News

Updated clinical guidelines for diagnosis and treatment of chronic lymphocytic leukemia (CLL) include new and revised recommendations based on major advances in genomics, targeted therapies, and biomarkers that have occurred since the last iteration in 2008.

The guidelines are an update from a consensus document issued a decade ago by the International Workshop on CLL, focusing on the conduct of clinical trials in patients with CLL. The new guidelines are published in Blood.

Major changes or additions include:

Molecular genetics: The updated guidelines recognize the clinical importance of specific genomic alterations/mutations on response to standard chemotherapy or chemoimmunotherapy, including the 17p deletion and mutations in TP53.

“Therefore, the assessment of both del(17p) and TP53 mutation has prognostic and predictive value and should guide therapeutic decisions in routine practice. For clinical trials, it is recommended that molecular genetics be performed prior to treating a patient on protocol,” the guidelines state.

IGHV mutational status: The mutational status of immunoglobulin variable heavy chain (IGHV) genes has been demonstrated to offer important prognostic information, according to the guidelines authors led by Michael Hallek, MD of the University of Cologne, Germany.

Specifically, leukemia with IGHV genes without somatic mutations are associated with worse clinical outcomes, compared with leukemia with IGHV mutations. Patients with mutated IGHV and other prognostic factors such as favorable cytogenetics or minimal residual disease (MRD) negativity generally have excellent outcomes with a chemoimmunotherapy regimen consisting of fludarabine, cyclophosphamide, and rituximab, the authors noted.

Updated clinical guidelines for diagnosis and treatment of chronic lymphocytic leukemia (CLL) include new and revised recommendations based on major advances in genomics, targeted therapies, and biomarkers that have occurred since the last iteration in 2008.

The guidelines are an update from a consensus document issued a decade ago by the International Workshop on CLL, focusing on the conduct of clinical trials in patients with CLL. The new guidelines are published in Blood.

Major changes or additions include:

Molecular genetics: The updated guidelines recognize the clinical importance of specific genomic alterations/mutations on response to standard chemotherapy or chemoimmunotherapy, including the 17p deletion and mutations in TP53.

“Therefore, the assessment of both del(17p) and TP53 mutation has prognostic and predictive value and should guide therapeutic decisions in routine practice. For clinical trials, it is recommended that molecular genetics be performed prior to treating a patient on protocol,” the guidelines state.

IGHV mutational status: The mutational status of immunoglobulin variable heavy chain (IGHV) genes has been demonstrated to offer important prognostic information, according to the guidelines authors led by Michael Hallek, MD of the University of Cologne, Germany.

Specifically, leukemia with IGHV genes without somatic mutations are associated with worse clinical outcomes, compared with leukemia with IGHV mutations. Patients with mutated IGHV and other prognostic factors such as favorable cytogenetics or minimal residual disease (MRD) negativity generally have excellent outcomes with a chemoimmunotherapy regimen consisting of fludarabine, cyclophosphamide, and rituximab, the authors noted.

Updated clinical guidelines for diagnosis and treatment of chronic lymphocytic leukemia (CLL) include new and revised recommendations based on major advances in genomics, targeted therapies, and biomarkers that have occurred since the last iteration in 2008.

The guidelines are an update from a consensus document issued a decade ago by the International Workshop on CLL, focusing on the conduct of clinical trials in patients with CLL. The new guidelines are published in Blood.

Major changes or additions include:

Molecular genetics: The updated guidelines recognize the clinical importance of specific genomic alterations/mutations on response to standard chemotherapy or chemoimmunotherapy, including the 17p deletion and mutations in TP53.

“Therefore, the assessment of both del(17p) and TP53 mutation has prognostic and predictive value and should guide therapeutic decisions in routine practice. For clinical trials, it is recommended that molecular genetics be performed prior to treating a patient on protocol,” the guidelines state.

IGHV mutational status: The mutational status of immunoglobulin variable heavy chain (IGHV) genes has been demonstrated to offer important prognostic information, according to the guidelines authors led by Michael Hallek, MD of the University of Cologne, Germany.

Specifically, leukemia with IGHV genes without somatic mutations are associated with worse clinical outcomes, compared with leukemia with IGHV mutations. Patients with mutated IGHV and other prognostic factors such as favorable cytogenetics or minimal residual disease (MRD) negativity generally have excellent outcomes with a chemoimmunotherapy regimen consisting of fludarabine, cyclophosphamide, and rituximab, the authors noted.

Patients with HIV often also have herpes simplex virus type 2 (HSV-2) infection in part because lesions act as entry portals to susceptible HIV target cells. Some research also has suggested that HSV-2 accelerates HIV progression by upregulating HIV replication and increasing HIV viral load, but data are inconclusive, say researchers from the Iranian Research Center for HIV/AIDS, Pasteur Institute of Iran, Iranian Society for Support of Patients With Infectious Disease, Kermanshah University of Medical Sciences, Tehran University of Medical Sciences, and Zanjan University of Medical Sciences in Iran. They conducted a study to investigate HSV-2 seroprevalence in patients with and without HIV and to find out whether HSV-2 serostatus changed as CD4 counts and HIV viral load changed after 1 year.

The researchers compared 116 HIV patients who were not on HAART with 85 healthy controls. The prevalence and incidence of HSV-2 infection were low in the HIV cases and “negligible” in the control group: 18% of naïve HIV patients had HSV-2 IgG, and none of the control patients did.

Few data exist about HSV-2 seroconversion in HIV patients, the researchers say. In this study, HSV-2 seroconversion was found in 2.43% of HIV patients after 1 year.

Co-infection with HSV-2 had no association with CD4 count and HIV RNA viral load changes in the study participants at baseline or over time, the researchers say. CD4 counts after 1 year were 550 cells/mm³ in the HSV-2 seropositive patients and 563 cells/mm³ in the control group. The viral load in the seropositive group was 3.97 log copies/mL, and 3.49 log copies/mL in the seronegative group.

The researchers conclude that HIV-HSV-2 co-infection does not seem to play a role in HIV infection progression.

Patients with HIV often also have herpes simplex virus type 2 (HSV-2) infection in part because lesions act as entry portals to susceptible HIV target cells. Some research also has suggested that HSV-2 accelerates HIV progression by upregulating HIV replication and increasing HIV viral load, but data are inconclusive, say researchers from the Iranian Research Center for HIV/AIDS, Pasteur Institute of Iran, Iranian Society for Support of Patients With Infectious Disease, Kermanshah University of Medical Sciences, Tehran University of Medical Sciences, and Zanjan University of Medical Sciences in Iran. They conducted a study to investigate HSV-2 seroprevalence in patients with and without HIV and to find out whether HSV-2 serostatus changed as CD4 counts and HIV viral load changed after 1 year.

The researchers compared 116 HIV patients who were not on HAART with 85 healthy controls. The prevalence and incidence of HSV-2 infection were low in the HIV cases and “negligible” in the control group: 18% of naïve HIV patients had HSV-2 IgG, and none of the control patients did.

Few data exist about HSV-2 seroconversion in HIV patients, the researchers say. In this study, HSV-2 seroconversion was found in 2.43% of HIV patients after 1 year.

Co-infection with HSV-2 had no association with CD4 count and HIV RNA viral load changes in the study participants at baseline or over time, the researchers say. CD4 counts after 1 year were 550 cells/mm³ in the HSV-2 seropositive patients and 563 cells/mm³ in the control group. The viral load in the seropositive group was 3.97 log copies/mL, and 3.49 log copies/mL in the seronegative group.

The researchers conclude that HIV-HSV-2 co-infection does not seem to play a role in HIV infection progression.

Patients with HIV often also have herpes simplex virus type 2 (HSV-2) infection in part because lesions act as entry portals to susceptible HIV target cells. Some research also has suggested that HSV-2 accelerates HIV progression by upregulating HIV replication and increasing HIV viral load, but data are inconclusive, say researchers from the Iranian Research Center for HIV/AIDS, Pasteur Institute of Iran, Iranian Society for Support of Patients With Infectious Disease, Kermanshah University of Medical Sciences, Tehran University of Medical Sciences, and Zanjan University of Medical Sciences in Iran. They conducted a study to investigate HSV-2 seroprevalence in patients with and without HIV and to find out whether HSV-2 serostatus changed as CD4 counts and HIV viral load changed after 1 year.

The researchers compared 116 HIV patients who were not on HAART with 85 healthy controls. The prevalence and incidence of HSV-2 infection were low in the HIV cases and “negligible” in the control group: 18% of naïve HIV patients had HSV-2 IgG, and none of the control patients did.

Few data exist about HSV-2 seroconversion in HIV patients, the researchers say. In this study, HSV-2 seroconversion was found in 2.43% of HIV patients after 1 year.

Co-infection with HSV-2 had no association with CD4 count and HIV RNA viral load changes in the study participants at baseline or over time, the researchers say. CD4 counts after 1 year were 550 cells/mm³ in the HSV-2 seropositive patients and 563 cells/mm³ in the control group. The viral load in the seropositive group was 3.97 log copies/mL, and 3.49 log copies/mL in the seronegative group.

The researchers conclude that HIV-HSV-2 co-infection does not seem to play a role in HIV infection progression.

American Indians/Alaska Natives (AI/AN) have a disproportionately high rate of suicide—more than 3.5 times those of racial/ethnic groups with the lowest rates, according to a CDC study. And the rate has been steadily rising since 2003.

Those at highest risk are young people aged 10 to 24 years: More than one-third of suicides have occurred in that group compared with 11% of whites in the same age group.

In the CDC study, about 70% of AI/AN decedents lived in nonmetropolitan areas, including rural areas, which underscores the importance of implementing suicide prevention strategies in rural AI/AN communities, the researchers say. Rural areas often have fewer mental health services due to provider shortages and social barriers, among other factors. The researchers point out that in their study AI/AN had lower odds than did white decedents of having received a mental health diagnosis or mental health treatment.

The researchers also found suggestions of “suicide contagion”; AI/AN decedents were more than twice as likely to have a friend’s or family member’s suicide contribute to their death. Community-level programs that focus on “postvention,” such as survivor support groups, should be considered, the researchers say. They also advise that media should focus on “safe reporting of suicides,” for example, by not using sensationalized headlines.

Nearly 28% of the people who died had reported alcohol abuse problems, and 49% had used alcohol in the hours before their death. The researchers caution that differences in the prevalence of alcohol use among AI/AN might be a symptom of “disproportionate exposure to poverty, historical trauma, and other contexts of inequity and should not be viewed as inherent to AI/AN culture.”

American Indians/Alaska Natives (AI/AN) have a disproportionately high rate of suicide—more than 3.5 times those of racial/ethnic groups with the lowest rates, according to a CDC study. And the rate has been steadily rising since 2003.

Those at highest risk are young people aged 10 to 24 years: More than one-third of suicides have occurred in that group compared with 11% of whites in the same age group.

In the CDC study, about 70% of AI/AN decedents lived in nonmetropolitan areas, including rural areas, which underscores the importance of implementing suicide prevention strategies in rural AI/AN communities, the researchers say. Rural areas often have fewer mental health services due to provider shortages and social barriers, among other factors. The researchers point out that in their study AI/AN had lower odds than did white decedents of having received a mental health diagnosis or mental health treatment.

The researchers also found suggestions of “suicide contagion”; AI/AN decedents were more than twice as likely to have a friend’s or family member’s suicide contribute to their death. Community-level programs that focus on “postvention,” such as survivor support groups, should be considered, the researchers say. They also advise that media should focus on “safe reporting of suicides,” for example, by not using sensationalized headlines.

Nearly 28% of the people who died had reported alcohol abuse problems, and 49% had used alcohol in the hours before their death. The researchers caution that differences in the prevalence of alcohol use among AI/AN might be a symptom of “disproportionate exposure to poverty, historical trauma, and other contexts of inequity and should not be viewed as inherent to AI/AN culture.”

American Indians/Alaska Natives (AI/AN) have a disproportionately high rate of suicide—more than 3.5 times those of racial/ethnic groups with the lowest rates, according to a CDC study. And the rate has been steadily rising since 2003.

Those at highest risk are young people aged 10 to 24 years: More than one-third of suicides have occurred in that group compared with 11% of whites in the same age group.

In the CDC study, about 70% of AI/AN decedents lived in nonmetropolitan areas, including rural areas, which underscores the importance of implementing suicide prevention strategies in rural AI/AN communities, the researchers say. Rural areas often have fewer mental health services due to provider shortages and social barriers, among other factors. The researchers point out that in their study AI/AN had lower odds than did white decedents of having received a mental health diagnosis or mental health treatment.

The researchers also found suggestions of “suicide contagion”; AI/AN decedents were more than twice as likely to have a friend’s or family member’s suicide contribute to their death. Community-level programs that focus on “postvention,” such as survivor support groups, should be considered, the researchers say. They also advise that media should focus on “safe reporting of suicides,” for example, by not using sensationalized headlines.

Nearly 28% of the people who died had reported alcohol abuse problems, and 49% had used alcohol in the hours before their death. The researchers caution that differences in the prevalence of alcohol use among AI/AN might be a symptom of “disproportionate exposure to poverty, historical trauma, and other contexts of inequity and should not be viewed as inherent to AI/AN culture.”

Patients with malignant pleural effusion treated with an indwelling pleural catheter have an improved chance of a positive outcome when talc administration is part of their procedure, suggest the results of a randomized, placebo-controlled study.

Malignant pleural effusion, which is usually caused by the spread of metastatic cancer, is typically treated by inducement of pleurodesis. Talc is probably the most effective agent for achieving this result, but there are drawbacks to using talc to induce pleurodesis. Patients who receive this treatment often need to stay in the hospital for 4-7 days, according to Rahul Bhatnagar, PhD, and the coauthors of a study published in the New England Journal of Medicine). Indwelling pleural catheters provide an “ambulatory alternative” for fluid management, they noted. In a noncomparative series of 22 patients, administering talc through such a catheter produced high rates of pleurodesis, they added.

In the new study, Dr. Bhatnagar of the Academic Respiratory Unit, University of Bristol, England, and his coauthors evaluated the use of an indwelling catheter, with or without talc, in patients with malignant pleural effusion recruited at 18 centers in the United Kingdom over 4 years.

“Our primary-outcome results, which were backed up by robust sensitivity analyses, strongly suggest that the administration of talc through an indwelling pleural catheter was significantly more efficacious than the use of an indwelling pleural catheter alone among patients without substantial lung entrapment,” the authors wrote.

A total of 154 patients underwent randomization to the talc or placebo group, and 139 had sufficient data to evaluate the primary outcome of successful pleurodesis at 35 days after randomization. The researchers excluded patients with evidence of lung entrapment, or nonexpandable lung, according to the study report.

In the talc group, pleurodesis was successful at day 35 in 30 of 69 patients (43%) versus 16 of 70 patients (23%) in the placebo group (P = .008).

At day 70, the success rate was 51% for the talc group vs. 27% for the placebo group, respectively.

The rate of pleurodesis was significantly higher when talc was administered through an indwelling pleural catheter, Dr. Bhatnagar and his colleagues noted.

“Success rates at day 70 suggested that pleurodesis was maintained to a point that is clinically relevant for patients with short median survival,” they added.

No excess of side effects or catheter blockages were associated with talc vs. placebo administration through a catheter. Additionally, no differences were seen between the talc and placebo groups in the number of adverse events, number of inpatient days, mortality, or other outcomes tracked by the researchers.

Dr. Bhatnagar reported he had no disclosures related to the study. Study coauthors reported disclosures related to Becton Dickinson – CareFusion, Rosetrees Trust, GE Medical, and Rocket Medical. Becton Dickinson supported the trial with an unrestricted research grant and supplied catheters and drainage bottles for the study’s participants.

SOURCE: Bhatnagar R et al. N Engl J Med. 2018;378:1313-22.

Patients with malignant pleural effusion treated with an indwelling pleural catheter have an improved chance of a positive outcome when talc administration is part of their procedure, suggest the results of a randomized, placebo-controlled study.

Malignant pleural effusion, which is usually caused by the spread of metastatic cancer, is typically treated by inducement of pleurodesis. Talc is probably the most effective agent for achieving this result, but there are drawbacks to using talc to induce pleurodesis. Patients who receive this treatment often need to stay in the hospital for 4-7 days, according to Rahul Bhatnagar, PhD, and the coauthors of a study published in the New England Journal of Medicine). Indwelling pleural catheters provide an “ambulatory alternative” for fluid management, they noted. In a noncomparative series of 22 patients, administering talc through such a catheter produced high rates of pleurodesis, they added.

In the new study, Dr. Bhatnagar of the Academic Respiratory Unit, University of Bristol, England, and his coauthors evaluated the use of an indwelling catheter, with or without talc, in patients with malignant pleural effusion recruited at 18 centers in the United Kingdom over 4 years.

“Our primary-outcome results, which were backed up by robust sensitivity analyses, strongly suggest that the administration of talc through an indwelling pleural catheter was significantly more efficacious than the use of an indwelling pleural catheter alone among patients without substantial lung entrapment,” the authors wrote.

A total of 154 patients underwent randomization to the talc or placebo group, and 139 had sufficient data to evaluate the primary outcome of successful pleurodesis at 35 days after randomization. The researchers excluded patients with evidence of lung entrapment, or nonexpandable lung, according to the study report.

In the talc group, pleurodesis was successful at day 35 in 30 of 69 patients (43%) versus 16 of 70 patients (23%) in the placebo group (P = .008).

At day 70, the success rate was 51% for the talc group vs. 27% for the placebo group, respectively.

The rate of pleurodesis was significantly higher when talc was administered through an indwelling pleural catheter, Dr. Bhatnagar and his colleagues noted.

“Success rates at day 70 suggested that pleurodesis was maintained to a point that is clinically relevant for patients with short median survival,” they added.

No excess of side effects or catheter blockages were associated with talc vs. placebo administration through a catheter. Additionally, no differences were seen between the talc and placebo groups in the number of adverse events, number of inpatient days, mortality, or other outcomes tracked by the researchers.

Dr. Bhatnagar reported he had no disclosures related to the study. Study coauthors reported disclosures related to Becton Dickinson – CareFusion, Rosetrees Trust, GE Medical, and Rocket Medical. Becton Dickinson supported the trial with an unrestricted research grant and supplied catheters and drainage bottles for the study’s participants.

SOURCE: Bhatnagar R et al. N Engl J Med. 2018;378:1313-22.

Patients with malignant pleural effusion treated with an indwelling pleural catheter have an improved chance of a positive outcome when talc administration is part of their procedure, suggest the results of a randomized, placebo-controlled study.

Malignant pleural effusion, which is usually caused by the spread of metastatic cancer, is typically treated by inducement of pleurodesis. Talc is probably the most effective agent for achieving this result, but there are drawbacks to using talc to induce pleurodesis. Patients who receive this treatment often need to stay in the hospital for 4-7 days, according to Rahul Bhatnagar, PhD, and the coauthors of a study published in the New England Journal of Medicine). Indwelling pleural catheters provide an “ambulatory alternative” for fluid management, they noted. In a noncomparative series of 22 patients, administering talc through such a catheter produced high rates of pleurodesis, they added.

In the new study, Dr. Bhatnagar of the Academic Respiratory Unit, University of Bristol, England, and his coauthors evaluated the use of an indwelling catheter, with or without talc, in patients with malignant pleural effusion recruited at 18 centers in the United Kingdom over 4 years.

“Our primary-outcome results, which were backed up by robust sensitivity analyses, strongly suggest that the administration of talc through an indwelling pleural catheter was significantly more efficacious than the use of an indwelling pleural catheter alone among patients without substantial lung entrapment,” the authors wrote.

A total of 154 patients underwent randomization to the talc or placebo group, and 139 had sufficient data to evaluate the primary outcome of successful pleurodesis at 35 days after randomization. The researchers excluded patients with evidence of lung entrapment, or nonexpandable lung, according to the study report.

In the talc group, pleurodesis was successful at day 35 in 30 of 69 patients (43%) versus 16 of 70 patients (23%) in the placebo group (P = .008).

At day 70, the success rate was 51% for the talc group vs. 27% for the placebo group, respectively.

The rate of pleurodesis was significantly higher when talc was administered through an indwelling pleural catheter, Dr. Bhatnagar and his colleagues noted.

“Success rates at day 70 suggested that pleurodesis was maintained to a point that is clinically relevant for patients with short median survival,” they added.

No excess of side effects or catheter blockages were associated with talc vs. placebo administration through a catheter. Additionally, no differences were seen between the talc and placebo groups in the number of adverse events, number of inpatient days, mortality, or other outcomes tracked by the researchers.

Dr. Bhatnagar reported he had no disclosures related to the study. Study coauthors reported disclosures related to Becton Dickinson – CareFusion, Rosetrees Trust, GE Medical, and Rocket Medical. Becton Dickinson supported the trial with an unrestricted research grant and supplied catheters and drainage bottles for the study’s participants.

SOURCE: Bhatnagar R et al. N Engl J Med. 2018;378:1313-22.

Tenofovir disoproxil fumarate (TDF), an antiviral used to treat hepatitis B virus (HBV) infection, does not significantly reduce mother-to-child transmission of the virus when taken during pregnancy and after delivery, according to an NIH-funded phase 3 study.

The limited evidence of benefit from antiviral drugs to prevent mother-to-child transmission of HBV has led to conflicting practice recommendations, says Nahida Chakhtoura, MD, a member of the study team and medical officer at the National Institute of Child Health and Human Development. The World Health Organization recommends that all newborns receive their first dose of HBV vaccine within 24 hours of delivery. Those born to HBV-infected mothers also are given hepatitis B immune globulin (HBIG) for added protection. However, infants are still at risk for the virus if the mother has high levels of virus or mutated versions.

The study, conducted at 17 hospitals in Thailand, enrolled 331 pregnant women with HBV. The women received placebo or TDF at intervals from 28 weeks of pregnancy to 2 months after delivery. All 294 infants received HBIG and 5 doses of the HBV vaccine and were followed through age 6 months.

Three infants in the placebo group and none of the TDF group had HBV infection at 6 months. “Our study suggests that adding TDF to the current regimen seems to have little effect on infant infection rates when transmission rates are already low,” Chakhtoura says

Tenofovir disoproxil fumarate (TDF), an antiviral used to treat hepatitis B virus (HBV) infection, does not significantly reduce mother-to-child transmission of the virus when taken during pregnancy and after delivery, according to an NIH-funded phase 3 study.

The limited evidence of benefit from antiviral drugs to prevent mother-to-child transmission of HBV has led to conflicting practice recommendations, says Nahida Chakhtoura, MD, a member of the study team and medical officer at the National Institute of Child Health and Human Development. The World Health Organization recommends that all newborns receive their first dose of HBV vaccine within 24 hours of delivery. Those born to HBV-infected mothers also are given hepatitis B immune globulin (HBIG) for added protection. However, infants are still at risk for the virus if the mother has high levels of virus or mutated versions.

The study, conducted at 17 hospitals in Thailand, enrolled 331 pregnant women with HBV. The women received placebo or TDF at intervals from 28 weeks of pregnancy to 2 months after delivery. All 294 infants received HBIG and 5 doses of the HBV vaccine and were followed through age 6 months.

Three infants in the placebo group and none of the TDF group had HBV infection at 6 months. “Our study suggests that adding TDF to the current regimen seems to have little effect on infant infection rates when transmission rates are already low,” Chakhtoura says

Tenofovir disoproxil fumarate (TDF), an antiviral used to treat hepatitis B virus (HBV) infection, does not significantly reduce mother-to-child transmission of the virus when taken during pregnancy and after delivery, according to an NIH-funded phase 3 study.

The limited evidence of benefit from antiviral drugs to prevent mother-to-child transmission of HBV has led to conflicting practice recommendations, says Nahida Chakhtoura, MD, a member of the study team and medical officer at the National Institute of Child Health and Human Development. The World Health Organization recommends that all newborns receive their first dose of HBV vaccine within 24 hours of delivery. Those born to HBV-infected mothers also are given hepatitis B immune globulin (HBIG) for added protection. However, infants are still at risk for the virus if the mother has high levels of virus or mutated versions.

The study, conducted at 17 hospitals in Thailand, enrolled 331 pregnant women with HBV. The women received placebo or TDF at intervals from 28 weeks of pregnancy to 2 months after delivery. All 294 infants received HBIG and 5 doses of the HBV vaccine and were followed through age 6 months.

Three infants in the placebo group and none of the TDF group had HBV infection at 6 months. “Our study suggests that adding TDF to the current regimen seems to have little effect on infant infection rates when transmission rates are already low,” Chakhtoura says

The oral immunomodulatory drug lenalidomide is active and may provide prolonged responses in certain patients with a rare and aggressive subtype of primary cutaneous lymphoma, according to results of a phase 2 study.

In the study, which comprised 19 patients with primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), 5 patients (26.3%) had a response at 6 months, and there were still 3 patients in response at 12 months. The findings were reported in the Journal of Investigative Dermatology.

In an exploratory analysis, reducing the dose of lenalidomide was associated with prolonged response and improved survival, noted lead author Marie Beylot-Barry, MD, of the dermatology department, Hôpital Saint-André, CHU Bordeaux, France, and her colleagues.

“Lenalidomide at reduced doses may allow prolonged responses in few patients, and represents a therapeutic option in relapsing/refractory PCDLBCL, LT,” the researchers wrote.

Found mostly on the lower limbs of elderly patients, PCDLBCL, LT exhibits aggressive behavior and is associated with a high rate of skin recurrences. First-line therapy for the cutaneous lymphoma is typically rituximab and chemotherapy, regardless of clinical stage or patient age, the researchers wrote, though primary resistance or recurrence after treatment occurs in about half of patients. “In such relapsing or refractory cases, no treatment has demonstrated a sustained benefit thus far,” they noted.

Lenalidomide has already demonstrated efficacy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and it induces inhibition of cell signaling, engaging NF-kappaB signaling. PCDLBCL, LT is marked by genetic alterations leading to the NF-kappaB pathway, which represents a therapeutic target.

Dr. Beylot-Barry and her colleagues initiated a multicenter, single-arm, phase 2 trial of 19 patients refractory/relapsing PCDLBCL, LT. Median progression-free survival in the trial was 4.9 months. The 6-month overall response rate – the primary endpoint of the trial – was 26.3%, which was not significantly superior to a prespecified 20% minimal response rate, according to the researchers.

SOURCE: Beylot-Barry M et al. J Invest Dermatol. 2018 Mar 26. doi: 10.1016/j.jid.2018.03.1516.

The oral immunomodulatory drug lenalidomide is active and may provide prolonged responses in certain patients with a rare and aggressive subtype of primary cutaneous lymphoma, according to results of a phase 2 study.

In the study, which comprised 19 patients with primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), 5 patients (26.3%) had a response at 6 months, and there were still 3 patients in response at 12 months. The findings were reported in the Journal of Investigative Dermatology.

In an exploratory analysis, reducing the dose of lenalidomide was associated with prolonged response and improved survival, noted lead author Marie Beylot-Barry, MD, of the dermatology department, Hôpital Saint-André, CHU Bordeaux, France, and her colleagues.

“Lenalidomide at reduced doses may allow prolonged responses in few patients, and represents a therapeutic option in relapsing/refractory PCDLBCL, LT,” the researchers wrote.

Found mostly on the lower limbs of elderly patients, PCDLBCL, LT exhibits aggressive behavior and is associated with a high rate of skin recurrences. First-line therapy for the cutaneous lymphoma is typically rituximab and chemotherapy, regardless of clinical stage or patient age, the researchers wrote, though primary resistance or recurrence after treatment occurs in about half of patients. “In such relapsing or refractory cases, no treatment has demonstrated a sustained benefit thus far,” they noted.

Lenalidomide has already demonstrated efficacy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and it induces inhibition of cell signaling, engaging NF-kappaB signaling. PCDLBCL, LT is marked by genetic alterations leading to the NF-kappaB pathway, which represents a therapeutic target.

Dr. Beylot-Barry and her colleagues initiated a multicenter, single-arm, phase 2 trial of 19 patients refractory/relapsing PCDLBCL, LT. Median progression-free survival in the trial was 4.9 months. The 6-month overall response rate – the primary endpoint of the trial – was 26.3%, which was not significantly superior to a prespecified 20% minimal response rate, according to the researchers.

SOURCE: Beylot-Barry M et al. J Invest Dermatol. 2018 Mar 26. doi: 10.1016/j.jid.2018.03.1516.

The oral immunomodulatory drug lenalidomide is active and may provide prolonged responses in certain patients with a rare and aggressive subtype of primary cutaneous lymphoma, according to results of a phase 2 study.

In the study, which comprised 19 patients with primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), 5 patients (26.3%) had a response at 6 months, and there were still 3 patients in response at 12 months. The findings were reported in the Journal of Investigative Dermatology.

In an exploratory analysis, reducing the dose of lenalidomide was associated with prolonged response and improved survival, noted lead author Marie Beylot-Barry, MD, of the dermatology department, Hôpital Saint-André, CHU Bordeaux, France, and her colleagues.

“Lenalidomide at reduced doses may allow prolonged responses in few patients, and represents a therapeutic option in relapsing/refractory PCDLBCL, LT,” the researchers wrote.

Found mostly on the lower limbs of elderly patients, PCDLBCL, LT exhibits aggressive behavior and is associated with a high rate of skin recurrences. First-line therapy for the cutaneous lymphoma is typically rituximab and chemotherapy, regardless of clinical stage or patient age, the researchers wrote, though primary resistance or recurrence after treatment occurs in about half of patients. “In such relapsing or refractory cases, no treatment has demonstrated a sustained benefit thus far,” they noted.

Lenalidomide has already demonstrated efficacy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and it induces inhibition of cell signaling, engaging NF-kappaB signaling. PCDLBCL, LT is marked by genetic alterations leading to the NF-kappaB pathway, which represents a therapeutic target.

Dr. Beylot-Barry and her colleagues initiated a multicenter, single-arm, phase 2 trial of 19 patients refractory/relapsing PCDLBCL, LT. Median progression-free survival in the trial was 4.9 months. The 6-month overall response rate – the primary endpoint of the trial – was 26.3%, which was not significantly superior to a prespecified 20% minimal response rate, according to the researchers.

SOURCE: Beylot-Barry M et al. J Invest Dermatol. 2018 Mar 26. doi: 10.1016/j.jid.2018.03.1516.

SAN DIEGO – Among patients hospitalized for acute medical illnesses, the risk of venous thromboembolism (VTE) remained elevated 30-40 days after discharge, results from a large analysis of national data showed.

Moreover, only 7% of at-risk patients received VTE prophylaxis in both the inpatient and outpatient setting.

“The results of this real-world study imply that there is a significantly unmet medical need for effective VTE prophylaxis in both the inpatient and outpatient continuum of care among patients hospitalized for acute medical illnesses,” researchers led by Alpesh Amin, MD, wrote in a poster presented at the biennial summit of the Thrombosis & Hemostasis Societies of North America.

According to Dr. Amin, who chairs the department of medicine at the University of California, Irvine, hospitalized patients with acute medical illnesses face an increased risk for VTE during hospital discharge, mainly within 40 days following hospital admission. However, the treatment patterns of VTE prophylaxis in this patient population have not been well studied in the “real-world” setting. In an effort to improve this area of clinical practice, the researchers used the Marketscan database between Jan. 1, 2012, and June 30, 2015, to identify acutely ill hospitalized patients, such as those with heart failure, respiratory diseases, ischemic stroke, cancer, infectious diseases, and rheumatic diseases. The key outcomes of interest were the proportion of patients receiving inpatient and outpatient VTE prophylaxis and the proportion of patients with VTE events during and after the index hospitalization. They used Kaplan-Meier analysis to examine the risk for VTE events after the index inpatient admission.

The mean age of the 17,895 patients was 58 years, 55% were female, and most (77%) were from the Southern area of the United States. Their mean Charlson Comborbidity Index score prior to hospitalization was 2.2. Nearly all hospitals (87%) were urban based, nonteaching (95%), and large, with 68% having at least 300 beds. Nearly three-quarters of patients (72%) were hospitalized for infectious and respiratory diseases, and the mean length of stay was 5 days.

Dr. Amin and his associates found that 59% of hospitalized patients did not receive any VTE prophylaxis, while only 7% received prophylaxis in both the inpatient and outpatient continuum of care. At the same time, cumulative VTE rates within 40 days of index admission were highest among patients hospitalized for infectious diseases and cancer (3.4% each), followed by those with heart failure (3.1%), respiratory diseases (2%), ischemic stroke (1.5%), and rheumatic diseases (1.3%). The cumulative VTE event rate for the overall study population within 40 days from index hospitalization was nearly 3%, with 60% of VTE events having occurred within 40 days.
 

The study was funded by Portola Pharmaceuticals. Dr. Amin reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Amin A et al. THSNA 2018, Poster 51.

SAN DIEGO – Among patients hospitalized for acute medical illnesses, the risk of venous thromboembolism (VTE) remained elevated 30-40 days after discharge, results from a large analysis of national data showed.

Moreover, only 7% of at-risk patients received VTE prophylaxis in both the inpatient and outpatient setting.

“The results of this real-world study imply that there is a significantly unmet medical need for effective VTE prophylaxis in both the inpatient and outpatient continuum of care among patients hospitalized for acute medical illnesses,” researchers led by Alpesh Amin, MD, wrote in a poster presented at the biennial summit of the Thrombosis & Hemostasis Societies of North America.

According to Dr. Amin, who chairs the department of medicine at the University of California, Irvine, hospitalized patients with acute medical illnesses face an increased risk for VTE during hospital discharge, mainly within 40 days following hospital admission. However, the treatment patterns of VTE prophylaxis in this patient population have not been well studied in the “real-world” setting. In an effort to improve this area of clinical practice, the researchers used the Marketscan database between Jan. 1, 2012, and June 30, 2015, to identify acutely ill hospitalized patients, such as those with heart failure, respiratory diseases, ischemic stroke, cancer, infectious diseases, and rheumatic diseases. The key outcomes of interest were the proportion of patients receiving inpatient and outpatient VTE prophylaxis and the proportion of patients with VTE events during and after the index hospitalization. They used Kaplan-Meier analysis to examine the risk for VTE events after the index inpatient admission.

The mean age of the 17,895 patients was 58 years, 55% were female, and most (77%) were from the Southern area of the United States. Their mean Charlson Comborbidity Index score prior to hospitalization was 2.2. Nearly all hospitals (87%) were urban based, nonteaching (95%), and large, with 68% having at least 300 beds. Nearly three-quarters of patients (72%) were hospitalized for infectious and respiratory diseases, and the mean length of stay was 5 days.

Dr. Amin and his associates found that 59% of hospitalized patients did not receive any VTE prophylaxis, while only 7% received prophylaxis in both the inpatient and outpatient continuum of care. At the same time, cumulative VTE rates within 40 days of index admission were highest among patients hospitalized for infectious diseases and cancer (3.4% each), followed by those with heart failure (3.1%), respiratory diseases (2%), ischemic stroke (1.5%), and rheumatic diseases (1.3%). The cumulative VTE event rate for the overall study population within 40 days from index hospitalization was nearly 3%, with 60% of VTE events having occurred within 40 days.
 

The study was funded by Portola Pharmaceuticals. Dr. Amin reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Amin A et al. THSNA 2018, Poster 51.

SAN DIEGO – Among patients hospitalized for acute medical illnesses, the risk of venous thromboembolism (VTE) remained elevated 30-40 days after discharge, results from a large analysis of national data showed.

Moreover, only 7% of at-risk patients received VTE prophylaxis in both the inpatient and outpatient setting.

“The results of this real-world study imply that there is a significantly unmet medical need for effective VTE prophylaxis in both the inpatient and outpatient continuum of care among patients hospitalized for acute medical illnesses,” researchers led by Alpesh Amin, MD, wrote in a poster presented at the biennial summit of the Thrombosis & Hemostasis Societies of North America.

According to Dr. Amin, who chairs the department of medicine at the University of California, Irvine, hospitalized patients with acute medical illnesses face an increased risk for VTE during hospital discharge, mainly within 40 days following hospital admission. However, the treatment patterns of VTE prophylaxis in this patient population have not been well studied in the “real-world” setting. In an effort to improve this area of clinical practice, the researchers used the Marketscan database between Jan. 1, 2012, and June 30, 2015, to identify acutely ill hospitalized patients, such as those with heart failure, respiratory diseases, ischemic stroke, cancer, infectious diseases, and rheumatic diseases. The key outcomes of interest were the proportion of patients receiving inpatient and outpatient VTE prophylaxis and the proportion of patients with VTE events during and after the index hospitalization. They used Kaplan-Meier analysis to examine the risk for VTE events after the index inpatient admission.

The mean age of the 17,895 patients was 58 years, 55% were female, and most (77%) were from the Southern area of the United States. Their mean Charlson Comborbidity Index score prior to hospitalization was 2.2. Nearly all hospitals (87%) were urban based, nonteaching (95%), and large, with 68% having at least 300 beds. Nearly three-quarters of patients (72%) were hospitalized for infectious and respiratory diseases, and the mean length of stay was 5 days.

Dr. Amin and his associates found that 59% of hospitalized patients did not receive any VTE prophylaxis, while only 7% received prophylaxis in both the inpatient and outpatient continuum of care. At the same time, cumulative VTE rates within 40 days of index admission were highest among patients hospitalized for infectious diseases and cancer (3.4% each), followed by those with heart failure (3.1%), respiratory diseases (2%), ischemic stroke (1.5%), and rheumatic diseases (1.3%). The cumulative VTE event rate for the overall study population within 40 days from index hospitalization was nearly 3%, with 60% of VTE events having occurred within 40 days.
 

The study was funded by Portola Pharmaceuticals. Dr. Amin reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Amin A et al. THSNA 2018, Poster 51.

As many as one-third of workers in some sectors of health care and social service may have hearing loss, according to the researchers at the National Institute for Occupational Safety and Health (NIOSH) who studied audiograms from hundreds of US companies. Theirs is the first known study to estimate and compare the prevalence of noise-exposed worker hearing loss by subsector within the Health Care and Social Assistance (HSA) sector.

Some subsectors had higher than expected prevalence of hearing loss for an industry that has had assumed “low exposure” to noise, NIOSH says. Most of the HSA subsector prevalence estimates ranged from 14% to 18%, but the Medical and Diagnostic Laboratories subsector had 31% prevalence, the Offices of All Other Miscellaneous Health Practitioners had 24% prevalence, and Child Day Care Services had a 52% higher risk compared with that of the reference industry.

NIOSH says successful noise reduction measures have been documented in hospital settings. Exposure to chemotherapy drugs can be better prevented and laboratories can be modified to reduce the level of noise. When noise can’t be removed or reduced to safe levels, NIOSH recommends implementing an effective hearing conservation program.

Hearing loss is the third most common chronic physical condition in the US, NIOSH says. But Elizabeth Masterson, PhD, epidemiologist and lead author of the study, says, “Occupational hearing loss is entirely preventable.”

As many as one-third of workers in some sectors of health care and social service may have hearing loss, according to the researchers at the National Institute for Occupational Safety and Health (NIOSH) who studied audiograms from hundreds of US companies. Theirs is the first known study to estimate and compare the prevalence of noise-exposed worker hearing loss by subsector within the Health Care and Social Assistance (HSA) sector.

Some subsectors had higher than expected prevalence of hearing loss for an industry that has had assumed “low exposure” to noise, NIOSH says. Most of the HSA subsector prevalence estimates ranged from 14% to 18%, but the Medical and Diagnostic Laboratories subsector had 31% prevalence, the Offices of All Other Miscellaneous Health Practitioners had 24% prevalence, and Child Day Care Services had a 52% higher risk compared with that of the reference industry.

NIOSH says successful noise reduction measures have been documented in hospital settings. Exposure to chemotherapy drugs can be better prevented and laboratories can be modified to reduce the level of noise. When noise can’t be removed or reduced to safe levels, NIOSH recommends implementing an effective hearing conservation program.

Hearing loss is the third most common chronic physical condition in the US, NIOSH says. But Elizabeth Masterson, PhD, epidemiologist and lead author of the study, says, “Occupational hearing loss is entirely preventable.”

As many as one-third of workers in some sectors of health care and social service may have hearing loss, according to the researchers at the National Institute for Occupational Safety and Health (NIOSH) who studied audiograms from hundreds of US companies. Theirs is the first known study to estimate and compare the prevalence of noise-exposed worker hearing loss by subsector within the Health Care and Social Assistance (HSA) sector.

Some subsectors had higher than expected prevalence of hearing loss for an industry that has had assumed “low exposure” to noise, NIOSH says. Most of the HSA subsector prevalence estimates ranged from 14% to 18%, but the Medical and Diagnostic Laboratories subsector had 31% prevalence, the Offices of All Other Miscellaneous Health Practitioners had 24% prevalence, and Child Day Care Services had a 52% higher risk compared with that of the reference industry.

NIOSH says successful noise reduction measures have been documented in hospital settings. Exposure to chemotherapy drugs can be better prevented and laboratories can be modified to reduce the level of noise. When noise can’t be removed or reduced to safe levels, NIOSH recommends implementing an effective hearing conservation program.

Hearing loss is the third most common chronic physical condition in the US, NIOSH says. But Elizabeth Masterson, PhD, epidemiologist and lead author of the study, says, “Occupational hearing loss is entirely preventable.”

Hyponatremia is a dangerous complication of major head trauma, and timely diagnosis and treatment can be fraught with “confounding factors” and complexity, say clinicians from the University of Newcastle and John Hunter Hospital in Australia. They reported a case of hyponatremia that required some clinical tightrope walking.

The patient, a 20-year-old university student, had fractured his skull in a skateboard fall while intoxicated. He was started on dexamethasone to reduce the risk of worsening cerebral edema. On day 3, he developed hypo-osmolar hyponatremia, which was worse on day 4, despite treatment, including IV fluid therapy, fluid restriction, and oral salt tablets. Although cognitively the patient was deteriorating, he seemed clinically euvolemic. However, the patient was in negative fluid balance, suggesting renal salt wasting (RSW). After a trial of isotonic normal saline, the patient’s serum sodium level fell further. The patient was then treated for suspected syndrome of inappropriate antidiuretic hormone (SIADH) with a hypertonic saline infusion. The rise in sodium was carefully controlled to avoid rapid overcorrection, which can lead to irreversible neurologic symptoms. Finally, the patient’s sodium level and neurologic status improved.

The clinicians say the case demonstrates the complexity of differentiating between the causes of hyponatremia after head injury. Volume status may be an indicator, they say, but current clinical and laboratory markers of volume status are often limited in accuracy. The hallmark of RSW is volume depletion, whereas diagnosis of SIADH depends on a coexisting euvolemic state (as with the patient).

As many as 10% of victims of traumatic brain injury develop hyponatremia, and it is associated with a worse prognosis, even in mild cases, the clinicians note. Making the right diagnosis is critical—the treatment chosen can easily compromise the outcome. Patients with neurosurgical conditions are often treated with considerable volumes of saline-containing fluid, with consequent dynamic changes in blood and extracellular volumes. Moreover, the patients have elevated levels of adrenergic hormones with their own confounding effects.

In the long term, the patient experienced significant neurologic sequelae, including prolonged posttraumatic amnesia. After extensive rehabilitation he was able to return to the university.

Hyponatremia is a dangerous complication of major head trauma, and timely diagnosis and treatment can be fraught with “confounding factors” and complexity, say clinicians from the University of Newcastle and John Hunter Hospital in Australia. They reported a case of hyponatremia that required some clinical tightrope walking.

The patient, a 20-year-old university student, had fractured his skull in a skateboard fall while intoxicated. He was started on dexamethasone to reduce the risk of worsening cerebral edema. On day 3, he developed hypo-osmolar hyponatremia, which was worse on day 4, despite treatment, including IV fluid therapy, fluid restriction, and oral salt tablets. Although cognitively the patient was deteriorating, he seemed clinically euvolemic. However, the patient was in negative fluid balance, suggesting renal salt wasting (RSW). After a trial of isotonic normal saline, the patient’s serum sodium level fell further. The patient was then treated for suspected syndrome of inappropriate antidiuretic hormone (SIADH) with a hypertonic saline infusion. The rise in sodium was carefully controlled to avoid rapid overcorrection, which can lead to irreversible neurologic symptoms. Finally, the patient’s sodium level and neurologic status improved.

The clinicians say the case demonstrates the complexity of differentiating between the causes of hyponatremia after head injury. Volume status may be an indicator, they say, but current clinical and laboratory markers of volume status are often limited in accuracy. The hallmark of RSW is volume depletion, whereas diagnosis of SIADH depends on a coexisting euvolemic state (as with the patient).

As many as 10% of victims of traumatic brain injury develop hyponatremia, and it is associated with a worse prognosis, even in mild cases, the clinicians note. Making the right diagnosis is critical—the treatment chosen can easily compromise the outcome. Patients with neurosurgical conditions are often treated with considerable volumes of saline-containing fluid, with consequent dynamic changes in blood and extracellular volumes. Moreover, the patients have elevated levels of adrenergic hormones with their own confounding effects.

In the long term, the patient experienced significant neurologic sequelae, including prolonged posttraumatic amnesia. After extensive rehabilitation he was able to return to the university.

Hyponatremia is a dangerous complication of major head trauma, and timely diagnosis and treatment can be fraught with “confounding factors” and complexity, say clinicians from the University of Newcastle and John Hunter Hospital in Australia. They reported a case of hyponatremia that required some clinical tightrope walking.

The patient, a 20-year-old university student, had fractured his skull in a skateboard fall while intoxicated. He was started on dexamethasone to reduce the risk of worsening cerebral edema. On day 3, he developed hypo-osmolar hyponatremia, which was worse on day 4, despite treatment, including IV fluid therapy, fluid restriction, and oral salt tablets. Although cognitively the patient was deteriorating, he seemed clinically euvolemic. However, the patient was in negative fluid balance, suggesting renal salt wasting (RSW). After a trial of isotonic normal saline, the patient’s serum sodium level fell further. The patient was then treated for suspected syndrome of inappropriate antidiuretic hormone (SIADH) with a hypertonic saline infusion. The rise in sodium was carefully controlled to avoid rapid overcorrection, which can lead to irreversible neurologic symptoms. Finally, the patient’s sodium level and neurologic status improved.

The clinicians say the case demonstrates the complexity of differentiating between the causes of hyponatremia after head injury. Volume status may be an indicator, they say, but current clinical and laboratory markers of volume status are often limited in accuracy. The hallmark of RSW is volume depletion, whereas diagnosis of SIADH depends on a coexisting euvolemic state (as with the patient).

As many as 10% of victims of traumatic brain injury develop hyponatremia, and it is associated with a worse prognosis, even in mild cases, the clinicians note. Making the right diagnosis is critical—the treatment chosen can easily compromise the outcome. Patients with neurosurgical conditions are often treated with considerable volumes of saline-containing fluid, with consequent dynamic changes in blood and extracellular volumes. Moreover, the patients have elevated levels of adrenergic hormones with their own confounding effects.

In the long term, the patient experienced significant neurologic sequelae, including prolonged posttraumatic amnesia. After extensive rehabilitation he was able to return to the university.

After weeks of speculation, President Donald Trump fired VA Secretary David J. Shulkin, MD, on March 28 and proposed White House physician US Navy RADM Ronny L. Jackson, MD, as his replacement. In another unusual move, President Trump did not ask Deputy Secretary of Veterans Affairs Thomas G. Bowman to manage the agency during the confirmation process, but instead asked Robert Leon Wilkie Jr who was serving as the US Department of Defense Undersecretary of Defense for Personnel and Readiness.

While acknowledging that all cabinet members serve at the pleasure of the President, Shulkin placed the blame for his dismissal squarely on other VA political appointees. “There are many political appointees in the VA that believe that we are moving in the wrong direction or weren’t moving fast enough toward privatizing the VA,” Shulkin told NPR in an early morning interview. “I think that it’s essential for national security and for the country that we honor our commitment by having a strong VA. I was not against reforming VA, but I was against privatization.”

Shulkin was clearly prepared and quick to indentify his oponents in the administration. He wrote a New York Times op-ed that was published just hours after his firing. “Successes within the department have intensified the ambitions of people who want to put VA health care in the hands of the private sector,” Dr. Shulkin wrote. “I believe differences in philosophy deserve robust debate, and solutions should be determined based on the merits of the arguments. The advocates within the administration for privatizing VA health services, however, reject this approach. They saw me as an obstacle to privatization who had to be removed. That is because I am convinced that privatization is a political issue aimed at rewarding select people and companies with profits, even if it undermines care for veterans.”

“As I prepare to leave government,” Shulkin concluded, “I am struck by a recurring thought: It should not be this hard to serve your country.”

Although controversy has swirled around Dr. Shulkin since the release of a VA Inspector General report that was highly critical of a trip to Europe, he dismissed the trip as a cause of his dismissal. According to Shulkin, the White House had refused to allow him to defend himself and point out that the trip was for the White House and the VA. “This was the five allies conference, a trip that the VA secretary has participated in for 40 years with major allies,” he told NPR “The single expenditure spent was on a coach airfare for my wife who was officially invited. Everything was pre-approved by our ethics committee. When the Inspector General didn't like the way that my staff had handled the approval, I wrote a check back to the government.”

Despite the controversy, veteran service organizations (VSOs) and congressional leaders have remained supportive of Dr. Shulkin and skeptical of Dr. Jackson. Most of the VSOs were quick to issue statements. “We are grateful for [Dr. Shulkin’s] efforts to steer VA toward sensible, lasting transformation of veterans health care and hope to see those plans continue moving forward,” said Commander Delphine Metcalf-Foster of Disabled American Veterans in a statement. “While we look forward to learning more about the qualifications and views of the new nominee, we are extremely concerned about the existing leadership vacuum in VA.  At a time of critical negotiations over the future of veterans health care reform, VA today has no Secretary, no Under Secretary of Health or Benefits, and the named Acting Secretary has no background in health care and no apparent experience working in or with the Department.”

In his statement, AMVETS Executive Director Joe Chenelly raised a number of issues that are likely to take center stage in the confirmation hearings, asking “is it appropriate for an active-duty military officer to run a federal agency?” and “with an official bio that does not seem to contain any indication that he’s held a command, is the president’s nominee fully prepared to lead such a massive bureaucracy?” Chenelly added, “I am deeply concerned about the nominee. Veterans’ lives depend on this decision, and the Trump administration needs to substantiate that this active-duty Navy officer is qualified to run a $200 billion bureaucracy, the second largest agency in the government.”

After weeks of speculation, President Donald Trump fired VA Secretary David J. Shulkin, MD, on March 28 and proposed White House physician US Navy RADM Ronny L. Jackson, MD, as his replacement. In another unusual move, President Trump did not ask Deputy Secretary of Veterans Affairs Thomas G. Bowman to manage the agency during the confirmation process, but instead asked Robert Leon Wilkie Jr who was serving as the US Department of Defense Undersecretary of Defense for Personnel and Readiness.

While acknowledging that all cabinet members serve at the pleasure of the President, Shulkin placed the blame for his dismissal squarely on other VA political appointees. “There are many political appointees in the VA that believe that we are moving in the wrong direction or weren’t moving fast enough toward privatizing the VA,” Shulkin told NPR in an early morning interview. “I think that it’s essential for national security and for the country that we honor our commitment by having a strong VA. I was not against reforming VA, but I was against privatization.”

Shulkin was clearly prepared and quick to indentify his oponents in the administration. He wrote a New York Times op-ed that was published just hours after his firing. “Successes within the department have intensified the ambitions of people who want to put VA health care in the hands of the private sector,” Dr. Shulkin wrote. “I believe differences in philosophy deserve robust debate, and solutions should be determined based on the merits of the arguments. The advocates within the administration for privatizing VA health services, however, reject this approach. They saw me as an obstacle to privatization who had to be removed. That is because I am convinced that privatization is a political issue aimed at rewarding select people and companies with profits, even if it undermines care for veterans.”

“As I prepare to leave government,” Shulkin concluded, “I am struck by a recurring thought: It should not be this hard to serve your country.”

Although controversy has swirled around Dr. Shulkin since the release of a VA Inspector General report that was highly critical of a trip to Europe, he dismissed the trip as a cause of his dismissal. According to Shulkin, the White House had refused to allow him to defend himself and point out that the trip was for the White House and the VA. “This was the five allies conference, a trip that the VA secretary has participated in for 40 years with major allies,” he told NPR “The single expenditure spent was on a coach airfare for my wife who was officially invited. Everything was pre-approved by our ethics committee. When the Inspector General didn't like the way that my staff had handled the approval, I wrote a check back to the government.”

Despite the controversy, veteran service organizations (VSOs) and congressional leaders have remained supportive of Dr. Shulkin and skeptical of Dr. Jackson. Most of the VSOs were quick to issue statements. “We are grateful for [Dr. Shulkin’s] efforts to steer VA toward sensible, lasting transformation of veterans health care and hope to see those plans continue moving forward,” said Commander Delphine Metcalf-Foster of Disabled American Veterans in a statement. “While we look forward to learning more about the qualifications and views of the new nominee, we are extremely concerned about the existing leadership vacuum in VA.  At a time of critical negotiations over the future of veterans health care reform, VA today has no Secretary, no Under Secretary of Health or Benefits, and the named Acting Secretary has no background in health care and no apparent experience working in or with the Department.”

In his statement, AMVETS Executive Director Joe Chenelly raised a number of issues that are likely to take center stage in the confirmation hearings, asking “is it appropriate for an active-duty military officer to run a federal agency?” and “with an official bio that does not seem to contain any indication that he’s held a command, is the president’s nominee fully prepared to lead such a massive bureaucracy?” Chenelly added, “I am deeply concerned about the nominee. Veterans’ lives depend on this decision, and the Trump administration needs to substantiate that this active-duty Navy officer is qualified to run a $200 billion bureaucracy, the second largest agency in the government.”

After weeks of speculation, President Donald Trump fired VA Secretary David J. Shulkin, MD, on March 28 and proposed White House physician US Navy RADM Ronny L. Jackson, MD, as his replacement. In another unusual move, President Trump did not ask Deputy Secretary of Veterans Affairs Thomas G. Bowman to manage the agency during the confirmation process, but instead asked Robert Leon Wilkie Jr who was serving as the US Department of Defense Undersecretary of Defense for Personnel and Readiness.

While acknowledging that all cabinet members serve at the pleasure of the President, Shulkin placed the blame for his dismissal squarely on other VA political appointees. “There are many political appointees in the VA that believe that we are moving in the wrong direction or weren’t moving fast enough toward privatizing the VA,” Shulkin told NPR in an early morning interview. “I think that it’s essential for national security and for the country that we honor our commitment by having a strong VA. I was not against reforming VA, but I was against privatization.”

Shulkin was clearly prepared and quick to indentify his oponents in the administration. He wrote a New York Times op-ed that was published just hours after his firing. “Successes within the department have intensified the ambitions of people who want to put VA health care in the hands of the private sector,” Dr. Shulkin wrote. “I believe differences in philosophy deserve robust debate, and solutions should be determined based on the merits of the arguments. The advocates within the administration for privatizing VA health services, however, reject this approach. They saw me as an obstacle to privatization who had to be removed. That is because I am convinced that privatization is a political issue aimed at rewarding select people and companies with profits, even if it undermines care for veterans.”

“As I prepare to leave government,” Shulkin concluded, “I am struck by a recurring thought: It should not be this hard to serve your country.”

Although controversy has swirled around Dr. Shulkin since the release of a VA Inspector General report that was highly critical of a trip to Europe, he dismissed the trip as a cause of his dismissal. According to Shulkin, the White House had refused to allow him to defend himself and point out that the trip was for the White House and the VA. “This was the five allies conference, a trip that the VA secretary has participated in for 40 years with major allies,” he told NPR “The single expenditure spent was on a coach airfare for my wife who was officially invited. Everything was pre-approved by our ethics committee. When the Inspector General didn't like the way that my staff had handled the approval, I wrote a check back to the government.”

Despite the controversy, veteran service organizations (VSOs) and congressional leaders have remained supportive of Dr. Shulkin and skeptical of Dr. Jackson. Most of the VSOs were quick to issue statements. “We are grateful for [Dr. Shulkin’s] efforts to steer VA toward sensible, lasting transformation of veterans health care and hope to see those plans continue moving forward,” said Commander Delphine Metcalf-Foster of Disabled American Veterans in a statement. “While we look forward to learning more about the qualifications and views of the new nominee, we are extremely concerned about the existing leadership vacuum in VA.  At a time of critical negotiations over the future of veterans health care reform, VA today has no Secretary, no Under Secretary of Health or Benefits, and the named Acting Secretary has no background in health care and no apparent experience working in or with the Department.”

In his statement, AMVETS Executive Director Joe Chenelly raised a number of issues that are likely to take center stage in the confirmation hearings, asking “is it appropriate for an active-duty military officer to run a federal agency?” and “with an official bio that does not seem to contain any indication that he’s held a command, is the president’s nominee fully prepared to lead such a massive bureaucracy?” Chenelly added, “I am deeply concerned about the nominee. Veterans’ lives depend on this decision, and the Trump administration needs to substantiate that this active-duty Navy officer is qualified to run a $200 billion bureaucracy, the second largest agency in the government.”