Inpatient palliative care can help maintain quality of life (QoL) in patients undergoing hematopoietic stem cell transplantation (HCT), based on the results of a randomized clinical trial to assess the effect of inpatient palliative care on patient and caregiver-reported outcomes while hospitalized for HCT and for 3 months after transplantation.

During the 2-week period following their transplants, patients who received inpatient palliative care experienced a 14.72-point decrease in QoL, compared with a 21.54-point decrease in QoL for those assigned to standard transplant care alone. The difference was statistically significant (JAMA. 2016;316[20]:2094-2103. doi:10.1001/jama.2016.16786).

In addition to the QoL results, Areej El-Jawahri, MD, of Massachusetts General Hospital in Boston, and coauthors, noted that “exploratory secondary outcomes also showed that patients in the palliative care group benefited, with less increase in their depression symptoms, lower anxiety symptoms, and less increase in symptom burden compared with those receiving standard transplant care.

“Thus, palliative care may help to lessen the decline in QoL experienced by patients during hospitalization for HCT, which has long been perceived as a natural aspect of the transplantation process.”

The study cohort comprised 160 adults with hematologic malignancies undergoing autologous/allogeneic HCT, and 94 caregivers.

A total of 81 patients were assigned to the intervention, and were seen by palliative care clinicians at least twice a week while they were hospitalized. The palliative care intervention focused on managing both physical and psychological symptoms, and those who were assigned to the standard care arm (n = 79) could also request to be seen by the palliative care team.

Quality of life was measured based on mean FACT-BMT score. In the palliative care group, the FACT-BMT score was 110.26 at hospitalization and 95.46 at 2 weeks after transplant (mean change, −14.72). For the standard care group, FACT-BMT score was 106.83 at hospitalization and 85.42 at 2 weeks after transplant (mean change, −21.54) The −6.82 difference between the group groups was statistically significant (95% CI, −13.48 to −0.16; P = .045).

When looking at secondary outcomes, those in the intervention group had lower mean depression scores at 2 weeks based on the HADS-D measure. For the intervention group, the mean baseline score was 3.95 and the mean week 2 score was 6.39. For the control group, the baseline score was 4.94 and the week 2 score was 8.86. The difference between the groups was 1.49 (95% CI, 0.20-2.78; P = .02). Depression scores remained lower in the intervention group at 3 months.

The intervention group also reported a decrease in anxiety symptoms, but the control group reported an increase in anxiety symptoms from baseline to week 2 on the HADS-A measure. The mean difference in score between the two groups was 1.92; (95% CI, 0.83-3.01; P less than .001). However, there was no significant difference between the two groups at 3 months after transplant.

The study was supported by the National Palliative Care Research Foundation and grant K24 CA 181253 from the National Cancer Institute. Dr. El-Jawahri reported no disclosures.

Inpatient palliative care can help maintain quality of life (QoL) in patients undergoing hematopoietic stem cell transplantation (HCT), based on the results of a randomized clinical trial to assess the effect of inpatient palliative care on patient and caregiver-reported outcomes while hospitalized for HCT and for 3 months after transplantation.

During the 2-week period following their transplants, patients who received inpatient palliative care experienced a 14.72-point decrease in QoL, compared with a 21.54-point decrease in QoL for those assigned to standard transplant care alone. The difference was statistically significant (JAMA. 2016;316[20]:2094-2103. doi:10.1001/jama.2016.16786).

In addition to the QoL results, Areej El-Jawahri, MD, of Massachusetts General Hospital in Boston, and coauthors, noted that “exploratory secondary outcomes also showed that patients in the palliative care group benefited, with less increase in their depression symptoms, lower anxiety symptoms, and less increase in symptom burden compared with those receiving standard transplant care.

“Thus, palliative care may help to lessen the decline in QoL experienced by patients during hospitalization for HCT, which has long been perceived as a natural aspect of the transplantation process.”

The study cohort comprised 160 adults with hematologic malignancies undergoing autologous/allogeneic HCT, and 94 caregivers.

A total of 81 patients were assigned to the intervention, and were seen by palliative care clinicians at least twice a week while they were hospitalized. The palliative care intervention focused on managing both physical and psychological symptoms, and those who were assigned to the standard care arm (n = 79) could also request to be seen by the palliative care team.

Quality of life was measured based on mean FACT-BMT score. In the palliative care group, the FACT-BMT score was 110.26 at hospitalization and 95.46 at 2 weeks after transplant (mean change, −14.72). For the standard care group, FACT-BMT score was 106.83 at hospitalization and 85.42 at 2 weeks after transplant (mean change, −21.54) The −6.82 difference between the group groups was statistically significant (95% CI, −13.48 to −0.16; P = .045).

When looking at secondary outcomes, those in the intervention group had lower mean depression scores at 2 weeks based on the HADS-D measure. For the intervention group, the mean baseline score was 3.95 and the mean week 2 score was 6.39. For the control group, the baseline score was 4.94 and the week 2 score was 8.86. The difference between the groups was 1.49 (95% CI, 0.20-2.78; P = .02). Depression scores remained lower in the intervention group at 3 months.

The intervention group also reported a decrease in anxiety symptoms, but the control group reported an increase in anxiety symptoms from baseline to week 2 on the HADS-A measure. The mean difference in score between the two groups was 1.92; (95% CI, 0.83-3.01; P less than .001). However, there was no significant difference between the two groups at 3 months after transplant.

The study was supported by the National Palliative Care Research Foundation and grant K24 CA 181253 from the National Cancer Institute. Dr. El-Jawahri reported no disclosures.

Inpatient palliative care can help maintain quality of life (QoL) in patients undergoing hematopoietic stem cell transplantation (HCT), based on the results of a randomized clinical trial to assess the effect of inpatient palliative care on patient and caregiver-reported outcomes while hospitalized for HCT and for 3 months after transplantation.

During the 2-week period following their transplants, patients who received inpatient palliative care experienced a 14.72-point decrease in QoL, compared with a 21.54-point decrease in QoL for those assigned to standard transplant care alone. The difference was statistically significant (JAMA. 2016;316[20]:2094-2103. doi:10.1001/jama.2016.16786).

In addition to the QoL results, Areej El-Jawahri, MD, of Massachusetts General Hospital in Boston, and coauthors, noted that “exploratory secondary outcomes also showed that patients in the palliative care group benefited, with less increase in their depression symptoms, lower anxiety symptoms, and less increase in symptom burden compared with those receiving standard transplant care.

“Thus, palliative care may help to lessen the decline in QoL experienced by patients during hospitalization for HCT, which has long been perceived as a natural aspect of the transplantation process.”

The study cohort comprised 160 adults with hematologic malignancies undergoing autologous/allogeneic HCT, and 94 caregivers.

A total of 81 patients were assigned to the intervention, and were seen by palliative care clinicians at least twice a week while they were hospitalized. The palliative care intervention focused on managing both physical and psychological symptoms, and those who were assigned to the standard care arm (n = 79) could also request to be seen by the palliative care team.

Quality of life was measured based on mean FACT-BMT score. In the palliative care group, the FACT-BMT score was 110.26 at hospitalization and 95.46 at 2 weeks after transplant (mean change, −14.72). For the standard care group, FACT-BMT score was 106.83 at hospitalization and 85.42 at 2 weeks after transplant (mean change, −21.54) The −6.82 difference between the group groups was statistically significant (95% CI, −13.48 to −0.16; P = .045).

When looking at secondary outcomes, those in the intervention group had lower mean depression scores at 2 weeks based on the HADS-D measure. For the intervention group, the mean baseline score was 3.95 and the mean week 2 score was 6.39. For the control group, the baseline score was 4.94 and the week 2 score was 8.86. The difference between the groups was 1.49 (95% CI, 0.20-2.78; P = .02). Depression scores remained lower in the intervention group at 3 months.

The intervention group also reported a decrease in anxiety symptoms, but the control group reported an increase in anxiety symptoms from baseline to week 2 on the HADS-A measure. The mean difference in score between the two groups was 1.92; (95% CI, 0.83-3.01; P less than .001). However, there was no significant difference between the two groups at 3 months after transplant.

The study was supported by the National Palliative Care Research Foundation and grant K24 CA 181253 from the National Cancer Institute. Dr. El-Jawahri reported no disclosures.

There are many topics within the child psychiatry community that are controversial. How many kids really deserve a diagnosis of bipolar disorder? Which type of therapy works best? Is cannabis a gateway drug? The existence of attention-deficit/hyperactivity disorder as a legitimate psychiatric entity, however, is not one of them.

Despite this fact, there remains considerable controversy in the public about how “real” ADHD actually is. Social media, blogs, and even entire books have been written that disparage the diagnosis and even suggest that ADHD was fabricated by the pharmaceutical industry to sell medications. Although these publications and posts generally ignore the scientific literature or at least twist it beyond recognition, there are several aspects of ADHD that legitimately cause more confusion and less confidence about the diagnosis, relative to other common pediatric problems. This column attempts to describe and contextualize these elements so that pediatricians can be more fully informed when they are called to respond to some of the allegations against ADHD that often are brought up by families.

Case summary

Hunter is a 6-year-old boy who presents with his mother and father for “behavioral concerns.” He always has been an energetic child, but the school has been having increasing difficulties with his behavior. Hunter struggles to stay in his seat and take part in quiet activities. His teacher needs to give multiple reminders per day about not interrupting others or speaking out in class. Without redirection, Hunter typically loses focus in class and does not complete his work. Because of these difficulties, the question of ADHD arose during a recent parent-teacher conference. While Hunter’s mother acknowledges these behaviors and notes similar ones at home, the father is resisting any further evaluation, claiming that Hunter “is just being a boy.” The father notes that he acted similarly as a child and “turned out okay.” When the mother tried to research ADHD online, she encountered several sites that claimed that the diagnosis of ADHD was “made up” by drug companies wanting “to turn kids into zombies.” At the appointment, the parents state that they want their son to succeed and be happy, but are concerned about some of the things they have read on the Internet.

Discussion

This example represents a common dilemma for parents who encounter so many mixed messages when doing background research on ADHD. Although the legitimacy of ADHD has been supported in literally hundreds of research studies that have examined areas such as genetics, neuropsychological testing, and brain imaging^1,2, some of the lingering doubts about ADHD validity are rooted in characteristics of the diagnosis that do differ from some nonpsychiatric diagnoses. At the same time, however, further inspection reveals that these qualities exist for many other entities that have received far less public criticism. Three of these main qualities include the following:

1. ADHD is a dimensional rather than binary entity. Despite the fact that the current nomenclature continues to frame ADHD as an all-or-nothing diagnosis, there is now overwhelming scientific evidence that it is much more accurately conceptualized as a dimension³. As such, there is no clear-cut boundary between what should be judged as “typical” levels of attention and activity and ADHD. As written in a previous column⁴, in some ways the label of ADHD is a lot like the label of someone being tall, with some individuals clearly falling into the category of “tall” or “not tall,” while many others could be considered in-between. However, many of the most common nonpsychiatric conditions such as hypertension and hypercholesterolemia also exist this way without high levels of public controversy.

2. ADHD lacks a specific known neurobiologic marker that can be measured by a lab or neuroimaging test. As mentioned, there is a vast literature supporting the idea that the brains of people with ADHD are different from those without ADHD, but these differences tend to describe quantitative differences in regional brain volume, cortical thickness, activity levels, or connectivity rather than a discrete “thing” that a radiologist can point to on a scan. Given the dimensional nature of ADHD and the broad brain processes required for complex functions such as attention and motor activity, the lack of a specific and universal “lesion” underlying ADHD is to be expected, yet it still remains easy ammunition for those who criticize the diagnosis. Again, very similar cases can be made for other entities such as autism or low intelligence, which few argue are not real but also have no reliable biomarker to support them.

3. Medications often are used to treat ADHD. The diagnosis of ADHD would probably be far less controversial if one of its primary treatments did not involve psychiatric medications. While it is probably fair to say that the many nonpharmacologic approaches to ADHD are quite underutilized, it seems a stretch to use potential overreliance on medication as a legitimate reason to question the validity of a diagnosis. Opiate abuse also is a problem in this country, but that doesn’t mean a person’s pain doesn’t exist. As a practical tip, it can be reassuring for families to hear explicitly from their physician that “zombification” is not considered an acceptable medical outcome and that the prescribing clinician will promptly deal with any side effects that might occur with treatment⁵.

Understanding these aspects about ADHD and how they are misinterpreted in the media can help families make more informed and comfortable decisions about their child’s care in collaboration with their pediatrician. It also is important for pediatricians to be proactive in distributing reliable and science-backed material to the public in this new age of information overload.

Case follow-up

The pediatrician hears the family’s concerns and discusses the evidence supporting the scientific legitimacy of ADHD, as well as some of the qualities of the diagnosis that have led to its controversy. The parents are reassured but would like to proceed carefully and cautiously with further work-up and treatment. The pediatrician sends the family home with some quantitative rating scales to be completed by Hunter’s parents and teacher. She also makes a plan to begin monitoring several health promotion areas that could be impacting Hunter’s behavior including sleep quality, physical activity, screen time, and nutrition.

References

1. Psychiatr Clin North Am. 2010 Mar;33(1):159-80.

2. Dev Neuropsychol. 2013;38(4):211-25.3. Can Fam Physician. 2016 Dec;62(12):979-82.

4. ADHD boundaries with normal behavior. Pediatric News; published online Aug. 27, 2014.

5. Zombification is not an acceptable medical outcome. Psychology Today, ABCs of Child Psychiatry blog; published online Oct. 18, 2013.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych.

There are many topics within the child psychiatry community that are controversial. How many kids really deserve a diagnosis of bipolar disorder? Which type of therapy works best? Is cannabis a gateway drug? The existence of attention-deficit/hyperactivity disorder as a legitimate psychiatric entity, however, is not one of them.

Despite this fact, there remains considerable controversy in the public about how “real” ADHD actually is. Social media, blogs, and even entire books have been written that disparage the diagnosis and even suggest that ADHD was fabricated by the pharmaceutical industry to sell medications. Although these publications and posts generally ignore the scientific literature or at least twist it beyond recognition, there are several aspects of ADHD that legitimately cause more confusion and less confidence about the diagnosis, relative to other common pediatric problems. This column attempts to describe and contextualize these elements so that pediatricians can be more fully informed when they are called to respond to some of the allegations against ADHD that often are brought up by families.

Case summary

Hunter is a 6-year-old boy who presents with his mother and father for “behavioral concerns.” He always has been an energetic child, but the school has been having increasing difficulties with his behavior. Hunter struggles to stay in his seat and take part in quiet activities. His teacher needs to give multiple reminders per day about not interrupting others or speaking out in class. Without redirection, Hunter typically loses focus in class and does not complete his work. Because of these difficulties, the question of ADHD arose during a recent parent-teacher conference. While Hunter’s mother acknowledges these behaviors and notes similar ones at home, the father is resisting any further evaluation, claiming that Hunter “is just being a boy.” The father notes that he acted similarly as a child and “turned out okay.” When the mother tried to research ADHD online, she encountered several sites that claimed that the diagnosis of ADHD was “made up” by drug companies wanting “to turn kids into zombies.” At the appointment, the parents state that they want their son to succeed and be happy, but are concerned about some of the things they have read on the Internet.

Discussion

This example represents a common dilemma for parents who encounter so many mixed messages when doing background research on ADHD. Although the legitimacy of ADHD has been supported in literally hundreds of research studies that have examined areas such as genetics, neuropsychological testing, and brain imaging^1,2, some of the lingering doubts about ADHD validity are rooted in characteristics of the diagnosis that do differ from some nonpsychiatric diagnoses. At the same time, however, further inspection reveals that these qualities exist for many other entities that have received far less public criticism. Three of these main qualities include the following:

1. ADHD is a dimensional rather than binary entity. Despite the fact that the current nomenclature continues to frame ADHD as an all-or-nothing diagnosis, there is now overwhelming scientific evidence that it is much more accurately conceptualized as a dimension³. As such, there is no clear-cut boundary between what should be judged as “typical” levels of attention and activity and ADHD. As written in a previous column⁴, in some ways the label of ADHD is a lot like the label of someone being tall, with some individuals clearly falling into the category of “tall” or “not tall,” while many others could be considered in-between. However, many of the most common nonpsychiatric conditions such as hypertension and hypercholesterolemia also exist this way without high levels of public controversy.

2. ADHD lacks a specific known neurobiologic marker that can be measured by a lab or neuroimaging test. As mentioned, there is a vast literature supporting the idea that the brains of people with ADHD are different from those without ADHD, but these differences tend to describe quantitative differences in regional brain volume, cortical thickness, activity levels, or connectivity rather than a discrete “thing” that a radiologist can point to on a scan. Given the dimensional nature of ADHD and the broad brain processes required for complex functions such as attention and motor activity, the lack of a specific and universal “lesion” underlying ADHD is to be expected, yet it still remains easy ammunition for those who criticize the diagnosis. Again, very similar cases can be made for other entities such as autism or low intelligence, which few argue are not real but also have no reliable biomarker to support them.

3. Medications often are used to treat ADHD. The diagnosis of ADHD would probably be far less controversial if one of its primary treatments did not involve psychiatric medications. While it is probably fair to say that the many nonpharmacologic approaches to ADHD are quite underutilized, it seems a stretch to use potential overreliance on medication as a legitimate reason to question the validity of a diagnosis. Opiate abuse also is a problem in this country, but that doesn’t mean a person’s pain doesn’t exist. As a practical tip, it can be reassuring for families to hear explicitly from their physician that “zombification” is not considered an acceptable medical outcome and that the prescribing clinician will promptly deal with any side effects that might occur with treatment⁵.

Understanding these aspects about ADHD and how they are misinterpreted in the media can help families make more informed and comfortable decisions about their child’s care in collaboration with their pediatrician. It also is important for pediatricians to be proactive in distributing reliable and science-backed material to the public in this new age of information overload.

Case follow-up

The pediatrician hears the family’s concerns and discusses the evidence supporting the scientific legitimacy of ADHD, as well as some of the qualities of the diagnosis that have led to its controversy. The parents are reassured but would like to proceed carefully and cautiously with further work-up and treatment. The pediatrician sends the family home with some quantitative rating scales to be completed by Hunter’s parents and teacher. She also makes a plan to begin monitoring several health promotion areas that could be impacting Hunter’s behavior including sleep quality, physical activity, screen time, and nutrition.

References

1. Psychiatr Clin North Am. 2010 Mar;33(1):159-80.

2. Dev Neuropsychol. 2013;38(4):211-25.3. Can Fam Physician. 2016 Dec;62(12):979-82.

4. ADHD boundaries with normal behavior. Pediatric News; published online Aug. 27, 2014.

5. Zombification is not an acceptable medical outcome. Psychology Today, ABCs of Child Psychiatry blog; published online Oct. 18, 2013.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych.

There are many topics within the child psychiatry community that are controversial. How many kids really deserve a diagnosis of bipolar disorder? Which type of therapy works best? Is cannabis a gateway drug? The existence of attention-deficit/hyperactivity disorder as a legitimate psychiatric entity, however, is not one of them.

Despite this fact, there remains considerable controversy in the public about how “real” ADHD actually is. Social media, blogs, and even entire books have been written that disparage the diagnosis and even suggest that ADHD was fabricated by the pharmaceutical industry to sell medications. Although these publications and posts generally ignore the scientific literature or at least twist it beyond recognition, there are several aspects of ADHD that legitimately cause more confusion and less confidence about the diagnosis, relative to other common pediatric problems. This column attempts to describe and contextualize these elements so that pediatricians can be more fully informed when they are called to respond to some of the allegations against ADHD that often are brought up by families.

Case summary

Hunter is a 6-year-old boy who presents with his mother and father for “behavioral concerns.” He always has been an energetic child, but the school has been having increasing difficulties with his behavior. Hunter struggles to stay in his seat and take part in quiet activities. His teacher needs to give multiple reminders per day about not interrupting others or speaking out in class. Without redirection, Hunter typically loses focus in class and does not complete his work. Because of these difficulties, the question of ADHD arose during a recent parent-teacher conference. While Hunter’s mother acknowledges these behaviors and notes similar ones at home, the father is resisting any further evaluation, claiming that Hunter “is just being a boy.” The father notes that he acted similarly as a child and “turned out okay.” When the mother tried to research ADHD online, she encountered several sites that claimed that the diagnosis of ADHD was “made up” by drug companies wanting “to turn kids into zombies.” At the appointment, the parents state that they want their son to succeed and be happy, but are concerned about some of the things they have read on the Internet.

Discussion

This example represents a common dilemma for parents who encounter so many mixed messages when doing background research on ADHD. Although the legitimacy of ADHD has been supported in literally hundreds of research studies that have examined areas such as genetics, neuropsychological testing, and brain imaging^1,2, some of the lingering doubts about ADHD validity are rooted in characteristics of the diagnosis that do differ from some nonpsychiatric diagnoses. At the same time, however, further inspection reveals that these qualities exist for many other entities that have received far less public criticism. Three of these main qualities include the following:

1. ADHD is a dimensional rather than binary entity. Despite the fact that the current nomenclature continues to frame ADHD as an all-or-nothing diagnosis, there is now overwhelming scientific evidence that it is much more accurately conceptualized as a dimension³. As such, there is no clear-cut boundary between what should be judged as “typical” levels of attention and activity and ADHD. As written in a previous column⁴, in some ways the label of ADHD is a lot like the label of someone being tall, with some individuals clearly falling into the category of “tall” or “not tall,” while many others could be considered in-between. However, many of the most common nonpsychiatric conditions such as hypertension and hypercholesterolemia also exist this way without high levels of public controversy.

2. ADHD lacks a specific known neurobiologic marker that can be measured by a lab or neuroimaging test. As mentioned, there is a vast literature supporting the idea that the brains of people with ADHD are different from those without ADHD, but these differences tend to describe quantitative differences in regional brain volume, cortical thickness, activity levels, or connectivity rather than a discrete “thing” that a radiologist can point to on a scan. Given the dimensional nature of ADHD and the broad brain processes required for complex functions such as attention and motor activity, the lack of a specific and universal “lesion” underlying ADHD is to be expected, yet it still remains easy ammunition for those who criticize the diagnosis. Again, very similar cases can be made for other entities such as autism or low intelligence, which few argue are not real but also have no reliable biomarker to support them.

3. Medications often are used to treat ADHD. The diagnosis of ADHD would probably be far less controversial if one of its primary treatments did not involve psychiatric medications. While it is probably fair to say that the many nonpharmacologic approaches to ADHD are quite underutilized, it seems a stretch to use potential overreliance on medication as a legitimate reason to question the validity of a diagnosis. Opiate abuse also is a problem in this country, but that doesn’t mean a person’s pain doesn’t exist. As a practical tip, it can be reassuring for families to hear explicitly from their physician that “zombification” is not considered an acceptable medical outcome and that the prescribing clinician will promptly deal with any side effects that might occur with treatment⁵.

Understanding these aspects about ADHD and how they are misinterpreted in the media can help families make more informed and comfortable decisions about their child’s care in collaboration with their pediatrician. It also is important for pediatricians to be proactive in distributing reliable and science-backed material to the public in this new age of information overload.

Case follow-up

The pediatrician hears the family’s concerns and discusses the evidence supporting the scientific legitimacy of ADHD, as well as some of the qualities of the diagnosis that have led to its controversy. The parents are reassured but would like to proceed carefully and cautiously with further work-up and treatment. The pediatrician sends the family home with some quantitative rating scales to be completed by Hunter’s parents and teacher. She also makes a plan to begin monitoring several health promotion areas that could be impacting Hunter’s behavior including sleep quality, physical activity, screen time, and nutrition.

References

1. Psychiatr Clin North Am. 2010 Mar;33(1):159-80.

2. Dev Neuropsychol. 2013;38(4):211-25.3. Can Fam Physician. 2016 Dec;62(12):979-82.

4. ADHD boundaries with normal behavior. Pediatric News; published online Aug. 27, 2014.

5. Zombification is not an acceptable medical outcome. Psychology Today, ABCs of Child Psychiatry blog; published online Oct. 18, 2013.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine, Burlington. Follow him on Twitter @PediPsych.

SAN DIEGO – Aggressive, refractory non-Hodgkin lymphomas responded to anti-CD19 chimeric antigen receptor T cells in ZUMA-1, the first multicenter trial of the cellular immunotherapy, based on early data reported at the annual meeting of the American Society of Hematology.

In an interim analysis of 51 patients with diffuse large B-cell lymphomas, 47% had complete remissions and 29% had partial remissions. But the remission rate declined to 33% complete remissions and 6% partial remissions after 3 months.

There have really been no new treatments in the last 20 years for patients with non-Hodgkin lymphoma that does not respond to chemotherapy or recurs after autologous stem cell transplant. With median overall survival of 6 months, and about 8% complete remissions with existing therapies, CAR T cells might be a solution for these patients, said ZUMA-1 investigator Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center in Houston.

In our video interview at the meeting, Dr. Neelapu discussed initial results in the real-world setting of 22 participating centers, most of which had no previous experience with CAR T-cell therapy. With an efficient production and logistics plan, 91% of 110 patients were able to receive the investigational product, known as KTE-C19.

ZUMA-1 is funded by Kite, which makes KTE-C19, and the Leukemia & Lymphoma Society Therapy Acceleration Program. Dr. Neelapu receives research support from and is an advisor to Kite.

[email protected]

On Twitter @maryjodales

SAN DIEGO – Aggressive, refractory non-Hodgkin lymphomas responded to anti-CD19 chimeric antigen receptor T cells in ZUMA-1, the first multicenter trial of the cellular immunotherapy, based on early data reported at the annual meeting of the American Society of Hematology.

In an interim analysis of 51 patients with diffuse large B-cell lymphomas, 47% had complete remissions and 29% had partial remissions. But the remission rate declined to 33% complete remissions and 6% partial remissions after 3 months.

There have really been no new treatments in the last 20 years for patients with non-Hodgkin lymphoma that does not respond to chemotherapy or recurs after autologous stem cell transplant. With median overall survival of 6 months, and about 8% complete remissions with existing therapies, CAR T cells might be a solution for these patients, said ZUMA-1 investigator Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center in Houston.

In our video interview at the meeting, Dr. Neelapu discussed initial results in the real-world setting of 22 participating centers, most of which had no previous experience with CAR T-cell therapy. With an efficient production and logistics plan, 91% of 110 patients were able to receive the investigational product, known as KTE-C19.

ZUMA-1 is funded by Kite, which makes KTE-C19, and the Leukemia & Lymphoma Society Therapy Acceleration Program. Dr. Neelapu receives research support from and is an advisor to Kite.

[email protected]

On Twitter @maryjodales

SAN DIEGO – Aggressive, refractory non-Hodgkin lymphomas responded to anti-CD19 chimeric antigen receptor T cells in ZUMA-1, the first multicenter trial of the cellular immunotherapy, based on early data reported at the annual meeting of the American Society of Hematology.

In an interim analysis of 51 patients with diffuse large B-cell lymphomas, 47% had complete remissions and 29% had partial remissions. But the remission rate declined to 33% complete remissions and 6% partial remissions after 3 months.

There have really been no new treatments in the last 20 years for patients with non-Hodgkin lymphoma that does not respond to chemotherapy or recurs after autologous stem cell transplant. With median overall survival of 6 months, and about 8% complete remissions with existing therapies, CAR T cells might be a solution for these patients, said ZUMA-1 investigator Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center in Houston.

In our video interview at the meeting, Dr. Neelapu discussed initial results in the real-world setting of 22 participating centers, most of which had no previous experience with CAR T-cell therapy. With an efficient production and logistics plan, 91% of 110 patients were able to receive the investigational product, known as KTE-C19.

ZUMA-1 is funded by Kite, which makes KTE-C19, and the Leukemia & Lymphoma Society Therapy Acceleration Program. Dr. Neelapu receives research support from and is an advisor to Kite.

[email protected]

On Twitter @maryjodales

SAN FRANCISCO – Are electronic medical records wreaking havoc for you? Herschel R. Lessin, MD, vice president of the Children’s Medical Group in Poughkeepsie, N.Y., had some EMR recommendations.

In his presentation entitled “Help! My EMR Threw Me Under the Bus!” at the annual meeting of the American Academy of Pediatrics, Dr. Lessin offered the following recommendations for troubleshooting or preventing EMR problems, starting with customizing your EMR right away to reduce alert fatigue.

kokouu/iStockphoto.com

• Document the specifics of a particular condition, treatment, history, or other note when checking boxes.

• Document your thinking in terms of differential diagnoses.

• Document a follow-up plan beyond just checking the box of a patient’s return date.

• Be wary of cutting and pasting too quickly or relying on the template as a standard of care instead of thoughtful application of the evidence.

• Learn the entry fields for diagnosis codes and for medications and their route of administration.

• Double check that you’re clicking the correct patient, medication, and date of service.

• To prevent data breaches, including HIPAA violations, set up different levels of employee access to EMRs and never share your password.

• Narrative notes should be customized and included, even if the records ask many yes/no questions.

• Keep consistent records. Inconsistency in record keeping is one of the fastest ways to end up in litigation, Dr. Lessin warned. Separation of staff duties in filling out different parts of the EMR, failure to review templates, and “hybrid” charts for which the paper and electronic records don’t match are among the biggest risks for inconsistencies.

• Devise a method for tracking and following up with nonresponsive specialists and with patients, checking on their compliance and unique health care needs. “If a patient with diabetes comes in three times between October and February and you don’t give them a flu shot, then when they get the flu, whose fault is that?” he said. “You need some way to track high-risk patients who need immunizations.”

• Enter notes in a timely fashion – knowing that audits will show time and date of entries – and only use addenda to modify notes.

“If you’re going to make any changes in the medical record, you need to do it as an addendum,” Dr. Lessin said. And, of course, never try to erase a record. Even accidental alterations of records that aren’t following the rules can look very bad, he said.

Dr. Lessin is a principal with Physician Integration Consultants in Atlanta.

SAN FRANCISCO – Are electronic medical records wreaking havoc for you? Herschel R. Lessin, MD, vice president of the Children’s Medical Group in Poughkeepsie, N.Y., had some EMR recommendations.

In his presentation entitled “Help! My EMR Threw Me Under the Bus!” at the annual meeting of the American Academy of Pediatrics, Dr. Lessin offered the following recommendations for troubleshooting or preventing EMR problems, starting with customizing your EMR right away to reduce alert fatigue.

kokouu/iStockphoto.com

• Document the specifics of a particular condition, treatment, history, or other note when checking boxes.

• Document your thinking in terms of differential diagnoses.

• Document a follow-up plan beyond just checking the box of a patient’s return date.

• Be wary of cutting and pasting too quickly or relying on the template as a standard of care instead of thoughtful application of the evidence.

• Learn the entry fields for diagnosis codes and for medications and their route of administration.

• Double check that you’re clicking the correct patient, medication, and date of service.

• To prevent data breaches, including HIPAA violations, set up different levels of employee access to EMRs and never share your password.

• Narrative notes should be customized and included, even if the records ask many yes/no questions.

• Keep consistent records. Inconsistency in record keeping is one of the fastest ways to end up in litigation, Dr. Lessin warned. Separation of staff duties in filling out different parts of the EMR, failure to review templates, and “hybrid” charts for which the paper and electronic records don’t match are among the biggest risks for inconsistencies.

• Devise a method for tracking and following up with nonresponsive specialists and with patients, checking on their compliance and unique health care needs. “If a patient with diabetes comes in three times between October and February and you don’t give them a flu shot, then when they get the flu, whose fault is that?” he said. “You need some way to track high-risk patients who need immunizations.”

• Enter notes in a timely fashion – knowing that audits will show time and date of entries – and only use addenda to modify notes.

“If you’re going to make any changes in the medical record, you need to do it as an addendum,” Dr. Lessin said. And, of course, never try to erase a record. Even accidental alterations of records that aren’t following the rules can look very bad, he said.

Dr. Lessin is a principal with Physician Integration Consultants in Atlanta.

SAN FRANCISCO – Are electronic medical records wreaking havoc for you? Herschel R. Lessin, MD, vice president of the Children’s Medical Group in Poughkeepsie, N.Y., had some EMR recommendations.

In his presentation entitled “Help! My EMR Threw Me Under the Bus!” at the annual meeting of the American Academy of Pediatrics, Dr. Lessin offered the following recommendations for troubleshooting or preventing EMR problems, starting with customizing your EMR right away to reduce alert fatigue.

kokouu/iStockphoto.com

• Document the specifics of a particular condition, treatment, history, or other note when checking boxes.

• Document your thinking in terms of differential diagnoses.

• Document a follow-up plan beyond just checking the box of a patient’s return date.

• Be wary of cutting and pasting too quickly or relying on the template as a standard of care instead of thoughtful application of the evidence.

• Learn the entry fields for diagnosis codes and for medications and their route of administration.

• Double check that you’re clicking the correct patient, medication, and date of service.

• To prevent data breaches, including HIPAA violations, set up different levels of employee access to EMRs and never share your password.

• Narrative notes should be customized and included, even if the records ask many yes/no questions.

• Keep consistent records. Inconsistency in record keeping is one of the fastest ways to end up in litigation, Dr. Lessin warned. Separation of staff duties in filling out different parts of the EMR, failure to review templates, and “hybrid” charts for which the paper and electronic records don’t match are among the biggest risks for inconsistencies.

• Devise a method for tracking and following up with nonresponsive specialists and with patients, checking on their compliance and unique health care needs. “If a patient with diabetes comes in three times between October and February and you don’t give them a flu shot, then when they get the flu, whose fault is that?” he said. “You need some way to track high-risk patients who need immunizations.”

• Enter notes in a timely fashion – knowing that audits will show time and date of entries – and only use addenda to modify notes.

“If you’re going to make any changes in the medical record, you need to do it as an addendum,” Dr. Lessin said. And, of course, never try to erase a record. Even accidental alterations of records that aren’t following the rules can look very bad, he said.

Dr. Lessin is a principal with Physician Integration Consultants in Atlanta.

Parents of children with psoriasis experience significant negative quality-of-life issues, according to Dr. Megha Tollefson and her associates.

In interviews with 31 parents of children with psoriasis, four themes impacting quality of life emerged. Parental health and self-care were negatively affected, with 52% reporting affected sleep patterns and 35% reporting difficulty in maintaining self-care. Mental health issues were common as well, with 65% of parents reporting concern over their child’s condition and nearly half of parents reporting excess stress and sadness, anxiety, or depression.

Lori Farmer/Frontline Medical News

[email protected]

Parents of children with psoriasis experience significant negative quality-of-life issues, according to Dr. Megha Tollefson and her associates.

In interviews with 31 parents of children with psoriasis, four themes impacting quality of life emerged. Parental health and self-care were negatively affected, with 52% reporting affected sleep patterns and 35% reporting difficulty in maintaining self-care. Mental health issues were common as well, with 65% of parents reporting concern over their child’s condition and nearly half of parents reporting excess stress and sadness, anxiety, or depression.

Lori Farmer/Frontline Medical News

[email protected]

Parents of children with psoriasis experience significant negative quality-of-life issues, according to Dr. Megha Tollefson and her associates.

In interviews with 31 parents of children with psoriasis, four themes impacting quality of life emerged. Parental health and self-care were negatively affected, with 52% reporting affected sleep patterns and 35% reporting difficulty in maintaining self-care. Mental health issues were common as well, with 65% of parents reporting concern over their child’s condition and nearly half of parents reporting excess stress and sadness, anxiety, or depression.

Lori Farmer/Frontline Medical News

[email protected]

Hospitals that frequently treat acute COPD exacerbations using noninvasive ventilation – a practice known to reduce mortality, length of stay, and the need for more invasive treatment – did not have better patient outcomes than did hospitals that used noninvasive ventilation less frequently, according to a report published in Annals of the American Thoracic Society.

Acute COPD exacerbations are “one of the few conditions with high-level evidence demonstrating the benefits of noninvasive ventilation in patients with respiratory distress,” and the treatment has been widely adopted for this patient population. However, for noninvasive ventilation to succeed, patients must be carefully selected and closely monitored, and a multidisciplinary team of nurses, respiratory therapists, and physicians must coordinate the treatment, often across multiple hospital settings, said Anuj B. Mehta, MD, of The Pulmonary Center, Boston University, and his associates.

Until now, it was not known whether hospitals with a high volume of noninvasive ventilation develop specialized expertise and thus deliver superior patient outcomes, or whether a high volume results from suboptimal patient selection or otherwise puts a strain on a hospital’s staff and thus produces poor outcomes. To examine this question, Dr. Mehta and his associates analyzed information in a database enrolling adults treated at 252 California hospitals for acute COPD exacerbation. They focused on 37,516 hospitalizations that occurred during a single year.

Overall, 9.3% of these patients received noninvasive ventilation. The median annual case volume of noninvasive ventilation for any indication was 64 per hospital. But rates of noninvasive ventilation varied widely across hospitals, with 40% of facilities significantly deviating from this median rate.

“Contrary to our hypothesis, we did not observe significantly lower COPD mortality” in hospitals with high volumes of noninvasive ventilation. For individual patients, admission to a hospital with a high volume of noninvasive ventilation was associated with significantly higher odds of treatment failure (adjusted OR, 1.95), and such failure was associated with significantly higher odds of death (adjusted OR, 1.81). In addition, at the hospital level, a high volume of noninvasive ventilation was associated with a significantly higher risk of treatment failure, which in turn was associated with higher patient mortality.

“Hospitals with higher total noninvasive ventilation case volume tended to use [it] in patients with more comorbidities and acute organ failures, suggesting potential overuse among patients at higher risk of treatment failure. ... [This] may partially explain why hospitals with high rates of using an evidence-based intervention did not achieve significant mortality benefits,” Dr. Mehta and his associates said (Ann Am Thorac Soc. 2016;13[10]:1752-9).

They added that the wide variation between hospitals in failure rates for noninvasive ventilation were likely attributable to unmeasured hospital factors, speculating that the site of treatment (regular ward vs. ICU); staffing ratios for nurses, respiratory therapists, and physicians; and the intensity of patient monitoring, such as the frequency of blood-gas measurement, may contribute.

“High rates of treatment failure at some hospitals suggest that further work is needed to maximize the real-world effectiveness of noninvasive ventilation, even for an indication [backed by] strong evidence,” the investigators said.

The National Institutes of Health; the National Heart, Lung, and Blood Institute; and Boston University supported the study. The investigators’ financial disclosures are available at www.atsjournals.org.

Hospitals that frequently treat acute COPD exacerbations using noninvasive ventilation – a practice known to reduce mortality, length of stay, and the need for more invasive treatment – did not have better patient outcomes than did hospitals that used noninvasive ventilation less frequently, according to a report published in Annals of the American Thoracic Society.

Acute COPD exacerbations are “one of the few conditions with high-level evidence demonstrating the benefits of noninvasive ventilation in patients with respiratory distress,” and the treatment has been widely adopted for this patient population. However, for noninvasive ventilation to succeed, patients must be carefully selected and closely monitored, and a multidisciplinary team of nurses, respiratory therapists, and physicians must coordinate the treatment, often across multiple hospital settings, said Anuj B. Mehta, MD, of The Pulmonary Center, Boston University, and his associates.

Until now, it was not known whether hospitals with a high volume of noninvasive ventilation develop specialized expertise and thus deliver superior patient outcomes, or whether a high volume results from suboptimal patient selection or otherwise puts a strain on a hospital’s staff and thus produces poor outcomes. To examine this question, Dr. Mehta and his associates analyzed information in a database enrolling adults treated at 252 California hospitals for acute COPD exacerbation. They focused on 37,516 hospitalizations that occurred during a single year.

Overall, 9.3% of these patients received noninvasive ventilation. The median annual case volume of noninvasive ventilation for any indication was 64 per hospital. But rates of noninvasive ventilation varied widely across hospitals, with 40% of facilities significantly deviating from this median rate.

“Contrary to our hypothesis, we did not observe significantly lower COPD mortality” in hospitals with high volumes of noninvasive ventilation. For individual patients, admission to a hospital with a high volume of noninvasive ventilation was associated with significantly higher odds of treatment failure (adjusted OR, 1.95), and such failure was associated with significantly higher odds of death (adjusted OR, 1.81). In addition, at the hospital level, a high volume of noninvasive ventilation was associated with a significantly higher risk of treatment failure, which in turn was associated with higher patient mortality.

“Hospitals with higher total noninvasive ventilation case volume tended to use [it] in patients with more comorbidities and acute organ failures, suggesting potential overuse among patients at higher risk of treatment failure. ... [This] may partially explain why hospitals with high rates of using an evidence-based intervention did not achieve significant mortality benefits,” Dr. Mehta and his associates said (Ann Am Thorac Soc. 2016;13[10]:1752-9).

They added that the wide variation between hospitals in failure rates for noninvasive ventilation were likely attributable to unmeasured hospital factors, speculating that the site of treatment (regular ward vs. ICU); staffing ratios for nurses, respiratory therapists, and physicians; and the intensity of patient monitoring, such as the frequency of blood-gas measurement, may contribute.

“High rates of treatment failure at some hospitals suggest that further work is needed to maximize the real-world effectiveness of noninvasive ventilation, even for an indication [backed by] strong evidence,” the investigators said.

The National Institutes of Health; the National Heart, Lung, and Blood Institute; and Boston University supported the study. The investigators’ financial disclosures are available at www.atsjournals.org.

Hospitals that frequently treat acute COPD exacerbations using noninvasive ventilation – a practice known to reduce mortality, length of stay, and the need for more invasive treatment – did not have better patient outcomes than did hospitals that used noninvasive ventilation less frequently, according to a report published in Annals of the American Thoracic Society.

Acute COPD exacerbations are “one of the few conditions with high-level evidence demonstrating the benefits of noninvasive ventilation in patients with respiratory distress,” and the treatment has been widely adopted for this patient population. However, for noninvasive ventilation to succeed, patients must be carefully selected and closely monitored, and a multidisciplinary team of nurses, respiratory therapists, and physicians must coordinate the treatment, often across multiple hospital settings, said Anuj B. Mehta, MD, of The Pulmonary Center, Boston University, and his associates.

Until now, it was not known whether hospitals with a high volume of noninvasive ventilation develop specialized expertise and thus deliver superior patient outcomes, or whether a high volume results from suboptimal patient selection or otherwise puts a strain on a hospital’s staff and thus produces poor outcomes. To examine this question, Dr. Mehta and his associates analyzed information in a database enrolling adults treated at 252 California hospitals for acute COPD exacerbation. They focused on 37,516 hospitalizations that occurred during a single year.

Overall, 9.3% of these patients received noninvasive ventilation. The median annual case volume of noninvasive ventilation for any indication was 64 per hospital. But rates of noninvasive ventilation varied widely across hospitals, with 40% of facilities significantly deviating from this median rate.

“Contrary to our hypothesis, we did not observe significantly lower COPD mortality” in hospitals with high volumes of noninvasive ventilation. For individual patients, admission to a hospital with a high volume of noninvasive ventilation was associated with significantly higher odds of treatment failure (adjusted OR, 1.95), and such failure was associated with significantly higher odds of death (adjusted OR, 1.81). In addition, at the hospital level, a high volume of noninvasive ventilation was associated with a significantly higher risk of treatment failure, which in turn was associated with higher patient mortality.

“Hospitals with higher total noninvasive ventilation case volume tended to use [it] in patients with more comorbidities and acute organ failures, suggesting potential overuse among patients at higher risk of treatment failure. ... [This] may partially explain why hospitals with high rates of using an evidence-based intervention did not achieve significant mortality benefits,” Dr. Mehta and his associates said (Ann Am Thorac Soc. 2016;13[10]:1752-9).

They added that the wide variation between hospitals in failure rates for noninvasive ventilation were likely attributable to unmeasured hospital factors, speculating that the site of treatment (regular ward vs. ICU); staffing ratios for nurses, respiratory therapists, and physicians; and the intensity of patient monitoring, such as the frequency of blood-gas measurement, may contribute.

“High rates of treatment failure at some hospitals suggest that further work is needed to maximize the real-world effectiveness of noninvasive ventilation, even for an indication [backed by] strong evidence,” the investigators said.

The National Institutes of Health; the National Heart, Lung, and Blood Institute; and Boston University supported the study. The investigators’ financial disclosures are available at www.atsjournals.org.

The Food and Drug Administration and the Environmental Protection Agency have issued updated guidance about fish consumption for pregnant women and young children, clarifying which types of fish are recommended and what types of fish to avoid.

In guidance issued Jan. 18, the agencies sort 62 types of fish into three categories based on mercury level: best choices, good choices, and fish to avoid. They recommend that women who are pregnant, women who may become pregnant, breastfeeding mothers, and young children eat two to three servings of fish in the “best choices” category per week. Women and young children are advised to eat one serving per week of fish in the “good choices” category, according to the announcement. Fish in the “best choices” category make up nearly 90% of fish eaten in the United States, according to the FDA.

[email protected]

On Twitter @legal_med

The Food and Drug Administration and the Environmental Protection Agency have issued updated guidance about fish consumption for pregnant women and young children, clarifying which types of fish are recommended and what types of fish to avoid.

In guidance issued Jan. 18, the agencies sort 62 types of fish into three categories based on mercury level: best choices, good choices, and fish to avoid. They recommend that women who are pregnant, women who may become pregnant, breastfeeding mothers, and young children eat two to three servings of fish in the “best choices” category per week. Women and young children are advised to eat one serving per week of fish in the “good choices” category, according to the announcement. Fish in the “best choices” category make up nearly 90% of fish eaten in the United States, according to the FDA.

[email protected]

On Twitter @legal_med

The Food and Drug Administration and the Environmental Protection Agency have issued updated guidance about fish consumption for pregnant women and young children, clarifying which types of fish are recommended and what types of fish to avoid.

In guidance issued Jan. 18, the agencies sort 62 types of fish into three categories based on mercury level: best choices, good choices, and fish to avoid. They recommend that women who are pregnant, women who may become pregnant, breastfeeding mothers, and young children eat two to three servings of fish in the “best choices” category per week. Women and young children are advised to eat one serving per week of fish in the “good choices” category, according to the announcement. Fish in the “best choices” category make up nearly 90% of fish eaten in the United States, according to the FDA.

[email protected]

On Twitter @legal_med

As Republicans dig in to make good on their promise to repeal the Affordable Care Act, hints at what an eventual replacement may look like can be gleaned from legislation previously introduced in the House of Representatives.

One model could be the Empowering Patients First Act (H.R. 2300), sponsored by Rep. Tom Price (R-Ga.), a retired orthopedic surgeon and President-elect Trump’s nominee to head the Health and Human Services department. That legislation offers up a number of the usual GOP proposals related to health care, including refundable tax credits for low-income individuals buying insurance on the individual market; federal grants for states to provide health coverage through a high-risk pool, a reinsurance pool, or other mechanism to help subsidize the purchase of insurance; allowing individuals to purchase insurance through individual member associations; allowing small business owners to purchase insurance for their families and employees across state lines through their trade associations; and allowing insurance companies to sell coverage across state lines.

[email protected]

As Republicans dig in to make good on their promise to repeal the Affordable Care Act, hints at what an eventual replacement may look like can be gleaned from legislation previously introduced in the House of Representatives.

One model could be the Empowering Patients First Act (H.R. 2300), sponsored by Rep. Tom Price (R-Ga.), a retired orthopedic surgeon and President-elect Trump’s nominee to head the Health and Human Services department. That legislation offers up a number of the usual GOP proposals related to health care, including refundable tax credits for low-income individuals buying insurance on the individual market; federal grants for states to provide health coverage through a high-risk pool, a reinsurance pool, or other mechanism to help subsidize the purchase of insurance; allowing individuals to purchase insurance through individual member associations; allowing small business owners to purchase insurance for their families and employees across state lines through their trade associations; and allowing insurance companies to sell coverage across state lines.

[email protected]

As Republicans dig in to make good on their promise to repeal the Affordable Care Act, hints at what an eventual replacement may look like can be gleaned from legislation previously introduced in the House of Representatives.

One model could be the Empowering Patients First Act (H.R. 2300), sponsored by Rep. Tom Price (R-Ga.), a retired orthopedic surgeon and President-elect Trump’s nominee to head the Health and Human Services department. That legislation offers up a number of the usual GOP proposals related to health care, including refundable tax credits for low-income individuals buying insurance on the individual market; federal grants for states to provide health coverage through a high-risk pool, a reinsurance pool, or other mechanism to help subsidize the purchase of insurance; allowing individuals to purchase insurance through individual member associations; allowing small business owners to purchase insurance for their families and employees across state lines through their trade associations; and allowing insurance companies to sell coverage across state lines.

[email protected]

Firefighters in front of a
burning building in Quebec
Photo by Sylvain Pedneault

New research suggests that prolonged exposure to work-related stress may increase a man’s risk of several cancers.

The study showed a significant association between work-related stress lasting 15 years or more and non-Hodgkin lymphoma (NHL) as well as lung, colon, rectal, and stomach cancers.

Men who had worked as firefighters, engineers, mechanics, and repair workers were most likely to report work-related stress.

Marie-Élise Parent, PhD, of Institut national de la recherche scientifique (INRS) in Laval, Quebec, Canada, and her colleagues conducted this research and published

the results in Preventive Medicine.

The researchers studied 3103 men with 11 different types of cancer who were diagnosed from 1979 to 1985. The team compared these men to 512 control subjects from the general population.

Both cases and controls were interviewed and asked to describe each job they had during their lifetime, including the occurrence of stress related to a job and the reason for that stress.

The researchers then calculated odds ratios (OR) for the association between perceived workplace stress and its duration, and each cancer site. The analyses were adjusted for lifestyle and occupational factors.

The team found that having at least one stressful job in a lifetime was associated with increased odds of 5 cancers:

• Lung—OR=1.33
• Colon—OR=1.51
• Bladder—OR=1.37
• Rectal—OR=1.52
• Stomach—OR=1.53.

When the researchers looked at the duration of stress, they found no significant association between any of the cancers and work-related stress lasting less than 15 years.

However, there were significant associations for several cancers and work-related stress lasting 15 to 30 years or more than 30 years. These included:

• NHL—15-30 years, OR=1.47; >30 years, OR=1.69 (P=0.02)
• Lung cancer—15-30 years, OR=1.47; >30 years, OR=1.51 (P=0.01)
• Colon cancer—15-30 years, OR=1.32; >30 years, OR=1.64 (P<0.01)
• Rectal cancer—15-30 years, OR=1.84; >30 years, OR=1.48 (P=0.01)
• Stomach cancer—15-30 years, OR=2.15; >30 years, OR=1.48 (P=0.01).

The occupations with the highest prevalence of work-related stress were firefighter (40% of firefighting jobs reported as stressful), industrial and aerospace engineer (31%), and motor vehicle and rail transport mechanic/repair worker (28%).

For the same individual, stress varied depending on the job held.

The study also showed that perceived stress was not limited to high work load and time constraints. Customer service, sales commissions, responsibilities, having an anxious temperament, job insecurity, financial problems, challenging or dangerous work conditions, employee supervision, interpersonal conflict, and a difficult commute were all sources of stress listed by study participants.
 
The researchers said one of the biggest flaws in previous studies of this kind is that none of them assessed work-related stress over a full working lifetime. The team said this made it impossible to determine how the duration of exposure to work-related stress affects cancer development.

This study, on the other hand, shows the importance of measuring stress at different points in an individual’s working life, the researchers said. They added that their results raise the question of whether chronic psychological stress should be viewed as a public health issue.

However, the team also pointed out that these results are unsubstantiated because they are based on a summary assessment of work-related stress for a given job. There is a need for epidemiological studies based on reliable stress measurements, repeated over time, and that take all sources of stress into account.

Firefighters in front of a
burning building in Quebec
Photo by Sylvain Pedneault

New research suggests that prolonged exposure to work-related stress may increase a man’s risk of several cancers.

The study showed a significant association between work-related stress lasting 15 years or more and non-Hodgkin lymphoma (NHL) as well as lung, colon, rectal, and stomach cancers.

Men who had worked as firefighters, engineers, mechanics, and repair workers were most likely to report work-related stress.

Marie-Élise Parent, PhD, of Institut national de la recherche scientifique (INRS) in Laval, Quebec, Canada, and her colleagues conducted this research and published

the results in Preventive Medicine.

The researchers studied 3103 men with 11 different types of cancer who were diagnosed from 1979 to 1985. The team compared these men to 512 control subjects from the general population.

Both cases and controls were interviewed and asked to describe each job they had during their lifetime, including the occurrence of stress related to a job and the reason for that stress.

The researchers then calculated odds ratios (OR) for the association between perceived workplace stress and its duration, and each cancer site. The analyses were adjusted for lifestyle and occupational factors.

The team found that having at least one stressful job in a lifetime was associated with increased odds of 5 cancers:

• Lung—OR=1.33
• Colon—OR=1.51
• Bladder—OR=1.37
• Rectal—OR=1.52
• Stomach—OR=1.53.

When the researchers looked at the duration of stress, they found no significant association between any of the cancers and work-related stress lasting less than 15 years.

However, there were significant associations for several cancers and work-related stress lasting 15 to 30 years or more than 30 years. These included:

• NHL—15-30 years, OR=1.47; >30 years, OR=1.69 (P=0.02)
• Lung cancer—15-30 years, OR=1.47; >30 years, OR=1.51 (P=0.01)
• Colon cancer—15-30 years, OR=1.32; >30 years, OR=1.64 (P<0.01)
• Rectal cancer—15-30 years, OR=1.84; >30 years, OR=1.48 (P=0.01)
• Stomach cancer—15-30 years, OR=2.15; >30 years, OR=1.48 (P=0.01).

The occupations with the highest prevalence of work-related stress were firefighter (40% of firefighting jobs reported as stressful), industrial and aerospace engineer (31%), and motor vehicle and rail transport mechanic/repair worker (28%).

For the same individual, stress varied depending on the job held.

The study also showed that perceived stress was not limited to high work load and time constraints. Customer service, sales commissions, responsibilities, having an anxious temperament, job insecurity, financial problems, challenging or dangerous work conditions, employee supervision, interpersonal conflict, and a difficult commute were all sources of stress listed by study participants.
 
The researchers said one of the biggest flaws in previous studies of this kind is that none of them assessed work-related stress over a full working lifetime. The team said this made it impossible to determine how the duration of exposure to work-related stress affects cancer development.

This study, on the other hand, shows the importance of measuring stress at different points in an individual’s working life, the researchers said. They added that their results raise the question of whether chronic psychological stress should be viewed as a public health issue.

However, the team also pointed out that these results are unsubstantiated because they are based on a summary assessment of work-related stress for a given job. There is a need for epidemiological studies based on reliable stress measurements, repeated over time, and that take all sources of stress into account.

Firefighters in front of a
burning building in Quebec
Photo by Sylvain Pedneault

New research suggests that prolonged exposure to work-related stress may increase a man’s risk of several cancers.

The study showed a significant association between work-related stress lasting 15 years or more and non-Hodgkin lymphoma (NHL) as well as lung, colon, rectal, and stomach cancers.

Men who had worked as firefighters, engineers, mechanics, and repair workers were most likely to report work-related stress.

Marie-Élise Parent, PhD, of Institut national de la recherche scientifique (INRS) in Laval, Quebec, Canada, and her colleagues conducted this research and published

the results in Preventive Medicine.

The researchers studied 3103 men with 11 different types of cancer who were diagnosed from 1979 to 1985. The team compared these men to 512 control subjects from the general population.

Both cases and controls were interviewed and asked to describe each job they had during their lifetime, including the occurrence of stress related to a job and the reason for that stress.

The researchers then calculated odds ratios (OR) for the association between perceived workplace stress and its duration, and each cancer site. The analyses were adjusted for lifestyle and occupational factors.

The team found that having at least one stressful job in a lifetime was associated with increased odds of 5 cancers:

• Lung—OR=1.33
• Colon—OR=1.51
• Bladder—OR=1.37
• Rectal—OR=1.52
• Stomach—OR=1.53.

When the researchers looked at the duration of stress, they found no significant association between any of the cancers and work-related stress lasting less than 15 years.

However, there were significant associations for several cancers and work-related stress lasting 15 to 30 years or more than 30 years. These included:

• NHL—15-30 years, OR=1.47; >30 years, OR=1.69 (P=0.02)
• Lung cancer—15-30 years, OR=1.47; >30 years, OR=1.51 (P=0.01)
• Colon cancer—15-30 years, OR=1.32; >30 years, OR=1.64 (P<0.01)
• Rectal cancer—15-30 years, OR=1.84; >30 years, OR=1.48 (P=0.01)
• Stomach cancer—15-30 years, OR=2.15; >30 years, OR=1.48 (P=0.01).

The occupations with the highest prevalence of work-related stress were firefighter (40% of firefighting jobs reported as stressful), industrial and aerospace engineer (31%), and motor vehicle and rail transport mechanic/repair worker (28%).

For the same individual, stress varied depending on the job held.

The study also showed that perceived stress was not limited to high work load and time constraints. Customer service, sales commissions, responsibilities, having an anxious temperament, job insecurity, financial problems, challenging or dangerous work conditions, employee supervision, interpersonal conflict, and a difficult commute were all sources of stress listed by study participants.
 
The researchers said one of the biggest flaws in previous studies of this kind is that none of them assessed work-related stress over a full working lifetime. The team said this made it impossible to determine how the duration of exposure to work-related stress affects cancer development.

This study, on the other hand, shows the importance of measuring stress at different points in an individual’s working life, the researchers said. They added that their results raise the question of whether chronic psychological stress should be viewed as a public health issue.

However, the team also pointed out that these results are unsubstantiated because they are based on a summary assessment of work-related stress for a given job. There is a need for epidemiological studies based on reliable stress measurements, repeated over time, and that take all sources of stress into account.

Drug production
Photo courtesy of the FDA

An investigation by Kaiser Health News (KHN) suggests some pharmaceutical companies are using the Orphan Drug Act to create monopolies and charge high prices for drugs that are already approved for mass market use in the US.

The US Food and Drug Administration (FDA) grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent conditions that affect fewer than 200,000 people in the US.

The designation provides incentives for sponsors to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

However, the KHN investigation showed that some companies have been applying for—and obtaining—orphan designation for drugs already used to treat large populations.

The report states that more than 70 drugs that currently have orphan status were first approved by the FDA for mass market use.

In fact, 7 of the 10 best-selling drugs of 2015 were also orphan drugs. Included on this list are Rituxan (rituximab), Neulasta (pegfilgrastim), and Revlimid (lenalidomide).

The report also states that more than 80 drugs with orphan designation have been approved to treat more than one rare disease. For example, Gleevec (imatinib) has 9 orphan designations.

The KHN investigation revealed that, overall, about a third of orphan designations granted since the Orphan Drug Act was passed in 1983 have been either for repurposed mass market drugs or drugs that received multiple orphan designations. (Roughly 450 orphan drugs have been brought to market since 1983, according to the report.)

For each orphan designation, a drug’s developer qualifies for “a fresh batch of incentives,” the report notes.

The exclusivity incentive means the FDA won’t approve another version of an orphan drug to treat the rare disease(s) in question for 7 years, even if the company’s patent on the brand-name drug has expired.

For example, generic versions of imatinib are being used to treat chronic myeloid leukemia in the US because the patent for Gleevec has expired. However, because of an orphan designation, Novartis still has exclusivity for Gleevec (and will until 2020) as a treatment for patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia who are also on chemotherapy.

The KHN report notes that exclusivity can be “a potent pricing tool” due to a lack of competition. And this means orphan drugs may “come with astronomical price tags.”

For instance, there are 33 orphan drugs that cost at least $28,000 for a 30-day supply and 4 orphan drugs that cost more than $70,000 per month.

According to the KHN report, the FDA is planning to investigate this issue.

Gayatri Rao, MD, director of the FDA’s Office of Orphan Products Development, has asked for a review of all orphan designations granted in 2010 and 2015. She said the review will not extend further because the FDA does not have the resources to review all orphan drugs.

Drug production
Photo courtesy of the FDA

An investigation by Kaiser Health News (KHN) suggests some pharmaceutical companies are using the Orphan Drug Act to create monopolies and charge high prices for drugs that are already approved for mass market use in the US.

The US Food and Drug Administration (FDA) grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent conditions that affect fewer than 200,000 people in the US.

The designation provides incentives for sponsors to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

However, the KHN investigation showed that some companies have been applying for—and obtaining—orphan designation for drugs already used to treat large populations.

The report states that more than 70 drugs that currently have orphan status were first approved by the FDA for mass market use.

In fact, 7 of the 10 best-selling drugs of 2015 were also orphan drugs. Included on this list are Rituxan (rituximab), Neulasta (pegfilgrastim), and Revlimid (lenalidomide).

The report also states that more than 80 drugs with orphan designation have been approved to treat more than one rare disease. For example, Gleevec (imatinib) has 9 orphan designations.

The KHN investigation revealed that, overall, about a third of orphan designations granted since the Orphan Drug Act was passed in 1983 have been either for repurposed mass market drugs or drugs that received multiple orphan designations. (Roughly 450 orphan drugs have been brought to market since 1983, according to the report.)

For each orphan designation, a drug’s developer qualifies for “a fresh batch of incentives,” the report notes.

The exclusivity incentive means the FDA won’t approve another version of an orphan drug to treat the rare disease(s) in question for 7 years, even if the company’s patent on the brand-name drug has expired.

For example, generic versions of imatinib are being used to treat chronic myeloid leukemia in the US because the patent for Gleevec has expired. However, because of an orphan designation, Novartis still has exclusivity for Gleevec (and will until 2020) as a treatment for patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia who are also on chemotherapy.

The KHN report notes that exclusivity can be “a potent pricing tool” due to a lack of competition. And this means orphan drugs may “come with astronomical price tags.”

For instance, there are 33 orphan drugs that cost at least $28,000 for a 30-day supply and 4 orphan drugs that cost more than $70,000 per month.

According to the KHN report, the FDA is planning to investigate this issue.

Gayatri Rao, MD, director of the FDA’s Office of Orphan Products Development, has asked for a review of all orphan designations granted in 2010 and 2015. She said the review will not extend further because the FDA does not have the resources to review all orphan drugs.

Drug production
Photo courtesy of the FDA

An investigation by Kaiser Health News (KHN) suggests some pharmaceutical companies are using the Orphan Drug Act to create monopolies and charge high prices for drugs that are already approved for mass market use in the US.

The US Food and Drug Administration (FDA) grants orphan designation to drugs and biologics intended to treat, diagnose, or prevent conditions that affect fewer than 200,000 people in the US.

The designation provides incentives for sponsors to develop products for rare diseases. This includes a 50% tax break on research and development, a fee waiver, access to federal grants, and 7 years of market exclusivity if the product is approved.

However, the KHN investigation showed that some companies have been applying for—and obtaining—orphan designation for drugs already used to treat large populations.

The report states that more than 70 drugs that currently have orphan status were first approved by the FDA for mass market use.

In fact, 7 of the 10 best-selling drugs of 2015 were also orphan drugs. Included on this list are Rituxan (rituximab), Neulasta (pegfilgrastim), and Revlimid (lenalidomide).

The report also states that more than 80 drugs with orphan designation have been approved to treat more than one rare disease. For example, Gleevec (imatinib) has 9 orphan designations.

The KHN investigation revealed that, overall, about a third of orphan designations granted since the Orphan Drug Act was passed in 1983 have been either for repurposed mass market drugs or drugs that received multiple orphan designations. (Roughly 450 orphan drugs have been brought to market since 1983, according to the report.)

For each orphan designation, a drug’s developer qualifies for “a fresh batch of incentives,” the report notes.

The exclusivity incentive means the FDA won’t approve another version of an orphan drug to treat the rare disease(s) in question for 7 years, even if the company’s patent on the brand-name drug has expired.

For example, generic versions of imatinib are being used to treat chronic myeloid leukemia in the US because the patent for Gleevec has expired. However, because of an orphan designation, Novartis still has exclusivity for Gleevec (and will until 2020) as a treatment for patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia who are also on chemotherapy.

The KHN report notes that exclusivity can be “a potent pricing tool” due to a lack of competition. And this means orphan drugs may “come with astronomical price tags.”

For instance, there are 33 orphan drugs that cost at least $28,000 for a 30-day supply and 4 orphan drugs that cost more than $70,000 per month.

According to the KHN report, the FDA is planning to investigate this issue.

Gayatri Rao, MD, director of the FDA’s Office of Orphan Products Development, has asked for a review of all orphan designations granted in 2010 and 2015. She said the review will not extend further because the FDA does not have the resources to review all orphan drugs.