An Innovation Too Far?

NB – Update/ erratum here.  Ooops.

One of the things I’ve been doing since I last posted here has involved me looking at the Medical Innovation Bill – the so-called “Saatchi Bill”, after its titular sponsor.  Partly, I got interested out of necessity – Radio 4 invited me to go on to the Sunday programme to talk about it, and so I had to do some reading up pretty quickly.  (It wasn’t a classic performance, I admit; I wasn’t on top form, and it was live.  Noone swore, and noone died, but that’s about the best that can be said.)

It’s easy to see the appeal of the Bill: drugs can take ages to come to market, and off-label use can take a hell of a long time to get approval, and all the rest of it – and all the while, people are suffering and/ or dying.  It’s reasonable enough to want to do something to ameliorate the situation; and if there’s anecdotal evidence that something might work, or if a medic has a brainwave suggesting that drug D might prove useful for condition C – well, given all that, it’s perfectly understandable why we might want the law to provide some protection to said medic.  The sum of human knowledge will grow, people will get better, and it’s raindrops on roses and whiskers on kittens all the way; the Government seems satisfied that all’s well.  Accordingly, the Bill sets out to “encourage responsible innovation in medical treatment (and accordingly to deter innovation which is not responsible)” – that’s from §1(1) – and it’s main point is, according to §1(2), to ensure that

It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition, in the circumstances set out in subsection (3), if the decision to do so is taken responsibly.

Accordingly, §1(3) outlines that

[t]hose circumstances are where, in the doctor’s opinion—

(a) it is unclear whether the medical treatment that the doctor proposes to carry out has or would have the support of a responsible body of medical opinion, or

(b) the proposed treatment does not or would not have such support.

So far so good.  Time to break out the bright copper kettles and warm woollen mittens*, then?  Not so fast.

Not being a lawyer myself, I asked around my colleagues for a spot of advice.  They seem reasonably satisfied that the law already would protect medics who innovated, subject to the normal stuff from BolamBolitho, and all the rest of it.  To that extent, the Bill seems to do nothing that isn’t already done, and so is a bit superfluous.  On the other hand, it has the virtue of making the legal situation clear, and placing it on a firm legislative footing; so medics would be able to advert to a few lines of statue – and it’s a reasonably clearly-written Bill, by the standards of these things – rather than having to wade through the relevant case law.  That can’t be a bad thing.

But there are elements to the Bill that are, to my eyes, rather odd – and possibly positively undesirable.

One of the things that the Bill tries to do is to define “responsible” innovation.  That seems like an important task.  And some of its suggestions are reasonable enough on the face of it.  But one thing is worrying.  The criteria for establishing reasonable judgement is set out in §1(5), which requires that practitioners consider

(a) the relative risks that are, or can reasonably be expected to be, associated with the proposed treatment and other treatments,

(b) the likely success rates, in the doctor’s reasonable judgement, of the proposed treatment and other treatments,

(c) the likely consequences, in the doctor’s reasonable judgement, of carrying out, or failing to carry out, the proposed treatment and other treatments,

(d) opinions or requests expressed by or in relation to the patient, and

(e) opinions expressed by colleagues whose opinions appear to the doctor to be appropriate to take into account.

It’s 1(5)(e) that made me sit up.  As far as I can tell, there’s no particular guidance on the qualifications or experience that those colleagues should have; and that makes me worry about confirmation bias.  Imagine that you have – for the sake of argument – a tumour, and you also have enough money to go private.  You choose a doctor that seems amenable to you.  You also happen to wonder if there’s anything to this homeopathy malarkey.  One of the things that attracts you to the doctor is that he also appears sympathetic to unorthodox treatments.  And yes: there are doctors who think that way.

But here’s the rub: such a doctor is really only likely to consult colleagues about the reasonability of trying homeopathy who are of like mind, and who will foster the idea that homeopathy is, at worst, not an insane treatment strategy.  (For the sake of this post, I’m going to assume that homeopathy doesn’t work.  It’s not such a big assumption, really.)  There’s no stipulation in the Bill about ethics committees, or blind peer-review, or anything like that.

Indeed, the fact that mainstream doctors would run a mile is neither here nor there, given that, as we’ve seen, explicit protection from negligence claims is offered  in §1(3) when

(a) it is unclear whether the medical treatment that the doctor proposes to carry out has or would have the support of a responsible body of medical opinion, or

(b) the proposed treatment does not or would not have such support. [emphasis mine]

In other words: “Don’t worry if everyone except you and your mates think you’re nuts”.

Or, to put it another way, the Bill doesn’t simply codify and simplify what the law already says in respect of the protections offered to people who are considered by a responsible body of medical opinion to be acting reasonably.  It makes an innovation: and that innovation is to extend protection to those who would not be considered to be acting reasonably by a responsible body of medical opinion.

That leaves patients very vulnerable; and the fact that the Bill requires discussion and consent from them is neither here nor there, since they could well be clutching at straws or – at best – simply beholden to the idea that because doctor knows best in most cases, he does in this one too.  And – quite aside from it being in tension with its own §1(1) – I do worry that that’s an innovation too far.

*It occurs to me that Oscar Hammerstein’s mind was a straaaange place.

  • Nancy Herman

    Really? You are going to assume homeopathy doesn’t work. Stop right there.