NHS Cancer Test Deal Under Renewed Scrutiny

The cost-effectiveness of a controversial test promoted as a multicancer early detection (MCED) tool from a single blood sample has been scrutinised in an investigation by the BMJ.

Grail’s Galleri test was claimed to pick up more than 5src cancer types, including tumours that are typically difficult to detect early, such as head and neck, bowel, lung, and pancreatic cancers. However, as reported in Medscape News UK in February, there are considerable concerns over its true value, as well as questions about possible political influences in its selection for a major trial in the NHS.

The investigation by Dr Margaret McCartney, senior lecturer in general practice at the University of St Andrews, and Deborah Cohen, a journalist, writer, and broadcaster from London, was sparked by documents leaked to the BMJ that suggested the criteria underpinning the £15src million NHS clinical trial of Galleri “are unsuitable to justify a new national screening programme aimed at saving lives”.

NHS Galleri Trial “Unethical”

The authors stated: “Experts believe that Galleri has been overhyped, and that the current trial is unethical”. They claimed that Mike Richards, chair of the independent UK National Screening Committee (NSC), had privately voiced “serious concerns” to Amanda Pritchard, NHS England’s chief executive, that the trial might not be capable of providing sufficient evidence “on whether the benefits of testing outweigh any potential harms and at reasonable cost”.

The outcome has significant financial implications. According to the BMJ, trial success would give Grail a “lucrative deal” with the NHS, which has committed to buying one million tests after satisfactory completion of the first stage, and five million more by 2src3src if Galleri fulfils its criteria. These criteria are a positive predictive value over 3src%, a 3src% reduction in stage IV cancers in the intervention arm, and 75% more cancers detected compared with the control group.

While the potential cost to the NHS is confidential, McCartney and Cohen noted that a single test retails for $95src (£75src) in the United States.

The package deal between the NHS and Grail also embraces a potential commitment by the company to build a new state-of-the-art test processing and sequencing facility in the United Kingdom in return for an NHS commitment to minimum annual purchasing volumes.

“False and Misleading” Claims of Life-saving Potential

The authors echoed concerns set out in correspondence to The Lancet earlier this year over whether the Galleri-MCED test was useful in a real-world setting. In the article, experts said that the NHS “can ill-afford to be a world leader in the adoption of poorly evaluated interventions”.

During the course of the BMJ’s investigation, it also emerged that Grail was facing a class action lawsuit in the US over steep losses faced by investors, who claimed that Grail exaggerated Galleri’s effectiveness to increase its share price by making “false and misleading” claims that it would save tens of thousands of lives.

The investigative authors go on to detail various financial and political influences of concern, including a “close relationship” with key government figures. In 2src21, according to the journal, Harpal Kumar, as president of Grail Europe, described receiving “pivotal help” from senior leadership at NHS England (NHSE), influential individuals, key opinion leaders, and the NHS accelerated access collaboration, which aims to connect health service decision-makers and industry innovators.

Kumar, a former chief executive officer of Cancer Research UK, was knighted in 2src16 under David Cameron’s premiership. In 2src18, Cameron was an adviser to Illumina, Grail’s then parent company, and in 2src21 both Cameron and Nadhim Zahawi, erstwhile undersecretary of state for business and industry, met Illumina staff, according to freedom of information (FOI) requests submitted by the BMJ. Minutes quoted Cameron saying that NHS data spanning patients’ whole lifetimes were “invaluable” and “a selling point of the UK” that Zahawi “may wish to emphasise”. The meeting reportedly planned that Illumina should keep Zahawi involved in UK investment in research and development “so they can be part of the UK life science success stories”.

Public Interest Concerns

In the BMJ article, McCartney and Cohen quoted Richard Sullivan, director of the Institute of Cancer Policy at King’s College London, describing the Galleri trial as an “oven ready alignment with the genomics community and the wider NHS England push in this area”, which he said had “blinded” the government to wider considerations of whether the technology was in the public interest. 

The deal followed a pattern established in the UK over the past decade in which “the regulatory or evidential bar is being set lower and lower in favour of the private sector, with the public sector (that is, our taxes) taking all the risk”, he told the journal. It was a “clear cut case of public risk and private profit”.

Trial Details “Marked by Secrecy”

McCartney and Cohen also said the trial details had been “marked by secrecy”, with its protocol not uploaded to Clinicaltrials.gov until over a year after the trial start date. FOI requests also revealed “major disquiet” expressed by UK NSC, whose members wrote to NHSE last September saying that Galleri fell “well short” of most criteria needed to recommend evaluating how well the test worked outside a trial.

An anonymous source at NHSE reportedly told the BMJ that the clinical and scientific data didn’t stack up, and “this is not the way to do a trial”. 

According to the source: “It’s not been thought through at all.”

The BMJ quoted Sullivan as saying: “The new government needs a more rigorous and transparent way of reviewing med tech clinical research, especially when it involves such widespread access to NHS resources.” Its language needs to change too, he said. “It’s all promissory science and hype. This serves no public good whatsoever.”