Authors: Keith Wailoo
19
. For “threatened to transform â¦,” see George Annas, “Faith (Healing), Hope and Charity at the FDA: The Politics of AIDS Drug Trials,”
Villanova Law Review
34 (1989): 771â97; for “lurching from one crisis ⦔ and “three FDA employees â¦,” see Bruce Ingersoll and Gregory Stricharchuk, “Generic-Drug Scandal at FDA Is Linked to Deregulation Drive,”
Wall Street Journal
, September 13, 1989, A1; see also Richard Berke, “Deregulation Has Gone Too Far, Many Tell the New Administration,”
New York Times
, December 11, 1988, 1.
20
. Pilar Kraman,
Drug Abuse in AmericaâPrescription Drug Diversion
(Washington, D.C.: Council of State Governments, 2004); for “one New Mexico â¦,” see Pete Stark, “Not All Drug Lords Are Outlaws,” Op-Ed,
New York Times
, August 12, 1990, E21.
21
. For “prescription drug abuse â¦,” “how the legal distribution â¦,” and “a patient will present â¦,” see David Pesci, “Connecticut Q and A: William Ward, Ferreting Out Illegal Use of Legal Drugs,”
New York Times
, July 3, 1994, CN3; for “doctors who help â¦,” see Tim Golden, “Doctors Are Focus of Plan to Fight New Drug Laws,”
New York Times
, December 23, 1996, A10.
22
. For changing advertising, see Lawrence K. Altman, “Prescription Drugs Are Advertised to Patients, Breaking with Tradition,”
New York Times
, February 23, 1982, C1; for AMA concerns, see Michael Millenson, “New Pain Drug Ordered Too Readily, Group Says,”
Chicago Tribune
, March 7, 1983, 3.
23
. Elisabeth Rosenthal, “Maybe You're Sick. Maybe We Can Help,”
New York Times
, April 10, 1994, E2; for “a major concern â¦,” see Louis A. Morris and Lloyd G. Millstein, “Drug Advertising to Consumers: Effects of Formats for Magazine and Television Advertisements,”
Food Drug Cosmetics Law Journal
39 (1984): 497â503; see also Louis A. Morris et al., “Miscomprehension Rates for Prescription Drug Advertisements,”
Current Issues and Research in Advertising
9 (1986): 1, 93â117; for other manufacturer concerns, see Mary Jane Sheffet and Steven W. Kopp, “Advertising Prescription Drugs to the Public: Headache or Relief?”
Journal of Public Policy and Marketing
9 (1990): 42â61; for “increasing price competition â¦,” see Richard B. Schmitt, “Prescription Drug Ads Stir New Wave of Court Battles,”
Wall Street Journal
, October 4, 1994, B10. As this article noted, “In mid-August [1994], for example, a federal judge in Hartford, Conn., ordered Pfizer, Inc., to overhaul a campaign that criticized a new hypertension drug developed by the Miles unit of Bayer AG. The Miles drug, known as Adalat, threatened to undercut an established Pfizer treatment called Procardia.”
24
. See, for example, “Percodan Drug Bill Signed by Governor,”
Los Angeles Times
, May 19, 1965, 23; and Nan Robertson, “U.S. Tightens Rule on Sale of a Drug,”
New York Times
, December 29, 1963, 20.
25
. For sales and “if Grandma is placed â¦,” see Barry Meier and Melody Petersen, “Sales of Painkiller Grew Rapidly, but Success Brought a High Cost,”
New York Times
, May 5, 2001, A1. See also Christine L. Pasero, Margo McCaffery, and Lynda F. McKitrick, “Pain Control: Planning for Breakthrough Cancer Pain,”
American Journal of Nursing
96 (June 1996): 24; for “if the drug â¦,” see David Musto, “Boon for Pain Sufferers, and Thrill Seekers,” review of
Pain Killer: A âWonder' Drug's Trail of Addiction and Death
, by Barry Meier,
New York Times
, December 17, 2003, E9.
26
. For controlled release pill and “the interference of pain â¦,” see S. H. Roth, R. M. Fleischmann, F. X. Burch, F. Dietz, B. Bockow, R. J. Rapoport, J. Rutstein, P. G. Lacouture, “Around-the-Clock, Controlled-Release Oxycodone Therapy for Osteoarthritis-Related Pain: Placebo-Controlled Trial and Long-Term Evaluation,”
Archives of Internal Medicine
160 (2000): 853â60.
27
. For “a rash of armed â¦,” see National Public Radio, “OxyContin Robberies,”
All Things Considered
, August 23, 2001,
www.npr.org/templates/story/story.php?storyId=1127845
; for “ground zero â¦,” see Walt Schaefer, “OxyContin Use Said Likely to Spread,”
Cincinnati Enquirer
, February 10, 2001,
http://enquirer.com/editions/2001/02/10/loc_oxycontin_called.html
; see also Debbie Cenziper, “OxyContin Can Ease Pain, but for Abusers, It's Deadly,”
Charlotte Observer
, July 7, 2002; for the rise of methamphetamine, see Timothy Egan, “Meth Building Its Hell's Kitchen in Rural America,”
New York Times
, February 6, 2002, A14; and Jo Thomas, “Illegal Drug's Manufacture Puts Rural Areas at Risk,”
New York Times
, November 11, 2000, A9.
28
. For “brought relief to â¦,” see Frank R. Wolf, chair, Virginia, introducing the December 11, 2001 hearing.
Subcommittee of the Committee on Appropriations, House of Representatives
, 107th Congress, first session, part 10, OxyContin (Washington, D.C.: U.S. Government Printing Office, 2002), 3; for “as an academician â¦,” see J. David Haddox, letter to the editor,
New York Times
, March 9, 2001, A18; for arguments about exaggerated clinical fears, see
Interim Report: OxyContin C-II (Oxycodone HCl, Controlled-Release) Tablet and the Public Health (Purdue Pharma, December 7, 2001); Attachment 2 in Subcommittee of the Committee on Appropriations, House of Representatives
, 107th Congress, first session, part 10, OxyContin (Washington, D.C.: U.S. Government Printing Office, 2002).
29
. For litigation and OxyContin revenues, see Tim O'Brien, “OxyContin Suits Coming Up Empty: Purdue Pharma's Litigation Strategy Costly, but Effective,”
Connecticut Law Tribune
, October 27, 2003, 3; for deaths in Florida, see Vanita Gowda, “Not What the Doctor Ordered,”
Governing
16 (January 2003):
34; and Kraman,
Drug Abuse in America
; for regulators' focus, see T. Roche, “The potent perils of a miracle drug,”
Time
157 (2001): 47.
30
. For physician targeting, see Jill Barton, “Rush: I'm an Addict,”
Philadelphia Daily News
, October 11, 2003, 2; Robyn E. Blumner, “Limbaugh Scandal Puts OxyContin on Trial,”
St. Petersburg Times
, October 19, 2003, 7D; and Ralph Vartabedian, “Doctors Become Targets in Drug War,”
Chicago Tribune
, October 23, 2003, 22; for “the first time ⦔ and “media-induced hysteria,” see Ronald T. Libby, “Treating Doctors as Drug Dealers: The DEA's War on Prescription Painkillers,”
Cato Institute Policy Analysis Series
, no. 545, June 6, 2005.
www.cato.org/publications/policy-analysis/treating-doctors-drug-dealers-deas-war-prescription-painkillers
and Melinda Ammann, “The Agony and the Ecstacy,”
Reason
34, April 2003, 28â34.
31
. For “upscale junkies,” see Matthew Sweeney and Philip Messing, “Upscale JunkiesâWhite-Collar Abuse of Oxycontin Skyrockets,”
New York Post
, February 14, 2004, 19; for “college-aged kids,” see Natalie Hopkinson, “Addicted to âOxy': One Man's Struggle,”
Washington Post
, October 26, 2003, D1; for “migrating out of â¦,” see “Painkiller Sales Doubled in 8 Years,”
Bennington Banner
(Vermont), August 21, 2007; for “over the past several years â¦,”see Limbaugh quoted by Barton, “Rush: I'm an Addict,” 2; for “refreshing honesty,” see Howard Kurtz, “Limbaugh, Unbowed,”
Washington Post
, November 18, 2003, C1; for “beyond the damage â¦,” see Blumner, “Limbaugh Scandal Puts OxyContin on Trial,” 7D.
32
. United States House of Representatives Committee on Governmental ReformâMinority Staff Special Investigations Division,
FDA Enforcement Actions against False and Misleading Prescription Drug Advertisements Declined in 2003
(Washington D.C.: Government Printing Office, January 2004), 3.
33
. Ibid., 4.
34
. For “radio antennas â¦,” “bar code â¦,” and “we get calls â¦,” see Gardiner Harris, “Tiny Antennas to Keep Tabs on U.S. Drugs,”
New York Times
, November 15, 2004, A1; for “Purdue pledged â¦,” see Robert Trigaux, “Strong Dose of Hype for OxyContin Inexcusable,” review of
Pain Killer
, by Barry Meier,
St. Petersburg Times
, November 10, 2003, 1E.
35
. Amy Pavuk, “DEA: Walgreens Pushed Sales of Oxycodone,”
Orlando Sentinel
, June 29, 2013, A1.
36
. For the industry defense, see Joseph Prater, “West Virginia's Painful Settlement: How the OxyContin Phenomenon and Unconventional Theory of Tort Liability May Make Pharmaceutical Companies Liable for Black Markets,”
Northwestern University Law Review
(Spring 2006): 1418; for “it appeared that the plaintiffs â¦,” see Richard C. Ausness, “Product Liability's Parallel Universe:
Fault-Based Liability Theories and Modern Products Liability Law,”
Brooks Law Review
635 (2008â2009): 652.
37
. For resistance to high prices, see Milton Freudenheim and Melody Petersen, “The Drug Price Express Runs into a Wall,”
New York Times
, December 23, 2001, BU1; for the settlement, see Prater, “West Virginia's Painful Settlement,” 1425.
38
. Vioxx was one of the products heavily promoted by DTCA. See Julie M. Donohue, Maria Cevasco, and Meredith B. Rosenthal, “A Decade of Direct-to-Consumer Advertising of Prescription Drugs,”
New England Journal of Medicine
357 (August 16, 2007): 674. When the drug was withdrawn from the market in 2004, these authors noted, calls increased to place limits on the practice of DTCA, “particularly for new drugs, a view that was reiterated” in other reports; for SEC concerns, see Andrew Pollack, “Justice Dept. and S.E.C. Investigating Merck Drug,”
New York Times
, November 9, 2004, C1.
39
. On Kaiser and Bextra, see Gardiner Harris, “Big Health Plan Suspends Use of Painkiller,”
New York Times
, January 29, 2005, C1. On Enron and corporate malfeasance, see Kurt Eichenwald, “A Mini-Enron in Every Corner,”
New York Times
, May 29, 2005, B1. See also Barnaby Feder, “Merck's Actions on Vioxx Face New Scrutiny,”
New York Times
, February 15, 2005, C1.
40
. For adverse events, see David Spurgeon, “Serious Adverse Events Double in Seven Years in U.S.,”
British Medical Journal
335 (September 22, 2007): 585; for “the United States accounted for â¦,” see International Narcotics Control Board,
Report of the International Narcotics Control Board for 2008
(New York: United Nations, 2009), 20.
41
. For Merck settlement, see Alex Berenson, “Merck Is Said to Agree to Pay $4.85 Billion for Vioxx Claims,”
New York Times
, November 9, 2007, A1; for Pfizer settlement, see Stephanie Saul, “Pfizer in $894 Million Drug Settlement,”
New York Times
, October 18, 2008, B2; for Vioxx revenue and claims, see Karl Stark, “Merck Offers Billions for Vioxx Claims,”
McClatchy Tribune Business News
, November 10, 2007; Barry Meier, “Judge to Rule on Plea Deals of Executives in OxyContin Case,”
New York Times
, July 20, 2007, C2.
42
. 1.Press Release from Jill Kozeny for Chairman Chuck Grassley to Reporters and Editors, September 22, 2006.
43
. On the legal wrangling over Bush era torture policy, see Jane Mayer,
The Dark Side: The Inside Story of How the War on Terror Turned into a War on American Ideals
(New York: Anchor, 2009); “Vice President of Torture,” editorial,
Washington Post
, October 26, 2005, A18; Josh White and Charles Babbington, “House Supports Ban on Torture,”
Washington Post
, December 15, 2005, A1; Jeffrey Rosen, “Conscience of a Conservative,”
New York Times
, September
9, 2007, E40; Maureen Dowd, “Cheney, King of Pain,”
New York Times
, May 17, 2009, WK13; “The Torture Report,”
New York Times
, December 18, 2009, A42; Paul Krugman, “King of Pain,”
New York Times
, September 16, 2006, A27.
44
. Gina Pace, “Family Endures Pain of Soldier's Sacrifice,”
Citrus Times
(Florida), July 26, 2006.
45
. Gregg Zoroya, “Troops' Pain Meds Raise Concerns,”
USA Today
, October 21, 2008, 1A; see also Elizabeth Weise, “Soldiers in Iraq Carry Extra Load: Back Pain,”
USA Today
, November 21, 2005, 6D; Gregg Zoroya, “Abuse of Pain Pills Concerns Pentagon; Senate Eyes Leap to 3.8 M Prescriptions,”
USA Today
, March 17, 2010, 1A.
46
. For “has lost its way â¦,” see Senator Charles Grassley to Andrew C. von Eschenback, acting commissioner, FDA, September 20, 2006 (press release),
www.finance.senate.gov/newsroom/chairman/release/?id=86589465-6ce7-426c-9972-2e2c22b31200
; for “companies routinely promise â¦,” see Robert Pear, “Senate Approves Tighter Policing of Drug Makers,”
New York Times
, May 10, 2007, A1.
47
. For “it is an irony â¦,” see Sandy Rovner, “Panel Finds Hospitals Stingy with Pain Drugs,”
Washington Post
, May 28, 1986, H9. See, for example, A. G. Rogers, “The Underutilization of Oxycodone,”
Journal of Pain & Symptom Management
6 (1991): 452; for discussion of the pain divide, see Sean R. Morrison, Sylvan Wallenstein, Dana K. Natale, Richard S. Senzel, and Lo-Li Huang, “âWe Don't Carry That': Failure of Pharmacies in Predominantly Nonwhite Neighborhoods to Stock Opioid Analgesics,”
New England Journal of Medicine
342, no. 14 (April 6, 2000): 1023â26. As the authors noted, an array of “studies of diverse populations of patients have found that unrelieved pain is highly prevalent, especially among minority groups.” See also R. Bernabei et al., “Management of Pain in Elderly Patients with Cancer,”
Journal of the American Medical Association
279 (1998): 1877â82; C. S. Cleeland, R. Gonin, and A. K. Hatfield, “Pain and Its Treatment in Outpatients with Metastatic Cancer,”
New England Journal of Medicine
330 (1994): 592â96. On minority differences, see C. S. Cleeland et al., “Pain and Treatment of Pain in Minority Patients with Cancer: The Eastern Cooperative Oncology Group Minority Outpatient Pain Study,”
Annals of Internal Medicine
127 (1997): 813â16; K. Todd, N. Samaroo, and J. R. Hoffman, “Ethnicity as a Risk Factor for Inadequate Emergency Department Analgesia,”
Journal of the American Medical Association
269 (1993): 1537â39; and D. D. McDonald, “Gender and Ethnic Stereotyping and Narcotic Analgesic Administration,”
Research in Nursing and Health
17 (1994): 45â49; for “physicians sometimes think â¦,” see W. P. Buchanan, Peter C. Ungaro, and Jane E. Ranney, “Objective Laboratory Parameters in the Diagnosis of Sickle-Cell Pain Crisis,”
North Carolina Medical Journal
49 (November 1988): 583â84. See also Keith Wailoo,
Dying in the City of the Blues: Sickle Cell Anemia and the Politics of Race and Health
(Chapel Hill: University of North Carolina Press, 2001); and Keith Wailoo and Stephen Pemberton,
The Troubled Dream of Genetic Medicine
(Baltimore: Johns Hopkins University Press, 2008).