consistent with the best practices of science, which relies on rigorous independent validation of results to reach conclusions of truth.
Here’s how far the industry was willing to go on that score:
“All company-sponsored clinical trials should be considered for publication in the scientific literature irrespective of whether the results of the sponsors’ clinical trials are positive or negative.”
“Should be considered?” That sounds like nothing but lip service. Pharma should be making an unequivocal commitment to publish the summary results of all company-sponsored trials.
There are just too many restrictions, conditions, and half-hearted gauzy sentiments in these guidelines for them to be considered a step in the right direction.
It’s true that the guidelines only set a minimum bar for disclosure, and companies (GlaxoSmithKline, for one, has been a leader on this count) may choose to be more progressive with their disclosure policies. But that’s not going far enough. The industry should be working hard on finding ways to effectively anonymize clinical data to protect patient privacy, and then dump both patient-level and summary-level data into open databases in an automated fashion. By setting up their scientific committees, and deciding who is a “qualified” scientific applicant, pharma is acting like the fox watching the henhouse. That won’t rebuild the credibility they’ve lost, or inspire anyone’s trust.
The pharma industry, like many others, fears change. It needs to get over its fears, and start thinking more creatively. Is it possible that with greater openness, and sharing data among thousands of scientists in industry and academia, companies might gain new insights to help them break out of their R&D funk? Might it shorten drug development timelines, and steer money toward projects with a greater chance to succeed?
If you read the public statements of the industry, it looks like they aren’t even seriously considering that notion. A quote on the European pharma industry group’s website says:
“Through collaboration, we must find better ways to share data and new ways of working together. We must find a balance between when it is appropriate to share data and when it is not. After all, we will not be able to continue our work of bringing benefits to patients unless we are also able to derive suitable commercial return from our ideas.”–Neil Weir, Senior Vice of President of Discovery at UCB Pharma and member of EFPIA’s Research Directors Group.
Let me translate. First half: “The critics might be onto something.” Second half: “We have to keep doing business as usual.”
Things are changing. The Internet era demands openness. Individual patients, aware of the explosion of data coming from genomic research tools, are increasingly demanding access to their personal health data to make better choices about treatment and wellness. Companies in other industries are realizing the benefits of openness, and they’re gravitating to decision-making based analyzing open sets of “Big Data.” If the pharma industry wises up, it will not have to be dragged into the era of openness kicking and screaming. It will grab this opportunity to both fix its faulty R&D model and rebuild public trust.
It’s a moment in time that shouldn’t be wasted.
