Saturday 6 October 2012

Whistleblower (“qui tam”) lawsuit against Glaxo


Phillips and Cohen filed the qui tam lawsuit on behalf of Tom Gerahty and Matthew Burke in federal district court in Boston in 2003.

See United States et al. ex rel. Gerahty, et al. v. GSK et al.,Civ. No. 03-10641 (D. Mass.)

Index of exhibits submitted as part of the whistleblower lawsuit can be found HERE


Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman. Global outlets HERE 



Sunday 10 April 2011

NEW PAXIL BOOK NOW ON SALE

My new book, 'The Evidence, However, Is Clear...The Seroxat Scandal' is now available as a paperback directly from the Chipmunka Publishing website. Copies can be ordered HERE

Price of the book is £10 - Postage from Chipmunka will be £2

The book will be available on Amazon in due course, unsure what the postage will be on Amazon.

Those who have expressed wishes to have the book signed can purchase directly from this blog. Please email me for details at fiddaman64@blueyonder.co.uk

If ordering direct from this blog, the postage to UK will be approx £2. For those overseas, I'll update on postage prices soon.

The Foreword is by Dr Jon Jureidini, child psychiatrist and clinical Professor, Discipline of Psychiatry, University of Adelaide, South Australia.

I owe Jon a great debt as it was he who set up the whole editing process [from Kindle version to paperback]

Here's his foreword.

Bob Fiddaman’s account of his interaction with the Medicines and Health Care Products Regulatory Agency (MHRA) over the antidepressant Seroxat (and of his blogging of that interaction) is comic and tragic in equal measures.

Charles Medawar, whose Antidepressant Web was godparent to Fiddaman’s blog, spoke of a ‘conspiracy of goodwill’ arising out of the wish of all parties (doctors, funders, manufacturers and users) that antidepressants be safe and effective. Fiddaman shows us that there is also ‘bad will’ in this case, identifying cynical and exploitative behaviour by those who we should be able to trust.

Around half of serious adverse affects of drugs are not identified until the medication has been used for a considerable time. This delay is understandable because research to bring a drug onto the market only involves hundreds or thousands of patients, whereas a successfully marketed drug will be taken by millions. Therefore rarer adverse effects sometimes do not become apparent for several years after a medication becomes widely available. By this time many may have been adversely affected by the drug without they or their doctors recognising that it is harmful. And when a drug is very widely prescribed (millions were taking Seroxat), every delay of a day in discovering harms means that thousands more people will suffer. Therefore pharmacovigilance (the detection and analysis of adverse effects of medications once they come into widespread use) has to be central to drug development and research if we are to reduce harm from medication.

But in spite of the fact that pharmaceutical companies have an obligation to monitor adverse effects of their drugs, they invest only a trivial sum in pharmacovigilance. Their priority is the much more profitable enterprise of developing and especially marketing new drugs, where they make huge investment. This imbalance is understandable (though not acceptable) in the light of their need to turn a profit, and reflects the lack of any significant disciplining of their activities by regulatory bodies.

One person’s reported experience with a drug proves little but Fiddaman shows us what we can learn when we collect together the experience of many users. Patients’ collective experiences with their drugs constitute a gold mine of information for the health system and pharmaceutical industry, but we doctors and scientist make barely any effort to collect the data and make sense of it. It is left to small heroes like Bob Fiddaman to irritate the system. A more rigorous and informative examination of patients’ experiences with drugs could prevent countless crippling adverse events. If we do ever achieve a truly effective system of pharmacovigilance, then Bob Fiddaman’s blog will have played an important part in this outcome.



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Thursday 24 September 2009

KILKER v GLAXOSMITHKLINE COURT DOCUMENTS

All documents to the Kilker v GlaxoSmithKline trial have now been uploaded to the Tracey Law Firm website

The documents are thus:

COURT TRANSCRIPTS
**Some links may not be working

9/15/09 AM: Opening Statements
9/15/09 PM: David Healy, M.D. -- Direct Examination
9/16/09 AM: David Healy, M.D. -- Direct (continued)
9/17/09 AM: David Healy, M.D. -- Cross Examination
9/17/09 PM: David Healy, M.D. -- Recross; Redirect
9/18/09 AM: Suzanne Parisian, M.D. -- Direct Examination
9/18/09 PM: Suzanne Parisian, M.D. -- Direct (continued)
9/22/09 AM: Suzanne Parisian, M.D. -- Cross Examination
9/22/09 PM: Suzanne Parisian, M.D. -- Redirect; Recross
9/21/09 AM: Shira Kramer, Ph.D. -- Direct Examination
9/21/09 PM: Shira Kramer, Ph.D. -- Direct (continued); Cross Examination; Redirect
9/23/09 AM: Ra-id Abdulla, M.D. -- Direct Examination
9/23/09 PM: Ra-id Abdulla, M.D. -- Cross Examination; Redirect
9/29/09 AM: Anthony Scialli, M.D. -- Direct Examination
9/29/09 PM: Anthony Scialli, M.D. -- Cross Examination
9/30/09 AM: Anthony Scialli, M.D. -- Redirect; Recross
9/30/09 AM: Stephen Hobbiger, BSC -- Direct Examination
9/30/09 PM: Stephen Hobbiger, BSC -- Cross Examination; Redirect
10/1/09 AM: H. Scott Baldwin, M.D. -- Direct Examination
10/1/09 PM: H. Scott Baldwin, M.D. -- Cross; Redirect; Recross
10/2/09 AM: Judith Jones, M.D., PhD -- Direct Examination
10/2/09 AM: Judith Jones, M.D., PhD -- Cross Exaination; Redirect
10/6/09 AM: Gary Shaw, PhD -- Direct Examination
10/6/09 PM: Gary Shaw, PhD -- Cross Examination; Redirect
10/8/09 AM: Closing Arguments -- Plaintiff & Defendant
10/8/09 PM: Closing Arguments -- Plaintiff Rebuttle & Jury Charge


Plaintiff's Experts:

Ra-id Abdulla, M.D., Pediatric Cardiologist, Professor of Pediatrics, Rush University in Chicago

David Healy, M.D., FRCPsych, Neuropyschopharmacologist, Professor of Psychiatry, Cardiff University,University Hospital Wales North Wales Department of Psychological Medicine

Valerie Parisi, RN, Lifecare Planner

Suzanne Parisian, M.D., former FDA employee

Shira Kramer, Ph.D., Epidemiologist




Defendant's Experts:

H. Scott Baldwin, M.D., Pediatric Cardiologist, Children's Hospital at Vanderbilt

Stephen Hobbiger, BSC, Vice President of Neuroscience, Global Clinical Safety & Pharmaco Vigilance

Judit Jones, M.D., Ph.D., FDA expert, Clinical Pharmacologist, Pharmacoepidemiologist

Anthony Sciali, M.D., OB/GYN, Reproductive Toxicologist, George Washington University

Gary Shaw, Ph.D., Epidemiologist

**An edited version of Jane Nieman's [Glaxo Ex-Executive] Testimony can be downloaded HERE

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SEROXAT SUFFERERS STAND UP AND BE COUNTED



JULY 2009 SSRI WITHDRAWAL GUIDE BY DAVID HEALY


Friday 17 April 2009

GSK FILES

Special Thanks to Christopher Lane and Doug Bremner


PAXIL/SEROXAT - GREATEST NUMBER OF SUICIDE ATTEMPTS**NEW





**NEW
GSK Paxil Caspper Document







GlaxoSmithKline program called “Psychnet”



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Foreword by Paul N. Jenner, Director and Vice President of Neuroscience and Strategic Product Development



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Section 1: Towards the Second Billion -- All SSRIs Are Not the Same



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Section 2: New Indications: Social Anxiety Disorder / Social Phobia



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Section 3: Issues Management: Managing the Discontinuation Issue.



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"Duration of Treatment and Depression: Relapse and Recurrence Rates"



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"Paxil CR" Product Monograph



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Paxil Litigation Documents



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GSK's paxil.com... still a wealth of [dis]information






OTHER FILES/ARTICLES OF IMPORTANCE

MENATL HEALTH ADVOCATES ATTACK SEROXAT CAMPAIGNERS, LITIGANTS AND SOLICITORS




GIRLS USED AS GUINEA PIGS IN HPV TRIALS ADMITS GSK



DOCUMENT RETENTION, LETTERS TO MINISTERS, LETTERS AND EMAILS ABOUT SEROXAT AND LIST OF FOI REQUESTS



MINUTES OF MEETING BETWEEN MHRA AND BOB FIDDAMAN



PRESS RELEASE: GSK INVESTIGATION CONCLUDES



MHRA INVESTIGATION INTO GLAXOSMITHKLINE/SEROXAT



GSK SEROXAT - LETTER TO GSK FROM MHRA



GSK SEROXAT - LETTER TO TRADE ASSOCIATIONS



SUMMARY OF REGULATORY ACTION



LETTER FROM GSK CHIEF MEDICAL OFFICER TO MHRA



MHRA RESPONSE TO LETTER FROM GSK CHIEF MEDICAL OFFICER



MHRA CRITISIZED



WHO KILLED JAPANESE CULTURE?
Article By Bob Fiddaman




PAXIL STUDY 329 ALL OVER AGAIN?
Article By Bob Fiddaman




SSRi Antidepressant Drugs
Jeffrey Dach






More Seroxat related articles at http://fiddaman.blogspot.com