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Commitment to transparency in reporting hard data from clinical trials, including post-marketing surveys of adverse events, is lacking.
Nevertheless, the analysts note that because of possible bias from nonresponse to the post-marketing survey and because it was impossible to adjust for many characteristics that may influence the risk of breast cancer, "a causal relationship cannot be totally excluded, either.
As part of the approval for the manufacturing and marketing authorization of this drug, the Japanese regulatory authority made it obligatory for Pfizer Japan to conduct a post-marketing survey, covering all patients treated with the drug, until data from a certain number of cases will be collected, in order to collect data on the safety and efficacy of the drug as soon as possible and to take necessary measures to ensure appropriate use of the drug.