Plme0204_cockburn_pip.indd

Open access, freely available online
Policy Forum
The Global Threat of Counterfeit Drugs:
Why Industry and Governments Must
Communicate the Dangers
Robert Cockburn☯*, Paul N. Newton☯, E. Kyeremateng Agyarko, Dora Akunyili, Nicholas J. White
Introduction
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”) Figure 1. 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 Citation: 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.
Copyright: 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 Abbreviations: 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, Competing Interests: 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.
DOI: 10.1371/journal.pmed.0020100
inception, it was recognized that a great Recent Examples
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 Government Reluctance
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 [33], 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 [42].
Fake Drugs
• 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 [24].
Pharmaceutical Industry Survey
in central Africa [46] 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” [20]. A recent review of the information” [21]. 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” [22]. In 1989, between different operating divisions of inhalers. London’s The Times obtained authorities, but more importantly still, Commercial Motivation—
all 14,000 pharmacists in Britain fi ve “Cut-Throat Competition”
the discovery of oral contraceptive pills made of wheat fl our for 30 days while they carried out their own investigation [23]. According to the Far Eastern Economic Review, the company was fi ned US$2.5 million by the Brazilian government [6]. 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 Figure 2. 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 [47]. (Photos: Paul Newton, Wellcome Trust SE Asian Tropical Medicine Research Units) public warning on fake Halfan.” GSK’s Box 1. The Pharmaceutical
Security Institute
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 Cross-Border Threats
and Cooperation
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 [30]. 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) [33].
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 Governments Must
Enforce a Legal
Responsibility
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) Acknowledgments
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 Counterfeit Drugs
Author contributions. All authors researched
PNN wrote the fi rst draft, and all authors contributed to writing the fi nal version of References
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Source: http://counterfeiting.unicri.it/docs/The%20global%20threat%20of%20ctf%20drugs.pdf