A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.

A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.

A 2021 update to the U.S. Preventive Services Task Force lung cancer screening guidelines eliminated racial disparities that were prevalent in the group’s 2013 guidance, according to a report in JAMA Oncology.

Fewer Black people qualified for screening in the earlier guideline of which the majority of its participants were White. In response, the group changed the screening eligibility age from 55 to 50 years and lowered the smoking pack by year requirement from 30 to 20 years.

The changes showed that Black smokers tend to develop lung cancer earlier and with fewer pack-years than White smokers.
 

The study details

To gauge the impact, investigators from Wayne State University, Detroit, reviewed 912 patients with lung cancer and 1,457 controls without lung cancer to see who would have qualified for screening under the 2013 and 2021 criteria.

They were participants in the Detroit-area INHALE (Inflammation, Health, Ancestry, and Lung Epidemiology) study from 2012 to 2018. Over 30% were Black.

“Lowering the age and smoking criteria successfully bridged the gap in racial disparity,” said investigators led by Chan Yeu Pu, MD, a lung cancer specialist at Wayne State University.

With the 2021 criteria, 65% of White patients and 63% of Black patients with lung cancer would have been eligible for screening. Under the 2013 guidance, 52% of White patients were eligible for screening, but only 42% of Black patients.

The update also eliminated racial disparities among controls. The new guidance excluded 48% of White controls without lung cancer from screening and 50% of Black controls. The 2013 criteria excluded fewer White controls (61%) than Black control subjects (70%).

“As expected, broader inclusion criteria increased sensitivity, but at the cost of decreased specificity,” the investigators wrote.
 

Why is screening important?

The hope of screening is to catch lung cancer early, when curative surgical resection is still possible, the team wrote, but although screening has increased over the years, uptake remains dismal, just 5% in 2018, for instance.

In an editorial, Philadelphia-area thoracic surgeons Jonathan Nitz, MD, and Cherie Erkmen, MD, wrote that “multiple and changing criteria” and “nebulous payment plans” have made “for a confusing message. ... We need standardized” guidelines to deliver “a clear message about lung cancer screening.”

The fact that nearly two-thirds of lung cancer patients wouldn’t have qualified for screening under current guidelines also needs to be addressed. “We need standardized practice guidelines based on evidence from diverse populations and policies to ensure equitable access for high-risk individuals. Although this study demonstrates improved, calculated sensitivity of the 2021 USPSTF guidelines to detect lung cancer, these refinements of criteria do not address the nearly two-thirds of patients with diagnosed lung cancer who are not eligible for screening. There is a pressing need to redefine screening criteria,” Dr. Nitz and Dr. Erkmen wrote.

Both the 2013 and 2021 guidelines were outperformed in the study by the 2012 modification of the model from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCOm2012 criteria), but only marginally so in the case of USPSTF’s 2021 guidance.

PLCOm2012 screening eligibility, however, are based on a complicated risk factor assessments that include race but also education level and other factors which might not be readily available in electronic records. USPSTF’s criteria “are much more straightforward to use in a clinical setting,” the investigators noted.

Study subjects were 21-89 years old and were in their early 60s, on average. Just over half were women. The analysis excluded lung cancer patients and controls who had never smoked.

The authors noted some limitations, including the retrospective nature of the study, plus, few lung cancers were diagnosed among the control group, which were not only small, but they did not include follow-ups with CT scans.

The work was funded by the National Institutes of Health and the Herrick Foundation. Dr. Pu didn’t have any commercial disclosures. One investigator disclosed personal fees from Takeda, AstraZeneca, Genentech/Roche, Pfizer, and other companies. Dr. Erkmen reported an American Cancer Society-Pfizer Award to address disparities.

When asked, young people report that their reasons for starting smoking include rebellion, a new thing to try, and a peer social activity, among others. While you recognize these as developmentally expected drives, it is frustrating and scary that youth don’t realize how their brains are especially sensitive to permanent changes from nicotine.

Smoking even five packs of cigarettes is enough to cause addiction in youth; an influence as powerful as for cocaine or heroin. One pod of a vaping device delivers as much nicotine as one to five packs of cigarettes, depending on the strength and brand. There are no standards for this content and youth often are unaware of any nicotine and chemicals in vapes. Over 90% of adult smokers started before age 18, some as young as 6, mainly because quitting is so difficult. Cigarettes and vaping are not the only sources of nicotine used by youth; others are oral tobacco (chewing tobacco and dip), cigars, pipes, snus (between cheek and gum), hookahs, electronic devices, bidis (tobacco in a tendu leaf), kreteks (tobacco with cloves), and dissolvable tobacco products. Many youth use both cigarettes and noncigarette tobacco.

Given these predispositions, short-term COVID-19 and asthma exacerbation, and the long-lasting detriment of smoking on neurological, cardiac, pulmonary, and emotional health, actually the “leading preventable cause of death,” our job as pediatric providers is to do our best to prevent smoking/vaping or help our patients quit. But adolescent development is notoriously characterized by short-term thinking and feeling immune from long-term health consequences. So what approach has the best results? Focus on aspects of smoking important to the youth now, such as sports performance, bad breath, social stigma, insomnia, cost, lack of benefit for weight loss, and hazardous waste produced. Add to that loss of independence and being manipulated by Big Business by getting them (and targeted minorities) hooked may be salient in our discussion.

Even a brief 3-minute discussion using the AAC (Ask/Assess, Advise, Connect) format has shown effectiveness in getting teens and adults to quit smoking. Our assessment needs to include asking the extent of current use and symptoms of dependence to inform the treatment plan. We need to use their trust in us to advise that quitting is the best thing they can do for their health.

If the youth’s readiness stage is “thinking about stopping” nicotine, our motivational interview–style discussion of pros and cons could include asking “How important is it to you to stop?” and “What are some things that would help you?” If they are open to trying to stop, advise them to set a quit date within 2 weeks and suggest reducing gradually before then (and schedule follow-up). The plan needs to include dealing with the inevitable urges by finding ways to avoid current triggers to smoke (e.g., certain school bathrooms, people drinking or smoking, or stress over homework, conflict at home, etc.). Encourage exercise and meditation to distract and deal with the anxiety; asking family to quit; having a snack handy (such as sugarless gum or sunflower seeds) for when oral cravings develop; and setting rewards for early days of smoke-free success. We need to inform youth that using e-cigs actually reduces rates of success in quitting.

We need to warn youth of the withdrawal symptoms and their usual course when quitting: cravings each lasting 15-20 minutes (starting at 1/2-4 hours); restlessness, sadness, hopelessness (10 hours); irritability, trouble concentrating, insomnia, hunger and weight gain (5-10 pounds over 2 weeks, starting 24 hrs); headaches, dizziness, fatigue (starting 2 days); and anxiety (starting 3 days). There tends to be less brain fog, and less hunger after 2-4 weeks, but depression, anxiety, irritability, cough, constipation, and even suicidal thoughts may last weeks to months. Sounds nasty, right? No wonder quitting is so hard.

Support is crucial to quitting and staying off nicotine. You can provide this but, in addition to friends and family, we should connect youth to free ongoing phone counselors (1-800-QUIT-NOW or 877-44U-QUIT for Spanish), text services (text QUIT to 47848), apps (quit START), or community support.

While behavioral treatments are best for youth with minimal to mild dependence, risk of relapse is minimized with fewer withdrawal symptoms, thus the role for nicotine replacement therapy (NRT) for those with moderate to strong dependence and to help anyone ad lib with cravings. NRT is recommended by the American Academy of Pediatrics (AAP) to supplement counseling, although NRT is not Food and Drug Administration approved and requires a prescription for those under 18.

How can we determine the degree of dependence? Smoking more than 15 cigarettes per day (or vape equivalent) and inhaling even “seldom” counts as “moderate” dependence and more than 26 with difficulty refraining in several situations as “substantial” in the Fagerstrom Tolerance test. Early morning smoking is asked about, important to which NRT to use (gum or lozenge for faster onset). The Hooked on Nicotine Checklist assesses “loss of autonomy” over smoking by any “yes” item and is incorporated in the CRAFFT screen. The recommended dose of NRT and length of weaning is greater in substantial addiction versus moderate. Besides gum, lozenges, patch, inhaler, and nasal spray, you can prescribe bupropion (Wellbutrin or Zyban) or varenicline (Chantix), making note of the black box suicide warning. Combining NRTs is similarly effective compared with varenicline.

Relapse after quitting is more common than not. As for any chronic condition, in relapse we need to query adherence, and consider increasing NRT dose or wean duration, even years. Discussion should have a positive focus on “what was learned” from past attempts in making a new plan that incorporates Relevance, Risks, Rewards, Roadblocks, and Repetition.

Many youth smokers start because their parents smoke. While addressing adults may seem out of scope, we often treat parents when managing scabies, pinworms, meningococcal disease, and even depression for the benefit of the child. The AAP recommends prescribing NRT for parents, when needed.

Nicotine dependence is a chronic relapsing condition with comorbidities of substance use and psychiatric disorders that requires similar monitoring and support as for other chronic conditions we manage and is more likely to shorten lifespan than many.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.
 

Reference

Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke, Pediatrics 2015;136(5):1008-17. doi: 10.1542/peds.2015-31088.

When asked, young people report that their reasons for starting smoking include rebellion, a new thing to try, and a peer social activity, among others. While you recognize these as developmentally expected drives, it is frustrating and scary that youth don’t realize how their brains are especially sensitive to permanent changes from nicotine.

Smoking even five packs of cigarettes is enough to cause addiction in youth; an influence as powerful as for cocaine or heroin. One pod of a vaping device delivers as much nicotine as one to five packs of cigarettes, depending on the strength and brand. There are no standards for this content and youth often are unaware of any nicotine and chemicals in vapes. Over 90% of adult smokers started before age 18, some as young as 6, mainly because quitting is so difficult. Cigarettes and vaping are not the only sources of nicotine used by youth; others are oral tobacco (chewing tobacco and dip), cigars, pipes, snus (between cheek and gum), hookahs, electronic devices, bidis (tobacco in a tendu leaf), kreteks (tobacco with cloves), and dissolvable tobacco products. Many youth use both cigarettes and noncigarette tobacco.

Given these predispositions, short-term COVID-19 and asthma exacerbation, and the long-lasting detriment of smoking on neurological, cardiac, pulmonary, and emotional health, actually the “leading preventable cause of death,” our job as pediatric providers is to do our best to prevent smoking/vaping or help our patients quit. But adolescent development is notoriously characterized by short-term thinking and feeling immune from long-term health consequences. So what approach has the best results? Focus on aspects of smoking important to the youth now, such as sports performance, bad breath, social stigma, insomnia, cost, lack of benefit for weight loss, and hazardous waste produced. Add to that loss of independence and being manipulated by Big Business by getting them (and targeted minorities) hooked may be salient in our discussion.

Even a brief 3-minute discussion using the AAC (Ask/Assess, Advise, Connect) format has shown effectiveness in getting teens and adults to quit smoking. Our assessment needs to include asking the extent of current use and symptoms of dependence to inform the treatment plan. We need to use their trust in us to advise that quitting is the best thing they can do for their health.

If the youth’s readiness stage is “thinking about stopping” nicotine, our motivational interview–style discussion of pros and cons could include asking “How important is it to you to stop?” and “What are some things that would help you?” If they are open to trying to stop, advise them to set a quit date within 2 weeks and suggest reducing gradually before then (and schedule follow-up). The plan needs to include dealing with the inevitable urges by finding ways to avoid current triggers to smoke (e.g., certain school bathrooms, people drinking or smoking, or stress over homework, conflict at home, etc.). Encourage exercise and meditation to distract and deal with the anxiety; asking family to quit; having a snack handy (such as sugarless gum or sunflower seeds) for when oral cravings develop; and setting rewards for early days of smoke-free success. We need to inform youth that using e-cigs actually reduces rates of success in quitting.

We need to warn youth of the withdrawal symptoms and their usual course when quitting: cravings each lasting 15-20 minutes (starting at 1/2-4 hours); restlessness, sadness, hopelessness (10 hours); irritability, trouble concentrating, insomnia, hunger and weight gain (5-10 pounds over 2 weeks, starting 24 hrs); headaches, dizziness, fatigue (starting 2 days); and anxiety (starting 3 days). There tends to be less brain fog, and less hunger after 2-4 weeks, but depression, anxiety, irritability, cough, constipation, and even suicidal thoughts may last weeks to months. Sounds nasty, right? No wonder quitting is so hard.

Support is crucial to quitting and staying off nicotine. You can provide this but, in addition to friends and family, we should connect youth to free ongoing phone counselors (1-800-QUIT-NOW or 877-44U-QUIT for Spanish), text services (text QUIT to 47848), apps (quit START), or community support.

While behavioral treatments are best for youth with minimal to mild dependence, risk of relapse is minimized with fewer withdrawal symptoms, thus the role for nicotine replacement therapy (NRT) for those with moderate to strong dependence and to help anyone ad lib with cravings. NRT is recommended by the American Academy of Pediatrics (AAP) to supplement counseling, although NRT is not Food and Drug Administration approved and requires a prescription for those under 18.

How can we determine the degree of dependence? Smoking more than 15 cigarettes per day (or vape equivalent) and inhaling even “seldom” counts as “moderate” dependence and more than 26 with difficulty refraining in several situations as “substantial” in the Fagerstrom Tolerance test. Early morning smoking is asked about, important to which NRT to use (gum or lozenge for faster onset). The Hooked on Nicotine Checklist assesses “loss of autonomy” over smoking by any “yes” item and is incorporated in the CRAFFT screen. The recommended dose of NRT and length of weaning is greater in substantial addiction versus moderate. Besides gum, lozenges, patch, inhaler, and nasal spray, you can prescribe bupropion (Wellbutrin or Zyban) or varenicline (Chantix), making note of the black box suicide warning. Combining NRTs is similarly effective compared with varenicline.

Relapse after quitting is more common than not. As for any chronic condition, in relapse we need to query adherence, and consider increasing NRT dose or wean duration, even years. Discussion should have a positive focus on “what was learned” from past attempts in making a new plan that incorporates Relevance, Risks, Rewards, Roadblocks, and Repetition.

Many youth smokers start because their parents smoke. While addressing adults may seem out of scope, we often treat parents when managing scabies, pinworms, meningococcal disease, and even depression for the benefit of the child. The AAP recommends prescribing NRT for parents, when needed.

Nicotine dependence is a chronic relapsing condition with comorbidities of substance use and psychiatric disorders that requires similar monitoring and support as for other chronic conditions we manage and is more likely to shorten lifespan than many.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.
 

Reference

Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke, Pediatrics 2015;136(5):1008-17. doi: 10.1542/peds.2015-31088.

When asked, young people report that their reasons for starting smoking include rebellion, a new thing to try, and a peer social activity, among others. While you recognize these as developmentally expected drives, it is frustrating and scary that youth don’t realize how their brains are especially sensitive to permanent changes from nicotine.

Smoking even five packs of cigarettes is enough to cause addiction in youth; an influence as powerful as for cocaine or heroin. One pod of a vaping device delivers as much nicotine as one to five packs of cigarettes, depending on the strength and brand. There are no standards for this content and youth often are unaware of any nicotine and chemicals in vapes. Over 90% of adult smokers started before age 18, some as young as 6, mainly because quitting is so difficult. Cigarettes and vaping are not the only sources of nicotine used by youth; others are oral tobacco (chewing tobacco and dip), cigars, pipes, snus (between cheek and gum), hookahs, electronic devices, bidis (tobacco in a tendu leaf), kreteks (tobacco with cloves), and dissolvable tobacco products. Many youth use both cigarettes and noncigarette tobacco.

Given these predispositions, short-term COVID-19 and asthma exacerbation, and the long-lasting detriment of smoking on neurological, cardiac, pulmonary, and emotional health, actually the “leading preventable cause of death,” our job as pediatric providers is to do our best to prevent smoking/vaping or help our patients quit. But adolescent development is notoriously characterized by short-term thinking and feeling immune from long-term health consequences. So what approach has the best results? Focus on aspects of smoking important to the youth now, such as sports performance, bad breath, social stigma, insomnia, cost, lack of benefit for weight loss, and hazardous waste produced. Add to that loss of independence and being manipulated by Big Business by getting them (and targeted minorities) hooked may be salient in our discussion.

Even a brief 3-minute discussion using the AAC (Ask/Assess, Advise, Connect) format has shown effectiveness in getting teens and adults to quit smoking. Our assessment needs to include asking the extent of current use and symptoms of dependence to inform the treatment plan. We need to use their trust in us to advise that quitting is the best thing they can do for their health.

If the youth’s readiness stage is “thinking about stopping” nicotine, our motivational interview–style discussion of pros and cons could include asking “How important is it to you to stop?” and “What are some things that would help you?” If they are open to trying to stop, advise them to set a quit date within 2 weeks and suggest reducing gradually before then (and schedule follow-up). The plan needs to include dealing with the inevitable urges by finding ways to avoid current triggers to smoke (e.g., certain school bathrooms, people drinking or smoking, or stress over homework, conflict at home, etc.). Encourage exercise and meditation to distract and deal with the anxiety; asking family to quit; having a snack handy (such as sugarless gum or sunflower seeds) for when oral cravings develop; and setting rewards for early days of smoke-free success. We need to inform youth that using e-cigs actually reduces rates of success in quitting.

We need to warn youth of the withdrawal symptoms and their usual course when quitting: cravings each lasting 15-20 minutes (starting at 1/2-4 hours); restlessness, sadness, hopelessness (10 hours); irritability, trouble concentrating, insomnia, hunger and weight gain (5-10 pounds over 2 weeks, starting 24 hrs); headaches, dizziness, fatigue (starting 2 days); and anxiety (starting 3 days). There tends to be less brain fog, and less hunger after 2-4 weeks, but depression, anxiety, irritability, cough, constipation, and even suicidal thoughts may last weeks to months. Sounds nasty, right? No wonder quitting is so hard.

Support is crucial to quitting and staying off nicotine. You can provide this but, in addition to friends and family, we should connect youth to free ongoing phone counselors (1-800-QUIT-NOW or 877-44U-QUIT for Spanish), text services (text QUIT to 47848), apps (quit START), or community support.

While behavioral treatments are best for youth with minimal to mild dependence, risk of relapse is minimized with fewer withdrawal symptoms, thus the role for nicotine replacement therapy (NRT) for those with moderate to strong dependence and to help anyone ad lib with cravings. NRT is recommended by the American Academy of Pediatrics (AAP) to supplement counseling, although NRT is not Food and Drug Administration approved and requires a prescription for those under 18.

How can we determine the degree of dependence? Smoking more than 15 cigarettes per day (or vape equivalent) and inhaling even “seldom” counts as “moderate” dependence and more than 26 with difficulty refraining in several situations as “substantial” in the Fagerstrom Tolerance test. Early morning smoking is asked about, important to which NRT to use (gum or lozenge for faster onset). The Hooked on Nicotine Checklist assesses “loss of autonomy” over smoking by any “yes” item and is incorporated in the CRAFFT screen. The recommended dose of NRT and length of weaning is greater in substantial addiction versus moderate. Besides gum, lozenges, patch, inhaler, and nasal spray, you can prescribe bupropion (Wellbutrin or Zyban) or varenicline (Chantix), making note of the black box suicide warning. Combining NRTs is similarly effective compared with varenicline.

Relapse after quitting is more common than not. As for any chronic condition, in relapse we need to query adherence, and consider increasing NRT dose or wean duration, even years. Discussion should have a positive focus on “what was learned” from past attempts in making a new plan that incorporates Relevance, Risks, Rewards, Roadblocks, and Repetition.

Many youth smokers start because their parents smoke. While addressing adults may seem out of scope, we often treat parents when managing scabies, pinworms, meningococcal disease, and even depression for the benefit of the child. The AAP recommends prescribing NRT for parents, when needed.

Nicotine dependence is a chronic relapsing condition with comorbidities of substance use and psychiatric disorders that requires similar monitoring and support as for other chronic conditions we manage and is more likely to shorten lifespan than many.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at pdnews@mdedge.com.
 

Reference

Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke, Pediatrics 2015;136(5):1008-17. doi: 10.1542/peds.2015-31088.

Topline results from the phase 1 APOLLO study of SLN360, a short interfering ribonucleic acid (siRNA) targeting lipoprotein(a), showed it significantly reduced Lp(a) in a dose-dependent manner from 46% to up to 98%.

Reductions of up to 81% were maintained out to 150 days, according to a release from the developer of the drug, Silence Therapeutics.

High Lp(a) affects about one in five people worldwide and is a genetic risk factor for cardiovascular disease. There are no approved medications that selectively lower Lp(a), and levels cannot be significantly modified through lifestyle changes or any approved medications.

SLN360 is a siRNA that is designed to lower Lp(a) production by using the body’s natural process of RNA interference to target and silence messenger RNA transcribed from the LPA gene in liver cells.

The first-in-human APOLLO trial evaluated 32 patients with serum Lp(a) concentrations of at least 150 nmol/L and no cardiovascular disease who received a single subcutaneous dose of SLN360 (30 mg, 100 mg, less than or equal to 300 mg, or less than or equal to 600 mg) or placebo and were followed for up to 150 days.

No clinically important safety concerns were identified, although low-grade adverse events at the injection site occurred, most prominently at the highest dose, according to the company.

Study follow-up has been extended to 1 year. Patient enrollment continues in the multiple-ascending dose portion of the phase 1 study in patients with high Lp(a) and a confirmed history of stable atherosclerotic cardiovascular disease, the company statement notes.

Detailed results from APOLLO will be presented in a late-breaking clinical trials session at the American College of Cardiology Annual Scientific Session on April 3 by principal investigator Steven E. Nissen, MD, Cleveland Clinic.

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

Topline results from the phase 1 APOLLO study of SLN360, a short interfering ribonucleic acid (siRNA) targeting lipoprotein(a), showed it significantly reduced Lp(a) in a dose-dependent manner from 46% to up to 98%.

Reductions of up to 81% were maintained out to 150 days, according to a release from the developer of the drug, Silence Therapeutics.

High Lp(a) affects about one in five people worldwide and is a genetic risk factor for cardiovascular disease. There are no approved medications that selectively lower Lp(a), and levels cannot be significantly modified through lifestyle changes or any approved medications.

SLN360 is a siRNA that is designed to lower Lp(a) production by using the body’s natural process of RNA interference to target and silence messenger RNA transcribed from the LPA gene in liver cells.

The first-in-human APOLLO trial evaluated 32 patients with serum Lp(a) concentrations of at least 150 nmol/L and no cardiovascular disease who received a single subcutaneous dose of SLN360 (30 mg, 100 mg, less than or equal to 300 mg, or less than or equal to 600 mg) or placebo and were followed for up to 150 days.

No clinically important safety concerns were identified, although low-grade adverse events at the injection site occurred, most prominently at the highest dose, according to the company.

Study follow-up has been extended to 1 year. Patient enrollment continues in the multiple-ascending dose portion of the phase 1 study in patients with high Lp(a) and a confirmed history of stable atherosclerotic cardiovascular disease, the company statement notes.

Detailed results from APOLLO will be presented in a late-breaking clinical trials session at the American College of Cardiology Annual Scientific Session on April 3 by principal investigator Steven E. Nissen, MD, Cleveland Clinic.

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

Topline results from the phase 1 APOLLO study of SLN360, a short interfering ribonucleic acid (siRNA) targeting lipoprotein(a), showed it significantly reduced Lp(a) in a dose-dependent manner from 46% to up to 98%.

Reductions of up to 81% were maintained out to 150 days, according to a release from the developer of the drug, Silence Therapeutics.

High Lp(a) affects about one in five people worldwide and is a genetic risk factor for cardiovascular disease. There are no approved medications that selectively lower Lp(a), and levels cannot be significantly modified through lifestyle changes or any approved medications.

SLN360 is a siRNA that is designed to lower Lp(a) production by using the body’s natural process of RNA interference to target and silence messenger RNA transcribed from the LPA gene in liver cells.

The first-in-human APOLLO trial evaluated 32 patients with serum Lp(a) concentrations of at least 150 nmol/L and no cardiovascular disease who received a single subcutaneous dose of SLN360 (30 mg, 100 mg, less than or equal to 300 mg, or less than or equal to 600 mg) or placebo and were followed for up to 150 days.

No clinically important safety concerns were identified, although low-grade adverse events at the injection site occurred, most prominently at the highest dose, according to the company.

Study follow-up has been extended to 1 year. Patient enrollment continues in the multiple-ascending dose portion of the phase 1 study in patients with high Lp(a) and a confirmed history of stable atherosclerotic cardiovascular disease, the company statement notes.

Detailed results from APOLLO will be presented in a late-breaking clinical trials session at the American College of Cardiology Annual Scientific Session on April 3 by principal investigator Steven E. Nissen, MD, Cleveland Clinic.

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

In the treatment of male androgenetic alopecia (AGA), low-dose dutasteride (0.5 mg/day), used off label in the United States, tops a ranking of the most commonly used oral and topical agents in a new meta-analysis.

While up to 90% of men experience AGA in their lifetime, only three therapies are currently approved for treatment of the condition by the Food and Drug Administration – topical minoxidil, oral finasteride 1 mg, and low-level light therapy.

However, with common use of off-label oral minoxidil, as well as oral dutasteride and higher doses of oral finasteride, the latter two being 5-alpha reductase inhibitors, Aditya K. Gupta, MD, PhD, of Mediprobe Research, in London, Ont., and colleagues sought to compare the data on the three agents. Their results were published in JAMA Dermatology.

They note that, while there have been recent comparisons between oral and topical minoxidil, “to our knowledge no study has determined the comparative effectiveness of these 2 [formulations] with that of local and systemic dutasteride and finasteride.”

For the meta-analysis, the authors identified 23 studies meeting their criteria, involving patients with mean ages ranging from 22.8 to 41.8 years.

For the primary endpoint of the greatest increases in total hair count at 24 weeks, the analysis showed the 0.5-mg/day dose of dutasteride topped the list, with significantly greater efficacy, compared with 1 mg/day of finasteride (mean difference, 7.1 hairs per cm²).

The 0.5-mg/d dutasteride dose also showed higher efficacy than oral minoxidil at 0.25 mg/day (mean difference, 23.7 hairs per cm²) and 5 mg/day (mean difference, 15.0 hairs per cm²) and topical minoxidil at 2% (mean difference, 8.5 hairs per cm²).

For the secondary endpoint of the greatest increase in terminal hair count at 24 weeks, the 5-mg/day dose of minoxidil had significantly greater efficacy compared with the 0.25-mg/day dose of the drug, as well as with minoxidil’s 2% and 5% topical formulations.

The minoxidil 5-mg/day dose was also significantly more effective than 1 mg/day of finasteride for terminal hair count at 24 weeks.

In longer-term outcomes at 48 weeks, the greatest increase in total hair count at 48 weeks was observed with 5 mg/day of finasteride, which was significantly more effective, compared with 2% topical minoxidil.

And the greatest increase in terminal hair count at 48 weeks was observed with 1 mg/day of oral finasteride, which was significantly more effective than 2% as well as 5% topical minoxidil.

Based on the results, the authors ranked the agents in a decreasing order of efficacy: 0.5 mg/day of oral dutasteride, 5 mg/day of oral finasteride, 5 mg/day of oral minoxidil, 1 mg/day of oral finasteride, 5% topical minoxidil, 2% topical minoxidil, and 0.25 mg/day of oral minoxidil.

Commenting on the analysis in an accompanying editorial, Kathie P. Huang, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, and Maryanne M. Senna, MD, of the department of dermatology, Massachusetts General Hospital, Boston, said the results, in general, are consistent with their experiences, noting that 2% minoxidil is typically not used in men.

They noted that, “although topical minoxidil ranked higher than the very-low-dose 0.25 mg oral minoxidil, our personal experience is that oral minoxidil at doses of 1.25 mg to 5 mg are far superior to topical minoxidil for treating AGA.”

Adverse event considerations important

Importantly, however, strong consideration needs to be given to adverse-event profiles, as well as patient comorbidities in selecting agents, the editorial authors asserted.

With 1 mg finasteride, for instance, potential adverse events include decreased libido, erectile dysfunction, decreased ejaculatory volume, reduction in sperm count, testicular pain, depression, and gynecomastia, they noted.

And while finasteride appears to be associated with a decreased risk of prostate cancer, those receiving the drug who do develop prostate cancer may be diagnosed with higher-grade prostate cancer; however, that “might be related to tissue sampling artifact,” the editorial authors said.

Less has been published on dutasteride’s adverse-event profile, and that, in itself, is a concern.

Dr. Antonella Tosti

Overall, “as more direct-to-consumer companies treating male AGA emerge, it is especially important that the potential risks of these medications be made clear to patients,” they added.

Further commenting on the analysis to this news organization, Antonella Tosti, MD, the Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery at the University of Miami, said the study offers some important insights – and caveats.

“I think this is a very interesting study, but you have to consider what works for your patients,” she said.

Dr. Tosti noted that the 5-mg dose of minoxidil is a concern in terms of side effects. “That dose is pretty high and could feasibly cause some hypertrichosis, which can be a concern to men as well as women.”

She agrees that the lack of data on side effects with dutasteride is also a concern, especially in light of some of the known side effects with other agents.

“That’s why I don’t use it very much in younger patients – because I’m afraid it could potentially affect their fertility,” Dr. Tosti said.

In general, Dr. Tosti said she finds a combination of agents provides the best results, as many clinicians use.

“I find dutasteride (0.5 mg/day) plus oral minoxidil (1-2.5 mg/day) plus topical 5% minoxidil is the best combination,” she said.

The authors and Dr. Tosti disclosed no relevant financial relationships.

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

In the treatment of male androgenetic alopecia (AGA), low-dose dutasteride (0.5 mg/day), used off label in the United States, tops a ranking of the most commonly used oral and topical agents in a new meta-analysis.

While up to 90% of men experience AGA in their lifetime, only three therapies are currently approved for treatment of the condition by the Food and Drug Administration – topical minoxidil, oral finasteride 1 mg, and low-level light therapy.

However, with common use of off-label oral minoxidil, as well as oral dutasteride and higher doses of oral finasteride, the latter two being 5-alpha reductase inhibitors, Aditya K. Gupta, MD, PhD, of Mediprobe Research, in London, Ont., and colleagues sought to compare the data on the three agents. Their results were published in JAMA Dermatology.

They note that, while there have been recent comparisons between oral and topical minoxidil, “to our knowledge no study has determined the comparative effectiveness of these 2 [formulations] with that of local and systemic dutasteride and finasteride.”

For the meta-analysis, the authors identified 23 studies meeting their criteria, involving patients with mean ages ranging from 22.8 to 41.8 years.

For the primary endpoint of the greatest increases in total hair count at 24 weeks, the analysis showed the 0.5-mg/day dose of dutasteride topped the list, with significantly greater efficacy, compared with 1 mg/day of finasteride (mean difference, 7.1 hairs per cm²).

The 0.5-mg/d dutasteride dose also showed higher efficacy than oral minoxidil at 0.25 mg/day (mean difference, 23.7 hairs per cm²) and 5 mg/day (mean difference, 15.0 hairs per cm²) and topical minoxidil at 2% (mean difference, 8.5 hairs per cm²).

For the secondary endpoint of the greatest increase in terminal hair count at 24 weeks, the 5-mg/day dose of minoxidil had significantly greater efficacy compared with the 0.25-mg/day dose of the drug, as well as with minoxidil’s 2% and 5% topical formulations.

The minoxidil 5-mg/day dose was also significantly more effective than 1 mg/day of finasteride for terminal hair count at 24 weeks.

In longer-term outcomes at 48 weeks, the greatest increase in total hair count at 48 weeks was observed with 5 mg/day of finasteride, which was significantly more effective, compared with 2% topical minoxidil.

And the greatest increase in terminal hair count at 48 weeks was observed with 1 mg/day of oral finasteride, which was significantly more effective than 2% as well as 5% topical minoxidil.

Based on the results, the authors ranked the agents in a decreasing order of efficacy: 0.5 mg/day of oral dutasteride, 5 mg/day of oral finasteride, 5 mg/day of oral minoxidil, 1 mg/day of oral finasteride, 5% topical minoxidil, 2% topical minoxidil, and 0.25 mg/day of oral minoxidil.

Commenting on the analysis in an accompanying editorial, Kathie P. Huang, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, and Maryanne M. Senna, MD, of the department of dermatology, Massachusetts General Hospital, Boston, said the results, in general, are consistent with their experiences, noting that 2% minoxidil is typically not used in men.

They noted that, “although topical minoxidil ranked higher than the very-low-dose 0.25 mg oral minoxidil, our personal experience is that oral minoxidil at doses of 1.25 mg to 5 mg are far superior to topical minoxidil for treating AGA.”

Adverse event considerations important

Importantly, however, strong consideration needs to be given to adverse-event profiles, as well as patient comorbidities in selecting agents, the editorial authors asserted.

With 1 mg finasteride, for instance, potential adverse events include decreased libido, erectile dysfunction, decreased ejaculatory volume, reduction in sperm count, testicular pain, depression, and gynecomastia, they noted.

And while finasteride appears to be associated with a decreased risk of prostate cancer, those receiving the drug who do develop prostate cancer may be diagnosed with higher-grade prostate cancer; however, that “might be related to tissue sampling artifact,” the editorial authors said.

Less has been published on dutasteride’s adverse-event profile, and that, in itself, is a concern.

Dr. Antonella Tosti

Overall, “as more direct-to-consumer companies treating male AGA emerge, it is especially important that the potential risks of these medications be made clear to patients,” they added.

Further commenting on the analysis to this news organization, Antonella Tosti, MD, the Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery at the University of Miami, said the study offers some important insights – and caveats.

“I think this is a very interesting study, but you have to consider what works for your patients,” she said.

Dr. Tosti noted that the 5-mg dose of minoxidil is a concern in terms of side effects. “That dose is pretty high and could feasibly cause some hypertrichosis, which can be a concern to men as well as women.”

She agrees that the lack of data on side effects with dutasteride is also a concern, especially in light of some of the known side effects with other agents.

“That’s why I don’t use it very much in younger patients – because I’m afraid it could potentially affect their fertility,” Dr. Tosti said.

In general, Dr. Tosti said she finds a combination of agents provides the best results, as many clinicians use.

“I find dutasteride (0.5 mg/day) plus oral minoxidil (1-2.5 mg/day) plus topical 5% minoxidil is the best combination,” she said.

The authors and Dr. Tosti disclosed no relevant financial relationships.

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

In the treatment of male androgenetic alopecia (AGA), low-dose dutasteride (0.5 mg/day), used off label in the United States, tops a ranking of the most commonly used oral and topical agents in a new meta-analysis.

While up to 90% of men experience AGA in their lifetime, only three therapies are currently approved for treatment of the condition by the Food and Drug Administration – topical minoxidil, oral finasteride 1 mg, and low-level light therapy.

However, with common use of off-label oral minoxidil, as well as oral dutasteride and higher doses of oral finasteride, the latter two being 5-alpha reductase inhibitors, Aditya K. Gupta, MD, PhD, of Mediprobe Research, in London, Ont., and colleagues sought to compare the data on the three agents. Their results were published in JAMA Dermatology.

They note that, while there have been recent comparisons between oral and topical minoxidil, “to our knowledge no study has determined the comparative effectiveness of these 2 [formulations] with that of local and systemic dutasteride and finasteride.”

For the meta-analysis, the authors identified 23 studies meeting their criteria, involving patients with mean ages ranging from 22.8 to 41.8 years.

For the primary endpoint of the greatest increases in total hair count at 24 weeks, the analysis showed the 0.5-mg/day dose of dutasteride topped the list, with significantly greater efficacy, compared with 1 mg/day of finasteride (mean difference, 7.1 hairs per cm²).

The 0.5-mg/d dutasteride dose also showed higher efficacy than oral minoxidil at 0.25 mg/day (mean difference, 23.7 hairs per cm²) and 5 mg/day (mean difference, 15.0 hairs per cm²) and topical minoxidil at 2% (mean difference, 8.5 hairs per cm²).

For the secondary endpoint of the greatest increase in terminal hair count at 24 weeks, the 5-mg/day dose of minoxidil had significantly greater efficacy compared with the 0.25-mg/day dose of the drug, as well as with minoxidil’s 2% and 5% topical formulations.

The minoxidil 5-mg/day dose was also significantly more effective than 1 mg/day of finasteride for terminal hair count at 24 weeks.

In longer-term outcomes at 48 weeks, the greatest increase in total hair count at 48 weeks was observed with 5 mg/day of finasteride, which was significantly more effective, compared with 2% topical minoxidil.

And the greatest increase in terminal hair count at 48 weeks was observed with 1 mg/day of oral finasteride, which was significantly more effective than 2% as well as 5% topical minoxidil.

Based on the results, the authors ranked the agents in a decreasing order of efficacy: 0.5 mg/day of oral dutasteride, 5 mg/day of oral finasteride, 5 mg/day of oral minoxidil, 1 mg/day of oral finasteride, 5% topical minoxidil, 2% topical minoxidil, and 0.25 mg/day of oral minoxidil.

Commenting on the analysis in an accompanying editorial, Kathie P. Huang, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, and Maryanne M. Senna, MD, of the department of dermatology, Massachusetts General Hospital, Boston, said the results, in general, are consistent with their experiences, noting that 2% minoxidil is typically not used in men.

They noted that, “although topical minoxidil ranked higher than the very-low-dose 0.25 mg oral minoxidil, our personal experience is that oral minoxidil at doses of 1.25 mg to 5 mg are far superior to topical minoxidil for treating AGA.”

Adverse event considerations important

Importantly, however, strong consideration needs to be given to adverse-event profiles, as well as patient comorbidities in selecting agents, the editorial authors asserted.

With 1 mg finasteride, for instance, potential adverse events include decreased libido, erectile dysfunction, decreased ejaculatory volume, reduction in sperm count, testicular pain, depression, and gynecomastia, they noted.

And while finasteride appears to be associated with a decreased risk of prostate cancer, those receiving the drug who do develop prostate cancer may be diagnosed with higher-grade prostate cancer; however, that “might be related to tissue sampling artifact,” the editorial authors said.

Less has been published on dutasteride’s adverse-event profile, and that, in itself, is a concern.

Dr. Antonella Tosti

Overall, “as more direct-to-consumer companies treating male AGA emerge, it is especially important that the potential risks of these medications be made clear to patients,” they added.

Further commenting on the analysis to this news organization, Antonella Tosti, MD, the Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery at the University of Miami, said the study offers some important insights – and caveats.

“I think this is a very interesting study, but you have to consider what works for your patients,” she said.

Dr. Tosti noted that the 5-mg dose of minoxidil is a concern in terms of side effects. “That dose is pretty high and could feasibly cause some hypertrichosis, which can be a concern to men as well as women.”

She agrees that the lack of data on side effects with dutasteride is also a concern, especially in light of some of the known side effects with other agents.

“That’s why I don’t use it very much in younger patients – because I’m afraid it could potentially affect their fertility,” Dr. Tosti said.

In general, Dr. Tosti said she finds a combination of agents provides the best results, as many clinicians use.

“I find dutasteride (0.5 mg/day) plus oral minoxidil (1-2.5 mg/day) plus topical 5% minoxidil is the best combination,” she said.

The authors and Dr. Tosti disclosed no relevant financial relationships.

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

The “Cancer Moonshot” is about to be relaunched.

In a White House briefing, President Joe Biden announced that he is “reigniting” the initiative he spearheaded when he was vice president during the Obama administration.

During the livestreamed event, the president discussed his plans to bring a “fierce sense of urgency” to the fight against cancer and better support patients with cancer and their families.

He emphasized that cancer is one of the truly bipartisan issues. There is strong support from both “sides of the aisle,” he said, and he sees it as an issue that can bring the country together.

“We can do this. I promise you, we can do this. For all those we lost, for all those we miss. We can end cancer as we know it,” he said. “This is a presidential White House priority.”

The aim is to reduce the death rate from cancer by at least 50% over the next 25 years.

One of the efforts will be directed to get people back to routine cancer screenings, such as mammograms and colonoscopies, with a special focus on ensuring equitable access.

There is also a proposal to create the Advanced Research Projects Agency for Health, which would focus on driving cutting-edge innovation in health research.

Part of the plan is to assemble a “cancer cabinet” that includes 18 federal departments, agencies, and offices, including leaders from the departments of Health & Human Services, Veterans Affairs, Defense, Energy, and Agriculture.

At present, there are few details about the new program or how it will be funded.

Presumably more will be revealed at the Cancer Moonshot Summit being planned, as well as on a planned new website where people can track its progress.
 

President priority

Cancer Moonshot began back in 2016, when during his last State of the Union Address, former President Barack Obama announced the ambitious initiative. A few days later, Obama asked Congress for $1 billion to send cancer to the moon, and he put Biden, then vice president, in charge of “mission control” in the remaining months of the administration.

The new initiative will be headed by Danielle Carnival, PhD, who serves in the White House Office of Science and Technology Policy and has been appointed as White House Cancer Moonshot coordinator.

At the briefing, Mr. Biden and Vice President Kamala Harris spoke about losing family members to cancer. The president spoke about his eldest son, Beau, who died from brain cancer when he was 46 years old, while Ms. Harris spoke about her mother, Shyamala Gopalan, a breast cancer researcher who died of colon cancer in 2009.
 

Accolades but a bit of caution

The president’s speech was applauded by many cancer groups, both professional organizations and patient advocacy groups.

Karen E. Knudsen, PhD, chief executive officer of the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network, commended Mr. Biden for reigniting Cancer Moonshot.

“In 2022 alone, there will be an estimated 1.9 million people diagnosed with cancer and more than 600,000 people in the U.S. will die. Marshaling the resources of the federal government will be critical in our ability to reduce death and suffering from this disease,” she said.

The American Society for Radiation Oncology issued a press release, saying: “On behalf of radiation oncologists who treat people with cancer every day, we support the Biden-Harris administration’s move to drastically reduce the number of cancer deaths in the United States and improve the lives of people diagnosed with this disease.

“We believe the administration’s commitment to expand cancer prevention efforts and to increase equitable access to screenings and treatments will help mitigate some of the negative impact of the COVID-19 pandemic,” the society added.

At the American Association for Cancer Research, Chief Executive Officer Margaret Foti, MD, PhD, said she was thrilled to hear the announcement after the devastating interruptions in cancer research and patient care over the past 2 years.

“The reignited Cancer Moonshot will provide an important framework to help improve cancer prevention strategies, increase cancer screenings and early detection, reduce cancer disparities, and propel new lifesaving cures for patients with cancer,” she said.

However, increased funding from Congress will be needed for these goals to be achieved, she emphasized.

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

The “Cancer Moonshot” is about to be relaunched.

In a White House briefing, President Joe Biden announced that he is “reigniting” the initiative he spearheaded when he was vice president during the Obama administration.

During the livestreamed event, the president discussed his plans to bring a “fierce sense of urgency” to the fight against cancer and better support patients with cancer and their families.

He emphasized that cancer is one of the truly bipartisan issues. There is strong support from both “sides of the aisle,” he said, and he sees it as an issue that can bring the country together.

“We can do this. I promise you, we can do this. For all those we lost, for all those we miss. We can end cancer as we know it,” he said. “This is a presidential White House priority.”

The aim is to reduce the death rate from cancer by at least 50% over the next 25 years.

One of the efforts will be directed to get people back to routine cancer screenings, such as mammograms and colonoscopies, with a special focus on ensuring equitable access.

There is also a proposal to create the Advanced Research Projects Agency for Health, which would focus on driving cutting-edge innovation in health research.

Part of the plan is to assemble a “cancer cabinet” that includes 18 federal departments, agencies, and offices, including leaders from the departments of Health & Human Services, Veterans Affairs, Defense, Energy, and Agriculture.

At present, there are few details about the new program or how it will be funded.

Presumably more will be revealed at the Cancer Moonshot Summit being planned, as well as on a planned new website where people can track its progress.
 

President priority

Cancer Moonshot began back in 2016, when during his last State of the Union Address, former President Barack Obama announced the ambitious initiative. A few days later, Obama asked Congress for $1 billion to send cancer to the moon, and he put Biden, then vice president, in charge of “mission control” in the remaining months of the administration.

The new initiative will be headed by Danielle Carnival, PhD, who serves in the White House Office of Science and Technology Policy and has been appointed as White House Cancer Moonshot coordinator.

At the briefing, Mr. Biden and Vice President Kamala Harris spoke about losing family members to cancer. The president spoke about his eldest son, Beau, who died from brain cancer when he was 46 years old, while Ms. Harris spoke about her mother, Shyamala Gopalan, a breast cancer researcher who died of colon cancer in 2009.
 

Accolades but a bit of caution

The president’s speech was applauded by many cancer groups, both professional organizations and patient advocacy groups.

Karen E. Knudsen, PhD, chief executive officer of the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network, commended Mr. Biden for reigniting Cancer Moonshot.

“In 2022 alone, there will be an estimated 1.9 million people diagnosed with cancer and more than 600,000 people in the U.S. will die. Marshaling the resources of the federal government will be critical in our ability to reduce death and suffering from this disease,” she said.

The American Society for Radiation Oncology issued a press release, saying: “On behalf of radiation oncologists who treat people with cancer every day, we support the Biden-Harris administration’s move to drastically reduce the number of cancer deaths in the United States and improve the lives of people diagnosed with this disease.

“We believe the administration’s commitment to expand cancer prevention efforts and to increase equitable access to screenings and treatments will help mitigate some of the negative impact of the COVID-19 pandemic,” the society added.

At the American Association for Cancer Research, Chief Executive Officer Margaret Foti, MD, PhD, said she was thrilled to hear the announcement after the devastating interruptions in cancer research and patient care over the past 2 years.

“The reignited Cancer Moonshot will provide an important framework to help improve cancer prevention strategies, increase cancer screenings and early detection, reduce cancer disparities, and propel new lifesaving cures for patients with cancer,” she said.

However, increased funding from Congress will be needed for these goals to be achieved, she emphasized.

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

The “Cancer Moonshot” is about to be relaunched.

In a White House briefing, President Joe Biden announced that he is “reigniting” the initiative he spearheaded when he was vice president during the Obama administration.

During the livestreamed event, the president discussed his plans to bring a “fierce sense of urgency” to the fight against cancer and better support patients with cancer and their families.

He emphasized that cancer is one of the truly bipartisan issues. There is strong support from both “sides of the aisle,” he said, and he sees it as an issue that can bring the country together.

“We can do this. I promise you, we can do this. For all those we lost, for all those we miss. We can end cancer as we know it,” he said. “This is a presidential White House priority.”

The aim is to reduce the death rate from cancer by at least 50% over the next 25 years.

One of the efforts will be directed to get people back to routine cancer screenings, such as mammograms and colonoscopies, with a special focus on ensuring equitable access.

There is also a proposal to create the Advanced Research Projects Agency for Health, which would focus on driving cutting-edge innovation in health research.

Part of the plan is to assemble a “cancer cabinet” that includes 18 federal departments, agencies, and offices, including leaders from the departments of Health & Human Services, Veterans Affairs, Defense, Energy, and Agriculture.

At present, there are few details about the new program or how it will be funded.

Presumably more will be revealed at the Cancer Moonshot Summit being planned, as well as on a planned new website where people can track its progress.
 

President priority

Cancer Moonshot began back in 2016, when during his last State of the Union Address, former President Barack Obama announced the ambitious initiative. A few days later, Obama asked Congress for $1 billion to send cancer to the moon, and he put Biden, then vice president, in charge of “mission control” in the remaining months of the administration.

The new initiative will be headed by Danielle Carnival, PhD, who serves in the White House Office of Science and Technology Policy and has been appointed as White House Cancer Moonshot coordinator.

At the briefing, Mr. Biden and Vice President Kamala Harris spoke about losing family members to cancer. The president spoke about his eldest son, Beau, who died from brain cancer when he was 46 years old, while Ms. Harris spoke about her mother, Shyamala Gopalan, a breast cancer researcher who died of colon cancer in 2009.
 

Accolades but a bit of caution

The president’s speech was applauded by many cancer groups, both professional organizations and patient advocacy groups.

Karen E. Knudsen, PhD, chief executive officer of the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network, commended Mr. Biden for reigniting Cancer Moonshot.

“In 2022 alone, there will be an estimated 1.9 million people diagnosed with cancer and more than 600,000 people in the U.S. will die. Marshaling the resources of the federal government will be critical in our ability to reduce death and suffering from this disease,” she said.

The American Society for Radiation Oncology issued a press release, saying: “On behalf of radiation oncologists who treat people with cancer every day, we support the Biden-Harris administration’s move to drastically reduce the number of cancer deaths in the United States and improve the lives of people diagnosed with this disease.

“We believe the administration’s commitment to expand cancer prevention efforts and to increase equitable access to screenings and treatments will help mitigate some of the negative impact of the COVID-19 pandemic,” the society added.

At the American Association for Cancer Research, Chief Executive Officer Margaret Foti, MD, PhD, said she was thrilled to hear the announcement after the devastating interruptions in cancer research and patient care over the past 2 years.

“The reignited Cancer Moonshot will provide an important framework to help improve cancer prevention strategies, increase cancer screenings and early detection, reduce cancer disparities, and propel new lifesaving cures for patients with cancer,” she said.

However, increased funding from Congress will be needed for these goals to be achieved, she emphasized.

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

Catching all solid cancers before they metastasize could prevent 26% to 32% of cancer deaths in women and 18% to 24% in men within 10 years of diagnosis, researchers in Australia estimate.

Those figures translate to 2,064 to 2,677 fewer cancer deaths annually in the state of New South Wales between 2005 and 2014, the most recent period studied.

“While it is well established that diagnosing cancers at an earlier stage is ‘better,’ our study is unique in that it quantifies what that ‘better’ might look like in terms of how many deaths would be avoided within 10 years of diagnosis,” the authors write in an article published online Jan. 17 in the International Journal of Cancer. “By doing so, it is hoped that these results will provide continued motivation to develop more effective strategies to diagnose cancers at an earlier stage.”

Of course, achieving such a “stage-shift in practice is difficult,” study author Xue Qin Yu, PhD, of The Daffodil Centre in Sydney and colleagues, acknowledge. First, Dr. Yu and colleagues note, “diagnosis at an earlier stage can be challenging due to the nonspecific nature of many common symptoms which may not be recognized by either patients or doctors.” Plus, they add, a challenge for diagnosing cancers at an earlier stage “is the overall low uptake of screening.”

For their study, the researchers used data from a cohort of more than 716,000 people aged 15 to 89 years diagnosed with a solid cancer in New South Wales between 1985 and 2014 and followed through 2015.

To estimate how many deaths could be avoided if tumors were caught earlier, the authors looked at two scenarios. In scenario 1, they assumed all known cases of distant cancer were instead diagnosed at the regional stage, and in scenario 2, they assumed half of the cases were diagnosed as regional and half as localized disease.

Under the conservative scenario 1, about 18% of the observed cancer deaths in males and 26% in females could be avoided. In total, this corresponded to 21% of observed deaths.

Colorectal cancer topped the list of avoidable deaths in both men (27%) and women (33%), followed by prostate cancer in men (19%), breast cancer in women (18%), and melanoma in women (16%) and men (13%).

Under scenario 2, 24% of cancer deaths in males and 32% in females – or 28% overall – were avoidable.

The researchers caution that their study is limited by a high proportion of cases of unknown stage. Still, they say their findings are consistent with results from the United States indicating 15% to 25% of cancer-related deaths were potentially avoidable if tumors were detected before metastasizing.

“Given our study cohort was sourced from a population-based cancer registry with complete enumeration of cancers diagnosed during the study period, it is likely that our study findings, particularly in terms of the population rate of avoidable deaths, would be generalizable to other populations with similar characteristics,” Dr. Yu and colleagues write. “However, results may be different in countries that have a different mix of cancer types or distribution of stage at diagnosis.”

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

Catching all solid cancers before they metastasize could prevent 26% to 32% of cancer deaths in women and 18% to 24% in men within 10 years of diagnosis, researchers in Australia estimate.

Those figures translate to 2,064 to 2,677 fewer cancer deaths annually in the state of New South Wales between 2005 and 2014, the most recent period studied.

“While it is well established that diagnosing cancers at an earlier stage is ‘better,’ our study is unique in that it quantifies what that ‘better’ might look like in terms of how many deaths would be avoided within 10 years of diagnosis,” the authors write in an article published online Jan. 17 in the International Journal of Cancer. “By doing so, it is hoped that these results will provide continued motivation to develop more effective strategies to diagnose cancers at an earlier stage.”

Of course, achieving such a “stage-shift in practice is difficult,” study author Xue Qin Yu, PhD, of The Daffodil Centre in Sydney and colleagues, acknowledge. First, Dr. Yu and colleagues note, “diagnosis at an earlier stage can be challenging due to the nonspecific nature of many common symptoms which may not be recognized by either patients or doctors.” Plus, they add, a challenge for diagnosing cancers at an earlier stage “is the overall low uptake of screening.”

For their study, the researchers used data from a cohort of more than 716,000 people aged 15 to 89 years diagnosed with a solid cancer in New South Wales between 1985 and 2014 and followed through 2015.

To estimate how many deaths could be avoided if tumors were caught earlier, the authors looked at two scenarios. In scenario 1, they assumed all known cases of distant cancer were instead diagnosed at the regional stage, and in scenario 2, they assumed half of the cases were diagnosed as regional and half as localized disease.

Under the conservative scenario 1, about 18% of the observed cancer deaths in males and 26% in females could be avoided. In total, this corresponded to 21% of observed deaths.

Colorectal cancer topped the list of avoidable deaths in both men (27%) and women (33%), followed by prostate cancer in men (19%), breast cancer in women (18%), and melanoma in women (16%) and men (13%).

Under scenario 2, 24% of cancer deaths in males and 32% in females – or 28% overall – were avoidable.

The researchers caution that their study is limited by a high proportion of cases of unknown stage. Still, they say their findings are consistent with results from the United States indicating 15% to 25% of cancer-related deaths were potentially avoidable if tumors were detected before metastasizing.

“Given our study cohort was sourced from a population-based cancer registry with complete enumeration of cancers diagnosed during the study period, it is likely that our study findings, particularly in terms of the population rate of avoidable deaths, would be generalizable to other populations with similar characteristics,” Dr. Yu and colleagues write. “However, results may be different in countries that have a different mix of cancer types or distribution of stage at diagnosis.”

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

Catching all solid cancers before they metastasize could prevent 26% to 32% of cancer deaths in women and 18% to 24% in men within 10 years of diagnosis, researchers in Australia estimate.

Those figures translate to 2,064 to 2,677 fewer cancer deaths annually in the state of New South Wales between 2005 and 2014, the most recent period studied.

“While it is well established that diagnosing cancers at an earlier stage is ‘better,’ our study is unique in that it quantifies what that ‘better’ might look like in terms of how many deaths would be avoided within 10 years of diagnosis,” the authors write in an article published online Jan. 17 in the International Journal of Cancer. “By doing so, it is hoped that these results will provide continued motivation to develop more effective strategies to diagnose cancers at an earlier stage.”

Of course, achieving such a “stage-shift in practice is difficult,” study author Xue Qin Yu, PhD, of The Daffodil Centre in Sydney and colleagues, acknowledge. First, Dr. Yu and colleagues note, “diagnosis at an earlier stage can be challenging due to the nonspecific nature of many common symptoms which may not be recognized by either patients or doctors.” Plus, they add, a challenge for diagnosing cancers at an earlier stage “is the overall low uptake of screening.”

For their study, the researchers used data from a cohort of more than 716,000 people aged 15 to 89 years diagnosed with a solid cancer in New South Wales between 1985 and 2014 and followed through 2015.

To estimate how many deaths could be avoided if tumors were caught earlier, the authors looked at two scenarios. In scenario 1, they assumed all known cases of distant cancer were instead diagnosed at the regional stage, and in scenario 2, they assumed half of the cases were diagnosed as regional and half as localized disease.

Under the conservative scenario 1, about 18% of the observed cancer deaths in males and 26% in females could be avoided. In total, this corresponded to 21% of observed deaths.

Colorectal cancer topped the list of avoidable deaths in both men (27%) and women (33%), followed by prostate cancer in men (19%), breast cancer in women (18%), and melanoma in women (16%) and men (13%).

Under scenario 2, 24% of cancer deaths in males and 32% in females – or 28% overall – were avoidable.

The researchers caution that their study is limited by a high proportion of cases of unknown stage. Still, they say their findings are consistent with results from the United States indicating 15% to 25% of cancer-related deaths were potentially avoidable if tumors were detected before metastasizing.

“Given our study cohort was sourced from a population-based cancer registry with complete enumeration of cancers diagnosed during the study period, it is likely that our study findings, particularly in terms of the population rate of avoidable deaths, would be generalizable to other populations with similar characteristics,” Dr. Yu and colleagues write. “However, results may be different in countries that have a different mix of cancer types or distribution of stage at diagnosis.”

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

The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

• Helping clinicians determine whether or not to initiate opioid treatment for pain
• Opioid selection and dosage
• Duration of use and follow-up
• Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

• Helping clinicians determine whether or not to initiate opioid treatment for pain
• Opioid selection and dosage
• Duration of use and follow-up
• Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

• Helping clinicians determine whether or not to initiate opioid treatment for pain
• Opioid selection and dosage
• Duration of use and follow-up
• Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the 7-day average of daily COVID-related deaths hit 2,600 recently, the highest rate in about a year, the Washington Post reported.

That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.

The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.

“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.

The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.

The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.

The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.

“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”

CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.

The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.

“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.

In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.

The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.

Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.

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

With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the 7-day average of daily COVID-related deaths hit 2,600 recently, the highest rate in about a year, the Washington Post reported.

That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.

The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.

“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.

The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.

The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.

The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.

“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”

CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.

The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.

“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.

In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.

The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.

Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.

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

With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the 7-day average of daily COVID-related deaths hit 2,600 recently, the highest rate in about a year, the Washington Post reported.

That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.

The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.

“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.

The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.

The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.

The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.

“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”

CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.

The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.

“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.

In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.

The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.

Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.

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

A small study of deceased nonvaccinated men who died of COVID-19 complications suggests the testes may be a sanctuary for the SARS-CoV-2 virus, raising questions about potential consequences for reproductive health among those infected.

The study, published online Feb. 8 on the preprint server MedRxiv, found that “patients who become critically ill exhibit severe damages and may harbor the active virus in testes,” which can “serve as a viral sanctuary.”

Guilherme M.J. Costa, PhD, a professor at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, led the study, which has not yet been peer-reviewed.

“A critical point of this article is that the virus was active in the patient’s testis after a long period of infection, indicating that the testis is able to maintain the viable virus for extended periods. It happens for many kinds of viruses in this genital organ,” Dr. Costa said in an interview.

Brian Keith McNeil, MD, vice-chair, department of urology at SUNY Downstate Health Sciences University in New York, told this news organization that the topic of COVID-19 and fertility has been discussed but data are sparse on the subject.

“The question this raises is whether or not COVID can live in the testes, and based on this it seems it can,” he said, adding that it also raises the question of whether COVID-19 could be transmitted through semen. “It leads one to wonder whether this could have a long-term impact on fertility in men and women.”

The authors wrote that deep testicular evaluation of patients who have been infected with COVID-19 is critical because the testes have one of the highest expressions of angiotensin converting enzyme 2 (ACE2) receptors, which play a large role in entrance of the virus into cells.

“A direct influence of SARS-CoV-2 in testicular cells might deregulate ACE2, elevating the levels of angiotensin II, a potent pro-inflammatory and angiogenic peptide,” the authors wrote.
 

Sperm-producing cells infected

In 2021, the researchers enrolled 11 male patients deceased from COVID-19 complications; none had received a vaccine. Infection was confirmed by SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) performed during their hospital stay. All 11 patients were admitted to the intensive care unit with severe pulmonary symptoms.

All but one of the patients had children and none had scrotal symptoms or complaints during their time in the hospital. Their clinical histories revealed no testicular disorders.

Dr. Costa said they found that detecting SARS-CoV-2 mRNA in testes is difficult in a conventional RT-PCR test.

Therefore, “We modified the protocol of the RT-PCR and used nanosensors. We observed that SARS-CoV-2 has a huge tropism for the testes in this context,” he said.

He said the team performed stainings and “discovered that macrophages and germ cells are highly infected.”

That’s important, he said, because an immune cell, which is supposed to fight the virus, is infected in the tissue. Also, the germ cell, responsible for sperm production, is infected.

“This reopens the worries about the presence of SARS-CoV-2 in semen, as other authors mentioned,” he said.
 

New findings

The team also found that the testes are a good place for viral replication.

The authors say they are the first to show:

• The longer the severe condition, the lower the number of surviving germ cells.
• There was fluctuation in several essential testicular genes.
• The intratesticular testosterone levels are 30 times reduced in the testes of COVID-19 patients.

The control group was composed of six patients who had undergone testicle removal after prostate cancer was suspected. Collection of both testicles from the test group was performed within 3 hours of death after a family member signed an informed consent document.

Recent research on semen demonstrates that patients who recovered from COVID-19 reestablish their sperm quality after 3 months of infection.

That study, in Fertility and Sterility, found that sperm quality was initially reduced for months in some men after recovery from COVID-19.

The team studied semen samples from 120 Belgian men (mean age, 35 years) at an average 52 days after their last COVID-19 symptoms. The semen was not found to be infectious.

But among 35 men who provided samples within a month after infection, reductions in sperm motility were evident in 60% and sperm counts were reduced in 37%, according to the report.
 

Testicular damage

The results [of the Costa et al. paper] emphasize the importance of testicular damage in severe COVID-19,” Rafael Kroon Campos, PhD, a postdoctoral fellow in the department of microbiology & immunology at the University of Texas Medical Branch at Galveston, said in an interview.

He noted that other viruses have also been shown to infect or otherwise cause testicular damage or orchitis, such as Zika, Ebola, and the closely related SARS-CoV-1. Sexual transmission has been documented for Zika and Ebola viruses.

Dr. Campos said with SARS-CoV-2, it is unclear whether sexual transmission plays a role.

“Some reports found evidence of viral RNA in semen, but these were rare occurrences. The study by Costa and colleagues used a combination of sensitive techniques and they were able to detect a small amount of viral RNA and viral protein in the testicular tissue of the deceased patients, as well as show viral factories indicating replication of the virus by electron microscopy,” he said.

Dr. Campos said the findings are particularly important and concerning because of the large number of severe cases of COVID-19.

“It is critical to continue to investigate the impact of the disease in testes, including the impact of different variants of concern on testicular damage,” he said.

Dr. McNeil and Dr. Campos have disclosed no relevant financial relationships.

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

A small study of deceased nonvaccinated men who died of COVID-19 complications suggests the testes may be a sanctuary for the SARS-CoV-2 virus, raising questions about potential consequences for reproductive health among those infected.

The study, published online Feb. 8 on the preprint server MedRxiv, found that “patients who become critically ill exhibit severe damages and may harbor the active virus in testes,” which can “serve as a viral sanctuary.”

Guilherme M.J. Costa, PhD, a professor at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, led the study, which has not yet been peer-reviewed.

“A critical point of this article is that the virus was active in the patient’s testis after a long period of infection, indicating that the testis is able to maintain the viable virus for extended periods. It happens for many kinds of viruses in this genital organ,” Dr. Costa said in an interview.

Brian Keith McNeil, MD, vice-chair, department of urology at SUNY Downstate Health Sciences University in New York, told this news organization that the topic of COVID-19 and fertility has been discussed but data are sparse on the subject.

“The question this raises is whether or not COVID can live in the testes, and based on this it seems it can,” he said, adding that it also raises the question of whether COVID-19 could be transmitted through semen. “It leads one to wonder whether this could have a long-term impact on fertility in men and women.”

The authors wrote that deep testicular evaluation of patients who have been infected with COVID-19 is critical because the testes have one of the highest expressions of angiotensin converting enzyme 2 (ACE2) receptors, which play a large role in entrance of the virus into cells.

“A direct influence of SARS-CoV-2 in testicular cells might deregulate ACE2, elevating the levels of angiotensin II, a potent pro-inflammatory and angiogenic peptide,” the authors wrote.
 

Sperm-producing cells infected

In 2021, the researchers enrolled 11 male patients deceased from COVID-19 complications; none had received a vaccine. Infection was confirmed by SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) performed during their hospital stay. All 11 patients were admitted to the intensive care unit with severe pulmonary symptoms.

All but one of the patients had children and none had scrotal symptoms or complaints during their time in the hospital. Their clinical histories revealed no testicular disorders.

Dr. Costa said they found that detecting SARS-CoV-2 mRNA in testes is difficult in a conventional RT-PCR test.

Therefore, “We modified the protocol of the RT-PCR and used nanosensors. We observed that SARS-CoV-2 has a huge tropism for the testes in this context,” he said.

He said the team performed stainings and “discovered that macrophages and germ cells are highly infected.”

That’s important, he said, because an immune cell, which is supposed to fight the virus, is infected in the tissue. Also, the germ cell, responsible for sperm production, is infected.

“This reopens the worries about the presence of SARS-CoV-2 in semen, as other authors mentioned,” he said.
 

New findings

The team also found that the testes are a good place for viral replication.

The authors say they are the first to show:

• The longer the severe condition, the lower the number of surviving germ cells.
• There was fluctuation in several essential testicular genes.
• The intratesticular testosterone levels are 30 times reduced in the testes of COVID-19 patients.

The control group was composed of six patients who had undergone testicle removal after prostate cancer was suspected. Collection of both testicles from the test group was performed within 3 hours of death after a family member signed an informed consent document.

Recent research on semen demonstrates that patients who recovered from COVID-19 reestablish their sperm quality after 3 months of infection.

That study, in Fertility and Sterility, found that sperm quality was initially reduced for months in some men after recovery from COVID-19.

The team studied semen samples from 120 Belgian men (mean age, 35 years) at an average 52 days after their last COVID-19 symptoms. The semen was not found to be infectious.

But among 35 men who provided samples within a month after infection, reductions in sperm motility were evident in 60% and sperm counts were reduced in 37%, according to the report.
 

Testicular damage

The results [of the Costa et al. paper] emphasize the importance of testicular damage in severe COVID-19,” Rafael Kroon Campos, PhD, a postdoctoral fellow in the department of microbiology & immunology at the University of Texas Medical Branch at Galveston, said in an interview.

He noted that other viruses have also been shown to infect or otherwise cause testicular damage or orchitis, such as Zika, Ebola, and the closely related SARS-CoV-1. Sexual transmission has been documented for Zika and Ebola viruses.

Dr. Campos said with SARS-CoV-2, it is unclear whether sexual transmission plays a role.

“Some reports found evidence of viral RNA in semen, but these were rare occurrences. The study by Costa and colleagues used a combination of sensitive techniques and they were able to detect a small amount of viral RNA and viral protein in the testicular tissue of the deceased patients, as well as show viral factories indicating replication of the virus by electron microscopy,” he said.

Dr. Campos said the findings are particularly important and concerning because of the large number of severe cases of COVID-19.

“It is critical to continue to investigate the impact of the disease in testes, including the impact of different variants of concern on testicular damage,” he said.

Dr. McNeil and Dr. Campos have disclosed no relevant financial relationships.

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

A small study of deceased nonvaccinated men who died of COVID-19 complications suggests the testes may be a sanctuary for the SARS-CoV-2 virus, raising questions about potential consequences for reproductive health among those infected.

The study, published online Feb. 8 on the preprint server MedRxiv, found that “patients who become critically ill exhibit severe damages and may harbor the active virus in testes,” which can “serve as a viral sanctuary.”

Guilherme M.J. Costa, PhD, a professor at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, led the study, which has not yet been peer-reviewed.

“A critical point of this article is that the virus was active in the patient’s testis after a long period of infection, indicating that the testis is able to maintain the viable virus for extended periods. It happens for many kinds of viruses in this genital organ,” Dr. Costa said in an interview.

Brian Keith McNeil, MD, vice-chair, department of urology at SUNY Downstate Health Sciences University in New York, told this news organization that the topic of COVID-19 and fertility has been discussed but data are sparse on the subject.

“The question this raises is whether or not COVID can live in the testes, and based on this it seems it can,” he said, adding that it also raises the question of whether COVID-19 could be transmitted through semen. “It leads one to wonder whether this could have a long-term impact on fertility in men and women.”

The authors wrote that deep testicular evaluation of patients who have been infected with COVID-19 is critical because the testes have one of the highest expressions of angiotensin converting enzyme 2 (ACE2) receptors, which play a large role in entrance of the virus into cells.

“A direct influence of SARS-CoV-2 in testicular cells might deregulate ACE2, elevating the levels of angiotensin II, a potent pro-inflammatory and angiogenic peptide,” the authors wrote.
 

Sperm-producing cells infected

In 2021, the researchers enrolled 11 male patients deceased from COVID-19 complications; none had received a vaccine. Infection was confirmed by SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) performed during their hospital stay. All 11 patients were admitted to the intensive care unit with severe pulmonary symptoms.

All but one of the patients had children and none had scrotal symptoms or complaints during their time in the hospital. Their clinical histories revealed no testicular disorders.

Dr. Costa said they found that detecting SARS-CoV-2 mRNA in testes is difficult in a conventional RT-PCR test.

Therefore, “We modified the protocol of the RT-PCR and used nanosensors. We observed that SARS-CoV-2 has a huge tropism for the testes in this context,” he said.

He said the team performed stainings and “discovered that macrophages and germ cells are highly infected.”

That’s important, he said, because an immune cell, which is supposed to fight the virus, is infected in the tissue. Also, the germ cell, responsible for sperm production, is infected.

“This reopens the worries about the presence of SARS-CoV-2 in semen, as other authors mentioned,” he said.
 

New findings

The team also found that the testes are a good place for viral replication.

The authors say they are the first to show:

• The longer the severe condition, the lower the number of surviving germ cells.
• There was fluctuation in several essential testicular genes.
• The intratesticular testosterone levels are 30 times reduced in the testes of COVID-19 patients.

The control group was composed of six patients who had undergone testicle removal after prostate cancer was suspected. Collection of both testicles from the test group was performed within 3 hours of death after a family member signed an informed consent document.

Recent research on semen demonstrates that patients who recovered from COVID-19 reestablish their sperm quality after 3 months of infection.

That study, in Fertility and Sterility, found that sperm quality was initially reduced for months in some men after recovery from COVID-19.

The team studied semen samples from 120 Belgian men (mean age, 35 years) at an average 52 days after their last COVID-19 symptoms. The semen was not found to be infectious.

But among 35 men who provided samples within a month after infection, reductions in sperm motility were evident in 60% and sperm counts were reduced in 37%, according to the report.
 

Testicular damage

The results [of the Costa et al. paper] emphasize the importance of testicular damage in severe COVID-19,” Rafael Kroon Campos, PhD, a postdoctoral fellow in the department of microbiology & immunology at the University of Texas Medical Branch at Galveston, said in an interview.

He noted that other viruses have also been shown to infect or otherwise cause testicular damage or orchitis, such as Zika, Ebola, and the closely related SARS-CoV-1. Sexual transmission has been documented for Zika and Ebola viruses.

Dr. Campos said with SARS-CoV-2, it is unclear whether sexual transmission plays a role.

“Some reports found evidence of viral RNA in semen, but these were rare occurrences. The study by Costa and colleagues used a combination of sensitive techniques and they were able to detect a small amount of viral RNA and viral protein in the testicular tissue of the deceased patients, as well as show viral factories indicating replication of the virus by electron microscopy,” he said.

Dr. Campos said the findings are particularly important and concerning because of the large number of severe cases of COVID-19.

“It is critical to continue to investigate the impact of the disease in testes, including the impact of different variants of concern on testicular damage,” he said.

Dr. McNeil and Dr. Campos have disclosed no relevant financial relationships.

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

Ketamine is a rapid and effective treatment for suicidal ideation and has a “major” moderating effect based on the primary mental health diagnosis, results of a large randomized controlled trial show.

In addition, a strong effect of ketamine was observed in patients with bipolar disorder, “whereas the effect was moderate and did not quite reach significance in those with other psychiatric disorders and unexpectedly was nonsignificant in those with major depressive disorders,” the researchers wrote.

“We assessed for the first time in the same study the effect of ketamine on three a priori–defined groups of nonpsychotic patients: those with a bipolar disorder, those with a depressive disorder, and those with other diagnoses,” study investigator Fabrice Jollant, MD, PhD, professor of psychiatry, University of Paris, said in an interview.

“This allowed us to find that comorbid disorders are important modulators of the clinical effects of ketamine, and that the effect of ketamine is particularly marked among patients with a bipolar disorder,” Dr. Jollant added.  

The study was published online Feb. 2, 2022, in the BMJ.
 

Swift, full remission

The study included 156 adults admitted voluntarily to seven French teaching hospitals with severe suicidal ideation, including 52 with bipolar disorder, 56 with depressive disorder, and 48 with other psychiatric diagnoses.

They were randomly allocated to two 40-minute intravenous infusions of ketamine (0.5 mg/kg) or placebo (saline) administered at baseline and 24 hours, in addition to usual treatment. 

The primary outcome was the rate of patients in full suicidal remission at day 3, confirmed by a score of 3 or less on a clinician-rated scale for suicidal ideation based on 19 items scored 0-2 (maximum score, 38).

“We investigated the full remission of suicidal ideas and not only the response, which is usually defined as a reduction of 50% of scores on a given scale. If people remain slightly suicidal, the suicidal risk persists. We want all suicidal ideas to disappear,” said Dr. Jollant.

They found that more patients reached full remission of suicidal ideas at day 3 after two ketamine infusions than after placebo infusions (63% vs. 32%; odds ratio, 3.7; 95% confidence interval, 1.9-7.3; P < .001).

This antisuicidal effect of ketamine was rapid, with 44% remission only 2 hours after the first infusion, the authors reported.

The effect of ketamine on suicidal remission was greatest in patients with bipolar disorder, with 85% achieving full remission at day 3 (OR, 14.1; 95% CI, 3.0-92.2; P < .001), compared with 42% of patients with depressive disorder (OR, 1.3; 95% CI, 0.3-5.2; P = .6) or 62% of those with other disorders (OR, 3.7; 95% CI, 0.9-17.3; P = .07).

At 6 weeks after treatment, remission in the ketamine group remained high, although nonsignificantly versus placebo (69.5% vs. 56.3%; OR, 0.8; 95% CI, 0.3-2.5; P = .7).

The researchers noted the beneficial effect of ketamine on suicidal ideation could be mediated by an effect on psychological pain.

“Although mental pain does not necessarily lead to suicidal ideas, recent studies suggest that individuals with severe suicidal ideas (notably those with a plan) also have high levels of mental pain. Ketamine might therefore exert its effects through analgesic mechanisms that reduce mental pain,” they wrote.

Ketamine’s side effects were “limited” with no manic or psychotic symptoms seen. The main side effects, including sedation, denationalization/derealization, nausea, and dizziness, were of short duration and occurred in about 10% or fewer patients.

The investigators acknowledged that the nonsignificant effect of ketamine in the patients with major depressive disorders in this study is “challenging to interpret.”

They pointed out the study may have lacked power to detect an effect in these patients. In addition, this group might be particularly heterogeneous, with more patients sensitive to a placebo effect and more patients requiring repeated ketamine infusions.
 

A new perspective on ketamine

In an accompanying editorial, Riccardo De Giorgi, MD, Wellcome Trust doctoral training fellow, department of psychiatry, University of Oxford (England), said the study challenges current thinking about ketamine.

The “unexpected” outcome (no benefit) in the depressive group “perhaps defies the prevailing notion that patients with major depression would benefit most from ketamine,” Dr. De Giorgi wrote.

“In fact, both usual care and ketamine given with usual care led to low, comparable remission rates of 35.7% and 42.3% for suicidal ideation, respectively, in patients with depressive disorder,” Dr. De Giorgi pointed out.

“While this study therefore confirms that many patients with depressive disorder and suicidal ideation remain poorly served by available treatments, it shows that another important group of patients with acute suicidal ideation, those with bipolar disorder, could benefit from ketamine,” Dr. De Giorgi wrote.

“Once again, here is evidence that careful clinical evaluation must precede any consideration of ketamine use, which must be reserved for specific clinical presentations and not given indiscriminately to anyone presenting with suicidal thoughts,” he concluded.

Funding for the study was provided by Programme Hospitalier de Recherche Clinique National. Dr. Jollant and Dr. De Giorgi disclosed no relevant financial relationships.

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

Ketamine is a rapid and effective treatment for suicidal ideation and has a “major” moderating effect based on the primary mental health diagnosis, results of a large randomized controlled trial show.

In addition, a strong effect of ketamine was observed in patients with bipolar disorder, “whereas the effect was moderate and did not quite reach significance in those with other psychiatric disorders and unexpectedly was nonsignificant in those with major depressive disorders,” the researchers wrote.

“We assessed for the first time in the same study the effect of ketamine on three a priori–defined groups of nonpsychotic patients: those with a bipolar disorder, those with a depressive disorder, and those with other diagnoses,” study investigator Fabrice Jollant, MD, PhD, professor of psychiatry, University of Paris, said in an interview.

“This allowed us to find that comorbid disorders are important modulators of the clinical effects of ketamine, and that the effect of ketamine is particularly marked among patients with a bipolar disorder,” Dr. Jollant added.  

The study was published online Feb. 2, 2022, in the BMJ.
 

Swift, full remission

The study included 156 adults admitted voluntarily to seven French teaching hospitals with severe suicidal ideation, including 52 with bipolar disorder, 56 with depressive disorder, and 48 with other psychiatric diagnoses.

They were randomly allocated to two 40-minute intravenous infusions of ketamine (0.5 mg/kg) or placebo (saline) administered at baseline and 24 hours, in addition to usual treatment. 

The primary outcome was the rate of patients in full suicidal remission at day 3, confirmed by a score of 3 or less on a clinician-rated scale for suicidal ideation based on 19 items scored 0-2 (maximum score, 38).

“We investigated the full remission of suicidal ideas and not only the response, which is usually defined as a reduction of 50% of scores on a given scale. If people remain slightly suicidal, the suicidal risk persists. We want all suicidal ideas to disappear,” said Dr. Jollant.

They found that more patients reached full remission of suicidal ideas at day 3 after two ketamine infusions than after placebo infusions (63% vs. 32%; odds ratio, 3.7; 95% confidence interval, 1.9-7.3; P < .001).

This antisuicidal effect of ketamine was rapid, with 44% remission only 2 hours after the first infusion, the authors reported.

The effect of ketamine on suicidal remission was greatest in patients with bipolar disorder, with 85% achieving full remission at day 3 (OR, 14.1; 95% CI, 3.0-92.2; P < .001), compared with 42% of patients with depressive disorder (OR, 1.3; 95% CI, 0.3-5.2; P = .6) or 62% of those with other disorders (OR, 3.7; 95% CI, 0.9-17.3; P = .07).

At 6 weeks after treatment, remission in the ketamine group remained high, although nonsignificantly versus placebo (69.5% vs. 56.3%; OR, 0.8; 95% CI, 0.3-2.5; P = .7).

The researchers noted the beneficial effect of ketamine on suicidal ideation could be mediated by an effect on psychological pain.

“Although mental pain does not necessarily lead to suicidal ideas, recent studies suggest that individuals with severe suicidal ideas (notably those with a plan) also have high levels of mental pain. Ketamine might therefore exert its effects through analgesic mechanisms that reduce mental pain,” they wrote.

Ketamine’s side effects were “limited” with no manic or psychotic symptoms seen. The main side effects, including sedation, denationalization/derealization, nausea, and dizziness, were of short duration and occurred in about 10% or fewer patients.

The investigators acknowledged that the nonsignificant effect of ketamine in the patients with major depressive disorders in this study is “challenging to interpret.”

They pointed out the study may have lacked power to detect an effect in these patients. In addition, this group might be particularly heterogeneous, with more patients sensitive to a placebo effect and more patients requiring repeated ketamine infusions.
 

A new perspective on ketamine

In an accompanying editorial, Riccardo De Giorgi, MD, Wellcome Trust doctoral training fellow, department of psychiatry, University of Oxford (England), said the study challenges current thinking about ketamine.

The “unexpected” outcome (no benefit) in the depressive group “perhaps defies the prevailing notion that patients with major depression would benefit most from ketamine,” Dr. De Giorgi wrote.

“In fact, both usual care and ketamine given with usual care led to low, comparable remission rates of 35.7% and 42.3% for suicidal ideation, respectively, in patients with depressive disorder,” Dr. De Giorgi pointed out.

“While this study therefore confirms that many patients with depressive disorder and suicidal ideation remain poorly served by available treatments, it shows that another important group of patients with acute suicidal ideation, those with bipolar disorder, could benefit from ketamine,” Dr. De Giorgi wrote.

“Once again, here is evidence that careful clinical evaluation must precede any consideration of ketamine use, which must be reserved for specific clinical presentations and not given indiscriminately to anyone presenting with suicidal thoughts,” he concluded.

Funding for the study was provided by Programme Hospitalier de Recherche Clinique National. Dr. Jollant and Dr. De Giorgi disclosed no relevant financial relationships.

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

Ketamine is a rapid and effective treatment for suicidal ideation and has a “major” moderating effect based on the primary mental health diagnosis, results of a large randomized controlled trial show.

In addition, a strong effect of ketamine was observed in patients with bipolar disorder, “whereas the effect was moderate and did not quite reach significance in those with other psychiatric disorders and unexpectedly was nonsignificant in those with major depressive disorders,” the researchers wrote.

“We assessed for the first time in the same study the effect of ketamine on three a priori–defined groups of nonpsychotic patients: those with a bipolar disorder, those with a depressive disorder, and those with other diagnoses,” study investigator Fabrice Jollant, MD, PhD, professor of psychiatry, University of Paris, said in an interview.

“This allowed us to find that comorbid disorders are important modulators of the clinical effects of ketamine, and that the effect of ketamine is particularly marked among patients with a bipolar disorder,” Dr. Jollant added.  

The study was published online Feb. 2, 2022, in the BMJ.
 

Swift, full remission

The study included 156 adults admitted voluntarily to seven French teaching hospitals with severe suicidal ideation, including 52 with bipolar disorder, 56 with depressive disorder, and 48 with other psychiatric diagnoses.

They were randomly allocated to two 40-minute intravenous infusions of ketamine (0.5 mg/kg) or placebo (saline) administered at baseline and 24 hours, in addition to usual treatment. 

The primary outcome was the rate of patients in full suicidal remission at day 3, confirmed by a score of 3 or less on a clinician-rated scale for suicidal ideation based on 19 items scored 0-2 (maximum score, 38).

“We investigated the full remission of suicidal ideas and not only the response, which is usually defined as a reduction of 50% of scores on a given scale. If people remain slightly suicidal, the suicidal risk persists. We want all suicidal ideas to disappear,” said Dr. Jollant.

They found that more patients reached full remission of suicidal ideas at day 3 after two ketamine infusions than after placebo infusions (63% vs. 32%; odds ratio, 3.7; 95% confidence interval, 1.9-7.3; P < .001).

This antisuicidal effect of ketamine was rapid, with 44% remission only 2 hours after the first infusion, the authors reported.

The effect of ketamine on suicidal remission was greatest in patients with bipolar disorder, with 85% achieving full remission at day 3 (OR, 14.1; 95% CI, 3.0-92.2; P < .001), compared with 42% of patients with depressive disorder (OR, 1.3; 95% CI, 0.3-5.2; P = .6) or 62% of those with other disorders (OR, 3.7; 95% CI, 0.9-17.3; P = .07).

At 6 weeks after treatment, remission in the ketamine group remained high, although nonsignificantly versus placebo (69.5% vs. 56.3%; OR, 0.8; 95% CI, 0.3-2.5; P = .7).

The researchers noted the beneficial effect of ketamine on suicidal ideation could be mediated by an effect on psychological pain.

“Although mental pain does not necessarily lead to suicidal ideas, recent studies suggest that individuals with severe suicidal ideas (notably those with a plan) also have high levels of mental pain. Ketamine might therefore exert its effects through analgesic mechanisms that reduce mental pain,” they wrote.

Ketamine’s side effects were “limited” with no manic or psychotic symptoms seen. The main side effects, including sedation, denationalization/derealization, nausea, and dizziness, were of short duration and occurred in about 10% or fewer patients.

The investigators acknowledged that the nonsignificant effect of ketamine in the patients with major depressive disorders in this study is “challenging to interpret.”

They pointed out the study may have lacked power to detect an effect in these patients. In addition, this group might be particularly heterogeneous, with more patients sensitive to a placebo effect and more patients requiring repeated ketamine infusions.
 

A new perspective on ketamine

In an accompanying editorial, Riccardo De Giorgi, MD, Wellcome Trust doctoral training fellow, department of psychiatry, University of Oxford (England), said the study challenges current thinking about ketamine.

The “unexpected” outcome (no benefit) in the depressive group “perhaps defies the prevailing notion that patients with major depression would benefit most from ketamine,” Dr. De Giorgi wrote.

“In fact, both usual care and ketamine given with usual care led to low, comparable remission rates of 35.7% and 42.3% for suicidal ideation, respectively, in patients with depressive disorder,” Dr. De Giorgi pointed out.

“While this study therefore confirms that many patients with depressive disorder and suicidal ideation remain poorly served by available treatments, it shows that another important group of patients with acute suicidal ideation, those with bipolar disorder, could benefit from ketamine,” Dr. De Giorgi wrote.

“Once again, here is evidence that careful clinical evaluation must precede any consideration of ketamine use, which must be reserved for specific clinical presentations and not given indiscriminately to anyone presenting with suicidal thoughts,” he concluded.

Funding for the study was provided by Programme Hospitalier de Recherche Clinique National. Dr. Jollant and Dr. De Giorgi disclosed no relevant financial relationships.

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