Health
FDA Approved Artificial Blood Vessel Despite Warnings
When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure whether blood was flowing freely through the high-tech tube 30 days after it was implanted in a person.
As those days passed, some of the 54 patients in the study ran into trouble. 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, Food and Drug Administration records show.
Humacyte, which is traded on the Nasdaq, counted all those patients as proof of success in talks with investors and in an article in JAMA Surgery.
At the F.D.A., though, scientists counted the deaths, amputations and the lost case as failures, records show, noting a lack of information to determine if the vessels were clear.
Still, the agency approved the vessels in December without a public review of the study. Top officials authorized it over the concerns of staff members who said in F.D.A. records that they found the study severely lacking or were alarmed by the dire consequences for patients when the vessels fell apart.
Now the company is ramping up its marketing efforts to hospitals and for use on the battlefield.
When a patient’s blood vessel is damaged, doctors typically find a blood vessel from another part of the body and graft it to repair blood flow. They turn to artificial vessels when patients are too badly injured to harvest a vein.
The Humacyte vessel is made from a mesh tube seeded with cells from the human heart. The cells grow over two months in a bioreactor, and at the end of the process, the human cells and genetic material are removed. A lab-grown tube, mostly made of collagen developed from the aortic cells, remains.
Before the vessel was approved, one F.D.A. medical reviewer pointed out that 37 of the 54 patients were not assessed in a safety check four months after getting the implant, with many dead or lost to follow-up. “There is significant uncertainty regarding the safety and effectiveness of this product beyond 30 days,” the F.D.A. report says.
Dr. Robert E. Lee, a vascular surgeon who cared for gunshot-wounded patients in Detroit for 30 years, retired in the fall from the F.D.A. in protest over the matter. In a review of more than 2,000 pages of company records conducted when he was an F.D.A. medical officer, Dr. Lee found that the vessel could rupture with no warning. Those events were “unpredictable, catastrophic and life-threatening,” he wrote in his F.D.A. review, parts of which were made public weeks ago.
“That’s an unacceptable risk for whatever slim benefit, if any, this product provides above the current standard treatments,” Dr. Lee, who had been a reviewer at the agency since 2015, said in an interview. He noted that doctors currently use the patients’ own vessels, if available, or tubes made of Gore-Tex.
An F.D.A. spokeswoman said the approval “was based on a careful evaluation of data from clinical trials that demonstrated a clinically meaningful benefit in restoring blood flow in the affected limb and ultimately limb salvage.”
Humacyte is also developing a graft for patients with dialysis, for those undergoing cardiac bypass surgery and for infants with a heart-related birth defect.
Dr. Laura Niklason, one of the company’s founders, said approval of the vessel, called Symvess, was a “milestone for regenerative medicine overall.”
She had begun work to create the lab-grown vessels decades earlier. In its 20 years, the company had logged no sales and accrued more than $660 million in debt, financial reports show.
In an interview, Dr. Niklason said the disagreement over how to label the patient deaths and amputations as successes or failures arose after the company decided to count cases as failures only when it was certain that blood flow was cut off. The F.D.A. took a more conservative approach to calculating the success rate for the product, she said. “Rational people can disagree,” she added.
The F.D.A. records do not indicate whether the problems with the vessels directly caused the deaths or amputations.
Dr. Niklason said that the company must use the agency numbers in marketing the product to clients but that it could present its more favorable figure to investment analysts. She also said the study was published before the F.D.A. reached its decision.
B.J. Scheessele, the company’s chief commercial officer, told investors this month that Humacyte was in talks with 26 hospitals to begin distribution. Mr. Scheessele also said the company was hoping to sell the vessels to the Defense Department for battlefield injuries. The U.S. Army gave Humacyte $6.8 million in 2017, embracing the product as an option for wounded soldiers.
Each artificial vessel costs $29,500, and Mr. Scheessele said the company hoped to market several thousand each year in the United States.
Dr. Niklason said in an interview that her interest in engineering a blood vessel was twofold. As a young doctor, she had observed that arterial disease was devastating.
She described an experience as a medical resident in the late 1990s watching a senior doctor make incision after incision in a patient’s legs and arm, seeking a healthy vessel to use in a heart bypass surgery. She called the procedure “barbaric.”
“To provide a new blood vessel for a patient who needs one, we usually have to rob Peter to pay Paul,” she said.
Since Dr. Niklason first began meeting with the F.D.A. in 2015 about starting a trial in humans, the agency repeatedly found fault with the company’s efforts to study the vessel’s use. Its trial involved people suffering major trauma, such as gunshot or car crash injuries, took place in U.S. hospitals and in Israel. The participants had an average age of 30, and half were Black patients.
Humacyte also provided the vessels to doctors treating injured soldiers in Ukraine.
By Nov. 9, 2023, Dr. Niklason described results of the studies to investors on an earnings call in glowing terms. Initially, she said the rate of blood flow through the vessels at 30 days was 90 percent — beating existing products on the market.
And the results in Ukraine were “remarkable,” she said. “We’re proud to be able to help our Ukrainian surgeon colleagues save life and limb in this wartime setting.”
Over the ensuing months, though, reviewers at the F.D.A., including Dr. Lee, would examine the same studies and conclude that they did not look nearly as good.
As a vascular and general surgeon in Detroit, Dr. Lee had decades of experience with victims of gunshots, stabbings, car crashes and other accident victims who might receive such vessels.
He said he was alarmed by the account of a man in Ukraine who began bleeding at the site of his surgical wound eight days after the vessel was implanted. Doctors discovered a two-millimeter hole in the Humacyte vessel and repaired it with sutures, according to F.D.A. records. Four days later, the patient was bleeding again, requiring removal of the graft the next day. The review suggested that an infection could have played a role.
Of 71 cases that Dr. Lee examined for a safety review, seven people, or about 10 percent, experienced vessel failures that resulted in major bleeding, according to the F.D.A. review. Dr. Lee said that was unheard-of in his experience with Gore-Tex grafts.
“Plastic arteries, they don’t usually present with catastrophic hemorrhage, unexpected like this,” Dr. Lee said. “You know the patients are sick,” with a fever or other signs of an infection, he continued. “You know something’s brewing, and you usually have time to take care of it.”
Hoping to glean more information about the root cause of the mid-vessel blowouts — and to be sure doctors were aware of the possibility — Dr. Lee began seeking a public advisory hearing on the device.
Thomas Zhou, a biostatistician in the biologics division of the F.D.A., also flagged concerns from the U.S. arm of the study and the data from Ukraine.
“Neither study met the usual criteria for an adequate and well-controlled trial,” he wrote.
The study of 16 patients treated in Ukraine was retrospective and observational, meaning researchers could look back at a larger pool of data and select the best cases. It showed “limited support of efficacy,” partly because the injuries were “skewed to shrapnel injuries” and not the devastating wounds typically seen on the battlefield, he said.
The U.S. study was “poorly conducted” and underwent “multiple major changes” during the trial, the statistical review said.
The records also show that F.D.A. scientists dismissed as successful the patient deaths and amputations, citing a lack of information or imaging studies.
As a result, the F.D.A. concluded that the vessel’s success rate for that key study was 67 percent, rather than the company’s 84 percent, F.D.A. records show. In comparison, artificial grafts already had blood flow rates of 82 percent, the review said.
The company also reported an 84 percent success rate at 30 days in an article published in November in JAMA Surgery, which is widely read by surgeons. The article stated that the Humacyte vessel “demonstrates improved outcomes” over other artificial vessels.
It also said the Symvess “provides benefits” in “infection resistance.” The F.D.A. review said there was no clinical evidence demonstrating that extra effect.
Dr. Lee failed to persuade top F.D.A. officials to hold a public advisory committee meeting where the study results could be discussed and reviewed by independent experts. The agency decided instead to send records to three external reviewers, who in turn identified failure of the Humacyte vessels “as a serious risk,” but added that “the appropriate patient population” would benefit, according to documents.
In announcing approval of the graft on Dec. 20, Dr. Peter Marks, head of the biologics division, called the vessels “innovative products that offer potentially lifesaving benefits for patients with severe injuries.”
But the product is accompanied by a black box warning — the agency’s most serious — for failures that “can result in life-threatening hemorrhage.” The F.D.A. also is requiring the company to continue reporting safety data.
Dr. Hooman Noorchashm, co-director of the Amy J. Reed Medical Device Safety Collaborative at Northeastern School of Law, said the F.D.A. should not have approved a product that its scientists deemed inferior to existing options.
“If the graft falls apart,” he said, or if it disconnects to where it is attached to the vessel, “it is basically akin to the patient getting shot.”
Dr. Lee said he hoped the F.D.A., with new leadership under the Trump administration, would still hold a public meeting.
“Every surgeon who uses it needs to see the things that I did,” he said.
NEWYou can now listen to Fox News articles!
South Carolina is facing a major measles outbreak, resulting in the quarantine of hundreds of residents.
The South Carolina Department of Health (DPH) reported in a media briefing on Wednesday that the current number of measles cases has reached 111 as part of the current Spartanburg County outbreak.
DPH first reported a measles outbreak in the Upstate region on Oct. 2.
CLICK HERE FOR MORE HEALTH STORIES
The health department confirmed that 254 people are currently in quarantine and 16 are in isolation to prevent further spread.
The health department confirmed that 254 people are currently in quarantine in the upstate region. (Getty Images)
“This significant jump in cases is unfortunate,” a DPH spokesperson commented on the outbreak.
Public exposure was identified at Inman Intermediate School, with 43 of their students in quarantine.
“This significant jump in cases is unfortunate.”
Eight other intermediate and middle schools in the area are also reportedly undergoing quarantine. The DPH said multiple students have had to quarantine twice due to repeat exposure.
“Vaccination continues to be the best way to prevent the disruption that measles is causing to people’s education, to employment and other factors in people’s lives and our communities,” the spokesperson said.
“This significant jump in cases is unfortunate,” a DPH spokesperson commented on the current outbreak. (iStock)
Out of the 111 confirmed cases, 105 were unvaccinated. Receiving a vaccination within 72 hours has been shown to prevent measles infection, the DPH spokesperson noted.
Some cases are related to travel exposure, while others are from an unknown source, suggesting that measles is circulating in the community, the DPH noted.
CLICK HERE TO DOWNLOAD THE FOX NEWS APP
Connecticut has also reported its first measles case in four years, according to the Connecticut Department of Public Health.
The department confirmed on Thursday that an unvaccinated child in Fairfield County, under the age of 10, was diagnosed with measles after recently traveling internationally.
“Vaccination continues to be the best way to prevent the disruption that measles is causing,” a DPH spokesperson said. (iStock)
The child began to show symptoms several days later, including a runny nose, cough, congestion, fever and a rash starting at the head and spreading to the rest of the body.
The Connecticut DPH noted that measles is “highly contagious” and can spread quickly through the air via coughing or sneezing. The CDC has estimated that nine out of 10 unvaccinated individuals who encounter an infected person will develop the measles virus.
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
According to the International Vaccine Access Center, more than 1,800 cases of measles have been reported in 2025, which is the most since the U.S. declared the virus eliminated in 2000. It is also the most cases recorded in three decades.
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
“The single best way to protect your children and yourself from measles is to be vaccinated,” DPH Commissioner Manisha Juthani, M.D., wrote in a statement. “One dose of measles vaccine is about 93% effective, while two doses are about 97% effective.”
NEWYou can now listen to Fox News articles!
A sperm donor whose samples helped conceive nearly 200 children across Europe unknowingly carried a cancer-causing genetic mutation — a hidden risk now tied to multiple childhood illnesses and early deaths.
An investigation led by the BBC and many other public service broadcasters revealed that the donations were made to Denmark’s European Sperm Bank (ESB). Those donations were then used by 67 fertility clinics in 14 countries over a 17-year span.
The donor, who was not identified, was paid to donate as a student beginning in 2005, according to the report.
ROBOTS POWER BREAKTHROUGH IN PREGNANCY RESEARCH, BOOSTING IVF SUCCESS RATES
Although the donor passed the initial health screenings, he had hidden genetic mutations that damaged the TP53 gene, which helps to prevent cancer by repairing DNA damage or trigger the death of cancer cells.
When TP53 is mutated, those protective functions are lost, which can lead to uncontrolled cell division, accumulation of mutations and tumor growth, research has shown.
A sperm donor whose samples helped conceive nearly 200 children across Europe (not pictured) unknowingly carried a cancer-causing genetic mutation — a hidden risk now tied to multiple childhood illnesses and early deaths. (Getty Images)
Up to 20% of the man’s sperm would contain that mutated gene, and any children conceived from that affected sperm would have the mutation in every cell of their body, the BBC report stated.
As a result, these children would have a 90% risk of developing some type of cancer in their lifetime, including breast cancer, bone cancers, brain tumors and leukemia. This heightened risk is known as Li Fraumeni syndrome.
THREE-PERSON IVF TECHNIQUE SHOWN TO PREVENT INHERITED GENETIC DISEASES
Doctors raised these concerns at the annual congress of the European Society of Human Genetics (ESHG), which was held in Milan in May 2025.
At that conference, Edwige Kasper — a specialist in cancer genetics at Rouen University Hospital in France — presented the case of the sperm donor whose genetic material carried the harmful variant.
“This is the abnormal dissemination of genetic disease. Not every man has 75 children across Europe.”
It was reported that 23 children had been confirmed to have the variant at that time, 10 of which had already been diagnosed with cancer.
The actual number is likely much higher, the report surmised, as at least 197 children were born from the donated sperm — but not all data has been collected.
Kasper called for a limit on the number of births or families for a single donor in Europe.
“We can’t do whole-genome sequencing for all sperm donors — I’m not arguing for that,” she said. “But this is the abnormal dissemination of genetic disease. Not every man has 75 children across Europe.”
SKIN DNA BREAKTHROUGH COULD LET 60-YEAR-OLD WOMEN HAVE GENETICALLY RELATED KIDS
She also recommended that children born from this donor’s sperm undergo genetic counseling.
“We have some children that have already developed two different cancers, and some of them have already died at a very early age,” Kasper recently told the investigators.
Up to 20% of the man’s sperm would contain that mutated gene, and any children conceived from that affected sperm would have the mutation in every cell of their body, the BBC report stated. (iStock)
There is no worldwide law that limits how many times a donor’s sperm can be used or how many children may be born from a single donor, according to the European Society of Human Reproduction and Embryology (ESHRE).
However, individual countries may have their own rules or guidelines surrounding sperm donor usage. The ESHRE recently proposed a cap of 50 families per donor as an international limit.
HOW AI IS MAKING IVF MORE PREDICTABLE
Dr. Marc Siegel, Fox News senior medical analyst, commented on these developments to Fox News Digital.
“This awful story emphasizes the growing need for up-to-date genetic screening for all donors,” he said. “It also provides context for the idea that knowing the donor provides an advantage.”
“This awful story emphasizes the growing need for up-to-date genetic screening for all donors,” Dr. Marc Siegel said. (iStock)
“Genetic screening, including for oncogenes (genes that have the potential to cause cancer) is improving dramatically, and all use of sperm donations must include it,” Siegel went on.
He also called for AI to be used to improve and speed up the process.
“When a propensity for disease is suspected, the sperm must be discarded,” the doctor added.
CLICK HERE TO DOWNLOAD THE FOX NEWS APP
In a statement sent to Fox News Digital, the European Sperm Bank expressed “deepest sympathy” for the families involved.
“We are deeply affected by the case and the impact that the rare TP53 mutation has on a number of families, children and the donor. They have our deepest sympathy,” the ESP said.
The American Society of Reproductive Medicine provided its guidance on embryo and gamete donation, which stated in part that all prospective donors should undergo “appropriate genetic evaluation.” (iStock)
“ESB tests and performs an individual medical assessment of all donors in full compliance with recognized and scientific practice and legislation.”
In the case of this particular sperm donor with the TP53 mutation, the ESB noted that it occurs only in a small part of the donor’s sperm cells and not in the rest of the body.
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
“In such cases, the donor himself and his family members are not ill, and a mutation of this type is not detected preventively by genetic screening,” the agency said.
When the ESB later confirmed the mutation in 2023, the donor was “immediately blocked” and authorities and clinics were notified.
“Donors should be healthy and have no history to suggest hereditary disease.”
“The clinics are responsible for informing the patients, partly because we as a sperm bank do not necessarily know the patients, and because the patients’ own treating physicians are best equipped to advise them in the specific situation,” the agency stated.
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
When contacted by Fox News Digital, the American Society of Reproductive Medicine (ASRM) provided its guidance on embryo and gamete donation, which stated in part that all prospective donors should undergo “appropriate genetic evaluation.”
“Donors should be healthy and have no history to suggest hereditary disease,” the ASRM continued.
CLICK HERE FOR MORE HEALTH STORIES
Parents with concerns are encouraged to contact both their treating clinic and the relevant fertility authority in that country.
GLP-1 weight loss pill in development
Fox News senior medical analyst Dr. Marc Siegel discusses advancements in weight loss drugs, safety concerns surrounding nicotine patches and his interview with FDA Commissioner Dr. Marty Makary on vaccine protocol.
NEWYou can now listen to Fox News articles!
Scientists in Sweden have created a new pill designed to help the body burn fat and control blood sugar in a different way than popular GLP-1 drugs, like Ozempic.
While injectable GLP-1s work by suppressing appetite, this new treatment boosts metabolism in the muscles.
A study led by researchers at Karolinska Institutet and Stockholm University included both an early animal study and a human clinical trial with 48 healthy adults and 25 people with type 2 diabetes, according to a press release.
NEW WEIGHT-LOSS SHOT SHOWS MAJOR FAT REDUCTION, BUT EXPERTS URGE CAUTION
The new oral medication was found to successfully control blood glucose, boost fat burning and retain muscle mass in animals, while getting high marks for tolerability and safety in humans.
It was also found to have fewer side effects than GLP-1s like semaglutides and tirzepatides, which are known to cause appetite loss, gastrointestinal distress and muscle wasting, the researchers noted.
While injectable GLP-1s work by suppressing appetite, this new treatment boosts metabolism in the muscles. (iStock)
The experimental medication uses a new form of beta-2 agonist that benefits muscle function while also avoiding overstimulation of the heart, which has been identified as a potential safety concern of older versions.
The findings were published this week in the journal Cell.
WEIGHT-LOSS DRUGS NOW LINKED TO CANCER PROTECTION IN WOMEN, MAJOR NEW STUDY REVEALS
Because the new oral drug acts via a different mechanism than appetite-suppressing medications, it could be used alone or in combination with GLP-1s, the researchers noted.
“Our results point to a future where we can improve metabolic health without losing muscle mass,” said Tore Bengtsson, professor at the Department of Molecular Bioscience at Wenner-Gren Institute, Stockholm University, in the release. “Muscles are important in both type 2 diabetes and obesity, and muscle mass is also directly correlated with life expectancy.”
“Muscles are important in both type 2 diabetes and obesity, and muscle mass is also directly correlated with life expectancy.” (iStock)
This medication has the potential to be of “great importance” for patients with type 2 diabetes and obesity, according to Shane C. Wright, assistant professor at the Department of Physiology and Pharmacology at Karolinska Institutet.
CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER
“Our substance appears to promote healthy weight loss and, in addition, patients do not have to take injections,” he added.
Dr. Trey Wickham, interim chief of the Division of Endocrinology, Diabetes & Metabolism at VCU Health in Richmond, Virginia, was not involved in the study but shared his reaction to the publication in the journal Cell.
“Our results point to a future where we can improve metabolic health without losing muscle mass.”
“This compound’s mechanism of action could address some specific metabolic concerns with previous weight reduction therapies, such as the loss of both muscle and fat tissue,” Wickham told Fox News Digital.
“Although the reported preliminary results are interesting, rigorous testing involving larger longitudinal trials are necessary to ensure human long-term safety and understand the potential role of this compound in the comprehensive, evidence-based treatment of obesity and diabetes.”
CLICK HERE TO DOWNLOAD THE FOX NEWS APP
The study had some limitations, the researchers noted, chiefly that the preclinical studies in mice fail to capture the “complex nature of these diseases” in humans.
Structural studies are needed to understand exactly how the drug works.
“This compound’s mechanism of action could address some specific metabolic concerns with previous weight reduction therapies, such as the loss of both muscle and fat tissue,” a doctor said. (iStock)
“Our phase 1 data show that compound 15 is well-tolerated; however, conclusive clinical efficacy data (on how the drug controls glucose metabolism) are currently still lacking.”
CLICK HERE FOR MORE HEALTH STORIES
Looking ahead, the company that developed the drug, Atrogi AB, plans to conduct a larger phase 2 clinical trial with a larger, more diverse population, including people with obesity.
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
The study was supported in part by the Swedish Research Council, the Swedish Society for Medical Research and the Novo Nordisk Foundation.
Uppsala University, University of Copenhagen, Monash University and University of Queensland all collaborated with the lead researchers.
Trump announces pardon for Tina Peters, increasing pressure to free her though he can’t erase state charges | CNN Politics
Alaska school district erases Veterans Day from official calendar: ‘Absolutely unacceptable’
Expert reveals key factor that led to massive Minnesota fraud scheme
Republicans protest double standard after judges call Texas redistricting plan ‘racially gerrymandered’
Barefoot father and son airlifted from Everglades mudhole after ATV runs out of gas: ‘Alligators are hungry’
Florida High School Football Rankings: Top 25 teams – Oct. 21
Cleary's 21 help Le Moyne down Central Connecticut State 69-64 in OT
How old is Bo Nix? What to know about Oregon quarterback ahead of 2024 NFL Draft
99th annual Pony Swim held in Virginia
Video: ‘It Didn’t Have to Happen This Way:’ U.Va. Faculty Call for Review of Police Response to Protests
Trump announces pardon for Tina Peters, increasing pressure to free her though he can’t erase state charges | CNN Politics
Video: Hiker Rescued From Quicksand in Arches National Park
The Speaker’s Lobby: What Congress’ December script means for healthcare next year
Coalition of the Willing calls for transatlantic unity for Ukraine
In a setback for Trump, Indiana lawmakers defeat redistricting plan
-
Alaska6 days agoHowling Mat-Su winds leave thousands without power
-
Politics1 week agoTrump rips Somali community as federal agents reportedly eye Minnesota enforcement sweep
-
Ohio1 week agoWho do the Ohio State Buckeyes hire as the next offensive coordinator?
-
Texas6 days agoTexas Tech football vs BYU live updates, start time, TV channel for Big 12 title
-
News1 week agoTrump threatens strikes on any country he claims makes drugs for US
-
World1 week agoHonduras election council member accuses colleague of ‘intimidation’
-
Washington3 days agoLIVE UPDATES: Mudslide, road closures across Western Washington
-
Iowa5 days agoMatt Campbell reportedly bringing longtime Iowa State staffer to Penn State as 1st hire