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:

A Whistleblower Wins: Franz Gayl

I've featured Franz Gayl's story twice here and here on Involuntary Transformation.  The Senior Marine Corps Advisor, reported major safety issues which put troops at risk; then had to seek whistleblower protection when he was apparently retaliated against for doing his job with honor and integrity.

 I am happy to share that Marine Corps Major, (Ret.)  Franz Gayl has been officially reinstated; and he is looking forward to getting back to work.   Real happy to have such a positive outcome to report.

"He has honor if he holds himself to an ideal of conduct though it is inconvenient, unprofitable, or dangerous to do so."  Walter Lippmann

Pentagon whistleblower Franz Gayl is reinstated

This photo provided by Franz Gayl, a retired Major, shows Gayl in 2006 as a civilian science adviser in Iraq.Franz Gayl/AP Photo

Senior Marine Corps science advisor wins case, plans to return to work

By R. Jeffrey Smith

10:59 am, November 16, 2011 Updated: 11:32 am, November 16, 2011

A Navy review board has overturned a Marine Corps decision to strip one of its senior science advisors of his security clearances, intervening directly in a case that attracted attention among lawmakers on Capitol Hill and among advocates of enhanced legal protection for military whistleblowers.

Franz Gayl, who complained publicly in 2007 that the Corps had squashed an urgent request from U.S. soldiers in Iraq for heavily armored vehicles, was stripped of his clearances last year and suspended indefinitely with pay. The Corps acted after alleging that he improperly placed a thumb drive in his restricted office computer.

Gayl promptly accused his superiors of retaliating for his whistleblowing, and sought legal protection. But the Corps twice sought to end his pay, most recently in September. The last attempt was thwarted by the Office of Special Counsel, an independent agency, which asserted in a legal filing last month that Gayl “is a public whistleblower who has put his career at risk out of concern for the safety of service members in combat.”

The Navy board, ordering an abrupt turnaround in his predicament, said in a statement to Gayl on Nov. 7 that he was again eligible for needed clearances, even as it chastised him for “disregard for direction from your supervisor” and for failing to follow security procedures. Marine Brigadier Gen. Michael A. Rocco, who directs the Corps’ strategy and plans division where Gayl worked, responded with a message to Gayl that “I have decided to cancel the proposed indefinite suspension.”

Underpinning Gayl’s longrunning dispute with the Corps was its resistance to a wrenching policy shift at the height of the Iraq conflict away from the longstanding development of two new light troop and amphibious carriers to the quick production of a heavy vehicle, known as the MRAP, which officers and soldiers in Iraq said they needed to protect them from roadside bombs.

The shift was ordered in 2007 by Defense Secretary Robert Gates, who made MRAPs the Pentagon’s top procurement priority partly because of news reports recounting Gayl’s complaints about Marine Corps foot-dragging. To the chagrin of some Corps leaders, one of the lighter carriers was eventually cancelled because of its high costs and other problems.

In meetings with lawmakers that year, Gayl accused the Corps leadership of institutional inertia and said its commanders were too wedded to programs that were already funded; he further charged that their failure to monitor and respond to an urgent request from the battlefield had caused needless deaths. He argued that his remarks were protected by civil service whistleblowing protections.

Then-Sen. Christopher Bond (R-Miss.) and then-Sen. Joseph Biden (D-Del.) wrote a joint letter warning the Corps not to punish Gayl; nonprofit groups such as the Project On Government Oversight organized a petition offering support. But after the Corps suspended Gayl for allegedly disregarding regulations and what it said was “a pattern of poor judgment and intentional misconduct,” Biden decided he could not intervene from the Vice President’s office, according to one of his aides.

After the special counsel’s office demanded a 45-day stay of the Corps’ decision to cut off Gayl’s pay this year, the Merit Systems Protection Board — an independent, quasi-judicial agency that polices civil service rules — issued the first official rebuke to the Marines. It concluded on Oct. 13 that “there are reasonable grounds on which to believe that Mr. Gayl’s indefinite suspension is a result of his protected activity and is therefore prohibited.”

The final decision, by a group formally called the Navy Central Adjudication Facility, came four weeks later. “I am very encouraged that the Pentagon appears to have finally come to the realization that Mr. Gayl is not the enemy, and that our military will be much safer if whistleblowers are valued and not exiled,” said Jonathan Cantu, his attorney at the nonprofit Government Accountability Project in Washington.

A spokesman for the Marines, Maj. Stewart Upton, said "personnel matters involving federal employees are subject to privacy laws and regulations.  The Marine Corps takes very seriously the proper handling and resolution of any employee issues, and as in any other case we are taking the appropriate actions."

Gayl, in a statement released Wednesday morning by the Project, said that “I am as committed as ever to return to the Marine Corps to work hard in support of all Marines.”

Reprinted with permission 

End Retaliation against the Whistleblower Who Saved Thousands of Troops' Lives

Even a baby can Provoke Accountability!

 Via: GovtOversight's Channel

via POGO Blog:

End Retaliation against the Whistleblower Who Saved Thousands of Troops' Lives

By BRYAN RAHIJA

Franz Gayl isn't exactly a household name, but he should be. Thanks to him, thousands of troops' lives in Iraq and Afghanistan have been saved.

Don't take it from me though--take it from former Secretary of Defense Robert Gates, who recently said in an interview that "thousands and thousands of lives have been saved and multiples of that in terms of limbs" by Mine Resistant Ambush Protected vehicles (MRAPs).

What's the connection between Gayl and MRAPs? Gayl, a science advisor to the Marines, blew the whistle in 2007, alleging that the Pentagon was ignoring urgent requests for MRAPs from Marines in Iraq. After his disclosures, Congress started to ask questions, spurring the Pentagon to hustle and secure delivery of thousands of MRAPs to Iraq and Afghanistan.

The troops eventually got what they needed. Gayl, however, got retaliated against. In October he was stripped of his security clearance, a move that effectively ended his career.

Not only is this retaliation a gross injustice to a patriotic public servant, but it sends a troublesome message to others who witness wrongdoing in the federal government: stay quiet.

Now, POGO, along with our friends at the Government Accountability Project (GAP) are urging our readers and supporters to help right this wrong. If you'd like to take a stand for whistleblowers, government accountability, and the troops, please take a moment today to write Secretary of Defense Leon Panetta and urge him to reinstate Gayl's security clearance so that Gayl can have his career back. Gayl deserves praise for his courageous actions—not retaliation.

Bryan Rahija edits POGO's blog. You can read more about Gayl in a recent profile in The Washington Monthly and on GAP's blog.

Whatever happened to integrity? Anonymous

"Quotationary"  Leonard Roy Frank

                       "Marine Corps integrity is doing that thing which is right, when no one is looking."

Col. Colin Lampard, USMC