Neurotrauma and Psychological Health Project and Cooperative Studies

Violating the Hippocratic Oath and the Oath to preserve and defend the Constitution.

Broken Warriors

via Stars and Stripes:

Army, VA partner for PTSD drug study

By COURTNEY MABEUS

The Frederick News-Post

Published: July 15, 2012

Studies show the average person with PTSD waits 12 years before being treated. Col. Charles Engel, a Walter Reed National Military Medical Center doctor, said each month 100,000 soldiers are screened for PTSD.

RUSSELL MIDORI/DVIDS

"An Army office at Fort Detrick and a veterans program are teaming up to study drugs that could help treat combat-related post-traumatic stress disorder.


"The U.S. Army Medical Materiel Development Activity's Neurotrauma and Psychological Health Project Management Office has signed an agreement with the Department of Veterans Affairs Cooperative Studies Program that will help guide the studies, which could begin in about a year.


"Clinical studies at locations across the U.S. will take an additional 24 to 36 months to complete, according to Maj. Gary Wynn of USAMMDA, which is based at Fort Detrick.


"We're not just looking to do a study, we're looking to do a program," Wynn said.


"Wynn, a research psychiatrist who also works at Walter Reed National Military Medical Center in Bethesda, is chairing the effort for the Department of Defense.


"The goal is to identify drugs already on the market that may help in treating PTSD and seek U.S. Food and Drug Administration approval for their specific use in treating the disorder, Wynn said. In some cases, health care providers may already be using certain drugs off-label to help, Wynn said, but they are not approved for use.


"Providers have found certain drugs help aspects of (PTSD), but nothing has been studied to the FDA level," Wynn said.


"Only two drugs, paxotene, known as Paxil, and Zoloft, are approved for the treatment of PTSD, Wynn said.


"The disorder's symptoms include flashbacks, loss of sleep and nightmares. Its cause is unknown, according to the National Institutes of Health.


"Studies have shown that 10 to 15 percent of soldiers who deploy in a given year may develop PTSD, Wynn said.


"Researchers are eyeing 10 to 20 drugs that might be helpful for treatment, Wynn said, including Seroquel, an antipsychotic, and Lunesta, which is used to treat insomnia." here

This announcement comes less than three months after the Army Surgeon General and Army Medical Command warned doctors against using psychotropic drugs for PTSD; citing fatal risks and lack of efficacy.

The question is why is the DoD and the Department of Veterans Affairs partnering to study drugs that are known to have fatal risks when it is known the drugs are not effective treatment for PTSD? The answer is given by Major Gary Wynn; a psychiatrist, who reports the purpose of the drug trials will be to, "seek U.S. Food and Drug Administration approval for their specific use in treating" PTSD.  This is not a valid ethical purpose for conducting a drug trial using human subjects. It is what is referred to as a 'seeding trial,' the primary purpose of which is to expand the market for a particular drug; or in this case, multiple drugs.  Why is the US Government planning on conducting and paying for research which is obviously unethical, and plainly nothing more than a part of the pharmaceutical industry's drug marketing strategy?

Why is the DoD and Veterans Affairs not announcing that it is going to make it a priority to fund the type of treatment that has empirical evidence of being effective for treating PTSD?  Apparently, ensuring that the military continues to be a source of revenue long term for the pharmaceutical industry takes precedence over providing effective non-lethal treatment for our troops with Post Traumatic Stress Disorder.

Major Gary Wynn is a psychiatrist and is going to head this project.  Since the drugs are already known to be ineffective, and multiple warnings have been issued cautioning against using them to treat PTSD due to risk of fatality and the drugs inefficacy; it is a violation of the ethical guidelines of the medical profession, to even prescribe them for PTSD. "First, do no harm..." These drug trials are not for the primary benefit of the troops who have PTSD. It is obvious that the preservation and defense of the individual rights; i.e. Constitutional Rights, of the troops who will be used as research fodder in what is clearly Human Experimentation is not even a concern; it's morally reprehensible. 

last month in Navy Times:
DoD cracks down on off-label drug use

"The message from Air Force Lt. Gen. Brooks Bash informed White that U.S. Central Command had decided in March to remove the powerful antipsychotic drug Seroquel from its approved formulary list." here


via Air Force Times: 
Army launches study of PTSD meds

By Patricia Kime - Staff writer
Posted : Tuesday May 8, 2012 16:21:49 EDT

"Military and Veterans Affairs Department physicians often prescribe medication to ease the symptoms of combat-related post-traumatic stress disorder, even though only two antidepressants — Paxil and Zoloft — are approved specifically by the Food and Drug Administration to treat the disorder.

"But little data exists on which “off-label” medications work and which don’t.

"The Army is hoping to change this, launching a major research initiative next year on the effectiveness of commonly prescribed medications for PTSD.

"Speaking at the American Psychiatric Association meeting in Philadelphia on Monday, Army Maj. Gary Wynn of the Walter Reed Army Institute of Research and Col. David Benedik, associate director for the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences, said the service will start clinical trials next year to evaluate commonly prescribed PTSD medications such as the antidepressant Cymbalta, mirtazapine, prazosin, and atypical antipsychotics like Seroquel." here

via NextGov Broken Warriors April 25, 2012:

ARMY WARNS DOCTORS AGAINST USING CERTAIN DRUGS IN PTSD TREATMENT


"The Army Surgeon General's office is backing away from its long-standing endorsement of prescribing troops multiple highly addictive psychotropic drugs for the treatment of post-traumatic stress disorder and early this month warned regional medical commanders against using tranquilizers such as Xanax and Valium to treat PTSD.

An April 10 policy memo that the Army Medical Command released regarding the diagnosis and treatment of PTSD said a class of drugs known as benzodiazepines, which include Xanax and Valium, could intensify rather than reduce combat stress symptoms and lead to addiction.

The memo, signed by Herbert Coley, civilian chief of staff of the Army Medical Command, also cautioned service clinicians against prescribing second-generation antipsychotic drugs, such as Seroquel and Risperidone, to combat PTSD. The drugs originally were developed to treat severe mental conditions such as schizophrenia and bipolar disorder. The memo questioned the efficacy of this drug class in PTSD treatment and cautioned against their use due to potential long-term health effects, which include heart disorders, muscle spasms and weight gain."  read here

via NextGov Broken Warriors August 2011: 

VA SPENT $717 MILLION ON A DRUG DEEMED AS EFFECTIVE AS A PLACEBO

"Over the past decade, the Veterans Affairs Department spent $717 million for an anti-psychotic drug to treat post-traumatic stress disorder that a recent study shows is no more effective than a placebo."

"While the paper on risperidone published earlier this month reported the results of the first large trial measuring the effectiveness of second-generation anti-psychotics in the treatment of PTSD, previous research found little evidence the drugs were effective and VA's own clinical practice guidelines, first published in 2004, when the department spent $66 million on risperidone and $56 million on Seroquel, warned against using the drugs to treat PTSD." here


In 2011 it was announced that Venlafaxine became a "First- Line Treatment" for PTSD even though it is not FDA approved to treat PTSD.

via Clinical Psychiatry News 3-11-11
Venlafaxine Becomes First-Line PTSD Therapy in Latest VA Guidelines


"The new Veterans Affairs/Department of Defense (VA/DoD) evidence-based guidelines strongly recommend that all adults with PTSD be offered pharmacotherapy with a first-line agent. That means either an SSRI, for which the strongest evidence of benefit exists for sertraline, paroxetine, and fluoxetine, or a serotonin norepinephrine reuptake inhibitor (SNRI), among which venlafaxine has the strongest supporting evidence, said Dr. Villarreal, a psychiatrist at the University of New Mexico, Albuquerque, and the New Mexico VA Health Care System." here

The Entire Broken Warriors Series from NextGov

Soldiers who have committed suicide / homicide while on psychiatric drugs

The Drugging of U.S. Troops

Broken Warriors is an ongoing series on mental health issues in the military.

via NextGov:

ARMY WARNS DOCTORS AGAINST USING CERTAIN DRUGS IN PTSD TREATMENT

By Bob Brewin April 25, 2012
Flickr user deanslife 

The Army Surgeon General's office is backing away from its long-standing endorsement of prescribing troops multiple highly addictive psychotropic drugs for the treatment of post-traumatic stress disorder and early this month warned regional medical commanders against using tranquilizers such as Xanax and Valium to treat PTSD.

An April 10 policy memo that the Army Medical Command released regarding the diagnosis and treatment of PTSD said a class of drugs known as benzodiazepines, which include Xanax and Valium, could intensify rather than reduce combat stress symptoms and lead to addiction.

The memo, signed by Herbert Coley, civilian chief of staff of the Army Medical Command, also cautioned service clinicians against prescribing second-generation antipsychotic drugs, such as Seroquel and Risperidone, to combat PTSD. The drugs originally were developed to treat severe mental conditions such as schizophrenia and bipolar disorder. The memo questioned the efficacy of this drug class in PTSD treatment and cautioned against their use due to potential long-term health effects, which include heart disorders, muscle spasms and weight gain.

Throughout more than a decade of war in Afghanistan and Iraq, the military services have relied heavily on prescription drugs to help troops deal with their mental health problems during and after deployment. In a June 2010 report, the Defense Department's Pharmacoeconomic Center said 213,972, or 20 percent of the 1.1 million active-duty troops surveyed, were taking some form of psychotropic drug -- antidepressants, antipsychotics, sedative hypnotics or other controlled substances.

The Army, in a July 2010 report on suicide prevention, said one-third of all active-duty military suicides involved prescription drugs.

'Soldiers' Secrets'

via OfficialPostSecret

Seeding Trials planned in an effort to validate current clinical practice

On April 27th I wrote about the Army's Surgeon General, warning against the use of neuroleptic and other psychotropic drugs to treat the symptoms of PTSD. Today, I see a link to Army launches study of PTSD Meds on the Mad in America site---I can't help but think this is a response to the Army Surgeon General's office backing away from it's long standing endorsement of using psychotropic drugs to treat PTSD. Herbert Coley, civilian chief of staff of the Army's Medical Command issued a memo citing lack of efficacy and the serious risks of using neuroleptic and other addictive neurotoxins as the reason for issuing a warning against using psychiatric drugs to treat PTSD. This current announcement was made initially at the American Psychiatric Association's meeting in Philadelphia on May 5th by Army Maj. Gary Wynn of the Walter Reed Army Institute of Research and Col. David Benedik, associate director for the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences, and reported in Air Force Times appears to be announcing a plan to conduct 'seeding trials.' Seeding Trials are drug trials conducted with the primary goal of validating 'off-label' prescribing practices, gaining FDA approval to use a drug for a different symptom, and EXPAND THE DRUG MARKET. Obviously, this is unethical, This decision announced at the APA convention should be recognized as a decision to continue serving the profit interests of the drug industry, it cannot be a decision made with the well-being and recovery of Veterans experiencing PTSD as the primary focus. I wonder if Veteran's recovery was considered at all...

I cannot help but be amazed at how openly it is being acknowledged that the drugs used 'off-label' to treat PTSD without any definitive evidence to support using the drugs this way; is in fact a Standard Practice.  Using psychiatric drugs 'off-label' is not a decision  based on objective scientific data or ethical medical standards; it is based on Standard Practices and practice parameters which were adopted in the absence of objective, empirical evidence to support or validate them; ignoring fundamental, ethical medical principles.  Specifically, the principle that treatments used in Standard Practice are supposed to be derived from valid evidence of efficacy...including a risk profile which is justified by the actual benefits achieved.  The article in the Air Force Times makes it crystal clear that the treatment of PTSD for Veterans with neurotoxic psychiatric drugs is not now, and has never been based on Scientific Evidence or sound medical judgement.  

It is Human Experimentation to use drugs or other  treatments without valid evidence of effectiveness  and safety... This means that ethical medical principles are not being used when psychiatric drugs are prescribed 'off-label.'   Psychiatric treatment using drugs "off-label" that is not based on any valid or relevant evidence ignores sound medical reasoning altogether.  Small wonder the  bio-disease paradigm is an abject failure in terms of providing ethical, effective patient-centered care. Ethical clinical care requires that treatment decisions be based on ethical medical principles.  Fundamental principles of providing ethical clinical care require a clinician's primary focus be the individual patient's best interest.  This requires an honest dialogue which is respectful and honest. A professional has a duty to fully inform the patient about the diagnosis and the treatment options, which includes doing nothing; i.e. no treatment.  Informed Consent must be obtained without coercion or fraudulent claims and informing the patient about the potential risks and the possible benefits truthfully; and includes supporting the person who makes the decision to consult others of their own choosing.  Informed Consent is obtained prior to treatment starting, and is it is not a final decision; but is supposed to be an ongoing dialogue. Consent can be withdrawn without fear of or threat of punitive action, coercion or abuse of authority.

Three sentences in the article in particular indicate that treatment of PTSD with psychiatric drugs is without scientific validity; making it experimental treatment:

1. "But little data exists on which “off-label” medications work and which don’t."  

2. "Physicians still assess their patients and treat their symptoms based on their own medical experience as well as patient history and treatment preferences." 

3. “We’re trying to advance the science to catch up with clinical practice,” Wynn said. “This effort will seek to provide clinicians with a higher level of evidence when choosing a drug.” 

Theoretically, treatments used in Standard Practice are derived from scientific evidence, e.g. BASED on empirical evidence that a drug is safe and efficacious treatment for the condition it is being prescribed for; with the data supported by subjective observation and opinion.  In the biomedical paradigm of psychiatric care, standard treatment recommendations are overly reliant upon and sometimes entirely derived from subjective opinions.  A consensus of even well-educated opinions is no substitute for scientific evidence, and pretending that it is is ethically and morally reprehensible.   Clinical treatment "standard practices" are often not supported by the evidence; in some cases, the treatment is contraindicated by the clinical trial data making it unethical and unnecessarily risky. 

Psychiatry is using a bio-medical paradigm not grounded in valid research findings

or based on ethical medical principles.

  

via Air Force Times: 

By Patricia Kime - Staff writer
Posted : Tuesday May 8, 2012 16:21:49 EDT

Military and Veterans Affairs Department physicians often prescribe medication to ease the symptoms of combat-related post-traumatic stress disorder, even though only two antidepressants — Paxil and Zoloft — are approved specifically by the Food and Drug Administration to treat the disorder.

But little data exists on which “off-label” medications work and which don’t. 

The Army is hoping to change this, launching a major research initiative next year on the effectiveness of commonly prescribed medications for PTSD.

Speaking at the American Psychiatric Association meeting in Philadelphia on Monday, Army Maj. Gary Wynn of the Walter Reed Army Institute of Research and Col. David Benedik, associate director for the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences, said the service will start clinical trials next year to evaluate commonly prescribed PTSD medications such as the antidepressant Cymbalta, mirtazapine, prazosin, and atypical antipsychotics like Seroquel.

VA and the Defense Department published joint guidelines in 2010 to provide doctors with assessments of the known research on many psychiatric medications used for PTSD.

But the guidance, which recommends strongly against the use of benzodiazapines like Valium and Xanax and several other medications, is not absolute. Physicians still assess their patients and treat their symptoms based on their own medical experience as well as patient history and treatment preferences.

Often this means prescribing medications developed to treat other mental conditions.

The Army research will test commonly prescribed medications over the next several years at multiple sites with hundreds of service members and veterans.

“We’re trying to advance the science to catch up with clinical practice,” Wynn said. “This effort will seek to provide clinicians with a higher level of evidence when choosing a drug.”

Wynn and Benedik hope their efforts will lead to better treatments for PTSD in both combat veterans and civilians.

“For pharmaceuticals that show benefits in treating combat-related PTSD, the Department of Defense may work toward a new indication or change in labeling,” Wynn said.

Published results from the first trial are expected by 2016.

First-Line Pharmacological Treatment For PTSD: Developed From Insufficient Evidence

Do neuroleptics like Seroquel and Risperdal, have a valid medical purpose used "off-label"?

Champions of Change? God Bless America and Protect Her Defenders...

FYI:

What is an Award? Two awards, one is unearned and one is earned heroically

via: NIMH
For the second time in less than a year, the National Institute of Mental Health and its researchers have been honored by the White House. On August 25th, NIMH and eight suicide prevention organizations were named recipients of the administration’s Champions of Change initiative.  here is what I thought of this God Bless America  This announcement bothered me on so many levels.  I wondered, how much is this collaboration costing?  So I found out.

via NIMH: NIMH and the U.S. Army have entered into a memorandum of agreement (MOA) to conduct research that will help the Army reduce the rate of suicides. NIMH Director Thomas R. Insel, M.D., Army Secretary Pete Geren, and Army Chief of Staff Gen. George W. Casey Jr. signed the MOA on October 23, 2008.

The MOA allows for a $50-million, multi-year study on suicide and suicidal behavior among soldiers, across all phases of Army service. It will be the largest single study on the subject of suicide that NIMH has ever undertaken.

The joint project will strengthen the Army’s efforts to reduce suicide among its soldiers by identifying risk and protective factors for suicidal thinking and behavior. It will help the Army develop more effective intervention programs and target them where they are most needed.

Benefits of the study will go beyond the Army. The study’s findings will also inform our understanding of suicide in the U.S. population overall, and may lead to more effective interventions for both soldiers and civilians. Every year, an average of 30,000 Americans die by suicide.

Specific details of the project are still being worked out in the NIMH Division of Services and Intervention Research.

STARRS The Army Study to Access Risk and Resilience in Service Members at NIMH


via Army STARRS a nonprofit website:

Army Study To Assess Risk and Resilience in Service members

Army STARRS is the largest study of mental health risk and resilience ever conducted among military personnel.

Beginning in 2011, Army STARRS investigators will look for factors that help protect a Soldier’s mental health and those factors that put a Soldier’s mental health at risk. Army STARRS is a five-year study that will run through 2014; however, research findings will be reported as they become available so that they may be applied to ongoing health promotion, risk reduction, and suicide prevention efforts. Because promoting mental health and reducing suicide risk are important for all Americans; the findings from Army STARRS will benefit not only servicemembers but the nation as a whole.

Army STARRS Preliminary Data Reveal Some Potential Predictive Factors for Suicide

Early examination of data from the U.S. Army’s Total Army Injury and Health Outcomes Database (TAIHOD) has revealed potential predictors of risk for suicide among soldiers. Preliminary results were provided by researchers leading the ongoing Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS). Army STARRS, a partnership between NIMH and the U.S. Army, is the largest study of mental health risk and resilience ever conducted among military personnel.

The TAIHOD database includes information from Regular Army soldiers (not Guard or Reserve Component soldiers) and covers the period between 2004 and 2008. Army STARRS researchers compared data on all suicides, accidental deaths, and combat deaths in an effort to identify patterns and predictors among the three types of deaths.

The following findings are preliminary. They involve relatively few descriptive predictors and do not account for complex events or interactions. Researchers plan to do additional work with a much larger historical dataset and with survey data from the All Army Study and the New Soldier Study (two Army STARRS components) to test these initial findings.

The main preliminary findings include the following: read here.

                                    What is missing?  

Any mention of the psychotropic drugs used to "treat" symptoms of PTSD, depression, anxiety, etc. as being a factor deserving consideration.   I find it strange that on the Army STARRS website there is no mention of prescription drugs AT ALL-- that I could find.  I would imagine that the TAIHOD database should also be collecting the information about psychotropic drug treatment that the troops are receiving; what drugs and combinations of drugs are prescribed, to those who have attempted or committed suicide/homicide; as well as information about illicit drug and alcohol use.  It is more than strange, (to say the least) that these relevant factors are apparently not being investigated.

Now this is a study that is attempting to determine what factors make an individual resilient; factors such as ethnicity, gender, deployment history are being examined.  The psychotropic drugs prescribed to our troops is a factor, although it is apparently not one being considered.  Psychotropic drugs are still being used as "first line treatment" for symptoms of PTSD, in spite of the fact that this "Standard Practice" in known to be ineffective and costly: it is fiscally, socially and medically unsound; yet it is still Standard Practice.

via Next Gov:"The Veterans Affairs Department continues to issue contracts to purchase an anti-psychotic drug to treat post-traumatic stress disorder despite research showing the drug, risperidone, is no more effective than a placebo."read Va Awards... for debunked PTSD drug

summary:  

This Champions of Change award is given shortly before the half way point of a six year joint collaboration.  In the three years since the Army approached the NIMH, the suicide rate has doubled among Military personel.  We still are losing high numbers of sons and daughters, who have served Our Country to suicide---strangely,  the ineffective and unsafe teratogenic drugs prescribed to troops that are known to cause suicide, are not a factor being investigated.

The fact that psychotropic drugs known to cause suicide are not a factor considered relevant  to this joint endeavor, means that the NIMH deserves special recognition: 

A Champion of Change Award

for changing nothing, is not an earned Award.

via Borepatch: Semper Fi

Thank you for your service to the United States of America Sergeant Meyer!

via The Marines page Medal of Honor

“I am extremely pleased by the news that the President has announced that he will award the Medal of Honor to Sergeant Dakota Meyer.

Sergeant Meyer embodies all that is good about our nation's Corps of Marines. He is a living example of the brave young men and women whose service, fidelity and sacrifice make us so proud.

Sergeant Meyer's heroic actions on September 8, 2009 in the Ganjgal village in Afghanistan serve as an inspiration to all Marines and will forever be etched in our Corps' rich legacy of courage and valor.

Speaking on the behalf of all Marines, I congratulate Sergeant Meyer on this auspicious news and look forward to his award ceremony here in Washington, DC in mid-September.”

— General James F. Amos, 35^th Commandant of the Marine Corps

This isn't about me.  If anything comes out of this for me, it's for those guys."  
Sgt. Dakota Meyer