Johnson & Johnson (J & J) have decided to embrace the release of clinical trial data in a stunning move that heralds a new era for ‘Open Science.’ In a world where brand management and brand recognition drive scientists, engineers, and designers behind closed doors to dream up, invent, and concoct new medicines, machines, and wares to gain advantage over competition, a stunning new development has unfolded. Johnson & Johnson are making the bold move to potentially release all data through The Yale School of Medicine’s Open Data Access Project (YODA).
YODA will act as the service counter for applications from physicians wanting access to data from J & J products. They will receive applications from outside scientists and researchers and screen each one and decide which deserve the data. To begin with the sharing will be limited to products from the drug division, later however the sharing will extend to other consumer products and devices such as artificial knees and hips.
This new move toward Open Science by Johnson & Johnson is not the first by a large pharmaceutical company, but it is the most comprehensive as it will include numerous drugs already on the market. Medtronic and GlaxoSmithKline PLC have also offered to embrace the sharing of data in the past but in their cases it only covered a single drug. J & J will also include more detailed unidentified individual patient reports.
That difference is what has created the buzz around J & J’s decision to open the doors. In the words of Joanne Waldstreicher, MD, Chief Medical Officer at J & J;
“We really wanted a broad approach to contributing to advancing medical science through all of our products that touch patients in different ways.”
The potential for new discovery grows exponentially when the doors are flung open. Instead of having a group of separate closed door studies taking place with the results remaining “top secret,” there is now a chance to leapfrog ahead in many areas of development as resources are pooled.
The data to be released does not just cover successful research, but also negative data from failed research which can alleviate wasted time and money in other directions. The raw information will offer up many clues to help researchers find the right direction for research.
On J & J’s part, the embrace of Open Science is also seen as a way of garnering credibility. In a move toward greater transparency J & J hope to build trust with doctors and patients which has been badly shaken over the past couple of decades by belief that certain drug benefits were being overstated while negative side effects were being downplayed. With this latest move J & J are inviting both doctors and patients to study the data so more informed decisions on treatment can be made.
The new transparency from J & J came about when Waldstreicher was invited to visit Yale by an old Harvard classmate, cardiologist Harlan Krumholz. Krumholz, a proponent of Open Science, shared with Waldstreicher that he believed that by not sharing the data gleaned from patient studies they were compromising their promise to the patients that their contributions would be used for the good of society.
Johnson & Johnson has taken a giant first step in fulfilling those promises and their new embrace of Open Science may well spur other companies to follow suit.
By Scott Wilson