The Tragedy Caused by Fake Antimalarial Drugs

Published: May 4, 2012
Received: January 19, 2012
Accepted: April 20, 2012
Mediterr J Hematol Infect Dis 2012, 4(1): e2012027, DOI 10.4084/MJHID.2012.027 This article is available from: http://www.mjhid.org/article/view/9952

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

 

Abstract. Counterfeit antimalarials (mainly artemisinin derivatives) is a crucial health problem in developing countries, particularly in Africa. The illegal production, sale and distribution of fake drugs is a huge market evaluated to several billion of dollars and represents more than 50% of the pharmaceutical market in several African countries.

Fake drugs have led to a very great number of deaths from untreated malaria or fatality provoked by toxic ingredients. These fake medicines increase the risk of artemisinin resistance developed by the use of sub therapeutic dosages of antimalarials. Tackling this criminal traffic is the objective of an international program created by WHO and involves the international police and custom organizations like INTERPOL. Several very important and encouraging results have been obtained, but the problem will be completely solved if genuine antimalarials, free-of-charge, are handed-over to populations in sub Sahara African countries.

On the whole, counterfeiting of drugs is a huge market estimated by WHO at more than US$35 billion and represents more than 15% of the pharmaceutical market worldwide with this proportion rising to more than 60% in developing countries (35-90% in south East Asia).

The counterfeit market continued to grow and has considerably spread all over the world during the last decade, particularly in developing countries very often with the most dramatic consequences. This is largely the result of the wide-spread use of the internet to market counterfeit products in an unregulated environment of anonymity. The World Health Organization (WHO) estimates that 50% of medicines available via internet are fake.

Fake drugs are easily transportable, have high value per unit, and above all, their quality cannot be scientifically or legally assessed without a quality testing laboratory.Almost all kinds of medicines are counterfeited, but antimalarials and particularly artemisinin derivatives are more vulnerable to counterfeiting.

Jupiter programme published in the open-access journal PLoS Medicine, 30 to 35% of bought artesunate are counterfeit in South East Asia (Thai-Myanmar border, Laos, Cambodia and Vietnam).11 A report was presented by Interpol to the Chinese Ministry of Health which launched a criminal investigation resulting in the arrest of a native of Yunnan province alleged to have bought 240 000 blisters of counterfeit artesunate.

There is also a thriving fake antimalarial drug industry in some African countries, where governments promote locally produced antimalarials which are not always counterfeited, stricto sensu, but sub-standard or fake drugs, with a name, label, packaging different from that of the genuine products.

Counterfeiting is more than a criminal act. Manslaughter11 is perfectly justified to describe such an act although some prefer calling it simply murder. It always involves unscrupulous people directing a highly organized technical and sophisticated criminal

trade.

The full extent of this deceptive yet lucrative criminal activity is not well known. Figures are underestimated and the consequences of this criminal activity certainly go beyond human boundaries.8 Fake drugs have led to a very great number of deaths (unfortunately impossible to know how many even by estimates or even to evaluate) from untreated malaria or provoked by toxic ingredients as these fake medicines increase the risk of artemisinin resistance as a result of the use of sub therapeutic dosages of antimalarials.

The traffic of fake antimalarials is evidently linked to the dramatic widespread prevalence of malaria in many countries and the need for an affordable and active treatment. But officials of non-governmental organizations (NGO’s), international agencies or aid organizations, through support of the Global Fund have initiated some incentives. They want to increase competition and lower the prices of medicines but they rarely take note of the counterfeit market these incentives can encourage. After an active information campaign during the past years, some of the associations and agencies are more careful; but the problem still exists with small NGOs who have scant experience of the health and economic realities in developingcountries.

Indeed, identical holograms, batch numbers and expiry dates, and blisters and tablets looking absolutely genuine, make detection of fake drugs particularly difficult. Their packaging is always a perfect copy and their quality cannot be assessed readily by lay persons or even experts of pharmaceutical industry without the aid of a quality testing laboratory. To check the product(s) inside the blisters, many techniques were proposed, the most precise being of course the most sophisticated (for example, the innovative high-performance liquid chromatography method, two-dimensional diffusion- ordered nuclear magnetic resonance spectroscopy, combined to imaging desorption electrospray ionization mass spectrometry, and direct analysis in real-time mass spectrometry).6,15,16 These obviously require laboratories with high level of technical facilities which are rarely available in developing countries.

Fake drugs detection is only the first step. In almost all cases, it is after all impossible to identify the manufacturers except in exceptional situations as was the case in China, where a rare pollen specific in an area was detected by palynology18 in fake artemisinins and allowed the authorities to arrest those involved in this criminal activity. Very often even when the brain behind this lucrative business is identified, it is generally impossible to arrest him before he slips away.

Last year, 45 countries took part in an internet-based campaign (operation PANGEA III) involving several international organizations, including police, customs, national drug regulators and internet service providers.

Although the internet plays a major role in this traffic, it is not the only mean used by wholesalers. To tackle drugs counterfeiting other solutions have to be adopted in developing countries, mainly in Africa, at the multinational or national level. Some notable success were obtained, for example in Nigeria by National Agency for Food, Drug Administration and control (NAFDAC) or mainly thanks to an international organization, IMPACT (International Medical Products Anti Counterfeiting Task Force) created by WHO in 2008, closely with INTERPOL and involving a total of 193 countries. In East Africa, a sub program of IMPACT, (operation MAMBA)13,14 led to the to arrest several manufacturers, wholesalers and retail pharmacists. It also allowed the seizure of destruction of counterfeit drugs valued at several billion of dollars. But at the end of the distribution chain, it is difficult and almost impossible to obtain significant results in Africa, where counterfeit drugs are often sold alongside vegetables in local markets or by hawkers (sidewalk markets)

Paper’s conclusions:

Tackling this network of criminal organizations at different levels is essential but not enough as it requires other approaches different from law enforcement and monitoring. One such measure could involve increasing the availability of low priced genuine drugs –particularly antimalarials – in developing countries. However, the risk is even with low prices, it will be easy for counterfeiters to produce and sell fake drugs at a much cheaper rate, because their main (if not only) expense is packaging.10

Finally, the solution would be to give antimalarials completely free of charge to developing countries which may imply a huge and perhaps unrealistic financial effor

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