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Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

Despite Spain’s lack of a national project or standard protocol for biomarker testing, more than half of patients diagnosed with stage 4 non–small cell lung cancer (NSCLC) are tested for biomarkers, according to a Spanish national registry study reported at the 2022 European Lung Cancer Congress.

“In recent years we’ve developed drugs that target biomarkers, so it’s important to identify those biomarkers to guide treatment and have an impact on the survival of our patients,” said lead author Virginia Calvo, MD, a medical oncologist with the Puerta de Hierro Majadahonda University Hospital, Madrid.

“If we don’t know our patients’ biomarkers, we can’t treat them with targeted therapies,” she added, noting that the overall survival of lung cancer patients has increased by 15% in the last 10 years, largely because of better therapies such as targeted drugs for advanced stage disease and immunotherapies.

To assess the status of biomarker testing in Spain, Dr. Calvo and colleagues analyzed data from the country’s Thoracic Tumor Registry on 9,239 patients diagnosed with metastatic NSCLC from 2016 to the present, 7,467 (81%) with nonsquamous tumors and 1,772 (19%) with squamous tumors.

They found that 85% of patients with nonsquamous NSCLC and about 53% of those with squamous cancers had undergone biomarker testing. They discovered that 4,115 (44%) of patients tested positive for EGFR, ALK, KRAS, BRAF, ROS1, or PD-L1.

Dr. Calvo attributes the widespread use of biomarker testing and its significant increase in the last 5 years to the growing knowledge and understanding of the disease.

“We are learning more about NSCLC, and I think in the next few years the number of biomarkers are going to grow,” she said.

The study’s findings also highlight the importance of establishing and maintaining cancer registries, Dr. Calvo said, noting that 182 hospitals across Spain and more than 550 experts participate in the Thoracic Tumors Registry, which includes data on patients from every Spanish territory.

“It’s important to collect information on real-life cancer care so that we know what our real situation is and take steps to improve it,” she said.

She anticipates that treatment for NSCLC patients will become increasingly complex in the future with the growing number of different biomarkers and the proportion of patients who test positive for them. “We may need to establish national strategies to implement next generation sequencing so that we can identify different biomarkers and improve the survival of our patients.”

In a press release, Rolf Stahel, MD, president of the European Thoracic Oncology Platform, said that it would be helpful to look at how frequently molecular testing led to patients receiving appropriate targeted treatment.

In the United States, the National Comprehensive Cancer Network recommends biomarker testing for eligible patients with newly diagnosed stage 4 NSCLC, and it can be considered for patients with squamous histology because 5%-10% of these tumors have targetable mutations. “This is because numerous lines of evidence show that patients with stage 4 NSCLC and a targetable mutation, typically have improved overall survival when treated with a targeted therapy,” wrote the authors of the NCCN recommendations.

“For newly diagnosed stage 4 NSCLC, there is always a tension between the need to start therapy versus waiting for molecular results. This is because if a recommended targeted option is identified, it is the optimal first-line therapy. Targeted therapy cannot be given to everyone. Different biomarkers predict response to different agents. This has been well illustrated and it makes testing critically important for patients with NSCLC,” Dara Aisner, MD, PhD, associate professor of pathology with the University of Colorado at Denver, Aurora, wrote in the NCCN guideline.

The study presented at ELCC was funded by a grant from the European Union’s Horizon 2020 Research and Innovation Program. Dr. Calvo has received fees from Roche, Bristol-Myers Squibb, MSD and AstraZeneca.

Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

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

Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

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

Can’t sleep? When slumber doesn’t come naturally, some are turning to melatonin, an over-the-counter sleep aid that often is mistaken for a supplement. This powerful hormone plays an important role in human biology, and specialists are questioning whether increasing levels could be doing more harm than good.

A new investigation launched by the American Academy of Sleep Medicine is looking into the safety of melatonin. And while the health advisory checking the evidence is underway, the academy is recommending that melatonin not be used for insomnia in adults or children.

But what is insomnia, and how is it different from a few bad nights of sleep? Insomnia disturbs sleep at least three times a week for more than 3 months, often causing people to feel tired during the day as well.

Production of melatonin (dubbed the “vampire hormone”) begins at night, when it starts getting dark outside. Melatonin release is scheduled by the small but mighty pineal gland at the back of the head. Melatonin signals to the body that it’s time to sleep. And as the sun rises and light shines, melatonin levels decline again to help the body wake.

Sometimes packaged in gummy bear fruit flavors, melatonin can have an alluring appeal to sleep-deprived parents looking for relief for themselves and their children.

Muhammad Adeel Rishi, MD, vice chair of the public safety committee for the American Academy of Sleep Medicine, said he has a doctor colleague who started taking melatonin to help him during the pandemic when he was having trouble falling asleep at night. His doctor friend started giving the hormone to his own children, who were also having sleep issues.

But Dr. Rishi said there are important reasons to not use melatonin for insomnia until more information is available.

Melatonin affects sleep, but this hormone also influences other functions in the body. “It has an impact on body temperature, blood sugar, and even the tone of blood vessels,” Dr. Rishi said.

And because melatonin is available over the counter in the United States, it hasn’t been approved as a medicine under the Food and Drug Administration. A previous study of melatonin products, for instance, flagged problems with inconsistent doses, which make it hard for people to know exactly how much they are getting and prompted calls for more FDA oversight.
 

Imprecise doses

While melatonin doses typically range from 1 to 5 milligrams, bottles examined have been off target with much more or less hormone in the product than listed on the label.

Researchers from the University of Guelph (Ont.), tested 30 commercially available formulas and found the melatonin content varied from the ingredients labeled on the bottles by more than 10%. In addition to melatonin, the researchers found other substances in the bottles too: In about a quarter of the products, they also identified serotonin.
 

Impurities

While melatonin plays a role in setting the body’s biological clock and the sleep and wake cycle, serotonin is also at work. Occurring naturally in our bodies, serotonin is involved in mood and helps with deep REM sleep. But adding serotonin in unknown amounts could be unhealthy.

Dr. Rishi said it can be dangerous to use a product as a medication when doses can be so off and there are unknown byproducts in it.

Serotonin can influence the heart, blood vessels, and brain, so it’s not something Dr. Rishi wants to see people taking without paying attention. People taking medication for mood disorders could be especially affected by the serotonin in their sleep aid, he warns.

For anyone taking melatonin, Dr. Rishi recommended they check the bottle to see whether they are using a product with a USP-verified check mark, which indicates that the product meets the standards of the U.S. Pharmacopeia Convention.

The risk of impurities is a good reason for kids to not be given the hormone, but another worry is whether melatonin interferes with puberty in children – which is also a question researchers at the Children’s Hospital of Eastern Ontario in Ottawa are asking.
 

Disrupting puberty

While short-term melatonin use is considered safe, the researchers reported, concerns that long-term use might delay children’s sexual maturation require more study. One theory is that nightly melatonin use might interrupt the decline of natural hormone levels and interfere with the start of puberty.

Researchers from the Children’s Hospital of Michigan in Detroit also reported an uptick in accidental ingestion of melatonin in children. Kids got their hands on melatonin and swallowed too many capsules more often than other pill-related mishaps during the pandemic.

Dr. Rishi said more research is needed to assess the safe use of melatonin in children. He points out that the hormone can treat circadian rhythm disorders in adults.

While specialists weigh the benefits and risks of melatonin use and where it is safest to try, Dr. Rishi said the hormone does have a role in medicine.

Melatonin will probably need to be regulated by the FDA as a medication – especially for children – Dr. Rishi pointed out. And what place, if any, it will have for managing chronic insomnia is “a big question mark.”

Results of the investigation by the American Academy of Sleep Medicine will be published on its sleepeducation.org website in a few months.

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

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

A pair of new studies offers more evidence for the value of vegetables and the risk of red meat on the cancer prevention front. Researchers report that high consumption of vegetables – especially lettuce, legumes, and cruciferous varieties – appears to lower the risk of liver cancer/liver disease. A separate team suggests that high consumption of red meat, organ meats, and processed meats boosts the risk of gastric cancer.

The findings of the latter study “reinforce the idea that avoidance of red meat and processed meat is probably good beyond [the prevention of] colorectal cancer,” said corresponding author and epidemiologist Paolo Boffetta, MD, MPH, of Stony Brook University Cancer Center, New York, in an interview. “The possible carcinogenic effect may extend beyond the colon.”

Both studies were released at the annual meeting of the American Association for Cancer Research.

For the red meat study, researchers examined statistics from the Golestan cohort study, which is prospectively tracking 50,045 people aged 40-75 from northeastern Iran. The study focuses on esophageal cancer due to the region’s high rate of the disease.

Red meat consumption is fairly rare in the region, where residents typically prefer chicken, said study lead author Giulia Collatuzzo, MD, a resident physician in occupational medicine at the University of Bologna, Italy, in an interview. On average, participants reported eating 18.4 grams daily of red meat and 72.1 grams daily of white meat.

The researchers tracked study participants for a median 12-year follow-up, during which 369 developed esophageal cancer and 368 developed gastric cancer. Red meat was only linked to more esophageal cancer in women (hazard ratio, 1.13, 95% confidence interval, 1.00-1.18, for each quintile increase in consumption).

Overall red meat consumption (including red meat, organ meat, and processed meat) was linked to higher rates of gastric cancer (HR, 1.08, 95% CI, 1.00-1.17) for each quartile increase in consumption, as was consumption of the red meat subtype alone (HR, 1.09, 95% CI, 1.00-1.18).

According to Dr. Collatuzzo, the findings suggest that those in the highest quartile of overall red meat consumption may have around a 25% increase in risk, compared with the lowest quartile.

Overall, she said, the study findings aren’t surprising. The lack of a connection between red meat consumption and esophageal cancer may be due to the fact that meat only temporarily transits through the esophagus, she said.

For the liver cancer/liver disease study, researchers examined the medical records of 470,653 subjects in the NIH-AARP Diet and Health Study. They were recruited in 1995-1996 when they were 50-71 years old. Over a median follow-up of 15.5 years, 899 developed liver cancer, and 934 died of chronic liver disease.

The median intakes of vegetables in quintile 5 (highest) and quintile 1 (lowest) were 3.7 cups daily and 1.0 cups daily, respectively, said study lead author Long-Gang Zhao, MS, a graduate student at Harvard University.

After adjusting for possible cofounders, those in the highest quintile of vegetable consumption were a third less likely to develop liver cancer, compared with the lowest quintile (HR, 0.66, 95% CI, 0.53-0.82, P < 0.01). Several types of vegetables appeared to be the strongest cancer fighters: cruciferous (broccoli, cauliflower), lettuce, legumes, and carrots. These kinds of vegetables were also linked to lower rates of chronic liver disease mortality (all P < 0.01), as was total vegetable intake for the top quintile versus the lowest quintile (HR, 0.60, 95% CI, 0.49-0.74, P = < 0.01).

“A one-cup increase (8 oz or 225 g) in vegetable intake was associated with about 20% decreased risk of liver cancer incidence and chronic liver mortality,” Zhao said.

There was no statistically significant link between fruit consumption and liver cancer or chronic liver disease mortality.

The findings provide more insight into diet and liver disease, Zhao said. “Chronic liver disease, which predisposes to liver cancer, is the tenth cause of death worldwide, causing two million deaths each year. It shares some etiological processes with liver cancer. Therefore, examining both chronic liver disease mortality and liver cancer incidence in our study may provide a more general picture for the prevention of liver diseases.”

As for limitations, both studies are based on self-reports about food consumption, which can be unreliable, and the subjects in the fruit/vegetable analysis were mainly of European origin.

The authors of both studies report no relevant disclosures. No funding is reported for either study.

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

With New York nurse practitioners recently gaining full practice authority (FPA), half of the country’s NPs now have the ability to provide patients with easier access to care, according to leading national nurse organizations.

New York joins 24 other states, the District of Columbia, and two U.S. territories that have adopted FPA legislation, as reported by the American Association of Nurse Practitioners (AANP). Like other states, New York has been under an emergency order during the pandemic that allowed NPs to practice to their full authority because of staffing shortages. That order was extended multiple times and was expected to expire this month, AANP reports.

“This has been in the making for nurse practitioners in New York since 2014, trying to get full practice authority,” Michelle Jones, RN, MSN, ANP-C, director at large for the New York State Nurses Association, said in an interview.

NPs who were allowed to practice independently during the pandemic campaigned for that provision to become permanent once the emergency order expired, she said. Ms. Jones explained that the FPA law expands the scope of practice and “removes unnecessary barriers,” namely an agreement with doctors to oversee NPs’ actions.

FPA gives NPs the authority to evaluate patients; diagnose, order, and interpret diagnostic tests; and initiate and manage treatments – including prescribing medications – without oversight by a doctor or state medical board, according to AANP.

Before the pandemic, New York NPs had “reduced” practice authority with those who had more than 3,600 hours of experience required to maintain a collaborative practice agreement with doctors and those with less experience maintaining a written agreement. The change gives full practice authority to those with more than 3,600 hours of experience, Stephen A. Ferrara, DNP, FNP-BC, AANP regional director, said in an interview.

Ferrara, who practices in New York, said the state is the largest to change to FPA. He said the state and others that have moved to FPA have determined that there “has been no lapse in quality care” during the emergency order period and that the regulatory barriers kept NPs from providing access to care.

Jones said that the law also will allow NPs to open private practices and serve underserved patients in areas that lack access to health care. “This is a step to improve access to health care and health equity of the New York population.”

It’s been a while since another state passed FPA legislation, Massachusetts in January 2021 and Delaware in August 2021, according to AANP.

Earlier this month, AANP released new data showing a 9% increase in NPs licensed to practice in the United States, rising from 325,000 in May 2021 to 355,000.

The New York legislation “will help New York attract and retain nurse practitioners and provide New Yorkers better access to quality care,” AANP President April Kapu, DNP, APRN, said in a statement.

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

The war in Ukraine is resulting in a devastating loss of life, catastrophic injuries, and physical destruction. But the war also will take an enormous mental health toll on millions of people, resulting in what I think will lead to an epidemic of posttraumatic stress disorder.

Think about the horrors that Ukrainians are experiencing. Millions of Ukrainians have been displaced to locations inside and outside of the country. People are being forced to leave behind family members, neighbors, and their pets and homes. In one recent news report, a Ukrainian woman who left Kyiv for Belgium reported having dreams in which she heard explosions. Smells, sounds, and even colors can trigger intrusive memories and a host of other problems. The mind can barely comprehend the scope of this human crisis.

Ukrainian soldiers are witnessing horrors that are unspeakable. Doctors, emergency service workers, and other medical professionals in Ukraine are being exposed to the catastrophe on a large scale. Children and youth are among the most affected victims, and it is difficult to predict the impact all of this upheaval is having on them.

The most important question for those of us who treat mental illness is “how will we help devastated people suffering from extreme trauma tied to death, dying, severe injuries, and torture by the invading soldiers?”

I have been treating patients with PTSD for many years. In my lifetime, the devastation in Ukraine will translate into what I expect will be the first overwhelming mass epidemic of PTSD – at least that I can recall. Yes, surely PTSD occurred during and after the Holocaust in the World War II era, but at that time, the mental health profession was not equipped to recognize it – even though the disorder most certainly existed. Even in ancient times, an Assyrian text from Mesopotamia (currently Iraq) described what we would define as PTSD symptoms in soldiers, such as sleep disturbances, flashbacks, and “low mood,” according to a 2014 article in the journal Early Science and Medicine.

The DSM-5 describes numerous criteria for PTSD mainly centering on trauma exposing a person to actual or threatened death, serious injury, or a variety of assaults, including direct exposure or witnessing the event. However, in my clinical experience, I’ve seen lesser events leading to PTSD. Much depends on how each individual processes what is occurring or has occurred.

What appears to be clear is that some key aspects of PTSD according to the DSM-5 – such as trauma-related thoughts or feelings, or trauma-related reminders, as well as nightmares and flashbacks – are likely occurring among Ukrainians. In addition, hypervigilance and exaggerated startle response seem to be key components of PTSD whether or not the cause is a major event or what one would perceive as less traumatic or dramatic.

I’ve certainly seen PTSD secondary to a hospitalization, especially in care involving ICUs or cardiac care units. In addition, I’ve had the occasion to note PTSD signs and symptoms after financial loss or divorce, situations in which some clinicians would never believe PTSD would occur, and would often diagnose as anxiety or depression. For me, again from a clinical point of view, it’s always been critical to assess how individuals process the event or events around them.

We know that there is already a shortage of mental health clinicians across the globe. This means that, in light of the hundreds of thousands – possibly millions – of Ukrainians affected by PTSD, a one-to-one approach will not do. For those Ukrainians who are able to find safe havens, I believe that organized medicine, including the various psychiatric/psychological associations in Europe as well as the American Psychiatric Association and the American Psychological Association, need to establish group care using telemedicine to reach large numbers of people. PTSD symptoms can be debilitating, and the mental health community needs to begin putting supports in place now to address this trauma.

Specifically, proven cognitive-behavioral therapy (CBT) and guided imagery should be used to begin helping some of these people recover from the unbelievable trauma of war. For some, medication management might be helpful in those experiencing nightmares combined with anxiety and depression. But the main approach and first line of care should be CBT and guided imagery.

PTSD symptoms can make people feel like they are losing control, and prevent them from rebuilding their lives. We must do all we can in the mental health community to destigmatize care and develop support services to get ahead of this crisis. Only through medical, psychiatric, and health care organizations banding together using modern technology can the large number of people psychologically affected by this ongoing crisis be helped and saved.
 

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

The war in Ukraine is resulting in a devastating loss of life, catastrophic injuries, and physical destruction. But the war also will take an enormous mental health toll on millions of people, resulting in what I think will lead to an epidemic of posttraumatic stress disorder.

Think about the horrors that Ukrainians are experiencing. Millions of Ukrainians have been displaced to locations inside and outside of the country. People are being forced to leave behind family members, neighbors, and their pets and homes. In one recent news report, a Ukrainian woman who left Kyiv for Belgium reported having dreams in which she heard explosions. Smells, sounds, and even colors can trigger intrusive memories and a host of other problems. The mind can barely comprehend the scope of this human crisis.

Ukrainian soldiers are witnessing horrors that are unspeakable. Doctors, emergency service workers, and other medical professionals in Ukraine are being exposed to the catastrophe on a large scale. Children and youth are among the most affected victims, and it is difficult to predict the impact all of this upheaval is having on them.

The most important question for those of us who treat mental illness is “how will we help devastated people suffering from extreme trauma tied to death, dying, severe injuries, and torture by the invading soldiers?”

I have been treating patients with PTSD for many years. In my lifetime, the devastation in Ukraine will translate into what I expect will be the first overwhelming mass epidemic of PTSD – at least that I can recall. Yes, surely PTSD occurred during and after the Holocaust in the World War II era, but at that time, the mental health profession was not equipped to recognize it – even though the disorder most certainly existed. Even in ancient times, an Assyrian text from Mesopotamia (currently Iraq) described what we would define as PTSD symptoms in soldiers, such as sleep disturbances, flashbacks, and “low mood,” according to a 2014 article in the journal Early Science and Medicine.

The DSM-5 describes numerous criteria for PTSD mainly centering on trauma exposing a person to actual or threatened death, serious injury, or a variety of assaults, including direct exposure or witnessing the event. However, in my clinical experience, I’ve seen lesser events leading to PTSD. Much depends on how each individual processes what is occurring or has occurred.

What appears to be clear is that some key aspects of PTSD according to the DSM-5 – such as trauma-related thoughts or feelings, or trauma-related reminders, as well as nightmares and flashbacks – are likely occurring among Ukrainians. In addition, hypervigilance and exaggerated startle response seem to be key components of PTSD whether or not the cause is a major event or what one would perceive as less traumatic or dramatic.

I’ve certainly seen PTSD secondary to a hospitalization, especially in care involving ICUs or cardiac care units. In addition, I’ve had the occasion to note PTSD signs and symptoms after financial loss or divorce, situations in which some clinicians would never believe PTSD would occur, and would often diagnose as anxiety or depression. For me, again from a clinical point of view, it’s always been critical to assess how individuals process the event or events around them.

We know that there is already a shortage of mental health clinicians across the globe. This means that, in light of the hundreds of thousands – possibly millions – of Ukrainians affected by PTSD, a one-to-one approach will not do. For those Ukrainians who are able to find safe havens, I believe that organized medicine, including the various psychiatric/psychological associations in Europe as well as the American Psychiatric Association and the American Psychological Association, need to establish group care using telemedicine to reach large numbers of people. PTSD symptoms can be debilitating, and the mental health community needs to begin putting supports in place now to address this trauma.

Specifically, proven cognitive-behavioral therapy (CBT) and guided imagery should be used to begin helping some of these people recover from the unbelievable trauma of war. For some, medication management might be helpful in those experiencing nightmares combined with anxiety and depression. But the main approach and first line of care should be CBT and guided imagery.

PTSD symptoms can make people feel like they are losing control, and prevent them from rebuilding their lives. We must do all we can in the mental health community to destigmatize care and develop support services to get ahead of this crisis. Only through medical, psychiatric, and health care organizations banding together using modern technology can the large number of people psychologically affected by this ongoing crisis be helped and saved.
 

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

The war in Ukraine is resulting in a devastating loss of life, catastrophic injuries, and physical destruction. But the war also will take an enormous mental health toll on millions of people, resulting in what I think will lead to an epidemic of posttraumatic stress disorder.

Think about the horrors that Ukrainians are experiencing. Millions of Ukrainians have been displaced to locations inside and outside of the country. People are being forced to leave behind family members, neighbors, and their pets and homes. In one recent news report, a Ukrainian woman who left Kyiv for Belgium reported having dreams in which she heard explosions. Smells, sounds, and even colors can trigger intrusive memories and a host of other problems. The mind can barely comprehend the scope of this human crisis.

Ukrainian soldiers are witnessing horrors that are unspeakable. Doctors, emergency service workers, and other medical professionals in Ukraine are being exposed to the catastrophe on a large scale. Children and youth are among the most affected victims, and it is difficult to predict the impact all of this upheaval is having on them.

The most important question for those of us who treat mental illness is “how will we help devastated people suffering from extreme trauma tied to death, dying, severe injuries, and torture by the invading soldiers?”

I have been treating patients with PTSD for many years. In my lifetime, the devastation in Ukraine will translate into what I expect will be the first overwhelming mass epidemic of PTSD – at least that I can recall. Yes, surely PTSD occurred during and after the Holocaust in the World War II era, but at that time, the mental health profession was not equipped to recognize it – even though the disorder most certainly existed. Even in ancient times, an Assyrian text from Mesopotamia (currently Iraq) described what we would define as PTSD symptoms in soldiers, such as sleep disturbances, flashbacks, and “low mood,” according to a 2014 article in the journal Early Science and Medicine.

The DSM-5 describes numerous criteria for PTSD mainly centering on trauma exposing a person to actual or threatened death, serious injury, or a variety of assaults, including direct exposure or witnessing the event. However, in my clinical experience, I’ve seen lesser events leading to PTSD. Much depends on how each individual processes what is occurring or has occurred.

What appears to be clear is that some key aspects of PTSD according to the DSM-5 – such as trauma-related thoughts or feelings, or trauma-related reminders, as well as nightmares and flashbacks – are likely occurring among Ukrainians. In addition, hypervigilance and exaggerated startle response seem to be key components of PTSD whether or not the cause is a major event or what one would perceive as less traumatic or dramatic.

I’ve certainly seen PTSD secondary to a hospitalization, especially in care involving ICUs or cardiac care units. In addition, I’ve had the occasion to note PTSD signs and symptoms after financial loss or divorce, situations in which some clinicians would never believe PTSD would occur, and would often diagnose as anxiety or depression. For me, again from a clinical point of view, it’s always been critical to assess how individuals process the event or events around them.

We know that there is already a shortage of mental health clinicians across the globe. This means that, in light of the hundreds of thousands – possibly millions – of Ukrainians affected by PTSD, a one-to-one approach will not do. For those Ukrainians who are able to find safe havens, I believe that organized medicine, including the various psychiatric/psychological associations in Europe as well as the American Psychiatric Association and the American Psychological Association, need to establish group care using telemedicine to reach large numbers of people. PTSD symptoms can be debilitating, and the mental health community needs to begin putting supports in place now to address this trauma.

Specifically, proven cognitive-behavioral therapy (CBT) and guided imagery should be used to begin helping some of these people recover from the unbelievable trauma of war. For some, medication management might be helpful in those experiencing nightmares combined with anxiety and depression. But the main approach and first line of care should be CBT and guided imagery.

PTSD symptoms can make people feel like they are losing control, and prevent them from rebuilding their lives. We must do all we can in the mental health community to destigmatize care and develop support services to get ahead of this crisis. Only through medical, psychiatric, and health care organizations banding together using modern technology can the large number of people psychologically affected by this ongoing crisis be helped and saved.
 

Dr. London is a practicing psychiatrist who has been a newspaper columnist for 35 years, specializing in writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (New York: Kettlehole Publishing, 2019). He has no conflicts of interest.

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

New research suggests that chemotherapy treatments for recurrent high-grade gliomas indicated by an assay-guided tool called ChemoID can boost median survival, compared with physician choice.

The randomized, phase 3 trial results were presented at the annual meeting of the American Association for Cancer Research.

Over a median follow-up of 9 months, median overall survival in the ChemoID group was 12.5 months (95% confidence interval, 10.2-14.7), compared with 9 months (95% CI, 4.2-13.8) in the group whose treatments were chosen by physicians (P = .010).

“While the prognosis is very dismal, we’re still providing a 3.5-month benefit in the guided arm versus physician choice,” said study coauthor Jagan Valluri, PhD, professor of cellular biology and integrative medicine at Marshall University, Huntington, W. Va.

As Dr. Valluri noted, patients with recurrent high-grade gliomas typically have failed radiation and are left with poor prognoses. Fewer than one in four patients respond to chemotherapy at this point, he said, and the response is inconsistent from patient to patient.

“We developed ChemoID since cancer is very unique,” he said, “and any kind of chemotherapy should be tailored to each individual patient on a case-by-case basis.”

The ChemoID tool, a proprietary assay, tests the response of patient cells to various chemotherapy treatments. A test costs $3,500, and some insurers cover it, Dr. Valluri said.

For the new study, researchers randomly assigned 50 patients with grade III/IV recurrent glioma to be treated with chemotherapy chosen by physicians or chemotherapy recommended by the ChemoID tool.

Risk of death in the ChemoID group was lower than in the physician-guided group (hazard ratio, 0.44; 95% CI, 0.24-0.81; P = .008), and median progression-free survival was higher in the ChemoID group (10.1 months vs. 3.5 months; 95% CI, 4.8-15.4 vs. 1.9-5.1; HR, 0.25; 95% CI, 0.14-0.44; P < .001).

“We want the treating physician to have actionable tools in front of them before they treat the patient,” Dr. Valluri said. “We want this assay to become mainstream and part of the standard care workup.”

The study is funded by Cordgenics, where Dr. Valluri serves as chief operating officer.

Clinicians are not following guidelines that recommend a de-escalation in surveillance for patients with low-risk non–muscle-invasive bladder cancer (NMIBC), a new study concludes.  

These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.

However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.

“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.

The study was published online in JAMA Network Open.
 

Higher value and more evidence-based

The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.

“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.

“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.

Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.

“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
 

Study finds frequent surveillance

The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.

However, the new study found that in practice, such patients undergo frequent testing.

The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).

Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.

The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.

Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.

As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.

When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).

The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.

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

Clinicians are not following guidelines that recommend a de-escalation in surveillance for patients with low-risk non–muscle-invasive bladder cancer (NMIBC), a new study concludes.  

These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.

However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.

“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.

The study was published online in JAMA Network Open.
 

Higher value and more evidence-based

The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.

“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.

“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.

Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.

“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
 

Study finds frequent surveillance

The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.

However, the new study found that in practice, such patients undergo frequent testing.

The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).

Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.

The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.

Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.

As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.

When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).

The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.

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

Clinicians are not following guidelines that recommend a de-escalation in surveillance for patients with low-risk non–muscle-invasive bladder cancer (NMIBC), a new study concludes.  

These cancers are associated with low rates of recurrence, progression, and bladder cancer–specific death, so current clinical practice guidelines recommend against frequent monitoring and testing.

However, the study authors found that patients with a low grade Ta NMIBC diagnosis underwent a median of three cystoscopies per year, and many also received a median of two imagine scans (CT or MRI) as well as 2-3 urine-based tests.

“These data suggest a need for ongoing efforts to limit overuse of treatment and surveillance, which may in turn mitigate associated increases in the costs of care,” write the authors, led by Kelly K. Bree, MD, from the department of urology, University of Texas MD Anderson Cancer Center, Houston. Bladder cancer has the highest lifetime treatment cost of all malignancies, they point out.

The study was published online in JAMA Network Open.
 

Higher value and more evidence-based

The impact of increased surveillance of this patient cohort has broad implications for patients and the health care system in general, say experts writing in an accompanying editorial.

“It has been well established that workup for NMIBC can have negative consequences for the physical and psychological health of patients,” note Grayden S. Cook, BS, and Jeffrey M. Howard, MD, PhD, both from University of Texas Southwestern Medical Center, Dallas.

“Many of these patients undergo frequent CT imaging of the urinary tract, which carries a high dose of radiation as well as the potential for financial toxic effects (that is, detrimental consequences to the patient because of health care costs),” they write.

Additionally, patient distress is a factor, as they may experience preprocedural anxiety, physical discomfort during procedures, and worry about disease progression, they point out.

“The impact of these patterns is substantial and may have negative consequences for both patients and the health care system,” they conclude. “Thus, it is imperative to move forward with initiatives that provide higher value and are more evidence-based and patient-centered.”
 

Study finds frequent surveillance

The American Urological Association (AUA)/Society of Urologic Oncologists (SUO), the European Association of Urology, and the International Bladder Cancer Group have made an effort to de-escalate surveillance and treatment for patients with low-grade Ta disease, while at the same time maintaining appropriate surveillance for high-grade aggressive disease.

However, the new study found that in practice, such patients undergo frequent testing.

The study involved 13,054 patients with low-grade Ta NMIBC. Most of the participants were male (73.5%), with a median age of 76 years, and had no or few comorbidities (71.2%).

Most patients had undergone cystoscopy, and rates increased over time: from 79.3% of patients in 2004 to 81.5% of patients in 2013 (P = .007). Patients underwent a median of 3.0 cystoscopies per year following their diagnosis, and upper-tract imaging was performed in most patients.

The use of kidney ultrasonography also rose from 19% of patients in 2004 to 23.2% in 2013, as did retrograde pyelography (20.9% in 2004 vs. 24.2% in 2013). Conversely, the use of intravenous pyelography declined (from 14.5% in 2004 to 1.7% in 2012), but there was an increase in CT and MRI in all years except 2010 (from 30.4% of patients in 2004 to 47% of patients in 2013; P < .001). The rate of urine-based testing also significantly increased during the study period (from 44.8% in 2004 to 54.9% in 2013; P < .001), with patients undergoing between two to three tests per year.

Adherence to current guidelines remained similar during the study time frame. For example, 55.2% of patients received two cystoscopies per year in 2004-2008, compared with 53.8% in 2009-2013 (P = .11), suggesting that there was an overuse of all surveillance testing modalities.

As for treatment, 17.2% received intravesical immunotherapy with bacillus Calmette-Guérin, 6.1% were treated with intravesical chemotherapy (excluding receipt of a single perioperative dose). Disease recurrence within this cohort was 1.7%, and only 0.4% experienced disease progression.

When looking at the cost, the total median expenditures at 1 year after diagnosis increased by 60% during the study period, from $34,792 in 2004 to $53,986 in 2013. Higher costs were seen among patients who experienced a recurrence versus no recurrence ($76,669 vs. $53,909).

The study was supported by a grant from the U.S. Department of Defense Peer Reviewed Cancer Research Program. Several of the authors have disclosed relationships with industry, as noted in the original article. Editorialists Mr. Cook and Dr. Howard have disclosed no relevant financial relationships.

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

The addition of aspirin to standard guideline management for blood pressure did not reduce the risk of cardiovascular events among adults with hypertension and controlled systolic blood pressure in a study.

The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.

In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.

The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.

“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.

The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.

The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.

In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.

An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.

The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.

Findings confirm value of preventive care

“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.

Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.

As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”

Data support shared decision-making

“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”

“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized. 

Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.

Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.

The addition of aspirin to standard guideline management for blood pressure did not reduce the risk of cardiovascular events among adults with hypertension and controlled systolic blood pressure in a study.

The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.

In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.

The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.

“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.

The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.

The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.

In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.

An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.

The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.

Findings confirm value of preventive care

“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.

Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.

As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”

Data support shared decision-making

“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”

“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized. 

Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.

Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.

The addition of aspirin to standard guideline management for blood pressure did not reduce the risk of cardiovascular events among adults with hypertension and controlled systolic blood pressure in a study.

The benefits of aspirin use for the primary prevention of atherosclerotic cardiovascular disease (ASCVD) have been questioned in light of data showing neutral outcomes in low-risk patients and concerns about increased bleeding risk and mortality in healthy older adults, wrote Rita Del Pinto, MD, of University of L’Aquila (Italy) and colleagues in JAMA Network Open.

In the study, Dr. Del Pinto and colleagues conducted a post hoc analysis of data from more than 2,500 participants in SPRINT (Systolic Blood Pressure Intervention Trial), a multicenter, randomized trial conducted from 2010 to 2013.

The goal of SPRINT was to compare intensive and standard blood pressure–lowering strategies for hypertension patients. The primary outcome of the current study was risk of a first cardiovascular event, which included adjudicated myocardial infarction, non–myocardial infarction acute coronary syndrome, stroke, acute heart failure, and CVD death.“There has been considerable improvement in the management of cardiovascular risk factors since the first reports on aspirin use for cardiovascular prevention,” Dr. Del Pinto said in an interview.

“As for hypertension, not only have more effective antihypertensive medications become available, but also evidence has recently emerged in support of a downwards redefinition of blood pressure targets during treatment,” she said. “In this context, in an era when great attention is paid to the personalization of treatment, no specific studies had addressed the association of aspirin use as a primary prevention strategy in a cohort of relatively old, high-risk individuals with treated systolic blood pressure steadily below the recommended target,” she added.

The researchers assessed whether aspirin use in addition to standard blood pressure management (a target of less than 140 mm Hg) decreased risk and improved survival.

The study population included 2,664 adult patients; 29.3% were women, and 24.5% were aged 75 years and older. Half of the patients (1,332) received aspirin and 1,332 did not.

In a multivariate analysis, 42 cardiovascular events occurred in the aspirin group, compared with 20 events in those not exposed to aspirin (hazard ratio, 2.30). The findings were consistent in subgroup analyses of younger individuals, current and former smokers, and patients on statins.

An additional subgroup analysis of individuals randomized to standard care or intensive care in the SPRINT study showed no significant difference in primary outcome rates between individuals who received aspirin and those who did not. The rates for aspirin use vs. non–aspirin use were 5.85% vs. 3.60% in the standard treatment group and 4.66% vs. 2.56% in the intensive treatment group.

The study findings were limited by several factors, including the post hoc design, short follow-up period, and lack of data on the initiation of aspirin and bleeding events, the researchers wrote. However, the results suggest that modern management of hypertension may have redefined the potential benefits of aspirin in patients with hypertension, they concluded.

Findings confirm value of preventive care

“The study was conducted as a post-hoc analysis on an experimental cohort, which must be considered when interpreting the results,” Dr. Del Pinto said.

Despite the limitations, the study findings affirm that effective treatment of major cardiovascular risk factors, such as hypertension, with proven drugs is “a mainstay of the primary prevention of ASCVD,” she emphasized.

As for additional research, “Testing our findings in a dedicated setting with sufficiently long follow-up, where aspirin dose and indication, as well as any possible bleeding event, are reported could expand the clinical meaning of our observations,” said Dr. Del Pinto. “Also, the clinical impact of aspirin, even in combination with novel cardiovascular drugs such as direct oral anticoagulants, in populations exposed to combinations of risk factors, deserves further investigation.”

Data support shared decision-making

“While recent evidence has not shown a benefit of aspirin in the primary prevention of ASCVD in several populations, the subpopulation of patients with hypertension as an ASCVD risk factor is also of interest to the clinician,” Suman Pal, MD, of the University of New Mexico, Albuquerque, said in an interview. “The lack of benefit of aspirin in this study, despite its limitations, was surprising, and I would be eager to see how the role of aspirin in ASCVD prevention would continue to evolve in conjunction with improvement in other therapies for modification of risk factors.”

“The decision to continue aspirin in this subgroup of patients should warrant a discussion with patients and a reexamination of risks and benefits until further data are available,” Dr. Pal emphasized. 

Larger studies with long-term follow-ups would be required to further clarify the role of aspirin in primary prevention of ASCVD in patients with hypertension without diabetes or chronic kidney disease, he added.

Data were supplied courtesy of BioLINCC. The study received no outside funding. The researchers and Dr. Pal had no financial conflicts to disclose.

It may seem like déjà vu, as not much has changed regarding the rankings of top U.S. medical schools over the past 2 years.

The University of Washington, Seattle retained its ranking from the U.S. News & World Report as the top medical school for primary care for 2023. Also repeating its 2022 standing as the top medical school for research is Harvard University. Both schools ranked in the top 10 for primary care and research, with Harvard also ranking in the top spot for half of eight specialties reported.

In the primary care ranking, the top 10 schools after the University of Washington were the University of California, San Francisco; the University of Minnesota; Oregon Health and Science University; the University of North Carolina at Chapel Hill; the University of Colorado; the University of Nebraska Medical Center; the University of California, Davis; and Harvard. Three schools tied for the no. 10 slot: the University of Kansas Medical Center, the University of Massachusetts Chan Medical Center, and the University of Pittsburgh.

The top five schools with the most graduates practicing in primary care specialties are Des Moines University, Iowa (50.6%); the University of Pikeville (Ky.) (46.8%); Western University of Health Sciences, Pomona, California (46%); William Carey University College of Osteopathic Medicine, Hattiesburg, Mississippi (44.7%); and A.T. Still University of Health Sciences, Kirksville, Missouri (44.3%).
 

Best for research

When it comes to schools ranking the highest for research, the Grossman School of Medicine at New York University takes the no. 2 spot after Harvard. Three schools were tied for the no. 3 spot: Columbia University, Johns Hopkins University, and the University of California, San Francisco; and two schools for no. 6: Duke University and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. No. 8 goes to Stanford University, followed by the University of Washington. Rounding out the top 10 is Yale University.

Specialty ranks

The top-ranked schools in eight specialties are as follows:

• Anesthesiology: Harvard
• Family medicine: the University of Washington
• Internal medicine: Johns Hopkins
• Obstetrics/gynecology: Harvard
• Pediatrics: the University of Pennsylvania (Perelman)
• Psychiatry: Harvard
• Radiology: Johns Hopkins
• Surgery: Harvard

Most diverse student body

If you’re looking for a school with significant minority representation, Howard University, Washington, D.C., ranked highest (76.8%), followed by the Wertheim College of Medicine at Florida International University, Miami (43.2%). The University of California, Davis (40%), Sacramento, California, and the University of Vermont (Larner), Burlington (14.1%), tied for third.

Three southern schools take top honors for the most graduates practicing in underserved areas, starting with the University of South Carolina (70.9%), followed by the University of Mississippi (66.2%), and East Tennessee State University (Quillen), Johnson City, Tennessee (65.8%).

The colleges with the most graduates practicing in rural areas are William Carey University College of Osteopathic Medicine (28%), the University of Pikesville (25.6%), and the University of Mississippi (22.1%).
 

College debt

The medical school where graduates have the most debt is Nova Southeastern University Patel College of Osteopathic Medicine, Fort Lauderdale, Florida. Graduates incurred an average debt of $309,206. Western University of Health Sciences graduates racked up $276,840 in debt, followed by graduates of West Virginia School of Osteopathic Medicine, owing $268,416.

Ranking criteria

Each year, U.S. News ranks hundreds of U.S. colleges and universities. Medical schools fall under the rankings for best graduate schools.

U.S. News surveyed 192 medical and osteopathic schools accredited in 2021 by the Liaison Committee on Medical Education or the American Osteopathic Association. Among the schools surveyed in fall 2021 and early 2022, 130 schools responded. Of those, 124 were included in both the research and primary care rankings.

The criteria for ranking include faculty resources, academic achievements of entering students, and qualitative assessments by schools and residency directors.

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

It may seem like déjà vu, as not much has changed regarding the rankings of top U.S. medical schools over the past 2 years.

The University of Washington, Seattle retained its ranking from the U.S. News & World Report as the top medical school for primary care for 2023. Also repeating its 2022 standing as the top medical school for research is Harvard University. Both schools ranked in the top 10 for primary care and research, with Harvard also ranking in the top spot for half of eight specialties reported.

In the primary care ranking, the top 10 schools after the University of Washington were the University of California, San Francisco; the University of Minnesota; Oregon Health and Science University; the University of North Carolina at Chapel Hill; the University of Colorado; the University of Nebraska Medical Center; the University of California, Davis; and Harvard. Three schools tied for the no. 10 slot: the University of Kansas Medical Center, the University of Massachusetts Chan Medical Center, and the University of Pittsburgh.

The top five schools with the most graduates practicing in primary care specialties are Des Moines University, Iowa (50.6%); the University of Pikeville (Ky.) (46.8%); Western University of Health Sciences, Pomona, California (46%); William Carey University College of Osteopathic Medicine, Hattiesburg, Mississippi (44.7%); and A.T. Still University of Health Sciences, Kirksville, Missouri (44.3%).
 

Best for research

When it comes to schools ranking the highest for research, the Grossman School of Medicine at New York University takes the no. 2 spot after Harvard. Three schools were tied for the no. 3 spot: Columbia University, Johns Hopkins University, and the University of California, San Francisco; and two schools for no. 6: Duke University and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. No. 8 goes to Stanford University, followed by the University of Washington. Rounding out the top 10 is Yale University.

Specialty ranks

The top-ranked schools in eight specialties are as follows:

• Anesthesiology: Harvard
• Family medicine: the University of Washington
• Internal medicine: Johns Hopkins
• Obstetrics/gynecology: Harvard
• Pediatrics: the University of Pennsylvania (Perelman)
• Psychiatry: Harvard
• Radiology: Johns Hopkins
• Surgery: Harvard

Most diverse student body

If you’re looking for a school with significant minority representation, Howard University, Washington, D.C., ranked highest (76.8%), followed by the Wertheim College of Medicine at Florida International University, Miami (43.2%). The University of California, Davis (40%), Sacramento, California, and the University of Vermont (Larner), Burlington (14.1%), tied for third.

Three southern schools take top honors for the most graduates practicing in underserved areas, starting with the University of South Carolina (70.9%), followed by the University of Mississippi (66.2%), and East Tennessee State University (Quillen), Johnson City, Tennessee (65.8%).

The colleges with the most graduates practicing in rural areas are William Carey University College of Osteopathic Medicine (28%), the University of Pikesville (25.6%), and the University of Mississippi (22.1%).
 

College debt

The medical school where graduates have the most debt is Nova Southeastern University Patel College of Osteopathic Medicine, Fort Lauderdale, Florida. Graduates incurred an average debt of $309,206. Western University of Health Sciences graduates racked up $276,840 in debt, followed by graduates of West Virginia School of Osteopathic Medicine, owing $268,416.

Ranking criteria

Each year, U.S. News ranks hundreds of U.S. colleges and universities. Medical schools fall under the rankings for best graduate schools.

U.S. News surveyed 192 medical and osteopathic schools accredited in 2021 by the Liaison Committee on Medical Education or the American Osteopathic Association. Among the schools surveyed in fall 2021 and early 2022, 130 schools responded. Of those, 124 were included in both the research and primary care rankings.

The criteria for ranking include faculty resources, academic achievements of entering students, and qualitative assessments by schools and residency directors.

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

It may seem like déjà vu, as not much has changed regarding the rankings of top U.S. medical schools over the past 2 years.

The University of Washington, Seattle retained its ranking from the U.S. News & World Report as the top medical school for primary care for 2023. Also repeating its 2022 standing as the top medical school for research is Harvard University. Both schools ranked in the top 10 for primary care and research, with Harvard also ranking in the top spot for half of eight specialties reported.

In the primary care ranking, the top 10 schools after the University of Washington were the University of California, San Francisco; the University of Minnesota; Oregon Health and Science University; the University of North Carolina at Chapel Hill; the University of Colorado; the University of Nebraska Medical Center; the University of California, Davis; and Harvard. Three schools tied for the no. 10 slot: the University of Kansas Medical Center, the University of Massachusetts Chan Medical Center, and the University of Pittsburgh.

The top five schools with the most graduates practicing in primary care specialties are Des Moines University, Iowa (50.6%); the University of Pikeville (Ky.) (46.8%); Western University of Health Sciences, Pomona, California (46%); William Carey University College of Osteopathic Medicine, Hattiesburg, Mississippi (44.7%); and A.T. Still University of Health Sciences, Kirksville, Missouri (44.3%).
 

Best for research

When it comes to schools ranking the highest for research, the Grossman School of Medicine at New York University takes the no. 2 spot after Harvard. Three schools were tied for the no. 3 spot: Columbia University, Johns Hopkins University, and the University of California, San Francisco; and two schools for no. 6: Duke University and the Perelman School of Medicine at the University of Pennsylvania, Philadelphia. No. 8 goes to Stanford University, followed by the University of Washington. Rounding out the top 10 is Yale University.

Specialty ranks

The top-ranked schools in eight specialties are as follows:

• Anesthesiology: Harvard
• Family medicine: the University of Washington
• Internal medicine: Johns Hopkins
• Obstetrics/gynecology: Harvard
• Pediatrics: the University of Pennsylvania (Perelman)
• Psychiatry: Harvard
• Radiology: Johns Hopkins
• Surgery: Harvard

Most diverse student body

If you’re looking for a school with significant minority representation, Howard University, Washington, D.C., ranked highest (76.8%), followed by the Wertheim College of Medicine at Florida International University, Miami (43.2%). The University of California, Davis (40%), Sacramento, California, and the University of Vermont (Larner), Burlington (14.1%), tied for third.

Three southern schools take top honors for the most graduates practicing in underserved areas, starting with the University of South Carolina (70.9%), followed by the University of Mississippi (66.2%), and East Tennessee State University (Quillen), Johnson City, Tennessee (65.8%).

The colleges with the most graduates practicing in rural areas are William Carey University College of Osteopathic Medicine (28%), the University of Pikesville (25.6%), and the University of Mississippi (22.1%).
 

College debt

The medical school where graduates have the most debt is Nova Southeastern University Patel College of Osteopathic Medicine, Fort Lauderdale, Florida. Graduates incurred an average debt of $309,206. Western University of Health Sciences graduates racked up $276,840 in debt, followed by graduates of West Virginia School of Osteopathic Medicine, owing $268,416.

Ranking criteria

Each year, U.S. News ranks hundreds of U.S. colleges and universities. Medical schools fall under the rankings for best graduate schools.

U.S. News surveyed 192 medical and osteopathic schools accredited in 2021 by the Liaison Committee on Medical Education or the American Osteopathic Association. Among the schools surveyed in fall 2021 and early 2022, 130 schools responded. Of those, 124 were included in both the research and primary care rankings.

The criteria for ranking include faculty resources, academic achievements of entering students, and qualitative assessments by schools and residency directors.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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