Todd Gillenwater, CHI’s senior vice president of public policy, opened the program by detailing the impact of musculoskeletal disease in the United States. In particular, he noted that in the U.S. alone, these conditions are a leading cause of disability, accounting for more than 130 million patient visits to healthcare providers each year. Further, he said the annual cost of treatment associated with musculoskeletal disease is estimated at a staggering $254 billion.
Then, CHI’s invited panel of experts took the podium in turn to present their own unique perspectives on musculoskeletal health. First to the podium was Dr. Said Ibrahim, professor of medicine and vice chair of the Department of Medicine at the University of Pennsylvania School of Medicine. His presentation focused on health disparity research in the area of joint replacement procedures, which has shown that minorities, African Americans in particular, are less likely than Caucasians to opt for elective joint replacement procedures. His findings, adjusted for key factors such as insurance coverage, indicated that the disparity was related to the fact that African Americans were less familiar with the procedures and more concerned about things like post-operative pain and recovery time. Ibrahim said he believes that this disparity is now well enough understood to be effectively addressed by a targeted educational campaign.
Dr. Deborah Kado, associate professor with the Departments of Orthopedic Surgery and Medicine at the Geffen School of Medicine at UCLA, presented research on hyperkyphosis — a musculoskeletal aging condition that creates humped necks or upper backs in men and women. The condition is now recognized as a geriatric syndrome, yet surprisingly little is known about its causes or potential means of prevention. Preliminary studies, including Kado’s own National Institutes of Health-funded projects, have demonstrated that the condition decreases lung function and quality of life, while increasing rates of falls, injury and mortality. Kado’s team has received renewed NIH funding to continue its work on hyperkyphosis through a 1,800-member cohort study of men over the age of 65.
Next to the podium was Laetitia Cousin, vice president of regulatory and clinical affairs and quality assurance with San Diego-based NuVasive. Cousin discussed NuVasive’s explosive growth led by their innovative, minimally disruptive spinal surgery devices and techniques. NuVasive’s next-generation surgical methods and tools make their procedure’s quality-adjusted life year (QALY) outcomes equal to or better than that of hip surgery, helping to erode spinal surgery’s poor 1990s-era reputation. Cousin closed by laying out two main obstacles to NuVasive’s willingness and ability to reinvest its recent profits in additional R&D and growth: U.S. Food and Drug Administration clearance/approval delays and the medical device excise tax. NuVasive recommended improved FDA transparency through guidance documents; improved FDA reviewer retention and expertise through training; improved FDA review process efficiency through earlier and more frequent collaboration with industry; and repeal of the device tax.
Last to present was Scott Simonet, Ph.D, vice president of research for Amgen. Simonet described the 15-year process to discover and develop Amgen’s denosumab, a drug that regulates bone density and helps the human body limit bone reabsorbtion. With precursor science first discovered in 1995, the product received FDA and European regulatory approval to treat osteoporosis in 2010, as well as FDA approval for cancer-related indications in the same year. While Simonet was sparing in his willingness to express complaints associated with denosumab’s approval process, he did make a point to show the length and complexity of the product’s discovery and development chain.
The presentations spurred a lively and candid follow-on discussion between the panelists and the audience. As the event closed, many expressed their thanks to CHI for organizing the session, with more than one attendee saying that that they had found it “very educational.”
CHI-Advancing California biomedical research and innovation
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