Seroxat/Paxil addiction

I hope the title of this post has caught your attention.

While the drug companies, the World Health Authority, the FDA and the MHRA all sit around and agree what ‘addiction’ means to them, in the real world we know the truth.

For hundreds of thousands of people around the world, Seroxat addiction is all too real.

You want to stop taking Seroxat, but when you try to stop, you find you can’t – the physical and mental withdrawal symptoms can include akathesia, agitation, mania, psychosis, self harm, suicidal thoughts and actions, violence, fear of loud noises, electric zaps of the head and body, thoughts of homicide, profuse sweating, disturbing nightmares, lack of empathy toward other people, anger, severe memory loss, nausea.

Not everyone who takes Seroxat will be affected – maybe 35%, maybe 40%, maybe 50%… the fact is that no one knows because Glaxo has never bothered to do any research into the level of Seroxat withdrawal problems nor any research into why some people suffer so badly.

The bottom line is Glaxo actually doesn’t care – it takes the line that there is no problem – Seroxat is safe and it’s easy to stop taking it.

However, having experienced Seroxat addiction myself, I can confirm how real the addiction is. As can the hundreds of people who have contacted me with their own horror stories.

Glaxo dismiss us – there is no place for ‘anecdotal’ evidence in their world – you see the experiences of real patients in the real world are based on personal accounts rather than facts or research. The thing is, that no matter if you’re from the UK, Europe, the USA, Australia or the Far East, the withdrawal stories are all the same. But Glaxo ignores the fact there is a problem and has NEVER bothered to undertake any research in Seroxat withdrawal symptoms.

Furthermore, Glaxo has never bothered to undertake any research into the best way to taper off Seroxat.

Of course you have to suspend disbelief in order to to take Glaxo’s ‘research’ seriously. Glaxo has a long history of rigging drug trials and hiding negative data when they apply for drug licences. Take the infamous Study 329.

In October 1998, an internal, confidential SmithKline Beecham document about studies 329 and 377 was issued. Studies 329 and 377 tried to prove Seroxat/Paxil worked in children. In summary it said “… the data do not support a label claim for the treatment of Adolescent Depression… efficacy had not been demonstrated.” Specifically about Study 329 “…the study failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures.”

In other words – Seroxat didn’t work.

About Study 377 we read “… failed demonstrate [sic] any separation of Seroxat/Paxil from placebo.”

In other words – Seroxat didn’t work.

In March 1999, a fuller manuscript of Study 329 being prepared for publication. This was written by Sally K Laden but was attributed to Marty Keller, Neil Ryan and colleagues. The conclusion reads “Paroxetine is a safe and effective treatment of major depressive disorder in the adolescent patient.”

By March 2001, internally at least, SmithKline Beecham seem to have understood what the data from Study 329 really said. In an email to PR company Cohn and Wolfe, SKB said: “Originally we planned to do extensive media relations surrounding this study [329] until we viewed the results. essentially the study did not really show Paxil was effective in treating adolescent depression, which is not something we want to publicize.”

However, by August 2001 SmithKline Beecham Paxil Product Management was writing to all sales representatives selling paxil and telling them about Marty Keller’s “cutting edge, landmark study [329] which was the first to compare efficacy of an SSRI and a TCA with placebo in the treatment of major depression in adolescents. Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression.”

And Glaxo won’t listen to me and others but thinks I should take its ‘research’ seriously?

Over the years previously secrets documents have slowly come into the public domain which prove how shameful Glaxo has been in it’s lies about the efficacy and safety of Seroxat. Everytime there is a court case we find out a little more.

That’s why I’m looking forward to the High Court case in London and seeing all the previously secret documents that will no doubt become public over the course of the trial.

If you want to learn more, just type ‘Study 329’ into the search box on the left…

Glaxo Is STILL testing Paxil on 7-year-olds despite proven suicide risks

This story just shows little Glaxo cares and what a thick skin the drugs giant has. It’s from BNET UK by Jim Edwards.

Bob Fiddaman over at Seroxat Sufferers has also picked up on this and gone straight for the jugular (in his usual fashion!) writing to Glaxo demanding a full explanation: “As a matter of public record I would like either GlaxoSmithKline UK or GlaxoSmithKline Japan to explain why this study has been put in place. In other words, what is GlaxoSmithKline’s motive behind this study?”

Bob and I have been doing this for all too long and I don’t think either of us will be holding our breath waiting for any sort of reply from Glaxo.

Here’s the Jim Edwards piece:

It was established years ago that Paxil carries a risk of suicide in children and teens, but GlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan. It’s not clear why the company would want to draw more attention to its already controversial pill, but it appears as if GSK might be hoping to see a reduced suicide risk in a small population of users — a result the company could use to cast doubt on the Paxil-equals-teen-suicide meme that dominates discussion of the drug.

GSK didn’t immediately respond to a request for comment. A staffer on GSK’s trials hotline confirmed the study was ongoing, however. The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo.

The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.

The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.

Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills. [Or maybe not in the case of Paxil – see this story].

To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.

About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.

The trial will wrap up in September.

Related:

• Glaxo, Paxil and the Catholic Sex Abuse Cover-Up: Drug Implicated in Priest’s Suicide
• Jagged Little Pill: When Drug Companies “Forget” to Mention Suicide Risks
• “CASSPER” Was GSK’s Friendly Ghostwriting Program on Paxil

Conflicts of interest – Charles Nemeroff take a bow!

As you all know, Charles ‘Chuck’ Nemeroff, the controversial former Emory University psychiatry department chair, has been named chair of the psychiatry department at the University of Miami School of Medicine. [My Nemeroff back catalogue is  here, here and here. Read even more here, here and here.]

It was only October last year that Chuck was forced to resign from Brown University.

The Miami Herald reported:

“On Thursday, Pascal Goldschmidt, dean of UM medical school, called Nemeroff ‘an extraordinary psychiatrist and scientist. . . . He got into serious trouble on disclosure on conflict of interest.’ “Goldschmidt said he had read investigative reports from Emory about Nemeroff’s activities and found nothing to indicate that payments the psychiatrist received had in any way influenced his research results.

Check out this list of some of Chuck’s ‘activities’ from CL Pysch…

Pharmaceutical and Clinical Research Company Scientific Advisory Boards

Abbott Laboratories
– Consultant, Abbott Laboratories, Diagnostics Division, 1986-1992.
– Research and Education Advisory Board for Psychiatry
– Member, 1990 – 2006
– Executive Board, 1991 – 1993, 2003 – 2006
-Antidepressant Advisory Board, 1991 – 1992

ACADIA Pharmaceuticals Clinical Advisory Board
– Member, 2000 – 2006.

AstraZeneca Pharmaceuticals
– Psychiatry Advisory Board, 1997 – 2001.
– Chairman, 1999 – 2002.
– Neuroscience Scientific Advisory Board, 1999 – present.

Bristol-Myers-Squibb
– Antipsychotic Advisory Board, 2003 – 2006.
– Antidepressant Advisory Board, 2003 – 2006.
– EMSAM Advisory Board – Chairman, 2005-2006.

Cephalon Pharmaceuticals
– Scientific Advisory Board, 2002

Comprehensive Neuroscience, Inc.
– Scientific Advisory Board, 1999 – 2004.

Corcept
– Scientific Advisory Board, 2001 – 2006

Cyberonics
– Scientific Advisory Board, 2002 – 2006.
– Chair, Mechanism of Action Board, 2003 – 2006.

Cypress Biosciences, Inc.
– Board of Directors, 2001 – 2004
– Consultant, 2004 – 2006

Eli Lilly and Company
– Psychiatry Advisory Board, 1990 – 2000.
– Bipolar Advisory Board, 1998 – 1999.
– Consultant, 2002 – 2003.
– Global Neuroscience Advisory Board, 2005 – 2006.

Forest Laboratories
– Citalopram Clinical Advisory Board, 1997 – 2002.
– Psychiatry Scientific Advisory Board, Chairman, 1999 – 2008.

GlaxoSmithKline Advisory Board of Psychiatrists
– Chairman, 1991 – 2004.

Janssen Pharmaceuticals
– Mood Disorders Advisory Board, Member and Chairman, 1998 – 2004.
– Topiramate Advisory Board, Member and Chairman, 1999 – 2001.
– Antipsychotic Advisory Board, Member, 1999 – present.

Johnson & Johnson Scientific Advisory Board, 2007- present.

Lundbeck
– Consultant, 2006

Merck Sharp & Dohme Research Laboratories
– Consultant, Neuroscience Research Center, 1994.
– Mood Disorders Advisory Board, 1999 – 2003.

Merck-MedCo Mental Health Advisory Board
– Member, 1996 – 1998

Mt. Cook Pharma
– Board of Directors, 2007 – Present

Neurocrine Biosciences
– Scientific Advisory Board, 1994 – 2004.

Neuronetics
– Scientific Advisory Board, 2006

Novadel Pharma
– Board of Directors, 2003 – present
– Chair, Scientific Advisory Committee
– Member, Compensation Committee
– Member, Nominating Committee

Novartis Pharmaceutical Company
– Bipolar Advisory Board Chairman, 2001 – 2003.
– Pediatric Bipolar Advisory Board, 2002 – 2003.
– Antidepressant Advisory Board, 2006.

Organon Pharmaceuticals Psychiatry Advisory Board
– Member, 1997 – 2004.

Otsuka Psychiatry Advisory Board
– Chairman, 2003 – 2006.

PharmaNeuroboost
– Scientific Advisory Board, 2006 – present.

Pfizer Pharmaceuticals
– Clinical Neuroscience Advisory Board, 2004 – 2006.
– Chair, Antipsychotic Advisory Board, 2004 – 2006.

Quintiles Scientific Advisory Board, 2004 – present

Revaax
– Stockholder

Roche Laboratories, a Division of Hoffman-LaRoche, Inc.
– Mania Advisory Board, 1993.
– Pharmocogenomics Advisory Board, 2006

Sanofi/Synthelabo
– Psychiatry Advisory Board, 2002 – 2005.

SciRex
– Scientific Advisory Board, 1999 – 2003.

Solvay Pharmaceuticals Psychiatry Advisory Board
– Member, 1991 – 1999.
– Chairman, 1991 – 1999.
– Antipsychotic Advisory Board, 2005 – 2006.

Somerset Pharmaceuticals Psychiatry Advisory Board
– Chair, 2000 – 2004.

Vela Pharmaceuticals
– Scientific Advisory Board, 2001 – 2002.

Wyeth-Ayerst Psychiatric Advisory Board
– Chairman and Member, 1995 – 2002.