GlaxoSmithKline and Thalidomide…


When I first created this blog over 5 years ago, I sub headed it with “Seroxat – The Mental Health Thalidomide. The reason I made a reference to Thalidomide in regards to Seroxat is because I believe that Seroxat is also a defective and dangerous drug, that not only harms those unfortunate enough to be prescribed it but I also suspected that it could damage the unborn. This suspicion has long been verified as an accurate prediction. Seroxat does harm the unborn. But, what I was primarily trying to illustrate by correlating the Seroxat scandal with the Thalidomide scandal was the sheer number of people who have been damaged by this medication. Yes, Thalidomide caused physical defects which are obvious and noticeable, but the damage from Seroxat, as well as being physical, also was highly psychological. The mental scars from Seroxat cannot be seen, but they can be accounted for.

Anyhow, little did I know, GSK were also involved in the Thalidomide scandal…
This from 2011..

http://www.businessweek.com/news/2011-10-27/drugmaker-grunenthal-is-sued-over-thalidomide-birth-defects.html

The thalidomide tragedy is now and always will be a part of Grunenthal’s company history,” according to its website. “Grunenthal and its family shareholders greatly regret the consequences of the thalidomide tragedy.”

Money for Damages

The company said in 2008 that it would pay 50 million euros ($70.9 million) to people injured by the drug.

Smith, Kline & French, now part of Brentford, U.K.-based GlaxoSmithKline, allegedly knew of the defects as early as 1958.

“The allegations in the complaint involve events dating back over 50 years and relate to actions by a predecessor company,” Mary Anne Rhyne, a Research Triangle Park, North Carolina-based spokeswoman for GlaxoSmithKline, said today in an e-mailed statement.

The suit’s allegations are without merit, she said.

“SmithKineFrench never manufactured or sold Thalidomide in the U.S. or elsewhere in the world,” she said. After conducting animal studies and a limited clinical trial, SKF determined the drug was ineffective as a sedative and never sought regulatory approval, Rhyne said.

The case is Yeatts v. SmithKline Beecham Corp., 003316, Pennsylvania Court of Common Pleas, Philadelphia County (Philadelphia).

–Editors: Peter Blumberg, Charles Carter

To contact the reporter on this story: Andrew Harris in Chicago at aharris16@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

Ireland: SSRI’s, The Psychiatric Paradigm and Mental Health


The tide is turning….

http://www.irishexaminer.com/features/debate-on-antidepressants-needed-187775.html

Debate on antidepressants needed

By Ita McSwiney

Wednesday, March 21, 2012

Ita McSwiney outlines some of the concerns surrounding the side-effects of prescribed psychotropic medication

In a personal and human capacity, I would like to add my name to the growing number of people concerned about the side-effects of prescribed psychotropic medication and, in particular, SSRIs, a group of antidepressant medication.

This medication is widely prescribed and its use has almost been normalised in this country in recent years. Data from the General Medical Card Scheme and the Drugs Payment Scheme will attest to the escalating pattern of their use nationally.

I have been working as a nurse in adult mental health services for over 30 years, with the last 12 or more of those as a psychotherapist.

From my experience of my work, I have no doubt that a significant number of people, particularly in the early treatment phase with antidepressants, experience bizarre, and often uncharacteristic thoughts, impulses and images that can be both terrifying and difficult to ignore. Examples disclosed to me in the course of my work that come to mind include:

* A sudden urge to drive across oncoming traffic at speed;

* An impulse to drive their vehicle at speed over unprotected quays, into a wall or over a cliff;

* An urge to physically harm themselves or attack a loved one;

* On one occasion a patient expressed the urge to physically attack me, having spotted a potential weapon near to hand.

While it is difficult to gather scientific data to support this, the website http://www.ssristories.com makes for chilling reading indeed. Data is organised in such a way that this issue can be viewed from a range of perspectives.

And while the information might be more anecdotal than scientific in the strictest sense, the issue cannot be ignored.

Practically all of those referred to me for psychotherapy within the mental health system are already on medication. This would have been prescribed either by their GP (before they were referred to services) or by their psychiatrist within the service.

The only exceptions to this would be those individuals who declined medication in the first place, those who were treated with medication in the past and want an alternative, and those who wish to be supported as they come off medication they are currently prescribed.

There are many forces at play to maintain the usage of medication as the predominant treatment offered to patients in mental health services.

Among these are:

*

The dominance of the medical model of care in mental health services in this country;

* The vested interests of the powerful pharmaceutical industry and its unhealthy co-dependant and exclusive relationship with the profession of psychiatry;

* A cultural expectation that a GP or mental health service provider has a cure or a pill for every pain, and also the resulting dissatisfaction when someone does not get what they want.

The cost of medication is huge, both in human terms and to the exchequer. The latter was brought home to me recently when a friend of mine, new to mental health services herself and not having a Drugs Payment Scheme card, spent €360 on a new prescription over just a three-week period, while awaiting her application for her scheme card to be processed.

I could only imagine the ongoing cost of keeping thousands on medication long-term. And it is almost always long-term. Just because we do not pay the full amount for our prescription does not mean that it is not costing somewhere.
This money would have paid for a lot of therapy and avoided kicking the problem down the road.

However, we cannot blame any one individual or professional group for the design of the current service delivery, where productivity is measured counting throughput, or “bums on seats”.

And with an inadequate psychotherapy service, or even in some locations the absence of any service, it is hard to blame a medic for prescribing something that will take the painful edges off a person’s suffering, albeit for the short-term at least

More highlighting and discussion of this and related issues is urgently needed.

* Ita Mc Swiney is a psychotherapist and supervisor with The Irish Association of Humanistic Psychotherapy

Read more: http://www.irishexaminer.com/features/debate-on-antidepressants-needed-187775.html#ixzz1qAhcywZo

GSK: Corporate manslaughter, fraud, corruption, defective drugs, damaging consumers, breeching ethics, intimidation of critics and general skullduggery… Why do they get away with it?


Perhaps it’s because they have an undue influence within the heart of the UK governmental system?… 

 

 

http://www.independent.co.uk/news/uk/politics/did-osborne-tip-off-glaxosmithkline-about-his-plans-7582611.html

 

Did Osborne tip off GlaxoSmithKline about his plans?

Less than 24 hours after George Osborne confirmed in the Budget that the Government would bring in new tax measures to encourage investment in research and development in the UK, the pharmaceuticals giant GlaxoSmithKline announced it would be building its first new manufacturing facility in the UK for almost 40 years and investing £500m to create 1,000 UK jobs.

Yesterday, Glaxo said its plans had been in the pipeline for some time and pointed out the tax changes had first been mooted back in 2009

.

But others pointed out that Glaxo’s CEO, Sir Andrew Witty, is in David Cameron’s Business Advisory Group – and has regular meetings with the Government. The move, they suggested, was very well choreographed with comments from Sir Andrew, Mr Cameron and Scottish Secretary Michael Moore all approved to go on Glaxo’s press release yesterday morning

Seroxat, Paxil and Other Dirty Glaxo Secrets…


Just thought I would demonstrate to my blog readers the kind of stuff that GSK get up to. All of the following documents have been stored online by POGO, and they are all mainly from GSK litigation trials (Paxil in the US). It really is a remarkable resource for anyone who wishes to gain insight into what goes on in the GSK world. This pharmaceutical company would literally do anything for profit. Some of the documents are quite shocking.

This document is from one of the trials against GSK for fraudulent promotion of Paxil (seroxat). It gives a list of the Doctors whom the drug reps intend to target with gifts, money and enticements.
These psychiatrists and doctors were willingly recruited by GSK in order to make them prescribe Paxil above the competing SSRI’s.

http://dida.library.ucsf.edu/search?query=desc%3Apogo&ct=131&l=1

Produced By GSK In Cunningham v. GSK (U.S.D.C., N.D. Ind.)
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introduction
This booklet is provided to you as a guide to help plan PsychNet programs in your region. PsychNet: Paxil® Clinicians Speaker Council provides trained physician speakers for programs in each region. PsychNet is a new resource for all consultants to use for dinner programs, round tables or any speaker engagement (excluding CME such as CD Rounds: Hidden Diagnosis). PsychNet physicians have ail been educated on the benefits of Paxil® (paroxetine HCI) and its
effective treatment on mood and anxiety disorders.

PsychNet: Paxil® Clinicians Speaker Councils one of many physician programs the Paxilteam has developed for 2000 to engender solid relationships with influential physicians in each region. The goals of the program are to:
o Develop and/or solidify relationships with key influential psychiatrists and primary care physicians
o Develop these physicians into knowledgeable and engaging speakers on Paxil and its effective treatment on mood and anxiety disorders
° Build advocacy amongst PsychNet physicians by creating speaking opportunities
PsychNet is an ideal way for key opinion leaders to influence clinicians in your region on the benefits of Paxil versus competitors.

PsychNet Speakers – Selection and Training
Each region selected several physicians who are influential in their com- munities, credible and interested in speaking on behalf of Paxil. Specifically, the physicians met the following criteria:
o Local key opinion leaders o Educated on the benefits of Paxil o Strong communication skills
A list of regional speakers can be found at the back of this booklet
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Each physician was invited to a weekend training session and educated on the efficacy of Pax/land the PsychNet presentations. The PsychNet Advisory Board reviewed all of the presentations and were closely involved with the training process.
The PsychNet Advisory Board includes: Daniel D. Christensen, MD, Clinical Professor of Psychiatry, Clinical Professor of Neurology Adjunct Professor of Pharmacology, Neuropsychiatry Institute, University of Utah
Prakash S. Masand, MD, Professor of Psychiatry, Director, Psychopharmacology Consultation, Training, and Research Program, SUNY Upstate Medical University
Peter J. Panzarino, MD, Chairman, Department of Psychiatry, Cedars-Sinai Medical Center
David V. Sheehan, MD, MBA, Professor of Psychiatry, University of South Florida College of Medicine, Director, Clinical Research
Guest Speakers at Training Session: CharlesNemeroff,MD,PhD,ReunetteW.HarrisProfessorandChairman, Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine
Rajinder Kumar, MD, Vice President and Director Neurosciences Clinical Research, Development and Medical Affairs of North America, SmithKline Beecham Pharmaceuticals
PsychNet Presentations and Slide Kits
Each PsychNet speaker has been trained on a total of 5 presentations. The PsychNet speaker has been provided with 35 MM slides and CD-ROMs with the following five Power Point presentations:
G Contemporary Issues in Depression – Discusses major depression, SSRI treatment, the efficacy of Paxil in treating depression versus other SSRI/SNRls, and briefly discusses the serotonin/norepinephrine dual action effect of?axil.
• Contemporary Issues in Anxiety Spectrum Disorders – Reviews the prevalence of anxiety spectrum disorders, current treatment options and the efficacy of Paxil to treat anxiety.
* Antidepressants and Managed Care: Issues and Solutions- Discusses the efficacy of Paxil in treating mood and anxiety disorders and the importance of treating these disorders and reviews the cost of treatment ofSSRIs.
3 The Role of Norepinephrine in Depression -A high science presenta- tion that identifies the theory of NET and 5-HT neurotransmitters, reviews the roles of each, and discusses the potential norepinephrine effect of Paxil at higher dosages.
° Controversial Issues in SSRI Therapy: A Critical Review – Highlights the importance of understanding clinical data and looks at issues that affect all SSRIs such as weight gain, sexual dysfunction, drug interac- tion and discontinuation.
PsychNet speaker slide kits also have a Q&A section. This section contains additional data on PTSD, GAD, and PMDD and on special populations (i.e., elderly, adolescent). These should not be incorporated into a promotional Paxil PsychNet talk. The speakers have been informed that in accordance with FDA regulations, these slides are only to be used in response to a specific question during the Q&A period of the talk.
Each of your RMAs and PsychNet Regional Contacts have copies of the slide kit presentations. They will not be available for consultants to order on Powerline.
Compensation and Payment

For every PsychNet presentation, the PsychNet physician will be paid an enhanced honorarium of $2500. If the PsychNet speaker gives more than one presentation in a day, the PsychNet speaker will be paid $1000 for each successive presentation delivered in that day.

Your health care education budget will be charged the customary $750 (the average cost of a physician speaker honorarium) for that physician and the supplemental honorarium of $1750 will be charged against the marketing budget allotted to your region budget for PsychNet. For a secondary $1000 PsychNet presentation, $500 will be charged to your health care education budget and $500 will be charged to the regional PsychNet budget.
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To ensure that your PsychNet physician gets paid properly and in a timely fashion, you must:
• Write “PsychNet Presentation” in the “NOTES” section of your speaker request form and indicate $2500 for the honorarium.
• Send in your Speaker Request form as quickly as possible, no later than 30 days prior to the speaking engagement.
• Work with the physician to ensure that he/she submits his/her expense form as quickly as possible after the speaking engagement.
Management of this process will be quicker and easier once the Regional Meeting Planners have been established.
How PsychNet Works:
• There are a total of 65 PsychNet speakers available to speak at engagements nationwide.
• Each speaker has agreed to do a minimum of 4 and no more than 15 talks per year. A final number of talks depends on scheduling and
SB’s regional need.
• PsychNet speakers have signed a confidentiality agreement to not disclose or share information about the PsychNet program, including compensation and content of materials.
• Speakers will be available to begin speaking engagements after the March 10-12trainingmeeting.
• Each region has a limited number of PsychNet talks that will be managed by the RBA or someone designated by your RVP This person will notify all Paxil consultants in the region if the number of PsychNet talks has been or is close to being completely utilized. (Consult your PsychNet Regional Contact to confirm who will manage the PsychNet budget and number of talks in your region.}
NOTE: Once Regional Meeting Planners (RMPs) have been established and set up in your region, they will be in charge of managing the number of PsychNet talks that are available. It is important to consult with them as they have the information on how many talks the region can support financially.
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The Process: How to Begin
1. The consultant should notify his/her PsychNet Regional Contact that he/she is interested in using a PsychNet speaker and make sure that the region is able to support the PsychNet engagement.
2. The consultant should contact the selected speakers to confirm a date for the presentation.
3. Before the program, the consultant and speaker discuss the objectives of the program and select the appropriate presentation.
4. The consultant should provide the PsychNet Regional Contact with the name of the PsychNet speaker and date of the presentation. Copies of the physician’s Curriculum Vitae and hotel/travel and food preferences will be available for your review from the PsychNet Regional Contact.
NOTE: The Regional Meeting Planners will have this responsibility once they are established for the region.
5. The consultant or RMP will coordinate all travel and accommodations for the speaker, arrange the location and manage the invitation process.
6. After the program, the consultant should provide feedback to the Regional Contact on each program.
Questions and Answers
1. One of my PsychNet doctors also gives Hidden Diagnosis talks. Does he receive a $2500 honorarium for a Hidden Diagnosis talk?
No. PsychNet physicians only receive $2500 for a PsychNet speaking engagement: a promotional Pax/7 talk based on one of the PsychNet presentations. It is against CME regulations for SmithKline Beecham or any pharmaceutical company to enhance the honorarium for any CME-related talk. In addition, it is important to realize that the PsychNet honorarium payment is based on the speaker delivering a promotional Paxil presentation, which CME should not be.
2. Does $2500 include travel and dinner expenses?
No. As with normal speaker engagements, speaker travel and dinner expenses come from your health education and/or field funds.
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3. Do I have to use only the PsychNet speakers from my region or can I use PsychNet speakers in other regions?
You can use PsychNet speakers from any region. Note, however, that each region has a certain number of speaking engagements that they can fund. It is important to keep your PsychNet Regional Contact informed of the speaker you use and how many engagements you set up in your area.
4. Who do I contact if I have questions about the PsychNet program, a speaker or the content of the slide kits?
All of your RMAs will have a PsychNet slide kit available to them. In addition, there is a DSM or RMA PsychNet contact for each region. He/she is available to answer any questions you may have regarding the PsychNet program. See the back of this booklet for your Regional Contact for PsychNet
5. My speaker has already done 9 presentations and he wants to do more, but our region has no more money available to support his honorarium. Can we make an exception?
No. Each region has been allocated a set number of funds for this program that is fixed. We cannot exceed this budget for 2000.
While we strongly encourage the use of PsychNet speakers as many times as possible, you should not feel obligated to offer each
PsychNet physician 15 speaking engagements if that is not necessary for your region. The confidentiality agreement clearly states that only “a minimum of 4 up to 15. The number of presentations will be determined by scheduling and SB’s regional need.”
6. How will the program work when the Regional Meeting Planner is appointed to our region?
In terms of coordination, PsychNet will operate the same way most speaker programs will. Your RMP will coordinate the travel and accommodations for the speaker, send out invitations, and set up the meeting, and disburse payment. In addition, the RMP will monitor the number of PsychNet talks done in the region.
7. Can I order a copy of the slide presentations and distribute them to other speakers that are not a part of the PsychNet Council?
No. PsychNet slide kits are not available at this time for consultant use, nor are we distributing them to physicians not a part of the PsychNet Council. If it is necessary for you to review the presentations, contact your RMA or the PsychNet Regional Contact.
8.1 know a PsychNet physician that could not make the March 10-12 weekend training session. Can I still have him speak?
Yes, but only after he has been trained. All PsychNet physicians that could not make the training meeting will be trained by the Regional Contact at a later date. Please contact your Regional Contact to obtain the date after which the PsychNet speaker will be trained and available to make PsychNet engagements.
9. Why should I use a PsychNet physician rather than any other physician?
There are many advantages for using a PsychNet speaker: • They have been educated on the positive data for Paxil in depression,
social anxiety disorder, OCD and panic disorder.
• Regardless of the cost of a speakers regular honorarium, you pay only $750 from your budget to grant the speaker an enhanced honoraria of$2500.
• You help build Paxil advocacy from the PsychNet key opinion leader. PsychNetls an ideal way for key opinion leaders to influence clinicians
in your region on the benefits of PaxilVersus competitors.
Produced By GSK In Cunningham v. GSK (U.S.D.C., N.D. Ind.)
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Regional Contact List
REGION
New England Shore Region
Northern Lights PA/West Virginia Desert Mountain Mid-America Pacific Sun South Central South West Empire State Pacific Northwest River Valley Florida
South East Blue Ridge
CONTACT
John Cosseboom (DSM)
Lee Drosdak (DSM) Mary Sotirhos (RMA)
Marcelo Ferreyra (DSM) Jim Glavin (RMA) Cindy McKinney (DSM) Sheri Mullen (DSM) Judy Parsons (DSM) Norm H. Rutz (DSM) Karen Schaefer (RMA) Laura Shostak (RMA) Andrew Smith (RMA) Sheldon Thomas (DSM) John Weiner (RMA) Chris Wilkinson (DSM) Sonny Woodruff (DSM)
PHONEMAIU
3128357 3433406
5124783 3341971 1625779 1326845 5427735 1411120 1543107 3243971 5744045 3540814 1127791 3621087 1210239
PAXIL* CLINICIANS SPEAKER COUNCIL
FLORIDA REGION (LA)
Beatriz Currier, MD Department of Psychiatry University of Miami 1611 NW12 Avenue Miami, FL 33125 Phone: 305 585 6115
Joseph Henry, MD 1400 NW 10th Avenue Room 304-A Miami, FL 33136 Phone: 305 243 4060 Fax: 954 437 7654
David Sheehan, MD, MBA 3315 E. Fletcher Avenue University of South Florida College of Medicine Department of Psychiatry 3rd Floor
Tampa, FL 33613 Phone: 813 974 4544 FAX: 813 974 4575
MID-AMERICA REGION (LCI
Emil Coccaro, MD University of Chicago 5841 South Maryland Avenue Chicago, IL 60637 Phone: 773 834 2660
Moises Gaviria, MD 912 Wood Street Chicago, IL 60612 Phone:312996 6139 Fax: 312 9961587
Bennett Leventhal, MD University of Chicago 5841 South Maryland Avenue Chicago, IL 60637 Phone: 773 702 6751
Anatha Shekhar, MD IU Medical Center 550 University Boulevard 3rd Floor Indianapolis, IN 46202
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PAXIL* CLINICIANS SPEAKER COUNCIL
FLORIDA REGION (LA)
Beatriz Currier, MD Department of Psychiatry University of Miami 1611 NW 12 Avenue Miami, FL 33125 Phone: 305 585 6115
Joseph Henry, MD 1400 NW 10th Avenue Room 304-A Miami, FL 33136 Phone: 305 243 4060 Fax: 954 437 7654
David Sheehan, MD, MBA 3315 E.Fletcher Avenue University of South Florida College of Medicine Department of Psychiatry 3rd Floor
Tampa, FL 33613 Phone: 813 974 4544 FAX: 813 974 4575
Michael Ware, MD 2831 NW 41 Street Gainesville, FL 32606 Phone:352 3731332
BLUE RIDGE REGION (LB)
Guy Brannon, MD 1002 Highland Avenue Shreveport,LA71101 Phone: 215 413 7892
Ross Gallow, MD 824 Elmwood Park Suite 135 New Orleans, LA 70123 Phone: 215 413 7892
David L Snow, MD Associate Medical Director Emotional Health & Recovery
Center Blount Memorial Hospital 659 Morganton Square Drive MaryvilleJN 37801 Phone: 865 984 9933 Fax: 865 982 9428
MID-AMERICA REGION (LC) Emil Coccaro, MD
University of Chicago 5841 South Maryland Avenue Chicago, IL 60637 Phone: 773 834 2660
Moises Gaviria, MD 912 Wood Street Chicago, IL 60612 Phone: 312996 6139 Fax: 312 996 1587
Bennett Leventhal, MD University of Chicago 5841 South Maryland Avenue Chicago, IL 60637 Phone: 773 702 6751
Anatha Shekhar, MD IU Medical Center 550 University Boulevard 3rd floor
Indianapolis, IN 46202 Phone: 317 2741246
John Zajecka, MD 1725 Harrison #955 Chicago, IL 60612 Phone: 312 942 4000
SOUTH-CENTRAL REGION (LD)
Dale Anderson, MD 1035 Bellvue Suite 412 St. Louis, MO 63117 Phone: 314 645 1567
Donald Chesler, MD 1000 North Lee Oklahoma City, OK 73101 Phone: 405 272 6716
Ray Clark, MD 5 St. Vincent Circle Suite 301 Little Rock, AR 72205 Phone: 501 666 4266 Fax: 501 666 2149
Jerold J. Kreisman, MD 12255 DePaul Drive Suite 500 Bridgeton, MO 63044 Phone: 314 3447575 Fax: 314 344 7571
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PAXIL* CLINICIANS SPEAKER COUNCIL
H. Mykel Thomas, MD 5701 West 119th, #407 Overland Park, KS 66209 Phone: 913 323 3801
SOUTHWEST REGION (LE)
Stephen Kyle Brannan, MD Department of Psychiatry UTHSCSA 7703 Floyd Curl Drive
San Antonio, TX 78284 Phone: 210 567 5450 Fax: 210 567 6941
Doyle Carson, MD 777 Walter Reed Boulevard Suite 305 Garland, TX 75042 Phone: 972 276 0755 Fax: 972 494 3062
Mary Ann Ty, MD 7324 SW Freeway Suite 610 Houston, TX 77074 Phone: 713 7798963 Fax: 713 777 8963
Jean-Joseph Vanderpool, MD 6151 Dew Drive El Paso, TX 79912 Phone: 915 833 5855
Nishendu Vasavada, MD 560 West Main Suite 101 Lewisville, TX 75057 Phone: 972 2211741
DESERT MOUNTAIN REGION (LF)
Alvin Burstein, MD 2701 Camelback Suite 203 Phoenix, AZ 85016 Phone: 602 957 2368
Robert Davies, MD 4200 East 9th Avenue Denver, CO 80262 Phone: 303 3150452
Steve Methner, MD 501 South Chipeta Way Salt Lake City, UT 84108 Phone: 801 584 2098
Neil Weiner, MD 4770 East lliff Avenue Suite 229 Denver, CO 80222 Phone:303 756 4608
Robert Winski, MD 2033 East Speedway Boulevard Tucson, AZ 85719 Phone: 520 319 3607
NORTHERN UGHTS REGION (MA)
Chalakudy Ramakrishna, MD 15645 Farmington Road Livonia, Ml 48154 Phone: 734 422 4748
Jeffrey Simon, MD 9275 North 49th Street Suite 200 Brown Deer, Wl 53223 Phone: 414 357 9444 Fax: 414 357 9422
ReidTaylor, DO 720 Goldenrod Avenue Holland, Ml 49423 Phone: 616 847 5145 Fax: 616 8421495
Scott Yarosh.MD 2550 University Avenue West Suite 229N St Paul, MN 55114 Phone: 651 6453115 Fax: 651 645 2752
PACIFIC COAST REGION (MC)
Robert Hales, MD 2230 Stockton Boulevard Sacramento, CA 95817 Phone:916734 2980
Allen K. Louie, MD UCSF/Langley Porter
Psychiatric Institute 401 Parnassus Avenue Box F Room 367 San Francisco, CA 95143 Phone: 415 4767017
Michael Resnick, MD 3491 Northwest Raleigh Portland, OR 97210 Phone: 503 784 8539
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Dane Wingerson, MD 325 9th Avenue Box 359896 Seattle, WA 98104 Phone: 206 731 3425
PACIFIC SUN REGION (MD) Vivian Burt, MD
UCLA Neuropsychiatric Institute 760 Westwood Plaza Los Angeles, CA 90024 Phone: 310 206 5135
Amir Kalali, MD Quintiles 10201 Waterridge Circle San Diego, CA 92121 Phone: 858 646 2541
Sidney Zisook, MD Department of Psychiatry 9500 Gilman Drive La Jolla, CA 92093 Phone: 858 534 4040 Fax: 858 552 8585
NEW ENGLAND REGION (RA)
Amjad Bahnassi, MD 198 Russell Street Worcester, MA 01609 Phone: 508 753 5554 Fax: 508 752 7245
Robert J. Birnbaum, MD One Deaconess Road Boston, MA 02115 Phone: 617 632 0100
Michael E. Hirsch, MD Associate Director of
Psychopharmacology Department of Psychiatry One Deaconess Road First Floor Boston, MA 02215 Phone: 617 632 0103 Fax: 617 632 7721
Craig Nelson, MD Professor of Psychiatry Director of Inpatient Services
Yale University School of Medicine
333 Cedar Street New Haven, CT 06520 Phone: 203 688 2157
Mark Pollack, MD 15 Parman Street Boston, MA 02114 Phone: 617 726 3488
EMPIRE STATE REGION (RB)
George Alexpoloulos, MD 22 Bloomingdale Road White Plains, NY 10605 Phone: 914 997 5767
Jeremy Copeland, MD 75-59 263rd Street Glen Oaks, NY 11005 Phone: 718 470 8000

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Manuel B. Montes De Oca, MD 22 Mountainview Avenue Suffern, NY 10901 Phone: 914 368 4384
Robert Weisman, DO 165Q Elmwood Rochester, NY 14620 Phone: 716 275 0300
Richard Wolin, MD 295 Essjay Avenue Williamsville, NY 14221 Phone: 716 630 1204
PENNSYLVANIA/WEST VIRGINIA REGION (RC) M. Khalid Hasan, MD Raleigh Psychiatric Services
24 Mallard Court BeckleyWV 25801 Phone: 304 252 8409 Fax: 304 252 0022
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PAXIL* CLINICIANS SPEAKER COUNCIL
Stuart Levy, DO Friends Hospital 4641 Roosevelt Boulevard Philadelphia, PA 19124 Phone: 215 330 8760 Fax: 215 831 6998
Kenneth B. Nelson, MD Valley Forge Mental Hospital 1033 Germantown Pike Norristown, PA 19401 Phone: 610 539 8500
Rajendra Nigam, MD Western Pennsylvania
PsychCare 150 Pleasant Drive Suite G-5 Aliquippa, PA 15001 Phone: 724 3751050
SHORE REGION (RO)
Martin Buxton, MD 7001 Jahnke Road Richmond, VA 23225 Phone: 804 323 4282
Michael Glasser, MD 9055 Shady Grove Court Gaithersburg, MD 20877 Phone: 301330 0400
Arnold Goldman, MD 401 Kings Highway South Cherry Hill, NJ 08034 Phone: 856 216 0505
Geetha Jayarem, MD 4009 Wildwood Way Ellicott City, MD 21042 Phone: 410461 1058 Fax: 410 4611058
Matthew Pitera, MD Psychiatric Associates Hackensack University Medical
Center 20 Prospect Avenue, Suite 712 Hackensack, New Jersey 07601 Phone: 201488 6543

GSK And The M.H.R.A. : Corrupt bastards?..


Definition of corruption:

“dishonest or fraudulent conduct by those in power”..

corrupt |kəˈrəpt|
adjective
1 having or showing a willingness to act dishonestly in return for money or personal gain : unscrupulous logging companies assisted by corrupt officials.
• evil or morally depraved : the play can do no harm since its audience is already corrupt.
See note at depraved .

Bastard :

2 informal an unpleasant or despicable person : he lied to me, the bastard!
• [with adj. ]

Bob Fiddaman of “Seroxat Sufferers” has some great posts on the ‘revolving door’ syndrome which regularly occurs between pharmaceutical companies and the regulators (whom allegedly are supposed to police them), Bob’s beef (and mine) is about GSK and the MHRA (the UK drug regulators). But you can be damn sure that the same thing happens across the globe in regards to all pharmaceutical companies and all regulators. This is a post from 2010, but it is just as significant to raise these issues today.


http://fiddaman.blogspot.com/2010/06/glaxosmithklinemhra-when-ignorance_07.html

Initially, this was going to be a two-parter, however, more research has led me to another witness for GlaxoSmithKline in the UK Seroxat Group Action – more about him in Part III.

Part IV will show you how another of GSK’s witnesses, they are using for the up and coming UK Seroxat Group Action, works for a company who are in receipt of huge funds from The Wellcome Trust.

Following on from my previous post where I have tried to highlight instances where both GlaxoSmithKline and the MHRA either failed to spot or chose to ignore warnings about Seroxat withdrawal.

I turn my attention now to the UK Seroxat Litigation.

The defining issues of this group action are thus:

Does Seroxat have a capacity to cause adverse effects consequent upon or following discontinuance (withdrawal) such as prevent or make more difficult the ability of users to discontinue, withdrawal from or remain free from taking Seroxat to a greater extent than all other Selective Serotonin Re-uptake Inhibitors (SSRIs)

As I have said, my previous post highlighted the reasons why I think this litigation will be a failure for GlaxoSmithKline. I’m not a lawyer, nor do I work for lawyers. I can, however, determine what is wrong from right.

Before I move on to name one of the ‘expert witnesses’ for GlaxoSmithKline in this litigation I will recap on the evidence I have found just by searching the Internet.

In 1993, the Committee on Safety of Medicines (“CSM”), the UK’s counterpart to the FDA, reported 78 cases of withdrawal after discontinuation of paroxetine, reporting that “such reactions have been reported more often with paroxetine than with other SSRI’s.” (“Current Problems in Pharmacovigilance” (1993; 19:1).

GSK, then SKB, and the MHRA, then the MCA, did not react to this warning.

In 1997, Dr. Haddad reported that the highest incidence of discontinuation reactions among the SSRI’s was paroxetine. (J Clin Psychiatry 1997; 58 Supp l7:17-1; discussion 220.)

In 1997, Young and Currie of Newcastle reported on their survey indicating that a sizeable minority of physicians were aware of the existence of antidepressant withdrawal reactions. This included psychiatrists, 28% of whom expressed no awareness that antidepressant medications could induce discontinuation reactions. The conclusion of the authors was that “education about discontinuation reactions is needed for both psychiatrists and family practice physicians.” (J Clin Psychiatry 1997;58 Suppl &:28-30.)

This particular paper is of interest to me as it was co authored by Allan Young. At the time of the publication [1998] Young was Senior lecturer in psychiatry at Hadrian Clinic, Newcastle General Hospital, Newcastle upon Tyne. The conclusion of Young, along with the other two authors of the publication, Peter Haddad and Michel Lejoyeux, is evident for all to see – “education about discontinuation reactions is needed for both psychiatrists and family practice physicians.”

It is interesting because Allan Young will be one of the expert witnesses on behalf of the defendants, GSK, in the UK Seroxat Group Action. It seems rather odd, to me at least, that GSK would want a witness who has in the past wrote about antidepressant withdrawal reactions.

This is just one of the witnesses for GSK. Another is Dr. Rashmi Shah.

Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd, located in Slough, Berkshire, UK.

Shah’s previous employment history will shock quite a few people who read this article.

Shah was employed by the MHRA between 1987 and 2004. Positions held were:

Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.

An employee of the MHRA for 17 years.

Now a witness for the defence [GSK] in the UK Seroxat Group Action.

Shah retired from the MHRA in 2004.

A summary of the Committee on Safety of Medicines meeting, held on the 25th of November, 2004, attests to this:

1. Apologies and Announcements

1.4 The Chairman informed the Committee that Rashmi Shah’s was retiring and that this was his last meeting and on behalf of the Committee thanked Rashmi for his outstanding contributions to the work of the Committee over a 17 year period and wished him well in his retirement.

I, along with many others, have always been weary of the relationship the regulators have with the pharmaceutical industry so this revelation should come as no surprise.

It would appear that the MHRA’s long standing relationship with GlaxoSmithKline will continue through the High Court in London.

For those of you that don’t know, the MHRA spent four years investigating GlaxoSmithKline.

The investigation focused on whether GSK had failed to inform the agency in a timely manner of information it had on the safety of Seroxat in the under 18’s. The investigation, the largest of its kind in the UK, was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation, and included the scrutiny of over 1 million pages of evidence. The decision taken by Government Prosecutors, based on the investigation findings and legal advice, is that “there is no realistic prospect of a conviction in this case, and that the case should not proceed to criminal prosecution.

The punishment for Glaxo? A “Whose been a naughty boy?” type of letter sent to the then CEO of GSK, JP Garnier. Garnier later went on record to say that GSK had been cleared and that they had done nothing wrong [See audio recording left hand sidebar of this blog]

It’s also worthy to point out that the Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK, then SmithKline Beecham [SKB] – As is the Head of Licensing at the MHRA, Dr. Ian Hudson.

Breckenridge has appeared on national TV defending Seroxat, he has also made his feelings known about Seroxat in various publications, one such being the New Statesman in 2005. Here’s what the Chairman of the MHRA [and ex- SmithKline Beecham employee] had to say about Seroxat:

“If you go back – and I read this out to the Health Select Committee to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.

What Breckenridge ‘read out’ to the Health Select Committee is even more confusing:

“…What the expert working group did was to look at three issues about antidepressants: firstly, the question of withdrawal; secondly, the question of suicidal ideation; and, thirdly, the question of dose. The problem of withdrawal has been well known with antidepressants, especially Seroxat, and I happen to have before me the information sheet, the data sheet which we published, which the MCA published in 1990 when Seroxat was first licensed. If I can just read it to you, it says, ‘As with many psychoactive medicines, it may be advisable to discontinue therapy gradually as abrupt discontinuation may lead to symptoms, such as dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea, sweating and confusion’. That was in 1990″.

There was no mention of this on any patient information leaflet that accompanied Seroxat in 1990. There was no advice to ‘discontinue therapy gradually’ either.

Breckenridge further embarrassed himself and the MHRA with his performance on BBC TV’s Panorama [Taken on Trust BBC TV 2004] where he was reduced to a stuttering wreck by journalist, Shelley Jofre. [A condensed version of his performance can be seen HERE – http://www.youtube.com/watch?v=TozBgI5LyGc

I don’t know why Breckenridge remains at the MHRA, it’s hard to decipher what he actually does. I can only assume that he won’t ever be allowed to appear in front of a TV camera anymore defending Seroxat, not after his display of arrogance back in 2004.

The MHRA’s Head of Licensing, Dr. Ian Hudson, is also a former employee of SmithKline Beecham [now GSK]. Hudson is no stranger to litigation, particularly where GlaxoSmithKline are concerned.

In the Tobin vs SmithKline Beecham trial in 2005, Hudson gave the following deposition http://www.healyprozac.com/Trials/Tobin/Depositions/hudson-depo.txt

Hudson had previously worked for GlaxoSmithKline for 11 years where he held the position of Worldwide Director of Safety.

In a public Declaration of Interests document, Hudson openly admitted that he had a significant involvement with a number of drugs during his time at Glaxo [then SKB] – one of which was Seroxat.
[Source] http://seroxatsecrets.files.wordpress.com/2007/03/dr-ian-hudsons-interests.pdf

Sarah Boseley, then health editor for The Guardian newspaper wrote in 2000, “Alarm as drug company chief joins watchdog.”

A top executive at one of the world’s leading pharmaceutical companies is to become director of drugs licensing at the medicines control agency, raising questions about the independence of the MCA from the industry that it is supposed to police.

Ian Hudson will take up his new job in February. He has worked in the drugs industry for the past 11 years and until recently was director and vice- president of Worldwide Clinical Safety, at SmithKline Beecham, and was to have led the worldwide drug safety group after the merger of SKB with Glaxo Wellcome, which came into effect yesterday.

Boseley also wrote in 2002, “Antidepressant Seroxat tops table of drug withdrawal symptoms.”

Seroxat, the British-made antidepressant which outsells Prozac, causes more people distressing withdrawal problems when they try to stop taking it than any other drug in the UK.

Seroxat – known generically as paroxetine – leads the top 20 table of drugs causing withdrawal problems, with 1,281 complaints from doctors under the “yellow card” scheme set up for the reporting of medicines’ side-effects. More reports have been filed about Seroxat than about the rest of the top 20 put together. In the top six, five of the drugs said to be causing withdrawal problems are SSRIs – second after Seroxat comes Efexor (venlafaxine), with 272 complaints.

So, now, 6 years on from Alasdair Breckenridge’s embarrassing performance on BBC TV where he defended GlaxoSmithKline’s Seroxat and 5 years on from Head of Licensing for the MHRA, Dr. Ian Hudson, offering his services as a witness for GSK, we have yet another MHRA connection in Rashmi Shah.

This shower of regulatory authoritarians [MHRA] have sat with Seroxat advocates, myself included. They have nodded and empathised upon hearing personal stories of withdrawal. All the time, it appears, they knew there was a withdrawal problem with Seroxat but instead of tackling it head on, they decided, like GlaxoSmithKline, to ignore the warning signs from as early as 1993 [Current Problems in Pharmacovigilance] (1993; 19:1).

It’s staggering that they have the audacity to collect their wages each month from their bank accounts.

It’s astounding that they failed to prosecute GlaxoSmithKline after a four year investigation.

It’s appalling that they have not one but two ex-GSK employees working for them, one a Chairman who doesn’t really seem to do much, the other the Head of Licensing, one who grants licenses to the drugs you and I take.

It’s sickening that an ex MHRA employee, in Rashmi Shah, is now defending Seroxat by being a witness for GlaxoSmithKline in the UK Seroxat Group Action.

I cut off all communications with the MHRA last year after they failed to answer a simple question I put to them, Is Seroxat a teratogen?

It would appear that the MHRA have merely been offering token gestures to Seroxat advocates, all the time keeping a close eye on what their paymasters [GSK] might think of them discussing Seroxat with patients.

I’m not the first to pick up on the MHRA’s close ties with GlaxoSmithKline. In 2004, the Daily Mail, a UK tabloid, ran with the headline, “Agency blamed for promoting Seroxat.”

The mental health charity, Mind, said the MHRA were playing Russian Roulette with people’s lives over the common antidepressant drug Seroxat.

Mind chief executive Richard Brook said the MHRA had not listened to the experiences of people who had taken Seroxat.

“Many of these people have suffered terrible side effects when taking or trying to come off the drug and some people, it is believed, have died,” he said.

There is a terrible stench throughout the MHRA Headquarters, it reeks of back slapping and complete and utter disdain for the patient, particularly those who have ever had to experience the horrific side-effects of Seroxat.

The MHRA are not just in bed with GlaxoSmithKline – they are copulating with them.

I am not totally sure but it’s my belief that the expert witness owes a duty to the court to give independent and unbiased evidence, and must avoid assuming the role of advocate for his client.

Rashmi Shah worked for the MCA/MHRA for 17 years. Shah was an employee of the MCA/MHRA when they first granted a licence for GlaxoSmithKline’s Seroxat. He was also employed by them during the time when they received many adverse reaction reports about Seroxat.

I, for one, shall be looking forward to Rashmi Shah’s unbiased evidence when, or if, this group action lands in the High Court later this year.

Coming up in Part III – How another of GSK’s witnesses once called for the FDA to lift its black box warning on antidepressants.

Other stories of interest:

Antidepressant Seroxat tops table of drug withdrawal symptoms

Glaxo ‘played down Seroxat side effects’

Agency blamed for promoting Seroxat

Antidepressant addiction warning

Alarm as drug company chief joins watchdog

DEPENDENCE ON PAROXETINE?

Drug firm issues addiction warning

Keep Seroxat dose low, doctors told

Why I resigned over ‘happy pill’ cover-up

Fid

Paxil (Seroxat) Litigation Court Archive Now Online….


I hadn’t noticed this before, it’s documents relating to various Paxil trials over the years..
Looks interesting..

http://dida.library.ucsf.edu/search?query=desc%3Apogo&ct=1&l=Show+all+fields

    CLICK ON THE LINK ABOVE FOR FULL ACCESS TO THE PAXIL COURT DOCUMENTS

(thanks to Bunker, I just noticed you linked it in a comment, thank you, hadn’t seen it)

Showing 1-10 of 296 documents
1. Minor changes to draft
Document Date: 19990211
Author: Keller, MB
Corporate Author: Brown University
Recipient: Laden, SK
Document Type: letter
Named Person: Brand, B
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par000212926-par000212926
Search Terms in Context: 02-25-99 17:43 SALLY K LADEN STI ID- P . 01 Martin B. Keller, M.D. Mrtry ii. ZurJur hvftam & CJtaumm D^partmwu nf Psyrhiatry ft Unman Behavior BROWN UNIVERSITY Prnvirli-nr*-, Rhode Island 02912 Bmlet Hriiplral Extcuttv* PrjckialriM-irrCknf Emmt Pcn
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Person Copied: McCafferty, JP
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/anu38h10

2. Unipolar adolescent study: proposed titration schedule
Document Date: 19930302
Author: NEAL
Recipient: Birmaher, B; Feinstein, C; Geller, B; Keller, MB; Klein, R; Koplewiss, H; Kutcher, S; Meltzer, B; Small, E; Robbins, D; Strober, M; Williamson, D; Waterman, S; Janosky, S; Ryan, N; McCafferty, JP
Document Type: email
Named Person: Lavori, P; Steinhard, R; Shekim, W
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par000754923-par000754923
Search Terms in Context: TO: Jim McCafferty >4cris Birmaher , VO – 6 ^ V- 3?Oi ^^Cari Feinstein – ¦-• X 1 ^ ¦ ^Barbara Gelier 314 362-6335, •”Marty Keller 401 455-6441, i/Rachei Klein 211 566-6656, ¦¦t^r.ar-z-Ld Kopiewicz “15 470-9291, •Stan Kutcher 416 460-6616, Bruce Meltzer 4C1-435-C515, — ^ileen Small 401-4=5-0516, “tug Robbins 401 436-5149, Ri. ¦i””0l*Li ‘EL’ ‘fOi’Cll 2700; w<^ike Strober 310 206-4446, 7i\7-! 1 1 ' =rr, ;rr <" ¦", t rem: Scott Waterman , Sy 1 vi a Ja no s kv, l/Neai Ryan, Jim McCafferty 215-632-3450 NZAL Organization: WF1C Child Psychobioicgy Date: 3 Feb 93 12:59:59 FST Subject: Unipolar Adolescent Study: F r i o r i ty: n o rrr.a 1 X-mailer: Pegasus Mail v2.3 (R5) . ton siei****** it>iur-?Y*f (AJhjLj> s*rtrr±m (/Kite S7&*c± SfiZ&ty re* v Proposed titration schedule After today’s ;2/3/93) conference phone call it is ver/ clear that reaching consensus on th
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/aou38h10

3. Manuscript 2000/1310
Document Date: 20000215
Author: Dulcan, MK
Corporate Author: Children’s Memorial Hospital
Recipient: Keller, MB
Document Type: letter
Case Number: Steinberg v. GSK (SuperCtCA)
Bates Number: par000757240-par000757240
Search Terms in Context: J tl ‘; l “lit > IS!( … v ,!.’ >\ ;\. 505 Morris Avenue Springfield. New lersev 07081 August 7, 2001 James McCafferty Senior Scientist GlaxoSmithKline 1250 S Collegeville Rd UP4410 PO Box 5089 Collegeville, PA 19426-0980 RE: PAXIL ADOLESCENT DEPRESSION PAPER Dear Jim: I am pleased to enclose a small supply of reprints of the paroxetine-imipramine adolescent depression paper that was recently published in journal of the American Academy of Child and Adolescent Psychiatry. GSK funded the purchase of the reprints. A total of 300 went to Marty Keller, who is corresponding author on the paper, and the balance is being sent to Zach Hawkins for distribution to the Neuroscience sales force. Samples are also being sent to Rocco and Neil. The paper looks excellent and demonstrates the commitment of GSK to the field of psychiatry. Thank you for your support. Sincerely, Sally K. Laden, MS Associate Editorial Director end cc: .1301 PAR001380128 (973) 376-5655 telephon
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/asu38h10

7. US Senate inquiry: removal of Mosholdor from FDA advisory committee meeting and other matters
Document Date: 20040803
Author: Grassley, C
Recipient: Viehbacher, C
Document Type: letter; report
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par004177597-par004177616
Search Terms in Context: 08/03/04 14:18 FAI 215 751 4184 GLA10SMITHKLINE rB6M£iJ^ 59029 .^46Ph chris vichbrcher “** ,’,.,’I’I’.”’¦’•’¦¦> .^ J ‘^——”^^ 1^ 1*1”’ – ¦ ®001 TD:919 315 U2^60 P’VtVS I ¦¦’ I . .TV •• Facsimile Transmittal SQ4 Hart Senate Pffice Building PHONI Fax _Redacted Redacted To: Mr, Christopher Viehbacher Fax: Redacted From: Chairman Chuck Grasaley Date: August 3,2004 Number of pages transmitted, including cover sheet Notes: Pteasft can Tom Novelll an 202224-C447 for problems with transmissions jE Qj^h_clfluki*L JXintMJu \i^i\Uj/}k (Uwcjl fr, < WRING K*7W.VWJ 1MCN7MTT MlMiKBWl T31YM'V»J SNPWI MtfW CIUiaTf4QMAS. WYDMNG uU.HWTnNNMin cg)|ixa* OM
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 20
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/atu38h10

8. Re: Paxil Data request SAEs
Document Date: 20030716
Author: Kline, T
Recipient: Worth, BJ
Document Type: email
Named Person: David, PA; Murray, JF
Named Organization: Food and Drug Administration
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par008184244-par008184247
Search Terms in Context: From: Thomas F Kline/SB-OTHER/PHRD/SB PLC To: Brian J Worth/SB-OTHER/PHRD/SB_PLC@SB_PHARM_RD Subject: Re: Paxil data Request Date: 07/16/2003 13:32:26 (GMT-05:00) I sent the below document to FDA via email on Monday July 14th. I needs to be sent hardcopy to FDA also, so can you prepare a submission accordingly. I'll route a cover letter to you in Cards. Thanks, Tom -— Forwarded by Thomas F Kline/SB-OTHER/PHRD/SB_PLC on 16-Jul-2003 13:30 -— Thomas F Kline 14-Jul-2003 15:20 U.S. Regulatory Affairs – Director, Psychiatry Group One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929 (Mail code: FP 1005) Phone: (215) 751-4054; Fax (215)751-4926; GSK Network: Phone 8-288-4054; email: Thomas_F_Kline@GSK.com To: DAVID@cder.fda.gov cc: RAID@SB Subject: Re: Paxil data Request Paul, In response to the Agency's request, please see the attached document regarding possibly related suicide-related SAEs. The two cases of hostility that were identified
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 4
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/auu38h10

9. Publication date for Paroxetine Depression Study
Document Date: 20010227
Author: Laden, SK
Recipient: McCafferty, JP; Im, J; Battin, MR; Kumar, R; Zaninelli, R; Sproull, SA; Hood, SX; Vitale, SM; Smith, TE
Document Type: email
Named Person: Keller, MB
Case Number: In Re Paxil, C.P.Ct.PA
Bates Number: par008960642-par008960642
Search Terms in Context: From: SallyL@stimedinfo.com To: James P McCafferty/DEV/PHRD/SB_PLC; Johnny lm/FPL/Pharms/SB_PLC; Matt R Battin/FPL/Pharms/SB_PLC; Rajinder Kumar/DEV/PHRD/SB_PLC; Rocco 2 Zaninelli/DEV/PHRD/SB_PLC; Scott A Sproull/FPL/Pharms/SB_PLC; Sheila X Hood/FPL/Pharms/SB_PLC;sherriJaffe@cohnwolfe.com; Steven M Vitale/FPL/Pharms/SB_PLC;tania_lyons@mccann.com; Terri E Smith/FPL/Pharms/SB_PLC CC: File@stimedinfo.com;johnr@stimedinfo.com; MarionP@stimedinfo.com;UnaK@stimedinfo.com Subject: Publication date for Paroxetine Adolescent Depression stud y (PAR 329) Date: 02/27/2001 13:20:56 (GMT-05:00) cc: 1301 Hello Paxil Team: We learned this morning that the Journal of the American Academy of Child and Adolescent Psychiatry has scheduled a tentative publication date for this manuscript. According to their editorial offices, proofs will be available in mid-May with publication scheduled for August, 2001. We have offered to help Dr Keller's office proof the galleys in
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 1
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/avu38h10

10. GSK psychiatry projects: Status report March 2003. Seroxat/Paxil Projects (ghostwrite studies 676, 701)
Document Date: 20030301
Document Type: table
Case Number: Smith v. GSK (SuperCtCA)
Bates Number: par010671035-par010671036
Search Terms in Context: A randomized, 676 Wa JAMA January Agreed 3rd draft – some queries Provide comments on multicenter, double-blind, gne 2003 budget of still outstanding 3rd draft placebo-controlled study r 23,800; to assess the efficacy 15,200 and safety of paroxetine already in children and paid; 8,600 adolescents with social still to be anxiety disorder invoiced [12539] D On track S Some delay I Significant delay Updated: [ TIME @ "d-MMM-yy" ] Page 5 pgNbr=1 GSK PSYCHIATRY PROJECTS : STATUS REPORT [MARCH 2003] SEROXAT/PAXIL PROJECTS Publication title Stud iST Target journal [Project code] y™ aut hor Timeline Paroxetine treatment in 704 Ge\\ J Am Acad Child A January children and adolescents er Adoles Psych 2003 with obsessive-compulsive disorder: a randomized, multicenter, double-blind, placebo-controlled clinical trial
Date Added UCSF: 20110623
Drugs: Paxil; paroxetine
Page Count: 2
Description: Project on Government Oversight (POGO)
Company: GlaxoSmithKline
Bookmark: http://dida.library.ucsf.edu/tid/awu38h10

GSK seeks to span digital divide with social/digital dragnet…


Hmmm..

I wonder, would this new social media driven initiative on behalf of GSK have anything to do with staggering amount of web hits, key word searches and general popularity of blogs such as the “Seroxat Secrets” blog or Bob Fiddaman’s advocacy blog “Seroxat Sufferers” …

Seroxat Secrets just went over the half a million mark (500,000)..

That means it’s been majorly indexed by google web spiders and other web bots for search engines looking for keywords such as ‘Seroxat’ and ‘GSK’…

My own blog receives much of its direct traffic in this way..
It is difficult to counter act this kind of digital web trawling, particularly since blogs such as the ones mentioned, and my own, are firmly established and well connected..

We are webbed, inter-netted, multi-digitally connected, indexed and firmly rooted..

But I have a feeling, that contrary to what the article states.. GSK is doing this more for “web consumer monitoring’ and ‘damage control’ as opposed to authentic engagement with their consumers…

I could be proved wrong..

But I doubt it.. .

For GSK’s latest social media efforts..
See the link:

http://www.mmm-online.com/gsk-seeks-to-span-digital-divide-with-socialdigital-dragnet/article/232700/

GlaxoSmithKline is souping up its social media monitoring with a digital strategy it says will create processes that are standard enough to streamline communications, but flexible enough to meet local requirements.

The company has hired digital agency Fabric Worldwide and IT and consulting firm Infosys to implement their Global Digital Platform. According to the partners, the strategy is one of agility: Infosys says the Global Digital Platform will “allow GSK to quickly build digital assets and listen to consumers across an array of digital platforms.” GSK noted that efficiency is part of the core business strategies the company identified in its 2011 annual report. Meanwhile, WPP techie shop Fabric Worldwide says the partnership will help GSK “consistently understand consumer signals from digital channels, across all brands and all markets.”

However, marketers say it is an attempt at something else: to break out of the industry’s traditional isolation.

“GSK’s decision of taking a more holistic, global, and strategic view of digital is extremely smart and, in my opinion, will yield them a terrific edge in the marketplace,” Fabio Gratton, founder and chief experience officer of Ignite Health told MM&M.

Jim Dayton, senior director of emerging media at the digital marketing agency Intouch Solutions, said he applauds GSK for having the “foresight to have integrated marketing systems that include social monitoring and engagement tools.”

The industry has struggled with balancing the desire to engage consumers without tripping over sketchily-defined regulatory boundaries, but companies can scarcely afford to shun social media altogether.

Gratton added that the move reinforces that digital isn’t about marketing, but about business as a whole, and that the GSK venture deserves credit, regardless of the results.

“Even if they fail, they will be failing forward sooner and faster than anyone else, and that itself is a competitive advantage,” he added.

SSRI Suicide … The ‘Causation’ Conundrum…


causation |kôˈzā sh ən|
noun

the action of causing something : investigating the role of nitrate in the causation of cancer.
• the relationship between cause and effect; causality.

A very close friend of mine is writing her final year thesis on the language that psychiatry uses in order to confuse and obscure the fact that it is an entirely redundant pseudo-belief system which is of no use whatsoever in the treatment of mental health problems. She is writing this thesis through the lens of English critical theory. Critical theory deconstructs and analyses the syntax, terminologies and definitions of words and language. It makes a kind of order out of language. Psychiatry uses language as a weapon and my friend’s thesis aims to examine and explore how it does this. I can’t wait to read her final draft.

One very interesting thing that she intends to scrutinize is this idea of ‘causation’ when it comes to SSRI suicides. Psychiatry and the drug companies claim that there is no way to prove ‘causation’ in a suspected case of SSRI induced suicide . This is indeed quite true, because, if an individual successfully completes a suicide from an SSRI, it is impossible to determine if it was the individual ‘illness’ of mind which led them to successful suicide or the effects of the drug. Depression and other emotional disorders have a risk of suicide, so psychiatry and drug companies can easily manipulate this fact to their favor and they can then dismiss every SSRI suicide down to the individual’s prior mental state.

Basically, to prove causation, an individual would have to kill themselves twice (which is of course entirely impossible). To prove (or to successfully make a claim) that an SSRI causes suicide, an individual would have to firstly kill themselves whilst on an SSRI, then kill themselves again whilst taking an SSRI again. It is because of this conundrum that Psychiatry and the drug companies can easily defend SSRI’s and constantly re-assert that ‘causation’ cannot be determined. When people hear this type of language , ‘causation cannot be determined’, they immediately think in scientific terms, and even the layperson goes along with the jargon, because it sounds convincing to the ear. It sounds plausible because the language employed sounds definitive. But, what it disguises is, the method and theory which could prove causation is mortally and scientifically impossible to enact, therefore what psychiatry should really say is, ‘causation cannot be proven but neither can it be disproven’ because the methodology is scientifically unsound. This would be a far more accurate conclusion. It is all the more sinister when you consider that it is impossible to prove nor disprove ‘causation’ when it comes to SSRI completed suicides. When someone is dead, they can’t come back and complain about side effects can they? It is disturbing when death becomes a way of protecting an ideology. But it seems that psychiatry is quite content in trading and profiting on this gruesome premise.

But there is a way through this…

How about testing SSRI’s on people who are not depressed, not mentally ill and not emotionally disturbed. In other words, how about seeing what their effects are on ‘healthy volunteers’?

Dr David Healy has seen studies that GSK have done with Seroxat on healthy volunteers. These studies are under seal in the Glaxo archives and some of the results are very disturbing. If GSK was an ethical company it would release these studies to the general public, but it seems that it is close to impossible to get access to them. The Seroxat conundrum could easily be solved, but the only way to do that would be through the courts. GSK cannot be allowed to get away with the Seroxat Scandal. Too many people have been damaged, and hurt. This is a human rights issue above and beyond its legal implications. Let’s hope 2012 is the year of Justice. Read on :

http://news.bbc.co.uk/2/hi/programmes/panorama/2317751.stm

As part of my background research for this case, I had been given access to GlaxoSmithKline’s Seroxat healthy volunteer archive. This involved being brought into a room with several hundred thousand pages of data from healthy volunteer trials.

The reason to chase these files was that it had shortly before become clear to me from a study conducted in north Wales on healthy volunteers taking sertraline, another SSRI, and from looking through the healthy volunteer archives held by Pfizer on sertraline, that SSRIs could trigger suicidality in even healthy volunteers.

Access to GlaxoSmithKline’s archive in Harlow had only been granted, as far as I know, essentially a week before my final report in the case was due to be submitted.

Nevertheless, it was possible to find and assess all the records that were present from studies conducted before Seroxat came on the market. Some records were clearly missing and have not been provided since.

Key studies

It was clear from this that Seroxat caused agitation in around 25% of takers, that it made things worse when the dose of the drug was increased and problems cleared up when the drug was stopped only to re-emerge when it was restarted.

According to the usual rules therefore this drug was causing agitation. There had also been a suicide in the program. And Seroxat in one healthy volunteer study was linked with withdrawal effects in around 85% of subjects.

The Tobin case raised questions about how much of a company’s defense in these SSRI cases depended on ghost-written, or company only authored publications, or how often when there was medical testimony it was based on tabulated figures provided to an expert rather than the raw data.

In the course of the proceedings, it was not contested that key studies had been terminated early with their results left unpublished.

Seroxat Secrets Reaches Over Half A Million Web Hits!!!


Simply fantastic news today from the Seroxat Secrets Blog. Over half a million unique web visitors! Brilliant achievement for the author of the blog and also for all those harmed by pharmaceutical drugs and psychiatry! Just last week I noted my blog reaching over 50,000 hits, and Bob Fiddaman’s Blog reaching well over 300,000 hits, that’s almost one million hits between us! Great Stuff guys…

http://seroxatsecrets.wordpress.com/2012/03/13/its-a-marathon-not-a-sprint/#comments

And, I must say I echo the Seroxat Secrets viewpoint when I say that ..

Glaxo must not be allowed to get away with it.

It’s a marathon – not a sprint.
March 13, 2012 — admin
Well, I never… Seroxat Secrets has just passed 500,000 unique visits. That’s half a million hits.

OK, it took a few years to get here, but I hope it’s been worthwhile and that the blog has helped a few people along the way.

My first post was in 2006 and when I started writing I wanted to create an internet resource that would gather together information and links and allow people to make an informed choice about the medication they were taking – or were about to take. I wanted to provide a counterpoint to the lies and spin that pharmaceutical companies turn out under the guise of ‘marketing’.

A few years ago I added a page to Seroxat Secrets, ‘What I believe’ – and it’s still what I believe:

I believe Seroxat is defective and dangerous.
I believe that Glaxo has hidden negative clinical trial data that shows exactly how dangerous a drug it is.
I believe that Seroxat is addictive.
I believe that Seroxat can cause anger, aggression and violence.
I believe that something must be done to help people who suffer terrible problems during withdrawal, as they desperately try to stop taking Seroxat.
I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.
I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.
I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little. Believe me – I know what I’m talking about.

There is just one thing I’d add to this list today:

Glaxo must not be allowed to get away with it.

http://fiddaman.blogspot.com/

Wednesday, March 14, 2012
Seroxat Secrets, Half a Million of Them
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Seroxat Secrets has reached a milestone. The author of the popular blog has just announced that his hits have gone over the half a million mark – that’s great going!

It’s a terrific blog full of useful information about Seroxat, GlaxoSmithKline and the MHRA. The author pulls no punches either, he writes:

A few years ago I added a page to Seroxat Secrets, ‘What I believe’ – and it’s still what I believe:

I believe Seroxat is defective and dangerous.

I believe that Glaxo has hidden negative clinical trial data that shows exactly how dangerous a drug it is.

I believe that Seroxat is addictive.

I believe that Seroxat can cause anger, aggression and violence.

I believe that something must be done to help people who suffer terrible problems during withdrawal, as they desperately try to stop taking Seroxat.

I believe that doctors have taken large sums of money from Glaxo to lie about the efficacy and safety of the drug.

I believe that GlaxoSmithKline puts profits before patients – their wealth before our health.

I took Seroxat for 9 years and it took me 22 months to withdraw from the drug little by little.

Believe me – I know what I’m talking about.

There is just one thing I’d add to this list today:

Glaxo must not be allowed to get away with it.

I met the author of Seroxat Secrets in London a couple of years ago. I hope to meet him again someday soon. The drinks are on me sir.

Seroxat Secrets is a wealth of information and can be viewed HERE

Fid