Date & Time
In the third program in the series on Meeting the Challenge of Conflicts of Interest, we engaged in a wide-ranging discussion to identify best practices as well as creative new strategies to reap the benefits of academic-industry collaborations without incurring the real and perceived costs associate with financial conflicts of interest. Dr. Charles Burton, President Elect of the Association for Medical Ethics, and Dr. Thomas Kipps of UC San Diego explored the best practices and possible new approaches.
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Charles Burton, MD, is a renowned neurosurgical spine specialist, ethicist and educator dedicated to public advocacy for the patient’s best interest. For more than 40 years, he has been on the forefront of neurosurgical spine care innovating devices and practices to improve rehabilitation, preventative care and quality of life for patients with spinal disorders and disease. As the editor of website www.burtonreport.com, he has brought more than 40 years of experience in the medical profession to spearhead his efforts to be a public watchdog focused on increasing the quality of healthcare while decreasing the cost for the patient.
As a neurosurgeon and associate professor, he has taught neurosurgery at Johns Hopkins Hospital in Baltimore and Temple University Health Sciences Center in Philadelphia. Dr. Burton moved to Minneapolis to found the Department of Neuroaugmentive Surgery at Sister Kenny Institute in Minneapolis at the request of Loren Leslie, M.D. and Earl Bakken, the founder of Medtronic, among others, to initiate this innovative effort highlighting the then new discipline of implanting electronic devices designed to augment function of the nervous system as an adjunct to patient rehabilitation. At this facility, most of the patients referred had failed back surgery thus providing insight into the reasons why back surgery was failing patients. His findings initiated numerous research studies and publications intended to improve better patient treatment while also decreasing the incidence of failed back surgery in patients while increasing preventative care and health maintenance.
Dr. Burton has represented organized neurosurgery in the drug and device area and has been Chairman of a Food and Drug Administration medical device advisory panel. It was then he became aware of the need for knowledgeable advisory panel members and the importance of “sunshine” disclosure as important means of negating a potential conflict of interest. He went on to create the Low Back Clinic of the Sister Kenny Institute, the Institute for Low Back Care, the Center for Restorative Spine Care and Sentinel Medical Associates. Dr. Burton was also one of the original founders and a member of Board of Directors of the North American Spine Society (NASS) and the American Board of Spine Surgery as well as being one of the initial members of the International Society for Study of the Spine.
Dr. Burton received his undergraduate degree from Johns Hopkins University in Baltimore and his medical degree from New York Medical College. He completed his Surgical Internship at Yale Medical Center in New Haven and his Neurosurgery Residency at Johns Hopkins Hospital in Baltimore following which he was the head of a neurosurgical unit during the Vietnamese War.
Thomas Kipps, MD, PhD, is Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research, and Deputy Director of Research Operations at the Moores Cancer Center. A major focus of his laboratory group is the immunobiology and genetics of human B-cell malignancies, with emphasis on chronic lymphocytic leukemia (CLL). Study on CLL cells serially collected from patients at time points before therapy, during therapy, or after relapse from therapy allows for investigation of the genetic and biologic features associated with tumor progression, therapeutic response, or resistance to therapy. Discovery of features that distinguish CLL from their normal cell counterparts has helped identify new targets for therapy and/or define surrogate markers associated with more rapid rates of cancer progression or resistance to standard therapy. These studies are integrated with a clinical investigative program that attracts patients seeking improved modalities of treatment for CLL. From this, we have identified molecular markers that can segregate patients into subgroups that have different risks for disease-progression or different probabilities of response to conventional treatment. This also has allowed for testing the safety and relative efficacy of novel agents developed for treatment of all patients with CLL or subgroups of patients hypothesized to have the best potential response to novel forms of therapy. Because CLL cells can be harvested from the blood, it is possible to study primary tumor cells obtained from patients during the course of therapy. This allows for testing whether novel targeted therapies are hitting their intended target and whether this is associated with a clinical response to therapy. To further these efforts on a national scale, Dr. Kipps has organized and leads the CLL Research Consortium that is comprised of leading CLL investigators at the major cancer centers across the country and abroad.
American Association of University Professors (2012): AAUP Recommended Principles & Practices to Guide Academy-Industry Relationships.
This report highlights a variety of concerns with academic industry collaborations and concludes with numerous recommendations.
Association of American Medical Colleges [AAMC] (2012): Implementing the Final Rule on Financial Conflicts of Interest in Public Health Funded Research.
“The goal of this report is to provide institutions subject to the new rule with some insight into how their peer institutions were thinking about these issues in the first few months after announcement of the new rule, and to provide a range of contemplated approaches.”
Institute of Medicine (2009): Conflict of Interest in Medical Research, Education, and Practice.
“This Institute of Medicine report examines conflicts of interest in medical research, education, and practice and in the development of clinical practice guidelines. It reviews the available evidence on the extent of industry relationships with physicians and researchers and their consequences, and it describes current policies intended to identify, limit, or manage conflicts of interest. Although this report builds on the analyses and recommendations of other groups, it differs from other reports in its focus on conflicts of interest across the spectrum of medicine and its identification of overarching principles for assessing both conflicts of interest and conflict of interest policies. The report, which offers 16 specific recommendations, has several broad messages.”
Pfizer (2009): Academia and Industry.
“This brochure illustrates how collaborations between academic institutions and pharma companies can result in actions that benefit patients. It is not meant to convince you that one group or the other is always right, but rather to discuss the issues and demonstrate, through case histories, how interdependent we are.”
Pharmaceutical Research and Manufacturers of America [PhRMA] (2009): Code on Interactions with Healthcare Professionals.
PhRMA, which represents pharmaceutical and biotechnology companies, first introduced this voluntary code in 2002 to guide relationships between industry and healthcare professionals.