Documentary Exposes the Truth about the Psychotropic Drugs.

30 NOVEMBER 2009

The new federal ADHD (Attention Deficit Hyperactivity Disorder) guidelines warning doctors not to use stimulant drugs as a first option for the treatment of the condition will have little effect, the Citizens Commission on Human Rights stated. The group says that for years the risks of these drugs, including death, has been known and Australian psychiatrists ignored the warning signals. The group points, as an example, to the 2004 Therapeutic Goods Administration (TGA) warning recommending that any use of SSRI antidepressants in children and adolescents should be carefully monitored for the emergence of suicidal ideation and behaviour.

Despite the warning, there have been a staggering 36 reports of children and adolescents under the age of 19 who experienced suicidal ideation or attempted suicide, while taking antidepressants and 4 deaths in the 10 to 19 age group.

Although the ADHD guidelines say drugs should not be used as first-line treatment for ADHD in preschool-aged children, it recommends a multi-model approach that “could include medication.” It stops short of banning the use of psychostimulants in children. It also fails to emphasize that there are no physical tests – blood, urine, x-rays or scans -that can confirm the diagnosis as a physical illness requiring medical treatment.

Last month it was reported that at least 30 children wanted to kill themselves or became psychotic while on psychostimulants. CCHR’s Executive Director, Shelley Wilkins, said, “If 30 children had felt suicidal or became psychotic after eating foods with harmful chemical additives, that product would be pulled from the market and the additive most likely banned. Psychiatrists advising the federal government on these guidelines are protecting their own interests – not those of children.”

It took consumer groups, parents and a handful of concerned doctors and legislators to even raise the alarm about psychostimulants. CCHR filed a Freedom of Information request to the TGA to drag the full disclosure of the stimulant adverse reactions drugs into the open.

Psychiatrists and the pharmaceutical industry stood by silent because they are making a killing out of these drugs, CCHR said. To further drive this point home, CCHR is distributing its groundbreaking film Making a Killing: The Untold Story About Psychotropic Drugging – a multi-award winning documentary in the United States.

Australia has already experienced an annual 12% increase in prescription rates of psychostimulants since 2003, with sales of the drugs now reaching $21 million. The ADHD Draft Guidelines have disclosed those review committee members with conflicts of interest with the pharmaceutical industry – again, a response to public, not professional pressure. At least 9 of the members have/have had financial ties.

One member, Darryl Efron, headed the task force until public exposure of his being on the advisory board for Novartis and Eli Lilly – two of the biggest manufacturers of ADHD drugs. Other committee members have conducted clinical drug trials for or been paid by Lilly, Pfizer, and Janssen-Cilag – companies that have been the subject of major lawsuits in the US for their false or misleading marketing of their drugs, paying out more than $4 billion in the last two years alone.

In September the U.S. Department of Justice ordered Pfizer to pay a record-breaking $2.4 billion in criminal and civil fines for illegal promotions to induce doctors to use four of its products, including the antipsychotic Geodon (known in Australia as Zeldox). The same month, Eli Lilly agreed to pay $1.5 billion to the US government to settle criminal and civil cases surrounding the promotion of Zyprexa for the off-label promotion of its use on elderly patients. [See sample list attached.]

CCHR says there needs to be a full investigation of the pharmaceutical industry partnership with psychiatrists and Australian groups that they fund to determine what influence it has on prescription trends and cost to Medicare and private insurance as well as mental health budgets.

Adverse Reactions reported to the TGA that CCHR FOI’ed and requested, include:

• Antipsychotics: There were 9,532 adverse reaction reports to the TGA. Of those, 390 involved children younger than 18 years of age. 399 of the 9,532 had a fatal outcome.
• A 5 year old suffered depression and paranoia while taking Ritalin – psychiatric events are now recognized side effects of such stimulants.
• Another 5 year old suffered a stroke while on Ritalin – again, a side effect being reported for years yet only officially acknowledged recently.
• A 7 year old tried to commit suicide by running in front of a car and jumping off a roof while on Ritalin.
• A 12-year-old boy while on Ritalin became obsessed with dead bodies and hanging himself.
• A 13-year-old girl experienced abnormal heartbeat and blacked out while on an antipsychotic.
• A 15-year- boy put on 40kg while on an antipsychotic – drugs now recognized as causing life-threatening diabetes.
• A 4 year old on an antidepressant had such severe panic she thought her death was impending.
• A 14-year-old girl while on the antidepressant Zoloft, experienced suicidal ideation when she had no previous history of this.

Spending on psychotropic drugs on the Australian Pharmaceutical Benefits Scheme (PBS) has increased 663% since 1992-93 ($82 million to $625 million) three and a half times the rate of growth in overall PBS expenditure. ⁽¹⁾ Psychostimulants prescriptions (ADHD drugs) have been increasing by an average annual rate of change of 12% from 2003/04 to 2007/08.⁽²⁾

The enclosed film – Making a Killing: The Untold Story of Psychotropic Drugging – provides the facts. Watch Chapter 3: Disease Mongering, and Chapter 7: Side Effects, for some of these facts. Please use the information and quotes from those interviewed about this dangerous situation that will not be averted by the current ADHD Guidelines. Watch the complete documentary for the full story.

The Citizens Commission on Human Rights was co-founded in 1969 by the Church of Scientology and Dr Thomas Szsaz, professor of psychiatry to investigate and expose psychiatric violations of human rights. CCHR was instrumental in obtaining the 1988-1990 Royal Commission Inquiry into Deep Sleep Treatment at NSW’s Chelmsford Hospital.

RECENT LAWSUITS FILED AND COURT DECISIONS IN THE US AGAINST PHARMA

June 3, 2004: State of New York vs. GSK: GSK paid $2.5 million (A$2.6 million) to settle the lawsuit that alleged “persistent fraud” in suppressing research on Paxil that had shown it increased the risk of suicidal thoughts and actions in children taking the antidepressant.⁽³⁾

March 27, 2008: State of Alaska vs. Eli Lilly & Co.: The company paid $15 million (A$16 million) to settle the state’s civil suit (filed in 2006), alleging that it illegally marketed Zyprexa for conditions for which it was not approved to treat and for downplaying the known diabetic and hyperglycemic side effects of the drug.⁽⁴⁾

October 7, 2008: State of Texas vs. Eli Lilly & Co.: An 18-month long investigation of Lilly by 33 states, under the Texas Consumer Protection Act, ended in a judgment and injunction calling for Lilly to pay $62 million ($A66.6 million) and agree to numerous restrictions and reforms for the ensuing six years regarding its promotion, marketing, medical communications and other aspects of business relating to Zyprexa. ⁽⁵⁾

January 15, 2009: USA vs. Eli Lilly & Co.: Eli Lilly agreed to pay $1.4 billion (A$1.5 billion) to the U.S. government to settle criminal and civil cases surrounding the promotion of Zyprexa for the off-label promotion of its use on elderly patients with dementia. Lilly entered into an agreement with the U.S. Department Of Justice to plead guilty to a criminal charge of unlawful promotion of Zyprexa for non-Food and Drug Administration (FDA)-approved uses, specifically as a treatment for dementia in the elderly. It paid a penalty fine of $615 million (A$661 million). The company also settled a concurrent federal civil investigation, paying $800 million (A$860), to be split between the federal government and the states. ⁽⁶⁾

March 2, 2009: West Virginia vs Johnson & Johnson (Janssen is a subsidiary): Brook County Court Judge Martin Guaghan ordered J & J to pay the state $4.4 million (A$4.7 million) for false advertising regarding two of its products, one of which was its antipsychotic drug Risperdal. ⁽⁷⁾

April 29, 2009: State of Georgia vs. Eli Lilly & Co: Lilly paid $15 million (A$16 million) to the state of Georgia to settle the state Attorney General’s civil suit over the company’s unlawful promotion of Zyprexa for non-FDA-approved uses. ⁽⁸⁾

August 21, 2009: West Virginia vs. Lilly: Lilly agreed to pay $22.5 million (A$24 million) to the state of West Virginia to settle a similar AG-filed suit regarding its Zyprexa activities. ⁽⁹⁾

September 2, 2009: USA vs. Pfizer: The U.S. Department of Justice ordered Pfizer to pay a record-breaking $2.3 billion (A$2.4 billion) in criminal and civil fines for illegal promotions to induce doctors to use four of its products, including the antipsychotic Geodon. To prevent future occurrences of illegal promotion, the company was placed under the monitoring of the federal Department of Health and Human Services Office of Inspector General for five years. ⁽¹⁰⁾

September 2, 2009: Maryland vs. Pfizer: The company paid $33 million (A$35.4 million) to 43 states to settle consumer protection claims against them regarding Geodon. The suit, filed by the Attorneys General of Maryland and Delaware, was filed on behalf of all the AGs involved. It alleged that Pfizer engaged in unfair and deceptive practices when it marketed Geodon. ⁽¹¹⁾

November 3, 2009: The Acting United States Attorney Michael K. Loucks and Tony West, Assistant Attorney General for the Justice Department’s Civil Division announced the Government has reached settlements of $98 million (A$105.3 million) with Omnicare, Inc. (“Omnicare”), of Covington, Kentucky, solicited and received kickbacks from Johnson & Johnson (J&J, which owns Janssen), a pharmaceutical manufacturer, in exchange for agreeing to recommend that physicians prescribe Risperdal, a J&J antipsychotic drug, to nursing home patients. ⁽¹²⁾

1. “Department of Health and Ageing (2007) National Mental Health Report 2007: Summary of Twelve Years of Reform in Australia’s Mental Health Services under the National Mental Health Strategy 1993-2005,” Commonwealth of Australia 2008 pages 24 and 163.
2. Mental Health Services in Australia 2006-07, Australian Institute of Health and Welfare Canberra, August 2009 Page 125.
3. David B. Caruso, “GlaxoSmithKline begins releasing data on drug trials,” Associated Press, 2 Sept. 2004; The People of the State of New York, by Eliot Spitzer, Attorney General of the State of New York vs. GlaxoSmithKline.
4. Alex Berenson, “Alaska Suit Against Lilly Is Settled, New York Times, 27 Mar. 2008.
5. Final Judgment and Agreed Permanent Injunction, State of Texas vs. Eli Lilly and Company, Cause No. 08-12714, 7 Oct., 2008 and “Texas, 33 States Reach Landmark $62 Million Settlement with Eli Lilly & Company,” press release of Texas Attorney General, 7 Oct. 2008.
6. “Eli Lilly to pay $1.4 billion to settle Zyprexa suits,” CNNMoney, 15 Jan. 2009.
7. “Court orders Johnson & Johnson to pay millions for misleading WV doctors; Attorney General McGraw states false advertising,” West Virginia General Press Release, 2 Mar. 2009.
8. “Georgia settles with drug company for $6M,” Atlanta Journal Constitution, 29 Apr. 2009.
9. “State settles lawsuit against Eli Lilly,” Charleston Gazette, 21 Aug. 2009.
10. “Pfizer to pay record $2.3B penalty over promotions,” Miami Herald, 2 Sept. 2009.
11. “Attorney General Gansler leads settlement of consumer protection claims against Pfizer, Company to pay $33 million as part of settlement,” press release of the Maryland Attorney General, 2 Sept. 2009.
12. http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Nov2009/OmnicarePR.html