The drug contains reboxetine, the controversial antidepressant which is approved in Germany and more than 60 other countries worldwide but has not been cleared by the US Food and Drug Administration (FDA).
The Institute for Quality and Efficacy in Health Care (IQWiG), an independent scientific body focused on health issues, said Pfizer has “refused to provide a complete list of all published and unpublished trials on reboxetine.”
The institute went on to say its own research suggests the agent has been examined in 16 clinical trials, but that in nine of these key information is missing that would enable an evaluation of reboxetine’s performance.
Peter Sawicki, IQWiG director, said: “By concealing study data, the manufacturer is depriving patients and doctors of the opportunity to make an informed decision on different therapy options.”
Pfizer has not yet issued a response to the allegations but, according to a report in Germany’s Die Welt newspaper, claims it “made sufficient data available to [the] IQWiG.”
Sawicki also said that: “deception through concealment is no trivial offence” adding that “in extreme cases, patients may even receive useless treatment if information is incomplete.”
He went on to suggest that “publication bias, the selective release of only data that supports a development candidate, has been a growing problem in the drug industry for the last 20 years.”
The problem is a particular one for anti-depressants where, according to data cited by Sawicki, the benefits of some products may have been exaggerated through selective publication by as much as 30 per cent.
GSK provides all data
IQWiG findings are based on German Federal Joint Committee sponsored research to assess the benefits of three antidepressant agents, reboxetine, mirtazapine and buproprion XL, made by Pfizer, Essex Pharma and GlaxoSmithKline, respectively.
The Institute said that: “It is also possible the not all trials were disclosed,” and that “consequently, the result of the preliminary [efficacy] assessment is to be viewed with reservation.”
In contrast with Pfizer and Essex, UK drugmaker GSK was deemed to have provided all the information requested.