Critics of the Medical Innovation Bill like to say that patients will be at risk from doctors trying out new treatments because they will somehow be protected from negligence claims.
This is wrong for two reasons. A patient will be safer under this bill than under current common law.
First, a doctor wishing to rely on the bill must obtain the views of at least one other qualified doctor experienced in the patient’s condition.
This must be done in advance of treatment. Under current law, a doctor does not need to consult with colleagues; there is no legal requirement to take account of, or even obtain, the views of other doctors.
Therefore, the Medical innovation Bill is a step forward for patient safety.
It has been argued by some that the necessity to obtain the views – while not requiring their full agreement – is also a danger. This is not so.
A doctor wishing to innovate under the bill could not ignore advice because no judge would find in favour of a doctor who proceeded with an innovation against the advice of colleagues.
The Bill obliges the innovating doctor not only to seek the views of others before treating the patient, it also obliges the doctor to obtain all the standard consents necessary under current law.
Hence, a doctor must do what he or she does now AND build consensus for his or her innovation as well.
Therefore, those who like the current innovation process will welcome the Medical Innovation Bill for adding an extra level of patient protection.
The 100 doctors who wrote to the Times rubbishing my medical innovation bill are the authentic voice of complacency. Let us help them to move on
Writes Lord Saatchi
How many of the 300,000 British citizens diagnosed with cancer this year will receive an innovative treatment?
The answer, according to the awesome House of Lords Library, is 5.6%. In other words, 94.4% of Britain’s cancer patients will receive only the standard procedure. In the endless repetition of a failed experiment, 165,000 of them will die. You would need a fleet of JCB’s biggest excavators to dig the mass grave for this year’s cancer dead.
This is why I proposed the medical innovation bill, which is now before parliament. If passed, it will allow doctors to try reasonable innovative treatments, so long as they have the agreement of the patient (or patient’s representative) and of a panel of medical specialists.
The bill has the support of No 10, the secretary of state for health, the UK chief medical officer, the government’s chief scientific adviser, the medical director of the NHS, Britain’s top judges and 20,000 respondents to the government’s public consultation on the bill. But it is opposed by 100 doctors, who wrote a letter to the Times this week [paywalled link] saying the bill is rubbish.
How I pity their patients.
Theirs is the authentic voice of complacency and self-satisfaction, as in one of their quotes: “It is time that people listened to the experts.” These doctors sound like Lady Ludlow in Elizabeth Gaskell’s novel Cranford. She objected to the education of poor people on the grounds that “it is becoming common for the lowest class to have some education … the proper order of the world will be undone.” The doctors may not have realised that the age of deference is over – not just in medicine but in politics and all walks of life.
The “Times 100” insist that the only method of scientific advance is the clinical trial. Perhaps they overlooked the view of the forefather of the randomised controlled trial, Sir Austin Bradford Hill, who said: “Any belief that the controlled trial is the only way [to study therapeutic efficacy] would mean not that the pendulum had swung too far, but that it had come right off its hook”. Or maybe they missed the view of Professor Sir John Bell, regius professor of medicine at Oxford, who says there will be no cure for cancer “until real doctors with real patients in real hospitals can attempt an innovation”.
What sort of people do these 100 people think we are? Are we downstairs in Downton? Are we supposed to doff our cloth caps as these doctors go past us in Harley Street in their horse-drawn carriages?
They are living in another era. Our iPads can follow the proceedings of the American Society of Clinical Oncology conference in Melbourne at the same time as they do.
Let us help them to move on. In the modern era, any half-decent protest movement such as theirs needs a logo. They say a picture tells a thousand words, so here is their picture – a shrug of the shoulders.
They need a good simple “narrative” that gets to the essence of what they are saying. Here it is: “Save the status quo!”
That slogan will look good on a poster. Let them put it up in Britain’s hospices, where 80% of the patients – with a life expectancy of two weeks – are dying of cancer.
The Medical Innovation Bill applies to all areas of medicine.
However as defined in the Bill a doctor cannot give any treatment without patient consent and the Bill does not change the law on what treatments may and may not be given to patients without consent.
So if a patient were detained under section 2 or 3 of the Mental Health Act, and thus being detained and treated without consent a doctor would not be able to give innovative treatment without consent.
The Bill does not change the law about what treatment can or should be given to persons suffering from mental illness (in particular, the issue of “appropriate” medical treatment under section 3(4) of the MHA 1983).
So the Bill could apply to determine whether a decision to exercise a discretion to depart from standard practice in the treatment of mental illness was negligent: but it does not determine whether the doctor has a discretion in the first place, in terms of the law applying to mental illness.
The Bill also expressly does not change the law as to the need for consents, as to which there are of course particular considerations in relation to mental illness.
The Bill expressly limits itself to treatment that in the opinion of the doctor, having consulted appropriately qualified colleagues, is in the best interests of the patient himself or herself: so there is no question of the Bill being relied upon to use patients suffering from mental illness as opportunities to experiment for the purpose of scientific research.
The provision of treatment will have to be justified, exactly as in the case of non-innovative treatment, both in terms of the risk-benefit analysis for the patient and in terms of the laws addressing the provision of treatment to those suffering from mental illness.
Lord Saatchi’s Medical Innovation Bill completed its committee stage in the House of Lords last Friday. It has government support and so may become law before the end of this parliament next May. The bill could have a positive effect — though not as substantial as its supporters claim — and it contains (or will contain, with further amendments) sufficient protections to prevent it causing harm. It therefore deserves lukewarm support. The bill says that its purpose is “to encourage responsible innovation in medical treatment”. It provides that it is not negligent for a doctor to depart from the existing range of accepted medical treatments if the decision to do so is taken “responsibly”.
For the purposes of taking a responsible decision, the doctor must, in particular, obtain and take account of the views of one or more appropriately qualified doctors in relation to the proposed treatment, and consider the risks and benefits of that treatment, having regard to other available options.
This adds very little to the existing law. The common law test was stated by Mr Justice McNair in the Bolam case in 1957. A doctor is not guilty of negligence “if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”. In the Sidaway case in 1985, Lord Diplock emphasised that because the state of medical knowledge is not, and should not be, stagnant, the Bolam test does not require the doctor to follow the most orthodox approach: “there may be a number of different practices” that satisfy the test at any particular time.
The courts apply the Bolam criteria in a liberal manner in the interests of patients. Typical is the Judgment of Dame Elizabeth Butler-Sloss, as president of the family division, in the Simms case in 2002: she approved innovative treatment for two incapacitated patients suffering from brain disease. The treatment was “untried” with “no validation of the experimental work done in Japan”. But, she noted, there was responsible medical opinion in favour of trying the treatment. As she explained, the Bolam test should not be applied in such a way that “no innovative work such as the use of penicillin or performing heart transplant surgery would ever be attempted”.
In practice, doctors do already innovate in the interests of their patients, as Lords Winston and Turnberg, with their decades of medical experience, explained during the committee stage debate.
Lord Saatchi believes that the fear of litigation is holding back innovation in the treatment of cancer and other diseases and so a new statute would have a positive effect. But there is little evidence to suggest that the law, rather than lack of funding or excessive bureaucracy, is currently a problem in this context.
So this bill is itself not much of an innovation. Its main effect, as Earl Howe, the health minister, explained last Friday, would be to “bring forward the Bolam test to before treatment is carried out”, while preserving the common law rule for doctors who do not follow the procedures in the bill.
It is possible, though unlikely, that these new provisions will make a difference by encouraging otherwise timid doctors to innovate. It is a legitimate OBJECT of legislation to promote innovation, which is desperately needed in combating cancer. Parliament does not subscribe to the views of Sam Goldwyn, the film producer (as expressed in a pre-Twitter age): “messages should be delivered by Western Union”.
The crucial question, then, is whether the bill will offend against the basic principle of medical ethics recognised by Florence Nightingale as “the first requirement in a hospital”: it “should do the sick no harm”. The bill only applies to “responsible” innovation, which the law confines to reasonable treatment backed by a body of medical opinion. This excludes quacks. But there are important questions still to be decided at report stage.
At present, the bill applies to all medical treatment. But should the law be encouraging innovation in, for example, cosmetic surgery? A way forward would be to empower the secretary of state to prescribe excluded areas of treatment. A further defect is that the bill currently contains no requirement that those carrying out innovative treatment must record it on the patient’s notes or in a public register.
If we are to learn from the success, and more often regrettable failures, of medical trials, information needs to be recorded and shared. A third concern is that a bill which is said to be necessary to provide legal certainty for doctors in the interests of patients contains no provision safeguarding doctors who decline to innovate. The bill needs to state that a doctor is not obliged to innovate if he or she considers that to be contrary to the best interests of the patient.
The author is a practising barrister at Blackstone Chambers in the Temple, a Fellow of All Souls College, Oxford, and a crossbench peer in the House of Lords.
Ovarian Cancer kills too many women – pass the medical innovation bill
SIR – The Medical Innovation Bill reaches a crucial committee stage in the House of Lords today. Spearheaded by Lord Saatchi, whose wife died of ovarian cancer – a disease he quite rightly describes as “relentless, remorseless, merciless” – the Bill will make it easier for dying patients to access untested drugs and treatments.
The statistics for ovarian cancer are woeful: the number of deaths has barely changed in 30 years. So, unquestionably, something needs to change dramatically.
Innovation in treatment is important, but with gynaecological cancers it is innovative research into risk prediction, prevention and earlier detection that is going to make the most difference and save more women’s lives.
The statistics for cervical cancer are astounding by comparison: there has been a 70 per cent decrease in deaths over the same 30-year period thanks to advances in screening.
Investing in finding a cure for cancer is important, but we shouldn’t ignore investing in earlier detection.
It is hard, when confronted with pictures and reports detailing the Ebola outbreak in Africa, not to shake one’s head in pity. What medical facilities there are, we hear, are overwhelmed by the scale of it. So it is extraordinary to learn that Liberians dying of Ebola have better access to groundbreaking, potentially life-saving new treatments than do people dying of cancer here in Britain.
The Ebola treatment in question is ZMapp, an experimental serum which has not been tested on humans in medical trials, but was none the less given to two American doctors – Kent Brantly and Nancy Writebol – who were infected while working in Liberia. Both have now made a full recovery. Three infected African medics who have received ZMapp in Liberia are also reportedly doing well. Now a British doctor, infected with Ebola while working in Sierra Leone, is to be returned to this country for treatment at the Royal Free Hospital in north London.
The reason that such patients are able to receive ZMapp is because an ethics panel at the World Health Organisation has decided that, given the magnitude of the Ebola outbreak, a departure from standard evidence-based treatments is justified. Potential treatments that have shown promising results in the laboratory but have not been evaluated for safety and efficacy in humans are, in certain conditions, now acceptable on both ethical and evidential grounds, the WHO says.
Few doubt that the gravity of this outbreak of Ebola, which has killed about 1,500 so far, requires a response by all means necessary. Yet in Britain today the toll of another disease – cancer – is 100 times higher, and access to such experimental treatments is not available, even for those desperate patients beyond the help of current medicine.
Some 150,000 British citizens will die from cancer this year, making it the number one cause of untimely death. And while the disease may have a different name, our response should be the same as with Ebola – doctors should be encouraged to try new treatments, and be protected when they do so. Importantly, the Medical Innovation Bill, now before Parliament, will allow doctors and their patients in Britain to try treatments that have not been tested or fully trialled.
Inevitably, there are objections that the Bill’s restrictions and conditions placed on doctors are too lax – that they can play fast and loose with vulnerable, dying patients. So it’s worth looking at the conditions imposed by the WHO on ZMapp to see how they compare with the conditions set in the Medical Innovation Bill.
First: lethality. On Ebola, the WHO panel agreed that the threat posed by Ebola, with its “high case-fatality rate” was sufficient to warrant the use of experimental therapies. The Medical Innovation Bill is explicitly designed to achieve the very same result. This is why the Health Secretary, Jeremy Hunt, said about the Bill that “the Government should do whatever is needed to remove barriers that prevent innovation which can save and improve lives. We must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment.” The Secretary of State wisely asked Sir Bruce Keogh, the medical director of the NHS, to devise the legislative safeguards to be included in the Bill.
Secondly, ethics: the WHO rightly sets a high ethical standard for use of ZMapp, including “transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community”. The Bill echoes this ethical standard, requiring informed consent of the patient, or the patient’s representative, and full transparency. Indeed, the Bill goes further than the WHO guidelines, stating that in order to depart from the existing range of accepted medical treatments, a doctor must also obtain the views of at least one other relevantly qualified doctor, carry out a full risk assessment, and obtain any other consents required by law.
And, of course, while the WHO offers guidelines, the Medical Innovation Bill is backed by the full force of the law.
Finally, WHO guidance requires that all data generated by the use of ZMapp should be collected and shared. If scientific progress is to be made through such experimental use of untested treatments, results must be available to the scientific community. The Bill will secure this. The University of Oxford has offered to create a database to register innovative medical interventions under the Bill and to collect and share the data from them, so that they may inform and inspire clinical trials. As Sir John Bell, Regis Professor of Medicine at Oxford, said: “There will be no cure for cancer until real doctors with real patients in real hospitals are allowed to innovate.”
So those of us who have cheered the use of an untested drug to help apparently hopeless cases in Liberia should cheer the Medical Innovation Bill. It will help medical science progress, aid researchers in their hunt for cures for fatal diseases – and offer hope to the 300,000 Britons who will be diagnosed with cancer this year.
A new law to allow patients to try untested medicines will protect them and nurture medical innovation, a coalition of some of the UK’s most senior health experts say.
More than 40 medical professionals, including Prof Michael Rawlins – President of the Royal Society of Medicine and formerly a head of National Institute for Clinical Excellent, back the Medical Innovation Bill in a letter to The Telegraph.
The Bill, which will be debated by peers, will make it easier for doctors to try out new treatments on patients without the fear of being sued.
Patients will also be able to look up new medicines tried out on other ill people on a new database run by Oxford University and ask their doctors for the same treatments.
The Bill is being promoted by Lord Saatchi, the advertising magnate who started to campaign on the issue after his wife Josephine Hart died from ovarian cancer.
Leading experts who have signed the letter including David Walker, Professor of Paediatric Oncology at Nottingham University, and Riccardo Audisio, President of the Association for Cancer Surgery.
Several cancer patients signed the letter, along with Charlie Chan, a consultant general surgeon and Michael Ellis, Conservative MP for Northampton North.
In the letter – published to coincide with the second reading of the Bill in the House of Lords – the group said the Bill “legally protects doctors who try out innovative new techniques or drugs on patients when all else has failed.
“This Bill will protect the patient and nurture the innovator. It will encourage safe medical advancement, while at the same time deterring the maverick, thereby recalibrating the culture of defensive medicine.
“Finally, it will work with evidence-based medicine and provide new data that will inspire and support new research.”
The Bill was designed to give the hope to the dying but has since been amended so that untried drugs can be given to those who might benefit.
Oxford University has also agreed to set up and run a database containing anonymised information about those who agree to the treatments.
Stephen Kennedy, a professor of reproductive medicine at Oxford University, told The Telegraph the database will be “publicly accessible to patients and healthcare professionals alike”.
Patients would be able to go onto the website, find an innovative treatment that had been tested on other people and then ask for it to be tested on them.
Prof Kennedy said: “There would be a facility within the database to enable people to search on the basis of conditions and treatments.” Patients’ details on the site “would be completely anonymous,” he added.
The new law has been criticised by patients’ groups and lawyers. The Patients’ Association said it was concerned that drugs which have only been tried on a few hundred people could put patients at risk.
It was also worried about the issue of patients giving informed consent – especially if very ill patients are desperate for any chance of hope.
Katherine Murphy, the association’s chief executive, said it was possible “some gung-ho doctors will want to use dying patients as guinea pigs”.
She said: “The Bill is a huge threat to patient safety. It is aimed at solving a problem that doesn’t exist. We applaud and encourage medical innovation, but giving untested drugs to critically ill people is not the way forward.”
Jonathan Wheeler, vice-president of the Association of Personal Injury Lawyers, added: “This Bill allows a doctor to ‘play God’ with no consequences”
He said the Bill “would only require doctors to ‘consult’ colleagues about an innovative treatment. There is no obligation to gain the consent of those colleagues before going ahead”.
Lord Mackay, former Lord Advocate and Lord Chancellor, ‘I believe the Bill has the best possible protection…’
The new draft of the Medical Innovation Bill, which has its second reading in the House of Lords on June 27th 2014, is a strong and robust version of the Bill that has been improved by public consultation.
As the discussion continues in the public domain and, of course now in Parliament, the Bill will continue to be tested and improved by the dialectic of debate.
Indeed, the Bill Team has heard and reacted to the call for an open database to register innovations that take place under the Bill.
This will have two results. First, it will allow clinicians to see what innovations have already been tried, which will help drive new data, support the gold standard of evidence-based medicine and provide evidence which can be fully tested in clinical trials.
Second, it will act as another safeguard. A doctor who wishes to innovate, under the Bill, will be obliged to register that innovation in advance for all to see.
The Department of Health also commissioned NHS chief Sir Bruce Keogh to formulate a practical proposal as to how the Bill’s safeguarding mechanism should work, which he has done.
At the same time, criticisms of the Bill are crystallising. One objection asserts it is not true that the Bill needs the clear consensus of support from a body of relevantly qualified medical experts.
This critical assertion is false.
The wording in the Bill – in clause 1(3)a is legally tight. It states that a clinician must, as part of the process to assure protection under the Bill, consult ‘…with appropriately qualified colleagues…’.
The clear requirement to consult is a legal definition and has a meaning within the legal sphere that differs from its common linguistic use. It is a definition derived from case law (see below example)[i].
It does not allow a doctor merely to consult colleagues (in the everyday sense of the word) and then to ignore their advice. It means that a doctor must genuinely carry the meeting with him or her in order for the doctor to derive protection under the Bill. Arguments for and against must be minuted and documented.
As both a former Lord Advocate & Lord Chancellor James MacKay put it in the House of Lords second reading debate (on June 27 2014) The Bill sets out a procedure by which an innovation must be done “….by a process which is accountable, transparent and allows for full consideration of all the relevant matters, says Lord MacKay.
“The first requirement is, ‘consultation with appropriately qualified colleagues, including any relevant multi-disciplinary team.’
“That implies consultation. I have read some opinions which suggest that it could be ignored without any consequences whatever. You can ask someone’s opinion, and if it goes against what you want to do, you just ignore it and carry on.
“That is not my understanding of the term “consultation” as it is used in the law. Consultation means that you have regard to the opinion.
“…and of course consultation would include looking at the relevant literature on the subject.”
In short there is a clear requirement to attempt to build consensus; and a doctor who cannot demonstrate consensus will not able to rely on the protection of the Bill.
To state otherwise is incorrect.
Those that insist this is not so misunderstand the law.
However, lest there be doubt, it is worth applying the Occam’s razor test. To the question: is the Medical Innovation Bill, as stated in the intention clause of the Bill, designed to ‘…encourage responsible innovation in medical treatment and to deter reckless departure from standard practice’?
Or, conversely, is it an incredibly complicated, deep, dark, cunning artifice and a conspiracy to in fact do the opposite of what the Bill actually says and to allow quackery and destroy empirical science?
[i] See, for example: R v Brent London Borough Council, ex parte Gunning (1985) 84 LGR 168 ; R v North and East Devon Health Authority, ex parte Coughlan [2001] QB 213, [108].” (R. (on the application of Compton) v Wiltshire Primary Care Trust [2009] EWHC 1824 (Admin) at para.104.); Agricultural, Horticultural and Forestry Industry Training Board v Aylesbury Mushrooms [1972] 1 W.L.R. 190 per Donaldson J.).
People who receive a cancer diagnosis suffer a fate worse than death by firing squad, a Conservative peer said yesterday, as he called for doctors to be granted the freedom to try out new treatments on patients.
Lord Saatchi, the advertising guru, said that execution methods such as hanging and the electric chair were less harrowing than wasting away with cancer. “Death by hanging, by firing squad, by electric chair: no human being has devised a more brutal execution than death by cancer,” he said.
“These cancer-condemned suffer a worse fate than the worst mass murderer. While they await execution they are tortured. For them, hair loss is the good news. Less good news is their treatment regime. The drugs, the cycles of their administration, the surgical procedures are often 40 years old.”
Lord Saatchi argued that the law acts as an impediment to finding a cure for the disease. He has introduced a bill that aims to give legal protection to doctors who experiment with different procedures or treatments when all other options have been exhausted.
Under present legislation, he said, doctors worried that they could be found guilty of medical negligence if they deviated from “standard procedure”.
Introducing the second reading of his Medical Innovation Bill in the House of Lords, he said that the proposals would lift the fears from doctors’ shoulders by defining “responsible innovation” and setting out a framework for them to find new cures. They would have to consult colleagues and discuss the options with patients, he said.
The peer has been campaigning for changes to the law since the death of his wife, Josephine Hart, the novelist, from ovarian cancer in 2011. More than 40 medical professionals have backed his idea.
Earl Howe, the health minister, said that there was a delicate balance between encouraging innovation and ensuring patient safety, but said the latter should not stifle the former.
The government has suggested some amendments to the bill to strengthen oversight. Lord Saatchi said that he would adopt these suggestions.
Teen Cancer America and why Executive Director supports the Saatchi Bill
My support for the Medical Innovation Bill began at its inception when I was CEO of Teenage Cancer Trust and Chairman of Cancer 52 in the UK in 2013.
Now I am Executive Director of Teen Cancer America and still support it because it has the potential for global impact that will benefit patients here in America and around the world. There is no doubt in my mind that it’s ripple (or wave) effect will be of transatlantic proportions.
The cancers that affect young people are rare and difficult to treat. Research into rare cancers has lagged far behind due to lack of investment and innovation. For teenagers they are further discriminated against because regulatory systems designed to protect small children prevent their access to adult clinical trials when there is no medical reason why they could not benefit.
So one of society’s most precious commodities has least access to life saving treatments. No surprise then, that survival in some of the rare cancers they get is still shockingly poor and has seen little improvement in over 30 years.
The Saatchi Bill will at least swing the pendulum back in the direction of Doctor/patient partnerships. Doctors facing few options for desperate and dying patients will, with their consent and collective peer approval, be able to try out new therapies without fear of criticism or legal challenge.
Patients will have more influence, as they always should have done and we will learn more with every new trial.
I’m pleased to see the Bill’s latest drafts with some wrinkles removed. Safeguards are in place to protect against Burzynski style exploitation and there will be transparent collection of outcome data for all to see and learn from.
There may be commercial challenges for industry who could lose some control but it’s no bad thing and at least it will be a level playing field. This is a moment in time for them to realize that this is just the right thing to do.
Like the minimum wage or disability rights, there are times when the benefit to society outweighs commercial gain or governmental control and we just need to improve our human profile one more notch. So put down the rattling sabers and let this piece of medical history take its course.
The people have spoken, the consultation consensus was overwhelmingly in support and politicians must now fulfill their obligation to represent their constituents wishes in the best interests of us all.
When all is said and done, the one unifying fact is that regardless of any other status or position we might hold, every one of us is a patient and could benefit from this Bill.
This one is for you, your family and your friends. Don’t let us down. Support it.
The Medical Innovation Bill will help doctors to innovate new treatments and cures safely and responsibly for cancer and other diseases.
