YODA's the name;
open science is the game

In a striking experiment in research transparency, a Yale-managed project has used a medical company's own clinical data to rebut its previous claims about a product.

"If open science is to take flight in the traditionally secretive worlds of drug and medical device manufacturing," Forbes says, "it may well look something like this."

The company is Medtronic, a $16 billion-a-year manufacturer of medical devices. The research concerned a bone-graft product called Infuse, which Medtronic touted as superior to existing techniques.

Medtronic ran into trouble when it was revealed that studies portraying Infuse as a breakthrough "were drafted and edited with direct input from company employees, while the doctors listed as authors were paid millions," according to an account of a Senate investigation.

To clear its name, Medtronic turned to Yale and Harlan Krumholz ’80. A cardiologist at the School of Medicine, Krumholz directs the Center for Outcomes Research and Evaluation and is an outspoken advocate of transparency in scientific research.

With a $2.5 million grant from Medtronic, Krumholz created the Yale University Open Data Access (YODA) Project. The company turned over all of its clinical data on Infuse. Yale, in turn, hired two independent research groups—at Oregon Health & Science University and University of York in England—which analyzed the information without conferring with each other.

Their findings, published this week in the Annals of Internal Medicine: compared to conventional spinal-fusion techniques, Infuse works about as well, but not better. Complication rates are similar for some procedures; for others, Infuse patients had more complications. Data about a possible higher cancer risk seem inconclusive.

The articles are available for free online—which is often not the case with scientific journals—and YODA will make the clinical data available to other scientists on request. In an Annals editorial accompanying the research, Krumholz and collaborators call it "A Historic Moment for Open Science."

"Nearly half of clinical trials are never published, and many that are have long delays in publication," they write. "Among those published, the information is often incomplete. Evidence suggests that some data are not missing at random."

In a statement on its website, Medtronic says it is "pleased to have reached this milestone in the completion of the systematic reviews. The results add to a growing body of evidence regarding INFUSE® Bone Graft as a safe and effective treatment option in FDA-approved indications for use."

But news accounts take a different spin.

"Studies fail to back Medtronic spine product," says the Wall Street Journal. "Treatment’s benefit overstated," says the New York Times. "Yale study raises questions about integrity of previous studies," says the Star Tribune of Minneapolis, Medtronic's home town.

Krumholz, characteristically, accentuates the positive.

“My hope is that this catches on," he tells the Star Tribune. "That this serves as a catalyst,” Krumholz said. “My hope is that this can restore public trust in these companies.”