Ob.Gyn. News

Misinformation about the COVID-19 travels faster than the virus and complicates the job of doctors who are treating those infected and responding to concerns of their other patients.

An array of myths springing up around this disease can be found on the Internet. The main themes appear to be false narratives about the origin of the virus, the size of the outbreak in the United States and in other countries, the availability of cures and treatments, and ways to prevent infection. Widespread misinformation hampers public health efforts to control the disease outbreak, confuses the public, and requires medical professionals to spend time refuting myths and re-educating patients.

A group of infectious disease experts became so alarmed by the misinformation trend they published a statement in The Lancet decrying the spread of false statements being circulated by some media outlets. “The rapid, open, and transparent sharing of data on this outbreak is now being threatened by rumours and misinformation ... Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardise our global collaboration in the fight against this virus,” wrote Charles H. Calisher, PhD, of Colorado State University, Fort Collins, and colleagues.
 

What can physicians do to counter misinformation?

Pulmonologist and critical care physician Cedric “Jamie” Rutland, MD, who practices in Riverside, Calif., sees misinformation about the novel coronavirus every day at home and on the job. His patients worry that everyone who gets infected will die or end up in the ICU. His neighbors ask him to pilfer surgical masks to protect them from the false notion that Chinese people in their community posed some kind of COVID-19 risk.

As he pondered how to counter myths with facts, Dr. Rutland turned to an unusual resource: His 7-year-old daughter Amelia. He explained to her how COVID-19 works and found that she could easily understand the basics. Now, Dr. Rutland draws upon the lessons from chats with his daughter as he explains COVID-19 to his patient audience on his YouTube channel “Medicine Deconstructed.” Simplicity, but not too much simplicity, is key, he said. Dr. Rutland uses a visual aid – a rough drawing of a virus – and shows how inflammation and antibodies enter the picture after infection. “I just teach them that if you’re a healthy person, this is how the body works, and this is what the immune system will do,” he said. “For the most part, you can calm people down when you make time for education.”

What are best practices? In a series of interviews, specialists emphasized the importance of fact-finding, wide-ranging communication, and – perhaps most difficult of all – humility.

Dr. Rutland emphasizes thoughtful communication based on facts and humility when communicating to patients about this potential health risk. “A lot of people finish medical school and think, ‘Everyone should trust me because I’m the pulmonologist or the GI doc.’ That’s not how it works. You still have to earn people’s trust,” he said.
 

Make sure all staff get reliable information

Hospitals are scrambling to keep staff safe with up-to-date directives and debunk false narratives about the virus. Keeping all hospital staff informed with verified and authoritative facts about the coronavirus is a key objective of the Massachusetts General Hospital’s Center for Disaster Medicine. The Center’s coronavirus educational materials are distributed to all staffers from physicians to janitors. “These provide information that they need to understand the risks and keep themselves safe,” said Eileen Searle, PhD, the Biothreats Clinical Operations program manager in the CDM.

According to Dr. Searle, the hospital keeps a continually updated COVID-19 Frequently Asked Questions document in its internal computer system. All employees can access it, she said, and it’s updated to include questions as they come up.

Even valets and front-desk volunteers are encouraged to read the FAQ, she said, since “they’re the first people that family and patients are interacting with.” The document “gives them reassurance about delivering messages,” she said.
 

Use patience with your patients

Dr. Rutland urges colleagues to take the time to listen to patients and educate them. “Reduce the gap between you and them,” said Dr. Rutland, who treats patients in Orange and Riverside counties. “Take off your white coat, sit down, and talk to the person about their concerns.”

Boston cardiologist Haider Warraich, MD, of Brigham and Women’s Hospital, Boston, said it’s important to “put medical information into a greater human context.” For example, he has told patients that he’s still taking his daughter to school despite COVID-19 risks. “I take the information I provide and apply it to my own life,” he said.

Speak out on social media – but don’t fight

Should medical professionals speak out about COVID-19 misinformation via social media? It’s an individual decision, Dr. Warraich said, “but my sense is that it’s never been more important for physicians to be part of the fray and help quell the epidemic of misinformation that almost always follows any type of medial calamity.”

Dr. Rutland, vice president and founding member of the Association for Healthcare Social Media, cautioned that effective communication via social media requires care. Avoid confrontation, he advised. “Don’t call people stupid or say things like, ‘I went to medical school and I’m smarter than you.’ ”

Instead, he said, “it’s important to just state the facts: These are the people who are dying, these are the people who are getting infected.”

And, he added, remember to push the most important message of all: Wash your hands!
 

Public health organizations fight the ‘infodemic’

In a trend that hearkens back to the days of snake oil cures for all maladies, advertisements for fake treatments are popping up on the Internet and on other media.

Facebook and Amazon have acted to remove these ads but these messages continue to flood social media such as Twitter, WhatsApp, and other sites. Discussion groups on platforms such as Reddit continue to pump out misinformation about COVID-19. Conspiracy theories that link the virus to espionage and bioweapons are making the rounds on the Internet and talk radio. Wrong information about the effectiveness of non-N95 face masks to protect wearers against infection is widespread, leading to shortages for medical personnel and price gouging. Pernicious rumors about the effectiveness of substances such a vinegar, silver, garlic, lemon juice, and even vodka to disinfect hands and surfaces abound on the Internet. An especially dangerous stream of misinformation stigmatizes ethnic groups and individuals as sources of the infection.

The World Health Organization identified early in the COVID-19 outbreak the global wave of misinformation about the virus and dubbed the problem the “infodemic.” The WHO “Q & A” page on COVID-19 is updated frequently and addresses myths and rumors currently circulating.

According to the WHO website, the agency has reached out to social media players such as Facebook, Twitter, Instagram, LinkedIn, Pinterest, TikTok, and Weibo, the microblogging site in China. WHO has worked with these sites to curb the “infodemic” of misinformation and has used these sites for public education outreach on COVID-19. “Myth busting” infographics posted on a WHO web page are also reposted on major social media sites.

The CDC has followed with its own “frequently asked questions” page to address questions and rumors. State health agencies have put up COVID-19 pages to address public concerns and offer advice on prevention. The Maryland Department of Health web page directly addresses dangerous misinformation: “Do not stigmatize people of any specific ethnicities or racial background. Viruses do not target people from specific populations, ethnicities or racial backgrounds. Stay informed and seek information from reliable, official sources. Be wary of myths, rumors and misinformation circulating online and elsewhere. Health information shared through social media is frequently inaccurate, unless coming from an official, reliable source such as the CDC, MDH or local health departments.”

The Washington State Department of Health has taken a more assertive stance on stigma. The COVID-19 web page recommends to the public: “Show compassion and support for individuals and communities more closely impacted. Avoid stigmatizing people who are in quarantine. They are making the right choice for their communities. Do not make assumptions about someone’s health status based on their ethnicity, race or national origin.”
 

Misinformation about the COVID-19 travels faster than the virus and complicates the job of doctors who are treating those infected and responding to concerns of their other patients.

An array of myths springing up around this disease can be found on the Internet. The main themes appear to be false narratives about the origin of the virus, the size of the outbreak in the United States and in other countries, the availability of cures and treatments, and ways to prevent infection. Widespread misinformation hampers public health efforts to control the disease outbreak, confuses the public, and requires medical professionals to spend time refuting myths and re-educating patients.

A group of infectious disease experts became so alarmed by the misinformation trend they published a statement in The Lancet decrying the spread of false statements being circulated by some media outlets. “The rapid, open, and transparent sharing of data on this outbreak is now being threatened by rumours and misinformation ... Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardise our global collaboration in the fight against this virus,” wrote Charles H. Calisher, PhD, of Colorado State University, Fort Collins, and colleagues.
 

What can physicians do to counter misinformation?

Pulmonologist and critical care physician Cedric “Jamie” Rutland, MD, who practices in Riverside, Calif., sees misinformation about the novel coronavirus every day at home and on the job. His patients worry that everyone who gets infected will die or end up in the ICU. His neighbors ask him to pilfer surgical masks to protect them from the false notion that Chinese people in their community posed some kind of COVID-19 risk.

As he pondered how to counter myths with facts, Dr. Rutland turned to an unusual resource: His 7-year-old daughter Amelia. He explained to her how COVID-19 works and found that she could easily understand the basics. Now, Dr. Rutland draws upon the lessons from chats with his daughter as he explains COVID-19 to his patient audience on his YouTube channel “Medicine Deconstructed.” Simplicity, but not too much simplicity, is key, he said. Dr. Rutland uses a visual aid – a rough drawing of a virus – and shows how inflammation and antibodies enter the picture after infection. “I just teach them that if you’re a healthy person, this is how the body works, and this is what the immune system will do,” he said. “For the most part, you can calm people down when you make time for education.”

What are best practices? In a series of interviews, specialists emphasized the importance of fact-finding, wide-ranging communication, and – perhaps most difficult of all – humility.

Dr. Rutland emphasizes thoughtful communication based on facts and humility when communicating to patients about this potential health risk. “A lot of people finish medical school and think, ‘Everyone should trust me because I’m the pulmonologist or the GI doc.’ That’s not how it works. You still have to earn people’s trust,” he said.
 

Make sure all staff get reliable information

Hospitals are scrambling to keep staff safe with up-to-date directives and debunk false narratives about the virus. Keeping all hospital staff informed with verified and authoritative facts about the coronavirus is a key objective of the Massachusetts General Hospital’s Center for Disaster Medicine. The Center’s coronavirus educational materials are distributed to all staffers from physicians to janitors. “These provide information that they need to understand the risks and keep themselves safe,” said Eileen Searle, PhD, the Biothreats Clinical Operations program manager in the CDM.

According to Dr. Searle, the hospital keeps a continually updated COVID-19 Frequently Asked Questions document in its internal computer system. All employees can access it, she said, and it’s updated to include questions as they come up.

Even valets and front-desk volunteers are encouraged to read the FAQ, she said, since “they’re the first people that family and patients are interacting with.” The document “gives them reassurance about delivering messages,” she said.
 

Use patience with your patients

Dr. Rutland urges colleagues to take the time to listen to patients and educate them. “Reduce the gap between you and them,” said Dr. Rutland, who treats patients in Orange and Riverside counties. “Take off your white coat, sit down, and talk to the person about their concerns.”

Boston cardiologist Haider Warraich, MD, of Brigham and Women’s Hospital, Boston, said it’s important to “put medical information into a greater human context.” For example, he has told patients that he’s still taking his daughter to school despite COVID-19 risks. “I take the information I provide and apply it to my own life,” he said.

Speak out on social media – but don’t fight

Should medical professionals speak out about COVID-19 misinformation via social media? It’s an individual decision, Dr. Warraich said, “but my sense is that it’s never been more important for physicians to be part of the fray and help quell the epidemic of misinformation that almost always follows any type of medial calamity.”

Dr. Rutland, vice president and founding member of the Association for Healthcare Social Media, cautioned that effective communication via social media requires care. Avoid confrontation, he advised. “Don’t call people stupid or say things like, ‘I went to medical school and I’m smarter than you.’ ”

Instead, he said, “it’s important to just state the facts: These are the people who are dying, these are the people who are getting infected.”

And, he added, remember to push the most important message of all: Wash your hands!
 

Public health organizations fight the ‘infodemic’

In a trend that hearkens back to the days of snake oil cures for all maladies, advertisements for fake treatments are popping up on the Internet and on other media.

Facebook and Amazon have acted to remove these ads but these messages continue to flood social media such as Twitter, WhatsApp, and other sites. Discussion groups on platforms such as Reddit continue to pump out misinformation about COVID-19. Conspiracy theories that link the virus to espionage and bioweapons are making the rounds on the Internet and talk radio. Wrong information about the effectiveness of non-N95 face masks to protect wearers against infection is widespread, leading to shortages for medical personnel and price gouging. Pernicious rumors about the effectiveness of substances such a vinegar, silver, garlic, lemon juice, and even vodka to disinfect hands and surfaces abound on the Internet. An especially dangerous stream of misinformation stigmatizes ethnic groups and individuals as sources of the infection.

The World Health Organization identified early in the COVID-19 outbreak the global wave of misinformation about the virus and dubbed the problem the “infodemic.” The WHO “Q & A” page on COVID-19 is updated frequently and addresses myths and rumors currently circulating.

According to the WHO website, the agency has reached out to social media players such as Facebook, Twitter, Instagram, LinkedIn, Pinterest, TikTok, and Weibo, the microblogging site in China. WHO has worked with these sites to curb the “infodemic” of misinformation and has used these sites for public education outreach on COVID-19. “Myth busting” infographics posted on a WHO web page are also reposted on major social media sites.

The CDC has followed with its own “frequently asked questions” page to address questions and rumors. State health agencies have put up COVID-19 pages to address public concerns and offer advice on prevention. The Maryland Department of Health web page directly addresses dangerous misinformation: “Do not stigmatize people of any specific ethnicities or racial background. Viruses do not target people from specific populations, ethnicities or racial backgrounds. Stay informed and seek information from reliable, official sources. Be wary of myths, rumors and misinformation circulating online and elsewhere. Health information shared through social media is frequently inaccurate, unless coming from an official, reliable source such as the CDC, MDH or local health departments.”

The Washington State Department of Health has taken a more assertive stance on stigma. The COVID-19 web page recommends to the public: “Show compassion and support for individuals and communities more closely impacted. Avoid stigmatizing people who are in quarantine. They are making the right choice for their communities. Do not make assumptions about someone’s health status based on their ethnicity, race or national origin.”
 

Misinformation about the COVID-19 travels faster than the virus and complicates the job of doctors who are treating those infected and responding to concerns of their other patients.

An array of myths springing up around this disease can be found on the Internet. The main themes appear to be false narratives about the origin of the virus, the size of the outbreak in the United States and in other countries, the availability of cures and treatments, and ways to prevent infection. Widespread misinformation hampers public health efforts to control the disease outbreak, confuses the public, and requires medical professionals to spend time refuting myths and re-educating patients.

A group of infectious disease experts became so alarmed by the misinformation trend they published a statement in The Lancet decrying the spread of false statements being circulated by some media outlets. “The rapid, open, and transparent sharing of data on this outbreak is now being threatened by rumours and misinformation ... Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardise our global collaboration in the fight against this virus,” wrote Charles H. Calisher, PhD, of Colorado State University, Fort Collins, and colleagues.
 

What can physicians do to counter misinformation?

Pulmonologist and critical care physician Cedric “Jamie” Rutland, MD, who practices in Riverside, Calif., sees misinformation about the novel coronavirus every day at home and on the job. His patients worry that everyone who gets infected will die or end up in the ICU. His neighbors ask him to pilfer surgical masks to protect them from the false notion that Chinese people in their community posed some kind of COVID-19 risk.

As he pondered how to counter myths with facts, Dr. Rutland turned to an unusual resource: His 7-year-old daughter Amelia. He explained to her how COVID-19 works and found that she could easily understand the basics. Now, Dr. Rutland draws upon the lessons from chats with his daughter as he explains COVID-19 to his patient audience on his YouTube channel “Medicine Deconstructed.” Simplicity, but not too much simplicity, is key, he said. Dr. Rutland uses a visual aid – a rough drawing of a virus – and shows how inflammation and antibodies enter the picture after infection. “I just teach them that if you’re a healthy person, this is how the body works, and this is what the immune system will do,” he said. “For the most part, you can calm people down when you make time for education.”

What are best practices? In a series of interviews, specialists emphasized the importance of fact-finding, wide-ranging communication, and – perhaps most difficult of all – humility.

Dr. Rutland emphasizes thoughtful communication based on facts and humility when communicating to patients about this potential health risk. “A lot of people finish medical school and think, ‘Everyone should trust me because I’m the pulmonologist or the GI doc.’ That’s not how it works. You still have to earn people’s trust,” he said.
 

Make sure all staff get reliable information

Hospitals are scrambling to keep staff safe with up-to-date directives and debunk false narratives about the virus. Keeping all hospital staff informed with verified and authoritative facts about the coronavirus is a key objective of the Massachusetts General Hospital’s Center for Disaster Medicine. The Center’s coronavirus educational materials are distributed to all staffers from physicians to janitors. “These provide information that they need to understand the risks and keep themselves safe,” said Eileen Searle, PhD, the Biothreats Clinical Operations program manager in the CDM.

According to Dr. Searle, the hospital keeps a continually updated COVID-19 Frequently Asked Questions document in its internal computer system. All employees can access it, she said, and it’s updated to include questions as they come up.

Even valets and front-desk volunteers are encouraged to read the FAQ, she said, since “they’re the first people that family and patients are interacting with.” The document “gives them reassurance about delivering messages,” she said.
 

Use patience with your patients

Dr. Rutland urges colleagues to take the time to listen to patients and educate them. “Reduce the gap between you and them,” said Dr. Rutland, who treats patients in Orange and Riverside counties. “Take off your white coat, sit down, and talk to the person about their concerns.”

Boston cardiologist Haider Warraich, MD, of Brigham and Women’s Hospital, Boston, said it’s important to “put medical information into a greater human context.” For example, he has told patients that he’s still taking his daughter to school despite COVID-19 risks. “I take the information I provide and apply it to my own life,” he said.

Speak out on social media – but don’t fight

Should medical professionals speak out about COVID-19 misinformation via social media? It’s an individual decision, Dr. Warraich said, “but my sense is that it’s never been more important for physicians to be part of the fray and help quell the epidemic of misinformation that almost always follows any type of medial calamity.”

Dr. Rutland, vice president and founding member of the Association for Healthcare Social Media, cautioned that effective communication via social media requires care. Avoid confrontation, he advised. “Don’t call people stupid or say things like, ‘I went to medical school and I’m smarter than you.’ ”

Instead, he said, “it’s important to just state the facts: These are the people who are dying, these are the people who are getting infected.”

And, he added, remember to push the most important message of all: Wash your hands!
 

Public health organizations fight the ‘infodemic’

In a trend that hearkens back to the days of snake oil cures for all maladies, advertisements for fake treatments are popping up on the Internet and on other media.

Facebook and Amazon have acted to remove these ads but these messages continue to flood social media such as Twitter, WhatsApp, and other sites. Discussion groups on platforms such as Reddit continue to pump out misinformation about COVID-19. Conspiracy theories that link the virus to espionage and bioweapons are making the rounds on the Internet and talk radio. Wrong information about the effectiveness of non-N95 face masks to protect wearers against infection is widespread, leading to shortages for medical personnel and price gouging. Pernicious rumors about the effectiveness of substances such a vinegar, silver, garlic, lemon juice, and even vodka to disinfect hands and surfaces abound on the Internet. An especially dangerous stream of misinformation stigmatizes ethnic groups and individuals as sources of the infection.

The World Health Organization identified early in the COVID-19 outbreak the global wave of misinformation about the virus and dubbed the problem the “infodemic.” The WHO “Q & A” page on COVID-19 is updated frequently and addresses myths and rumors currently circulating.

According to the WHO website, the agency has reached out to social media players such as Facebook, Twitter, Instagram, LinkedIn, Pinterest, TikTok, and Weibo, the microblogging site in China. WHO has worked with these sites to curb the “infodemic” of misinformation and has used these sites for public education outreach on COVID-19. “Myth busting” infographics posted on a WHO web page are also reposted on major social media sites.

The CDC has followed with its own “frequently asked questions” page to address questions and rumors. State health agencies have put up COVID-19 pages to address public concerns and offer advice on prevention. The Maryland Department of Health web page directly addresses dangerous misinformation: “Do not stigmatize people of any specific ethnicities or racial background. Viruses do not target people from specific populations, ethnicities or racial backgrounds. Stay informed and seek information from reliable, official sources. Be wary of myths, rumors and misinformation circulating online and elsewhere. Health information shared through social media is frequently inaccurate, unless coming from an official, reliable source such as the CDC, MDH or local health departments.”

The Washington State Department of Health has taken a more assertive stance on stigma. The COVID-19 web page recommends to the public: “Show compassion and support for individuals and communities more closely impacted. Avoid stigmatizing people who are in quarantine. They are making the right choice for their communities. Do not make assumptions about someone’s health status based on their ethnicity, race or national origin.”
 

Fecal-oral transmission may be part of the COVID-19 clinical picture, according to two reports published in Gastroenterology. The researchers find that RNA and proteins from SARS-CoV-2, the viral cause of COVID-19, are shed in feces early in infection and persist after respiratory symptoms abate.

But the discovery is preliminary. “There is evidence of the virus in stool, but not evidence of infectious virus,” David A. Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine in Norfolk, told Medscape Medical News.

The findings are not entirely unexpected. Both of the coronaviruses behind SARS and MERS are shed in stool, Jinyang Gu, MD, from Shanghai Jiao Tong University School of Medicine in Shanghai, China, and colleagues, note in one of the newly published articles.

In addition, as COVID-19 spread beyond China, clinicians began noticing initial mild gastrointestinal (GI) symptoms in some patients, including diarrhea, nausea, vomiting, and abdominal pain, preceding the hallmark fever, dry cough, and dyspnea. The first patient diagnosed in the United States with COVID-19 reported having 2 days of nausea and vomiting, with viral RNA detected in fecal and respiratory specimens, according to an earlier report.

Gu and colleagues warn that initial investigations would likely have not considered cases that manifested initially only as mild gastrointestinal symptoms.

Although early reports indicated that only about 10% of people with COVID-19 have GI symptoms, it isn’t known whether some infected individuals have only GI symptoms, Johnson said.

The GI manifestations are consistent with the distribution of ACE2 receptors, which serve as entry points for SARS-CoV-2, as well as SARS-CoV-1, which causes SARS. The receptors are most abundant in the cell membranes of lung AT2 cells, as well as in enterocytes in the ileum and colon.

“Altogether, many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” Gu and colleagues conclude.

But Johnson cautions, “gastroenterologists are not the ones managing diagnosis of COVID-19. It is diagnosed as a respiratory illness, but we are seeing concomitant gastrointestinal shedding in stool and saliva, and GI symptoms.”
 

Samples From 73 Patients Studied

In the second article published, Fei Xiao, MD, of Sun Yat-sen University in Guangdong Province, China, and colleagues report detecting viral RNA in samples from the mouths, noses, throats, urine, and feces of 73 patients hospitalized during the first 2 weeks of February.

Of the 73 hospitalized patients, 39 (53.24%; 25 males and 14 females) had viral RNA in their feces, present from 1 to 12 days. Seventeen (23.29%) of the patients continued to have viral RNA in their stool after respiratory symptoms had improved.

One patient underwent endoscopy. There was no evidence of damage to the GI epithelium, but the clinicians detected slightly elevated levels of lymphocytes and plasma cells.

The researcher used laser scanning confocal microscopy to analyze samples taken during the endoscopy. They found evidence of both ACE2 receptors and viral nucleocapsid proteins in the gastric, duodenal, and rectal glandular epithelial cells.

Finding evidence of SARS-CoV-2 throughout the GI system, if not direct infectivity, suggests a fecal-oral route of transmission, the researchers conclude. “Our immunofluorescent data showed that ACE2 protein, a cell receptor for SARS-CoV-2, is abundantly expressed in the glandular cells of gastric, duodenal and rectal epithelia, supporting the entry of SARS-CoV-2 into the host cells.”

Detection of viral RNA at different time points in infection, they write, suggests that the virions are continually secreted and therefore likely infectious, which is under investigation. “Prevention of fecal-oral transmission should be taken into consideration to control the spread of the virus,” they write.

Current recommendations do not require that patients’ fecal samples be tested before being considered noninfectious. However, given their findings and evidence from other studies, Xiao and colleagues recommend that real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) testing of fecal samples be added to current protocols.

Johnson offers practical suggestions based on the “potty hygiene” suggestions he gives to patients dealing with fecal shedding in Clostridioides difficile infection.

“To combat the microaerosolization of C. diff spores, I have patients do a complete bacteriocidal washing out of the toilet bowl, as well as clean surface areas and especially toothbrushes.” Keeping the bowl closed when not in use is important too in preventing “fecal-oral transmission of remnants” of toilet contents, he adds.

The new papers add to other reports suggesting that virus-bearing droplets may reach people in various ways, Johnson said. “Maybe the virus isn’t only spread by a cough or a sneeze.”

The researchers and commentator have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Fecal-oral transmission may be part of the COVID-19 clinical picture, according to two reports published in Gastroenterology. The researchers find that RNA and proteins from SARS-CoV-2, the viral cause of COVID-19, are shed in feces early in infection and persist after respiratory symptoms abate.

But the discovery is preliminary. “There is evidence of the virus in stool, but not evidence of infectious virus,” David A. Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine in Norfolk, told Medscape Medical News.

The findings are not entirely unexpected. Both of the coronaviruses behind SARS and MERS are shed in stool, Jinyang Gu, MD, from Shanghai Jiao Tong University School of Medicine in Shanghai, China, and colleagues, note in one of the newly published articles.

In addition, as COVID-19 spread beyond China, clinicians began noticing initial mild gastrointestinal (GI) symptoms in some patients, including diarrhea, nausea, vomiting, and abdominal pain, preceding the hallmark fever, dry cough, and dyspnea. The first patient diagnosed in the United States with COVID-19 reported having 2 days of nausea and vomiting, with viral RNA detected in fecal and respiratory specimens, according to an earlier report.

Gu and colleagues warn that initial investigations would likely have not considered cases that manifested initially only as mild gastrointestinal symptoms.

Although early reports indicated that only about 10% of people with COVID-19 have GI symptoms, it isn’t known whether some infected individuals have only GI symptoms, Johnson said.

The GI manifestations are consistent with the distribution of ACE2 receptors, which serve as entry points for SARS-CoV-2, as well as SARS-CoV-1, which causes SARS. The receptors are most abundant in the cell membranes of lung AT2 cells, as well as in enterocytes in the ileum and colon.

“Altogether, many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” Gu and colleagues conclude.

But Johnson cautions, “gastroenterologists are not the ones managing diagnosis of COVID-19. It is diagnosed as a respiratory illness, but we are seeing concomitant gastrointestinal shedding in stool and saliva, and GI symptoms.”
 

Samples From 73 Patients Studied

In the second article published, Fei Xiao, MD, of Sun Yat-sen University in Guangdong Province, China, and colleagues report detecting viral RNA in samples from the mouths, noses, throats, urine, and feces of 73 patients hospitalized during the first 2 weeks of February.

Of the 73 hospitalized patients, 39 (53.24%; 25 males and 14 females) had viral RNA in their feces, present from 1 to 12 days. Seventeen (23.29%) of the patients continued to have viral RNA in their stool after respiratory symptoms had improved.

One patient underwent endoscopy. There was no evidence of damage to the GI epithelium, but the clinicians detected slightly elevated levels of lymphocytes and plasma cells.

The researcher used laser scanning confocal microscopy to analyze samples taken during the endoscopy. They found evidence of both ACE2 receptors and viral nucleocapsid proteins in the gastric, duodenal, and rectal glandular epithelial cells.

Finding evidence of SARS-CoV-2 throughout the GI system, if not direct infectivity, suggests a fecal-oral route of transmission, the researchers conclude. “Our immunofluorescent data showed that ACE2 protein, a cell receptor for SARS-CoV-2, is abundantly expressed in the glandular cells of gastric, duodenal and rectal epithelia, supporting the entry of SARS-CoV-2 into the host cells.”

Detection of viral RNA at different time points in infection, they write, suggests that the virions are continually secreted and therefore likely infectious, which is under investigation. “Prevention of fecal-oral transmission should be taken into consideration to control the spread of the virus,” they write.

Current recommendations do not require that patients’ fecal samples be tested before being considered noninfectious. However, given their findings and evidence from other studies, Xiao and colleagues recommend that real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) testing of fecal samples be added to current protocols.

Johnson offers practical suggestions based on the “potty hygiene” suggestions he gives to patients dealing with fecal shedding in Clostridioides difficile infection.

“To combat the microaerosolization of C. diff spores, I have patients do a complete bacteriocidal washing out of the toilet bowl, as well as clean surface areas and especially toothbrushes.” Keeping the bowl closed when not in use is important too in preventing “fecal-oral transmission of remnants” of toilet contents, he adds.

The new papers add to other reports suggesting that virus-bearing droplets may reach people in various ways, Johnson said. “Maybe the virus isn’t only spread by a cough or a sneeze.”

The researchers and commentator have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Fecal-oral transmission may be part of the COVID-19 clinical picture, according to two reports published in Gastroenterology. The researchers find that RNA and proteins from SARS-CoV-2, the viral cause of COVID-19, are shed in feces early in infection and persist after respiratory symptoms abate.

But the discovery is preliminary. “There is evidence of the virus in stool, but not evidence of infectious virus,” David A. Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine in Norfolk, told Medscape Medical News.

The findings are not entirely unexpected. Both of the coronaviruses behind SARS and MERS are shed in stool, Jinyang Gu, MD, from Shanghai Jiao Tong University School of Medicine in Shanghai, China, and colleagues, note in one of the newly published articles.

In addition, as COVID-19 spread beyond China, clinicians began noticing initial mild gastrointestinal (GI) symptoms in some patients, including diarrhea, nausea, vomiting, and abdominal pain, preceding the hallmark fever, dry cough, and dyspnea. The first patient diagnosed in the United States with COVID-19 reported having 2 days of nausea and vomiting, with viral RNA detected in fecal and respiratory specimens, according to an earlier report.

Gu and colleagues warn that initial investigations would likely have not considered cases that manifested initially only as mild gastrointestinal symptoms.

Although early reports indicated that only about 10% of people with COVID-19 have GI symptoms, it isn’t known whether some infected individuals have only GI symptoms, Johnson said.

The GI manifestations are consistent with the distribution of ACE2 receptors, which serve as entry points for SARS-CoV-2, as well as SARS-CoV-1, which causes SARS. The receptors are most abundant in the cell membranes of lung AT2 cells, as well as in enterocytes in the ileum and colon.

“Altogether, many efforts should be made to be alert on the initial digestive symptoms of COVID-19 for early detection, early diagnosis, early isolation and early intervention,” Gu and colleagues conclude.

But Johnson cautions, “gastroenterologists are not the ones managing diagnosis of COVID-19. It is diagnosed as a respiratory illness, but we are seeing concomitant gastrointestinal shedding in stool and saliva, and GI symptoms.”
 

Samples From 73 Patients Studied

In the second article published, Fei Xiao, MD, of Sun Yat-sen University in Guangdong Province, China, and colleagues report detecting viral RNA in samples from the mouths, noses, throats, urine, and feces of 73 patients hospitalized during the first 2 weeks of February.

Of the 73 hospitalized patients, 39 (53.24%; 25 males and 14 females) had viral RNA in their feces, present from 1 to 12 days. Seventeen (23.29%) of the patients continued to have viral RNA in their stool after respiratory symptoms had improved.

One patient underwent endoscopy. There was no evidence of damage to the GI epithelium, but the clinicians detected slightly elevated levels of lymphocytes and plasma cells.

The researcher used laser scanning confocal microscopy to analyze samples taken during the endoscopy. They found evidence of both ACE2 receptors and viral nucleocapsid proteins in the gastric, duodenal, and rectal glandular epithelial cells.

Finding evidence of SARS-CoV-2 throughout the GI system, if not direct infectivity, suggests a fecal-oral route of transmission, the researchers conclude. “Our immunofluorescent data showed that ACE2 protein, a cell receptor for SARS-CoV-2, is abundantly expressed in the glandular cells of gastric, duodenal and rectal epithelia, supporting the entry of SARS-CoV-2 into the host cells.”

Detection of viral RNA at different time points in infection, they write, suggests that the virions are continually secreted and therefore likely infectious, which is under investigation. “Prevention of fecal-oral transmission should be taken into consideration to control the spread of the virus,” they write.

Current recommendations do not require that patients’ fecal samples be tested before being considered noninfectious. However, given their findings and evidence from other studies, Xiao and colleagues recommend that real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) testing of fecal samples be added to current protocols.

Johnson offers practical suggestions based on the “potty hygiene” suggestions he gives to patients dealing with fecal shedding in Clostridioides difficile infection.

“To combat the microaerosolization of C. diff spores, I have patients do a complete bacteriocidal washing out of the toilet bowl, as well as clean surface areas and especially toothbrushes.” Keeping the bowl closed when not in use is important too in preventing “fecal-oral transmission of remnants” of toilet contents, he adds.

The new papers add to other reports suggesting that virus-bearing droplets may reach people in various ways, Johnson said. “Maybe the virus isn’t only spread by a cough or a sneeze.”

The researchers and commentator have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The World Health Organization has formally declared the COVID-19 outbreak a pandemic.

“WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction,” WHO Director-General Tedros Adhanom Ghebreyesus said during a March 11 press briefing. “We therefore made the assessment that COVID-19 can be characterized as a pandemic.”

He noted that this is the first time a coronavirus has been seen as a pandemic.

The Director-General cautioned that just looking at the number of countries affected, 114 countries, “does not tell the full story. ... We cannot say this loudly enough, or clearly enough, or often enough: All countries can still change the course of this pandemic.”

He reiterated the need for a whole-of-government and a whole-of-society approach to dealing with this, including taking precautions such as isolating, testing, and treating every case and tracing every contact, as well as readying hospitals and health care professionals.

“Let’s look out for each other, because we need each other,” he said.

gtwachtman@mdedge.com

The World Health Organization has formally declared the COVID-19 outbreak a pandemic.

“WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction,” WHO Director-General Tedros Adhanom Ghebreyesus said during a March 11 press briefing. “We therefore made the assessment that COVID-19 can be characterized as a pandemic.”

He noted that this is the first time a coronavirus has been seen as a pandemic.

The Director-General cautioned that just looking at the number of countries affected, 114 countries, “does not tell the full story. ... We cannot say this loudly enough, or clearly enough, or often enough: All countries can still change the course of this pandemic.”

He reiterated the need for a whole-of-government and a whole-of-society approach to dealing with this, including taking precautions such as isolating, testing, and treating every case and tracing every contact, as well as readying hospitals and health care professionals.

“Let’s look out for each other, because we need each other,” he said.

gtwachtman@mdedge.com

The World Health Organization has formally declared the COVID-19 outbreak a pandemic.

“WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction,” WHO Director-General Tedros Adhanom Ghebreyesus said during a March 11 press briefing. “We therefore made the assessment that COVID-19 can be characterized as a pandemic.”

He noted that this is the first time a coronavirus has been seen as a pandemic.

The Director-General cautioned that just looking at the number of countries affected, 114 countries, “does not tell the full story. ... We cannot say this loudly enough, or clearly enough, or often enough: All countries can still change the course of this pandemic.”

He reiterated the need for a whole-of-government and a whole-of-society approach to dealing with this, including taking precautions such as isolating, testing, and treating every case and tracing every contact, as well as readying hospitals and health care professionals.

“Let’s look out for each other, because we need each other,” he said.

gtwachtman@mdedge.com

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

aotto@mdedge.com

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

aotto@mdedge.com

The transmission rate of coronavirus disease 2019 (COVID-19) was 1%-5% among 38,000 Chinese people in close contact with infected patients, according to the chief epidemiologist of the Chinese Centers for Disease Control and Prevention, Beijing, Zunyou Wu, MD, PhD, who gave an update on the epidemic at the Conference on Retroviruses & Opportunistic Infections.

The rate of spread to family members – the driver of the infection in China – was 10% early in the outbreak, but fell to 3% with quicker recognition and isolation. The overall numbers are lower than might have been expected, and an important insight for clinicians trying to contain the outbreak in the United States.

Patients were most infectious at the onset of symptoms, when they spiked a fever and started coughing, but their ability to spread the infection dropped after that, Dr. Wu and others said at a special COVID-19 session at the meeting, which was scheduled to be in Boston, but was held online instead because of concerns about spreading the virus. The session has been posted.

Transmission from presymptomatic people is rare. Shedding persists to some degree for 7-12 days in mild/moderate cases, but 2 weeks or more in severe cases.

Dr. Wu said the numbers in China are moving in the right direction, which means that containment efforts there have worked.

The virus emerged in Wuhan, the capital of Hubei province in central China, in connection with a wildlife food market in December 2019. Bats are thought to be the reservoir, with perhaps an intermediate step between civet cats and raccoon dogs. Officials shut down the market.

Essentially, the entire population of China, more than a billion people, was told to stay home for 10 days to interrupt the transmission cycle after the virus spread throughout the country in a few weeks, and almost 60 million people in Hubei were put behind a cordon sanitaire, where they have been for 50 days and will remain “for a while,” Dr. Wu said.

It’s led to a steep drop in new cases and deaths in China since mid-February; both are now more common outside China than inside, and international numbers are lower than they were at the peak in China.

aotto@mdedge.com

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

gtwachtman@mdedge.com

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

gtwachtman@mdedge.com

Officials at the Food and Drug Administration’s Center for Drug Evaluation and Research are taking the precautionary step of canceling or postponing advisory committee meetings and limiting staff travel in an effort to help curb the spread of the COVID-19.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“The outbreak of respiratory illness caused by a novel coronavirus, COVID-19, that started in China is spreading to other countries, including the United States,” CDER Director Janet Woodcock, MD, said in a memo to CDER staff. “As a precaution, FDA is canceling foreign official agency travel and limiting domestic travel to mission critical only, effective immediately and through April.”

Additionally, the memo notes that “CDER-organized external meetings, conferences, and workshops will be postponed or canceled from March 10 through April.”

“To mitigate the impact on our work, I encourage you to hold meetings with external stakeholders through teleconference, when possible,” she wrote.

Thus far, only a few CDER events on the FDA’s meeting webpage are listed as being canceled or postponed. Some of the affected meetings include a March 10 public meeting on patient-focused drug development for stimulant-use disorder, a March 11 meeting of the Nonprescription Drug Advisory Committee, and a March 30 public meeting on patient-focused drug development for vitiligo, all of which are postponed until further notice. The Center for Biologics Evaluation and Research also has postponed until further notice its U.S.–Japan Cellular and Gene Therapy Conference, originally scheduled for March 12.

Dr. Woodcock also noted in the memo that in relation to inspections, “we plan to use technology and established agreements with our foreign counterparts to minimize disruptions to the drug supply chain and to applications under review, so that Americans can continue to get their medications.”

gtwachtman@mdedge.com

NATIONAL HARBOR, MD. – Botulinum toxin injection into the vagina appears to relieve pain associated with endometriosis by relaxing the pelvic floor muscles, new research suggests.

In a randomized study, women with surgically diagnosed endometriosis who had chronic pelvic pain despite optimal surgical and hormonal treatment had less pain after injection vs their counterparts who received placebo.

This result suggests pelvic floor spasm may be an important factor in endometriosis-associated pelvic pain, the investigators note.

“Botulinum toxin injection offers an alternative approach for women with pelvic pain,” lead author Barbara Illowsky Karp, MD, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Md., told Medscape Medical News.

“We focused on endometriosis, but there are reasons to think it may be effective for pelvic pain from other causes if there is spasm of the muscle,” said Karp, a neurologist who has used botulinum toxin therapeutically since it was first developed in the 1980s.

She noted that it is unknown whether the toxin will work in women who do not have actual spasm, “but the effect on spasm is not the sole effect of toxin,” as demonstrated by its use in other pain conditions.

“It seems to have a direct effect on the pain pathways in the nervous system as well,” Karp added.

The study findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
 

Less pain

The investigators randomly assigned 29 women between the ages of 18 and 50 years to receive injections with 100 U onabotulinumtoxinA (n = 15) or saline placebo (n = 14).

All of the women had endometriosis with chronic pelvic pain lasting at least 3 months (mean time, 6 years) and confirmed pelvic floor spasm as a main pain generator.

One month after treatment, participants were asked if they had improvement in their pain.

“Our primary outcome was just simply asking the women if they felt better or not, because we were blinded as to what treatment they received. One month is typically when the toxin reaches its maximal effect,” Karp said.

At 1 month, 11 women in the placebo group reported that they had no benefit, compared with only 4 women in the botulinum toxin group (P = .027).

The botulinum toxin group reported a greater degree of benefit compared with the placebo group (P = .030) and greater percent of improvement (P = .034).

Neither group reported substantial changes in pain rating on the visual analog scale. However, a definite pain score is often difficult to measure in women with chronic pelvic pain, coinvestigator Pamela Stratton, MD, a gynecologist in Bethesda, said.

“Some women report their pain as a 2, some as an 8. Also, women may have a lot of pain one day and not have that much pain another day, and how do you measure that? This is why we have not focused solely on the pain score but instead wanted the women to tell us if they were improved or not,” Stratton told Medscape Medical News.

Disability worsened considerably in the placebo group, but remained consistent in the botulinum toxin group. Five patients in the botulinum toxin group were able to reduce pain medication compared with one patient in the placebo group.
 

“Compelling” findings but early days

Commenting on the findings for Medscape Medical News, Ann E. Hansen, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, noted that this “preliminary study” showed some benefit for a complex and challenging-to-treat syndrome.

“Injection of botulinum toxin prevents local muscle contraction, thus effectively relieving a variety of neuromuscular conditions such as torticollis; spasticity; pain syndromes such as headache and migraine; and some neurologic disorders, for instance, overactive bladder,” said Hansen, who was not involved with the research.

“Using botulinum toxin injection to target pelvic floor muscle spasm, a known pain generator in women suffering from chronic pelvic pain, makes sense. Future studies will be helpful in elucidating optimal treatment protocols for this debilitating condition,” she added.

Also commenting for Medscape Medical News, Kathryn T. Hall, PhD, MPH, Brigham & Women’s Hospital, Boston, Massachusetts, called the results “quite compelling” although, “it’s still early days.”

“It remains to be seen if the treatment effect will endure or if side effects will emerge. Hopefully all will go well,” Hall said.

The study was funded by an unrestricted grant from the National Institutes of Health. Allergan provided the botulinum toxin that was used in the study. Karp, Stratton, Hansen, and Hall have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

NATIONAL HARBOR, MD. – Botulinum toxin injection into the vagina appears to relieve pain associated with endometriosis by relaxing the pelvic floor muscles, new research suggests.

In a randomized study, women with surgically diagnosed endometriosis who had chronic pelvic pain despite optimal surgical and hormonal treatment had less pain after injection vs their counterparts who received placebo.

This result suggests pelvic floor spasm may be an important factor in endometriosis-associated pelvic pain, the investigators note.

“Botulinum toxin injection offers an alternative approach for women with pelvic pain,” lead author Barbara Illowsky Karp, MD, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Md., told Medscape Medical News.

“We focused on endometriosis, but there are reasons to think it may be effective for pelvic pain from other causes if there is spasm of the muscle,” said Karp, a neurologist who has used botulinum toxin therapeutically since it was first developed in the 1980s.

She noted that it is unknown whether the toxin will work in women who do not have actual spasm, “but the effect on spasm is not the sole effect of toxin,” as demonstrated by its use in other pain conditions.

“It seems to have a direct effect on the pain pathways in the nervous system as well,” Karp added.

The study findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
 

Less pain

The investigators randomly assigned 29 women between the ages of 18 and 50 years to receive injections with 100 U onabotulinumtoxinA (n = 15) or saline placebo (n = 14).

All of the women had endometriosis with chronic pelvic pain lasting at least 3 months (mean time, 6 years) and confirmed pelvic floor spasm as a main pain generator.

One month after treatment, participants were asked if they had improvement in their pain.

“Our primary outcome was just simply asking the women if they felt better or not, because we were blinded as to what treatment they received. One month is typically when the toxin reaches its maximal effect,” Karp said.

At 1 month, 11 women in the placebo group reported that they had no benefit, compared with only 4 women in the botulinum toxin group (P = .027).

The botulinum toxin group reported a greater degree of benefit compared with the placebo group (P = .030) and greater percent of improvement (P = .034).

Neither group reported substantial changes in pain rating on the visual analog scale. However, a definite pain score is often difficult to measure in women with chronic pelvic pain, coinvestigator Pamela Stratton, MD, a gynecologist in Bethesda, said.

“Some women report their pain as a 2, some as an 8. Also, women may have a lot of pain one day and not have that much pain another day, and how do you measure that? This is why we have not focused solely on the pain score but instead wanted the women to tell us if they were improved or not,” Stratton told Medscape Medical News.

Disability worsened considerably in the placebo group, but remained consistent in the botulinum toxin group. Five patients in the botulinum toxin group were able to reduce pain medication compared with one patient in the placebo group.
 

“Compelling” findings but early days

Commenting on the findings for Medscape Medical News, Ann E. Hansen, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, noted that this “preliminary study” showed some benefit for a complex and challenging-to-treat syndrome.

“Injection of botulinum toxin prevents local muscle contraction, thus effectively relieving a variety of neuromuscular conditions such as torticollis; spasticity; pain syndromes such as headache and migraine; and some neurologic disorders, for instance, overactive bladder,” said Hansen, who was not involved with the research.

“Using botulinum toxin injection to target pelvic floor muscle spasm, a known pain generator in women suffering from chronic pelvic pain, makes sense. Future studies will be helpful in elucidating optimal treatment protocols for this debilitating condition,” she added.

Also commenting for Medscape Medical News, Kathryn T. Hall, PhD, MPH, Brigham & Women’s Hospital, Boston, Massachusetts, called the results “quite compelling” although, “it’s still early days.”

“It remains to be seen if the treatment effect will endure or if side effects will emerge. Hopefully all will go well,” Hall said.

The study was funded by an unrestricted grant from the National Institutes of Health. Allergan provided the botulinum toxin that was used in the study. Karp, Stratton, Hansen, and Hall have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

NATIONAL HARBOR, MD. – Botulinum toxin injection into the vagina appears to relieve pain associated with endometriosis by relaxing the pelvic floor muscles, new research suggests.

In a randomized study, women with surgically diagnosed endometriosis who had chronic pelvic pain despite optimal surgical and hormonal treatment had less pain after injection vs their counterparts who received placebo.

This result suggests pelvic floor spasm may be an important factor in endometriosis-associated pelvic pain, the investigators note.

“Botulinum toxin injection offers an alternative approach for women with pelvic pain,” lead author Barbara Illowsky Karp, MD, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Md., told Medscape Medical News.

“We focused on endometriosis, but there are reasons to think it may be effective for pelvic pain from other causes if there is spasm of the muscle,” said Karp, a neurologist who has used botulinum toxin therapeutically since it was first developed in the 1980s.

She noted that it is unknown whether the toxin will work in women who do not have actual spasm, “but the effect on spasm is not the sole effect of toxin,” as demonstrated by its use in other pain conditions.

“It seems to have a direct effect on the pain pathways in the nervous system as well,” Karp added.

The study findings were presented here at the American Academy of Pain Medicine (AAPM) 2020 Annual Meeting.
 

Less pain

The investigators randomly assigned 29 women between the ages of 18 and 50 years to receive injections with 100 U onabotulinumtoxinA (n = 15) or saline placebo (n = 14).

All of the women had endometriosis with chronic pelvic pain lasting at least 3 months (mean time, 6 years) and confirmed pelvic floor spasm as a main pain generator.

One month after treatment, participants were asked if they had improvement in their pain.

“Our primary outcome was just simply asking the women if they felt better or not, because we were blinded as to what treatment they received. One month is typically when the toxin reaches its maximal effect,” Karp said.

At 1 month, 11 women in the placebo group reported that they had no benefit, compared with only 4 women in the botulinum toxin group (P = .027).

The botulinum toxin group reported a greater degree of benefit compared with the placebo group (P = .030) and greater percent of improvement (P = .034).

Neither group reported substantial changes in pain rating on the visual analog scale. However, a definite pain score is often difficult to measure in women with chronic pelvic pain, coinvestigator Pamela Stratton, MD, a gynecologist in Bethesda, said.

“Some women report their pain as a 2, some as an 8. Also, women may have a lot of pain one day and not have that much pain another day, and how do you measure that? This is why we have not focused solely on the pain score but instead wanted the women to tell us if they were improved or not,” Stratton told Medscape Medical News.

Disability worsened considerably in the placebo group, but remained consistent in the botulinum toxin group. Five patients in the botulinum toxin group were able to reduce pain medication compared with one patient in the placebo group.
 

“Compelling” findings but early days

Commenting on the findings for Medscape Medical News, Ann E. Hansen, MD, Chronic Pain Wellness Center, Phoenix VA Health Care System, Arizona, noted that this “preliminary study” showed some benefit for a complex and challenging-to-treat syndrome.

“Injection of botulinum toxin prevents local muscle contraction, thus effectively relieving a variety of neuromuscular conditions such as torticollis; spasticity; pain syndromes such as headache and migraine; and some neurologic disorders, for instance, overactive bladder,” said Hansen, who was not involved with the research.

“Using botulinum toxin injection to target pelvic floor muscle spasm, a known pain generator in women suffering from chronic pelvic pain, makes sense. Future studies will be helpful in elucidating optimal treatment protocols for this debilitating condition,” she added.

Also commenting for Medscape Medical News, Kathryn T. Hall, PhD, MPH, Brigham & Women’s Hospital, Boston, Massachusetts, called the results “quite compelling” although, “it’s still early days.”

“It remains to be seen if the treatment effect will endure or if side effects will emerge. Hopefully all will go well,” Hall said.

The study was funded by an unrestricted grant from the National Institutes of Health. Allergan provided the botulinum toxin that was used in the study. Karp, Stratton, Hansen, and Hall have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

koakes@mdedge.com

SOURCE: Jao J et al. CROI 2020, Poster 00772.

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

koakes@mdedge.com

SOURCE: Jao J et al. CROI 2020, Poster 00772.

Women with HIV on dolutegravir-based antiretroviral therapy (ART) protocols had higher weights through 18 months of the postpartum period than women on efavirenz-based therapy, according to a recent study. However, women taking dolutegravir had similar postpartum weights to women who did not have HIV infection.

The results were shared by Jennifer Jao, MD, MPH, of Northwestern University, Chicago, in a video presentation of the research during the Conference on Retroviruses & Opportunistic Infections, which was presented online this year. CROI organizers chose to hold a virtual meeting because of concerns about the spread of COVID-19.

Dr. Jao, an internal medicine physician and pediatrician, and colleagues looked at the association between dolutegravir and postpartum weight for women with HIV, compared with women with HIV who were taking efavirenz-based ART and women who did not have HIV infection.

Though there was no significant difference among the three groups for body mass index at 4 weeks post partum (all were between 24 and 26 kg/m²), postpartum weight for the dolutegravir group was significantly higher.

Using a mixed models statistical approach that adjusted for potentially confounding variables, Dr. Jao and associates found that women on a dolutegravir-based regiment weighed an average of 5 kg more postpartum than women on an efavirenz-based regiment. (P less than .01).

Further adjustment that included CD4 count, viral load, and ART status at conception didn’t change the results from the original approach that included such variables as age, breastfeeding duration , gestational diabetes status, and second and third trimester weight gain (P = .04).

The study was a secondary analysis of the Tshilo Dikotla study conducted in Botswana. Dr. Jao said that the study addressed the known association of dolutegravir-based ART with higher weight gain than other ART regimens. Seeing how postpartum weight varies by regimen is important because “postpartum weight retention impacts cardiometabolic risk,” added Dr. Jao.

Of a total of 406 women, 170 were on dolutegravir-based therapy, 114 were on efavirenz-based therapy, and 122 weren’t HIV infected. Overall, the women on efavirenz-based therapy were older, with a median age of 33 years, compared with 28.5 and 25 years for the dolutegravir group and those without HIV, respectively. This and all other between-group differences were statistically significant at P less than .01.

Women without HIV had lower gravidity, with a median one pregnancy, compared with three in the other two groups. Other significant differences included a higher rate of weight gain in the second and third trimesters for the non–HIV-infected group, who gained at a rate of 0.3 kg/week, compared with 0.1 and 0.2 kg/week for the efavirenz and dolutegravir groups, respectively. Breastfeeding duration was longer in the non–HIV-infected group as well.

Finally, 86% of women on efavirenz-based therapy were on ART at the time of conception, compared with just 35.3% of women on dolutegravir-based treatment.

“Further studies to assess mechanisms of postpartum weight retention are needed,” said Dr. Jao.

The study was supported by the National Institutes of Health. Dr. Jao reported no relevant conflicts of interest.

koakes@mdedge.com

SOURCE: Jao J et al. CROI 2020, Poster 00772.

The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.

AndreyPopov/ThinkStock

Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.

During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.

“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”

Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.

“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”

During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”

Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.

“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”

Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.

Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.

During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.

“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.

The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.

“We’re not going to solve this at oral argument,” he said.

A decision by the Supreme Court is expected by August 2020.

agallegos@mdedge.com

The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.

AndreyPopov/ThinkStock

Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.

During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.

“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”

Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.

“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”

During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”

Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.

“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”

Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.

Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.

During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.

“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.

The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.

“We’re not going to solve this at oral argument,” he said.

A decision by the Supreme Court is expected by August 2020.

agallegos@mdedge.com

The U.S. Supreme Court will likely decide by the end of the summer whether a controversial Louisiana abortion law that imposes restrictions on physicians can stand.

AndreyPopov/ThinkStock

Justices heard oral arguments March 4, 2020, in June Medicare Services v. Russo, which centers on a Louisiana law requiring physicians who perform abortions to have admitting privileges at a nearby hospital. Doctors who perform abortions without admitting privileges at a hospital within 30 miles face fines and imprisonment, while clinics that violate the law can have their licenses revoked, according to the state law, originally passed in 2014. In 2016, the Supreme Court in 2016 heard a similar case – Whole Woman’s Health v. Hellerstedt – concerning a comparable law in Texas. In that case, the justices struck down the measure as unconstitutional.

During oral arguments, Julie Rikelman an attorney representing June Medical Services, said that the Louisiana law is identical to the abortion law in Texas, and she argued that justices should reach the same conclusion.

“The district court found this law would leave Louisiana with just one clinic in one state to serve about 10,000 people per year,” Ms. Rikelman said during oral arguments. “That would mean that hundreds of thousands of women would now live more than 150 miles from the closest provider. And the burdens were actually more severe than this court found in Whole Woman’s Health.”

Elizabeth Murrill, solicitor general of Louisiana, argued that the Louisiana law was justified, and that the 5th U.S. Circuit Court of Appeals was correct when it reversed a district court decision and upheld the law.

“The 5th Circuit correctly held that the plaintiffs in this case failed to carry their burden – their heavy burden of proof that is required to facially invalidate a state law,” Ms. Murrill said during oral arguments. “Louisiana’s decision to require abortion providers to have admitting privileges was justified by abundant evidence of life-threatening health and safety violations, malpractice, noncompliance with professional licensing rules, legislative testimony from postabortive women, [and] testimony from doctors who took care of abortion providers’ abandoned patients.”

During arguments, Justice Ruth Bader Ginsburg questioned the reasoning behind the 30-mile privileges rule, expressing doubt at the state’s justification for the requirement. “What sense does the 30-mile limit make, considering that – certainly for medication abortions and for the overwhelming number of other abortions ... if the woman has a problem, it will be her local hospital that ... she will need to go to for the care, not something 30 miles from the clinic.”

Ms. Murrill responded that the Louisiana regulation is consistent with surgery and ambulatory surgery regulations and aligns with the state’s regulatory structure.

“We had evidence in the record of women who did require transfers,” Ms. Murrill said. “[An abortion provider] testified unambiguously that he had to transfer four patients who had punctured uteruses and were hemorrhaging.”

Whether the plaintiffs have standing to sue is a key question. As a general rule, a plaintiff can only sue to protect their own rights, unless the plaintiff has a close relationship with a third party and there are barriers that prevent the third party from suing. Attorneys for Louisiana contend that the plaintiffs – the medical clinic and several physicians – have no right to sue because their rights are not at stake, and that there is no obstacle to patients suing over the law.

Since the Louisiana law is intended to protect women from “unscrupulous and incompetent abortion providers,” the state argues also that there is a conflict of interest between the physicians and the patients on whose behalf they are suing.

During arguments, Justice Samuel Alito Jr. repeatedly questioned Ms. Rikelman on the plaintiffs’ right to sue, conveying doubt that the plaintiffs were on solid legal ground.

“Would you agree with the general proposition that a party should not be able to sue ostensibly to protect the rights of other people, if there is a real conflict of interest between the party who is suing and those whose rights the party claims to be attempting to defend?” Associate Justice Alito asked during oral arguments.

The hearing ended with no clear picture of how some justices were leaning. Justice Clarence Thomas and Justice Neil Gorsuch remained silent during arguments and asked no questions. Chief Justice John Roberts Jr., and Justice Brett Kavanaugh questioned whether all admitting privileges laws were unconstitutional or if a state-by-state analysis is required. Near the end of the hearing, Justice Stephen Breyer stressed that more research and fact-finding is necessary before the court can reach a decision.

“We’re not going to solve this at oral argument,” he said.

A decision by the Supreme Court is expected by August 2020.

agallegos@mdedge.com

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.

Treatment with the antifungal agent terbinafine during pregnancy does not appear to increase the risk of major malformations or spontaneous abortions, according to results from a large registry study in Denmark.

digitalskillet/Thinkstock

Physicians have been reluctant to prescribe the drug during pregnancy because of the limited safety data. The drug has not been associated with any signs of fetal toxicity in animal studies, but only one study – in 54 pregnancies – has examined the issue in humans and did not identify an increased fetal risk, according to Niklas Worm Andersson, MD, of the department of clinical pharmacology, Copenhagen University Hospital at Bispebjerg and Frederiksberg, and coauthors.

The retrospective, nationwide cohort study analyzed exposure to oral and tropical terbinafine in a large pregnancy registry and found no increase in the risk of major malformations or spontaneous abortions in exposed versus unexposed pregnancies. The study was published in JAMA Dermatology.

Still, these results fell short of certainty, the authors noted. “Although our results may provide reassurance for pregnancies exposed to oral terbinafine by reporting no overall increased risk of major malformations, we cannot exclude a potential increased risk of a specific malformation,” they wrote.

“To our knowledge, this is by far the largest, most statistically rigorous study in the literature regarding this topic,” Jenny E. Murase, MD, of the department of dermatology at the University of California, San Francisco, and Mary Kathryn Abel, a medical student at UCSF, wrote in an accompanying editorial. They described the study as “a substantial contribution to the nearly absent literature regarding the use of terbinafine during pregnancy. Among the antifungal medications, it is possible that terbinafine is the safest one currently available for use in pregnancy, particularly of the oral formulations.”

However, since asymptomatic onychomycosis “is typically a cosmetic, rather than medical, concern, waiting until after pregnancy to initiate therapy is reasonable. ... It is important to acknowledge the uncertainty in this field and question the appropriateness of treating non–life-threatening diseases during pregnancy and lactation,” they wrote.

The Danish researchers drew from a registry of 1,650,649 pregnancies between 1997 and 2016, which included 891 pregnancies exposed to oral terbinafine, and 3,174 exposed to topical terbinafine. Matched outcome analyses compared the exposed pregnancies with up to 40,650 controls unexposed during pregnancy.

Propensity-matched comparisons showed no increased risk of major malformations for oral terbinafine exposure versus no exposure (odds ratio, 1.01; 95% confidence interval, 0.63-1.62) or topical exposure versus no exposure (OR, 1.08; 95% CI, 0.81-1.44). There was also no difference in oral versus topical exposure (OR, 1.18; 95% CI, 0.61-2.29).

iStock

With respect to spontaneous abortions, there was no significant association with oral terbinafine (hazard ratio, 1.06; 95% CI, 0.86-1.32) or topical terbinafine (HR, 1.04; 95% CI, 0.88-1.21), compared with unexposed pregnancies, or oral over topical terbinafine-exposed pregnancies (HR, 1.19; 95% CI, 0.84-1.70).

The study is limited by the fact that it was conducted in a Danish population, and the data relied on filled prescriptions for determining exposure, which did not account for adherence. Residual confounding is possible because of the retrospective nature of the study, the authors pointed out.

No source of funding was disclosed. One of the authors has received grants and personal fees from Novartis. Dr. Murase has received fees from Sanofi Genzyme, Dermira, UCB, Regeneron, Ferndale, and UpToDate.
 

SOURCES: Andersson NW et al. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2020.0142; Murase JE, Abel MK. JAMA Dermatol. 2020 Mar 4. doi: 10.1001/jamadermatol.2019.5036.