Three members of MindFreedom Ireland, Nuria O Mahony, John Mc Carthy

  and Mary Maddock, received coverage in the Irish media yesterday.

   The subject was the latest U.K. research which found that

    antidepressants known as SSRIs are very rarely found to help depression.

 

 

 

 Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the FDA

 

 

 

 

 

"Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration" by Irving Kirsch, Brett J. Deacon, Tania B. Huedo-Medina, Alan Scoboria, Thomas J. Moore, Blair T. Johnson, has just been published in PLoS (Public Library of Science) The study addresses the clinical question: is the risk / benefit ratio of antidepressants favorable for patient use?The conclusion: "compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression." [Link]This new study by expands the authors' previous analysis, The Emperor's New Drugs (2006) [1] as well an earlier analysis by the principle author (2005). [2]The just released study utilizes additional--decades old data--released to the authors by the FDA.The authors note: "Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance. Yet, the efficacy of the antidepressants may also depend on the severity of initial depression scores. The purpose of this analysis is to establish the relation of baseline severity and antidepressant efficacy using a relevant dataset of published and unpublished clinical trials.""Conventional meta-analyses are often limited to published data. In the case of antidepressant medication, this limitation has been found to result in considerable reporting bias characterized by multiple publication, selective publication, and selective reporting in studies sponsored by pharmaceutical companies. To avoid publication bias, we evaluated a dataset that includes the complete data from all trials of the medications, whether or not they were published. Specifically, we analyzed the data submitted to the FDA for the licensing of four new-generation antidepressants for which full data, published and unpublished, were available. As part of the licensing process, the FDA requires drug companies to report "all controlled studies related to each proposed indication" (emphasis in original). Thus, there should be no reporting bias in the dataset we analyze."We challenge the FDA on two points:

If independent analyses of data submitted to the FDA conclude that the drugs failed to demonstrate clinical improvement and the drugs' safety profile shows serious risks of harm--including increased suicides and suicide attempts--one has to question the FDA approval process. What was the safety and efficacy standard used by the FDA to justify approval of the new generation antidepressant and antipsychotic drugs ? The question undercuts current legal arguments deferring all drug safety issues to the FDA: the preemption arguments presuppose a scrupulous, rigorous scientific FDA standard for approval and drug labeling. That presumption is not credible in light of the evidence demonstrating FDA's failure to analyze SSRI safety and efficacy data for more than 15 years.Despite wide acknowledgement that published clinical drug trial reports are biased and unrepresentative of the data, what justification is there for FDA's recent Proposed Guidance for Industry that would legalize the illegal marketing /promotion of drugs for off-label uses? See, DRAFT GUIDANCE [Link]Underscoring the significance of the PLos study findings, the government sponsored STAR*D naturalistic uncontrolled observational study confirmed the lack of antidepressant efficacy. See: Separating the Facts from the Propaganda_Latest Findings of Depression Study [Link]The conundrum for industry and psychiatry is lack scientific evidence to support the safety and effectiveness of these drugs: First, the exceedingly high placebo effect (80%) demonstrated in controlled clinical trial data submitted to the FDA [1] [2]; and second, severe adverse effects-including a twofold increased risk of suicidal behavior-now acknowledged on the drugs' label. These negative facts have led psychiatrists whose career is invested in the drugs to turn to epidemiological data [5] [6]. References:Irving Kirsch, Thomas J. Moore, Alan Scoboria, and Sarah S. Nicholls The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration, Prevention & Treatment Volume Five July 15, 2002. Target article with 9 commentaries.Joanna Moncrieff and Irving Kirsch Efficacy of Antidepressants in Adults, BMJ, 2005;331:155-157.

    SSRI Stories

Antidepressant Nightmares

WARNING: WITHDRAWAL CAN OFTEN BE MORE DANGEROUS THAN CONTINUING ON A MEDICATION.  IT IS IMPORTANT TO WITHDRAW EXTREMELY SLOWLY FROM THESE DRUGS, USUALLY OVER A PERIOD OF A YEAR OR MORE, UNDER THE SUPERVISION OF A QUALIFIED SPECIALIST.

This website is a collection of 2100+ news stories with the full media article available, mainly criminal in nature, that have appeared in the media (newspapers, TV, scientific journals)  or that were part of FDA testimony in either 1991, 2004 or 2006, in which antidepressants are mentioned. 

Antidepressants have been recognized as potential inducers of mania and psychosis since their introduction in the 1950s.  Klein and Fink1 described psychosis as an adverse effect of the older tricyclic antidepressant imipramine. Since the introduction of Prozac in December, 1987, there has been a massive increase in the number of people taking antidepressants. Preda and Bowers2 reported that over 200,000 people a year enter a hospital with antidepressant-associated mania and/or psychosis. The subsequent harm from this prescribing can be seen in these 2100+ stories.

 These stories have been collected over a period of years by two directors of the International Coalition for Drug Awareness (ICFDA).  Their focus has been on Selective Serotonin Reuptake Inhibitors (SSRIs), of which Prozac was the first.  Other SSRIs are Zoloft, Paxil  (Seroxat), Celexa, Sarafem (Prozac in a pink pill), Lexapro, and Luvox.  Other newer antidepressants included in this list are Remeron, Anafranil and the SNRIs Effexor, Serzone and Cymbalta as well as the dopamine reuptake inhibitor antidepressant Wellbutrin (also marketed as Zyban). A public health problem of epidemic proportions The Physicians' Desk Reference lists the following adverse reactions (side effects) to antidepressants among a host of other physical and neuropsychiatric effects: manic reaction (mania, e.g. kleptomania, pyromania, dipsomania), emotional lability (or instability), abnormal thinking, alcohol abuse, hallucinations, hostility, lack of emotion, paranoid reaction, amnesia, confusion, agitation, delirum, delusions, hysteria, psychosis, sleep disorders, abnormal dreams, and discontinuation (withdrawal) syndrome.  Adverse reactions are especially likely when starting or discontinuing the drug, increasing or lowering the dose or when switching from one SSRI to another SSRI.  Adverse reactions are often diagnosed as bipolar disorder when the symptoms could be entirely iatrogenic (treatment induced).  Withdrawal, especially abrupt withdrawal, from any of these medications can also cause severe neuropsychiatric and physical symptoms. It is important to withdraw extremely slowly from these drugs, usually over a period of a year or more, under the supervision of a qualified and experienced specialist. In addition to the adverse reactions listed in the Physicians' Desk Reference, the FDA published a Public Health Advisory on March 22, 2004 which states (in part): "Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric."  (Click Links button at bottom of this page for a direct link to this FDA Warning.) Most of the stories on this site describe events which occurred after the year 2000.  The increase in online news material and the efficiency of search engines has greatly increased the ability to track stories.  Even these 2100+ documented stories only represent the tip of an iceberg since most stories do not make it into the media. There are 45 cases of bizarre behavior, 28 school shootings/incidents, 49 road rage tragedies, 10 air rage incidents, 32 postpartum depression cases, over 500 murders (homicides), over 180 murder-suicides and other acts of violence including workplace violence on this site.

There is a grave concern among advocates that adverse reactions are greatly underestimated by the public, the medical profession and the regulatory authorities. Each of these stories in our list can be interpreted as an adverse reaction and in most cases we have highlighted the portion of the article that refers to evidence of bizarre behavioral change consistent with drug reaction. In some stories causation is acknowledged and the juxtaposition of these stories with those where it goes unrecognized as well as the repetition of themes and circumstances is chilling. If indeed medications played a significant role in all these tragedies, then this is a public health problem of epidemic proportions on a global scale.  

How to use this web site To enter the site, click on the button below. This will bring up the site index. The index contains 5 columns, each with its own column header displayed in red. Clicking on the column header will re-sort the index according to that heading. A link to the complete media article or testimony, often with a summary heading, is available by clicking on the "What" column entry displayed in blue.

There are 2 flags set in the index which have special meaning as follows:

If the first character of the "Additional" column is a special character sequence (*,**,+,++), then the moderators of SSRIStories consider that story to be of special interest. If the last character of the "Drug" column is an asterisk, it indicates some expert has indicated the drug contributed to the events documented in the story.

1  Klein DF, Fink M.  Psychiatric Reaction Patterns to Imipramine.  Am Journal Psychiatry 1962; 119: 432-438   2 Preda and Bowers. Antidepressant-Associated Mania and Psychosis Resulting in Psychiatric Admissions . Journal of Clinical Psychiatry 2001: 62: 30-33  

You may use Google to search SSRI Stories web site. Use the 'Back' button on your browser to get back here.

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DISCLAIMER:  This site is in no way associated with either the Church of Scientology or the Citizens Commission on Human Rights (CCHR).

FAIR USE NOTICE: This may contain copyrighted © material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

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Bruce E. Levine, Ph.D., is a clinical psychologist and author of  Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Chelsea Green, 2007). Levine is also the author of Commonsense Rebellion: Taking Back Your Life from Drugs, Shrinks, Corporations and a World Gone Crazy (New York-London: Continuum, 2003), a protest book. The 26 alphabetically ordered chapters of Commonsense Rebellion detail Levine's contention that the high national rates  Bruce Levine of mental illness in the United States are really just natural reactions (e.g., discontent and disconnectedness) to the oppression of what he terms an "institutional society," which he argues causes many to break down psychologically. An earlier edition was released in 2001 with the subtitle Debunking Psychiatry, Confronting Society — An A to Z Guide to Rehumanizing Our Lives. Vince

http://www.alternet.org/story/77800/

Are Antidepressants Faith-Based Treatment?

By Bruce E. Levine February 28, 2008,

While millions of people swear by Prozac, Zoloft, and other antidepressants, do they work any better than a placebo or no treatment at all?

Answering that question would be much easier if: (1) the U.S. Food and Drug Administration (FDA) revealed all drug study findings without requiring a Freedom of Information Act request, (2) drug studies with negative results were routinely published in medical journals, (3) the FDA did not rely on drug company studies employing biased research designs, (4) FDA advisory panels did not include advisers financially connected to drug companies and (5) the National Institute of Mental Health (NIMH) did not fund drug studies by researchers who have financial relationships with drug companies.

The good news? There are antidepressant researchers without ties to drug companies, and there is wisdom about overcoming depression that remains available.

On Jan. 17, 2008, the New England Journal of Medicine analyzed both published and unpublished antidepressant studies registered with the FDA between 1987-2004. Examining 12 antidepressants, Dr. Erick H. Turner, a former FDA medical reviewer, and his research team included data gained via the Freedom of Information Act.

Dr. Turner discovered that most studies with negative results were never published in journals, and so doctors had no way of knowing how poorly antidepressants have actually fared. While 94 percent of antidepressant studies published in journals show antidepressants to be more effective than placebos, only 51 percent of all registered studies were determined by the FDA to show antidepressants superior to placebos.

Why are most negative results not published in journals? Drug studies are routinely funded by the drug's manufacturer, which has no interest in the publication of negative results. Also, medical journals are increasingly dependent on advertising revenue from drug companies, which results in a disincentive to publish negative results.

Antidepressant advocates point out that when comparing all research subjects, antidepressants retain an advantage -- albeit a modest one -- over placebos. However, that belief is based on studies funded by drug companies, utilizing research designs biased in favor of antidepressants.

One such research-design bias is the use of depression measurements that weigh heavily depression symptoms most likely to improve with antidepressants (such as sleep problems and agitation), and weigh less heavily depression symptoms not as likely to improve with antidepressants (such as suicidal thoughts and joylessness).

Why does the FDA allow measurement bias and other dice loading that favors antidepressants? Marcia Angell, former editor in chief of the New England Journal of Medicine, concludes that the FDA has been compromised by drug companies. Dr. Angell reports that, for example, in the majority of FDA drug-approval advisory meetings through 2000, half or more of the FDA advisers had conflicts of interest -- financial relationships with drug companies.

A critical scientific standard in drug studies is the double-blind control (neither subject nor experimenter knows who is getting the drug and who is getting the placebo), but drug-company antidepressant studies use blinds that can be peeked through. How? Inactive placebos such as sugar pills, which don't create side effects, are used, and so subjects can more easily guess if they are getting the actual drug. In order to make it more difficult to penetrate the blind, an active placebo, which creates side effects, should be used. In 2000, a Psychiatric Times article concluded: "In fact, when antidepressants are compared with active placebos, there appear to be no differences in clinical effectiveness."

In addition to biased depression measurements and an absence of a true double blind control, the FDA also accepts antidepressant research in which subjects who respond favorably to placebos are weeded out from final trials.

Thus, it is especially embarrassing for antidepressant manufacturers that despite research-design biases in favor of antidepressants, these drugs achieve superiority to placebos in only 51 percent of the studies.

In a widely covered announcement in March 2006, NIMH reported that 50 percent of depressed people experience remission of symptoms in a two-step treatment study (which ultimately would include four steps) called Sequential Treatment Alternatives to Relieve Depression (STAR*D). Unannounced by NIMH and STAR*D researchers -- who had financial relationships with antidepressant manufacturers -- was that for each of these antidepressant treatment steps, remission rates were lower than or equal to the customary placebo performance in other antidepressant studies (there was no placebo control in this $35 million U.S. taxpayer-funded STAR*D study).

Moreover, NIMH and STAR*D researchers neglected to mention that in the same time it took to complete steps one and two of STAR*D (slightly over six months), previous research shows that depressed people receiving no treatment at all have a spontaneous remission rate of 50 percent -- this identical to STAR*D results over that same time span. Worse yet, by the time all four STAR*D's treatment steps had been completed, relapse rates were so high that the November 2006 American Journal of Psychiatry calculated the actual cumulative remission rate to be, at best, 43 percent.

The most benign thing that one can say about drug companies' efforts in creating faith in antidepressants is that faith is a significant reason these antidepressants are effective at all. In 2004, the Journal of Clinical Psychiatry reported that among those depressed patients expecting an experimental antidepressant to be "very effective," 90 percent had a positive response (not necessarily remission); while among those expecting the medication to be "somewhat effective," only 33 percent had a positive response. Depressed people with "no faith" in antidepressants were not included in this study, but such nonbelievers rarely tell me about having a positive response with antidepressants. As one might expect, drug companies do nothing to ensure that depressed people who have little or no faith in antidepressants are proportionately included in studies.

More than a century ago, psychologist and philosopher William James understood the importance of belief, faith and expectations, or what scientists now call the "placebo effect." "Faith in a fact can help create the fact," James famously observed in his essay, "The Will to Believe." James was a tough-minded scientist, but when it came to discovering an antidote to his own, often debilitating, states of depression, he came to "believe in belief." James, however, knew that while any given belief may "work," it also may have undesirable side effects. So he pragmatically considered many beliefs before choosing to believe that "life shall [be built in] doing and suffering and creating."

Different faiths fit different temperaments. I know people who have overcome depression with antidepressants, psychotherapy, prayer, philosophy, political activism, dietary supplements, art, exercise and other approaches. Science has no clear favorites and invites pluralism. However, we should not be cavalier in what we choose to believe, because our beliefs determine in no small way what kind of people we are and what kind of effect we have on society.

© 2008 Independent Media Institute. All rights reserved.

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THIS IS A VERY INTERESTING LINK ADDED TO  WWW. MINDFREEDOMIRELAND.COM/ LINKS TODAY.  IT WOULD BE GOOD TO GET SOME FEEDBACK ON THIS AND OTHER NEWS ITEMS.

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