Industry Promises Increased Transparency, Medtronic InFuse Debacle Cited

drug_company_transparencySome of the world’s largest drug makers have promised to release detailed information about their pharmaceutical products, such as Medtronic’s InFuse, to external researchers.

While many are happy with the move, others point out that this might be a way in which to avoid the more intense and broad requirements pending review in Europe, according to The New York Times. The joint announcement was made by two key pharmaceutical trade groups—Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations. The proposal was approved unanimously by member companies, the Times noted, and becomes effective January 1st for new drugs and new uses for medications approved in the United States and the European Union.

“Quite frankly, we recognize that there are a lot of skeptics, but this is the right thing to do and the right time to do it,” said John J. Castellani, chief executive of PhRMA. PhRMA developed the guidelines in collaboration with the European Federation of Pharmaceutical Industries and Associations. The groups’ members comprise about 80 percent of the world’s pharmaceutical research, Castellani told the Times.

“What they are doing would have been thought to be inconceivable even a short time ago,” said Dr. Harlan M. Krumholz, a cardiologist at Yale who recently oversaw an external review of InFuse, a bone graft treatment manufactured and marketed by Medtronic Inc. “If these companies truly fulfill these promises, then they will have made an important contribution to science and the common good,” Dr. Krumholz told the Times, cautioning that the efforts require oversight.

InFuse was, essentially, positioned as a solution that meant the end of the need to harvest bone from patients’ hips in vertebrae fusions, according to Healthworks Collective. But the two independent studies, overseen by Yale University, reveal important key findings regarding Medtronic’s InFuse product—namely, that there is little, if any, difference in the efficacy of InFuse over traditional bone graft. InFuse, a protein-based bone growth stimulator known as rhBMP-2, has been tied to dangerous side effect, including (to name just a few) retrograde ejaculation, cancer, pain, and extraneous bone growth.

Medtronic approached Yale University researchers after a June 2011 study published in The Spine Journal disclosed that Medtronic-paid researchers failed to report serious potential complications associated with InFuse in spinal surgery. The accusations, wrote BMJ, included that Medtronic minimized InFuse’s adverse responses. The Yale-commissioned studies, known as YODA (Yale university Open Data Access) reviewed the clinical trials that compared rhBMP-2 with traditional iliac crest bone grafting, according to BMJ.

The YODA reviews concluded that InFuse was no better than traditional bone graft in efficacy outcomes, for instance, with pain or function, a surprising finding, noted BMJ, given that InFuse was touted in literature as being superior to traditional bone grafting. In fact, in a press release, Medtronic stated, “these [YODA systematic review] findings are consistent with those in the original clinical studies.” Both review teams also discovered a number of issues with the published literature on InFuse concerning the “substantial evidence of reporting bias.” The researchers also found that among the published trials, only 56-88 percent of known efficacy outcomes were reported and six of 17 of Medtronic’s clinical trials—three of which were randomized, control trials—were never published, according to BMJ. Just 23 percent of the known adverse events recorded in the InFuse trial data were ever discussed in the journal publications.

Neither review reached any strong assumptions concerning InFuse safety; however, both noted potential increased cancer risks; that safety data were not systematically collected in the trials; and that Medtronic’s own non-standardized “in house” coding system—developed in collaboration with the U.S. Food and Drug Administration (FDA)—were used to classify adverse events associated with InFuse.

In 2008, the FDA issued a safety alert to warn about the use of InFuse off-label in upper spine and neck procedures after receiving dozens of reports of serious side effects that include, according to the FDA, are swelling of neck and throat tissue, resulting in compression of the airway and/or neurological structures in the neck; difficulty swallowing, breathing, or speaking; nerve damage; and severe dysphagia.

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