Drug safety affects all of us

via Today in Science History:
"It is not enough that you should understand about applied science in order that your work may increase man's blessings. Concern for man himself and his fate must always form the chief interest of all technical endeavours... in order that the creations of our minds shall be a blessing and not a curse to mankind. Never forget this in the midst of your diagrams and equations." Albert Einstein Address to students of the California Institute of Technology, Pasadena, California (16 Feb 1931). In New York Times (17 Feb 1931), p. 6

via ALLIANCE FOR HUMAN RESEARCH PROTECTION:

 

The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected www.ahrp.org

Advancing Honest and Ethical Medical Research 

Vital drug safety information should never be hidden as a “trade secret.”  Drug manufacturers who obtain a public license to market their drugs should have to provide access to vital safety information.

After much debate, an important public safety program begun in 2010 by the European Medicines Agency (EMA) provided access to physicians and the public to the data from clinical trials that drug manufacturers used to gain marketing approval for their new prescription medicines in Europe.

The program was hailed by American, and European researchers--indeed by researchers around the world--as a major step towards improving drug safety.

Prior to the EMA disclosure program, the only way access to clinical trial data was gained was through lawsuits.

But by the time any legal action had been taken against a drug manufacturer for failure to disclose serious adverse effects, the companies had amassed their mega-profits, but thousands of patients suffered serious harm. That scenario cannot be tolerated.

AbbVie is the manufacturer of Humira, the number one selling medication in the world with projected sales of $10 billion in 2013; and InterMune, manufactures the pulmonary-fibrosis drug Esbriet that has recently been approved in Europe at a cost of over $40,000 per year.

These two companies have filed a lawsuit against the EMA in an effort to block access to vital safety information about the serious risks the companies know that these drugs pose.

Their motive is simple and self-serving: they are attempting to protect their profits by concealing their products' hazards. 

They are demonstrating that they have no regard for the safety of those who consume their drugs--their only concern is for their profits.

Please sign the petition--drug safety affects all of us.

Link to petition: http://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-welch-of-intermune-drop-your-legal-action-blocking-access-to-ema-clinical-trial-data

The petition calls upon AbbVie and InterMune to drop their European Union lawsuit and release all patient level data on Humira, Esbriet and their other products.

 Copies of the petition have been sent to:

President Barack Obama;

Margaret Hamburg, M.D., Commissioner, Food & Drug Administration;

Secretary General Ban Ki Moon, United Nations;

World Health Organization Director Dr Margaret Chan.

Sign the petition and pass on the request to your colleagues, as I have.

With very little effort, you may help move mountains!

Vera Sharav

cartoon Roger Schillerstrom Drug Discovery and Development 2008

I say it's quackery...

Medical standards of care originally were based on clinical research and clinical experience; ethical medical standards originally were diagnostic procedures and treatments for symptoms and medical illnesses with known risks and potential benefits discussed for informed consent for prescribed treatment. Standards of care protected patients from unsafe medical practices and unethical professionals. The standards being promulgated for use in standard psychiatric clinical practice and recommended for use in pediatric and general medical clinics currently are written to conform to what is, and has been standard practice in real world mental health clinical practice for decades.

In real world clinical practice, it not unusual for irresponsible off label prescribing of dangerous psychotropic drugs with little, if any empirical support; i.e. drugs are prescribed for no valid, ethical medical purpose. Incredibly, drugs are prescribed without empirical evidence of either the drug's safety or effectiveness for the patient, and/or the condition and/or syptom the drug is prescribed to treat, drugs are sometimes the only "treatment" available. Psychiatry's current standards of care protect psychiatrists and the other medical practitioners who are trained to practice "psychopharmacology," not evidence based medicine, social and political control of individuals based on consensus of professional opinions.  Psychiatric "standard treatment" endangers patients. Obviously, psychotropic drugs which have teratogenic effects and have inherent risks which include cognitive, neurological and physical disabilities and early/sudden death. Once drug impaired, psychiatric patients are limited in their capacity to complain of mistreatment and effectively advocate for themselves. Many will develop drug-induced cognitive, neurological, metabolic, and cardio-vascular impairments which are medically neglected by the doctors who inflict them.

Apparently, it's an article of faith for psychopharmacologically inclined psychiatrists to believe the subjective observations and opinions of psychiatrists can miraculously transubsantially transform agreed upon opinions and beliefs into "scientific evidence" through a quasi-democratic process of consensus. Imagine that! A consensus of the opinions of psychiatrists validates psychiatric diagnostic criteria. Psychiatrists agree teratogenic drugs are therapeutic and "necessary" by legal force if required. Seemingly, by ignoring the direct adverse effects of teratogens on their patients,  psychiatrists become willfully blinded to disabilities and infirmaties, the iatrogenic medical injuries that consensus based psychiatry inflicts upon humanity with seeming impunity.

In every other field of scientific inquiry, subjective observation and opinion is suitable only to support findings and conclusions derived from empirical data collected in research and real world practice. Educated subjective opinions and observations are no substitute for medical knowledge gained from ethical scientific research, and thoughtful consideration of all available data. Using medical terms,  relying on consensus without offering valid empirical evidence to support psychiatric standards of care is an egregious abuse of power, authority and medical  privilege---There is no substitute for empirical evidence, and no excuse for abdicating the use of sound medical judgement and ethical medical principles.

Psychiatry's consensus-based diagnostic manual, the DSM, and consensus-based treatment algorithms such as TMAP and , are not ethically, medically or scientifically valid. TMAP and T-MAY, are consensus-based treatment protocols developed to market drugs and/or unethically "validate" off label prescription of dangerous FDA approved drugs; i.e. off label prescribing becomes psychiatry's "standard of care"absent empirical support or contrary to available evidence of either  drug safety or effectiveness for patient or symptom or condition...

How did off label use of dangerous drugs become so common, more importantly, how can it be considered ethical or even a "standard medical practice?" Psychotropic drugs are teratogens; yet they are prescribed without evidence of effectiveness, even though they have inherent, disabling, even fatal risks.

Abuse of prescription privileges. 

Psychiatry: a consensus-based standard of care. 

Psychiatry's so-called standards of care are commonly used to "validate" the prolific off label prescribing of neuroleptic, or so-called "antipsychotic" and other psychotropic drugs to children, the elderly and traumatized veterans. Treatment algorithms are based on consensus and "validated" by a quasi-democratic process. In reality, what are obviously political decisions are the justification, not exactly the needed evidence base, for so called standards of care. These "standards" which primarily serve to protect practritioners who use them by providing a pre-emptive affirmative defense against medical malpractice for iatrogenic injuries. Standards of care shield psychiatrists against malpractice claims for drug-induced iatrogenic injuries, permanent disabilities weven  fatalities inflicted with impunity. Most victims are mostly poor and/or reliant on Federal Medical programs. Marginalized by poverty, stigmatized with a diagnostic label, patients can be systematically dis-empowered a direct effect of legislating bigotry. Grass roots advocates who proclaim themselves to be "The Nation's Voice on Mental Illness" do not acknowledge psychiatric survivors/victims, much less advocate justice for victims of iatrogenic harm, educate the public about drug-induced disease, disability and death. The Nation's Voice does not speak for those who are killed as a direct result of psychiatric treatment.

via 1 Boring Old Man:

a mess, [still] deserving close attention…

a couple of excerpts:

"Childhood Psychosis is an uncommon finding, but can be associated with significant impairment, and the article mentioned by Dr. Purssey purports to be discussing childhood psychosis. But we all know that the extensive use of Atypical Antipsychotics in children [Medicaid children] isn’t about childhood psychosis at all. It’s off-label uses. The drugs are being prescribed for behavior control. That’s where the costs come from. That’s where the dangers are. That’s where the risk/benefit equation has been massively perverted. That’s the reason for the alarm. These are the kids that were inappropriately labeled Bipolar, justifying the use of these medications.

"There can be little question that the incidence of behavioral problems among the children on Medicaid is quite high. In fact, it would be surprising if that weren’t the case. Many of them are foster children or otherwise born into families in difficult circumstances. And for all its glitches, our foster-care system beats the orphanages of a former time hands down. These medications can be somewhat effective in situations when these children inevitably present with behavior problems, but at a very high price. Foremost, this is not a situation best approached by symptom control. Childhood is not something to be gotten through. It’s the period of complex development that shapes directions for a lifetime. This is a self-evident truth. It’s impossible to imagine that the important work of childhood can proceed through the fog of Antipsychotics – so the side effects such as the metabolic syndromes are an additional burden to children already swimming up-stream. Rampant medication in these situations is a clearly inappropriate and dangerous medical solution to a psycho-social problem. This is not simply something to decry. It needs to be stopped." read here

Here is the latest treatment algorithm to ensure kids will be drugged: 

via The Reach Instittute

T-MAY: Treatment of Maladaptive Aggression in Youth

Psychotropic agents are increasingly prescribed to aggressive youth on an outpatient basis,^5–7 despite limited efficacy and safety data.⁶ For example, sixfold increases in outpatient antipsychotic prescriptions were found between 1993 and 2002,⁸ followed by further increases between 2002 and 2006,⁹ largely with aggressive, nonpsychotic youth. These practices fall largely outside of indications approved by the Food and Drug Administration, raising concerns about efficacy, safety, role of alternative therapies, polypharmacy, and appropriate parent engagement and education.⁹Furthermore, a significant portion of antipsychotic prescribing takes place by primary care physicians, including pediatricians. For example, an estimated 32.2% of antipsychotic prescriptions for children ages 2 to 18 during 1995–2002 were by non–mental health providers.¹⁰ Evidence-based guidance is necessary for implementing care that addresses patients’ severity and source of symptoms, development, primary diagnosis, coexisting conditions, and family situations.¹¹

To address these needs, the Rutgers Center for Education and Research on Mental Health Therapeutics, in collaboration with Columbia University, the REACH Institute, and others, launched a consensus development initiative to address the outpatient management of maladaptive, impulsive aggression in children and adolescents.

Treatment of Maladaptive Aggression in Youth: CERT Guidelines I. Engagement, Assessment, and Management

Treatment of Maladaptive Aggression in Youth: CERT Guidelines II. Treatments and Ongoing Management

updated 2-17-2014

SUPPORT: oxygen supplementation experiment in premature babies

via The Alliance for Human Research Protection:

OHRP Caves Under SUPPORT Pressure Re: oxygen experiment tiny premature babies
Wednesday, 05 June 2013
Proposal by powerful medical research stakeholders who "argue for completely eliminating the need for any consent in similar studies."

BEWARE of the powerful influence of institutional medical research.

They have pushed hard to get the federal research oversight agency, OHRP, to backtrack from its oversight action after determining that there was an institutional failure of compliance with Federal regulatory requirements by medical centers that conducted the SUPPORT oxygen supplementation experiment in premature babies. http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf

In a letter to the the University of Alabama (May 4, 2013), OHRP alerts the public that powerful forces are intent on lowering the bar for medical research ethics. The June 4 letter in part states:

"Ultimately the issues come down to fundamental difference between the obligations of clinicians and those of researchers. Doctors are required, even in the face of uncertainty, to do what they view as being best for their individual patients. Researchers do not have the same obligation: Our society relaxes that requirement because of the need to conduct research, the result of which are important to us all. As a trade-off in allowing researchers such flexibility, society requires that researchers tell subjects how participating in the study might alter the risks to which they are exposed."

OHRP does reamain (sic) steadfast in its finding that the SUPPORT consent forms failed to disclose the increased risks to parents--including risk of death:
"it would seem appropriate that the parents of the infants should have been informed of the real concerns withing (sic) the medical community regarding those [high and low end of ] oxygen levels" to which babies may be randomly assigned in the study.

Lest anyone have any doubt about the ultimate goal of the powerful government-sponsored researchers who conduct high risk experiments, OHRP notes that:

"some of the researchers involved in the SUPPORT study and others have argued that there was no need for researchers to have obtained any consent from parents before placing their children in this study.

This discussion takes place in the midst of a much broader discussion regarding a proposal from a distinguished group of scholars that is receiving prominent attention, which argues for completely eliminating the need for any consent in similar studies." (emphasis mine)

"These are crucially important issues, not just with regard to our ability to be able to conduct research with appropriate oversight, but also with regard to fundamental questions about the obligations owed by doctors to patients."

"Most important, given the controversy engendered by our determination in the SUPPORT study, we will ensure that the process for producing guidance [on what the rules are with regard to disclosure of risks in randomized studies whose treatments fall within the range of standard of care] is as open as possible, to allow input from all interested parties."

OHRP promises to conduct an open public meeting on this topic.

In the meantime, OHRP has "put on hold all compliance actions against UAB to the SUPPORT case, and plan to take no further action in studies involving similar designs until the process of producing appropriate guidance is completed."

Take action to prevent a return to pre-Nuremberg medical research standards when medical atrocities were committed "for the greater good."

We, the 99.9% are at increasingly high risk of becoming human guinea pigs without our consent.Vera Sharav here

via the American Medical Association 

Opinion 8.08 - Informed Consent

The patient’s right of self-decision can be effectively exercised only if the patient possesses enough information to enable an informed choice. The patient should make his or her own determination about treatment. The physician's obligation is to present the medical facts accurately to the patient or to the individual responsible for the patient’s care and to make recommendations for management in accordance with good medical practice. The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice. Informed consent is a basic policy in both ethics and law that physicians must honor, unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent. In special circumstances, it may be appropriate to postpone disclosure of information, (see Opinion E-8.122, "Withholding Information from Patients").

Physicians should sensitively and respectfully disclose all relevant medical information to patients. The quantity and specificity of this information should be tailored to meet the preferences and needs of individual patients. Physicians need not communicate all information at one time, but should assess the amount of information that patients are capable of receiving at a given time and present the remainder when appropriate. (I, II, V, VIII)

Issued March 1981. Updated November 2006, based on the report "Withholding Information from Patients (Therapeutic Privilege)," 

Opinion 8.082 - Withholding Information from Patients

Withholding pertinent medical information from patients under the belief that disclosure is medically contraindicated, a practice known as “therapeutic privilege,” creates a conflict between the physician’s obligations to promote patients’ welfare and respect for their autonomy by communicating truthfully.   Therapeutic privilege does not encompass  withholding  medical information in emergency situations, or reporting medical errors (see E-8.08, “Informed Consent,” and E-8.121, “Ethical Responsibility to Study and Prevent Error and Harm”). 

Withholding medical information from patients without their knowledge or consent is ethically 

unacceptable.  Physicians should encourage patients to specify their preferences regarding 

communication of their medical information, preferably before the information becomes available.  Moreover, physicians should honor patient requests not to be informed of certain medical information or to convey the information to a designated proxy, provided these requests appear to genuinely represent the patient’s own wishes. 

All information need not be communicated to the patient immediately or all at once; physicians 

should assess the amount of information a patient is capable of receiving at a given time, delaying the remainder to a later, more suitable time, and should tailor disclosure to meet  patients' needs and expectations in light of their preferences. 

Physicians may consider delaying disclosure only if early communication is clearly contraindicated.  Physicians should continue to monitor the patient carefully and offer complete  disclosure when the patient is able to decide whether or not to receive this information. This  should be done according to a definite plan, so that disclosure is not permanently delayed.   

Consultation with patients’ families, colleagues or an ethics committee may help in assessing 

the balance of benefits and harms associated with delayed disclosure.  In all circumstances, 

 physicians should communicate with patients sensitively and respectfully.

More on the SUPPORT study Public Citizen: The SUPPORT Study was Even Worse than We Thought by Michael Carome and Sidney Wolfe via The Hastings Center Bioethics Forum blog

Public Citizen Report to the Secretary of HHS: New Information About Baby Trial Shows It Was Even More Unethical Than Originally Thought via Public Citzen

photo credit: Wikimedia Commons

'let’s hope that we don’t have a new challenge on our hands'

Lincoln was prophetic in his fears for the safety of the Republic.

"I see in the near future a crisis approaching that unnerves me and causes me to tremble for the safety of my country. As a result of the war, corporations have been enthroned and an era of corruption in high places
will follow, and the money power of the country will endeavor to prolong its reign by working upon the prejudices of the people until all wealth is aggregated in a few hands and the Republic is destroyed."
The passage appears in a letter from Lincoln to (Col.) William F. Elkins, Nov. 21, 1864. source

via Neuroself written by Peter Freed, M.D.:

Eisenhower’s Ghost and Obama’s Brain

an brief excerpt:

"Now look, I’m as excited about the brain as anyone. Maybe moreso. Look – here’s the government record my own $800,000 NIMH grant to prove my bonafides. I’m looking forward to reading and writing and thinking about the research that comes out of BRAIN over the coming decades, and watching many of my friends get funding through this program.  But I also know that the Royal Society – and Eisenhower – were onto something...  

read here

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

  3. Relative to the 1970’s and 1980’s, a perilously low level of Congressional oversight and 

   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

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.

via Mad in America Should the Medical Literature Be Cleansed of All STAR*D Articles?

Posted on May 5, 2011 by Robert Whitaker   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.

via NIMH Directors Blog December 14, 2011

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? 

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. 

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

Fox in the hen house source
Vintage Drug ad source 
Regulatory and Ethical Failure in Mental Health Treatment and Drug Advertising 2-2-12

What was once an illusion is now delusion

via ScienceDaily:

Science News

Unruly Kids May Have a Mental Disorder

a couple excerpts:

"ScienceDaily (Apr. 29, 2012)  When children behave badly, it's easy to blame their parents. Sometimes, however, such behavior may be due to a mental disorder. Mental illnesses are the No. 1 cause of medical disability in youths ages 15 and older in the United States and Canada, according to the World Health Organization.

"It's also important to understand that mental illnesses are a developmental brain disorder even though they can look like behavior problems," Dr. Insel explained." read here

Insel's statement is not grounded in scientific findings, ethical medical principles or common sense. 

Thomas Insel, has been the front man for an effort to maintain the charade that psychiatry is an ethical medical specialty that treats actual diseases. Apparently, the "Stay the Course" agenda of treating emotional and behavioral difficulties children and adults experience as if the difficulties are symptoms of an unidentified "brain disease" requires no actual evidence. Without definitive evidence supporting the disease hypothesis, it isn't even a theory, let alone a scientific finding or medical certainty. Insel's statement is merely an unsubstantiated belief; a belief that belies understanding of the existent "evidence-base" and ethical medical principles. Insel is entitled to his opinions, but it is irresponsible and ethically unacceptable for him to share his opinions when being interviewed in his official capacity as the Director of National Institutes of Mental Health. The fact that his belief is shared by others who are convinced that the discovery of evidence that will vindicate their belief is right around the translational science corner, Insel's statement compounds the potential for confusion about what is and is not known about etiology of psychiatric diagnoses. Insel's lack of judgement in voicing his personal opinion, in effect, seems to confer a patina of scientific validity to a belief.

Firmly held beliefs and shared opinions are no substitute for empirical evidence; shared beliefs and opinions  do not imbue the standards used in psychiatric clinical practice with validity, safety and effectiveness. Absent the scientific evidence that is (theoretically) required in order for a diagnostic criteria and treatment protocol to be considered a valid, ethical, medical standard; mental illnesses have been declared by psychiatric decree to be caused by disease and/or defect, and treatment standards are developed using the same quasi-democratic process of consensus; becoming standards simply because they have been decreed to be standards by psychiatrists.  Psychiatry "validated" diagnostic and treatment standards with a quasi-democratic process, i.e. a vote taken by psychiatrists. If one carefully reads these standards and protocols it is apparent that empirical evidence is often not cited in support of the conclusions; empirical support is required to comply with and conform to ethical scientific and medical principles. The primary basis of psychiatric diagnoses and treatment protocols designated as standards of care for use in clinical practice is consensus; i.e. evidence of agreement. Agreement is no substitute for empirical evidence; consensus does not support or verify diagnostic and treatment validity, reliability, safety or effectiveness. Consensus cannot quantify risks to patients.  

Psychiatrists have been perpetrating fraud. Shared beliefs and opinions have been substituted for empirical evidence. Conviction that one's beliefs are valid is not empirical evidence of the validity of a hypothesis, nor is it a justification for psychiatry abusing it's medical authority or violating the trust of patients and families in the misguided notion the foundation of psychiatry's standards of care could be supported and validated by beliefs and opinions. More importantly, how does a conviction that one's beliefs and opinions are valid cause an individual, let alone virtually an entire medical specialty to justify using deceit, fraud and coercion to manipulate patients, to misinform and manipulate parents and others to be complicit in manipulating, controlling and coercing patients into being "treatment compliant?" Psychiatry has been using fraud, a crime, to implement and enforce an unethical standard of care in order to "medically treat" unidentified metaphorical diseases. This is not an ethical, medical practice obviously; nor is it done with an altuistic intent to serve a patient's best interest. Fraud is never used to benefit those who are being deceived; this fraud has been used to implement and enforce what psychiatry claims is "necessary medical treatment" for children and vulnerable adults diagnosed with mental illness for decades. Some are compelled under Court Order if they are unwilling to submit to psychiatric authority, which belies the claim that necessary medical treatment is what psychiatry provides, When did deceit, fraud, and coercion; outright criminal behavior, become acceptable methods to use in the practice of medicine?

The fraudulent claim is used in standard clinical practice to coerce patients and parents of children who are patients into believing there is a disease which requires psychotropic drugs to treat it. It is a fraudulent claim meant to convince patients and parents of children, of the necessity for "treatment compliance." It is used in order to perpetrate fraud.  A claim that is not based on facts used in the hope that if believed, it will modify a person's behavior and gain their cooperation, is by definition, a fraudulent claim, This particular claim is used specifically to convince adult patients, children, youths and their parents to comply with psychiatric treatment. People who believe the claim and comply with psychiatric treatment have, more often than not, sustained iatrogenic injuries; some have been disabled or killed by the direct adverse effects of the drug/s they were prescribed. How many patients and their families have been misled, and were never warned about the well-known adverse effects, iatrogenic injuries and diseases that are well-documented intrinsic risks of the drugs they are prescribed? 

I know from pain-filled experience that when these risks become actual injuries, psychiatrists will often claim the drugs do not cause the brain damage and other iatrogenic injuries; many will declare that even obvious iatrogenic injuries are simply symptoms of the psychiatric diagnosis itself.  I can assure you, as the mother of a victim of psychiatric abuse and torture, my agony is, at times unbearable, I know my son was intentionally victimized by dishonest, unethical psychiatrists who lied repeatedly, psychiatrists who abused their authority and power and used the disease hypothesis as an excuse to justify medical malpractice. Treatment not supported by evidence of safety and effectiveness is human experimentation; and it is an accepted practice in the standard of care used in clinical psychiatric practice. Every psychiatrist who treated my son, particularly the lead researcher for childhood schizophrenia, Jon McClellan, intentionally perpetrated fraud in their (mis)treatment of my son. A belief that my son's symptoms were evidence of an underlying disease, is not actual evidence---this now familiar metaphor is simply an intrisic part of the fraud being perpetrated by psychiatrists,  My son is neurologically and cognitively impaired; he has been victimized repeatedly in effect, he was tortured by psychiatrists who acted with impunity. Every single one of the so called doctors who (mis)treated my son knew he was a victim of horrific abuse; and every single one of them knew he had severe PTSD and Left Temporal Lobe Epilepsy as a result.

This new program that Thomas Insel is marketing, is the same old progrom.  It is certainly no way to regain lost credibility; absent ethical integrity, the psychiatric profession will continue to lose credibility for failing to be accountable for the harm psychiatric diagnosis and treatment causes. Stating this particular claim with authority when psychiatry still does not have valid and reliable diagnostic criteria, is unethical; and it is entirely irresponsible without definitive evidence an actual disease even exists.  In effect, Insel is claiming that without duplicable, reliable i.e. valid, data; that psychiatric diagnoses are in fact the result of an unidentified, and incurable pathology that has not yet been found.  This is nothing more than an attempt to use his authority and pseudo-scientific sounding terminology to continue to market the same old illusion that psychiatry is treating actual medical diseases. In truth, the drugs psychiatry uses cause diseases that psychiatrists then medically neglect; increasing the risks for iatrogenic disabilities, and decades early sudden death, which is in truth, homicide.  Insel apparently believes that psychiatrists can practice ethical patient-centered medicine without valid diagnostic criteria, and without relying on empirical evidence as the evidence-based foundation for practice parameters, treatment protocols, and standards of practice. 

Psychiatry isn't "evidence-based medicine." Without evidence, i.e. valid research data that supports and validates reliable diagnostic criteria, the treatments provided, and the standards of care used; it is evident that psychiatry does not value using sound ethical medical judgement or obtaining informed consent from patients. To some psychiatrists, these are not ethical duties performed, but affectations that are barely paid lip-service.

Primum non nocere.

What was once an illusion is now delusion.

portions of this post first published as "The illusion of psychiatry and 'Translational Science'" 4-29-2012

Medicating Normalness: Saying "Know" To Drugs

photo from Alan Cassales' presentation

via Ictv Victoria:
Are we over-medicating ourselves and our children? Drug policy researcher Alan Cassels discusses the drug industry; the methods and practices on how they operate and he questions whether or not we need to take as many prescription drugs as we are lead to believe for that 'quick fix' in our lives.

©2010 Lazarus Productions

via 

Researcher Alan Cassels scrutinizes medical screening tests in new book Seeking Sickness

by CHARLIE SMITH on MAY 23, 2012 at 3:51 PM

FOR A LOT of people, their health is defined, in part, by a number. What is their cholesterol level? What is their body-mass index? For those with concerns about osteoporosis, there’s a “T-score”, which measures bone density. Most recently, there was a flurry of news reports about PSA tests, which calculate levels of a prostate-specific antigen.

University of Victoria pharmaceutical-policy researcher Alan Cassels calls these numbers “surrogate markers”. They supposedly offer a clue into the risk of developing an underlying condition—such as a heart attack, stroke, bone disease, or prostate cancer—but he insists that this isn’t always the case.

“Frankly, a lot of the drugs and a lot of the tests are marketed on their ability to check what this surrogate marker is…without really altering the underlying condition,” Cassels says by phone from his home in Victoria.

In his new book, Seeking Sickness: Medical Screening and the Misguided Hunt for Disease (Douglas & McIntyre), In his new book, Seeking Sickness: Medical Screening and the Misguided Hunt for Disease (Douglas & McIntyre), Cassels offers a consumer’s guide to an array of tests covering various diseases, including many forms of cancer. There are separate chapters on breast and lung testing, indicating risks that the general public may not be aware of. Colon- and cervical-cancer screening also receives a great deal of attention, as do the potential consequences of having a biopsy. And there are some frightening stories about the downside of having your cholesterol checked.

On the upside, Cassels says the Pap smear is the test that saves the most lives and is backed by the best science. “Cervical cancer is something you can detect early,” he states. “You can do something to change the course of the disease. And what you do is not going to have other serious side effects.”

In his book, he also explores eye exams, mental-health screening, and genetic testing. Readers discover that sometimes, these tests convince physicians to take action that can cause more harm than good.

A classic example is the PSA test, which helps doctors diagnose prostate cancer. Earlier this week, the United States Preventive Services Task Force published a paper in the peer-reviewed Annals of Internal Medicine recommending against this screening method for asymptomatic men of any age.

“Strong evidence shows that PSA screening is associated with significant harms,” the USPSTF stated. “Nearly 90 percent of men with PSA-detected prostate cancer undergo early treatment with surgery, radiation, or androgen deprivation therapy. Evidence shows that up to five in 1,000 men will die within one month of prostate cancer surgery and between 10 and 70 men will survive, but suffer life-long adverse effects such as urinary incontinence, erectile dysfunction, and bowel dysfunction.”

It’s a recommendation that Cassels agrees with. “The fact that one of the biggest organizations in the U.S. that advises on screening is giving a major thumbs down to one of the most popular forms of cancer screening—this is a pretty big deal,” he says. “It’s been in the works for a long time. I totally agree with it because they’re finally recognizing that when you quantify the benefits and the harms, you’re helping very few men by screening them for prostate cancer.”

He adds that there’s a difference in the way prostate cancer is often treated in the United States, compared with in this country. “In the U.S., it’s really seen to be a serious moneymaker,” Cassels says. “You’ve got hospitals and cancer centres buying these big robots—these high-tech $5-million robots—and then they market this as the cleanest, best way to get your prostate removed.”

He bluntly writes in his book that “urologists have an unavoidable conflict of interest regarding PSA screening because…so much of their work depends on treating prostate cancer when they see it.” Therefore, he suggests, it is hard for them to be critical of these tests. However, Cassels points out that studies have demonstrated that men whose prostate cancers are revealed through these diagnostic examinations do not live longer than those whose cancers were discovered in other ways.

One of the more entertaining sections of the book concerns self-screening for diseases over the Internet. He reports in the book that pharmaceutical companies sometimes put simple tests online with the goal of encouraging people to see their doctor to receive more tests. The ultimate objective is to sell more prescription drugs.

“You can imagine [Straight sex columnist] Dan Savage giving you a test with five questions to see if you’re sexually repressed,” Cassels says with a laugh. “It’s easy to answer ‘yes’ to several of the questions. In the case of a lot of these tests, the punch line is see your doctor, who would order a screen or prescribe a drug, right?” here

Alan Cassels website
Alan Cassels on twitter