Pfizer has become the latest pharmaceutical company to move towards making information from clinical trials it sponsored available. From January 2014 Pfizer is going to launch a portal through which qualified researchers can request access to anonymised patient data from completed trials of approved (or discontinued) medicines and indications. And Pfizer is going to publish synopses of clinical study reports on its website for trials dating back to September 2014. Read Pfizer’s statement here.
In response Ben Goldacre, author, doctor and co-founder of AllTrials said:
“While any forward movement from industry on transparency is welcome, this statement from Pfizer contains the same loopholes that we have seen from industry for many years.”
“For example, they exclude “off-label” studies from transparency, even though such uses are commonplace. In fact, Pfizer have received extremely large fines for promoting exactly this kind of off-label uses for drugs such as valdecoxib, ziprasidone, pregabalin, tolterodine, and gabapentin, to date. Since Pfizer know that these uses are commonplace, and they have promoted these uses themselves, then it makes no sense for them to say that the trial data on these uses should be kept secret. “
“It also makes no sense to exclude older trials: those trials are on the very drugs that we are using most commonly, right now, in everyday clinical practice.”
“Lastly, “summaries” of CSRs are unacceptable. The recent PLoS paper from researchers at IQWiG showed clearly that large quantities of important information on results and methodological shortcomings are only available in full CSRs. That is why the AllTrials campaign calls for CSRs to be made publicly available.”
“Medicine has changed, and there is an inevitable policy trajectory towards greater transparency. Pfizer should show true leadership, and recognise that their loopholes inflict unnecessary harm on industry’s reputation. They should commit to sharing all results, on all trials, of all uses, of all medicines currently being prescribed. And they should join others in signing up to the AllTrials campaign, to drive transparency forwards throughout the sector.”