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NHS: Clinical Trials


11.27 am

Asked by Lord Patel

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The Parliamentary Under-Secretary of State, Department of Health (Lord Darzi of Denham): My Lords, the Government are working to make the UK the best place in the world for health research. The NHS has a vital part to play in this, and the NHS Constitution recognises that. Our health research policy, Best Research for Best Health, will ensure that the NHS is fully equipped to make its contribution. It will ensure that we deliver our national ambition to double the number of patients taking part in clinical research trials in the next five years.

Lord Patel: My Lords, I thank the Minister for his encouraging Answer. I declare an interest: I am a member of the Medical Research Council and associated with the best university doing research in life sciences and clinical medicine. Of course I agree that much has been done to improve the climate for clinical trials, but concerns were reported recently in the press and journals about the UK not realising the full potential of the NHS in clinical trials. We have strength in life sciences and the ability to translate research into clinical medicine. We have great strength in clinical databases, and with the advance of genomic medicine our biobanks will pay a major role. However, UK participation in global clinical trials has fallen from 6 per cent to 2 per cent. Sometimes we fail to recruit any patients for some international clinical trials. Nearly 35 per cent of sites fail to recruit any patients after trial set-up. Clinical trials in the NHS are suffering. Clinical trials are an important part of quality healthcare; does the Minister think that they should be part of quality accounts?

Lord Darzi of Denham: My Lords, I agree. Innovation in science, mostly within the NHS, has significantly improved the quality of care that our patients receive in the NHS. We have seen numerous examples of this in the past 60 years. However, we can always do more, and recruitment to clinical trials is important. As it stands, the operating framework within the NHS has the following three principles. All providers of NHS care will need to increase their participation in research. The national ambition is to double the number of patients taking part in clinical trials and other well designed research studies within five years. Strategic health authorities are expected to show that NHS trusts work with the National Institute of Health Research and its clinical research network to increase recruitment to clinical trials. On the issue of whether research indicators should be part of quality accounts, I sympathise that research is a reflection of quality and I have asked officials to look into that. If an indicator is identified, I have no doubt that we will consult the service on whether it should be part of the quality accounts.

Baroness Gardner of Parkes: My Lords—

Lord Walton of Detchant: My Lords—

Baroness Gardner of Parkes: I think we just heard from the Cross Benches.

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The Minister of State, Department of Energy and Climate Change & Department for Environment, Food and Rural Affairs (Lord Hunt of Kings Heath): My Lords, shall we hear the noble Lord first and then the noble Baroness?

Lord Walton of Detchant: My Lords, would the Minister accept that for many years the National Health Service has been regarded in the UK as an ideal environment in which to perform clinical trials and that the support that the Government have given to medical research is much appreciated? Is he able to say, however, what effect the EU clinical trials directive is likely to have in the long term on the performance of such trials? Is he aware that the very complex and at times tortuous requirements now imposed upon clinical trials for ethical reasons, particularly for multicentre trials, have led certain pharmaceutical companies to propose moving their trials overseas because of the difficulty of obtaining ethical approval?

Lord Darzi of Denham: My Lords, I am aware of the EU clinical trials directive and we have consulted our stakeholders here. The stakeholder to which the noble Lord refers, the pharmaceutical industry, has consistently confirmed that it is content with the broad thrust of the EU directive, since it reinforces systems and practices to which it already conforms. We are aware, however, that there have been some challenges for non-commercial trials and we are now working with our partners in research charities, the Medical Research Council and the National Institute for Health Research in universities, to understand these problems and resolve them.

Baroness Gardner of Parkes: My Lords, my question follows on very well from the last question. Is the Minister aware of the extreme difficulty encountered by consultants trying to do small-scale clinical research? I quote the example of a consultant dermatologist who wishes to try, on just four patients, a drug that has been widely accepted and used for 40 years without any problem. He wishes to try this on four lupus cases as he believes that it may have a use, but, under that EU directive, he finds himself stuck in the position that he has to fill in as many forms and deal with as much bureaucracy as if he were a major pharmaceutical company. I have raised this matter informally with the Minister’s department. This consultant’s trust cannot afford the money involved in all that bureaucracy, so cannot something be done to make it easier?

Lord Darzi of Denham: My Lords, I have already said that we shall be looking at the impact of the EU directive on non-commercial trials, but perhaps I may also say, in the context of bureaucracy, that a lot of reform has happened within the system. To name just a couple, we have created a UK regulatory and governance advice service which provides researchers, such as the consultant referred to, with free access to expert advice and information about regulation. We have also created the National Research Ethics Service, which facilitates and promotes ethical research by working to maintain a UK-wide system of ethical review via NHS research and ethics committees.

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Baroness Tonge: My Lords, the Minister must realise that a new academic registrar may spend the whole of his 12-month fellowship seeking approval for a particular research project and then have to leave. We have the longest average approval time for clinical trials in the whole of Europe. As a very eminent researcher, probably one of the greatest researchers in medicine in this country, and now a Minister in this House, surely he is in a position to speed things up and make conditions better for researchers here.

Lord Darzi of Denham: My Lords, I am grateful for the noble Baroness’s kind words. She asked what we need to do to reduce bureaucracy further. As I have said, we have reformed the system, but I agree that there is more to do. I am very grateful that she acknowledges the investment that the Government have made in creating 250 academic clinical fellowships across the country.

Lord McColl of Dulwich: My Lords, is it worth emphasising to the public that patients involved in controlled clinical trials receive even better treatment than those not in the trials?

Lord Darzi of Denham: My Lords, I am grateful for the noble Lord’s intervention. I agree that the recruitment of patients for clinical trials has a tremendous impact on the quality of care that the NHS can provide in the future, compared with when patients do not take part in a clinical trial. I agree with the sentiment of the noble Lord’s question and I have no doubt that that message and culture need to be disseminated across the NHS.

Lord Lyell of Markyate: My Lords, I declare an interest as a beneficiary of a cancer drug, Avastin, which is a standard treatment for colon cancers in the national health services of France, Germany and elsewhere in Europe. Why are Ministers not even permitting NICE to carry out trials on it in this country for this purpose, and when do they hope to give such permission?

Lord Darzi of Denham: My Lords, we have debated this issue in this House on numerous occasions. One output of the next stage review was a reform of the way that we appraise, through NICE, evidence relating to certain drugs affecting certain conditions, colorectal cancer being one. I reassure the noble and learned Lord that NICE will be looking at these drugs as we collect more evidence, and some of that evidence will come from clinical trials involving the recruitment of patients on Avastin in this country. I have no doubt that, once the evidence is available, Avastin could be one of the many other drugs that our patients receive in the NHS.

Baroness Howarth of Breckland: My Lords—

Lord Hunt of Kings Heath: I am sorry, my Lords, we have reached 30 minutes.

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Arrangement of Business


11.37 am

Lord Bassam of Brighton: My Lords, with the leave of the House, my noble friend Lord Tunnicliffe will repeat a Statement made in the other place entitled “Records of Detention: Review of Conclusions”. We will take the repeated Statement at a convenient point after 2 pm.

Saving Gateway Accounts Bill

First Reading

The Bill was brought from the Commons, read a first time and ordered to be printed.

Health and Social Care Act 2008 (Registration of Regulated Activities) Regulations 2009

European Parliamentary Elections (Franchise of Relevant Citizens of the Union) (Amendment) Regulations 2009

Representation of the People (Amendment) Regulations 2009

Parliamentary Constituencies (England) (Amendment) Order 2009

Motion to Refer to Grand Committee

Moved By Baroness Royall of Blaisdon

Motion agreed.

Business of the House

Timing of Debate

11.38 am

Moved By Baroness Royall of Blaisdon

Motion agreed.

Foreign Policy


11.38 am

Moved By Lord Marlesford

Lord Marlesford: My Lords, it is a great honour to be asked to open this debate. When I saw the list of distinguished speakers, I felt greatly over-promoted.

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However, my deficiencies will be more than made up for when my noble friend Lord Howell of Guildford replies to the debate from our side. All I can hope to contribute are some thoughts on the backdrop to a generally unhappy situation facing the world.

A tidal view of history explains why it is so hard to decide in which direction events are moving. Tides rise and fall. The turn of the tide is especially hard to spot because, unlike lunar tides, there are no timetables, and surface storms can conceal what is happening in the longer term. Most political thinkers and leaders ride the tide, or are swept away by it. A few play a part in turning it. Martin Luther, Karl Marx, Deng Xiaoping and Margaret Thatcher were tide turners; so perhaps were Ronald Reagan and Pope John Paul II. Now, Barack Obama has been elected on a wave of hope to lead his country.

Each tide-turner has identified a need for change and met the challenges that change creates. What are the challenges from which new opportunities may emerge? The first and greatest challenge is for national leaders—and not only politicians—to understand how people really feel and, thus, why they react as they do. Nowhere is this more important than under the shadow of world economic collapse. Ordinary people do not understand what is happening and nor, indeed, do the pundits. Having been swept along by a tide of credit, much of it toxic to borrowers as well as to lenders, they are waking up to a day of reckoning. That tide could still turn into a tsunami. Part of the prosperity of the past decade has been an illusion. Consumers have now changed direction and it is no good economic and political leaders urging and expecting them to spend to support demand. A cat that lands on a hot stove will avoid stoves, hot or cold, for a long time.

An early casualty of a depression is international altruism. It is replaced by domestically perceived self-interest. Protectionism leads to retaliation and so extends and prolongs a world recession. The bid by Congress to include the “Buy America” provisions in the American stimulation package was the first challenge that President Obama faced. He was helped to mitigate it by the immediate and very effective protests from the EU Commission. Perhaps predictably, China has indicated a determination to tackle the slowdown without resorting to protectionism. China was one of the first to spot and face the realities of our new economic situation.

Countering protectionism is, I believe, the top priority for the EU today. It is far more urgent than haggling about Lisbon. I foresee serious problems, particularly in France where President Sarkozy is already advocating blatant economic nationalism. Admittedly, the shadow of 1968 hangs over Paris. However, if members of the EU introduce internal protectionist measures, whether for goods or workers, it will contradict not only the terms of the single market, but the whole concept of the treaty of Rome and its successors.

Perhaps the greatest and most dangerous political challenge is the West’s present conflict with Islamicism. It is perceived through much of the Muslim world, especially in the fragmented Middle East, as a re-enactment of the Christian Crusades. The thousand-year memories of the massacre of Muslims by Christians in Syria and Palestine had faded until they were

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reawakened by European colonialist ventures in the latter part of the 19th century. With the end of the Ottoman Empire those memories slumbered again, but resentment of western exploitation—sometimes amounting to expropriation—of Muslim-owned oil led to the formation of OPEC in 1960. The subsequent oil shocks were the equivalent of huge tax hikes on the populations of oil-importing countries.

Since then, there has been a tidal change, with the Islamists, whose ideology is sometimes so extreme as to be a perversion of Islamic teaching, setting the agenda. Al-Qaeda has been in the vanguard, invoking jihad partly to settle scores inside the Muslim world, but also evoking the history—and probably the myths—of Saladin against the West. President Bush’s use of the word “crusade” after 9/11, reinforced by his “axis of evil” speech of 2002, has empowered the fundamentalists and played into the hands of the jihadists.

I believe that the West must show a new respect for the ancient and pre-Islamic civilisations of the Middle East. I believe that Turkey and Syria could then offer keys to progress on the Israel/Palestine situation, which continues to drip its poison into the area. This challenge is largely in the hands of the United States. Without American weapons and the annual military grant of some $2.4 billion, Israel would be defendable only with its own nuclear weapons. If a two-state solution is achievable, it will have to be recognised by Israel as its only viable option. Even on a small scale, Israel has been demonstrating that military action can now only reveal weakness. The failure of the 2006 Hezbollah war may have been repeated in Gaza this year because Israel’s declared intention of ending rocket attacks does not seem to have been achieved. History shows that eventually, however unpalatable, radical movements with popular support have to be engaged. Equally, Hamas and Hezbollah will have to accept that their own declared aims are not achievable. But with perhaps four years to get there, an American military commitment to a two-state solution could produce peace.

Iran is another country which has been sadly mishandled. The Shah, a weak and rather vain man whose overthrow 30 years ago was last month celebrated in Tehran, alienated his religious subjects by confusing modernisation with the introduction of some of the least attractive aspects of western culture. We should not be surprised that accusations of western global arrogance land on fertile ground in Iran. The Anglo-American monarchist plot in 1953 which overthrew the elected Prime Minister Mosaddeq because he had dared to nationalise British-owned oil is still remembered, and America’s decision to back Saddam Hussein when he attacked Iran in 1980 cost more than 1 million Iranian lives. Iran is another country whose long and distinguished history entitles it to our respect. We, after all, are relative newcomers to civilisation. Yet we patronisingly appear to deny the Iranians the right to nuclear reactors for power generation lest they be used for building nuclear weapons.

Nuclear weapons are probably as controversial as they have ever been. There are those who say that the great challenge is to rid the world of such abominations, and that every country which joins the nuclear club increases the chances of world disaster, so almost any

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steps are justified to prevent entry to it. I myself am not of that persuasion. First, science, however frightening, is irreversible. Secondly, had the bomb not been deployed against Japan, the world would never have recognised the horrors of its effects until uninhibited competitors, probably the United States and Russia, had resorted to a nuclear exchange. After that, there would have been little further debate because there would have been no debaters. Nuclear weapons have been clearly demonstrated as unusable. They kept the peace during nearly half a century of cold war, and perhaps what is most important is that they made conventional warfare between nuclear states too risky. Indeed in this they may in recent years have prevented serious conflict between India and Pakistan over Kashmir.

That there should be as few nuclear states as possible is desirable. The Nuclear Non-Proliferation Treaty ensured that the number of states with nuclear weapons rose only from five to nine over 40 years. Next year there will be an opportunity to reinvigorate it, and it will be worth paying a high price to do so. For example, the idea of the central provision of nuclear fuel for those countries that wish to generate nuclear power should be fully endorsed. A price not worth paying is a pre-emptive military attack against a state thought to be acquiring nuclear weapons. I refer of course to the possibility of an attack by Israel on Iran. Nonetheless, progress towards nuclear disarmament with a considerable reduction in the thousands of warheads still held by the United States and Russia must be a priority.

My instinct, but not yet my conviction, is that we should renew our own Trident nuclear deterrent. However, the two carriers are another large cost and the fleet of smaller ships is dangerously reduced. Nor are supplies for the Army or the Royal Air Force what they would like to have and what I believe they need. Our Armed Forces are already overstretched and it is an act of political immorality to commit to an operation without the best available—I deliberately say available rather than affordable—equipment. Equally, to embark on military action without adequate resources is to risk not only lives but also the reputation of our Armed Forces. That, sadly, seems to have been one result of our recent operations in the Basra area where the Americans had to sort out the mess.

This brings me to changes in Russia. Russia, under the relatively benevolent if shambolic rule of Yeltsin, was revealed as having been a much overestimated enemy of the past. Sadly, under Vladimir Putin, Russia is not contributing to world stability. The reality is that Russia is unlikely to be a military superpower again. That combined with the humiliation felt by the old Soviet nomenklatura, of which Putin was a junior member, with the dismemberment of the Soviet Union conditions Russian actions today. The Russian economy has cashed in on the commodity boom but it has failed to develop in any other meaningful way. Russia manufactures little that anyone wants to buy, with the exception of a few sub-prime weapon systems. Its population is declining and its expectation of life dramatically so. Some in Russia look back with nostalgia to the Soviet days.

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