Page 407 - شرور شركات الأدوية

‫ﻣﻼﺣﻈﺎت‬

(68) Strech D, Littmann J. Lack of proportionality. Seven specifica-
tions of public interest that override post-approval commercial interests
on limited access to clinical data. Trials. 2012 Jul 2;13(1):100.

(69) Lenzer J, Brownlee S. Antidepressants: an untold story? BMJ
2008;336:532–4.

(70) Wood AJ. Progress and deficiencies in the registration of clinical
trials. N Engl J Med. 2009;360(8):824–830.

(71) O’Connor AB. The need for improved access to FDA reviews.
JAMA: The Journal of the American Medical Association. 2009;302(2):191.

(72) http://www.prescrire.org/editoriaux/EDI33693.pdf.
(73) Decision of the European Ombudsman closing his inquiry into
complaint 2560/2007/BEH against the European Medicines Agency. No-
vember 2010. http://www.ombudsman.europa.eu/cases/decision.faces/
en/5459/html.bookmark.
(74) UK drug regulator destroys all the evidence after 15 years/BMI
[Internet]. Available from http://www.bmj.com/rapid-response/2011/
11/03/uk-drug-regulator-destroys-all-evidence-after-15-years.
(75) You might be unsurprised to hear that no large drug company has
ever been prosecuted under the safety monitoring regulations in the UK.
(76) This story is spread over various publications by the Cochrane
team, and the account here is taken from their work, published responses
from Roche, and discussions with the Cochrane team. The best place
to get the early half of this story is this paper: Doshi P. Neuraminidase
inhibitors—the story behind the Cochrane review. BMJ. 2009;339. And for
the second half, I recommend this open-access paper: Doshi P, Jeffer-
son T, Del Mar C (2012) The Imperative to Share Clinical Study Reports:
Recommendations from the Tamiflu Experience. PLoS Med 9(4): e1001201.
doi:10.1371/journal.pmed.1001201 http://bit.ly/HIbwqO.

407