Conflicts of interest and the (in)dependence of experts advising government on immunization policies

Bélisle-Pipon, Jean-Christophe; Ringuette, Louise; Cloutier, Anne-Isabelle; Doudenkova, Victoria; Williams‐Jones, Bryn

doi:10.1016/j.vaccine.2018.10.058

Cited by 5 publications

(1 citation statement)

References 19 publications

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“…However, agency personnel are themselves independent experts, or should be (Ferrera et al 2014;Freedman 1976), and convening expert panels imposes costs in terms of both time and money, partially undermining the goal of an expedited review before it has begun. Concerns exist about the extent to which regulatory agencies have been captured by the industry, such as by the payment of industry user fees (Darrow et al 2017), but members of expert panels can (and frequently do) have similar or more severe conflicts of interest (Bélisle-Pipon et al 2018;Hayes and Prasad 2018). Regardless of the identity of the expert, the drug sponsor will be providing the data on which the expert' s decision or recommendation is based.…”

Section: Lessons From Lexchin' S Workmentioning

confidence: 99%

Commentary: Expedited Regulatory Review of Low-Value Drugs

Darrow¹,

Beall²

2020

hcpol

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Lexchin has criticized Health Canada' s recently published draft guidance on accelerated drug review, expressing concern over agency conflicts of interest and observing that priority review and notice of compliance with conditions correlate poorly with therapeutic benefit. Although agency operations may be imperfect, perhaps the most important finding of Lexchin' s research is that only 11% of newly approved drugs provide meaningful benefit over standard treatments. To improve the expedited review process in light of these findings, we suggest eliminating user fees and fully funding the review process with public monies, reserving the use of expedited approval pathways for when preliminary measures of benefit are so large that traditional approval thresholds can be met earlier in the clinical trial process, improving labelling to quantitatively communicate drug benefits and risks, and avoiding the use of titles such as "priority" review, which could imply a magnitude of clinical superiority that has not been established. RésuméLexchin a critiqué la version provisoire des lignes directrices de Santé Canada sur l' examen accéléré des médicaments, publiée récemment, en se disant préoccupé par les conflits d'intérêt de l'institution et en observant qu'il y a une faible corrélation entre, d' une part,

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Section: Lessons From Lexchin' S Workmentioning

confidence: 99%