The trial was a huge success for the NHS, and the Government has now launched an investigation into whether the trial was properly conducted.
The trial was originally supposed to run from December 2013 to March 2015, but the Department of Health and Care Excellence (DHCE) said it had to postpone it because of the coronavirus pandemic.
On Friday, the Department for Health announced it would be investigating whether the trials was “comprehensive, accurate and transparent”.
Its decision came after a “significant number of allegations” of misconduct by researchers and clinicians.
“It is clear that this was a flawed and poorly conducted trial that failed to deliver the outcomes it claimed to deliver,” said Dr Andrew Jones, chief executive of the Royal College of Surgeons, in a statement.
“We will be taking a number of actions to ensure this trial is properly scrutinised, and it will be fully transparent to the public.”
Axon, which is owned by the pharmaceutical company AstraZeneca, is run by Professor Alan Woodward.
He was originally one of the trial’s co-investigators.
In January 2016, he resigned after he was recorded saying the trial “isn’t scientific” and “won’t get to the bottom of what’s going on”.
In October 2016, the trial halted and was replaced by a different trial led by Professor Woodward.
The trial is now expected to be finished in late December.
Professor Woodward, who was also a co-author on the Lancet study, said he had been “overwhelmed by the response” to the trial and “felt a duty to the people of the UK to report back to the Government and say that I can do more”.
“I think the response has been very good,” he said.
It was “not just the NHS and the public that I’ve been working with, it’s all these organisations across the country”, Professor Woodward added.
However, Professor Alan Woodward’s resignation from the trial has sparked criticism from academics, including Sophie Smith, professor of epidemiology at the University of Oxford.
Smith told the BBC: “It’s incredibly important that people have a good understanding of what the trial is about and how they might benefit from it.”
However Professor Woodward has dismissed the criticism, saying the Lancet report was based on the data and analysis from the trials co-authors.
And the trial appears to have been flawed.
A group of researchers led by Prof Woodward found that patients who received AstraZeno treatment showed significant improvement in their cholesterol and triglyceride levels, but their overall risk of developing heart disease, stroke and kidney disease did not improve.
This was despite Astra Zeno treatment being “very strongly associated with improvements in all three” of these outcomes, the researchers said.
The group’s findings were published in the journal Lancet on Friday.
AstraZeno has been a popular treatment for people with high cholesterol, particularly in high-risk groups such as patients with type 2 diabetes and the elderly.
Dr Woodward has said the study was “very robust” and was “an absolute travesty of the scientific process”.
“We don’t know how many people would have benefited by Astrazeno and the outcomes in the Lancet were not very good, but I think the results of the study, given the way the data was analysed and the results in the paper, are very strong,” he told the Sunday Times.
Other researchers, including Prof Woodward and Dr Pauline Ager, also wrote an opinion piece for the Guardian in November 2016, calling the Lancet paper “silly”.
The researchers who wrote the Lancet piece also told the paper they were not aware of any evidence that Astra Zeno had a “direct effect” on the health of patients with high-cholesterol.
However the authors said the findings were “in line with other studies that have found that the use of a new therapeutic agent can improve the outcomes of older patients with cardiovascular disease, and reduce the risk of mortality in older patients”.