Enhancing Patient Engagement Efforts Across the FDA

 
The FDA is soliciting input on ongoing efforts to enhance mechanisms for patient engagement at the Agency. In this tradition, FDA intends to enhance future patient engagement by providing a more transparent, accessible, and robust experience for patient communities. To achieve these goals, FDA is considering establishing a new Office of Patient Affairs. This concept was directly informed by the public feedback solicited through the prior public docket regarding FDA’s stakeholder engagement responsibilities outlined by the FDA Safety and Innovation Act. The purpose of this notice is to outline FDA’s proposal for the future of patient engagement at the Agency so that the perspectives of patient communities can be better captured. Comments on this proposal are accepted through June 12, 2017.
To read more, please click here.

Assisted Outpatient Treatment in New York State: The Case for Making Kendra’s Law Permanent

Assisted outpatient treatment (AOT) is a procedure by which seriously mentally ill individuals are placed under a court-ordered treatment plan while continuing to live in the community. New York State’s version of AOT is known as “Kendra’s Law,” named after Kendra Webdale, a New York City resident pushed to her death in front of a subway train in 1999 by a man with untreated schizophrenia.
Kendra’s Law was enacted on a trial basis and has been temporarily reauthorized twice. It is up for reauthorization again during the current legislation session. Based on experience and extensive research, the state government should make the law permanent.
To read the report, please click here.

How this couple stopped mental illness from tearing them apart

San Francisco-based teacher Mark Lukach was married to his wife Giulia for just three years when she had her first psychotic episode at age 27. In the years that followed, he and Giulia and their young son, Jonas, learned how to cope with the terrifying psychosis, the crippling depression, recovery and relapses that came along with Giulia’s late-onset bipolar disorder. In his memoir, “My Lovely Wife in the Psych Ward” (Harper Wave, May 2), Lukach, 34, chronicles his journey as caregiver, father and husband as he and Giulia, also 34, worked together to manage her illness. Here, Lukach tells The Post’s Lauren Steussy about their life together.

 

To read the article, please click here to visit New York Post.

You Need To Be Watching What Is Happening In Washington: A Big Shift Maybe Coming

Texas Senator John Cornyn, the Republican majority whip in the Senate, is putting federal dollars behind his  Mental Health and Safe Communities Act, that was signed into law during the final days of the Obama administration.

Because of the hoopla about Pennsylvania Republican Rep. Tim Murphy’s Helping Families in Mental Health Crisis Act, Cornyn’s legislation didn’t get as much attention as it deserved.

Getting a law passed and funding it can be two separate challenges.

Cornyn just got $2.5 million set-aside for supporting a dozen national Crisis Intervention Team training centers to help better prepare law enforcement officers for dealing with individuals in a mental health crisis.

To read more, please click here.

ICYMI: Murphy on C-SPAN: Continuing the Fight for Families in Mental Health Crisis

On March 22, 2017, Congressman Murphy continued his fight for families in mental health crisis on C-SPAN’s Washington Journal. In case you missed it, check out the highlights and watch the full interview below.

 

Estrogen Alters Memory Circuit Function in Women with Gene Variant

Hormone-gene interaction may underlie sex/individual differences in mental disorders

Fluctuations in estrogen can trigger atypical functioning in a key brain memory circuit in women with a common version of a gene, NIMH scientists have discovered. Brain scans revealed altered circuit activity linked to changes in the sex hormone in women with the gene variant while they performed a working memory task. The findings may help to explain individual differences in menstrual cycle and reproductive-related mental disorders linked to fluctuations in the hormone. They may also shed light on mechanisms underlying sex-related differences in onset, severity, and course of mood and anxiety disorders and schizophrenia. The gene-by-hormone interaction’s effect on circuit function was found only with one of two versions of the gene that occurs in about a fourth of white women. Drs. Karen Berman, Peter Schmidt, Shau-Ming Wei, and colleagues, of the NIMH Intramural Research Program, report on this first such demonstration in women April 18, 2017 in the journal Molecular Psychiatry.

To know more, please click here.

 

Multipronged Study of Schizophrenia associated Syndrome Receives $3.1 Million NIH Grant

A research team at Emory University is embarking on a multipronged study of 3q29 deletion syndrome, a genetic mutation associated with a 40-fold increased risk for schizophrenia and a range of other neuropsychiatric conditions including mild to moderate intellectual disability, autism and anxiety. The research is funded by a $3.1 million grant from the National Institute of Mental Health of the National Institutes of Health.

The researchers will produce the first neuronal model of the schizophrenia-associated syndrome, which results from the deletion of a region of 22 genes. By uncovering the specific biological processes disrupted by the mutation, they hope to provide a molecular window into the key developmental processes relevant to schizophrenia and other neuropsychiatric conditions. They also will integrate their research with other targets identified in genetic studies of schizophrenia, autism, and intellectual disability, potentially leading to new ways to treat affected patients.

To read more, please click here.

Adjunctive VNS Improves Long-Term Outcomes in Treatment-Resistant Depression

Adjunctive vagus nerve stimulation (VNS) can lead to better five-year clinical outcomes in patients with chronic, treatment-resistant depression, reports a study published March 31 inAJP in Advance.

These findings provide the first long-term evidence of the benefits of VNS.

VNS, which involves delivering electrical impulses to the vagus nerve via an implanted generator, was approved for treatment-resistant depression in 2005. As part of the approval, the Food and Drug Administration required a postmarketing surveillance study, which led to the formation of the Treatment-Resistant Depression Registry. The registry is an observational program carried out at 61 sites across the United States that has monitored a large cohort of patients with treatment-resistant depression for five years each.

There were 795 study participants. Treatment resistance was defined as ongoing unipolar or bipolar depression that lasted at least two years or recurred at least three times and failure on four or more depression treatments, including maintenance pharmacotherapy, psychotherapy, and ECT. Within the group, 494 patients received periodic VNS over five years in addition to usual treatments, and 301 received usual-treatment only.

To read more, please click here.

Intellectual Disability Still a Bar to Death Penalty, Says Supreme Court

The U.S. Supreme Court on March 28 reaffirmed that intellectual disability is a constitutional barrier to the death penalty. The ruling in the case of Moore v. Texas upheld two previous decisions.

APA had signed onto an amicus brief last year in support of Moore with the American Academy of Psychiatry and the Law, American Psychological Association, National Association of Social Workers, and National Association of Social Workers Texas Chapter.

“The Court, consistent with APA’s position, sent the case of Bobby Moore back to a lower court after finding that Texas failed to apply contemporary medical standards for making the diagnosis of intellectual disability,” Marvin Swartz, M.D., told Psychiatric News. Swartz is chair of APA’s Committee on Judicial Action and a professor of psychiatry and behavioral sciences at Duke University School of Medicine.

To read more, please click here.

Multipronged study of schizophrenia-associated syndrome receives $3.1 million NIH grant

A research team at Emory University is embarking on a multipronged study of 3q29 deletion syndrome, a genetic mutation associated with a 40-fold increased risk for schizophrenia and a range of other neuropsychiatric conditions including mild to moderate intellectual disability, autism and anxiety. The research is funded by a $3.1 million grant from the National Institute of Mental Health of the National Institutes of Health.

The researchers will produce the first neuronal model of the schizophrenia-associated syndrome, which results from the deletion of a region of 22 genes. By uncovering the specific biological processes disrupted by the mutation, they hope to provide a molecular window into the key developmental processes relevant to schizophrenia and other neuropsychiatric conditions. They also will integrate their research with other targets identified in genetic studies of schizophrenia, autism, and intellectual disability, potentially leading to new ways to treat affected patients.

Co-principal investigators for the project at Emory University School of Medicine are Jennifer Mulle, PhD, assistant professor of human genetics and Gary Basell, PhD, professor and chair of cell biology. Other project collaborators are in the Emory Department of Psychiatry and Behavioral Sciences, Emory Department of Pediatrics, Emory Department of Psychology, and the Marcus Autism Center.

To read more, please click here.