Degrees of consent

October 29th, 2010 by Ben Goldacre in bad science, big pharma, regulating research | 8 Comments »

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.)

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8 Responses

  1. Regression To Norm said,

    October 31, 2010 at 12:06 pm

    Just felt sorry for this posting not having any comments.
    It’s a perfectly acceptable article Ben.
    Clearly someone has to be first to try any drug. Equally clearly it shouldn’t be me. Unless desperate to benifit from the promised results of a new drug coercion will always be required. Money seems the least worst option.

  2. Dr Spence said,

    October 31, 2010 at 5:11 pm


    I’ve run several clinical pharmacology studies in healthy volunteers.There is no pretense that the subjects are not paid in addition to other costs incurred. Also, unlike Regression to he Norm, I have been a volunteer in first in man studies. The US data is interesting but does not, I think, reflect the situation everywhere. I was a volunteer as a student (in the UK) and students are often volunteers in other countries. In India, as you might expect, the volunteer pool is normally from the poorer people (before anyone reacts to this, Indian law does not allow first in man studies in Indian subjects for drugs developed outside of India). The present system works – I’d love to hear of a better one.

  3. Edd S said,

    November 1, 2010 at 3:22 pm

    I read something about this a while ago, may have been New Scientist. The additional points raised there also mentioned the quality of data you get from the career guinea pigs. If people are jumping from one trial to the next, what effect is that having on their body? what rare drug interactions are happening and are these causing anomalous results? How much are/can people lie to get on the higher paying trials?

  4. mahdian said,

    November 1, 2010 at 11:52 pm

    Thanks for the thought-provoking post.

    The same logic applies to the military, and other jobs that have significant risks. People in bad economic conditions are overrepresented in all such jobs, so it could be argued that when looking at the big picture, there is some degree of coercion in finding “volunteers” for these jobs.

    Paying people for risky tasks such as drug testing or fighting in the military might still be our best alternative, but it’s good to keep in mind that the moral justification for this is not entirely clear cut.

  5. alexnharvey said,

    November 4, 2010 at 3:09 pm

    An alternative would be to operate a system similar to jury service (but non coercive) ie you would simply ask a random sample from the electoral roll to participate.

    IRBs do consider the reimbuirsement level carefully to try to ensure that it is not so high that participant’s have too great an incentive to participate and therefore not consider all the risks.

  6. criv said,

    November 5, 2010 at 2:39 pm

    The horrors of medical experimentation without consent (Nazis, Japanese in WW2, etc) and more recent and underhand experiments (Tuskegee) have led to the legislation to protect patients, however the new problem of ‘paid volunteers’ is a worrying one. Young Australian males funding their travels with clinical trials, and there has been at least one case where they have failed to disclose prior trial participation and have died.

    Add to this now the increasing biobanking activities – thorny issues of consent where it is unlikely to benefit the patient or their family – although altruism is a major drive in patients consenting to their tissue/samples being stored. Read ‘The Immortal Life of Henrietta Lacks’ – her HeLa cells will be familiar to most scientists, and yet her surviving family feel confused and cheated by their relative’s ‘gift’ which was never consented to. They ask questions like ‘have they cloned her?’. Thorny interesting issues.

  7. Matanza said,

    November 9, 2010 at 11:53 am

    It is rarely a good deal to sell your health.
    Clearly it is better if it is actually selling (for money) than being forced to do it.
    The question is very delicate and I don’t see a better system from where I stand.
    Obviously some humans must be the first to try a new drug. It is always risky. Of course every effort is normally made to minimize the risk, based on the pre-clinical observations on animals and cell cultures.
    The moral questions are many and all of them are difficult:

    – What is the most acceptable incentive for people to risk their life and health?
    – What about the animals in the pre-clinical trials? It isn’t nice for them too.
    – Is it really a responsible option to develop new drugs and therefore extend people’s life on a overpopulated planet?
    This way we run into the risk of planetary destruction by means of ecological catastrophe. Also many species have to die to become food or just free the space for all these humans.
    Another problem from this is that the population in the developed world is getting older which poses problems for all the social systems to an extend of destroying them.

    From my point of view the question of clinical trials is a close relative to the fundamental moral question of all life – does necessary someone has to die in order for someone else to live?
    The answer at this point of human development is still “yes”.

    Maybe there will be time when people will do no harm to themselves and the other species. Maybe we will move in space and occupy other planets or have global ecological and breeding politics.
    Maybe some day the human physiology will be lacking any secrets for us and the drug trials will be merely computer simulations.

    Until this moment someone has to risk and the best and most “fair” incentive which we can imagine is money.

  8. mykerri said,

    January 22, 2014 at 11:56 am

    Just a question – do you have anything good to say about clinical research? Would be interested to read this.