GSKs decision to share data occurs within an industry that has consistently held back information that has relevance to understanding the risks and benefits of its products. Patients face decisions every day and their physicians have been denied access to the totality of evidence about products being sold. Review articles, textbook chapters, and guidelines are all based on only a fraction of the evidence that has been produced in the study of these products. And there is plenty of evidence that the data behind closed doors can have an important effect on the assessment of a product’s risks and benefits – sometimes providing more support and sometimes less. We have allowed this system to persist in deference to the fact that the companies own their data and despite the fact that such shielding of information from the public was not in patients’ best interests.
GSK has not always considered sharing to be a good idea. It was forced by litigation to share summary data from its trials and even then did not promote access. It was that forced sharing that led to the recognition that Avandia (rosiglitazone), the diabetes drug, likely increases the risk of heart attacks. For actions in that period, GSK incurred criminal changes and a $3 billion fine in what has been described as the largest case of healthcare fraud in U.S. history.
Andrew Witty, CEO of GSK, has apologized for past behavior – a virtually unprecedented move in the pharmaceutical industry. Moreover, he stated, “We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organization and displaying integrity in everything we do.”
Many were skeptical about whether there would really be a change. But today, anything seems possible as Witty is making good on his assertion that GSK is entering a new era in its history .
Several aspects of the announcement are worth noting. GSK is making its trial database available to researchers in an attempt to steer the use toward scientific purposes. It is not merely providing summary data, but is sharing patient-level data, which will support a broader array of research and is a higher level of transparency. This issue will seem like a nuance to some readers, but those in the field of medical research recognize it as a major step forward and a signal that the company is serious about promoting open science. I hope that such disclosure is accompanied by a willingness to share protocols and other key information and data – but this step alone is remarkable.
My hope now is that it becomes increasingly untenable for other companies to resist the call to join the world of open science and data sharing. Medtronic, in a project with Yale that I lead, preceded the GSK move by sharing data on an important product, bone morphogenic protein-2, which has revenues approaching a billion dollars. Although many in industry expressed private support, publicly no other company indicated a willingness to follow the example. GSK has now upped the ante.
I think we will look back on today as a watershed moment – predicated on GSK truly embracing the spirit of what they have espoused. Those of us who have been calling for industry leadership had hoped that such sharing would not require legislation, regulation or litigation – but that the companies would see the wisdom of the approach. We hoped that they would move first and, as a result, begin a process of restoring the public’s trust in them. Academics need to catch up to GSK and also embrace the wisdom of sharing data – in many cases their record is currently no better than industry’s.
Other companies should hear the clock ticking. Witty said clearly, “…the complexity of the science and the scale of the challenge mean that we cannot solve these problems alone. We need to take a different approach – one focused on partnership, collaboration and openness.” Until other companies follow suit, they will be at a disadvantage scientifically. I hope they realize that soon.
Today pigs were flying. The improbable became so, and, if GSK is true to what they have promised, society will be so much better for it.
