Researchers suggest that revising the threshold for high CV risk from 7.5% at 10 years to 10% at 10 years. Also today, psoriasis adds to risk of CV procedures and surgery in hypertension, sickle cell disease gene therapy seen advancing, and early appendectomy is linked with a reduction in risk for developing Parkinson’s later in life.

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Researchers suggest that revising the threshold for high CV risk from 7.5% at 10 years to 10% at 10 years. Also today, psoriasis adds to risk of CV procedures and surgery in hypertension, sickle cell disease gene therapy seen advancing, and early appendectomy is linked with a reduction in risk for developing Parkinson’s later in life.

Amazon Alexa
Apple Podcasts
Spotify

Researchers suggest that revising the threshold for high CV risk from 7.5% at 10 years to 10% at 10 years. Also today, psoriasis adds to risk of CV procedures and surgery in hypertension, sickle cell disease gene therapy seen advancing, and early appendectomy is linked with a reduction in risk for developing Parkinson’s later in life.

Amazon Alexa
Apple Podcasts
Spotify

Click here to access Harm Reduction in Diabetes and Cardiology Care

Table of Contents

• Research News
• Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA_1c Goals
• Predictors of HbA1c Goal Attainment in Patients Treated With Insulin at a VA Pharmacist-Managed Insulin Clinic
• Heart Failure in Older Adults: A Geriatrician Call for Action
• Limited Use of Outpatient Stress Testing in Young Patients With Atypical Chest Pain
• Open Clinical Trials for Diabetes Mellitus Harm Reduction

Click here to access Harm Reduction in Diabetes and Cardiology Care

Table of Contents

• Research News
• Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA_1c Goals
• Predictors of HbA1c Goal Attainment in Patients Treated With Insulin at a VA Pharmacist-Managed Insulin Clinic
• Heart Failure in Older Adults: A Geriatrician Call for Action
• Limited Use of Outpatient Stress Testing in Young Patients With Atypical Chest Pain
• Open Clinical Trials for Diabetes Mellitus Harm Reduction

Click here to access Harm Reduction in Diabetes and Cardiology Care

Table of Contents

• Research News
• Hypoglycemia Safety Initiative: Working With PACT Clinical Pharmacy Specialists to Individualize HbA_1c Goals
• Predictors of HbA1c Goal Attainment in Patients Treated With Insulin at a VA Pharmacist-Managed Insulin Clinic
• Heart Failure in Older Adults: A Geriatrician Call for Action
• Limited Use of Outpatient Stress Testing in Young Patients With Atypical Chest Pain
• Open Clinical Trials for Diabetes Mellitus Harm Reduction

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

People living with HIV who inject drugs often encounter multiple obstacles, both personal and system related, to beginning and adhering to treatment. But NIH researchers found that an “integrated and flexible intervention” not only helped patients overcome those barriers, but also cut deaths by 50%.

The study, HPTN 074, took place in Indonesia, Ukraine, and Vietnam—3 countries with HIV epidemics driven by injection drug use. Researchers enrolled 502 adults with HIV who inject drugs, and 806 adults without HIV, who inject drugs with them (their injection partners). At ≥ 1 injection partner of every person in the study enrolled. The HIV participants were assigned either the national standard of care for HIV infection and drug use, or the standard of care plus the intervention designed to facilitate treatment. The participants were followed for 1 to 2 years.

In the intervention group, participants were referred to local health care providers for anti-HIV therapy. They were also each assigned a systems navigator, who helped the patient identify and overcome structural barriers to starting and staying in care, such as unfamiliarity with how to enroll in medical care, or difficulty keeping appointments. Psychosocial counselors helped each participant overcome their unique psychological obstacles, such as lack of interest in therapy or fear of stigma.

At the end of the study, 15% of participants with HIV who received standard care had died, compared with 7% of the intervention patients. About 26% of deaths among HIV participants were “clearly” HIV related; 3% were due to drug overdose. Among the 42% of patients who died of unknown cause, 24% had weak immune systems.

The intervention had a “remarkably positive impact” on the participants, said Protocol Chair William Miller, MD, PhD. After 1 year, 41% of the intervention group had undetectable levels of HIV, compared with 24% of the standard-care group. Moreover, 72% of the intervention group were still in treatment, compared with 43% of the standard-care group. Similarly, 41% of intervention patients were in treatment for substance use, compared with 25% of standard-care patients.

The study is designed to be scalable to other settings. Investigators have offered the intervention to all the study participants living with HIV. They will be followed for a second year to find out whether the positive impact is sustained.

Source:

National Institutes of Health.  Novel intervention halves rate of death among people living with HIV who inject drugs. https://www.nih.gov/news-events/news-releases/novel-intervention-halves-rate-death-among-people-living-hiv-who-inject-drugs. Published August 31,2018. Accessed October 25, 2018.

BERLIN—Research supports the previously observed association of periventricular lesions with cortical thinning in relapsing-remitting multiple sclerosis (MS) and extends this association to clinically isolated syndrome (CIS) and primary progressive MS, according to results presented at ECTRIMS 2018. “Beyond supporting the role of CSF-related factors for disease-related damage, a periventricular lesion MS phenotype associated with reduced cortical thickness might have the potential to be explored regarding response to different disease-modifying treatments,” said Lukas Pirpamer, a doctoral student at Graz University of Technology in Austria.

Neurologists previously had hypothesized that subpial cortical pathology in MS partly results from CSF factors. In an earlier single-center study, Mr. Pirpamer and colleagues investigated whether tissue changes in intracerebral areas close to CSF were related to cortical pathology. They found that the percentage of periventricular lesion occupancy was correlated with cortical thinning in relapsing-remitting MS, but not in CIS. To corroborate these findings and examine other forms of MS, Mr. Pirpamer and colleagues conducted a multicenter study of the MRI in MS (MAGNIMS) study group, which included patients with primary progressive MS and those with secondary progressive MS.

BERLIN—Research supports the previously observed association of periventricular lesions with cortical thinning in relapsing-remitting multiple sclerosis (MS) and extends this association to clinically isolated syndrome (CIS) and primary progressive MS, according to results presented at ECTRIMS 2018. “Beyond supporting the role of CSF-related factors for disease-related damage, a periventricular lesion MS phenotype associated with reduced cortical thickness might have the potential to be explored regarding response to different disease-modifying treatments,” said Lukas Pirpamer, a doctoral student at Graz University of Technology in Austria.

Neurologists previously had hypothesized that subpial cortical pathology in MS partly results from CSF factors. In an earlier single-center study, Mr. Pirpamer and colleagues investigated whether tissue changes in intracerebral areas close to CSF were related to cortical pathology. They found that the percentage of periventricular lesion occupancy was correlated with cortical thinning in relapsing-remitting MS, but not in CIS. To corroborate these findings and examine other forms of MS, Mr. Pirpamer and colleagues conducted a multicenter study of the MRI in MS (MAGNIMS) study group, which included patients with primary progressive MS and those with secondary progressive MS.

BERLIN—Research supports the previously observed association of periventricular lesions with cortical thinning in relapsing-remitting multiple sclerosis (MS) and extends this association to clinically isolated syndrome (CIS) and primary progressive MS, according to results presented at ECTRIMS 2018. “Beyond supporting the role of CSF-related factors for disease-related damage, a periventricular lesion MS phenotype associated with reduced cortical thickness might have the potential to be explored regarding response to different disease-modifying treatments,” said Lukas Pirpamer, a doctoral student at Graz University of Technology in Austria.

Neurologists previously had hypothesized that subpial cortical pathology in MS partly results from CSF factors. In an earlier single-center study, Mr. Pirpamer and colleagues investigated whether tissue changes in intracerebral areas close to CSF were related to cortical pathology. They found that the percentage of periventricular lesion occupancy was correlated with cortical thinning in relapsing-remitting MS, but not in CIS. To corroborate these findings and examine other forms of MS, Mr. Pirpamer and colleagues conducted a multicenter study of the MRI in MS (MAGNIMS) study group, which included patients with primary progressive MS and those with secondary progressive MS.

Photo by Daniel Sone

Health Canada has granted conditional approval for pralatrexate (Folotyn®) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL).

Pralatrexate received a Notice of Compliance with Conditions (NOC/c), which is an approval granted on the basis of promising evidence of clinical effectiveness that must be verified in additional clinical trials.

To be approved under Health Canada’s NOC/c policy, a product must be intended for the treatment, prevention, or diagnosis of a serious, life-threatening, or severely debilitating illness.

In addition, the product must have demonstrated promising benefit, be of high quality, have an acceptable safety profile based on a benefit/risk assessment, and either respond to a serious unmet need or provide a significant improvement over existing therapies.

The NOC/c for pralatrexate is based on response rates in the single-arm, phase 2 PROPEL trial. Results from PROPEL were published in the Journal of Clinical Oncology in 2011.

The trial enrolled 115 patients with relapsed or refractory PTCL who had received a median of three (range, 1-12) prior systemic therapies.

The patients received pralatrexate once weekly at a dose of 30 mg/m² for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity.

In the 109 evaluable patients, the response rate was 29% (32/109). The complete response rate was 11% (n=12), and the partial response rate was 18% (n=20).

The median duration of response was 10.1 months, the median progression-free survival was 3.5 months, and the median overall survival was 14.5 months.

The most common adverse events (AEs) were mucositis (71%), thrombocytopenia (41%), nausea (41%), fatigue (36%), pyrexia (34%), anemia (34%), constipation (34%), edema (31%), cough (29%), epistaxis (26%), vomiting (25%), neutropenia (25%), and diarrhea (23%).

The most common grade 3/4 AEs were thrombocytopenia (32%), mucositis (22%), neutropenia (22%), and anemia (18%).

The product monograph for pralatrexate contains a boxed warning highlighting the risk of AEs associated with pralatrexate use, including dermatologic reactions, bone marrow suppression, infection, mucosal inflammation, tumor lysis syndrome, potential fetal harm, and pulmonary toxicity.

The product monograph is available for download from the website of Servier Canada, the company marketing pralatrexate in Canada.

Photo by Daniel Sone

Health Canada has granted conditional approval for pralatrexate (Folotyn®) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL).

Pralatrexate received a Notice of Compliance with Conditions (NOC/c), which is an approval granted on the basis of promising evidence of clinical effectiveness that must be verified in additional clinical trials.

To be approved under Health Canada’s NOC/c policy, a product must be intended for the treatment, prevention, or diagnosis of a serious, life-threatening, or severely debilitating illness.

In addition, the product must have demonstrated promising benefit, be of high quality, have an acceptable safety profile based on a benefit/risk assessment, and either respond to a serious unmet need or provide a significant improvement over existing therapies.

The NOC/c for pralatrexate is based on response rates in the single-arm, phase 2 PROPEL trial. Results from PROPEL were published in the Journal of Clinical Oncology in 2011.

The trial enrolled 115 patients with relapsed or refractory PTCL who had received a median of three (range, 1-12) prior systemic therapies.

The patients received pralatrexate once weekly at a dose of 30 mg/m² for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity.

In the 109 evaluable patients, the response rate was 29% (32/109). The complete response rate was 11% (n=12), and the partial response rate was 18% (n=20).

The median duration of response was 10.1 months, the median progression-free survival was 3.5 months, and the median overall survival was 14.5 months.

The most common adverse events (AEs) were mucositis (71%), thrombocytopenia (41%), nausea (41%), fatigue (36%), pyrexia (34%), anemia (34%), constipation (34%), edema (31%), cough (29%), epistaxis (26%), vomiting (25%), neutropenia (25%), and diarrhea (23%).

The most common grade 3/4 AEs were thrombocytopenia (32%), mucositis (22%), neutropenia (22%), and anemia (18%).

The product monograph for pralatrexate contains a boxed warning highlighting the risk of AEs associated with pralatrexate use, including dermatologic reactions, bone marrow suppression, infection, mucosal inflammation, tumor lysis syndrome, potential fetal harm, and pulmonary toxicity.

The product monograph is available for download from the website of Servier Canada, the company marketing pralatrexate in Canada.

Photo by Daniel Sone

Health Canada has granted conditional approval for pralatrexate (Folotyn®) to treat relapsed or refractory peripheral T-cell lymphoma (PTCL).

Pralatrexate received a Notice of Compliance with Conditions (NOC/c), which is an approval granted on the basis of promising evidence of clinical effectiveness that must be verified in additional clinical trials.

To be approved under Health Canada’s NOC/c policy, a product must be intended for the treatment, prevention, or diagnosis of a serious, life-threatening, or severely debilitating illness.

In addition, the product must have demonstrated promising benefit, be of high quality, have an acceptable safety profile based on a benefit/risk assessment, and either respond to a serious unmet need or provide a significant improvement over existing therapies.

The NOC/c for pralatrexate is based on response rates in the single-arm, phase 2 PROPEL trial. Results from PROPEL were published in the Journal of Clinical Oncology in 2011.

The trial enrolled 115 patients with relapsed or refractory PTCL who had received a median of three (range, 1-12) prior systemic therapies.

The patients received pralatrexate once weekly at a dose of 30 mg/m² for 6 weeks in 7-week cycles until disease progression or unacceptable toxicity.

In the 109 evaluable patients, the response rate was 29% (32/109). The complete response rate was 11% (n=12), and the partial response rate was 18% (n=20).

The median duration of response was 10.1 months, the median progression-free survival was 3.5 months, and the median overall survival was 14.5 months.

The most common adverse events (AEs) were mucositis (71%), thrombocytopenia (41%), nausea (41%), fatigue (36%), pyrexia (34%), anemia (34%), constipation (34%), edema (31%), cough (29%), epistaxis (26%), vomiting (25%), neutropenia (25%), and diarrhea (23%).

The most common grade 3/4 AEs were thrombocytopenia (32%), mucositis (22%), neutropenia (22%), and anemia (18%).

The product monograph for pralatrexate contains a boxed warning highlighting the risk of AEs associated with pralatrexate use, including dermatologic reactions, bone marrow suppression, infection, mucosal inflammation, tumor lysis syndrome, potential fetal harm, and pulmonary toxicity.

The product monograph is available for download from the website of Servier Canada, the company marketing pralatrexate in Canada.

Photo courtesy of AbbVie

The European Commission (EC) has approved a new indication for venetoclax (Venclyxto®).

The drug is now approved for use in combination with rituximab to treat patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

The approval is valid in all member states of the European Union as well as Iceland, Liechtenstein, and Norway.

The EC’s approval is based on results from the phase 3 MURANO trial, which were published in The New England Journal of Medicine in March.

The trial included 389 CLL patients who were randomized to receive venetoclax plus rituximab (VEN+R) or bendamustine plus rituximab (B+R). The median follow-up was 23.8 months.

According to an independent review committee, the overall response rate was 92.3% in the VEN+R arm and 72.3% in the B+R arm. The investigator-assessed overall response rates were 93.3% and 67.7%, respectively.

According to investigators, the median progression-free survival (PFS) was not reached in the VEN+R arm and was 17.0 months in the B+R arm (hazard ratio [HR]=0.17; P<0.0001).

According to the independent review committee, the median PFS was not reached in the VEN+R arm and was 18.1 months in the B+R arm (HR=0.20; P<0.0001).

Investigators said the 2-year PFS rate was 84.9% in the VEN+R arm and 36.3% in the B+R arm.

They said the 2-year overall survival rates were 91.9% and 86.6%, respectively (HR=0.48; P<0.0001). The median overall survival was not reached in either arm.

Grade 3/4 adverse events (AEs) with at least a 2% difference in incidence between the treatment arms (in the VEN+R and B+R arms, respectively) included:

• Neutropenia (57.7% and 38.8%)
• Infections and infestations (17.5% and 21.8%)
• Anemia (10.8% and 13.8%)
• Thrombocytopenia (5.7% and 10.1%)
• Febrile neutropenia (3.6% and 9.6%)
• Pneumonia (5.2% and 8.0%)
• Infusion-related reactions (1.5% and 5.3%)
• Tumor lysis syndrome (3.1% and 1.1%)
• Hypotension (0% and 2.7%)
• Hyperglycemia (2.1% and 0%)
• Hypogammaglobulinemia (2.1% and 0%).

Serious AEs with at least a 2% difference in incidence between the arms (in the VEN+R and B+R arms, respectively) were:

• Pneumonia (8.2% and 8.0%)
• Febrile neutropenia (3.6% and 8.5%)
• Pyrexia (2.6% and 6.9%)
• Anemia (1.5% and 2.7%)
• Infusion-related reactions (0.5% and 3.2%)
• Sepsis (0.5% and 2.1%)
• Tumor lysis syndrome (2.1% and 0.5%)
• Hypotension (0% and 2.7%).

Fatal AEs occurred in 5.2% of patients in the VEN+R arm and 5.9% in the B+R arm.

Fatal AEs in the VEN+R arm included pneumonia (n=3), sepsis (n=1), thrombocytopenia (n=1), cardiac failure (n=1), myocardial infarction (n=1), sudden cardiac death (n=1), colorectal cancer (n=1), status epilepticus (n=1), and acute respiratory failure (n=1). Two cases of pneumonia occurred in the setting of progression/Richter’s transformation.

Photo courtesy of AbbVie

The European Commission (EC) has approved a new indication for venetoclax (Venclyxto®).

The drug is now approved for use in combination with rituximab to treat patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

The approval is valid in all member states of the European Union as well as Iceland, Liechtenstein, and Norway.

The EC’s approval is based on results from the phase 3 MURANO trial, which were published in The New England Journal of Medicine in March.

The trial included 389 CLL patients who were randomized to receive venetoclax plus rituximab (VEN+R) or bendamustine plus rituximab (B+R). The median follow-up was 23.8 months.

According to an independent review committee, the overall response rate was 92.3% in the VEN+R arm and 72.3% in the B+R arm. The investigator-assessed overall response rates were 93.3% and 67.7%, respectively.

According to investigators, the median progression-free survival (PFS) was not reached in the VEN+R arm and was 17.0 months in the B+R arm (hazard ratio [HR]=0.17; P<0.0001).

According to the independent review committee, the median PFS was not reached in the VEN+R arm and was 18.1 months in the B+R arm (HR=0.20; P<0.0001).

Investigators said the 2-year PFS rate was 84.9% in the VEN+R arm and 36.3% in the B+R arm.

They said the 2-year overall survival rates were 91.9% and 86.6%, respectively (HR=0.48; P<0.0001). The median overall survival was not reached in either arm.

Grade 3/4 adverse events (AEs) with at least a 2% difference in incidence between the treatment arms (in the VEN+R and B+R arms, respectively) included:

• Neutropenia (57.7% and 38.8%)
• Infections and infestations (17.5% and 21.8%)
• Anemia (10.8% and 13.8%)
• Thrombocytopenia (5.7% and 10.1%)
• Febrile neutropenia (3.6% and 9.6%)
• Pneumonia (5.2% and 8.0%)
• Infusion-related reactions (1.5% and 5.3%)
• Tumor lysis syndrome (3.1% and 1.1%)
• Hypotension (0% and 2.7%)
• Hyperglycemia (2.1% and 0%)
• Hypogammaglobulinemia (2.1% and 0%).

Serious AEs with at least a 2% difference in incidence between the arms (in the VEN+R and B+R arms, respectively) were:

• Pneumonia (8.2% and 8.0%)
• Febrile neutropenia (3.6% and 8.5%)
• Pyrexia (2.6% and 6.9%)
• Anemia (1.5% and 2.7%)
• Infusion-related reactions (0.5% and 3.2%)
• Sepsis (0.5% and 2.1%)
• Tumor lysis syndrome (2.1% and 0.5%)
• Hypotension (0% and 2.7%).

Fatal AEs occurred in 5.2% of patients in the VEN+R arm and 5.9% in the B+R arm.

Fatal AEs in the VEN+R arm included pneumonia (n=3), sepsis (n=1), thrombocytopenia (n=1), cardiac failure (n=1), myocardial infarction (n=1), sudden cardiac death (n=1), colorectal cancer (n=1), status epilepticus (n=1), and acute respiratory failure (n=1). Two cases of pneumonia occurred in the setting of progression/Richter’s transformation.

Photo courtesy of AbbVie

The European Commission (EC) has approved a new indication for venetoclax (Venclyxto®).

The drug is now approved for use in combination with rituximab to treat patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

The approval is valid in all member states of the European Union as well as Iceland, Liechtenstein, and Norway.

The EC’s approval is based on results from the phase 3 MURANO trial, which were published in The New England Journal of Medicine in March.

The trial included 389 CLL patients who were randomized to receive venetoclax plus rituximab (VEN+R) or bendamustine plus rituximab (B+R). The median follow-up was 23.8 months.

According to an independent review committee, the overall response rate was 92.3% in the VEN+R arm and 72.3% in the B+R arm. The investigator-assessed overall response rates were 93.3% and 67.7%, respectively.

According to investigators, the median progression-free survival (PFS) was not reached in the VEN+R arm and was 17.0 months in the B+R arm (hazard ratio [HR]=0.17; P<0.0001).

According to the independent review committee, the median PFS was not reached in the VEN+R arm and was 18.1 months in the B+R arm (HR=0.20; P<0.0001).

Investigators said the 2-year PFS rate was 84.9% in the VEN+R arm and 36.3% in the B+R arm.

They said the 2-year overall survival rates were 91.9% and 86.6%, respectively (HR=0.48; P<0.0001). The median overall survival was not reached in either arm.

Grade 3/4 adverse events (AEs) with at least a 2% difference in incidence between the treatment arms (in the VEN+R and B+R arms, respectively) included:

• Neutropenia (57.7% and 38.8%)
• Infections and infestations (17.5% and 21.8%)
• Anemia (10.8% and 13.8%)
• Thrombocytopenia (5.7% and 10.1%)
• Febrile neutropenia (3.6% and 9.6%)
• Pneumonia (5.2% and 8.0%)
• Infusion-related reactions (1.5% and 5.3%)
• Tumor lysis syndrome (3.1% and 1.1%)
• Hypotension (0% and 2.7%)
• Hyperglycemia (2.1% and 0%)
• Hypogammaglobulinemia (2.1% and 0%).

Serious AEs with at least a 2% difference in incidence between the arms (in the VEN+R and B+R arms, respectively) were:

• Pneumonia (8.2% and 8.0%)
• Febrile neutropenia (3.6% and 8.5%)
• Pyrexia (2.6% and 6.9%)
• Anemia (1.5% and 2.7%)
• Infusion-related reactions (0.5% and 3.2%)
• Sepsis (0.5% and 2.1%)
• Tumor lysis syndrome (2.1% and 0.5%)
• Hypotension (0% and 2.7%).

Fatal AEs occurred in 5.2% of patients in the VEN+R arm and 5.9% in the B+R arm.

Fatal AEs in the VEN+R arm included pneumonia (n=3), sepsis (n=1), thrombocytopenia (n=1), cardiac failure (n=1), myocardial infarction (n=1), sudden cardiac death (n=1), colorectal cancer (n=1), status epilepticus (n=1), and acute respiratory failure (n=1). Two cases of pneumonia occurred in the setting of progression/Richter’s transformation.

Warfarin tablets

The U.S. Food and Drug Administration (FDA) announced a Class I recall of test strips used with medical devices that monitor warfarin levels, which means use of these strips may cause serious injuries or death.

Roche Diagnostics has recalled certain test strip lots used with its CoaguChek test meter devices.

The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from January 12, 2018, to October 29, 2018.

The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.

The FDA said patients and healthcare professionals should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, patients should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.

“These strips are widely used, and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.

“Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients. We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and healthcare providers as quickly as possible.”

The FDA’s warning concerning the CoaguChek XS PT Test Strips is based on medical device reports submitted by Roche Diagnostics indicating that the test strips may provide results that are higher than the actual international normalized ratio (INR).

As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk of thrombosis.

Approximately 90 medical device reports and two serious patient injuries involving strokes were reported to the FDA.

Roche Diagnostics attributes the cause of the problem to a recent recalibration of the test strips to a different international standard.

The company plans to provide new batches of recalibrated test strips, based on the previous international standard, to their customers by the end of November.

The FDA reviewed validation data submitted by the company for these recalibrated strips.

Patients who are using CoaguChek meters should contact their healthcare provider to get information about alternative test methods and to address questions regarding their individual testing schedule. Patients should also contact their self-testing service providers to find out when they will be getting their corrected test strips.

For questions about the recall or to report adverse reactions or quality problems, contact Roche Diagnostics Point of Care Technical Service at 1-800-428-4674.

Adverse reactions can also be reported to the FDA through MedWatch, the agency’s voluntary reporting program.

Warfarin tablets

The U.S. Food and Drug Administration (FDA) announced a Class I recall of test strips used with medical devices that monitor warfarin levels, which means use of these strips may cause serious injuries or death.

Roche Diagnostics has recalled certain test strip lots used with its CoaguChek test meter devices.

The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from January 12, 2018, to October 29, 2018.

The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.

The FDA said patients and healthcare professionals should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, patients should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.

“These strips are widely used, and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.

“Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients. We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and healthcare providers as quickly as possible.”

The FDA’s warning concerning the CoaguChek XS PT Test Strips is based on medical device reports submitted by Roche Diagnostics indicating that the test strips may provide results that are higher than the actual international normalized ratio (INR).

As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk of thrombosis.

Approximately 90 medical device reports and two serious patient injuries involving strokes were reported to the FDA.

Roche Diagnostics attributes the cause of the problem to a recent recalibration of the test strips to a different international standard.

The company plans to provide new batches of recalibrated test strips, based on the previous international standard, to their customers by the end of November.

The FDA reviewed validation data submitted by the company for these recalibrated strips.

Patients who are using CoaguChek meters should contact their healthcare provider to get information about alternative test methods and to address questions regarding their individual testing schedule. Patients should also contact their self-testing service providers to find out when they will be getting their corrected test strips.

For questions about the recall or to report adverse reactions or quality problems, contact Roche Diagnostics Point of Care Technical Service at 1-800-428-4674.

Adverse reactions can also be reported to the FDA through MedWatch, the agency’s voluntary reporting program.

Warfarin tablets

The U.S. Food and Drug Administration (FDA) announced a Class I recall of test strips used with medical devices that monitor warfarin levels, which means use of these strips may cause serious injuries or death.

Roche Diagnostics has recalled certain test strip lots used with its CoaguChek test meter devices.

The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from January 12, 2018, to October 29, 2018.

The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.

The FDA said patients and healthcare professionals should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, patients should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.

“These strips are widely used, and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.

“Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients. We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and healthcare providers as quickly as possible.”

The FDA’s warning concerning the CoaguChek XS PT Test Strips is based on medical device reports submitted by Roche Diagnostics indicating that the test strips may provide results that are higher than the actual international normalized ratio (INR).

As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk of thrombosis.

Approximately 90 medical device reports and two serious patient injuries involving strokes were reported to the FDA.

Roche Diagnostics attributes the cause of the problem to a recent recalibration of the test strips to a different international standard.

The company plans to provide new batches of recalibrated test strips, based on the previous international standard, to their customers by the end of November.

The FDA reviewed validation data submitted by the company for these recalibrated strips.

Patients who are using CoaguChek meters should contact their healthcare provider to get information about alternative test methods and to address questions regarding their individual testing schedule. Patients should also contact their self-testing service providers to find out when they will be getting their corrected test strips.

For questions about the recall or to report adverse reactions or quality problems, contact Roche Diagnostics Point of Care Technical Service at 1-800-428-4674.

Adverse reactions can also be reported to the FDA through MedWatch, the agency’s voluntary reporting program.

A joint panel of the Food and Drug Administration voted Nov. 1 against approving a new opioid-containing drug as an adjunctive treatment for major depressive disorder.

The 21-2 vote against approval by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based on concerns that the drug’s benefit-risk profile was not strong enough to warrant approval, according to a press release from Alkermes, developer of the drug, which is a combination of buprenorphine and samidorphan known as ALKS 5461.

“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the advisory committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants, Richard Pops, chief executive officer of Alkermes, said in the release. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”

At the meeting, Sanjay J. Mathew, MD, a psychiatrist affiliated with the Baylor College of Medicine in Houston and a consultant for Alkermes who was paid for his time and travel to the meeting, discussed which patients might be good candidates for the new drug. He used an example of a patient who had failed on several monotherapies and would consider augmentation with a second drug. “In my view, this drug has a positive benefit-risk profile with a comparable efficacy” to currently available drugs, but with a new distinct mechanism that appears not to have certain undesirable side effects such as weight gain and sleepiness, he said.

Meanwhile, representatives from Alkermes discussed phase 3 studies, in which adults with treatment-resistant major depressive disorder were randomized to BUP/SAM in doses of 1mg/1mg or 2mg/2mg, or a placebo. In the trial, known as Study 207, changes in the MADRAS-10 total scores were significantly higher in the 2mg/2mg treatment groups, compared with placebo when data from 5 weeks and 6 weeks of treatment were combined.

However, in the FDA’s review of the data, it was noted that the efficacy was based on the MADRAS-10 average vs. the MADRAS-10 end of treatment, and the average “tends to obscure a possible drop-off in drug efficacy after the first few weeks of treatment.”

The FDA usually follows its panels’ recommendations, which are not binding.

A joint panel of the Food and Drug Administration voted Nov. 1 against approving a new opioid-containing drug as an adjunctive treatment for major depressive disorder.

The 21-2 vote against approval by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based on concerns that the drug’s benefit-risk profile was not strong enough to warrant approval, according to a press release from Alkermes, developer of the drug, which is a combination of buprenorphine and samidorphan known as ALKS 5461.

“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the advisory committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants, Richard Pops, chief executive officer of Alkermes, said in the release. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”

At the meeting, Sanjay J. Mathew, MD, a psychiatrist affiliated with the Baylor College of Medicine in Houston and a consultant for Alkermes who was paid for his time and travel to the meeting, discussed which patients might be good candidates for the new drug. He used an example of a patient who had failed on several monotherapies and would consider augmentation with a second drug. “In my view, this drug has a positive benefit-risk profile with a comparable efficacy” to currently available drugs, but with a new distinct mechanism that appears not to have certain undesirable side effects such as weight gain and sleepiness, he said.

Meanwhile, representatives from Alkermes discussed phase 3 studies, in which adults with treatment-resistant major depressive disorder were randomized to BUP/SAM in doses of 1mg/1mg or 2mg/2mg, or a placebo. In the trial, known as Study 207, changes in the MADRAS-10 total scores were significantly higher in the 2mg/2mg treatment groups, compared with placebo when data from 5 weeks and 6 weeks of treatment were combined.

However, in the FDA’s review of the data, it was noted that the efficacy was based on the MADRAS-10 average vs. the MADRAS-10 end of treatment, and the average “tends to obscure a possible drop-off in drug efficacy after the first few weeks of treatment.”

The FDA usually follows its panels’ recommendations, which are not binding.

A joint panel of the Food and Drug Administration voted Nov. 1 against approving a new opioid-containing drug as an adjunctive treatment for major depressive disorder.

The 21-2 vote against approval by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based on concerns that the drug’s benefit-risk profile was not strong enough to warrant approval, according to a press release from Alkermes, developer of the drug, which is a combination of buprenorphine and samidorphan known as ALKS 5461.

“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the advisory committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants, Richard Pops, chief executive officer of Alkermes, said in the release. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”

At the meeting, Sanjay J. Mathew, MD, a psychiatrist affiliated with the Baylor College of Medicine in Houston and a consultant for Alkermes who was paid for his time and travel to the meeting, discussed which patients might be good candidates for the new drug. He used an example of a patient who had failed on several monotherapies and would consider augmentation with a second drug. “In my view, this drug has a positive benefit-risk profile with a comparable efficacy” to currently available drugs, but with a new distinct mechanism that appears not to have certain undesirable side effects such as weight gain and sleepiness, he said.

Meanwhile, representatives from Alkermes discussed phase 3 studies, in which adults with treatment-resistant major depressive disorder were randomized to BUP/SAM in doses of 1mg/1mg or 2mg/2mg, or a placebo. In the trial, known as Study 207, changes in the MADRAS-10 total scores were significantly higher in the 2mg/2mg treatment groups, compared with placebo when data from 5 weeks and 6 weeks of treatment were combined.

However, in the FDA’s review of the data, it was noted that the efficacy was based on the MADRAS-10 average vs. the MADRAS-10 end of treatment, and the average “tends to obscure a possible drop-off in drug efficacy after the first few weeks of treatment.”

The FDA usually follows its panels’ recommendations, which are not binding.

LAS VEGAS – An investigational oral therapy for onychomycosis could be on the horizon as a new treatment option.

VT-1161 is a cytochrome P51 (CYP51) inhibitor with potent in vitro activity against several species of tinea and yeast, David M. Pariser, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. It is highly selective for fungal CYP51 over human cytochrome P enzymes.

LAS VEGAS – An investigational oral therapy for onychomycosis could be on the horizon as a new treatment option.

VT-1161 is a cytochrome P51 (CYP51) inhibitor with potent in vitro activity against several species of tinea and yeast, David M. Pariser, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. It is highly selective for fungal CYP51 over human cytochrome P enzymes.

LAS VEGAS – An investigational oral therapy for onychomycosis could be on the horizon as a new treatment option.

VT-1161 is a cytochrome P51 (CYP51) inhibitor with potent in vitro activity against several species of tinea and yeast, David M. Pariser, MD, said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. It is highly selective for fungal CYP51 over human cytochrome P enzymes.

Unless you decide to start a second career as an expert witness, giving a deposition is a challenge you should avoid at all costs. I have given a few depositions myself, as both a defendant and a witness, and I have reviewed a dozen or more as a consultant for a local law firm. It is an unnatural and artificial format for transferring information. You will survive the depositions rigid and arbitrary rules only by listening to and following your lawyer’s coaching both before and during the deposition. Hopefully you never will be deposed. However, it may be instructive to consider the deposition’s unsettling format as a way to improve your communication skills with patients, parents, and nonphysicians.

belchonock/Thinkstock

First, in a deposition every word you utter is recorded. There are no second chances to edit or clarify what you have said. Your words must be carefully chosen. Several times each year I encounter the parent of a former patient in the grocery store who quotes to me some advice they claim I gave them 2 or 3 decades ago. Although I can imagine that I might have voiced the message they are remembering, sometimes I have to cringe at the bluntness and the crude choice of words they are attributing to me. Obviously, I got away with my fast and loose handling of the English language most of the time and am flattered that it was memorable. But I wonder how often I offended a family with my shoot-from-the-hip advice.

In a similar vein, I found that one of the benefits of having medical students shadow me around the office was that their presence forced me to listen to myself. Did I really say that? How sloppy had I gotten in my explanations to parents and patients? Having another pair of ears in the office can be like having a court stenographer at your deposition.

The situation can be particularly insidious when a parent asks what you take to be a rhetorical question or more likely makes a statement that is incorrect, but you fail to correct it because it is off topic and you are in a hurry to get to the next exam room. If in a deposition the plaintiff’s lawyer prefaces a question with “We all know that sugar makes children hyper,” before you leap over his preface and give your answer you should respond that you are unaware of any scientific evidence that supports his assertion. But if a parent offhandedly mentions that his child was on a “sugar high” you might not take the time to disagree because the parent’s observation had no significance to the history he was relating. However, the parent could interpret from your silence that you believe sugar causes hyperactivity.

Of course the volume of old wives tales, urban legends, and chat room myths that float by you in the office every day makes it impractical to counter every bit of misinformation we hear. But the rules of deposition should remind us that our failure to disagree might sometimes be interpreted as an agreement.

One of the more difficult concepts challenging the deposed physician is avoiding the too much information trap. Your answers in a deposition should be simple and to the point. Physicians are trained to teach. How often are we clouding the answers the patients want by trying to impress them with our breadth of knowledge and command of scientific language?

Although you may have a scribe helping you craft your electronic medical records, hopefully he or she won’t be a court stenographer. And even more fortunately, most patients and parents aren’t listening to every word you say. But from time to time, it helps to pretend you are being deposed. Or at least take a moment to listen to what you have been saying.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Unless you decide to start a second career as an expert witness, giving a deposition is a challenge you should avoid at all costs. I have given a few depositions myself, as both a defendant and a witness, and I have reviewed a dozen or more as a consultant for a local law firm. It is an unnatural and artificial format for transferring information. You will survive the depositions rigid and arbitrary rules only by listening to and following your lawyer’s coaching both before and during the deposition. Hopefully you never will be deposed. However, it may be instructive to consider the deposition’s unsettling format as a way to improve your communication skills with patients, parents, and nonphysicians.

belchonock/Thinkstock

First, in a deposition every word you utter is recorded. There are no second chances to edit or clarify what you have said. Your words must be carefully chosen. Several times each year I encounter the parent of a former patient in the grocery store who quotes to me some advice they claim I gave them 2 or 3 decades ago. Although I can imagine that I might have voiced the message they are remembering, sometimes I have to cringe at the bluntness and the crude choice of words they are attributing to me. Obviously, I got away with my fast and loose handling of the English language most of the time and am flattered that it was memorable. But I wonder how often I offended a family with my shoot-from-the-hip advice.

In a similar vein, I found that one of the benefits of having medical students shadow me around the office was that their presence forced me to listen to myself. Did I really say that? How sloppy had I gotten in my explanations to parents and patients? Having another pair of ears in the office can be like having a court stenographer at your deposition.

The situation can be particularly insidious when a parent asks what you take to be a rhetorical question or more likely makes a statement that is incorrect, but you fail to correct it because it is off topic and you are in a hurry to get to the next exam room. If in a deposition the plaintiff’s lawyer prefaces a question with “We all know that sugar makes children hyper,” before you leap over his preface and give your answer you should respond that you are unaware of any scientific evidence that supports his assertion. But if a parent offhandedly mentions that his child was on a “sugar high” you might not take the time to disagree because the parent’s observation had no significance to the history he was relating. However, the parent could interpret from your silence that you believe sugar causes hyperactivity.

Of course the volume of old wives tales, urban legends, and chat room myths that float by you in the office every day makes it impractical to counter every bit of misinformation we hear. But the rules of deposition should remind us that our failure to disagree might sometimes be interpreted as an agreement.

One of the more difficult concepts challenging the deposed physician is avoiding the too much information trap. Your answers in a deposition should be simple and to the point. Physicians are trained to teach. How often are we clouding the answers the patients want by trying to impress them with our breadth of knowledge and command of scientific language?

Although you may have a scribe helping you craft your electronic medical records, hopefully he or she won’t be a court stenographer. And even more fortunately, most patients and parents aren’t listening to every word you say. But from time to time, it helps to pretend you are being deposed. Or at least take a moment to listen to what you have been saying.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

Unless you decide to start a second career as an expert witness, giving a deposition is a challenge you should avoid at all costs. I have given a few depositions myself, as both a defendant and a witness, and I have reviewed a dozen or more as a consultant for a local law firm. It is an unnatural and artificial format for transferring information. You will survive the depositions rigid and arbitrary rules only by listening to and following your lawyer’s coaching both before and during the deposition. Hopefully you never will be deposed. However, it may be instructive to consider the deposition’s unsettling format as a way to improve your communication skills with patients, parents, and nonphysicians.

belchonock/Thinkstock

First, in a deposition every word you utter is recorded. There are no second chances to edit or clarify what you have said. Your words must be carefully chosen. Several times each year I encounter the parent of a former patient in the grocery store who quotes to me some advice they claim I gave them 2 or 3 decades ago. Although I can imagine that I might have voiced the message they are remembering, sometimes I have to cringe at the bluntness and the crude choice of words they are attributing to me. Obviously, I got away with my fast and loose handling of the English language most of the time and am flattered that it was memorable. But I wonder how often I offended a family with my shoot-from-the-hip advice.

In a similar vein, I found that one of the benefits of having medical students shadow me around the office was that their presence forced me to listen to myself. Did I really say that? How sloppy had I gotten in my explanations to parents and patients? Having another pair of ears in the office can be like having a court stenographer at your deposition.

The situation can be particularly insidious when a parent asks what you take to be a rhetorical question or more likely makes a statement that is incorrect, but you fail to correct it because it is off topic and you are in a hurry to get to the next exam room. If in a deposition the plaintiff’s lawyer prefaces a question with “We all know that sugar makes children hyper,” before you leap over his preface and give your answer you should respond that you are unaware of any scientific evidence that supports his assertion. But if a parent offhandedly mentions that his child was on a “sugar high” you might not take the time to disagree because the parent’s observation had no significance to the history he was relating. However, the parent could interpret from your silence that you believe sugar causes hyperactivity.

Of course the volume of old wives tales, urban legends, and chat room myths that float by you in the office every day makes it impractical to counter every bit of misinformation we hear. But the rules of deposition should remind us that our failure to disagree might sometimes be interpreted as an agreement.

One of the more difficult concepts challenging the deposed physician is avoiding the too much information trap. Your answers in a deposition should be simple and to the point. Physicians are trained to teach. How often are we clouding the answers the patients want by trying to impress them with our breadth of knowledge and command of scientific language?

Although you may have a scribe helping you craft your electronic medical records, hopefully he or she won’t be a court stenographer. And even more fortunately, most patients and parents aren’t listening to every word you say. But from time to time, it helps to pretend you are being deposed. Or at least take a moment to listen to what you have been saying.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].