Noorchashm Calls Upon JAMA for Retraction to Protect Critically Injured American Service Members and Others at Risk from A Controversial, New and Non-Standard Vascular Bypass Device
08.30.25 —Dr. Hooman Noorchashm, an internationally recognized medical device safety expert and research professor at Northeastern Law, is calling upon JAMA Surgery to retract an article related to the safety and efficacy of the Symvess biologic vascular graft. While JAMA Surgery did issue “corrections and clarifications … to the Original Investigation titled ‘Bioengineered Human Arteries for the Repair of Vascular Injuries,’ published online on November 24, 2024, and in the February 2025 issue of JAMA Surgery,” Noorchashm argues that a full retraction must take place given that the authors have explicitly admitted to doctoring their “unconventional clinical data set” in a way that avoided showing the potential “attenuated” safety and efficacy profile of this new and non-standard vascular bypass device.
In a letter to Dr. Melina Kibbe, editor-in-chief of JAMA Surgery, Noorchashm states, “The magnitude of your editorial error is accentuated by the fact that this non-standard device is now primarily marketed to the United States military for use in critically injured American warfighters, who do not even have a chance to consent to being treated with this new and non-standard device, whose safety, efficacy and non-inferiority are unproven or controversial.” Noorchashm explicitly states that, “the FDA commissioner and the Secretary of Health and Human Services, ought not allow American soldiers to be used as guinea pigs to satisfy the demands of corporate profiteers in the US biotech sector.”
Noorchashm, who serves as co-director of the Amy J. Reed Medical Device Safety Collaborative, a joint initiative between Northeastern Law and Tufts University, is a nationally recognized expert on medical device safety. He and Reed Collaborative co-director Professor David Simon have submitted a formal petition to the FDA requesting the safety and non-inferiority data be subjected to a stringent public expert committee review and call for revoking the Symvess approval until such time as non-inferiority to the current standard of care is incontrovertibly established.
The New York Times has also reported on significant concerning irregularities with the integrity of the review and approval process at FDA as has Northeastern Global News.
“JAMA Surgery’s editorial failure to retract a paper whose dataset seems to have been deliberately altered to provide the false impression of safety and non-inferiority to the current standards of care in vascular bypass, is in a league of its own,” Noorchashm wrote to Kibbe.
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