IQWiG calls for EU trial disclosure laws, says Pfizer delayed report
IQWiG, an independent German healthcare watchdog, alleged that Pfizer failed to disclose data from all trials of its reboxetine-based antidepressant Erdonax until it came under public pressure earlier this year, and that this delayed the publication of its report.
Director Peter Sawicki said that, in addition to impacting his group’s work, selective publication of data also “[deprives] patients and doctors of the opportunity to make an informed decision on different therapy options.
“By concealing data, manufacturers are also breaking agreements that were made with study participants, who put themselves at risk by taking part in experiments both voluntarily and altruistically.”
Sawicki called for regulators in the European Union (EU) to implement comparable registration and disclosure rules to those that have operated in the US since 2008, adding that “it is essential that such an obligation must also apply retrospectively to drugs already approved.
Voluntary disclosure ineffective
Sawicki also said the current system of voluntary disclosure covered by IQWiG’s 2005 agreement with a number of pharmaceutical industry associations is not working.
“Companies have repeatedly refused to provide the Institute with study documents required for the benefit assessment of drugs. Frequently, clinical trial registries, which have been set up in recent years, do not contain these data either.”
Sawicki added that: “IQWiG's experience has shown that the existing countermeasures, which are primarily based on voluntary solutions in Germany and Europe, are inadequate.
“It is not known when and how statutory regulations aimed at solving the problem will actually take effect. IQWiG is therefore calling for an EU-wide legal obligation, bound by tight deadlines, to publish the results of clinical trials.”
Pfizer response
In a statement issued yesterday Pfizer, which has consistently denied the IQWiG's allegations, said: "[it] had provided the Institute with relevant data for the assessment of the benefits of Reboxetin. Pfizer was confident these data were sufficient in order to conduct a thorough benefit assessment.
"However, the IQWiG concluded at the time that further data were required in order to be able to make a final assessment of the benefits of the therapy. Pfizer is committed to transparency and openness.
"For this reason, the company consequently provided the IQWiG with each and every study on Reboxetin available and known to us. However, Pfizer reiterates that we have not kept data from the IQWiG previously. All key information of those additional studies as requested by the IQWiG have already been available from previously published sources."
