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

Key Information

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. 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.

Early life and education

[edit]

Michael Rawlins was born in Shrewsbury, Shropshire on 28 March 1941.[1][2] 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.[3] He attended Uppingham School, Rutland, with David Li and left there in 1959.[4] In 1962 he graduated first class from University of London.[5] He obtained his medical degree from St Thomas' Hospital in 1965.[6]

Career

[edit]

Rawlins completed his house jobs in 1967; firstly, in surgery at St Thomas' and then in medicine at Portsmouth.[5] His subsequent senior house job was at the Brompton Hospital, London.[5] The following year he gained membership of the Royal College of Physicians (RCP) of London.[5] 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.[2] In 1973, he was appointed the Ruth and Lionel Jacobson professor of clinical pharmacology at the University of Newcastle upon Tyne.[2] There, he delivered his inaugural lecture in 1974, on "Variability in Response to Drugs", and remained at Newcastle until 2006.[2]

From 1977 to 1983 he was a member of the National Committee on Pharmacology.[2] 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.[2] 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.[2] In 1998, he was appointed chairman of the Advisory Council on the Misuse of Drugs and served it until 2008.[7]

Rawlins was chair of the National Institute for Clinical Excellence (NICE) from its foundation in 1999 until April 2013.[2][7] There, one of his early roles was the decision not to approve wide use of Relenza for flu.[3] Earlier he had clarified the difference of cost-effectiveness from affordability.[8]

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.[9] From 2012 to 2019 he was chair of UK Biobank.[10][11] In November 2014 the Medicines and Healthcare Products Regulatory Agency (MHRA) announced the appointment of Rawlins as its new chair, succeeding Gordon Duff.[12][13] The appointment was renewed for a further three years in 2017.[14]

Eponymous lectures

[edit]

Rawlins delivered several eponymous lectures at the RCP, including the Bradshaw Lecture in 1986.[15] In 1994 he gave the RCP's William Withering lecture.[16] 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".[16] In 2006 he gave the RCP'S Samuel Gee Lecture.[15]

De Testimonio

[edit]

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.[17] 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.[18] The problem with RCTs, he stated, is that they are too generalised.[19] He pointed out that science includes the not so exact but important "judgement".[20] Rawlins quoted William Blake's observation .. "God forbid that truth should be confined to mathematical demonstration",[18] 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.[20]

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.[20]

Honours and awards

[edit]

Rawlins became a Fellow of the RCP London in 1977, and 10 years later became Fellow of the Royal College of Physicians of Edinburgh.[5] He gained Fellowship of the Faculty of Pharmaceutical Medicine in 1989 and of the Academy of Medical Sciences in 1998.[5]

He was awarded the Hutchinson Medal in 2003, and the Galen Medal in 2010.[21] In 2012 he received the Prince Mahidol Award for his contribution to medicine.[22] Zenith Global Health awarded him their Lifetime Achievement Award in 2019.[23]

Rawlins was knighted in the 1999 New Year Honours for services to the improvement of patient protection from the side-effects of medicines, and was appointed Knight Grand Cross of the Order of the British Empire (GBE) in the 2017 Birthday Honours for services to the safety of medicines, healthcare, and innovation.[24]

Personal and family

[edit]

In 1963 he married Elizabeth Hambly, a nurse; they divorced in 2005.[1] In 1981 he became the first chairman of the Newcastle upon Tyne SDP and played an active part in the founding and development of the new party.

Death

[edit]

Rawlins died in Darlington from sepsis and heart failure on 1 January 2023, at the age of 81.[3][25] At the time of his death he was honorary professor at the London School of Hygiene & Tropical Medicine, University of London, and emeritus professor at the University of Newcastle upon Tyne.[7] Rawlins is survived by his daughters Vicky, Lucy, and Suzannah, and eight grandchildren.[3]

Selected publications

[edit]

Articles

[edit]
  • Rawlins, MD (12 October 1974). "Variability in Response to Drugs". British Medical Journal. 4 (5936): 91–94. doi:10.1136/bmj.4.5936.91. PMC 1612144. PMID 4607336.
  • Rawlins, MD. (June 1986). "Spontaneous reporting of adverse drug reactions". The Quarterly Journal of Medicine. 59 (230): 531–534. ISSN 0033-5622. PMID 3749447.
  • Rawlins, MD (January 1995). "Pharmacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994". Journal of the Royal College of Physicians of London. 29 (1): 41–9. doi:10.1016/S0035-8819(25)00659-2. PMC 5401160. PMID 7738878.
  • Rawlins, MD (December 2008). "De Testimonio: on the evidence for decisions about the use of therapeutic interventions". Clinical Medicine. 8 (6): 579–588. doi:10.7861/clinmedicine.8-6-579. ISSN 1470-2118. PMC 4954394. PMID 19149278.

Books

[edit]

References

[edit]

Further reading

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Michael Rawlins

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Sir Michael David Rawlins GBE (28 March 1941 – 1 January 2023) was a British clinical pharmacologist renowned for his contributions to and drug safety regulation. He served as the founding chairman of the from its establishment in 1999 until 2013, where he championed the use of clinical and cost-effectiveness analyses to guide healthcare decisions in the . Rawlins pioneered the classification of adverse drug reactions into type A (predictable and dose-related) and type B (unpredictable and idiosyncratic) categories, a framework that remains foundational in . His tenure at NICE, while instrumental in standardizing treatment guidelines and curbing inefficient prescribing, sparked ongoing debates over and the denial of certain therapies deemed uneconomical, underscoring tensions between scientific rigor and patient access.60760-1/fulltext) Earlier, he chaired the Committee on Safety of Medicines from 1993 to 1998, influencing regulatory policies on pharmaceuticals amid controversies over approvals and misuse controls. Rawlins received numerous honors, including Knight Grand Cross of the in 2017 for services to medicines safety and healthcare.

Biography

Early life and education

Michael David Rawlins was born on 28 March 1941 in , . He received his early at Hawtreys School in and in , where he developed an interest in . Rawlins then studied medicine at Medical School in , graduating with honours in 1965 after earning multiple academic prizes. During his initial years there, he devoted significant time to music, including the hospital .

Personal life and family

Rawlins married Elizabeth Hambly, a nurse whom he met during his time at St Thomas's Hospital, in 1963; the couple divorced in 2005. They had three daughters: Victoria (Vicky), who serves as an assistant head at a preparatory school; Lucy; and Susannah (Suzannah). Rawlins was described as a devoted father and grandfather to his eight grandchildren, named Laura, Emily, Annie, Lottie, Tilly, Alfie, Sam, and Daisy. Following his death on 30 December 2022, he was survived by his former wife and daughters.

Professional Career

Academic and clinical roles

Rawlins completed his medical degree at in in 1965, earning honours and multiple prizes, before undertaking postgraduate training in and general at . In 1973, he was appointed the founding Ruth and Lionel Jacobson Professor of at , establishing the discipline there at age 32, and held the role until 2006. Simultaneously, from 1973 to 2006, Rawlins served as consultant clinical pharmacologist and physician specializing in at hospitals, where he developed a dedicated treatment unit. Following retirement from these positions, he was designated Emeritus Professor of at and Honorary Professor at the London School of Hygiene and Tropical Medicine.

Regulatory positions

Rawlins served as a member of the United Kingdom's Committee on Safety of Medicines (CSM) starting in 1980, initially as a subcommittee chairman and vice-chair before becoming the full committee's chair from 1993 to 1998. The CSM advised the licensing authority on the safety, quality, and efficacy of medicines, playing a key role in post-marketing surveillance and regulatory decisions prior to the formation of the Medicines and Healthcare products Regulatory Agency (MHRA) in 2003. From 1998 to 2008, he chaired the Advisory Council on the Misuse of Drugs, an independent body that provided evidence-based recommendations to the government on controlled substances, including classification and policy on drugs of abuse. In 2014, Rawlins was appointed chair of the MHRA, taking office in December and serving until 2020; the MHRA is the responsible for regulating medicines, devices, and blood components in the , ensuring their safety, quality, and efficacy through licensing, inspections, and . During his tenure, he emphasized adaptive regulatory approaches to balance innovation with public safety, particularly in response to emerging challenges like advanced therapies.

Leadership at NICE


Sir Michael Rawlins served as the founding chairman of the National Institute for Health and Care Excellence (NICE), originally established as the National Institute for Clinical Excellence, from its inception on 1 April 1999 until April 2013. In this role, he shaped NICE into a pivotal organization for evidence-based guidance on clinical practices, health technologies, and public health interventions within the National Health Service (NHS). Rawlins prioritized technical rigor, stakeholder dialogue, effective communication, and value-for-money assessments in NICE's operations, establishing standardized methods for evaluating treatments using quality-adjusted life years (QALYs) to balance clinical benefits against costs. Under his leadership, NICE expanded its remit beyond initial clinical audits to include systematic technology appraisals and interventional procedures guidance, issuing recommendations that influenced NHS adoption of pharmaceuticals, devices, and procedures. He advocated for independent committee processes to ensure decisions were driven by rather than political or commercial pressures, fostering transparency through public consultations and detailed rationales. During Rawlins's tenure, NICE navigated early challenges, including resource constraints and public scrutiny, while achieving international recognition as a model for . In 2009, his term was extended by two years amid ongoing debates over NICE's role, underscoring his influence in safeguarding the institute's independence. By 2013, NICE had produced hundreds of guidelines and appraisals, standardizing care pathways and promoting efficient allocation of NHS funds based on probabilistic modeling and . Rawlins's emphasis on causal from randomized trials and observational studies, while critiquing over-reliance on rigid thresholds, solidified NICE's commitment to causal realism in policy.

Scientific Contributions

Advances in clinical pharmacology

Rawlins advanced the field of through his foundational research at , where he held the Ruth and Lionel Jacobson Professorship from 1973 to 2006 and established a prominent center for the discipline. His work emphasized empirical analysis of drug effects in human populations, focusing on variability in responses and mechanisms of harm. A key contribution was the development of the Rawlins-Thompson classification of adverse drug reactions (ADRs), first outlined in the late 1970s, which categorized reactions into Type A (predictable, dose-related, and augmented pharmacological effects, accounting for ~80% of ADRs) and Type B (unpredictable, idiosyncratic, often immune-mediated or genetically influenced). This framework, detailed in publications such as the 1981 British Medical Journal article on ADRs, provided a causal structure for identifying risks, shifting focus from rare anomalies to common, preventable extensions of therapeutic actions. It influenced protocols globally by prioritizing dose adjustment and patient-specific factors over blanket warnings. Rawlins also pioneered research on inter-individual variability in drug responses, co-authoring Variability in Human Drug Response with Stephen E. Smith in 1973, which dissected influences including disease states, genetic polymorphisms, racial differences, , and . His studies quantified how these factors alter and , advocating for tailored dosing based on observable data rather than uniform assumptions; for instance, he highlighted age-related declines in hepatic metabolism leading to higher plasma concentrations of drugs like . This body of work, spanning decades of peer-reviewed outputs, underscored causal mechanisms in clinical settings, informing safer prescribing practices and reducing iatrogenic harm. Through these efforts, Rawlins elevated from descriptive observation to a rigorous, data-driven science, mentoring generations of researchers and integrating epidemiological methods to detect subtle safety signals in real-world use. His emphasis on first-principles evaluation of drug effects—prioritizing verifiable incidence rates over anecdotal reports—remains foundational, though later critiques noted the classification's limitations in capturing mechanisms.

Advocacy for evidence-based medicine

Throughout his career, Sir Michael Rawlins championed (EBM) by emphasizing rigorous, context-specific evaluation of clinical data to inform therapeutic decisions, particularly during his tenure as founding chairman of the (NICE) from 1999 to 2013. Under his leadership, NICE established a systematic framework for appraising health technologies, synthesizing evidence from randomized controlled trials (RCTs), observational studies, systematic reviews, and economic analyses to produce guidelines that prioritized clinical effectiveness and cost-efficiency for the (NHS). This approach aimed to mitigate arbitrary prescribing and ensure equitable access to interventions supported by verifiable outcomes, influencing over 200 technology appraisals by 2013. Rawlins critiqued dogmatic aspects of EBM, notably in his 2008 Harveian Oration "De testimonio," where he rejected hierarchical models of that elevate RCTs above other sources as "illusory" and placing RCTs on an "undeserved pedestal." He contended that such pyramids mislead by implying uniform superiority, arguing instead that validity depends on to the decision at hand—RCTs excel in controlled but falter for rare conditions, heterogeneous populations, or post-marketing —necessitating judgment on whether data from experimental or observational origins are "fit for purpose."61930-3/fulltext) This stance promoted pragmatic EBM, integrating like cohort studies for broader applicability, as reflected in NICE's evolving methodologies under his guidance. Rawlins' advocacy extended to regulatory and academic spheres, where he urged regulators and clinicians to transcend RCT-centric approvals, advocating for conditional licensing based on surrogate endpoints or Bayesian adaptive designs when definitive trials are infeasible. His views, drawn from decades in , underscored from diverse datasets while cautioning against uncritical acceptance of industry-sponsored trials, fostering a more resilient EBM paradigm resistant to biases in selective reporting.

Controversies and Criticisms

NICE rationing decisions

As chairman of the National Institute for Health and Care Excellence (NICE) from its inception in 1999 until 2013, Michael Rawlins oversaw the development of technology appraisals that effectively rationed access to new medicines within the National Health Service (NHS) by recommending against funding for interventions deemed insufficiently cost-effective. NICE employed a threshold of approximately £20,000–£30,000 per quality-adjusted life year (QALY) gained, prioritizing treatments that maximized health benefits across the population amid finite NHS resources.60760-1/fulltext) Rawlins defended this approach as transparent and evidence-based, arguing it prevented arbitrary "postcode lotteries" in care while enabling broader access to proven therapies, though critics contended it undervalued innovative drugs for smaller patient groups. Prominent rationing decisions included NICE's 2002 recommendation against routine NHS funding for beta-interferons (such as interferon beta-1a and beta-1b) and glatiramer acetate for relapsing-remitting multiple sclerosis, citing incremental cost-effectiveness ratios exceeding £30,000 per QALY over a 20-year horizon, despite modest clinical benefits in delaying disability. This ruling, which addressed prior inconsistent regional prescribing, provoked backlash from patient advocacy groups and manufacturers for allegedly denying treatments that could extend quality life years, leading NICE to reconsider evidence but ultimately uphold restrictions initially. Similarly, in 2008–2010, NICE rejected lapatinib (Tyverb) in combination with capecitabine for HER2-positive advanced breast cancer previously treated with trastuzumab, determining the regimen's cost per QALY at over £45,000, thereby barring NHS funding for an estimated 2,000 patients despite evidence of progression-free survival gains. GlaxoSmithKline contested the decision, highlighting trial data showing a median progression-free survival extension of 2–4 months, but NICE prioritized overall NHS affordability. These appraisals drew criticism for rigidity, with pharmaceutical firms and clinicians accusing NICE of imposing a "fourth hurdle" beyond clinical , , and by factoring in societal costs, potentially stifling . Patient organizations, such as those for , argued that QALY metrics inadequately captured individual suffering or end-of-life value, prompting parliamentary scrutiny and calls for higher thresholds for rare or terminal conditions. Rawlins countered that such decisions were not arbitrary but necessary prioritization, emphasizing that approving unaffordable drugs would divert funds from more effective alternatives benefiting larger numbers; he noted instances where manufacturers withheld long-term data, complicating assessments. In response to broader critiques, NICE under Rawlins introduced end-of-life criteria in 2009, permitting thresholds up to £30,000–£50,000 per QALY for patients with short and substantial uncertainty in benefits, though this did not retroactively alter prior denials.60760-1/fulltext) Even approved recommendations faced implementation hurdles, as some NHS trusts delayed or denied access to NICE-endorsed drugs to preserve budgets, prompting Rawlins in 2012 to urge clinicians to pursue legal action against non-compliant bodies, citing violations of statutory duties under the Act 2006. He highlighted "numerous" such cases, including reluctance to fund high-cost implants like dexamethasone for , underscoring tensions between central guidance and local fiscal pressures. Rawlins maintained that NICE's framework fostered equitable , rejecting euphemisms for while advocating its respectability in a publicly funded system constrained by taxpayer limits.

Debates on pharmaceutical innovation and cost-effectiveness

Rawlins, as chairman of NICE from 1999 to 2013, presided over appraisals that frequently rejected or restricted access to high-cost pharmaceuticals deemed insufficiently cost-effective, sparking debates over whether such decisions undermined incentives for research and development (R&D) in novel therapies. The pharmaceutical industry contended that NICE's implicit threshold of approximately £20,000–£30,000 per quality-adjusted life year (QALY) penalized breakthrough innovations, particularly for rare diseases or advanced cancers where incremental benefits were modest relative to prices, potentially deterring investment in high-risk R&D pipelines. Critics, including industry representatives, argued this approach favored incremental "me-too" drugs over transformative ones, as evidenced by rejections of drugs like multiple myeloma treatments despite clinical promise. Rawlins countered that NICE's methodology, grounded in probabilistic modeling of clinical trial data and opportunity cost considerations, promoted efficient resource allocation within finite NHS budgets, rather than stifling genuine innovation. He maintained that unsubstantiated premiums for "innovation" would exacerbate inequities by diverting funds from proven interventions, emphasizing in a 2004 analysis with Anthony Culyer that thresholds derived empirically from historical decisions reflected societal willingness to pay, not arbitrary barriers. In 2008, Rawlins publicly lambasted the industry for "perverse incentives" tying executive compensation to sales volumes over therapeutic advancement, accusing firms of inflating prices to maximize profits rather than aligning with patient value, which the Association of the British Pharmaceutical Industry rejected as overlooking R&D costs exceeding £500 million per new drug. These tensions influenced policy shifts toward (VBP), implemented in 2014, which Rawlins endorsed as a framework to reward through metrics like wider societal benefits or future therapeutic potential beyond strict QALYs. He acknowledged in 2010 that NICE appraisals could evolve to better incorporate and end-of-life modifiers—such as doubled QALY weighting for patients with less than one year —without abandoning cost-effectiveness, though industry sources claimed even adjusted thresholds failed to offset lost revenues from negative guidance. Empirical reviews under Rawlins' tenure suggested NICE approvals correlated with higher uptake of efficient drugs, but a 2009 interview reflection indicated overall NHS costs rose due to endorsements of effective therapies, complicating claims of net disincentives to . Debates persisted, with some economists arguing the threshold was conservatively low relative to per capita GDP (typically 1–2 times), potentially under-valuing long-term R&D spillovers, while Rawlins prioritized causal evidence from randomized trials over speculative arguments.

Recognition and Legacy

Honours and awards

Rawlins received the Lilly Prize and Medal from the British Pharmacological Society in 1997 for his contributions to research. He was knighted in the for services to improving protection from the side effects of medicines. In 2005, he was elected an Honorary Fellow of the British Pharmacological Society. Rawlins was awarded the Prince Mahidol Award for Medicine in 2012, recognizing his pioneering application of evidence-based methods to evaluate healthcare efficiency and cost-effectiveness. He was appointed Knight Grand Cross of the (GBE) in the 2017 for services to the safety of medicines, healthcare, and innovation. In 2019, Rawlins received a Lifetime Achievement Award from Zenith Global Health for his sustained contributions to and . Rawlins held several distinguished fellowships, including Fellow of the Academy of Medical Sciences (FMedSci) and Fellow of the British Pharmacological Society (FBPhS), as well as Honorary Fellowship of the Royal Statistical Society in 2009. He was granted numerous honorary degrees, among them from the in 2015 and the in 2017.

Eponymous lectures

Rawlins delivered the Bradshaw Lecture at the Royal College of Physicians in 1986, a prestigious annual address honoring historical contributions to medicine. In 1994, he presented the William Withering Lecture at the same institution, focusing on themes related to therapeutic advancements, named after the 18th-century physician known for his work on digitalis. His most notable eponymous delivery was the Harveian Oration in 2008, the Royal College of Physicians' highest honor, titled De testimonio: on the evidence for decisions about the use of therapeutic interventions. In this address, Rawlins critiqued overreliance on randomized controlled trials, advocating for Bayesian statistical methods to better incorporate prior knowledge and in clinical decision-making, as detailed in its subsequent publication in .61740-9/fulltext) These invitations underscored Rawlins' influence in and , with the Harveian Oration particularly highlighting his push for pragmatic, data-driven approaches over rigid evidentiary hierarchies.

Death and posthumous impact

Sir Michael Rawlins died on 1 January 2023 in , , from and , at the age of 81. Following his death, tributes from medical and regulatory bodies underscored his foundational influence on evidence-based . The National Institute for Health and Care Excellence (), which Rawlins chaired from its inception in 1999 until 2013, described him as a pioneer who shaped its methodology for evaluating medicines and technologies based on clinical efficacy and cost-effectiveness. The Association of the British highlighted his enduring contributions to NHS care and advocacy for the UK's life sciences sector, crediting him with advancing medicines regulation and . The Royal Society of Medicine and British Pharmacological Society similarly praised his leadership in and commitment to rational prescribing, noting his role in establishing systematic approaches to drug safety and utilization. Rawlins' posthumous impact persists through NICE's institutional framework, which continues to apply his principles of probabilistic decision-making and threshold-based to guide NHS funding decisions on pharmaceuticals and interventions. His advocacy for integrating over rigid randomized controlled trials has influenced ongoing debates and policies on adaptive pathways for drug approval, as evidenced by persistent references to his Mansel Williams Oration in regulatory discussions. These elements affirm his legacy in promoting causal, data-driven realism in healthcare amid pressures for and fiscal restraint.

Publications

Books

Rawlins co-authored Variability in Human Drug Response with Stephen E. Smith, published by Butterworths in 1976 (ISBN 978-0-407-43301-4). He co-authored Patients, the Public and Priorities in Healthcare with Peter Littlejohns, published by Radcliffe Publishing in 2009 (ISBN 978-1-84619-387-3). Rawlins authored Therapeutics, Evidence and Decision-Making, published by Hodder Arnold (CRC Press) on July 29, 2011 (ISBN 978-1-85315-947-3). The book provides guidance for decision-makers on using, assessing, and appraising evidence underlying therapeutic interventions.

Key articles and reports

Rawlins' 2008 Harveian Oration, published as "De testimonio: on the evidence for decisions about the use of therapeutic interventions" in The Lancet, critiqued the prevailing evidence hierarchy that prioritizes randomized controlled trials, advocating instead for Bayesian integration of multiple data sources—including observational studies, mechanistic understanding, and real-world evidence—to inform therapeutic choices.61930-3/fulltext) This work emphasized causal inference over rigid empiricism, influencing debates on regulatory approvals and cost-effectiveness assessments. In "Pharmacovigilance: paradise lost, regained?" (BMJ, 1995), Rawlins examined the history and resurgence of post-marketing surveillance systems following regulatory failures like thalidomide, stressing the need for proactive, population-based monitoring of adverse drug reactions to balance innovation with safety. Rawlins co-authored "Variability in response to drugs" (BMJ, 1974), which analyzed pharmacokinetic and pharmacodynamic factors driving inter-individual differences in drug efficacy and toxicity, underscoring the limitations of average population responses in clinical practice. He contributed to the 2012 WHO/IUPHAR collaborative report " in , teaching and research," which outlined core curricula and roles for clinical pharmacologists in optimizing drug use, education, and policy amid rising and resistance concerns.

References

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