Infuse: The Value of Independent Analysis

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News point to the need for greater airing of data produced in industry-funded clinical research. Since 2007, companies have been compelled to disclose that clinical trials were being conducted on a U.S. government website, clinicaltrials.gov. However, publishing data collected in these trials, along with conclusions about the therapies’ risks and benefits, was not compulsory.

For Medtronic’s Infuse, one of the most important innovations in orthopedic medicine, the absence of published became an obstacle.  Yale University, which received a $2.5 million grant to enable researchers to access data of commercial treatments, showed how valuable it can be to make data widely available.

Infuse consists of a genetically engineered protein, named bone morphogenetic protein-2, that stimulates bone growth. Infuse was positioned as a better alternative to bone grafts for patients that required spinal surgery. Although it was designed to help bones heal better after surgery, over time some surgeons raised concerns that Infuse contributed to male sterility, infections and cancer. There were also allegations that doctors who wrote key studies backing the technology had a vested interest in the research outcome by virtue of consulting fees and royalties they earned.

The Yale University professor in charge of the project, Harlan Krumholz, told Bloomberg News, “I remain concerned that products like these are approved with too little study before they reach the market and too little afterwards.”

While medical treatments and medications undergo a rigorous process in order to gain FDA approval,  there are instances where doctors may use a treatment in a different way or for an indication different from that originally intended. This is what happened in the case of Infuse.

Medtronic voluntarily agreed to release Infuse’s data, which was reviewed by two separate research teams, one at Oregon Health & Science University and the other at the University of York (U.K.).

Both teams came to the same conclusion that the product “offered no additional benefits beyond the normal benefits” of the spine surgery, said Rongwei Fu, the lead author of the Oregon study.

The teams came to different opinions on whether Infuse was linked to increased cancer rates. One team concluded that the early research on Medtronic’s bone-growth was biased.

Dr. Fu also wrote that it was difficult to identify “clear indications” for using the product.

In an editorial accompanying the announcement in the Annals of Internal Medicine, researchers from the University of Wisconsin and the University of California, San Francisco said that Infuse may be a reasonable treatment for some injuries in the lower spine, but there is no supporting evidence showing Infuse’s benefit for the treatment of injuries in the upper spine . The editors of Annals also wrote this story shows that systematic reviews constitute the best evidence for clinical practice.

At Databean, we openly and transparently publish clinical findings. We look forward to objective reviews of data from post surveillance, patient-level clinical trials.

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