Psychiatric Drug Facts via breggin.com :

“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
Showing posts with label Adverse Effects. Show all posts
Showing posts with label Adverse Effects. Show all posts

Feb 4, 2013

Abilifried: 3 takes on Abilify®








via Drug Discovery News' Virtual Break Room

by Amy Swinderman, ddn Chief Editor

Pharma news of the weird: Cartoons, government and beer

Have you ever seen a new drug commercial and literally said, out loud, “WTF?” Pharmaceutical company commercials often raise the ire of critics, but one in particular really has me scratching my head, and tops my little collection of weird news developments in the pharma arena.

A recent commercial for Bristol-Meyers Squibb Co.’s (BMS) antidepressant Abilify depicts a patient-doctor interaction, done in cartoon form, in which a patient sheds her “blue robe” of depression and heads in to ask her doctor if Abilify is right for her.

You can see the commercial on YouTube here.

BMS’ choice to use cartoons instead of real people is puzzling—but wait, the commercial is about to get weirder. Inexplicably, instead of telling his patient about the drug and its possible side effects and drug interactions, the doctor pulls down a projection screen … and allows a different cartoon version of himself to do the talking. Meanwhile, the animated blue robe looks on, blinking.

Are you following that? Me neither. Aren’t these commercials controversial enough without rocking the boat this much?

Meanwhile, in government news (which is frequently weird) … while the U.S. Food and Drug Administration (FDA) is often criticized for the speed by which it approves new drugs—and lawmakers continue to put forth legislation that aims to ease bottlenecks in the process—a recent report claims that new drugs are actually approved faster here in the United States than in Europe or Canada.

According to Yale University School of Medicine researchers, their recent study of drug-approval decisions made in the first decade of the new millennium refutes the common belief that the FDA’s drug-approval process is especially slow.

After studying decisions made by the FDA, Health Canada (the Canadian drug regulatory authority) and the European Medicines Agency (EMA), the researchers found that the FDA’s reviews were more than three months faster than those of its Canadian and European counterparts.  here

The study mentioned above, "Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies" Nicholas S. Downing, A.B., Jenerius A. Aminawung, M.D., M.P.H., Nilay D. Shah, Ph.D., Joel B. Braunstein, M.D., M.B.A., Harlan M. Krumholz, M.D., and Joseph S. Ross, M.D., M.H.S.
N Engl J Med 2012; 366:2284-2293

Dec 30, 2012

Do we actually have "Parental Rights" if they are not preserved or defended?


It has been said that parental rights and family values are traditional "American values."  What are 'Parental Rights'?  Are parental rights protected because these rights are defined and codified within civil and administrative law?  When parental rights are diminished, altered, or revoked and a parent's Substantive and/or Procedural Due Process rights were not effectively preserved or observed, there is often no recourse available. This can happen without some parents even realizing that is what has occurred. It is not  uncommon for a  parent's rights to be violated as a matter of course when individuals and families come into contact with Child Protective Services, and or mental health and substance abuse treatment providers.

The average person working within these human service professions receive little to no training on how to preserve or protect the rights of people they will be serving; and just as importantly, how to avoid violating the person's rights out of ignorance...In my experience, social service and mental health professionals do not have even a basic understanding of what a client's individual rights are; nor do they have a minimal awareness of the fact that not observing the effective mechanisms codified within the law meant to preserve and defend those individual rights, means these rights are not effectively preserved; but are in fact violated with impunity. The impact this can have on any child should be of a concern to all of us, as these are people working for us.

The mandate of Child Protective Services is to preserve and foster a family's unity, with the understanding  that a family is the primary social unit within our society and that absent abuse or neglect, a parent has the right to raise a child according to the parent's self-determined morals and values. CPS is mandated to support this by providing social services which assist families who are in crisis, and also by providing foster care when children who are in immediate danger and must be removed due to parental abuse or neglect.  One of the most troubling aspects of this program is the statistic that children removed by 'child protective services,' are abused and killed at a higher rate than those who are not removed from their families. In recent years, parents who are do not consent to giving a child teratogenic drugs has resulted in CPS action, and the removal of children to enforce a prescription of psychotropic drugs; clearly an abuse of power and authority.

This is an ongoing and growing problem caused by the failure to inform/educate individuals who are state employees or state contractors how to perform the legal duties required of them and an abject failure to hold mandated reporters responsible when they fail to file reports with Law Enforcement they are required by law to file. The failure is specific to known or suspected instances of abuse or neglect which victimizes children or vulnerable adults who receive services through DSHS programs. State employees compound the crime by failing to refile the reports they are mandated by law to file. Failure to report is a gross misdemeanor crime. The individuals who commit this crime keep their jobs; the victims are left to tend their injuries with a brutal realization that they are not protected from harm. Supposedly, this is done in service to the state, to protect it from potential liability.

In this instance, "the state" is everybody except the victim(s). This strategy is hardly serving us as a society, it isn't consistent with how potential liability should be defined in such a scenario. Most obviously, allowing people who have failed to act in defense of a child and who fail to report abuse or neglect crimes, should not be in a position of any responsibility; such a person is in fact, a liability. Unless of course, society acknowledges that this approach is used because it serves to protect state employees who increase the state's potential liability for the damages caused by these same employees' ethical and criminal failures. The effect is to protect primarily agents of the state who are putting us at risk of further liability because they lack the fortitude to perform their jobs they are paid to perform. Specifically, taking care of children and vulnerable adults, directly or by performing jobs in support of that mission.

How many times have we heard that Child Protective Services or Adult Protective Services employees have failed to make legally mandated referrals to Law Enforcement for criminal investigation? Has there ever been any criminal investigations and prosecutions for this abject failure?  It seems that the only way anyone is held accountable is by the victim filing a lawsuit. Other than being legally compelled from outside of DSHS, I have never heard of a person experiencing any consequences such as losing their job or being prosecuted for Failure to Report, have you?  The lack of accountability for state employee's or assignee's  failure to perform  the legal duties required of the job; is a liability to the state. It is the individual's ethical and legal failure, which becomes the state's justification to cover up such failures which puts more children and vulnerable adults at risk, so that DSHS can avoid being found negligent and liable for damages.  This strategy ensures that children and vulnerable adults will be victimized and harmed, disabled and killed. Once they are victims, the victims are perceived as be a liability to be avoided. They are not treated as victims to whom the state owes a duty to protect from further harm, nor are they treated as crime victims and provided help to recover.

Children's Administration in effect, acts 'in loco parentis' for children and adolescents in state care, indeed they are the arbiter of who becomes a ward of the state, and who does not. When a child in state care is prescribed drugs and given the drugs without Informed Consent first being obtained from a parent; who is authorizing this be done?  If a child then sustains an iatrogenic, or "physician caused" injury, becomes disabled from the adverse effects of the drugs prescribed which have well-documented potential risks for causing chronic impairments and life-long disabilities; who is responsible? 3-year old drugged in TX
13 year old dies

I know the answer to that. No one is responsible, not the federally funded research psychiatrist, and not Children's Administration; the state pretends there is no need for accountability for harm done by agents of the state. It's impossible for me to pretend that professionals shouldn't be responsible for the harm they've carelessly caused my son.  My son is disabled as a direct result of the state's criminal negligence. According to one of the state's attorneys, the state fulfills some of it's mandated duties; but others require citizens to take legal action against the state. Not the most ethical perspective for a legal advisor responsible for ensuring state designees preserve the individual rights of their clients. This ineffective method serves more often to effectively deny a client any recourse once their rights are violated.  It's as if I've been informed DSHS employees are allowed to violate State and Federal Law, and are allowed to violate a client's individual rights in a Court of Law with impunity. When there is cause to believe crimes were committed, e.g. A well-documented written report detailing how 2 Officers of the Court and 2 mental health professionals used fraud and perjury as "evidence" in Superior Court obtaining a Court Order against a client who was seeking hopitalization---The state has a legal duty to conduct a criminal investigation on behalf of the victim.

After a criminal complaint was filed, the department  proceeded to deny it owes my son, any legal duty. The state has also proceeded to defend the criminal acts of it's designees, the Desigated Mental Health Professional, the psychiatrist, the Deputy Prosecutor, and the Assigned Counsel for the client. The state had a duty to refer a Criminal Complaint to Law Enforcement; and did not. I know I'm more than a little disgusted by the fact that public servants in the state's publicly funded social and mental health "service systems" are obviously enabled to routinely avoid being held accountable for their obviously negligent criminal conduct. I know that as a MadMother, it's more than horrifying to know there is no accountability for ethical and criminal failures of the people whom we entrust to protect children and vulnerable adults who are served by the social services "safety net."

It's not the veracity of the excuse offered in the AAG's message that most troubles me, it is the purpose of the message, i.e. to (again) deny any legal duty to a client victimized by the state's designees, no duty to investigate the Felony Crimes reported. My own perceptions are biased, but I believe my opinions are ethically and legally sound. The state's employees and it's assignees have repeatedly caused my son harm; and whether their actions were merely careless, or criminally negligent, the state enjoys an undeserved immunity. I know that no crime committed by public servants which victimized and injured  my son that I have reported has ever been investigated by Law Enforcement. That tells me that not filing legally mandated reports with Law Enforcement is the rule, not the exception--it explains why unethical behavior is so as common as it is...

There is no way in hell I will become complicit in the crimes which victimized my son. I believe to be silent in some instances is to be complicit. The major flaw in the accountability system for DSHS programs in this state, is that there isn't one. There is no accountability within DSHS; true accountability requires ethical integrity; it should not require a citizen having to take legal action against the state.

I've been living a nightmare for almost twenty years, virtually from the moment I discovered my son was victimized. My horror is compounded by the knowledge CPS had received several credible reports alleging children in the foster home my son was assaulted in, were being abused; prior to his placement there. The damage to my son has been further compounded by the criminal manner employees of the state and it's contracted "service providers" have "provided services" to my son and my family, more often than not, the services were not what was recommended or needed, and caused all of us further harm.
photo credit: weprocessweserve.com

Dec 27, 2012

I am Adam Lanza's Doctor by Rima E. Laibow, M.D.


Due to my disapproval of being linked to Barbara Hartwell's brand of "spiritual discernment"   
this post has been removed. 

Dec 24, 2012

Prosecute Psychiatrists


via the OC Register Letters to the editor:


Prosecute psychiatrists  
GARDEN GROVE, Clay Bock: The deadliest mass murder that has ever occurred in Orange County ends the lives of eight wonderful people, most of whom are in the prime of their lives. Hundreds of family members and their friends lives are terribly damaged forever after the loss of their loved ones. As it turns out, as in just about every one of these bizarre, brutal acts of violence, Scott Dekraai was in the hands of a psychiatrist and on psychiatric drugs. 

The second-deadliest O.C. mass murderer, according to the newspaper, Edward Allaway, also had a long history of psychiatric “treatment” before he killed seven people at Cal State Fullerton in 1976. There are hundreds of those treated by psychiatrists in between, including the man who killed innocent shoppers with the sword in Irvine or Eric Harris at Columbine.  
Psychiatrists know that these drugs cause a certain number of people to become violent. Here is a list of a few of the side effects for their drugs from the National Institute of Mental Health website: Irritability, aggressive or violent behavior, acting without thinking, extreme increase in activity or talking, sudden or unusual changes in behavior and even suicide.


If Dr. Conrad Murray can be prosecuted for Michael Jackson’s death due to misapplication of prescription drugs, it is time to prosecute psychiatrists behind these mass murderers. read here


Neuroleptic Origin: 1955–60;  French neuroleptique, equivalent to neuro- neuro- + -leptique < Greek lēptikós disposed to take, equivalent to lēp- (verbid stem of lambánein to seize) + -tikos -tic; see -lepsy  via Dictionary.com 

It is a relatively new concept for people with a diagnosis of schizophrenia to be considered "violent."  Violence has only been associated with a diagnosis of schizophrenia in the last 50 or so years----after the introduction of neuroleptic drugs.  It is significant that this shift in perception occurred around the time it became apparent that people treated with what were then, relatively new drugs, the neuroleptic, or "antipsychotic" drugs became aggressive or violent.   The neurological and cognitive impairment many attribute to the psychiatric diagnosis of schizophrenia are in reality caused by the teratogenic, neuroleptic drugs.

When one considers how little we know about the pathophysiology of schizophrenia for which these nerve-seizing or "nerve affecting" drugs were initially prescribed; it is more than a little frightening.  The neuroleptic drugs have been used for 60 years, and we know they cause cardio-vascular, metabolic and neurological dysfunction; we know that neuroleptics cause intellectual, neurological, cognitive and physical impairments, that are disabling; and can cause sudden or early death.  Neurological impairment was not identified as a symptom attributed to the progression of schizophrenia before the advent of these teratogenic drugs; but it is listed along with aggression and violence and now attributed to the diagnosis of schizophrenia; which seems less than acurate, or honest to say the the very least. 

via The Lancet:

“Why are the mentally ill still bearing arms?”

an excerpt:"As but one example, the second edition of the Diagnostic and Statistical Manual of Mental Disorders, published in 1968, redefined paranoid schizophrenia as a condition of “hostility” and “aggression” and projected anger in ways that encouraged psychiatrists to conceptualise(sic) violent acts as symptoms of mental illness." read           

In psychiatry, "successful treatment" is defined totally differently than in any other medical specialty. In psychiatry, successful treatment is not dependent upon diagnostic validity or the effectivenss of the treatment; it is solely based upon the patient's willingness to be "treatment compliant."

via the Journal of the Royal Society of Medicine, a personal paper asks, Does psychiatry stigmatize? The author concludes "psychiatry may have very little specific to offer" to many with a psychiatric diagnosis.  The paper asks whether it is possible that psychiatry harms some, and also agrees this is probably so, due to the limited ability to explain problems caused or exacerbated by social and environmental conditions.  read the paper here. 

via Reuters:

French psychiatrist sentenced after patient commits murder


A French psychiatrist whose patient hacked an elderly man to death was found guilty of manslaughter on Tuesday in a groundbreaking case that could affect the way patients are treated.
A court in Marseilles said Daniele Canarelli, 58, had committed a "grave error" by failing to recognize the public danger posed by Joel Gaillard, her patient of four years.

Gaillard hacked to death 80-year-old Germain Trabuc with an axe in March 2004 in Gap, in the Alps region of southeastern France, 20 days after fleeing a consultation with Canarelli at Marseilles's Edouard Toulouse hospital.

Canarelli was handed a one-year prison sentence and ordered to pay 8,500 euros to the victim's children, in the first case of its kind in France. Defense lawyers said the ruling would have serious repercussions for treatment of the mentally ill.

"If a psychiatrist lives in fear of being sentenced, it will have very real consequences and probably lead to harsher treatment of patients," said Canarelli's lawyer, Sylvain Pontier.

The court said Canarelli should have requested Gaillard be placed in a specialized medical unit or referred him to another medical team, as one of her colleagues suggested. Her stubborn refusal had equated to a form of "blindness", the court president Fabrice Castoldi said.

Gaillard had already been forcibly committed to a secure hospital on several occasions for a series of increasingly dangerous incidents.

The victim's son, Michel Trabuc, said he hoped the case would set a legal precedent.

"There's no such thing as zero risk, but I hope this will move psychiatry forward and, above all, that it will never happen again," he said.

Gaillard was not held responsible for his actions and was freed under medical supervision.

(Reporting by Jean-François Rosnoblet; Writing by Vicky Buffery; Editing by Alison Williams) here

Oct 4, 2012

Crespi Family Hope: An Antidepressant Side Effects Presentation

An Antidepressant Side Effects Presentation
Who:                The Crespi family and friends welcomes
David Carmichael to Charlotte, North Carolina
What:               An educational presentation on understanding medication-induced psychosis
and the Canadian legal system’s response to this tragedy
Where:            South Charlotte Banquet Center
9009 Bryant Farms Road
Charlotte, North Carolina  28277
Parking is plentiful and easily accessible
 When:              Thursday, October 11, 2012 at 7 PM
Why:                Due to the wide spread use of antidepressants, this informative presentation may benefit your family and friends and help prevent this type of tragedy from happening to someone you know
During this interactive session, David Carmichael will:
  • Show and discuss “Over the Edge”
  • Share his insight into his Paxil-induced psychotic episode
  • Explain how antidepressants may cause suicides and homicides
  • Discuss how to determine if someone might be experiencing antidepressant – induced psychosis
  • Facilitate a Question and Answer Session
More information is available at
Parental discretion is advised as the topic may be too sensitive for children.
The media is welcome.
via Huffington Post:

Kim Crespi Wants Husband David Crespi, 
Who Murdered Their Twin Daughters, Out Of Prison
Posted: 10/03/2012 3:00 pm EDT Updated: 10/03/2012 3:00 pm EDT

A man pleaded guilty to stabbing his twin daughters to death six years ago, but the girls' mother says he doesn't belong in prison.
Kim Crespi told WBTV that when the murders of five-year-olds Tessara and Samantha took place in North Carolina, her husband, David Crespi, was psychotic due the to multiple prescription drugs for anxiety, insomnia and depression that he'd recently begun taking.
"It wouldn't have happened without the prescriptions," she told WSOCTV. "David Crespi never acted like this ever in his life." read here

May 1, 2012

Plan to monitor ongoing harm done to foster children

DSM-1, 1952: 106 disorders
DSM-II , 1968: 185 disorders
DSM-III, 1980: 265 disorders
DSM-IV, 1994: 357 disorders

It appears that the Administration on Children, Youth and Families, 'ACYF' plans to continue allowing children in foster care to be drugged with psychiatric drugs even though there is ample evidence that this Standard Practice is not 'effectively treating' the psychiatric diagnoses the drugs are prescribed for.  The standard clinical practice of using teratogenic psychiatric drugs is not based on sound ethical medical principles, and is not supported with definitive empirical data showing the drugs to be safe or efficacious for use on children.  Using drugs which are not efficacious, that are known to be dangerous teratogens with fatal risks, without scientific evidence to validate the practice,  is Human Experimentation.  The plan to 'monitor' and provide 'oversight' of psychiatric drugs being used in what is essentially Human Experimentation on vulnerable foster children does not protect the children from further harm; this is a poor plan to say the very least...

This is not something that needs Federal 'oversight,' nor does it need to be 'monitored.' 
IT NEEDS TO BE STOPPED!

via The Policy Lab at The Children's Hospital of Philadelphia

April 30, 2012

New PolicyLab Research Expands Understanding of Psychoactive Medication Use Among Children in Foster Care

A few months after the federal Government Accountability Office (GAO) issued a report on the use of psychoactive drugs by children in foster care in five states, a national study from PolicyLab at The Children’s Hospital of Philadelphia describes prescription patterns over time in 48 states. The updated findings show the percentage of foster children taking antipsychotics--a class of psychoactive drugs associated with serious side effects for children-- continued to climb in the last decade. At the same time, a slight decline was seen in other psychoactive medication use, including the percentage of children receiving three or more classes of these medications at once (polypharmacy). here


via PR Newswire:
PRESS RELEASE
New research expands understanding of psychoactive medication use among children in foster care
a few excerpts:
"We're not saying these medications should never be used for children, but the high rate at which they're used by children in foster care indicates that other interventions and supports, such as trauma-based counseling, may not be in place for them. In other words, health care providers may not have other, non-medication, tools to offer families dealing with mental health concerns," said Rubin. "Responding to high and growing levels of antipsychotic use will not simply require efforts to restrict their use, but calls for larger investments in mental health programs that help these children cope with trauma psychologically."
"Prescription rates for both antipsychotic use and polypharmacy varied widely from state to state. Over the six-year period, antipsychotic use increased in all but three states. Conversely, 18 states showed an increase in polypharmacy, while 19 states showed decline and 11 no change. In 2007, states reported prescriptions of antipsychotics ranging from 2.8 percent to 21.7 percent of the foster care population, and from 0.5 percent to 13.6 percent for children receiving multiple classes of psychoactive drugs. The authors note, however, that it's not possible to use this study to compare states against one another.
"In illustrating both the national and state-specific trends in the use of psychoactive medications over time, we hope to provide a resource to officials at both the federal and state levels to help identify progress and prioritize intervention areas," noted Meredith Matone, MHS, a research scientist at PolicyLab who co-authored the study currently published online in the journal Children and Youth Services Review.
"Bryan Samuels, Commissioner of the Administration on Children, Youth and Families (ACYF), said "the study's findings contribute to ongoing Federal efforts to improve the oversight and monitoring of psychoactive medications by providing a new snapshot in time on how these drugs were used in almost every state in the nation." ACYF, part of the U.S. Department of Health and Human Services, works across federal agencies and with the States to use the latest data and research to design and deliver the best health care services for vulnerable children.(emphasis mine)
"In August, ACYF will bring child welfare, mental health, and Medicaid leaders from all 50 States, DC, and Puerto Rico together to address the appropriate use of psychoactive medications in state foster care programs." read here

Big Bucks Big Pharma


picture bonkersinstitute.org

Apr 15, 2012

Imagine: We have more in common than you realize

The brief phrases and sentences in quotation marks are those of a medical professional that I was fortunate enough to have a dialogue with.  I say 'fortunate,' because I can be abrasive and rude; I was during this conversation---However, the professional was willing to continue in spite of my rudeness...  The subject was the "off-label" prescribing of psychiatric drugs to children and the lack of Informed Consent.  


It is my opinion the reason the drugs are being so widely used is that Informed Consent is not happening a majority of the time.   The reason I have this opinion, is my own experience as the parent of a son who has been prescribed psychiatric drugs off label, and speaking to countless other parents who report the same experience and sense of betrayal due to not being informed of the known serious risks of the drugs by the medical professionals who prescribed them.  I sincerely doubt that so many children would be taking dangerous psychiatric drugs if parents were in fact being given appropriate, relevent unbiased information on both the diagnoses and the psychiatric drugs given to their child.


There is no doubt in my mind, that I would have never have consented to giving any neuroleptic, or 'antipsychotic' drugs to my son who was emotionally and behaviorally disturbed due to being the victim of a violent crime.  There is no way in hell I would have consented, much less, given him the drugs myself--IF I had been told what was known about the drugs at the time they were prescribed.  I had to learn through research I have done on my own....It is one of my greatest sorrows that in my ignorance, I made sure my son took the drugs prescribed... My overwhelming sense of betrayal is devastating; these drugs have caused my precious son further harm; and according to my son, further traumatized him.  The drugs have disabled my son; and there is no comfort in knowing that it is not my fault.  I relied on misinformation given to me by the prescribing medical 'professionals' who have acted unethically with impunity.


My opinions and observations on this topic should not be construed to be a judgement of the nameless professional quoted, or the quality of care the professional provides to patients---in truth, I know only that the conversation in fact occurred; and that it greatly disturbed me. 

" "off-label" use is legal and is not experimental use"


While "off-label"prescribing of the drugs is legal, the fact that a drug is being prescribed "off-label" means it has not been tested and approved for children and that fact is something a parent needs to be told in a dialogue which informs a parent about the nature of the diagnosis, what the potential risks, possible benefits, and what alternatives to the proposed drug are; including answering questions and providing additional sources for information in order to actually inform the parent.  Otherwise, it is not Informed Consent, but simply an assent.  What is happening in Real World practice is unethical, illegal and immoral:  Parents are not being fully informed, they are being misled, manipulated and coerced, by some.  

The fact is neuroleptic drugs have been in pediatric use for decades---without valid clinical research being the basis of this questionable practice.  Due to the lack of effectiveness, most patients are given one drug after another, or multiple drugs concomitantly attempting to find one or a combination of several which will alter or control an undesirable behavior.  Ultimately, professionals are treating a behavior, which is not life threatening, with drugs that cause iatrogenic injuries without sharing well documented risks, e.g. without Informed Consent. It is the very definition of human experimentation, covered under the US Code of Federal Regulations and International Law, i.e. the Nuremberg Code.  Calling it "off-label" prescribing, does not actually change the nature of what is being done; nor does it make what is being done in Standard Practice safe or ethical, or less experimental.  


Psychotropic drugs have the well known, documented risks of causing iatrogenic disabilities and sudden death.  The only plausible explanation for the prolific use of drugs with such serious risks being widespread is that Informed Consent is not in fact obtained.  It also explains why the parents whose children have been iatrogenically disabled or killed state that they had no idea their child could be disabled or die as a consequence of treatment.  Not fully informing patients or parents of the known risks inherent in treating non-life threatening psychiatric symptoms with drugs that have serious risks is unethical.  Failing to inform about these risks while telling both the child and the parent the drugs are treating a metaphorical disease to coerce compliance with treatment, is fraud.  Telling a person that a drug will effectively treat a mythological neuro-biological disease, that has never been identified is a deception intended manipulate a person's behavior when successful and detrimental to the patient, is the definition of criminal fraud...  


Not informing parents that the drugs alter normally functioning physiological processes none of which are known to be contributing to the undesirable behavior being treated while failing to inform of the risks for brain damage, heart damage, permanent neurological impairments, disability and death is Standard Practice.  Standard or not, this practice does not conform to the Ethical Guidelines for Informed Consent of the AMA; it violates a person's Constitutional Rights, and a Parent's Constitutional Right to make medical decisions for their child.  


"Not validated by thin air- but by extrapolation and empirical practice- much of medicine is still an art"


Since when does that mean people can be misled, coerced and manipulated in order to be 'effectively treated?'   The 'neuro-biological disease paradigm' that is being crammed down our necks, is derived from or more accurately survived the supposed end of the Eugenics movement.  All of the coercive manipulative psycho-education type of 'treatments' used in Standard Practice INCLUDING the Court Mandated treatment, using CPS, Police and the Courts is exactly how eugenics is done.  Here and now.   It was done in Germany by the Third Reich, it is also done, here and now, in this country.  


Lets remember, to be 'evidence-based' prescription practices for drugs treatment and recommendations for them should be derived from the Clinical Trial Data; not based solely on anecdotal evidence and a consensus of subjective opinions.   "Off label" prescriptions are (theoretically) to be based on some scientific empirical data. e.g. using a safe and efficacious drug to treat either a condition or a population for which the drug has not yet been FDA approved based on the fact that the drugs have been used effectively and safely to treat another diagnosis or population.  Off label prescriptions were not supposed to become Standard Practice just because prescribers have the 'legal' option! e.g. adult to pediatric use of drugs approved for adults or drugs approved for symptoms of psychosis prescribed to extinguish aggressive behavior.  In the case of neuroleptics, they are 'effectively treating' a minority of the patients who have psychosis for which the drugs were initially FDA-approved, a fact that should cause any reasonable person--including medical professionals to ask, "why are teratogenic drugs being used so prolifically and indiscriminately in Standard Clinical Practice?"


"TEOSS study- specific for early onset schizophrenia- doesn't account for use for atypicals 4 other diagnoses- eg mood disorders"


That is EXACTLY my point!  Clinical standard practices and treatment protocols are not based on clinical trial evidence!  Clinical trials are being conducted to validate standard practice already in use--which is backwards--and driven by the growing criticism of psychiatry's qquestionable claims and methods and the harm being done to people who permanently disabled and die as a result or it.


"you are citing ONE small study- extensive database on neuroleptics"


Apparently, without even realizing it, the doctor is making my point.  TEOSS doesn't account for the widespread use of neuroleptic drugs in the pediatric population; no studies do. There is no ethical medical rationale or evidence base supporting use of the drugs in the pediatric population, nonetheless, it has been standard practice for decades.  The purpose of the TEOSS Drug Trial was to validate the Standard Practice of using the the newer Atypical drugs as First Line treatment for early on-set schizophrenia; to show that the newer more expensive "Atypicals" were safer and more effective, than the older, cheaper drugs.  The results?  The newer drugs are not safer, nor are they more effective.  A small percentage of the patients were effectively treated--12%.   Significantly, the newer drugs tested in TEOSS were subsequently FDA approved for pediatric use based on research conduted in other countries...


How many parents whose children are given these drugs--for any diagnosis--are told that more than 1 but less than 2 out of 100 treated may die; or that 50 % percent of the children who take neurolepic drugs are expected to develop Tardive Dyskinesia, an untreatable neurological condition which can be permanent and disabling; even if the drug is stopped?  I have not met a single one yet!  I am appalled and totally disgusted when parents tell me of the high cholesterol, obesity, diabetes and heart issues their child has; yet are unaware that these are known adverse effects of the drug prescribed to their child! 


"Truth is about risk vs benefit-- no intervention in medicine is 100 % risk free"


Why is it that instead of responding to issues of Informed Consent and the lack of EVIDENCE justifying prescribing psychiatric drugs for behavioral or social problems using what are teratogenic drugs, every single medical professional I have encountered has avoided the issue altogether, or pointed out that there is no risk-free medical treatments? Rationalization and justification are avoidance techniques/behaviors.  Once a professional gets to the point that they cannot rationally put forth a valid argument defending their opinion; that is, an evidence-based defense for "off-label" prescribing of psychiatric drugs; or even validate the FDA-approved uses, it becomes crystal clear:  It is, it appears, because they NEVER considered that relying on "peer-reviewed" journals for information may mean they are misinformed!  If professionals rely on professional journal articles which offer a biased reporting of the data, and use Treatment Protocols and algorithms based on a consensus of subjective opinions instead of empirical data, they are not serving their patient's best interest. The reality is: the recommendations from psychiatry's expert consensus guidelines on the diagnosis and treatment of psychiatric diagnoses are rarely supported by empirical evidence of diagnostic validity or treatment effectiveness and safety; but do provide effective support to an extremely successful marketing agenda... 


I can understand why professionals would rely on these sources; however, in light of what is now common knowledge about the basis, e.g. validity, of these sources, it is unacceptable for professionals to continue to unquestioningly rely upon them.  Some professionals purposely avoid examining their own treatment of patients in this manner due to confidence in their peers; but patient trust and medical ethics are not built on a professionals confidence in their peers, or risk-free treatments.  It is based on ethically providing competent and therapeutic care with due diligence of duty.  Patients deserve to be told the truth about what their diagnosis is based upon, and factual information about the possible benefits and potential risks of the treatment their doctor is recommending!  When the patient is a child, their parents deserve to be given accurate information so that they can perform their sacred duty to protect their own child.


It is about the flawed trial designs, the incomplete, biased reporting of the evidence derived from clinical trials published in "peer-reviewed" professional journals that medical professionals rely upon.
It is also about using one's critical thinking skills, individual professional responsibility, and medical ethics.  It is about understanding and relying upon sound ethical principals to guide one's own professional assessment of relevant information.  Altogether, these flaws require that a professional  never assume that a "peer-review" process replaces the need for critical analysis of the actual scientific data. The INTEGRITY of the Medical Profession has been seriously damaged, and continues to be eroded by the American Psychiatric Association's failure to police the unethical conduct of individual members who continue to be considered Key Opinion Leaders.


The APA has failed to hold individual psychiatrists accountable; especially those whose outrageous violations of the Hippocratic Oath and their failure to use sound, ethical scientific standards when conducting academic research involving Human Subjects.  These same 'Lead Researchers" base Practice Parameters and Treatment Algorithms upon consensus of subjective opinions, not the empirical data derived from their own research.  These standards are supposed to be supported by subjective observations, and based on the data; not based on subjective opinions, and contradictory to the scientific data!  


It is a evident that the diminishing credibility of psychiatry is due to the laissez faire manner in which it develops it's 'standard practices,' and it's unwillingness to hold unethical researchers accountable, or even to retract research articles which have been discredited and invalidated from it's own 'evidence' base!  Ultimately, this blind-eye approach to the conduct of it's members, while continuing to rely on their seriously flawed methodology and corrupt work products is what continues erode trust, and fuel the loss of integrity of psychiatry as a medical specialty.  


Doctors who are medical specialists or generalists rely on the corrupt information generated by a relative few unethical psychiatric researchers; researchers who are well-funded and have serious conflicts of interest, and whose work often lacks validity; to their own patient's detriment.  This lack of professional integrity is not in any patient's best interest; and has an impact on every patient's best interest.
The regulatory failure in the FDA approval process, is due to conflicts of interest and the same ethical failures which infect academic research.  Another failure of the FDA however, ensures that some of the lax ethics in research and prescribing of psychiatric drugs are easier to dismiss and disguise; or worse, remain undiscovered rationalized and/or justified away.  The failure to which I am referring is the failure to require that Medical Professionals report adverse events, including death, to the AERS data base once a drug is FDA-approved.  The data from which one would more accurately assess risck/benefit of a particular drug.  It would be necessary to collect adverse events data from Real World clinical practice of FDA approved drugs...  Basing risk/benefit profiles solely of FDA-approved prescription drugs on the clinical trial data and anecdotal evidence is short-sighted, fundamentally flawed and NOT scientific.  It is no doubt contributing to the further corruption of the evidence base itself.  The data from Real World clinical practice is germane to both the efficacy and the safety of any and every FDA-approved drug.  This adverse event data is not being collected; it is not required of medical professionals to report it; and I, for one do not believe it is an 'oversight' or an 'accident.'

I have spent hours examining this data base, and what is frighteningly clear to me is that only a minority of the drug-induced deaths, drug induced iatrogenic illnesses and disabilities; and drug induced life-threatening emergencies listed are reported by medical professionals who prescribed the drugs which caused the 'adverse events.'  The majority of the deaths are  reported by attorneys or family members; not prescribers.   Another significant, morally reprehensible fact which is evidence of an ongoing tragedy and the numerous aforementioned regulatory and ethical failures; is the number of infants and children under six listed. 

a blessing and a hopeful prayer from the professional:
"We have more in common than you realize- 
transform that anger into passion for change- 
more sustaining and healing"

It is my sincere hope that we all come to know 
we have more in common than we are now aware of...
Imagine that...



 
first posted 12-9-2011photo credit

Feb 27, 2012

direct-to-consumer marketing of FDA approved drugs...

Whitney Houston's death has given the world another opportunity to look at FDA approved drugs in this country.  The 'news' reports are always biased; particularly when the death results from FDA approved drugs, but perhaps it is due to a Conflict of Interest---a whole hell of a lot of money is spent on direct-to-consumer marketing of FDA approved drugs...  


A couple of doctors minimizing the ethical responsibility of doctors and the FDA
NOT ETHICAL and NOT 'NEWS.'
It's just crappy journalism.

The doctor that killed Michael Jackson got a few freaking years in prison...The docs who prescribe multiple psychiatric drugs concomitantly even though prescribed concomitantly the drugs are KNOWN to be fatal, ineffective, or ill-advised; are allowed to continue "practicing medicine" after actually causing a recklessly causing a patient's death. Most deaths caused by the adverse effects of  psychiatric drugs are classified as "natural" deaths. Acts of violence, from FDA approved drugs,  including suicide and homicide, are rarely reported to the Adverse Events Reporting system...

via Plos ONE:

Prescription Drugs Associated with Reports of Violence Towards Others

a couple of excerpts:
Results
We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs.

Conclusions

Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional common features. here


This may explain why we have so many drugs on the market that are fatal:
The FDA is there to serve the drug industry, not the public says Dr. David Graham of the FDA




hat tip: PharmaGossip

LinkWithin

Related Posts Plugin for WordPress, Blogger...

FAIR USE NOTICE: This may contain copyrighted
(C) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.