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What did you learn in med school that you disagree with now?
Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.
Treat appropriately for pain
Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.
“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”
Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”
Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.
“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
Practice lifestyle and preventive medicine
Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.
“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.
Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.
“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.
Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
Patient care is at the core of medicine
Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.
“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”
But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.
“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”
Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.
“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
Physician, heal thyself
Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”
Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
Practice with gender at the forefront
Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.
“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”
Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.
“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.
“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
Talk about racial disparities
John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.
“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”
Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.
“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
Information at your fingertips
For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.
“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”
A version of this article first appeared on Medscape.com.
Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.
Treat appropriately for pain
Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.
“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”
Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”
Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.
“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
Practice lifestyle and preventive medicine
Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.
“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.
Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.
“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.
Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
Patient care is at the core of medicine
Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.
“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”
But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.
“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”
Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.
“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
Physician, heal thyself
Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”
Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
Practice with gender at the forefront
Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.
“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”
Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.
“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.
“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
Talk about racial disparities
John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.
“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”
Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.
“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
Information at your fingertips
For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.
“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”
A version of this article first appeared on Medscape.com.
Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.
Treat appropriately for pain
Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.
“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”
Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”
Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.
“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
Practice lifestyle and preventive medicine
Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.
“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.
Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.
“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.
Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
Patient care is at the core of medicine
Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.
“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”
But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.
“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”
Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.
“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
Physician, heal thyself
Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”
Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
Practice with gender at the forefront
Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.
“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”
Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.
“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.
“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
Talk about racial disparities
John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.
“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”
Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.
“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
Information at your fingertips
For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.
“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”
A version of this article first appeared on Medscape.com.
It may be time to pay attention to COVID again
More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles.
Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July.
A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation.
Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
Cause for concern?
The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn.
“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”
So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”
While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.
So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
What the official numbers say
The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.
But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000.
“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle.
“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.”
For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing.
So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited.
It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States.
In terms of other metrics:
- On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%.
- On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown.
- The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.
What about new COVID vaccines?
As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter.
“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University.
In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”
Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”
Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September.
His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.”
Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”
Stay alert and stay realistic
Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said.
“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”
A version of this article first appeared on WebMD.com.
More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles.
Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July.
A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation.
Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
Cause for concern?
The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn.
“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”
So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”
While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.
So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
What the official numbers say
The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.
But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000.
“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle.
“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.”
For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing.
So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited.
It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States.
In terms of other metrics:
- On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%.
- On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown.
- The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.
What about new COVID vaccines?
As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter.
“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University.
In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”
Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”
Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September.
His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.”
Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”
Stay alert and stay realistic
Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said.
“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”
A version of this article first appeared on WebMD.com.
More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles.
Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July.
A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation.
Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
Cause for concern?
The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn.
“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”
So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”
While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.
So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
What the official numbers say
The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.
But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000.
“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle.
“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.”
For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing.
So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited.
It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States.
In terms of other metrics:
- On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%.
- On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown.
- The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.
What about new COVID vaccines?
As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter.
“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University.
In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”
Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”
Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September.
His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.”
Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”
Stay alert and stay realistic
Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said.
“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”
A version of this article first appeared on WebMD.com.
Drug name confusion: More than 80 new drug pairs added to the list
Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.
ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.
The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.
Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
Confusing drug names: Ongoing issue
The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.
“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.
According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.
Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
Updated list: A closer look
Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.
Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
Beyond the list
While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.
Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.
Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.
Use both brand and generic names on labels and prescriptions.
Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.
Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.
Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.
Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.
Access the list. The entire list is on the ISMP site and is accessible after free registration.
Goal: Preventing confusion
The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)
The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
Liability update
The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.
These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.
A version of this article first appeared on Medscape.com.
Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.
ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.
The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.
Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
Confusing drug names: Ongoing issue
The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.
“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.
According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.
Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
Updated list: A closer look
Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.
Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
Beyond the list
While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.
Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.
Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.
Use both brand and generic names on labels and prescriptions.
Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.
Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.
Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.
Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.
Access the list. The entire list is on the ISMP site and is accessible after free registration.
Goal: Preventing confusion
The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)
The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
Liability update
The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.
These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.
A version of this article first appeared on Medscape.com.
Zolpidem (Ambien) is a well-known sedative for sleep. Letairis (Ambrisentan) is a vasodilator for the treatment of pulmonary arterial hypertension. Citalopram (Celexa) is an antidepressant; escitalopram (Lexapro) is prescribed for anxiety and depression.
Awareness of these drug names, however, is just the first step in preventing medication mistakes. Health care providers should take a number of other steps as well, experts said.
ISMP launched its confusing drug names list, previously called look-alike, sound-alike (LASA) drugs, in 2008. The new list is an update of the 2019 version, said Michael J. Gaunt, PharmD, senior manager of error reporting programs for the ISMP, which focuses on the prevention of medication mistakes. The new entries were chosen on the basis of a number of factors, including ISMP’s analysis of recent medication mishap reports that were submitted to it.
The ISMP list now includes about 528 drug pairs, Dr. Gaunt said. The list is long, he said, partly because each pair is listed twice, so readers can cross reference. For instance, hydralazine and hydroxyzine are listed in one entry in the list, and hydroxyzine and hydralazine are listed in another.
Brand Institute in Miami has named, among other drugs, Entresto, Rybelsus, and Lunesta. The regulatory arm of the company, the Drug Safety Institute, “considers drug names that have been confused as an important part of our comprehensive drug name assessments,” Todd Bridges, global president of the institute, said in an emailed statement. Information on the confusing drug names are incorporated into the company’s proprietary algorithm and is used when developing brand names for drugs. “We continually update this algorithm as new drug names that are often confused are identified,” Mr. Bridges said.
Confusing drug names: Ongoing issue
The length of the list, as well as the latest additions, are not surprising, said Mary Ann Kliethermes, PharmD, director of medication safety and quality for the American Society of Health-System Pharmacists, a membership organization of about 60,000 pharmacists who practice in inpatient and outpatient settings.
“I’ve been in practice over 45 years,” she said, “and this has been a problem ever since I have been in practice.” The sheer volume of new drugs is one reason, she said. From 2013 through 2022, the U.S. Food and Drug Administration approved an average of 43 novel drugs per year, according to a report from its Center for Drug Evaluation and Research. “Since the 90s, this [confusion about similar drug names] has happened,” Dr. Kliethermes said.
According to a 2023 report, about 7,000-9,000 people die each year in the United States as the result of a medication error. However, it’s impossible to say for sure what percentage of those errors involve name confusion, Dr. Gaunt said.
Not all the mistakes are reported. Some that are reported are dramatic and deadly. In 2022, a Tennessee nurse was convicted of gross neglect and negligent homicide. She was sentenced to 3 years’ probation after she mistakenly gave vercuronium, an anesthetic agent, instead of the sedative Versed to a patient, and the woman died.
Updated list: A closer look
Many of the new drug pairs that are listed in the update are cephalosporins, said Dr. Kliethermes, who reviewed the new list for this news organization. In all, 20 of the latest 82 additions are cephalosporins. These include drugs such as cefazolin, which can be confused with cefotetan, and vice versa. These drugs have been around since the 1980s, she said, but “they needed to be on there.” Even in the 1980s, it was becoming difficult to differentiate them, and there were fewer drugs in that class then, she said.
Influenza vaccines made the new list, too. Fluzone High-Dose Quadrivalent can be confused with fluzone quadrivalent. Other new additions: hydrochlorothiazide and hydroxychloroquine, Lasik and Wakix, Pitressin and Pitocin, Remeron and Rozerem.
Beyond the list
While it’s not possible to pinpoint how big a problem name confusion is in causing medication mistakes, “it is certainly still an issue,” Dr. Gaunt said. A variety of practices can reduce that risk substantially, Dr. Gaunt and Dr. Kliethermes agreed.
Tall-man lettering. Both the FDA and the ISMP recommend the use of so-called tall-man lettering (TML), which involves the use of uppercase letters, sometimes in boldface, to distinguish similar names on product labels and elsewhere. Examples include vinBLAStine and vinCRIStine.
Electronic prescribing. “It eliminates the risk of handwriting confusion,” Dr. Gaunt said. However, electronic prescribing can have a downside, Dr. Kliethermes said. When ordering medication, a person may type in a few letters and may then be presented with a prompt that lists several drug names, and it can be easy to click the wrong one. For that reason, ISMP and other experts recommend typing at least five letters when searching for a medication in an electronic system.
Use both brand and generic names on labels and prescriptions.
Write the indication. That can serve as a double check. If a prescription for Ambien says “For sleep,” there’s probably less risk of filling a prescription for ambrisentan, the vasodilator.
Smart formulary additions. When hospitals add medications to their formularies, “part of that formulary assessment should include looking at the potential risk for errors,” Dr. Gaunt said. This involves keeping an eye out for confusing names and similar packaging. “Do that analysis up front and put in strategies to minimize that. Maybe you look for a different drug [for the same use] that has a different name.” Or choose a different manufacturer, so the medication would at least have a different container.
Use bar code scanning. Suppose a pharmacist goes to the shelf and pulls the wrong drug. “Bar code scanning provides the opportunity to catch the error,” Dr. Gaunt said. Many community pharmacies now have bar code scanning. ISMP just issued best practices for community pharmacies, Dr. Gaunt said, and these include the use of bar code scanning and other measures.
Educate consumers. Health care providers can educate consumers on how to minimize the risk of getting the wrong drug, Dr. Gaunt said. When patients are picking up a prescription, suggest they look at the container label; if it looks different from previous prescriptions of the same medicine, ask the pharmacist for an explanation. Some patients just pass it off, Dr. Gaunt said, figuring the pharmacist or health plan switched manufacturers of their medication.
Access the list. The entire list is on the ISMP site and is accessible after free registration.
Goal: Preventing confusion
The FDA has provided guidance for industry on naming drugs not yet approved so that the proposed names are not too similar in sound or appearance to those already on the market. Included in the lengthy document are checklists, such as, “Across a range of dialects, are the names consistently pronounced differently?” and “Are the lengths of the names dissimilar when scripted?” (Lengths are considered different if they differ by two or more letters.)
The FDA also offers the phonetic and orthographic computer analysis (POCA) program, a software tool that employs an advanced algorithm to evaluate similarities between two drug names. The data sources are updated regularly as new drugs are approved.
Liability update
The problem may be decreasing. In a 2020 report, researchers used pharmacists’ professional liability claim data from the Healthcare Providers Service Organization. They compared 2018 data on claims with 2013 data. The percentage of claims associated with wrong drug dispensing errors declined from 43.8% in 2013 to 36.8% in 2018. Wrong dose claims also declined, from 31.5% to 15.3%.
These researchers concluded that technology and automation have contributed to the prevention of medication errors caused by the use of the wrong drug and the wrong dose, but mistakes continue, owing to system and human errors.
A version of this article first appeared on Medscape.com.
U.S. has new dominant COVID variant called EG.5
Called “Eris” among avid COVID trackers, the strain EG.5 now accounts for 17% of all U.S. COVID infections, according to the latest Centers for Disease Control and Prevention estimates. That’s up from 12% the week prior.
EG.5 has been rising worldwide, just weeks after the World Health Organization added the strain to its official monitoring list. In the United Kingdom, it now accounts for 1 in 10 COVID cases, The Independent reported.
EG.5 is a descendant of the XBB strains that have dominated tracking lists in recent months. It has the same makeup as XBB.1.9.2 but carries an extra spike mutation, according to a summary published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The spike protein is the part of the virus that allows it to enter human cells. But there’s no indication so far that EG.5 is more contagious or severe than other recent variants, according to the CIDRAP summary and a recent podcast from the American Medical Association. The CDC said that current vaccines protect against the variant.
U.S. hospitals saw a 12% increase in COVID admissions during the week ending on July 22, with 8,047 people being admitted because of the virus, up from an all-time low of 6,306 the week of June 24. In 17 states, the past-week increase in hospitalizations was 20% or greater. In Minnesota, the rate jumped by 50%, and in West Virginia, it jumped by 63%. Meanwhile, deaths reached their lowest weekly rate ever for the week of data ending July 29, with just 176 deaths reported by the CDC.
A version of this article first appeared on WebMD.com.
Called “Eris” among avid COVID trackers, the strain EG.5 now accounts for 17% of all U.S. COVID infections, according to the latest Centers for Disease Control and Prevention estimates. That’s up from 12% the week prior.
EG.5 has been rising worldwide, just weeks after the World Health Organization added the strain to its official monitoring list. In the United Kingdom, it now accounts for 1 in 10 COVID cases, The Independent reported.
EG.5 is a descendant of the XBB strains that have dominated tracking lists in recent months. It has the same makeup as XBB.1.9.2 but carries an extra spike mutation, according to a summary published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The spike protein is the part of the virus that allows it to enter human cells. But there’s no indication so far that EG.5 is more contagious or severe than other recent variants, according to the CIDRAP summary and a recent podcast from the American Medical Association. The CDC said that current vaccines protect against the variant.
U.S. hospitals saw a 12% increase in COVID admissions during the week ending on July 22, with 8,047 people being admitted because of the virus, up from an all-time low of 6,306 the week of June 24. In 17 states, the past-week increase in hospitalizations was 20% or greater. In Minnesota, the rate jumped by 50%, and in West Virginia, it jumped by 63%. Meanwhile, deaths reached their lowest weekly rate ever for the week of data ending July 29, with just 176 deaths reported by the CDC.
A version of this article first appeared on WebMD.com.
Called “Eris” among avid COVID trackers, the strain EG.5 now accounts for 17% of all U.S. COVID infections, according to the latest Centers for Disease Control and Prevention estimates. That’s up from 12% the week prior.
EG.5 has been rising worldwide, just weeks after the World Health Organization added the strain to its official monitoring list. In the United Kingdom, it now accounts for 1 in 10 COVID cases, The Independent reported.
EG.5 is a descendant of the XBB strains that have dominated tracking lists in recent months. It has the same makeup as XBB.1.9.2 but carries an extra spike mutation, according to a summary published by the Center for Infectious Disease Research and Policy at the University of Minnesota. The spike protein is the part of the virus that allows it to enter human cells. But there’s no indication so far that EG.5 is more contagious or severe than other recent variants, according to the CIDRAP summary and a recent podcast from the American Medical Association. The CDC said that current vaccines protect against the variant.
U.S. hospitals saw a 12% increase in COVID admissions during the week ending on July 22, with 8,047 people being admitted because of the virus, up from an all-time low of 6,306 the week of June 24. In 17 states, the past-week increase in hospitalizations was 20% or greater. In Minnesota, the rate jumped by 50%, and in West Virginia, it jumped by 63%. Meanwhile, deaths reached their lowest weekly rate ever for the week of data ending July 29, with just 176 deaths reported by the CDC.
A version of this article first appeared on WebMD.com.
Should we rename obesity?
Public perception of disease is everything. “Diabetics” are now referred to as “people living with diabetes,” and an “obese person” is now an “individual living with obesity.”
Despite so much hinging on the word “obesity,” it’s remarkable that the label persists while the concepts underpinning it have evolved significantly. So perhaps it is more about finding the least-worst option rather than pursuing the impossibility of a solution that suits all?
This is precisely the challenge faced by a Lancet Diabetes & Endocrinology Commission on the Definition and Diagnosis of Clinical Obesity, which is due to publish its initial findings this coming fall. The global task force has 60 leaders in the clinical management of obesity, including representatives with lived experiences of obesity. Leading the project is Francesco Rubino, MD, chair of metabolic and bariatric surgery at King’s College London.
“Renaming ‘obesity’ is very important,” states Dr. Rubino. “The word is so stigmatized, with so much misunderstanding and misperception, some might say the only solution is to change the name.”
One possibility for a new name, introduced by the American Association of Clinical Endocrinologists (now –Endocrinology) and the American College of Endocrinology back in 2016, was based on framing the disease on the central characteristic of adiposity and was termed ABCD, for adiposity-based chronic disease.
Dr. Rubino welcomes “ABCD” but has some reservations. “It is good from a physiological point of view, but the problem is it speaks to scientists and medical professionals. I don’t know how much it would appeal to the general public. ‘ABCD’ still falls short of telling us what the illness is.”
He adds that the Lancet Commission’s approach is rather to call it “clinical obesity.” “ ‘Obesity’ itself doesn’t necessarily convey the message that you have a disease or an illness,” he observes. “It is similar to the difference in meaning between depression and clinical depression, which communicate two different things.”
But underpinning any renaming is greater clarification of the definition and diagnosis of obesity. In 1997, the World Health Organization recognized obesity as a chronic disease; in 2013, the American Medical Association did likewise, adding that it warranted medical attention; while it took until 2021 for the European Commission to define obesity as a “chronic relapsing disease, which in turn acts as a gateway to a range of other non-communicable diseases.”
Yet, 25 years after the initial recognition of obesity as a disease, the concept is still riddled with negativity, whether openly or unconsciously. Such stigma denigrates overweight people and those with obesity as “lazy, sloppy, unintelligent, and unattractive.”
Dr. Rubino explains that first, it’s important to establish and define the essential components and characteristics of the disease of obesity. This is key to improving access to clinical care, reducing personal blame, and nurturing a more supportive research environment to help inform both clinical and policy decision-making.
“This is the question that is at the core of our commission. We have a problem with the current definition of obesity, and the way we measure it does not allow us to accurately define a state of illness with obesity,” he explains.
Labels shape public perceptions of disease; ‘obesity’ epitomizes this
Another expert championing the need for a name that better reflects the definition – whatever that turns out to be – is Margaret Steele, PhD, School of Public Health, University College Cork (Ireland), who, according to her university webpage, has a special interest in “ ‘fatness’ as a cultural, social and political phenomenon.”
She believes that labels, including “obesity,” have a pivotal role in shaping public perceptions. In our digital, information-rich age, the boundaries of medicine and society overlap, with public perception shaping decisions of a medical nature as never before. But with this comes controversy and division – obesity management being a case in point.
Specifically, the word “obesity” is too widely associated with negative connotations, she says, and therefore she welcomes the dialogue around redefining and renaming it. Despite wide general support for a name and definition that reflects adiposity, due to its central physiologic role in the complications of obesity, Dr. Steele believes that the “effects on adipose tissue are downstream of brain issues and the food environment,” and she wants to see more attention brought to this.
Referring to most Westernized societies, she describes how people who grew up in times of food scarcity, before processed foods became widely available, have a different taste profile from those who grew up afterwards. “Growing up in 1940s and ‘50s Ireland, people recall how they remember getting an orange as a treat at Christmas, because the idea that you could have food all year-round – any fruit and veg that you want, when you want it – just wasn’t there.”
By comparison, societal changes leading to more financial and time pressure in later decades meant that fast, high-fat, high-sugar, and processed foods became more desirable, she points out. “Most young children now recognize the company name, and even the specific fast-food brand [they like], before they know their alphabet.”
The current environment has cultivated “a very different physical reaction to foods, maybe a different kind of emotional response,” she believes, highlighting the tightly woven relationship between obesity, society, mental health, and food options.
Dr. Steele wants to stimulate a conversation about the term used to describe individuals, conventionally described as ‘”obese” or using the word “obesity.” “We’re thinking in terms of maybe chronic appetite, chronic food intake, or dietary intake dysregulation.”
Changing medical terminology when it has become useless or harmful is not new, she argues, with co-author, Francis Finucane, MD, consultant endocrinologist at Galway University Hospitals, Ireland, in a recent paper on the subject.
“In the 20th century, the terms ‘feeble-minded’ and ‘moron’ had become used in a pejorative way in the wider culture and were dropped from medical usage,” Dr. Steele points out. She adds that changing the term “obesity” can facilitate pursuit of the strategic goals of clinical medicine “without causing needless controversy with those who, given their own goals and contexts, understand body mass index or body weight in a radically different way.”
Obesity: Disease, risk factor, or both?
Dr. Rubino stresses that prior to any renaming, there is a need to establish and define the essential components and characteristics of the disease of obesity. “This question is at the core of our Commission, and it is not an easy conversation to have.” He further explains that the struggle with the current definition of obesity, and the way it is conceived, is largely centered on it still being considered a risk factor for something else.
Disease is characterized by three things, says Dr. Rubino. These comprise the phenomenon of having a pathogenic cause, leading to pathophysiologic alterations (of the organs), causing clinical manifestations.
He adds that obesity is currently described by what it can cause – for example, type 2 diabetes, cancer, or hypertension. “Each of these things have their own clinical manifestations but obesity doesn’t. [As a disease], we don’t have a definition of the clinical manifestations of obesity other than excess adiposity.”
“If we use BMI, this does not predict excess adiposity, nor does it determine a disease here and now. There is no disease without an illness, which is the clinical manifestation, and the perception by the patient of it being an illness,” explains Dr. Rubino, pointing out that the Lancet Commission is filling this gap in knowledge by asking, “If obesity is an illness, then what does it look like?”
He adds that waist circumference probably provides a better measure than BMI in directly indicating the abnormal distribution of adiposity, known to be associated with poor cardiometabolic outcomes, “but it doesn’t tell you if you have an illness here and now – only that someone is at risk of developing cardiovascular disease in the future. Most people with some excess fat around the waist are perfectly functional and don’t feel ill.”
He also explains that confusion persists around whether obesity – or excess adiposity – is a risk factor for or a symptom of another disease. “The picture is blurred, and we do not know how to discriminate between these. We only have one name, and it applies to all those things, and we have one criterion – BMI – to diagnose it!”
Dr. Rubino adds, “So, what defines it? Is it diabetes? No, because that is another disease. You don’t define a disease by another. It has to stand on its own.”
Recently, the American Medical Association advised that BMI now be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.
Aayush Visaria, MD, an internal medicine resident at Rutgers University, New Brunswick, New Jersey, agrees that a new name might help change public perception of obesity for the better. A study he presented at the 2023 Endocrine Society Meeting found that BMI “vastly underestimates” obesity.
He agrees with Dr. Rubino that the challenge lies in the lack of precise understanding of the mechanisms driving obesity: “It’s multifactorial, so not just appetite or food intake. Putting this into one phrase is difficult.”
However, if a new term can incorporate the many facets of the disease, “overall, it’ll reduce stigma because we’ll start to think about obesity as a disease process, not a personal thing with blame attached,” says Dr. Visaria.
But simultaneously, he expresses caution around possible negative connotations associated with the classification of obesity as a disease. Dr. Steele also reflects on this risk, highlighting that medicalizing body size can be counterproductive in feeding into weight stigma and fatphobia.
“Medicalizing obesity can be discouraging rather than empowering, but by specifying more clearly that we’re talking about a specific set of interrelated metabolic conditions, it would make it much clearer, and that ... this isn’t about making people skinny, it isn’t about an aesthetic thing,” Dr. Steele observes.
The word ‘obesity’ hinders disease explanations
Dr. Steele explains that her goal is to overcome the ambiguity around the word “obesity” that hinders explanations of the disease of obesity to the wider public.
“Much confusion and controversy might be avoided if we were to clarify that when doctors say that obesity is a disease, they do not mean that being ‘fat’ is a disease.”
Nevertheless, adipose tissue is an active endocrine organ, producing hormones that function less well in people with obesity, she notes. “This new knowledge has led to better treatments, including drugs like semaglutide and tirzepatide. These drugs, like bariatric surgery, typically lead to significant weight loss and to improvements in overall metabolic health.”
Dr. Rubino also expresses concerns around medicalization, as determined by definition and diagnosis and the availability of drug treatment that could potentially lead to overtreatment. “Currently, when everyone with a BMI of greater than 30 gets access to every obesity treatment out there, we see drugs are running out of stock. We should prioritize that treatment.”
Ultimately, the diagnosis of obesity as a disease needs an anthropometric biomarker that provides, on an individual level, the confidence that a person has a disease today, or at least close to a 100% likelihood of developing this disease and illness, asserts Dr. Rubino.
“If we use BMI, or even waist circumference, these might diagnose the disease; but if the person lives to 90 years, what’s the point of labeling somebody as having an illness?” he points out.
“As doctors, we have to be cautious. We say this is a disease, but you must think about the implications for the person on the receiving end of that diagnosis of a chronic disease that is substantially incurable. When we say it, we need to be certain.”
Dr. Steele and Dr. Visaria have disclosed no relevant financial relationships. Dr. Rubino disclosed that he has received research grants from Novo Nordisk, Medtronic, and Johnson & Johnson. He has undertaken paid consultancy work for GI Dynamics and received honoraria for lectures from Medtronic, Novo Nordisk, and Johnson & Johnson. He is a member of the data safety monitoring board for GT Metabolic Solutions and has provided scientific advice to Keyron, Metadeq, GHP Scientific, and ViBo Health for no remuneration.
A version of this article first appeared on Medscape.com.
Public perception of disease is everything. “Diabetics” are now referred to as “people living with diabetes,” and an “obese person” is now an “individual living with obesity.”
Despite so much hinging on the word “obesity,” it’s remarkable that the label persists while the concepts underpinning it have evolved significantly. So perhaps it is more about finding the least-worst option rather than pursuing the impossibility of a solution that suits all?
This is precisely the challenge faced by a Lancet Diabetes & Endocrinology Commission on the Definition and Diagnosis of Clinical Obesity, which is due to publish its initial findings this coming fall. The global task force has 60 leaders in the clinical management of obesity, including representatives with lived experiences of obesity. Leading the project is Francesco Rubino, MD, chair of metabolic and bariatric surgery at King’s College London.
“Renaming ‘obesity’ is very important,” states Dr. Rubino. “The word is so stigmatized, with so much misunderstanding and misperception, some might say the only solution is to change the name.”
One possibility for a new name, introduced by the American Association of Clinical Endocrinologists (now –Endocrinology) and the American College of Endocrinology back in 2016, was based on framing the disease on the central characteristic of adiposity and was termed ABCD, for adiposity-based chronic disease.
Dr. Rubino welcomes “ABCD” but has some reservations. “It is good from a physiological point of view, but the problem is it speaks to scientists and medical professionals. I don’t know how much it would appeal to the general public. ‘ABCD’ still falls short of telling us what the illness is.”
He adds that the Lancet Commission’s approach is rather to call it “clinical obesity.” “ ‘Obesity’ itself doesn’t necessarily convey the message that you have a disease or an illness,” he observes. “It is similar to the difference in meaning between depression and clinical depression, which communicate two different things.”
But underpinning any renaming is greater clarification of the definition and diagnosis of obesity. In 1997, the World Health Organization recognized obesity as a chronic disease; in 2013, the American Medical Association did likewise, adding that it warranted medical attention; while it took until 2021 for the European Commission to define obesity as a “chronic relapsing disease, which in turn acts as a gateway to a range of other non-communicable diseases.”
Yet, 25 years after the initial recognition of obesity as a disease, the concept is still riddled with negativity, whether openly or unconsciously. Such stigma denigrates overweight people and those with obesity as “lazy, sloppy, unintelligent, and unattractive.”
Dr. Rubino explains that first, it’s important to establish and define the essential components and characteristics of the disease of obesity. This is key to improving access to clinical care, reducing personal blame, and nurturing a more supportive research environment to help inform both clinical and policy decision-making.
“This is the question that is at the core of our commission. We have a problem with the current definition of obesity, and the way we measure it does not allow us to accurately define a state of illness with obesity,” he explains.
Labels shape public perceptions of disease; ‘obesity’ epitomizes this
Another expert championing the need for a name that better reflects the definition – whatever that turns out to be – is Margaret Steele, PhD, School of Public Health, University College Cork (Ireland), who, according to her university webpage, has a special interest in “ ‘fatness’ as a cultural, social and political phenomenon.”
She believes that labels, including “obesity,” have a pivotal role in shaping public perceptions. In our digital, information-rich age, the boundaries of medicine and society overlap, with public perception shaping decisions of a medical nature as never before. But with this comes controversy and division – obesity management being a case in point.
Specifically, the word “obesity” is too widely associated with negative connotations, she says, and therefore she welcomes the dialogue around redefining and renaming it. Despite wide general support for a name and definition that reflects adiposity, due to its central physiologic role in the complications of obesity, Dr. Steele believes that the “effects on adipose tissue are downstream of brain issues and the food environment,” and she wants to see more attention brought to this.
Referring to most Westernized societies, she describes how people who grew up in times of food scarcity, before processed foods became widely available, have a different taste profile from those who grew up afterwards. “Growing up in 1940s and ‘50s Ireland, people recall how they remember getting an orange as a treat at Christmas, because the idea that you could have food all year-round – any fruit and veg that you want, when you want it – just wasn’t there.”
By comparison, societal changes leading to more financial and time pressure in later decades meant that fast, high-fat, high-sugar, and processed foods became more desirable, she points out. “Most young children now recognize the company name, and even the specific fast-food brand [they like], before they know their alphabet.”
The current environment has cultivated “a very different physical reaction to foods, maybe a different kind of emotional response,” she believes, highlighting the tightly woven relationship between obesity, society, mental health, and food options.
Dr. Steele wants to stimulate a conversation about the term used to describe individuals, conventionally described as ‘”obese” or using the word “obesity.” “We’re thinking in terms of maybe chronic appetite, chronic food intake, or dietary intake dysregulation.”
Changing medical terminology when it has become useless or harmful is not new, she argues, with co-author, Francis Finucane, MD, consultant endocrinologist at Galway University Hospitals, Ireland, in a recent paper on the subject.
“In the 20th century, the terms ‘feeble-minded’ and ‘moron’ had become used in a pejorative way in the wider culture and were dropped from medical usage,” Dr. Steele points out. She adds that changing the term “obesity” can facilitate pursuit of the strategic goals of clinical medicine “without causing needless controversy with those who, given their own goals and contexts, understand body mass index or body weight in a radically different way.”
Obesity: Disease, risk factor, or both?
Dr. Rubino stresses that prior to any renaming, there is a need to establish and define the essential components and characteristics of the disease of obesity. “This question is at the core of our Commission, and it is not an easy conversation to have.” He further explains that the struggle with the current definition of obesity, and the way it is conceived, is largely centered on it still being considered a risk factor for something else.
Disease is characterized by three things, says Dr. Rubino. These comprise the phenomenon of having a pathogenic cause, leading to pathophysiologic alterations (of the organs), causing clinical manifestations.
He adds that obesity is currently described by what it can cause – for example, type 2 diabetes, cancer, or hypertension. “Each of these things have their own clinical manifestations but obesity doesn’t. [As a disease], we don’t have a definition of the clinical manifestations of obesity other than excess adiposity.”
“If we use BMI, this does not predict excess adiposity, nor does it determine a disease here and now. There is no disease without an illness, which is the clinical manifestation, and the perception by the patient of it being an illness,” explains Dr. Rubino, pointing out that the Lancet Commission is filling this gap in knowledge by asking, “If obesity is an illness, then what does it look like?”
He adds that waist circumference probably provides a better measure than BMI in directly indicating the abnormal distribution of adiposity, known to be associated with poor cardiometabolic outcomes, “but it doesn’t tell you if you have an illness here and now – only that someone is at risk of developing cardiovascular disease in the future. Most people with some excess fat around the waist are perfectly functional and don’t feel ill.”
He also explains that confusion persists around whether obesity – or excess adiposity – is a risk factor for or a symptom of another disease. “The picture is blurred, and we do not know how to discriminate between these. We only have one name, and it applies to all those things, and we have one criterion – BMI – to diagnose it!”
Dr. Rubino adds, “So, what defines it? Is it diabetes? No, because that is another disease. You don’t define a disease by another. It has to stand on its own.”
Recently, the American Medical Association advised that BMI now be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.
Aayush Visaria, MD, an internal medicine resident at Rutgers University, New Brunswick, New Jersey, agrees that a new name might help change public perception of obesity for the better. A study he presented at the 2023 Endocrine Society Meeting found that BMI “vastly underestimates” obesity.
He agrees with Dr. Rubino that the challenge lies in the lack of precise understanding of the mechanisms driving obesity: “It’s multifactorial, so not just appetite or food intake. Putting this into one phrase is difficult.”
However, if a new term can incorporate the many facets of the disease, “overall, it’ll reduce stigma because we’ll start to think about obesity as a disease process, not a personal thing with blame attached,” says Dr. Visaria.
But simultaneously, he expresses caution around possible negative connotations associated with the classification of obesity as a disease. Dr. Steele also reflects on this risk, highlighting that medicalizing body size can be counterproductive in feeding into weight stigma and fatphobia.
“Medicalizing obesity can be discouraging rather than empowering, but by specifying more clearly that we’re talking about a specific set of interrelated metabolic conditions, it would make it much clearer, and that ... this isn’t about making people skinny, it isn’t about an aesthetic thing,” Dr. Steele observes.
The word ‘obesity’ hinders disease explanations
Dr. Steele explains that her goal is to overcome the ambiguity around the word “obesity” that hinders explanations of the disease of obesity to the wider public.
“Much confusion and controversy might be avoided if we were to clarify that when doctors say that obesity is a disease, they do not mean that being ‘fat’ is a disease.”
Nevertheless, adipose tissue is an active endocrine organ, producing hormones that function less well in people with obesity, she notes. “This new knowledge has led to better treatments, including drugs like semaglutide and tirzepatide. These drugs, like bariatric surgery, typically lead to significant weight loss and to improvements in overall metabolic health.”
Dr. Rubino also expresses concerns around medicalization, as determined by definition and diagnosis and the availability of drug treatment that could potentially lead to overtreatment. “Currently, when everyone with a BMI of greater than 30 gets access to every obesity treatment out there, we see drugs are running out of stock. We should prioritize that treatment.”
Ultimately, the diagnosis of obesity as a disease needs an anthropometric biomarker that provides, on an individual level, the confidence that a person has a disease today, or at least close to a 100% likelihood of developing this disease and illness, asserts Dr. Rubino.
“If we use BMI, or even waist circumference, these might diagnose the disease; but if the person lives to 90 years, what’s the point of labeling somebody as having an illness?” he points out.
“As doctors, we have to be cautious. We say this is a disease, but you must think about the implications for the person on the receiving end of that diagnosis of a chronic disease that is substantially incurable. When we say it, we need to be certain.”
Dr. Steele and Dr. Visaria have disclosed no relevant financial relationships. Dr. Rubino disclosed that he has received research grants from Novo Nordisk, Medtronic, and Johnson & Johnson. He has undertaken paid consultancy work for GI Dynamics and received honoraria for lectures from Medtronic, Novo Nordisk, and Johnson & Johnson. He is a member of the data safety monitoring board for GT Metabolic Solutions and has provided scientific advice to Keyron, Metadeq, GHP Scientific, and ViBo Health for no remuneration.
A version of this article first appeared on Medscape.com.
Public perception of disease is everything. “Diabetics” are now referred to as “people living with diabetes,” and an “obese person” is now an “individual living with obesity.”
Despite so much hinging on the word “obesity,” it’s remarkable that the label persists while the concepts underpinning it have evolved significantly. So perhaps it is more about finding the least-worst option rather than pursuing the impossibility of a solution that suits all?
This is precisely the challenge faced by a Lancet Diabetes & Endocrinology Commission on the Definition and Diagnosis of Clinical Obesity, which is due to publish its initial findings this coming fall. The global task force has 60 leaders in the clinical management of obesity, including representatives with lived experiences of obesity. Leading the project is Francesco Rubino, MD, chair of metabolic and bariatric surgery at King’s College London.
“Renaming ‘obesity’ is very important,” states Dr. Rubino. “The word is so stigmatized, with so much misunderstanding and misperception, some might say the only solution is to change the name.”
One possibility for a new name, introduced by the American Association of Clinical Endocrinologists (now –Endocrinology) and the American College of Endocrinology back in 2016, was based on framing the disease on the central characteristic of adiposity and was termed ABCD, for adiposity-based chronic disease.
Dr. Rubino welcomes “ABCD” but has some reservations. “It is good from a physiological point of view, but the problem is it speaks to scientists and medical professionals. I don’t know how much it would appeal to the general public. ‘ABCD’ still falls short of telling us what the illness is.”
He adds that the Lancet Commission’s approach is rather to call it “clinical obesity.” “ ‘Obesity’ itself doesn’t necessarily convey the message that you have a disease or an illness,” he observes. “It is similar to the difference in meaning between depression and clinical depression, which communicate two different things.”
But underpinning any renaming is greater clarification of the definition and diagnosis of obesity. In 1997, the World Health Organization recognized obesity as a chronic disease; in 2013, the American Medical Association did likewise, adding that it warranted medical attention; while it took until 2021 for the European Commission to define obesity as a “chronic relapsing disease, which in turn acts as a gateway to a range of other non-communicable diseases.”
Yet, 25 years after the initial recognition of obesity as a disease, the concept is still riddled with negativity, whether openly or unconsciously. Such stigma denigrates overweight people and those with obesity as “lazy, sloppy, unintelligent, and unattractive.”
Dr. Rubino explains that first, it’s important to establish and define the essential components and characteristics of the disease of obesity. This is key to improving access to clinical care, reducing personal blame, and nurturing a more supportive research environment to help inform both clinical and policy decision-making.
“This is the question that is at the core of our commission. We have a problem with the current definition of obesity, and the way we measure it does not allow us to accurately define a state of illness with obesity,” he explains.
Labels shape public perceptions of disease; ‘obesity’ epitomizes this
Another expert championing the need for a name that better reflects the definition – whatever that turns out to be – is Margaret Steele, PhD, School of Public Health, University College Cork (Ireland), who, according to her university webpage, has a special interest in “ ‘fatness’ as a cultural, social and political phenomenon.”
She believes that labels, including “obesity,” have a pivotal role in shaping public perceptions. In our digital, information-rich age, the boundaries of medicine and society overlap, with public perception shaping decisions of a medical nature as never before. But with this comes controversy and division – obesity management being a case in point.
Specifically, the word “obesity” is too widely associated with negative connotations, she says, and therefore she welcomes the dialogue around redefining and renaming it. Despite wide general support for a name and definition that reflects adiposity, due to its central physiologic role in the complications of obesity, Dr. Steele believes that the “effects on adipose tissue are downstream of brain issues and the food environment,” and she wants to see more attention brought to this.
Referring to most Westernized societies, she describes how people who grew up in times of food scarcity, before processed foods became widely available, have a different taste profile from those who grew up afterwards. “Growing up in 1940s and ‘50s Ireland, people recall how they remember getting an orange as a treat at Christmas, because the idea that you could have food all year-round – any fruit and veg that you want, when you want it – just wasn’t there.”
By comparison, societal changes leading to more financial and time pressure in later decades meant that fast, high-fat, high-sugar, and processed foods became more desirable, she points out. “Most young children now recognize the company name, and even the specific fast-food brand [they like], before they know their alphabet.”
The current environment has cultivated “a very different physical reaction to foods, maybe a different kind of emotional response,” she believes, highlighting the tightly woven relationship between obesity, society, mental health, and food options.
Dr. Steele wants to stimulate a conversation about the term used to describe individuals, conventionally described as ‘”obese” or using the word “obesity.” “We’re thinking in terms of maybe chronic appetite, chronic food intake, or dietary intake dysregulation.”
Changing medical terminology when it has become useless or harmful is not new, she argues, with co-author, Francis Finucane, MD, consultant endocrinologist at Galway University Hospitals, Ireland, in a recent paper on the subject.
“In the 20th century, the terms ‘feeble-minded’ and ‘moron’ had become used in a pejorative way in the wider culture and were dropped from medical usage,” Dr. Steele points out. She adds that changing the term “obesity” can facilitate pursuit of the strategic goals of clinical medicine “without causing needless controversy with those who, given their own goals and contexts, understand body mass index or body weight in a radically different way.”
Obesity: Disease, risk factor, or both?
Dr. Rubino stresses that prior to any renaming, there is a need to establish and define the essential components and characteristics of the disease of obesity. “This question is at the core of our Commission, and it is not an easy conversation to have.” He further explains that the struggle with the current definition of obesity, and the way it is conceived, is largely centered on it still being considered a risk factor for something else.
Disease is characterized by three things, says Dr. Rubino. These comprise the phenomenon of having a pathogenic cause, leading to pathophysiologic alterations (of the organs), causing clinical manifestations.
He adds that obesity is currently described by what it can cause – for example, type 2 diabetes, cancer, or hypertension. “Each of these things have their own clinical manifestations but obesity doesn’t. [As a disease], we don’t have a definition of the clinical manifestations of obesity other than excess adiposity.”
“If we use BMI, this does not predict excess adiposity, nor does it determine a disease here and now. There is no disease without an illness, which is the clinical manifestation, and the perception by the patient of it being an illness,” explains Dr. Rubino, pointing out that the Lancet Commission is filling this gap in knowledge by asking, “If obesity is an illness, then what does it look like?”
He adds that waist circumference probably provides a better measure than BMI in directly indicating the abnormal distribution of adiposity, known to be associated with poor cardiometabolic outcomes, “but it doesn’t tell you if you have an illness here and now – only that someone is at risk of developing cardiovascular disease in the future. Most people with some excess fat around the waist are perfectly functional and don’t feel ill.”
He also explains that confusion persists around whether obesity – or excess adiposity – is a risk factor for or a symptom of another disease. “The picture is blurred, and we do not know how to discriminate between these. We only have one name, and it applies to all those things, and we have one criterion – BMI – to diagnose it!”
Dr. Rubino adds, “So, what defines it? Is it diabetes? No, because that is another disease. You don’t define a disease by another. It has to stand on its own.”
Recently, the American Medical Association advised that BMI now be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.
Aayush Visaria, MD, an internal medicine resident at Rutgers University, New Brunswick, New Jersey, agrees that a new name might help change public perception of obesity for the better. A study he presented at the 2023 Endocrine Society Meeting found that BMI “vastly underestimates” obesity.
He agrees with Dr. Rubino that the challenge lies in the lack of precise understanding of the mechanisms driving obesity: “It’s multifactorial, so not just appetite or food intake. Putting this into one phrase is difficult.”
However, if a new term can incorporate the many facets of the disease, “overall, it’ll reduce stigma because we’ll start to think about obesity as a disease process, not a personal thing with blame attached,” says Dr. Visaria.
But simultaneously, he expresses caution around possible negative connotations associated with the classification of obesity as a disease. Dr. Steele also reflects on this risk, highlighting that medicalizing body size can be counterproductive in feeding into weight stigma and fatphobia.
“Medicalizing obesity can be discouraging rather than empowering, but by specifying more clearly that we’re talking about a specific set of interrelated metabolic conditions, it would make it much clearer, and that ... this isn’t about making people skinny, it isn’t about an aesthetic thing,” Dr. Steele observes.
The word ‘obesity’ hinders disease explanations
Dr. Steele explains that her goal is to overcome the ambiguity around the word “obesity” that hinders explanations of the disease of obesity to the wider public.
“Much confusion and controversy might be avoided if we were to clarify that when doctors say that obesity is a disease, they do not mean that being ‘fat’ is a disease.”
Nevertheless, adipose tissue is an active endocrine organ, producing hormones that function less well in people with obesity, she notes. “This new knowledge has led to better treatments, including drugs like semaglutide and tirzepatide. These drugs, like bariatric surgery, typically lead to significant weight loss and to improvements in overall metabolic health.”
Dr. Rubino also expresses concerns around medicalization, as determined by definition and diagnosis and the availability of drug treatment that could potentially lead to overtreatment. “Currently, when everyone with a BMI of greater than 30 gets access to every obesity treatment out there, we see drugs are running out of stock. We should prioritize that treatment.”
Ultimately, the diagnosis of obesity as a disease needs an anthropometric biomarker that provides, on an individual level, the confidence that a person has a disease today, or at least close to a 100% likelihood of developing this disease and illness, asserts Dr. Rubino.
“If we use BMI, or even waist circumference, these might diagnose the disease; but if the person lives to 90 years, what’s the point of labeling somebody as having an illness?” he points out.
“As doctors, we have to be cautious. We say this is a disease, but you must think about the implications for the person on the receiving end of that diagnosis of a chronic disease that is substantially incurable. When we say it, we need to be certain.”
Dr. Steele and Dr. Visaria have disclosed no relevant financial relationships. Dr. Rubino disclosed that he has received research grants from Novo Nordisk, Medtronic, and Johnson & Johnson. He has undertaken paid consultancy work for GI Dynamics and received honoraria for lectures from Medtronic, Novo Nordisk, and Johnson & Johnson. He is a member of the data safety monitoring board for GT Metabolic Solutions and has provided scientific advice to Keyron, Metadeq, GHP Scientific, and ViBo Health for no remuneration.
A version of this article first appeared on Medscape.com.
OxyContin marketing push still exacting a deadly toll, study says
The uptick in rates of infectious diseases, namely, hepatitis and infective endocarditis, occurred after 2010, when OxyContin maker Purdue Pharma reformulated OxyContin to make it harder to crush and snort. This led many people who were already addicted to the powerful pain pills to move on to injecting heroin or fentanyl, which fueled the spread of infectious disease.
“Our results suggest that the mortality and morbidity consequences of OxyContin marketing continue to be salient more than 25 years later,” write Julia Dennett, PhD, and Gregg Gonsalves, PhD, with Yale University School of Public Health, New Haven, Conn.
Their study was published online in Health Affairs.
Long-term effects revealed
Until now, the long-term effects of widespread OxyContin marketing with regard to complications of injection drug use were unknown.
Dr. Dennett and Dr. Gonsalves evaluated the effects of OxyContin marketing on the long-term trajectories of various injection drug use–related outcomes. Using a difference-in-difference analysis, they compared states with high vs. low exposure to OxyContin marketing before and after the 2010 reformulation of the drug.
Before 2010, rates of infections associated with injection drug use and overdose deaths were similar in high- and low-marketing states, they found.
Those rates diverged after the 2010 reformulation, with more infections related to injection drug use in states exposed to more marketing.
Specifically, from 2010 until 2020, high-exposure states saw, on average, an additional 0.85 acute hepatitis B cases, 0.83 hepatitis C cases, and 0.62 cases of death from infective endocarditis per 100,000 residents.
High-exposure states also had 5.3 more deaths per 100,000 residents from synthetic opioid overdose.
“Prior to 2010, among these states, there were generally no statistically significant differences in these outcomes. After 2010, you saw them diverge dramatically,” Dr. Dennett said in a news release.
Dr. Dennett and Dr. Gonsalves say their findings support the view that the opioid epidemic is creating a converging public health crisis, as it is fueling a surge in infectious diseases, particularly hepatitis, infective endocarditis, and HIV.
“This study highlights a critical need for actions to address the spread of viral and bacterial infections and overdose associated with injection drug use, both in the states that were subject to Purdue’s promotional campaign and across the U.S. more broadly,” they add.
Purdue Pharma did not provide a comment on the study.
Funding for the study was provided by the National Institute on Drug Abuse. Disclosures for Dr. Dennett and Dr. Gonsalves were not available.
A version of this article first appeared on Medscape.com.
The uptick in rates of infectious diseases, namely, hepatitis and infective endocarditis, occurred after 2010, when OxyContin maker Purdue Pharma reformulated OxyContin to make it harder to crush and snort. This led many people who were already addicted to the powerful pain pills to move on to injecting heroin or fentanyl, which fueled the spread of infectious disease.
“Our results suggest that the mortality and morbidity consequences of OxyContin marketing continue to be salient more than 25 years later,” write Julia Dennett, PhD, and Gregg Gonsalves, PhD, with Yale University School of Public Health, New Haven, Conn.
Their study was published online in Health Affairs.
Long-term effects revealed
Until now, the long-term effects of widespread OxyContin marketing with regard to complications of injection drug use were unknown.
Dr. Dennett and Dr. Gonsalves evaluated the effects of OxyContin marketing on the long-term trajectories of various injection drug use–related outcomes. Using a difference-in-difference analysis, they compared states with high vs. low exposure to OxyContin marketing before and after the 2010 reformulation of the drug.
Before 2010, rates of infections associated with injection drug use and overdose deaths were similar in high- and low-marketing states, they found.
Those rates diverged after the 2010 reformulation, with more infections related to injection drug use in states exposed to more marketing.
Specifically, from 2010 until 2020, high-exposure states saw, on average, an additional 0.85 acute hepatitis B cases, 0.83 hepatitis C cases, and 0.62 cases of death from infective endocarditis per 100,000 residents.
High-exposure states also had 5.3 more deaths per 100,000 residents from synthetic opioid overdose.
“Prior to 2010, among these states, there were generally no statistically significant differences in these outcomes. After 2010, you saw them diverge dramatically,” Dr. Dennett said in a news release.
Dr. Dennett and Dr. Gonsalves say their findings support the view that the opioid epidemic is creating a converging public health crisis, as it is fueling a surge in infectious diseases, particularly hepatitis, infective endocarditis, and HIV.
“This study highlights a critical need for actions to address the spread of viral and bacterial infections and overdose associated with injection drug use, both in the states that were subject to Purdue’s promotional campaign and across the U.S. more broadly,” they add.
Purdue Pharma did not provide a comment on the study.
Funding for the study was provided by the National Institute on Drug Abuse. Disclosures for Dr. Dennett and Dr. Gonsalves were not available.
A version of this article first appeared on Medscape.com.
The uptick in rates of infectious diseases, namely, hepatitis and infective endocarditis, occurred after 2010, when OxyContin maker Purdue Pharma reformulated OxyContin to make it harder to crush and snort. This led many people who were already addicted to the powerful pain pills to move on to injecting heroin or fentanyl, which fueled the spread of infectious disease.
“Our results suggest that the mortality and morbidity consequences of OxyContin marketing continue to be salient more than 25 years later,” write Julia Dennett, PhD, and Gregg Gonsalves, PhD, with Yale University School of Public Health, New Haven, Conn.
Their study was published online in Health Affairs.
Long-term effects revealed
Until now, the long-term effects of widespread OxyContin marketing with regard to complications of injection drug use were unknown.
Dr. Dennett and Dr. Gonsalves evaluated the effects of OxyContin marketing on the long-term trajectories of various injection drug use–related outcomes. Using a difference-in-difference analysis, they compared states with high vs. low exposure to OxyContin marketing before and after the 2010 reformulation of the drug.
Before 2010, rates of infections associated with injection drug use and overdose deaths were similar in high- and low-marketing states, they found.
Those rates diverged after the 2010 reformulation, with more infections related to injection drug use in states exposed to more marketing.
Specifically, from 2010 until 2020, high-exposure states saw, on average, an additional 0.85 acute hepatitis B cases, 0.83 hepatitis C cases, and 0.62 cases of death from infective endocarditis per 100,000 residents.
High-exposure states also had 5.3 more deaths per 100,000 residents from synthetic opioid overdose.
“Prior to 2010, among these states, there were generally no statistically significant differences in these outcomes. After 2010, you saw them diverge dramatically,” Dr. Dennett said in a news release.
Dr. Dennett and Dr. Gonsalves say their findings support the view that the opioid epidemic is creating a converging public health crisis, as it is fueling a surge in infectious diseases, particularly hepatitis, infective endocarditis, and HIV.
“This study highlights a critical need for actions to address the spread of viral and bacterial infections and overdose associated with injection drug use, both in the states that were subject to Purdue’s promotional campaign and across the U.S. more broadly,” they add.
Purdue Pharma did not provide a comment on the study.
Funding for the study was provided by the National Institute on Drug Abuse. Disclosures for Dr. Dennett and Dr. Gonsalves were not available.
A version of this article first appeared on Medscape.com.
FROM HEALTH AFFAIRS
Cigna accused of using AI, not doctors, to deny claims: Lawsuit
and forcing providers to bill patients in full.
In a complaint filed recently in California’s eastern district court, plaintiffs and Cigna health plan members Suzanne Kisting-Leung and Ayesha Smiley and their attorneys say that Cigna violates state insurance regulations by failing to conduct a “thorough, fair, and objective” review of their and other members’ claims.
The lawsuit says that, instead, Cigna relies on an algorithm, PxDx, to review and frequently deny medically necessary claims. According to court records, the system allows Cigna’s doctors to “instantly reject claims on medical grounds without ever opening patient files.” With use of the system, the average claims processing time is 1.2 seconds.
Cigna says it uses technology to verify coding on standard, low-cost procedures and to expedite physician reimbursement. In a statement to CBS News, the company called the lawsuit “highly questionable.”
The case highlights growing concerns about AI and its ability to replace humans for tasks and interactions in health care, business, and beyond. Public advocacy law firm Clarkson, which is representing the plaintiffs, has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ personal and professional data to train their AI systems.
According to the complaint, Cigna denied the plaintiffs medically necessary tests, including blood work to screen for vitamin D deficiency and ultrasounds for patients suspected of having ovarian cancer. The plaintiffs’ attempts to appeal were unfruitful, and they were forced to pay out of pocket.
The plaintiff’s attorneys argue that the claims do not undergo more detailed reviews by physicians and employees, as mandated by California insurance laws, and that Cigna benefits by saving on labor costs.
Clarkson is demanding a jury trial and has asked the court to certify the Cigna case as a federal class action, potentially allowing the insurer’s other 2 million health plan members in California to join the lawsuit.
I. Glenn Cohen, JD, deputy dean and professor at Harvard Law School, Cambridge, Mass., said in an interview that this is the first lawsuit he’s aware of in which AI was involved in denying health insurance claims and that it is probably an uphill battle for the plaintiffs.
“In the last 25 years, the U.S. Supreme Court’s decisions have made getting a class action approved more difficult. If allowed to go forward as a class action, which Cigna is likely to vigorously oppose, then the pressure on Cigna to settle the case becomes enormous,” he said.
The allegations come after a recent deep dive by the nonprofit ProPublica uncovered similar claim denial issues. One physician who worked for Cigna told the nonprofit that he and other company doctors essentially rubber-stamped the denials in batches, which took “all of 10 seconds to do 50 at a time.”
In 2022, the American Medical Association and two state physician groups joined another class action against Cigna stemming from allegations that the insurer’s intermediary, Multiplan, intentionally underpaid medical claims. And in March, Cigna’s pharmacy benefit manager, Express Scripts, was accused of conspiring with other PBMs to drive up prescription drug prices for Ohio consumers, violating state antitrust laws.
Mr. Cohen said he expects Cigna to push back in court about the California class size, which the plaintiff’s attorneys hope will encompass all Cigna health plan members in the state.
“The injury is primarily to those whose claims were denied by AI, presumably a much smaller set of individuals and harder to identify,” said Mr. Cohen.
A version of this article first appeared on Medscape.com.
and forcing providers to bill patients in full.
In a complaint filed recently in California’s eastern district court, plaintiffs and Cigna health plan members Suzanne Kisting-Leung and Ayesha Smiley and their attorneys say that Cigna violates state insurance regulations by failing to conduct a “thorough, fair, and objective” review of their and other members’ claims.
The lawsuit says that, instead, Cigna relies on an algorithm, PxDx, to review and frequently deny medically necessary claims. According to court records, the system allows Cigna’s doctors to “instantly reject claims on medical grounds without ever opening patient files.” With use of the system, the average claims processing time is 1.2 seconds.
Cigna says it uses technology to verify coding on standard, low-cost procedures and to expedite physician reimbursement. In a statement to CBS News, the company called the lawsuit “highly questionable.”
The case highlights growing concerns about AI and its ability to replace humans for tasks and interactions in health care, business, and beyond. Public advocacy law firm Clarkson, which is representing the plaintiffs, has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ personal and professional data to train their AI systems.
According to the complaint, Cigna denied the plaintiffs medically necessary tests, including blood work to screen for vitamin D deficiency and ultrasounds for patients suspected of having ovarian cancer. The plaintiffs’ attempts to appeal were unfruitful, and they were forced to pay out of pocket.
The plaintiff’s attorneys argue that the claims do not undergo more detailed reviews by physicians and employees, as mandated by California insurance laws, and that Cigna benefits by saving on labor costs.
Clarkson is demanding a jury trial and has asked the court to certify the Cigna case as a federal class action, potentially allowing the insurer’s other 2 million health plan members in California to join the lawsuit.
I. Glenn Cohen, JD, deputy dean and professor at Harvard Law School, Cambridge, Mass., said in an interview that this is the first lawsuit he’s aware of in which AI was involved in denying health insurance claims and that it is probably an uphill battle for the plaintiffs.
“In the last 25 years, the U.S. Supreme Court’s decisions have made getting a class action approved more difficult. If allowed to go forward as a class action, which Cigna is likely to vigorously oppose, then the pressure on Cigna to settle the case becomes enormous,” he said.
The allegations come after a recent deep dive by the nonprofit ProPublica uncovered similar claim denial issues. One physician who worked for Cigna told the nonprofit that he and other company doctors essentially rubber-stamped the denials in batches, which took “all of 10 seconds to do 50 at a time.”
In 2022, the American Medical Association and two state physician groups joined another class action against Cigna stemming from allegations that the insurer’s intermediary, Multiplan, intentionally underpaid medical claims. And in March, Cigna’s pharmacy benefit manager, Express Scripts, was accused of conspiring with other PBMs to drive up prescription drug prices for Ohio consumers, violating state antitrust laws.
Mr. Cohen said he expects Cigna to push back in court about the California class size, which the plaintiff’s attorneys hope will encompass all Cigna health plan members in the state.
“The injury is primarily to those whose claims were denied by AI, presumably a much smaller set of individuals and harder to identify,” said Mr. Cohen.
A version of this article first appeared on Medscape.com.
and forcing providers to bill patients in full.
In a complaint filed recently in California’s eastern district court, plaintiffs and Cigna health plan members Suzanne Kisting-Leung and Ayesha Smiley and their attorneys say that Cigna violates state insurance regulations by failing to conduct a “thorough, fair, and objective” review of their and other members’ claims.
The lawsuit says that, instead, Cigna relies on an algorithm, PxDx, to review and frequently deny medically necessary claims. According to court records, the system allows Cigna’s doctors to “instantly reject claims on medical grounds without ever opening patient files.” With use of the system, the average claims processing time is 1.2 seconds.
Cigna says it uses technology to verify coding on standard, low-cost procedures and to expedite physician reimbursement. In a statement to CBS News, the company called the lawsuit “highly questionable.”
The case highlights growing concerns about AI and its ability to replace humans for tasks and interactions in health care, business, and beyond. Public advocacy law firm Clarkson, which is representing the plaintiffs, has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ personal and professional data to train their AI systems.
According to the complaint, Cigna denied the plaintiffs medically necessary tests, including blood work to screen for vitamin D deficiency and ultrasounds for patients suspected of having ovarian cancer. The plaintiffs’ attempts to appeal were unfruitful, and they were forced to pay out of pocket.
The plaintiff’s attorneys argue that the claims do not undergo more detailed reviews by physicians and employees, as mandated by California insurance laws, and that Cigna benefits by saving on labor costs.
Clarkson is demanding a jury trial and has asked the court to certify the Cigna case as a federal class action, potentially allowing the insurer’s other 2 million health plan members in California to join the lawsuit.
I. Glenn Cohen, JD, deputy dean and professor at Harvard Law School, Cambridge, Mass., said in an interview that this is the first lawsuit he’s aware of in which AI was involved in denying health insurance claims and that it is probably an uphill battle for the plaintiffs.
“In the last 25 years, the U.S. Supreme Court’s decisions have made getting a class action approved more difficult. If allowed to go forward as a class action, which Cigna is likely to vigorously oppose, then the pressure on Cigna to settle the case becomes enormous,” he said.
The allegations come after a recent deep dive by the nonprofit ProPublica uncovered similar claim denial issues. One physician who worked for Cigna told the nonprofit that he and other company doctors essentially rubber-stamped the denials in batches, which took “all of 10 seconds to do 50 at a time.”
In 2022, the American Medical Association and two state physician groups joined another class action against Cigna stemming from allegations that the insurer’s intermediary, Multiplan, intentionally underpaid medical claims. And in March, Cigna’s pharmacy benefit manager, Express Scripts, was accused of conspiring with other PBMs to drive up prescription drug prices for Ohio consumers, violating state antitrust laws.
Mr. Cohen said he expects Cigna to push back in court about the California class size, which the plaintiff’s attorneys hope will encompass all Cigna health plan members in the state.
“The injury is primarily to those whose claims were denied by AI, presumably a much smaller set of individuals and harder to identify,” said Mr. Cohen.
A version of this article first appeared on Medscape.com.
Rising viral load on dolutegravir? Investigators try fix before switch
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
AT IAS 2023
Results from halted islatravir antiretroviral trial presented
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Clinicians debate the usefulness of NAFLD name change
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.
Some clinicians say it’s “confusing” and “ridiculous” to change the name and diagnostic criteria of an established liver disease, while others bemoan the seemingly political reasons why it happened. Yet recently, 236 panelists from 56 countries decided that the terms nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) rely on “exclusionary confounder terms and the use of potentially stigmatizing language.”
In a report published in Hepatology, the panelists, members of the NAFLD Nomenclature Consensus Group, determined that steatotic liver disease (SLD) would be used as an “overarching term to encompass the various etiologies of steatosis.”
Metabolic dysfunction–associated steatotic liver disease (MASLD) was chosen to replace NAFLD, and the definition was changed to include at least one of five cardiometabolic risk factors.
Metabolic dysfunction–associated steatohepatitis (MASH) replaces NASH.
Those with no metabolic parameters and no known cause will be diagnosed with cryptogenic SLD.
A new category, MetALD, now describes those with MASLD who drink more alcohol per week – 140-350 g for men and 210-420 g for women.
The changes did not sit well with this news organization’s readers from diverse specialties, including family practice, critical care, and gastroenterology.
In its report, the consensus group wrote that 74% of respondents to its rounds of surveys felt the current nomenclature “was sufficiently flawed to consider a name change.”
The terms “nonalcoholic” and “fatty” were felt to be stigmatizing by 61% and 66% of respondents, respectively, according to the group, a multi-stakeholder effort under the auspices of the American Association for Study of Liver Disease and the European Association for Study of the Liver, in collaboration with the Asociación Latinoamericana para el Estudio del Hígado.
Consensus was defined a priori as a supermajority (67%) vote.
“The new nomenclature and diagnostic criteria are widely supported, nonstigmatizing, and can improve awareness and patient identification,” the group concluded.
“No way” sums up many of the almost 60 reader comments received on this news organization’s story covering the change. Readers must share medical credentials to publicly comment on stories.
‘Confusing’ and ‘ridiculous’
A number of readers questioned how the changes will help practice.
“Once again, the specialists and other experts are changing the nomenclature to make the subject even more confusing for us primary care practitioners,” an HIV/AIDS physician wrote. “They obviously have no idea what [primary care practitioners] have to put up with day in and day out. All such revisions do is increase the cynicism and anger so many [primary care practitioners] have.”
Similarly, an internist said, “These new terms are going to confuse both doctors and patients. When you give a patient a diagnosis like this, they will not understand it, and will not be able to act as they should to correct it.”
“ ‘Fatty liver’ is a jargon-free diagnosis, easy to understand and easy for patients to know what they need to do,” the internist continued. “You think patients are gonna be educated when you tell them they have a ‘metabolic disease’? 100% they will not know what you’re talking about.”
Yet another wondered, “If SLD is the ‘umbrella’ term, why (are) MetALD and ALD not MetASLD and ASLD, respectively? Furthermore, efforts to ‘destigmatize’ terminology will inadvertently condemn cryptogenic SLD (CSLD) as the new ‘closet alcoholic.’ “
“Perhaps a subclassification, CSLD-HDIRDD (CSLD–Honest, Doc, I Really Don’t Drink),” the reader added.
“Everything about this is ridiculous,” a family physician wrote. “How long will it be until the experts change obesity to ‘gravitationally challenged’ as a diagnosis!”
“I was thinking of ‘circumferentially challenged,’” a reader in Canada chimed in. “But that would be ‘body shaming’ would it not?”
This reader continued, asking, “What about returning to the old practice of using Latin names patients don’t understand so there is no ‘shame’ attached to them? Or what about this revolutionary idea: To just say it as it is – fat?”
Acceding to ‘wokeness’
A sizable number of readers felt the name changes were motivated by a “woke” awareness.
“The effect of this new ‘woke’ clarity is ridiculous and simply not worth it! Can we justify the cost of this? Patients will have to learn all over again how to discuss their condition,” said one reader.
The reader continued, saying, “The Internet and social media freely use the term ‘fat’ – and despite not wanting to offend – there seems to be universal agreement that FAT, in certain conditions or places, is unhealthy and undesirable.
“Why is the medical community so afraid to tell it like it is? I might hurt your feelings, but I could save your life,” concluded the reader.
Defending change
One commentator, a hepatologist in France, defended the changes and responded to some of complaints.
“Maybe people who comment here should read the article, reflect, and understand the reasons why the old nomenclature and definition were scientifically inaccurate and needed to be changed,” the commentator wrote.
“It was an exclusionary, negative definition not recognizing the root of the disease (adipose tissue dysfunction with insulin resistance – instead defining it by what it is not ...) and not allowing the recognition of a large segment of the population [that] accumulates metabolic risk factors and moderate alcohol consumption. These patients were left out of all studies. Those were the main reasons for change and not the stigma part – with the word ‘fatty’ only being an issue in English-speaking countries, not elsewhere,” the commentator continued.
“Calls for change have been voiced for 20 years and a first comprehensive attempt (called MAFLD) was introduced 3 years ago (J Hepatol. 2020;73:202-9). Please, a little bit of respect and restraint in the comments recognizing the research efforts and publications for those that contributed to the field over the past 25 years ...” the hepatologist wrote.
The reader added, “Clinicians and researchers were dissatisfied for a long time, but it took years to gather overwhelming evidence demonstrating what causes the disease and then to kickstart a process under the auspices of several multinational scientific societies and come up with something consensually agreed upon by a large number of clinician researchers.
“Now you can tell your patient that he has metabolic liver disease instead of telling him that the problem at the root of his disease is that he is not drinking alcohol (nonalcoholic steatohepatitis). So, again, it is not so much about changing a name but about redefining diagnostic criteria and a nosological framework,” the reader wrote.
Other readers responded to the defender:
“This nomenclature issue has been churned for 20+ years? Well, the mountain has labored heavily, and given birth to a mouse,” one said.
“Still, how is this going to help in the clinical management? The whole gamut of conditions are evaluated and treated as a whole, not in isolation,” a general practitioner in India said. “If someone has a risk factor or not, continuous follow-up is required as a whole, whether it’s nonalcoholic or alcoholic, or whatever term is coined up.”
Finally, a family physician said, “It just rolls off the tongue, doesn’t it? But I have to admit, it’s the one place where ‘persons’ from 56 countries can get together and agree on something. Not even politicians can do that! Me, I’m sticking with NAFLD.”
A version of this article first appeared on Medscape.com.