DOI: 10.5061/dryad.8pk0p2nkq
title: The clinical impact of high-profile animal-based research reported in the UK national press: a detailed discussion of articles from 1995, and full search results from the Nexis database

description: Objectives: We evaluated animal-based biomedical ‘breakthroughs’ reported
 in the UK national press in 1995 (25 years prior to the conclusion of this
 study). Based on evidence of over-speculative reporting of biomedical
 research in other areas (e.g. press releases and scientific papers), we
 specifically examined animal research in the media, asking, “In a given
 year, what proportion of animal research ‘breakthroughs’ published in the
 UK national press had translated, more than 20 years later, to approved
 interventions?” Methods: We searched the Nexis media database
 (LexisNexis.com) for animal-based biomedical reports in the UK national
 press. The only restrictions were that the intervention should be
 specific, such as a named drug, gene, biomedical pathway, to facilitate
 follow-up, and that there should be claims of some clinical
 promise.  Main Outcome Measures: Were any interventions approved
 for human use? If so, when and by which agency? If not, why, and how far
 did development proceed? Were any other, directly related interventions
 approved? Did any of the reports over-state human relevance? Results:
 Over-speculation and exaggeration of human relevance was evident in all
 the articles examined. Of 27 unique published ‘breakthroughs’, only one
 had clearly resulted in human benefit. Twenty were classified as failures,
 three were inconclusive, and three were partially successful.
 Conclusions: The results of animal-based pre-clinical research studies are
 commonly over-stated in media reports, to prematurely imply often-imminent
 ‘breakthroughs’ relevant to human medicine.
description: The “Nexis” database is an archive of more than 40,000 information sources of various types, including news content, provided by the international company, LexisNexis (lexisnexis.com). Media sources were selected to include ‘UK national newspapers’, in the calendar year 1995. The search strategy involved selecting the ‘Medical research’ index term, then adding the following animal terms to identify news items based on animal research: ‘animal OR mouse OR mice OR rodent OR rat OR dog OR cat OR monkey OR primate OR guinea pig OR rabbit’. Articles that did not describe a clear, direct clinical promise, or that described a non-clinical application (e.g. agricultural or veterinary), or that described <i>only</i>mechanisms of action, pathophysiology, or diagnosis, or in which the intervention was not of a specific named procedure or compound, or was not speculated to be associated with a specific gene/molecule/pathway, were excluded. For each report, the associated academic publication(s) were obtained, where available, and as much of the following data that were available were extracted: title, news media source, publishing journal, date of publication, author name(s), PubMed ID and links, animal species and numbers used, intervention, preventive/therapeutic in nature, expected clinical benefit and years to expected benefit, relevant text and summary of findings, disease in question, institution, funding body, harms to animals, any salient quotes from authors, any obvious related material, etc. To investigate whether clinical benefit transpired within 20-plus years, the following websites and sources were consulted: PubMed, the European Medicines Agency (EMA), the UK Medicines and Healthcare Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), clinicaltrials.gov, Medscape.com, the National Institute for Health and Care Excellence (NICE), the British National Formulary (BNF), Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and the US National Library of Medicine’s TOXNET. Data obtained from thorough searches of these sources were collated, and used to determine the outcome of each ‘breakthrough’ with regard to any further studies that were conducted; whether these were human, animal or both; if clinical trials were conducted, and what the results of these were with respect to efficacy and adverse drug reactions (ADRs); if the drug/intervention reached the market, and if so, if it had been relabelled or recalled. Based on the above, a decision was made, in consultation with colleagues, about whether the 1995 media report had been accurate in reporting the research as a ‘breakthrough’. For clarity: if the intervention in question had not been approved at the time of writing, more than 20 years after the media report, it was classified as ‘Failed’. Some were classified as a ‘Partial success’, if, for example: use was restricted clinically and/or geographically; any use was specific to particular, rather than general, circumstances (i.e. a narrower use than had been claimed); an approved therapy was of questionable efficacy; evidence from other, non-animal research data (including human data) suggested the animal data were not crucial to the ‘breakthrough’; there was an indirect relation between the ‘breakthrough’ and the successful intervention; there was questionable clinical relevance of the animal data, and so on.