Health

FDA Approved Artificial Blood Vessel Despite Warnings

Published

8 months ago

March 24, 2025

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.

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Health

Alzheimer’s risk declines sharply with one daily lifestyle change, researchers say

Published

6 hours ago

November 28, 2025

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Alzheimer’s risk declines sharply with one daily lifestyle change, researchers say

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Increasing physical activity in midlife or later may reduce the chances of developing dementia by up to 45%, according to a recent study published in JAMA Network Open.

Researchers at the Boston University School of Public Health analyzed data from more than 4,300 people in the Framingham Heart Study Offspring, all of whom were dementia-free at the start of the study.

The individuals completed a questionnaire reporting their amount of sleep and level of physical activity (sedentary, slight, moderate or heavy), according to the study report.

DEMENTIA RISK COULD BE LINKED TO WALKING SPEED, STUDY SUGGESTS

Study design and key findings

The researchers analyzed the individuals’ physical activity throughout three life stages — early adult (ages 26-44 years), midlife (45-64 years) and late life (65-88 years).

Increasing physical activity in midlife or later may reduce the chances of developing dementia by up to 45%, according to a recent study published in JAMA Network Open. (iStock)

They followed the participants for an average span of 37.2, 25.9 and 14.5 years, respectively, to monitor the onset of Alzheimer’s and other types of dementia.

Those in the top two quintiles of midlife physical activity were associated with a 40% lower all-cause dementia risk over a 26-year period, compared to those with the lowest activity level.

RATES OF DEMENTIA ARE LOWER IN PEOPLE WHO EAT THIS SPECIFIC DIET, RESEARCH SHOWS

People in the top two quintiles of late-life physical activity were associated with a 36% to 45% lower dementia risk over 15 years.

Thise with the highest midlife physical activity were associated with a 40% lower all-cause dementia risk over a 26-year period, compared to those with the lowest activity level. (iStock)

“These results may help to inform more precise and effective strategies to prevent or delay the onset of dementia in later life, and support evidence that the benefits of physical activity on the brain may extend to earlier in life than previously thought,” study author Phillip Hwang, Ph.D., from the Department of Epidemiology at the Boston University School of Public Health, told Fox News Digital.

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Higher activity in midlife was associated with lower dementia risk only in people without APOE4, a genetic variant linked to higher Alzheimer’s risk.

However, this was not the case with the late-life higher activity group, which showed reduced dementia risk among both APOE4 carriers and those without the gene, according to the study.

The exercise-brain link

“There are several possible mechanisms through which physical activity is thought to lower the risk of dementia, such as improving brain structure and function, reducing inflammation and exerting benefits on vascular function,” Hwang told Fox News Digital.

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Physical activity may also directly impact Alzheimer’s disease pathology, such as the buildup of toxic beta-amyloid in the brain, according to the researcher.

Physical activity may also directly impact Alzheimer’s disease pathology, such as the buildup of toxic beta-amyloid in the brain. (iStock)

“These potential mechanisms may contribute to facilitating cognitive reserve, which can delay late-life cognitive impairment.”

More research is needed to understand whether these possible causes all happen at the same time throughout a person’s life, or if different causes emerge at different stages, the researchers said.

Expert reactions

Dr. Cathryn Devons, M.D., who specializes in geriatric medicine at Phelps Hospital Northwell Health in Sleepy Hollow, New York, was not part of the study but commented on the findings.

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Exercise can lower the risk of hypertension, stroke, vascular disease, cholesterol levels and diabetes — “all the things that put you at risk for circulatory problems to the brain,” she told Fox News Digital.

The doctor also noted that exercise is known to help to reduce inflammation, which can protect brain health.

Study limitations

One limitation of the study is that physical activity was based on self-reporting, Hwang told Fox News Digital.

Physical activity may also directly impact Alzheimer’s disease pathology, such as the buildup of toxic beta-amyloid in the brain. (AP Photo/Evan Vucci, File)

“While we can say from these results that higher levels of overall physical activity are associated with reduced dementia risk, these results cannot translate well to recommendations about specific exercise types,” he said.

Also, the level of physical activity in early adulthood was not linked with all-cause dementia or Alzheimer’s dementia.

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“We may have been underpowered to detect associations with early adult life physical activity due to the small number of dementia cases in this age group,” the authors noted.

Devons agreed that while the study may have limitations, it supports the idea of exercise lowering the risk of dementia.

Amy McGorry is a contributing health writer for Fox News Digital. Follow her on Twitter @amymcgorry.

Health

Stop heartburn before it starts: 5 dinner mistakes to avoid, from a GI doctor

Published

1 day ago

November 27, 2025

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Stop heartburn before it starts: 5 dinner mistakes to avoid, from a GI doctor

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The holidays are a time for family, food and festive cheer — but for many people, they also bring an unwelcome guest: heartburn.

It’s no coincidence that cases of reflux spike this time of year, according to Dr. Mark Shachner, medical director of the Broward Health Coral Springs Heartburn Center in South Florida.

“Heartburn tends to flare up during the holidays because we often eat larger portions, enjoy richer foods, and indulge in more sweets and alcohol than usual,” he told Fox News Digital.

HEART SURGEON REVEALS WHAT TO EAT (AND NOT EAT) FOR OPTIMAL CARDIAC HEALTH

Combine those rich holiday foods and drinks with overeating, late-night meals, and lying down too soon after eating, and you’ve got what the doctor calls “a recipe for reflux.”

“Heartburn tends to flare up during the holidays because we often eat larger portions, enjoy richer foods, and indulge in more sweets and alcohol than usual.” (iStock)

Below, the doctor shares five common mistakes people make that can trigger heartburn — during the holidays and year-round.

1. Eating too much and too fast

Shachner recommends eating smaller portions, chewing slower and resisting the urge to go back for seconds until you’ve had time to digest.

GUT IMBALANCE MAY BE DRIVING AMERICA’S FOOD ALLERGY EPIDEMIC, EXPERTS WARN

Staying upright for at least two to three hours after eating helps the stomach empty more efficiently — and keeps acid where it belongs.

“Moderation and timing make the biggest difference,” Shachner added.

2. Indulging in late-night snacks

It’s tempting to grab one last cookie or slice of pie before bed, but Shachner recommends allowing two to three hours between your last bite and bedtime.

Going to bed too soon after eating is one of the biggest culprits for reflux, since lying flat makes it easier for stomach acid to creep upward, he said.

Portion control is key to not only maintaining a healthy weight, but also preventing heartburn. (iStock)

3. Not moving after meals

Walking or other low-effort activities after a big meal can make all the difference, according to Shachner.

“A gentle walk after meals helps digestion and reduces reflux,” he said.

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Even light activity helps the stomach process food and reduces the pressure that leads to heartburn. No matter how appealing it may seem, Shachner recommends avoiding the post-feast nap.

4. Not knowing your triggers

Some foods and drinks are more likely to cause trouble. Common triggers include fatty or fried dishes, tomato sauces, citrus, chocolate, peppermint, alcohol, coffee and carbonated drinks, according to the doctor.

“Everyone’s triggers are a little different, so paying attention to which foods cause discomfort is important,” he added.

Staying upright for at least two to three hours after eating helps the stomach empty more efficiently and prevents acid reflux. (iStock)

5. Ignoring symptoms

An occasional bout of heartburn isn’t usually cause for concern, but if you’re having symptoms two or more times a week, or if over-the-counter remedies stop working, the doctor said it’s important to pay attention.

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“That’s when it’s time to see a doctor for a full evaluation,” he said.

Chronic reflux can signal gastroesophageal reflux disease (GERD), which can cause long-term damage if left untreated.

Frequent heartburn can signal something more serious, but it’s often treatable. (iStock)

The doctor also cautioned about relying too heavily on antacids or acid reducers. “It’s best to use them under the guidance of a healthcare professional who can identify and treat the root cause rather than just the symptoms,” he advised.

Advanced relief options

For people with chronic reflux, there are now minimally invasive, FDA-approved treatments that provide lasting relief without traditional surgery.

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“One example is the LINX® procedure, which uses a small ring of magnetic beads to reinforce the lower esophageal sphincter,” Shachner shared.

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Another is transoral incisionless fundoplication (TIF), which restores the natural barrier between the stomach and esophagus through the mouth, with no external incisions.

Khloe Quill is a lifestyle production assistant with Fox News Digital. She and the lifestyle team cover a range of story topics including food and drink, travel, and health.

Health

Judge rules West Virginia parents can use religious beliefs to opt out of school vaccine requirements

Published

2 days ago

November 26, 2025

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Judge rules West Virginia parents can use religious beliefs to opt out of school vaccine requirements

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A West Virginia judge ruled on Wednesday that parents can use religious beliefs to opt out of school vaccine requirements for their children.

Raleigh County Circuit Judge Michael Froble on Wednesday issued a permanent injunction, saying children of families who object to the state’s compulsory vaccination law on religious grounds will be permitted to attend school and participate in extracurricular sports.

Froble found that a state policy prohibiting parents from seeking religious exemptions violates the Equal Protection for Religion Act signed into law in 2023 by then-Gov. Jim Justice.

West Virginia was among just a handful of states to offer only medical exemptions from school vaccinations when Gov. Patrick Morrisey issued an executive order earlier this year allowing religious exemptions.

ALABAMA, KANSAS TOP LIST OF MOST ‘FAITH-FRIENDLY’ STATES; MICHIGAN, WASHINGTON RANK LOWEST: REPORT

West Virginia Gov. Patrick Morrisey said that the ruling “is a win for every family forced from school over their faith.” (Andrew Harnik/Getty Images)

However, the state Board of Education voted in June to instruct public schools to ignore the governor’s order and follow long-standing school vaccine requirements outlined in state law.

The board said following Wednesday’s ruling that it “hereby suspends the policy on compulsory vaccination requirements” pending an appeal before the state Supreme Court.

Morrisey said in a statement that the ruling “is a win for every family forced from school over their faith.”

Two groups had sued to stop Morrisey’s order, arguing that the legislature has the authority to make these decisions instead of the governor.

Legislation that would have allowed the religious exemptions was approved by the state Senate and rejected by the House of Delegates earlier this year.

The judge found that a state policy prohibiting parents from seeking religious exemptions violates the Equal Protection for Religion Act signed into law in 2023. (Julian Stratenschulte/dpa (Photo by Julian Stratenschulte/picture alliance via Getty Images))

The judge ruled that the failure to pass the legislation did not determine the application of the 2023 law. He rejected the defendants’ argument that religious exemptions can only be established by legislative moves.

“Legislative intent is not absolute nor controlling in interpreting a statute or determining its application; at most, it is a factor,” Froble said.

A group of parents had sued the state and local boards of education and the Raleigh County schools superintendent. One parent had obtained a religious exemption to the vaccine mandate from the state health department and enrolled her child in elementary school for the current school year before receiving an email in June from the local school superintendent rescinding the certificate, according to the lawsuit.

In July, Froble issued a preliminary injunction allowing the children of the three plaintiffs’ families in Raleigh County to attend school this year.

FEDERAL JUDGE RULES PUBLIC CHARTER SCHOOL VIOLATED CHURCH’S FIRST AMENDMENT RIGHTS

State law requires children to receive vaccines for chickenpox, hepatitis B, measles, meningitis, mumps, diphtheria, polio, rubella, tetanus and whooping cough before attending school. (iStock)

Last month, Froble certified the case as a class action involving 570 families who had received religious exemptions in other parts of the state. He said the class action also applies to parents who seek religious exemptions in the future.

Froble said the total number of exemptions so far involved a small portion of the statewide student population and “would not meaningfully reduce vaccination rates or increase health risks.”

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State law requires children to receive vaccines for chickenpox, hepatitis B, measles, meningitis, mumps, diphtheria, polio, rubella, tetanus and whooping cough before attending school.

At least 30 states have religious freedom laws. The laws are modeled after the federal Religious Freedom Restoration Act, which was signed into law in 1993 by then-President Bill Clinton, allowing federal regulations that interfere with religious beliefs to be challenged.

The Associated Press contributed to this report.