Who should test our drugs?

So it turns out that one of the many things that is done for us that we would rather not think about is testing our drugs.

The terrible story of six men who suffered severe complications in the trial of TGN1412 should make us pause to ask how we choose which of us will test new drugs.

The media have coyly referred to the men as "volunteers". In one sense they are: industry guidelines require that trials should not be advertised as a way to make a living, and that payment for testing can only for the time and inconvenience it caused.  But they are not really "volunteers" because that they take part for money.  Drugs are tested mainly students and the unemployed, who are paid between £120 and £150 a day. In an interview on the World at One on Wednesday, one such ‘volunteer’ said that he took part because testing drugs was an easy way to earn money.  (Why else would they do it?)

More than 100,000 people take part in clinical trials every year in the UK.  The Medicines and Healthcare Products Regulatory Authority (MHRA), which reviews the testing of the drug on animals and in laboratories and the conditions of any human trial, say that 1,100 clinical trials are currently under way in Britain, involving between 10 and 120 patients. Of those, 284 are phase one trials, the riskiest stage and the first testing on humans, typically involving healthy subjects.

While I am opposed to unnecessary testing on animals, I am in favour of testing drugs on animals first before they are tried in humans, if the scientists believe that this will help to reduce the risks to people when the drugs are eventually tested in humans. But eventually we do have to test new drugs in humans.  The question then arises: who should those people be? 

This is a case in which we need some people in a society to make a sacrifice, by taking a risk that can be detrimental to their health and sometimes fatal, for a broader public benefit.  

One option is to offer payments sufficient to induce people to take part in the trials.  My inner economist has no problem with paying other people to take risks that we would rather not take ourselves.  In one sense no different than paying people to fight wars or to go down coal mines.   But drug testing is not a profession that requires training and experience.  Nor is it particularly inconvenient.  I could not be an effective fire fighter without proper training, and that would be a career.  But any of us at random could test a drug.  The egalitarian in me feels very uncomfortable with the notion that we should rely on the poor being so hard-up that they are willing to risk discomfort, their future health and perhaps their lives to test a drug that, on average, they will never need themselves.  Unlike fire-fighters, the only reason it is them, and not us, taking this risk is that they need the money more than we do.

In principle, an alternative approach would be to make drug testing like jury service, based on random selection of citizens. You would receive a message in a brown envelope:  "You have been randomly selected to test a new drug.  Please present yourself to Northwick Park Hospital at 9am on Monday morning."    True, this would require people to make a sacrifice that they would probably rather not make, but such are the costs that somebody has to bear for the tremendous benefits of new drugs.  Why should it not be you, from time to time?  (There might be an opt-out: I have decided not to take part in this trial, and recognise that this means that I will not be permitted to use any pharmaceutical product that I may need in the future.)

If we do think that it is acceptable to allow people to sell their bodies to medical science to test our drugs because we don’t want the burden to fall on society through random ballots, then we should have the courage of our convictions:

  • the ABPI guidelines which limit the payments that can be made in drugs trials are hypocrisy verging on market fixing.  If we are going to pay people to take part in trials, we should at least let them negotiate a decent payment.  It is self-delusional to pretend they are not doing it for the money.
  • we should also allow poor people to rent out their wombs as surrogate mothers, and to sell body parts such as kidneys or corneas, to people who are willing to pay for them.  There is no logic in saying that people can be paid to risk their lives testing drugs, but not be paid to donate a body part to someone who needs it.

We were all shocked at the suggestion in the recent Oscar-winning film, The Constant Gardener, that pharmaceutical companies might exploit Africans to test new products.  In that case, part of the allegation was that the people being treated as guinea pigs had not given informed consent: nobody is making such a claim about the people in the UK who take part in trials. But it is a difficult line to draw. If we are prepared to let the disadvantaged in our own society take these risks on our behalf, then why not outsource the whole business to people in countries who need the money even more? 

3 thoughts on “Who should test our drugs?”

  1. These testing solutions (forcing animals, paying poor humans, selecting random humans) are all pretty sickening in my view (though I have met 1 or 2 people who were happy to make some easy money in this way.)The truly outrageous thing for me is that we don’t actually need all these crazy drugs. They pollute people and they pollute the Earth. Herbs and other traditional therapies are good enough. Such things have already been tested and proven over thousands of years.These drug trials tell us very little. You can establish that a particular drug will not instantly kill people, or make them severely ill (though obviously not in this case), but the tests tell us nothing about the long term effects of a drug, or its effects in combination with other drugs. It is a truly frightening business, as The Constant Gardener showed.

  2. I’m all for testing on humans the people are told that there are risks i have never had a terrible experience and if anyone has an address were i can have a look for more test that have been done please write a message.

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