1. Amgen Inc., 10-K (2002) filing with the Securities and Exchange Commission, Mar. 10, 2003. Amgen’s profits were calculated by subtracting the $2.99-billion in-process research-and-development write-off for its acquisition of Immunex Inc. from its 2002 aftertax net operating loss of $1.39 billion.
2. Interview with Mark Brand, Sept. 10, 2001.
3. Amgen press release, “FDA Approves Amgen’s Aranesp for Anemia Associated with Chronic Renal Failure,” Sept. 18, 2001, http://www.amgen.com/news/news01/pressrelease010918.html (accessed Oct. 15, 2003).
4. Georgetown University Center on an Aging Society, “Prescription Drugs, a Vital Component of Health Care,” Data Profile no. 5, Sept. 2002; Henry J. Kaiser Family Foundation, “The Medicare Program, Medicare and Prescription Drugs,” Oct. 2002. Dozens of news accounts featured the impact on the elderly of rising drug costs; see, for instance, Peter Jennings, “Bitter Medicine,” ABC-World News Tonight, May 29, 2002.
5. The latest data from the Center for Responsive Politics Web site. See http://www.opensecrets.org (accessed Oct. 10, 2003).
6. Alan F. Holmer, prepared testimony, Senate Finance Committee, Mar. 22, 2000.
7. Alfonso Gambardella, Science and Innovation: The U.S. Pharmaceutical Industry During the 1980s, p. 14.
8. Merck Annual Report, chairman’s message, 2002, http://www.merck.com/finance/annualreport/ar2002/chairmans_message.html (accessed Oct. 15, 2003).
9. Jürgen Drews, In Quest of Tomorrow’s Medicines: An Eminent Scientist Talks about the Pharmaceutical Industry, Biotechnology, and the Future of Drug Research, p. 20.
1. This and subsequent comments are from various interviews with Eugene Goldwasser conducted between 1999 and 2002.
2. The updated version of Goodman and Gilman’s The Pharmacological Basis of Therapeutics (McGraw Hill, 2001), edited by Gilman’s grandson, is still in print and has been translated into nine languages.
3. James Le Fanu, The Rise and Fall of Modern Medicine, pp. 112–13. See also chapter 7.
4. T. Miyake, C. K. Kung, E. Goldwasser, “Purification of Human Erythropoietin,” Journal of Biological Chemistry, Aug. 10, 1977 [252(15)], 5558–64.
5. Eugene Goldwasser, “Erythropoietin: A Somewhat Personal History,” Perspective in Biology and Medicine 40 (fall 1996): 18–32 (quote on p. 25).
6. Martin Kenney, Biotechnology: The University-Industrial Complex, p. 23.
7. Oral history with Niels Reimers, Bancroft Library, University of California at Berkeley, May 8, 1997.
8. Sandra Panem, The Interferon Crusade, p. 72.
9. Interview with George Rathmann, May 27, 2000.
10. Interview with Fu-Kuen Lin, July 25, 2000.
11. A detailed chronology of both Amgen’s and Genetics Institute’s search for the Epo gene is contained in Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., and Genetics Institute, Inc., U.S. District Court for the District of Massachusetts, decided Dec. 11, 1989.
12. Ibid., p. 12.
13. Interview with Daniel Vapnek, Sept. 26, 2001.
14. Biotechnology News, July 21, 1995.
15. Lin interview. Victor Cohn, “Revolutionary Gene Transfer Is Achieved,” Washington Post, Apr. 11, 1980.
16. Amgen v. Chugai and Genetics Institute, p. 12.
17. William Rob Carlson, “Erythropoietin: The Development of a Pharmaceutical Product” (Ph.D. diss., Princeton University, 1988), p. 18. See K. Jacobs et al., “Isolation and Characterization of Genomic and CDNA Clones of Human Erythropoietin,” Nature, Feb. 28, 1985.
18. The Amgen–Genetics Institute case would drag out until mid-1995, when the Supreme Court finally decided not to hear an appeal of the Appeals Court decision in favor of Amgen.
19. J. W. Eschbach et al., “Correction of the Anemia of End-stage Renal Disease with Recombinant Human Erythropoietin. Results of a Combined Phase I and II Clinical Trial,” New England Journal of Medicine, Jan. 8, 1987.
20. Laura Johannes, “Unsolved Mystery: Cystic Fibrosis Gave Up Its Gene Twelve Years Ago: Where’s the Cure?” Wall Street Journal, June 11, 2001.
21. Le Fanu, The Rise and Fall of Modern Medicine, p. 259.
22. Andrew C. Revkin, “Firm May Have Found Key to Treating Anemia; Rare Hormone Holds Promise for Kidney Ills,” New York Times, Jan. 22, 1987.
23. House Ways and Means Committee, Hearing on Health Care Costs, 102nd Cong., 1st sess., Oct. 10, 1991.
24. Interview with Howard Grossman, Dec. 18, 2001. I interviewed Grossman during his presentation at the forty-first Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in Chicago.
25. Interview with Daniel Vapnek, Sept. 21, 2001. By the end of the 1990s, Amgen was repurchasing nearly $1 billion a year of its own stock, according to its 1999 10-K filing with the Securities and Exchange Commission.
26. Barry Stavro, “Amgen Faces Weighty Task with Fat-Reduction Drug,” Los Angeles Times, Sept. 5, 1995.
27. Biotechnology News, Aug. 18, 1995.
28. Gina Kolata, “Hormone That Slimmed Fat Mice Disappoints as Panacea in People,” New York Times, Oct. 27, 1999.
29. See John H. Klippel, “Biologic Therapy for Rheumatoid Arthritis,” New England Journal of Medicine, Nov. 30, 2000. See also J. M. Bathon et al., “A Comparison of Etanercept and Methotrexate in Patients with Early Rheumatoid Arthritis,” New England Journal of Medicine, Nov. 30, 2000; Larry Schuster, “Prescribing Pain Fighters Proving Big Headache for Joint Docs,” Biotechnology Newswatch, Dec. 3, 2001; and Andrew Pollack, “Amgen Buys Biotech Rival Immunex for $16 Billion,” New York Times, Dec. 17, 2001.
30. Klippel, “Biologic Therapy,” Nov. 30, 2000.
31. Interview with Doyt Conn, May 23, 2002.
32. Garabed Eknoyan, professor of medicine at Baylor University and cochair of the National Kidney Foundation’s Dialysis Outcomes Quality Initiative (DOQI), lists himself as a paid consultant to Amgen at continuing medical education seminars where he teaches; Allen Nissenson, a professor of medicine at UCLA and a member of DOQI, is on the company’s advisory board. A full account of this issue can be found in Merrill Goozner, “The Making of a Star Drug,” Chicago Tribune, May 24, 1999.
33. Interview with Allen Nissenson, Feb. 15, 1999.
34. Rhonda L. Rundle and Laura Johannes, “Ruling Against Transkaryotic Therapies Saves Amgen’s Monopoly on Anemia Drug,” Wall Street Journal, Jan. 22, 2001.
1. Vannevar Bush, Science, the Endless Frontier: A Report to the President (Washington, D.C.: U.S. Government Printing Office, 1945).
2. A good example of that reasoning can be found in Jerome Groopman, “The Thirty Years’ War: Have We Been Fighting Cancer the Wrong Way?” New Yorker, June 4, 2001. For more on the war on cancer, see chapter 7.
3. Daniel S. Greenberg, Science, Money, and Politics: Political Triumph and Ethical Erosion, p. 419.
4. Interview with John Barranger, Mar. 28, 2002.
5. This and subsequent comments from Roscoe Brady were gleaned from numerous interviews conducted during 2000, 2001, and 2002.
6. Office of Technology Assessment, Federal and Private Roles in the Development and Provision of Alglucerase Therapy for Gaucher Disease, Washington, D.C., 1992.
7. Brady interviews.
8. See Office of Technology Assessment, Federal and Private Roles, pp. 1–2.
9. Interview with Ernest Beutler, Mar. 15, 2002. Beutler is a thorn in Genzyme’s side since he is the chief U.S. proponent of the idea that low doses of enzyme are just as effective as Genzyme’s recommended higher doses in treating Gaucher disease (see the discussion of price below).
10. Interview with John Barranger, Mar. 28, 2002. Of course, Amgen, where Fu-Kuen Lin was finishing his work at about the same time, did patent their gene’s use for the expression of erythropoietin (see chapter 1).
11. Interview with Robin Ely Berman, June 13, 2002.
12. Brady interviews.
13. Carolyn H. Asbury, Orphan Drugs, Medical versus Market Value, p. 111.
14. Interview with Marlene Haffner, Apr. 12, 2002.
15. Office of Technology Assessment, Federal and Private Roles, p. 2.
16. Interview with Abby Meyers, Oct. 18, 2001.
17. Congressional Record, Apr. 1, 1993, vol. 138, no. 44, p. 1851.
18. Nancy Kassebaum and Howard Metzenbaum, “Wonder Drugs and Scare Talk,” Washington Post, June 23, 1992.
19. Henri A. Termeer, “Pricing: The Cost of Miracles,” Wall Street Journal, Nov. 16, 1993.
20. Patent and Trademark Office, Patent no. 5,236,838, granted Aug. 17, 1993. Office of Technology Assessment, “Federal and Private Roles,” p. 13.
21. Interview with Roscoe Brady, June 6, 2002.
22. A list of orphan drugs, both those still under investigation and those approved, is available on the Web site of the Food and Drug Administration’s Office of Orphan Products Development, http://www.fda.gov/orphan/designat/list.html (accessed Oct. 15, 2003).
23. Meyers interview.
24. Interview with David Calhoun, Mar. 16, 2002.
25. D. H. Calhoun et al., “Fabry Disease: Isolation of a CDNA Clone Encoding Human Alpha-Galactosidase A,” Proceedings of the National Academy of Science (Nov. 1985): 7364–68.
26. Interview with Yiannis Ioannou, Mar. 25, 2002.
27. Patent and Trademark Office, Patent no. 5,356,804, granted Oct. 18, 1994.
28. FDA, Office of Orphan Products Development, Web site, http://www.fda.gov/orphan/designat/list.html (accessed Oct. 15, 2003).
29. Interview with Jack Johnson, president of the Fabry Information and Support Group, Feb. 27, 2002.
30. Interview with Frank Landsberger, June 4, 2002.
31. E-mail communication from Lowell Weiner, assistant vice president for public relations at Wyeth, which now owns Genetics Institute, June 4, 2002.
32. Interview with Richard Selden, Apr. 4, 2002.
33. Ioannou interview.
34. Selden interview.
35. Ibid.
36. Transkaryotic Therapies Inc. (TKT), initial registration statement with the Securities and Exchange Commission, Aug. 27, 1996.
37. Genzyme Corp., 10-K (1993–2001) filings with the Securities and Exchange Commission.
38. Raphael Schiffmann et al., “Enzyme Replacement Therapy in Fabry Disease,” Journal of the American Medical Association, June 6, 2001; Christine M. Eng et al., “Safety and Efficacy of Recombinant Human a-Galactosidase: A Replacement Therapy in Fabry’s Disease,” New England Journal of Medicine, July 5, 2001.
39. Interview with Gregory Pastores, Mar. 27, 2002.
40. Genzyme Corp., 10-K (2001) filing with the Securities and Exchange Commission, Apr. 1, 2002.
41. Interview with Michael Russo, June 20, 2002.
42. Ibid.
43. Interview with Raphael Schiffmann, Jan. 14, 2003.
44. Otesa Middleton, “FDA Says Serono’s Rebif Approval a Rare Case,” Dow Jones Newswires, Mar. 8, 2002.
1. “Reading the Book of Life: White House Remarks on Decoding of Genome,” New York Times, June 27, 2000.
2. Richard Preston, “The Genome Warrior,” New Yorker, June 12, 2000, p. 66.
3. New York Times transcript of President Bill Clinton’s press conference, June 27, 2000.
4. Kevin Davies, Cracking the Genome, p. 238.
5. Press conference, Capitol Hilton Hotel, Washington, D.C., June 26, 2000.
6. Thomas D. Kiley, “Patents on Random Complementary DNA Fragments?” Science, Aug. 14, 1992, p. 915.
7. Ibid.
8. Hearing of the House Judiciary Subcommittee on Courts and Intellectual Property, 106th Cong., 2nd. sess., July 13, 2000.
9. Press conference, June 26, 2000.
10. Davies, Cracking the Genome, p. 207.
11. Paul Jacobs and Aaron Zitner, “Genome Milestone: Cracking the Code,” Los Angeles Times, June 27, 2000.
12. Cook-Deegan, The Gene Wars, p. 61. Cook-Deegan is quoting from F. Sanger, “Sequences, Sequences, and Sequences,” Annual Review of Biochemistry 57 (1988): 1–28.
13. Ibid. (The Gene Wars), pp. 64–67.
14. Peter G. Gosselin and Paul Jacobs, “U.S. Officials Probe Cost of Genetic Decoder,” Los Angeles Times, Feb. 16, 2000.
15. Cook-Deegan, The Gene Wars, p. 66.
16. David Fishlock, “How Applied Biosystems Produces Biotechnology Tools,” Financial Times (London), Aug. 22, 1983, p. 5.
17. Huang was never included on the patent, which became a subject of litigation nineteen years later. MJ Research, which wanted to build a competitor machine using the technology, filed a qui tam suit against Applied Biosystems alleging it had overcharged the government for the machines. Michael Barbaro, “Patent Fight Erupts over Gene Machine,” Washington Post, July 15, 2002.
18. Gosselin and Jacobs, “U.S. Officials Probe Cost of Genetic Decoder,” Los Angeles Times, Feb. 16, 2000.
19. Cook-Deegan, The Gene Wars, p. 88.
20. Interview with Marvin Stodolsky, Aug. 24, 2000.
21. Interview with Lloyd Smith, Oct. 16, 2000.
22. Interview with Joseph Jaklevic, Jan. 26, 2002.
23. Ibid.
24. Interview with Richard Mathies, Sept. 15, 2000
25. Interview with Jingyue Ju, Oct. 15, 2000
26. Interview with Roy Whitfield, Oct. 16, 2000.
27. Interview with Mike Hunkapillar, July 9, 2002.
28. Nicholas Wade, “Scientist’s Plan: Map All DNA within Three Years,” New York Times, May 10, 1998.
29. Preston, “The Genome Warrior,” p. 75.
30. Quoted in Davies, Cracking the Genome, pp. 91–92.
31. Interview with John Doll, July 3, 2002. My statistic of 1,300 patents comes from Doll’s remarks.
32. Quoted in Tom Bethell, “A Map to Nowhere,” American Spectator, Apr. 2001.
33. David P. Hamilton, “Myriad Genetics Unveils a Project to Catalog Every Protein in Humans,” Wall Street Journal, Apr. 4, 2001.
34. Interview with Helen Berman, director of the Protein Data Bank, department of chemistry, Rutgers University, July 8, 2002.
35. Rebecca S. Eisenberg, “The Shifting Functional Balance of Patents and Drug Regulation,” Health Affairs, Sept./Oct. 2001, p. 127.
36. Ibid.
37. Peg Brickley, “New Patent Worries Professors,” The Scientist, July 22, 2002, p. 19.
38. Andrew Pollack, “Scientist Quits The Company He Led in Quest For Genome,” New York Times, Jan. 23, 2002.
39. Patent and Trademark Office, U.S. Patent no. 6,410,294.
40. See, for instance, Lawrence K. Altman, “Cancer Doctors See New Era of Optimism,” New York Times, May 22, 2001.
41. Interview with Susan Taylor, July 22, 2002.
1. National Institute for Allergies and Infectious Diseases, update, “Concorde Trial,” Apr. 1, 1993, archived at http://www.aegis.com/news/niaid/1993/CDC93005.html (accessed Oct. 15, 2003).
2. John James, “Berlin Conference Overview,” AIDS Treatment News, June 18, 1993.
3. I thank Jon Cohen, author of Shots in the Dark: The Wayward Search for an AIDS Vaccine, for what I consider to be the best of the many metaphors that have been used to describe the disease.
4. Stephen Fried, “Cocktail Hour,” Washington Post Magazine, May 18, 1997.
5. The Vertex saga was documented in Barry Werth, The Billion-Dollar Molecule: One Company’s Quest for the Perfect Drug. The molecule in the title was not the protease inhibitor but the drug aimed at curbing transplant rejections.
6. Interview with Robert Yarchoan, June 18, 2001.
7. Larry Kramer, “A Good News/Bad News AIDS Joke,” New York Times Magazine, July 14, 1996; Andrew Sullivan, “When Plagues End,” New York Times Magazine, Nov. 10, 1996; Christine Gorman, “The Disease Detective,” Time, Dec. 30, 1996–Jan. 6, 1997.
8. Louis Galambos, “In the AIDS Fight, Big Is Beautiful: Only the Corporate Giants Can Afford the Cost of Innovation,” Washington Post, Dec. 1, 1996.
9. Interview with John Erickson, June 21, 2001.
10. L. H. Pearl and W. R. Taylor, “A Structural Model for Retroviral Proteases,” Nature, Sept. 24, 1987, pp. 351–54.
11. Interview with John McGowan, July 20, 2001.
12. Interview with Dale Kempf, Aug. 23, 2001.
13. Daniel J. Kevles, “The Changed Partnership,” Wilson Quarterly 19 (summer 1995): 40–48.
14. The Discovery and Development of Penicillin, 1928–1945, Alexander Fleming Laboratory Museum (London), Nov. 19, 1999, p. 6.
15. Kenney, Biotechnology, p. 13.
16. Donald E. Stokes, Pasteur’s Quadrant: Basic Science and Technological Innovation, p. 48; see also Kevles, “The Changed Partnership.”
17. Stokes, Pasteur’s Quadrant, p. 49.
18. See Kevles, “The Changed Partnership.”
19. See Stokes, Pasteur’s Quadrant, p. 135.
20. Cohen, Shots in the Dark, p. 179.
21. See, for instance, Groopman, “The Thirty Years’ War” in The New Yorker, June 4, 2001, pp. 52–63; also, John C. Bailar and Heather L. Gornik, “Cancer Undefeated,” New England Journal of Medicine, May 29, 1997, pp. 1569–74.
22. Cohen, Shots in the Dark, p. 6.
23. Peter S. Arno and Karyn L. Feiden, Against the Odds: The Story of AIDS Drug Development, Politics and Profit, pp. 37–46.
24. Letters to the Editor, New York Times, Sept. 28, 1989.
25. Arno and Feiden, Against the Odds, p. 54.
26. Interview with Lawrence Corey, Jan. 10, 2002.
27. John Thomas Mahoney, The Merchants of Life: An Account of the American Pharmaceutical Industry, p. 192. Frank Ryan, The Forgotten Plague: How the Battle Against Tuberculosis Was Won and Lost, p. 339.
28. Scolnick quoted in Louis Galambos and Jane Eliot Sewell, Confronting AIDS, The Business History Group and Johns Hopkins University, published by Merck Research Laboratories (undated), p. 8.
29. Galambos and Sewell, Confronting AIDS, pp. 16–17. Interview with Manuel Navia, June 15, 2001.
30. Michael Waldholz, “AIDS—The Race for a Cure—Tracking a Killer,” Wall Street Journal, Feb. 16, 1989. See also Werth, Billion-Dollar Molecule, p. 32; and Navia interview.
31. Interview with Emilio Emini, Merck Research Labs, West Point, Pennsylvania, Nov. 8, 2001.
32. Werth, Billion-Dollar Molecule, p. 110.
33. Interview with Alexander Wlodawer, June 28, 2001.
34. Galambos and Sewell, Confronting AIDS, p. 20.
35. Mahoney, Merchants of Life, pp. 222–26.
36. Panem, The Interferon Crusade, p. 74.
37. Interview with Whaijen Soo, Aug. 14, 2001.
38. Ibid. Interview with Keith Bragman, July 6, 2001.
39. M. A. Navia et al., “Three-Dimensional Structure of Aspartyl Protease from Human Immunodeficiency Virus HIV-1,” Nature, Feb. 16, 1989, pp. 615–20.
40. Interview with Noel Roberts, Aug. 8, 2001.
41. Ibid.
42. Ibid.
43. Interview with Miklos Salgo, Apr. 13, 2001.
44. Ibid., Aug. 8, 2001.
45. Drews, In Quest of Tomorrow’s Medicines, pp. 15–16.
46. Ibid., p. 16.
47. Bragman interview.
48. Drews, In Quest of Tomorrow’s Medicines, p. 16.
1. Mahoney, Merchants of Life, pp. 129–42. See also The Discovery and Development of Penicillin, p. 6.
2. Julia Flynn Siler, “The Slipper Ladder at Abbott Labs,” Business Week, Oct. 30, 1989.
3. See “Ferid Murad—Autobiography” on the Nobel Committee Web site: http://www.nobel.se/medicine/laureates/1998/murad-autobio.html (accessed Oct. 15, 2003).
4. Interview with Ferid Murad, Jan. 4, 2002.
5. Interview with Dale Kempf, Aug. 23, 2001.
6. Interview with John Erickson, July 13, 2001.
7. Interview with Dan Hoth, Sept. 6, 2001.
8. John Schwartz and John McCormick, “The CEO Who Won’t Go,” Business Week, May 7, 1990; Erickson and Murad interviews.
9. Susan Okie, “Scientists Return to NCI’s Cutting Edge,” Washington Post, July 27, 1990.
10. “AIDS Protesters Picket Pharmaceutical Firm,” San Francisco Chronicle, Mar. 7, 1991. John James, “Clarithromycin: Accessible or Not?” AIDS Treatment News, Oct. 18, 1991; Kempf and John Leonard (Jul. 16, 2001) interviews.
11. Hoth interview.
12. Letter from Andre Pernet to Bruce Chabner, Dec. 19, 1991, obtained by Freedom of Information Act (FOIA) request. FOIA officials at the National Institute of Infectious Diseases said a similar correspondence between director Anthony Fauci and Pernet no longer exists.
13. For a comprehensive history of government policy toward intellectual property developed by the public sector, see Rebecca S. Eisenberg, “Public Research and Private Development: Patents and Technology Transfer in Government-Sponsored Research,” Virginia Law Review 82 (Nov. 1996): 1663–1726.
14. For a complete discussion of the Bayh-Dole Act and its implications, see Peter S. Arno and Michael H. Davis, “Why Don’t We Enforce Existing Drug Price Controls? The Unrecognized and Unenforced Reasonable Pricing Requirements Imposed upon Patents Deriving in Whole or in Part from Federally Funded Research,” Tulane Law Review 75, no. 3 (2001): 631–93. See also Baruch Brody, “Public Goods and Fair Prices: Balancing Technological Innovation with Social Well-being,” The Hastings Center Report 26 (Mar./Apr. 1996): 5–11.
15. Kenney, Biotechnology, p. 100.
16. Government Accounting Office, “Technology Transfer: Number and Characteristics of Inventions Licensed by Six Federal Agencies,” June 1999.
17. Letter from Bruce Chabner to Andre Pernet, Jan. 7, 1992.
18. Interview with John Leonard, July 1, 2001.
19. Letter from Bruce Chabner to John Leonard, May 13, 1992.
20. Letter from John Leonard to Bruce Chabner, June 2, 1992 (the company nomenclature for the drug, A-77003, was redacted from the National Cancer Institute (NCI) response to my FOIA request). Also Hoth, Chabner, and Leonard interviews.
21. Hoth interview.
22. Hiroaki Mitsuya et al., “Targeted Therapy of Human Immunodeficiency Virus-Related Disease,” Journal of the Federation of American Societies for Experimental Biology 10 (July 1991): 2369–81
23. Interview with Emilio Emini, Nov. 8, 2001.
24. AIDS Treatment News, Nov. 22, 1991.
25. Emini interview.
26. See, for instance, Marilyn Chase, “Merck Setback Shows Problems with AIDS Drugs,” Wall Street Journal, Nov. 26, 1991.
27. Erickson interview, Mar. 2, 2002.
28. Scolnick quoted in Galambos and Sewell, Confronting AIDS, p. 35.
29. Emini interview.
30. Yung-Kang Chow et al., “Use of Evolutionary Limitations of HIV-1 Multidrug Resistance to Optimize Therapy,” Nature, Feb. 18, 1993, 650–54.
31. Jean-Pierre Aboulker and Ann Marie Swart, “Preliminary Analysis of the Concorde Trial” (letters to the editor), Lancet, Apr. 13, 1993, 889–90.
32. Steven Epstein, Impure Science: AIDS, Activism, and the Politics of Knowledge, p. 308.
33. Lawrence K. Altman, “Faith in Multiple-Drug AIDS Trial Shaken by Report of Error in Lab,” New York Times, July 27, 1993.
34. Ibid.
1. These dates comes from NIH Grant Number 5U01A1027220-05 and U.S. Patent no. 5,343,866.
2. Interview with David Ho, Sept. 20, 2001.
3. D. D. Ho, et al., “Antibody to Lymphadenopathy-Associated Virus in AIDS,” letter to New England Journal of Medicine, Mar. 7, 1985, pp. 649–50.
4. Ho interview.
5. Interview with Alan Perelson, Feb. 7, 2002.
6. Ho interview.
7. John S. James, “DDC/AZT Combination: Promising Early Results,” AIDS Treatment News, Nov. 23, 1990.
8. A complete discussion of the AIDS surrogate marker issue is contained in Epstein, Impure Science, pp. 265–94.
9. Mark Harrington, Ten Texts on Saquinavir: Its Rapid Rise and Fall, June 16, 2001, Treatment Access Group, http://www.aidsinfonyc.org/tag/tx/saquinavirten.html (accessed Oct. 13, 2003).
10. Interview with Ann Collier, June 29, 2001.
11. Letter from Treatment Access Group, Gay Men’s Health Crisis, AIDS Action Council, and AIDS Action Baltimore to David Kessler, June 16, 1994.
12. Warren E. Leary, “U.S. Gives Up Right to Control Drug Prices,” New York Times, Apr. 12, 1995.
13. “Inside Roche: An Interview with Jürgen Drews and Whaijen Soo,” Gay Men’s Health Crisis’ Treatment Issues, Dec. 1994.
14. Marlene Cimons and Thomas H. Maugh II, “New Drugs Offer Hope in Battle Against AIDS,” Los Angeles Times, Feb. 1, 1995.
15. Henry E. Chang, “Conference Looks at HIV Drug Resistance,” Gay Men’s Health Crisis’ Treatment Issues, Sept. 1995; Jules Levin, “Protease Inhibitors and Prevention of Cross Resistance,” AIDS Treatment News, Oct. 6, 1995.
16. Interview with Keith Bragman, July 6, 2001.
17. Examiner’s Report on Invirase (NDA 20-628), submitted to the Antiviral Drugs Advisory Committee, FDA, Nov. 7, 1995, p. 105. Transcript obtained through FOIA request, Apr. 5, 2002.
18. Pricing information obtained from the Cipla Web site: http://www.cipla.com (accessed Oct. 15, 2003).
19. Laurie McGinley, “First of New Class of AIDS Drugs Get FDA Approval,” Wall Street Journal, Dec. 8, 1995.
20. Interview with John Leonard, July 17, 2001.
21. Theo Smart, “More Clinical Data on Protease Inhibitors,” Gay Men’s Health Crisis’ Treatment Issues, Oct. 1995.
22. FDA, New Drug Application 20-659 (Norvir), p. 62. Obtained via FOIA request.
23. “Three Days that Shook the World,” Gay Men’s Health Crisis’ Treatment Issues, Mar. 1996.
24. Galambos and Sewell, Confronting AIDS, p. 41.
25. Michael Waldholz, “Strong Medicine: New Drug ‘Cocktails’ Mark Exciting Turn in the War on AIDS,” Wall Street Journal, June 14, 1996.
26. Galambos and Sewell, Confronting AIDS, p. 42.
27. Michael Waldholz, “Strong Medicine: New Drug Cocktails Mark Exciting Turn in the War on AIDS,” Wall Street Journal, June 14, 1996.
28. Gabriel Torres and Dave Gilden, “Commentary: Studying Protease Inhibitors,” Gay Men’s Health Crisis’ Treatment Issues, Aug. 1994.
29. “Roy Vagelos on AIDS Treatment and Drug Development,” Gay Men’s Health Crisis’ Treatment Issues, Apr. 1994.
30. Galambos and Sewell, Confronting AIDS, p. 50.
31. Ibid., p. 51.
32. Ibid., p. 55n165.
33. Waldholz, “Strong Medicine.”
34. Elyse Tanouye, “Short Supply: Success of AIDS Drug Has Merck Fighting To Keep Up the Pace,” Wall Street Journal, Nov. 5, 1996.
35. Stephen Fried, “Cocktail Hour,” Washington Post Magazine, May 18, 1997, p. 10.
36. The Global Alliance for TB Drug Development, “The Economics of TB Drug Development,” Oct. 2001, p. 3.
37. See Fried, “Cocktail Hour.”
38. Agouron Pharmaceuticals Inc., 10-K (1995, 1997, 1998) filings with the Securities and Exchange Commission.
39. Vertex Pharmaceuticals Inc., 10-K (1992–99) filings with the Securities and Exchange Commission.
40. David Brown, “Study Finds Drug-Resistant HIV in Half of Infected Patients,” Washington Post, Dec. 29, 2001.
41. Thomas H. Maugh II, “AIDS Scientists Fight Rising Tide of Resistance, Risky Behavior,” Los Angeles Times, Feb. 12, 2001.
42. Interviews with Erickson in Aug. 2001 and Mar. 2002 and various e-mail communications.
1. LeAnn D. Andersen et al., “Assessing a Decade of Progress in Cancer Control,” The Oncologist 7 (2002): 200–204; see also Gina Kolata, “Study Sets Off Debate over Mammograms’ Value,” New York Times, Dec. 9, 2001.
2. All data drawn from NCI, SEER Cancer Statistics Review, 1973–99, http://www.seer.cancer.gov/; see also Robert N. Proctor, Cancer Wars: How Politics Shapes What We Know and Don’t Know About Cancer, pp. 17–34.
3. Gina Kolata, “Hope in the Lab: A Special Report. A Cautious Awe Greets Drugs That Eradicate Tumors in Mice,” New York Times, May 3, 1998. As of late 2002, one of EntreMed’s anti-angiogenesis drugs was in Phase II clinical trials for a rare form of pancreatic cancer. The FDA provided financial support for the trial from a special fund set up to promote drugs for rare diseases.
4. Robert Bazell, Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer, p. 25. He attributes the phrase to author Susan Love.
5. Unpublished briefing paper by Edward Sausville, director of the Developmental Therapeutics Program, Division of Cancer Treatment and Diagnosis, NCI.
6. Groopman, “The Thirty Years’ War,” p. 52.
7. Richard A. Rettig, Cancer Crusade, p. 98.
8. James T. Patterson, The Dread Disease: Cancer and Modern American Culture, pp. 88–90.
9. Ibid.
10. Ibid., p. 117.
11. Rettig, Cancer Crusade.
12. Ibid., p. 23; Patterson, The Dread Disease, pp. 130–31.
13. Rettig, Cancer Crusade.
14. Dudley’s role is described in Patterson’s book and in a short entry in the Handbook of Texas Online, Texas State Historical Association, http://www.tsha.utexas.edu/handbook/online/articles/view/JJ/fja44.html (accessed Oct. 15, 2003).
15. Norman Baker of Iowa, advertising that “cancer is curable,” peddled his arsenic compounds through the mails. He eventually served four years in Leavenworth for mail fraud. Harry Hoxsey attracted thousands of dying patients to his Dallas clinic for a treatment that combined potassium iodide, red clover, poke root, prickly ash bark, and other herbal aids. It took the FDA more than two decades of litigation before it shut him down in 1960. The two were only the most famous of dozens of charlatans who “worked the cancer angle” in mid-twentieth-century America. See Patterson, The Dread Disease, pp. 106–8.
16. Bazell, Her-2, pp. 22–23.
17. Jordan Goodman and Vivien Walsh, The Story of Taxol: Nature and Politics in the Pursuit of an Anti-Cancer Drug, pp. 11–12.
18. Patterson, The Dread Disease, pp. 145–47, 195.
19. From a 1964 interview quoted in Patterson, The Dread Disease, p. 196.
20. Saul A. Schepartz, “The National Cancer Institute’s Drug Development Program,” Division of Cancer Treatment and Diagnosis, NCI; reprinted in Cooperative Approaches to Research and Development of Orphan Drugs, ed. Melvin H. Van Woert and Eunyong Chung (New York: Alan R. Liss Inc., 1985), p. 75.
21. Proctor, Cancer Wars, pp. 36–48.
22. Richard Kluger, Ashes to Ashes: America’s Hundred-Year Cigarette War, the Public Health, and the Unabashed Triumph of Philip Morris, pp. 135–62.
23. Kluger, Ashes to Ashes, pp. 143–44.
24. See Kluger for a full history of the scientific battles over cigarette smoking and cancer. For a broader discussion of industry-funded science, see Proctor, Cancer Wars, esp. chapter 5, “ ‘Doubt Is Our Product’: Trade Association Science.”
25. Robert A. Weinberg, Racing to the Beginning of the Road: The Search for the Origin of Cancer, p. 31.
26. Weinberg, Racing to the Beginning of the Road, p. 57.
27. Panem, The Interferon Crusade, p. 12. At the outset of the biotechnology era, NCI funded numerous experiments with private companies seeking to use interferon against various cancers. It eventually found a use against hepatitis C and a few other minor indications, but it proved nowhere near as medically useful as initially expected. To an earlier generation of critics, the interferon experience was proof that government-led industrial policy in drug development was bound to fail.
28. Weinberg, Racing to the Beginning of the Road, p. 73.
29. Rettig, Cancer Crusade, pp. 156, 218.
30. Ibid., pp. 255–56.
31. Proctor, Cancer Wars, p. 137.
32. Ibid., pp. 57–61.
33. Ibid., p. 133.
34. Weinberg, Racing to the Beginning of the Road, pp. 83–84.
35. Interview with Vincent T. De Vita (director of NCI from 1980 to 1988), director of the Yale University Cancer Center, Aug. 12, 2002.
36. Michael Waldholz, Curing Cancer, p. 278.
37. Ibid., p. 43.
38. Ibid., p. 286.
39. Panem, The Interferon Crusade, pp. 35–74.
40. B. Rosenberg et al., “Inhibition of Cell Division in Escherichia Coli by Electrolysis Products from a Platinum Electrode,” Nature, Feb. 13, 1965, pp. 698–99.
41. Arthur Allen, “Triumph of the Cure,” Salon.com, July 29, 1999, http://www.salon.com/health/feature/1999/07/29/lance (Oct. 15, 2003); Lawrence H. Einhorn, “Update in Testicular Cancer” (unpublished paper, Indiana University Medical Center); and “NCI Role in the Discovery and Development of Marketed Anticancer Drugs” (unpublished paper, NCI).
42. Goodman and Walsh, The Story of Taxol, pp. 56–69.
43. P. B. Schiff, J. Fant, S. B. Horwitz, “Promotion of Microtubule Assembly In Vitro by Taxol,” Nature, Feb. 22, 1979, pp. 665–67.
44. Goodman and Walsh, The Story of Taxol, pp. 115–19.
45. Marilyn Chase, “Clashing Priorities: A New Cancer Drug May Extend Lives,” Wall Street Journal, Apr. 9, 1991.
46. Goodman and Walsh, The Story of Taxol, p. 158.
47. Interview with Joseph Rubinfeld, Dec. 3, 2002. Rubinfeld left Bristol-Myers Squibb to help start Amgen. In 2002 he was chief executive officer of SuperGen, which is seeking to commercialize anticancer drugs discovered at the Houston-based Stehlin Foundation, a nonprofit institute that has screened drug candidates for NCI for many years.
48. Hearing of the Regulation, Business Opportunity, and Energy Subcommittee of the House Small Business Committee, 103rd Cong., 1st sess., Jan. 25, 1993.
49. Ibid.
50. Ibid.
51. Peter R. Dolan, “Letter to Employees,” Bristol-Myers Squibb, June 6, 2002, http://www.bms.com (accessed June 15, 2002).
52. Interview with Richard Klausner, July 16, 2002.
53. Pharmaceutical Research and Manufacturers Association, “2001 Survey: New Medicines in Development for Cancer,” http://www.phrma.org/newmedicines/resources/cancer01.pdf (accessed Oct. 15, 2003).
54. Quoted in Groopman, “The Thirty Years’ War,” p. 63.
55. Klausner interview.
56. This account of the development of Herceptin is drawn largely from Bazell, Her-2, pp. 35–52. Also, interview with Dennis Slamon, Feb. 7, 2003.
57. Bazell, Her-2; Slamon interview.
58. See, for instance, Linda Marsa, Prescription for Profits: How the Pharmaceutical Industry Bankrolled the Holy Marriage between Science and Business, pp. 199–207.
59. Charles McCoy, “Genentech’s New CEO Seeks Clean Slate—Levinson Takes Charge at Biotech Firm after Raab’s Ouster,” Wall Street Journal, July 12, 1995.
60. Bazell, Her-2, pp. 44–47
61. Slamon interview.
62. See, for instance, Craig Horowitz, “The Cancer Killer,” New York, May 25, 1998, pp. 67–71.
63. Bazell, Her-2, p. 72.
64. Tara Parker-Pope, “Revlon Is a Cancer Drug’s Unlikely Benefactor,” Wall Street Journal, May 15, 1998.
65. For the trial’s summary, see Herceptin’s label, FDA, http://www.fda.gov/cder/biologics/products/trasgen020900.html (accessed Oct. 15, 2003).
66. Slamon interview.
67. C. L. Vogel et al., “First-Line Herceptin Monotherapy in Metastatic Breast Cancer,” Oncology 61, supp. 2 (2001): 37–42; Slamon interview.
68. Herceptin generated $346.6 million in sales for Genentech in 2001. See Bernadette Tansey, “Judge Rules Against Genentech in Chiron Patent Suit,” San Francisco Chronicle, June 28, 2002.
69. Interview with V. Craig Jordan, Sept. 11, 2002. See also V. Craig Jordan, “Designer Estrogens,” Scientific American, Oct. 1998, pp. 60–67.
70. Gina Kolata and Lawrence M. Fisher, “Drugs to Fight Breast Cancer Near Approval,” New York Times, Sept. 3, 1998.
71. Jordan interview.
72. Nicholas Wade, “Powerful Anti-Cancer Drug Emerges from Basic Biology,” New York Times, May 8, 2001.
73. Jill Waalen, “Gleevec’s Glory Days,” Howard Hughes Medical Institute Bulletin, Dec. 2001, pp. 10–15.
74. Interview with Brian Druker, Jan. 17, 2003.
75. Druker interview. See also Wade, “Powerful Anti-Cancer Drug”; Waalen, “Gleevec’s Glory Days”; and Stephen D. Moore, “Blood Test: News about Leukemia Unexpectedly Puts Novartis on the Spot,” Wall Street Journal, June 6, 2000.
76. Moore, “Blood Test.” See also G. D. Demetri et al., “Efficacy and Safety of Imatinib Mesylate in Advanced Gastrointestinal Stromal Tumors,” New England Journal of Medicine, Aug. 15, 2002, pp. 472–80. The financial disclosure statements in the paper do not include NCI.
77. Brian J. Druker et al., “Efficacy and Safety of a Specific Inhibitor of the BCR-ABL Tyrosine Kinase in Chronic Myeloid Leukemia,” New England Journal of Medicine, Apr. 5, 2001, pp. 1031–37. Also Brian J. Druker et al., “Activity of a Specific Inhibitor of the BCR-ABL Tyrosine Kinase in the Blast Crisis of Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia with the Philadelphia Chromosome,” New England Journal of Medicine, Apr. 5, 2001, pp. 1038–42.
78. Druker interview.
79. “ODAC Advice Poses Challenge to FDA: Would Iressa Approval Erode Standards?” The Cancer Letter, Nov. 8, 2002.
80. “FDA Says Data Insufficient to Evaluate C225 Application,” The Cancer Letter, Jan. 4, 2002.
81. For a detailed account of Erbitux’s early development, see Catherine Arnst, “The Birth of a Cancer Drug,” Business Week, July 9, 2001, pp. 95–102.
82. Ibid.
83. Geeta Anand, “History and Science: In Waksal’s Past: Repeated Ousters,” Wall Street Journal, Sept. 27, 2002.
84. Arnst, “The Birth of a Cancer Drug,” p. 98.
85. Justin Gillis, “A Hospital’s Conflict of Interest: Patients Weren’t Told of Stake in Cancer Drug,” Washington Post, June 30, 2002; “Mendelsohn Defends ImClone’s Actions and His Role in Development of C225,” The Cancer Letter, Oct. 18, 2002, p. 5.
86. The Cancer Letter, Jan. 4, 2002.
87. Ralph W. Moss, “Report from ASCO: Trials and Tribulations of a New Cancer Drug,” Cancer Decisions Newsletter, July 29, 2002.
88. “Mendolsohn Defends ImClone’s Actions,” p. 3.
89. Druker interview.
90. Jordan interview.
91. Interview with Ellen Vitetta, Dec. 12, 2002.
1. The best account I’ve found of the so-called Prontosil affair is contained in Frank Ryan, Forgotten Plague. See esp. pp. 98–120.
2. Milton Silverman and Philip R. Lee, Pills, Profits, and Politics, p. 86.
3. Peter Temin, “Technology, Regulation, and Market Structure in the Modern Pharmaceutical Industry,” Bell Journal of Economics 10, no. 2 (1979): 429–46. See also Jane S. Smith, Patenting the Sun: Polio and the Salk Vaccine.
4. Temin, “Technology, Regulation, and Market Structure,” p. 438.
5. Richard Harris, The Real Voice, p. 8.
6. Ibid., p. 79.
7. Silverman and Lee, Pills, Profits, and Politics, pp. 4–5.
8. Victor R. Fuchs and Harold C. Sox Jr., “Physicians’ Views of the Relative Importance of Thirty Medical Innovations,” Health Affairs 20 (Sept./Oct. 2001): 35.
9. David A. Kessler, Janet L. Rose, Robert J. Temple, Renie Schapiro, and Joseph P. Griffin, “Therapeutic-Class Wars: Drug Promotion in a Competitive Marketplace,” The New England Journal of Medicine, Nov. 17, 1994, pp. 1350–53.
10. NIH, NIH Contributions to Pharmaceutical Development, Case Study Analysis of the Top-Selling Drugs, Office of Science Policy, Feb. 2000.
11. Interview with George Sachs, Mar. 29, 2001.
12. David Blumenthal et al., “Participation of Life-Science Faculty in Research Relationships with Industry,” New England Journal of Medicine, Dec. 5, 1996, pp. 1934–39. Blumenthal and his colleagues asked more than two thousand teaching physicians about their relationships with industry and their publishing habits. Less than a third took money from industry. Scientists funded partially by industry published just as often as their publicly funded colleagues, except for the minority who took more than two-thirds of their money from industry. That minority published less often, were more likely to withhold information from colleagues, and were more likely to have generated trade secrets for their patrons.
13. Kevin Parent, Postgraduate Medicine 96 (Nov. 1, 1994): 53.
14. Henry J. Kaiser Family Foundation, “Prescription Drug Trends,” Nov. 2001.
15. NIH, NIH Contributions to Pharmaceutical Development, pp. 12–13.
16. Gardiner Harris, “Prilosec’s Maker Switches Users to Nexium, Thwarting Generics,” Wall Street Journal, June 6, 2002.
17. Sachs interview.
18. Harris, “Prilosec’s Maker.”
19. Stephen Hall, “The Claritin Effect: Prescription for Profit,” New York Times Magazine, Mar. 11, 2001.
20. Gardiner Harris, “As Blockbuster Claritin Goes Generic, Schering-Plough Pushes a Close Sibling,” Wall Street Journal, Mar. 21, 2002. See also Scott Hensley, “More Than Ads, Drug Makers Rely on Sales Representatives,” Wall Street Journal, Mar. 14, 2002.
21. Andrew Pollack, “Battling Searle, University Gets Broad Patent for New Painkiller,” New York Times, Apr. 12, 2000.
22. Gardiner Harris, “When Its Patents Expired, Merck Didn’t Merge—It Found New Drugs,” Wall Street Journal, Jan. 10, 2001.
23. Pharmaceutical Research and Manufacturers Association, “Pharmaceutical Industry Honors Discoverers of Celebrex,” press release, Mar. 25, 2002. Numerous studies in the academic literature have shown that Cox-2 inhibitors are no better than ibuprofen, diclofenac, and naproxen sodium for reducing aches and pains; see, for instance, A. J. Matheson and D. P. Figgitt, “Rofecoxib: A Review of Its Use in the Management of Osteoarthritis, Acute Pain and Rheumatoid Arthritis,” Drugs 61, no. 6 (2001): 833–65; see also R. Hawel et al., “Comparison of the Efficacy and Tolerability of Dexibuprofen and Celecoxib in the Treatment of Osteoarthritis of the Hip,” International Journal of Clinical Pharmacology and Therapeutics 4 (Apr. 2003): 153–64.
24. See for instance the special supplement to the American Journal of Medicine, Mar. 30, 1998.
25. Elizabeth Neus, “New Arthritis Relief: Pain-Killers Promise to Be Tummy-Friendly,” Chicago Sun-Times, Oct. 28, 1998.
26. “Conquering Pain,” Business Week, Mar. 1, 1999, p. 104.
27. “FDA Approves Pain Reliever with Fewer Side Effects,” Washington Post, May 22, 1999.
28. Centers for Disease Control and Prevention, National Vital Statistics Report 47 (June 30, 1999); Susan Levenstein et al., “Stress and Peptic Ulcer Disease,” Journal of the American Medical Association, Jan. 6, 1999; T. M. Mac-Donald et al., “Association of Upper Gastrointestinal Toxicity of Nonsteroidal Anti-inflammatory Drugs with Continued Exposure: Cohort Study,” British Medical Journal, Nov. 22, 1997.
29. David R. Lichtenstein and M. Michael Wolfe, “COX-2-selective NSAIDS: New and Improved?” The Journal of the American Medical Association, Sept. 13, 2000, pp. 1297–99.
30. Garret A. FitzGerald and Carlo Patrono, “The Coxibs, Selective Inhibitors of Cyclooxygenase-2,” The New England Journal of Medicine, Aug. 9, 2001, pp. 433–42.
31. Melody Petersen, “Doubts Are Raised on the Safety of Two Popular Arthritis Drugs,” New York Times, May 22, 2001.
32. FDA, “FDA Approves New Indication and Label Changes for the Arthritis Drug, Vioxx,” press release, Apr. 11, 2002.
33. Susan Okie, “Missing Data on Celebrex: Full Study Altered Picture of Drug,” Washington Post, Aug. 5, 2001.
34. Peter Jüni, Anne Rutjes, and Paul Dieppe, “Are Selective Cox-2 Inhibitors Superior to Traditional Nonsteroidal Anti-inflammatory Drugs?” British Medical Journal, June 1, 2002, pp. 1287–88.
35. Henry J. Kaiser Family Foundation, “Prescription Drug Trends: A Chart-book Update,” Nov. 2001, p. 31.
36. Marcia Angell, “The Pharmaceutical Industry: To Whom Is It Accountable?” The New England Journal of Medicine, June 22, 2000, p. 1904.
1. Joseph A. DiMasi, Price Trends for Prescription Pharmaceuticals, 1995–1999, Tufts Center for the Study of Drug Development, Aug. 2000. The study purported to show that me-too drugs resulted in competition. But it chose a 5-percent differential as significant. Simply by expanding the price differential to 10 percent, the number of drugs that resulted in significant price competition fell to less than half. Only five of the twenty drugs entered the market 30 percent or more below existing prices, which one would have expected from all firms intent on seizing significant market share.
2. David Noonan with Joan Raymond and Anne Belli Gesalman, “Why Drugs Cost So Much,” Newsweek, Sept. 25, 2000, p. 22.
3. Henry J. Kaiser Family Foundation, Prescription Drug Trends: A Chart-book Update, Nov. 2001. See also National Institute for Health Care Management, Prescription Drug Expenditures in 2001: Another Year of Escalating Costs, Apr. 2002; and National Institute for Health Care Management, Prescription Drugs and Mass Media Advertising, 2000, Nov. 2001.
4. Henry J. Kaiser Family Foundation, Prescription Drug Trends.
5. Chunliu Zhan et al., “Potentially Inappropriate Medication Use in the Community-Dwelling Elderly,” Journal of the American Medical Association, Dec. 12, 2001, pp. 2823–29.
6. Henry J. Kaiser Family Foundation, Prescription Drug Trends; see also Pharmaceutical Research and Manufacturers Association, “Annual Report, 2001–2002,” p. 13.
7. Thomas Maeder, “The FDA Meets the Twenty-first Century,” Understanding Government, http://www.understandinggovernment.org/maeder.html (accessed Mar. 25, 2003).
8. See, for instance, Chris Adams, “Doctors ‘Dine n’ Dash’ in Style, As Drug Firms Pick Up the Tab,” Wall Street Journal, May 14, 2001; Scott Hensley, “More Than Ads, Drug Makers Rely on Sales Representatives,” Wall Street Journal, Mar. 14, 2002; Robert Pear, “Drug Industry Is Told to Stop Gifts to Doctors,” New York Times, Oct. 1, 2002.
9. Harris, The Real Voice, p. 76.
10. Alan F. Holmer, “Innovation Is Key Mission,” USA Today, May 31, 2002.
11. Life expectancy statistics are available on the Centers for Disease Control Web site, http://www.cdc.gov; e-mail communication from S. Jay Olshansky, Oct. 16, 2002.
12. Runner’s World, Oct. 2002. See also National Association for Sport and Physical Education, The Shape of the Nation Report, Oct. 2001.
13. See Ronald Bailey, ed., Global Warming and Other Eco-Myths: How the Environmental Movement Uses False Science to Scare Us to Death; and Samuel S. Epstein, The Politics of Cancer Revisited.
14. Holmer, “Innovation Is Key Mission.”
15. Joseph A. DiMasi et al., “Cost of Innovation in the Pharmaceutical Industry,” Journal of Health Economics 10 (1991): 107–42.
16. Tufts Center for the Study of Drug Development, “Tufts Center for the Study of Drug Development Pegs Cost of New Prescription Medicine at $802 Million,” press release, Nov. 30, 2001.
17. Data provided by the Division of AIDS, NIAID.
18. Government Accounting Office, “NIH Clinical Trials: Various Factors Affect Patient Participation,” Report to Congressional Requesters, Sept. 1999.
19. Alice Dembner, “Critics Say Drug Trials Often a Marketing Tool,” Boston Globe, June 25, 2002; Sheryl Gay Stolberg and Jeff Gerth, “Medicine Merchants: How Research Benefits Marketing,” New York Times, Dec. 23, 2000.
20. Melody Petersen, “Madison Ave. Plays Growing Role in Drug Research,” New York Times, Nov. 22, 2002; Frank Davidoff et al., “Sponsorship, Authorship and Accountability, New England Journal of Medicine, Sept. 13, 2001, pp. 825–27.
21. Public Citizen, “Rx R&D Myths: The Case Against the Drug Industry’s R&D ‘Scare Card,’ ” Public Citizen Congress Watch, Aug. 8, 2001.
22. Ernst and Young LLP, “Pharmaceutical Industry R&D Costs: Key Findings about the Public Citizen Report,” Aug. 8, 2001, posted on the Pharmaceutical Research and Manufacturers Association Web site, http://www.phrma.org/mediaroom/press/releases//2001-08-11.227.pdf (accessed Oct. 15, 2003).
23. Telephone interview with Baruch Lev, Oct. 15, 2002.
24. David Willman, “‘Fast-Track’ Drug to Treat Diabetes Tied to 33 Deaths,” Los Angeles Times, Dec. 6, 1998.
25. Daniel W. Sigelman, “Dangerous Medicine,” The American Prospect, Sept. 23, 2002.
26. National Institute for Health Care Management Research and Education Foundation, Changing Patterns of Pharmaceutical Innovation, May 2002; see also Melody Peterson, “New Medicines Seldom Contain Anything New, Study Finds,” New York Times, May 29, 2002.
27. Pharmaceutical Research and Manufacturers Association, NIHCM’s Report on Pharmaceutical Innovation: Fact vs. Fiction, a preliminary report, June 11, 2002.
28. Ibid.
29. Industry statistics from the Biotechnology Industry Organization Web site, http://www.bio.org/news/stats.asp (accessed Oct. 15, 2003).
30. Andrew Pollack, “Despite Billions for Discoveries, Pipeline for Drugs Is Far from Full,” New York Times, Apr. 19, 2002.
31. Andrew Pollack, “Once Novel Drug Company No Longer Sets Pace,” New York Times, Apr. 18, 2002.
32. Gardiner Harris, “Drug Firms, Stymied in the Lab, Become Marketing Machines,” Wall Street Journal, July 6, 2000; Gardiner Harris, “Why Drug Makers Are Failing in Quest for New Blockbusters,” Wall Street Journal, Apr. 18, 2002.
33. See Harris, “Why Drug Makers Are Failing.”
34. Speech to the Association of University Technology Managers, San Diego, Feb. 28, 2002.
35. The Global Alliance for TB Drug Development, The Economics of TB Drug Development, Oct. 2001, p. 66.
1. ALLHAT officers and coordinator for the ALLHAT Collaborative Research Group, “Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs. Diuretic,” Journal of the American Medical Association, Dec. 18, 2002, pp. 2981–97. National Heart, Lung and Blood Institute, press conference, Dec. 17, 2002.
2. Edward D. Frohlich, “Treating Hypertension: What Are We to Believe?” New England Journal of Medicine, Feb. 13, 2003, pp. 639–41.
3. Richard Mayeux and Mary Sano, “Treatment of Alzheimer’s Disease,” New England Journal of Medicine, Nov. 25, 1999, pp. 1670–79.
4. Interview with David Blumenthal, May 30, 2000. Blumenthal, a professor at Harvard Medical School and director of the Massachusetts General Hospital Institute of Health Policy, has been tracking industry-university relations in medicine since the Carter administration.
5. Thomas M. Burton, “Left on the Shelf: Why Cheap Drugs That Appear to Halt Fatal Sepsis Go Unused,” Wall Street Journal, May 17, 2002; Thomas M. Burton, “French Study Bolsters Steroids as Treatment for Deadly Sepsis,” Wall Street Journal, Aug. 21, 2002.
6. Stuart H. Altman and Cindy Parks-Thomas, “Controlling Spending on Prescription Drugs,” New England Journal of Medicine, Mar. 14, 2002, pp. 855–56.
7. Marcia Angell, “The Pharmaceutical Industry.”
8. The SNP Consortium Ltd. Web site: http://snp.cshl.org/about/. In a paper prepared for a conference at Duke University in Nov. 2002 (“The Public and the Private in Biopharmaceutical Research”), intellectual property law professors Arti K. Rai and Rebecca S. Eisenberg argued that “the willingness of private firms in a patent-sensitive industry to spend money to enhance the public domain is powerful evidence that intellectual property rights in the research results threaten to create significant barriers to subsequent research and product development.”
9. This point is made in several articles contained in David Korn and Stephen J. Heinig, eds., “Public versus Private Ownership of Scientific Discovery: Legal and Economic Analyses of the Implications of Human Gene Patents,” Academic Medicine, pt. 2, Dec. 2002.
10. Scott Hensley, “Pfizer Sues to Block Viagra Rivals,” Wall Street Journal, Oct. 23, 2002. University of Rochester v. G. D. Searle and Co., U.S. District Court, Western District of New York, decided Mar. 5, 2003, http://www.nywd.uscourts.gov/decision/20030305_00cv6161_larimer.pdf (accessed Mar. 5, 2003).
11. See, for instance, the Web site of Campaign for Access to Essential Medicines on the Doctors Without Borders Web site, http://www.accessmed-msf.org/index.asp#.
12. David Perlman, “Drug Firm Seeks Cures over Cash,” San Francisco Chronicle, Aug. 19, 2002.
13. Interview with Victoria Hale, Feb. 26, 2003.
14. Perlman, “Drug Firm Seeks Cures.”
15. Interview with Carol Nacy, June 21, 2002.
16. Drews, In Quest of Tomorrow’s Medicines, p. 234.
17. Nacy interview.