From FDA to MHRA: are drug regulators for hire?
BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o1538 (Published 29 June 2022) Cite this as: BMJ 2022;377:o1538
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Dear Editor, Searching and informative investigative piece. Drug discovery is a complex, laborious and exhaustive process wherein of the several compounds tested, only one may reach the chance of being put to therapeutic use. Further the submissions to authority required have to voluminous with ample justifications and compliances. With such a machinery, it is most desirable that the operation is public funded and economic independence assured. There is always scope for need based subject experts opinions that can be availed on a periodic and rotational basis. Expediency will always be sought as 'critical timelines ' matter in industry calculations, and compliance to 'phasic norms'. COVID pandemic necessitated 'compressed timelines' and Emergency Use Authorisation (s) on need based basis. Organised Structures, inherently strong can withstand pressures that are inherent ; particularly relevant with drug industry, where products are 'global'. Business friendly countries that are open and promote research and innovation too are subject to standard practices that are a must in matters of human health. As the report points to 'happenings ' , the factor of human infirmity and vulnerability tends to exist. Overall modifications in SOPs and course corrections can help improve the situation where deficiency has been identified. Murar E Yeolekar, Mumbai.
Competing interests: No competing interests
Dear Editor,
Recently there was a paper which looked at trials conducted between years 1987 to 2021 which concluded that evidence for benefits from statins was weak at the best and many of the trials were funded by pharmaceutical companies.
There is a new statement from FDA is evidence for benefits from routine multivitamin supplement is weak and use of high dose vitamin A and E may be harmful. There is revised opinion about use of Aspirin for Primary Prevention.
During CoVID-19 Epidemic many drugs were touted as magic bullets which did not pass the test of time.
To add to the confusion there are many over the counter drugs available often even content of which is not known.
Forget the lay people even doctors have no way to know the truth.
Competing interests: No competing interests
Re: From FDA to MHRA: are drug regulators for hire?
Dear Editor,
We read with interest Maryanne Demasi’s BMJ Investigation of 2 July (‘Led astray? Industry’s influence on drug and device watchdogs’). We fully agree with the introductory statement that medicines regulators must provide ‘an unbiased, rigorous assessment of investigational medicines before they hit the market’.
Regulators must strike a difficult balance to protect patient safety whilst fostering innovation. The meaning of the word ‘rigorous’ is critical. Patients rightly expect medicines to have been subject to scrutiny that is rigorous, in the sense of being scientifically rational, detailed and expert. However, regulation that is scientifically inexpert and dogmatic causes harm to patients – including deaths and severe illness – by delaying the availability of drugs that may help them.
As doctors specialising in pharmaceutical medicine and with a variety of roles in drug development in academia, industry and the NHS, we have each worked with medicines regulators in the UK and around the world. We wish to reassure BMJ readers that the UK’s medicines regulator, the MHRA, does a difficult job outstandingly well and with ‘eyes wide open’ to potential conflicts. The UK medicines regulatory system is highly respected internationally, as evidenced by the substantial contributions it makes to international regulatory collaborations[1]: for example, prior to Brexit, MHRA co-ordinated the responses to over 20% of requests to the European Medicines Agency for scientific advice[2].
Regulatory systems should be subject to continuous improvement, guided by current scientific opinion. We fully agree with the article’s suggestion that adequate public funding of regulators – rather than excessive reliance on fees paid by drug developers – is desirable. Such funding complements other safeguards of independence and allows the investment of time and effort in increasing regulatory strength and efficiency for the future. It is critical, however, that efforts to strengthen scientific rigour do not inadvertently have the opposite effect. Unthinking bias against those with industry links contributing to the regulatory process is not in patients’ interests.
Drug development is a complex and varied process: while the MHRA is a public agency, it needs external advice to support its decision-making. We live in a world in which private industry is involved in the development of almost every medicine. The vast majority of scientists and doctors who have first-hand expertise in drug development thus interact with industry, often alongside academic or clinical roles, in one way or another. A regulatory system cut off from first-hand expertise cannot make good decisions.
The MHRA’s advisory body, the Commission on Human Medicines (CHM), has a robust Code of Practice including declaration of interests and recusal from discussions in which an individual has an interest [3]. It recently consulted on further strengthening this policy [4]. The fact that many CHM members declare interests is, in our view, consistent with obtaining advice from a broad cross-section of those with relevant expertise, coupled to an effective culture of transparency: it should be seen as a sign of success.
The focus of the article upon advice relating to COVID-19 vaccines in fact highlights an outstanding success of the MHRA, in having allowed the deployment of safe and effective vaccines in the UK faster than anywhere else in the world. The UK regulator took the right decisions, by having a process which is rationally rigorous rather than irrationally arduous. It did that through scientific expertise, including obtaining a broad spectrum of expert advice.
Yours sincerely,
Flic Gabbay, Allyah Abbas-Hanif, Alan Boyd, Renata Crome, Alexander Douglas, Sheuli Porkess, Penny Ward
1. Medicines and Healthcare products Regulatory Agency. MHRA joins international partnerships to set global standards for medicines and medical devices regulation. 16/6/22 2022. https://www.gov.uk/government/news/mhra-joins-international-partnerships... (accessed 4/8/22.
2. Office for Life Sciences. Life Science Competitiveness Indicators. 1/4/17. https://assets.publishing.service.gov.uk/government/uploads/system/uploa... (accessed 4/8/22.
3. MHRA. CODE OF PRACTICE FOR CHAIRMEN AND MEMBERS OF THE COMMISSION ON HUMAN MEDICINES, CERTAIN COMMITTEES AND EXPERT ADVISORY GROUPS. https://assets.publishing.service.gov.uk/government/uploads/system/uploa... (accessed 10/8/22.
4. MHRA. The MHRA are seeking views to strengthen conflicts of interest policy for independent advisors. https://www.gov.uk/government/news/the-mhra-are-seeking-views-to-strengt... (accessed 10/8/22.
Competing interests: Allyah Abbas-Hanif European Medical Director, Aimmune Therapeutics, part time employee Head of Clinical Development, Mirzyme Therapeutics, pro bono Global Medical Expert/ Medical Director, Bayer, consultant and then employee Trustee, Better Community Business Network Renata Crome Scientific Advisor and Mentor for Whalebay & Co ( Rotterdam) a life sciences investment consultancy . I undertake evaluations of approx 2-3 new projects per month ( primarily originating from academia or biotechs based in Holland ) , and act as mentor to those selected for investment funding. All conducted under NDAs and no conflicts with FPM Trustee & Board Member of the PTEN Research Foundation , a charity created to find treatments for the rare disease PTEN hamartoma tumor syndrome I hold shares in Roche, GSK and Gilead . Sandy Douglas -I am likely to receive income, through the University of Oxford, from out-licensing of University-owned intellectual property to which I have contributed. This includes patents relating to manufacturing of simian adenovirus-vectored vaccines licensed to AstraZeneca, and relating to a malaria vaccine candidate licensed to Serum Institute of India. -I hold current research funding from AstraZeneca -I received consultancy payments from AstraZeneca in 2020-21 -A close family member has a significant shareholding in ResMed, a medical device company primarily producing non-invasive ventilation and CPAP machines. Dr Flic Gabbay President of the Faculty of Pharmaceutical Medicine of the three Royal Colleges of Physicians of the UK. Fellow of the Academy of Medical Sciences and member of the Forum Committee. Senior Partner and shareholder of tranScrip, a drug development organisation which has been in receipt of funding for consultative, clinical and regulatory work on treatments. Shareholder in Phico Therapeutics a company developing novel antibiotics. Professor Penny Ward Owner and Director of PWG Consulting (Biopharma) Ltd a privately held consulting company advising clients on drug development and regulatory strategy. Recipient of pension payments from Pfizer and Roche. Dr Sheuli Porkess Vice-President & Trustee of Faculty of Pharmaceutical Medicine of the three Royal Colleges of Physicians of the UK. Founder & Chief Medical Officer Actaros Consultancy Limited, a medical affairs and life science policy consultancy which works with pharmaceutical companies and pharmaceutical industry trade associations. Senior Associate, OVID HEALTH Visiting Lecturer in Pharmaceutical Medicine, Kings College London Member of Scientific Advisory board for C2-Ai, a healthcare analytics company. Member of Advisory Group for PrinciPIL study. Member of NIHR MRC Multiple Long-Term Conditions Clusters Programme Steering Group. Member of UK Pharmacogenetics and Stratified Medicine Network Steering Committee. Global Fellow in Medicines Development, International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine. Professor Alan Keith Boyd BSc (Hons) MB ChB FRSB FFFLM FRCP FFPM FMedSci • Boyds International Life Sciences Group Ltd (UK) – CEO, Director and majority shareholder • Alan Boyd Consultants Ltd (UK) – CEO, Director and majority shareholder • Boyd Consultants Ltd (Ireland) – Director and majority shareholder • Boyd Consultants Inc (USA) – President and majority shareholder Through the above companies I provide consultancy services to pharmaceutical & biotechnology companies and university life science departments & medical schools in relation to medicines and medical devices development. • Celentyx Ltd (UK) - Non-Executive Director and shareholder • Transine Therapeutics Ltd (UK) - Non-Executive Director and share-option holder