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The Truth

About the Drug Companies 20

500 359
337


911

14%
31%

1998
2002 FDA 415 58

[]

2 000 12%
1999 18%

Schering-Plough Claritin
5 13 50% 4

2002 50 1 500

1965

2003
2006

2001

1 500
6
9 000

HMO
Department of Veterans Affairs


R&D
20
2003

NIH

Mevacor Lipitor Zocor Pravachol Lescol Crestor


Kaiser Permanente Medical Group
Sharon Levine

20
Prozac Prozac

FDA

2002
PfizerMerckJohnson & Johnson
Bristol-Myers SquibbWyeth American Home Products

GlaxoSmithKlineAstraZenecaNovartis
Roche Aventis2004 Aventis
Sanofi-Synthelabo

NIH

Academic Medical Center

20

Debbie Stabenow

FDA

2000

1980
1960 1980
1980 2000
2 000 1980
2003 500 47

2001

2002 2003

2 000
2002

25%

IMS Health
2002 4 000
2 000 4 000

1980 Ronald Reagan

20 90

1980

Bayh-Dole Act[Birch BayhD-Ind.]

[Robert DoleR-Kans.]

NIH

1984 Hatch-Waxman Act

20%

brand
druggeneric drug

USPTO FDA

Orrin HatchR-UtahHenry Waxman


D-Calif. FDA

20 90

1980 8 2000 14
10 Lipitor Celebrex
Zoloft 6

20
1990 FDA


1990 25%
90
2001
500

18.5% 500
3.3%
13.5%

2002
18.5% 17%2002 500
359 490 337
2003 500 14.3%
4.6%

1990 11% 2000 14%

1990 36%
2.5

SEC

Families USA
Charles A. Heimbold Jr.2001 7 400
7 600 Wyeth 4 052
4 063

GlaxoSmithKline

AstraZeneca Novartis Roche Aventis

PhRMANotartis
Daniel Vasella

MIT

1980 2000
20 90

2003

100 200
1987

350

2001 Eli LillyProzac


AstraZeneca Prilosec
60
Glucophage

2002 Claritin

Clarinex

2002 FDA 78 17 7
FDA 71
787 7

2000

FDA

Health and Human Services HHS

2003
[Dan BurtonR-Ind.]

360 60

TAP Lupron
8 7 5

2003
2006

NIH

preclinical


the Achillles heel

DNA

PhRMA

AZT

AZT
ZidovudineRetrovir
Burroughs WellcomeGlaxoSmithKline
AZT
Burroughs Wellcome

1981

Pasteur Institute
retrovirus

1964 AZT
AZT 1974
Burroughs Wellcome

1983
Samuel Broder

Burroughs Wellcome AZT1985 Duke University


AZT Burroughs Wellcome
1987 FDA

1
Broder
Burroughs Wellcome

AZT

AZT Burroughs Wellcome

FDA
FDA

FDA

20

Contract Research Organizations

2001 1 000 70

2001 8
230
FDA

FDA

FDA

10%

FDA

2001
7 000 2000

12 000
30 000

30 000

FDA

FDA
FDA

FDA 18

FDA 1984

branded generics

FDA

2001
30 34 000 FDA

FDA 1906 Food and Drug Act

Upton Sinclair1906 The Jungle


FDA 9 000

95 000

1938
FDA
1951
1962

FDA

The Wall
Street JournalWashington Legal Foundation
FDA

FDA

FDA


FDA 2002
16

FDA

FDA

1906
caveat
emptorme-too
me-too

2001 8 2
Bain & Company 17

Alan F. Holmer

William Safire

8 2
SEC
PhRMA

2000
260 98
2 6 5 1 7 5
34%
PhRMA
2001
300 66
4 5 5 3

Public Citizen
1994 2000

1
PhRMA 20 90
1
8 2

8 2
Tufts Center for the Study of Drug

DevelopmentJoseph DiMasi 2001 11 30

Kenneth I. Kaitlin

1987 8 2

68

8 2

FDA
2002 78
FDA
new molecular entitiesNMEs2002
78 17 NMEs


NCEs
NMEs

75%

8 2

8 2

68

4 3 8 2


4 3
8 2



20 50%1983
2000 FDA 231

20

Internal Revenue
Service

1993
1996 16.2% 27.3%

34%
4 3 2
6 6

1
8 2

8 2

MerckRay Gilmartin


2001 300

PhRMA
300

2002 500 2 710


14% 310 17% 360

31% 670

2001
5 2

Enron

50%

Alan Sager
1 000
1 400

Merck
8 2

5 10

FDA
http//www.fda.gov/cder/rdmt/patable.htm
FDA FDA

NME

FDA

P.S
FDA

1998 2002
415
83 133 32% 133
58 12
14%2001 2002 7
2000 9 1999
19 1998 16

14
35
2001 7

5 2 Novartis

Merck
Allergan Gilead Sciences
Gleevec
Zometa
Cancidas
LumiganGilead
Viread AZT

2002 7
ZelnormNovartisEloxatin
sanofi-Synthelabo
HepseraGilead Sciences B

Gleevec

300

90%

1980
Stevenson-Wydler Act

AZT

Bob Ingram

17% 30%
35%Bob Ingram

Taxol

Taxol
paclitaxel
20 60

30 1 8 3 1991

1986 Federal Technology Transfer Act


17 paclitaxel
1992
Taxol FDA 5

1994

Taxol

Taxol
10~20
FDA

Taxol

Epogen

Epogen
Epogen

Erythropoietin 1976 Eugene Goldwasser

Amgen
Amgen
Epogen 20
Taxol Epogen

Epogen Procrit Johnson & Johnson


Amgen

Amgen
Epogen Amgen
Epogen
Amgen
Ortho Procrit Procrit 30
Amgen Amgen Epogen 1%
Amgen
Aranesp Procrit

Taxol
Erythropoietin Amgen
Amgen Erythropoietin
Amgen
Amgen

Gleevec

GleevecImatinib Mesylate

2001 7 Gleevec

Gleevec

Gleevec

1960

1994

Brian J.
DrukerNicholas
Lydon

1999

FDA
Gleevec

Health Affairs
1998 15% 54%
13%

2000 2
1995
5 Zantac Zovirax Capoten Vasotec Prozac
17 16 Prozac
15%55%
30%

the National Bureau of Economic Research1997


1965 1992 21 14

Boston Globe1992 1997 50 45

Merrill Goozner8
The $800 Million Pill

Taxol Gleevec

Taxol 1 2
20

Taxol
2003 3 5
90
0.5%

Gleevec 2 7
Gleevec
Gleevec
Gleevec

2003

Cerezyme Genzyme
Gauchers
Disease 5 000

[Roscoe Brady
] 20 30
8

Genzyme

Roche Fuzeon 2003


FDA
Vanessa FuhrmansFuzeon

2
Fuzeon

13 Fuzeon

1995
Taxol

1995
1989

2001 Ron WydenD-Ore.


47 4 TaxolEpogenProcrit
Neupogen
43

47 4

Epogen 17
30 3 20 70

FDA

FDA Robert Temple

1998 2002 FDA 415


14% 9% FDA
77%

77%

FDA

Nexium Nexium AstraZeneca


2001
Prilosec Prilosec
Prilosec
60


Prilosec
Omeprazole Prilosec
NexiumPrilosec

Prilosec Prilosec

Prilosec FDA Nexium


Prilosec Nexium
Nexium Nexium
Nexium Prilosec

Nexium Prilosec
2001 5
Nexium Prilosec
Nexium Prilosec
Prolisec Nexium

FDA Nexium
Nexium Nexium Prilosec
Nexium
Prilosec

20mg 10mg
Nexium 20mg Prolisec Nexium
20mg 40mg Nexium 20mg Prolisec Nexium

Nexium Nexium
Prilosec

Nexium
4
Tom Scully
Nexium

Clarinex Claritin
Claritin 2002 2001
Claritin 27 1987
Claritin Claritin
Claritin 2001 FDA Clarinex Claritin
Claritin
ClarinexClarinex ClaritinClarinex
Clarinex
Claritin
Claritin
Clarinex

Prilosec Nexium
Claritin Clarinex

Statins
2003 FDA Crestor
Mevacor1987

Mevacor
Zocor Lipitor Pravachol Lescol

CrestorBayer Baycol

Statins

FDA

Lipitor Pravachol 1998


80mg Lipitor 40mg Pravachol
Pravachol 80mg Lipitor Pravachol
Crestor
FDA

Crestor
Baycol

Mevacor Lovastatin
Lipitor Zocor 2002

Prilosec Mevacor

Prozac 5-
Selective Serotonin Reuptake Inhibitors
1987 FDA Prozac 1994

1996 1999
Prozac 26

5- Paxil 1997 Zoloft


1999 5- Celexa
LexaproProzac 2001 8
Fluoxetine 80%
Paxil Zoloft Prilosec Mevacor
Prozac

5-
Prozac Prilosec Nexium
Claritin Clarinex Prozac Sarafem
FDA Premenstrual Dysphoric Disorder
Prozac 3.5

Gleevec
Gleevec

20

140/90mmHg

120/80 140/90

1dL
280mg 240mg 200mg

Lipitor 2002
Zocor

Growth
Hormone


2002 Prilosec Nexium
Prevacid

Sarafem PMDD

Sarafem Prozac
Zoloft 5-

Viagra Levitra Cialis

FDA

Clarinex Claritin
FDA

5-SSRIs
Prozac

Paxil


Carl Elliott
Paxil

Paxil Barry
Brand

Paxil Generalized Anxiety Disorder2001


911

Maureen Dowd

Lipitor Zocor

Prilosec Nexium

7
ACEFDA
Robert Temple

FDA

Mark Goldberger

2001

2000
CDC
Booster
2002

4 20 4

1994

American Home Products

FDA

FDA

Crestor Lexapro Cialis

FDA

FDA

ALLHAT

ALLHAT
600 42 000
1 Norvasc
2002 2Alpha-Adrenergic
Blocker Cardura Doxazosin
3
ACEI Zestril Prinivil
Lisinopril4 50

2002 The Journal of the American Medical


Association

Norvasc
Cardura

Cardura
ALLHAT

1996 Norvasc
1982 56%
27%
2001 50 Norvasc
50 ALLHAT

2002 37
Norvasc 715 230
Norvasc 19
2 4
ALLHAT
ALLHAT
Curt Furberg

ALLHAT

ALLHAT

ALLHAT 1994 7
100

Prinivil Prinivil ALLHAT

20 80

1980

1990 80%
40%

1980

Dana-Farber

Massachusetts General Hospital


1 8
12
Partners HealthCare
Millennium Pharmaceuticals

2003~2004

20

1998 50

2003 David Willman

1995 Harold Varmus

NIDDK

2003 17.9 11
140 86.5

Willman

2003 2259 94%

2004 1

Blue-Ribbon Panel

Norvasc 70
96% 37%

ALLHAT

NSAIDs
Naprosyn
NSAIDs

B
B

Celebrex
PharmaciaCelebrex

Celebrex

1996 Immune Response Corporation


James O. Kahn
Stephen W. Lagakos Remune
FDA
77 2 500

Remune

5% 10%

FDA
FDA

FDA

2002 5-
SSRIsZoloft Paxil SSRIs

FDA1987 1999 ProzacPaxilZoloft


CelexaSerzone Effexor SSRIs
42
6

80%
Hamilton Depression Scale
62
2

SSRIs

Gleevec Epogen Taxol Prilosec


ACE

2001
110

88 000

55 55 88 000
62 500

LevitraViagra
2
Levitra
Gillette StadiumMike Ditka
30 2004 Super Bowl

Bob
DoleRafael Palmeiro
Cialis

60 Morley
Safer
WJMK
6
WJMK
Walter
CronkiteAaron Brown
WJMK

Lauren Bacall
Matt Lauer
Visudyne

2001 Prilosec
Nexium 5

KSMQ

2001
35%

2002
31%

2001 36%
5%
5%

2000 35%12%
2001 35%
5% 30%
1 790
90 540

2001 35%

1DTC
2
34

2001 191
27 55 105
3 8
303

GAO
2002

191

540
1 790 30% 191
350

DTC
1%


1997 FDA
30

1997 FDA

1997 2001
25% 64%

Paxil Zoloft
Celexa

2001 30
34 000

FDA

FDA

Lipitor 4
4

Katharine Greider
The Big Fix
88 000
5~6

Azucena Sanchez-Scott

Washington Redskins

2000 AMA 2002


2002

HMOs
Nexium

Nexium

TAP Lupron

Lupron 65
80%

20 90 Lupron
Zoladex LupronTAP
500 350 500


Lupron

TAP 1996
Tufts Health Plan Lupron
25 000
Joseph Gerstein
Gerstein
65 000

TAP

False Claims Act TAPTAP


8 7 5 11 TAP
TAP

TAP
Lupron Zoladex
3 5 5

TAP AMA
100

30%


2001 30% 35%

Gleevec
Gleevec
Gleevec

NexiumLipitor Paxil

2001 191
350

Zoloft
Paxil

2001 190
350

Clarinex

350

FDA

FDA

TAP TAP

2003

CME

[Accreditation
Council of Continuing Medical Education ACCME]

2001 60%

MECCs
ACCME

ACCME
ACCME
ACCME

2000 30

50

12

American College of Cardiology


American Society of Hematology

10 000

APAIvonne Munez Velazquez

Prozac Paxil
Depakote
Risperdo CD
Celexa

Remeron

30 18

50 20 40
60

3 000 540

Stephen Goldfinger

2002
Code on Interactions with

Healthcare Professionals

A 300

A 15 A

2003

2002

800 24

2003

Kelly Peterson

Hepatitis C
4
Rebetron Rebetron
18 000

Thomas Murray

Effexor
90

MTV Cara Kahn Effexor2002


Alex Beam

120
Effexor

25

FDA
Taxol Taxol

FDA

Neurontin

Parke-Davis Neurontin
Warner-Lambert
2000 1996
David P. Franklin

Neurontin

47 2002

Neurontin 1994 FDA

FDA
1998 2000
Neurontin

Neurontin
12 12 000 1 000

Neurontin

Neurontin

Neurontin

Neurontin 70%

Neurontin 2003 27

80%
Neurontin
2004 5
8 4 3
2 700
Neurontin 27

FDA
2002

FDA Taxol

FDA

10


FDA

FDA
2000

2003
FDA Thomas Fleming

FDA

FDA
Neurontin

CenterWatch

Salix
Colazal
Salix 500

Colazal

Colazal

CROs

FDA

Madison
AvenueOmniconWPP Interpublic

Omnicon SCIREX

Omnicon Proworx Neurontin

WPP Intramed
Intramed
WPP

Xigris2001 Xigris
FDA Xigris 25%
31%FDA

Xigris 6 800 Prozac

2002 Xigris

Belsito & Co. Xigris

Xigris
180
Mitchell Levy Xigris
20
www.vericc.org

Xigris
Xigris 3 400


Xigris

Xigris

FDA

FDA

29%
Glucophage
22%
14%

Glucophage

5 10

50 18
16 000
Neurontin
Clonazepam Lexapro
Trileptal Elavil

Neurontin

USPTO FDA

FDA

20%

10

FDA Roger L. Williams


10 20 Hemant K. Shah

1980

1980
1982

Prozac

FDA


FDA
FDA
20

FDA FDA
FDA

FDA

1980 17 20

1984 Drug Price Competition and


Patent Term Restoration Act
Hatch-Waxman Act

FDA
FDA

20% 50%
10%

FDA

FDA 30
FDA
30

FDA
FDA
45 30
30
6

30

FDA
30

FDA
Neurontin

30

30

1994
17 20 1997 FDA
6
FDA

3
30
6

FDA

PrilosecClaritin Prozac


NexiumPrilosec FDA 3
ClarinexClaritin 5
Sarafem Prozac 3
Prozac

Prilosec

Prilosec 60
Prilosec
1989 FDA 2001 10
6
11 2019
6

Prilosec

Prilosec
Prilosec

Prilosec Prilosec
Tom
McKillop


Prilosec 2002 6

Nexium

FDA Prilosec

3
Prilosec
FDA
Nexium

Claritin

Claritin
Benadryl
Claritin 80 100 Benadryl
27 1981 Claritin
1993 FDA
17 1998
2
22 6 4
4 1998 8
Claritin 4
5

Claritin Claritin
2002 Clarinex Claritin

Clarinex

2002 FDA
Claritin

3 Clarinex
Nexium

Prozac

Prozac
Barr
2000 Prozac
2003 12 2001 2
2001 8 Prozac

5- Paxil Zoloft
1999 Prozac
Prozac 6 FDA
2004 2

Prozac Sarafem
1990
Richard Wurtman
Judith Wurtman 5-
CNN
Interneuron
Indevus 1997
Prozac Interneuron
Prozac 2

Prozac Sarafem FDA


PMDD
Indevus Sarafem 2003 7
6

Sarafem Prozac Prozac


Sarafem 3 2004 Sarafem
5.7 2

Paxil

Paxil
Prozac 5-
1992
FDA 1998 Apotex Paxil

Apotex 30 9
30 17 Apotex 4
30
5 1998 2003

2002 7 FTC
FDA FDA

30

2002
[Charles SchumerD-N.Y.][John McCainR-Ariz]

30

143

2003
1965

2004

Aetna

10
4 000 400

300

5 300
Centers for Medicare & Medicaid Services CMS
5 5 500

2006

[Richard J. DurbinD-Ill.]

1999

Jim Nicholson

2000
20
200

2002 675
138
9 1
2002
120 1 4 112
1997 2002 4 7 8

2002 26
342 20
[Bill ThomasR-Calif.]
Nick Littlefield
[Edward KennedyD-Mass.]

[Evan BayhD-Ind.]

1991 2000

Parry Romani
2002 &Walker Martin & Hatch

1999 2000
2 6 5
80%
20 90

[Bill FristR-Tenn.]
[Nancy JohnsonR-Conn]

[Robert Torricelli D-N.J.]


[Joseph Lieberman D-Conn.]1999

Gulfstream

1999 1999 2000


6 5
Tim Ryan
2002
issue ads 1 8

Donald RumsfeldG. D. Searle


Pharmacia
Mitchell E. Daniels

2003
Tommy Thompson FDA
Mark McClellan[George
AllenR-Va.]

1980

1987

FDA 1997 FDA

FDA

FDA

1997 Drugdex
Drugdex
3 823

Drugdex Thomson Corporation

Drugdex
Drugdex Drugdex
2003
Drugdex 12 203
Neurontin 48 Neurontin

Drugdex

Drugdex

David Armstrong Drugdex


Drugdex

FDA FDA Drugdex

1995 20

2005 20 90

143

2004 150

2003

4
3 47

300 10 000

FDA

FDA 1992
Prescription Drug User Fee Act
FDA
31 FDA
FDA

2002
57.6
2 6
FDA
2002 500 FDA

13

FDA

Warner-Lambert
Rezulin1997
63

FDA

FDA


FDA

FDA

FDA 18
FDA
FDA

FDA2000 92%
55%

FDA

August Gribbin

[Dan BurtonR-Ind.]

FDA

2002 Alastair
Wood FDA

FDA


Raymond Woosley

FDA Mark
McClellanScott McClellan
2003

FDA

FDA 2004

FDA

FDA

Rezulins

2003

23%
1 5 7 3 4 9

FDA 5
1 2
1

50 1 8

1
50

2003

20%

Alan F. Holmer 2002

[Bernard Sanders I-Vr.]

New York Yankees

Los Angeles Lakers

1980
2000

2000

FDA

FDA

2002 7 2003

IMS Health 11
7% 140
1999 10

1987

2003 83%
7%

32 60

Procrit

FDA FDA FDA

FDA
FDA FDA


2003
SpringfieldMichael Albano
18 000
1 8 9 CanaRx
FDA

2003 12
FDA

FDA
UnitedHealth 97 000

2002 17% 8.5%

2000
FDA
Donna Shalala

2003 FDA
FDA

53

[Rick Santorum
R-Pa.]

2001

Nexium
Celebrex2001

2000

Common Cause
Chellie Pingree Rx

Rx

2003
Rx

28

Jeb
Bush

2004 4 9

2 5 7 Kaiser
Permanente Cipro

2002

Neurontin

12

Prescription Access
Litigation Project 70 Plaintiffs

PBMs
2

MerckMedco
2003 Medco
2004 4 Medco
2 930

2000 2003
Michael Loucks8

22 TAP Abbott
TAP 8 8
5 2 9 20
90 27

Claritin 50%
2003

2001

FDA 2000
314 32 7 2000
2001 2002
2003 Abbott

2003

30 30

Lipitor Celebrex
2003
25 5 25
1300 2003 63 000 4 400
2001 2003 60% TaxolGlucophage
BuSpar
Gardiner Harris

1.

2. FDA

3.

4.

5.

6.

7.

FDA

Prozac

FDA
FDA


FDA
Prozac Zoloft

FDA

FDA

FDA

FDA
FDA
FDA

FDA
FDA FDA

2007
FDA FDA


FDA
FDA

FDA
FDA
FDA

FDA

FDA

FDA

FDA


ALLHAT
FDA
FDA

FDA
6 20

FDA
FDA

30
FDA
FDA

FDA

30

6
2003

350

30

FDA

[ FDA
Mark McClellan]

500


2002 500

2003

2003

FDA

1.

2.

3.

[Arnold S.Bud Relman]

2002 12 16 The New Republic 2002


George Polk Award
2002
Daedalus 2001
6 20
1977 2000

Lara Goitein
Elizabeth Goitein
Steffie
WoolhandlerDavid HimmelsteinJoseph
Gerstein
Sidney Wolfe
James Love

Random House
Jonathan KarpJonathan JaoAmelia
ZalcmanAlice
Mautell