I want to stress that this Bill, which has a very different structure from the original Bill introduced by Lord Saatchi, has nothing to do with research at all.
A great many confident claims were made about Chris Heaton-Harris’ Access to Medical Treatments (Innovation) Bill (AMTIB) at its Money Resolution debate on 3rd November, both by Heaton-Harris himself and by George Freeman, speaking on behalf of a Government that has done much to support the Bill. The AMTIB is the latest incarnation of Lord Saatchi’s much-criticised “Medical Anecdote Bill.”
The first two parts of this short series of articles looked at their claims that the new version of the Bill is “massively” different from the old one, and at claims the Bill does not alter the law of negligence. In both cases, we saw that these claims were untrue. This third part now looks at experimental treatment and finds that their claims that clinical research won’t be affected by the Bill are also untrue. At the same time, it also examines statements made by both MPs which fatally undermine the basic premise of the Bill they are promoting.
Freedom to experiment and fear of litigation
We start with a simple and fundamental point. Throughout the earlier incarnation of the Bill’s passage through the Lords, the claim was repeatedly made that the law prevents doctors from innovating, forcing them to deliver only a standard treatment, and that doctors cannot innovate because of a fear of litigation. This is how Lord Saatchi described it when introducing the Bill last June:
All cancer deaths are wasted lives. Scientific knowledge does not advance by one centimetre as a result of all these deaths, because the current law requires that the deceased receive only a standard procedure—the endless repetition of a failed experiment. In this way, the current law is a barrier to progress in curing cancer. It defines medical negligence as deviation from standard procedure.
The original version of the Bill sought to address this supposed problem by protecting the doctor from being sued for their treatment decisions, provided they followed a particular process in deciding to treat. Heaton-Harris carries the provisions for this doctor protection forward into his Bill almost word-for-word. This is a problem since, as Professor José Miola points out, this protection for doctors necessarily comes at the cost of patient safety. You cannot create a situation where a doctor is protected from being sued without at the same time creating a situation where their patient is prevented from suing them.
But now George Freeman says:
Let me confirm that this Bill has nothing at all to do with clinical research. It is to do with clarifying the freedoms that she is right to say that clinicians enjoy today. Clinicians are free to prescribe any treatment for their patients that they feel is appropriate on the basis of the clinical evidence. [emphasis added]
I reiterate that the Bill will in no way have any impact on our clinical research approvals and ethical regulatory infrastructure, which are world-class and a much prized jewel in our crown. The Bill merely—by saying merely, I do not mean to undermine its potential impact—deals with freedoms to prescribe innovatively, which already exist and are enjoyed by clinicians. It is important that everyone understands that doctors are already free to prescribe medicines. They have sovereignty in prescribing treatment to their patients where they believe there is good clinical evidence. [emphasis added]
My hon. Friend is right that it is a controversial proposition that fear of litigation for medical negligence is putting clinicians off innovating. The evidence that the Government received through the consultation was that some clinicians do feel that is a problem, but very few saw it as the principal problem or the principal obstacle. [emphasis added]
And Chris Heaton-Harris adds:
As we have already heard, doctors and surgeons say that they regularly innovate.
[…] doctors and registered medical practitioners innovate daily across the national health service. Litigation might be a consideration in the back of their minds, but they are all responsible doctors doing the best for their patients.
These points go to the heart of the Bill — even George Freeman and Chris Heaton-Harris now clearly accept that doctors already have the power to undertake experimental treatments, already widely use those powers, and that fear of litigation is not a major barrier to their practice. We see innovation all the time, with Ebola, with cancer. It is difficult to understand how George Freeman and Chris Heaton-Harris can state these reversals of Lord Saatchi’s original claims, yet still preserve almost verbatim the Bill text that built on those claims.
Be in no doubt, these admissions destroy the basis for Sections 3 and 4 of the Bill, right here. Doctors can already innovate, and they do, something that opponents of the Bill have been at pains to point out all along. The only difference is that under the AMTIB/Saatchi Bill, they would no longer have to bear responsibility if they act negligently in their treatment decisions. But if a few drivers don’t understand how traffic lights work, if they don’t understand when they should stop and when it is safe to go, then the solution is education, not to remove the traffic lights.
George Freeman and Chris Heaton-Harris have been very clear in their statements that the Bill does not in any way affect or undermine clinical research, throughout the Money Resolution debate. For example:
The database will not cover research and will not hamper recruitment to clinical trials.
It is very important that we clarify that this has nothing to do with clinical research.
The root of the problem here is that it would appear that Heaton-Harris, Freeman, and indeed the Department of Health, have overlooked the fact that clinical research doesn’t just happen in isolation from the rest of medical practice, and that you can affect something by altering the environment in which it exists. The mistake is clearly made here:
I want to make two things absolutely clear. First, this Bill, in law, would have no impact at all on clinical research. We in the Department have been very clear about that. If it in any way changed the basis on which clinical research is regulated, it would be a very serious matter, because we lead the world in terms of our ethical and regulatory controls on research, and it is vital that we do not affect that.
George Freeman appears to believe that if the Bill does not rewrite the regulatory framework of clinical trials, then it cannot affect them in any way. As we will shortly see, that is simply not true.
Clinical trials rely on the recruitment of patients suffering from the condition the treatment being trialled is intended to treat. This is obvious; you need to try out your new treatment on real live people to be confident that it works. But most trials seek to eliminate other possible causes for the results they get by randomly splitting the trial participants into two or more groups. One group will get the experimental treatment, another group will get the current best treatment or a placebo that has no pharmacological effect. In this way, we help to rule out the possibility that the results we see are due to another factor. If the treatment group clearly do better than the placebo group, when all other aspects of their care are the same, there’s a good chance our new treatment is an effective one.
But half our patients are not getting the new treatment. They may be getting nothing more than a sugar pill with no active ingredients. And that’s sometimes a difficult thing to accept. We have a tendency to assume that new treatments are good treatments, and we find it difficult to avoid a sneaking feeling that the placebo patients are somehow being hard-done by or disadvantaged. This can be especially hard to shake off if the condition we are attempting to treat is a serious, perhaps even terminal one.
It’s a view that goes to the heart of the AMTIB/Saatchi Bill, the belief that there are wonderful new treatments to be had, if only we could be brave enough to grasp them. We are pretty much conditioned to the idea that a new experimental treatment must be better than existing ones. It must be, right? Otherwise, why would they have gone to all the trouble of inventing it? Why would my doctor be suggesting it to me now?
In fact, it is far from given that new treatments are better than existing ones. There’s a very good chance that a new treatment is at best ineffective; at worst, it could be harmful. At the point when we are undertaking a clinical trial, we don’t actually know for certain whether the treatment works. The people getting the placebo could in fact be the lucky ones, as they avoid the potentially painful or awkward side-effects of a treatment that doesn’t actually work. A large proportion of drugs entering a clinical trial don’t make it through to market.
So how does the AMTIB/Saatchi Bill affect all this?
Well, it takes a special sort of person to agree to participate in a clinical trial, when it is difficult to know exactly how the new treatment will turn out, and moreover when they may not even receive the treatment at all. So picture yourself in your GP’s surgery, or with your private practitioner. You’ve been diagnosed with something nasty. Your doctor tells you there is a clinical trial available, under which there is a 50:50 chance you’ll get no treatment at all.
…or there’s this new experimental Saatchi treatment. It hasn’t been trialled yet, but it looks exciting. We don’t know for certain that it works, but what we do know for certain is that if you agree to follow this course, you’ll definitely get the treatment, none of this placebo nonsense.
Under these circumstances, it is almost certain that some patients will opt for the experimental treatment and not the trial. This will be true even before we consider that — human nature being what it is — the doctor is quite likely to inflate the possible advantages of experimental treatments they offer. After all, that’s one reason why trials are double-blinded where possible, so that even the person giving the treatment doesn’t know which one they are giving, because the doctor can introduce biases of their own.
It’s important to stress that patients cannot be criticised for choosing an experimental treatment instead of a clinical trial. It’s their life, their health, their choice. Patients can, and do, take the experimental route under current law, and the law balances their protections with those of the doctor. But it is inarguably true that a case where the Saatchi Bill encourages a doctor to offer an experimental treatment instead of a trial is a patient potentially lost to clinical research.
What’s especially tragic for clinical trial recruitment is that diversion into Saatchi treatments is likely to result in a drain of trial participants in exactly the areas where participants are already in shortest supply — in rare, intractable conditions with a poor prognosis. The peddling of well-meaning, but ultimately false, hope is likely to hit hardest in such cases, because the stakes are so high.
But it gets worse.
Don’t May Not Work
Clinical trials are expensive, often very expensive. But with the AMTIB/Saatchi Bill, pharmaceutical companies have an opportunity to bypass all that. If they can get their drugs into lucrative use on an experimental basis (with an experimental drug mark-up on the price, of course), why would they need to bother proceeding to a clinical trial?
The Bill will create an environment where money can be made marketing “experimental” treatments that haven’t yet been trialled. Worse, it will create a disincentive to trialling a drug, because trials cost money and there’s every possibility a treatment may end up not showing a clear benefit. Under the Bill, there’s no longer any need to show effectiveness before you can start making money.
In future, only the most promising drugs may ever undergo a trial. Meanwhile, the indifferent drugs, the minor tweaks to existing compounds, the stuff that got shelved because it wasn’t very good, all that could be dusted off and aggressively marketed to doctors as an experimental treatment for all manner of conditions. The orphan drug market is projected to grow into a multi-billion industry over the next few years, and the AMTIB/Saatchi Bill may go a long way to enabling that growth, at the expense of patient safety.
I reiterate that nothing in the Bill will interfere in any way with UK clinical research infrastructure.
While it is true that the rules for clinical trials are unaffected, as we have seen it is likely that we will see fewer clinical trials, and fewer participants in those trials. We cannot be certain, therefore, that clinical trials will be unaffected.
As we all know, individual innovation is incredibly important, but it is not a suitable substitute for medical research, which usually tests the efficacy of treatments in a systematic way. I hope that successful innovations will lead to systematic research projects as the evidence builds around a particular specialty and that they will thereby encourage more clinical trials.
Could it be possible that new areas for clinical trials could be identified by the database of treatments? Well, it is not impossible, but for it to happen a treatment would need to have a marked effect, enough to stand out in the background noise of varying data gathering methods, and it would need to have never been spotted before as a candidate for a trial (otherwise it would have been trialled already). Given that most new treatments are only incrementally better than their predecessors, and that the Saatchi database’s data collection will not be as systematic and controlled as a trial, it is unlikely we will identify promising new treatments and more likely that what we will have is a database of anecdotes, not suitable source material for identifying new trials. Indeed, Nigel Poole QC wryly commented that the database will be a record of negligent treatments, and thus a useful resource for ambulance-chasing lawyers.
I am concerned that the passage of the Bill, the conduct of the debate, and any legislation that may survive the process of parliamentary scrutiny do not in any way undermine public or patient trust and confidence in clinical research or mainstream medicine. Were it to do so, I would be very concerned and the Government would be unable to support it. I have made it very clear to my hon. Friend the Member for Daventry that that is the No. 1 consideration, and as this is his private Member’s Bill, it is his task to get it to a point at which the Government would feel able to support it. Public trust and confidence in our NHS and in our clinical research infrastructure is crucial.
It remains to be seen whether making doctors immune to prosecution when they carry out negligent experimental treatments will undermine patient trust. But, as we have seen, and as research charities and medical organisations have warned, the Bill certainly undermines clinical research.
The Government needs to wake up, and stop hand-holding this Bill through Parliament.