Psychiatric Drug Facts via :

“Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems… Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision.” Dr. Peter Breggin

Sep 22, 2011

Medicaid fraud and real world outcomes

Isaac at 17

portions of this post was originally published March 29, 2011 with the title, "Is medicaid fraud endorsed by federal agencies?"

Medicaid Fraud must be endorsed by the Centers for Medicaid; it is the only logical explanation for the rampant fraud resulting from the psychiatric drugging of children being paid for by Medicaid. (even drugs not approved for pediatric use) Drugs for "physical ailments" will not be filled by a pharmacy unless they are "approved" by Medicaid when one is on Medicaid; unless you agree before the prescription is filled to pay cash. Massive Medicaid fraud has caused publicly funded heath care costs to spiral out of control.

The Pharmaceutical Companies have been fined heavily, and paid settlements to multiple States. But what about the doctors who wrote the prescriptions and the pharmacies that filled the prescriptions for unapproved drugs? What about the children who were harmed, or died because of this fraud? It is appears that decisions were made by administrators inside Centers for Medicaid to allow this massive fraud. Why else would millions of claims for psychiatric drugs not approved for pediatric use be paid, in spite of Medicaid regulations that prohibit payment of them? The fraud has been going on for decades. My son is a victim of this massive fraud and corruption.

Ten years before there was any "approved" pediatric use for Johnson and Johnson's 'Risperdal,' it was prescribed to my son to treat aggression, treatment of aggression is still not a clinically validated or approved use of this neuroleptic drug fifteen years later. Medicaid paid for the Risperdal, ongoing for years, paid fraudulent claims filed by the State of Washington's Medicaid program, for drugs prescribed to my son, "off-label." When a drug for a severe grass allergy was needed--one time--being an "unapproved" drug according to the Medicaid program, I had to pay cash to fill the prescription. Why is there an different (unwritten) standard for psychiatric drugs? What is the point of the FDA and CMS having Regulations at all, if there is no real effort to be accountable?

The betrayal I feel for this series of events which have caused my son to be altered cognitively and physically; effectively disabling him, is indescribable.

The rampant fraud and corruption have in effect, if not in fact, been endorsed by both of these regulatory agencies, and permitted by the FDA, who has also abdicated it's primary responsibility to inform and protect the American people, from known risks of FDA approved drugs. Fraud continues unabated; and will continue with weak efforts of enforcement of the Consumer Protection Laws which are also being virtually ignored in the approval and marketing of FDA approved drugs. Until and unless the American people demand that our elected representatives and those who are paid public servants start working for the people who elect and pay them, instead of the "special interest" groups who are in this case, running a vast criminal enterprise which is, in reality, defrauding the people through Medicaid, Medicare, and Tri-care. Psychiatric drug treatment algorithms which are known to be ineffective; and worse--are known to be potentially fatal; are still Standard Practice, and psychiatry has the Courts and the police acting as partners; which requires these Officers of the Court to abdicate their duty to preserve and protect the Constitution of the United States of America.

As bad as it is, it is not the fraud and corruption of the drug industry and the psychiatric researchers who aid and abet them, that most angers me. What most angers me is these Federal Agency's regulatory failures are responsible for the widespread use of dangerous ineffective drugs on children, traumatized Veterans and the elderly; without any accountability for the disability or the deaths the drugs have caused; nor is there any attempt to prevent more deaths and disability from being caused to more vulnerable American children, elderly or traumatized Veterans. The FDA is not protecting the American people. Once a drug is approved for ANY use; the drug can be prescribed for any purpose to any population. The American people are still largely unaware that drugs can be given to their children without ever having been tested as safe or effective for children.

Medicaid Guidelines are to prevent costs for "unapproved" treatments including drugs, from being paid; theoretically, it is like insurance. If it isn't covered, it isn't paid for. This system works pretty well, with an obvious unexplained and costly anomaly: drugs prescribed for psychiatric diagnoses are paid for, even when they are not supposed to be. Medicaid regulations are inexplicably ignored and prescriptions for psychiatric drugs, even drugs not safety tested or FDA approved for the reason prescribed, are paid for; even though the prescriptions are theoretically, not a covered expense. All of this is illegal, has greatly enriched the drug companies, and worst of all, has led to children being disabled or dying from known (to the FDA and the drug companies) deleterious effects of psychiatric drugs. Parents are not even told of the risks: including risks of permanent iatrogenic harm, disability and death. The FDA claims these risks are "trade secrets;" does not require prescribers to report adverse events--even death, to the FDA Adverse Events Reporting System.

I want to know why the Department of Justice is not prosecuting the crimes committed against our Nation's children? Why have there been no Federal charges against doctors, psychiatric researchers, or pharmacists for lying about the research, exaggerating benefits while minimizing risks of the drugs--then committing further fraud by filing false Medicaid, Medicare and Tricare claims? Why is no effective means to stop the fraud being implemented? Why are the American People still doning business with these corporate thugs? Why are false claims still being paid for?

via PsychRights:

"In a surprising action, however, on March 7th, the Department of Justice actively moved to protect alleged defrauding defendants at Steps 2 & 3 by asking the judge to dismiss the ex rel Nicholson case for what appears to be disingenuous reasons."

"In light of this, PsychRights asked Eric Pruitt, the Assistant United States Attorney who filed the motion to dismiss on behalf of the United States Government, the following questions:

1. Why shouldn't it be concluded the Department of Justice and CMS are protecting prescribers and
pharmacies for their participation in this continuing massive fraudulent scheme?

2. Does CMS take the position that prescriptions not for a medically accepted indication are covered under Medicaid?

3. Is CMS calling the shots on the Department of Justice's response to the qui tam cases against prescribers and pharmacies for causing and presenting false claims to Medicaid for psychotropic drugs used on children and youth that are not for a medically accepted indication?

4. Do the Department of Justice and CMS consider only the economic point, i.e., the drug companies have deeper pockets, or are they attempting to make an independent judgment that somehow psychiatrists and pharmacists are less culpable for the same fraud?

5. Even if so, why is CMS still paying these false claims on a massive scale?"
Mr. Pruitt declined to answer, saying "We do not comment on pending cases:"

In response, Mr. Gottstein said, "The public is entitled to know the answers to these questions. Obtaining large recoveries from drug companies is an ineffective sanction, because the fraudulent prescribing practices are continuing unabated. It appears the Department of Justice is now actively protecting doctors and pharmacies committing Medicaid Fraud."

Read the press release from PsychRights here.

All due respect to Mr. Pruitt; I am not buying his statement that the failure to answer these questions is due to a policy of not commenting on "pending cases." The questions posed are relevant to what is happening in every single State in the Nation, (Medicaid fraud continues unabated) Mr. Gottstein is right: The American people are entitled to answers! A lame deflection from a Department of Justice employee in response to pertinent questions is not exceptable! Mr. Pruitt you work for the American people and The American people deserve answers not excuses!

In my experience, Medicaid denied payment for drugs not on the Medicaid "approved list" when the drugs were to treat any "physical" illness. The pharmacy would not fill the prescription unless I agreed to pay cash...It is obvious to me there are different standards applied for drugs that are prescribed for psychiatric reasons; they do not need to be "approved" to be paid. This is no accident, or oversight; it is intentional. It is the result of corruption, fraud, spurred by medical and regulatory negligence. If the Department of Justice fails to bring the perpetrators to Justice, it is Government Sanctioned fraud which continues to victimize countless thousands of children; some of whom will become disabled, and some will die as a result. My son is disabled because of harmful psychiatric drugs given to him as a child without Informed Consent, some drugs were not "approved" for pediatric use for any purpose. One of these drugs, is still not approved for use in children---ten years after it was first given my precious son.

via The Injury Lawyer Directory

"The Third Most Dangerous Drug

In 2007, an eight-year study (1998 – 2005) was reported in the American Medical Association’s Archives Internal Medicine. The FDA’s MedWatch data had been analyzed for adverse drug events, meaning drug-triggered deaths, or events resulting in disability or serious medical intervention. There were 467,809 of these events that had been reported to the FDA.

Clozapine was found to have triggered 3,277 deaths, making it the third most dangerous drug being used in the U.S. It was also connected with over 4,300 adverse drug events that led to disability or required serious medical intervention."

What is the purpose of the FDA approval, if it is not to protect our children from harmful drugs? "Off-label" prescriptions are considered "experimental" by the FDA. Doctors and other medical professionals are not required to report adverse events--even fatal outcomes for FDA approved drugs. We have drugs on the market which were approved based on flawed, biased, unethical research, or not any more effective than placebo, according to clinical trial data. Cymbalta was FDA approved after five people--normal controls, without any psychiatric diagnoses, committed suicide in the drug trials.

In the case of neuroleptics and antidepressants, the newest most expensive drugs which are known to be no more effective or safer than older, less expensive drugs, yet are used as "first line" treatments, and here in Washington State are "preferred" by Medicaid, Medicare and Tri-care. The FDA claims it has no duty to inform the public about clinical trial data that is negative. The FDA in fact, seems to protect the drug industry; and not the patients. The failure to require prescribers to report adverse events is an egregious unforgivable error on the FDA's part. By not requiring this critical reporting of adverse events, the FDA protects the drug industry's interests; to the detriment of the American people the FDA was established to protect. It is the American people the FDA works for, yet it is failing to serve the American people's interest, in order to serve the drug industry's corrupt marketing schemes. Adverse event data needs to be collected in order to assess the safety and efficacy of FDA approved drugs in real world practice.

Washington State has received millions from lawsuits against drug companies for fraudulent marketing of psychiatric drugs and yet the primary victims, like my son, have received nothing for the harm done to them. We have failed to responsibly or effectively use the information known about the safety and efficacy of the drugs to formulate public policy, or curb the growing indiscriminate, unethical and unapproved off-label prescribing of expensive drugs which continues to defraud publicly-funded medical benefit programs.

In fact, the data derived from research is being ignored altogether both in formulating pubic policy and passing legislation in Washington State. Specifically, at the same time the results for the TEOSS and CATIE drug trials; the massive fraud and corruption behind the drugs being marketed; and the academic and research fraud behind the psychiatric drug approval process were being reported by National news organizations, NAMI Washington and local affiliate members lobbied the Legislature successfully for changes in the Civil Commitment Laws. This successful effort was orchestrated by people presenting a biased and conflicted perspective who failed to mention the evidence of rampant fraud OR the obvious Conflict of Interest of NAMI members who lobby as NAMI representatives. NAMI's main sources of revenue is the drug industry, and also receives government grants. this to me would definitely call into question the legality of their lobbying activities. The failure to disclose the very obvious Conflict of Interest their financial dependence on the pharmaceutical industry, or that the materials NAMI disseminates are often written by the pharmaceutical industry itself and are biased favorably towards BigPharma's interests. Failure to disclose the Conflict of Interest that it is to have the source of the "information" and the source of the majority of NAMI's revenue is also the primary beneficiary of the fraud; is an enormous betrayal of the public's trust. In this respect, NAMI functions more as an arm of the psychiatric drug marketing departments than as advocates for individuals with psychiatric diagnoses, and their families.

The Evidence Base for psychotropic drugs does not in fact support or validate the "Standard Drug Treatment Algorithms" used in Standard clinical practice. these Standard Practices were all validated by a VOTE, not based on or validated by the empirical data derived from clinical research. This is not scientific or ethical medicine, it is the political process of an oligarchy; pretending to be science-based medical specialty.

Valid scientific information is often excluded by these medical "specialists" who misinform "advocates;" manipulate family members with emotional appeals, and empty promises of "being on the cusp of discovery of a "better treatment" for ""neuro-biological diseases" when in reality, the drugs cause neuro-biological diseases. The disease hypothesis is utilized to gain desperate patients and family members willing participation in marketing of the biomedical psychiatric paradigm of mental health "care." Numerous Conflicts of Interest are minimized, while the scientific principles of ethical medical practice are overlooked.

Biased data, subjective opinions, and anecdotal evidence are used in lieu of valid scientific evidence, as "evidence" in Courts of Law to obtain Court orders for involuntary treatment. More and more people are being Court Ordered to take ineffective and dangerous drugs without their Constitutional Rights being preserved or defended as a result. Diagnosis and treatment methods are validated by a vote and is reliant on fraud, deception, coercion and manipulation of vulnerable people. The entire process is political not medical in nature. Since both the diagnoses and treatment standards are developed using a consensus of subjective opinions in committee, validated by a vote first by the committee, then the membership of the American Psychiatric Association; it is not an ethical, scientific, or medical process; it is a political process.

Current Recommendations for Early Onset Schizophrenia Diagnosis and Treatment is a document put out by the Commission on Youth in the State of Virginia. It relies heavily on Jon McClellan's research, and it reads like he wrote it; although the document does not list an author. This document states there are no evidence-based drug treatments for early on-set schizophrenia in children: because none of the existing neuroleptic (antipsychotic) drugs are efficacious enough to be called Evidence Based treatment for schizophrenia.

Why are we in Washington State strengthening laws which Court Order people to take what are known to be dangerous, life threatening drugs which cause debilitating illnesses and increase the cost of medical care needed by those who by use these drugs? This is harming people and increasing the costs of their care, once they develop the iatrogenic illnesses and metabolic conditions the drugs cause. More importantly, why are drugs which are known to be only marginally effective for a minority of people with symptoms of psychosis or schizophrenia, being forced on people by Court Order?

I am simply a mother who has been lied to and misled by every psychiatrist who has ever treated my son; the fact that some of them were misinformed in their training and by the professional journals they use, is of no comfort to me. I repeatedly insisted I had the right to act on my son's behalf and did not want him to be drugged; it was more than obvious the drugs were causing him grave harm. Jon McClellan told me I had no say. I never signed any consent for any drugs to be given my son---I was told by Jon McClellan my consent was not needed. I had to find out the truth for myself by doing research on my own. The man would not even tell me the risks involved with the drugs he was testing on my son; ultimately, he denied he was using my son in the TEOSS drug trials at all. Whether he was or not, he did not have my consent to do what he did to my son.

I am not, as some may mistakenly assume, "anti-psychiatry" or anti-drug treatment for symptoms of any psychiatric diagnosis. I am however, pro Informed Consent, full disclosure and truth in medicine. I do not believe the practice of "medicine" by psychiatrists and other mental health professionals should have the Police and the Courts working as service providers delivering unwilling patients to mental health practitioners who use deceit, coercion and manipulation of both the facts about the drugs and the diagnoses. It is Standard Treatment to use social control methods implement drug compliance protocols, which is dishonest and unethical. Why is dishonesty even accepted, let alone required, to practice this 'medical specialty'?

All Americans have individual rights which are clearly defined by the Constitution of the United States; as are the means these rights are effectively protected and defended. Any and all loss of liberty must not happen without Individual Rights to Substantive Due Process of Law being protected and defended---Why has this Nation allowed fraud, corruption and sensational emotional sentiment to drive public policy while dismissing relevant scientific evidence and stripping people of the protections which belong to all individuals, according to the preeminent Law of the Land?

Self-appointed advocates and lobbyists who are funded by the pharmaceutical industry, lobby for these public policies, and the passage of the Laws which deprive people of their liberty and risk their health and well being. Most egregious is the fact that these advocates deny that victims exist at all---including parents who have buried their children---Ultimately, some of these efforts result in policies which give less protection to those among us who are in need of care and protection; as a natural consequence resulting from the efforts of advocates who serve most effectively as drug industry lobbyists.

It seems to me that if a person is mentally ill and not able to articulate or understand their rights, or assist in their own defense, we as a society should be more diligent in our duty to preserve and defend their rights; not less. It is immoral and discriminatory to use a person's psychiatric diagnosis as an excuse to deprive them of liberty when they in fact are unable to defend themselves! Such proceedings are devoid of even the appearance of justice; because some or all of the the standards and methods to effectively preserve and defend the individual's Constitutional Rights are absent.

Proper Notice, Proof of Service, Rules of Evidence, Standard Court Procedures, and Effective Assistance of Counsel are required to effectively preserve and protect Individual Rights; anything less, is not acceptable or Constitutional. None of these were evident in the proceedings in which my son was deprived of his dignity, his liberty and the protection and advocacy of both his brother and myself. My son's rights were not in fact preserved or defended as a minor or as an adult here in Washington State---and no investigation has ever occurred. When I have reported these failures to Washington State "authorities" whose duty it is to ensure his rights are effectively preserved and defended, they are ignored or dismissed.

The negative effects of neuroleptic drugs are not "side effects," they are THE effects. Particularly for people the drugs do not effectively treat. If the drugs do not effectively help the person, the deleterious effects are the effects; not "side effects." Neuroleptic drugs are "therapeutic" for 26% of adults and 12% of children who are diagnosed with schizophrenia; which begs the question why are they being touted as "necessary medical treatment" by advocates and psychiatrists, for all people who are diagnosed? This is obviously not a claim which is based on evidence. It is a claim which is contradictory to the evidence. It is a claim that is used to manipulate parents, patients and the general public by misinforming, coercing and manipulating people to enforce a social control strategy. Calling it "necessary medical treatment" does not change the nature of what is actually being done, and it does not justify using deceit, coercion and manipulation of the facts to gain the general public's cooperation in being complicit. How can it be considered a good idea to legally compel a treatment compliance policy with drugs known to be ineffective for the majority of the people who will be subjected to it? Making it legal does not make it right, or the drugs any more effective or any less dangerous; it just makes all people of conscience who do nothing to stop these crimes, complicit in crimes perpetrated against vulnerable people. Those who do not practice according to ethical standards, should not trusted; much less be given license to Court Order our vulnerable citizens.

People of conscience with moral integrity have a sense of honor which compels a duty to our fellow man. Our duty is to protect them, to preserve and defend their dignity and their Human Rights, which were so important that these rights were declared to be inalienable rights by Our Forefathers. Instead we have made it legal to deprive our vulnerable and defenseless citizens based on lies, fraud and widespread corruption; in effect, we are selling them out in support of a vast criminal enterprise; and claiming it is being done "for their own good." Some of the most zealous proponents of Laws which redefine the "seriously mentally ill person's" Individual Rights, rewrite the Law to alter what is considered 'legal testimony' in Courts of Law and further claim to be "Advocates FOR the seriously mentally ill" is it any wonder the mental health system is in shambles, or that it has decimated social service system budgets, destroyed lives, and is NOT helping the majority of people whom it 'serves?' The fact that it is built on deception, fraud and corruption may be why...

1 comment:

Sacha White said...

Amen and AMEN, my dear. INFORMED CONSENT MEANS WE KNOW THE SCORE, SIDE EFFECTS AND DANGERS!!! I am so very grateful to have a PCP that does exactly this for me with each and every drug prescribed and is not afraid to inform me. Thank heavens you are out here advocating for ALL of us that have been repeatedly victimized by a system run by money and could care less about the pain or suffering withstood by the very people they're supposed to be protecting! Keep up the great and awesome blogs!!!!


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