Outside Review of Clinical Data Finds a Spinal Treatment’s Benefit Overstated

The evidence, published on Monday in a medical journal, is the first fruit of a movement aimed at helping doctors and patients make better treatment choices. Its goal is to have companies make clinical data about a drug or a medical device available to a wide range of researchers, not just a few handpicked ones.

The development is the latest step in an evolving, decade-long push by patient advocates to make the practice of medicine more transparent. As a result of that effort, companies have recently started disclosing their payments to doctors and medical journals now require researchers to reveal any financial ties to a study’s sponsor.

By getting companies to release study data, advocates say, outside experts can vet whether reports in medical journal about the tests are accurate and complete. The concern is that the reports, which doctors rely on to learn about a treatment, can be shaped not only by financial factors but also by the personal agendas of the researchers involved.

“To improve the care of patients, clinical trial data, protocols and results need to be made more widely available and shared for public benefit,” according to an editorial in Annals of Internal Medicine, which published the Medtronic-related reports.

Medtronic’s decision to release data about spinal treatment followed charges in 2011 in a medical journal that company-sponsored studies about the product had overstated its benefit and played down its risks. Other producers are weighing the impact of adverse publicity if they decide not to follow suit against the possible impact on sales if they do.

Such decisions by companies are likely to unfold slowly rather than in a rush. In October, the drug giant GlaxoSmithKline said that it would release the data from all clinical trials of a drug after one is approved or abandoned. In April, Roche, faced by growing demands, said it would soon release all data collected during studies of its popular influenza drug, Tamiflu.

The Medtronic product at issue, which was first sold in 2002, is a bioengineered bone growth protein called Infuse that is used in spinal fusion, a common procedure performed to reduce back pain. Starting about a decade ago, some studies, including those sponsored by Medtronic, reported in medical journals that Infuse produced superior patient outcomes than the traditional material used in the procedure, a bone graft, and posed little if any risk.

One 2003 report, for example, concluded that Infuse produced “statistically superior outcomes with regard to length of surgery, blood loss, hospital stay, reoperation rate, median time to return to work and fusion rates.”

Many of the Infuse reports were written by researchers who received millions of dollars over the years in consulting fees and other payments from Medtronic, including Dr. Thomas A. Zdeblick of the University of Wisconsin and Dr. J. Kenneth Burkus, a spine surgeon in Georgia. The early reports led to the widespread use of Infuse for the specific type of spinal fusion for which the Food and Drug Administration had given approval and by surgeons as an “off-label” treatment in other types of fusion procedures. By 2011, Infuse was used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year, but by then it had become controversial because of its cost and growing safety complaints.

In 2008, for example, the F.D.A. warned that it had received reports of life-threatening complications when Infuse was used off-label to fuse together vertebrae in the upper, or cervical, portion of the spine.

The controversy reached a climax in 2011, when a medical publication, The Spine Journal, devoted an issue to reports that repudiated the Medtronic-sponsored research, calling it misleading and biased. The journal’s move was significant because it is published by the nation’s biggest group of spine surgeons, the North American Spine Society.