THE former chief executive of the Medicines Healthcare products Regulatory Agency, (MHRA) Dr Ian Hudson OBE has been struck off by the General Medical Council. The decision was published yesterday.
The disgraced former paediatrician was convicted on July 30, 2024, at Chelmsford Magistrates’ Court of two counts of attempted sexual communication with a child, more commonly referred to as grooming. He had been charged by Essex police after being caught in a police sting during the summer of 2023. In online chats of a sexual nature with undercover police officers who had told him they were females aged 13 years old and 12 years old respectively, Hudson asked both girls for photos and asked them sexual questions. He told the tribunal he was on the chat site ‘as a distraction from stresses and anxieties that he was not coping well with’.
Hudson retired from the MHRA in September 2019. He gave up his license to practice in 2019 but remained on the GMC register. While he was working for the MHRA, his GMC professional registration fees were expensed.
The GMC requires anyone on its register to notify them of any criminal charges or convictions. In Hudson’s case, they didn’t become aware of either until 30 September 2024, when he disclosed them on a Voluntary Erasure form when he tried to deregister himself entirely before his sentencing hearing on October 28, 2024.
Hudson’s 2024 conviction escaped press attention at the time. He pled guilty at his trial and was later given a six month suspended prison sentence, ordered to sign the Sex Offender Register for ten years and was subject to a five-year sexual harm prevention order.
All the usual conditions – criminal conviction, professional misconduct and major reputational damage – now exist for the Honours Forfeiture Committee to reconsider his OBE; a forfeiture review may also occur.
Representing himself at the Medical Practitioners Tribunal hearing, Hudson argued that ‘elements of his work that required him to be on the medical register despite having no contact with patients’ and given his significant expertise and experience ‘he still had a lot to offer for the benefit of wider society and could do so without risking the public’. He had, he said, ‘good insight into his actions and had done as much to remediate as he could think of’.
With the tribunal having found his offences to be at the upper end of seriousness and that there was a risk of repetition, counsel for the GMC argued for his immediate suspension and said erasure from the GMC Register was in the public interest. She said there were no extenuating circumstances for the tribunal to take into account.
In 2014, shortly after Hudson left his role as the MHRA’s director of licensing to become its chief executive, he told Civil Service World Magazine: ‘Through research, I’ve been involved in the development of [medical] products that will affect the lives of many more millions of people than I would have if I’d had a life in clinical practice.’
His record and his impact on the lives of millions invites further scrutiny, particularly as during the pandemic, Hudson worked for BMGF as its senior adviser of Regulatory Affairs, Integrated Development and Global Health.
Others working in the Global Health division at that time included Dan Wattendorf, the former DARPA officer who established the rapid-response genetic vaccine programme which Moderna was set up to commercialise, and Raj Long, BMGF’s then deputy director of Pharmacovigilance and Gene Drive regulation, who supported the World Health Organization’s Covid-19 manufacturing taskforce and now sits on the MHRA Board of Directors.
Ostensibly his role was in strengthening medicines regulation and pharmacovigilance in low- and middle-income countries. However in 2021 it was reported that Hudson was providing advice to teams working on Covid-19 vaccines.
The breadth of his professional experience would certainly make Hudson a uniquely valuable resource to the regulatory arbitrage scheme crafted to get DARPA’s mRNA P3 Pandemic Prevention Platform, to which mRNA vaccines were central, past medicines regulators.
Hudson initially left his career as a paediatrician to work in drug development for SmithKline Beecham, the predecessor to GlaxoSmithKline.
He first came to public attention as the company’s director and vice-president of Worldwide Clinical Safety after testifying on behalf of the company in a US court case over its controversial anti-depressant Paxil (paroxetine). The lawsuit alleged the company failed to warn doctors and patients that the drug was causing an increase in suicidal thoughts and behaviours in adolescent users. Further lawsuits were brought amid allegations that the company was marketing it for adolescent use despite the safety concerns and a lack of evidence for its efficacy. In 2005, the FDA issued a black-box safety warning for Paxil based on regulatory safety findings and doesn’t permit Paxil’s use in adolescent and paediatric populations.
Pivoting to a regulatory role, Hudson joined the MHRA’s predecessor the Medicines Control Agency (MCA) in 2001 as Director of Licensing. Consumer groups fearful of overly close relations between industry and the regulator were openly critical of the appointment as was the late Paul Flynn MP who did so much to expose the 2009 Swine Flu fraud.
Flynn joined the consumer groups, criticising the culture of secrecy at the regulator which he considered ‘defensive, pro-industry and anti-consumer’. While working for the MHRA Hudson became the vice-chair of the European Medicine’s Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), and the chair of the International Coalition of Medical Regulatory Authorities (ICMRA), the organisation leading efforts to harmonise medicines regulations globally. ICMRA provides guidance on clinical trial design and regulation and issued guidance in 2020 to step up global collaboration by medicines regulators on Covid-19 vaccine and therapeutics.
Six months after Hudson and Dr June Raine visited the Gates Foundation at its Seattle Headquarters, Hudson took up the post with it immediately following his retirement from the MHRA in September 2019. Raine, who was the MHRA’s Director of Pharmacovigilance, was appointed as the MHRA’s interim chief executive following Hudson’s departure. She continued acting as CEO under delegated authority until February 2021, becoming its permanent CEO after the Regulation 174 authorisations for temporary supply for the Covid-19 vaccines were issue.
Customarily senior civil servants have to wait two years to take up private-sector roles. The Advisory Committee on Business Appointments set it aside in Hudson’s case in recognition of the foundation’s focus on low- and middle-income countries and its plans to help to strengthen their regulatory systems. ACOBA said Hudson wasn’t permitted to lobby the MHRA directly or use any proprietary knowledge.
Between 2016 and 2019, while Hudson led the MHRA, the BMGF awarded it over £1.6million in grants. The first of these was funding for the National Institute of Biological Control and Standards (NIBSC) to develop reference standards for the measurement of immune responses to Shigella and Group B Streptococcus vaccines.
Due to a regulatory loophole in Europe, BioNTech’s mRNA covid vaccine which was registered in a European clinical trial was not subject to the more onerous advanced medicines clinical trial protocols. Moderna, whose mRNA-Covid vaccine clinical trial was registered in the US, had a theoretically more difficult path to licensing in the US as the FDA clearly classifies mRNA vaccines as gene therapies. The European loophole, exempting gene therapy products targeted at infectious diseases from being evaluated as gene therapies if it was claimed that they were vaccines, was incorporated directly into UK law in a January 2018 Brexit Statutory Instrument. Viewed with benefit of hindsight, it gives the arbitrage scheme a pre-planned appearance.
Both mRNA-vaccines use the same National Institute of Health (NIH) patented design under licence. The successfully executed regulatory arbitrage game in play was first to obtain a conditional marketing authorisation from the European Commission for the Pfizer/BioNTech product on whose coat-tails the Moderna vaccine could ride. The European Commission issued Pfizer-BioNTech with a conditional marketing authorisation on December 21, 2020. Moderna’s followed on January 6, 2021. The special adviser to Commissioner Ursula von der Leyen was Coalition for Epidemic Preparedness Innovations’ (CEPI) then Vice-Chair Dr Piet Piot. Neither the FDA, nor the MHRA who issued the emergency use authorisations for unapproved investigational medicines based on a mere two months of follow up data on clinical trial participants, were legally responsible for the marketing authorisations for DARPA’s mRNA vaccines which survived the end of the World Health Organization declared emergency period.
Hudson’s full-time paid position with the BMGF didn’t preclude him from taking up other advisory positions. In 2021 he became a non-executive director of Sensyne Health, an AI healthcare company set up in 2015 by Lord Drayson, who served Prime Ministers Blair and Brown respectively as a Defence Procurement Minister and as a Science Minister. The company, which was an Oxford University spin-out, was the first to use AI to mine NHS patient records in order to speed up the development of new drugs. In 2021, DHSC awarded Sensyne a pilot contract to use its MagnifEye AI technology to interpret lateral flow test data. Another AI product, Syne-Cov, was licensed by the MHRA and used in hospitals to manage patient care and hospital resources by predicting whether covid-positive patients would develop severe disease requiring ICU support or mechanical ventilation.
Incestuous is the only adjective to describe the furtherance of these government-advantaged business interests. Professor Sir John Bell, a long-standing member of the BMGF’s Scientific Advisory Committee and co-author of the UK government’s 2017 Life Sciences Industrial Strategy, was Sensyne Health’s Chairman until 2018. Lord Drayson, Sensyne’s founder and former CEO, is himself no stranger to the pharmaceutical industry. He made a £43million fortune when he sold his company Powderject Pharmaceuticals to Chiron Corporation in 2003. It was taken over in 2006 by Novartis which in 2015 sold its vaccine arm including the old Powderject factory in Speke outside Liverpool to CSL Seqirus, a key government supplier which manufactures influenza vaccine there to this today.
Until news of his criminal convictions and the tribunal’s decision to strike him off became public, Hudson was advising Apriori Bio on Regulatory Affairs. His name was quickly removed from its website. The company was founded in 2020 by Flagship Pioneering, the Massachusetts-based bio-tech incubator that established Moderna in 2010. Apriori’s executive leadership includes Dr Seth Berkley, a former Rockefeller Foundation trustee who was previously the CEO of GAVI the Vaccine Alliance, and Ashish Jha, who was the White House Covid-19 co-ordinator in 2020. Dr Katrin Jansen, formerly head of Pfizer’s vaccine division, is another of its advisers.
Apriori is developing an AI platform called Octavia which it says will ‘protect humanity against rapidly-evolving viruses by designing variant-resilient vaccines’. In July 2024, it was awarded $1.1million (£820,000) by the BMGF-funded Coalition for Epidemic Preparedness Innovations (CEPI), to develop this AI platform which the company says will identify the mutations with the greatest escape potential. CEPI, whose mission is to develop ‘just in case, just in time’ vaccines in 100 days, has tasked Apriori with working on H3N2 pandemic influenza which affects pigs, birds and humans.
‘By focusing on the range of potential deadly viral variants that could emerge from deadly pathogens ahead of time, we could seriously speed up our response to a future outbreak,’ said In-Kyu Moon, CEPI’s acting director of vaccine development.
In her foreword to the MHRA’s 2019 annual report, its then interim chief executive Dr Raine thanked Dr Hudson ‘for all his work in safeguarding public health’. A more fitting epitaph for Dr Hudson is ‘he was a servant of pharmaceutical industry interests to the end’. Whether his work safeguarded anything other than industry interests is a different question.
