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Healthy Skepticism Library item: 20243

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Case

Phillips & Cohen
Whistleblower ('qui tam') lawsuit against Glaxo
Glaxo Whistleblower Case: Off-label marketing and kickbacks settlement 2012
http://www.glaxowhistleblowers.com/lawsuit/


Abstract:

Phillips & 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.


Full text:

Exhibit 1 – GSK performance – based sales incentive: “The Strongest Link: Special Incentive Program for Wellbutrin SR”
Exhibit 2 – GSK slides providing performance update, market research and 2002 plan of action for Wellbutrin SR
Exhibit 3 – GSK slides: “Perceptions and Definition of Antidepressant Efficacy Among PCPs, January 6, 2000″
Exhibit 4 – GSK slides: “Market Landscape Study: Wellbutrin SR, October 6, 2000″
Exhibit 5 – GSK sales training slides: “Wellbutrin SR® Operation Hustle Meeting,” May 10 – 18, 1999
Exhibit 6 – GSK sales training material: “Insights on Neurotransmitters, August 2000″
Exhibit 7 – GSK sales training material: “Use of Wellbutrin SR® for the Treatment of Anxiety – Related Disorders, February 4, 2002″
Exhibit 8 – GSK sales training material: “Advances in the Treatment of Depression”
Exhibit 9 – GSK sales training material comparing Wellbutrin SR to its “competition”
Exhibit 10 – Newsweek article, “How it all Starts Inside Your Brain,” as distributed to Wellbutrin field sales teams
Exhibit 11 – Slide set: “The Theoretical Role of Dopamine and Norepinephrine in Human Behavior” developed by Dr. Jim Hudziak
Exhibit 12 – GSK sales training material: “Neurotransmitter and Receptor Pharmacology”
Exhibit 13 – GSK slides: “Wellbutrin SR: Strategic Plan, April 27, 2000″
Exhibit 14 – A. Clayton and J. Pradko, “The Prevalence of Sexual Dysfunction Among New – Generation Antidepressants”
Exhibit 15 – R. Phillips and J. Slaughter, “Depression and Sexual Desire” as distributed to GSK Wellbutrin field sales teams
Exhibit 16 – GSK sales training slides: “Responding to Physician Questions about Prevalence of SexualDysfunction”
Exhibit 17 – GSK slides: “2002 Strategy Plan for Wellbutrin SR”
Exhibit 18 – Wellbutrin Faxback: “Effects of Wellbutrin SR® on Body Weight”
Exhibit 19 – Glaxo – funded study: “Bupropion SR in Obesity: A Randomized Double – Blind Placebo – Controlled Study”
Exhibit 20 – GSK memo re: “New Data on Weight” and attachment
Exhibit 21 – “National Speak Training Agenda and Faculty for Wellbutrin SR® December 6 – 7, 2001″
Exhibit 22 – GSK memo re: “New Data on Weight” and attachment
Exhibit 23 – “Wellbutrin XL Clinical Program Outline” revised May 16, 2002
Exhibit 24 – GSK 2003 “Plan of Action” presentation slides showing Wellbutrin’s annual revenue growth
Exhibit 25 – 2003 Wellbutrin “Operating Plan”
Exhibit 26 – Wellbutrin SR Memo re: “P.R.I.D.E 2001 Program Roll – out”
Exhibit 27 – GSK slide: “2003 PRIDE Rationale & Objectives”
Exhibit 28 – “PRIDE Program Schedule – Wellburtrin SR”
Exhibit 29 – “Pradko – Hudziak – Green Program Schedule – Wellbutrin SR”
Exhibit 30 – GSK memo re: “P.R.I.D.E 2002 Teleconferences – May & June”
Exhibit 31 – Email exchange re: “PRIDE Teleconference Slides”
Exhibit 32 – PRIDE Thought Leader Teleconference schedule. February – March 2003
Exhibit 33 – GSK speaker allocations
Exhibit 34 – “Wellbutrin 2003 Teleconference Schedule”
Exhibit 35 – List of GSK’s approved Wellbutrin PRIDE speakers for 2001
Exhibit 36 – GSK memo re: “2003 PRIDE Binder”
Exhibit 37 – PRIDE Binder table of contents
Exhibit 38 – SCS PRIDE program summary
Exhibit 39 – “Wellbutrin SR: Depression Programming” listing product speakers by date
Exhibit 40 – GSK invitation to attend a December 2001 PRIDE event
Exhibit 43 – “Speaker Training Meeting for Wellbutrin SR®” Agenda for January 26 – 28, 2001, showing Dr. Pradko as a speaker
Exhibit 44 – Email conversation re: “Wellbutrin Teleconference & PRIDE Report(s),” May 31, 2002
Exhibit 45 – Outline from GSK speaker Dr. James Pradko’s presentation “Neuroreceptor Basis of Initial Antidepressant Choice”
Exhibit 46 – Slides from GSK speaker Dr. James Pradko’s February 28, 2002 presentation of “Neuroreceptor Basis of Initial Antidepressant Choice”
Exhibit 47 – Slides from GSK speaker Dr. James Pradko’s April 21, 2002 presentation of “Neuroreceptor Basis of Initial Antidepressant Choice”
Exhibit 48 – Slides from GSK speaker Dr. James Pradko’s July 26, 2002 presentation of “Neuroreceptor Basis of Initial Antidepressant Choice”
Exhibit 49 – Slides from GSK speaker Dr. James Pradko’s August 26, 2002 presentation of “Neuroreceptor Basis of Initial Antidepressant Choice”
Exhibit 50 – GSK email exchange re: “Key Points from Dr. Hudziak Program,” August 27, 2002.
Exhibit 51 – Slides from GSK speaker Dr. Jim Hudziak’s presentation “The Theoretical Role of Dopamine and Norepinephrine in Human Behavior”
Exhibit 52 – Slides from GSK speaker Dr. Jim Hudziak’s presentation “The Theoretical role of Serotonin, Norepinephrine and Dopamine in Human Behavior”
Exhibit 53 – Slides from GSK speaker Dr. Jim Hudziak’s presentation “Novel Approaches to the Selection of Antidepressants”
Exhibit 54 – Email exchange re: “Key Points from Dr. Hudziak program”
Exhibit 55 – Outline of GSK speaker Dr. Norman Sussman’s September 20, 2002 PRIDE presentation
Exhibit 56 – Email exchange and summary of a PRIDE event at which GSK speaker Dr. Sarah Atkinson presented
Exhibit 57 – Slides from GSK speaker Dr. Anita Clayton’s presentation “The Impact Antidepressants have on Sexual Function and Weight”
Exhibit 58 – Slides from a presentation titled “Matching the Treatment to the Patient”
Exhibit 59 – GSK email forwarding notes from Dr. Sarah Atkinson’s PRIDE presentation “Mood Disorders in Complex Patients & Overlapping Disorders”
Exhibit 60 – GSK email exchange regarding a PRIDE presentation by Dr. Sarah Atkinson
Exhibit 61 – Slides from GSK speaker Dr. Jeffery Green’s November 1, 2001 presentation “Current Issues in Antidepressant Selection”
Exhibit 62 – Slides from GSK speaker Dr. Jeffery Green’s Ocotber 29, 2002 presentation “Current Issues in Antidepressant Selection”
Exhibit 63 – Slides from GSK speaker Dr. James Pradko’s presentation “Neuroreceptor Basis of Initial Antidepressant Choice” with advertisement for audio recording of lecture
Exhibit 64 – GSK memo re and slides from GSK speaker Dr. James Pradko’s March 5, 2000 presentation of “Neurorecptor Basis of Initial Antidepressant Choice”
Exhibit 65 – “Wonderful Wellbutrin?” article describing Wellbutrin’s sex – enhancing effects, as distributed to Wellbutrin field sales teams
Exhibit 66 – GSK memo re: “New Data on Weight,” June 27, 2001
Exhibit 67 – GSK slides: “Effects of Wellbutrin SR® on Body Weight”
Exhibit 68 – Slides from GSK speaker Dr. Ken Fujoka’s presentation “Effects of Bupropion SR on Body Weight
Exhibit 69 – Slides from a presentation titled “Effects of Wellbutrin SR® (bupropion HCI) Sustained – Release tablets on Body Weight
Exhibit 70 – Kishore M. Gadde, et al., “Bupropion for Weight Loss: An Investigation of Efficacy and Tolerability in Overweight and Obese Women
Exhibit 71 – Adesh K. Jain, et al., “A Study of Bupropion SR compared to Placebo in Obese Adults with Mild to Moderate Depressive Symptoms”
Exhibit 72 – Results from a Glaxo supported study showing “Bupropion SR Significantly Enhances Wight Loss When Used With a Moderate – Intensity Lifestyle Intervention”
Exhibit 73 – Gade KM. Parker CB, Maner LG et al., “Bupropion for Weight Loss: An investigation of Efficacy and tolerability in Overweight and Obese Women”
Exhibit 74 – GSK Faxback titled “Effects of Wellbutrin SR® on Body Weight”
Exhibit 75 – Slides from a presentation titled “Effects of Wellbutrin SR® (bupropion HCI) Sustained – Release Tablets on Body Weight”
Exhibit 76 – GSK slides: “Bupropion SR for Weight Loss: Combination with SlimFast & Exercise”
Exhibit 77 – Slides from a presentation titled “Effects of Wellbutrin SR® on Body Weight”
Exhibit 78 – GSK faxback titled “effects of Wellbutrin SR® on Body Weight,” February 4, 2002
Exhibit 79 – Slides from a presentation titled “Effects of Wellbutrin SR® (bupropion HCI) sustained – Release Tablets on Body Weight”
Exhibit 80 – GSK faxback titled “Effects of Wellbutrin SR® on Body Weight”
Exhibit 81 – Slides from Dr. Adam Keller Ashton’s presentation titled “Decision Making When Managing Antidepressant – Induced Side Effects”
Exhibit 82 – Slides from a presentation: “Effects of Wellbutrin SR® (bupropion HCI) Sustained – Release Tablets on Body Weight
Exhibit 83 – GSK “Knowledge Certification” scenarios including off – label Wellbutrin weight data
Exhibit 84 – GSK Wellbutrin SR® Knowledge Certification evaluation form
Exhibit 85 – Evaluation form for testing GSK sales rep’s knowledge of Wellbutrin’s off – label treatment of ADHD
Exhibit 87 – GSK slides from “2003 Wellbutrin XL Operating Plan”
Exhibit 88 – GSK operating plan – Activity Phasing Overview
Exhibit 89 – GSK training slides: “Verbalization Review for Valtrex®”
Exhibit 90 – GSK marketing slides: “Semester I Managers Meeting POA and Update: Valtrex”
Exhibit 91 – GSK sponsored study: “Tomorrow’s challenges for Herpesvirus Management: Potential Application of Valacyclovir”
Exhibit 92 – GSK training module, “Oral Herpes”
Exhibit 93 – GSK memo re: “Top 25 Honoraria and Grant Recipients”
Exhibit 94 – GSK’s top ten speakers by product
Exhibit 95 – Valtrex “Monthly NRX – Growth Trac”
Exhibit 96 – GSK’s Peer Discussion Budget, November 2002
Exhibit 97 – “Lamictal Neurology National Speaker List”
Exhibit 98 – Advair Product Information as published August 2000
Exhibit 99 – Excerpt from GSK Commercial Practices Policies Resource Manual
Exhibit 100 – Advair “Leader Guide: Elion Workshops – Semester I, ’03″
Exhibit 101 – Avdair Disckus “Selling Resource – Semester I – 2003″
Exhibit 102 – Howard Friedman et al., “A Retrospective Study of the Use of Fluticasone Propinate/Salmeterol Combination as Initial Asthma controller Therapy in a Commercially Insured Population”
Exhibit 103 – Transcript: Glaxo – Wellcome presentation of Advair Diskus to the FDA Pulmonary and Allergy Drugs Advisory Committee on November 23, 1999
Exhibit 104 – Medical Officer Review of Advair dated January 24, 2000
Exhibit 105 – GSK PowerPoint titled “Asthma Semester II, 2002″
Exhibit 106 – GSK PowerPoint titled “Asthma Promotion 2003 Operating Plan”
Exhibit 107 – Advair marketing materials: “Promise Program”
Exhibit 108 – GSK – sponsored “Calhoun study”
Exhibit 109 – GSK – sponsored “Kavuru study”
Exhibit 110 – Advair sales training material: “Advair Selling Resource – Semester II—2003″
Exhibit 111 – Advair sales training material: “Advair Selling Resource – Semester I—2003″
Exhibit 112 – Advair sales training material: “Promotional Cycle II – 2004″
Exhibit 113 – GSK – designed “Fuhlbrigge survey”
Exhibit 114 – GSK slides: “Asthma Promotion 2003 Operating Plan”
Exhibit 115 – Advair marketing materials
Exhibit 116 – NIH guidelines for the diagnosis and management of asthma
Exhibit 117 – HHS/NIH 2007 Summary Report: “Guidelines for the Diagnosis and Management of Asthma”
Exhibit 118 – Advair product information as published in 2003
Exhibit 119 – Advair product information as published in 2006
Exhibit 120 – GSK sales training material: “Steroid Sparing Effects of Serevent®”
Exhibit 121 – A. McIvor et al., “Potential Masking Effects of Salmeterol on Airway Inflammation in Asthma”
Exhibit 123 – GSK letter advising that corticosteroids should not be reduced when salmeterol is initiated
Exhibit 124 – Advair sales training material: “Learning System for Advair Diskus®—Unit 3 – Selling Advair Diskus”
Exhibit 125 – FDA – imposed “Risk Management Plan”
Exhibit 126 – Adviar Diskus® medical officer review (2003)
Exhibit 127 – Flovent Diskus and Advair Diskus 2002 clinical team leader review memorandum (2002)
Exhibit 128 – GSK – sponsored article misrepresenting side effects of Advair 500
Exhibit 129 – GSK – sponsored article misrepresenting side effects of Advair 500
Exhibit 130 – GSK faxback incorporating misleading Advair 500 safety information
Exhibit 131 – GSK faxback incorporating misleading Flovent safety information
Exhibit 132 – GSK CME “Building a COPD Care Plan”
Exhibit 133 – GSK sales training material titled “COPD Market Development Selling Resource – Semster II – 2002″
Exhibit 134 – Adviar Diskus® Medical Officer Review (2003)
Exhibit 135 – GSK “TORCH” study investigating Advair 500 and mortality in COPD patients
Exhibit 136 – GSK Investor Relations slides delivered by Stan Hull in December 2006
Exhibit 137 – GSK Investor Relations slides delivered by Stan Hull in June 2006
Exhibit 138 – GSK Investor Relations slides delivered in February 2007
Exhibit 139 – GSK Investor Relations slides titled “3Q Results 2006″ listing TORCH as a near – term growth opportunity
Exhibit 140 – GSK slides showing Advair 500 sales as the fastest growing of any Advair prescription strength
Exhibit 141 – GSK slides providing “Northeast Regional Overview” of penetration of GSK prescription drugs
Exhibit 142 – Imitrex Injection – product information (2001)
Exhibit 143 – Imitrex Nasal Spray – product information (2001)
Exhibit 144 – Imitrex tablets – product information (2000)
Exhibit 145 – “Migraine Strategic Plan Review – 2000 – 2004″
Exhibit 146 – GSK PowerPoint “Migraine Brand Review” describes “expanding the diagnosis” for migraine care
Exhibit 147 – GSK CNS sales materials
Exhibit 148 – GSK Imitrex sales material using expanded definition of “migraine”
Exhibit 149 – GSK marketing presentation, “One Nerve Network – Multiple Presentations of Migraine,” stating that “Rigid adherence to HIS criteria in diagnosing migraine may result in underdiagnoses of migraine”
Exhibit 150 – Imitrex marketing material listing “migraine myths”
Exhibit 151 – GSK marketing material: “Is it really a tension headache? Take a closer look”
Exhibit 152 – GSK selling resource suggesting that every headache of a migrianeur is a migraine and could be treated with Imitrex
Exhibit 153 – GSK marketing material: “Physician Diagnosed and Patient Self – Described “Sinus Headache” is Predominately Migraine”
Exhibit 154 – GSK promotional publication: “Issues in Headache Management,” February 2003
Exhibit 155 – GSK promotional materials: “Is it really sinus headache? Take a closer look”
Exhibit 156 – GSK promotional materials explaining “Placebo – controlled Study – Migraine patients with self – described ‘sinus headache’”
Exhibit 157 – GSK promotional handout: “A Guide to Understanding Your Migraine”
Exhibit 158 – GSK promotional slides: “Early Intervention with Imitrex® (sumatriptan succinate) in the Treatment of a Migraine Attack”
Exhibit 159 – GSK sales training materials: “Central Nervous System Selling Resource, Semester II – 2001″
Exhibit 160 – GSK documents tracking physician programs and spending in DE County
Exhibit 161 – GSK documents tracking physician programs and spending in Cherry Hill
Exhibit 162 – GSK documents tracking physician programs and spending in Wilmington
Exhibit 163 – GSK sales training slides “New GSK Targeting,” April 2002
Exhibit 164 – Documentation of GSK payments to Dr. Jeffrey Green
Exhibit 165 – Documentation of GSK payments to Dr. Troy Thompson
Exhibit 166 – Documentation of GSK payments to Dr. Troy Thompson
Exhibit 167 – Documentation of GSK payments to Dr. James Pradko
Exhibit 168 – Documentation of GSK payments to Dr. James Pradko
Exhibit 169 – Documentation of GSK payments to Dr. Matthew Pitera
Exhibit 170 – Documentation of GSK payments to Dr. Timothy Smith
Exhibit 171 – Documentation of GSK payments to Dr. James Pradko
Exhibit 172 – Documentation of GSK payments to physician advisory board speakers
Exhibit 173 – Documentation of GSK payments to Dr. James Pradko
Exhibit 174 – Documentation of GSK payments to Dr. Matthew Pitera
Exhibit 175 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 176 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 177 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 178 – Documentation of GSK payments to Dr. James Pradko
Exhibit 179 – Documentation of GSK payments to Dr. James Pradko
Exhibit 180 – Documentation of GSK payments to Dr. James Pradko
Exhibit 181 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 182 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 183 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 184 – Documentation of GSK payments to Dr. Norman Sussman
Exhibit 185 – Documentation of GSK payments to Dr. Jeffrey Green
Exhibit 186 – Documentation of GSK payments to Dr. B. Kenneth Nelson
Exhibit 187 – Documentation of GSK payments to Dr. James Pradko
Exhibit 188 – Documentation of GSK payments to Dr. Jeffrey Green
Exhibit 189 – Documentation of GSK payments to Dr. James Pradko
Exhibit 190 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 191 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 192 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 193 – Documentation of GSK payments to Dr. James Pradko
Exhibit 194 – Documentation of GSK payments to Dr. James Hudziak
Exhibit 195 – GSK Special Issue Boards Schedule
Exhibit 196 – GSK slides evaluating luxury boxes and season tickets expenses
Exhibit 197 – GSK documents tracking physician programs and spending in Harrisburg
Exhibit 198 – GSK documents tracking physician programs and spending in Lancaster
Exhibit 199 – GSK documents tracking physician programs and spending in West Chester
Exhibit 200 – GSK documents tracking physician programs and spending in Camp Hill
Exhibit 201 – Outline from GSK speaker Dr. Sarah Atkinson’s presentation on mood disorders
Exhibit 202 – GSK physician tutorial schedule
Exhibit 203 – GSK documents tracking physician programs and spending in Roxborough
Exhibit 205 – GSK documents tracking physician programs and spending in Lehigh Valley
Exhibit 206 – GSK email exchange Re “Grant Request for Dr. London,” May 9, 2002
Exhibit 207 – GSK email exchange Re “WSR Materials,” May 24, 2002
Exhibit 208 – GSK email exchange Re “Profiles and Depression – CME,” July 16, 2002
Exhibit 209 – GSK slides explaining 2002 Imitrex marketing and speaker programs
Exhibit 210 – Letter confirming James Pradko’s GSK speaking commitments
Exhibit 211 – GSK’s Top Ten speakers by product
Exhibit 212 – GSK email exchange re: “Dr. Sussman’s Buffalo Programs on 9-20-02,” August 7, 2002

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.