PHARMACOGENOMICS
many clinicians, operating flat out and under extreme pressure, don’t understand it or haven’t had time to process it properly. This is where Lexicomp – an internationally respected point-of-care drug information resource from Wolters Kluwer – has an important role to play in accelerating the use of pharmacogenomics, by making the data easier for clinicians to access. We have put a lot of time and resource into building genomics information into our drug reference resources, with the aim of highlighting possibly important drug-gene pairings to clinicians in a clear, concise form, with actionable recommendations. The aim is that this information should be readily available to any professional involved in drug administration, including hospital consultants, first responders, GPs, nurses and pharmacists. Lexicomp activity dovetails with the
important advances being made by clinicians themselves – through a variety of international working groups. The Dutch Pharmacogenetics Working Group (DPWG), for example, has re-energised the sector by creating a robust set of guidelines about how healthcare institutions should use pharmacogenomic information in clinical decisions. In 2018, those guidelines were endorsed by six other European organisations2
Another leader in the effort to
move pharmacogenetic advances into clinical practice, and one that has collaborated with groups like the DPWG, is the Clinical Pharmacogenetics Implementation Consortium (CPIC). Established in 2009, CPIC is led by investigators at St Jude Children’s Research Hospital and Stanford University and was recently awarded $5 million over the next five years by the US National Institutes of Health to continue their efforts. Regulators like the US Food and Drug Administration (FDA) are also encouraging the healthcare sector to embrace genomics. By providing guidance to drug companies on
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.
how to introduce biomarker information to their labelling, they have been helping legitimise the role of pharmacogenomics among the wide clinician community. Away from the professional side of the debate, one big barrier to using genomics is the lack of consumer data available to clinicians. Again, however, there are encouraging signs that this may soon change. With a growing number of moderately- priced testing kits already offering consumers insights into their ancestry and susceptibility to inherited diseases,3
as well as national
initiatives (such as the 100,000 genomes project in the UK and the All of Us program in the US), it’s not a huge stretch to suppose that the mainstream population will increasingly come to see the benefits of having their genomic data applied to medication decisions. Indeed, a recent report from Allied Market Research predicts that the global pharmacogenomics market will register a CAGR (compound annual growth rate) of 8.6% from 2018 to 2025 – rising in value from $5.3 billion in 2017 to $10.2 bn by 2025 (almost double).
Genomics use cases
As referenced at the outset, a major appeal of pharmacogenomics is that it has the potential to impact a wide range of clinical areas. Cardiology, psychology and oncology, for example, are all key areas of investigation – while investigation into the use of steroids has implications for a spectrum of conditions including asthma, eczema, and other
immune-mediated conditions. Particular use cases that have attracted interest recently include the blood-thinning drug warfarin – where it is typical for a process of trial and error to be used until the right dosage is determined. There is now some evidence4
that the availability of
genetic information at the start of treatment makes it possible to fix dosage more rapidly. Some researchers also believe that an improved pharmacogenomics infrastructure could be the key to breaking the logjam in drug development for Alzheimer’s Disease, a condition that is projected to have a global cost to society of $20.8 trillion between 2015-2050.
Also of interest to researchers and clinicians is the use of genomics to individualise drug treatment during pregnancy – an area that encompasses everything from opioid pain management and anti-depressants through to drugs that alleviate nausea and vomiting.5
Cautious optimism
With so much energy and ingenuity already invested in genomics, there is genuine cause for optimism about the ability of this field to move into the mainstream over the next 5-10 years. But if it does, it’s important to recognise that it will bring with it a new set of challenges.
The first, and most obvious, is the sheer scale of the task. At Lexicomp, we are ahead of the curve, having created more than 150 drug-gene monographs covering the most significant and best-described associations, but there is potentially an almost endless number of variations to be explored. When you add to this the fact that there are new drugs and new evidence coming into the healthcare field all the time, it requires constant attention simply to stay on top of the areas we already know. We continue to build out our knowledge of gene-drug pairings, but we are not rushing things. We are taking a measured approach so that we deliver practical and evidence- based information to clinicians.
The challenges are especially acute in the field of oncology, where it is important not just to look at the genomic characteristics of the patient but also at their cancer – since the two can be different. Although oncology is a strategic priority for anyone invested in genomics (because of the rising incidences of cancer expected to accompany longer life expectancies), its use is further complicated by the fact that the characteristics of cancer
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