Commercial research in the UK’s National Health Service may involve the use of taxpayer-funded resources to support business objectives but it brings multiple benefits beyond swelling pharmaceutical company margins, argue stakeholders from within the service, medical research charities, government and the National Institute for Health Research (NIHR).
As was noted at the outset of a recent online debate organised by The Guardian, The NIHR saw a 78% increase in commercial research studies conducted through the NHS in 2010-2011. This is undoubtedly good news for the UK’s continuing viability as a research base in the face of global competition. However, it does raise questions about whose interests these trials really serve.
One participant in the debate, for example, acknowledged the need to support commercial research so that new medicines would keep flowing through the pipeline.
But, he added, “I wouldn’t want NHS services to be compromised by this support. I don’t want to be paying three times – once in taxes to support commercial research in the NHS, again in taxes to subsidise prescriptions of expensive pharma products, and on top of that to pay for my own prescription when I need one”.
Full cost to industry
For one thing, noted Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, involving industry in NHS research is a practical necessity. Nor, he argued, does it impose any direct cost on the health service or, by extension, taxpayers.
Commercial Research in the NHS “is at full cost to industry, and in fact the NHS makes a margin on all commercial research which can be invested in patient care, so there is no cost to the NHS for commercial research”, Sheffield commented.
With the estimated cost of developing a prescription drug running at up to £1 billion, the public sector simply “does not have the resource to invest that heavily in drug development, and so we need private finance to deliver this work”, he added..
“The more development in the UK, the better for the economy and hence the better for tax return and more money for public investment in the NHS. The cost of many drugs available to the public in the UK has to be paid for through subsidisation from taxation, otherwise many patients would not have access to state-of-the art treatments.”
Always the patient
For Dr Peter Bridle, programme director of the Avon PCT (Primary Care Trust) Research Collaborative and clinical lead for dementia at NHS Bristol, the focus of research – whether paid for by industry, charities or the NHS – “is always the patient”.
In placebo-controlled studies, it is “quite possible that there will be no immediate benefit for the individual from the trial”, Brindle pointed out. “However, in more general terms, patients that are cared for by research active institutions tend to do better than patients who are not”.
This may be due to the “culture of quality” that research brings to an NHS organisation or the greater attention patients get when they participate in studies, he suggested. Moreover, “research-active organisations may attract the very best medical and nursing staff”.
The idea of recompensing patients financially for their contribution to clinical research raises “all sorts of ethical questions”, Brindle added.
“If money is a key driver for patients, then possibly those that are most desperate for money will end up in studies that they might otherwise choose not to do. Also paying participants will affect the generalisability of the research findings.”
Best standard of care
Professor Peter Weissberg, medical director at the British Heart Foundation, underlined the point about patients receiving the best standard of care available if they took part in trials, commercial or otherwise.
“This is because any new drug or treatment strategy has to be compared with current best practice. Hospitals are not always in a position constantly to monitor standards of care in their various departments, but if you are in a clinical trial your care will be monitored extremely closely as a requirement of the trial protocol.”
According to Dame Professor Sally Davis, chief medical officer and chief scientific adviser to the Department of Health, there is “a huge benefit” to patients from commercial research being conducted within the NHS.
“It gives early access to cutting-edge treatments and technologies, and ensures best care for patients throughout the study.”
In diabetes care, for example, it is important to educate and motivate patients, observed Gerry Rayman, who heads up diabetes research at Ipswich Hospital (part of the Diabetes Research Network).
As this often requires time that may be in short supply within NHS clinics, the extra resource available through clinical research “is invaluable. People recurited into studies often use this period to kick start tem into re-engaging in their diabetes care. It is well know that diabetes control almost invariable improves in the placebo group”.
Indeed, Weissberg contended, it is “hard to think of commercial trials that haven't delivered patient benefit. Even if the new treatment turns out to be less good than the current best available, that is something worth knowing. Trials that prevent potentially dangerous treatments from being widely adopted by practitioners are just as valuable as those that demonstrate a benefit”.And the trial sponsor “only profits if the product is found to be beneficial – in which case so do patients”, he pointed out. As research funders cannot cover the cost of studies alone, “the commercial company takes the financial hit in developing the new product and testing its worth in collaboration with the NHS”.
Weissberg did recognise, though, that more needs to be done to re-assure the public and potential clinical-trial subjects about industry’s motives.
“I think there is concern that commercially sponsored trials may not be as ‘unbiased’ as non-commercial studies because the sponsoring company has a vested interest in a good outcome,” he commented.
That could be addressed through better awareness of “just how such trials are run these days – nearly always by an NHS-based team of clinicians who submit data to an independent (of the commercial company) steering committee that oversees progress and analysis of data”.
Moreover, industry “has let itself down by not reacting appropriately in the post-research phase when a drug starts to run into trouble after it has been adopted in routine clinical practice”, Weissberg suggested.