Birth Defects, Suicide, Aggression, Withdrawal? …What other Seroxat side effects have GSK concealed in their clinical trial cupboards?
GSK’s Manifesto: Voyeurs of the World Unite!October 9, 2013 3 Comments
Editorial Note: There is a widespread impression that the pharmaceutical industry are split on the issue of access to clinical trial data with the bad guys like AbbVie taking legal actions to block access and the good guys like GSK in favor of transparency. An editorial like this one from GSK’s James Shannon in the Huffington Post on September 3rd might support such impressions. See Neal Parker Avoiding Adverse Events.
Nothing could be further from the truth. A recent House of Commons report on Clinical Trials in the UK, which entols the supreme virtues of GSK at every possible turn, contains the following summary recommendation:
“We are not in favor of placing anonymized individual patient-level data (IPD) in the public domain in an unrestricted manner… specific individuals should be provided with controlled access to IPD through carefully managed and secure “safe havens”. Access should be facilitated by an independent gatekeeper responsible for ensuring that the data … makes a useful contribution to scientific understanding”.
This is GSK’s preferred way to deny access to the data written into a House of Commons recommendation. In practice, as outlined in April Fool in Harlow. GSK are offering an opportunity for voyeurism rather than the full-bodied engagement with the data that is science.
Several researchers are at present attempting to write up GSK’s most famous ever clinical trial – Study 329, a study of Paxil given to children, that led to charges of fraud from New York State and contributed to GSK’s recent $3Billion dollar fine. Despite an undertaking given to the Courts to make the data from this study available, GSK are currently refusing to do so – requiring investigators instead to apply through their “safe haven” which seems exquisitely designed to make it impossible to establish what the data actually shows. See Reading the RIAT Act. This is a space to watch.
You’d never guess at GSK’s stonewalling tactics from James Shannon’s editorial below. This editorial suggests the company is supremely confident it has successfully pulled the wool over the eyes of academics and politicians – as suggested last April Fool’s Day – See April Fool in Harlow.
Unlocking Access to Clinical Trial Data – what are we afraid of? James Shannon, GlaxoSmithKline’s Chief Medical Officer. Huffington Post 03/09/2013 Today thousands of people all over the world will take part in clinical trials. Why do they volunteer, willingly sacrifice their time and in some cases experience discomfort and inconvenience? Of course there is the hope that perhaps they can benefit from the medicine under the microscope. But they also do it to contribute something to the wider population – the hope that they can play their part in developing new medicines for diseases like cancer or Alzheimer’s disease that we are still trying to tackle. And I think they expect something else – when that trial is over, regardless of whether it results in a new medicine on the pharmacy shelves, they expect that the data gathered – their contribution – will be used to help others, to drive forward discovery through the scientific community learning from research already undertaken. In recent months the words ‘data transparency’ have found their way into our vernacular, with calls for pharmaceutical companies to be more transparent about their research and to publish results from all their clinical trials. The pharmaceutical industry has been the source of a great many advances and there are many people in the world today living longer, healthier lives because of the medicines researched and developed by the industry. But despite this, it is an industry which still draws criticism and concern. Historically, being open and transparent aren’t traits the industry has been famed for. We haven’t always done a good enough job to be transparent so that people trust and feel proud of how we operate and what we achieve. Increasing transparency about our research is a critical area we’ve been pursuing at GlaxoSmithKline for almost a decade. In 2004 we launched an online study register which means visitors to our website can see any trial that we are running or are about to start. We also post every set of results here, regardless of whether they are positive or negative. Since then we’ve taken more action to increase the information we share, culminating this year with our commitment to disclose detailed reports of our studies and support for the AllTrials campaign, led by Sense about Science and British doctor, Ben Goldacre. We’ve also launched a new website allowing scientists to request access to the very detailed, anonymised patient-level data sitting behind the results of our clinical trials. This will mean independent researchers, with a fresh perspective, can conduct further research which could advance medical science and improve patient care. It’s inevitable that some will still worry that we are hiding something. Honestly, we’re not. GSK is not alone in its drive to increase transparency, as we have seen from the growing support for the likes of the AllTrials campaign. It is obviously for others to decide the approach they take in this space but it is certainly an issue that has captured the attention of not just pharmaceutical companies but academic and public institutions carrying out research. So what could we possibly be afraid of? Concerns have been raised about greater transparency introducing a competitive disadvantage. We don’t see it. People have asked me, “what if a new side effect comes to light for one of your medicines? Or what if a scientist discovers that you made a mistake in your research?” My answer back is “why wouldn’t we want that to happen? Isn’t it better that we know? There is always the potential for us to find a better way to do things.” We still need new treatments to tackle diseases and there are still many scientific unknowns that stand in the way of us developing those treatments. Who knows? Perhaps increased transparency in clinical research and the sharing of knowledge and data will help solve some of our trickiest scientific questions. We hear from scientists that making more information available will be incredibly helpful – it will enable them to study the science behind today’s medicines more closely, combine data from different studies and look at how medicines can best be used. Ultimately this has the potential to improve patient care, which can only be a good thing. There is more to be done. All those carrying out clinical research, whether they are companies like GSK, academic institutions or other research organisations, have a role to play in ensuring information from their clinical trials is made publicly available. There is also a clear need for a broad, independent system to be created where researchers can access data from any trial from multiple companies and organisations. We want a truly independent organisation from the public or charity sector to take on the oversight of this and make it a reality as soon as possible. There is a lot to be gained by having that transparency at the core of how we work. I think science, society and, most importantly, patients, will be better for it. [As for scientists we figure they’ll get by looking]. –