You are on page 1of 7

HEALTH POLICY AND ETHICS

6. Mamlin J, Kimaiyo S, Nyandiko W, power of an academic medical partner- tance Project, Academy for Educational
Tierney W, Einterz R. Academic Institu- ship. Acad Med. 2007;82:812–818. Development; 2006.
tions Linking Access to Treatment and 8. Coates J, Swindale A, Bilinsky P.
Prevention: Case Study. Geneva, Switzer- Household Food Insecurity Access Scale 9. Marston B, De Cock K. Multivitamins,
land: World Health Organization; 2004. (HFIAS) for Measurement of Household nutrition, and antiretroviral therapy for
7. Einterz R, Kimaiyo S, Mengech H, et al. Food Access: Indicator Guide. Washington, HIV disease in Africa. N Engl J Med.
Responding to the HIV pandemic: the DC: Food and Nutrition Technical Assis- 2004;351:78–80.

The Promotion and Marketing of OxyContin: Commercial


Triumph, Public Health Tragedy
Art Van Zee, MD

I focus on issues surround- prescribed. An in-depth analysis of of the drug compared with other The promotion and marketing
ing the promotion and market- the promotion and marketing of available opioid preparations. The of OxyContin occurred during a
ing of controlled drugs and OxyContin (Purdue Pharma, Medical Letter on Drugs and Ther- recent trend in the liberalization of
their regulatory oversight. Stamford, CT), a sustained-release apeutics concluded in 2001 that the use of opioids in the treatment
Compared with noncontrolled oxycodone preparation, illustrates oxycodone offered no advantage of pain, particularly for chronic
drugs, controlled drugs, with
some of the key issues. When over appropriate doses of other non–cancer-related pain. Purdue
their potential for abuse and
Purdue Pharma introduced Oxy- potent opioids.3 Randomized dou- pursued an ‘‘aggressive’’ campaign
diversion, pose different pub-
lic health risks when they are Contin in 1996, it was aggressively ble-blind studies comparing Oxy- to promote the use of opioids in
overpromoted and highly pre- marketed and highly promoted. Contin given every 12 hours with general and OxyContin in partic-
scribed. An in-depth analysis Sales grew from $48 million in immediate-release oxycodone given ular.1,12–17 In 2001 alone, the com-
of the promotion and market- 1996 to almost $1.1 billion in 4 times daily showed comparable pany spent $200 million18 in an
ing of OxyContin illustrates 2000.1 The high availability of efficacy and safety for use with array of approaches to market and
some of the associated issues. OxyContin correlated with in- chronic back pain4 and cancer- promote OxyContin.
Modifications of the promo- creased abuse, diversion, and ad- related pain.5,6 Randomized
tion and marketing of controlled diction, and by 2004 OxyContin double-blind studies that compared PROMOTION OF
drugs by the pharmaceutical had become a leading drug of abuse OxyContin with controlled-release OXYCONTIN
industry and an enhanced ca-
in the United States.2 morphine for cancer-related pain
pacity of the Food and Drug
Under current regulations, the also found comparable efficacy From 1996 to 2001, Purdue
Administration to regulate and
monitor such promotion can Food and Drug Administration and safety.7–9 The FDA’s medical conducted more than 40 national
have a positive impact on the (FDA) is limited in its oversight of review officer, in evaluating the pain-management and speaker-
public health. (Am J Public the marketing and promotion of efficacy of OxyContin in Purdue’s training conferences at resorts in
Health. 2009;99:221–227. doi: controlled drugs. However, fun- 1995 new drug application, con- Florida, Arizona, and California.
10.2105/AJPH.2007.131714) damental changes in the promo- cluded that OxyContin had not More than 5000 physicians,
tion and marketing of controlled been shown to have a significant pharmacists, and nurses attended
CONTROLLED DRUGS, WITH drugs by the pharmaceutical in- advantage over conventional, these all-expenses-paid symposia,
their potential for abuse and di- dustry, and an enhanced capacity immediate-release oxycodone where they were recruited and
version, can pose public health of the FDA to regulate and mon- taken 4 times daily other than a trained for Purdue’s national
risks that are different from—and itor such promotion, can positively reduction in frequency of dosing.10 speaker bureau.19(p22) It is well
more problematic than—those of affect public health. In a review of the medical literature, documented that this type of phar-
uncontrolled drugs when they OxyContin’s commercial suc- Chou et al. made similar conclu- maceutical company symposium
are overpromoted and highly cess did not depend on the merits sions.11 influences physicians’ prescribing,

February 2009, Vol 99, No. 2 | American Journal of Public Health Van Zee | Peer Reviewed | Health Policy and Ethics | 221
HEALTH POLICY AND ETHICS

even though the physicians who incentive bonuses to its sales rep-
attend such symposia believe that resentatives that year.19 TABLE 1—Distribution of OxyContin, Oxycodone (Excluding
such enticements do not alter their From 1996 to 2000, Purdue OxyContin), and Hydrocodone per 100 000 Population:
prescribing patterns.20 increased its internal sales force Virginia, West Virginia, and Kentucky, 2000
One of the cornerstones of from 318 sales representatives to Distribution in Grams per 100 000 Population
Purdue’s marketing plan was the 671, and its total physician call list
Oxycodone
use of sophisticated marketing from approximately 33 400 to State and County OxyContin (Excluding OxyContin) Hydrocodone
data to influence physicians’ pre- 44 500 to approximately 70 500
scribing. Drug companies compile to 94 000 physicians.19 Through Virginia
prescriber profiles on individual the sales representatives, Purdue Dickenson 25 801 2 777 16 692
physicians—detailing the prescrib- used a patient starter coupon pro- Lee 23 398 6 232 8 445
ing patterns of physicians nation- gram for OxyContin that provided Buchanan 19 138 3 235 15 996
wide—in an effort to influence patients with a free limited-time Scott 18 328 4 946 12 274
doctors’ prescribing habits. prescription for a 7- to 30-day Roanoke City 17 856 2 808 7 201
Through these profiles, a drug supply. By 2001, when the pro- Tazewell 17 135 3 482 27 714
company can identify the highest gram was ended, approximately Winchester City 15 242 6 764 14 057
and lowest prescribers of particu- 34 000 coupons had been Manassas City 14 735 5 920 5 511
lar drugs in a single zip code, redeemed nationally.19 Fauquier 14 396 6 935 4 434
county, state, or the entire coun- The distribution to health care Wythe 14 236 3 165 8 812
try.21 One of the critical foundations professionals of branded promo- Kentucky
of Purdue’s marketing plan for tional items such as OxyContin Cumberland 22 113 1 486 8 148
OxyContin was to target the physi- fishing hats, stuffed plush toys, and Perry 20 996 6 145 27 413
cians who were the highest pre- music compact discs (‘‘Get in the Harlan 19 359 3 121 10 141
scribers for opioids across the Swing With OxyContin’’) was un- Leslie 18 221 4 017 16 925
country.1,12–17,22 The resulting da- precedented for a schedule II opi- Whitley 13 438 3 410 19 532
tabase would help identify physi- oid, according to the Drug En- Greenup 13 222 5 151 44 872
cians with large numbers of forcement Administration.19 McCreary 12 573 3 026 12 996
chronic-pain patients. Unfortu- Purdue promoted among pri- Clinton 12 517 2 911 14 892
nately, this same database would mary care physicians a more lib- Bell 11 739 3 118 26 037
also identify which physicians were eral use of opioids, particularly Clay 11 563 3 260 21 093
simply the most frequent pre- sustained-release opioids. Primary West Virginia
scribers of opioids and, in some care physicians began to use more Pocahontas 17 318 3 605 17 651
cases, the least discriminate pre- of the increasingly popular Oxy- Raleigh 16 813 5 959 8 718
scribers. Contin; by 2003, nearly half of all Berkeley 16 299 5 254 5 009
A lucrative bonus system en- physicians prescribing OxyContin Logan 16 153 2 224 22 950
couraged sales representatives to were primary care physicians.19 McDowell 15 770 3 200 24 235
increase sales of OxyContin in Some experts were concerned that Greenbrier 15 752 2 539 12 380
their territories, resulting in a large primary care physicians were not Mercer 15 040 3 306 21 175
number of visits to physicians with sufficiently trained in pain manage- Hancock 13 465 4 327 8 831
high rates of opioid prescriptions, ment or addiction issues.23 Primary Harrison 12 409 3 407 12 658
as well as a multifaceted informa- care physicians, particularly in a Cabell 11 665 3 608 13 018
tion campaign aimed at them. In managed care environment of time US average 3 750 1 761 5 083
2001, in addition to the average constraints, also had the least Source. Office of Diversion Control, Drug Enforcement Administration.67
sales representative’s annual sal- amount of time for evaluation and Note. Data are for the counties or independent cities with the highest quantities of
ary of $55 000, annual bonuses follow-up of patients with compli- opioids (in grams) prescribed in each of the 3 states.
averaged $71500, with a range of cated chronic pain.
$15 000 to nearly $240 000. Purdue ‘‘aggressively’’ pro-
Purdue paid $40 million in sales moted the use of opioids for use in

222 | Health Policy and Ethics | Peer Reviewed | Van Zee American Journal of Public Health | February 2009, Vol 99, No. 2
HEALTH POLICY AND ETHICS

the ‘‘non-malignant pain mar- hormonal and immune effects of treated with opioids. Both of these prescriptions dispensed) in 1996 to
ket.’’15(p187) A much larger market long-term opioid treatment; a high studies, although shedding some a 2001 and 2002 combined sales
than that for cancer-related pain, incidence of prescription opioid light on the risk of addiction for of nearly $3 billion (over 14 million
the non–cancer-related pain market abuse behaviors; and an ill- acute pain, do not help establish the prescriptions).19
constituted 86% of the total opioid defined and unclarified risk of risk of iatrogenic addiction when The remarkable commercial
market in 1999.17 Purdue’s promo- iatrogenic addiction.40 opioids are used daily for a pro- success of OxyContin, however,
tion of OxyContin for the treatment longed time in treating chronic pain. was stained by increasing rates
of non–cancer-related pain con- MISREPRESENTING THE There are a number of studies, of abuse and addiction. Drug
tributed to a nearly tenfold increase RISK OF ADDICTION however, that demonstrate that in abusers learned how to simply
in OxyContin prescriptions for this the treatment of chronic non– crush the controlled-release
type of pain, from about 670000 in A consistent feature in the pro- cancer-related pain with opioids, tablet and swallow, inhale, or in-
1997 to about 6.2 million in 2002, motion and marketing of Oxy- there is a high incidence of pre- ject the high-potency opioid for
whereas prescriptions for cancer- Contin was a systematic effort scription drug abuse. Prescription an intense morphinelike high.64
related pain increased about four- to minimize the risk of addiction drug abuse in a substantial minority There had been some precedence
fold during that same period.19 Al- in the use of opioids for the treat- of chronic-pain patients has been for the diversion and abuse of con-
though the science and consensus ment of chronic non–cancer-re- demonstrated in studies by trolled-release opioid preparations.
for the use of opioids in the treat- lated pain. One of the most critical Fishbain et al. (3%–18% of pa- Purdue’s own MS Contin had been
ment of acute pain or pain associ- issues regarding the use of opioids tients),53 Hoffman et al. (23%),54 abused in the late 1980s in a fash-
ated with cancer are robust, there is in the treatment of chronic non– Kouyanou et al. (12%),55 Chabal ion similar to how OxyContin was
still much controversy in medicine cancer-related pain is the potential et al. (34%),56 Katz et al. (43%),57 later to be; by 1990, MS Contin had
about the use of opioids for chronic of iatrogenic addiction. The life- Reid et al. (24%–31%),58 and become the most abused prescrip-
non–cancer-related pain, where time prevalence of addictive dis- Michna et al. (45%).59 A recent tion opioid in one major metropol-
their risks and benefits are much orders has been estimated at 3% literature review showed that the itan area.65 Purdue’s own testing in
less clear. Prospective, randomized, to 16% of the general popula- prevalence of addiction in patients 1995 had demonstrated that 68%
controlled trials lasting at least 4 tion.41 However, we lack any large, with long-term opioid treatment for of the oxycodone could be ex-
weeks that evaluated the use of methodically rigorous prospective chronic non–cancer-related pain tracted from an OxyContin tablet
opioids for chronic, non–cancer-re- study addressing the issue of iatro- varied from 0% to 50%, depending when crushed.66
lated pain showed statistically sig- genic addiction during long-term on the criteria used and the sub- Opioid prescribing has had
nificant but small to modest im- opioid use for chronic nonmalig- population studied.60 significant geographical varia-
provement in pain relief, with no nant pain.42 Misrepresenting the risk of ad- tions. In some areas, such as
consistent improvement in physical In much of its promotional diction proved costly for Purdue. Maine, West Virginia, eastern
functioning.24–38 A recent review campaign—in literature and au- On May 10, 2007, Purdue Fred- Kentucky, southwestern Vir-
of the use of opioids in chronic back diotapes for physicians, brochures erick Company Inc, an affiliate of ginia, and Alabama, from 1998
pain concluded that opioids may be and videotapes for patients, and its Purdue Pharma, along with 3 through 2000, hydrocodone and
efficacious for short-term pain relief, ‘‘Partners Against Pain’’ Web company executives, pled guilty to (non-OxyContin) oxycodone
but longer-term efficacy ( >16 site—Purdue claimed that the risk criminal charges of misbranding were being prescribed 2.5 to 5.0
weeks) is unclear.39 of addiction from OxyContin was OxyContin by claiming that it was times more than the national
In the long-term use of opioids extremely small.43–49 less addictive and less subject to average. By 2000, these same
for chronic non–cancer-related Purdue trained its sales repre- abuse and diversion than other areas had become high Oxy-
pain, the proven analgesic efficacy sentatives to carry the message opioids, and will pay $634 million Contin-prescribing areas—up to
must be weighed against the fol- that the risk of addiction was ‘‘less in fines.61 5 to 6 times higher than the
lowing potential problems and than one percent.’’50(p99) The Although research demon- national average in some
risks: well-known opioid side ef- company cited studies by Porter strated that OxyContin was com- counties (Table 1).67 These areas,
fects, including respiratory de- and Jick,51 who found iatrogenic parable in efficacy and safety to in which OxyContin was highly
pression, sedation, constipation, addiction in only 4 of 11882 pa- other available opioids,11,63 mar- available, were the first in the na-
and nausea; inconsistent im- tients using opioids and by Perry keting catapulted OxyContin to tion to witness increasing OxyCon-
provement in functioning; opioid- and Heidrich,52 who found no ad- blockbuster drug status. Sales esca- tin abuse and diversion, which be-
induced hyperalgesia; adverse diction among 10 000 burn patients lated from $44 million (316000 gan surfacing in 1999 and 2000.23

February 2009, Vol 99, No. 2 | American Journal of Public Health Van Zee | Peer Reviewed | Health Policy and Ethics | 223
HEALTH POLICY AND ETHICS

From 1995 to 2001, the number communication, January 12, abusers of prescription opioids get for example, 39 FDA staff
of patients treated for opioid abuse 2007). The high availability of their diverted drugs directly from a members were responsible for
in Maine increased 460%, and OxyContin in these 5 regions doctor’s prescription or from the reviewing roughly 34 000 pieces
from 1997 to 1999 the state had seemed to be a simple correlate of prescriptions of friends and fam- of promotional materials.19 This
a 400% increase in the number its abuse, diversion, and addiction. ily.73 limited staffing significantly dimin-
of chronic hepatitis C cases With the growing availability of In terms of illicit drug abuse, ishes the FDA’s ability to ensure
reported.68 In eastern Kentucky OxyContin prescriptions, the once- prescription opioids are now that the promotion is truthful,
from 1995 to 2001, there was a regional problem began to spread ahead of cocaine and heroin and balanced, and accurately commu-
500% increase in the number of nationally. By 2002, OxyContin second only to marijuana.72 Mor- nicated.
patients entering methadone main- accounted for 68% of oxycodone tality rates from drug overdose In 1998, Purdue distributed
tenance treatment programs, about sales.69 Lifetime nonmedical use have climbed dramatically; by 15 000 copies of an OxyContin
75% of whom were OxyContin of OxyContin increased from 1.9 2002, unintentional overdose video to physicians without sub-
dependent (Mac Bell, administrator, million to 3.1 million people be- deaths from prescription opioids mitting it to the FDA for review, an
Narcotics Treatment Programs, tween 2002 and 2004, and in surpassed those from heroin and oversight later acknowledged by
Kentucky Division of Substance 2004 there were 615000 new cocaine nationwide.74 Nationally, Purdue. In 2001, Purdue submit-
Abuse, written communication, nonmedical users of OxyContin.70 as well as regionally, the high ted to the FDA a second version of
March 2002). In West Virginia, the By 2004, OxyContin had be- availability of OxyContin and all the video, which the FDA did not
first methadone maintenance treat- come the most prevalent prescrip- prescription opioids was corre- review until October 2002—after
ment program opened in August tion opioid abused in the United lated with high rates of abuse and the General Accounting Office in-
2000, largely in response to the States.2 diversion. quired about its content. After its
increasing number of people with The increasing OxyContin review, the FDA concluded that
OxyContin dependence. By Octo- abuse problem was an integral THE FOOD AND DRUG the video minimized the risks from
ber 2003, West Virginia had 7 part of the escalating national ADMINISTRATION OxyContin and made unsubstan-
methadone maintenance treatment prescription opioid abuse prob- tiated claims regarding its benefits
clinics with 3040 patients in treat- lem. Liberalization of the use of Under the Food, Drug, and to patients.19
ment (M. Moore, Office of Behav- opioids, particularly for the treat- Cosmetics Act and implementing When OxyContin entered the
ioral Health Services, Office of Al- ment of chronic non–cancer- regulations, the FDA regulates the market in 1996, the FDA ap-
coholism and Drug Abuse, West related pain, increased the avail- advertising and promotion of pre- proved its original label, which
Virginia, written communication, ability of all opioids as well as their scription drugs and is responsible stated that iatrogenic addiction
March 16, 2004). In southwestern abuse. Nationwide, from 1997 to for ensuring that prescription drug was ‘‘very rare’’ if opioids were
Virginia, the first methadone main- 2002, there was a 226%, 73%, advertising and promotion are legitimately used in the man-
tenance treatment program opened and 402% increase in fentanyl, truthful, balanced, and accurately agement of pain. In July 2001, to
in March 2000, and within 3 years morphine, and oxycodone pre- communicated. There is no dis- reflect the available scientific
it had 1400 admissions (E. Jennings, scribing, respectively (in grams per tinction in the act between con- evidence, the label was modified
Life Center of Galax, Galax, Vir- 100 000 population). During that trolled and noncontrolled drugs to state that data were not
ginia, written communication, same period, the Drug Abuse regarding the oversight of promo- available for establishing the
March 12, 2004). Warning Network reported that tional activities. Although regula- true incidence of addiction in
With increasing diversion and hospital emergency department tions require that all promotional chronic-pain patients. The 2001
abuse, opioid-related overdoses mentions for fentanyl, morphine, materials for prescription drugs be labeling also deleted the origi-
escalated. In southwest Virginia, and oxycodone increased 641%, submitted to the FDA for review nal statement that the delayed
the number of deaths related to 113%, and 346%, respectively.71 when the materials are initially absorption of OxyContin was
opioid prescriptions increased Among new initiates to illicit drug disseminated or used, it is gener- believed to reduce the abuse
830%, from 23 in 1997 to 215 use in 2005, a total of 2.1 million ally not required that these mate- liability of the drug.19 A more
in 2003 (William Massello III, reported prescription opioids as the rials be approved by the FDA thorough review of the available
MD, assistant chief medical exam- first drug they had tried, more than prior to their use. The FDA has a scientific evidence prior to the
iner, Office of Chief Medical Ex- for marijuana and almost equal to limited number of staff for over- original labeling might have pre-
aminer, Western District, Virginia the number of new cigarette seeing the enormous amount of vented some of the need for the
Department of Health, written smokers (2.3 million).72 Most promotional materials. In 2002, 2001 label revision.

224 | Health Policy and Ethics | Peer Reviewed | Van Zee American Journal of Public Health | February 2009, Vol 99, No. 2
HEALTH POLICY AND ETHICS

CONCLUSIONS crafted limits on the marketing and prescribing by some physicians— contributed to the marked growth
promotion of controlled drugs perhaps the most liberal prescribers of opioid abuse in the United
OxyContin appears to be as ef- would help to realign their actual of opioids and, in some cases, the States, but one factor is certainly
ficacious and safe as other avail- use with the principles of evidence- least discriminate. Regulations the much increased availability of
able opioids and as oxycodone based medicine. eliminating this marketing tool prescription opioids.78 The public
taken 4 times daily.11,63 Its com- Physicians’ interactions with might decrease some potential interest and public health would be
mercial success, fueled by an un- pharmaceutical sales representa- overprescribing of controlled drugs. better served by a redefinition of
precedented promotion and mar- tives have been found to influence The public health would be acceptable and allowable marketing
keting campaign, was stained by the prescribing practices of resi- better protected if the FDA practices for opioids and other
escalating OxyContin abuse and dents and physicians in terms of reviewed all advertising and pro- controlled drugs. j
diversion that spread throughout decreased prescribing of generic motional materials as well as as-
the country.2,75 The regions of the drugs, prescribing cost, nonratio- sociated educational materials— About the Author
country that had the earliest and nal prescribing, and rapid pre- for their truthfulness, accuracy, Requests for reprints should be sent to
Art Van Zee, MD, Stone Mountain Health
highest availability of prescribed scribing of new drugs.76 Carefully balance, and scientific validity— Services, St Charles Clinic, Box S, St
OxyContin had the greatest initial crafted limits on the promotion of before dissemination. Such a Charles, VA 24282 (e-mail: artvanzee@
abuse and diversion.23,67 Nation- controlled drugs by the pharma- change would require a consider- adelphia.net).
This article was accepted May 9, 2008.
ally, the increasing availability of ceutical sales force and enhanced able increase in FDA support,
OxyContin was associated with FDA oversight of the training and staffing, and funding from what is
Acknowledgments
higher rates of abuse, and it became performance of sales representa- currently available. Public monies I thank Michael McNeer, MD, for his
the most prevalent abused pre- tives would also reduce over- and spent on the front end of the thoughtful review of the essay and helpful
scription opioid by 2004.2 misprescribing. problem could prevent another suggestions.

Compared with noncontrolled Although there are no available such tragedy.


drugs, controlled drugs, with their data for evaluating the promo- The pharmaceutical industry’s
References
potential for abuse and diversion, tional effect of free starter coupons role and influence in medical ed- 1. ‘‘OxyContin Marketing Plan, 2002.’’
pose different public health risks for controlled drugs, it seems ucation is problematic. From 1996 Purdue Pharma, Stamford, CN, 2002.
when overpromoted and highly likely that the over- and mispre- through July 2002, Purdue 2. Cicero T, Inciardi J, Munoz A. Trends in
prescribed. Several marketing scribing of a controlled drug are funded more than 20 000 pain- abuse of OxyContin and other opioid
analgesics in the United States: 2002–
practices appear to be especially encouraged by such promotional related educational programs 2004. J Pain. 2005;6:662–672.
questionable. programs and the public health through direct sponsorship or fi- 3. Oxycodone and OxyContin. Med Lett
The extraordinary amount of would be well served by eliminat- nancial grants,19 providing a venue Drugs Ther. 2001;43:80–81.
money spent in promoting a sus- ing them. that had enormous influence on 4. Hale ME, Fleischmann R, Salzman R,
tained-release opioid was unprec- The use of prescriber profiling physicians’ prescribing throughout et al. Efficacy and safety of controlled-
release versus immediate-release oxyco-
edented. During OxyContin’s first data to influence prescribing and the country. Particularly with con- done: randomized, double-blind evalua-
6 years on the market, Purdue improve sales is imbedded in trolled drugs, the potential for tion in chronic back pain. Clin J Pain.
spent approximately 6 to 12 times pharmaceutical detailing. Very lit- blurring marketing and education 1999;15:179–183.
more on promoting it than the tle data are publicly available for carries a much higher public health 5. Kaplan R, Parris WC, Citron MI, et al.
Comparison of controlled-release and
company had spent on promoting understanding to what extent this risk than with uncontrolled drugs.
immediate-release oxycodone in cancer
MS Contin, or than Janssen Phar- marketing practice boosts sales. At least in the area of controlled pain. J Clin Oncol. 1998;16:3230–3237.
maceutical Products LP had spent One market research report indi- drugs, with their high potential for 6. Staumbaugh JE, Reder RF,
on Duragesic, one of OxyContin’s cated that profiling improved abuse and diversion, public health Stambaugh MD, et al. Double-blind, ran-
domized comparison of the analgesic and
competitors.19 Although OxyCon- profit margins by as much as 3 would best be served by severing the
pharmacokinetic profiles of controlled-
tin has not been shown to be su- percentage points and the initial pharmaceutical industry’s direct role and immediate-release oral oxycodone in
perior to other available potent uptake of new drugs by 30%.77 and influence in medical education. cancer pain patients. J Clin Pharmacol.
2001;41:500–506.
opioid preparations,11,63 by 2001 it The use of prescriber profiling data Marketing and promotion by
had become the most frequently to target high-opioid prescribers— the pharmaceutical industry have 7. Heiskanen T, Kalso E. Controlled-re-
lease oxycodone and morphine in cancer
prescribed brand-name opioid in coupled with very lucrative incen- considerably amplified the pre- related pain. Pain. 1997;73:37–45.
the United States for treating mod- tives for sales representatives— scription sales and availability of 8. Mucci-LoRusso P, Berman BS,
erate to severe pain.19 Carefully would seem to fuel increased opioids. A number of factors have Silberstein PT, et al. Controlled-release

February 2009, Vol 99, No. 2 | American Journal of Public Health Van Zee | Peer Reviewed | Health Policy and Ethics | 225
HEALTH POLICY AND ETHICS

oxycodone compared with controlled- 23. Tough P. The alchemy of OxyContin: antidepressants in postherpetic neuralgia. 47. ‘‘Partners Against Pain’’ Web site,
release morphine in treatment of cancer from pain relief to drug addiction. New Neurology. 2002;59:1015–1021. under ‘‘Professional Education’’ menu
pain: a randomized, double-blind, York Times Magazine. July 29, 2001:37. 34. Huse E, Larbig W, Flor H, et al. The and ‘‘Opioids and back pain: the last
parallel-group study. Eur J Pain. 1998; effect of opioids on phantom limb pain taboo’’—2000. Available at: http://
24. Moulin DE, Iezzi A, Amireh R, et al.
2:239–249. and cortical reorganization. Pain. 2001; www.partnersagainstpain.com/html/
Randomized trial of oral morphine for
9. Bruera E, Belzile M, Pituskin E, et al. 90:47–55. proofed/pmc/pe_pmc6.htm. Accessed
chronic non-cancer pain. Lancet. 1996;
Randomized, double-blind, cross-over March 19, 2001.
346:143–147. 35. Moran C. MS continuous tablets and
trial comparing safety and efficacy of oral 48. Pain Management [CD and slide in-
25. Watson CP, Babul N. Efficacy of pain control in severe rheumatoid arthri-
controlled-release oxycodone with con- structional program for physicians].
oxycodone in neuropathic pain: a ran- tis. Br J Clin Res. 1991;2:1–12.
trolled-release morphine in patients with Stamford, CN: Purdue Pharma; 2002.
cancer pain. J Clin Oncol. 1998;16: domized trial in postherpetic pain. Neu- 36. Jamison RN, Raymond SA, Slawsby
rology. 1998;50:1837–1841. 49. Dispelling the Myths About Opioids
3222–3229. EA, et al. Opioid therapy for chronic
[brochure for physicians]. Stamford, CN:
26. Caldwell JR, Rapoport RJ, Davis JC, noncancer back pain: a randomized pro-
10. ‘‘New Drug Application for OxyCon- Purdue Pharma; 1998.
et al. Efficacy and safety of a once-daily spective study. Spine. 1998;23:2591–
tin.’’ Purdue Pharma, Stamford, CN De- 50. Meier B. Pain Killer. Emmaus, PA:
morphine formulation in chronic, moder- 2600.
cember 1995. Rodale Press; 2003:99.
ate-to-severe osteoarthritis pain: results 37. Arkinstall W, Sandler A, Groghnour
11. Chou R, Clark E, Helfand M. Com- 51. Porter J, Jick H. Addiction rare in
from a randomized, placebo-controlled, B, et al. Efficacy of controlled-release
parative efficacy and safety of long-acting patients treated with narcotics. N Engl J
double-blind trial and an open-label ex- codeine in chronic non-malignant pain: a
oral opioids for chronic non-cancer pain. J Med. 1980;302:123.
tension trial. J Pain Symptom Manage. randomized placebo-controlled trial. Pain.
Pain Symptom Manage. 2003;26(5):
2002;23:178–291. 1995;62:168–178. 52. Perry S, Heidrich G. Management of
1026–1048.
27. Gimbel J, Richards P, Portenoy R. 38. Sheather-Reid RB, Cohen ML. Effi- pain during debridement: a survey of US
12. ‘‘OxyContin Marketing Plan, 1996.’’ burn units. Pain. 1982;13:267–280.
Controlled-release oxycodone for pain in cacy of analgesics in chronic pain: a series
Purdue Pharma, Stamford, CN.
diabetic neuropathy: a randomized con- of N-of-1 studies. J Pain Symptom Manage. 53. Fishbain DA, Rosomoff HL, Rosomoff
13. ‘‘OxyContin Marketing Plan, 1997.’’ trolled trial. Neurology. 2003;60:927– 1998;15:244–252. RS. Drug abuse, dependence, and addic-
Purdue Pharma, Stamford, CN. 934. tion in chronic pain patients. Clin J Pain.
39. Martell BA, O’Connor PG, Kerns RD,
14. ‘‘OxyContin Marketing Plan, 1998.’’ 28. Peloso P, Bellamy N, Bensen W, et al. et al. Systematic review: opioid treatment 1992;8:77–85.
Purdue Pharma, Stamford, CN. Double blind randomized placebo con- for chronic back pain: prevalence, effi- 54. Hoffmann NG, Olofsson S, Salen B,
15. ‘‘OxyContin Marketing Plan, 1999.’’ trolled trial of controlled release codeine cacy, and association with addiction. Ann Wickstrom L. Prevalence of abuse and
Purdue Pharma, Stamford, CN. in the treatment of osteoarthritis of the Intern Med. 2007;146:116–127. dependence in chronic pain patients. Int J
16. ‘‘OxyContin Marketing Plan, 1996.’’ hip or knee. J Rheumatol. 2000;27: 40. Ballantyne JC. Opioids for chronic Addict. 1995;30:919–927.
Purdue Pharma, Stamford, CN. 764–771. nonterminal pain. South Med J. 2006;99: 55. Kouyanou K, Pither CE, Wessely S.
29. Roth SH, Fleischmann RM, Burch FX, 1245–1255. Medication misuse, abuse, and chronic
17. ‘‘OxyContin Marketing Plan, 2001.’’
Purdue Pharma, Stamford, CN. et al. Around-the-clock controlled-release 41. Regier DA, Myers JK, Kramer M, et al. dependence in chronic pain patients. J
oxycodone therapy for osteoarthritis-re- The NIMH epidemiological catchment Psychosom Res. 1997;43:497–504.
18. ‘‘OxyContin: balancing risks and
lated pain. Arch Intern Med. area program. Historical context, major 56. Chabal C, Erjaved MK, Jacobson L,
benefits,’’ in Hearing of the Committee on
2000;160:853–860. objectives, and study population charac- et al. Prescription opiate abuse in chronic
Health, Education, Labor, and Pensions,
teristics. Arch Gen Psychiatry. pain patients: clinical criteria, incidence,
United States Senate, February 12, 2002, 30. Caldwell JR, Hale ME, Boyd RE, et al.
1984;41:934–941. and predictors. Clin J Pain. 13;150–155.
p 87 (testimony of Paul Goldenheim, Treatment of osteoarthritis pain with
Purdue Pharma). controlled release oxycodone or fixed 42. Katz N. Opioids: after thousands of 57. Katz NP, Sherburne S, Beach M, et al.
combination oxycodone plus acetamino- years, still getting to know you. Clin J Pain. Behavioral monitoring and urine toxicol-
19. Prescription Drugs: OxyContin Abuse
phen added to nonsteroidal anti-inflam- 2007;23:303–306. ogy testing in patients receiving long-term
and Diversion and Efforts to Address the
matory drugs: a double blind, random- 43. Irick N, Lipman A, Gitlin M. Over- opioid therapy. Anesth Analg.
Problem. Washington, DC: General Ac-
ized, multicenter, placebo controlled trial. coming Barriers to Effective Pain Manage- 2003;97:1097–1102.
counting Office; December 2003. Publi-
J Rheumatol. 1999;26:862–869. ment [audiotape]. Rochester, NY: Solu-
cation GAO-04-110. 58. Reid M, Engles-Horton L, Weber M,
31. Rowbotham MD, Twilling LO, Davies tions Unlimited; March 2000. et al. Use of opioid medications for
20. Orlowski JP, Wateska L. The effect of
pharmaceutical firm enticements on phy- PS, et al. Oral opioid therapy for chronic 44. Carr B, Kulich R, Sukiennik A, et al chronic non-cancer pain. J Gen Intern Med.
sician prescribing patterns. There’s no peripheral and central neuropathic pain. The Impact of Chronic Pain—An Interdis- 2002;17:173–179.
such thing as a free lunch. Chest. 1992; N Engl J Med. 2003;348: ciplinary Perspective. Continuing Medical 59. Michna E, Jamison RN, Pham LD,
102:270–273. 1223–1232. Education program. New York, NY: et al. Urine toxicology screening among
32. Kjaersgaard-Andersen P, Nafei A, Power-Pak Communications; 2000:925. chronic pain patients on opioid therapy:
21. Stolberg SG, Gerth J. High-tech stealth
Skov O, et al. Codeine plus paracetamol Program 424-000-99-010-H01. frequency and predictability of abnormal
being used to sway doctor prescriptions.
New York Times. November 16, 2000. versus paracetamol in longer-term treat- 45. Lipman A, Jackson K II. Use of Opioids findings. Clin J Pain. 2007;23:173–179.
Available at: http://query. ment of chronic pain due to osteoarthritis in Chronic Noncancer Pain. Continuing 60. Hojsted J, Sjogren P. Addiction to
nytimes.com/gst/fullpage.html?res= of the hip: a randomized, double-blind Medical Education program. New York, opioids in chronic pain patients: a litera-
9502EEDF153BF935A25752C1A9669 multi-centre study. Pain. 1990;43:309– NY: Power-Pak Communications; April ture review. Eur J Pain. 2007;11:490–
C8B63&sec=&spon=&pagewanted=1. 318. 2000:6. 518.
Accessed September 11, 2008. 33. Raja SN, Haythornthwaite JA, 46. How You Can Be a Partner Against 61. United States Attorney’s Office West-
22. Adams C. Painkiller’s sales far Pappagallo M, et al. A placebo-controlled Pain and Gain Control Over Your Own ern District of Virginia [news release].
exceeded levels anticipated by maker. trial comparing the analgesic and cogni- Pain [patient brochure]. Stamford, CN: Available at: http://www.dodig.osd.mil/
Wall Street Journal. May 16, 2002. tive effects of opioids and tricyclic Purdue Pharma; 1998. IGInformation/IGInformationReleases/

226 | Health Policy and Ethics | Peer Reviewed | Van Zee American Journal of Public Health | February 2009, Vol 99, No. 2
HEALTH POLICY AND ETHICS

prudue_frederick_1.pdf. Accessed 2006 National Survey on Drug Use and


September 11, 2008. Health. Available at: http://www.oas.
samhsa.gov/nsduh/2k6nsduh/
62. United States of America v The Purdue
2k6Results.pdf. Accessed March 12,
Frederick Company Inc et al., (WD Va, May
2008.
10, 2007), Case 1:07CR00029.
74. Paulozzi LJ, Budnitz DS, Yongli X.
63. Rischitelli DG, Karbowicz SH. Safety
Increasing deaths from opioid analgesics
and efficacy of controlled-release oxyco-
in the United States. Pharmacoepidemiol
done: a systematic literature review.
Drug Saf. 2006;15:618–627.
Pharmacotherapy. 2002;22:898–904.
75. Pulse Check: Trends in Drub Abuse.
64. Drug Enforcement Administration,
Washington, DC: Office of National Drug
Office of Diversion Control. Action plan
Control Policy, Executive Office of the
to prevent the diversion and abuse of
President; November 2002.
OxyContin. Available at: http://www.
deadiversion.usdoj.gov/drugs_concern/ 76. Wazana A. Physicians and the phar-
oxycodone/abuse_oxy.htm. Accessed maceutical industry: is a gift ever just a
March 12, 2008. gift? JAMA. 2000;283:373–380.

65. Crews JC, Denson DD. Recovery of 77. Grande D. Prescribing profiling: time
morphine from a controlled-release to call it quits. Ann Intern Med. 2007;
preparation: a source of opioid abuse. 146:751–752.
Cancer. 1990;66:2642–2644. 78. Compton W, Volkow N. Major in-
66. ‘‘New Drug Application to FDA for creases in opioid analgesic abuse in the
OxyContin, Pharmacology Review: United States: concerns and strategies.
‘Abuse Liability of Oxycodone.’ ’’ Purdue Drug Alcohol Depend. 2006;81:103–
Pharma, Stamford, CN, 1995. 107.

67. States of Alabama, Maine, Kentucky,


Virginia, and West Virginia Drug Profile
by County—OxyContin, Oxycodone (Ex-
cluding OxyContin), and Hydroco-
done—2000. Washington, DC: Office of
Diversion Control, Drug Enforcement
Administration; 2002.
68. OxyContin Abuse: Maine’s Newest Ep-
idemic. Augusta: Maine Office of Sub-
stance Abuse; January 2002.
69. Paulozzi LJ. Opioid analgesic in-
volvement in drug abuse deaths in
American metropolitan areas. Am J Public
Health. 2006;96:1755–1757.
70. Substance Abuse and Mental Health
Services Administration. National Survey
on Drug Use and Health. Available at:
http://www.oas.samhsa.gov/NSDUH/
2k4nsduh/2k4Results/2k4Results.pdf.
Accessed March 12, 2008.
71. Gilson AM, Ryan KM, Joranson DE,
et al. A reassessment of trends in the
medical use and abuse of opioid analge-
sics and implications for diversion control:
1997–2002. J Pain Symptom Manage.
2004;28:176–188.
72. Substance Abuse and Mental Health
Services Administration. Results from the
2005 National Survey on Drug Use and
Health: national findings. Available at:
http://www.oas.samhsa.gov/nsduh/
2k5nsduh/2k5Results.pdf. Accessed
March 12, 2008.
73. Substance Abuse and Mental Health
Services Administration. Results from the

February 2009, Vol 99, No. 2 | American Journal of Public Health Van Zee | Peer Reviewed | Health Policy and Ethics | 227

You might also like