2 3

The Truth About the Drug Companies

Marcia Angell, M.D.

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The Truth Aboutthe Drug Companies : How they deceive us and what to do about it Marcia Angell, M.D.

NewEngland Journal of Medicine 10

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1: 2549 3,000 ISBN 974-9508-70-x 200

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= The Truth About the Drug Companies. : , 2549.

336 .1. . I. , .II. .

338. 476151ISBN 974-9508-70-x

17/118 1 10400 0 2279 9636, 0 2271 4339 0 2618 7838

The Truth Aboutthe Drug Companies : How they deceive us and what to do about it Marcia Angell, M.D.

NewEngland Journal of Medicine 10

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(1) IMS Health (www.imshealth.com), www.imshealth.com/ims/portal/front/articleC/O,2777,6599_3665_41336931,00.html 2 . FamiliesUSA, Out-of-Bounds: Rising Prescription Drug Prices for Seniors, July 2003(www.familyiesusa.org); Public Citizen Congress Watch, 2002 Drug Indrustry Profits: HeftyPharmaceutical Company Margins Dwarf Other Indrustries, June 2003 (www.citizen.org):Henry J. Kaiser Family Foundation, Prescription Drug Trends, November 2001 (www.kff.org);National Institute for Health Care Management Foundation, Prescription Drug Expendituresin 2001; Another Year of Escalating Costs, May 6,2002 (www.nihcm.org).

(2) , FamiliesUSA, Out-of-Bounds.(3) Sarah Lueck, Drug Prices Far Outpace Inflation, Wall Street Journal, July 10, 2003, D2.(4) FamiliesUSA, Out-of-Bounds.(5) FamiliesUSA, Out-of-Bounds.(6) On ABC Special with Peter Jennings, Bitter Medicine: Pills, Profit, and the Public Health,

May 29, 2002. (7) 2003

www.oligopolywatch.com/2003/05/25.html.(8) Lueck, Drug Prices.

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18 19

(12) Vasella spoke at the AARP International Forum on Prescription Drug Policy in Washing-ton, D.C., June 10, 2003.

(13) Patricia Berry, More Americans Go North for Drug, AAPR Bulletin, April 2003, 3.(14) Chandrani Ghosh and Andrew Tanzer, Patent Play, Forbes, September 17, 2001,141.(15) Gardiner Harris, Schering-Plough Is Hurt by Plummeting Pill Costs, New York Time,

July 8, 2003, C1.(16)

(.), www.fda.gov/cder/rdmt/pstable.htm.(17) Sheryl Gay Stolberg and Gardiner Harris, Measure to Ease Imports of Drugs is Gaining

in House, New York Times, July 22, 2003, A1(18) Alice Dembner, Drug Firm to Pay $ 875M Fine for Fraud, Boston Globe, October 4,

2001, A1.

(1) U.S. Centers for Medicaid Services, Office of the Actuary, Na-tional Health Statistics Group, Baltimore, Maryland CynthiaSmith, Retail Prescription Drug Spending in the National Health Accounts. HealthAffairs, January-February 2004,160.

(2) Center for Policy Alternatives, Playing Fair: State Action to Lower Prescription DrugPrices, 2000.

(3) . IMS Health, a private informationcompany and the principal source for data on global sales (www.imshealth.com). .U.S. Centers for Medicare & Medicaid Services (www.cmms.gov). . The annualreport of the industrys trade group, the Pharmaceutical Research and Manufacturers ofAmerica, Pharmaceutical Industry Profile 2002 (www.phrma.org). . National Insti-tute for Health Care Management Foundation, Prescription Drug Expenditures in 2001:Another Year of Escalating Costs, May 6, 2002 (www.nihcm.org).

(4) Public Citizen CongressWatch, Rx R & D Myths: the Case Against the Drug Industrys R & D Scare Card,July 2001 (www.citizen.org) NIHCM, Changing Patterns of PharmaceuticalInnovation, May 2002 (www.nihcm.org).

(5) Center Watch (www.centerWatch.com) Thomson Medical Economics an Industry in Evolution,3rd ed., ed. Mary Jo Lamberti (Boston: Centerwatch, 2001), 22.

(6) Families USA, Out-of-Bounds: Rising Prescription Drug Prices for Seniors. July 2003(www.familiesusa.org).

(7) Public Citizen Congress Watch, Rx R & D Myths.(8) The Fortune 500, Fortune, April 15, 2002 F26.(9) Public Citizen Congress Watch, 2002 Drug Industry Profits: Hefty Pharmaceutical Com-

pany Margins Dwarf Other Industries, June 2003 (www.citizen.org/documents/Pharma_Report.pdf). the Fortune 500 lists in Fortune, April 7,2003 and April 5, 2004,

(10) Henry J. Kaiser Family Foundation, Prescription Drug Trends, November 2001(www.kff.org).

(11) Families USA, Profiting from Pain : Where Prescription Drug Dollars Go, July 2002(www.familiesusa.org/site/DocServer/PReport. pdf? docID=249).

18 19

(12) Vasella spoke at the AARP International Forum on Prescription Drug Policy in Washing-ton, D.C., June 10, 2003.

(13) Patricia Berry, More Americans Go North for Drug, AAPR Bulletin, April 2003, 3.(14) Chandrani Ghosh and Andrew Tanzer, Patent Play, Forbes, September 17, 2001,141.(15) Gardiner Harris, Schering-Plough Is Hurt by Plummeting Pill Costs, New York Time,

July 8, 2003, C1.(16)

(.), www.fda.gov/cder/rdmt/pstable.htm.(17) Sheryl Gay Stolberg and Gardiner Harris, Measure to Ease Imports of Drugs is Gaining

in House, New York Times, July 22, 2003, A1(18) Alice Dembner, Drug Firm to Pay $ 875M Fine for Fraud, Boston Globe, October 4,

2001, A1.

(1) U.S. Centers for Medicaid Services, Office of the Actuary, Na-tional Health Statistics Group, Baltimore, Maryland CynthiaSmith, Retail Prescription Drug Spending in the National Health Accounts. HealthAffairs, January-February 2004,160.

(2) Center for Policy Alternatives, Playing Fair: State Action to Lower Prescription DrugPrices, 2000.

(3) . IMS Health, a private informationcompany and the principal source for data on global sales (www.imshealth.com). .U.S. Centers for Medicare & Medicaid Services (www.cmms.gov). . The annualreport of the industrys trade group, the Pharmaceutical Research and Manufacturers ofAmerica, Pharmaceutical Industry Profile 2002 (www.phrma.org). . National Insti-tute for Health Care Management Foundation, Prescription Drug Expenditures in 2001:Another Year of Escalating Costs, May 6, 2002 (www.nihcm.org).

(4) Public Citizen CongressWatch, Rx R & D Myths: the Case Against the Drug Industrys R & D Scare Card,July 2001 (www.citizen.org) NIHCM, Changing Patterns of PharmaceuticalInnovation, May 2002 (www.nihcm.org).

(5) Center Watch (www.centerWatch.com) Thomson Medical Economics an Industry in Evolution,3rd ed., ed. Mary Jo Lamberti (Boston: Centerwatch, 2001), 22.

(6) Families USA, Out-of-Bounds: Rising Prescription Drug Prices for Seniors. July 2003(www.familiesusa.org).

(7) Public Citizen Congress Watch, Rx R & D Myths.(8) The Fortune 500, Fortune, April 15, 2002 F26.(9) Public Citizen Congress Watch, 2002 Drug Industry Profits: Hefty Pharmaceutical Com-

pany Margins Dwarf Other Industries, June 2003 (www.citizen.org/documents/Pharma_Report.pdf). the Fortune 500 lists in Fortune, April 7,2003 and April 5, 2004,

(10) Henry J. Kaiser Family Foundation, Prescription Drug Trends, November 2001(www.kff.org).

(11) Families USA, Profiting from Pain : Where Prescription Drug Dollars Go, July 2002(www.familiesusa.org/site/DocServer/PReport. pdf? docID=249).

21

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3534

(1) Public Citizen Congress Watch, Rx R & DMyths: The Case against the Drug Industrys R & D Scare Card July 2001(www.citizen.org).

(2) Pharmaceutical Industry Profile 2002, 20 (www.phrma.org).

(3) Philip J. Hilts, Protecting Americas Health: the FDA, Busi-ness, and One Hundred Years of Regulation (New York: Alfred A. Knopf, 2003), 236.See also Approval of AZT, March 20, 1987, www.fda.gov/bbs/topics/NEWS/NEW00217.html.

(4) Mitusya, Weinhold, Yarchoan, Bolognesi, Broder, Credit Government Scientists withDeveloping Anti- AIDS Drug, New York Time, September 28, 1989. http://lists.essential.org/pharm-policy/msg00106.html.

(5) Suzanne Parisian, FDA:Inside and Out (Front Royal, Va.: Fast Horse Press, 2001) Public CitizenCongress Watch, Rx R & D Myths, appendix A.

(6) Center Watch Thomson Medical Economics(www.centerwatch.com) Center Watch, An Industry in Evolution, 3rd ed., ed. Mary

., ,

, . . . . , . ,

. , . .. 2449 . -

3534

(1) Public Citizen Congress Watch, Rx R & DMyths: The Case against the Drug Industrys R & D Scare Card July 2001(www.citizen.org).

(2) Pharmaceutical Industry Profile 2002, 20 (www.phrma.org).

(3) Philip J. Hilts, Protecting Americas Health: the FDA, Busi-ness, and One Hundred Years of Regulation (New York: Alfred A. Knopf, 2003), 236.See also Approval of AZT, March 20, 1987, www.fda.gov/bbs/topics/NEWS/NEW00217.html.

(4) Mitusya, Weinhold, Yarchoan, Bolognesi, Broder, Credit Government Scientists withDeveloping Anti- AIDS Drug, New York Time, September 28, 1989. http://lists.essential.org/pharm-policy/msg00106.html.

(5) Suzanne Parisian, FDA:Inside and Out (Front Royal, Va.: Fast Horse Press, 2001) Public CitizenCongress Watch, Rx R & D Myths, appendix A.

(6) Center Watch Thomson Medical Economics(www.centerwatch.com) Center Watch, An Industry in Evolution, 3rd ed., ed. Mary

., ,

, . . . . , . ,

. , . .. 2449 . -

36

Jo Lamberti (Boston: CenterWatch, 2001). 80,000 2.3 Naomi Aoki, Trials and Errors, Boston Globe, June 12, 2002, D1.

(7) Shifts in the Foundation of DrugDevelopment, Center Watch Monthly, January 2004, 8.

(8) Department of Health and Human Services, Office of Inspector General, RecruitingHuman Subjects: Pressures in Industry-Sponsored Clinical Research, June 2000, OEI-01-97-00195, 17.

(9) Chris Adams, FDA Inundated Trying to Assess Drug Ad Pitches, Wall Street Journal,March 14, 2002, B1.

(10) Melody Petersen, FDA Lets Others Inspect Plants Again, New York Time, April 3,2002, C3.

(11) Parisian, FDA: Inside and Out; Hilts,Protecting Americas Health; FDA Backgrounder: Mile-stones in U.S. Food and DrugLaw History, May 3, 1999 (http://vm.cfsan.fda.gov/mileston.html).

(12) Revolution at the FDA, Wall Street Journal, February 19, 2003, A14.(13) Washington Legal Foundation advertisement, In All Fairness, New York Times, De-

cember 16, 2002, A27.

37

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(7) Aoki, R & D Costs.(8) Pear, Research Cost for New Drugs.(9) Joseph A. DiMasi, Ronald W. Hansen, and Henry G. Grabowski, The Price of Innova-

tion: New Estimates of Drug Development Costs, Journal of Health Economics, vol.22 (2003), 151-85.

(10) Pear, Research Cost for New Drugs.(11) (www.fda.gov)(12) DiMasi et al., Price of Innovation, 173.(13) DiMasi et al., Price of Innovation, 151.(14) DiMasi et al., Price of Innovation, 161.(15)

www.fda.gov/orphan/taxcred.htm Larry Stevens, Big Gains, Some Strains,Some Strains, American Medical News, August 4, 2003, 5.

(16) Common Cause, Prescription for Power: How Brand-Name Drug Companies Prevailed over Consumers in Washington, June 2001, 13(www.commoncause.org)

(17) Aoki, R & D Costs.(18) Public Citizen Congress Watch, 2002 Drug Industry Profits: Hefty Pharmaceutical

Company Margins Dwarf Other Industries, June 2003 (www.citizen.org/documents/Pharma_Report.pdf).

(19) Families USA, Profiting from Pain: Where Prescription Drug Dollars Go July 2002(www.familiesusa.org/site/DocServer/PReport.pdf?docID=249).

(20) Alan Sager, Professor of Health Service at Boston University School of Public Health,quoted in Business Week Online, July 9, 2001 (www.businessweek.com).

(21) Arnold S. Relman and Marcia Angell, Americas Other Drug Problem, New Republic,December 16, 2002, 32.

, 802, , . 500 , 1 , , .(21) -. . , .

(1) Alan F. Holmer on National Public Radio, Talk of the Nation, hosted by Juan Williams,January 2, 2001.

(2) Williams Safire, The Doughnuts Hole, New York Times, October 27, 2003, A23.(3) Robert Pear, Research Cost for New Drugs Said to Soar, New York Times, Decem-

ber 1, 2001, C1.(4)

Pharmaceutical Industry Profile2002, table 1 (www.phrma.org) www.fda.gov/cder/rdmt pstable.htm

(5) Public Citizen Congress Watch, Rx R & D Myths:The Case Against the Drug Industrys R & D Scare Card, July 2001 (www.citizen.org).

(6) Naomi Aoki, R & D Costs for Drugs Skyrocket, Study Says, Boston Globe, December1, 2001, C1.

51

, - . ,. , . . , . (AlanF. Holmer), (Pharmaceu-tical Research and Manufacturers of America: PhRMA), . , (1). . ? , ?

4

52 53

. (www.fda.gov/cder/rdmt/pstable.htm) (U.S. Food and Drug Administration:FDA). 2, ,. 2

, (Chemical type). - (new molecular en-tity, NME) , 1. , (chemical derivative), . .

. ,. (priority review) , , , . (P). (standard review) (S). .

. . . , . .( , .)

5 .. 2541 .. 2545 . 415 83 . 133 ( 32). . 133 58 . 12 14 . 5 , . .. 2544 .. 2545 ( ) 7 , .. 2543, .. 2542 .. 2541 9,19 16 . .

, 14

52 53

. (www.fda.gov/cder/rdmt/pstable.htm) (U.S. Food and Drug Administration:FDA). 2, ,. 2

, (Chemical type). - (new molecular en-tity, NME) , 1. , (chemical derivative), . .

. ,. (priority review) , , , . (P). (standard review) (S). .

. . . , . .( , .)

5 .. 2541 .. 2545 . 415 83 . 133 ( 32). . 133 58 . 12 14 . 5 , . .. 2544 .. 2545 ( ) 7 , .. 2543, .. 2542 .. 2541 9,19 16 . .

, 14

54 55

2 . (Mr. Holmer) ? 35 .(2) .. 2544 7 5 2 (Novartis) 3 (Merck) (Allergan) (Gilead Sci-ences) .(3) - (Gleevec) () (Zometa) . (Cancidas) ; (Lumigan) (Glaucoma) ; (Viread) / (AZT).

7 .. 2545 , 3 ; (Zelnorm) ; (Eloxatin) - . (Hepsera) . .

. , . . . , , . , . , , .

.

. (National Institutes of Health: NIH ) ,, . ( 90 (extramural) . (intramural) ..). - (Bayh-

54 55

2 . (Mr. Holmer) ? 35 .(2) .. 2544 7 5 2 (Novartis) 3 (Merck) (Allergan) (Gilead Sci-ences) .(3) - (Gleevec) () (Zometa) . (Cancidas) ; (Lumigan) (Glaucoma) ; (Viread) / (AZT).

7 .. 2545 , 3 ; (Zelnorm) ; (Eloxatin) - . (Hepsera) . .

. , . . . , , . , . , , .

.

. (National Institutes of Health: NIH ) ,, . ( 90 (extramural) . (intramural) ..). - (Bayh-

56 57

Dole Act) - (Stevenson-Wydler Act) .. 2523. -- - . , , (royalties). , , . . 2 (National Cancer Institute) . (GlaxoSmithKline). .

.(4) , , . ,

(The Wall Street Jour-nal) (5) - 17 , 30 35 , . . . ; (6) .

(Taxol) -

(Paclitaxel) (7) (Pacific yew) .. 2503. 30 183 . .. 2534 - (Bristol-Myers Squibb) - ..2529 (Federal Tech-nology Transfer Act). -

56 57

Dole Act) - (Stevenson-Wydler Act) .. 2523. -- - . , , (royalties). , , . . 2 (National Cancer Institute) . (GlaxoSmithKline). .

.(4) , , . ,

(The Wall Street Jour-nal) (5) - 17 , 30 35 , . . . ; (6) .

(Taxol) -

(Paclitaxel) (7) (Pacific yew) .. 2503. 30 183 . .. 2534 - (Bristol-Myers Squibb) - ..2529 (Federal Tech-nology Transfer Act). -

58 59

17 . . .. 2535 , - 5 .

- . ..2537 . - . .

(, ) - 1-2 . , . . , .(8) - .

(Epogen)

.(9) -. (Erythropoietin) .. 2519 (Eugene Goldwasser) , . . , -. (Amgen) . 2 . . .

() (Procrit) - (Johnson & Johnson) (J & J).

58 59

17 . . .. 2535 , - 5 .

- . ..2537 . - . .

(, ) - 1-2 . , . . , .(8) - .

(Epogen)

.(9) -. (Erythropoietin) .. 2519 (Eugene Goldwasser) , . . , -. (Amgen) . 2 . . .

() (Procrit) - (Johnson & Johnson) (J & J).

60 61

. , , . . , . - () . . . 3 . 1 . , (Aranesp), . .

, . - . . .

.

(Gleevec)

(imatinib mesylate) .(10) . .. 2544, (chronic myeloid leukemia) ( ). (). (break throughs) . . .(11)

, . .. 2503,

60 61

. , , . . , . - () . . . 3 . 1 . , (Aranesp), . .

, . - . . .

.

(Gleevec)

(imatinib mesylate) .(10) . .. 2544, (chronic myeloid leukemia) ( ). (). (break throughs) . . .(11)

, . .. 2503,

62 63

. , . . . . , . .. 2537 .

, . (Brian J. Drukker) (Oregon Health & Sciences University) (Portland) . (Nicholas Lydon) . . , .

. . , , 2 .

.. 2542 . . 2 , . , . . (Health Affairs) , ..2541 15, 54 , 13, .(12) , . , .

.. 2543 (Public Citizen) , (Freedom of Information Act), . 5 .. 2538 (, ,, ) 16 17 . ( 1 4.)

62 63

. , . . . . , . .. 2537 .

, . (Brian J. Drukker) (Oregon Health & Sciences University) (Portland) . (Nicholas Lydon) . . , .

. . , , 2 .

.. 2542 . . 2 , . , . . (Health Affairs) , ..2541 15, 54 , 13, .(12) , . , .

.. 2543 (Public Citizen) , (Freedom of Information Act), . 5 .. 2538 (, ,, ) 16 17 . ( 1 4.)

64 65

, , 15 , 55 30 .(13)

2540 (Na-tional Bureau of Economic Research) 21 .. 2508 .. 2535, 15 .(14) (Boston Globe) 50 .. 2535 .. 2540 45 .(15) . () . . (Merrill Goozner) (The $800 Million Pill), , .(16)

,

. . .

, 10,000 20,000 - 20 . , -

- , . , 5 , 3 . .. 2546, 35 9 ( 0.5 ). , -

(Medicare). 27,000 /

. , (DanielVasella) .(17) , . . . , . .. 2546 , , . ,

64 65

, , 15 , 55 30 .(13)

2540 (Na-tional Bureau of Economic Research) 21 .. 2508 .. 2535, 15 .(14) (Boston Globe) 50 .. 2535 .. 2540 45 .(15) . () . . (Merrill Goozner) (The $800 Million Pill), , .(16)

,

. . .

, 10,000 20,000 - 20 . , -

- , . , 5 , 3 . .. 2546, 35 9 ( 0.5 ). , -

(Medicare). 27,000 /

. , (DanielVasella) .(17) , . . . , . .. 2546 , , . ,

66 67

..(18)

(Cerezyme) (Genzyme). (Gauchers disease), 5,000 . , . ( (Roscoe Brady) , ). 200,000 300,000 /. (Merrill Goozner) . , . . ,.(19)

(Roche) / (Fuzeon).(20) .. 2546, . (The Wall Street Journal) (Vanessa Fuhrmans) (Duke University) .

, 20,000 // . (AIDS Drug Assistance Programs) . , , , . 13 , . , , 13 . , . .

.

- - .(21) , , , , .

66 67

..(18)

(Cerezyme) (Genzyme). (Gauchers disease), 5,000 . , . ( (Roscoe Brady) , ). 200,000 300,000 /. (Merrill Goozner) . , . . ,.(19)

(Roche) / (Fuzeon).(20) .. 2546, . (The Wall Street Journal) (Vanessa Fuhrmans) (Duke University) .

, 20,000 // . (AIDS Drug Assistance Programs) . , , , . 13 , . , , 13 . , . .

.

- - .(21) , , , , .

68 69

. , . , - . .. 2538, . - ., . . , . .

, . , . . , , . ,

. , , .

. (, .) , .. 2538, .. 2531 , , . , , , .(22) . , - .

.. 2544, (RonWyden) , 47 . ( ) , .

68 69

. , . , - . .. 2538, . - ., . . , . .

, . , . . , , . ,

. , , .

. (, .) , .. 2538, .. 2531 , , . , , , .(22) . , - .

.. 2544, (RonWyden) , 47 . ( ) , .

70 71

43 . , / . ( 4 47 ), . , , -.

- . . . , 300 30 17 . .. 2513. , .

-, ?, ,

, . . - (- ) ? , . , , ., , . ?

. , . , . . , , . , .

, .

70 71

43 . , / . ( 4 47 ), . , , -.

- . . . , 300 30 17 . .. 2513. , .

-, ?, ,

, . . - (- ) ? , . , , ., , . ?

. , . , . . , , . , .

, .

72 73

. , . . . . , . .

, . ,. , , , . - (me-too drugs). -

(1) Vicki Kemper, Drug Industry Poised to Recap Political Dividends, Los Angeles Times,November 8, 2002, A15.

(2) www.phrma.org/whoweare/members Pharmaceutical Industry Pro-file 2002.

(3) www.fda.gov/cder/rdmt/ndaaps02cy.htm Physicians Desk Reference, 58th ed., (Montvale, N.J.:Thomson PDR, 2004) or(www.PDR.net).

(4) CenterWatch, www.centerwatch.com,An Industry in Evolution, 3rd ed.,ed. Mary Jo Lamberti (Boston: CenterWatch, 2001), 22; Gautam Naik, Glaxo SmithKline Actively Pursues Drug Licenses, Wall StreetJournal, February 13, 2002, B2.

(5) Naik, Glayo SmithKline Activety Pursues Drug Licevises,(6) Naik, Glaxo SmithKline Actively Pursues Drug Licenses,(7) the watchdog group Consumer

Project on Technology: Susannah Markandya and James Love, Timeline of PaclitaxelDisputes, August 23, 2001 (www.cptech. org). Public Citizen Health ResearchGroups Health Letter, Taxol: How the NIH Gave Away the Store, August 2003, 12;Peter Landers, U.S. Recoups Modest Sum on Taxol, Wall Street Journal, June 9,2003, B7; Common Cause, Prescription for Power: How Brand-Name Drug CompaniesPrevailed over Consumers in Washington, June 2001, 13 (www.commoncause.org);Eliot Marshall, Universities, NIH Hear the Price Isnt Right on Essential Drugs, Sci-ence, April 27, 2001, 614 (www.sciencemag,org).

(8) www.fda.gov/cder/ob www.uspto.gov 5,157,049 U.S. Department of Health and HumanServices 20 .. 2535 Florida state Univer-sity Office of Research, Office of Technology Transfer (www.techtransfer.fsu.edu).

(9) Arnold S. Relman and Marcia Angell, Americas Other DrugProblem, New Republic, December 16, 2002, 31. Also Merrill Goozner, The PriceIsnt Right, American Prospect, September 11, 2000 (www.prospect.org); Paul Elias,Suit Against Columbia Highlights Issue of University Patents, Boston Globe, April 28,2003,A7; Naomi Aoki, Biotech Firms Sue Columbia University, Boston Globe, July 16,

72 73

. , . . . . , . .

, . ,. , , , . - (me-too drugs). -

(1) Vicki Kemper, Drug Industry Poised to Recap Political Dividends, Los Angeles Times,November 8, 2002, A15.

(2) www.phrma.org/whoweare/members Pharmaceutical Industry Pro-file 2002.

(3) www.fda.gov/cder/rdmt/ndaaps02cy.htm Physicians Desk Reference, 58th ed., (Montvale, N.J.:Thomson PDR, 2004) or(www.PDR.net).

(4) CenterWatch, www.centerwatch.com,An Industry in Evolution, 3rd ed.,ed. Mary Jo Lamberti (Boston: CenterWatch, 2001), 22; Gautam Naik, Glaxo SmithKline Actively Pursues Drug Licenses, Wall StreetJournal, February 13, 2002, B2.

(5) Naik, Glayo SmithKline Activety Pursues Drug Licevises,(6) Naik, Glaxo SmithKline Actively Pursues Drug Licenses,(7) the watchdog group Consumer

Project on Technology: Susannah Markandya and James Love, Timeline of PaclitaxelDisputes, August 23, 2001 (www.cptech. org). Public Citizen Health ResearchGroups Health Letter, Taxol: How the NIH Gave Away the Store, August 2003, 12;Peter Landers, U.S. Recoups Modest Sum on Taxol, Wall Street Journal, June 9,2003, B7; Common Cause, Prescription for Power: How Brand-Name Drug CompaniesPrevailed over Consumers in Washington, June 2001, 13 (www.commoncause.org);Eliot Marshall, Universities, NIH Hear the Price Isnt Right on Essential Drugs, Sci-ence, April 27, 2001, 614 (www.sciencemag,org).

(8) www.fda.gov/cder/ob www.uspto.gov 5,157,049 U.S. Department of Health and HumanServices 20 .. 2535 Florida state Univer-sity Office of Research, Office of Technology Transfer (www.techtransfer.fsu.edu).

(9) Arnold S. Relman and Marcia Angell, Americas Other DrugProblem, New Republic, December 16, 2002, 31. Also Merrill Goozner, The PriceIsnt Right, American Prospect, September 11, 2000 (www.prospect.org); Paul Elias,Suit Against Columbia Highlights Issue of University Patents, Boston Globe, April 28,2003,A7; Naomi Aoki, Biotech Firms Sue Columbia University, Boston Globe, July 16,

74 75

2003, C1; Antheny Shadid, A U.S. Share of Royalties on Research Proposed, BostonGlobe, August 22, 2001, A1.

(10) Relman and Angell, Americas Other Drug Problem, 31. Thiswas based in part on personal conversations between Relman and Dr. Brian J.Druker.Also James Love, Consumer Project on Technology (www.cptech.org/ip/health/gleevec);Charles L. Sawyers, Medical Progress: Chronic Myeloid Leukemia, New EnglandJournal of Medicine, April 29, 1999, 1330 (www.nejm.org).

(11) The ad appeared, for example, in The New Yorker, February 9, 2004, 25. Also, for theNovartis view, see Daniel Vasella, with Robert Slater, Magic Cancer Bullet: How a TinyOrange Pill Is Rewriting Medical History (New York: Harper Collins, 2003); and a reviewby Arnold S. Relman, Journal of the American Medical Association, October 22/29,2003, 2194.

(12) Darren E. Zinner, Medical R & D at the Turn of the Millennium, Health Affairs,September-October 2001, 202.

(13) Public Citizen Congress Watch, Rx R & D Myths: The Case against the Drug IndustrysR&D Scare Card, July 2001 (www.citizen.org).

(14) U.S. Congress, Joint Economic Committee, The Benefits of Medical Research and theRole of the NIH, May 2000, http://jec.senate.gov.

(15) Alice Dembner, Public Handouts Enrich Drug Makers, Scientists, Boston Globe, April5, 1998, A1.

(16) Merrill Goozner, The $800 million Pill: The Truth Behind the Cost of New Drugs (Berke-ley: University of California Press, 2004).

(17) Vasella, with Slater, Magic Cancer Bullet.(18) www.cptech.org/ip/health/gleevec; Stephanie

Strom and Matt Fleischer-Black, Questions on Choice of Foundation for Drug Program,New York Time, June 5, 2003,C7;IANS, Novartis Stops Donation of Cancer Drug toIndia, June 6, 2003, (www.newindpress.com); the complaint was made to DanielVasella by a member of the audience at the AARP International Forum on PrescriptionDrug Policy in Washington, D.C., June 10, 2003.

(19) Goozner, Price Isnt Right.(20) Vanessa Fuhrmans, Costly New Drug for AIDS Means Some

Go Without, Wall Street Journal, January 13, 2004, A1.(21) Council on Governmental Relations, the Bayh-Dole Act: A Guide

to the Law and Implementing regulations, October 1999 (www.cogr.edu/docs/Bayh_Dole.pdf). Also see Peter S. Arno and Michael H. Davis, Why Dont We EnforceExisting Drug Price Controls? Tulane Law Review, vol. 75, no. 3 (2001); Eyal Press andJennifer Washburn, The Kept University, Atlantic Monthly, March 2000, 39.

(22) Department of Health and Human Ser-vices, National Institutes of Health, NIH Response to the Conference Report Requestfor a Plan to Ensure Taxpayers Interests Are Protected, July 2001 (www.nih.gov/news/070101wyden.ht).

74 75

2003, C1; Antheny Shadid, A U.S. Share of Royalties on Research Proposed, BostonGlobe, August 22, 2001, A1.

(10) Relman and Angell, Americas Other Drug Problem, 31. Thiswas based in part on personal conversations between Relman and Dr. Brian J.Druker.Also James Love, Consumer Project on Technology (www.cptech.org/ip/health/gleevec);Charles L. Sawyers, Medical Progress: Chronic Myeloid Leukemia, New EnglandJournal of Medicine, April 29, 1999, 1330 (www.nejm.org).

(11) The ad appeared, for example, in The New Yorker, February 9, 2004, 25. Also, for theNovartis view, see Daniel Vasella, with Robert Slater, Magic Cancer Bullet: How a TinyOrange Pill Is Rewriting Medical History (New York: Harper Collins, 2003); and a reviewby Arnold S. Relman, Journal of the American Medical Association, October 22/29,2003, 2194.

(12) Darren E. Zinner, Medical R & D at the Turn of the Millennium, Health Affairs,September-October 2001, 202.

(13) Public Citizen Congress Watch, Rx R & D Myths: The Case against the Drug IndustrysR&D Scare Card, July 2001 (www.citizen.org).

(14) U.S. Congress, Joint Economic Committee, The Benefits of Medical Research and theRole of the NIH, May 2000, http://jec.senate.gov.

(15) Alice Dembner, Public Handouts Enrich Drug Makers, Scientists, Boston Globe, April5, 1998, A1.

(16) Merrill Goozner, The $800 million Pill: The Truth Behind the Cost of New Drugs (Berke-ley: University of California Press, 2004).

(17) Vasella, with Slater, Magic Cancer Bullet.(18) www.cptech.org/ip/health/gleevec; Stephanie

Strom and Matt Fleischer-Black, Questions on Choice of Foundation for Drug Program,New York Time, June 5, 2003,C7;IANS, Novartis Stops Donation of Cancer Drug toIndia, June 6, 2003, (www.newindpress.com); the complaint was made to DanielVasella by a member of the audience at the AARP International Forum on PrescriptionDrug Policy in Washington, D.C., June 10, 2003.

(19) Goozner, Price Isnt Right.(20) Vanessa Fuhrmans, Costly New Drug for AIDS Means Some

Go Without, Wall Street Journal, January 13, 2004, A1.(21) Council on Governmental Relations, the Bayh-Dole Act: A Guide

to the Law and Implementing regulations, October 1999 (www.cogr.edu/docs/Bayh_Dole.pdf). Also see Peter S. Arno and Michael H. Davis, Why Dont We EnforceExisting Drug Price Controls? Tulane Law Review, vol. 75, no. 3 (2001); Eyal Press andJennifer Washburn, The Kept University, Atlantic Monthly, March 2000, 39.

(22) Department of Health and Human Ser-vices, National Institutes of Health, NIH Response to the Conference Report Requestfor a Plan to Ensure Taxpayers Interests Are Protected, July 2001 (www.nih.gov/news/070101wyden.ht).

77

. . . . ., , .

. - (me-too drugs) . , . . (1)

. 5 .. 2541 .. 2545 415 , 14 . 9 . 77 -

5- (Me-Too Drugs)

78 79

. .

, , . . (Nexium) (heartburn) (proton pump inhibitor) .. 2544 .. , . 6 . ,

() , . - () (omeprazole molecule). - ( --

- . . . 77 (2)

- . () . .(3) . () . . .

. -. - .

78 79

. .

, , . . (Nexium) (heartburn) (proton pump inhibitor) .. 2544 .. , . 6 . ,

() , . - () (omeprazole molecule). - ( --

- . . . 77 (2)

- . () . .(3) . () . . .

. -. - .

80 81

. () . -

( 20 10 20) . 20 40 - 20 . (-), , (5) . -, - 4 ( ). (Tom Scully) (Centers for Medicare & Medicaid Services) (6)

(Clarinex) . (Claritin)-

) . (4)

, . . , - , . .. 2544. --. . . . ( )

. . , .

80 81

. () . -

( 20 10 20) . 20 40 - 20 . (-), , (5) . -, - 4 ( ). (Tom Scully) (Centers for Medicare & Medicaid Services) (6)

(Clarinex) . (Claritin)-

) . (4)

, . . , - , . .. 2544. --. . . . ( )

. . , .

82 83

- (statins) .(8) ..2546 (Crestor) . (Mevacor) (Merck) .. 2530 . . . - (Zocor), - (Lipitor) (Pfizer), - (Pravachol) - , (Lescol) (Novartis) ()(9)

. ,- . , ,

-,

.. 2545.(7) . .. 2544 2,700 1 3 -. .. 2530 (metabolite) - , . .. 2544 . . . - . . . , -.

- -

. . 3 . 2

82 83

- (statins) .(8) ..2546 (Crestor) . (Mevacor) (Merck) .. 2530 . . . - (Zocor), - (Lipitor) (Pfizer), - (Pravachol) - , (Lescol) (Novartis) ()(9)

. ,- . , ,

-,

.. 2545.(7) . .. 2544 2,700 1 3 -. .. 2530 (metabolite) - , . .. 2544 . . . - . . . , -.

- -

. . 3 . 2

84 85

(Prozac) (Eli Lilly) (selective serotonin reuptake inhibitors: SSRIs). . .. 2530 , ..2537 (obsessive-compulsive dis-order), .. 2539 (bulimia), .. 2542 . . - 2,600 . , . (Paxil) .. 2540, (Zoloft) .. 2542. (Forest Laboratories) (Celexa), -- (Lexapro). .. 2544, (Fluoxetine) 80. -.

. . . -

- ., -.. - . .. 2541 80 . 40 . . 80 . .(10) ?. , . .(11) - . . .

(lovastatin) . - , .. 2545. .(12)

84 85

(Prozac) (Eli Lilly) (selective serotonin reuptake inhibitors: SSRIs). . .. 2530 , ..2537 (obsessive-compulsive dis-order), .. 2539 (bulimia), .. 2542 . . - 2,600 . , . (Paxil) .. 2540, (Zoloft) .. 2542. (Forest Laboratories) (Celexa), -- (Lexapro). .. 2544, (Fluoxetine) 80. -.

. . . -

- ., -.. - . .. 2541 80 . 40 . . 80 . .(10) ?. , . .(11) - . . .

(lovastatin) . - , .. 2545. .(12)

86 87

) . , . ,, . ,

3 . (hypertension) . 140/90. (prehypertension )(14) 120/80 140/90. . , , . -

. 280 / . 240,

(Sarafem), , (premenstrualdysphoric disorder). , , (13)

- - .

. - . . . , . . ( ) . () . ,

2 . . , (sleeping sickness) (schistosomiasis- 3

86 87

) . , . ,, . ,

3 . (hypertension) . 140/90. (prehypertension )(14) 120/80 140/90. . , , . -

. 280 / . 240,

(Sarafem), , (premenstrualdysphoric disorder). , , (13)

- - .

. - . . . , . . ( ) . () . ,

2 . . , (sleeping sickness) (schistosomiasis- 3

88 89

( ) (Prevacid)

. - (premenstrual dysphoric disorder, PMDD). . , -, ? , .-

(Erectile dysfunction), (Viagra), - 2 (Levitra) (Cialis) . , . , , , . (15)

200. , . .. 2545, . -

. . , .

.. . . . (acid reflux disease gastroesophageal reflux disease, GERD) , -. .. 2545,

88 89

( ) (Prevacid)

. - (premenstrual dysphoric disorder, PMDD). . , -, ? , .-

(Erectile dysfunction), (Viagra), - 2 (Levitra) (Cialis) . , . , , , . (15)

200. , . .. 2545, . -

. . , .

.. . . . (acid reflux disease gastroesophageal reflux disease, GERD) , -. .. 2545,

90 91

(16) , . (Barry Brand) (Ad-vertising Age) . (17)

(generalizedanxiety disorder) 11 .. 2544 . ? () . (Maureen Dowd), (18)

--?

2 . ?

- . . , . . - . . , 4 ,

. . - . (social anxiety disorder), . ? (Carl Elliott) (bioethicist) . ,

90 91

(16) , . (Barry Brand) (Ad-vertising Age) . (17)

(generalizedanxiety disorder) 11 .. 2544 . ? () . (Maureen Dowd), (18)

--?

2 . ?

- . . , . . - . . , 4 ,

. . - . (social anxiety disorder), . ? (Carl Elliott) (bioethicist) . ,

92 93

.

- . . - . (Angiotensin-converting-en-zyme inhibitors: ACE inhibitors) . (Dr. RobertTemple), - . (19)

-,

, .(20) , . --. , . (Mark Goldberger)

-. - -. ? - -, . - . - .

, . , . . . -. ,- . -.

92 93

.

- . . - . (Angiotensin-converting-en-zyme inhibitors: ACE inhibitors) . (Dr. RobertTemple), - . (19)

-,

, .(20) , . --. , . (Mark Goldberger)

-. - -. ? - -, . - . - .

, . , . . . -. ,- . -.

94 95

-. . . (American Home Products) (Wyeth) - (isoproterenol) (22)

- . ? - , . . . - --. , .

(21) .. 2544 , , , , , , ,

. .. 2543 , (Centers for Disease Control/CDC) . , . , .. 2545. . ,

.. 2537 -. , . , ?

94 95

-. . . (American Home Products) (Wyeth) - (isoproterenol) (22)

- . ? - , . . . - --. , .

(21) .. 2544 , , , , , , ,

. .. 2543 , (Centers for Disease Control/CDC) . , . , .. 2545. . ,

.. 2537 -. , . , ?

96 97

released February 25, 2003 (www.imshealth.com).(13) Arnold S. Relman And Marcia Angell, Americans Other Drug Problem,

New Republic, December 16, 2002, 38, Prozac Sarafem; Prozac Erica Goode, Researchers Scramble for theNext Prozac, Seattle Times, June 30, 2002, A7. Physicians Desk Reference, 58th ed.

(14) Denise Grady, U.S. Guidelines Are Reassessing Blood Pressure, New York Time,May 15, 2003, A1.

(15) Melody Petersen, Advertising New York Times, July 18, 2003, C5.(16) Shankar Vedantam, Drug Ads Hyping Anxiety Make Some Uneasy, Washington Post,

July 16, 2001, A1.(17) Vedantam, Drug Ads Hyping Anxiety.(18) Maureen Dowd, Aloft on Bozoloft, New York Times, July 3, 2002, A23.(19) Gardiner Harris, 2 Cancer Drugs, No Comparative Data, New York Times, February

26, 2004, C1.(20) , Melody Petersen, Drug Shortages

Become a Worry at Hospitals Around the Country, New York Times, January 3, 2001,A1; Julie Appleby, Hospitals, Patients Run Short of Key Drugs, USA Today, July 11,2001, 1A; Gardiner Harris, CDC Warns Vaccine Supply Is in Jeopardy, Wall StreetJournal, February 11, 2002, A3.

(21) Appleby, Hospitals, Patients Run Short,(22) Petersen, Drug Shortages.

(1) - National Institute for Health Care Management Foundation,Changing Patterns of Pharmaceutical Innovation, May 2002 (www.nihcm.org).

(2) FDA www.fda.gov/cder/rdmt/pstable.html.(3) Kefauver-Harris Drug Amendment of 1962

; , .

(4) Gardiner Harris Prilosec Nexium. As a Patent Expires, Drug Firm Lines Up Pricey Alternative,Wall Street Journal, June 6, 2002, A1; Two Fronts in Heartburn Market Battle,New York Times, August 20, 2003, C12. Neil Swidey, The CostlyCase of the Purple Pill, Boston Globe Magazine, November 17, 2002, 11; FDA FDA www.fda.gov/search/databass.html.

(5) , Physicians Desk Reference, 56th ed. (Montvale,N.J.: Thomson PDR, 2002), p. 621 (www.pdr.net).

(6) Harris, Two Fronts.(7) , Stephen S. Hall,

Prescription for Profit, New York Times Magazine, March11, 2001, 40. Claritin, Gardiner Harris, Schering-Plough Wins New Approvalfor Allergy Drug, Wall Street Journal, February 12, 2002, B10 Schering-PloughFaces a Future with Coffers Unfortified by Claritin, Wall Street Journal, March 22,2002, A1.

(8) Christopher Rowland, Ad Spending Soars as Cholesterol Fighters Duel, Boston Globe,July 30, 2003, D1; Francesca Lunzer kritz, Statins, at the Heart of a New CholesterolCampaign, Washington Post, July 31, 2001, F6. Physicians Desk Reference, 58th ed.

(9) David Brown, Cholesterol Drug Taken Off the Market, Washington Post, August 9,2001, A1.

(10) Ron Winslow, Study Signals How Low to Go on Cholesterol, Wall Street Journal,November 13, 2003, D1.

(11) Alicia Ault, A Statin Too Far ? Washington Post, August 12, 2003, F5.(12) IMS Health, World Review for 2002, data

96 97

released February 25, 2003 (www.imshealth.com).(13) Arnold S. Relman And Marcia Angell, Americans Other Drug Problem,

New Republic, December 16, 2002, 38, Prozac Sarafem; Prozac Erica Goode, Researchers Scramble for theNext Prozac, Seattle Times, June 30, 2002, A7. Physicians Desk Reference, 58th ed.

(14) Denise Grady, U.S. Guidelines Are Reassessing Blood Pressure, New York Time,May 15, 2003, A1.

(15) Melody Petersen, Advertising New York Times, July 18, 2003, C5.(16) Shankar Vedantam, Drug Ads Hyping Anxiety Make Some Uneasy, Washington Post,

July 16, 2001, A1.(17) Vedantam, Drug Ads Hyping Anxiety.(18) Maureen Dowd, Aloft on Bozoloft, New York Times, July 3, 2002, A23.(19) Gardiner Harris, 2 Cancer Drugs, No Comparative Data, New York Times, February

26, 2004, C1.(20) , Melody Petersen, Drug Shortages

Become a Worry at Hospitals Around the Country, New York Times, January 3, 2001,A1; Julie Appleby, Hospitals, Patients Run Short of Key Drugs, USA Today, July 11,2001, 1A; Gardiner Harris, CDC Warns Vaccine Supply Is in Jeopardy, Wall StreetJournal, February 11, 2002, A3.

(21) Appleby, Hospitals, Patients Run Short,(22) Petersen, Drug Shortages.

(1) - National Institute for Health Care Management Foundation,Changing Patterns of Pharmaceutical Innovation, May 2002 (www.nihcm.org).

(2) FDA www.fda.gov/cder/rdmt/pstable.html.(3) Kefauver-Harris Drug Amendment of 1962

; , .

(4) Gardiner Harris Prilosec Nexium. As a Patent Expires, Drug Firm Lines Up Pricey Alternative,Wall Street Journal, June 6, 2002, A1; Two Fronts in Heartburn Market Battle,New York Times, August 20, 2003, C12. Neil Swidey, The CostlyCase of the Purple Pill, Boston Globe Magazine, November 17, 2002, 11; FDA FDA www.fda.gov/search/databass.html.

(5) , Physicians Desk Reference, 56th ed. (Montvale,N.J.: Thomson PDR, 2002), p. 621 (www.pdr.net).

(6) Harris, Two Fronts.(7) , Stephen S. Hall,

Prescription for Profit, New York Times Magazine, March11, 2001, 40. Claritin, Gardiner Harris, Schering-Plough Wins New Approvalfor Allergy Drug, Wall Street Journal, February 12, 2002, B10 Schering-PloughFaces a Future with Coffers Unfortified by Claritin, Wall Street Journal, March 22,2002, A1.

(8) Christopher Rowland, Ad Spending Soars as Cholesterol Fighters Duel, Boston Globe,July 30, 2003, D1; Francesca Lunzer kritz, Statins, at the Heart of a New CholesterolCampaign, Washington Post, July 31, 2001, F6. Physicians Desk Reference, 58th ed.

(9) David Brown, Cholesterol Drug Taken Off the Market, Washington Post, August 9,2001, A1.

(10) Ron Winslow, Study Signals How Low to Go on Cholesterol, Wall Street Journal,November 13, 2003, D1.

(11) Alicia Ault, A Statin Too Far ? Washington Post, August 12, 2003, F5.(12) IMS Health, World Review for 2002, data

99

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100 101

(The Journal of the American Medical Associa-tion) -. -. , . . , (3)

. ,. . .. 2539 - .(4) . .. 2525 56 , 27. . .. 2544 .

. (ALLHAT Antihypertensiveand Lipid-Lowering Treatment to Prevent Heart Attack Trial), . .(1) , (National Heart, Lung and Blood Institute) (National Institutes of Health: NIH) . 8 42,000 , . 4 1) (calcium channel blocker) (Norvasc) 5 .. 2545(2)2) - (alpha-adrenergic blocker) (Cardura) - (doxazosin) 3) - (angiotensin-converting enzyme-ACE inhibitor) (Zestril) (Prinivil) (Merck) (lisinopril) 4) (water pill)

.. 2545

100 101

(The Journal of the American Medical Associa-tion) -. -. , . . , (3)

. ,. . .. 2539 - .(4) . .. 2525 56 , 27. . .. 2544 .

. (ALLHAT Antihypertensiveand Lipid-Lowering Treatment to Prevent Heart Attack Trial), . .(1) , (National Heart, Lung and Blood Institute) (National Institutes of Health: NIH) . 8 42,000 , . 4 1) (calcium channel blocker) (Norvasc) 5 .. 2545(2)2) - (alpha-adrenergic blocker) (Cardura) - (doxazosin) 3) - (angiotensin-converting enzyme-ACE inhibitor) (Zestril) (Prinivil) (Merck) (lisinopril) 4) (water pill)

.. 2545

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106 107

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-. , , . . , (11) . , .

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108 109

. .. 2546 - (13) () . , .. 2538 (Harold Varmus) . ,

, (National Institute of Arthritis and Musculoskeletal and Skin Diseases); (NIH ClinicalCenter-); , ,, (National Institute of Diabetes and Digestive and Kidney Diseases); (National HumanGenome Research Institute). 179,000 .. 2546 1.4 11

,. 20 . , , , , . . . (The BostonGlobe) .. 2541 .(12) .

. , . , , ,

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. .. 2546 - (13) () . , .. 2538 (Harold Varmus) . ,

, (National Institute of Arthritis and Musculoskeletal and Skin Diseases); (NIH ClinicalCenter-); , ,, (National Institute of Diabetes and Digestive and Kidney Diseases); (National HumanGenome Research Institute). 179,000 .. 2546 1.4 11

,. 20 . , , , , . . . (The BostonGlobe) .. 2541 .(12) .

. , . , , ,

110 111

. -. (14) ..2547, , (Senate Appropriations Subcom-mittee on Labor, Health and Human Services, and Education) , (U.S. General Accounting Office). (Blue Ribbon Panel)

-

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865,000

, , , . , , . . ( .) .. 2546, 94 2,259 .

, , , , . ..

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-

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, , , . , , . . ( .) .. 2546, 94 2,259 .

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112 113

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. . , -. 5 ; , . , . - 30 (22)

... () () . (20)

. ,. . (21) .. 2539 (Immune ResponseCorporation) . (Dr. James O.Kahn) . (Dr. Stephen W. Lagakos) (multicenter) (Remune). , (Therapeutic vaccine). 2,500 77.

3 . ().

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. , . 5-10 . , , . () . . ()

. . , -. 5 ; , . , . - 30 (22)

... () () . (20)

. ,. . (21) .. 2539 (Immune ResponseCorporation) . (Dr. James O.Kahn) . (Dr. Stephen W. Lagakos) (multicenter) (Remune). , (Therapeutic vaccine). 2,500 77.

3 . ().

116 117

, , . ()

.. 2545 . - . , . . (Freedom of InformationAct- ), , 6 .. 2530-2542 , , , , ()(23) 42

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. . .

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, . . , -.

(nihilism) --. , , , , , , . ,

(1) The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group,Major Outcomes in High-Risk High-Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs. Diuretic, Journal of theAmerican Medical Association, December 18, 2002, 2981. Ron Winslow and Scott Hensley Study QuestionsHigh-Cost Drugs for Hypertension Wall Street Journal, December 18, 2002, A1; LawrenceK. Altman, Older Way to Treat Hypertension Found Best, New York Times, Decem-ber 18, 2002, A1.

(2) IMS Health, World Review for 2002, datareleased February 25, 2003 (www.imshealth.com).

118 119

. . .

. - . ? ? .

() . , , . (24)

, . . , -.

(nihilism) --. , , , , , , . ,

(1) The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group,Major Outcomes in High-Risk High-Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs. Diuretic, Journal of theAmerican Medical Association, December 18, 2002, 2981. Ron Winslow and Scott Hensley Study QuestionsHigh-Cost Drugs for Hypertension Wall Street Journal, December 18, 2002, A1; LawrenceK. Altman, Older Way to Treat Hypertension Found Best, New York Times, Decem-ber 18, 2002, A1.

(2) IMS Health, World Review for 2002, datareleased February 25, 2003 (www.imshealth.com).

120 121

(16) Bekelman et al., Scope and Impact.(17) H.T. Stelfox et al.,Conflict of Interest in the Debate over Calcium-Channel Antagonists,

New England Journal of Medicine, January 8, 1998, 101.(18) The British Medical Journal

. , www.bmi.org. Silvio Garattini et al., How Can Re-search Ethics Committees Protect Patients Better? British Medical Journal, May 31,2003, 1199; Frank van Kolfschooten, Can You Believe What YouRead? Nature, March 28, 2002, 360.

(19) Bodil Als-Nielsen et al., Association of Funding and Conclusions in Randomized DrugTrials, Journal of the American Medical Associations, August 20, 2003, 921.

(20) Susan Okie, Missing Data on Celebrex: Full Study Altered Picture of Drug, Washing-ton Post, August 5, 2001, A11.

(21) . Philip J. Hilts,Company Tried to Bar Report That HIV Vaccine Failed, New York Times, November1, 2000, A 26; Richard Saltus, AIDS Drug Researchers Say Firm Pressured Them,Boston Globe, November 1, 2000, A3; Thomas M. Burton, Unfavorable Drug StudySparks Battle over Publication of Results, Wall Street Journal, November 1, 2000, B1;Carol Cruzan Morton, Company, Researchers Battle over Data Access, Science,November 10, 2000, 1063. , .

(22) Birch and Cohn, Of Patients and Profits.(23) Prozac

FDA, . Irving Kirsch andThomas J. Moore, The Emperors New Drugs: An Analysis of Antidepressant Medica-tion Data Submitted to the U.S. Food and Drug Administration, Prevention & Treat-ment, July 15, 2002.

(24) Wayne Kondro and Barbara Sibbald, Drug Company Experts AdvisedStaff to Withhold Data About SSRI Use in Children, Canadian Medical Association

(3) Winslow and Hensley, Study Questions High-Cost Drugs.(4) Altman, Older Way.(5) Families USA, Bitter Pill: The Rising Prices of Prescription Drugs for Older Americans,

June 2002 (www.familiesusa.org).(6) Winslow and Hensley, Study Questions High-Cost Drugs.(7) Altman, Older Way.(8) Lindon M. H. Wing et al., A Comparison of Outcomes with Angiotensin-Converting-

Enzyme Inhibitors and Diuretics for Hypertension in the Elderly, New England Journalof Medicine, February 13, 2003,583.

(9) Harvard Medical School , . , Liz Kowalczys : Beth Israel Seeks Deal with DrugCompany, Boston Globe, February 14, 2001, A1; Harvard to Use Caution with Merck,Boston Globe, August 1, 2001,A1; Lucrative Licensing Deals with Drug, Biotech FirmsAre Raising Ethics Issues for Hospitals, Boston Globe, March 24, 2002, C1. Raja Mishra, Harvard May Ease Rules on Faculty Ties to Drug Firms,Boston Globe, June 9, 2003, A1. Millennium Partners.

(10) Justin E. Bekelman et al., Scope and Impact of Financial Conflicts of Interest inBiomedical Research, Journal of the American Medical Association, January 22-29,2003, 454.

(11) Kevin A. Schulman et al., A National Survey of Provisions in Clinical Trial AgreementsBetween Medical Schools and Industry Sponsors, New England Journal of Medicine,October 24, 2002, 1335.

(12) Alison Bass, Drug Companies Enrich Brown Professor, Boston Globe,October 4, 1999, A1; Douglas M. Birch and Gary Cohn, Of Patients andProfits: Standing Up to Industry, Baltimore Sun, June 26, 2001, A1.

(13) David Willman, Stealth Merger: Drug Companies and Government Medical Research,Los Angeles Times, December 7, 2003, A1.

(14) Subverting U.S. Health editorial, Los Angeles Times, December 7, 2003, M4.(15) ,

Thomas Bodenheimer, Uneasy Alliance: Clinical Investigators and the PharmaceuticalIndustry, New England Journal of Medicine, May 18, 2000, 1539.

120 121

(16) Bekelman et al., Scope and Impact.(17) H.T. Stelfox et al.,Conflict of Interest in the Debate over Calcium-Channel Antagonists,

New England Journal of Medicine, January 8, 1998, 101.(18) The British Medical Journal

. , www.bmi.org. Silvio Garattini et al., How Can Re-search Ethics Committees Protect Patients Better? British Medical Journal, May 31,2003, 1199; Frank van Kolfschooten, Can You Believe What YouRead? Nature, March 28, 2002, 360.

(19) Bodil Als-Nielsen et al., Association of Funding and Conclusions in Randomized DrugTrials, Journal of the American Medical Associations, August 20, 2003, 921.

(20) Susan Okie, Missing Data on Celebrex: Full Study Altered Picture of Drug, Washing-ton Post, August 5, 2001, A11.

(21) . Philip J. Hilts,Company Tried to Bar Report That HIV Vaccine Failed, New York Times, November1, 2000, A 26; Richard Saltus, AIDS Drug Researchers Say Firm Pressured Them,Boston Globe, November 1, 2000, A3; Thomas M. Burton, Unfavorable Drug StudySparks Battle over Publication of Results, Wall Street Journal, November 1, 2000, B1;Carol Cruzan Morton, Company, Researchers Battle over Data Access, Science,November 10, 2000, 1063. , .

(22) Birch and Cohn, Of Patients and Profits.(23) Prozac

FDA, . Irving Kirsch andThomas J. Moore, The Emperors New Drugs: An Analysis of Antidepressant Medica-tion Data Submitted to the U.S. Food and Drug Administration, Prevention & Treat-ment, July 15, 2002.

(24) Wayne Kondro and Barbara Sibbald, Drug Company Experts AdvisedStaff to Withhold Data About SSRI Use in Children, Canadian Medical Association

(3) Winslow and Hensley, Study Questions High-Cost Drugs.(4) Altman, Older Way.(5) Families USA, Bitter Pill: The Rising Prices of Prescription Drugs for Older Americans,

June 2002 (www.familiesusa.org).(6) Winslow and Hensley, Study Questions High-Cost Drugs.(7) Altman, Older Way.(8) Lindon M. H. Wing et al., A Comparison of Outcomes with Angiotensin-Converting-

Enzyme Inhibitors and Diuretics for Hypertension in the Elderly, New England Journalof Medicine, February 13, 2003,583.

(9) Harvard Medical School , . , Liz Kowalczys : Beth Israel Seeks Deal with DrugCompany, Boston Globe, February 14, 2001, A1; Harvard to Use Caution with Merck,Boston Globe, August 1, 2001,A1; Lucrative Licensing Deals with Drug, Biotech FirmsAre Raising Ethics Issues for Hospitals, Boston Globe, March 24, 2002, C1. Raja Mishra, Harvard May Ease Rules on Faculty Ties to Drug Firms,Boston Globe, June 9, 2003, A1. Millennium Partners.

(10) Justin E. Bekelman et al., Scope and Impact of Financial Conflicts of Interest inBiomedical Research, Journal of the American Medical Association, January 22-29,2003, 454.

(11) Kevin A. Schulman et al., A National Survey of Provisions in Clinical Trial AgreementsBetween Medical Schools and Industry Sponsors, New England Journal of Medicine,October 24, 2002, 1335.

(12) Alison Bass, Drug Companies Enrich Brown Professor, Boston Globe,October 4, 1999, A1; Douglas M. Birch and Gary Cohn, Of Patients andProfits: Standing Up to Industry, Baltimore Sun, June 26, 2001, A1.

(13) David Willman, Stealth Merger: Drug Companies and Government Medical Research,Los Angeles Times, December 7, 2003, A1.

(14) Subverting U.S. Health editorial, Los Angeles Times, December 7, 2003, M4.(15) ,

Thomas Bodenheimer, Uneasy Alliance: Clinical Investigators and the PharmaceuticalIndustry, New England Journal of Medicine, May 18, 2000, 1539.

123

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124 125

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.(6) (Lauren Bacall) (Matt Lauer) (Today show) (macular degeneration). (Visudyne) . . .

(National Football League NFL) - (Levitra) (Viagra) . 20 . , (New England Patriots) (Gillette Stadium). (Mike Ditka) (Chicago Bears) 30 (3) - 2004

, - (Rafael Palmeiro) . (NASCAR Circuit). - (AmericasCup race). ., (4) ,

124 125

. . (Morley Safer) 60 , . (WJMK) . , 6 1 . () , - (Walter Cronkite) (CNN) (5) . -

.(6) (Lauren Bacall) (Matt Lauer) (Today show) (macular degeneration). (Visudyne) . . .

(National Football League NFL) - (Levitra) (Viagra) . 20 . , (New England Patriots) (Gillette Stadium). (Mike Ditka) (Chicago Bears) 30 (3) - 2004

, - (Rafael Palmeiro) . (NASCAR Circuit). - (AmericasCup race). ., (4) ,

126 127

35 (). (PhRMA-Pharmaceuti-cal Research and Manufacturers of America) , (8) , . .. 2545 , 31 . , ( ). . .. 2544 36 5 5 (9) , .. 2543 35

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142 143

(1) , Tyler Chin, Drug Firms Score by Playing Doctors for Time, American MedicalNews, May 6 2002, 1 (www.amednews.com); Scott Hensley, As Drug-Sales TeamsMultiply, Doctors Start to Tune Them Out, Wall Street Journal, June 13, 2003, A1.

(2) .. 2002, . U.S. General Accounting Office, PrescriptionDrugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations, October2002, GAO-03-177 (www.gao.gov).

(3) Christopher Rowland, Pats Ink Levitra Marketing Deal, Boston Globe, September 12,2003, D1.

(4) Rowland, Pats Ink Levitra Deal.(5) Melody Petersen, A Respected Face, but Is It New or an Ad? New York Times, May

7, 2003, B1; Reuters, Film Production Company Sues Cronkite, New York Times,September 20, 2003, B4.

(6) Lauran Bacall , Melody Petersen, HeartfeltAdvice, Hefty Fees, New York Times, August 11, 2002, C1; Alex Kuczynski, TreatingDisease with a Famous Face, New York Times, December 15, 2002, section 9, 1;Lawrence Goodman, Celebrity Pill Pushers, Salon.com, July 11, 2002.

(7) Petersen, Respected Face.(8) Arnold S. Relman and Marcia Angell, Americas Other Drug Problem, New Repub-

lic, December 16, 2002, 27. .. 1990 .. 2000 35 , ; Henry J. Kaiser Family Foundation, Prescription Drug Trends, Novem-ber 2001 (www.kff.org). ..2002, Public Citizen Congress Watch, Drug Industry Profits: Hefty PharmaceuticalCompany Margins Dwarf Other Industries, June 2003 (www.citizen.org).

(9) , ; , www.novartis.com.

(10) Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Pro-file 2002 (www.Phrma.org).

(11) , PhRMA, Pharmaceutical IndustryProfile 2002, 95 (www.phrma.org).

. . ( -) . -. . - , .

19,100 .. 2544 . 35,000 -. . . - . .

142 143

(1) , Tyler Chin, Drug Firms Score by Playing Doctors for Time, American MedicalNews, May 6 2002, 1 (www.amednews.com); Scott Hensley, As Drug-Sales TeamsMultiply, Doctors Start to Tune Them Out, Wall Street Journal, June 13, 2003, A1.

(2) .. 2002, . U.S. General Accounting Office, PrescriptionDrugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations, October2002, GAO-03-177 (www.gao.gov).

(3) Christopher Rowland, Pats Ink Levitra Marketing Deal, Boston Globe, September 12,2003, D1.

(4) Rowland, Pats Ink Levitra Deal.(5) Melody Petersen, A Respected Face, but Is It New or an Ad? New York Times, May

7, 2003, B1; Reuters, Film Production Company Sues Cronkite, New York Times,September 20, 2003, B4.

(6) Lauran Bacall , Melody Petersen, HeartfeltAdvice, Hefty Fees, New York Times, August 11, 2002, C1; Alex Kuczynski, TreatingDisease with a Famous Face, New York Times, December 15, 2002, section 9, 1;Lawrence Goodman, Celebrity Pill Pushers, Salon.com, July 11, 2002.

(7) Petersen, Respected Face.(8) Arnold S. Relman and Marcia Angell, Americas Other Drug Problem, New Repub-

lic, December 16, 2002, 27. .. 1990 .. 2000 35 , ; Henry J. Kaiser Family Foundation, Prescription Drug Trends, Novem-ber 2001 (www.kff.org). ..2002, Public Citizen Congress Watch, Drug Industry Profits: Hefty PharmaceuticalCompany Margins Dwarf Other Industries, June 2003 (www.citizen.org).

(9) , ; , www.novartis.com.

(10) Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Pro-file 2002 (www.Phrma.org).

(11) , PhRMA, Pharmaceutical IndustryProfile 2002, 95 (www.phrma.org).

. . ( -) . -. . - , .

19,100 .. 2544 . 35,000 -. . . - . .

144 145

Gifts to Physicians from Industry, addendum 2, opinion 8.061, December 2000. De-partment of Health and Human Services, Office of the Inspector General, ComplianceProgram Guidance for Pharmaceutical Manufacturers, April 18, 2003 (http://oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac.pdgf), Federal Register, Vol. 68,no.86 (May 5, 2003), 23738. Robert Pear, Drug Industry Is Told to Stop Gifts toDoctors, New York Times, October 1, 2002, A23.

(26) Liz Kowalczyk, Drug Companies Secret Reports Outrage Doctors, Boston Globe,May 25, 2003, A1.

(27) TAP/Lupron Pharmaceu-tical Regulatory and Compliance Congress and Best Practices Forum in Washington,D.C., November 12-14, 2003, Michael Loucks, Chief of the HealthCare Fraud Unit, Assistant U.S. Attorney, U.S. Attorneys Office for the District ofMassachusetts, Dr. Joseph Gerstein. , Alice Dembner,Drug Firm to Pay $875M Fine for Fraud, Boston Globe, October 4, 2001, A1; AliceDembner, $840M Penalty Is Expected for Drug Company, Boston Globe,May 28,2001,A1; Bruce Japsen, Doctors Outrage Stings TAP, Chicago Tribune, October7,2001,C1; Anne Barnard, Ailing Hospitals, Pharmaceutical Deals, Ethics Put to Test,Boston Globe, November 23, 2002, B1; Shelley Murphy, Drug Sale Said Tied to Favorsat Lahey, Boston Globe, November 9, 2002, A1.

(12) U.S. GAO Prescription Drugs; Robert Pear, Investigators Find RepeatedDeception in Ads for Drugs, New York Times, December 4, 2002, A22.

(13) U.S. GAO, Prescription Drugs, 3.(14) Pear, Investigators Find Repeated Deception.(15) , Francis B. Palumbo and C. Daniel Mullins, The Development of

Direct-to-Consumer Prescription Drug Advertising Regulation, Food and Drug Law Journal,vol. 57, no.3 (2002), 423. , U.S. GAO, Prescription Drugs.

(16) , Meredith B. Rosenthal et al., Deman Effects of Recent Changesin Prescription Drug Promotion, Henry J. Kaiser Family Foundation, June 2003(www.kff.org); Meredith B.Rosenthal et al., Promotion of Prescription Drugs toConsumers, New England Journal of Medicine, February 14, 2002, 498; U.S. GAO,Prescription Drugs; Pear, Investigators Find Repeated Deception; Vanessa Fuhrmansand Gautam Nail, In Europe, Prescription-Drug Ads Are Banned-and Health CostsLower, Wall Street Journal, March 15, 2002, B1.

(17) Chris Adams, FDA Inundated Trying to Assess Drug Ad Pitches, Wall Street Journal,March 14, 2002, B1.

(18) . , Melody Petersen, Whos Minding the Drugstore? New York Times, June29, 2003, section 3, 1; Alice Dembner, FDA Action on Drug Ads Declining, BostonGlobe, October 19, 2002, A1; Michael Kranish, FDA Counsels Rise Embodies U.S.Shift, Boston Globe, December 22, 2002, A1.

(19) U.S. GAO, Prescription Drugs, 21.(20) Alan F. Holmer, Direct-to-Consumer Advertising-Strengthening Our Health Care

System, New England Journal of Medicine, February 14, 2002, 526.(21) Katharine Greider, The Big Fix: How the Pharmaceutical Industry Rips Off American

Consumers (Cambridge, Mass.: Perseus Books, 2003).(22) Chin, Drug Firms Score by Paying Doctors for Time.(23) Liz Kowalczyk, Drug Firms Increasingly Barred from Exam Rooms, Boston Globe, July

28, 2003, A1.(24) Drugmakers Gifts to Doctors Finally Get Needed Scrutiny, editorial, USA Today,

October 14, 2002, 14A.(25) American Medical Association Council on Ethical and Judicial Affairs, Clarification of

144 145

Gifts to Physicians from Industry, addendum 2, opinion 8.061, December 2000. De-partment of Health and Human Services, Office of the Inspector General, ComplianceProgram Guidance for Pharmaceutical Manufacturers, April 18, 2003 (http://oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac.pdgf), Federal Register, Vol. 68,no.86 (May 5, 2003), 23738. Robert Pear, Drug Industry Is Told to Stop Gifts toDoctors, New York Times, October 1, 2002, A23.

(26) Liz Kowalczyk, Drug Companies Secret Reports Outrage Doctors, Boston Globe,May 25, 2003, A1.

(27) TAP/Lupron Pharmaceu-tical Regulatory and Compliance Congress and Best Practices Forum in Washington,D.C., November 12-14, 2003, Michael Loucks, Chief of the HealthCare Fraud Unit, Assistant U.S. Attorney, U.S. Attorneys Office for the District ofMassachusetts, Dr. Joseph Gerstein. , Alice Dembner,Drug Firm to Pay $875M Fine for Fraud, Boston Globe, October 4, 2001, A1; AliceDembner, $840M Penalty Is Expected for Drug Company, Boston Globe,May 28,2001,A1; Bruce Japsen, Doctors Outrage Stings TAP, Chicago Tribune, October7,2001,C1; Anne Barnard, Ailing Hospitals, Pharmaceutical Deals, Ethics Put to Test,Boston Globe, November 23, 2002, B1; Shelley Murphy, Drug Sale Said Tied to Favorsat Lahey, Boston Globe, November 9, 2002, A1.

(12) U.S. GAO Prescription Drugs; Robert Pear, Investigators Find RepeatedDeception in Ads for Drugs, New York Times, December 4, 2002, A22.

(13) U.S. GAO, Prescription Drugs, 3.(14) Pear, Investigators Find Repeated Deception.(15) , Francis B. Palumbo and C. Daniel Mullins, The Development of

Direct-to-Consumer Prescription Drug Advertising Regulation, Food and Drug Law Journal,vol. 57, no.3 (2002), 423. , U.S. GAO, Prescription Drugs.

(16) , Meredith B. Rosenthal et al., Deman Effects of Recent Changesin Prescription Drug Promotion, Henry J. Kaiser Family Foundation, June 2003(www.kff.org); Meredith B.Rosenthal et al., Promotion of Prescription Drugs toConsumers, New England Journal of Medicine, February 14, 2002, 498; U.S. GAO,Prescription Drugs; Pear, Investigators Find Repeated Deception; Vanessa Fuhrmansand Gautam Nail, In Europe, Prescription-Drug Ads Are Banned-and Health CostsLower, Wall Street Journal, March 15, 2002, B1.

(17) Chris Adams, FDA Inundated Trying to Assess Drug Ad Pitches, Wall Street Journal,March 14, 2002, B1.

(18) . , Melody Petersen, Whos Minding the Drugstore? New York Times, June29, 2003, section 3, 1; Alice Dembner, FDA Action on Drug Ads Declining, BostonGlobe, October 19, 2002, A1; Michael Kranish, FDA Counsels Rise Embodies U.S.Shift, Boston Globe, December 22, 2002, A1.

(19) U.S. GAO, Prescription Drugs, 21.(20) Alan F. Holmer, Direct-to-Consumer Advertising-Strengthening Our Health Care

System, New England Journal of Medicine, February 14, 2002, 526.(21) Katharine Greider, The Big Fix: How the Pharmaceutical Industry Rips Off American

Consumers (Cambridge, Mass.: Perseus Books, 2003).(22) Chin, Drug Firms Score by Paying Doctors for Time.(23) Liz Kowalczyk, Drug Firms Increasingly Barred from Exam Rooms, Boston Globe, July

28, 2003, A1.(24) Drugmakers Gifts to Doctors Finally Get Needed Scrutiny, editorial, USA Today,

October 14, 2002, 14A.(25) American Medical Association Council on Ethical and Judicial Affairs, Clarification of

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