To the Editor:

Dermatomyositis represents a rare idiopathic inflammatory process presenting with cutaneous lesions and muscular weakness. It often represents a paraneoplastic syndrome. We report the case of a 62-year-old man with a history of total-body poikiloderma and a recent diagnosis of chronic lymphocytic leukemia (CLL). Despite lacking typical features of the disease, a diagnosis of dermatomyositis was made. Our patient may represent a distinct poikilodermatous variant of dermatomyositis, sharing the generalized distribution of the erythrodermic subtype.

A 62-year-old man presented with pruritic poikiloderma involving the neck, arms, legs, abdomen, chest, and back of 2 years’ duration (Figure). He also experienced dysphagia and weakness of the legs. The rash was previously treated by other dermatologists with a combination of high-potency topical steroids and topical tacrolimus 0.1% without success. His history was notable for CLL, which had been diagnosed by a dermatologist 6 months prior to the current presentation. Prior to his visit to the dermatologist, the patient had received 6 chemotherapeutic sessions with a combination of rituximab and cyclophosphamide for the treatment of CLL. The rash did not improve with chemotherapy.

Repeat biopsies of affected regions only demonstrated features of mild interface dermatitis. Direct immunofluorescence studies showed scattered colloid body fluorescence for IgM. Because of bilateral weakness of the legs, a muscle biopsy was taken, which demonstrated severe atrophy and interstitial fibrosis, with neurogenic abnormalities detected in areas of lesser atrophy via abnormal muscle fiber–type grouping. Metabolic panel showed elevated muscle enzymes in the blood: creatine kinase, 243 U/L (reference range, 10–225 U/L); serum aldolase, 16 U/L (reference range, ≤8.1 U/L); lactate dehydrogenase, 314 U/L (reference range, 60–200 U/L). An autoimmune panel was negative for Jo-1, Scl-70, U1 ribonucleoprotein, DNA, desmoglein 1 and 3, and antiacetylcholine receptor antibodies. An elevated erythrocyte sedimentation rate was measured at 16 mm/h (reference range, 0–10 mm/h). Given these findings, the lesions were confirmed as a widespread poikilodermatous variant of dermatomyositis.

The patient was placed on a daily 50-mg dose of prednisone, which produced rapid improvement in scaling and erythema. Creatine kinase and serum aldolase levels normalized and motor strength increased. After 1 week the prednisone dosage was reduced to a daily 30-mg dose, and then 20 mg a week later. The skin lesions completely resolved within 4 to 5 months and the patient is currently on a prednisone dose of 5 mg, alternating with 2.5 mg of prednisone and rituximab infusion every 2 months.

Dermatomyositis is a rare entity with an incidence of approximately 0.5 to 1 per 100,000 individuals.¹ It presents with a characteristic rash composed of Gottron papules; pathognomonic flat violaceous papules on the dorsal interphalangeal joints, elbows, or knees; and a heliotrope rash, a violaceous erythema involving the eyelids. Poikiloderma frequently is reported to present in a shawl-like distribution, encompassing the shoulders, arms, and upper back.^1,2 Dermatomyositis of the poikilodermatous type can present in nonphotoexposed areas and photoexposed areas. The unusual feature is the total-body involvement, which is analogous to erythroderma.³

Our case may represent a distinct poikilodermatous manifestation sharing the distribution of the erythrodermic subtype. We believe that the skin lesions may have represented a paraneoplastic event presenting prior to diagnosis with CLL. Dermatomyositis has a strong association with cancer, with patients 3 times more likely to develop internal malignancy.⁴ Association is strongest for non-Hodgkin lymphoma, as well as ovarian, lung, colorectal, pancreatic, and gastric cancer. When associated with malignancy, symptoms of dermatomyositis or myositis typically precede the discovery of malignancy by an average of 1.9 years.⁵ Dermatomyositis has been previously reported to present as a paraneoplastic manifestation of CLL.⁶ One case has been reported of a patient with CLL who developed leukemia cutis presenting with poikiloderma in the characteristic dermatomyositis shawl-like distribution.⁷ The lack of dermal infiltration with leukemic cells in our patient, however, makes a paraneoplastic etiology much more likely.

Our patient’s rash did not initially improve with treatment of CLL, but dermatomyositis associated with hematological malignancy may precede, occur simultaneously, or follow the diagnosis of malignancy.⁸ Additionally, symptoms of dermatomyositis do not always parallel the course of hematological malignancy outcome. However, rituximab has been used as a treatment of dermatomyositis and may have contributed some synergistic effect in combination with prednisone in our patient.⁹

To the Editor:

Dermatomyositis represents a rare idiopathic inflammatory process presenting with cutaneous lesions and muscular weakness. It often represents a paraneoplastic syndrome. We report the case of a 62-year-old man with a history of total-body poikiloderma and a recent diagnosis of chronic lymphocytic leukemia (CLL). Despite lacking typical features of the disease, a diagnosis of dermatomyositis was made. Our patient may represent a distinct poikilodermatous variant of dermatomyositis, sharing the generalized distribution of the erythrodermic subtype.

A 62-year-old man presented with pruritic poikiloderma involving the neck, arms, legs, abdomen, chest, and back of 2 years’ duration (Figure). He also experienced dysphagia and weakness of the legs. The rash was previously treated by other dermatologists with a combination of high-potency topical steroids and topical tacrolimus 0.1% without success. His history was notable for CLL, which had been diagnosed by a dermatologist 6 months prior to the current presentation. Prior to his visit to the dermatologist, the patient had received 6 chemotherapeutic sessions with a combination of rituximab and cyclophosphamide for the treatment of CLL. The rash did not improve with chemotherapy.

Repeat biopsies of affected regions only demonstrated features of mild interface dermatitis. Direct immunofluorescence studies showed scattered colloid body fluorescence for IgM. Because of bilateral weakness of the legs, a muscle biopsy was taken, which demonstrated severe atrophy and interstitial fibrosis, with neurogenic abnormalities detected in areas of lesser atrophy via abnormal muscle fiber–type grouping. Metabolic panel showed elevated muscle enzymes in the blood: creatine kinase, 243 U/L (reference range, 10–225 U/L); serum aldolase, 16 U/L (reference range, ≤8.1 U/L); lactate dehydrogenase, 314 U/L (reference range, 60–200 U/L). An autoimmune panel was negative for Jo-1, Scl-70, U1 ribonucleoprotein, DNA, desmoglein 1 and 3, and antiacetylcholine receptor antibodies. An elevated erythrocyte sedimentation rate was measured at 16 mm/h (reference range, 0–10 mm/h). Given these findings, the lesions were confirmed as a widespread poikilodermatous variant of dermatomyositis.

The patient was placed on a daily 50-mg dose of prednisone, which produced rapid improvement in scaling and erythema. Creatine kinase and serum aldolase levels normalized and motor strength increased. After 1 week the prednisone dosage was reduced to a daily 30-mg dose, and then 20 mg a week later. The skin lesions completely resolved within 4 to 5 months and the patient is currently on a prednisone dose of 5 mg, alternating with 2.5 mg of prednisone and rituximab infusion every 2 months.

Dermatomyositis is a rare entity with an incidence of approximately 0.5 to 1 per 100,000 individuals.¹ It presents with a characteristic rash composed of Gottron papules; pathognomonic flat violaceous papules on the dorsal interphalangeal joints, elbows, or knees; and a heliotrope rash, a violaceous erythema involving the eyelids. Poikiloderma frequently is reported to present in a shawl-like distribution, encompassing the shoulders, arms, and upper back.^1,2 Dermatomyositis of the poikilodermatous type can present in nonphotoexposed areas and photoexposed areas. The unusual feature is the total-body involvement, which is analogous to erythroderma.³

Our case may represent a distinct poikilodermatous manifestation sharing the distribution of the erythrodermic subtype. We believe that the skin lesions may have represented a paraneoplastic event presenting prior to diagnosis with CLL. Dermatomyositis has a strong association with cancer, with patients 3 times more likely to develop internal malignancy.⁴ Association is strongest for non-Hodgkin lymphoma, as well as ovarian, lung, colorectal, pancreatic, and gastric cancer. When associated with malignancy, symptoms of dermatomyositis or myositis typically precede the discovery of malignancy by an average of 1.9 years.⁵ Dermatomyositis has been previously reported to present as a paraneoplastic manifestation of CLL.⁶ One case has been reported of a patient with CLL who developed leukemia cutis presenting with poikiloderma in the characteristic dermatomyositis shawl-like distribution.⁷ The lack of dermal infiltration with leukemic cells in our patient, however, makes a paraneoplastic etiology much more likely.

Our patient’s rash did not initially improve with treatment of CLL, but dermatomyositis associated with hematological malignancy may precede, occur simultaneously, or follow the diagnosis of malignancy.⁸ Additionally, symptoms of dermatomyositis do not always parallel the course of hematological malignancy outcome. However, rituximab has been used as a treatment of dermatomyositis and may have contributed some synergistic effect in combination with prednisone in our patient.⁹

To the Editor:

Dermatomyositis represents a rare idiopathic inflammatory process presenting with cutaneous lesions and muscular weakness. It often represents a paraneoplastic syndrome. We report the case of a 62-year-old man with a history of total-body poikiloderma and a recent diagnosis of chronic lymphocytic leukemia (CLL). Despite lacking typical features of the disease, a diagnosis of dermatomyositis was made. Our patient may represent a distinct poikilodermatous variant of dermatomyositis, sharing the generalized distribution of the erythrodermic subtype.

A 62-year-old man presented with pruritic poikiloderma involving the neck, arms, legs, abdomen, chest, and back of 2 years’ duration (Figure). He also experienced dysphagia and weakness of the legs. The rash was previously treated by other dermatologists with a combination of high-potency topical steroids and topical tacrolimus 0.1% without success. His history was notable for CLL, which had been diagnosed by a dermatologist 6 months prior to the current presentation. Prior to his visit to the dermatologist, the patient had received 6 chemotherapeutic sessions with a combination of rituximab and cyclophosphamide for the treatment of CLL. The rash did not improve with chemotherapy.

Repeat biopsies of affected regions only demonstrated features of mild interface dermatitis. Direct immunofluorescence studies showed scattered colloid body fluorescence for IgM. Because of bilateral weakness of the legs, a muscle biopsy was taken, which demonstrated severe atrophy and interstitial fibrosis, with neurogenic abnormalities detected in areas of lesser atrophy via abnormal muscle fiber–type grouping. Metabolic panel showed elevated muscle enzymes in the blood: creatine kinase, 243 U/L (reference range, 10–225 U/L); serum aldolase, 16 U/L (reference range, ≤8.1 U/L); lactate dehydrogenase, 314 U/L (reference range, 60–200 U/L). An autoimmune panel was negative for Jo-1, Scl-70, U1 ribonucleoprotein, DNA, desmoglein 1 and 3, and antiacetylcholine receptor antibodies. An elevated erythrocyte sedimentation rate was measured at 16 mm/h (reference range, 0–10 mm/h). Given these findings, the lesions were confirmed as a widespread poikilodermatous variant of dermatomyositis.

The patient was placed on a daily 50-mg dose of prednisone, which produced rapid improvement in scaling and erythema. Creatine kinase and serum aldolase levels normalized and motor strength increased. After 1 week the prednisone dosage was reduced to a daily 30-mg dose, and then 20 mg a week later. The skin lesions completely resolved within 4 to 5 months and the patient is currently on a prednisone dose of 5 mg, alternating with 2.5 mg of prednisone and rituximab infusion every 2 months.

Dermatomyositis is a rare entity with an incidence of approximately 0.5 to 1 per 100,000 individuals.¹ It presents with a characteristic rash composed of Gottron papules; pathognomonic flat violaceous papules on the dorsal interphalangeal joints, elbows, or knees; and a heliotrope rash, a violaceous erythema involving the eyelids. Poikiloderma frequently is reported to present in a shawl-like distribution, encompassing the shoulders, arms, and upper back.^1,2 Dermatomyositis of the poikilodermatous type can present in nonphotoexposed areas and photoexposed areas. The unusual feature is the total-body involvement, which is analogous to erythroderma.³

Our case may represent a distinct poikilodermatous manifestation sharing the distribution of the erythrodermic subtype. We believe that the skin lesions may have represented a paraneoplastic event presenting prior to diagnosis with CLL. Dermatomyositis has a strong association with cancer, with patients 3 times more likely to develop internal malignancy.⁴ Association is strongest for non-Hodgkin lymphoma, as well as ovarian, lung, colorectal, pancreatic, and gastric cancer. When associated with malignancy, symptoms of dermatomyositis or myositis typically precede the discovery of malignancy by an average of 1.9 years.⁵ Dermatomyositis has been previously reported to present as a paraneoplastic manifestation of CLL.⁶ One case has been reported of a patient with CLL who developed leukemia cutis presenting with poikiloderma in the characteristic dermatomyositis shawl-like distribution.⁷ The lack of dermal infiltration with leukemic cells in our patient, however, makes a paraneoplastic etiology much more likely.

Our patient’s rash did not initially improve with treatment of CLL, but dermatomyositis associated with hematological malignancy may precede, occur simultaneously, or follow the diagnosis of malignancy.⁸ Additionally, symptoms of dermatomyositis do not always parallel the course of hematological malignancy outcome. However, rituximab has been used as a treatment of dermatomyositis and may have contributed some synergistic effect in combination with prednisone in our patient.⁹

Japan has a universal health care system with low copays and short wait times for appointments, including those with specialists. Yet patient satisfaction scores are low compared with those of other countries. Researchers from Juntendo Urayasu Hospital, a university hospital in a Tokyo suburb, conducted a study of 214 patients with breast cancer to find out which aspects of radiation oncology care might affect patient satisfaction. The survey included questions about overall treatment, time from diagnosis to treatment start, wait times in the hospital, and length of consultations.

Related: Improving the Performance of the Chemotherapy Clinic at the North Florida/South Georgia Veterans Health System

In general, levels of satisfaction were high. However, wait time was significantly negatively associated with both overall satisfaction and satisfaction with the radiation oncologist. Wait time was just under an hour for an average 11-minute consultation. Although this was longer than the “notorious” Japanese situation of a “3 hours wait and 3 minutes consultation,” the researchers say, “We expect that an international audience will appreciate that even 11 minutes is an exceptionally short duration for a consultation visit with a specialist in radiation oncology.”

They note, though, a reasonable caveat. Anyone can walk into their hospital and, for an additional fee, see a specialist on the day they want, which can lead to extended wait times from sheer congestion. Their hospital’s chief breast cancer surgeon sees 60 to 70 patients a day; the radiation oncologist treats 500 to 600 patients a year without resident or trainee support. This situation is typical of Japanese university hospitals, the researchers add.

Related: Breast Cancer Treatment Among Rural and Urban Women at the Veterans Health Administration

Importantly, for Japanese patients, the researchers also included questions to measure patients’ opinions about sharing how they felt with their physicians. The level of sharing correlated with satisfaction, but the researchers point out that in Japan sharing feelings remains “challenging.” Their findings suggest, they say, that if this were improved, patients’ satisfaction might increase.

Japan has a universal health care system with low copays and short wait times for appointments, including those with specialists. Yet patient satisfaction scores are low compared with those of other countries. Researchers from Juntendo Urayasu Hospital, a university hospital in a Tokyo suburb, conducted a study of 214 patients with breast cancer to find out which aspects of radiation oncology care might affect patient satisfaction. The survey included questions about overall treatment, time from diagnosis to treatment start, wait times in the hospital, and length of consultations.

Related: Improving the Performance of the Chemotherapy Clinic at the North Florida/South Georgia Veterans Health System

In general, levels of satisfaction were high. However, wait time was significantly negatively associated with both overall satisfaction and satisfaction with the radiation oncologist. Wait time was just under an hour for an average 11-minute consultation. Although this was longer than the “notorious” Japanese situation of a “3 hours wait and 3 minutes consultation,” the researchers say, “We expect that an international audience will appreciate that even 11 minutes is an exceptionally short duration for a consultation visit with a specialist in radiation oncology.”

They note, though, a reasonable caveat. Anyone can walk into their hospital and, for an additional fee, see a specialist on the day they want, which can lead to extended wait times from sheer congestion. Their hospital’s chief breast cancer surgeon sees 60 to 70 patients a day; the radiation oncologist treats 500 to 600 patients a year without resident or trainee support. This situation is typical of Japanese university hospitals, the researchers add.

Related: Breast Cancer Treatment Among Rural and Urban Women at the Veterans Health Administration

Importantly, for Japanese patients, the researchers also included questions to measure patients’ opinions about sharing how they felt with their physicians. The level of sharing correlated with satisfaction, but the researchers point out that in Japan sharing feelings remains “challenging.” Their findings suggest, they say, that if this were improved, patients’ satisfaction might increase.

Japan has a universal health care system with low copays and short wait times for appointments, including those with specialists. Yet patient satisfaction scores are low compared with those of other countries. Researchers from Juntendo Urayasu Hospital, a university hospital in a Tokyo suburb, conducted a study of 214 patients with breast cancer to find out which aspects of radiation oncology care might affect patient satisfaction. The survey included questions about overall treatment, time from diagnosis to treatment start, wait times in the hospital, and length of consultations.

Related: Improving the Performance of the Chemotherapy Clinic at the North Florida/South Georgia Veterans Health System

In general, levels of satisfaction were high. However, wait time was significantly negatively associated with both overall satisfaction and satisfaction with the radiation oncologist. Wait time was just under an hour for an average 11-minute consultation. Although this was longer than the “notorious” Japanese situation of a “3 hours wait and 3 minutes consultation,” the researchers say, “We expect that an international audience will appreciate that even 11 minutes is an exceptionally short duration for a consultation visit with a specialist in radiation oncology.”

They note, though, a reasonable caveat. Anyone can walk into their hospital and, for an additional fee, see a specialist on the day they want, which can lead to extended wait times from sheer congestion. Their hospital’s chief breast cancer surgeon sees 60 to 70 patients a day; the radiation oncologist treats 500 to 600 patients a year without resident or trainee support. This situation is typical of Japanese university hospitals, the researchers add.

Related: Breast Cancer Treatment Among Rural and Urban Women at the Veterans Health Administration

Importantly, for Japanese patients, the researchers also included questions to measure patients’ opinions about sharing how they felt with their physicians. The level of sharing correlated with satisfaction, but the researchers point out that in Japan sharing feelings remains “challenging.” Their findings suggest, they say, that if this were improved, patients’ satisfaction might increase.

LAS VEGAS – Intrathecal hydromorphone, administered alone or with lidocaine, effectively controlled pain and decreased postoperative opioid use after colorectal surgery in a retrospective study.

The technique was so effective that 28% of patients required no postoperative opioids at all, Amit Merchea, MD, said at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.

The intrathecal analgesic was part of an enhanced recovery pathway (ERP) for patients undergoing elective colorectal surgery at the Mayo Clinic, Jacksonville, Fla., where Dr. Merchea practices colorectal surgery.

©Dmitrii Kotin/Thinkstock.com

[email protected]

On Twitter @Alz_Gal

LAS VEGAS – Intrathecal hydromorphone, administered alone or with lidocaine, effectively controlled pain and decreased postoperative opioid use after colorectal surgery in a retrospective study.

The technique was so effective that 28% of patients required no postoperative opioids at all, Amit Merchea, MD, said at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.

The intrathecal analgesic was part of an enhanced recovery pathway (ERP) for patients undergoing elective colorectal surgery at the Mayo Clinic, Jacksonville, Fla., where Dr. Merchea practices colorectal surgery.

©Dmitrii Kotin/Thinkstock.com

[email protected]

On Twitter @Alz_Gal

LAS VEGAS – Intrathecal hydromorphone, administered alone or with lidocaine, effectively controlled pain and decreased postoperative opioid use after colorectal surgery in a retrospective study.

The technique was so effective that 28% of patients required no postoperative opioids at all, Amit Merchea, MD, said at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.

The intrathecal analgesic was part of an enhanced recovery pathway (ERP) for patients undergoing elective colorectal surgery at the Mayo Clinic, Jacksonville, Fla., where Dr. Merchea practices colorectal surgery.

©Dmitrii Kotin/Thinkstock.com

[email protected]

On Twitter @Alz_Gal

I’m sure there are folks here in town who wondered how I could keep up a professional pace that often included being on call 2 nights a week and working every third weekend. Even when I was in my early 50s, people asked me if I was getting ready to retire. I hope it wasn’t because I appeared unhappy or looked 15 years older than I was. I suspect that some parents who didn’t know me well predicted that my career would have ended far short of 40 years.

One of the secrets of what appeared to be my superhuman stamina was that almost every day at noon I was out to lunch. That doesn’t mean that I always took time to eat lunch. In fact, I must admit that more often than not my midday diet consisted of several handfuls of cashews or an energy bar eaten on the fly.

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.”

I’m sure there are folks here in town who wondered how I could keep up a professional pace that often included being on call 2 nights a week and working every third weekend. Even when I was in my early 50s, people asked me if I was getting ready to retire. I hope it wasn’t because I appeared unhappy or looked 15 years older than I was. I suspect that some parents who didn’t know me well predicted that my career would have ended far short of 40 years.

One of the secrets of what appeared to be my superhuman stamina was that almost every day at noon I was out to lunch. That doesn’t mean that I always took time to eat lunch. In fact, I must admit that more often than not my midday diet consisted of several handfuls of cashews or an energy bar eaten on the fly.

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.”

I’m sure there are folks here in town who wondered how I could keep up a professional pace that often included being on call 2 nights a week and working every third weekend. Even when I was in my early 50s, people asked me if I was getting ready to retire. I hope it wasn’t because I appeared unhappy or looked 15 years older than I was. I suspect that some parents who didn’t know me well predicted that my career would have ended far short of 40 years.

One of the secrets of what appeared to be my superhuman stamina was that almost every day at noon I was out to lunch. That doesn’t mean that I always took time to eat lunch. In fact, I must admit that more often than not my midday diet consisted of several handfuls of cashews or an energy bar eaten on the fly.

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.”

SAN DIEGO – A “mechanism-based” combination of ibrutinib and palbociclib was reasonably well tolerated and induced complete responses in 44% of patients with previously treated mantle cell lymphoma, Peter Martin, MD, reported at the annual meeting of the American Society of Hematology.

Fully 67% of patients remained alive and progression-free after a median of 11 months of follow-up, and no responders progressed during this phase I trial, added Dr. Martin of Weill Cornell Medical College in New York. These rates “appear better than those reported in studies of single-agent ibrutinib, although the number of patients was very small,” he acknowledged. Most patients tolerated therapy, although 25% developed dose-limiting toxicities or stopped treatment because of adverse effects. Based on these results, the investigators are studying biomarkers for resistance and are planning a phase II, multicenter trial to evaluate time to progression.

Single-agent ibrutinib (Imbruvica) has shown promise in mantle cell lymphoma, but treatment failure affects about half of patients within 1 year, Dr. Martin noted. The CDK4/6 inhibitor palbociclib (Ibrance) induces prolonged arrest early in the G1 phase of the cell cycle, which overcame ibrutinib resistance in mantle cell lymphoma cell lines in a prior study (Cancer Discov. 2014;4[9]:1022-35).

To test the maximum tolerated dose of combination therapy, Dr. Martin and his associates enrolled 20 adults with previously treated mantle cell lymphoma who were naive to ibrutinib and CD4/6 inhibitors. The patients had received a median of one and up to five prior lines of therapy, and six (30%) were refractory to their most recent therapy. They received ibrutinib daily and palbociclib on the first 21 days of each 28-day treatment cycle. Dosing began at one of five levels, ranging from 280 mg ibrutinib/75 mg palbociclib to 560 mg ibrutinib/125 mg palbociclib. Doses were escalated based on a standard phase I 3+3 design.

Among 18 patients evaluated, 12 (67%) responded to treatment, and 8 (44%) had a complete response. Median time to complete response was three cycles. The most common grade 1-2 adverse events were diarrhea, fatigue, rash, and bruising. Three patients (15%) developed dose-limiting toxicities. These included one case of grade 4 thrombocytopenia at 420 mg ibrutinib/100 mg palbociclib and two cases of grade 3 rash at 560 mg ibrutinib/125 mg palbociclib. The grade 3 rashes led to dose reductions, and six patients needed dose interruptions. Also, four patients stopped treatment because of disease progression, two did so because of elevated liver enzymes or prolonged cytopenia, and one did so to undergo allogeneic stem cell transplantation.

The National Cancer Institute sponsored the study. Dr. Martin disclosed ties to Janssen, which makes ibrutinib, and to Celgene, Gilead, Novartis, Acerta, and Teva. Senior author John P. Leonard, MD, and one of 10 coinvestigators disclosed ties to several pharmaceutical companies.

SAN DIEGO – A “mechanism-based” combination of ibrutinib and palbociclib was reasonably well tolerated and induced complete responses in 44% of patients with previously treated mantle cell lymphoma, Peter Martin, MD, reported at the annual meeting of the American Society of Hematology.

Fully 67% of patients remained alive and progression-free after a median of 11 months of follow-up, and no responders progressed during this phase I trial, added Dr. Martin of Weill Cornell Medical College in New York. These rates “appear better than those reported in studies of single-agent ibrutinib, although the number of patients was very small,” he acknowledged. Most patients tolerated therapy, although 25% developed dose-limiting toxicities or stopped treatment because of adverse effects. Based on these results, the investigators are studying biomarkers for resistance and are planning a phase II, multicenter trial to evaluate time to progression.

Single-agent ibrutinib (Imbruvica) has shown promise in mantle cell lymphoma, but treatment failure affects about half of patients within 1 year, Dr. Martin noted. The CDK4/6 inhibitor palbociclib (Ibrance) induces prolonged arrest early in the G1 phase of the cell cycle, which overcame ibrutinib resistance in mantle cell lymphoma cell lines in a prior study (Cancer Discov. 2014;4[9]:1022-35).

To test the maximum tolerated dose of combination therapy, Dr. Martin and his associates enrolled 20 adults with previously treated mantle cell lymphoma who were naive to ibrutinib and CD4/6 inhibitors. The patients had received a median of one and up to five prior lines of therapy, and six (30%) were refractory to their most recent therapy. They received ibrutinib daily and palbociclib on the first 21 days of each 28-day treatment cycle. Dosing began at one of five levels, ranging from 280 mg ibrutinib/75 mg palbociclib to 560 mg ibrutinib/125 mg palbociclib. Doses were escalated based on a standard phase I 3+3 design.

Among 18 patients evaluated, 12 (67%) responded to treatment, and 8 (44%) had a complete response. Median time to complete response was three cycles. The most common grade 1-2 adverse events were diarrhea, fatigue, rash, and bruising. Three patients (15%) developed dose-limiting toxicities. These included one case of grade 4 thrombocytopenia at 420 mg ibrutinib/100 mg palbociclib and two cases of grade 3 rash at 560 mg ibrutinib/125 mg palbociclib. The grade 3 rashes led to dose reductions, and six patients needed dose interruptions. Also, four patients stopped treatment because of disease progression, two did so because of elevated liver enzymes or prolonged cytopenia, and one did so to undergo allogeneic stem cell transplantation.

The National Cancer Institute sponsored the study. Dr. Martin disclosed ties to Janssen, which makes ibrutinib, and to Celgene, Gilead, Novartis, Acerta, and Teva. Senior author John P. Leonard, MD, and one of 10 coinvestigators disclosed ties to several pharmaceutical companies.

SAN DIEGO – A “mechanism-based” combination of ibrutinib and palbociclib was reasonably well tolerated and induced complete responses in 44% of patients with previously treated mantle cell lymphoma, Peter Martin, MD, reported at the annual meeting of the American Society of Hematology.

Fully 67% of patients remained alive and progression-free after a median of 11 months of follow-up, and no responders progressed during this phase I trial, added Dr. Martin of Weill Cornell Medical College in New York. These rates “appear better than those reported in studies of single-agent ibrutinib, although the number of patients was very small,” he acknowledged. Most patients tolerated therapy, although 25% developed dose-limiting toxicities or stopped treatment because of adverse effects. Based on these results, the investigators are studying biomarkers for resistance and are planning a phase II, multicenter trial to evaluate time to progression.

Single-agent ibrutinib (Imbruvica) has shown promise in mantle cell lymphoma, but treatment failure affects about half of patients within 1 year, Dr. Martin noted. The CDK4/6 inhibitor palbociclib (Ibrance) induces prolonged arrest early in the G1 phase of the cell cycle, which overcame ibrutinib resistance in mantle cell lymphoma cell lines in a prior study (Cancer Discov. 2014;4[9]:1022-35).

To test the maximum tolerated dose of combination therapy, Dr. Martin and his associates enrolled 20 adults with previously treated mantle cell lymphoma who were naive to ibrutinib and CD4/6 inhibitors. The patients had received a median of one and up to five prior lines of therapy, and six (30%) were refractory to their most recent therapy. They received ibrutinib daily and palbociclib on the first 21 days of each 28-day treatment cycle. Dosing began at one of five levels, ranging from 280 mg ibrutinib/75 mg palbociclib to 560 mg ibrutinib/125 mg palbociclib. Doses were escalated based on a standard phase I 3+3 design.

Among 18 patients evaluated, 12 (67%) responded to treatment, and 8 (44%) had a complete response. Median time to complete response was three cycles. The most common grade 1-2 adverse events were diarrhea, fatigue, rash, and bruising. Three patients (15%) developed dose-limiting toxicities. These included one case of grade 4 thrombocytopenia at 420 mg ibrutinib/100 mg palbociclib and two cases of grade 3 rash at 560 mg ibrutinib/125 mg palbociclib. The grade 3 rashes led to dose reductions, and six patients needed dose interruptions. Also, four patients stopped treatment because of disease progression, two did so because of elevated liver enzymes or prolonged cytopenia, and one did so to undergo allogeneic stem cell transplantation.

The National Cancer Institute sponsored the study. Dr. Martin disclosed ties to Janssen, which makes ibrutinib, and to Celgene, Gilead, Novartis, Acerta, and Teva. Senior author John P. Leonard, MD, and one of 10 coinvestigators disclosed ties to several pharmaceutical companies.

Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the 3 years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Rep. Price (Ga.) made dozens of health industry stock trades during a 3-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives. The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Rep. Price, who is a retired orthopedic surgeon, was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought. But ethics experts say Rep. Price’s personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

“He should have known better,” Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Rep. Price’s conduct during the SEC inquiry.

As Rep. Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Rep. Price engaged in insider trading with some of his trades in health care companies. Rep. Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC’s inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump’s inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records. No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter’s lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Rep. Price’s volume of stock trades during the SEC inquiry as “brazen,” given the congressman’s access to nonpublic information affecting the companies’ fortunes.

“The public is seeing this and they really don’t like it,” said Holman, whose watchdog group recently filed complaints about Rep. Price’s stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Rep. Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Rep. Price’s brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

“To the best of my knowledge, I have not undertaken such actions,” he wrote in response to finance committee questions. “I have abided by and adhered to all ethics and conflict of interest rules applicable to me.”

An analysis of Rep. Price’s trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the first year Rep. Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a “60 Minutes” investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his 1-year break in health care trades, Rep. Price resumed investing in health care companies.

Along with investments in technology, financial services, and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns, and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Rep. Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Rep. Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen’s stock price had steadily climbed out of a recession-level slump, but Rep. Price’s sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry. Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Rep. Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would “disadvantage vulnerable beneficiaries with multiple chronic conditions.”

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a “flash” report to 200 clients that touched off a surge of trading.

The analyst’s report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner’s confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak’s source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter as well.

As the case unfolded, Rep. Price bought more health care-related stocks, according to his financial disclosures. He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins’ disclosures. An HHS spokesman said Monday that Rep. Price held three broker-directed accounts.

Ethics experts have said that Rep. Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Rep. Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drug maker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Rep. Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor’s offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge’s ruling that it should comply with the SEC subpoena.

Rep. Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Biogen, Bristol-Myers Squibb, Eli Lilly, and Pfizer. He also bought stock in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

“You’re asking for trouble if you have access to nonpublic information about the health care industry and you’re buying and selling health care stocks,” Painter said.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the 3 years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Rep. Price (Ga.) made dozens of health industry stock trades during a 3-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives. The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Rep. Price, who is a retired orthopedic surgeon, was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought. But ethics experts say Rep. Price’s personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

“He should have known better,” Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Rep. Price’s conduct during the SEC inquiry.

As Rep. Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Rep. Price engaged in insider trading with some of his trades in health care companies. Rep. Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC’s inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump’s inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records. No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter’s lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Rep. Price’s volume of stock trades during the SEC inquiry as “brazen,” given the congressman’s access to nonpublic information affecting the companies’ fortunes.

“The public is seeing this and they really don’t like it,” said Holman, whose watchdog group recently filed complaints about Rep. Price’s stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Rep. Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Rep. Price’s brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

“To the best of my knowledge, I have not undertaken such actions,” he wrote in response to finance committee questions. “I have abided by and adhered to all ethics and conflict of interest rules applicable to me.”

An analysis of Rep. Price’s trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the first year Rep. Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a “60 Minutes” investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his 1-year break in health care trades, Rep. Price resumed investing in health care companies.

Along with investments in technology, financial services, and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns, and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Rep. Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Rep. Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen’s stock price had steadily climbed out of a recession-level slump, but Rep. Price’s sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry. Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Rep. Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would “disadvantage vulnerable beneficiaries with multiple chronic conditions.”

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a “flash” report to 200 clients that touched off a surge of trading.

The analyst’s report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner’s confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak’s source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter as well.

As the case unfolded, Rep. Price bought more health care-related stocks, according to his financial disclosures. He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins’ disclosures. An HHS spokesman said Monday that Rep. Price held three broker-directed accounts.

Ethics experts have said that Rep. Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Rep. Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drug maker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Rep. Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor’s offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge’s ruling that it should comply with the SEC subpoena.

Rep. Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Biogen, Bristol-Myers Squibb, Eli Lilly, and Pfizer. He also bought stock in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

“You’re asking for trouble if you have access to nonpublic information about the health care industry and you’re buying and selling health care stocks,” Painter said.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the 3 years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Rep. Price (Ga.) made dozens of health industry stock trades during a 3-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives. The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Rep. Price, who is a retired orthopedic surgeon, was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought. But ethics experts say Rep. Price’s personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

“He should have known better,” Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Rep. Price’s conduct during the SEC inquiry.

As Rep. Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Rep. Price engaged in insider trading with some of his trades in health care companies. Rep. Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC’s inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump’s inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records. No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter’s lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Rep. Price’s volume of stock trades during the SEC inquiry as “brazen,” given the congressman’s access to nonpublic information affecting the companies’ fortunes.

“The public is seeing this and they really don’t like it,” said Holman, whose watchdog group recently filed complaints about Rep. Price’s stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Rep. Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Rep. Price’s brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

“To the best of my knowledge, I have not undertaken such actions,” he wrote in response to finance committee questions. “I have abided by and adhered to all ethics and conflict of interest rules applicable to me.”

An analysis of Rep. Price’s trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the first year Rep. Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a “60 Minutes” investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his 1-year break in health care trades, Rep. Price resumed investing in health care companies.

Along with investments in technology, financial services, and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns, and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Rep. Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Rep. Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen’s stock price had steadily climbed out of a recession-level slump, but Rep. Price’s sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry. Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Rep. Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would “disadvantage vulnerable beneficiaries with multiple chronic conditions.”

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a “flash” report to 200 clients that touched off a surge of trading.

The analyst’s report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner’s confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak’s source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter as well.

As the case unfolded, Rep. Price bought more health care-related stocks, according to his financial disclosures. He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins’ disclosures. An HHS spokesman said Monday that Rep. Price held three broker-directed accounts.

Ethics experts have said that Rep. Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Rep. Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drug maker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Rep. Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor’s offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge’s ruling that it should comply with the SEC subpoena.

Rep. Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Biogen, Bristol-Myers Squibb, Eli Lilly, and Pfizer. He also bought stock in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

“You’re asking for trouble if you have access to nonpublic information about the health care industry and you’re buying and selling health care stocks,” Painter said.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Younger adults who have any calcium deposited in their coronary arteries, even a small amount, are at increased risk for adverse coronary heart disease (CHD) outcomes and death, finds an analysis of the Coronary Artery Risk Development in Young Adults (CARDIA) Study.

There’s no evidence, however, that treating such patients would make a difference in outcomes, John Jeffrey Carr, MD, reported in JAMA Cardiology on Feb. 8.

In the prospective, community-based, cohort study, 5,115 black and white adults underwent coronary computed tomographic (CT) imaging between the ages of 32 and 46 years, and had a mean follow-up of 12.5 years.

Compared with counterparts not having any coronary artery calcium (CAC), those having at least some had a 5.0-fold increased risk of CHD events and a 1.6-fold increased risk of death (JAMA Cardiol. 2017 Feb 8; doi: 10.1001/jamacardio.2016.5493).

Estimates suggested that identification of individuals at elevated risk for developing CAC could inform a selective CT screening strategy whereby the number of younger adults screened could be reduced by half, and the number needing to be imaged to find one person with CAC could be reduced from 3.5 to 2.2.

“The finding that CAC present by ages 32-46 years is associated with increased risk of premature CHD and death emphasizes the need for reduction of risk factors and primordial prevention beginning in early life,” wrote Dr. Carr, professor radiology at Vanderbilt University in Nashville, Tenn.

“Whether any kind of general screening for CAC is warranted needs further study, although we suggest that a strategy in which all individuals aged 32 to 46 years are screened is not indicated. Rather, a more targeted approach based on measuring risk factors in early adult life to predict individuals at high risk for developing CAC in whom the CT scan would have the greatest value can be considered,” they propose.
 

Study details

Participants were recruited to CARDIA when aged 18-30 years, and they underwent CAC measurement at 15, 20, and 25 years after recruitment. Incident events were ascertained starting from the time of the year-15 scan.

At that year-15 scan, 10.2% of participants were found to have CAC. The geometric mean Agatston score was 21.6.

In adjusted analyses, participants with any CAC had sharply higher risks of CHD events (hazard ratio, 5.0), as well as cardiovascular disease events (HR, 3.0). The risk of CHD events increased with CAC score, with hazard ratios of 2.6, 5.8, and 9.8 for individuals with scores of 1-19, 20-99, and 100 or more, respectively.

In addition, participants with any CAC had an elevated adjusted risk of all-cause mortality (HR, 1.6). This risk similarly rose with score but was significant for those having a score of 100 or greater only (hazard ratio, 3.7); the large majority of deaths in this group were deemed to be from CHD events.

The model that the investigators developed predicted the probability of CAC by ages 32-56 years based on risk factors assessed 7 years apart, between the ages of 18 and 38 years.

When stratified by this model, 4.2% of study participants falling into the lowest-risk decile had CAC, compared with 67.8% of those falling into the highest-risk decile.

Analyses suggested that if screening were restricted to those participants having an above-median risk score, fully 77.3% of all those with coronary calcium and 95.5% of all those with CHD events would be identified. Moreover, these yields would be obtained while reducing the number of individuals recommended to be screened by 50.0%.

Younger adults who have any calcium deposited in their coronary arteries, even a small amount, are at increased risk for adverse coronary heart disease (CHD) outcomes and death, finds an analysis of the Coronary Artery Risk Development in Young Adults (CARDIA) Study.

There’s no evidence, however, that treating such patients would make a difference in outcomes, John Jeffrey Carr, MD, reported in JAMA Cardiology on Feb. 8.

In the prospective, community-based, cohort study, 5,115 black and white adults underwent coronary computed tomographic (CT) imaging between the ages of 32 and 46 years, and had a mean follow-up of 12.5 years.

Compared with counterparts not having any coronary artery calcium (CAC), those having at least some had a 5.0-fold increased risk of CHD events and a 1.6-fold increased risk of death (JAMA Cardiol. 2017 Feb 8; doi: 10.1001/jamacardio.2016.5493).

Estimates suggested that identification of individuals at elevated risk for developing CAC could inform a selective CT screening strategy whereby the number of younger adults screened could be reduced by half, and the number needing to be imaged to find one person with CAC could be reduced from 3.5 to 2.2.

“The finding that CAC present by ages 32-46 years is associated with increased risk of premature CHD and death emphasizes the need for reduction of risk factors and primordial prevention beginning in early life,” wrote Dr. Carr, professor radiology at Vanderbilt University in Nashville, Tenn.

“Whether any kind of general screening for CAC is warranted needs further study, although we suggest that a strategy in which all individuals aged 32 to 46 years are screened is not indicated. Rather, a more targeted approach based on measuring risk factors in early adult life to predict individuals at high risk for developing CAC in whom the CT scan would have the greatest value can be considered,” they propose.
 

Study details

Participants were recruited to CARDIA when aged 18-30 years, and they underwent CAC measurement at 15, 20, and 25 years after recruitment. Incident events were ascertained starting from the time of the year-15 scan.

At that year-15 scan, 10.2% of participants were found to have CAC. The geometric mean Agatston score was 21.6.

In adjusted analyses, participants with any CAC had sharply higher risks of CHD events (hazard ratio, 5.0), as well as cardiovascular disease events (HR, 3.0). The risk of CHD events increased with CAC score, with hazard ratios of 2.6, 5.8, and 9.8 for individuals with scores of 1-19, 20-99, and 100 or more, respectively.

In addition, participants with any CAC had an elevated adjusted risk of all-cause mortality (HR, 1.6). This risk similarly rose with score but was significant for those having a score of 100 or greater only (hazard ratio, 3.7); the large majority of deaths in this group were deemed to be from CHD events.

The model that the investigators developed predicted the probability of CAC by ages 32-56 years based on risk factors assessed 7 years apart, between the ages of 18 and 38 years.

When stratified by this model, 4.2% of study participants falling into the lowest-risk decile had CAC, compared with 67.8% of those falling into the highest-risk decile.

Analyses suggested that if screening were restricted to those participants having an above-median risk score, fully 77.3% of all those with coronary calcium and 95.5% of all those with CHD events would be identified. Moreover, these yields would be obtained while reducing the number of individuals recommended to be screened by 50.0%.

Younger adults who have any calcium deposited in their coronary arteries, even a small amount, are at increased risk for adverse coronary heart disease (CHD) outcomes and death, finds an analysis of the Coronary Artery Risk Development in Young Adults (CARDIA) Study.

There’s no evidence, however, that treating such patients would make a difference in outcomes, John Jeffrey Carr, MD, reported in JAMA Cardiology on Feb. 8.

In the prospective, community-based, cohort study, 5,115 black and white adults underwent coronary computed tomographic (CT) imaging between the ages of 32 and 46 years, and had a mean follow-up of 12.5 years.

Compared with counterparts not having any coronary artery calcium (CAC), those having at least some had a 5.0-fold increased risk of CHD events and a 1.6-fold increased risk of death (JAMA Cardiol. 2017 Feb 8; doi: 10.1001/jamacardio.2016.5493).

Estimates suggested that identification of individuals at elevated risk for developing CAC could inform a selective CT screening strategy whereby the number of younger adults screened could be reduced by half, and the number needing to be imaged to find one person with CAC could be reduced from 3.5 to 2.2.

“The finding that CAC present by ages 32-46 years is associated with increased risk of premature CHD and death emphasizes the need for reduction of risk factors and primordial prevention beginning in early life,” wrote Dr. Carr, professor radiology at Vanderbilt University in Nashville, Tenn.

“Whether any kind of general screening for CAC is warranted needs further study, although we suggest that a strategy in which all individuals aged 32 to 46 years are screened is not indicated. Rather, a more targeted approach based on measuring risk factors in early adult life to predict individuals at high risk for developing CAC in whom the CT scan would have the greatest value can be considered,” they propose.
 

Study details

Participants were recruited to CARDIA when aged 18-30 years, and they underwent CAC measurement at 15, 20, and 25 years after recruitment. Incident events were ascertained starting from the time of the year-15 scan.

At that year-15 scan, 10.2% of participants were found to have CAC. The geometric mean Agatston score was 21.6.

In adjusted analyses, participants with any CAC had sharply higher risks of CHD events (hazard ratio, 5.0), as well as cardiovascular disease events (HR, 3.0). The risk of CHD events increased with CAC score, with hazard ratios of 2.6, 5.8, and 9.8 for individuals with scores of 1-19, 20-99, and 100 or more, respectively.

In addition, participants with any CAC had an elevated adjusted risk of all-cause mortality (HR, 1.6). This risk similarly rose with score but was significant for those having a score of 100 or greater only (hazard ratio, 3.7); the large majority of deaths in this group were deemed to be from CHD events.

The model that the investigators developed predicted the probability of CAC by ages 32-56 years based on risk factors assessed 7 years apart, between the ages of 18 and 38 years.

When stratified by this model, 4.2% of study participants falling into the lowest-risk decile had CAC, compared with 67.8% of those falling into the highest-risk decile.

Analyses suggested that if screening were restricted to those participants having an above-median risk score, fully 77.3% of all those with coronary calcium and 95.5% of all those with CHD events would be identified. Moreover, these yields would be obtained while reducing the number of individuals recommended to be screened by 50.0%.

Click here to download the PDF.

Click here to download the PDF.

Click here to download the PDF.

Use of locum tenens physicians reached a new high in 2016, according to an annual survey by Staff Care, a health care staffing company.

Last year, 94% of hospitals, medical groups, and other health care facilities reported using temporary physicians, compared with 91% in 2014, which was the previous high, Staff Care reported in its “2017 Survey of Temporary Physician Staffing Trends.”

[email protected]

Use of locum tenens physicians reached a new high in 2016, according to an annual survey by Staff Care, a health care staffing company.

Last year, 94% of hospitals, medical groups, and other health care facilities reported using temporary physicians, compared with 91% in 2014, which was the previous high, Staff Care reported in its “2017 Survey of Temporary Physician Staffing Trends.”

[email protected]

Use of locum tenens physicians reached a new high in 2016, according to an annual survey by Staff Care, a health care staffing company.

Last year, 94% of hospitals, medical groups, and other health care facilities reported using temporary physicians, compared with 91% in 2014, which was the previous high, Staff Care reported in its “2017 Survey of Temporary Physician Staffing Trends.”

[email protected]

Subcutaneous high-dose methotrexate can be safely initiated in people with moderate to severe psoriasis, and produces a rapid and sustained response, researchers found.

Although methotrexate is a first-line agent in moderate to severe psoriasis, and is considerably cheaper than biological agents, much remains unknown about its ideal dosage and route of administration.

Authors of a 2016 systematic review noted that, despite the fact that methotrexate has been used for more than 50 years in psoriasis, high-quality trial evidence remains wanting (PLoS One 2016 May 11. doi: 10.1371/journal.pone.0153740). Recent, well-designed trials have compared methotrexate to biological drugs used in psoriasis rather than placebo. These studies also have used oral formulations of methotrexate, in a range of starting doses as low as 5 mg, rather than subcutaneous formulations.

Courtesy CDC

Subcutaneous high-dose methotrexate can be safely initiated in people with moderate to severe psoriasis, and produces a rapid and sustained response, researchers found.

Although methotrexate is a first-line agent in moderate to severe psoriasis, and is considerably cheaper than biological agents, much remains unknown about its ideal dosage and route of administration.

Authors of a 2016 systematic review noted that, despite the fact that methotrexate has been used for more than 50 years in psoriasis, high-quality trial evidence remains wanting (PLoS One 2016 May 11. doi: 10.1371/journal.pone.0153740). Recent, well-designed trials have compared methotrexate to biological drugs used in psoriasis rather than placebo. These studies also have used oral formulations of methotrexate, in a range of starting doses as low as 5 mg, rather than subcutaneous formulations.

Courtesy CDC

Subcutaneous high-dose methotrexate can be safely initiated in people with moderate to severe psoriasis, and produces a rapid and sustained response, researchers found.

Although methotrexate is a first-line agent in moderate to severe psoriasis, and is considerably cheaper than biological agents, much remains unknown about its ideal dosage and route of administration.

Authors of a 2016 systematic review noted that, despite the fact that methotrexate has been used for more than 50 years in psoriasis, high-quality trial evidence remains wanting (PLoS One 2016 May 11. doi: 10.1371/journal.pone.0153740). Recent, well-designed trials have compared methotrexate to biological drugs used in psoriasis rather than placebo. These studies also have used oral formulations of methotrexate, in a range of starting doses as low as 5 mg, rather than subcutaneous formulations.

Courtesy CDC