, but Dr. Li explained that these values may change when considering the site effect.

There were no statistically significant differences between the two drugs on secondary outcomes of favorable function. For example, 73% of tenecteplase patients and 72% of alteplase patients had an mRS score of 0-2 at 3 months, and 50% in the tenecteplase and 49% in the alteplase group improved by 4 or more points on the NIHSS, or had a score of 1 or less, at 24 hours.

The groups also had comparable scores on the European quality-of-life visual analogue scale and on the Barthel index, which measures functional independence related to personal care and mobility.

Tenecteplase also turned out to be as safe at alteplase. About 2% in both groups had symptomatic intracranial hemorrhage within 36 hours, and both groups had that same percentage for such hemorrhages within 90 days. As well, the groups had a similar rate of any intracranial hemorrhage within 90 days (6% and 7%).

The mortality rate was 7% in the tenecteplase group, compared with 5% in the alteplase group.

Adverse events (AEs) occurred in 86% and 87%, and serious AEs in 16% and 15%, of the tenecteplase and alteplase groups, respectively, again with no statistically significant differences.

The research team aims to test the effectiveness of tenecteplase in other stroke patients, including those with minor strokes, those receiving thrombolysis in a later window, and those receiving endovascular therapy, said Dr. Li.
 

Strong evidence

Commenting on the study findings, Larry B. Goldstein, MD, professor and chair of neurology, University of Kentucky, Lexington, said it is important to determine the efficacy of tenecteplase among Asians, as they represent “an entirely different population” with unique concerns, such as bleeding complications from anticoagulants.

He noted an advantage of tenecteplase is ease of administration. “You don’t have to go through the loading dose and then the 1-hour infusion,” which poses an “additional hassle” when transferring patients between institutions, he said.

However, he noted that a possible “downside” to having both drugs available in the emergency department is “using the wrong drug at the wrong dose” because of their similar sounding names.

Also commenting on the study, Tudor G. Jovin, MD, professor and chair, department of neurology, Rowan University, Camden, N.J., said he welcomes another trial that confirms that these two drugs are biologically similar.

“I’m very glad this trial was done because it adds another very strong piece of evidence of equivalency.”

But the two drugs are not the same in some important respects, said Dr. Jovin, whose center switched to using tenecteplase almost 3 years ago. That switch has resulted in cutting 17 minutes from the door-to-needle time “which is quite significant,” he said.

“There’s no question that once we used tenecteplase in lieu of tPA, it’s been just so much easier to administer and affects the interhospital transfer protocols, because you’re not transferring the patient with a critical care IV. It’s a win-win situation for everyone.”

The study received funding from the National Science and Technology Major Project, the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences, the National Natural Science Foundation of China, and the China Shijiazhuang Pharmaceutical Company Recomgen Pharmaceutical (Guangzhou). Dr. Li, Dr. Goldstein, and Dr. Jovin report no relevant financial relationships.

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

In patients with early-phase schizophrenia, long-acting injectable antipsychotics (LAIs) provide no benefit over oral antipsychotics (OAs) in preventing discontinuation of antipsychotic treatment, new research suggests.

In a multicountry, randomized, open-label study of more than 500 adults with schizophrenia, participants received either LAI paliperidone, LAI aripiprazole, or the respective oral formulation of these antipsychotics.

Results showed no significant difference between the combined oral and combined LAI treatment groups in time to all-cause discontinuation.

“We found no substantial advantage for LAI antipsychotic treatment over oral treatment, regarding time to discontinuation in patients with early-phase schizophrenia,” write investigators, led by Inge Winter-van Rossum, PhD, assistant visiting professor at Mount Sinai, New York, and affiliated with King’s College London and UMC Utrecht (the Netherlands).

This indicates that “there is no reason to prescribe LAIs instead of oral antipsychotics if the goal is to prevent discontinuation of antipsychotic medication in daily clinical practice,” they add.

The findings were published online in The Lancet Psychiatry.
 

Previous conflicting results

Maintenance treatment with antipsychotic medication reduces risk for relapse considerably, with treatment discontinuation being “by far the most important reason for relapse,” the investigators write.

LAIs “seem theoretically to be a way to enhance medication continuation and thereby reduce the risk for relapse,” they add. This is because LAIs enable a rapid response to nonadherence and remove the need for patients to remember to take their medications on a daily basis.

However, previous research has “provided conflicting results,” regarding the effectiveness of LAIs in accomplishing this. Moreover, the subject has not been thoroughly investigated in early-stage schizophrenia, the researchers note.

Therefore, they decided to conduct the EULAST study to compare LAI and oral formulations in terms of all-cause discontinuation.

The trial was conducted at 50 general hospitals and psychiatric specialty clinics located in 15 European countries and Israel and included 511 participants in the intention-to-treat sample (67% men; mean age, 30.5 years).

All were randomly assigned 1:1:1 to receive either LAI paliperidone, LAI aripiprazole, or their respective oral formulations.

The combined OA treatment group consisted of 247 patients; the combined LAI group consisted of 264 patients.

Randomization was stratified by country and illness duration (5 months to 3 years vs. 4-7 years). Participants were followed up to 19 months, with all-cause discontinuation during that time serving as the primary endpoint.

All-cause discontinuation was defined as the allocated treatment was stopped or used at doses outside the allowed range, medication was switched or augmented with another antipsychotic after visit four, the patient missed a monthly visit and did not show up after being reminded, the patient withdrew consent for the study, or the clinician withdrew the patient from the study.

After the baseline visit, patients already taking antipsychotics were also randomly assigned. The next 4 weeks were then used to cross-taper between the prestudy antipsychotic and the agent they would be treated with during the study.
 

LAIs not superior

Results showed the LAI group did not have lower rates of hospitalization.

In addition, the discontinuation rates between the two combined groups were very similar at 71% for the oral antipsychotics group versus 64% in the LAIs group (hazard ratio, 1.6; 95% confidence interval, 0.94-1.43; P = .18).

Moreover, “no significant difference was found in the time to all-cause discontinuation between the combined oral and combined LAI treatment groups (P = .17),” the researchers report.

Reasons for discontinuation also did not differ significantly between the groups: 12% of patients in the OA group discontinued treatment because of efficacy vs. 17% of patients in the combined LAI group. The difference was not significant and the time to discontinuation also did not differ.

The main reason for discontinuation in both groups was safety concerns, affecting 10% and 13% of the combined OA and LAI groups, respectively, which was not a significant between-group difference.

Illness duration had a significant effect on time to all-cause discontinuation, with patients who had longer illness duration showing a poorer response, compared with those who had shorter duration (HR, 1.26; 95% CI, 1.01-1.56; P = .038).

However, stratifying participants by illness duration showed no significant difference between the subgroups (P = .25 and .34, respectively).

There was a significant between-group difference in discontinuation due to “other reasons,” with 49% vs. 34% of patients in the OA and LAI groups, respectively, discontinuing (HR, 1.51; 95% CI, 1.15-1.98; P = .0034). Moreover, the LAI group showed significantly longer continued use of medication vs the OA group (P = .0029).

“After separating the reasons for discontinuation into no efficacy, safety reasons, and other reasons, we only found a significant difference in favor of LAI for the ‘other reasons’ category; although the number of patients discontinuing medication for this reason over the follow-up period did not differ, patients on LAI continued treatment for a longer time,” the investigators write.

They acknowledge that this finding is “difficult to interpret, given the wide variety of reasons for discontinuation captured in this category,” which prevented an “informative subgroup analysis.”

Nevertheless, since there is “no consistent evidence supporting the use of LAI over oral antipsychotics” in patients with early-phase schizophrenia, their use should be “carefully considered on an individual risk-benefit basis,” they conclude.
 

No ‘real-world’ implications?

John M. Kane, MD, codirector and professor, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., said that overall, this was a “large, potentially valuable study.” However, he raised several concerns.

“I think the investigators made a much too emphatic statement about the lack of value of LAIs in early-phase patients when discontinuation is the primary outcome,” he said, noting that other studies have come to the opposite conclusion.

Dr. Kane, who is also a professor of psychiatry at Hofstra/Northwell, New York, was not involved with the current research.

“RCTs [randomized controlled trials] in general are not necessarily the best way to evaluate the impact of LAIs [which] usually represent a small percentage of potentially eligible patients and are likely to include patients who are more adherent than those who would not agree to participate in an RCT,” he said. He added that the investigators “did not report on how many patients were screened and refused to be considered.”

Also, Dr. Kane noted that half of the participants were recruited from inpatient services, and so may have been “more unstable” at baseline. “Patients with residual positive symptoms are more likely to relapse on LAIs than patients who are in remission. This could potentially reduce the advantage of the LAI,” he said.

In addition, he took issue with the definition of all-cause discontinuation, which included the need for augmentation with another antipsychotic or use outside the normal range.

“This happens often in clinical practice. If someone’s symptoms aren’t sufficiently controlled by an LAI alone, for example, they often receive more of that antipsychotic or another drug. This perhaps makes the EULAST study somewhat less ‘real-world’,” Dr. Kane said.
 

More information needed

In an accompanying editorial, Martina Hahn, PharmD, PhD, department of psychiatry, psychosomatics, and psychotherapy, University Hospital-Goethe University, Frankfurt, Germany, and Sibylle Christine Roll, MD, PHD, department of mental health, Varisano Hospital in Frankfurt, note that comedications were neither documented nor analyzed by the researchers.

“Drug-drug interactions could be responsible for relapse or poor tolerability,” they write.

Moreover, pharmacogenetic information was not available nor were serum concentrations that could have been used for dose optimization after switching antipsychotic formulations, they note.

This information would have provided “a deeper understanding of why some patients do not respond or show side effects,” the editorialists write. “The use of therapeutic drug monitoring, drug interaction checks, and pharmacogenetic testing could improve treatment outcomes in both study settings and clinical practice.”

Financial support and study medication was provided by Lundbeck and Otsuka. Dr. Winter-van Rossum reports no relevant financial relationships. Disclosures for the other investigators are fully listed in the original paper. Dr. Kane is or has been a consultant to or received honoraria for lectures from Alkermes , Biogen, Boehringer Ingelheim, Cerevel, Dainippon Sumitomo, H. Lundbeck, HLS, Intracellular Therapies, Janssen, Karuna, Merck, Newron, Otsuka, Roche, Saladax, Sunovion, and TEVA. He is also a shareholder in The Vanguard Research Group, LB Pharma, Health Rhythms, North Shore Therapeutics, and Medincell. Dr. Hahn reports having received honoraria for lecture from Otsuka and advisory board participation for Rovi. Dr. Roll reports advisory board participation for Recordati, Otsuka, and Janssen.

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

In patients with early-phase schizophrenia, long-acting injectable antipsychotics (LAIs) provide no benefit over oral antipsychotics (OAs) in preventing discontinuation of antipsychotic treatment, new research suggests.

In a multicountry, randomized, open-label study of more than 500 adults with schizophrenia, participants received either LAI paliperidone, LAI aripiprazole, or the respective oral formulation of these antipsychotics.

Results showed no significant difference between the combined oral and combined LAI treatment groups in time to all-cause discontinuation.

“We found no substantial advantage for LAI antipsychotic treatment over oral treatment, regarding time to discontinuation in patients with early-phase schizophrenia,” write investigators, led by Inge Winter-van Rossum, PhD, assistant visiting professor at Mount Sinai, New York, and affiliated with King’s College London and UMC Utrecht (the Netherlands).

This indicates that “there is no reason to prescribe LAIs instead of oral antipsychotics if the goal is to prevent discontinuation of antipsychotic medication in daily clinical practice,” they add.

The findings were published online in The Lancet Psychiatry.
 

Previous conflicting results

Maintenance treatment with antipsychotic medication reduces risk for relapse considerably, with treatment discontinuation being “by far the most important reason for relapse,” the investigators write.

LAIs “seem theoretically to be a way to enhance medication continuation and thereby reduce the risk for relapse,” they add. This is because LAIs enable a rapid response to nonadherence and remove the need for patients to remember to take their medications on a daily basis.

However, previous research has “provided conflicting results,” regarding the effectiveness of LAIs in accomplishing this. Moreover, the subject has not been thoroughly investigated in early-stage schizophrenia, the researchers note.

Therefore, they decided to conduct the EULAST study to compare LAI and oral formulations in terms of all-cause discontinuation.

The trial was conducted at 50 general hospitals and psychiatric specialty clinics located in 15 European countries and Israel and included 511 participants in the intention-to-treat sample (67% men; mean age, 30.5 years).

All were randomly assigned 1:1:1 to receive either LAI paliperidone, LAI aripiprazole, or their respective oral formulations.

The combined OA treatment group consisted of 247 patients; the combined LAI group consisted of 264 patients.

Randomization was stratified by country and illness duration (5 months to 3 years vs. 4-7 years). Participants were followed up to 19 months, with all-cause discontinuation during that time serving as the primary endpoint.

All-cause discontinuation was defined as the allocated treatment was stopped or used at doses outside the allowed range, medication was switched or augmented with another antipsychotic after visit four, the patient missed a monthly visit and did not show up after being reminded, the patient withdrew consent for the study, or the clinician withdrew the patient from the study.

After the baseline visit, patients already taking antipsychotics were also randomly assigned. The next 4 weeks were then used to cross-taper between the prestudy antipsychotic and the agent they would be treated with during the study.
 

LAIs not superior

Results showed the LAI group did not have lower rates of hospitalization.

In addition, the discontinuation rates between the two combined groups were very similar at 71% for the oral antipsychotics group versus 64% in the LAIs group (hazard ratio, 1.6; 95% confidence interval, 0.94-1.43; P = .18).

Moreover, “no significant difference was found in the time to all-cause discontinuation between the combined oral and combined LAI treatment groups (P = .17),” the researchers report.

Reasons for discontinuation also did not differ significantly between the groups: 12% of patients in the OA group discontinued treatment because of efficacy vs. 17% of patients in the combined LAI group. The difference was not significant and the time to discontinuation also did not differ.

The main reason for discontinuation in both groups was safety concerns, affecting 10% and 13% of the combined OA and LAI groups, respectively, which was not a significant between-group difference.

Illness duration had a significant effect on time to all-cause discontinuation, with patients who had longer illness duration showing a poorer response, compared with those who had shorter duration (HR, 1.26; 95% CI, 1.01-1.56; P = .038).

However, stratifying participants by illness duration showed no significant difference between the subgroups (P = .25 and .34, respectively).

There was a significant between-group difference in discontinuation due to “other reasons,” with 49% vs. 34% of patients in the OA and LAI groups, respectively, discontinuing (HR, 1.51; 95% CI, 1.15-1.98; P = .0034). Moreover, the LAI group showed significantly longer continued use of medication vs the OA group (P = .0029).

“After separating the reasons for discontinuation into no efficacy, safety reasons, and other reasons, we only found a significant difference in favor of LAI for the ‘other reasons’ category; although the number of patients discontinuing medication for this reason over the follow-up period did not differ, patients on LAI continued treatment for a longer time,” the investigators write.

They acknowledge that this finding is “difficult to interpret, given the wide variety of reasons for discontinuation captured in this category,” which prevented an “informative subgroup analysis.”

Nevertheless, since there is “no consistent evidence supporting the use of LAI over oral antipsychotics” in patients with early-phase schizophrenia, their use should be “carefully considered on an individual risk-benefit basis,” they conclude.
 

No ‘real-world’ implications?

John M. Kane, MD, codirector and professor, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., said that overall, this was a “large, potentially valuable study.” However, he raised several concerns.

“I think the investigators made a much too emphatic statement about the lack of value of LAIs in early-phase patients when discontinuation is the primary outcome,” he said, noting that other studies have come to the opposite conclusion.

Dr. Kane, who is also a professor of psychiatry at Hofstra/Northwell, New York, was not involved with the current research.

“RCTs [randomized controlled trials] in general are not necessarily the best way to evaluate the impact of LAIs [which] usually represent a small percentage of potentially eligible patients and are likely to include patients who are more adherent than those who would not agree to participate in an RCT,” he said. He added that the investigators “did not report on how many patients were screened and refused to be considered.”

Also, Dr. Kane noted that half of the participants were recruited from inpatient services, and so may have been “more unstable” at baseline. “Patients with residual positive symptoms are more likely to relapse on LAIs than patients who are in remission. This could potentially reduce the advantage of the LAI,” he said.

In addition, he took issue with the definition of all-cause discontinuation, which included the need for augmentation with another antipsychotic or use outside the normal range.

“This happens often in clinical practice. If someone’s symptoms aren’t sufficiently controlled by an LAI alone, for example, they often receive more of that antipsychotic or another drug. This perhaps makes the EULAST study somewhat less ‘real-world’,” Dr. Kane said.
 

More information needed

In an accompanying editorial, Martina Hahn, PharmD, PhD, department of psychiatry, psychosomatics, and psychotherapy, University Hospital-Goethe University, Frankfurt, Germany, and Sibylle Christine Roll, MD, PHD, department of mental health, Varisano Hospital in Frankfurt, note that comedications were neither documented nor analyzed by the researchers.

“Drug-drug interactions could be responsible for relapse or poor tolerability,” they write.

Moreover, pharmacogenetic information was not available nor were serum concentrations that could have been used for dose optimization after switching antipsychotic formulations, they note.

This information would have provided “a deeper understanding of why some patients do not respond or show side effects,” the editorialists write. “The use of therapeutic drug monitoring, drug interaction checks, and pharmacogenetic testing could improve treatment outcomes in both study settings and clinical practice.”

Financial support and study medication was provided by Lundbeck and Otsuka. Dr. Winter-van Rossum reports no relevant financial relationships. Disclosures for the other investigators are fully listed in the original paper. Dr. Kane is or has been a consultant to or received honoraria for lectures from Alkermes , Biogen, Boehringer Ingelheim, Cerevel, Dainippon Sumitomo, H. Lundbeck, HLS, Intracellular Therapies, Janssen, Karuna, Merck, Newron, Otsuka, Roche, Saladax, Sunovion, and TEVA. He is also a shareholder in The Vanguard Research Group, LB Pharma, Health Rhythms, North Shore Therapeutics, and Medincell. Dr. Hahn reports having received honoraria for lecture from Otsuka and advisory board participation for Rovi. Dr. Roll reports advisory board participation for Recordati, Otsuka, and Janssen.

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

In patients with early-phase schizophrenia, long-acting injectable antipsychotics (LAIs) provide no benefit over oral antipsychotics (OAs) in preventing discontinuation of antipsychotic treatment, new research suggests.

In a multicountry, randomized, open-label study of more than 500 adults with schizophrenia, participants received either LAI paliperidone, LAI aripiprazole, or the respective oral formulation of these antipsychotics.

Results showed no significant difference between the combined oral and combined LAI treatment groups in time to all-cause discontinuation.

“We found no substantial advantage for LAI antipsychotic treatment over oral treatment, regarding time to discontinuation in patients with early-phase schizophrenia,” write investigators, led by Inge Winter-van Rossum, PhD, assistant visiting professor at Mount Sinai, New York, and affiliated with King’s College London and UMC Utrecht (the Netherlands).

This indicates that “there is no reason to prescribe LAIs instead of oral antipsychotics if the goal is to prevent discontinuation of antipsychotic medication in daily clinical practice,” they add.

The findings were published online in The Lancet Psychiatry.
 

Previous conflicting results

Maintenance treatment with antipsychotic medication reduces risk for relapse considerably, with treatment discontinuation being “by far the most important reason for relapse,” the investigators write.

LAIs “seem theoretically to be a way to enhance medication continuation and thereby reduce the risk for relapse,” they add. This is because LAIs enable a rapid response to nonadherence and remove the need for patients to remember to take their medications on a daily basis.

However, previous research has “provided conflicting results,” regarding the effectiveness of LAIs in accomplishing this. Moreover, the subject has not been thoroughly investigated in early-stage schizophrenia, the researchers note.

Therefore, they decided to conduct the EULAST study to compare LAI and oral formulations in terms of all-cause discontinuation.

The trial was conducted at 50 general hospitals and psychiatric specialty clinics located in 15 European countries and Israel and included 511 participants in the intention-to-treat sample (67% men; mean age, 30.5 years).

All were randomly assigned 1:1:1 to receive either LAI paliperidone, LAI aripiprazole, or their respective oral formulations.

The combined OA treatment group consisted of 247 patients; the combined LAI group consisted of 264 patients.

Randomization was stratified by country and illness duration (5 months to 3 years vs. 4-7 years). Participants were followed up to 19 months, with all-cause discontinuation during that time serving as the primary endpoint.

All-cause discontinuation was defined as the allocated treatment was stopped or used at doses outside the allowed range, medication was switched or augmented with another antipsychotic after visit four, the patient missed a monthly visit and did not show up after being reminded, the patient withdrew consent for the study, or the clinician withdrew the patient from the study.

After the baseline visit, patients already taking antipsychotics were also randomly assigned. The next 4 weeks were then used to cross-taper between the prestudy antipsychotic and the agent they would be treated with during the study.
 

LAIs not superior

Results showed the LAI group did not have lower rates of hospitalization.

In addition, the discontinuation rates between the two combined groups were very similar at 71% for the oral antipsychotics group versus 64% in the LAIs group (hazard ratio, 1.6; 95% confidence interval, 0.94-1.43; P = .18).

Moreover, “no significant difference was found in the time to all-cause discontinuation between the combined oral and combined LAI treatment groups (P = .17),” the researchers report.

Reasons for discontinuation also did not differ significantly between the groups: 12% of patients in the OA group discontinued treatment because of efficacy vs. 17% of patients in the combined LAI group. The difference was not significant and the time to discontinuation also did not differ.

The main reason for discontinuation in both groups was safety concerns, affecting 10% and 13% of the combined OA and LAI groups, respectively, which was not a significant between-group difference.

Illness duration had a significant effect on time to all-cause discontinuation, with patients who had longer illness duration showing a poorer response, compared with those who had shorter duration (HR, 1.26; 95% CI, 1.01-1.56; P = .038).

However, stratifying participants by illness duration showed no significant difference between the subgroups (P = .25 and .34, respectively).

There was a significant between-group difference in discontinuation due to “other reasons,” with 49% vs. 34% of patients in the OA and LAI groups, respectively, discontinuing (HR, 1.51; 95% CI, 1.15-1.98; P = .0034). Moreover, the LAI group showed significantly longer continued use of medication vs the OA group (P = .0029).

“After separating the reasons for discontinuation into no efficacy, safety reasons, and other reasons, we only found a significant difference in favor of LAI for the ‘other reasons’ category; although the number of patients discontinuing medication for this reason over the follow-up period did not differ, patients on LAI continued treatment for a longer time,” the investigators write.

They acknowledge that this finding is “difficult to interpret, given the wide variety of reasons for discontinuation captured in this category,” which prevented an “informative subgroup analysis.”

Nevertheless, since there is “no consistent evidence supporting the use of LAI over oral antipsychotics” in patients with early-phase schizophrenia, their use should be “carefully considered on an individual risk-benefit basis,” they conclude.
 

No ‘real-world’ implications?

John M. Kane, MD, codirector and professor, Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, N.Y., said that overall, this was a “large, potentially valuable study.” However, he raised several concerns.

“I think the investigators made a much too emphatic statement about the lack of value of LAIs in early-phase patients when discontinuation is the primary outcome,” he said, noting that other studies have come to the opposite conclusion.

Dr. Kane, who is also a professor of psychiatry at Hofstra/Northwell, New York, was not involved with the current research.

“RCTs [randomized controlled trials] in general are not necessarily the best way to evaluate the impact of LAIs [which] usually represent a small percentage of potentially eligible patients and are likely to include patients who are more adherent than those who would not agree to participate in an RCT,” he said. He added that the investigators “did not report on how many patients were screened and refused to be considered.”

Also, Dr. Kane noted that half of the participants were recruited from inpatient services, and so may have been “more unstable” at baseline. “Patients with residual positive symptoms are more likely to relapse on LAIs than patients who are in remission. This could potentially reduce the advantage of the LAI,” he said.

In addition, he took issue with the definition of all-cause discontinuation, which included the need for augmentation with another antipsychotic or use outside the normal range.

“This happens often in clinical practice. If someone’s symptoms aren’t sufficiently controlled by an LAI alone, for example, they often receive more of that antipsychotic or another drug. This perhaps makes the EULAST study somewhat less ‘real-world’,” Dr. Kane said.
 

More information needed

In an accompanying editorial, Martina Hahn, PharmD, PhD, department of psychiatry, psychosomatics, and psychotherapy, University Hospital-Goethe University, Frankfurt, Germany, and Sibylle Christine Roll, MD, PHD, department of mental health, Varisano Hospital in Frankfurt, note that comedications were neither documented nor analyzed by the researchers.

“Drug-drug interactions could be responsible for relapse or poor tolerability,” they write.

Moreover, pharmacogenetic information was not available nor were serum concentrations that could have been used for dose optimization after switching antipsychotic formulations, they note.

This information would have provided “a deeper understanding of why some patients do not respond or show side effects,” the editorialists write. “The use of therapeutic drug monitoring, drug interaction checks, and pharmacogenetic testing could improve treatment outcomes in both study settings and clinical practice.”

Financial support and study medication was provided by Lundbeck and Otsuka. Dr. Winter-van Rossum reports no relevant financial relationships. Disclosures for the other investigators are fully listed in the original paper. Dr. Kane is or has been a consultant to or received honoraria for lectures from Alkermes , Biogen, Boehringer Ingelheim, Cerevel, Dainippon Sumitomo, H. Lundbeck, HLS, Intracellular Therapies, Janssen, Karuna, Merck, Newron, Otsuka, Roche, Saladax, Sunovion, and TEVA. He is also a shareholder in The Vanguard Research Group, LB Pharma, Health Rhythms, North Shore Therapeutics, and Medincell. Dr. Hahn reports having received honoraria for lecture from Otsuka and advisory board participation for Rovi. Dr. Roll reports advisory board participation for Recordati, Otsuka, and Janssen.

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

We’re gonna need a bigger meth lab

In case you’ve been living under a rock for the past 15 years, the TV show “Breaking Bad” details the spiraling rise and downfall of a high school chemistry teacher who, after developing a case of terminal lung cancer, starts producing methamphetamine to provide for his family in response to the steep cost of treatment for his cancer.

TheaDesign/Thinkstock

Meanwhile, here in 2023 in the real world, we have Paul Davis, a retired physician in Ohio, who’s being forced to choose between an expensive cancer treatment and bankrupting his family, since Medicare’s decided it doesn’t want to cover the cost. Hey, we’ve seen this one before!

A bit of backstory: In November 2019, Dr. Davis was diagnosed with uveal melanoma, a very rare type of cancer that affects eye tissue. The news got worse in 2022 when the cancer spread to his liver, a move which typically proves fatal within a year. However, in a stroke of great news, the Food and Drug Administration approved the drug Kimmtrak earlier that year, which could be used to treat his cancer. Not cure, of course, but it would give him more time.

His initial treatments with the drug went fine and were covered, but when he transferred his care from a hospital in Columbus to one closer to home, big problem. Medicare decided it didn’t like that hospital and abruptly cut off coverage, denying the local hospital’s claims. That leaves Dr. Davis on the hook for his cancer treatment, and it’s what you might call expensive. Expensive to the tune of $50,000.

A week.

Apparently the coding the local hospital submitted was wrong, indicating that Dr. Davis was receiving Kimmtrak for a type of cancer that the FDA hadn’t approved the drug for. So until the government bureaucracy works itself out, his treatment is on hold, leaving all his faith in Medicare working quickly to rectify its mistake. If it can rectify its mistake. We’re not hopeful.

And in case you were wondering, if Dr. Davis wanted to go full Walter White, the average street price of meth is about $20-$60 per gram, so to pay for his treatment, he’d need to make at least a kilogram of meth every week. That’s, uh, quite a lot of illegal drug, or what we here at the LOTME office would call a fun Saturday night.
 

When you give a mouse a movie

Researchers have been successfully testing Alzheimer drugs on mice for years, but none of the drugs has proved successful in humans. Recent work, however, might have found the missing link, and it’s a combination no one ever thought of before: mice and movies.

procesocreativo/PxHere

Turns out that Orson Welles’ 1958 film noir classic “Touch of Evil” tapped a part of the mouse brain that has been overlooked: the hippocampus, which is crucial for learning and memory. Previous researchers thought it was just used as a kind of GPS system, but that’s only partially true.

Not only did the mice choose to pay attention to the movie clip, but the hippocampus responded to the visual stimuli only when the rodents saw the scenes from the clip later in the order that they were presented and not in a scrambled order. These findings represent a “major paradigm shift” in studying mouse recall, Mayank Mehta, PhD, of the University of California, Los Angeles, said in a statement from the school.

This breakthrough could run parallel to Alzheimer’s patients struggling with similar defects. “Selective and episodic activation of the mouse hippocampus using a human movie opens up the possibility of directly testing human episodic memory disorders and therapies using mouse neurons, a major step forward,” said coauthor Chinmay Purandare, PhD, who is now at the University of California, San Francisco.

Who would have thought that a classic film would help advance Alzheimer research?
 

A less human way to study mosquitoes

We here at LOTME have a history with mosquitoes. We know they don’t like us, and they know that we don’t like them. Trust us, they know. So when humans gain a little ground in the war against the buzzy little bloodsuckers, we want to share the joy.

Wesson Group/Tulane University

To know the enemy, scientists have to study the enemy, but there is a problem. “Many mosquito experiments still rely on human volunteers and animal subjects,” bioengineering graduate student Kevin Janson, said in a statement from Rice University. Most people don’t like being bitten by mosquitoes, so that kind of testing can be expensive.

Is there a way to automate the collection and processing of mosquito behavior data using inexpensive cameras and machine-learning software? We’re glad you asked, because Mr. Janson and the research team, which includes bioengineers from Rice and tropical medicine experts from Tulane University, have managed to eliminate the need for live volunteers by using patches of synthetic skin made with a 3D printer.

“Each patch of gelatin-like hydrogel comes complete with tiny passageways that can be filled with flowing blood” from a chicken, sheep, or cow, they explained, and proof-of-concept testing showed that mosquitoes would feed on hydrogels without any repellent and stay away from those treated with a repellent.

To conduct the feeding tests, the blood-infused hydrogels are placed in a clear plastic box that is surrounded by cameras.

A bunch of mosquitoes are then tossed in the box and the cameras record all their insect activities: how often they land at each location, how long they stay, whether or not they bite, how long they feed, etc. Humans don’t have to watch and don’t have to be food sources.

Humans don’t have to be food sources, and we just pictured the future of mosquito control. Imagine a dozen Arnold Schwarzenegger–style Terminators, covered in 3D-printed skin, walking through your neighborhood in the summer while wearing sweat-soaked, brightly colored clothing. The mosquitoes wouldn’t be able to stay away, but guess what? They’re feeding off robots with nonhuman skin and nonhuman blood, so we win. It’s good to have a cerebral cortex.
 

Getting medieval on brain surgery

Let’s get one thing clear: The so-called “Dark Ages” were not nearly as dark as they’re made out to be. For one thing, there’s a world beyond Western Europe. The Roman Empire didn’t collapse everywhere. But even in Western Europe, the centuries between the fall of Rome and the Renaissance were hardly lacking in cultural development.

Gleb Lucky/Unsplash

That said, we wouldn’t want to be in the position of the seventh-century noblewoman whose remains were recently uncovered in a Byzantine fortress in central Italy with multiple cross-shaped incisions in her skull. Yes, this unfortunate woman underwent at least two brain surgeries.

Then again, maybe not. Nothing like it had been discovered at the site, and while the markings – signs of a procedure called trepanation – can be surgical in nature, there are other explanations. For example, the Avar people practiced ritual trepanation during the same time period, but they were hundreds of miles away in the Carpathian mountains, and there was no evidence to support that a different form of ritualistic trepanation ever took place in Byzantine-era Italy.

The investigators then moved on to a form of judicial punishment called decalvatio, which involves mutilation by scalping. Look, the Dark Ages weren’t dark, but no one said they were fun. Anyway, this was discarded, since decalvatio was only meted out to soldiers who deserted the battlefield.

That brings us back to surgery. While one of the trepanations was fully engraved into her skull, indicating that the woman died soon after the surgery, she also bore indications of a healed trepanation. A 50% success rate isn’t terrible for our medieval surgeon. Sure, the Incas managed 80%, but even during the Civil War brain surgery only had a 50% success rate. And that’s the end of the story, nothing more to say about our medieval Italian woman.

Nope. Nothing at all.

Fine. While a surgical procedure was deemed most likely, the study investigators found no direct evidence of a medical condition. No trauma, no tumor, nothing. Just a couple of suggestions of “a systemic pathological condition,” they said. Okay, we swear, it really wasn’t that bad in the Middle [Editor’s note: Approximately 5,000 more words on medieval culture not included. This is a medical column, thank you very much.]

We’re gonna need a bigger meth lab

In case you’ve been living under a rock for the past 15 years, the TV show “Breaking Bad” details the spiraling rise and downfall of a high school chemistry teacher who, after developing a case of terminal lung cancer, starts producing methamphetamine to provide for his family in response to the steep cost of treatment for his cancer.

TheaDesign/Thinkstock

Meanwhile, here in 2023 in the real world, we have Paul Davis, a retired physician in Ohio, who’s being forced to choose between an expensive cancer treatment and bankrupting his family, since Medicare’s decided it doesn’t want to cover the cost. Hey, we’ve seen this one before!

A bit of backstory: In November 2019, Dr. Davis was diagnosed with uveal melanoma, a very rare type of cancer that affects eye tissue. The news got worse in 2022 when the cancer spread to his liver, a move which typically proves fatal within a year. However, in a stroke of great news, the Food and Drug Administration approved the drug Kimmtrak earlier that year, which could be used to treat his cancer. Not cure, of course, but it would give him more time.

His initial treatments with the drug went fine and were covered, but when he transferred his care from a hospital in Columbus to one closer to home, big problem. Medicare decided it didn’t like that hospital and abruptly cut off coverage, denying the local hospital’s claims. That leaves Dr. Davis on the hook for his cancer treatment, and it’s what you might call expensive. Expensive to the tune of $50,000.

A week.

Apparently the coding the local hospital submitted was wrong, indicating that Dr. Davis was receiving Kimmtrak for a type of cancer that the FDA hadn’t approved the drug for. So until the government bureaucracy works itself out, his treatment is on hold, leaving all his faith in Medicare working quickly to rectify its mistake. If it can rectify its mistake. We’re not hopeful.

And in case you were wondering, if Dr. Davis wanted to go full Walter White, the average street price of meth is about $20-$60 per gram, so to pay for his treatment, he’d need to make at least a kilogram of meth every week. That’s, uh, quite a lot of illegal drug, or what we here at the LOTME office would call a fun Saturday night.
 

When you give a mouse a movie

Researchers have been successfully testing Alzheimer drugs on mice for years, but none of the drugs has proved successful in humans. Recent work, however, might have found the missing link, and it’s a combination no one ever thought of before: mice and movies.

procesocreativo/PxHere

Turns out that Orson Welles’ 1958 film noir classic “Touch of Evil” tapped a part of the mouse brain that has been overlooked: the hippocampus, which is crucial for learning and memory. Previous researchers thought it was just used as a kind of GPS system, but that’s only partially true.

Not only did the mice choose to pay attention to the movie clip, but the hippocampus responded to the visual stimuli only when the rodents saw the scenes from the clip later in the order that they were presented and not in a scrambled order. These findings represent a “major paradigm shift” in studying mouse recall, Mayank Mehta, PhD, of the University of California, Los Angeles, said in a statement from the school.

This breakthrough could run parallel to Alzheimer’s patients struggling with similar defects. “Selective and episodic activation of the mouse hippocampus using a human movie opens up the possibility of directly testing human episodic memory disorders and therapies using mouse neurons, a major step forward,” said coauthor Chinmay Purandare, PhD, who is now at the University of California, San Francisco.

Who would have thought that a classic film would help advance Alzheimer research?
 

A less human way to study mosquitoes

We here at LOTME have a history with mosquitoes. We know they don’t like us, and they know that we don’t like them. Trust us, they know. So when humans gain a little ground in the war against the buzzy little bloodsuckers, we want to share the joy.

Wesson Group/Tulane University

To know the enemy, scientists have to study the enemy, but there is a problem. “Many mosquito experiments still rely on human volunteers and animal subjects,” bioengineering graduate student Kevin Janson, said in a statement from Rice University. Most people don’t like being bitten by mosquitoes, so that kind of testing can be expensive.

Is there a way to automate the collection and processing of mosquito behavior data using inexpensive cameras and machine-learning software? We’re glad you asked, because Mr. Janson and the research team, which includes bioengineers from Rice and tropical medicine experts from Tulane University, have managed to eliminate the need for live volunteers by using patches of synthetic skin made with a 3D printer.

“Each patch of gelatin-like hydrogel comes complete with tiny passageways that can be filled with flowing blood” from a chicken, sheep, or cow, they explained, and proof-of-concept testing showed that mosquitoes would feed on hydrogels without any repellent and stay away from those treated with a repellent.

To conduct the feeding tests, the blood-infused hydrogels are placed in a clear plastic box that is surrounded by cameras.

A bunch of mosquitoes are then tossed in the box and the cameras record all their insect activities: how often they land at each location, how long they stay, whether or not they bite, how long they feed, etc. Humans don’t have to watch and don’t have to be food sources.

Humans don’t have to be food sources, and we just pictured the future of mosquito control. Imagine a dozen Arnold Schwarzenegger–style Terminators, covered in 3D-printed skin, walking through your neighborhood in the summer while wearing sweat-soaked, brightly colored clothing. The mosquitoes wouldn’t be able to stay away, but guess what? They’re feeding off robots with nonhuman skin and nonhuman blood, so we win. It’s good to have a cerebral cortex.
 

Getting medieval on brain surgery

Let’s get one thing clear: The so-called “Dark Ages” were not nearly as dark as they’re made out to be. For one thing, there’s a world beyond Western Europe. The Roman Empire didn’t collapse everywhere. But even in Western Europe, the centuries between the fall of Rome and the Renaissance were hardly lacking in cultural development.

Gleb Lucky/Unsplash

That said, we wouldn’t want to be in the position of the seventh-century noblewoman whose remains were recently uncovered in a Byzantine fortress in central Italy with multiple cross-shaped incisions in her skull. Yes, this unfortunate woman underwent at least two brain surgeries.

Then again, maybe not. Nothing like it had been discovered at the site, and while the markings – signs of a procedure called trepanation – can be surgical in nature, there are other explanations. For example, the Avar people practiced ritual trepanation during the same time period, but they were hundreds of miles away in the Carpathian mountains, and there was no evidence to support that a different form of ritualistic trepanation ever took place in Byzantine-era Italy.

The investigators then moved on to a form of judicial punishment called decalvatio, which involves mutilation by scalping. Look, the Dark Ages weren’t dark, but no one said they were fun. Anyway, this was discarded, since decalvatio was only meted out to soldiers who deserted the battlefield.

That brings us back to surgery. While one of the trepanations was fully engraved into her skull, indicating that the woman died soon after the surgery, she also bore indications of a healed trepanation. A 50% success rate isn’t terrible for our medieval surgeon. Sure, the Incas managed 80%, but even during the Civil War brain surgery only had a 50% success rate. And that’s the end of the story, nothing more to say about our medieval Italian woman.

Nope. Nothing at all.

Fine. While a surgical procedure was deemed most likely, the study investigators found no direct evidence of a medical condition. No trauma, no tumor, nothing. Just a couple of suggestions of “a systemic pathological condition,” they said. Okay, we swear, it really wasn’t that bad in the Middle [Editor’s note: Approximately 5,000 more words on medieval culture not included. This is a medical column, thank you very much.]

We’re gonna need a bigger meth lab

In case you’ve been living under a rock for the past 15 years, the TV show “Breaking Bad” details the spiraling rise and downfall of a high school chemistry teacher who, after developing a case of terminal lung cancer, starts producing methamphetamine to provide for his family in response to the steep cost of treatment for his cancer.

TheaDesign/Thinkstock

Meanwhile, here in 2023 in the real world, we have Paul Davis, a retired physician in Ohio, who’s being forced to choose between an expensive cancer treatment and bankrupting his family, since Medicare’s decided it doesn’t want to cover the cost. Hey, we’ve seen this one before!

A bit of backstory: In November 2019, Dr. Davis was diagnosed with uveal melanoma, a very rare type of cancer that affects eye tissue. The news got worse in 2022 when the cancer spread to his liver, a move which typically proves fatal within a year. However, in a stroke of great news, the Food and Drug Administration approved the drug Kimmtrak earlier that year, which could be used to treat his cancer. Not cure, of course, but it would give him more time.

His initial treatments with the drug went fine and were covered, but when he transferred his care from a hospital in Columbus to one closer to home, big problem. Medicare decided it didn’t like that hospital and abruptly cut off coverage, denying the local hospital’s claims. That leaves Dr. Davis on the hook for his cancer treatment, and it’s what you might call expensive. Expensive to the tune of $50,000.

A week.

Apparently the coding the local hospital submitted was wrong, indicating that Dr. Davis was receiving Kimmtrak for a type of cancer that the FDA hadn’t approved the drug for. So until the government bureaucracy works itself out, his treatment is on hold, leaving all his faith in Medicare working quickly to rectify its mistake. If it can rectify its mistake. We’re not hopeful.

And in case you were wondering, if Dr. Davis wanted to go full Walter White, the average street price of meth is about $20-$60 per gram, so to pay for his treatment, he’d need to make at least a kilogram of meth every week. That’s, uh, quite a lot of illegal drug, or what we here at the LOTME office would call a fun Saturday night.
 

When you give a mouse a movie

Researchers have been successfully testing Alzheimer drugs on mice for years, but none of the drugs has proved successful in humans. Recent work, however, might have found the missing link, and it’s a combination no one ever thought of before: mice and movies.

procesocreativo/PxHere

Turns out that Orson Welles’ 1958 film noir classic “Touch of Evil” tapped a part of the mouse brain that has been overlooked: the hippocampus, which is crucial for learning and memory. Previous researchers thought it was just used as a kind of GPS system, but that’s only partially true.

Not only did the mice choose to pay attention to the movie clip, but the hippocampus responded to the visual stimuli only when the rodents saw the scenes from the clip later in the order that they were presented and not in a scrambled order. These findings represent a “major paradigm shift” in studying mouse recall, Mayank Mehta, PhD, of the University of California, Los Angeles, said in a statement from the school.

This breakthrough could run parallel to Alzheimer’s patients struggling with similar defects. “Selective and episodic activation of the mouse hippocampus using a human movie opens up the possibility of directly testing human episodic memory disorders and therapies using mouse neurons, a major step forward,” said coauthor Chinmay Purandare, PhD, who is now at the University of California, San Francisco.

Who would have thought that a classic film would help advance Alzheimer research?
 

A less human way to study mosquitoes

We here at LOTME have a history with mosquitoes. We know they don’t like us, and they know that we don’t like them. Trust us, they know. So when humans gain a little ground in the war against the buzzy little bloodsuckers, we want to share the joy.

Wesson Group/Tulane University

To know the enemy, scientists have to study the enemy, but there is a problem. “Many mosquito experiments still rely on human volunteers and animal subjects,” bioengineering graduate student Kevin Janson, said in a statement from Rice University. Most people don’t like being bitten by mosquitoes, so that kind of testing can be expensive.

Is there a way to automate the collection and processing of mosquito behavior data using inexpensive cameras and machine-learning software? We’re glad you asked, because Mr. Janson and the research team, which includes bioengineers from Rice and tropical medicine experts from Tulane University, have managed to eliminate the need for live volunteers by using patches of synthetic skin made with a 3D printer.

“Each patch of gelatin-like hydrogel comes complete with tiny passageways that can be filled with flowing blood” from a chicken, sheep, or cow, they explained, and proof-of-concept testing showed that mosquitoes would feed on hydrogels without any repellent and stay away from those treated with a repellent.

To conduct the feeding tests, the blood-infused hydrogels are placed in a clear plastic box that is surrounded by cameras.

A bunch of mosquitoes are then tossed in the box and the cameras record all their insect activities: how often they land at each location, how long they stay, whether or not they bite, how long they feed, etc. Humans don’t have to watch and don’t have to be food sources.

Humans don’t have to be food sources, and we just pictured the future of mosquito control. Imagine a dozen Arnold Schwarzenegger–style Terminators, covered in 3D-printed skin, walking through your neighborhood in the summer while wearing sweat-soaked, brightly colored clothing. The mosquitoes wouldn’t be able to stay away, but guess what? They’re feeding off robots with nonhuman skin and nonhuman blood, so we win. It’s good to have a cerebral cortex.
 

Getting medieval on brain surgery

Let’s get one thing clear: The so-called “Dark Ages” were not nearly as dark as they’re made out to be. For one thing, there’s a world beyond Western Europe. The Roman Empire didn’t collapse everywhere. But even in Western Europe, the centuries between the fall of Rome and the Renaissance were hardly lacking in cultural development.

Gleb Lucky/Unsplash

That said, we wouldn’t want to be in the position of the seventh-century noblewoman whose remains were recently uncovered in a Byzantine fortress in central Italy with multiple cross-shaped incisions in her skull. Yes, this unfortunate woman underwent at least two brain surgeries.

Then again, maybe not. Nothing like it had been discovered at the site, and while the markings – signs of a procedure called trepanation – can be surgical in nature, there are other explanations. For example, the Avar people practiced ritual trepanation during the same time period, but they were hundreds of miles away in the Carpathian mountains, and there was no evidence to support that a different form of ritualistic trepanation ever took place in Byzantine-era Italy.

The investigators then moved on to a form of judicial punishment called decalvatio, which involves mutilation by scalping. Look, the Dark Ages weren’t dark, but no one said they were fun. Anyway, this was discarded, since decalvatio was only meted out to soldiers who deserted the battlefield.

That brings us back to surgery. While one of the trepanations was fully engraved into her skull, indicating that the woman died soon after the surgery, she also bore indications of a healed trepanation. A 50% success rate isn’t terrible for our medieval surgeon. Sure, the Incas managed 80%, but even during the Civil War brain surgery only had a 50% success rate. And that’s the end of the story, nothing more to say about our medieval Italian woman.

Nope. Nothing at all.

Fine. While a surgical procedure was deemed most likely, the study investigators found no direct evidence of a medical condition. No trauma, no tumor, nothing. Just a couple of suggestions of “a systemic pathological condition,” they said. Okay, we swear, it really wasn’t that bad in the Middle [Editor’s note: Approximately 5,000 more words on medieval culture not included. This is a medical column, thank you very much.]

Doctors are more likely to miss appendicitis in patients who are Black, research shows.

This phenomenon, first described in children, occurs in adults as well, according to a study published in JAMA Surgery.

Some hospitals fare better than others: Those with more diverse patient populations were less likely to have missed the diagnosis, the researchers found.

“We don’t think the amount of melanin in your skin predicts how you present with appendicitis,” said Jonathan Carter, MD, professor of surgery at the University of California, San Francisco. “There’s no biological explanation,” Dr. Carter, who wrote an invited commentary on the research, said in an interview. “It’s really what’s going on in the social environment of those emergency rooms.”

For the study, Anne Stey, MD, assistant professor of surgery at Northwestern University in Chicago and her colleagues analyzed data from more than 80,000 men and women in four states – Florida, Maryland, New York, and Wisconsin – who underwent appendectomy in 2016-2017.

They identified those who had been seen for abdominal complaints at a hospital in the week before surgery but did not receive a diagnosis of appendicitis at that time, indicating a missed opportunity to intervene sooner.

Among Black patients, the proportion who had experienced this type of delay was 3.6%, whereas for White patients, it was 2.5%. For Hispanic patients, the share was 2.4%, while for Asian or Pacific Islander patients, the figure was 1.5%.

An analysis that controlled for patient and hospital variables found that among non-Hispanic Black patients, the rate of delayed diagnosis was 1.41 times higher than for non-Hispanic White patients (95% confidence interval, 1.21-1.63).

Other patient factors associated with delayed diagnosis included female sex, comorbidities, and living in a low-income zip code.

A key factor was where patients sought care. A delayed diagnosis of appendicitis was 3.51 times more likely for patients who went to hospitals where most patients are insured by Medicaid. Prior research has shown that “safety-net hospitals have fewer resources and may provide lower-quality care than hospitals with a larger private payer population,” Dr. Stey’s group writes.

On the other hand, going to a hospital with a more diverse patient population reduced the odds of a delayed diagnosis.

“Patients presenting to hospitals with a greater than 50% Black and Hispanic population were 0.73 (95% CI, 0.59-0.91) times less likely to have a delayed diagnosis, compared with patients presenting to hospitals with a less than 25% Black and Hispanic population,” the researchers report.

In the 30 days after discharge following appendectomy, Black patients returned to the hospital at a higher rate than White patients did (17.5% vs. 11.4%), indicating worse outcomes.

“Delayed diagnosis may account for some of the racial and ethnic disparities observed in outcomes after appendicitis,” according to the authors.

“It may be hospitals that are more used to serving racial-ethnic minority patients are better at diagnosing them, because they’re more culturally informed and have a better understanding of these patients,” Dr. Stey said in a news release about their findings.
 

Great masquerader

Diagnosing appendicitis can be challenging, Dr. Carter said. The early signs can be subtle, and the condition is sometimes called the great masquerader. It is not uncommon for patients to be diagnosed with gastroenteritis or pain associated with their menstrual period, for example, and sent home.

Scoring systems based on patients’ symptoms and liberal use of imaging have improved detection of appendicitis, but “no physician or health care system is perfect in the diagnosis,” he said.

The increased odds of delayed diagnosis for Black patients remained when the researchers focused on healthier patients who had fewer comorbidities, and it also held when they considered patients with private insurance in high-income areas, Dr. Carter noted.

“Once again, with this study we see the association of structural and systematic racism with access to health care, especially for Black patients, in emergency departments and hospitals,” he wrote. “We must redouble our efforts to become anti-racist in ourselves, our institutions, and our profession.”
 

‘Our health care system itself’

Elizabeth Garner, MD, MPH, a pharmaceutical executive who was not involved in the study, commented on Twitter that the study points to an underlying issue that has existed in medicine “for quite some time.”

“Minority populations are not taken as seriously as their white counterparts,” she wrote. “This needs to change.”

Measures of hospital quality need to be tied to health equity, according to Mofya Diallo, MD, MPH, of the department of anesthesiology at the Children’s Hospital Los Angeles and the University of Southern California, Los Angeles.

“Top hospitals should take pride in outcomes that do not vary based on race, income or literacy,” she tweeted in response to the study.

To better understand possible reasons for delayed diagnosis, future researchers could assess whether patients who are Black are less likely to receive a surgical consultation, imaging studies, or lab work, Dr. Carter told this news organization. He pointed to a recent analysis of patients insured by Medicare that found that Black patients were less likely than White patients to receive a surgical consultation after they were admitted with colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, or upper gastrointestinal diagnoses.

While social determinants of health, such as income, education, housing, early childhood development, employment, and social inclusion, may account for a substantial portion of health outcomes, “Our health care system itself can be viewed as another social determinant of health,” Dr. Carter wrote. “Insurance coverage, health care professional availability, health care professional linguistic and cultural competency, and quality of care all have an effect on health outcomes.”

Dr. Stey was supported by grants from the American College of Surgeons and the National Institutes of Health.

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

Doctors are more likely to miss appendicitis in patients who are Black, research shows.

This phenomenon, first described in children, occurs in adults as well, according to a study published in JAMA Surgery.

Some hospitals fare better than others: Those with more diverse patient populations were less likely to have missed the diagnosis, the researchers found.

“We don’t think the amount of melanin in your skin predicts how you present with appendicitis,” said Jonathan Carter, MD, professor of surgery at the University of California, San Francisco. “There’s no biological explanation,” Dr. Carter, who wrote an invited commentary on the research, said in an interview. “It’s really what’s going on in the social environment of those emergency rooms.”

For the study, Anne Stey, MD, assistant professor of surgery at Northwestern University in Chicago and her colleagues analyzed data from more than 80,000 men and women in four states – Florida, Maryland, New York, and Wisconsin – who underwent appendectomy in 2016-2017.

They identified those who had been seen for abdominal complaints at a hospital in the week before surgery but did not receive a diagnosis of appendicitis at that time, indicating a missed opportunity to intervene sooner.

Among Black patients, the proportion who had experienced this type of delay was 3.6%, whereas for White patients, it was 2.5%. For Hispanic patients, the share was 2.4%, while for Asian or Pacific Islander patients, the figure was 1.5%.

An analysis that controlled for patient and hospital variables found that among non-Hispanic Black patients, the rate of delayed diagnosis was 1.41 times higher than for non-Hispanic White patients (95% confidence interval, 1.21-1.63).

Other patient factors associated with delayed diagnosis included female sex, comorbidities, and living in a low-income zip code.

A key factor was where patients sought care. A delayed diagnosis of appendicitis was 3.51 times more likely for patients who went to hospitals where most patients are insured by Medicaid. Prior research has shown that “safety-net hospitals have fewer resources and may provide lower-quality care than hospitals with a larger private payer population,” Dr. Stey’s group writes.

On the other hand, going to a hospital with a more diverse patient population reduced the odds of a delayed diagnosis.

“Patients presenting to hospitals with a greater than 50% Black and Hispanic population were 0.73 (95% CI, 0.59-0.91) times less likely to have a delayed diagnosis, compared with patients presenting to hospitals with a less than 25% Black and Hispanic population,” the researchers report.

In the 30 days after discharge following appendectomy, Black patients returned to the hospital at a higher rate than White patients did (17.5% vs. 11.4%), indicating worse outcomes.

“Delayed diagnosis may account for some of the racial and ethnic disparities observed in outcomes after appendicitis,” according to the authors.

“It may be hospitals that are more used to serving racial-ethnic minority patients are better at diagnosing them, because they’re more culturally informed and have a better understanding of these patients,” Dr. Stey said in a news release about their findings.
 

Great masquerader

Diagnosing appendicitis can be challenging, Dr. Carter said. The early signs can be subtle, and the condition is sometimes called the great masquerader. It is not uncommon for patients to be diagnosed with gastroenteritis or pain associated with their menstrual period, for example, and sent home.

Scoring systems based on patients’ symptoms and liberal use of imaging have improved detection of appendicitis, but “no physician or health care system is perfect in the diagnosis,” he said.

The increased odds of delayed diagnosis for Black patients remained when the researchers focused on healthier patients who had fewer comorbidities, and it also held when they considered patients with private insurance in high-income areas, Dr. Carter noted.

“Once again, with this study we see the association of structural and systematic racism with access to health care, especially for Black patients, in emergency departments and hospitals,” he wrote. “We must redouble our efforts to become anti-racist in ourselves, our institutions, and our profession.”
 

‘Our health care system itself’

Elizabeth Garner, MD, MPH, a pharmaceutical executive who was not involved in the study, commented on Twitter that the study points to an underlying issue that has existed in medicine “for quite some time.”

“Minority populations are not taken as seriously as their white counterparts,” she wrote. “This needs to change.”

Measures of hospital quality need to be tied to health equity, according to Mofya Diallo, MD, MPH, of the department of anesthesiology at the Children’s Hospital Los Angeles and the University of Southern California, Los Angeles.

“Top hospitals should take pride in outcomes that do not vary based on race, income or literacy,” she tweeted in response to the study.

To better understand possible reasons for delayed diagnosis, future researchers could assess whether patients who are Black are less likely to receive a surgical consultation, imaging studies, or lab work, Dr. Carter told this news organization. He pointed to a recent analysis of patients insured by Medicare that found that Black patients were less likely than White patients to receive a surgical consultation after they were admitted with colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, or upper gastrointestinal diagnoses.

While social determinants of health, such as income, education, housing, early childhood development, employment, and social inclusion, may account for a substantial portion of health outcomes, “Our health care system itself can be viewed as another social determinant of health,” Dr. Carter wrote. “Insurance coverage, health care professional availability, health care professional linguistic and cultural competency, and quality of care all have an effect on health outcomes.”

Dr. Stey was supported by grants from the American College of Surgeons and the National Institutes of Health.

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

Doctors are more likely to miss appendicitis in patients who are Black, research shows.

This phenomenon, first described in children, occurs in adults as well, according to a study published in JAMA Surgery.

Some hospitals fare better than others: Those with more diverse patient populations were less likely to have missed the diagnosis, the researchers found.

“We don’t think the amount of melanin in your skin predicts how you present with appendicitis,” said Jonathan Carter, MD, professor of surgery at the University of California, San Francisco. “There’s no biological explanation,” Dr. Carter, who wrote an invited commentary on the research, said in an interview. “It’s really what’s going on in the social environment of those emergency rooms.”

For the study, Anne Stey, MD, assistant professor of surgery at Northwestern University in Chicago and her colleagues analyzed data from more than 80,000 men and women in four states – Florida, Maryland, New York, and Wisconsin – who underwent appendectomy in 2016-2017.

They identified those who had been seen for abdominal complaints at a hospital in the week before surgery but did not receive a diagnosis of appendicitis at that time, indicating a missed opportunity to intervene sooner.

Among Black patients, the proportion who had experienced this type of delay was 3.6%, whereas for White patients, it was 2.5%. For Hispanic patients, the share was 2.4%, while for Asian or Pacific Islander patients, the figure was 1.5%.

An analysis that controlled for patient and hospital variables found that among non-Hispanic Black patients, the rate of delayed diagnosis was 1.41 times higher than for non-Hispanic White patients (95% confidence interval, 1.21-1.63).

Other patient factors associated with delayed diagnosis included female sex, comorbidities, and living in a low-income zip code.

A key factor was where patients sought care. A delayed diagnosis of appendicitis was 3.51 times more likely for patients who went to hospitals where most patients are insured by Medicaid. Prior research has shown that “safety-net hospitals have fewer resources and may provide lower-quality care than hospitals with a larger private payer population,” Dr. Stey’s group writes.

On the other hand, going to a hospital with a more diverse patient population reduced the odds of a delayed diagnosis.

“Patients presenting to hospitals with a greater than 50% Black and Hispanic population were 0.73 (95% CI, 0.59-0.91) times less likely to have a delayed diagnosis, compared with patients presenting to hospitals with a less than 25% Black and Hispanic population,” the researchers report.

In the 30 days after discharge following appendectomy, Black patients returned to the hospital at a higher rate than White patients did (17.5% vs. 11.4%), indicating worse outcomes.

“Delayed diagnosis may account for some of the racial and ethnic disparities observed in outcomes after appendicitis,” according to the authors.

“It may be hospitals that are more used to serving racial-ethnic minority patients are better at diagnosing them, because they’re more culturally informed and have a better understanding of these patients,” Dr. Stey said in a news release about their findings.
 

Great masquerader

Diagnosing appendicitis can be challenging, Dr. Carter said. The early signs can be subtle, and the condition is sometimes called the great masquerader. It is not uncommon for patients to be diagnosed with gastroenteritis or pain associated with their menstrual period, for example, and sent home.

Scoring systems based on patients’ symptoms and liberal use of imaging have improved detection of appendicitis, but “no physician or health care system is perfect in the diagnosis,” he said.

The increased odds of delayed diagnosis for Black patients remained when the researchers focused on healthier patients who had fewer comorbidities, and it also held when they considered patients with private insurance in high-income areas, Dr. Carter noted.

“Once again, with this study we see the association of structural and systematic racism with access to health care, especially for Black patients, in emergency departments and hospitals,” he wrote. “We must redouble our efforts to become anti-racist in ourselves, our institutions, and our profession.”
 

‘Our health care system itself’

Elizabeth Garner, MD, MPH, a pharmaceutical executive who was not involved in the study, commented on Twitter that the study points to an underlying issue that has existed in medicine “for quite some time.”

“Minority populations are not taken as seriously as their white counterparts,” she wrote. “This needs to change.”

Measures of hospital quality need to be tied to health equity, according to Mofya Diallo, MD, MPH, of the department of anesthesiology at the Children’s Hospital Los Angeles and the University of Southern California, Los Angeles.

“Top hospitals should take pride in outcomes that do not vary based on race, income or literacy,” she tweeted in response to the study.

To better understand possible reasons for delayed diagnosis, future researchers could assess whether patients who are Black are less likely to receive a surgical consultation, imaging studies, or lab work, Dr. Carter told this news organization. He pointed to a recent analysis of patients insured by Medicare that found that Black patients were less likely than White patients to receive a surgical consultation after they were admitted with colorectal, general abdominal, hepatopancreatobiliary, intestinal obstruction, or upper gastrointestinal diagnoses.

While social determinants of health, such as income, education, housing, early childhood development, employment, and social inclusion, may account for a substantial portion of health outcomes, “Our health care system itself can be viewed as another social determinant of health,” Dr. Carter wrote. “Insurance coverage, health care professional availability, health care professional linguistic and cultural competency, and quality of care all have an effect on health outcomes.”

Dr. Stey was supported by grants from the American College of Surgeons and the National Institutes of Health.

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

An oncologist who says she was fired for whistleblower retaliation and gender discrimination has now filed a lawsuit against her former employer.

Anne Grand’Maison, MD, was employed at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., for 5 years and was the first medical oncologist specifically trained in sarcoma to join the center since it was founded more than 130 years ago.

The lawsuit, filed on Jan. 31, alleges that she was pushed out of her job after raising numerous concerns about egregious medical misconduct and lack of patient safety at the facility.

Roswell Park Cancer Center “denies these unfounded claims, and will vigorously defend itself in this matter,” the organization said in a statement issued to this news organization.

The 75-page complaint alleges that Dr. Grand’Maison observed unacceptable conduct and treatment of patients, including sarcoma pathology reports replete with diagnostic errors, physicians who were not well educated in the latest sarcoma research, and senior doctors refusing to seek out second opinions even in difficult cases.

All of these issues put patient safety and lives at serious risk, according to the lawsuit, and Dr. Grand’Maison raised her concerns internally and attempted to create the necessary changes.

Of specific concern to Dr. Grand’Maison was the competence of Carl Morrison, MD, DVM, Roswell Park’s lead sarcoma pathologist and chair of pathology, whom she had questioned on many occasions and voiced concerns about to other senior staff. But once she made it known that she had gathered up medical records to prove that he had made numerous specific misdiagnoses that led to mistreatments, Dr. Grand’Maison was forced out of her job and the hospital, she said.

“Roswell failed the cancer patients who entrusted their lives to the hospital by ignoring risks to their safety,” Dr. Grand’Maison said in an interview. “The heart of my practice as an oncologist is the well-being of my patients and that is why I could not stay silent.

“I hope that by coming forward, Roswell will be held accountable for putting lives at risk,” she said.
 

Not up to date with best practices

Before joining Roswell, Dr. Grand’Maison had worked at the University of Texas MD Anderson Cancer Center, which is the top cancer center in the nation, noted David E. Gottlieb, a partner at Wigdor, the law firm that is representing her.

MD Anderson has set the standard for sarcoma care, as they treat the highest volume of sarcoma cases of any hospital in North America and they have the best survival outcomes for sarcoma patients, he said in an interview.

“She was bringing this knowledge and background to Roswell Park,” Mr. Gottlieb said. “She felt that Dr. Morrison was not up to date with best practices as far as diagnosing and treating sarcoma, and she raised numerous issues.

“He was not open to being critiqued and even rejected her request to send something out for a second opinion,” Mr. Gottlieb said. “Second opinions are routine in medicine, and it’s the standard of care. We are dealing with a person’s life and it’s not a personal attack – you could be wrong, and getting another opinion can save a patient’s life.”

But Dr. Morrison has been at Roswell Park for many years, is a good friend of Roswell’s president and CEO Candace Johnson, PhD, and is part of the “old guard,” and “really at the top of the organization,” Mr. Gottlieb said  “Whereas Dr. Grand’Maison was relatively new, and her opinions were not popular.”

The complaint was filed against defendants Roswell Park Comprehensive Care Center; Health Research Inc. Roswell Park Division; Candace Johnson, PhD; Carl Morrison, MD, DVM; Renier Brentjens, MD, PhD, deputy director and chair of medicine; and two other senior physicians.
 

Denial of ‘unfounded claims’

In its statement, Roswell Park pointed out that it is one of few centers in the nation recognized by the Sarcoma Alliance as a hospital with specialized expertise and resources for patients with sarcoma. “Our physician experts not only adhere strictly to national best practices in the diagnosis and care of patients with sarcoma, they determine and disseminate the standards of appropriate medical care as lead authors of national guidelines,” the center stated.

“The facts demonstrate that Roswell Park is a richly diverse and inclusive organization committed to optimizing cancer care by incorporating the expertise of teams of specialists from many subspecialties and disciplines,” according to the statement.
 

Resistance and male egos

Dr. Grand’Maison has been a licensed physician for more than 30 years, and received her MD in 1988 after graduating from Sherbrooke University in Quebec. Over the next few decades she worked in clinical medicine and research, both in Canada and the United States. In 2014, she became certified in medical oncology and then secured a clinical and research fellowship focusing on sarcoma at MD Anderson.

Two years later, after completing her fellowship, she accepted a full-time position as an assistant professor of oncology in the department of medical oncology’s sarcoma division at Roswell Park. She became the first medical oncologist with a subspecialty in sarcoma, and also brought with her the advanced techniques and aggressive treatment that had been pioneered by MD Anderson, and which had never been used at Roswell Park, according to the complaint.

However, Dr. Grand’Maison said that she began to encounter some resistance from those more familiar with Roswell’s previous standard operating procedures. For example, her practice of seeing patients on days when chemotherapy was administered was viewed by some of the advanced practice clinicians as a lack of confidence in their abilities.

According to the complaint, Dr. Grand’Maison found the sarcoma tumor board at Roswell to be “male-dominated, ego-driven, fraught with defensiveness, and rife with a lack of collegiality almost from the very beginning,” which was very different from her experience at MD Anderson.

Less than 6 months after joining Roswell, she said that Dr. Morrison began treating her in a condescending manner at the tumor board meetings when she asked him questions pertaining to a diagnosis. She viewed his “physically intimidating and aggressive conduct toward her as sexist, and it was a pattern of conduct that would persist in the years that followed.” Dr. Grand’Maison observed that Dr. Morrison never behaved that way toward the men when discussing a case.

Over time, Dr. Grand’Maison made numerous and near endless efforts to raise her concerns about patient safety and gender discrimination at Roswell Park and had reached out to her supervisor and to others in upper management, the complaint alleges. All of this appeared to fall on completely deaf ears as hospital “politics” and doctor egos took precedence. Dr. Morrison continued to try to intimidate her into “silence” and block her attempts to refine diagnoses to ensure proper treatment, and several other senior physicians enabled his behavior and ignored the risk it posed to patient safety, the complaint alleges.  

“While she raised complaints about gender discrimination, the crux of her complaint was patient safety,” Mr. Gottlieb emphasized.

Another issue was that Dr. Grand’Maison never received the proper clinical support she repeatedly requested and that was urgently needed. Thus, her patients faced other elevated safety risks as a result of the underresourced sarcoma clinic, she said.
 

Fired or resigned?

Dr. Grand’Maison left Roswell Park Cancer center last May, and has not worked since.

Although Dr. Grand’Maison stated that she was fired in retaliation for raising serious concerns, Roswell Park insists that she voluntarily resigned. Dr. Grand’Maison acknowledged that she wrote an email in January 2022 to the clinical practice plan coordinator in which she mentioned that her husband was planning to relocate back to Canada and that her last date at Roswell Park would be May 1, 2022. The coordinator never responded to that email. In the interim, her husband, also a physician with privileges at Roswell Park, made it known that he was not moving to Canada.

Dr. Grand’Maison said that, as she had not resigned, and everyone knew her husband wasn’t moving, she did not follow up on that January 2022 email, and then forgot about it.

“That email was used as the basis to force her out,”said her lawyer, Mr. Gottlieb. “The day after she put together a summary and extensively documented serious patient safety concerns, she got an email that her resignation had been accepted.”

None of the standard protocols for resignation had been completed, either by human resources or by her supervisors, Mr. Gottlieb contended. “The law says that they can’t take adverse action against her for filing a complaint, so they fired her under the guise of a resignation,” he said.

Roswell Park refused to rescind Dr. Grand’Maison’s resignation, despite multiple attempts on her part. She even contacted the CEO and stated that her January 2022 email was being used a pretext to push her out in retaliation, but she received no response, only that the matter had been referred to someone else.

“I am speaking out because time and again female doctors are unable to deliver on the promise of their medical training because of discrimination,” said Dr. Grand’Maison. “Roswell dismissed my expertise and diminished my value. While I worry that coming forward may affect my career, I am taking that risk to make the path easier for the women who will come behind me.”

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

An oncologist who says she was fired for whistleblower retaliation and gender discrimination has now filed a lawsuit against her former employer.

Anne Grand’Maison, MD, was employed at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., for 5 years and was the first medical oncologist specifically trained in sarcoma to join the center since it was founded more than 130 years ago.

The lawsuit, filed on Jan. 31, alleges that she was pushed out of her job after raising numerous concerns about egregious medical misconduct and lack of patient safety at the facility.

Roswell Park Cancer Center “denies these unfounded claims, and will vigorously defend itself in this matter,” the organization said in a statement issued to this news organization.

The 75-page complaint alleges that Dr. Grand’Maison observed unacceptable conduct and treatment of patients, including sarcoma pathology reports replete with diagnostic errors, physicians who were not well educated in the latest sarcoma research, and senior doctors refusing to seek out second opinions even in difficult cases.

All of these issues put patient safety and lives at serious risk, according to the lawsuit, and Dr. Grand’Maison raised her concerns internally and attempted to create the necessary changes.

Of specific concern to Dr. Grand’Maison was the competence of Carl Morrison, MD, DVM, Roswell Park’s lead sarcoma pathologist and chair of pathology, whom she had questioned on many occasions and voiced concerns about to other senior staff. But once she made it known that she had gathered up medical records to prove that he had made numerous specific misdiagnoses that led to mistreatments, Dr. Grand’Maison was forced out of her job and the hospital, she said.

“Roswell failed the cancer patients who entrusted their lives to the hospital by ignoring risks to their safety,” Dr. Grand’Maison said in an interview. “The heart of my practice as an oncologist is the well-being of my patients and that is why I could not stay silent.

“I hope that by coming forward, Roswell will be held accountable for putting lives at risk,” she said.
 

Not up to date with best practices

Before joining Roswell, Dr. Grand’Maison had worked at the University of Texas MD Anderson Cancer Center, which is the top cancer center in the nation, noted David E. Gottlieb, a partner at Wigdor, the law firm that is representing her.

MD Anderson has set the standard for sarcoma care, as they treat the highest volume of sarcoma cases of any hospital in North America and they have the best survival outcomes for sarcoma patients, he said in an interview.

“She was bringing this knowledge and background to Roswell Park,” Mr. Gottlieb said. “She felt that Dr. Morrison was not up to date with best practices as far as diagnosing and treating sarcoma, and she raised numerous issues.

“He was not open to being critiqued and even rejected her request to send something out for a second opinion,” Mr. Gottlieb said. “Second opinions are routine in medicine, and it’s the standard of care. We are dealing with a person’s life and it’s not a personal attack – you could be wrong, and getting another opinion can save a patient’s life.”

But Dr. Morrison has been at Roswell Park for many years, is a good friend of Roswell’s president and CEO Candace Johnson, PhD, and is part of the “old guard,” and “really at the top of the organization,” Mr. Gottlieb said  “Whereas Dr. Grand’Maison was relatively new, and her opinions were not popular.”

The complaint was filed against defendants Roswell Park Comprehensive Care Center; Health Research Inc. Roswell Park Division; Candace Johnson, PhD; Carl Morrison, MD, DVM; Renier Brentjens, MD, PhD, deputy director and chair of medicine; and two other senior physicians.
 

Denial of ‘unfounded claims’

In its statement, Roswell Park pointed out that it is one of few centers in the nation recognized by the Sarcoma Alliance as a hospital with specialized expertise and resources for patients with sarcoma. “Our physician experts not only adhere strictly to national best practices in the diagnosis and care of patients with sarcoma, they determine and disseminate the standards of appropriate medical care as lead authors of national guidelines,” the center stated.

“The facts demonstrate that Roswell Park is a richly diverse and inclusive organization committed to optimizing cancer care by incorporating the expertise of teams of specialists from many subspecialties and disciplines,” according to the statement.
 

Resistance and male egos

Dr. Grand’Maison has been a licensed physician for more than 30 years, and received her MD in 1988 after graduating from Sherbrooke University in Quebec. Over the next few decades she worked in clinical medicine and research, both in Canada and the United States. In 2014, she became certified in medical oncology and then secured a clinical and research fellowship focusing on sarcoma at MD Anderson.

Two years later, after completing her fellowship, she accepted a full-time position as an assistant professor of oncology in the department of medical oncology’s sarcoma division at Roswell Park. She became the first medical oncologist with a subspecialty in sarcoma, and also brought with her the advanced techniques and aggressive treatment that had been pioneered by MD Anderson, and which had never been used at Roswell Park, according to the complaint.

However, Dr. Grand’Maison said that she began to encounter some resistance from those more familiar with Roswell’s previous standard operating procedures. For example, her practice of seeing patients on days when chemotherapy was administered was viewed by some of the advanced practice clinicians as a lack of confidence in their abilities.

According to the complaint, Dr. Grand’Maison found the sarcoma tumor board at Roswell to be “male-dominated, ego-driven, fraught with defensiveness, and rife with a lack of collegiality almost from the very beginning,” which was very different from her experience at MD Anderson.

Less than 6 months after joining Roswell, she said that Dr. Morrison began treating her in a condescending manner at the tumor board meetings when she asked him questions pertaining to a diagnosis. She viewed his “physically intimidating and aggressive conduct toward her as sexist, and it was a pattern of conduct that would persist in the years that followed.” Dr. Grand’Maison observed that Dr. Morrison never behaved that way toward the men when discussing a case.

Over time, Dr. Grand’Maison made numerous and near endless efforts to raise her concerns about patient safety and gender discrimination at Roswell Park and had reached out to her supervisor and to others in upper management, the complaint alleges. All of this appeared to fall on completely deaf ears as hospital “politics” and doctor egos took precedence. Dr. Morrison continued to try to intimidate her into “silence” and block her attempts to refine diagnoses to ensure proper treatment, and several other senior physicians enabled his behavior and ignored the risk it posed to patient safety, the complaint alleges.  

“While she raised complaints about gender discrimination, the crux of her complaint was patient safety,” Mr. Gottlieb emphasized.

Another issue was that Dr. Grand’Maison never received the proper clinical support she repeatedly requested and that was urgently needed. Thus, her patients faced other elevated safety risks as a result of the underresourced sarcoma clinic, she said.
 

Fired or resigned?

Dr. Grand’Maison left Roswell Park Cancer center last May, and has not worked since.

Although Dr. Grand’Maison stated that she was fired in retaliation for raising serious concerns, Roswell Park insists that she voluntarily resigned. Dr. Grand’Maison acknowledged that she wrote an email in January 2022 to the clinical practice plan coordinator in which she mentioned that her husband was planning to relocate back to Canada and that her last date at Roswell Park would be May 1, 2022. The coordinator never responded to that email. In the interim, her husband, also a physician with privileges at Roswell Park, made it known that he was not moving to Canada.

Dr. Grand’Maison said that, as she had not resigned, and everyone knew her husband wasn’t moving, she did not follow up on that January 2022 email, and then forgot about it.

“That email was used as the basis to force her out,”said her lawyer, Mr. Gottlieb. “The day after she put together a summary and extensively documented serious patient safety concerns, she got an email that her resignation had been accepted.”

None of the standard protocols for resignation had been completed, either by human resources or by her supervisors, Mr. Gottlieb contended. “The law says that they can’t take adverse action against her for filing a complaint, so they fired her under the guise of a resignation,” he said.

Roswell Park refused to rescind Dr. Grand’Maison’s resignation, despite multiple attempts on her part. She even contacted the CEO and stated that her January 2022 email was being used a pretext to push her out in retaliation, but she received no response, only that the matter had been referred to someone else.

“I am speaking out because time and again female doctors are unable to deliver on the promise of their medical training because of discrimination,” said Dr. Grand’Maison. “Roswell dismissed my expertise and diminished my value. While I worry that coming forward may affect my career, I am taking that risk to make the path easier for the women who will come behind me.”

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

An oncologist who says she was fired for whistleblower retaliation and gender discrimination has now filed a lawsuit against her former employer.

Anne Grand’Maison, MD, was employed at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., for 5 years and was the first medical oncologist specifically trained in sarcoma to join the center since it was founded more than 130 years ago.

The lawsuit, filed on Jan. 31, alleges that she was pushed out of her job after raising numerous concerns about egregious medical misconduct and lack of patient safety at the facility.

Roswell Park Cancer Center “denies these unfounded claims, and will vigorously defend itself in this matter,” the organization said in a statement issued to this news organization.

The 75-page complaint alleges that Dr. Grand’Maison observed unacceptable conduct and treatment of patients, including sarcoma pathology reports replete with diagnostic errors, physicians who were not well educated in the latest sarcoma research, and senior doctors refusing to seek out second opinions even in difficult cases.

All of these issues put patient safety and lives at serious risk, according to the lawsuit, and Dr. Grand’Maison raised her concerns internally and attempted to create the necessary changes.

Of specific concern to Dr. Grand’Maison was the competence of Carl Morrison, MD, DVM, Roswell Park’s lead sarcoma pathologist and chair of pathology, whom she had questioned on many occasions and voiced concerns about to other senior staff. But once she made it known that she had gathered up medical records to prove that he had made numerous specific misdiagnoses that led to mistreatments, Dr. Grand’Maison was forced out of her job and the hospital, she said.

“Roswell failed the cancer patients who entrusted their lives to the hospital by ignoring risks to their safety,” Dr. Grand’Maison said in an interview. “The heart of my practice as an oncologist is the well-being of my patients and that is why I could not stay silent.

“I hope that by coming forward, Roswell will be held accountable for putting lives at risk,” she said.
 

Not up to date with best practices

Before joining Roswell, Dr. Grand’Maison had worked at the University of Texas MD Anderson Cancer Center, which is the top cancer center in the nation, noted David E. Gottlieb, a partner at Wigdor, the law firm that is representing her.

MD Anderson has set the standard for sarcoma care, as they treat the highest volume of sarcoma cases of any hospital in North America and they have the best survival outcomes for sarcoma patients, he said in an interview.

“She was bringing this knowledge and background to Roswell Park,” Mr. Gottlieb said. “She felt that Dr. Morrison was not up to date with best practices as far as diagnosing and treating sarcoma, and she raised numerous issues.

“He was not open to being critiqued and even rejected her request to send something out for a second opinion,” Mr. Gottlieb said. “Second opinions are routine in medicine, and it’s the standard of care. We are dealing with a person’s life and it’s not a personal attack – you could be wrong, and getting another opinion can save a patient’s life.”

But Dr. Morrison has been at Roswell Park for many years, is a good friend of Roswell’s president and CEO Candace Johnson, PhD, and is part of the “old guard,” and “really at the top of the organization,” Mr. Gottlieb said  “Whereas Dr. Grand’Maison was relatively new, and her opinions were not popular.”

The complaint was filed against defendants Roswell Park Comprehensive Care Center; Health Research Inc. Roswell Park Division; Candace Johnson, PhD; Carl Morrison, MD, DVM; Renier Brentjens, MD, PhD, deputy director and chair of medicine; and two other senior physicians.