Conflicts of interest in the European Medicines Agency.
On 17 May, the electronic journal EUobserver reported that the European parliament decided almost unanimously not to approve the accounts of the European Medicines Agency (EMA) on grounds of conflict of interest and lack of transparency ( euobserver.com ). In a statement the Parliament expresses its concern "because we can not guarantee the independence of the experts" involved in the evaluation of drugs ( BMJ 2011; 342: d3081 ).
the EMA in the past had been criticized from various quarters, lack of transparency. The French journal Prescrire complained to the Ombudsman in which he complained repeatedly that the EMA had delivered records and other information on drugs with an unfavorable risk-benefit balance, such as rimonabant, telithromycin, memantine, ivabradine, telbivudine , dextropropoxyphene and ketoprofen (Rev Prescrire ).
's reputation for independence and objectivity of the EMA has been questioned after Parliament ordered an investigation into their funding sources, which come in 80% of the pharmaceutical industry. A few days earlier, the EMA had been accused of withholding information about a clinical trial by doctors at the Nordic Cochrane Centre.
In late 2010, the EMA had announced that this year would take effect more stringent rules in their relations with the pharmaceutical industry experts in order to avoid the influence of commercial interests in their decisions (BMJ 2010; 341:855 ).
Conflicts of interest may bias decisions and lead to regulatory approval drugs of doubtful efficacy or toxicity is not known. According to the EUobserver, late withdrawals benfluorex ( Mediator ) and rimonabant have endangered the health of citizens. The lack of transparency of the regulatory agencies and the protection of commercial interests can seriously affect public health.
http://w3.icf.uab.es/notibg/index.php/item/1092
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