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Fed Pract
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gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
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Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
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pedophilia
poker
porn
pornography
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recreational drug
sex slave rings
slot machine
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Texas hold 'em
UFC
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bunges
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butt
butt fuck
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buttfucked
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cock sucker
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.

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Will a mindfulness approach to depression boost recovery rates, reduce costs?

Article Type
Changed

A self-led, practitioner-supported form of mindfulness therapy was more effective and more cost-effective than self-help cognitive-behavioral therapy (CBT-SH), results from a head-to-head study show.

Self-help mindfulness-based cognitive therapy (MBCT-SH) produced better outcomes for participants with depression and was more cost-effective than CBT-SH.

Practitioner-supported self-help therapy regimens are growing in popularity as a way to expand access to mental health services and to address the shortage of mental health professionals.

Generally, mindfulness-based cognitive therapy aims to increase awareness of the depression maintenance cycle while fostering a nonjudgmental attitude toward present-moment experiences, the investigators note.

In contrast, CBT aims to challenge negative and unrealistic thought patterns that may perpetuate depression, replacing them with more realistic and objective thoughts.

“Practitioner-supported MBCT-SH should be routinely offered as an intervention for mild to moderate depression alongside practitioner-supported CBT-SH,” the investigators note.

The study was published online in JAMA Psychiatry.
 

Better recovery rates?

CBT-SH traditionally had been associated with high attrition rates, and alternative forms of self-help therapy are becoming increasingly necessary to fill this treatment gap, the researchers note. To compare the efficacy and cost-effectiveness of both treatment types, the researchers recruited 410 participants with mild to moderate depression at 10 sites in the United Kingdom. Participants were randomly assigned to receive either MBCT-SH or CBT-SH between November 2017 and January 2020. A total of 204 participants received MBCT-SH, and 206 received CBT-SH.

All participants were given specific self-help workbooks, depending on the study group to which they were assigned. Those who received MBCT-SH used “The Mindful Way Workbook: An 8-Week Program to Free Yourself From Depression and Emotional Distress,” while those who received CBT-SH used “Overcoming Depression and Low Mood: A Five Areas Approach, 3rd Edition.”

Investigators asked all participants to guide themselves through six 30- to 45-minute sessions, using the information in the workbooks. Trained psychological well-being practitioners supported participants as they moved through the workbooks during the six sessions.

Participants were assessed at baseline with the Patient Health Questionnaire–9 (PHQ-9) and the Clinical Interview Schedule–Revised at 16 weeks and 24 weeks.

At 16 weeks post randomization, results showed that practitioner-supported MBCT-SH led to significantly greater reductions in depression symptom severity, compared with practitioner-supported CBT-SH (mean [standard deviation] PHQ-9 score, 7.2 [4.8] points vs. 8.6 [5.5] points; between-group difference, –1.5 points; 95% confidence interval, –2.6 to –0.4; P = .009).

Results also showed that on average, the CBT-SH intervention cost $631 more per participant than the MBCT-SH intervention over the 42-week follow-up.

The investigators explain that “a substantial proportion of this additional cost was accounted for by additional face-to-face individual psychological therapy accessed by CBT-SH participants outside of the study intervention.

“In conclusion, this study found that a novel intervention, practitioner-supported MBCT-SH, was clinically superior in targeting depressive symptom severity at postintervention and cost-effective, compared with the criterion standard of practitioner-supported CBT-SH for adults experiencing mild to moderate depression,” the investigators write.

“If study findings are translated into routine practice, this would see many more people recovering from depression while costing health services less money,” they add.
 

Clinically meaningful?

 

 

Commenting on the study for this article, Lauren Bylsma, PhD, professor of psychiatry and psychology at the University of Pittsburgh, cast doubt on the ability of such a short trial to determine meaningful change.

She said that the extra costs incurred by participants in the CBT-SH arm of the study are likely, since it is “difficult to do CBT alone – you need an objective person to guide you as you practice.”

Dr. Bylsma noted that ultimately, more real-world studies of therapy are needed, given the great need for mental health.

The study was funded by the National Institute for Health and Care Research. The original article contains a full list of the authors’ relevant financial relationships.

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

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A self-led, practitioner-supported form of mindfulness therapy was more effective and more cost-effective than self-help cognitive-behavioral therapy (CBT-SH), results from a head-to-head study show.

Self-help mindfulness-based cognitive therapy (MBCT-SH) produced better outcomes for participants with depression and was more cost-effective than CBT-SH.

Practitioner-supported self-help therapy regimens are growing in popularity as a way to expand access to mental health services and to address the shortage of mental health professionals.

Generally, mindfulness-based cognitive therapy aims to increase awareness of the depression maintenance cycle while fostering a nonjudgmental attitude toward present-moment experiences, the investigators note.

In contrast, CBT aims to challenge negative and unrealistic thought patterns that may perpetuate depression, replacing them with more realistic and objective thoughts.

“Practitioner-supported MBCT-SH should be routinely offered as an intervention for mild to moderate depression alongside practitioner-supported CBT-SH,” the investigators note.

The study was published online in JAMA Psychiatry.
 

Better recovery rates?

CBT-SH traditionally had been associated with high attrition rates, and alternative forms of self-help therapy are becoming increasingly necessary to fill this treatment gap, the researchers note. To compare the efficacy and cost-effectiveness of both treatment types, the researchers recruited 410 participants with mild to moderate depression at 10 sites in the United Kingdom. Participants were randomly assigned to receive either MBCT-SH or CBT-SH between November 2017 and January 2020. A total of 204 participants received MBCT-SH, and 206 received CBT-SH.

All participants were given specific self-help workbooks, depending on the study group to which they were assigned. Those who received MBCT-SH used “The Mindful Way Workbook: An 8-Week Program to Free Yourself From Depression and Emotional Distress,” while those who received CBT-SH used “Overcoming Depression and Low Mood: A Five Areas Approach, 3rd Edition.”

Investigators asked all participants to guide themselves through six 30- to 45-minute sessions, using the information in the workbooks. Trained psychological well-being practitioners supported participants as they moved through the workbooks during the six sessions.

Participants were assessed at baseline with the Patient Health Questionnaire–9 (PHQ-9) and the Clinical Interview Schedule–Revised at 16 weeks and 24 weeks.

At 16 weeks post randomization, results showed that practitioner-supported MBCT-SH led to significantly greater reductions in depression symptom severity, compared with practitioner-supported CBT-SH (mean [standard deviation] PHQ-9 score, 7.2 [4.8] points vs. 8.6 [5.5] points; between-group difference, –1.5 points; 95% confidence interval, –2.6 to –0.4; P = .009).

Results also showed that on average, the CBT-SH intervention cost $631 more per participant than the MBCT-SH intervention over the 42-week follow-up.

The investigators explain that “a substantial proportion of this additional cost was accounted for by additional face-to-face individual psychological therapy accessed by CBT-SH participants outside of the study intervention.

“In conclusion, this study found that a novel intervention, practitioner-supported MBCT-SH, was clinically superior in targeting depressive symptom severity at postintervention and cost-effective, compared with the criterion standard of practitioner-supported CBT-SH for adults experiencing mild to moderate depression,” the investigators write.

“If study findings are translated into routine practice, this would see many more people recovering from depression while costing health services less money,” they add.
 

Clinically meaningful?

 

 

Commenting on the study for this article, Lauren Bylsma, PhD, professor of psychiatry and psychology at the University of Pittsburgh, cast doubt on the ability of such a short trial to determine meaningful change.

She said that the extra costs incurred by participants in the CBT-SH arm of the study are likely, since it is “difficult to do CBT alone – you need an objective person to guide you as you practice.”

Dr. Bylsma noted that ultimately, more real-world studies of therapy are needed, given the great need for mental health.

The study was funded by the National Institute for Health and Care Research. The original article contains a full list of the authors’ relevant financial relationships.

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

A self-led, practitioner-supported form of mindfulness therapy was more effective and more cost-effective than self-help cognitive-behavioral therapy (CBT-SH), results from a head-to-head study show.

Self-help mindfulness-based cognitive therapy (MBCT-SH) produced better outcomes for participants with depression and was more cost-effective than CBT-SH.

Practitioner-supported self-help therapy regimens are growing in popularity as a way to expand access to mental health services and to address the shortage of mental health professionals.

Generally, mindfulness-based cognitive therapy aims to increase awareness of the depression maintenance cycle while fostering a nonjudgmental attitude toward present-moment experiences, the investigators note.

In contrast, CBT aims to challenge negative and unrealistic thought patterns that may perpetuate depression, replacing them with more realistic and objective thoughts.

“Practitioner-supported MBCT-SH should be routinely offered as an intervention for mild to moderate depression alongside practitioner-supported CBT-SH,” the investigators note.

The study was published online in JAMA Psychiatry.
 

Better recovery rates?

CBT-SH traditionally had been associated with high attrition rates, and alternative forms of self-help therapy are becoming increasingly necessary to fill this treatment gap, the researchers note. To compare the efficacy and cost-effectiveness of both treatment types, the researchers recruited 410 participants with mild to moderate depression at 10 sites in the United Kingdom. Participants were randomly assigned to receive either MBCT-SH or CBT-SH between November 2017 and January 2020. A total of 204 participants received MBCT-SH, and 206 received CBT-SH.

All participants were given specific self-help workbooks, depending on the study group to which they were assigned. Those who received MBCT-SH used “The Mindful Way Workbook: An 8-Week Program to Free Yourself From Depression and Emotional Distress,” while those who received CBT-SH used “Overcoming Depression and Low Mood: A Five Areas Approach, 3rd Edition.”

Investigators asked all participants to guide themselves through six 30- to 45-minute sessions, using the information in the workbooks. Trained psychological well-being practitioners supported participants as they moved through the workbooks during the six sessions.

Participants were assessed at baseline with the Patient Health Questionnaire–9 (PHQ-9) and the Clinical Interview Schedule–Revised at 16 weeks and 24 weeks.

At 16 weeks post randomization, results showed that practitioner-supported MBCT-SH led to significantly greater reductions in depression symptom severity, compared with practitioner-supported CBT-SH (mean [standard deviation] PHQ-9 score, 7.2 [4.8] points vs. 8.6 [5.5] points; between-group difference, –1.5 points; 95% confidence interval, –2.6 to –0.4; P = .009).

Results also showed that on average, the CBT-SH intervention cost $631 more per participant than the MBCT-SH intervention over the 42-week follow-up.

The investigators explain that “a substantial proportion of this additional cost was accounted for by additional face-to-face individual psychological therapy accessed by CBT-SH participants outside of the study intervention.

“In conclusion, this study found that a novel intervention, practitioner-supported MBCT-SH, was clinically superior in targeting depressive symptom severity at postintervention and cost-effective, compared with the criterion standard of practitioner-supported CBT-SH for adults experiencing mild to moderate depression,” the investigators write.

“If study findings are translated into routine practice, this would see many more people recovering from depression while costing health services less money,” they add.
 

Clinically meaningful?

 

 

Commenting on the study for this article, Lauren Bylsma, PhD, professor of psychiatry and psychology at the University of Pittsburgh, cast doubt on the ability of such a short trial to determine meaningful change.

She said that the extra costs incurred by participants in the CBT-SH arm of the study are likely, since it is “difficult to do CBT alone – you need an objective person to guide you as you practice.”

Dr. Bylsma noted that ultimately, more real-world studies of therapy are needed, given the great need for mental health.

The study was funded by the National Institute for Health and Care Research. The original article contains a full list of the authors’ relevant financial relationships.

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

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Prior authorization has radiation oncologist deferring to business manager

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“What am I allowed to do?” radiation oncologist Vivek Kavadi, MD, asked the business manager at Texas Oncology in Sugar Land, Tex.

Dr. Kavadi wanted to give his patient with early-stage breast cancer a standard radiation treatment – hypofractionated 3D conformal radiation therapy – following her lumpectomy.

But his hands were tied.

Dr. Kavadi had submitted a prior authorization request, but the patient’s health insurance was dragging its feet. And without prior authorization, Dr. Kavadi couldn’t schedule his patient’s first treatment.

“I chose the most cost-effective, standard treatment, but nothing could begin without the insurance company’s permission,” he said.

One of the most challenging aspects of the delay was explaining to his patient why he couldn’t schedule her treatment. “We would love to start, but your insurance company has not given us approval. The best I can do is give you a tentative appointment,” he recalled telling her.

After a few days with no word, calls to the insurance company began. “My patient called, I called, my office called,” Dr. Kavadi said. “It was a week or more of aggravation, stress, and time wasted for my patient and my team.”

This type of delay has become increasingly common in radiation oncology. One recent analysis estimated that 97% of radiation oncology services now require prior authorization under Medicare Advantage. And another analysis found that almost all radiation oncologists said prior authorization delays life-saving care for their patients.

The rise of prior authorization requirements may boil down to the fact that prior authorization is no longer reserved for uncertain or high-cost care. Terrence Cunningham, director of administrative simplification policy for the American Hospital Association, told this news organization last year that “prior authorization used to be applied only to new, costly, or high-risk services,” but now “many insurers require authorizations for even routine care, which is inappropriate.”

The growth of prior authorization requirements has forced many doctors, nurses, and pharmacists to dedicate part of their workday to handling requests and appealing denials and has forced many practices to hire staff exclusively for prior authorizations.

This additional work is costly.

One recent study found that the radiation oncology department of Vanderbilt University, Nashville, Tenn., spent nearly $500,000 annually in employee time to obtain prior authorization for radiation therapy treatments. Extrapolated nationally, the researchers estimated that physicians’ annual compensation for prior authorization duties came to an estimated $46 million. Overall, 86% of these costs were for treatments that were ultimately approved, the majority on initial request and some on appeal.

Dr. Kavadi has five full-time employees dedicated to managing prior authorization requests and challenges.

And after a week of delays and hours on the phone with the insurer, his patient’s radiation treatment was ultimately approved.

Dr. Kavadi wondered why something so simple needed to be so onerous.

Stretching out an approval for a standard radiation treatment “feels like a means of intentionally delaying care,” Dr. Kavadi said. “This is an example of a process that has run so far amok. It’s just a burden across the board.”

And even with his 30 years of experience, “I still have to ask my business supervisor what I am allowed to do,” he said. “I can’t just proceed with what’s best for my patient, what the patient has consented to, and what also happens to be the least expensive option.”

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

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“What am I allowed to do?” radiation oncologist Vivek Kavadi, MD, asked the business manager at Texas Oncology in Sugar Land, Tex.

Dr. Kavadi wanted to give his patient with early-stage breast cancer a standard radiation treatment – hypofractionated 3D conformal radiation therapy – following her lumpectomy.

But his hands were tied.

Dr. Kavadi had submitted a prior authorization request, but the patient’s health insurance was dragging its feet. And without prior authorization, Dr. Kavadi couldn’t schedule his patient’s first treatment.

“I chose the most cost-effective, standard treatment, but nothing could begin without the insurance company’s permission,” he said.

One of the most challenging aspects of the delay was explaining to his patient why he couldn’t schedule her treatment. “We would love to start, but your insurance company has not given us approval. The best I can do is give you a tentative appointment,” he recalled telling her.

After a few days with no word, calls to the insurance company began. “My patient called, I called, my office called,” Dr. Kavadi said. “It was a week or more of aggravation, stress, and time wasted for my patient and my team.”

This type of delay has become increasingly common in radiation oncology. One recent analysis estimated that 97% of radiation oncology services now require prior authorization under Medicare Advantage. And another analysis found that almost all radiation oncologists said prior authorization delays life-saving care for their patients.

The rise of prior authorization requirements may boil down to the fact that prior authorization is no longer reserved for uncertain or high-cost care. Terrence Cunningham, director of administrative simplification policy for the American Hospital Association, told this news organization last year that “prior authorization used to be applied only to new, costly, or high-risk services,” but now “many insurers require authorizations for even routine care, which is inappropriate.”

The growth of prior authorization requirements has forced many doctors, nurses, and pharmacists to dedicate part of their workday to handling requests and appealing denials and has forced many practices to hire staff exclusively for prior authorizations.

This additional work is costly.

One recent study found that the radiation oncology department of Vanderbilt University, Nashville, Tenn., spent nearly $500,000 annually in employee time to obtain prior authorization for radiation therapy treatments. Extrapolated nationally, the researchers estimated that physicians’ annual compensation for prior authorization duties came to an estimated $46 million. Overall, 86% of these costs were for treatments that were ultimately approved, the majority on initial request and some on appeal.

Dr. Kavadi has five full-time employees dedicated to managing prior authorization requests and challenges.

And after a week of delays and hours on the phone with the insurer, his patient’s radiation treatment was ultimately approved.

Dr. Kavadi wondered why something so simple needed to be so onerous.

Stretching out an approval for a standard radiation treatment “feels like a means of intentionally delaying care,” Dr. Kavadi said. “This is an example of a process that has run so far amok. It’s just a burden across the board.”

And even with his 30 years of experience, “I still have to ask my business supervisor what I am allowed to do,” he said. “I can’t just proceed with what’s best for my patient, what the patient has consented to, and what also happens to be the least expensive option.”

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

“What am I allowed to do?” radiation oncologist Vivek Kavadi, MD, asked the business manager at Texas Oncology in Sugar Land, Tex.

Dr. Kavadi wanted to give his patient with early-stage breast cancer a standard radiation treatment – hypofractionated 3D conformal radiation therapy – following her lumpectomy.

But his hands were tied.

Dr. Kavadi had submitted a prior authorization request, but the patient’s health insurance was dragging its feet. And without prior authorization, Dr. Kavadi couldn’t schedule his patient’s first treatment.

“I chose the most cost-effective, standard treatment, but nothing could begin without the insurance company’s permission,” he said.

One of the most challenging aspects of the delay was explaining to his patient why he couldn’t schedule her treatment. “We would love to start, but your insurance company has not given us approval. The best I can do is give you a tentative appointment,” he recalled telling her.

After a few days with no word, calls to the insurance company began. “My patient called, I called, my office called,” Dr. Kavadi said. “It was a week or more of aggravation, stress, and time wasted for my patient and my team.”

This type of delay has become increasingly common in radiation oncology. One recent analysis estimated that 97% of radiation oncology services now require prior authorization under Medicare Advantage. And another analysis found that almost all radiation oncologists said prior authorization delays life-saving care for their patients.

The rise of prior authorization requirements may boil down to the fact that prior authorization is no longer reserved for uncertain or high-cost care. Terrence Cunningham, director of administrative simplification policy for the American Hospital Association, told this news organization last year that “prior authorization used to be applied only to new, costly, or high-risk services,” but now “many insurers require authorizations for even routine care, which is inappropriate.”

The growth of prior authorization requirements has forced many doctors, nurses, and pharmacists to dedicate part of their workday to handling requests and appealing denials and has forced many practices to hire staff exclusively for prior authorizations.

This additional work is costly.

One recent study found that the radiation oncology department of Vanderbilt University, Nashville, Tenn., spent nearly $500,000 annually in employee time to obtain prior authorization for radiation therapy treatments. Extrapolated nationally, the researchers estimated that physicians’ annual compensation for prior authorization duties came to an estimated $46 million. Overall, 86% of these costs were for treatments that were ultimately approved, the majority on initial request and some on appeal.

Dr. Kavadi has five full-time employees dedicated to managing prior authorization requests and challenges.

And after a week of delays and hours on the phone with the insurer, his patient’s radiation treatment was ultimately approved.

Dr. Kavadi wondered why something so simple needed to be so onerous.

Stretching out an approval for a standard radiation treatment “feels like a means of intentionally delaying care,” Dr. Kavadi said. “This is an example of a process that has run so far amok. It’s just a burden across the board.”

And even with his 30 years of experience, “I still have to ask my business supervisor what I am allowed to do,” he said. “I can’t just proceed with what’s best for my patient, what the patient has consented to, and what also happens to be the least expensive option.”

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

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How providers are adjusting to clinical care post PHE

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The first day of seeing patients without a mask was, for Sterling Ransone Jr., MD, “unsettling.” 

“I can’t tell you how weird it was the first day that I walked down the hall from my office to where my exam rooms are, to not have a mask on after 3 years of the habit,” said Dr. Ransone, a family physician in Deltaville, Va., and board chair of the American Academy of Family Physicians. 

The White House recently lifted the public health emergency order that overhauled the way health care providers operated and advised patients over the past 3 years. The new postpandemic era will require clinicians and staff to once again adjust. 

For Dr. Ransone, this transition entails getting used to his bare face, reminding patients of the latest and varying symptoms of the virus, and parting ways with sick patients if they refuse to wear a mask.

As states, hospitals, and health care systems around the country relax their mask mandates for care providers, clinicians will have to fall back on their own policies that patients with potential symptoms mask up. 

“Now that it’s up to our offices, we have to have a little bit more backbone,” Dr. Ransone said. “If they’re not willing to follow a health-related policy that will protect the vulnerable, we will not see them. And so for us, it’s been pretty straightforward.”

Despite the policy, Dr. Ransone has cared for patients who don’t disclose they are feeling sick until he enters the room. 

“And I wasn’t masked,” Dr. Ransone said. So, “I will wear masks for the rest of the day just to try to protect the rest of my patients in case I was exposed.”

Masks are optional for both patients and staff at the University of Maryland Medical System, but Niharika Khanna, MD, MBBS, said she still wears one with her patients, and her office advises staff to do the same. If patients are experiencing respiratory symptoms, like a cough, they are asked to wear one. 

“When the patient first walks up to you, you have no idea what they have,” Dr. Khanna said. 

Dr. Khanna is especially mindful of immunocompromised patients who have cancer, and Dr. Ransone cares for several patients who have received kidney transplants and are on potent immunosuppressive drugs. 

“I know they’re appreciating our efforts to protect them, and I think the other patients are realizing that it’s a wise thing to do,” Dr. Ransone said. 

Some patients have anxiety about the end of masking in doctor offices, but others have been excited about interacting more with their care teams, according to William Dahut, MD, chief scientific officer for the American Cancer Society. Many clinicians will advise their most immunocompromised patients the same as they did prior to the COVID-19 pandemic. 

“There’s always been guidelines that oncologists have given to patients who are immunocompromised – we always told them to avoid crowded places, crowded scenes, be outside more than inside,” Dr. Dahut said. “Those general recommendations will continue.”

The AAFP supports masking to limit COVID’s spread, but the “most important thing people can do is to get vaccinated,” Tochi Iroku-Malize, MD, MPH, MBA, president of the AAFP, said.

But the accessibility of vaccinations is also shifting.
 

 

 

Testing shifts

The government will continue to provide free COVID-19 vaccines because it still has supplies on hand. When this stock runs out, commercial insurance providers will be required to cover the immunizations, as they are considered preventive, but people without insurance will have to pay out of pocket. 

The AAFP is pushing the Biden administration and Congress to keep the purchase price of those vaccines low enough that clinicians can keep them in stock, according to Dr. Iroku-Malize. Once the federal government transitions COVID-19 vaccines to the commercial market – as early as later in 2023 – it may pose some challenges for providers. 

“If the price of the vaccines is too high, physician practices may struggle to make the upfront investment in COVID-19 vaccines,” Dr. Iroku-Malize said. “Patients often prefer to receive vaccine counseling and administration from their usual source of primary care, like their family physician.” 

The federal government has also said it still has a supply of treatments for the public to access for free, but has not revealed how much it has on hand or given a timeline for the transition to the private market. 

COVID-19 tests, meanwhile, are no longer covered because of the end of the public health emergency, and cost about $45 per kit on average, according to an analysis by the Kaiser Family Foundation.

Pediatrician Lisa Costello, MD, MPH, knows that price point will be a challenge for some families she cares for at West Virginia University Medicine Children’s Hospital in Morgantown. Many still ask her where they can access free tests. 

“Testing if you’re a higher risk person is something we need to ensure that people continue to be educated about,” Dr. Costello said. 

She’s hopeful that COVID-19 vaccines and treatments such as Paxlovid will stay free in the coming months so patients can continue to easily access them.
 

Future of telehealth

Relaxed regulations of prescribing controlled substances via telehealth and across state lines allowed clinicians to treat patients near and far during the pandemic. But many providers were worried about a proposal from the Drug Enforcement Administration to clamp down on the prescribing of controlled substances via telehealth, according to A. Mark Fendrick, MD, an internal medicine physician at the University of Michigan, Ann Arbor.

“We were all panicking about what was going to happen to what is for many clinicians a very valuable policy,” Dr. Fendrick said of the telehealth flexibilities introduced during COVID-19. 

The DEA, after getting 38,000 comments on their proposed regulations, pulled back on that plan, delaying the cliff until November. 

Dr. Fendrick said that telehealth has allowed clinicians to reach patients who have historically faced barriers to care, such as lacking transportation. 

“The benefits of that outweigh the potential harms,” he said. “Every policy you make that tightens access because you want to decrease the untoward and unfortunate outcomes will also decrease access to clinical indications.”

The AAFP said it hopes for clear guidance from the DEA in the coming months on what the new telehealth landscape for prescribing will look like.
 

 

 

Medicaid changes

About half of the patients who see Dr. Khanna have insurance through Medicaid. 

During the public health emergency, states were not allowed to remove anyone from Medicaid, regardless of whether they no longer qualified for the program or not. But a law passed by Congress last year requires states to once again check Medicaid eligibility. As many as 15 million people could lose their Medicaid coverage

That could affect the treatments Dr. Khanna recommends for her patients who get kicked off because those who become uninsured or transition to private insurance will have to pay more out of pocket. Maryland will start removals in June. 

“When you have an uninsured patient versus Medicaid, it’s a huge difference in what you can ask the patient to do – the medications you can provide, the testing you can provide,” Dr. Khanna said. 

States were authorized to remove people from Medicaid as of April 1, with Arkansas, New Hampshire, and South Dakota starting right away. But many states are just now getting the review process going. About a dozen states, including Indiana, Ohio, Utah, and West Virginia, started removing people in May 2023. 

Uninsurance rates hit record lows across the United States during the pandemic. Keeping Americans on health insurance is a top priority for the AAFP, Dr. Iroku-Malize said. “We know health care coverage disruptions prevent people from seeking and accessing the care they need.”

Many people who are removed from Medicaid will be eligible for health insurance through employers, or through the Affordable Care Act’s private marketplace. But premiums and deductibles are often higher in these plans, which studies have shown result in patients delaying medical visits and not filling prescriptions or receiving treatment.
 

Staying mindful

Hospitals that receive federal funds will still have to report COVID-19 test results to the Centers for Medicare & Medicaid Services through 2024, although private labs will no longer be obligated to do so. The Centers for Disease Control and Prevention will also continue to monitor virus levels in communities through wastewater. But some states will no longer collect data. 

Gone are the days when clinicians and others would watch for daily totals of case counts with the type of fervor typically reserved for live scoring updates during sports games, according to Dr. Costello.

“We just have to be mindful of the numbers that might be coming in,” Dr. Costello said.

Dr. Ransone, however, cautioned that clinicians not become complacent. In early May, Dr. Ransone saw two patients with conjunctivitis, what patients thought was simply pink eye – a symptom of the latest COVID-19 variant. Both patients told him it wasn’t possible they had COVID-19 because they didn’t have coughs. 

“I don’t want to see physician offices fall into that trap that it’s over and be a potential nidus for infection for other patients,” Dr. Ransone said. “It’s incumbent upon us to remind people of the current symptoms so that folks will know when they need to wear a mask when they’re around their grandmother.”

The move away from universal masking in the office has benefits. Many of his older patients have difficulty hearing and had used lip reading to help understand him, he said. During the pandemic, masks got in the way of that form of communication. Now they can see his mouth again and better decipher what he says.

“Being able to have that face-to-face contact, without a mask intervening, has been really beneficial for a lot of my older patients,” he said.

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

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The first day of seeing patients without a mask was, for Sterling Ransone Jr., MD, “unsettling.” 

“I can’t tell you how weird it was the first day that I walked down the hall from my office to where my exam rooms are, to not have a mask on after 3 years of the habit,” said Dr. Ransone, a family physician in Deltaville, Va., and board chair of the American Academy of Family Physicians. 

The White House recently lifted the public health emergency order that overhauled the way health care providers operated and advised patients over the past 3 years. The new postpandemic era will require clinicians and staff to once again adjust. 

For Dr. Ransone, this transition entails getting used to his bare face, reminding patients of the latest and varying symptoms of the virus, and parting ways with sick patients if they refuse to wear a mask.

As states, hospitals, and health care systems around the country relax their mask mandates for care providers, clinicians will have to fall back on their own policies that patients with potential symptoms mask up. 

“Now that it’s up to our offices, we have to have a little bit more backbone,” Dr. Ransone said. “If they’re not willing to follow a health-related policy that will protect the vulnerable, we will not see them. And so for us, it’s been pretty straightforward.”

Despite the policy, Dr. Ransone has cared for patients who don’t disclose they are feeling sick until he enters the room. 

“And I wasn’t masked,” Dr. Ransone said. So, “I will wear masks for the rest of the day just to try to protect the rest of my patients in case I was exposed.”

Masks are optional for both patients and staff at the University of Maryland Medical System, but Niharika Khanna, MD, MBBS, said she still wears one with her patients, and her office advises staff to do the same. If patients are experiencing respiratory symptoms, like a cough, they are asked to wear one. 

“When the patient first walks up to you, you have no idea what they have,” Dr. Khanna said. 

Dr. Khanna is especially mindful of immunocompromised patients who have cancer, and Dr. Ransone cares for several patients who have received kidney transplants and are on potent immunosuppressive drugs. 

“I know they’re appreciating our efforts to protect them, and I think the other patients are realizing that it’s a wise thing to do,” Dr. Ransone said. 

Some patients have anxiety about the end of masking in doctor offices, but others have been excited about interacting more with their care teams, according to William Dahut, MD, chief scientific officer for the American Cancer Society. Many clinicians will advise their most immunocompromised patients the same as they did prior to the COVID-19 pandemic. 

“There’s always been guidelines that oncologists have given to patients who are immunocompromised – we always told them to avoid crowded places, crowded scenes, be outside more than inside,” Dr. Dahut said. “Those general recommendations will continue.”

The AAFP supports masking to limit COVID’s spread, but the “most important thing people can do is to get vaccinated,” Tochi Iroku-Malize, MD, MPH, MBA, president of the AAFP, said.

But the accessibility of vaccinations is also shifting.
 

 

 

Testing shifts

The government will continue to provide free COVID-19 vaccines because it still has supplies on hand. When this stock runs out, commercial insurance providers will be required to cover the immunizations, as they are considered preventive, but people without insurance will have to pay out of pocket. 

The AAFP is pushing the Biden administration and Congress to keep the purchase price of those vaccines low enough that clinicians can keep them in stock, according to Dr. Iroku-Malize. Once the federal government transitions COVID-19 vaccines to the commercial market – as early as later in 2023 – it may pose some challenges for providers. 

“If the price of the vaccines is too high, physician practices may struggle to make the upfront investment in COVID-19 vaccines,” Dr. Iroku-Malize said. “Patients often prefer to receive vaccine counseling and administration from their usual source of primary care, like their family physician.” 

The federal government has also said it still has a supply of treatments for the public to access for free, but has not revealed how much it has on hand or given a timeline for the transition to the private market. 

COVID-19 tests, meanwhile, are no longer covered because of the end of the public health emergency, and cost about $45 per kit on average, according to an analysis by the Kaiser Family Foundation.

Pediatrician Lisa Costello, MD, MPH, knows that price point will be a challenge for some families she cares for at West Virginia University Medicine Children’s Hospital in Morgantown. Many still ask her where they can access free tests. 

“Testing if you’re a higher risk person is something we need to ensure that people continue to be educated about,” Dr. Costello said. 

She’s hopeful that COVID-19 vaccines and treatments such as Paxlovid will stay free in the coming months so patients can continue to easily access them.
 

Future of telehealth

Relaxed regulations of prescribing controlled substances via telehealth and across state lines allowed clinicians to treat patients near and far during the pandemic. But many providers were worried about a proposal from the Drug Enforcement Administration to clamp down on the prescribing of controlled substances via telehealth, according to A. Mark Fendrick, MD, an internal medicine physician at the University of Michigan, Ann Arbor.

“We were all panicking about what was going to happen to what is for many clinicians a very valuable policy,” Dr. Fendrick said of the telehealth flexibilities introduced during COVID-19. 

The DEA, after getting 38,000 comments on their proposed regulations, pulled back on that plan, delaying the cliff until November. 

Dr. Fendrick said that telehealth has allowed clinicians to reach patients who have historically faced barriers to care, such as lacking transportation. 

“The benefits of that outweigh the potential harms,” he said. “Every policy you make that tightens access because you want to decrease the untoward and unfortunate outcomes will also decrease access to clinical indications.”

The AAFP said it hopes for clear guidance from the DEA in the coming months on what the new telehealth landscape for prescribing will look like.
 

 

 

Medicaid changes

About half of the patients who see Dr. Khanna have insurance through Medicaid. 

During the public health emergency, states were not allowed to remove anyone from Medicaid, regardless of whether they no longer qualified for the program or not. But a law passed by Congress last year requires states to once again check Medicaid eligibility. As many as 15 million people could lose their Medicaid coverage

That could affect the treatments Dr. Khanna recommends for her patients who get kicked off because those who become uninsured or transition to private insurance will have to pay more out of pocket. Maryland will start removals in June. 

“When you have an uninsured patient versus Medicaid, it’s a huge difference in what you can ask the patient to do – the medications you can provide, the testing you can provide,” Dr. Khanna said. 

States were authorized to remove people from Medicaid as of April 1, with Arkansas, New Hampshire, and South Dakota starting right away. But many states are just now getting the review process going. About a dozen states, including Indiana, Ohio, Utah, and West Virginia, started removing people in May 2023. 

Uninsurance rates hit record lows across the United States during the pandemic. Keeping Americans on health insurance is a top priority for the AAFP, Dr. Iroku-Malize said. “We know health care coverage disruptions prevent people from seeking and accessing the care they need.”

Many people who are removed from Medicaid will be eligible for health insurance through employers, or through the Affordable Care Act’s private marketplace. But premiums and deductibles are often higher in these plans, which studies have shown result in patients delaying medical visits and not filling prescriptions or receiving treatment.
 

Staying mindful

Hospitals that receive federal funds will still have to report COVID-19 test results to the Centers for Medicare & Medicaid Services through 2024, although private labs will no longer be obligated to do so. The Centers for Disease Control and Prevention will also continue to monitor virus levels in communities through wastewater. But some states will no longer collect data. 

Gone are the days when clinicians and others would watch for daily totals of case counts with the type of fervor typically reserved for live scoring updates during sports games, according to Dr. Costello.

“We just have to be mindful of the numbers that might be coming in,” Dr. Costello said.

Dr. Ransone, however, cautioned that clinicians not become complacent. In early May, Dr. Ransone saw two patients with conjunctivitis, what patients thought was simply pink eye – a symptom of the latest COVID-19 variant. Both patients told him it wasn’t possible they had COVID-19 because they didn’t have coughs. 

“I don’t want to see physician offices fall into that trap that it’s over and be a potential nidus for infection for other patients,” Dr. Ransone said. “It’s incumbent upon us to remind people of the current symptoms so that folks will know when they need to wear a mask when they’re around their grandmother.”

The move away from universal masking in the office has benefits. Many of his older patients have difficulty hearing and had used lip reading to help understand him, he said. During the pandemic, masks got in the way of that form of communication. Now they can see his mouth again and better decipher what he says.

“Being able to have that face-to-face contact, without a mask intervening, has been really beneficial for a lot of my older patients,” he said.

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

The first day of seeing patients without a mask was, for Sterling Ransone Jr., MD, “unsettling.” 

“I can’t tell you how weird it was the first day that I walked down the hall from my office to where my exam rooms are, to not have a mask on after 3 years of the habit,” said Dr. Ransone, a family physician in Deltaville, Va., and board chair of the American Academy of Family Physicians. 

The White House recently lifted the public health emergency order that overhauled the way health care providers operated and advised patients over the past 3 years. The new postpandemic era will require clinicians and staff to once again adjust. 

For Dr. Ransone, this transition entails getting used to his bare face, reminding patients of the latest and varying symptoms of the virus, and parting ways with sick patients if they refuse to wear a mask.

As states, hospitals, and health care systems around the country relax their mask mandates for care providers, clinicians will have to fall back on their own policies that patients with potential symptoms mask up. 

“Now that it’s up to our offices, we have to have a little bit more backbone,” Dr. Ransone said. “If they’re not willing to follow a health-related policy that will protect the vulnerable, we will not see them. And so for us, it’s been pretty straightforward.”

Despite the policy, Dr. Ransone has cared for patients who don’t disclose they are feeling sick until he enters the room. 

“And I wasn’t masked,” Dr. Ransone said. So, “I will wear masks for the rest of the day just to try to protect the rest of my patients in case I was exposed.”

Masks are optional for both patients and staff at the University of Maryland Medical System, but Niharika Khanna, MD, MBBS, said she still wears one with her patients, and her office advises staff to do the same. If patients are experiencing respiratory symptoms, like a cough, they are asked to wear one. 

“When the patient first walks up to you, you have no idea what they have,” Dr. Khanna said. 

Dr. Khanna is especially mindful of immunocompromised patients who have cancer, and Dr. Ransone cares for several patients who have received kidney transplants and are on potent immunosuppressive drugs. 

“I know they’re appreciating our efforts to protect them, and I think the other patients are realizing that it’s a wise thing to do,” Dr. Ransone said. 

Some patients have anxiety about the end of masking in doctor offices, but others have been excited about interacting more with their care teams, according to William Dahut, MD, chief scientific officer for the American Cancer Society. Many clinicians will advise their most immunocompromised patients the same as they did prior to the COVID-19 pandemic. 

“There’s always been guidelines that oncologists have given to patients who are immunocompromised – we always told them to avoid crowded places, crowded scenes, be outside more than inside,” Dr. Dahut said. “Those general recommendations will continue.”

The AAFP supports masking to limit COVID’s spread, but the “most important thing people can do is to get vaccinated,” Tochi Iroku-Malize, MD, MPH, MBA, president of the AAFP, said.

But the accessibility of vaccinations is also shifting.
 

 

 

Testing shifts

The government will continue to provide free COVID-19 vaccines because it still has supplies on hand. When this stock runs out, commercial insurance providers will be required to cover the immunizations, as they are considered preventive, but people without insurance will have to pay out of pocket. 

The AAFP is pushing the Biden administration and Congress to keep the purchase price of those vaccines low enough that clinicians can keep them in stock, according to Dr. Iroku-Malize. Once the federal government transitions COVID-19 vaccines to the commercial market – as early as later in 2023 – it may pose some challenges for providers. 

“If the price of the vaccines is too high, physician practices may struggle to make the upfront investment in COVID-19 vaccines,” Dr. Iroku-Malize said. “Patients often prefer to receive vaccine counseling and administration from their usual source of primary care, like their family physician.” 

The federal government has also said it still has a supply of treatments for the public to access for free, but has not revealed how much it has on hand or given a timeline for the transition to the private market. 

COVID-19 tests, meanwhile, are no longer covered because of the end of the public health emergency, and cost about $45 per kit on average, according to an analysis by the Kaiser Family Foundation.

Pediatrician Lisa Costello, MD, MPH, knows that price point will be a challenge for some families she cares for at West Virginia University Medicine Children’s Hospital in Morgantown. Many still ask her where they can access free tests. 

“Testing if you’re a higher risk person is something we need to ensure that people continue to be educated about,” Dr. Costello said. 

She’s hopeful that COVID-19 vaccines and treatments such as Paxlovid will stay free in the coming months so patients can continue to easily access them.
 

Future of telehealth

Relaxed regulations of prescribing controlled substances via telehealth and across state lines allowed clinicians to treat patients near and far during the pandemic. But many providers were worried about a proposal from the Drug Enforcement Administration to clamp down on the prescribing of controlled substances via telehealth, according to A. Mark Fendrick, MD, an internal medicine physician at the University of Michigan, Ann Arbor.

“We were all panicking about what was going to happen to what is for many clinicians a very valuable policy,” Dr. Fendrick said of the telehealth flexibilities introduced during COVID-19. 

The DEA, after getting 38,000 comments on their proposed regulations, pulled back on that plan, delaying the cliff until November. 

Dr. Fendrick said that telehealth has allowed clinicians to reach patients who have historically faced barriers to care, such as lacking transportation. 

“The benefits of that outweigh the potential harms,” he said. “Every policy you make that tightens access because you want to decrease the untoward and unfortunate outcomes will also decrease access to clinical indications.”

The AAFP said it hopes for clear guidance from the DEA in the coming months on what the new telehealth landscape for prescribing will look like.
 

 

 

Medicaid changes

About half of the patients who see Dr. Khanna have insurance through Medicaid. 

During the public health emergency, states were not allowed to remove anyone from Medicaid, regardless of whether they no longer qualified for the program or not. But a law passed by Congress last year requires states to once again check Medicaid eligibility. As many as 15 million people could lose their Medicaid coverage

That could affect the treatments Dr. Khanna recommends for her patients who get kicked off because those who become uninsured or transition to private insurance will have to pay more out of pocket. Maryland will start removals in June. 

“When you have an uninsured patient versus Medicaid, it’s a huge difference in what you can ask the patient to do – the medications you can provide, the testing you can provide,” Dr. Khanna said. 

States were authorized to remove people from Medicaid as of April 1, with Arkansas, New Hampshire, and South Dakota starting right away. But many states are just now getting the review process going. About a dozen states, including Indiana, Ohio, Utah, and West Virginia, started removing people in May 2023. 

Uninsurance rates hit record lows across the United States during the pandemic. Keeping Americans on health insurance is a top priority for the AAFP, Dr. Iroku-Malize said. “We know health care coverage disruptions prevent people from seeking and accessing the care they need.”

Many people who are removed from Medicaid will be eligible for health insurance through employers, or through the Affordable Care Act’s private marketplace. But premiums and deductibles are often higher in these plans, which studies have shown result in patients delaying medical visits and not filling prescriptions or receiving treatment.
 

Staying mindful

Hospitals that receive federal funds will still have to report COVID-19 test results to the Centers for Medicare & Medicaid Services through 2024, although private labs will no longer be obligated to do so. The Centers for Disease Control and Prevention will also continue to monitor virus levels in communities through wastewater. But some states will no longer collect data. 

Gone are the days when clinicians and others would watch for daily totals of case counts with the type of fervor typically reserved for live scoring updates during sports games, according to Dr. Costello.

“We just have to be mindful of the numbers that might be coming in,” Dr. Costello said.

Dr. Ransone, however, cautioned that clinicians not become complacent. In early May, Dr. Ransone saw two patients with conjunctivitis, what patients thought was simply pink eye – a symptom of the latest COVID-19 variant. Both patients told him it wasn’t possible they had COVID-19 because they didn’t have coughs. 

“I don’t want to see physician offices fall into that trap that it’s over and be a potential nidus for infection for other patients,” Dr. Ransone said. “It’s incumbent upon us to remind people of the current symptoms so that folks will know when they need to wear a mask when they’re around their grandmother.”

The move away from universal masking in the office has benefits. Many of his older patients have difficulty hearing and had used lip reading to help understand him, he said. During the pandemic, masks got in the way of that form of communication. Now they can see his mouth again and better decipher what he says.

“Being able to have that face-to-face contact, without a mask intervening, has been really beneficial for a lot of my older patients,” he said.

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

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U.S. adults report depression at record rates: Survey

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Depression rates among U.S. adults have reached the highest levels ever recorded since the national public opinion firm Gallup started tracking the mental illness in 2015.
 

In a survey, 29% of adults said they had been diagnosed with depression during their lifetime, and 18% said they currently have depression or are being treated for it. Those rates are up from the baseline 2015 rates of 20% of people ever having depression and 11% of people with a current diagnosis.

Depression had been steadily rising before the pandemic, and the Gallup analysts wrote that “social isolation, loneliness, fear of infection, psychological exhaustion (particularly among frontline responders such as health care workers), elevated substance abuse, and disruptions in mental health services have all likely played a role” in the increase.

“The fact that Americans are more depressed and struggling after this time of incredible stress and isolation is perhaps not surprising,” American Psychiatric Association president Rebecca Brendel, MD, told CNN. “There are lingering effects on our health, especially our mental health, from the past 3 years that disrupted everything we knew.”

The new estimates are based on online survey responses collected in February from 5,167 adults in the United States who answered the questions:

  • Has a doctor or nurse ever told you that you have depression?
  • Do you currently have or are you currently being treated for depression?

Depression, which is also called major depressive disorder, is a treatable illness that negatively affects how someone feels, thinks, and acts. The symptoms can be both emotional (such as sadness or loss of interest in activities) and physical (such as fatigue or slowed movements or speech).

The latest study found that depression rates increased the most among women, young adults, Black people, and Hispanic people. For the first time, more Black and Hispanic people than White people reported ever being diagnosed with depression. The lifetime depression rate among Black people was 34%, compared with 31% for Hispanic people and 29% for White people.

The rate of lifetime depression among women jumped 10 percentage points in the past 5 years, to 37%, in February, the survey results showed. About 1 in 4 women said they currently had depression or were being treated for it, up 6 percentage points compared with 5 years ago.

When responses were analyzed by age, those 18-44 years old were the most likely to report ever being diagnosed with depression or currently having the illness. About one-third of younger adults have ever been diagnosed, and more than 1 in 5 said they currently have depression.

Dr. Brendel said awareness and reduced stigma could be adding to the rising rates of depression.

“We’re making it easier to talk about mental health and looking at it as part of our overall wellness, just like physical health,” she said. “People are aware of depression, and people are seeking help for it.”

If you or someone you know needs help, dial 988 for support from the national Suicide & Crisis Lifeline. It’s free, confidential, and available 24 hours a day, 7 days a week. You can also visit 988lifeline.org and choose the chat feature.

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

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Depression rates among U.S. adults have reached the highest levels ever recorded since the national public opinion firm Gallup started tracking the mental illness in 2015.
 

In a survey, 29% of adults said they had been diagnosed with depression during their lifetime, and 18% said they currently have depression or are being treated for it. Those rates are up from the baseline 2015 rates of 20% of people ever having depression and 11% of people with a current diagnosis.

Depression had been steadily rising before the pandemic, and the Gallup analysts wrote that “social isolation, loneliness, fear of infection, psychological exhaustion (particularly among frontline responders such as health care workers), elevated substance abuse, and disruptions in mental health services have all likely played a role” in the increase.

“The fact that Americans are more depressed and struggling after this time of incredible stress and isolation is perhaps not surprising,” American Psychiatric Association president Rebecca Brendel, MD, told CNN. “There are lingering effects on our health, especially our mental health, from the past 3 years that disrupted everything we knew.”

The new estimates are based on online survey responses collected in February from 5,167 adults in the United States who answered the questions:

  • Has a doctor or nurse ever told you that you have depression?
  • Do you currently have or are you currently being treated for depression?

Depression, which is also called major depressive disorder, is a treatable illness that negatively affects how someone feels, thinks, and acts. The symptoms can be both emotional (such as sadness or loss of interest in activities) and physical (such as fatigue or slowed movements or speech).

The latest study found that depression rates increased the most among women, young adults, Black people, and Hispanic people. For the first time, more Black and Hispanic people than White people reported ever being diagnosed with depression. The lifetime depression rate among Black people was 34%, compared with 31% for Hispanic people and 29% for White people.

The rate of lifetime depression among women jumped 10 percentage points in the past 5 years, to 37%, in February, the survey results showed. About 1 in 4 women said they currently had depression or were being treated for it, up 6 percentage points compared with 5 years ago.

When responses were analyzed by age, those 18-44 years old were the most likely to report ever being diagnosed with depression or currently having the illness. About one-third of younger adults have ever been diagnosed, and more than 1 in 5 said they currently have depression.

Dr. Brendel said awareness and reduced stigma could be adding to the rising rates of depression.

“We’re making it easier to talk about mental health and looking at it as part of our overall wellness, just like physical health,” she said. “People are aware of depression, and people are seeking help for it.”

If you or someone you know needs help, dial 988 for support from the national Suicide & Crisis Lifeline. It’s free, confidential, and available 24 hours a day, 7 days a week. You can also visit 988lifeline.org and choose the chat feature.

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

Depression rates among U.S. adults have reached the highest levels ever recorded since the national public opinion firm Gallup started tracking the mental illness in 2015.
 

In a survey, 29% of adults said they had been diagnosed with depression during their lifetime, and 18% said they currently have depression or are being treated for it. Those rates are up from the baseline 2015 rates of 20% of people ever having depression and 11% of people with a current diagnosis.

Depression had been steadily rising before the pandemic, and the Gallup analysts wrote that “social isolation, loneliness, fear of infection, psychological exhaustion (particularly among frontline responders such as health care workers), elevated substance abuse, and disruptions in mental health services have all likely played a role” in the increase.

“The fact that Americans are more depressed and struggling after this time of incredible stress and isolation is perhaps not surprising,” American Psychiatric Association president Rebecca Brendel, MD, told CNN. “There are lingering effects on our health, especially our mental health, from the past 3 years that disrupted everything we knew.”

The new estimates are based on online survey responses collected in February from 5,167 adults in the United States who answered the questions:

  • Has a doctor or nurse ever told you that you have depression?
  • Do you currently have or are you currently being treated for depression?

Depression, which is also called major depressive disorder, is a treatable illness that negatively affects how someone feels, thinks, and acts. The symptoms can be both emotional (such as sadness or loss of interest in activities) and physical (such as fatigue or slowed movements or speech).

The latest study found that depression rates increased the most among women, young adults, Black people, and Hispanic people. For the first time, more Black and Hispanic people than White people reported ever being diagnosed with depression. The lifetime depression rate among Black people was 34%, compared with 31% for Hispanic people and 29% for White people.

The rate of lifetime depression among women jumped 10 percentage points in the past 5 years, to 37%, in February, the survey results showed. About 1 in 4 women said they currently had depression or were being treated for it, up 6 percentage points compared with 5 years ago.

When responses were analyzed by age, those 18-44 years old were the most likely to report ever being diagnosed with depression or currently having the illness. About one-third of younger adults have ever been diagnosed, and more than 1 in 5 said they currently have depression.

Dr. Brendel said awareness and reduced stigma could be adding to the rising rates of depression.

“We’re making it easier to talk about mental health and looking at it as part of our overall wellness, just like physical health,” she said. “People are aware of depression, and people are seeking help for it.”

If you or someone you know needs help, dial 988 for support from the national Suicide & Crisis Lifeline. It’s free, confidential, and available 24 hours a day, 7 days a week. You can also visit 988lifeline.org and choose the chat feature.

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

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The antimicrobial peptide that even Pharma can love

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Fastest peptide north, south, east, aaaaand west of the Pecos

Bacterial infections are supposed to be simple. You get infected, you get an antibiotic to treat it. Easy. Some bacteria, though, don’t play by the rules. Those antibiotics may kill 99.9% of germs, but what about the 0.1% that gets left behind? With their fallen comrades out of the way, the accidentally drug resistant species are free to inherit the Earth.

Antibiotic resistance is thus a major concern for the medical community. Naturally, anything that prevents doctors from successfully curing sick people is a priority. Unless you’re a major pharmaceutical company that has been loath to develop new drugs that can beat antibiotic-resistant bacteria. Blah blah, time and money, blah blah, long time between development and market application, blah blah, no profit. We all know the story with pharmaceutical companies.

Ilana Camargo

Research from other sources has continued, however, and Brazilian scientists recently published research involving a peptide known as plantaricin 149. This peptide, derived from the bacterium Lactobacillus plantarum, has been known for nearly 30 years to have antibacterial properties. Pln149 in its natural state, though, is not particularly efficient at bacteria-killing. Fortunately, we have science and technology on our side.

The researchers synthesized 20 analogs of Pln149, of which Pln149-PEP20 had the best results. The elegantly named compound is less than half the size of the original peptide, less toxic, and far better at killing any and all drug-resistant bacteria the researchers threw at it. How much better? Pln149-PEP20 started killing bacteria less than an hour after being introduced in lab trials.

The research is just in its early days – just because something is less toxic doesn’t necessarily mean you want to go and help yourself to it – but we can only hope that those lovely pharmaceutical companies deign to look down upon us and actually develop a drug utilizing Pln149-PEP20 to, you know, actually help sick people, instead of trying to build monopolies or avoiding paying billions in taxes. Yeah, we couldn’t keep a straight face through that last sentence either.
 

Speed healing: The wavy wound gets the swirl

Did you know that wavy wounds heal faster than straight wounds? Well, we didn’t, but apparently quite a few people did, because somebody has been trying to figure out why wavy wounds heal faster than straight ones. Do the surgeons know about this? How about you dermatologists? Wavy over straight? We’re the media. We’re supposed to report this kind of stuff. Maybe hit us with a tweet next time you do something important, or push a TikTok our way, okay?

You could be more like the investigators at Nanyang Technological University in Singapore, who figured out the why and then released a statement about it.

NTU Singapore

They created synthetic wounds – some straight, some wavy – in micropatterned hydrogel substrates that mimicked human skin. Then they used an advanced optical technique known as particle image velocimetry to measure fluid flow and learn how cells moved to close the wound gaps.

The wavy wounds “induced more complex collective cell movements, such as a swirly, vortex-like motion,” according to the written statement from NTU Singapore. In the straight wounds, cell movements paralleled the wound front, “moving in straight lines like a marching band,” they pointed out, unlike some researchers who never call us unless they need money.

Complex epithelial cell movements are better, it turns out. Over an observation period of 64 hours the NTU team found that the healing efficiency of wavy gaps – measured by the area covered by the cells over time – is nearly five times faster than straight gaps.

The complex motion “enabled cells to quickly connect with similar cells on the opposite site of the wound edge, forming a bridge and closing the wavy wound gaps faster than straight gaps,” explained lead author Xu Hongmei, a doctoral student at NTU’s School of Mechanical and Aerospace Engineering, who seems to have time to toss out a tumblr or two to keep the press informed.

As for the rest of you, would it kill you to pick up a phone once in a while? Maybe let a journalist know that you’re still alive? We have feelings too, you know, and we worry.
 

 

 

A little Jekyll, a little Hyde, and a little shop of horrors

More “Little Shop of Horrors” references are coming, so be prepared.

We begin with Triphyophyllum peltatum. This woody vine is of great interest to medical and pharmaceutical researchers because its constituents have shown promise against pancreatic cancer and leukemia cells, among others, along with the pathogens that cause malaria and other diseases. There is another side, however. T. peltatum also has a tendency to turn into a realistic Audrey II when deprived.

No, of course they’re not craving human flesh, but it does become … carnivorous in its appetite.

T. peltatum, native to the West African tropics and not found in a New York florist shop, has the unique ability to change its diet and development based on the environmental circumstances. For some unknown reason, the leaves would develop adhesive traps in the form of sticky drops that capture insect prey. The plant is notoriously hard to grow, however, so no one could study the transformation under lab conditions. Until now.

Traud Winkelmann/University of Hannover

A group of German scientists “exposed the plant to different stress factors, including deficiencies of various nutrients, and studied how it responded to each,” said Dr. Traud Winkelmann of Leibniz University Hannover. “Only in one case were we able to observe the formation of traps: in the case of a lack of phosphorus.”

Well, there you have it: phosphorus. We need it for healthy bones and teeth, which this plant doesn’t have to worry about, unlike its Tony Award–nominated counterpart. The investigators hope that their findings could lead to “future molecular analyses that will help understand the origins of carnivory,” but we’re guessing that a certain singing alien species will be left out of that research.

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Fastest peptide north, south, east, aaaaand west of the Pecos

Bacterial infections are supposed to be simple. You get infected, you get an antibiotic to treat it. Easy. Some bacteria, though, don’t play by the rules. Those antibiotics may kill 99.9% of germs, but what about the 0.1% that gets left behind? With their fallen comrades out of the way, the accidentally drug resistant species are free to inherit the Earth.

Antibiotic resistance is thus a major concern for the medical community. Naturally, anything that prevents doctors from successfully curing sick people is a priority. Unless you’re a major pharmaceutical company that has been loath to develop new drugs that can beat antibiotic-resistant bacteria. Blah blah, time and money, blah blah, long time between development and market application, blah blah, no profit. We all know the story with pharmaceutical companies.

Ilana Camargo

Research from other sources has continued, however, and Brazilian scientists recently published research involving a peptide known as plantaricin 149. This peptide, derived from the bacterium Lactobacillus plantarum, has been known for nearly 30 years to have antibacterial properties. Pln149 in its natural state, though, is not particularly efficient at bacteria-killing. Fortunately, we have science and technology on our side.

The researchers synthesized 20 analogs of Pln149, of which Pln149-PEP20 had the best results. The elegantly named compound is less than half the size of the original peptide, less toxic, and far better at killing any and all drug-resistant bacteria the researchers threw at it. How much better? Pln149-PEP20 started killing bacteria less than an hour after being introduced in lab trials.

The research is just in its early days – just because something is less toxic doesn’t necessarily mean you want to go and help yourself to it – but we can only hope that those lovely pharmaceutical companies deign to look down upon us and actually develop a drug utilizing Pln149-PEP20 to, you know, actually help sick people, instead of trying to build monopolies or avoiding paying billions in taxes. Yeah, we couldn’t keep a straight face through that last sentence either.
 

Speed healing: The wavy wound gets the swirl

Did you know that wavy wounds heal faster than straight wounds? Well, we didn’t, but apparently quite a few people did, because somebody has been trying to figure out why wavy wounds heal faster than straight ones. Do the surgeons know about this? How about you dermatologists? Wavy over straight? We’re the media. We’re supposed to report this kind of stuff. Maybe hit us with a tweet next time you do something important, or push a TikTok our way, okay?

You could be more like the investigators at Nanyang Technological University in Singapore, who figured out the why and then released a statement about it.

NTU Singapore

They created synthetic wounds – some straight, some wavy – in micropatterned hydrogel substrates that mimicked human skin. Then they used an advanced optical technique known as particle image velocimetry to measure fluid flow and learn how cells moved to close the wound gaps.

The wavy wounds “induced more complex collective cell movements, such as a swirly, vortex-like motion,” according to the written statement from NTU Singapore. In the straight wounds, cell movements paralleled the wound front, “moving in straight lines like a marching band,” they pointed out, unlike some researchers who never call us unless they need money.

Complex epithelial cell movements are better, it turns out. Over an observation period of 64 hours the NTU team found that the healing efficiency of wavy gaps – measured by the area covered by the cells over time – is nearly five times faster than straight gaps.

The complex motion “enabled cells to quickly connect with similar cells on the opposite site of the wound edge, forming a bridge and closing the wavy wound gaps faster than straight gaps,” explained lead author Xu Hongmei, a doctoral student at NTU’s School of Mechanical and Aerospace Engineering, who seems to have time to toss out a tumblr or two to keep the press informed.

As for the rest of you, would it kill you to pick up a phone once in a while? Maybe let a journalist know that you’re still alive? We have feelings too, you know, and we worry.
 

 

 

A little Jekyll, a little Hyde, and a little shop of horrors

More “Little Shop of Horrors” references are coming, so be prepared.

We begin with Triphyophyllum peltatum. This woody vine is of great interest to medical and pharmaceutical researchers because its constituents have shown promise against pancreatic cancer and leukemia cells, among others, along with the pathogens that cause malaria and other diseases. There is another side, however. T. peltatum also has a tendency to turn into a realistic Audrey II when deprived.

No, of course they’re not craving human flesh, but it does become … carnivorous in its appetite.

T. peltatum, native to the West African tropics and not found in a New York florist shop, has the unique ability to change its diet and development based on the environmental circumstances. For some unknown reason, the leaves would develop adhesive traps in the form of sticky drops that capture insect prey. The plant is notoriously hard to grow, however, so no one could study the transformation under lab conditions. Until now.

Traud Winkelmann/University of Hannover

A group of German scientists “exposed the plant to different stress factors, including deficiencies of various nutrients, and studied how it responded to each,” said Dr. Traud Winkelmann of Leibniz University Hannover. “Only in one case were we able to observe the formation of traps: in the case of a lack of phosphorus.”

Well, there you have it: phosphorus. We need it for healthy bones and teeth, which this plant doesn’t have to worry about, unlike its Tony Award–nominated counterpart. The investigators hope that their findings could lead to “future molecular analyses that will help understand the origins of carnivory,” but we’re guessing that a certain singing alien species will be left out of that research.

 

Fastest peptide north, south, east, aaaaand west of the Pecos

Bacterial infections are supposed to be simple. You get infected, you get an antibiotic to treat it. Easy. Some bacteria, though, don’t play by the rules. Those antibiotics may kill 99.9% of germs, but what about the 0.1% that gets left behind? With their fallen comrades out of the way, the accidentally drug resistant species are free to inherit the Earth.

Antibiotic resistance is thus a major concern for the medical community. Naturally, anything that prevents doctors from successfully curing sick people is a priority. Unless you’re a major pharmaceutical company that has been loath to develop new drugs that can beat antibiotic-resistant bacteria. Blah blah, time and money, blah blah, long time between development and market application, blah blah, no profit. We all know the story with pharmaceutical companies.

Ilana Camargo

Research from other sources has continued, however, and Brazilian scientists recently published research involving a peptide known as plantaricin 149. This peptide, derived from the bacterium Lactobacillus plantarum, has been known for nearly 30 years to have antibacterial properties. Pln149 in its natural state, though, is not particularly efficient at bacteria-killing. Fortunately, we have science and technology on our side.

The researchers synthesized 20 analogs of Pln149, of which Pln149-PEP20 had the best results. The elegantly named compound is less than half the size of the original peptide, less toxic, and far better at killing any and all drug-resistant bacteria the researchers threw at it. How much better? Pln149-PEP20 started killing bacteria less than an hour after being introduced in lab trials.

The research is just in its early days – just because something is less toxic doesn’t necessarily mean you want to go and help yourself to it – but we can only hope that those lovely pharmaceutical companies deign to look down upon us and actually develop a drug utilizing Pln149-PEP20 to, you know, actually help sick people, instead of trying to build monopolies or avoiding paying billions in taxes. Yeah, we couldn’t keep a straight face through that last sentence either.
 

Speed healing: The wavy wound gets the swirl

Did you know that wavy wounds heal faster than straight wounds? Well, we didn’t, but apparently quite a few people did, because somebody has been trying to figure out why wavy wounds heal faster than straight ones. Do the surgeons know about this? How about you dermatologists? Wavy over straight? We’re the media. We’re supposed to report this kind of stuff. Maybe hit us with a tweet next time you do something important, or push a TikTok our way, okay?

You could be more like the investigators at Nanyang Technological University in Singapore, who figured out the why and then released a statement about it.

NTU Singapore

They created synthetic wounds – some straight, some wavy – in micropatterned hydrogel substrates that mimicked human skin. Then they used an advanced optical technique known as particle image velocimetry to measure fluid flow and learn how cells moved to close the wound gaps.

The wavy wounds “induced more complex collective cell movements, such as a swirly, vortex-like motion,” according to the written statement from NTU Singapore. In the straight wounds, cell movements paralleled the wound front, “moving in straight lines like a marching band,” they pointed out, unlike some researchers who never call us unless they need money.

Complex epithelial cell movements are better, it turns out. Over an observation period of 64 hours the NTU team found that the healing efficiency of wavy gaps – measured by the area covered by the cells over time – is nearly five times faster than straight gaps.

The complex motion “enabled cells to quickly connect with similar cells on the opposite site of the wound edge, forming a bridge and closing the wavy wound gaps faster than straight gaps,” explained lead author Xu Hongmei, a doctoral student at NTU’s School of Mechanical and Aerospace Engineering, who seems to have time to toss out a tumblr or two to keep the press informed.

As for the rest of you, would it kill you to pick up a phone once in a while? Maybe let a journalist know that you’re still alive? We have feelings too, you know, and we worry.
 

 

 

A little Jekyll, a little Hyde, and a little shop of horrors

More “Little Shop of Horrors” references are coming, so be prepared.

We begin with Triphyophyllum peltatum. This woody vine is of great interest to medical and pharmaceutical researchers because its constituents have shown promise against pancreatic cancer and leukemia cells, among others, along with the pathogens that cause malaria and other diseases. There is another side, however. T. peltatum also has a tendency to turn into a realistic Audrey II when deprived.

No, of course they’re not craving human flesh, but it does become … carnivorous in its appetite.

T. peltatum, native to the West African tropics and not found in a New York florist shop, has the unique ability to change its diet and development based on the environmental circumstances. For some unknown reason, the leaves would develop adhesive traps in the form of sticky drops that capture insect prey. The plant is notoriously hard to grow, however, so no one could study the transformation under lab conditions. Until now.

Traud Winkelmann/University of Hannover

A group of German scientists “exposed the plant to different stress factors, including deficiencies of various nutrients, and studied how it responded to each,” said Dr. Traud Winkelmann of Leibniz University Hannover. “Only in one case were we able to observe the formation of traps: in the case of a lack of phosphorus.”

Well, there you have it: phosphorus. We need it for healthy bones and teeth, which this plant doesn’t have to worry about, unlike its Tony Award–nominated counterpart. The investigators hope that their findings could lead to “future molecular analyses that will help understand the origins of carnivory,” but we’re guessing that a certain singing alien species will be left out of that research.

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PARP inhibitors and breast cancer: Questions remain about wider use

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While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

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While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

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FROM ESMO BREAST CANCER 2023

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Mailed HPV test kits boost cervical cancer screening

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Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. 

The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. 

The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.

In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”

The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years. 

Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.

The other third of women, the control group, only received scheduling assistance.

The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment. 

Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group. 

Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.

University of North Carolina
Dr. Jennifer Smith

About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.

“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”

“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said. 

University of North Carolina
Dr. Noel Brewer

“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”

Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.

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

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Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. 

The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. 

The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.

In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”

The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years. 

Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.

The other third of women, the control group, only received scheduling assistance.

The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment. 

Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group. 

Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.

University of North Carolina
Dr. Jennifer Smith

About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.

“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”

“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said. 

University of North Carolina
Dr. Noel Brewer

“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”

Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.

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

Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. 

The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. 

The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.

In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”

The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years. 

Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.

The other third of women, the control group, only received scheduling assistance.

The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment. 

Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group. 

Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.

University of North Carolina
Dr. Jennifer Smith

About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.

“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”

“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said. 

University of North Carolina
Dr. Noel Brewer

“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”

Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.

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

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Expunging ‘penicillin allergy’: Your questions answered

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Last month, I described a 28-year-old patient with a history of injection drug use who presented with pain in his left forearm. His history showed that, within the past 2 years, he’d been seen for cutaneous infections multiple times as an outpatient and in the emergency department. His records indicated that he was diagnosed with a penicillin allergy as a child when he developed a rash after receiving amoxicillin. I believed the next course of action should be to test for a penicillin allergy with an oral amoxicillin challenge.
 

Thank you for your excellent questions regarding this case. Great to hear the enthusiasm for testing for penicillin allergy!

One question focused on the course of action in the case of a mild or moderate IgE-mediated reaction after a single dose test with amoxicillin. Treatment for these reactions should include an antihistamine. I would reserve intravenous antihistamines for more severe cases, which also require treatment with a course of corticosteroids. However, the risk for a moderate to severe reaction to amoxicillin on retesting is quite low.

Clinicians need to exercise caution in the use of systemic corticosteroids. These drugs can be lifesaving, but even short courses of corticosteroids are associated with potentially serious adverse events. In a review of adverse events associated with short-course systemic corticosteroids among children, the rate of vomiting was 5.4%; behavioral change, 4.7%; and sleep disturbance, 4.3%. One child died after contracting herpes zoster, more than one-third of children developed elevated blood pressure, and 81.1% had evidence of suppression of the hypothalamic-pituitary-adrenal axis.

Among adults, short courses of systemic corticosteroids are associated with acute increases in the risks for gastrointestinal bleeding and hypertension. Cumulative exposure to short courses of corticosteroids over time results in higher risks for obesity, type 2 diabetes, and osteoporosis.

Another question prompted by this young man’s case focused on the durability of IgE reactions against penicillin. The IgE response to penicillin does indeed wane over time; 80% of patients with a previous true penicillin allergy can tolerate the antibiotic after 10 years. Thus, about 95% of patients with a remote history of penicillin allergy are tolerant of penicillin, and testing can be performed using the algorithm described.

Clinicians should avoid applying current guidelines for the evaluation of patients with penicillin allergy to other common drug allergies. The overall prevalence of sulfonamide allergy is 3%-8%, and the vast majority of these reactions follow treatment with trimethoprim-sulfamethoxazole. Sulfa allergy is even more common among persons living with HIV infection. The natural history of sulfa allergy is not as well established as penicillin allergy. Allergy testing is encouraged in these cases. Graded oral challenge testing is best reserved for patients who are unlikely to have a true sulfa allergy based on their history.

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

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Last month, I described a 28-year-old patient with a history of injection drug use who presented with pain in his left forearm. His history showed that, within the past 2 years, he’d been seen for cutaneous infections multiple times as an outpatient and in the emergency department. His records indicated that he was diagnosed with a penicillin allergy as a child when he developed a rash after receiving amoxicillin. I believed the next course of action should be to test for a penicillin allergy with an oral amoxicillin challenge.
 

Thank you for your excellent questions regarding this case. Great to hear the enthusiasm for testing for penicillin allergy!

One question focused on the course of action in the case of a mild or moderate IgE-mediated reaction after a single dose test with amoxicillin. Treatment for these reactions should include an antihistamine. I would reserve intravenous antihistamines for more severe cases, which also require treatment with a course of corticosteroids. However, the risk for a moderate to severe reaction to amoxicillin on retesting is quite low.

Clinicians need to exercise caution in the use of systemic corticosteroids. These drugs can be lifesaving, but even short courses of corticosteroids are associated with potentially serious adverse events. In a review of adverse events associated with short-course systemic corticosteroids among children, the rate of vomiting was 5.4%; behavioral change, 4.7%; and sleep disturbance, 4.3%. One child died after contracting herpes zoster, more than one-third of children developed elevated blood pressure, and 81.1% had evidence of suppression of the hypothalamic-pituitary-adrenal axis.

Among adults, short courses of systemic corticosteroids are associated with acute increases in the risks for gastrointestinal bleeding and hypertension. Cumulative exposure to short courses of corticosteroids over time results in higher risks for obesity, type 2 diabetes, and osteoporosis.

Another question prompted by this young man’s case focused on the durability of IgE reactions against penicillin. The IgE response to penicillin does indeed wane over time; 80% of patients with a previous true penicillin allergy can tolerate the antibiotic after 10 years. Thus, about 95% of patients with a remote history of penicillin allergy are tolerant of penicillin, and testing can be performed using the algorithm described.

Clinicians should avoid applying current guidelines for the evaluation of patients with penicillin allergy to other common drug allergies. The overall prevalence of sulfonamide allergy is 3%-8%, and the vast majority of these reactions follow treatment with trimethoprim-sulfamethoxazole. Sulfa allergy is even more common among persons living with HIV infection. The natural history of sulfa allergy is not as well established as penicillin allergy. Allergy testing is encouraged in these cases. Graded oral challenge testing is best reserved for patients who are unlikely to have a true sulfa allergy based on their history.

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

Last month, I described a 28-year-old patient with a history of injection drug use who presented with pain in his left forearm. His history showed that, within the past 2 years, he’d been seen for cutaneous infections multiple times as an outpatient and in the emergency department. His records indicated that he was diagnosed with a penicillin allergy as a child when he developed a rash after receiving amoxicillin. I believed the next course of action should be to test for a penicillin allergy with an oral amoxicillin challenge.
 

Thank you for your excellent questions regarding this case. Great to hear the enthusiasm for testing for penicillin allergy!

One question focused on the course of action in the case of a mild or moderate IgE-mediated reaction after a single dose test with amoxicillin. Treatment for these reactions should include an antihistamine. I would reserve intravenous antihistamines for more severe cases, which also require treatment with a course of corticosteroids. However, the risk for a moderate to severe reaction to amoxicillin on retesting is quite low.

Clinicians need to exercise caution in the use of systemic corticosteroids. These drugs can be lifesaving, but even short courses of corticosteroids are associated with potentially serious adverse events. In a review of adverse events associated with short-course systemic corticosteroids among children, the rate of vomiting was 5.4%; behavioral change, 4.7%; and sleep disturbance, 4.3%. One child died after contracting herpes zoster, more than one-third of children developed elevated blood pressure, and 81.1% had evidence of suppression of the hypothalamic-pituitary-adrenal axis.

Among adults, short courses of systemic corticosteroids are associated with acute increases in the risks for gastrointestinal bleeding and hypertension. Cumulative exposure to short courses of corticosteroids over time results in higher risks for obesity, type 2 diabetes, and osteoporosis.

Another question prompted by this young man’s case focused on the durability of IgE reactions against penicillin. The IgE response to penicillin does indeed wane over time; 80% of patients with a previous true penicillin allergy can tolerate the antibiotic after 10 years. Thus, about 95% of patients with a remote history of penicillin allergy are tolerant of penicillin, and testing can be performed using the algorithm described.

Clinicians should avoid applying current guidelines for the evaluation of patients with penicillin allergy to other common drug allergies. The overall prevalence of sulfonamide allergy is 3%-8%, and the vast majority of these reactions follow treatment with trimethoprim-sulfamethoxazole. Sulfa allergy is even more common among persons living with HIV infection. The natural history of sulfa allergy is not as well established as penicillin allergy. Allergy testing is encouraged in these cases. Graded oral challenge testing is best reserved for patients who are unlikely to have a true sulfa allergy based on their history.

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

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Investigational drug peresolimab shows efficacy in patients with RA

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The investigational drug peresolimab, a humanized monoclonal antibody that stimulates human programmed cell death protein 1 (PD-1), shows efficacy in treating rheumatoid arthritis (RA), according to results from a phase 2 clinical trial.

After 12 weeks, patients receiving peresolimab 700 mg saw a greater improvement in the primary endpoint of change in Disease Activity Score for 28 joints based on C-reactive protein (DAS28-CRP), compared with placebo.

“These results provide evidence that stimulation of the PD-1 receptor has potential efficacy in the treatment of rheumatoid arthritis,” said the authors, led by Jay Tuttle, PhD, of Eli Lilly and Company. The study was published in the New England Journal of Medicine.

A total of 98 patients with treatment-resistant, moderate to severe RA were enrolled in the double-blind, placebo-controlled trial. All patients had previously experienced treatment failure with biologic, targeted synthetic, or conventional synthetic disease-modifying antirheumatic drugs. Patients were randomized to receive 700 mg of peresolimab (49 patients), 300 mg of peresolimab (25 patients), or placebo (24 patients) intravenously once every 4 weeks.

Only patients taking peresolimab 700 mg had a significantly greater change in DAS28-CRP scores after 12 weeks, compared with placebo. In secondary outcomes, 71% of the 700-mg group experienced an improvement of at least 20% in American College of Rheumatology response criteria (ACR20), as compared with 42% in the placebo group. There was no difference between the placebo and peresolimab groups in ACR50 or ACR70 responses.

The safety profiles were similar across all three groups, although the 700-mg peresolimab group had numerically more adverse events (n = 14) than the 300-mg peresolimab group (n = 8) and the placebo group (n = 9). There were no severe adverse events reported during the study period. The authors noted that larger and longer studies are necessary to understand the safety of peresolimab.

“Careful evaluation of the effect of peresolimab on the risk of cancer will be important given the efficacy of PD-1 inhibitors in oncologic disease,” the authors wrote.

Eli Lilly funded the research. Researchers disclosed financial relationships with AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and several other pharmaceutical companies.

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The investigational drug peresolimab, a humanized monoclonal antibody that stimulates human programmed cell death protein 1 (PD-1), shows efficacy in treating rheumatoid arthritis (RA), according to results from a phase 2 clinical trial.

After 12 weeks, patients receiving peresolimab 700 mg saw a greater improvement in the primary endpoint of change in Disease Activity Score for 28 joints based on C-reactive protein (DAS28-CRP), compared with placebo.

“These results provide evidence that stimulation of the PD-1 receptor has potential efficacy in the treatment of rheumatoid arthritis,” said the authors, led by Jay Tuttle, PhD, of Eli Lilly and Company. The study was published in the New England Journal of Medicine.

A total of 98 patients with treatment-resistant, moderate to severe RA were enrolled in the double-blind, placebo-controlled trial. All patients had previously experienced treatment failure with biologic, targeted synthetic, or conventional synthetic disease-modifying antirheumatic drugs. Patients were randomized to receive 700 mg of peresolimab (49 patients), 300 mg of peresolimab (25 patients), or placebo (24 patients) intravenously once every 4 weeks.

Only patients taking peresolimab 700 mg had a significantly greater change in DAS28-CRP scores after 12 weeks, compared with placebo. In secondary outcomes, 71% of the 700-mg group experienced an improvement of at least 20% in American College of Rheumatology response criteria (ACR20), as compared with 42% in the placebo group. There was no difference between the placebo and peresolimab groups in ACR50 or ACR70 responses.

The safety profiles were similar across all three groups, although the 700-mg peresolimab group had numerically more adverse events (n = 14) than the 300-mg peresolimab group (n = 8) and the placebo group (n = 9). There were no severe adverse events reported during the study period. The authors noted that larger and longer studies are necessary to understand the safety of peresolimab.

“Careful evaluation of the effect of peresolimab on the risk of cancer will be important given the efficacy of PD-1 inhibitors in oncologic disease,” the authors wrote.

Eli Lilly funded the research. Researchers disclosed financial relationships with AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and several other pharmaceutical companies.

The investigational drug peresolimab, a humanized monoclonal antibody that stimulates human programmed cell death protein 1 (PD-1), shows efficacy in treating rheumatoid arthritis (RA), according to results from a phase 2 clinical trial.

After 12 weeks, patients receiving peresolimab 700 mg saw a greater improvement in the primary endpoint of change in Disease Activity Score for 28 joints based on C-reactive protein (DAS28-CRP), compared with placebo.

“These results provide evidence that stimulation of the PD-1 receptor has potential efficacy in the treatment of rheumatoid arthritis,” said the authors, led by Jay Tuttle, PhD, of Eli Lilly and Company. The study was published in the New England Journal of Medicine.

A total of 98 patients with treatment-resistant, moderate to severe RA were enrolled in the double-blind, placebo-controlled trial. All patients had previously experienced treatment failure with biologic, targeted synthetic, or conventional synthetic disease-modifying antirheumatic drugs. Patients were randomized to receive 700 mg of peresolimab (49 patients), 300 mg of peresolimab (25 patients), or placebo (24 patients) intravenously once every 4 weeks.

Only patients taking peresolimab 700 mg had a significantly greater change in DAS28-CRP scores after 12 weeks, compared with placebo. In secondary outcomes, 71% of the 700-mg group experienced an improvement of at least 20% in American College of Rheumatology response criteria (ACR20), as compared with 42% in the placebo group. There was no difference between the placebo and peresolimab groups in ACR50 or ACR70 responses.

The safety profiles were similar across all three groups, although the 700-mg peresolimab group had numerically more adverse events (n = 14) than the 300-mg peresolimab group (n = 8) and the placebo group (n = 9). There were no severe adverse events reported during the study period. The authors noted that larger and longer studies are necessary to understand the safety of peresolimab.

“Careful evaluation of the effect of peresolimab on the risk of cancer will be important given the efficacy of PD-1 inhibitors in oncologic disease,” the authors wrote.

Eli Lilly funded the research. Researchers disclosed financial relationships with AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and several other pharmaceutical companies.

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Study explains link between fatty liver and CRC liver metastasis

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Having a fatty liver raises a patient’s risk of colorectal cancer liver metastasis via an immunosuppressive tumor microenvironment, yes-associated protein (YAP) signaling, and extracellular vesicle-microRNAs, according to the authors of new research.

These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.

“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”

To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.

Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.

“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”

One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.

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Having a fatty liver raises a patient’s risk of colorectal cancer liver metastasis via an immunosuppressive tumor microenvironment, yes-associated protein (YAP) signaling, and extracellular vesicle-microRNAs, according to the authors of new research.

These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.

“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”

To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.

Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.

“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”

One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.

Having a fatty liver raises a patient’s risk of colorectal cancer liver metastasis via an immunosuppressive tumor microenvironment, yes-associated protein (YAP) signaling, and extracellular vesicle-microRNAs, according to the authors of new research.

These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.

“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”

To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.

Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.

“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”

One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.

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