Key clinical point: Lapses in the use of MS disease-modifying oral therapy increases the risk for relapse, hospitalization, emergency department visits, and outpatient visits, and leads to higher healthcare costs.

Major finding: Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).

Study details: A claims database study of 8,779 patients with MS during 2011-2015

Disclosures: EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.

Citation: REPORTING FROM CMSC 2019

Key clinical point: Lapses in the use of MS disease-modifying oral therapy increases the risk for relapse, hospitalization, emergency department visits, and outpatient visits, and leads to higher healthcare costs.

Major finding: Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).

Study details: A claims database study of 8,779 patients with MS during 2011-2015

Disclosures: EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.

Citation: REPORTING FROM CMSC 2019

Key clinical point: Lapses in the use of MS disease-modifying oral therapy increases the risk for relapse, hospitalization, emergency department visits, and outpatient visits, and leads to higher healthcare costs.

Major finding: Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).

Study details: A claims database study of 8,779 patients with MS during 2011-2015

Disclosures: EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.

Citation: REPORTING FROM CMSC 2019

Key clinical point: Adherence to current oral therapies for multiple sclerosis (MS) is poor.

Major finding: Almost half of patients with MS discontinue their initial oral therapy.

Study details: A retrospective administrative claims study of 8,251 patients with MS.

Disclosures: The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

Citation: Nicholas J et al. CMSC 2019. Abstract DXT34.

Key clinical point: Adherence to current oral therapies for multiple sclerosis (MS) is poor.

Major finding: Almost half of patients with MS discontinue their initial oral therapy.

Study details: A retrospective administrative claims study of 8,251 patients with MS.

Disclosures: The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

Citation: Nicholas J et al. CMSC 2019. Abstract DXT34.

Key clinical point: Adherence to current oral therapies for multiple sclerosis (MS) is poor.

Major finding: Almost half of patients with MS discontinue their initial oral therapy.

Study details: A retrospective administrative claims study of 8,251 patients with MS.

Disclosures: The authors received no financial support for this study. Dr. Nicholas reported receiving grant support from EMD Serono.

Citation: Nicholas J et al. CMSC 2019. Abstract DXT34.

The rate of suicide associated with residential long-term care (LTC) in adults aged 55 years and older may be significantly higher than the injury location coding of the National Violent Death Reporting System (NVDRS) suggests, according to new research.

©Thinkstock

The Centers for Disease Control and Prevention reports that there are about 16,000 nursing homes and 31,000 assisted living facilities in the United States and they currently house about 25% of all Medicare beneficiaries. “As such, residential LTC may be a potential location for identifying individuals at high risk of self-harm and for implementing interventions to reduce suicide risk, wrote Briana Mezuk, PhD, and associates from the University of Michigan, Ann Arbor. The study was published in JAMA Network Open.

Dr. Mezuk and colleagues conducted a cross-sectional, epidemiologic study using a natural language–processing algorithm to analyze restricted-access data from the NVDRS between 2003 and 2015. A total of 47,759 suicides and undetermined deaths in adults aged 55 years and older from 27 states were included in the analysis (median age, 64 years; 77.6% male; 90.0% non-Hispanic white).

The algorithm identified 1,037 (2.2% of the total) suicide deaths associated with LTC, with 428 occurring in adults living in LTC, 449 occurring during the transition into or out of LTC, and 160 otherwise associated with LTC. Decedents in this group had a median age of 79 years, were 73.8% male, and were 94.3% non-Hispanic white. The number of suicide deaths varied widely from year to year, but no trend was found in the change over the study period.

Deaths while living in LTC were more likely among women, which the investigators noted is to be expected because LTC residents are disproportionately women. Death while transitioning into or out of LTC was more likely among adults who previously had expressed suicide ideation and had a physical health problem cited as a contributing circumstance. Death otherwise associated with LTC was more likely in adults who were married or in a relationship, had a depressed mood, and had a recent crisis cited as a contributing factor.

“Living in LTC or transitioning to LTC is also correlated with a host of characteristics that are established risk factors for suicide,” the investigators noted. “As such, living in LTC or LTC transitions may be a marker of underlying risk, rather than a unique risk factor per se.”

In further analysis, the investigators compared the number of suicide deaths the algorithm identified as occurring within an LTC facility (n = 428) with the injury location code SRF (supervised residential facility; n = 263) and the death location code LTC/nursing home (n = 567) within the NVDRS. Of the 263 SRF injuries, 106 were identified as occurring within a LTC facility by the algorithm. The agreement between the algorithm and the SRF coding was poor (kappa statistic, 0.30; 95% confidence interval, 0.26-0.35).

“Leaders in the field have continued to call for a shift away from a medicalized paradigm of residential LTC toward institutional practices that instead focus on fostering meaningful interactions between residents, promote engagement in care, and enhance quality of life. In addition, existing, scalable programs that support older adults living in the community offer the potential to promote quality of life for older adults who may be considering transitioning into or out of residential LTC,” the investigators concluded. “These findings emphasize the importance of such efforts for the mental health of older adults.”

The study was supported by a grant from the National Institute of Mental Health. The investigators reported no conflicts of interest.

[email protected]

SOURCE: Mezuk B et al. JAMA Netw Open. 2019 Jun 14. doi: 10.1001/jamanetworkopen.2019.5627.

The rate of suicide associated with residential long-term care (LTC) in adults aged 55 years and older may be significantly higher than the injury location coding of the National Violent Death Reporting System (NVDRS) suggests, according to new research.

©Thinkstock

The Centers for Disease Control and Prevention reports that there are about 16,000 nursing homes and 31,000 assisted living facilities in the United States and they currently house about 25% of all Medicare beneficiaries. “As such, residential LTC may be a potential location for identifying individuals at high risk of self-harm and for implementing interventions to reduce suicide risk, wrote Briana Mezuk, PhD, and associates from the University of Michigan, Ann Arbor. The study was published in JAMA Network Open.

Dr. Mezuk and colleagues conducted a cross-sectional, epidemiologic study using a natural language–processing algorithm to analyze restricted-access data from the NVDRS between 2003 and 2015. A total of 47,759 suicides and undetermined deaths in adults aged 55 years and older from 27 states were included in the analysis (median age, 64 years; 77.6% male; 90.0% non-Hispanic white).

The algorithm identified 1,037 (2.2% of the total) suicide deaths associated with LTC, with 428 occurring in adults living in LTC, 449 occurring during the transition into or out of LTC, and 160 otherwise associated with LTC. Decedents in this group had a median age of 79 years, were 73.8% male, and were 94.3% non-Hispanic white. The number of suicide deaths varied widely from year to year, but no trend was found in the change over the study period.

Deaths while living in LTC were more likely among women, which the investigators noted is to be expected because LTC residents are disproportionately women. Death while transitioning into or out of LTC was more likely among adults who previously had expressed suicide ideation and had a physical health problem cited as a contributing circumstance. Death otherwise associated with LTC was more likely in adults who were married or in a relationship, had a depressed mood, and had a recent crisis cited as a contributing factor.

“Living in LTC or transitioning to LTC is also correlated with a host of characteristics that are established risk factors for suicide,” the investigators noted. “As such, living in LTC or LTC transitions may be a marker of underlying risk, rather than a unique risk factor per se.”

In further analysis, the investigators compared the number of suicide deaths the algorithm identified as occurring within an LTC facility (n = 428) with the injury location code SRF (supervised residential facility; n = 263) and the death location code LTC/nursing home (n = 567) within the NVDRS. Of the 263 SRF injuries, 106 were identified as occurring within a LTC facility by the algorithm. The agreement between the algorithm and the SRF coding was poor (kappa statistic, 0.30; 95% confidence interval, 0.26-0.35).

“Leaders in the field have continued to call for a shift away from a medicalized paradigm of residential LTC toward institutional practices that instead focus on fostering meaningful interactions between residents, promote engagement in care, and enhance quality of life. In addition, existing, scalable programs that support older adults living in the community offer the potential to promote quality of life for older adults who may be considering transitioning into or out of residential LTC,” the investigators concluded. “These findings emphasize the importance of such efforts for the mental health of older adults.”

The study was supported by a grant from the National Institute of Mental Health. The investigators reported no conflicts of interest.

[email protected]

SOURCE: Mezuk B et al. JAMA Netw Open. 2019 Jun 14. doi: 10.1001/jamanetworkopen.2019.5627.

The rate of suicide associated with residential long-term care (LTC) in adults aged 55 years and older may be significantly higher than the injury location coding of the National Violent Death Reporting System (NVDRS) suggests, according to new research.

©Thinkstock

The Centers for Disease Control and Prevention reports that there are about 16,000 nursing homes and 31,000 assisted living facilities in the United States and they currently house about 25% of all Medicare beneficiaries. “As such, residential LTC may be a potential location for identifying individuals at high risk of self-harm and for implementing interventions to reduce suicide risk, wrote Briana Mezuk, PhD, and associates from the University of Michigan, Ann Arbor. The study was published in JAMA Network Open.

Dr. Mezuk and colleagues conducted a cross-sectional, epidemiologic study using a natural language–processing algorithm to analyze restricted-access data from the NVDRS between 2003 and 2015. A total of 47,759 suicides and undetermined deaths in adults aged 55 years and older from 27 states were included in the analysis (median age, 64 years; 77.6% male; 90.0% non-Hispanic white).

The algorithm identified 1,037 (2.2% of the total) suicide deaths associated with LTC, with 428 occurring in adults living in LTC, 449 occurring during the transition into or out of LTC, and 160 otherwise associated with LTC. Decedents in this group had a median age of 79 years, were 73.8% male, and were 94.3% non-Hispanic white. The number of suicide deaths varied widely from year to year, but no trend was found in the change over the study period.

Deaths while living in LTC were more likely among women, which the investigators noted is to be expected because LTC residents are disproportionately women. Death while transitioning into or out of LTC was more likely among adults who previously had expressed suicide ideation and had a physical health problem cited as a contributing circumstance. Death otherwise associated with LTC was more likely in adults who were married or in a relationship, had a depressed mood, and had a recent crisis cited as a contributing factor.

“Living in LTC or transitioning to LTC is also correlated with a host of characteristics that are established risk factors for suicide,” the investigators noted. “As such, living in LTC or LTC transitions may be a marker of underlying risk, rather than a unique risk factor per se.”

In further analysis, the investigators compared the number of suicide deaths the algorithm identified as occurring within an LTC facility (n = 428) with the injury location code SRF (supervised residential facility; n = 263) and the death location code LTC/nursing home (n = 567) within the NVDRS. Of the 263 SRF injuries, 106 were identified as occurring within a LTC facility by the algorithm. The agreement between the algorithm and the SRF coding was poor (kappa statistic, 0.30; 95% confidence interval, 0.26-0.35).

“Leaders in the field have continued to call for a shift away from a medicalized paradigm of residential LTC toward institutional practices that instead focus on fostering meaningful interactions between residents, promote engagement in care, and enhance quality of life. In addition, existing, scalable programs that support older adults living in the community offer the potential to promote quality of life for older adults who may be considering transitioning into or out of residential LTC,” the investigators concluded. “These findings emphasize the importance of such efforts for the mental health of older adults.”

The study was supported by a grant from the National Institute of Mental Health. The investigators reported no conflicts of interest.

[email protected]

SOURCE: Mezuk B et al. JAMA Netw Open. 2019 Jun 14. doi: 10.1001/jamanetworkopen.2019.5627.

Psychotherapeutic treatments appear to be superior to pharmacologic treatments for adults with PTSD, recent research from a meta-analysis shows.

“Our results confirm the recommendations of many treatment guidelines, that psychotherapeutic treatments should be preferred as first-line treatments, and we found limited evidence to recommend pharmacological treatments as monotherapies, when sustained and long-term symptom improvement is intended,” Jasmin Merz, of the division of clinical psychology and psychotherapy and the department of psychology at the University of Basel (Switzerland), and colleagues wrote. The study was published in JAMA Psychiatry.

The researchers noted, however, that no intervention was found to be superior at the end of treatment and emphasized that more research for long-term outcomes are needed, as few studies directly compared the interventions long term or were underpowered.

Ms. Merz and colleagues identified 12 randomized clinical trials with 922 participants out of a total of 11,417 records in the MEDLINE, Embase, PsycINFO, PSYNDEX, and Cochrane Controlled Trials Register between January 1980 and February 2018. Overall, there were 23 direct comparisons between psychotherapeutic and pharmacologic treatments for PTSD, as well as for combination treatment, and researchers evaluated the comparative benefit across studies with random effects network and pairwise meta-analyses.

In short-term findings, no single treatment approach proved superior. However, in long-term findings, psychotherapeutic treatments were deemed superior to pharmacologic treatments in the network meta-analysis (standard mean difference, –0.83; 95% confidence interval, –1.59 to –0.07) and in the pairwise meta-analysis (95% CI, –1.18 to –0.09) in three randomized, controlled trials with the longest follow-up data available.

Combined treatment was not significantly superior to psychotherapeutic treatment in long-term results but were found to have better outcomes in the network meta-analysis (95% CI, −1.87 to −0.04). In addition, data from two randomized clinical trials showed a “large but nonsignificant benefit” to combined treatments in the pairwise meta-analysis (95% CI, –2.77 to –0.72).

“The differences in findings at the end of treatment and at long-term follow-up highlight the necessity to include long-term follow-up data when evaluating the comparative benefit of treatments, because the treatment outcomes at the end of treatment may differ fundamentally from long-term findings,” the researchers wrote. “Thus, focusing on results at the end of treatment and founding treatment recommendations on short-term data only, as done for instance in previous meta-analyses, may lead to false conclusions.”

One of the authors reported receiving personal fees from JAMA Psychiatry for performing statistical reviews. The other authors reported no relevant conflicts of interest.

SOURCE: Merz J et al. JAMA Psychiatry. 2019 Jun 12. doi: 10.1001/jamapsychiatry.2019.0951.

Psychotherapeutic treatments appear to be superior to pharmacologic treatments for adults with PTSD, recent research from a meta-analysis shows.

“Our results confirm the recommendations of many treatment guidelines, that psychotherapeutic treatments should be preferred as first-line treatments, and we found limited evidence to recommend pharmacological treatments as monotherapies, when sustained and long-term symptom improvement is intended,” Jasmin Merz, of the division of clinical psychology and psychotherapy and the department of psychology at the University of Basel (Switzerland), and colleagues wrote. The study was published in JAMA Psychiatry.

The researchers noted, however, that no intervention was found to be superior at the end of treatment and emphasized that more research for long-term outcomes are needed, as few studies directly compared the interventions long term or were underpowered.

Ms. Merz and colleagues identified 12 randomized clinical trials with 922 participants out of a total of 11,417 records in the MEDLINE, Embase, PsycINFO, PSYNDEX, and Cochrane Controlled Trials Register between January 1980 and February 2018. Overall, there were 23 direct comparisons between psychotherapeutic and pharmacologic treatments for PTSD, as well as for combination treatment, and researchers evaluated the comparative benefit across studies with random effects network and pairwise meta-analyses.

In short-term findings, no single treatment approach proved superior. However, in long-term findings, psychotherapeutic treatments were deemed superior to pharmacologic treatments in the network meta-analysis (standard mean difference, –0.83; 95% confidence interval, –1.59 to –0.07) and in the pairwise meta-analysis (95% CI, –1.18 to –0.09) in three randomized, controlled trials with the longest follow-up data available.

Combined treatment was not significantly superior to psychotherapeutic treatment in long-term results but were found to have better outcomes in the network meta-analysis (95% CI, −1.87 to −0.04). In addition, data from two randomized clinical trials showed a “large but nonsignificant benefit” to combined treatments in the pairwise meta-analysis (95% CI, –2.77 to –0.72).

“The differences in findings at the end of treatment and at long-term follow-up highlight the necessity to include long-term follow-up data when evaluating the comparative benefit of treatments, because the treatment outcomes at the end of treatment may differ fundamentally from long-term findings,” the researchers wrote. “Thus, focusing on results at the end of treatment and founding treatment recommendations on short-term data only, as done for instance in previous meta-analyses, may lead to false conclusions.”

One of the authors reported receiving personal fees from JAMA Psychiatry for performing statistical reviews. The other authors reported no relevant conflicts of interest.

SOURCE: Merz J et al. JAMA Psychiatry. 2019 Jun 12. doi: 10.1001/jamapsychiatry.2019.0951.

Psychotherapeutic treatments appear to be superior to pharmacologic treatments for adults with PTSD, recent research from a meta-analysis shows.

“Our results confirm the recommendations of many treatment guidelines, that psychotherapeutic treatments should be preferred as first-line treatments, and we found limited evidence to recommend pharmacological treatments as monotherapies, when sustained and long-term symptom improvement is intended,” Jasmin Merz, of the division of clinical psychology and psychotherapy and the department of psychology at the University of Basel (Switzerland), and colleagues wrote. The study was published in JAMA Psychiatry.

The researchers noted, however, that no intervention was found to be superior at the end of treatment and emphasized that more research for long-term outcomes are needed, as few studies directly compared the interventions long term or were underpowered.

Ms. Merz and colleagues identified 12 randomized clinical trials with 922 participants out of a total of 11,417 records in the MEDLINE, Embase, PsycINFO, PSYNDEX, and Cochrane Controlled Trials Register between January 1980 and February 2018. Overall, there were 23 direct comparisons between psychotherapeutic and pharmacologic treatments for PTSD, as well as for combination treatment, and researchers evaluated the comparative benefit across studies with random effects network and pairwise meta-analyses.

In short-term findings, no single treatment approach proved superior. However, in long-term findings, psychotherapeutic treatments were deemed superior to pharmacologic treatments in the network meta-analysis (standard mean difference, –0.83; 95% confidence interval, –1.59 to –0.07) and in the pairwise meta-analysis (95% CI, –1.18 to –0.09) in three randomized, controlled trials with the longest follow-up data available.

Combined treatment was not significantly superior to psychotherapeutic treatment in long-term results but were found to have better outcomes in the network meta-analysis (95% CI, −1.87 to −0.04). In addition, data from two randomized clinical trials showed a “large but nonsignificant benefit” to combined treatments in the pairwise meta-analysis (95% CI, –2.77 to –0.72).

“The differences in findings at the end of treatment and at long-term follow-up highlight the necessity to include long-term follow-up data when evaluating the comparative benefit of treatments, because the treatment outcomes at the end of treatment may differ fundamentally from long-term findings,” the researchers wrote. “Thus, focusing on results at the end of treatment and founding treatment recommendations on short-term data only, as done for instance in previous meta-analyses, may lead to false conclusions.”

One of the authors reported receiving personal fees from JAMA Psychiatry for performing statistical reviews. The other authors reported no relevant conflicts of interest.

SOURCE: Merz J et al. JAMA Psychiatry. 2019 Jun 12. doi: 10.1001/jamapsychiatry.2019.0951.

As California lawmakers attempt to tighten the rules on childhood vaccinations, they’re getting pushback from unexpected quarters: high-profile officials who support vaccines.

Choreograph/Thinkstock

In the past few weeks, Democratic Gov. Gavin Newsom and the members of the Medical Board of California have questioned a bill that would give the California Department of Public Health authority to decide whether a child can skip routine vaccinations.

Anti-vaccine activists have capitalized on these moments, plastering Facebook pages and social media with praise for the officials’ statements.

But those officials are not against vaccinations. In fact, they have made clear they’re committed to vaccines, and to dealing with the problem the bill is supposed to fix — doctors providing kids with medical exemptions for reasons that don’t meet federal standards.

“Having been in public health for a long time, I am a huge supporter of vaccines,” said Michelle Bholat, MD, a family medicine physician in Santa Monica and until recently a member of the medical board, which has oversight over physicians and their licenses.

What concerns her, she said at a late-May meeting of the board, was the measure’s potential effect on doctor-patient relationships and the particulars of who would qualify for a medical exemption.

Pediatrician and State Sen. Richard Pan (D-Sacramento) introduced the bill to address a spike in the number of children who have been granted what he calls “fake” medical exemptions from vaccinations; more than five times as many kids have medical exemptions this past school year than in 2015-16.

SB 276 would give the final say on medical exemption applications to the state public health department, which would be required to follow guidelines established by the Centers for Disease Control and Prevention. Any exemptions provided by doctors would be subject to approval — or denial — by the department.

The only other state that gives control of vaccine exemptions to a public health agency is West Virginia.

The measure passed the state Senate in May and is awaiting consideration in the state Assembly.

The debate over the measure comes as new state data show that the percentage of kindergartners who had all their recommended shots fell for the second straight year, largely due to an increase in medical exemptions written by doctors.

During the past school year, the share of fully vaccinated kindergartners dropped to 94.8%, down from 95.6% in 2016-17, putting the state in potentially dangerous territory — officials recommend 90%-95% coverage for community immunity.

And as vaccination rates dip, measles is spreading nationwide. In the largest outbreak since 1992, more than 1,000 people have been infected across the country this year through June 5, including 51 in California.

Nearly 3 years ago, California enacted a law by Sen. Pan that bars parents from citing personal or religious beliefs to avoid vaccinating their children. Children could be exempted only on medical grounds if the shots were harmful to their health.

That ban improved vaccination rates, though progress has been slipping.

Today, many of the schools that had the highest rates of unvaccinated students before the law took effect still do. Doctors have broad authority to grant medical exemptions from vaccination; some wield that power liberally and sometimes for cash, signing dozens or hundreds of exemptions for children, sometimes in far-off communities.

Sen. Pan’s bill would crack down on this practice and has the strong support of the medical establishment. It was cosponsored by two powerful doctor associations, the American Academy of Pediatrics, California, and the California Medical Association.

“We want to make sure unscrupulous physicians aren’t making medical exemptions for money,” said David Aizuss, MD, president of the California Medical Association. “The idea of the bill is to protect a real personal medical exemption, where kids are on chemotherapy or have an immunological response.”

But it has its critics — and this time, they extend beyond the small but fervent group of people who continue to question the extensive scientific evidence that shows vaccines are safe. And although raising concerns is typical in the legislative process, their criticisms take on outsize importance with a subject as explosive as vaccines.

The biggest name among the new critics is Gov. Newsom, who said he’s worried about interfering with the doctor-patient relationship. “I like doctor-patient relationships. Bureaucratic relationships are more challenging for me,” he said at the state Democratic Party convention in early June.

“I’m a parent; I don’t want someone that the governor of California appointed to make a decision for my family.”

State Sen. Ben Allen (D-Santa Monica), a cosponsor of Sen. Pan’s previous legislation, abstained from voting on the new measure last month, saying he’d made commitments during the previous fight to leave medical exemptions to the discretion of doctors.

Last month, the Medical Board of California offered just lukewarm support, and only to portions of the bill, after listening to 200 members of the public speak against it for more than 2 hours.

The board members called on Sen. Pan to address a variety of concerns, from the potential oversight role the state public health department might play, to the proposed guidelines for medical exemptions.

They agreed on one thing: It should be easier for the board to investigate complaints of questionable medical exemptions. To look into complaints, the board needs to see medical records. To get those records, it generally needs permission from patients or their guardians, something parents who have sought medical exemptions are often unwilling to provide. The bill would give the board access to these records.

One physician, Bob Sears, MD, in Orange County, a well-known opponent to vaccine mandates, was put on probation in 2018 for writing an exemption for a 2-year-old without taking any medical history. Since 2016, at least 173 complaints against physicians for inappropriate exemptions have been filed with the state medical board, with more than 100 currently under investigation, the board said.

Medical exemptions for California kids are clustered in certain communities and schools. In Humboldt County, 5.8% of kindergartners have medical exemptions from shots, according to the new state data. In Nevada County, the rate is 10.6%. All told, nearly one-third of the state’s counties have fallen below 95% immunity from measles.

Dr. Aizuss of the California Medical Association said the organization is working with Gov. Newsom’s office and the medical board, among others, to update the bill so that it will be “workable, effective, and supported by the governor.

“I think that our goal is the same,” he said. “The idea of the bill is to protect ... the sanctity of the true physician-patient relationship, as opposed to a relationship where physicians were granting the medical exemption for a fee, which is not a true physician-patient relationship.”
 

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. California Healthline reporter Ana B. Ibarra contributed to this report.

As California lawmakers attempt to tighten the rules on childhood vaccinations, they’re getting pushback from unexpected quarters: high-profile officials who support vaccines.

Choreograph/Thinkstock

In the past few weeks, Democratic Gov. Gavin Newsom and the members of the Medical Board of California have questioned a bill that would give the California Department of Public Health authority to decide whether a child can skip routine vaccinations.

Anti-vaccine activists have capitalized on these moments, plastering Facebook pages and social media with praise for the officials’ statements.

But those officials are not against vaccinations. In fact, they have made clear they’re committed to vaccines, and to dealing with the problem the bill is supposed to fix — doctors providing kids with medical exemptions for reasons that don’t meet federal standards.

“Having been in public health for a long time, I am a huge supporter of vaccines,” said Michelle Bholat, MD, a family medicine physician in Santa Monica and until recently a member of the medical board, which has oversight over physicians and their licenses.

What concerns her, she said at a late-May meeting of the board, was the measure’s potential effect on doctor-patient relationships and the particulars of who would qualify for a medical exemption.

Pediatrician and State Sen. Richard Pan (D-Sacramento) introduced the bill to address a spike in the number of children who have been granted what he calls “fake” medical exemptions from vaccinations; more than five times as many kids have medical exemptions this past school year than in 2015-16.

SB 276 would give the final say on medical exemption applications to the state public health department, which would be required to follow guidelines established by the Centers for Disease Control and Prevention. Any exemptions provided by doctors would be subject to approval — or denial — by the department.

The only other state that gives control of vaccine exemptions to a public health agency is West Virginia.

The measure passed the state Senate in May and is awaiting consideration in the state Assembly.

The debate over the measure comes as new state data show that the percentage of kindergartners who had all their recommended shots fell for the second straight year, largely due to an increase in medical exemptions written by doctors.

During the past school year, the share of fully vaccinated kindergartners dropped to 94.8%, down from 95.6% in 2016-17, putting the state in potentially dangerous territory — officials recommend 90%-95% coverage for community immunity.

And as vaccination rates dip, measles is spreading nationwide. In the largest outbreak since 1992, more than 1,000 people have been infected across the country this year through June 5, including 51 in California.

Nearly 3 years ago, California enacted a law by Sen. Pan that bars parents from citing personal or religious beliefs to avoid vaccinating their children. Children could be exempted only on medical grounds if the shots were harmful to their health.

That ban improved vaccination rates, though progress has been slipping.

Today, many of the schools that had the highest rates of unvaccinated students before the law took effect still do. Doctors have broad authority to grant medical exemptions from vaccination; some wield that power liberally and sometimes for cash, signing dozens or hundreds of exemptions for children, sometimes in far-off communities.

Sen. Pan’s bill would crack down on this practice and has the strong support of the medical establishment. It was cosponsored by two powerful doctor associations, the American Academy of Pediatrics, California, and the California Medical Association.

“We want to make sure unscrupulous physicians aren’t making medical exemptions for money,” said David Aizuss, MD, president of the California Medical Association. “The idea of the bill is to protect a real personal medical exemption, where kids are on chemotherapy or have an immunological response.”

But it has its critics — and this time, they extend beyond the small but fervent group of people who continue to question the extensive scientific evidence that shows vaccines are safe. And although raising concerns is typical in the legislative process, their criticisms take on outsize importance with a subject as explosive as vaccines.

The biggest name among the new critics is Gov. Newsom, who said he’s worried about interfering with the doctor-patient relationship. “I like doctor-patient relationships. Bureaucratic relationships are more challenging for me,” he said at the state Democratic Party convention in early June.

“I’m a parent; I don’t want someone that the governor of California appointed to make a decision for my family.”

State Sen. Ben Allen (D-Santa Monica), a cosponsor of Sen. Pan’s previous legislation, abstained from voting on the new measure last month, saying he’d made commitments during the previous fight to leave medical exemptions to the discretion of doctors.

Last month, the Medical Board of California offered just lukewarm support, and only to portions of the bill, after listening to 200 members of the public speak against it for more than 2 hours.

The board members called on Sen. Pan to address a variety of concerns, from the potential oversight role the state public health department might play, to the proposed guidelines for medical exemptions.

They agreed on one thing: It should be easier for the board to investigate complaints of questionable medical exemptions. To look into complaints, the board needs to see medical records. To get those records, it generally needs permission from patients or their guardians, something parents who have sought medical exemptions are often unwilling to provide. The bill would give the board access to these records.

One physician, Bob Sears, MD, in Orange County, a well-known opponent to vaccine mandates, was put on probation in 2018 for writing an exemption for a 2-year-old without taking any medical history. Since 2016, at least 173 complaints against physicians for inappropriate exemptions have been filed with the state medical board, with more than 100 currently under investigation, the board said.

Medical exemptions for California kids are clustered in certain communities and schools. In Humboldt County, 5.8% of kindergartners have medical exemptions from shots, according to the new state data. In Nevada County, the rate is 10.6%. All told, nearly one-third of the state’s counties have fallen below 95% immunity from measles.

Dr. Aizuss of the California Medical Association said the organization is working with Gov. Newsom’s office and the medical board, among others, to update the bill so that it will be “workable, effective, and supported by the governor.

“I think that our goal is the same,” he said. “The idea of the bill is to protect ... the sanctity of the true physician-patient relationship, as opposed to a relationship where physicians were granting the medical exemption for a fee, which is not a true physician-patient relationship.”
 

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. California Healthline reporter Ana B. Ibarra contributed to this report.

As California lawmakers attempt to tighten the rules on childhood vaccinations, they’re getting pushback from unexpected quarters: high-profile officials who support vaccines.

Choreograph/Thinkstock

In the past few weeks, Democratic Gov. Gavin Newsom and the members of the Medical Board of California have questioned a bill that would give the California Department of Public Health authority to decide whether a child can skip routine vaccinations.

Anti-vaccine activists have capitalized on these moments, plastering Facebook pages and social media with praise for the officials’ statements.

But those officials are not against vaccinations. In fact, they have made clear they’re committed to vaccines, and to dealing with the problem the bill is supposed to fix — doctors providing kids with medical exemptions for reasons that don’t meet federal standards.

“Having been in public health for a long time, I am a huge supporter of vaccines,” said Michelle Bholat, MD, a family medicine physician in Santa Monica and until recently a member of the medical board, which has oversight over physicians and their licenses.

What concerns her, she said at a late-May meeting of the board, was the measure’s potential effect on doctor-patient relationships and the particulars of who would qualify for a medical exemption.

Pediatrician and State Sen. Richard Pan (D-Sacramento) introduced the bill to address a spike in the number of children who have been granted what he calls “fake” medical exemptions from vaccinations; more than five times as many kids have medical exemptions this past school year than in 2015-16.

SB 276 would give the final say on medical exemption applications to the state public health department, which would be required to follow guidelines established by the Centers for Disease Control and Prevention. Any exemptions provided by doctors would be subject to approval — or denial — by the department.

The only other state that gives control of vaccine exemptions to a public health agency is West Virginia.

The measure passed the state Senate in May and is awaiting consideration in the state Assembly.

The debate over the measure comes as new state data show that the percentage of kindergartners who had all their recommended shots fell for the second straight year, largely due to an increase in medical exemptions written by doctors.

During the past school year, the share of fully vaccinated kindergartners dropped to 94.8%, down from 95.6% in 2016-17, putting the state in potentially dangerous territory — officials recommend 90%-95% coverage for community immunity.

And as vaccination rates dip, measles is spreading nationwide. In the largest outbreak since 1992, more than 1,000 people have been infected across the country this year through June 5, including 51 in California.

Nearly 3 years ago, California enacted a law by Sen. Pan that bars parents from citing personal or religious beliefs to avoid vaccinating their children. Children could be exempted only on medical grounds if the shots were harmful to their health.

That ban improved vaccination rates, though progress has been slipping.

Today, many of the schools that had the highest rates of unvaccinated students before the law took effect still do. Doctors have broad authority to grant medical exemptions from vaccination; some wield that power liberally and sometimes for cash, signing dozens or hundreds of exemptions for children, sometimes in far-off communities.

Sen. Pan’s bill would crack down on this practice and has the strong support of the medical establishment. It was cosponsored by two powerful doctor associations, the American Academy of Pediatrics, California, and the California Medical Association.

“We want to make sure unscrupulous physicians aren’t making medical exemptions for money,” said David Aizuss, MD, president of the California Medical Association. “The idea of the bill is to protect a real personal medical exemption, where kids are on chemotherapy or have an immunological response.”

But it has its critics — and this time, they extend beyond the small but fervent group of people who continue to question the extensive scientific evidence that shows vaccines are safe. And although raising concerns is typical in the legislative process, their criticisms take on outsize importance with a subject as explosive as vaccines.

The biggest name among the new critics is Gov. Newsom, who said he’s worried about interfering with the doctor-patient relationship. “I like doctor-patient relationships. Bureaucratic relationships are more challenging for me,” he said at the state Democratic Party convention in early June.

“I’m a parent; I don’t want someone that the governor of California appointed to make a decision for my family.”

State Sen. Ben Allen (D-Santa Monica), a cosponsor of Sen. Pan’s previous legislation, abstained from voting on the new measure last month, saying he’d made commitments during the previous fight to leave medical exemptions to the discretion of doctors.

Last month, the Medical Board of California offered just lukewarm support, and only to portions of the bill, after listening to 200 members of the public speak against it for more than 2 hours.

The board members called on Sen. Pan to address a variety of concerns, from the potential oversight role the state public health department might play, to the proposed guidelines for medical exemptions.

They agreed on one thing: It should be easier for the board to investigate complaints of questionable medical exemptions. To look into complaints, the board needs to see medical records. To get those records, it generally needs permission from patients or their guardians, something parents who have sought medical exemptions are often unwilling to provide. The bill would give the board access to these records.

One physician, Bob Sears, MD, in Orange County, a well-known opponent to vaccine mandates, was put on probation in 2018 for writing an exemption for a 2-year-old without taking any medical history. Since 2016, at least 173 complaints against physicians for inappropriate exemptions have been filed with the state medical board, with more than 100 currently under investigation, the board said.

Medical exemptions for California kids are clustered in certain communities and schools. In Humboldt County, 5.8% of kindergartners have medical exemptions from shots, according to the new state data. In Nevada County, the rate is 10.6%. All told, nearly one-third of the state’s counties have fallen below 95% immunity from measles.

Dr. Aizuss of the California Medical Association said the organization is working with Gov. Newsom’s office and the medical board, among others, to update the bill so that it will be “workable, effective, and supported by the governor.

“I think that our goal is the same,” he said. “The idea of the bill is to protect ... the sanctity of the true physician-patient relationship, as opposed to a relationship where physicians were granting the medical exemption for a fee, which is not a true physician-patient relationship.”
 

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. California Healthline reporter Ana B. Ibarra contributed to this report.

It was an unthinkable crime; on July 20, 2012, a 24-year-old neuroscience graduate student* walked into a movie theatre in Aurora, Colo., and began shooting people he had never before seen. Twelve people died and 70 were wounded in this calculated and intricately planned massacre that challenged everything we know about the intersection of mental illness and evil.

So much has been written about mass shooters as we’ve struggled to understand what motivates someone to kill strangers in a public place. The hope is that if we can understand it, then we can prevent it. The topic has been one of great interest to me because it gets quickly linked to advocacy for involuntary psychiatric care: Half of mass murderers suffer from psychiatric disorders and if we could force them to get treatment, then we could prevent these horrific events.

Courtesy Wikimedia Commons/Algr/Creative Commons License

In this case, the perpetrator had been treated by a therapist and two psychiatrists at his university counseling center in the semester before the shooting. There were video recordings of the defendant in his cell, a correctional psychiatrist in the local jail; psychiatric records from an admission to Denver Health Medical Center and two admissions to the Colorado Health Institute at Pueblo (a secure, forensic setting); and neuropsychological testing done by psychologists hired for the case. In all, there was a lot of mental health data, and I’m not aware of any other book that has been written by a psychiatrist about a criminal case where the author testified in the case.

Let me start by saying that the book is well written, very readable, and fascinating. I’d followed parts of the case in the news and had even watched some of the trial being live-streamed, so not all of the information was new, but Dr. Reid has put together the many facts of a perplexing case together in a cohesive way. There’s no literary descriptions or flowery writing; Dr. Reid is a focused writer. He also does a good job of explaining the specifics of Colorado state law to the forensic aspects of the case. In the end, there were nuances of how the shooter came to be found both competent and sane but was spared the death penalty by a single vote. Overall, I found the book haunting, and it would have been a more comfortable read if it were fiction. There was something terribly disconcerting about following along this miserable journey, all the while knowing that the killer ultimately would destroy so many lives and then watching his disconnected existence after the massacre.

As a general adult psychiatrist, I wanted to learn something very specific from this book: What is the recipe for creating a mass murderer and what are the warning signs a psychiatrist should catch? I would like my career to be free of patients who kill. The Aurora shooter’s family life sounded fairly pedestrian. His parents are professionals; there was a boy and a girl in an intact family with attentive parents, and no findings of abuse, torture, neglect, bullying, or anything out of the ordinary.

As a child, the shooter was noted for his kindness, and he was particularly caring toward his younger sister. As he grew older, reports about his personality were conflicting: Some saw him as awkward, and later even as odd, while others described him as normal, especially within a cohort of studious kids. He played on sports teams, was an excellent student, liked nonviolent video games, and while he was not outgoing, he always had some friends, though he shunned them during the semester before the shooting. He was not comfortable with women, but he had one girlfriend in graduate school, and when that relationship broke up, he texted with another classmate about how “hot” she was and that they went hiking together. The breakup may have contributed to the shooter’s unraveling, but if it did, Dr. Reid did not present this as the precipitant, and many young men are awkward with women – and endure breakups and rejection.

While the media said the shooter failed out of school, this was not the case. He did well in his classes but chose not to study for an important oral exam while he devoted his time to gathering weapons for his mission to kill, planning out the details, learning to use firearms, and rigging up a complex explosive system around his apartment. When he failed the oral exam, he was told he could study and retake it in a few weeks. He chose, instead, to withdraw from graduate school.

What stood out for me was that this young man talked about thoughts of killing people. He did so to the point of worrying his psychiatrist: She called in a second psychiatrist for a consultation, alerted the university’s threat assessment team, contacted an out-of-state parent, and considered admitting him on an involuntary hold. While many patients say they might hurt someone if provoked or threatened, few discuss thoughts of killing indiscriminately. But when people do talk about killing, we do our best to flush out their intentions, whether it is a fantasy or a plan, if they’ve been violent before. This shooter had no history of violence, and he hid from the psychiatrist the fact that he was acquiring weapons and actually planning a massacre. His psychiatrist diagnosed him with social anxiety, obsessive-compulsive disorder, and possible schizotypal personality disorder. He was prescribed an antidepressant, and later offered an antipsychotic, which he refused.

Three of the four psychiatrists who evaluated the defendant for the legal proceedings made a diagnosis of schizoaffective disorder. (The fifth psychiatrist for the prosecution never examined the defendant.) Dr. Reid made a diagnosis of schizotypal personality disorder. Everyone agreed that the shooter had a mental illness that influenced his actions. When it came to ascertaining the defendant’s mental state at the time of the crime, there was a glitch: The first psychiatrist for the defense examined the defendant only once, days after the shooting, and not again until 3 years later, right before the trial. His exam was limited: The defense attorney was present in the room, and he had instructed the psychiatrist not to ask about the shooting. The attorney interrupted the interview twice, and it’s not the usual practice to place these conditions on a forensic evaluation. After that exam, there was some misunderstanding about who was in charge of the treatment, and the defendant refused the services of the jail psychiatrist. It was not until 4 months later when the inmate became dehydrated, delirious, and psychotic that he finally was evaluated and treated. Despite the abundance of psychiatric information available, no direct and complete assessment was made by a psychiatrist immediately before the shooting, or in the months right after.

When we try to understand what motivates someone to commit such a heinous act, we look for psychosis. If the person suffers from paranoid delusions and believes his behavior is in self-defense, the behavior becomes understandable and justifiable. Even if it’s less organized, if it is the clear result of a psychotic thought process, we often attribute the behavior to illness. Usually, people with psychosis are too disorganized to enact complex plans, to acquire and learn to use ammunition, to plot out when and where there will be potential victims, and to plot out this degree of planning.

This shooter had an odd belief that if he killed people, he would attain “human capital.” Their deaths might fortify him, increase his value and decrease his suffering, and thereby prevent him from dying by suicide. Dr. Reid talks about whether it’s a delusion, an overvalued idea, or just an unusual belief. The shooter was aware that others don’t agree with this, that they would see it as wrong and criminal, and he thought there was only a 50% chance that it would work. If this were a delusion, it was not one we typically see, nor was it accompanied by more usual perceptual phenomena. Ultimately, there was no consensus on whether the patient was psychotic at the time of the shooting. On antipsychotic medication, he continued to believe that if he killed people that he would attain their human capital. In his book, Dr. Reid concluded that he remained dangerous.

Because the shooter told the university health center psychiatrist that he did not want to be locked up, she considered involuntary hospitalization, but she did not believe he would meet criteria for commitment. I saw nothing that indicated whether he was offered voluntary inpatient care with an explanation that hospital treatment is not the same as being locked up and might help alleviate his suffering. We don’t know if he could have been persuaded to enter the hospital willingly, but I suspect that this would have been difficult to justify to an insurer. There’s nothing to indicate that a hospitalization would have prevented this massacre.

From my perspective, I concluded that if individuals say they are thinking about killing strangers, they may be at risk of violence. This is a much smaller group of people to target for intervention than everyone with mental illness or everyone who is odd. This particular shooter appears to suffer from some type of mental derangement that does not fit neatly into our current psychiatric nomenclature or respond to our current treatments, and thoughtful psychiatric intervention – which he had – could not prevent his actions. It seems the only thing that would have changed this outcome is if someone had discovered his arsenal before July 20, 2012. 

*Please note: The shooter’s name is intentionally omitted from my review. 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

It was an unthinkable crime; on July 20, 2012, a 24-year-old neuroscience graduate student* walked into a movie theatre in Aurora, Colo., and began shooting people he had never before seen. Twelve people died and 70 were wounded in this calculated and intricately planned massacre that challenged everything we know about the intersection of mental illness and evil.

So much has been written about mass shooters as we’ve struggled to understand what motivates someone to kill strangers in a public place. The hope is that if we can understand it, then we can prevent it. The topic has been one of great interest to me because it gets quickly linked to advocacy for involuntary psychiatric care: Half of mass murderers suffer from psychiatric disorders and if we could force them to get treatment, then we could prevent these horrific events.

Courtesy Wikimedia Commons/Algr/Creative Commons License

In this case, the perpetrator had been treated by a therapist and two psychiatrists at his university counseling center in the semester before the shooting. There were video recordings of the defendant in his cell, a correctional psychiatrist in the local jail; psychiatric records from an admission to Denver Health Medical Center and two admissions to the Colorado Health Institute at Pueblo (a secure, forensic setting); and neuropsychological testing done by psychologists hired for the case. In all, there was a lot of mental health data, and I’m not aware of any other book that has been written by a psychiatrist about a criminal case where the author testified in the case.

Let me start by saying that the book is well written, very readable, and fascinating. I’d followed parts of the case in the news and had even watched some of the trial being live-streamed, so not all of the information was new, but Dr. Reid has put together the many facts of a perplexing case together in a cohesive way. There’s no literary descriptions or flowery writing; Dr. Reid is a focused writer. He also does a good job of explaining the specifics of Colorado state law to the forensic aspects of the case. In the end, there were nuances of how the shooter came to be found both competent and sane but was spared the death penalty by a single vote. Overall, I found the book haunting, and it would have been a more comfortable read if it were fiction. There was something terribly disconcerting about following along this miserable journey, all the while knowing that the killer ultimately would destroy so many lives and then watching his disconnected existence after the massacre.

As a general adult psychiatrist, I wanted to learn something very specific from this book: What is the recipe for creating a mass murderer and what are the warning signs a psychiatrist should catch? I would like my career to be free of patients who kill. The Aurora shooter’s family life sounded fairly pedestrian. His parents are professionals; there was a boy and a girl in an intact family with attentive parents, and no findings of abuse, torture, neglect, bullying, or anything out of the ordinary.

As a child, the shooter was noted for his kindness, and he was particularly caring toward his younger sister. As he grew older, reports about his personality were conflicting: Some saw him as awkward, and later even as odd, while others described him as normal, especially within a cohort of studious kids. He played on sports teams, was an excellent student, liked nonviolent video games, and while he was not outgoing, he always had some friends, though he shunned them during the semester before the shooting. He was not comfortable with women, but he had one girlfriend in graduate school, and when that relationship broke up, he texted with another classmate about how “hot” she was and that they went hiking together. The breakup may have contributed to the shooter’s unraveling, but if it did, Dr. Reid did not present this as the precipitant, and many young men are awkward with women – and endure breakups and rejection.

While the media said the shooter failed out of school, this was not the case. He did well in his classes but chose not to study for an important oral exam while he devoted his time to gathering weapons for his mission to kill, planning out the details, learning to use firearms, and rigging up a complex explosive system around his apartment. When he failed the oral exam, he was told he could study and retake it in a few weeks. He chose, instead, to withdraw from graduate school.

What stood out for me was that this young man talked about thoughts of killing people. He did so to the point of worrying his psychiatrist: She called in a second psychiatrist for a consultation, alerted the university’s threat assessment team, contacted an out-of-state parent, and considered admitting him on an involuntary hold. While many patients say they might hurt someone if provoked or threatened, few discuss thoughts of killing indiscriminately. But when people do talk about killing, we do our best to flush out their intentions, whether it is a fantasy or a plan, if they’ve been violent before. This shooter had no history of violence, and he hid from the psychiatrist the fact that he was acquiring weapons and actually planning a massacre. His psychiatrist diagnosed him with social anxiety, obsessive-compulsive disorder, and possible schizotypal personality disorder. He was prescribed an antidepressant, and later offered an antipsychotic, which he refused.

Three of the four psychiatrists who evaluated the defendant for the legal proceedings made a diagnosis of schizoaffective disorder. (The fifth psychiatrist for the prosecution never examined the defendant.) Dr. Reid made a diagnosis of schizotypal personality disorder. Everyone agreed that the shooter had a mental illness that influenced his actions. When it came to ascertaining the defendant’s mental state at the time of the crime, there was a glitch: The first psychiatrist for the defense examined the defendant only once, days after the shooting, and not again until 3 years later, right before the trial. His exam was limited: The defense attorney was present in the room, and he had instructed the psychiatrist not to ask about the shooting. The attorney interrupted the interview twice, and it’s not the usual practice to place these conditions on a forensic evaluation. After that exam, there was some misunderstanding about who was in charge of the treatment, and the defendant refused the services of the jail psychiatrist. It was not until 4 months later when the inmate became dehydrated, delirious, and psychotic that he finally was evaluated and treated. Despite the abundance of psychiatric information available, no direct and complete assessment was made by a psychiatrist immediately before the shooting, or in the months right after.

When we try to understand what motivates someone to commit such a heinous act, we look for psychosis. If the person suffers from paranoid delusions and believes his behavior is in self-defense, the behavior becomes understandable and justifiable. Even if it’s less organized, if it is the clear result of a psychotic thought process, we often attribute the behavior to illness. Usually, people with psychosis are too disorganized to enact complex plans, to acquire and learn to use ammunition, to plot out when and where there will be potential victims, and to plot out this degree of planning.

This shooter had an odd belief that if he killed people, he would attain “human capital.” Their deaths might fortify him, increase his value and decrease his suffering, and thereby prevent him from dying by suicide. Dr. Reid talks about whether it’s a delusion, an overvalued idea, or just an unusual belief. The shooter was aware that others don’t agree with this, that they would see it as wrong and criminal, and he thought there was only a 50% chance that it would work. If this were a delusion, it was not one we typically see, nor was it accompanied by more usual perceptual phenomena. Ultimately, there was no consensus on whether the patient was psychotic at the time of the shooting. On antipsychotic medication, he continued to believe that if he killed people that he would attain their human capital. In his book, Dr. Reid concluded that he remained dangerous.

Because the shooter told the university health center psychiatrist that he did not want to be locked up, she considered involuntary hospitalization, but she did not believe he would meet criteria for commitment. I saw nothing that indicated whether he was offered voluntary inpatient care with an explanation that hospital treatment is not the same as being locked up and might help alleviate his suffering. We don’t know if he could have been persuaded to enter the hospital willingly, but I suspect that this would have been difficult to justify to an insurer. There’s nothing to indicate that a hospitalization would have prevented this massacre.

From my perspective, I concluded that if individuals say they are thinking about killing strangers, they may be at risk of violence. This is a much smaller group of people to target for intervention than everyone with mental illness or everyone who is odd. This particular shooter appears to suffer from some type of mental derangement that does not fit neatly into our current psychiatric nomenclature or respond to our current treatments, and thoughtful psychiatric intervention – which he had – could not prevent his actions. It seems the only thing that would have changed this outcome is if someone had discovered his arsenal before July 20, 2012. 

*Please note: The shooter’s name is intentionally omitted from my review. 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

It was an unthinkable crime; on July 20, 2012, a 24-year-old neuroscience graduate student* walked into a movie theatre in Aurora, Colo., and began shooting people he had never before seen. Twelve people died and 70 were wounded in this calculated and intricately planned massacre that challenged everything we know about the intersection of mental illness and evil.

So much has been written about mass shooters as we’ve struggled to understand what motivates someone to kill strangers in a public place. The hope is that if we can understand it, then we can prevent it. The topic has been one of great interest to me because it gets quickly linked to advocacy for involuntary psychiatric care: Half of mass murderers suffer from psychiatric disorders and if we could force them to get treatment, then we could prevent these horrific events.

Courtesy Wikimedia Commons/Algr/Creative Commons License

In this case, the perpetrator had been treated by a therapist and two psychiatrists at his university counseling center in the semester before the shooting. There were video recordings of the defendant in his cell, a correctional psychiatrist in the local jail; psychiatric records from an admission to Denver Health Medical Center and two admissions to the Colorado Health Institute at Pueblo (a secure, forensic setting); and neuropsychological testing done by psychologists hired for the case. In all, there was a lot of mental health data, and I’m not aware of any other book that has been written by a psychiatrist about a criminal case where the author testified in the case.

Let me start by saying that the book is well written, very readable, and fascinating. I’d followed parts of the case in the news and had even watched some of the trial being live-streamed, so not all of the information was new, but Dr. Reid has put together the many facts of a perplexing case together in a cohesive way. There’s no literary descriptions or flowery writing; Dr. Reid is a focused writer. He also does a good job of explaining the specifics of Colorado state law to the forensic aspects of the case. In the end, there were nuances of how the shooter came to be found both competent and sane but was spared the death penalty by a single vote. Overall, I found the book haunting, and it would have been a more comfortable read if it were fiction. There was something terribly disconcerting about following along this miserable journey, all the while knowing that the killer ultimately would destroy so many lives and then watching his disconnected existence after the massacre.

As a general adult psychiatrist, I wanted to learn something very specific from this book: What is the recipe for creating a mass murderer and what are the warning signs a psychiatrist should catch? I would like my career to be free of patients who kill. The Aurora shooter’s family life sounded fairly pedestrian. His parents are professionals; there was a boy and a girl in an intact family with attentive parents, and no findings of abuse, torture, neglect, bullying, or anything out of the ordinary.

As a child, the shooter was noted for his kindness, and he was particularly caring toward his younger sister. As he grew older, reports about his personality were conflicting: Some saw him as awkward, and later even as odd, while others described him as normal, especially within a cohort of studious kids. He played on sports teams, was an excellent student, liked nonviolent video games, and while he was not outgoing, he always had some friends, though he shunned them during the semester before the shooting. He was not comfortable with women, but he had one girlfriend in graduate school, and when that relationship broke up, he texted with another classmate about how “hot” she was and that they went hiking together. The breakup may have contributed to the shooter’s unraveling, but if it did, Dr. Reid did not present this as the precipitant, and many young men are awkward with women – and endure breakups and rejection.

While the media said the shooter failed out of school, this was not the case. He did well in his classes but chose not to study for an important oral exam while he devoted his time to gathering weapons for his mission to kill, planning out the details, learning to use firearms, and rigging up a complex explosive system around his apartment. When he failed the oral exam, he was told he could study and retake it in a few weeks. He chose, instead, to withdraw from graduate school.

What stood out for me was that this young man talked about thoughts of killing people. He did so to the point of worrying his psychiatrist: She called in a second psychiatrist for a consultation, alerted the university’s threat assessment team, contacted an out-of-state parent, and considered admitting him on an involuntary hold. While many patients say they might hurt someone if provoked or threatened, few discuss thoughts of killing indiscriminately. But when people do talk about killing, we do our best to flush out their intentions, whether it is a fantasy or a plan, if they’ve been violent before. This shooter had no history of violence, and he hid from the psychiatrist the fact that he was acquiring weapons and actually planning a massacre. His psychiatrist diagnosed him with social anxiety, obsessive-compulsive disorder, and possible schizotypal personality disorder. He was prescribed an antidepressant, and later offered an antipsychotic, which he refused.

Three of the four psychiatrists who evaluated the defendant for the legal proceedings made a diagnosis of schizoaffective disorder. (The fifth psychiatrist for the prosecution never examined the defendant.) Dr. Reid made a diagnosis of schizotypal personality disorder. Everyone agreed that the shooter had a mental illness that influenced his actions. When it came to ascertaining the defendant’s mental state at the time of the crime, there was a glitch: The first psychiatrist for the defense examined the defendant only once, days after the shooting, and not again until 3 years later, right before the trial. His exam was limited: The defense attorney was present in the room, and he had instructed the psychiatrist not to ask about the shooting. The attorney interrupted the interview twice, and it’s not the usual practice to place these conditions on a forensic evaluation. After that exam, there was some misunderstanding about who was in charge of the treatment, and the defendant refused the services of the jail psychiatrist. It was not until 4 months later when the inmate became dehydrated, delirious, and psychotic that he finally was evaluated and treated. Despite the abundance of psychiatric information available, no direct and complete assessment was made by a psychiatrist immediately before the shooting, or in the months right after.

When we try to understand what motivates someone to commit such a heinous act, we look for psychosis. If the person suffers from paranoid delusions and believes his behavior is in self-defense, the behavior becomes understandable and justifiable. Even if it’s less organized, if it is the clear result of a psychotic thought process, we often attribute the behavior to illness. Usually, people with psychosis are too disorganized to enact complex plans, to acquire and learn to use ammunition, to plot out when and where there will be potential victims, and to plot out this degree of planning.

This shooter had an odd belief that if he killed people, he would attain “human capital.” Their deaths might fortify him, increase his value and decrease his suffering, and thereby prevent him from dying by suicide. Dr. Reid talks about whether it’s a delusion, an overvalued idea, or just an unusual belief. The shooter was aware that others don’t agree with this, that they would see it as wrong and criminal, and he thought there was only a 50% chance that it would work. If this were a delusion, it was not one we typically see, nor was it accompanied by more usual perceptual phenomena. Ultimately, there was no consensus on whether the patient was psychotic at the time of the shooting. On antipsychotic medication, he continued to believe that if he killed people that he would attain their human capital. In his book, Dr. Reid concluded that he remained dangerous.

Because the shooter told the university health center psychiatrist that he did not want to be locked up, she considered involuntary hospitalization, but she did not believe he would meet criteria for commitment. I saw nothing that indicated whether he was offered voluntary inpatient care with an explanation that hospital treatment is not the same as being locked up and might help alleviate his suffering. We don’t know if he could have been persuaded to enter the hospital willingly, but I suspect that this would have been difficult to justify to an insurer. There’s nothing to indicate that a hospitalization would have prevented this massacre.

From my perspective, I concluded that if individuals say they are thinking about killing strangers, they may be at risk of violence. This is a much smaller group of people to target for intervention than everyone with mental illness or everyone who is odd. This particular shooter appears to suffer from some type of mental derangement that does not fit neatly into our current psychiatric nomenclature or respond to our current treatments, and thoughtful psychiatric intervention – which he had – could not prevent his actions. It seems the only thing that would have changed this outcome is if someone had discovered his arsenal before July 20, 2012. 

*Please note: The shooter’s name is intentionally omitted from my review. 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).

MADRID – Using allopurinol to reduce hyperuricemia in young adults with prehypertension or stage 1 hypertension failed to significantly lower blood pressure but succeeded in significantly improving endothelial function as measured by increased flow-mediated arterial dilation in a single-center crossover study with 82 participants.

The finding of improved endothelial function suggests that reducing hyperuricemia may be a new way to manage hypertension or prevent progression to stage 1 hypertension, improve cardiovascular health, and ultimately cut cardiovascular events, Angelo L. Gaffo, MD, said at the European Congress of Rheumatology. The results indicated that the BP-lowering effect of allopurinol treatment was strongest in people who entered the study with the highest serum urate levels, greater than 6.5 mg/dL, an indication that the next step in developing this approach should be targeting it to people with serum urate levels in this range, said Dr. Gaffo, a rheumatologist at the University of Alabama at Birmingham.

“It’s just a matter of finding the right population to see the blood pressure reduction effect,” Dr. Gaffo said in an interview.

He and his associates designed the SURPHER (Serum Urate Reduction to Prevent Hypertension) study to assess the impact of allopurinol treatment in people aged 18-40 years with prehypertension or stage 1 hypertension as defined by U.S. BP standards at the time they launched the study in 2016 (Contemp Clin Trials. 2016 Sep;50:238-44). Enrolled participants had to be nonsmokers; have an estimated glomerular filtration rate of greater than 60 mL/min per 1.73 m²; have a serum urate level of at least 5.0 mg/dL in men and at least 4.0 mg/dL in women; and be without diabetes, antihypertensive medications, prior urate-lowering treatment, or a history of gout. The 99 people who started the study averaged 28 years old, nearly two-thirds were men, 40% were African Americans, and 52% were white. The participants’ average body mass index was nearly 31 kg/m², and their average BP was 127/81 mm Hg. Average serum urate levels were 6.4 mg/dL in men and 4.9 mg/dL in women. Participants received 300 mg/day allopurinol or placebo, and after 4 weeks crossed to the alternate regimen, with 82 people completing the full protocol. While on allopurinol, serum urate levels fell by an average of 1.3 mg/dL, a statistically significant drop; on placebo, the levels showed no significant change from baseline.

The primary endpoint was the change in BP on allopurinol treatment, which overall showed no statistically significant difference, compared with when participants received placebo. The results also showed no significant impact of allopurinol treatment, compared with placebo, in serum levels of high-sensitivity C-reactive protein, a measure of inflammation. However, for the secondary endpoint of change in endothelial function as measured by a change in flow-mediated dilation (FMD), the results showed a statistically significant effect of allopurinol treatment. While on allopurinol, average FMD increased from 10.3% at baseline to 14.5% on the drug, a 41% relative increase, while on placebo the average FMD rate showed a slight reduction. Allopurinol treatment was safe and well tolerated during the study.

The results also showed that among people with a baseline serum urate level of greater than 6.5 mg/dL (15 of the 82 study completers) systolic BP fell by an average of about 5 mm Hg.

The results suggested that the concept of reducing hyperuricemia in people with early-stage hypertension or prehypertension might be viable for people with higher serum urate levels than most of those enrolled in SURPHER, Dr. Gaffo said. He noted that prior study results in obese adolescents showed that treating hyperuricemia was able to produce a meaningful BP reduction (Hypertension. 2012 Nov;60[5]:1148-56).

SURPHER received no commercial funding. Dr. Gaffo has received research funding from Amgen and AstraZeneca.

[email protected]

MADRID – Using allopurinol to reduce hyperuricemia in young adults with prehypertension or stage 1 hypertension failed to significantly lower blood pressure but succeeded in significantly improving endothelial function as measured by increased flow-mediated arterial dilation in a single-center crossover study with 82 participants.

The finding of improved endothelial function suggests that reducing hyperuricemia may be a new way to manage hypertension or prevent progression to stage 1 hypertension, improve cardiovascular health, and ultimately cut cardiovascular events, Angelo L. Gaffo, MD, said at the European Congress of Rheumatology. The results indicated that the BP-lowering effect of allopurinol treatment was strongest in people who entered the study with the highest serum urate levels, greater than 6.5 mg/dL, an indication that the next step in developing this approach should be targeting it to people with serum urate levels in this range, said Dr. Gaffo, a rheumatologist at the University of Alabama at Birmingham.

“It’s just a matter of finding the right population to see the blood pressure reduction effect,” Dr. Gaffo said in an interview.

He and his associates designed the SURPHER (Serum Urate Reduction to Prevent Hypertension) study to assess the impact of allopurinol treatment in people aged 18-40 years with prehypertension or stage 1 hypertension as defined by U.S. BP standards at the time they launched the study in 2016 (Contemp Clin Trials. 2016 Sep;50:238-44). Enrolled participants had to be nonsmokers; have an estimated glomerular filtration rate of greater than 60 mL/min per 1.73 m²; have a serum urate level of at least 5.0 mg/dL in men and at least 4.0 mg/dL in women; and be without diabetes, antihypertensive medications, prior urate-lowering treatment, or a history of gout. The 99 people who started the study averaged 28 years old, nearly two-thirds were men, 40% were African Americans, and 52% were white. The participants’ average body mass index was nearly 31 kg/m², and their average BP was 127/81 mm Hg. Average serum urate levels were 6.4 mg/dL in men and 4.9 mg/dL in women. Participants received 300 mg/day allopurinol or placebo, and after 4 weeks crossed to the alternate regimen, with 82 people completing the full protocol. While on allopurinol, serum urate levels fell by an average of 1.3 mg/dL, a statistically significant drop; on placebo, the levels showed no significant change from baseline.

The primary endpoint was the change in BP on allopurinol treatment, which overall showed no statistically significant difference, compared with when participants received placebo. The results also showed no significant impact of allopurinol treatment, compared with placebo, in serum levels of high-sensitivity C-reactive protein, a measure of inflammation. However, for the secondary endpoint of change in endothelial function as measured by a change in flow-mediated dilation (FMD), the results showed a statistically significant effect of allopurinol treatment. While on allopurinol, average FMD increased from 10.3% at baseline to 14.5% on the drug, a 41% relative increase, while on placebo the average FMD rate showed a slight reduction. Allopurinol treatment was safe and well tolerated during the study.

The results also showed that among people with a baseline serum urate level of greater than 6.5 mg/dL (15 of the 82 study completers) systolic BP fell by an average of about 5 mm Hg.

The results suggested that the concept of reducing hyperuricemia in people with early-stage hypertension or prehypertension might be viable for people with higher serum urate levels than most of those enrolled in SURPHER, Dr. Gaffo said. He noted that prior study results in obese adolescents showed that treating hyperuricemia was able to produce a meaningful BP reduction (Hypertension. 2012 Nov;60[5]:1148-56).

SURPHER received no commercial funding. Dr. Gaffo has received research funding from Amgen and AstraZeneca.

[email protected]

MADRID – Using allopurinol to reduce hyperuricemia in young adults with prehypertension or stage 1 hypertension failed to significantly lower blood pressure but succeeded in significantly improving endothelial function as measured by increased flow-mediated arterial dilation in a single-center crossover study with 82 participants.

The finding of improved endothelial function suggests that reducing hyperuricemia may be a new way to manage hypertension or prevent progression to stage 1 hypertension, improve cardiovascular health, and ultimately cut cardiovascular events, Angelo L. Gaffo, MD, said at the European Congress of Rheumatology. The results indicated that the BP-lowering effect of allopurinol treatment was strongest in people who entered the study with the highest serum urate levels, greater than 6.5 mg/dL, an indication that the next step in developing this approach should be targeting it to people with serum urate levels in this range, said Dr. Gaffo, a rheumatologist at the University of Alabama at Birmingham.

“It’s just a matter of finding the right population to see the blood pressure reduction effect,” Dr. Gaffo said in an interview.

He and his associates designed the SURPHER (Serum Urate Reduction to Prevent Hypertension) study to assess the impact of allopurinol treatment in people aged 18-40 years with prehypertension or stage 1 hypertension as defined by U.S. BP standards at the time they launched the study in 2016 (Contemp Clin Trials. 2016 Sep;50:238-44). Enrolled participants had to be nonsmokers; have an estimated glomerular filtration rate of greater than 60 mL/min per 1.73 m²; have a serum urate level of at least 5.0 mg/dL in men and at least 4.0 mg/dL in women; and be without diabetes, antihypertensive medications, prior urate-lowering treatment, or a history of gout. The 99 people who started the study averaged 28 years old, nearly two-thirds were men, 40% were African Americans, and 52% were white. The participants’ average body mass index was nearly 31 kg/m², and their average BP was 127/81 mm Hg. Average serum urate levels were 6.4 mg/dL in men and 4.9 mg/dL in women. Participants received 300 mg/day allopurinol or placebo, and after 4 weeks crossed to the alternate regimen, with 82 people completing the full protocol. While on allopurinol, serum urate levels fell by an average of 1.3 mg/dL, a statistically significant drop; on placebo, the levels showed no significant change from baseline.

The primary endpoint was the change in BP on allopurinol treatment, which overall showed no statistically significant difference, compared with when participants received placebo. The results also showed no significant impact of allopurinol treatment, compared with placebo, in serum levels of high-sensitivity C-reactive protein, a measure of inflammation. However, for the secondary endpoint of change in endothelial function as measured by a change in flow-mediated dilation (FMD), the results showed a statistically significant effect of allopurinol treatment. While on allopurinol, average FMD increased from 10.3% at baseline to 14.5% on the drug, a 41% relative increase, while on placebo the average FMD rate showed a slight reduction. Allopurinol treatment was safe and well tolerated during the study.

The results also showed that among people with a baseline serum urate level of greater than 6.5 mg/dL (15 of the 82 study completers) systolic BP fell by an average of about 5 mm Hg.

The results suggested that the concept of reducing hyperuricemia in people with early-stage hypertension or prehypertension might be viable for people with higher serum urate levels than most of those enrolled in SURPHER, Dr. Gaffo said. He noted that prior study results in obese adolescents showed that treating hyperuricemia was able to produce a meaningful BP reduction (Hypertension. 2012 Nov;60[5]:1148-56).

SURPHER received no commercial funding. Dr. Gaffo has received research funding from Amgen and AstraZeneca.

[email protected]

The Food and Drug Administration has announced that Teva is expanding its recall to certain lots of losartan potassium distributed by Golden State Medical Supply, according to a release.

The recall for this and other angiotensin II receptor blockers was initiated by Teva on April 25, 2019, because of detection of unacceptable levels of the possibly cancer-causing impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Teva expanded this recall on June 10, with another update issued on June 12.


Losartan is not the only ARB found to contain NMBA; a full list of all ARBs affected can be found on the FDA website and currently includes more than 1,100 lots being recalled. The list can be searched and sorted by such considerations as medicine in question, company involved, and lot number.

[email protected]

The Food and Drug Administration has announced that Teva is expanding its recall to certain lots of losartan potassium distributed by Golden State Medical Supply, according to a release.

The recall for this and other angiotensin II receptor blockers was initiated by Teva on April 25, 2019, because of detection of unacceptable levels of the possibly cancer-causing impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Teva expanded this recall on June 10, with another update issued on June 12.


Losartan is not the only ARB found to contain NMBA; a full list of all ARBs affected can be found on the FDA website and currently includes more than 1,100 lots being recalled. The list can be searched and sorted by such considerations as medicine in question, company involved, and lot number.

[email protected]

The Food and Drug Administration has announced that Teva is expanding its recall to certain lots of losartan potassium distributed by Golden State Medical Supply, according to a release.

The recall for this and other angiotensin II receptor blockers was initiated by Teva on April 25, 2019, because of detection of unacceptable levels of the possibly cancer-causing impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). Teva expanded this recall on June 10, with another update issued on June 12.


Losartan is not the only ARB found to contain NMBA; a full list of all ARBs affected can be found on the FDA website and currently includes more than 1,100 lots being recalled. The list can be searched and sorted by such considerations as medicine in question, company involved, and lot number.

[email protected]

MADRID – An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

MADRID – An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

MADRID – An observational study that includes adults and children with cryopyrin-associated periodic syndromes and related diseases has provided real-world evidence that clinical improvement accrues on canakinumab (Ilaris) years after treatment was initiated, according to Norbert Blank, MD, of the division of rheumatology at the University of Heidelberg (Germany).

Summarizing data he presented at the European Congress of Rheumatology, Dr. Blank explained in an interview that the observational study has accrued more than 50 patients so far, with the goal of reaching 300 patients with cryopyrin-associated periodic syndromes and related rare diseases that have responded to anti–interleukin-1 therapy, such as Muckle-Wells syndrome, familial cold autoinflammatory syndrome, and familial Mediterranean fever.

Most of the patients participating in the observational study, called RELIANCE, were already on canakinumab at the time of enrollment, often for several years. Yet in follow-up so far – which exceeds 1 year for some of the participants – improvement from the time of entry has been seen for some outcomes, such as activity level, according to Dr. Blank.

Canakinumab has been well tolerated with no new or unexpected adverse events emerging in the follow-up so far. Although these data remain limited, Dr. Blank considers them reassuring.

With detailed characterization of these rare diseases at baseline, observational studies like RELIANCE provide valuable real-world data about disease presentation, according to Dr. Blank. He believes that further follow-up will provide a rich source of information about disease course in response to anti-IL-1 therapy, which is being individualized according to response.

The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.

Olivier Le Moal/Getty Images

This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.

Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.

In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.

Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.

Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.

The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

[email protected]

The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.

Olivier Le Moal/Getty Images

This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.

Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.

In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.

Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.

Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.

The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

[email protected]

The Food and Drug Administration has approved Amgen’s trastuzumab-anns as a trastuzumab biosimilar for the treatment of HER2-positive breast cancer and gastric cancer.

Olivier Le Moal/Getty Images

This biosimilar, to be marketed as Kanjinti, is the fifth trastuzumab biosimilar to be approved by the agency, according to the FDA.

Approval was based in part on the LILAC study, which demonstrated that the biosimilar, previously called ABP-980, had similar efficacy and comparable cardiac safety with trastuzumab.

In the phase 3 study, 725 patients with HER2-positive early breast cancer were randomized to neoadjuvant treatment with trastuzumab-anns or trastuzumab, plus paclitaxel, for four cycles following four cycles of chemotherapy. The primary pathological complete response endpoint was achieved in 48% of those in the biosimilar arm, compared with 40.5% in the trastuzumab arm. Patients then went on to receive adjuvant treatment with ABP 980 or trastuzumab every 3 weeks for up to 1 year following surgery.

Grade 3 or worse adverse events during the neoadjuvant phase occurred in 15% of patients in the ABP 980 group and 14% in the trastuzumab group. The most frequent grade 3 event in both study arms was neutropenia. In the adjuvant phase, grade 3 or worse adverse events occurred in 9% of those continuing ABP 980 and in 6% of those continuing trastuzumab. The most frequent events in both arms were infections, infestations, and neutropenia.

Trastuzumab-anns is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative breast cancer, first-line treatment of HER2-overexpressing metastatic breast cancer, and first-line treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The FDA indicates patients should be selected based on an FDA-approved companion diagnostic for a trastuzumab product.

The biosimilar includes a boxed warning for cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

[email protected]