MDedge Cardiology

CHICAGO — Patients who are new users of glucagon-like peptide 1 (GLP-1) receptor agonists have a low absolute risk of thyroid cancer, according to a new study presented at the annual meeting of the American Thyroid Association (ATA).

The study, presented by Juan Brito Campana, MBBS, of the Mayo Clinic in Rochester, Minnesota, used Medicare records to perform a secondary analysis of 41,000 adults with type 2 diabetes and moderate cardiovascular risk who were new users of GLP-1 receptor agonists, compared to users of other diabetes medications. 

“We took the innovative approach of applying the methodological rigor of a randomized clinical trial to the very large dataset of observational studies,” said Brito Campana.

The results showed a low absolute risk of thyroid cancer, with only 0.17% of patients in the GLP-1 group developing the disease. However, the data also showed a potential relative increase in risk during the first year of GLP-1 receptor agonist use. 

“This is likely due to increased detection rather than true incidence, as the latency period for thyroid cancer development is typically longer,” Brito Campana said. 

“We also note the limitations of the observational study design, including the short follow-up period and lack of detailed histological data. However, we believe the benefits of GLP-1 receptor agonists likely outweigh the risk of thyroid cancer.”
 

Malignancy in Bethesda III and IV Thyroid Nodules

At the same ATA session, Sapir Nachum Goldberg, MD, of the University of Pennsylvania, Philadelphia, presented the results of a retrospective record review that examined the prevalence of malignancy in Bethesda III and IV thyroid nodules with negative Thyrogen Receptor Signaling (ThyroSeq) version 3 molecular testing results.

Goldberg reported that 87% of patients with ThyroSeq negative subtype results were managed nonoperatively. “Based on our data, the true prevalence of malignancy likely lies between our low and high estimates of 3% and 23%,” she said. “We believe that the prevalence of malignancy may be higher in real-world practice than validation studies.”

Additionally, nodules with “currently negative” or “negative but limited” ThyroSeq results had a higher prevalence of malignancy (7%), compared with those with a “negative” result (2%). Factors like immediate vs delayed surgery, nodule size, and ultrasound pattern did not significantly impact malignancy prevalence.

The study results also indicated that surveillance ultrasonography is not routinely performed in up to one-third of patients, Goldberg said.

She closed by suggesting that colleagues consider the negative subtype in clinical decision-making. For “negative but limited” nodules, repeat the fine needle aspiration and, for “negative” and “currently negative” nodules, consider ultrasound follow-up as per ATA guidelines for Bethesda II cytology, she said.
 

RET-Mutated Medullary Thyroid Cancer

For patients with RET-mutated medullary thyroid cancer, Julien Hadoux, MD, PhD, of Institut de Cancérologie Gustave Roussy, Villejuif, France, presented a combined analysis of the efficacy of the RET inhibitor selpercatinib from the phase 1/2 LIBRETTO-001 and phase 3 LIBRETTO-531 trials.

This post hoc analysis used a combined cohort of 509 patients with RET-mutated advanced or metastatic medullary thyroid cancer who had received selpercatinib in the two trials.

Hadoux reported that robust and durable responses were seen across all mutation groups, including M918T, extracellular cysteine, and an “other” group composed of various uncommon RET mutations. “The median [progression-free survival] PFS was not reached for either the M918T or extracellular groups and it was 51.4 months for the Other group,” he said. 

“Selpercatinib showed superior median PFS vs control, regardless of the RET mutation. This analysis constitutes the largest catalog of RET mutations in medullary thyroid cancers treated with RET-specific inhibitors.”
 

TRK-Fusion Differentiated Thyroid Cancer

Steven Waguespack, MD, of the University of Texas MD Anderson Cancer Center, Houston, shared updated efficacy and safety data from three phase 1/2 pooled clinical trials of the tropomyosin kinase receptor (TRK) inhibitor larotrectinib in thyroid cancer. These data updated results initially published in 2022.

“Larotrectinib continues to demonstrate rapid and durable responses, extended survival, and offers a favorable safety profile in patients with TRK fusion differentiated thyroid cancer, with limited activity in anaplastic thyroid cancer,” Waguespack said. 

“Additionally, in a subset of patients, we identified some acquired on-target NTRK mutations and off-target GNAS and TP53 mutations that may give further insight into mechanisms of resistance.”

The primary endpoint was the investigator-assessed objective response rate (ORR); at 48 months, the ORR was 79% by independent review. The median PFS in patients with TRK fusion differentiated thyroid cancer was 44 months, while the median duration of response was 41 months. The 4-year overall survival rate was 86%.

Waguespack closed with a cautionary note to colleagues: “While circulating tumor DNA next-generation sequencing (NGS) analysis can be used to test for NTRK gene fusions, negative results should be followed up with tissue-based NGS,” he said.

Brito Campana and Goldberg disclosed no relevant financial relationships. Hadoux reported receiving honoraria for speaker engagements, advisory roles, or funding for CME from Eli Lilly, AAA, IPSEN, Roche, Pharma Mar, and EISAI, and research grants from Novartis, Sanofi, and Eli Lilly.

A version of this article appeared on Medscape.com.

CHICAGO — Patients who are new users of glucagon-like peptide 1 (GLP-1) receptor agonists have a low absolute risk of thyroid cancer, according to a new study presented at the annual meeting of the American Thyroid Association (ATA).

The study, presented by Juan Brito Campana, MBBS, of the Mayo Clinic in Rochester, Minnesota, used Medicare records to perform a secondary analysis of 41,000 adults with type 2 diabetes and moderate cardiovascular risk who were new users of GLP-1 receptor agonists, compared to users of other diabetes medications. 

“We took the innovative approach of applying the methodological rigor of a randomized clinical trial to the very large dataset of observational studies,” said Brito Campana.

The results showed a low absolute risk of thyroid cancer, with only 0.17% of patients in the GLP-1 group developing the disease. However, the data also showed a potential relative increase in risk during the first year of GLP-1 receptor agonist use. 

“This is likely due to increased detection rather than true incidence, as the latency period for thyroid cancer development is typically longer,” Brito Campana said. 

“We also note the limitations of the observational study design, including the short follow-up period and lack of detailed histological data. However, we believe the benefits of GLP-1 receptor agonists likely outweigh the risk of thyroid cancer.”
 

Malignancy in Bethesda III and IV Thyroid Nodules

At the same ATA session, Sapir Nachum Goldberg, MD, of the University of Pennsylvania, Philadelphia, presented the results of a retrospective record review that examined the prevalence of malignancy in Bethesda III and IV thyroid nodules with negative Thyrogen Receptor Signaling (ThyroSeq) version 3 molecular testing results.

Goldberg reported that 87% of patients with ThyroSeq negative subtype results were managed nonoperatively. “Based on our data, the true prevalence of malignancy likely lies between our low and high estimates of 3% and 23%,” she said. “We believe that the prevalence of malignancy may be higher in real-world practice than validation studies.”

Additionally, nodules with “currently negative” or “negative but limited” ThyroSeq results had a higher prevalence of malignancy (7%), compared with those with a “negative” result (2%). Factors like immediate vs delayed surgery, nodule size, and ultrasound pattern did not significantly impact malignancy prevalence.

The study results also indicated that surveillance ultrasonography is not routinely performed in up to one-third of patients, Goldberg said.

She closed by suggesting that colleagues consider the negative subtype in clinical decision-making. For “negative but limited” nodules, repeat the fine needle aspiration and, for “negative” and “currently negative” nodules, consider ultrasound follow-up as per ATA guidelines for Bethesda II cytology, she said.
 

RET-Mutated Medullary Thyroid Cancer

For patients with RET-mutated medullary thyroid cancer, Julien Hadoux, MD, PhD, of Institut de Cancérologie Gustave Roussy, Villejuif, France, presented a combined analysis of the efficacy of the RET inhibitor selpercatinib from the phase 1/2 LIBRETTO-001 and phase 3 LIBRETTO-531 trials.

This post hoc analysis used a combined cohort of 509 patients with RET-mutated advanced or metastatic medullary thyroid cancer who had received selpercatinib in the two trials.

Hadoux reported that robust and durable responses were seen across all mutation groups, including M918T, extracellular cysteine, and an “other” group composed of various uncommon RET mutations. “The median [progression-free survival] PFS was not reached for either the M918T or extracellular groups and it was 51.4 months for the Other group,” he said. 

“Selpercatinib showed superior median PFS vs control, regardless of the RET mutation. This analysis constitutes the largest catalog of RET mutations in medullary thyroid cancers treated with RET-specific inhibitors.”
 

TRK-Fusion Differentiated Thyroid Cancer

Steven Waguespack, MD, of the University of Texas MD Anderson Cancer Center, Houston, shared updated efficacy and safety data from three phase 1/2 pooled clinical trials of the tropomyosin kinase receptor (TRK) inhibitor larotrectinib in thyroid cancer. These data updated results initially published in 2022.

“Larotrectinib continues to demonstrate rapid and durable responses, extended survival, and offers a favorable safety profile in patients with TRK fusion differentiated thyroid cancer, with limited activity in anaplastic thyroid cancer,” Waguespack said. 

“Additionally, in a subset of patients, we identified some acquired on-target NTRK mutations and off-target GNAS and TP53 mutations that may give further insight into mechanisms of resistance.”

The primary endpoint was the investigator-assessed objective response rate (ORR); at 48 months, the ORR was 79% by independent review. The median PFS in patients with TRK fusion differentiated thyroid cancer was 44 months, while the median duration of response was 41 months. The 4-year overall survival rate was 86%.

Waguespack closed with a cautionary note to colleagues: “While circulating tumor DNA next-generation sequencing (NGS) analysis can be used to test for NTRK gene fusions, negative results should be followed up with tissue-based NGS,” he said.

Brito Campana and Goldberg disclosed no relevant financial relationships. Hadoux reported receiving honoraria for speaker engagements, advisory roles, or funding for CME from Eli Lilly, AAA, IPSEN, Roche, Pharma Mar, and EISAI, and research grants from Novartis, Sanofi, and Eli Lilly.

A version of this article appeared on Medscape.com.

CHICAGO — Patients who are new users of glucagon-like peptide 1 (GLP-1) receptor agonists have a low absolute risk of thyroid cancer, according to a new study presented at the annual meeting of the American Thyroid Association (ATA).

The study, presented by Juan Brito Campana, MBBS, of the Mayo Clinic in Rochester, Minnesota, used Medicare records to perform a secondary analysis of 41,000 adults with type 2 diabetes and moderate cardiovascular risk who were new users of GLP-1 receptor agonists, compared to users of other diabetes medications. 

“We took the innovative approach of applying the methodological rigor of a randomized clinical trial to the very large dataset of observational studies,” said Brito Campana.

The results showed a low absolute risk of thyroid cancer, with only 0.17% of patients in the GLP-1 group developing the disease. However, the data also showed a potential relative increase in risk during the first year of GLP-1 receptor agonist use. 

“This is likely due to increased detection rather than true incidence, as the latency period for thyroid cancer development is typically longer,” Brito Campana said. 

“We also note the limitations of the observational study design, including the short follow-up period and lack of detailed histological data. However, we believe the benefits of GLP-1 receptor agonists likely outweigh the risk of thyroid cancer.”
 

Malignancy in Bethesda III and IV Thyroid Nodules

At the same ATA session, Sapir Nachum Goldberg, MD, of the University of Pennsylvania, Philadelphia, presented the results of a retrospective record review that examined the prevalence of malignancy in Bethesda III and IV thyroid nodules with negative Thyrogen Receptor Signaling (ThyroSeq) version 3 molecular testing results.

Goldberg reported that 87% of patients with ThyroSeq negative subtype results were managed nonoperatively. “Based on our data, the true prevalence of malignancy likely lies between our low and high estimates of 3% and 23%,” she said. “We believe that the prevalence of malignancy may be higher in real-world practice than validation studies.”

Additionally, nodules with “currently negative” or “negative but limited” ThyroSeq results had a higher prevalence of malignancy (7%), compared with those with a “negative” result (2%). Factors like immediate vs delayed surgery, nodule size, and ultrasound pattern did not significantly impact malignancy prevalence.

The study results also indicated that surveillance ultrasonography is not routinely performed in up to one-third of patients, Goldberg said.

She closed by suggesting that colleagues consider the negative subtype in clinical decision-making. For “negative but limited” nodules, repeat the fine needle aspiration and, for “negative” and “currently negative” nodules, consider ultrasound follow-up as per ATA guidelines for Bethesda II cytology, she said.
 

RET-Mutated Medullary Thyroid Cancer

For patients with RET-mutated medullary thyroid cancer, Julien Hadoux, MD, PhD, of Institut de Cancérologie Gustave Roussy, Villejuif, France, presented a combined analysis of the efficacy of the RET inhibitor selpercatinib from the phase 1/2 LIBRETTO-001 and phase 3 LIBRETTO-531 trials.

This post hoc analysis used a combined cohort of 509 patients with RET-mutated advanced or metastatic medullary thyroid cancer who had received selpercatinib in the two trials.

Hadoux reported that robust and durable responses were seen across all mutation groups, including M918T, extracellular cysteine, and an “other” group composed of various uncommon RET mutations. “The median [progression-free survival] PFS was not reached for either the M918T or extracellular groups and it was 51.4 months for the Other group,” he said. 

“Selpercatinib showed superior median PFS vs control, regardless of the RET mutation. This analysis constitutes the largest catalog of RET mutations in medullary thyroid cancers treated with RET-specific inhibitors.”
 

TRK-Fusion Differentiated Thyroid Cancer

Steven Waguespack, MD, of the University of Texas MD Anderson Cancer Center, Houston, shared updated efficacy and safety data from three phase 1/2 pooled clinical trials of the tropomyosin kinase receptor (TRK) inhibitor larotrectinib in thyroid cancer. These data updated results initially published in 2022.

“Larotrectinib continues to demonstrate rapid and durable responses, extended survival, and offers a favorable safety profile in patients with TRK fusion differentiated thyroid cancer, with limited activity in anaplastic thyroid cancer,” Waguespack said. 

“Additionally, in a subset of patients, we identified some acquired on-target NTRK mutations and off-target GNAS and TP53 mutations that may give further insight into mechanisms of resistance.”

The primary endpoint was the investigator-assessed objective response rate (ORR); at 48 months, the ORR was 79% by independent review. The median PFS in patients with TRK fusion differentiated thyroid cancer was 44 months, while the median duration of response was 41 months. The 4-year overall survival rate was 86%.

Waguespack closed with a cautionary note to colleagues: “While circulating tumor DNA next-generation sequencing (NGS) analysis can be used to test for NTRK gene fusions, negative results should be followed up with tissue-based NGS,” he said.

Brito Campana and Goldberg disclosed no relevant financial relationships. Hadoux reported receiving honoraria for speaker engagements, advisory roles, or funding for CME from Eli Lilly, AAA, IPSEN, Roche, Pharma Mar, and EISAI, and research grants from Novartis, Sanofi, and Eli Lilly.

A version of this article appeared on Medscape.com.

BOSTON — Social adversity is associated with worse survival among patients with pulmonary hypertension (PH), according to a new retrospective study of a New York City population. Among HIV+ patients with heart failure, PH was associated with about a threefold increase in all-cause mortality, but that risk increased to about sevenfold when social adversity, identified by a licensed social worker, was also present.

A sub-analysis of both HIV+ and HIV– patients showed worse mortality outcomes with social adversity in both groups.

“Almost the majority of patients that we treat have either some social adversity or no insurance or are undocumented, so as a group of residents, we decided to study the impact of these factors on their health and the care that can be provided. We started using the two cohorts and now we keep it going with every new resident,” said Luca Biavati, MD, who presented the study at the CHEST Annual Meeting.

“The presence of any form of socioeconomic disadvantage is negatively impacting care and for a large part of the population, there are some factors that could probably be addressed by either an institutional or hospital policy,” said Dr. Biavati, who is an internal medicine resident at Jacobi Medical Center, New York.

Other factors are more difficult to address, such as lack of education. “[Some patients] don’t understand the gravity of their issue and medical condition until it’s too late, and then they’re not fit enough for the treatment, or just because of the social situation, they cannot qualify for advanced therapies,” said Dr. Biavati.

The researchers established two cohorts: One consisting of patients with HIV and heart failure who may or may not have had PH and one comprising patients with PH with or without HIV and heart failure. In the HIV/heart failure group, PH without social adversity was associated with a nearly threefold increase in all-cause mortality (hazard ratio [HR], 2.83; P = .004), whereas PH with social adversity was linked to a more than sevenfold increase in all-cause mortality (HR, 7.14; P < .001). Social adversity without PA was associated with a more than fourfold increase (HR, 4.47; P < .001).

Within the PH cohort, social adversity was associated with lower survival (P < .001). When the researchers broke down the results by types of social adversity, they found statistically significant relationships between greater mortality risk and economic instability within the HIV+ population (HR, 2.59; P = .040), transportation issues within the HIV– population (HR, 12.8; P < .001), and lack of social or family support within both the HIV– (HR, 5.49; P < .001) and the HIV+ population (HR, 2.03; P = .028). 

The research has prompted interventions, which are now being studied at the institution, according to Dr. Biavati. “We have a policy of giving medications in bags when we discharge a patient with a social adversity. We literally go to the pharmacy, bring up the bag of medication, and we [put it] in their hands before they leave the hospital. They get a 1- or 3-month supply, depending on the medication, and then we usually discharge them with a clinical appointment already scheduled with either a pulmonary or primary care provider, and we usually call them before every appointment to confirm that they’re coming. That increases the chances of some success, but there’s still a very long way to go,” said Dr. Biavati.

Dr. Biavati was blinded to the results of the intervention, so he could not report on whether it was working. “But I can tell you that I’ve had busier clinics, so hopefully that means that they’re showing up more,” he said.

The problem is complex, according to Sandeep Jain, MD, who moderated the session. “Social adversity means lack of education. Lack of education means lack of compliance. Lack of compliance means what can you do if people are not taking medications? So it’s all matched together. It’s all lack of education and lack of money, lack of family support. And these drugs they have to take every single day. It’s not that easy. It’s very easy for us to say I had antiretroviral treatment for 6 months. It is almost impossible to continue regular treatment for that long [for a patient with social adversity]. You can’t blame them if they aren’t taking treatments. It’s very difficult for them,” said Dr. Jain.

That underscores the need for interventions that can address the needs of patients with social adversity. “We have to [practice] medicine considering the social situation of the patient and not just the medicine that we study in books. That’s kind of what we are faced with every day. We have therapies, and then life happens. It’s much harder to care for those patients,” said Dr. Biavati.

Dr. Biavati and Dr. Jain reported no relevant financial relationships.
 

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

BOSTON — Social adversity is associated with worse survival among patients with pulmonary hypertension (PH), according to a new retrospective study of a New York City population. Among HIV+ patients with heart failure, PH was associated with about a threefold increase in all-cause mortality, but that risk increased to about sevenfold when social adversity, identified by a licensed social worker, was also present.

A sub-analysis of both HIV+ and HIV– patients showed worse mortality outcomes with social adversity in both groups.

“Almost the majority of patients that we treat have either some social adversity or no insurance or are undocumented, so as a group of residents, we decided to study the impact of these factors on their health and the care that can be provided. We started using the two cohorts and now we keep it going with every new resident,” said Luca Biavati, MD, who presented the study at the CHEST Annual Meeting.

“The presence of any form of socioeconomic disadvantage is negatively impacting care and for a large part of the population, there are some factors that could probably be addressed by either an institutional or hospital policy,” said Dr. Biavati, who is an internal medicine resident at Jacobi Medical Center, New York.

Other factors are more difficult to address, such as lack of education. “[Some patients] don’t understand the gravity of their issue and medical condition until it’s too late, and then they’re not fit enough for the treatment, or just because of the social situation, they cannot qualify for advanced therapies,” said Dr. Biavati.

The researchers established two cohorts: One consisting of patients with HIV and heart failure who may or may not have had PH and one comprising patients with PH with or without HIV and heart failure. In the HIV/heart failure group, PH without social adversity was associated with a nearly threefold increase in all-cause mortality (hazard ratio [HR], 2.83; P = .004), whereas PH with social adversity was linked to a more than sevenfold increase in all-cause mortality (HR, 7.14; P < .001). Social adversity without PA was associated with a more than fourfold increase (HR, 4.47; P < .001).

Within the PH cohort, social adversity was associated with lower survival (P < .001). When the researchers broke down the results by types of social adversity, they found statistically significant relationships between greater mortality risk and economic instability within the HIV+ population (HR, 2.59; P = .040), transportation issues within the HIV– population (HR, 12.8; P < .001), and lack of social or family support within both the HIV– (HR, 5.49; P < .001) and the HIV+ population (HR, 2.03; P = .028). 

The research has prompted interventions, which are now being studied at the institution, according to Dr. Biavati. “We have a policy of giving medications in bags when we discharge a patient with a social adversity. We literally go to the pharmacy, bring up the bag of medication, and we [put it] in their hands before they leave the hospital. They get a 1- or 3-month supply, depending on the medication, and then we usually discharge them with a clinical appointment already scheduled with either a pulmonary or primary care provider, and we usually call them before every appointment to confirm that they’re coming. That increases the chances of some success, but there’s still a very long way to go,” said Dr. Biavati.

Dr. Biavati was blinded to the results of the intervention, so he could not report on whether it was working. “But I can tell you that I’ve had busier clinics, so hopefully that means that they’re showing up more,” he said.

The problem is complex, according to Sandeep Jain, MD, who moderated the session. “Social adversity means lack of education. Lack of education means lack of compliance. Lack of compliance means what can you do if people are not taking medications? So it’s all matched together. It’s all lack of education and lack of money, lack of family support. And these drugs they have to take every single day. It’s not that easy. It’s very easy for us to say I had antiretroviral treatment for 6 months. It is almost impossible to continue regular treatment for that long [for a patient with social adversity]. You can’t blame them if they aren’t taking treatments. It’s very difficult for them,” said Dr. Jain.

That underscores the need for interventions that can address the needs of patients with social adversity. “We have to [practice] medicine considering the social situation of the patient and not just the medicine that we study in books. That’s kind of what we are faced with every day. We have therapies, and then life happens. It’s much harder to care for those patients,” said Dr. Biavati.

Dr. Biavati and Dr. Jain reported no relevant financial relationships.
 

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

BOSTON — Social adversity is associated with worse survival among patients with pulmonary hypertension (PH), according to a new retrospective study of a New York City population. Among HIV+ patients with heart failure, PH was associated with about a threefold increase in all-cause mortality, but that risk increased to about sevenfold when social adversity, identified by a licensed social worker, was also present.

A sub-analysis of both HIV+ and HIV– patients showed worse mortality outcomes with social adversity in both groups.

“Almost the majority of patients that we treat have either some social adversity or no insurance or are undocumented, so as a group of residents, we decided to study the impact of these factors on their health and the care that can be provided. We started using the two cohorts and now we keep it going with every new resident,” said Luca Biavati, MD, who presented the study at the CHEST Annual Meeting.

“The presence of any form of socioeconomic disadvantage is negatively impacting care and for a large part of the population, there are some factors that could probably be addressed by either an institutional or hospital policy,” said Dr. Biavati, who is an internal medicine resident at Jacobi Medical Center, New York.

Other factors are more difficult to address, such as lack of education. “[Some patients] don’t understand the gravity of their issue and medical condition until it’s too late, and then they’re not fit enough for the treatment, or just because of the social situation, they cannot qualify for advanced therapies,” said Dr. Biavati.

The researchers established two cohorts: One consisting of patients with HIV and heart failure who may or may not have had PH and one comprising patients with PH with or without HIV and heart failure. In the HIV/heart failure group, PH without social adversity was associated with a nearly threefold increase in all-cause mortality (hazard ratio [HR], 2.83; P = .004), whereas PH with social adversity was linked to a more than sevenfold increase in all-cause mortality (HR, 7.14; P < .001). Social adversity without PA was associated with a more than fourfold increase (HR, 4.47; P < .001).

Within the PH cohort, social adversity was associated with lower survival (P < .001). When the researchers broke down the results by types of social adversity, they found statistically significant relationships between greater mortality risk and economic instability within the HIV+ population (HR, 2.59; P = .040), transportation issues within the HIV– population (HR, 12.8; P < .001), and lack of social or family support within both the HIV– (HR, 5.49; P < .001) and the HIV+ population (HR, 2.03; P = .028). 

The research has prompted interventions, which are now being studied at the institution, according to Dr. Biavati. “We have a policy of giving medications in bags when we discharge a patient with a social adversity. We literally go to the pharmacy, bring up the bag of medication, and we [put it] in their hands before they leave the hospital. They get a 1- or 3-month supply, depending on the medication, and then we usually discharge them with a clinical appointment already scheduled with either a pulmonary or primary care provider, and we usually call them before every appointment to confirm that they’re coming. That increases the chances of some success, but there’s still a very long way to go,” said Dr. Biavati.

Dr. Biavati was blinded to the results of the intervention, so he could not report on whether it was working. “But I can tell you that I’ve had busier clinics, so hopefully that means that they’re showing up more,” he said.

The problem is complex, according to Sandeep Jain, MD, who moderated the session. “Social adversity means lack of education. Lack of education means lack of compliance. Lack of compliance means what can you do if people are not taking medications? So it’s all matched together. It’s all lack of education and lack of money, lack of family support. And these drugs they have to take every single day. It’s not that easy. It’s very easy for us to say I had antiretroviral treatment for 6 months. It is almost impossible to continue regular treatment for that long [for a patient with social adversity]. You can’t blame them if they aren’t taking treatments. It’s very difficult for them,” said Dr. Jain.

That underscores the need for interventions that can address the needs of patients with social adversity. “We have to [practice] medicine considering the social situation of the patient and not just the medicine that we study in books. That’s kind of what we are faced with every day. We have therapies, and then life happens. It’s much harder to care for those patients,” said Dr. Biavati.

Dr. Biavati and Dr. Jain reported no relevant financial relationships.
 

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

BOSTON — Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

BOSTON — Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

BOSTON — Patients with COPD who have exacerbations requiring hospitalization should be monitored for cardiac arrhythmias, investigators said.

This recommendation is based on results of a study of medical records showing that among more than 20,000 hospitalizations for patients with COPD without concurrent heart failure (HF), 40% patients had at least 6 minutes of daily atrial fibrillation (AF) burden, and nearly half of these patients had at least an hour of daily AF burden; patients with COPD and concurrent HF had similar daily AF burdens, reported Trent Fischer, MD, MS, senior principal scientist at Medtronic in Minneapolis.

“We can conclude that AF burden increases in the weeks after a hospitalization for COPD if they don’t have a concurrent diagnosis of heart failure. Also, having concurrent heart failure increases the risk of atrial fibrillation and increases the atrial fibrillation burden around the time of COPD hospitalization,” he said in a rapid-fire oral abstract session at the CHEST Annual Meeting.

The findings indicated a need for increased vigilance for AF around the time of a serious COPD exacerbation and may explain at least some of the increased risks for stroke observed in patients who are hospitalized for COPD exacerbations, he said.
 

Retrospective Study

Dr. Fischer and colleagues conducted the study to characterize the AF burden among patients both with and without HF who were hospitalized for acute COPD exacerbation and to determine the temporal relationship between AF and hospitalization.

They drew data from 2007 through 2021 on patients with implantable cardioverter defibrillators, cardiac resynchronization therapy devices, pacemakers, and implantable cardiac monitors, using the Optum de-identified electronic health record dataset linked with Medtronic’s CareLink database to conduct a retrospective analysis.

They looked at admissions for COPD linked to available device diagnostic parameters between 30 days prior to and 60 days after admission for COPD.

They identified a total of 20,056 COPD hospitalizations for patients with concurrent HF and 3877 for those without HF.

Among patients with HF, 43% had a daily AF burden of at least 6 minutes, and 22% had at least 1 hour of irregular rhythms. Among patients without HF, 40% had at least 6 minutes of irregular rhythms daily, and 18% had at least 1 hour.

Among patients with HF, the daily average AF burden increased from a baseline of 158 min/d 30 days before an admission to 170 min/d at admission, returning to baseline by 20 days after hospitalization.

For patients without HF, the AF burden increased from 107 min/d at baseline to 113 min/d during hospitalization and returned to baseline by 20 days after hospitalization.
 

Confounding Factor?

In the Q&A, session moderator Krishna Sundar, MBBS, MD, FCCP, a pulmonary, sleep medicine, and critical care medicine specialist at St. John’s Medical Center in Jackson, Wyoming, said that when patients with HF get admitted for COPD exacerbations, their HF typically worsens and asked Dr. Fischer how he could tell the difference.

“I know there’s a lot of interaction between heart failure and COPD. They’re well-know comorbidities, and the exacerbation of one can bring on worsening of the other. At least with this database, we can’t really tease out any sort of differences,” Dr. Fischer replied.

“I think that a diagnosis of COPD exacerbation is pretty well laid out, but it’s sometimes difficult to separate worsening of heart failure in these patients, and often these patients get treated for both problems. It’s clear that it’s the heart failure patients who are having more atrial fibrillation episodes, which is not surprising, but the question is how much is the COPD exacerbation contributing to the atrial fibrillation?” said Dr. Sundar.

The study was supported by Medtronic. Dr. Fischer is employed by the company. Dr. Sundar reported no relevant financial relationships.



A version of this article appeared on Medscape.com.

Despite some recent progress in compensation equity, women in medicine continue to be paid significantly lower salaries than men.

According to the Female Compensation Report 2024 by Medscape, male doctors of any kind earned an average salary of about $400,000, whereas female doctors earned approximately $309,000 — a 29% gap.

The report analyzed survey data from 7000 practicing physicians who were recruited over a 4-month period starting in October 2023. The respondents comprised roughly 60% women representing over 29 specialties.

In the 2022 report, the pay gap between the genders was 32%. But some women in the field argued substantial headway is still needed.

“You can try and pick apart the data, but I’d say we’re not really making progress,” said Susan T. Hingle, MD, an internist in Illinois and president of the American Medical Women’s Association. “A decline by a couple of percentage points is not significantly addressing this pay gap that over a lifetime is huge, can be millions of dollars.”

The gender gap was narrower among female primary care physicians (PCPs) vs medical specialists. Female PCPs earned around $253,000 per year, whereas male PCPs earned about $295,000 per year. Hingle suggested that female PCPs may enjoy more pay equity because health systems have a harder time filling these positions.

On the other hand, the gap for specialists rose from 27% in 2022 to 31% in 2023. Differences in how aggressively women and men negotiate compensation packages may play a role, said Hingle.

“Taking negotiation out of the equation would be progress to me,” said Hingle.

Pay disparity did not appear to be the result of time spent on the job — female doctors reported an average of 49 work hours per week, whereas their male counterparts reported 50 work hours per week.

Meanwhile, the pay gap progressively worsened over time. Among doctors aged 28-34 years, men earned an average of $53,000 more than women. By ages 46-49, men earned an average of $157,000 more than women.

“I had to take my employer to court to get equal compensation, sad as it is to say,” said a hospitalist in North Carolina.

Nearly 60% of women surveyed felt they were not being paid fairly for their efforts, up from less than half reported in Medscape’s 2021 report. Hingle said that this figure may not only reflect sentiments about the compensation gap, but also less support on the job, including fewer physician assistants (PAs), nurses, and administrative staff.

“At my job, I do the work of multiple people,” said a survey respondent. “Junior resident, senior resident, social worker, nurse practitioner, PA — as well as try to be a teacher, researcher, [and] an excellent doctor and have the time to make patients feel as if they are not in a rush.”

Roughly 30% of women physicians said they would not choose to go into medicine again if given the chance compared with 26% of male physicians.

“Gender inequities in our profession have a direct impact,” said Shikha Jain, MD, an oncologist in Chicago and founder of the Women in Medicine nonprofit. “I think women in general don’t feel valued in the care they’re providing.” 

Jain cited bullying, harassment, and fewer opportunities for leadership and recognition as factors beyond pay that affect female physicians’ feelings of being valued.

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

Despite some recent progress in compensation equity, women in medicine continue to be paid significantly lower salaries than men.

According to the Female Compensation Report 2024 by Medscape, male doctors of any kind earned an average salary of about $400,000, whereas female doctors earned approximately $309,000 — a 29% gap.

The report analyzed survey data from 7000 practicing physicians who were recruited over a 4-month period starting in October 2023. The respondents comprised roughly 60% women representing over 29 specialties.

In the 2022 report, the pay gap between the genders was 32%. But some women in the field argued substantial headway is still needed.

“You can try and pick apart the data, but I’d say we’re not really making progress,” said Susan T. Hingle, MD, an internist in Illinois and president of the American Medical Women’s Association. “A decline by a couple of percentage points is not significantly addressing this pay gap that over a lifetime is huge, can be millions of dollars.”

The gender gap was narrower among female primary care physicians (PCPs) vs medical specialists. Female PCPs earned around $253,000 per year, whereas male PCPs earned about $295,000 per year. Hingle suggested that female PCPs may enjoy more pay equity because health systems have a harder time filling these positions.

On the other hand, the gap for specialists rose from 27% in 2022 to 31% in 2023. Differences in how aggressively women and men negotiate compensation packages may play a role, said Hingle.

“Taking negotiation out of the equation would be progress to me,” said Hingle.

Pay disparity did not appear to be the result of time spent on the job — female doctors reported an average of 49 work hours per week, whereas their male counterparts reported 50 work hours per week.

Meanwhile, the pay gap progressively worsened over time. Among doctors aged 28-34 years, men earned an average of $53,000 more than women. By ages 46-49, men earned an average of $157,000 more than women.

“I had to take my employer to court to get equal compensation, sad as it is to say,” said a hospitalist in North Carolina.

Nearly 60% of women surveyed felt they were not being paid fairly for their efforts, up from less than half reported in Medscape’s 2021 report. Hingle said that this figure may not only reflect sentiments about the compensation gap, but also less support on the job, including fewer physician assistants (PAs), nurses, and administrative staff.

“At my job, I do the work of multiple people,” said a survey respondent. “Junior resident, senior resident, social worker, nurse practitioner, PA — as well as try to be a teacher, researcher, [and] an excellent doctor and have the time to make patients feel as if they are not in a rush.”

Roughly 30% of women physicians said they would not choose to go into medicine again if given the chance compared with 26% of male physicians.

“Gender inequities in our profession have a direct impact,” said Shikha Jain, MD, an oncologist in Chicago and founder of the Women in Medicine nonprofit. “I think women in general don’t feel valued in the care they’re providing.” 

Jain cited bullying, harassment, and fewer opportunities for leadership and recognition as factors beyond pay that affect female physicians’ feelings of being valued.

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

Despite some recent progress in compensation equity, women in medicine continue to be paid significantly lower salaries than men.

According to the Female Compensation Report 2024 by Medscape, male doctors of any kind earned an average salary of about $400,000, whereas female doctors earned approximately $309,000 — a 29% gap.

The report analyzed survey data from 7000 practicing physicians who were recruited over a 4-month period starting in October 2023. The respondents comprised roughly 60% women representing over 29 specialties.

In the 2022 report, the pay gap between the genders was 32%. But some women in the field argued substantial headway is still needed.

“You can try and pick apart the data, but I’d say we’re not really making progress,” said Susan T. Hingle, MD, an internist in Illinois and president of the American Medical Women’s Association. “A decline by a couple of percentage points is not significantly addressing this pay gap that over a lifetime is huge, can be millions of dollars.”

The gender gap was narrower among female primary care physicians (PCPs) vs medical specialists. Female PCPs earned around $253,000 per year, whereas male PCPs earned about $295,000 per year. Hingle suggested that female PCPs may enjoy more pay equity because health systems have a harder time filling these positions.

On the other hand, the gap for specialists rose from 27% in 2022 to 31% in 2023. Differences in how aggressively women and men negotiate compensation packages may play a role, said Hingle.

“Taking negotiation out of the equation would be progress to me,” said Hingle.

Pay disparity did not appear to be the result of time spent on the job — female doctors reported an average of 49 work hours per week, whereas their male counterparts reported 50 work hours per week.

Meanwhile, the pay gap progressively worsened over time. Among doctors aged 28-34 years, men earned an average of $53,000 more than women. By ages 46-49, men earned an average of $157,000 more than women.

“I had to take my employer to court to get equal compensation, sad as it is to say,” said a hospitalist in North Carolina.

Nearly 60% of women surveyed felt they were not being paid fairly for their efforts, up from less than half reported in Medscape’s 2021 report. Hingle said that this figure may not only reflect sentiments about the compensation gap, but also less support on the job, including fewer physician assistants (PAs), nurses, and administrative staff.

“At my job, I do the work of multiple people,” said a survey respondent. “Junior resident, senior resident, social worker, nurse practitioner, PA — as well as try to be a teacher, researcher, [and] an excellent doctor and have the time to make patients feel as if they are not in a rush.”

Roughly 30% of women physicians said they would not choose to go into medicine again if given the chance compared with 26% of male physicians.

“Gender inequities in our profession have a direct impact,” said Shikha Jain, MD, an oncologist in Chicago and founder of the Women in Medicine nonprofit. “I think women in general don’t feel valued in the care they’re providing.” 

Jain cited bullying, harassment, and fewer opportunities for leadership and recognition as factors beyond pay that affect female physicians’ feelings of being valued.

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

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

When my normally adorable cat Biscuit bit my ankle in a playful stalking exercise gone wrong, I washed it with soap and some rubbing alcohol, slapped on a Band-Aid, and went about my day.

The next morning, when it was swollen, I told myself it was probably just a hematoma and went about my day.

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA Network

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

When my normally adorable cat Biscuit bit my ankle in a playful stalking exercise gone wrong, I washed it with soap and some rubbing alcohol, slapped on a Band-Aid, and went about my day.

The next morning, when it was swollen, I told myself it was probably just a hematoma and went about my day.

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA Network

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

When my normally adorable cat Biscuit bit my ankle in a playful stalking exercise gone wrong, I washed it with soap and some rubbing alcohol, slapped on a Band-Aid, and went about my day.

The next morning, when it was swollen, I told myself it was probably just a hematoma and went about my day.

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

Dr. Wilson

JAMA Network

Dr. Wilson

Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

A study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

A study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

In seconds, Ravi Parikh, MD, an oncologist at the Emory University School of Medicine in Atlanta, had a summary of his patient’s entire medical history. Normally, Parikh skimmed the cumbersome files before seeing a patient. However, the artificial intelligence (AI) tool his institution was testing could list the highlights he needed in a fraction of the time.

“On the whole, I like it ... it saves me time,” Parikh said of the tool. “But I’d be lying if I told you it was perfect all the time. It’s interpreting the [patient] history in some ways that may be inaccurate,” he said.

Within the first week of testing the tool, Parikh started to notice that the large language model (LLM) made a particular mistake in his patients with prostate cancer. If their prostate-specific antigen test results came back slightly elevated — which is part of normal variation — the LLM recorded it as disease progression. Because Parikh reviews all his notes — with or without using an AI tool — after a visit, he easily caught the mistake before it was added to the chart. “The problem, I think, is if these mistakes go under the hood,” he said.

In the data science world, these mistakes are called hallucinations. And a growing body of research suggests they’re happening more frequently than is safe for healthcare. The industry promised LLMs would alleviate administrative burden and reduce physician burnout. But so far, studies show these AI-tool mistakes often create more work for doctors, not less. To truly help physicians and be safe for patients, some experts say healthcare needs to build its own LLMs from the ground up. And all agree that the field desperately needs a way to vet these algorithms more thoroughly.
 

Prone to Error

Right now, “I think the industry is focused on taking existing LLMs and forcing them into usage for healthcare,” said Nigam H. Shah, MBBS, PhD, chief data scientist for Stanford Health. However, the value of deploying general LLMs in the healthcare space is questionable. “People are starting to wonder if we’re using these tools wrong,” he told this news organization.

In 2023, Shah and his colleagues evaluated seven LLMs on their ability to answer electronic health record–based questions. For realistic tasks, the error rate in the best cases was about 35%, he said. “To me, that rate seems a bit high ... to adopt for routine use.”

A study earlier this year by the UC San Diego School of Medicine showed that using LLMs to respond to patient messages increased the time doctors spent on messages. And this summer, a study by the clinical AI firm Mendel found that when GPT-4o or Llama-3 were used to summarize patient medical records, almost every summary contained at least one type of hallucination.

“We’ve seen cases where a patient does have drug allergies, but the system says ‘no known drug allergies’ ” in the medical history summary, said Wael Salloum, PhD, cofounder and chief science officer at Mendel. “That’s a serious hallucination.” And if physicians have to constantly verify what the system is telling them, that “defeats the purpose [of summarization],” he said.
 

A Higher Quality Diet

Part of the trouble with LLMs is that there’s just not enough high-quality information to feed them. The algorithms are insatiable, requiring vast swaths of data for training. GPT-3.5, for instance, was trained on 570 GB of data from the internet, more than 300 billion words. And to train GPT-4o, OpenAI reportedly transcribed more than 1 million hours of YouTube content.

However, the strategies that built these general LLMs don’t always translate well to healthcare. The internet is full of low-quality or misleading health information from wellness sites and supplement advertisements. And even data that are trustworthy, like the millions of clinical studies and the US Food and Drug Administration (FDA) statements, can be outdated, Salloum said. And “an LLM in training can’t distinguish good from bad,” he added.

The good news is that clinicians don’t rely on controversial information in the real world. Medical knowledge is standardized. “Healthcare is a domain rich with explicit knowledge,” Salloum said. So there’s potential to build a more reliable LLM that is guided by robust medical standards and guidelines.

It’s possible that healthcare could use small language models, which are LLM’s pocket-sized cousins, and perform tasks needing only bite-sized datasets requiring fewer resources and easier fine-tuning, according to Microsoft’s website. Shah said training these smaller models on real medical data might be an option, like an LLM meant to respond to patient messages that could be trained with real messages sent by physicians.

Several groups are already working on databases of standardized human medical knowledge or real physician responses. “Perhaps that will work better than using LLMs trained on the general internet. Those studies need to be done,” Shah said.

Jon Tamir, assistant professor of electrical and computer engineering and co-lead of the AI Health Lab at The University of Texas at Austin, said, “The community has recognized that we are entering a new era of AI where the dataset itself is the most important aspect. We need training sets that are highly curated and highly specialized.

“If the dataset is highly specialized, it will definitely help reduce hallucinations,” he said.
 

Cutting Overconfidence

A major problem with LLM mistakes is that they are often hard to detect. Hallucinations can be highly convincing even if they’re highly inaccurate, according to Tamir.

When Shah, for instance, was recently testing an LLM on de-identified patient data, he asked the LLM which blood test the patient last had. The model responded with “complete blood count [CBC].” But when he asked for the results, the model gave him white blood count and other values. “Turns out that record did not have a CBC done at all! The result was entirely made up,” he said.

Making healthcare LLMs safer and more reliable will mean training AI to acknowledge potential mistakes and uncertainty. Existing LLMs are trained to project confidence and produce a lot of answers, even when there isn’t one, Salloum said. They rarely respond with “I don’t know” even when their prediction has low confidence, he added.

Healthcare stands to benefit from a system that highlights uncertainty and potential errors. For instance, if a patient’s history shows they have smoked, stopped smoking, vaped, and started smoking again. The LLM might call them a smoker but flag the comment as uncertain because the chronology is complicated, Salloum said.

Tamir added that this strategy could improve LLM and doctor collaboration by honing in on where human expertise is needed most.
 

Too Little Evaluation

For any improvement strategy to work, LLMs — and all AI-assisted healthcare tools — first need a better evaluation framework. So far, LLMs have “been used in really exciting ways but not really well-vetted ways,” Tamir said.

While some AI-assisted tools, particularly in medical imaging, have undergone rigorous FDA evaluations and earned approval, most haven’t. And because the FDA only regulates algorithms that are considered medical devices, Parikh said that most LLMs used for administrative tasks and efficiency don’t fall under the regulatory agency’s purview.

But these algorithms still have access to patient information and can directly influence patient and doctor decisions. Third-party regulatory agencies are expected to emerge, but it’s still unclear who those will be. Before developers can build a safer and more efficient LLM for healthcare, they’ll need better guidelines and guardrails. “Unless we figure out evaluation, how would we know whether the healthcare-appropriate large language models are better or worse?” Shah asked.
 

A version of this article appeared on Medscape.com.

From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

From the largest healthcare companies to solo practices, just every organization in medicine faces a risk for costly cyberattacks. In recent years, hackers have threatened to release the personal information of patients and employees — or paralyze online systems — unless they’re paid a ransom.

Should companies pay? It’s not an easy answer, a pair of experts told colleagues in an American Medical Association (AMA) cybersecurity webinar on October 18. It turns out that each choice — pay or don’t pay — can end up being costly.

This is just one of the new challenges facing the American medical system on the cybersecurity front, the speakers said. Others include the possibility that hackers will manipulate patient data — turning a medical test negative, for example, when it’s actually positive — and take advantage of the powers of artificial intelligence (AI).

The AMA held the webinar to educate physicians about cybersecurity risks and defenses, an especially hot topic in the wake of February’s Change Healthcare hack, which cost UnitedHealth Group an estimated $2.5 billion — so far — and deeply disrupted the American healthcare system.

Cautionary tales abound. Greg Garcia, executive director for cybersecurity of the Health Sector Coordinating Council, a coalition of medical industry organizations, pointed to a Pennsylvania clinic that refused to pay a ransom to prevent the release of hundreds of images of patients with breast cancer undressed from the waist up. Garcia told webinar participants that the ransom was $5 million.
 

Risky Choices

While the Federal Bureau of Investigation recommends against paying a ransom, this can be a risky choice, Garcia said. Hackers released the images, and the center has reportedly agreed to settle a class-action lawsuit for $65 million. “They traded $5 million for $60 million,” Garcia added, slightly misstating the settlement amount.

Health systems have been cagey about whether they’ve paid ransoms to prevent private data from being made public in cyberattacks. If a ransom is demanded, “it’s every organization for itself,” Garcia said.

He highlighted the case of a chain of psychiatry practices in Finland that suffered a ransomware attack in 2020. The hackers “contacted the patients and said: ‘Hey, call your clinic and tell them to pay the ransom. Otherwise, we’re going to release all your psychiatric notes to the public.’ ”

Cyberattacks continue. In October, Boston Children’s Health Physicians announced that it had suffered a “ recent security incident” involving data — possibly including Social Security numbers and treatment information — regarding patients and employees. A hacker group reportedly claimed responsibility and wants the system, which boasts more than 300 clinicians, to pay a ransom or else it will release the stolen information.
 

Should Paying Ransom Be a Crime?

Christian Dameff, MD, MS, an emergency medicine physician and director of the Center for Healthcare Cybersecurity at the University of California (UC), San Diego, noted that there are efforts to turn paying ransom into a crime. “If people aren’t paying ransoms, then ransomware operators will move to something else that makes them money.”

Dameff urged colleagues to understand we no longer live in a world where clinicians only bother to think of technology when they call the IT department to help them reset their password.

New challenges face clinicians, he said. “How do we develop better strategies, downtime procedures, and safe clinical care in an era where our vital technology may be gone, not just for an hour or 2, but as is the case with these ransomware attacks, sometimes weeks to months.”

Garcia said “cybersecurity is everybody’s responsibility, including frontline clinicians. Because you’re touching data, you’re touching technology, you’re touching patients, and all of those things combine to present some vulnerabilities in the digital world.”
 

Next Frontier: Hackers May Manipulate Patient Data

Dameff said future hackers may use AI to manipulate individual patient data in ways that threaten patient health. AI makes this easier to accomplish.

“What if I delete your allergies in your electronic health record, or I manipulate your chest x-ray, or I change your lab values so it looks like you’re in diabetic ketoacidosis when you’re not so a clinician gives you insulin when you don’t need it?”

Garcia highlighted another new threat: Phishing efforts that are harder to ignore thanks to AI.

“One of the most successful way that hackers get in, disrupt systems, and steal data is through email phishing, and it’s only going to get better because of artificial intelligence,” he said. “No longer are you going to have typos in that email written by a hacking group in Nigeria or in China. It’s going to be perfect looking.”

What can practices and healthcare systems do? Garcia highlighted federal health agency efforts to encourage organizations to adopt best practices in cybersecurity.

“If you’ve got a data breach, and you can show to the US Department of Health & Human Services [HHS] you have implemented generally recognized cybersecurity controls over the past year, that you have done your best, you did the right thing, and you still got hit, HHS is directed to essentially take it easy on you,” he said. “That’s a positive incentive.”
 

Ransomware Guide in the Works

Dameff said UC San Diego’s Center for Healthcare Cybersecurity plans to publish a free cybersecurity guide in 2025 that will include specific information about ransomware attacks for medical specialties such as cardiology, trauma surgery, and pediatrics.

“Then, should you ever be ransomed, you can pull out this guide. You’ll know what’s going to kind of happen, and you can better prepare for those effects.”

Will the future president prioritize healthcare cybersecurity? That remains to be seen, but crises do have the capacity to concentrate the mind, experts said.

The nation’s capital “has a very short memory, a short attention span. The policymakers tend to be reactive,” Dameff said. “All it takes is yet another Change Healthcare–like attack that disrupts 30% or more of the nation’s healthcare system for the policymakers to sit up, take notice, and try to come up with solutions.”

In addition, he said, an estimated two data breaches/ransomware attacks are occurring per day. “The fact is that we’re all patients, up to the President of the United States and every member of the Congress is a patient.”

There’s a “very existential, very palpable understanding that cyber safety is patient safety and cyber insecurity is patient insecurity,” Dameff said.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity .

Robert A. Harrington, MD: I’m here in London at the European Society of Cardiology meetings, at theheart.org | Medscape Cardiology booth, using the meetings as an opportunity to meet with colleagues to talk about recent things that they’ve been writing about.

Today I’m joined by a good friend and colleague, Dr. Dhruv Kazi from Beth Israel Deaconess in Boston. Thanks for joining us.

Dhruv S. Kazi, MD, MS: Thank you for having me.

Harrington: Dr. Kazi is an associate professor of medicine at Harvard Medical School. He’s also the associate director of the Smith Center, which is an outcomes research center at the Beth Israel Deaconess. Thanks for joining us.

Kazi: Excited to be here.

Harrington: The topic I think you know that I want to discuss is a really important paper. There are two papers. They’re part of the American Heart Association’s 100th anniversary celebration, if you will. Many of the papers looked back at where science taken us.

With your coauthor, Karen Joynt Maddox, your papers are looking forward. They’re about the burden of cardiovascular disease in 2050. One paper really focused on what I would call the clinical and public health issues. Yours is focused on the economics. Is that a good description?

Kazi: Perfect.

Harrington: Tell us what you, Karen, and the other writers set out to do. What were you asked to do?

Kazi: As you know, the American Heart Association is entering its second century. Part of this was an exercise to say, where will the country be in 2050, which is a long enough time horizon for us to start planning for the future. What are the conditions that affect the magnitude of the disease, and the kinds of people who will be affected, that we should be aware of?

We looked back and said, if prior trends remain the same, where will we be in 2050, accounting for changes in demographics, changes in the composition of the population, and knowing that some of the cardiovascular risk factors are getting worse?

Harrington: For me, what was really striking is that, when I first saw the title and read “2050,” I thought, Oh, that’s a long way away. Then as I started reading it, I realized that this is not so far away.

Kazi: Absolutely.

Harrington: If we’re going to make a difference, it might take us 25 years.

Kazi: Especially if we set ourselves ambitious goals, we›re going to have to dig deep. Business-as-usual is not going to get us there.

Harrington: No. What I think has happened is we›ve spent so much time taking care of acute illness. Case fatality rates are fantastic. I was actually making the comment yesterday to a colleague that when I was an intern, the 30-day death rate from acute myocardial infarction was about 20%.

Kazi: Oh, wow.

Harrington: Now it’s 5%. That’s a big difference in a career.
 

Trends in the Wrong Direction

Kazi: There are fundamental trends. The decline in case fatalities is a really positive development, and I would hope that, going forward, that would continue. Those are risk-adjusted death rates and what is happening is that risk is going up. This is a function of the fact that the US population is aging; 2030 will be the first year that all the baby boomers will be over the age of 65.

By the mid-2030s, we’ll have more adults over the age of 65 than kids. That aging of the population is going to increase risk. The second is — and this is a positive development — we are a more diverse population, but the populations that are minoritized have higher cardiovascular risk, for a variety of reasons.

As the population of Asian Americans increases and doubles, in fact, as the population of Hispanic Americans doubles, we’re going to see an increase in risk related to cardiovascular disease. The third is that, over the past decade, there are some risk factors that are going in the wrong direction.

Harrington: Let’s talk about that because that’s humbling. I’m involved, as you know, with the American Heart Association, as are you. Despite all the work on Life’s Simple 7 and now Life’s Essential 8, we still have some issues.

Kazi: The big ones that come to mind are hypertension, diabetes, and obesity, all of which are trending in the wrong direction. Hypertension, we were gaining traction; and then over the past decade, we’ve slipped again. As you know, national blood pressure control rates have declined in many populations.

Harrington: Rather substantially.

Kazi: Substantially so, which has implications, in particular, for stroke rates in the future and stroke rates in young adults in the future. Obesity is a problem that we have very little control over. We’re already at 40% on average, which means that some populations are already in the 60% range.

Harrington: We also have obesity in kids — the burden, I’ll call it, of obesity. It’s not that you become obese in your thirties or your forties; you›re becoming obese as a teenager or even younger.

Kazi: Exactly. Since the 1990s, obesity in US adults has doubled, but obesity in US children has quadrupled. It’s starting from a lower base, but it’s very much an escalating problem.

Harrington: Diabetes is tightly linked to it but not totally explained.

Kazi: Exactly. The increase in diabetes is largely driven by obesity, but it›s probably also driven by changes in diet and lifestyle that don›t go through obesity.

Harrington: Yeah, it’s interesting. I think I have this figure correctly. It used to be rare that you saw a child with type 2 diabetes or what we call type 2 diabetes.

Kazi: Yeah.

Harrington: Now, the vast majority of kids with diabetes have type 2 diabetes.

Kazi: In the adolescents/young adults age group, most of it is type 2.

Harrington: Diabetes going up, obesity up, hypertension not well controlled, smoking combustible cigarettes way down.

Kazi: Yeah.

Harrington: Cholesterol levels. I was surprised. Cholesterol looked better. You said — because I was at a meeting where somebody asked you — that’s not explained by treatment.

Kazi: No, it’s not, at least going back to the ‘70s, but likely even sooner. I think that can only be attributed to substantial dietary changes. We are consuming less fat and less trans-fat. It’s possible that those collectively are improving our cholesterol levels, possibly at the expense of our glucose levels, because we basically substituted fats in our diet with more carbs at a population level.
 

Cigarettes and Vaping

Harrington: Some things certainly trend in the right direction but others in a really difficult direction. It’s going to lead to pretty large changes in risk for coronary disease, atrial fibrillation, and heart failure.

Kazi: I want to go back to the tobacco point. There are definitely marked declines in tobacco, still tightly related to income in the country. You see much higher prevalence of tobacco use in lower-income populations, but it’s unclear to me where it’s going in kids. We know that combustible tobacco use is going down but e-cigarettes went up. What that leads to over the next 30 years is unclear to me.

Harrington: That is a really important comment that’s worth sidebarring. The vaping use has been a terrible epidemic among our high schoolers. What is that going to lead to? Is it going to lead to the use of combustible cigarettes and we’re going to see that go back up? It remains to be seen.

Kazi: Yes, it remains to be seen. Going back to your point about this change in risk factors and this change in demographics, both aging and becoming a more diverse population means that we have large increases in some healthcare conditions.

Coronary heart disease goes up some, there›s a big jump in stroke — nearly a doubling in stroke — which is related to hypertension, obesity, an aging population, and a more diverse population. There are changes in stroke in the young, and atrial fibrillation related to, again, hypertension. We’re seeing these projections, and with them come these pretty large projections in changes in healthcare spending.
 

Healthcare Spending Not Sustainable

Harrington: Big. I mean, it’s not sustainable. Give the audience the number — it’s pretty frightening.

Kazi: We’re talking about a quadrupling of healthcare costs related to cardiovascular disease over 25 years. We’ve gotten used to the narrative that healthcare in the US is expensive and drugs are expensive, but this is an enormous problem — an unsustainable problem, like you called it.

It’s a doubling as a proportion of the economy. I was looking this up this morning. If the US healthcare economy were its own economy, it would be the fourth largest economy in the world.

Harrington: Healthcare as it is today, is it 21% of our economy?

Kazi: It’s 17% now. If it were its own economy, it would be the fourth largest in the world. We are spending more on healthcare than all but two other countries’ total economies. It’s kind of crazy.

Harrington: We’re talking about a quadrupling.

Kazi: Within that, the cardiovascular piece is a big piece, and we›re talking about a quadrupling.

Harrington: That’s both direct and indirect costs.

Kazi: The quadrupling of costs is just the direct costs. Indirect costs, for the listeners, refer to costs unrelated to healthcare but changes in productivity, either because people are disabled and unable to participate fully in the workforce or they die early.

The productivity costs are also increased substantially as a result. If you look at both healthcare and productivity, that goes up threefold. These are very large changes.

Harrington: Let’s now get to what we can do about it. I made the comment to you when I first read the papers that I was very depressed. Then, after I went through my Kübler-Ross stages of depression, death, and dying, I came to acceptance.

What are we going to do about it? This is a focus on policy, but also a focus on how we deliver healthcare, how we think about healthcare, and how we develop drugs and devices.

The drug question is going to be the one the audience is thinking about. They say, well, what about GLP-1 agonists? Aren’t those going to save the day?

Kazi: Yes and no. I’ll say that, early in my career, I used to be very attracted to simple solutions to complex problems. I’ve come to realize that simple solutions are elegant, attractive, and wrong. We›re dealing with a very complex issue and I think we’re going to need a multipronged approach.

The way I think about it is that there was a group of people who are at very high risk today. How do we help those individuals? Then how do we help the future generation so that they’re not dealing with the projections that we’re talking about.

My colleague, Karen Joynt Maddox, who led one of the papers, as you mentioned, has an elegant line in the paper where she says projections are not destiny. These are things we can change.

Harrington: If nothing changes, this is what it’s going to look like.

Kazi: This is where we’re headed.

Harrington: We can change. We’ve got some time to change, but we don’t have forever.

Kazi: Yes, exactly. We picked the 25-year timeline instead of a “let’s plan for the next century” timeline because we want something concrete and actionable. It’s close enough to be meaningful but far enough to give us the runway we need to act.

Harrington: Give me two things from the policy perspective, because it’s mostly policy.

Kazi: There are policy and clinical interventions. From the policy perspective, if I had to list two things, one is expansion of access to care. As we talk about this big increase in the burden of disease and risk factors, if you have a large proportion of your population that has hypertension or diabetes, you’re going to have to expand access to care to ensure that people get treated so they can get access to this care before they develop the complications that we worry about, like stroke and heart disease, that are very expensive to treat downstream.

The second, more broadly related to access to care, is the access to medications that are effective. You bring up GLP-1s. I think we need a real strategy for how we can give people access to GLP-1s at a price that is affordable to individuals but also affordable to the health system, and to help them stay on the drugs.

GLP-1s are transformative in what they do for weight loss and for diabetes, but more than 50% of people who start one are off it at 12 months. There’s something fundamentally wrong about how we’re delivering GLP-1s today. It’s not just about the cost of the drugs but the support system people need to stay on.

Harrington: I’ve made the comment, in many forms now, that we know the drugs work. We have to figure out how to use them.

Kazi: Exactly, yes.

Harrington: Using them includes chronicity. This is a chronic condition. Some people can come off the drugs, but many can’t. We’re going to have to figure this out, and maybe the newer generations of drugs will help us address what people call the off-ramping. How are we going to do that? I think you’re spot-on. Those are critically important questions.

Kazi: As we looked at this modeling, I’ll tell you — I had a come-to-Jesus moment where I was like, there is no way to fix cardiovascular disease in the US without going through obesity and diabetes. We have to address obesity in the US. We can’t just treat our way out of it. Obesity is fundamentally a food problem and we’ve got to engage again with food policy in a meaningful way.

Harrington: As you know, with the American Heart Association, we›re doing a large amount of work now on food as medicine and food is medicine. We are trying to figure out what the levers are that we can pull to actually help people eat healthier diets.

Kazi: Yes. Rather than framing it as an individual choice that people are eating poorly, it’s, how do we make healthy diets the default in the environment?

Harrington: This is where you get to the children as well.

Kazi: Exactly.

Harrington: I could talk about this all day. I’ve had the benefit of reading the papers now a few times and talking to you on several occasions. Thank you for joining us.

Kazi: Thank you.
 

Dr. Harrington, Stephen and Suzanne Weiss Dean, Weill Cornell Medicine; Provost for Medical Affairs, Cornell University, New York, NY, disclosed ties with Baim Institute (DSMB); CSL (RCT Executive Committee); Janssen (RCT Char), NHLBI (RCT Executive Committee, DSMB Chair); PCORI (RCT Co-Chair); DCRI, Atropos Health; Bitterroot Bio; Bristol Myers Squibb; BridgeBio; Element Science; Edwards Lifesciences; Foresite Labs; Medscape/WebMD Board of Directors for: American Heart Association; College of the Holy Cross; and Cytokinetics. Dr. Kazi, Associate Director, Smith Center for Outcomes Research, Associate Professor, Department of Medicine (Cardiology), Harvard Medical School, Director, Department of Cardiac Critical Care Unit, Beth Israel Deaconess Medical Center, Boston, Massachusetts, has disclosed receiving a research grant from Boston Scientific (grant to examine the economics of stroke prevention).

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity .

Robert A. Harrington, MD: I’m here in London at the European Society of Cardiology meetings, at theheart.org | Medscape Cardiology booth, using the meetings as an opportunity to meet with colleagues to talk about recent things that they’ve been writing about.

Today I’m joined by a good friend and colleague, Dr. Dhruv Kazi from Beth Israel Deaconess in Boston. Thanks for joining us.

Dhruv S. Kazi, MD, MS: Thank you for having me.

Harrington: Dr. Kazi is an associate professor of medicine at Harvard Medical School. He’s also the associate director of the Smith Center, which is an outcomes research center at the Beth Israel Deaconess. Thanks for joining us.

Kazi: Excited to be here.

Harrington: The topic I think you know that I want to discuss is a really important paper. There are two papers. They’re part of the American Heart Association’s 100th anniversary celebration, if you will. Many of the papers looked back at where science taken us.

With your coauthor, Karen Joynt Maddox, your papers are looking forward. They’re about the burden of cardiovascular disease in 2050. One paper really focused on what I would call the clinical and public health issues. Yours is focused on the economics. Is that a good description?

Kazi: Perfect.

Harrington: Tell us what you, Karen, and the other writers set out to do. What were you asked to do?

Kazi: As you know, the American Heart Association is entering its second century. Part of this was an exercise to say, where will the country be in 2050, which is a long enough time horizon for us to start planning for the future. What are the conditions that affect the magnitude of the disease, and the kinds of people who will be affected, that we should be aware of?

We looked back and said, if prior trends remain the same, where will we be in 2050, accounting for changes in demographics, changes in the composition of the population, and knowing that some of the cardiovascular risk factors are getting worse?

Harrington: For me, what was really striking is that, when I first saw the title and read “2050,” I thought, Oh, that’s a long way away. Then as I started reading it, I realized that this is not so far away.

Kazi: Absolutely.

Harrington: If we’re going to make a difference, it might take us 25 years.

Kazi: Especially if we set ourselves ambitious goals, we›re going to have to dig deep. Business-as-usual is not going to get us there.

Harrington: No. What I think has happened is we›ve spent so much time taking care of acute illness. Case fatality rates are fantastic. I was actually making the comment yesterday to a colleague that when I was an intern, the 30-day death rate from acute myocardial infarction was about 20%.

Kazi: Oh, wow.

Harrington: Now it’s 5%. That’s a big difference in a career.
 

Trends in the Wrong Direction

Kazi: There are fundamental trends. The decline in case fatalities is a really positive development, and I would hope that, going forward, that would continue. Those are risk-adjusted death rates and what is happening is that risk is going up. This is a function of the fact that the US population is aging; 2030 will be the first year that all the baby boomers will be over the age of 65.

By the mid-2030s, we’ll have more adults over the age of 65 than kids. That aging of the population is going to increase risk. The second is — and this is a positive development — we are a more diverse population, but the populations that are minoritized have higher cardiovascular risk, for a variety of reasons.

As the population of Asian Americans increases and doubles, in fact, as the population of Hispanic Americans doubles, we’re going to see an increase in risk related to cardiovascular disease. The third is that, over the past decade, there are some risk factors that are going in the wrong direction.

Harrington: Let’s talk about that because that’s humbling. I’m involved, as you know, with the American Heart Association, as are you. Despite all the work on Life’s Simple 7 and now Life’s Essential 8, we still have some issues.

Kazi: The big ones that come to mind are hypertension, diabetes, and obesity, all of which are trending in the wrong direction. Hypertension, we were gaining traction; and then over the past decade, we’ve slipped again. As you know, national blood pressure control rates have declined in many populations.

Harrington: Rather substantially.

Kazi: Substantially so, which has implications, in particular, for stroke rates in the future and stroke rates in young adults in the future. Obesity is a problem that we have very little control over. We’re already at 40% on average, which means that some populations are already in the 60% range.

Harrington: We also have obesity in kids — the burden, I’ll call it, of obesity. It’s not that you become obese in your thirties or your forties; you›re becoming obese as a teenager or even younger.

Kazi: Exactly. Since the 1990s, obesity in US adults has doubled, but obesity in US children has quadrupled. It’s starting from a lower base, but it’s very much an escalating problem.

Harrington: Diabetes is tightly linked to it but not totally explained.

Kazi: Exactly. The increase in diabetes is largely driven by obesity, but it›s probably also driven by changes in diet and lifestyle that don›t go through obesity.

Harrington: Yeah, it’s interesting. I think I have this figure correctly. It used to be rare that you saw a child with type 2 diabetes or what we call type 2 diabetes.

Kazi: Yeah.

Harrington: Now, the vast majority of kids with diabetes have type 2 diabetes.

Kazi: In the adolescents/young adults age group, most of it is type 2.

Harrington: Diabetes going up, obesity up, hypertension not well controlled, smoking combustible cigarettes way down.

Kazi: Yeah.

Harrington: Cholesterol levels. I was surprised. Cholesterol looked better. You said — because I was at a meeting where somebody asked you — that’s not explained by treatment.

Kazi: No, it’s not, at least going back to the ‘70s, but likely even sooner. I think that can only be attributed to substantial dietary changes. We are consuming less fat and less trans-fat. It’s possible that those collectively are improving our cholesterol levels, possibly at the expense of our glucose levels, because we basically substituted fats in our diet with more carbs at a population level.
 

Cigarettes and Vaping

Harrington: Some things certainly trend in the right direction but others in a really difficult direction. It’s going to lead to pretty large changes in risk for coronary disease, atrial fibrillation, and heart failure.

Kazi: I want to go back to the tobacco point. There are definitely marked declines in tobacco, still tightly related to income in the country. You see much higher prevalence of tobacco use in lower-income populations, but it’s unclear to me where it’s going in kids. We know that combustible tobacco use is going down but e-cigarettes went up. What that leads to over the next 30 years is unclear to me.

Harrington: That is a really important comment that’s worth sidebarring. The vaping use has been a terrible epidemic among our high schoolers. What is that going to lead to? Is it going to lead to the use of combustible cigarettes and we’re going to see that go back up? It remains to be seen.

Kazi: Yes, it remains to be seen. Going back to your point about this change in risk factors and this change in demographics, both aging and becoming a more diverse population means that we have large increases in some healthcare conditions.

Coronary heart disease goes up some, there›s a big jump in stroke — nearly a doubling in stroke — which is related to hypertension, obesity, an aging population, and a more diverse population. There are changes in stroke in the young, and atrial fibrillation related to, again, hypertension. We’re seeing these projections, and with them come these pretty large projections in changes in healthcare spending.
 

Healthcare Spending Not Sustainable

Harrington: Big. I mean, it’s not sustainable. Give the audience the number — it’s pretty frightening.

Kazi: We’re talking about a quadrupling of healthcare costs related to cardiovascular disease over 25 years. We’ve gotten used to the narrative that healthcare in the US is expensive and drugs are expensive, but this is an enormous problem — an unsustainable problem, like you called it.

It’s a doubling as a proportion of the economy. I was looking this up this morning. If the US healthcare economy were its own economy, it would be the fourth largest economy in the world.

Harrington: Healthcare as it is today, is it 21% of our economy?

Kazi: It’s 17% now. If it were its own economy, it would be the fourth largest in the world. We are spending more on healthcare than all but two other countries’ total economies. It’s kind of crazy.

Harrington: We’re talking about a quadrupling.

Kazi: Within that, the cardiovascular piece is a big piece, and we›re talking about a quadrupling.

Harrington: That’s both direct and indirect costs.

Kazi: The quadrupling of costs is just the direct costs. Indirect costs, for the listeners, refer to costs unrelated to healthcare but changes in productivity, either because people are disabled and unable to participate fully in the workforce or they die early.

The productivity costs are also increased substantially as a result. If you look at both healthcare and productivity, that goes up threefold. These are very large changes.

Harrington: Let’s now get to what we can do about it. I made the comment to you when I first read the papers that I was very depressed. Then, after I went through my Kübler-Ross stages of depression, death, and dying, I came to acceptance.

What are we going to do about it? This is a focus on policy, but also a focus on how we deliver healthcare, how we think about healthcare, and how we develop drugs and devices.

The drug question is going to be the one the audience is thinking about. They say, well, what about GLP-1 agonists? Aren’t those going to save the day?

Kazi: Yes and no. I’ll say that, early in my career, I used to be very attracted to simple solutions to complex problems. I’ve come to realize that simple solutions are elegant, attractive, and wrong. We›re dealing with a very complex issue and I think we’re going to need a multipronged approach.

The way I think about it is that there was a group of people who are at very high risk today. How do we help those individuals? Then how do we help the future generation so that they’re not dealing with the projections that we’re talking about.

My colleague, Karen Joynt Maddox, who led one of the papers, as you mentioned, has an elegant line in the paper where she says projections are not destiny. These are things we can change.

Harrington: If nothing changes, this is what it’s going to look like.

Kazi: This is where we’re headed.

Harrington: We can change. We’ve got some time to change, but we don’t have forever.

Kazi: Yes, exactly. We picked the 25-year timeline instead of a “let’s plan for the next century” timeline because we want something concrete and actionable. It’s close enough to be meaningful but far enough to give us the runway we need to act.

Harrington: Give me two things from the policy perspective, because it’s mostly policy.

Kazi: There are policy and clinical interventions. From the policy perspective, if I had to list two things, one is expansion of access to care. As we talk about this big increase in the burden of disease and risk factors, if you have a large proportion of your population that has hypertension or diabetes, you’re going to have to expand access to care to ensure that people get treated so they can get access to this care before they develop the complications that we worry about, like stroke and heart disease, that are very expensive to treat downstream.

The second, more broadly related to access to care, is the access to medications that are effective. You bring up GLP-1s. I think we need a real strategy for how we can give people access to GLP-1s at a price that is affordable to individuals but also affordable to the health system, and to help them stay on the drugs.

GLP-1s are transformative in what they do for weight loss and for diabetes, but more than 50% of people who start one are off it at 12 months. There’s something fundamentally wrong about how we’re delivering GLP-1s today. It’s not just about the cost of the drugs but the support system people need to stay on.

Harrington: I’ve made the comment, in many forms now, that we know the drugs work. We have to figure out how to use them.

Kazi: Exactly, yes.

Harrington: Using them includes chronicity. This is a chronic condition. Some people can come off the drugs, but many can’t. We’re going to have to figure this out, and maybe the newer generations of drugs will help us address what people call the off-ramping. How are we going to do that? I think you’re spot-on. Those are critically important questions.

Kazi: As we looked at this modeling, I’ll tell you — I had a come-to-Jesus moment where I was like, there is no way to fix cardiovascular disease in the US without going through obesity and diabetes. We have to address obesity in the US. We can’t just treat our way out of it. Obesity is fundamentally a food problem and we’ve got to engage again with food policy in a meaningful way.

Harrington: As you know, with the American Heart Association, we›re doing a large amount of work now on food as medicine and food is medicine. We are trying to figure out what the levers are that we can pull to actually help people eat healthier diets.

Kazi: Yes. Rather than framing it as an individual choice that people are eating poorly, it’s, how do we make healthy diets the default in the environment?

Harrington: This is where you get to the children as well.

Kazi: Exactly.

Harrington: I could talk about this all day. I’ve had the benefit of reading the papers now a few times and talking to you on several occasions. Thank you for joining us.

Kazi: Thank you.
 

Dr. Harrington, Stephen and Suzanne Weiss Dean, Weill Cornell Medicine; Provost for Medical Affairs, Cornell University, New York, NY, disclosed ties with Baim Institute (DSMB); CSL (RCT Executive Committee); Janssen (RCT Char), NHLBI (RCT Executive Committee, DSMB Chair); PCORI (RCT Co-Chair); DCRI, Atropos Health; Bitterroot Bio; Bristol Myers Squibb; BridgeBio; Element Science; Edwards Lifesciences; Foresite Labs; Medscape/WebMD Board of Directors for: American Heart Association; College of the Holy Cross; and Cytokinetics. Dr. Kazi, Associate Director, Smith Center for Outcomes Research, Associate Professor, Department of Medicine (Cardiology), Harvard Medical School, Director, Department of Cardiac Critical Care Unit, Beth Israel Deaconess Medical Center, Boston, Massachusetts, has disclosed receiving a research grant from Boston Scientific (grant to examine the economics of stroke prevention).

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity .

Robert A. Harrington, MD: I’m here in London at the European Society of Cardiology meetings, at theheart.org | Medscape Cardiology booth, using the meetings as an opportunity to meet with colleagues to talk about recent things that they’ve been writing about.

Today I’m joined by a good friend and colleague, Dr. Dhruv Kazi from Beth Israel Deaconess in Boston. Thanks for joining us.

Dhruv S. Kazi, MD, MS: Thank you for having me.

Harrington: Dr. Kazi is an associate professor of medicine at Harvard Medical School. He’s also the associate director of the Smith Center, which is an outcomes research center at the Beth Israel Deaconess. Thanks for joining us.

Kazi: Excited to be here.

Harrington: The topic I think you know that I want to discuss is a really important paper. There are two papers. They’re part of the American Heart Association’s 100th anniversary celebration, if you will. Many of the papers looked back at where science taken us.

With your coauthor, Karen Joynt Maddox, your papers are looking forward. They’re about the burden of cardiovascular disease in 2050. One paper really focused on what I would call the clinical and public health issues. Yours is focused on the economics. Is that a good description?

Kazi: Perfect.

Harrington: Tell us what you, Karen, and the other writers set out to do. What were you asked to do?

Kazi: As you know, the American Heart Association is entering its second century. Part of this was an exercise to say, where will the country be in 2050, which is a long enough time horizon for us to start planning for the future. What are the conditions that affect the magnitude of the disease, and the kinds of people who will be affected, that we should be aware of?

We looked back and said, if prior trends remain the same, where will we be in 2050, accounting for changes in demographics, changes in the composition of the population, and knowing that some of the cardiovascular risk factors are getting worse?

Harrington: For me, what was really striking is that, when I first saw the title and read “2050,” I thought, Oh, that’s a long way away. Then as I started reading it, I realized that this is not so far away.

Kazi: Absolutely.

Harrington: If we’re going to make a difference, it might take us 25 years.

Kazi: Especially if we set ourselves ambitious goals, we›re going to have to dig deep. Business-as-usual is not going to get us there.

Harrington: No. What I think has happened is we›ve spent so much time taking care of acute illness. Case fatality rates are fantastic. I was actually making the comment yesterday to a colleague that when I was an intern, the 30-day death rate from acute myocardial infarction was about 20%.

Kazi: Oh, wow.

Harrington: Now it’s 5%. That’s a big difference in a career.
 

Trends in the Wrong Direction

Kazi: There are fundamental trends. The decline in case fatalities is a really positive development, and I would hope that, going forward, that would continue. Those are risk-adjusted death rates and what is happening is that risk is going up. This is a function of the fact that the US population is aging; 2030 will be the first year that all the baby boomers will be over the age of 65.

By the mid-2030s, we’ll have more adults over the age of 65 than kids. That aging of the population is going to increase risk. The second is — and this is a positive development — we are a more diverse population, but the populations that are minoritized have higher cardiovascular risk, for a variety of reasons.

As the population of Asian Americans increases and doubles, in fact, as the population of Hispanic Americans doubles, we’re going to see an increase in risk related to cardiovascular disease. The third is that, over the past decade, there are some risk factors that are going in the wrong direction.

Harrington: Let’s talk about that because that’s humbling. I’m involved, as you know, with the American Heart Association, as are you. Despite all the work on Life’s Simple 7 and now Life’s Essential 8, we still have some issues.

Kazi: The big ones that come to mind are hypertension, diabetes, and obesity, all of which are trending in the wrong direction. Hypertension, we were gaining traction; and then over the past decade, we’ve slipped again. As you know, national blood pressure control rates have declined in many populations.

Harrington: Rather substantially.

Kazi: Substantially so, which has implications, in particular, for stroke rates in the future and stroke rates in young adults in the future. Obesity is a problem that we have very little control over. We’re already at 40% on average, which means that some populations are already in the 60% range.

Harrington: We also have obesity in kids — the burden, I’ll call it, of obesity. It’s not that you become obese in your thirties or your forties; you›re becoming obese as a teenager or even younger.

Kazi: Exactly. Since the 1990s, obesity in US adults has doubled, but obesity in US children has quadrupled. It’s starting from a lower base, but it’s very much an escalating problem.

Harrington: Diabetes is tightly linked to it but not totally explained.

Kazi: Exactly. The increase in diabetes is largely driven by obesity, but it›s probably also driven by changes in diet and lifestyle that don›t go through obesity.

Harrington: Yeah, it’s interesting. I think I have this figure correctly. It used to be rare that you saw a child with type 2 diabetes or what we call type 2 diabetes.

Kazi: Yeah.

Harrington: Now, the vast majority of kids with diabetes have type 2 diabetes.

Kazi: In the adolescents/young adults age group, most of it is type 2.

Harrington: Diabetes going up, obesity up, hypertension not well controlled, smoking combustible cigarettes way down.

Kazi: Yeah.

Harrington: Cholesterol levels. I was surprised. Cholesterol looked better. You said — because I was at a meeting where somebody asked you — that’s not explained by treatment.

Kazi: No, it’s not, at least going back to the ‘70s, but likely even sooner. I think that can only be attributed to substantial dietary changes. We are consuming less fat and less trans-fat. It’s possible that those collectively are improving our cholesterol levels, possibly at the expense of our glucose levels, because we basically substituted fats in our diet with more carbs at a population level.
 

Cigarettes and Vaping

Harrington: Some things certainly trend in the right direction but others in a really difficult direction. It’s going to lead to pretty large changes in risk for coronary disease, atrial fibrillation, and heart failure.

Kazi: I want to go back to the tobacco point. There are definitely marked declines in tobacco, still tightly related to income in the country. You see much higher prevalence of tobacco use in lower-income populations, but it’s unclear to me where it’s going in kids. We know that combustible tobacco use is going down but e-cigarettes went up. What that leads to over the next 30 years is unclear to me.

Harrington: That is a really important comment that’s worth sidebarring. The vaping use has been a terrible epidemic among our high schoolers. What is that going to lead to? Is it going to lead to the use of combustible cigarettes and we’re going to see that go back up? It remains to be seen.

Kazi: Yes, it remains to be seen. Going back to your point about this change in risk factors and this change in demographics, both aging and becoming a more diverse population means that we have large increases in some healthcare conditions.

Coronary heart disease goes up some, there›s a big jump in stroke — nearly a doubling in stroke — which is related to hypertension, obesity, an aging population, and a more diverse population. There are changes in stroke in the young, and atrial fibrillation related to, again, hypertension. We’re seeing these projections, and with them come these pretty large projections in changes in healthcare spending.
 

Healthcare Spending Not Sustainable

Harrington: Big. I mean, it’s not sustainable. Give the audience the number — it’s pretty frightening.

Kazi: We’re talking about a quadrupling of healthcare costs related to cardiovascular disease over 25 years. We’ve gotten used to the narrative that healthcare in the US is expensive and drugs are expensive, but this is an enormous problem — an unsustainable problem, like you called it.

It’s a doubling as a proportion of the economy. I was looking this up this morning. If the US healthcare economy were its own economy, it would be the fourth largest economy in the world.

Harrington: Healthcare as it is today, is it 21% of our economy?

Kazi: It’s 17% now. If it were its own economy, it would be the fourth largest in the world. We are spending more on healthcare than all but two other countries’ total economies. It’s kind of crazy.

Harrington: We’re talking about a quadrupling.

Kazi: Within that, the cardiovascular piece is a big piece, and we›re talking about a quadrupling.

Harrington: That’s both direct and indirect costs.

Kazi: The quadrupling of costs is just the direct costs. Indirect costs, for the listeners, refer to costs unrelated to healthcare but changes in productivity, either because people are disabled and unable to participate fully in the workforce or they die early.

The productivity costs are also increased substantially as a result. If you look at both healthcare and productivity, that goes up threefold. These are very large changes.

Harrington: Let’s now get to what we can do about it. I made the comment to you when I first read the papers that I was very depressed. Then, after I went through my Kübler-Ross stages of depression, death, and dying, I came to acceptance.

What are we going to do about it? This is a focus on policy, but also a focus on how we deliver healthcare, how we think about healthcare, and how we develop drugs and devices.

The drug question is going to be the one the audience is thinking about. They say, well, what about GLP-1 agonists? Aren’t those going to save the day?

Kazi: Yes and no. I’ll say that, early in my career, I used to be very attracted to simple solutions to complex problems. I’ve come to realize that simple solutions are elegant, attractive, and wrong. We›re dealing with a very complex issue and I think we’re going to need a multipronged approach.

The way I think about it is that there was a group of people who are at very high risk today. How do we help those individuals? Then how do we help the future generation so that they’re not dealing with the projections that we’re talking about.

My colleague, Karen Joynt Maddox, who led one of the papers, as you mentioned, has an elegant line in the paper where she says projections are not destiny. These are things we can change.

Harrington: If nothing changes, this is what it’s going to look like.

Kazi: This is where we’re headed.

Harrington: We can change. We’ve got some time to change, but we don’t have forever.

Kazi: Yes, exactly. We picked the 25-year timeline instead of a “let’s plan for the next century” timeline because we want something concrete and actionable. It’s close enough to be meaningful but far enough to give us the runway we need to act.

Harrington: Give me two things from the policy perspective, because it’s mostly policy.

Kazi: There are policy and clinical interventions. From the policy perspective, if I had to list two things, one is expansion of access to care. As we talk about this big increase in the burden of disease and risk factors, if you have a large proportion of your population that has hypertension or diabetes, you’re going to have to expand access to care to ensure that people get treated so they can get access to this care before they develop the complications that we worry about, like stroke and heart disease, that are very expensive to treat downstream.

The second, more broadly related to access to care, is the access to medications that are effective. You bring up GLP-1s. I think we need a real strategy for how we can give people access to GLP-1s at a price that is affordable to individuals but also affordable to the health system, and to help them stay on the drugs.

GLP-1s are transformative in what they do for weight loss and for diabetes, but more than 50% of people who start one are off it at 12 months. There’s something fundamentally wrong about how we’re delivering GLP-1s today. It’s not just about the cost of the drugs but the support system people need to stay on.

Harrington: I’ve made the comment, in many forms now, that we know the drugs work. We have to figure out how to use them.

Kazi: Exactly, yes.

Harrington: Using them includes chronicity. This is a chronic condition. Some people can come off the drugs, but many can’t. We’re going to have to figure this out, and maybe the newer generations of drugs will help us address what people call the off-ramping. How are we going to do that? I think you’re spot-on. Those are critically important questions.

Kazi: As we looked at this modeling, I’ll tell you — I had a come-to-Jesus moment where I was like, there is no way to fix cardiovascular disease in the US without going through obesity and diabetes. We have to address obesity in the US. We can’t just treat our way out of it. Obesity is fundamentally a food problem and we’ve got to engage again with food policy in a meaningful way.

Harrington: As you know, with the American Heart Association, we›re doing a large amount of work now on food as medicine and food is medicine. We are trying to figure out what the levers are that we can pull to actually help people eat healthier diets.

Kazi: Yes. Rather than framing it as an individual choice that people are eating poorly, it’s, how do we make healthy diets the default in the environment?

Harrington: This is where you get to the children as well.

Kazi: Exactly.

Harrington: I could talk about this all day. I’ve had the benefit of reading the papers now a few times and talking to you on several occasions. Thank you for joining us.

Kazi: Thank you.
 

Dr. Harrington, Stephen and Suzanne Weiss Dean, Weill Cornell Medicine; Provost for Medical Affairs, Cornell University, New York, NY, disclosed ties with Baim Institute (DSMB); CSL (RCT Executive Committee); Janssen (RCT Char), NHLBI (RCT Executive Committee, DSMB Chair); PCORI (RCT Co-Chair); DCRI, Atropos Health; Bitterroot Bio; Bristol Myers Squibb; BridgeBio; Element Science; Edwards Lifesciences; Foresite Labs; Medscape/WebMD Board of Directors for: American Heart Association; College of the Holy Cross; and Cytokinetics. Dr. Kazi, Associate Director, Smith Center for Outcomes Research, Associate Professor, Department of Medicine (Cardiology), Harvard Medical School, Director, Department of Cardiac Critical Care Unit, Beth Israel Deaconess Medical Center, Boston, Massachusetts, has disclosed receiving a research grant from Boston Scientific (grant to examine the economics of stroke prevention).

A version of this article appeared on Medscape.com.

TOPLINE:

Stroke rates in Californians with sickle cell disease (SCD) have increased in both children and adults in the post-STOP era. The cumulative incidence of first ischemic stroke was 2.1% by age 20 and 13.5% by age 60.

METHODOLOGY:

• Researchers analyzed data from the California Department of Health Care Access and Innovation (HCAI), covering emergency department and hospitalization records from 1991 to 2019.
• A total of 7636 patients with SCD were included in the study cohort.
• Cumulative incidence and rates for primary and recurrent strokes and transient ischemic attacks (TIAs) were determined pre- and post STOP trial.
• Patients with SCD were identified using ICD-9 and ICD-10 codes, with specific criteria for inclusion based on hospitalization records.
• The study utilized Fine and Gray methodology to calculate cumulative incidence functions, accounting for the competing risk for death.

TAKEAWAY:

• The cumulative incidence of first ischemic stroke in patients with SCD was 2.1% by age 20 and 13.5% by age 60.
• Ischemic stroke rates increased significantly in children and adults in the 2010-2019 period, compared with the preceding decade.
• Risk factors for stroke and TIA included increasing age, hypertension, and hyperlipidemia.
• The study found a significant increase in rates of intracranial hemorrhage in adults aged 18-30 years and TIAs in children younger than 18 years from 2010 to 2019, compared with the prior decade.

IN PRACTICE:

“Neurovascular complications, including strokes and transient ischemic attacks (TIAs), are common and cause significant morbidity in individuals with sickle cell disease (SCD). The STOP trial (1998) established chronic transfusions as the standard of care for children with SCD at high risk for stroke,” the study’s authors wrote.

SOURCE:

This study was led by Olubusola B. Oluwole, MD, MS, University of Pittsburgh in Pennsylvania, and was published online in Blood.

LIMITATIONS:

This study’s reliance on administrative data may have introduced systematic errors, particularly with the transition from ICD-9 to ICD-10 codes. The lack of laboratory results and medication data in the HCAI database limited the ability to fully assess patient conditions and treatments. Additionally, the methodology changes in 2014 likely underreported death rates in people without PDD/EDU encounters in the calendar year preceding their death.

DISCLOSURES:

The authors reported no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Stroke rates in Californians with sickle cell disease (SCD) have increased in both children and adults in the post-STOP era. The cumulative incidence of first ischemic stroke was 2.1% by age 20 and 13.5% by age 60.

METHODOLOGY:

• Researchers analyzed data from the California Department of Health Care Access and Innovation (HCAI), covering emergency department and hospitalization records from 1991 to 2019.
• A total of 7636 patients with SCD were included in the study cohort.
• Cumulative incidence and rates for primary and recurrent strokes and transient ischemic attacks (TIAs) were determined pre- and post STOP trial.
• Patients with SCD were identified using ICD-9 and ICD-10 codes, with specific criteria for inclusion based on hospitalization records.
• The study utilized Fine and Gray methodology to calculate cumulative incidence functions, accounting for the competing risk for death.

TAKEAWAY:

• The cumulative incidence of first ischemic stroke in patients with SCD was 2.1% by age 20 and 13.5% by age 60.
• Ischemic stroke rates increased significantly in children and adults in the 2010-2019 period, compared with the preceding decade.
• Risk factors for stroke and TIA included increasing age, hypertension, and hyperlipidemia.
• The study found a significant increase in rates of intracranial hemorrhage in adults aged 18-30 years and TIAs in children younger than 18 years from 2010 to 2019, compared with the prior decade.

IN PRACTICE:

“Neurovascular complications, including strokes and transient ischemic attacks (TIAs), are common and cause significant morbidity in individuals with sickle cell disease (SCD). The STOP trial (1998) established chronic transfusions as the standard of care for children with SCD at high risk for stroke,” the study’s authors wrote.

SOURCE:

This study was led by Olubusola B. Oluwole, MD, MS, University of Pittsburgh in Pennsylvania, and was published online in Blood.

LIMITATIONS:

This study’s reliance on administrative data may have introduced systematic errors, particularly with the transition from ICD-9 to ICD-10 codes. The lack of laboratory results and medication data in the HCAI database limited the ability to fully assess patient conditions and treatments. Additionally, the methodology changes in 2014 likely underreported death rates in people without PDD/EDU encounters in the calendar year preceding their death.

DISCLOSURES:

The authors reported no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Stroke rates in Californians with sickle cell disease (SCD) have increased in both children and adults in the post-STOP era. The cumulative incidence of first ischemic stroke was 2.1% by age 20 and 13.5% by age 60.

METHODOLOGY:

• Researchers analyzed data from the California Department of Health Care Access and Innovation (HCAI), covering emergency department and hospitalization records from 1991 to 2019.
• A total of 7636 patients with SCD were included in the study cohort.
• Cumulative incidence and rates for primary and recurrent strokes and transient ischemic attacks (TIAs) were determined pre- and post STOP trial.
• Patients with SCD were identified using ICD-9 and ICD-10 codes, with specific criteria for inclusion based on hospitalization records.
• The study utilized Fine and Gray methodology to calculate cumulative incidence functions, accounting for the competing risk for death.

TAKEAWAY:

• The cumulative incidence of first ischemic stroke in patients with SCD was 2.1% by age 20 and 13.5% by age 60.
• Ischemic stroke rates increased significantly in children and adults in the 2010-2019 period, compared with the preceding decade.
• Risk factors for stroke and TIA included increasing age, hypertension, and hyperlipidemia.
• The study found a significant increase in rates of intracranial hemorrhage in adults aged 18-30 years and TIAs in children younger than 18 years from 2010 to 2019, compared with the prior decade.

IN PRACTICE:

“Neurovascular complications, including strokes and transient ischemic attacks (TIAs), are common and cause significant morbidity in individuals with sickle cell disease (SCD). The STOP trial (1998) established chronic transfusions as the standard of care for children with SCD at high risk for stroke,” the study’s authors wrote.

SOURCE:

This study was led by Olubusola B. Oluwole, MD, MS, University of Pittsburgh in Pennsylvania, and was published online in Blood.

LIMITATIONS:

This study’s reliance on administrative data may have introduced systematic errors, particularly with the transition from ICD-9 to ICD-10 codes. The lack of laboratory results and medication data in the HCAI database limited the ability to fully assess patient conditions and treatments. Additionally, the methodology changes in 2014 likely underreported death rates in people without PDD/EDU encounters in the calendar year preceding their death.

DISCLOSURES:

The authors reported no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.