Business Horizons (2013) 56, 189—197
Available online at www.sciencedirect.com
www.elsevier.com/locate/bushor
The challenge of curbing counterfeit prescription
drug growth: Preventing the perfect storm
Peggy E. Chaudhry *, Stephen A. Stumpf
Villanova School of Business, Villanova University, 800 Lancaster Avenue, Villanova, PA 19085, U.S.A.
1
KEYWORDS Abstract The recent case of fake Avastin brought the problem of counterfeit
Counterfeit pharmaceuticals to the forefront of illicit trade. Drug counterfeiters are opportunistic
pharmaceuticals; criminals motivated by the windfall profits that are realized from selling fake
Intellectual property; pharmaceuticals with limited legal penalties. This article describes the interrelated
Illicit trade; trends that may trigger a catastrophic situation of counterfeit drugs infiltrating the
Internet pharmacy; global pharmaceutical supply chain–—a ‘perfect storm.’ We discuss the failure of
Anti-counterfeiting policymakers to note the early warning signs and the ease of penetrating the
strategy pharmaceutical supply chain–—both physically and virtually–—by an array of illicit
traders, ranging from small cottage operations to full-scale manufacturing facilities;
the recent U.S. legislation enacted to curb growth in counterfeit pharmaceuticals;
and the proliferation of national, multilateral, and industry-led agencies to protect
the prescription drug supply chain. Finally, we conclude with an analysis of anti-
counterfeiting tactics (e.g., consumer education campaigns, authentication technol-
ogy) developed by various stakeholders.
# 2012 Kelley School of Business, Indiana University. Published by Elsevier Inc. All
rights reserved.
1. Predicting the size of the storm: immune to [counterfeit drugs]’’ (Weaver & Whalen,
2012). The World Health Organization (2012) defines
An elusive task
counterfeit pharmaceuticals as ‘‘medicines that are
deliberately and fraudulently mislabeled with re-
Ronald Noble, secretary-general of INTERPOL (inter-
spect to identity and/or source.’’ Almost 15 years
national police organization), stated: ‘‘The Avastin
ago, in his book, Bitter Pills: Inside the Hazardous
case was a watershed moment for law enforcement
World of Legal Drugs, Stephen Fried (1998) estimated
to recognize that this is not a problem restricted to
that 10% of the world drug supply was counterfeit. In
one part of the world. . . .It let the U.S. know it’s not
a report published by the U.S. Customs and Border
Protection, the domestic value of counterfeit drug
seizures in 2011 was $16.68 million, an increase of
* Corresponding author
200% from 2010 to 2011 (CBP Office of International
E-mail addresses: [email protected]
Trade, n.d.). The top three source countries based on
(P.E. Chaudhry), [email protected] (S.A. Stumpf)
0007-6813/$ — see front matter # 2012 Kelley School of Business, Indiana University. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.bushor.2012.11.003
190 P.E. Chaudhry, S.A. Stumpf
Figure 1. Pharmaceutical crime incidents - Regions of 2. Early warning signs of a storm
the world
brewing were marginalized
Africa 64
Katherine Eban’s (2005) provocative reporting in
Near East 128
her book, Dangerous Doses, attempted to raise
N. America 237
awareness surrounding the ease of unscrupulous
Eurasia 257 counterfeiters entering this market. One year later,
Moise´s Naim (2006) discussed an array of illicit trade
Europe 351
in various sectors, including fake pharmaceuticals,
La n America 381
in Illicit: How Smugglers, Traffickers, and Copycats
Asia 954
are Hijacking the Global Economy. In 2009, our work
Source: Adapted from the Pharmaceu cal Security Ins tute (2012) on consumer complicity to obtain illicit pharma-
ceuticals in Brazil, Russia, India, China, and the
United States was reported in The Wall Street
Journal such that business managers might better
the domestic value and volume of counterfeit goods
understand why consumers seek them (Chaudhry &
seized in 2011 were China (62%), Hong Kong (18%),
Stumpf, 2009). Roger Bate (2012) raises the health
and India (3%) (CBP Office of International Trade,
issue in his book, Phake: The Deadly World of
n.d.). Since U.S. Customs searches a very small per-
Falsified and Substandard Medicines, focusing on
centage of all products entering the United States,
the illicit trade in Africa, India, China, and the
this data significantly underestimates the problem
Middle East.
1
(Chaudhry & Zimmerman, 2009).
Extensive media coverage of fake Avastin , a
As illustrated in Figure 1, the Pharmaceutical Se-
drug used in the treatment of cancer, was breaking
curity Institute (2012) provides insight regarding the
news in 2012. In The Wall Street Journal, Jeanne
number of pharmaceutical crime incidents by region,
Whalen (2012) initially reported the fake pharma-
yet recognizes the fact that many counterfeit med-
ceutical in the U.S. supply chain as allegedly coming
ications remain undetected in the legitimate supply
from an Egyptian supplier. Just one month later,
chain. Importantly, use of counterfeit pharmaceuti-
Weaver, Whalen, and Faucon (2012) claimed that
1
cals can kill. The think tank, International Policy
Avastin was distributed through online Canadian
Network, estimated that 700,000 annual deaths
pharmacies, with an overall trade route that:
can be attributed to counterfeit drugs to treat or
prevent malaria and tuberculosis (Harris, Stevens, & [I]llustrated the circuitous path that pharma-
Morris, 2009). ceuticals can take before reaching consumers.
In April 2012, Ron Guido, Vice President of Global Wherever the counterfeit Avastin was manufac-
Brand Protection at Johnson & Johnson, in his pre- tured–—possibly China–—investigators are exam-
sentation at the International Quality and Productiv- ining a zigzagging route that may have taken
ity Center (IQPC) conference, summarized that the product through Turkey and Egypt before it
counterfeiting and diversion of pharmaceuticals is was sold to Swiss and Danish wholesalers and
a result of many factors including: free trade agree- then to Mr. Haughton’s [a Canadian citizen] UK
ments; growth and capitalization of emerging mar- wholesaler, River East Supplies Ltd.
1
kets; Asia becoming the ‘world’s factory’; the
Finally, in July 2012, the ‘path of fake Avastin ’ was
Internet, due to lack of regulations and knowledge
highlighted by Weaver and Whalen (2012) in The
of supply; illicit traders who are well-funded and
Wall Street Journal as an interactive learning tool,
technologically advanced, and who have a high re-
to better help readers comprehend the global dis-
ward-to-risk ratio; under-resourced regulatory and
tribution channel. While it is difficult to know the
enforcement agencies; lack of protection for intel-
full extent of the problem, reports on counterfeit
lectual property (IP) in some countries; liberal legis-
drugs increase dramatically every year; Table 1
lation governing cross-border trade; and lack of
illustrates a few recent cases.
control and visibility of supply chain activities (Guido,
2012). In the upcoming sections, our discussion cen-
ters on the ease of penetrating the pharmaceutical 3. Major stakeholders in the tempest
supply chain by an array of illicit traders, ranging
from small cottage operations to full-scale To better understand the actors in the U.S. pharma-
manufacturing facilities and fake online pharmacies, ceutical marketplace, we now present a succinct
and the recent proliferation of agencies and U.S. description of the market served by both manufac-
legislation designed to curb the problem. turers and wholesalers, including a discussion of
The challenge of curbing counterfeit prescription drug growth: Preventing the perfect storm 191
Table 1. Recent examples of counterfeit pharmaceuticals
SFFC medicine Country/Year Report
Avastin (cancer treatment) United States of Affected 19 medical practices in the U.S.A. The drug
America, 2012 lacked active ingredient.
Viagra and Cialis United Kingdom, 2012 Smuggled into the UK. Contained undeclared active
(erectile dysfunction) ingredients with possible serious health risks to the
consumer.
Truvada and Viread United Kingdom, 2011 Seized before reaching patients. Diverted authentic
(HIV/AIDS) product in falsified packaging.
Zidolam-N (HIV/AIDS) Kenya, 2011 Nearly 3,000 patients affected by falsified batch of
their antiretroviral therapy
Alli (weight-loss) United States of Smuggled into the U.S.A. Contained undeclared active
America, 2010 ingredients with possible serious health risks to the
consumer.
Anti-diabetic traditional China, 2009 Contained six times the normal dose of glibenclamide.
medicine (to lower Tw o people died, nine people were hospitalized.
blood sugar)
Metakelfin (antimalarial) United Republic of Discovered in 40 pharmacies. The drug lacked
Tanzania, 2009 sufficient active ingredient.
Source: World Health Organization (2012)
illicit traders and how they supply fake pharmaceuti- Several of these threats are interrelated to the
cals–—especially by way of rogue online pharmacies. continued growth of counterfeit trade, such as in-
ability to track products.
3.1. The legitimate manufacturers
3.2. The market dominance of three big
In its annual report on the U.S. pharmaceutical wholesalers
industry, Datamonitor (2011) estimated revenues
Fein (2011) illustrated the market dominance of
in this sector at $265.7 billion in 2010, with market
three companies controlling 85% of the U.S. whole-
growth of 5.5% for the 2010-2015 time frame to
sale pharmaceutical market in 2010, with almost
$346.7 billion. Four firms control almost 30% of
$300 billion in annual revenue shared between
the U.S. marketplace: Pfizer (10.9%), Merck & Co.
AmerisourceBergen Corporation ($80.7 billion); Car-
(6.1%), GlaxoSmithKline PLC (5.7%), and Johnson &
dinal Health, Inc. ($97.4 billion); and McKesson
Johnson (4.7%). Concurrently, 72.5% of the market is
Corporation ($113.5 billion). The remaining 15% of
served by other manufacturers. Lennard and Matlis
the market is fragmented by a variety of smaller
(2011) summarize the six principal threat concerns
players, such as Morris & Dickson ($3.7 billion) and
of pharmaceutical industry professionals regarding
H.D. Smith ($3.4 billion). Overall, there are hun-
their supply chain as:
dreds of secondary wholesalers and re-packagers
that can handle prescription drugs before the prod-
1. Contaminated/non-conforming raw materials
(61%); uct reaches the consumer’s mailbox or retail phar-
macy. These extra layers in the distribution network
create a porous system which limits visibility, leav-
2. Impact on product safety, efficacy, and effective-
ing opportunities for counterfeit drugs to enter the
ness (51%);
supply chain (Health Strategies Consultancy LLC,
2005). Eban’s (2005) reporting in Dangerous Doses
3. Our product being counterfeited (44%);
clearly illustrates illicit traders infiltrating the ‘Big
Three’ U.S. wholesalers and other distribution chan-
4. Lack of ability to trace products (43%);
nels with their lower prices. Of the U.S. supply
chain, the journalist said (Eban, 2005, p. 130):
5. Cost of complying with additional regulatory
burdens (42%); and Everybody bought from everybody. The biggest,
most established wholesalers, including Cardi-
6. Our product being diverted (35%). nal and Amerisource, vetted their vendors in
192 P.E. Chaudhry, S.A. Stumpf
advance. After that, price was the guiding payment facilitators (e.g., American Express,
criterion–—the lower, the better. Once suspect Discover, PayPal), search engines (e.g., Google,
medicine entered the Big Three’s warehouses, Yahoo!), and domain name registrars (e.g., Go Dad-
it became intermingled with–—and inseparable dy). The NABP is also currently working on securing a
from–—medicine purchased directly from man- top-level domain name, dot.pharmacy, for use in
ufacturers. identifying genuine online pharmacies.
3.3. The virtual sea of fake online
3.4. Illicit suppliers range from cottage
pharmacies
industries to full-scale manufacturing
facilities
Various stakeholders have described the purchase of
prescription drugs as a major issue fueling the
The profit potential of selling counterfeit pharma-
aforementioned ‘perfect storm.’ The distribution
ceuticals lures an array of opportunistic criminals
of fake drugs online represents a labyrinth of illicit
into the squall of the storm. In the journal Science
traders who deceive consumers about the legitima-
News, Ehrenberg (2011) estimated that a $1,000
cy of their websites and products. In July 2012,
investment in illegitimate prescription drugs can
the National Association of Boards of Pharmacy
yield a $30,000 return–—10 times the profit rate of
(NABP)–—the governing body for state agencies
trafficking heroin! Illicit pharmaceuticals dealers
that license pharmacies–—reported that 97% of the
stand to earn windfall gains due to potential sky-
10,065 online pharmacies were illegitimate. The
high profits, relatively low barriers to entry, and the
NABP describes the situation as follows (Internet
limited legal recourse that exists against engaging in
Drug Outlet Identification Program, 2012):
this dark side of counterfeit trade. Attempting to
describe these unscrupulous players is an elusive
When counterfeit medicines emerge, as they
task; it is illicit trade, and narratives of these
have repeatedly in the last year, it is difficult to
criminals must be drawn from a multitude of sources
trace their origin, the point in the supply chain
(Chaudhry & Zimmerman, 2012). For example, the
at which they were introduced, who perpetu-
array of reports on illicit traders ranges from profil-
ated the illegal transaction, and which parties
ing a person–—such as Michael Carlow, leader of a
knew about it and enabled it in any way. Be-
group that sold millions in fake drugs in Florida
cause Internet commerce transcends geograph-
(Eban, 2005)–—to profiling operations, such as full-
ical and jurisdictional borders, protecting the
scale manufacturing facilities in China (United
public health requires the coordinated efforts
Nations Office on Drugs and Crime, 2010). Michael
of multiple, international public and private
Carlow specialized in the sale of counterfeit cancer,
entities to diminish the threat that counter-
HIV, and cholesterol drugs such as Lipitor, and re-
feiters and rogue sellers pose.
ceived a 9-year sentence in 2010. The value of his
In September 2012, the Food and Drug Administra-
trafficking of just one fake version of Lipitor was
tion (FDA) launched its BeSafeRx (2012) campaign to
estimated at $43 million (LaMendola, 2010).
educate consumers about the menace of counter-
A 60 Minutes expose´ by Sanjay Gupta (2011)
feits available via fake online pharmacies. This
reports the counterfeit pharmaceutical drug trade
campaign centers on three distinct messages:
as a $75 billion annual global industry. The news
segment shows footage of a sting operation in Peru
1. Know the Risks (e.g., you could receive counter-
that led to uncovering the production of counterfeit
feit or substandard drugs);
goods in the basement of a house in Lima. This
lucrative illicit trade can be relatively uncomplicat-
2. Know the Signs (e.g., beware of deep discounts/
ed, yet may also be much more than a cottage
cheap prices); and
industry. A recent report of the United Nations
Office on Drugs and Crime (2010)–—or UNODC–—
3. Know your Online Pharmacy (provides a web link
describes the gamut these operations can run (p. 8):
for the consumer to authenticate his/her phar-
macy). The production of counterfeit pharmaceuticals
can be as simple as producing alternative pack-
In 2011, The Center for Safe Internet Pharmacies aging materials using a laser printer or as com-
(CSIP) was created to represent a dozen of the top plicated as the production of the original
Internet payment processors and e-commerce firms, product. In general, counterfeit production in
jointly working together to curtail fake drugs China appears to be more sophisticated than in
sourced online. CSIP founding members include India. In China, counterfeit drug producers are
The challenge of curbing counterfeit prescription drug growth: Preventing the perfect storm 193
1
Figure 2. Fake vs. Real Tamiflu
and importers who bring in drugs from China and
then fraudulently repackage them.’’
The overarching problem on the supply side is
that the barriers to entry for making fakes have
been lowered by the ease of buying pharmaceutical
machinery on Internet auction sites and the prolifer-
ation of printing technology that makes any unskilled
illicit trader able to duplicate pharmaceutical pack-
aging (Chaudhry & Zimmerman, 2012). Figure 2 illus-
trates how difficult it would be for a consumer to
discern between real versus fake Tamiflu simply
based on packaging. The necessary equipment and
materials to set up production for illicit drugs are just
a click away on the Web. For example, Figure 3 is a
screen shot of a recent search for a ‘pill making
machine’ at the Internet auction site Alibaba.com;
there were 913 results for this type of machinery.
Another query, ‘packaging pharmaceutical’ yielded
73,663 hits for various packaging materials, such
often chemical companies that are not licensed as blister packs from suppliers around the globe–—
to produce pharmaceuticals, or licensed com- primarily China.
panies that produce both legitimate and bogus
drugs.
4. The proliferation of agencies
In August 2012, The Wall Street Journal reported designed to stifle the storm
that over 2,000 individuals were arrested in China
for the trafficking of fake pharmaceuticals worth Patricia Van Arnum (2012), senior editor of Pharma-
$182 million (Burkitt, 2012). By contrast, the United ceutical Technology, highlights that cooperation be-
Nations Office on Drugs and Crime (2010, p. 8) tween regulatory bodies, standard-setting orga-
classifies illicit traders in India as ‘‘unlicensed man- nizations, and industry is needed to address the illicit
ufacturers who operate out of small cottage facto- trade of counterfeit pharmaceuticals and safeguard
ries, licensed manufacturers who secretly make the supply chain of ingredients. The Institute of
fake drugs alongside their legitimate products, Research Against Counterfeit Medicines (IRACM)
Figure 3. Pharmaceutical manufacturing machinery available at Alibaba.com
194 P.E. Chaudhry, S.A. Stumpf
illustrates the need for global harmonization of summary of selected agencies that are currently
legislation and sanctions that apply to the trafficking working on the problem.
of fake drugs, since courts will garner redress through In the United States, key organizations to consult
violation of the protective laws of intellectual prop- are the FDA; the Office of the Intellectual Property
erty; crime of deceit and falsification; misleading or Enforcement Coordinator (IPEC); Customs and
fallacious information and advertising; violation of Border Protection (CBP); Immigration and Customs
rules regarding dispensation; import and distribution Enforcement (ICE); the Departments of Justice,
of products without marketing authorization; and State, and Commerce; and the Agency for Interna-
illegal practice of the pharmacist profession (‘‘Track- tional Development. In fact, all of these agencies
ing and Condemning,’’ 2012). At the international represented the Counterfeit Pharmaceutical Inter-
level, several agencies–—such as the World Health Agency Working Group in a March 2011 report to the
Organization’s International Medical Product Anti- Vice-President and U.S. Congress on counterfeit
Counterfeiting Taskforce (WHO IMPACT), Interpol’s medicines. Each has its own hierarchy, with select
Medical Products Counterfeiting and Pharmaceutical alliances with one another (see Figure 5).
Crime (MPCPC), the Institute of Research Against
Counterfeit Medicines (IRACM), and the Permanent
5. U.S. legislative actions center on
Forum on International Pharmaceutical Crime–—are
addressing the problem. Other multilateral agencies, penalties and drug distribution to
such as the World Customs Organization (WCO) and diffuse the storm
World Intellectual Property Organization (WIPO), are
involved with the over-arching problem of counter- In the U.S. legislative pipeline, two proposed
feit trade in a variety of products. Figure 4 portrays a changes center on sentencing guidelines and drug
Figure 4. Agencies involved with the circumvention of counterfeit pharmaceuticals
•World Health Organization (IMPACT) •Counterfeit Pharmaceutical Inter-Agency Working Group (IPEC) •World Intellectual Property Organization •Customs and Border Protection •World Customs Organization •Immigration & Customs Enforcement •INTERPOL (MPCPC) •Food and Drug Administration (OCI) •Department of Justice, State, and Commerce •National Intellectual Property Rights Coordination Center •U.S. Postal Inspection
Multilateral National Agencies Organizations
Industry-led Groups International Agencies for Pharmaceuticals
•Pharmaceutical Security Institute •Center for Safe Internet Pharmacies •Institute of Research Against Counterfeit Medicines •National Association of Boards of Pharmacy •Permanent Forum on International Pharmaceutical Crime •Center for Medicine in the Public Interest •International Pharmaceutical Federation •Rx-360
The challenge of curbing counterfeit prescription drug growth: Preventing the perfect storm 195
Figure 5. Principal U.S. government agencies overseeing counterfeit pharmaceuticals
distribution. H.R. 3468: Counterfeit Drug Penalty 6. Recent tactics to suppress the
Enhancement Act of 2011 is a bill with the aim to
bluster of the storm
increase penalties and prison sentences for traffick-
ers of fake pharmaceuticals. Table 2 illustrates how
Various stakeholders have provided myriad recom-
this bill would amend the current sentencing guide-
mendations aimed at diffusing the storm, ranging
lines found in Section 2320(a) of title 18, United
from novel authentication technology to public ed-
States Code. H.R. 3026: Safeguarding America’s
ucation via consumer awareness campaigns. Next,
Pharmaceuticals Act of 2011 is meant to amend
we highlight some of the more recent anti-counter-
the Food, Drug, and Cosmetic Act, and improve
feiting tactics for illustrative purposes only.
the safety of the country’s drug supply. If passed,
the bill will introduce measures to track the supply
chain of the wholesale distribution of pharmaceut- 6.1. Raising consumer awareness through
icals and includes provisions that allow for the government and agency-led initiatives
destruction of counterfeit pharmaceuticals offered
for import into the United States. This bill includes The NABP website attempts to educate consumers
tracking measures–—such as standard numerical regarding how to validate real versus fake pharma-
identifiers–—for pharmaceuticals and would establish ceuticals as follows (‘‘Why Should I Be Concerned,’’
a regulatory system for various entities in the supply n.d.):
chain (e.g., drug manufacturers, re-packagers,
wholesalers) to authenticate the ‘history’ of the Packaging — Does the packaging look as though it
drug, and create a new system for licensing pharma- has been compromised?
ceutical wholesalers. The status of enacting these
bills in the U.S. Congress can be tracked at www. Labeling — Is the label on crooked? Is it different
govtrack.us than the label the prescription drug had before?
Table 2. Proposed change in sentencing guidelines for trafficking counterfeit drugs
Counterfeit Drug Penalty 18 USC 2320: Trafficking in
Enhancement Act of 2011 Counterfeit Goods or Services
(H.R. 3468)
Maximum fine for an $4 million $2 million
individual/prison term Life imprisonment or for any 10 years
terms of years
Maximum fine for $10 million $5 million
entities (e.g., company)
Repeat individual $8 million $5 million
offender/prison term Life imprisonment or for any 20 years
terms of years
Repeat entity offender $20 million $15 million
196 P.E. Chaudhry, S.A. Stumpf
Figure 6. Authentication technology designed for
tained legitimate product (see Figure 6). The man-
pharmaceutical packaging
ufacturer simply affixes a packaging label that
contains a concealed code, which the customer
can validate by way of smartphone or text message
(‘‘Counterfeit Drugs,’’ 2012).
6.3. Using authentication technology:
Empowering IP enforcement officials
In our opinion, consumer identification of real
versus fake is an elusive task (see Chaudhry &
Zimmerman, 2009, 2012). As discussed previously,
illicit pharmaceuticals traders are concentrating
their efforts on imitation and easy access to the
Pill Appearance — Are the pills cracked or chipped? printing technology that is necessary in developing
Has the pill color changed? Does it appear a shade copycat packaging. Thus, we feel that detecting
different from earlier prescriptions? fake pharmaceuticals should be further up the
supply chain, focusing especially on ports of entry
Pill Taste — Does the drug taste different? and international mail. Toward this end, the FDA
recently unveiled a new tool that will be helpful in
Side Effects — Did you experience any adverse this area: the hand-held Counterfeit Detection
effects? Device #3, or CD3. The CD3 emits light waves
and, when aimed at counterfeit drug products,
A variety of public awareness messages have recent- shows differences in color or shade as compared
ly been developed to address fake pharmaceuticals, to the authentic article. As it is easy to use,
including the CSIP ‘Be Safe. Buy Smart,’ INTERPOL relatively inexpensive ($1,000 per device), and
‘Proud to Be,’ and FDA ‘BeSafeRx’ campaigns. The completely portable, the CD3 will enable interna-
challenge lies in waiting to see if this type of edu- tional mail inspectors and customs and border
cation ultimately alters buyer behavior. Will con- protection officers at various U.S. ports of entry
sumers heed the warnings and take a closer look at to authenticate pharmaceuticals in ‘real time’
their pharmaceuticals, distributed both in physical (‘‘FDA Unveils,’’ 2012).
and virtual marketplaces?
6.2. Educating consumers via company- References
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