Open Medicine EU

In December, I argued for more transparency in relation to clinical trials, and hoped that the Commission would take up this issue in the forthcoming revision of the Clinical Trials Directive. I thought it might be useful to look at particular cases where more or earlier transparency might have saved lives or reduced harm.

Take the Glaxo diabetes medicine, Avandia (rosiglitazone), withdrawn from the European market in 2010 and subject to severe restrictions in the US. Did the company have information from research that might have led to an earlier withdrawal if it had been made publicly available sooner?

Well, yes, according to the US Senate Finance Committee which accused the company in July 2010 of failing to publish in good time a number of studies that showed problems with Avandia, and of using “ghost-writers”, professional writers paid by the company, to present the results of their clinical trials.

One Glaxo study in particular, of a competing drug Actos, indicated that Avandia had a worse profile, and the Committee cited internal company emails arguing that “…these data
should not see the light of day to anyone outside of GSK…” and that there should be no study comparing Avandia with Actos.

In their response, the company sharply rejected the claims, accusing the Committee of releasing a small subset of the millions of documents in the case, including “..drafts and other documents taken out of context, which therefore are incomplete and misleading”.

The company also said that the Actos study was of a competing product (true) and that the results were consistent with what was already known about the competing product, and “did not contribute any significant new information”.

As for two other studies cited by the Senate Committee the company said that they had submitted the data from these studies to the US FDA.

On the allegation of ghost-writing the company said that they follow, and did follow in this instance, “…established authorship practices modelled after the International Committee of Medical Journal Editors (ICMJE) guidelines…”

I have taken the Senate Committee’s intervention here because it is relatively easy to describe in a blog, but there had been many complicated controversies about Avandia for some years previously. You can read more about Avandia, and the case for more transparency, in an article by Peter C Gotzsche entitled Why we need easy access to all data from all clinical trials and how to accomplish it.

In future posts I will look at other cases that seem to me to illustrate the need for more transparency in relation to clinical trials. I have also intended for some time to look at medical writing, sometimes pejoratively described as “ghost-writing”. This is the widespread practice of pharmaceutical companies employing professional writers to prepare drafts of reports of clinical trials, for submission to peer-reviewed journals. END

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