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 (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,

Lan America 381

in Illicit: How Smugglers, Traffickers, and Copycats

Asia 954

are Hijacking the Global Economy. In 2009, our work

Source: Adapted from the Pharmaceucal Security Instute (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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