Bob Fiddaman Revisits The Seroxat Yugoslavia Trials…


http://fiddaman.blogspot.ie/2015/08/mhra-missing-key-seroxatpaxil.html

Tuesday, August 18, 2015

MHRA Missing Key Seroxat/Paxil Withdrawal Information

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You may remember that back in July I wrote about the Yugoslavia paroxetine (Seroxat UK, Paxil US) trial (here and here)

In 1988 GSK, then SmithKline Beecham (SKB) sponsored clinical trials in Yugoslavia. The purpose of the trials was to show how Paxil (known as Seroxat in the UK) could, when stopped, cause a relapse in depression. SKB never took into account that those relapsing (after stopping Paxil) could have been suffering withdrawal symptoms.

With the results they wanted, SKB then provided the FDA with apparent evidence that showed patients staying on Paxil continued to enjoy a normal, “depression free” life, but that those abandoning the drug would suffer relapse back into a depressive state.

Seeing as Glaxo are a British pharmaceutical company I decided to write to the British drug regulator (MHRA) to request, under the freedom of information act, information relating to Glaxo’s trials in Yugoslavia.

My email to them read…

Dear Sir/Madam, 

Pursuant to the federal Freedom of Information Act, I request access to and copies of a a clinical trial in Yugoslavia that commenced in 1988.

The trial was, as far as I am aware, sponsored by SmithKline Beecham (SKB) and was known as the “Yugoslavia trial” or “relapse trial.”

I am specifically requesting the protocol for this particular clinical trial and whether or not that protocol included information and/or guidance on Paxil withdrawal.

I look forward to your reply within 20 business days, as the statute requires.

Thank you for your assistance.

Sincerely,

— 
Bob Fiddaman

The MHRA have now answered this request.

Are you holding your breath folks?

The current Chief Executive of the MHRA is Dr. Ian Hudson. Before joining the MHRA, Hudson was the World Safety Officer for GlaxoSmithKline (then SKB)
Later this year GlaxoSmithKline will be defending allegations in the UK regarding Seroxat withdrawal. One of Glaxo’s experts to be called will be Dr. Rashmi Shah. Shah was employed by the MHRA between 1987 and 2004. Positions held were Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.
You can draw your own conclusions.
Bob Fiddaman.
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One comment

  1. kiwi

    Rather surprisingly I was reading this exact court testimony by Peter Breggin myself today.
    http://breggin.com/index.php?option=com_content&task=view&id=77

    I have also been reading recently how Prozac was approved and marketed by Lilly using bribery and fraud. I started to think to myself i wonder if Lilly provided a BEHAVIOUR TEMPLATE for the rest of pharma.

    I was right it couldn’t be more blatantly obvious there it is right in the middle of ’29’…..

    “The FDA official revealed the test standards Eli Lilly used in order to get Prozac approved, effectively saying that SKB should copy the Lilly standards and that all would be OK. Feeling elated that FDA’s top regulator was advising them on how to get around the suicide issue, the Ph.D. seized the moment.”

    Check it out for yourself:

    Suicide Issue Delay’s Consideration–but FDA Finally Approves Paxil
    29. Paxil’s fate before the FDA was to be decided on October 5, 1992.This date was much later than originally anticipated. The delay was caused by public pressure. There had been press reports that Prozac, originally appearing on the market in 1988, had caused many suicides. FDA was thus compelled to review Prozac and–obviously–considered it in their own interest to tread softly before approving additional SSRI’s for the market. Condemning Prozac and acknowledging the suicide issue, however, would suggest in many quarters that FDA was to blame for allowing a dangerous drug on the market in the first place.

    Few bureaucracies admit they are wrong, and all have a tendency to herald the status quo.

    Thus while assuring Congress and the media that they would thoroughly investigate the recent Prozac allegations, the FDA was actually in cahoots with the SSRI manufacturers on the suicide issue. On October 3, 1990, an FDA official, the Director of Neuropharmacological Drug Products, telephoned SKB headquarters. He asked to speak to SKB’s Regulatory Affairs director, a Ph.D. The call was made at a location that could not be traced back to the FDA official’s office.
    This person making the call was the senior FDA official responsible for Paxil’s application. The official made clear to SKB his purpose. It was not to “lay down the law” and ensure SSRI testing was refined. It was to tell SKB how to get around the suicide problem for Paxil’s upcoming application–and further not to worry. At the time of this telephone call, October, 1990, the FDA was still a year away from the ultimate September 20, 1991 hearing that would determine FDA’s position on SSRI’s and suicide. But the issue had already decided in the eyes of the FDA. Getting to the point in this October 3, 1990 telephone call, the FDA official assured SmithKline that “the Division does not see it as a real issue, but rather as a public relations problem. “The “it” was the relationship between Prozac and violence-ideation and suicide-ideation. The FDA official made clear that for Paxil–his agency would short cut the process and not require scientific precision for evaluating the drug’s connection to suicide. He told the SKB agent that FDA did not desire a “voluminous” submission of Paxil suicide data. The FDA official told SKB to keep the submission brief, that FDA “…(did)…not want to review something that large.” The FDA official offered tips to the Ph.D. on how SKB could get around the suicide issue. He told him SKB “should” key in on Dr. Teicher’s article regarding suicide ideation (note: it was Teicher’s article in a national medical journal that first gave credence to Prozac’s suicide connection).

    The FDA official revealed the test standards Eli Lilly used in order to get Prozac approved, effectively saying that SKB should copy the Lilly standards and that all would be OK. Feeling elated that FDA’s top regulator was advising them on how to get around the suicide issue, the Ph.D. seized the moment.

    He asked the FDA official whether SKB’s point person on the suicide issue could work with him (FDA official) to ensure that SKB’s submitting document was correctly prepared. The FDA official “said that would be fine.” Thus, instead of being a critical watchdog for the public welfare, the FDA simply went into the applicant’s camp and acted as SKB’s intermediary to maneuver Paxil’s application into safe waters for the drug company. Before hanging up the telephone, the FDA official once again reassured SKB they were all just playing the PR game on suicide, emphasizing “that the Division does not think…(suicide and SSRI’s)…is an issue, but…(that)…it needs to be addressed.” Paxil’s application eventually came to the fore. As with many new drug applications, the FDA convened a panel of non-governmental experts to determine Paxil’s fate. It was on October 5, 1992, that the FDA convened the “Psychopharmacological Drugs Advisory Committee” (or “committee”) to consider Paxil’s safety and efficacy and fitness for market. All six (6) members of the committee were affiliated with the pharmaceutical industry, and required “conflict of interest” waivers in order to sit on the panel.

    Shame on the FDA!!
    And 100% of the members had ties to pharma …i guess that means that marionette in New York was in that group of 6 that approved paxil. I wonder how extensive Marionette Leibermans strings actually were? Did you have a string to GSK Jeff ? What was it Jeff 100 grand, 200 grand ?

    Healy in his book Pharmageddon pg 214-215 alludes to the trial fraud [insert mine]…

    “Following Lilly’s lead GSK in the case of paxil also took pre-study suicides and suicide acts from paxil trials and dumped them into the placebo group against regulatory rules. The FDA noted this was happening and did nothing, and again has offered no explanation since for their oversight….when the British regulator caught up with this maneuver 13 years later, in 2003, and asked GSK for their paxil suicide data, making it clear companies should not move prestudy suicides into the placebo group as they had been doing, GSK instead took suicides recorded after the trials of paxil had concluded [no doubt they must have CT these poor people] and coded them placebo, even including in the placebo group a patient who had committed suicide after having started Prozac. [i can only assume he started prozac as the paxil CT was so traumatizing he presented to the doc for help -as you do, and so given prozac..as we all know a switch often will not cover the wdl or in this case the CT so he then went and committed suicide, no surprises there]. The MHRA did not object. “…………Healy then goes on to state “These manipulations are both a real problem and possibly a criminal offence..”

    Healy explains how Lilly airbrushed its suicidal hazards out of existence. In the trial, 6 suicides on prozac versus zero suicides on the placebo. “Lilly had taken a suicide that had happened before the trial had started and filed it under the heading of placebo, in a manner that contravenes regulations and seems close to being fraudulent.” “The single suicide was very important to the company, and maybe to the FDA, because its addition to the calculation meant the increased risk on Prozac would not be statistically significant and if not statistically significant 6 suicidal acts on Prozac vanished.” [What the…] “The company knew that medics across the board could be depended upon to agree with this view of significance.”
    Healy asserts we seem to have entered an Alice in Wonderland world in which things are whatever the Red Queen says they are.
    So how does a doctor cope when encountering an iatrogenic death, Healy says “..for most doctors the anecdote told repeatedly by a drug company, will continue to work.”
    Nothing like avoiding a double dose of cognitive dissonance.

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