A medical device created by Humacyte Global faces internal resistance from scientists within the FDA, who questioned the product’s safety and fitness for market.
In December, the Food and Drug Administration approved the first-of-its-kind artificial blood vessel to be used primarily in urgent, life-or-death scenarios involving traumatic injuries, such as those incurred during war.
But the medical device — a so-called “biologic” created by Humacyte Global — faced internal resistance from scientists within the FDA who questioned the product’s safety and fitness for market.
Now, a group of Northeastern University legal and medical researchers has formally petitioned the FDA to revoke approval of the device, citing “deficient clinical trial data” that flew in the face of testimony from the agency’s own expert scientists.
“It seemed like there were some significant irregularities with respect to clinical trial endpoints and overall outcomes, in addition to the concerns that folks at the FDA have raised,” says Hooman Noorchashm, a research professor in Northeastern’s School of Law.
Noorchashm serves as co-director of the Amy J. Reed Medical Device Safety Collaborative, a new multi-university partnership that aims to scrutinize the safety risks of new medical devices. The group is devoted to finding examples of regulatory product safety failure, with the goal of analyzing these failures and understanding the regulatory processes that led to them, Noorchashm says.
“Sometimes these investigations morph into citizen petitions, product liability lawsuits or false claims lawsuits,” Noorchashm tells Northeastern Global News.
Greenlit by the Center for Biologics Evaluation and Research (CBER), Humacyte’s device, called Symvess, is “a sterile, acellular tissue engineered vessel” made of proteins found in human blood vessels. Despite noting a number of adverse reactions, the CBER’s review committee recommended approval, adding that the “benefits outweighed the risks.”
As current therapies for vascular trauma are limited, FDA officials touted the biologic as “important progress in addressing a significant unmet medical need.”
But Noorchashm and his colleagues are seeking more information about how and why the device was approved despite red flags.
“This product was categorized as a biologic, which means it likely will have a more rigorous review than a device would ordinarily get,” says David Simon, an associate professor of law whose expertise is intellectual property, health care law, data and liability.
“It’s less about whether the company has to show that its product is more safe and effective than an existing therapy but rather, in this case, the fact that there are people saying this device doesn’t even meet the existing standard given the catastrophic risks associated with it,” Simon says.
A report in the New York Times detailing internal objections to the approval notes several patients who took part in a study had complications after the device was implanted in an extremity. “Doctors lost track of one. Four died. Four more had a limb amputated, including one who developed a clot and infection in the artificial vessel,” according to the Times.
A whistleblower with the FDA, Dr. Robert E. Lee, a vascular surgeon who specializes in caring for patients with gunshot wounds, retired last year in protest over the device’s approval, according to the Times. Another medical reviewer with the FDA wrote that the two studies submitted by the company didn’t meet “the usual criteria for an adequate and well-controlled trial.”
In addition to asking that the product’s approval be revoked, Noorchashm and Simon are petitioning the FDA to initiate a “stringent public expert committee review” into the device’s safety data. The secretary of Health and Human Services can convene an open advisory committee hearing, where independent experts and other stakeholders can weigh in on product approval and safety.
Additionally, they are asking that the FDA recall the product and share any internal data submitted by Humacyte with the Department of Defense, which has partnered with the FDA to purchase the device to treat wounded military personnel.
In a statement responding to the citizen petition, Humacyte President and CEO Dr. Laura Niklason noted that Lee left the FDA to found a separate company — one she described as a “potential competitor” in providing “vascular access for hemodialysis.”
“Over the last two decades, we’ve worked hard to build Humacyte into what it is today,” Niklason said. “I take immense pride in that work, and I won’t let false, harmful claims go unchallenged.”
Niklason added that the company “will respond at the appropriate time with the FDA.”
The development of biologics for vascular injuries — particularly acute injuries, such as those suffered on the battlefield — provide alternative solutions to grafting procedures whereby surgeons harvest healthy vessels from other parts of the body to bypass a blocked or injured artery. Vascular grafting is currently the gold standard of care in those acute cases, but also as it pertains to patients who’ve suffered heart attacks or other cardiac issues.
The current alternative to vascular bypass, especially in the trauma setting, is the use of artificial vascular conduits made of dacron or GoreTex, Noorchashm says. These devices are time-tested, he says, and are widely used in hospitals today.
“So Humacyte’s new device is aiming to replace them by claiming superiority of outcomes,” he adds. “The problem is if you jump the gun and force something into the marketplace that isn’t safe and effective — or at the very least non-inferior to the existing standard of care — then you risk doing unjustified harm and creating liability for the company and its investors.”
The careful vetting of new therapies, such as the vascular conduit created by Humacyte, is especially vital because such devices are typically used as a lifesaving measure in situations where patient consent is not always possible, Noorchashm says.
“As it stands, the use of this device represents a non-standard approach to care,” Noorchashm says. “If a patient is harmed, in the civil context — not the military context — they could actually bring a medical malpractice lawsuit for breach of standard.”
“One purpose of the collaborative is to catch these devices early in their life cycle before they do harm,” Noorchashm adds.
Under the FDA’s accelerated approval regime, potentially lifesaving drugs and devices can get through the agency’s procedural hoops much faster than the process would otherwise dictate. The accelerated approval standard lets federal regulators approve drugs or devices on the basis of “surrogate endpoints” rather than direct evidence of how patients respond to therapies.
Simon notes that, as it pertains to medical devices and biologics, that has often led to the agency authorizing products without sufficient evidence to indicate clinical benefit.
“You’ve seen a lot of criticism of the FDA for not requiring the kind of safety and efficacy data we really should require in other contexts, such as accelerated approval of drugs,” he says. “In the device space, which is what we’re primarily focused on, it’s a mess. The level of evidence for most of the devices that come on the market is weak or nonexistent.”