Politics and its intersection with coverage with evidence development: a qualitative analysis from expert interviews

BACKGROUND: Pressures on health care budgets have led policy makers to discuss how to balance the provision of costly technologies to populations in need and making coverage decisions under uncertainty. Coverage with evidence development (CED) is being employed to meet these challenges. METHODS: Twenty-four interviews were carried out between June 2009 and December 2010 with researchers, decision makers and policy makers from Australia, Canada, United Kingdom and United States. Three phases of coding occurred, the first being manual coding where the interviews were read and notes were taken and nodes were extracted and imputed. NVIVO coding was applied to the interview transcripts, with both broad general searches for word usages and imputed nodes. RESULTS: Four overarching thematic areas emerged out of contextual analysis of the interviews – (1) what constitutes CED; (2) the lack of a systematic approach/governance structure; (3) the role of the pharmaceutical industry and overt political considerations in CED; and (4) alternatives and barriers to CED. We explore these themes and then use concrete examples of CED projects in each of the four countries to illustrate the political issues that our interviewees raised. CONCLUSION: Until the underlying political nature of CED is recognized then fundamental questions about its usefulness and operation will remain unresolved

Réglementation pharmaceutique au Canada et prescription inadéquate de médicaments : le cas des psychotropes dans les années 60 et au début des années 70

Le processus d'approbation des médicaments joue un rôle déterminant dans la façon dont les médicaments sont prescrits au Canada. Cet article examine la nature de la réglementation du processus d'approbation, les décisions qui en découlent, la manière dont ces dernières s'expriment dans la publicité pharmaceutique, et l'impact ultime de ces facteurs sur la prescription des psychotropes en général, et plus particulièrement, des benzodiazépines. Un grand nombre de preuves empiriques portent à croire que les benzodiazépines ont été approuvées à la suite d'essais cliniques inadéquats, entraînant la prescription de ces médicaments pour des états où ils s'avéraient inefficaces et ce, sans tenir compte de certaines mesures de sécurité importantes. Ces déficiences du processus de réglementation ont été amplifiées dans la publicité s'adressant aux médecins, contribuant ainsi à une prescription inappropriée dans quatre cas : la prescription pour des problèmes d'ordre psychosocial, la prescription excessive pour la somatisation, pour les femmes et pour les troubles d'anxiété. Le processus d'approbation présente encore plusieurs lacunes et elles continueront de se manifester par une prescription inadéquate de psychotropes et d'autres médicaments.The outcome of the drug approval process plays a major role in determining how drugs will be prescribed in Canada. The objective of this paper is to examine the nature of the regulatory approval process, its decisions, how these are expressed in pharmaceutical promotion and the ultimate impact of these factors on the prescribing of psychotropic drugs in general and particularly with regard to the benzodiazepines. There is strong circumstantial evidence that the benzodiazepines were approved on the basis of inadequate clinical trials resulting in these drugs being indicated for conditions for which they were not useful and significant safety issues being ignored. These deficiencies in the regulatory process were magnified in the advertising of these products to physicians, thus contributing to inappropriate prescribing in four areas: prescribing for psychosocial problems, overprescribing for somatic complaints, overprescribing to women and overprescribing for anxiety disorders. Problems in the approval process continue to exist and these will manifest themselves in ongoing inappropriate prescribing of psychotropic, and other, medications

All medicines have side effects

status: publishe

Reporting of conflicts of interest from drug trials in Cochrane reviews:cross sectional study

Objectives To investigate the degree to which Cochrane reviews of drug interventions published in 2010 reported conflicts of interest from included trials and, among reviews that reported this information, where it was located in the review documents. Design Cross sectional study. Data sources Cochrane Database of Systematic Reviews. Selection criteria Systematic reviews of drug interventions published in 2010 in the Cochrane Database of Systematic Reviews, with review content classified as up to date in 2008 or later and with results from one or more randomised controlled trials. Results Of 151 included Cochrane reviews, 46 (30%, 95% confidence interval 24% to 38%) reported information on the funding sources of included trials, including 30 (20%, 14% to 27%) that reported information on trial funding for all included trials and 16 (11%, 7% to 17%) that reported for some, but not all, trials. Only 16 of the 151 Cochrane reviews (11%, 7% to 17%) provided any information on trial author-industry financial ties or trial author-industry employment. Information on trial funding and trial author-industry ties was reported in one to seven locations within each review, with no consistent reporting location observed. Conclusions Most Cochrane reviews of drug trials published in 2010 did not provide information on trial funding sources or trial author-industry financial ties or employment. When this information was reported, location of reporting was inconsistent across reviews

Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments

Context Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required to report COIs disclosed in original reports of included RCTs. Objective To investigate whether meta-analyses of pharmacological treatments published in high-impact biomedical journals report COIs disclosed in included RCTs. Data Sources and Study Selection We selected the 3 most recent meta-analyses of patented pharmacological treatments published January 2009 through October 2009 in each general medicine journal with an impact factor of at least 10; in high-impact journals in each of the 5 specialty medicine areas with the greatest 2008 global therapeutic sales (oncology, cardiology, respiratory medicine, endocrinology, and gastroenterology); and in the Cochrane Database of Systematic Reviews. Data Extraction Two investigators independently extracted data on disclosed study funding, author-industry financial ties, and author employment from each meta-analysis, from RCTs included in each meta-analysis, and on whether meta-analyses reported disclosed COIs of included RCTs. Results Of 29 meta-analyses reviewed, which included 509 RCTs, only 2 meta-analyses (7%) reported RCT funding sources; and 0 reported RCT author-industry ties or employment by the pharmaceutical industry. Of 318 meta-analyzed RCTs that reported funding sources, 219 (69%) were industry funded; and 91 of 132 (69%) that reported author financial disclosures had 1 or more authors with pharmaceutical industry financial ties. In 7 of the 29 meta-analyses reviewed, 100% of included RCTs had at least 1 form of disclosed COI (pharmaceutical industry funding, author-industry financial ties, or employment), yet only 1 of these 7 meta-analyses reported RCT funding sources, and 0 reported RCT author-industry ties or employment. Conclusion Among a group of meta-analyses of pharmacological treatments published in high-impact biomedical journals, information concerning primary study funding and author COIs for the included RCTs were only rarely reported. JAMA. 2011;305(10):1008-1017 www.jama.co

Letter to the Editor: Authors' response.

yesWe thank Professors Evans and Wilkins for their interest in our systematic review.(1) We have reached the same conclusion as previous systematic reviews published in 2008(2) and 2014(3) and a review prepared for the New Zealand Ministry for Health in 2009.(4) Even the ‘alternative systematic review’ prepared by Professors Evans and Allen about which we have significant misgivings concludes that ‘larger and rigorous randomised controlled trials of interventions for visual stress are required’.(5)A response to Professors Evans and Wilkins regarding the systematic review: Griffiths PG, Taylor RH, Henderson LM and Barrett BT (2016) The effect of coloured overlays and lenses on reading: a systematic review of the literature. Ophthalmic & Physiological Optics. 36: 519–544

Research and Development of Drugs for Developing Countries Faces Many Barriers

R&D for neglected diseases faces a number of barriers. In order to expand R&D, all of the actors – governments, companies, and NGOs, among others – need to work together on solutions. The limitations of the prize fund model and PPPs need to be addressed.York's Knowledge Mobilization Unit provides services and funding for faculty, graduate students, and community organizations seeking to maximize the impact of academic research and expertise on public policy, social programming, and professional practice. It is supported by SSHRC and CIHR grants, and by the Office of the Vice-President Research & Innovation. [email protected] www.researchimpact.c

Models for financing the regulation of pharmaceutical promotion

Abstract Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models considered here have positive and negative features and none may necessarily be ideal in any particular country. Different countries may choose to utilize a combination of two or more of these models in order to raise sufficient revenue. Financing of regulation of drug promotion should more than pay for itself through the prevention of unnecessary drug costs and the avoidance of adverse health effects due to inappropriate prescribing. However, it involves an initial outlay of money that is currently not being spent and many national governments, in both rich and poor countries, are unwilling to incur extra costs.</p