From The Daily Telegraph 2 June 2014
By Nick Ross
Lord Saatchi has promoted a private Bill whose supporters have implied it might help to cure cancer. Unsurprisingly his idea has drawn a lot of approval from the public, and even from the Telegraph. After all, who could be against innovation in medicine?
Sadly the Bill is misnamed and misguided. It will not promote invention, it will not help cure cancer or any other disease and it could be harmful. Thankfully it is being substantially revised, but even so it could well set the clock back.
How is that possible?
The answer is that Lord Saatchi, though a grieving widower and a PR genius, is not a medical researcher, or even a scientist. He believes that doctors are held back from prescribing innovative treatments out of fear of litigation. Many have told him there is an “invisible red light” which holds them back. But it is a fantasy, and if some doctors misunderstand the facts they need to be better advised. Neither he nor his supporters can cite a single instance where legitimate research has been hampered in this way. Medical research faces too much red tape but it is not besieged by hyena lawyers. The NHS Litigation Authority says such claims are vanishingly rare. In fact clinical research accounts for only 0.01 per cent of NHSLA payments, and these were cases where recklessness was alleged. The biggest defence group in the world which defends doctors against litigation is the Medical Protection Society and it too opposes the Bill. It says bluntly it has “seen no evidence that a fear of clinical negligence claims is holding back medical innovation”.
It wouldn’t be so bad if the Bill was simply unnecessary, but as first drafted it was positively dangerous. It proposed to give clinicians legal immunity if they try new things out. But breakthroughs in medical research are made systematically, one step at a time involving scrupulous trials with ethical oversight and peer review. It would be reckless to return to the age freelance have-a-go heroes who experiment on their patients. This would undermine evidence-based medicine.
Until this week the Bill required that there must be “plausible reasons why the proposed treatment might be effective”. But it did not require scientifically plausible reasons. To quacks, faith healers, fools and conmen (and sadly even some qualified physicians) almost anything is plausible, including meridians, spirits, water memory and laying on of hands.
In any case, plausible theories can be, and have often proved to be, spectacularly and fatally misleading. Laying babies to sleep on their stomachs (so they don’t ingest vomit) was a plausible idea that resulted in thousands of cot deaths. Dozens of other half-baked ideas – giving oxygen to premature babies or steroids for brain injury – have taught how persuasively dangerous credible notions can be.
Maurice Saatchi invited me to discuss my concerns with him three months ago and graciously accepted that the Bill should be amended (a) to avoid opening the flood gates to quackery or to buccaneering experimentation on vulnerable patients; and (b) to provide for the essential importance of disseminating results.
Meanwhile, the magnificence of the Saatchi marketing machine has overshadowed the fact that bulk of the medical research community has since come out against the Bill including the NHS Health Research Authority, the Academy of Medical Royal Colleges, medical research charities such as Cancer Research UK, the General Medical Council, the Medical Protection Society, the British Pharmacological Society and senior lawyers like Robert Francis QC. [You can see a selection of the opponents here.]
To his great credit Maurice Saatchi has been listening. His new version is to be published on Thursday and it will embody fundamental changes. For a start it will specifically exclude research – the very thing it was touted to be liberating. And, thank heavens, it will now require consultation with appropriately qualified colleagues, including any relevant multidisciplinary team. Of course if appropriately qualified doctors and multi-disciplinary teams are all outside the scientific consensus, as is the case in dubious clinics in Switzerland and Mexico for example, even downright quackery would be covered by this clause. But above all the revised Bill is likely to retreat from its founding principle, which was to insulate doctors from common law. It will now specifically acknowledge that nothing in the Bill is intended to stop patients suing doctors for negligence.
In essence then, the revised Bill will simply allow doctors to do what they can do already, which is to try out last-ditch remedies. But there will be an advance. Although it is not yet in the one-and-a-half-page draft to be published this week, his staff have made me a “copper-bottomed” promise that Lord Saatchi will make further amendments to seek to collect results of all these desperate measures and will disseminate results.
Since more work is to be done maybe the Bill could yet be turned to much greater advantage. I have proposed to Lord Saatchi that he could rebalance the Bill to tackle the real problem of healthcare litigation. This is the 99.99 per cent of claims that have nothing to do with innovation but drain the health service of £2.25 billion a year, are of serious concern to clinicians, create a burden on legal aid and cause a great deal of personal distress. Claims against surgeons and physicians range from the spurious, sometimes whipped up to a froth by greedy lawyers, to the tragic, which damaged patients sometimes find hard to pursue; but all of them are hugely expensive and a big distraction. The legal costs can dwarf the actual damages awards and they very frequently deter health authorities from challenging questionable claims.
Claims should first go to mediation or arbitration with some right of appeal to an ombudsman. The ombudsman’s decision would be binding but in turn he or she could, if a case was thought to be particularly serious or of public importance, refer the matter to the courts.
There are good precedents for legally binding arbitration, and the ombudsman system is well-established and highly regarded. But in any case the principles of reconciliation and escalation would be a big advance on the damaging adversarial process we now have. And it could save the NHS a ten figure sum each year.
Meanwhile a Bill which promises to free us from unnecessary restraint, and is riding the surf of a brilliant publicity campaign, misses the big picture to solve a problem which is largely just one of perception.