Feature

This article is part of a series from Medscape on vaping.

Every day, Sonia Sharma, PA, meets people like Natalie H., who is trying to quit vaping.

Natalie, a member of the nicotine addiction support group at the University of California San Francisco’s Fontana Tobacco Treatment Center, switched from traditional cigarettes to vaping but found the electronic version just as addictive and eventually decided to quit using nicotine completely.

“I went from being an occasional cigarette smoker, a few a month, to a daily vaper,” said Natalie, who preferred not to give her last name to protect her privacy. “Vaping made my nicotine addiction worse, not better.”

“We have people tell us they vape before their feet hit the ground in the morning,” said Ms. Sharma, who coleads Natalie’s support group at UCSF. Ms. Sharma has met individuals who had smoked four to five cigarettes a day, switched to e-cigarettes to quit smoking, then vaped the equivalent of a pack a day. Others had switched to vapes to quit but ended up both vaping and smoking again. And others picked up vaping without ever smoking. They want to quit, she said, but are not sure how.

Researchers from the National Institutes of Health in 2020 reported that 5.6 million  adults in the United States vaped. A little over 57% of people said they started using e-cigarettes to quit smoking traditional cigarettes. Another study in 2021 based on survey data found that about 60% of e-cigarette users wanted to quit their vaping habit. 

Vaping has been marketed as a way to help people kick their smoking habit. Research is inconclusive on this claim. But unlike cessation tools like nicotine gums or lozenges, using vapes for cessation is uncharted territory. Vapers lack guidance for how to use the devices to quit, and they have even less direction on what to do if they develop an addiction to the vapes themselves.
 

A new addiction?

Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery in New Jersey, said she has witnessed a higher level of nicotine addiction in the vapers with whom she has worked.

“When someone takes a hit from a vaping device, it doesn’t generate the burn it would from traditional tobacco,” Ms. Hanna said. “This causes people to take a deeper pull, and when they take a deeper pull, they establish a higher level of nicotine dependence over time.” 

A 2019 study of nearly 900 people published in the New England Journal of Medicine found that smokers who used vapes for cessation were twice as likely to have quit smoking cigarettes as those who used other nicotine replacement therapy. However, 80% of people who switched to vaping were using e-cigarettes a year after they tried to quit smoking.

Given that potential for addiction, Nancy Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Center in Boston, said patients must use vapes “properly” for cessation. That means giving up smoking completely and quitting vapes as soon as patients are sure they will not go back to smoking tobacco.

“We are going to need to help these people to stop vaping,” said Dr. Rigotti, who is working with Achieve Life Sciences, a pharmaceutical company developing a prescription drug to treat nicotine addiction from vapes and cigarettes.

And many nicotine users who have tried vaping to quit smoking end up becoming dual users.

“It’s important to stress that health benefits [of switching to vaping] only occur if the switch to vapes is complete and permanent. So far, that appears difficult to do for most people who smoke, and in my anecdotal experience it has not worked,” said J. Taylor Hays, MD, the former medical director of Mayo Clinic’s Nicotine Dependence Center in Rochester, Minn.

Besides challenges in communicating the current evidence, no established method exists to help vapers quit, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society. 

“There are some experimental methods like using social interventions, counseling, and some educational campaigns,” Dr. Nargis said. “[Little] progress has been done in terms of clinical interventions.”

Unlike cessation products such as gum or a nicotine patch, which have clear recommendations for duration of use, similar guidelines don’t exist for vapes, in part because the U.S. Food and Drug Administration hasn’t yet granted approval of vapes as cessation products.

Alex Clark, the CEO of Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping, said people could vape for longer and still benefit from making the switch from traditional cigarettes.

“The most important thing is that people start replacing cigarettes with a smoke-free product and continue until they’ve completely switched,” said Mr. Clark, whose group accepts donations from the e-cigarette industry. “Following switching, people are encouraged to continue with the product for as long as they feel necessary.”

But 2013 guidelines from the FDA advised makers of nicotine-replacement therapies – including gums, patches, and lozenges – to include labeling that advises users to complete treatment. According to the agency, if a person feels like they “need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.”

Dr. Hays, who is now an emeritus professor at the Mayo Clinic, said he would not recommend patients try vaping as a cessation device given the availability of more proven techniques such as patches and gums. If a patient insists, vaping could be considered under the medical guidance of a cessation professional. He also advised people purchase products only from large tobacco companies that are likely to have “reasonable quality control.” Hundreds of vaping devices are on the market, and they are not all equivalent, he said.

But when an e-cigarette user wants to quit vaping, guidance might boil down to using traditional tobacco cessation methods like gums and lozenges because few tools exist to help people with a vaping-specific addiction.

The long-term health outcomes of vaping are also unclear, and decades will pass before scientists are able to make conclusions, according to Thomas Eissenberg, PhD, codirector of Virginia Commonwealth University’s Center for the Study of Tobacco Products in Richmond.

“I don’t think anyone knows what the long-term effects of heated propylene glycol and vegetable glycerin and flavors intended as food ingredients are, especially when these compounds are inhaled hundreds of times a day, week after week, year after year,” Dr. Eissenberg said.

Dr. Rigotti reported that she receives no funding from the tobacco or e-cigarette industry. She is working with Achieve Life Sciences to develop a tool for vaping cessation. Dr. Eissenberg, Ms. Hanna, Dr. Hays, Dr. Nargis, and Ms. Sharma reported no funding from the tobacco or e-cigarette industry.

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

This article is part of a series from Medscape on vaping.

Every day, Sonia Sharma, PA, meets people like Natalie H., who is trying to quit vaping.

Natalie, a member of the nicotine addiction support group at the University of California San Francisco’s Fontana Tobacco Treatment Center, switched from traditional cigarettes to vaping but found the electronic version just as addictive and eventually decided to quit using nicotine completely.

“I went from being an occasional cigarette smoker, a few a month, to a daily vaper,” said Natalie, who preferred not to give her last name to protect her privacy. “Vaping made my nicotine addiction worse, not better.”

“We have people tell us they vape before their feet hit the ground in the morning,” said Ms. Sharma, who coleads Natalie’s support group at UCSF. Ms. Sharma has met individuals who had smoked four to five cigarettes a day, switched to e-cigarettes to quit smoking, then vaped the equivalent of a pack a day. Others had switched to vapes to quit but ended up both vaping and smoking again. And others picked up vaping without ever smoking. They want to quit, she said, but are not sure how.

Researchers from the National Institutes of Health in 2020 reported that 5.6 million  adults in the United States vaped. A little over 57% of people said they started using e-cigarettes to quit smoking traditional cigarettes. Another study in 2021 based on survey data found that about 60% of e-cigarette users wanted to quit their vaping habit. 

Vaping has been marketed as a way to help people kick their smoking habit. Research is inconclusive on this claim. But unlike cessation tools like nicotine gums or lozenges, using vapes for cessation is uncharted territory. Vapers lack guidance for how to use the devices to quit, and they have even less direction on what to do if they develop an addiction to the vapes themselves.
 

A new addiction?

Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery in New Jersey, said she has witnessed a higher level of nicotine addiction in the vapers with whom she has worked.

“When someone takes a hit from a vaping device, it doesn’t generate the burn it would from traditional tobacco,” Ms. Hanna said. “This causes people to take a deeper pull, and when they take a deeper pull, they establish a higher level of nicotine dependence over time.” 

A 2019 study of nearly 900 people published in the New England Journal of Medicine found that smokers who used vapes for cessation were twice as likely to have quit smoking cigarettes as those who used other nicotine replacement therapy. However, 80% of people who switched to vaping were using e-cigarettes a year after they tried to quit smoking.

Given that potential for addiction, Nancy Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Center in Boston, said patients must use vapes “properly” for cessation. That means giving up smoking completely and quitting vapes as soon as patients are sure they will not go back to smoking tobacco.

“We are going to need to help these people to stop vaping,” said Dr. Rigotti, who is working with Achieve Life Sciences, a pharmaceutical company developing a prescription drug to treat nicotine addiction from vapes and cigarettes.

And many nicotine users who have tried vaping to quit smoking end up becoming dual users.

“It’s important to stress that health benefits [of switching to vaping] only occur if the switch to vapes is complete and permanent. So far, that appears difficult to do for most people who smoke, and in my anecdotal experience it has not worked,” said J. Taylor Hays, MD, the former medical director of Mayo Clinic’s Nicotine Dependence Center in Rochester, Minn.

Besides challenges in communicating the current evidence, no established method exists to help vapers quit, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society. 

“There are some experimental methods like using social interventions, counseling, and some educational campaigns,” Dr. Nargis said. “[Little] progress has been done in terms of clinical interventions.”

Unlike cessation products such as gum or a nicotine patch, which have clear recommendations for duration of use, similar guidelines don’t exist for vapes, in part because the U.S. Food and Drug Administration hasn’t yet granted approval of vapes as cessation products.

Alex Clark, the CEO of Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping, said people could vape for longer and still benefit from making the switch from traditional cigarettes.

“The most important thing is that people start replacing cigarettes with a smoke-free product and continue until they’ve completely switched,” said Mr. Clark, whose group accepts donations from the e-cigarette industry. “Following switching, people are encouraged to continue with the product for as long as they feel necessary.”

But 2013 guidelines from the FDA advised makers of nicotine-replacement therapies – including gums, patches, and lozenges – to include labeling that advises users to complete treatment. According to the agency, if a person feels like they “need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.”

Dr. Hays, who is now an emeritus professor at the Mayo Clinic, said he would not recommend patients try vaping as a cessation device given the availability of more proven techniques such as patches and gums. If a patient insists, vaping could be considered under the medical guidance of a cessation professional. He also advised people purchase products only from large tobacco companies that are likely to have “reasonable quality control.” Hundreds of vaping devices are on the market, and they are not all equivalent, he said.

But when an e-cigarette user wants to quit vaping, guidance might boil down to using traditional tobacco cessation methods like gums and lozenges because few tools exist to help people with a vaping-specific addiction.

The long-term health outcomes of vaping are also unclear, and decades will pass before scientists are able to make conclusions, according to Thomas Eissenberg, PhD, codirector of Virginia Commonwealth University’s Center for the Study of Tobacco Products in Richmond.

“I don’t think anyone knows what the long-term effects of heated propylene glycol and vegetable glycerin and flavors intended as food ingredients are, especially when these compounds are inhaled hundreds of times a day, week after week, year after year,” Dr. Eissenberg said.

Dr. Rigotti reported that she receives no funding from the tobacco or e-cigarette industry. She is working with Achieve Life Sciences to develop a tool for vaping cessation. Dr. Eissenberg, Ms. Hanna, Dr. Hays, Dr. Nargis, and Ms. Sharma reported no funding from the tobacco or e-cigarette industry.

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

This article is part of a series from Medscape on vaping.

Every day, Sonia Sharma, PA, meets people like Natalie H., who is trying to quit vaping.

Natalie, a member of the nicotine addiction support group at the University of California San Francisco’s Fontana Tobacco Treatment Center, switched from traditional cigarettes to vaping but found the electronic version just as addictive and eventually decided to quit using nicotine completely.

“I went from being an occasional cigarette smoker, a few a month, to a daily vaper,” said Natalie, who preferred not to give her last name to protect her privacy. “Vaping made my nicotine addiction worse, not better.”

“We have people tell us they vape before their feet hit the ground in the morning,” said Ms. Sharma, who coleads Natalie’s support group at UCSF. Ms. Sharma has met individuals who had smoked four to five cigarettes a day, switched to e-cigarettes to quit smoking, then vaped the equivalent of a pack a day. Others had switched to vapes to quit but ended up both vaping and smoking again. And others picked up vaping without ever smoking. They want to quit, she said, but are not sure how.

Researchers from the National Institutes of Health in 2020 reported that 5.6 million  adults in the United States vaped. A little over 57% of people said they started using e-cigarettes to quit smoking traditional cigarettes. Another study in 2021 based on survey data found that about 60% of e-cigarette users wanted to quit their vaping habit. 

Vaping has been marketed as a way to help people kick their smoking habit. Research is inconclusive on this claim. But unlike cessation tools like nicotine gums or lozenges, using vapes for cessation is uncharted territory. Vapers lack guidance for how to use the devices to quit, and they have even less direction on what to do if they develop an addiction to the vapes themselves.
 

A new addiction?

Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery in New Jersey, said she has witnessed a higher level of nicotine addiction in the vapers with whom she has worked.

“When someone takes a hit from a vaping device, it doesn’t generate the burn it would from traditional tobacco,” Ms. Hanna said. “This causes people to take a deeper pull, and when they take a deeper pull, they establish a higher level of nicotine dependence over time.” 

A 2019 study of nearly 900 people published in the New England Journal of Medicine found that smokers who used vapes for cessation were twice as likely to have quit smoking cigarettes as those who used other nicotine replacement therapy. However, 80% of people who switched to vaping were using e-cigarettes a year after they tried to quit smoking.

Given that potential for addiction, Nancy Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Center in Boston, said patients must use vapes “properly” for cessation. That means giving up smoking completely and quitting vapes as soon as patients are sure they will not go back to smoking tobacco.

“We are going to need to help these people to stop vaping,” said Dr. Rigotti, who is working with Achieve Life Sciences, a pharmaceutical company developing a prescription drug to treat nicotine addiction from vapes and cigarettes.

And many nicotine users who have tried vaping to quit smoking end up becoming dual users.

“It’s important to stress that health benefits [of switching to vaping] only occur if the switch to vapes is complete and permanent. So far, that appears difficult to do for most people who smoke, and in my anecdotal experience it has not worked,” said J. Taylor Hays, MD, the former medical director of Mayo Clinic’s Nicotine Dependence Center in Rochester, Minn.

Besides challenges in communicating the current evidence, no established method exists to help vapers quit, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society. 

“There are some experimental methods like using social interventions, counseling, and some educational campaigns,” Dr. Nargis said. “[Little] progress has been done in terms of clinical interventions.”

Unlike cessation products such as gum or a nicotine patch, which have clear recommendations for duration of use, similar guidelines don’t exist for vapes, in part because the U.S. Food and Drug Administration hasn’t yet granted approval of vapes as cessation products.

Alex Clark, the CEO of Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping, said people could vape for longer and still benefit from making the switch from traditional cigarettes.

“The most important thing is that people start replacing cigarettes with a smoke-free product and continue until they’ve completely switched,” said Mr. Clark, whose group accepts donations from the e-cigarette industry. “Following switching, people are encouraged to continue with the product for as long as they feel necessary.”

But 2013 guidelines from the FDA advised makers of nicotine-replacement therapies – including gums, patches, and lozenges – to include labeling that advises users to complete treatment. According to the agency, if a person feels like they “need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.”

Dr. Hays, who is now an emeritus professor at the Mayo Clinic, said he would not recommend patients try vaping as a cessation device given the availability of more proven techniques such as patches and gums. If a patient insists, vaping could be considered under the medical guidance of a cessation professional. He also advised people purchase products only from large tobacco companies that are likely to have “reasonable quality control.” Hundreds of vaping devices are on the market, and they are not all equivalent, he said.

But when an e-cigarette user wants to quit vaping, guidance might boil down to using traditional tobacco cessation methods like gums and lozenges because few tools exist to help people with a vaping-specific addiction.

The long-term health outcomes of vaping are also unclear, and decades will pass before scientists are able to make conclusions, according to Thomas Eissenberg, PhD, codirector of Virginia Commonwealth University’s Center for the Study of Tobacco Products in Richmond.

“I don’t think anyone knows what the long-term effects of heated propylene glycol and vegetable glycerin and flavors intended as food ingredients are, especially when these compounds are inhaled hundreds of times a day, week after week, year after year,” Dr. Eissenberg said.

Dr. Rigotti reported that she receives no funding from the tobacco or e-cigarette industry. She is working with Achieve Life Sciences to develop a tool for vaping cessation. Dr. Eissenberg, Ms. Hanna, Dr. Hays, Dr. Nargis, and Ms. Sharma reported no funding from the tobacco or e-cigarette industry.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

In 2014, after smoking cigarettes for 40 years, Kati Markowitz decided to switch to vaping. She had heard the newer electronic cigarettes might be less harmful. And, at the time, she said, she wasn’t aware of other options to try to quit smoking.

For 7 years, she vaped every day.

Then Ms. Markowitz received news she’d hoped never to hear: She had lung cancer. A nodule detected in a CT scan had grown. She was scheduled for treatment – the removal of an entire lobe from her right lung. But first, she said, her surgeon told her she had to quit vaping, which reduces the risk for post-operative complications and enables a healthy recovery.

Ms. Markowitz had thought switching to vaping would be less harmful than smoking cigarettes. Now, she no longer believes that’s true.

“Did I fool myself by hoping to get lucky and not have any bad repercussions? Yes, I did,” Ms. Markowitz said, adding that she wonders if vaping contributed to her lung cancer or if she’ll experience other negative health effects in the future.

Researchers are divided on if e-cigarettes are as effective in smoking cessation as other nicotine replacement therapies like gums and lozenges. They also say more research is needed on the long-term health impacts of vaping to ultimately determine if vapes are a safe replacement for cigarettes.

“There is scientific research to support vaping as a cessation tool, but we wouldn’t use it as a first line of defense because we still need longitudinal studies to understand the long-term risk of e-cigarettes,” said Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery, Eatontown, N.J. “We also need research to understand exactly how we could use e-cigarettes as a cessation device.”
 

Vaping to quit

The first prototypes of e-cigarettes were developed in the 1930s, although what are now known as vapes weren’t sold by manufacturers until the 2000s in the United States, following an invention by a former health official in China. The vape was touted by both researchers and manufacturers over the years of development as a way to quit smoking cigarettes.

The Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping and accepts donations from the e-cigarette industry, has compiled more than 13,000 testimonials from people who say vaping helped them give up smoking.

Studies show mixed results that using vapes can help traditional smokers quit.

A November 2022 Cochrane review showed a “high certainty of evidence that people are more likely to stop smoking traditional cigarettes for at least 6 months using e-cigarettes, or ‘vapes,’ than using nicotine replacement therapies, such as patches and gums.” The meta-analysis examined 78 studies with more than 22,000 participants. And a 2019 study with 886 participants, published in the New England Journal Medicine, found smokers who tried vaping to quit were twice as likely after a year to have stopped smoking cigarettes than those who used nicotine replacement therapy.

“In terms of the global research, it’s pretty clear that vaping can help smokers quit,” said Peter Shields, MD, a professor in the department of internal medicine at The Ohio State University College of Medicine, Columbus, who specializes in the treatment of lung cancer.

But a 2013 study published in the Lancet, and another from the Lancet in 2019, found only a modest improvement in cessation outcomes when participants used e-cigarettes paired with patches, compared with patches alone.

“For a disruptive technology that was supposed to end combustible tobacco use, there seems very little large-scale disruption,” said Thomas Eissenberg, PhD, co-director of Virginia Commonwealth University’s Center for the Study of Tobacco Products, Richmond.

Michael Joseph Blaha, MD, MPH, director of clinical research at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease, Baltimore, pointed to research that shows a portion of people who start vaping to quit smoking end up using both products – or become so-called “dual” users.

“I do think there is fairly high-quality evidence that vaping can lead to more cessation, but at the tradeoff of more long-term dual users and more overall nicotine addiction,” Dr. Blaha said. “Vaping remains a third-line clinical tool after nicotine replacement therapy and FDA-approved cessation medications.”

The U.S. Food and Drug Administration has not approved any e-cigarette or vaping device for smoking cessation, like it has for patches and gums, which means manufacturers cannot market their products as helping tobacco smokers quit.

“There is potential for vaping as a cessation device, but the evidence so far is too small to say for sure that vaping is a more effective tool than others for combustible tobacco cessation,” Ms. Hanna, from RWJBarnabas Health’s Institute for Prevention and Recovery, said.
 

Reducing harm and improving health?

Vapes have also been touted as a boon to individual and public health since cigarette smoking is the leading cause of preventable disease and disability in the United States, responsible for more than 480,000 deaths per year in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Quitting smoking lowers the risk of developing various cancers, heart disease, stroke, and other serious diseases. The aim of nicotine replacement therapy is to help smokers quit by gradually providing the body with smaller doses of nicotine over time, without exposing the body to toxic chemicals found in cigarettes.

“No one should say that e-cigarettes are safe, but compared to cigarettes, the data is consistent: They are not as harmful, and when a smoker switches, it’s better for them,” Dr. Shields said. “Like with other nicotine replacement therapies, if there is a risk that someone stops vaping and returns to smoking, I would rather have them as long-term vapers since it is generally considered to be less harmful than combustible tobacco.”

The FDA has allowed a handful of companies to market their electronic nicotine delivery systems as safer than traditional cigarettes by gaining approval through the Premarket Tobacco Product Applications process. In 2021, the agency announced its first PMTA authorization of an electronic cigarette to R.J. Reynolds for three of its tobacco-flavored vaping products. Regulators approved more products from three additional companies in 2022.

But the FDA has also denied others, including two products in 2023 from R.J. Reynolds, stating that, “the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.”

Questions remain among some researchers on the effects of vaping if used long term. Data on the health effects of vapes are just beginning to emerge and are mainly from studies of animals or cells. Measuring health effects among vape users will entail decades more of study, since Americans only gained access to the products in the 2000s.

Dr. Eissenberg said vaping likely does not cause the same diseases as cigarette smoking, but that does not mean they are not harmful. Ingredients found in e-cigarettes, such as heated propylene glycol, vegetable glycerin, and flavors, have only been used as food ingredients. The potential diseases caused by vapes are still unknown, because inhaling these heated ingredients is new. He also said he had “no issue” with an adult smoker vaping to help them quit smoking – as long they do so for a short period.

“I am very concerned that long-term use in adults could lead to considerable disease and death,” Dr. Eissenberg said. “Simply put, the human lung evolved for one purpose: gas exchange of oxygen in, carbon dioxide out. Anything else that enters the lung is a challenge to the organ.”

But Kenneth Warner, PhD, dean emeritus at the University of Michigan School of Public Health, Ann Arbor, said breaking the addiction to traditional cigarettes could reduce high rates of lung cancer in lower income communities where rates of smoking are comparatively high.

About three times as many Americans smoked (12.6%) than vaped (4.7%) in 2021, but those who live in households with lower incomes are more likely to smoke. According to the CDC, use of tobacco is higher among adults who were uninsured (27.3%) or who had Medicaid coverage (28.6%) than among those with private insurance (16.4%). People with annual family incomes of less than $12,500 also are more likely to be diagnosed with lung cancer than those with family incomes of $50,000 or more. Public health researchers have attributed those disparities in part to higher rates of smoking in lower-income households.

Dr. Warner said many lower-income and other Americans may never quit smoking cigarettes because they believe making the switch to e-cigarettes will not benefit their health. A 2022 study, published in the American Journal of Preventive Medicine, found that the percent of Americans who thought vaping was more harmful than smoking quadrupled between 2018 and 2020, from 6.8% to 28.3%. A third of respondents thought vaping was as harmful as smoking.

“We’ve convinced a large percentage of the American public that vaping is as harmful as smoking when it could be helping people quit smoking,” Dr. Warner said. “People are dying right now.”

Ms. Markowitz did quit smoking by taking up vaping. But now she questions if her lung cancer prognosis would have been delayed, or even avoided, if she’d tried a traditional method like a lozenge or gum instead. She vaped once an hour for most of her 7 years of using the devices.

“For people who are trying to stop smoking, I would recommend something like the patch instead,” Ms. Markowitz said.

The Consumer Advocates for Smoke-free Alternatives receives funding from the vaping industry. Dr. Blaha, Dr. Eissenberg, Ms. Hanna, Dr. Shields, and Dr. Warner reported no funding from the tobacco or e-cigarette industry. Dr. Blaha and Dr. Warner receive tobacco-related research funding from the FDA. Dr. Warner is a member of the FDA’s Tobacco Products Scientific Advisory Committee.

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

Filmmaker Gez Medinger and immunologist Danny Altmann have been dubbed by British media as “COVID’s odd couple,” and they don’t mind at all. Discussing their recent book, The Long COVID Handbook, the authors lean into their animated roles: Medinger is a passionate patient-researcher and “guinea pig” (his words) in search of his own healing, and Altmann is a no-nonsense, data-driven scientist and “Professor Boring” (as he puts it).

And the message they have about the impact of long COVID is stunning.

“The clinical burden [of long COVID] is somewhere on par with the whole of heart disease all over again, or the whole of oncology all over again, which are our biggest clinical bills concurrently,” Altmann said.

The pair met early in the pandemic, after Medinger became infected during the first wave and interviewed Altmann for his YouTube channel, which has more than 5 million views. 

“Danny was one of the first people from the medical establishment to sort of stand up on the parapet and wave a flag and say, ‘Hey, guys, there’s a problem here.’ And that was incredibly validating for 2 million people in the U.K. alone who were suffering with long COVID,” Medinger said. 

Their relationship works, not just for publishing one of the first definitive guides to long COVID, but also as a model for how patients with lived experiences can lead the way in medicine – from giving the condition its name to driving the medical establishment for recognition, clinical research, and therapeutic answers. 

With Altmann currently leading a major research project at Imperial College London on long COVID and Medinger’s social media platform and communication skills, they’re both advancing the world’s understanding of the disease in their own way.

“We’re now more than 3 years into this completely mysterious, uncharted disease process with a whole globe full of really desperate people,” said Altmann. “It’s a living, organic thing, and yet that also demands some kind of order and collation and pulling together into some kind of sense. So I was very pleased when Gez approached me to help him with the book.”

In it, they translate everything they’ve learned about the condition that’s “scattered in 100,000 places around the globe” into a digestible format. It tells two sides of the same story: the anecdotal experiences Medinger has undergone or observed in the long COVID community through more than a dozen of his own patient-led studies, as well the hard science and research that’s amassing in the medical world. 

In an interview, Medinger and Altmann discussed how their book can help both patients and clinicians, and the next steps needed to combat long COVID.
 

What are the book’s key takeaways for you?

Medinger: “I would say we put together an incredibly comprehensive couple of chapters on the hypotheses, big picture, what’s causing long COVID. And then the nitty-gritty research for everything that we’ve found out that is going on. ... And the other part of the book that I think is particularly important, beyond the tips for managing symptoms, is the content on mental health and the impact on your emotional state and your capacity and just how huge that is. ... That has been the most powerful thing for patients when they’ve read it. And they’ve said that they’ve just been crying all the way through those chapters because suddenly they feel heard and seen.”

Altmann: “Obviously, you’d expect me to say that the parts of the book that I love most are the kind of hard-nosed, medical, mechanistic bits. ... We’ve got 150 million-plus desperate people deciding or not deciding to go and see their general practitioner, getting a fair hearing or not getting a fair hearing. And the poor doctor has never learned this in medical school, has never read a textbook on it, and hasn’t a clue what’s coming through the door. 

How are they expected to know what to do? So I think the least we can do in some of those chapters is feed into their knowledge of general medicine and give them some clues. ... I think if we can explain to people what might be going on in them, and to their doctors, what on earth they might do about it, what kind of tests they might order, that helps a bit.”
 

How did you balance the more controversial parts of the book, including the chapter about so-called “treatments”? For instance, the book recounts Gez’s harrowing experience with ivermectin as a frightening warning. But Danny, you were nervous about even mentioning unproven and potentially dangerous treatments as things people have tried and have looked into. 

Medinger: “We had to try and work out how to handle the topic, how to handle those points of view, whilst at the same time still being informative. I think the book is stronger for that chapter, too. The other thing would certainly have been to just not address the subject, but it’s one of the things that people want to know the most about. And there’s also a lot of bad information floating around out there about certain treatments. Ivermectin, for example, and this is what happened to me when I tried it. ‘Don’t do it. It’s not recommended. Please don’t.’ 

I think it was also very important to include because that cautionary tale really applies to every single one of those treatments that people might be hearing about that hasn’t been backed up by efficacy and safety studies.”

Altmann: “I think Gez has been quite diplomatic. That chapter was, I think, a testament to the power of the book. And the biggest test of our marriage as ‘the odd couple.’ Because when I first read the first draft of what Gez had written, I said, ‘my name can’t even be on this book. Otherwise, I’ll be sacked.’ 

And we had to find marriage counseling after that, and a way back to write a version of that chapter that expressed both halves of those concerns in a way that did justice to those different viewpoints. And I think that makes it quite a strong chapter.”
 

What do you think are the most urgent next steps in the search for solving long COVID?

Medinger: “I would personally like to try and get some sort of answer on viral persistence. ... If there’s one thing that feels like it would be treatable in theory, and would make sense why we’re still getting all of these symptoms this whole time later, it’s that, so I would like to try and establish or eliminate viral persistence. So if you gave me Elon Musk’s wealth, that’s what I would throw a bunch of the money at, trying to either eliminate or establish that. 

And then, you know, the other important thing is a diagnostic test. Danny always talks about how important it is. Once you have that, it helps you suddenly open the doors to all these other things that you can do. And treatment trials. Let’s throw some meds at this so that we have an educated guess at what might work and put them into high-powered, randomized, controlled trials and see if anything comes out because from the patient perspective, I don’t think any of us wants to wait for 5 years for that stuff to start happening.”

Altmann: “I completely agree. If you go to a website, like clinicaltrials.gov, you’ll find an immense number of clinical trials on COVID. There isn’t really a shortage of them, some of them better-powered to get an answer than others.”

How do you think public policy needs to adapt for long COVID, including social safety nets such as workers’ compensation and disability benefits?

Medinger: “In terms of public policy, what I would like would be some public acknowledgment that it’s real from government sources. Just the acknowledgment that it’s real and it remains a risk even now.”

Altmann: “Nobody in politics asks my opinion. I think they’d hate to hear it. Because if I went to see them and said, well, actually, if you thought the COVID pandemic was bad, wait till you see what’s on the table now. We’ve created a disabled population in our country of 2 million, at least a portion if not more of people who are not fully contributory to the workforce anymore ... [with] legal wrangles about retirement and health insurance and pensions, and a human right to adequate health care. Which means, ideally, a purpose-built clinic where they can have their respiratory opinion and their rheumatology opinion and their endocrine opinion and their neurology opinion, all under one roof.”

You’ve both shown so much optimism. Why is that?

Altmann: “I’ve been an immunologist for a long time now, and written all my decades of grant applications, where as a community we made what, at the time, were kind of wild promises and wildly optimistic projections of how our knowledge of tumor immunity would revolutionize cancer care, and how knowledge of autoimmunity would revolutionize care of all the autoimmune diseases. 

And weirdly almost every word we wrote over those 25 or 30 years came true. Cancer immunotherapy was revolutionized, and biologics for diabetes, multiple sclerosis, and arthritis were revolutionized. So if I have faith that those things came true, I have complete faith in this as well.”

Medinger: “From the patient perspective, what I would say is that we are seeing people who’ve been ill for more than 2 years recover. People are suddenly turning the corner when they might not have expected to. 

And while we don’t quite know exactly why yet, and it’s not everyone, every single time I hear the story of someone saying, ‘I’m pretty much back to where I was, I feel like I’ve recovered,’ I feel great. Even if I haven’t. Because I know that every single time I hear someone say that, that just increases the probability that I will, too.”
 

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

Filmmaker Gez Medinger and immunologist Danny Altmann have been dubbed by British media as “COVID’s odd couple,” and they don’t mind at all. Discussing their recent book, The Long COVID Handbook, the authors lean into their animated roles: Medinger is a passionate patient-researcher and “guinea pig” (his words) in search of his own healing, and Altmann is a no-nonsense, data-driven scientist and “Professor Boring” (as he puts it).

And the message they have about the impact of long COVID is stunning.

“The clinical burden [of long COVID] is somewhere on par with the whole of heart disease all over again, or the whole of oncology all over again, which are our biggest clinical bills concurrently,” Altmann said.

The pair met early in the pandemic, after Medinger became infected during the first wave and interviewed Altmann for his YouTube channel, which has more than 5 million views. 

“Danny was one of the first people from the medical establishment to sort of stand up on the parapet and wave a flag and say, ‘Hey, guys, there’s a problem here.’ And that was incredibly validating for 2 million people in the U.K. alone who were suffering with long COVID,” Medinger said. 

Their relationship works, not just for publishing one of the first definitive guides to long COVID, but also as a model for how patients with lived experiences can lead the way in medicine – from giving the condition its name to driving the medical establishment for recognition, clinical research, and therapeutic answers. 

With Altmann currently leading a major research project at Imperial College London on long COVID and Medinger’s social media platform and communication skills, they’re both advancing the world’s understanding of the disease in their own way.

“We’re now more than 3 years into this completely mysterious, uncharted disease process with a whole globe full of really desperate people,” said Altmann. “It’s a living, organic thing, and yet that also demands some kind of order and collation and pulling together into some kind of sense. So I was very pleased when Gez approached me to help him with the book.”

In it, they translate everything they’ve learned about the condition that’s “scattered in 100,000 places around the globe” into a digestible format. It tells two sides of the same story: the anecdotal experiences Medinger has undergone or observed in the long COVID community through more than a dozen of his own patient-led studies, as well the hard science and research that’s amassing in the medical world. 

In an interview, Medinger and Altmann discussed how their book can help both patients and clinicians, and the next steps needed to combat long COVID.
 

What are the book’s key takeaways for you?

Medinger: “I would say we put together an incredibly comprehensive couple of chapters on the hypotheses, big picture, what’s causing long COVID. And then the nitty-gritty research for everything that we’ve found out that is going on. ... And the other part of the book that I think is particularly important, beyond the tips for managing symptoms, is the content on mental health and the impact on your emotional state and your capacity and just how huge that is. ... That has been the most powerful thing for patients when they’ve read it. And they’ve said that they’ve just been crying all the way through those chapters because suddenly they feel heard and seen.”

Altmann: “Obviously, you’d expect me to say that the parts of the book that I love most are the kind of hard-nosed, medical, mechanistic bits. ... We’ve got 150 million-plus desperate people deciding or not deciding to go and see their general practitioner, getting a fair hearing or not getting a fair hearing. And the poor doctor has never learned this in medical school, has never read a textbook on it, and hasn’t a clue what’s coming through the door. 

How are they expected to know what to do? So I think the least we can do in some of those chapters is feed into their knowledge of general medicine and give them some clues. ... I think if we can explain to people what might be going on in them, and to their doctors, what on earth they might do about it, what kind of tests they might order, that helps a bit.”
 

How did you balance the more controversial parts of the book, including the chapter about so-called “treatments”? For instance, the book recounts Gez’s harrowing experience with ivermectin as a frightening warning. But Danny, you were nervous about even mentioning unproven and potentially dangerous treatments as things people have tried and have looked into. 

Medinger: “We had to try and work out how to handle the topic, how to handle those points of view, whilst at the same time still being informative. I think the book is stronger for that chapter, too. The other thing would certainly have been to just not address the subject, but it’s one of the things that people want to know the most about. And there’s also a lot of bad information floating around out there about certain treatments. Ivermectin, for example, and this is what happened to me when I tried it. ‘Don’t do it. It’s not recommended. Please don’t.’ 

I think it was also very important to include because that cautionary tale really applies to every single one of those treatments that people might be hearing about that hasn’t been backed up by efficacy and safety studies.”

Altmann: “I think Gez has been quite diplomatic. That chapter was, I think, a testament to the power of the book. And the biggest test of our marriage as ‘the odd couple.’ Because when I first read the first draft of what Gez had written, I said, ‘my name can’t even be on this book. Otherwise, I’ll be sacked.’ 

And we had to find marriage counseling after that, and a way back to write a version of that chapter that expressed both halves of those concerns in a way that did justice to those different viewpoints. And I think that makes it quite a strong chapter.”
 

What do you think are the most urgent next steps in the search for solving long COVID?

Medinger: “I would personally like to try and get some sort of answer on viral persistence. ... If there’s one thing that feels like it would be treatable in theory, and would make sense why we’re still getting all of these symptoms this whole time later, it’s that, so I would like to try and establish or eliminate viral persistence. So if you gave me Elon Musk’s wealth, that’s what I would throw a bunch of the money at, trying to either eliminate or establish that. 

And then, you know, the other important thing is a diagnostic test. Danny always talks about how important it is. Once you have that, it helps you suddenly open the doors to all these other things that you can do. And treatment trials. Let’s throw some meds at this so that we have an educated guess at what might work and put them into high-powered, randomized, controlled trials and see if anything comes out because from the patient perspective, I don’t think any of us wants to wait for 5 years for that stuff to start happening.”

Altmann: “I completely agree. If you go to a website, like clinicaltrials.gov, you’ll find an immense number of clinical trials on COVID. There isn’t really a shortage of them, some of them better-powered to get an answer than others.”

How do you think public policy needs to adapt for long COVID, including social safety nets such as workers’ compensation and disability benefits?

Medinger: “In terms of public policy, what I would like would be some public acknowledgment that it’s real from government sources. Just the acknowledgment that it’s real and it remains a risk even now.”

Altmann: “Nobody in politics asks my opinion. I think they’d hate to hear it. Because if I went to see them and said, well, actually, if you thought the COVID pandemic was bad, wait till you see what’s on the table now. We’ve created a disabled population in our country of 2 million, at least a portion if not more of people who are not fully contributory to the workforce anymore ... [with] legal wrangles about retirement and health insurance and pensions, and a human right to adequate health care. Which means, ideally, a purpose-built clinic where they can have their respiratory opinion and their rheumatology opinion and their endocrine opinion and their neurology opinion, all under one roof.”

You’ve both shown so much optimism. Why is that?

Altmann: “I’ve been an immunologist for a long time now, and written all my decades of grant applications, where as a community we made what, at the time, were kind of wild promises and wildly optimistic projections of how our knowledge of tumor immunity would revolutionize cancer care, and how knowledge of autoimmunity would revolutionize care of all the autoimmune diseases. 

And weirdly almost every word we wrote over those 25 or 30 years came true. Cancer immunotherapy was revolutionized, and biologics for diabetes, multiple sclerosis, and arthritis were revolutionized. So if I have faith that those things came true, I have complete faith in this as well.”

Medinger: “From the patient perspective, what I would say is that we are seeing people who’ve been ill for more than 2 years recover. People are suddenly turning the corner when they might not have expected to. 

And while we don’t quite know exactly why yet, and it’s not everyone, every single time I hear the story of someone saying, ‘I’m pretty much back to where I was, I feel like I’ve recovered,’ I feel great. Even if I haven’t. Because I know that every single time I hear someone say that, that just increases the probability that I will, too.”
 

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

Filmmaker Gez Medinger and immunologist Danny Altmann have been dubbed by British media as “COVID’s odd couple,” and they don’t mind at all. Discussing their recent book, The Long COVID Handbook, the authors lean into their animated roles: Medinger is a passionate patient-researcher and “guinea pig” (his words) in search of his own healing, and Altmann is a no-nonsense, data-driven scientist and “Professor Boring” (as he puts it).

And the message they have about the impact of long COVID is stunning.

“The clinical burden [of long COVID] is somewhere on par with the whole of heart disease all over again, or the whole of oncology all over again, which are our biggest clinical bills concurrently,” Altmann said.

The pair met early in the pandemic, after Medinger became infected during the first wave and interviewed Altmann for his YouTube channel, which has more than 5 million views. 

“Danny was one of the first people from the medical establishment to sort of stand up on the parapet and wave a flag and say, ‘Hey, guys, there’s a problem here.’ And that was incredibly validating for 2 million people in the U.K. alone who were suffering with long COVID,” Medinger said. 

Their relationship works, not just for publishing one of the first definitive guides to long COVID, but also as a model for how patients with lived experiences can lead the way in medicine – from giving the condition its name to driving the medical establishment for recognition, clinical research, and therapeutic answers. 

With Altmann currently leading a major research project at Imperial College London on long COVID and Medinger’s social media platform and communication skills, they’re both advancing the world’s understanding of the disease in their own way.

“We’re now more than 3 years into this completely mysterious, uncharted disease process with a whole globe full of really desperate people,” said Altmann. “It’s a living, organic thing, and yet that also demands some kind of order and collation and pulling together into some kind of sense. So I was very pleased when Gez approached me to help him with the book.”

In it, they translate everything they’ve learned about the condition that’s “scattered in 100,000 places around the globe” into a digestible format. It tells two sides of the same story: the anecdotal experiences Medinger has undergone or observed in the long COVID community through more than a dozen of his own patient-led studies, as well the hard science and research that’s amassing in the medical world. 

In an interview, Medinger and Altmann discussed how their book can help both patients and clinicians, and the next steps needed to combat long COVID.
 

What are the book’s key takeaways for you?

Medinger: “I would say we put together an incredibly comprehensive couple of chapters on the hypotheses, big picture, what’s causing long COVID. And then the nitty-gritty research for everything that we’ve found out that is going on. ... And the other part of the book that I think is particularly important, beyond the tips for managing symptoms, is the content on mental health and the impact on your emotional state and your capacity and just how huge that is. ... That has been the most powerful thing for patients when they’ve read it. And they’ve said that they’ve just been crying all the way through those chapters because suddenly they feel heard and seen.”

Altmann: “Obviously, you’d expect me to say that the parts of the book that I love most are the kind of hard-nosed, medical, mechanistic bits. ... We’ve got 150 million-plus desperate people deciding or not deciding to go and see their general practitioner, getting a fair hearing or not getting a fair hearing. And the poor doctor has never learned this in medical school, has never read a textbook on it, and hasn’t a clue what’s coming through the door. 

How are they expected to know what to do? So I think the least we can do in some of those chapters is feed into their knowledge of general medicine and give them some clues. ... I think if we can explain to people what might be going on in them, and to their doctors, what on earth they might do about it, what kind of tests they might order, that helps a bit.”
 

How did you balance the more controversial parts of the book, including the chapter about so-called “treatments”? For instance, the book recounts Gez’s harrowing experience with ivermectin as a frightening warning. But Danny, you were nervous about even mentioning unproven and potentially dangerous treatments as things people have tried and have looked into. 

Medinger: “We had to try and work out how to handle the topic, how to handle those points of view, whilst at the same time still being informative. I think the book is stronger for that chapter, too. The other thing would certainly have been to just not address the subject, but it’s one of the things that people want to know the most about. And there’s also a lot of bad information floating around out there about certain treatments. Ivermectin, for example, and this is what happened to me when I tried it. ‘Don’t do it. It’s not recommended. Please don’t.’ 

I think it was also very important to include because that cautionary tale really applies to every single one of those treatments that people might be hearing about that hasn’t been backed up by efficacy and safety studies.”

Altmann: “I think Gez has been quite diplomatic. That chapter was, I think, a testament to the power of the book. And the biggest test of our marriage as ‘the odd couple.’ Because when I first read the first draft of what Gez had written, I said, ‘my name can’t even be on this book. Otherwise, I’ll be sacked.’ 

And we had to find marriage counseling after that, and a way back to write a version of that chapter that expressed both halves of those concerns in a way that did justice to those different viewpoints. And I think that makes it quite a strong chapter.”
 

What do you think are the most urgent next steps in the search for solving long COVID?

Medinger: “I would personally like to try and get some sort of answer on viral persistence. ... If there’s one thing that feels like it would be treatable in theory, and would make sense why we’re still getting all of these symptoms this whole time later, it’s that, so I would like to try and establish or eliminate viral persistence. So if you gave me Elon Musk’s wealth, that’s what I would throw a bunch of the money at, trying to either eliminate or establish that. 

And then, you know, the other important thing is a diagnostic test. Danny always talks about how important it is. Once you have that, it helps you suddenly open the doors to all these other things that you can do. And treatment trials. Let’s throw some meds at this so that we have an educated guess at what might work and put them into high-powered, randomized, controlled trials and see if anything comes out because from the patient perspective, I don’t think any of us wants to wait for 5 years for that stuff to start happening.”

Altmann: “I completely agree. If you go to a website, like clinicaltrials.gov, you’ll find an immense number of clinical trials on COVID. There isn’t really a shortage of them, some of them better-powered to get an answer than others.”

How do you think public policy needs to adapt for long COVID, including social safety nets such as workers’ compensation and disability benefits?

Medinger: “In terms of public policy, what I would like would be some public acknowledgment that it’s real from government sources. Just the acknowledgment that it’s real and it remains a risk even now.”

Altmann: “Nobody in politics asks my opinion. I think they’d hate to hear it. Because if I went to see them and said, well, actually, if you thought the COVID pandemic was bad, wait till you see what’s on the table now. We’ve created a disabled population in our country of 2 million, at least a portion if not more of people who are not fully contributory to the workforce anymore ... [with] legal wrangles about retirement and health insurance and pensions, and a human right to adequate health care. Which means, ideally, a purpose-built clinic where they can have their respiratory opinion and their rheumatology opinion and their endocrine opinion and their neurology opinion, all under one roof.”

You’ve both shown so much optimism. Why is that?

Altmann: “I’ve been an immunologist for a long time now, and written all my decades of grant applications, where as a community we made what, at the time, were kind of wild promises and wildly optimistic projections of how our knowledge of tumor immunity would revolutionize cancer care, and how knowledge of autoimmunity would revolutionize care of all the autoimmune diseases. 

And weirdly almost every word we wrote over those 25 or 30 years came true. Cancer immunotherapy was revolutionized, and biologics for diabetes, multiple sclerosis, and arthritis were revolutionized. So if I have faith that those things came true, I have complete faith in this as well.”

Medinger: “From the patient perspective, what I would say is that we are seeing people who’ve been ill for more than 2 years recover. People are suddenly turning the corner when they might not have expected to. 

And while we don’t quite know exactly why yet, and it’s not everyone, every single time I hear the story of someone saying, ‘I’m pretty much back to where I was, I feel like I’ve recovered,’ I feel great. Even if I haven’t. Because I know that every single time I hear someone say that, that just increases the probability that I will, too.”
 

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

You and me and baby makes 10,003

If you were a virus hunter, looking for your next big virus discovery, where would you go? The wholesale seafood market in Wuhan? A gathering of unmasked anti-vaxxers in the heartland of America? The frozen snot fields of northwest Siberia?

Comstock/Thinkstock

How about babies? Well, it’s too late now, because that’s what Dennis Sandris Nielsen, PhD, of the University of Copenhagen, and his associates did, and they hit the mother lode. Actually, it was more like the infant load, if we’re being honest here.

“We found an exceptional number of unknown viruses in the faeces of these babies,” Dr. Nielsen said in a written statement from the university. (The study was published in Nature Microbiology, so we get the English spelling of feces.)

The investigators mapped the gut “viromes” of 647 healthy Danish 1-year-old children over the course of 5 years and found 10,000 species of viruses distributed across 248 different viral families, of which only 16 were already known. Incredible stuff, but then things took a turn for the cute. “The researchers named the remaining 232 unknown viral families after the children whose diapers made the study possible. As a result, new viral families include names like Sylvesterviridae, Rigmorviridae and Tristanviridae,” the university said.

About 90% of the viruses found in the feces are bacterial viruses, aka bacteriophages, which have bacteria as their hosts and don’t attack the children’s cells, so they don’t cause disease. The other 10%, however, are eukaryotic: They use human cells as hosts, so they can be either friend or foe. “It is thought-provoking that all children run around with 10-20 of these virus types that infect human cells. So, there is a constant viral infection taking place, which apparently doesn’t make them sick,” Dr. Nielsen said.

Doesn’t make them sick? Riiiight. The thought that this gives rise to now? People love babies. Everyone wants to pick up the baby. Now we know why. Because the viruses want us to! Well, those cute little faces aren’t fooling us anymore. No more babies for us. Everyone should stay away from babies and their evil little eukaryotic viruses. STOP THE BABIES!

[Editor’s note: After a short timeout, we explained to the staff that the human species actually needs babies for its survival. They calmed down, picked up their crayons, and quietly went back to work.]

Fooled them. _{Stop the babies!}

At least someone out there appreciates hospital food

Life in Alaska is not for the meek. It’s dark half the year. Summer is 3 weeks in July. And somehow, there’s a moose in line ahead of you at the doctor’s office. To make matters worse, it’s arguing about insurance. “What do you mean, you’ve heard the Moo Cross Moo Shield joke before?”

Jean Beaufort/PublicDomainPictures.net

One might expect that Providence Alaska Health Park, located near downtown Anchorage, the largest city in Alaska by a massive margin, might be safe from ungulate invasion. Nope. In recent days, a young moose has taken to hanging around Providence campus, and it just could not find anything to eat. Remember, it may be early April, but this is Alaska. It’s still winter there. The ground’s still covered in snow.

Eventually, the gears in our young moose friend’s mind turned and it settled on a course of action: “Hey, those are some nice-looking plants behind that door over there. …” And that’s how Providence Alaska Health ended up with a moose munching on decorative potted plants in the hospital lobby.

Funnily enough, the moose didn’t even make a big scene. It just walked through the automatic doors and started chowing down. Security only found out because a tenant called them. Naturally though, once security made the announcement that a massive wild animal had been spotted in the building, the lobby was evacuated. … What do you mean, half the hospital came around to see it? Apparently, even though Alaskans have to fight moose herds on their daily commute, a lot of people wanted to see our moose friend do its thing.

“That’s crazy,” a woman in scrubs said in a video as she snapped a photo with her phone.

“This is the best. Like, what’s the code for this?” asked another bystander.

Despite security’s best efforts to shoo the moose out with barricades and offers of tasty branches, our furry friend left of its own volition, presumably irritated that his breakfast had become a spectator sport. But it didn’t go far. It hung around the front drive for a while, then went around the back of the building for a nap. What has four hooves and still doesn’t give a crap? Bob Moose-o! How you doing?
 

That click sounded stressed

How can people tell that you’re stressed? Maybe you get irritable and a little snappy. Some people have an inability to concentrate or focus. Eating that muffin when you weren’t really hungry could be a sign you’re not relaxed.

Georgijevic/E+/Getty Images

Did you know that your computer can be an indicator of your stress levels?

We tend to be working when we’re using computers, right? That can be a stressor in itself. Well, some researchers at ETH Zürich decided to have a look at the situation. Surprisingly, at least to us, one in three Swiss employees experience workplace stress, which makes us wonder what the percentage is in this country.

The Swiss researchers developed a model that tells how stressed someone is just by the way they use their computer mouse or type. The results of their study showed that those who were stressed clicked and tapped differently than participants who were more relaxed.

Stressed people click “more often and less precisely and cover longer distances on the screen,” while the relaxed take “shorter, more direct routes to reach their destination and take more time doing so,” study author Mara Nägelin explained in a written statement from ETH (Eidgenössische Technische Hochschule, or Swiss Federal Institute of Technology) Zürich.

Ever find when you’re frustrated and in a rush you end up making more mistakes? Same deal. Coauthor Jasmine Kerr noted that “increased levels of stress negatively impact our brain’s ability to process information.” Which totally is going to affect how we move.

Hopefully, these results can give insight to companies on how stressed their employees are and the effect it has on their work performance, eventually leading to, guess what, more research on how to alleviate workplace stress in general, which can benefit us all.

So if you find yourself in the office working on your computer like it’s a game of Perfection and time is running out, take a beat. Maybe try a stress-relieving breathing technique. Nonstressed people, according to the study, take fewer and longer pauses on their computers. Perfection on the job may mean relaxing first.

You and me and baby makes 10,003

If you were a virus hunter, looking for your next big virus discovery, where would you go? The wholesale seafood market in Wuhan? A gathering of unmasked anti-vaxxers in the heartland of America? The frozen snot fields of northwest Siberia?

Comstock/Thinkstock

How about babies? Well, it’s too late now, because that’s what Dennis Sandris Nielsen, PhD, of the University of Copenhagen, and his associates did, and they hit the mother lode. Actually, it was more like the infant load, if we’re being honest here.

“We found an exceptional number of unknown viruses in the faeces of these babies,” Dr. Nielsen said in a written statement from the university. (The study was published in Nature Microbiology, so we get the English spelling of feces.)

The investigators mapped the gut “viromes” of 647 healthy Danish 1-year-old children over the course of 5 years and found 10,000 species of viruses distributed across 248 different viral families, of which only 16 were already known. Incredible stuff, but then things took a turn for the cute. “The researchers named the remaining 232 unknown viral families after the children whose diapers made the study possible. As a result, new viral families include names like Sylvesterviridae, Rigmorviridae and Tristanviridae,” the university said.

About 90% of the viruses found in the feces are bacterial viruses, aka bacteriophages, which have bacteria as their hosts and don’t attack the children’s cells, so they don’t cause disease. The other 10%, however, are eukaryotic: They use human cells as hosts, so they can be either friend or foe. “It is thought-provoking that all children run around with 10-20 of these virus types that infect human cells. So, there is a constant viral infection taking place, which apparently doesn’t make them sick,” Dr. Nielsen said.

Doesn’t make them sick? Riiiight. The thought that this gives rise to now? People love babies. Everyone wants to pick up the baby. Now we know why. Because the viruses want us to! Well, those cute little faces aren’t fooling us anymore. No more babies for us. Everyone should stay away from babies and their evil little eukaryotic viruses. STOP THE BABIES!

[Editor’s note: After a short timeout, we explained to the staff that the human species actually needs babies for its survival. They calmed down, picked up their crayons, and quietly went back to work.]

Fooled them. _{Stop the babies!}

At least someone out there appreciates hospital food

Life in Alaska is not for the meek. It’s dark half the year. Summer is 3 weeks in July. And somehow, there’s a moose in line ahead of you at the doctor’s office. To make matters worse, it’s arguing about insurance. “What do you mean, you’ve heard the Moo Cross Moo Shield joke before?”

Jean Beaufort/PublicDomainPictures.net

One might expect that Providence Alaska Health Park, located near downtown Anchorage, the largest city in Alaska by a massive margin, might be safe from ungulate invasion. Nope. In recent days, a young moose has taken to hanging around Providence campus, and it just could not find anything to eat. Remember, it may be early April, but this is Alaska. It’s still winter there. The ground’s still covered in snow.

Eventually, the gears in our young moose friend’s mind turned and it settled on a course of action: “Hey, those are some nice-looking plants behind that door over there. …” And that’s how Providence Alaska Health ended up with a moose munching on decorative potted plants in the hospital lobby.

Funnily enough, the moose didn’t even make a big scene. It just walked through the automatic doors and started chowing down. Security only found out because a tenant called them. Naturally though, once security made the announcement that a massive wild animal had been spotted in the building, the lobby was evacuated. … What do you mean, half the hospital came around to see it? Apparently, even though Alaskans have to fight moose herds on their daily commute, a lot of people wanted to see our moose friend do its thing.

“That’s crazy,” a woman in scrubs said in a video as she snapped a photo with her phone.

“This is the best. Like, what’s the code for this?” asked another bystander.

Despite security’s best efforts to shoo the moose out with barricades and offers of tasty branches, our furry friend left of its own volition, presumably irritated that his breakfast had become a spectator sport. But it didn’t go far. It hung around the front drive for a while, then went around the back of the building for a nap. What has four hooves and still doesn’t give a crap? Bob Moose-o! How you doing?
 

That click sounded stressed

How can people tell that you’re stressed? Maybe you get irritable and a little snappy. Some people have an inability to concentrate or focus. Eating that muffin when you weren’t really hungry could be a sign you’re not relaxed.

Georgijevic/E+/Getty Images

Did you know that your computer can be an indicator of your stress levels?

We tend to be working when we’re using computers, right? That can be a stressor in itself. Well, some researchers at ETH Zürich decided to have a look at the situation. Surprisingly, at least to us, one in three Swiss employees experience workplace stress, which makes us wonder what the percentage is in this country.

The Swiss researchers developed a model that tells how stressed someone is just by the way they use their computer mouse or type. The results of their study showed that those who were stressed clicked and tapped differently than participants who were more relaxed.

Stressed people click “more often and less precisely and cover longer distances on the screen,” while the relaxed take “shorter, more direct routes to reach their destination and take more time doing so,” study author Mara Nägelin explained in a written statement from ETH (Eidgenössische Technische Hochschule, or Swiss Federal Institute of Technology) Zürich.

Ever find when you’re frustrated and in a rush you end up making more mistakes? Same deal. Coauthor Jasmine Kerr noted that “increased levels of stress negatively impact our brain’s ability to process information.” Which totally is going to affect how we move.

Hopefully, these results can give insight to companies on how stressed their employees are and the effect it has on their work performance, eventually leading to, guess what, more research on how to alleviate workplace stress in general, which can benefit us all.

So if you find yourself in the office working on your computer like it’s a game of Perfection and time is running out, take a beat. Maybe try a stress-relieving breathing technique. Nonstressed people, according to the study, take fewer and longer pauses on their computers. Perfection on the job may mean relaxing first.

You and me and baby makes 10,003

If you were a virus hunter, looking for your next big virus discovery, where would you go? The wholesale seafood market in Wuhan? A gathering of unmasked anti-vaxxers in the heartland of America? The frozen snot fields of northwest Siberia?

Comstock/Thinkstock

How about babies? Well, it’s too late now, because that’s what Dennis Sandris Nielsen, PhD, of the University of Copenhagen, and his associates did, and they hit the mother lode. Actually, it was more like the infant load, if we’re being honest here.

“We found an exceptional number of unknown viruses in the faeces of these babies,” Dr. Nielsen said in a written statement from the university. (The study was published in Nature Microbiology, so we get the English spelling of feces.)

The investigators mapped the gut “viromes” of 647 healthy Danish 1-year-old children over the course of 5 years and found 10,000 species of viruses distributed across 248 different viral families, of which only 16 were already known. Incredible stuff, but then things took a turn for the cute. “The researchers named the remaining 232 unknown viral families after the children whose diapers made the study possible. As a result, new viral families include names like Sylvesterviridae, Rigmorviridae and Tristanviridae,” the university said.

About 90% of the viruses found in the feces are bacterial viruses, aka bacteriophages, which have bacteria as their hosts and don’t attack the children’s cells, so they don’t cause disease. The other 10%, however, are eukaryotic: They use human cells as hosts, so they can be either friend or foe. “It is thought-provoking that all children run around with 10-20 of these virus types that infect human cells. So, there is a constant viral infection taking place, which apparently doesn’t make them sick,” Dr. Nielsen said.

Doesn’t make them sick? Riiiight. The thought that this gives rise to now? People love babies. Everyone wants to pick up the baby. Now we know why. Because the viruses want us to! Well, those cute little faces aren’t fooling us anymore. No more babies for us. Everyone should stay away from babies and their evil little eukaryotic viruses. STOP THE BABIES!

[Editor’s note: After a short timeout, we explained to the staff that the human species actually needs babies for its survival. They calmed down, picked up their crayons, and quietly went back to work.]

Fooled them. _{Stop the babies!}

At least someone out there appreciates hospital food

Life in Alaska is not for the meek. It’s dark half the year. Summer is 3 weeks in July. And somehow, there’s a moose in line ahead of you at the doctor’s office. To make matters worse, it’s arguing about insurance. “What do you mean, you’ve heard the Moo Cross Moo Shield joke before?”

Jean Beaufort/PublicDomainPictures.net

One might expect that Providence Alaska Health Park, located near downtown Anchorage, the largest city in Alaska by a massive margin, might be safe from ungulate invasion. Nope. In recent days, a young moose has taken to hanging around Providence campus, and it just could not find anything to eat. Remember, it may be early April, but this is Alaska. It’s still winter there. The ground’s still covered in snow.

Eventually, the gears in our young moose friend’s mind turned and it settled on a course of action: “Hey, those are some nice-looking plants behind that door over there. …” And that’s how Providence Alaska Health ended up with a moose munching on decorative potted plants in the hospital lobby.

Funnily enough, the moose didn’t even make a big scene. It just walked through the automatic doors and started chowing down. Security only found out because a tenant called them. Naturally though, once security made the announcement that a massive wild animal had been spotted in the building, the lobby was evacuated. … What do you mean, half the hospital came around to see it? Apparently, even though Alaskans have to fight moose herds on their daily commute, a lot of people wanted to see our moose friend do its thing.

“That’s crazy,” a woman in scrubs said in a video as she snapped a photo with her phone.

“This is the best. Like, what’s the code for this?” asked another bystander.

Despite security’s best efforts to shoo the moose out with barricades and offers of tasty branches, our furry friend left of its own volition, presumably irritated that his breakfast had become a spectator sport. But it didn’t go far. It hung around the front drive for a while, then went around the back of the building for a nap. What has four hooves and still doesn’t give a crap? Bob Moose-o! How you doing?
 

That click sounded stressed

How can people tell that you’re stressed? Maybe you get irritable and a little snappy. Some people have an inability to concentrate or focus. Eating that muffin when you weren’t really hungry could be a sign you’re not relaxed.

Georgijevic/E+/Getty Images

Did you know that your computer can be an indicator of your stress levels?

We tend to be working when we’re using computers, right? That can be a stressor in itself. Well, some researchers at ETH Zürich decided to have a look at the situation. Surprisingly, at least to us, one in three Swiss employees experience workplace stress, which makes us wonder what the percentage is in this country.

The Swiss researchers developed a model that tells how stressed someone is just by the way they use their computer mouse or type. The results of their study showed that those who were stressed clicked and tapped differently than participants who were more relaxed.

Stressed people click “more often and less precisely and cover longer distances on the screen,” while the relaxed take “shorter, more direct routes to reach their destination and take more time doing so,” study author Mara Nägelin explained in a written statement from ETH (Eidgenössische Technische Hochschule, or Swiss Federal Institute of Technology) Zürich.

Ever find when you’re frustrated and in a rush you end up making more mistakes? Same deal. Coauthor Jasmine Kerr noted that “increased levels of stress negatively impact our brain’s ability to process information.” Which totally is going to affect how we move.

Hopefully, these results can give insight to companies on how stressed their employees are and the effect it has on their work performance, eventually leading to, guess what, more research on how to alleviate workplace stress in general, which can benefit us all.

So if you find yourself in the office working on your computer like it’s a game of Perfection and time is running out, take a beat. Maybe try a stress-relieving breathing technique. Nonstressed people, according to the study, take fewer and longer pauses on their computers. Perfection on the job may mean relaxing first.

Court cases show that physicians continually underestimate their liability in supervising nurse practitioners (NPs) and physician assistants (PAs).

Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.

Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.

Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.

“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.

In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
 

Yet more states are removing supervision requirements

With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.

“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”

*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.

In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”

As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.

The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.

The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.

However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.

Court cases in which supervising physician was found liable

There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.

Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.

“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.

A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.

When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.

The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.

Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of  Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.

The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.

When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.

The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
 

Different standards for expert witnesses

In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.

These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.

Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
 

Supervision pointers from a physician

Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.

Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.

“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
 

Collaborating with autonomous NPs

Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.

At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”

The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
 

Conclusion

Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.

Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.

*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.

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

Court cases show that physicians continually underestimate their liability in supervising nurse practitioners (NPs) and physician assistants (PAs).

Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.

Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.

Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.

“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.

In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
 

Yet more states are removing supervision requirements

With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.

“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”

*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.

In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”

As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.

The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.

The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.

However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.

Court cases in which supervising physician was found liable

There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.

Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.

“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.

A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.

When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.

The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.

Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of  Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.

The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.

When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.

The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
 

Different standards for expert witnesses

In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.

These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.

Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
 

Supervision pointers from a physician

Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.

Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.

“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
 

Collaborating with autonomous NPs

Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.

At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”

The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
 

Conclusion

Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.

Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.

*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.

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

Court cases show that physicians continually underestimate their liability in supervising nurse practitioners (NPs) and physician assistants (PAs).

Even in states that have abolished requirements that NPs be physician-supervised, physicians may still be liable by virtue of employing the NP, according to William P. Sullivan, DO, an attorney and emergency physician in Frankfort, Ill.

Indeed, the vast majority of lawsuits against NPs and PAs name the supervising physician. According to a study of claims against NPs from 2011 to 2016, 82% of the cases also named the supervising physician.

Employed or contracted physicians assigned to supervise NPs or PAs are also affected, Dr. Sullivan said. “The employed physicians’ contract with a hospital or staffing company may require them to assist in the selection, supervision, and/or training of NPs or PAs,” he said. He added that supervisory duties may also be assigned through hospital bylaws.

“The physician is usually not paid anything extra for this work and may not be given extra time to perform it,” Dr. Sullivan said. But still, he said, that physician could be named in a lawsuit and wind up bearing some responsibility for an NP’s or PA’s mistake.

In addition to facing medical malpractice suits, Dr. Sullivan said, doctors are often sanctioned by state licensure boards for improperly supervising NPs and PAs. Licensure boards often require extensive protocols for supervision of NPs and PAs.
 

Yet more states are removing supervision requirements

With the addition of Kansas and New York in 2022 and California in 2023, 27 states no longer require supervision for all or most NPs. Sixteen of those states, including New York and California, have instituted progressive practice authority that requires temporary supervision of new NPs but then removes supervision after a period of 6 months to 4 years, depending on the state, for the rest of their career.

“When it comes to NP independence, the horse is already out of the barn,” Dr. Sullivan said. “It’s unlikely that states will repeal laws granting NPs independence, and in fact, more states are likely to pass them.”

*PAs, in contrast, are well behind NPs in achieving independence, but the American Academy of Physician Associates (AAPA) is calling to eliminate a mandated relationship with a specific physician. So far, Utah, North Dakota and Wyoming have ended physician supervision of PAs, while California and Hawaii have eliminated mandated chart review. Other states are considering eliminating physician supervision of PAs, according to the AAPA.

In states that have abolished oversight requirements for NPs, “liability can then shift to the NP when the NP is fully independent,” Cathy Klein, an advanced practice registered nurse who helped found the NP profession 50 years ago, told this news organization. “More NPs are starting their own practices, and in many cases, patients actually prefer to see an NP.”

As more NPs became more autonomous, the average payment that NPs incurred in professional liability lawsuits rose by 10.5% from 2017 to 2022, to $332,187, according to the Nurses Service Organization (NSO), a nursing malpractice insurer.

The number of malpractice judgments against autonomous NPs alone has also been rising. From 2012 to 2017, autonomous NPs’ share of all NP cases rose from 7% to 16.4%, the NSO reported.

The good news for physicians is that states’ removal of restrictions on NPs has reduced physicians’ liability to some extent. A 2017 study found that enacting less restrictive scope-of-practice laws for NPs decreased the number of payments made by physicians in NP cases by as much as 31%.

However, the top location for NP payouts remains the physician’s office, not the autonomous NP’s practice, according to the latter NSO report. Plaintiffs sue NPs’ and PAs’ supervising physicians on the basis of legal concepts, such as vicarious liability and respondeat superior. Even if the physician-employer never saw the patient, he or she can be held liable.

Court cases in which supervising physician was found liable

There are plenty of judgments against supervising or collaborating physicians when the NP or PA made the error. Typically, the doctor was faulted for paying little attention to the NP or PA he or she was supposed to supervise.

Dr. Sullivan points to a 2016 case in which a New York jury held a physician 40% liable for a $7 million judgment in a malpractice case involving a PA’s care of a patient in the emergency department. The case is Shajan v. South Nassau Community Hospital in New York.

“The patient presented with nontraumatic leg pain to his lower leg, was diagnosed by the PA with a muscle strain, and discharged without a physician evaluation,” Dr. Sullivan said. The next day, the patient visited an orthopedist who immediately diagnosed compartment syndrome, an emergent condition in which pressure builds up in an affected extremity, damaging the muscles and nerves. “The patient developed irreversible nerve damage and chronic regional pain syndrome,” he said.

A malpractice lawsuit named the PA and the emergency physician he was supposed to be reporting to. Even though the physician had never seen the patient, he had signed off on the PA’s note from a patient’s ED visit. “Testimony during the trial focused on hospital protocols that the supervising physician was supposed to take,” Dr. Sullivan said.

When doctors share fault, they frequently failed to follow the collaborative agreement with the NP or PA. In Collip v. Ratts, a 2015 Indiana case in which the patient died from a drug interaction, the doctor’s certified public accountant stated that the doctor was required to review at least 5% of the NP’s charts every week to evaluate her prescriptive practices.

The doctor admitted that he never reviewed the NP’s charts on a weekly basis. He did conduct some cursory reviews of some of the NP’s notes, and in them he noted concerns for her prescribing practices and suggested she attend a narcotics-prescribing seminar, but he did not follow up to make sure she had done this.

Sometimes the NP or PA who made the mistake may actually be dropped from the lawsuit, leaving the supervising physician fully liable. In these cases, courts reason that a fully engaged supervisor could have prevented the error. In the 2006 case of  Husak v. Siegal, the Florida Supreme Court dropped the NP from the case, ruling that the NP had provided the supervising doctor all the information he needed in order to tell her what to do for the patient.

The court noted the physician had failed to look at the chart, even though he was required to do so under his supervisory agreement with the NP. The doctor “could have made the correct diagnosis or referral had he been attentive,” the court said. Therefore, there was “no evidence of independent negligence” by the NP, even though she was the one who had made the incorrect diagnosis that harmed the patient.

When states require an autonomous NP to have a supervisory relationship with a doctor, the supervisor may be unavailable and may fail to designate a substitute. In Texas in January 2019, a 7-year-old girl died of pneumonia after being treated by an NP in an urgent care clinic. The NP had told the parents that the child could safely go home and only needed ibuprofen. The parents brought the girl back home, and she died 15 hours later. The Wattenbargers sued the NP, and the doctor’s supervision was a topic in the trial.

The supervising physician for the NP was out of the country at the time. He said that he had found a substitute, but the substitute doctor testified she had no idea she was designated to be the substitute, according to Niran Al-Agba, MD, a family physician in Silverdale, Wash., who has written on the Texas case. Dr. Al-Agba told this news organization the case appears to have been settled confidentially.
 

Different standards for expert witnesses

In many states, courts do not allow physicians to testify as expert witnesses in malpractice cases against NPs, arguing that nurses have a different set of standards than doctors have, Dr. Sullivan reported.

These states include Arkansas, Illinois, North Carolina, and New York, according to a report by SEAK Inc., an expert witness training program. The report said most other states allow physician experts in these cases, but they may still require that they have experience with the nursing standard of care.

Dr. Sullivan said some courts are whittling away at the ban on physician experts, and the ban may eventually disappear. He reported that in Oklahoma, which normally upholds the ban, a judge recently allowed a physician-expert to testify in a case involving the death of a 19-year-old woman, Alexus Ochoa, in an ED staffed by an NP. The judge reasoned that Ms. Ochoa’s parents assumed the ED was staffed by physicians and would adhere to medical standards.
 

Supervision pointers from a physician

Physicians who supervise NPs or PAs say it is important to keep track of their skills and help them sharpen their expertise. Their scope of practice and physicians’ supervisory responsibilities are included in the collaborative agreement.

Arthur Apolinario, MD, a family physician in Clinton, N.C., says his 10-physician practice, which employs six NPs and one PA, works under a collaborative agreement. “The agreement defines each person’s scope of practice. They can’t do certain procedures, such as surgery, and they need extra training before doing certain tasks alone, such as joint injection.

“You have to always figure that if there is a lawsuit against one of them, you as the supervising physician would be named,” said Dr. Apolinario, who is also president of the North Carolina Medical Society. “We try to avert mistakes by meeting regularly with our NPs and PAs and making sure they keep up to date.”
 

Collaborating with autonomous NPs

Even when NPs operate independently in states that have abolished supervision, physicians may still have some liability if they give NPs advice, Dr. Al-Agba said.

At her Washington state practice, Dr. Al-Agba shares an office with an autonomous NP. “We share overhead and a front desk, but we have separate patients,” Dr. Al-Agba said. “This arrangement works very well for both of us.”

The NP sometimes asks her for advice. When this occurs, Dr. Al-Agba said she always makes sure to see the patient first. “If you don’t actually see the patient, there could be a misunderstanding that could lead to an error,” she said.
 

Conclusion

Even though NPs now have autonomy in most states, supervising physicians may still be liable for NP malpractice by virtue of being their employers, and physicians in the remaining states are liable for NPs through state law and for PAs in virtually all the states. To determine the supervising physician’s fault, courts often study whether the physician has met the terms of the collaborative agreement.

Physicians can reduce collaborating NPs’ and PAs’ liability by properly training them, by verifying their scope of practice, by making themselves easily available for consultation, and by occasionally seeing their patients. If their NPs and PAs do commit malpractice, supervising physicians may be able to protect themselves from liability by adhering to all requirements of the collaborative agreement.

*Correction, 4/19/2023: An earlier version of this story misstated the name of the AAPA and the states that have ended physician supervision of PAs.

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

U.S. regulators may soon approve blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.

Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.

Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.

If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.

“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.

Blood tests for CRC have the potential to cause a shift in screening for colon cancer.

Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.

‘Holy grail?’

“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.

There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.

Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.

Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.

The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.

Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.

The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.

CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.

Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
 

A spotty track record

Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.

Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.

CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.

But CMS officials have acknowledged the strong interest in CRC blood tests.

In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:

• Receive FDA market authorization with an indication for CRC screening.
• Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.

In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.

Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.

While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.

Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.

“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
 

Hurdles to broad acceptance

For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.

This is the “big trifecta,” Dr. Baldo said.

In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.

The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).

The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.

If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.

Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.

“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
 

What the future may hold

Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.

In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.

Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.

And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.

“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.

Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.

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

U.S. regulators may soon approve blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.

Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.

Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.

If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.

“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.

Blood tests for CRC have the potential to cause a shift in screening for colon cancer.

Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.

‘Holy grail?’

“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.

There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.

Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.

Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.

The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.

Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.

The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.

CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.

Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
 

A spotty track record

Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.

Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.

CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.

But CMS officials have acknowledged the strong interest in CRC blood tests.

In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:

• Receive FDA market authorization with an indication for CRC screening.
• Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.

In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.

Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.

While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.

Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.

“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
 

Hurdles to broad acceptance

For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.

This is the “big trifecta,” Dr. Baldo said.

In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.

The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).

The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.

If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.

Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.

“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
 

What the future may hold

Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.

In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.

Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.

And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.

“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.

Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.

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

U.S. regulators may soon approve blood-based biomarker tests for colorectal cancer (CRC), expanding potential options for patients seeking more convenient forms of screening.

Most recently, Guardant Health announced the completion of its U.S. premarket approval application for its Shield blood test to screen for CRC. Approval by the Food and Drug Administration would position Guardant to later secure Medicare coverage for its test.

Rival companies, including CellMax Life, Freenome, and Exact Sciences, which already offers the stool-based Cologuard product, are pursuing similar paths in their development of blood tests for CRC.

If these companies succeed, clinicians and patients could have a choice of several FDA-approved tests in a few years.

“They’re coming, and they will be increasingly widely used,” said David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, Norfolk, who earlier in his career helped win broader insurance coverage of colonoscopy.

Blood tests for CRC have the potential to cause a shift in screening for colon cancer.

Screening colonoscopies ultimately could be largely phased out in the years ahead in favor of highly sensitive noninvasive tests, if the blood tests do as well as expected, said John M. Carethers, MD, AGAF, president of the American Gastroenterological Association.

‘Holy grail?’

“A blood test for cancer screening has been the ‘holy grail’ ever since the carcinoembryonic antigen blood test in the 1960s was claimed to have nearly 100% sensitivity and specificity – but turned out not to – for colorectal cancer,” wrote David F. Ransohoff, MD, a gastroenterologist at the University of North Carolina at Chapel Hill, in a 2021 article. Dr. Ransohoff has studied noninvasive CRC screening for decades.

There is a great allure in the idea of such multi-cancer detection (MCD) tests. “MCD technology offers the potential to detect asymptomatic cancer at several organ sites with a simple blood test, often called a liquid biopsy, ” according to a National Cancer Institute FY24 budget request report.

Several companies are selling MCD tests, some of which include CRC components. Among the best-known MCD tests now sold is Grail’s Galleri. At this time, however, the Galleri test, which tests for 50 types of cancer, should be used in addition to recommended colon cancer screening tests, such as colonoscopy, the company’s website says.

Guardant has also noted that its CRC-specific blood test should only complement screening tools, including colonoscopy, not replace them.

The prospect of phasing out more commonly used CRC screening – such as colonoscopy – may be appealing, but it would require a big shift for a field in which procedures have dominated. According to a report from the Centers for Disease Control and Prevention, in 2018, 67% of U.S. adults aged 50-75 years met the U.S. Preventive Services Task Force recommendations for CRC screening, and overall, 60.6% had a colonoscopy in the past 10 years.

Still, the NCI and the FDA have signaled the potential they see in MCD tests. The NCI highlighted its plans to aid MCD test development as part of its budget request for fiscal year 2024. The NCI is preparing to launch a 4-year pilot study for MCD tests to enroll 24,000 people aged 45-70 years. The study is intended as groundwork for a randomized controlled trial that will enroll 225,000 people.

The FDA has shown an interest in helping companies bring blood tests for cancer detection to market through its breakthrough device designation – a sign that the FDA places great priority on a product and seeks to streamline the application and review process.

CellMax Life appears to be the only CRC-specific screening blood test to have received a breakthrough device designation from the FDA, Atul Sharan, MS, MBA, cofounder and chief executive officer of CellMax Life, said in an email.

Lance Baldo, MD, Freenome’s chief medical officer, said in an interview that the FDA may be reviewing parts of their application in 2024, allowing for a potential 2025 launch of a blood test for asymptomatic people at average risk for CRC.
 

A spotty track record

Before anyone gets too excited about the prospect of phasing out screening colonoscopy, it’s important to remember that CRC blood tests have proven disappointing in the past.

Germany’s Epigenomics, for example, secured the first FDA approval for a CRC blood test, Epi ProColon, in 2016. But the company did not receive Medicare coverage for the test. In a 2021 memo explaining the decision, the Centers for Medicare & Medicaid Services noted that, given more reliable alternatives, including stool-based tests, the Epi ProColon would result in harm to some patients.

CMS also does not cover Grail’s blood test, which has a list price of $949, though the company has secured reimbursement arrangements with several self-insured employers and insurers, such as Point32Health.

But CMS officials have acknowledged the strong interest in CRC blood tests.

In that 2021 memo, the agency also outlined its requirements for Medicare coverage. CMS said it will cover blood-based screening tests for certain patients if these products meet the following standards:

• Receive FDA market authorization with an indication for CRC screening.
• Have proven test performance characteristics for a blood-based screening test with sensitivity of at least 74% and specificity of at least 90% in the detection of CRC, compared with the recognized standard (which at this time is colonoscopy) as minimal threshold levels, based on the pivotal studies included in the FDA labeling.

In February 2023, CellLife Max presented data at ASCO Gastrointestinal Cancers Symposium that its blood test had sensitivity of 92.1% for detection of CRC and 54.5% for detection of advanced adenomas, at 91% specificity.

Prior to that, in December 2022, Guardant issued a press release with study results that met the CMS standard. The test had sensitivity of 83% in detecting individuals with CRC. Specificity was 90%, the company said. That translates to a false positive rate of just 10%.

While such results look promising, Asad Umar, DVM, PhD, the chief of gastrointestinal and other cancers at NCI’s division of cancer prevention, said physicians should be cautious when giving advice or answering questions about MCD tests, given limited data from prospective studies about their effect on health outcomes.

Even among physicians already using some MCD tests to screen patients, there is a lot of concern about false-positive results that require diagnostic workup and false negative results that lead to a false sense of assurance, Dr. Umar said.

“Screening is a process and not just a test. The process involves follow-up testing for any positive test findings,” Dr. Umar said. “At this point, doctors should inform patients that there is not sufficient data to know how best to use these tests.”
 

Hurdles to broad acceptance

For companies seeking broad acceptance of a CRC blood test, two of the three major steps needed are securing FDA approval and Medicare coverage. The last step would be getting an A or B recommendation from the USPSTF, which would mandate coverage by health plans.

This is the “big trifecta,” Dr. Baldo said.

In the USPSTF’s current colon cancer screening recommendations, issued in 2021, it gave an A grade for CRC screening for adults aged 50-75 years and a B grade for those aged 45-49 years.

The USPSTF’s recommended forms of screening include colonoscopy, high-sensitivity guaiac fecal occult blood (gFOBT), fecal immunochemical test (FIT), flexible sigmoidoscopy (FS), stool DNA, and/or computed tomographic colonography (CTC).

The USPSTF says more research is needed to establish the accuracy and effectiveness of emerging screening technologies, such as blood or serum tests.

If CRC blood tests eventually win FDA approval, the USPSTF would likely provide guidance to clinicians on how patients can use them as a screening option.

Dr. Ransohoff noted that the mission of the USPSTF is different from that of the FDA and CMS. The FDA’s approach on medical tests is to consider overall safety and efficacy, as does CMS, but neither agency makes recommendations, nor does it perform its own rigorous quantitative assessment of benefit versus harm. The USPSTF, however, does its own detailed evidence-based reviews of the benefit versus harm of products, Dr. Ransohoff said.

“To me, the Task Force is the gold standard,” Dr. Ransohoff said. “You have to jump through the hoops with the FDA and CMS for making claims, to enable use, and to help get payment. But the Task Force looks at the choices and the consequences in a quantitative way and makes specific practice recommendations.”
 

What the future may hold

Dr. Carethers sees a future in which highly sensitive blood tests are able to largely replace screening colonoscopies. He said that colonoscopies would be used for people who are most in need of diagnosis and treatment. Dr. Carethers addressed these points during an AGA podcast released in January 2023.

In 20-25 years, colonoscopies may be only a therapeutic procedure, much like endoscopic retrograde cholangiopancreatography is now, Dr. Carethers added.

Even if CRC-specific blood tests prove to be effective screening tools, Dr. Ransohoff stressed that colonoscopy will survive. Many people will eventually need to undergo colonoscopy as a diagnostic procedure following a positive blood-based test result, and some may also opt for screening colonoscopies in lieu of frequent blood tests.

And, overall, physicians and patients will need to weigh the trade-offs of a noninvasive test that can only diagnose CRC versus a screening colonoscopy that offers preventative treatment as well.

“The best intent for screening is prevention of cancer, not detection of cancer,” said Dr. Johnson.

Dr. Carethers, Dr. Johnson, and Dr. Ransohoff reporting having no relevant financial conflicts of interest.

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

A whole new, tiny level of hangry

Ever been so hungry that everything just got on your nerves? Maybe you feel a little snappy right now? Like you’ll just lash out unless you get something to eat? Been there. And so have bacteria.

New research shows that some bacteria go into a full-on Hulk smash if they’re not getting the nutrients they need by releasing toxins into the body. Sounds like a bacterial temper tantrum.

Rosenthal et al.

Even though two cells may be genetically identical, they don’t always behave the same in a bacterial community. Some do their job and stay in line, but some evil twins rage out and make people sick by releasing toxins into the environment, Adam Rosenthal, PhD, of the University of North Carolina and his colleagues discovered.

To figure out why some cells were all business as usual while others were not, the investigators looked at Clostridium perfringens, a bacterium found in the intestines of humans and other vertebrates. When the C. perfringens cells were fed a little acetate to munch on, the hangry cells calmed down faster than a kid with a bag of fruit snacks, reducing toxin levels. Some cells even disappeared, falling in line with their model-citizen counterparts.

So what does this really mean? More research, duh. Now that we know nutrients play a role in toxicity, it may open the door to finding a way to fight against antibiotic resistance in humans and reduce antibiotic use in the food industry.

So think to yourself. Are you bothered for no reason? Getting a little testy with your friends and coworkers? Maybe you just haven’t eaten in a while. You’re literally not alone. Even a single-cell organism can behave based on its hunger levels.

Now go have a snack. Your bacteria are getting restless.
 

The very hangry iguana?

Imagine yourself on a warm, sunny tropical beach. You are enjoying a piece of cake as you take in the slow beat of the waves lapping against the shore. Life is as good as it could be.

Then you feel a presence nearby. Hostility. Hunger. A set of feral, covetous eyes in the nearby jungle. A reptilian beast stalks you, and its all-encompassing sweet tooth desires your cake.

Wait, hold on, what?

As an unfortunate 3-year-old on vacation in Costa Rica found out, there’s at least one iguana in the world out there with a taste for sugar (better than a taste for blood, we suppose).

Ulrike Mai/Pixabay

While out on the beach, the lizard darted out of nowhere, bit the girl on the back of the hand, and stole her cake. Still not the worst party guest ever. The child was taken to a local clinic, where the wound was cleaned and a 5-day antibiotic treatment (lizards carry salmonella) was provided. Things seemed fine, and the girl returned home without incident.

But of course, that’s not the end of the story. Five months later, the girl’s parents noticed a red bump at the wound site. Over the next 3 months, the surrounding skin grew red and painful. A trip to the hospital in California revealed that she had a ganglion cyst and a discharge of pus. Turns out our cake-obsessed lizard friend did give the little girl a gift: the first known human case of Mycobacterium marinum infection following an iguana bite on record.

M. marinum, which causes a disease similar to tuberculosis, typically infects fish but can infect humans if skin wounds are exposed to contaminated water. It’s also resistant to most antibiotics, which is why the first round didn’t clear up the infection. A second round of more-potent antibiotics seems to be working well.

So, to sum up, this poor child got bitten by a lizard, had her cake stolen, and contracted a rare illness in exchange. For a 3-year-old, that’s gotta be in the top-10 worst days ever. Unless, of course, we’re actually living in the Marvel universe (sorry, multiverse at this point). Then we’re totally going to see the emergence of the new superhero Iguana Girl in 15 years or so. Keep your eyes open.
 

No allergies? Let them give up cake

Allergy season is already here – starting earlier every year, it seems – and many people are not happy about it. So unhappy, actually, that there’s a list of things they would be willing to give up for a year to get rid of their of allergies, according to a survey conducted by OnePoll on behalf of Flonase.

nicoletaionescu/Getty Images

Nearly 40% of 2,000 respondents with allergies would go a year without eating cake or chocolate or playing video games in exchange for allergy-free status, the survey results show. Almost as many would forgo coffee (38%) or pizza (37%) for a year, while 36% would stay off social media and 31% would take a pay cut or give up their smartphones, the Independent reported.

More than half of the allergic Americans – 54%, to be exact – who were polled this past winter – Feb. 24 to March 1, to be exact – consider allergy symptoms to be the most frustrating part of the spring. Annoying things that were less frustrating to the group included mosquitoes (41%), filing tax returns (38%), and daylight savings time (37%).

The Trump arraignment circus, of course, occurred too late to make the list, as did the big “We’re going back to the office! No wait, we’re closing the office forever!” email extravaganza and emotional roller coaster. That second one, however, did not get nearly as much media coverage.

A whole new, tiny level of hangry

Ever been so hungry that everything just got on your nerves? Maybe you feel a little snappy right now? Like you’ll just lash out unless you get something to eat? Been there. And so have bacteria.

New research shows that some bacteria go into a full-on Hulk smash if they’re not getting the nutrients they need by releasing toxins into the body. Sounds like a bacterial temper tantrum.

Rosenthal et al.

Even though two cells may be genetically identical, they don’t always behave the same in a bacterial community. Some do their job and stay in line, but some evil twins rage out and make people sick by releasing toxins into the environment, Adam Rosenthal, PhD, of the University of North Carolina and his colleagues discovered.

To figure out why some cells were all business as usual while others were not, the investigators looked at Clostridium perfringens, a bacterium found in the intestines of humans and other vertebrates. When the C. perfringens cells were fed a little acetate to munch on, the hangry cells calmed down faster than a kid with a bag of fruit snacks, reducing toxin levels. Some cells even disappeared, falling in line with their model-citizen counterparts.

So what does this really mean? More research, duh. Now that we know nutrients play a role in toxicity, it may open the door to finding a way to fight against antibiotic resistance in humans and reduce antibiotic use in the food industry.

So think to yourself. Are you bothered for no reason? Getting a little testy with your friends and coworkers? Maybe you just haven’t eaten in a while. You’re literally not alone. Even a single-cell organism can behave based on its hunger levels.

Now go have a snack. Your bacteria are getting restless.
 

The very hangry iguana?

Imagine yourself on a warm, sunny tropical beach. You are enjoying a piece of cake as you take in the slow beat of the waves lapping against the shore. Life is as good as it could be.

Then you feel a presence nearby. Hostility. Hunger. A set of feral, covetous eyes in the nearby jungle. A reptilian beast stalks you, and its all-encompassing sweet tooth desires your cake.

Wait, hold on, what?

As an unfortunate 3-year-old on vacation in Costa Rica found out, there’s at least one iguana in the world out there with a taste for sugar (better than a taste for blood, we suppose).

Ulrike Mai/Pixabay

While out on the beach, the lizard darted out of nowhere, bit the girl on the back of the hand, and stole her cake. Still not the worst party guest ever. The child was taken to a local clinic, where the wound was cleaned and a 5-day antibiotic treatment (lizards carry salmonella) was provided. Things seemed fine, and the girl returned home without incident.

But of course, that’s not the end of the story. Five months later, the girl’s parents noticed a red bump at the wound site. Over the next 3 months, the surrounding skin grew red and painful. A trip to the hospital in California revealed that she had a ganglion cyst and a discharge of pus. Turns out our cake-obsessed lizard friend did give the little girl a gift: the first known human case of Mycobacterium marinum infection following an iguana bite on record.

M. marinum, which causes a disease similar to tuberculosis, typically infects fish but can infect humans if skin wounds are exposed to contaminated water. It’s also resistant to most antibiotics, which is why the first round didn’t clear up the infection. A second round of more-potent antibiotics seems to be working well.

So, to sum up, this poor child got bitten by a lizard, had her cake stolen, and contracted a rare illness in exchange. For a 3-year-old, that’s gotta be in the top-10 worst days ever. Unless, of course, we’re actually living in the Marvel universe (sorry, multiverse at this point). Then we’re totally going to see the emergence of the new superhero Iguana Girl in 15 years or so. Keep your eyes open.
 

No allergies? Let them give up cake

Allergy season is already here – starting earlier every year, it seems – and many people are not happy about it. So unhappy, actually, that there’s a list of things they would be willing to give up for a year to get rid of their of allergies, according to a survey conducted by OnePoll on behalf of Flonase.

nicoletaionescu/Getty Images

Nearly 40% of 2,000 respondents with allergies would go a year without eating cake or chocolate or playing video games in exchange for allergy-free status, the survey results show. Almost as many would forgo coffee (38%) or pizza (37%) for a year, while 36% would stay off social media and 31% would take a pay cut or give up their smartphones, the Independent reported.

More than half of the allergic Americans – 54%, to be exact – who were polled this past winter – Feb. 24 to March 1, to be exact – consider allergy symptoms to be the most frustrating part of the spring. Annoying things that were less frustrating to the group included mosquitoes (41%), filing tax returns (38%), and daylight savings time (37%).

The Trump arraignment circus, of course, occurred too late to make the list, as did the big “We’re going back to the office! No wait, we’re closing the office forever!” email extravaganza and emotional roller coaster. That second one, however, did not get nearly as much media coverage.

A whole new, tiny level of hangry

Ever been so hungry that everything just got on your nerves? Maybe you feel a little snappy right now? Like you’ll just lash out unless you get something to eat? Been there. And so have bacteria.

New research shows that some bacteria go into a full-on Hulk smash if they’re not getting the nutrients they need by releasing toxins into the body. Sounds like a bacterial temper tantrum.

Rosenthal et al.

Even though two cells may be genetically identical, they don’t always behave the same in a bacterial community. Some do their job and stay in line, but some evil twins rage out and make people sick by releasing toxins into the environment, Adam Rosenthal, PhD, of the University of North Carolina and his colleagues discovered.

To figure out why some cells were all business as usual while others were not, the investigators looked at Clostridium perfringens, a bacterium found in the intestines of humans and other vertebrates. When the C. perfringens cells were fed a little acetate to munch on, the hangry cells calmed down faster than a kid with a bag of fruit snacks, reducing toxin levels. Some cells even disappeared, falling in line with their model-citizen counterparts.

So what does this really mean? More research, duh. Now that we know nutrients play a role in toxicity, it may open the door to finding a way to fight against antibiotic resistance in humans and reduce antibiotic use in the food industry.

So think to yourself. Are you bothered for no reason? Getting a little testy with your friends and coworkers? Maybe you just haven’t eaten in a while. You’re literally not alone. Even a single-cell organism can behave based on its hunger levels.

Now go have a snack. Your bacteria are getting restless.
 

The very hangry iguana?

Imagine yourself on a warm, sunny tropical beach. You are enjoying a piece of cake as you take in the slow beat of the waves lapping against the shore. Life is as good as it could be.

Then you feel a presence nearby. Hostility. Hunger. A set of feral, covetous eyes in the nearby jungle. A reptilian beast stalks you, and its all-encompassing sweet tooth desires your cake.

Wait, hold on, what?

As an unfortunate 3-year-old on vacation in Costa Rica found out, there’s at least one iguana in the world out there with a taste for sugar (better than a taste for blood, we suppose).

Ulrike Mai/Pixabay

While out on the beach, the lizard darted out of nowhere, bit the girl on the back of the hand, and stole her cake. Still not the worst party guest ever. The child was taken to a local clinic, where the wound was cleaned and a 5-day antibiotic treatment (lizards carry salmonella) was provided. Things seemed fine, and the girl returned home without incident.

But of course, that’s not the end of the story. Five months later, the girl’s parents noticed a red bump at the wound site. Over the next 3 months, the surrounding skin grew red and painful. A trip to the hospital in California revealed that she had a ganglion cyst and a discharge of pus. Turns out our cake-obsessed lizard friend did give the little girl a gift: the first known human case of Mycobacterium marinum infection following an iguana bite on record.

M. marinum, which causes a disease similar to tuberculosis, typically infects fish but can infect humans if skin wounds are exposed to contaminated water. It’s also resistant to most antibiotics, which is why the first round didn’t clear up the infection. A second round of more-potent antibiotics seems to be working well.

So, to sum up, this poor child got bitten by a lizard, had her cake stolen, and contracted a rare illness in exchange. For a 3-year-old, that’s gotta be in the top-10 worst days ever. Unless, of course, we’re actually living in the Marvel universe (sorry, multiverse at this point). Then we’re totally going to see the emergence of the new superhero Iguana Girl in 15 years or so. Keep your eyes open.
 

No allergies? Let them give up cake

Allergy season is already here – starting earlier every year, it seems – and many people are not happy about it. So unhappy, actually, that there’s a list of things they would be willing to give up for a year to get rid of their of allergies, according to a survey conducted by OnePoll on behalf of Flonase.

nicoletaionescu/Getty Images

Nearly 40% of 2,000 respondents with allergies would go a year without eating cake or chocolate or playing video games in exchange for allergy-free status, the survey results show. Almost as many would forgo coffee (38%) or pizza (37%) for a year, while 36% would stay off social media and 31% would take a pay cut or give up their smartphones, the Independent reported.

More than half of the allergic Americans – 54%, to be exact – who were polled this past winter – Feb. 24 to March 1, to be exact – consider allergy symptoms to be the most frustrating part of the spring. Annoying things that were less frustrating to the group included mosquitoes (41%), filing tax returns (38%), and daylight savings time (37%).

The Trump arraignment circus, of course, occurred too late to make the list, as did the big “We’re going back to the office! No wait, we’re closing the office forever!” email extravaganza and emotional roller coaster. That second one, however, did not get nearly as much media coverage.

Lisa McCorkell had a mild bout of COVID-19 in March 2020. Young and healthy, she assumed that she would bounce back quickly. But when her fatigue, shortness of breath, and brain fog persisted, she realized that she most likely had long COVID. 

“Back then, we as patients basically coined the term,” she said. While her first primary care provider was sympathetic, they were unsure how to treat her. After her insurance changed, she ended up with a second primary care provider who didn’t take her symptoms seriously. “They dismissed my complaints and told me they were all in my head. I didn’t seek care for a while after that.”

Ms. McCorkell’s symptoms improved after her first COVID vaccine in the spring of 2021. She also finally found a new primary care doctor she could trust. But as one of the founders of the Patient-Led Research Collaborative, a group of researchers who study long COVID, she said many doctors still don’t know the hallmark symptoms of the condition or how to treat it. 

“There’s still a lack of education on what long COVID is, and the symptoms associated with it,” she said. “Many of the symptoms that occur in long COVID are symptoms of other chronic conditions, such as chronic fatigue syndrome, that are often dismissed. And even if providers believe patients and send them for a workup, many of the routine blood and imaging tests come back normal.”

The term “long COVID” emerged in May 2020. And though the condition was recognized within a few months of the start of the pandemic, doctors weren’t sure how to screen or treat it. 

While knowledge has developed since then, primary care doctors are still in a tough spot. They’re often the first providers that patients turn to when they have symptoms of long COVID. But with no standard diagnostic tests, treatment guidelines, standard care recommendations, and a large range of symptoms the condition can produce, doctors may not know what to look for, nor how to help patients.

“There’s no clear algorithm to pick up long COVID – there are no definite blood tests or biomarkers, or specific things to look for on a physical exam,” said Lawrence Purpura, MD, an infectious disease specialist and director of the long COVID clinic at Columbia University Medical Center, New York. “It’s a complicated disease that can impact every organ system of the body.”

Even so, emerging research has identified a checklist of sorts that doctors should consider when a patient seeks care for what appears to be long COVID. Among them: the key systems and organs impacted by the disease, the most common symptoms, useful therapeutic options for symptom management that have been found to help people with long COVID, and the best healthy lifestyle choices that doctors can recommend to help their patients 

Here’s a closer look at each of these aspects, based on research and interviews with experts, patients, and doctors. 
 

Key systems, organs impacted

About 10% of people who are infected with COVID-19 go on to have long COVID, according to a recent study that Ms. McCorkell helped coauthor. But more than 3 years into the pandemic, much about the condition is still a mystery.

COVID is a unique virus because it can spread far and wide in a patient’s body. A December 2022 study, published in Nature, autopsied 44 people who died of COVID and found that the virus could spread throughout the body and persist, in one case as long as 230 days after symptoms started. 

“We know that there are dozens of symptoms across multiple organ systems,” said Ms. McCorkell. “That makes it harder for a primary care physician to connect the dots and associate it with COVID.”

A paper published in Nature Medicine proposed one way to help guide diagnosis. It divided symptoms into four groups: 

• Cardiac and renal issues such as heart palpitations, chest pain, and kidney damage
• Sleep and anxiety problems like insomnia, waking up in the middle of the night, and anxiety
• In the musculoskeletal and nervous systems: musculoskeletal pain, osteoarthritis, and problems with mental skills
• In the digestive and respiratory systems: trouble breathing, asthma, stomach pain, nausea, and vomiting

There were also specific patterns in these groups. People in the first group were more likely to be older, male, have other conditions and to have been infected during the first wave of the COVID pandemic. People in the second group were over 60% female, and were more likely to have had previous allergies or asthma. The third group was also about 60% female, and many of them already had autoimmune conditions such as rheumatoid arthritis. Members of the fourth group – also 60% female – were the least likely of all the groups to have another condition.

This research is helpful, because it gives doctors a better sense of what conditions might make a patient more likely to get long COVID, as well as specific symptoms to look out for, said Steven Flanagan, MD, a physical medicine and rehabilitation specialist at New York University Langone Medical Center who also specializes in treating patients with long COVID. 

But the “challenge there, though, for health care providers is that not everyone will fall neatly into one of these categories,” he stressed.
 

Checklist of symptoms 

Although long COVID can be confusing, doctors say there are several symptoms that appear consistently that primary care providers should look out for, that could flag long COVID.

Postexertional malaise (PEM). This is different from simply feeling tired. “This term is often conflated with fatigue, but it’s very different,” said David Putrino, PhD, director of rehabilitation innovation at the Mount Sinai Health System in New York, who says that he sees it in about 90% of patients who come to his long COVID clinic. 

PEM is the worsening of symptoms after physical or mental exertion. This usually occurs a day or 2 after the activity, but it can last for days, and sometimes weeks. 

“It’s very different from fatigue, which is just a generalized tiredness, and exercise intolerance, where someone complains of not being able to do their usual workout on the treadmill,” he noted. “People with PEM are able to push through and do what they need to do, and then are hit with symptoms anywhere from 12 to 72 hours later.”

Dysautonomia. This is an umbrella term used to describe a dysfunction of the autonomic nervous system, which regulates bodily functions that you can’t control, like your blood pressure, heart rate, and breathing. This can cause symptoms such as heart palpitations, along with orthostatic intolerance, which means you can’t stand up for long without feeling faint or dizzy. 

“In my practice, about 80% of patients meet criteria for dysautonomia,” said Dr. Putrino. Other research has found that it’s present in about two-thirds of long COVID patients.

One relatively easy way primary care providers can diagnose dysautonomia is to do the tilt table test. This helps check for postural orthostatic tachycardia syndrome (POTS), one of the most common forms of dysautonomia. During this exam, the patient lies flat on a table. As the head of the table is raised to an almost upright position, their heart rate and blood pressure are measured. Signs of POTS include an abnormal heart rate when you’re upright, as well as a worsening of symptoms.

Exercise intolerance. A review published in the journal JAMA Network Open analyzed 38 studies on long COVID and exercise and found that patients with the condition had a much harder time doing physical activity. Exercise capacity was reduced to levels that would be expected about a decade later in life, according to study authors. 

“This is especially important because it can’t be explained just by deconditioning,” said Dr. Purpura. “Sometimes these patients are encouraged to ramp up exercise as a way to help with symptoms, but in these cases, encouraging them to push through can cause postexertional malaise, which sets patients back and delays recovery.”

While long COVID can cause dozens of symptoms, a paper Ms. McCorkell coauthored zeroed in on some of the most common ones: chest pain, heart palpitations, coughing, shortness of breath, belly pain, nausea, problems with mental skills, fatigue, disordered sleep, memory loss, ringing in the ears (tinnitus), erectile dysfunction, irregular menstruation, and worsened premenstrual syndrome.

While most primary care providers are familiar with some of these long COVID symptoms, they may not be aware of others. 

“COVID itself seems to cause hormonal changes that can lead to erection and menstrual cycle problems,” explained Dr. Putrino. “But these may not be picked up in a visit if the patient is complaining of other signs of long COVID.” 

It’s not just what symptoms are, but when they began to occur, he added. “Usually, these symptoms either start with the initial COVID infection, or begin sometime within 3 months after the acute COVID infection. That’s why it’s important for people with COVID to take notice of anything unusual that crops up within a month or 2 after getting sick.”
 

Can you prevent long COVID?

You can’t, but one of the best ways to reduce your risk is to get vaccinated. Getting at least one dose of a COVID vaccine before you test positive for COVID lowers your risk of long COVID by about 35% according to a study published in Antimicrobial Stewardship & Healthcare Epidemiology. Unvaccinated people who recovered from COVID, and then got a vaccine, lowered their own long COVID risk by 27%. 

In addition, a study published in JAMA Internal Medicine found that women who were infected with COVID were less likely to go on to get long COVID and/or have less debilitating symptoms if they had a healthy lifestyle, which included the following: a healthy weight (a body mass index between 18.5 and 24.7 kg/m²), never-smoker, moderate alcohol consumption, a high-quality diet, 7-9 hours of sleep a night, and at least 150 minutes per week of physical activity

But Ms. McCorkell noted that she herself had a healthy preinfection lifestyle but got long COVID anyway, suggesting these approaches don’t work for everyone.

“I think one reason my symptoms weren’t addressed by primary care physicians for so long is because they looked at me and saw that I was young and healthy, so they dismissed my reports as being all in my head,” she explained. “But we know now anyone can get long COVID, regardless of age, health status, or disease severity. That’s why it’s so important that primary care physicians be able to recognize symptoms.”

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

Lisa McCorkell had a mild bout of COVID-19 in March 2020. Young and healthy, she assumed that she would bounce back quickly. But when her fatigue, shortness of breath, and brain fog persisted, she realized that she most likely had long COVID. 

“Back then, we as patients basically coined the term,” she said. While her first primary care provider was sympathetic, they were unsure how to treat her. After her insurance changed, she ended up with a second primary care provider who didn’t take her symptoms seriously. “They dismissed my complaints and told me they were all in my head. I didn’t seek care for a while after that.”

Ms. McCorkell’s symptoms improved after her first COVID vaccine in the spring of 2021. She also finally found a new primary care doctor she could trust. But as one of the founders of the Patient-Led Research Collaborative, a group of researchers who study long COVID, she said many doctors still don’t know the hallmark symptoms of the condition or how to treat it. 

“There’s still a lack of education on what long COVID is, and the symptoms associated with it,” she said. “Many of the symptoms that occur in long COVID are symptoms of other chronic conditions, such as chronic fatigue syndrome, that are often dismissed. And even if providers believe patients and send them for a workup, many of the routine blood and imaging tests come back normal.”

The term “long COVID” emerged in May 2020. And though the condition was recognized within a few months of the start of the pandemic, doctors weren’t sure how to screen or treat it. 

While knowledge has developed since then, primary care doctors are still in a tough spot. They’re often the first providers that patients turn to when they have symptoms of long COVID. But with no standard diagnostic tests, treatment guidelines, standard care recommendations, and a large range of symptoms the condition can produce, doctors may not know what to look for, nor how to help patients.

“There’s no clear algorithm to pick up long COVID – there are no definite blood tests or biomarkers, or specific things to look for on a physical exam,” said Lawrence Purpura, MD, an infectious disease specialist and director of the long COVID clinic at Columbia University Medical Center, New York. “It’s a complicated disease that can impact every organ system of the body.”

Even so, emerging research has identified a checklist of sorts that doctors should consider when a patient seeks care for what appears to be long COVID. Among them: the key systems and organs impacted by the disease, the most common symptoms, useful therapeutic options for symptom management that have been found to help people with long COVID, and the best healthy lifestyle choices that doctors can recommend to help their patients 

Here’s a closer look at each of these aspects, based on research and interviews with experts, patients, and doctors. 
 

Key systems, organs impacted

About 10% of people who are infected with COVID-19 go on to have long COVID, according to a recent study that Ms. McCorkell helped coauthor. But more than 3 years into the pandemic, much about the condition is still a mystery.

COVID is a unique virus because it can spread far and wide in a patient’s body. A December 2022 study, published in Nature, autopsied 44 people who died of COVID and found that the virus could spread throughout the body and persist, in one case as long as 230 days after symptoms started. 

“We know that there are dozens of symptoms across multiple organ systems,” said Ms. McCorkell. “That makes it harder for a primary care physician to connect the dots and associate it with COVID.”

A paper published in Nature Medicine proposed one way to help guide diagnosis. It divided symptoms into four groups: 

• Cardiac and renal issues such as heart palpitations, chest pain, and kidney damage
• Sleep and anxiety problems like insomnia, waking up in the middle of the night, and anxiety
• In the musculoskeletal and nervous systems: musculoskeletal pain, osteoarthritis, and problems with mental skills
• In the digestive and respiratory systems: trouble breathing, asthma, stomach pain, nausea, and vomiting

There were also specific patterns in these groups. People in the first group were more likely to be older, male, have other conditions and to have been infected during the first wave of the COVID pandemic. People in the second group were over 60% female, and were more likely to have had previous allergies or asthma. The third group was also about 60% female, and many of them already had autoimmune conditions such as rheumatoid arthritis. Members of the fourth group – also 60% female – were the least likely of all the groups to have another condition.

This research is helpful, because it gives doctors a better sense of what conditions might make a patient more likely to get long COVID, as well as specific symptoms to look out for, said Steven Flanagan, MD, a physical medicine and rehabilitation specialist at New York University Langone Medical Center who also specializes in treating patients with long COVID. 

But the “challenge there, though, for health care providers is that not everyone will fall neatly into one of these categories,” he stressed.
 

Checklist of symptoms 

Although long COVID can be confusing, doctors say there are several symptoms that appear consistently that primary care providers should look out for, that could flag long COVID.

Postexertional malaise (PEM). This is different from simply feeling tired. “This term is often conflated with fatigue, but it’s very different,” said David Putrino, PhD, director of rehabilitation innovation at the Mount Sinai Health System in New York, who says that he sees it in about 90% of patients who come to his long COVID clinic. 

PEM is the worsening of symptoms after physical or mental exertion. This usually occurs a day or 2 after the activity, but it can last for days, and sometimes weeks. 

“It’s very different from fatigue, which is just a generalized tiredness, and exercise intolerance, where someone complains of not being able to do their usual workout on the treadmill,” he noted. “People with PEM are able to push through and do what they need to do, and then are hit with symptoms anywhere from 12 to 72 hours later.”

Dysautonomia. This is an umbrella term used to describe a dysfunction of the autonomic nervous system, which regulates bodily functions that you can’t control, like your blood pressure, heart rate, and breathing. This can cause symptoms such as heart palpitations, along with orthostatic intolerance, which means you can’t stand up for long without feeling faint or dizzy. 

“In my practice, about 80% of patients meet criteria for dysautonomia,” said Dr. Putrino. Other research has found that it’s present in about two-thirds of long COVID patients.

One relatively easy way primary care providers can diagnose dysautonomia is to do the tilt table test. This helps check for postural orthostatic tachycardia syndrome (POTS), one of the most common forms of dysautonomia. During this exam, the patient lies flat on a table. As the head of the table is raised to an almost upright position, their heart rate and blood pressure are measured. Signs of POTS include an abnormal heart rate when you’re upright, as well as a worsening of symptoms.

Exercise intolerance. A review published in the journal JAMA Network Open analyzed 38 studies on long COVID and exercise and found that patients with the condition had a much harder time doing physical activity. Exercise capacity was reduced to levels that would be expected about a decade later in life, according to study authors. 

“This is especially important because it can’t be explained just by deconditioning,” said Dr. Purpura. “Sometimes these patients are encouraged to ramp up exercise as a way to help with symptoms, but in these cases, encouraging them to push through can cause postexertional malaise, which sets patients back and delays recovery.”

While long COVID can cause dozens of symptoms, a paper Ms. McCorkell coauthored zeroed in on some of the most common ones: chest pain, heart palpitations, coughing, shortness of breath, belly pain, nausea, problems with mental skills, fatigue, disordered sleep, memory loss, ringing in the ears (tinnitus), erectile dysfunction, irregular menstruation, and worsened premenstrual syndrome.

While most primary care providers are familiar with some of these long COVID symptoms, they may not be aware of others. 

“COVID itself seems to cause hormonal changes that can lead to erection and menstrual cycle problems,” explained Dr. Putrino. “But these may not be picked up in a visit if the patient is complaining of other signs of long COVID.” 

It’s not just what symptoms are, but when they began to occur, he added. “Usually, these symptoms either start with the initial COVID infection, or begin sometime within 3 months after the acute COVID infection. That’s why it’s important for people with COVID to take notice of anything unusual that crops up within a month or 2 after getting sick.”
 

Can you prevent long COVID?

You can’t, but one of the best ways to reduce your risk is to get vaccinated. Getting at least one dose of a COVID vaccine before you test positive for COVID lowers your risk of long COVID by about 35% according to a study published in Antimicrobial Stewardship & Healthcare Epidemiology. Unvaccinated people who recovered from COVID, and then got a vaccine, lowered their own long COVID risk by 27%. 

In addition, a study published in JAMA Internal Medicine found that women who were infected with COVID were less likely to go on to get long COVID and/or have less debilitating symptoms if they had a healthy lifestyle, which included the following: a healthy weight (a body mass index between 18.5 and 24.7 kg/m²), never-smoker, moderate alcohol consumption, a high-quality diet, 7-9 hours of sleep a night, and at least 150 minutes per week of physical activity

But Ms. McCorkell noted that she herself had a healthy preinfection lifestyle but got long COVID anyway, suggesting these approaches don’t work for everyone.

“I think one reason my symptoms weren’t addressed by primary care physicians for so long is because they looked at me and saw that I was young and healthy, so they dismissed my reports as being all in my head,” she explained. “But we know now anyone can get long COVID, regardless of age, health status, or disease severity. That’s why it’s so important that primary care physicians be able to recognize symptoms.”

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

Lisa McCorkell had a mild bout of COVID-19 in March 2020. Young and healthy, she assumed that she would bounce back quickly. But when her fatigue, shortness of breath, and brain fog persisted, she realized that she most likely had long COVID. 

“Back then, we as patients basically coined the term,” she said. While her first primary care provider was sympathetic, they were unsure how to treat her. After her insurance changed, she ended up with a second primary care provider who didn’t take her symptoms seriously. “They dismissed my complaints and told me they were all in my head. I didn’t seek care for a while after that.”

Ms. McCorkell’s symptoms improved after her first COVID vaccine in the spring of 2021. She also finally found a new primary care doctor she could trust. But as one of the founders of the Patient-Led Research Collaborative, a group of researchers who study long COVID, she said many doctors still don’t know the hallmark symptoms of the condition or how to treat it. 

“There’s still a lack of education on what long COVID is, and the symptoms associated with it,” she said. “Many of the symptoms that occur in long COVID are symptoms of other chronic conditions, such as chronic fatigue syndrome, that are often dismissed. And even if providers believe patients and send them for a workup, many of the routine blood and imaging tests come back normal.”

The term “long COVID” emerged in May 2020. And though the condition was recognized within a few months of the start of the pandemic, doctors weren’t sure how to screen or treat it. 

While knowledge has developed since then, primary care doctors are still in a tough spot. They’re often the first providers that patients turn to when they have symptoms of long COVID. But with no standard diagnostic tests, treatment guidelines, standard care recommendations, and a large range of symptoms the condition can produce, doctors may not know what to look for, nor how to help patients.

“There’s no clear algorithm to pick up long COVID – there are no definite blood tests or biomarkers, or specific things to look for on a physical exam,” said Lawrence Purpura, MD, an infectious disease specialist and director of the long COVID clinic at Columbia University Medical Center, New York. “It’s a complicated disease that can impact every organ system of the body.”

Even so, emerging research has identified a checklist of sorts that doctors should consider when a patient seeks care for what appears to be long COVID. Among them: the key systems and organs impacted by the disease, the most common symptoms, useful therapeutic options for symptom management that have been found to help people with long COVID, and the best healthy lifestyle choices that doctors can recommend to help their patients 

Here’s a closer look at each of these aspects, based on research and interviews with experts, patients, and doctors. 
 

Key systems, organs impacted

About 10% of people who are infected with COVID-19 go on to have long COVID, according to a recent study that Ms. McCorkell helped coauthor. But more than 3 years into the pandemic, much about the condition is still a mystery.

COVID is a unique virus because it can spread far and wide in a patient’s body. A December 2022 study, published in Nature, autopsied 44 people who died of COVID and found that the virus could spread throughout the body and persist, in one case as long as 230 days after symptoms started. 

“We know that there are dozens of symptoms across multiple organ systems,” said Ms. McCorkell. “That makes it harder for a primary care physician to connect the dots and associate it with COVID.”

A paper published in Nature Medicine proposed one way to help guide diagnosis. It divided symptoms into four groups: 

• Cardiac and renal issues such as heart palpitations, chest pain, and kidney damage
• Sleep and anxiety problems like insomnia, waking up in the middle of the night, and anxiety
• In the musculoskeletal and nervous systems: musculoskeletal pain, osteoarthritis, and problems with mental skills
• In the digestive and respiratory systems: trouble breathing, asthma, stomach pain, nausea, and vomiting

There were also specific patterns in these groups. People in the first group were more likely to be older, male, have other conditions and to have been infected during the first wave of the COVID pandemic. People in the second group were over 60% female, and were more likely to have had previous allergies or asthma. The third group was also about 60% female, and many of them already had autoimmune conditions such as rheumatoid arthritis. Members of the fourth group – also 60% female – were the least likely of all the groups to have another condition.

This research is helpful, because it gives doctors a better sense of what conditions might make a patient more likely to get long COVID, as well as specific symptoms to look out for, said Steven Flanagan, MD, a physical medicine and rehabilitation specialist at New York University Langone Medical Center who also specializes in treating patients with long COVID. 

But the “challenge there, though, for health care providers is that not everyone will fall neatly into one of these categories,” he stressed.
 

Checklist of symptoms 

Although long COVID can be confusing, doctors say there are several symptoms that appear consistently that primary care providers should look out for, that could flag long COVID.

Postexertional malaise (PEM). This is different from simply feeling tired. “This term is often conflated with fatigue, but it’s very different,” said David Putrino, PhD, director of rehabilitation innovation at the Mount Sinai Health System in New York, who says that he sees it in about 90% of patients who come to his long COVID clinic. 

PEM is the worsening of symptoms after physical or mental exertion. This usually occurs a day or 2 after the activity, but it can last for days, and sometimes weeks. 

“It’s very different from fatigue, which is just a generalized tiredness, and exercise intolerance, where someone complains of not being able to do their usual workout on the treadmill,” he noted. “People with PEM are able to push through and do what they need to do, and then are hit with symptoms anywhere from 12 to 72 hours later.”

Dysautonomia. This is an umbrella term used to describe a dysfunction of the autonomic nervous system, which regulates bodily functions that you can’t control, like your blood pressure, heart rate, and breathing. This can cause symptoms such as heart palpitations, along with orthostatic intolerance, which means you can’t stand up for long without feeling faint or dizzy. 

“In my practice, about 80% of patients meet criteria for dysautonomia,” said Dr. Putrino. Other research has found that it’s present in about two-thirds of long COVID patients.

One relatively easy way primary care providers can diagnose dysautonomia is to do the tilt table test. This helps check for postural orthostatic tachycardia syndrome (POTS), one of the most common forms of dysautonomia. During this exam, the patient lies flat on a table. As the head of the table is raised to an almost upright position, their heart rate and blood pressure are measured. Signs of POTS include an abnormal heart rate when you’re upright, as well as a worsening of symptoms.

Exercise intolerance. A review published in the journal JAMA Network Open analyzed 38 studies on long COVID and exercise and found that patients with the condition had a much harder time doing physical activity. Exercise capacity was reduced to levels that would be expected about a decade later in life, according to study authors. 

“This is especially important because it can’t be explained just by deconditioning,” said Dr. Purpura. “Sometimes these patients are encouraged to ramp up exercise as a way to help with symptoms, but in these cases, encouraging them to push through can cause postexertional malaise, which sets patients back and delays recovery.”

While long COVID can cause dozens of symptoms, a paper Ms. McCorkell coauthored zeroed in on some of the most common ones: chest pain, heart palpitations, coughing, shortness of breath, belly pain, nausea, problems with mental skills, fatigue, disordered sleep, memory loss, ringing in the ears (tinnitus), erectile dysfunction, irregular menstruation, and worsened premenstrual syndrome.

While most primary care providers are familiar with some of these long COVID symptoms, they may not be aware of others. 

“COVID itself seems to cause hormonal changes that can lead to erection and menstrual cycle problems,” explained Dr. Putrino. “But these may not be picked up in a visit if the patient is complaining of other signs of long COVID.” 

It’s not just what symptoms are, but when they began to occur, he added. “Usually, these symptoms either start with the initial COVID infection, or begin sometime within 3 months after the acute COVID infection. That’s why it’s important for people with COVID to take notice of anything unusual that crops up within a month or 2 after getting sick.”
 

Can you prevent long COVID?

You can’t, but one of the best ways to reduce your risk is to get vaccinated. Getting at least one dose of a COVID vaccine before you test positive for COVID lowers your risk of long COVID by about 35% according to a study published in Antimicrobial Stewardship & Healthcare Epidemiology. Unvaccinated people who recovered from COVID, and then got a vaccine, lowered their own long COVID risk by 27%. 

In addition, a study published in JAMA Internal Medicine found that women who were infected with COVID were less likely to go on to get long COVID and/or have less debilitating symptoms if they had a healthy lifestyle, which included the following: a healthy weight (a body mass index between 18.5 and 24.7 kg/m²), never-smoker, moderate alcohol consumption, a high-quality diet, 7-9 hours of sleep a night, and at least 150 minutes per week of physical activity

But Ms. McCorkell noted that she herself had a healthy preinfection lifestyle but got long COVID anyway, suggesting these approaches don’t work for everyone.

“I think one reason my symptoms weren’t addressed by primary care physicians for so long is because they looked at me and saw that I was young and healthy, so they dismissed my reports as being all in my head,” she explained. “But we know now anyone can get long COVID, regardless of age, health status, or disease severity. That’s why it’s so important that primary care physicians be able to recognize symptoms.”

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

The youngest patient with cannabis-induced psychosis (CIP) whom Karen Randall, DO, has treated was a 7-year-old boy. She remembers the screaming, the yelling, the uncontrollable rage.

Dr. Randall is an emergency medicine physician at Southern Colorado Emergency Medicine Associates, a group practice in Pueblo, Colo. She treats youth for cannabis-related medical problems in the emergency department an average of two or three times per shift, she said.

Colorado legalized the recreational use of cannabis for adults older than 21 in 2012. Since then, Dr. Randall said, she has noticed an uptick in cannabis use among youth, as well as an increase in CIP, a syndrome that can be indistinguishable from other psychiatric disorders such as schizophrenia in the emergency department. But the two conditions require different approaches to care.

“You can’t differentiate unless you know the patient,” Dr. Randall said in an interview.

In 2019, 37% of high school students in the United States reported ever using marijuana, and 22% reported use in the past 30 days. Rates remained steady in 2020 following increases in 2018 and 2019, according to the Centers for Disease Control and Prevention.

The CDC also found that 8% of 8th graders, 19% of 10th graders, and 22% of 12th graders reported vaping marijuana in the past year.

Clinicians in states where recreational marijuana has been legalized say they have noticed an increase in young patients with psychiatric problems – especially after consumption of cannabis products in high doses. But CIP can be tricky to distinguish from psychoses of other causes, such as schizophrenia or bipolar disorder, which often begin to present in adolescence.
 

How to differentiate

CIP is characterized by delusions and hallucinations and sometimes anxiety, disorganized thoughts, paranoia, dissociation, and changes in mood and behavior. Symptoms typically last for a couple hours and do not require specific treatment, although they can persist, depending on a patient’s tolerance and the dose of tetrahydrocannabinol (THC) they have consumed. Research suggests that the higher the dose and concentration of the drug consumed, the more likely a person will develop symptoms of psychosis.

Diagnosis requires gathering information on previous bipolar disorder or schizophrenia diagnosis, prescriptions for mental illness indications, whether there is a family history of mental illness, and whether the patient recently started using marijuana. In some cases, marijuana use might exacerbate or unmask mental illness.

If symptoms of CIP resolve, and usually they do, clinicians can recommend that patients abstain from cannabis going forward, and psychosis would not need further treatment, according to Divya Singh, MD, a psychiatrist at Banner Behavioral Health Hospital in Scottsdale, Ariz., where recreational cannabis became legal in 2020.

“When I have limited information, especially in the first couple of days, I err on the side of safety,” Dr. Singh said.

Psychosis is the combination of symptoms, including delusions, hallucinations, and disorganized behavior, but it is not a disorder in itself. Rather, it is the primary symptom of schizophrenia and other chronic psychiatric illnesses.

Schizophrenia can be diagnosed only after a patient presents with signs of disturbance for at least 6 months, according to guidelines in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Dr. Singh said a diagnosis of schizophrenia cannot be made in a one-off interaction.

If the patient is younger than 24 years and has no family history of mental illness, a full recovery is likely if the patient abstains from marijuana, he said. But if the patient does have a family history, “the chances of them having a full-blown mental illness is very high,” Dr. Singh said.

If a patient reports that he or she has recently started using marijuana and was previously diagnosed with bipolar disorder or schizophrenia, Dr. Singh said he generally prescribes medications such as lithium or quetiapine and refers the patient to services such as cognitive-behavioral therapy. He also advises against continuing use of cannabis.

“Cannabis can result in people requiring a higher dose of medication than they took before,” Dr. Singh said. “If they were stable on 600 mg of lithium before, they might need more and may never be able to lower the dose in some cases, even after the acute episode.”
 

The science of cannabis

As of March 2023, 21 states and the District of Columbia permit the recreational use of marijuana, according to the Congressional Research Service. Thirty-seven states and the District of Columbia allow medicinal use of marijuana, and 10 states allow “limited access to medical cannabis,” defined as low-THC cannabis or cannabidiol (CBD) oil.

THC is the main psychoactive compound in cannabis. It creates a high feeling after binding with receptors in the brain that control pain and mood. CBD is another chemical found in cannabis, but it does not create a high.

Some research suggests cannabinoids may help reduce anxiety, reduce inflammation, relieve pain, control nausea, reduce cancer cells, slow the growth of tumor cells, relax tight muscles, and stimulate appetite.

The drug also carries risks, according to Mayo Clinic. Use of marijuana is linked to mental health problems in teens and adults, such as depression, social anxiety, and temporary psychosis, and long-lasting mental disorders, such as schizophrenia.

In the worst cases, CIP can persist for weeks or months – long after a negative drug test – and sometimes does not subside at all, according to Ken Finn, MD, president and founder of Springs Rehabilitation, PC, a pain medicine practice in Colorado Springs, Colo.

Dr. Finn, the co–vice president of the International Academy on the Science and Impact of Cannabis, which opposes making the drug more accessible, said educating health care providers is an urgent need.

Studies are mixed on whether the legalization of cannabis has led to more cases of CIP.

A 2021 study found that experiences of psychosis among users of cannabis jumped 2.5-fold between 2001 and 2013. But a study published earlier this year of more than 63 million medical claims from 2003 to 2017 found no statistically significant difference in rates of psychosis-related diagnoses or prescribed antipsychotics in states that have legalized medical or recreational cannabis compared with states where cannabis is still illegal. However, a secondary analysis did find that rates of psychosis-related diagnoses increased significantly among men, people aged 55-64 years, and Asian adults in states where recreational marijuana has been legalized.

Complicating matters, researchers say, is the question of causality. Cannabis may exacerbate or trigger psychosis, but people with an underlying psychological illness may also be more likely to use cannabis.

Dr. Finn said clinicians in Colorado and other states with legalization laws are seeing more patients with CIP. As more states consider legalizing recreational marijuana, he expects the data will reflect what doctors experience on the ground.

Cannabis-induced “psychosis is complicated and likely underdiagnosed,” Dr. Finn said.
 

Talking to teens

Clinicians outside the emergency department can play a role in aiding young people at risk for CIP. Primary care physicians, for instance, might explain to young patients that the brain only becomes fully developed at roughly age 26, after which the long-term health consequences of using cannabis become less likely. According to the CDC, using cannabis before age 18 can change how the brain builds connections and can impair attention, memory, and learning.

Dr. Singh takes a harm reduction approach when he engages with a patient who is forthcoming about substance use.

“If I see an 18-year-old, I tell them to abstain,” he said. “I tell them if they are ever going to use it, to use it after 26.”

Clinicians also should understand dosages to provide the optimal guidance to their patients who use cannabis.

“People often have no idea how much cannabis they are taking,” especially when using vape cartridges, Dr. Singh said. “If you don’t know, you can’t tell patients about the harms – and if you tell them the wrong information, they will write you off.”

Dr. Singh said he advises his patients to avoid using cannabis vapes or dabbing pens. Both can contain much higher levels of THC than dried flower or edible forms of the drug. He also says patients should stick with low concentrations and use products that contain CBD, which some studies have shown has a protective effect against CIP, although other studies have found that CBD can induce anxiety.

He also tells patients to buy from legal dispensaries and to avoid buying street products that may have methamphetamine or fentanyl mixed in.

Despite the risks, Dr. Singh said legalization can reduce the stigma associated with cannabis use and may prompt patients to be honest with their clinicians. Dr. Singh recalled a 28-year-old patient who was using cannabis to alleviate her arthritic pain. She also was taking a transplant medication, which carried potential side effects of delirium, generalized anxiety disorder, and hallucinosis. After doubling her THC dose, the patient experienced severe anxiety and paranoia.

Dr. Singh’s patient paid him a visit and asked for help. Dr. Singh told her to reduce the dose and to keep track of how she felt. If she continued to feel anxious and paranoid, he recommended that she switch to CBD instead.

“I think education and knowledge is liberating,” Dr. Singh said. “Legalization and frank conversations help people understand how to use a product – and right now, I think that’s lacking.”
 

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

The youngest patient with cannabis-induced psychosis (CIP) whom Karen Randall, DO, has treated was a 7-year-old boy. She remembers the screaming, the yelling, the uncontrollable rage.

Dr. Randall is an emergency medicine physician at Southern Colorado Emergency Medicine Associates, a group practice in Pueblo, Colo. She treats youth for cannabis-related medical problems in the emergency department an average of two or three times per shift, she said.

Colorado legalized the recreational use of cannabis for adults older than 21 in 2012. Since then, Dr. Randall said, she has noticed an uptick in cannabis use among youth, as well as an increase in CIP, a syndrome that can be indistinguishable from other psychiatric disorders such as schizophrenia in the emergency department. But the two conditions require different approaches to care.

“You can’t differentiate unless you know the patient,” Dr. Randall said in an interview.

In 2019, 37% of high school students in the United States reported ever using marijuana, and 22% reported use in the past 30 days. Rates remained steady in 2020 following increases in 2018 and 2019, according to the Centers for Disease Control and Prevention.

The CDC also found that 8% of 8th graders, 19% of 10th graders, and 22% of 12th graders reported vaping marijuana in the past year.

Clinicians in states where recreational marijuana has been legalized say they have noticed an increase in young patients with psychiatric problems – especially after consumption of cannabis products in high doses. But CIP can be tricky to distinguish from psychoses of other causes, such as schizophrenia or bipolar disorder, which often begin to present in adolescence.
 

How to differentiate

CIP is characterized by delusions and hallucinations and sometimes anxiety, disorganized thoughts, paranoia, dissociation, and changes in mood and behavior. Symptoms typically last for a couple hours and do not require specific treatment, although they can persist, depending on a patient’s tolerance and the dose of tetrahydrocannabinol (THC) they have consumed. Research suggests that the higher the dose and concentration of the drug consumed, the more likely a person will develop symptoms of psychosis.

Diagnosis requires gathering information on previous bipolar disorder or schizophrenia diagnosis, prescriptions for mental illness indications, whether there is a family history of mental illness, and whether the patient recently started using marijuana. In some cases, marijuana use might exacerbate or unmask mental illness.

If symptoms of CIP resolve, and usually they do, clinicians can recommend that patients abstain from cannabis going forward, and psychosis would not need further treatment, according to Divya Singh, MD, a psychiatrist at Banner Behavioral Health Hospital in Scottsdale, Ariz., where recreational cannabis became legal in 2020.

“When I have limited information, especially in the first couple of days, I err on the side of safety,” Dr. Singh said.

Psychosis is the combination of symptoms, including delusions, hallucinations, and disorganized behavior, but it is not a disorder in itself. Rather, it is the primary symptom of schizophrenia and other chronic psychiatric illnesses.

Schizophrenia can be diagnosed only after a patient presents with signs of disturbance for at least 6 months, according to guidelines in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Dr. Singh said a diagnosis of schizophrenia cannot be made in a one-off interaction.

If the patient is younger than 24 years and has no family history of mental illness, a full recovery is likely if the patient abstains from marijuana, he said. But if the patient does have a family history, “the chances of them having a full-blown mental illness is very high,” Dr. Singh said.

If a patient reports that he or she has recently started using marijuana and was previously diagnosed with bipolar disorder or schizophrenia, Dr. Singh said he generally prescribes medications such as lithium or quetiapine and refers the patient to services such as cognitive-behavioral therapy. He also advises against continuing use of cannabis.

“Cannabis can result in people requiring a higher dose of medication than they took before,” Dr. Singh said. “If they were stable on 600 mg of lithium before, they might need more and may never be able to lower the dose in some cases, even after the acute episode.”
 

The science of cannabis

As of March 2023, 21 states and the District of Columbia permit the recreational use of marijuana, according to the Congressional Research Service. Thirty-seven states and the District of Columbia allow medicinal use of marijuana, and 10 states allow “limited access to medical cannabis,” defined as low-THC cannabis or cannabidiol (CBD) oil.

THC is the main psychoactive compound in cannabis. It creates a high feeling after binding with receptors in the brain that control pain and mood. CBD is another chemical found in cannabis, but it does not create a high.

Some research suggests cannabinoids may help reduce anxiety, reduce inflammation, relieve pain, control nausea, reduce cancer cells, slow the growth of tumor cells, relax tight muscles, and stimulate appetite.

The drug also carries risks, according to Mayo Clinic. Use of marijuana is linked to mental health problems in teens and adults, such as depression, social anxiety, and temporary psychosis, and long-lasting mental disorders, such as schizophrenia.

In the worst cases, CIP can persist for weeks or months – long after a negative drug test – and sometimes does not subside at all, according to Ken Finn, MD, president and founder of Springs Rehabilitation, PC, a pain medicine practice in Colorado Springs, Colo.

Dr. Finn, the co–vice president of the International Academy on the Science and Impact of Cannabis, which opposes making the drug more accessible, said educating health care providers is an urgent need.

Studies are mixed on whether the legalization of cannabis has led to more cases of CIP.

A 2021 study found that experiences of psychosis among users of cannabis jumped 2.5-fold between 2001 and 2013. But a study published earlier this year of more than 63 million medical claims from 2003 to 2017 found no statistically significant difference in rates of psychosis-related diagnoses or prescribed antipsychotics in states that have legalized medical or recreational cannabis compared with states where cannabis is still illegal. However, a secondary analysis did find that rates of psychosis-related diagnoses increased significantly among men, people aged 55-64 years, and Asian adults in states where recreational marijuana has been legalized.

Complicating matters, researchers say, is the question of causality. Cannabis may exacerbate or trigger psychosis, but people with an underlying psychological illness may also be more likely to use cannabis.

Dr. Finn said clinicians in Colorado and other states with legalization laws are seeing more patients with CIP. As more states consider legalizing recreational marijuana, he expects the data will reflect what doctors experience on the ground.

Cannabis-induced “psychosis is complicated and likely underdiagnosed,” Dr. Finn said.
 

Talking to teens

Clinicians outside the emergency department can play a role in aiding young people at risk for CIP. Primary care physicians, for instance, might explain to young patients that the brain only becomes fully developed at roughly age 26, after which the long-term health consequences of using cannabis become less likely. According to the CDC, using cannabis before age 18 can change how the brain builds connections and can impair attention, memory, and learning.

Dr. Singh takes a harm reduction approach when he engages with a patient who is forthcoming about substance use.

“If I see an 18-year-old, I tell them to abstain,” he said. “I tell them if they are ever going to use it, to use it after 26.”

Clinicians also should understand dosages to provide the optimal guidance to their patients who use cannabis.

“People often have no idea how much cannabis they are taking,” especially when using vape cartridges, Dr. Singh said. “If you don’t know, you can’t tell patients about the harms – and if you tell them the wrong information, they will write you off.”

Dr. Singh said he advises his patients to avoid using cannabis vapes or dabbing pens. Both can contain much higher levels of THC than dried flower or edible forms of the drug. He also says patients should stick with low concentrations and use products that contain CBD, which some studies have shown has a protective effect against CIP, although other studies have found that CBD can induce anxiety.

He also tells patients to buy from legal dispensaries and to avoid buying street products that may have methamphetamine or fentanyl mixed in.

Despite the risks, Dr. Singh said legalization can reduce the stigma associated with cannabis use and may prompt patients to be honest with their clinicians. Dr. Singh recalled a 28-year-old patient who was using cannabis to alleviate her arthritic pain. She also was taking a transplant medication, which carried potential side effects of delirium, generalized anxiety disorder, and hallucinosis. After doubling her THC dose, the patient experienced severe anxiety and paranoia.

Dr. Singh’s patient paid him a visit and asked for help. Dr. Singh told her to reduce the dose and to keep track of how she felt. If she continued to feel anxious and paranoid, he recommended that she switch to CBD instead.

“I think education and knowledge is liberating,” Dr. Singh said. “Legalization and frank conversations help people understand how to use a product – and right now, I think that’s lacking.”
 

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

The youngest patient with cannabis-induced psychosis (CIP) whom Karen Randall, DO, has treated was a 7-year-old boy. She remembers the screaming, the yelling, the uncontrollable rage.

Dr. Randall is an emergency medicine physician at Southern Colorado Emergency Medicine Associates, a group practice in Pueblo, Colo. She treats youth for cannabis-related medical problems in the emergency department an average of two or three times per shift, she said.

Colorado legalized the recreational use of cannabis for adults older than 21 in 2012. Since then, Dr. Randall said, she has noticed an uptick in cannabis use among youth, as well as an increase in CIP, a syndrome that can be indistinguishable from other psychiatric disorders such as schizophrenia in the emergency department. But the two conditions require different approaches to care.

“You can’t differentiate unless you know the patient,” Dr. Randall said in an interview.

In 2019, 37% of high school students in the United States reported ever using marijuana, and 22% reported use in the past 30 days. Rates remained steady in 2020 following increases in 2018 and 2019, according to the Centers for Disease Control and Prevention.

The CDC also found that 8% of 8th graders, 19% of 10th graders, and 22% of 12th graders reported vaping marijuana in the past year.

Clinicians in states where recreational marijuana has been legalized say they have noticed an increase in young patients with psychiatric problems – especially after consumption of cannabis products in high doses. But CIP can be tricky to distinguish from psychoses of other causes, such as schizophrenia or bipolar disorder, which often begin to present in adolescence.
 

How to differentiate

CIP is characterized by delusions and hallucinations and sometimes anxiety, disorganized thoughts, paranoia, dissociation, and changes in mood and behavior. Symptoms typically last for a couple hours and do not require specific treatment, although they can persist, depending on a patient’s tolerance and the dose of tetrahydrocannabinol (THC) they have consumed. Research suggests that the higher the dose and concentration of the drug consumed, the more likely a person will develop symptoms of psychosis.

Diagnosis requires gathering information on previous bipolar disorder or schizophrenia diagnosis, prescriptions for mental illness indications, whether there is a family history of mental illness, and whether the patient recently started using marijuana. In some cases, marijuana use might exacerbate or unmask mental illness.

If symptoms of CIP resolve, and usually they do, clinicians can recommend that patients abstain from cannabis going forward, and psychosis would not need further treatment, according to Divya Singh, MD, a psychiatrist at Banner Behavioral Health Hospital in Scottsdale, Ariz., where recreational cannabis became legal in 2020.

“When I have limited information, especially in the first couple of days, I err on the side of safety,” Dr. Singh said.

Psychosis is the combination of symptoms, including delusions, hallucinations, and disorganized behavior, but it is not a disorder in itself. Rather, it is the primary symptom of schizophrenia and other chronic psychiatric illnesses.

Schizophrenia can be diagnosed only after a patient presents with signs of disturbance for at least 6 months, according to guidelines in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Dr. Singh said a diagnosis of schizophrenia cannot be made in a one-off interaction.

If the patient is younger than 24 years and has no family history of mental illness, a full recovery is likely if the patient abstains from marijuana, he said. But if the patient does have a family history, “the chances of them having a full-blown mental illness is very high,” Dr. Singh said.

If a patient reports that he or she has recently started using marijuana and was previously diagnosed with bipolar disorder or schizophrenia, Dr. Singh said he generally prescribes medications such as lithium or quetiapine and refers the patient to services such as cognitive-behavioral therapy. He also advises against continuing use of cannabis.

“Cannabis can result in people requiring a higher dose of medication than they took before,” Dr. Singh said. “If they were stable on 600 mg of lithium before, they might need more and may never be able to lower the dose in some cases, even after the acute episode.”
 

The science of cannabis

As of March 2023, 21 states and the District of Columbia permit the recreational use of marijuana, according to the Congressional Research Service. Thirty-seven states and the District of Columbia allow medicinal use of marijuana, and 10 states allow “limited access to medical cannabis,” defined as low-THC cannabis or cannabidiol (CBD) oil.

THC is the main psychoactive compound in cannabis. It creates a high feeling after binding with receptors in the brain that control pain and mood. CBD is another chemical found in cannabis, but it does not create a high.

Some research suggests cannabinoids may help reduce anxiety, reduce inflammation, relieve pain, control nausea, reduce cancer cells, slow the growth of tumor cells, relax tight muscles, and stimulate appetite.

The drug also carries risks, according to Mayo Clinic. Use of marijuana is linked to mental health problems in teens and adults, such as depression, social anxiety, and temporary psychosis, and long-lasting mental disorders, such as schizophrenia.

In the worst cases, CIP can persist for weeks or months – long after a negative drug test – and sometimes does not subside at all, according to Ken Finn, MD, president and founder of Springs Rehabilitation, PC, a pain medicine practice in Colorado Springs, Colo.

Dr. Finn, the co–vice president of the International Academy on the Science and Impact of Cannabis, which opposes making the drug more accessible, said educating health care providers is an urgent need.

Studies are mixed on whether the legalization of cannabis has led to more cases of CIP.

A 2021 study found that experiences of psychosis among users of cannabis jumped 2.5-fold between 2001 and 2013. But a study published earlier this year of more than 63 million medical claims from 2003 to 2017 found no statistically significant difference in rates of psychosis-related diagnoses or prescribed antipsychotics in states that have legalized medical or recreational cannabis compared with states where cannabis is still illegal. However, a secondary analysis did find that rates of psychosis-related diagnoses increased significantly among men, people aged 55-64 years, and Asian adults in states where recreational marijuana has been legalized.

Complicating matters, researchers say, is the question of causality. Cannabis may exacerbate or trigger psychosis, but people with an underlying psychological illness may also be more likely to use cannabis.

Dr. Finn said clinicians in Colorado and other states with legalization laws are seeing more patients with CIP. As more states consider legalizing recreational marijuana, he expects the data will reflect what doctors experience on the ground.

Cannabis-induced “psychosis is complicated and likely underdiagnosed,” Dr. Finn said.
 

Talking to teens

Clinicians outside the emergency department can play a role in aiding young people at risk for CIP. Primary care physicians, for instance, might explain to young patients that the brain only becomes fully developed at roughly age 26, after which the long-term health consequences of using cannabis become less likely. According to the CDC, using cannabis before age 18 can change how the brain builds connections and can impair attention, memory, and learning.

Dr. Singh takes a harm reduction approach when he engages with a patient who is forthcoming about substance use.

“If I see an 18-year-old, I tell them to abstain,” he said. “I tell them if they are ever going to use it, to use it after 26.”

Clinicians also should understand dosages to provide the optimal guidance to their patients who use cannabis.

“People often have no idea how much cannabis they are taking,” especially when using vape cartridges, Dr. Singh said. “If you don’t know, you can’t tell patients about the harms – and if you tell them the wrong information, they will write you off.”

Dr. Singh said he advises his patients to avoid using cannabis vapes or dabbing pens. Both can contain much higher levels of THC than dried flower or edible forms of the drug. He also says patients should stick with low concentrations and use products that contain CBD, which some studies have shown has a protective effect against CIP, although other studies have found that CBD can induce anxiety.

He also tells patients to buy from legal dispensaries and to avoid buying street products that may have methamphetamine or fentanyl mixed in.

Despite the risks, Dr. Singh said legalization can reduce the stigma associated with cannabis use and may prompt patients to be honest with their clinicians. Dr. Singh recalled a 28-year-old patient who was using cannabis to alleviate her arthritic pain. She also was taking a transplant medication, which carried potential side effects of delirium, generalized anxiety disorder, and hallucinosis. After doubling her THC dose, the patient experienced severe anxiety and paranoia.

Dr. Singh’s patient paid him a visit and asked for help. Dr. Singh told her to reduce the dose and to keep track of how she felt. If she continued to feel anxious and paranoid, he recommended that she switch to CBD instead.

“I think education and knowledge is liberating,” Dr. Singh said. “Legalization and frank conversations help people understand how to use a product – and right now, I think that’s lacking.”
 

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

“Did you love your wife?” asks a character in “Rose,” a book by Martin Cruz Smith.

“No, but she became a fact through perseverance,” the man replied.

Medicine also has such relationships, it seems – tentative ideas that turned into fact simply by existing long enough.

Age 65 as the cutoff for cervical screening may be one such example. It has existed for 27 years with limited science to back it up. That may soon change with the launch of a $3.3 million study that is being funded by the National Institutes of Health (NIH). The study is intended to provide a more solid foundation for the benefits and harms of cervical screening for women older than 65.

It’s an important issue: 20% of all cervical cancer cases are found in women who are older than 65. Most of these patients have late-stage disease, which can be fatal. In the United States, 35% of cervical cancer deaths occur after age 65. But women in this age group are usually no longer screened for cervical cancer.

Back in 1996, the U.S. Preventive Services Task Force recommended that for women at average risk with adequate prior screening, cervical screening should stop at the age of 65. This recommendation has been carried forward year after year and has been incorporated into several other guidelines.

For example, current guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the USPSTF recommend that cervical screening stop at aged 65 for patients with adequate prior screening.

“Adequate screening” is defined as three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative co-tests within the prior 10 years, with the most recent screening within 5 years and with no precancerous lesions in the past 25 years.

This all sounds reasonable; however, for most women, medical records aren’t up to the task of providing a clean bill of cervical health over many decades.

Explained Sarah Feldman, MD, an associate professor in obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston: “You know, when a patient says to me at 65, ‘Should I continue screening?’ I say, ‘Do you have all your results?’ And they’ll say, ‘Well, I remember I had a sort of abnormal pap 15 years ago,’ and I say, ‘All right; well, who knows what that was?’ So I’ll continue screening.”

According to George Sawaya, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, up to 60% of women do not meet the criteria to end screening at age 65. This means that each year in the United States, approximately 1.7 million women turn 65 and should, in theory, continue to undergo screening for cervical cancer.

Unfortunately, the evidence base for the harms and benefits of cervical screening after age 65 is almost nonexistent – at least by the current standards of evidence-based medicine.

“We need to be clear that we don’t really know the appropriateness of the screening after 65,” said Dr. Sawaya, “which is ironic, because cervical cancer screening is probably the most commonly implemented cancer screening test in the country because it starts so early and ends so late and it’s applied so frequently.”

Dr. Feldman agrees that the age 65 cutoff is “somewhat arbitrary.” She said, “Why don’t they want to consider it continuing past 65? I don’t really understand, I have to be honest with you.”

So what’s the scientific evidence backing up the 27-year-old recommendation?

In 2018, the USPSTF’s cervical-screening guidelines concluded “with moderate certainty that the benefits of screening in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer do not outweigh the potential harms.”

This recommendation was based on a new decision model commissioned by the USPSTF. The model was needed because, as noted by the guidelines’ authors, “None of the screening trials enrolled women older than 65 years, so direct evidence on when to stop screening is not available.”

In 2020, the ACS carried out a fresh literature review and published its own recommendations. The ACS concluded that “the evidence for the effectiveness of screening beyond age 65 is limited, based solely on observational and modeling studies.”

As a result, the ACS assigned a “qualified recommendation” to the age-65 moratorium (defined as “less certainty about the balance of benefits and harms or about patients’ values and preferences”).

Most recently, the 2021 Updated Cervical Cancer Screening Guidelines, published by the American College of Obstetricians and Gynecologists, endorsed the recommendations of the USPSTF.

Dr. Sawaya said, “The whole issue about screening over 65 is complicated from a lot of perspectives. We don’t know a lot about the safety. We don’t really know a lot about patients’ perceptions of it. But we do know that there has to be an upper age limit after which screening is just simply imprudent.”

Dr. Sawaya acknowledges that there exists a “heck-why-not” attitude toward cervical screening after 65 among some physicians, given that the tests are quick and cheap and could save a life, but he sounds a note of caution.

“It’s like when we used to use old cameras: the film was cheap, but the developing was really expensive,” Dr. Sawaya said. “So it’s not necessarily about the tests being cheap, it’s about the cascade of events [that follow].”

Follow-up for cervical cancer can be more hazardous for a postmenopausal patient than for a younger woman, explained Dr. Sawaya, because the transformation zone of the cervix may be difficult to see on colposcopy. Instead of a straightforward 5-minute procedure in the doctor’s office, the older patient may need the operating room simply to provide the first biopsy.

In addition, treatments such as cone biopsy, loop excision, or ablation are also more worrying for older women, said Dr. Sawaya, “So you start thinking about the risks of anesthesia, you start thinking about the risks of bleeding and infection, etc. And these have not been well described in older people.”

To add to the uncertainty about the merits and risks of hunting out cervical cancer in older women, a lot has changed in women’s health since 1996.

Explained Dr. Sawaya, “This stake was put in the ground in 1996, ... but since that time, life expectancy has gained 5 years. So a logical person would say, ‘Oh, well, let’s just say it should be 70 now, right?’ [But] can we even use old studies to inform the current cohort of women who are entering this 65-year-and-older age group?”

To answer all these questions, a 5-year, $3.3 million study funded by the NIH through the National Cancer Institute is now underway.

The project, named Comparative Effectiveness Research to Validate and Improve Cervical Cancer Screening (CERVICCS 2), will be led by Dr. Sawaya and Michael Silverberg, PhD, associate director of the Behavioral Health, Aging and Infectious Diseases Section of Kaiser Permanente Northern California’s Division of Research.

Dr. Sawaya concluded: “There’s very few things that are packaged away and thought to be just the truth. And this is why we always have to be vigilant. ... And that’s what keeps science so interesting and exciting.”

Dr. Sawaya has disclosed no relevant financial relationships. Dr. Feldman writes for UpToDate and receives several NIH grants.

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

“Did you love your wife?” asks a character in “Rose,” a book by Martin Cruz Smith.

“No, but she became a fact through perseverance,” the man replied.

Medicine also has such relationships, it seems – tentative ideas that turned into fact simply by existing long enough.

Age 65 as the cutoff for cervical screening may be one such example. It has existed for 27 years with limited science to back it up. That may soon change with the launch of a $3.3 million study that is being funded by the National Institutes of Health (NIH). The study is intended to provide a more solid foundation for the benefits and harms of cervical screening for women older than 65.

It’s an important issue: 20% of all cervical cancer cases are found in women who are older than 65. Most of these patients have late-stage disease, which can be fatal. In the United States, 35% of cervical cancer deaths occur after age 65. But women in this age group are usually no longer screened for cervical cancer.

Back in 1996, the U.S. Preventive Services Task Force recommended that for women at average risk with adequate prior screening, cervical screening should stop at the age of 65. This recommendation has been carried forward year after year and has been incorporated into several other guidelines.

For example, current guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the USPSTF recommend that cervical screening stop at aged 65 for patients with adequate prior screening.

“Adequate screening” is defined as three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative co-tests within the prior 10 years, with the most recent screening within 5 years and with no precancerous lesions in the past 25 years.

This all sounds reasonable; however, for most women, medical records aren’t up to the task of providing a clean bill of cervical health over many decades.

Explained Sarah Feldman, MD, an associate professor in obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston: “You know, when a patient says to me at 65, ‘Should I continue screening?’ I say, ‘Do you have all your results?’ And they’ll say, ‘Well, I remember I had a sort of abnormal pap 15 years ago,’ and I say, ‘All right; well, who knows what that was?’ So I’ll continue screening.”

According to George Sawaya, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, up to 60% of women do not meet the criteria to end screening at age 65. This means that each year in the United States, approximately 1.7 million women turn 65 and should, in theory, continue to undergo screening for cervical cancer.

Unfortunately, the evidence base for the harms and benefits of cervical screening after age 65 is almost nonexistent – at least by the current standards of evidence-based medicine.

“We need to be clear that we don’t really know the appropriateness of the screening after 65,” said Dr. Sawaya, “which is ironic, because cervical cancer screening is probably the most commonly implemented cancer screening test in the country because it starts so early and ends so late and it’s applied so frequently.”

Dr. Feldman agrees that the age 65 cutoff is “somewhat arbitrary.” She said, “Why don’t they want to consider it continuing past 65? I don’t really understand, I have to be honest with you.”

So what’s the scientific evidence backing up the 27-year-old recommendation?

In 2018, the USPSTF’s cervical-screening guidelines concluded “with moderate certainty that the benefits of screening in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer do not outweigh the potential harms.”

This recommendation was based on a new decision model commissioned by the USPSTF. The model was needed because, as noted by the guidelines’ authors, “None of the screening trials enrolled women older than 65 years, so direct evidence on when to stop screening is not available.”

In 2020, the ACS carried out a fresh literature review and published its own recommendations. The ACS concluded that “the evidence for the effectiveness of screening beyond age 65 is limited, based solely on observational and modeling studies.”

As a result, the ACS assigned a “qualified recommendation” to the age-65 moratorium (defined as “less certainty about the balance of benefits and harms or about patients’ values and preferences”).

Most recently, the 2021 Updated Cervical Cancer Screening Guidelines, published by the American College of Obstetricians and Gynecologists, endorsed the recommendations of the USPSTF.

Dr. Sawaya said, “The whole issue about screening over 65 is complicated from a lot of perspectives. We don’t know a lot about the safety. We don’t really know a lot about patients’ perceptions of it. But we do know that there has to be an upper age limit after which screening is just simply imprudent.”

Dr. Sawaya acknowledges that there exists a “heck-why-not” attitude toward cervical screening after 65 among some physicians, given that the tests are quick and cheap and could save a life, but he sounds a note of caution.

“It’s like when we used to use old cameras: the film was cheap, but the developing was really expensive,” Dr. Sawaya said. “So it’s not necessarily about the tests being cheap, it’s about the cascade of events [that follow].”

Follow-up for cervical cancer can be more hazardous for a postmenopausal patient than for a younger woman, explained Dr. Sawaya, because the transformation zone of the cervix may be difficult to see on colposcopy. Instead of a straightforward 5-minute procedure in the doctor’s office, the older patient may need the operating room simply to provide the first biopsy.

In addition, treatments such as cone biopsy, loop excision, or ablation are also more worrying for older women, said Dr. Sawaya, “So you start thinking about the risks of anesthesia, you start thinking about the risks of bleeding and infection, etc. And these have not been well described in older people.”

To add to the uncertainty about the merits and risks of hunting out cervical cancer in older women, a lot has changed in women’s health since 1996.

Explained Dr. Sawaya, “This stake was put in the ground in 1996, ... but since that time, life expectancy has gained 5 years. So a logical person would say, ‘Oh, well, let’s just say it should be 70 now, right?’ [But] can we even use old studies to inform the current cohort of women who are entering this 65-year-and-older age group?”

To answer all these questions, a 5-year, $3.3 million study funded by the NIH through the National Cancer Institute is now underway.

The project, named Comparative Effectiveness Research to Validate and Improve Cervical Cancer Screening (CERVICCS 2), will be led by Dr. Sawaya and Michael Silverberg, PhD, associate director of the Behavioral Health, Aging and Infectious Diseases Section of Kaiser Permanente Northern California’s Division of Research.

Dr. Sawaya concluded: “There’s very few things that are packaged away and thought to be just the truth. And this is why we always have to be vigilant. ... And that’s what keeps science so interesting and exciting.”

Dr. Sawaya has disclosed no relevant financial relationships. Dr. Feldman writes for UpToDate and receives several NIH grants.

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

“Did you love your wife?” asks a character in “Rose,” a book by Martin Cruz Smith.

“No, but she became a fact through perseverance,” the man replied.

Medicine also has such relationships, it seems – tentative ideas that turned into fact simply by existing long enough.

Age 65 as the cutoff for cervical screening may be one such example. It has existed for 27 years with limited science to back it up. That may soon change with the launch of a $3.3 million study that is being funded by the National Institutes of Health (NIH). The study is intended to provide a more solid foundation for the benefits and harms of cervical screening for women older than 65.

It’s an important issue: 20% of all cervical cancer cases are found in women who are older than 65. Most of these patients have late-stage disease, which can be fatal. In the United States, 35% of cervical cancer deaths occur after age 65. But women in this age group are usually no longer screened for cervical cancer.

Back in 1996, the U.S. Preventive Services Task Force recommended that for women at average risk with adequate prior screening, cervical screening should stop at the age of 65. This recommendation has been carried forward year after year and has been incorporated into several other guidelines.

For example, current guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the USPSTF recommend that cervical screening stop at aged 65 for patients with adequate prior screening.

“Adequate screening” is defined as three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative co-tests within the prior 10 years, with the most recent screening within 5 years and with no precancerous lesions in the past 25 years.

This all sounds reasonable; however, for most women, medical records aren’t up to the task of providing a clean bill of cervical health over many decades.

Explained Sarah Feldman, MD, an associate professor in obstetrics, gynecology, and reproductive biology at Harvard Medical School, Boston: “You know, when a patient says to me at 65, ‘Should I continue screening?’ I say, ‘Do you have all your results?’ And they’ll say, ‘Well, I remember I had a sort of abnormal pap 15 years ago,’ and I say, ‘All right; well, who knows what that was?’ So I’ll continue screening.”

According to George Sawaya, MD, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, up to 60% of women do not meet the criteria to end screening at age 65. This means that each year in the United States, approximately 1.7 million women turn 65 and should, in theory, continue to undergo screening for cervical cancer.

Unfortunately, the evidence base for the harms and benefits of cervical screening after age 65 is almost nonexistent – at least by the current standards of evidence-based medicine.

“We need to be clear that we don’t really know the appropriateness of the screening after 65,” said Dr. Sawaya, “which is ironic, because cervical cancer screening is probably the most commonly implemented cancer screening test in the country because it starts so early and ends so late and it’s applied so frequently.”

Dr. Feldman agrees that the age 65 cutoff is “somewhat arbitrary.” She said, “Why don’t they want to consider it continuing past 65? I don’t really understand, I have to be honest with you.”

So what’s the scientific evidence backing up the 27-year-old recommendation?

In 2018, the USPSTF’s cervical-screening guidelines concluded “with moderate certainty that the benefits of screening in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer do not outweigh the potential harms.”

This recommendation was based on a new decision model commissioned by the USPSTF. The model was needed because, as noted by the guidelines’ authors, “None of the screening trials enrolled women older than 65 years, so direct evidence on when to stop screening is not available.”

In 2020, the ACS carried out a fresh literature review and published its own recommendations. The ACS concluded that “the evidence for the effectiveness of screening beyond age 65 is limited, based solely on observational and modeling studies.”

As a result, the ACS assigned a “qualified recommendation” to the age-65 moratorium (defined as “less certainty about the balance of benefits and harms or about patients’ values and preferences”).

Most recently, the 2021 Updated Cervical Cancer Screening Guidelines, published by the American College of Obstetricians and Gynecologists, endorsed the recommendations of the USPSTF.

Dr. Sawaya said, “The whole issue about screening over 65 is complicated from a lot of perspectives. We don’t know a lot about the safety. We don’t really know a lot about patients’ perceptions of it. But we do know that there has to be an upper age limit after which screening is just simply imprudent.”

Dr. Sawaya acknowledges that there exists a “heck-why-not” attitude toward cervical screening after 65 among some physicians, given that the tests are quick and cheap and could save a life, but he sounds a note of caution.

“It’s like when we used to use old cameras: the film was cheap, but the developing was really expensive,” Dr. Sawaya said. “So it’s not necessarily about the tests being cheap, it’s about the cascade of events [that follow].”

Follow-up for cervical cancer can be more hazardous for a postmenopausal patient than for a younger woman, explained Dr. Sawaya, because the transformation zone of the cervix may be difficult to see on colposcopy. Instead of a straightforward 5-minute procedure in the doctor’s office, the older patient may need the operating room simply to provide the first biopsy.

In addition, treatments such as cone biopsy, loop excision, or ablation are also more worrying for older women, said Dr. Sawaya, “So you start thinking about the risks of anesthesia, you start thinking about the risks of bleeding and infection, etc. And these have not been well described in older people.”

To add to the uncertainty about the merits and risks of hunting out cervical cancer in older women, a lot has changed in women’s health since 1996.

Explained Dr. Sawaya, “This stake was put in the ground in 1996, ... but since that time, life expectancy has gained 5 years. So a logical person would say, ‘Oh, well, let’s just say it should be 70 now, right?’ [But] can we even use old studies to inform the current cohort of women who are entering this 65-year-and-older age group?”

To answer all these questions, a 5-year, $3.3 million study funded by the NIH through the National Cancer Institute is now underway.

The project, named Comparative Effectiveness Research to Validate and Improve Cervical Cancer Screening (CERVICCS 2), will be led by Dr. Sawaya and Michael Silverberg, PhD, associate director of the Behavioral Health, Aging and Infectious Diseases Section of Kaiser Permanente Northern California’s Division of Research.

Dr. Sawaya concluded: “There’s very few things that are packaged away and thought to be just the truth. And this is why we always have to be vigilant. ... And that’s what keeps science so interesting and exciting.”

Dr. Sawaya has disclosed no relevant financial relationships. Dr. Feldman writes for UpToDate and receives several NIH grants.

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