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Drug regulatory bodies:
experts under the influence

Disclosure of their experts' links to pharmaceutical companies does not ensure that drug regulatory agencies' decisions are impartial.

The links between drug regulatory agency experts and pharmaceutical companies are not without consequences.

After Roche obtained a marketing authorisation for erlotinib to be used in the treatment of cancers, the European Medicines Agency (EMEA) rejected the company's application for the licence to be extended to advanced or metastatic cancers of the pancreas. EMEA’s licensing committee had noted that erlotinib’s adverse effects in these situations are not counterbalanced by any tangible benefits.

Roche challenged the decision and EMEA called on four outside experts to review the application. The experts returned a favourable opinion and erlotinib was granted a marketing authorisation for use in the treatment of metastatic cancers of the pancreas.

Although the application under consideration was exactly the same, greater emphasis was placed upon the evidence in the company's favour. Prescrire asked the EMEA whether these four outside experts had any interests linking them with pharmaceutical companies. It emerged that three out of the four experts had ties with Roche.

Society’s demand for transparency has led to legislation which now forces drug regulatory agencies to disclose any interests their employees and the outside experts they consult may have.

Clearly, this transparency is not sufficient to guarantee agencies’ independence from drug companies.

©Prescrire November 2007

Sources: "Experts sous influence" Rev Prescrire 2007 ; 27 (289) : 804.
"Précisions et corrections" Rev Prescrire 2008 ; 28 (293) : II.

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