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

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Nexium Prilosec
2001 5
Nexium Prilosec
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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
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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
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Fluoxetine 80%
Paxil Zoloft Prilosec Mevacor
Prozac

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Prozac Prilosec Nexium
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Gleevec
Gleevec

20

140/90mmHg

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1dL
280mg 240mg 200mg

Lipitor 2002
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Hormone


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Prevacid

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Zoloft 5-

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FDA

Clarinex Claritin
FDA

5-SSRIs
Prozac

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Carl Elliott
Paxil

Paxil Barry
Brand

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911

Maureen Dowd

Lipitor Zocor

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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

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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

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1997 FDA
30

1997 FDA

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25% 64%

Paxil Zoloft
Celexa

2001 30
34 000

FDA

FDA

Lipitor 4
4

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The Big Fix
88 000
5~6

Azucena Sanchez-Scott

Washington Redskins

2000 AMA 2002

2002

HMOs
Nexium

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TAP Lupron

Lupron 65
80%

20 90 Lupron
Zoladex LupronTAP
500 350 500


Lupron

TAP 1996
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25 000
Joseph Gerstein
Gerstein
65 000

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False Claims Act TAPTAP

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100

30%


2001 30% 35%

Gleevec
Gleevec
Gleevec

NexiumLipitor Paxil

2001 191
350

Zoloft
Paxil

2001 190
350

Clarinex

350

FDA

FDA

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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

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Prozac Paxil
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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

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90

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Alex Beam

120
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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

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Colazal

CROs

FDA

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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

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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

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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

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Neurontin

30

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1994
17 20 1997 FDA
6
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3
30
6

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Prilosec 60
Prilosec
1989 FDA 2001 10
6
11 2019
6

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Prilosec Prilosec
Tom
McKillop


Prilosec 2002 6

Nexium

FDA Prilosec

3
Prilosec
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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
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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
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 Prozac Sarafem FDA

PMDD
Indevus Sarafem 2003 7
6

Sarafem Prozac Prozac

Sarafem 3 2004 Sarafem
5.7 2

Paxil

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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

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Drugdex

David Armstrong Drugdex

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1995 20

2005 20 90

143

2004 150

2003

4
3 47

 300 10 000

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FDA
31 FDA
FDA

2002
57.6
2 6
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2002 500 FDA

13

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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

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FDA FDA FDA

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FDA FDA


2003
SpringfieldMichael Albano
18 000
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2002 17% 8.5%

2000
FDA
Donna Shalala

2003 FDA
FDA

53

[Rick Santorum
R-Pa.]

2001

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Celebrex2001

2000

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Chellie Pingree Rx

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2003
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28

Jeb
Bush

2004 4 9

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2002

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Litigation Project 70 Plaintiffs

PBMs
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2003 Medco
2004 4 Medco
2 930

2000 2003
Michael Loucks8

 22 TAP Abbott
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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
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Gardiner Harris

1.

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2007
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350

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Mark McClellan]

500


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2002
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1977 2000

Lara Goitein
Elizabeth Goitein
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WoolhandlerDavid HimmelsteinJoseph
Gerstein
Sidney Wolfe
James Love

Random House
Jonathan KarpJonathan JaoAmelia
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