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Third world trials are not the way to advance
There are other ways of assessing safety without using animals but it is not possible to do trials on medications without human involvement.
We can’t expect to see stickers proclaiming “not tested on humans” to appear on pill boxes anytime soon. However there are some ethical issues around trials of medications that should be ringing alarm bells.
There is an increasing trend to outsource work to developing countries. Phone companies and banks have jumped on board and so too has the pharmaceutical industry.
I was disturbed to read how one company was fined $US93,000 in Argentina over the deaths of 14 babies in a vaccine trial.
It is important to note that it was not the vaccine that caused the deaths, and the company is appealing the decision. Two doctors were also fined.
The real issue is how the trial was conducted. There were allegations of illiterate patients being pressured by doctors (who were recruited by the company) to sign 28-page agreements for their babies to be part of the trial.
The Buenos Aires Herald reported that since 2007 some 15,000 babies under the age of one were recruited into trials – all came from poor families who had attended public hospitals.
Paediatrician Ana Marchese, who reported the matter to the Argentine Federation of Health Professionals, was quoted as saying that “laboratories can’t experiment in Europe or the US so they come and do it in third world countries”.
If this was an isolated incident it would be bad enough, but it is not.
Indian authorities have asked 44 pharmaceutical manufacturers to explain why compensation has not been paid to people who have died during trials. Some 671 deaths were reported in 2010 (up from 637 the previous year and 288 in 2008).
Compensation was allegedly paid to as few as three families in 2010.
Only 26 deaths were felt to be due to the medications and naturally many people recruited were not in perfect health. The issue was again recruitment and consent.
Pharmaceutical news website Pharmalot reports that two ‘brokers’ in India were jailed in 2011 for recruiting poor illiterate women into a clinical trial for a breast cancer drug.
If even one tenth of these allegations are true we all need to be alarmed. We need clinical trials to advance medical practice. Trials done in the developed world are subject to rigorous checks and ethical reviews. Obviously developing countries lack the necessary infrastructure. This does not excuse what is essentially experimenting on vulnerable people.
Recruitment of poor and illiterate people is preying on the vulnerable. There is no dispute that monies are offered to people to sign up. There is dispute as to whether what is promised is delivered.
People in third world countries are not second-class global citizens who can be experimented on so that those of us in the first world can have new drugs. As a first step we need to be better informed about what happens in the name of research.
If we won’t use products tested unethically on animals then we should not use products unethically tested on humans- wherever they may live.
www.drjoe.net.au