Feature

IgG4 fights viruses and bacteria. However, sometimes it targets the body itself. “This then leads to inflammation, the healing of which the body is unable to keep under control,” explained Ulf Müller-Ladner, MD, PhD, chairperson of the German Society of Internal Medicine.

At the DGIM annual press conference, Dr. Müller-Ladner, who is also director of the department of rheumatology and clinical immunology at the Kerckhoff Clinic in Bad Nauheim, Germany, explained how IgG4 inflammation is triggered throughout the body and what therapeutic options are available.
 

Many manifestations

IgG4-associated inflammation can affect one or more organs or the surrounding connective tissue and cause fibrosis. As a result of fibrosis, the organ gradually loses function and is eventually transformed completely into scarred connective tissue.

“In the case of IgG4-associated inflammation, these fibroses have a histological structure, but extracting a sample is not possible from every affected organ,” said Dr. Müller-Ladner. Liver, bile ducts, blood vessels, skin, eyes, or even the central nervous system – practically every organ system can be affected by these inflammatory reactions.

IgG4-associated diseases have likely been around for some time, but it is only in the past 10 years that awareness has grown that, despite various manifestations, “they are all one and the same disease,” said Dr. Müller-Ladner.

IgG4-associated chronic, inflammatory, fibrosing diseases were only classified together as a single entity in the past few years. In terms of pathophysiology, B lymphocytes, IgG4-positive plasma cells, follicular T-helper cells, cytotoxic CD4-positive T cells, and macrophages work together and trigger an inflammatory reaction, which then encourages fibroblasts to overproduce connective tissue.
 

Beware inexplicable inflammation

It is estimated that 1 in 100,000 people suffer from the disease, but the number of incorrectly categorized patients may be significantly higher.

The diagnostic challenge lies in the fact that IgG4-associated inflammation occurs in almost every organ. It can cause different symptoms, depending on the organ affected.

Dr. Müller-Ladner provided the following take-home message: “Every inexplicable inflammation event and every organ dysfunction, especially if associated with an increase in connective tissue, could be an IgG4-associated disease. Keeping this in mind is the key to recovery.”

With most people, the inflammation persists for many years before any symptoms of the disease develop. Highly acute courses of progression are also possible.

Classic symptoms, such as fever, are not so characteristic of the latent inflammatory reaction, and according to classification criteria published by specialist rheumatology societies, they are an exclusion criterion. This is true with respect to the differential diagnosis for vasculitis, which also occurs throughout the body.
 

Histology is key

Blood levels of IgG4 and imaging are not always enough to confirm the diagnosis. In such cases, the histology is often a crucial factor in making a definitive diagnosis. Dominant organs in IgG4-associated diseases are the pancreas, the liver, the gallbladder, the intestines, the retroperitoneum, large blood vessels, the kidneys, the heart, the brain, saliva, tear ducts, as well all of the body’s connective tissue.

The kidneys play host to inflammation in the connective tissue and space-occupying masses in particular. “If the pancreas is affected, the signs can vary from diffuse swelling to the onset of diabetes mellitus. In contrast, if the aorta is affected, then the inflammation is characterized through a thickening of the vessel walls, aneurysms, and the corresponding circulation disorders,” said Dr. Müller-Ladner.

Because of the long period before the diagnosis is made, more than 50% of patients exhibit irreversible organ damage at the time of diagnosis, he added.
 

Glucocorticoids and immunosuppressants

Despite therapeutic intervention, the disease can have a fatal outcome, even if the patient is young, said Dr. Müller-Ladner. Glucocorticoids are the current therapy of choice. The dose is more than 0.5 mg of prednisolone equivalent per kg of body weight. “This usually leads to a rapid improvement in the inflammation. Subsequently, every organ is thoroughly diagnosed to assess the severity of the disease and to plan further treatment steps.”

In the long term, proven immunosuppressants, such as azathioprine, mycophenolate, leflunomide, and methotrexate, can be used, just as for many other chronic inflammatory diseases. Cyclophosphamide or cyclosporine is used more rarely, owing to their side effect profiles.

Because of the B-cell dominance, B-cell–depleting therapy with rituximab is currently a highly effective therapeutic option but one that must be applied for, because such use is off label. “If the body responds well to the medication, organ function often recovers,” said Dr. Müller-Ladner.

This article was translated from the Medscape German edition. A version appeared on Medscape.com.

IgG4 fights viruses and bacteria. However, sometimes it targets the body itself. “This then leads to inflammation, the healing of which the body is unable to keep under control,” explained Ulf Müller-Ladner, MD, PhD, chairperson of the German Society of Internal Medicine.

At the DGIM annual press conference, Dr. Müller-Ladner, who is also director of the department of rheumatology and clinical immunology at the Kerckhoff Clinic in Bad Nauheim, Germany, explained how IgG4 inflammation is triggered throughout the body and what therapeutic options are available.
 

Many manifestations

IgG4-associated inflammation can affect one or more organs or the surrounding connective tissue and cause fibrosis. As a result of fibrosis, the organ gradually loses function and is eventually transformed completely into scarred connective tissue.

“In the case of IgG4-associated inflammation, these fibroses have a histological structure, but extracting a sample is not possible from every affected organ,” said Dr. Müller-Ladner. Liver, bile ducts, blood vessels, skin, eyes, or even the central nervous system – practically every organ system can be affected by these inflammatory reactions.

IgG4-associated diseases have likely been around for some time, but it is only in the past 10 years that awareness has grown that, despite various manifestations, “they are all one and the same disease,” said Dr. Müller-Ladner.

IgG4-associated chronic, inflammatory, fibrosing diseases were only classified together as a single entity in the past few years. In terms of pathophysiology, B lymphocytes, IgG4-positive plasma cells, follicular T-helper cells, cytotoxic CD4-positive T cells, and macrophages work together and trigger an inflammatory reaction, which then encourages fibroblasts to overproduce connective tissue.
 

Beware inexplicable inflammation

It is estimated that 1 in 100,000 people suffer from the disease, but the number of incorrectly categorized patients may be significantly higher.

The diagnostic challenge lies in the fact that IgG4-associated inflammation occurs in almost every organ. It can cause different symptoms, depending on the organ affected.

Dr. Müller-Ladner provided the following take-home message: “Every inexplicable inflammation event and every organ dysfunction, especially if associated with an increase in connective tissue, could be an IgG4-associated disease. Keeping this in mind is the key to recovery.”

With most people, the inflammation persists for many years before any symptoms of the disease develop. Highly acute courses of progression are also possible.

Classic symptoms, such as fever, are not so characteristic of the latent inflammatory reaction, and according to classification criteria published by specialist rheumatology societies, they are an exclusion criterion. This is true with respect to the differential diagnosis for vasculitis, which also occurs throughout the body.
 

Histology is key

Blood levels of IgG4 and imaging are not always enough to confirm the diagnosis. In such cases, the histology is often a crucial factor in making a definitive diagnosis. Dominant organs in IgG4-associated diseases are the pancreas, the liver, the gallbladder, the intestines, the retroperitoneum, large blood vessels, the kidneys, the heart, the brain, saliva, tear ducts, as well all of the body’s connective tissue.

The kidneys play host to inflammation in the connective tissue and space-occupying masses in particular. “If the pancreas is affected, the signs can vary from diffuse swelling to the onset of diabetes mellitus. In contrast, if the aorta is affected, then the inflammation is characterized through a thickening of the vessel walls, aneurysms, and the corresponding circulation disorders,” said Dr. Müller-Ladner.

Because of the long period before the diagnosis is made, more than 50% of patients exhibit irreversible organ damage at the time of diagnosis, he added.
 

Glucocorticoids and immunosuppressants

Despite therapeutic intervention, the disease can have a fatal outcome, even if the patient is young, said Dr. Müller-Ladner. Glucocorticoids are the current therapy of choice. The dose is more than 0.5 mg of prednisolone equivalent per kg of body weight. “This usually leads to a rapid improvement in the inflammation. Subsequently, every organ is thoroughly diagnosed to assess the severity of the disease and to plan further treatment steps.”

In the long term, proven immunosuppressants, such as azathioprine, mycophenolate, leflunomide, and methotrexate, can be used, just as for many other chronic inflammatory diseases. Cyclophosphamide or cyclosporine is used more rarely, owing to their side effect profiles.

Because of the B-cell dominance, B-cell–depleting therapy with rituximab is currently a highly effective therapeutic option but one that must be applied for, because such use is off label. “If the body responds well to the medication, organ function often recovers,” said Dr. Müller-Ladner.

This article was translated from the Medscape German edition. A version appeared on Medscape.com.

IgG4 fights viruses and bacteria. However, sometimes it targets the body itself. “This then leads to inflammation, the healing of which the body is unable to keep under control,” explained Ulf Müller-Ladner, MD, PhD, chairperson of the German Society of Internal Medicine.

At the DGIM annual press conference, Dr. Müller-Ladner, who is also director of the department of rheumatology and clinical immunology at the Kerckhoff Clinic in Bad Nauheim, Germany, explained how IgG4 inflammation is triggered throughout the body and what therapeutic options are available.
 

Many manifestations

IgG4-associated inflammation can affect one or more organs or the surrounding connective tissue and cause fibrosis. As a result of fibrosis, the organ gradually loses function and is eventually transformed completely into scarred connective tissue.

“In the case of IgG4-associated inflammation, these fibroses have a histological structure, but extracting a sample is not possible from every affected organ,” said Dr. Müller-Ladner. Liver, bile ducts, blood vessels, skin, eyes, or even the central nervous system – practically every organ system can be affected by these inflammatory reactions.

IgG4-associated diseases have likely been around for some time, but it is only in the past 10 years that awareness has grown that, despite various manifestations, “they are all one and the same disease,” said Dr. Müller-Ladner.

IgG4-associated chronic, inflammatory, fibrosing diseases were only classified together as a single entity in the past few years. In terms of pathophysiology, B lymphocytes, IgG4-positive plasma cells, follicular T-helper cells, cytotoxic CD4-positive T cells, and macrophages work together and trigger an inflammatory reaction, which then encourages fibroblasts to overproduce connective tissue.
 

Beware inexplicable inflammation

It is estimated that 1 in 100,000 people suffer from the disease, but the number of incorrectly categorized patients may be significantly higher.

The diagnostic challenge lies in the fact that IgG4-associated inflammation occurs in almost every organ. It can cause different symptoms, depending on the organ affected.

Dr. Müller-Ladner provided the following take-home message: “Every inexplicable inflammation event and every organ dysfunction, especially if associated with an increase in connective tissue, could be an IgG4-associated disease. Keeping this in mind is the key to recovery.”

With most people, the inflammation persists for many years before any symptoms of the disease develop. Highly acute courses of progression are also possible.

Classic symptoms, such as fever, are not so characteristic of the latent inflammatory reaction, and according to classification criteria published by specialist rheumatology societies, they are an exclusion criterion. This is true with respect to the differential diagnosis for vasculitis, which also occurs throughout the body.
 

Histology is key

Blood levels of IgG4 and imaging are not always enough to confirm the diagnosis. In such cases, the histology is often a crucial factor in making a definitive diagnosis. Dominant organs in IgG4-associated diseases are the pancreas, the liver, the gallbladder, the intestines, the retroperitoneum, large blood vessels, the kidneys, the heart, the brain, saliva, tear ducts, as well all of the body’s connective tissue.

The kidneys play host to inflammation in the connective tissue and space-occupying masses in particular. “If the pancreas is affected, the signs can vary from diffuse swelling to the onset of diabetes mellitus. In contrast, if the aorta is affected, then the inflammation is characterized through a thickening of the vessel walls, aneurysms, and the corresponding circulation disorders,” said Dr. Müller-Ladner.

Because of the long period before the diagnosis is made, more than 50% of patients exhibit irreversible organ damage at the time of diagnosis, he added.
 

Glucocorticoids and immunosuppressants

Despite therapeutic intervention, the disease can have a fatal outcome, even if the patient is young, said Dr. Müller-Ladner. Glucocorticoids are the current therapy of choice. The dose is more than 0.5 mg of prednisolone equivalent per kg of body weight. “This usually leads to a rapid improvement in the inflammation. Subsequently, every organ is thoroughly diagnosed to assess the severity of the disease and to plan further treatment steps.”

In the long term, proven immunosuppressants, such as azathioprine, mycophenolate, leflunomide, and methotrexate, can be used, just as for many other chronic inflammatory diseases. Cyclophosphamide or cyclosporine is used more rarely, owing to their side effect profiles.

Because of the B-cell dominance, B-cell–depleting therapy with rituximab is currently a highly effective therapeutic option but one that must be applied for, because such use is off label. “If the body responds well to the medication, organ function often recovers,” said Dr. Müller-Ladner.

This article was translated from the Medscape German edition. A version appeared on Medscape.com.

The study covered in this summary was published on researchsquare.com as a preprint and has not yet been peer reviewed.

Key takeaway

• Adding hyperthermic intraperitoneal chemotherapy to systemic chemotherapy after radical gastrectomy reduces the occurrence of peritoneal metastases and improves disease-free survival (DFS) for patients with locally advanced gastric cancer.

Why this matters

• Surgery and postoperative chemotherapy are standard of care for advanced gastric cancer, but up to half of patients develop peritoneal metastases with poor prognosis.
• There is no consensus on how to prevent peritoneal metastases.
• With hyperthermic intraperitoneal chemotherapy, the abdominal cavity is bathed in chemotherapy that has been heated, directly killing free cancer cells and micrometastases.
• The findings suggest that adding hyperthermic intraperitoneal chemotherapy to standard treatment greatly reduces the risk of peritoneal metastases.

Study design

• The investigators randomly assigned 134 patients with advanced gastric cancer evenly to receive either systemic chemotherapy alone or systemic chemotherapy plus hyperthermic intraperitoneal chemotherapy after radical gastrectomy.
• The hyperthermic intraperitoneal chemotherapy group had 3 L of heated saline containing 40 mg/m² of cisplatin circulated in their peritoneal cavities for an hour. The procedure was performed twice within 72 hours of surgery.
• Systemic chemotherapy consisted of six to eight cycles of S-1 combined with oxaliplatin (SOX regimen) starting 4-6 weeks after surgery.
• Most patients (90%) had stage III disease, and the rest stage II.
• Median follow-up was 44 months.

Key results

• Overall, the 3-year DFS rate was 73.8% with hyperthermic intraperitoneal chemotherapy versus 61.2% without it (P = .031).
• In addition, 21% of patients in the hyperthermic intraperitoneal chemotherapy group developed peritoneal metastases versus 40.3% with standard care (P = .015)
• The 3-year overall survival was 73.9% in the hyperthermic intraperitoneal chemotherapy group versus 77.6% in the standard care arm, but the difference was not significant (P = .737).
• There were no serious adverse events related to hyperthermic intraperitoneal chemotherapy, and postoperative complications were similar between the groups.
• Grade 3 or 4 adverse events occurred in 14.2% of patients; there were no statistically significant between-group differences.
• Metastases to other sites, such as the liver and distant lymph nodes, were also similar between the two arms.

Limitations

• Follow-up might have been too short to detect a difference in overall survival.
• The trial was conducted at a single-center and was relatively small.

Disclosures

• The study received no external funding, and the investigators did not report any financial relationships.

This is a summary of a preprint research study, “Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Locally Advanced Gastric Cancer After D2 Radical Resection: A Randomized Controlled Study,” led by Pengfei Yu of the Zhejiang Cancer Hospital, Hangzhou, China. The study has not been peer reviewed. The full text can be found at researchsquare.com.

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

The study covered in this summary was published on researchsquare.com as a preprint and has not yet been peer reviewed.

Key takeaway

• Adding hyperthermic intraperitoneal chemotherapy to systemic chemotherapy after radical gastrectomy reduces the occurrence of peritoneal metastases and improves disease-free survival (DFS) for patients with locally advanced gastric cancer.

Why this matters

• Surgery and postoperative chemotherapy are standard of care for advanced gastric cancer, but up to half of patients develop peritoneal metastases with poor prognosis.
• There is no consensus on how to prevent peritoneal metastases.
• With hyperthermic intraperitoneal chemotherapy, the abdominal cavity is bathed in chemotherapy that has been heated, directly killing free cancer cells and micrometastases.
• The findings suggest that adding hyperthermic intraperitoneal chemotherapy to standard treatment greatly reduces the risk of peritoneal metastases.

Study design

• The investigators randomly assigned 134 patients with advanced gastric cancer evenly to receive either systemic chemotherapy alone or systemic chemotherapy plus hyperthermic intraperitoneal chemotherapy after radical gastrectomy.
• The hyperthermic intraperitoneal chemotherapy group had 3 L of heated saline containing 40 mg/m² of cisplatin circulated in their peritoneal cavities for an hour. The procedure was performed twice within 72 hours of surgery.
• Systemic chemotherapy consisted of six to eight cycles of S-1 combined with oxaliplatin (SOX regimen) starting 4-6 weeks after surgery.
• Most patients (90%) had stage III disease, and the rest stage II.
• Median follow-up was 44 months.

Key results

• Overall, the 3-year DFS rate was 73.8% with hyperthermic intraperitoneal chemotherapy versus 61.2% without it (P = .031).
• In addition, 21% of patients in the hyperthermic intraperitoneal chemotherapy group developed peritoneal metastases versus 40.3% with standard care (P = .015)
• The 3-year overall survival was 73.9% in the hyperthermic intraperitoneal chemotherapy group versus 77.6% in the standard care arm, but the difference was not significant (P = .737).
• There were no serious adverse events related to hyperthermic intraperitoneal chemotherapy, and postoperative complications were similar between the groups.
• Grade 3 or 4 adverse events occurred in 14.2% of patients; there were no statistically significant between-group differences.
• Metastases to other sites, such as the liver and distant lymph nodes, were also similar between the two arms.

Limitations

• Follow-up might have been too short to detect a difference in overall survival.
• The trial was conducted at a single-center and was relatively small.

Disclosures

• The study received no external funding, and the investigators did not report any financial relationships.

This is a summary of a preprint research study, “Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Locally Advanced Gastric Cancer After D2 Radical Resection: A Randomized Controlled Study,” led by Pengfei Yu of the Zhejiang Cancer Hospital, Hangzhou, China. The study has not been peer reviewed. The full text can be found at researchsquare.com.

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

The study covered in this summary was published on researchsquare.com as a preprint and has not yet been peer reviewed.

Key takeaway

• Adding hyperthermic intraperitoneal chemotherapy to systemic chemotherapy after radical gastrectomy reduces the occurrence of peritoneal metastases and improves disease-free survival (DFS) for patients with locally advanced gastric cancer.

Why this matters

• Surgery and postoperative chemotherapy are standard of care for advanced gastric cancer, but up to half of patients develop peritoneal metastases with poor prognosis.
• There is no consensus on how to prevent peritoneal metastases.
• With hyperthermic intraperitoneal chemotherapy, the abdominal cavity is bathed in chemotherapy that has been heated, directly killing free cancer cells and micrometastases.
• The findings suggest that adding hyperthermic intraperitoneal chemotherapy to standard treatment greatly reduces the risk of peritoneal metastases.

Study design

• The investigators randomly assigned 134 patients with advanced gastric cancer evenly to receive either systemic chemotherapy alone or systemic chemotherapy plus hyperthermic intraperitoneal chemotherapy after radical gastrectomy.
• The hyperthermic intraperitoneal chemotherapy group had 3 L of heated saline containing 40 mg/m² of cisplatin circulated in their peritoneal cavities for an hour. The procedure was performed twice within 72 hours of surgery.
• Systemic chemotherapy consisted of six to eight cycles of S-1 combined with oxaliplatin (SOX regimen) starting 4-6 weeks after surgery.
• Most patients (90%) had stage III disease, and the rest stage II.
• Median follow-up was 44 months.

Key results

• Overall, the 3-year DFS rate was 73.8% with hyperthermic intraperitoneal chemotherapy versus 61.2% without it (P = .031).
• In addition, 21% of patients in the hyperthermic intraperitoneal chemotherapy group developed peritoneal metastases versus 40.3% with standard care (P = .015)
• The 3-year overall survival was 73.9% in the hyperthermic intraperitoneal chemotherapy group versus 77.6% in the standard care arm, but the difference was not significant (P = .737).
• There were no serious adverse events related to hyperthermic intraperitoneal chemotherapy, and postoperative complications were similar between the groups.
• Grade 3 or 4 adverse events occurred in 14.2% of patients; there were no statistically significant between-group differences.
• Metastases to other sites, such as the liver and distant lymph nodes, were also similar between the two arms.

Limitations

• Follow-up might have been too short to detect a difference in overall survival.
• The trial was conducted at a single-center and was relatively small.

Disclosures

• The study received no external funding, and the investigators did not report any financial relationships.

This is a summary of a preprint research study, “Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Locally Advanced Gastric Cancer After D2 Radical Resection: A Randomized Controlled Study,” led by Pengfei Yu of the Zhejiang Cancer Hospital, Hangzhou, China. The study has not been peer reviewed. The full text can be found at researchsquare.com.

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

It was Friday, and oncologist Coral Olazagasti, MD, faced a ticking clock.

Her patient had taken his last prescription antinausea pill. Without a refill of ondansetron, he faced a long, painful weekend.

The patient – a man with HPV-related oropharyngeal cancer – was experiencing severe side effects from standard chemoradiation with weekly cisplatin. Intense nausea and grade 3 mucositis, in particular, left him struggling to swallow or take in any food or fluids.

He was on 8 mg of ondansetron (Zofran) every 8 hours, as needed, to keep the nausea at bay. The pills along with a feeding tube helped, but his symptoms were so intense, neither was quite enough.

“He still needed to be hospitalized twice for dehydration,” said Dr. Olazagasti, who specializes in head and neck medical cancer at Sylvester Comprehensive Cancer Center in Miami.

But when it came time to renew his ondansetron prescription, his insurance company denied it.

The reasoning: “The company had only approved 30 tablets a month and, for them, it was unjustifiable to approve anything above that amount,” Dr. Olazagasti explained.

After Dr. Olazagasti called the insurance company to resolve the issue, a company representative told her to fill out a prior authorization form.

But it was already after 7:30 p.m. ET on Friday.

At that point, finding the prior authorization documents, filling them out, and submitting them would take more time – and the paperwork couldn’t be filed until Monday.

“My patient was at home with zero tablets left and horrible symptoms. He couldn’t keep anything down,” Dr. Olazagasti said.

On Monday, the oncology team sent the prior authorization request, and her patient received his medication a few days later.

“My patient had to wait about 5 days to get the nausea meds he needed,” she said. In the meantime, he was in pain. “Having a refill of this simple supportive care medication rejected was infuriating.”

When Dr. Olazagasti vented her frustrations on Twitter, several people chimed in, suggesting purchasing the drug at a discount through GoodRx or Cost Plus instead of going through the insurance company.

At Cost Plus, for instance, 30 8-mg pills would cost $6.30, but ordering from the online pharmacy would mean waiting several days for delivery.

Discounts through GoodRx may provide a potentially faster solution in a pinch, but the pharmacy matters. In Miami, 30 8-mg pills would cost $19.99 at Costco with a GoodRx coupon, but $233.56 at CVS and $253.60 at Walgreens.

Although potentially useful, these options may not be the obvious choice for oncologists and patients, especially when a drug has already been approved and covered by the insurer. In this case, the denial was also a surprise, which left Dr. Olazagasti and her patient scrambling right before the weekend.

In addition, companies providing discounted generic drugs may only have a limited number of oncology-related medications. Cost Plus, for instance, now sells more than 1,000 generic prescription drugs at a fraction of what insurance companies charge, but only about 7 are cancer drugs.

On a broader level, Dr. Olazagasti noted, “insurance companies have a responsibility to cover these drugs. If we all get so fed up that we start relying on alternate routes to get patients their treatments, then insurance companies are let off the hook.”

However, using an alternative option like GoodRx or CostPlus could mean bypassing insurance company obstacles in certain cases.

“The hurdles someone may have to go through to get a generic drug approved are very frustrating,” said Stacie B. Dusetzina, PhD, professor of health policy and a professor of cancer research at Vanderbilt University in Nashville, Tenn.

In a weekend emergency situation, if the drug is discounted through GoodRx, “it can be a good backup strategy to send the prescription to the pharmacy” and more generally “worth it for patients to check if they can get a better deal on generic drugs through these companies.”

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

It was Friday, and oncologist Coral Olazagasti, MD, faced a ticking clock.

Her patient had taken his last prescription antinausea pill. Without a refill of ondansetron, he faced a long, painful weekend.

The patient – a man with HPV-related oropharyngeal cancer – was experiencing severe side effects from standard chemoradiation with weekly cisplatin. Intense nausea and grade 3 mucositis, in particular, left him struggling to swallow or take in any food or fluids.

He was on 8 mg of ondansetron (Zofran) every 8 hours, as needed, to keep the nausea at bay. The pills along with a feeding tube helped, but his symptoms were so intense, neither was quite enough.

“He still needed to be hospitalized twice for dehydration,” said Dr. Olazagasti, who specializes in head and neck medical cancer at Sylvester Comprehensive Cancer Center in Miami.

But when it came time to renew his ondansetron prescription, his insurance company denied it.

The reasoning: “The company had only approved 30 tablets a month and, for them, it was unjustifiable to approve anything above that amount,” Dr. Olazagasti explained.

After Dr. Olazagasti called the insurance company to resolve the issue, a company representative told her to fill out a prior authorization form.

But it was already after 7:30 p.m. ET on Friday.

At that point, finding the prior authorization documents, filling them out, and submitting them would take more time – and the paperwork couldn’t be filed until Monday.

“My patient was at home with zero tablets left and horrible symptoms. He couldn’t keep anything down,” Dr. Olazagasti said.

On Monday, the oncology team sent the prior authorization request, and her patient received his medication a few days later.

“My patient had to wait about 5 days to get the nausea meds he needed,” she said. In the meantime, he was in pain. “Having a refill of this simple supportive care medication rejected was infuriating.”

When Dr. Olazagasti vented her frustrations on Twitter, several people chimed in, suggesting purchasing the drug at a discount through GoodRx or Cost Plus instead of going through the insurance company.

At Cost Plus, for instance, 30 8-mg pills would cost $6.30, but ordering from the online pharmacy would mean waiting several days for delivery.

Discounts through GoodRx may provide a potentially faster solution in a pinch, but the pharmacy matters. In Miami, 30 8-mg pills would cost $19.99 at Costco with a GoodRx coupon, but $233.56 at CVS and $253.60 at Walgreens.

Although potentially useful, these options may not be the obvious choice for oncologists and patients, especially when a drug has already been approved and covered by the insurer. In this case, the denial was also a surprise, which left Dr. Olazagasti and her patient scrambling right before the weekend.

In addition, companies providing discounted generic drugs may only have a limited number of oncology-related medications. Cost Plus, for instance, now sells more than 1,000 generic prescription drugs at a fraction of what insurance companies charge, but only about 7 are cancer drugs.

On a broader level, Dr. Olazagasti noted, “insurance companies have a responsibility to cover these drugs. If we all get so fed up that we start relying on alternate routes to get patients their treatments, then insurance companies are let off the hook.”

However, using an alternative option like GoodRx or CostPlus could mean bypassing insurance company obstacles in certain cases.

“The hurdles someone may have to go through to get a generic drug approved are very frustrating,” said Stacie B. Dusetzina, PhD, professor of health policy and a professor of cancer research at Vanderbilt University in Nashville, Tenn.

In a weekend emergency situation, if the drug is discounted through GoodRx, “it can be a good backup strategy to send the prescription to the pharmacy” and more generally “worth it for patients to check if they can get a better deal on generic drugs through these companies.”

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

It was Friday, and oncologist Coral Olazagasti, MD, faced a ticking clock.

Her patient had taken his last prescription antinausea pill. Without a refill of ondansetron, he faced a long, painful weekend.

The patient – a man with HPV-related oropharyngeal cancer – was experiencing severe side effects from standard chemoradiation with weekly cisplatin. Intense nausea and grade 3 mucositis, in particular, left him struggling to swallow or take in any food or fluids.

He was on 8 mg of ondansetron (Zofran) every 8 hours, as needed, to keep the nausea at bay. The pills along with a feeding tube helped, but his symptoms were so intense, neither was quite enough.

“He still needed to be hospitalized twice for dehydration,” said Dr. Olazagasti, who specializes in head and neck medical cancer at Sylvester Comprehensive Cancer Center in Miami.

But when it came time to renew his ondansetron prescription, his insurance company denied it.

The reasoning: “The company had only approved 30 tablets a month and, for them, it was unjustifiable to approve anything above that amount,” Dr. Olazagasti explained.

After Dr. Olazagasti called the insurance company to resolve the issue, a company representative told her to fill out a prior authorization form.

But it was already after 7:30 p.m. ET on Friday.

At that point, finding the prior authorization documents, filling them out, and submitting them would take more time – and the paperwork couldn’t be filed until Monday.

“My patient was at home with zero tablets left and horrible symptoms. He couldn’t keep anything down,” Dr. Olazagasti said.

On Monday, the oncology team sent the prior authorization request, and her patient received his medication a few days later.

“My patient had to wait about 5 days to get the nausea meds he needed,” she said. In the meantime, he was in pain. “Having a refill of this simple supportive care medication rejected was infuriating.”

When Dr. Olazagasti vented her frustrations on Twitter, several people chimed in, suggesting purchasing the drug at a discount through GoodRx or Cost Plus instead of going through the insurance company.

At Cost Plus, for instance, 30 8-mg pills would cost $6.30, but ordering from the online pharmacy would mean waiting several days for delivery.

Discounts through GoodRx may provide a potentially faster solution in a pinch, but the pharmacy matters. In Miami, 30 8-mg pills would cost $19.99 at Costco with a GoodRx coupon, but $233.56 at CVS and $253.60 at Walgreens.

Although potentially useful, these options may not be the obvious choice for oncologists and patients, especially when a drug has already been approved and covered by the insurer. In this case, the denial was also a surprise, which left Dr. Olazagasti and her patient scrambling right before the weekend.

In addition, companies providing discounted generic drugs may only have a limited number of oncology-related medications. Cost Plus, for instance, now sells more than 1,000 generic prescription drugs at a fraction of what insurance companies charge, but only about 7 are cancer drugs.

On a broader level, Dr. Olazagasti noted, “insurance companies have a responsibility to cover these drugs. If we all get so fed up that we start relying on alternate routes to get patients their treatments, then insurance companies are let off the hook.”

However, using an alternative option like GoodRx or CostPlus could mean bypassing insurance company obstacles in certain cases.

“The hurdles someone may have to go through to get a generic drug approved are very frustrating,” said Stacie B. Dusetzina, PhD, professor of health policy and a professor of cancer research at Vanderbilt University in Nashville, Tenn.

In a weekend emergency situation, if the drug is discounted through GoodRx, “it can be a good backup strategy to send the prescription to the pharmacy” and more generally “worth it for patients to check if they can get a better deal on generic drugs through these companies.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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

Physicians routinely monitor cholesterol, blood pressure, and glucose levels to get a clearer picture of their patients’ overall health. But a group of experts argues that having an accurate read of a person’s ability to absorb oxygen during peak exertion – VO₂ max – is just as important.

Once the focus of cyclists and other elite athletes, VO₂ max has in recent years caught the attention of geriatricians, who have linked the measure to maximum functional capacity – an umbrella term for the body’s ability to perform aerobic exercise.

“Function is prognostic of mortality,” said Daniel E. Forman, MD, FAHA, FACC, professor of medicine and chair of the section of geriatric cardiology at the University of Pittsburgh Medical Center. “If you aren’t looking at that, you’re missing the boat.”

Although cardiopulmonary exercise testing (CPET) remains the gold standard for assessing VO₂ max, Dr. Forman said clinicians often overlook CPET because it is old.
 

Getting precise

As a person ages, the amount of physical activity needed to stay fit varies, depending on genes, health, and fitness history. Measuring VO₂ max can help doctors better prescribe physical activity, both with regard to specific exercises and for how long, Claudio Gil Araújo, MD, PhD, dean of research and education at the Exercise Medicine Clinic at CLINIMEX in Rio de Janeiro, Brazil, told this news organization. The test can also measure progress.

“Guidelines talk about how much exercise you should do every week, but it’s somewhat misleading because the health outcomes are much more linked to physical fitness than the amount of exercise you do,” Dr. Araújo said. Treating a patient with hypertension requires an individualized approach. “The same thing is true with exercise,” he said.

A person with high aerobic fitness, either because of favorable genetics or because he or she has maintained good fitness by exercising, may need less activity, but 200 minutes per week may not be enough for someone else.

In his own lab, Dr. Araújo is following “dozens” of men and women who have been able to increase their ability to exercise – especially high-intensity activity – over time. And their VO₂ max readings have risen, he said.

Getting patients moving and collecting data on VO₂ max is the most precise way to measure aerobic fitness. But the test is far from a staple in primary care.

Dr. Araújo said a growing body of research has long shown VO₂ max to be a significant determinant of health and one that physicians should be paying closer attention to, especially for aging patients.

“If someone has a low VO₂ max, the treatment to correct this unfavorable health profile is to increase exercise levels,” Dr. Araújo said. “This is a very relevant public health message.”

Investigators have found that inactivity increases a person’s risk of dying from an atherosclerotic cardiovascular disease event by about the same amount as smoking, and that a sedentary lifestyle increases with age . A patient’s fitness is crucial to his or her overall health, and VO₂ max can play a key role. Poor performance on CPET could be a warning regarding a number of conditions, particularly cardiovascular and lung disease, Dr. Araújo said.

Indeed, acing the CPET is not easy.

“Your joints have to be normal, you can’t have low potassium, low sodium, or high blood sugar, your heart has to pump well, your blood vessels have to be healthy,” said Thomas Allison, PhD, MPH, director of the Integrated Stress Testing Center and the Sports Cardiology Clinic at Mayo Clinic, in Rochester, Minn. “All of those things can show up on the treadmill in terms of your VO₂ max.”

Low VO₂ max can be a physician’s first indication to investigate further. A review published in November 2022 in the International Journal of Cardiology Cardiovascular Risk and Prevention outlined what cross-sectional and longitudinal studies have documented regarding how VO₂ max changes as people age. From ages 18 to 35, VO₂ max remains fairly consistent. Between 35 and 55, it drops slightly but inexorably before falling sharply, if inconsistently. This inconsistency is where the important data lie.

“That lower level of physical activity may just be a behavioral change that needs to be reversed, or it could be a change that has been forced by underlying occult disease,” Dr. Allison said. That older people can’t run as fast as young people or are more likely to die in a given period than young people is not surprising. “The question is, at any given age, does your fitness level predict good health outcomes?” he said. “And the answer is yes.”

Fitness should be treated as any other data point, he added.

“If I want to know your blood pressure, I’m going to check your blood pressure; I’m not going to just ask you what it is,” Dr. Allison said. “If I ask if you have any limitations or symptoms with exercise or how physically active you are, if possible, I want to check that.”
 

Culture shift

Dr. Forman acknowledged that VO₂ max tests can be difficult and expensive to administer in offices that aren’t already equipped with CPET machines. He said conducting other assessments, such as observing the patient performing a short walk, won’t provide as accurate data but is better than not assessing function at all.

“Specialists all have different things they measure, but function is the common denominator. For an aging population, it is the number one thing we should be looking at,” Dr. Forman said. “It’s a skill set, it’s an investment, it’s a change in culture at a time when cardiologists are obsessed with getting the latest imaging machines.”

Dr. Allison said all cardiologists should assess their patients’ VO₂ max and that family medicine doctors should use the test for certain patients, such as those who have gained an unusual amount of weight or report being out of breath more than usual.

“We have all sorts of things that can go wrong with us as we get older, but if we’re sitting in a doctor’s office, it may not be apparent what they are,” Dr. Allison said. “We have to get patients up and moving.”

The authors have disclosed no relevant financial relationships.

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

Physicians routinely monitor cholesterol, blood pressure, and glucose levels to get a clearer picture of their patients’ overall health. But a group of experts argues that having an accurate read of a person’s ability to absorb oxygen during peak exertion – VO₂ max – is just as important.

Once the focus of cyclists and other elite athletes, VO₂ max has in recent years caught the attention of geriatricians, who have linked the measure to maximum functional capacity – an umbrella term for the body’s ability to perform aerobic exercise.

“Function is prognostic of mortality,” said Daniel E. Forman, MD, FAHA, FACC, professor of medicine and chair of the section of geriatric cardiology at the University of Pittsburgh Medical Center. “If you aren’t looking at that, you’re missing the boat.”

Although cardiopulmonary exercise testing (CPET) remains the gold standard for assessing VO₂ max, Dr. Forman said clinicians often overlook CPET because it is old.
 

Getting precise

As a person ages, the amount of physical activity needed to stay fit varies, depending on genes, health, and fitness history. Measuring VO₂ max can help doctors better prescribe physical activity, both with regard to specific exercises and for how long, Claudio Gil Araújo, MD, PhD, dean of research and education at the Exercise Medicine Clinic at CLINIMEX in Rio de Janeiro, Brazil, told this news organization. The test can also measure progress.

“Guidelines talk about how much exercise you should do every week, but it’s somewhat misleading because the health outcomes are much more linked to physical fitness than the amount of exercise you do,” Dr. Araújo said. Treating a patient with hypertension requires an individualized approach. “The same thing is true with exercise,” he said.

A person with high aerobic fitness, either because of favorable genetics or because he or she has maintained good fitness by exercising, may need less activity, but 200 minutes per week may not be enough for someone else.

In his own lab, Dr. Araújo is following “dozens” of men and women who have been able to increase their ability to exercise – especially high-intensity activity – over time. And their VO₂ max readings have risen, he said.

Getting patients moving and collecting data on VO₂ max is the most precise way to measure aerobic fitness. But the test is far from a staple in primary care.

Dr. Araújo said a growing body of research has long shown VO₂ max to be a significant determinant of health and one that physicians should be paying closer attention to, especially for aging patients.

“If someone has a low VO₂ max, the treatment to correct this unfavorable health profile is to increase exercise levels,” Dr. Araújo said. “This is a very relevant public health message.”

Investigators have found that inactivity increases a person’s risk of dying from an atherosclerotic cardiovascular disease event by about the same amount as smoking, and that a sedentary lifestyle increases with age . A patient’s fitness is crucial to his or her overall health, and VO₂ max can play a key role. Poor performance on CPET could be a warning regarding a number of conditions, particularly cardiovascular and lung disease, Dr. Araújo said.

Indeed, acing the CPET is not easy.

“Your joints have to be normal, you can’t have low potassium, low sodium, or high blood sugar, your heart has to pump well, your blood vessels have to be healthy,” said Thomas Allison, PhD, MPH, director of the Integrated Stress Testing Center and the Sports Cardiology Clinic at Mayo Clinic, in Rochester, Minn. “All of those things can show up on the treadmill in terms of your VO₂ max.”

Low VO₂ max can be a physician’s first indication to investigate further. A review published in November 2022 in the International Journal of Cardiology Cardiovascular Risk and Prevention outlined what cross-sectional and longitudinal studies have documented regarding how VO₂ max changes as people age. From ages 18 to 35, VO₂ max remains fairly consistent. Between 35 and 55, it drops slightly but inexorably before falling sharply, if inconsistently. This inconsistency is where the important data lie.

“That lower level of physical activity may just be a behavioral change that needs to be reversed, or it could be a change that has been forced by underlying occult disease,” Dr. Allison said. That older people can’t run as fast as young people or are more likely to die in a given period than young people is not surprising. “The question is, at any given age, does your fitness level predict good health outcomes?” he said. “And the answer is yes.”

Fitness should be treated as any other data point, he added.

“If I want to know your blood pressure, I’m going to check your blood pressure; I’m not going to just ask you what it is,” Dr. Allison said. “If I ask if you have any limitations or symptoms with exercise or how physically active you are, if possible, I want to check that.”
 

Culture shift

Dr. Forman acknowledged that VO₂ max tests can be difficult and expensive to administer in offices that aren’t already equipped with CPET machines. He said conducting other assessments, such as observing the patient performing a short walk, won’t provide as accurate data but is better than not assessing function at all.

“Specialists all have different things they measure, but function is the common denominator. For an aging population, it is the number one thing we should be looking at,” Dr. Forman said. “It’s a skill set, it’s an investment, it’s a change in culture at a time when cardiologists are obsessed with getting the latest imaging machines.”

Dr. Allison said all cardiologists should assess their patients’ VO₂ max and that family medicine doctors should use the test for certain patients, such as those who have gained an unusual amount of weight or report being out of breath more than usual.

“We have all sorts of things that can go wrong with us as we get older, but if we’re sitting in a doctor’s office, it may not be apparent what they are,” Dr. Allison said. “We have to get patients up and moving.”

The authors have disclosed no relevant financial relationships.

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

Physicians routinely monitor cholesterol, blood pressure, and glucose levels to get a clearer picture of their patients’ overall health. But a group of experts argues that having an accurate read of a person’s ability to absorb oxygen during peak exertion – VO₂ max – is just as important.

Once the focus of cyclists and other elite athletes, VO₂ max has in recent years caught the attention of geriatricians, who have linked the measure to maximum functional capacity – an umbrella term for the body’s ability to perform aerobic exercise.

“Function is prognostic of mortality,” said Daniel E. Forman, MD, FAHA, FACC, professor of medicine and chair of the section of geriatric cardiology at the University of Pittsburgh Medical Center. “If you aren’t looking at that, you’re missing the boat.”

Although cardiopulmonary exercise testing (CPET) remains the gold standard for assessing VO₂ max, Dr. Forman said clinicians often overlook CPET because it is old.
 

Getting precise

As a person ages, the amount of physical activity needed to stay fit varies, depending on genes, health, and fitness history. Measuring VO₂ max can help doctors better prescribe physical activity, both with regard to specific exercises and for how long, Claudio Gil Araújo, MD, PhD, dean of research and education at the Exercise Medicine Clinic at CLINIMEX in Rio de Janeiro, Brazil, told this news organization. The test can also measure progress.

“Guidelines talk about how much exercise you should do every week, but it’s somewhat misleading because the health outcomes are much more linked to physical fitness than the amount of exercise you do,” Dr. Araújo said. Treating a patient with hypertension requires an individualized approach. “The same thing is true with exercise,” he said.

A person with high aerobic fitness, either because of favorable genetics or because he or she has maintained good fitness by exercising, may need less activity, but 200 minutes per week may not be enough for someone else.

In his own lab, Dr. Araújo is following “dozens” of men and women who have been able to increase their ability to exercise – especially high-intensity activity – over time. And their VO₂ max readings have risen, he said.

Getting patients moving and collecting data on VO₂ max is the most precise way to measure aerobic fitness. But the test is far from a staple in primary care.

Dr. Araújo said a growing body of research has long shown VO₂ max to be a significant determinant of health and one that physicians should be paying closer attention to, especially for aging patients.

“If someone has a low VO₂ max, the treatment to correct this unfavorable health profile is to increase exercise levels,” Dr. Araújo said. “This is a very relevant public health message.”

Investigators have found that inactivity increases a person’s risk of dying from an atherosclerotic cardiovascular disease event by about the same amount as smoking, and that a sedentary lifestyle increases with age . A patient’s fitness is crucial to his or her overall health, and VO₂ max can play a key role. Poor performance on CPET could be a warning regarding a number of conditions, particularly cardiovascular and lung disease, Dr. Araújo said.

Indeed, acing the CPET is not easy.

“Your joints have to be normal, you can’t have low potassium, low sodium, or high blood sugar, your heart has to pump well, your blood vessels have to be healthy,” said Thomas Allison, PhD, MPH, director of the Integrated Stress Testing Center and the Sports Cardiology Clinic at Mayo Clinic, in Rochester, Minn. “All of those things can show up on the treadmill in terms of your VO₂ max.”

Low VO₂ max can be a physician’s first indication to investigate further. A review published in November 2022 in the International Journal of Cardiology Cardiovascular Risk and Prevention outlined what cross-sectional and longitudinal studies have documented regarding how VO₂ max changes as people age. From ages 18 to 35, VO₂ max remains fairly consistent. Between 35 and 55, it drops slightly but inexorably before falling sharply, if inconsistently. This inconsistency is where the important data lie.

“That lower level of physical activity may just be a behavioral change that needs to be reversed, or it could be a change that has been forced by underlying occult disease,” Dr. Allison said. That older people can’t run as fast as young people or are more likely to die in a given period than young people is not surprising. “The question is, at any given age, does your fitness level predict good health outcomes?” he said. “And the answer is yes.”

Fitness should be treated as any other data point, he added.

“If I want to know your blood pressure, I’m going to check your blood pressure; I’m not going to just ask you what it is,” Dr. Allison said. “If I ask if you have any limitations or symptoms with exercise or how physically active you are, if possible, I want to check that.”
 

Culture shift

Dr. Forman acknowledged that VO₂ max tests can be difficult and expensive to administer in offices that aren’t already equipped with CPET machines. He said conducting other assessments, such as observing the patient performing a short walk, won’t provide as accurate data but is better than not assessing function at all.

“Specialists all have different things they measure, but function is the common denominator. For an aging population, it is the number one thing we should be looking at,” Dr. Forman said. “It’s a skill set, it’s an investment, it’s a change in culture at a time when cardiologists are obsessed with getting the latest imaging machines.”

Dr. Allison said all cardiologists should assess their patients’ VO₂ max and that family medicine doctors should use the test for certain patients, such as those who have gained an unusual amount of weight or report being out of breath more than usual.

“We have all sorts of things that can go wrong with us as we get older, but if we’re sitting in a doctor’s office, it may not be apparent what they are,” Dr. Allison said. “We have to get patients up and moving.”

The authors have disclosed no relevant financial relationships.

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

Slowing progression of, rather than stopping, Alzheimer’s disease (AD) has measurable benefits for patients and families and may be a more realistic goal for clinical AD drug trials, a new report suggests.

The report is a yearlong undertaking by an expert work group convened by the Alzheimer’s Association and was prompted, in part, by the fallout from the U.S. Food and Drug Administration’s controversial decision to grant aducanumab (Aduhelm) accelerated approval, which came over the objection of an advisory panel that found the drug was ineffective.

The report’s authors call for a “reframing” of how researchers define “clinically meaningful” in randomized controlled trials (RCTs), noting that it’s time to adjust expectations of outcomes from relatively short clinical trials.

“Without lowering the bar, are we expecting too much from a clinical trial by expecting that unless the disease is halted in its tracks and there’s no progression, we failed at treatment?” the report’s lead author and group leader Ronald C. Petersen, MD, PhD, lead author, chair of the work group, and professor of neurology at the Mayo Clinic, Rochester, Minn., told this news organization.

Interpretations of clinical meaningfulness are used in the drug approval process and in decisions about whether an insurer will cover the cost of treatment, the authors note.

While the report doesn’t provide a consensus definition of clinically meaningful benefit, it does offer a starting point for a conversation about how the phrase should be defined in the context of RCTs for disease-modifying therapies (DMTs) in AD, Dr. Petersen said.

“What we tried to do was to put it into some kind of perspective and at least have people reflect on this: If you’re going to design the perfect drug trial in Alzheimer’s disease, what would it be? We wanted to get people to think about it without digging in their heels for or against,” he added.

The report was published online  in Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association.
 

A proactive measure

The expert group began its work in January 2022, less than a year after the FDA approved aducanumab. Since the panel began its work, the FDA has approved a second AD drug, lecanemab (Leqembi), and denied accelerated approval of a third medication, donanemab.

“At the time we started this group, we had one approved treatment, and we just knew that there were others on the way, and we needed to be prepared to have this conversation and be more proactive than reactive,” Christopher Weber, PhD, director of global science initiatives for the Alzheimer’s Association and co-author of the report, said in an interview.

The work group suggests that simply slowing disease progression might be a desired goal for drug trials, especially early on, before cognition and memory are affected.

They also note that a benefit identified during an 18-month clinical trial may ultimately lead to even more meaningful changes over coming years, well beyond the trial’s end.

In addition, the report authors call for the development of better research tools to more accurately assess meaningful change. The Clinical Dementia Rating (CDR) scale is currently the key instrument used as a primary outcome measure in RCTs. However, the report’s authors note that it may not be adequate to measure meaningful change in early-stage disease.

“Developing better tools certainly should be on the radar screen for all of us, because I think we can do better,” Dr. Petersen said. “The CDR, as good as it is and as long as it’s been used in the field, is a pretty blunt instrument, and it’s the result of subjective ratings.”
 

‘Quality of mind’

Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, said measuring the actual impact of a drug on a patient’s disease and quality of life has been a hot topic in the AD field for some time, but settling on a definition of “clinically meaningful” that everyone agrees upon will be a challenge.

“I think the idea of ‘clinically meaningful’ is truly a socially constructed idea,” said Dr. Karlawish, co-director of Penn’s Memory Center, who did not work on the report.

“You can come up with objective measures of cognition, but a measure to call something ‘clinically meaningful’ ultimately requires some sort of negotiated social order among clinicians and patients and others who have immediate interest in the health and well-being of the patient.”

Dr. Karlawish added that he’s interested in the conversations the report might prompt and the challenges it could highlight, especially when it comes to how meaningful clinical benefit can be measured, regardless of how it’s defined.

“Hidden in this conversation about clinically meaningful treatments in Alzheimer’s disease is, frankly, not quality of life, but quality of mind,” said Dr. Karlawish. “No measure captures acceptably the very thing that everyone actually cares a lot about and why we view this disease as so dreadful, which is damage to our mind.”
 

More evidence needed

The development of such tools will take time. What does that mean for drugs already in the pipeline? Members of the work group argue that those trials must move forward at the same time new tools are being created.

“We need to continue to refine, develop better instruments, [and] develop tools that are going to assess the disease in its more subtle features early on, even in the so-called ‘pre-symptomatic’ stage of the disease,” said lead author Dr. Petersen. “We shouldn’t wait for the development of that before intervening if we have a drug that seems to work.”

However, not everyone who agrees with the premise of the report agrees with this position, including Joel S. Perlmutter, MD, professor of neurology, Washington University School of Medicine, St. Louis, who also commented on the report.

As reported by this news organization, Dr. Perlmutter was one of three physicians who resigned from the FDA advisory panel that voted against approving aducanumab after the agency moved forward anyway.

“We have to be careful not to recommend DMTs that we hope will help without strong evidence, especially when potential side effects are not trivial,” Dr. Perlmutter said. “We have to have evidence before making these recommendations so we don’t end up harming people more than helping them.”

The report received no specific funding. Dr. Petersen received consulting fees from Roche, Nestle, Merck, Biogen, Eisai, and Genentech. Full disclosures are included in the original article. Dr. Perlmutter and Dr. Karlawish report no relevant financial relationships.

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

Slowing progression of, rather than stopping, Alzheimer’s disease (AD) has measurable benefits for patients and families and may be a more realistic goal for clinical AD drug trials, a new report suggests.

The report is a yearlong undertaking by an expert work group convened by the Alzheimer’s Association and was prompted, in part, by the fallout from the U.S. Food and Drug Administration’s controversial decision to grant aducanumab (Aduhelm) accelerated approval, which came over the objection of an advisory panel that found the drug was ineffective.

The report’s authors call for a “reframing” of how researchers define “clinically meaningful” in randomized controlled trials (RCTs), noting that it’s time to adjust expectations of outcomes from relatively short clinical trials.

“Without lowering the bar, are we expecting too much from a clinical trial by expecting that unless the disease is halted in its tracks and there’s no progression, we failed at treatment?” the report’s lead author and group leader Ronald C. Petersen, MD, PhD, lead author, chair of the work group, and professor of neurology at the Mayo Clinic, Rochester, Minn., told this news organization.

Interpretations of clinical meaningfulness are used in the drug approval process and in decisions about whether an insurer will cover the cost of treatment, the authors note.

While the report doesn’t provide a consensus definition of clinically meaningful benefit, it does offer a starting point for a conversation about how the phrase should be defined in the context of RCTs for disease-modifying therapies (DMTs) in AD, Dr. Petersen said.

“What we tried to do was to put it into some kind of perspective and at least have people reflect on this: If you’re going to design the perfect drug trial in Alzheimer’s disease, what would it be? We wanted to get people to think about it without digging in their heels for or against,” he added.

The report was published online  in Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association.
 

A proactive measure

The expert group began its work in January 2022, less than a year after the FDA approved aducanumab. Since the panel began its work, the FDA has approved a second AD drug, lecanemab (Leqembi), and denied accelerated approval of a third medication, donanemab.

“At the time we started this group, we had one approved treatment, and we just knew that there were others on the way, and we needed to be prepared to have this conversation and be more proactive than reactive,” Christopher Weber, PhD, director of global science initiatives for the Alzheimer’s Association and co-author of the report, said in an interview.

The work group suggests that simply slowing disease progression might be a desired goal for drug trials, especially early on, before cognition and memory are affected.

They also note that a benefit identified during an 18-month clinical trial may ultimately lead to even more meaningful changes over coming years, well beyond the trial’s end.

In addition, the report authors call for the development of better research tools to more accurately assess meaningful change. The Clinical Dementia Rating (CDR) scale is currently the key instrument used as a primary outcome measure in RCTs. However, the report’s authors note that it may not be adequate to measure meaningful change in early-stage disease.

“Developing better tools certainly should be on the radar screen for all of us, because I think we can do better,” Dr. Petersen said. “The CDR, as good as it is and as long as it’s been used in the field, is a pretty blunt instrument, and it’s the result of subjective ratings.”
 

‘Quality of mind’

Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, said measuring the actual impact of a drug on a patient’s disease and quality of life has been a hot topic in the AD field for some time, but settling on a definition of “clinically meaningful” that everyone agrees upon will be a challenge.

“I think the idea of ‘clinically meaningful’ is truly a socially constructed idea,” said Dr. Karlawish, co-director of Penn’s Memory Center, who did not work on the report.

“You can come up with objective measures of cognition, but a measure to call something ‘clinically meaningful’ ultimately requires some sort of negotiated social order among clinicians and patients and others who have immediate interest in the health and well-being of the patient.”

Dr. Karlawish added that he’s interested in the conversations the report might prompt and the challenges it could highlight, especially when it comes to how meaningful clinical benefit can be measured, regardless of how it’s defined.

“Hidden in this conversation about clinically meaningful treatments in Alzheimer’s disease is, frankly, not quality of life, but quality of mind,” said Dr. Karlawish. “No measure captures acceptably the very thing that everyone actually cares a lot about and why we view this disease as so dreadful, which is damage to our mind.”
 

More evidence needed

The development of such tools will take time. What does that mean for drugs already in the pipeline? Members of the work group argue that those trials must move forward at the same time new tools are being created.

“We need to continue to refine, develop better instruments, [and] develop tools that are going to assess the disease in its more subtle features early on, even in the so-called ‘pre-symptomatic’ stage of the disease,” said lead author Dr. Petersen. “We shouldn’t wait for the development of that before intervening if we have a drug that seems to work.”

However, not everyone who agrees with the premise of the report agrees with this position, including Joel S. Perlmutter, MD, professor of neurology, Washington University School of Medicine, St. Louis, who also commented on the report.

As reported by this news organization, Dr. Perlmutter was one of three physicians who resigned from the FDA advisory panel that voted against approving aducanumab after the agency moved forward anyway.

“We have to be careful not to recommend DMTs that we hope will help without strong evidence, especially when potential side effects are not trivial,” Dr. Perlmutter said. “We have to have evidence before making these recommendations so we don’t end up harming people more than helping them.”

The report received no specific funding. Dr. Petersen received consulting fees from Roche, Nestle, Merck, Biogen, Eisai, and Genentech. Full disclosures are included in the original article. Dr. Perlmutter and Dr. Karlawish report no relevant financial relationships.

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

Slowing progression of, rather than stopping, Alzheimer’s disease (AD) has measurable benefits for patients and families and may be a more realistic goal for clinical AD drug trials, a new report suggests.

The report is a yearlong undertaking by an expert work group convened by the Alzheimer’s Association and was prompted, in part, by the fallout from the U.S. Food and Drug Administration’s controversial decision to grant aducanumab (Aduhelm) accelerated approval, which came over the objection of an advisory panel that found the drug was ineffective.

The report’s authors call for a “reframing” of how researchers define “clinically meaningful” in randomized controlled trials (RCTs), noting that it’s time to adjust expectations of outcomes from relatively short clinical trials.

“Without lowering the bar, are we expecting too much from a clinical trial by expecting that unless the disease is halted in its tracks and there’s no progression, we failed at treatment?” the report’s lead author and group leader Ronald C. Petersen, MD, PhD, lead author, chair of the work group, and professor of neurology at the Mayo Clinic, Rochester, Minn., told this news organization.

Interpretations of clinical meaningfulness are used in the drug approval process and in decisions about whether an insurer will cover the cost of treatment, the authors note.

While the report doesn’t provide a consensus definition of clinically meaningful benefit, it does offer a starting point for a conversation about how the phrase should be defined in the context of RCTs for disease-modifying therapies (DMTs) in AD, Dr. Petersen said.

“What we tried to do was to put it into some kind of perspective and at least have people reflect on this: If you’re going to design the perfect drug trial in Alzheimer’s disease, what would it be? We wanted to get people to think about it without digging in their heels for or against,” he added.

The report was published online  in Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association.
 

A proactive measure

The expert group began its work in January 2022, less than a year after the FDA approved aducanumab. Since the panel began its work, the FDA has approved a second AD drug, lecanemab (Leqembi), and denied accelerated approval of a third medication, donanemab.

“At the time we started this group, we had one approved treatment, and we just knew that there were others on the way, and we needed to be prepared to have this conversation and be more proactive than reactive,” Christopher Weber, PhD, director of global science initiatives for the Alzheimer’s Association and co-author of the report, said in an interview.

The work group suggests that simply slowing disease progression might be a desired goal for drug trials, especially early on, before cognition and memory are affected.

They also note that a benefit identified during an 18-month clinical trial may ultimately lead to even more meaningful changes over coming years, well beyond the trial’s end.

In addition, the report authors call for the development of better research tools to more accurately assess meaningful change. The Clinical Dementia Rating (CDR) scale is currently the key instrument used as a primary outcome measure in RCTs. However, the report’s authors note that it may not be adequate to measure meaningful change in early-stage disease.

“Developing better tools certainly should be on the radar screen for all of us, because I think we can do better,” Dr. Petersen said. “The CDR, as good as it is and as long as it’s been used in the field, is a pretty blunt instrument, and it’s the result of subjective ratings.”
 

‘Quality of mind’

Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, said measuring the actual impact of a drug on a patient’s disease and quality of life has been a hot topic in the AD field for some time, but settling on a definition of “clinically meaningful” that everyone agrees upon will be a challenge.

“I think the idea of ‘clinically meaningful’ is truly a socially constructed idea,” said Dr. Karlawish, co-director of Penn’s Memory Center, who did not work on the report.

“You can come up with objective measures of cognition, but a measure to call something ‘clinically meaningful’ ultimately requires some sort of negotiated social order among clinicians and patients and others who have immediate interest in the health and well-being of the patient.”

Dr. Karlawish added that he’s interested in the conversations the report might prompt and the challenges it could highlight, especially when it comes to how meaningful clinical benefit can be measured, regardless of how it’s defined.

“Hidden in this conversation about clinically meaningful treatments in Alzheimer’s disease is, frankly, not quality of life, but quality of mind,” said Dr. Karlawish. “No measure captures acceptably the very thing that everyone actually cares a lot about and why we view this disease as so dreadful, which is damage to our mind.”
 

More evidence needed

The development of such tools will take time. What does that mean for drugs already in the pipeline? Members of the work group argue that those trials must move forward at the same time new tools are being created.

“We need to continue to refine, develop better instruments, [and] develop tools that are going to assess the disease in its more subtle features early on, even in the so-called ‘pre-symptomatic’ stage of the disease,” said lead author Dr. Petersen. “We shouldn’t wait for the development of that before intervening if we have a drug that seems to work.”

However, not everyone who agrees with the premise of the report agrees with this position, including Joel S. Perlmutter, MD, professor of neurology, Washington University School of Medicine, St. Louis, who also commented on the report.

As reported by this news organization, Dr. Perlmutter was one of three physicians who resigned from the FDA advisory panel that voted against approving aducanumab after the agency moved forward anyway.

“We have to be careful not to recommend DMTs that we hope will help without strong evidence, especially when potential side effects are not trivial,” Dr. Perlmutter said. “We have to have evidence before making these recommendations so we don’t end up harming people more than helping them.”

The report received no specific funding. Dr. Petersen received consulting fees from Roche, Nestle, Merck, Biogen, Eisai, and Genentech. Full disclosures are included in the original article. Dr. Perlmutter and Dr. Karlawish report no relevant financial relationships.

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.

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.]

In a recent, tragic case, a newborn died from being crushed by its mother, who fell asleep from the fatigue of numerous hours of labor. The case has brought the issue of obstetric violence (OV) to the attention of the Italian media. OV is defined as neglect, physical abuse, or disrespect during childbirth, according to the World Health Organization. The WHO outlined fundamental actions to be taken at various levels for its prevention, especially by health care systems, in a 2014 position paper.

Gender-based abuse

Considered a form of gender-based abuse, OV was first described in Latin America in the early 2000s. It is widespread and is increasing in European countries.

From the scientific literature on the subject, OV seems to be strongly associated with a lack of communication between health care personnel and pregnant women. It appears to have more to do with authoritarian and paternalistic behavior than actual real-life medical issues. Actively involving women in decision-making regarding childbirth and postpartum care seems to reduce the incidence of OV. Pregnant women who are more involved appear to trust health care professionals more and are therefore less likely to report disrespectful and abusive behavior.

Estimates of the prevalence of OV vary, depending on the country, the childbirth facility, and its definition. In Italy, inspired by the web campaign “#Bastatacere: le madri hanno voce [#EnoughSilence: mothers have a voice],” in 2017, the Obstetric Violence Database (OVO) investigated perceptions of having been a victim of OV in a representative sample of Italian women aged 18-54 years who had at least one child.

In 2017, just over 20% of the women interviewed considered themselves victims of OV; 33% felt they had not received adequate care; and around 35% reported serious problems concerning privacy or trust. Following the treatment received, approximately 15% of the women decided not to return to the same health care facility, and 6% did not want to proceed with further pregnancies.

At the time of publication, the results sparked a debate among relevant medical associations (the Association of Obstetricians and Gynecologists of Italian Hospitals, the Italian Society of Gynecology and Obstetrics, and the Association of Italian University Gynecologists), which immediately recognized the importance of the topic and accepted an invitation for further discussion on physician-patient relationships. They expressed reservations concerning the methodologies used by the OVO for data collection, especially regarding the representativeness of the sample.
 

Lack of communication

“In general, women who claim to have suffered from obstetric violence do not do so because they have been denied an aspect of care but because they have had an overall experience that, for whatever reason, did not conform with their expectations,” said Irene Cetin, MD, PhD, professor of obstetrics and gynecology at the University of Milan and director of the obstetrics and gynecology unit of the Buzzi Hospital in Milan. “Following the OVO’s exposé, the Italian Society of Gynecology and Obstetrics also conducted a large-scale study throughout Italy on all women who had given birth within a 3-month period. That investigation painted a very different picture. It wasn’t the case that no instances of obstetric violence were found, but the results were more contained. This is a very delicate subject, given that every report that we receive in hospital is always valued and looked into in detail, and women come to speak to us about errors and things that were missed.”

She added, “Experience leads me to say that complaints about what happens in the delivery room are extremely rare. What we hear more of, but still not often, are problems experienced during days spent in hospital immediately after childbirth.” There are never enough resources, which is the reason behind most problems. “The real hardships are found in the wards,” continued Dr. Cetin, “where the midwife-to-bed ratio is one or two to 30, and therefore this is where it is more difficult to feel like you’re being listened to. With COVID-19, the situation has gotten even worse, even though in my hospital we have always guaranteed, not without struggle, the presence of the partner in the delivery room.”

Only relatively recently have women’s partners been allowed into the hospital. In addition, a number of services, such as having the right beds and giving the correct explanations and information on how to establish a relationship with the child, are now being offered. These steps are necessary to guarantee what is referred to as a “humanizing birth,” a process in which the woman is at the center of the experience and is the main protagonist of the birth.
 

Lack of resources

This trend also is observed at the systemic level, where there is a lack of organization and resources. Few staff members are in the ward, even fewer specialists are in the psychological field, and contact is almost nonexistent after discharge from many hospitals and in many regions across Italy. There are, however, some positive aspects and hope for the future. “Just think,” said Dr. Cetin, “of how degree courses in obstetrics have changed over time, with a large part of teaching and training now being centered around the emotional aspects of birth.” From the gynecologist’s side, “most of the problems have been inherited from the past,” said Dr. Cetin. “Let’s not forget that we have only recently been giving birth in hospital. The so-called medicalization of childbirth has been responsible for a decline in the death rate and morbidity rate of pregnant women, but initially, there was little interest or care in how women felt in this situation, including with regard to physical pain. Since the 1970s, with Leboyer from France and Miraglia from Italy [promoters of so-called sweet birth], a path was cleared for a different line of thought. For this reason, I believe that the situation will improve over time.

“To continuously improve physician-patient communication,” concluded Dr. Cetin, “it would perhaps be appropriate to make sure that, even in the preparatory phase, women are well aware of possible complications and of the necessary and rapid emergency procedures that must be implemented by health care personnel. This way, a trusting relationship could be maintained, and the perception of having suffered abuse due to not being involved in strictly medical decisions could be stemmed.”

This article was translated from Univadis Italy. A version of this article appeared on Medscape.com.

In a recent, tragic case, a newborn died from being crushed by its mother, who fell asleep from the fatigue of numerous hours of labor. The case has brought the issue of obstetric violence (OV) to the attention of the Italian media. OV is defined as neglect, physical abuse, or disrespect during childbirth, according to the World Health Organization. The WHO outlined fundamental actions to be taken at various levels for its prevention, especially by health care systems, in a 2014 position paper.

Gender-based abuse

Considered a form of gender-based abuse, OV was first described in Latin America in the early 2000s. It is widespread and is increasing in European countries.

From the scientific literature on the subject, OV seems to be strongly associated with a lack of communication between health care personnel and pregnant women. It appears to have more to do with authoritarian and paternalistic behavior than actual real-life medical issues. Actively involving women in decision-making regarding childbirth and postpartum care seems to reduce the incidence of OV. Pregnant women who are more involved appear to trust health care professionals more and are therefore less likely to report disrespectful and abusive behavior.

Estimates of the prevalence of OV vary, depending on the country, the childbirth facility, and its definition. In Italy, inspired by the web campaign “#Bastatacere: le madri hanno voce [#EnoughSilence: mothers have a voice],” in 2017, the Obstetric Violence Database (OVO) investigated perceptions of having been a victim of OV in a representative sample of Italian women aged 18-54 years who had at least one child.

In 2017, just over 20% of the women interviewed considered themselves victims of OV; 33% felt they had not received adequate care; and around 35% reported serious problems concerning privacy or trust. Following the treatment received, approximately 15% of the women decided not to return to the same health care facility, and 6% did not want to proceed with further pregnancies.

At the time of publication, the results sparked a debate among relevant medical associations (the Association of Obstetricians and Gynecologists of Italian Hospitals, the Italian Society of Gynecology and Obstetrics, and the Association of Italian University Gynecologists), which immediately recognized the importance of the topic and accepted an invitation for further discussion on physician-patient relationships. They expressed reservations concerning the methodologies used by the OVO for data collection, especially regarding the representativeness of the sample.
 

Lack of communication

“In general, women who claim to have suffered from obstetric violence do not do so because they have been denied an aspect of care but because they have had an overall experience that, for whatever reason, did not conform with their expectations,” said Irene Cetin, MD, PhD, professor of obstetrics and gynecology at the University of Milan and director of the obstetrics and gynecology unit of the Buzzi Hospital in Milan. “Following the OVO’s exposé, the Italian Society of Gynecology and Obstetrics also conducted a large-scale study throughout Italy on all women who had given birth within a 3-month period. That investigation painted a very different picture. It wasn’t the case that no instances of obstetric violence were found, but the results were more contained. This is a very delicate subject, given that every report that we receive in hospital is always valued and looked into in detail, and women come to speak to us about errors and things that were missed.”

She added, “Experience leads me to say that complaints about what happens in the delivery room are extremely rare. What we hear more of, but still not often, are problems experienced during days spent in hospital immediately after childbirth.” There are never enough resources, which is the reason behind most problems. “The real hardships are found in the wards,” continued Dr. Cetin, “where the midwife-to-bed ratio is one or two to 30, and therefore this is where it is more difficult to feel like you’re being listened to. With COVID-19, the situation has gotten even worse, even though in my hospital we have always guaranteed, not without struggle, the presence of the partner in the delivery room.”

Only relatively recently have women’s partners been allowed into the hospital. In addition, a number of services, such as having the right beds and giving the correct explanations and information on how to establish a relationship with the child, are now being offered. These steps are necessary to guarantee what is referred to as a “humanizing birth,” a process in which the woman is at the center of the experience and is the main protagonist of the birth.
 

Lack of resources

This trend also is observed at the systemic level, where there is a lack of organization and resources. Few staff members are in the ward, even fewer specialists are in the psychological field, and contact is almost nonexistent after discharge from many hospitals and in many regions across Italy. There are, however, some positive aspects and hope for the future. “Just think,” said Dr. Cetin, “of how degree courses in obstetrics have changed over time, with a large part of teaching and training now being centered around the emotional aspects of birth.” From the gynecologist’s side, “most of the problems have been inherited from the past,” said Dr. Cetin. “Let’s not forget that we have only recently been giving birth in hospital. The so-called medicalization of childbirth has been responsible for a decline in the death rate and morbidity rate of pregnant women, but initially, there was little interest or care in how women felt in this situation, including with regard to physical pain. Since the 1970s, with Leboyer from France and Miraglia from Italy [promoters of so-called sweet birth], a path was cleared for a different line of thought. For this reason, I believe that the situation will improve over time.

“To continuously improve physician-patient communication,” concluded Dr. Cetin, “it would perhaps be appropriate to make sure that, even in the preparatory phase, women are well aware of possible complications and of the necessary and rapid emergency procedures that must be implemented by health care personnel. This way, a trusting relationship could be maintained, and the perception of having suffered abuse due to not being involved in strictly medical decisions could be stemmed.”

This article was translated from Univadis Italy. A version of this article appeared on Medscape.com.

In a recent, tragic case, a newborn died from being crushed by its mother, who fell asleep from the fatigue of numerous hours of labor. The case has brought the issue of obstetric violence (OV) to the attention of the Italian media. OV is defined as neglect, physical abuse, or disrespect during childbirth, according to the World Health Organization. The WHO outlined fundamental actions to be taken at various levels for its prevention, especially by health care systems, in a 2014 position paper.

Gender-based abuse

Considered a form of gender-based abuse, OV was first described in Latin America in the early 2000s. It is widespread and is increasing in European countries.

From the scientific literature on the subject, OV seems to be strongly associated with a lack of communication between health care personnel and pregnant women. It appears to have more to do with authoritarian and paternalistic behavior than actual real-life medical issues. Actively involving women in decision-making regarding childbirth and postpartum care seems to reduce the incidence of OV. Pregnant women who are more involved appear to trust health care professionals more and are therefore less likely to report disrespectful and abusive behavior.

Estimates of the prevalence of OV vary, depending on the country, the childbirth facility, and its definition. In Italy, inspired by the web campaign “#Bastatacere: le madri hanno voce [#EnoughSilence: mothers have a voice],” in 2017, the Obstetric Violence Database (OVO) investigated perceptions of having been a victim of OV in a representative sample of Italian women aged 18-54 years who had at least one child.

In 2017, just over 20% of the women interviewed considered themselves victims of OV; 33% felt they had not received adequate care; and around 35% reported serious problems concerning privacy or trust. Following the treatment received, approximately 15% of the women decided not to return to the same health care facility, and 6% did not want to proceed with further pregnancies.

At the time of publication, the results sparked a debate among relevant medical associations (the Association of Obstetricians and Gynecologists of Italian Hospitals, the Italian Society of Gynecology and Obstetrics, and the Association of Italian University Gynecologists), which immediately recognized the importance of the topic and accepted an invitation for further discussion on physician-patient relationships. They expressed reservations concerning the methodologies used by the OVO for data collection, especially regarding the representativeness of the sample.
 

Lack of communication

“In general, women who claim to have suffered from obstetric violence do not do so because they have been denied an aspect of care but because they have had an overall experience that, for whatever reason, did not conform with their expectations,” said Irene Cetin, MD, PhD, professor of obstetrics and gynecology at the University of Milan and director of the obstetrics and gynecology unit of the Buzzi Hospital in Milan. “Following the OVO’s exposé, the Italian Society of Gynecology and Obstetrics also conducted a large-scale study throughout Italy on all women who had given birth within a 3-month period. That investigation painted a very different picture. It wasn’t the case that no instances of obstetric violence were found, but the results were more contained. This is a very delicate subject, given that every report that we receive in hospital is always valued and looked into in detail, and women come to speak to us about errors and things that were missed.”

She added, “Experience leads me to say that complaints about what happens in the delivery room are extremely rare. What we hear more of, but still not often, are problems experienced during days spent in hospital immediately after childbirth.” There are never enough resources, which is the reason behind most problems. “The real hardships are found in the wards,” continued Dr. Cetin, “where the midwife-to-bed ratio is one or two to 30, and therefore this is where it is more difficult to feel like you’re being listened to. With COVID-19, the situation has gotten even worse, even though in my hospital we have always guaranteed, not without struggle, the presence of the partner in the delivery room.”

Only relatively recently have women’s partners been allowed into the hospital. In addition, a number of services, such as having the right beds and giving the correct explanations and information on how to establish a relationship with the child, are now being offered. These steps are necessary to guarantee what is referred to as a “humanizing birth,” a process in which the woman is at the center of the experience and is the main protagonist of the birth.
 

Lack of resources

This trend also is observed at the systemic level, where there is a lack of organization and resources. Few staff members are in the ward, even fewer specialists are in the psychological field, and contact is almost nonexistent after discharge from many hospitals and in many regions across Italy. There are, however, some positive aspects and hope for the future. “Just think,” said Dr. Cetin, “of how degree courses in obstetrics have changed over time, with a large part of teaching and training now being centered around the emotional aspects of birth.” From the gynecologist’s side, “most of the problems have been inherited from the past,” said Dr. Cetin. “Let’s not forget that we have only recently been giving birth in hospital. The so-called medicalization of childbirth has been responsible for a decline in the death rate and morbidity rate of pregnant women, but initially, there was little interest or care in how women felt in this situation, including with regard to physical pain. Since the 1970s, with Leboyer from France and Miraglia from Italy [promoters of so-called sweet birth], a path was cleared for a different line of thought. For this reason, I believe that the situation will improve over time.

“To continuously improve physician-patient communication,” concluded Dr. Cetin, “it would perhaps be appropriate to make sure that, even in the preparatory phase, women are well aware of possible complications and of the necessary and rapid emergency procedures that must be implemented by health care personnel. This way, a trusting relationship could be maintained, and the perception of having suffered abuse due to not being involved in strictly medical decisions could be stemmed.”

This article was translated from Univadis Italy. A version of this article appeared on Medscape.com.