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On 3rd February, the Welsh Assembly government voted unanimously to reject the Medical Innovation Bill. Assembly Ministers from across the political spectrum were united in their condemnation of a bill that Mark Drakeford, Minister for Health and Social Services, described as “a solution in search of a problem, and not a very sound solution at that.”

The Medical Innovation Bill, more commonly referred to as the “Saatchi Bill”, is currently being debated in the House of Commons, having already passed through the Lords at the hands of its proposer, Lord Saatchi. If you have heard of this bill at all, you’ve probably heard of it as the Bill that will cure cancer. You may have heard that it will allow doctors, who are apparently terrified of the law, to create new treatments that will cure a whole host of terrible diseases.

So why would the Welsh government not want this bill, which promises to cure cancer? To understand why they oppose it, we need to look more closely at the reality underlying the claims being made for it. Along the way, we will see how power and PR can manipulate political discussion and how vulnerable the Parliamentary process is to a powerful individual with connections and a determination that he is right. For the positive claims being made for the Saatchi Bill are wrong and, if MPs do not come to realise this, then in the next few weeks they will pass into law a deeply regressive change to medical practice. This change is likely to result in harm to many, many patients and strip them of fundamental protections against mistreatment.

How Can an Act of Parliament Cure Cancer?

This was the title that greeted the reader of Lord Saatchi’s first briefing into his Medical Innovation Bill. He was clear about his plan: “I intend to cure cancer, you see. I mean to do it. I expect to do it.” The problem, as he saw it, was that the law demands doctors must only use “standard treatments” and cannot deviate from standard practice, because to do so would result in a negligence claim.

Unfortunately, this narrative is entirely false. In truth, doctors innovate all the time, and have strong protections to back them up when they do. None of the organisations you might expect to know if there were such a problem – the BMA, the GMC, the Medical Defence Union (whose job is to try to keep doctors out of court) Action Against Medical Accidents, the Academy of Medical Royal Colleges, the major medical, medical protection, research and patient organisations – have found any evidence that litigation is a barrier to innovation. There are genuine barriers, such as funding, but litigation is not one of them. Nevertheless, the bill’s premise rests on this point: free doctors from the law, and the cure for cancer will be there for the taking.

However, freeing doctors from the law has potential drawbacks, and it’s easy to see what they are. If your doctor harms you, you may want to be able to seek redress personally, and we may as a society want to prevent that doctor repeatedly doing the same harmful thing to others.

But, say the bill’s promoters, patients are still protected by the law, it’s just that under our new bill a doctor can check to find out if what she is doing is okay before she does it. She is protected from being sued only if she carries out the appropriate checks in preparation for carrying out the treatment. As Lord Saatchi put it himself at Committee Stage in the House of Lords, the fundamental purpose of the bill is:

simply to bring forward the Bolam test to the point of treatment, so that doctors can be reassured in advance that they are innovating in a manner that the law will regard and uphold as responsible.

But there are problems with attempting to take this approach. By drawing up a procedure for doctors to follow, at the end of which they are immune from being sued, the bill is making a deliberate move to prevent the treatment decision from  being challenged in court. That is the purpose of the bill after all – to give doctors certainty they won’t be sued for their treatment decisions. But in doing so, it takes all the responsibility for deciding whether the treatment decision is appropriate and invests it in the individual doctor; in effect they are acting as their own judge and jury. This is terribly vulnerable to abuse. Instead of being able to check whether the treatment was supportable by a body of medical opinion (the Bolam test), and also had a logical basis (Bolitho), a court would only be able to check whether the right boxes were ticked when deciding to treat; the actual treatment itself is placed beyond the reach of the law.

In this situation, where the courts are shut out of oversight of the treatment itself, the procedures a doctor needs to follow need to be absolutely watertight, because if something goes wrong, the bill allows no review of the decision, and no redress for the patient. We would need to see in the bill a test at least as strong as the application of Bolam and Bolitho in court would have been, because those are the tests it is explicitly replacing.

The bill’s promoters claim that their test for responsible treatment is as good as the current law, perhaps even better. Unfortunately, this claim doesn’t appear to be borne out by reality. All a doctor effectively has to do in deciding to treat under the bill is to “obtain the views of one or more appropriately qualified doctors” and take those views in to account, along with the possible risks and benefits of the treatment. They do not have to follow the advice of the colleague they obtain views from; they can actually proceed without the agreement of anybody else, providing “there are reasonable grounds for doing so.” Effectively the decision to treat, which treatment to give, the judgement on whether it is a responsible thing to do, all these decisions would rest with one person – the treating doctor. The process of obtaining views has deliberately been made informal, out of a desire not to make the colleague being consulted actually bear responsibility for the advice they give.

You may have your own views on when it is appropriate for a court to get involved in a treatment decision, but by no stretch of the imagination is an informal discussion with a colleague equivalent to a detailed examination of all the facts of the situation (when that informally-consulted colleague may not be independent, may not see the patient’s notes or anything detailed about the case, and who may, remember, have their vehement disagreement over-ruled). That’s before you get to the fact that the “Saatchi Test” occurs before treatment, so clearly can’t examine its outcome.

You may, if you are feeling concerned at this apparent weakening of the supervision of treatment decisions, console yourself with the thought that it only applies to terminal patients, who are otherwise left with no other option. Sorry, no. Leaving aside the fact that such patients still deserve the same rights and protections as everyone else, meaning the bill would still be unfair even if it only applied to terminal cancer, it actually applies to all patients and all conditions, however major or minor, regardless of whether there is an existing effective treatment. Lord Saatchi and the government (who support the bill) have resisted all attempts to define what circumstances the bill applies to, or even what “established treatment” means, because they want the individual doctor to decide whether they are innovating and also to choose whether to act under the bill. This leads to the curious situation where they will get to choose which law applies to them, like a motorist, caught doing 45mph, deciding whether to be charged under the law that says the speed limit is 30mph or the one that says it is 60mph.

This intentional lack of definition leaves the bill with a breathtaking scope. For example, campaigners for the bill have talked about wanting it because it will allow the prescription of unlicensed medication. But this happens all the time now; the majority of prescribing for children is for medicine not licensed for that use, for instance. Is it right that your child’s routine medication may no longer come under the protection of the law? It is by no means clear that you would even know; the bill requires that details of the treatment be recorded in the patient’s notes, it doesn’t say the patient needs to be informed.

You may think that it would have been prudent to consult experts in medicine or the current law before the bill was put forward. In fact, they were asked. The Department of Health ran a consultation, which closed in April 2014. But Lord Saatchi did not wait for its results to be published before redrafting his bill and pushing it through the Lords, accompanied by his own self-produced report concentrating only on the positive responses from his own supplementary consultation channels. In this way, the overwhelmingly negative response from medical, legal and patient organisations was ignored in favour of the results of a petition and web page campaign run by his own team. That campaign was promoted with misleading rhetoric, favouring bold statements about the desire to cure awful diseases rather than an opportunity to read the bill itself. And, of course, you can’t answer no to a petition. In essence, within a petition you are asking everyone who agrees to step forward, and denying a means of response to any dissenting views.

Research

Would any of this matter, so long as the bill actually made it possible to find new cures for diseases? Well, unfortunately, it’s unlikely even to do that.

The story of an individual doctor stumbling across a miracle cure is just that: a story. Medical research is painstaking and time-consuming for a reason. It is hard to establish for certain whether a treatment works, or works better than established alternatives. It is hard to pick out good results from the background noise of random chance, and to exclude all the confounding factors that could have contributed to or masked the results we see.

The Saatchi Bill drives a coach and horses through all this. As a joint statement by organisations including The Academy of Medical Sciences, the Association of Medical Research Charities, the Medical Research Council, the Wellcome Trust, the Motor Neurone Disease Association and the British Heart Foundation says, the bill is likely to “discourage patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis, leading to a failure to develop the robust evidence of efficacy necessary to support wider adoption.” 

The bill’s supposed innovation register added with much fanfare at the last moment in the Lords would be no substitute, even if it existed in reality, because without co-ordination of how the treatments are given, in what doses and via what methods, without control patients for comparison, and without detailed and structured follow-up, the level of noise becomes deafening. What remains is an incomplete series of unconnected anecdotes. Not for nothing did Dr Sarah Wollaston MP rename it the Medical Anecdote Bill. In any case, the innovation register doesn’t exist, and the bill doesn’t create it. All the bill does is require a doctor to comply with any professional requirements that may exist to record the treatment, but no such professional requirements actually exist, and the only organisation that could create such a requirement – the GMC – weren’t told about this, don’t think it’s appropriate, and don’t think they could enforce it even if it were made a requirement.

So with the bill we abandon structured, carefully-thought-through research in favour of a scattergun approach of individual treatments, and we don’t even bother to collect the results in a systematic way. Even if we thought this was helpful, we wouldn’t need the bill to do it. We could do it right now, without any need to endanger patients by tinkering with their protections.

The PR campaign

If the basis of advertising is to accentuate the positive aspects of your product while playing down the negatives, the Saatchi Bill campaign has had its work cut out. There are seemingly no positive aspects to this bill, yet it is likely to cause significant problems for patients, for doctors and for research. Yet the Saatchi Bill has been driven forward by a slick PR machine, perhaps unsurprisingly given Lord Saatchi’s background in that industry. Almost all the media coverage has been driven by the bill team’s campaign, notably in the bill’s “media partner” the Telegraph, some penned by Saatchi, some penned by the campaign’s director (not always identifying himself in that role). The Telegraph ran three articles in two days around the time of the third reading in the House of Lords, while other pieces have appeared in the Guardian and the Mail. All have been pumped with Saatchi campaign PR, which exclude or mischaracterise opposition. You would not know, from the media coverage, of the near-universal condemnation that has met the bill from the medical and research communities, or the Welsh Assembly’s unanimous rejection of it. When Lord Saatchi claims, as he does in the Telegraph, that all honest opponents have had their concerns met, does he therefore mean that the British Medical Association are dishonest? Or the General Medical Council, which regulates all doctors? Or the Royal Medical Colleges? Or the Welsh Assembly?

This misrepresentation has been the defining character of a campaign that has featured, along with that nominated media partner, its own Twitter and Facebook accounts, and no less than two websites pumping PR by the bucket-load. When opposition appears, the campaign ignores it, as with the expert consultation responses, or attacks it, as with Lord Saatchi’s astounding assault on more than 100 oncologists – front-line cancer experts - who wrote to the Times to oppose the bill. Are they dishonest too? At the start of the campaign Saatchi wanted to erect statues in their honour, now he says “How I pity their patients.” Yet while Lord Saatchi likens cancer doctors to the cast of Downton Abbey, riding around in their carriages, he enlists as support for his cause – without any apparent sense of irony - a motley assortment of lords and Prince Charles’ step-son. To these he adds Lord Woolf, cited as the authority on doctors being sued for innovating, but who can’t remember any actual cases, and Lord Blencathra, who told Eddie Mair on Radio 4’s PM programme that all lawyers should be rounded up for experimentation or euthanised. This is beyond parody.

But it hasn’t just been PR that has seen the bill get this far. When the Welsh Assembly voted unanimously to reject the bill in Wales, it wasn’t simply because they had seen through the marketing hype. It was also a demonstration of how a government operates when it isn’t fettered by backroom deals and “round table meetings”, blurred lines between government responsibilities and private members’ interests, and the overbearing influence of a man on a mission who cannot be reasoned with.

Conclusion

There seems to be a general misconception that new treatments are good treatments. Actually, the majority of untested treatments will turn out, once tested, to be at best ineffective and at worst actively harmful. And as Professor Michael Baum says, there are many patients that we can’t cure but no patients we can’t hurt. All patients have something to lose.

While Saatchi characterises the opposition for the bill as being chiefly composed of greedy lawyers, including one firm he singles out for particular opprobrium because of a mistake completely unrelated to the bill, he doesn’t just overlook the true weight of the opposition and his own possible conflict of interest. He also reveals an important point. The point is this: we all make mistakes, every one of us, or do things that may later be thought regrettable. It is important, when we make those mistakes, that we can examine them, learn from them, and try to make sure we don’t make the same mistakes again. If Lord Saatchi’s bill passes, it will make it much harder to learn from our mistakes in medicine, and much harder to avoid repeating them.