Key clinical point: Red blood cell transfusion independence (TI) among patients with myelodysplastic syndrome (MDS) was associated with longer overall survival and lower risk for acute myeloid leukemia (AML) progression.

Major finding: Risk of death was 61.8% (hazard ratio [HR], 0.382; 95% credible interval [CrI], 0.201-0.666) lower in patients with TI vs. transfusion dependence (TD) and 63.4% (HR, 0.366; 95% CrI, 0.217-0.553) lower in patients who acquired TI through treatment vs. those who did not. Patients with TD vs. TI showed a trend toward worse prognosis and higher risk for AML progression (HR, 0.754; 95% CrI, 0.311-1.811).

Study details: Findings are from a meta-analysis of pooled studies that estimated the effect of transfusion sensitivity on clinical outcomes in patients with MDS.

Disclosures: The study was supported by Bristol-Myers Squibb Company. D Tang reported being an employee and equity holder of Bristol-Myers Squibb. T Schroeder reported being a consultant for Celgene International, a Bristol-Myers Squibb Company. The other authors declared no conflicts of interest.

Source: Lemos MB et al. Eur J Haematol. 2021 Mar 14. doi: 10.1111/ejh.13619.

Key clinical point: Red blood cell transfusion independence (TI) among patients with myelodysplastic syndrome (MDS) was associated with longer overall survival and lower risk for acute myeloid leukemia (AML) progression.

Major finding: Risk of death was 61.8% (hazard ratio [HR], 0.382; 95% credible interval [CrI], 0.201-0.666) lower in patients with TI vs. transfusion dependence (TD) and 63.4% (HR, 0.366; 95% CrI, 0.217-0.553) lower in patients who acquired TI through treatment vs. those who did not. Patients with TD vs. TI showed a trend toward worse prognosis and higher risk for AML progression (HR, 0.754; 95% CrI, 0.311-1.811).

Study details: Findings are from a meta-analysis of pooled studies that estimated the effect of transfusion sensitivity on clinical outcomes in patients with MDS.

Disclosures: The study was supported by Bristol-Myers Squibb Company. D Tang reported being an employee and equity holder of Bristol-Myers Squibb. T Schroeder reported being a consultant for Celgene International, a Bristol-Myers Squibb Company. The other authors declared no conflicts of interest.

Source: Lemos MB et al. Eur J Haematol. 2021 Mar 14. doi: 10.1111/ejh.13619.

Key clinical point: Red blood cell transfusion independence (TI) among patients with myelodysplastic syndrome (MDS) was associated with longer overall survival and lower risk for acute myeloid leukemia (AML) progression.

Major finding: Risk of death was 61.8% (hazard ratio [HR], 0.382; 95% credible interval [CrI], 0.201-0.666) lower in patients with TI vs. transfusion dependence (TD) and 63.4% (HR, 0.366; 95% CrI, 0.217-0.553) lower in patients who acquired TI through treatment vs. those who did not. Patients with TD vs. TI showed a trend toward worse prognosis and higher risk for AML progression (HR, 0.754; 95% CrI, 0.311-1.811).

Study details: Findings are from a meta-analysis of pooled studies that estimated the effect of transfusion sensitivity on clinical outcomes in patients with MDS.

Disclosures: The study was supported by Bristol-Myers Squibb Company. D Tang reported being an employee and equity holder of Bristol-Myers Squibb. T Schroeder reported being a consultant for Celgene International, a Bristol-Myers Squibb Company. The other authors declared no conflicts of interest.

Source: Lemos MB et al. Eur J Haematol. 2021 Mar 14. doi: 10.1111/ejh.13619.

More than 10 years after the withdrawal of the weight-loss drug Mediator (benfluorex) from the market in France, the Paris Court issued its judgment on March 29, 2021, against Servier Laboratories and the French National Agency for the Safety of Medicines and Health Products (ANSM).

Servier Laboratories was convicted of “aggravated deception” and fined 2.7 million euros (approximately $3.2 million) but were found not guilty of fraud. ANSM will also have to pay a fine.

Mediator was brought to the market in 1976 for the treatment of hyperlipidemia and for overweight patients with type 2 diabetes but was used off label as an appetite suppressant. It was taken by 5 million people and was only removed from the market in France in 2009 because of its toxic effects.

Mediator was taken off the market in Spain 6 years earlier, and in Switzerland 12 years earlier, and more than 30 years before in Belgium. It was never marketed in the United States.

The number of deaths because of heart valve damage related to the drug in France has been estimated at 220-300 in the short term (2.5 years) and 1,300-1,800 in the long term. In addition, the drug has been responsible for 3,100-4,200 hospital admissions for valvular insufficiency and pulmonary arterial hypertension.

“Despite knowing the risks for very many years ... [Servier Laboratories] never took the necessary measures and thus deceived” consumers of Mediator, declared the president of the criminal court, Sylvie Daunois.

Servier has “weakened confidence in the health system,” she added.

“I am very happy that ‘aggravated deception,’ the heart of the case, has been recognized and condemned,” Irène Frachon, MD, a pulmonologist at Brest (France) University Hospital and whistleblower on the Mediator scandal, said in an interview.

However, Dr. Frachon continued: “The major problem, putting a toxic agent on the market for years, is a given. But the weakness of the sentences gives a mixed message.

“The judgment is too cautious in its punishments,” she added, pointing out that, “in the case of contaminated blood, there were prison sentences.”
 

Servier deceived doctors and patients

The French trial in September 2019 was extraordinary, with about 100 witnesses, nearly 400 lawyers, and 5,000 victims.

On June 23, 2020, the prosecutor, Aude Le Guilcher, requested at the end of her indictment that the six companies of the Servier group be fined, notably for “deception, homicide, involuntary injuries, and fraud,” to the tune of 20.3 million euros (approximately $23.8 million).

Against the former No. 2 of Servier, Jean-Philippe Seta, Ms. Le Guilcher requested 5 years in prison, with 2 years suspended, and a 200,000 euro (approximately $235,000) fine.

The same sum was requested against ANSM for homicide and unintentional injuries.

In the end, Mr. Seta, the former right hand of Jacques Servier, who died in 2004, was sentenced to 4 years in prison, suspended. For their part, ANSM was fined 303,000 euros(approximately $350,000).

It is now clearly established that Servier Laboratories knowingly concealed the similarity of Mediator to the fenfluramine family of compounds, which was banned in 1990 because of adverse effects.

The group also deceived doctors who prescribed the drug and patients who took it by hiding its toxicity.
 

Mediator should never have been authorized for use

In terms of the fraud charges, the prosecutor estimated that the losses incurred by the primary health insurance industry were in the region of several hundred million euros.

She argued that Mediator should never have been reimbursed, as “it should never have benefited from market authorization, which it received solely due to the fraudulent actions of the company.”

But because of the statute of limitations, this argument was not heard, explained Dr. Frachon, “and the same is true of conflicts of interest, where limitations led to them being discharged.

“We understand the legal difficulties, but it’s a shame in terms of the signal sent.”

“I hope the medical world will learn the lesson and not continue with ‘business as usual’ with people who are delinquents. I think it will be essential to restore public confidence,” concluded Dr. Frachon.

No conflicts of interest or funding were declared.

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

More than 10 years after the withdrawal of the weight-loss drug Mediator (benfluorex) from the market in France, the Paris Court issued its judgment on March 29, 2021, against Servier Laboratories and the French National Agency for the Safety of Medicines and Health Products (ANSM).

Servier Laboratories was convicted of “aggravated deception” and fined 2.7 million euros (approximately $3.2 million) but were found not guilty of fraud. ANSM will also have to pay a fine.

Mediator was brought to the market in 1976 for the treatment of hyperlipidemia and for overweight patients with type 2 diabetes but was used off label as an appetite suppressant. It was taken by 5 million people and was only removed from the market in France in 2009 because of its toxic effects.

Mediator was taken off the market in Spain 6 years earlier, and in Switzerland 12 years earlier, and more than 30 years before in Belgium. It was never marketed in the United States.

The number of deaths because of heart valve damage related to the drug in France has been estimated at 220-300 in the short term (2.5 years) and 1,300-1,800 in the long term. In addition, the drug has been responsible for 3,100-4,200 hospital admissions for valvular insufficiency and pulmonary arterial hypertension.

“Despite knowing the risks for very many years ... [Servier Laboratories] never took the necessary measures and thus deceived” consumers of Mediator, declared the president of the criminal court, Sylvie Daunois.

Servier has “weakened confidence in the health system,” she added.

“I am very happy that ‘aggravated deception,’ the heart of the case, has been recognized and condemned,” Irène Frachon, MD, a pulmonologist at Brest (France) University Hospital and whistleblower on the Mediator scandal, said in an interview.

However, Dr. Frachon continued: “The major problem, putting a toxic agent on the market for years, is a given. But the weakness of the sentences gives a mixed message.

“The judgment is too cautious in its punishments,” she added, pointing out that, “in the case of contaminated blood, there were prison sentences.”
 

Servier deceived doctors and patients

The French trial in September 2019 was extraordinary, with about 100 witnesses, nearly 400 lawyers, and 5,000 victims.

On June 23, 2020, the prosecutor, Aude Le Guilcher, requested at the end of her indictment that the six companies of the Servier group be fined, notably for “deception, homicide, involuntary injuries, and fraud,” to the tune of 20.3 million euros (approximately $23.8 million).

Against the former No. 2 of Servier, Jean-Philippe Seta, Ms. Le Guilcher requested 5 years in prison, with 2 years suspended, and a 200,000 euro (approximately $235,000) fine.

The same sum was requested against ANSM for homicide and unintentional injuries.

In the end, Mr. Seta, the former right hand of Jacques Servier, who died in 2004, was sentenced to 4 years in prison, suspended. For their part, ANSM was fined 303,000 euros(approximately $350,000).

It is now clearly established that Servier Laboratories knowingly concealed the similarity of Mediator to the fenfluramine family of compounds, which was banned in 1990 because of adverse effects.

The group also deceived doctors who prescribed the drug and patients who took it by hiding its toxicity.
 

Mediator should never have been authorized for use

In terms of the fraud charges, the prosecutor estimated that the losses incurred by the primary health insurance industry were in the region of several hundred million euros.

She argued that Mediator should never have been reimbursed, as “it should never have benefited from market authorization, which it received solely due to the fraudulent actions of the company.”

But because of the statute of limitations, this argument was not heard, explained Dr. Frachon, “and the same is true of conflicts of interest, where limitations led to them being discharged.

“We understand the legal difficulties, but it’s a shame in terms of the signal sent.”

“I hope the medical world will learn the lesson and not continue with ‘business as usual’ with people who are delinquents. I think it will be essential to restore public confidence,” concluded Dr. Frachon.

No conflicts of interest or funding were declared.

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

More than 10 years after the withdrawal of the weight-loss drug Mediator (benfluorex) from the market in France, the Paris Court issued its judgment on March 29, 2021, against Servier Laboratories and the French National Agency for the Safety of Medicines and Health Products (ANSM).

Servier Laboratories was convicted of “aggravated deception” and fined 2.7 million euros (approximately $3.2 million) but were found not guilty of fraud. ANSM will also have to pay a fine.

Mediator was brought to the market in 1976 for the treatment of hyperlipidemia and for overweight patients with type 2 diabetes but was used off label as an appetite suppressant. It was taken by 5 million people and was only removed from the market in France in 2009 because of its toxic effects.

Mediator was taken off the market in Spain 6 years earlier, and in Switzerland 12 years earlier, and more than 30 years before in Belgium. It was never marketed in the United States.

The number of deaths because of heart valve damage related to the drug in France has been estimated at 220-300 in the short term (2.5 years) and 1,300-1,800 in the long term. In addition, the drug has been responsible for 3,100-4,200 hospital admissions for valvular insufficiency and pulmonary arterial hypertension.

“Despite knowing the risks for very many years ... [Servier Laboratories] never took the necessary measures and thus deceived” consumers of Mediator, declared the president of the criminal court, Sylvie Daunois.

Servier has “weakened confidence in the health system,” she added.

“I am very happy that ‘aggravated deception,’ the heart of the case, has been recognized and condemned,” Irène Frachon, MD, a pulmonologist at Brest (France) University Hospital and whistleblower on the Mediator scandal, said in an interview.

However, Dr. Frachon continued: “The major problem, putting a toxic agent on the market for years, is a given. But the weakness of the sentences gives a mixed message.

“The judgment is too cautious in its punishments,” she added, pointing out that, “in the case of contaminated blood, there were prison sentences.”
 

Servier deceived doctors and patients

The French trial in September 2019 was extraordinary, with about 100 witnesses, nearly 400 lawyers, and 5,000 victims.

On June 23, 2020, the prosecutor, Aude Le Guilcher, requested at the end of her indictment that the six companies of the Servier group be fined, notably for “deception, homicide, involuntary injuries, and fraud,” to the tune of 20.3 million euros (approximately $23.8 million).

Against the former No. 2 of Servier, Jean-Philippe Seta, Ms. Le Guilcher requested 5 years in prison, with 2 years suspended, and a 200,000 euro (approximately $235,000) fine.

The same sum was requested against ANSM for homicide and unintentional injuries.

In the end, Mr. Seta, the former right hand of Jacques Servier, who died in 2004, was sentenced to 4 years in prison, suspended. For their part, ANSM was fined 303,000 euros(approximately $350,000).

It is now clearly established that Servier Laboratories knowingly concealed the similarity of Mediator to the fenfluramine family of compounds, which was banned in 1990 because of adverse effects.

The group also deceived doctors who prescribed the drug and patients who took it by hiding its toxicity.
 

Mediator should never have been authorized for use

In terms of the fraud charges, the prosecutor estimated that the losses incurred by the primary health insurance industry were in the region of several hundred million euros.

She argued that Mediator should never have been reimbursed, as “it should never have benefited from market authorization, which it received solely due to the fraudulent actions of the company.”

But because of the statute of limitations, this argument was not heard, explained Dr. Frachon, “and the same is true of conflicts of interest, where limitations led to them being discharged.

“We understand the legal difficulties, but it’s a shame in terms of the signal sent.”

“I hope the medical world will learn the lesson and not continue with ‘business as usual’ with people who are delinquents. I think it will be essential to restore public confidence,” concluded Dr. Frachon.

No conflicts of interest or funding were declared.

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

Patients at very high risk for melanoma, including those with a family history or with inherited pathogenic variants of genes that increase the risk, likely benefit from routine whole-body screening for melanoma and education about UV protection.

Those are key findings from the first prospective cohort study to quantify the benefit of screening in melanoma-prone families, which was published online April 2 in Cancer Epidemiology, Biomarkers & Prevention.

“Whole-body screening for melanoma is currently routine for individuals at high risk for melanoma, which includes people from melanoma-prone families (at least two relatives who have had melanoma) and those with inherited pathogenic gene variants of the CDKN2A or CDK4 genes, which increase risk for melanoma,” lead author Michael R. Sargen, MD, said in an interview. “In our study, we investigated whether screening and educational interventions, including education about the appearance of melanoma and strategies for protecting skin from ultraviolet damage, contributed to early diagnosis of melanoma in individuals from melanoma-prone families.”

Of the 293 individuals who enrolled in the study between 1976 and 2014, 246 were diagnosed with melanoma before enrollment (the prestudy cohort) and 47 were diagnosed after enrollment (the prospective cohort). The researchers compared differences in melanoma thickness and tumor stage between participants in the prestudy and prospective cohorts, and compared tumor-thickness trends between participants in their study and cases in the general population using data from Surveillance, Epidemiology, and End Results (SEER) registries between 1973 and 2016. Because information on melanoma thickness was missing for 24% of melanoma cases in the NCI Familial Melanoma Study and 8.7% of melanoma cases found in the SEER registry, the researchers imputed the missing data.

After adjusting for gender and age, Dr. Sargen and his colleagues found that participants in the prospective cohort had significantly thinner melanomas, compared with those in the prestudy cohort (0.6 mm vs. 1.1 mm, respectively; P < .001). In addition, 83% of those in the prospective cohort were significantly more likely to be diagnosed at the early T1 stage, compared with 40% of those in the prestudy cohort (P < .001).

In their analysis, they also determined that after adjusting for gender and age, “all NCI family cases had systematically lower thickness than SEER cases during the study period.” The reductions in melanoma thickness and tumor stage, they concluded, “were not fully explained by calendar period effects of decreasing thickness in the general population and point to the potential benefit of skin cancer screening for patients with a family history of melanoma and those with pathogenic germline variants of melanoma-susceptibility genes.”

“Our data provide reassuring evidence that screening, alongside education about proper UV protection and the appearance of melanoma, is likely benefiting patients with a significantly elevated risk for melanoma,” Dr. Sargen said in the interview “Further studies are needed to determine whether individuals without a family history of melanoma may benefit from whole-body screening, and whether the benefits vary by ethnicity.”

He acknowledged certain limitations of the study, including the relatively small sample size of melanoma cases in the NCI Familial Melanoma Study and the imputation of missing melanoma-thickness data. “Additionally, since this was a prospective cohort study, we were not able to distinguish the independent effect of each intervention,” he said. “Randomized controlled studies are needed to understand the impact of each aspect of the intervention, such as whole-body screening, melanoma education, or strategies for skin protection.”

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard University, Boston, called the analysis “well done,” but commented on the potential role of selection bias impacting the findings. “People who have a strong family history of melanoma and who are opting to engage in an NCI study and come in for full-body skin checks and go through that education process may have very different health-seeking behaviors than individuals in the general population that would be reported to SEER,” she said.

She also raised the question of whether the results were driven by the early detection through the NCI’s program of provider screening or through the educational component that enables earlier self-detection. “If you’re an individual involved in a study and that brings attention to your moles and you have a strong family history of melanoma to begin with, it is not surprising that you are going to have heightened awareness of any changing mole and therefore are more likely to have melanoma detected at an earlier stage,” Dr. Asgari said.

The study was supported by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute. Dr. Sargen reported having no financial disclosures.
Dr. Asgari disclosed that she has received research support from the Melanoma Research Alliance.
 

[email protected]

Patients at very high risk for melanoma, including those with a family history or with inherited pathogenic variants of genes that increase the risk, likely benefit from routine whole-body screening for melanoma and education about UV protection.

Those are key findings from the first prospective cohort study to quantify the benefit of screening in melanoma-prone families, which was published online April 2 in Cancer Epidemiology, Biomarkers & Prevention.

“Whole-body screening for melanoma is currently routine for individuals at high risk for melanoma, which includes people from melanoma-prone families (at least two relatives who have had melanoma) and those with inherited pathogenic gene variants of the CDKN2A or CDK4 genes, which increase risk for melanoma,” lead author Michael R. Sargen, MD, said in an interview. “In our study, we investigated whether screening and educational interventions, including education about the appearance of melanoma and strategies for protecting skin from ultraviolet damage, contributed to early diagnosis of melanoma in individuals from melanoma-prone families.”

Of the 293 individuals who enrolled in the study between 1976 and 2014, 246 were diagnosed with melanoma before enrollment (the prestudy cohort) and 47 were diagnosed after enrollment (the prospective cohort). The researchers compared differences in melanoma thickness and tumor stage between participants in the prestudy and prospective cohorts, and compared tumor-thickness trends between participants in their study and cases in the general population using data from Surveillance, Epidemiology, and End Results (SEER) registries between 1973 and 2016. Because information on melanoma thickness was missing for 24% of melanoma cases in the NCI Familial Melanoma Study and 8.7% of melanoma cases found in the SEER registry, the researchers imputed the missing data.

After adjusting for gender and age, Dr. Sargen and his colleagues found that participants in the prospective cohort had significantly thinner melanomas, compared with those in the prestudy cohort (0.6 mm vs. 1.1 mm, respectively; P < .001). In addition, 83% of those in the prospective cohort were significantly more likely to be diagnosed at the early T1 stage, compared with 40% of those in the prestudy cohort (P < .001).

In their analysis, they also determined that after adjusting for gender and age, “all NCI family cases had systematically lower thickness than SEER cases during the study period.” The reductions in melanoma thickness and tumor stage, they concluded, “were not fully explained by calendar period effects of decreasing thickness in the general population and point to the potential benefit of skin cancer screening for patients with a family history of melanoma and those with pathogenic germline variants of melanoma-susceptibility genes.”

“Our data provide reassuring evidence that screening, alongside education about proper UV protection and the appearance of melanoma, is likely benefiting patients with a significantly elevated risk for melanoma,” Dr. Sargen said in the interview “Further studies are needed to determine whether individuals without a family history of melanoma may benefit from whole-body screening, and whether the benefits vary by ethnicity.”

He acknowledged certain limitations of the study, including the relatively small sample size of melanoma cases in the NCI Familial Melanoma Study and the imputation of missing melanoma-thickness data. “Additionally, since this was a prospective cohort study, we were not able to distinguish the independent effect of each intervention,” he said. “Randomized controlled studies are needed to understand the impact of each aspect of the intervention, such as whole-body screening, melanoma education, or strategies for skin protection.”

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard University, Boston, called the analysis “well done,” but commented on the potential role of selection bias impacting the findings. “People who have a strong family history of melanoma and who are opting to engage in an NCI study and come in for full-body skin checks and go through that education process may have very different health-seeking behaviors than individuals in the general population that would be reported to SEER,” she said.

She also raised the question of whether the results were driven by the early detection through the NCI’s program of provider screening or through the educational component that enables earlier self-detection. “If you’re an individual involved in a study and that brings attention to your moles and you have a strong family history of melanoma to begin with, it is not surprising that you are going to have heightened awareness of any changing mole and therefore are more likely to have melanoma detected at an earlier stage,” Dr. Asgari said.

The study was supported by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute. Dr. Sargen reported having no financial disclosures.
Dr. Asgari disclosed that she has received research support from the Melanoma Research Alliance.
 

[email protected]

Patients at very high risk for melanoma, including those with a family history or with inherited pathogenic variants of genes that increase the risk, likely benefit from routine whole-body screening for melanoma and education about UV protection.

Those are key findings from the first prospective cohort study to quantify the benefit of screening in melanoma-prone families, which was published online April 2 in Cancer Epidemiology, Biomarkers & Prevention.

“Whole-body screening for melanoma is currently routine for individuals at high risk for melanoma, which includes people from melanoma-prone families (at least two relatives who have had melanoma) and those with inherited pathogenic gene variants of the CDKN2A or CDK4 genes, which increase risk for melanoma,” lead author Michael R. Sargen, MD, said in an interview. “In our study, we investigated whether screening and educational interventions, including education about the appearance of melanoma and strategies for protecting skin from ultraviolet damage, contributed to early diagnosis of melanoma in individuals from melanoma-prone families.”

Of the 293 individuals who enrolled in the study between 1976 and 2014, 246 were diagnosed with melanoma before enrollment (the prestudy cohort) and 47 were diagnosed after enrollment (the prospective cohort). The researchers compared differences in melanoma thickness and tumor stage between participants in the prestudy and prospective cohorts, and compared tumor-thickness trends between participants in their study and cases in the general population using data from Surveillance, Epidemiology, and End Results (SEER) registries between 1973 and 2016. Because information on melanoma thickness was missing for 24% of melanoma cases in the NCI Familial Melanoma Study and 8.7% of melanoma cases found in the SEER registry, the researchers imputed the missing data.

After adjusting for gender and age, Dr. Sargen and his colleagues found that participants in the prospective cohort had significantly thinner melanomas, compared with those in the prestudy cohort (0.6 mm vs. 1.1 mm, respectively; P < .001). In addition, 83% of those in the prospective cohort were significantly more likely to be diagnosed at the early T1 stage, compared with 40% of those in the prestudy cohort (P < .001).

In their analysis, they also determined that after adjusting for gender and age, “all NCI family cases had systematically lower thickness than SEER cases during the study period.” The reductions in melanoma thickness and tumor stage, they concluded, “were not fully explained by calendar period effects of decreasing thickness in the general population and point to the potential benefit of skin cancer screening for patients with a family history of melanoma and those with pathogenic germline variants of melanoma-susceptibility genes.”

“Our data provide reassuring evidence that screening, alongside education about proper UV protection and the appearance of melanoma, is likely benefiting patients with a significantly elevated risk for melanoma,” Dr. Sargen said in the interview “Further studies are needed to determine whether individuals without a family history of melanoma may benefit from whole-body screening, and whether the benefits vary by ethnicity.”

He acknowledged certain limitations of the study, including the relatively small sample size of melanoma cases in the NCI Familial Melanoma Study and the imputation of missing melanoma-thickness data. “Additionally, since this was a prospective cohort study, we were not able to distinguish the independent effect of each intervention,” he said. “Randomized controlled studies are needed to understand the impact of each aspect of the intervention, such as whole-body screening, melanoma education, or strategies for skin protection.”

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard University, Boston, called the analysis “well done,” but commented on the potential role of selection bias impacting the findings. “People who have a strong family history of melanoma and who are opting to engage in an NCI study and come in for full-body skin checks and go through that education process may have very different health-seeking behaviors than individuals in the general population that would be reported to SEER,” she said.

She also raised the question of whether the results were driven by the early detection through the NCI’s program of provider screening or through the educational component that enables earlier self-detection. “If you’re an individual involved in a study and that brings attention to your moles and you have a strong family history of melanoma to begin with, it is not surprising that you are going to have heightened awareness of any changing mole and therefore are more likely to have melanoma detected at an earlier stage,” Dr. Asgari said.

The study was supported by the Intramural Research Program of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute. Dr. Sargen reported having no financial disclosures.
Dr. Asgari disclosed that she has received research support from the Melanoma Research Alliance.
 

[email protected]

Key clinical point: Oral azacitidine (CC-486) was associated with a significantly higher red blood cell (RBC) transfusion independence (TI) rate in patients with low-risk myelodysplastic syndrome (MDS) and high-risk disease features. The rate of early death was higher in the CC-846 arm.

Major finding: A significantly higher proportion of patients achieved RBC TI for 56 consecutive days in CC-486 vs. placebo arms (30.8% vs. 11.1%; odds ratio, 3.6; P = .0002). Overall, the death rate was similar, but death within the first 56 days was higher with CC-486 vs. placebo (16 vs. 6), most related to infections in patients with significant pretreatment neutropenia.

Study details: Findings are from AZA-MDS-003, a phase 3 trial involving 216 patients with low-risk MDS and RBC transfusion-dependent anemia and thrombocytopenia who were randomly allocated to either CC-486 (n=107) or placebo (n=109) for 21 days/28-day cycle.

Disclosures: The study was supported by Celgene Corporation, a Bristol-Myers Squibb company. Some of the authors declared receiving research funding, honoraria, travel and accommodation expenses, consulting/advisory role, being an employee of and/or stock/other ownership interest in various pharmaceutical companies including Celgene.

Source: Garcia-Manero G et al. J Clin Oncol. 2021 Mar 25. doi: 10.1200/JCO.20.02619. 

Key clinical point: Oral azacitidine (CC-486) was associated with a significantly higher red blood cell (RBC) transfusion independence (TI) rate in patients with low-risk myelodysplastic syndrome (MDS) and high-risk disease features. The rate of early death was higher in the CC-846 arm.

Major finding: A significantly higher proportion of patients achieved RBC TI for 56 consecutive days in CC-486 vs. placebo arms (30.8% vs. 11.1%; odds ratio, 3.6; P = .0002). Overall, the death rate was similar, but death within the first 56 days was higher with CC-486 vs. placebo (16 vs. 6), most related to infections in patients with significant pretreatment neutropenia.

Study details: Findings are from AZA-MDS-003, a phase 3 trial involving 216 patients with low-risk MDS and RBC transfusion-dependent anemia and thrombocytopenia who were randomly allocated to either CC-486 (n=107) or placebo (n=109) for 21 days/28-day cycle.

Disclosures: The study was supported by Celgene Corporation, a Bristol-Myers Squibb company. Some of the authors declared receiving research funding, honoraria, travel and accommodation expenses, consulting/advisory role, being an employee of and/or stock/other ownership interest in various pharmaceutical companies including Celgene.

Source: Garcia-Manero G et al. J Clin Oncol. 2021 Mar 25. doi: 10.1200/JCO.20.02619. 

Key clinical point: Oral azacitidine (CC-486) was associated with a significantly higher red blood cell (RBC) transfusion independence (TI) rate in patients with low-risk myelodysplastic syndrome (MDS) and high-risk disease features. The rate of early death was higher in the CC-846 arm.

Major finding: A significantly higher proportion of patients achieved RBC TI for 56 consecutive days in CC-486 vs. placebo arms (30.8% vs. 11.1%; odds ratio, 3.6; P = .0002). Overall, the death rate was similar, but death within the first 56 days was higher with CC-486 vs. placebo (16 vs. 6), most related to infections in patients with significant pretreatment neutropenia.

Study details: Findings are from AZA-MDS-003, a phase 3 trial involving 216 patients with low-risk MDS and RBC transfusion-dependent anemia and thrombocytopenia who were randomly allocated to either CC-486 (n=107) or placebo (n=109) for 21 days/28-day cycle.

Disclosures: The study was supported by Celgene Corporation, a Bristol-Myers Squibb company. Some of the authors declared receiving research funding, honoraria, travel and accommodation expenses, consulting/advisory role, being an employee of and/or stock/other ownership interest in various pharmaceutical companies including Celgene.

Source: Garcia-Manero G et al. J Clin Oncol. 2021 Mar 25. doi: 10.1200/JCO.20.02619. 

The Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial hypercholesterolemia, the agency announced.

The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was originally approved in the United States in 2015 as an adjunct to diet, alone or in combination with other lipid-lowering therapies, to reduce LDL cholesterol in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (FH).

Heterozygous FH is one of the most common genetic disorders, affecting 1 in every 200-500 people worldwide, whereas homozygous FH is very rare, affecting about 1 in 1 million people worldwide.

Alirocumab is also approved to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with cardiovascular disease.

The new indication is based on a 12-week randomized trial in 45 adults who received 150 mg alirocumab every 2 weeks and 24 patients who received placebo, both on top of other therapies to reduce LDL cholesterol. At week 12, patients receiving alirocumab had an average 27% decrease in LDL cholesterol, compared with an average 9% increase among patients on placebo.

Common side effects of alirocumab are nasopharyngitis, injection-site reactions, and influenza. Serious hypersensitivity reactions have occurred among people taking alirocumab.

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

The Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial hypercholesterolemia, the agency announced.

The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was originally approved in the United States in 2015 as an adjunct to diet, alone or in combination with other lipid-lowering therapies, to reduce LDL cholesterol in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (FH).

Heterozygous FH is one of the most common genetic disorders, affecting 1 in every 200-500 people worldwide, whereas homozygous FH is very rare, affecting about 1 in 1 million people worldwide.

Alirocumab is also approved to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with cardiovascular disease.

The new indication is based on a 12-week randomized trial in 45 adults who received 150 mg alirocumab every 2 weeks and 24 patients who received placebo, both on top of other therapies to reduce LDL cholesterol. At week 12, patients receiving alirocumab had an average 27% decrease in LDL cholesterol, compared with an average 9% increase among patients on placebo.

Common side effects of alirocumab are nasopharyngitis, injection-site reactions, and influenza. Serious hypersensitivity reactions have occurred among people taking alirocumab.

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

The Food and Drug Administration has approved alirocumab (Praluent, Regeneron Pharmaceuticals) injection as add-on therapy for adults with homozygous familial hypercholesterolemia, the agency announced.

The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was originally approved in the United States in 2015 as an adjunct to diet, alone or in combination with other lipid-lowering therapies, to reduce LDL cholesterol in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (FH).

Heterozygous FH is one of the most common genetic disorders, affecting 1 in every 200-500 people worldwide, whereas homozygous FH is very rare, affecting about 1 in 1 million people worldwide.

Alirocumab is also approved to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with cardiovascular disease.

The new indication is based on a 12-week randomized trial in 45 adults who received 150 mg alirocumab every 2 weeks and 24 patients who received placebo, both on top of other therapies to reduce LDL cholesterol. At week 12, patients receiving alirocumab had an average 27% decrease in LDL cholesterol, compared with an average 9% increase among patients on placebo.

Common side effects of alirocumab are nasopharyngitis, injection-site reactions, and influenza. Serious hypersensitivity reactions have occurred among people taking alirocumab.

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

News of actor/comedian Pete Davidson expressing relief after finally receiving a diagnosis of borderline personality disorder (BPD) prompted a recent Twitter discussion among physicians regarding the ongoing debate on whether or not to tell a patient he or she has this diagnosis.

“I’ve heard from [many] trainees that they were told never to tell a patient they had BPD, but I can hardly think of anything more paternalistic and stigmatizing,” Amy Barnhorst, MD, vice chair of community psychiatry at University of California, Davis, tweeted.

“Most patients, when I explain it to them, have this kind of reaction – they feel relieved and understood,” she added.

“I was told that as well [not to tell] in one of my practicum placements,” one respondent who identified herself as a clinical/forensic psychologist tweeted back. “I said it anyway and the person was relieved there was a name for what they were living with.”

However, others disagreed with Dr. Barnhorst, noting that BPD is a very serious, stigmatizing, and challenging disorder to treat and, because of this, may cause patients to lose hope.

Still, Dr. Barnhorst stands by her position. Although “there is a negative stigma against a diagnosis of BPD,” that idea more often comes from the clinician instead of the patient, she said.

“I’ve never had a patient say, ‘how dare you call me that!’ like it was an insult,” she said in an interview. Not disclosing a diagnosis “is like you’re not trusting a patient to be a reasonable adult human about this.”
 

‘Hard diagnosis’

Although BPD is a “hard diagnosis, we would never withhold a diagnosis of cancer or liver disease or something else we knew patients didn’t want but that we were going to try and treat them for,” said Dr. Barnhorst.

BPD is linked to significant morbidity because of its common association with comorbid conditions, such as major depressive disorder, substance use disorders, and dysthymia. A history of self-harm is present in 70%-75% of these patients and some estimates suggest up to 9% of individuals with BPD die by suicide.

In an article published in Innovations in Clinical Neuroscience investigators discussed “ethical and clinical questions psychiatrists should consider” when treating BPD, including whether a diagnosis should be shared with a patient.

After such a diagnosis a patient may “react intensely in negative ways and these responses may be easily triggered,” the researchers wrote.

“A propensity that will likely cause psychiatrists anguish, however, is BPD patients’ increased likelihood of attempting suicide,” they added. Part of the problem has been that, in the past, it was thought that a BPD prognosis was untreatable. However, the researchers note that is no longer the case.

Still, Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis, has labeled BPD a so-called “asterisk” disorder.  

As she wrote in a recent blog, “We tell patients when they meet criteria for a medical diagnosis.* We show compassion and nonjudgmentalism to patients.* We do not discriminate against patients.*” However, the asterisk for each of these statements is: *Except for those with BPD.
 

Ongoing debate

Starting around the 1980s, the DSM listed personality disorders under the No. 2 Axis, which is for conditions with symptoms that are “not mitigatable,” said Dr. Nelson.

“It really started as well-meaning therapists who care about their patients who wanted to develop some precision in understanding people, and them starting to notice some patterns that can get in the way of optimal function,” she said in an interview.

The thought was not to disclose these diagnoses “because that was for you to understand, and for the patient to discover these patterns over time in the course of your work together,” Dr. Nelson added.

Although treatment for BPD used to be virtually nonexistent, there is now hope – especially with dialectic-behavior therapy (DBT), which uses mindfulness to teach patients how to control emotions and improve relationships.

According to the National Education Alliance for BPD, other useful treatments include mentalization-based therapy, transference-focused therapy, and “good psychiatric management.” Although there are currently no approved medications for BPD, some drugs are used to treat comorbid conditions such as depression or anxiety.

“We now know that people recover, and the whole paradigm has been turned on its head,” Dr. Nelson said. For example, “we no longer categorize these things as treatable or untreatable, which was a very positive move.”

So why is the field still debating the issue of diagnosis disclosure?

“To this day there are different psychiatrists and some medical school curricula that continue to teach that personality disorders are long-term, fixed, and nontreatable – and that it’s kind of disparaging to give this kind of diagnosis to a patient,” Dr. Nelson said.

Dr. Nelson, also the vice chair for education at the University of Minnesota, Minneapolis, medical school, reported that there “we acknowledge BPD’s painful history and that there are these misconceptions. They’re going to be on the front line of combating discrimination and the idea that if you see a patient with possible BPD coming you should run. That’s just unacceptable.”

Dr. Nelson noted that the idea of disclosing a BPD diagnosis is less controversial now than in the past, but “the whole thing is still under debate, and treatment guidelines [on BPD] are old and expired.”

Criteria for BPD were not updated when the DSM-5 was published in 2013, and that needs to be fixed, Dr. Nelson added. “In the meantime, we’re trying to get the word out that it’s okay to interact with people about the diagnosis, discuss treatment plans, and manage it as one would with any other psychiatric or medical illness.”
 

An evolution, not a debate

Paul Appelbaum, MD, past president of the American Psychiatric Association and current chair of the organization’s DSM steering committee, said in an interview that he hasn’t been involved in any recent debate on this issue.

“I think practice has changed to the point where the general practice is to discuss patient diagnoses with [patients] openly. Patients appreciate that and psychiatrists have come to see the advantages of it,” said Dr. Appelbaum, a professor of psychiatry, medicine, and law at Columbia University, New York.

Dr. Appelbaum noted that patients also increasingly have access to their medical records, “so the reality is that it’s no longer possible in many cases to withhold a diagnosis.”

“I don’t think it’s a debate; I think it’s been an evolution,” he said. “Maybe not everyone is entirely on board yet but there has been a sea change in psychiatric practices.”

Asked whether there needs to be some type of guideline update or statement released by the APA regarding BPD, Dr. Appelbaum said he doesn’t think the overall issue is BPD specific but applies to all psychiatric diagnoses.

“To the extent that there are still practitioners today that are telling students or residents [not to disclose], I would guess that they were trained a very long time ago and have not adapted to the new world,” he said.

“I don’t want to speak for the APA, but speaking for myself: I certainly encourage residents that I teach to be open about a diagnosis. It’s not just clinically helpful in some cases, it’s also ethically required from the perspective of allowing patients to make appropriate decisions about their treatment. And arguably it’s legally required as well, as part of the informed consent requirement,” Dr. Appelbaum said.

Regarding DSM updates, he noted that the committee “looks to the field to propose to us additions or changes to the DSM that are warranted by data that have been gathered since the DSM-5 came out.” There is a process set up on the DSM’s website to review such proposals.

In addition, Dr. Appelbaum said that there have been discussions about using a new model “that focuses on dimensions rather than on discreet categories” in order to classify personality disorders.

“There’s a group out there that is formulating a proposal that they will submit to us” on this, he added. “That’s the major discussion that is going on right now and it would clearly have implications for borderline as well as all the other personality disorders.”

In a statement, the APA said practice guidelines for BPD are currently under review and that the organization does not have a “position statement” on BPD for clinicians. The last update to its guideline was in the early 2000s.

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

News of actor/comedian Pete Davidson expressing relief after finally receiving a diagnosis of borderline personality disorder (BPD) prompted a recent Twitter discussion among physicians regarding the ongoing debate on whether or not to tell a patient he or she has this diagnosis.

“I’ve heard from [many] trainees that they were told never to tell a patient they had BPD, but I can hardly think of anything more paternalistic and stigmatizing,” Amy Barnhorst, MD, vice chair of community psychiatry at University of California, Davis, tweeted.

“Most patients, when I explain it to them, have this kind of reaction – they feel relieved and understood,” she added.

“I was told that as well [not to tell] in one of my practicum placements,” one respondent who identified herself as a clinical/forensic psychologist tweeted back. “I said it anyway and the person was relieved there was a name for what they were living with.”

However, others disagreed with Dr. Barnhorst, noting that BPD is a very serious, stigmatizing, and challenging disorder to treat and, because of this, may cause patients to lose hope.

Still, Dr. Barnhorst stands by her position. Although “there is a negative stigma against a diagnosis of BPD,” that idea more often comes from the clinician instead of the patient, she said.

“I’ve never had a patient say, ‘how dare you call me that!’ like it was an insult,” she said in an interview. Not disclosing a diagnosis “is like you’re not trusting a patient to be a reasonable adult human about this.”
 

‘Hard diagnosis’

Although BPD is a “hard diagnosis, we would never withhold a diagnosis of cancer or liver disease or something else we knew patients didn’t want but that we were going to try and treat them for,” said Dr. Barnhorst.

BPD is linked to significant morbidity because of its common association with comorbid conditions, such as major depressive disorder, substance use disorders, and dysthymia. A history of self-harm is present in 70%-75% of these patients and some estimates suggest up to 9% of individuals with BPD die by suicide.

In an article published in Innovations in Clinical Neuroscience investigators discussed “ethical and clinical questions psychiatrists should consider” when treating BPD, including whether a diagnosis should be shared with a patient.

After such a diagnosis a patient may “react intensely in negative ways and these responses may be easily triggered,” the researchers wrote.

“A propensity that will likely cause psychiatrists anguish, however, is BPD patients’ increased likelihood of attempting suicide,” they added. Part of the problem has been that, in the past, it was thought that a BPD prognosis was untreatable. However, the researchers note that is no longer the case.

Still, Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis, has labeled BPD a so-called “asterisk” disorder.  

As she wrote in a recent blog, “We tell patients when they meet criteria for a medical diagnosis.* We show compassion and nonjudgmentalism to patients.* We do not discriminate against patients.*” However, the asterisk for each of these statements is: *Except for those with BPD.
 

Ongoing debate

Starting around the 1980s, the DSM listed personality disorders under the No. 2 Axis, which is for conditions with symptoms that are “not mitigatable,” said Dr. Nelson.

“It really started as well-meaning therapists who care about their patients who wanted to develop some precision in understanding people, and them starting to notice some patterns that can get in the way of optimal function,” she said in an interview.

The thought was not to disclose these diagnoses “because that was for you to understand, and for the patient to discover these patterns over time in the course of your work together,” Dr. Nelson added.

Although treatment for BPD used to be virtually nonexistent, there is now hope – especially with dialectic-behavior therapy (DBT), which uses mindfulness to teach patients how to control emotions and improve relationships.

According to the National Education Alliance for BPD, other useful treatments include mentalization-based therapy, transference-focused therapy, and “good psychiatric management.” Although there are currently no approved medications for BPD, some drugs are used to treat comorbid conditions such as depression or anxiety.

“We now know that people recover, and the whole paradigm has been turned on its head,” Dr. Nelson said. For example, “we no longer categorize these things as treatable or untreatable, which was a very positive move.”

So why is the field still debating the issue of diagnosis disclosure?

“To this day there are different psychiatrists and some medical school curricula that continue to teach that personality disorders are long-term, fixed, and nontreatable – and that it’s kind of disparaging to give this kind of diagnosis to a patient,” Dr. Nelson said.

Dr. Nelson, also the vice chair for education at the University of Minnesota, Minneapolis, medical school, reported that there “we acknowledge BPD’s painful history and that there are these misconceptions. They’re going to be on the front line of combating discrimination and the idea that if you see a patient with possible BPD coming you should run. That’s just unacceptable.”

Dr. Nelson noted that the idea of disclosing a BPD diagnosis is less controversial now than in the past, but “the whole thing is still under debate, and treatment guidelines [on BPD] are old and expired.”

Criteria for BPD were not updated when the DSM-5 was published in 2013, and that needs to be fixed, Dr. Nelson added. “In the meantime, we’re trying to get the word out that it’s okay to interact with people about the diagnosis, discuss treatment plans, and manage it as one would with any other psychiatric or medical illness.”
 

An evolution, not a debate

Paul Appelbaum, MD, past president of the American Psychiatric Association and current chair of the organization’s DSM steering committee, said in an interview that he hasn’t been involved in any recent debate on this issue.

“I think practice has changed to the point where the general practice is to discuss patient diagnoses with [patients] openly. Patients appreciate that and psychiatrists have come to see the advantages of it,” said Dr. Appelbaum, a professor of psychiatry, medicine, and law at Columbia University, New York.

Dr. Appelbaum noted that patients also increasingly have access to their medical records, “so the reality is that it’s no longer possible in many cases to withhold a diagnosis.”

“I don’t think it’s a debate; I think it’s been an evolution,” he said. “Maybe not everyone is entirely on board yet but there has been a sea change in psychiatric practices.”

Asked whether there needs to be some type of guideline update or statement released by the APA regarding BPD, Dr. Appelbaum said he doesn’t think the overall issue is BPD specific but applies to all psychiatric diagnoses.

“To the extent that there are still practitioners today that are telling students or residents [not to disclose], I would guess that they were trained a very long time ago and have not adapted to the new world,” he said.

“I don’t want to speak for the APA, but speaking for myself: I certainly encourage residents that I teach to be open about a diagnosis. It’s not just clinically helpful in some cases, it’s also ethically required from the perspective of allowing patients to make appropriate decisions about their treatment. And arguably it’s legally required as well, as part of the informed consent requirement,” Dr. Appelbaum said.

Regarding DSM updates, he noted that the committee “looks to the field to propose to us additions or changes to the DSM that are warranted by data that have been gathered since the DSM-5 came out.” There is a process set up on the DSM’s website to review such proposals.

In addition, Dr. Appelbaum said that there have been discussions about using a new model “that focuses on dimensions rather than on discreet categories” in order to classify personality disorders.

“There’s a group out there that is formulating a proposal that they will submit to us” on this, he added. “That’s the major discussion that is going on right now and it would clearly have implications for borderline as well as all the other personality disorders.”

In a statement, the APA said practice guidelines for BPD are currently under review and that the organization does not have a “position statement” on BPD for clinicians. The last update to its guideline was in the early 2000s.

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

News of actor/comedian Pete Davidson expressing relief after finally receiving a diagnosis of borderline personality disorder (BPD) prompted a recent Twitter discussion among physicians regarding the ongoing debate on whether or not to tell a patient he or she has this diagnosis.

“I’ve heard from [many] trainees that they were told never to tell a patient they had BPD, but I can hardly think of anything more paternalistic and stigmatizing,” Amy Barnhorst, MD, vice chair of community psychiatry at University of California, Davis, tweeted.

“Most patients, when I explain it to them, have this kind of reaction – they feel relieved and understood,” she added.

“I was told that as well [not to tell] in one of my practicum placements,” one respondent who identified herself as a clinical/forensic psychologist tweeted back. “I said it anyway and the person was relieved there was a name for what they were living with.”

However, others disagreed with Dr. Barnhorst, noting that BPD is a very serious, stigmatizing, and challenging disorder to treat and, because of this, may cause patients to lose hope.

Still, Dr. Barnhorst stands by her position. Although “there is a negative stigma against a diagnosis of BPD,” that idea more often comes from the clinician instead of the patient, she said.

“I’ve never had a patient say, ‘how dare you call me that!’ like it was an insult,” she said in an interview. Not disclosing a diagnosis “is like you’re not trusting a patient to be a reasonable adult human about this.”
 

‘Hard diagnosis’

Although BPD is a “hard diagnosis, we would never withhold a diagnosis of cancer or liver disease or something else we knew patients didn’t want but that we were going to try and treat them for,” said Dr. Barnhorst.

BPD is linked to significant morbidity because of its common association with comorbid conditions, such as major depressive disorder, substance use disorders, and dysthymia. A history of self-harm is present in 70%-75% of these patients and some estimates suggest up to 9% of individuals with BPD die by suicide.

In an article published in Innovations in Clinical Neuroscience investigators discussed “ethical and clinical questions psychiatrists should consider” when treating BPD, including whether a diagnosis should be shared with a patient.

After such a diagnosis a patient may “react intensely in negative ways and these responses may be easily triggered,” the researchers wrote.

“A propensity that will likely cause psychiatrists anguish, however, is BPD patients’ increased likelihood of attempting suicide,” they added. Part of the problem has been that, in the past, it was thought that a BPD prognosis was untreatable. However, the researchers note that is no longer the case.

Still, Kaz Nelson, MD, associate professor of psychiatry and behavioral sciences at the University of Minnesota, Minneapolis, has labeled BPD a so-called “asterisk” disorder.  

As she wrote in a recent blog, “We tell patients when they meet criteria for a medical diagnosis.* We show compassion and nonjudgmentalism to patients.* We do not discriminate against patients.*” However, the asterisk for each of these statements is: *Except for those with BPD.
 

Ongoing debate

Starting around the 1980s, the DSM listed personality disorders under the No. 2 Axis, which is for conditions with symptoms that are “not mitigatable,” said Dr. Nelson.

“It really started as well-meaning therapists who care about their patients who wanted to develop some precision in understanding people, and them starting to notice some patterns that can get in the way of optimal function,” she said in an interview.

The thought was not to disclose these diagnoses “because that was for you to understand, and for the patient to discover these patterns over time in the course of your work together,” Dr. Nelson added.

Although treatment for BPD used to be virtually nonexistent, there is now hope – especially with dialectic-behavior therapy (DBT), which uses mindfulness to teach patients how to control emotions and improve relationships.

According to the National Education Alliance for BPD, other useful treatments include mentalization-based therapy, transference-focused therapy, and “good psychiatric management.” Although there are currently no approved medications for BPD, some drugs are used to treat comorbid conditions such as depression or anxiety.

“We now know that people recover, and the whole paradigm has been turned on its head,” Dr. Nelson said. For example, “we no longer categorize these things as treatable or untreatable, which was a very positive move.”

So why is the field still debating the issue of diagnosis disclosure?

“To this day there are different psychiatrists and some medical school curricula that continue to teach that personality disorders are long-term, fixed, and nontreatable – and that it’s kind of disparaging to give this kind of diagnosis to a patient,” Dr. Nelson said.

Dr. Nelson, also the vice chair for education at the University of Minnesota, Minneapolis, medical school, reported that there “we acknowledge BPD’s painful history and that there are these misconceptions. They’re going to be on the front line of combating discrimination and the idea that if you see a patient with possible BPD coming you should run. That’s just unacceptable.”

Dr. Nelson noted that the idea of disclosing a BPD diagnosis is less controversial now than in the past, but “the whole thing is still under debate, and treatment guidelines [on BPD] are old and expired.”

Criteria for BPD were not updated when the DSM-5 was published in 2013, and that needs to be fixed, Dr. Nelson added. “In the meantime, we’re trying to get the word out that it’s okay to interact with people about the diagnosis, discuss treatment plans, and manage it as one would with any other psychiatric or medical illness.”
 

An evolution, not a debate

Paul Appelbaum, MD, past president of the American Psychiatric Association and current chair of the organization’s DSM steering committee, said in an interview that he hasn’t been involved in any recent debate on this issue.

“I think practice has changed to the point where the general practice is to discuss patient diagnoses with [patients] openly. Patients appreciate that and psychiatrists have come to see the advantages of it,” said Dr. Appelbaum, a professor of psychiatry, medicine, and law at Columbia University, New York.

Dr. Appelbaum noted that patients also increasingly have access to their medical records, “so the reality is that it’s no longer possible in many cases to withhold a diagnosis.”

“I don’t think it’s a debate; I think it’s been an evolution,” he said. “Maybe not everyone is entirely on board yet but there has been a sea change in psychiatric practices.”

Asked whether there needs to be some type of guideline update or statement released by the APA regarding BPD, Dr. Appelbaum said he doesn’t think the overall issue is BPD specific but applies to all psychiatric diagnoses.

“To the extent that there are still practitioners today that are telling students or residents [not to disclose], I would guess that they were trained a very long time ago and have not adapted to the new world,” he said.

“I don’t want to speak for the APA, but speaking for myself: I certainly encourage residents that I teach to be open about a diagnosis. It’s not just clinically helpful in some cases, it’s also ethically required from the perspective of allowing patients to make appropriate decisions about their treatment. And arguably it’s legally required as well, as part of the informed consent requirement,” Dr. Appelbaum said.

Regarding DSM updates, he noted that the committee “looks to the field to propose to us additions or changes to the DSM that are warranted by data that have been gathered since the DSM-5 came out.” There is a process set up on the DSM’s website to review such proposals.

In addition, Dr. Appelbaum said that there have been discussions about using a new model “that focuses on dimensions rather than on discreet categories” in order to classify personality disorders.

“There’s a group out there that is formulating a proposal that they will submit to us” on this, he added. “That’s the major discussion that is going on right now and it would clearly have implications for borderline as well as all the other personality disorders.”

In a statement, the APA said practice guidelines for BPD are currently under review and that the organization does not have a “position statement” on BPD for clinicians. The last update to its guideline was in the early 2000s.

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

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

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

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

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

April 5 is the official start date of a U.S. law requiring health care organizations to provide patients with free, full, and immediate electronic access to their doctor’s clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, a wide-ranging piece of federal health care legislation. The previous deadline of Nov. 2, 2020, for enacting open notes was extended last year because of the exigencies of the COVID-19 pandemic.

Organizations must provide access via patient portals to the following types of notes: consultations, discharge summaries, histories, physical examination findings, imaging narratives, laboratory and pathology report narratives, and procedure and progress notes. Noncompliant organizations will eventually be subject to fines from the Department of Health & Human Services for “information blocking.”

This news organization reported on the mandate in 2020, and some readers said it was an unwelcome intrusion into practice. Since then, this news organization has run additional open notes stories about physician concerns, a perspective essay addressing those fears, and a reader poll about the phenomenon.

Now, as the legislation turns into a practical clinical matter, there are five key points clinicians should consider.
 

Clinicians don’t have to change writing style.

The new law mandates timely patient access to notes and test results, but it doesn’t require that clinicians alter their writing, said Scott MacDonald, MD, an internist and electronic health record medical director at University of California Davis Health in Sacramento.

“You don’t have to change your notes,” he said. However, patients are now part of the note audience and some health care systems are directing clinicians to make patient-friendly style changes.

Everyday experience should guide clinicians when writing notes, said one expert.

“When you’re not sure [of how to write a note], just mirror the way you would speak in the office – that’s going to get you right, including for mental health issues,” advised Leonor Fernandez, MD, an internist at Beth Deaconess Israel Medical Center, Boston, in her “take-away” comments in the online video, How to Write an Open Note.

According to a 2020 Medscape poll of 1,050 physicians, a majority (56%) anticipate that they will write notes differently, knowing that patients can read them via open notes. Nearly two-thirds (64%) believe that this new wrinkle in medical records will increase their workload. However, actual practice suggests that this is true for a minority of practitioners, according to the results from a recent study of more than 1,000 physicians in Boston, Seattle, and rural Pennsylvania, who already work in open notes settings. Only about one-third (37%) reported “spending more time on documentation.”

Note writing is going to change because of the addition of the patient reader, and something will be lost, argued Steven Reidbord, MD, a psychiatrist in private practice in San Francisco. By watering down the language for patients, “you are trading away the technical precision and other advantages of having a professional language,” commented Dr. Reidbord, who blogs for Psychology Today and has criticized the open notes movement in the past.

However, years of investigation from OpenNotes, the Boston-based advocacy and research organization, indicates that there are many gains with patient-accessible notes, including improved medical record accuracy, greater medication adherence, and potentially improved health care disparities among a range of patient types. In a 2019 study, researchers said that worry and confusion among note-reading patients are uncommon (5% and 3%, respectively), which addresses two criticisms voiced by multiple people last year.
 

Some clinical notes can be withheld. 

The new rules from the federal government permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties, Tom Delbanco, MD, and Charlotte Blease, PhD, of OpenNotes in Boston wrote in a commentary in February 2021.

There are also state-level laws that can supersede the new U.S. law and block access to notes, points out MacDonald. For example, California law dictates that providers cannot post cancer test results without talking with the patient first.

The OpenNotes organization also points out that, with regard to sensitive psychotherapy notes that are separated from the rest of a medical record, those notes “can be kept from patients without their permission, and such rules vary state by state.”
 

Some patients are more likely readers. 

Some patients are more likely to peer into their files than others, said Liz Salmi, senior strategist at OpenNotes, who is also a brain cancer patient.

“Those patients who have more serious or chronic conditions ... are more likely to read their notes,” she said in an interview.

A new study of nearly 6,000 medical oncology patients at the University of Wisconsin confirmed that opinion. Patients with incurable metastatic disease were much more likely than those with early-stage, curable disease to read notes. Notably, younger patients were more likely than older ones to access notes, likely the result of generational tech savvy.

Despite the unpredictability of serious disease such as cancer, oncology patients find satisfaction in reading their notes, say experts. “We’ve overwhelmingly heard that patients like it,” Thomas LeBlanc, MD, medical oncologist at Duke University, Durham, N.C., where all patients already have access to clinicians’ notes, told this news organization in 2018.
 

You are part of the avant garde. 

The United States and Scandinavian countries are the world leaders in implementing open notes in clinical practice, Dr. Blease said in an interview.

“It’s a phenomenal achievement” to have enacted open notes nationally, she said. For example, there are no open notes in Northern Ireland, Dr. Blease’s home country, or most of Europe.

In the United States, there are more than 200 medical organizations, including at least one in every state, that were voluntarily providing open notes before April 5, including interstate giants such as Banner Health and big-name medical centers such as Cleveland Clinic.

It may be hard for the United States to top Sweden’s embrace of the practice. The national open notes program now has 7.2 million patient accounts in a country of 10 million people, noted Maria Häggland, PhD, of Uppsala (Sweden) MedTech Science Innovation Center during a webinar last year.
 

The start day will come, and you may not notice. 

“When April 5 happens, something brand new is going to happen symbolically,” Ms. Salmi said. Its importance is hard to measure.

“Patients say they trust their doctor more because they understand their thinking with open notes. How do you value that? We don’t have metrics for that,” she said.

Dr. MacDonald suggested that open notes are both new and not new. In the fall of 2020, he predicted that the launch day would come, and few clinicians would notice, in part because many patients already access truncated information via patient portals.

However, there are “sensitive issues,” such as with adolescents and reproductive health, where “we know that some parents have sign-in information for their teen’s portal,” he commented. With clinical notes now on full display, potential problems “may be out of our control.”

Still, the Sacramento-based physician and IT officer acknowledged that concerns about open notes may be a bit inflated. “I’ve been more worried about reassuring physicians that everything will be okay than what’s actually going to happen [as the law takes effect],” Dr. MacDonald said.

The OpenNotes organization is grant funded, and staff disclosed no relevant financial relationships.

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

Significant survival gains were seen when the immune checkpoint inhibitor camrelizumab was added to standard chemotherapy for the first-line treatment of advanced squamous non–small cell lung cancer (NSCLC) in a phase 3 trial conducted in China.

Results of the CAMEL-sq trial showed a progression-free survival (PFS) advantage of 3.6 months with camrelizumab plus chemotherapy, compared with chemotherapy plus placebo (P < .0001). The median overall survival (OS) was not reached in the camrelizumab arm, but it was significantly better than in the placebo arm (P < .0001).

Camrelizumab plus chemotherapy is already a standard of care in China for patients with advanced nonsquamous NSCLC who are negative for EGFR and ALK mutations, study investigator Caicun Zhou, MD, PhD, said when presenting the CAMEL-sq results at the European Lung Cancer Virtual Congress 2021 (Abstract 96O).

The CAMEL-sq findings now support the combination as a “standard first-line treatment for advanced squamous NSCLC,” said Dr. Zhou of Shanghai Pulmonary Hospital and Tongji University.

“The study has kind of changed our daily practice,” he said. “I do think we will have the label, camrelizumab plus chemo as first-line treatment for squamous [NSCLC] in China, maybe in a couple of months.”

“Camrelizumab will most likely be another brick in the wall for our Chinese patients and colleagues to use for patients with squamous histology, non–small cell lung cancer in addition to pembrolizumab,” said Julie Renee Brahmer, MD, of Johns Hopkins Medicine in Baltimore, who was the invited discussant for the trial.

Dr. Brahmer noted that the PFS hazard ratio in this trial – 0.37 – was “impressive.”
 

Patients and treatment

CAMEL-sq is a phase 3, double-blind, multicenter trial. The 390 patients enrolled had pathologically-confirmed stage IIIB or IV squamous NSCLC, and they had not received any prior treatment.

Patients received four to six cycles of chemotherapy, consisting of carboplatin and paclitaxel given every 3 weeks. Camrelizumab was added to one arm at a dose of 200 mg, and placebo was added to the other.

This was followed by a maintenance phase in which patients remained on active treatment with camrelizumab or placebo for up to 2 years. Patients in the placebo arm could cross over to camrelizumab at progression.

The median age of patients was similar in the camrelizumab and placebo arms (64 years and 62 years, respectively). The majority of study subjects in both arms were men (more than 90%), had a history of smoking (more than 80%), and had stage IV disease (more than 70%).
 

Efficacy and safety

The median PFS was 8.5 months in the camrelizumab arm and 4.9 months in the placebo arm (HR, 0.37; P < .0001). The median OS was not reached in the camrelizumab arm and was 14.5 months in the placebo arm (HR, 0.55, P < .0001).

The survival benefits were observed in spite of a crossover rate of 46.9%, Dr. Zhou noted.

Furthermore, survival benefits were consistent across all the subgroups tested. Regardless of age, sex, performance status, smoking history, disease stage, presence of liver or brain metastases, or PD-L1 expression, there was an apparent advantage of camrelizumab over placebo.

The objective response rate was higher in the camrelizumab arm than in the placebo arm, at 64.8% and 36.7%, respectively (P < .0001).

The clinical response seen with camrelizumab was “robust and durable,” Dr. Zhou said. Indeed, the duration of response was 13.1 months in the camrelizumab arm and 4.4 months in the placebo arm.

Grade 3/4 treatment-related adverse events (AEs) were reported in a similar percentage of camrelizumab- or placebo-treated patients (73.6% and 71.4%, respectively). However, “the majority of treatment-related adverse effects were chemotherapy related,” Dr. Zhou pointed out. This included decreased total white blood cell, neutrophil, red blood cell, and platelet counts as well as alopecia and increased liver enzymes.

Immune-related AEs occurred in 76.7% of patients in the camrelizumab arm and 20.4% of those in the placebo arm.

“The majority of immune-related adverse events were grade 1 or grade 2; easily manageable in our daily practice,” Dr. Zhou noted.
 

Putting CAMEL-sq into perspective

Data from other trials of immunotherapy-chemotherapy combinations in squamous NSCLC have been presented recently but with less impressive results, Dr. Brahmer said.

In one trial – ORIENT-12 – sintilimab was combined with gemcitabine and cisplatin (ESMO 2020, Abstract LBA56). The median PFS, per investigators, was 5.5 months with sintilimab and 4.9 months without it, both of which are lower than the 8.5 months seen with camrelizumab plus chemotherapy in the CAMEL-sq trial.

Another trial is KEYNOTE-407, in which patients received pembrolizumab or placebo plus a carboplatin-paclitaxel (or nab-paclitaxel) regimen. Three-year follow-up data from the trial were presented at ELCC 2021 (Abstract 97O). Continued improvements in second PFS (HR, 0.59) and OS (HR, 0.71) were observed with pembrolizumab-chemotherapy versus placebo-chemotherapy.

“We have to remember the high PD-L1-negative disease rate in the CAMEL-sq study, compared to the KEYNOTE-407 rate,” before stacking the two studies against each other, Dr. Brahmer noted. In KEYNOTE-407, almost 35% of patients had PD-L1 expression of less than 1%, compared with nearly 50% in the CAMEL-sq study.

That aside, “very similar impressive 1-year progression-free survival rates are seen on both studies,” Dr. Brahmer said. “I hope that camrelizumab has continued follow-up so we can see how these patients will do long-term.

“My eyebrows were raised a little bit at the camrelizumab immune-related AE rate of almost 76%, compared to the immune-related AE rate of about 36% in the KEYNOTE-407 study,” Dr. Brahmer said.

She noted, however, that almost two-thirds of the immune-related AEs in CAMEL-sq were due to reactive cutaneous capillary endothelial proliferation, which doesn’t appear to have been previously reported with PD-1 or PD-L1 inhibitors. This is a side effect seen in studies of liver cancer and may be linked to PFS, Dr. Brahmer said.

CAMEL-sq is funded by Jiangsu Hengrui Medicine Co. Ltd. Dr. Zhou disclosed honoraria from multiple pharmaceutical companies, including the study sponsor. Two of Dr. Zhou’s coauthors are employees of the company. Dr. Brahmer disclosed relationships with Amgen, Bristol Myers Squibb, Eli Lily, GlaxoSmithKline, Merck, Sanofi, Easi, AstraZeneca, Genentech, Regeneron, and RAPT Therapeutics Inc.

Significant survival gains were seen when the immune checkpoint inhibitor camrelizumab was added to standard chemotherapy for the first-line treatment of advanced squamous non–small cell lung cancer (NSCLC) in a phase 3 trial conducted in China.

Results of the CAMEL-sq trial showed a progression-free survival (PFS) advantage of 3.6 months with camrelizumab plus chemotherapy, compared with chemotherapy plus placebo (P < .0001). The median overall survival (OS) was not reached in the camrelizumab arm, but it was significantly better than in the placebo arm (P < .0001).

Camrelizumab plus chemotherapy is already a standard of care in China for patients with advanced nonsquamous NSCLC who are negative for EGFR and ALK mutations, study investigator Caicun Zhou, MD, PhD, said when presenting the CAMEL-sq results at the European Lung Cancer Virtual Congress 2021 (Abstract 96O).

The CAMEL-sq findings now support the combination as a “standard first-line treatment for advanced squamous NSCLC,” said Dr. Zhou of Shanghai Pulmonary Hospital and Tongji University.

“The study has kind of changed our daily practice,” he said. “I do think we will have the label, camrelizumab plus chemo as first-line treatment for squamous [NSCLC] in China, maybe in a couple of months.”

“Camrelizumab will most likely be another brick in the wall for our Chinese patients and colleagues to use for patients with squamous histology, non–small cell lung cancer in addition to pembrolizumab,” said Julie Renee Brahmer, MD, of Johns Hopkins Medicine in Baltimore, who was the invited discussant for the trial.

Dr. Brahmer noted that the PFS hazard ratio in this trial – 0.37 – was “impressive.”
 

Patients and treatment

CAMEL-sq is a phase 3, double-blind, multicenter trial. The 390 patients enrolled had pathologically-confirmed stage IIIB or IV squamous NSCLC, and they had not received any prior treatment.

Patients received four to six cycles of chemotherapy, consisting of carboplatin and paclitaxel given every 3 weeks. Camrelizumab was added to one arm at a dose of 200 mg, and placebo was added to the other.

This was followed by a maintenance phase in which patients remained on active treatment with camrelizumab or placebo for up to 2 years. Patients in the placebo arm could cross over to camrelizumab at progression.

The median age of patients was similar in the camrelizumab and placebo arms (64 years and 62 years, respectively). The majority of study subjects in both arms were men (more than 90%), had a history of smoking (more than 80%), and had stage IV disease (more than 70%).
 

Efficacy and safety

The median PFS was 8.5 months in the camrelizumab arm and 4.9 months in the placebo arm (HR, 0.37; P < .0001). The median OS was not reached in the camrelizumab arm and was 14.5 months in the placebo arm (HR, 0.55, P < .0001).

The survival benefits were observed in spite of a crossover rate of 46.9%, Dr. Zhou noted.

Furthermore, survival benefits were consistent across all the subgroups tested. Regardless of age, sex, performance status, smoking history, disease stage, presence of liver or brain metastases, or PD-L1 expression, there was an apparent advantage of camrelizumab over placebo.

The objective response rate was higher in the camrelizumab arm than in the placebo arm, at 64.8% and 36.7%, respectively (P < .0001).

The clinical response seen with camrelizumab was “robust and durable,” Dr. Zhou said. Indeed, the duration of response was 13.1 months in the camrelizumab arm and 4.4 months in the placebo arm.

Grade 3/4 treatment-related adverse events (AEs) were reported in a similar percentage of camrelizumab- or placebo-treated patients (73.6% and 71.4%, respectively). However, “the majority of treatment-related adverse effects were chemotherapy related,” Dr. Zhou pointed out. This included decreased total white blood cell, neutrophil, red blood cell, and platelet counts as well as alopecia and increased liver enzymes.

Immune-related AEs occurred in 76.7% of patients in the camrelizumab arm and 20.4% of those in the placebo arm.

“The majority of immune-related adverse events were grade 1 or grade 2; easily manageable in our daily practice,” Dr. Zhou noted.
 

Putting CAMEL-sq into perspective

Data from other trials of immunotherapy-chemotherapy combinations in squamous NSCLC have been presented recently but with less impressive results, Dr. Brahmer said.

In one trial – ORIENT-12 – sintilimab was combined with gemcitabine and cisplatin (ESMO 2020, Abstract LBA56). The median PFS, per investigators, was 5.5 months with sintilimab and 4.9 months without it, both of which are lower than the 8.5 months seen with camrelizumab plus chemotherapy in the CAMEL-sq trial.

Another trial is KEYNOTE-407, in which patients received pembrolizumab or placebo plus a carboplatin-paclitaxel (or nab-paclitaxel) regimen. Three-year follow-up data from the trial were presented at ELCC 2021 (Abstract 97O). Continued improvements in second PFS (HR, 0.59) and OS (HR, 0.71) were observed with pembrolizumab-chemotherapy versus placebo-chemotherapy.

“We have to remember the high PD-L1-negative disease rate in the CAMEL-sq study, compared to the KEYNOTE-407 rate,” before stacking the two studies against each other, Dr. Brahmer noted. In KEYNOTE-407, almost 35% of patients had PD-L1 expression of less than 1%, compared with nearly 50% in the CAMEL-sq study.

That aside, “very similar impressive 1-year progression-free survival rates are seen on both studies,” Dr. Brahmer said. “I hope that camrelizumab has continued follow-up so we can see how these patients will do long-term.

“My eyebrows were raised a little bit at the camrelizumab immune-related AE rate of almost 76%, compared to the immune-related AE rate of about 36% in the KEYNOTE-407 study,” Dr. Brahmer said.

She noted, however, that almost two-thirds of the immune-related AEs in CAMEL-sq were due to reactive cutaneous capillary endothelial proliferation, which doesn’t appear to have been previously reported with PD-1 or PD-L1 inhibitors. This is a side effect seen in studies of liver cancer and may be linked to PFS, Dr. Brahmer said.

CAMEL-sq is funded by Jiangsu Hengrui Medicine Co. Ltd. Dr. Zhou disclosed honoraria from multiple pharmaceutical companies, including the study sponsor. Two of Dr. Zhou’s coauthors are employees of the company. Dr. Brahmer disclosed relationships with Amgen, Bristol Myers Squibb, Eli Lily, GlaxoSmithKline, Merck, Sanofi, Easi, AstraZeneca, Genentech, Regeneron, and RAPT Therapeutics Inc.

Significant survival gains were seen when the immune checkpoint inhibitor camrelizumab was added to standard chemotherapy for the first-line treatment of advanced squamous non–small cell lung cancer (NSCLC) in a phase 3 trial conducted in China.

Results of the CAMEL-sq trial showed a progression-free survival (PFS) advantage of 3.6 months with camrelizumab plus chemotherapy, compared with chemotherapy plus placebo (P < .0001). The median overall survival (OS) was not reached in the camrelizumab arm, but it was significantly better than in the placebo arm (P < .0001).

Camrelizumab plus chemotherapy is already a standard of care in China for patients with advanced nonsquamous NSCLC who are negative for EGFR and ALK mutations, study investigator Caicun Zhou, MD, PhD, said when presenting the CAMEL-sq results at the European Lung Cancer Virtual Congress 2021 (Abstract 96O).

The CAMEL-sq findings now support the combination as a “standard first-line treatment for advanced squamous NSCLC,” said Dr. Zhou of Shanghai Pulmonary Hospital and Tongji University.

“The study has kind of changed our daily practice,” he said. “I do think we will have the label, camrelizumab plus chemo as first-line treatment for squamous [NSCLC] in China, maybe in a couple of months.”

“Camrelizumab will most likely be another brick in the wall for our Chinese patients and colleagues to use for patients with squamous histology, non–small cell lung cancer in addition to pembrolizumab,” said Julie Renee Brahmer, MD, of Johns Hopkins Medicine in Baltimore, who was the invited discussant for the trial.

Dr. Brahmer noted that the PFS hazard ratio in this trial – 0.37 – was “impressive.”
 

Patients and treatment

CAMEL-sq is a phase 3, double-blind, multicenter trial. The 390 patients enrolled had pathologically-confirmed stage IIIB or IV squamous NSCLC, and they had not received any prior treatment.

Patients received four to six cycles of chemotherapy, consisting of carboplatin and paclitaxel given every 3 weeks. Camrelizumab was added to one arm at a dose of 200 mg, and placebo was added to the other.

This was followed by a maintenance phase in which patients remained on active treatment with camrelizumab or placebo for up to 2 years. Patients in the placebo arm could cross over to camrelizumab at progression.

The median age of patients was similar in the camrelizumab and placebo arms (64 years and 62 years, respectively). The majority of study subjects in both arms were men (more than 90%), had a history of smoking (more than 80%), and had stage IV disease (more than 70%).
 

Efficacy and safety

The median PFS was 8.5 months in the camrelizumab arm and 4.9 months in the placebo arm (HR, 0.37; P < .0001). The median OS was not reached in the camrelizumab arm and was 14.5 months in the placebo arm (HR, 0.55, P < .0001).

The survival benefits were observed in spite of a crossover rate of 46.9%, Dr. Zhou noted.

Furthermore, survival benefits were consistent across all the subgroups tested. Regardless of age, sex, performance status, smoking history, disease stage, presence of liver or brain metastases, or PD-L1 expression, there was an apparent advantage of camrelizumab over placebo.

The objective response rate was higher in the camrelizumab arm than in the placebo arm, at 64.8% and 36.7%, respectively (P < .0001).

The clinical response seen with camrelizumab was “robust and durable,” Dr. Zhou said. Indeed, the duration of response was 13.1 months in the camrelizumab arm and 4.4 months in the placebo arm.

Grade 3/4 treatment-related adverse events (AEs) were reported in a similar percentage of camrelizumab- or placebo-treated patients (73.6% and 71.4%, respectively). However, “the majority of treatment-related adverse effects were chemotherapy related,” Dr. Zhou pointed out. This included decreased total white blood cell, neutrophil, red blood cell, and platelet counts as well as alopecia and increased liver enzymes.

Immune-related AEs occurred in 76.7% of patients in the camrelizumab arm and 20.4% of those in the placebo arm.

“The majority of immune-related adverse events were grade 1 or grade 2; easily manageable in our daily practice,” Dr. Zhou noted.
 

Putting CAMEL-sq into perspective

Data from other trials of immunotherapy-chemotherapy combinations in squamous NSCLC have been presented recently but with less impressive results, Dr. Brahmer said.

In one trial – ORIENT-12 – sintilimab was combined with gemcitabine and cisplatin (ESMO 2020, Abstract LBA56). The median PFS, per investigators, was 5.5 months with sintilimab and 4.9 months without it, both of which are lower than the 8.5 months seen with camrelizumab plus chemotherapy in the CAMEL-sq trial.

Another trial is KEYNOTE-407, in which patients received pembrolizumab or placebo plus a carboplatin-paclitaxel (or nab-paclitaxel) regimen. Three-year follow-up data from the trial were presented at ELCC 2021 (Abstract 97O). Continued improvements in second PFS (HR, 0.59) and OS (HR, 0.71) were observed with pembrolizumab-chemotherapy versus placebo-chemotherapy.

“We have to remember the high PD-L1-negative disease rate in the CAMEL-sq study, compared to the KEYNOTE-407 rate,” before stacking the two studies against each other, Dr. Brahmer noted. In KEYNOTE-407, almost 35% of patients had PD-L1 expression of less than 1%, compared with nearly 50% in the CAMEL-sq study.

That aside, “very similar impressive 1-year progression-free survival rates are seen on both studies,” Dr. Brahmer said. “I hope that camrelizumab has continued follow-up so we can see how these patients will do long-term.

“My eyebrows were raised a little bit at the camrelizumab immune-related AE rate of almost 76%, compared to the immune-related AE rate of about 36% in the KEYNOTE-407 study,” Dr. Brahmer said.

She noted, however, that almost two-thirds of the immune-related AEs in CAMEL-sq were due to reactive cutaneous capillary endothelial proliferation, which doesn’t appear to have been previously reported with PD-1 or PD-L1 inhibitors. This is a side effect seen in studies of liver cancer and may be linked to PFS, Dr. Brahmer said.

CAMEL-sq is funded by Jiangsu Hengrui Medicine Co. Ltd. Dr. Zhou disclosed honoraria from multiple pharmaceutical companies, including the study sponsor. Two of Dr. Zhou’s coauthors are employees of the company. Dr. Brahmer disclosed relationships with Amgen, Bristol Myers Squibb, Eli Lily, GlaxoSmithKline, Merck, Sanofi, Easi, AstraZeneca, Genentech, Regeneron, and RAPT Therapeutics Inc.

Background: Previous studies have shown that aspirin reduces the relative risk of cardiovascular disease (CVD) but also increases the relative risk of bleeding. It is unclear if there are patients without known CVD in whom the absolute risk reduction of CVD outweighs the absolute risk of bleeding. Prognostic CVD and bleeding risk models allow for an assessment of absolute risks and primary preventive interventions.

Study design: Individualized risk-benefit analysis based on sex-specific risk scores and estimates from PREDICT cohort data.

Setting: Primary care practices in New Zealand.

Synopsis: Using the New Zealand–based PREDICT online tool, 245,048 patients had their CVD risk assessed and did not meet exclusion criteria. The online tool predicts CVD events avoided and bleeding events caused by aspirin. When one CVD event was equivalent to one major bleeding event, 2.5% of women and 12.1% of men were classified as benefiting from aspirin (more CVD events avoided than bleeding events caused). When one CVD event was equivalent to two major bleeding events, 21.4% of women and 40.7% of men were classified as benefiting from aspirin. The net-benefit subgroups were older, and had higher baseline 5-year CVD risk, fewer risk factors for bleeding, higher systolic blood pressure, and a higher total cholesterol to HDL cholesterol ratio. Ethnicity and socioeconomic index also influenced benefit or harm.

With use of the upper and lower limits of 95% confidence intervals for models, there were considerable ranges of benefit versus harm. Sex-specific risk scores and meta-analysis have intrinsic uncertainties and results potentially not generalizable outside New Zealand population. Ultimate decision to use aspirin requires shared decision making.

Bottom line: Some patients are likely to derive a net benefit from aspirin for primary prevention of CVD. Risk-benefit models with online tools can help providers and patients estimate these factors to inform shared decision making.

Citation: Selak V et al. Personalized prediction of cardiovascular benefits and bleeding harms for aspirin for primary prevention, a benefit-harm analysis. Ann Intern Med. 2019;71(8):529-39.

Dr. Rupp is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.

Background: Previous studies have shown that aspirin reduces the relative risk of cardiovascular disease (CVD) but also increases the relative risk of bleeding. It is unclear if there are patients without known CVD in whom the absolute risk reduction of CVD outweighs the absolute risk of bleeding. Prognostic CVD and bleeding risk models allow for an assessment of absolute risks and primary preventive interventions.

Study design: Individualized risk-benefit analysis based on sex-specific risk scores and estimates from PREDICT cohort data.

Setting: Primary care practices in New Zealand.

Synopsis: Using the New Zealand–based PREDICT online tool, 245,048 patients had their CVD risk assessed and did not meet exclusion criteria. The online tool predicts CVD events avoided and bleeding events caused by aspirin. When one CVD event was equivalent to one major bleeding event, 2.5% of women and 12.1% of men were classified as benefiting from aspirin (more CVD events avoided than bleeding events caused). When one CVD event was equivalent to two major bleeding events, 21.4% of women and 40.7% of men were classified as benefiting from aspirin. The net-benefit subgroups were older, and had higher baseline 5-year CVD risk, fewer risk factors for bleeding, higher systolic blood pressure, and a higher total cholesterol to HDL cholesterol ratio. Ethnicity and socioeconomic index also influenced benefit or harm.

With use of the upper and lower limits of 95% confidence intervals for models, there were considerable ranges of benefit versus harm. Sex-specific risk scores and meta-analysis have intrinsic uncertainties and results potentially not generalizable outside New Zealand population. Ultimate decision to use aspirin requires shared decision making.

Bottom line: Some patients are likely to derive a net benefit from aspirin for primary prevention of CVD. Risk-benefit models with online tools can help providers and patients estimate these factors to inform shared decision making.

Citation: Selak V et al. Personalized prediction of cardiovascular benefits and bleeding harms for aspirin for primary prevention, a benefit-harm analysis. Ann Intern Med. 2019;71(8):529-39.

Dr. Rupp is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.

Background: Previous studies have shown that aspirin reduces the relative risk of cardiovascular disease (CVD) but also increases the relative risk of bleeding. It is unclear if there are patients without known CVD in whom the absolute risk reduction of CVD outweighs the absolute risk of bleeding. Prognostic CVD and bleeding risk models allow for an assessment of absolute risks and primary preventive interventions.

Study design: Individualized risk-benefit analysis based on sex-specific risk scores and estimates from PREDICT cohort data.

Setting: Primary care practices in New Zealand.

Synopsis: Using the New Zealand–based PREDICT online tool, 245,048 patients had their CVD risk assessed and did not meet exclusion criteria. The online tool predicts CVD events avoided and bleeding events caused by aspirin. When one CVD event was equivalent to one major bleeding event, 2.5% of women and 12.1% of men were classified as benefiting from aspirin (more CVD events avoided than bleeding events caused). When one CVD event was equivalent to two major bleeding events, 21.4% of women and 40.7% of men were classified as benefiting from aspirin. The net-benefit subgroups were older, and had higher baseline 5-year CVD risk, fewer risk factors for bleeding, higher systolic blood pressure, and a higher total cholesterol to HDL cholesterol ratio. Ethnicity and socioeconomic index also influenced benefit or harm.

With use of the upper and lower limits of 95% confidence intervals for models, there were considerable ranges of benefit versus harm. Sex-specific risk scores and meta-analysis have intrinsic uncertainties and results potentially not generalizable outside New Zealand population. Ultimate decision to use aspirin requires shared decision making.

Bottom line: Some patients are likely to derive a net benefit from aspirin for primary prevention of CVD. Risk-benefit models with online tools can help providers and patients estimate these factors to inform shared decision making.

Citation: Selak V et al. Personalized prediction of cardiovascular benefits and bleeding harms for aspirin for primary prevention, a benefit-harm analysis. Ann Intern Med. 2019;71(8):529-39.

Dr. Rupp is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.

COVID-19 was the third-leading cause of death in the United States in 2020, but that mortality burden did not fall evenly along racial/ethnic lines, according to a provisional report from the Centers for Disease Control and Prevention.

Only heart disease and cancer caused more deaths than SARS-CoV-2, which took the lives of almost 378,000 Americans last year, Farida B. Ahmad, MPH, and associates at the National Center for Health Statistics noted March 31 in the Morbidity and Mortality Weekly Report.

That represents 11.2% of the almost 3.36 million total deaths recorded in 2020. The racial/ethnics demographics, however, show that 22.4% of all deaths among Hispanic Americans were COVID-19–related, as were 18.6% of deaths in American Indians/Alaska Natives. Deaths among Asian persons, at 14.7%, and African Americans, at 13.5%, were closer but still above the national figure, while Whites (9.3%) were the only major subgroup below it, based on data from the National Vital Statistics System.

Age-adjusted death rates tell a somewhat different story: American Indian/Alaska native persons were highest with a rate of 187.8 COVID-19–associated deaths per 100,000 standard population, with Hispanic persons second at 164.3 per 100,000. Blacks were next at 151.1 deaths per 100,000, but Whites had a higher rate (72.5) than did Asian Americans (66.7), the CDC investigators reported.

“During January-December 2020, the estimated 2020 age-adjusted death rate increased for the first time since 2017, with an increase of 15.9% compared with 2019, from 715.2 to 828.7 deaths per 100,000 population,” they wrote, noting that “certain categories of race (i.e., AI/AN and Asian) and Hispanic ethnicity reported on death certificates might have been misclassified, possibly resulting in underestimates of death rates for some groups.”

[email protected]

COVID-19 was the third-leading cause of death in the United States in 2020, but that mortality burden did not fall evenly along racial/ethnic lines, according to a provisional report from the Centers for Disease Control and Prevention.

Only heart disease and cancer caused more deaths than SARS-CoV-2, which took the lives of almost 378,000 Americans last year, Farida B. Ahmad, MPH, and associates at the National Center for Health Statistics noted March 31 in the Morbidity and Mortality Weekly Report.

That represents 11.2% of the almost 3.36 million total deaths recorded in 2020. The racial/ethnics demographics, however, show that 22.4% of all deaths among Hispanic Americans were COVID-19–related, as were 18.6% of deaths in American Indians/Alaska Natives. Deaths among Asian persons, at 14.7%, and African Americans, at 13.5%, were closer but still above the national figure, while Whites (9.3%) were the only major subgroup below it, based on data from the National Vital Statistics System.

Age-adjusted death rates tell a somewhat different story: American Indian/Alaska native persons were highest with a rate of 187.8 COVID-19–associated deaths per 100,000 standard population, with Hispanic persons second at 164.3 per 100,000. Blacks were next at 151.1 deaths per 100,000, but Whites had a higher rate (72.5) than did Asian Americans (66.7), the CDC investigators reported.

“During January-December 2020, the estimated 2020 age-adjusted death rate increased for the first time since 2017, with an increase of 15.9% compared with 2019, from 715.2 to 828.7 deaths per 100,000 population,” they wrote, noting that “certain categories of race (i.e., AI/AN and Asian) and Hispanic ethnicity reported on death certificates might have been misclassified, possibly resulting in underestimates of death rates for some groups.”

[email protected]

COVID-19 was the third-leading cause of death in the United States in 2020, but that mortality burden did not fall evenly along racial/ethnic lines, according to a provisional report from the Centers for Disease Control and Prevention.

Only heart disease and cancer caused more deaths than SARS-CoV-2, which took the lives of almost 378,000 Americans last year, Farida B. Ahmad, MPH, and associates at the National Center for Health Statistics noted March 31 in the Morbidity and Mortality Weekly Report.

That represents 11.2% of the almost 3.36 million total deaths recorded in 2020. The racial/ethnics demographics, however, show that 22.4% of all deaths among Hispanic Americans were COVID-19–related, as were 18.6% of deaths in American Indians/Alaska Natives. Deaths among Asian persons, at 14.7%, and African Americans, at 13.5%, were closer but still above the national figure, while Whites (9.3%) were the only major subgroup below it, based on data from the National Vital Statistics System.

Age-adjusted death rates tell a somewhat different story: American Indian/Alaska native persons were highest with a rate of 187.8 COVID-19–associated deaths per 100,000 standard population, with Hispanic persons second at 164.3 per 100,000. Blacks were next at 151.1 deaths per 100,000, but Whites had a higher rate (72.5) than did Asian Americans (66.7), the CDC investigators reported.

“During January-December 2020, the estimated 2020 age-adjusted death rate increased for the first time since 2017, with an increase of 15.9% compared with 2019, from 715.2 to 828.7 deaths per 100,000 population,” they wrote, noting that “certain categories of race (i.e., AI/AN and Asian) and Hispanic ethnicity reported on death certificates might have been misclassified, possibly resulting in underestimates of death rates for some groups.”

[email protected]