Two independent studies found a controversial Medtronic Inc. (>> Medtronic, Inc.) bone-growth product for spine surgeries was no better than a traditional operation. The studies were the result of a two-year experiment in lifting the veil on industry-sponsored trial data.
Medtronic's product, called Infuse, has been plagued by allegations that doctors who wrote key studies backing the technology received millions of dollars in royalties and fees related to other work and may have understated risks.
The company took the unusual step of handing over detailed trial data on Infuse to a team of Yale University experts, along with a $2.5 million grant. Yale hired outside researchers to analyze the data.
Overall complication rates for the back-pain surgeries were similar regardless of whether Infuse was used, according to the studies, published in the Annals of Internal Medicine. One of the studies, by Oregon Health & Science University researchers, linked Infuse to increased cancer rates after two years.
But cancer risks remain small, the researchers said, and the other study, by researchers at the University of York in the U.K., didn't detect a cancer link.
"We found the product offered no additional benefits beyond the normal benefits" of the spine surgery, said Rongwei Fu, the lead author of the Oregon study. Coupled with the increased cancer risk, the study said, it was difficult to identify "clear indications" for using the product.
"We found a lot of reporting bias in [Medtronic's] published papers that tends to overstate the benefits and downplayed the risks," Dr. Fu said, citing, for example, failing to include certain complications.
In the traditional procedure, surgeons extract bone from patients' pelvises and use it to stabilize vertebrae. Infuse, a genetically engineered protein, prompts bone growth, eliminating the need to harvest the extra bone. The hope was that would reduce complication rates and limit pain.
Medtronic said it believed the research supported Infuse's Food and Drug Administration-approved uses in a spine procedure. The product is widely used off-label for other procedures, including in the neck.
Researchers heralded Medtronic's move to voluntarily release its data cache as a transparency milestone. Medical journals often publish research financed by drug and medical device makers, but many industry-funded studies are never aired. Researchers and physicians worry that negative results are buried and risks understated to make products look better.
"We have a health-care system that's built on evidence that's incomplete and not missing at random," said Harlan Krumholz, the Yale cardiologist who devised the Yale Open Data Access Project, or Yoda, and forged the Medtronic deal.
Dr. Krumholz praised Medtronic for "setting a precedent" by providing the data.
Medtronic said it would continue to participate in such efforts. Opening access to data "for physicians to make informed therapy decisions .. makes a lot of sense to us," said Chris O'Connell, the Medtronic group president overseeing the unit that makes Infuse.
The project comes amid broader pressure to release trial data. Since 2007, firms have been required to disclose the existence of clinical trials to a U.S. government website, ClinicalTrials.gov. But they aren't required to publicly disclose results.
Last month, GlaxoSmithKline PLC (GSK, GSK.LN) offered outside researchers a new process to gain access to some of its trial data. "There's been an appetite to have access to this for quite a period of time," said Perry Nisen, the U.K. drug maker's senior vice president for science and innovation.
Dr. Nisen waved off concerns that rivals could use such data to call into question the company's products, saying, "the truth has to prevail."
More data access could allow outside researchers to track the effectiveness of specific drugs in certain subgroups of patients, such as diabetics or older people, and to compare treatments to see which are most effective, said researchers such as Deborah Schrag, an oncologist at the Dana-Farber Cancer Institute in Boston.
In Medtronic's case, transparency didn't immediately provide clarity.
Medtronic's Mr. O'Connell said the studies reinforce "what we've always believed: that Infuse is an important option for many patients." More than one million patients have received the product, he said, adding that the company would continue to seek FDA approval to market it for other uses.
By contrast, some doctors expressed reservations. "I will probably use [Infuse] seldom in my own practice until I get better and clearer data in terms of what maybe some of these potential complications are," especially cancer risks, said Michael Schafer, an orthopedic surgeon at Northwestern Medicine in Chicago.
Eugene Carragee, a Stanford University professor of orthopedic surgery and the author of a 2011 Spine Journal article that suggested Medtronic's trials understated risks and sparked much of the Infuse controversy, said he hoped the results further limited Infuse use, which has declined in recent years.
The Senate Finance Committee investigated whether Medtronic payments to its researchers influenced the results they reported. A Senate report in October alleged that Medtronic paid those researchers a total of $210 million for company-related work, largely in royalties for other products.
Medtronic said it has limited the role of doctors who earn royalties for its products in conducting related research.
Write to Christopher Weaver at [email protected]
(CORRECTION: This article was corrected because the headline mischaracterized Medtronic's bone-growth product Infuse as a drug.)