OxyContin, a controlled-release opioid developed and produced by Purdue Pharma, was given Food and Drug Administration (FDA) approval in December 1995. By 1999, to the apparent surprise of Purdue Pharma, the Drug Enforcement Administration (DEA), and the FDA, extensive reports of OxyContin abuse and diversion began to circulate. The drug abuse assessment liability system in the United States has often been criticized and the experience with OxyContin did nothing but buttress those criticisms. However, as seven investigational hearings conducted by the U.S. Congress would expose, several changes were made to the abuse liability assessment to correct deficiencies in the system which had aggravated OxyContin abuse and diversion—a welcome sign from what many have considered an American tragedy.
AbrahmJ. (2005, September13). Testimony before the Subcommittee on Regulatory Affairs of the Committee on Government Reform of the House of Representatives.
2.
ArfkenC. L.CiceroT. J. (2003). Postmarketing surveillance for drug abuse. Drug and Alcohol Dependence, 70, S97-S105.
3.
ArfkenC. L.SchusterC. A.JohansonC. (2003). Postmarketing surveillance of abuse liability of sibutramine. Drug and Alcohol Dependence, 69, 169-173.
4.
BallentineC. (1981, June). Taste of raspberries, taste of death: The 1937 elixir sulfanilamide incident. FDA Consumer Magazine, 18-21.
5.
BalsterR. L.BigelowG. E. (2003). Guidelines and methodological reviews concerning drug abuse liability assessment. Drug and Alcohol Dependence, 70, S13-S40.
6.
BaumC.HsuJ. P.NelsonR. C. (1987). The impact of the addiction of naloxone on the use and abuse of pentazocine. Public Health Reports, 102, 426-429.
7.
BaumruckerS. J. (2001). OxyContin, the media, and law enforcement. American Journal of Hospice & Palliative Care, 18, 154-156.
8.
BradyK. T.LydiardR. B.BradyJ. V. (2003). Assessing abuse liability in clinical trials. Drug and Alcohol Dependence, 70, S87-S95.
9.
CariseD.DugoshK. L.McLellanA. T.CamilleriA.WoodyG. E.LynchK. G. (2007). Prescription OxyContin abuse among patients entering addiction treatment. American Journal of Psychiatry, 164, 1750-1756.
10.
CiceroT. (2006, June21). Interview by N. Campbell & J. Spillane, Substance Abuse Research Center, University of Michigan, Ann Arbor.
11.
CiceroT. J.AdamsE. H.GellerA.InciardiJ. A.MunozA.SchnollS. H.WoodyG. E. (1999). A postmarketing surveillance program to monitor Ultram (tramadol hydrochloride) abuse in the United States. Drug and Alcohol Dependence, 57, 7-22.
12.
CiceroT. J.InciardiJ. A.MunozA. (2005). Trends in abuse of OxyContin and other opioid analgesics in the United States: 2002-2004. Journal of Pain, 6, 662-672.
13.
CourtwrightD. (2001). Forces of habit: Drugs and the making of the modern world. Cambridge, MA: Harvard University Press.
14.
DoddC. (2002, February12). Testimony before the Committee on Health, Education, Labor, and Pensions of the United States Senate.
15.
FriedmanM. (2001, August28). Testimony before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce of the House of Representatives.
16.
GlareP.WalshT. D. (1993). Dose-ranging study of oxycodone for chronic pain in advanced cancer. Journal of Clinical Oncology, 11, 973-978.
17.
GoldenheimP. (2001, December11). Testimony before the Subcommittee on Appropriations of the House of Representatives.
18.
GoldenheimP. (2002, February12). Testimony before the Committee on Health, Education, Labor, and Pensions of the United States Senate.
19.
GreenwoodJ. C. (2001, August28). Testimony before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce of the House of Representatives.
20.
GriffinO. H.IIIMillerB. L. (2011). OxyContin and a regulation deficiency of the pharmaceutical industry: Rethinking state-corporate crime. Critical Criminology: An International Journal, 19, 213-226.
21.
GriffithsR. R.BigelowG. L.AtorN. A. (2003). Principles of initial experimental drug abuse liability assessment in humans. Drug and Alcohol Dependence, 70, S41-S54.
22.
HawthorneF. (2005). Inside the FDA: The business and politics behind the drugs we take and the food we eat. Hoboken, NJ: John Wiley.
23.
InciardiJ. A.GoodeJ. L. (2003). OxyContin and prescription drug abuse: Miracle medicine or problem drug. Consumers’ Research, 7, 17-21.
24.
JacksonC. O. (1971). The amphetamine inhaler: A case study of medical abuse. Journal of the History of Medicine, 26, 187-196.
25.
JaffeJ. H.BloorR.CromeI.CarrM.AlamF.SimmonsA.MeyerR. E. (2004). A postmarketing study of relative abuse liability of hypnotic sedative drugs. Addiction, 99, 165-173.
26.
JenkinsJ. (2002, February12). Testimony before the Committee on Health, Education, Labor, and Pensions of the United States Senate.
27.
KalsoE.VainioA. (1990). Morphine and oxycodone hydrochloride in the management of cancer pain. Clinical Pharmacology & Therapeutics, 47, 639-646.
28.
KniselyJ. S.CampbellE. D.DawsonK. S.SchnollS. H. (2002). Tramadol postmarketing surveillance in health care professionals. Drug and Alcohol Dependence, 68, 15-22.
29.
KwederS. (2006, July26). Testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources of the Committee on Government Reform of the House of Representatives.
30.
LevyM. H. (1996). Pharmacologic treatment of cancer pain. New England Journal of Medicine, 335, 1124-1132.
31.
LevyM. H. (2001a). Advancement of opioid analgesia with controlled-release oxycodone. European Journal of Pain, 5, 113-116.
32.
LevyM. H. (2001b, August28). Testimony before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce of the House of Representatives.
33.
MadrasB. (2006, July26). Testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources of the Committee on Government Reform of the House of Representatives.
34.
MeierB. (2003). Pain killer: A “wonder” drug’s trail of addiction and death. New York, NY: Rodale.
35.
MeyerR. (2004, February9). Testimony before the Subcommittee on Criminal Justice, Drug Policy and Human Resources of the Committee on Government Reform of the House of Representatives.
36.
MeyerR. (2005, September13). Testimony before the Subcommittee on Regulatory Affairs of the Committee on Government Reform of the House of Representatives.
37.
PoklisA. (1984). Decline in abuse of pentazocine/tripelennamine (T’s and blues) associated with the addition of naloxone to pentazocine tablets. Drug and Alcohol Dependence, 14, 135-140.
38.
RasmussenN. (2008). America’s first amphetamine epidemic 1929-1971: A quantitative and qualitative retrospective with implications for the present. American Journal of Public Health, 98, 974-985.
39.
SchnollS. (2008, June19). Interview by N. Campbell & J. Spillane, Substance Abuse Research Center, University of Michigan, Ann Arbor.
40.
SeesK. L.MarinoD.MichaelE.RuedigerN. K.SweeneyC. T.ShiffmanS. (2005). Non-medical use of OxyContin tablets in the United States. Journal of Pain & Palliative Care Pharmacotherapy, 19, 13-23.
41.
ShowalterC. V. (1980). T’s and blues: Abuse of pentazocine and tripelennamine. Journal of the American Medical Association, 244, 1224-1225.
42.
SpillaneJ. F. (2000). Cocaine: From medical marvel to modern day menace in the United States 1884-1920. Baltimore, MD: Johns Hopkins University Press.
43.
SullivanR. (2001, December11). Testimony before the Subcommittee on Appropriations of the House of Representatives.
44.
SutherlandE. H. (1940). White-collar criminality. American Sociological Review, 5, 1-12.
45.
TunnellK. D. (2005). The OxyContin epidemic and crime panic in rural Kentucky. Contemporary Drug Problems, 32, 225-258.
46.
United States General Accounting Office. (2003). Prescription drugs: OxyContin abuse and diversion and efforts to address the problem (GAO-04-110). Washington, DC: U.S. Government Printing Office.
47.
Van ZeeA. (2009). The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. American Journal of Public Health, 99, 221-227.
48.
WaxP. M. (1995). Elixirs, diluents, and the passage of the 1939 Federal Food, Drug and Cosmetic Act. Annals of Internal Medicine, 122, 456-461.
49.
WoodyG. E.SenayE. C.GellerA.AdamsE. H.InciardiJ. A.SchnollS.CiceroT. J. (2003). An independent assessment of MEDWATCH reporting for abuse/dependence and withdrawal from Ultram (tramadol hydrochloride). Drug and Alcohol Dependence, 72, 163-168.
50.
WrightI. V.KramerE. D. C.ZalmanM.SmithM. Y.HaddoxJ. D. (2006). Risk identification, risk assessment, and risk management of abusable drug formulations. Drug and Alcohol Dependence, 83S, S68-S76.
