A leading independent German scientific institute has accused Pfizer Inc. of concealing data about its antidepressant reboxetine, which is sold in Germany under the label Edronax but has not been approved in the United States.
The Cologne-based Institute for Quality and Efficiency in Health Care said in a press release Friday that Pfizer has refused to provide a complete list of all published and unpublished trials on reboxetine. The Institute discovered through its own literature search that the drug approved in Germany has been tested in at least 16 trials. However, in nine of these 16 trials, key information is missing that would enable an evaluation of reboxetine's performance.
Pfizer did not immediately respond to a late-afternoon request for comment, but a German publication, Die Welt, quoted the company as saying that it made sufficient data available.
Pfizer, which has its world research-and-development headquarters in Groton and New London, acquired reboxetine when it bought out Pharmacia in 2003. But the U.S. Food and Drug Administration had previously denied an application to sell the drug in this country.
By 2007, the drug had been approved for sale in more than 50 other countries, including Germany, and, though its effectiveness compared to other antidepressants has been called into doubt, patients may still legally have it imported into the United States with a doctor's approval.
But the German institute called into question the use of reboxetine, saying its preliminary estimation is that there was no proof of benefit ... from the data currently available.
A German governmental committee commissioned the report, which blasted a few other companies while lauding the work of GlaxoSmithKline, which recently upgraded its policies to allow more transparency in drug studies.
Pfizer itself has a policy that states it will report all studies in an objective, accurate, balanced and complete manner.
Pfizer isn't doing itself or the (pharmaceutical) sector's reputation any good in holding back data, commented the well-regarded In Vivo Blog.
By concealing study data, the manufacturer is depriving patients and doctors of the opportunity to make an informed decision on different therapy options, said Peter T. Sawicki, director of the German institute that issued the report.
He added that it was impossible to draw conclusions about the benefit or harm of drugs without being able to study all available data. Sawicki questioned whether a pharmaceutical-association promise to voluntarily disclose information about all clinical trials is sufficient to make drug companies comply.
Doctors and researchers are often totally unaware that unpublished trials exist, Sawicki's organization said in a release. Companies have repeatedly refused to provide the institute with study documents required for the benefit assessment of drugs.
Sawicki said Pfizer and other companies' failure to reveal all study data constituted publication bias, which happens when a firm's drug did not produce the hoped-for result or even proved to have no effect. Such bias, he said, leads to publication of results only years later or not at all.
Studying the effects of antidepressants is considered tricky because of the placebo effect, which leads to patients feeling better simply because they think a medicine is working. Sawicki said some antidepressant medications may have no effect at all on the illnesses they target, if all the trials are looked at in totality, so many patients could be getting useless treatments.
Deception through concealment is no trivial offense, Sawicki said
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