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Mental Health (Expert Forum)
antidepressants
Answered by
Roger Gould, M.D. - Mental Health, Wellness
Questions posted in the Mental Health forum are being answered by Dr. Roger L. Gould, author of the Mastering Stress and Depression program and affiliated with the UCLA. Department of Psychiatry. Topics covered include anger, attention deficit disorder (ADD), bipolar disorder, dementia, electroconvulsive therapy (ECT), learning disabilities, memory, obsessive compulsive disorder (OCD), panic, personality disorders, phobias, post-traumatic stress disorder (PTSD), schizophrenia, stress, transitions, and work problems.
antidepressants
by pariji, Sep 24, 2005 12:00AM
From age 22-28 I took alot of mdma; probably a total of 500 pills. I am now 34 and for the last 3-4 years have experienced definate memory problems. Also repeated episodes of shingles, IBS ..blah..blah..blah.
Recently, have dealt with 3 deaths and a new job resulting in constant anxiety with issues that have yet to play out.
I've had 3 panic attacks as diagnosed by medics and doctors. Was perscribed Zoloft for the time being. My concern is possible (previous) damage to my seratonin system while neurotransmitter system remaining intact: Is zoloft the best choice med?
I've tried to understand searches on www and found mentions of horepinephrine reuptake inhibitors (such as reboxitine)being appropriate, and something about D-fenluramine as poossible partial reverse of neurotoxins. ?
Any insight on what mild antianxiety med would be appropriate?
I really don't like the idea of something messing with my serotonin system. I think I did enough of that allready. I'm pretty positive and pleasant overall, just having a hard time at the present.
Recently, have dealt with 3 deaths and a new job resulting in constant anxiety with issues that have yet to play out.
I've had 3 panic attacks as diagnosed by medics and doctors. Was perscribed Zoloft for the time being. My concern is possible (previous) damage to my seratonin system while neurotransmitter system remaining intact: Is zoloft the best choice med?
I've tried to understand searches on www and found mentions of horepinephrine reuptake inhibitors (such as reboxitine)being appropriate, and something about D-fenluramine as poossible partial reverse of neurotoxins. ?
Any insight on what mild antianxiety med would be appropriate?
I really don't like the idea of something messing with my serotonin system. I think I did enough of that allready. I'm pretty positive and pleasant overall, just having a hard time at the present.
For what little, if any, benefit it provided the payoff was hardly worth it.
The FDA allowed Eli Lilly to use “placebo washout” to test for the efficacy of prozac.After an initial 1-2 weeks ,people responding positively to a placebo were withdrawn from the trail.This purposely creates an unnatural pool of patients and makes the drug perform better statistically.It is unscientific.
A requirement for FDA drug approval is that the drug company produces 2 or more research protocols each according to a strict and specific set of rules.Despite this,in the case of prozac,1 protocol included 10 different studies, under different leadership and at different sites.Numbers of individual studies varied from 1-10 for prozac protocols.However Eli Lilly still entered all of this into 1 pool of data for statistical purposes as if it were 1 trail based on clinical conditions although patients were given the drug under a variety of different conditions.Again this is unscientific.
The candidates for trail were cherry –picked , to give a positive impression of prozacs efficacy,instead of being chosen as required in accordance with the American Psychiatric Associations “diagnostic and statistical manual of mental disorders”.A strict criteria is laid down for trailing of drugs on depressed people. Atleast 5 out of a list of 9 factors have to apply to each patient but this requirement was not met.
People are under the false impression that prozac was trailed on serverely depressed people however prozac studies were deliberately designed to exclude such people and in particular people with tendencies or thoughts towards suicide.No study of any hospitalised psychiatric patient was put forward in those used to approve the drug.
In the 1991 publication “everything you need to know about prozac” a deliberately misleading quote is
“some of the reassurance comes from the data on over 11,000 patients who took the drug in clinical trails”
This figure was taken from a letter in august 1990 written by Eli Lilly to physicians to counteract concerns that prozac caused suicidal tendencies.The letter states –
“more than 11,000 individuals participated in clinical trails for prozac,including over 6000 treated with prozac”
However the drug label as reprinted in the Physicians Desk Reference (PDR) states that there were only “5,600 prozac-exposed” individuals in the premarketing period of evaluation.
Elsewhere in the Physicians Desk Reference its stated that only 4000 people received prozac in “US premarketting clinical trails”The only studies which are considered scientifically valid for the purposes of testing the efficacy of a drug are placebo –controlled studies but this is not how these 4000 patients were trailed.
A table of adverse reactions in the Physicians Desk Reference reviews a yet lesser 1,730 patients who were involved in “ placebo- controlled clinical trails”
Despite all the protocols being manipulated in favour of making prozac appear to work successfully only 3 were considered favourable and able to be submitted to allow the drug to be approved.
The FDA `s “summary of basis approval”,October 1988, states that out of 14 protocols involving controlled trails of prozac that were submitted for approval –
4 compared prozac to placebo and out of the other 10, 8 protocols showed prozac had no positive effect at all.Overall there were more reported negative effects from prozac and this was by Eli Lillys own selected research teams and under biased trail conditions so just what would have a proper scientific clinical trail have concluded?
It doesn’t matter how many instances a drug is proven to fail in its clinical trails.As long as eventually with as much alterating ,exclusion and misrepresentation as required ,2 or more trails show the drug to do statistically better than placebo, the FDA can approve it.
The details relating to these 3 favourable protocols that has been obtained through the freedom of information act, shows that the number of people who actually completed the 4-6 week long trails that were used by the FDA to approve prozac was only
286 PATIENTS.
One of the protocols known as protocol 27, stated “fluoxetine was not shown to be consistently different than placebo” but it was still used to approve prozac.Criticisms of this study were made by Walter Sloboda a scientific investigation psychologist in an in-house FDA memo .The antidepressant Tofranil had been given in addition to prozac in the trail without this being recorded yet it was still put forward as a reliable measure of prozacs efficacy.He also reported that several cases of laboratory findings were ignored,entailing risk to patients.
One such serious health concern from protocol 27,that was ignored, was the hospitalisation of a woman immediately after starting the trail.No follow-up information on this was recorded.The trail methods of this protocol were again criticised in a letter from the FDA `s director of the division of scientific investigation in august 1984 stating it “ had several departures from Food and Drug Administration regulations or commonly accepted drug investigational practices”
In another trail by Jay B. Cohn M.D. psychiatrist from university of California,it came to light that he failed to declare a history of alcoholism in 3 patients ,1 of whom had cirrhosis of the liver . It was also found out that Cohn had failed to obtain written informed consent and then “backdated the consent form.”
Hardly an ethical or reliable source of drug research.Despite being heavily criticised by the FDA for this it was still published in the `journal of clinical psychiatry` as part of an Eli Lilly sponsored symposium as proof of the efficacy of prozac
In other trails yet more flaws exist in that patients were taking a range of psychiatric medications in addition to prozac.For example trails led by James D Bremner MD,a psychiatrist in Olympia Washington, about a third of his patients were taking tranquilizers or sedatives which can only have clouded the real effects caused by prozac.
The FDA`s November 1984 “in-house meeting on fluoxetine” brought together a “flaw in the experimental design and execution of fluoxetine studies.”It was discussed how patients who had not been responding well initially in the drug trail were being switched from what they had been given up until then.This was a total breach of proper practice.Again hardly a proper basis on which to approve a drug.
http://www.encourageconnection.com/art01.html
meds:
http://www.laleva.org/eng/2005/09/psychiatric_drugs_chemical_warfare_on_humans.html
http://www.laleva.org/eng/2004/04/resolving_schizophrenia_bipolar_disease_obsessivecompulsive_disease_and_depression_without_drugs.html