Open access, freely available online
The Global Threat of Counterfeit Drugs:
Why Industry and Governments Must
Communicate the Dangers
☯*, Paul N. Newton
☯, E. Kyeremateng Agyarko, Dora Akunyili, Nicholas J. White
loss of public conﬁ dence in medicines
counterfeit drugs to the FDA within ﬁ ve
days of discovery (see “Companies That
rising (see “The Scale of the Problem”)
The Number of Investigations of
Possible Counterfeit Drugs by the FDA Has Been Rising
governmental and industry initiatives.
The Scale of the Problem
of all sold drugs are fake, and in parts
of Africa and Asia this ﬁ gure exceeds
Cockburn R, Newton PN, Agyarko EK,
Akunyili D, White NJ (2005) The global threat of counterfeit drugs: Why industry and governments
must communicate the dangers. PLoS Med 2: e100.
2005 Cockburn et al. This is an open-
ﬁ ercely competitive business. Publicly,
access article distributed under the terms of the
Creative Commons Attribution License, which permits
the justiﬁ cation for secrecy is to avoid
unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
FDA, US Food and Drug
Administration; GSK, GlaxoSmithKline; NAFDAC,
Nigerian National Agency for Food and Drug
Administration and Control; PSI, Pharmaceutical Security Institute; WHO, World Health Organization
it is also not in the long-term interests
Robert Cockburn is a writer and formerly a journalist
with The Times
, London, United Kingdom. Paul N. Newton is at the Centre for Clinical Vaccinology and
Tropical Medicine, Churchill Hospital, University of
Oxford, United Kingdom. E. Kyeremateng Agyarko is
little scientiﬁ c public health enquiry
Chief Executive of the Food and Drug Board, Accra, Ghana. Dora Akunyili is Director-General of the
National Agency for Food and Drug Administration
and Control, Lagos, Nigeria. Nicholas J. White is at the Faculty of Tropical Medicine, Mahidol University,
Bangkok, Thailand, and the Centre for Clinical
which has a serious conﬂ ict of interest.
Vaccinology and Tropical Medicine, Churchill Hospital,
NJW is on the editorial board
patients killed by fake drugs in China in
of PLoS Medicine
. RC, PNN, EKA, and DA declare that
2001 gives an indication of the scale of
*To whom correspondence should be addressed. E-mail: [email protected]
The Policy Forum allows health policy makers around
Secrecy and Counterfeit Medicines
the world to discuss challenges and opportunities for
☯These authors contributed equally to this work
improving health care in their societies.
inception, it was recognized that a great
of Counterfeit Drugs
• Approximately one-third to one-half of
down of counterfeit industries, but this
packets of artesunate tablets, the pivotal,
life-saving anti-malarial drug, recently
a locality. It is obviously correct that
inexpensive “artesunate” tablets only to
ﬁ nd that they were counterfeit [7,39]. See
Figure 2 for examples of fake artesunate
being sold in mainland Southeast Asia.
• A total of 192,000 Chinese patients are
authorities “closed 1,300 factories while
investigating 480,000 cases of counterfeit
the companies’ policies on what action
the drug supply in their country. This is
reﬂ ected in the lack of action in much
of counterfeits, relative to their large
growth hormone , ﬁ lgrastim [33,41],
notiﬁ ed that one of their products was
• Nigeria recently threatened to ban the
supplier, because of the high prevalence
Paucity of Warnings about
of counterfeits amongst the imports .
• In Haiti, Nigeria, Bangladesh, India,
involvement in the false certiﬁ cation
Paciﬁ c region, an area severely affected
found to be counterfeit, with no traces of
“It is difﬁ cult to declare a [fake drug]
inoculated with the fake vaccines .
Pharmaceutical Industry Survey
in central Africa  raises the prospect
Society of Great Britain] is not issuing
of a disastrous setback in the treatment
has recently revised its position. David
us (E-mail letter, 14 February 2005), “If
then it is vital that they are informed.
involved” . A recent review of the
information” . At the International
added, “It is important that news stories
“the drugs industry had a great deal of
Information Strictly Conﬁ dential
a loss of conﬁ dence in the products…
been “very difﬁ cult to obtain citable
meeting sales’ targets is such that you
have strictly conﬁ dential” . In 1989,
between different operating divisions of
inhalers. London’s The Times
authorities, but more importantly still,
all 14,000 pharmacists in Britain ﬁ ve
the discovery of oral contraceptive pills made of wheat ﬂ our for 30 days while they carried out their own investigation . According to the Far Eastern Economic Review
, the company was ﬁ ned US$2.5 million by the Brazilian government . Schering do Brasil informed us (E-mail letter, 17 February 2005) that “Federal Justice cancelled the ﬁ ne in 2002 after the company appealed”. In Niger, in 1995, one of the fake meningitis vaccines originating from Nigeria was labelled as made by
SmithKline Beecham, but Le Monde
reported that the company did not act
Genuine and Fake Guilin Pharma Artesunate Blister Pack Holograms Found in Mainland
against the counterfeiters, afraid that it
Southeast Asia (A) is the genuine hologram attached to the blister packs of the genuine Guilin Pharma
artesunate. The red arrow points to a legend stating “GUILIN PHARMA”, which is visible with the naked eye as a thin strip below the waves, but can only be read with a
Fake Paediatric Anti-Malarial
microscope (letters are about 0.1 mm high).
(B) is a fake artesunate blister pack hologram: the upper red ring shows that the hologram has crescents, rather than a continuous blank line, between mountain and
waves, and the lower ring shows that there is no “GUILIN PHARMA” legend.
(C) is also a fake artesunate blister pack hologram: the red ring shows that the “GUILIN
PHARMA” legend is present but the letters are of larger font than those on the genuine
hologram and can be read with the naked eye (letters are about 0.3 mm high).
A warning sheet giving more details and photographs is available in . (Photos: Paul Newton, Wellcome Trust SE Asian Tropical Medicine Research Units)
public warning on fake Halfan.” GSK’s
Box 1. The Pharmaceutical
The PSI is a not-for-proﬁ t corporation
to collate their fake drug information to
cooperate in ﬁ ghting the racket. Based
in Vienna, Virginia, United States, the PSI
details of preparation type or location,
wider illegal trade in fake Halfan syrup
identiﬁ ed in West Africa, and GSK’s
inc.org) states, “On a daily basis, many
serious injury to their health by taking
health authorities, or the public. Such is
distribution and the scale of the racket
the secrecy of the PSI’s information, that
only that “counterfeit Halfan is present
Companies That Have Warned
alerted GSK’s Ghana agent, who visited
Halfan syrup’s identifying details. The
will still issue a warning even if we ﬁ nd
it in only one shop. If you ﬁ nd any fake
fakes by the authorities in Ghana”.
be sure it is in many villages…We don’t
Radio 4, “File on 4”, 5 October 2004)
Other companies, at least initially, did
their own ﬁ nancial gain . In 2002,
of counterfeit adult Halfan caplets from
being notiﬁ ed of a severe counterfeit
reasonable steps to warn the public of a
Drug Companies Sued in the US
that information should be veriﬁ ed and
publicized the discovery of fakes of its
conﬂ ict of interest. We believe that the
long-term interests of both the industry
fakes of Neupogen (ﬁ lgrastim) .
in April 2003 that, from 1 May 2003, its
to the FDA “within ﬁ ve working days of
become a global standard. Indeed, we have not found one country where
Enforce a Legal
their products to public health or trade
The Sharing of Information
on Counterfeit Medicines
A collection of counterfeit pharmaceutical drugs seized by
the NAFDAC in Nigeria
(Photograph: NAFDAC/International Chamber of
Commerce Counterfeiting Intelligence Bureau)
We are very grateful to Dr. Lembit Rago,
Department; Dr. Allan Schapira, WHO Roll
Chairman of the Global Anti-Counterfeiting
Group; Mark Morris, Kansas City Star
Erik Madsen, Interpol; Danièle Letoré,
Genevensis; and Marie Ose, Agence France Presse. We are very grateful to Professor
Pharmaceutical Board of Sierra Leone, for their support for the arguments put forward
International Convention against
in this article. PN and NJW are supported by
All authors researched
PNN wrote the ﬁ rst draft, and all authors contributed to writing the ﬁ nal version of
1. Cockburn R (2002) Crime, fear and silence:
Poster Advertising the Second Global
Making public the fake pharmaceutical drug
racket [presentation]. First Global Forum
on Pharmaceutical Anticounterfeiting; 2002
September 22–25; Geneva, Switzerland.
2. (2003 November 11) Global rise in use of
http:⁄⁄news.bbc.co.uk/go/em/fr/-/2/hi/health/3261385.stm. Accessed 17 November
3. World Health Organization (1992) Counterfeit
1992. WHO/DMP/CFD/92. Geneva: World Health Organization. 26 p.
Aviation Industry Model
4. World Health Organization (1998) Report of
police action against the counterfeiters
the International Workshop on Counterfeit Drugs. WHO/DRS/CFD/98.1. Geneva: World
5. Newton PN, Rozendaal J, Green M, White
NJ (2002) Murder by fake drugs—Time for
international action. BMJ 324: 800–801.
of a counterfeit drug is conﬁ rmed, the
6. Saywell T, McManus J (2002 February 21)
What’s in that pill? Far East Econ Rev: 34–40.
7. Newton PN, Proux S, Green M, Smithuis F,
Rozendaal J, et al. (2001) Fake artesunate in
southeast Asia. Lancet 357: 1948–1950.
delayed over fake asthma inhalers. The Times
information, to facilitate the protection
9. (2001 September 4–10) Bad medicine. Tempo
10. Crampton T (2003 August 25) Fake malaria
countries that may be affected, with the
pills haunt Asians. International Herald
assistance of Interpol as required. If a
11. Chakravarty S, Unnithan S, Ram A (2001
drug regulatory authority is conﬁ dent,
January 29) Deadly doses. India Today: 58–61.
Counterfeit Drug Conference
12. Fackler M (2002 July 29) China’s fake drugs kill
13. Cockburn R (1982 December 10) Counterfeit
drugs—The other killer in Lebanon. The
14. Cockburn R (1984 June 29) Counterfeit
drugs that are kill rather than cure. Guardian
15. World Health Organization (2001) Counterfeit
drug reports: 1999—October 2000 [table].
trail of information so that it is clear
pnewslet/pn300cfd.html. Accessed 17 June
16. Rago L (2002) Counterfeit drugs: Threat to
organizations, and private investigators
public health [presentation]. First Global
Forum on Pharmaceutical Anticounterfeiting; 2002 September 22–25; Geneva, Switzerland.
17. Gibson L (2004) Drug regulators study global
treaty to tackle counterfeit drugs. BMJ 328: 486.
18. (2003 October 1) Lok Ayukta indicts former
Notice number 19. London: UK Civil Aviation
Karnataka DC and two senior ofﬁ cials,
electrospray ionisation mass spectrometry,
Authority. Available: http:⁄⁄www.caa.co.uk/
recommend dismissal from service. Mumbai
accurate mass tandem mass spectrometry and
docs/33/CAP455.PDF. Accessed 10 November
liquid chromatography/mass spectrometry.
19. (1989 November 29) More UK debate on
Rapid Comm Mass Spectrom 17: 215–221.
39. Dondorp AM, Newton PN, Mayxay M, Van
28. Nigerian National Agency for Food and Drug
Damme W, Smithuis FM, et al. (2004) Fake
20. World Health Organization Department
Administration and Control (2002 June) List of
antimalarials in Southeast Asia are a major
identiﬁ ed fake products [June 2002]. NAFDAC
impediment to malaria control: Multinational
(1999) Counterfeit drugs: Guidelines for
ref 20-12. Abuja (Nigeria): Nigerian National
cross-sectional survey on the prevalence of
Agency for Food and Drug Administration and
fake antimalarials. Trop Med Int Health 9:
Organization. Available: http:⁄⁄whqlibdoc.
29. (2003 April 7) GlaxoSmithKline case study.
40. Yardley J (2004 May 5) Infants in Chinese city
Judicial Protection of IPR in China. Available:
starve on protein-short formula. New York
21. Moken MC (2003) Fake pharmaceuticals: How
news14.htm. Accessed 22 February 2005.
they and relevant legislation or lack thereof
30. Dunea G (1983) Death over the counter. BMJ
Counterfeit drugs. N Engl J Med 350: 1384–
contribute to consistently high and increasing
drug prices. Am J Law Med 29: 525–542.
31. Schwab D (2003 September 21) Protecting
42. Raufu A (2003) India agrees to help Nigeria
Procrit. Sunday Star-Ledger: 1, 8, 9.
tackle the import of fake drugs. BMJ 326:
32. James JS (2001 May 31) Counterfeit drugs:
43. (1995) Fake drugs: A scourge of the system.
23. Csillag C (1998) Epidemic of counterfeit drugs
Treat News; issue 380. Available: http:⁄⁄www.
causes concern in Brazil. Lancet 352: 553.
44. Hanif M, Mobarak MR, Ronan A, Rahman
24. Broussard P (1996 October 26) Du Nigeria au
D, Donovan J, et al. (1995) Fatal renal failure
Niger, d’étranges vaccins contre la méningite.
33. Charatan F (2001) Fake prescription drugs are
caused by diethylene glycol in paracetamol
ﬂ ooding the United States. BMJ 322: 1443.
exlixir: The Bangladesh epidemic. BMJ 311:
25. Hay SI, Guerra CA, Tatem AJ, Noor AM,
34. US Food and Drug Administration (2003
Snow RW (2004) The global distribution and
45. O’Brien KL, Selanikio JD, Hecdivert C,
population at risk of malaria: Past, present, and
Placide MF, Louis M, et al. (1998) Epidemic
future. Lancet Infect Dis 4: 327–336.
of pediatric deaths from acute renal failure
26. Chryss J, producer (2004) Transcript of “File
caused by diethylene glycol poisoning. JAMA
on 4”: Counterfeit drugs [transcript of radio
35. (2003) Who will take responsibility for
46. Ahmad K (2004) Antidepressants are sold as
London: British Broadcasting Corporation.
corporate killing? Lancet 361: 1921.
antiretrovirals in DR Congo. Lancet 363: 713.
36. Morris M (2002 December 6) Pharmacist gets
47. (2005 January) Warning: At least seven
30 years for diluting medicines. Kansas City
types of fake artesunate are being sold in
counterfeitdrugs.pdf. Accessed 9 February
mainland SE Asia. Wellcome Trust SE Asian
37. Margolies D (2003 February 9) Payments set for
Tropical Medicine Research Units. Available:
27. Wolff JC, Thomson LA, Eckers C (2003)
Courtney victims. Kansas City Star; Sect A: 1.
Identiﬁ cation of the ‘wrong’ active
38. UK Civil Aviation Authority (2001 October 29)
pharmaceutical ingredient in a counterfeit
The problem of bogus parts. Airworthiness
0 ENR 5-3-15 CONDITIONS DE SURVOL DES RÉGIONS INHOSPITALIÈRES ET DE L'EAU PAR LES AÉRONEFS DE TOURISME ET DE TRAVAIL AÉRIEN CONDITIONS OF FLIGHT OVER INHOSPITABLE REGIONS AND WATER SURFACE BY TOURISM AND AERIAL WORK AIRCRAFT Les présentes dispositions s'appliquent aux aéronefs de tourisme et The present arrangements are applied to tourism and aerial work de travail aérien d
Adhesion prevention in gynecologic surgeryTogas Tulandi and Abdulaziz Al-ShahraniThe purpose of this review is to discuss new substancesOne of the complications of abdominal surgery is intra-and techniques to prevent post-surgical adhesionabdominal adhesion formation. These adhesions cancause bowel obstruction and pain, whereas adnexaladhesions can cause infertility In an attempt toIntraper