Overdosed America (49 page)

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AIDS activists drew attention:
David Willman, “How a New Policy Led to Seven Deadly Drugs,”
Los Angeles Times,
December 20, 2000.

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2002 GAO report:
United States General Accounting Office, “Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities,” September 2002.

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increase the staff at the Center for Drug Evaluation and Research, or CDER, from 1300 to 2300:
U.S. General Accounting Office, “Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities,” September 2002, p. 8, 10.

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Public Citizen in 1998:
Peter Lurie and Sidney M. Wolfe, “FDA Medical Officers Report Lower Standards Permit Dangerous Drug Approvals,” Public Citizen Health Research Group. Viewed at http://www.citizen.org/publications/release.cfm?ID= 7104. Accessed September 22, 2002.

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the inspector general of the U.S. Department of Health and Human Services:
Department of Health and Human Services, Office of Inspector General, “FDA’s Review Process for New Drug Applications,” March 2003.

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creating “a sweatshop environment:
Larry Thompson, “User Fees for Faster Drug Reviews: Are They Helping or Hurting Public Health,”
FDA Consumer Magazine,
September–October 2000. Viewed at http://www.fda.gov/fdac/features/2000/500_pdufa.html. Accessed April 1, 2003.

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drugs approved by the FDA but later withdrawn:
U.S. General Accounting Office, op. cit., pp. 3–4.

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causing more than 1000 deaths:
Willman, op. cit.

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Rezulin is one of the drugs:
David Willman, “Diabetes Drug Rezulin Pulled Off the Market,”
Los Angeles Times,
March 22, 2000.

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Pulitzer Prize–winning series of investigative reports:
The series of articles make a great read if you want to get the inside scoop on a deadly failure of the FDA and NIH, available on the Pulitzer Prize website: Viewed at http://www.pulitzer.org/year/2001/investigative-reporting/. Accessed September 25, 2003.

87
Dr. Richard Eastman was the director of the NIH division:
David Willman, “FDA’s Approval and Delay in Withdrawing Rezulin Probed,”
Los Angeles Times,
August 16, 2000. Viewed at http://www.pulitzer.org/year/2001/investigative-reporting/works/willman6.html. Accessed September 25, 2003.

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Dr. Eastman announced that Rezulin:
David Willman, “Waxman Queries NIH on Researcher’s Ties,”
Los Angeles Times,
December 9, 1998. Viewed at http://www.house.gov/waxman/news_files/news_letters_rezulin_press_NIH_sci_ties_12_9_98.htm. Accessed September 27, 2003.

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Warner-Lambert submitted Rezulin to the FDA:
David Willman, “‘Fast Track’ Drug to Treat Diabetes Tied to 33 Deaths,”
Los Angeles Times,
December 6, 1998. Viewed at http://www.house.gov/waxman/news_files/news_letters_rezulin_press_FDA_fast_track_12_6_98.htm. Accessed February 26, 2004.

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“complained about Gueriguian:
Philip J. Hilts,
Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation,
New York: Knopf, 2003, p. 133.

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reports of fatal liver toxicity due to Rezulin:
David Willman, “FDA’s Approval . . . ,” op. cit.

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Audrey LaRue Jones:
David Willman, “Fears Grow Over Delay in Removing Rezulin,”
Los Angeles Times,
March 10, 2000.

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$1.8 billion worth of the drug:
David Willman, “Diabetes Drug Rezulin Pulled Off the Market,”
Los Angeles Times,
March 22, 2000. Viewed at http://www.pulitzer.org/year/2001/investigative-reporting/works/willman5b.html. Accessed September 29, 2003.

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Dr. Gueriguian told the
Los Angeles Times:
David Willman, “How a New Policy Led to Seven Deadly Drugs,”
Los Angeles Times,
December 20, 2000. Viewed at http://www.pulitzer.org/year/2001/investigative-reporting/works/willman1.html. Accessed September 28, 2003.

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former supporter of Rezulin:
David Willman, “Physician Who Opposes Rezulin Is Threatened by FDA with Dismissal,”
Los Angeles Times,
March 17, 2000.

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Dr. Janet B. McGill, an endocrinologist:
David Willman, “Fears Grow Over Delay in Removing Rezulin,”
Los Angeles Times,
March 10, 2000. Viewed at http://www.pulitzer.org/year/2001/investigative-reporting/works/willman4.html. Accessed September 25, 2003.

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Dr. Eastman, while in charge of diabetes research:
David Willman, “Researcher’s Fees Point to Other Potential Conflicts at NIH,”
Los Angeles Times,
January 28, 1999. Viewed at http://www.house.gov/waxman/news_files/news_letters_rezulin_press_NIH_conflict_1_28_99.htm. Accessed September 30, 2003.

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no fewer than 12 of the 22:
David Willman, “Scientist Who Judged Pill Safety Received Fees; Grants: Records Show Varied Financial Ties Between Researchers and Maker of Diabetes Drug Linked to Deaths,”
Los Angeles Times,
October 29, 1999.

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multiple examples of NIH officials receiving payments:
David Willman, “Stealth Merger: Drug Companies and Government Medical Research,”
Los Angeles Times,
December 7, 2003.

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54 percent of the experts:
Dennis Cauchon, “FDA Advisers Tied to Industry,”
U.S.A. Today,
September 25, 2000.

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spent $177 million on lobbying in 1999 and 2000:
Leslie Wayne and Melody Petersen, “A Muscular Lobby Rolls Up Its Sleeves,”
New York Times,
November 11, 2001.

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$65 million for so-called issue ads:
“The Other Drug War: Big Pharm’s 625 Washington Lobbyists,” Public Citizen Congress Watch, July 2001.

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tipping progressively more toward the Republicans:
Ibid.

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made public:
Letter from Jim Nicholson, chairman of the Republican National Committee, to Charles A. Heimbold Jr., chairman and CEO of Bristol-Myers Squibb Company, April 9, 1999. Viewed at http://www.publici.org/dtaweb/downloads/story_01_062403_BCRA7.pdf. Accessed September 15, 2003.

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Prior to 1970, medical researchers:
T. E. Andreoli, “The Undermining of Academic Medicine,”
Academe
6:32–37, 1999. Viewed at http://www.aaup.org/publications/Academe/1999/99nd/ND99Andr.htm. Accessed January 15, 2004.

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thumbing “their academic noses:
Quoted from Sheldon Krimsky,
Science in the Private Interest,
Lanham Md.: Rowman & Littlefield, 2003, p. 79.

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medical industry was more than willing:
Derek Bok,
Universities in the Marketplace,
Princeton, N.J.: Princeton University Press, 2003, p. 174.

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by 1990 almost two-thirds of requests:
Andreoli, op. cit.

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drug company expenditures on research and development:
Chapter 2
: Dramatic Growth of Research and Development, Pharmaceutical Research and Manufacturers of America (PhRMA),
Pharmaceutical Industry Profile 2003.
Washington, D.C.: PhRMA, 2003. Viewed at http://www.phrma.org/publications/publications/profile02/2003%20CHAPTER%202.pdf. Accessed February 14, 2003.

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In 1991, four out of five:
T. Bodenheimer, “Uneasy Alliance: Clinical Investigators and the Pharmaceutical Industry,”
New England Journal of Medicine
342:1539–1544, 2000.

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reaching 80 percent:
“Clinical Trial Spending in the U.S. Forecast to Cross $26.5 Billion by 2007,”
Business Communications Company, Inc.,
April 17, 2003. Accessed on May 12, 2004 at http://www.bccresearch.com/editors/RB-171.html.

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By 2000, only one-third:
Melody Petersen, “Madison Ave. Has Growing Role in the Business of Drug Research,”
New York Times,
November 22, 2002.

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“They are seduced by industry:
Quoted in Richard A. Knox, “Science and Secrecy: A New Rift Proprietary Interests Found to Intrude on Research Disclosure,”
Boston Globe,
March 30, 1999.

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September 2001, an unprecedented alarm:
F. Davidoff, C. D. DeAngelis, J. M. Drazen, et al., “Sponsorship, Authorship, and Accountability,”
Journal of the American Medical Association
286:1232–1234, 2001.

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published in JAMA:
J. E. Bekelman, Y. Li, and C. P. Gross, “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review,”
Journal of the American Medical Association
289:454–465, 2003.

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British Medical Journal:
J. Lexchin, L. A. Bero, B. Djulbegovic, and O. Clark, “Pharmaceutical Industry Sponsorship and Research Outcome and Quality: A Systematic Review,”
British Medical Journal
326:1167–1170, 2003.

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the highest-quality clinical trials:
B. Als-Nielsen, W. Chen, C. Cluud, and L. L. Kjaergard, “Association of Funding and Conclusions in Randomized Drug Trials,”
Journal of the American Medical Association
290:921–928, 2003.

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The techniques used:
This article provides many examples of the techniques that can be and are used to influence the outcome of medical research. L. A. Bero and D. Rennie, “Influences on the Quality of Published Drug Studies,”
International Journal of Technology Assessment in Health Care
12:209–237, 1996.

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The risk:
K.-H. Kuck, R. Cappato, J. Siebels, et al., “Randomized Comparison of Antiarrhythmic Drug Therapy with Implantable Defibrillators in Patients Resuscitated from Cardiac Arrest,
Circulation
748–754, 2000.

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cost of the defibrillator:
Melody Petersen, “Heart Device to Get More U.S. Support,”
New York Times,
June 7, 2003.

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turned its attention to the 400,000 Americans:
A. J. Moss, Z. Wojciech, J. Hall, et al., “Prophylactic Implantation of a Defibrillator in Patients with Myocardial Infarction and Reduced Ejection Fraction,”
New England Journal of Medicine
346:877–883, 2002.

100
a group of Italian researchers:
R. Belardinelli, D. Georgiou, G. Cianci, and A. Purcaro, “Randomized, Controlled Trial of Long-Term Moderate Exercise Training in Chronic Heart Failure: Effects on Functional Capacity, Quality of Life, and Clinical Outcome,”
Circulation.
99:1173–1182, 1999.

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not exactly the same as in the defibrillator study:
The patients in the exercise study had more severe heart failure, were younger (55 versus 64 years old), and did not all have heart disease caused by inadequate blood supply through the coronary arteries (85 percent versus 100 percent).

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smoking cessation after heart attack:
Average reduction in the absolute risk of death among the 12 studies reviewed is 11.1 percent, and the relative risk reduction in smokers is 46 percent compared with those who continued to smoke. The patients in these studies all had heart attacks, but ejection fraction or the incidence of congestive heart failure is not reported, precluding direct comparison with the defibrillator study. K. Wilson, N. Gibson, A. Willan, and D. Cook, “Effect of Smoking Cessation on Mortality After Myocardial Infarction: Meta-Analysis of Cohort Studies,”
Archives of Internal Medicine
160:939–944, 2000.

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the acid-blocking drug Prilosec:
Organic molecules of identical chemical composition can occur in two forms that are mirror images of each other. Prilosec is a mix of both forms. Nexium is composed of only one form.

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“head-to-head” studies between Prilosec and Nexium:
J. E. Richter, P. J. Kahrilas, J. Johanson, et al., “Efficacy and Safety of Esomeprazole Compared to Omeprazole in GERD Patients with Erosive Esophagitis: A Randomized Controlled Trial,”
American Journal of Gastroenterology
96:656–665, 2001.

102
Would 40 mg of Prilosec daily:
See http://www.nexium-us.com/science/cva05c.asp. Accessed November 29, 2003.

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sufficient for the FDA:
M. Angell, “The Pharmaceutical Industry—To Whom Is It Accountable?”
New England Journal of Medicine,
342:1902–1904, 2000.

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OxyContin’s ability to provide relief:
A. Cheville, A. Chen, G. Oster, et al., “A Randomized Trial of Controlled-Release Oxycodone During Inpatient Rehabilitation Following Unilateral Total Knee Arthroplasty,”
Journal of Bone and Joint Surgery
83-A(4):572–576-12, 2001.

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editorial in the
Canadian Medical Association Journal
:
P. A. Rochon, P. B. Berger, and M. Gordon, “The Evolution of Clinical Trials: Inclusion and Representation,”
Canadian Medical Association Journal
159:1373–1374, 1998.

104
Studies of cancer drugs:
M. Mitka, “Too Few Older Patients in Cancer Trials: Experts Say Disparity Affects Research Results and Care,”
Journal of the American Medical Association
290:27–28, 2003.

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a study sponsored by Pharmacia, ironically titled CONVINCE:
B. M. Psaty and D. Rennie, “Stopping Medical Research to Save Money: A Broken Pact with Researchers and Patients,”
Journal of the American Medical Association
289:2128–2131, 2003.