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Showing posts with label Psychiatric Diagnoses. Show all posts
Showing posts with label Psychiatric Diagnoses. Show all posts
May 26, 2013
Apr 11, 2013
Psychiatry, Medical Treatment, and FDA Approved Fraud
1956 ADVERTISEMENT
From the above advertisement, it more than plain that neuroleptic drugs called, "antipsychotics" were marketed and prescribed to control children's "unruly behavior" from the time they were first developed...
It is plain that every Federal authority with a legal duty to protect the American people from the adverse effects of prescription drugs, has failed to do so diligently. The illegal marketing continues, while the off-label prescriptions for dangerous teratogens, i.e., FDA-approved psychotropic drugs, are fraudulently billed to the Federal Medicaid program. Fraud continues unabated while mental health professionals "monitor" the prescription rates of teratogenic drugs prescribed to children that can disable and even kill them. These young patients and their parents are often not informed or the risks.; many are never told what the drugs mechanism of action is, nor are they told of the potential for experiencing serious adverse drug effects that may disable, or eve kill them. Corporate criminals are aided and abetted by regulatory failure; unethical medical professionals who use "standard practice" as an affirmative defense i.e. off label prescriptions that are unsupported by definitive evidence of safety and effectiveness; and Key opinion Leaders whose professional opinions are used to aid and abet the criminal marketing of FDA approved drugs. They're making a killing...
FDA-approved drugs kill far more people
than alcohol and illicit drugs combined...
via Public Citizen
(a nonprofit organization that does not participate in partisan political activities or endorse any candidates)
In 2008, Sidney M. Wolfe, M.D. testified before a House subcommittee that, "The situation at the FDA has never been worse than now and this can be attributed to a confluence of 3 factors:
1.Terrible leadership at the FDA, including the Commissioner and most of the Center
- Directors
- 2. Increasing reliance on industry to fund FDA activities, with almost 2/3 of the drug approval budget coming out of the $400 million+ Prescription Drug User Fee Act (PDUFA) drug allocation for FY 2008
oversight hearings by the same Congresses that have, since 1992, increasingly turned
over FDA funding to the industry" read here
via PloS Medicine:
Questionable Advertising of Psychotropic Medications and Disease Mongering
Jeffrey R. Lacasse1*, Jonathan Leo2 1 Florida State University, Tallahassee, Florida, United States of America, 2 Lincoln Memorial University, Harrogate, Tennesseee, United States of America
an excerpt:
"Wayne Goodman, Chair of the FDA Psychopharmacological Advisory Committee, admitted that the serotonergic theory of depression is a “useful metaphor”—and one that he never uses within his own psychiatric practice [6]." read here
"Wayne Goodman, Chair of the FDA Psychopharmacological Advisory Committee, admitted that the serotonergic theory of depression is a “useful metaphor”—and one that he never uses within his own psychiatric practice [6]." read here
via the FDA Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:
Shire Pharmaceuticals Warning Letter 2011 for Vyvanse an excerpt: "the subject of this letter is dated March 2008" --a warning sent three years after the fact?!
Noven Pharmaceuticals, Inc warning letter for Pexeva® (paroxetine mesylate) Tablets here
Novartis Pharmaceuticals Corporation Focalin XR® here
Pfizer Inc. CHANTIX® (varenicline) Tablets CADUET® (amlodipine besylate/atorvastatin calcium) Tablets NORVASC® (amlodipine besylate) Tablets here
Sunovion Pharmaceuticals, Inc. warning letter for Latuda, a neuroleptic, or 'antipsychotic' drug an excerpt: "The sales representative’s statements are false or misleading because they promote an unapproved use and minimize the risks associated with Latuda. Thus, this promotional activity misbrands Latuda in violation of the Federal Food, Drug, and Cosmetic Act"(emphasis mine) here these are all of the warning letters sent for psychiatric drugs in 2011 listed on the FDA website here.
Posted on a brief excerpt:
"In short, the falsely-reported results are driving prescribing practices and instilling a medical delusion about the effectiveness of these drugs." read here
The Code of Federal Regulations states that prescription drug advertisements must contain, "a true statement of the effectiveness of the drug for the selected purpose(s) for which the drug is recommended or suggested in the advertisement. The information relating to effectiveness shall include specific indications for use of the drug for purposes claimed in the advertisement"
Well it doesn't take a rocket scientist to figure out that the drug companies do not adhere to Federal Law. Even when the drug industry is caught breaking the Law, the penalty does not serve as a sufficient deterrent; pharma has not stopped using illegal methods to gain FDA approval, or market it's products. The FDA is failing as a regulatory authority; providing little, to no protection for the American people from iatrogenic harm and fatalities caused by FDA-approved drugs. It appears the drug industry is directing FDA approval and regulatory activity.
The SSRIs (as the story goes) supposedly, 'safely treats depression thought to be caused by a 'serotonin imbalance.' It is a disproved hypothesis, that became a fraudulent claim; a myth that has been used for decades to market SSRI antidepressants, and used to convince patients to take their antidepressants. No serotonin imbalance, or any other neurotransmitter has ever been identified or validated as an actual biological cause of depression, or any psychiatric diagnosis! It appears this hypothesis took on mythological proportions, and came to be accepted as a "fact, " but it is an "urban legend," without any basis in reality. This hypothetical myth, is a fraudulent claim that was repeated incessantly in drug advertisements, in professional journal articles, and in doctor's offices in "informed consent" discussions with patients and parents. It is, and always was, a drug marketing strategy---a very lucrative and successful marketing strategy that has defrauded billions of dollars mainly from publicly funded medical programs...The FDA never sent a single warning letter to any of the drug manufacturers or the medical professionals who were promoting the chemical imbalance / brain disease mythology to advertise and market drugs; and to coerce patients into treatment compliance. The FDA allowed drug manufacturers, salesmen, medical professionals and Key Opinion Leaders to perpetrate fraud in order to sell FDA approved drugs with serious risks; risks that the FDA helped unethical researchers and manufacturers bury. Not informing doctors or informing the American people in order to protect them from harm, makes it an FDA-approved fraud.
Treatment Development: The Past 50 Years
a few excerpts:
"Over the past year, several companies, including Astra Zeneca, Glaxo-Smith-Kline, Sanofi Aventis, and recently Novartis, have announced either a reduction or a re-direction of their programs in psychiatric medication R&D. Some of these companies (such as Novartis) are shifting from clinical trials to focus more on the early phases of medication development where they feel they can identify better targets for treating mental disorders. Others are shifting from psychiatry to oncology and immunology, which are viewed by some as lower risk."There are multiple explanations for these changes. For instance, many of the blockbuster psychiatric medications are now available in inexpensive generic form. In addition, there are few validated new molecular targets (like the dopamine receptor) for mental disorders. Moreover, new compounds have been more likely to fail in psychiatry compared to other areas of medicine. Studying the brain and the mind has proven to be much more difficult than the liver and the heart. Most experts feel the science of mental disorders lags behind other areas of medicine. The absence of biomarkers, the lack of valid diagnostic categories, and our limited understanding of the biology of these illnesses make targeted medication development especially difficult for mental disorders." emphasis mine read here
The last sentence emphasized above is ample evidence that Thomas Insel does not understand basic scientific principles; yet, he is the Director of the National Institute of Mental Health. The absence of an identified biological dysfunction or disease pathology, i.e. a treatment target, is characterized as a "difficulty" by Thomas Insel; it is a barrier. In medical research, development of targeted treatments follow the identification of a biological dysfunction or disease that is then "targeted" for treatment. Is it possible that Thomas Insel is unaware that conforming to scientific principles is required in ethical research? An unknown, unidentified biological dysfunction or disease is a 'hypothetical' cause for psychiatric diagnoses; it cannot ethically become a target for treatment, unless it is a validated cause of a mental disorder. Without identifying a biological dysfunction or biological disease, it's impossible to validate the disease hypothesis. To proceed without valid evidence of a disease pathology, is unethical, unscientific and belies the ethical principles of scientific research. Using a hypothesis as means of explaining a diagnosis is entirely unethical, and dishonest; yet it is standard clinical practice, and has been for decades. Pharmachological treatment for undesirable emotional and behavioral symptoms in the belief they are caused by biological dysfunction or disease, without ever identifying or validating a biological dysfunction or disease that is validated as a cause of any mental disorder, is not and cannot be a valid or ethical medical treatment. Psychiatry's "medical diagnoses" that are not supported and validated by ethically conducted research, are mythological "diseases." Psychiatry's treatment standards that are supported not by empirical evidence, but by errors of attribution, corrupt data, and subjective, i.e. biased opinions; are not medical treatments that conforms to ethical medical principles, or even "medical treatment"...
It is Human Experimentation and it is Standard Clinical Practice.
It is standard "medical treatment" that can be forced Under Color of Law.
Does that sound like good medicine that is "therapeutic?
Does that sound like good medicine that is "therapeutic?
Update February 2, 2011 at 7 pm
Six FDA scientists and doctors have filed a Federal Lawsuit alleging the FDA retaliated against them for voicing safety concerns about medical machines the FDA approved.
Six FDA scientists and doctors have filed a Federal Lawsuit alleging the FDA retaliated against them for voicing safety concerns about medical machines the FDA approved.
via The Washington Post Federal Eye Blog on February 1, 2011 Grassley Investigates FDA monitoring of whistleblowers By Lisa Rein and Ellen Nakashima
an couple excerpts:
"The plaintiffs contend the monitoring was a blatant form of retaliation. Information gathered this way eventually contributed to the harassment or dismissal of all six workers, the suit alleges.
"Grassley warned Hamburg that it is illegal for a government agency to interfere with an employee’s right to air concerns to members of Congress. He said the FDA had “no evidence” that one of the device reviewers, Paul J. Hardy, disclosed confidential business information about the devices, yet fired him after he exchanged Gmail messages with congressional staff, including an investigator who worked for Grassley."
“It is troubling to me to see your Agency actively pursue the dismissal of an employee ... not because they violated procedure and leaked genuinely confidential classified information, but simply because you “cannot trust him,” Grassley wrote. He told Hamburg the FDA’s retaliation against Hardy “directly contradicts” testimony she gave during her 2009 confirmation hearings of her intent to protect whistleblowers by “creating a culture that enables all voices to be heard.” read here
Aug 26, 2011
Since Psychiatric Diagnoses are not "Brain Diseases" or "Chemical Imbalances" what are psychiatric drugs "treating"?
Psychiatry does not adhere to the:
via PLoS Medicine a peer-reviewed open-access journal published by the Public Library of Science:
Baughman F (2006) There Is No Such Thing as a Psychiatric Disorder/Disease/Chemical Imbalance. PLoS Med 3(7): e318. doi:10.1371/journal.pmed.0030318
Published: July 25, 2006
excerpts:
"At the 1998 National Institutes of Health (NIH) Consensus Development Conference on ADHD, Carey [6] stated: “The ADHD behaviors are assumed to be largely or entirely due to abnormal brain function. The DSM-IV does not say so but textbooks and journals do.... What is now most often described as ADHD...appears to be a set of normal behavioral variations.”
"In 2002, the Advertisement Commission of Holland [12] determined that the claim that ADHD is an inborn brain dysfunction was misleading and enjoined the Brain Foundation of the Netherlands to cease such representations.
"In 2003, Ireland prohibited GlaxoSmithKline from claiming that the antidepressant Paxil “works by bringing serotonin levels back to normal.” Wayne Goodman of the FDA acknowledged that claims that selective serotonin reuptake inhibitors correct a serotonin imbalance go “too far,” but had the temerity to suggest that “this is reasonable shorthand for expressing a chemically or brain-based problem” (quoted in [13]).
"At an FDA hearing on March 23, 2006, I testified: “Saying any psychiatric diagnosis ‘is a brain-based problem and that the medications are normalizing function’ is an anti-scientific, pro-drug lie” read the entire letter
Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature
Citation: Lacasse JR, Leo J (2005) Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature. PLoS Med 2(12): e392. doi:10.1371/journal.pmed.0020392
Published: November 8, 2005
excerpts:
"Although SSRIs are considered “antidepressants,” they are FDA-approved treatments for eight separate psychiatric diagnoses, ranging from social anxiety disorder to obsessive-compulsive disorder to premenstrual dysphoric disorder. Some consumer advertisements (such as the Zoloft and Paxil Web sites) promote the serotonin hypothesis, not just for depression, but also for some of these other diagnostic categories [22,23]. Thus, for the serotonin hypothesis to be correct as currently presented, serotonin regulation would need to be the cause (and remedy) of each of these disorders [24]. This is improbable, and no one has yet proposed a cogent theory explaining how a singular putative neurochemical abnormality could result in so many wildly differing behavioral manifestations.
"In short, there exists no rigorous corroboration of the serotonin theory, and a significant body of contradictory evidence. Far from being a radical line of thought, doubts about the serotonin hypothesis are well acknowledged by many researchers, including frank statements from prominent psychiatrists, some of whom are even enthusiastic proponents of SSRI medications (see Table 1).
WHAT IS THE FDA's ROLE?
The FDA is a federal regulatory agency that approves drugs to be marketed, and has oversees the direct to consumer advertising of FDA approved drugs.
This agency approves drugs on flawed, phony and incomplete information, and does fine the companies whose drugs were approved fraudulently, nor remove the drugs from the market until they are tested for safety and efficacy. The FDA does not hold drugs manufacturers accountable for failing to provide accurate drug trial data, for failing to perform post-marketing clinical trials they are obligated to perform when drugs gain approval under the FDA's expedited approval program, the FDA does nothing when the drug companies market their products for conditions and populations that are not FDA approved. In fact for all of these crimes the FDA does virtually nothing---allowing dangerous drugs to continue being used both for FDA approved and unapproved uses.
In fact the only real value of the FDA "Warning Letters" to drug companies seem to have is that they can be used as evidence by individual states in lawsuits for false advertising. here. These lawsuits for false advertising and the ones individual states have filed for the "off-label" marketing of drugs are the only real consequences of any import the industry has faced.
The FDA has for the last several years has attempted to shield the pharmaceutical industry from lawsuits by claiming Federal Preemption; attempting to prevent people who are harmed by FDA approved drugs from being able to sue for damages in State Courts. here and here
In the year 2000 the Journal of the American medical Association reported that 106,000 deaths a year are caused by "non-error" adverse effects of prescription drugs; and acknowledges this is a conservative estimate of the actual number. This country has been waging a "War on Drugs" for decades---illicit, illegal drugs kill a small fraction of the number of people that FDA approved drugs do when used for FDA approved uses; yet there is no War to have the FDA, or the Drug industry held accountable for FDA approved drugs for the 100,000+ deaths a year caused by FDA approved drugs. Are we to assume the FDA does not think this loss of life is relevant; or that the FDA has no responsibility in regards to this unacceptable loss of life caused by the drugs the FDA has perhaps erroneously, approved?
Whose interests are being protected by the FDA? It sure isn't the interests of patients who have been disabled or killed by FDA-approved drugs. It isn't psychiatric patients at risk of being disabled or worse, by FDA approved drugs.
Jul 19, 2011
The "Anti-Stigma" Campaign Increased Discrimination
Mental Illness Stigma Entrenched in American Culture new strategies needed, study finds
ScienceDaily (2010-09-16) -- "A new study finds no change in prejudice and discrimination toward people with serious mental illness or substance abuse problems despite a greater embrace by the public of neurobiological explanations for these illnesses. The study raises vexing questions about the effectiveness of campaigns designed to improve health literacy."
I read this article and thought well, what else would the outcome be?
It is not possible to change negative attitudes derived from ignorance by misinforming the people who have them. How could being dishonest about a group of marginalized people "help" them? I was taught as a child that it is impossible to 'do good' by being dishonest. The people cannot be asked to believe "mental illness" is a "disease or disorder of the brain, like any other illness," but also be expected to believe the people who have them need to be forced to take harmful drugs. Supposedly, they need to be forced because, "they don't know what's good for them," and people are expected to believe having a "mental illness" is like having a disease like cancer or diabetes! It defies logic. Why would "mental health professionals" believe that telling people lies about the people who have been diagnosed with "mental illnesses" would be a good thing to do? Or that it would be helpful to them?! Stating that "mental illnesses" are "brain diseases" implies that the so-called, "diseases" develop in a biological vacuum. Going further and claiming one can never 'be cured,' but can only be "effectively treated," with neuroleptics, helps the pharmaceutical industry. It does not help those with a psychiatric diagnosis, to be dishonest about what people with a diagnosis experiences. A genuine effort to change entrenched ignorant societal beliefs would require accurate information, not lies. Ignorance can only be corrected by education. Any genuine effort to eliminate the stigma of a psychiatric diagnosis, needs to be based on reality, not science fiction. An honest effort requires the truth.
How is it that a deception of the masses was believed to be the best way to "bust the stigma?" In kindergarten we learned (or not) that one is supposed to follow the rules because it is the right thing to do. Now deception of the masses is supposed to inspire society at large to do the right thing for "the seriously mentally ill" because it is the right thing to do; but the reason offered to compel understanding and altruistic action is a deception? How could college educated professionals not see the glaring inconsistencies inherent in this dishonest strategy?
The anti-stigma effort in theory, was supposed to encourage the general public to stop excluding and to start including "the seriously mentally ill." Teaching the general public that "mental illnesses" are caused by "diseased brains" and that those with "seriously diseased brains" are just like everybody else. The Human Rights of those who the public is told have "brain diseases" instead of emotional, cognitive and behavioral difficulties resulting from abuse, and neglect, trauma and other types of environmental, sociological and interpersonal subjective experiences are further violated when the public believes this obfuscation.
The people and entities who benefit from this unscientific classification of emotional distress are many; and not always readily recognized. There are the obvious financial beneficiaries of academia, medicine, and pharmaceutical companies, that most can readily agree are all branches of the same twisted tree feeding off what the bible called the root of all evil, the love of money. The relative few benefit financially, earning their wage in an pale imitation of the noble characteristics required of those who practice the Medical Arts. Wages are earned by deceiving the masses; while depriving those labeled "seriously mentally ill" of their dignity and hope. Coercing patients and trusting family members alike, to gain "treatment compliance." This process did not happen overnight, and it is not a recent phenomenon.
The article in Science Daily is not the original report of the study, the original report appeared in the online version of the American Journal of Psychiatry on September 15, 2010. Here is a link to the abstract: American Journal of Psychiatry
I noticed right away in the first paragraph, the abstract did not say that mental illnesses are diseases! In fact it truthfully stated that they had been presented, "as medical diseases in efforts to overcome low service use, poor adherence rates, and stigma." So, now we have an answer to why this subterfuge was perpetrated. Primarily, it was to "to overcome low service use, poor adherence rates," i.e. to encourage treatment compliance. The lie that "mental illness," or more accurately, states of crises, are caused by biological "diseases" or "chemical imbalances" was told to get more people to take psychiatric drugs and "reduce stigma" of doing so. This is no justification for mental health professionals to lie about the very people they are supposed to be helping! In reality this plan was developed by college educated mental health professionals who seemingly perceived no moral dilemma in abandoning their ethical integrity; or in lying to patients and their families, and the American public. Incredibly, many in medicine, academia, government and industry are clinging to this lie which continues to cause the people it was intended to help further harm. On the face of it, this deception may appear to be harmless, as it is instigated to supposedly achieve better "medical treatment" for those unfortunates with "diseased brains."
Looking closer, it appears to be an attempt to misinform the general public and thereby gain support for bio-psychiatry practitioner's methods of "practicing medicine." These methods include coercing the "seriously mentally ill" and "teaching" by manipulating their family members and the general public into supporting social control strategies, that are being called, "medical treatment." Human Rights violations that happen as a matter of course for those with the label of "serious mental illness" we are told by bio-psychiatry's devotees are justified; because, "seriously mentally ill" people lack insight! Llaws have been passed mandating this "medical treatment," which does not help the vast majority "treated" with neuroleptic drugs; but in fact hurts them. A particularly cruel twist to the "anti-stigma" lie, when one considers the fact that neuroleptic drugs induce iatrogenic neurological and metabolic abnormalities, leading to disability and early death; sometimes sudden death, regardless of the age of the patient.
Reading just the abstract for the American Journal of Psychiatry article, and the article written about this study for Science Direct, I could not help but notice that it seemed that the message was somehow different in Science Direct. In the final paragraph of the AJP abstract, which acknowledges the two effects of the strategy to increase awareness of the need for those labeled to be treated with medication The campaign to promote the belief that "mental illnesses" are diseases like any other diseases; resulted in an increase in support for "treatment;" but ironically, it also led to an increase in rejection experienced in the community by those with a psychiatric diagnosis!
This means that once the general public believes the deception offered by the "anti stigma" campaign, the people who have a psychiatric diagnosis experience more rejection. Rejection of a person due to a psychiatric diagnosis is inhumane and leads to isolation and loneliness. This study supports the belief of many survivors: Stigma originates with and is attached to the psychiatric diagnosis itself. The strategy to garner community acceptance and inclusion for "the seriously mentally ill" actually led those diagnosed with a psychiatric "mental illness" becoming more isolated, and experiencing more rejection. Perhaps it is time for the professionals who develop these grand ideas to help others, to tell the truth. Perhaps these professionals need to ask those they wish to help, "What can we do to help you?"
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