“This is the beginning of the end for a dark era in medical history.”
- Dr. Ben Goldacre

“If you put yourself in the position of a patient, or a relative of a patient, what would you want to know? Answer: Everything.’”
- Frank Rockhold, Sr. V.P. of Epidemiology, GlaxoSmithKline (GSK)

GlaxoSmithKline, (GSK) world’s 4th largest pharmaceutical company 100,000 employees; 2012 revenue $41 Billion; 2012 net income $8 Billion

Pharmaceutical giant GlaxoSmithKline has announced its support for the AllTrials campaign, which means that the company is committed to publishing all of its clinical trials. (H/T: Olivia Solon; Wired in the U.K.)

The results of clinical trials are often withheld when the results are not deemed favourable -- i.e. they conclude that a drug is not as effective as its competitors or has worse side effects. This leads to a phenomenon called publication bias, whereby trials with "positive" results are much more likely to be published. This, in turn, distorts the evidence base and can lead to healthcare professionals making decisions about drug prescriptions that would differ if they had access to all of the trial data. And this can harm patients.

The AllTrials initiative campaigns for the publication of the results from all clinical trials -- past, present and future -- on treatments currently in the market.

GSK's announcement comes a year after it was stung with a record $3 billion fine, which had been issued in part because the company withheld data about the damaging side effects of its diabetes drug Avanda. Eight out of ten of the largest Pharma’s have been fined for similar reasons.

However, from now on GSK has committed to making the Clinical Study Reports (CSRs) for all of its medicines available. These are formal reports that provide more details about the design, methods and results of clinical trials.

GSK will release the data for all trials dating back to the formation of the company in 2001.

Tracey Brown, Director at Sense About Science, said that the move was "very important" for a number of reasons: "This will hopefully put a stop to the ridiculous obfuscation and foot-dragging that have characterised reactions to AllTrials from some other parts of the medical industry."

She adds: "GSK say in their statement that they owe it to patients who have taken part in their trials. I think that is very, very true. Companies who have yet to take this seriously should ask themselves where they want to be a few years from now."

The business case benefits are twofold, according to GSK. First, full disclosure filters through into the way the company works, helping to make it more transparent at every level of business. Second, it begins to break down barriers with external audiences. The pharmaceutical industry has generally done a poor job of explaining the complexity, time and risks involved in bringing a drug to market. By being more open about its internal processes, it stands a better chance of gradually improving public trust.

Today is May 7, 2013. We have 50,770 signatures on the petition.
Lend your support; sign here: http://alltrials.net/
all trials registered; all results reported.

7th May 2013
GlaxoSmithKline (GSK) today announced progress on its commitment to share more detailed data from its clinical trials.
In response to the GSK announcement Dr. Ben Goldacre said:

“GSK have made some great promises, and I hope they will deliver. Perhaps most significant is the discussion of collaboration with other companies, to develop a shared platform for access to trial data. These are systemic issues, and first movers will have a huge advantage.”

“There is an outdated view in some corners of industry that transparency is somehow optional, and that this issue can be wished away. Those backward looking companies, organisations, and individuals are taking a huge reputational hit, for little or no gain. It’s time for them to accept that the world has changed around them, show clear leadership, and move towards greater transparency.”

“Doctors, researchers, and patients need access to all the results, for all trials, of all uses, of all currently prescribed treatments, to make safe and informed decisions about which is best. The only discussion to be had on individual patient data is best practice for greater transparency. As the EMA have said: we need to discuss how, not whether, this will happen.”

You can read more details on the GSK announcement here: http://www.gsk.com/media/press-relea...ial-data-.html