What it’s all about…

Sometimes I forget why I do this, but then I remember, it’s not really about big business, drug marketing and corruption – it’s actually about people – people and their stories.

And you will hear the same stories literally the world over. The experiences are so similar it’s frightening. It doesn’t matter if you’re from London or New York; Birmingham or Melbourne; Dublin or Bahrain – if you have had problems taking, or withdrawing from, an SSRI, then people’s experiences will be all too similar.

And how many of us might suffer?

To begin with, withdrawal was not even mentioned on the early Seroxat PILs. Later when it was mentioned on the PIL, it was rare – 0.2%. Then on 25 June 2003 the PIL was quietly rewritten by Glaxo and withdrawal became a likely issue for 25% of patients. Yes from 0.2% to 25% – overnight.

And today the estimate (on the PIL) stands at “3 out of 10” – that’s 30%. I wonder what the real figure is?

Here are a couple more stories from the testimony given to the FDA hearings last December in America:

My name is Andy Vickery. I am a trial lawyer from Houston, Texas. Many of the people that you have heard from or will hear from, the victims of SSRI-induced violence and suicide, are my friends and clients. I wish they didn’t have to meet me in that way. I wish that I didn’t have to answer the question for them of where is the justice in the “justice for all” when they have lost someone close to them. I am supposed to compress about twelve year’s worth of my professional life into three minutes today, and I don’t know how to do that really, so let me make as many points as I can.

First, Dr. Clayton is right, do no harm — no harm. Don’t balance that you might maybe do some benefit to someone else — do no harm.

Secondly, I have provided you with a written statement that’s called “Needle in the Haystack.” They are not my words. They are the words of Charles Beasley at Eli Lilly in 1990 when they looked at this, and he said: “If you want to see if this is a real phenomenon, don’t look at the clinical trial data. It’s not there. You won’t find it there. It’s like looking for a needle in a haystack because these trials were not designed to measure it.”

What have you done for the last two years?

You have done precisely that, you have looked for the needle in a haystack, in a place where it is not likely to be in the first place. You have looked at a hundred thousand patients, and you have ignored the millions of patients.

Why do you have a MedWatch system? Why did you abandon some years ago the FDA causality algorithm that was used to assess causality?

Assess causality on these “anecdotes.”

These are not anecdotes, and these deaths are neither significant statistically, Dr. Stone, or otherwise.

Why did you abandon the FDA causality algorithm that you used to assess these events when Dr. Temple and Dr. Laughren started with the FDA?

Because if you take the published literature, if you take Anthony Rothschild’s article in `91 that shows akathisia and suicide, and if you subject it to the causality algorithm that the FDA itself used, it will show that it is highly probable that the akathisia and the suicidality experienced by the three patients that these Harvard psychopharmacologists rechallenged was probably caused by the Prozac. That was 15 years ago. Fifteen years ago when this Committee was summoned, the issue was swept under the rug, and a lot of people have died since then. I wonder, as I read the report, why you have been summoned days before Christmas on short notice this year?

The FDA says the Advisory Committee isn’t even going to be asked for advice. You might ask yourself, Why are we being summoned? Are we being used in some way before the change in the Congress in January? What’s going on here?

(Applause.)

MR. VICKERY: In 1991, this gentleman right here (pointing at Committee member) before he became a paid expert for Pfizer and GSK wrote, “From making the cure more grievous than the disease, good Lord, deliver us.”

You deliver us.

and

I am a little vertically challenged here. Good morning ladies and gentlemen. My name is Kimberly Porto. I have asked my parents Barbara Bedina and Raymond Bedina, and my sister Cara Bedina behind me to join me here at the podium.

On October 9, 2003, my brother Raymond E. Bedina died of Lexapro®-induced suicide after taking Lexapro for only nine days. Ray was just 32 years old when he passed. Those who knew Ray remember his loving, giving personality, his great sense of humor, his warm smile that would take you in and hug you, and his insistence that his friends and his family were more important than anything else. Ray was the kind of brother, son, and friend you felt lucky and proud to have. He was successful at everything he tried. He excelled at his career and he excelled at life. Ray was prescribed Lexapro by his primary care physician for fatigue associated with anxiety. He had no history of depression or any other mental illness.

At the time he was prescribed Lexapro Ray was feeling stressed about work, but only because the current demands of his job were not allowing him to spend as much time with his family and friends as he would like. He was becoming concerned that he hadn’t had the opportunity to settle down and start a family as many of his close friends had at that point in time.

Within a couple of days of starting Lexapro, Ray began to experience very unpleasant side-effects. When his coworkers and friends noticed that he was not himself and not feeling well and asked him what was wrong, he told them that he had recently began talking a new medication called Lexapro and that he felt that it was making him feel ill.

Within five days on Lexapro, I noticed my brother pacing back and forth through my house, uneasy, agitated, and anxious. His hands were shaking. We knew something was wrong. Only in retrospect do we now understand that what he was experiencing was an adverse reaction to the drug Lexapro. The next day Ray told a friend that he thought the Lexapro was making him feel weird, and he had very strange thoughts running through his mind. Within seven days of taking Lexapro, Ray was thinking about suicide. He expressed thoughts about hurting himself.

Two days later, he went to a hotel alone. He never said goodbye to anyone. My sweet, loving brother who had always sought peace and expressed strong views against suicide and violence ended his life by cutting himself with a knife and poisoning himself with pills.

Ray died alone.

I am sure that he was also very scared and very sick. My brother never should have suffered and died that way. Over the past fifteen years, too many tragedies like this have destroyed too many lives. Too many families, like ours, are broken and struggling every day with the pain and anguish of losing a loved one in this horrific manner. My brother and his doctor deserved to know the truth about the suicide risk associated with Lexapro. Had Ray and his doctor been warned that Lexapro can cause the emergency of akathisia and suicide, Ray would be here with us today, and my family wouldn’t have paid the ultimate price for your failure to warn. The American people have a right to know that SSRIs can cause suicide, and that holds true regardless of whether you are age 5 or 75.

We have a right to make informed decisions.

3 Responses to “What it’s all about…”

  1. Jeffrey Dach MD Says:

    According to Dr. Irving Kirsch in Prevention & Treatment, “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.

    Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

    1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

    2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

    3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

    4) Miscoding suicidal events as “emotional lability”, and homicidal events as “aggression” to hide suicidal events from regulators.

    5) False attribution of suicide to the placebo arm.

    6) Hiring ghost writers to make the medical articles more favorable.

    7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

    For more information and links see my Paxil, Prozac, and SSRI Induced Suicide Newsletter

    Jeffrey Dach MD

  2. anthony Says:

    wow, i just started lexapro. and now im going off of it tomorrow. damn, i thought this was gonna help me to😦

  3. admin Says:

    Anthony – please make sure you talk to your Doctor if you’re going to stop any meds – by all means show him/her the information and then discuss it and let your feelings be known.

    Good luck


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