The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Wyeth Paid For Positive Articles On Their Drugs In Journals

December 13, 2008

http://www.dbtechno.com/health/2008/12/13/wyeth-paid-for-positive-articles-on-their-drugs-in-journals/

Filed under: Charles Grassley, Wyeth

Upcoming Radio: Amy Philo Speaks Out About Ray Sandford, Forced ECT & The MOTHERS Act

This Saturday, Dr. Rebecca Carley’s “What’s Ailing America” radio program will be devoted to Ray Sandford and forced electroshock.

Amy Philo will be interviewed during the first half of the show about the “treatment” received at Mercy Hospital in Coon Rapids, MN, where she was an involuntary patient in 2004. Ray Sandford is being forcibly taken to Mercy for weekly ECT sessions.

For more information about Ray’s case, check out: http://www.mindfreedom.org/shield/ray/sandford-faq or listen to NPR’s coverage of the Ray Sandford campaign at: http://www.npr.org/templates/story/story.php?storyId=98273451

David W. Oaks, director of MindFreedom International, is scheduled to be on “What’s Ailing America” during the second half, and anyone can call in.

Call In Number: 800-313-9443
Show Time: Saturday, January 3, 2009, 3:00 PM – 5:00 PM Eastern

To listen, when the show begins click: http://republicbroadcasting.org

The following Wednesday, January 7, Amy Philo will be interviewed on The Mental Health Edge radio program about The MOTHERS Act.

WTAN AM, 8:00-9:00 p.m. Eastern
Call the SHOW HOTLINE: 727-441-3000
Listen to the show online: http://tantalk1340.com/

Filed under: ECT, MindFreedom, Psychiatry: Force of Law, Ray Sandford, , , , ,

Antipsychotics Virtually Unfit for Human Consumption

FRED A. BAUGHMAN, JR. M.D.*
NEUROLOGY AND CHILD NEUROLOGY (Board Certified)
FELLOW, AMERICAN ACADEMY OF NEUROLOGY

fredbaughmanmd@cox.net
1303 HIDDEN MOUNTAIN DRIVE
EL CAJON, CA 92019

Tele:(619) 440-8236 Fax: (619) 442-1932

Submission (2 essays) to: December 21, 2008

The Florida Agency for Health Care Administration concerning the Medicaid
coverage of atypical antipsychotics on children [http://ahca.myflorida.com/docs/AdHocWebCancellationMessagev2.pdf]

(1) Neurological Side-Effects Contraindicate Use of Antipsychotics In Children

(450 words)

Fred A. Baughman Jr., MD

Author: THE ADHD FRAUD—How Psychiatry Makes “Patients” of Normal Children

http://www.Trafford.com

As an adult and child neurologist (retired) the neurological complications of psychiatric drugs, especially the typical and atypical antipsychotics (Zyprexa, Risperdal, Seroquel, Abilify, Geodon), comprised a significant part of my practice. Referring psychiatrists rarely diagnosed or much understood the neurological side effects of the drugs they were prescribing.

I encountered transient and permanent dyskinesias (when permanent and irreversible we call them “tardive” dyskinesias). There was acute and chronic torticollis. There were acute oculogyric crises (forced version of the eyes, more often upward than to one side or the other). I encountered eye-blinking and forced eye closure, wrongly called “Tourette’s syndrome” –not idiopathic at all, but iatrogenic. There were acute and chronic, always-embarrassing, oral-lingual-facial dyskinesias. There were Parkinson’s syndromes needing differentiation from idiopathic Parkinson’s disease. There were rare cases of bulbar paralysis or bulbar dyskinesia leading to aspiration, pneumonia, and death–especially in the elderly, especially in nursing homes, in bed. There were strokes related to the start of dosing. Most frequent of all were the tardive dyskinesias, those appearing after months or years on antipsychotics, never abating, grotesque, embarrassing and sometimes so persistent and severe, especially in the elderly that they grew exhausted and died.

I almost forgot neuroleptic malignant syndrome–NMS, usually lethal as its name suggests, not to be confused with the clinically similar “serotonin syndrome,” due to an entirely different group of psychiatric drugs, the SSRIs. My list of the neurological side effects is short and incomplete, but it is a list all neurologists are well aware of, and all physicians prescribing such medications should be aware of, but are not.

Why haven’t neurologists (American Academy of Neurology, American Neurological Association, Child Neurology Society) , knowing fully the neurological horrors of antipsychotic drugs spoken up as these same grotesque, disabling and sometimes-lethal side effects are visited, today, upon the children of the nation, entirely for psychiatric indications–not actual diseases at all [Concern About Psychotropic Drugs and Foster Kids http://www.psychiatrictimes.com/display/article/10168/1167042#%5D. It is one thing for adults to opt to take such medication, it is quite another, as across the US today, for psychiatrists and physicians of all kinds to place entirely normal children on antipsychotic drugs. This should not be allowed.

I have not expounded upon the many somatic side effects of these drugs such as the morbid obesity, hypercholesterolemia, hypertriglyceridemia, hypertension, diabetes, gynecomastia (often needing surgical reduction), and prolactin-secreting tumors of the pituitary. I have not mentioned them previously because it is my conviction that the neurological side effects alone constitute reason enough not to the use antipsychotic drugs in children.

Whether the child has one or several “chemical imbalances” of the brain and is entirely normal, or has a diffuse encephalopathy manifested by mental and/or motor retardation, prescription antipsychotics, with all of their side effects are nothing but symptomatic “treatment”—symptomatic treatment that comes at far to high a price for any physician to justify. Putting neurologically-, medically-normal children on antipsychotic drugs is criminal and is an act that needs criminalizing.

(2) FRED A. BAUGHMAN, JR. M.D.
NEUROLOGY AND CHILD NEUROLOGY (Board Certified)
FELLOW, AMERICAN ACADEMY OF NEUROLOGY
fredbaughmanmd@cox.net
1303 HIDDEN MOUNTAIN DRIVE
EL CAJON, CA 92019

Tele:(619) 440-8236 Fax: (619) 442-1932

Editor, Lewis P Rowland, MD June 25, 2006
Neurology Today (American Academy of Neurology)
Editorial Office
333 Seventh Ave.
New York, NY 10001
NeuroToday@LWWNY.com

In News From the World Parkinson Congress; Epidemiology and Neuroprotection (published: Neurology Today, 4/18/06 p 36), Caroline M. Tanner, MD, PhD says that the Parkinson’s Disease risk is usually about twice as high in those exposed to pesticides and herbicides such as rotenone, paraquat, and diquat, but that only one toxin, MPTP (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine), has been proven to cause PD.

How could she not mention the neuroleptic/antipsychotic drugs, new and old, atypical and typical, which commonly (in every neurology practice) cause a form of PD clinically indistinguishable from idiopathic PD (in addition to facial-lingual muscle spasms, dystonias, dysphagia, oculogyric crises, torticollis, retrocollis, akathisia, facial, lingual, buccal, and cervical dyskinesias and the oft-fatal neuroleptic malignant syndrome).
We should all be outraged that antipsychotic drug prescriptions are increasing so for pediatric patients [NEW YORK (Reuters Health) Jun 05 2006 - The prescription of antipsychotic medications for children and adolescents in the US increased nearly 6-fold between 1993 and 2002, according to survey results. Also, Arch Gen Psychiatry 2006;63:679-685]. Eighteen percent of visits to psychiatrists by young people resulted in their being prescribed an antipsychotic medication. Approximately 90% of antipsychotics prescribed were for the second-generation, atypical, drugs — clozapine, risperidone, olanzapine, and quetiapine. What’s more, none of these drugs are approved for treating adolescents or children. They were prescribed primarily for disruptive behavior disorders (37.8%)– ADHD, conduct disorder and oppositional defiant disorder—none actual diseases; mood disorders (31.8%)—none actual diseases; 14.2% for psychotic disorders—none actual diseases, and pervasive developmental disorders or mental retardation (17.3%).

In a survey of antipsychotic drug use in youth (Science News, February 24, 2004, Vol. 140) 33%, developed a PD-like syndrome, while an eighth, treated for three months or more, developed tardive dyskinesias.

All antipsychotic/neuroleptic medications, old or new, typical or atypical are potent brain/body poisons. They should be used in psychotic, neurologically normal, children, for the shortest periods possible. Their long-term use is often justifiable in those who are severely to profoundly mentally subnormal, where necessary to keep them from harming themselves or others. They should never be used in neurologically normal children otherwise.

In general, the psychiatric drugging of millions of medically-, neurologically-normal children in this country, for unfounded, unscientific, claims of psychiatric “disorders”/”diseases”/ “chemical imbalances” is a monumental fraud and a national disgrace.

Sincerely,

Fred A. Baughman Jr., MD
Fellow, American Academy of Neurology

Filed under: Uncategorized,

“Get Off The Pharm”

The coolest rap song of all time, and might I add that those are some mad rhymes.

Lyrics

MP3

Filed under: pharmacology, , , ,

German Documentary on SSRIs To Be Broadcast

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

FYI On Tuesday, December 9, German TV ZDF will broadcast a hard hitting documentary about corrupt pharmaceutical company practices. One issue that will be addressed for the first time is: Why did the German drug regulatory agency (BGA) approve Prozac in 1991 after denying Eli Lilly the license to market the drug in Germany in 1984 without explicit label warnings about the increased suicide risk the drug poses?

May 25, 1984 Internal memorandum from Eli Lilly regarding the company’s efforts to obtain a marketing license for Prozac in Germany states: “During the treatment with the preparation [fluoxetine] 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation in the sence (sic) of an deterioration of the clinical condition, which reached its lowest point.” [PZ281]

Furthermore, Lilly’s own documents reveal that a 1988 review of clinical trials found that 38% of patients taking Prozac compared to 19% of patients on placebo experienced “activation,” which is linked by the FDA in current labeling to violent and suicidal behavior. [PZ-477].

See: Eli Lilly internal documents: What do They Reveal? http://www.ahrp.org/infomail/05/01/27.php

BZ281: Lilly Memo, Keitz; Bad Homburg to Corporate Headquarters, May 25, 1984, with Comment on Clinical Documentation Fluoxetine from BGA (Germany) rejecting Prozac for marketing.

PZ-477: Lilly Memo. Activation and Sedation in Fluoxetine Clinical Trials, 1988

See: Lenzer, J. FDA to Review “Missing” Drug Company Documents, BMJ (formerly British Medical Journal), January 1, 2005. http://bmj.bmjjournals.com/cgi/content/full/330/7481/7

Contact: Vera Hassner Sharav

veracare@ahrp.org

212-595-8974

 

From: Lothar Schröder [mailto:lothar1962@googlemail.com]

Sent: Saturday, December 06, 2008 6:32 AM

To: veracare@ahrp.org

Subject: German TV-Documentary on SSRI and psychotopic Drugs

Dear Vera, since the death of my wife I am trying to inform the German public about the risk and dangers of SSRI-antidepressants. My wife took ZOLOFT 3 years ago for only 11 days. Two days before her death the medication was stopped abruptly. A few months after her death the European Commission made it mandatory for European license holder of SSRI- antidepressants to include a warning about the risk of suicide for children and adolescents in the product information and package insert. Before it, the risk of suicide was not even listed in the product information and package insert.

I have tried to press criminal charges against Pfizer but the German courts have put it down. I have also informed the media about it. Now next Tuesday (09. December 2008, 21:00 hour German time on ZDF) the German TV ZDF will broadcast a documentary about the criminal practices by the big pharmacy companies to press the SSRI antidepressant to the European market. The German regulatory agency BGA (Bundesgesundheitsamt) knew about the risk of suicide of the SSRI Prozac and refused to admit it to the German market: first in 1985 and then 3 years later in 1988. But finally Prozac was admitted to the German market in 1991. Zoloft and the other SSRI antidepressants followed.

Last Tuesday, Frontal 21 has broadcast a 6-minute long report about Prozac and Zoloft (see: http://frontal21.zdf.de/ZDFde/inhalt/19/0,1872,7486227,00.html).

I hope that this report and the documentary will put real pressure on our politicians and on our regulatory agency. Why was Prozac approved in 1991 although the german BGA knew about the risk of suicide since 1984? Maybe you want to inform the readers of your infomail – I am one of them for many years- and in your blog about the documentary. It will be seen in all German speaking countries in Europe. Thank you very much.

Best regards,

Lothar Schröder 

Filed under: suicide, Zoloft, , , , ,

Massachusetts General Hospital Research Center Tied to Drug Company

November 25, 2008
The New York Times
Research Center Tied to Drug Company

By GARDINER HARRIS
http://www.nytimes.com/2008/11/25/health/25psych.html?_r=1


When a Congressional investigation revealed in June that Dr. Joseph Biederman, a world-renowned child psychiatrist, had earned far more money from drug makers than he had reported to his university, he said that his interests were “solely in the advancement of medical treatment through rigorous and objective study.”

But e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to “move forward the commercial goals of J.& J.” The documents also show that the company prepared a draft summary of a study that Dr. Biederman, of Harvard, was said to have written.

Dr. Biederman’s work helped to fuel a fortyfold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children.

Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions.
Massachusetts General said in a statement Monday that it took the accusations related to the research center “very seriously” and intended “to investigate these issues thoroughly.”

Johnson & Johnson makes a popular antipsychotic medicine called Risperdal, or risperidone. More than a quarter of its use is in children and adolescents.

Last week, a panel of federal drug experts said that medicines like Risperdal were being used too cavalierly in children and that regulators must do more to warn doctors of their substantial risks. Other popular antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify, made by Bristol-Myers Squibb.

Thousands of parents have sued AstraZeneca, Eli Lilly and Johnson & Johnson, claiming that their children were injured after taking the medicines; they also claim that the companies minimized the risks of the drugs.

As part of the lawsuits, plaintiffs’ lawyers have demanded millions of documents from the companies. Nearly all have been provided under judicial seals, but a select few that mentioned Dr. Biederman became public after plaintiffs’ lawyers sought a judge’s order to require Dr. Biederman to be interviewed by them under oath.

In a motion filed two weeks ago, lawyers for the families argued that they should be allowed to interview Dr. Biederman under oath because his work had been crucial to the widespread acceptance of pediatric uses of antipsychotic medicines. To support this contention, the lawyers included more than two dozen documents, among them e-mail messages from Johnson & Johnson that mentioned Dr. Biederman. A judge has yet to rule on the request.

The documents offer an unusual glimpse into the delicate relationship that drug makers have with influential doctors.

In a November 1999 e-mail message, John Bruins, a Johnson & Johnson marketing executive, begs his supervisors to approve a $3,000 check to Dr. Biederman as payment for a lecture he gave at the University of Connecticut.

“Dr. Biederman is not someone to jerk around,” Mr. Bruins wrote. “He is a very proud national figure in child psych and has a very short fuse.”

Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made for a $280,000 research grant. “I have never seen someone so angry,” Mr. Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.”

Mr. Bruins concluded that unless Dr. Biederman received a check soon, “I am truly afraid of the consequences.”

A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, where Dr. Biederman serves as chief.

A 2002 annual report for the center said its research must satisfy three criteria: improve psychiatric care for children, have high standards and “move forward the commercial goals of J.& J.,” court documents said.

“We strongly believe,” the report stated, “that the center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children.

“Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events.”

A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson executive, said Dr. Biederman approached the company “multiple times to propose the creation” of the center. “The rationale of this center,” the message stated, “is to generate and disseminate data supporting the use of risperidone in” children and adolescents.

Documents show that Johnson & Johnson gave the center $700,000 in 2002 alone. Massachusetts General said in its statement on Monday that grant agreements indicated the center “was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.”

A statement Monday from Janssen Pharmaceutica, a unit of Johnson & Johnson, said it helped finance the research center in 2002 “with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”

A June 2002 e-mail message to Dr. Biederman from Dr. Gahan Pandina, a Johnson & Johnson executive, included a brief abstract of a study of Risperdal in children with disruptive behavior disorder. The message said the study was intended to be presented at the 2002 annual meeting of the American Academy of Child and Adolescent Psychiatry.

“We have generated a review abstract,” Dr. Pandina wrote, “but I must review this longer abstract before passing this along.”

One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly. “So, if you could,” Dr. Pandina added, “please give some thought to how to handle this issue if it occurs.”

The draft abstract that Dr. Pandina put in the e-mail message, however, stated that only the children given Risperdal improved, while those given placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing himself as the author so the company could present the study to the conference, according to the message.

“I will review this morning,” responded Dr. Biederman, according to the documents. “I will be happy to sign the forms if you could kindly send them to me.” The documents do not make clear whether he approved the final summary of the brief abstract in similar form or asked to read the longer report on the study.

Drug makers have long hired professional writers to compose scientific papers and then recruited well-known doctors to list themselves as the author. The practice, known as ghostwriting, has come under intense criticism recently, and medical societies, schools and journals have condemned it.

In June, a Congressional investigation revealed that Dr. Biederman had failed to report to Harvard at least $1.4 million in outside income from Johnson & Johnson and other makers of antipsychotic medicines.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked by Senator Charles E. Grassley, an Iowa Republican who is leading the Congressional inquiry, to check again, Dr. Biederman said he had received $3,500. But Johnson & Johnson told Mr. Grassley that it paid $58,169 to Dr. Biederman in 2001.

A Harvard spokesman, David J. Cameron, said Monday that the university was still reviewing Mr. Grassley’s accusations against Dr. Biederman. Mr. Cameron added that the university had not seen the drug company documents in question and that it was not directly involved in the child psychiatry center at Massachusetts General.

Calls to Dr. Biederman were not returned.

Filed under: antipsychotics, MGH, , , , ,

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