Peter Russell

Health charities called for action to address racial health disparities after population-wide analysis by the UK Health Security Agency found that Black and Asian neonates had a significantly higher risk of early-onset group B streptococcal disease (GBS), compared with White infants.

One support group said more research was now needed to identify the cause of the disparity, and called for pregnant women to be better informed about the disease and what it could mean for them and their baby.

The study, published in Pediatrics, used UKHSA data on laboratory-confirmed infant group B streptococcal (iGBS) disease cases between Jan. 1, 2016, and Dec. 31, 2020, and were linked to hospital ethnicity records.

Cases of iGBS were defined as isolation of Streptococcus agalactiae from a normally sterile site at 0-6 days of life for early-onset iGBS and 7-90 days for late-onset disease.
 

Hospital data and parent-reported ethnicity

Researchers found 2,512 iGBS cases in England during the study period, 65.3% were early onset and 34.8% late onset, equivalent to 0.52 and 0.28 cases per 1000 live births respectively.

Researchers were able to link 85.6% of those to ethnicity. Among those 2,149 cases, Black infants had a 48% higher risk, and Asian infants a 40% higher risk of early onset iGBS, compared with White infants. Among those from an Asian background, the risk was 87% higher for Bangladeshi and 38% higher for Pakistani neonates.

Rates of early onset iGBS per 1,000 live births were 0.43 for White infants, 0.63 for Black infants, and 0.60 for those of Asian ethnicity.

In contrast, Indian infants had an early-onset rate of 0.47 per 1,000 live births, which was similar to White infants.

Black infants had 57% higher rates of late-onset iGBS (0.37) than White infants (0.24), the researchers reported.

The study authors highlighted previous research which found higher prevalence of group B streptococcal colonization in mothers from Black and some Asian ethnic groups, but lower prevalence in mothers from the Indian subcontinent. More research was needed to establish causes, the researchers said, including whether higher preterm birth rates in minority ethnic groups led to increased iGBS risk in neonates, or whether maternal group B streptococcal disease led to higher preterm birth rates and subsequent neonatal iGBS.

The researchers concluded: “Understanding the factors underpinning differences in rates of early-onset iGBS within south Asian groups in England may lead to new opportunities for prevention such as prioritized antenatal screening. Strategies to prevent neonatal iGBS must be tailored from high-quality quantitative and qualitative data to reach all women and protect all infants, irrespective of racial or ethnic background.”
 

‘Shocking but not surprising’

Commenting on the study, Edward Morris, president of the Royal College of Obstetricians and Gynaecologists, said: “This research is striking reading, and is yet another example of how far we have to go to tackle health inequalities within women’s health care.”

Philip Steer, professor emeritus at Imperial College London, said that the results were “consistent with previous reports of higher GBS carriage and higher maternal and neonatal mortality rates in minority groups” and “emphasize the importance of studying not just whether, but why, these differences exist.” He added: “We need to understand the reasons for the differences before we can design much-needed intervention to eliminate them.”

Jane Plumb, chief executive of Group B Strep Support, called the findings “shocking, but unfortunately not surprising” and said that they offered “another example of racial disparities in maternal and neonatal health.” She said: “We’re calling for all pregnant women and birthing people to be informed about GBS and its risks, so they can make empowered choices for themselves and their baby. It is also critical that trusts sign up to take part in the internationally significant [National Institute for Health and Care Research]–funded GBS3 clinical trial, designed to improve the prevention of GBS infection.”

Baroness Shaista Gohir, chief executive of the Muslim Women’s Network, said: “With significantly higher rates of group B Strep infection in Black and Asian babies, greater efforts must be made to improve awareness among pregnant women within these communities.”

A version of this article first appeared on Medscape UK.

Health charities called for action to address racial health disparities after population-wide analysis by the UK Health Security Agency found that Black and Asian neonates had a significantly higher risk of early-onset group B streptococcal disease (GBS), compared with White infants.

One support group said more research was now needed to identify the cause of the disparity, and called for pregnant women to be better informed about the disease and what it could mean for them and their baby.

The study, published in Pediatrics, used UKHSA data on laboratory-confirmed infant group B streptococcal (iGBS) disease cases between Jan. 1, 2016, and Dec. 31, 2020, and were linked to hospital ethnicity records.

Cases of iGBS were defined as isolation of Streptococcus agalactiae from a normally sterile site at 0-6 days of life for early-onset iGBS and 7-90 days for late-onset disease.
 

Hospital data and parent-reported ethnicity

Researchers found 2,512 iGBS cases in England during the study period, 65.3% were early onset and 34.8% late onset, equivalent to 0.52 and 0.28 cases per 1000 live births respectively.

Researchers were able to link 85.6% of those to ethnicity. Among those 2,149 cases, Black infants had a 48% higher risk, and Asian infants a 40% higher risk of early onset iGBS, compared with White infants. Among those from an Asian background, the risk was 87% higher for Bangladeshi and 38% higher for Pakistani neonates.

Rates of early onset iGBS per 1,000 live births were 0.43 for White infants, 0.63 for Black infants, and 0.60 for those of Asian ethnicity.

In contrast, Indian infants had an early-onset rate of 0.47 per 1,000 live births, which was similar to White infants.

Black infants had 57% higher rates of late-onset iGBS (0.37) than White infants (0.24), the researchers reported.

The study authors highlighted previous research which found higher prevalence of group B streptococcal colonization in mothers from Black and some Asian ethnic groups, but lower prevalence in mothers from the Indian subcontinent. More research was needed to establish causes, the researchers said, including whether higher preterm birth rates in minority ethnic groups led to increased iGBS risk in neonates, or whether maternal group B streptococcal disease led to higher preterm birth rates and subsequent neonatal iGBS.

The researchers concluded: “Understanding the factors underpinning differences in rates of early-onset iGBS within south Asian groups in England may lead to new opportunities for prevention such as prioritized antenatal screening. Strategies to prevent neonatal iGBS must be tailored from high-quality quantitative and qualitative data to reach all women and protect all infants, irrespective of racial or ethnic background.”
 

‘Shocking but not surprising’

Commenting on the study, Edward Morris, president of the Royal College of Obstetricians and Gynaecologists, said: “This research is striking reading, and is yet another example of how far we have to go to tackle health inequalities within women’s health care.”

Philip Steer, professor emeritus at Imperial College London, said that the results were “consistent with previous reports of higher GBS carriage and higher maternal and neonatal mortality rates in minority groups” and “emphasize the importance of studying not just whether, but why, these differences exist.” He added: “We need to understand the reasons for the differences before we can design much-needed intervention to eliminate them.”

Jane Plumb, chief executive of Group B Strep Support, called the findings “shocking, but unfortunately not surprising” and said that they offered “another example of racial disparities in maternal and neonatal health.” She said: “We’re calling for all pregnant women and birthing people to be informed about GBS and its risks, so they can make empowered choices for themselves and their baby. It is also critical that trusts sign up to take part in the internationally significant [National Institute for Health and Care Research]–funded GBS3 clinical trial, designed to improve the prevention of GBS infection.”

Baroness Shaista Gohir, chief executive of the Muslim Women’s Network, said: “With significantly higher rates of group B Strep infection in Black and Asian babies, greater efforts must be made to improve awareness among pregnant women within these communities.”

A version of this article first appeared on Medscape UK.

Health charities called for action to address racial health disparities after population-wide analysis by the UK Health Security Agency found that Black and Asian neonates had a significantly higher risk of early-onset group B streptococcal disease (GBS), compared with White infants.

One support group said more research was now needed to identify the cause of the disparity, and called for pregnant women to be better informed about the disease and what it could mean for them and their baby.

The study, published in Pediatrics, used UKHSA data on laboratory-confirmed infant group B streptococcal (iGBS) disease cases between Jan. 1, 2016, and Dec. 31, 2020, and were linked to hospital ethnicity records.

Cases of iGBS were defined as isolation of Streptococcus agalactiae from a normally sterile site at 0-6 days of life for early-onset iGBS and 7-90 days for late-onset disease.
 

Hospital data and parent-reported ethnicity

Researchers found 2,512 iGBS cases in England during the study period, 65.3% were early onset and 34.8% late onset, equivalent to 0.52 and 0.28 cases per 1000 live births respectively.

Researchers were able to link 85.6% of those to ethnicity. Among those 2,149 cases, Black infants had a 48% higher risk, and Asian infants a 40% higher risk of early onset iGBS, compared with White infants. Among those from an Asian background, the risk was 87% higher for Bangladeshi and 38% higher for Pakistani neonates.

Rates of early onset iGBS per 1,000 live births were 0.43 for White infants, 0.63 for Black infants, and 0.60 for those of Asian ethnicity.

In contrast, Indian infants had an early-onset rate of 0.47 per 1,000 live births, which was similar to White infants.

Black infants had 57% higher rates of late-onset iGBS (0.37) than White infants (0.24), the researchers reported.

The study authors highlighted previous research which found higher prevalence of group B streptococcal colonization in mothers from Black and some Asian ethnic groups, but lower prevalence in mothers from the Indian subcontinent. More research was needed to establish causes, the researchers said, including whether higher preterm birth rates in minority ethnic groups led to increased iGBS risk in neonates, or whether maternal group B streptococcal disease led to higher preterm birth rates and subsequent neonatal iGBS.

The researchers concluded: “Understanding the factors underpinning differences in rates of early-onset iGBS within south Asian groups in England may lead to new opportunities for prevention such as prioritized antenatal screening. Strategies to prevent neonatal iGBS must be tailored from high-quality quantitative and qualitative data to reach all women and protect all infants, irrespective of racial or ethnic background.”
 

‘Shocking but not surprising’

Commenting on the study, Edward Morris, president of the Royal College of Obstetricians and Gynaecologists, said: “This research is striking reading, and is yet another example of how far we have to go to tackle health inequalities within women’s health care.”

Philip Steer, professor emeritus at Imperial College London, said that the results were “consistent with previous reports of higher GBS carriage and higher maternal and neonatal mortality rates in minority groups” and “emphasize the importance of studying not just whether, but why, these differences exist.” He added: “We need to understand the reasons for the differences before we can design much-needed intervention to eliminate them.”

Jane Plumb, chief executive of Group B Strep Support, called the findings “shocking, but unfortunately not surprising” and said that they offered “another example of racial disparities in maternal and neonatal health.” She said: “We’re calling for all pregnant women and birthing people to be informed about GBS and its risks, so they can make empowered choices for themselves and their baby. It is also critical that trusts sign up to take part in the internationally significant [National Institute for Health and Care Research]–funded GBS3 clinical trial, designed to improve the prevention of GBS infection.”

Baroness Shaista Gohir, chief executive of the Muslim Women’s Network, said: “With significantly higher rates of group B Strep infection in Black and Asian babies, greater efforts must be made to improve awareness among pregnant women within these communities.”

A version of this article first appeared on Medscape UK.

Cases of early-stage prostate cancer could be missed because official guidelines and health messaging place a misleading emphasis on urinary symptoms, according to experts.

Researchers from the University of Cambridge said there was “no evidence of a causal link between prostate cancer and either prostate size or troublesome male urinary symptoms” and called for early prostate cancer to be rebranded “as primarily an asymptomatic disease” to encourage more men to get tested earlier when the condition is more treatable.

The authors of the ‘Opinion’ article, published in the journal BMC Medicine, argued that persistence by health bodies in flagging prostate cancer as a symptomatic disease – frequently presenting with slow urinary flow, frequency, and nocturia – worked against efforts to reduce mortality rates, which had remained largely unaltered in the UK and many other countries over the past decade and largely driven by late detection.

Public advice by the NHS, for instance, acknowledges that prostate cancer may be symptomless for many years but lists ‘an increased need to pee,’ ‘straining while you pee,’ and ‘a feeling that your bladder has not fully emptied’ as the top three signs that should not be ignored.
 

Messaging gives men ‘a false sense of security’

No wonder, the authors argued, that lower urinary tract symptoms and prostate cancer risk had become “causally associated,” as reflected in a 2003 survey finding that 86% of the public thought that prostate cancer was accompanied by symptoms, while only 1% were aware that it could be asymptomatic.

Lead study author Vincent Gnanapragasam, PhD, professor of urology at the University of Cambridge and an honorary consultant urologist at Addenbrooke’s Hospital, maintained: “We urgently need to recognize that the information currently given to the public risks giving men a false sense of security if they don’t have any urinary symptoms. We need to emphasize that prostate cancer can be a silent or asymptomatic disease, particularly in its curable stages. Waiting out for urinary symptoms may mean missing opportunities to catch the disease when it’s treatable.”

Although prostate enlargement can cause the lower urinary tract problems mentioned in public health messaging, the researchers said this is rarely due to malignant prostate tumors, quoting some research suggesting that “mean prostate volume was lower in men found to have prostate cancer compared to those with benign biopsies.” The Prostate testing for cancer and Treatment (ProtecT) trial in the UK concluded there was “no association or a negative association with more severe symptoms and prostate cancer,” they said.
 

Screening program

The researchers said they were not advocating introducing an immediate screening program, and they acknowledged that updating advice to focus on the often symptomless nature of the disease could lead to an influx of men requesting a PSA test from their GPs. But concerns this could result in overinvestigation and overtreatment “which previously deterred greater promotion of PSA testing in men with no symptoms” had been lessened by today’s “image-based diagnostics and risk-adapted management strategies,” they said.

The authors hoped for an eventual “intelligent tiered screening program” for prostate cancer to be introduced. In the meantime, Dr. Gnanapragasam said, “We’re calling on organizations such as the NHS, as well as patient charities and the media, to review the current public messaging.”

Amy Rylance, head of improving care at Prostate Cancer UK said: “This study reinforces the fact that men shouldn’t wait for symptoms before they act. Early prostate cancer is often symptomless, which is why we urge men to be aware of their risk instead. This is particularly important for men over 50, Black men, and men with a family history of prostate cancer.

“We know that most people assume that they would have symptoms if they had prostate cancer, and that not having straightforward signs to look out for can cause anxiety or confusion. That’s why our risk checker is designed to help men understand their risk factors and what action they can take, regardless of symptoms.”

A version of this article first appeared on Medscape.co.uk.

Cases of early-stage prostate cancer could be missed because official guidelines and health messaging place a misleading emphasis on urinary symptoms, according to experts.

Researchers from the University of Cambridge said there was “no evidence of a causal link between prostate cancer and either prostate size or troublesome male urinary symptoms” and called for early prostate cancer to be rebranded “as primarily an asymptomatic disease” to encourage more men to get tested earlier when the condition is more treatable.

The authors of the ‘Opinion’ article, published in the journal BMC Medicine, argued that persistence by health bodies in flagging prostate cancer as a symptomatic disease – frequently presenting with slow urinary flow, frequency, and nocturia – worked against efforts to reduce mortality rates, which had remained largely unaltered in the UK and many other countries over the past decade and largely driven by late detection.

Public advice by the NHS, for instance, acknowledges that prostate cancer may be symptomless for many years but lists ‘an increased need to pee,’ ‘straining while you pee,’ and ‘a feeling that your bladder has not fully emptied’ as the top three signs that should not be ignored.
 

Messaging gives men ‘a false sense of security’

No wonder, the authors argued, that lower urinary tract symptoms and prostate cancer risk had become “causally associated,” as reflected in a 2003 survey finding that 86% of the public thought that prostate cancer was accompanied by symptoms, while only 1% were aware that it could be asymptomatic.

Lead study author Vincent Gnanapragasam, PhD, professor of urology at the University of Cambridge and an honorary consultant urologist at Addenbrooke’s Hospital, maintained: “We urgently need to recognize that the information currently given to the public risks giving men a false sense of security if they don’t have any urinary symptoms. We need to emphasize that prostate cancer can be a silent or asymptomatic disease, particularly in its curable stages. Waiting out for urinary symptoms may mean missing opportunities to catch the disease when it’s treatable.”

Although prostate enlargement can cause the lower urinary tract problems mentioned in public health messaging, the researchers said this is rarely due to malignant prostate tumors, quoting some research suggesting that “mean prostate volume was lower in men found to have prostate cancer compared to those with benign biopsies.” The Prostate testing for cancer and Treatment (ProtecT) trial in the UK concluded there was “no association or a negative association with more severe symptoms and prostate cancer,” they said.
 

Screening program

The researchers said they were not advocating introducing an immediate screening program, and they acknowledged that updating advice to focus on the often symptomless nature of the disease could lead to an influx of men requesting a PSA test from their GPs. But concerns this could result in overinvestigation and overtreatment “which previously deterred greater promotion of PSA testing in men with no symptoms” had been lessened by today’s “image-based diagnostics and risk-adapted management strategies,” they said.

The authors hoped for an eventual “intelligent tiered screening program” for prostate cancer to be introduced. In the meantime, Dr. Gnanapragasam said, “We’re calling on organizations such as the NHS, as well as patient charities and the media, to review the current public messaging.”

Amy Rylance, head of improving care at Prostate Cancer UK said: “This study reinforces the fact that men shouldn’t wait for symptoms before they act. Early prostate cancer is often symptomless, which is why we urge men to be aware of their risk instead. This is particularly important for men over 50, Black men, and men with a family history of prostate cancer.

“We know that most people assume that they would have symptoms if they had prostate cancer, and that not having straightforward signs to look out for can cause anxiety or confusion. That’s why our risk checker is designed to help men understand their risk factors and what action they can take, regardless of symptoms.”

A version of this article first appeared on Medscape.co.uk.

Cases of early-stage prostate cancer could be missed because official guidelines and health messaging place a misleading emphasis on urinary symptoms, according to experts.

Researchers from the University of Cambridge said there was “no evidence of a causal link between prostate cancer and either prostate size or troublesome male urinary symptoms” and called for early prostate cancer to be rebranded “as primarily an asymptomatic disease” to encourage more men to get tested earlier when the condition is more treatable.

The authors of the ‘Opinion’ article, published in the journal BMC Medicine, argued that persistence by health bodies in flagging prostate cancer as a symptomatic disease – frequently presenting with slow urinary flow, frequency, and nocturia – worked against efforts to reduce mortality rates, which had remained largely unaltered in the UK and many other countries over the past decade and largely driven by late detection.

Public advice by the NHS, for instance, acknowledges that prostate cancer may be symptomless for many years but lists ‘an increased need to pee,’ ‘straining while you pee,’ and ‘a feeling that your bladder has not fully emptied’ as the top three signs that should not be ignored.
 

Messaging gives men ‘a false sense of security’

No wonder, the authors argued, that lower urinary tract symptoms and prostate cancer risk had become “causally associated,” as reflected in a 2003 survey finding that 86% of the public thought that prostate cancer was accompanied by symptoms, while only 1% were aware that it could be asymptomatic.

Lead study author Vincent Gnanapragasam, PhD, professor of urology at the University of Cambridge and an honorary consultant urologist at Addenbrooke’s Hospital, maintained: “We urgently need to recognize that the information currently given to the public risks giving men a false sense of security if they don’t have any urinary symptoms. We need to emphasize that prostate cancer can be a silent or asymptomatic disease, particularly in its curable stages. Waiting out for urinary symptoms may mean missing opportunities to catch the disease when it’s treatable.”

Although prostate enlargement can cause the lower urinary tract problems mentioned in public health messaging, the researchers said this is rarely due to malignant prostate tumors, quoting some research suggesting that “mean prostate volume was lower in men found to have prostate cancer compared to those with benign biopsies.” The Prostate testing for cancer and Treatment (ProtecT) trial in the UK concluded there was “no association or a negative association with more severe symptoms and prostate cancer,” they said.
 

Screening program

The researchers said they were not advocating introducing an immediate screening program, and they acknowledged that updating advice to focus on the often symptomless nature of the disease could lead to an influx of men requesting a PSA test from their GPs. But concerns this could result in overinvestigation and overtreatment “which previously deterred greater promotion of PSA testing in men with no symptoms” had been lessened by today’s “image-based diagnostics and risk-adapted management strategies,” they said.

The authors hoped for an eventual “intelligent tiered screening program” for prostate cancer to be introduced. In the meantime, Dr. Gnanapragasam said, “We’re calling on organizations such as the NHS, as well as patient charities and the media, to review the current public messaging.”

Amy Rylance, head of improving care at Prostate Cancer UK said: “This study reinforces the fact that men shouldn’t wait for symptoms before they act. Early prostate cancer is often symptomless, which is why we urge men to be aware of their risk instead. This is particularly important for men over 50, Black men, and men with a family history of prostate cancer.

“We know that most people assume that they would have symptoms if they had prostate cancer, and that not having straightforward signs to look out for can cause anxiety or confusion. That’s why our risk checker is designed to help men understand their risk factors and what action they can take, regardless of symptoms.”

A version of this article first appeared on Medscape.co.uk.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

U.K. scientists said microplastics may pose even more of a threat than previously thought after confirming their presence in lung tissue taken from living people.

Microplastics were identified in all lung regions, but significantly higher levels were found in the lower lung.

The results supported inhalation as an exposure risk, according to the team from the University of Hull and Hull York Medical School (England), who said their findings could support further investigations into the effects of airborne microplastics on respiratory health.

The study, published in Science of the Total Environment, used lung tissue collected from surgical procedures on patients during routine medical care at Castle Hill Hospital in East Yorkshire.
 

Polypropylene and polyethylene

It found 39 microplastics in 11 of the 13 lung tissue samples tested using micro-Fourier-transform infrared (μFTIR) analysis, which the scientists said was considerably higher than results from previous laboratory tests.

Of microplastics detected, 12 polymer types were identified, of which the most common were polypropylene, (23%) polyethylene terephthalate (18%), and resin (15%). The fibers are commonly found in packaging, bottles, clothing, rope and twine manufacture, and other industries, the scientists said.

Microplastics with dimensions as small as 4 μm were found, but the scientists said they were surprised to discover samples as large as greater than 2 mm within all lung region samples, with the majority being fibrous and fragmented.

The study identified 11 microplastics in the upper part of the lung, seven in the mid part, and 21 in the lower part of the lung.

Laura Sadofsky, the study’s lead author, said: “Microplastics have previously been found in human cadaver autopsy samples. This is the first robust study to show microplastics in lungs from live people. It also shows that they are in the lower parts of the lung. Lung airways are very narrow, so no one thought they could possibly get there, but they clearly have.”

There were also considerably higher levels of microplastics found in male patients, compared with female patients.
 

Future investigations into health implications

“The characterization of types and levels of microplastics we have found can now inform realistic conditions for laboratory exposure experiments with the aim of determining health impacts,” said Laura Sadofsky, who is a senior lecturer in respiratory medicine in the Centre for Atherothrombotic and Metabolic Research at Hull York Medical School.

The latest investigation followed previous research by the medical school and the University of Hull, which found high levels of atmospheric microplastics within the Humber region.

That study, published in Atmosphere, identified resins, which could have originated from degraded roads, paint marking, or tire rubber, as well as polyethylene fibers.

A version of this article first appeared on Medscape UK.

U.K. scientists said microplastics may pose even more of a threat than previously thought after confirming their presence in lung tissue taken from living people.

Microplastics were identified in all lung regions, but significantly higher levels were found in the lower lung.

The results supported inhalation as an exposure risk, according to the team from the University of Hull and Hull York Medical School (England), who said their findings could support further investigations into the effects of airborne microplastics on respiratory health.

The study, published in Science of the Total Environment, used lung tissue collected from surgical procedures on patients during routine medical care at Castle Hill Hospital in East Yorkshire.
 

Polypropylene and polyethylene

It found 39 microplastics in 11 of the 13 lung tissue samples tested using micro-Fourier-transform infrared (μFTIR) analysis, which the scientists said was considerably higher than results from previous laboratory tests.

Of microplastics detected, 12 polymer types were identified, of which the most common were polypropylene, (23%) polyethylene terephthalate (18%), and resin (15%). The fibers are commonly found in packaging, bottles, clothing, rope and twine manufacture, and other industries, the scientists said.

Microplastics with dimensions as small as 4 μm were found, but the scientists said they were surprised to discover samples as large as greater than 2 mm within all lung region samples, with the majority being fibrous and fragmented.

The study identified 11 microplastics in the upper part of the lung, seven in the mid part, and 21 in the lower part of the lung.

Laura Sadofsky, the study’s lead author, said: “Microplastics have previously been found in human cadaver autopsy samples. This is the first robust study to show microplastics in lungs from live people. It also shows that they are in the lower parts of the lung. Lung airways are very narrow, so no one thought they could possibly get there, but they clearly have.”

There were also considerably higher levels of microplastics found in male patients, compared with female patients.
 

Future investigations into health implications

“The characterization of types and levels of microplastics we have found can now inform realistic conditions for laboratory exposure experiments with the aim of determining health impacts,” said Laura Sadofsky, who is a senior lecturer in respiratory medicine in the Centre for Atherothrombotic and Metabolic Research at Hull York Medical School.

The latest investigation followed previous research by the medical school and the University of Hull, which found high levels of atmospheric microplastics within the Humber region.

That study, published in Atmosphere, identified resins, which could have originated from degraded roads, paint marking, or tire rubber, as well as polyethylene fibers.

A version of this article first appeared on Medscape UK.

U.K. scientists said microplastics may pose even more of a threat than previously thought after confirming their presence in lung tissue taken from living people.

Microplastics were identified in all lung regions, but significantly higher levels were found in the lower lung.

The results supported inhalation as an exposure risk, according to the team from the University of Hull and Hull York Medical School (England), who said their findings could support further investigations into the effects of airborne microplastics on respiratory health.

The study, published in Science of the Total Environment, used lung tissue collected from surgical procedures on patients during routine medical care at Castle Hill Hospital in East Yorkshire.
 

Polypropylene and polyethylene

It found 39 microplastics in 11 of the 13 lung tissue samples tested using micro-Fourier-transform infrared (μFTIR) analysis, which the scientists said was considerably higher than results from previous laboratory tests.

Of microplastics detected, 12 polymer types were identified, of which the most common were polypropylene, (23%) polyethylene terephthalate (18%), and resin (15%). The fibers are commonly found in packaging, bottles, clothing, rope and twine manufacture, and other industries, the scientists said.

Microplastics with dimensions as small as 4 μm were found, but the scientists said they were surprised to discover samples as large as greater than 2 mm within all lung region samples, with the majority being fibrous and fragmented.

The study identified 11 microplastics in the upper part of the lung, seven in the mid part, and 21 in the lower part of the lung.

Laura Sadofsky, the study’s lead author, said: “Microplastics have previously been found in human cadaver autopsy samples. This is the first robust study to show microplastics in lungs from live people. It also shows that they are in the lower parts of the lung. Lung airways are very narrow, so no one thought they could possibly get there, but they clearly have.”

There were also considerably higher levels of microplastics found in male patients, compared with female patients.
 

Future investigations into health implications

“The characterization of types and levels of microplastics we have found can now inform realistic conditions for laboratory exposure experiments with the aim of determining health impacts,” said Laura Sadofsky, who is a senior lecturer in respiratory medicine in the Centre for Atherothrombotic and Metabolic Research at Hull York Medical School.

The latest investigation followed previous research by the medical school and the University of Hull, which found high levels of atmospheric microplastics within the Humber region.

That study, published in Atmosphere, identified resins, which could have originated from degraded roads, paint marking, or tire rubber, as well as polyethylene fibers.

A version of this article first appeared on Medscape UK.

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

Cancer specialists have expressed disappointment at a decision by the National Institute for Health and Care Excellence not to recommend a targeted drug that can delay progression of a type of prostate cancer.

In draft guidance, NICE rejected olaparib (Lynparza, AstraZeneca) as a treatment option for hormone-relapsed metastatic prostate cancer with BRCA1/2 mutations.

The list price of the poly (ADP-ribose) polymerase inhibitor, at 37,491 pounds for an average cost of treatment, meant it was not cost effective to recommend for routine NHS use, the medicines regulator said.

The Institute of Cancer Research said the decision by NICE put patients in England and Wales at a disadvantage to those in Scotland where the regulator had approved olaparib for men with the same condition under a patient access scheme.

Kristian Helin, ICR chief executive, said: “I urge NICE and the manufacturer to come back to the table and try to find agreement on a way to make olaparib available at an agreeable price.”
 

Encouraging clinical evidence

Results from the PROfound trial, published in 2020 in the New England Journal of Medicine, suggested that progression-free survival for patients with prostate cancers who had faulty BRCA2, BRCA1, or ATM genes was significantly longer in the olaparib group than in a control group who received either enzalutamide or abiraterone.

Median survival in the Olaparib cohort was 7.4 months, compared with 3.6 months in the control group.

Retreatment with abiraterone or enzalutamide is not considered effective for men with this type of prostate cancer, and is not standard care in the NHS, NICE said.

Current treatment for metastatic hormone-relapsed prostate cancer is chemotherapy with docetaxel, cabazitaxel, or radium-223 dichloride.

NICE acknowledged that while an indirect comparison suggested that in men previously treated with docetaxel, olaparib increased survival, compared with cabazitaxel, there were no evidence directly comparing them.
 

Consultation period

Gillian Leng, CBE, NICE chief executive, said: “We know how important it is for people with this type of prostate cancer to have more treatment options that can help them live longer and enable them to maintain or improve their quality of life, as well as delay chemotherapy and its associated side effects.

“We’re therefore disappointed not to be able to recommend olaparib for use in this way. However, the company’s own economic model demonstrated that the drug does not offer enough benefit to justify the price it is asking.

“We’ll continue working with the company to try and address the issues highlighted by the committee.”

Johann De Bono, professor of experimental cancer medicine at the ICR, who leads the PROfound trial, said: “Olaparib is a precision drug that can extend life for men with some mutations in their tumors while sparing them the side effects of chemotherapy.

“I was delighted when olaparib was approved for NHS patients in Scotland earlier this year – and it’s disappointing that this decision means their counterparts in England and Wales will miss out on such a valuable new treatment option. It’s an example of the barriers that exist to making innovative drugs available at prices that the NHS can afford and is going to result in postcode prescribing across the U.K.”

The list price of olaparib is 2,317.50 pounds for a pack of 56 tablets covering 14 days of treatment. A confidential discount has been agreed by the manufacturer to make olaparib available to the NHS.

It is estimated that around 100 men would be eligible for treatment with olaparib if it was to be approved by NICE.

Consultation on the draft guidance closes on Jan. 31.

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

Cancer specialists have expressed disappointment at a decision by the National Institute for Health and Care Excellence not to recommend a targeted drug that can delay progression of a type of prostate cancer.

In draft guidance, NICE rejected olaparib (Lynparza, AstraZeneca) as a treatment option for hormone-relapsed metastatic prostate cancer with BRCA1/2 mutations.

The list price of the poly (ADP-ribose) polymerase inhibitor, at 37,491 pounds for an average cost of treatment, meant it was not cost effective to recommend for routine NHS use, the medicines regulator said.

The Institute of Cancer Research said the decision by NICE put patients in England and Wales at a disadvantage to those in Scotland where the regulator had approved olaparib for men with the same condition under a patient access scheme.

Kristian Helin, ICR chief executive, said: “I urge NICE and the manufacturer to come back to the table and try to find agreement on a way to make olaparib available at an agreeable price.”
 

Encouraging clinical evidence

Results from the PROfound trial, published in 2020 in the New England Journal of Medicine, suggested that progression-free survival for patients with prostate cancers who had faulty BRCA2, BRCA1, or ATM genes was significantly longer in the olaparib group than in a control group who received either enzalutamide or abiraterone.

Median survival in the Olaparib cohort was 7.4 months, compared with 3.6 months in the control group.

Retreatment with abiraterone or enzalutamide is not considered effective for men with this type of prostate cancer, and is not standard care in the NHS, NICE said.

Current treatment for metastatic hormone-relapsed prostate cancer is chemotherapy with docetaxel, cabazitaxel, or radium-223 dichloride.

NICE acknowledged that while an indirect comparison suggested that in men previously treated with docetaxel, olaparib increased survival, compared with cabazitaxel, there were no evidence directly comparing them.
 

Consultation period

Gillian Leng, CBE, NICE chief executive, said: “We know how important it is for people with this type of prostate cancer to have more treatment options that can help them live longer and enable them to maintain or improve their quality of life, as well as delay chemotherapy and its associated side effects.

“We’re therefore disappointed not to be able to recommend olaparib for use in this way. However, the company’s own economic model demonstrated that the drug does not offer enough benefit to justify the price it is asking.

“We’ll continue working with the company to try and address the issues highlighted by the committee.”

Johann De Bono, professor of experimental cancer medicine at the ICR, who leads the PROfound trial, said: “Olaparib is a precision drug that can extend life for men with some mutations in their tumors while sparing them the side effects of chemotherapy.

“I was delighted when olaparib was approved for NHS patients in Scotland earlier this year – and it’s disappointing that this decision means their counterparts in England and Wales will miss out on such a valuable new treatment option. It’s an example of the barriers that exist to making innovative drugs available at prices that the NHS can afford and is going to result in postcode prescribing across the U.K.”

The list price of olaparib is 2,317.50 pounds for a pack of 56 tablets covering 14 days of treatment. A confidential discount has been agreed by the manufacturer to make olaparib available to the NHS.

It is estimated that around 100 men would be eligible for treatment with olaparib if it was to be approved by NICE.

Consultation on the draft guidance closes on Jan. 31.

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

Cancer specialists have expressed disappointment at a decision by the National Institute for Health and Care Excellence not to recommend a targeted drug that can delay progression of a type of prostate cancer.

In draft guidance, NICE rejected olaparib (Lynparza, AstraZeneca) as a treatment option for hormone-relapsed metastatic prostate cancer with BRCA1/2 mutations.

The list price of the poly (ADP-ribose) polymerase inhibitor, at 37,491 pounds for an average cost of treatment, meant it was not cost effective to recommend for routine NHS use, the medicines regulator said.

The Institute of Cancer Research said the decision by NICE put patients in England and Wales at a disadvantage to those in Scotland where the regulator had approved olaparib for men with the same condition under a patient access scheme.

Kristian Helin, ICR chief executive, said: “I urge NICE and the manufacturer to come back to the table and try to find agreement on a way to make olaparib available at an agreeable price.”
 

Encouraging clinical evidence

Results from the PROfound trial, published in 2020 in the New England Journal of Medicine, suggested that progression-free survival for patients with prostate cancers who had faulty BRCA2, BRCA1, or ATM genes was significantly longer in the olaparib group than in a control group who received either enzalutamide or abiraterone.

Median survival in the Olaparib cohort was 7.4 months, compared with 3.6 months in the control group.

Retreatment with abiraterone or enzalutamide is not considered effective for men with this type of prostate cancer, and is not standard care in the NHS, NICE said.

Current treatment for metastatic hormone-relapsed prostate cancer is chemotherapy with docetaxel, cabazitaxel, or radium-223 dichloride.

NICE acknowledged that while an indirect comparison suggested that in men previously treated with docetaxel, olaparib increased survival, compared with cabazitaxel, there were no evidence directly comparing them.
 

Consultation period

Gillian Leng, CBE, NICE chief executive, said: “We know how important it is for people with this type of prostate cancer to have more treatment options that can help them live longer and enable them to maintain or improve their quality of life, as well as delay chemotherapy and its associated side effects.

“We’re therefore disappointed not to be able to recommend olaparib for use in this way. However, the company’s own economic model demonstrated that the drug does not offer enough benefit to justify the price it is asking.

“We’ll continue working with the company to try and address the issues highlighted by the committee.”

Johann De Bono, professor of experimental cancer medicine at the ICR, who leads the PROfound trial, said: “Olaparib is a precision drug that can extend life for men with some mutations in their tumors while sparing them the side effects of chemotherapy.

“I was delighted when olaparib was approved for NHS patients in Scotland earlier this year – and it’s disappointing that this decision means their counterparts in England and Wales will miss out on such a valuable new treatment option. It’s an example of the barriers that exist to making innovative drugs available at prices that the NHS can afford and is going to result in postcode prescribing across the U.K.”

The list price of olaparib is 2,317.50 pounds for a pack of 56 tablets covering 14 days of treatment. A confidential discount has been agreed by the manufacturer to make olaparib available to the NHS.

It is estimated that around 100 men would be eligible for treatment with olaparib if it was to be approved by NICE.

Consultation on the draft guidance closes on Jan. 31.

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

Infection with the SARS-CoV-2 virus may provide some immunity for at least 5 months, interim results from a study has found.

The first report from the Sarscov2 Immunity & Reinfection Evaluation (SIREN) study suggested that antibodies from people who had recovered from COVID-19 gave at least 83% protection against reinfection compared with people who had not had the disease before.

However, Public Health England (PHE) researchers said some people with antibodies may still be able to carry and transmit the SARS-CoV-2 virus.

‘Strongly encouraged’

Susan Hopkins, PhD, senior medical advisor at PHE, who is leading the study, said the overall findings were good news. She told a briefing hosted by the Science Media Centre: “I am strongly encouraged that people have immunity that is lasting much more than the few months that was speculated before the summer.”

She added: “It allows people to feel that their prior infection will protect them from future infections but at the same time it is not complete protection, and therefore they still need to be careful when they are out and about.”

PHE scientists said they would continue to assess whether protection might last longer than 5 months.

Eleanor Riley, PhD, professor of immunology and infectious disease at the University of Edinburgh, said the report suggested that “natural infection provides short-term protection against COVID-19 that is very similar to that conferred by vaccination.”

Simon Clarke, PhD, associate professor in cellular microbiology at the University of Reading, said: “The concerning finding is that some people who have COVID antibodies appear to still be able to carry the coronavirus and could spread it to others. This means that the vast majority of the population will either need to have natural immunity or have been immunised for us to fully lift restrictions on our lives.”

The analysis took place before the new variant of SARS-CoV-2 became widespread in the UK. The PHE scientists said that further work was underway to establish whether and to what extent antibodies also provide protection from the VOC202012/01 variant.

Healthcare Workers

The SIREN preprint analysed data from 20,787 health care workers from 102 NHS trusts who had undergone antibody and PCR testing from June 18 to November 9, 2020.

Of those, 6614 tested positive for COVID-19 antibodies.

Of the 44 potential reinfections identified, two were designated ‘probable’ and 42 ‘possible’, based on available evidence.

Both of the two individuals classified as probable reinfections reported having experienced COVID-19 symptoms during the first wave of the pandemic but were not tested at the time. Both reported that their symptoms were less severe the second time.

None of the 44 potential reinfection cases were PCR tested during the first wave, but all tested positive for COVID-19 antibodies at the time they were recruited to the study.

Tom Wingfield, PhD, senior clinical lecturer at the Liverpool School of Tropical Medicine, said that given the high risk of SARS-CoV-2 infection for frontline NHS staff, it was “vital that we do all that we can to understand, predict, and prevent risk of SARS-CoV-2 amongst healthcare workers”.

The study will continue to follow participants for 12 months to explore how long any immunity may last, the effectiveness of vaccines, and to what extent people with immunity are able to carry and transmit the virus.

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

Infection with the SARS-CoV-2 virus may provide some immunity for at least 5 months, interim results from a study has found.

The first report from the Sarscov2 Immunity & Reinfection Evaluation (SIREN) study suggested that antibodies from people who had recovered from COVID-19 gave at least 83% protection against reinfection compared with people who had not had the disease before.

However, Public Health England (PHE) researchers said some people with antibodies may still be able to carry and transmit the SARS-CoV-2 virus.

‘Strongly encouraged’

Susan Hopkins, PhD, senior medical advisor at PHE, who is leading the study, said the overall findings were good news. She told a briefing hosted by the Science Media Centre: “I am strongly encouraged that people have immunity that is lasting much more than the few months that was speculated before the summer.”

She added: “It allows people to feel that their prior infection will protect them from future infections but at the same time it is not complete protection, and therefore they still need to be careful when they are out and about.”

PHE scientists said they would continue to assess whether protection might last longer than 5 months.

Eleanor Riley, PhD, professor of immunology and infectious disease at the University of Edinburgh, said the report suggested that “natural infection provides short-term protection against COVID-19 that is very similar to that conferred by vaccination.”

Simon Clarke, PhD, associate professor in cellular microbiology at the University of Reading, said: “The concerning finding is that some people who have COVID antibodies appear to still be able to carry the coronavirus and could spread it to others. This means that the vast majority of the population will either need to have natural immunity or have been immunised for us to fully lift restrictions on our lives.”

The analysis took place before the new variant of SARS-CoV-2 became widespread in the UK. The PHE scientists said that further work was underway to establish whether and to what extent antibodies also provide protection from the VOC202012/01 variant.

Healthcare Workers

The SIREN preprint analysed data from 20,787 health care workers from 102 NHS trusts who had undergone antibody and PCR testing from June 18 to November 9, 2020.

Of those, 6614 tested positive for COVID-19 antibodies.

Of the 44 potential reinfections identified, two were designated ‘probable’ and 42 ‘possible’, based on available evidence.

Both of the two individuals classified as probable reinfections reported having experienced COVID-19 symptoms during the first wave of the pandemic but were not tested at the time. Both reported that their symptoms were less severe the second time.

None of the 44 potential reinfection cases were PCR tested during the first wave, but all tested positive for COVID-19 antibodies at the time they were recruited to the study.

Tom Wingfield, PhD, senior clinical lecturer at the Liverpool School of Tropical Medicine, said that given the high risk of SARS-CoV-2 infection for frontline NHS staff, it was “vital that we do all that we can to understand, predict, and prevent risk of SARS-CoV-2 amongst healthcare workers”.

The study will continue to follow participants for 12 months to explore how long any immunity may last, the effectiveness of vaccines, and to what extent people with immunity are able to carry and transmit the virus.

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

Infection with the SARS-CoV-2 virus may provide some immunity for at least 5 months, interim results from a study has found.

The first report from the Sarscov2 Immunity & Reinfection Evaluation (SIREN) study suggested that antibodies from people who had recovered from COVID-19 gave at least 83% protection against reinfection compared with people who had not had the disease before.

However, Public Health England (PHE) researchers said some people with antibodies may still be able to carry and transmit the SARS-CoV-2 virus.

‘Strongly encouraged’

Susan Hopkins, PhD, senior medical advisor at PHE, who is leading the study, said the overall findings were good news. She told a briefing hosted by the Science Media Centre: “I am strongly encouraged that people have immunity that is lasting much more than the few months that was speculated before the summer.”

She added: “It allows people to feel that their prior infection will protect them from future infections but at the same time it is not complete protection, and therefore they still need to be careful when they are out and about.”

PHE scientists said they would continue to assess whether protection might last longer than 5 months.

Eleanor Riley, PhD, professor of immunology and infectious disease at the University of Edinburgh, said the report suggested that “natural infection provides short-term protection against COVID-19 that is very similar to that conferred by vaccination.”

Simon Clarke, PhD, associate professor in cellular microbiology at the University of Reading, said: “The concerning finding is that some people who have COVID antibodies appear to still be able to carry the coronavirus and could spread it to others. This means that the vast majority of the population will either need to have natural immunity or have been immunised for us to fully lift restrictions on our lives.”

The analysis took place before the new variant of SARS-CoV-2 became widespread in the UK. The PHE scientists said that further work was underway to establish whether and to what extent antibodies also provide protection from the VOC202012/01 variant.

Healthcare Workers

The SIREN preprint analysed data from 20,787 health care workers from 102 NHS trusts who had undergone antibody and PCR testing from June 18 to November 9, 2020.

Of those, 6614 tested positive for COVID-19 antibodies.

Of the 44 potential reinfections identified, two were designated ‘probable’ and 42 ‘possible’, based on available evidence.

Both of the two individuals classified as probable reinfections reported having experienced COVID-19 symptoms during the first wave of the pandemic but were not tested at the time. Both reported that their symptoms were less severe the second time.

None of the 44 potential reinfection cases were PCR tested during the first wave, but all tested positive for COVID-19 antibodies at the time they were recruited to the study.

Tom Wingfield, PhD, senior clinical lecturer at the Liverpool School of Tropical Medicine, said that given the high risk of SARS-CoV-2 infection for frontline NHS staff, it was “vital that we do all that we can to understand, predict, and prevent risk of SARS-CoV-2 amongst healthcare workers”.

The study will continue to follow participants for 12 months to explore how long any immunity may last, the effectiveness of vaccines, and to what extent people with immunity are able to carry and transmit the virus.

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

Antibody response to the SARS-CoV-2 virus wanes over time, latest research has suggested.

An ongoing study led by Imperial College London (ICL) found that the proportion of people testing positive for COVID-19 antibodies dropped by 26.5% over a 3-month period between June and September.

The findings from a non–peer reviewed preprint suggested that infection with SARS-CoV-2 confers only limited protection against reinfection.

Professor Paul Elliott, director of the REACT-2 programme at ICL, said: “Testing positive for antibodies does not mean you are immune to COVID-19.

“It remains unclear what level of immunity antibodies provide, or for how long this immunity lasts.”

Experts said that, while the findings suggested that immunity might fade over time, the severity of illness from further infections could be reduced.
 

Antibody prevalence declined in all adults

Results from cross-sectional studies over the 3-month period involved 365,104 adults who self-administered a lateral flow immunoassay test.

There were 17,576 positive tests over the three rounds.

Antibody prevalence, adjusted for test characteristics and weighted to the adult population of England, declined from 6.0% to 4.4%, a reduction of 26.5% over the 3 months.

The decline was seen in all age groups. However, the lowest prevalence of a positive test, and the largest fall, was seen in those aged 75 years and older.

No change was seen in positive antibody tests in health care workers over the 3 months.

The results suggested that people who did not show symptoms of COVID-19 were more likely to lose detectable antibodies sooner than those who did show symptoms.

Prof Helen Ward, one of the lead authors of the report said that, while it was clear that the proportion of people with antibodies was falling over time, “We don’t yet know whether this will leave these people at risk of reinfection with the virus that causes COVID-19, but it is essential that everyone continues to follow guidance to reduce the risk to themselves and others.”
 

Results ‘weaken argument for herd immunity’

Commenting on the results to the Science Media Centre, Rowland Kao, professor of veterinary epidemiology and data science at the University of Edinburgh, warned that, if the results were correct, “any strategy that relies on ‘herd immunity’ lacks credibility.”

However, he added that, “while the decline is substantial, nevertheless substantial proportions of the population do retain some immune response, over 4 months after the peak of the epidemic”.

Eleanor Riley, professor of immunology and infectious disease, also from the University of Edinburgh, said it was too early to assume that immunity to SARS-CoV-2 did not last because “the study does not look at antibody concentrations, antibody function, or other aspects of immunity such as T-cell immunity and does not look at the trajectory of antibody levels in the same individuals over time”.

However, she said the findings did not mean that a vaccine would be ineffective because vaccines contained adjuvants that could induce durable immune responses, particularly with multiple immunizations.

“What is not clear is how quickly antibody levels would rise again if a person encounters the SARS-CoV-2 virus a second time. It is possible they will still rapidly respond, and either have a milder illness, or remain protected through immune memory,” commented Dr. Alexander Edwards, associate professor in biomedical technology at the University of Reading.

Health Minister Lord Bethell said: “Regardless of the result of an antibody test, everyone must continue to comply with government guidelines including social distancing, self-isolating, and getting a test if you have symptoms, and always remember: hands, face, space.”
 

This article first appeared on Medscape.com.

Antibody response to the SARS-CoV-2 virus wanes over time, latest research has suggested.

An ongoing study led by Imperial College London (ICL) found that the proportion of people testing positive for COVID-19 antibodies dropped by 26.5% over a 3-month period between June and September.

The findings from a non–peer reviewed preprint suggested that infection with SARS-CoV-2 confers only limited protection against reinfection.

Professor Paul Elliott, director of the REACT-2 programme at ICL, said: “Testing positive for antibodies does not mean you are immune to COVID-19.

“It remains unclear what level of immunity antibodies provide, or for how long this immunity lasts.”

Experts said that, while the findings suggested that immunity might fade over time, the severity of illness from further infections could be reduced.
 

Antibody prevalence declined in all adults

Results from cross-sectional studies over the 3-month period involved 365,104 adults who self-administered a lateral flow immunoassay test.

There were 17,576 positive tests over the three rounds.

Antibody prevalence, adjusted for test characteristics and weighted to the adult population of England, declined from 6.0% to 4.4%, a reduction of 26.5% over the 3 months.

The decline was seen in all age groups. However, the lowest prevalence of a positive test, and the largest fall, was seen in those aged 75 years and older.

No change was seen in positive antibody tests in health care workers over the 3 months.

The results suggested that people who did not show symptoms of COVID-19 were more likely to lose detectable antibodies sooner than those who did show symptoms.

Prof Helen Ward, one of the lead authors of the report said that, while it was clear that the proportion of people with antibodies was falling over time, “We don’t yet know whether this will leave these people at risk of reinfection with the virus that causes COVID-19, but it is essential that everyone continues to follow guidance to reduce the risk to themselves and others.”
 

Results ‘weaken argument for herd immunity’

Commenting on the results to the Science Media Centre, Rowland Kao, professor of veterinary epidemiology and data science at the University of Edinburgh, warned that, if the results were correct, “any strategy that relies on ‘herd immunity’ lacks credibility.”

However, he added that, “while the decline is substantial, nevertheless substantial proportions of the population do retain some immune response, over 4 months after the peak of the epidemic”.

Eleanor Riley, professor of immunology and infectious disease, also from the University of Edinburgh, said it was too early to assume that immunity to SARS-CoV-2 did not last because “the study does not look at antibody concentrations, antibody function, or other aspects of immunity such as T-cell immunity and does not look at the trajectory of antibody levels in the same individuals over time”.

However, she said the findings did not mean that a vaccine would be ineffective because vaccines contained adjuvants that could induce durable immune responses, particularly with multiple immunizations.

“What is not clear is how quickly antibody levels would rise again if a person encounters the SARS-CoV-2 virus a second time. It is possible they will still rapidly respond, and either have a milder illness, or remain protected through immune memory,” commented Dr. Alexander Edwards, associate professor in biomedical technology at the University of Reading.

Health Minister Lord Bethell said: “Regardless of the result of an antibody test, everyone must continue to comply with government guidelines including social distancing, self-isolating, and getting a test if you have symptoms, and always remember: hands, face, space.”
 

This article first appeared on Medscape.com.

Antibody response to the SARS-CoV-2 virus wanes over time, latest research has suggested.

An ongoing study led by Imperial College London (ICL) found that the proportion of people testing positive for COVID-19 antibodies dropped by 26.5% over a 3-month period between June and September.

The findings from a non–peer reviewed preprint suggested that infection with SARS-CoV-2 confers only limited protection against reinfection.

Professor Paul Elliott, director of the REACT-2 programme at ICL, said: “Testing positive for antibodies does not mean you are immune to COVID-19.

“It remains unclear what level of immunity antibodies provide, or for how long this immunity lasts.”

Experts said that, while the findings suggested that immunity might fade over time, the severity of illness from further infections could be reduced.
 

Antibody prevalence declined in all adults

Results from cross-sectional studies over the 3-month period involved 365,104 adults who self-administered a lateral flow immunoassay test.

There were 17,576 positive tests over the three rounds.

Antibody prevalence, adjusted for test characteristics and weighted to the adult population of England, declined from 6.0% to 4.4%, a reduction of 26.5% over the 3 months.

The decline was seen in all age groups. However, the lowest prevalence of a positive test, and the largest fall, was seen in those aged 75 years and older.

No change was seen in positive antibody tests in health care workers over the 3 months.

The results suggested that people who did not show symptoms of COVID-19 were more likely to lose detectable antibodies sooner than those who did show symptoms.

Prof Helen Ward, one of the lead authors of the report said that, while it was clear that the proportion of people with antibodies was falling over time, “We don’t yet know whether this will leave these people at risk of reinfection with the virus that causes COVID-19, but it is essential that everyone continues to follow guidance to reduce the risk to themselves and others.”
 

Results ‘weaken argument for herd immunity’

Commenting on the results to the Science Media Centre, Rowland Kao, professor of veterinary epidemiology and data science at the University of Edinburgh, warned that, if the results were correct, “any strategy that relies on ‘herd immunity’ lacks credibility.”

However, he added that, “while the decline is substantial, nevertheless substantial proportions of the population do retain some immune response, over 4 months after the peak of the epidemic”.

Eleanor Riley, professor of immunology and infectious disease, also from the University of Edinburgh, said it was too early to assume that immunity to SARS-CoV-2 did not last because “the study does not look at antibody concentrations, antibody function, or other aspects of immunity such as T-cell immunity and does not look at the trajectory of antibody levels in the same individuals over time”.

However, she said the findings did not mean that a vaccine would be ineffective because vaccines contained adjuvants that could induce durable immune responses, particularly with multiple immunizations.

“What is not clear is how quickly antibody levels would rise again if a person encounters the SARS-CoV-2 virus a second time. It is possible they will still rapidly respond, and either have a milder illness, or remain protected through immune memory,” commented Dr. Alexander Edwards, associate professor in biomedical technology at the University of Reading.

Health Minister Lord Bethell said: “Regardless of the result of an antibody test, everyone must continue to comply with government guidelines including social distancing, self-isolating, and getting a test if you have symptoms, and always remember: hands, face, space.”
 

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.