Telegraph: Lord Saatchi Bill: We must liberate doctors to innovate

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Lord Saatchi urges the public to seize a ‘once in a lifetime’ opportunity to change how medicine is practised in British hospitals.


I don’t remember feeling anger when my wife, the novelist Josephine Hart, died in 2011 of ovarian cancer. I certainly didn’t want to thump anyone. It was a calamity, but grief is not a disqualification for rational thought.

I knew that no one had done anything wrong, or behaved badly, that the doctors who had treated Josephine were neither incompetent nor inefficient, that they did what they were supposed to do with drugs and chemotherapy. They followed “standard procedure”, even if the treatment was degrading, medieval and ineffective, and they knew it would lead to her death.

What puzzled me was how there could be such a ready acceptance in the medical profession of “standard procedure” in the light of the hundreds of thousands who die of cancer. In the case of advanced gynaecological cancers, such as my wife’s, “standard procedure” is 40 years old, offers poor quality of life, and the mortality rate is 100 per cent, with the survival rate correspondingly zero.

They did it, I came to understand, because “standard procedure” is the only safe route they can take legally. The patient, their family, their partners and their lovers may all be desperate for something else to be tried, something new, something innovatory, but the law prevents any innovation, however reasonably chosen and carefully managed. Why? Because it defines innovation as deviation from “standard procedure”, and deviation makes it medical negligence.

In 2012, the NHS paid out £1.2 billion as a result of medical negligence claims, that figure had doubled in four years. And Treasury figures show that we have a pot of £24 billion set aside to cover future liabilities. That is a staggering sum, roughly half of the defence budget. The result is that, if you are a doctor in a hospital, you are all too conscious of the tide of litigation, and you become risk averse. And innovation averse.

There may not have been anything to stop Josephine dying, but the terrible thought that haunts me is that her death was a wasted death. Indeed, all 165,000 cancer deaths in this country every year are wasted deaths because science advances not one centimetre as a result of them. Nothing new is tried and so nothing can be learnt that might spare others. Scientific progress is being halted by the law and fear of negligence bills.

This culture has to change. Last year I introduced a Private Member’s Bill into the House of Lords that set out a legal framework “to encourage responsible innovation in medical treatment and to deter reckless departure from standard practice”.

It was drawn up with the help of the best legal and medical minds, and stipulated that, to innovate, doctors must have patient consent and the agreement of other senior medical experts and practitioners. They cannot go it alone, but they can go beyond standard procedure without fear of ending up in court.

Such Bills usually stand little chance of success, but two things were in my favour. The first was the overwhelming tide of support I received from doctors, lawyers and, most of all, from those who wives, husbands, sons, daughters, brothers and sisters have died wasted deaths from cancer.

“I truly hope with all my heart,” one correspondent told me, “that your Bill is a success and it changes for the better the treatment offered to cancer sufferers in the UK. It drastically needs to change. My husband was belatedly diagnosed with pancreatic cancer in February 2007. We were told (mistakenly) it was inoperable and that chemo was the only option, not as a cure, just to buy him more time, before finally a different surgeon at a different hospital agreed to operate to remove the tumour, saying he could’ve done so at time of diagnosis. The op was too late and the cancer had spread to his lungs. My husband died.”

Or another, who wrote that “when discussing the benefits/disbenefits of certain treatments with my GP, he pointed out that if he did not follow the “guidelines” and something went wrong, he could be open to a legal suit”.

And the second was that, last November, Jeremy Hunt, the Health Secretary, with the backing of the Prime Minister, announced his “wholehearted support” for my proposals, and promised government support to legislate to make them happen, after a public consultation.

But this had to be, he stipulated, “a full and open consultation, a consultation that gets the views of patients on the right balance between innovation and safeguards, a consultation that hears from clinicians on the problems they face in innovating and how to overcome them”. He has even agreed that responses to the consultation – which must be received by May – can be sent to the Department of Health via social media.

Mr Hunt has laid down the challenge. I’m appealing to Daily Telegraph readers to join with me, and the tens of thousands who have already given me their support, to make this the biggest government consultation response ever. We need to say loudly and clearly we want to try new treatments for cancer where the old ones are known to lead only to death. We want to escape being doomed to repeat an endless cycle of failure.

What’s wrong, you may ask, with the way we explore new treatments for cancer now? Clinical trials, random clinical trials, take a long, long time to produce results. It can take 15 years and £1 billion to come up with just one drug. I believe passionately that we will get no closer to a cure for cancer until doctors can test new treatments, in a controlled way, not on laboratory animals but on real patients, with real illnesses in real hospitals.

I believe that we are on the brink of a great medical moment, a once-in-a-lifetime opportunity for a change of culture, away from being risk averse, and back to the spirit of medical innovation that once led Alexander Fleming to the discovery of penicillin or Sir Peter Mansfield to enable magnetic resonance imaging.

In this new culture, we will be able go to our doctors and say, “have you tried everything? I understand there is a treatment out there that might help. Can you try it on me? I have nothing to lose.” And the doctor, for the first time, will be able to say yes.

I can’t promise you that, by itself, this change will cure cancer, but it could encourage the person who is out there right now, who may still be a child, and who one day may free us from this blight on my life, and yours.

Curing leukaemia

IN THE 1940s, the survival rate for childhood blood cancers was pretty much zero. At the time, the scientific literature argued that anyone trying to cure childhood leukaemia was cruel, because the result was always the same: death.

Prolonging the agony with needless, unproven medical interventions was wrong, it was argued; the condemned child should be made as comfortable as possible and allowed to waste away.

A few determined doctors in the United States and Europe challenged this defeatist sentiment. They tried treating the disease with folate, a B vitamin, and discovered that it got worse.

As a result, they tried drugs which reduced folate levels instead. This worked and led to the introduction of the still-used drug methotrexate.

Andy Hall, Professor of Experimental Haematology at the University of Newcastle upon Tyne, says: “What those doctors did then couldn’t be done so quickly now.

“Those doctors were close to the patients dying on the ward and not prepared to accept the status quo. Survival rates for children with leukaemia today are around 90 per cent.”

‘Off-label’ drugs

DEVIATING from the standard medical procedure can offer hope to those with the most dire prognoses — which is why Prof Angus Dalgleish, Professor of Oncology at the University of London and the Principal of the Cancer Vaccine Institute, is a supporter of the Saatchi Bill. He feels doctors are too often afraid to try new ideas, by prescribing drugs “off label” — for diseases for which they have not been licensed. “I have recommended logical, non-standard treatments to cancer patients who have run out of standard options,” he says. “I have seen on many occasions patients who have benefited dramatically.”

One example was a 63-year-old man with metastatic prostate cancer for whom the usual treatments were not working. “We agreed that he try a drug licensed at a high dose for another condition. Even though his other doctors thought his case was terminal, he had a marked clinical response and survived for another three years, dying not from his disease but due to the indirect chronic effects of his previous therapies.”

How war promoted modern surgery

War is a crucible for medical innovation. Medics are faced with men and women who are dying, often in large numbers and are driven to try new techniques, sometimes developed in the heat of battle. They have little to lose and all to gain – saving otherwise doomed soldiers from death.

In the Falklands war of 1982, Surgeon-Captain Rick Jolly OBE – a man decorated both by the British and the Argentinians for saving lives on both sides – operated in a field hospital with an undetonated bomb lodged near his operating table. He discovered that casualties left out in the cold because it was impossible to collect them from the battlefield fared well, in many cases, leading to the development of theory of therapeutic hypothermia, whereby patients can benefit from deliberate cooling.

Penicillin was first used in earnest in the Second World War. Doctors were aware of its benefits, but not necessarily how to use it and in what doses. However, knowing that personnel would likely die without it, doctors administered it, learning as they went. Military doctors facing injury and suffering on a massive scale during the Second World War also pioneered advances in antibiotics, anaesthesia and blood transfusions – advances that would usher in the age of modern surgery.

The innovating breast cancer surgeon

GEOFFREY Keynes could arguably be considered the patron saint of innovation. In 1922, the surgeon, based at Barts Hospital in London, developed the lumpectomy for breast cancer, flying in the face of orthodoxy. Back then, the accepted practice for dealing with breast cancer, developed by the all-powerful American surgeon William Halsted was the radical mastectomy. The “Halsted Procedure” was a physically deforming operation involving removal of the breast tissue, skin, nipple, axillary lymph nodes and the underlying chest wall muscles.

Keynes, the brother of economist John Maynard, began using removal of the tumour and radiation therapy to treat breast cancer. More than 70 per cent of his patients survived five years, a rate that was similar to that in patients who underwent the Halsted operation, yet without the massive, debilitating surgery.

For his pains, Keynes was ridiculed — yet lumpectomy was gradually accepted as a standard treatment, with the Halsted operation rarely performed today.

The future?

How might the Saatchi Bill work in practice: a hypothetical case study.

Doctor Glenda Smith is treating a patient, Alison Jones, for a rare and life-threatening condition. She asks Dr Smith about a new kind of non-surgical treatment she has read about. Dr Smith discovers the new treatment has not been tested for Alison’s condition, although it has been used for other illnesses.

Under the present legal conditions, Dr Smith will feel safest to say that in the absence of published research, she cannot advise anything departing from the standard surgical procedure. If she innovates and Alison dies earlier than would be expected statistically with standard treatment, she will be vulnerable to disciplinary or legal proceedings.

Under the Bill, if Dr Smith was impressed by the arguments in favour of the new treatment, she could follow the process outlined in the Bill, which includes talking to other experts and to Alison and her relatives about the innovative treatment, and obtaining a consensus as to its use.

If the case came to court, Dr Smith could be confident she had followed the Bill’s processes and any court decision would be made in that light. There would be no opposing ranks of “experts” commissioned by the two opposing legal sides, after the event.

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