So change the ethics then

After all, it’s not as if there isn’t a selection of ethical stances that one can take:

A place on a clinical trial is being advertised for $2 million in what is believed to be a world first which medical practitioners hope could transform a funding gap in researching rare cancers.

The trial place is being offered by a research team at the Children’s Hospital of Eastern Ontario Research Institute in Ottawa, led by Dr David Stojdl, to be part of the first human use of the Farmington Virus (FARV) to help combat brain tumours.

Dr Stodjl has said any donor who provides $2 million to enable this trial to go ahead will be guaranteed a place, either for personal use – providing the donor meets the inclusion criteria – or for any suitable patient of the donor’s choice.

His offer is believed to be the first time in medical history that such an attempt to sell a clinical trial place has been made.

Kate Law, director of clinical and population research at Cancer Research UK said the approach “looks to be a major cause of concern” and would not be possible in Britain because of ethical constraints.

Ethics being only, according to the moral principles that I hold, this should not happen. But other people can and do have different morals and thus different ethical stances.

I’m not, btw, commenting upon whether a place on a trial should or should not be auctioned in this manner. Rather, pointing out that “I don’t think this should happen” is not the trump card that it’s being played as.

 

15 thoughts on “So change the ethics then”

  1. “would not be possible in Britain because of ethical constraints.”

    She misspelled “ideological”.

  2. It should not be one’s trump card, but it seems to me it usually is.
    Take the Newsnight anchor who leads a debate for boxing to be banned “for safety reasons”. When the case is demolished (statistically safer than Rugby Union) she moves seamlessly to these horrible men and their horrible intent.
    Take the jumped up politician campaigning for an Englishman’s right to impose his cigarette smoke on others in pubs, but who wants all applications for betting shops refused because, and I quote, “there are more than enough of them already”.
    Take as many examples as you need.

  3. So, farewell then
    Science.
    You were
    Quite useful
    When you existed.

    Do you think someone willing to shell out 2 million is going to be content to have a 50% chance of getting the placebo? So the double blind is over.

  4. I’d prefer people die of brain cancer than see research trials get sold just like all other goods is the “ethics” on display here.

    I hope THEY get brain cancer.

  5. @bif,

    No placebo in Phase I (usually). But you do tend to start with dose escalation, so does the millionaire get to pick which dose he gets? Or wants the highest dose but to go first (defeating the safety object of escalation)?

    There isn’t, as usual, an easy answer to this one. I’m still thinking about it. Medical science is squishy, uncertainty, human values type stuff, we don’t have the luxuty of the subatomic certainty of physics. Which means a lot of semi-subjective decisions have to be taken and no one is going to like all of them.

  6. biG
    Yes there are some problems. There were no doubt some issues around testing the Pill for side effects, for example.

    But for a clinical trial you do need double blind. (Neither patient nor physician in the know. Otherwise it’s like having the court usher give out lists of previous convictions to the jury.

  7. I don’t quite understand the point of all these medical trials. Ebola kills 50% of those who catch it, yet we need to make sure the cure doesn’t cause any unpleasant side-effects? As long as the cure is no worse than the disease, it should be on the market.

  8. @bif, no you don’t “need double-blind” for a clinical trial. The majority of trials are not double-blind, including, off the top of my head, all the dozen or so trials I am working on at the moment. Some of them don’t even have more than one treatment arm. And yes, depending on the indication you can go all the way to market without doing double-blind trials, though probably most development programmes do at least one.

    Contraceptive is a classic example of stuff not done double-blind, even at the proof of efficacy phase. You simply design the trial to calculate a failure rate over a long enough time in a large enough group (and collect enough side-effect data) and it either passes muster or doesn’t. No comparator required (though in some regions the use of an active comparator is encouraged by the regulators as strongly as such approaches are hated by pharma).

    So, double blind is indeed doubleplusgood, but it’s not holy writ, particularly if it would be unethical to withhold [cancer] or conceal [contraceptive] treatment).

  9. @AndrewM,

    Any experimental Ebola treatment will get a fast-track trial done PDQ, this will not get tied up by the bureaucrats.

    “cure no worse than the disease” is the cornerstone of what the regulators do, they call it “benefit/risk assessment”. And yes, a treatment for a disease with a 50% kill rate will have a far lower safety hurdle to meet than for a disease that doesn’t kill. If you’re gonna die anyway you’ll accept a higher risk of side effects.

  10. Also, Ebola trials will be done in the back of beyond in West Africa where the long arm of the FDA reacheth not.

  11. And who says the guy paying $2M needs to be in a double blind test? Surely this Canadian can run 2 test groups, one full of rich people and one full of half blind paupers?

    Cue an outraged article at the Guardian on class war in medical research and the glories of the NHS 3…2…1…

  12. Ethics doesn’t stand alone, it is driven by values. In this case I believe the underlying value is one of fairness – you should have a chance of the life-saving cure whether you are rich or not. Of course life is not fair, but if paid-for place were additional to free places, rather instead of them, there would be no adverse effect for those unable or unwilling to pay, and thereby no ‘fairness’ grounds for objection.

  13. Well, a big ethical issue is the misrepresentation of the likelihood of being in a trial helping you. It’s being sold as an opportunity to get access to unlicensed medicines (when there are other legitimate, and less expensive, means). Statistically speaking, the chances are that medicine doesn’t work.

    Of course there are plenty of sick rich people who fund research into their personal diseases, and that’s great. But it’s hard to see how you will benefit from buying your way on to a trial.

  14. > Of course there are plenty of sick rich people who fund research into their personal diseases, and that’s great. But it’s hard to see how you will benefit from buying your way on to a trial.

    Buying your way onto a trial is funding research into your personal disease. Surely this scheme is just providing a little extra incentive to such rich people.

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