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New challenge for docs: End of COVID federal public health emergency
The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.
A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.
The result is a patchwork of emergency COVID-19 measures with different end dates.
The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.
Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.
The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”
The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
Patients’ questions
Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).
“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”
Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.
For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.
The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.
“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.
States significantly changed Medicaid policy to expand access to care during the pandemic.
All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.
The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.
In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
The end of free COVID vaccines, testing for some patients
The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.
After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.
But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).
People who don’t have insurance may lose access to COVID testing and vaccines.
“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
Future FDA actions
Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.
But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.
The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.
The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.
The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.
“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.
Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.
“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”
A version of this article first appeared on Medscape.com.
The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.
A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.
The result is a patchwork of emergency COVID-19 measures with different end dates.
The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.
Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.
The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”
The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
Patients’ questions
Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).
“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”
Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.
For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.
The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.
“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.
States significantly changed Medicaid policy to expand access to care during the pandemic.
All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.
The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.
In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
The end of free COVID vaccines, testing for some patients
The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.
After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.
But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).
People who don’t have insurance may lose access to COVID testing and vaccines.
“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
Future FDA actions
Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.
But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.
The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.
The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.
The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.
“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.
Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.
“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”
A version of this article first appeared on Medscape.com.
The Biden administration intends to end by May 11 certain COVID-19 emergency measures used to aid in the response to the pandemic, while many others will remain in place.
A separate declaration covers the Food and Drug Administration’s emergency use authorizations (EUAs) for COVID medicines and tests. That would not be affected by the May 11 deadline, the FDA said. In addition, Congress and state lawmakers have extended some COVID response measures.
The result is a patchwork of emergency COVID-19 measures with different end dates.
The American Medical Association and the American Academy of Family Physicians (AAFP) are assessing how best to advise their members about the end of the public health emergency.
Several waivers regarding copays and coverage and policies regarding controlled substances will expire, Claire Ernst, director of government affairs at the Medical Group Management Association, told this news organization.
The impact of the unwinding “will vary based on some factors, such as what state the practice resides in,” Ms. Ernst said. “Fortunately, Congress provided some predictability for practices by extending many of the telehealth waivers through the end of 2024.”
The AAFP told this news organization that it has joined several other groups in calling for the release of proposed Drug Enforcement Administration (DEA) regulations meant to permanently allow prescriptions of buprenorphine treatment for opioid use disorder via telehealth. The AAFP and other groups want to review these proposals and, if needed, urge the DEA to modify or finalize before there are any disruptions in access to medications for opioid use disorder.
Patients’ questions
Clinicians can expect to field patients’ questions about their insurance coverage and what they need to pay, said Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association (AHA).
“Your doctor’s office, that clinic you typically get care at, that is the face of medicine to you,” Ms. Foster told this news organization. “Many doctors and their staff will be asked, ‘What’s happening with Medicaid?’ ‘What about my Medicare coverage?’ ‘Can I still access care in the same way that I did before?’ ”
Physicians will need to be ready to answers those question, or point patients to where they can get answers, Ms. Foster said.
For example, Medicaid will no longer cover postpartum care for some enrollees after giving birth, said Taylor Platt, health policy manager for the American College of Obstetricians and Gynecologists.
The federal response to the pandemic created “a de facto postpartum coverage extension for Medicaid enrollees,” which will be lost in some states, Ms. Platt told this news organization. However, 28 states and the District of Columbia have taken separate measures to extend postpartum coverage to 1 year.
“This coverage has been critical for postpartum individuals to address health needs like substance use and mental health treatment and chronic conditions,” Ms. Platt said.
States significantly changed Medicaid policy to expand access to care during the pandemic.
All 50 states and the District of Columbia, for example, expanded coverage or access to telehealth services in Medicaid during the pandemic, according to a Jan. 31 report from the Kaiser Family Foundation (KFF). These expansions expire under various deadlines, although most states have made or are planning to make some Medicaid telehealth flexibilities permanent, KFF said.
The KFF report notes that all states and the District of Columbia temporarily waived some aspects of state licensure requirements, so that clinicians with equivalent licenses in other states could practice via telehealth.
In some states, these waivers are still active and are tied to the end of the federal emergency declaration. In others, they expired, with some states allowing for long-term or permanent interstate telemedicine, KFF said. (The Federation of State Medical Boards has a detailed summary of these modifications.)
The end of free COVID vaccines, testing for some patients
The AAFP has also raised concerns about continued access to COVID-19 vaccines, particularly for uninsured adults. Ashish Jha, MD, MPH, the White House COVID-19 Response Coordinator, said in a tweet that this transition, however, wouldn’t happen until a few months after the public health emergency ends.
After those few months, there will be a transition from U.S. government–distributed vaccines and treatments to ones purchased through the regular health care system, the “way we do for every other vaccine and treatment,” Dr. Jha added.
But that raises the same kind of difficult questions that permeate U.S. health care, with a potential to keep COVID active, said Patricia Jackson, RN, president of the Association for Professionals in Infection Control and Epidemiology (APIC).
People who don’t have insurance may lose access to COVID testing and vaccines.
“Will that lead to increases in transmission? Who knows,” Ms. Jackson told this news organization. “We will have to see. There are some health equity issues that potentially arise.”
Future FDA actions
Biden’s May 11 deadline applies to emergency provisions made under a Section 319 declaration, which allow the Department of Health and Human Services to respond to crises.
But a separate flexibility, known as a Section 564 declaration, covers the FDA’s EUAs, which can remain in effect even as the other declarations end.
The best-known EUAs for the pandemic were used to bring COVID vaccines and treatments to market. Many of these have since been converted to normal approvals as companies presented more evidence to support the initial emergency approvals. In other cases, EUAs have been withdrawn owing to disappointing research results, changing virus strains, and evolving medical treatments.
The FDA also used many EUAs to cover new uses of ventilators and other hospital equipment and expand these supplies in response to the pandemic, said Mark Howell, AHA’s director of policy and patient safety.
The FDA should examine the EUAs issued during the pandemic to see what greater flexibilities might be used to deal with future serious shortages of critical supplies. International incidents such as the war in Ukraine show how fragile the supply chain can be. The FDA should consider its recent experience with EUAs to address this, Mr. Howell said.
“What do we do coming out of the pandemic? And how do we think about being more proactive in this space to ensure that our supply doesn’t bottleneck, that we continue to make sure that providers have access to supply that’s not only safe and effective, but that they can use?” Mr. Howell told this news organization.
Such planning might also help prepare the country for the next pandemic, which is a near certainty, APIC’s Ms. Jackson said. The nation needs a nimbler response to the next major outbreak of an infectious disease, she said.
“There is going to be a next time,” Ms. Jackson said. “We are going to have another pandemic.”
A version of this article first appeared on Medscape.com.
The 5-year survival rate for pancreatic cancer is increasing
John Whyte, MD: Hello, I’m Dr. John Whyte, the Chief Medical Officer of WebMD. One of those cancers was pancreatic cancer, which historically has had a very low survival rate. What’s going on here? Are we doing better with diagnosis, treatment, a combination?
Joining me today is Dr. Lynn Matrisian. She is PanCAN’s chief science officer. Dr. Matrisian, thanks for joining me today. It’s great to see you.
Lynn Matrisian, PhD, MBA: Great to be here. Thank you.
Dr. Whyte: Well, tell me what your first reaction was when you saw the recent data from the American Cancer Society. What one word would you use?
Dr. Matrisian: Hopeful. I think hopeful in general that survival rates are increasing, not for all cancers, but for many cancers. We continue to make progress. Research is making a difference. And we’re making progress against cancer in general.
Dr. Whyte: You’re passionate, as our viewers know, about pancreatic cancer. And that’s been one of the hardest cancers to treat, and one of the lowest survival rates. But there’s some encouraging news that we saw, didn’t we?
Dr. Matrisian: Yes. So the 5-year survival rate for pancreatic cancer went up a whole percentage. It’s at 12% now. And what’s really good is it was at 11% last year. It was at 10% the year before. So that’s 2 years in a row that we’ve had an increase in the 5-year survival rate for pancreatic cancer. So we’re hopeful that’s a trajectory that we can really capitalize on is how fast we’re making progress in this disease.
Dr. Whyte: I want to put it into context, Lynn. Because some people might be thinking, 1%? Like you’re excited about 1%? That doesn’t seem that much. But correct me if I’m wrong. A one percentage point increase means 641 more loved ones will enjoy life’s moments, as you put it, 5 years after their diagnosis that otherwise wouldn’t have. What does that practically mean to viewers?
Dr. Matrisian: That means that more than 600 people in the United States will hug a loved one 5 years after that diagnosis of pancreatic cancer. It is a very deadly disease. But we’re going to, by continuing to make progress, it gives those moments to those people. And it means that we’re making progress against the disease in general.
Dr. Whyte: So even 1%, and 1% each year, does have value.
Dr. Matrisian: It has a lot of value.
Dr. Whyte: What’s driving this improvement? Is it better screening? And we’re not so great still in screening a pancreatic cancer. Is it the innovation in cancer treatments? What do you think is accounting for what we hope is this trajectory of increases in 5-year survival?
Dr. Matrisian: Right, so the nice thing the reason that we like looking at 5-year survival rates is because it takes into account all of those things. And we have actually made progress in all of those things. So by looking at those that are diagnosed with pancreatic cancer in general as a whole, and looking at their survival, we are looking at better treatments. People who are getting pancreatic cancer later are living longer as a result of better treatments.
But it’s not just that. It’s also, if you’re diagnosed earlier, your 5-year survival rate is higher. More people who are diagnosed early live to five years than those that are diagnosed later. So within that statistic, there are more people who are diagnosed earlier. And those people also live longer. So it takes into account all of those things, which is why we really like to look at that five-year survival rate for a disease like pancreatic cancer.
Dr. Whyte: Where are we on screening? Because we always want to catch people early. That gives them that greatest chance of survival. Have we made much improvements there? And if we have, what are they?
Dr. Matrisian: Well we have made improvements there are more people that are now diagnosed with localized disease than there were 20 years ago. So that is increasing. And we’re still doing it really by being aware of the symptoms right now. Being aware that kind of chronic indigestion, lower back pain that won’t go away, these are signs and symptoms. And especially things like jaundice ...
Dr. Whyte: That yellow color that they might see.
Dr. Matrisian: Yes, that yellow colors in your eye, that’s a really important symptom that would certainly send people to the doctor in order to look at this. So some of it is being more aware and finding the disease earlier. But what we’re really hoping for is some sort of blood test or some sort of other way of looking through medical records and identifying those people that need to go and be checked.
Dr. Whyte: Now we chatted about that almost two years ago. So tell me the progress that we’ve made. How are we doing?
Dr. Matrisian: Yeah, well there’s a number of companies now that have blood tests that are available. They still need more work. They still need more studies to really understand how good they are at finding pancreatic cancer early. But we didn’t have them a couple of years ago. And so it’s really a very exciting time in the field, that there’s companies that were taking advantage of research for many years and actually turning it into a commercial product that is available for people to check.
Dr. Whyte: And then what about treatments? More treatment options today than there were just a few years ago, but still a lot of progress to be made. So when we talk about even 12% 5-year survival, we’d love to see it much more. And you talk about, I don’t want to misquote, so correct me if I’m wrong. Your goal is 20%. Five-year survival by 2030. That’s not too far. So, Lynn, how are we going to get there?
Dr. Matrisian: Okay, well this is our mission. And that’s exactly our goal, 20% by 2030. So we’ve got some work to do. And we are working at both fronts. You’re right, we need better treatments. And so we’ve set up a clinical trial platform where we can look at a lot of different treatments much more efficiently, much faster, kind of taking advantage of an infrastructure to do that. And that’s called Precision Promise. And we’re excited about that as a way to get new treatments for advanced pancreatic cancer.
And then we’re also working on the early detection end. We think an important symptom of pancreatic cancer that isn’t often recognized is new onset diabetes, sudden diabetes in those over 50 where that person did not have diabetes before. So it’s new, looks like type 2 diabetes, but it’s actually caused by pancreatic cancer.
And so we have an initiative, The Early Detection Initiative, that is taking advantage of that. And seeing if we image people right away based on that symptom, can we find pancreatic cancer early? So we think it’s important to look both at trying to diagnose it earlier, as well as trying to treat it better for advanced disease.
Dr. Whyte: Yeah. You know, at WebMD we’re always trying to empower people with better information so they can also become advocates for their health. You’re an expert in advocacy on pancreatic cancer. So what’s your advice to listeners as to how they become good advocates for themselves or advocates in general for loved ones who have pancreatic cancer?
Dr. Matrisian: Yeah. Yeah. Well certainly, knowledge is power. And so the real thing to do is to call the Pancreatic Cancer Action Network. This is what we do. We stay up on the most current information. We have very experienced case managers who can help navigate the complexities of pancreatic cancer at every stage of the journey.
Or if you have questions about pancreatic cancer, call PanCAN. Go to PanCAN.org and give us a call. Because it’s really that knowledge, knowing what it is that you need to get more knowledge about, how to advocate for yourself is very important in a disease, in any disease, but in particular a disease like pancreatic cancer.
Dr. Whyte: And I don’t want to dismiss the progress that we’ve made, that you’ve just referenced in terms of the increased survival. But there’s still a long way to go. We need a lot more dollars for research. We need a lot more clinical trials to take place. What’s your message to a viewer who’s been diagnosed with pancreatic cancer or a loved one? What’s your message, Lynn, today for them?
Dr. Matrisian: Well, first, get as much knowledge as you can. Call PanCAN, and let us help you help your loved one. But then help us. Let’s do research. Let’s do more research. Let’s understand this disease better so we can make those kinds of progress in both treatment and early detection.
And PanCAN works very hard at understanding the disease and setting up research programs that are going to make a difference, that are going to get us to that aggressive goal of 20% survival by 2030. So there is a lot of things that can be done, raise awareness to your friends and neighbors about the disease, lots of things that will help this whole field.
Dr. Whyte: What’s your feeling on second opinions? Given that this can be a difficult cancer to treat, given that there’s emerging therapies that are always developing, when you have a diagnosis of pancreatic cancer, is it important to consider getting a second opinion?
Dr. Matrisian: Yes. Yes, it is. And our case managers will help with that process. We do think it’s important.
Dr. Whyte: Because sometimes, Lynn, people just want to get started, right? Get it out of me. Get treatment. And sometimes getting a second opinion, doing some genomic testing can take time. So what’s your response to that?
Dr. Matrisian: Yeah. Yeah. Well we say, your care team is very important. Who is on your care team, and it may take a little time to find the right people on your care team. But that is an incredibly important step. Sometimes it’s not just one person. Sometimes you need more than one doctor, more than one nurse, more than one type of specialty to help you deal with this. And taking the time to do that is incredibly important.
Yes, you need to – you do need to act. But act smart. And do it with knowledge. Do it really understanding what your options are, and advocate for yourself.
Dr. Whyte: And surround yourself as you reference with that right care team for you, because that’s the most important thing when you have any type of cancer diagnosis. Dr. Lynn Matrisian, I want to thank you for taking time today.
Dr. Matrisian: Thank you so much, John.
A version of this article first appeared on Medscape.com.
John Whyte, MD: Hello, I’m Dr. John Whyte, the Chief Medical Officer of WebMD. One of those cancers was pancreatic cancer, which historically has had a very low survival rate. What’s going on here? Are we doing better with diagnosis, treatment, a combination?
Joining me today is Dr. Lynn Matrisian. She is PanCAN’s chief science officer. Dr. Matrisian, thanks for joining me today. It’s great to see you.
Lynn Matrisian, PhD, MBA: Great to be here. Thank you.
Dr. Whyte: Well, tell me what your first reaction was when you saw the recent data from the American Cancer Society. What one word would you use?
Dr. Matrisian: Hopeful. I think hopeful in general that survival rates are increasing, not for all cancers, but for many cancers. We continue to make progress. Research is making a difference. And we’re making progress against cancer in general.
Dr. Whyte: You’re passionate, as our viewers know, about pancreatic cancer. And that’s been one of the hardest cancers to treat, and one of the lowest survival rates. But there’s some encouraging news that we saw, didn’t we?
Dr. Matrisian: Yes. So the 5-year survival rate for pancreatic cancer went up a whole percentage. It’s at 12% now. And what’s really good is it was at 11% last year. It was at 10% the year before. So that’s 2 years in a row that we’ve had an increase in the 5-year survival rate for pancreatic cancer. So we’re hopeful that’s a trajectory that we can really capitalize on is how fast we’re making progress in this disease.
Dr. Whyte: I want to put it into context, Lynn. Because some people might be thinking, 1%? Like you’re excited about 1%? That doesn’t seem that much. But correct me if I’m wrong. A one percentage point increase means 641 more loved ones will enjoy life’s moments, as you put it, 5 years after their diagnosis that otherwise wouldn’t have. What does that practically mean to viewers?
Dr. Matrisian: That means that more than 600 people in the United States will hug a loved one 5 years after that diagnosis of pancreatic cancer. It is a very deadly disease. But we’re going to, by continuing to make progress, it gives those moments to those people. And it means that we’re making progress against the disease in general.
Dr. Whyte: So even 1%, and 1% each year, does have value.
Dr. Matrisian: It has a lot of value.
Dr. Whyte: What’s driving this improvement? Is it better screening? And we’re not so great still in screening a pancreatic cancer. Is it the innovation in cancer treatments? What do you think is accounting for what we hope is this trajectory of increases in 5-year survival?
Dr. Matrisian: Right, so the nice thing the reason that we like looking at 5-year survival rates is because it takes into account all of those things. And we have actually made progress in all of those things. So by looking at those that are diagnosed with pancreatic cancer in general as a whole, and looking at their survival, we are looking at better treatments. People who are getting pancreatic cancer later are living longer as a result of better treatments.
But it’s not just that. It’s also, if you’re diagnosed earlier, your 5-year survival rate is higher. More people who are diagnosed early live to five years than those that are diagnosed later. So within that statistic, there are more people who are diagnosed earlier. And those people also live longer. So it takes into account all of those things, which is why we really like to look at that five-year survival rate for a disease like pancreatic cancer.
Dr. Whyte: Where are we on screening? Because we always want to catch people early. That gives them that greatest chance of survival. Have we made much improvements there? And if we have, what are they?
Dr. Matrisian: Well we have made improvements there are more people that are now diagnosed with localized disease than there were 20 years ago. So that is increasing. And we’re still doing it really by being aware of the symptoms right now. Being aware that kind of chronic indigestion, lower back pain that won’t go away, these are signs and symptoms. And especially things like jaundice ...
Dr. Whyte: That yellow color that they might see.
Dr. Matrisian: Yes, that yellow colors in your eye, that’s a really important symptom that would certainly send people to the doctor in order to look at this. So some of it is being more aware and finding the disease earlier. But what we’re really hoping for is some sort of blood test or some sort of other way of looking through medical records and identifying those people that need to go and be checked.
Dr. Whyte: Now we chatted about that almost two years ago. So tell me the progress that we’ve made. How are we doing?
Dr. Matrisian: Yeah, well there’s a number of companies now that have blood tests that are available. They still need more work. They still need more studies to really understand how good they are at finding pancreatic cancer early. But we didn’t have them a couple of years ago. And so it’s really a very exciting time in the field, that there’s companies that were taking advantage of research for many years and actually turning it into a commercial product that is available for people to check.
Dr. Whyte: And then what about treatments? More treatment options today than there were just a few years ago, but still a lot of progress to be made. So when we talk about even 12% 5-year survival, we’d love to see it much more. And you talk about, I don’t want to misquote, so correct me if I’m wrong. Your goal is 20%. Five-year survival by 2030. That’s not too far. So, Lynn, how are we going to get there?
Dr. Matrisian: Okay, well this is our mission. And that’s exactly our goal, 20% by 2030. So we’ve got some work to do. And we are working at both fronts. You’re right, we need better treatments. And so we’ve set up a clinical trial platform where we can look at a lot of different treatments much more efficiently, much faster, kind of taking advantage of an infrastructure to do that. And that’s called Precision Promise. And we’re excited about that as a way to get new treatments for advanced pancreatic cancer.
And then we’re also working on the early detection end. We think an important symptom of pancreatic cancer that isn’t often recognized is new onset diabetes, sudden diabetes in those over 50 where that person did not have diabetes before. So it’s new, looks like type 2 diabetes, but it’s actually caused by pancreatic cancer.
And so we have an initiative, The Early Detection Initiative, that is taking advantage of that. And seeing if we image people right away based on that symptom, can we find pancreatic cancer early? So we think it’s important to look both at trying to diagnose it earlier, as well as trying to treat it better for advanced disease.
Dr. Whyte: Yeah. You know, at WebMD we’re always trying to empower people with better information so they can also become advocates for their health. You’re an expert in advocacy on pancreatic cancer. So what’s your advice to listeners as to how they become good advocates for themselves or advocates in general for loved ones who have pancreatic cancer?
Dr. Matrisian: Yeah. Yeah. Well certainly, knowledge is power. And so the real thing to do is to call the Pancreatic Cancer Action Network. This is what we do. We stay up on the most current information. We have very experienced case managers who can help navigate the complexities of pancreatic cancer at every stage of the journey.
Or if you have questions about pancreatic cancer, call PanCAN. Go to PanCAN.org and give us a call. Because it’s really that knowledge, knowing what it is that you need to get more knowledge about, how to advocate for yourself is very important in a disease, in any disease, but in particular a disease like pancreatic cancer.
Dr. Whyte: And I don’t want to dismiss the progress that we’ve made, that you’ve just referenced in terms of the increased survival. But there’s still a long way to go. We need a lot more dollars for research. We need a lot more clinical trials to take place. What’s your message to a viewer who’s been diagnosed with pancreatic cancer or a loved one? What’s your message, Lynn, today for them?
Dr. Matrisian: Well, first, get as much knowledge as you can. Call PanCAN, and let us help you help your loved one. But then help us. Let’s do research. Let’s do more research. Let’s understand this disease better so we can make those kinds of progress in both treatment and early detection.
And PanCAN works very hard at understanding the disease and setting up research programs that are going to make a difference, that are going to get us to that aggressive goal of 20% survival by 2030. So there is a lot of things that can be done, raise awareness to your friends and neighbors about the disease, lots of things that will help this whole field.
Dr. Whyte: What’s your feeling on second opinions? Given that this can be a difficult cancer to treat, given that there’s emerging therapies that are always developing, when you have a diagnosis of pancreatic cancer, is it important to consider getting a second opinion?
Dr. Matrisian: Yes. Yes, it is. And our case managers will help with that process. We do think it’s important.
Dr. Whyte: Because sometimes, Lynn, people just want to get started, right? Get it out of me. Get treatment. And sometimes getting a second opinion, doing some genomic testing can take time. So what’s your response to that?
Dr. Matrisian: Yeah. Yeah. Well we say, your care team is very important. Who is on your care team, and it may take a little time to find the right people on your care team. But that is an incredibly important step. Sometimes it’s not just one person. Sometimes you need more than one doctor, more than one nurse, more than one type of specialty to help you deal with this. And taking the time to do that is incredibly important.
Yes, you need to – you do need to act. But act smart. And do it with knowledge. Do it really understanding what your options are, and advocate for yourself.
Dr. Whyte: And surround yourself as you reference with that right care team for you, because that’s the most important thing when you have any type of cancer diagnosis. Dr. Lynn Matrisian, I want to thank you for taking time today.
Dr. Matrisian: Thank you so much, John.
A version of this article first appeared on Medscape.com.
John Whyte, MD: Hello, I’m Dr. John Whyte, the Chief Medical Officer of WebMD. One of those cancers was pancreatic cancer, which historically has had a very low survival rate. What’s going on here? Are we doing better with diagnosis, treatment, a combination?
Joining me today is Dr. Lynn Matrisian. She is PanCAN’s chief science officer. Dr. Matrisian, thanks for joining me today. It’s great to see you.
Lynn Matrisian, PhD, MBA: Great to be here. Thank you.
Dr. Whyte: Well, tell me what your first reaction was when you saw the recent data from the American Cancer Society. What one word would you use?
Dr. Matrisian: Hopeful. I think hopeful in general that survival rates are increasing, not for all cancers, but for many cancers. We continue to make progress. Research is making a difference. And we’re making progress against cancer in general.
Dr. Whyte: You’re passionate, as our viewers know, about pancreatic cancer. And that’s been one of the hardest cancers to treat, and one of the lowest survival rates. But there’s some encouraging news that we saw, didn’t we?
Dr. Matrisian: Yes. So the 5-year survival rate for pancreatic cancer went up a whole percentage. It’s at 12% now. And what’s really good is it was at 11% last year. It was at 10% the year before. So that’s 2 years in a row that we’ve had an increase in the 5-year survival rate for pancreatic cancer. So we’re hopeful that’s a trajectory that we can really capitalize on is how fast we’re making progress in this disease.
Dr. Whyte: I want to put it into context, Lynn. Because some people might be thinking, 1%? Like you’re excited about 1%? That doesn’t seem that much. But correct me if I’m wrong. A one percentage point increase means 641 more loved ones will enjoy life’s moments, as you put it, 5 years after their diagnosis that otherwise wouldn’t have. What does that practically mean to viewers?
Dr. Matrisian: That means that more than 600 people in the United States will hug a loved one 5 years after that diagnosis of pancreatic cancer. It is a very deadly disease. But we’re going to, by continuing to make progress, it gives those moments to those people. And it means that we’re making progress against the disease in general.
Dr. Whyte: So even 1%, and 1% each year, does have value.
Dr. Matrisian: It has a lot of value.
Dr. Whyte: What’s driving this improvement? Is it better screening? And we’re not so great still in screening a pancreatic cancer. Is it the innovation in cancer treatments? What do you think is accounting for what we hope is this trajectory of increases in 5-year survival?
Dr. Matrisian: Right, so the nice thing the reason that we like looking at 5-year survival rates is because it takes into account all of those things. And we have actually made progress in all of those things. So by looking at those that are diagnosed with pancreatic cancer in general as a whole, and looking at their survival, we are looking at better treatments. People who are getting pancreatic cancer later are living longer as a result of better treatments.
But it’s not just that. It’s also, if you’re diagnosed earlier, your 5-year survival rate is higher. More people who are diagnosed early live to five years than those that are diagnosed later. So within that statistic, there are more people who are diagnosed earlier. And those people also live longer. So it takes into account all of those things, which is why we really like to look at that five-year survival rate for a disease like pancreatic cancer.
Dr. Whyte: Where are we on screening? Because we always want to catch people early. That gives them that greatest chance of survival. Have we made much improvements there? And if we have, what are they?
Dr. Matrisian: Well we have made improvements there are more people that are now diagnosed with localized disease than there were 20 years ago. So that is increasing. And we’re still doing it really by being aware of the symptoms right now. Being aware that kind of chronic indigestion, lower back pain that won’t go away, these are signs and symptoms. And especially things like jaundice ...
Dr. Whyte: That yellow color that they might see.
Dr. Matrisian: Yes, that yellow colors in your eye, that’s a really important symptom that would certainly send people to the doctor in order to look at this. So some of it is being more aware and finding the disease earlier. But what we’re really hoping for is some sort of blood test or some sort of other way of looking through medical records and identifying those people that need to go and be checked.
Dr. Whyte: Now we chatted about that almost two years ago. So tell me the progress that we’ve made. How are we doing?
Dr. Matrisian: Yeah, well there’s a number of companies now that have blood tests that are available. They still need more work. They still need more studies to really understand how good they are at finding pancreatic cancer early. But we didn’t have them a couple of years ago. And so it’s really a very exciting time in the field, that there’s companies that were taking advantage of research for many years and actually turning it into a commercial product that is available for people to check.
Dr. Whyte: And then what about treatments? More treatment options today than there were just a few years ago, but still a lot of progress to be made. So when we talk about even 12% 5-year survival, we’d love to see it much more. And you talk about, I don’t want to misquote, so correct me if I’m wrong. Your goal is 20%. Five-year survival by 2030. That’s not too far. So, Lynn, how are we going to get there?
Dr. Matrisian: Okay, well this is our mission. And that’s exactly our goal, 20% by 2030. So we’ve got some work to do. And we are working at both fronts. You’re right, we need better treatments. And so we’ve set up a clinical trial platform where we can look at a lot of different treatments much more efficiently, much faster, kind of taking advantage of an infrastructure to do that. And that’s called Precision Promise. And we’re excited about that as a way to get new treatments for advanced pancreatic cancer.
And then we’re also working on the early detection end. We think an important symptom of pancreatic cancer that isn’t often recognized is new onset diabetes, sudden diabetes in those over 50 where that person did not have diabetes before. So it’s new, looks like type 2 diabetes, but it’s actually caused by pancreatic cancer.
And so we have an initiative, The Early Detection Initiative, that is taking advantage of that. And seeing if we image people right away based on that symptom, can we find pancreatic cancer early? So we think it’s important to look both at trying to diagnose it earlier, as well as trying to treat it better for advanced disease.
Dr. Whyte: Yeah. You know, at WebMD we’re always trying to empower people with better information so they can also become advocates for their health. You’re an expert in advocacy on pancreatic cancer. So what’s your advice to listeners as to how they become good advocates for themselves or advocates in general for loved ones who have pancreatic cancer?
Dr. Matrisian: Yeah. Yeah. Well certainly, knowledge is power. And so the real thing to do is to call the Pancreatic Cancer Action Network. This is what we do. We stay up on the most current information. We have very experienced case managers who can help navigate the complexities of pancreatic cancer at every stage of the journey.
Or if you have questions about pancreatic cancer, call PanCAN. Go to PanCAN.org and give us a call. Because it’s really that knowledge, knowing what it is that you need to get more knowledge about, how to advocate for yourself is very important in a disease, in any disease, but in particular a disease like pancreatic cancer.
Dr. Whyte: And I don’t want to dismiss the progress that we’ve made, that you’ve just referenced in terms of the increased survival. But there’s still a long way to go. We need a lot more dollars for research. We need a lot more clinical trials to take place. What’s your message to a viewer who’s been diagnosed with pancreatic cancer or a loved one? What’s your message, Lynn, today for them?
Dr. Matrisian: Well, first, get as much knowledge as you can. Call PanCAN, and let us help you help your loved one. But then help us. Let’s do research. Let’s do more research. Let’s understand this disease better so we can make those kinds of progress in both treatment and early detection.
And PanCAN works very hard at understanding the disease and setting up research programs that are going to make a difference, that are going to get us to that aggressive goal of 20% survival by 2030. So there is a lot of things that can be done, raise awareness to your friends and neighbors about the disease, lots of things that will help this whole field.
Dr. Whyte: What’s your feeling on second opinions? Given that this can be a difficult cancer to treat, given that there’s emerging therapies that are always developing, when you have a diagnosis of pancreatic cancer, is it important to consider getting a second opinion?
Dr. Matrisian: Yes. Yes, it is. And our case managers will help with that process. We do think it’s important.
Dr. Whyte: Because sometimes, Lynn, people just want to get started, right? Get it out of me. Get treatment. And sometimes getting a second opinion, doing some genomic testing can take time. So what’s your response to that?
Dr. Matrisian: Yeah. Yeah. Well we say, your care team is very important. Who is on your care team, and it may take a little time to find the right people on your care team. But that is an incredibly important step. Sometimes it’s not just one person. Sometimes you need more than one doctor, more than one nurse, more than one type of specialty to help you deal with this. And taking the time to do that is incredibly important.
Yes, you need to – you do need to act. But act smart. And do it with knowledge. Do it really understanding what your options are, and advocate for yourself.
Dr. Whyte: And surround yourself as you reference with that right care team for you, because that’s the most important thing when you have any type of cancer diagnosis. Dr. Lynn Matrisian, I want to thank you for taking time today.
Dr. Matrisian: Thank you so much, John.
A version of this article first appeared on Medscape.com.
Doctors are disappearing from emergency departments as hospitals look to cut costs
She didn’t know much about miscarriage, but this seemed like one.
In the emergency department, she was examined then sent home, she said. She went back when her cramping became excruciating. Then home again. It ultimately took three trips to the ED on 3 consecutive days, generating three separate bills, before she saw a doctor who looked at her blood work and confirmed her fears.
“At the time I wasn’t thinking, ‘Oh, I need to see a doctor,’ ” Ms. Valle recalled. “But when you think about it, it’s like, ‘Well, dang – why didn’t I see a doctor?’ ” It’s unclear whether the repeat visits were due to delays in seeing a physician, but the experience worried her. And she’s still paying the bills.
The hospital declined to discuss Ms. Valle’s care, citing patient privacy. But 17 months before her 3-day ordeal, Tennova had outsourced its emergency departments to American Physician Partners, a medical staffing company owned by private equity investors. APP employs fewer doctors in its EDs as one of its cost-saving initiatives to increase earnings, according to a confidential company document obtained by KHN and NPR.
This staffing strategy has permeated hospitals, and particularly emergency departments, that seek to reduce their top expense: physician labor. While diagnosing and treating patients was once their domain, doctors are increasingly being replaced by nurse practitioners and physician assistants, collectively known as “midlevel practitioners,” who can perform many of the same duties and generate much of the same revenue for less than half of the pay.
“APP has numerous cost saving initiatives underway as part of the Company’s continual focus on cost optimization,” the document says, including a “shift of staffing” between doctors and midlevel practitioners.
In a statement to KHN, American Physician Partners said this strategy is a way to ensure all EDs remain fully staffed, calling it a “blended model” that allows doctors, nurse practitioners, and physician assistants “to provide care to their fullest potential.”
Critics of this strategy say the quest to save money results in treatment meted out by someone with far less training than a physician, leaving patients vulnerable to misdiagnoses, higher medical bills, and inadequate care. And these fears are bolstered by evidence that suggests dropping doctors from EDs may not be good for patients.
A working paper, published in October by the National Bureau of Economic Research, analyzed roughly 1.1 million visits to 44 EDs throughout the Veterans Health Administration, where nurse practitioners can treat patients without oversight from doctors.
Researchers found that treatment by a nurse practitioner resulted on average in a 7% increase in cost of care and an 11% increase in length of stay, extending patients’ time in the ED by minutes for minor visits and hours for longer ones. These gaps widened among patients with more severe diagnoses, the study said, but could be somewhat mitigated by nurse practitioners with more experience.
The study also found that ED patients treated by a nurse practitioner were 20% more likely to be readmitted to the hospital for a preventable reason within 30 days, although the overall risk of readmission remained very small.
Yiqun Chen, PhD, who is an assistant professor of economics at the University of Illinois at Chicago and coauthored the study, said these findings are not an indictment of nurse practitioners in the ED. Instead, she said, she hopes the study will guide how to best deploy nurse practitioners: in treatment of simpler patients or circumstances when no doctor is available.
“It’s not just a simple question of if we can substitute physicians with nurse practitioners or not,” Dr. Chen said. “It depends on how we use them. If we just use them as independent providers, especially ... for relatively complicated patients, it doesn’t seem to be a very good use.”
Dr. Chen’s research echoes smaller studies, like one from The Harvey L. Neiman Health Policy Institute that found nonphysician practitioners in EDs were associated with a 5.3% increase in imaging, which could unnecessarily increase bills for patients. Separately, a study at the Hattiesburg Clinic in Mississippi found that midlevel practitioners in primary care – not in the emergency department – increased the out-of-pocket costs to patients while also leading to worse performance on 9 of 10 quality-of-care metrics, including cancer screenings and vaccination rates.
But definitive evidence remains elusive that replacing ER doctors with nonphysicians has a negative impact on patients, said Cameron Gettel, MD, an assistant professor of emergency medicine at Yale University, New Haven, Conn. Private equity investment and the use of midlevel practitioners rose in lockstep in the ED, Dr. Gettel said, and in the absence of game-changing research, the pattern will likely continue.
“Worse patient outcomes haven’t really been shown across the board,” he said. “And I think until that is shown, then they will continue to play an increasing role.”
For private equity, dropping ED docs is a “simple equation”
Private equity companies pool money from wealthy investors to buy their way into various industries, often slashing spending and seeking to flip businesses in 3 to 7 years. While this business model is a proven moneymaker on Wall Street, it raises concerns in health care, where critics worry the pressure to turn big profits will influence life-or-death decisions that were once left solely to medical professionals.
Nearly $1 trillion in private equity funds have gone into almost 8,000 health care transactions over the past decade, according to industry tracker PitchBook, including buying into medical staffing companies that many hospitals hire to manage their emergency departments.
Two firms dominate the ED staffing industry: TeamHealth, bought by private equity firm Blackstone in 2016, and Envision Healthcare, bought by KKR in 2018. Trying to undercut these staffing giants is American Physician Partners, a rapidly expanding company that runs EDs in at least 17 states and is 50% owned by private equity firm BBH Capital Partners.
These staffing companies have been among the most aggressive in replacing doctors to cut costs, said Robert McNamara, MD, a founder of the American Academy of Emergency Medicine and chair of emergency medicine at Temple University, Philadelphia.
“It’s a relatively simple equation,” Dr. McNamara said. “Their No. 1 expense is the board-certified emergency physician. So they are going to want to keep that expense as low as possible.”
Not everyone sees the trend of private equity in ED staffing in a negative light. Jennifer Orozco, president of the American Academy of Physician Associates, which represents physician assistants, said even if the change – to use more nonphysician providers – is driven by the staffing firms’ desire to make more money, patients are still well served by a team approach that includes nurse practitioners and physician assistants.
“Though I see that shift, it’s not about profits at the end of the day,” Ms. Orozco said. “It’s about the patient.”
The “shift” is nearly invisible to patients because hospitals rarely promote branding from their ED staffing firms and there is little public documentation of private equity investments.
Arthur Smolensky, MD, a Tennessee emergency medicine specialist attempting to measure private equity’s intrusion into EDs, said his review of hospital job postings and employment contracts in 14 major metropolitan areas found that 43% of ED patients were seen in EDs staffed by companies with nonphysician owners, nearly all of whom are private equity investors.
Dr. Smolensky hopes to publish his full study, expanding to 55 metro areas, later this year. But this research will merely quantify what many doctors already know: The ED has changed. Demoralized by an increased focus on profit, and wary of a looming surplus of emergency medicine residents because there are fewer jobs to fill, many experienced doctors are leaving the ED on their own, he said.
“Most of us didn’t go into medicine to supervise an army of people that are not as well trained as we are,” Dr. Smolensky said. “We want to take care of patients.”
“I guess we’re the first guinea pigs for our ER”
Joshua Allen, a nurse practitioner at a small Kentucky hospital, snaked a rubber hose through a rack of pork ribs to practice inserting a chest tube to fix a collapsed lung.
It was 2020, and American Physician Partners was restructuring the ED where Mr. Allen worked, reducing shifts from two doctors to one. Once Mr. Allen had placed 10 tubes under a doctor’s supervision, he would be allowed to do it on his own.
“I guess we’re the first guinea pigs for our ER,” he said. “If we do have a major trauma and multiple victims come in, there’s only one doctor there. ... We need to be prepared.”
Mr. Allen is one of many midlevel practitioners finding work in emergency departments. Nurse practitioners and physician assistants are among the fastest-growing occupations in the nation, according to the U.S. Bureau of Labor Statistics.
Generally, they have master’s degrees and receive several years of specialized schooling but have significantly less training than doctors. Many are permitted to diagnose patients and prescribe medication with little or no supervision from a doctor, although limitations vary by state.
The Neiman Institute found that the share of ED visits in which a midlevel practitioner was the main clinician increased by more than 172% between 2005 and 2020. Another study, in the Journal of Emergency Medicine, reported that if trends continue there may be equal numbers of midlevel practitioners and doctors in EDs by 2030.
There is little mystery as to why. Federal data shows emergency medicine doctors are paid about $310,000 a year on average, while nurse practitioners and physician assistants earn less than $120,000. Generally, hospitals can bill for care by a midlevel practitioner at 85% the rate of a doctor while paying them less than half as much.
Private equity can make millions in the gap.
For example, Envision once encouraged EDs to employ “the least expensive resource” and treat up to 35% of patients with midlevel practitioners, according to a 2017 PowerPoint presentation. The presentation drew scorn on social media and disappeared from Envision’s website.
Envision declined a request for a phone interview. In a written statement to KHN, spokesperson Aliese Polk said the company does not direct its physician leaders on how to care for patients and called the presentation a “concept guide” that does not represent current views.
American Physician Partners touted roughly the same staffing strategy in 2021 in response to the No Surprises Act, which threatened the company’s profits by outlawing surprise medical bills. In its confidential pitch to lenders, the company estimated it could cut almost $6 million by shifting more staffing from physicians to midlevel practitioners.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
She didn’t know much about miscarriage, but this seemed like one.
In the emergency department, she was examined then sent home, she said. She went back when her cramping became excruciating. Then home again. It ultimately took three trips to the ED on 3 consecutive days, generating three separate bills, before she saw a doctor who looked at her blood work and confirmed her fears.
“At the time I wasn’t thinking, ‘Oh, I need to see a doctor,’ ” Ms. Valle recalled. “But when you think about it, it’s like, ‘Well, dang – why didn’t I see a doctor?’ ” It’s unclear whether the repeat visits were due to delays in seeing a physician, but the experience worried her. And she’s still paying the bills.
The hospital declined to discuss Ms. Valle’s care, citing patient privacy. But 17 months before her 3-day ordeal, Tennova had outsourced its emergency departments to American Physician Partners, a medical staffing company owned by private equity investors. APP employs fewer doctors in its EDs as one of its cost-saving initiatives to increase earnings, according to a confidential company document obtained by KHN and NPR.
This staffing strategy has permeated hospitals, and particularly emergency departments, that seek to reduce their top expense: physician labor. While diagnosing and treating patients was once their domain, doctors are increasingly being replaced by nurse practitioners and physician assistants, collectively known as “midlevel practitioners,” who can perform many of the same duties and generate much of the same revenue for less than half of the pay.
“APP has numerous cost saving initiatives underway as part of the Company’s continual focus on cost optimization,” the document says, including a “shift of staffing” between doctors and midlevel practitioners.
In a statement to KHN, American Physician Partners said this strategy is a way to ensure all EDs remain fully staffed, calling it a “blended model” that allows doctors, nurse practitioners, and physician assistants “to provide care to their fullest potential.”
Critics of this strategy say the quest to save money results in treatment meted out by someone with far less training than a physician, leaving patients vulnerable to misdiagnoses, higher medical bills, and inadequate care. And these fears are bolstered by evidence that suggests dropping doctors from EDs may not be good for patients.
A working paper, published in October by the National Bureau of Economic Research, analyzed roughly 1.1 million visits to 44 EDs throughout the Veterans Health Administration, where nurse practitioners can treat patients without oversight from doctors.
Researchers found that treatment by a nurse practitioner resulted on average in a 7% increase in cost of care and an 11% increase in length of stay, extending patients’ time in the ED by minutes for minor visits and hours for longer ones. These gaps widened among patients with more severe diagnoses, the study said, but could be somewhat mitigated by nurse practitioners with more experience.
The study also found that ED patients treated by a nurse practitioner were 20% more likely to be readmitted to the hospital for a preventable reason within 30 days, although the overall risk of readmission remained very small.
Yiqun Chen, PhD, who is an assistant professor of economics at the University of Illinois at Chicago and coauthored the study, said these findings are not an indictment of nurse practitioners in the ED. Instead, she said, she hopes the study will guide how to best deploy nurse practitioners: in treatment of simpler patients or circumstances when no doctor is available.
“It’s not just a simple question of if we can substitute physicians with nurse practitioners or not,” Dr. Chen said. “It depends on how we use them. If we just use them as independent providers, especially ... for relatively complicated patients, it doesn’t seem to be a very good use.”
Dr. Chen’s research echoes smaller studies, like one from The Harvey L. Neiman Health Policy Institute that found nonphysician practitioners in EDs were associated with a 5.3% increase in imaging, which could unnecessarily increase bills for patients. Separately, a study at the Hattiesburg Clinic in Mississippi found that midlevel practitioners in primary care – not in the emergency department – increased the out-of-pocket costs to patients while also leading to worse performance on 9 of 10 quality-of-care metrics, including cancer screenings and vaccination rates.
But definitive evidence remains elusive that replacing ER doctors with nonphysicians has a negative impact on patients, said Cameron Gettel, MD, an assistant professor of emergency medicine at Yale University, New Haven, Conn. Private equity investment and the use of midlevel practitioners rose in lockstep in the ED, Dr. Gettel said, and in the absence of game-changing research, the pattern will likely continue.
“Worse patient outcomes haven’t really been shown across the board,” he said. “And I think until that is shown, then they will continue to play an increasing role.”
For private equity, dropping ED docs is a “simple equation”
Private equity companies pool money from wealthy investors to buy their way into various industries, often slashing spending and seeking to flip businesses in 3 to 7 years. While this business model is a proven moneymaker on Wall Street, it raises concerns in health care, where critics worry the pressure to turn big profits will influence life-or-death decisions that were once left solely to medical professionals.
Nearly $1 trillion in private equity funds have gone into almost 8,000 health care transactions over the past decade, according to industry tracker PitchBook, including buying into medical staffing companies that many hospitals hire to manage their emergency departments.
Two firms dominate the ED staffing industry: TeamHealth, bought by private equity firm Blackstone in 2016, and Envision Healthcare, bought by KKR in 2018. Trying to undercut these staffing giants is American Physician Partners, a rapidly expanding company that runs EDs in at least 17 states and is 50% owned by private equity firm BBH Capital Partners.
These staffing companies have been among the most aggressive in replacing doctors to cut costs, said Robert McNamara, MD, a founder of the American Academy of Emergency Medicine and chair of emergency medicine at Temple University, Philadelphia.
“It’s a relatively simple equation,” Dr. McNamara said. “Their No. 1 expense is the board-certified emergency physician. So they are going to want to keep that expense as low as possible.”
Not everyone sees the trend of private equity in ED staffing in a negative light. Jennifer Orozco, president of the American Academy of Physician Associates, which represents physician assistants, said even if the change – to use more nonphysician providers – is driven by the staffing firms’ desire to make more money, patients are still well served by a team approach that includes nurse practitioners and physician assistants.
“Though I see that shift, it’s not about profits at the end of the day,” Ms. Orozco said. “It’s about the patient.”
The “shift” is nearly invisible to patients because hospitals rarely promote branding from their ED staffing firms and there is little public documentation of private equity investments.
Arthur Smolensky, MD, a Tennessee emergency medicine specialist attempting to measure private equity’s intrusion into EDs, said his review of hospital job postings and employment contracts in 14 major metropolitan areas found that 43% of ED patients were seen in EDs staffed by companies with nonphysician owners, nearly all of whom are private equity investors.
Dr. Smolensky hopes to publish his full study, expanding to 55 metro areas, later this year. But this research will merely quantify what many doctors already know: The ED has changed. Demoralized by an increased focus on profit, and wary of a looming surplus of emergency medicine residents because there are fewer jobs to fill, many experienced doctors are leaving the ED on their own, he said.
“Most of us didn’t go into medicine to supervise an army of people that are not as well trained as we are,” Dr. Smolensky said. “We want to take care of patients.”
“I guess we’re the first guinea pigs for our ER”
Joshua Allen, a nurse practitioner at a small Kentucky hospital, snaked a rubber hose through a rack of pork ribs to practice inserting a chest tube to fix a collapsed lung.
It was 2020, and American Physician Partners was restructuring the ED where Mr. Allen worked, reducing shifts from two doctors to one. Once Mr. Allen had placed 10 tubes under a doctor’s supervision, he would be allowed to do it on his own.
“I guess we’re the first guinea pigs for our ER,” he said. “If we do have a major trauma and multiple victims come in, there’s only one doctor there. ... We need to be prepared.”
Mr. Allen is one of many midlevel practitioners finding work in emergency departments. Nurse practitioners and physician assistants are among the fastest-growing occupations in the nation, according to the U.S. Bureau of Labor Statistics.
Generally, they have master’s degrees and receive several years of specialized schooling but have significantly less training than doctors. Many are permitted to diagnose patients and prescribe medication with little or no supervision from a doctor, although limitations vary by state.
The Neiman Institute found that the share of ED visits in which a midlevel practitioner was the main clinician increased by more than 172% between 2005 and 2020. Another study, in the Journal of Emergency Medicine, reported that if trends continue there may be equal numbers of midlevel practitioners and doctors in EDs by 2030.
There is little mystery as to why. Federal data shows emergency medicine doctors are paid about $310,000 a year on average, while nurse practitioners and physician assistants earn less than $120,000. Generally, hospitals can bill for care by a midlevel practitioner at 85% the rate of a doctor while paying them less than half as much.
Private equity can make millions in the gap.
For example, Envision once encouraged EDs to employ “the least expensive resource” and treat up to 35% of patients with midlevel practitioners, according to a 2017 PowerPoint presentation. The presentation drew scorn on social media and disappeared from Envision’s website.
Envision declined a request for a phone interview. In a written statement to KHN, spokesperson Aliese Polk said the company does not direct its physician leaders on how to care for patients and called the presentation a “concept guide” that does not represent current views.
American Physician Partners touted roughly the same staffing strategy in 2021 in response to the No Surprises Act, which threatened the company’s profits by outlawing surprise medical bills. In its confidential pitch to lenders, the company estimated it could cut almost $6 million by shifting more staffing from physicians to midlevel practitioners.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
She didn’t know much about miscarriage, but this seemed like one.
In the emergency department, she was examined then sent home, she said. She went back when her cramping became excruciating. Then home again. It ultimately took three trips to the ED on 3 consecutive days, generating three separate bills, before she saw a doctor who looked at her blood work and confirmed her fears.
“At the time I wasn’t thinking, ‘Oh, I need to see a doctor,’ ” Ms. Valle recalled. “But when you think about it, it’s like, ‘Well, dang – why didn’t I see a doctor?’ ” It’s unclear whether the repeat visits were due to delays in seeing a physician, but the experience worried her. And she’s still paying the bills.
The hospital declined to discuss Ms. Valle’s care, citing patient privacy. But 17 months before her 3-day ordeal, Tennova had outsourced its emergency departments to American Physician Partners, a medical staffing company owned by private equity investors. APP employs fewer doctors in its EDs as one of its cost-saving initiatives to increase earnings, according to a confidential company document obtained by KHN and NPR.
This staffing strategy has permeated hospitals, and particularly emergency departments, that seek to reduce their top expense: physician labor. While diagnosing and treating patients was once their domain, doctors are increasingly being replaced by nurse practitioners and physician assistants, collectively known as “midlevel practitioners,” who can perform many of the same duties and generate much of the same revenue for less than half of the pay.
“APP has numerous cost saving initiatives underway as part of the Company’s continual focus on cost optimization,” the document says, including a “shift of staffing” between doctors and midlevel practitioners.
In a statement to KHN, American Physician Partners said this strategy is a way to ensure all EDs remain fully staffed, calling it a “blended model” that allows doctors, nurse practitioners, and physician assistants “to provide care to their fullest potential.”
Critics of this strategy say the quest to save money results in treatment meted out by someone with far less training than a physician, leaving patients vulnerable to misdiagnoses, higher medical bills, and inadequate care. And these fears are bolstered by evidence that suggests dropping doctors from EDs may not be good for patients.
A working paper, published in October by the National Bureau of Economic Research, analyzed roughly 1.1 million visits to 44 EDs throughout the Veterans Health Administration, where nurse practitioners can treat patients without oversight from doctors.
Researchers found that treatment by a nurse practitioner resulted on average in a 7% increase in cost of care and an 11% increase in length of stay, extending patients’ time in the ED by minutes for minor visits and hours for longer ones. These gaps widened among patients with more severe diagnoses, the study said, but could be somewhat mitigated by nurse practitioners with more experience.
The study also found that ED patients treated by a nurse practitioner were 20% more likely to be readmitted to the hospital for a preventable reason within 30 days, although the overall risk of readmission remained very small.
Yiqun Chen, PhD, who is an assistant professor of economics at the University of Illinois at Chicago and coauthored the study, said these findings are not an indictment of nurse practitioners in the ED. Instead, she said, she hopes the study will guide how to best deploy nurse practitioners: in treatment of simpler patients or circumstances when no doctor is available.
“It’s not just a simple question of if we can substitute physicians with nurse practitioners or not,” Dr. Chen said. “It depends on how we use them. If we just use them as independent providers, especially ... for relatively complicated patients, it doesn’t seem to be a very good use.”
Dr. Chen’s research echoes smaller studies, like one from The Harvey L. Neiman Health Policy Institute that found nonphysician practitioners in EDs were associated with a 5.3% increase in imaging, which could unnecessarily increase bills for patients. Separately, a study at the Hattiesburg Clinic in Mississippi found that midlevel practitioners in primary care – not in the emergency department – increased the out-of-pocket costs to patients while also leading to worse performance on 9 of 10 quality-of-care metrics, including cancer screenings and vaccination rates.
But definitive evidence remains elusive that replacing ER doctors with nonphysicians has a negative impact on patients, said Cameron Gettel, MD, an assistant professor of emergency medicine at Yale University, New Haven, Conn. Private equity investment and the use of midlevel practitioners rose in lockstep in the ED, Dr. Gettel said, and in the absence of game-changing research, the pattern will likely continue.
“Worse patient outcomes haven’t really been shown across the board,” he said. “And I think until that is shown, then they will continue to play an increasing role.”
For private equity, dropping ED docs is a “simple equation”
Private equity companies pool money from wealthy investors to buy their way into various industries, often slashing spending and seeking to flip businesses in 3 to 7 years. While this business model is a proven moneymaker on Wall Street, it raises concerns in health care, where critics worry the pressure to turn big profits will influence life-or-death decisions that were once left solely to medical professionals.
Nearly $1 trillion in private equity funds have gone into almost 8,000 health care transactions over the past decade, according to industry tracker PitchBook, including buying into medical staffing companies that many hospitals hire to manage their emergency departments.
Two firms dominate the ED staffing industry: TeamHealth, bought by private equity firm Blackstone in 2016, and Envision Healthcare, bought by KKR in 2018. Trying to undercut these staffing giants is American Physician Partners, a rapidly expanding company that runs EDs in at least 17 states and is 50% owned by private equity firm BBH Capital Partners.
These staffing companies have been among the most aggressive in replacing doctors to cut costs, said Robert McNamara, MD, a founder of the American Academy of Emergency Medicine and chair of emergency medicine at Temple University, Philadelphia.
“It’s a relatively simple equation,” Dr. McNamara said. “Their No. 1 expense is the board-certified emergency physician. So they are going to want to keep that expense as low as possible.”
Not everyone sees the trend of private equity in ED staffing in a negative light. Jennifer Orozco, president of the American Academy of Physician Associates, which represents physician assistants, said even if the change – to use more nonphysician providers – is driven by the staffing firms’ desire to make more money, patients are still well served by a team approach that includes nurse practitioners and physician assistants.
“Though I see that shift, it’s not about profits at the end of the day,” Ms. Orozco said. “It’s about the patient.”
The “shift” is nearly invisible to patients because hospitals rarely promote branding from their ED staffing firms and there is little public documentation of private equity investments.
Arthur Smolensky, MD, a Tennessee emergency medicine specialist attempting to measure private equity’s intrusion into EDs, said his review of hospital job postings and employment contracts in 14 major metropolitan areas found that 43% of ED patients were seen in EDs staffed by companies with nonphysician owners, nearly all of whom are private equity investors.
Dr. Smolensky hopes to publish his full study, expanding to 55 metro areas, later this year. But this research will merely quantify what many doctors already know: The ED has changed. Demoralized by an increased focus on profit, and wary of a looming surplus of emergency medicine residents because there are fewer jobs to fill, many experienced doctors are leaving the ED on their own, he said.
“Most of us didn’t go into medicine to supervise an army of people that are not as well trained as we are,” Dr. Smolensky said. “We want to take care of patients.”
“I guess we’re the first guinea pigs for our ER”
Joshua Allen, a nurse practitioner at a small Kentucky hospital, snaked a rubber hose through a rack of pork ribs to practice inserting a chest tube to fix a collapsed lung.
It was 2020, and American Physician Partners was restructuring the ED where Mr. Allen worked, reducing shifts from two doctors to one. Once Mr. Allen had placed 10 tubes under a doctor’s supervision, he would be allowed to do it on his own.
“I guess we’re the first guinea pigs for our ER,” he said. “If we do have a major trauma and multiple victims come in, there’s only one doctor there. ... We need to be prepared.”
Mr. Allen is one of many midlevel practitioners finding work in emergency departments. Nurse practitioners and physician assistants are among the fastest-growing occupations in the nation, according to the U.S. Bureau of Labor Statistics.
Generally, they have master’s degrees and receive several years of specialized schooling but have significantly less training than doctors. Many are permitted to diagnose patients and prescribe medication with little or no supervision from a doctor, although limitations vary by state.
The Neiman Institute found that the share of ED visits in which a midlevel practitioner was the main clinician increased by more than 172% between 2005 and 2020. Another study, in the Journal of Emergency Medicine, reported that if trends continue there may be equal numbers of midlevel practitioners and doctors in EDs by 2030.
There is little mystery as to why. Federal data shows emergency medicine doctors are paid about $310,000 a year on average, while nurse practitioners and physician assistants earn less than $120,000. Generally, hospitals can bill for care by a midlevel practitioner at 85% the rate of a doctor while paying them less than half as much.
Private equity can make millions in the gap.
For example, Envision once encouraged EDs to employ “the least expensive resource” and treat up to 35% of patients with midlevel practitioners, according to a 2017 PowerPoint presentation. The presentation drew scorn on social media and disappeared from Envision’s website.
Envision declined a request for a phone interview. In a written statement to KHN, spokesperson Aliese Polk said the company does not direct its physician leaders on how to care for patients and called the presentation a “concept guide” that does not represent current views.
American Physician Partners touted roughly the same staffing strategy in 2021 in response to the No Surprises Act, which threatened the company’s profits by outlawing surprise medical bills. In its confidential pitch to lenders, the company estimated it could cut almost $6 million by shifting more staffing from physicians to midlevel practitioners.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
New report says suicide rates rising among young Black people
Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.
In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.
Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.
“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.
The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.
CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic.
From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.
“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.
A version of this article first appeared on WebMD.com.
Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.
In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.
Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.
“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.
The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.
CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic.
From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.
“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.
A version of this article first appeared on WebMD.com.
Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.
In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.
Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.
“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.
The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.
CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic.
From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.
“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.
A version of this article first appeared on WebMD.com.
Antenatal corticosteroids: Fresh answers to old questions
Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.
Neurodevelopmental outcomes in late preterm
First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?
A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.
Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.
Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.
At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.
Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.
“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
Are boosters better?
The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.
Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.
ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.
The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.
A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.
“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”
The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.
Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.
Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.
The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.
“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”
But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”
The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.
Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.
A version of this article originally appeared on Medscape.com.
Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.
Neurodevelopmental outcomes in late preterm
First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?
A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.
Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.
Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.
At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.
Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.
“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
Are boosters better?
The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.
Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.
ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.
The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.
A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.
“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”
The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.
Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.
Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.
The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.
“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”
But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”
The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.
Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.
A version of this article originally appeared on Medscape.com.
Giving corticosteroids to pregnant women at risk for preterm birth before 34 weeks of gestational age has been the standard of care since the 1990s, but a few scenarios for their use remain up for debate. Two studies presented this week at the 2023 meeting sponsored by the Society for Maternal–Fetal Medicine provided some fresh insight into the practice that could help clinicians better manage pregnant patients.
Neurodevelopmental outcomes in late preterm
First, should antenatal corticosteroids (ACS) be given to mothers who present with late preterm labor, defined as 34-36 weeks’ gestational age?
A landmark randomized clinical trial published in 2016 demonstrated that use of ACS in mothers in late preterm labor reduced severe respiratory complications. That practice has largely been adopted by clinicians. The only downside, according to the researchers, was that infants whose mothers received steroid therapy were more likely to develop hypoglycemia. The condition is self-limiting, but studies have raised concern about the potential long-term risk of neurocognitive or psychological outcomes in infants with hypoglycemia.
Cynthia Gyamfi-Bannerman, MD, MSc, endowed chair and professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Diego, led the 2016 study. Her team was unable to secure funding for their originally planned follow-up study of the infants 2 years later. But once the American College of Obstetricians and Gynecologists endorsed the practice and more women received ACS in the late preterm period, Dr. Gyamfi-Bannerman and her colleagues felt the need to “follow up the infants just to see what the outcomes are from a neurodevelopmental standpoint,” she said.
Dr. Gyamfi-Bannerman and colleagues recruited children older than age 6 from the original trial whose parents were willing to have them participate in a follow-up study. A total of 949 from the initial 2,831 cohort completed cognitive testing and received assessments for cerebral palsy, social impairment within the autism spectrum, and behavioral and emotional problems.
At the SMFM conference, Dr. Gyamfi-Bannerman reported no differences in the primary outcome of cognitive function between those whose mothers had received a single course of betamethasone and those who did not, or any differences in rates of the other outcomes.
Kathy Zhang-Rutledge, MD, a maternal-fetal medicine specialist who practices with Obstetrix Maternal Fetal Medicine Group of Houston, part of Pediatrix Medical Group, said she was glad to see a study that addressed the potential long-term adverse events associated with ACS in the late preterm period.
“Having this pretty large study – with really good neurological testing results – should help reassure clinicians that this is something they should consider adopting in their practice,” Dr. Zhang-Rutledge said.
Are boosters better?
The second unresolved question was if a repeat course of ACS should be administered when a woman at risk for preterm birth receives a course of steroids but does not deliver in the following 7 days.
Any benefits to the initial course of ACS wear off after a week. As a result, clinicians often give booster courses 7 days after the first dose if the infant is likely to be delivered in the following week. A 2009 study showed this approach may protect infants from respiratory problems, but data on long-term outcomes have been weak.
ACOG guidelines say to “consider” a booster dose in women who are less than 34 weeks’ gestation at risk for preterm delivery within 7 days.
The exception is when the mother already has experienced preterm prelabor rupture of membranes (PPROM), because ACS may increase the risk for infection for both mother and child. ACOG doesn’t take a stand on use of booster doses for PPROM, citing a lack of data to show that potential benefits outweigh the potential risks of this approach.
A recent multicenter, double-blinded, randomized clinical trial attempted to fill that void in knowledge. Between 2016 and 2022, 194 women with PPROM and gestational age less than 32 weeks who had received an initial ACS course at least 7 days prior to randomization received a booster course of ACS or saline placebo.
“Our primary outcome was designed to be like the prior rescue study (in 2009) that we did with patients with intact membranes,” said Andrew Combs, MD, PhD, a maternal-fetal medicine specialist at Pediatrix Medical Group in Sunrise, Fla., who participated in the earlier study. “It was a composite of neonatal morbidity that was any one of a variety of outcomes including respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, and neonatal death.”
The primary outcome occurred in 64% of women who received booster ACS and 66% with placebo (odds ratio, 0.82; 95% confidence interval, 0.43-1.57), according to Dr. Combs, who presented the findings at SMFM.
Although the study was not powered to detect significant differences in specific outcomes, the rate of neonatal sepsis was not higher in the ACS group, suggesting that ACS may be safe if membranes have ruptured, the researchers reported. But because the booster course of ACS did not prevent respiratory morbidity, clinicians may wonder what to do with the findings.
Niraj Chavan, MD, an associate professor in the department of obstetrics, gynecology, and women’s health at Saint Louis University, said he was unsure how the study would affect clinical practice.
The relatively small sample number of patients prevented analysis of specific outcomes and subgroup analyses of important variables such as race, ethnicity, gestational age, and other comorbid conditions in the mothers, he said. So clinicians still must weigh potential risks and benefits on a case-by-case basis.
“You have to think about it in buckets,” he said, “One is conditions that would increase the risk for neonatal morbidity. The other is the risk for infection, both for the mom and the baby.”
But for Dr. Combs, the interpretation of the findings was simpler: “We concluded that there’s no indication to give a booster course of steroids after a week has elapsed in patients with ruptured membranes.”
The study presented by Dr. Gyamfi-Bannerman was funded by the National Institute of Child Health and Human Development. The study presented by Dr. Combs was funded by MEDNAX Center for Research, Education, and Quality, which in 2022 was renamed Pediatrix Center for Research, Education,and Quality. Dr. Combs is an employee of Pediatrix Medical Group but has no conflicts of interest. Dr. Gyamfi-Bannerman, Dr. Zhang-Rutledge, and Dr. Chavan report no relevant financial relationships.
Ann Thomas is a pediatrician and epidemiologist in Portland, Ore.
A version of this article originally appeared on Medscape.com.
FROM THE PREGNANCY MEETING
Isothiazolinone contact allergy up in North America, down in Europe
, a trend that is likely driven by regulatory differences, a retrospective cohort study suggests.
“Between 2009 to 2018, the global burden of isothiazolinone allergy showed divergent trends between North American and European countries,” lead study author Margo J. Reeder, MD, of the University of Wisconsin in Madison and her colleagues write. The study was published online in JAMA Dermatology.
Isothiazolinone contact allergy peaked in Europe in 2013-2014 before gradually decreasing, they found. The prevalence of isothiazolinone allergy steadily increased in North America during the study period. “Earlier and more stringent regulation of MI [methylisothiazolinone] in Europe is associated with these divergent trends,” they write.
Common ingredients worldwide
Isothiazolinone preservatives, which are added to personal and industrial products, cause allergic contact dermatitis worldwide, the authors write. The preservatives are found in a wide range of leave-on and rinse-off water-based personal care products, such as shampoo and other hair products, dishwashing liquid, face cream, body lotion, shower gel, liquid soap, and wet wipes, as well as in water-based paint.
A mixture of methylchloroisothiazolinone (MCI) and MI has been used to prevent microbial growth in products since the 1980s. In 2005, U.S. and European regulators approved MI alone at higher concentrations as a preservative in personal care products. Coupled with consumer concerns about other preservatives, such as parabens (a rare allergen), use of MI in personal care products increased, the authors write.
Subsequently, researchers reported a global increase in the prevalence of contact allergy to isothiazolinones, the authors write. Regulatory restrictions on MI in personal care products were implemented in 2013 in Europe and in 2015 in Canada but not in the United States.
Patch test data reveal latest trends
To compare prevalence trends of allergic contact allergy to MI and sensitization to the MCI/MI mixture in North America and in Europe, Dr. Reeder and her colleagues compared the prevalence of positive patch test reactions to MCI/MI and to MI alone in North America and in Europe between 2009 and 2018.
They analyzed data from the North American Contact Dermatitis Group (NACDG), the European Surveillance System on Contact Allergies (ESSCA), and the Information Network of Departments of Dermatology (IVDK) in 2-year intervals. The data came from patients who had been patch tested at referral patch test clinics in North America and Europe.
Over the decade, the study sites conducted patch testing for 226,161 patients for MCI/MI and 118,779 for MI. Most data came from Europe. The researchers found the following:
- In Europe, isothiazolinone allergy peaked in 2013 and 2014; MCI/MI positivity reached 7.6% (ESSCA) and 5.4% (IVDK) before decreasing to 4.4% (ESSCA) and 3.2% (IVDK) in 2017-2018.
- In North America, MCI/MI positivity rose steadily from 2.5% in 2009-2010 to 10.8% in 2017-2018.
- In Europe, there were 5.5% (ESSCA) and 3.4% (IVDK) positive reactions to MI, compared with 15% (NACDG) in North America in 2017-2018.
Divergent contact allergy trends linked to regulatory approaches
The downward trend of isothiazolinone allergy in Europe after its peak in 2013 and 2014 may have been due in part, the authors explain, to a memo released in 2013 by Cosmetics Europe after it and the European Society of Contact Dermatitis reviewed reports of increased contact allergy to MI. The memo urged companies to remove MI from leave-on products.
Later that year, the European Union’s Scientific Committee on Consumer Safety advised omitting MI from leave-on consumer personal care products and moved to restrict the ingredient in rinse-off products to less than 15 ppm. The recommendation took effect in 2015.
That year, Canada banned the use of MCI/MI in leave-on products but allowed MI alone in leave-on products until 2018. The total concentration of MI and MCI in wash-off products was limited to less than 15 ppm.
The authors add that, to their knowledge, the U.S. government does not restrict the use of MCI/MI or MI.
Policy implications for contact allergy
MI is still widely used in “countless products,” including shampoos, skin cleansers, dishwashing and laundry detergents, paints, and adhesives, Daniel W. Shaw, MD, associate professor of dermatology at the University of California, San Diego, told this news organization by email.
“Exact figures between the U.S. and Europe are difficult to compare due to differing patch test concentrations, but the overall trends strongly suggest that stricter and earlier regulation in Europe resulted in lower MI allergy prevalence there than in the U.S.,” added Dr. Shaw, who was not involved in the study.
Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University in Winston-Salem, N.C., said by email that accurate information on allergic reaction prevalence is difficult to find.
“The NACDG, ESSCA, and IVDK databases may contain the best data available, but the data depend on people who get patch tested and are not directly informative of the allergy rates in the general population,” added Dr. Feldman, who was not involved in the study.
“The great majority of people in the population may not be allergic,” he said. “For those with itchy rashes, getting patch tested or avoiding products with preservatives may be prudent. Broad regulations, however, should consider the overall risks and benefits in the population, and this particular study does not fully capture those issues.”
“This study shows that government regulations are important to limit consumer exposure to common allergens, especially to the concentrations used in personal care products,” Kelly Tyler, MD, associate professor of dermatology at the Ohio State University Wexner Medical Center in Columbus, noted by email. She was not involved in the study.
She advised clinicians to ask their patients who may have allergic contact dermatitis whether they have been exposed to products containing these compounds.
“All personal care products in the store contain preservatives, and their maximum concentrations should be limited,” she advised. “The Expert Panel for Cosmetic Ingredient Safety should establish stricter guidelines for MI use in personal care products, especially given the findings of this study.”
Has MI contact allergy in North America peaked?
“In the U.S., MI has not been banned from leave-on skin-care products, but recently, its use has markedly decreased,” Dr. Shaw commented. “Hopefully, the prevalence of MI contact allergy will also begin to decrease.”
New evidence is promising. In a related study published online in Dermatology, Joel G. DeKoven, MD, MHSc, FRCPC, of the University of Toronto and his colleagues reported the NACDG 2019-2020 patch test results for MI in North America. They found that 13.8% of patients tested positive for MI.
“For the first time, MI positivity did not increase between reporting periods,” they conclude. “The epidemic of MI contact allergy in North America may have reached a plateau.”
Information regarding funding for the study was not provided. Dr. Reeder has financial relationships with the American Contact Dermatitis Society and a publishing company. Several coauthors have financial relationships with the pharmaceutical industry. Dr. Tyler, Dr. Shaw, and Dr. Feldman report no relevant financial relationship.
A version of this article first appeared on Medscape.com.
, a trend that is likely driven by regulatory differences, a retrospective cohort study suggests.
“Between 2009 to 2018, the global burden of isothiazolinone allergy showed divergent trends between North American and European countries,” lead study author Margo J. Reeder, MD, of the University of Wisconsin in Madison and her colleagues write. The study was published online in JAMA Dermatology.
Isothiazolinone contact allergy peaked in Europe in 2013-2014 before gradually decreasing, they found. The prevalence of isothiazolinone allergy steadily increased in North America during the study period. “Earlier and more stringent regulation of MI [methylisothiazolinone] in Europe is associated with these divergent trends,” they write.
Common ingredients worldwide
Isothiazolinone preservatives, which are added to personal and industrial products, cause allergic contact dermatitis worldwide, the authors write. The preservatives are found in a wide range of leave-on and rinse-off water-based personal care products, such as shampoo and other hair products, dishwashing liquid, face cream, body lotion, shower gel, liquid soap, and wet wipes, as well as in water-based paint.
A mixture of methylchloroisothiazolinone (MCI) and MI has been used to prevent microbial growth in products since the 1980s. In 2005, U.S. and European regulators approved MI alone at higher concentrations as a preservative in personal care products. Coupled with consumer concerns about other preservatives, such as parabens (a rare allergen), use of MI in personal care products increased, the authors write.
Subsequently, researchers reported a global increase in the prevalence of contact allergy to isothiazolinones, the authors write. Regulatory restrictions on MI in personal care products were implemented in 2013 in Europe and in 2015 in Canada but not in the United States.
Patch test data reveal latest trends
To compare prevalence trends of allergic contact allergy to MI and sensitization to the MCI/MI mixture in North America and in Europe, Dr. Reeder and her colleagues compared the prevalence of positive patch test reactions to MCI/MI and to MI alone in North America and in Europe between 2009 and 2018.
They analyzed data from the North American Contact Dermatitis Group (NACDG), the European Surveillance System on Contact Allergies (ESSCA), and the Information Network of Departments of Dermatology (IVDK) in 2-year intervals. The data came from patients who had been patch tested at referral patch test clinics in North America and Europe.
Over the decade, the study sites conducted patch testing for 226,161 patients for MCI/MI and 118,779 for MI. Most data came from Europe. The researchers found the following:
- In Europe, isothiazolinone allergy peaked in 2013 and 2014; MCI/MI positivity reached 7.6% (ESSCA) and 5.4% (IVDK) before decreasing to 4.4% (ESSCA) and 3.2% (IVDK) in 2017-2018.
- In North America, MCI/MI positivity rose steadily from 2.5% in 2009-2010 to 10.8% in 2017-2018.
- In Europe, there were 5.5% (ESSCA) and 3.4% (IVDK) positive reactions to MI, compared with 15% (NACDG) in North America in 2017-2018.
Divergent contact allergy trends linked to regulatory approaches
The downward trend of isothiazolinone allergy in Europe after its peak in 2013 and 2014 may have been due in part, the authors explain, to a memo released in 2013 by Cosmetics Europe after it and the European Society of Contact Dermatitis reviewed reports of increased contact allergy to MI. The memo urged companies to remove MI from leave-on products.
Later that year, the European Union’s Scientific Committee on Consumer Safety advised omitting MI from leave-on consumer personal care products and moved to restrict the ingredient in rinse-off products to less than 15 ppm. The recommendation took effect in 2015.
That year, Canada banned the use of MCI/MI in leave-on products but allowed MI alone in leave-on products until 2018. The total concentration of MI and MCI in wash-off products was limited to less than 15 ppm.
The authors add that, to their knowledge, the U.S. government does not restrict the use of MCI/MI or MI.
Policy implications for contact allergy
MI is still widely used in “countless products,” including shampoos, skin cleansers, dishwashing and laundry detergents, paints, and adhesives, Daniel W. Shaw, MD, associate professor of dermatology at the University of California, San Diego, told this news organization by email.
“Exact figures between the U.S. and Europe are difficult to compare due to differing patch test concentrations, but the overall trends strongly suggest that stricter and earlier regulation in Europe resulted in lower MI allergy prevalence there than in the U.S.,” added Dr. Shaw, who was not involved in the study.
Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University in Winston-Salem, N.C., said by email that accurate information on allergic reaction prevalence is difficult to find.
“The NACDG, ESSCA, and IVDK databases may contain the best data available, but the data depend on people who get patch tested and are not directly informative of the allergy rates in the general population,” added Dr. Feldman, who was not involved in the study.
“The great majority of people in the population may not be allergic,” he said. “For those with itchy rashes, getting patch tested or avoiding products with preservatives may be prudent. Broad regulations, however, should consider the overall risks and benefits in the population, and this particular study does not fully capture those issues.”
“This study shows that government regulations are important to limit consumer exposure to common allergens, especially to the concentrations used in personal care products,” Kelly Tyler, MD, associate professor of dermatology at the Ohio State University Wexner Medical Center in Columbus, noted by email. She was not involved in the study.
She advised clinicians to ask their patients who may have allergic contact dermatitis whether they have been exposed to products containing these compounds.
“All personal care products in the store contain preservatives, and their maximum concentrations should be limited,” she advised. “The Expert Panel for Cosmetic Ingredient Safety should establish stricter guidelines for MI use in personal care products, especially given the findings of this study.”
Has MI contact allergy in North America peaked?
“In the U.S., MI has not been banned from leave-on skin-care products, but recently, its use has markedly decreased,” Dr. Shaw commented. “Hopefully, the prevalence of MI contact allergy will also begin to decrease.”
New evidence is promising. In a related study published online in Dermatology, Joel G. DeKoven, MD, MHSc, FRCPC, of the University of Toronto and his colleagues reported the NACDG 2019-2020 patch test results for MI in North America. They found that 13.8% of patients tested positive for MI.
“For the first time, MI positivity did not increase between reporting periods,” they conclude. “The epidemic of MI contact allergy in North America may have reached a plateau.”
Information regarding funding for the study was not provided. Dr. Reeder has financial relationships with the American Contact Dermatitis Society and a publishing company. Several coauthors have financial relationships with the pharmaceutical industry. Dr. Tyler, Dr. Shaw, and Dr. Feldman report no relevant financial relationship.
A version of this article first appeared on Medscape.com.
, a trend that is likely driven by regulatory differences, a retrospective cohort study suggests.
“Between 2009 to 2018, the global burden of isothiazolinone allergy showed divergent trends between North American and European countries,” lead study author Margo J. Reeder, MD, of the University of Wisconsin in Madison and her colleagues write. The study was published online in JAMA Dermatology.
Isothiazolinone contact allergy peaked in Europe in 2013-2014 before gradually decreasing, they found. The prevalence of isothiazolinone allergy steadily increased in North America during the study period. “Earlier and more stringent regulation of MI [methylisothiazolinone] in Europe is associated with these divergent trends,” they write.
Common ingredients worldwide
Isothiazolinone preservatives, which are added to personal and industrial products, cause allergic contact dermatitis worldwide, the authors write. The preservatives are found in a wide range of leave-on and rinse-off water-based personal care products, such as shampoo and other hair products, dishwashing liquid, face cream, body lotion, shower gel, liquid soap, and wet wipes, as well as in water-based paint.
A mixture of methylchloroisothiazolinone (MCI) and MI has been used to prevent microbial growth in products since the 1980s. In 2005, U.S. and European regulators approved MI alone at higher concentrations as a preservative in personal care products. Coupled with consumer concerns about other preservatives, such as parabens (a rare allergen), use of MI in personal care products increased, the authors write.
Subsequently, researchers reported a global increase in the prevalence of contact allergy to isothiazolinones, the authors write. Regulatory restrictions on MI in personal care products were implemented in 2013 in Europe and in 2015 in Canada but not in the United States.
Patch test data reveal latest trends
To compare prevalence trends of allergic contact allergy to MI and sensitization to the MCI/MI mixture in North America and in Europe, Dr. Reeder and her colleagues compared the prevalence of positive patch test reactions to MCI/MI and to MI alone in North America and in Europe between 2009 and 2018.
They analyzed data from the North American Contact Dermatitis Group (NACDG), the European Surveillance System on Contact Allergies (ESSCA), and the Information Network of Departments of Dermatology (IVDK) in 2-year intervals. The data came from patients who had been patch tested at referral patch test clinics in North America and Europe.
Over the decade, the study sites conducted patch testing for 226,161 patients for MCI/MI and 118,779 for MI. Most data came from Europe. The researchers found the following:
- In Europe, isothiazolinone allergy peaked in 2013 and 2014; MCI/MI positivity reached 7.6% (ESSCA) and 5.4% (IVDK) before decreasing to 4.4% (ESSCA) and 3.2% (IVDK) in 2017-2018.
- In North America, MCI/MI positivity rose steadily from 2.5% in 2009-2010 to 10.8% in 2017-2018.
- In Europe, there were 5.5% (ESSCA) and 3.4% (IVDK) positive reactions to MI, compared with 15% (NACDG) in North America in 2017-2018.
Divergent contact allergy trends linked to regulatory approaches
The downward trend of isothiazolinone allergy in Europe after its peak in 2013 and 2014 may have been due in part, the authors explain, to a memo released in 2013 by Cosmetics Europe after it and the European Society of Contact Dermatitis reviewed reports of increased contact allergy to MI. The memo urged companies to remove MI from leave-on products.
Later that year, the European Union’s Scientific Committee on Consumer Safety advised omitting MI from leave-on consumer personal care products and moved to restrict the ingredient in rinse-off products to less than 15 ppm. The recommendation took effect in 2015.
That year, Canada banned the use of MCI/MI in leave-on products but allowed MI alone in leave-on products until 2018. The total concentration of MI and MCI in wash-off products was limited to less than 15 ppm.
The authors add that, to their knowledge, the U.S. government does not restrict the use of MCI/MI or MI.
Policy implications for contact allergy
MI is still widely used in “countless products,” including shampoos, skin cleansers, dishwashing and laundry detergents, paints, and adhesives, Daniel W. Shaw, MD, associate professor of dermatology at the University of California, San Diego, told this news organization by email.
“Exact figures between the U.S. and Europe are difficult to compare due to differing patch test concentrations, but the overall trends strongly suggest that stricter and earlier regulation in Europe resulted in lower MI allergy prevalence there than in the U.S.,” added Dr. Shaw, who was not involved in the study.
Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest University in Winston-Salem, N.C., said by email that accurate information on allergic reaction prevalence is difficult to find.
“The NACDG, ESSCA, and IVDK databases may contain the best data available, but the data depend on people who get patch tested and are not directly informative of the allergy rates in the general population,” added Dr. Feldman, who was not involved in the study.
“The great majority of people in the population may not be allergic,” he said. “For those with itchy rashes, getting patch tested or avoiding products with preservatives may be prudent. Broad regulations, however, should consider the overall risks and benefits in the population, and this particular study does not fully capture those issues.”
“This study shows that government regulations are important to limit consumer exposure to common allergens, especially to the concentrations used in personal care products,” Kelly Tyler, MD, associate professor of dermatology at the Ohio State University Wexner Medical Center in Columbus, noted by email. She was not involved in the study.
She advised clinicians to ask their patients who may have allergic contact dermatitis whether they have been exposed to products containing these compounds.
“All personal care products in the store contain preservatives, and their maximum concentrations should be limited,” she advised. “The Expert Panel for Cosmetic Ingredient Safety should establish stricter guidelines for MI use in personal care products, especially given the findings of this study.”
Has MI contact allergy in North America peaked?
“In the U.S., MI has not been banned from leave-on skin-care products, but recently, its use has markedly decreased,” Dr. Shaw commented. “Hopefully, the prevalence of MI contact allergy will also begin to decrease.”
New evidence is promising. In a related study published online in Dermatology, Joel G. DeKoven, MD, MHSc, FRCPC, of the University of Toronto and his colleagues reported the NACDG 2019-2020 patch test results for MI in North America. They found that 13.8% of patients tested positive for MI.
“For the first time, MI positivity did not increase between reporting periods,” they conclude. “The epidemic of MI contact allergy in North America may have reached a plateau.”
Information regarding funding for the study was not provided. Dr. Reeder has financial relationships with the American Contact Dermatitis Society and a publishing company. Several coauthors have financial relationships with the pharmaceutical industry. Dr. Tyler, Dr. Shaw, and Dr. Feldman report no relevant financial relationship.
A version of this article first appeared on Medscape.com.
An 11-year-old boy presents with small itchy bumps on the wrists, face, arms, and legs
The patient was diagnosed with lichen nitidus, given the characteristic clinical presentation.
Lichen nitidus is a rare chronic inflammatory condition of the skin that most commonly presents in children and young adults and does not seem to be restricted to any sex or race. The classic lesions are described as asymptomatic to slightly pruritic, small (1 mm), skin-colored to hypopigmented flat-topped papules.
Koebner phenomenon is usually seen in which the skin lesions appear in areas of traumatized healthy skin. The extremities, abdomen, chest, and penis are common locations for the lesions to occur. Rarely, the oral mucosa or nails can be involved. It has been described in patients with a diagnosis of Crohn’s disease, Niemann-Pick disease, Down syndrome, and HIV. The rare, generalized purpuric variant has been reported in a few cases associated with interferon and ribavirin treatment for hepatitis C infection and nivolumab treatment for cancer. The pathophysiology of lichen nitidus is unknown.
Lichen nitidus can occur in the presence of other skin conditions like lichen planus, atopic dermatitis, vitiligo, erythema nodosum, and lichen spinulosus. Histopathologic characteristics of lichen nitidus are described as a “ball and claw” of epidermal rete around a lymphohistiocytic infiltrate. Parakeratosis overlying epidermal atrophy and focal basal liquefaction degeneration is also seen.
The differential diagnosis of lichen nitidus includes flat warts, which can present as clusters of small flat-topped papules that can show a pseudo-Koebner phenomenon (where the virus is seeded in traumatized skin). The morphological difference between the condition is that lichen nitidus lesions are usually monomorphic, compared with flat warts, which usually present with different sizes and shapes.
Patients with a history of allergic contact dermatitis may present with a generalized monomorphic eruption of skin-colored papules (known as ID reaction) that can sometimes be very similar to lichen nitidus. Allergic contact dermatitis tends to respond fairly quickly to topical or systemic corticosteroids, unlike lichen nitidus. There are a few reports that consider lichen nitidus to be a variant of lichen planus, although they have different histopathologic findings. Lichen planus lesions are described as polygonal, pruritic, purple to pink papules most commonly seen on the wrists, lower back, and ankles. Lichen planus can be seen in patients with hepatitis C and may also occur secondary to medication.
Milia are small keratin cysts on the skin that are commonly seen in babies as primary milia and can be seen in older children secondary to trauma (commonly on the eyelids) or medications. Given their size and monomorphic appearance, they can sometimes be confused with lichen nitidus.
Lichen nitidus is often asymptomatic and the lesions resolve within a few months to years. Topical corticosteroids can be helpful to alleviate the symptoms in patients who present with pruritus. In more persistent and generalized cases, phototherapy, systemic corticosteroids, acitretin, isotretinoin, or cyclosporine can be considered.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.
References
Chu J and Lam JM. CMAJ. 2014 Dec 9;186(18):E688.
Lestringant G et al. Dermatology 1996;192:171-3.
Peterson JA et al. Proc (Bayl Univ Med Cent). 2021 Aug 25;35(1):70-2.
Schwartz C and Goodman MB. “Lichen nitidus,” in StatPearls. Treasure Island, Fla.: StatPearls Publishing, 2022.
The patient was diagnosed with lichen nitidus, given the characteristic clinical presentation.
Lichen nitidus is a rare chronic inflammatory condition of the skin that most commonly presents in children and young adults and does not seem to be restricted to any sex or race. The classic lesions are described as asymptomatic to slightly pruritic, small (1 mm), skin-colored to hypopigmented flat-topped papules.
Koebner phenomenon is usually seen in which the skin lesions appear in areas of traumatized healthy skin. The extremities, abdomen, chest, and penis are common locations for the lesions to occur. Rarely, the oral mucosa or nails can be involved. It has been described in patients with a diagnosis of Crohn’s disease, Niemann-Pick disease, Down syndrome, and HIV. The rare, generalized purpuric variant has been reported in a few cases associated with interferon and ribavirin treatment for hepatitis C infection and nivolumab treatment for cancer. The pathophysiology of lichen nitidus is unknown.
Lichen nitidus can occur in the presence of other skin conditions like lichen planus, atopic dermatitis, vitiligo, erythema nodosum, and lichen spinulosus. Histopathologic characteristics of lichen nitidus are described as a “ball and claw” of epidermal rete around a lymphohistiocytic infiltrate. Parakeratosis overlying epidermal atrophy and focal basal liquefaction degeneration is also seen.
The differential diagnosis of lichen nitidus includes flat warts, which can present as clusters of small flat-topped papules that can show a pseudo-Koebner phenomenon (where the virus is seeded in traumatized skin). The morphological difference between the condition is that lichen nitidus lesions are usually monomorphic, compared with flat warts, which usually present with different sizes and shapes.
Patients with a history of allergic contact dermatitis may present with a generalized monomorphic eruption of skin-colored papules (known as ID reaction) that can sometimes be very similar to lichen nitidus. Allergic contact dermatitis tends to respond fairly quickly to topical or systemic corticosteroids, unlike lichen nitidus. There are a few reports that consider lichen nitidus to be a variant of lichen planus, although they have different histopathologic findings. Lichen planus lesions are described as polygonal, pruritic, purple to pink papules most commonly seen on the wrists, lower back, and ankles. Lichen planus can be seen in patients with hepatitis C and may also occur secondary to medication.
Milia are small keratin cysts on the skin that are commonly seen in babies as primary milia and can be seen in older children secondary to trauma (commonly on the eyelids) or medications. Given their size and monomorphic appearance, they can sometimes be confused with lichen nitidus.
Lichen nitidus is often asymptomatic and the lesions resolve within a few months to years. Topical corticosteroids can be helpful to alleviate the symptoms in patients who present with pruritus. In more persistent and generalized cases, phototherapy, systemic corticosteroids, acitretin, isotretinoin, or cyclosporine can be considered.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.
References
Chu J and Lam JM. CMAJ. 2014 Dec 9;186(18):E688.
Lestringant G et al. Dermatology 1996;192:171-3.
Peterson JA et al. Proc (Bayl Univ Med Cent). 2021 Aug 25;35(1):70-2.
Schwartz C and Goodman MB. “Lichen nitidus,” in StatPearls. Treasure Island, Fla.: StatPearls Publishing, 2022.
The patient was diagnosed with lichen nitidus, given the characteristic clinical presentation.
Lichen nitidus is a rare chronic inflammatory condition of the skin that most commonly presents in children and young adults and does not seem to be restricted to any sex or race. The classic lesions are described as asymptomatic to slightly pruritic, small (1 mm), skin-colored to hypopigmented flat-topped papules.
Koebner phenomenon is usually seen in which the skin lesions appear in areas of traumatized healthy skin. The extremities, abdomen, chest, and penis are common locations for the lesions to occur. Rarely, the oral mucosa or nails can be involved. It has been described in patients with a diagnosis of Crohn’s disease, Niemann-Pick disease, Down syndrome, and HIV. The rare, generalized purpuric variant has been reported in a few cases associated with interferon and ribavirin treatment for hepatitis C infection and nivolumab treatment for cancer. The pathophysiology of lichen nitidus is unknown.
Lichen nitidus can occur in the presence of other skin conditions like lichen planus, atopic dermatitis, vitiligo, erythema nodosum, and lichen spinulosus. Histopathologic characteristics of lichen nitidus are described as a “ball and claw” of epidermal rete around a lymphohistiocytic infiltrate. Parakeratosis overlying epidermal atrophy and focal basal liquefaction degeneration is also seen.
The differential diagnosis of lichen nitidus includes flat warts, which can present as clusters of small flat-topped papules that can show a pseudo-Koebner phenomenon (where the virus is seeded in traumatized skin). The morphological difference between the condition is that lichen nitidus lesions are usually monomorphic, compared with flat warts, which usually present with different sizes and shapes.
Patients with a history of allergic contact dermatitis may present with a generalized monomorphic eruption of skin-colored papules (known as ID reaction) that can sometimes be very similar to lichen nitidus. Allergic contact dermatitis tends to respond fairly quickly to topical or systemic corticosteroids, unlike lichen nitidus. There are a few reports that consider lichen nitidus to be a variant of lichen planus, although they have different histopathologic findings. Lichen planus lesions are described as polygonal, pruritic, purple to pink papules most commonly seen on the wrists, lower back, and ankles. Lichen planus can be seen in patients with hepatitis C and may also occur secondary to medication.
Milia are small keratin cysts on the skin that are commonly seen in babies as primary milia and can be seen in older children secondary to trauma (commonly on the eyelids) or medications. Given their size and monomorphic appearance, they can sometimes be confused with lichen nitidus.
Lichen nitidus is often asymptomatic and the lesions resolve within a few months to years. Topical corticosteroids can be helpful to alleviate the symptoms in patients who present with pruritus. In more persistent and generalized cases, phototherapy, systemic corticosteroids, acitretin, isotretinoin, or cyclosporine can be considered.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.
References
Chu J and Lam JM. CMAJ. 2014 Dec 9;186(18):E688.
Lestringant G et al. Dermatology 1996;192:171-3.
Peterson JA et al. Proc (Bayl Univ Med Cent). 2021 Aug 25;35(1):70-2.
Schwartz C and Goodman MB. “Lichen nitidus,” in StatPearls. Treasure Island, Fla.: StatPearls Publishing, 2022.
An 11-year-old male with a prior history of atopic dermatitis as a young child, presents with 6 months of slightly itchy, small bumps on the wrists, face, arms, and legs. Has been treated with fluocinolone oil and hydrocortisone 2.5% for a month with no change in the lesions. Besides the use of topical corticosteroids, he has not been taking any other medications.
On physical examination he has multiple skin-colored, flat-topped papules that coalesce into plaques on the arms, legs, chest, and back (Photo 1). Koebner phenomenon was also seen on the knees and arms. There were no lesions in the mouth or on the nails.
Doctors and dating: There’s an app (or three) for that
Pounding heart, sweating, insomnia. Surges of dopamine, norepinephrine, and adrenaline. All symptoms of a very common yet frustrating condition: Falling in love.
The prognosis is vague. A prescription pad and knowledge of biochemistry aren’t helpful when it comes to relationships.
Medical training can consume decades when others are exploring relationships and starting families. There are few recent data on this, but
But there is hope! By age 36, the number of doctors in long-term relationships had overtaken everyone else by more than 10% for women and 20% for men. The Medscape 2022 Physician Happiness & Lifestyle Report found that 83% were in committed relationships, and even better, happy ones. At least three-quarters of doctors in every specialty described their partnerships as “very good” or “good.”
How should a single medical student, resident, or attending physician find happiness ever after in 2023? Sometimes Mr./Ms. Right can be found in the anatomy lab or hospital, with sparks flying between students or colleagues. But for many in health care, along with millions of others looking for love, the solution is dating apps.
When ‘MD’ is a turnoff
Dr. M, a psychiatry resident in California who prefers not to give her name, hadn’t found a life partner during college, grad school, or medical school. When she passed her final Step 3 board exam, she decided it was time to take the plunge. She signed up for popular dating apps like Hinge, Bumble, and Coffee Meets Bagel, but her dates seemed to follow a disappointing pattern.
“I met lots of guys, but it was incredibly rare to find another physician,” said Dr. M. “I found myself always wanting to talk about my life as a resident. More often than not, the guys would give me this blank stare as I complained about being on call or spoke about spending 12 hours a day studying for a board exam, or even the process of The Match and how I ended up in California.”
Both of Dr. M’s parents are physicians, and she grew up watching how they supported each other through residency, exams, and exhausting schedules. A relationship with another physician, her parents told her, would give both partners the best chance to understand each other’s lives. The problem was how to find one.
That was when Dr. M saw an ad for a dating app with a cute medical name: DownToDate, a play on the clinical evidence resource UpToDate. “I thought it was a meme,” she said. “It was this doctors-only app. I remember thinking, ‘this has to be a joke,’ but then it was very real.”
She signed up and was required to provide a photo of her ID and her NPI number. Immediately, men began “requesting a consult,” the app’s form of “liking” her profile, and sending her “pages” (messages).
DownToDate was created by another physician, Robin Boyer, MD, MBA, a pediatrics resident in Loma Linda, Calif. The inspiration came in 2020 during the initial COVID crisis. Exhausted from long and often heartbreaking shifts, Dr. Boyer was grateful for her husband’s unwavering support. But many of her coresidents weren’t so lucky. The women in particular talked about their dating struggles, and there was a recurring theme. They didn’t feel confident putting “physician” on a dating site profile.
“If you’re male and you tell people you’re a doctor, it seems like it really attracts people,” Dr. Boyer said. “But if you’re female, it brings up a lot of stereotypes where you’re perceived as too intimidating either as the breadwinner, being more educated, or having a [demanding] career. It does make it more difficult.”
Dr. Boyer met her husband in high school, and she had never used a dating app. She convinced a coresident, Celestine Odigwe, MD, to pursue the idea as partners. They began researching the market within their network and heard from over a thousand interested physicians, both men and women, heterosexual and LGBTQ+. They even created fake accounts on other sites to gauge how easy it is to falsify a profile. From these insights, the app took shape. It launched in 2021 and currently has more than 5000 verified users.
Branches from the same tree
Around the same time that DownToDate began, Shivani Shah, DO, a pediatric neurology resident at Duke University, Durham, N.C., and her brother, Sagar Shah, an entrepreneur, had a similar idea.
At the time, Dr. Shah was a fourth-year medical student about to move from New Jersey to North Carolina. Friends who were internal medicine residents described the grueling reality of the early COVID pandemic.
“It was just horrible,” said Dr. Shah. “You were isolated from your family, your support system, everything. ... I think the pandemic really pushed us into realizing that this is a very important need, and sometimes it feels like community is lacking in the health care field.”
The sibling duo developed ForeverX, an app for health care workers to find meaningful and long-term romantic connections. It launched in 2021.
Concerned that the medical field was “siloed,” the Shahs chose to open the app to physicians, dentists, nurses, physical therapists, and other health care professionals. “Opening up the doors to more communication” between the health care branches was a priority.
To prevent catfishing, the app uses a twofold vetting system. Each user submits a photo of their driver’s license and a selfie that must match. There is also health care verification through an NPI number, nurse’s ID, or a manual process for those without either. None of the information is stored.
Through personal experience with dating apps, Dr. Shah hopes ForeverX can improve on some of their flaws, particularly the problem of matches being overly filtered by preferences. The “natural way” of meeting people is not filtered. And while most people have a dating checklist in mind, meeting someone face to face might send some of those prerequisites “out the window.”
“You can’t really put into words how you feel with someone ... the vibe,” Dr. Shah said. That is why her goal is to get people off the app and on an actual date IRL. “Something we’ve discussed internally is, how do we make this experience that’s virtual more human?”
She acknowledged that certain requirements, like a desire for children, might be crucial to some users. Many female doctors in their 30’s feel the “time crunch” of a ticking biological clock.
Optimize your date-ability
“I think people either love or hate dating apps, and I love them,” said Kevin Jubbal, MD. “I get to meet cool people and schedule dates from the comfort of my home.”
Dr. Jubbal, a former plastic surgery resident who left medicine to become an entrepreneur, is the founder of Med School Insiders, a tutoring and advising resource for premeds, medical students, and residents. His YouTube channel has more than 1.5 million subscribers, and he often receives questions about whether dating is feasible in medical school and how to balance a personal and academic/professional life.
Those who hate dating apps or receive few matches would do well to look inward instead of blaming the process, he said. It helps to view the experience as a learning tool that provides feedback very quickly.
“If you want to find a really amazing person, then you need to be what you want to find,” said Dr. Jubbal. “If you want to find someone who’s fit and intelligent and well read and well traveled, you need to be that. Otherwise, you’re probably not going to attract that person.”
An app designed to help single female MDs
Ifie Williams, MD, a psychiatrist in Washington, D.C., believes a wider dating pool is key – provided everyone understands the situation up front. When Dr. Williams started residency in 2014, she was “as single as can be.” She tried many dating apps, but they were extremely time consuming. Even when she set specific preferences, she found herself sifting through “matches” that didn’t fit her criteria.
“Dating nowadays has become almost like a second job,” said Dr. Williams. “Just the amount of time that people are having to spend on apps, swiping left and right and then meeting people. You think they’re interested and then you deal with all these games.”
By 2017, Dr. Williams had invented Miss Doctor, a dating app that would connect female physicians and other doctoral-level professionals with men or women on a similar achievement level.
By definition, these people would not be intimidated by ambitious, busy women. They would be heavily screened and vetted. And one other proviso: they would have to pay for “likes.”
Most dating apps charge a subscription fee. Users are allowed to “like” numerous profiles and perhaps not bother responding to many matches. By contrast, Miss Doctor accounts are free and include a limited number of “likes” to indicate interest. Beyond that, there’s a price.
“We wanted to find a way to make people a little more intentional with how they like people on the app, so they give a little more thought to it,” Dr. Williams said. “So, we monetize it and use that to change behavior.”
After an initial launch in 2017, the app had to take a back seat while Dr. Williams started her psychiatry practice and got married herself. She plans to relaunch it in spring 2023.
Male or female, there is general agreement that finding time to date as a young physician isn’t easy. While DownToDate has had “doctor meets doctor” success stories, many users are still searching for “the one.”
Dr. Boyer believes that career challenges are not a reason to give up. “There are so many single and available people out there,” she said. “And everyone’s deserving of love. Even if you only have an hour a week.”
A version of this article first appeared on Medscape.com.
Pounding heart, sweating, insomnia. Surges of dopamine, norepinephrine, and adrenaline. All symptoms of a very common yet frustrating condition: Falling in love.
The prognosis is vague. A prescription pad and knowledge of biochemistry aren’t helpful when it comes to relationships.
Medical training can consume decades when others are exploring relationships and starting families. There are few recent data on this, but
But there is hope! By age 36, the number of doctors in long-term relationships had overtaken everyone else by more than 10% for women and 20% for men. The Medscape 2022 Physician Happiness & Lifestyle Report found that 83% were in committed relationships, and even better, happy ones. At least three-quarters of doctors in every specialty described their partnerships as “very good” or “good.”
How should a single medical student, resident, or attending physician find happiness ever after in 2023? Sometimes Mr./Ms. Right can be found in the anatomy lab or hospital, with sparks flying between students or colleagues. But for many in health care, along with millions of others looking for love, the solution is dating apps.
When ‘MD’ is a turnoff
Dr. M, a psychiatry resident in California who prefers not to give her name, hadn’t found a life partner during college, grad school, or medical school. When she passed her final Step 3 board exam, she decided it was time to take the plunge. She signed up for popular dating apps like Hinge, Bumble, and Coffee Meets Bagel, but her dates seemed to follow a disappointing pattern.
“I met lots of guys, but it was incredibly rare to find another physician,” said Dr. M. “I found myself always wanting to talk about my life as a resident. More often than not, the guys would give me this blank stare as I complained about being on call or spoke about spending 12 hours a day studying for a board exam, or even the process of The Match and how I ended up in California.”
Both of Dr. M’s parents are physicians, and she grew up watching how they supported each other through residency, exams, and exhausting schedules. A relationship with another physician, her parents told her, would give both partners the best chance to understand each other’s lives. The problem was how to find one.
That was when Dr. M saw an ad for a dating app with a cute medical name: DownToDate, a play on the clinical evidence resource UpToDate. “I thought it was a meme,” she said. “It was this doctors-only app. I remember thinking, ‘this has to be a joke,’ but then it was very real.”
She signed up and was required to provide a photo of her ID and her NPI number. Immediately, men began “requesting a consult,” the app’s form of “liking” her profile, and sending her “pages” (messages).
DownToDate was created by another physician, Robin Boyer, MD, MBA, a pediatrics resident in Loma Linda, Calif. The inspiration came in 2020 during the initial COVID crisis. Exhausted from long and often heartbreaking shifts, Dr. Boyer was grateful for her husband’s unwavering support. But many of her coresidents weren’t so lucky. The women in particular talked about their dating struggles, and there was a recurring theme. They didn’t feel confident putting “physician” on a dating site profile.
“If you’re male and you tell people you’re a doctor, it seems like it really attracts people,” Dr. Boyer said. “But if you’re female, it brings up a lot of stereotypes where you’re perceived as too intimidating either as the breadwinner, being more educated, or having a [demanding] career. It does make it more difficult.”
Dr. Boyer met her husband in high school, and she had never used a dating app. She convinced a coresident, Celestine Odigwe, MD, to pursue the idea as partners. They began researching the market within their network and heard from over a thousand interested physicians, both men and women, heterosexual and LGBTQ+. They even created fake accounts on other sites to gauge how easy it is to falsify a profile. From these insights, the app took shape. It launched in 2021 and currently has more than 5000 verified users.
Branches from the same tree
Around the same time that DownToDate began, Shivani Shah, DO, a pediatric neurology resident at Duke University, Durham, N.C., and her brother, Sagar Shah, an entrepreneur, had a similar idea.
At the time, Dr. Shah was a fourth-year medical student about to move from New Jersey to North Carolina. Friends who were internal medicine residents described the grueling reality of the early COVID pandemic.
“It was just horrible,” said Dr. Shah. “You were isolated from your family, your support system, everything. ... I think the pandemic really pushed us into realizing that this is a very important need, and sometimes it feels like community is lacking in the health care field.”
The sibling duo developed ForeverX, an app for health care workers to find meaningful and long-term romantic connections. It launched in 2021.
Concerned that the medical field was “siloed,” the Shahs chose to open the app to physicians, dentists, nurses, physical therapists, and other health care professionals. “Opening up the doors to more communication” between the health care branches was a priority.
To prevent catfishing, the app uses a twofold vetting system. Each user submits a photo of their driver’s license and a selfie that must match. There is also health care verification through an NPI number, nurse’s ID, or a manual process for those without either. None of the information is stored.
Through personal experience with dating apps, Dr. Shah hopes ForeverX can improve on some of their flaws, particularly the problem of matches being overly filtered by preferences. The “natural way” of meeting people is not filtered. And while most people have a dating checklist in mind, meeting someone face to face might send some of those prerequisites “out the window.”
“You can’t really put into words how you feel with someone ... the vibe,” Dr. Shah said. That is why her goal is to get people off the app and on an actual date IRL. “Something we’ve discussed internally is, how do we make this experience that’s virtual more human?”
She acknowledged that certain requirements, like a desire for children, might be crucial to some users. Many female doctors in their 30’s feel the “time crunch” of a ticking biological clock.
Optimize your date-ability
“I think people either love or hate dating apps, and I love them,” said Kevin Jubbal, MD. “I get to meet cool people and schedule dates from the comfort of my home.”
Dr. Jubbal, a former plastic surgery resident who left medicine to become an entrepreneur, is the founder of Med School Insiders, a tutoring and advising resource for premeds, medical students, and residents. His YouTube channel has more than 1.5 million subscribers, and he often receives questions about whether dating is feasible in medical school and how to balance a personal and academic/professional life.
Those who hate dating apps or receive few matches would do well to look inward instead of blaming the process, he said. It helps to view the experience as a learning tool that provides feedback very quickly.
“If you want to find a really amazing person, then you need to be what you want to find,” said Dr. Jubbal. “If you want to find someone who’s fit and intelligent and well read and well traveled, you need to be that. Otherwise, you’re probably not going to attract that person.”
An app designed to help single female MDs
Ifie Williams, MD, a psychiatrist in Washington, D.C., believes a wider dating pool is key – provided everyone understands the situation up front. When Dr. Williams started residency in 2014, she was “as single as can be.” She tried many dating apps, but they were extremely time consuming. Even when she set specific preferences, she found herself sifting through “matches” that didn’t fit her criteria.
“Dating nowadays has become almost like a second job,” said Dr. Williams. “Just the amount of time that people are having to spend on apps, swiping left and right and then meeting people. You think they’re interested and then you deal with all these games.”
By 2017, Dr. Williams had invented Miss Doctor, a dating app that would connect female physicians and other doctoral-level professionals with men or women on a similar achievement level.
By definition, these people would not be intimidated by ambitious, busy women. They would be heavily screened and vetted. And one other proviso: they would have to pay for “likes.”
Most dating apps charge a subscription fee. Users are allowed to “like” numerous profiles and perhaps not bother responding to many matches. By contrast, Miss Doctor accounts are free and include a limited number of “likes” to indicate interest. Beyond that, there’s a price.
“We wanted to find a way to make people a little more intentional with how they like people on the app, so they give a little more thought to it,” Dr. Williams said. “So, we monetize it and use that to change behavior.”
After an initial launch in 2017, the app had to take a back seat while Dr. Williams started her psychiatry practice and got married herself. She plans to relaunch it in spring 2023.
Male or female, there is general agreement that finding time to date as a young physician isn’t easy. While DownToDate has had “doctor meets doctor” success stories, many users are still searching for “the one.”
Dr. Boyer believes that career challenges are not a reason to give up. “There are so many single and available people out there,” she said. “And everyone’s deserving of love. Even if you only have an hour a week.”
A version of this article first appeared on Medscape.com.
Pounding heart, sweating, insomnia. Surges of dopamine, norepinephrine, and adrenaline. All symptoms of a very common yet frustrating condition: Falling in love.
The prognosis is vague. A prescription pad and knowledge of biochemistry aren’t helpful when it comes to relationships.
Medical training can consume decades when others are exploring relationships and starting families. There are few recent data on this, but
But there is hope! By age 36, the number of doctors in long-term relationships had overtaken everyone else by more than 10% for women and 20% for men. The Medscape 2022 Physician Happiness & Lifestyle Report found that 83% were in committed relationships, and even better, happy ones. At least three-quarters of doctors in every specialty described their partnerships as “very good” or “good.”
How should a single medical student, resident, or attending physician find happiness ever after in 2023? Sometimes Mr./Ms. Right can be found in the anatomy lab or hospital, with sparks flying between students or colleagues. But for many in health care, along with millions of others looking for love, the solution is dating apps.
When ‘MD’ is a turnoff
Dr. M, a psychiatry resident in California who prefers not to give her name, hadn’t found a life partner during college, grad school, or medical school. When she passed her final Step 3 board exam, she decided it was time to take the plunge. She signed up for popular dating apps like Hinge, Bumble, and Coffee Meets Bagel, but her dates seemed to follow a disappointing pattern.
“I met lots of guys, but it was incredibly rare to find another physician,” said Dr. M. “I found myself always wanting to talk about my life as a resident. More often than not, the guys would give me this blank stare as I complained about being on call or spoke about spending 12 hours a day studying for a board exam, or even the process of The Match and how I ended up in California.”
Both of Dr. M’s parents are physicians, and she grew up watching how they supported each other through residency, exams, and exhausting schedules. A relationship with another physician, her parents told her, would give both partners the best chance to understand each other’s lives. The problem was how to find one.
That was when Dr. M saw an ad for a dating app with a cute medical name: DownToDate, a play on the clinical evidence resource UpToDate. “I thought it was a meme,” she said. “It was this doctors-only app. I remember thinking, ‘this has to be a joke,’ but then it was very real.”
She signed up and was required to provide a photo of her ID and her NPI number. Immediately, men began “requesting a consult,” the app’s form of “liking” her profile, and sending her “pages” (messages).
DownToDate was created by another physician, Robin Boyer, MD, MBA, a pediatrics resident in Loma Linda, Calif. The inspiration came in 2020 during the initial COVID crisis. Exhausted from long and often heartbreaking shifts, Dr. Boyer was grateful for her husband’s unwavering support. But many of her coresidents weren’t so lucky. The women in particular talked about their dating struggles, and there was a recurring theme. They didn’t feel confident putting “physician” on a dating site profile.
“If you’re male and you tell people you’re a doctor, it seems like it really attracts people,” Dr. Boyer said. “But if you’re female, it brings up a lot of stereotypes where you’re perceived as too intimidating either as the breadwinner, being more educated, or having a [demanding] career. It does make it more difficult.”
Dr. Boyer met her husband in high school, and she had never used a dating app. She convinced a coresident, Celestine Odigwe, MD, to pursue the idea as partners. They began researching the market within their network and heard from over a thousand interested physicians, both men and women, heterosexual and LGBTQ+. They even created fake accounts on other sites to gauge how easy it is to falsify a profile. From these insights, the app took shape. It launched in 2021 and currently has more than 5000 verified users.
Branches from the same tree
Around the same time that DownToDate began, Shivani Shah, DO, a pediatric neurology resident at Duke University, Durham, N.C., and her brother, Sagar Shah, an entrepreneur, had a similar idea.
At the time, Dr. Shah was a fourth-year medical student about to move from New Jersey to North Carolina. Friends who were internal medicine residents described the grueling reality of the early COVID pandemic.
“It was just horrible,” said Dr. Shah. “You were isolated from your family, your support system, everything. ... I think the pandemic really pushed us into realizing that this is a very important need, and sometimes it feels like community is lacking in the health care field.”
The sibling duo developed ForeverX, an app for health care workers to find meaningful and long-term romantic connections. It launched in 2021.
Concerned that the medical field was “siloed,” the Shahs chose to open the app to physicians, dentists, nurses, physical therapists, and other health care professionals. “Opening up the doors to more communication” between the health care branches was a priority.
To prevent catfishing, the app uses a twofold vetting system. Each user submits a photo of their driver’s license and a selfie that must match. There is also health care verification through an NPI number, nurse’s ID, or a manual process for those without either. None of the information is stored.
Through personal experience with dating apps, Dr. Shah hopes ForeverX can improve on some of their flaws, particularly the problem of matches being overly filtered by preferences. The “natural way” of meeting people is not filtered. And while most people have a dating checklist in mind, meeting someone face to face might send some of those prerequisites “out the window.”
“You can’t really put into words how you feel with someone ... the vibe,” Dr. Shah said. That is why her goal is to get people off the app and on an actual date IRL. “Something we’ve discussed internally is, how do we make this experience that’s virtual more human?”
She acknowledged that certain requirements, like a desire for children, might be crucial to some users. Many female doctors in their 30’s feel the “time crunch” of a ticking biological clock.
Optimize your date-ability
“I think people either love or hate dating apps, and I love them,” said Kevin Jubbal, MD. “I get to meet cool people and schedule dates from the comfort of my home.”
Dr. Jubbal, a former plastic surgery resident who left medicine to become an entrepreneur, is the founder of Med School Insiders, a tutoring and advising resource for premeds, medical students, and residents. His YouTube channel has more than 1.5 million subscribers, and he often receives questions about whether dating is feasible in medical school and how to balance a personal and academic/professional life.
Those who hate dating apps or receive few matches would do well to look inward instead of blaming the process, he said. It helps to view the experience as a learning tool that provides feedback very quickly.
“If you want to find a really amazing person, then you need to be what you want to find,” said Dr. Jubbal. “If you want to find someone who’s fit and intelligent and well read and well traveled, you need to be that. Otherwise, you’re probably not going to attract that person.”
An app designed to help single female MDs
Ifie Williams, MD, a psychiatrist in Washington, D.C., believes a wider dating pool is key – provided everyone understands the situation up front. When Dr. Williams started residency in 2014, she was “as single as can be.” She tried many dating apps, but they were extremely time consuming. Even when she set specific preferences, she found herself sifting through “matches” that didn’t fit her criteria.
“Dating nowadays has become almost like a second job,” said Dr. Williams. “Just the amount of time that people are having to spend on apps, swiping left and right and then meeting people. You think they’re interested and then you deal with all these games.”
By 2017, Dr. Williams had invented Miss Doctor, a dating app that would connect female physicians and other doctoral-level professionals with men or women on a similar achievement level.
By definition, these people would not be intimidated by ambitious, busy women. They would be heavily screened and vetted. And one other proviso: they would have to pay for “likes.”
Most dating apps charge a subscription fee. Users are allowed to “like” numerous profiles and perhaps not bother responding to many matches. By contrast, Miss Doctor accounts are free and include a limited number of “likes” to indicate interest. Beyond that, there’s a price.
“We wanted to find a way to make people a little more intentional with how they like people on the app, so they give a little more thought to it,” Dr. Williams said. “So, we monetize it and use that to change behavior.”
After an initial launch in 2017, the app had to take a back seat while Dr. Williams started her psychiatry practice and got married herself. She plans to relaunch it in spring 2023.
Male or female, there is general agreement that finding time to date as a young physician isn’t easy. While DownToDate has had “doctor meets doctor” success stories, many users are still searching for “the one.”
Dr. Boyer believes that career challenges are not a reason to give up. “There are so many single and available people out there,” she said. “And everyone’s deserving of love. Even if you only have an hour a week.”
A version of this article first appeared on Medscape.com.
NICU use up, birth weights down in babies of mothers with HCV
Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.
Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”
For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).
The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.
An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.
There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).
No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.
“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.
She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”
Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”
As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”
At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”
The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).
Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.
Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”
For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).
The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.
An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.
There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).
No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.
“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.
She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”
Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”
As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”
At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”
The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).
Infants born to women infected with the hepatitis C virus (HCV) faced twice the risk of stays in the neonatal ICU (NICU) and 2.7 times the risk of low birth weight, a new analysis finds, even when researchers adjusted their data to control for injectable drug use and maternal medical comorbidity.
Clinicians should be “aware that the infants of pregnant people with HCV may have a high rate of need for higher-level pediatric care,” said Brenna L. Hughes, MD, MSc, chief of maternal fetal medicine at Duke University Medical Center, Durham, N.C. She spoke in an interview about the findings, which were presented at the meeting sponsored by the Society for Maternal-Fetal Medicine.
As Dr. Hughes noted, “HCV remains a serious problem in pregnancy because it often goes undiagnosed and/or untreated prior to pregnancy. It can be passed to infants, and this can cause significant health-related outcomes for children as they age.”
For the multicenter U.S. study, researchers identified 249 pregnant mothers with HCV from a 2012-2018 cohort and matched them by gestational age to controls (n = 486). The average age was 28; 71.1% of the cases were non-Hispanic White versus 41.6% of the controls; 8.4% of cases were non-Hispanic Black versus 32.1% of controls (P < .001 for race/ethnicity analysis); and 73% of cases were smokers versus 18% of controls (P < .001). More than 19% of cases reported injectable drug use during pregnancy versus 0.2% of controls (P < .001).
The researchers adjusted their findings for maternal age, body mass index, injectable drug use, and maternal comorbidity.
An earlier analysis of the study data found that 6% of pregnant women with HCV passed it on to their infants, especially those with high levels of virus in their systems. For the new study, researchers focused on various outcomes to test the assumption that “adverse pregnancy outcomes associated with HCV are related to prematurity or to ongoing use of injection drugs,” Dr. Hughes said.
There was no increase in rates of preterm birth or adverse maternal outcomes in the HCV cases. However, infants born to women with HCV were more likely than the controls to require a stay in the NICU (45% vs. 19%; adjusted relative risk, 1.99; 95% confidence interval, 1.54-2.58). They were also more likely to have lower birth weights (small for gestational age < 5th percentile) (10.6% vs. 3.1%; ARR, 2.72; 95% CI, 1.38-5.34).
No difference in outcomes was seen when HCV cases with viremia (33%) were excluded.
“The most surprising finding was that the need for higher-level pediatric care was so high even though there wasn’t an increased risk of prematurity,” Dr. Hughes said.
She added it’s not clear why NICU stays and low birth weights were more common in infants of women with HCV. “It is possible that the higher risk of need for higher-level pediatric care was related to a need for observation or treatment due to use of opioid replacement therapies with opioid agonists.” As for lower birth weight, “there may be other unmeasured risk factors.”
Tatyana Kushner, MD, MSCE, of the division of liver diseases at Icahn School of Medicine at Mount Sinai, New York, said in an interview that the study adds to limited data about HCV in pregnancy. “These findings have been demonstrated in prior studies, and it would be important to tease apart whether [low birth weight] is related to the virus itself or more related to other confounding associated factors such as maternal substance use as well as other associated social determinants of health among women with HCV.”
As for the study’s message, Dr. Kushner said it makes it clear that “hepatitis C adversely impacts outcomes of pregnancy and it is important to identify women of childbearing age for treatment early, ideally prior to pregnancy, in order to improve their pregnancy outcomes. In addition, treatment of hepatitis C during pregnancy should be explored further to determine if treatment during pregnancy can improve outcomes.”
At the moment, she said, “there are ongoing studies to delineate the safety and efficacy of hepatitis C treatment during pregnancy. Given that we are screening for hepatitis C during pregnancy, we need clear recommendations on the use of direct-acting antivirals in people who screen positive.”
The study was funded by the National Institute of Child Health and Human Development. The authors have no disclosures. Dr. Kushner disclosed research support (Gilead) and advisory board service (Gilead, AbbVie, Bausch, GlaxoSmithKline, and Eiger).
FROM THE PREGNANCY MEETING
Embattled iPLEDGE program: Changes ahead?
In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.
The risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”
Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.
Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.
However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.
(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)
Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.
In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.
The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.
“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.
As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.
The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.
A version of this article first appeared on Medscape.com.
In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.
The risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”
Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.
Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.
However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.
(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)
Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.
In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.
The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.
“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.
As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.
The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.
A version of this article first appeared on Medscape.com.
In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.
The risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”
Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.
Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.
However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.
(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)
Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.
In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.
The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.
“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.
As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.
The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.
A version of this article first appeared on Medscape.com.