A former FDA medical officer alleges that the agency’s Center for Biologics Evaluation and Research approved a new medical product despite objections from four expert vascular surgeons. The product, Symvess, was approved in December 2024 without being referred to the advisory committee, despite concerns raised by internal and external evaluators. The FDA press officer stated that input from the former officer was considered, but the product was ultimately approved due to its potential life-saving benefits. However, the former officer and FDA Statistical Reviewer Thomas Zhou raised concerns about the quality of the clinical data and the risk of catastrophic failure associated with Symvess. Despite these concerns, the product was approved without a public advisory panel review, leading to allegations that the FDA ignored its policies and relied on problematic data in the approval process. During my time as an FDA medical officer, I always kept the Hippocratic Oath in mind,” Lee said. He expressed concerns about the risks associated with Symvess blowouts and infections, stating that the current treatment options such as using healthy vessels or Dacron grafts are more favorable. Lee emphasized that the risk-benefit balance of using Symvess for vascular trauma is highly unfavorable and that he cannot support exposing individuals, especially military personnel, to such risks.
Acellular Tissue Engineered Vessels like Symvess were given priority designation by the Department of Defense for treating vascular trauma in 2024. However, Lee believes that Symvess is not the solution, as the data does not support its safety and effectiveness in trauma settings. He raised concerns that Symvess could result in worse outcomes compared to other available options.
The pressure for speedy FDA approval may have increased due to the Department of Defense designation, but Lee argued that the data does not confirm Symvess’ durability and infection resistance as hoped. He doubted that military surgeons would be enthusiastic about using Symvess in distant battlefields if they reviewed the detailed data he evaluated.
Humacyte describes Symvess as a milestone for regenerative medicine, designed to resemble the body’s natural vasculature and restore damaged vascular tissue. Made from human donor blood vessel cells, Symvess is a tubular product grown in the laboratory, with all human DNA removed. It can be cut to length for single-patient use in the operating room and has a shelf life of 18 months if refrigerated properly.
Symvess aims to reduce amputation rates for traumatic vascular injuries and eliminate the need to harvest and transplant veins from other areas of the body. Lee acknowledged that Humacyte provided the clinical data requested by the FDA for the trauma indication. However, he criticized the FDA’s vetting process for the data, alleging that it was less than transparent and bypassed input from the Center for Devices and advisory panels.
Lee’s attorney, Dr. Joe Piacentile, expressed optimism that Secretary of Health and Human Services Robert Kennedy Jr., FDA Commissioner Dr. Marty Makary, and Secretary of Defense Pete Hegseth would reconsider the approval of Symvess in light of Lee’s revelations.
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