By Invitation. Public funding of scientific research benefits consumers

Recently, the ASPREE (ASPirin in Reducing Events in the Elderly) trial was published online in the New England Journal of Medicine addressing the question of whether healthy older people should be taking low-dose aspirin to maintain themselves in good health. For those without previous heart disease or a stroke, the answer was clearly no, aspirin is as likely to be harmful, as beneficial, in this age group.

ASPREE provided an answer to a question whose importance has been recognised for at least 30 years. During this time, many millions of healthy older people have taken low-dose aspirin in the belief that it may reduce their risk of heart attack or stroke or prolong their life. In doing so, they have experienced an increased risk of bleeding which, although uncommon, can be serious.

One reason why this question remains unanswered was because aspirin is not a patented drug. Therefore, there is no commercial imperative to fund such a study. And so it becomes clear that a question such as this can be addressed only through public funding.

The problem, however, is that studies such as ASPREE are expensive undertakings, typically costing tens of millions of dollars. When funded commercially, it is in the hope of gaining a substantial commercial return. It is rare for government research organisations to have this level of funds to support such a study.

In the case of ASPREE, it was only the foresight of the US National Institute of Ageing and the Australian National Health and Medical Research Council that allowed this trial to be conducted.

More such trials needed

There are other important public health issues, many relating to the use of off-patent drugs, where there is no likely commercial sponsor. Some of these older drugs were approved for marketing on the basis of evidence that would now be regarded as substantially inadequate.

A similar issue has been recognised in the US with the establishment of PCORI (Patient-Centred Outcomes Research Unit) , funding organisation targeting comparative effectiveness studies.

In view of the challenges of finding public funding, it will be important to identify and prioritise other similar questions concerning the risks and benefits of established drugs. Given the rapid ageing of many populations, it will be particularly necessary to support studies of the use of established drugs in older people who are more affected by adverse effects of pharmaceutical agents. In many cases it is drug regulatory agencies who are most aware of these data deficiencies and should bring these to the notice of clinical researchers.

In the longer term, it is likely that the risks of leaving virtually all of the funding of major trials to industry will be increasingly recognised. Although the quality and integrity of such studies is now highly regulated, there are still subtle ways in which their focus may be directed towards commercial gains rather than public good.

Widespread publicity about conflicts of interest in the reporting of results is also a continuing concern despite requirements by most journals and conference organisers that these are made explicit.

These are just some of the reasons why many more public good studies similar to ASPREE will be required, especially in priority areas such as prevention trials (with their requirements for large patient numbers followed for some years).

The funding of these endeavours will require new and innovative approaches to the development of funding consortia. Given that most issues are likely to affect prescribing in many countries, consideration should be given to the development of international funding consortia.

By spreading relevant trials over multiple countries, the financial burden on each country would be reduced and the burden of recruitment reduced. Although ASPREE involved only two countries, this shared approach may provide a guide as to the conduct of future, large-scale, public good clinical trials.

John McNeil  is the head of Monash University’s Department of Epidemiology and Preventive Medicine, Australia.

Views expressed are personal

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