1 Boring Old Man

Unlocking Access to Clinical Trial Data
What Are We Afraid of?

HuffPost Tech UK

by James Shannon

GlaxoSmithKline’s Chief Medical Officer

3 September 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…

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"…

In pharmacologic research, the scientists often use the word signal to denote some evidence that there’s an effect that needs further study. For Andrew Fleming, it was a halo around some mold in a dirty Petri dish that lead him to Penicillin. But there are other kinds of signals too, and right now, we have every reason in the world to be confused about the signals coming from GlaxoSmithKline. The news from China is beyond disturbing – $490 M in bribes to doctors to prescribe their medications? the $3 B settlement for some pretty egregious sins in the scientific and marketing arenas? the whole Paxil story going back twenty years? the Avandia saga? So are we to simply accept their admittedly positive signals like this article or their support of AllTrials? or is this just another move in a game of chess – a play for control of the game·space? GSK is, after all, a commercial enterprise. We can’t expect them to make moves that are to their disadvantage business·wise. But we can and do expect them to play straight with us. For example, after the $3 B settlement last year, much of which hinged on their infamous Paxil Study 329, their lawyer wrote a letter to the Chronicle of Higher Learning [see the only enduring contract…] that begins:

As counsel for GlaxoSmithKline LLC in its recently concluded settlement with the United States government, I write to correct some significant factual inaccuracies in "Academic Researchers Escape Scrutiny in Glaxo Fraud Settlement" [The Chronicle, August 6]. The piece focuses on a peer-reviewed journal article published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry reporting the results of a clinical trial sponsored by Glaxo­SmithKline [Study 329] of Paxil® [paroxetine hydrochloride] for the treatment of major depressive disorder in adolescents [the article was "Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial," by M.B. Keller et al., in the July 2001 issue]. Unfortunately, your piece incorrectly states that, as part of its government settlement, GlaxoSmithKline admitted that the journal article "was part of the fraud" and "constituted scientific fraud." In fact, GlaxoSmithKline made no such admission and vigorously disputes that the journal article was false, misleading, or fraudulent.

The journal article on Study 329 has become the paradigm case of medical ghostwriting, one that facilitated the misrepresentation of study results for both efficacy and safety, and as a result harmed young patients who were prescribed Paxil in reliance on this article. The fact that GlaxoSmithKline continues to dispute vigorously the report of this study demonstrates, in our view, that the company is still out of step with the company·wide overhaul initiated by the new CEO, Andrew Witty, to prevent "unacceptable" mistakes that led to the record $3-billion fine.

This will mean independent researchers, with a fresh perspective, can conduct further research which could advance medical science and improve patient care.

So while I can understand some of why GSK has taken the position of having an independent board evaluate requests for patient level data, that’s not a good enough signal for me. There’s nothing proprietary about the kind of information being requested. While it might be interesting for some independent investigators for further scientific projects, that’s not the point from my vantage. I’m a doctor who has lost the ability to trust the articles in the medical journals that I rely on to make clinical decisions. If those articles use the shorthand of scientific presentation to regularly distort the facts, I’m not only blind, I’m sent down a false path. I didn’t go to medical school for that. The signal I’m looking for is data transparency up front, no restrictions, all the time.

I can conceive of rare exceptions, situations that fit the ramblings of AbbVie’s Neal Parker [a deal-breaker?…, a window…] mentioned in the last posts. In those situations, they could petition in advance for those exceptions and make it very clear to me as a doctor that they aren’t going to reveal certain things. Then we could make our own decision, my patient and I, about using their medication. I’m pretty sure I wouldn’t prescribe in those circumstances, but who knows? At least we could make an informed decision.