10 September 2019
In the United Kingdom, initiatives such as UK Biobank and the 100,000 Genome Project are now complete, and the NHS Genomic Medicine Service launched last year. With the consent of patients, local NHS trusts collect data and samples for research purposes. Each is a kind of biobank – an organised collection of biological specimens associated with computerised files, including demographic, clinical and biological data. Biobanks are an increasingly important part of research infrastructures in biomedicine and are important to realising the NHS’ desire for a more personalised healthcare system.
More recently, clinicians and researchers have been calling for wider participation in biobanking. This is because participation in biomedical research is seen as fundamental to developing more ‘targeted’ treatments, to foster a transition from a ‘one-size-fits-all’ models of healthcare to more timely, accurate, and preventative interventions. Researchers and clinicians may also need wide and inclusive participation – including patients traditionally excluded from research – to make sure that biological samples and datasets are diverse and representative.
The People Like You project is interested in these and other developments that link healthcare, research, data science, and data infrastructures. My own involvement in biobanking began before I joined the project, when I enrolled as a participant in TwinsUK based at the Department of Twin Research, King’s College London – the UK’s largest registry for twins. When my brother and I visited TwinsUK, the group collected basic biometric data, measuring height, weight, and blood pressure, also the strength of our grip and the capacity of our lungs. We gave samples of our blood, hair and spit, from which DNA, RNA, metabolites and numerous other molecules can be extracted. Our faces were swabbed in different places to test our sensitivity to different chemicals. All was recorded. We were not only enrolled, we are incorporated.
Participating in a biobank is different to enrolling in a discrete study because participants are not told exactly when and how their samples or data are used. The data stored by TwinsUK is available to any bona fide researchers, anywhere in the world. And so a biobank is not only a store of samples and data. It is also a registry or store of names and contact details, linking to individuals who have declared themselves interested in research and will give time, energy, and lots of different kinds of data. When the wind blows in the direction of studies interested in ‘personalised’ tests and interventions, this registry faced new opportunities and challenges, as did its participants.
In 2018, TwinsUK asked if I would take part in a new study called PREDICT. I was interested because it was described as a ‘ground-breaking research study into personalised nutrition’ that would ‘help you choose foods for healthy blood sugar and fat levels.’ Being involved was not straightforward. After a visit to St. Thomas’ Hospital, participants returned home and spent the next 14 days measuring blood glucose, insulin, fat levels, inflammation, sleep patterns and their gut microbiome diversity, both in response to standardised foods and each participant’s chosen diet. In return, participants would be given summary feedback on the their metabolic response. What interested me was how recruitment targeted existing members of the registry in the usual email format and their unique study number. And so it looked like any other Department of Twins Research study. But it is not like any other study.
Although Kings College London is the study sponsor and the Human Research Authority has provided the usual ethical approval, PREDICT is a large collaboration between several European and American universities, backed by venture capital investment from around the world. Tim Spector, the director of TwinsUK, is part of the scientific group that leads the group and has an equity stake in the private company called ZOE, who aims ‘to help people eat with confidence’. It is ZOE, not TwinsUK, that is processing the data that will build predictive – and ‘personalised’ – algorithms for future ZOE customers.
There is nothing nefarious or illegal about PREDICT. Collaborations between university scientists and private companies have been common for centuries. But the presentation of PREDICT’s results led me to think differently about biobanks and biobank participation in an era of personalised medicine and healthcare. PREDICT’s innovation threads together a set of historical tendencies that are important for how personalisation is seen is a desirable, evidence-based, and marketable product.
Changes in how UK universities are funded and the NHS is structured have changed the potential uses of biobanks. This is not always obvious to existing research participants (who, at TwinsUK, have a mean average age of 55 years; some of whom have been volunteers for 25+ years). In the case of PREDICT, TwinsUK assure me that all the proper licences and contracts are in place so that data can be shared with commercial collaborators and participants are given information sheets explaining how their data is used. But what does informed consent become – and ‘participation’ signify – when the purpose of a biobank shifts to include corporate interests outside the health service.
Initial results from PREDICT have been more actively disseminated in the mainstream media than in a peer-reviewed journals (summary results have been presented at a large conference in the US). Significant resources have been ploughed into garnering widespread coverage in The New York Times, Daily Mail, The Times and The Guardian. The data from the first PREDICT study has not been made available to other groups.
Begun in 1993 to investigate aging related diseases, TwinsUK started in the public sector. It still receives money from the Biomedical Research Council at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, to make translational research benefit everyone, and its other funders, the Medical Research Council, Wellcome Trust, and the European Commission, are committed to the principles of open and equitable science. But with the turn towards ‘personalised’ interventions in nutrition a fresh wave of transatlantic venture capital has become available to biomedical researchers who have access to people, resources, and data, accumulated over years of state funded work.
One facet of what Mark Fisher called ‘capitalist realism’ is the insistence that things are what they are and they cannot be another way. In biomedicine, this has affected the kinds of research that get funded and the corporate interests allowed to inform research, when and how. It is understandable that the microbiome that feeds you may be more worthy of research than the many that are not so financially nourishing. But who is keeping an eye on the opportunity costs?