The Medical Innovation Bill, which would leave patients unprotected in the face of reckless medical experimentation, is before Parliament once more. The prospect should worry all of us

[The Lib Dems] have killed the Medical Innovation Bill. It is dead. By killing the Bill they have killed the hopes of thousands of cancer patients. It is as simple as that. Nick Clegg has handed down a death sentence to cancer patients.

These were Lord Saatchi’s words back in February, when his Medical Innovation Bill ran out of debating time in the last Parliament. While it seems a bit much to lay blame on the Lib Dems for his Private Member’s bill running out of private member’s debating time, there are other parts of this statement that are more in need of challenging. Firstly, as we shall see, the Saatchi Bill is far more likely to harm thousands of patients than save them; stopping the bill is the best thing that could have been done for patient safety.

Secondly, the Bill is not dead.

There has been no fanfare. The Bill’s Twitter feeds and websites, previously so industrious, have been silent. There have been no fulsome articles planted in the Telegraph (the Bill’s media partner). This time, when the Bill returns to the House of Lords on Monday 8th June, Lord Saatchi must be hoping that nobody notices. Normally, because this is a reboot, he would have to start again from scratch but, ever one to work the system to maximum advantage, the Saatchi campaign is aiming to suspend normal Parliamentary procedure, firing the Bill through the Lords in a single day and straight on to the Commons, a contingency normally only exercised in situations of urgent national security. The justification for this shortcutting of debate is presumably to be found in this article on the Bill’s website:

It has been the subject of a Department of Health consultation, and the team have consulted and debated widely across the medical and legal professions for two years. The Bill has received numerous amendments refining the process and improving patient safety.

It is clear that the Saatchi campaign team think they have laid sufficient groundwork for the Bill, and it doesn’t need to be discussed any further. Unfortunately, what that article doesn’t mention is that the Department of Health (DH) consultation found the majority of responding organisations were opposed to the Bill, while the Saatchi campaign side-lined this inconvenient data in favour of a petition signed by individuals who had been given misleading information. It doesn’t say that the vast weight of medical, medico-legal, medical protection and patient safety organisations remain opposed to the Bill.

It also doesn’t say that, despite repeated attempts to fix the Bill made by Lord Saatchi’s noble colleagues in the House of Lords, almost none of their suggested fixes made it into the Bill. In fact, only seven out of more than two thousand suggested words were accepted, and those seven were simply the deletion of a redundant phrase. Lord Winston, who was present at every stage in the Lords, described the nature of the Bill’s passage to me as “not good for legislation and not really parliament’s finest moment.”

While medical organisations have looked on in horror and fervently hoped the Bill would at some point be fixed, it has proven remarkably impervious to positive amendment. In short, the Bill has not been amended by anybody other than Lord Saatchi himself and, as we will see in a moment, Saatchi does not share the views of the medical or legal professions when it comes to medicine or the law.

First a recap. What is this zombie bill and why, like all zombies, does it seem so short of brains?

The Saatchi Bill

I’ve covered the Bill in detail on this blog and on the Stop the Saatchi Bill site. In brief, it has come about because of Lord Saatchi’s belief that the law prevents doctors from innovating, and that cancer treatment in particular has failed to advance because doctors fear the legal repercussions. As he put it, “Scientific discovery comes to a ‘dead halt’ at the bedside of the cancer victim.” Yet this basic foundation for the Bill is simply not true, and one does not even need to venture beyond the Bill’s media partner — the Telegraph — to find examples of major innovations happening all the time in the UK. As pioneering cancer surgeon Professor Michael Baum says, discussing a 40 year career at the cutting edge of cancer research, “never once have I had to consult a lawyer to endorse a research protocol. Never once have I, or any of the hundreds of collaborators in our programmes of clinical trials of novel therapy, been threatened by litigation.”

Could there be more research? Yes. Are there barriers to innovation? Yes indeed. There are major difficulties to be faced in the development of new treatments, with access to those treatments and with funding. With so many clear genuine targets for his Bill to aim at, it takes a truly special draftsman to manage to miss every single one of them. But miss every one of them the Bill does.

This would not matter much if the Bill were harmless. But it is very far from harmless, because the way it goes about dealing with the imagined problem of fear of the law is by attempting to make it impossible for patients to sue for negligence. It simply drives a coach and horses through clinical negligence law. Moreover, while the Bill has been marketed as being for patients with terminal illness for which there is no current cure, it actually applies to treatments for any condition, major or minor, regardless of whether there is an existing effective treatment. It applies equally well to ingrown toenails as to terminal cancer.

Lord Saatchi’s campaign has resisted all attempts to put a limit on its reach or even to define what is meant by innovative treatment. What constitutes a departure from the standard range of treatments? Don’t know. What barriers prevent the use of a treatment that has already been shown to be useless, or even harmful? None. This vagueness means that it is possible to interpret the Bill extremely broadly.

For example, the majority of paediatric prescribing is “off-label” for drugs that have not actually been clinically tested in children. What happens if this falls under the umbrella of the Bill? Millions of prescriptions for millions of children could be denied the protection of the law. As Nigel Poole QC puts it, “If the Saatchi Bill is passed there will come a time when a child is seriously harmed by negligent treatment and the child receives no compensation because the doctor has a ‘Saatchi defence’.”

This vagueness of definition is deliberate, because the Bill intentionally makes the individual doctor the judge, jury and (potentially) executioner on their own clinical decisions, partly to avoid inadvertently making anyone who gives the doctor advice liable for those decisions. If the doctor makes a bad decision, or even a string of them, they may remain immune from any comeback, whether their treatments are unproven or even if they have been disproven. Even if they make a decision no responsible colleague would support.

Small wonder the quacks are circling.

The Quacks are Circling

Here is where we justify the seemingly overblown headline at the top of this article, the claim that the Saatchi Bill may harm thousands. For patients to be harmed, it only takes a well-meaning but misguided doctor, who is sure they are on to something new and wonderful. History is replete with medical failures: oxygen for premature babies, steroids for head injuries. These were treatments that seemed logical but which turned out to be harmful.

And then you get to the treatments which have no logical basis.

It is illuminating that the director of the Dr Rath Research Institute has tweeted to welcome the revival of the Bill. The Rath Institute’s founder, Matthias Rath, has promoted vitamin supplements as a supposed cure for all manner of ailments, up to and including AIDS.

When the South African government abandoned established evidence-based methods of AIDS treatment, such as anti-retrovirals and mother-baby transmission prevention, in favour of unproven treatments including the vitamin mega-doses promoted by Rath, it is estimated that it resulted in more than 330,000 unnecessary deaths between 1999 and 2007. If these studies are accurate, the numbers are simply staggering.

Whatever your ailment, there is a quack waiting to take your money (and possibly your life) giving you a dangerous, unproven or even disproven treatment for it. Coffee enema for your cancer? Check. Bleach enema for your autism? Check. Homeopathy as a substitute for real malaria vaccination? Check check check. The Saatchi Bill gives them all a green light, with no comeback if it all goes horribly wrong.

The Campaign

It is ironic, given that the proposed Psychoactive Substances Bill is intended to “protect hard-working citizens from the risks posted by untested, unknown and potential harmful drugs” that the Saatchi Bill should be working so hard to expose people to untested, unknown and potentially harmful drugs. But here we are, staring down the barrel of a Bill that would cause genuine harm, and is so widely opposed. It’s hard to get medics and lawyers to agree on anything, yet they are united here in opposition of this Bill, and their voice is not being heard. It is genuinely possible this Bill may pass.

It may pass because Lord Saatchi has made almost all the running, with a well-orchestrated PR campaign. The campaign has been careless of the facts, and operated through misleading articles placed in the media, not always making clear the author was a paid member of Saatchi’s campaign. There have been misleading petitions, misinformation over the consultation, claims that have been incorrect. All the while, Saatchi has dominated debate in the Lords carefully shepherding his own amendments through, while rejecting all others.

Defending the Indefensible

In the real world, where innovation happens all the time and doctors don’t fear legal repercussions, the Bill’s only purpose is to protect doctors who cannot otherwise defend their actions, who want to do something indefensible, something no responsible body of opinion would support. This does not help patients.

There is hope. Away from Lord Saatchi’s influence, there has been vocal opposition in the Commons, from Dr Sarah Wollaston and then-MP Dr Julian Huppert. In the National Assembly for Wales, there was unanimous cross-party opposition to the Bill, the Assembly voting 58–0 against it. But this Bill desperately needs now to be properly examined in Westminster, and not short-cut as Lord Saatchi is trying to do, or better still it should be abandoned as folly.

A demonstration of the strength of opposition outside of Parliament was also given at a HealthWatch-UK debate on the Bill held on 4th March. Professor Sir Michael Rawlins (chair of the MHRA), and Daniel Greenberg (the Bill’s legal draftsman), spoke for the Bill. Nick Ross (broadcaster and President of HealthWatch) and Nigel Poole QC spoke against it. The event was recorded, and is available to view on-line.

While Rawlins listed a number of innovations (that had all occurred without the Bill), and tried to link them to a need to change the law, Ross spoke of the UK’s proud history and culture of innovation, all carried out under the current law. While Greenberg harangued the audience with the claim that the Bill was coming whether they wanted it or not, Poole warned of its risks. Members of the audience, medics and legal experts, joined the discussion. Dr Malcolm McKenzie spoke of innovation in an emergency setting. Jane Ridley spoke about compassion and preparation in end-of-life care. Nobody could be found among the audience with a good word for the Bill.

Then came a bizarre moment which, in microcosm, exemplified the campaign for the Bill, as Mike Rawlins unleashed a thundering tirade at a member of the audience, for a perceived slight he had supposedly given Lord Saatchi. But the audience member hadn’t made the comment, and Rawlins had taken aim at the wrong target.

Much like Lord Saatchi’s Bill itself.