Contra Pfizer
My name is Lothar Schröder, I am German and 45 years old. I studied mathematics and actuaries at Cologne University. After graduation I have worked for several insurance companies as a fixed income portfolio manger. Now I work for a bank.
I am a widower since my wife Monika killed herself three years ago.
My wife took ZOLOFT, an SSRI-antidepressant manufactured by the pharma company Pfizer. At the time she took the drug, the package insert did not warn that ZOLOFT can make people suicidal. I blame the drug for her death, because she loved live and would never have done that. She had so many plans for the future. The medical documents show that it is very likely, that there was a causal relationship between the drug ZOLOFT and her suicide.
The risk of suicide was concealed in Germany by Pfizer until August 2005, when the European Commission forced the pharmaceutical companies like Pfizer to warn about the suicide risk for children and adolescents. Some weeks ago, Pfizer has increased the age at higher risk from 18 years to 25 years. But this is nonsense. All ages are at higher risk from these SSRI- Antidepressants!
Other SSRI antidepressants are Prozac (in Germany Fluctin) and Paxil. They all carry the same risk!
This blog is about these SSRI- antidepressants and CONTRA PFIZER.
It is named after one article by Dr. David Healy who has written a book on SSRI, it is titled “Let them eat Prozac”.
I have decided to fight Pfizer and tell my story to the public.
Kirsch Study on the Lack of Efficacy of SSRI Antidepressants
A recent study by Kirsch based on the studies submitted to the FDA could not prove that SSRI-antidepressants are effective in treating mild to moderate depression. What the pharma-companies have long claimed has now been proved to be a damn lie! Why are these drugs be given to the patients, if they have severe side effects but almost no positive effects? Why were these SSRI-drugs approved by the FDA in the US, by the BfArM in Germany and in the other countries?
The regulators have to explain that to the public!
2 Kommentare:
Dear Lothar,
Perhaps these link gives some important information:
http://www.healyprozac.com/AcademicStalking/Post%204%20-%20Contra%20Pfizer.pdf
Article from 2003, Lines of Evidence on the Risks of Suicide with Selective Serotonin ...
http://www.justiceseekers.com/html/Ex22-Healy-Lines-of-Evidence.pdf
http://www.lucire.com.au/documents/pdf/HealyWhitaker.pdf
Antidepressants and suicide: risk–benefit conundrums
http://www.ahrp.org/infomail/05/10/17a.php
http://www.springerpub.com/journalsamples/contra_Pfizer.pdf
ETHICAL HUMAN PSYCHOLOGY & PSYCHIATRY: AN INTERNATIONAL JOURNAL OF CRITICAL INQUIRY
Volume 7, Number 3, Fall/Winter 2005
CONTRA PFIZER
By David Healy
[...]
SPECIFIC RESPONSES TO PFIZER
In its July 2004 letter to the FDA, Pfizer made 12 points to which I will respond.
First, the company claims its depression program has shown no evidence of suicidality. In fact, Pfizer�s depression program has a roughly 50% failure to demonstrate efficacy in clinical trials, and many of the trials undertaken with Zoloft remain unpublished. So poor were the results from the early trials that they raised concerns that this drug might not get approved, as publicly available memoranda from Dr. P. Leber to Dr. R. Temple indicate (Leber, 1991a, 1991b).
Zoloft, however, on the back of a selected set of published-only studies, has been sold by Pfizer as an SSRI with unparalleled evidence of efficacy. Arguably, there is a comparable discrepancy between the claims made by Pfizer and the evidence base for those claims, and the claims made for the use of Paxil for minors and the evidence base for that use. The claims in the latter instance were characterized in June 2004 by the attorney general from New York, Elliot Spitzer, as close to fraudulent. Regarding the evidence for suicidality from the Zoloft studies, in over 20 cases investigators have concluded that Zoloft has caused suicidality/suicidal acts, and in more than 20 further cases, Pfizer monitors overrode the judgments of the clinical investigators who had not linked Zoloft to suicidality. These Pfizer personnel attributed causality to Zoloft in the cases of these suicidality/suicidal events. Given this, it is something of a mystery as to how Pfizer can claim there is no evidence their drug causes suicide.
When data from the studies undertaken and submitted to FDA are analyzed statistically, the point estimate for the odds ratio of suicidal acts on Zoloft compared to placebo is greater than 1.0, which is indicative of a risk, and probably greater than 2.0. Pfizer has sought to manage this problem by a variety of methods, detailed below. The question of what a point estimate greater than 1.0 means in the context of SSRIs and suicide raises issues of interpretation that epidemiologists and others interested in safety issues have to deal with. Many reputable figures in these areas, including some working in the FDA, would argue that the correct interpretation of a point estimate greater than 1.0 is that given that this hazard is a potentially lethal one, it deserves appropriate warnings and monitoring. �cut�.
Just found this. The whole article is quite long. I only copy most relevant section:
http://psychrights.org/Articles/090514RWarnerOnDepravedIndifference.htm
Depraved Indifference: Drunk Driving on the Therapeutic Highway
By Richard Warner
windwarner@aol.com
May 14, 2009...9:26 pm
[…]
In another civil action against Pfizer, the manufacturer of the SSRI Zoloft, David Healy uncovered an unpublished study of healthy female volunteers that had to be cancelled after they began complaining of agitation and apprehension [25]. Healy’s own Zoloft study of 20 healthy volunteers, half given Zoloft and half a non-SSRI antidepressant, resulted in two of them becoming dangerously agitated and suicidal on Zoloft [26].
24. Degrandpre, Richard, 2002. “The Lilly Suicides,” available online at http://www.namiscc.org/News/2002/Fall/TheLillySuicides.htm
25. Id.
26. Healy, David, “Antidepressant Induced Suicidality,” Primary Care Psychiatry, 6, 2000.
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