Pharma companies have been feeling the heat for years from people who argue they must be more transparent with raw clinical trial data—including the good and the bad—so that independent researchers can verify their claims and learn more from failed studies that traditionally get buried.
Today, Johnson & Johnson is planting a stake in the ground on the issue of transparency, and claiming it will go further in the direction of openness than other pharma company.
New Brunswick, NJ-based J&J (NYSE: [[ticker:JNJ]]), the diversified maker of drugs, medical devices and consumer health products, is announcing today it has struck an agreement with the Yale School of Medicine’s Open Data Access Project (YODA) to open up access to all of its company-sponsored studies. Other companies have taken steps in this direction, such as GlaxoSmithKline, but the industry has mostly shied away from transparency partly over fears of violating patient privacy and giving ammunition to trial lawyers suing on behalf of patients who suffered adverse drug reactions.
What’s unusual about this deal is how far J&J has been willing to go to open up its data warehouses. Instead of setting up its own committee of industry vets to evaluate the scientific merit of data requests—and suffering from a fox-watching-the-henhouse ethical problem—J&J is handing over that decision-making authority to independent, third-party experts at Yale. J&J has also said it will honor scientific data requests going as far back in time as its data are available, and it will provide richly detailed clinical study reports and patient-level data—not just summaries of the type that get published in peer-reviewed journals.
“It’s unprecedented. It’s an extraordinary donation to society, saying scientists around the world can have access to their clinical trial data,” said Harlan Krumholz, a professor of medicine at Yale who helped craft the deal with J&J. “It honors the patients who participated in the trials and the scientists who helped design the studies. Many of these trials were never published. But now they’re willing to engage in a crowdsourcing of science. They are allowing people to generate new insights.”
One leading advocate for open-source biology, or pharmaceutical data transparency, was less enthused at first glance, however. Stephen Friend, a former Merck executive and now CEO of Sage Bionetworks, said he needs to see more of the details of the agreement before declaring victory for transparency activists.
“I don’t think not possible to express enthusiasm, beyond a general sense, for something without first understanding the criteria by which people are going to say ‘I’ll agree, or not agree’ to make something public,’” Friend said.
The pharmaceutical industry, as everyone who has read newspapers the past 10 years knows, has been dogged by a series of drug safety scandals and public outrage over the industry’s desire to keep raw safety data hidden from independent prying eyes. Names like Vioxx and Avandia and Ketek and fen-phen are just a few of the names synonymous with this common practice of keeping data hidden, and declaring it must be that way to protect trade secrets.
As the world has become increasingly connected in the Internet age, and people have begun to see the benefits of openness (fresh scientific insights), in context with the risks (potential privacy violations and legal ammo), pharma has started to make some steps in this direction.
Joanne Waldstreicher, J&J’s chief medical officer, and a prime mover inside the company for this new agreement with Yale, said the company is doing this because
