Scientists warn that delays in the UK’s medicine regulator could mean that an important trial to find ways to treat Long Covid may run out of funding before it is completed.
Researchers searching for treatment options that would benefit millions of long-covid sufferers, who do not have any approved medications, waited for up to six months before the Medicines and Healthcare Products Regulatory Agency could approve the adaptations. The agency is required to make a decision within 35 days.
The Stimulate ICP study was modeled after the UK’s Recovery trial, which found drugs that could be used against acute Covid-19. The study has only recruited 900 out of 4,200 participants it was aiming to recruit. Its funding from UK’s National Institute for Health and Care Research expires in March.
The Long Covid study is stuck in the backlog of the agency. Significant staff cuts have been made since Brexit.
Amitava Banerjee is a professor from University College London, who is leading the study. She said that it was “really disappointing” because although the study had been funded, the MHRA was not able to respond to requests promptly.
“I’m now struggling to figure out how we’ll get this done.” He said that the worst case scenario was that we would have an unfinished job. “If we are unable to provide answers, it is tragic for the patients who do not get any and for the taxpayers whose money was wasted.” The UK government promotes the NHS as an ideal location for clinical trials. The pharmaceutical industry warns that the UK is falling behind other nations due to delays at the regulator and an overloaded healthcare system .
In this year’s Budget, the chancellor allocated to the MHRA a further £10mn to speed up the approval of “cutting edge treatments”.
The agency stated that “urgent actions” were taken over the summer, and most of the delayed clinical trial applications have now been processed. The agency added that, starting September 1, all applications will be evaluated within the legal timelines.
Scientists worry that the NIHR won’t have any money left to fund research on Long Covid after March. Daniel Altmann is a professor at Imperial College London who is studying the biology of Long Covid for a separate study. He said that it was “pretty odd” because medical research is slow and rarely completed in just two years.
He asked, “Why would you make an initial investment if it is not followed through with?”
The NIHR stated that it had invested over £50mn into Long Covid projects, and that timelines for the project could be extended if both researchers and funders agree. The NIHR said that it had invested more than £50mn in Long Covid research projects and that project timelines could be extended if researchers and funders agreed.
According to Office for National Statistics data released in march, 1.9mn individuals, or about 2.9% of the UK population, have self-reported Long Covid symptomatology.
Emma Wall, a consultant in infectious diseases who is leading the Stimulate ICP trial along with Professor Banerjee warned that many patients are turning to unproven, and often expensive, treatments without solid research.
“There is a snake-oil economy.” “People are making money off these desperate patients, because there’s a vacuum of good research,” said she.
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