Reboxetine: Pfizer conceals trial data

Published in The Hindu on July 9, 2009

The multinational drug company Pfizer has once again been caught in the act of concealing research data. This time the accusation comes, not from researchers, but from the Institute for Quality and Efficiency in Health Care (IQWiG) based in Cologne, Germany. The IQWiG is an independent scientific institute that conducts healthcare research and evaluations on behalf of Germany’s public health insurance regulator.

The drug in question is reboxetine, an antidepressant approved in 1997 in Germany. The IQWiG has been conducting a ‘benefit assessment’ of this drug and two other drugs for the Federal Joint Committee (G-BA).

According to the IQWiG, reboxetine was tested by Pfizer on about 4,600 patients, suffering from depression, in at least 16 trials. However, the Institute had access to data of only 1,600 patients.

According to the Institute, key information in 9 of the 16 trials was missing. The lack of information prevented it from fully evaluating the drug’s performance. “If the unpublished data are not included, there is a high risk of incorrectly estimating the benefit and harm of this drug agent,” it noted. Based on whatever data was available, the Institute in its preliminary report stated that reboxetine had “no proof of benefit.”

This conclusion has a huge implication for Pfizer. According to the British Medical Journal (BMJ), if the Institute is unable to assess the benefit of a drug because of lack of data, it is highly likely that insurance companies in Germany may refuse to reimburse its cost. The practice of cherry picking positive results and the penchant for concealing negative findings is nothing new for the drug industry. But such concealment often results in incorrect assessment of a drug’s safety and efficacy.

It is to overcome this shortcoming that the Institute had in place an agreement with the German Association of Research-based Pharmaceutical Companies to gain access to such data. But the agreement was of little help. According to IQWiG, Pfizer did not give any reasons for refusing to disclose the data.

“Reboxetine is a safe, effective and well tolerated drug. IQWIG is not a regulatory authority but a private institute. There is no obligation to provide IQWiG with information,” Martin Fensch, head of communications for Pfizer Deutschland was quoted as saying in the BMJ.

The IQWiG is now calling for an EU-wide legal obligation to publish the results of clinical results. The U.S. passed such a law last year.