‘He’s a young, gorgeous muscley, hunky guy, and I walked in and he’s looking puffed out like the Elephant Man and he looks like a 45-year-old man who’s had a cardiac arrest.’
After visiting her critically ill British boyfriend in a London hospital in March this year, Adelaide woman Myfanwy Marshall was understandably shocked by his appearance. The 28-year-old man had suffered a violent reaction after a clinical drug trial went horribly wrong. The drug, which was developed by German-based pharmaceutical company TeGenero and known as TGN1412, was designed to treat diseases such as leukemia, rheumatoid arthritis and multiple sclerosis . Another man also fell critically ill after the tests, although two other volunteers escaped unharmed. Press reports said the men were paid $4750 to participate in the trial.
Chief Scientific officer at TeGenero, Thomas Hanke, said he was ‘devastated’ by the results, that the new drug had displayed no safety problems in past trials and apologised to the affected families. The case highlighted the dangers of drug trials even in a regulated country.
But what of clinical trials in the developing world? Western multinationals stand accused of performing dangerous tests on unsuspecting subjects in any number of poor nations around the globe. The Washington Post reported in early May that a ‘panel of Nigerian medical experts concluded that Pfizer Inc violated international law during a 1996 epidemic by testing an unapproved drug on children with brain infections at a field hospital.’
The report stated that Pfizer never obtained appropriate authorisation from the Nigerian Government to administer the untested drug to nearly 100 children and adults. Pfizer denied the charges.
Globalisation has brought undoubted benefits to multinational drug companies. New and emerging markets have allowed a wider range of test subjects, many of whom are illiterate and desperate for money. A generally unregulated environment means companies can get away with not fully informing individuals about the possible risks of their drugs; they may not even know themselves.
Take the example of GlaxoSmithKline and allegations it tested a Hepatitis E drug on thousands of unsuspecting Nepalese soldiers after r esearchers sealed a deal with the Royal Nepalese Army. According to reports, the US Government was directly involved in the deal. Writing in the American Journal of Bioethics, author Jason Andrews claims that the US in all likelihood threatened the Nepalese Government to not resist GlaxoSmithKline’s program, or aid would be cut.
This is not implausible. The US Armed Forces Research Institute of Medical Sciences has worked with many drug multinationals over the years, including GlaxoSmithKline.
There is surely something unethical about testing the effectiveness of an expensive drug in a country where it may never be available. An anonymous epidemiologist at Yale’s School of Medicine told NewKerala.com in January:
There’s no plan for getting the vaccine to the (Nepali) population, despite clearly pitching the trial as an attempt to address this disease for Nepalis. It appears that the vaccine will be developed as a traveller’s vaccine at best.
India has become one of the more popular destinations for 21st century clinical trials, alongside Thailand, Eastern Europe, China, Brazil and Argentina. Dr Hans Hogerzeil, Director of Medicine Policy and Standards at the World Health Organisation in Geneva, recently told the International Herald Tribune that, ‘you have a huge number of treatment-naÃ¯ve patients who have never been treated before and a lot of highly educated people and good infrastructure.’ International guidelines are essential, he says:
The patient really has to be informed what is being asked. You have to sit there. You have to explain it to them. You have to have material written in the local language.
It should also be essential that local populations benefit from the trials themselves, buying and using the drugs once approved.
The BBC recently produced a disturbing documentary called Drug Trials: The Dark Side, which claimed that, by 2010, there might be two million patients in India on drug trials. Six years ago, an experimental drug from the US known as M4N was injected into cancer patients in India without tests on animals first. It was later discovered that a number of patients were unaware they were involved in a clinical trial. The doctor who blew the whistle, Dr V Narayan Bhattathiri, told the BBC that he ‘couldn’t find any example of such a thing being done, maybe in the last 50 years or so. Maybe something similar could have happened in, say, concentration camps.’
Another doctor said that many of those who sign up for trials simply don’t understand the consent forms. ‘Most of the patients sign on the dotted line without understanding the nature and the consequences of what is being administered to them,’ said Dr Shashank Joshi.
It’s not just Western multinational drug firms violating basic ethical norms. In March 2004, India’s Supreme Court found two Indian biotech companies ‘openly conducting illegal clinical trials of new drugs on unsuspecting patients.’ The explosion of India’s middle class may have benefited a handful in the country, but the poor, once again, are left behind to fend for themselves.
A key problem in India is the absence of a law safeguarding volunteers of drug trials. Indian industry sources told the Asian Times in July 2004 that clinical trials were a massive money-spinner. Globally, the industry is predicted to be worth over US$6 billion.
Transparency International released its 2006 Global Corruption Report in mid-May and found that corruption within the health sector was a massive problem largely ignored by many governments. It reported: ‘ Doctors are often paid by pharmaceutical companies to recruit patients for clinical trials or sit on clinical trial boards while simultaneously on the payroll of the manufacturing company in question.’
Corruption within the pharmaceutical industry isn’t just a problem for the developing world. Many of the offending companies are based in the West and should be held to account. Only a concerted campaign by government and activists can ensure that clinical trials don’t contribute to the dark side of globalisation.
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