International Journal of Risk & Safety in Medicine - Volume 23, issue 2
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: At the time of the outbreak of the pandemic of New Influenza A (H1N1) pandemic influenza vaccines became available via an accelerated registration procedure. In 2005 large stocks of the neuraminidase inhibitor oseltamivir were built up in the Netherlands and other western countries. There was considerable doubt about the efficacy of this medicine. Initially reported positive effects of the drug were largely based on unpublished research, which was sponsored by the manufacturer and was partially written by ghostwriters. There now have been reports of rare and serious side effects. The first reports on the severity of the pandemic in Australia…and New Zealand indicated a mild course.
Abstract: The first reports of the New Influenza A (H1N1) spoke of a markedly increased morbidity and mortality. Later it turned out that this flu was a very mild flu. Gradually the role of the WHO was questioned. The definition of a pandemic flu had been changed and there rose doubts about the independency of the experts advising the WHO. It showed that some of these experts had a conflict of interest with the pharmaceutical industry, especially with those producing vaccines and neuraminidase inhibitors. As of june 2010 the WHO declared the outbreak to be a pandemic. This provided the momentum…to produce vaccines. At the outbreak of the pandemic in the northern hemisphere, there was sufficient evidence that the pandemic would not be so serious, that a single vaccination was sufficient, that there were strong doubts about the efficacy of oseltamivir and that the drug, although rarely, could have serious side effects. With the stockpiling of neuraminidase inhibitors and with the recommendation of the vaccination political decisions were involved. These decisions should be driven and supported by independent scientific advisory bodies with no room for even the semblance of conflicts of interest. Stronger measures to limit the impact of experts with conflicts of interest on the development of, among others, guidelines are necessary.
Keywords: New Influenza A (H1N1), swine flu, pandemic, seasonal influenza, neuraminidase inhibitors, oseltamivir, zanamivir, pandemic influenza vaccines
Abstract: In November 2009, a vaccination campaign against Influenza A (H1N1) was started in the Netherlands. The accelerated registration procedure of the vaccines used in this campaign and the use of these vaccines on a large scale indicated a need for real-time safety monitoring. This article looks at the way in which the safety monitoring of the pandemic influenza vaccines was organized in the Netherlands and it gives an overview of the main findings with respect to the two pandemic influenza vaccines, Focetria and Pandemrix, used in the Netherlands. Close monitoring, an efficient processing and analyzing the reports resulted in a…close and real-time monitoring of the safety of the vaccines. From 1 November 2009 until 1 March 2010, 7534 reports concerning one or more events possibly related to the administration of both vaccines were received. 2788 of the reports related to Focetria and 4746 of the reports related to Pandemrix. No signals of possible batch-related problems were detected for either vaccine. The profile of the reported adverse events is comparable with the information provided in the Summary of Product Characteristics (SPC). Differences in reported events between both vaccines may be caused by bias and confounding due to the different populations for which these vaccines have been used.
Keywords: Swine flu, H1N1, new influenza A (H1N1), side effects
Abstract: A wide range of neurological complications have been reported via the medical literature and the VAERS system after vaccination with recombinant outer surface protein A (OspA) of Borrelia. To explore this issue, 24 patients reporting neurological adverse events (AE) after vaccination with Lymerix, out of a group of 94 patients reporting adverse events after Lymerix vaccination, were examined for causation. Five reports of cerebral ischemia, two transient Ischemic attacks, five demyelinating events, two optic neuritis, two reports of transverse myelitis, and one non-specific demyelinating condition are evaluated in this paper. Caution is raised on not actively looking for neurologic AE,…and for not considering causation when the incidence rate is too low to raise a calculable difference to natural occurence.
Keywords: OspA, Lyme disease vaccine, outer surface protein A, neurologic adverse events
Abstract: This Perspective discusses the following study published in PLoS Medicine: Skowronski DM, De Serres G, Crocroft N, Janjua NZ, Boulianne N, et al. (2010) Association between the 2008–09 Seasonal Influenza Vaccine and Pandemic H1N1 Illness during Spring–Summer 2009 : Four Observational Studies from Canada. PLoS Med 7(4): e1000258. doi:10.1371/journal.pmed.1000258. In three case-control studies and a household transmission cohort, Danuta Skowronski and colleagues find an association between prior seasonal flu vaccination and increased risk of 2009 pandemic H1N1 flu.
Abstract: Objective: A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil® and the RIVM report on Cervarix® . Method: all AEFI from the three sources were recalculated to a percentage of all AEFI reported for each of the two vaccines. And the safety profile was compared to the safety data in the SPC. Results: Comparison of relative AEFI reporting proportions in the global VigiBase database with VAERS for Gardasil® and with RIVM for Cervarix® shows a safety profile in…VigiBase similar to the result of PMS on a national level in 2 countries. Conclusion: The post licensure safety profile of both vaccines is consistent with the data in the SPC of these vaccines.
Abstract: Brief reports are presented on Swissmedic's experiences with PaniFlow™, a tool to monitor Adverse Events Following Immunization (AEFI) of pandemic influenza (H1N1) 2009 vaccines and UMC's updates on AEFI of these vaccines; on WHO's Global Network for Post-marketing Surveillance of Prequalified Vaccines and India joining the network; the June 2010 meeting of the Global Advisory Committee on Vaccine Safety.
Abstract: Objective: This study aimed to investigate the role of genetic biomarkers in assessing risk for the eventual development of type 2 diabetes mellitus (T2DM). Methods: Three Maltese women with a history of previous severe GDM and with apparent similar clinical risk factors underwent anthropomorphic and metabolic reassessment 4–7 years post-partum. They were further genotyped for four specific genetic single nucleotide polymorphisms (SNPs) using the qPCR technique for the alleles of SLC2A2 (rs5393A/C), FTO (rs9939609A/T), PCK (rs2071023C/G) and CDKAL1 (rs10946398A/C). Results: While the previous obstetric history of all the cases was similar, the biological status was characterized by an increasing degree…of obesity correlating to increasing severity of current carbohydrate intolerance. Genotyping showed that all the tested SNPs were homozygous mutant in the T2DM woman and heterozygous in the impaired glucose tolerance woman. The woman with normal glucose tolerance was shown to be wild type for SLC2A2 (rs5393A/C). Conclusions: There appeared to be an interrelationship between eventual severity of carbohydrate metabolism abnormalities and the genetic allele status. It would appear that the specific allele-scoring can be used to identify further the potential risk of developing T2DM.
Keywords: Type 2 diabetes mellitus, risk factors, previous gestational diabetes mellitus, single nucleotide polymorphism, specific allele-scoring
Abstract: Background: Prescribing of selective serotonin reuptake inhibitors (SSRIs) has increased dramatically. Objective: To compare the sales of benzodiazepines and SSRIs within the primary care sector in Denmark and relate changes in usage to number of indications and products on the market. Methods: We used data from various sources to establish the sales curves of psychotropic drugs in the period 1970 to 2007, based on the Anatomic Therapeutic Classification system and Defined Daily Doses. Results: Fluctuations in sales of psychotropic drugs that cannot be explained by disease prevalence were caused by changes in sales of the benzodiazepines and SSRIs. We found…a decline in the sales of benzodiazepines after a peak in 1986, likely due to the recognition that they cause dependence. From a low level in 1992, we found that the sales of SSRIs increased almost linearly by a factor of 18, up to 44 DDD per 1000 inhabitants, which was closely related to the number of products on the market that increased by a factor of 16. Conclusions: Sales of antidepressant drugs are mainly determined by market availability of products indicating that marketing pressures are playing an important role. Thus the current level of use of SSRIs may not be evidence-based, which is supported by studies showing that the effect of SSRIs has been overestimated.