Prescrire filed a complaint on 30 August 2010 with the EU Ombudsman, P. Nikiforos Diamandouros, citing EMA’s repeated refusals to supply documents and information, in particular on drugs with an unfavourable risk-benefit balance. Or because the documents provided were largely censored, and therefore unusable. The reason given by EMA for these refusals was often the protection of trade secrets.
Prescrire, an independent journal, analyses clinical data on drugs in order to provide physicians and pharmacists with information for rational subscribing, free from any commercial influences.
These data come mainly from clinical trials. The results of some of these trials are published in international journals. Others are not published, but are none the less supplied to the agencies in charge of granting marketing authorisations and used in the drug’s evaluation, in other words to assess its risk-benefit balance for the patients who take it.
Other documents, established after drugs are on the market, also contain essential information concerning the risks once the drugs have been used by a large number of patients. These "PSURs" (Periodic Safety Updated Reports) reflect the adverse effects reported to the regulatory bodies in charge of collecting pharmacovigilance reports.
Several widely prescribed drugs have been withdrawn from the market recently due to the serious, and sometimes fatal, adverse effects to which many patients have been subjected, for example: the anti-inflammatory rofecoxib (ex-Vioxx°); weight-loss drugs rimonabant (ex-Acomplia°) and benfluorex (ex-Mediator°), cholesterol-lowering drug cerivastatin (ex-Staltor°), etc. Yet the existence of these risks could have been found in the results of the clinical trials, or in the PSURs.
Prescrire’s complaint concerns 5 particularly unacceptable refusals by the Agency:
- refusal to send a Reference Member State assessment report on rimonabant, a dangerous anti-obesity drug that was withdrawn for safety issues from the European market some months after Prescrire’s request
- refusal to provide Prescrire with any Periodic Safety Updated Reports (PSURs)
- EMA refusal to provide Prescrire with mock-up packaging
- refusal to give access to clinical data on the dextropropoxyphene + paracetamol combination.
- EMA's refusal to provide Prescrire with the assessment report established by the member state medicines agency designated by the European authorities to determine the safety of topical ketoprofen.
©Prescrire 1 September 2010
References :
1- Prescrire Editorial Staff "Legal obligations for transparency at the European Medicines Agency: Prescrire's assessment over four years" Prescrire Int 2009; 18 (103): 228-231. (Pdf, free).
2- Prescrire to EMA - Excessive secrecy beyond the law.pdf
3- EMA Letters to Prescrire rimonabant 7 October 2008 + 16 October 2008 + 30 October 2008.pdf
4- Acomplia Swedish report sent by EMA.pdf
5- EMA Letter to Prescrire telithromycin 14 January 2009.pdf
6- EMA Letters to Prescrire memantine 12 February 2009 + 6 March 2009.pdf
7- EMA Letter to Prescrire ivabradine 30 June 2009.pdf
8- EMA Letter to Prescrire telbivudine mock-ups 5 June 2009 + 2 July 2009.pdf
9- EMA Letter to Prescrire Dextropropoxyphene 8 May 2010.pdf
10- EMA Letters to Prescrire ketoprofen 17 March 2010 + 10 May 2010.pdf
