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

Cause and Effect: Standard Psychiatric Practice and Real World Outcomes

“We can't solve problems by using the same kind of thinking we used when we created them.”
Albert Einstein

The expert hired by the GAO to assess the report issued on an investigation done at the request of Senator Tom Carper into the psychotropic drugs prescibed to foster children is a research psychiatrist and a professor at the University of Washington.  Jon McClellan, is an expert on childhood schizophrenia, and there are countless professional journal articles, practice parameters and textbooks that he has written or contributed to which outline how to use psychotropic drugs "off-label."   The use of drugs off label is common in Medicine; however, "off-label" prescriptions are supposed to based on valid empirical evidence; and this is where psychiatry has went off the rails,  Some(all?) of the Standard Practices are developed without any relevant empirical data to support or validate them.  


"Off-label" use of psychiatric drugson children in Standard Practice is often not supported by any empirical data in the evidence base; in fact many recommendations are developed by consensus; simply because there is either insufficient empirical evidence or there is no evidence to base the recommendation on.  This is unscientific and unethical but widespread use of psychiatric drugs "off-label" with no empirical evidence to support their use is now Standard Practice in psychiatry.    


The GAO's expert, a leader in the field of child and adolescent psychiatry, acknowledged in a 2005 journal article that, "the justification for most practice is based on the adult literature or clinical consensus. Ultimately, pediatric mental health services need to be defined by research, rather than the current state whereby studies, if done at all, are initiated to justify existing practices. "  So, in effect, he is admitting that the drugs trials which provided the limited empirical data available in 2005, were conducted to validate what psychiatry had been doing in Standard Clinical Practice for years and years. The American Academy of Child and Adolescent Psychiatry had been and is still, recommending treatments to other medical professionals that have not been based on sound science or ethical medical principles.
McClellan admits that clinical drug trials have been conducted to validate existing Standard Practices; which is an admission that Standard Practices were not science-based when they were standardized and implemented by psychiatrists who encouraged others to use them as if they were. The Standards were not scientifically or ethically valid. Nonetheless, they became Standard Practices widely used by professionals who assumed the practices were derived from valid scientific research; not simply based on subjective opinions validated by a vote. A vote would not and could not transform a consensus of subjective opinions into valid scientific evidence; let alone one that could validate a treatment recommendation or standard, absent empirical data to support it. In other medical specialties, Standard Practices and treatment recommendations are derived from and based on the empirical evidence; with subjective opinions as support.  
Psychiatrists determined by a vote that a consensus of subjective opinions and anecdotal evidence could be used to validate Standard Practices and drug treatment algorithms they had been using for years without empirical evidence to support and validate them. Psychiatrists also determined by a vote that Standards for treating adults and the empirical data from drug trials for adults, is applicable to children. This short-sighted decision was necessary due to the "growing public concerns over safety, in particular with psychotropic medications," psychiatric practices were being scrutinized and needed to become (or at least appear to become) "empirically based"----


They were supposed to be empirically based from the beginning. (since psychiatry is a 'medical specialty' that is treating 'diseases' 'chemical imbalances' and/or  'neuro- biological' conditions caused by 'genetic defects')  The diagnoses themselves are determined by committee, and are voted into and out of existence by psychiatrists. It is a process which is fraught with controversy, and which has led to more and more human behaviors being used by psychiatrists to diagnose an ever increasing number of "mental illnesses"  
Psychiatry decided to claim these "mental illnesses" are caused by a disease or defect... Psychiatrists claim to be practicing science-based medicine, although psychiatrists have yet to offer definitive evidence that any psychiatric diagnosis is caused by a disease, an imbalance or a genetic defect. McClellan admits, "Variability in diagnostic and treatment practices, coupled with a lack of research, makes it difficult to stipulate which practices fall within or outside consensus or community standards. The limited validity for most childhood psychiatric disorders further complicates this issue (McClellan and Werry, 2000)

Consensus and Community Standards are not scientific standards; they are not even scientific. McClellan acknowledges, there is limited understanding of what the standards are. McClellan admits the diagnoses have limited validity, and limited understanding of what is or is not a psychiatric diagnosis, and what is and is not an effective and/or safe way to treat a diagnosis. So how is it possible to ethically declare as a scientific fact or a medical certainty that any psychiatric drug is 'effectively treating' any diagnosis?
In spite the seriously flawed methodology underlying all of this, psychiatrists have diagnosed, and have encouraged other professionals to diagnose more and more children with what are at the very least, potentially invalid diagnoses. Psychiatrists have then told children, their parents and the general public that the diagnoses are caused by diseases or biological abnormalities without offering any empirical evidence this is a valid claim. It is a claim made in hopes that it will ensure compliance with a recommended treatment protocol. A claim made with the intent to deceive, in order to benefit the professional by being perceived as an authority, and to compel compliance with a treatment protocol is fraud. It is not an ethical medical practice.
The AACAP and the NIMH and many advocacy groups state this claim as if it is a scientific fact on their websites and throughout their information and advocacy materials used to educate the public, to lobby for financial support and to formulate public policy, and to train Law Enforcement; effectively recruiting unwitting co-conspirators in their fraud. This fraudulent claim supports the interests of a criminal enterprise, not the interests of medical science and certainly not the interests of the patient. The advocacy groups are participating intentionally or not, supporting criminal activity by disseminating biased, and corrupt data as if it is valid information. As a result, widespread systemic Medicaid fraud is continuing unabated; a criminal enterprise that is openly aided and abetted by the unethical conduct of "professionals" and special interest "patient" advocacy groups.
How can anyone with a science-based or medical education not see the cause and the effect? Psychiatry has developed the diagnostic criteria, formulated and widely disseminated the treatment protocols, the diagnoses and treatments are 'discovered' by consensus and validated by a vote in the absence of valid empirical data. Both the diagnoses and the treatment protocols are the result of a political process that is quasi-democratic and takes place in secret. Members of the APA gather to determine who is and is not under their authority and control, who is going to be targeted for being adjudicated as "mentally ill" and in need of "special treatment" without their Individual Rights being effectively preserved or defended. This may not be the INTENT; however it is what is happening. I can assure you, the intent is not what victims are most aware of once they have lost their Liberty, their human dignity and/or their health; and are left with little hope of recovery.
The expert hired by the GAO, Jon McClellan, wrote some of the protocols, taught others how to use the protocols, and he has acknowledged he knew of the lack of scientific validity underlying the entire process. Consensus based diagnostic criteria and treatment algorithms being used as Standard Practices is 'the cause;' of the poor Standard of Care in Real World Practice; which becomes the cause of the patient's lousy Real World Outcome is the end effect.


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