UK’s Long Covid research under threat from regulator backlog, warn scientists
Scientists are warning that delays at the UK’s medicines regulator mean an important trial looking for ways of treating Long Covid risks running out of money before it finishes.
Researchers hunting for treatments that could benefit the millions of Long Covid patients, who currently have no approved drugs, have waited up to six months for the Medicines and Healthcare Products Regulatory Agency to approve adaptations that it is required to rule on within 35 days.
The Stimulate-ICP study is modelled on the UK’s flagship Recovery trial that found drugs to use against acute Covid-19. It has only enrolled 900 of the 4,200 participants that it aimed to recruit, and its funding from the UK’s National Institute for Health and Care Research runs out in March.
But whereas the regulator moved quickly to enable trials during the pandemic, the Long Covid study has been stuck in a backlog at the agency, which has suffered significant staff cuts since Brexit.
Amitava Banerjee, a professor at University College London who is co-leading the study, said it was “really frustrating” because the study was funded but had stalled because the MHRA did not have enough capacity to respond promptly to requests.
“We’re now in a situation where I’m struggling to see how we can get this over the line. And the worst-case scenario is that we have a job that’s unfinished,” he said. “If we’re unable to answer questions, that’s tragic for patients who don’t get answers and for taxpayers who had their money wasted.”
Professor Amitava Banerjee: ‘We’re now in a situation where I’m struggling to see how we can get this over the line’ © UCLThe UK government is promoting the NHS as the ideal location for clinical research. But the pharmaceutical industry has been warning that it is falling behind other countries because of delays at the regulator and an overwhelmed healthcare system.
The chancellor gave the MHRA an extra £10mn in this year’s Budget to help speed up the approval process for “cutting-edge treatments”.
The agency said that it had taken “urgent action” over the summer and the majority of delayed applications for clinical trial approval had now been processed. It added that from September 1, all new and fully compliant applications would be assessed within the statutory timelines.
Scientists are also concerned that after March, the NIHR will have no more money set aside to research Long Covid. Daniel Altmann, a professor of immunology at Imperial College London, who is examining the biology of Long Covid in a separate study, said it was “pretty strange” because medical research takes time and is rarely finished within just two years.
“Why on earth would you want to make the initial investment if you don’t follow through and deliver on it?” he asked.
The NIHR said it had invested more than £50mn in Long Covid research projects and that project timelines could be extended if researchers and funders agreed. It added that scientists could submit proposals for further research through regular funding routes.
Some 1.9mn people, about 2.9 per cent of the UK’s population, are living with self-reported Long Covid symptoms, according to data released in March by the Office for National Statistics.
Emma Wall, an infectious disease consultant who leads the Stimulate-ICP trial with Professor Banerjee, warned that without robust research, many patients were turning to unproven and often expensive treatments.
“There’s a snake oil economy. People are making money out of these desperate patients because there is this vacuum of good research,” she said.
This story originally appeared on: Financial Times - Author:Hannah Kuchler
