SAMHSA Administrator Pamela Hyde begins with facts about suicide and discusses prevention, the National Action Alliance for Suicide Prevention, and the crisis of untreated substance abuse and mental health disorders. This presentation also explores the need for a national dialogue on the role of behavioral health in public life.
The Substance Abuse and Mental Health Services Administration (SAMHSA) awarded $6.2 million in grants to 21 colleges and universities to assist in their efforts to prevent suicide and enhance mental health services for students in crisis. The grants are designed to enhance services for students with behavioral health problems, such as depression and substance abuse, which may put them at risk for suicide and suicide attempts.
As part of Suicide Prevention Awareness, NIMH is sponsoring a videocast panel of suicide prevention experts. This is a great opportunity to ask questions and hear directly from people working in the field.
When: September 7, 2011 from 2:00 to 3:30 PM EDT
Where: National Institute of Mental Health
6001 Executive Boulevard Rockville, Maryland 20852
This event will be videocast. Those who live in the area are welcome to join us as part of the live audience. Seating is limited.
Allon Therapeutics Inc. announced new findings that 12 weeks of treatment with the Company’s lead product davunetide appears to prevent cortical thinning of important parts of the brains of schizophrenia patients.
Dr. Bruce Morimoto, Allon’s Vice-President of Drug Development, said “the new data are consistent with the neuroprotective effect we have seen with davunetide including our other human trials and provide further confirmation of the strategy behind our ongoing Phase 2/3 pivotal study in progressive supranuclear palsy.”
Dr. Morimoto said the new data emerged from the ongoing analysis of magnetic resonance imaging (MRI) data by a group of scientists and physicians led by Dr. Jeffrey Lieberman, Chairman of the Department of Psychiatry at Columbia University School of Physicians and Surgeons, and Director of the New York Psychiatric Institute.
“The new data showed that in the 23 patient study the thickness of the cortex in specific regions of the brain decreased in the eight schizophrenia patients given placebo, whereas it did not change in the 15 patients treated with davunetide.” The cortex is tissue in the human brain made up of neuronal cell bodies. “While these data come from a small exploratory study, they suggest that davunetide treatment prevents the cortical thinning observed in schizophrenia”, Morimoto added….
WASHINGTON August 10, 2011, 11:44 am ET
Johnson & Johnson has tentatively agreed to settle a single misdemeanor criminal charge related to a multi-year government investigation into the marketing of its psychiatric drug Risperdal.
The company said Monday in a regulatory filing that the agreement related to an allegation that the company promoted Risperdal for unapproved uses. The agreement, which has not been finalized, was disclosed in a filing with the Securities and Exchange Commission.
J&J said it has set aside funds to pay the proposed settlement fee, but did not disclose the amount.
The Justice Department and the U.S. attorney’s office in Philadelphia are still pursuing other criminal and civil actions against the company, according to the filing.
Since 2004, J&J’s Janssen Pharmaceuticals unit has received numerous subpoenas over Risperdal from federal and state prosecutors. Attorneys general from 11 states are seeking penalties from J&J, which is based in New Brunswick, N.J.
J&J said the government plans to join civil lawsuits filed by company whistleblowers who allege off-label marketing of Risperdal and a related drug Invega. When federal prosecutors join such cases it usually signals that the government believes it may be able to recover millions of dollars paid for prescriptions for patients in government health programs like Medicare and Medicaid. Risperdal and Invega are both used to treat schizophrenia and other psychiatric disorders.
The company said it is unclear whether the civil suits can be settled due to various factors, including “significant facts in dispute … and numerous parties involved.”
Marketing drugs for off-label, or unapproved uses, is illegal, though common in the pharmaceutical industry. In recent years the Justice Department has pursued allegations of off-label marketing against virtually every major pharmaceutical company.
The government probe started with a 2004 federal subpoena demanding documents, covering the years 1997 through 2002, on J&J’s sales practices, payments to physicians related to marketing of Risperdal and clinical trials conducted on the drug. That subpoena came from the Office of the Inspector General of the U.S. Office of Personnel Management.
In 2005, the U.S. Attorney’s Office in Philadelphia also subpoenaed J&J, asking for information on the marketing of and adverse reactions to Risperdal, which brought in more than $3 billion in annual sales before losing patent protection and going generic about three years ago.
Attorneys general in 11 states are also seeking penalties from J&J for alleged off-label marketing of Risperdal, overpayment by state health programs and side effects to patients.
In October 2010, a Louisiana jury ruled that J&J had illegally marketed Risperdal and should pay $258 million in damages to the state. J&J said Monday it is appealing the decision.
In June a South Carolina judge levied a $327 million fine against the drugmaker for deceptive marketing of Risperdal. J&J says it will seek relief from the penalty or appeal the case.
Johnson & Johnson shares fell $1.66, or 2.7 percent, to $60.54 in midday trading Wednesday.
by The Associated Press
There has been so much concern in the mental health community about cutbacks in services and potential changes in funding, it’s easy to overlook an important, positive change in policy. Earlier this month, the White House announced that henceforth, soldiers who die by suicide while deployed in a war zone will be recognized just as others who die in service to this country. In an extraordinary statement, the President noted, “They didn’t die because they were weak.”
This statement was followed by a White House Blog post from the Army Vice Chief of Staff General Peter Chiarelli, who stated, “Many are struggling with the ‘invisible wounds’ of this war, including traumatic brain injury, post-traumatic stress, depression and anxiety. Any attempt to characterize these individuals as somehow weaker than others is simply misguided.”
Why this change in our approach to soldier suicides? Partly, this reflects recognition of the increasing rates of suicide in the military, rates that have doubled for the Army since 2004. While soldiers traditionally have lower rates of suicide relative to age and gender-matched civilians, the rates in the Army began exceeding civilian rates in 2008. Since 2010, more soldiers have died from suicide than in combat.
What is driving this increase in suicide? An NIMH-Army collaboration, the Army Study to Assess Risk and Resilience in Soldiers (Army STARRS), has been reviewing recent suicides, as well as mounting a prospective study of new and active duty soldiers, to answer this question. The results from reviewing 389 suicide deaths defy any simple or single explanation. There has been an understandable tendency to attribute the increasing rate to the rigors of a continuing war, with many soldiers experiencing multiple deployments and many affected by post traumatic stress disorder and traumatic brain injury. The risk for suicide has risen for all soldiers, regardless of whether they have been deployed, but the data show that a soldier’s risk for suicide is greatest while deployed. Army STARRS, modeled on the Framingham Heart Study, is still in its early phase, but over 17,000 soldiers have now enrolled. We expect that the prospective study can build on these retrospective results to define risk factors for suicide, just as the Framingham study identified risk factors for cardiovascular disease….
By Thomas Insel, M.D.
It has become an NIMH mantra to describe mental disorders as brain disorders. What does this mean? Is it accurate to group schizophrenia, depression, and ADHD together with Alzheimer’s disease, Parkinson’s disease, and Huntington’s disease? Is a neurologic approach to mental disorders helpful or does this focus on the brain lead to less attention to the mind?
First, mental disorders appear to be disorders of brain circuits, in contrast to classical neurological disorders in which focal lesions are apparent. By analogy, heart disease can involve arrhythmias or infarction (death) of heart muscle. Both can be fatal, but the arrhythmia may not have a demonstrable lesion. In past decades, there was little hope of finding abnormal brain circuitry beyond the coarse approach of an EEG, which revealed little detail about regional cortical function. With the advent of imaging techniques like PET, fMRI, MEG, and high resolution EEG, we can map the broad range of cortical function with high spatial and temporal resolution. For the first time, we can study the mind via the brain. Mapping patterns of cortical activity reveals mechanisms of mental function that are just not apparent by observing behavior….
By Thomas Insel, M.D.
Researchers continue to make progress in the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Project, which seeks to intervene at the earliest stages of illness in order to prevent long term disability. Recent refinements to the two RAISE studies will ensure that RAISE continues efficiently, and generates results that will be relevant to consumers and health care policy makers.
The RAISE Early Treatment Program (ETP), led by John Kane, M.D., of the Feinstein Institute for Medical Research in Manhasset, NY, is now conducting a full-scale, randomized controlled trial comparing two different ways of providing treatment to people experiencing the early stages of schizophrenia and related disorders. Both types of treatment emphasize early intervention but feature different approaches for initiating and coordinating care. Treatment may include personalized medication treatment, individual resiliency training, and supportive services, such as family psychoeducation and education or employment assistance. A total of 34 study locations are scattered throughout the nation and are currently recruiting patients. ETP plans to recruit at least 400 patients for the study for up to two years of treatment and evaluation….
By Colleen Labbe
NIMH Press Office
New neurons growing in the adult brain help buffer the effects of stress, according to a new study in mice. Previous research has suggested that the growth of new neurons, or neurogenesis, in adults is involved in recovery from depression. This work provides evidence that loss of new neurons plays a role in the development of depression and suggests that the stress response is the link between adult neurogenesis and depressive illness….
By Charlotte Armstrong
NIMH Press Office