The Saatchi Bill: Deregulating Drug Safety Testing by Stealth

What is the purpose of the Saatchi Bill? That may seem an odd question: the full name of the Bill is ‘the Medical Innovation Bill’ and that is what is usually put forward as its purpose, other than in more hyperbolic PR flourishes when it is occasionally represented as ‘a Bill to cure cancer’.

But there has been expert evidence aplenty that doctors are not prevented by innovating by the law at present – to give just one example here’s the head of professional standards at the Medical defence Union http://www.bmj.com/content/350/bmj.h531/rr . If people who really do know say the Bill is not needed why does its sponsor, Lord Saatchi, plough on with the Bill virtually unchanged? It could be down to his personality, as argued here http://www.statsguy.co.uk/the-saatchi-bill/. That piece is both well researched and well argued, but I disagree with the conclusion.

A more honest title for the Bill would be ‘the Deregulation of Medical Safety Testing Bill’. I’m quite prepared to believe that Lord Saatchi is acting partly from altruistic motives (though it would be foolish to dismiss too lightly the evidence he does stand to make a significant profit personally. See https://opendemocracy.net/ourkingdom/anne-williams/maurice-saatchi-his-medical-innovation-bill-and-booming-%E2%80%98orphan-drugs%E2%80%99-mark#.VMKgBPMucv8.twitter).  If Maurice Saatchi is a free market fundamentalist, who genuinely believes that ‘the magic of the market’ will solve any problem it follows that any regulation – even testing medical drugs for safety before they can be prescribed – is holding back progress.

It is entirely possible that during his wife’s illness Lord Saatchi asked his contacts in the pharmaceutical industry why more could not be done and was told “we have lots of drugs sitting on the shelf which might be effective, but we can’t use them because it’s such a long and expensive business to get them tested and authorised for use.” Rather than get into the complex detail of how drugs are tested he hit upon a Gordian knot type of solution: if doctors could use untested drugs without any penalty if it went wrong they would use then even if they had not been tested.

Had the proposal been phrased as ‘let’s allow doctors to use untested drugs without any repercussions if they harm patients’ it would have been dismissed as ”mad” (as my GP said when I put this idea to her). Thalidomide would have been mentioned.

Interestingly the Saatchi Bill is far from alone. Across the USA various ‘Right To Try’ laws have been proposed, often sold as ‘Dallas Buyers Club’ laws. As Science Based Medicine notes http://www.sciencebasedmedicine.org/the-illusions-of-right-to-try-laws/ movies are not usually sound reasons to write laws. The US Food and Drugs Administration has long been a bête noire of the US far right and it is no great surprise that the Goldwater Institute has thrown itself behind these efforts, even helpfully drafting legislation for states to enact.

When the UK Saatchi Bill PR office started using #righttotry as a Twitter hashtag any doubt that the two campaigns were not related evaporated. No matter how queasy some of the efforts of the Saatchi Bill’s ‘media partner’, the Daily Telegraph might make one at least we’ve been spared five year old Jordan  http://www.wthr.com/story/28029775/5-year-old-lobbies-lawmakers-for-right-to-try-bill so far.

But the reality of the Saatchi Bill is far more radical than anything the Goldwater Institute have dared to try. US ‘Right to Try’ laws have been restricted to terminally ill patients. While the Saatchi Bill PR team have insisted that their Bill is primarily about terminal patients (see http://medicalinnovationbill.co.uk/about-the-medical-innovation-bill/ brilliantly corrected here https://wanderingteacake.wordpress.com/the-saatchi-bill-2/how-saatchi-actually-work/ ) and have managed to shift almost all discussion to being about terminally ill patients the reality is, and it is admitted in small print, it applies to all patients, all doctors, all conditions.

So PR has shifted most of the discussion around this Bill to become, “if I was terminally ill would shouldn't I be allowed to try an untested drug? Er, because you might die in agony? And not ‘what if a patient goes to a doctor, is promised “innovative treatment” which will cure an ingrown toenail, loses a leg and then finds they can’t sue?’

A great deal of effort has gone into pointing out that the Saatchi Bill would open the door for quackery: perhaps rather than an unintended consequence of the Bill it is part of the deliberate plan. The supporters of alternative medicine are a noisy bunch, always willing to sign petitions and lobby MPs so winning their support would help the Bill – and there is a certain irony in fans of alternative medicine lobbying frantically for Big Pharma’s right to harm patients with untested drugs and face no consequences. The free market fundamentalists are keen on the ‘consumerisation’ of health. There’s big money to be made in supplements, vitamin pills and assorted quackery so caveat emptor and the ‘magic of the market’ will decide, not doctors and regulators, and Big Pharma will rake in the profits, especially with astroturfed “patient groups” demanding untested drugs at astronomic prices. “Capitalism can save lives” http://www.telegraph.co.uk/news/general-election-2015/11398870/Ed-Miliband-will-never-understand-that-capitalism-can-cure-cancer.html declares the Saatchi Bill’s media partner today in a typical headline.

The advocates of the Saatchi Bill claim it will stimulate medical innovation despite the fact that the overwhelming body of expert opinion is that fear of litigation does not currently inhibit progress. No substantial changes have been made to the Bill to accommodate legitimate criticism. What this suggests to me is that while promoting medical innovation is the stated purpose of the Bill the real intention is to create a free market in health, where the quack can compete on level terms with the expert oncologist and untested drugs can be used on all patients with them having no redress if they are maimed or killed. The Saatchi Bill is a fundamental challenge to evidence-based medicine, proposing instead a free market free for all where profit is all and patient safety ignored.