I have been credentialed for virtual BIO 2020

I have been credentialed to attend the annual BIO meeting as press. 

This year, BIO will be a virtual conference, taking place from June 8-12.

I covered BIO last year for the journal P&T. Clips available upon request.

I am happy to entertain any requests for coverage.

Midwest Business Group on Health Rescheduled for September

The annual meeting of the Midwest Business Group on Health has been rescheduled for Sept. 3-4 in Chicago.

I am registered, and happy to take any assignments.

Some cancellations

The AACR preconference presscast was canceled, and the annual meeting was terminated. Digestive Disease Week was also canceled

The AACR Pre-Conference Webcast is March 24

I will be virtually attending the March 24 pre-conference presscast for the annual AACR meeting.

I am also registered for the AACR's annual meeting in San Diego. I have made travel arrangements, and I can attend and cover the conference for you.

The pre-conference event will include discussions of research on statin treatment in subgroups of ovarian cancer patients, 

a real world assessment of immunotherapy in stage III melanoma, and the predictive value of precision medicine in young cancer patients.

Also, the following day, the embargo will lift on "AACR Cancer Disparities Progress Report 2020: Achieving the Bold Vision of Health Equity for Racial and Ethnic Minorities and Other Underserved Populations."

Please contact me to arrange for coverage.

Coverage from AACR and DDW

I have received press credentials to attend the American Association for Cancer Research in San Diego and Digestive Disease Week in Chicago as press. I have already made travel arrangements, so I won't need to charge you for any expenses.

If you are interested in coverage from these conferences, please contact me via the email address in the sidebar.

April

American Association for Cancer Research

April 24-29, San Diego

https://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=213

May

Digestive Disease Week

May 2-5, Chicago

http://ddw-2020.org/

Live Coverage from AACAP 2019

My extensive coverage from AACAP 2019 in Chicago has been published by P&T.

(AACAP stands for the American Academy of Child and Adolescent Psychiatry, while P&T stands for Pharmacy and Therapeutics).

AACAP is always a fascinating opportunity for me to learn about psychiatry in children, as well as pediatric use of medicines, so what follows are several extra AACAP 2019 stories.


Statistics: No Difference in Fracture Rate Among Girl and Boy Initiators of Benzodiazepines and SSRIs


                A poster comparing the risk for fracture in young anxiety disorder patients treated with benzodiazepines compared with SSRIs did not find a statistically significant difference stratified by sex, according to Greta Bushnell, PhD, postdoctoral fellow in the department of epidemiology at Columbia University Mailman School of Public Health, in New York City.

“We did see an elevated fracture rate in boys compared to girls, which is consistent with the literature,” added Bushnell, lead author on poster 5.11, “Benzodiazepine treatment and fracture risk: Gender differences in children with anxiety disorders.” 

Generally speaking, studies sometimes show greater fracture risk in girls than boys, but in this study, among benzodiazepine initiators, boys had 45 limb fracture rates per thousand patient years, compared to 26 among girls. Among SSRI initiators; the rates were 33 among boys and 20 among girls. 

The study was an analysis of the MarketScan Commercial Claims Database from 2007 to 2016, yielding information on 46085 boys and 74,630 girls according to the poster. 

“Benzodiazepines are recommended for short-term treatment and, in our data, we see that the majority of children only have one benzodiazepine prescription fill before treatment discontinuation,” said Bushnell.

“The few randomized controlled trials of benzodiazepines conducted in children with anxiety disorders have not shown efficacy, whereas SSRIs have shown efficacy for anxiety disorders in children. The lack of efficacy coupled with safety concerns, such as dependency, lead most recommendations to call for SSRIs over BZD for children with anxiety disorders,” she added.

However, the poster indicated that the adjusted upper-and-lower limb fracture rate for boys was 13.5%, compared with 6.5% among girls. The rate for boys of any fracture was 14%, compared with 5.2% among girls.

“The effect estimates suggest an increased risk of fractures in boys and girls initiating benzodiazepine treatment compared to SSRI treatment, with a slightly higher rate difference in boys. It will be important to see if similar results are observed in future work,” said Bushnell.

Poster Reviews 35 publications Studying SSRIs for Anxiety, a Chronic Pediatric Condition

A poster at AACAP reviewed 35 publications, and discussed eight treatment regimens for anxiety disorders in children. 

“Anti- Anxiety related response of antidepressant is apparent in the first 2 weeks with more significant difference evident by 6 weeks of treatment. Appropriate recommended duration of treatment of pediatric anxiety disorder is about 6-9 months,” concluded Poster 5.17, “Pediatric Anxiety Disorders (PAD) and pharmacologic intervention: Which medication to pick?” (Memon et al).

Untreated anxiety disorders are associated with serious comorbidities such as mood instability, substance use, and suicidal ideation and attempts. 

“For mild-to-moderate anxiety, maybe you can start with only therapy,” said Sadiq Naveed, MD, assistant professor of psychiatry at the University of Kansas Medical Center, in Overland Park, Kansas, an author on the poster.

However, anxiety is a chronic condition with a lifetime prevalence of around 25 to 32%.

The study was published in a review article this month in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP).

The study was not a meta-analysis, but more of a descriptive study, emphasized Naveed.

The poster described the prevalence of several disorders of the anxiety class, including: social anxiety disorder (9.1%); specific phobias (19.3%), such as thunderstorms, injection, or the sight of blood; and panic disorder (2.3%), for example.

The poster also discussed a study of the ADHA psycho-stimulant methylphenidate used in patients with anxiety disorders and ADHD.

“The study did not combine the effects of different studies, and say whether a medication is better than another one,” said Naveed.

However, one of the studies described in Naveed’s poster found that 80% of patients did report a response to cognitive behavioral therapy and sertraline, compared to 59% of the patients treated with only cognitive therapy and 54.9% with only sertraline, for example.

“The best are the SSRIs,” Naveed concluded.

“In our review article, we didn’t come across any studies looking at anti-psychotic medication for anxiety disorders,” he noted.

However, the poster doesn’t describe all of the studies; the 35 studies are discussed in two companion articles [one of them a draft], he added.

Alpha2 Agonists Said to be of Little Benefit in Institutionalized Patients with Intellectual Impairment


                Use of clonidine was associated with a greater rate of seclusion when used to treat children and adolescents in a psychiatric inpatient setting, according to a retrospective study of patient charts presented at AACAP 2019.


                Administration of alpha2 agonists clonidine and guanfacine was not related to length-of-stay among institutionalized children (including a subset with intellectual impairment), and otherwise was of uncertain benefit.

“For intellectually impaired children and adolescents, treatment with Clonidine and Guanfacine during psychiatric inpatient stay may be of little benefit,” concluded Poster 3.40, “Clonidine Versus Guanfacine in Intellectual Disability:  Tangible Outcomes in the South Bronx Child and Adolescent  Psychiatric Inpatient Setting.”

Patients with intellectual disability tend to have elevated rates of psychiatric comorbidities and increased aggression, the poster said.

“I’d heard that clonidine doesn’t work in autism spectrum disorder patients, but that guanfacine does. In the in-patient setting, alpha2 agonists may be of little benefit in kids with IQs below 80,” said Robert Dugger, MD, a psychiatry resident at the Icahn School of Medicine in New York City. “We were expecting to see a significant difference, but didn’t,” summarized Dugger, lead author on the poster.

In the study, researchers reviewed the charts of 156 patients aged 6 through 17 (with a mean age of 13.4). The patients’ IQs were evaluated between December 3, 2012 and April 3, 2017 at the BronxCare Health System in New York. Of the patients, 54.5% were Hispanic, 37.2% African American, and 0.6% Caucasian, according to the poster.

Most of the patients (102) received no alpha2 agonist, 36 received clonidine, and 18 received guanfacine.

Patients treated with clonidine were secluded more times on average (p<.001). “When we controlled for length of stay, this dropped to insignificance,” explained Dugger.

The patient population was highly comorbid, according to the poster: at discharge, 32.7% of the patients were diagnosed with depression, dipolar disorder, or mood disorders; 19.9% with a schizoaffective condition or psychosis; and 12.2% with ADHD, among other comorbidities.

“Our findings are not necessarily representative of the rest of the country; about 99.9% of our patients were covered by Medicare / Medicaid,” cautioned Dugger, noting that the institution’s formulary does not include long-acting guanfacine.

The only variable to significantly predict length of stay was age, with older patients having reduced length of stay (p=.007), the study concluded.

The Return of Viloxazine?

Three posters at AACAP described three ADHD phase III clinical trials of a new, extended-release version of an old anti-depressant, Viloxazine, which was pulled from the European market voluntarily in its original formulation, and never licensed in the US.

According to the posters, 1.70 and 1.72, a dose of 200 milligrams per day in children between six and 11 was associated with statistically significant improvements as much as 400 milligrams. (Poster 1.70 was called “A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (P301) Assessing the Efficacy and Safety of SPN-812  (Extended-Release Viloxazine) 100 and 200 mg for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children”; Poster 1.72 was called “A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (P303) Assessing the Efficacy and Safety of SPN-812  (Extended-Release Viloxazine) 200 and 400 mg for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Azmi Nasser, PhD1.”

Poster 1.71 presented the results of a phase III trial in adolescents, in which the new formulation showed efficacy in the patients’ Clinical Global Impression-Improvement (CGI) score, but not other measures. (“A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (P302) Assessing the Efficacy and Safety of SPN-812  (Extended-Release Viloxazine) 200 and 400 mg for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Adolescents”).

“You’ve got to look at how many patients discontinued,” said an individual associated with Supernus Pharmaceuticals, who presented the poster. 

Across the three posters, discontinuation due to adverse events varied among the patient populations and dosage, from 1.2% to 5.6%.

There are currently insufficient options for patients with ADHD, according to a spokesperson for the company. “The stimulants, while highly effective, have a side effect profile that makes it difficult or even impossible for some patients to use them,” noted Peter Vozzo, managing director of Supernus’ outside investor relations firm.

However, a phase II trial of the new formulation showed a high rate of discontinuations (27.9%, including discontinuations not due to adverse events), according to a recent article in the Journal of Attention Disorders ("A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD,” Johnson, et al).

While the original formulation of viloxazine was approved in Europe for depression, it was voluntarily withdrawn for unknown reasons, according to corporate spokespersons. Apparently, it was never submitted in the US.

More recently, however, the FDA has approved two phase II trials and four phase III trials, and the company plans to submit a new drug application to the FDA in 2019, Vozzo said.

My article related to business ethics has been published by Leader's Edge Magazine

Leader's Edge Magazine (published by the Council of Insurance Agents and Brokers), has published my work.

https://www.leadersedge.com/p-c/pivot-point

 

"Can the insurance industry be a force for prevention in the pandemic of child sex abuse?"
Leader's Edge, Sept., 2019