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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The hexamethonium asthma study and the death of a normal volunteer in research (Papers: Julian Savulescu & Merle Spriggs | July 2001)0

Posted by Admin in on May 20, 2017

On July 19, after investigating the death of a previously healthy volunteer, the United States Office for Human Research Protections (OHRP) suspended nearly all federally funded medical research involving human subjects at Johns Hopkins University. The death has been described as “particularly disturbing” because 24 year old Ellen Roche was a healthy volunteer who had nothing to gain by taking part in the study.1 Her death has revived debate about the adequacy of oversight of medical research that followed the death of 18 year old Jesse Gelsinger who volunteered for a gene therapy experiment.

Savulescu J, Spriggs M (2002) The hexamethonium asthma study and the death of a normal volunteer in research. Journal of Medical Ethics. 28:3-4.
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Also read
2001 New York Times story

Friday afternoon’s funny – Adverse event reporting0

Posted by Admin in on November 18, 2016


Cartoon by Don Mayne

Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review (Papers: Su Golder, et al 2016)0

Posted by Admin in on October 20, 2016


We performed a systematic review to assess whether we can quantify the underreporting of adverse events (AEs) in the published medical literature documenting the results of clinical trials as compared with other nonpublished sources, and whether we can measure the impact this underreporting has on systematic reviews of adverse events.

Methods and Findings
Studies were identified from 15 databases (including MEDLINE and Embase) and by handsearching, reference checking, internet searches, and contacting experts. The last database searches were conducted in July 2016. There were 28 methodological evaluations that met the inclusion criteria. Of these, 9 studies compared the proportion of trials reporting adverse events by publication status.

The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies.

A total of 11 studies compared the numbers of adverse events in matched published and unpublished documents. The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Within these 11 studies, 24 comparisons of named adverse events such as death, suicide, or respiratory adverse events were undertaken. In 18 of the 24 comparisons, the number of named adverse events was higher in unpublished than published documents. Additionally, 2 other studies demonstrated that there are substantially more types of adverse events reported in matched unpublished than published documents. There were 20 meta-analyses that reported the odds ratios (ORs) and/or risk ratios (RRs) for adverse events with and without unpublished data. Inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in 15 of the 20 pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases.

The main limitations of this review are that the included case examples represent only a small number amongst thousands of meta-analyses of harms and that the included studies may suffer from publication bias, whereby substantial differences between published and unpublished data are more likely to be published.

There is strong evidence that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. The inclusion of unpublished data can also reduce the imprecision of pooled effect estimates during meta-analysis of adverse events.

Golder S, Loke YK, Wright K, Norman G (2016) Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review. PLoS Med 13(9): e1002127. doi: 10.1371/journal.pmed.1002127
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Indian Journal of Medical Ethics (IJME)0

Posted by Admin in on September 11, 2016

ijme“In 1992, eight doctors known for their eminence in ethical practice and concern for the public health system established a panel on the platform of Forum for Medical Ethics (FME) and contested the Maharashtra Medical Council (MMC) elections. By sending out a letter to all doctors in Maharashtra and by using the media for creating public awareness on the role and responsibilities of the Medical Councils, the FME strove to bring the implementation of medical ethics to the centre of the debate in the election. The FME ensured that votes for the members of its panel were voluntarily sent through mail by each voter on his/her own in the postal ballot system used for the elections at that time. The group also witnessed massive rigging of the elections by the candidate-doctors supported by money power and politics. The electoral malpractices were documented in detail by the group, and presented to the Mumbai High Court in a PIL and also communicated widely through the first newsletter, entitled “Medical Ethics”, published in August 1993.

Medical Ethics found wider support from the profession and the public, and was brought out every three months and gradually expanded its scope. When it applied for registration as a journal with the Registrar of Newspapers, New Delhi, it was provided a new title, and so from January 1996, it was brought out as Issues in Medical Ethics. Later, when the Registrar of Newspapers accepted our application for the change in name, the journal started coming out as Indian Journal of Medical Ethics from January 2004.”

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