Bought and Paid for FDA approved Risperdal leaving many to suffer

RISPERDAL:

The drug was approved, by the FDA, for public use in 1993, to treat schizophrenia, a “mental disorder” for which there is no defining diagnostic test. No blood test, no saliva test, no brain scan, no genetic assay.

In 2006, the FDA approved Risperdal to treat “irritability” in autistic children. There is no defining diagnostic test for autism. The neurological damage involved can come from any cause—especially vaccines. But of course, all public health agencies deny this fact. 

In 2007, the FDA approved Risperdal to treat bipolar disorder in children between the ages of 10 and 17. Bipolar is another “mental disorder” for which there is no defining diagnostic test.

Risperdal was approved to treat three conditions, which are diagnosed by casually observing a patient’s behavior and comparing it to a menu of behaviors called schizophrenia, bipolar, and autism.

If the drug had no adverse effects, that would be one thing; but it has devastating effects. Tardive dyskinesia, a permanent “movement disorder” that signals brain damage. Suicide. Gynecomastia—boys grow female breasts.

The lawsuits against Johnson & Johnson, Risperdal’s manufacturer:

2012: J&J fined $1.2 billion for hiding adverse effects of the drug. Decision overturned on appeal.

 

2012: J&J paid out $181 million for actively promoting off-label uses for Risperdal. Doctors are permitted to prescribe a drug for unapproved uses, but drug companies cannot legally promote or urge doctors to wander into that off-label territory.

2015-2016: There are at least 1500 suits against J&J for causing boys to grow female breasts. Thus far, three verdicts have been decided in favor of the boys, for $1.75 million, $2.5 million, and $70 million.

The story of Risperdal expands and explodes when we consider the marketing effort behind it. Basically, the hustle involved claims that the drug could be used to treat a wide array of so-called disorders in children.

I will now quote extensively from a classic article written at madinamerica.com, by Paula J Caplan, PhD. The title of her article (10/30/2015) is “Diagnosisgate: A Major Media Blackout Mystery”:

“Until their identities are widely exposed, and their motives are known, the full story of the [Risperdal] harm will never be known. It is astonishing that despite six stories in the major media — including a recent, groundbreaking Huffington Post series — and the filing of numerous lawsuits, the names and conduct of the culprits have consistently been omitted.”

“The story that has been called ‘Diagnosisgate’ starts in 1995, when the man widely considered the world’s most important psychiatrist split a payoff of nearly one million dollars with two colleagues in exchange for doing two patently unethical and illegal things that created the groundwork for a major drug company to market falsely one of the most dangerous psychoactive drugs [Risperdal].”

“Part one: In return for almost half a million dollars, they ignored what was known about the drug [Risperdal] in order to manufacture a practice guideline holding up that drug as the best drug among two whole classes of related drugs for treating people who were classified as ‘schizophrenic,’ the other drugs being marketed by other drug companies. This created what is widely considered the ‘standard of care,’ the treatment that therapists are supposed to follow and that they can use in the knowledge that they are well protected from lawsuits if they follow it and their patients are harmed. The very foundation of the guideline, that it was about ‘Schizophrenia,’ is illegitimate, because – though this will surprise many people – that category has been shown to be unscientifically created and indeed has been called a wastebasket for a wide variety of feelings and behavior, many of which are caused by psychiatric drugs.” 

“Part two: After the triumvirate received a bonus of $65,000 for creating the guideline [‘treat schizophrenia with Risperdal’] speedily, their top psychiatrist wrote to the same drug company, announcing that the three had constituted themselves as an entity that was prepared, in return for about another half million dollars, to create a marketing plan for the drug. The details included finding ‘key opinion leaders’ (KOLs), who were prominent professionals in powerful positions – such as heads of state mental health or prison systems – and having them teach the Continuing Education courses that professionals are required to take, the ultimate message of those courses being that that particular drug [Risperdal] was the best one to prescribe. Another section of their marketing plan was to have a great many articles published in what are considered scientific or medical journals, all concluding that that drug was effective and should be prescribed.”

“It is not clear whether the three psychiatrists were directly involved in choosing the content of the journal articles, but the plan to produce such articles was carried out, leading to publication of pieces recommending use of the drug [Risperdal] to treat not only Schizophrenia but also Childhood Onset Schizophrenia, Schizo-affective Disorder, Bipolar Disorder in Children and Adults, Mania, Autism, Pervasive Developmental Disorder other than Autism, Conduct Disorder, Oppositional Defiant Disorder, Psychosis, Aggression Agitation, Dementia, below average IQ, and disruptive behavior. Thus, a staggering array of psychiatric categories – many of which are as scientifically sketchy as Schizophrenia – was used to promote the drug. This massive marketing campaign proceeded despite the many major negative effects of Risperdal, including drowsiness, dizziness, nausea, vomiting, diarrhea, constipation, heartburn, dry mouth, increased saliva production, increased appetite, weight gain, stomach pain, anxiety, agitation, restlessness, difficulty falling asleep or staying asleep, decreased sexual interest or ability, vision problems, muscle or joint pain, dry or discolored skin, difficulty urinating, muscle stiffness, confusion, fast or irregular pulse, sweating, unusual and uncontrollable movements of face or body, faintness, seizures, Parkinsonian symptoms such as slow movements or shuffling walk, rash, hives, itching, difficulty breathing or swallowing, gynecomastia in male children, painful erection of penis lasting for hours…and death.”

 

“Who are the characters in this mystery? Janssen Pharmaceuticals, a division of Johnson & Johnson, is the drug company, and Risperdal is the drug in question. The marketing term for Risperdal and similar drugs is ‘anti-psychotic,’ but the accurate term is ‘neuroleptic,’ reflecting the mechanism of suppressing the brain’s activity as a powerful tranquilizer. Dr. David Rothman, who wrote the expert witness report for one of the lawsuits about the marketing of Risperdal, revealed after scrupulous examination of vast numbers of internal emails between Janssen staff and the representative of the three psychiatrists, is a specialist in medical ethics and the Bernard Schoenberg Professor of Social Medicine at Columbia College of Physicians and Surgeons, the medical school of Columbia University. He is also director of the Center for the Study of Science and Medicine at Columbia and at the time of writing his expert witness report was president of the Institute on Medicine as a Profession. Rothman stated in his report that the [treatment] guidelines [for Risperdal] were constructed ‘in disregard of professional medical ethics and principles of conflict of interest,’ and that they ‘subverted scientific integrity, appearing to be a purely scientific venture when it was at its core, a marketing venture for Risperdal’.”

“The psychiatrist who spearheaded these [Risperdal marketing] efforts is Dr. Allen Frances, who the year before teaming with Janssen oversaw the publication of the fourth volume of the ‘Bible’ of hundreds of categories of mental illness, Diagnostic and Statistical Manual of Mental Disorders, sales of which topped $100 million as a result of marketing by the lobby group called the American Psychiatric Association, which published it. By virtue of this position, he has been called the world’s most important psychiatrist. At the time, he was also Chair of the Department of Psychiatry at Duke University. The two psychiatrists who with Frances shared the nearly $1 million in payments from Janssen are Dr. John P. Docherty, who was then Professor and Vice Chairman of Psychiatry at Cornell University at the time, and Dr. David A. Kahn, who was Associate Clinical Professor of Psychiatry at Columbia University.”

 

“Now back to the mystery: Despite five individual stories in major media outlets in 2011, 2012, and 2014 about two huge Risperdal court cases filed by the state of Texas and joined by many other states, neither a single writer of any of these stories nor even the papers filed for the court cases named Frances, Docherty, or Kahn or described the fundamental roles played by their Practice Guideline and their marketing plan in the scandal. The mystery is deepened, because the authors of the media stories and the court documents did name and describe the roles of some of the KOLs [key opinion leaders], who assuredly were guilty of unethical conduct but whose participation was conceived of by Frances and his colleagues. And some of those who reaped huge financial profits from Risperdal’s false marketing – most notably Harvard University’s Dr. Joseph Biederman, who created an empire based on claims that ‘Bipolar Disorder in Children’ had been woefully underdiagnosed and untreated – have been royally outed for the enormous sums they earned. But even respected investigative journalist Steve Brill, who recently completed a unique, 15-part story of the Risperdal scandal for Huffington Post, and who described in detail many of its players and some of the patients who suffered terrible harm from the drug and who elegantly described the way that Janssen covered up data about some of the harm, left out the essential roles the Frances triumvirate played. Activist Vera Sharav of the Alliance for Human Research Protection published an online article about the Rothman Report and included the names of Frances and those two colleagues, her article was apparently picked up by only two or three bloggers and none of the major media reporters who read what she posts.”

There is more. Much more. I suggest you read Caplan’s entire article. In a half-sane world, she would have been awarded the highest possible honors for her work.

Risperdal. The long and winding trail. The severe damage. The hustle, the con. The crimes.

The lack of criminal prosecutions.

Brought to you by high authorities in the psychiatric profession and their allies.

 

 

repost:https://jonrappoport.wordpress.com/2017/05/09/risperdal-the-long-and-winding-trail-of-crimes/