Care Bill [HL]

Lord Warner Excerpts

Monday 10th June 2013 Lords Chamber

Moved by

[Lord Warner]

58: Clause 97, page 80, line 35, at end insert “and the publication of its findings fairly and frankly”

[Lord Warner]

My Lords, I suspect that the amendment has a similar purpose to Amendment 63, in the names of the noble Lords, Lord Turnberg and Lord Patel. The purpose is to ensure that in exercising its functions the HRA not only promotes the interests of research participants and those of the wider public in facilitating research but, in doing so, has to ensure that the publication of research findings takes place fairly and frankly. I tabled the amendment because there was concern in the Joint Select Committee, of which I was a member, about whether those responsible for conducting research were tempted on occasion to shield from public view the downside findings of a piece of research, for commercial or even professional, reputational reasons.

The Joint Committee’s discussions of that issue are set out in paragraphs 328 to 336 of its report to the Government. There was a lot of support in principle for greater transparency around research findings, and particularly clinical trials data, but there was some ambivalence in the discussions of witnesses in front of us, including the Minister, about prescribing this requirement in primary legislation. Tucked away in the discussion was a concern that this kind of approach would cause pharmaceutical companies to take clinical trials away from the UK. That was the implication, I think, of some of the remarks passed to the Joint Committee, which rightly in my view took a more robust view. In paragraph 335 of its report, it recommended that the Bill should be amended,

“so that promoting transparency in research and ensuring full publication of the results of research, consistently with preservation of patient confidentiality, becomes a statutory objective of the HRA”.

That is what my amendment aims to do.

My views on this issue have been shaped over time, but particularly by my experience as the Department of Health Minister responsible for the pharmaceutical industry and its regulation as well as for NHS R&D. In those roles, I did my bit to promote that industry and secure UK jobs in it, and I know the arguments about securing clinical trials. However, they have to be balanced with other considerations, when deliberate concealment of adverse research data has taken place. This is in nobody’s interests, including those of the company where it has taken place, because eventually it usually gets found out.

To illustrate my concerns, I want to detain the House a little longer with a brief account of what came up in my time as a Minister, when there was concealment. “Panorama” revealed, in 2003, what was happening with an anti-depressant called Seroxat, which was being given to about half a million people a year. Some of the people taking higher doses of the drug experienced suicidal feelings, and there were a number of cases of younger patients committing suicide. There was widespread concern among patient groups, and the MHRA had to launch a review, which included a small subset of younger patients under 18, for whom Seroxat was not licensed but for whom it was being prescribed by doctors. At that time, about 8,000 young people a year were being prescribed this drug, and the Committee on Safety of Medicines advised me that children taking this drug were more likely to self-harm or have suicidal thoughts. That finding was not then available to the regulators, but the public fuss caused by the media caused the company—and I want to mention it; it was GSK—to end up passing the information in its files to the regulators in the UK, Europe and the US. I took the view, in 2004, that there was a respectable case for prosecuting GSK, because it had failed to inform the MHRA in a timely fashion of the information on adverse reactions in juveniles.

The whole affair limped on after my time as a Minister and became the largest investigation of its kind. Over 1 million pages of evidence were scrutinised, with GSK challenging matters all the way. Matters were only concluded in March 2008 when the decision was taken not to prosecute GSK, which received a slap on the wrist. The then MHRA chief executive said in a press release:

“I remain concerned that GSK could and should have reported this information earlier than they did”.

This case—and there are others which I know of—illustrates why we should put in the Bill a clear requirement that research information is put into the public arena in a timely way when there is a downside as well as when there is an upside so that people can have a fuller picture of what is actually going on. If noble Lords want a fuller account of the Seroxat saga, they can find it in my book, A Suitable Case for Treatment, which is available in the Library. I beg to move.

[Lord Turnberg]

My Lords, the point of Amendment 63, which is in my name, is the need for the HRA to emphasise transparency in the reporting of clinical trials because patients and the public must have confidence that research in which they have been involved will be used in the best way to spread the message for the good of other sufferers. They have to know that results, whether negative or positive, are published. As my noble friend Lord Warner has said, it is particularly important if they are negative, for at least two reasons. First, it is to stop the unnecessary, wasteful repetition of the research by others who are unaware that it has already been done. Equally important is to prevent a bias in reports towards research that shows only that a new drug works when other, unpublished, research shows that it does not. This is particularly important when we consider what is called meta-analysis, whereby an analysis is made of all relevant published reports, brought together to provide a large database on whether a drug works or does not. If only the positive results are reported, we have a biased result at the end, which could result in all sorts of problems.

Open access to research data provides researchers with a much better picture of their field than if research results are held too closely to the chest, perhaps by researchers jealous of their findings or by drug companies fearful of rivals gaining an advantage. It is heartening to know that GSK seems to have learnt the lesson: it is the first pharmaceutical company to lead the way in transparency. Members of the Association of Medical Research Charities make it a condition of their grants that results are published. We are pushing on an open door and we just need the HRA to have some capacity to ensure transparency in NHS research.

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[Lord Winston]

My Lords, I entered the Chamber expecting to speak not to this amendment but, as the Minister may recognise, on the issue of human fertilisation. However, I am feeling drawn into the argument. I find it difficult to agree with my noble friends on this side of the House. The wording of the amendment would not really fulfil the laudable purpose set out by my noble friends. There are many examples where this information would be very important. The case of Seroxat is a fine example of where there was a real need to have better regulation of the negative results of a drug trial.

There are many examples where the negative effects of a drug trial may not be of relevance in the same sort of way. In the area of reproductive medicine, for example, clomiphene citrate was first given as a contraceptive. The surprise was that people got pregnant on it, so the drug was shelved as a contraceptive. A great deal later, however, a drug company suddenly recognised that it had something that might stimulate pregnancy in women who had been infertile. The problem is that a drug company sponsors, pays for and organises research, so to some extent it has a commercial value in that research. We have to strike a very careful balance between when there is an important commercial angle which requires proper legislation and, equally, when there is a chance for drug companies to do a good job—as they did eventually with clomiphene citrate when it was launched as one of the most successful drugs in my area of medicine.

With all due respect to my noble friend Lord Warner, that makes the wording of this amendment difficult. I do not think that frank and fair reporting of a drug trial would be sufficient to meet the needs of what he is arguing in this case.

[Lord Warner]

Perhaps I may respond to my noble friend. I was arguing the case on behalf of the Joint Committee as much as anything else. The committee heard a lot of evidence on this, and across the parties, and across the Commons and the Lords, the conclusions were drawn up in its report to the Government.

I say to my noble friend that most of these clinical trials look at a product which is being tried for a particular purpose. If that product happens to fulfil some other purpose, a different set of issues arises. Seroxat was actually trialled as an anti-depressant, but it failed that test in so far as it was applied in a dangerous way to juveniles. The information about it failing that test was concealed from the public and the regulator. My wording might not be perfect but I am not arguing for my wording. I am trying to get the Government to engage with the issue so that they can find a wording that meets my concerns—and, I suspect, those of my noble friend Lord Turnberg—in the way that the Joint Committee proposed, to engage the HRA in ensuring proper transparency when there are downsides to research. That is in no way stopping a pharmaceutical company from using a drug or trialling a drug for a different set of purposes from that for which it was originally constructed.

[Earl Howe]

My Lords, I say straight away that I sympathise with the intention behind the noble Lords’ amendments. These two amendments seek to make an explicit statement about the Health Research Authority’s role in encouraging transparency in health and social care research findings and clinical trial results.

We are all keenly aware of how topical the issue of transparency in health research is. The House of Commons Science and Technology Select Committee is currently undertaking an inquiry into clinical trials. Last week I gave evidence to that committee along with my right honourable friend the Minister of State for Universities and Science. I look forward with interest to the committee’s report. As the noble Lord, Lord Turnberg, and the noble Baroness, Lady Wheeler, rightly pointed out, maintaining trust in research is crucial to its success, and the way in which we respond to the mounting calls for greater transparency has consequences for how the integrity of research conducted in this country is perceived not just on a national level but on the international stage.

However, in reaching answers to these pressing questions, we must be careful not to create perverse incentives that simply result in people choosing not to carry out research in the UK and invest elsewhere. Promoting transparency in research is a core part of facilitating the conduct of safe, ethical research. People enrol in trials because they want to contribute to medical knowledge and advances. In considering the ethics of research proposals, ethics committees have to be assured that any anticipated risks, burdens or intrusions will be minimised for the people taking part in research and will be justified by the expected benefits for participants, or for science and society. Knowing what research has already been undertaken or is under way and the results of that research is therefore essential in order to minimise risks and burdens by not repeating research that has already been conducted.

Here, I come to the answer to the question asked by the noble Lord, Lord Hunt, in debate on the previous group of amendments. Promoting transparency in research is inextricably part of facilitating the conduct of safe and ethical research, which is the Health Research Authority’s main objective in Clause 97(2)(b). As Dr Wisely, the Health Research Authority chief executive, said in evidence to the Joint Committee which scrutinised the draft Bill, promoting transparency is absolutely fundamental to protecting patients and the public in health research. As a special health authority, the Health Research Authority is already doing a number of things with regard to transparency in research. First, research ethics committees already consider an applicant’s proposals for the registration and publication of research, for dissemination of its findings, including to those who took part, and for making available any data or tissue collected as part of the research.

Secondly, since April 2013, the Health Research Authority has been undertaking checks of research ethics committee applicants’ end-of-study reports to see whether they registered and published research as they declared they would to the ethics committee. Thirdly, as noble Lords may be aware, the Health Research Authority recently published a position statement setting out its plans for promoting transparency in research. This statement has received widespread support from stakeholders, including the AllTrials campaign, the James Lind initiative, the Association of the British Pharmaceutical Industry and INVOLVE.

I turn specifically to Amendment 63, which would specify that one way in which the Health Research Authority, the bodies listed in Clause 98(1)—for example, the Human Tissue Authority—and the devolved Administrations would be able to fulfil their respective duties to co-operate would be through encouraging transparency in the reporting of clinical trials results. The intention behind these duties of co-operation is to encourage co-ordination and standardisation of practice so as to streamline regulation and remove duplication. The aim is that through these duties the people and bodies listed will work collaboratively with the Health Research Authority to create a unified approval process for research applications and to put in place consistent and proportionate standards for compliance and inspection. Streamlining the approval process for research will make initiating research faster for researchers, funders and sponsors, and ultimately enable people who use health and care services to benefit from research more quickly.

Noble Lords will be aware that clinical trials in this country are governed by EU law. The EU Commission’s current proposals for a new clinical trials regulation look likely to enshrine the principle of transparency in the rules governing clinical trials at every stage, including, as the current proposals set out, mandatory publication of clinical trials summaries, not only in their technical form but in a form that ordinary members of the public will understand. We believe that that is the right direction of travel.

Given the focus of these duties on streamlining the regulatory system that the HRA has, I hope that noble Lords understand why it is not necessary to make encouraging transparency in reporting clinical trials a fundamental part of co-ordinating and standardising the regulatory practices of the persons and bodies listed and the devolved authorities. I hope that noble Lords are reassured by the fact that promoting transparency is a core part of the Health Research Authority’s main objective in facilitating safe and ethical research.

The noble Baroness, Lady Wheeler, asked about discussions with the national advisory council on health improvement drugs. Perhaps I may write to her on that topic. I hope she will forgive me for not answering now.

The noble Lord, Lord Campbell-Savours, asked about the patient information leaflet that is now mandatory within packs of medicines. The risks that are set out typically on the patient information leaflets can be derived in several ways: first, from the original clinical trials data—the noble Lord is quite right about that—but also from any data that may have subsequently arisen from the reporting system that exists. Pharmacovigilance legislation, which came into force last year, now enables the Medicines and Health products Regulatory Authority to require pharmaceutical manufacturers to report safety and efficacy data where either concerns arise or where the evidence for a medicine was perhaps less than it might have been in the first instance. So transparency can be promoted in that sense as well. The noble Lord may already be aware that the MHRA regards its pharmacovigilance responsibilities extremely seriously.

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[Earl Howe]

The MHRA, in granting a marketing authorisation to any medicine will have access to all the clinical trial data that the company has at its disposal. That is mandatory. Therefore, if the MHRA decides to issue a licence for a medicine, it will require that the full range of adverse effects is reflected in the patient information leaflet. The answer to the noble Lord’s question is yes, but he will not necessarily see a whole lot of technical data in the patient information leaflet. It will be translated into language that the ordinary patient can understand.

I believe that the Bill as drafted already gives the HRA a clear objective which requires it to take an active role in promoting transparency in research. I hope that I have given enough reassurance on these issues to all noble Lords to enable the proposers of Amendments 58 and 63 not to press them.

[Lord Warner]

My Lords, that was an interesting and rather complicated set of assurances from the noble Earl. I would like to consider it carefully and talk to my noble friend Lord Turnberg and the noble Lord, Lord Patel, before considering whether to go any further.

As an observation, if the EU directives are going in the direction of this amendment and there is a lot of concern to make sure that patients are left in no doubt that a full, frank publication of reports including the adverse consequences of that research is a prime consideration, I still cannot see why we cannot put something—whether my wording or something equivalent to my noble friend's wording—on the face of the Bill. I would like to think about that a little further and I certainly do not promise not to bring this issue back after talking to my noble friends. In the mean time, I beg leave to withdraw the amendment.

Amendment 58 withdrawn.