German regulators aren't too happy with Pfizer. The country's Institute for Quality and Efficacy in Health Care (IQWiG) is accusing the drugmaker of deliberately withholding data on its antidepressant reboxetine (Edronax). IQWiG--which chooses the drugs German government will foot the bill for--says it has found evidence of 16 clinical trials of the drug, but key information from nine of those studies was allegedly withheld by Pfizer. The agency also says that Pfizer won't give it a list of all published and unpublished reboxetine reesearch. The company, however, told a German newspaper that it has given "sufficient data" to IQWiG.
In criticizing Pfizer, IQWiG director Peter Sawicki raised the spectre of publication bias, citing research showing that bias affects antidepressants in particular. You may recall the brouhaha over a U.K. study that concluded many antidepressants would be deemed ineffective if all clinical trials had been published. "Deception through concealment is no trivial offence," says Sawicki in a statement. "In extreme cases, patients may even receive useless treatments if information is incomplete." The agency's decision on reboxetine: No proof of benefit.
Sawicki was so irritated by Pfizer's incomplete data--and similarly incomplete data on another antidepressant from Essex Pharma--that he's calling for the E.U. to require all drugmakers to disclose info on clinical trials. That includes all clinical trials and past studies. Currently, the industry has a voluntary disclosure policy, but companies haven't been following it, the IQWiG statement says. Even clinical trial registries are incomplete, the agency contends.
As BNet Pharma and In Vivo both note, only GlaxoSmithKline has been completely forthcoming with data on its antidepressant Wellbutrin XL. IQWiG commended GSK for handing over all the clinical trial info and gave the drug its blessing. Holding back data obviously didn't help reboxetine clear the German review, so it's not as if Pfizer helped itself by doing so. And by serving as the proverbial straw that broke IQWiG's back, that withholding may result in a regulatory crackdown.