Ben Goldacre, The Guardian, Saturday 23 October 2010
This month it was revealed that US academics funded by NIH deliberately infected mentally incapacitated patients, prison inmates, sex workers, and soldiers from Guatemala with syphilis, gonorrhea, and chancroid during the 1940s.There has been outrage, and rightly so. Since the 1940s, regulations on consent have been tightened up.
But it’s interesting to look at who participates in medical trials today, and whether we would regard them as giving fully informed consent, without coercion.
Recruiting patients into clinical trials is generally difficult, and often a majority of those who are eligible decide not to participate. This is, in some respects, a systemic problem, as we have been very poor at embedding the idea of routinely resolving uncertainties about which treatments are best into the everyday practice of medicine.
My point is not that these studies are dangerous, because they are not. But in the US, where many are still unable to afford healthcare, clinical trials are frequently marketed as a way to access doctors appointments, scans, blood tests, and treatment for free. One study compared insurance status among people who either agreed or refused to participate in a clinical trial: participants are a diverse population, but notably they were 7 times more likely to have no health insurance than those who declined. Another looked at strategies to improve targeted recruitment among latinos, a group on average with far lower wages and poorer healthcare: 96% agreed to participate, a rate far higher than anyone would normally expect.
In large clinical trials such as these, a drug has usually been identified as being broadly safe – it may even be licensed already – and the study is designed to measure how effective the drug is, or give better guidance on the balance between benefits and risks.
“First in man” studies are different: here the risks are greater, and the picture is more stark. A drug, which has only been previously tested in animals, is given to a small number of healthy and disease-free people, mostly men, often unemployed, who then undergo painful, embarrassing, and risky procedures, in exchange for money.
This is a relatively new phenomenon. Up until the 1970s studies like these were conducted on prisoners, who are captured, compliant, stigmatised and in need of money. When concerns were raised about their ability to give meaningful and uncoerced consent, paid volunteers made a ready alternative.
This strange new profession has only recently begun to be formally documented in the work of anthropologists like Robert Abadie in his book “The professional guinea pig”. The industry refers to these participants with the oxymoron “paid volunteers”, and there is a universal pretence that they are not paid for their work, but merely reimbursed for their time and travel expenses. The participants themselves are under no such illusions.
Payment is often around $200 to $400 a day, studies can last for weeks or more, and participants will often do several studies in a year. Money is central to the process, and payment is often back-loaded so that you only receive full payment if you complete the study, unless you can prove your withdrawal was due to serious side effects. Participants are generally those with few economic alternatives, especially in america, and are frequently presented with lengthy and impenetrable consent forms which are hard to navigate and understand.
Nothing could be as bad as the frank and unacceptable coercion exposed this month in the Guatemala trials. Plainly there is a need for drugs to be tested in humans, and although many of those participating in “first in man” studies have lives where the scale of the payment is hard to resist, they do participate of their own free will.
But equally, we should not allow ourselves to ignore what happens in healthcare today. In the US, in particular, the reality is stark: poor people participate in early tests so that rich people can have better drugs.
(Sorry I was a week late posting this, I don’t think it was very good and I was away at the time, the column was leading up to a really great paper but I ran out of space and just had to file, I’ll do the uberpaper another time. Normal service will now resume.)