I want to discuss medical innovation. But, to begin, I'd like to take you to a couple of small islands in the South Atlantic, 8,000 miles from the UK.
It's July 1992 and I am standing on Mount Longdon in the Falkland Islands, on a bitterly cold and dismal winter day. On my six-month tour of duty, the Falklands was a very different place from what it had been during the seven-week conflict a decade earlier. But my guide on Longdon that day was a Staff Sergeant, Royal Engineers, who had been in the battle for the strategic high ground. Attached to 3 Para, his account of the realities of battle were visceral and haunting; his description of injuries to colleagues, vivid. It was harsh and medical care on the mountain was basic, with definitive treatment provided by a field hospital set up in farm buildings in Ajax Bay. I wondered at the time how anyone with significant battle injury survived.
The 'red and green life machine', as it was christened, was the field hospital at Ajax Bay commanded by the charismatic Royal Navy medical officer, Rick Jolly. His primary aim was to ensure that anyone who had survived long enough to reach them would not die of their injuries. In part, the eventual success of the treatment of casualties admitted to the field hospital was due to a simple, improvised and innovative resuscitation policy that was later described in the BMJ1. The authors noted that the standardisation of the procedure and elimination of choice for fluids and drugs 'contributed greatly to the speed of [the] treatment'.
Necessity is an obvious driver of innovation. In a conflict zone doctors have to make do with what is available, and use it wisely.
Necessity is an obvious driver of innovation. In a conflict zone doctors have to make do with what is available, and use it wisely. Britain isn't a war zone and when doctors want to innovate in hospitals and surgeries they generally do so using the rigorous safeguards and comprehensive analyses that accompany clinical research protocols. When a new drug or treatment is made available it is reassuring to know that it has been tested in a safe way, using ethical procedures and where a lot is known about its effectiveness and potential adverse effects.
Is there a need for legislation to empower doctors and others to innovate in medicine? The MDU doesn't think so. Currently the Access to Medical Treatments (Innovation) Bill 2015 is making its way through Parliament. It has two aims - to create a database of innovative treatments and to provide a statutory defence of 'responsible innovation'. These aims, though well-intentioned, are unnecessary and the Bill is founded on the premise that doctors are put off innovating by the fear of litigation. We have seen no reliable evidence this is the case, and the MDU's experience is that we have never known a doctor to be sued just for innovating.
Innovation is alive and well
The example of innovation in military medicine stems from personal experience and interest, but it is not something that is unique to the battlefield. It will be obvious to any MDU members reading this article that innovation is alive and well in the NHS - you may even have personal experience of using an innovative approach in treating a patient. There may have been something in the circumstances of a particular case that demanded a new approach, and the chances are that after a full discussion with the patient you got on with doing what was necessary. It will be no surprise if I tell you we often advise members from all specialties about the implications of trying an innovative or experimental treatment. Our consistent advice is that there should be no reason to fear the consequences of innovating, provided:
- appropriate safeguards are in place to ensure patient safety
- the patient fully understands what is proposed and why the doctor considers the treatment is in the patient's best interests
- the patient consents.
For consent to be informed the patient needs to be told about material risks. The Supreme Court2 has said that material risks are those that a reasonable person would be likely to attach significance to, or that a doctor is (or should be) reasonably aware that the particular patient would be likely to attach significance to. This is not new, and does not need legislation to reinforce the principle. The need to have discussions with patients to ensure they make informed choices about their treatment has been a part of GMC guidance on consent since 19983.
Why the fuss, you may well think. What harm could a medical innovation Bill do? The answer is quite a lot, and is partly to do with unintended consequences. An obvious risk is delay. Currently, where a doctor believes innovative treatment is necessary and in the patient's best interests they can proceed as long as appropriate safeguards are in place and there is fully-informed consent. But the 2015 Bill requires that a doctor:
- obtains the views of one or more appropriately qualified doctors in relation to the proposed medical treatment, with a view to ascertaining whether the treatment would have the support of a responsible body of medical opinion
- takes full account of any such views expressed in a way that any responsible doctor would be expected to take them into account
- obtains informed consent required by law for the treatment
- takes such other steps as are necessary to secure that the decision is taken in such a way that it is accountable and transparent.
- records all the steps taken to obtain the appropriately qualified colleagues' views and the reasons for the doctor's decision to depart from standard treatment protocols.
The Bill states that a colleague (with whom the innovating doctor has discussed the proposed treatment) is 'appropriately qualified' if they have appropriate expertise and experience in dealing with the condition in question. If there is any degree of urgency, it may be difficult to find such expert and experienced colleagues. For some conditions, a national or even international search may be required to identify someone suitable.
Complex and unnecessary steps
It is difficult to see how additional complex and unnecessary steps in embarking on innovative treatment are likely to assist and reassure doctors, and it is even more difficult to see how it might genuinely assist patients gain access to innovative treatments. Conversely, it is all too easy to see how patients' hopes could be raised with little or no evidence of benefit, and where rigorous, statistical assessment of advances in treatments are replaced by occasional, anecdotal reports appearing in the database that the Bill proposes to establish.
Another unintended consequence of new legislation is its potential effect on clinical research. Most doctors assume that innovation is part and parcel of clinical research. It is, and this gives patients safeguards. In its response to the Access to Medical Treatments (Innovation) Bill the Academy of Medical Royal Colleges noted:
'Innovation cannot, and indeed should not, be separated from research - which is what the Bill does. There cannot be one system for research and another for innovation.'
I began by looking at innovative treatment born out of necessity during the Falklands conflict in 1982. Perhaps it is apt, therefore, to return to military medicine to conclude. A BBC report in 20114 found that innovation continues to flourish in the battlefield. The now-routine use of tourniquets issued to soldiers to prevent catastrophic blood loss before they can receive medical treatment and the deployment of expert medical, nursing and paramedic teams in aircraft which pick up patients close to battle lines are good examples. All these advances took place without the existence of legislation that is claimed to promote innovation.
It is right that doctors, both civilian and military, should continue to innovate safely and responsibly. It is wrong to suppose that a medical innovation Bill is necessary for them to do so.