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  'People have to insist on fair drugs'

It is increasingly common for new pharmaceutical products to be tested in developing countries. Unfortunately, the drug trials that take place in less affluent parts of the world often fall short of international ethical norms and codes of practice. To reverse these worrying trends, people need to insist that all clinical research on humans meets the highest ethical standards, argues investigative reporter Sonia Shah.

Sonia Shah (picture: Cameron Laird)

‘Some doctors accuse me of hanging out the dirty washing,’ concedes investigative reporter Sonia Shah, author of the book The Body Hunters – Testing new drugs on the world’s poorest patients (published in 2006). ‘They say that by publicizing problems, I am interfering with essential medical research. I guess they feel threatened by what I do.’
‘My response is that, if you believe in human rights, you have to respect them all the time, not just when it suits you,’ the writer continues. ‘Breaking the rules on clinical testing can – and does – have far-reaching implications. Malpractice can undermine confidence in western medicine, for example.’
More and more often, drugs companies arrange for their products – most of which are intended for use in the west – to be tested in developing countries and low-wage economies. The reasons include cost, lenient supervision regimes, the ability to get things done quickly and the ease with which subjects can be recruited. After researching a journalistic article about this phenomenon, Shah was motivated to write a book on the way clinical trials are run in developing countries.
It proved to be quite a challenge, because information and material were difficult to obtain and publishers saw little commercial gain and considerable risk in bringing out a book on such a controversial subject. However, Shah’s book has been followed by various studies, reports and public statements confirming that some drugs companies are – to varying degrees – failing to follow international ethical guidelines and codes of conduct on human medical research. The accusation is that the companies in question are exploiting the vulnerability of poor and illiterate people who have no medical insurance. The underdeveloped healthcare systems in many less affluent regions mean that ‘ordinary’ treatment is unavailable or unaffordable for such people. As a result, participation in a clinical trial is often the only way to get help. This is the conclusion of, for example, research commissioned by Wemos and the Centre for Research on Multinational Corporations (SOMO).

Vulnerable population
‘Information about clinical trials is hard to come by, which immediately gives one cause for concern about the way they are organized,’ says Shah. ‘Especially in countries where there is no established system of research ethics and companies experiment on a vulnerable population.’
‘Greater transparency is needed with regard to protocols, trial centers, etc., so that patients, the people who speak for them, non-governmental organizations and journalists can play a role in making sure that clinical trials are conducted fairly. Access to information should not be restricted to the regulators and ethics committees, which work in almost total secrecy. We have seen more than enough cases of unethical practice and people’s rights being ignored to know that the supervision these bodies provide is not enough to prevent abuse.’
In her accessibly written book, Shah describes a number of (unethical) clinical trials, the resulting commotion and the outcomes. She also explains why the pharmaceutical industry is turning to the developing world and why local doctors and patients are so willing to cooperate. A fascinating picture emerges of the power that drugs companies wield and where their interests lie. Shah hopes that the book will open the eyes of her readers.
‘I believe that there is already a lot of suspicion surrounding the involvement of big drugs companies in poor countries,’ she says. ‘Some of the suspicions are reactionary and misplaced, however. We need to be skeptical and to keep asking questions, but we mustn’t allow ourselves to become paranoid.’

Fair drugs
Shah has now moved on to investigating other matters; she is currently working on a book about malaria. Nevertheless, she retains an interest in the ethics of clinical trials. Which is why she volunteered her support to the international campaign for ‘fair’ drugs, Shah has added her name to the ever-growing list of signatories, because she believes that ‘the involvement of the general public is needed to ensure that experiments on people meet the highest ethical standards.’
According to Shah, everyone who benefits from new drugs should be demanding that clinical trials are fair and ethical. The general public can and must send a clear message to the decision-makers, she argues. Shah goes on to say that people mustn’t be discouraged or intimidated by the enormous power of the pharmaceutical industry: ‘Collectively, ordinary people can stand up to the drugs companies. We have seen before how public pressure to respect human rights and therefore to uphold ethical standards can put a stop to the corrupt practices of powerful groups.’ Another important factor is that we already have standards for ethical medical research on people. The basic principles are enshrined in various international treaties, such as the World Medical Association’s Declaration of Helsinki – regarded worldwide as an authoritative statement of ethical values.
‘All the appropriate standards are there in black and white,’ emphasizes Shah. ‘The problem is that they are not being followed. Freely given informed consent, a reasonable probability that the research population stands to gain from the results, the availability of proper medical care: these are all established ethical principles, laid down in internationally sanctioned documents. It’s just a question of getting people to respect them!’

Shah traces commitment back to her roots
Sonia Shah (1969) was born and raised in the USA, where her Indian parents practiced medicine. While growing up, however, Shah regularly went to visit relatives in Mumbai and Bangalore, and was moved by the poverty, disease and injustice that she witnessed. She consequently developed a lifelong interest in the inequalities between and within societies.
Shah studied journalism, philosophy and neuroscience. She has written for The Washington Post, The Boston Globe, New Scientist and other newspapers and journals. In her books, she has examined the activities of the oil industry and the pharmaceutical industry – the latter being the subject of The Body Hunters – Testing new drugs on the world’s poorest patients (2006). The Body Hunters describes how and why multinational companies, in their quest to develop new, lucrative drugs, sponsor clinical trials in developing countries, where ethical controls are minimal and patients – often left desperate by the lack of proper health care – need little persuasion to participate. Based on several years’ research and reporting from Africa and Asia, the book uses real-life examples to illustrate the developments that concern Shah. It has already been translated into French, Japanese and Italian. For more information, visit

This is an extended and translated version of a Dutch article by journalist Babs Verblackt, first published in the Wemos Newsletter and on the Wemos website in 2009. Translation: Taalcentrum-VU.

5 February 2010



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