Report on the Escalating International Warnings on Psychiatric Drugs

[Guest guest]

Report on the Escalating International Warnings on Psychiatric Drugs JoAnn

Guest Nov 04, 2005 16:51 PST

 

http://www.healthliesexposed.com/articles/article_2005_10_28_1646.shtml

 

10/28/05 Source: Citizens Commission on Human Rights

Report on the Escalating International Warnings on Psychiatric Drugs by

Citizens Commission on Human Rights

 

Introduction

 

In 1990, the Citizens Commission on Human Rights (CCHR) asked American

Psychiatrist and the Food and Drug Administration (FDA), to issue

warnings about the latest psychiatric drug causing violence and suicide:

the antidepressant Prozac. CCHR filed complaints and provided evidence.

In response, on September 20, 1991, the FDA ordered an advisory

committee to hold a hearing to investigate the safety and effectiveness

of antidepressant drugs. A panel of nine psychiatrists, many with

financial ties to pharmaceutical companies, heard chilling testimony

from medical experts as well as the victims of these drugs - and did

nothing.

 

It was not until 13 years later, on 15th October 2004, that the FDA

finally ordered pharmaceutical companies to add a " black box " warning to

antidepressants, saying the drugs could cause suicidal thoughts and

actions in children and teenagers. It took nine months for the FDA to

issue another advisory, warning doctors to watch for suicidal behavior

in adults taking antidepressants.

 

The FDA advisories vindicated CCHR's allegations and patient and family

testimony in 1991. However millions of men, women and children were

needlessly subjected to dangerous drugs for more than a decade. Now,

with controversy growing over the previously undisclosed dangers of

psychiatric drugs, international warnings are being issued at escalating

rates, citing side-effects of drug dependence, addiction, mania,

hostility, aggression, psychosis, suicide and violence.

 

Sixteen such warnings were issued in the last year alone.

 

Following is a brief summary.

 

September 20, 1991: The FDA ordered an Advisory committee to hold a

hearing to investigate the safety and effectiveness of antidepressant

drugs. The panel's chairman, Dr Daniel Casey, stated: " I do not find

from the evidence today, that there is credible evidence to support a

conclusion that antidepressant drugs cause the emergence and /or the

intensification of suicidality and/or other violent behaviors. "

 

13 Years Later:

 

October 15, 2004: The FDA ordered pharmaceutical companies to add a

" black box " warning to antidepressants, saying the drugs could cause

suicidal thoughts and actions in children and teenagers. The agency also

directed the manufacturers to print and distribute medication guides

with every antidepressant prescription and to inform patients of the

risks.

 

December 17, 2004: The FDA required that a new warning be added to the

packaging of the " ADHD " stimulant, Strattera, showing that the drug

should be discontinued in patients who develop jaundice or liver damage.

The FDA noted, " The labelling warns that severe liver damage mat

progress to liver failure resulting in death or the need for a liver

transplant in a small percentage of patients. "

 

April 11, 2005: The FDA asked manufacturers of the atypical (new)

antipsychotic drugs to add a warning to their labelling that the drugs

could increase the risk of death in elderly patients suffering dementia.

 

 

April 25, 2005: The European Medicines Agency scientific committee

issued a statement concluding that suicide-related behavior and

hostility were more frequently observed in clinical trials among

children and adolescents treated with antidepressants compared to those

treated with placebos.

 

June 28, 2005: A document on the FDA website announced the

identification of possible safety concerns with Methylphenidate drug

products. Specifically noted were psychiatric adverse events linked to

Concerta, Ritalin and other drugs used to treat children diagnosed ADHD

(Attention Deficit Hyperactivity Disorder) such as visual

hallucinations, suicidal ideation, psychotic behavior, as well as

aggression or violent behavior. The FDA announced its intention to make

labelling changes and examine other stimulant drug products approved for

treatment of ADHD.

 

June 30, 2005: The FDA issued a Public Health Advisory entitled

" Suicidality in Adults being treated with Antidepressant Medications. "

The advisory states that several recent scientific publications suggest

the possibility of increased risk of suicidal behavior in adults taking

antidepressants and while a review of all available data is being

undertaken by the FDA, it is recommended that physicians should monitor

adults who take antidepressants for suicidal tendencies.

 

July 7, 2005: The National Centre on Addiction and Substance Abuse

issued a report that 15 million Americans were getting high on

prescription drugs, painkillers and psychiatric drugs such as Xanax,

Ritalin and Adderall, abusing these drugs more than cocaine, heroin and

methamphetamines combined. Some 2.3 million teens were abusing the drugs

per the report. Further, the study found that the teen who abuse

controlled prescription drugs were 12 times likelier to use heroin, 14

times likelier to use ecstacy and 21 times likelier to use cocaine,

compared to teens who do not abuse prescription drugs.

 

July 16, 2005: The British Medical Journal published a study by Joanna

Moncrieff, senior lecturer in psychiatry at University College London,

who found that antidepressants are no more effective than a placebo and

do not reduce depression. The study found that trials of antidepressants

with negative results are less likely to be published than those with

positive results and that within published trials, negative outcomes may

not be presented. Moncrieff found " no good evidence that these drugs

work. "

 

August 2005: Columbia University came out with a study on the abuse of

prescription drugs by teens; titled " National Survey of American

Attitudes on Substance Abuse X: Teens and Parents, " which found that the

number of Americans who abuse controlled prescription drugs has nearly

doubled between 1992 and 2003, with the number of 12-17 year olds having

jumped 212%. Further, the study shows that the percentage of teens who

have known someone who has abused prescription drugs jumped 86% from

2004 to 2005.

 

August 19, 2005: The Commission of the European Communities,

representing 25 countries, issued its decision to endorse and issue the

strongest warning yet against child antidepressant use as recommended by

Europe's Committee for Medicinal Products for Human Use (CHMP). This

followed a review of clinical trials that showed he drugs cause suicidal

behaviour, including suicide attempts and suicidal ideation, aggression,

hostility and/or related behaviour.

 

August 22, 2005: A study by Norwegian researchers disclosed that Paxil

(known in Norway as Paroxetine) increases suicide risks in adults. The

study of more that 1,500 patients found that 7 patients taking Paxil

attempted suicide compared to one suicide attempt by those on placebo.

The study also says that the recommendation to not prescribe Paxil to

children and adolescents should be extended to include usage by adults.

 

September 13, 2005: The Drug Effectiveness Review Project of Oregon

State University published a major study questioning the effectiveness

of ADHD drugs. The researchers reviewed 2287 studies, virtually every

study ever done on ADHD, and released a 731 page report which found that

there is little evidence that the drugs used to treat ADHD actually work

or are safe in the long term or that they help school performance.

 

September 22, 2005: Dr Jeffrey Lieberman of Columbia University released

a federally funded study in the New England Journal of Medicine that

found that 74% of the patients in the study discontinued antipsychotic

medication before the end of their treatment due to inefficacy,

intolerable side effects or other reasons.

 

September 23, 2005: Lester Crawford resigned as the Commissioner of the

FDA. Amongst many speculations of the reason for this resignation, The

New York Times reported " Critics, including many in Congress, said the

agency had tried to stifle one of its own scientists who had evidence

that the use of antidepressants could cause children and teenagers to

become more suicidal. "

 

September 28, 2005: The British National Health Service Institute for

Health and Clinical Excellence released a study that details the best

practice advice on the care of children and young people with depression

and gives Clinical Guidelines on " Depression in Children and Young

People. " The Guideline specifies regular exercise, sleep and a balanced

diet as the first levels of therapy and further states that

antidepressants should not be used for the initial treatment of children

and young people with mild depression.

 

September 29, 2005: The FDA ordered that " black box " warnings be based

on a commonly prescribed ADHD drug, after clinical trials linked the

drug to suicidal thoughts and behavior. The FDA indicated that the new

warning stems from an ongoing review of all ADHD drugs and their

possible association with suicide.

 

September 30, 2005: In a landmark report, the United Nations Committee

on the Rights of the Child, the world's premier children's rights body,

issued a strong warning against falsely labeling youth with the

psychiatric diagnosis of " Attention Deficit Hyperactivity Disorder

(ADHD) " and administering powerful ADHD drugs. In its Concluding

Observations on reports by Australia, Finland and Denmark regarding

their compliance to the UN Convention on the Rights of the Child, the

Committee expressed concern that " [ADHD] and Attention Deficit Disorder

(ADD) are being misdiagnosed and therefore psycho-stimulant drugs are

being over-prescribed, despite growing evidence of the harmful effects

of these drugs. "

 

In Summary

 

In just twelve months, more than 16 warnings have been issued on the

previously undisclosed dangers of psychiatric drugs. This comes on the

heels of public awareness campaigns by watchdog organizations,

independent medical doctors, patients and their families repeatedly

requesting independent evaluations of clinical drug trials and

accountability for the harm and loss of lives. While drug regulatory

agencies such as the FDA may be accountable for failing to act sooner,

it should be noted that psychiatrists have been their advisors, and have

a vested interest in maintaining a multi-billion dollar psychiatric drug

industry.

 

Psychiatric drug sales have soared in recent years based solely on

psychiatry's criteria for a myriad of " mental disorders, " which are

simply a checklist of behaviors, emotions and attitudes. Promoting these

disorders as medical conditions requiring drug treatment is misleading

to the public, governments and patients.

 

There are no blood tests, X-rays, brain scans or any scientific/medical

means by which psychiatry's diagnoses can be verified. Subsequently

millions of men, women and children have been wrongly diagnosed as being

mentally ill, and prescribed dangerous and potentially lethal

psychiatric drugs.

 

Medical personnel and insurance companies should be evaluating other

approaches to treating patients using standard medical diagnostic

procedures which can accurately detect and assess unwanted physical

conditions which can result in mental stress, problems and other

emotional issues.

 

Recommendations

 

1) All treatment options should include checking for underlying medical

conditions that could cause a patient's mental or emotional duress.

2) Health insurance coverage for mental health problems should only be

provided on the provision that full, searching physical examinations are

first undertaken to determine that no underlying untreated physical

condition is causing the person's mental or emotional problems. Such

examinations would be covered under existing health insurance coverage.

3) Doctors should follow the British National Health Service's Institute

for Health and Clinical Excellence (NICE) medical advisory, which

recommends first line treatment for mental or emotional problems involve

non-harmful medical solutions, including regular sleep, exercise and

nutrition.

4) The Diagnostic and Statistical Manual of Mental Disorders (DSM),

psychiatry's billing manual for mental disorders, is the key to false

escalating mental illness statistics and psychiatric drug prescriptions

and usage worldwide. Untold harm and colossal waste of mental health

funds occur because of it. It is imperative that the DSM diagnostic

system be abandoned before real mental health reform can occur.

5) Doctors and insurance companies should report all instances of

patents who have been prescribed psychiatric drugs and experienced

adverse effects to the FDA or their national drug regulatory agency.

 

www.cchr.org

 

References

 

Transcript of Proceedings, FDA Psychopharmacology Drugs Advisory

Committee, 20 Sept. 91, p. 290.

" Suicidality in Children and Adolescents Being Treated With

Antidepressant Medications " , FDA Public Health Advisory

" New Warning for Strattera, " FDA Talk Paper, 17 Dec. 04.

" FDA Issues Public Health Advisory for Antipsychotic Drugs Used For

Treatment of Behahavioral Disorders in Elderly Patients, " FDA Talk

Paper, 11 Apr. 05.

" European Medicines Agency finalises review of antidepressants in

children and adolescents, " European Medicines Agency Press Release, 25

Apr. 05.

" Statement on Concerta and Methylphenidate, " Statement posted on the FDA

website, 28 June 05.

" Suicidality in Adults Being Treated with Antidepressant Medications, "

FDA Public health Advisory, 30 June, 05.

" Accompanying Statement by Joseph Califano, Jr., Chairman and

President, " Under the Counter: The Diversion and Abuse of Controlled

Prescription Drugs in the U.S., National Center on Addiction and

Substance Abuse at Columbia University, July 05, pp. I - iii

Joanna Moncrieff and Irving Kirsch, " Efficacy of Antidepressants in

Adults, " British Medical Journal, Vol. 331, 16 July 05, pp.155-157

" Accompanying statement by Joseph A.Californo, Jr., Chairman and

President, " National Survey of American Attitudes on Substance Abuse X:

Teens and Parents, National Center on Addiction and Substance Abuse at

Columbia University, Aug 05, pp. I-ii.

" Annexe ll, " Commission Decision of 19-vlll-2005, Commission of the

European Communities, 19 Aug. 05.

Ivar Aursnes, et al., " Suicide Attempts in Clinical Trials with

Paroxetine Randomised Against Placebo, " BMC Medicine, Vol. 3, pp.14-18.

Marion S McDonagh, PharmaD, and Kim Peterson, MS, " Drug Class Review on

Pharmacologic Treatment for ADHD: Final Report, " Oregon Health and

Science University, Swept 05, pp.13-20.

Jeffery A. Lieberman, MD et al., " Effectiveness of Antipsychotic Drugs

in Patients with Chronic Schizophrenia, " New England Journal of

Medicine, Vol.353, No 12, 22 Sept. 05, pp. 1209-1232. Lauren Neergaard,

" FDA Commissioner Lester Crawford Resigns, " Associated Press, 23

Sept.05; Robert pear and Andrew Pollack, " Leader of the F.D.A. Steps

Down After a Short, Turbulent Tenure, " New York Times, 24 Sept. 05.

" Depression in Children and Young People, " National Institute for Health

and Clinical Excellence, Sept. 05, pp.16, 18 and 28.

" Suicidal Thinking in Children and Adolescents Being treated with

Strattera (Atomoxetine), " FDA Public health Advisory, 29Sept. 05.

" Concluding Observations (Australia), UN Committee on the Rights of the

Child, 40th Session, 30 Sept. 05

" Concluding Observations (Denmark), " UN Committee on the Rights of the

Child, 40h Session, 30 Sept. 05

" Concluding Observations (Finland),) UN Committee on the Rights of the

Child, 40th Session, 30 Sept. 05.

 

 

JoAnn Guest

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