Adverse events can occur during clinical trials of spine techniques and devices, but are researchers properly reporting these outcomes and do conflicts of interest ever come into play? A panel of physicians and researchers examined these questions during a session titled "Recording and Reporting of Adverse Outcomes in Spine Surgery: Are We at the Top of Our Game?" at the Academy of Orthopaedic Surgeons Annual Meeting 2013 in Chicago.
Panel members were Sohail Mirza, MD, of Dartmouth Medical School; Paul Anderson, MD, of the University of Wisconsin; Bradley Weiner, MD, of Weill Cornell Medical College; and Brook Martin, PhD, of Dartmouth Medical School.
Dr. Anderson looked at the two main paths for reporting clinical studies: the FDA summary reports and the peer-review publication. While the FDA summaries include an extensive amount of data, it may be too much to dig through to find the important outcomes, he said. FDA reports also provide homogenous results and need better stratification whereas the peer-reviewed literature has better guidelines for variable reporting.
He also pointed out several problems with adverse events, including the lack of consensus definition as to what differentiates an adverse event from an outcome. Peer literature summaries also have to be condensed for print, and thus important details can be left out.
"Surgeons should monitor themselves, and participate in quality assurance efforts," Dr. Anderson said. "We need to critically evaluate new devices before use for safety."
Dr. Weiner looked at conflicts of interest in adverse reporting in light of the Medtronic bone morphogenic protein 2 test results. In the initial, company-sponsored clinical trials of BMP-2, in 2002, researchers reported no complications associated with the device. However, when general use began between 2004 and 2006, physicians began to report complications. And in 2008, the FDA issued a warning of "life threatening complications" associated with BMP-2 for anterior cervical fusions.
In addition to the discrepancy between the first trials and subsequent trials, investigations uncovered that Medtronic was "heavily involved in drafting, editing and shaping the content of medical journal articles," Dr. Weiner said. The company was also paying the some physicians who wrote the articles millions of dollars for unrelated work.
It is evident, Dr. Weiner said, that the complications and adverse events from trials were underreported. However, he added, conflict of interest may not be to blame. After investigations, experts concluded that unethical behaviors happen without conscious thought, especially when given little oversight and money. Thus, any potential conflicts of interest should be eliminated whenever possible.
In learning from this event, physicians should strive for full disclosure of industry connections in every published report. Authors, editors and readers of peer-reviewed publications should also be more vigilant to find potential problems when reading literature, the panel suggests.
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Panel members were Sohail Mirza, MD, of Dartmouth Medical School; Paul Anderson, MD, of the University of Wisconsin; Bradley Weiner, MD, of Weill Cornell Medical College; and Brook Martin, PhD, of Dartmouth Medical School.
Dr. Anderson looked at the two main paths for reporting clinical studies: the FDA summary reports and the peer-review publication. While the FDA summaries include an extensive amount of data, it may be too much to dig through to find the important outcomes, he said. FDA reports also provide homogenous results and need better stratification whereas the peer-reviewed literature has better guidelines for variable reporting.
He also pointed out several problems with adverse events, including the lack of consensus definition as to what differentiates an adverse event from an outcome. Peer literature summaries also have to be condensed for print, and thus important details can be left out.
"Surgeons should monitor themselves, and participate in quality assurance efforts," Dr. Anderson said. "We need to critically evaluate new devices before use for safety."
Dr. Weiner looked at conflicts of interest in adverse reporting in light of the Medtronic bone morphogenic protein 2 test results. In the initial, company-sponsored clinical trials of BMP-2, in 2002, researchers reported no complications associated with the device. However, when general use began between 2004 and 2006, physicians began to report complications. And in 2008, the FDA issued a warning of "life threatening complications" associated with BMP-2 for anterior cervical fusions.
In addition to the discrepancy between the first trials and subsequent trials, investigations uncovered that Medtronic was "heavily involved in drafting, editing and shaping the content of medical journal articles," Dr. Weiner said. The company was also paying the some physicians who wrote the articles millions of dollars for unrelated work.
It is evident, Dr. Weiner said, that the complications and adverse events from trials were underreported. However, he added, conflict of interest may not be to blame. After investigations, experts concluded that unethical behaviors happen without conscious thought, especially when given little oversight and money. Thus, any potential conflicts of interest should be eliminated whenever possible.
In learning from this event, physicians should strive for full disclosure of industry connections in every published report. Authors, editors and readers of peer-reviewed publications should also be more vigilant to find potential problems when reading literature, the panel suggests.
More Articles on Spine:
Stamford Hospital Opens Orthopedic & Spine Institute
Will Spine Surgeons Seek Hospital Employment? 3 Leaders Weigh In
7 Things for Spine Surgeons to Know for Thursday