Genome Research and Pharmacovigilance

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Chapter: Pharmacovigilance: Keynote Clinical Lessons from Pharmacovigilance

The large pharmacovigilance databases have been, and will continue to be, remarkably useful in focus-ing on safety issues of individual drugs or families of drugs.


The large pharmacovigilance databases have been, and will continue to be, remarkably useful in focus-ing on safety issues of individual drugs or families of drugs. Nonetheless, in the foreseeable future 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 capabil-ity of detecting drug-induced neoplasias, which could remain undetected in those exposed to long-term ther-apies using other techniques. 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 forma-tion 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 informa-tion 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 to be not only 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 reduc-ing 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 recipi-ents, but are otherwise acceptably safe and of good reputation. Clearly, such a development could only go ahead with the full approval of participating individu-als. Nonetheless, it will also require societal debates if it is to experience seamless progress to its desired end. Genome research not only has significance for the population, but it also has important relevance to indi-vidual participants. The legal implications of acquir-ing knowledge about one’s genetic information cannot be ignored. It is not merely a matter for the individual, but also a matter for the entire family involved. The consequences for individuals seeking life insurance, a mortgage, paying maintenance together with numer-ous other life-decisions with long-term consequences are potentially enormous and must be considered care-fully before we embark on such monitoring projects.

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