Parents: Please Educate Yourselves About Psychiatric Drugs

What is the Scientific Basis of Psychiatric Treatment?

PLEASE EDUCATE YOURSELF ABOUT PSYCHIATRIC DRUGS

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

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

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

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

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

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

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

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

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

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

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

What is Informed Consent?

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

Informed Consent

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

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

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

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

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

mental illness is like any other illness? not in my family's American experience

I have wondered for years, why are reports and data from research paid for with Government Grants, is not readily accessible to the American people,  Is it because it is more difficult to defraud people when you put the actual information in front of them; not just the biased press releases and public service announcements developed by marketing departments?  Journalists, at one time used to independently verify information before "going with the story;" reporting the news.  There are studies conducted paid for by NIMH, and not published in this country.  How often is this happening?  It is not unusual, I have found.  In effect, the American people pay for research, and do not have ready access to the results.

Most of the research that is published here in the US is published in 'peer-reviewed' professional journals that restrict access.  Yet, we are expected to accept that the research was done correctly and ethically, our acceptance is to be based solely on a report, not the data itself. (reports can be biased and offered by someone with a Conflict of Interest)   Propaganda passes for news and press releases from marketing departments for 'news in the public interest.'  Major media news outlets use these press releases as 'news.' News can be reported along with a heavy dose of direct-to-consumer advertising for a product that is in the news. Biased reporting of medical studies being presented alongside copious direct to consumer marketing results in a seriously misinformed populace. Seems to me, it would increase the risk for harm.

It is a free country and any one who chooses to take the willfully blind and/or ignorant route is free to do so.  I am not one of them, and I am so totally outraged by how my family has been treated by people who are public servants and public employees, theoretically, working for us, but acting against us illegally at times, actually committing Federal Crimes, violating our civil rights.  Some public servants have committed perjury in Courts of Law, and retired with pensions.  These crimes were reported; and covered up,instead of being investigated or prosecuted.   I have been slandered and maligned by some of these people; so has my son.  In vain, I have desperately sought Justice for my youngest son; fought for my Constitutional Rights as a parent, and for my son's Human Rights as a trauma victim since 1993.  I have been treated with disrespect by public servants who have abused their authority and power people who have committed the felony crimes of perjury, forgery, Medicaid fraud. The worst of all, were those who medically neglected, tortured and physically abused my traumatized son, with impunity.  These events traumatized all of us--and disabled my brilliant son.

Jon McClellan, psychiatrist, "Quack Master Jack,"  i.e. the thug in a white coat who drugged my kid into a state of disability without Consent (Informed or otherwise).  He repeatedly told me I had NO SAY.  Quack Master Jack gets 1.8 million dollars bi-annually from the State of Washington.  I asked my State Senator and both State Representatives, to help me.  I have been given the silent treatment.  Good ol' boys, that I actually voted for.  I asked them to look into this knowing it is germane, I know that my concerns are valid.  The State of Washington's foster children, kids in treatment, in group homes and correctional facilities are not protected from the risks of the kind of iatrogenic harm that disabled my son.

Is it not a priority to protect children who are in the State's custody?

One of them the two representatives actually asked what I wanted him to do?!  I suggested he represent his constituents, namely my son, and myself.  I then suggested perhaps maybe the kids in state custody, even though they don't vote yet; are in need of his representation.  There are 47 children in Child Study and Treatment Center, consistently, at least 50 %, if not more are in fact Wards of the Court. Kids who do not have families involved to offer support, or Informed Consent.

My son spent more than 5 out of 10 years of his childhood in this facility.    He was "traumatized over and over and over;" it was none too easy on his brother and myself, I assure you.  He asked me in agony, "how could they take so much from me mom?"  I have no answer.  I know I will remember the sound of my child's terror-filled pleas echo in my memory for the rest of my life.  I know I tried to stop that prick.  I know I can not do anything to change what happened.  I know I have a duty to do whatever is in my power to stop it from happening to anybody else.

Kids who don't yet know that they have Constitutional Rights and that if these Rights are not defended, there is no equal protection under the law.  I bet a lot of those kids know they are not "protected."  I can't forget.

In Washington State, adolescents at the age of thirteen have the legal right to give consent for mental health services and substance abuse treatment.  Parental permission or consent is not required.  This law was passed to enable kids who have a desire to get help, who do not have their parent's support to get the help they need.  This law is in fact being used to exclude parents---in effect, denying parental rights to make medical decisions,  for their children.  This is happening in families who are not involved in "the system."   Reading the law it is clear to me that while it gives minors the right to consent to treatment--it does not diminish, or imply that a parent's Constitutional Rights are as a result diminished.

What is happening in real life is professionals are telling kids, "your parents do not need to be involved at all--we don't need them here.  You are old enough to make these choices for yourself."  In reality, an intelligent mature adult would have difficulty; since in order to provide Informed Consent, one needs to be given accurate unbiased information, and make a decision without being coerced.  Unless it is an emergency, a person is to have an opportunity to consult with others before receiving the prescribed "treatment" (drug or drugs)  Much of what is known about the drugs used for emotional and behavioral symptoms is based on a tainted and biased evidence base.  Rampant fraud and corruption in the FDA approval process and in the marketing of psychiatric drugs, puts everyone at risk.  It is obvious this law places children at risk. How many thirteen to eighteen year olds would know what kind of questions to ask about possible risks, potential benefits, and ask if there is anything besides drugs to help them? (that won't possibly cause dangerous negative effects, possibly disable them and/or cause their untimely death?) 


In the FDA AERs database, #574579 is Rebecca Riley, there is another 4 year old's death listed in 2007 from Seroquel--no gender is  listed and that is more that a little sad. A child who is reduced to a nameless, faceless statistic...I wonder did anyone cry over that child's death besides me?

How many kids (or parents) are actually told of the risk of fatality or heart damage from the drugs used to "treat" ADHD?  Are they told the drugs are in fact addictive, and that some have the same effect on the brain as illicit drugs?  Antipsychotics are being used for behavior control, for "bipolar" the most recent diagnosis de jour.  They are addictive, potentially disabling, and/or fatal; used as directed---even when the drugs appear to be 'helping' and are perceived as beneficial by the person taking them, used long term can cause serious iatrogenic diseases and brain damage.  I know this NOT because any psychiatrist or other mental health professional ever told me, but, because I made it my business to start researching when Quack Master Jack's behavior caused me to mistrust him.

Deceptive practices allow psychiatry and pharma to continue to do a smoke and mirrors snake oil medicine show with our psyches, our tax dollars, our Police, our Courts, AND our fundamental freedoms; our Human Rights.  Fraud, corruption and Human Rights crimes committed against individuals who are given a diagnosis. When diagnoses are adjudicated in Courts of Law, court procedures do not adhere to the same standards appplicable in any other court proceeding.  Civil Commitment laws virtually eviscerate the Rules of Evidence standard. The reason this is done is because diagnostic criteria and treatment standards rely on subjective opinions and are Standardized for clinical use by a quasi-democratic process. It is impossible to submit evidence in compliance with the Rules of Evidence that any psychiatric diagnosis is caused by a disease---such an attestation could not be supported with scientific evidence in compliance with the Rules of Evidence.

The treatment can be disabling or lethal...no biggie...at all.

NAMI says 'mental illness is like any other illness' 

A teacher in grade-school taught me about the Constitution of the United States of America. This document is gospel.  It is The American Gospel; it is why people seek refuge, and their own American dream here more than two hundred years after The Constitution was written.  I wonder... when I am once again struck by the injustice, the utter disregard for the law, and the manner in which our individual rights were neither preserved, nor defended; I (still) wonder, if I am naive?

I do not believe so.  I am grievously disappointed in my fellow man, and in My Country.  My sons and I are not victims; we are survivors.  The Constitution of the United States of America is Our American Gospel.  We know there just aren't enough people who understand exactly what is at stake.  We have elected representatives, and paid public servants who swear solemn oaths, yet fail to fufill their sworn duties.

It is a failure that has altered the course of my family's American experience.

"Whenever a doctor cannot do good, he must be kept from doing harm." 
Hippocrates


“Justice without force is powerless; force without justice is tyrannical.”  

Blaise Pascal

"Watch out for people who begin with another's concern to end with their own." 

Balthasar Gracian

"God grant me the courage not to give up what I think is right 
even though I think it is hopeless."

Chester W. Nimitz

The bible verse associated with my name

My Dad's Army Air Corps Unit's Motto

"Sustineo Alas" translation: "I sustain the wings"  

portions of this were first posted February 2011

Get Off Your Ass! (Ask Your Doctor if getting off your ass is right for you)

                                                                                

I

  Butt Drugs

first posted 4-21-2011
heart sweetcandi22 at photobucket

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

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

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

The drug was not FDA approved when 

Traci Johnson killed herself.

The FDA approved Cymbalta to treat depression in August 2004

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

Jeanne Lenzer reports via Slate Magazine: 

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

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

More than a dozen bodies were buried in order to enable 

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

more from Slate:

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

This is the legal definition of fraud:

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

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

The certain required features:

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

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

The definition of metaphor:

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

via Mad in America Rethinking the Broken Brain: 

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

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

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

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

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

read here

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

via Phil Lawrence, NUMB a documentary director on youtube:

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

via The Alliance for Human Research Protection:

Vera Hassner Sharav, M.L.S.

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

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

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

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

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

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

snake oil image from businesspundit.com 

new addition to websites I like rxisk.org

 Bobby Fiddaman said it perfectly:

"Forget the MHRA, FDA and Health Canada. All three have a proven track record of failing to protect the public from the dangers of drugs, in particular psychiatric drugs."

"The adverse reporting systems on the websites of the regulators mentioned above leave a lot to be desired. They are old, out of date and are rarely followed up."

"All three are paid by the pharmaceutical industry, all three have revolving doors for ex pharmaceutical employees, all three have failed in their duties to safeguard human health." (emphasis mine)

via rxisk.org 

About Us

• Why RxISK.org?
• Why Should You Report?
• Our Mission
• Our Medical and Research Team
• Our Business Team
• Contact Us

Why RxISK.org?

Prescription drug safety is an issue for us all.

Adverse side effects from these drugs are now a leading cause of death. And yet experts estimate that only 1–10% of “serious” adverse events (those that lead to hospitalization, life threatening, disability, congenital abnormality, and death) are ever reported. Not to mention the millions of “medically mild” adverse drug events that occur each year — ones that compromise a person’s concentration, functioning, judgment, and ability to care.

RxISK.org, the first free website (not sponsored by big pharma or advertising) for patients and their doctors and pharmacists to research, and more importantly, easily report drug side effects.

Why Should You Report?

No one knows drug side effects like the person who is taking a pill. Yet this voice is not heard. RxISK.org provides a megaphone to you and your healthcare team to change the way we see drug safety.

You may have been told there is no evidence linking the treatment you are on to the problems you are experiencing. One reason there may be no evidence is because you and your doctor have been silenced. Most of the data on prescription drugs is “owned” by the multinational pharmaceutical companies who run 90% of all clinical drug trials — and they’re not sharing data that may affect their bottom lines. And, as mentioned above, only 1-10% of serious adverse events are reported to the FDA.

There is definitely a gap in the data — and we need data for Data Based Medicine.

This is where you and your doctor and pharmacist come in.

We encourage you to use RxISK.org to research prescription drugs and their side effects. But please consider also reporting your side effects. Not only will you be helping yourself — by receiving your free RxISK Report™ to take to your doctor or pharmacist — but you will also be helping others, by adding your anonymized experience to the data on prescription drugs.

RxISK.org is your website to help make medicines safer for all of us.

Our Mission

“We’ve talked about it – and now we’re doing something about it.”

Our goal is the early identification of potential adverse drug events and other treatment-related effects through a unique approach to data collection and analysis.

We believe RxISK.org will succeed because of

• patients’ desire to have their situation considered by a site backed by an expert team;
• a commitment to the truth, with no bias;
• the necessary level of expertise in designing and interpreting patient information as it expands beyond simple yes-no answers; and
• a single focus — that is, effective adverse-drug-event reporting must be the main mission, not a secondary one.

This will result in a collection of patient and medical narratives, including economic and quality of life information, that will establish the nature of treatment-related effects, the best methods to manage them, and their potential to form a basis for new drug discovery.

Now that the truth about such medications as Vioxx and Avandia has reached the public sphere, the general public is suspicious of messages from drug companies. Appetite for a credible independent perspective based on the voice of the patient is strong.

Our Medical and Research Team

There are few professionals who have the profile and international reputation of Data Based Medicine’s founding team, which includes people who have risked their careers in speaking out about adverse drug events, such as David Healy and Nancy Olivieri, as well as international experts on pharmaco-vigilance such as Ralph Edwards from World Health Organization’s Uppsala Monitoring Center.

Dr. David Healy, Chief Executive Officer and principal founder of Data Based Medicine Limited, is an internationally respected psychiatrist, psychopharmacologist, scientist, and author. A professor of Psychiatry at Cardiff University in Wales, David is a former Secretary of the British Association for Psychopharmacology, and has authored more than 150 peer-reviewed articles, 200 other pieces, and 20 books.

David has been involved as an expert witness in homicide and suicide trials involving psychotropic drugs, and in bringing problems with these drugs to the attention of American and British regulators, as well raising awareness of how pharmaceutical companies sell drugs by marketing diseases and co-opting academic opinion-leaders, ghost-writing their articles. His latest book, Pharmageddon, documents the riveting and terrifying story of how pharmaceutical companies have hijacked healthcare in America and the life-threatening results.

He also publishes through his blog DavidHealy.org and on Twitter @DrDavidHealy.

Dr. Derelie Mangin is Professor and Director of Research in the Department of Public Health and General Practice in the University of Otago in New Zealand and an expert advisor to the NZ government on drug treatment funding priorities.

Dr. Kalman Applbaum is Professor of Medical Anthropology and Global Studies at the University of Wisconsin. He is a pharmaceutical industry expert and former marketing professor at the Kellogg School of Management.

Dr. Ralph Edwards was Director of the Uppsala Monitoring Centre (UMC) from 1990 to 2009. UMC is a World Health Organisation (WHO) collaborating centre for international drug monitoring located in Sweden. Under his management, revenue grew to in excess of US$40m. He has been President of the International Society of Pharmacovigilance (2000-2004) and is among the world’s leading experts on pharmaco-vigilance.

Dr. Brenda Gallie is Director of the Retinoblastoma Program at The Hospital for Sick Children, and Professor of Ophthalmology, Molecular Genetics, and Medical Biophysics at the University of Toronto. Her research has revealed basic molecular processes in cancer. She has developed a time-line for medical adverse events to enable patients and doctors to better understand how the adverse event might have evolved — this is incorporated into RxISK.

Robert Whitaker is the founder of Centerwatch (in 1994), an early provider of market intelligence on pharmaceutical companies for investment analysts and others. He is the author of Mad in America and Anatomy of an Epidemic, which analyze the consequences of the indiscriminate use of medications. Robert also publishes through his blog, Mad in America, and on Twitter @WhitakerRB.

Dr. Joanna Le Noury is Senior Research Scientist in the North Wales Department of Psychological Medicine; she has analyzed several large pharmaceutical databases in the course of litigation.

Dr. Nancy Olivieri is a Senior Scientist at Toronto General Hospital, and a Professor of Pediatrics, Medicine, and Public Health Sciences at the University of Toronto. Her work explores the role of the pharmaceutical industry in society, and its influence on research and on the evidence base of medicine.

Our Business Team

Peter Wood, FCA, is an Ernst & Young retired partner with expertise in tax, corporate management, and leading-edge technology who has developed several successful web-based businesses. We are fortunate to have Peter leading our business team of operations, finance, marketing, technology, and design professionals.

Contact Us

To contact us, please email: Info@RxISK.org