1 Clifton Leaf, “The Law of Unintended Consequences,” Fortune, September 19, 2005, http://money.cnn.com/magazines/fortune/fortune_archive/
2005/09/19/8272884/index.htm (accessed September 3, 2008).
2 Diamond v. Chakrabarty, 447 U.S. 303 (1980). The Pseudomonas microorganism patented in Chakrabarty degraded or “ate” crude oil. Its creation promised a revolutionary ecological breakthrough in the methodology of cleaning up oil spills and anticipated important genetic engineering feats that usefully transformed microorganisms.
3 Sheldon Krimsky, Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? (New York: Rowman & Littlefield Publishers, Inc., 2004), passim.
4 Fortune 500, “Top Industries: Most Profitable,” May 4, 2009, http://money.cnn.com/magazines/fortune/fortune500/2009/
performers/industries/profits/.
5 “Landmark Study Reports Breakdown in Biotech Patent System,” PhysOrg.com, September 9, 2008, http://www.physorg.com/news140178906.html (accessed May 24, 2011).
6. Jess Bravin, “In Reversal, Court Rules Human Gene Can Be Patented,” Wall Street Journal, July 30, 2011 http://online.wsj.com/article/
SB10001424053111903635604576476130562033622.html (accessed August 2, 2011).
1 Andrew Kimbrell, The Human Body Shop: The Engineering and Marketing of Life (New York: HarperCollins, 1993), 245.
2 Judith Ann Schiff, “An Unsung Hero of Medical Research: A Technique Invented Nearly 100 Years Ago by a Yale Scientist Led to a Revolution in Biology,” Yale Alumni Magazine 64, no. 2 (February 2001), http://www.yalealumnimagazine.com/issues/02_02/old_yale.html (accessed November 21, 2010).
3 Bruce Alberts et al., eds., The Molecular Biology of the Cell, 4th ed. (New York: Garland Science, 2002).
4 United States Congress, U.S. Office of Technology Assessment, Ownership of Human Tissues and Cells: New Developments in Biotechnology (Washington, D.C.: U.S. Office of Technology Assessment, 2002).
5 “Update: U. Cal. and the Hagiwaras Settle Ownership Dispute,” Biotechnology Law Report 2, no. 3–4 (1983): 43.
6 Marjorie Sun, “Scientists Settle Cell Line Dispute: But Question of Claiming Ownership Based on Family Ties to Cell Donor Is Sidestepped,” Science 220, no. 4595 (April 1983): 393.
7 “Pair Charged with Theft of Trade Secrets from Harvard Medical School,” U.S. Department of Justice press release (Washington, D.C., June 19, 2002), http://www.justice.gov/criminal/cybercrime/zhuCharges.html.
8 United States v. Zhu, 02-M-0421 (June 19, 2002).
9 Andrew Lawler, “Arrest of Ex-Harvard Postdocs Raises Questions of Ownership,” Science 296, no. 5577 (June 28, 2002): 2310.
10 Adam M. Guren, “HMS Fellows Indicted for Alleged Lab Theft,” The Harvard Crimson, June 27, 2005, http://www.thecrimson.com/article/2005/6/27/hms-fellows-indicted-for-alleged-lab/.
11 Andrew Lawler, “U.S. Asks for Delay in Science Theft Case,” Science 297, no. 5581 (July 26, 2002): 496.
12 Charles Anthon, A Classical Dictionary: Containing an Account of the Principal Proper Names Mentioned in Ancient Authors, and Intended to Elucidate All the Important Points Connected with the Geography, History, Biography, Mythology, and Fine Arts of the Greeks and Romans Together with an Account of Coins, Weights, and Measures, with Tabular Values of the Same (New York: Harper & Bros., 1841), 1273.
13 M. Frumkin, “The Origin of Patents,” Journal of the Patent Office Society 27, no. 3 (March 1945): 143.
14 Toshiko Takenaka, Patent Law and Theory: A Handbook of Contemporary Research (Northampton, MA: Edward Elgar Publishing, 2009), 101, 139, 359.
15 Devon Fanfair, Salil Desai, and Christopher Kelty, “Patent or Perish,” in Nanotechnology: Content and Context, eds. Christopher Kelty and John Hutchinson (Houston: Rice University, May 2007), 59–71, http://cnx.org/content/m14509/1.1/.
16 Adam Mossoff, “Rethinking the Development of Patents: An Intellectual History, 1550–1800,” Hastings Law Journal 52 (2001): 1255.
17 Krimsky, Science in the Private Interest, 58.
18 Benjamin Franklin, The Autobiography of Benjamin Franklin, p. 55, http://www.ushistory.org/franklin/autobiography/page55.htm (accessed May 20, 2011).
19 U.S. Constitution, Art. I, sec. 8, cl. 8.
20 Thomas O. Jewett, “Thomas Jefferson: Father of Invention,” The Early America Review 3, no. 1 (Winter 2000), http://www.earlyamerica.com/review/winter2000/jefferson.html (accessed November 21, 2010).
21 Ibid.
22 Some accounts credit Jefferson with approximately sixty-four patent approvals: Ibid.
23 Kenneth W. Dobyns, The Patent Office Pony: A History of the Early Patent Office, http://www.myoutbox.net/popch25.htm (accessed November 22, 2010). Also available in print (Fredericksburg, VA: Sargeant Kirkland’s Museum and Historical Society, 1994).
24 Abraham Lincoln, “Second Lecture on Discoveries and Inventions” (lecture, Jackson, IL, February 11, 1859), cited in Abraham Lincoln Online, http://showcase.netins.net/web/creative/lincoln/speeches/discoveries.htm.
25 Adam Mossoff, “Who Cares What Thomas Jefferson Thought About Patents? Reevaluating the Patent ‘Privilege’ in Historical Context,” Cornell Law Review 92, no. 953 (2007): 1012.
26 Atlantic Works v. Brady, 1017 U.S. 192, 200 (1883).
27 United States Supreme Court Reporter (Rochester, NY: Lawyers’ Cooperative Publishing Co.), 27:439, 440.
28 “On October 6th, U.S. President William Clinton is expected to join the U.S. Secretary of Agriculture Dan Glickman and other national leaders to honor one of America’s greatest scientists,” Tuskegee University press release (Tuskegee, AL, October 6, 2001). Only a few of Carver’s inventions were patented, some reportedly to benefit the university.
29 Fanfair et al., “Patent or Perish.”
30 David Holcberg, “Should Genes Be Patented?” Capitalism Magazine, April 13, 2002, http://www.capitalismmagazine.com/science/genetics/1534-should-genes-be-patented.html (accessed November 23, 2010).
31 Sinclair Lewis, Arrowsmith (New York: Modern Library, 1925), 72.
32 Krimsky, Science in the Private Interest, 77.
33 Merrill Goozner, The $800 Million Pill: The Truth Behind the Cost of New Drugs (Berkeley: University of California Press, 2004), 106, 212.
34 Jane Smith, Patenting the Sun: Polio and the Salk Vaccine (New York: William Morrow, 1990), 159.
35 Nelson Rees was codirector of the Cell Culture Laboratory at the Naval Biosciences Laboratory in Oakland, California. This laboratory was part of the University of California, Berkeley.
36 Michael A. Gold, A Conspiracy of Cells: One Woman’s Immortal Legacy and the Medical Scandal It Caused (Albany, NY: SUNY Press, 1986), 7; Hannah Landecker, “Immortality, in Vitro: A History of the HeLa Cell Line,” in Biotechnology and Culture: Bodies, Anxieties, Ethics, ed. Paul Brodwin (Bloomington: Indiana University Press, 2000), 53–74.
37 H. G. Dexler, W. G. Dirks, and R. A. Macleod, “False Human Hematopoietic Cell Lines: Cross-Contaminations and Misinterpretations,” Leukemia 13, no. 10 (October 1999): 1601.
38 Harriet Washington, “Henrietta Lacks: An Unsung Hero,” Emerge Magazine 6, no. 1 (October 1994): 29.
39 Harriet Washington, “Henrietta Lacks”; W. A. Nelson-Reses and R. R. Flandermeyer, “HeLa Cultures Defined,” Science 191, no. 4222 (January 1976): 96. The abstract clearly notes the importance of the tissues gleaned from Lacks’s children in establishing the identity of HeLa cells versus those derived from other cell lines. The abstract reads in part, “[g]enotype of the patient Henrietta Lacks from whose cervical carcinoma the HeLa cell was derived was deduced from the phenotypes of her husband and children, and from studies of the HeLa cell. Hemizygous expression of glucose & phosphate dehydrogenase in HeLa, together with the deduced heterozygosity of Mrs. Lacks, is consistent with clonal origin of her neoplasm” (italics mine).
40 Russell W. Brown and James Henderson, “The Mass Production and Distribution of HeLa Cells at Tuskgee Institute, 1953–1955,” Journal of the History of Medicine and Allied Sciences (1983) 38(4): 415–31.
41 However, Gey had chosen to disseminate the pseudonyms only after Henrietta Lacks’s name had been discovered by journalists, presumably to confuse them and to induce them to adopt a fictitious name as real.
42 Landecker, “Immortality, in Vitro: A History of the HeLa Cell Line,” 53–74.
43 Harriet Washington, “Henrietta Lacks,” 29.
44 William J. Curran Esq., Harvard School of Public Health, personal interviews with the author, October 10, 1991, and March 23, 1992; telephone interview with the author, June 10, 1994.
45 Joe Miller, “Patent Law: How Patents Grew over Time to Include Living Organisms,” Cooking Up a Story, July 29, 2009, http://cookingupastory.com/patent-law-how-patents-grew-over-time-to-include-living-organisms (accessed November 22, 2010).
46 L. Hayflick and P. S. Moorhead, “The Serial Cultivation of Human Diploid Cell Strains,” Experimental Cell Research 25 (1961): 585–621.
47 John Walsh, “Public Attitude Toward Science Is Yes, But—” Science 15, no. 4530 (January 1982): 270–72. The suit also claimed that Hayflick “had sold cells that had been accidentally contaminated with bacteria and cleaned up with antibiotics, without informing the appropriate authorities about the previous contamination.”
48 Philip M. Boffey, “The Fall and Rise of Leonard Hayflick, Biologist Whose Fight with U.S. Seems Over,” New York Times, January 19, 1982.
49 WI-38 was developed by Dr. Leonard Hayflick in 1962, by taking lung cells from an aborted female baby at approximately the end of the third month of pregnancy. His article in Experimental Cell Research states that “all embryos were obtained from surgical abortions and were of approximately three months’ gestation.”
50 A. M. Chakrabarty, “Patenting of Life-Form: From a Concept to Reality,” in Who Owns Life?, eds. David Magnus, Arthur Caplan, and Glenn McGee (Amherst, NY: Prometheus Books, 2002), 25–39.
51 Ibid., 18.
52 Diamond v. Chakrabarty, 447 U.S. 303 (1980).
53 Donald S. Chisum, Craig A. Nard, Herbert E. Schwartz, Pauline Newman, and F. Scott Kieff, Principles of Patent Law: Cases and Materials (New York: Foundation Press, 1998), 783–88.
54 Council on Governmental Relations, “The Bayh-Dole Act: A Guide to the Law and Implementing Regulations,” September 1999, http://www.ucop.edu/ott/bayh.html.
55 Patent Rights in Inventions Made with Federal Assistance, U.S. Code 35 (February 2010), chap. 18.
56 United States Congress, Senate Committee on the Judiciary, The University and Small Business Patent Procedures Act: Hearings Before the Committee on the Judiciary on S. 414, 96th Cong., 1st sess., May 16 and June 6, 1979.
57 Birch Bayh, interview by Gene Quinn, IP Watchdog, December 15, 2010, http://ipwatchdog.com/2010/11/07/exclusive-interview-senator-birch-bayh-on-bayh-dole/id=13198/ (accessed December 24, 2010).
58 Bayh-Dole Act of 1980, U.S. Code 35 (February 2010), chap. 18, sec. 200 (December 12, 1980). The text of the Bayh-Dole Act is available at www.cptech.org/ip/health/bd (accessed May, 2009).
59 Leaf, “The Law of Unintended Consequences.”
60 Council on Governmental Relations, “The Bayh-Dole Act.”
61 Stevenson-Wydler Technology Innovation Act of 1980, U.S. Code 15 (February 2010), chap. 63, sec. 3701 (October 21, 1980).
62 The Economic Recovery Tax Act of 1981, Public Law 97-34, U.S. Statutes at Large 95 (1981): 172.
63 The Federal Technology Transfer Act of 1986 (Public Law 99-502) amended the Stevenson-Wydler Innovation Act by mandating technology transfer for federal and requiring that preference be given to U.S. corporate partners. Subsequently, the National Competitiveness Technology Transfer Act of 1989 (Public Law 101-189) exhorted contractor laboratories (GOCO) to cooperate with corporations and universities.
64 Golde signed contracts with the Genetics Institute, Inc., Sandoz, Ltd., Sandoz United States, Inc., and Sandoz Pharmaceutical Corporation in 1981, 1982, and 1983.
65 His claim was dismissed in 1986, but a 1988 appeal acknowledged Moore’s property ownership rights of his tissues and gave him a share of the patent. However, this decision was reversed in 1990 when the court held that Moore had no property rights in his own tissue, although Moore could sue Golde for a share on the basis that Golde had not fulfilled his “fiduciary duty” to tell Moore that his spleen was a potential gold mine. Defendants argued that they should have to disclose in part because the donor might object to taking part in research. Had the 1988 appellate decision been upheld, others who found themselves in the same position might have become at least partial owners of the lucrative cell lines established from their bodies—a biotechnology firm’s nightmare, and a potential windfall for people such as the Lackses.
66 Jeremy Pearce, “Dr. David Golde, 63, Expert on Blood Disorders, Is Dead,” New York Times, August 14, 2004.
67 John Vidal and John Carvel, “Lambs to the Gene Market,” Guardian, November 12, 1994.
68 Rick Weiss, “US Denies Patent for Part-Human Hybrid,” Washington Post, February 13, 2005.
69 Ibid.
70 Gene Quinn, “PTO Hiring Freeze and Budget Problems,” IPWatchDog, March 2, 2009, www.ipwatchdog.com/2009/03/02/pto-hiring-freeze-and-budget-problems/id=2099/ (accessed 14 August 2009).
71 In late 2008, a large number of patent examiners were hired, which is a step in the right direction. Before then, a mere two hundred PhDs were charged with evaluating the life-patent-related applications that flooded the office, including a backlog of nearly eight hundred thousand applications.
72 “In early 2000, the US Patent and Trademark Office received a patent application of 400,000 pages. Not much later, the European Patent Office received one of 500,000 pages. Since May of this year, USPTO has on its hands a patent application from Shell Oil bearing no less than 7,200 individual claims”: GRAIN, One Global Patent System? WIPO’s Substantive Patent Law Treaty (Barcelona, Spain, October 2003), http://www.grain.org/briefings/?id=159.
73 Gene Quinn, “Patent Examiners Told to Issue Patents,” IPWatchdog, May 22, 2009, www.ipwatchdog.com/2009/05/22/patent-examiners-told-to-issue-patents/id=3671/Last (accessed June 22, 2009).
74 Leaf, “The Law of Unintended Consequences.”
75 Ibid.
76 Ibid.
77 Ibid.
78 Samantha Stainburn, “Who Owns Your Great Idea?” New York Times, January 4, 2009, http://www.nytimes.com/2009/01/04/education/edlife/whoseidea-t.html.
79 Ibid.
80 James D. Watson, The Double Helix: A Personal Account of the Discovery of the Structure of DNA (New York: Atheneum, 1968; London: Weidenfeld and Nicolson, 1981), 16–19, 69–71, 166–70.
81 Krimsky, Science in the Private Interest.
82 Sheldon Krimsky, “Perils of University-Industry Collaboration,” Issues in Science and Technology 16, no. 1 (September 22, 1999): 14.
1 “Heather” is not her real name, and some elements of her story have been changed to protect her privacy.
2 Elan Corporation, Plc., “2001 Annual Report and Form 20-F,” July 3, 2005, http://en.wikipedia.org/wiki/Primidone-cite_ref-elanrationalise_41-oÉlan Corporation (accessed July 4, 2008).
3 Eva C. Winkler, MD, and Russell L. Gruen, MD, PhD, “Principles for Ethical Decision-Making in Healthcare Organizations,” unpublished manuscript.
4 Richard Pazdur, MD, “FDA Approval for Cetuximab,” National Cancer Institute, Cancer Drug Information, http://www.cancer.gov/cancertopics/druginfo/fda-cetuximab
5 Robert Bazell, “Strange Medicine: Why Are the New Cancer Drugs So Expensive?” Slate, Wednesday, June 23, 2004, http://www.slate.com/id/2102844/.
6 Matthew Herper, “The World’s Most Expensive Drugs,” Forbes.com, February 22, 2010, http://www.forbes.com/2010/02/19/expensive-drugs-cost-business-healthcare-rare-diseases.html.
7 “Roche and Genentech Reach a Friendly Agreement to Combine the Two Organizations and Create a Leader in Healthcare Innovation,” The Roche Group media release (Basel, Switzerland, March 12, 2009), http://www.roche.com/media/media_releases/med-cor-2009–03–12.htm.
8 The Pharmaceutical Research and Manufacturers of America, “Inside Innovation: The Drug Discovery Process,” Innovation.org, http://www.innovation.org/index.cfm/InsideDrugDiscovery.
9 “Most Expensive Medicine—World Record Set by Soliris,” World Records Academy, February 23, 2010, http://www.worldrecordsacademy.org/business/
most_expensive_medicine_world_record_set_by_Soliris_101573.htm (accessed December 18, 2010).
10 Roger Collier, “Drug Development Cost Estimates Hard to Swallow,” Canadian Medical Association Journal 180, no. 3 (2009): 279–80.
11 J. A. DiMasi, “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics 22, no. 2 (March 2003): 151–85.
12 The 1987 cost, unadjusted for inflation, had been calculated at $231 million: Robert Pear, “Research Cost for New Drugs Said to Soar,” New York Times, December 1, 2001.
13 James Love, “IRS Data Shows Drug Industry Cost Estimates Exaggerated,” Knowledge Economy International news release (Washington, D.C, November 30, 2001), http://www.lists.essential.org/pipermail/ip-health/2001-November/002489.html.
14 George Foster, “Opposing Forces in a Revolution in International Patent Protection: the U.S. and India in the Uruguay Round and Its Aftermath,” UCLA Journal of International Law and Foreign Affairs 3 (1998): 283.
15 “DiMasi’s new study puts out-of-pocket clinical trial costs at $282 million, based on the NCEs [NMEs] in his study. His estimate is four times more than an estimate of clinical trial costs ($75 million) published by the Congressional Research Service in April 2001. Moreover, DiMasi’s estimate of clinical trial costs greatly exceeds the drug industry’s own data on the subject. PhRMA’s own survey of 1999 R&D expenditures states that clinical trial costs account for 29 percent of all R&D costs. (See Table 6, ‘Domestic U.S. R&D by Function’ in ‘Pharmaceutical Industry Profile 2001.’) Yet DiMasi’s study says clinical trials account for 70 percent of all R&D costs ($282 million out of $403 million total out-of-pocket expenditures for each drug).”: “Critique of the DiMasi/Tufts Methodology and Other Key Prescription Drug R&D Issues,” Public Citizen, http://www.citizen.org/congress/article_redirect.cfm?ID=6532 (accessed December 4, 2010).
16 The Pharmaceutical Research and Manufacturers of America, “Survey of 1999 R&D Expenditures: Table 6, Domestic U.S. R & D by function,” Pharmaceutical Industry Profile 2001, cited in “Critique of the DiMasi/Tufts Methodology and Other Key Prescription Drug R&D Issues,” Public Citizen.
17 Numbers of NMEs approved per year: 2009, twenty-six; 2008, twenty-five; 2007, eighteen; 2006, twenty-two; 2005, twenty-six; 2004, twenty-four; 2003, twenty-six; 2002, twenty-eight; 2001, twenty-three; 2000, twenty-six; 1999, thirty-three: “New Molecular Entity Approvals for 2010,” United States Food and Drug Administration, February 17, 2011, http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/
ucm242674.htm.
18 The Economist, “Economics A-Z: Opportunity Cost,” http://www.economist.com/research/Economics/alphabetic.cfm?letter=O#opportunitycos (accessed December 4, 2010); George Stigler, “The Nature and Role of Originality in Scientific Progress,” Economica 12 (November 1955).
19 “Tufts Drug Study Sample Is Skewed; True Figure of R&D Costs Likely Is 75 Percent Lower,” Public Citizen press release (Washington, D.C., December 4, 2001), http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=954.
20 “The Net Cost of Every Dollar Spent on R&D Must Be Reduced by the Amount of Tax Avoided by that Expenditure”: United States Congress, U.S. Office of Technology Assessment, Ownership of Human Tissues and Cells: New Developments in Biotechnology (Washington, D.C.: U.S. Office of Technology Assessment, 2002), 15.
21 A 2002 report by the General Accounting Office compared the average costs of noncommercial, government-funded clinical research to that conducted by the drug industry and found that drug makers’ costs were significantly higher than that of comparable government-managed clinical trials.
22 Goozner, The $800 Million Pill, 239.
23 They do so by preventing the enzyme HMG-CoA reductase from allowing runaway cholesterol production by the liver.
24 Goozner, The $800 Million Pill, 238; Melody Peterson, “Madison Avenue Plays Growing Role in Drug Research,” New York Times, November 22, 2002.
25 Frank Davidoff et al., “Sponsorship Authorship and Accountability,” New England Journal of Medicine 286, no. 10 (September 2001): 825.
26 “Critique of the DiMasi/Tufts Methodology and Other Key Prescription Drug R&D Issues,” Public Citizen.
27 Pear, “Research Cost for New Drugs Said to Soar.”
28 By contrast, therapeutic equivalence is necessary to permit pharmacists to substitute a generic drug for a branded drug when filling a prescription. Therapeutic equivalence applies to those medications that have both bio-equivalence and pharmaceutical equivalence (that they share the same active ingredient, strength, and manner of administration).
29 Pauline W. Chen, MD, “When Patients Don’t Fill Their Prescriptions,” New York Times, May 20, 2010.
30 Stephen Schondelmeyer and Leigh Purvis, “Trends in Retail Prices of Brand Name Prescription Drugs Widely Used by Medicare Beneficiaries, 2005 to 2009,” Rx Price Watch Report (Washington, D.C.: AARP Public Policy Institute, August 2010), http://assets.aarp.org/rgcenter/ppi/health-care/rxpricewatch.pdf.
31 “Average Health Insurance Premiums and Worker Contributions for Family Coverage, 1999–2009,” Kaiser/HRET Survey of Employer-Sponsored Health Benefits, 1999–2009, Henry J. Kaiser Family Foundation, September 15, 2009, http://slides.kff.org/chart.aspx?ch=1182.
32 CMS Data Compendium, Centers for Medicare & Medicare Services, U.S. Department of Health and Human Services, December 14, 2005, https://www.cms.gov/DataCompendium (accessed May 11, 2009).
33 Gay Men’s Health Crisis, Inc., “First Wave of Cuts Hits New York’s ADAP,” Treatment Issues, ed. Bob Huff, December 2002, http://www.thebody.com/content/art13619.html.
34 Becky Allen, “September 2010 ADAP Update: The Sprinklers Are On, but the Water Pressure’s Low,” The Body Pro, September 23, 2010, http://www.thebodypro.com/content/art58596.html.
35 Laurie Felland and James Reschovsky, “More Non-Elderly Americans Face Problems Affording Prescription Drugs,” Center for Studying Health System Change Tracking Report No. 22 (Washington, D.C.: HSC, January 2009), www.hschange.org/CONTENT/1039/ (accessed February 11, 2010).
36 Roger H. Rumble and Kevin Morgan, “Longitudinal Trends in Prescribing for Elderly Patients: Two Surveys Four Years Apart,” British Journal of General Practice 44 (1994): 571–75; James Wooten, PharmD, and Julie Galavis, RN, BSN, “Polypharmacy: Keeping the Elderly Safe,” Modern Medicine, August 1, 2005, http://www.modernmedicine.com/modernmedicine/CE+Library/Polypharmacy-Keeping-the-elderly-safe/ArticleStandard/Article/detail/172920.
37 “Summary and Charts,” Survey: The Public on Prescription Drugs and Pharmaceutical Companies, USA Today/Kaiser Family Foundation/Harvard School of Public Health, March 4, 2008, p. 3, http://www.kff.org/kaiserpolls/7748.cfm.
38 “Putting Off Care Because of Cost,” Health Tracking Poll, Henry J. Kaiser Family Foundation, July 14, 2009, http://www.kff.org/kaiserpolls/upload/7944.pdf. This nationally representative, random sample survey of 1,695 adults ages eighteen years and older was conducted by telephone from January 3 to January 23, 2008. The margin of sampling error for the survey is plus or minus 3 percentage points for total respondents.
39 Paying lobbyists by individual pharmaceutical companies such as Pfizer and Amgen constituted the bulk of the difference between PhRMA’s expenditures and that for the category in toto: “Pharmaceuticals/Health Products 2010,” Lobbying Spending Database, OpenSecrets.org/Center for Responsive Politics, January 31, 2010, http://www.opensecrets.org/lobby/indusclient.php?lname=Ho4&year=a (accessed March 27, 2010).
40 “Top Industries 2010,” Lobbying Spending Database, OpenSecrets.org/Center for Responsive Politics, January 31, 2001, http://www.opensecrets.org/lobby/top.php?showYear=2009&indexType=i (accessed March 27, 2010).
41 “Bristol-Myers Squibb: Summary,” Heavy Hitters: Bristol-Myers Squibb, Open Secrets.org Center for Responsive Politics, www.opensecrets.org/orgs/summary.php?id=D000000149 (accessed August 21, 2009).
42 Gilbert Ross, “Why Drug ‘Reimportation’ Won’t Die: The Drug Industry Made a Foolish Bet in Supporting Health Reform,” Wall Street Journal, January 7, 2010.
43 Roger Pilon, “Drug Reimportation: The Free Market Solution,” CATO Institute Policy Analysis no. 521, August 4, 2004, http://www.cato.org/pub_display.php?pub_id=2305 (accessed January 26, 2005).
44 Dan Eggen, “Drugmakers Fight Plan to Allow Drug Reimportation,” Washington Post, December 15, 2009.
45 Huffington Post, “The Worst Drug Company Marketing Techniques,” March 18, 2010, http://www.huffingtonpost.com/2009/11/11/the-worst-drug-company-ma_n_353709.html.
46 Ben Hirschler, “Heart Expert Says Cost Cuts May Undermine Drug R&D,” Reuters News Service, August 28, 2010, http://www.reuters.com/article/idUSTRE67R0Tl20100828 (accessed November 22, 2010).
47 “Scientists are also working to thwart the potential devastation of biological warfare agents. Ten separate treatments for anthrax and three for smallpox are in development. Although medical progress eradicated naturally occurring smallpox in humans worldwide by 1980, concerns remain that the virus could be used as a bioterrorism weapon”: “Nearly 400 Medicines and Vaccines in Development to Fight Infectious Diseases,” Pharmaceutical Research and Manufacturers of America press release (Boston: September 10, 2010), http://www.phrma.org/news/news/
nearly_400_medicines_and_vaccines_development_fight_infectious_diseases (accessed November 7, 2010).
48 Louis J. Currat, 10/90 Report on Health Research 2003–2004, Global Forum for Health Research, www.globalforumhealth.org (accessed June 28, 2010). Since the Commission on Health Research for Development identified this “10/90 gap,” constant advocacy has resulted in improvements in funding, and the epidemiology of diseases has shifted substantially, so that even though a dramatic imbalance remains between the developing world’s medical problems and the resources devoted to them, objective studies, when they are performed, may well show some improvement in these numbers.
49 Fortune 500, “Most Profitable Industries: Our Ranking of America’s Largest Corporations, 2010,” May 3, 2010, http://money.cnn.com/magazines/fortune/fortune500/2010/
industries/21/index.html.
50 Public Citizen, 2002 Drug Industry Profits: Hefty Pharmaceutical Company Margins Dwarf Other Industries (Washington, D.C.: Public Citizen’s Congress Watch, June 2003), http://www.citizen.org/documents/Pharma_Report.pdf.
51 Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study (Washington, D.C.: Federal Trade Commission, July 2002), 57, http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf.
52 Plavix is Sanofi’s version of clopidogrel bisulfate, which was marketed by Bristol-Myers Squibb in the United States.
53 Federal Trade Commission, et al. v. Watson Pharmaceuticals, Inc., et al., CV-09–00598 (January 27, 2009), FTC File No. 0710060.
54 Federal Trade Commission, et al. v. Watson Pharmaceuticals, Inc., et al. (“Generic Androgel”), CV-09–00598 (civil complaint filed in U.S. District Court for the Central District of California, January 27, 2009), FTC File No. 0710060.
55 Hoechst Marion Roussel, Inc./Carderm Capital L.P./Andrx Corp., 131 F.T.C. 927 (2001).
56 Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study, 24, http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf.
57 Federal Trade Commission, Bureau of Competition, Health Care Division, Overview of FTC Antitrust Actions in Pharmaceutical Services and Products (Washington, D.C.: Federal Trade Commission, June 2010), http://www.ftc.gov/bc/0610rxupdate.pdf.
58 Safet Metjahhic, “Delaying Generic Drugs: The Legal Landscape Surrounding Reverse Payment Agreements to Protect Patent Holders,” New York Intellectual Property Law Association Bulletin (February–March 2010): 10–11.
59 Martin A. Voet, The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management, 2nd electronic ed. (Boca Raton, FL: Brown Walker Press, 2008), 12–19.
60 Kathleen Jaeger, president and CEO, Generic Pharmaceutical Association, “Proposed Free Trade Agreement with Malaysia,” Testimony before the Office of the United States Trade Representative and the Interagency Trade Policy Staff Committee, Washington, D.C., May 3, 2006.
61 T. W. Solomons and Craig Fryhle, Organic Chemistry, 8th ed. (Hoboken, NJ: Wiley, 2003), 208, 214.
62 Goozner, The $800 Million Dollar Pill, 221, 246.
63 Dirk Van Duppern, “The Cost of the Newest Cancer Drugs,” The Lancet 370, no. 9584 (July 2007): 317.
64 Gardiner Harris, “Prilosec’s Maker Switches Users to Nexium, Thwarting Generics,” Wall Street Journal, June 6, 2002.
65 Goozner, The $800 Million Dollar Pill, 214.
66 James Netterwald, PhD, “Recycling Existing Drugs,” Drug Discovery & Development, January 1, 2008.
67 Sidney M. Wolfe, MD, Public Citizen’s Health Research Group, “Congressional Testimony on FDA Deficiences,” Testimony before the Congressional Agriculture–FDA Appropriations Subcommittee Hearing on Drug Safety, February 27, 2008, http://www.citizen.org/hrg1835. Also, in a comment on the Slashdot Blog post “Patent Examiners Flee the USPTO,” reader “Doctor-Phil” wrote that “Patent examiners are under continual pressure to approve patents. We all have quotas set by our payscale and by the area in which we work and failure to meet the quotas results in being fired”: Doctor-Phil, Friday, July 29, 2005 (2:18 pm), comment on Slashdot Blog, “Patent Examiners Flee the USPTO,” Friday, July 29, 2005, http://yro.slashdot.org/story/05/07/29/1230256/Patent-Examiners-Flee-USPTO.
68 Lynne Taylor, “EU Single Patent ‘Breakthrough,’ ” Pharma Times, December 8, 2009, http://www.pharmatimes.com/Article/09-12-08/EU_single_patent_%E2%80%9Cbreakthrough%E2%80%9D.aspx.
69 Steve Connor, “Your Life in Their Patent,” The Independent, December 1, 1994.
70 Jane Zhang, “Battle Erupts over Disclosure on Drug Prices,” Wall Street Journal, August 19, 2006, p. A6, http://online.wsj.com/article/SB125064608529842021.html (accessed September 1, 2009).
71 Ibid.
72 Ibid.
73 “You have called for a war against cancer to find the cures that, in our lifetimes, will put an end to cancer, just as we once managed to put polio behind us”: Billy Tauzin, “Conversation with the President,” Annual Meeting of the Pharmaceutical Research and Manufacturers of America, San Antonio, TX, April 4, 2009, http://www.phrma.org/news_room/speeches/conversation_with_the_president (accessed November 17, 2010).
74 Frank R. Lichtenberg, Why Has Longevity Increased More in Some States Than in Others? The Role of Medical Innovation and Other Factors, Medical Progress Report no. 4 (New York: Manhattan Institute, July 2007), http://www.manhattan-institute.org/html/mpr_04.htm.
75 Dean Baker, PhD, and Adriane Fugh-Berman, MD, “Do New Drugs Increase Life Expectancy? A Critique of a Manhattan Institute Paper,” Journal of General Internal Medicine 24, no. 5 (2009): 678–82.
76 Ibid.
77 ALLHAT Website, http://allhat.sph.uth.tmc.edu/.
78 ALLHAT Officers and Coordinators, “Diuretic Versus α-Blocker as First-Step Antihypertensive Therapy: Final Results from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT),” Hypertension 42, no. 3 (2003): 239–46.
79 R. S. Keefe, R. M. Bilder, S. M. Davis, et al., “Neurocognitive Effects of Antipsychotic Medications in Patients with Chronic Schizophrenia in the CATIE Trial,” Archives of General Psychiatry 64, no. 6 (2007): 633–47.
80 Joel Lexchin, “Are New Drugs as Good as They Claim to Be?” Australian Prescriber 27, no. 2 (2004): 3, http://www.australianprescriber.com/magazine/27/1/2/3/ (accessed March 22, 2011).
1 “Progen’s First U.S. Clinical Trial with PI-88 Begins,” Worldwide Biotech/Entrepreneur Magazine, September 1, 2001, http://www.entrepreneur.com/tradejournals/article/77298877.html (accessed March 17, 2011).
2 J. A. Joyce et al., “A Functional Heparan Sulfate Mimetic Implicates Both Heparanase and Heparan Sulfate in Tumor Angiogenesis and Invasion in a Mouse Model of Multistage Cancer,” Oncogene 24, no. 25 (June 2005): 4037–51.
3 “Progen Technology Switches on Cancer Fighting Genes and Inhibits Tumor Growth,” Progen Pharmaceuticals Ltd., press release (Queensland, Australia, April 20, 2009), http://www.progen.com.au/Docs/prs/AACR_2009 _announcement_v3.pdf (accessed April 21, 2009).
4 Ahmedin Jemal, DVM, PhD, Freddie Bray, PhD, Melissa M. Center, MPH, et al., “Global Cancer Statistics,” CA: A Cancer Journal for Clinicians 61, no. 2 (February 4, 2011): 69–70, http://caonline.amcancersoc.org/cgi/content/full/caac.20107v1 (accessed March 17, 2011).
5 PI-88 has since been dubbed Muparfostat.
6 G. M. Keating and A. Santoro, “Sorafenib: A Review of Its Use in Advanced Hepatocellular Carcinoma,” Drugs 69, no. 2 (2009): 223–40, http://adisonline.com/drugs/abstract/2009/69020/
Sorafenib_A_Review_of_Its_Use_in_Advanced.6.aspx (accessed May 1, 2010).
7 BBC News, “Liver Drug Too Expensive,” November 19, 2009, http://news.bbc.co.uk/2/hi/health/8367614.stm.
8 Nyssa Skilton, “Drug Companies ‘Must Be Forced’ to Help the Public,” Canberra Times, December 16, 2008.
9 “Progen Pharmaceuticals Ltd signs Muparfostat (PI-88) non-binding Letter of Intent for License and Collaboration with Medigen Biotech Corp,” Progen Pharmacueticals Ltd., press release (Queensland, Australia, April 30, 2010), http://www.progen.com.au/Docs/prs/LOI%20Medigen%20Biotech%20Corp.pdf (accessed March 17, 2011).
10 Nyssa Skilton, “Science of Stymied Research,” Canberra Times, January 3, 2009.
11 Pharmaceutical Research and Manufacturers of America, “Inside Innovation: The Drug Discovery Process.”
12 Fortune 500, “Global 500: Our Ranking of the World’s Largest Corporations,” July 21, 2008, http://money.cnn.com/magazines/fortune/global500/2008/index.html.
13 Tom Blackwell, “Ontario Hospital Sued by Bayer,” National Post, August 16, 2007.
14 “Regional Named in Patent Infringement Lawsuit,” Chronicle-Journal, August 25, 2007, http://www.chroniclejournal.com/content/news/local/2007/08/25/regional-named-patent-infringement-lawsuit.
15 According to research firm IMS Health Canada: Blackwell, “Ontario Hospital Sued by Bayer.”
16 According to E. Richard Gold, director of McGill University’s Centre for Intellectual Property Policy, telephone interview with the author, July 9, 2009.
17 Bayer Healthcare AG et al. v. Thunder Bay Regional Health Sciences Centre, 2009, Ottawa Docket Summary, Summary of T-1450-07 Patent Infringement, December 17, 2009.
18 The Roche Group, “Roche and Genentech Reach a Friendly Agreement.”
19 “As of 21 February 2010, worldwide more than 213 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 16226 deaths”: Global Alert and Response, World Health Organization, “Update 89,” Pandemic (H1N1) 2009, February 26, 2010, http://www.who.int/csr/don/2010_02_26/en/index.htm (accessed February 27, 2010).
20 Paul Elias, “Race to Patent SARS Virus Renews Debate,” Associated Press Newsfeed, May 5, 2003, http://cmbi.bjmu.edu.cn/news/0305/63.htm.
21 “How Many Genes Are in the Human Genome?” Human Genome Project Information, Biological and Environmental Research Information System, U.S. Department of Energy, September 19, 2008, http://www.ornl.gov/sci/techresources/Human_Genome/faq/
genenumber.shtml.
22 Jamie Shreeve, “The Blueprint of Life,” U.S. News & World Report, October 1, 2005, http://www.usnews.com/usnews/news/articles/051031/31genome.htm (accessed March 16, 2011).
23 Faren Clum, “The Human Genome Project vs. Celera Genomics,” The Human Genome Project: A Brief History, ed. Huntington Outreach Project for Education at Stanford, December 6, 2008, http://hopes.stanford.edu/n3439/hd-genetics/human-genome-project.
24 Matthew Rimmer, “The Race to Patent the SARS Virus: The TRIPS Agreement and Access to Essential Medicines,” Melbourne Journal of International Law 5, no. 2 (October 2004): 335–74.
25 World Health Organization, Media Center, “Fact Sheet No. 259: African Trypanosomiasis (Sleeping Sickness),” October 2010, http://www.who.int/mediacentre/factsheets/fs259/en/.
26 “The Estimated Number of Actual Cases Was Between 50 000 and 70 000”: Ibid.
27 African trypanosomiasis is confined mainly to tropical Africa between 15 degrees North and 20 degrees South latitude: Ibid.
28 Ibid.
29 Richard D. Pearson, MD, “African Trypanosomiasis (African Sleeping Sickness),” in The Merck Manual (Whitehouse Station, NJ: Merck & Co., Inc., December 2009), http://www.merckmanuals.com/professional/sec14/ch186/ch186b.html (accessed March 16, 2011).
30 David C. Dugdale III, MD, Jatin M. Vyas, MD, PhD, and David Zieve, MD, MHA, “Sleeping Sickness,” Medline Plus, ed. National Institutes of Health, U.S. National Library of Medicine, December 3, 2008, http://www.nlm.nih.gov/medlineplus/ency/article/001362.htm.
31 Ann G. Sjoerdsma, Starting with Serotonin: How a High-Rolling Father of Drug Discovery Repeatedly Beat the Odds (Alexandria, VA: Improbable Books, 2008).
32 Institute of Medicine, Saving Lives, Buying Time: Economics of Malaria Drugs in an Age of Resistance, ed. Kenneth J. Arrow, Claire B. Panosian, and Hellen Gelband (Washington, D.C.: National Academies Press, 2004).
33 The quote is not verbatim. We know that Schechter gave his immediate assent but do not know with what words he agreed to provide eflornithine to Van Nieuwenhove: Sjoerdsma, Starting with Serotonin, chapter 26.
34 S. Van Nieuwenhove, P. J. Schechter, J. Declercq, et al., “Treatment of Gambiense Sleeping Sickness in the Sudan with Oral DFMO (DL-alfa-difluoromethylornithine), an Inhibitor of Ornithine Decarboxylase; First Field Trial,” Transactions of the Royal Society of Tropical Medicine and Hygiene 79, no. 5 (1985): 692–98.
35 David Greenwood, Antimicrobial Drugs: Chronicle of a Twentieth-Century Medical Triumph (New York: Oxford University Press, 2008), 284.
36 “Supply of Sleeping Sickness Drugs Secured,” Doctors Without Borders/Médecins Sans Frontières press release (Geneva, May 3, 2001), http://www.doctorswithoutborders.org/press/release.cfm?id=677.
37 “It took years of international pressure to find a solution to restart the production of the life-saving drug. This coincided with the media attention around the launch of Bristol-Myers Squibb’s (BMS) Vaniqa, an eflornithine-based product intended to remove women’s facial hair”: Ibid.
38 Duncan Mboyah, “Kenya to Be Declared Sleeping Sickness Free,” Coastweek.com, February 25, 2011, http://www.coastweek.com/xin_250211_06.htm (accessed March 22, 2011).
39 “Skin Medica Pharmaceuticals,” website, http://pharmaceuticals.skinmedica.com/vaniqa.
40 Ed Silverman, “Pfizer Buys Rights to Drug to Fix a Curved Penis,” Pharmalot, December 18, 2008, www.pharmalot.com/2008/12/Pfizer-Buys-Rights-to-a-Drug (accessed January 3, 2009).
41 “Erectile dysfunction, or ED, can be a total inability to achieve erection, an inconsistent ability to do so, or a tendency to sustain only brief erections. These variations make defining ED and estimating its incidence difficult”: “Erectile Dysfunction,” National Kidney and Urologic Diseases Information Clearinghouse, National Institute of Diabetes and Digestive and Kidney Diseases (Washington, D.C.: NIH Publication No. 06-3923, December 2005).
42 Natasha Singer, “Sure, It’s Treatable. But Is It a Disorder?” New York Times, December 12, 2009.
43 Avery Johnson, “J&J’s Prozac Cousin Approved Overseas, but Not for Depression,” Health Blog/Wall Street Journal, February 10, 2009, http://blogs.wsj.com/health/2009/02/10/jjs-prozac-cousin-approved-overseas-but-not-for-depression (accessed March 16, 2011).
44 Diana Samuels, “Bush’s ‘PEPFAR’ AIDS Treatment Program Saved a Million Lives in Africa, Stanford Researchers Say,” San Jose Mercury News, April 6, 2009, http://www.mercurynews.com/breakingnews/ci_12087859 (accessed April 7, 2009).
45 His name has been changed.
46 At least two drugs against hepatitis C, Vertex’s drug telaprevir and Merck’s boceprevir, are waiting in the wings, but they have yet to be tested in clinical trials or for FDA approval: Ewen Callaway, “Boost for Drugs Against Hepatitis C,” NatureNews, August 13, 2010, http://www.nature.com/news/2010/100813/full/news.2010.408.html (accessed September 7, 2010).
47 Harriet A. Washington, Living Healthy with Hepatitis C (New York: Dell, 2000).
48 Chiron’s pertinent European patents for hepatitis C virus (HCV) blood-screening assays are European patent No. 0 318 216; in the UK, the patent is GB 2,212,511: Daniel Raymond, “Chiron’s Hepatitis C Patents,” The Hepatitis C Harm Reduction Project, June 22, 2004, http://hepcproject.typepad.com/hep_c_project/2004/06/chirons_hepatit.html.
49 Murex’s test costs 30p; Chiron’s costs £2, more than six times as much.
50 Connor, “Your Life in Their Patent.”
51 Denise Gellene, “Chiron Relaxes Patent Licenses: The Biotech Firm Acts amid Criticism that Its Upfront Fees Stifle Work on Drugs for Hepatitis C,” Los Angeles Times, June 22, 2004, http://www.latimes.com/technology/la-fi-chiron22jun22,1,7764351.story?coll=la-headlines-technology.
52 In an unusual departure from nomenclature conventions, the gene symbol (HFE, for High Fe [iron]) is not an abbreviation of the official disease name, hemochromatosis.
53 “Classic Hemochromatosis (HFE), an Autosomal Recessive Disorder, Is Most Often Caused by Mutation in a Gene Designated HFE on Chromosome 6p21.3”: “HEMOCHROMATOSIS; HFE,” Online Mendelian Inheritance in Man, ed. Ada Hamosh, MD (Baltimore: McKusick-Nathans Institute of Genetic Medicine, Johns Hopkins University School of Medicine, November 3, 2010), http://www.ncbi.nlm.nih.gov/omim/235200 (accessed August 23, 2009).
54 David Blumenthal et al., “Withholding Research Results in Academic Life Science: Evidence from a National Survey of Faculty,” Journal of the American Medical Association 277, no. 15 (1997): 1224–28; Aaron S. Kesselheim, MD, JD, and Michelle M. Mello, JD, PhD, “Medical Process Patents Monopolizing the Delivery of Health Care,” New England Journal of Medicine 355, no. 9 (2006): 2036–41.
55 “Genes: HFE,” Genetics Home Reference: Understanding Genetic Conditions, The National Library of Medicine, http://ghr.nlm.nih.gov/gene/HFE (accessed March 22, 2011).
56 Jon F. Merz, Antigone G. Kriss, Debra G. B. Leonard, and Mildred K. Cho, “Diagnostic Testing Fails the Test,” Nature 415 (February 7, 2002): 577–79.
57 M. E. Cogswell et al., “Screening for Hemochromatosis: A Public Health Perspective,” American Journal of Preventive Medicine 16, no. 2 (February 1999): 134–40.
58 “Although the condition is genetic, it is usually not inherited: Only about 1 in 10 affected infants inherits the gene from his parents. The gene mutation usually arises during development in infants born to unaffected parents”: “SCN1A Epilepsy Gene Test: Diagnostic Advances for Managing Patients with Seizures,” Genetic Technologies Corporation Pty. Ltd., July 2005, www.gtmedical.com.au/resource/Clinician_Epilepsy_broch2.pdf (accessed November 18, 2010).
59 Julie Robotham, “Sick Babies Denied Treatment in DNA Row,” Sidney Morning Herald, November 29, 2008.
60 Anne Zieger, “DNA Patent Threatens Infant Healthcare in Australia,” Sydney Morning Herald, December 3, 2008.
61 W. F. Lloyd, Two Lectures on the Checks to Population (excerpt), in Population, Evolution, and Birth Control, ed. G. Hardin (San Francisco: Freeman, 1964), 37.
62 Alfred North Whitehead, Science and the Modern World (New York: Free Press, 1997), 10–11.
63 Wesley M. Cohen and Steven Merrill, eds., Patents in the Knowledge-Based Economy, Committee on Intellectual Property Rights in the Knowledge-Based Economy, National Research Council (Washington, D.C.: National Academies Press, 2003), 287–88.
64 Daniel J. DeNoon, “Pharmacies Can Still Make Preterm Birth Drug: Generic Versions of Makena Will Not Be Banned, FDA Says,” WebMD Health News website, March 30, 2011.
65 “Preemie Outrage: Cost of Drug That Prevents Premature Birth to Rise from $10 to $1500,” Daily Mail Reporter, March 9, 2011, 8.
66 Marc Iskowitz, “More Blockbusters Exit as Fosamax, Advair Go Off-Patent,” Medical Marketing and Media 43, no. 5 (March 2008): 363.
67 Kathy Method, “Going Going Gone: Patents Set to Expire Soon on Many Brand-Name Drugs,” DrugTopics Supplements, August 10, 2009, http://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?
id=617015&pageID=1&sk=&date.
68 Megan Ogilvie, “Secrecy Slowing Drug Research; Leading Scientist Urges Transparency to Deliver Drugs to Patients Sooner,” Toronto Star, April 4, 2009.
69 Tom Ramstack, “Patent Bill Seen Hurting Little Guy,” Washington Times, July 19, 2007.
70 Stephen Schondelmeyer, telephone interview with author, April 7, 2009.
71 Stephen W. Schondelmeyer, PharmD, PhD, “Patent Extensions of Pipeline Drugs: Impact on U.S. Health Care Expenditures” (Minneapolis: PRIME Institute, College of Pharmacy, University of Minnesota, July 1999).
72 Gina Chon, Damna Cimilluca, and Jeanne Whalen, “Sanofi Unveils Genzyme ‘Bear Hug,’ ” Wall Street Journal, August 30, 2010.
73 Alex Roland, “A Laboratory and Licensing; Committees and Engines, 1915–1918,” SP-4103 Model Research, vol. 1 (Washington, D.C.: Business, National Aeronautics and Space Administration Scientific and Technical Information Branch, 1985), http://history.nasa.gov/SP-4103/ch2.htm (accessed December 8, 2010).
74 Jeanne Clark, Joe Piccolo, Brian Stanton, and Karin Tyson, Patent Pools: A Solution to the Problem of Access in Biotechnology Patents? (Washington, D.C.: United States Patent and Trademark Office, December 5, 2000), http://www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf (accessed September 2010).
75 Rebecca Eisenberg and Michael A. Heller, “Can Patents Deter Innovation? The Anticommons in Biomedical Research,” Science 280, no. 5364 (1998): 698–701.
76 Mark Nance et al., “Patent Litigation: Is It Worth the Expense?” Genetic Engineering & Biotechnology News 26, No. 7 (2006), http://www.genengnews.com/gen-articles/patent-litigation-is-it-worth-the-expense/1454/ (accessed March 22, 2011).
77 Cohen and Merrill, Patents in the Knowledge-Based Economy.
1 Gardiner Harris and Benedict Carey, “Researchers Fail to Reveal Full Drug Pay,” New York Times, June 8, 2008, http://www.nytimes.com/2008/06/08/us/08conflict.html.
2 Rita Rubin, “FDA Panel to Vote on Antipsychotic Drugs for Kids,” USA Today, June 9, 2009.
3 Martha Rosenberg, “Parents Fight Use of New Psych Meds for Kids,” San Francisco Chronicle, September 13, 2009.
4 Duff Wilson, “Child’s Ordeal Shows Risks of Psychosis Drugs for Young,” New York Times, September 1, 2010.
5 Gardiner Harris, “Drug Maker Told Studies Would Aid It, Papers Say,” New York Times, March 19, 2009.
6 “ADHD is a problem with inattentiveness, over-activity, impulsivity, or a combination. For these problems to be diagnosed as ADHD, they must be out of the normal range for the child’s age and development”: Brandon Keim, “Could Antidepressants Rewire Adolescent Brains?” Wired Science, Wired, May 30, 2009, http://www.wired.com/wiredscience/2007/05/could_antidepre/ (accessed August 4, 2009).
7 Gardiner Harris, “Research Center Tied to Drug Company,” New York Times, November 24, 2008.
8 “The rationale of this center,” Johnson & Johnson internal documents stated, “is to generate and disseminate data supporting the use of risperidone [Risperdal] in children and adolescents.” Ibid.
9 Ibid.
10 The Best Pharmaceuticals for Children Act of 2002 (BPCA) renewed our authority to grant six months of additional marketing exclusivity to manufacturers who conduct and submit pediatric studies in response to our written requests. Best Pharmaceuticals for Children Act, January 4, 2002 (Public Law 107-109), http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
DevelopmentResources/ucm049876.htm.
11 Xi Yu, “Three Professors Face Sanctions Following Harvard Medical School Inquiry,” Harvard Crimson, July 2, 2011.
12 “Letter from Joseph Biederman, Thomas J. Spencer, and Timothy E. Wilens,” July 1, 2011.
13 The Infinite Mind, “The Bipolar Child,” LCMedia original broadcast, September 20, 2005, http://www.lcmedia.com/mind133.htm.
14 Gardiner Harris, “Radio Host Has Drug Company Ties,” New York Times, November 21, 2008.
15 Natalie Angier, “Disputed Meeting to Ask If Crime Has Genetic Roots,” New York Times, September 19, 1995.
16 Warren E. Leary, “Struggle Continues Over Remarks by Mental Health Official,” New York Times, March 8, 1992.
17 Certain tenets of the U.S. Code of Federal Regulations (CFR 21 50.23 and 50.24) allow research to be conducted in trauma emergencies or in some national-defense situations without the subjects’ knowledge or permission.
18 Carl Elliott, White Coat, Black Hat: Adventures on the Dark Side of Medicine (Kindle version) (Boston: Beacon Press, 2010), 43.
19 National Academy of Science, Institute of Medicine, Board on Population Health, The Future of Drug Safety: Promoting and Protecting the Health of the Public (Washington, D.C.: The National Academies, September 22, 2006), http://www.iom.edu/Reports/2006/The-Future-of-Drug-Safety-Promoting-and-Protecting-the-Health-of-the-Public.aspx.
20 Ibid.; Diedtra Henderson, “Report: FDA Needs More Authority, Funds,” Boston Globe, September 23, 2006.
21 Melody Peterson, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (New York: Farrar, Straus & Giroux, 2008).
22 “Testimony of David J. Graham, MD, MPH, November 18, 2004,” to the United States Senate Committee on Finance, Thursday, November 18, 2004, 10:00 A.M., 216 Hart Senate Office Building.
23 Ben Goldacre, “The danger of drugs … and data,” Guardian, May 9, 2009.
24 Matthew Herper, “The FDA Ignores Its Advisors a Quarter of the Time,” The Medicine Show Blog, Forbes, October 12, 2010, http://blogs.forbes.com/matthewherper/2010/10/12/the-fda-ignores-its-advisors-a-quarter-of-the-time/.
25 Peter Lurie, MD, MPH, and Sidney M. Wolfe, MD, “FDA Medical Officers Report Lower Standards Permit Dangerous Drug Approvals,” Public Citizen, December 2, 1998, http://www.citizen.org/hrg1466; Wolfe, “Congressional Testimony on FDA Deficiences.”
26 Ibid.
27 David Willman, “The Rise and Fall of the Killer Drug Rezulin,” Los Angeles Times, June 4, 2000.
28 David Willman, “Strategy Developed to Get Latinos ‘to Take the Risk,’ ” Los Angeles Times, June 30, 2002, http://articles.latimes.com/2002/jun/30/nation/na-rezside30.
29 David Willman, “Diabetes Drug Rezulin Pulled Off the Market,” Los Angeles Times, March 22, 2000.
30 S. E. Nissen and K. Wolski, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes,” New England Journal of Medicine 356, no. 24 (2007): 2457–71; Bruce M. Psaty, MD, PhD, and Curt D. Furberg, MD, PhD, “Rosiglitazone and Cardiovascular Risk,” New England Journal of Medicine 356, no. 24 (2007): 2522–24.
31 Brandon Keim, “Glaxo, Doctors Battle over Interpretation of New Avandia Study,” Wired Science, Wired, June 6, 2007, http://www.wired.com/wiredscience/2007/06/glaxo_doctors_b (accessed March 23, 2011).
32 Juhi Yajnik, “University Sues Pfizer over COX-2 Research,” The Scientist, October 27, 2006, http://www.the-scientist.com/news/display/25408/ (accessed April 29, 2011).
33 W. L. Xie, J. G. Chipman, D. L. Robertson, R. L. Erikson, and D. L. Simmons, “Expression of a Mitogen-Responsive Gene Encoding Prostaglandin Synthase Is Regulated by mRNA Splicing,” Proceedings of the National Academy of Sciences 88, no. 7 (April 1991): 12692–96.
34 Tom Harvey, “BYU Spices Up Celebrex Lawsuit Against Pfizer,” Salt Lake Tribune, September 21, 2010, http://www.sltrib.com/sltrib/money/49883490-79/byu-pfizer-simmons-celebrex.html.csp (accessed May 12, 2011).
35 Although children under eighteen are discouraged from taking aspirin to avoid the very rare Reye’s syndrome that can attack the liver and brain in the wake of the flu or other viral illness, and although high doses of ibuprofen have been linked to higher stroke risks for the elderly, most people can find an over-the-counter NSAID that offers them effective, safe pain relief.
36 A 100-pill bottle of Walgreens generic aspirin, for example, can be bought for $1, or $.01 a pill. Vioxx costs $396 for 50 pills, or $7.92 a pill: 792 times the price of the aspirin. Insurance coverage hides the true costs of prescription medications from most of us.
37 J. M. Wright, “The Double-Edged Sword of COX-2 Selective NSAIDs,” Canadian Medical Association Journal 167, no. 10 (2002): 1131–37.
38 “CELEBREX® (Celecoxib) Capsules, G. D. Searle & Co.,” Physicians’ Desk Reference (Montvale, NJ: PDR Network, LLC, 2010), http://www.pdr.net/drugpages/productlabeling.aspx?mpcode=76000300 (accessed November 20, 2010).
39 Barry Meier, Gina Kolata, and Andrew Pollack, “Medicine Fueled by Marketing Intensified Trouble for Pain Pills,” New York Times, December 19, 2004.
40 Drew Griffin and Andy Segal, “Feds Found Pfizer Too Big to Nail,” CNN.com Health, CNN, April 02, 2010, http://articles.cnn.com/2010-04-02/health/pfizer.bextra_1_bextra-pfizer-and-pharmacia-generic-drugs?_s=PM:HEALTH.
41 This is an abbreviation for qui tam pro domino rege quam pro se ipso in hac parte sequitur, which means “one who sues in this matter for the king as well as on behalf of himself.”
42 Bill Berkrot, “Pfizer Whistleblower’s Ordeal Reaps Big Rewards,” Reuters, September 3, 2009, www.reuters.com/article/businessNews/idUSN021592920090903 (accessed September 7, 2009).
43 “Justice Department Announces Largest Health Care Fraud Settlement in Its History,” Department of Health and Human Services, press release (Washington, D.C., September 2, 2009), http://www.hhs.gov/news/press/2009pres/09/20090902a.html.
44 Gardiner Harris, “Pfizer Pays $2.3 Billion to Settle Marketing Case,” New York Times, September 3, 2009.
45 Carrie Johnson, “In Settlement, a Warning to Drugmakers: Pfizer to Pay Record Penalty in Improper-Marketing Case,” Washington Post, September 3, 2009.
46 F. E. Silverstein, G. Faich, J. L. Goldstein, et al., “Gastrointestinal Toxicity with Celecoxib vs Nonsteroidal Anti-Inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial. Celecoxib Long-Term Arthritis Safety Study,” Journal of the American Medical Association 284, no. 10 (September 2000): 1247–55; C. Bombardier, L. Laine, A. Reicin, et al., “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis. VIGOR Study Group,” New England Journal of Medicine 343, no. 21 (November 2000): 1520–28.
47 Richard Knox, “Merck Pulls Arthritis Drug Vioxx from Market,” All Things Considered, September 30, 2004, http://www.npr.org/templates/story/story.php?storyId=4054991 (accessed November 20, 2010).
48 Ben Goldacre, “The Dangers of Drugs … and Data.”
49 Senator Charles Grassley, letter to Pfizer via electronic transmission, March 3, 2009, http://graphics8.nytimes.com/packages/pdf/business/
2009_03_03_Pfizer_letter.pdf.
50 They are Drs. Thomas Fleming (University of Washington), Curt Furberg (Wake Forest University), Steven Nissen (the Cleveland Clinic), and Alastair Wood (Vanderbilt University).
51 John McKenzie, “Medical Journal Changes Independent Policy,” abcnews.com, June 12, 2002, http://abcnews.go.com/WNT/story?id=130296&page=1.
52 Peter Gorner, “New England Journal of Medicine Eases Conflict-of-Interest Policy for Authors,” Chicago Tribune, June 13, 2002.
53 Adriane J. Fugh-Berman, “The Haunting of Medical Journals: How Ghostwriting Sold ‘HRT,’ ” PLoS Medicine 7, no. 9 (September 2010): e1000335, http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000335 (accessed November 20, 2010).
54 The Drug Industry Document Archive, a searchable database of drug-company documents, is available at http://dida.library.ucsf.edu.
55 Andrew P. Lea, DesignWrite, Inc., “RE: Premarin/TMG publication plan proposal,” email, May 20, 2003, http://dida.library.ucsf.edu/tid/duc37b10 (accessed November 21, 2010).
56 B. Janas, DesignWrite, Inc., “updated outline,” email, April 13, 2010, http://dida.library.ucsf.edu/pdf/boc37b10 (accessed August 21, 2009).
57 “Proposal for Jeff Solomon—Medical Education and Communication Plan for the Premarin Product Line,” DesignWrite, Inc., August 12, 1996, http://dida.library.ucsf.edu/pdf/jrb37b10 (accessed August 21, 2009).
58 “Bylined articles will allow us to fold Lexapro messages into articles on depression, anxiety and comorbidity developed by (or ghostwritten for) thought leaders”: Ibid.
59 Matthew Perrone, “Glaxo Used Ghostwriting Program to Promote Paxil,” Associated Press/Boston Globe, August 20, 2009.
60 Alicia Mundy, Dispensing with the Truth: The Victims, the Drug Companies, and the Dramatic Story behind the Battle over Fen-Phen (New York: St. Martin’s Press, 2001), 162–67.
61 C. Seth Landefeld and Michael A. Steinman, MD, “The Neurontin Legacy—Marketing through Misinformation and Manipulation,” New England Journal of Medicine 360, no. 2 (2009): 103–6.
62 David Healy, MD, FRCPsych, and Dinah Cattell, “Interface between Authorship, Industry and Science in the Domain of Therapeutics,” British Journal of Psychiatry 183 (2003): 22–27.
63 Joseph S. Ross, MD, MHS, Kevin P. Hill, MD, MHS, et al., “Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents from Rofecoxib Litigation,” Journal of the American Medical Association 299, no. 15 (2008): 1800–12.
64 “Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group,” Lancet 2, no. 8607 (1988): 349–60.
65 Peter Sleight, “Debate: Subgroup Analyses in Clinical Trials: Fun to Look At—but Don’t Believe Them!” Current Control Trials in Cardiovascular Medicine 1, no. 1 (2000): 25–27.
66 Jonathan D. Kahn, “How a Drug Becomes ‘Ethnic’: Law, Commerce, and the Production of Racial Categories in Medicine,” Yale Journal of Health Policy, Law, and Ethics 4, no. 1 (Winter 2004): 1–46.
67 “Although blacks and whites suffer the same rate of death from congestive heart failure, blacks tend to die earlier, which is unsurprising considering their well-documented lesser access to heart disease technology and other cardiac care and differences in diet, exercise and stress exposure”: Ibid.
68 Keith J. Winstein, “NAACP Presses US on Heart Drug,” Wall Street Journal, January 25, 2007.
69 “NitroMed was criticized for the drug’s high cost, which at $1.80 a pill (or $5.40 a day) equaled 4 to 7 times the price of generic isosorbide plus hydralazine”: Martha Lincoln, “Because You Want More Life to Live: BiDil, a Heart Failure Prescription for Self-Identified Blacks,” Corporations and Health Watch, May 1, 2008, http://www.corporationsandhealth.org/news/61/59/Because-You-Want-More-Life-to-Live-BiDil-a-Heart-Failure-Prescription-for-Self-Identified-Blacks (accessed December 20, 2010).
70 Jonathan Kahn, JD, PhD, “How a Drug Becomes ‘Ethnic’: Law, Commerce, and the Production of Racial Categories in Medicine,” Yale Journal of Health Policy, Law, and Ethics 4, no. 1 (2004); also see Kahn, “Getting the Numbers Right: Statistical Mischief and Racial Profiling in Heart Failure Research,” Perspectives in Biology and Medicine 46, no. 4 (Autumn 2003): 473–83.
71 Mary Ann Moon, “Industry Funded CV Trials—Biased to Positives?” Internal Medicine News, June 15, 2006, http://www.internalmedicinenews.com/index.php?id=2049&type=98&tx_ttnews[tt_news]=9824&cHash=da03e20e36 (accessed March 22, 2011).
72 Paul M. Ridker, MD, and Jose Torres, BA, “Reported Outcomes in Major Cardiovascular Clinical Trials Funded by For-Profit and Not-for-Profit Organizations: 2000–2005,” Journal of the American Medical Association 295, no. 19 (2006): 2270–74.
73 Cara Bouwer, “Sponsored Research Tends to Show Bias,” Business Day, June 13, 2007, 5.
74 Mark Henderson, “Drug Trials ‘Give Best Results to Sponsors,’ ” Sunday Times (London), June 5, 2007, http://www.timesonline.co.uk/tol/news/science/article1884627.ece.
75 David J. Sackett and Andrew D. Oxman, “HARLOT plc: An Amalgamation of the World’s Two Oldest Professions,” British Medical Journal 327, no. 7429 (2003): 1442–45.
76 Thoma M. Burton, “Despite Heart Attack Deaths, Polyheme Still Being Tested on Trauma Patients,” Wall Street Journal, February 22, 2006.
77 Merck & Co. sponsored ADVANTAGE (Assessment of Differences between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness). Kevin P. Hill, MD, MHS; Joseph S. Ross, MD, MHS; David S. Egilman, MD, MPH; and Harlan M. Krumholz, MD, SM, “The ADVANTAGE Seeding Trial: A Review of Internal Documents,” Annals of Internal Medicine 149, no. 4 (August 19, 2008): 251–58, http://www.annals.org/content/149/4/251.full.
78 Harold C. Sox and Drummond Rennie, “Seeding Trials: Just Say ‘No,’ ” Annals of Internal Medicine 149, no. 4 (August 2008): 279–80.
79 Richard Smith, “Medical Journals and Pharmaceutical Companies: Uneasy Bedfellows,” British Medical Journal 326 (2003): 1202.
80 Harriet A. Washington, “Flacking for Pharma: Big Pharmaceutical Companies Don’t Just Compromise Doctors; They Also Undermine the Top Medical Journals and Skew the Findings of Medical Research,” The American Scholar (Summer 2011): 2–14
81 Bob Grant, “Merck Published Fake Journal,” The Scientist, April 30, 2009, http://www.the-scientist.com/blog/display/55671/.
82 Ben Goldacre, “The Danger of Drugs … and Data.”
83 “Progressive Librarians Guild Calls for Elsevier to End Corrupt Publishing Practices and for Library Associations to Take Advocacy Role on Behalf of Scientific Integrity,” Progressive Librarians Guild news release (Lawrenceville, NJ, May 12, 2009), http://libr.org/plg/elsevier.php; Bob Grant, “Elsevier Published 6 Fake Journals,” The Scientist, May 7, 2009, http://www.the-scientist.com/blog/display/55679/.
84 Ben Goldacre, “The Danger of Drugs … and Data.”
85 Margaret Hunt, Virology, Chapter Thirteen: Influenza Virus (Orthomyxovirus), Microbiology and Immunology Online, http://pathmicro.med.sc.edu/mhunt/flu.htm.
86 D. J. Sencer and J. D. Millar, “Reflections on the 1976 Swine Flu Vaccination Program,” Emerging Infectious Diseases 12, no. 1 (January 2006), http://www.cdc.gov/ncidod/EID/vol12no01/05–1007.htm (accessed June 1, 2011).
87 Ibid.
88 Ibid.
89 Helen Epstein, “Flu Warning: Beware the Drug Companies!” New York Review of Books, May 12, 2011.
90 Helen Epstein, “Beware Tamiflu,” New York Review of Books, May 26, 2011.
91 Helen Epstein, “Flu Warning: Beware the Drug Companies!”
92 Ibid.
93 S. Vallet, A. Palumbo, N. Raje, et al., “Thalidomide and Lenalidomide: Mechanism-Based Potential Drug Combinations,” Leukemia & Lymphoma 49, no. 7 (2008): 1238–45.
94 AdisInsight, Wolters Kluwer Pharma Solutions, “Thalidomide” (800004827), March 15, 1995, http://bi.adisinsight.com/rdi/viewdocument.aspx?render =view&mode=remote&adnm=800004827&PushValidation=121745 (retrieved September 17, 2010).
95 “Thalidomide,” Center for the Evaluation of Risks to Human Reproduction, National Toxicology Program, Department of Health and Human Services, http://cerhr.niehs.nih.gov/common/thalidomide.html (accessed September 17, 2010).
96 “Against Leprosy,” Thalidomide, Föreningen för de Neurosedynskadad/The Swedish Thalidomide Society, http://www.thalidomide.org/web/against-leprosy/ (accessed September 17, 2010).
97 F. J. Paumgarten and I. Chahoud, “Thalidomide Embryopathy Cases in Brazil after 1965,” Reproductive Toxicology 22, no. 1 (2006): 1–2; “Thalidomide Scares Again/Talidomida volta a assustar,” Brazilian Department of Health press release (Rio de Janeiro, November 1, 2006), http://www.saude.df.gov.br/003/00301009.asp?ttCD_CHAVE=31041.
98 Seth W. Glickman, MD, MBA, et al., “Ethical and Scientific Implications of the Globalization of Clinical Research,” New England Journal of Medicine 360, no. 8 (February 2009): 816.
99 Michael Kremer, “Pharmaceuticals and the Developing World,” Journal of Economic Perspectives 16, no. 4 (2002): 67–90.
100 Phillip Knightley et al., Suffer the Children: The Story of Thalidomide (New York: Viking, 1979), 40–41.
1 “Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims,” posted by John Conley and Dan Vorhaus, Genomics Law Report, March 30, 2010, www.genomicslawreport.com/index.php/2010/03/30/pigs-fly-federal-court-invalidates-myriads-patent-claims/, accessed April 2, 2010.
2 Sharon Begley, “In Surprise Ruling, Court Declares Two Gene Patents Invalid,” Newsweek, March 29, 2010.
3 The BRCA genes, like other patented genes, are products of nature, but an artificial gene was first reported synthesized on June 2, 1970, by MIT professor Har Gobind Khorana, who was then a chemist at the University of Wisconsin (www.super70s.com/Super70s/Timeline/1970/ and www.answers.com/topic/har-gobind-khorana).
4 Atomic mass units, or daltons: this is a conventional, infinitesimal measure of matter on the atomic scale. 1 amu = 1.66 × 10–24 grams.
5 Under thirty-five years of age.
6 Esther John, Alexander Miron, Gail Gong, Amanda I. Phipps, Anna Felberg, Frederick P. Li, Dee W. West, and Alice S. Whittemore, “Prevalence of Pathogenic BRCA1 Mutation Carriers in 5 US Racial/Ethnic Groups,” Journal of the American Medical Association 298, no. 24 (October 2007): 2869–76.
7 Steve Benowitz, “French Challenge to BRCA1 Patent Underlies European Discontent,” Journal of the National Cancer Institute 94, no. 2 (January 2002): 80–81.
8 “Genetics,” Breastcancer.org, February 15, 2011, http://www.breastcancer.org/risk/factors/genetics.jsp, accessed March 9, 2011.
9 Association of Molecular Pathology et al. v. United States Patent and Trademark Office; Myriad Genetics et al. in United States District Court Southern District of New York, 26.
10 Myriad Genetics et al., 27–28.
11 American Intellectual Property Law Association, Report of Economic Survey (Arlington, VA: AIPLA, 1999), table 22.
12 Benowitz, “French Challenge to BRCA1.”
13 Karen van Kampen, “Owning the Code,” National Post Business Magazine, September 1, 2005, 56.
14 John Schwartz, “Cancer Patients Challenge the Patenting of a Gene,” New York Times, May 13, 2009.
15 NF-κB stands for nuclear factor kappa-light-chain-enhancer of activated B cells, a proteinaceous complex found in all nearly animal cells that governs the regulation of DNA transcription: A. R. Braiser, “The NF-κB regulatory network,” Cardiovascular Toxicology 6, no. 2 (2006): 111–30.
16 Charlotte Harrington, “News and Analysis: Patent Watch,” Nature Reviews Drug Discovery 9 (2010): 352–53, http://www.nature.com/nrd/journal/v9/n9/full/nrd3273.html (accessed March 9, 2011).
17 Sharon Begley, “In Surprise Ruling, Court Declares Two Gene Patents Invalid,” Newsweek, March 29, 2010, http://www.newsweek.com/blogs/the-human-condition/2010/03/29/in-surprise-ruling-court-declares-two-gene-patents-invalid.html (accessed June 23, 2011).
18 American Civil Liberties Union, “BRCA: Genes and Patents,” May 27, 2009, http://www.aclu.org/free-speech/brca–genes–and–patents (accessed May 2010).
19 Van Kampen, “Owning the Code,” 57.
20 Jeffery P. Struewing, Dvorah Abeliovich, Tamar Peretz, Naaman Avishai, Michael M. Kaback, Francis S. Collins, and Lawrence C. Brody, “The carrier frequency of the BRCA1 185delAG mutation is approximately 1 percent in Ashkenazi Jewish individuals,” Nature Genetics 11 (1995): 198–200.
21 “Against the monopoly of Myriad Genetics on tests of susceptibility to breast and ovarian cancer: role reversal of situation in the European patent office,” Institut Curie press release (Paris, November 20, 2008), http://www.curie.fr/sites/default/files/decision-OEB-Myriad-Genetics-predisposition-sein.pdf.
22 The organization is also known as the Committee for Prevention of Genetic Diseases, and has offices in Brooklyn and Israel.
23 Arthur Allen, “Who owns your DNA? Genetic research that can save lives is often stymied by biotech companies’ greedy patent claims,” Salon, March 7, 2000, http://www.salon.com/health/feature/2000/03/07/genetic_test/index.html (accessed November 1, 2010).
24 Greenberg, 264 F. Supp. 2d at 1069-70.
25 Radhika Rao, “Genes and Spleens: Property, Contract, or Privacy Rights in the Human Body?” Journal of Law Medicine Ethics 35, no. 3 (2007): 371–82.
26 Allen, “Who Owns Your DNA?”
27 “A survey of laboratories revealed a possible price premium for ASPA [Canavan’s] testing, with per-unit costs higher than for other genetic tests in the Secretary’s Advisory Committee on Genetics, Health, and Society Case Studies”: Alessandra Colaianni, Subhashini Chandrasekharan, and Robert Cook-Deegan, MD, “Impact of Gene Patents and Licensing Practices on Access to Genetic Testing and Carrier Screening for Tay-Sachs and Canavan Disease,” Genetics in Medicine 12, no. 4 (April 2010): S5-S14, http://journals.lww.com/geneticsinmedicine/Fulltext/2010/0400 (accessed July 19, 2010).
28 Ibid.
29 E. G. Campbell, B. R. Clarridge, M. Gokhale, L. Birembaum, S. Hilgartner, N. A. Holtzman, and D. Blumenthal, “Data Withholding in Academic Genetics: Evidence from a National Survey,” Journal of the American Medical Association 287, no. 4 (January 2002): 473–80.
30 Vida Foubister, “Gene Patents Raise Concerns for Researchers, Clinicians,” American Medical News, February 21, 2000, http://www.ama-assn.org/amednews/2000/02/21/prsb0221.htm (accessed March 23, 2011).
31 Julian Borger, “Gene Patents Hit Research,” Guardian, December 15, 1999.
32 Daniel Kevles, In the Name of Eugenics: Genetics and the Uses of Human Heredity (Cambridge, MA: Harvard University Press, 1998).
33 Finn Bowring, Science, Seeds, and Cyborgs: Biotechnology and the Appropriation of Life (London: Verso, 2003).
34 James Bowman, MD, personal interview on May 15, 2006; written communication, July 11, 2005, and September 14, 2007.
35 Kevles, In the Name of Eugenics.
36 Ibid.
37 The erroneous characterization of sickle-cell carriers or heterozygotes as “sick” is ironic because heterozygotes actually enjoy the medical advantage of increased resistance to malaria. Thus, heterozygotes are actually healthier than either homozygotes, who have sickle-cell disease, or people with two normal copies of the gene, who have no additional protection against malaria. In fact, in malarious areas such as West Africa, sickle-cell heterozygotes are 15 percent more likely than people without the HBB “sickle-cell gene” to survive and reproduce: this is called the “heterozygote advantage.”
38 Harriet A. Washington, Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present (New York: Doubleday, 2007), 310.
39 2007 Course Catalog, School of Aerospace Medicine, United States Air Force, 16, http://afspp.afms.mil/idc/groups/public/documents/afms/ctb_073557.pdf (accessed May 19, 2010).
40 Sharon F. Terry, “Learning Genetics,” Health Affairs 22, no. 5 (2003): 166–71.
41 Ibid., 171.
42 Justin Gillis, “Gene Research Success Spurs Profit Debate,” Washington Post, December 30, 2000.
1 Milete was given not blood but PolyHeme, which is red and resembles blood.
2 Jay Katz, MD, and Jos V. M. Welie, “Blurring the Lines: Research, Therapy, and IRBs (New FDA Regulations on Informed Consent and Emergency Research in Life-Threatening Situations),” Hastings Center Report 27, no. 1 (January–February 1997): 9–12.
3 G. L. Kierman, “Scientific and Ethical Considerations in the Use of Placebo Controls in Clinical Trials in Psychopharmacology,” Psychopharmacology Bulletin 22, no. 1 (1986): 25–29.
4 It “permits drug-by-drug waiver approval on the basis that consent is ‘not feasible’ in a specific military operation involving combat or the immediate threat of combat”: George J. Annas, “Protecting Soldiers from Friendly Fire: The Consent Requirement for Using Investigational Drugs and Vaccines in Combat,” American Journal of Law & Medicine 24, nos. 2–3 (1998): 245–60.
5 Chris Adams, “FDA Clears BioPort to Resume Shipments of Anthrax Vaccine,” Wall Street Journal, January 31, 2002. “In various follow-up visits by FDA inspectors, BioPort was cited for deficiencies in record-keeping, sterility precautions and manufacturing deviations.”
6 “Feres v. United States, 340 U.S. 135 (1950), is a case in which the Supreme Court of the United States ruled that the United States is not liable under the Federal Tort Claims Act for injuries to members of the armed forces sustained while on active duty and not on furlough and resulting from the negligence of others in the armed forces. The opinion is an extension of the English common-law concept of sovereign immunity”: Jennifer L’Hommedieu Stankus, JD, MS-4, “Understanding Medical Liability in Military Medicine,” American College of Emergency Physicians (ACEP)/ACEP News, February 2009, http://www.acep.org/content.aspx?id=43974.
7 Feres v. United States, 340 U.S. 135 (1950).
8 Preliminary Injunction, Doe v. Rumsfeld, Civil Action No. 03-707 (EGS), December 22, 2003, http://www.cbsnews.com/htdocs/pdf/anthraxdocument.pdf.
9 Doe v. Rumsfeld, 341 F. Supp. 2d 1, 6 (D.D.C. 2004); “Anthrax Vaccinations Halted Again,” United Press International, Military.com, October 28, 2004, http://www.military.com/NewsContent/0,13319,FL_anthrax_102804,00.html.
10 Doe v. Rumsfeld.
11 Marie McCullough, “Technical Difficulties Put Anthrax Vaccine out of Reach; Some Experts Said That May Be a Good Thing, in Part Because of Questions About Its Maker and the Inoculation Itself,” Philadelphia Inquirer, October 30, 2001, A10.
12 Stephen Kinzer, “A Nation Challenged: The Biological Threat; Military’s Sole Supplier of Anthrax Vaccine Still Can’t Make It,” New York Times, October 6, 2001, 1B.
13 Keith Epstein and Bill Sloat, “Drug Trials: Do People Know the Truth About Experiments?” Cleveland Plain Dealer, December 15, 1996.
14 Michelle H. Biros, MD, Annals of Emergency Medicine 42, no. 4 (October 2003): 550–64.
15 46 percent.
16 Hon. George M. Marovich, United States District Court, Northern District of Illinois Eastern Division. Memorandum Opinion and Order, in Re Northfield Laboratories, Inc. No. 06 C 1493 Securities Litigation, 2.
17 Charles Natanson, MD, Steven J. Kern, BS, Peter Lurie, MD, MPH, et al., “Cell-Free Hemoglobin-Based Blood Substitutes and the Risk of Myocardial Infarction and Death,” Journal of the American Medical Association 299, no. 19 (April 2008): 2304–12.
18 Northfield Laboratories, “PolyHeme Q&A,” in PolyHeme® Clinical Trial PowerPoint presentation, Wishard Health Services, January 21, 2004.
19 ABC-TV, “US Medical Experiments Without Consent?” World News with Charles Gibson, May 27, 2007, http://abcnews.go.com/WNT/Video/playerIndex?id=3217758 (accessed February 25, 2010).
20 www.Im4justice.com. This site seems to have been taken down in early 2010.
21 Matt Potter, “Bad Blood?” San Diego Reader, Thursday, July 28, 2005.
22 Eleven of the thirty-two original testing sites, or 34.4 percent.
23 All sixteen were subjects, but they were not all infused with PolyHeme; six were infused with saline, as controls.
24 “Study Patient Characteristics,” in PolyHeme® Trauma Trial PowerPoint presentation, slide 15, Methodist Hospital & Wishard Health Services.
25 The FDA also noted that “the safety data of all controlled studies reveal that the administration of PolyHeme places the patients at a higher risk of significant adverse events,” and stated that “therefore, in the absence of clinical benefit, the risk:benefit assessment of the product in trauma is unfavorable.”
26 Rob Stein, “Critical Care Without Consent: Ethicists Disagree on Experimenting During Crises,” Washington Post, May 27, 2007.
27 “Researchers Overwhelmed by ‘Opt Outs’ from No-Consent Medical Studies,” Seattle Times, June 7, 2007.
28 Myron Weisfeldt, MD, telephone interview with author, June 18, 2009.
29 Glenn McGee, PhD, “The Wonders of PolyHeme … by Press Release,” blog.bioethics.net, American Journal of Bioethics, January 9, 2009, http://blog.bioethics.net/2009/01/the-wonders-of-polyhemeby-press-release/.
30 When contacted through the JHU press office, Dr. Norris refused to speak with me.
31 Thomas M. Burton, “Amid Alarm Bells, a Blood Substitute Keeps Pumping,” Wall Street Journal, February 22, 2006.
32 Carl Elliott, “Not-So-Public Relations: How the Drug Industry Is Branding Itself with Bioethics,” Slate, December 15, 2003, http://www.slate.com/id/2092442 (accessed March 28, 2009).
1 “Ardais Corporation Announces Agreement with AstraZeneca for Access to Clinical Samples,” Ardais Corp. press release, PRNewswire, Lexington, MA, February 4, 2003.
2 Ibid.
3 Dan Holtzclaw, DDS, MS, Nicholas Toscano, DDS, MS, Lisa Eisenlohr, PhD, et al., “The Safety of Bone Allografts Used in Dentistry: A Review,” Journal of the American Dental Association 139, no. 9 (2008): 1192–99.
4 David Hinckley, “Boss of Notorious Body Snatching Ring Gets 54 Years for Harvesting,” New York Daily News, March 19, 2008.
5 BBC News, “Plea Deal in US Body Parts Case,” January 16, 2008, http://news.bbc.co.uk/2/hi/americas/7192462.stm.
6 Genomics is a relatively new scientific discipline whose ambition is to identify pathogenic genes and then improve life and health by creating drugs that will target and nullify the effects of these troublemaking genes.
7 Deborah Josefson, “US Hospitals to Ask Patients for Right to Sell Their Tissue,” British Medical Journal 321, no. 7262 (2000): 658.
8 Moore v. Regents of University of California, 51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479 (1990).
9 Josefson, “US Hospitals to Ask Patients for Right to Sell Their Tissue.”
10 Anne Paxton, “Brisk Trade in Tissue for Proteomics and Genomics Research,” CAP Today, March 2003, http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=cap_today%2Ffeature_stories%2Fbiorepositories.html&_state=maximized&_pageLabel=cntvwr (accessed March 6, 2009).
11 Ibid.
12 Doris Jackson, in Her Own Right and as Administratrix of the Estate of Thomas Seaborn, Deceased v. City of Philadelphia and Hospital of the University of Pennsylvania, 26 Phila. Co. Rptr. 545, 551–52 (Pa. Com. Pl. 1993).
13 Michele Goodwin, Black Markets: The Supply and Demand of Body Parts (New York: Cambridge University Press, 2006), 120.
14 Ibid., 177.
15 Thomas Hargrove and Lee Bowman, “Autopsy Rates Differ by Race, Age, Sex, Education,” Scripps Howard News Service, August 12, 2009, www.scrippsnews.com/content/autopsy-rates-differ-race-age-sex-education.
16 “Cornea Donation & Transplantation Statistics,” Eye Bank Association of America, Washington, D.C., http://www.restoresight.org/donation/statistics.
17 Brotherton v. Cleveland Nos. 94-3465; 96-3034, 96-3085, United States Court of Appeals for the Sixth Circuit 173 F.3d 552; 1999; 923 F.2d 482 (6th Cir. 1990).
18 Ibid.
19 Florida v. Powell, Fla., 497 So.2d 1188 (1986).
20 Leigh Hopper, “Heat Wave Heralds a Deadly Season,” Houston Chronicle, June 1, 2003.
21 Personal verbal communication with Joyce Carter, MD, 2000 and 2004.
22 Michele Goodwin, “Feds Should Monitor Body Parts Sales,” Los Angeles Times, March 13, 2004.
23 Amanda Euringer, “Foreskin Face Cream,” The Tyee, January 30, 2007, http://thetyee.ca/Views/2007/01/30/Foreskin/.
24 John Schwartz and Steve Vogel, “Amid German Uproar, U.S. Auto Researchers Defend Use of Corpses,” Washington Post, November 25, 1993.
25 Jonathan Leake and Charles Masters, “Renault Used Child Corpses to Improve Car Safety Seats,” Sunday Times (London), April 19, 1998.
26 This set of trauma-research protocols is under way at eleven U.S. and Canadian sites and will not conclude until 2012.
27 C. O. Callender and P. V. Miles, “Minority Organ Donation: The Power of an Educated Community,” Journal of the American College of Surgeons 210, no. 5 (2010): 708–15, 715–17.
28 Thomas Hargrove and Lee Bowman Scripps, “Autopsy Rates Differ by Race, Age, Sex, Education,” Howard News Service, August 12, 2009, http://www.scrippsnews.com/category/author/-thomas-hargrove-and-lee-bowman-scripps-howard-news-service (accessed July 11, 2011). “When looking at all 4.9 million deaths, whites were autopsied less than 6 percent of the time compared to 11 percent for blacks, 14 percent for Hispanics, 8 percent for Asians and 13 percent for American Indians.”
29 Janice Frink Brown, “D.C. Gift Act Allows Hospitals to Remove Organs of Crime Victims,” Washington Afro-American, June 17, 1995.
30 Harriet A. Washington, “Vital Signs: Harvesting Organs from Silence,” Emerge Magazine, January 31, 1995.
31 www.drcatalona.com/litigation.asp (accessed September 20, 2009).
32 The OHRP later determined that this language was indeed exculpatory in violation of 45 C.F.R. § 46.116.
33 William Catalona, MD, “Dr. Catalona’s Response to Public Statements Posted by Washington University Regarding His Dispute with WU over Who Has Jurisdiction of Prostate Tissue and Blood Samples,” www.drcatalona.com/qanda.html.
34 Order in Washington University v. Catalona, No. 4:03CV1065 (E. Dist. Mo. April 14, 2006), on appeal Nos. 06-2286 & 06-2301 (8th Cir.); Washington University v. Catalona, 437 F. Supp. 2d 985 (E.D. Mo. 2006), affirmed by 490 F.3d 667 (8th Cir. 2007).
35 See also: Eric G. Campbell, PhD, Brian R. Clarridge, PhD, Manjusha Gokhale, MA, et al., “Data Withholding in Academic Genetics: Evidence from a National Survey,” Journal of the American Medical Association 287, no. 4 (2002): 473–80.
36 Arthur Caplan, “The Sale of Tissue Samples from NIH to Pfizer,” blog.bioethics.net, American Journal of Bioethics, June 1, 2006, http://blog.bioethics.net/2006/06/sale-of-tissue-samples-from-nih-to.html.
37 David Wildman, “Case Study: Dr. P. Trey Sunderland III; $508,050 from Pfizer, but No ‘Outside Positions to Note,’ ” Los Angeles Times, December 22, 2004.
38 Richard A. Epstein, “Mad Scientists: Go Away, Ethics Police. Leave the NIH Alone,” Slate, Tuesday, February 15, 2005, http://www.slate.com/id/2113520/ (accessed May 21, 2008).
39 Baruch S. Blumberg, Irving Millman, W. Thomas London, et al., “Ted Slavin’s Blood and the Development of HBV Vaccine,” letter to the editor, New England Journal of Medicine 312, no. 3 (1985): 189.
40 Richard M. Titmuss, The Gift Relationship: From Human Blood to Social Policy (New York: Pantheon Books, 1971).
41 Ibid.
1 Emily Marden, “The Neem Tree Patent: International Conflict over the Commodification of Life,” Boston College International and Comparative Law Review 22, nos. 2–3 (1999): 279.
2 Scott Holwick, “Note, Developing Nations and the Agreement on Trade-Related Aspects of Intellectual Property Rights,” Y.B. Colo. Journal of International Environmental Law and Policy 49 (2000): 57–58.
3 Naomi Roht-Ariaza, “Of Seeds and Shamans: The Appropriation of the Scientific and Technical Knowledge of Indigenous and Local Communities,” Michigan Journal of International Law 919, no. 938 (1996): 926–27.
4 Institute of Biodiversity Conservation, “Conservation, Sustainable Use, Access and Benefit Sharing,” http://www.ibc-et.org/ (accessed May 22, 2008).
5 Diarmuid Jeffreys, Aspirin: The Remarkable Story of a Wonder Drug (New York: Bloomsbury Publishing, 2005). See also: Camilla Dickson and James Dickson, Plants and People in Ancient Scotland (Mount Pleasant, SC: Arcadia Publishing/NPI Media Group 2000).
6 Biotechnology for Sustainable Development in Africa, “African Medicinal Plants, a Resource to Develop and Protect—the Plant of the Month: Catharanthus roseus,” http://www.bdafoundation.org/en/content/african-medicinal-plants (accessed January 3, 2010).
7 Carolina Bruun, “Intellectual Property Rights Reach Indigenous Communities in the Amazon,” Mongabay.com, March 21, 2007, http://news.mongabay.com/2007/0321-galvani.html (accessed March 17, 2010).
8 Ibid.
9 Andrew J. Pollack, “Biological Products Raise Genetic Ownership Issues: Governments Are Demanding Share of Profits,” New York Times, November 26, 1999; see also Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
10 William S. Burroughs and Allen Ginsberg, The Yage Letters (San Francisco: City Lights Publishers, 1991).
11 Martin A. Lee, “Vision Quest: Shamanism vs. Capitalism: The Politics of Ayahuasca,” Ayahuasca Spirit Quest, March 1, 2003, www.biopark.org/peru/vision-quest-metzner.html (accessed May 31, 2009).
12 Pablo Amaringo and Luis Eduardo Luna, Ayahuasca Visions: The Religious Iconography of a Peruvian Shaman (New York: North Atlantic Books, 1999).
13 Richard Spruce and A. R. Wallace, Notes of a Botanist on the Amazon and Andes (New York: Johnson Reprint Corp., 1970).
14 By some accounts, the year was 1981.
15 According to the TRIPS Agreement, developing countries were supposed to implement the agreement by 2000, while the least-developed countries are not required to implement the intellectual-property provisions relating to pharmaceuticals before 2015. (This is a result of the Doha Declaration on TRIPS Agreement and Public Health, 2001.)
16 Vandana Shiva, Biopiracy: The Plunder of Nature and Knowledge (Cambridge, MA: South End Press, 1999).
17 James Nurton, “TRIPs Council to Review Doha Declaration,” Managing Intellectual Property, June 16, 2010, http://www.managingip.com/Article/2601610/TRIPs-Council-to-review-Doha-Declaration.html (accessed June 29, 2010); World Health Organization, The Doha Declaration on TRIPS Agreement and Public Health, http://www.who.int/medicines/areas/policy/doha_declaration/en/
index.html (accessed June 29, 2010).
18 TRIPS also permits the patenting of animals, but it does not force the recognition of these patents in the same manner: “Agreement on Trade-Related Aspects of Intellectual Property Rights,” April 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, Legal Instruments—Results of the Uruguay Round, vol. 31, 33 I.L.M. 81 (1994).
19 Doctors Without Borders/Médecins Sans Frontières, “Sell-Out at WTO on DOHA Declaration?” press release, Geneva, February 12, 2003, http://www.doctorswithoutborders.org/press/release.cfm?id=382&cat=press-release (accessed May 21, 2009).
20 According to Ciel’s website (www.ciel.org), these included the Coordination Body of Indigenous Organizations of the Amazon Basin and the Coalition for Amazonian Peoples and the Environment.
21 Alan L. Durham, Patent Law Essentials: A Concise Guide (Westport, CT: Quorum Books, 1999).
22 “Conditions for patentability; novelty and loss of right to patent,” U.S. Code 35, Sec. 102.
23 Ibid.
24 Lee, “Shamanism vs. Capitalism.”
25 BBC News, “India Wins Landmark Patent Battle,” March 9, 2005, http://news.bbc.co.uk/1/low/sci/tech/4333627.stm (accessed October 7, 2010).
26 R. L. Mahunnah and K. E. Mshigeni, “Tanzania’s Policy on Biodiversity Prospecting and Drug Discovery Programs,” Journal of Ethnopharmacology 51, nos. 1–3 (April 1996): 221–28.
27 Muhimbili University of Health and Allied Sciences, “MUHAS Cooperative Research Agreement IPR Form II/06,” Dar es Salaam, Tanzania, 2006, http://bit.ly/eZsGxb (accessed January 17, 2011).
28 www.monsanto.com/features/helping_haitian_farmers.asp?wt.svl=2 (accessed May 2, 2010).
29 Jonathan M. Katz, “Monsanto Gives Haiti $4 Million in Hybrid Seeds,” Bloomberg Business Week, May 14, 2010, http://www.businessweek.com/ap/financialnews/D9FMUQN80.htm (accessed June 1, 2010).
30 Monsanto Africa Corporate Website, http://www.monsantoafrica.com/.
31 Sara Novak, “Haitian Farmers Refuse Monsanto’s Seeds and Instead Commit to Burning Them,” TreeHugger, May 30, 2010, www.treehugger.com/files/2010/05/
haitian_farmers_refuse_monsantos_seeds_and_instead_commit_to_
burning_them.php (accessed May 30, 2010).
32 Thiram is an ethylene bisdithiocarbamate.
33 Pesticide Management Information Project, Cooperative Extension Office, Cornell University. “Thiram,” EXTOXNET, http://pmep.cce.cornell.edu/profiles/extoxnet/pyrethrins-ziram/thiram-ext.html (accessed April 16, 2010).
34 Elizabeth Vancil, Monsanto’s Development Partnership director, email communication to Emmanuel Prophete, director of seeds at the Haitian Ministry of Agriculture, and others, released by the Haitian Ministry of Agriculture, date unavailable.
35 Ibid.
36 Center for Food Safety, Monsanto vs. US Farmers (Washington, D.C.: Center for Food Safety, 2005), http://www.centerforfoodsafety.org/pubs/
lowresCFSMonsantovsFarmersReport1.13.2005.pdf; Center for Food Safety, “Monsanto vs. US Farmers, November 2007 Update” (Washington, D.C.: Center for Food Safety, 2007), http://www.centerforfoodsafety.org/pubs/Monsanto%20November%202007%20update.pdf.
37 Ibid.
38 The Monsanto Co., “Seed Piracy: Updates and Summaries,” company newsletter, September/October 2009, http://www.cban.ca/Resources/Topics/Monsanto/Monsanto-s-Seed-Piracy-Newsletter (accessed June 9, 2010).
39 The Canadian Biotechnology Action Network, Monsanto, http://www.cban.ca/Resources/Topics/Monsanto.
40 La Vía Campesina/International Peasant Movement, “La Vía Campesina Carries Out Global Day Of Action Against Monsanto,” press release, October, 16, 2009, http://viacampesina.org/en/index.php?option=com_content&view=article&id=797:peasants-worldwide-rise-up-against-monsanto-gmos&catid=49:stop-transnational-corporations&itemid=76 (accessed June 13, 2010).
41 Nathan B. Batalion, “Introduction,” 50 Harmful Effects of Genetically Modified Foods (Oneonta, NY: Americans for Safe Food, 2000), http://www.raw-wisdom.com/50harmful.
42 William Neuman and Andrew Pollack, “U.S. Farmers Cope with Roundup-Resistant Weeds,” New York Times, May 3, 2010, http://www.nytimes.com/2010/05/04/business/energy-environment/04weed.html?_r=1; Neuman and Pollack, “Where Weedkiller Won’t Work,” New York Times, May 3, 2010, http://www.nytimes.com/interactive/2010/05/03/business/weeds-graphic.html?ref=energy-environment.
43 Michael Pollan, “We Knew It Was Coming,” New York Times, June 1, 2010, http://roomfordebate.blogs.nytimes.com/2010/05/06/invasion-of-the-superweeds/?ref=energy-environment (accessed June 1, 2010).
44 Masaharu Kawata, GMO Information Service, “Monsanto Failed Halfway in Developing Herbicide Tolerant Rice in Japan,” December 5, 2002, http://www.mindfully.org/GE/GE4/Monsanto-Rice-Failed-Japan5dec02.htm (accessed June 24, 2010).
45 Lucia Graves, “Roundup: Birth Defects Caused by World’s Top-Selling Weedkiller, Scientists Say,” Huffington Post, June 24, 2011, http://www.huffingtonpost.com/2011/06/24/roundup-scientists-birth-defects_n_883578.html (accessed June 28, 2011).
46 According to a study by the Sakal Newspapers Limited of the two districts, Amravati and Yavatmal.
47 Amy Waldman, “Debts and Drought Drive India’s Farmers to Despair,” New York Times, June 6, 2004, http://www.nytimes.com/2004/06/06/world/debts-and-drought-drive-india-s-farmers-to-despair.html (accessed February 3, 2011).
48 Raj Patel, Stuffed and Starved: The Hidden Battle for the World Food System (London: Portobello Books, 2007).
49 Tamil Nadu, “Spate of Farmers’ Suicides in India Worrying WHO,” The Hindu, October 15, 2006, http://www.hindu.com/2006/10/15/stories/2006101514820800.htm.
50 P. Sainath, “17,368 Farm Suicides in 2009,” The Hindu, December 27, 2010, http://www.thehindu.com/opinion/columns/sainath/article995824.ece?homepage=true (accessed January 4, 2011).
51 Ibid.
52 Sonia Faleiro, “A Death of a Son, Grandson, and All of Life’s Dreams,” September 2, 2006, http://soniafaleiro.blogspot.com/2006/09/death-of-son-grandson-and-all-of-lifes.html (accessed May 13, 2010).
53 K. Samu, Human Rights Documentation, Indian Social Institute, “Agriculture & Farmers’ Suicide—2006.” Report, New Delhi, 2006, p. 43. http://www.isidelhi.org.in/hrnews/HR_THEMATIC_ISSUES/
Agriculture/Agriculture-2006.pdf.
54 Indian agriculture department statistics.
55 PBS, “Seeds of Suicide: India’s Desperate Farmers,” Frontline, July 26, 2005, http://www.pbs.org/frontlineworld/rough/2005/07/seeds_of_suicid.html#.
56 The Editors, “Do Seed Companies Control GM Crop Research?” Scientific American, August 13, 2009, http://www.scientificamerican.com/article.cfm?id=do-seed-companies-control-gm-crop-research (accessed June 17, 2010).
57 Toni McNulty, “A New Earthquake Hits Haiti—Monsanto,” Wired: Haiti Rewired, May 12, 2010, http://haitirewired.wired.com/profiles/blogs/a-new-earthquake-hits-haiti (accessed May 12, 2010).
58 “Linda J. Fisher: Director, Covanta Holding Corporation,” Forbes.com, http://people.forbes.com/profile/linda-j-fisher/23695 (accessed February 16, 2009).
59 Kim Griggs, “ ‘Human’ Cow Milk an MS Aid?” Wired, August 2, 2000, http://www.wired.com/science/discoveries/news/2000/08/37921 (accessed February 15, 2011).
60 “Paul Reynolds provides a detailed account of the opposition by the Ngati Wairere sub-tribe (hapu) in the central North Island of Aotearoa to AgResearch, a government research agency, which attempted to place copies of human genes into cows to produce a human-cow hybrid. The opposition was based on the concern about lack of consultation with local communities and the impact this type of research will have on whakapapa (genealogy). The case provided a platform for future consciousness raising on biotechnology amongst Maori”: from Pacific Genes and Life Patents, Pacific Experiences & Analysis of the Commodification & Ownership of Life, eds. Aroha Mead and Dr. Steven Ratuva (Japan: Call of the Earth/Llamado de la Tierra, the United Nations University Institute of Advanced Studies, 2007).
61 Alok Jha, “First British Human-Animal Hybrid Embryos Created by Scientists,” Guardian, April 2, 2008, http://www.guardian.co.uk/science/2008/apr/02/
medicalresearch.ethicsofscience.
62 “Phyllomedusa Bicolour,” http://species.wikimedia.org/wiki/Phyllomedusa_bicolor (accessed April 25, 2010).
63 Donald W. Hansen Jr. et al., “Systemic Analgesic Activity and ∂-Opiod Selectivity in [2,6-Dimetyl-Ty1r,D-Pen2,D-Pen5]enkephalin,” Journal of Medicinal Chemistry 35, no. 4 (1992): 684–87.
64 The Tristan da Cunha Website, http://www.tristandc.com/ (accessed April 24, 2009).
65 Noé Zamel, “In Search of the Genes of Asthma on the Island of Tristan da Cunha,” Canadian Respiratory Journal 2, no. 1(1995): 18–22.
66 “Tristan da Cunha,” Wikipedia, http://en.wikipedia.org/wiki/Tristan_da _Cunha (accessed April 24, 2009).
67 Sequana Therapeutics, Inc., “Sequana Discovers Asthma Gene,” press release, BusinessWire, May 21, 1997, http://www.allbusiness.com/medicine-health/diseases-disorders-respiratory/6985305–1.html (accessed April 24, 2010).
68 Axys Pharmaceuticals, “Arris and Sequana Merge to Form New Company, Axys Pharmaceuticals; Deal Valued at $166 Million,” November 3, 1997, http://www.secinfo.com/dr6nd.84Ea.c.htm.
69 Randall Mayes, “In Defense of Patenting DNA: A Pragmatic Libertarian Perspective,” Ethical Technology/ The Institute for Ethics & Emerging Technologies, July 26, 2009, http://ieet.org/index.php/IEET/more/mayes20090726/ (accessed May 29, 2008).
70 Sequana press release dated October 28, 1997.
71 GENSET Corp., “Research Milestone in Prostate Cancer Alliance,” press release, PR Newswire, December 17, 1996, http://www.prnewswire.co.uk/cgi/news/release?id=58604 (accessed February 17, 2011).
72 GENSET Corp., “GenSet and the Chinese Academy of Medical Sciences to enter joint venture for Genomics Research,” press release, November 4, 1996.
73 Mayes, “In Defense of Patenting DNA.”
74 Havasupai, www.havasupaitribe.com (accessed May 3, 2007).
75 Heather M. Butts, JD, MPH, and Ruth L. Fischbach, PhD, MPE, “What Should IRBs Consider When Reviewing a Protocol in Which Race Will Be Identified?” (Lecture, EGIR Conference, May 19, 2006, presentation slides 24–27).
76 The 1778 advent of Captain Cook is generally acknowledged as the beginning of Hawaiian–Western interactions.
77 Cheryl Ernst, “Making the Most of the Hawaiian Genome,” Health: University of Hawai’i System Newsletter, March 3, 2003, http://www.hawaii.edu/ur/newsatuh/archives/030303/health.htm (accessed February 17, 2011).
78 Pei Koay, “Icelandic (Ad)ventures: New Research? New Subjects? New Ethics?” in Twentieth-Century Ethics of Human Subjects Research: Historical Perspectives on Values, Practices, and Regulations, eds. Volker Roelke and Giovanni Maio (Stuttgart, Germany: Franz Steiner Verlag, 2004).
79 It is widely believed that presumed consent is used to harvest organs in many European countries as well, but this is a misconception. Most of these countries never claim to presume that their citizens would consent to obtain organs, an important distinction in that there is no assumption of the dead person or his family’s having ownership in the body, and no mechanism for opting out: Robert Veatch and Jonathan Pitt, “The Myth of Presumed Consent: Ethical Problems in New Organ Procurement Strategies,” Transplantation Ethics, ed. Robert M. Veatch (Washington, D.C.: Georgetown University Press, 2001), 167.
80 Michael Specter, “Decoding Iceland,” The New Yorker, January 18, 1999, 40–51.
81 Kevin Davies, Cracking the Genome: Inside the Race to Unlock Human DNA (New York: The Free Press), 134.
82 Jocelyn Kaiser, “deCODE Genetics Rises from the Ashes,” ScienceInsider, January 21, 2010, http://news.sciencemag.org/scienceinsider/2010/01/decode-genetics-1.html.
1 The case Abdullahi et al v. Pfizer is available at http://www.pdf-searcher.com/Abdullahi-et-al-v.-Pfizer-Decision.html# (accessed November 22, 2010).
2 Joe Stephens, “The Body Hunters: As Drug Testing Spreads, Profits and Lives Hang in Balance,” Washington Post, December 17, 2000, http://www.washingtonpost.com/wp-dyn/world/issues/bodyhunters/.
3 IPS-Inter Press Service/Global Information Network, “Nigeria: Lawsuit Revived Against U.S. Company over Testing,” October 14, 2003; Muyiwa Adeyemi, “Niger Suspends Boycott,” Guardian, February 28, 2004; see also George J. Annas, “Faith (Healing), Hope and Charity at the FDA: The Politics of AIDS Drug Trials,” Villanova Law Review 34 (1989): 771, 772.
4 Joe Stephens, “The Body Hunters: As Drug Testing Spreads, Profits and Lives Hang in Balance,” Washington Post, December 17, 2000, http://washingtonpost.com/wp-dyn/articles/A11939-2000Dec15.html.
5 Duff Wilson, “A Secret Cable Discusses Pfizer’s Actions in Nigeria Case,” New York Times, December 10, 2010, http://www.nytimes.com/2010/12/11/business/npfizer.html (accessed March 22, 2011).
6 Yvonne Ndege, “Nigerian Pfizer Victims’ Compensation Fears—26-06-2011,” Al Jazeera, http://tvjin.net/2011/06/27/nigerian-pfizer-victims-compensation-fears-26-06-2011/ (accessed June 24, 2011).
7 “Trovan: Pfizer Commences Screening of Victims,” April 9, 2011, Channels, http://www.channelstv.com/global/news_details.php?nid=26633&cat =Health (accessed June 9, 2011).
8 Ndege, “Nigerian Pfizer Victims’ Compensation Fears.”
9 Office of U.S. Global AIDS Coordinator, Bureau of Public Affairs, U.S. Department of State, The United States President’s Plan for Emergency AIDS Relief, http://www.pepfar.gov/about/index.htm.
10 Ibid.
11 Pari Shah and Ann Juergens-Behr, “Vaccine Programs in Developing Countries” (Course Presentation, Bio 160, Brown University), http://www.brown.edu/Courses/Bio_160/Projects2000/
VaccineIssues/Vaccines.html.
12 Michael Kremer, “Pharmaceuticals and the Developing World,” Journal of Economic Perspectives 16, no. 4 (Fall 2002): 68, 71, 79, 90.
13 Brook K. Baker, “The Eight Deadly Lies of Big Pharma,” The Nation (Thailand), April 21, 2007, http://www.nationmultimedia.com/2007/04/21/ opinion/opinion_30.
14 Kremer, “Pharmaceuticals and the Developing World.”
15 GlaxoSmithKline plc., “Our Commitment to Fighting Malaria,” http://www.gsk.com/media/malaria.htm (accessed April 25, 2010).
16 Amir Attaran, DPhil, LLB, and Lee Gillespie-White, LLB, “Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatments in Africa?” Journal of the American Medical Association 286, no. 15 (2001): 1886–92.
17 Donald G. McNeil Jr., “Patents or Poverty? New Debate over Lack of AIDS Care in Africa,” New York Times, November 5, 2001.
18 Amir Attaran, “Do Patents Prevent Access to Drugs for HIV in Developing Countries?” Journal of the American Medical Association 287, no. 7 (February 20, 2002).
19 Amir Attaran, DPhil, LLB, “How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries?” Journal of Health Affairs 23, no. 3 (2004): 155–56, http://content.healthaffairs.org/content/23/3/155.full.pdf (accessed February 21, 2009).
20 James Shikwati, “Poverty, Not Patents, Is to Blame,” Business Day (Johannesburg), June 7, 2004, http://allafrica.com/stories/200406010952.html.
21 Amir Attaran, DPhil, LLB, “How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries?” Journal of Health Affairs 23, no. 3 (2004): 155–56, http://content.healthaffairs.org/content/23/3/155.full.pdf (accessed February 21, 2009).
22 Franklin Cudjoe, “Poverty and Sickness Won’t Be Cured by Fighting Patents,” New Times, Rwanda’s First Daily, January 3, 2011, http://www.newtimes.co.rw/index.php?issue=13572&article=7362.
23 McNeil Jr., “Patents or Poverty?”
24 Nurton, “TRIPS Council to Review Doha Declaration”; WHO, “The Doha Declaration on TRIPS Agreement and Public Health.”
25 Kremer, “Pharmaceuticals and the Developing World.”
26 “The Burden of Different Diseases Can Be Compared Across Countries Using the Concept of Disability Adjusted Life Years. DALYs Take into Account Not Only the Lives Lost Through Disease, but Also the Number of Years of Disability Caused”: Ibid.
27 Kremer, “Pharmaceuticals and the Developing World.”
28 Ibid., 70.
29 World Health Organization, High Level Forum on the Health MDGs. Addressing Africa’s Health Workforce Crisis: An Avenue for Action, 2004, www.hlfhealthmdgs.org/Documents/AfricasWorkforce-Final.pdf; see also Nullis-Kapp, “Health Worker Shortage Could Derail Development Goals (News).”
30 Central Bureau of Health Intelligence, Directorate General of Health Services, Ministry of Health and Family Welfare, Health Information of India 2000 and 2001 (New Delhi: Government of India, 2003), http://cbhidghs.nic.in/Hii2000–01/content.htm.
31 World Health Organization, The World Health Report 2003 (Geneva: World Health Organization, 2003).
32 Harriet A. Washington, “Why Africa Fears Western Medicine,” New York Times, July 31, 2007, http://www.nytimes.com/2007/07/31/opinion/31washington.html.
33 John Murphy, “Distrust of U.S. Foils Effort to Stop Crippling Disease,” Baltimore Sun, January 4, 2004, http://www.baltimoresun.com/news/bal-polio0104,1,1640318.story.
34 Washington, “Why Africa Fears Western Medicine.”
35 Seth W. Glickman, MD, MBA, et al., “Ethical and Scientific Implications of the Globalization of Clinical Research,” New England Journal of Medicine 360, no. 8 (February 2009): 816.
36 Ibid.
37 Kenneth A. Getz, “Global Clinical Trials Activity in the Details,” Applied Clinical Trials, September 1, 2007, http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/
article/articleDetail.jsp?id=453243 (accessed January 30, 2009).
38 Washington Office on Haiti and the National Vaccine Information Center, “More Than 2000 Children in the Port-au-Prince Slum Cite Soleil Were Inoculated with High Doses of Edmonston-Zagreb (EZ),” April 1999.
39 J. P. Garnier, “Rebuilding the R&D Engine in Big Pharma,” Harvard Business Review 68 (2008): 68–76.
40 World Health Organization, “Making the Most of Existing Health Workers,” Working Together for Health: The World Health Report 2006 (Geneva: World Health Organization, 2006), 66–95, http://www.who.int/whr/2006/chapter4/en/index.html (accessed January 30, 2009).
41 Office of Inspector General, Department of Health and Human Services, The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (Washington, D.C.: Department of Health and Human Services, 2001) (DHHS publication no. OEI-01–00–00190), http://oig.hhs.gov/oei/reports/oei-01-00-00190.pdf.
42 Jim Edwards, “Pfizer Case over Test That Killed 11 Kids Could Blow the Lid Off Foreign Drug Trials,” The CBS Interactive Business Network, June 30, 2010 http://industry.bnet.com/pharma/10008781/pfizer-that_killed_11_kids_could_blow_the_lid_off_foreign_drug_trials_case-over-test.com.
43 Amanda Silverio, “HIV Research in Africa: A Series of Paradoxes,” Stanford Journal of International Relations, http://www.stanford.edu/group/sjir/3.2.05_silverio.html.
44 Harold Varmus, MD, and David Satcher, MD, PhD, “Ethical Complexities of Conducting Research in Developing Countries,” New England Journal of Medicine 337, no. 14 (October 1997): 1003–05.
45 Tim Beardsley, “Coping with HIV’s Ethical Dilemmas,” Scientific American 279, no. 1 (July 1998): 86, http://www.genethik.de/aids/aids09.htm.
46 Marcia Angell, “The Ethics of Clinical Research in the Third World,” New England Journal of Medicine 337, no. 12 (September 1997): 847–49.
47 A. A. Hyder, S. A. Wali, A. N. Khan, et al., “Ethical Review of Research: A Perspective from Developing Country Researchers,” Journal of Medical Ethics 30, no. 1 (2004): 68–72.
48 D. Zhang, et al., “An Assessment of the Quality of Randomized Controlled Trials Conducted in China,” Trials 9 (2008): 22.
49 Francis Moore, “Letter to Jay Katz, September 2, 1964,” reprinted in Experimentation with Human Beings: The Authority of the Investigator, Subject Professions, and State in the Human Experimentation Process, ed. Jay Katz, MD (New York: Russell Sage Foundation, 1972), 663.
50 Jon Cohen, “Brazil, Thailand Override Big Pharma Patents,” Science 316, no. 5826 (2007): 816.
51 United States Chamber of Commerce, “Brazil Takes Major Step Backward on Intellectual Property Rights, Says US Chamber,” press release, May 4, 2007, http://www.uschamber.com/press/releases/2007/may/brazil-takes-major-step-backward-intellectual-property-rights-says-us-chamber.
52 Cohen, “Brazil, Thailand Override Big Pharma Patents.”
53 Ibid.
54 Editorial, “India’s Choice,” International Herald Tribune, January 18, 2005, http://www.nytimes.com/2005/01/18/opinion/18tues2.html.
55 “Pharmaceutical Patents and Developing Countries,” AIDS.org, http://www.aids.org/atn/a-330-08.html (accessed July 13, 2009).
56 A set-top box or set-top unit connects a television with the external source of its signal.
57 James Love, “Brazil Puts Patients Before Patents,” Huffington Post, May 4, 2007, http://www.huffingtonpost.com/james-love/brazil-puts-patients-befo_b_47651.html (accessed June 13, 2009).
58 Patents and Technological Progress in a Globalized World: Liber Amicorum Joseph Straus, eds. Wolrad Prinz zu Waldeck und Pyrmont, Martin J. Adelman, Robert Brauneis, and Josef Drexl (Berlin and Heidelberg: Springer, 2009), 153.
59 Sarah Joseph, “Pharmaceutical Corporations, Access to Drugs, and Human Rights,” http://www.law.monash.edu.au/castancentre/conference2001/
papers/joseph.html, note 87 (accessed November 25, 2009).
1 Sara Boettiger and Alan B. Bennet, “Bayh-Dole: If We Knew Then What We Know Now,” Nature Biotechnology 24 (2006): 320–23.
2 “NF-κB stands for nuclear factor kappa-light-chain-enhancer of activated B cells, a proteinaceous complex found in nearly all animal cells that governs the regulation of DNA transcription”: A. R. Brasier, “The NF-κB Regulatory Network,” Cardiovascular Toxicology 6, no. 2 (2006): 111–30.
3 “Bayhing for Blood or Doling Out Cash?” The Economist, December 20, 2005, http://www.economist.com/node/5327661 (accessed March 10, 2010).
4 Chris Frates, “Love Is Never Having to Say You Lobby,” Politico, March 18, 2009, http://www.politico.com/news/stories/0309/20153.html (accessed January 13, 2011).
5 Madey v. Duke University, 307 F.3d 1351.
6 “Bayhing for Blood or Doling Out Cash?” The Economist.
7 Gina Kolata, “Sharing of Data Leads to Progress on Alzheimer’s,” New York Times, August 12, 2010, http://www.nytimes.com/2010/08/13/health/research/13alzheimer.html (accessed August 12, 2010).
8 The Stanford Bernstein Report concludes that the industry’s best hope for survival lies in innovation, its traditional strength. But, it is important to note that R&D is not as productive as it used to be. The global industry saw 24 new drugs approved by the US Food and Drug Administration in 1998 with $27 billion R&D investment. In 2006, only 13 new drugs were approved, but investments in R&D rose to $64 billion. As a result the business model of a vertically integrated approach to developing, manufacturing and selling drugs has changed in favor of outsourcing. This new model favors developing countries that are able to attract investments, i.e., those with strong IP systems.
9 The African meningitis belt includes all or parts of Gambia, Senegal, Mali, Burkina Faso, Ghana, Niger, Nigeria, Cameroon, Chad, the Central African Republic, Sudan, Uganda, Kenya, Ethiopia, and Eritrea, according to http://www.lycos.com/info/meningitis–meningitis-belt.html (accessed November 2, 2010).
10 GAVI Alliance, Advanced Market Commitments for Vaccines, http://www.vaccineamc.org/index.html (accessed August 7, 2010).
11 “Our Mission: Eliminating Epidemic Meningitis in Sub-Saharan Africa,” PATH, Meningitis Vaccine Project, http://www.meningvax.org/mission.php.
12 Kat Hannaford, “Bill Gates Convinces 40 Billionaires to Give Away Half Their Fortunes,” Gizmodo, August 4, 2010, http://gizmodo.com/#l5604368/bill-gates-convinces-40-billionaires-to-give-away-half-their-fortunes.
13 The Giving Pledge, http://givingpledge.org/#enter (accessed December 1, 2010).
14 “Supporters,” Advance Market Commitment for Vaccines, http://www.vaccineamc.org/progress_supporters.html.
15 Kate Kelland, “Drug Makers Cut Vaccine Prices for Poorer Nations,” Reuters News Service, Monday, June 6, 2011, http://www.reuters.com/article/2011/06/06/us-vaccines-prices-gavi-idUSTRE7550UH20110606 (accessed June 6, 2011).
16 Gamal Fahnbulleh, “Billions Pledged to Vaccinate World’s Poor,” Sky News, June 13, 2011, http://uk.news.yahoo.com/pm-makes-promise-vaccinate-worlds-poor-001508370.html (accessed June 14, 2011).
17 Stephanie Nebehay, “Pharma Industry Pledges Pandemic Vaccines and Know-How in Landmark Deal,” March 18, 2011, Reuters Health, http://www.reuters.com/article/2011/04/16/us-pandemic-vaccines-idUSTRE73F0HO20110416 (accessed June 17, 2011).
18 Kelland, “Drug Makers Cut Vaccine Prices.”
19 Henry Grabowski, “Encouraging the Development of New Vaccines,” Health Affairs 24, 3 (2005): 697–700, http://content.healthaffairs.org/content/24/3/697.full (accessed June 16, 2011).
20 Fahnbulleh, “Billions Pledged to Vaccinate.”
21 Ibid.
22 Carroll, “Big Pharma Maps Out a Global Vaccine Strategy.”
23 “Cheap Vaccines Make Business Sense,” Micah Challenge antipoverty blog, http://www.micahchallenge.org/component/content/article/81-amanda-advocates/404-cheap-vaccines-make-business-sense (accessed June 25, 2011).
24 Ibid.
25 World Health Organization, “Fact Sheet No. 259: African Trypanosomiasis (Sleeping Sickness),” October 2010, http://www.who.int/mediacentre/factsheets/fs259/en/index.html (accessed July 3, 2011).
26 Aidan Hollis and Thomas Pogge, The Health Impact Fund: Making Medicines Available for All (New Haven, CT: Incentives for Global Health, 2008), chapter 2.
27 Ibid., 3–4.
28 Ibid. See also Peter Singer, “Tuberculosis or Hair Loss? Refocusing Medical Research,” National Post, September 15, 2008, http://www.project-syndicate.org/commentary/singer40/English (accessed May 24, 2011).
29 The Structural Genomics Consortium, http://thesgc.org.
30 Ogilvie, “Secrecy Slowing Drug Research.”