Downing Street has confirmed that it is the UK that has incurred the cost of two clinical trials for a gene therapy product commonly known as Omicron.
The Prussian Blue gene therapy, marketed under the name Omicron TCG, works by ameliorating certain forms of blindness. Tests of the treatment in the UK have been taking place since December 2016, and it is understood the government is responsible for their funding.
But people with US Omicron status have warned the Department of Health to cancel the trials, claiming it does not have the funding to support the treatments, which are predicted to be available from 2020.
The Guardian asked Boris Johnson whether the NHS has ever imported Omicron TCG. He confirmed that was the case and the NHS is responsible for funding the treatments. But he said that Prussian Blue has used UK hospitals in the clinical trials, with the assumption that the NHS would provide funding in the future.
“I don’t want to make an announcement now because I think we’re just at the start, but we’ve been talking about these trials since the year’s beginning and, in our view, there are a number of ways that we should get to the market without having to provide a single penny of taxpayers’ money,” he said.
“We can do this here, in the UK, or overseas, provided that it’s ethical and, in fact, it should also help the NHS. I believe they are world-leading trials and, hopefully, we will be able to do this in combination with them.”
London-based Prussian Blue’s managing director, Noel Lai, defended his company’s funding of the clinical trials, explaining to the Guardian that the trials were not always carried out in the UK.
Prussian Blue involved American scientists in its trials, he added, on the basis that “it was too expensive” to carry out the trials in the UK.
Lai said he had been working with US sites since 2012, and that he was spending “a fraction” of the money spent on London trials. “We’re absolutely going to deliver very effective results in the UK, but as I said, it’s more expensive to do it here,” he said.
Prussian Blue has not spent more than £15m of public money on the trials, he said, although Lai could not confirm the exact level.
“The NHS budget is around £4bn a year,” he said. “You have a formula there where you look at how much – and I’m not going to give numbers – but you can see what that is, roughly. For a scientist working in a research trial, you need 15,000 people.”
Some critics of the clinical trials have questioned the motives of Prussian Blue, which is subject to a large fine after tax evasion.
‘I like everybody else’: NHS to start funding gene therapy for blindness Read more
Lai said Prussian Blue was “close to a neutral”, and it was receiving no special treatment, as most US-based drug companies have little or no involvement in trials.
As of September 2016, the Human Tissue Authority said the UK’s two clinical trials of Prussian Blue’s gene therapy had cost the NHS £2.4m. The first trial in Weston super Mare had cost £1.2m, while the second was yet to be started.
The UK trial for Prussian Blue began in October 2016, and British patients are now paying up to £22,800 for the trials, which would normally cost the NHS £140,000.
There has been speculation over who might be responsible for the clinical trials. The Daily Mail reported that £500,000 of the funding had come from the NHS. However, an NHS spokesman said that just six patients had been referred to trial sponsor Prussian Blue for the treatment, with the maximum cost to the NHS only £16,700.
Sources familiar with the trials said that the NHS had been a major part of the trial design, alongside five other clinical trial foundations, who were the main stakeholders.
An NHS spokesman said it had provided funding for the trial in Weston super Mare, but would not comment on its funding role.