Medtronic Inc. said it will make the data on its embattled bone-growth product Infuse available to the public and pay for two independent analyses of the information in a move the company says may set a new industry standard.
Medtronic, the world’s biggest maker of heart-rhythm devices, will pay Yale University $2.5 million to assemble a steering committee, hire two research organizations to review studies of the bone product and design a database that can be used by outsiders to get access to the information. The findings should allay concerns about potential risks from Infuse and may set a precedent for health-care companies, said Rick Kuntz, the Minneapolis-based company’s chief scientific officer.
A series of reports released June 29 in The Spine Journal criticized the company for failing to disclose financial ties to Infuse researchers and to report serious side effects in spinal-fusion patients treated with the product. The company plans to post its clinical trial results on the National Library of Medicine’s clinicaltrials.gov website, Kuntz said in a telephone interview.
“We were taken aback that there was a concern about the trustworthiness of the data with Infuse, especially since it passed the regulatory hurdles,” Kuntz said yesterday. “Had this information been publicly available, I don’t think the conclusions that were reached would have been reached.”
Infuse, a genetically engineered protein, was approved by U.S. regulators in 2002 to spur the growth of new bone after spinal surgery. Medtronic conducted 13 clinical trials involving 780 patients, according to the Spine Journal’s review. Infertility in men is among the product’s unanticipated side effects, the review found.
“It’s a historic agreement and one I hope will set a standard for everyone else in the industry,” said Harlan Krumholz, professor of internal medicine, epidemiology and public health at Yale, who will lead the work. “For too long we’ve been in a situation where questions are raised about the safety of a product but companies don’t share the information.”
While there is concern that the information might be used by plaintiff’s attorneys or rivals, the Yale group will serve as an intermediary to ensure the data is handled appropriately, Krumholz said. The two new analyses, which will include information on individual patients, should be available within six months, he said.
“In the end, I think we are going to say goodbye to an era when some of the data that will be helpful to make a treatment decision is hidden from public view,” he said. “This is a first step. No other company has done this. There are risks, but the risk of not sharing the data is even greater.”
Medtronic’s moves are a “sea change” in how big companies interact with the academic community, Eugene Carragee, chief of spinal surgery at Stanford School of Medicine near Palo Alto, California, said in a telephone interview.
While it is a good first step, questions will remain after the analysis is done, he said. Infuse is predominantly used in surgeries that haven’t been studied by Medtronic, Carragee said. Thus, the two reviews and the database won’t provide any clear answers for those patients, he said.
“They simply are not going to have enough data on the main usage of it to give a really precise estimate of how safe or dangerous it is,” said Carragee, who is editor in chief of the Spine Journal and led the publication’s review of Infuse.
The main problem with the published Infuse trial results is that they didn’t include the product’s complications, Carragee said. Surgeons didn’t know to look for things like cancer and male sterility, he said. That will reduce the number of cases reported to the company and U.S. Food and Drug Administration, and they won’t show up in the analysis, he said.
“The accuracy of that has been severely impacted by 10 years of telling everybody that there are no problems,” he said. “I never reported a male sterility event to the company or the FDA because I didn’t think it was a complication of the product. It’s the same thing for infections or cancer or bladder problems. It was all news to us.”
Exposing data that normally remains confidential is a two-edged sword, Kuntz said. The disclosure will make Medtronic vulnerable to inappropriate use of its information that may exaggerate the benefits and harms, he said. It may also turn up new findings, he said.
If the process is successful, the company may release results for other products in a similar way, Kuntz said.
“We understand those risks and benefits and we’re willing to take the risk,” he said. “We really want to find the truth about all of our therapies so we can help our patients and act appropriately.”