GSK have received a lot of good press over the past year for their promises of transparency and access to data. They received particularly glowing praise by Ben Goldacre (author of Bad Pharma). However, no real transparency has actually occurred. Even if GSK did fulfill their promises- for Seroxat users and ex-Seroxat users- damaged by the drug- this will be of no use-whatsoever because GSK said they will only be giving (controlled) access to data post-2000 therefore that leaves out Seroxat data (and data for many other dangerous/dubious GSK drugs). So much for transparency!…
Good PR though..
To what extent the Glaxo effort will take hold remains to be seen. Nisen says the drugmaker has, so far, received 10 proposals and about 100 inquiries for data. Already, though, Glaxo has encountered criticism. For one, there is concern that its independent panel, which was established to review data requests, is not fully independent, if only because one member previously worked as a consultant to the drugmaker (see this). Glaxo has refused such assertions.
Separately, the drugmaker is haggling with a group of researchers who want clinical study reports for an infamous study of its Paxil antidepressant. They maintain Glaxo has balked at the request and has raised doubts about its commitment to releasing data. In the process, the dispute has raised questions about whether Glaxo complied with a 2004 consent order with the New York State Attorney General to publicly disclose the Paxil trial data (more here).