The Buenos Aires Herald today announced that GlaxoSmithKline, the global pharmaceutical giant, has been fined 400,000 Argentinian pesos after the deaths of 14 babies during clinical trials in Argentina. That’s about £59,500, from a company worth around £73.8 billion, the 5th largest company on FTSE.
Two doctors were also fined 300,000 ARS each, for their involvement in the trials which were carried out between 2007 – 2008. GSK were trialling a vaccine against pneumococcal bacteria, and recruited around 150,000 babies under the age of one for the trial.
GSK were charged with experimenting on humans and falsifying parental consent for babies to be involved with the trial. Witnesses claimed doctors involved with the clinical trial bullied illiterate parents into signing to 28-page consent forms, and leading parents to believe their child would not receive any other vaccines if permission to take part in the clinical trial was refused.
Witnesses also state that many people who wanted to leave the programme were not allowed to, and that doctors did not respond to calls by concerned parents and carers when their children displayed adverse reactions to the vaccines.
GSK have denied any wrongdoing, and claimed that none of the babies’ deaths were related to the trial. They say that all the babies that died had been given a placebo, and are going to appeal against the fines. They also deny bribing participants, but have not commented on the tactics described by witnesses in the court case.
Clinical trials of drugs mostly destined for sale in the developed world are increasingly “offshored” developing countries, with Latin American and other “second world” countries a firm favourite due to their combination of lax regulations and health infrastructure sufficient for conducting trials. GSK would have found it relatively easy to recruit participants for this trial in Argentina (as well as Panama and Colombia, the other sites for this trial) compared with say the USA or UK, and labour and other overheads would also come at a reduced cost. GSK can use bullying tactics to get access to the bodies of babies from poor families in the third world, when such an approach just wouldn’t fly in the UK or USA.
Adriana Petryna has written extensively on this topic, and a free PDF of her 2007 article ‘Clinical Trials Offshored: Private Sector Science and Public Health’ is available here, and her book ‘When Experiments Travel: Clinical Trials and the Global Search for Human Subjects‘ also deals with this subject in depth. Petryna does well to highlight the irony of clinical trials being conducted among populations far too poor to afford the drugs that are developed as a result of them. This shows GSK’s claim that “Only 12 [babies in the clinical trial] have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria” to be a somewhat moot point: as respiratory diseases are predominantly linked to poverty in Latin America, its not likely that GSK will be giving away the fruits of their labour to the children most in need of it for free.
Of course I’m not arguing against the development of vaccines and the use of clinical trials altogether, but the GSK case once again highlights how Big Pharma can cut costs, cut corners, and carry out their research in developing countries without fear of reprisal and with big profits in mind. After all, a fine of £58,000 for a company worth £73.8 billion is barely a drop in the ocean.