A tribute to Dr Frank Wells FFPM FRCP

Dr Francis “Frank” Wells died peacefully at the age of 84 years on 6th July 2020 in a nursing home near Ipswich. Frank’s commitment and achievements in encouraging and researching clinical research ethics and integrity lives on.

A graduate from University College, London Frank began his career as a General Practitioner in Ipswich. It was in General Practice where he began clinical research. Throughout his career Frank was an active British Medical Association (BMA) member, an early member of their Pharmaceutical Physicians Group Committee and was elected undersecretary of the BMA.

During the late 1970s he worked with Owen Wade to modernise the British National Formulary; the new format being released in 1981. He became the Medical Director of the Association of the British Pharmaceutical Industry (ABPI) in 1986, a role which he continued until he “retired” in 1996. He joined the British Association of Pharmaceutical Physicians (BrAPP) in 1980s and was an early member of the Faculty of Pharmaceutical Medicine at its foundation in 1989 and was elected an FPM Fellow in 1995.

After retiring in 1996, Frank served on his own Local Research Ethics Committee, and was chairman of an NHS Trust, together with an experimental medicines company and the Wales Cancer Bank. He was the chairman of the European Forum for Good Clinical Practice (EFGCP) Ethics Working Party and was chairman of the BMA Retired Members Forum. He was a Freeman of the City of London and was a honorary secretary of the Livery Committee of the Worshipful Society of Apothecaries.

He remained an active member of BrAPP, a regular attender at meetings and a contributor to AGMs. For many years he wrote a regular column “Musings” in the BrAPP journal about travel on public transport. In one memorable column he described writing it sitting on the balcony of the champagne bar at London St Pancras railway station! He knew all the bus routes in London and was always ready to advise about train routes throughout Europe. In his last illness he was comforted by watching travel programmes on the television, reliving journeys he had made.

But his career was marked by a drive to ensure the integrity of clinical research and appropriate use of medicines. These ideals continued from his time as Medical Director in the ABPI and throughout his “retirement”. In 1993 he and Dr Richard Tiner (past president of the FPM) met with Sir Iain Chalmers, a leading founder of the Cochrane Collaboration in 1993. This is a British international charitable organisation formed to organise medical research findings to facilitate evidence-based choices about health interventions involving health professionals, patients, and policy makers. They took the initial steps to enable the results of clinical trials to be fully published and accessible to the public. In 1998 Frank set up the Faculty of Pharmaceutical Medicine the Ethics Committee. The committee reported that:

“Pharmaceutical physicians have a particular ethical responsibility to ensure that the evidence on which doctors should make their prescribing decisions is freely available . . . the outcome of all clinical trials on a medicine should be reported”

However, it took some years to achieve the publication of the results of clinical trials, in 2014. It then became mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by the European Medicines Agency (EMA). There remains further work, a legal challenge remains in the European Court of Justice on the EMA request for the clinical study reports to be published.

After “retirement” Frank turned to investigating and prevention fraud in clinical trials. He formed the company MedicoLegal Investigation (MLI) in July 1996, with a former detective chief inspector Peter Jay to take up the challenge of reducing fraud and misconduct in clinical research. In 1998, Jonathan Jay formerly a sergeant in the Army Special Investigation Branch, joined the team. Jonathan recalls how their enquiries were reminiscent of complex cases of Sherlock Holmes and Dr Watson. They have since investigated more than 80 studies, 27  doctors have faced disciplinary hearings at the General Medical Council (GMC), and 26 were found guilty of Serious Professional Misconduct. They gained professional and industry support from medical royal colleges, the ABPI, the GMC and the BMA. In 2000 the company achieved recognition for its success in tackling research fraud. The ABPI Board of Management demonstrated its support by nominating Mike Wallace (a former vice-president of ABPI) and Dr Richard Tiner (future President of the FPM) to join the Board of MLI, and Peter Jay was awarded Honorary Membership of the Faculty. Dr Jane Barrett joined MLI as the new consultant medical advisor and director in 2002.

The battle for integrity in clinical research has now encompassed more than simple falsification of data to “conditioning” of the reporting of the evidence from clinical studies. The detection of this type of fraud requires detailed statistical analysis and depends on the full publication of the clinical report forms.

We expect that Frank would have welcomed the 2019 outcome of the Government Response to the House of Commons Science and Technology Committee Report on Research Integrity: Clinical Trials Transparency. There was an explicit re-commitment to tackling clinical trials transparency. The Health Research Authority (HRA) should be provided with funding and power to establish a national audit programme of clinical trials transparency, including the publication of a single official list of which UK trials have published results. This would include publicly funded clinical research where rates of publication remain too low.

This tribute has been prepared by Jane Barrett (past chair of BrAPP) MBBS, AKC, LLM and Tim Higenbottam DSc, MA, MD, FRCP, PFPM, with input from David Cloke and Dr John Bolodeoku.

It is provided for information and does not constitute advice or represent official FPM views or policy.