[e-drug] More transparency about counterfeits needed

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: More transparency about counterfeits needed
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[this article in PLOS (fully accessible on the Internet!) shows at the increasing problem of counterfeit pharmaceuticals. Not only in Africa, but also in the USA (see list of examples at the bottom. E-drug reproduces the abstract and a list of examples; it is worth downloading the full paper. Thanks to Andy for spotting. Copied as fair use. WB]

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020100

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

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 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 Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, United Kingdom.

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Introduction

The production of substandard and fake drugs is a vast and underreported problem, particularly affecting poorer countries. It is an important cause of unnecessary morbidity, mortality, and loss of public confidence in medicines and health structures. The prevalence of counterfeit drugs appears to be rising (see "The Scale of the Problem") and has not been opposed by close cooperation between drug companies, governments, or international organizations concerned with trade, health, customs and excise, and counterfeiting.

In this article we suggest that many pharmaceutical companies and governments are reluctant to publicize the problem to health staff and the public, apparently motivated by the belief that the publicity will harm the sales of brand-name products in a fiercely competitive business. Publicly, at least, several industry sources say the justification for secrecy is to avoid any alarm that could prevent patients taking their genuine medicines. We argue that this secrecy, and the subsequent lack of public health warnings, is harming patients and that it is also not in the long-term interests of the legitimate pharmaceutical industry. We urge a change to mandatory reporting to governmental authorities, which should also have a legal duty to investigate, issue appropriate public warnings, and share information across borders. This is not a role for the pharmaceutical industry, which has a serious conflict of interest.

While some drug companies have given public warnings to protect patients, others have been criticized for withholding information and, in a recent development in the United States, taken to court for failing to act. The industry is addressing the problem. In 2003, US pharmaceutical companies made an agreement with the US Food and Drug Administration (FDA) that they would report suspected counterfeit drugs to the FDA within five days of discovery (see "Companies That Have Warned"), although this remains a voluntary arrangement. In many poorer countries, where the problem is at its worst, there are no similar governmental and industry initiatives.

[for full text, see http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020100 ]

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Recent Examples of Counterfeit Drugs

Approximately one-third to one-half of packets of artesunate tablets, the pivotal, life-saving anti-malarial drug, recently bought in Southeast Asia were fakes, containing no active ingredient at all. A nongovernmental organization in a Southeast Asian country bought 100,000 inexpensive artesunate tablets only to find 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 reported to have died in 2001 from fake drugs, and in the same year Chinese authorities closed 1,300 factories while investigating 480,000 cases of counterfeit drugs worth 57 million USD [12]. In 2004, Chinese authorities arrested 22 manufacturers of grossly substandard infant milk powder and closed three factories after the death of over 50 infants [40].

In North America, counterfeit atorvastatin [41], erythropoietin [41], growth hormone [33], filgrastim [33,41], gemcitabine [36,37], and paclitaxel [36,37] have been reported recently.

Nigeria recently threatened to ban the import of all drugs from India, a major supplier, because of the high prevalence of counterfeits amongst the imports [42].

In Haiti, Nigeria, Bangladesh, India, and Argentina, more than 500 patients, predominantly children, are known to have died from the use of the toxin diethylene glycol in the manufacture of fake paracetamol syrup [43,44,45]. [The Haithi case was not a fake product but a toxic fake raw material which a Netherlands company exported to Haiti, where it was used in a local syrup. WB]

During the 1995 meningitis epidemic in Niger, the authorities received a donation of 88,000 Pasteur Merieux and SmithKline Beecham vaccines from neighbouring Nigeria. The drugs were found to be counterfeit, with no traces of active product. Some 60,000 people were inoculated with the fake vaccines [24].

The recent discovery of counterfeit antiretrovirals (stavudine-lamivudine-nevirapine and lamivudine-zidovudine) in central Africa [46] raises the prospect of a disastrous setback in the treatment of AIDS in sub-Saharan Africa, unless vigorous action is taken now.