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nz11

Gagging orders on Healy but not Breggin

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nz11

Here is a very informative post by Altostrata.

 

As far as I know, paxilprogress.org had nothing to do with getting withdrawal warnings put on Paxil and other antidepressants. The first warning was put on Paxil December 14, 2001, as a result of a class action lawsuit initiated August 19, 2000. Also see http://usatoday30.us.../paxil-suit.htm

This is how Peter Breggin became famous.
 
Labeling on other new antidepressants followed, per a 2004 FDA decision.
 
From my correspondence with the FDA:

"Information on the Paxil discontinuation syndrome was added to the drug label on December 14, 2001. A direct link to the December 2001 label is provided below for your review: http://www.accessdat...20031s29lbl.pdf."
 
Paxilprogress.org was created 2001-06-20, according to whois http://whois.domaint...xilprogress.org

 

.....................................................................,,...........................................

Sorry about the title i didnt know how to title it ...

In trying to satisfy myself that i understand what is going on and can try to articulate it i have some questions to ask.

See posts below.

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nz11

In this link Breggin reports on his access to and revealing of the 'paxils clinical trials' in that section of the lawsuit details :

Legal brief for the resolved Paxil withdrawal suit

 

Am i  correct in stating Breggin was not gagged by gsk which is why this can now be put into the public arena ...unlike Healy who saw the same info but had a gagging order put on him by gsk in court??

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Altostrata

I don't believe there is a gag order on David Healy, except that he settled his breach of promise case with the U of Toronto and may be under some restrictions to talk about that.

 

Please supply links and citations, markca.

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nz11

Here is my other question from the first post info

 

Was Breggin the plaintifs rep in the Grair vs gsk case or was Breggin involved in a separate case ie is the nguyen and farber a separate one .

or is Grair and N&F one and the same.

 

Just a bit confused here. If someone could enlighten me that would be great.

 

Let me put it another way if i were to say this ....

"The first warning was put on Paroxetine December 14, 2001, as a result of a class action lawsuit against GSK initiated August 19, 2000 (refer Grair vs GSK Litigation). Psychiatrist Peter Breggin, M.D. was the plaintiff's medical expert and worked closely with the attorneys in formulating the suit.  "

...would i be correct?

 

Would i also be correct in stating that gsk did not put (manage to put) a gagging order on breggin ...which is why we can read his reporting on the clinical trial data

Legal brief for the resolved Paxil withdrawal suit

 

...unlike Healy who had a gagging order put on him by gsk in court??

 

Are you sure the link to the grair case above is the right one b/c that is being settled in 2013 it appears to me ...seems a long time to wait for settlement from a 2001 outcome? ...i am sure i am probably missing something ..i am just trying to satisfy myself i understand what occured ...

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Altostrata

I think you need to spend some time with Dr. Google to answer those questions.

 

Re Grair -- look at the link yourself. It is regard to final distribution of the award.

 

What makes you think there's a gag order on Healy?

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nz11

I thought i had read it somewhere ...i will get back to you on that one.

Also and i wish that i had printed and filed it

 

  also i recall him saying something recently along the lines of ' i have seen info that other people cannot see.'....or something similar.

 

I'll see what i can find.

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nz11

Found it ....maybe i'm inferring the wrong thing here but i will highlight the sentence that made me assume this.

 

Dependence on Paroxetine (Paxil/Seroxat)
Statement by David Healy MD FRCPsych
I have been asked to confirm and comment on evidence relating to withdrawal reactions suggestive of physical dependence on paroxetine, observed in studies on healthy volunteers, carried out in the 1980s by SmithKline Beecham.
In the course of a recently settled legal action (Tobin v SmithKline, Wyoming, 2001), I acted as an expert witness for the Plaintiffs. As part of the discovery process I had sought and was granted access to SmithKline’s Beecham’s healthy volunteer archive at Harlow. My concern had been to scrutinise those records for details of possible agitation and suicidality in healthy volunteers taking paroxetine. These were present, but at least as striking was evidence from these studies about dependence on paroxetine. A detailed expert report was prepared for the plaintiffs’ lawyers in this case, which includes details of studies undertaken by SmithKline Beecham that fully substantiate concerns I communicated to the UK Medicines Control Agency in letters of 7th and 19th June 2001, the essence of which was also accurately reported in The Guardian newspaper (11 June 2001)
I regret that I am under a confidentiality order in regard to this material and am not able to disclose it to this appeal. However, I can confirm, and am prepared to testify to the substance of the points raised in the following exchange (in my testimony in Tobin v SmithKline) between Mr Charles Preuss, the attorney for SmithKline, and myself.
Healy: Yes, but there's a withdrawal syndrome from Paxil, including agitation, abnormal dreams and nightmares that comes through in spades in these healthy volunteer studies.
Preuss: You're saying Paxil is still active for three months?
Healy: In up to 80 percent of the volunteers on this drug for only two weeks produces withdrawal syndromes in these healthy volunteers. I'm saying in my clinical experience I've seen people on this drug for short periods of time and I've seen them have troubles three months later, yes.
My concerns about paroxetine extend far beyond the results of these studies on healthy volunteers. In the 1990s, after its release on to the market as an antidepressant, SmithKline Beecham put paroxetine into clinical trials – exemplified by the study reported by Montgomery & Dunbar, 1993 - that involved a randomised discontinuation design. The difficulties experienced by patients on randomisation to placebo were then interpreted by SmithKline Beecham as evidence of new illness episodes, and the company has subsequently responded to enquiries about the risk of withdrawal reactions and physical dependency, typically by stating that any such problems experienced by patients are simply a recrudescence of their original nervous problem. Basic pharmacological principles, epidemiological studies on depression, as well the evidence from their own healthy volunteer studies strongly suggest that such an interpretation of these data was and is quite unjustified. Against this background SmithKline Beecham launched paroxetine in the UK with disclaimers on the datasheet to the effect that, as with any drug acting on the brain, some care needs to be taken on discontinuation. The data available to SmithKline before launch indicated problems occurring at a significantly greater rate and to a markedly more severe degree than any psychiatrist at the time would have had reason to expect either from an antidepressant or from such warnings.
Post-marketing surveillance surveys and other studies undertaken since have indicated much greater withdrawal problems with paroxetine than with the previous generation of tricyclic, MAOI and non-tricyclic or non-MAOI antidepressant drugs. A randomised controlled trial undertaken with funding provided by Eli Lilly (Rosenbaum et al, 1990
, indicated rates of problems on discontinuation of paroxetine in over 30% of patients with many patients having multiple symptoms, including many novel and disturbing symptoms. For Dr Wheadon and the company therefore to characterise paroxetine withdrawal reactions as very rare, transient, mild and/or virtually impossible to detect and distinguish from underlying psychiatric illness is simply an untenable position. It follows that I have real concerns about SmithKline promoting paroxetine for the prophylaxis of depressive disorders and other psychiatric illness, on the basis of data that are more sensibly and credibly explained in terms of physical dependence and withdrawal symptoms.

David Healy MD FRCPsych.

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cymbaltawithdrawal5600

I read it as he was allowed to look at the "healthy volunteer archive" but was prevented from discussing it (it was, after all confidential information) He was trawling the archives of "those records for details of possible agitation and suicidality in healthy volunteers taking paroxetine. These were present, but at least as striking was evidence from these studies about dependence on paroxetine."

 

He had not expected to find the info on dependence. He was not prohibited from talking about that, and was "prepared to testify to the substance of the points raised in the following exchange (in my testimony in Tobin v SmithKline) between Mr Charles Preuss, the attorney for SmithKline, and myself." Said exchange quoted above.

 

What are you attempting to understand, markca?

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nz11

Thanks Cymbalta, I think im perhaps confusing myself. Perhaps i should just shut up.

 

I found the above info from Alto very informative and something i need to 'lock in'

Basically i am preparing letters to complain/inform others who,... shall i say ..have.lots of letters after their name.  As such i don't want to make a mistake .

 

Let me put it another way if i were to say this ....

"The first warning was put on Paroxetine December 14, 2001, as a result of a class action lawsuit against GSK initiated August 19, 2000 (refer Grair vs GSK Litigation). Psychiatrist Peter Breggin, M.D. was the plaintiff's medical expert and worked closely with the attorneys in formulating the suit.  "

...would i be correct?

I think this is wrong because Breggin was not involved in the Grair case. I think Alto is right i need to do more homework. The above links to breggin has confused me breggin became famous for a different litigation ..not the one which resulted in the first warning being placed.

 

Hey Cymbalta i appreciate your help.

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cymbaltawithdrawal5600

Markca,

 

If you look in this topic Alto has bumped several threads for you. Happy reading!

 

Did my interpretation help or hurt? You seem to have resolved Breggin's involvement with when and where.

 

(PS save your fingers, CW will do :) )

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nz11

CW your comments are more than helpful ...as always.

Thanks to the team for the bumps ...wow so much great stuff here ...its difficult to know where to look.

 

As this is my thread i dont need to worry about getting off topic.  i dragged the 'bad psychiatrists name and shame' thread off topic and i feel guilty about that so i have a final note i'll mention it here instead of there as the discussion ended up on pssd. I have just noticed that you are a woman from your statement in another thread. Difficult to discover at times on these sites who is who. My own opinion at this stage is woman are not as damaged by pssd as men. but perhaps come out of this mess with a chance of  thyroid issues more than men.

Not being sexist here just tabling what is my limited observation rightly or wrongly.

 

You are welcome to respond to this or not.

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Altostrata

That's not a gag order, markca. Healy was given access to information then considered proprietary subject to certain conditions.

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cymbaltawithdrawal5600

 

I have just noticed that you are a woman from your statement in another thread. Difficult to discover at times on these sites who is who. My own opinion at this stage is woman are not as damaged by pssd as men. but perhaps come out of this mess with a chance of  thyroid issues more than men.

Not being sexist here just tabling what is my limited observation rightly or wrongly.

 

Click on anyone's avatar or their name and you are whisked to their profile. Almost all posters reveal their sex and an approximate location.

 

I had more SD before my CT and pssd up until a month ago, which would make it 2 years in duration (plus at least 6 of the 8 yrs of meds were on the SNRI and I had it then). Don't ask me why that resolved itself so quickly, I do not have a clue. But is that not encouraging?

 

You cannot make guesses on the prevalence or distribution according to sex for pssd and thyroid problems based on the very minute groupings of people on these sites. It is not scientific when it is anecdotal I'm afraid. So your statement that your observations are based on a limited sample is correct.

 

I have read stories of some women being very damaged by sexual disturbances as a result of meds but the whole thing is different for men and women. Women have more 'global' worries, men seem to focus narrowly on that one particular aspect. Some men, anyway. I just wish the whole subject on treating it were not so full of bunk and snake oil. Can't even research it properly, I keep finding stuff where 'someone has the answer!' and it turns out to be anecdotal and involves eating pills. I'd like to be more supportive when the subject comes up and I can't beyond the statement "Everyone heals eventually".

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nz11

Thanks for the reply CW .

Hey  and thanks for the tip on finding out peoples genders. I'm just a newbie after all.

Of course as i said before that is wonderful you recovered.

 

I'm not convinced that everyone recovers, i'm sorry if that is at odds with the way you see it.

I do thankyou for the reply though.

Oh by the way Happy New Year to you and the rest of the awesome mods here...we get the New Year  first and its summer hooray for that!

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nz11

That's not a gag order, markca. Healy was given access to information then considered proprietary subject to certain conditions.

Thanks for the clarification

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cymbaltawithdrawal5600

Thanks for the reply CW .

Hey  and thanks for the tip on finding out peoples genders. I'm just a newbie after all.

Of course as i said before that is wonderful you recovered.

 

I'm not convinced that everyone recovers, i'm sorry if that is at odds with the way you see it.

I do thankyou for the reply though.

Oh by the way Happy New Year to you and the rest of the awesome mods here...we get the New Year  first and its summer hooray for that!

 

Reading from the top:

 

You're welcome!

I try to help!

Thank you!

That's ok, we can agree to disagree.....

YW!

HNYTY! and: OK, watch it buddy, don't rub it in :) and celebrate wisely..... (Although it is a bit too hot in FL at the moment, winter is now feeling like summer) I like winter here better.

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btdt

I think I spoke to this a bit here:

It may actually be where you originally copied the first bit you have I don't know how you missed the rest. 

 

http://survivingantidepressants.org/index.php?/topic/7513-paxil-progress-is-closing/?p=115345

 

Keep in mind that proprietary privilege is the same thing as a gag order if you have the right lawyers... and companies now have the same privilege as human being in courts in the US lawyers mess with the law if you get the right lawyer and the right judge well the sky is the limit in my humble opinion money allows all sorts of things to pervert justice. Like the political process you need money to play so smaller law firms cannot afford to stay in court for decades waiting to get paid while pharma lawyers with deep pockets can stay forever... only the rich can play and we wonder why folks don't care to vote why would we want to play in a game where we have no power... our power is here in this event... to take or not take the drugs... it starts and pretty much ends there ... once you take it end of power. Your screwed. 

 

Back on topic. This is what I find interesting about this situation:

""For many years after the fixed trial, plaintiffs, attorneys and even the FDA remained unaware of many of the documents Breggin had discovered and/or evaluated. Then in 2004, an anonymous individual sent the documents to the British Medical Journal (BMJ), who published an article about them and also distributed them. When Eli Lilly forced the BMJ to apologize for suggesting that the documents had "disappeared" while in Eli Lilly's care, Breggin wrote an unpublished letter to BMJ explaining how the documents had indeed disappeared (available below). Though criticizing BMJ for saying that the company had in effect hidden the smoking guns, Eli Lilly never actually contested the allegations surrounding the documents -- that the drug company had withheld evidence that Prozac caused suicide.  

http://www.breggin.c...ask=view&id=110"

 

Every now and then somebody upsets the apple cart in such a way there is no going back (like us taking the drugs) poetic really. 

 

I know you draw a distinction between prozac and paxil the when and how of it all but I don't both drugs I took a short time both caused devastation in my life upsetting my apple cart and both times leading to further drugging which got me to effexor and here today. For me what can be said of paxil can be said of prozac and I think of them as the same thing. Though my reaction to prozac was much worse nothing was known about it in those days and nobody noticed ... I was like you told it would stop pain in my leg... that it was an anti inflammatory told this by a specialist ... that is what I told the hosp when I went there suicidal I was taking only an anti inflammatory for leg pain.  I doubt it would have made much difference had they know it was prozac and nothing was known about it then by doctor it was when it first came out but maybe it would have.  I was such a mess I could barely keep a decent thought in my head and trusted the doc who trusted the drug rep... and around we go. 

 

There is another who thinks the same that all these ssri drugs are the same he has an online book here:

 https://detenganlava...rma-insider.pdf

 

He too says what is true of prozac is true of the other ssri type drugs.  

He worked for pharma when the prozac was trying to get on the market and admits bribing was part of it.  He has an interesting take on it all you may find something in there related to the timeline you interested in. 

I found his online book interesting the bit about auto immune connections to these drugs in particular as I did not find it  most other places.  I have looked for it too as I have fibro since taking prozac years ago. I have read a lot of books and looked for a connection finding none till this book.  He says he can't get a publisher so he put it online. 

 

There is a book called Our Daily Meds 

It shows how the industry works. I recommend it. 

peace

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btdt

We have something in common both of us were put on these drugs for pain and here we are. 

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