All posts by Medical Innovation Bill

The Access to Medical Treatments (Innovation) Bill

Lord Saatchi has handed over the former Medical Innovation Bill to Chris Heaton-Harris, MP for Daventry.

Mr Heaton-Harris will be taking a new version of the Bill through Parliament as his own, private member’s bill.

He has renamed it the The Access to Medical Treatments (Innovation) Bill. This Bill is inspired by elements of the former Medical Innovation Bill.

However, it is not the same Bill.

It is likely to contain significant differences and it will be amended as it proceeds through Parliament.

Lord Saatchi has not been part of the process of drafting the new Bill. However, if asked to shepherd the Bill through the Lords, Lord Saatchi will do so.

The Access to Medical Treatments (Innovation) Bill has its second reading in the House of Commons on 16th October 2015 and we ask that you lend it your support.

Chris Heaton-Harris writes:

“The second reading of my Private Member’s Bill, Access to Medical Treatments (Innovation) Bill, will be taking place in the House on the 16th October 2015.

“I am writing to ask to you to help me get my Bill through this stage by contacting your local MP and requesting their attendance and support.”

“My Bill’s influence is derived from Lord Saatchi’s Medical Innovation Bill, which was introduced in the House of Lords during the last Parliament.

“The terrible loss that Lord Saatchi suffered inspired his own Bill, the central idea of which I most fully support – that being to encourage doctors to pursue responsible innovation in medical treatment.”

More detail on the new Bill

“My Bill has quite clearly departed from the Medical Innovation Bill, and now seeks to promote access to innovative medical treatments in two key ways,” continues Chris Heaton-Harris.

“(1) by giving the permissive power to the Secretary of State for Health to create a database of medically innovative treatments.

“The database will give doctors a source of information on medical innovations, providing an evidence base and sharing platform for innovation.

“It will also increase transparency in innovative treatment decisions by recording the treatment and its outcomes. Centrally, this includes both successes and failures.

” And 2) to encourage responsible innovation by alleviating confusion and confirming in legislation that a doctor will not be negligent when departing from standard practice, if they have acted responsibly.

“The Bill sets out a series of steps that doctors can take to evidence that they have acted responsibly, including seeking support from a ‘responsible body’ of medical opinion, thus reflecting the current common law Bolam test as closely as possible.

“The Bill does not replace the common law test, but does provide a way for doctors to evidence they have acted responsibly when innovating, prior to the point of treatment, increasing a doctors confidence to suggest an innovative treatment.

READ the Access to Medical Treatments (Innovation) Bill on its parliamentary page.

I would be grateful if you could share with me any examples you have of a time when medical innovation has been hampered by a lack of data sharing, or when the above database and / or negligence clause would have been helpful.

Thank you,

Chris Heaton-Harris

Lord Saatchi has handed over the former Medical Innovation Bill to Chris Heaton-Harris MP.

Mr Heaton-Harris will be taking a new version of the Bill through Parliament as his own, private member’s bill. He has renamed it the, ‘The Access to Medical Treatments (Innovation) Bill’.

This bill is inspired by elements of the former Medical Innovation Bill. However, it is not the same Bill. It is likely to contain significant differences and  and it will be amended as it proceeds through Parliament. The new bill is supported by the government.

Lord Saatchi has not been part of the process of drafting the new Bill. However, if the government asks him to shepherd the Bill through the Lords, Lord Saatchi will do so.

The Bill is introduced into the House of Commons

The Medical Innovation Bill has today been introduced into the House of Commons as a Private Member’s Bill by Chris Heaton-Harris MP.

This is now his Bill and already he has changed the title to: “Access to Medical Treatments (Innovation) Bill”.

Lord Saatchi said: “It is wonderful news for patients that the bill has moved forward to the next stage. The House of Commons will bring great expertise to the scrutiny of the bill.”​

Here’s how we got to today.

The Bill was taken through the House of Lords by Lord Saatchi, supported by the government health minister in the Lords, Earl Howe.

It was debated, amended and passed by the Lords and handed over to the House of Commons for MPs to debate and amend.

However, it was halted before it got to the Commons by the then Liberal-Democrat health minister Norman Lamb. (He was able to do this under the coalition agreement the Lib-Dems had with the Tory leadership – allowing them to veto discussion of Bills in the Commons).

We then had the general election – so the Bill ran out of time.

Where are we now?

First of all, all the amendments made in the House of Lords, which won over the support of the Lords, remain.

Second, there is much more time available now for MPs to debate the Bill. We are not faced with a looming general election and we are at the beginning of the new Parliament. This means that MPs can debate and amend the Bill.

We know that government ministers support the Bill, as does Labour’s shadow health Minister Andy Burnham. So, it has a good chance.

But there is, as you know, genuine opposition from some medical bodies, including Royal Colleges and the BMA. Many have changed their positions over the past two years and we hope we can persuade them to change their minds back again to supporting the Bill, as it develops.

Lord Saatchi listened to his colleagues in the Lords and amended the Bill and now MPs will have their say – and through them, so will all those – patients, doctors and lawyers – who have an opinion.

This is democracy and we hope all will join the debate and make this Bill a success.

Andy Burnham says LibDems’ decision to axe Saatchi Bill is ‘odd and wrong’

Andy Burnham MP - Medical Innovation Bill
Andy Burnham MP – Medical Innovation Bill

By Christopher Hope

Published in the Telegraph 2nd March 2015

→READ: Telegraph: Andy Burnham says LibDems’ decision to axe Saatchi Bill is ‘odd and wrong’

The Liberal Democrats’ decision to stop MPs voting on a new law to allow doctors to test treatments on dying patients is “odd and wrong”, Labour has said.

The comments from Andy Burnham, the shadow health secretary, leave Nick Clegg’s party politically isolated over its controversial decision to withdraw support for the Medical Innovation Bill.

The Bill – which was passed by the House of Lords – would have allowed doctors to test cutting edge new treatments on patients to help find cures for cancer and other serious illnesses.

It was being promoted by Lord Saatchi, the advertising magnate after his wife Josephine Hart died from ovarian cancer.

However last week the LibDems’ health minister Norman Lamb said the party would not allow the Commons to debate it – effectively killing the legislation.

Mr Burnham criticised the decision as “strange” and said the LibDems should have entered talks with Labour and the Tories to iron out any concerns.

He told The Daily Telegraph: “I am disappointed that the Liberals have done this – there should at least have been some cross-party talks about this, at the very least.

“The Bill was heavily amended and extra safeguards put in, and I worry a little bit that those who are opposed to it don’t realise that it is actually quite a different Bill now.”

Mr Burnham said that the Bill had offered hope to desperate parents of seriously ill or dying children.

He said: “For parents like them nothing is available and they have no hope, it [the Bill] is about opening up hope.

“It is often parents who struggle to get their voice heard – they often don’t get much parliamentary time or much focus.

“Norman’s move is odd and wrong, because just to give it an airing would help get some focus on the awful position many of these parents find themselves in.”

Margaret Hodge, a senior Labour MP, said the Bill provided “clarity and certainty for patients and doctors at the point of treatment, and enable doctors to innovate confidently”.

Peers also expressed their anger on the floor of the House of Lords on Monday that the legislation had been effectively axed without a vote by MPs.

David Cameron, the Prime Minister who had supported the Bill, said Mr Clegg and the LibDems would have to defend their decision.

The Prime Minister’s official spokesman said: “The Prime Minister has expressed his support for this – there were changes that were made during its passage through the Lords, with regard to safeguards.

“He has argued for it to go ahead and those who have come to it differently will have to explain their position.”

→READ: How exactly did the Lib Dems kill the debate

Lord Saatchi described the LibDems’ decision was “a death sentence” for “cancer patients. It is an extraordinary turn of events.

“This is a grotesque insult to the House of Lords. The Liberal Democrats are saying that the House of Commons will never debate this Bill which has been sent to it and passed by the House of Lords.”

But defending the decision, Mr Lamb said: “The Liberal Democrats have listened to the concerns of patient organisations, research charities, legal bodies, royal colleges and medical unions who have told us the Bill in its current form could actually put patient safety at risk.

“I am not interested in pushing this into the long grass. It should be given priority but we must get it right. Such an examination of the issue should involve patient organisations, legal bodies, royal colleges and medical unions.”


What Next for the Medical Innovation Bill?

The Liberal Democrats have prevented the House of Commons from debating the Medical Innovation Bill.

→TELEGRAPH: Fury as Lib Dems block Medical Innovation Bill

→SIGN: Petition demanding Nick Clegg debate the Bill

The Bill is on the order paper for Second Reading on 6th March 2015 – but with so many Bills on the list there will never be time for MPs to have a debate.

The Government had found time for a full debate. The debate would not have been whipped – meaning MPs could vote according to their own preference. It would have been truly democratic.

However, the Liberal Democrat leadership had the right to veto debate, under the terms of the coalition agreement set up when the Tories and Lib Dems joined forces in 2010 to form a government.

And veto it he did – meaning the there will now be no debate on the Medical Innovation Bill in the House of Commons.

This veto is of concern on two levels.

The Bill sought to provide clarity and certainty for patients and doctors at the point of treatment,  by setting clear statutory criteria for responsible and irresponsible innovation.

It would have ended the present litigation lottery, according to which you only find out whether treatment was responsible by setting up opposing teams of medical witnesses in expensive and protracted litigation after the fact.

And it would have paved the way for the establishment of a ground-breaking register of innovation results, allowing positive and negative results of new treatments to be shared, pointing the way to new full clinical trials, and reducing the appalling number of wasted lives.

The blocking of the Bill is therefore a medical calamity; but there is also a constitutional issue.

The Bill was the subject of a Written Ministerial Statement approving the fundamental policy, a Government public consultation, and four full debating stages in the House of Lords.

The patient safeguard provisions were amended by the Medical Director of the NHS at the request of the Secretary of State for Health.

Other medical and legal peers tabled amendments which were accepted into the Bill.

→SIGN: Petition demanding Nick Clegg debate the Bill

The degree of cross-party scrutiny and consensus was unparalleled for a private peer’s Bill, reflecting the extreme importance of its subject matter.

The Conservative front-bench, with Labour co-operation, found a way to allow the Bill to be debated in the House of Commons; by vetoing that, and refusing to allow the issue even to be debated, the Liberal Democrats have shown utter contempt for the House of Lords, and a total disregard for the right of Members of Parliament to debate matters of crucial importance to their constituents.

The passing of the Medical Innovation Bill, with any additional safeguards or qualifications that the House of Commons had wanted to add to those proposed by the House of Lords, would have been a magnificent achievement in the final stages of this Parliament.

It would have reminded citizens that Parliamentarians on all sides are committed to doing everything possible to improve the health services, to encourage responsible innovation, to use shared anonymised health data to accelerate medical progress, and to protect patients and doctors.

That opportunity has been missed so that the Liberal Democrats could demonstrate their political power within Government: voters will not forget or forgive that lightly.

Where are we now?

Tthe Labour Party’s shadow Health Minister, Andy Burnham MP and Margaret Hodge MP (Labour) came out in favour of the Bill, further isolating the Lib Dems.

David Cameron, the Prime Minister who had supported the Bill,told the Telegraph that Mr Clegg and the LibDems would have to defend their decision

The Prime Minister’s official spokesman said: “The Prime Minister has expressed his support for this – there were changes that were made during its passage through the Lords with regard to safeguards.

“He would have wanted the Bill to go ahead clearly because he was supportive. He has argued for it to go ahead and those who have come to it differently will have to as they have explain their position.”

So it has government and opposition support in the Commons.  And supporters angered by the Lib Dems – and even some open-minded opponents who support and trust the democratic process – have spoken in number in favour of a debate on the Bill.

At best we are right back at the beginning.

It has taken more than two years to get to this stage – after a long public consultation, four debates in the House of Lords and a review undertaken by NHS chief Sir Bruce Keogh.

As you would expect we are doing our best to see if there is anything else we can do but unfortunately it does not look at all hopeful.

As things stand, it is a matter for supporters to tell us what they want and to tell their MPs too.

→SIGN: Petition demanding Nick Clegg debate the Bill

Margaret Hodge MP (Labour) for Barking on the Medical Innovation Bill.

Margaret-Hodge-MP Medical Innovation Bill
Margaret-Hodge-MP Medical Innovation Bill

Margaret Hodge MP (Labour) for Barking on the Medical Innovation Bill.

“Innovation in medicine is essential. All that can be done for a patient who faces a poor medical prognosis must be done.

“The Medical Innovation Bill addresses one of the barriers that stand in the way of innovation in the UK, the fear of litigation or disciplinary proceedings. That fear can deter doctors from innovating responsibly, particularly at a time of rising NHS litigation costs.

“The Bill will provide clarity and certainty for patients and doctors at the point of treatment, and enable doctors to innovate confidently provided they follow transparent and accountable procedures in consultation with appropriate colleagues.

“Patient safety must always come first: responsible innovation must be encouraged and quacks must be prevented from offering false hope. Labour colleagues in the House of Lords have worked with Lord Saatchi and others to ensure that the Bill strikes the right balance .

“The addition to the Bill of a requirement to share positive and negative results of innovation in a database is, in particular, a major advance in protecting patients and supporting responsible innovation.”


Margaret Hodge MP (Labour)  has been the Member of Parliament for Barking since 1994.

She was the first Minister for Children in 2003 and was Minister of State for Culture and Tourism at the Department for Culture, Media and Sport.

On 9 June 2010 she was elected Chair of the Public Accounts Committee

Fury as Lib Dems kill off Saatchi Bill

Fury as lib dems kill off bill copy
Fury as lib dems kill off bill copy

By Christopher Hope

Published 28th February 2015

→READ: Telegraph: Fury as Lib Dems kill off Saatchi Bill

→READ: How exactly did the Lib Dems kill the debate

→SIGN: Petition demanding Nick Clegg debate the Bill

A new law to allow doctors to test new drugs on seriously ill patients without the fear of being sued has been killed off the Liberal Democrats, The Telegraph can disclose.

The Medical Innovation Bill would have allowed doctors to test cutting edge new treatments on patients to help find cures for cancer and other serious illnesses.

It was being promoted by Lord Saatchi, the advertising magnate after his wife Josephine Hart died from ovarian cancer.

However Norman Lamb, a Lib Dem health minister, has told Jeremy Hunt, the Tory health secretary, that his party will not support it despite it passing through the House of Lords.

The veto – which was made because of concerns from patients’ groups and experts – has killed off the legislation in this Parliament.

The campaigners behind the Bill savagely attacked Mr Lamb and said the decision would “haunt” the LibDem leader Nick Clegg who had “handed down a death sentence to cancer patients”.

Lord Saatchi told The Telegraph he was “in a state of shock” that the LibDems could veto a policy which was so strongly backed by the Conservatives in this way.

He said: “They have killed the Medical Innovation Bill. It is dead. By killing the Bill they have killed the hopes of thousands of cancer patients.

“It is as simple as that. Nick Clegg has handed down a death sentence to cancer patients. It is an extraordinary turn of events.

“This is a grotesque insult to the House of Lords. The Liberal Democrats are saying that the House of Commons will never debate this Bill which has been sent to it and passed by the House of Lords.

“I have no difficulty putting this at Nick Clegg’s door. I am very happy to stand that on him. There is no doubt that he has authorised the letter.

“One day he will feel very guilty about this I imagine. To do what he has done, to kill all these people’s hopes, is something that will haunt him.”

The Bill started life as a Private Members’ Bill in the House of Lords before it won government support after new safeguards were introduced last year.

It was due to be debated by MPs on Friday in a race to ensure it was put onto the statute books by the end of next month, when MPs break for the election campaign. However it was pulled at the 11th hour.

Mr Lamb has now offered a review of the plans, chaired by a senior medical expert like the Labour peer Lord Winston, which would report after May’s general election.

Dominic Nutt, a spokesman for Lord Saatchi’s campaign, added that the decision was “a shameful way to do business” and “disingenuous, dissembling cowardice”.

He said: “It is the most illiberal undemocratic move by the so-called Liberal party, to deny elected MPs the right to debate and vote on a bill supported by thousands of patients and voters.”

He accused Mr Lamb of “monumental and feudal arrogance”, adding: “Norman Lamb knows that he is finding a way to kick this into the long grass and that he has personally destroyed the bill without the option for a vote.

“Norman Lamb claims he supports it, yet he has personally and singlehandedly destroyed it with a stroke of his pen.”

Mr Nutt said the Bill – technically a Private Members Bill with Government support – had “undergone a full public consultation, two years of media scrutiny, four full debates in the House of Lords” and been amended by all parties and medical and legal experts.

However Mr Lamb hit back, claiming that there were real doubts about the legislation as it has been drafted, saying that the decision to axe it was “a collective decision”.

The Bill had come under sustained attack from personal injury lawyers who said it would leave patients at the mercy of “maverick doctors”.

Writing for The Telegraph’s website, Mr Lamb said: “The Liberal Democrats have listened to the concerns of patient organisations, research charities, legal bodies, royal colleges and medical unions who have told us the Bill in its current form could actually put patient safety at risk.

“Surely we shouldn’t rush this through the House of Commons under pressure of time before the general election when organisations like the Patients’ Association, Action Against Medical Accidents, the Wellcome Trust, the British Medical Association and the Royal College of Physicians raise serious concerns?”

→READ: How exactly did the Lib Dems kill the debate

→READ: Support for the Bill

Some “highly vulnerable people, desperate for a chance of recovery or remission, could be easy prey for exploitation by the few unscrupulous practitioners who peddle false hope”, he said.

“So, faced with this level of concern, but recognising the profound importance of innovation and of saving lives, the best way to proceed is surely to appoint an eminent person examine what the barriers to innovation really are and how best to overcome them.

“I am not interested in pushing this into the long grass. It should be given priority but we must get it right. Such an examination of the issue should involve patient organisations, legal bodies, royal colleges and medical unions.”

Sarah Wollaston, the chairman of the House of Commons’ Health select committee, supported Mr Lamb. She said: “It was unnecessary, there would be a huge number of unintended consequences.

“This was the wrong answer to medical innovation. It would hamper recruitment for medical trials. It was a ‘charlatan’s charter’ and will lesson protections for patients.”

Another opponent Sir Robert Francis QC, who carried out the review into scandal at Mid-Staffordshire Hospital and president of the Patients’ Association, added: “I have every sympathy with Lord Saatchi and all those who have been through the terrible experience of finding that they are not offered treatment which they believe might offer the chance of saving their lives or improving their condition.

“However I do not agree that the cause of any reluctance on the part of the medical profession to offer treatments of this kind is anything to do with the fear of being sued for negligence. I am afraid that because it starts from the wrong place.”

Mr Francis said that the Bill would “cause confusion, lead to a greater threat of legal consequences because of the additional uncertainties it creates [and] make it more likely that those few doctors who have ulterior motives for offering or trying to sell dubious treatments could exploit a very vulnerable group of patients”.

→SIGN: Petition demanding Nick Clegg debate the Bill

Nick Clegg and Lib Dems Refuse to Debate the Bill – and Kill It

Nick Clegg and the Liberal Democrats have refused to debate the Medical Innovation Bill in the House of Commons in doing so they have killed the Bill.

The Bill has been extensively debated four times in the House of Lords.

It has been the subject of a Department of Health consultation, and the team have consulted and debated widely across the medical and legal professions for two years.

The BIll has received numerous amendments refining the process and improving patient safety.

And yet the Lib Dems refuse to even allow it to be debated in the House of Commons.



Tweet Nick Clegg and give him your views – @Nick_Clegg

Email him:

Or email him using the form on his website

Post-hoc scrutiny of medical innovation is inadequate

Professor Jo Samanta - Medical Innovation Bill / Saatchi Bill
Professor Jo Samanta – Medical Innovation Bill / Saatchi Bill

By Professor Jo Samanta - Reader in Medical Law at Leicester De Montfort Law School writes about the Medical Innovation Bill (Saatchi Bill) and the law.

Post-hoc scrutiny of medical innovation is inadequate

The publicity around Lord Saatchi’s Medical Innovation Bill has put innovative therapy high on the political and public agenda.

I broadly support the Bill, and think there needs to be a clear balance between the risks of innovation and patient safety.

It is my view that the Bill can be fine-tuned to meet this challenge. In a paper recently published in the Journal of Medical Ethics – Quackery or quality: the ethicolegal basis for a legislative framework for medical innovation – I, along with my co-author, argue that a regulatory framework is needed to allow a full consideration of the applicability of innovation, prior to the proposed treatment taking place.

In this blog I focus on the issue of pre-treatment scrutiny of proposed innovative treatment, rather than post-hoc scrutiny and of the issue of valid patient consent to innovation.

The vociferous debate over the recent Medical Innovation Bill introduced in the UK by Lord Saatchi is testament to the continuing relevance of innovation for contemporary healthcare provision.

The Bill has been criticised by some, with suggestions that the proposed legislation is unnecessary and might even promote quackery.

However, this criticism is perhaps too harsh, since innovation has often been the impetus for a range of diagnostic and therapeutic developments in medical science.

Legislation would permit doctors to deploy medical innovation optimally for the benefit of patients and within a legitimate assurance framework.


As yet there is no formally established quality assurance framework for proactive evaluation of innovative therapy in respect of its applicability, or suitability, prior to delivery.

The existing pathways tend to be post hoc review through litigation, regulatory or disciplinary processes, or local procedures such as root cause analysis, serious incident review, or clinical audit.

These ‘after the event’ mechanisms are unsatisfactory, since they are usually predicated on some form of adverse outcome.

The Bill seeks to encourage ‘responsible innovation’ on the basis that doctors will not be prima facie negligent for deciding to depart from the existing range of accepted treatment if their decisions are transparent and accountable and all relevant matters have been considered fully.

For an action in negligence, the question for the court will be whether the doctor has breached the standard of care expected in law.This is based on the Bolam test with the Bolitho proviso that the decision withstands ‘logical analysis’.

Both these tests could be problematic in the context of innovative practice. A standard for responsible innovation that is defined by legislation would carry the force of law, provide clarity for the de jure limits of innovative practice, and offer protection against improper experimentation on patients.

Innovative therapy falls between two highly regulated areas: standard medical treatment and clinical research.

The regulatory mechanism of post hoc review is largely unsatisfactory. In the presence of terminal or incurable illness, patients may be vulnerable to a greater or lesser degree and might not be best placed to assess the risks and benefits of potential innovations adequately, particularly if they believe they have nothing left to lose.

It has been argued that since the decision-making process is based typically on an individual doctor–patient axis, a clear framework is needed for appropriate regulation.

Innovative therapy includes departures from standard medical therapy, which may lack an evidence base or a demonstrable safety profile. The primary purpose of innovation must be to benefit the individual patient.

I hold that legislation of medical innovation would be beneficial. Legislation would provide a legal standard for responsible innovation, define the boundaries of acceptable medical conduct in this area, and provide the basis for legal protection of patients (many of whom could be highly vulnerable) against wrongful exposure to inappropriate therapies (at best) or unwarranted experimentation (at worst).

I propose that the Bill could be further refined through a two-stage test for embarking on responsible innovation, by creating mandatory requirements for ongoing oversight accountability, and by placing patient-centred care at the heart of the statute with an emphasis on consent and compassion. There is need for fine-tuning between empathetic care, innovation and regulation in order to get the balance right.

→READ: For a wider exploration of this issue see Quackery or quality: the ethicolegal basis for a legislative framework for medical innovation

Another argument against the Bill has been around the concern that vulnerable patients are not able to consent validly to innovative treatments.

Valid consent is a necessary precursor for therapeutic treatment of competent patients and raises particular challenges in the context of innovation.

The human instinct to cling to hope together with a dearth of alternative options might mean that duress of circumstances can interfere with the validity of apparent consent.

The potential vulnerability of those who seemingly have ‘nothing to lose’ is recognised in international guidance for research participants with incurable and life-limiting conditions.

Nevertheless, while circumstances such as these may well affect freedom of choice, it is wrong to conclude that this inevitably compromises autonomous choice.

The possibility of well- intentioned beneficent medical paternalism needs to be guarded against and further strengthens the argument for legislation.

Professor Jo Samanta is Reader in Medical Law at Leicester De Montfort Law School. Her primary research focus is on end-of-life decision making. She is the lead author of Medical Law – Palgrave Law Masters and is Chair of the Business and Law Faculty Human Research Ethics Committee. ENDS

Film: The professor who ‘cured’ his cancer with a cocktail of everyday pills and 20 years on remains disease-free

In the Telegraph today Ruth Wood writes about new documentary Surviving Terminal Cancer

From the filmmakers:

“This film charts the remarkable story of Ben Williams, professor emeritus of experimental psychology at University of California, San Diego. Diagnosed in 1995 with a lethal cancer, a primary brain tumour called glioblastoma multiforme, he was given just a few months to live.

But a natural born maverick, and rigorous scientist, Ben decided he would not go down without a fight. Nineteen years later his story is an inspiration to patients the world over, whilst his case is dismissed by the medical community as just one of a handful of statistical outliers.”

Watch the trailer

From the Telegraph:

ONE day, some two decades ago, Ben Williams set out from his home in San Diego, California, to cross the border into Mexico in search of acne tablets. The 50-year-old psychology professor didn’t actually suffer from acne. What he had was the deadliest type of brain tumour, a glioblastoma multiforme that was the size of a large orange. A leading neuro-oncologist from Texas had suggested that a skin treatment, called Accutane, might help him.

Prof Ben Williams was diagnosed with the tumour in March 1995. “The entire right side of my brain was infested with a tumour,” he recalls. “Apparently brain tumours as large and ugly as mine are a notable event. Soon half the neurology department had shown up to look at the scans.” He underwent surgery the following afternoon. However, relations with his neurologist soon became strained due to his dogged insistence on researching his own treatments.

His doctor wanted him to stick to the standard regimen of surgery, radiotherapy and chemotherapy. But the rebellious Harvard alumnus insisted on adding to this a veritable cocktail of drugs – in addition to the acne pills, there were blood pressure and insomnia tablets. All were cheap and had little or no toxicity, and for all of them Williams had gathered some credible evidence from scientific trials that they might reduce his tumour, boost his immune system and make chemotherapy more effective. But none had been approved in the United States for use in the management of brain tumours, so his own specialist had dismissed them.

“He said I would drive myself crazy researching all these things and that I might hurt myself,” recalls Prof Williams, whose story is told in a new film, Surviving Terminal Cancer, released online today. “I almost laughed. Hurt myself? I had the most aggressive kind of brain tumour. I was expected to die in a year. What did I have to lose?”

Even today the average life expectancy for patients with glioblastoma multiforme is just 15 months, with survival rates highest among young people. Fewer than 10 per cent of people aged 50 and above survive for five years. So it is against all odds that Professor Williams has just celebrated his 70th birthday and 20 years of clean MRI scans.

“I’d been told that my chemotherapy wouldn’t get rid of the tumour completely or indefinitely, so I focused on finding agents that might make chemo work better for me,” he says. Sure enough, after his fourth round of chemotherapy in 1996, Prof Williams’s tumour had vanished. It has never returned and thousands of people, including oncologists, have sought his advice since on ”beating” a cancer known in medical circles as “The Terminator”.

In mainstream oncology Professor Williams is considered a freak case and his strategy of fighting cancer “using every potentially efficacious agent I could lay my hands on” attracts suspicion. Yet a growing number of specialists and researchers say there is evidence that some of the common pills taken daily by millions for other ailments, could be ‘‘repurposed’’ to help in the battle against cancer.

“We just need to look in our medicine cabinets,” says Pan Pantziarka, scientist and UK spokesman for the Anticancer Fund, a Belgian non-profit organisation run by researchers and doctors. “There is strong evidence that some of the medicines we use every day have anti-cancer properties.”

At present, the pharmaceutical industry is using advances in our understanding of genetics to create so-called ‘‘magic bullets’’, a new generation of ever smarter, ever more targeted therapies. These act like snipers, interfering with specific cell proteins or signalling pathways that have a role in cancer. Major successes with this approach include the chronic myeloid leukaemia drug imatinib (Glivec) which blocks a protein that makes cancer cells grow and divide.

But, according to Professor Angus Dalgleish, Foundation Chair in Oncology at St George’s Hospital, University of London, many targeted therapies are eventually doomed to failure.

“Cancer will do everything it can to survive and avoid being hit,” he says. “It’s like a traveller who wants to cross London on the Tube. Yes, you could block him by taking out a major station like Oxford Circus, but he’ll just switch to a different line. It’s the same with cancer. After getting hammered by one agent, the tumour quickly reinvents itself through evolution. I always delay giving these targeted therapies as long as possible because I know they’re not going to be working a few months down the line.”

It costs more than $1billion (£650 million) to bring a new cancer drug to market and takes more than a decade. As drug companies face an increasingly uphill battle to invent new chemical entities that can be patented, they pass on the cost of a 90 per cent-plus failure rate, expensive trials and marketing to the NHS, insurance companies, healthcare providers and patients. Such is the spiralling cost that the Government now runs a separate £280 million-a-year Cancer Drugs Fund to shield NHS budgets – and even that is expected to overspend by £100 million this year. In January, the Government announced that 16 life-extending drugs would no longer be paid for by the Fund because of cost-cutting.

The good news is that early-stage laboratory experiments and clinical studies, as well as large scale epidemiological research point to the potential cancer-fighting properties of dozens of existing medicines that millions of people take safely every day for other ailments. Aspirin is the most high-profile example. Research funded in part by Cancer Research UK shows that it can significantly cut the risk of bowel, throat and stomach cancer if taken daily by people aged 50-65 (although the CRC warns on its website that aspirin can have side effects and should not be taken regularly without medical advice).

The Repurposing Drugs in Oncology (ReDo) Project, an international collaboration between the Anticancer Fund and US-based non-profit organisation Global Cures has identified 70 potential agents for which there is evidence of cancer-fighting properties. These include the diabetes tablet metformin, cholesterol-lowering statins, the antacid cimetidine, the de-worming tablet mebendazole, the anti-fungal itraconazole, and all the drugs Professor Williams took as he battled his brain tumour.

“Most modern cancer drugs are known as targeted therapies because they are aimed at very specific targets inside cancer cells,” says Dr Pantziarka. “But these older medicines are known as ‘dirty drugs’ because they have multiple targets, interfering with more than one protein or signalling pathway at a time. Used in combination, they could be very effective.

“If these medicines were coming out today, some would be blockbuster cancer drugs. But most are no longer covered by patents so the pharmaceutical industry has no financial incentive to investigate them.”

Even though these medicines are not officially labelled as cancer drugs, doctors are legally entitled to prescribe them “off-label” if there are solid grounds to believe they will be beneficial. Indeed, Lord Saatchi’s Medical Innovation Bill, which is supported by the Telegraph, aims to give oncologists (and specialists in other fields) more confidence to be experimental in treating terminally ill patients for whom all existing therapies have failed and who are prepared to take risks. But in practice, most oncologists are unwilling to prescribe drugs that have not passed final-stage (Phase III) clinical trials for a particular type of cancer, and even more wary of combinations that may interfere with conventional treatment or have unforeseen side effects.

Professor Dalgleish is one of the few UK doctors willing to think differently. “Say we have a patient who is fit and healthy in many ways but is going to be dead within months. If that patient asks me, ‘Is there anything else I can do?’ I will say, ‘Yes. The data suggests you could consider metformin which appears to selectively reduce glucose uptake by tumour cells as opposed to normal cells. I suggest aspirin to tackle your inflammation and let’s correct your vitamin D levels to boost your immune system.’

“I call it creative compassion because it’s not in the rule book and it’s what I would want for myself if I were in the same position. I wouldn’t want to just be told to go and see the palliative care person.”

Professor Justin Stebbing, of Imperial College London, the oncologist who treated actress Lynda Bellingham before her death from bowel cancer last year, agrees with the approach, though he tends not to prescribe off-label drugs himself.

“That’s not because I’m ethically opposed to the idea, but it’s not something I do every day so I’m not knowledgeable about dosages,” he says. “However, I don’t have a problem if patients get the drugs elsewhere and am open to referring them to trials that test these alternative approaches.

“As a profession, we can be cruel to cancer patients, giving them treatments that are horribly toxic with minimal benefits. I find it very frustrating when my colleagues are dismissive of patients who want to try other things that are non-toxic and may extend their lives.”

Professors Dalgleish and Stebbing are the co-authors of a study into “cocktail cancer therapy” currently taking place at the Care Oncology Clinic in London. Over the next five years, the private clinic run by biotech firm SEEK is aiming to treat more than 10,000 cancer patients with a combination of four ‘dirty drugs’ — statins, metformin, the de-worming drug mebendazole and doxycycline, a common antibiotic.

Gregory Stoloff, founder of SEEK, says it’s a non-profit trial funded by patients themselves, who pay £400 for the initial consultation, then £200 every three months to cover the cost of the drugs, consultations and the trial.

“Oncologists refer patients to us who have run out of treatment options and we put all of them on the treatment right away,” he says. Because nobody is given a placebo, this is not a controlled clinical trial. But SEEK hopes that treating thousands of people will create enough data to enable an effective comparison with cancer survival rates in the rest of the population. “Controlled clinical trials are all very well but when you have people who are expected to die within months they want treatment now. And these are very safe medicines that people have been taking for decades.”

Although Phase III clinical trials remain the gold standard for science, they don’t necessarily serve cancer patients well, says US campaignerDominic Hill, in whose film Prof Williams appears, along with oncologists researchers and other cancer survivors.

“Today’s lifesaving treatment for HIV [called antiretrovirals] is given to patients despite it never having passed a randomised Phase III clinical trial,” Mr Hill, whose brother-in-law Andreas died of a brain tumour in 2010, points out.

“How many cancer patients must die before the regulators recognise that this approach needs to be adapted to oncology?”

Dominic Hill’s film Surviving Terminal Cancer is free to watch

The Drugs in Question: the evidence for and against

Metformin: Several studies suggest that tumours grow more slowly in cancer patients who take this anti-diabetic drug. Early-stage clinical trials are investigating its potential to prevent various cancers including prostate, breast, colorectal and endometrial.

Statins: Preclinical studies suggest these cholesterol-lowering heart drugs may prevent various cancers and stop them spreading. One recent meta-analysis associated a daily statin with a significant risk reduction of liver cancer.

Mebendazole: There is evidence this drug – usually prescribed to treat parasitical worm infections — may inhibit cancer cell growth and secondary tumours, though no clinical trials have been completed.

Cimetidine: This over-the-counter antacid has direct anti-proliferative effects on cancer cells, inhibits cell adhesion, reduces tumour angiogenesis (growth of blood vessels essential to a developing tumour) and also boosts anti-cancer immunity in various cancers.

Itraconazole: The common anti-fungal treatment is also thought to be anti-angiogenic and has shown promise as an agent for prostate cancer, non-small cell lung cancer and basal cell carcinoma, the most common kind of skin cancer.

Isotretinoin: This acne drug, marketed as Accutane, is occasionally used to treat certain skin cancers and neurological cancers as well as to prevent the recurrence of some brain tumours, although some studies suggest it is ineffective.

What does Cancer Research UK think?

Professor Peter Johnson, chief clinician at Cancer Research UK, said: ‘It’s completely understandable that when faced with a terminal cancer, patients and their doctors want to explore every possible treatment option, but it’s important to balance the wish to do something against the problems such as side effects and false hopes.

“Cancer doctors in the UK are very innovative and often try new treatments if they and the patient feel this might be of benefit. The thing which sometimes prevents us from using different treatments is not our reluctance or a fear of being sued, but NHS funding. The NHS requires good evidence a treatment will work, which is why we carry out research trials, and more UK patients go on clinical trials than anywhere else in the world.

“Clinical trials are essential to find out whether new treatments are safe, if they are better than the standard care, and which patient groups will benefit. The only way to improve cancer medicine and show that a new treatment should be given to patients is by analysing trial results, which are scrutinised to make sure that they are ethically sound and scientifically valid. There are many different ways to do trials, but they all have the same goal: to find the best and safest forms of treatment. The people who take part in trials know that even if they themselves don’t benefit, they will help other people in the future.

“It doesn’t make sense for patients to withhold information from their doctor about other medicines they are taking. Many drugs, even those sold as natural remedies, can interfere with each other and the results can be very dangerous, or even fatal.”

Update on the Saatchi Bill

The Medical Innovation Bill, which would protect patients and doctors who want to try experimental treatments, is just days away from either becoming law — or becoming a footnote in the history of scientificadvance.The Private Member’s bill sponsored by Lord Saatchi has been debated four times in the House of Lords, tested and amended by Labour, Tory and Lib Dem peers and scrutinised and approved by doctors, lawyers and judges in the upper chamber. It is supported by both the Government and Opposition front benches. It is also backed by patients and their families – more than 40,000 have signed up as Medical Innovation Bill supporters.The Bill now includes a register that will see the results of all innovations recorded so they can be shared and used by other doctors and researchers. Having been amended and passed by the Lords, the Bill must now be approved by MPs in the Commons. But time is running out – Parliament has only weeks to complete its business before it is dissolved ahead of the May election. It is now up to the Government to find time for the Bill to be debated. If this does not happen the Bill will fall.

The full film has been released today online – Watch it here