The University of Sydney has just announced it’s establishing a new research position in integrative medicine funded by a A$1.3 million donation from the Blackmores Institute. It says the Maurice Blackmore Chair in Integrative Medicine (a blending of evidence-based conventional and complementary medicine) will add to the university’s current research in the field.
But does the move give rise to questions about whether research linked to industry will be compromised? In this Viewpoints, Paul Komesaroff argues working with industry doesn’t have to be a problem for universities while Ken Harvey says there’s a better way.
Paul Komesaroff: The propriety of industry support for research in universities has long been debated. During the Vietnam War, for instance, controversy was generated in the United States about the role of universities in developing chemical and anti-personnel weapons. And, more recently, relationships with pharmaceutical companies have come under close scrutiny.
The issue has become still more complicated by the transformations universities have been forced to undergo over the last few decades.
For better or for worse, universities are not ivory towers and researchers are not disinterested searchers after truth. Scientists are motivated as much by personal ambition and advancement as they are by the pursuit of knowledge and derive their incomes from ever-shrinking grant sources that are themselves controlled by government and subject to partisan social policies.
Universities now operate as businesses and have limited commitment to the traditions of radical critique. And there’s no doubt direct links between universities and industry funders pose significant risks. These include the possibility of the research agenda being distorted in favour of commercial interests, of unpopular viewpoints being suppressed for fear of offending benefactors, and of the very concept of free inquiry and possibility of independent scholarship being placed under challenge from crudely commercial managerial imperatives.
Indeed, there’s ample evidence that all of these possibilities have to some extent been realised. But this doesn’t amount to an argument that all relationships between industry and universities should be proscribed.
What it means is that such relationships must be carefully regulated according to clearly defined values. There must be irrefragable guarantees of independence, both from industry funders and from university management themselves. There must be vigorous debate about where the limits to external support should be set and which industries should be excluded altogether.
Universities should adopt clear charters and codes of ethics that guarantee their founding ethos, which should be genuinely enforceable.
The case of complementary medicine raises special issues. Mainstream medicine remains well represented in the universities while only limited research funds are made available for complementary medicines, in spite of the fact that a high proportion of Australians use these products on a daily basis. The conduct of high-quality research in this area is undoubtedly in the public interest. Risks can be mitigated if the guidelines suggested here are followed.
Universities are not pure centres of thought, and nor should they be. Constructive engagement between educational institutions and industry is desirable, but it needs to be subject to rigorous controls. This applies to all research partnerships, including those with the pharmaceutical and complementary medicine industries, and other commercial entities.
Regulatory processes should include clearly articulated principles that define what is acceptable and what is not, along with mechanisms for public scrutiny and effective enforcement. The task may be a complex one, but there is no reason why it’s unachievable.
Ken Harvey: It’s my view that this question cannot be answered without first addressing fundamental problems in the Australian regulatory system of complementary medicines, which is what is at stake in this instance. The vast majority of complementary medicines on the Australian market are listed by the Therapeutic Goods Administration (TGA) rather than registered. Listed products are not evaluated by the TGA to see if they work.
While the product’s sponsors, which are usually its manufacturers or licensed local distributors, are meant to hold evidence of efficacy, this is often found to be unsatisfactory when complaints are made. Or when the TGA conducts limited post-marketing reviews. In addition, there are no effective sanctions to deter such behaviour.
The end result is a market flooded with products of dubious efficacy promoted with hype and celebrity endorsement rather than scientific research. Indeed, a company that has financed the research necessary to produce evidence-based (TGA registered) complementary medicines complain they haven’t garnered a useful return on their investment as the public doesn’t understand the difference between listed and registered products.
But what does this mean for the incumbent of the Maurice Blackmore Chair in Integrative Medicine? First of all, she will need to be aware that the majority of complementary medicine products in the Australian marketplace are not evidence-based. And that includes those of the company funding her chair.
This could cause a number of potential conflicts of interest. The company concerned may have expectations that the research conducted will validate its products, which it may not do; there may be subtle pressures on researchers from vice chancellors and university business managers to not be critical of complementary and alternative medicine products so as not to upset the funder; researchers may be tempted to game their work to produce pleasing results by, for instance, testing the effect of multivitamins on cognition by performing numerous psychometric tests on small numbers of subjects. This increases the likelihood that one or two will prove “statistically significant” by random chance.
And then there’s the danger that the funder may magnify or cherry-pick positive results – or both – without waiting to see if these can be replicated.
Companies may also refuse permission to publish negative results. They will almost certainly use their association with the university for marketing purposes. And this may cause problems for the university if the company’s views on marketing differs from those of regulators.
Most of these potential problems can be minimised by clear agreement that the university will be in complete control of the research questions, the methodology, and ethics approval and publication rights. But Professor Edward Ernst’s experience at Exeter University provides a cautionary tale of the problems that can emerge.
From 1993, Ernst held the first chair of complementary medicine in the United Kingdom. His research showed that while some complementary modalities worked, many more didn’t. In 2005, Ernst dismissed as “complete misleading rubbish” a report commissioned by the Prince of Wales, which claimed complementary and alternative medicine was cost-effective. His university investigated him after a complaint about his early disclosure of the report’s contents and his funding dried up despite the lack of findings against him. He retired early and his department was closed.
Paul Komesaroff: I agree with many of the concerns about the regulation of complementary medicines expressed by Ken Harvey. The current system encourages the sale of products that have been subjected to inadequate testing and tolerates inaccurate or even false promotional claims about them. And the distinction between listing and regulation of medicinal products has generated perverse incentives that operate against public interest.
But surely this is an argument for more research, not less – for increased support for the generation of high-quality data, and for open, critical reflection and debate. It’s an argument in favour of bringing complementary medicines in from the cold so they can be subject to the same standards and scrutiny as pharmaceuticals and other fully regulated medicinal products.
I also agree that research funding poses risks, including those associated with conflicts of interests, pressure on researchers and the institutions themselves. And there’s the risk that funders may use their support to bolster commercial activities, and may even seek to suppress unfavourable research outcomes.
These risks are real but they are all also foreseeable. And in each case, it is possible to devise effective strategies to avert them.
It’s in the public interest for complementary medicines to be subjected to rigorous research and for reliable, trustworthy information to take the place of exaggerated and unsubstantiated claims. One of the most effective ways in which this can be achieved is through careful, properly regulated, fully transparent relationships between industry and academia.
If the chair at the University of Sydney satisfies these criteria it should receive our full support.
Ken Harvey: The best way for a company to sponsor high-quality research into complementary medicine without any possible conflict of interest is for them to provide a hands-off, anonymous donation to the National Health and Medical Research Council (NHMRC) that would add to the existing (small) pool of money provided for competitive, peer-reviewed research grants in this area.
The NHMRC has already researched some complementary medicine modalities and has also provided educative material for medical students and practitioners.
And the report of the Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies (currently with the health minister) will provide additional information on the evidence base of many more complementary or natural therapies.
Hands-off industry support to the NHMRC is a better way to proceed than financing an eponymous chair because it still ensures we’re researching complementary medicines but mitigates all the risk that the latter entails.
Paul Komesaroff is a former colleague of Dr Lesley Braun who is now Director of the Blackmore Institute.
Dr Harvey has accepted travel expenses only to talk about problems of complementary medicine regulation to pharmaceutical companies and industry associations. He has also been paid travel expenses and sitting fees for his involvement with government inquiries and working groups concerning the promotion and regulation of complementary medicines. He is regarded by some section of industry as a serial complainant.