Last throw of the dice…?

Is the granting of new rights to desperate patients and their doctors in the Medical Innovations Bill a valiant attempt to save lives – or will it turn the NHS into an unethical guinea-pig farm?

Over the last few days I’ve heard a lot of talk about how difficult it is for people who have life-ending illnesses to get their hands on un-tested experimental medicines they hope might help them. The focus of the arguments is a Bill being shepherded through Parliament by a Tory Lord, now officially supported by Health Secretary Jeremy Hunt.

The original idea for legislating on a dying person’s right to get access to un-proven experimental drugs was championed by libertarians in the United States under the snappy and amusing title “the right to try”. In case you don’t get the joke – it’s a pro-life snipe at the idea that people undergoing huge and pointless suffering should have a “right to die”.

In America, the campaign has been nurtured and funded by an outfit called the Goldwater Institute which is named after the late Barry Goldwater, a rabidly right-wing and slightly famous conservative politician. The proposed England and Wales legislation has been drafted and championed by a slightly famous right-wing conservative politician called Maurice Saatchi. He’s a Lord – not an elected representative.

Now I know you don’t want to go in for guilt by association, and neither do I …. but, suffice to say that Saatchi has already demonstrated his commitment to the fight against cancer by making millions out of advertising cigarettes. Amongst older readers he will also be remembered for his part in the rise of Thatcherism. That’s why he’s a Lord.

In the US, the “right-to-try” movement is enjoying considerable success. Colorado passed legislation in May 2014 and two other States have already followed suit. The laws are interesting. In a nutshell, the American law allows doctors to give patients “Investigational products which have not been approved by the United States Food and Drug Administration” as long as:-

•  The doctor confirms that the patient is dying and that no approved treatments can help.
• The patient signs an informed consent form including an acceptance of all responsibility for any unwanted or negative effects.
• The drug company agrees to release the drug – BUT they cannot be forced to do this.
• The drug is paid for voluntarily by the drug company, the doctor/hospital, the patient or the patient’s insurer – BUT the patient’s insurer cannot be forced to pay for the treatment.
• The drug must have passed a “Phase 1” clinical trial.

The English version of the law (which is the Bill currently going through parliament) is very similar to this, but there are a couple of important differences. Whereas the American version talks about “investigational products” the English version talks about “medical innovations”. And, because of that difference, there is no particular requirement in the English version for the treatment, drug, device or procedure to have undergone a Phase 1 clinical trial.

But what has been added in its place is a section setting down specific steps a doctor must take if and when he/she is considering what the Bill calls “a responsible decision to depart from the existing range of accepted medical treatments for a condition”. (That’s the Bill’s description of innovation).

In particular, the doctor must:- “(a) obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment and (b) take full account of the views obtained ..in a way in which any responsible doctor would be expected to take account of such views.”

Interestingly and in spite of the fact that supporters of the Bill cite patient rights as their main driver, it includes the telling words: “where a doctor departs from the existing range of accepted medical treatments for a condition, it is for the doctor to decide whether to do so”.

People who side with the Bill have two reasons for doing so. They feel that a very sick person has the right to try and extend their life by any means necessary (within reason, I suppose – but they never say that!). They also feel that many lives are needlessly lost every year because of the bureaucracy and red tape of regulatory authorities. And being ‘libertarians’, the very words “regulatory” and “authority” make them a bit twitchy at the best of times. From that standpoint it looks as if faceless bureaucrats are stopping ordinary hard-working sick people from getting their hands on life-saving drugs and it’s time for the little guy to stand up to big government.

The more serious underpinning of the argument is an assertion that the advance of medical science is being impeded by a politically correct, risk-averse ethical establishment. The ‘right-to-try’ mindset enthusiastically embraces the idea that progress is dangerous – they hold that that’s what being human is all about!

People who side against the Bill draw on a different range of arguments. They recognise that the NHS is striving to consolidate the principles of “evidence-based medicine” and that the highly sophisticated methodologies found in clinical trials have been carefully developed for a reason. Un-tested drugs, they point out, are exactly that. Untested. A lot of these products in development could easily do more harm than good. The deathbed pleadings of a desperate patient wracked by pain wouldn’t normally be seen as best ethical practice in this context. People with life-ending illnesses deserve the best care available delivered with compassion and consideration. Encouraging them to clutch at potentially damaging straws is a cruel and unethical way to proceed. Given the desperation of many patients and their families, there is the danger that the Bill is a potential quack’s charter. In this context, it can be argued, regulation exists for a clear reason.

It’s also noteworthy that, although proponents often describe the plan in pro-patient jargon, the plans as they stand are very ‘doctor-led’. Indeed, the whole notion of giving experimental drugs to real sick people has the whiff of an attempt to allow arrogant scientists to get their hands on a steady supply of compliant and expendable human guinea pigs.

Foreseeing problems in this area, most of the Bill is devoted to a set of clauses protecting doctors from litigation. In contrast, there are few patient protections, except for a requirement for the doctor to mention the plan to another doctor. There’s no requirement for the first doctor to pay any attention to what the second one says. Patient benefit is not and cannot be demonstrated by the Bill’s supporters – it is merely assumed as being “self evident” because the whole proposal is couched in terms of patients being “denied” access to the latest drugs.

In terms of developing medical science, rather than being convinced by the “fast-track innovation is always good” argument, many researchers are worried that genuinely worthwhile scientific work will be ham-strung because patients with serious illnesses will demand the latest “wonder drugs” rather than agree to be randomized into properly constituted clinical trials.

A different argument can be started by asking who, in a cash-strapped NHS, is going to pay for these expensive shot-in-the-dark potions? Normal decision making processes of this kind are at least in theory based on weighing up the evidence of potential benefit against the costs of treatment. But that kind of calculus is by definition impossible where speculative drugs straight from the laboratory are concerned.

For what it’s worth, my view is that the tub-thumping populism underlying the Bill is exactly the kind of nonsense that passes for a health policy in the political vacuum of late-coalition space. It’s a classic smoke screen and it’s doing a pretty good job of diverting attention from and obscuring the real problems of healthcare in England – appalling inequalities in life chances, health experience and access to treatment, chronic lack of investment and funding, disgraceful understaffing and inadequate infrastructure.

I am also led to ask: why do the same people who so vociferously champion the right to take un-tested and potentially dangerous medicines stand so firmly against empowering the terminally ill to choose to end their lives with dignity?