Citizens Commission on Human Rights of St. Louis

http://www.transworldnews.com/NewsStory.aspx?id=69298&cat=10

Stockholm, Sweden 12-01-2008 09:38 GMT (TransWorldNews)

BigPharma’s latest psychostimulant drug is Strattera. Its manufacturer, Eli Lilly, has now changed the label for the drug in Europe to include warnings that Strattera CAUSES “hallucinations, delusional thinking, mania or agitation in children and adolescents without a prior history of psychotic illness or mania … at usual doses”.

 

Please note that Strattera is CAUSING these symptoms – that these “symptoms” seen in children are drug induced, that they in actual fact are signs of drug induced brain dysfunction.

 

It took almost THREE years of foot dragging before the medical authorities in Europe finally decided that Eli Lilly should issue warnings about psychotic reactions in the label for Strattera. But now the warnings are finally out.

 

The story leading up to these warnings can be read in the following article (see also links in the article to background data): The ADHD drug Strattera – actions needed now, from January 2008, http://jannel.se/letter.mhra.strattera.jan08.pdf (See also article about Strattera death at http://jannel.se/Strattera.death2.pdf)

 

The new warnings about the causal role for Strattera in inducing mania, agitation and psychosis with hallucinations, can be read at http://emc.medicines.org.uk/emc/assets/c/html/displaydoc.asp?documentid=14482

 

In the US famous psychiatrists like Dr. Joseph Biederman have convinced doctors that the manic states seen in children receiving ADHD drugs (like Concerta, Adderall and Strattera) are signs of “bipolar disorder” – not signs of drug induced brain dysfunction.

 

This has meant that children in the US, instead of being taken off the dangerous drugs are given the most toxic substances available in psychiatry – neuroleptics (so called antipsychotics like Risperdal, Zyprexa and Abilify).

 

These new warnings in Europe for Strattera, together with all exposures of the fraudulent affairs of Biederman and colleagues, should finally convince doctors about the facts and what needs to be done – that the harmed children need to be taken off the drugs under careful supervision.

 

Janne Larsson

Reporter – investigating psychiatry

Sweden

janne.olov.larsson@telia.com

http://news.bbc.co.uk/2/hi/health/7764512.stm

The practice of forcing psychiatric patients to take medication is not backed by evidence, say UK researchers

Very few rigorous investigations of the use of coerced medication have been done despite it being widespread, the Journal of Advanced Nursing reported.

The dearth of evidence is “unacceptable” and more should be done to find alternatives, the team said.

A spokeswoman for Mind said the threat of forced medication often stopped people seeking help in the first place.

Expert or Shill?
More evidence has emerged of appalling conflicts of interest that throw into doubt the advice rendered and the research performed by two prominent psychiatrists who have received substantial funding from the pharmaceutical industry. The revelations prove, once again, the need for universities and professional societies to crack down on conflicts of interest, and for Congress to pass legislation that will bring hidden conflicts into the open.

Earlier this year, Congressional investigators discovered that Dr. Joseph Biederman, a world-renowned child psychiatrist at Harvard Medical School and Massachusetts General Hospital, had failed to report to Harvard at least $1.4 million in income from drug companies, in violation of the university’s conflict-of-interest guidelines.

Now, internal drug company e-mail and documents that surfaced in a lawsuit have sketched out what looks like an unsavory collaboration between Dr. Biederman and Johnson & Johnson to generate and disseminate data that would support use of an antipsychotic drug, Risperdal, in children, a controversial target group.

The various documents indicate that Dr. Biederman repeatedly asked a Johnson & Johnson subsidiary to fund a research center at Massachusetts General to focus on children and adolescents with bipolar disorders and that the company provided almost $1 million. Disturbingly, one of the center’s publicly stated missions, along with improving the psychiatric care of children, was to “move forward the commercial goals of J.& J.”

The company also drafted a scientific abstract on Risperdal for Dr. Biederman to sign — as if he were the author — before it was presented at a professional meeting. And it sought his advice on how to handle the uncomfortable fact, not mentioned in the abstract, that children given placebos, not just those given Risperdal, also improved significantly.

Dr. Biederman’s work and reputation have helped fuel a huge increase in the use of powerful, risky and expensive antipsychotic medicines in young people, an upsurge that brought a warning recently from a federally appointed panel of experts. Now it is hard to know whether he has been speaking as an independent expert or a paid shill for the drug industry.

Congressional investigators also recently reported that Frederick Goodwin, an influential psychiatrist who has been hosting a popular weekly program on public radio, earned at least $1.3 million by giving marketing lectures for drug makers who potentially stood to benefit from the recommendations he made on the program. He has rightly been removed from the air.

Psychiatry is facing unprecedented exposure for drugging children with unapproved psychotropic drugs, and for ties to drug companies.  In less than a week we’ve seen coverage in the Wall Street Journal, New York Times, USA Today, Boston Globe and LA Times, among others.

From the top down, exposure of psychiatry over the last six months goes like this:

• Former head of National Institutes of Health and leading mental health talk show host, Fred K. Goodwin, was exposed for not reporting pharmaceutical money to listeners or producers.  He promoted such things as the diagnosis of bipolar disorder in children, which undoubtedly contributed to the continued rise in dangerous and unproven antipsychotic drugs for this use.

• The infamous Dr. Joe Biederman, Harvard researcher and noted promoter of the Bipolar diagnosis in children was exposed for taking far more money from drug companies than he reported to the University. Yesterday the New York Times reported that internal documents and e-mails between a drug company and Biederman showed him pressuring the drug company to open a research center to “promote the commercial goals of [drug company name deleted].” While Biederman continues to be under investigation, he is credited for helping to fuel the 40 fold increase in the bipolar diagnosis for kids, which of course was accompanied by exploding prescriptions for dangerous, off-label drugs.

• Then there was the exposure of Karen D. Wagner at the University of Texas Medical Branch in Galveston, who according to US Senator Charles Grassley, failed to disclose tens of thousands of dollars in drug company money while writing guidelines for the drugging of children.  Wagner wrote a chapter of psychiatry’s textbook on psychopharmacology dealing with the treatment of children during this time as well. 

Of course, the editors of the textbook would have gone out of their way to guard against conflicts of interest, right?  That’s what you would think…

Psychopharmacology textbook editors Charles Nemeroff and Alan Schatzburg were both exposed for failing to reveal substantial funding from drug companies.

This isn’t a complete list by any means, but I think you get the picture.  Psychiatry, from top to bottom, is riddled with conflict of interest allegations, and drug companies denying the off-label promotion of their drugs while industry “thought leaders” continue to be found with their hands in the pharmaceutical “cookie jar.”

There is legislation both federally and in the state of Texas to require drug companies to disclose their payments to doctors so that these marketing schemes can be known about up front. Write your own state legislators to introduce and pass legislation to audit psychiatric outcomes, prosecute psychiatric fraud and abuse, and eliminate psychiatrists and psychiatric funding from our schools and communities.

By Rita Rubin, USA TODAY
11/24/2008

Among all the drugs prescribed to treat conditions for which they’re not approved, doctors and patients should be most concerned about antipsychotics and antidepressants, a study suggests today.

This “off-label” prescribing is a legal, common practice that is being questioned in some cases because of inadequate scientific evidence to support its safety and effectiveness.

“Although previous research has highlighted the substantial frequency of off-label drug use without good evidence, we have identified and prioritized specific drugs warranting attention,” the authors of the new study write in the journal Pharmacotherapy.

They list 14 drugs for which needed research into off-label use is most pressing. Three are antipsychotics, six are antidepressants. The researchers considered three factors in devising their list: the volume of off-label use with inadequate evidence, drug safety, and cost and market considerations.

Seroquel, an antipsychotic approved for treating schizophrenia and short-term manic or depressive episodes in bipolar disorder, topped the list. Three out of four times, doctors use the drug off-label, mainly for maintenance therapy for bipolar disease, says senior author Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center.

“It’s not that these off-label uses are necessarily harmful or that these drugs don’t work,” Stafford says. The problem, he says, is that no one can be certain, because needed studies haven’t been done.

The FDA requires drug companies to test their drugs only against conditions for which they’re seeking approval. “Clearly, for many of these off-label uses, the manufacturers are benefiting enormously, and in some cases I think one could argue that off-label use has allowed them to circumvent the regulatory process,” Stafford says. Although the regulatory process is not infallible, he says, “it does provide a level of scrutiny” beyond what the off-label uses have received.

Diedtra Henderson, a spokeswoman for the Pharmaceutical Research and Manufacturers Association, a trade group, said her organization could not comment on off-label prescribing. “That’s nothing being driven by our companies,” she said. “This is an activity that our companies aren’t allowed to do under FDA regulations.”

But according to a paper posted last month by the online journal PLoS Medicine, industry-paid “nationally known, influential academic physicians” help create “buzz” about off-label uses by writing about them for publication or presentation at scientific meetings. The article was written by physician Adriane Fugh-Berman of Georgetown University Medical Center in Washington, D.C., and Douglas Melnick, a preventive medicine doctor in North Hollywood, Calif.

Earlier this month in PLoS Medicine, medical school professor Michael Wilkes and law professor Margaret Johns, both of the University of California, Davis, called for doctors always to inform patients that they want to use a drug off-label, giving them the chance to decide whether they want to take it.

### ### ###

Of course, on-label or off-label use of psychotropic drugs is equally harmful, as you will find once you watch this documentary video:

http://www.cchr.org/#/videos/making-a-killing-introduction

Recognize that the real problem is that psychiatrists fraudulently diagnose life’s problems as an “illness”, and stigmatize unwanted behavior or study problems as  “diseases.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax – unscientific, fraudulent and harmful. All psychiatric treatments, not just psychiatric drugs, are dangerous, and can cause crime.

http://www.bloomberg.com/apps/news?pid=20601087&sid=atN6Se0NVbp0&refer=home

By Rob Waters and Julie Ziegler

Nov. 25 (Bloomberg) — Massachusetts General Hospital will investigate conflicts of interest at a child psychiatry research center it established with funding from Johnson & Johnson, maker of the antipsychotic drug Risperdal.

The hospital, in a statement yesterday, said its grant specified the purpose of the center was scientific and educational, not to promote J&J’s products. Yet the center’s 2002 annual report said it would undertake studies that “will move forward the commercial goals of J&J,” according to documents released in connection with a lawsuit against the company.

The Johnson & Johnson Center for the Study of Pediatric Psychopathology was run by Joseph Biederman, a Harvard University child psychiatrist whose research helped fuel an explosion in the number of children diagnosed with bipolar disorder and treated with antipsychotics. His ties to J&J and other drugmakers were criticized in June by Senator Charles Grassley, an Iowa Republican, who said Biederman failed to disclose most of the $1.6 million he received from the industry from 2000 to 2007.

“I would question how this conduct — the acceptance of money — advances public health,” said Steven Sheller, a Philadelphia attorney who represents the families of children suing J&J in connection with side effects from Risperdal. The hospital is “supposedly interested in public health.”

David Cameron, a spokesman for Boston-based Harvard Medical School, said Harvard isn’t involved with the J&J Center at Massachusetts General, a Harvard teaching hospital.

‘Individually Governed’

“Harvard Medical School does not ‘own’ any of its teaching hospitals,” Cameron said in an e-mail. “While we are affiliated with them through academic appointments, all teaching hospitals are individually governed.”

Biederman didn’t reply to phone messages and e-mails sent to his office.

Massachusetts General, which pledged in June to investigate drug industry payments to Biederman, “takes these allegations very seriously and intends to investigate these issues thoroughly,” said Peggy Slasman, a hospital spokeswoman, in an e-mail yesterday.

The documents were released at a time of fierce debate over the increasing use by children of powerful antipsychotic drugs that can cause weight gain, diabetes and hormonal and neurological effects. Biederman is a leading proponent of the idea that bipolar disorder, once viewed as an adult disease, can begin early in childhood and be treated with drugs. People with bipolar disorder alternate between bouts of depression and mania.

The number of children diagnosed as bipolar increased 40- fold between 1994 and 2003, according to a 2007 study. Sales of drugs used to treat the condition doubled from 2003 to 2006, according to data provided to Bloomberg in 2007 by Wolters Kluwer NV, a prescription-tracking company.

Deposition Battle

Attorneys in a New Jersey state court action against J&J have been battling to depose Biederman to explore the way the company promoted the use of Risperdal. The documents about the doctor and his child psychiatry center at Massachusetts General were released as part of the legal case.

Some plaintiffs allege that J&J promoted Risperdal to patients, including children, for whom it was not approved by U.S. regulators, a practice known as “off-label” prescribing. While doctors are free to prescribe any approved drug to any patient, companies are not allowed to promote drugs for unapproved uses. Drugmakers such as Eli Lilly & Co., the maker of Zyprexa, AstraZeneca Plc, the maker of Seroquel, and J&J are being sued by states and individuals alleging off-label marketing of their antipsychotic treatments.
J&J’s Response

Kara Russell, a spokeswoman for Janssen, the J&J unit that makes Risperdal, said the company promotes the drug and other products only for their approved uses. The company supported the Massachusetts General program “to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children,” she said in an e-mail yesterday.

The e-mails and internal memos released in the New Jersey lawsuit show Biederman pressed the company for money to establish the center and J&J used the data from center studies to promote Risperdal in children. J&J funded the center from 2002 to 2006.

Biederman “approached Janssen multiple times to propose the creation of a Janssen-MGH center,” according to an e-mail from a J&J executive. The center would “generate and disseminate data supporting the use” of Risperdal in children, the e-mail said. Pediatric use was approved by U.S. regulators in August 2007.

The e-mails released in the lawsuit also show that J&J was closely involved in Risperdal studies undertaken by Biederman and his colleagues at the center.

Generating the Data

In one e-mail, Gahan Pandina, a J&J clinical development executive, sent Biederman a research summary to be presented at a medical conference. The summary listed Biederman as the lead author and concluded that Risperdal “is effective” in treating children with bipolar disorder. In the e-mail, Pandina said he “was able to have our statistics department generate the summary data” and asked Biederman to review, comment and sign a form “as the presenting author.”

The influence Biederman has on other doctors was hinted at in a 2002 e-mail from Pandina, which noted the psychiatrist was “very well received” by a group of 1,000 doctors who paid $700 each for a three-day course on medications for pediatric bipolar disorder. Forming a partnership with Biederman and his program “has the potential of reaching and having a significant impact” on child psychiatrists.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

November 18th, 2008