Wide awake but soon to be in the dark: Washington State's failure to follow Medicaid Guidelines and to comply with a State Supreme Court Order

The State of Washington owes me several thousand dollars in back-pay, plus interest. For three years and eight months the Department of Social and Health Services Home and Community Care office through S.E. Washington Aging and Long Term Care took between 9 and 20 hours of pay out of my paycheck each month in violation of Federal Medicaid Guidelines; and in contempt of a Washington State Supreme Court Order.  Today, the power is going to be turned off, my phone has already been turned off. None of the programs that help people in a crisis has any funds to help keep our power on. I have been without an income since being wrongfully terminated from my contract as my son's care provider on October 30, 2012 by DSHS employee, Dirk Bush, who told me he didn't need a reason. This occurred when I pointed out he had slandered me when he falsely told a client that I was ineligible to be a care provider; he claimed that I had been convicted of a felony for abandoning a client---Bush knew this was not true; he had a copy of my background check. I have been without a paycheck for months. I managed to stay afloat thanks to my tax return; it is now totally gone.

The same person who claimed there is nothing wrong with the State violating Medicaid Law and being in contempt of a Washington State Supreme Court Order and illegally refusing to pay me for all of the hours assessed as necessary for my son's care, Jackie Klingele, represented the department in the Administrative hearing held because we are disputing the wrongful termination of my contract as my son's care giver. The Administrative Law Judge's decision is due to be mailed on April 19, 2013.   

"Someone in our society must make decisions with regard to the safety and effectiveness of new drugs..."

"Someone in our society must make decisions with regard to the safety and effectiveness of new drugs. This someone, of course, is the Food and Drug Administration. We have this responsibility — and a very grave one it is — by law. The decision -making process can conveniently be regarded as a three-step operation:

Step 1. Determine the benefit to be derived from the drug;

Step 2. Determine the risk;

Step 3. Weigh the benefit against the risk and decide whether it is in the public interest to approve the drug for marketing or to withdraw approval if the product is already on the market.

The decision to approve a drug for marketing, or to withdraw an earlier approval requires a weighing of the benefit to be expected from the use of the product against the risk inherent in its
use. While this is the same type of decision a physician makes each time he prescribes a drug for a patient, the government must consider a number of factors not pertinent to the individual
physician's decision.

The government must make a judgment as to the hazards likely to be encountered when the drug is employed: by physicians of varying skills and abilities, in patients with a multitude of disease processes, many occurring concurrently, and in patients incorrectly diagnosed or inadequately tested with accepted laboratory procedures."
former Commissioner of the FDA, George P. Larrick in Hearings Before Subcommittee of Committee on Government Operations, Drug Safety, fi.R., 88th Cong., 2d Sess., 149-154
(1964)

This post shares some of the testimony offered in Senate Hearings that took place in July and August in 1975. The hearings were part of an investigation into the off label use of psychotropic drugs in general and  neuroleptic drugs, called "antipsychotics" or "major tranquilizers" off label to control behavioral problems exhibited by children with mental retardation, (now called intellectual disabilities, or developmental disabilities) in institutional settings.  The DRUGS IN INSTITUTIONS HEARINGS BEFORE THE SUBCOMMITTEE TO INVESTIGATE JUVENILE DELINQUENCY OF THE COMMITTEE ON THE JUDICIARY UNITED STATES SENATE NINETY-FOURTH CONGRESS FIRST SESSION Pursuant to S. Res. 72, Section 12 INVESTIGATION OF JUVENILE DELINQUENCY IN THE UNITED STATES THE ABUSE AND MISUSE OF CONTROLLED DRUGS IN INSTITUTIONS

What struck me in reading the transcript of this Senate Hearing from 1975, is the similarities to the Senate Hearing chaired by Senator Tom Carper held on December 1, 2011 the same underlying problems were identified:  

1. The indiscriminate use of psychotropic drugs off label in quantities and combinations that belie ethical medical judgement, for symptoms that the drugs are not known to treat. 

2. Illegal marketing of psychotropic drugs, false claims exaggerating the effectiveness of the drugs used juxtaposed with minimizing the risks, including rates of adverse effects and adverse outcomes.

3. The medically negligent care provided to patients prescribed psychotropic drugs in standard clinical practice, both in community clinics and in institutional settings. The abusive inhumane methods used by professionals when patients are difficult, uncooperative, or considered a problem. 

4. The abject failure of the FDA to perform it's regulatory duties in a manner consistent with it's legislative mandate, i.e. to protect the American people from the dangers posed by FDA-approved drugs. The failure of the FDA was clearly and eloquently outlined in the testimony offered in 1975; and if anything, it has become worse since then. 

5. The utter failure of Law Enforcement to criminally prosecute or even investigate obviously criminal conduct of medical professionals and pharmaceutical representatives---The only difference now is the criminal behavior is more common, more visible, and more is now vehemently defended by psychiatrists and the pharmaceutical industry; who are effectively aided and abetted in their criminal complicity by the regulatory authorities that theoretically protect and serve us. 

Excerpts from the testimony offered by Dennis J. Lehr, a partner in the Washington, D.C. law firm of Hogan & Hartson:

We went to the FDA on July 16, 1974, and filed a detailed petition, saying, in effect; gentlemen, here is the evidence that shows drugs are being used in 300-, 400-, 1,000-percent dosages above their prescribed use. You know that Stelazine, Thorazine, Mellaril, and all of the other psychotropic drugs are being used for uses for which they were never proven safe and effective. Do something about it. Unfortunately, Thorazine came in for most of the raps today, but all of the psychotropics are being overused.

The Food, Drug and Cosmetic Act and the FDA's own regulations and relevant legislative history, say that when you are using a drug for an unapproved use or for an unapproved patient population for which it has never been heretofore been proven safe and effective, there must be a new drug application filed. This was never done and the FDA has not meaningfully addressed itself to the issues we have raised. Instead they referred us to a learned panel of doctors. Again, very well-meaning learned people; psychiatrists, pharmacologists, and psychologists. We sat with those people defended again, the very facts that they are fully aware of : That there are abuses.

We are making a legal argument to the FDA. But they are responding to us with anecdotal reports from a psychiatrist's practice.

MAKE FDA ABIDE BY OWN RULES AND REGULATIONS

In summary, what I am saying is, we want the help of this committee to tell the FDA : Do what Congress has told you to do. We have made seven recommendations, four of which go to revising the package inserts on these major tranquilizers, one of which goes to the institutions to put them on notice to stop this abuse. The fifth one deals with attacking the problem of not fully qualified and licensed physicians, and I will get back to that in one moment. And the last one, and this is the great sacred cow, asks for an investigation of the detailed practices of the drug companies. That is, the sales techniques used by the drug companies to sell psychotropic drugs to institutions. (emphasis mine)

The FDA will act even though the ultimate use of the drugs might be pursuant to valid prescriptions where, as in the case of phenothiazines, the practice of prescribing a new drug for an unapproved use "becomes widespread or endangers the public health." In such circumstances, the FDA's own proposed regulations recognize that the agency is "obligated to investigate . . . thoroughly and take whatever action is warranted to protect the public. . . ."

In our paper, we consider the legislative history of the Act and the relevant case law which supports the proposition that drugs cannot lawfully be used for purposes or patient populations not specifically approved by the FDA. A broad range of administrative and legal sanctions is available to both the FDA and the courts to deal with the unapproved use of approved drugs. Since the use of phenothiazines for the control of retarded persons is not in accord with the provisions of Section 355 because a supplemental new drug application has not been filed, the penalty and injunctive provisions as well as the seizure provisions of the Act become applicable. Moreover, as I mentioned earlier, the FDA has issued proposed regulations outlining its administrative responsibilities with respect to the unapproved use of approved drugs. The Notice of Proposed Rulemaking specifically would give the FDA authority to pursue, among other things, one or more of the following courses of action where the unapproved use of a new drug becomes widespread or endangers the public health :

(1) Revision of the package insert may be required to add a specific contraindication or warning against the unapproved use.

(2) The manufacturer may be required to obtain and submit the available data with respect to the unapproved use, or to sponsor clinical trials to determine the safety and effectiveness of the drugs for the unapproved use.

(3) Revision of the package insert may be required to state that the drug should be distributed only through specified channels (e.g., hospital pharmacies) and/or should be prescribed, dispensed, or administered only by physicians with specified qualifications.

(4) The approval of the new drug application may be revoked.

Thus the FDA has adequate authority to deal effectively with the unapproved use of phenothiazines. Yet, the agency has done little in the year since we filed our petition. Instead of undertaking a careful review of the scope of the problem and a scientific analysis of existing literature, the FDA has pursued a tortured course characterized by long delays and a desperate effort to find some evidence, regardless of quality or the existence of contrary evidence, upon which to justify a finding that the drugs are safe and effective. For example, there was so little action at the FDA in response to our July 1974 petition that it was necessary to file a supplementary petition in November of 1974. In that supplementary petition, we restated our position that the drugs had never been approved by "the FDA and that the FDA was therefore obligated to take
immediate action to do what it could to prevent continued unapproved use of an approved drug.

We also specified the action we thought was required :

"(1) Require that all package inserts contain a statement that the drugs have not been approved for tlie control or management of resident behavior in institutions for the mentally retarded, absent a diagnosis indicating the presence of a specifically identified psychotic condition or other specifically identified conditions for which the drug has previously been approved.

"(2) Require that the term "disturbed children" in the package inserts for Mellaril, Thorazine or any other phenothiazine be deleted and be replaced with more precise language which indicates that the drug is approved for the treatment of only those children who have been diagnosed as having a specifically identified psychotic condition or other specifically identified conditions for which the drug has been previously approved.

"(3) Require that all package inserts for phenothiazines contain a clear warning that recent studies show the drugs may impair cognitive abilities in the short run, that no acceptable studies have been done which indicate whether and to what extent the drugs may impair cognitive abilities in the long run, and that impairment of cognitive abilities is particularly harmful to children and mentally retarded persons. (emphasis mine)

"(4) Require revision of the package insert for each phenothiazine to state that special precautions and monitoring must be used because institutionalized mentally retarded persons may not be able adequately to verbalize or communicate adverse effects.

"(5) Notify all institutions for the mentally retarded that phenothiazines are not approved for the control of behavior unless a mentally retarded resident has a diagnosed, specifically identified psychotic condition or other specifically identified conditions for which the drug has been previously approved.

"(6) Require revision of the package insert for each phenothiazine to state that the drug should be prescribed only by fully licensed physicians and not by medical personnel with licenses limited to institutional practice.

"(7) Initiate immediately an investigation of the advertising, distribution and marketing practices of the phenothiazine manufacturers to determine whether and to what extent they are promoting or knowingly shipping phenothiazines for the purpose of managing and controlling the mentally retarded in violation of Section 505 of the Food, Drug and Cosmetic Act."

It was not until January 30, 1975, however, that we received any formal response from the FDA. By letter dated January 30th, a copy of which is submitted herewith as Exhibit D, we were advised that the FDA had ordered minor changes in labeling of one drug and that hearings had been scheduled before the Pediatric Advisory Panel of the Psychopharmacological Agents Committee.
In preparation for those hearings, the staff of the Bureau of Drugs reviewed the NDA files for phenothiazines and prepared a memorandum which was forwarded to us under cover of letter dated February 5, 1975, a copy of which is submitted herewith as Exhibit E. As was indicated above, that memorandum concluded that of the 24 studies of phenothiazines which included mentally retarded subjects, (only one was controlled, and even that was of limited value
because, of the 60 subjects participating in the study, only seven were retarded, and it is likely that those seven also suffered from psychotic disorders. Along with its analysis of NDA files, the FDA also provided a list of citations to published articles : however, one did not involve phenothiazines, two did not involve the mentally retarded, three failed to meet at least four of the six minimal criteria for a controlled study, one was not published, one was not available from the National Medical Library and one was inconclusive.

My summary:

Regulatory failure and unethical psychiatric diagnosis and treatment standards are the two main reasons subsequent investigations have been required; these failures have propelled a criminal enterprise wherein illegal marketing and off label drugging have continued unabated, and have actually flourished into a multi-billion dollar criminal enterprise. The American people are being defrauded in order to pay for ineffective, dangerous treatments that are prescribed to poor children on Medicaid who are vulnerable due to poverty, particularly children in the custody of the state through no fault of their own, men  and women serving in the Military, and elderly citizens in long-term care facilities, are three marginalized groups that are targeted by the illegal marketers working for pharma. The regulatory failure allows rampant fraud to continue unabated. The illegal marketing and indiscriminate off label use of psychotropic drugs is a marketing scheme supported by fraudulent claims that psychotropic drugs "medically treat" undesirable behaviors and emotional difficulties effectively, downplaying the serious risks of disability, and death---it is fraud. 

The fact that this medical malfeasance and criminal fraud appears to be helpful to some psychiatric patients; or at least is not obviously detrimental to every single one, is not significant when considered in context. When one considers that we do not even try to keep track of the number of patients who are harmed by adverse effects of FDA approved drugs, the number of patients who are disabled from the adverse effects FDA-approved drugs; and how many die from FDA-approved drugs used as prescribed. The fact that psychiatry it is not harmful to every patient is not a sufficient justification to continue using an unethical, fraudulent Standard of Care. It is very telling that the American Psychiatric Association and American Academy of Child and Adolescent Psychiatry continue to vehemently defend what clearly are unethical and criminally negligent standards of practice. Consensus and excuses, i.e. it's all we have; are no substitute for the empirical EVIDENCE that is theoretically required to validate ethical medical standards of practice.  

In psychiatry, consensus is substituted for medical science, and lame excuses are proffered to justify deceit and other unethical and coercive behaviors that are endemic to psychiatric practice. There is no ethical substitute for empirical evidence, there is no room for deceit or corrupt data in the development of any medical Standards of Care. Psychiatry has exploited psychiatric patients and has relied upon the general public's unearned, unwarranted trust and respect that historically has been freely granted to medical professionals. Psychiatry has exploited the presumption that trust and respect of medical professionals is warranted and based upon a presumption that medical professionals have ethical integrity; psychiatry used this erroneous presumption as a shield while it  distorted the truth about what is and is not known about psychiatric diagnoses and treatments, and abused it's power and authority to effectively quell dissent from psychiatrists who questioned the methods used and the corrupt data. The hierarchy of the APA and AACAP have both been known to attempt to discredit ethical professionals who refute the methods used and the conclusions reached in corrupt research, and/or object to the deceit and the coercive methods used in standard practice; particularly those professionals who successfully treat patients without resorting to abusing their authority and rebuke the coercive methods of control. Psychiatry has wielded it's authority over patients like a tyrannical abusive parent and abuses psychiatric authority to effectively (de)voice patients who are harmed by it's abusive methods and dangerous treatments.  Well founded complaints of abuse, torture and trauma are minimized or dismissed as "crazy talk." 

A current example of the psychiatric profession's pathological avoidance of the truth, is the outright lie that psychiatry used for decades after it was disproved as a hypothetical cause of depression. The story that depression is or may be caused by a chemical imbalance was only a metaphor; some psychiatrists have said. When this "metaphor" was effectively demonstrated to have no basis in reality, unapologetic psychiatrists then claimed that psychiatrists had never believed depression was caused by a chemical imbalance; stating that the story was simply a harmless metaphorical explanation told to patients in order to help them understand the medical nature of their diagnosis!? This lame excuse is yet another lie. The reason patients were told this "metaphor" is in the hope that if patients believed their diagnosis was an actual medical condition, this belief would convince them of the necessity of being treatment compliant. It is and was always a means to manipulate patients; to coerce compliance with psychiatric treatment. A metaphor used to perpetrate fraud. 

What is truly horrifying is that this metaphor has become an urban legend; it is accepted as a medical fact by the uninformed who believe it is based on genuine ethical medical finding. It is considered "common knowledge" by the mainstream advocacy groups who with the help of psychiatry, continues to (mis)inform the general public using this metaphor as if it was not discredited. In truth, it is a metaphor used with insignificant variations explain the cause of virtually every psychiatric diagnosis... The purpose is not now, and never was, to enable a patient to understand anything; the purpose is and always was to deceive, to convince a patient to accept  psychiatric authority, and to ensure a patient's compliance with psychiatric treatment. The primary purpose for the "metaphor" was to manipulate people's behavior and instill the belief that their symptoms meant they had a "medical disease" or a genetic defect that required medical treatment.  Like all effective propaganda, the fact the metaphor is demonstrably false and that it has been discredited, does not meant it can't still be used quite successfully to deceive patients and parents. 

Metaphor is used as evidence in Courts of Law to deprive psychiatric patients of their liberty. The diagnosis equals medical disease metaphor is the evidence proffered when Involuntary Treatment petitions are filed for Court Orders to deprive people of their liberty, and compel forced psychiatric treatment. With the advent of community treatment orders, the deprivation can be a life sentence... 

Currently, just like the testimony offered in Senate Hearings in 1975, which was specific to the off label use of neuroleptic and other psychotropic drugs to "treat" undesirable behaviors of intellectually disabled children, psychiatric professionals continue to claim to be providing effective medical treatment to children with behavioral problems. The evidence does not support this claim, since the evidence clearly demonstrates that the drugs used are not safe, the drugs have significant risks and even for the children the drugs seems to help, there is little to no understanding of how or why the drugs "work" for a minority of patients, but do not help others...

What is horrifyingly clear is that a massive criminal enterprise is harming the most vulnerable members of society and American's hard-earned tax dollars are paying for it. The pharmaceutical industry's corrupt marketing coupled with psychiatric fraud is decimating the social service safety net. The exact same issues of illegal marketing, off label prescribing and drug safety have been repeatedly investigated, Senate Hearings have been held with credible testimony offered outlining the same underlying deficits which have enabled illegal marketing, fraudulent claims of safety and effectiveness of psychiatric treatment, and describing the abuse of authority endemic in psychiatry. How can it be ethical or justifiable to substitute consensus for empirical evidence when developing diagnostic criteria or adopting treatment standards used in clinical practice? Psychiatry effectively standardized medical negligence of psychiatric patients, by exaggerating the safety of the drugs while denying the harm the drugs caused. Even worse, the iatrogenic injuries patients sustained were attributed to the original psychiatric diagnosis; or attributed to an emergent co-occurring psychiatric diagnosis... In real world clinical practice, iatrogenic injury, iatrogenic disability and iatrogenic fatalities ("natural" death) are common, acceptable outcomes of "successful treatment." 

Transcripts from the Senate Hearings held in 1975

comic found at gocomics.com
Ethic Eze Ad from Bonker's Institute 

MindFreedom International endorses petition asking the governor of Minnesota, Mark Dayton, to investigate research misconduct!

Dan Markingson and his mother, Mary Weiss
photo via MotherJones

via MindFreedom International:

Forced experimentation on psychiatrically labeled people – think it can’t happen here in the US?  Sadly, evidence indicates it has happened, and that it played a part in at least one death.   MindFreedom International is now endorsing a petition, asking the governor of Minnesota, Mark Dayton, to investigate!

The petition concerns the case of Dan Markingson, a young man labeled and involuntarily committed, who was coerced into an industry-sponsored antipsychotic study at the University of Minnesota in 2003.  A “stay of commitment” order compelled him to obey the recommendations of his psychiatrist, who was conducting the antipsychotic study; his mother attempted to speak up for him, warning that he was doing poorly in the study and was in danger of killing himself, but University of Minnesota researchers ignored her warnings.  On May 8, 2004, Markingson committed suicide. 

Although the case has been highly controversial since it became public in 2008, University of Minnesota officials have repeatedly claimed that the university bears no responsibility for Markingson’s death.  A lawsuit against the university was dismissed on grounds of “sovereign immunity. “  Afterwards, attorneys for the university filed an action against Dan’s mother demanding payment of $57,000 in legal costs.

 Seriously, the university filed a legal action against the mother, rather than look into what went wrong!  They have continued to deny responsibility despite the fact that in 2010, AstraZeneca, the sponsor of the study in which Dan died, settled federal fraud charges for $520 million, and a University of Minnesota psychiatrist appeared to be involved.  Last year, the Minnesota Board of Social Work found serious wrongdoing by the study coordinator for the research study in which Dan died.  It is possible that other research subjects have died or suffered serious injuries, or that they have been mistreated in other ways.

After many unsuccessful attempts to have the case investigated by an external research oversight body, Dan’s mother Mary Weiss and her friend, Mike Howard, have petitioned the governor to appoint an external panel to look into the death and other possible research misconduct in the Department of Psychiatry.   Early supporters of the petition include James Gottstein, the director of PsychRights; Marcia Angell, Arnold Relman and Jerome Kassirer, all former editors of New England Journal of Medicine; Michael Carome of Public Citizen and a former official with the federal Office of Research Protection; and Susan Reverby, the historian who uncovered the US-led syphilis experiments in Guatemala, which led to a presidential apology in 2010. 
The petition has also been signed by over 150 experts in medical ethics, law and health professions. 

Sign the petition at this link:
https://www.change.org/petitions/governor-mark-dayton-of-minnesota-investigate-psychiatric-research-misconduct-at-the-university-of-minnesota-2

To take further action in support for the petition, contact:
Eric Kaler
President, University of Minnesota
202 Morrill Hall 100 Church Street S.E. University of Minnesota ?Minneapolis, MN 554
Email: ekaler@umn.edu
Phone: 612-626-1616 Fax: 612-625-3875

Mark Dayton
Office of the Governor 130 State Capitol 75 Rev. Dr. Martin Luther King Jr. Blvd. ?St. Paul, MN 55155 
Telephone: 651-201-3400 Toll Free: 800-657-3717 
Email: mark.dayton@state.mn.us

For more information on the controversy:
Carl Elliott, “Making a Killing,” Mother Jones
http://www.scribd.com/doc/36883035/Making-a-Killing-by-Carl-Elliott

For more information on MindFreedom’s role in stopping involuntary electroconvulsive therapy on Ray Sandford, a Minnesota resident, see  www.mindfreedom.org/shield/ray-sandford

See also:
Jeremy Olson and Paul Tosto, “Dan Markingson had Delusions,” St. Paul Pioneer Press. http://www.twincities.com/ci_9292549


Andy Mannix, “Charles Schulz under Scrutiny for Seroquel Study Suicide,” City Pages, http://www.citypages.com/2011-02-02/news/charles-schulz-under-scrutiny-for-seroquel-study-suicide/


Media contact for petition: Carl Elliott, ellio023@gmail.com

Almost 2 million Americans are addicted to prescription opiates; addiction is not rare

Washington Post

There is no justification for corrupting the medical evidence base, 

undermining the ethical integrity of the medical profession, 

and causing the deaths of countless patients.

There are only excuses like this one:

“Because the primary goal was to destigmatize [opioids], 

we often left evidence behind." Dr. Russell Portenoy

The primary goal of medicine is to ethically treat patients, 
using sound medical judgement.  

Sound judgement requires careful consideration of all the available evidence. 

via The Alliance for Human Research Protection:

Rising Painkiller Addiction Shows Damage From Drugmakers’ Role in Shaping Medical Opinion

Tuesday, 01 January 2013
“You could say these marketing tactics are merely concerning. But I think of them as satanic. What the data are telling us is that these drugs are ruining people’s lives,” said Phillip Prior, MD

"Below is the latest in the Washington Post series--Can Medical Research be Trusted? its focus is the continued rise in painkiller addiction and the decisive role played by corrupt pharmaceutical marketing practices.

"Of note, more than a decade ago, in 2002, the US Drug Enforcement Administration (DEA) reviewed medical examiners' toxicology reports from 32 states. The DEA reported that OxyContin was involved in 464 overdose deaths, few included alcohol consumption.

"But, over much of the past decade, the official word on OxyContin was that it rarely posed problems of addiction for patients. The label on the drug, which was approved by the FDA, said the risks of addiction were “reported to be small.”The New England Journal of Medicine, the nation’s premier medical publication, informed readers that studies indicated that such painkillers pose “a minimal risk of addiction.” Another important journal study, which the manufacturer of OxyContin reprinted 10,000 times, indicated that in a trial of arthritis patients, only a handful showed withdrawal symptoms.

"Those reassuring claims, which became part of a scientific consensus, have been quietly dropped or called into question in recent years, as many in the medical profession rediscovered the destructive power of opiates. But the damage arising from those misconceptions may have been vast.

"The nation is confronting an ongoing epidemic of addiction to prescription painkillers — more widespread than cocaine or heroin — that has left nearly 2 million in its grip, according to federal statistics.

“Around here, we call it ‘pharmageddon,’ ” said Lisa Roberts, the public health nurse for the town, whose primary job is to reduce the fatalities associated with drug use. “This has been absolutely devastating to Appalachia. From what we’ve seen, the risks of addiction were tremendous.”

· “It turns out that the doctors didn’t know what they were talking about,” said Barbara Howard, whose daughter Leslie, a home-care nurse, died of an overdose in 2009 in this small Appalachian town devastated by the epidemic. She had developed a habit after knee surgery. She left behind a 9-year-old son.

· “Leslie trusted the doctors. We thought the doctors knew what was best. But they didn’t. We — and lots of the other victims — had no warning.”

“You could say these marketing tactics are merely concerning. But I think of them as satanic. What the data are telling us is that these drugs are ruining people’s lives,” said Phillip Prior, MD

"To refine its policy on opioids, the FDA convened a key meeting in 2002 and invited 10 outside experts for advice. Five of them reported having served as speakers or investigators for Purdue. Three others reported working as speakers for or as advisers and consultants to other pharmaceutical companies.

"One of those FDA advisers, Dr. Russell Portenoy, who was then the chair of the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York, has since expressed regret for his evangelism on behalf of opioids.

"He was “trying to create a narrative so that the primary care audience would . . . feel more comfortable about opioids,” Portenoy said in a 2010 interview, “Because the primary goal was to destigmatize [opioids], we often left evidence behind. (emphasis mine)

“To the extent that some of the adverse outcomes now are as bad as they have become in terms of endemic occurrences of addiction and unintentional overdose deaths, it’s quite scary to think about how the growth in that prescribing driven by people like me led in part to that occurring.”

"In 2003, Purdue Pharmaceuticals, the manufacturer of OxiContin--whose sales reached $1.3 billion--had the gall to sponsor advertisements warning about prescription drug abuse!

Vera Sharav here

By Peter Whoriskey,

Rising painkiller addiction shows damage from drugmakers’ role in shaping medical opinion

  December 30, 2012    

"Portsmouth, Ohio — Over much of the past decade, the official word on OxyContin was that it rarely posed problems of addiction for patients.

"The label on the drug, which was approved by the FDA, said the risks of addiction were “reported to be small.”

"The New England Journal of Medicine, the nation’s premier medical publication, informed readers that studies indicated that such painkillers pose “a minimal risk of addiction.”

"Another important journal study, which the manufacturer of OxyContin reprinted 10,000 times, indicated that in a trial of arthritis patients, only a handful showed withdrawal symptoms.

"Those reassuring claims, which became part of a scientific consensus, have been quietly dropped or called into question in recent years, as many in the medical profession rediscovered the destructive power of opiates. But the damage arising from those misconceptions may have been vast. 

"The nation is confronting an ongoing epidemic of addiction to prescription painkillers — more widespread than cocaine or heroin — that has left nearly 2 million in its grip, according to federal statistics." read here

Parents: Please Educate Yourselves About Psychiatric Drugs

What is the Scientific Basis of Psychiatric Treatment?

PLEASE EDUCATE YOURSELF ABOUT PSYCHIATRIC DRUGS

According to the Wall Street Journal 6.5 million children and youth 19 and under given neuroleptic drugs, called 'antipsychotics' in 2009. I wonder how many of these children experienced a life threatening emergency, became disabled, or died as a result? The lack of honesty is seemingly endemic to psychiatric research and 'peer-reviewed' professional journals, psychiatric textbooks and Continuing Medical Education programs. Since this corrupted "Evidence Base" is what 'mental health treatment' is based upon, checking facts about the risks associated with taking psychiatric drugs is not only advisable' it's a necessity. The Physicians Desk Reference,  The Alliance for Human Research Protection, and RxISK.org are some of the sources available online.

The reality is used as directed, neuroleptics, called 'antipsychotic,' drugs, can cause illness, disability, brain damage and early and/or sudden death. The fact that these very real adverse effects are NOT being shared with people prior to the drugs being prescribed to them, is obviously unethical; it is also criminal. When these teratogenic drugs are prescribed to children, (usually "off-label") parents are often not even informed of the very real life-altering conditions that are drug-induced, commonly occur, even though these adverse effects can be disabling, and even fatal. neuropleptic drugs are commonly prescribed "off label" an innocuous term that belies the fact that using the drugs in this manner is in fact, "experimental use" of very dangerous drugs. It is human experimentation; the fact that it is being done in standard clinical practice,is evidence that psychiatry is not in fact "evidence-based." There isn't sufficient empirical evidence to support using neuroleptic drugs "off label" for any condition or behavior any child has; in reality, the empirical evidence is not robust enough to consider neuroleptic drugs as a first-line treatment for childhood-onset schizophrenia.

Parents are not being told that there is often little, to no evidence to support many prescriptions for psychotropic drugs; nor are they given accurate information about the direct adverse effects of the psychiatric drugs prescribed to their children. Not being given the facts, undermines a parent's ability to make informed decisions in their child's best interest. In reality, it often means that parents are not being given the information necessary to determine whether or not their child should take the drugs being prescribed. This ethical failure is not necessarily accidental or even an intentional oversight; it is more often due to the corrupted data that is contained in the evidence base. The average mental health professional who relies on the articles in peer reviewed journals cannot help but be misinformed and consequently provides patients and parents with biased, or otherwise inaccurate information about the drugs they recommend.

Marcia Angell, MD, former Editor in Chief of The New England Journal of Medicine, reviewed three important books that examine corporate-academic liaisons that have corrupted the integrity of American medicine. In her review titled, Drug Companies and Doctors: A Story of Corruption, she said of Jeffrey Biederman: "Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose."

"Between 2000 and 2007, Dr. Biederman was paid at least $1.6 million in consulting and speakers fees to promote the use of toxic drugs--in particular, antipsychotics--for children, for whom they had not been approved. The short-term harm produced by these drugs in children is documented--including obesity, new onset diabetes, and heart damage. The effect of long-term use of these drugs by children is still mostly unknown. However, the capacity for harm in particular for children's immature, still developing brains is immense...

"In spite of corruption, fraud, and invalidated research and unethical conduct; the work of Biederman, Nemeroff, and Schatzberg, (among others) remains intact in "peer-reviewed" journals and textbooks; and is used in clinical practice across the country. According to Dr. Angell, "Legally, physicians may use drugs that have already been approved for a particular purpose for any other purpose they choose, but such use should be based on good published scientific evidence." (emphasis mine)

I have questions for all psychiatric and mental health professionals, and so should any parent who seeks mental health care for their child. Here are a few of mine:

What is the scientific basis for using dangerous neuroleptic drugs, or "antipsychotics" for any diagnosis?

What is the scientific basis for using neuroleptics 'off-label,' i.e. experimentally, on children?

What is the scientific basis for coerced, i.e. forced or "assisted" treatment of any one?

Is dishonesty and abuse of power, i.e. the use of coercion, misleading patients/parents about the nature of a psychiatric diagnosis by stating it is a disease, 'chemical imbalance' or 'neurobiological' condition acceptable, or even ethical?

What is Informed Consent?

Is Informed Consent possible when professionals rely upon corrupted data and the biased articles in "peer-reviewed" professional journals that exaggerate the benefits and minimize the risks?

Informed Consent

Informed consent discussions should include disclosing the fact that all psychiatric diagnoses are based on subjective observation and opinion. The consent discussion should also include informing people of the life-altering risks to one's liberty interests once a psychiatric diagnosis is attached. The risks of the proposed treatment; and the potential benefit of the recommended treatment need to be understood. An ethical Informed Consent process cannot include manipulating the patient or family member in an effort to convince them to consent to treatment. Telling people that a psychiatric diagnosis is caused by an unidentified "disease" when no disease has been diagnosed or identified in the diagnostic process; it is dishonest and no professional should make a fraudulent claim to coerce the patient or a parent into believing a diagnosis requires "medical treatment." To use these tactics is to commit fraud, not provide ethical medical care. Making fraudulent claims is unethical, no medical professional should mislead and/or outright lie to a patient or their family members in an attempt to alter behavior to gain cooperation or treatment compliance. It is entirely unethical to coerce and manipulate a person while simultaneously limiting or inhibiting the person's ability to exercise their own free will, or in an attempt to alter their decision. Informed Consent can only be ethically obtained when valid accurate information about the diagnosis, and the recommended treatment, is understood by the person giving consent.  Consent is guided by a patient's self-determined morals and values and serves the self-identified best interests of the patient; informed consent must be freely-given.

Informed Consent requires honest forthright communication. It is an ongoing conversation about the risks vs. the benefits. Informed Consent is a decision made by the patient, or the guardian of the patient. All relevant information is (theoretically) provided by the prescribing professional. The discussion should include whether the drug prescribed is being prescribed for an FDA approved use, or is being prescribed experimentally. It is inaccurate and misleading to refer to these prescriptions as simply being "off-label."  I say this because "off-label" use is common in medicine, but it is still needs to be supported with evidence that using a drug "off-label" is safe and effective for the person and the condition for which it is being prescribed.  Rarely do "off-label" prescriptions have such evidence to support them. since these types of prescriptions are not supported with empirical evidence of either the safety or effectiveness and the potential risks include dependence, iatrogenic disability and death.

Alternative treatments, whether available or not, and no treatment, should be part of the consent dialogue. A professional should be supportive of the patient and/or parent who needs time to digest the information shared, and supportive if they wish to consult anyone they choose before making a decision.  These are requirements in the American Medical Association's Ethical Guidelines for Informed Consent.

The choice to take or not take psychiatric drug/s as prescribed must be made freely, voluntarily, and without coercion; and without fear it will be disrespected or under the threat of filing a CPS report alleging medical neglect. Removal of children into foster care Under Color of Law by mental health professionals and child welfare workers has become an ever-present threat for parents in the United States who do not give consent for using dangerous teratogenic drugs to "treat" the emotional and behavioral symptoms their children have...

portions of this post were originally used in 'What is the Scientific Basis of Psychiatric Treatment?' 12-30-10

Stating depression is due to a 'chemical imbalance' is no 'metaphor'

On January 19, 2012 60 minutes aired a program on the SSRI antidepressants.  CBS featured the work of Irving Kirsch, whose work demonstrated effectively that in clinical trials, including the trials used to obtain FDA approval, the SSRI 'antidepressants' were not statistically more effective than placebo. Jonathan Leo and Jeffrey Lacasse in their blog on the Mad in America website, 'Rethinking the Broken Brain,' write about how this "dirty little secret" received a public airing (so to speak) and was presented as 'news' e.g. new information, even though it has been known for years.  It is not 'news,' nor is it recently discovered information about these drugs.  Kirsch's conclusions are drawn from a meta-analysis of the data submitted to the FDA to gain the drugs approval, as well as after approval clinical trials.  

This 'dirty little secret' was known to the FDA, a Federal Regulatory Agency all along.  It is obvious that the FDA has acted in concert with the pharmaceutical industry, and buried this relevant information.  Also buried was Traci Johnson, a 19-year-old who committed suicide while in a drug trial. The FDA attempted to rationalize their complicity in hiding the facts of her death, as a legal duty to protect Eli Lilly's, "Trade Secrets."  This excuse is insulting to one's intelligence. FDA employees have been working as willing co-conspirators by approving drugs on insufficient evidence.  The FDA has in effect and in fact been actively participating and passively allowing illegal activity throughout the entire drug approval and marketing process.  Unethical and illegally  conducted pharmaceutical drug trials, trials structured and conducted with the sole purpose of expanding the market for a drug are then reported in a biased   manner in professional literature, and at conferences all of which is part of the pharmaceutical  marketing plan for the drug.  It is criminal negligence to cover up adverse events, including fatalities.  The FDA purposely covered up fatalities drugs have caused in the trials conducted to gain FDA approval.   The FDA purposely set up a system that is not tracking adverse events effectively after drugs gain approval.  The FDA claims the reason it covered up fatalities in trials prior to a drug's approval is due diligence of duty; leaving no doubt, the FDA is conducted as if it's primary duty is to protect the drug industry.

The drug was not FDA approved when 

Traci Johnson killed herself.

The FDA approved Cymbalta to treat depression in August 2004

Eli Lilly conducted the clinical trials for duloxetine, which they called, Cymbalta, for use as an antidepressant; and Yentreve, for treating urinary incontinence simultaneously, with Cymbalta receiving FDA approval first.

Jeanne Lenzer reports via Slate Magazine: 

"By the end of that year, Cymbalta sales topped $61.3 million.  In January 2005, as Cymbalta sales climbed to $106.8 million for the first quarter, Lilly announced that it was withdrawing its application for Yentreve.  Then it cited the trade-secret rule in refusing to disclose why the drug did not win approval." 

The so-called, "Trade Secret" is dirty, but is no little secret; just dirty rotten. 

More than a dozen bodies were buried in order to enable 

Eli Lilly to claim Cymbalta is safer and more efficacious than it is...

more from Slate:

"Over four months beginning in January, I filed several Freedom of Information Act requests on behalf of the Independent on Sunday, a British newspaper, for all safety data related to Cymbalta and Yentreve. I received a database that included 41 deaths and 13 suicides among patients taking Cymbalta. Missing from the database was any record of Johnson, or at least four other volunteers known to have committed suicide while taking Cymbalta for depression." read here

This is the legal definition of fraud:

"A false representation of a matter of fact—whether by words or by conduct, by false or misleading allegations, or by concealment of what should have been disclosed—that deceives and is intended to deceive another so that the individual will act upon it to her or his legal injury."

"Fraud is commonly understood as dishonesty calculated for advantage. A person who is dishonest may be called a fraud. In the U.S. legal system, fraud is a specific offense with certain features."

The certain required features:

"Fraud must be proved by showing that the defendant's actions involved five separate elements: (1) a false statement of a material fact,(2) knowledge on the part of the defendant that the statement is untrue, (3) intent on the part of the defendant to deceive the alleged victim, (4) justifiable reliance by the alleged victim on the statement, and (5) injury to the alleged victim as a result." via The Free Dictionary

 NPR had a program about another 'secret' the FDA, the American Psychiatric Association, and the American Academy of Child and Adolescent Psychiatry have been keeping for the pharmaceutical industry: the 'serotonin metaphor.'   This supposed 'metaphor' is referring to the claim that depression is caused by a serotonin imbalance...The claim that depression is caused by a chemical imbalance of any kind is not based on any facts, it is a claim made so patients believe that depression is a medical condition caused by a chemical imbalance, which requires antidepressant drugs to 'correct the imbalance."  It is told to gain 'treatment compliance.'

The definition of metaphor:

A figure of speech in which an implied comparison is made between two unlike things that actually have something in common. Adjective: metaphorical.  A metaphor expresses the unfamiliar in terms of the familiar. ex. "Love is a rose"

via Mad in America Rethinking the Broken Brain: 

"Revising the History of the Serotonin Theory of Depression?" a couple of excerpts:

"What if research has indicated for decades that the serotonin theory is false, yet psychiatrists told their patients the serotonin story anyway? What would this mean?"

“By 1970…[George] Ashcroft had concluded that, whatever was wrong in depression, it was not lowered serotonin.” [D. Healy, Let Them Eat Prozac] 

“Although it is often stated with great confidence that depressed people have a serotonin or norepinephrine deficiency, the evidence actually contradicts these claims.” [Neuroscientist Elliot Valenstein, 1998, in Blaming the Brain]

“In truth, the  "chemical imbalance" notion was always a kind of urban legend- never a theory seriously propounded by well-informed psychiatrists.” Ronald Pies, M.D., Editor of Psychiatric Times, in 2011 

read here

It has been known for decades depression is not caused by a chemical   imbalance of serotonin, or any other neurotransmitter.  Unless the word 'metaphor' is a euphemism for telling a lie in order to successfully convince people to take their "prescribed treatment," e.g. manipulate a patient's beliefs about a psychiatric diagnosis, with the intent of altering their behavior to ensure 'treatment compliance.'   This so-called 'metaphor' has been effectively used as a tool in perpetrating consumer medical fraud.   Stating depression is due to a 'chemical imbalance'  is no 'metaphor.'

via Phil Lawrence, NUMB a documentary director on youtube:

Vera Sharav speaking at a Press Conference prior to the 2006 FDA Advisory Committee Public Hearing on the connection between antidepressants and suicidal thoughts and actions. The press conference was put together by the family of Woody Witczak.

via The Alliance for Human Research Protection:

Vera Hassner Sharav, M.L.S.

Vera Sharav, a professional law librarian turned public advocate for human rights, is the founder and president of the Alliance for Human Research Protection (AHRP) which serves as an information resource, a public interest watchdog, and a catalyst for public debate whose goal is to unlock the walls of secrecy in biomedical research and to bring accountability to that endeavor.

She has earned the respect and admiration of a distinguished network of physicians and scientists including those who have agreed to serve on the Medico-Scientific Advisory Committee for a publicity campaign aimed at providing credible information to consumers about the undisclosed risks of widely and inappropriately prescribed psychotropic drugs whose hidden hazards pose severe, irreparable risks of harm.

Ms. Sharav has developed a database to track ethical violations in research and failure to disclose drug hazards. Her advocacy efforts include: suspension of EPA pesticide experiment (CHEERS) on children (2005); federal investigations on the use of children in foster care in experimental AIDS drug and vaccine trials (2004); suspension of smallpox vaccine on children (2002); suspension of "violence prediction" experiment exposing 6-11 year old NYC boys to fenfluramine (1998); organized testimonies by victims of unethical research before the National Bioethics Advisory Committee (1997). These testimonies led to a prize-winning series in the Boston Globe, "Doing Harm: Research on the Mentally Ill" (1998), the shut down of 29 clinical trials at the National Institute of Mental Health (1999), culminating in the prize-winning book by Robert Whitaker, Mad in America (2001).

Mrs. Sharav served on the Children’s Workgroup of the National Human Research Advisory Committee (2001-2002); she has testified before national policy advisory panels including: the Institute of Medicine (against prisoner experiments (2005); against human pesticide experiments (2002); FDA hearings on antidepressants and the risk of suicide (2004 and 2006), the National Bioethics Advisory Committee (1997), military ethics forums and academic forums, and consumer advocacy forums (2006). Among her recent publications: Screening for Mental Illness: The Merger of Eugenics and the Drug Industry, Ethical Human Psychology and Psychiatry (2005); Conflicts of Interest in Biomedical Research Harm Children With and Without Disabilities,"Journal of Disability Policy Studies (2004); "The Impact of FDAMA on the recruitment of children for research," EHPP (2003); "Children in Clinical Research: A Conflict of Moral Values," American Journal of Bioethics (2003); The ethics of conducting psychosis-inducing experiments," Accountability in Research (1999).

via the FDA: Guidance Drug Safety Information 
FDA’s Communication to the Public an excerpt:

"FDA recognizes that some sponsors may consider making promotional comparisons between their drugs and drugs for which emerging drug safety information has been provided by FDA.  We remind sponsors that all safety and effectiveness claims made in prescription drug promotion, (25) including claims based on Government materials available from the Index to Drug-Specific Information, must be supported by substantial evidence or substantial clinical experience and must not be otherwise false or misleading (21 U.S.C. 355 and 352; 21 CFR 202.1(e))" (emphasis mine) read here

snake oil image from businesspundit.com