Involuntary Transformation: 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.