it wants to advance science. Krumholz raved about the company’s willingness to do that, saying the company didn’t refuse any request he made to do the data transparency initiative the right way. He did say the ‘terms and conditions’ of the data sharing agreements call for users to have a valid scientific request, and not to request data for a commercial or litigious purpose. But naturally, he said, that will be hard to stop in practice.
Waldstreicher, in an interview, added that J&J has “always believed in the transparency of our data,” and has worked over the years to honor valid scientific requests. What’s different here is that by handing over authority to Yale, the company hopes to be “more systematic and objective” in how it handles these requests. Yale is particularly well-suited as a partner, she said, because of its expertise in open data access, and ability to handle diversified data sets for drugs, devices, and consumer products, she said.
Waldstreicher said she recognizes there are risks in making so much data available from the company’s data troves. “This is going to be a learning experience,” Waldstreicher says. “We’ll start it and see how it goes. If there are challenges, and constructive input, we’ll incorporate those and learn along the way.”
Every effort will be making to make patient-level data anonymous, Waldstreicher says. But sometimes in the case of rare diseases, with only a handful of patients in a study, it may be impossible to make patient-level data truly anonymous, she said.
Will any other pharma companies follow this lead? Krumholz said he’s spoken to many other companies about similar initiatives over the years, and he’s not sure. “I have talked to other companies about this approach. There’s a lot of resistance or reluctance,” Krumholz says. “What I do find is that when one company shows what’s possible, others do follow.”
