House of Lords - Science and Technology

Select Committee on Science and Technology Sixth Report

CHAPTER 7: RESEARCH AND DEVELOPMENT

Attracting Mainstream Investigators

7.68 Training CAM practitioners in research will undoubtedly increase research activity in this area, but this will take time. An alternative approach would be to attract mainstream investigators into CAM research. This has several advantages: firstly, there would be no time-lag; secondly, such individuals would bring their experience and expertise to this difficult area; and thirdly, such a development could establish links between the conventional and complementary sectors, increasing mutual understanding.

7.69 NCCAM in the United States has been successful in attracting mainstream investigators to address some of the research priorities. The Center's Director, Dr Stephen Straus, who himself is an eminent and successful mainstream scientist, told us: "The more immediately successful route is to seduce your best scientists to join the enterprise, by funding them to work in areas they are already expert in and, perhaps, inherently interested in as well. Our largest funding has been going to our best mainstream investigators. We also need to bring complementary and alternative medicine experts and practitioners into this. That is hard because — except for some very isolated aspects within the chiropractic and the acupuncture communities in the United States and some experts in botanicals — there is not a research tradition in those communities" (Q 1734).

7.70 The MRC were also enthusiastic about this approach to kick-starting CAM research. Professor Sir George Radda, Chief Executive of the MRC, told us: "The first and, perhaps, most critical thing is that we do have a number of very distinguished people who are, if you like, part of the Medical Research Council who actually take complementary medicine seriously and who are interested in taking it forward in some way. Professor Tom Meade, of course, has done one of the pioneering studies on back pain and chiropractic. We have a number of other scientists who have served on various committees that are concerned with complementary medicine…I think people are interested in making sure that not only do we contribute to the debate but that we will be able to do something serious about making sure that the way complementary medicine is used is effective and well-researched" (QQ 1085 & 1086).

7.71 Sir George also explained how the MRC may be able to aid such associations: "We do have the mechanism to encourage those sorts of collaborations. For example we have had, for three years, the co-operative grant system where we encourage people to tackle individual major problems in a way that different scientists can contribute different aspects to that. It would be perfectly reasonable, for example in a co-operative on asthma, to include a component grant application from somebody who wants to develop a study on the use of complementary medicine in asthma, and it would actually then be done in the context of what else is going on in the way of research in asthma, rather than as an isolated project which, perhaps, would not stand up in the long run" (Q 1087).

Research Funding Sources

7.72 Funding for healthcare research, including CAM, is available from a variety of sources. These include:

(ii) the medical research charities

(iii) commercial and industrial sources

7.73 We have considered the prospects for CAM research under each of these options in turn.

The Government

7.74 In their written evidence the Department of Health explained that the Government supports health research in the United Kingdom through a number of routes outlined in Box 11. The Government were keen to emphasis that CAM projects may stand a better chance of funding if they come in under areas that the Department of Health are making a priority. Professor Sir John Pattison, Director of NHS Research & Development, told us: "I think the Government has set some challenging priorities for R&D and granted some extra resources for that - but it is in specific areas such as cancer, mental health, cardiovascular disease and coronary heart disease in particular, and the elderly and children. It would be in those areas that we would particularly welcome and look at proposals for complementary and alternative approaches. Just as an example, we are about to fund a study of reflexology in patients after surgery for early breast cancer. I think that reflects that there are opportunities for CAM professionals and practitioners to come through with proposals to get funded through our systems" (Q 1866).

Box 11

Government Funding Options
—  Medical Research Council.

—  Department of Health 'Policy Research Programme' (PRP) - This aims to provide a knowledge base for health services policy. PRP has supported two CAM research projects through the Sheffield University Medical Research Unit.

—  NHS Research and Development Levy - Money is allocated following evaluation of bids competing against national criteria. In April 1998 £360 million was allocated in the form of three- year funding arrangements. One CAM bid was successful in April 1998 and received funding of £61,650 for its first year.

—  NHS Executive Research and Development Programme - Work is commissioned directly from Universities on behalf of the NHS. There are three main national programmes run under this budget: the Health Technology Assessment Programme, the New and Emerging Applications of Technology Programme and the Service and Delivery Organisation Programme.

—  Methodology Programme - Supports all the other programmes by commissioning research into methodology. Several projects of relevance to CAM research (although not directed solely at CAM research) have emerged from this programme.

—  Research funded by NHS Regions - Regions can identify their own priorities 12 CAM projects have been successful in obtaining funding through this route.

—  Higher Education Funding Councils grants to universities - For those researchers based in academic institutions.

Source: Department of Health written evidence (P 101)

The Medical Research Charities

7.75 The structure of the medical research charities means that CAM is often in a difficult position to compete for their funds. The AMRC point out that "Most medical charities spend the greater part of their money on understanding the mechanisms of disease, not efficacy. Usually, efficacy is a smaller part of the work of medical charities" (Q 1198). They also explained that as most medical charities are relatively small and only focus on one or two specific disease areas, it is relatively difficult for them to participate in large-scale, non-disease-specific research funding, which is the usual nature of CAM research. "In this field very few medical charities are general charities. Very little CAM research would be disease-specific. If most of the smaller charities are disease-specific the research simply does not fit"(Q 1176). One important exception is the Wellcome Trust which, like the MRC, will fund research in any area of medical science.

7.76 Currently the AMRC has no plans for special initiatives into CAM: "We are feeling our way as to the role in CAM that might be played by AMRC. AMRC does not have any of its own funding for research. Therefore, the Association is a facilitator in helping charities to spend their money as effectively and in as targeted a way as they can. What we will do is probably take the first step by establishing a special interest group within AMRC to look at CAM research…For it to work it is very important for AMRC to work with the professional body concerned…Partnership with the professional body is important and must be developed in CAMs" (Q 1175).

7.77 As another example of the perceived need for more research into CAM accessed by their patients, the Arthritis Research Campaign has developed an initiative to encourage more CAM proposals with an appropriate assessment mechanism to ensure these will address relevant questions with high-quality proposals.

7.78 There are some small charities dedicated to CAM but, as the RCCM told us, they rarely have the resources to fund research: "Smaller charities - and we are one of them - in the health arena almost always focus not on research but on support for clinics or disadvantaged groups" (Q 117).

Commercial and Industrial Companies

7.79 For much of conventional medicine it is the large pharmaceutical companies which fund clinical trials. However, in CAM there is very little industry-based research. This is mainly because many CAM remedies are natural products which cannot be patented, and hence companies that research them cannot guarantee that they will benefit financially from the research. Dr Stephen Straus, Director of NCCAM in the USA, explained the situation he has encountered with industry: "There is woefully little investment on the part of private industry. They have yet to discern that there is a financial advantage for them to do so…I am attempting to encourage them to help invest in studies of the effectiveness of their products as well. By and large, they are not doing so" (Q 1712).

7.80 The Wellcome Trust pointed out that, despite the lack of patents on CAM products, industry does make substantial profits in this area, and Wellcome's view is that some of this should be ploughed back into research and development. We agree. They told us: "One interesting matter referred to by Dr Mike Dexter, the Director of the Trust, in his introduction to a workshop on CAM run by the Trust, was an article in The Times just prior to that meeting on 2 March which suggested that £500 million in the United Kingdom was spent on complementary health products. The pharmaceutical industry would spend some 25 to 28 per cent of the money from sales of conventional medicines on research and development. Therefore, one might think that in CAM health products perhaps £150 million a year could be spent on research and development" (Q 1136). With no patent protection available for most of CAM such figures may not be easily obtainable in this area. Nevertheless it should be noted that a Research and Development budget of 5% of commercial turnover on CAM products, if this is indeed £500m per annum, would yield £25m per annum. They also suggested that a new regulatory framework for CAM products might encourage industry to invest in the area: "Legislation such as regulations governing pharmaceutical products would help to promote research into CAM products. Of the three major funders of biomedical research in the United Kingdom in conventional medicine, the pharmaceutical industry is by far the biggest supporter. The Government and charities come lower down the list. We believe that perhaps a look at the legislation and regulation of these products may also have a safety spin-off but also release money for further research and development" (Q 1136).

7.81 We therefore recommend that companies producing products used in CAM should invest more heavily in research and development.

Pump-Priming and Ring-Fencing

7.82 One method of kick-starting research into CAM is to pump-prime or ring-fence research funds. Ring-fenced funds are funds specifically directed into a defined area of research, and are awarded to applications from that area without having to compete with applications submitted from other areas. Pump-priming differs from ring-fencing in that funds are only dedicated to the area for a limited period of time to help develop the infrastructure needed to underpin substantial high-quality research which will then attract more substantial funds.

7.83 The issue of ring-fencing and pump-priming is controversial and the views of our witnesses on this subject were polarised. Several witnesses suggested that without ring-fencing or pump-priming, the research infrastructure for CAM will remain poor, and that bias and lack of expertise (see 5.38 above) on behalf of research proposal referees will continue to prevent grants being awarded in the area, with the result that CAM research will never be adequately supported. However the alternative view, articulated by several other witnesses, is that ring-fencing and pump-priming are inherently unfair, and that research proposals should all be considered on merit. It is further argued that, by designating funds for a specific area, many problems may arise largely due to an imperative to spend funds on research irrespective of its quality or importance.

THE LESSONS OF NCCAM

7.84 Research funds have been ring-fenced for CAM in other countries, most notably in the USA, where NCCAM received $70 million this year and expects to receive funding of between $80 and $100 million next year (Q 1712). This, however, represents less than 5% of the total budget of the NIH. The history and experience of NCCAM confirms the possible beneficial effects of ring-fencing of research funds in this area.

7.85 NCCAM was only established in 1999: it was preceded by the Office of Alternative Medicine which was set up in 1992. In the first few years of the Office of Alternative Medicine, funding was much lower than that which NCCAM receives and the success of that office in generating good quality research was perceived to be poor. For example, the Academy of Medical Sciences told us that the office had run into serious problems, as many of its research grants resulted in papers being written that were not published or were not published in reputable peer-reviewed journals; hence, they argue against ring-fencing. We asked Dr Stephen Straus to comment on these failures and on the history of his Center: "The first ring-fenced funding, as it were, for complementary and alternative medicine began in 1992, with an allocation of $2m to the then Office of Alternative Medicine, which was in the office of the Director of the NIH. The attempt was for that small office to attempt to leverage those funds and convince the other Institutes to increase their support. The office also funded a number of very small projects. The average funding for each of those projects was about £20,000 (i.e. $30,000), which is somewhat less than one-tenth of the usual size of an NIH grant. It was not surprising that that amount of funding yielded very little in the way of powerful science" (Q 1718).

7.86 However, he said that now NCCAM's increased funding and experience means that they are able to conduct reputable trials: "I would say the best opportunity we have had is to have the independent authority to issue grants at the standing NIH level. We believe we are investing in the kind of research now that will be in the best journals. I would be stunned if our study of St John's Wort, that has just recently completed enrolment, would not be accepted in, perhaps, the British Medical Journal. Frankly, I would be, personally, gravely disappointed if we do not do far better" (Q 1718).

7.87 Dr Straus went on to elaborate on how NCCAM had managed to improve the quality of its research. "There were approximately 40 small grants given from the Office of Alternative Medicine in its first few years. With the creation of NCCAM in early 1999 several things were done. First of all, we have invested in creating research capacity, by funding eleven centres to date. Two of the centres fund botanical research. We are funding nine centres around different diseases and conditions. Each of those centres is funded with $1.5 million a year for five years. We are developing research capacity through those centres. We have called for and are now beginning to fund, for the first time, major research, training and curriculum programmes in institutions around the United States. We are attempting to inspire young individuals who seek careers in research to enter the research area within complementary and alternative medicine by working under the mentorship of outstanding investigators. We are funding approximately 80 grant applications at this point, averaging about $250,000 to $300,000 each. We are funding five large, multi-centre, placebo-controlled, randomised clinical trials. Our first large studies will not be completed for little under a year. Our small developmental projects are now entering their second year. It is still premature to know what our funding has bought. We have encouraged very good people to join our enterprise" (Q 1719).

7.88 Dr Straus acknowledged that ring-fenced funding is always a controversial matter in science: "At the NIH we believe, as you do here in the MRC and other leading research funding authorities, the best science is investigator-initiated application submitted by the best individuals in pursuit of the best ideas" (Q 1712).

7.89 However, he also told us that "The funding at the NIH, which this year totals nearly $18 billion is, in many regards, entirely ring-fenced in that it is allocated and apportioned to institutes on the basis of the perceived public health needs in those areas…Our funding is ring-fenced in the broadest sense. It is in pursuit of a broad field and a broad set of ideas" (Q 1712).

7.90 Dr Straus explained the advantages of ring-fenced funding at NCCAM, including the fact that the money does not have to be used just to fund particular projects but can be used to strengthen the research infrastructure: "We have the ability within NCCAM to target our resources in pursuit of the best opportunities. We are building a research infrastructure and capacity by funding centres. These are things the other Institutes would not tend to do for complementary and alternative medicine. We are funding research training and curriculum development from pre-doctoral through career awards. We could invest in areas that are still scientifically unformed but which are matters that are still very much in the public interest. As you know, homeopathy is less well-established in the United States than it is here. We do not have the equivalent of the NHS homeopathy hospitals. We have the ability to fund research. Through the peer review process, which manages all of our grants and applications, we attempt to select the best. It is ring-fenced, in a sense, but it is in response to public need" (Q 1712).

7.91 He went on to elaborate upon how NCCAM decide which applications to fund and explained that scientific merit is considered as one of several important factors: "[Judgements are] made on scientific grounds, while being conscious of the imperatives that we have. Let me explain further. The applications that are received are peer-reviewed, as all applications are to the NIH. They are scored accordingly. It is my responsibility to meet with an advisory council three times a year to review the applications and the scores they receive. My council can, in their best judgement, not change the scoring, but they could say "although this had an average score we feel this is a very important area, or a less important area" (Q 1716). In other words, they can prioritise to an extent.

7.92 Dr Straus also explained how he believed the NIH managed to avoid ring-fencing distorting the overall priorities of health research: "Over the past decades public advocacy has grown in strength and impact…Every important condition has its advocacy organisations that are calling for support for their work. To some extent, there is an equalisation through the process. The US Congress responds to calls on the part of the public, but also to our testimony and our best judgements as scientists as to where the opportunities are greatest and investments are most likely to prove profitable. There is a danger that if that was the only mechanism by which large funding decisions would be made, then there would be a distortion. Fortunately, that is not the only mechanism. Even within that mechanism those are general guidelines. The NIH is still able to fund the very best peer review research" (Q 1714).

ATTITUDE OF UK RESEARCH FUNDING BODIES

7.93 The issue of ring-fenced funds has been raised as a means of boosting CAM funding in the United Kingdom in several submissions. Professor Edzard Ernst, who holds the CAM Chair at Exeter University (P 229), points out that ring-fencing has been very successful in other countries (e.g. Germany and the USA) and could be encouraged by the NHS, the MRC, Primary Care Groups and Trusts, and industry. However our discussions with the main research funding institutions in the United Kingdom reveal little enthusiasm for ring-fenced funding for CAM research.

7.94 The MRC do not believe that they should ring-fence funds for CAM. They told us that they intend to continue to judge CAM grant applications by merit in competition with all other grant applications: "The MRC believes that there is no justification for a different approach to research into complementary therapies compared to conventional therapies. At present, there is generally insufficient evidence to prioritise within or between evaluations of conventional and complementary therapies. In the absence of well-developed research proposals, we therefore consider the case for increased research funding for CAM has not been made. Nevertheless, the MRC will continue to welcome applications for support to evaluate complementary therapies. These will be judged case-by-case on their own merits, in competition with other calls on MRC's funds" (P 139).

7.95 One of the MRC's main arguments against ring-fencing funds for CAM is that, given that one of the main problems within CAM is the poor quality of CAM research proposals, ring-fencing might lead only to more poor quality research. They suggest that there are better alternatives to ring-fencing to improve CAM research: "Throwing money at bad science does not help anybody. So I am not for ring-fencing. Whether one should have an initiative, or if encouragement is sufficient, I do not know. In view of what we hear, that the research capacity is not there yet, it seems to me that you need to start training and you need to start getting people who themselves would like to do research in complementary medicine to acquire good research training. That is, train people in statistical aspects of medicine and train people in how to evaluate evidence and so on. Then we could, perhaps, build on that (Q 1095). It is a chicken and egg situation and I believe that people have to come first before you can do the research. You need to target individuals who can do research and say to them: 'this looks now an important enough issue: could you put together a proposal?' That is one way of bringing in the practitioners of complementary medicine as part of such a proposal. That they can, through an individual like Professor Meade, learn how to do this sort of research" (Q 1097).

7.96 Although the MRC were against ring-fencing, they were not against prioritising certain research areas: "…If you say that there are some very, very urgent problems which require proper scientific study that lead to a long-term solution, I am sure we would be very willing to consider it. If it is a matter of comparing one treatment with another, that is more a Health Department issue. With that proviso, there is no reason why we could not respond if there was a real demand from the medical, scientific, or whatever, community for something like that" (Q 1099).

7.97 The Department of Health told us that they also believe that CAM research must be considered on the same basis as conventional research: "The Government views research into CAM in the same light as that into all other branches of medical practice" (P 113).

7.98 The Department of Health fund research through several different programmes and organisational structures (as reviewed in Box 11) and some of these mechanisms allow the setting of priorities: "Priorities for R&D are set from time to time to take account of Ministerial priorities and priorities for health and social care, and CAM research is considered as part of this" (P 114). They did describe one time-limited funding programme that had resulted in some CAM research: "The National Cancer Programme contained a specific priority on the comparison of cost-effectiveness of different psychosocial interventions, including CAM therapies. One CAM project was funded: a randomised controlled study of the effects of reflexology on mood, adjustment, quality of life and patient satisfaction" (P 113). There is also scope for prioritisation within local NHS R&D budgets: "Regional R&D budgets are intended to allow Regions to identify and support local priorities and build research capacity. As part of a Commissioned Research Initiative, South West Region issued a specific call for proposals in May 1996 into: Which specific CAM therapies are effective for which conditions? Which specific conditions may benefit from CAM? What are the resource and other consequences on the NHS where CAM is not provided or used? As a result of this call, two projects were funded: a project - now complete - to evaluate the effectiveness of acupuncture in defined aspects of stroke recovery (£179,903), and a multi-centre study of acupuncture for tension headaches (£22,169)" (P 113).

7.99 As discussed in paragraph 6.81 Professor Sir John Pattison, Director of NHS Research & Development, and Yvette Cooper MP, Parliamentary Under Secretary of State for Public Health, both encouraged CAM proposals to try to come in under current NHS initiatives, such as those prioritising cancer research. However, despite these limited initiatives, the general position of the Department of Health is not one that favours ring-fencing or pump-priming: "Within the NHS R&D programme there has been relatively little ring-fencing in any area. The arguments against ring-fencing are robust. I believe that it would imply a dual standard and at the end of the day there must be research that is robust enough to give clear answers, By relaxing the standards of rigour it is too easy to make research investments that do not pay off" (Q 5).

7.100 We also talked to non-governmental bodies about their attitudes to dedicated funding. The Wellcome Trust told us that, despite their recent conference on CAM and their belief that it is an important area: "CAM research is not ring-fenced, and it is probably our policy not to do that" (Q 1104). Although in the past Wellcome did ring-fence, they explained that "we now go for open competition and try to reduce the number of schemes that we fund by bringing them together so that all who apply have an equal opportunity" (Q 1104). The Trust do have some directly-managed initiatives, for example on genomes, but they saw this as an unlikely prospect for CAM (Q 1168).

7.101 The AMRC explained why they did not believe that ring-fencing was an option for medical charities: "We would resist the idea of any medical research charity being perhaps forced to ring-fence money for a particular speciality. In a way, that money is already ring-fenced for specialities or diseases. That is not a comment on the need or not for Government to ring-fence; it is a fact of life for charities" (Q 1194).

7.102 It is our opinion that despite the Department of Health and the MRC's reservations about dedicating funding, something must be done to build up the research capacity in CAM; otherwise the poor state of research and development in this area will continue. The lessons of NCCAM in the USA show that, if funds are there, experienced researchers will apply for them, and with sufficient investment high-quality CAM research can be achieved. NCCAM's annual budget is about $68.4m: this is 0.4% of the total budget of the NIH. Without dedicated funds, CAM will struggle to attract high-quality researchers and it will be hard to build the infrastructure for the research that needs to be done in this area to protect the public. In our opinion it will not be long before CAM research will be able to compete against other bids for funds in a way that it cannot currently do. We recommend that the NHS R&D directorate and the MRC should pump-prime this area with dedicated research funding in order to create a few centres of excellence for conducting CAM research, integrated with research into conventional healthcare. This will also help to promote research leadership and an evaluative research culture in CAM. Such funds should support research training fellowships and a limited number of high-quality research projects. This initiative should be sufficient to attract high-quality researchers and to enable get them both to carry out large-scale studies and to continue to train CAM researchers in this area within a multi-disciplinary environment. We believe ten years would be sufficient for the pump-priming initiative as, for example, in the case of some MRC programme grants and various training and career development awards available in conventional medicine. The Association of Medical Research Charities may also like to follow this example.

Co-ordinating the Development of CAM Research

7.103 The discussions in this chapter show that there are many issues to take into account when considering how to increase research into CAM. Several of our witnesses have suggested the need for a co-ordinating body to promote research in this area. For example Dr Howard Scarffe of the Wellcome Trust felt it may be sensible to have an "over-arching organisation to co-ordinate research strategy" (Q 1136). He went on to suggest that "the Foundation for Integrated Medicine may possibly be an appropriate organisation to assume that role" (Q 1136).

7.104 A body of this sort could take on various roles to aid CAM research:

(ii) To advertise funding programmes;

(iii) To act as an information centre on research training opportunities and to advertise specific opportunities in this area;

(iv) To advise on drafting grant applications;

(v) To disseminate research findings and co-ordinate research strategies.

7.105 FIM told us: "I think our central role at the Foundation in relation to research is very much encouraging others to do it. That might involve the Government, it might involve the Wellcome Trust; it certainly does involve the research charities which are responsible for nearly £500 million of research, so we see our role as very much one of influencing and helping. Part of that may involve us directly funding some research; we do have a small research programme ourselves but it needs to be seen within that wider context" (Q 93). FIM are currently drafting a national strategy for CAM research.

7.106 The RCCM also believe that there is a need for a national strategy for CAM research. "Given the public and professional interest in complementary and alternative medicine, a co-ordinated strategy supported by public funds requires careful consideration and debate (Q114)… In the absence of a comparable R&D infrastructure, CAMs do not have a national strategy, so any research will be carried out in isolation, will be ad hoc and will not address key priorities. So we feel that a national strategy is required" (Q 118). They believe that this national strategy should be "developed and co-ordinated by a body that is independent of but accountable to Government. It should have relevant and appropriate multi-disciplinary representation from both the CAM field and the conventional field, and appropriate representation from health service researchers, and there is a current debate in NHS R&D around a lack of good health service researchers. It should be chaired, or led, by someone who is impartial and not immersed in a particular tradition, and it should establish priorities for CAM research, perhaps through a consensus approach drawing on the multi-disciplinary field. It should commission, fund and monitor CAM research including the quality of the research that it is commissioning" (Q 352).

7.107 To maintain impartiality and fairness, but not at the expense of quality, FIM is in a particularly strong position to take on these tasks with resourcing from the Government and possibly the charitable sector. Joint research between different grant-awarding bodies is gaining acceptance in the United Kingdom and therefore we see no reason why, with appropriate safeguards and accountability in place, the Research Councils and the Department of Health could not drive forward CAM research by operating in this way, rather than by simply awarding individual grants. There already exist examples of such mechanisms in the concordat that the MRC and the Department of Health have developed for joint working, and the joint initiatives between the United Kingdom Government and the Wellcome Trust in the Joint Infrastructure Fund and Joint Proposal Funding Initiative.