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Counterfeit drugs: A plot worthy of John le Carrè
IJCA-25108; No of Pages 2 International Journal of Cardiology xxx (2017) xxx–xxx
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Editorial
Counterfeit drugs: A plot worthy of John le Carrè Raymond L. Woosley a,b,⁎, Peter J. Schwartz c a b c
University of Arizona, College of Medicine-Phoenix, AZ, USA AZCERT, Inc., Oro Valley, AZ, USA IRCCS Istituto Auxologico Italiano, Center for Cardiac Arrhythmias of Genetic Origin and Laboratory of Cardiovascular Genetics, Milan, Italy
a r t i c l e
i n f o
Article history: Received 1 June 2017 Accepted 6 June 2017 Available online xxxx
The tragic story of corporate greed and ruthless disregard for humanity, as told by John le Carrè in his book [1] and movie The Constant Gardener, opened a window on certain aspects of medicine in Africa. This was a fictional story about a pharmaceutical company giving outdated (expired) medicines to lure HIV patients into research studies where deadly side-effects went unreported and bodies were hidden in mass graves. One would like to think that this was just a story, a novel, and as such, far from reality. Unfortunately, reality beats fantasy. In this issue of the International Journal of Cardiology, Marie Antignac with Xavier Jouven and their associates show that such crimes persist and that some unscrupulous pharmaceutical marketers continue to take advantage of the world's most vulnerable and helpless people [2]. The World Health Organization (WHO) estimates that nearly 100,000 deaths occur in Africa each year because of counterfeit medications [3]. Antignac et al. have examined the content and purity of seven routinely prescribed cardiovascular medications (anticoagulants, antihypertensives, and statins) in 10 Sub-Saharan African countries. Shockingly, their research found that up to 50% percent of the cardiovascular medicines were sub-potent or inactive counterfeits [2]. As prescribers of medicines and members of the healthcare profession, we rely on and often take for granted the pharmaceutical quality of the medicines we prescribe and recommend to our patients. This study shows that we must all be vigilant to assure that the medications capable of saving and extending healthy lives for our patients are of full potency and not fake versions. The victims of sub-potent and ineffective medications cannot recognize the difference or protect themselves and must depend on us to help uncover this repugnant practice and prevent harm caused by substandard medications. The Authors ⁎ Corresponding author at: AZCERT, Inc., 1822 E. Innovation Park Dr., Oro Valley, AZ 85755, USA. E-mail address: [email protected] (R.L. Woosley).
conducted this very important work with public funding and will continue to collect samples and publish their results for the next five years. Unfortunately, this alone will not solve the problem and some public health agency should be given the independent funding and responsibility to carry on this important work as long as necessary. Antignac et al. used very sophisticated analytical chemistry technology to compare the actual amount of medication in each product to the labeled amount [2]. Because the products were so often sub-standard, it raises the question of what potential toxins could also be present in the products. The US Food and Drug administration tests products marketed in the US and regularly recalls pharmaceutical products because they contain bacterial or chemical toxins, glass shards, metal shavings, etc. It is very likely that the factories that make sub-potent or counterfeit products will also fail to keep these contaminants out of their products. As shocking as this report may be, one look into this verminous problem reveals its gigantic proportions. We mention here just a few glaring examples because we have realized how the majority of medical doctors working in the Western world lives in a state of “ignorant bliss” and are completely unaware of the extent and far reaching impact of this poorly regulated industry. A study of antimalarial drugs procured in the major cities of 6 African countries (Ghana, Kenya, Nigeria, Rwanda, Tanzania, and Uganda) situated in areas most highly endemic for malaria has demonstrated that 35% of drugs were substandard [4]. This favors drug resistance and jeopardizes malaria treatment globally. Another study in 17 countries, mostly African, along with Brazil, China, India, and Russia, tested 713 medicine packs for anti-tuberculosis treatment and found that 9% failed basic quality testing. The rate of failure was not uniform as it increased from 4% in middle-income countries to 10% in India to a dramatic 17% in Africa [5]. The use of these sub-potent products could create a massive drug resistance crisis which will be deadly in the long run. As with every dark story, there are not only villains moved by naked greed but also heroes, to be proud of. One of them, recognized by TIME magazine as “hero of global health” [6] was Professor Dora Akunyili (Fig. 1), director general of the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria between 2001 and 2008. She established as the Agency's first priority the eradication of counterfeit drugs. There was also a personal reason behind her commitment, as her diabetic sister Vivian died in her 20s from taking fake insulin. She was very successful and NAFDAC became a name that struck fear among everyone involved in the dirty business of counterfeit drugs. Not surprisingly, after a failed attempt to kidnap her son, criminals
http://dx.doi.org/10.1016/j.ijcard.2017.06.016 0167-5273/© 2017 Elsevier B.V. All rights reserved.
Please cite this article as: R.L. Woosley, P.J. Schwartz, Counterfeit drugs: A plot worthy of John le Carrè, Int J Cardiol (2017), http://dx.doi.org/ 10.1016/j.ijcard.2017.06.016
2
Editorial
In the practice of medicine, there are many principles of rational therapeutics to consider. The important work by Antignac et al. [2] identifies another that we must not forget: to consider the content and purity of the medications likely to be taken by our patients especially when they are not experiencing the desired clinical response. Even in the Western World where substandard medicines are often purchased on the internet, we should routinely ask “where do you obtain your medicines.” When John Le Carrè published The Constant Gardiner [1] there were speculations about his novel being based on actual events. In his “Author's Note” at the end of the book, he flatly denies that. However, he showed one of his gifts – his almost instinctive perception for the evil masquerading under the facade of socially respectable and dignified behavior – when he commented “As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard”. Conflict of interest The authors report no relationships that could be construed as a conflict of interest. References
Fig. 1. Dora Nkem Akunyili (14 July 1954–7 June 2014).
operating in the fake drug industry planned an assassination attempt. On December 26, 2003 her car was ambushed and many shots were fired with one bullet going through her headscarf and singeing her hair before exiting the windscreen of her car. The parallel with John Le Carrè's protagonist, Tessa, is striking considering that The Constant Gardiner [1] was published two years earlier in 2001. In the book, when the assassins found Tessa on Lake Turkana they did not miss.
[1] John Le Carrè, The Constant Gardiner, Scribner, New York, 2001, ISBN 0-743-28720-7 492. [2] M. Antignac, I.B. Diop, D. Macquart de Terline, M. Bernard, B. Do, S.M. Ikama, R. N'guetta, D.M. Balde, Y. Tchabi, A.S. Aly, I.A. Toure, P. Zabsonre, J.M.F. Damorou, J.L. Takombe, C. Fernandez, M. Tafflet, J.P. Empana, P.R. Plouin, K. Narayanan, E. Marijon, X. Jouven, Fighting fake medicines: first quality evaluation of cardiac drugs in Africa, Int. J. Cardiol. (2017) (in this issue). [3] P.N. Newton, M.D. Green, F.M. Fernandez, N.P. Day, N.J. White, Counterfeit antiinfective drugs, Lancet Infect. Dis. 6 (2006) 602–613. [4] R. Bate, P. Coticelli, R. Tren, A. Attaran, Antimalarial drug quality in the most severely malarious parts of Africa - a six country study, PLoS One 3 (2008), e2132. [5] R. Bate, P. Jensen, K. Hess, L. Mooney, J. Milligan, Substandard and falsified antituberculosis drugs: a preliminary field analysis, Int. J. Tuberc. Lung Dis. 17 (2013) 308–311. [6] TIME Press release October 17, 2005, New York, NY, USA.
Please cite this article as: R.L. Woosley, P.J. Schwartz, Counterfeit drugs: A plot worthy of John le Carrè, Int J Cardiol (2017), http://dx.doi.org/ 10.1016/j.ijcard.2017.06.016
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Editorial
Counterfeit drugs: A plot worthy of John le Carrè Raymond L. Woosley a,b,⁎, Peter J. Schwartz c a b c
University of Arizona, College of Medicine-Phoenix, AZ, USA AZCERT, Inc., Oro Valley, AZ, USA IRCCS Istituto Auxologico Italiano, Center for Cardiac Arrhythmias of Genetic Origin and Laboratory of Cardiovascular Genetics, Milan, Italy
a r t i c l e
i n f o
Article history: Received 1 June 2017 Accepted 6 June 2017 Available online xxxx
The tragic story of corporate greed and ruthless disregard for humanity, as told by John le Carrè in his book [1] and movie The Constant Gardener, opened a window on certain aspects of medicine in Africa. This was a fictional story about a pharmaceutical company giving outdated (expired) medicines to lure HIV patients into research studies where deadly side-effects went unreported and bodies were hidden in mass graves. One would like to think that this was just a story, a novel, and as such, far from reality. Unfortunately, reality beats fantasy. In this issue of the International Journal of Cardiology, Marie Antignac with Xavier Jouven and their associates show that such crimes persist and that some unscrupulous pharmaceutical marketers continue to take advantage of the world's most vulnerable and helpless people [2]. The World Health Organization (WHO) estimates that nearly 100,000 deaths occur in Africa each year because of counterfeit medications [3]. Antignac et al. have examined the content and purity of seven routinely prescribed cardiovascular medications (anticoagulants, antihypertensives, and statins) in 10 Sub-Saharan African countries. Shockingly, their research found that up to 50% percent of the cardiovascular medicines were sub-potent or inactive counterfeits [2]. As prescribers of medicines and members of the healthcare profession, we rely on and often take for granted the pharmaceutical quality of the medicines we prescribe and recommend to our patients. This study shows that we must all be vigilant to assure that the medications capable of saving and extending healthy lives for our patients are of full potency and not fake versions. The victims of sub-potent and ineffective medications cannot recognize the difference or protect themselves and must depend on us to help uncover this repugnant practice and prevent harm caused by substandard medications. The Authors ⁎ Corresponding author at: AZCERT, Inc., 1822 E. Innovation Park Dr., Oro Valley, AZ 85755, USA. E-mail address: [email protected] (R.L. Woosley).
conducted this very important work with public funding and will continue to collect samples and publish their results for the next five years. Unfortunately, this alone will not solve the problem and some public health agency should be given the independent funding and responsibility to carry on this important work as long as necessary. Antignac et al. used very sophisticated analytical chemistry technology to compare the actual amount of medication in each product to the labeled amount [2]. Because the products were so often sub-standard, it raises the question of what potential toxins could also be present in the products. The US Food and Drug administration tests products marketed in the US and regularly recalls pharmaceutical products because they contain bacterial or chemical toxins, glass shards, metal shavings, etc. It is very likely that the factories that make sub-potent or counterfeit products will also fail to keep these contaminants out of their products. As shocking as this report may be, one look into this verminous problem reveals its gigantic proportions. We mention here just a few glaring examples because we have realized how the majority of medical doctors working in the Western world lives in a state of “ignorant bliss” and are completely unaware of the extent and far reaching impact of this poorly regulated industry. A study of antimalarial drugs procured in the major cities of 6 African countries (Ghana, Kenya, Nigeria, Rwanda, Tanzania, and Uganda) situated in areas most highly endemic for malaria has demonstrated that 35% of drugs were substandard [4]. This favors drug resistance and jeopardizes malaria treatment globally. Another study in 17 countries, mostly African, along with Brazil, China, India, and Russia, tested 713 medicine packs for anti-tuberculosis treatment and found that 9% failed basic quality testing. The rate of failure was not uniform as it increased from 4% in middle-income countries to 10% in India to a dramatic 17% in Africa [5]. The use of these sub-potent products could create a massive drug resistance crisis which will be deadly in the long run. As with every dark story, there are not only villains moved by naked greed but also heroes, to be proud of. One of them, recognized by TIME magazine as “hero of global health” [6] was Professor Dora Akunyili (Fig. 1), director general of the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria between 2001 and 2008. She established as the Agency's first priority the eradication of counterfeit drugs. There was also a personal reason behind her commitment, as her diabetic sister Vivian died in her 20s from taking fake insulin. She was very successful and NAFDAC became a name that struck fear among everyone involved in the dirty business of counterfeit drugs. Not surprisingly, after a failed attempt to kidnap her son, criminals
http://dx.doi.org/10.1016/j.ijcard.2017.06.016 0167-5273/© 2017 Elsevier B.V. All rights reserved.
Please cite this article as: R.L. Woosley, P.J. Schwartz, Counterfeit drugs: A plot worthy of John le Carrè, Int J Cardiol (2017), http://dx.doi.org/ 10.1016/j.ijcard.2017.06.016
2
Editorial
In the practice of medicine, there are many principles of rational therapeutics to consider. The important work by Antignac et al. [2] identifies another that we must not forget: to consider the content and purity of the medications likely to be taken by our patients especially when they are not experiencing the desired clinical response. Even in the Western World where substandard medicines are often purchased on the internet, we should routinely ask “where do you obtain your medicines.” When John Le Carrè published The Constant Gardiner [1] there were speculations about his novel being based on actual events. In his “Author's Note” at the end of the book, he flatly denies that. However, he showed one of his gifts – his almost instinctive perception for the evil masquerading under the facade of socially respectable and dignified behavior – when he commented “As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard”. Conflict of interest The authors report no relationships that could be construed as a conflict of interest. References
Fig. 1. Dora Nkem Akunyili (14 July 1954–7 June 2014).
operating in the fake drug industry planned an assassination attempt. On December 26, 2003 her car was ambushed and many shots were fired with one bullet going through her headscarf and singeing her hair before exiting the windscreen of her car. The parallel with John Le Carrè's protagonist, Tessa, is striking considering that The Constant Gardiner [1] was published two years earlier in 2001. In the book, when the assassins found Tessa on Lake Turkana they did not miss.
[1] John Le Carrè, The Constant Gardiner, Scribner, New York, 2001, ISBN 0-743-28720-7 492. [2] M. Antignac, I.B. Diop, D. Macquart de Terline, M. Bernard, B. Do, S.M. Ikama, R. N'guetta, D.M. Balde, Y. Tchabi, A.S. Aly, I.A. Toure, P. Zabsonre, J.M.F. Damorou, J.L. Takombe, C. Fernandez, M. Tafflet, J.P. Empana, P.R. Plouin, K. Narayanan, E. Marijon, X. Jouven, Fighting fake medicines: first quality evaluation of cardiac drugs in Africa, Int. J. Cardiol. (2017) (in this issue). [3] P.N. Newton, M.D. Green, F.M. Fernandez, N.P. Day, N.J. White, Counterfeit antiinfective drugs, Lancet Infect. Dis. 6 (2006) 602–613. [4] R. Bate, P. Coticelli, R. Tren, A. Attaran, Antimalarial drug quality in the most severely malarious parts of Africa - a six country study, PLoS One 3 (2008), e2132. [5] R. Bate, P. Jensen, K. Hess, L. Mooney, J. Milligan, Substandard and falsified antituberculosis drugs: a preliminary field analysis, Int. J. Tuberc. Lung Dis. 17 (2013) 308–311. [6] TIME Press release October 17, 2005, New York, NY, USA.
Please cite this article as: R.L. Woosley, P.J. Schwartz, Counterfeit drugs: A plot worthy of John le Carrè, Int J Cardiol (2017), http://dx.doi.org/ 10.1016/j.ijcard.2017.06.016