Genome Research And Pharmacovigilance

The large pharmacovigilance databases have been and, in my view, will continue to be remarkably useful in focusing on safety issues of individual drugs or family of drugs. Nonetheless, in the twenty-first century this will not be sufficient on its own to justify their expansion and increasingly widespread use. Some have been in existence for over 10 years and hence have a significant risk of detecting any drug-induced neoplasias, which could be lurking in the undergrowth, for those exposed to long-term therapies. The only significant area in which this seems to have occurred to date, apart from very rare tumours in users of regular hormone therapies, is with the long-term immunosuppressed patients. This is good news insofar as it goes. The power of the databases to recognise tumour formation in long-term recipients of individual medicines or classes of medicines would be greatly enhanced were they to include a sizeable sub-population for whom genetic footprints were known. Such an advance is now coming within our grasp. Whilst a number of groups are looking at setting up new surveillance systems to include genetic profiles in the information they capture, the real prizes are likely to be won by grafting this additional information on to existing large data sets in which long-term studies have already been undertaken. The pay-off from this research is likely not only to be a greater understanding of the links between the genome and adverse drug events, but also a better understanding of tumour genesis in the population at large. Were these issues to be clarified, it is theoretically possible that a proportion of susceptible individuals could be advised to avoid certain drugs before they have ever been exposed to them. One suspects this will take several decades to achieve, but it could have the overall benefit of reducing individual risks of adverse events and prolonging the useful life of those drugs that have problems in a specific small sub-set of the population of recipients, but are otherwise acceptably safe and of good reputation. Clearly, such a development could only go ahead with the full approval of participating individuals. Nonetheless, it will also require societal debates if it is to experience seamless progress to its desired end. Genome research has significance for the population, but it also has important relevance to individual participants. The legal implications of acquiring knowledge about one's genetic fingerprints cannot be ignored. It is not merely a matter for the individual immediately involved, but also a matter for the entire family involved. The consequences for individuals seeking life insurance, a mortgage, paying maintenance, etc. are potentially large and must be considered carefully before we embark on such monitoring projects.

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