|Document "He who pays the piper calls the tune?": English Abstract|
This advisory report examines the influence of financiers (especially industrial financiers) on the development of medical knowledge, and the ethical questions to which this gives rise. This also especially involves deciding on which fields of knowledge need to be developed and the actual development of that knowledge through research. The words ‘sponsoring’ and ‘sponsor’ are used below to refer to research ‘funding’ and the ‘financier’. This advisory report is based on a background study commissioned by the Health Council of the Netherlands which was conducted by Professor R. Bal et al., as well as a study of reference literature and interviews with experts. The Health Council of the Netherlands' Standing Committee on Medical Ethics and Health Law compiled this advisory report. It has been published under the aegis of the Centre for Ethics and Health (CEG), a partnership between the Health Council of the Netherlands and the Council for Public Health and Health Care. The Health Council of the Netherlands is responsible for the content.
Chapter 1 emphasises that besides industrial sponsors, other parties, such as government and charitable funds, also finance research and therefore influence the research agenda. Particular interests and compromises may also play a role in government decision-making concerned with setting the agenda and priorities for research paid for with public funds (which public interest should be given priority?). The fact that charitable funds exist for some diseases and not for others may also lead to distortions in knowledge development. Issues of this kind are also worthy of attention but are only discussed briefly in this advisory report.
Chapter 2 explores the influence of industrial sponsoring on the composition of the research agenda. It is precisely in this initial stage of knowledge development that the prescriptive
character clearly comes into focus. Industry especially tends to take an interest in subjects and develop fields of knowledge which can be expected to earn money within the foreseeable future. This is understandable, given that a business has to be profitable to ensure its continuity. The public health knowledge requirement mainly plays a role in the composition of the industrial research agenda where need coincides with commercial feasibility. Commercial feasibility and social importance are compatible but the development of biomedical knowledge would be unbalanced if knowledge development became excessively dependent on industrial research. This would also have adverse consequences for the quality of prevention and care.
The warning against lopsided knowledge development is substantiated by four case studies: drug research; research into diagnostic devices; nutritional research; public health research. Gaps in knowledge developed in these fields are delineated. Possible downsides of increased interrelatedness between industrial and clinical research are also pointed out. There is a risk that the size of the fees paid by industry may carry some weight in the composition of the
clinical research agenda and could thereby detract from the attention paid to the social benefit and quality. Possibilities and limitations of Public-Private Partnerships (PPPs) in which research projects are carried out jointly by the public and private sector are discussed. The PPP model is especially suitable for research that is likely to produce economically valorisable results in due course. The model is not a remedy for research for which the results are definitely not commercially marketable, such as research into collective public health interventions.
Unbalanced growth in biomedical knowledge
Chapter 3 summarises the main results of the four case studies. The fields of knowledge
studied are subject to all the consequences of the crowding-out effect: in fields of knowledge in which product sales and making profit play little, if any, role, development lags behind that in economically valorisable fields of knowledge, even if society has a definite need for the
knowledge concerned. The following factors play a role in this:
Industry tends not to conduct more research than is required for a new product's registration, as in the case of drugs and diagnostic devices;
Possibilities for patenting are limited in certain fields, as in the case of research into the effect of foods on health;
Demand for commercial products is sometimes too low in certain domains, such as public health.
These findings give rise to ethical questions, such as about the extent to which the crowding-out effect leads to imbalances or even unjustifiable choices and results concerning knowledge development, possible restrictions on free choice of research priorities, and the responsibility of government and other parties to make adjustments. This and similar questions would need to be discussed in greater detail.
In the process of knowledge development, the stage of conducting the research follows that of setting the agenda and priorities. International literature has shown that when a company funds research into one of its own products, the results are more favourable for the product concerned than the results of alternatively funded research concerning the same product. This distortion in favour of the sponsor's product is disturbing, also because it can harm trust in research. Explanations of why sponsored research significantly more often produces better results for the sponsor's product are found at three levels: comparisons using a placebo instead of an active drug; selective publication of research results that are favourable for the sponsor; and the selection of a favourable comparison, as when an inadequate dose of the other drug used in the comparison is administered.
The fact that reference literature revealed results favouring sponsors' products also raises
ethical questions. What implications do these results have for the conduct of the various actors, such as doctors/researchers and their institutions, science journals and their editorial staff, sponsors/manufacturers and government? The parties concerned will have to engage in debate about this.
To conclude, chapter four includes suggestions on how the identified problems could be tackled. The question always revolves around the contribution that the aforementioned actors can make to possible solutions. Government can direct some aspects but changes in the attitude of professionals and the role of industry are also important.
The potential research capacity and the number of available trial subjects/patients in biomedical research are limited. In view of the results of the case studies and the crowding-out effect, the concern is that the available capacity is not always used to generate the most urgently needed knowledge from the public health point of view. Consequently, the aforementioned actors should jointly reflect on their role and responsibility in funding biomedical research and setting the agenda and priorities. Various options for the parties concerned to combat the crowding-out effect are discussed. The parties must be persuaded that seeding trials (which are sponsored trials with the sole object of getting doctors to prescribe a registered product) produce no new knowledge and cannot therefore be scientifically justified.
Distortions in research results in the case of industrial sponsoring can be combated by preventing any research project intended to find research results that are favourable for the sponsor. The parties concerned can also help with this in their own way. The necessary steps towards achieving this have been made in recent years. If an accepted alternative treatment is available, placebo-controlled trials should be further reduced; research results that are disappointing for the sponsor should also be published; the optimum dose must be administered of the drug with which the comparison is being made.
The main assurance against distortion of this kind is the researcher's independence. Reducing conflicts of interest between the sponsor and the researcher reduces the need for the researcher to be ‘agreeable’ to the sponsor, which reduces the likelihood of bias in research results. Conflicts of interest may arise through personal reward, for example, or other forms of financial support, such as opportunities to attend congresses and payment of the associated costs. Doctors/researchers should adopt a more assertive and aloof and thereby more independent attitude towards sponsors. Another important development is that ongoing studies are increasingly being made public through trial registers, which have to report conflicts of interest and sponsoring.
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