Abstract
Pharmacovigilance has not achieved the public profile as a health priority or the impact on patients’ lives that we might have hoped; the vision of comprehensive patient safety, though much stronger since thalidomide, is still far from being realised. Great strides have been made in some regions and institutions, but the overall picture is still deeply disturbing: harm to patients is widespread [1].
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Notes
- 1.
See Chapter XX, Lost in Regulation, for much more on this topic.
- 2.
GSK’s Study 329 is amongst the most notorious examples of negative clinical trial data being corruptly represented as positive and used as the basis for massive and profitable marketing of an ineffective and dangerous drug (Paxil/paroxetine). A recent reanalysis of the original data has revealed the extent of the fraudulent claims (see: http://www.bmj.com/content/351/bmj.h4320). Johnson and Johnson’s Risperdal/risperidone has also been subject to massive controversy and punitive litigation as a result of evidence of underestimated and undeclared serious side effects (see, e.g. http://www.drugdangers.com/risperdal/).
- 3.
Turing’s decision, in September 2015, to increase the price of Daraprim by around 5,000 % was a controversial and emblematic example of the drive for profit irrespective of its impact on patients or health funding.
- 4.
I am going to write some very critical and negative things about the practice of pharmacovigilance. The global picture is not, of course, one of unmitigated blackness and failure, but I am not going to qualify my remarks at every stage with mentioning the achievers and the exceptions; where the hat fits, it is probably being worn. You, my reader, must judge if any aspect of what I say applies to your own circumstances in your country or whether you can pat yourself on the back for having avoided all the old pitfalls and shown the way to new and better things. The opinions are based on reading, observation and experience in many parts of their world, including Europe and far beyond.
- 5.
The Thai Health Promotion Foundation, for example, has been using original and creative videos for some years. One of their most famous is at https://www.youtube.com/watch?v=aHrdy6qcumg
- 6.
The US Centers for Disease Control and Prevention (CDC; www.cdc.gov) appears to be an agency in tune with the modern age in the variety, ingenuity and reach of its communications; Medindia (www.medinida.net) is a modern site for patients, similar to other excellent official and voluntary resources in a few other countries (e.g. www.patient.info in the UK). But these operations are not primarily concerned with regulation or pharmacovigilance.
- 7.
While WHO achieves many great things, especially through its small, decentralised, agile units in the field, its intrinsic weakness as a lumbering, centralised bureaucracy was starkly revealed in the disastrous handling of the early days of the 2015 Ebola epidemic. It was a failure that contributed to the ultimate death toll of more than 11,000 people.
- 8.
Henry Gantt developed his chart in the decade before the First World War, and early applications included US military planning.
- 9.
‘Waterfall’ management is the style typical of traditional hierarchical power structures where decisions are made at the top and are cascaded (maybe dumped) onto those below, whose duty is not to reason why but to get the specified job done.
- 10.
Terms like ‘sprint’ and ‘scrum’ come from this field.
- 11.
So central, by the way, to development aid projects; so alien to the cultures of many developing countries in which they take place.
- 12.
David Furniss (Will 2014 be the year telehealth comes of age?, The Guardian, 21 January 2014) wrote: ‘I predict that 2014 will be the year of the agile worker – this means giving staff access to data and information on the move, helping them spend more time with patients and less time travelling or in the office’.
- 13.
Drug scares and crises do bring the operation of regulatory and PV bureaucracies into the glare of publicity. Such incidents are often the result of deficiencies in courage, agility and communications, not of science or intelligence.
- 14.
Underreporting is not just about numbers, of course, but also about relevance and importance. Poor quality reports are as serious an issue as low numbers.
- 15.
The NHS Wales 1000 Lives project runs an attractive campaign called Champions for Health, originally inspired by the 2012 Olympics. It doesn’t have many of the real characteristics of international sport, but it has borrowed some of the colour and energy of sporting culture (http://www.1000livesplus.wales.nhs.uk/c4h).
- 16.
A further threat to their success is the complacency and arrogance of great companies and bureaucracies. The most remarkable example of that in recent years has been Volkswagen, which abandoned core business ethics and forgot that they were accountable, and would be held accountable, to users and authorities round the world. One account of the disaster here: http://www.telegraph.co.uk/finance/newsbysector/industry/11881819/Volkswagen-live-VW-issues-profit-warning-sets-aside-6.5bn.html
- 17.
Govindarajan V. Telemedicine can cut health care costs by 90 %. Harvard Business Review, April 23, 2012.
- 18.
‘Of the several hundred cases that have already gone through this process, approximately 80 % of the patients we’ve contacted have reported their top diagnostic or solution suggestions to be accurate. In addition, over 50 % of our patients report that their CrowdMed results brought them closer to a correct diagnosis or cure – and these patients had already seen 8 doctors, been sick for 8 years, and incurred over $55,000 in medical expenses to date, on average’ (https://www.crowdmed.com/faqs).
- 19.
See Gray et al. [27].
- 20.
‘How do you manage professionals? You don’t!’; in, K. Monsen and J. de Blok, ‘Buurtzorg Nederland’, American Journal of Nursing, Aug. 2013 113(8):55–59.
- 21.
For example, Abubakar et al. [28].
- 22.
If, as IKEA’s head of sustainability recently asserted, the appetite of Western consumers for home furnishings has reached its peak, the company has to envisage a radical new strategy to maintain its dominant position. See Guardian Live Event, 14 Jan 2016, http://www.theguardian.com/membership/audio/2016/jan/14/is-business-action-on-climate-change-believable-guardian-live-event
- 23.
‘For instance, a large advertising agency awards a quarterly Heroic Failure trophy to recognize clever, unproven ideas that may not work out in practice but nevertheless demonstrate creative risk taking. And an online payroll provider offers $400 to the winner of its Best New Mistake Award, which goes to an employee who made a mistake but learned from it—and, in doing so, helped other employees avoid similar mistakes. The idea behind both awards is to support creativity by encouraging openness about errors and rewarding those who genuinely learn from their failures’ (Accenture, see credit in boxed text, p. XX).
- 24.
From very small beginnings, the annual number of reports has been on a rising graph, with great increases in recent years. The figures quoted do not reflect this improving trend over time, but the aggregate historic averages are correct. [The number of reports in VigiBase will be substantially higher by the time you read this.]
- 25.
The WHO’s extant guidelines for setting up a PV centre, published in 2000, have, as item number two in the list of activities: ‘Design a reporting form … and start collecting data by distributing it to hospital departments, family practitioners, etc.’ There is no commentary or suggestion that there might be other ways of doing the job (WHO: Safety Monitoring of Medicinal Products 2000).
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Hugman, B. (2017). Shaking Up Culture and Communication in PV [V6]. In: Edwards, I., Lindquist, M. (eds) Pharmacovigilance. Adis, Cham. https://doi.org/10.1007/978-3-319-40400-4_9
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