In November 2019, AAOS announced the launch of its strategic investment in the field of biologics. Over the next five years, AAOS will prioritize research and development for a biologics-focused competency within the Academy’s existing member benefits, with a focus on creating evidence-based, unbiased information to help shape and guide orthopaedic surgeons who can then educate their patients on this topic.
Biologics is a rapidly evolving field and has significant implications for patients and surgeons. Currently, there are limited sources of reliable and unbiased information, guidelines, position statements, and educational information. Patients sometimes receive substandard care from nonorthopaedic professionals, which may delay orthopaedic treatment and even lead to serious adverse events. For orthopaedic surgeons, such treatments create competitive risk and ethical dilemmas, as more rigorous, evidence-based surgeons may lose patients to less scrupulous professionals willing to perform unproven treatments to fulfill any patient request or actively shift market share.
“It’s a very interesting and timely initiative that was created after [AAOS observed] that there were many of these stem cell clinics popping up throughout the country, and nobody was really regulating them,” said Philipp Leucht, MD, FAAOS, member of the AAOS Committee on Biologics and Regenerative Medicine. “It is important for orthopaedic surgeons to have a unified voice and come together to put out a statement and platform for people to learn about stem cell and biologics use in orthopaedic conditions.”
The possibilities of biologics in musculoskeletal care are exciting, but AAOS wants to ensure patient safety by identifying safe and effective options and addressing concerns stemming from misinformation in direct-to-consumer advertising. The Academy seeks to unify biologics-related treatments across bone and joint healthcare professionals, including orthopaedic surgeons, physiotherapists, physical therapists, orthopaedic nurses, and other musculoskeletal professionals.
The rationale for this investment was borne out of a 2018 symposium, during which participants relayed a large gap in knowledge and evidence regarding biologics treatments for musculoskeletal diseases and conditions. The Academy’s goal is to fill knowledge gaps with evidence reviews and education for patients and members to ensure all stakeholders have the same context of the current landscape.
“The evidence-based recommendations for biologics, especially for stem cell therapy, are scarce,” Dr. Leucht said. “There’s not a lot of good research out there that allows us to give patients good information on whether biologics will help with their conditions.” He added that AAOS members should care about this initiative: “We want to treat our patients with evidence-based treatments that result in positive outcomes. With the current lack of evidence in this space, we really need to educate our members on what’s safe and what has been proven to benefit our patients.”
The investment and plan
“Biologics are a growing proportion of orthopaedic care, and over the next 10 to 20 years, they will be even bigger,” Dr. Leucht said. “If we miss this crucial opportunity to lead the initiation of biologics use in musculoskeletal care, then we are going to be behind for the next few decades.”
Following a merger of the Committee on Biologics and Regenerative Medicine and the Biomedical Engineering Committee, the newly formed Committee on Devices, Biologics, and Technology will report up through the Council on Research and Quality; oversee all Academy biologics initiatives; and include a chair, eight members-at-large, and outside consultants.
Over the next five years, the Academy will invest at least $1.25 million in this initiative to support the prioritization and execution of key activities to develop and deliver a biologics-focused portfolio within the Academy’s existing business.
With the Academy’s trusted, rigorous process for reviewing evidence with methodology that is transparent and replicable, AAOS is in a prime position to be a leader in the scientific research of biologics. Key activities of the initiative will include symposia, evidence-based systematic reviews, white papers and consensus statements, and other educational content.
The Academy will soon launch a biologics webpage on the AAOS website, which will house educational resources for physicians and patients, including Academy-created white papers, position statements, clinical practice guidelines, and more. The AAOS Office of Government Relations will also be involved in working to effect change from a regulatory and legislative standpoint.
“I want to see this initiative become the prime voice for all musculoskeletal biologics use. When physicians want to learn about biologics use, they should visit AAOS’ biologic programming materials online and look to our educational and research portfolio to see what evidence is out there to treat patients appropriately with biologics,” concluded Dr. Leucht.
The Academy will roll out more information on its biologics initiative in the coming months and during the AAOS 2020 Annual Meeting.
Kerri Fitzgerald is the managing editor of AAOS Now. She can be reached at email@example.com.