The Saatchi Bill – Stifling Innovation and Harming Patients

20th April 2014

The government is currently consulting on a new bill that – if passed – would fundamentally change the way in which medical professionals can decide on your treatment. If you care that the treatment you receive should be professionally delivered, evidence-based and that patients should have a means of redress for mistreatment, I urge you to respond to this consultation – you only have until 25th April 2014 – and make your views known. Details on how to respond to the consultation are at the end of this article.

Sorry, it’s quite long.

Introduction

The Medical Innovation Bill (or “Saatchi Bill” as it is popularly called after its proposer, Lord Saatchi) is currently being trumpeted across print and social media. Here is a bill that even has its own Twitter feed. The story that is being put about is that development of vital new treatments is being held back because medical professionals are afraid of negligence claims. Press coverage of the bill is, how can I put it, glowing.

The PR campaign has been very powerful, heart-string-tugging stuff, and some proponents have gone so far as to say that this bill is the one that will allow us to find a cure for cancer. The arguments are strong, slick, powerful.

And almost completely wrong.

This article sets out to explain how, rather than encouraging innovation, the Saatchi Bill would actually stifle it, and how, rather than helping patients, it will almost certainly lead to a great deal of harm.

I am not a medical professional, though I have a background working in the health service, clinical audit and a little bit of medical research. I have written this at a level that I can understand, which means that you can understand it too, and hopefully see for yourself where this bill clearly leads us.

Though the comments I make would also apply for any currently incurable illness, affliction or malady, from AIDS to CFS, because much of the discussion around the Saatchi Bill has been about finding a cure for cancer, that’s where I’ll focus most. It’s worth bearing in mind that the patients most affected here are the most vulnerable – likely to be terminally ill, desperate to find something, anything, to prolong their life or relieve their symptoms – and most likely to be prey to the peddling of false hope.

The draft Medical Innovations Bill (Saatchi Bill) is here. It’s very short, only three pages, so I recommend you have a read, even if you usually strenuously avoid such things, as I usually would. The points which most resonate to me are that the bill is designed to protect medical professionals when they make decisions that none of their colleagues would support, and that it specifically bans them from using the bill to carry out research.

In order for this bill to potentially be of value, either one or both of the following statements need to be true:

  • There are promising treatments available or in development, which are not being used because clinicians are being prevented by regulation from using them.
  • There are individual “maverick” doctors with wonderful new “pioneering” treatments who can’t get them developed.

Unfortunately, while both are popular stories in the media, they are actually just that: stories.

 What’s in the Lab?

So, first off, what the people pushing this bill would have us believe is that there are promising treatments out there, gathering dust on shelves, which are not being used because clinicians are afraid to use them. If only we could set the clinicians free, they tell us, then all these wonderful new treatments could be used.

I’m sorry, but this is not true.

Even if it were true, this bill would not help. If a pharmaceutical company, for example, is sitting on a brilliant new miracle cure drug, the last thing they will want to do is subject it to the scattergun of individual treatments in this way. There are no advantages and only disadvantages for them. They cannot use the treatments for research purposes, as the bill specifically bans them from doing so, and any adverse reactions which occur could potentially kill their wonder drug before they can get it authorised for mainstream use and start making real money from it.

 The Maverick Doctor

The idea of the maverick doctor with a miracle cure is an enduring one, in much the same way as the boffin inventing a wonderful new clean energy source in his garden shed, but such a person is incredibly rare. For every person with a good idea, there are a thousand quacks, pushing ineffective cancer treatment for massive profit, or selling you treatments for “mitochondrial dysfunction” which are claimed (without evidence) to help your CFS.

So what will the real effects of the Saatchi Bill be, and who will benefit from it?

 Pharmaceutical companies

One group that will clearly benefit will, I think, be the pharmaceutical companies. They will benefit in a number of ways. But first a quick bit of background.

Pharmaceutical companies spend a lot of money – billions – on research, with diminishing returns, it seems. It is now rare for a company to come up with a miracle breakthrough and instead they spend more and more time refining existing groups of drugs, extending their use, creating subtly different copies of existing treatments. The reasons for this are obvious – if you develop a new drug you can patent it and corner the market for a time, charging what you like for it. Once it’s out of patent anybody can make it and the price falls through the floor. So the pharmaceutical companies will make a slightly modified version of the drug, and patent it again, and promote that as being the new thing to use, charging handsomely for the “new” drug over the generic alternative. This is a bit of an aside, but an illuminating one – one study[1] estimated that £1 billion of the £9 billion NHS drug budget was being unnecessarily wasted on branded drugs when a generic would have done just as well. It gives us an idea of the sums involved here.

Another area where pharmaceutical companies can make extra money is in “off-label “ use. When drugs are authorised, it’s generally for treatment of a specific condition in a particular group of people. It’s hard and expensive to get authorisation for a drug in certain groups – children or pregnant women, for example – because it is very difficult to safely trial your drug in those groups directly. But a pain-killer licensed for use in adults will probably work in children, so the drug could be used “off-label” to treat children, because there is a reasonable expectation it would work. This is reasonable as far as it goes, but it becomes less supportable the further away from the original licence you go. What if you take a drug intended for treating diabetes, say, and use it for treating depression? It may seem fanciful, but drug companies have a bit of a history of cherry-picking unexpected results from their drug trials and spinning them into the claim of a useful effect. Sometimes drugs do successfully cross boundaries; thalidomide now has a new life as a drug used in the treatment of cancer and leprosy, for example, but these things should not be done on a whim. The Saatchi Bill, though, gives a doctor carte blanche to make a treatment decision even if none of his or her colleagues would support it. What is to stop that doctor going completely off piste? Nothing.

Now picture yourself as a rep for a pharmaceutical company. The Saatchi Bill gives GPs wider scope for prescribing. You’ve got a bunch of shiny new drugs in your portfolio, why not give them a nudge in the “right” direction?

But then, why stick with those boring old existing drugs, when there’s loads of experimental ones sitting on the shelf earning no income at all?

 But we don’t want to give you that, we want to sell you this…

As I mentioned above, trialling drugs, getting them authorised and on the market, is an expensive business. A pharmaceutical company may spend millions on developing a drug, fail to get it authorised, and after all the effort see no return on their investment. Now, with the Saatchi Bill, there’s a way to make money off those drugs.

A doctor could prescribe an experimental drug, and the drugs company could sell it to them. Simple as that. There’s no limit to this – the bill does not restrict the prescribing pattern of the medical professional at all. There’s no restriction that experimental drugs can only be used in terminal cases where there is no other possible treatment. We could see wholesale prescribing of experimental treatments for a whole range of ailments, of all kinds. And the costs would be monstrous – these are experimental treatments, the drugs will be expensive.

Here we start to see the scale of the problem. The Saatchi Bill is specifically intended to allow clinicians to make decision which no other clinician would agree is a good idea, and be protected for it. There is nothing to stop the scenario I have just described.

There have been many, many cases over the years where patient groups and the media have been mobilised, sometimes unwittingly, to demand the NHS prescribe a new “wonder drug” or prevent the withdrawal of an existing ineffective one. In these cases, the NHS comes under intolerable pressure to cave in to the demands. We will see a lot more of these cases. We will see a lot more abuse of “accelerated approval”, where drugs are fast-tracked, this time on the basis of patient pressure from existing recipients of an experimental treatment.

Does any of this matter? I think it does. Apart from the expense, the only treatments which will be offered via this experimental route will be the poor ones, the indifferent treatments with little effect or horrible side-effects. Think about it. If the treatment is any good, the drug company will want to make most profitable use of it. That means trials and licensing and a patent so they can market it exclusively. Prescribing the drug through the Saatchi Bill harms this goal: they can’t use any data they get from patients because research use is banned, and any side-effects or problems are only going to set them back. No, the only treatments to be Saatchi’d will be ones that are already licensed for some other use, or not very likely ever to reach licensing because they are not good enough. The Saatchi Bill allows the drug company to make some extra money from the inferior, shrapnel drugs in their portfolio.

But here we have a way in which Saatchi will block innovation. By opening up the field so that companies can get their unlicensed drugs earning money, there is now no incentive to develop them further. Why would they? They are already making money, and if the company spends all the money and effort on taking them through to authorisation, there is a chance they won’t make it through, which could actually harm the revenue they are already making on the drug. No, Saatchi will actually stifle innovation.

 Independent “healthcare” providers

This is the other group that stands to benefit. When we look at this bill, we have to consider not just how honest and diligent clinicians would use it, but how dishonest and incompetent clinicians would use it. And it is difficult to escape the conclusion that honest and diligent clinicians don’t actually need it, while dishonest and incompetent clinicians would have all their Christmases come at once. It is, in short, a quack’s charter.

To take a specific example, it would allow a cancer quack like Stanislaw Burzynski to operate in the UK. I won’t spend too long on this, but Burzynski is a doctor who operates a clinic in Texas, from where he claims to cure cancer. He has been running this clinic for more than three decades and, under the pretence of medical research, has been making millions from putting terminally ill patients through expensive and painful treatments. Then they die, sometimes from the cancer he claims to be curing and sometimes from sodium overdoses from his treatments.

The Saatchi Bill would allow a UK Burzynski to operate, make him almost impossible to stop, and he wouldn’t even need to run the pretence of clinical trials as a cover for his exploitation of vulnerable patients.

Here I’ll skip lightly over the fact that you can’t know a treatment is any good until you’ve tried it, and so it’s probable that a doctor will only know what treatments were responsible after they’ve carried out the treatment.

 So what about the patients?

Well, effectively this bill takes away many of the protections patients have against medical negligence. It’s worth taking a look at the consultation document for the bill because it takes quite a different approach to expressing the problem the bill is intended to solve than what has been circulating in the media. As far as the consultation document is concerned, the problem is the rise in clinical negligence claims and “our increasingly litigious culture”, and it shows us a graph demonstrating how the number of claims is increasing year on year. Now, we’ve no way of knowing from the bare figures how many of those claims arise from departure from accepted practice (what the Saatchi bill covers) and how many from poor treatment within accepted practice (incompetence, delays, wrong diagnosis, overdoses, that sort of thing), but the consultation document effectively tries to draw a parallel between those negligence claims and the freedom to deviate from accepted practice. Without knowing how many claims arise from such deviations from accepted practice, or how much clinicians feel constrained by the risk of litigation, such parallels are unwarranted.

So, rather than address the problem of clinical negligence directly, the bill seeks to make it almost impossible for a patient to make a clinical negligence claim if a doctor deviates from accepted practice. I’ll ram this point home: if a doctor decides to do something which all his colleagues say is stupid, wrong and negligent, he/she can still do it, and be protected by this bill. In essence, the Saatchi Bill drives a coach and horses through the protection of patients. As Dr Margaret McCartney puts it in her excellent post on the subject, this bill allows any doctor to:

 “propose anything and for it to be decreed ‘reasonable’. I am very clearly not a lawyer, but to pretend that this gives patients any protection from naked quackery would be misguided.”

And what do we gain? Nothing. The bill actually prevents research: we won’t get feedback on whether an experimental treatment works. Worse, we also won’t get feedback to tell us if it is harmful.

 Conclusion

There is no cure for cancer here. What we have instead is a new Wild West, an effectively lawless wasteground where treatments can be used in a scattergun approach, without any evidence they actually work. There is no research gain, no protection for the patient.

This bill approaches the problem of research and development of new treatments from entirely the wrong direction. Because of that, there is no way to fix this bill and have it work, because the approach is wrong. It acts as a disincentive to research, removes safeguards for patients while placing no duty on the clinician to provide any form of useful feedback on the effectiveness of the treatment, nor any limit on cost. Finding the one promising treatment among the noise of thousands will be impossible, because organised research is specifically banned.

It is hard to escape the conclusion that with the Saatchi Bill the government is trying in effect to de-regulate medical treatment and wash its hands of the negligence claims that will inevitably follow. I cannot understand how anybody, after even a moment’s thought, could think that this is in the interests of patients, and any MP who votes for this has some serious explaining to do.

We have a real problem in getting to grips with quacks pushing unproven and potentially dangerous treatments. We also have a problem in the speed with which ethics committees approve trials and treatments. Neither problem is helped by this bill, to put it mildly.

I urge you to respond to the consultation, before the closing date of 25th April 2014. It will also be interesting to see how your MP votes. This issue is pretty clear-cut, and if they vote for this bill there is a good chance they either haven’t understood it or they have some other motive for doing so.

Links:

Draft Bill here

Consultation Document here

You can respond here

As ever, use the comments to let me know why I am wrong.

Or contact me here.

Addendum 23/4/14: I linked above to a Telegraph article by Dominic Nutt. It would appear that, in penning this article extolling the claimed virtues of the Saatchi Bill, Mr. Nutt failed to declare that he is Director of Communications for the Saatchi Bill campaign. This is a serious omission.

 

Acknowledgements: Thanks to Ben Goldacre, whose books Bad Science and Bad Pharma illuminate pharmaceutical company practices I mention in this post, Bad Pharma in particular putting me on to the paper referenced below, and my friend @frozenwarning, for background info.

[1]  Moon JC, Flett AS, Godman BB, Grosso AM, Wierzbicki AS. Getting better value from the NHS drug budget. BMJ. 2010 Dec 17;341(dec17 1):c6449-c6449.

 

Pages on the Saatchi Bill

An introduction (20th April 2014):

The Saatchi Bill – Stifling Innovation and Harming Patients

Dishonesty in the Saatchi Campaign (10th May 2014):

So Untrue It’s Not True

A list of comments on the bill by organisations and individuals (10th May 2014):

An Inexhaustively Incomplete (But Completely Exhausting) List of Saatchi Bill Comments

An article about one particular campaign supporter (12th May 2014):

Well Struck

A discussion of the bill and its shortcomings (Guardian Science blogs guest post) (22nd May 2014):

The Saatchi medical innovation bill will put patients at the mercy of quacks

A comment on the promotion of the latest draft (3rd June 2014):

La-la-la-la (not listening)

A view on lack of patient protection in the latest draft (5th June 2014):

No protection against quackery

A view on research shortcomings in the latest draft (10th June 2014):

Gambling With Lives

Comments on the consultation process (13th June 2014):

Selling the Sizzle

The continuing PR (12th September 2014)

Never Say You’re Wrong

An Open Letter to Lord Blencathra (22nd October 2014)

Dear Lord

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2 Responses to “The Saatchi Bill – Stifling Innovation and Harming Patients”

  1. George Shuttleworth February 18, 2015 at 11:49 am #

    Fascinating to see this Bill pushed through Parliament. Non-consensual experimentation, with significant injuries and deaths, and marked deviations from standard treatment, in return for significant payment from external corporations to three hospital consultants using public facilities and public patients, has recently been identified at a hospital within the British Isles. The commercial element was the factor the medics never thought would be uncovered. The Saatchi Bill if it becomes law will ultimately lead to the vanquishing of the rancid and utterly corrupt medical profession. God, if he exists, certainly is working in very mysterious ways.

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