Braden O'Neill

Hidden data, missing data, withholding data- whatever you call it, not all clinical trial data is publicly available, and we think that’s an issue. Regardless of the description, incomplete data is an impediment to ensuring that patients get the best care possible.

At its heart, evidence-based medicine aims to answer one important question: do treatments or tests do more harm than good? When we talk about appraising studies, we are trying to figure out if doing a diagnostic test, or performing an intervention, is going to help a patient more than it will harm them. Medicine is filled with uncertainty; the tools of EBM enable us as researchers, clinicians, policy makers and teachers to get it right, and we hope that as time goes on, we are able to get it right more and more often.

Making a clinical decision when we do not have all the information at hand is risky. Like driving too fast in foggy weather, practicing medicine on the basis of the results of incomplete clinical trial data sets us up for failure. The example of rosiglitazone (Avandia), in which some of the relevant data was withheld at the time of publication and drug approval, is one such example.

Rofecoxib (Vioxx), the ‘blockbuster’ arthritis pain tablet that was supposed to reduce GI bleeding associated with long-term NSAID use, did just that, in Merck’s ”on-treatment analysis”, which hid those who dropped out of the trial. When all the data was analyzed properly, including the dropouts in an “intention-to-treat” analysis, more people died in the rofecoxib group than in the control group, and the reduced GI events were for naught, made up for in spades by the increase in deaths secondary to cardiovascular events.

These are two of many examples of situations in which hidden data has caused harm, and cost lives. This is why the EBM world has been surprised by GSK’s recent announcement pledging to make all clinical trial data fully accessible to the public. The idea is that by allowing people to access all the data, made entirely anonymous, anyone will be able to analyze and investigate the results of clinical trials.

Several of our Evidence Live 2013 speakers are world leaders in this field- Ben Goldacre’s new book Bad Pharma is fast becoming a best-seller and deals with this topic directly- and the discussion should be lively and controversial when we come together in Oxford at the end of March 2013 for the conference.

For what it’s worth, we applaud the promise; it’s the sort of thing Archie Cochrane was talking about 40 years ago when he set out the challenge to set up a comprehensive repository of clinical trial evidence. But if history tells us anything, we’ll believe it when we see it.

“But, by the words we speak and the faces we show the world, we force the spring.”

The beginning of Bill Clinton’s first inaugural address seems an odd place to start a discussion about epidemiology, I admit. For us, though, it reflects the developments over the past few months that have changed how evidence-based medicine is practiced, and how it’s going to look in the near future. And we’re excited about all of it.

It’s no secret that there is massive pressure on drug companies to fundamentally change how they operate. This push for a new era of accountability is due to the efforts of many people, including Ben Goldacre, whose Bad Pharma has become an international phenomenon, and Tom Jefferson and Peter Doshi, whose campaign to obtain all the data on Tamiflu has been a major driver towards exposing withheld data. The current state of pharmaceutical research is a little like when you were in school doing an experiment, and something didn’t quite turn out right, and you ‘forgot’ to write down the results for that one part of the experiment. It may have worked in high school, when the worst that could happen is that you would have to stay after class. But when billions of pounds and thousands of lives are at stake, the stakes are quite different.

The All Trials campaign- an online petition that’s rapidly gaining publicity and support- now has over 25000 signatures, including major medical journals (our EvidenceLive partner, the BMJ, is one of the instigators of the campaign). Last week, pharmaceutical giant GSK signed on – an incredible step in the right direction for an industry that continues to be, in large, stuck in the dark ages when it comes to transparency.

This week, another campaign has started to heat up, this time questioning how guidelines are developed and where the incentives lie in their creation. Bad Guidelines has initially targeted the “Guidance on collaboration between healthcare professionals and the pharmaceutical industry” as a particularly egregious example of a document that august institutions, such as the UK Department of Health, have signed on to and probably shouldn’t have. At the very least, one wonders if they read it through before signing up.

The philosopher Thomas Kuhn suggested that the history of scientific progress has been one of paradigm shifts, in which research continues along in a certain paradigm until someone comes along to break out and move on to another radically different way of looking at phenomena. We can’t help but wonder if we are in the midst of a paradigm shift in healthcare- one that values transparency, scientific progress, and responsibility to patients above all else. If you haven’t already signed up, come to EvidenceLive, and help “force the spring” towards a new era in evidence-based medicine.