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Transplant safety has improved for patients with diabetes
SAN DIEGO – The risks for patients with diabetes who face organ transplants have diminished greatly, according to an endocrinologist.
But there are still many limitations for these patients – some transplants are not appropriate for patients with diabetes – and there are potential complications when they do get transplants.
“While it used to be that outcomes were worse in patients with diabetes, such as more infections and higher mortality, this has become much less so over time, because of team-based care and better focus on diabetes management postoperatively,” said Jennifer Larsen, MD. Still, “the complexities come with the variable other factors and conditions the patient might have, such as autonomic neuropathies, the sudden variations in kidney function that can occur before and after transplant, and the impact of the transplant medications on other aspects of diabetes care such as lipid management and metabolism of other drugs.”
“They also take care of diabetes patients who get other types of transplant such as heart transplant, liver, and lung,” said Dr. Larsen, vice chancellor for research and professor of internal medicine at University of Nebraska Medical Center, Omaha.
And, she added, they take care of patients who develop diabetes after transplants – posttransplant diabetes. “So it’s important to the endocrinologist today to be familiar with the transplant world, the medicines used, and how chronic kidney disease impacts diabetes management,” she said.
Endocrinologists serve in a variety of roles when patients need transplants, she added. “In some cases the transplant surgeon is referring to us, the endocrinologist. If the patient is heading toward kidney transplant in particular, the pancreas and islet options with kidney transplants would all be handled by the transplant nephrologists, who work hand in hand with the transplant surgeons. Some endocrinologists are embedded in these teams, too.”
Patients with diabetes complicated by chronic kidney disease may be eligible for a transplant of a kidney – in line with the adage that “any kidney is better than dialysis,” Dr. Larsen said – or kidney/pancreas or kidney/islet transplants.
Kidney/pancreas and kidney/islet transplants may be performed simultaneously or with the kidney transplant first. However, islet transplants are not appropriate for patients with type 2 diabetes, and these patients also may not be eligible for simultaneous kidney/pancreas transplants.
According to the United Network for Organ Sharing, there were more than 415,075 kidney transplants from Jan. 1, 1988, to June 30, 2017 (www.unos.org/data). The numbers for pancreas and kidney/pancreas transplants are 8,462 and 22,496, respectively. Islet transplant numbers were not available.
Five-year patient survival rates for kidney transplants are 85%, and graft survival rates are 71%, Dr. Larsen said, and they’re similar for kidney/pancreas transplants. According to Dr. Larsen, patient survival is lower after islet transplantation.
Adjusted patient and graft survival rates in kidney transplants are the same among nondiabetic patients and those with diabetes (Nephrol Dial Transplant. 2002.17[9]:1678-83).
Diabetes complications can affect patient eligibility for these kinds of transplants, Dr. Larsen said, and weight can be a complicating factor. The drugs used in transplants in patients with higher body mass indexes exacerbate insulin resistance, Dr. Larsen said, “and that will make it harder to manage afterward. We haven’t worked out if BMI affects graft function over time.”
Reduced cardiac function eliminates simultaneous pancreas/kidney (SPK) transplants as an option for patients with diabetes, while blindness, severe hypoglycemia unawareness, and other autonomic neuropathies can make SPK more appropriate. Gastroparesis, meanwhile, can be an issue for all transplants.
Dr. Larsen’s own research has suggested that SPK transplants can be better than kidney transplant alone in terms of improving neuropathy, symptoms of peripheral neuropathy, and, perhaps, gastroparesis symptoms. However, SPK is not better in terms of improving bladder neuropathy, eye disease, amputations, and cardiac complications of diabetes (Endocr Rev. 2004;25[6]:919-46).
While the prognosis for transplants in diabetes patients is often promising Dr. Larsen cautioned that there can still be a big obstacle: Primary care physicians who fail to act.
“Most diabetes patients are not managed by endocrinologists,” she said, “and there are still many primary care physicians who delay referral to transplant teams for their diabetes patients or even to endocrinologists when they are struggling with diabetes management.”
Dr. Larsen reports no relevant disclosures.
SAN DIEGO – The risks for patients with diabetes who face organ transplants have diminished greatly, according to an endocrinologist.
But there are still many limitations for these patients – some transplants are not appropriate for patients with diabetes – and there are potential complications when they do get transplants.
“While it used to be that outcomes were worse in patients with diabetes, such as more infections and higher mortality, this has become much less so over time, because of team-based care and better focus on diabetes management postoperatively,” said Jennifer Larsen, MD. Still, “the complexities come with the variable other factors and conditions the patient might have, such as autonomic neuropathies, the sudden variations in kidney function that can occur before and after transplant, and the impact of the transplant medications on other aspects of diabetes care such as lipid management and metabolism of other drugs.”
“They also take care of diabetes patients who get other types of transplant such as heart transplant, liver, and lung,” said Dr. Larsen, vice chancellor for research and professor of internal medicine at University of Nebraska Medical Center, Omaha.
And, she added, they take care of patients who develop diabetes after transplants – posttransplant diabetes. “So it’s important to the endocrinologist today to be familiar with the transplant world, the medicines used, and how chronic kidney disease impacts diabetes management,” she said.
Endocrinologists serve in a variety of roles when patients need transplants, she added. “In some cases the transplant surgeon is referring to us, the endocrinologist. If the patient is heading toward kidney transplant in particular, the pancreas and islet options with kidney transplants would all be handled by the transplant nephrologists, who work hand in hand with the transplant surgeons. Some endocrinologists are embedded in these teams, too.”
Patients with diabetes complicated by chronic kidney disease may be eligible for a transplant of a kidney – in line with the adage that “any kidney is better than dialysis,” Dr. Larsen said – or kidney/pancreas or kidney/islet transplants.
Kidney/pancreas and kidney/islet transplants may be performed simultaneously or with the kidney transplant first. However, islet transplants are not appropriate for patients with type 2 diabetes, and these patients also may not be eligible for simultaneous kidney/pancreas transplants.
According to the United Network for Organ Sharing, there were more than 415,075 kidney transplants from Jan. 1, 1988, to June 30, 2017 (www.unos.org/data). The numbers for pancreas and kidney/pancreas transplants are 8,462 and 22,496, respectively. Islet transplant numbers were not available.
Five-year patient survival rates for kidney transplants are 85%, and graft survival rates are 71%, Dr. Larsen said, and they’re similar for kidney/pancreas transplants. According to Dr. Larsen, patient survival is lower after islet transplantation.
Adjusted patient and graft survival rates in kidney transplants are the same among nondiabetic patients and those with diabetes (Nephrol Dial Transplant. 2002.17[9]:1678-83).
Diabetes complications can affect patient eligibility for these kinds of transplants, Dr. Larsen said, and weight can be a complicating factor. The drugs used in transplants in patients with higher body mass indexes exacerbate insulin resistance, Dr. Larsen said, “and that will make it harder to manage afterward. We haven’t worked out if BMI affects graft function over time.”
Reduced cardiac function eliminates simultaneous pancreas/kidney (SPK) transplants as an option for patients with diabetes, while blindness, severe hypoglycemia unawareness, and other autonomic neuropathies can make SPK more appropriate. Gastroparesis, meanwhile, can be an issue for all transplants.
Dr. Larsen’s own research has suggested that SPK transplants can be better than kidney transplant alone in terms of improving neuropathy, symptoms of peripheral neuropathy, and, perhaps, gastroparesis symptoms. However, SPK is not better in terms of improving bladder neuropathy, eye disease, amputations, and cardiac complications of diabetes (Endocr Rev. 2004;25[6]:919-46).
While the prognosis for transplants in diabetes patients is often promising Dr. Larsen cautioned that there can still be a big obstacle: Primary care physicians who fail to act.
“Most diabetes patients are not managed by endocrinologists,” she said, “and there are still many primary care physicians who delay referral to transplant teams for their diabetes patients or even to endocrinologists when they are struggling with diabetes management.”
Dr. Larsen reports no relevant disclosures.
SAN DIEGO – The risks for patients with diabetes who face organ transplants have diminished greatly, according to an endocrinologist.
But there are still many limitations for these patients – some transplants are not appropriate for patients with diabetes – and there are potential complications when they do get transplants.
“While it used to be that outcomes were worse in patients with diabetes, such as more infections and higher mortality, this has become much less so over time, because of team-based care and better focus on diabetes management postoperatively,” said Jennifer Larsen, MD. Still, “the complexities come with the variable other factors and conditions the patient might have, such as autonomic neuropathies, the sudden variations in kidney function that can occur before and after transplant, and the impact of the transplant medications on other aspects of diabetes care such as lipid management and metabolism of other drugs.”
“They also take care of diabetes patients who get other types of transplant such as heart transplant, liver, and lung,” said Dr. Larsen, vice chancellor for research and professor of internal medicine at University of Nebraska Medical Center, Omaha.
And, she added, they take care of patients who develop diabetes after transplants – posttransplant diabetes. “So it’s important to the endocrinologist today to be familiar with the transplant world, the medicines used, and how chronic kidney disease impacts diabetes management,” she said.
Endocrinologists serve in a variety of roles when patients need transplants, she added. “In some cases the transplant surgeon is referring to us, the endocrinologist. If the patient is heading toward kidney transplant in particular, the pancreas and islet options with kidney transplants would all be handled by the transplant nephrologists, who work hand in hand with the transplant surgeons. Some endocrinologists are embedded in these teams, too.”
Patients with diabetes complicated by chronic kidney disease may be eligible for a transplant of a kidney – in line with the adage that “any kidney is better than dialysis,” Dr. Larsen said – or kidney/pancreas or kidney/islet transplants.
Kidney/pancreas and kidney/islet transplants may be performed simultaneously or with the kidney transplant first. However, islet transplants are not appropriate for patients with type 2 diabetes, and these patients also may not be eligible for simultaneous kidney/pancreas transplants.
According to the United Network for Organ Sharing, there were more than 415,075 kidney transplants from Jan. 1, 1988, to June 30, 2017 (www.unos.org/data). The numbers for pancreas and kidney/pancreas transplants are 8,462 and 22,496, respectively. Islet transplant numbers were not available.
Five-year patient survival rates for kidney transplants are 85%, and graft survival rates are 71%, Dr. Larsen said, and they’re similar for kidney/pancreas transplants. According to Dr. Larsen, patient survival is lower after islet transplantation.
Adjusted patient and graft survival rates in kidney transplants are the same among nondiabetic patients and those with diabetes (Nephrol Dial Transplant. 2002.17[9]:1678-83).
Diabetes complications can affect patient eligibility for these kinds of transplants, Dr. Larsen said, and weight can be a complicating factor. The drugs used in transplants in patients with higher body mass indexes exacerbate insulin resistance, Dr. Larsen said, “and that will make it harder to manage afterward. We haven’t worked out if BMI affects graft function over time.”
Reduced cardiac function eliminates simultaneous pancreas/kidney (SPK) transplants as an option for patients with diabetes, while blindness, severe hypoglycemia unawareness, and other autonomic neuropathies can make SPK more appropriate. Gastroparesis, meanwhile, can be an issue for all transplants.
Dr. Larsen’s own research has suggested that SPK transplants can be better than kidney transplant alone in terms of improving neuropathy, symptoms of peripheral neuropathy, and, perhaps, gastroparesis symptoms. However, SPK is not better in terms of improving bladder neuropathy, eye disease, amputations, and cardiac complications of diabetes (Endocr Rev. 2004;25[6]:919-46).
While the prognosis for transplants in diabetes patients is often promising Dr. Larsen cautioned that there can still be a big obstacle: Primary care physicians who fail to act.
“Most diabetes patients are not managed by endocrinologists,” she said, “and there are still many primary care physicians who delay referral to transplant teams for their diabetes patients or even to endocrinologists when they are struggling with diabetes management.”
Dr. Larsen reports no relevant disclosures.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Exercise, CBT linked to higher drop in depression in type 2 diabetes
SAN DIEGO – The odds of full remission from clinically diagnosed major depression greatly improved in patients with type 2 diabetes who took part in 12-week supervised exercise and cognitive behavioral therapy (CBT). By the end of the study, 96% of the CBT participants no longer met diagnostic criteria for major depression, compared with just 65% of those on usual care, judging from the findings of a new study.
Another approach – a combination treatment of both exercise and CBT therapies – did not show a statistically significant effect on full remission rates but showed improvement in some other areas.
Dr. De Groot and her colleagues recruited 140 adults – mean age 57 years, 77% female, 71% white, 52% married – who had a diagnosis of both type 2 diabetes and diagnosed clinical depression. They came from three states and had various levels of income and educational background.
The researchers randomly assigned the participants to usual care, 12 weeks of exercise with a personal trainer, 10 individual CBT sessions, or a combination of both exercise and CBT therapies. There were 34-36 participants in each group.
The researchers found improvements in depressive symptoms (P less than .05); negative automatic thoughts (P less than .03), and diabetes distress (P less than .01) and physical quality of life (P less than .03 for all except P greater than 0.1 for CBT) for all three intervention groups compared with usual care. Diabetes-specific quality of life improved in the exercise and combination groups only (P less than .01).
The researchers calculated odds ratios of full or partial remission as 12.4 (CBT) and 5.8 (exercise) compared to usual care (P less than .03), controlling for changes in antidepressant drugs. However, the odds ratio for combination therapy was 2.3 and not deemed statistically significant (P = .218).
The researchers also examined results in subjects with a baseline hemoglobin A1c of 7% or higher and found evidence linking the exercise therapy to clinically meaningful 0.7% improvements in HbA1c (P less than .04).
It’s also not clear whether the interventions will hold up over the long term.
The National Institutes of Health–National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. De Groot reported no relevant disclosures.
SAN DIEGO – The odds of full remission from clinically diagnosed major depression greatly improved in patients with type 2 diabetes who took part in 12-week supervised exercise and cognitive behavioral therapy (CBT). By the end of the study, 96% of the CBT participants no longer met diagnostic criteria for major depression, compared with just 65% of those on usual care, judging from the findings of a new study.
Another approach – a combination treatment of both exercise and CBT therapies – did not show a statistically significant effect on full remission rates but showed improvement in some other areas.
Dr. De Groot and her colleagues recruited 140 adults – mean age 57 years, 77% female, 71% white, 52% married – who had a diagnosis of both type 2 diabetes and diagnosed clinical depression. They came from three states and had various levels of income and educational background.
The researchers randomly assigned the participants to usual care, 12 weeks of exercise with a personal trainer, 10 individual CBT sessions, or a combination of both exercise and CBT therapies. There were 34-36 participants in each group.
The researchers found improvements in depressive symptoms (P less than .05); negative automatic thoughts (P less than .03), and diabetes distress (P less than .01) and physical quality of life (P less than .03 for all except P greater than 0.1 for CBT) for all three intervention groups compared with usual care. Diabetes-specific quality of life improved in the exercise and combination groups only (P less than .01).
The researchers calculated odds ratios of full or partial remission as 12.4 (CBT) and 5.8 (exercise) compared to usual care (P less than .03), controlling for changes in antidepressant drugs. However, the odds ratio for combination therapy was 2.3 and not deemed statistically significant (P = .218).
The researchers also examined results in subjects with a baseline hemoglobin A1c of 7% or higher and found evidence linking the exercise therapy to clinically meaningful 0.7% improvements in HbA1c (P less than .04).
It’s also not clear whether the interventions will hold up over the long term.
The National Institutes of Health–National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. De Groot reported no relevant disclosures.
SAN DIEGO – The odds of full remission from clinically diagnosed major depression greatly improved in patients with type 2 diabetes who took part in 12-week supervised exercise and cognitive behavioral therapy (CBT). By the end of the study, 96% of the CBT participants no longer met diagnostic criteria for major depression, compared with just 65% of those on usual care, judging from the findings of a new study.
Another approach – a combination treatment of both exercise and CBT therapies – did not show a statistically significant effect on full remission rates but showed improvement in some other areas.
Dr. De Groot and her colleagues recruited 140 adults – mean age 57 years, 77% female, 71% white, 52% married – who had a diagnosis of both type 2 diabetes and diagnosed clinical depression. They came from three states and had various levels of income and educational background.
The researchers randomly assigned the participants to usual care, 12 weeks of exercise with a personal trainer, 10 individual CBT sessions, or a combination of both exercise and CBT therapies. There were 34-36 participants in each group.
The researchers found improvements in depressive symptoms (P less than .05); negative automatic thoughts (P less than .03), and diabetes distress (P less than .01) and physical quality of life (P less than .03 for all except P greater than 0.1 for CBT) for all three intervention groups compared with usual care. Diabetes-specific quality of life improved in the exercise and combination groups only (P less than .01).
The researchers calculated odds ratios of full or partial remission as 12.4 (CBT) and 5.8 (exercise) compared to usual care (P less than .03), controlling for changes in antidepressant drugs. However, the odds ratio for combination therapy was 2.3 and not deemed statistically significant (P = .218).
The researchers also examined results in subjects with a baseline hemoglobin A1c of 7% or higher and found evidence linking the exercise therapy to clinically meaningful 0.7% improvements in HbA1c (P less than .04).
It’s also not clear whether the interventions will hold up over the long term.
The National Institutes of Health–National Institute of Diabetes and Digestive and Kidney Diseases funded the study. Dr. De Groot reported no relevant disclosures.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Supervised exercise and cognitive behavioral therapies are linked to higher rates of recovery from major depression at 12 weeks in patients with type 2 diabetes.
Major finding: Full or partial remission was more likely in CBT and exercise groups compared with usual care after researchers controlled for changes in antidepressant drugs.
Data source: Prospective study of 140 adults with type 2 diabetes randomly assigned to 12 weeks of exercise with a physical trainer, 10 individual CBT sessions, a combination of the two therapies, or usual care.
Disclosures: The National Institutes of Health–National Institute of Diabetes and Digestive and Kidney Diseases funded the study.
Coping when a patient commits suicide
SAN DIEGO – Most psychiatrists raised their hands in a conference room at the annual meeting of the American Psychiatric Association when a presenter asked whether they’d ever had a patient die from suicide. Moments later, one rose and described her own devastating experience with a patient who killed himself.
“We’d talked for 100 nights over 12 years. If a call came in at night, I knew who it was,” she said. Then he committed suicide, forcing her to question her assumptions about her ability to help others.
“I had this unconscious fantasy that I could will people to keep on living,” she said.
“We spend so much time with our patients,” added another audience member, that “it’s almost like a family member dying. Just overwhelming sadness.”
A 2015 meta-analysis estimated that there is 1 suicide for every 676 inpatient admissions, and a 20-year prospective study found that 1% of 6,891 psychiatric outpatients committed suicide (Acta Psychiatr Scand. 2015 Mar;131[3]:174-84), (J Consult Clin Psychol. 2000 Jun;68[3]:371-7).
To make things more complex for psychiatrists, suicides and attempted suicides are frequent triggers for malpractice suits, accounting for 5.4% overall and 17% of those directed at psychiatrists, said psychologist and copresenter Jane Tillman, PhD, director of the Erikson Institute for Education and Research of the Austen Riggs Center in Stockbridge, Mass., and assistant clinical professor at the Yale Child Study Center in New Haven, Conn. (However, a 2014 U.S. study found that “in malpractice, psychiatry accounted for a small percentage of overall claims and settlements” (Ann Clin Psychiatry. 2014 May;26[2]:91-6).
“They spoke to me about affective experiences like feeling incredibly sad. Some felt angry and rageful,” Dr. Tillman told the APA audience. “One young therapist, a trainee, told me that her patient’s father called to tell her the patient had died by suicide. ‘After I spoke to the patient’s father,’ the therapist recalled, ‘the mother got onto the phone and screamed. I broke down and started crying. Hearing the sound of a mother who had lost her child went right through me.’ ”
Another therapist felt “angry at everyone” and guilty, too, after a patient killed herself without calling for help. And Dr. Tillman heard from therapists who worried about their professional lives, how they’d be viewed, and whether they’d be cut off from their peers.
“I had the sense of people pulling away from me and me pulling away from them,” one therapist told Dr. Tillman. “Some reached out to me early but they didn’t follow through, and I didn’t follow through.”
Young therapists face unique challenges, Dr. Tillman said. “They felt foolish, as if they’d been grandiose,” she said. “They pathologize hope.”
Copresenter Dr. Plakun, associate medical director and director of biopsychosocial advocacy at Austen Riggs, offered these tips to psychiatrists:
• Support colleagues whose patients kill themselves. “Convene and participate in a nonjudgmental review of the suicide. Be there, try to be part of this discussion, share your own experiences. And [be] aware of the inevitability of countertransference of guilt, anger, and blaming.”
• “If you are the person who had a patient die by suicide, avoid isolation; call your insurance carrier for consultation about risk management issues, and prepare yourself for contact with the family.”
• Take special care before meetings with family: Understand the confidentiality issues and remember where the focus belongs. “You’re there to meet the family’s needs, not yours primarily. There’s no reason to castigate yourself and take blame. But that doesn’t mean you can’t express genuine sorrow about the loss.”
• Seek professional support and focus on self-care. “Try to preserve a space in our families and in our personal friendships where we can continue to live our lives and not be haunted by these things in our relationships with partners, spouses, children. And we need to grieve well. It’s a terrible loss, and it’s something that we need to pay attention to and take seriously.”
Dr. Plakun and Dr. Tillman reported no relevant disclosures.
SAN DIEGO – Most psychiatrists raised their hands in a conference room at the annual meeting of the American Psychiatric Association when a presenter asked whether they’d ever had a patient die from suicide. Moments later, one rose and described her own devastating experience with a patient who killed himself.
“We’d talked for 100 nights over 12 years. If a call came in at night, I knew who it was,” she said. Then he committed suicide, forcing her to question her assumptions about her ability to help others.
“I had this unconscious fantasy that I could will people to keep on living,” she said.
“We spend so much time with our patients,” added another audience member, that “it’s almost like a family member dying. Just overwhelming sadness.”
A 2015 meta-analysis estimated that there is 1 suicide for every 676 inpatient admissions, and a 20-year prospective study found that 1% of 6,891 psychiatric outpatients committed suicide (Acta Psychiatr Scand. 2015 Mar;131[3]:174-84), (J Consult Clin Psychol. 2000 Jun;68[3]:371-7).
To make things more complex for psychiatrists, suicides and attempted suicides are frequent triggers for malpractice suits, accounting for 5.4% overall and 17% of those directed at psychiatrists, said psychologist and copresenter Jane Tillman, PhD, director of the Erikson Institute for Education and Research of the Austen Riggs Center in Stockbridge, Mass., and assistant clinical professor at the Yale Child Study Center in New Haven, Conn. (However, a 2014 U.S. study found that “in malpractice, psychiatry accounted for a small percentage of overall claims and settlements” (Ann Clin Psychiatry. 2014 May;26[2]:91-6).
“They spoke to me about affective experiences like feeling incredibly sad. Some felt angry and rageful,” Dr. Tillman told the APA audience. “One young therapist, a trainee, told me that her patient’s father called to tell her the patient had died by suicide. ‘After I spoke to the patient’s father,’ the therapist recalled, ‘the mother got onto the phone and screamed. I broke down and started crying. Hearing the sound of a mother who had lost her child went right through me.’ ”
Another therapist felt “angry at everyone” and guilty, too, after a patient killed herself without calling for help. And Dr. Tillman heard from therapists who worried about their professional lives, how they’d be viewed, and whether they’d be cut off from their peers.
“I had the sense of people pulling away from me and me pulling away from them,” one therapist told Dr. Tillman. “Some reached out to me early but they didn’t follow through, and I didn’t follow through.”
Young therapists face unique challenges, Dr. Tillman said. “They felt foolish, as if they’d been grandiose,” she said. “They pathologize hope.”
Copresenter Dr. Plakun, associate medical director and director of biopsychosocial advocacy at Austen Riggs, offered these tips to psychiatrists:
• Support colleagues whose patients kill themselves. “Convene and participate in a nonjudgmental review of the suicide. Be there, try to be part of this discussion, share your own experiences. And [be] aware of the inevitability of countertransference of guilt, anger, and blaming.”
• “If you are the person who had a patient die by suicide, avoid isolation; call your insurance carrier for consultation about risk management issues, and prepare yourself for contact with the family.”
• Take special care before meetings with family: Understand the confidentiality issues and remember where the focus belongs. “You’re there to meet the family’s needs, not yours primarily. There’s no reason to castigate yourself and take blame. But that doesn’t mean you can’t express genuine sorrow about the loss.”
• Seek professional support and focus on self-care. “Try to preserve a space in our families and in our personal friendships where we can continue to live our lives and not be haunted by these things in our relationships with partners, spouses, children. And we need to grieve well. It’s a terrible loss, and it’s something that we need to pay attention to and take seriously.”
Dr. Plakun and Dr. Tillman reported no relevant disclosures.
SAN DIEGO – Most psychiatrists raised their hands in a conference room at the annual meeting of the American Psychiatric Association when a presenter asked whether they’d ever had a patient die from suicide. Moments later, one rose and described her own devastating experience with a patient who killed himself.
“We’d talked for 100 nights over 12 years. If a call came in at night, I knew who it was,” she said. Then he committed suicide, forcing her to question her assumptions about her ability to help others.
“I had this unconscious fantasy that I could will people to keep on living,” she said.
“We spend so much time with our patients,” added another audience member, that “it’s almost like a family member dying. Just overwhelming sadness.”
A 2015 meta-analysis estimated that there is 1 suicide for every 676 inpatient admissions, and a 20-year prospective study found that 1% of 6,891 psychiatric outpatients committed suicide (Acta Psychiatr Scand. 2015 Mar;131[3]:174-84), (J Consult Clin Psychol. 2000 Jun;68[3]:371-7).
To make things more complex for psychiatrists, suicides and attempted suicides are frequent triggers for malpractice suits, accounting for 5.4% overall and 17% of those directed at psychiatrists, said psychologist and copresenter Jane Tillman, PhD, director of the Erikson Institute for Education and Research of the Austen Riggs Center in Stockbridge, Mass., and assistant clinical professor at the Yale Child Study Center in New Haven, Conn. (However, a 2014 U.S. study found that “in malpractice, psychiatry accounted for a small percentage of overall claims and settlements” (Ann Clin Psychiatry. 2014 May;26[2]:91-6).
“They spoke to me about affective experiences like feeling incredibly sad. Some felt angry and rageful,” Dr. Tillman told the APA audience. “One young therapist, a trainee, told me that her patient’s father called to tell her the patient had died by suicide. ‘After I spoke to the patient’s father,’ the therapist recalled, ‘the mother got onto the phone and screamed. I broke down and started crying. Hearing the sound of a mother who had lost her child went right through me.’ ”
Another therapist felt “angry at everyone” and guilty, too, after a patient killed herself without calling for help. And Dr. Tillman heard from therapists who worried about their professional lives, how they’d be viewed, and whether they’d be cut off from their peers.
“I had the sense of people pulling away from me and me pulling away from them,” one therapist told Dr. Tillman. “Some reached out to me early but they didn’t follow through, and I didn’t follow through.”
Young therapists face unique challenges, Dr. Tillman said. “They felt foolish, as if they’d been grandiose,” she said. “They pathologize hope.”
Copresenter Dr. Plakun, associate medical director and director of biopsychosocial advocacy at Austen Riggs, offered these tips to psychiatrists:
• Support colleagues whose patients kill themselves. “Convene and participate in a nonjudgmental review of the suicide. Be there, try to be part of this discussion, share your own experiences. And [be] aware of the inevitability of countertransference of guilt, anger, and blaming.”
• “If you are the person who had a patient die by suicide, avoid isolation; call your insurance carrier for consultation about risk management issues, and prepare yourself for contact with the family.”
• Take special care before meetings with family: Understand the confidentiality issues and remember where the focus belongs. “You’re there to meet the family’s needs, not yours primarily. There’s no reason to castigate yourself and take blame. But that doesn’t mean you can’t express genuine sorrow about the loss.”
• Seek professional support and focus on self-care. “Try to preserve a space in our families and in our personal friendships where we can continue to live our lives and not be haunted by these things in our relationships with partners, spouses, children. And we need to grieve well. It’s a terrible loss, and it’s something that we need to pay attention to and take seriously.”
Dr. Plakun and Dr. Tillman reported no relevant disclosures.
AT APA
Statins linked to fewer deaths, slightly higher HbA1c in T2DM
SAN DIEGO – Findings from a study of 12,725 new insulin users with type 2 diabetes mellitus (T2DM) show that those who did not take statins were slightly better able to control their blood sugar, but those who used the cholesterol-lowering drugs lived longer and had fewer cardiac events.
“It is clear that, in this high-risk population, the benefits of statins on cardiovascular outcomes outweigh the small adverse metabolic effects on glycemic control,” study lead author Uche Anyanwagu, MBBS, MSc, a graduate student and research fellow at the University of Nottingham (England), said in an interview about his data presented in a poster at the annual scientific sessions of the American Diabetes Association.
However, “there remain great concerns about statins and their modest adverse effects on glucose and insulin metabolism in increasing the risk of new-onset diabetes or worsening glycemic control, especially in higher doses and with the more potent statins,” Dr. Anyanwagu said. “Very little is known about the relationship between statin use and glycemic control in patients with established T2DM.”
The study authors retrospectively analyzed medical records of 12,725 new insulin users with T2DM from a British primary care database. “The commencement of insulin represents a group of patients with T2DM with longer disease duration and more complex needs, many of whom have other comorbid illnesses,” Dr. Anyanwagu said.
The average age of the subjects was 58.6 years (standard deviation, 13.8), and 50% were female (P less than 0.001 for both). Their average HbA1c level was 8.7 (SD, 1.8; P = .556), and 63% were obese.
The numbers of statin users and nonstatin users were 10,682 and 2,043, respectively. Researchers found that the statin users performed better in measures of all-cause mortality, nonfatal stroke, and a composite outcome measure but not in acute myocardial infarction.
In all-cause mortality, the absolute rate over 5 years was 9.5 deaths per 1,000 person years (95% confidence interval, 8.7-10.5) for statin users and 24.9 (95% CI, 21.5-28.9) for nonusers. After adjustment for age, gender, duration of insulin use, albumin, glomerular filtration rate, lipid profile, and coronary heart disease, the hazard ratio was 1.89 (95% CI, 1.51-2.37) for nonusers, compared with a reference of 1 for users. (P less than .0001).
The absolute rate for a composite outcome – encompassing measures of all-cause mortality, nonfatal acute myocardial infarction, and nonfatal stroke – was 20.7 (95% CI, 19.3-22.1) for statin users and 30.9 (95% CI , 27-35.3) for nonusers (P less than .0001).
As for HbA1c levels, at 12 months, they’d fallen by an average of 0.29% in the statin group and 0.37% in the nonuser group (P = .021). At 36 months, there was a smaller difference (–0.31% vs. –0.35%, respectively), and it wasn’t statistically significant (P = .344).
The study was funded by the University of Nottingham. (England). Dr. Anyanwagu reports no relevant disclosures.
SAN DIEGO – Findings from a study of 12,725 new insulin users with type 2 diabetes mellitus (T2DM) show that those who did not take statins were slightly better able to control their blood sugar, but those who used the cholesterol-lowering drugs lived longer and had fewer cardiac events.
“It is clear that, in this high-risk population, the benefits of statins on cardiovascular outcomes outweigh the small adverse metabolic effects on glycemic control,” study lead author Uche Anyanwagu, MBBS, MSc, a graduate student and research fellow at the University of Nottingham (England), said in an interview about his data presented in a poster at the annual scientific sessions of the American Diabetes Association.
However, “there remain great concerns about statins and their modest adverse effects on glucose and insulin metabolism in increasing the risk of new-onset diabetes or worsening glycemic control, especially in higher doses and with the more potent statins,” Dr. Anyanwagu said. “Very little is known about the relationship between statin use and glycemic control in patients with established T2DM.”
The study authors retrospectively analyzed medical records of 12,725 new insulin users with T2DM from a British primary care database. “The commencement of insulin represents a group of patients with T2DM with longer disease duration and more complex needs, many of whom have other comorbid illnesses,” Dr. Anyanwagu said.
The average age of the subjects was 58.6 years (standard deviation, 13.8), and 50% were female (P less than 0.001 for both). Their average HbA1c level was 8.7 (SD, 1.8; P = .556), and 63% were obese.
The numbers of statin users and nonstatin users were 10,682 and 2,043, respectively. Researchers found that the statin users performed better in measures of all-cause mortality, nonfatal stroke, and a composite outcome measure but not in acute myocardial infarction.
In all-cause mortality, the absolute rate over 5 years was 9.5 deaths per 1,000 person years (95% confidence interval, 8.7-10.5) for statin users and 24.9 (95% CI, 21.5-28.9) for nonusers. After adjustment for age, gender, duration of insulin use, albumin, glomerular filtration rate, lipid profile, and coronary heart disease, the hazard ratio was 1.89 (95% CI, 1.51-2.37) for nonusers, compared with a reference of 1 for users. (P less than .0001).
The absolute rate for a composite outcome – encompassing measures of all-cause mortality, nonfatal acute myocardial infarction, and nonfatal stroke – was 20.7 (95% CI, 19.3-22.1) for statin users and 30.9 (95% CI , 27-35.3) for nonusers (P less than .0001).
As for HbA1c levels, at 12 months, they’d fallen by an average of 0.29% in the statin group and 0.37% in the nonuser group (P = .021). At 36 months, there was a smaller difference (–0.31% vs. –0.35%, respectively), and it wasn’t statistically significant (P = .344).
The study was funded by the University of Nottingham. (England). Dr. Anyanwagu reports no relevant disclosures.
SAN DIEGO – Findings from a study of 12,725 new insulin users with type 2 diabetes mellitus (T2DM) show that those who did not take statins were slightly better able to control their blood sugar, but those who used the cholesterol-lowering drugs lived longer and had fewer cardiac events.
“It is clear that, in this high-risk population, the benefits of statins on cardiovascular outcomes outweigh the small adverse metabolic effects on glycemic control,” study lead author Uche Anyanwagu, MBBS, MSc, a graduate student and research fellow at the University of Nottingham (England), said in an interview about his data presented in a poster at the annual scientific sessions of the American Diabetes Association.
However, “there remain great concerns about statins and their modest adverse effects on glucose and insulin metabolism in increasing the risk of new-onset diabetes or worsening glycemic control, especially in higher doses and with the more potent statins,” Dr. Anyanwagu said. “Very little is known about the relationship between statin use and glycemic control in patients with established T2DM.”
The study authors retrospectively analyzed medical records of 12,725 new insulin users with T2DM from a British primary care database. “The commencement of insulin represents a group of patients with T2DM with longer disease duration and more complex needs, many of whom have other comorbid illnesses,” Dr. Anyanwagu said.
The average age of the subjects was 58.6 years (standard deviation, 13.8), and 50% were female (P less than 0.001 for both). Their average HbA1c level was 8.7 (SD, 1.8; P = .556), and 63% were obese.
The numbers of statin users and nonstatin users were 10,682 and 2,043, respectively. Researchers found that the statin users performed better in measures of all-cause mortality, nonfatal stroke, and a composite outcome measure but not in acute myocardial infarction.
In all-cause mortality, the absolute rate over 5 years was 9.5 deaths per 1,000 person years (95% confidence interval, 8.7-10.5) for statin users and 24.9 (95% CI, 21.5-28.9) for nonusers. After adjustment for age, gender, duration of insulin use, albumin, glomerular filtration rate, lipid profile, and coronary heart disease, the hazard ratio was 1.89 (95% CI, 1.51-2.37) for nonusers, compared with a reference of 1 for users. (P less than .0001).
The absolute rate for a composite outcome – encompassing measures of all-cause mortality, nonfatal acute myocardial infarction, and nonfatal stroke – was 20.7 (95% CI, 19.3-22.1) for statin users and 30.9 (95% CI , 27-35.3) for nonusers (P less than .0001).
As for HbA1c levels, at 12 months, they’d fallen by an average of 0.29% in the statin group and 0.37% in the nonuser group (P = .021). At 36 months, there was a smaller difference (–0.31% vs. –0.35%, respectively), and it wasn’t statistically significant (P = .344).
The study was funded by the University of Nottingham. (England). Dr. Anyanwagu reports no relevant disclosures.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: In new insulin users with T2DM, statin use appears to slightly lower the decline in HbA1c, compared with nonuse, but the drug improved all-cause mortality.
Major finding: The adjusted hazard ratio of 5-year all-cause mortality was 1.89 in nonstatin users, vs. a reference of 1 for statin users. At 12 months, HbA1c fell by an average of 0.29% in the statin group and 0.37% in the nonuser group, but the difference wasn’t statistically significant at 36 months.
Data source: A retrospective study of 10,682 stain users and 2,043 nonusers, all of whom were new insulin users, from a British primary care database.
Disclosures: The study was funded by the University of Nottingham (England).
Nearly half of patients who stop taking opioids for 6 months resume use later
SAN DIEGO – A new study of medical records offers insights into the persistence of opioid use: Most patients who were prescribed opioid painkillers did not go back for a refill right away, but nearly half of patients who stopped taking the drugs for at least 6 months ended up using them again over a 3-year period.
“This key finding indicates that programs that address opioid use need to focus on long-term support and education to ensure that individuals do not become long-term users,” psychiatrist and lead author Shareh Ghani, MD, vice president and medical director of Magellan Health Services, San Francisco, said in an interview.
Researchers also found that opioid use appeared linked to three unexpected conditions – lipid disorders, hypertension, and sleep-wake disorders – and found that more than half of those who had at least two prescriptions for high-dose opioids kept taking the drugs over 18 months after an initial 90-day period.
Dr. Ghani and his colleague, Gowri Shetty, MPH, analyzed medical and pharmacy data from 2009-2012 for 2.5 million people. The participants, aged 20-64 years, came from across the United States and were part of a commercial health plan.
The researchers found that 21% had received one prescription for an opioid. Users considered at risk for persistent use – more than one prescription over 3 years – were more likely than were nonusers to have these characteristics: spondylosis and other back problems (odds ratio, 5.3), substance-related and addictive disorders (OR, 4.6), sleep-wake disorders (OR, 2.2), depressive disorders (OR, 1.7), headaches (OR, 2.1), and anxiety disorders (OR, 1.5.) The P values for all of those characteristics were less than .001.
They also found that patients who received certain kinds of treatment were at higher risk, compared with nonusers: those who were treated for substance abuse treatment (OR, 4.5), in emergency departments (OR, 3.2), with anesthesia (OR, 4.2), for mental health issues (OR, 2.3), and with surgery (OR, 2.0). The P values for all of those characteristics also were less than .001.
“The unexpected findings were the presence of lipid disorders, hypertension, and sleep-wake disorders. These diagnoses were not found in other literature,” Dr. Ghani said in an interview. “These conditions, however, are related to others that are known. For instance, a person with knee joint pain who is overweight – a known risk factor – may also have hypertension and lipid disorders.”
The researchers also discovered that 80% of patients who received an opioid prescription did not get a refill. Of those who had at least two prescriptions and a stable dose over an initial 90 days, 14% went on to have more prescriptions and a boost in dosage over 18 months, while 12% stayed the same and almost 74% took less.
But the situation was different for those with at least two prescriptions and a high dose (more than 120 mg) over an initial 90 days: 56% of them stayed at that level over 18 months.
The researchers also found that 48% of those who had stopped using opioids for at least 6 months went on to use them again. This high rate “suggests that physicians and patients need to be aware of the high risk of dependence and addiction for some individuals,” Dr. Ghani said. “Studying prescription fill behaviors and the persistence of prescription opioid users helps identify individuals at high risk for persistent use and may provide a better understanding of how to target interventions for inappropriate opioid use.”
The study has limitations. It does not indicate whether patients became substance abusers, nor does it provide details about opioids obtained illegally. Still, “we do know from literature and clinical experience that staying on prescription opioids may lead to dependence, escalation of dose, and increased risk of developing addictions that can lead to using street drugs like heroin,” Dr. Ghani said.
Magellan funded the study. Dr. Ghani reported no additional disclosures.
SAN DIEGO – A new study of medical records offers insights into the persistence of opioid use: Most patients who were prescribed opioid painkillers did not go back for a refill right away, but nearly half of patients who stopped taking the drugs for at least 6 months ended up using them again over a 3-year period.
“This key finding indicates that programs that address opioid use need to focus on long-term support and education to ensure that individuals do not become long-term users,” psychiatrist and lead author Shareh Ghani, MD, vice president and medical director of Magellan Health Services, San Francisco, said in an interview.
Researchers also found that opioid use appeared linked to three unexpected conditions – lipid disorders, hypertension, and sleep-wake disorders – and found that more than half of those who had at least two prescriptions for high-dose opioids kept taking the drugs over 18 months after an initial 90-day period.
Dr. Ghani and his colleague, Gowri Shetty, MPH, analyzed medical and pharmacy data from 2009-2012 for 2.5 million people. The participants, aged 20-64 years, came from across the United States and were part of a commercial health plan.
The researchers found that 21% had received one prescription for an opioid. Users considered at risk for persistent use – more than one prescription over 3 years – were more likely than were nonusers to have these characteristics: spondylosis and other back problems (odds ratio, 5.3), substance-related and addictive disorders (OR, 4.6), sleep-wake disorders (OR, 2.2), depressive disorders (OR, 1.7), headaches (OR, 2.1), and anxiety disorders (OR, 1.5.) The P values for all of those characteristics were less than .001.
They also found that patients who received certain kinds of treatment were at higher risk, compared with nonusers: those who were treated for substance abuse treatment (OR, 4.5), in emergency departments (OR, 3.2), with anesthesia (OR, 4.2), for mental health issues (OR, 2.3), and with surgery (OR, 2.0). The P values for all of those characteristics also were less than .001.
“The unexpected findings were the presence of lipid disorders, hypertension, and sleep-wake disorders. These diagnoses were not found in other literature,” Dr. Ghani said in an interview. “These conditions, however, are related to others that are known. For instance, a person with knee joint pain who is overweight – a known risk factor – may also have hypertension and lipid disorders.”
The researchers also discovered that 80% of patients who received an opioid prescription did not get a refill. Of those who had at least two prescriptions and a stable dose over an initial 90 days, 14% went on to have more prescriptions and a boost in dosage over 18 months, while 12% stayed the same and almost 74% took less.
But the situation was different for those with at least two prescriptions and a high dose (more than 120 mg) over an initial 90 days: 56% of them stayed at that level over 18 months.
The researchers also found that 48% of those who had stopped using opioids for at least 6 months went on to use them again. This high rate “suggests that physicians and patients need to be aware of the high risk of dependence and addiction for some individuals,” Dr. Ghani said. “Studying prescription fill behaviors and the persistence of prescription opioid users helps identify individuals at high risk for persistent use and may provide a better understanding of how to target interventions for inappropriate opioid use.”
The study has limitations. It does not indicate whether patients became substance abusers, nor does it provide details about opioids obtained illegally. Still, “we do know from literature and clinical experience that staying on prescription opioids may lead to dependence, escalation of dose, and increased risk of developing addictions that can lead to using street drugs like heroin,” Dr. Ghani said.
Magellan funded the study. Dr. Ghani reported no additional disclosures.
SAN DIEGO – A new study of medical records offers insights into the persistence of opioid use: Most patients who were prescribed opioid painkillers did not go back for a refill right away, but nearly half of patients who stopped taking the drugs for at least 6 months ended up using them again over a 3-year period.
“This key finding indicates that programs that address opioid use need to focus on long-term support and education to ensure that individuals do not become long-term users,” psychiatrist and lead author Shareh Ghani, MD, vice president and medical director of Magellan Health Services, San Francisco, said in an interview.
Researchers also found that opioid use appeared linked to three unexpected conditions – lipid disorders, hypertension, and sleep-wake disorders – and found that more than half of those who had at least two prescriptions for high-dose opioids kept taking the drugs over 18 months after an initial 90-day period.
Dr. Ghani and his colleague, Gowri Shetty, MPH, analyzed medical and pharmacy data from 2009-2012 for 2.5 million people. The participants, aged 20-64 years, came from across the United States and were part of a commercial health plan.
The researchers found that 21% had received one prescription for an opioid. Users considered at risk for persistent use – more than one prescription over 3 years – were more likely than were nonusers to have these characteristics: spondylosis and other back problems (odds ratio, 5.3), substance-related and addictive disorders (OR, 4.6), sleep-wake disorders (OR, 2.2), depressive disorders (OR, 1.7), headaches (OR, 2.1), and anxiety disorders (OR, 1.5.) The P values for all of those characteristics were less than .001.
They also found that patients who received certain kinds of treatment were at higher risk, compared with nonusers: those who were treated for substance abuse treatment (OR, 4.5), in emergency departments (OR, 3.2), with anesthesia (OR, 4.2), for mental health issues (OR, 2.3), and with surgery (OR, 2.0). The P values for all of those characteristics also were less than .001.
“The unexpected findings were the presence of lipid disorders, hypertension, and sleep-wake disorders. These diagnoses were not found in other literature,” Dr. Ghani said in an interview. “These conditions, however, are related to others that are known. For instance, a person with knee joint pain who is overweight – a known risk factor – may also have hypertension and lipid disorders.”
The researchers also discovered that 80% of patients who received an opioid prescription did not get a refill. Of those who had at least two prescriptions and a stable dose over an initial 90 days, 14% went on to have more prescriptions and a boost in dosage over 18 months, while 12% stayed the same and almost 74% took less.
But the situation was different for those with at least two prescriptions and a high dose (more than 120 mg) over an initial 90 days: 56% of them stayed at that level over 18 months.
The researchers also found that 48% of those who had stopped using opioids for at least 6 months went on to use them again. This high rate “suggests that physicians and patients need to be aware of the high risk of dependence and addiction for some individuals,” Dr. Ghani said. “Studying prescription fill behaviors and the persistence of prescription opioid users helps identify individuals at high risk for persistent use and may provide a better understanding of how to target interventions for inappropriate opioid use.”
The study has limitations. It does not indicate whether patients became substance abusers, nor does it provide details about opioids obtained illegally. Still, “we do know from literature and clinical experience that staying on prescription opioids may lead to dependence, escalation of dose, and increased risk of developing addictions that can lead to using street drugs like heroin,” Dr. Ghani said.
Magellan funded the study. Dr. Ghani reported no additional disclosures.
AT APA
Key clinical point:
Major finding: Forty-eight percent of patients who had stopped using opioids for at least 6 months went on to use them again.
Data source: An analysis of medical and pharmacy data from 2009-2012 for 2.5 million people aged 20-64 who were part of a commercial health plan.
Disclosures: Dr. Ghani is vice president and medical director of Magellan Health Services, which funded the study.
Involuntary commitment sought in 5% of anorexia admissions
SAN DIEGO – Court orders were sought to force 5% of patients admitted for anorexia nervosa disorders to remain involuntarily under hospital care, according to findings from a 4-year study of patients treated at a Colorado clinic.
Nearly all of the patients declined to fight those efforts. However, the orders were withdrawn in about one-quarter of cases because treatment was deemed to be futile.
The study findings point to the importance of seeking civil commitment early in the course of illness in patients with anorexia nervosa when it can do the most good, study author Patricia Westmoreland, MD, attending psychiatrist at the Eating Recovery Center in Denver, said in an interview.
Dr. Westmoreland presented the findings at the annual meeting of the American Psychiatric Association, where she contended that anorexia nervosa has the highest mortality of any psychiatric disorder. “If patients are not treated earlier in the course of their illness and when they’re at a younger age,” she said, “they develop severe and enduring eating disorders.”
Anorexia nervosa is estimated to have a prevalence rate of 0.3% in young women. Research suggests that 20% of people with the disease kill themselves (Int J Eat Disord. 2003 Dec;34[4]:383-96), (Arch Gen Psychiatry. 2011;68[7]:724-31).
For the new study, Dr. Westmoreland and her colleagues tracked 2,106 admissions of patients who were treated for two conditions – anorexia nervosa restricting subtype and anorexia nervosa binge purge subtype – at the Eating Recovery Center from April 2012 to March 2016. The ages and genders of the subjects were not available.
Officials sought involuntary care in 109, or 5.2%, of the admissions, including 11 patients who were recommitted at least once.
Of the 109 admissions:
• 85% waived the right to a hearing (94% of those who fought commitment ultimately were committed involuntarily).
• 31% successfully completed treatment.
• 24% had their commitments – also known as certifications – terminated because treatment appeared to be futile.
“These are patients for whom certification is only helpful to a point, beyond which it becomes harmful, i.e., patients harming themselves to leave a locked facility, patients pulling out NG tubes so many times they cause injury, patients who purge continuously despite being tube fed,” Dr. Westmoreland said in an interview. “In other cases, the team evaluated the patient and determined he or she is, in general, being harmed more than helped by trying to attain goal weight. This is where harm reduction may prove useful. And failing that, palliative or hospice care for a patient who has had many treatments over the years and has never recovered for any meaningful period of time.”
Dr. Westmoreland defined harm reduction in this context as “having patient being managed at an agreed-upon weight that is lower than an ideal body weight, but nonetheless a weight at which they can function and have some quality of life, even if that quality of life is not optimal.”
This also means that the patient must regularly check with an outpatient treatment team – dietitian, psychiatrist, and therapist – and be monitored for signs of unacceptable levels of weight loss or abnormal lab results, she said. These problems, she added, will trigger hospitalization.
Dr. Westmoreland reported no relevant disclosures.
SAN DIEGO – Court orders were sought to force 5% of patients admitted for anorexia nervosa disorders to remain involuntarily under hospital care, according to findings from a 4-year study of patients treated at a Colorado clinic.
Nearly all of the patients declined to fight those efforts. However, the orders were withdrawn in about one-quarter of cases because treatment was deemed to be futile.
The study findings point to the importance of seeking civil commitment early in the course of illness in patients with anorexia nervosa when it can do the most good, study author Patricia Westmoreland, MD, attending psychiatrist at the Eating Recovery Center in Denver, said in an interview.
Dr. Westmoreland presented the findings at the annual meeting of the American Psychiatric Association, where she contended that anorexia nervosa has the highest mortality of any psychiatric disorder. “If patients are not treated earlier in the course of their illness and when they’re at a younger age,” she said, “they develop severe and enduring eating disorders.”
Anorexia nervosa is estimated to have a prevalence rate of 0.3% in young women. Research suggests that 20% of people with the disease kill themselves (Int J Eat Disord. 2003 Dec;34[4]:383-96), (Arch Gen Psychiatry. 2011;68[7]:724-31).
For the new study, Dr. Westmoreland and her colleagues tracked 2,106 admissions of patients who were treated for two conditions – anorexia nervosa restricting subtype and anorexia nervosa binge purge subtype – at the Eating Recovery Center from April 2012 to March 2016. The ages and genders of the subjects were not available.
Officials sought involuntary care in 109, or 5.2%, of the admissions, including 11 patients who were recommitted at least once.
Of the 109 admissions:
• 85% waived the right to a hearing (94% of those who fought commitment ultimately were committed involuntarily).
• 31% successfully completed treatment.
• 24% had their commitments – also known as certifications – terminated because treatment appeared to be futile.
“These are patients for whom certification is only helpful to a point, beyond which it becomes harmful, i.e., patients harming themselves to leave a locked facility, patients pulling out NG tubes so many times they cause injury, patients who purge continuously despite being tube fed,” Dr. Westmoreland said in an interview. “In other cases, the team evaluated the patient and determined he or she is, in general, being harmed more than helped by trying to attain goal weight. This is where harm reduction may prove useful. And failing that, palliative or hospice care for a patient who has had many treatments over the years and has never recovered for any meaningful period of time.”
Dr. Westmoreland defined harm reduction in this context as “having patient being managed at an agreed-upon weight that is lower than an ideal body weight, but nonetheless a weight at which they can function and have some quality of life, even if that quality of life is not optimal.”
This also means that the patient must regularly check with an outpatient treatment team – dietitian, psychiatrist, and therapist – and be monitored for signs of unacceptable levels of weight loss or abnormal lab results, she said. These problems, she added, will trigger hospitalization.
Dr. Westmoreland reported no relevant disclosures.
SAN DIEGO – Court orders were sought to force 5% of patients admitted for anorexia nervosa disorders to remain involuntarily under hospital care, according to findings from a 4-year study of patients treated at a Colorado clinic.
Nearly all of the patients declined to fight those efforts. However, the orders were withdrawn in about one-quarter of cases because treatment was deemed to be futile.
The study findings point to the importance of seeking civil commitment early in the course of illness in patients with anorexia nervosa when it can do the most good, study author Patricia Westmoreland, MD, attending psychiatrist at the Eating Recovery Center in Denver, said in an interview.
Dr. Westmoreland presented the findings at the annual meeting of the American Psychiatric Association, where she contended that anorexia nervosa has the highest mortality of any psychiatric disorder. “If patients are not treated earlier in the course of their illness and when they’re at a younger age,” she said, “they develop severe and enduring eating disorders.”
Anorexia nervosa is estimated to have a prevalence rate of 0.3% in young women. Research suggests that 20% of people with the disease kill themselves (Int J Eat Disord. 2003 Dec;34[4]:383-96), (Arch Gen Psychiatry. 2011;68[7]:724-31).
For the new study, Dr. Westmoreland and her colleagues tracked 2,106 admissions of patients who were treated for two conditions – anorexia nervosa restricting subtype and anorexia nervosa binge purge subtype – at the Eating Recovery Center from April 2012 to March 2016. The ages and genders of the subjects were not available.
Officials sought involuntary care in 109, or 5.2%, of the admissions, including 11 patients who were recommitted at least once.
Of the 109 admissions:
• 85% waived the right to a hearing (94% of those who fought commitment ultimately were committed involuntarily).
• 31% successfully completed treatment.
• 24% had their commitments – also known as certifications – terminated because treatment appeared to be futile.
“These are patients for whom certification is only helpful to a point, beyond which it becomes harmful, i.e., patients harming themselves to leave a locked facility, patients pulling out NG tubes so many times they cause injury, patients who purge continuously despite being tube fed,” Dr. Westmoreland said in an interview. “In other cases, the team evaluated the patient and determined he or she is, in general, being harmed more than helped by trying to attain goal weight. This is where harm reduction may prove useful. And failing that, palliative or hospice care for a patient who has had many treatments over the years and has never recovered for any meaningful period of time.”
Dr. Westmoreland defined harm reduction in this context as “having patient being managed at an agreed-upon weight that is lower than an ideal body weight, but nonetheless a weight at which they can function and have some quality of life, even if that quality of life is not optimal.”
This also means that the patient must regularly check with an outpatient treatment team – dietitian, psychiatrist, and therapist – and be monitored for signs of unacceptable levels of weight loss or abnormal lab results, she said. These problems, she added, will trigger hospitalization.
Dr. Westmoreland reported no relevant disclosures.
AT APA
Higher ADHD risk seen in children with migraine
BOSTON – Children aged 5-12 years with signs of migraine headache were as much as seven times as likely as other children to also appear to have attention-deficit/hyperactivity disorder (ADHD), but those with tension-type headaches didn’t face a higher risk of ADHD, a Brazilian study showed.
It’s not clear why the apparent link between migraines and ADHD exists. However, lead study author Marco Antônio Arruda, MD, PhD, a pediatric neurologist in São Paulo (Brazil) University, said in an interview that other research has linked migraine to mental health problems.
The study, presented at the annual meeting of the American Academy of Neurology and published online in the Journal of Attention Disorders (2017. doi: 10.1177/1087054717710767), was launched to better understand the connection between migraine and ADHD, which are thought to each affect as many as 1 in 10 children.
The study analyzes data from mothers and teachers of 5,671 children aged 5-12 years who answered questions as part of a Brazil-wide epidemiologic study called the Attention Brazil Project. Just over half of the participants were boys, and about half were from the Brazilian middle class.
Based on answers from mothers and teachers, the researchers estimated that 9% of the children had episodic migraine and 0.6% had chronic migraine. The level of episodic tension-type headache was estimated at 12.8%, with a lower rate in the two poorest vs. the two richest quintiles (8.6% vs. 14.4%, respectively; relative risk, 0.6; 95% confidence interval, 0.5-0.8).
The researchers estimated that 5.3% of the children overall showed signs of ADHD (7.5% in boys vs. 3.1% in girls; RR, 2.4; 95% CI, 1.9-3.1).
There was no sign that children with tension-type headaches had a significantly higher risk of ADHD than other children. However, compared with controls, those with various types of migraine headaches did have a higher risk of ADHD. Nearly 11% of those with migraine overall showed signs of ADHD, compared with 2.6% of the control group (RR, 4.1; 95% CI, 2.7-6.2). The numbers for episodic migraine were nearly identical to those for migraine overall: 10.2% vs. 2.6% (RR, 3.8; 95% CI, 2.5-5.9).
Just over 19% of kids in a third migraine group – those with chronic migraine, defined as headaches appearing more than 14 days per month for the last 3 months – showed signs of ADHD, compared with just 2.6% of the control group (RR = 7.3; 95% CI, 3.5-15.5).
“A number of risk factors to the association were identified, including male gender, prenatal exposure to tobacco, high headache frequency, and below average school performance,” Dr. Arruda said. “However, we did not find a significant influence of age, race, city density, national region where a child lives, income class, and prenatal exposure to alcohol in the comorbidity of ADHD and migraine in this sample. These results help us to identify risk groups allowing early interventions.”
Regarding an explanation for the links between migraines and ADHD, Dr. Arruda pointed to genetic and epigenetic factors that affect brain neurotransmitters and said he believes that stress and other stimuli could be influencing dopamine and noradrenergic processes.
Dr. Arruda said his next step is to examine whether stimulant drugs – the class used to treat ADHD – may help reduce headaches too.
“My clinical experience strongly indicates that psychostimulants have a highly positive effect on migraine prophylaxis, although headache occurs in the very beginning of the treatment,” Dr. Arruda said. “So, we are looking for financial support to conduct a randomized, double-blind, placebo control study to check this hypothesis.”
The study received no specific funding, and Dr. Arruda reported no relevant financial disclosures.
BOSTON – Children aged 5-12 years with signs of migraine headache were as much as seven times as likely as other children to also appear to have attention-deficit/hyperactivity disorder (ADHD), but those with tension-type headaches didn’t face a higher risk of ADHD, a Brazilian study showed.
It’s not clear why the apparent link between migraines and ADHD exists. However, lead study author Marco Antônio Arruda, MD, PhD, a pediatric neurologist in São Paulo (Brazil) University, said in an interview that other research has linked migraine to mental health problems.
The study, presented at the annual meeting of the American Academy of Neurology and published online in the Journal of Attention Disorders (2017. doi: 10.1177/1087054717710767), was launched to better understand the connection between migraine and ADHD, which are thought to each affect as many as 1 in 10 children.
The study analyzes data from mothers and teachers of 5,671 children aged 5-12 years who answered questions as part of a Brazil-wide epidemiologic study called the Attention Brazil Project. Just over half of the participants were boys, and about half were from the Brazilian middle class.
Based on answers from mothers and teachers, the researchers estimated that 9% of the children had episodic migraine and 0.6% had chronic migraine. The level of episodic tension-type headache was estimated at 12.8%, with a lower rate in the two poorest vs. the two richest quintiles (8.6% vs. 14.4%, respectively; relative risk, 0.6; 95% confidence interval, 0.5-0.8).
The researchers estimated that 5.3% of the children overall showed signs of ADHD (7.5% in boys vs. 3.1% in girls; RR, 2.4; 95% CI, 1.9-3.1).
There was no sign that children with tension-type headaches had a significantly higher risk of ADHD than other children. However, compared with controls, those with various types of migraine headaches did have a higher risk of ADHD. Nearly 11% of those with migraine overall showed signs of ADHD, compared with 2.6% of the control group (RR, 4.1; 95% CI, 2.7-6.2). The numbers for episodic migraine were nearly identical to those for migraine overall: 10.2% vs. 2.6% (RR, 3.8; 95% CI, 2.5-5.9).
Just over 19% of kids in a third migraine group – those with chronic migraine, defined as headaches appearing more than 14 days per month for the last 3 months – showed signs of ADHD, compared with just 2.6% of the control group (RR = 7.3; 95% CI, 3.5-15.5).
“A number of risk factors to the association were identified, including male gender, prenatal exposure to tobacco, high headache frequency, and below average school performance,” Dr. Arruda said. “However, we did not find a significant influence of age, race, city density, national region where a child lives, income class, and prenatal exposure to alcohol in the comorbidity of ADHD and migraine in this sample. These results help us to identify risk groups allowing early interventions.”
Regarding an explanation for the links between migraines and ADHD, Dr. Arruda pointed to genetic and epigenetic factors that affect brain neurotransmitters and said he believes that stress and other stimuli could be influencing dopamine and noradrenergic processes.
Dr. Arruda said his next step is to examine whether stimulant drugs – the class used to treat ADHD – may help reduce headaches too.
“My clinical experience strongly indicates that psychostimulants have a highly positive effect on migraine prophylaxis, although headache occurs in the very beginning of the treatment,” Dr. Arruda said. “So, we are looking for financial support to conduct a randomized, double-blind, placebo control study to check this hypothesis.”
The study received no specific funding, and Dr. Arruda reported no relevant financial disclosures.
BOSTON – Children aged 5-12 years with signs of migraine headache were as much as seven times as likely as other children to also appear to have attention-deficit/hyperactivity disorder (ADHD), but those with tension-type headaches didn’t face a higher risk of ADHD, a Brazilian study showed.
It’s not clear why the apparent link between migraines and ADHD exists. However, lead study author Marco Antônio Arruda, MD, PhD, a pediatric neurologist in São Paulo (Brazil) University, said in an interview that other research has linked migraine to mental health problems.
The study, presented at the annual meeting of the American Academy of Neurology and published online in the Journal of Attention Disorders (2017. doi: 10.1177/1087054717710767), was launched to better understand the connection between migraine and ADHD, which are thought to each affect as many as 1 in 10 children.
The study analyzes data from mothers and teachers of 5,671 children aged 5-12 years who answered questions as part of a Brazil-wide epidemiologic study called the Attention Brazil Project. Just over half of the participants were boys, and about half were from the Brazilian middle class.
Based on answers from mothers and teachers, the researchers estimated that 9% of the children had episodic migraine and 0.6% had chronic migraine. The level of episodic tension-type headache was estimated at 12.8%, with a lower rate in the two poorest vs. the two richest quintiles (8.6% vs. 14.4%, respectively; relative risk, 0.6; 95% confidence interval, 0.5-0.8).
The researchers estimated that 5.3% of the children overall showed signs of ADHD (7.5% in boys vs. 3.1% in girls; RR, 2.4; 95% CI, 1.9-3.1).
There was no sign that children with tension-type headaches had a significantly higher risk of ADHD than other children. However, compared with controls, those with various types of migraine headaches did have a higher risk of ADHD. Nearly 11% of those with migraine overall showed signs of ADHD, compared with 2.6% of the control group (RR, 4.1; 95% CI, 2.7-6.2). The numbers for episodic migraine were nearly identical to those for migraine overall: 10.2% vs. 2.6% (RR, 3.8; 95% CI, 2.5-5.9).
Just over 19% of kids in a third migraine group – those with chronic migraine, defined as headaches appearing more than 14 days per month for the last 3 months – showed signs of ADHD, compared with just 2.6% of the control group (RR = 7.3; 95% CI, 3.5-15.5).
“A number of risk factors to the association were identified, including male gender, prenatal exposure to tobacco, high headache frequency, and below average school performance,” Dr. Arruda said. “However, we did not find a significant influence of age, race, city density, national region where a child lives, income class, and prenatal exposure to alcohol in the comorbidity of ADHD and migraine in this sample. These results help us to identify risk groups allowing early interventions.”
Regarding an explanation for the links between migraines and ADHD, Dr. Arruda pointed to genetic and epigenetic factors that affect brain neurotransmitters and said he believes that stress and other stimuli could be influencing dopamine and noradrenergic processes.
Dr. Arruda said his next step is to examine whether stimulant drugs – the class used to treat ADHD – may help reduce headaches too.
“My clinical experience strongly indicates that psychostimulants have a highly positive effect on migraine prophylaxis, although headache occurs in the very beginning of the treatment,” Dr. Arruda said. “So, we are looking for financial support to conduct a randomized, double-blind, placebo control study to check this hypothesis.”
The study received no specific funding, and Dr. Arruda reported no relevant financial disclosures.
AT AAN 2017
Key clinical point: , but there’s no excess risk in children with tension-type headaches.
Major finding: Of children with chronic migraine, 19.4% (0.6% of the total) showed signs of ADHD, vs. 2.6% of the control group (RR, 7.3; 95% CI, 3.5-15.5).
Data source: Surveys of mothers and teachers of 5,671 Brazilian children aged 5-12 years.
Disclosures: The study received no specific funding, and Dr. Arruda reported no relevant financial disclosures.
As designer drugs multiply, toxicologists spring into action
SAN DIEGO – Forensic toxicologist Donna Papsun spends her days with drugs, but she doesn’t see patients or try to make anyone better. Still, her work is crucial to every medical professional who needs to know which new illicit drugs their patients have been taking.
In Willow Grove, Pa., a suburb of Philadelphia, Ms. Papsun and her colleagues at NMS Labs develop screening tests for designer drugs that have just appeared on the black market or crossed the Drug Enforcement Administration’s (DEA) radar.
As Ms. Papsun told an audience at the annual meeting of the American Psychiatric Association, she faced a unique obstacle last summer, when an elephant tranquilizer called carfentanil, a derivative of fentanyl, began to make headlines. The obstacle? The U.S.-Canada border.
She wanted to develop a test for the opioid but couldn’t start until she got a reference sample of the controlled substance from carfentanil’s only manufacturer, a firm in Canada. It took months. “Crossing an international border caused all sorts of problems,” she said.
New designer drugs are constantly hitting the market. They’re often especially appealing – and especially risky – because routine drug tests can’t detect them, at least not yet.
In an interview, Ms. Papsun talked about the challenges of trying to keep up with the drug makers – and users.
“Designer drug testing developed back in 2008 will not catch anything that is seen in today’s designer drug market,” she said. “Designer drug testing requires constant attention, assessment, resources, and updating.”
Question: How long does it typically take to create a test for a new strain of illicit drug?
Answer: This can take anywhere from 3 to 9 months, and potentially longer, and it depends on many factors. Once a new drug has hit the market, we check to see if there is certified reference material available. If there is, then we can start to develop a test. Development includes identifying a successful chemical extraction technique – isolating the drug in question from biological matrix such as blood or urine – as well as a platform that reliably detects the drug without falsely reporting positives.
After development, the test has to go through a process called validation, which is a series of experiments to prove that the developed method works rigorously, day after day, and provides the same results. This is very important in forensic toxicology, because our results may be involved in criminal and civil litigation and must stand up to the rigors of court.
Q: What are some examples of the types of drugs that you’ve had to develop tests for?
A: Just in the past year, we have developed tests for new designer opioids (including carfentanil, furanylfentanyl, acrylfentanyl, and U-47700), designer benzodiazepines (including etizolam, diclazepam, flubromazolam, and flubromazepam) and new designer stimulants (including n-ethyl pentylone and dibutylone).
We have a synthetic cannabinoid test that was developed for the first time back in 2010. That test has been redeveloped several times since then, because we constantly have to update the test to keep up with the rapid changes in market availability of substances.
Q: What are some of the challenges that you face in terms of getting samples of human fluids that you can test for the drugs?
A: Most of the samples we see are from either death investigation cases or driving-under-the-influence cases. Samples from intoxications at hospitals are important, because those data help [us] understand the concentrations of drugs at which people can survive. But often, if the patients survive, their biological specimens are not forwarded for specialized toxicology testing. Most hospital systems do not have the analytical capabilities to detect designer drugs, and most lack the resources to seek out the causal agent for an intoxication or apparent overdose.
Q: At the APA meeting, you talked about the risk that you’ll hear about a strain from the DEA, develop a test and find out it’s obsolete because the drug isn’t used anymore. Does that happen very often?
A: Yes. The problem with designer drugs is that there are so many, so you can spend a lot of time, money, and other resources dedicated to developing and validating a test for a drug that may or may not even be popular.
As a business, you have to make decisions regarding prioritization: Do we build a test for a drug that has only been reported once, or do we focus our efforts on a substance that has been reported dozens of times?
We certainly have spent time and resources developing a test that became obsolete, or never reported a positive case. For example, we developed a test for desomorphine, and we have never chemically confirmed desomorphine in a biological specimen. It definitely is hit or miss, but we spend a lot of time and research a lot of different avenues to make educated decisions regarding the substances we develop tests for.
SAN DIEGO – Forensic toxicologist Donna Papsun spends her days with drugs, but she doesn’t see patients or try to make anyone better. Still, her work is crucial to every medical professional who needs to know which new illicit drugs their patients have been taking.
In Willow Grove, Pa., a suburb of Philadelphia, Ms. Papsun and her colleagues at NMS Labs develop screening tests for designer drugs that have just appeared on the black market or crossed the Drug Enforcement Administration’s (DEA) radar.
As Ms. Papsun told an audience at the annual meeting of the American Psychiatric Association, she faced a unique obstacle last summer, when an elephant tranquilizer called carfentanil, a derivative of fentanyl, began to make headlines. The obstacle? The U.S.-Canada border.
She wanted to develop a test for the opioid but couldn’t start until she got a reference sample of the controlled substance from carfentanil’s only manufacturer, a firm in Canada. It took months. “Crossing an international border caused all sorts of problems,” she said.
New designer drugs are constantly hitting the market. They’re often especially appealing – and especially risky – because routine drug tests can’t detect them, at least not yet.
In an interview, Ms. Papsun talked about the challenges of trying to keep up with the drug makers – and users.
“Designer drug testing developed back in 2008 will not catch anything that is seen in today’s designer drug market,” she said. “Designer drug testing requires constant attention, assessment, resources, and updating.”
Question: How long does it typically take to create a test for a new strain of illicit drug?
Answer: This can take anywhere from 3 to 9 months, and potentially longer, and it depends on many factors. Once a new drug has hit the market, we check to see if there is certified reference material available. If there is, then we can start to develop a test. Development includes identifying a successful chemical extraction technique – isolating the drug in question from biological matrix such as blood or urine – as well as a platform that reliably detects the drug without falsely reporting positives.
After development, the test has to go through a process called validation, which is a series of experiments to prove that the developed method works rigorously, day after day, and provides the same results. This is very important in forensic toxicology, because our results may be involved in criminal and civil litigation and must stand up to the rigors of court.
Q: What are some examples of the types of drugs that you’ve had to develop tests for?
A: Just in the past year, we have developed tests for new designer opioids (including carfentanil, furanylfentanyl, acrylfentanyl, and U-47700), designer benzodiazepines (including etizolam, diclazepam, flubromazolam, and flubromazepam) and new designer stimulants (including n-ethyl pentylone and dibutylone).
We have a synthetic cannabinoid test that was developed for the first time back in 2010. That test has been redeveloped several times since then, because we constantly have to update the test to keep up with the rapid changes in market availability of substances.
Q: What are some of the challenges that you face in terms of getting samples of human fluids that you can test for the drugs?
A: Most of the samples we see are from either death investigation cases or driving-under-the-influence cases. Samples from intoxications at hospitals are important, because those data help [us] understand the concentrations of drugs at which people can survive. But often, if the patients survive, their biological specimens are not forwarded for specialized toxicology testing. Most hospital systems do not have the analytical capabilities to detect designer drugs, and most lack the resources to seek out the causal agent for an intoxication or apparent overdose.
Q: At the APA meeting, you talked about the risk that you’ll hear about a strain from the DEA, develop a test and find out it’s obsolete because the drug isn’t used anymore. Does that happen very often?
A: Yes. The problem with designer drugs is that there are so many, so you can spend a lot of time, money, and other resources dedicated to developing and validating a test for a drug that may or may not even be popular.
As a business, you have to make decisions regarding prioritization: Do we build a test for a drug that has only been reported once, or do we focus our efforts on a substance that has been reported dozens of times?
We certainly have spent time and resources developing a test that became obsolete, or never reported a positive case. For example, we developed a test for desomorphine, and we have never chemically confirmed desomorphine in a biological specimen. It definitely is hit or miss, but we spend a lot of time and research a lot of different avenues to make educated decisions regarding the substances we develop tests for.
SAN DIEGO – Forensic toxicologist Donna Papsun spends her days with drugs, but she doesn’t see patients or try to make anyone better. Still, her work is crucial to every medical professional who needs to know which new illicit drugs their patients have been taking.
In Willow Grove, Pa., a suburb of Philadelphia, Ms. Papsun and her colleagues at NMS Labs develop screening tests for designer drugs that have just appeared on the black market or crossed the Drug Enforcement Administration’s (DEA) radar.
As Ms. Papsun told an audience at the annual meeting of the American Psychiatric Association, she faced a unique obstacle last summer, when an elephant tranquilizer called carfentanil, a derivative of fentanyl, began to make headlines. The obstacle? The U.S.-Canada border.
She wanted to develop a test for the opioid but couldn’t start until she got a reference sample of the controlled substance from carfentanil’s only manufacturer, a firm in Canada. It took months. “Crossing an international border caused all sorts of problems,” she said.
New designer drugs are constantly hitting the market. They’re often especially appealing – and especially risky – because routine drug tests can’t detect them, at least not yet.
In an interview, Ms. Papsun talked about the challenges of trying to keep up with the drug makers – and users.
“Designer drug testing developed back in 2008 will not catch anything that is seen in today’s designer drug market,” she said. “Designer drug testing requires constant attention, assessment, resources, and updating.”
Question: How long does it typically take to create a test for a new strain of illicit drug?
Answer: This can take anywhere from 3 to 9 months, and potentially longer, and it depends on many factors. Once a new drug has hit the market, we check to see if there is certified reference material available. If there is, then we can start to develop a test. Development includes identifying a successful chemical extraction technique – isolating the drug in question from biological matrix such as blood or urine – as well as a platform that reliably detects the drug without falsely reporting positives.
After development, the test has to go through a process called validation, which is a series of experiments to prove that the developed method works rigorously, day after day, and provides the same results. This is very important in forensic toxicology, because our results may be involved in criminal and civil litigation and must stand up to the rigors of court.
Q: What are some examples of the types of drugs that you’ve had to develop tests for?
A: Just in the past year, we have developed tests for new designer opioids (including carfentanil, furanylfentanyl, acrylfentanyl, and U-47700), designer benzodiazepines (including etizolam, diclazepam, flubromazolam, and flubromazepam) and new designer stimulants (including n-ethyl pentylone and dibutylone).
We have a synthetic cannabinoid test that was developed for the first time back in 2010. That test has been redeveloped several times since then, because we constantly have to update the test to keep up with the rapid changes in market availability of substances.
Q: What are some of the challenges that you face in terms of getting samples of human fluids that you can test for the drugs?
A: Most of the samples we see are from either death investigation cases or driving-under-the-influence cases. Samples from intoxications at hospitals are important, because those data help [us] understand the concentrations of drugs at which people can survive. But often, if the patients survive, their biological specimens are not forwarded for specialized toxicology testing. Most hospital systems do not have the analytical capabilities to detect designer drugs, and most lack the resources to seek out the causal agent for an intoxication or apparent overdose.
Q: At the APA meeting, you talked about the risk that you’ll hear about a strain from the DEA, develop a test and find out it’s obsolete because the drug isn’t used anymore. Does that happen very often?
A: Yes. The problem with designer drugs is that there are so many, so you can spend a lot of time, money, and other resources dedicated to developing and validating a test for a drug that may or may not even be popular.
As a business, you have to make decisions regarding prioritization: Do we build a test for a drug that has only been reported once, or do we focus our efforts on a substance that has been reported dozens of times?
We certainly have spent time and resources developing a test that became obsolete, or never reported a positive case. For example, we developed a test for desomorphine, and we have never chemically confirmed desomorphine in a biological specimen. It definitely is hit or miss, but we spend a lot of time and research a lot of different avenues to make educated decisions regarding the substances we develop tests for.
EXPERT ANALYSIS FROM APA
Gene therapy for spinal muscular atrophy shows promise in early study
BOSTON – Promising results were evident in an ongoing phase I study of a gene therapy for spinal muscular atrophy type 1 (SMA1), with children in the trial walking, talking, and moving.
After a single intravenous infusion of the therapy, AVXS-101, children in the industry-funded study achieved unexpected progress in terms of physical achievement ad survival, researchers reported at the annual meeting of the American Academy of Neurology.
Video clips showed children in the trial rolling, sitting unassisted, and showing normal levels of hand and fine motor control. No other children with SMA1 have been reported to reach any major motor milestone.
In one clip, an 18-month-old boy toddles down a hallway and carries an electronic toy to an elevator where he reaches up to press the button. “He’s basically completely back to normal. You see and examine him; it just about takes your breath away,” said the study’s lead investigator, Jerry R. Mendell, MD, a neurologist at Nationwide Children’s Hospital, Columbus, Ohio.
All 15 patients in the study were alive as of the AAN presentation, with six older than aged 2 years. Previous studies have reported various life expectancies for SMA1 patients: A 2010 Korean study of 14 SMA1 patients reported that the average lifespan was 22.8 ± 2.0 months (Korean J Pediatr. 2010 Nov;53[11]:965-70), while a 2007 Hong Kong study (n = 22) found that only 30% survived to aged 4 years and all survivors were venilator-dependent (Pediatrics. 2004 Nov;114[5]:e548-53).
The open label phase I dose-escalating study recruited 15 patients (nine under aged 9 months; six 6 under aged 6 months) with SMA1 as defined by genetic criteria and onset between birth and 6 months. All received a one-time intravenous infusion of AVXS-101 after a 1-mg/1-kg dose of prednisolone the previous day. AVXS-101 is designed to boost levels of the SMN protein via delivery of a functional human SMN gene into motor neuron cells.
The first cohort of three patients received one dose. All survived to greater than aged 30 months, although one did require respiratory assistance at about 30 months, said Dr. Mendell, professor of pediatrics, neurology, pathology, and physiology and cell Biology at Ohio State University, Columbus.
Researchers moved to a larger dose, “the highest amount of virus that’s ever been given in any clinical trial,” Dr. Mendell said. The first patient has passed 30 months of age, and 9 patients have reached at least 20 months, he noted.
In this second cohort, all patients “are able to bring hand to mouth, which is obviously important for feeding. Eleven of the 12 have good head control, and 9 of the patients can roll over. And 11 can sit without assistance,” he said.
In addition, eight can sit more than 30 seconds, and two can crawl, stand, and walk independently. Eight of 12 patients are speaking, and 11 of 12 are feeding orally.
To date, five treatment-related adverse events in four patients have been reported – all asymptomatic increases in liver function enzymes, which resolved.
The study is funded by AveXis, the company developing this gene therapy. Dr. Mendell reported compensation for consulting and research support from AveXis and Sarepta Therapeutics.
BOSTON – Promising results were evident in an ongoing phase I study of a gene therapy for spinal muscular atrophy type 1 (SMA1), with children in the trial walking, talking, and moving.
After a single intravenous infusion of the therapy, AVXS-101, children in the industry-funded study achieved unexpected progress in terms of physical achievement ad survival, researchers reported at the annual meeting of the American Academy of Neurology.
Video clips showed children in the trial rolling, sitting unassisted, and showing normal levels of hand and fine motor control. No other children with SMA1 have been reported to reach any major motor milestone.
In one clip, an 18-month-old boy toddles down a hallway and carries an electronic toy to an elevator where he reaches up to press the button. “He’s basically completely back to normal. You see and examine him; it just about takes your breath away,” said the study’s lead investigator, Jerry R. Mendell, MD, a neurologist at Nationwide Children’s Hospital, Columbus, Ohio.
All 15 patients in the study were alive as of the AAN presentation, with six older than aged 2 years. Previous studies have reported various life expectancies for SMA1 patients: A 2010 Korean study of 14 SMA1 patients reported that the average lifespan was 22.8 ± 2.0 months (Korean J Pediatr. 2010 Nov;53[11]:965-70), while a 2007 Hong Kong study (n = 22) found that only 30% survived to aged 4 years and all survivors were venilator-dependent (Pediatrics. 2004 Nov;114[5]:e548-53).
The open label phase I dose-escalating study recruited 15 patients (nine under aged 9 months; six 6 under aged 6 months) with SMA1 as defined by genetic criteria and onset between birth and 6 months. All received a one-time intravenous infusion of AVXS-101 after a 1-mg/1-kg dose of prednisolone the previous day. AVXS-101 is designed to boost levels of the SMN protein via delivery of a functional human SMN gene into motor neuron cells.
The first cohort of three patients received one dose. All survived to greater than aged 30 months, although one did require respiratory assistance at about 30 months, said Dr. Mendell, professor of pediatrics, neurology, pathology, and physiology and cell Biology at Ohio State University, Columbus.
Researchers moved to a larger dose, “the highest amount of virus that’s ever been given in any clinical trial,” Dr. Mendell said. The first patient has passed 30 months of age, and 9 patients have reached at least 20 months, he noted.
In this second cohort, all patients “are able to bring hand to mouth, which is obviously important for feeding. Eleven of the 12 have good head control, and 9 of the patients can roll over. And 11 can sit without assistance,” he said.
In addition, eight can sit more than 30 seconds, and two can crawl, stand, and walk independently. Eight of 12 patients are speaking, and 11 of 12 are feeding orally.
To date, five treatment-related adverse events in four patients have been reported – all asymptomatic increases in liver function enzymes, which resolved.
The study is funded by AveXis, the company developing this gene therapy. Dr. Mendell reported compensation for consulting and research support from AveXis and Sarepta Therapeutics.
BOSTON – Promising results were evident in an ongoing phase I study of a gene therapy for spinal muscular atrophy type 1 (SMA1), with children in the trial walking, talking, and moving.
After a single intravenous infusion of the therapy, AVXS-101, children in the industry-funded study achieved unexpected progress in terms of physical achievement ad survival, researchers reported at the annual meeting of the American Academy of Neurology.
Video clips showed children in the trial rolling, sitting unassisted, and showing normal levels of hand and fine motor control. No other children with SMA1 have been reported to reach any major motor milestone.
In one clip, an 18-month-old boy toddles down a hallway and carries an electronic toy to an elevator where he reaches up to press the button. “He’s basically completely back to normal. You see and examine him; it just about takes your breath away,” said the study’s lead investigator, Jerry R. Mendell, MD, a neurologist at Nationwide Children’s Hospital, Columbus, Ohio.
All 15 patients in the study were alive as of the AAN presentation, with six older than aged 2 years. Previous studies have reported various life expectancies for SMA1 patients: A 2010 Korean study of 14 SMA1 patients reported that the average lifespan was 22.8 ± 2.0 months (Korean J Pediatr. 2010 Nov;53[11]:965-70), while a 2007 Hong Kong study (n = 22) found that only 30% survived to aged 4 years and all survivors were venilator-dependent (Pediatrics. 2004 Nov;114[5]:e548-53).
The open label phase I dose-escalating study recruited 15 patients (nine under aged 9 months; six 6 under aged 6 months) with SMA1 as defined by genetic criteria and onset between birth and 6 months. All received a one-time intravenous infusion of AVXS-101 after a 1-mg/1-kg dose of prednisolone the previous day. AVXS-101 is designed to boost levels of the SMN protein via delivery of a functional human SMN gene into motor neuron cells.
The first cohort of three patients received one dose. All survived to greater than aged 30 months, although one did require respiratory assistance at about 30 months, said Dr. Mendell, professor of pediatrics, neurology, pathology, and physiology and cell Biology at Ohio State University, Columbus.
Researchers moved to a larger dose, “the highest amount of virus that’s ever been given in any clinical trial,” Dr. Mendell said. The first patient has passed 30 months of age, and 9 patients have reached at least 20 months, he noted.
In this second cohort, all patients “are able to bring hand to mouth, which is obviously important for feeding. Eleven of the 12 have good head control, and 9 of the patients can roll over. And 11 can sit without assistance,” he said.
In addition, eight can sit more than 30 seconds, and two can crawl, stand, and walk independently. Eight of 12 patients are speaking, and 11 of 12 are feeding orally.
To date, five treatment-related adverse events in four patients have been reported – all asymptomatic increases in liver function enzymes, which resolved.
The study is funded by AveXis, the company developing this gene therapy. Dr. Mendell reported compensation for consulting and research support from AveXis and Sarepta Therapeutics.
AT AAN 2017
Red flags for type 2 diabetes seen 25 years before diagnosis
SAN DIEGO – Based on their analysis of a cohort of more than half a million people, Swedish researchers now believe that mildly elevated fasting plasma glucose and triglyceride levels could indicate an increased risk for type 2 diabetes a quarter-century before diagnosis.
“Previous studies have shown that risk factors for type 2 diabetes, including obesity and elevated fasting glucose, may be present up to 10 years before disease onset. Our study extends this period to more than 20 years before diagnosis,” said the study’s lead author Håkan Malmström, PhD, an epidemiologist with the Karolinska Institute, Stockholm. “Even small elevations in subjects over time early in life may be important to recognize, in particular for people who are overweight or obese.” The study findings were presented in an oral presentation at the scientific sessions of the American Diabetes Association.
The researchers identified 47,997 new type 2 diabetes cases in a Swedish cohort of 537,119 people tracked from 1985-2012. For each case, they compared risk factors from clinical examinations performed from 1985-1996 with those of five matched controls.
They found that on average, several risk factors were more common among individuals with type 2 diabetes, compared with the matched controls “many years before the diagnosis,” Dr. Malmström said. “In particular, BMI [body mass index], fasting triglycerides, fasting glucose, the apo B/apo A-I ratio and inflammatory markers were increased up to 25 years before the diagnosis.”
For example, 25 years before diagnosis, mean fasting plasma glucose in the type 2 diabetes group was higher than controls at 90 mg/dL vs. 86 mg/dL, respectively. By 10 years before diagnosis, that gap had widened to 98 mg/dL vs. 88 mg/dL. At 1 year before diagnosis, the levels were 106 mg/dl vs. 90 mg/dL.
As for fasting triglycerides, high levels earlier in life appeared to be especially risky: Individuals with levels over 124 mg/dL were more likely to develop type 2 diabetes 20 years later, even if they weren’t overweight or had elevated mean fasting glucose levels.
At 25 years before diagnosis, the type 2 diabetes group had mean fasting triglyceride levels of 120 mg/dL vs. 89 mg/dL in the control group. And at 1 year before diagnosis, the difference had widened to 146 mg/dL vs. 106 mg/dL.
Researchers found signs of higher levels of fructosamine – a marker of glycemic levels over an extended period of time (2-3 weeks) – at about 15 years before diagnosis. According to Dr. Malmström, this finding suggests that “glucose metabolism was starting to become more disturbed later than the changes in fasting glucose, but still many years before the type 2 diabetes diagnosis.”
He speculated that early signs of type 2 diabetes revealed by the study are related to genetic predisposition. “The risk of developing the disease presents early with increased BMI and dyslipidemia, which in turn leads to successively decreased insulin sensitivity,” he said.
One step for future research, he added, would be to “elaborate on these early changes in risk factors and create a risk score based on a few easily available factors in clinical settings.”
The study was funded by Sweden’s Gunnar and Ingmar Jungner Foundation for Laboratory Medicine. Dr. Malmström reported no relevant disclosures.
SAN DIEGO – Based on their analysis of a cohort of more than half a million people, Swedish researchers now believe that mildly elevated fasting plasma glucose and triglyceride levels could indicate an increased risk for type 2 diabetes a quarter-century before diagnosis.
“Previous studies have shown that risk factors for type 2 diabetes, including obesity and elevated fasting glucose, may be present up to 10 years before disease onset. Our study extends this period to more than 20 years before diagnosis,” said the study’s lead author Håkan Malmström, PhD, an epidemiologist with the Karolinska Institute, Stockholm. “Even small elevations in subjects over time early in life may be important to recognize, in particular for people who are overweight or obese.” The study findings were presented in an oral presentation at the scientific sessions of the American Diabetes Association.
The researchers identified 47,997 new type 2 diabetes cases in a Swedish cohort of 537,119 people tracked from 1985-2012. For each case, they compared risk factors from clinical examinations performed from 1985-1996 with those of five matched controls.
They found that on average, several risk factors were more common among individuals with type 2 diabetes, compared with the matched controls “many years before the diagnosis,” Dr. Malmström said. “In particular, BMI [body mass index], fasting triglycerides, fasting glucose, the apo B/apo A-I ratio and inflammatory markers were increased up to 25 years before the diagnosis.”
For example, 25 years before diagnosis, mean fasting plasma glucose in the type 2 diabetes group was higher than controls at 90 mg/dL vs. 86 mg/dL, respectively. By 10 years before diagnosis, that gap had widened to 98 mg/dL vs. 88 mg/dL. At 1 year before diagnosis, the levels were 106 mg/dl vs. 90 mg/dL.
As for fasting triglycerides, high levels earlier in life appeared to be especially risky: Individuals with levels over 124 mg/dL were more likely to develop type 2 diabetes 20 years later, even if they weren’t overweight or had elevated mean fasting glucose levels.
At 25 years before diagnosis, the type 2 diabetes group had mean fasting triglyceride levels of 120 mg/dL vs. 89 mg/dL in the control group. And at 1 year before diagnosis, the difference had widened to 146 mg/dL vs. 106 mg/dL.
Researchers found signs of higher levels of fructosamine – a marker of glycemic levels over an extended period of time (2-3 weeks) – at about 15 years before diagnosis. According to Dr. Malmström, this finding suggests that “glucose metabolism was starting to become more disturbed later than the changes in fasting glucose, but still many years before the type 2 diabetes diagnosis.”
He speculated that early signs of type 2 diabetes revealed by the study are related to genetic predisposition. “The risk of developing the disease presents early with increased BMI and dyslipidemia, which in turn leads to successively decreased insulin sensitivity,” he said.
One step for future research, he added, would be to “elaborate on these early changes in risk factors and create a risk score based on a few easily available factors in clinical settings.”
The study was funded by Sweden’s Gunnar and Ingmar Jungner Foundation for Laboratory Medicine. Dr. Malmström reported no relevant disclosures.
SAN DIEGO – Based on their analysis of a cohort of more than half a million people, Swedish researchers now believe that mildly elevated fasting plasma glucose and triglyceride levels could indicate an increased risk for type 2 diabetes a quarter-century before diagnosis.
“Previous studies have shown that risk factors for type 2 diabetes, including obesity and elevated fasting glucose, may be present up to 10 years before disease onset. Our study extends this period to more than 20 years before diagnosis,” said the study’s lead author Håkan Malmström, PhD, an epidemiologist with the Karolinska Institute, Stockholm. “Even small elevations in subjects over time early in life may be important to recognize, in particular for people who are overweight or obese.” The study findings were presented in an oral presentation at the scientific sessions of the American Diabetes Association.
The researchers identified 47,997 new type 2 diabetes cases in a Swedish cohort of 537,119 people tracked from 1985-2012. For each case, they compared risk factors from clinical examinations performed from 1985-1996 with those of five matched controls.
They found that on average, several risk factors were more common among individuals with type 2 diabetes, compared with the matched controls “many years before the diagnosis,” Dr. Malmström said. “In particular, BMI [body mass index], fasting triglycerides, fasting glucose, the apo B/apo A-I ratio and inflammatory markers were increased up to 25 years before the diagnosis.”
For example, 25 years before diagnosis, mean fasting plasma glucose in the type 2 diabetes group was higher than controls at 90 mg/dL vs. 86 mg/dL, respectively. By 10 years before diagnosis, that gap had widened to 98 mg/dL vs. 88 mg/dL. At 1 year before diagnosis, the levels were 106 mg/dl vs. 90 mg/dL.
As for fasting triglycerides, high levels earlier in life appeared to be especially risky: Individuals with levels over 124 mg/dL were more likely to develop type 2 diabetes 20 years later, even if they weren’t overweight or had elevated mean fasting glucose levels.
At 25 years before diagnosis, the type 2 diabetes group had mean fasting triglyceride levels of 120 mg/dL vs. 89 mg/dL in the control group. And at 1 year before diagnosis, the difference had widened to 146 mg/dL vs. 106 mg/dL.
Researchers found signs of higher levels of fructosamine – a marker of glycemic levels over an extended period of time (2-3 weeks) – at about 15 years before diagnosis. According to Dr. Malmström, this finding suggests that “glucose metabolism was starting to become more disturbed later than the changes in fasting glucose, but still many years before the type 2 diabetes diagnosis.”
He speculated that early signs of type 2 diabetes revealed by the study are related to genetic predisposition. “The risk of developing the disease presents early with increased BMI and dyslipidemia, which in turn leads to successively decreased insulin sensitivity,” he said.
One step for future research, he added, would be to “elaborate on these early changes in risk factors and create a risk score based on a few easily available factors in clinical settings.”
The study was funded by Sweden’s Gunnar and Ingmar Jungner Foundation for Laboratory Medicine. Dr. Malmström reported no relevant disclosures.
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