Michael Rawlins

In it, contrary to the widely held belief that digitalis would unlikely pass modern day licensing regulations, he said of Withering's 1785 An account of the foxglove and some of its medical uses ... "Its contents would do justice to an expert report accompanying a Product Licence application to the drug regulatory authority of any state in the European Union".

Sir Michael David Rawlins (28 March 1941 – 1 January 2023) was a British clinical pharmacologist and emeritus professor at the University of Newcastle upon Tyne.

Michael Rawlins was born in Shrewsbury, Shropshire on 28 March 1941.

His father was the Reverend Jack Rawlins, vicar of Northwood-on-Trent in Staffordshire, and his mother was Evelyn Daphne Douglas-Hamilton who following the death of his father later married a general practitioner.

He attended Uppingham School, Rutland, with David Li and left there in 1959.

In 1962 he graduated first class from University of London.

He obtained his medical degree from St Thomas' Hospital in 1965.

Rawlins completed his house jobs in 1967; firstly, in surgery at St Thomas' and then in medicine at Portsmouth.

His subsequent senior house job was at the Brompton Hospital, London.

The following year he gained membership of the Royal College of Physicians (RCP) of London.

After spending a year lecturing at St Thomas' he took up a senior register post at the Hammersmith followed by a year as visiting research fellow at the Karolinska Institute in Stockholm.

In 1973, he was appointed the Ruth and Lionel Jacobson professor of clinical pharmacology at the University of Newcastle upon Tyne.

There, he delivered his inaugural lecture in 1974, on "Variability in Response to Drugs", and remained at Newcastle until 2006.

From 1977 to 1983 he was a member of the National Committee on Pharmacology.

Rawlins became a Fellow of the RCP London in 1977, and 10 years later became Fellow of the Royal College of Physicians of Edinburgh.

In 1980 he became a member of the Committee on Safety of Medicines and was appointed its chairman in 1993; a position he retained until 1998.

Rawlins delivered several eponymous lectures at the RCP, including the Bradshaw Lecture in 1986.

He was a member of the Committee on Toxicity from 1989 to 1992, and the Standing Group on Health Technology Assessment from 1993 to 1995.

During his medical career he chaired several executive agencies including the Committee on Safety of Medicines from 1993 to 1998, followed by the National Institute for Health and Care Excellence (NICE) for 14 years from its formation in 1999 and then the Medicines and Healthcare products Regulatory Agency (MHRA) for six years from 2014.

In 1994 he gave the RCP's William Withering lecture.

In 1998, he was appointed chairman of the Advisory Council on the Misuse of Drugs and served it until 2008.

For his contributions to protecting people from the side-effects of medicines he was knighted in 1999, and for his services to the safety of medicines, healthcare, and innovation he was appointed Knight Grand Cross of the Order of the British Empire (GBE) in 2017.

Rawlins was chair of the National Institute for Clinical Excellence (NICE) from its foundation in 1999 until April 2013.

There, one of his early roles was the decision not to approve wide use of Relenza for flu.

Earlier he had clarified the difference of cost-effectiveness from affordability.

In 2006 he gave the RCP'S Samuel Gee Lecture.

Rawlins delivered several eponymous lectures during his medical career including the 2008 Harveian Oration at the Royal College of Physicians (RCP), where he argued that there were other ways of collecting useful clinical evidence other than only randomised controlled trials and he encouraged a range of methods to provide a more holistic evaluation.

In his 2008 Harveian Lecture, titled "De Testimonio: on the evidence for decisions about the use of therapeutic interventions", while acknowledging the value of good quality trials, he argued that there were also other ways of collecting useful clinical evidence other than only randomised controlled trials (RCT) and he encouraged a range of methods to provide a more holistic evaluation.

The lecture called for abandoning hierarchy of evidence at a time when Rawlins headed NICE, the UK's main independent agency whose purpose was to assess scientific evidence of medical treatments.

The problem with RCTs, he stated, is that they are too generalised.

He pointed out that science includes the not so exact but important "judgement".

Rawlins quoted William Blake's observation ..

"God forbid that truth should be confined to mathematical demonstration", and said in his lecture:

"The notion that evidence can be reliably placed in hierarchies is illusory. Decision makers need to assess and appraise all the available evidence irrespective of whether it has been derived from randomized controlled trials or observational studies; and the strengths and weaknesses of each need to be understood if reasonable and reliable conclusions are to be drawn."

According to philosopher John Worrall, if other physicians in the field of evidence based medicine held similar views to Rawlins, his [Worrall's] own philosophical work on evidence based medicine might not be required.

In 2010, he helped establish the all-party parliamentary group for Huntington's disease in the UK Parliament, supported by more than 40 MPs and peers.

From 2012 to 2014 he was president of the Royal Society of Medicine.

From 2012 to 2019 he was chair of UK Biobank.

In November 2014 the Medicines and Healthcare Products Regulatory Agency (MHRA) announced the appointment of Rawlins as its new chair, succeeding Gordon Duff.

The appointment was renewed for a further three years in 2017.