ENGLAND: Covid Vaccines MHRA drug scandal

Failing vaccines, perhaps? Time to hold those in charge's lives forfeit. A punishment best served, as a warning to others, of the no go point, in any future vaccines drive.

Covid Vaccines MHRA drug scandal

By

Paula Jardine

July 15, 2024

WHEN Dame June Raine, chief executive of the UK Medicines and Healthcare products Regulatory Agency (MHRA), said her organisation was shifting from being a watchdog to being an enabler, gosh golly but she meant it. Since 2020 MHRA has developed a habit of providing assistance to well-connected US drug developers with friends in high places – like Dr Robert Kadlec, the mastermind behind the US bio-defense project responsible for the Covid-19 debacle. This assistance has taken a particular form – the issuing of questionable but critical pharmaceutical authorisations.

On November 4 2021, following another of its ‘rigorous’ reviews, the MHRA became the first regulator in the world to authorise the oral antiviral molnupiravir, a drug in development for treating Covid-19 and which MHRA declared ‘safe and effective’ after it was tested on all of 775 people.

This was a conditional marketing authorisation for the new anti-viral, marketed in Great Britain by MSD (Merck) under the brand name Lagevrio. In Northern Ireland, where European Union law remains in effect, the MHRA issued a Regulation 174 authorisation for temporary supply, as otherwise a conditional marketing authorisation would have needed to be issued by the European Medicines Agency under its central authorisation procedure.

The authorisation states molnupiravir is indicated to ‘treat mild to moderate Covid-19 (caused by SARS-CoV-2) in adults who are at risk for developing severe illness’. It can be prescribed following a positive diagnostic test for SARS-CoV-2 to vulnerable non-hospitalised patients with at least one co-morbidity such as diabetes, which increases their risk for severe disease. They are to take a pill twice a day for five days and to do so within the first five days of (covid) illness, ‘to stay out of the hospital and feel better’, or so it is promised.

Dame June Raine has repeatedly assured us that ‘With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.’ But can we? As with MHRA’s authorisation of the earlier covid vaccines, BioNTech’s Comirnity, Moderna’s Spikevax and Oxford-AstraZeneca’s Vaxzevria, the answer is we cannot.

Once again, this particular authorisation came swiftly on the heels of the interim analysis of a phase 3 clinical trial which was only fully enrolled on September 21, 2021 and before any medium- or long- term adverse effects could be properly evaluated.

In the final analysis 775 unvaccinated, non-hospitalised subjects with at least one risk factor for severe covid were given molnupiravir which was evaluated against an unidentified placebo given to a similar number of subjects.

One molnupiravir recipient and nine placebo recipients died in the month after they were dosed. Evidently the placebo was not saline as 33 per cent of placebo recipients suffered an adverse event, which was slightly more than the 30.4 per cent of molnupiravir recipients who suffered an adverse event. What exactly was this comparator substance against which molnupiravir appeared safe? We do not know as it’s never been disclosed.

At the time of the MHRA authorisation, the Department of Health and Social Security purchased 480,000 courses of molnupiravir from MSD (Merck) on the recommendation of an antivirals therapeutics task force set up in April 2021 and chaired by Eddie Gray, a former GSK executive and board member of the Association of British Pharmaceutical Industry. The job of this task force, the then Chief Scientific Officer Sir Patrick Vallance said, was to ‘ensure the most promising antivirals would be available for deployment as quickly as possible’. The task force’s members included who else but Dr Dame June herself, Professor Sir Jonathan Van-Tam, the Deputy Chief Medical Officer, and the ubiquitous Sir Jeremy Farrar, who was at that time Executive Director of the Wellcome Trust.

They were working not on their own but with another ‘multi-agency initiative’, Research to Access Pathway for Investigational Drugs for COVID-19 (RAPID C-19). This was an oversight group chaired by the National Institute for Health and Care Excellence (Nice) programme director for commercial and managed access, which was set up early in 2020 to help out pharmaceutical companies by pushing their products into use by the NHS as soon ‘as there is strong evidence which shows the treatment is effective’.

To nudge this along, the UK government helpfully provided extra guinea pigs to enable molnupiravir testing on a larger scale than its phase 3 trial by offering it to the public via the Oxford University-run PANORAMIC clinical trial. Was it in order to encourage those extra volunteers that the conditional authorisation was so critical? Volunteers are surely more willing to try a novel drug with a conditional marketing authorisation than they are to take part in a clinical trial of the same medicine whilst it is unlicensed? In this context the unwarranted reassurance given by the MHRA about the safety and efficacy becomes even more deceptive and ethically questionable.

The Panoramic trial began recruiting volunteers on December 8, 2021, the first anniversary of the covid vaccine roll-out. With only 4,000 of the target 20,000 volunteers recruited by the start of January, the government urged the public to sign up for ‘a world first’ covid antiviral study.

Pippa Erskine, a cystic fibrosis sufferer who had received a double lung transplant, explained why she volunteered: ‘Even after three vaccines, testing positive for COVID-19 after avoiding the virus for more than 18 months was worrying. Knowing antivirals would help ease my symptoms and help prevent potential complications was a huge relief.’

The Department of Health drive was very successful, recruiting 29,295 volunteers to the Panoramic trial, which was also testing another antiviral, Paxlovid, for Pfizer.

The results of the trial were not good. In May 2023 Nice issued a draft negative recommendation for molnupiravir, against which MSD (Merck) appealed. As of April 2024, Nice is still appraising molnupiravir’s clinical and cost effectiveness for use by the NHS and expects not to publish its final opinion until January next year.

Evidence suggests it is one of the least effective and most expensive of all the therapeutics purporting to treat Covid-19. A May 2023 meta-analysis of molnupiravir clinical studies by the University of Cologne showed the drug had no efficacy. In January 2024, the Panoramic trial acknowledged that at £513 per course it may not be a cost-effective treatment for the NHS but ‘may be beneficial for patients over the age of 75’.

The MHRA authorisation remains in place. In the competitive market for drug regulators, it appears that lack of efficacy is an insufficient reason for MHRA to pull an authorisation. After all, it would harm the commercial interest of a company.

MOLNUPIRAVIR has a controversial history. It featured heavily in the whistleblower complaint filed in April 2020 by Dr Rick Bright, the former Director of the US Biomedical Advanced Research and Development Authority (BARDA) after he was fired by a certain Dr Robert Kadlec, the Assistant Secretary of Preparedness and Response (ASPR) at the Department of Health & Human Services (HHS) in the Trump administration. Kadlec is the man behind the Manhattan Project for Biodefense which, in turn, propelled the US Defense Advanced Research Projects Agency’s (DARPA) insane Pandemic Prevention Platform project forward at Warp Speed, pushing mRNA genetic vaccines into billions of arms. He has also, for the last 20 years, been a shameless lobbyist for the vaccine industry.

Molnupiravir, which is named after the old Norse Mjölnir meaning ‘Thor’s hammer’, was originally called EIDD-2801. It was developed by a company called Drug Innovations at Emory (DRIVE) LLC, a non-profit spin-off from Emory University in Atlanta, Georgia, using $35million in funding from the US National Institutes of Health (NIH) and the US Defense Threat Reduction Agency (DTRA). Development started in 2013 yet by 2019 it had not entered a clinical trial.

Dr George Painter, Molnupiravir’s inventor who is the director of the Emory Institute for Drug Development (EIDD) and CEO of DRIVE, is a friend of Dr Robert Kadlec. They have been acquainted for at least 20 years, since the days when Dr Painter was trying to develop an antiviral against the putative threat of smallpox which he hoped the US government would purchase and stockpile under Project Bioshield which Dr Kadlec launched in 2004.

On November 1 2019 Dr Kadlec summoned BARDA’s two top officials, Dr Bright and his deputy Dr Gary Disbrow, to a meeting with Dr Painter. Painter, Dr Bright said, presented EIDD-2801 as a ‘cure-all for influenza, Ebola and every other virus’. Bright also revealed in his April 2020 whistleblower complaint that he was pressured by Dr Kadlec to award millions more in BARDA funding to DRIVE as Dr Painter wished to begin manufacturing EIDD-2801 immediately. Dr Bright refused to do this without a prior clinical trial because he ‘knew that similar experimental drugs in this class had been shown to cause reproductive toxicity in animals, and offspring from treated animals had been born without teeth and without parts of their skulls’.

Dr Bright’s refusal to fund the drug without further study drew the ire of Dr Kadlec. Following the meeting, Dr Bright says he and Disbrow were repeatedly asked in staff meetings and phone calls if BARDA was going to fund EIDD-2801. Bright says that in late 2019, Kadlec called a second meeting between them and Emory University to try to get them to change their minds. Bright remained resolute, as his investigations revealed that DRIVE had already received enough funding to advance EIDD-2801 to a phase 1 trial.

On March 28, 2020 DRIVE licensed EIDD-2801 to Ridgeback Therapeutics, a company which in 2018 licensed EBANGA, an Ebola monoclonal antibody (mAB114) developed by the NIH for DARPA and tested during the Ebola public health emergency of international concern (PHEIC) declared by the World Health Organization in 2019.

Dr Painter said: ‘With EIDD-2801 close to entering clinical trials for influenza and its activity against the SARS and MERS coronaviruses, we immediately recognised that EIDD-2801 had the potential for treating Covid-19. Based on our extensive testing, we believe EIDD-2801 will be effective in treating individuals that have been sickened by Covid-19 . . . Given Ridgeback Biotherapeutics’ experience in accelerating the development of potential therapeutics in outbreak settings and its proven commitment to global health, we are confident that Ridgeback can quickly advance EIDD-2801 into clinical trials for Covid-19 and initiate steps toward ensuring a rapid development path for this promising drug.’

Within a week, circumventing proper channels, Ridgeback and Painter returned to HHSseeking $100million in funding for a clinical trial of EIDD-2801 that they planned to start the next day (April 8, 2020).

Bright says: ‘Dr Painter and Mr [Joel] Clerici, [a pharmaceutical lobbyist with a long association with Dr Kadlec] contacted ASPR Strategic Innovation and Emerging Technology Manager Joe Hamel, a personal friend of Dr Kadlec and the head of ASPR Next, an opaque funding program within ASPR that was established in August 2019 to fund products, equipment, and technology to assist with health care emergencies.’

ASPR Next had no staff with the technical expertise to evaluate drug safety. Painter was not granted funding by BARDA or ASPR Next before Dr Bright was fired on April 20, a few weeks before Operation Warp Speed was launched on May 15, 2020.

Having failed to obtain funding for EIDD-2801 from either BARDA or ASPR Next, Ridgeback appear to have decided to underwrite the development for DRIVE themselves. On May 26, despite no further funding from Health and Human Services (the department that housed BARDA and ASPR Next), Ridgeback entered into a collaboration agreement with Merck who agreed to manufacture and market molnupiravir (EIDD-2801) for them. The two companies avoided mentioning the previous US government funding.

Even though Rick Bright had been fired, Operation Warp Speed did not fund EIDD-2801 either. But Dr Kadlec didn’t fail entirely to assist his friend.

As a backup in case EIDD-2801 didn’t work during clinical trials, Emory University responded to an April 14, 2020 request for proposals from the Medical Countermeasures Development Consortium (MDCD) putting forward another candidate drug, EIDD-2749. On July 1, 2020, they were awarded $11,192,009 in funding via Operation Warp Speed to develop ‘EIDD-2749 and supplemental candidates against Alphavirus, Arenavirus and Other [redacted] Biodefense Threats’, which appears to have been Respiratory Syncytial Virus (RSV).

During 2021 Merck (MSD) manufactured 10million courses of the drug for Ridgeback and DRIVE at its own commercial risk. Merck said it was ‘committed to providing timely access to molnupiravir globally’ and intended to ‘implement a tiered pricing approach based on World Bank data that recognises countries’ relative ability to finance their public health response to the pandemic’. Presumably this meant if it sold enough to rich countries like the UK at its £513 per course sticker price, it would discount it for less well-off countries.

In June 2021, the US Department of Defense agreed topurchase 1.7million courses from Merck at a cost of $1.2billion. However Merck could deliver the product and get paid only if it was first able to obtain an Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA). This is a necessity rather than a nicety. The substance, a biological agent with an inherent risk of causing harm or death, had been developed with funding from the US Department of Defense’s Defense Threat Reduction Agency, was manufactured in large quantities prior to authorisation, which means it technically had the potential to be a breach of the Biological Weapons Convention 1972. The US government needed to take delivery of an authorised medicinal product, not a biological agent.

The MHRA once again appears to have been recruited, perhaps by Dr Kadlec’s friend Dr Richard Hatchett who was acting as an expert adviser to the UK government’s Vaccine Taskforce, to assist with an authorisation, as they were with BioNTech’s BNT162b2. The MHRA issued a Conditional Marketing Authorisation (CMA) on November 4, 2021 and a Regulation 174 Authorisation for Temporary Supply in Northern Ireland. The prior authorisation by the MHRA appears to have facilitated an FDA EUA.

Merck submitted a request for an emergency use authorisation to the US’s FDA on October 11, 2021. However the FDA didn’t issue one until December 23, 2021, seven weeks after the MHRA had issued the CMA. What might have caused the delay? Some members of the FDA’s equivalent of the UK Commission on Human Medicines reviewing Merck’s application may have shared Dr Bright’s concerns about the drug’s potential to cause birth defects. They did not unanimously support the authorisation. It was narrowly approved by a 13 to 10 vote. Were some of the ‘yes’ voters swayed by the prior authorisation by MHRA?

The European Medicines Agency (EMA) regulator was not so easily persuaded. On November 23, 2021, following the MHRA authorisation, MSD (Merck) also submitted an application for a conditional authorisation to the EMA, suggesting in an accompanying press release there was demand for molnupiravir on the basis that a member state had already issued an authorisation for temporary supply ‘which is intended to support national decision-making on the possible use of molnupiravir prior to marketing authorisation’.

That ‘member state’ was the not-quite-member-state of Northern Ireland. The EMA resisted this pressure, declining ever to issue one. Merck withdrew its EMA application on June 27, 2023.

There is one remaining oddity in the tale of the ‘Thor’s hammer’ drug. On December 22, 2021 the UK government, having initially acquired 480,000 courses, announced it was buying an additional 1.75million courses of molnupiravir from Merck Sharp and Dohme (MSD) to ‘help fight omicron’.

It is not clear why the UK needed to acquire so much molnupiravir in December 2021. The PANORAMIC trial (described in Part 1) was barely under way and hadn’t started its evaluation. Furthermore, the 480,000 courses already acquired were way more than sufficient given that PANORAMIC’s target was to recruit 20,000 volunteers.

One possible explanation is that amid the irrational exuberance of pandemic spending, the UK government was giving a helping hand to a multinational corporation in need by taking some molnupiravir off Merck’s hands. In doing so it was keeping an investor in the UK Vaccine Manufacturing and Innovation Centre (UKVMIC) onside. Merck had a seat on the UKVMIC Board alongside Dr Hatchett whose appointment on January 1, 2020 coincided with the Chinese announcement about Wuhan pneumonia cases that kicked off the pandemic.

In any event, the financial arrangements remain opaque. The UK government contract finder shows a contract value of $1 and, citing commercial sensitivity, the Department of Health (DHSC) has never disclosed how much it actually paid for molnupiravir. The contract was awarded without prior publication of a call for competition due to what DHSC said was ‘extreme urgency brought about by events unforeseeable for the contracting authority’ without elaborating on exactly what these might be. Failing vaccines, perhaps?

TCW