The US-UK trade deal could see corporations profit from NHS patient information

The UK must neither give nor sell routinely collected patient information to the USA. The information itself is of very little value for commercial development of therapies but may be some use for estimating size of the UK market for various diagnostic procedures and drugs; going beyond that, these data provide basis for extrapolation to the USA demographic and those of some other nations targeted for sales. Yet what truly is of immense value is the means by which the UK NHS maintains its record system; this enables piggy-backing specific pre-planned studies onto routine data collection.

Demand for data is based upon a widely held but wrong preconception. This entails gathering as much data as possible and ‘mining’ it for pattern and insight the data collection was not specifically designed to provide. All this is encapsulated by the burgeoning academic field of ‘big data’ analysis. In another context, it is exemplified by the likes of GCHQ and the NSA collecting huge amounts of Internet traffic because it is available; it is an exercise in seeking needles in haystacks; occasionally ‘needles’ are located but this is an expensive and unproductive use of resource compared to targeted surveillance used to inform traditional investigative techniques involving operatives on the street and networks of informers. So it is when routinely collected health-related data are used for purposes other than, perhaps, market research; insights may arise but in cost-inefficient manner.

Analogy with GCHQ data collection and analysis bears further consideration. Firstly, the difference: NHS information is routinely collected for specific, and continuing, uses, so it, regardless of further purposes, is a necessary NHS resource whereas GCHQ’s data are a speculative resource. NHS routine data assist management at all levels including interaction of clinicians with patients. In principle, each datum is included among the routine because it helps to answer specific recurring questions (e.g. aggregation of time intervals between patient referrals and outpatient appointments). These data can assist organising and interpreting specific pre-designed studies examining aspects of NHS process and outcome, that analogous to GCHQ being handmaiden to MI5/6 and police rather than the motivating/directing force for their activities.

Assessment of outcomes from treatments can be effected to an extent by routine information gathering e.g. surveillance to identify putative adverse effects from drugs, this of considerable importance when a drug has moved beyond clinical trials into widespread use and declining urgency as years pass (in the UK ‘yellow card’ reporting has key role). However, ‘big’ data can never substitute for clinical trials when seeking to justify introduction of new therapies.

The NHS is uniquely placed, even among socialised healthcare systems, to provide a coherent backdrop for clinical trials in phases II, III, and IV.

https://en.wikipedia.org/wiki/Phases_of_clinical_research

This is facilitated by ‘joined-up’ routine information systems connecting primary, secondary, and tertiary care services and by the NHS having near universal coverage of the UK population. Thereby, clinical records from activities at all three levels greatly assist identification of subjects for recruitment into clinical trials. The clinical trial will have its own information collection to run in parallel with routine collection; this ensures consistency of data recording and coverage of matters (e.g. questionnaire data) not included in routine collection.

In the UK almost all clinical trials take place within NHS facilities and are subjected to a uniform system of ethical governance. Trials form a special interface between routine NHS work, academia, and pharmaceutical manufacturers (most of the last being privately owned). Phase II-IV trials rely on NHS infrastructure whether conducted in primary care or on hospital wards. Pharmaceutical companies provide the as yet not marketable drug and usually contribute to trial expenses. However, there are hidden costs which go unnoticed. These include physician and support staff time, service of highly specialised academic physicians and associated staff, hospital ‘hotel’ costs which might be increased by presence of trials, and increased demand on diagnostic services.

It may be perilous to assume UK trade negotiators aware of ramifications mentioned here. If they are then they ought grasp that our NHS is not merely a collection of services but rather a pretty coherent whole with interdependence of parts. Arising from its indivisible nature are its uniquely comprehensive routine information systems and capacity for engaging with clinical research. Perhaps to people whose thoughts are dominated by ownership, profit, and loss, matters discussed here are intangibles of no value to them. I doubt anybody with neo-liberal mindset would be capable of grasping their importance; anything not encompassed by markets is beyond their ken.

Apart from refusing point blank to allow sell-off of NHS assets our trade negotiators should set their own sales pitch. That revolves around US pharmaceutical and equipment manufacturers perceiving the benefits of an untouched NHS as a test-bed but operated according to UK priorities and ethical demands. In light of that, the NHS ought demand substantial discounts on US provided pharmaceuticals.

Regardless of whether the UK becomes obliged to negotiate a trade deal separate from that between the USA and EU, the forthcoming Labour government ought re-examine the national arrangements for health-related R&D and priority setting mechanisms. The current NHS R&D structure was hijacked by academics to suit their own priorities. The National Institute for Health and Care Excellence (NICE), in many ways a splendid conception, may need re-jigging and given greater responsibility, free from ministerial influence, in determining NHS priorities for use of known to be effective resources. Perhaps the R&D structure should be directed by NICE. There is possibility for vibrant win-win collaboration between the public sector NHS and private sector providers of pharmaceuticals and equipment.

A minor knock-on effect from eventually great improvement in conduct and scope of clinical trials would be no further need for anal retentives engaged in misapplying statistical principles using techniques known as formal meta-analysis whereby sows’ ears are stitched together to make a conglomerate ear rather than a silk purse.

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Released under the Creative Commons Attribution 4.0 international license.

Author’s email: atlanticcouncil@protonmail

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