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LAST December, GlaxoSmithKline was found guilty of irregularities in obtaining informed consent and fined by an Argentinean court in relation to trials of its pneumococcal vaccine, Synflorix, in rural provinces of that country.
According to a report in The Lancet, local regulators found parents of some children in the trial might not have fully understood the consent forms they signed.
GSK, which is appealing the decision, responded by saying it conducted clinical trials “to the same high standards, irrespective of where in the world they are run”.
That may be, but it’s not the first pharmaceutical company to face questions about its conduct of trials in the developing world. Late last year, the UK’s The Independent newspaper reported on a number of trials conducted at the hospital set up to care for survivors of India’s Bhopal gas disaster.
Ethics aside, it seems bewildering that anyone would think they could get generalisable data from a trial population that had been exposed to a major chemical incident, but apparently a number of pharmaceutical giants saw that as no obstacle.
Patients from the hospital were enrolled in one arm of a large multicentre study of AstraZeneca’s platelet inhibitor, ticagrelor, described last year by the Therapeutics Goods Administration as the “pivotal trial” when it approved the drug for use in patients with acute coronary syndromes.
According to The Independent, one of the trial patients was 64-year-old former electrician Ramadhar Shrivastave, a Bhopal survivor who had attended the hospital for a post-myocardial infarction angioplasty.
He told the newspaper he did not even know he was enrolled in a trial until it was all over. Nor did he know the name or purpose of the unlabelled pills he took for about two years — until he was abruptly told his course of medication had finished and he did not need to come back.
Yes, he had been given a form to sign at the outset, but it was in English and he didn’t understand it.
“Of course I am angry,” he said. “But what can I do? We are poor people … If I’d known it was a drug trial, I never would have agreed … These people should do trials on their own families, not poor people like me.”
AstraZeneca said it had strict processes in place to monitor trials and ensure proper consent was obtained. When it was discovered some of the Bhopal patients had not “properly consented” during the ticagrelor trial, this was “promptly corrected by the investigator”.
In both these cases, the failure to obtain proper consent may have been an honest mistake, one that was corrected by the companies as soon as they became aware of it. But, when you start looking into the conduct of clinical trials in developing countries more broadly, it’s hard not to start worrying about such issues.
Desperately poor participants may be offered a cash payment for taking part, or medical treatment that would otherwise be beyond their reach. Those with little education may be too easily convinced by clinicians or other recruiters, who receive a fee for each enrolment.
It’s hard to escape the conclusion that at least some companies adopt a pretty cavalier approach, taking advantage of lower costs and less stringent regulatory environments while showing a less than admirable regard for participants’ welfare.
Aggravating the problem is the fact that the actual conduct of trials can be outsourced to a contract research organisation, allowing the originating company to distance itself from any malpractice if things go wrong.
Clinical trials do, of course, need to be conducted in the developing world — provided the research is designed to alleviate the health problems of people in those countries.
But, many of these trials are not aimed at the diseases that cause much of the morbidity in developing countries and many of the treatments that result are likely to remain out of reach for the trials’ impoverished recruits.
It can be hard to resist the conclusion that we in the West are simply outsourcing the risks and obligations associated with trialling new drugs to developing countries, just as we rely on their sweatshops to produce our cheap consumer goods.
Jane McCredie is a Sydney-based science and medicine writer.
Posted 20 February 2012
I think Jane’s most interesting statement is at the end. There is an obligation on the community to participate in clinical trials if as a community we want the benefit of modern medications. Clinical triallists need to engage the community to get more support for this concept. This applies particularly to new concept medications. We should stop abusing the goodwill of the public with phase 3 me too marketing trials.
Jane McCredie’s story confirms the reasons for the (sparse) objections to the World Medical Association’s attempt in 1999 to “modernise” the 1964 Declaration of Helsinki by relaxing the guidelines on researchers’ duty of medical care to the subjects of a therapeutic trial.
The 1999 amendments were proposed by the American Medical Association. They wanted to change the wording of the Declaration from: “Every patient in a trial should be assured of the best proven diagnostic and therapeutic care.” to add: “That would otherwise be available to him or her”.
This would have opened the floodgates for the exploitation of subjects from Third World countries, where the best care may have been close to nothing.
It seems Big Pharma has got around the issue in other ways.