PHARMACOGENOMICS
whether insurance companies and employers would have access. Issues of child consent, social stigma and the increased prospect of legal disputes all point to the sensitivity required in this area. There is also a debate to be had around the status of genetic testing that reveals information that would be relevant to other family members. In the recent review of the Nuffield Report outlined above, the BMJ argued that issues related to data need to be debated without delay.9
Here, the author argued that the
report “falls short of adequately addressing issues with reference to DNA collection in pharmaceutical company-sponsored clinical drug trials. In particular, the report fails to acknowledge the extent of the current routine practice of collecting and storing DNA samples and data during clinical drug trials.” In terms of the current location of pharmacogenomics activity, Allied Market Research’s report concluded that hospitals and clinics accounted for two-thirds of the total market in 2017 and that North America is currently the major hub of activity - contributing around 40% of global market share. Higher disposable income, better infrastructure, high-end healthcare facilities, and government-based initiatives were all cited by Allied as factors that favour the implementation of a genomics-enabled pharmaceutical ecosystem.
Implications for the UK
The UK, with the NHS sitting at the heart of its healthcare system, is well-placed to drive the global pharmacogenomics agenda as part of a wider shift towards personalised medicine. The large teaching hospitals that characterise the UK system are especially suited to take advantage of genomics since they control all key elements required to integrate genetic data with patients’ electronic medical records. It will prove far harder for a genomic-based system to develop in countries where the healthcare system is fragmented and siloed. The UK also benefits from the fact that it is a pioneer in the field of genetic testing and has a positive top-down vision for the sector. In a recent interview with the FT,10
the UK’s
chief medical officer, Professor Dame Sally Davies, expressed her pride at the fact that the UK was the first country in the world to sequence 100,000 genomes. Arguing that the UK has the ability to legitimately lead the world in the introduction of personalised medicine at a national scale, she added: “The introduction of genomic- based medicine is the most ambitious project I have been involved in and the one with the most far-reaching impact. We need to embed (genomics) into the fabric of NHS services.” These comments chime with the findings of the influential Topol Report,11 commissioned in 2019 on behalf of the Secretary of State for Health and Social Care. Among many forecasts for the future shape of healthcare in the UK, the report sets out a holistic patient-centric vision for genomics by
quoting Sir Nilesh Samani as saying: “In the foreseeable future, information from an individual’s DNA sequence will become part of their medical record and used to inform their healthcare in many different ways throughout their life course.” Topol points to the fact that the NHS has created a new Genomic Medicine Service that will provide a national genomic testing service for all specialities and equitable patient access throughout England. It also echoes our observations about the importance of improving clinician understanding of genomics, recommending that “healthcare professionals should receive core training in genomic literacy.” Topol goes further, recognising that the effective implementation of genomics into the healthcare system requires a joined-up strategy. It advocates greater attention to genomics, bioinformatics and data science at university level, accredited training, attractive career paths, and a leadership framework across clinical specialities and primary care that encourages best practice. Lexicomp sees itself as part of this process, working to provide everything from pharmacogenomic training tools to timely information that can be embedded into workflows. Our view is that, despite the various challenges outlined above, effective implementation of pharmacogenomics is set to transform patient care, relieve the pressure on clinicians and reduce wastage in the prescribing of drugs. Given that the NHS spends £11 bn a year on drugs, another possible pharmacogenomics dividend will be the freeing up of financial resources to go into other critical areas of frontline healthcare – which, in itself, is a highly desirable outcome.
References
1
https://www.fda.gov/drugs/drug-interactions- labeling/preventable-adverse-drug-reactions- focus-drug-interactions
2
https://upgx.eu/dutch-pharmacogenomics- guidelines-endorsed-in-europe/
3
https://www.23andme.com/?mdc2=true 4
https://academic.oup.com/bmb/article/ 124/1/65/4430783
84 I
WWW.CLINICALSERVICESJOURNAL.COM
5
https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC4064360/
6
https://www.pharmaceutical-journal.com/ news-and-analysis/news/pharmacogenetics- what-are-the-ethical-and-economic- implications/
10001689.article?firstPass=false
7
https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC3175439/
8
https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC4336925/
9
https://jme.bmj.com/content/31/3/144 10
https://www.ft.com/content/46bbaa98-470b- 11e9-a965-23d669740bfb
11
https://topol.hee.nhs.uk/wp-content/uploads/ HEE-Topol-Review-2019.pdf
About the author CSJ
Dr Daniel S. Streetman, PharmD, MS, is the manager of referential content in the Metabolism, Interactions, & Genomics group with Clinical Effectiveness at Wolters Kluwer Health. He completed a research fellowship in clinical pharmacology, with an emphasis in pharmacogenomics, at Bassett Healthcare in Cooperstown, NY, and was a clinical faculty member at the University of Michigan for several years prior to joining Wolters Kluwer. Dr Streetman continues to maintain an academic relationship with several schools, lecturing on pharmacogenomics and other topics.
AUGUST 2019
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