Health
Progress for paralyzed patients: First implanted device is placed to restore arm, hand and finger movement
For the first time ever, a human has successfully received an implanted device to enable movement of the arms, hands and fingers after a paralyzing spinal cord injury.
Onward Medical NV, a medical technology company based in the Netherlands, announced on Wednesday the surgical implant of its ARC-IM Stimulator, which is designed to restore function to the upper extremities of paralyzed patients.
The patient, a 46-year-old man, suffered a spinal cord injury nearly two years ago, which left his left side almost fully paralyzed, doctors told Fox News Digital.
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The ARC-IM implantation took place on Aug. 14 at Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland.
During the procedure, the surgeon, Switzerland-based Dr. Jocelyne Bloch, placed electrodes over the man’s cervical spinal cord.
“There are a total of 32 electrodes that are linked to two different pacemakers,” she told Fox News Digital in an interview. “There are two neurostimulators that are able to produce electricity and give impulses to the spinal cord to activate the muscles of the arm.”
Nine days later, in a follow-up procedure, a wireless brain-computer interface (BCI) was implanted.
“We did a very small craniotomy, which means we removed a bit of bone and replaced it with 64 electrodes,” Bloch said.
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Working in tandem with the stimulator, the BCI uses artificial intelligence to connect the brain and spinal cord, the company stated in a press release — essentially capturing the intentions of the paralyzed person, “decoding” those thoughts and then stimulating the spinal cord to convert them into actions.
The successful surgery has been 20 years in the making, noted Professor Grégoire Courtine, co-director of NeuroRestore, a Switzerland-based research, innovation and treatment center that coordinates neurosurgical interventions to restore neurological functions.
NeuroRestore has worked in partnership with Onward throughout this study.
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“When you want to move part of your body, the brain has to send a command to that region to activate the muscles,” Courtine told Fox News Digital in an interview. “When there’s a spinal cord injury, this communication is interrupted. The consequence is paralysis of the limbs.”
With this implant surgery, Courtine said, “We are establishing this communication with a digital bridge that turns thoughts into actions.”
The procedures both went smoothly, the doctors agreed.
Although it’s still too early to provide full results, Bloch said the technology works as expected and appears to “successfully reanimate the patient’s paralyzed arms, hands and fingers.”
“It’s a gradual thing,” she noted. “It’s too early to tell how long it will take — we will be much more knowledgeable in a few months. But it’s not instant — it requires some training.”
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Courtine is optimistic, as he said the devices are “fulfilling expectations” and the stimulation “works very effectively.”
This news comes just a few months after Onward’s May announcement that its ARC-IM and BCI implant had enabled a patient to gain “augmented control” over movement of his paralyzed legs.
“It worked for walking, and so we decided to apply exactly the same technology for hand movement,” Bloch said.
In the coming months, Onward expects to share more information about the surgery and the results in a peer-reviewed publication.
“At this stage, the technology is very experimental,” Courtine noted.
Years of large-scale clinical trials will need to be completed — and most likely, it won’t be until the end of the decade when this technology is widely available, he said.
“As the unit will possess learning capacity, the patient’s brain will also ‘learn’ to use the device to its fullest capacity.”
Every year, around the world, between 250,000 and 500,000 people suffer a spinal cord injury, according to the World Health Organization (WHO).
Most of these are due to trauma during which a segment of the spinal cord is injured or severed, resulting in neurologic problems at and below the level of the injury, according to Dr. Brett Osborn, a neurosurgeon who practices in Florida. (He was not involved in Onward’s study or the surgery.)
“The spinal cord is mostly a bundle of nerve fibers that descend from the brain like wires,” he said. “If you cut or damage the cables, everything below the injury malfunctions. In a human, this manifests as weakness or paralysis.”
He added, “But what if there was a way to ‘bypass’ the injured region of the spinal cord and directly stimulate the nerve cells that interface with the axons at every spinal level? This is precisely what Onward is attempting to do.”
As Osborn explained, Onward’s technology aims to reestablish the connection between the brain and the nerve roots, bypassing or bridging the level of the spinal cord injury.
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“The wiring is not being repaired — that’s many years in the future. But this is a fancy workaround utilizing state-of-the-art implant technology and AI,” he said.
Echoing Bloch’s and Courtine’s earlier comments, Osborn noted that restoring movement will require a cooperative effort between the patient and the implanted unit.
“As the unit will possess learning capacity, the patient’s brain will also ‘learn’ to use the device to its fullest capacity,” he said. “It will be akin to learning a new skill — to juggle, for example.”
“The brain makes the necessary changes at the cellular level to produce the motor patterns needed to successfully coordinate the rhythmic tossing of the balls, or, in this case, make a muscle.”
“Our nervous system is the most complex object in the universe.”
“AI is our friend here — without which spinal cord-injured patients have little hope,” Osborn added. “After all, our nervous system is the most complex object in the universe.”
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Dr. Harvey Castro, an emergency medicine physician in Coppell, Texas, is also a consultant and speaker on AI in health care.
“As an ER doctor with two decades of experience in patient care, I find the first in-human implant of ONWARD® Medical’s ARC-IM Stimulator with a Brain-Computer Interface (BCI) to be a significant milestone in spinal cord injury treatment,” he told Fox News Digital.
“However, as with any groundbreaking technology, ethical considerations, pros, cons and unknowns should be scrutinized.”
Among ethical considerations, Castro emphasized the need to clarify the informed consent of potential risks and benefits, data privacy measures and accessibility of the technology.
He also pointed out that many unknown factors remain, specifically in terms of safety concerns, long-term effectiveness and potential interference with other bodily functions or existing medical devices.
“While this technology heralds a promising future for SCI patients, rigorous clinical trials, ethical safeguards and long-term studies are essential for its validation and broader application,” Castro concluded.
For more Health articles, visit www.foxnews.com/health.
Health
Deadly virus samples went missing from lab in ‘major biosecurity breach,’ say authorities
Hundreds of deadly virus samples are missing from a laboratory in Australia, the Queensland government announced on Monday.
The government has instructed Queensland Health — Australia’s public health department — to launch an investigation into what’s being described as a “major historical breach of biosecurity protocols,” according to the online media statement.
It was reported that 323 vials of multiple infectious viruses — including Hendra virus, Lyssavirus and Hantavirus — went missing from Queensland’s Public Health Virology Laboratory in August 2023.
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Hendra is a zoonotic (animal-to-human) virus that has only been found in Australia.
Hantavirus is a family of viruses that can lead to serious illness and death, according to the Centers for Disease Control and Prevention, while Lyssavirus is a group of viruses that can cause rabies.
The lab where the samples went missing provides “diagnostic services, surveillance and research for viruses and mosquito and tick-borne pathogens of medical importance,” the release stated.
It is not known whether the infectious samples were stolen or destroyed, the statement said, and there is “no evidence of risk to the community.”
The government has launched a “Part 9 investigation.”
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“With such a serious breach of biosecurity protocols and infectious virus samples potentially missing, Queensland Health must investigate what occurred and how to prevent it from happening again,” Minister Timothy Nicholls said in the release.
“The Part 9 investigation will ensure nothing has been overlooked in responding to this incident and examine the current policies and procedures in operation today at the laboratory.”
“This investigation will also consider regulatory compliance and staff conduct.”
Nicholls added that Queensland Health has taken “proactive measures,” including retraining staff on required regulations and conducting audits to ensure correct storage of materials.
Sam Scarpino, PhD, director of AI and life sciences at Northeastern University in Boston, confirmed that the situation in Australia amounts to a “critical biosecurity lapse.”
“Given the limited ability for any of these pathogens to transmit from person to person, the risk of an epidemic is very low.”
“The pathogens reported missing are all high-consequence and could pose a threat to the public,” he told Fox News Digital.
The three pathogens can have very high fatality rates in humans, Scarpino said, but they do not transmit readily from person to person.
“Some hantaviruses have case fatality rates of up to 15%, or over 100 times more lethal than COVID-19, while others are more similar to COVID-19 in terms of severity,” he said.
There is also a high risk to animals and livestock from all three pathogens, he added.
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The Lyssavirus family contains the rabies virus, which is almost universally fatal in humans if they do not receive treatment in time, the expert noted.
“Given the limited ability for any of these pathogens to transmit from person to person, the risk of an epidemic is very low,” Scarpino said.
“However, Hendra virus — along with certain members of the Hantavirus and Lyssavirus family — can be very severe in humans and animals.”
Chief Health Officer Dr. John Gerrard reiterated in the media statement that there is no evidence of public risk.
“It’s important to note that virus samples would degrade very rapidly outside a low temperature freezer and become non-infectious,” he said.
“It’s very unlikely that samples were discarded in general waste, as this would be completely outside routine laboratory practice.”
There have been no human cases of Hendra or Lyssavirus in Queensland over the past five years, Gerrard noted, and no confirmed Hantavirus infections “ever in Australia.”
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Despite the low risk, Scarpino said, “It’s important to understand where these samples ended up, to confirm that there is no longer a risk of exposure.”
“While I applaud the Australian government for taking this seriously, it’s unacceptable that it took over a year for news of the breach to be made public.”
“The pathogens reported missing are all high-consequence.”
There have been similarly high-profile biosecurity lapses in the U.S., Scarpino noted.
“It’s clear that we need quite a bit more investment and transparency related to pathogen biosecurity,” he added.
For more Health articles, visit www.foxnews.com/health
Fox News Digital reached out to the Queensland government requesting further comment.
Health
CDC warns of deadly drug 100 times more potent than fentanyl, overdoses spike in past year
Fentanyl has made headlines for driving overdose deaths, but the Centers for Disease Control and Prevention (CDC) is warning of the rise of an even deadlier drug.
Last year, nearly 70% of all U.S. overdose deaths were attributed to illegally manufactured fentanyls (IMFs). One of those was carfentanil, an altered version of fentanyl that is said to be 100 times more potent, the CDC warned in a Dec. 5 alert.
Deaths from carfentanil rose by more than 700% in the past year, according to the same source — there were 29 deadly overdoses between January and June 2023, and 238 in that same time frame in 2024.
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This data came from the CDC’s State Unintentional Drug Overdose Reporting System (SUDORS).
The numbers could actually be higher, as the 2024 data is preliminary and not all overdose deaths have been reported, the agency noted.
Since an outbreak of carfentanil-linked deaths in 2016 and 2016, the drug had “largely disappeared” until this recent reemergence, the CDC noted.
Based on the increase in fatal overdoses, the CDC is calling for “rigorous monitoring” of carfentanil and other opioids more potent than fentanyl.
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As with other illicit drugs, its “high profitability” likely drives its prevalence, according to Dr. Chris Tuell, clinical director of addiction services at the University of Cincinnati College of Medicine.
“Very small amounts can produce thousands of doses,” he told Fox News Digital.
“Synthetic opioids like carfentanil are relatively easy to manufacture in illicit labs,” Tuell went on. “Since the drug is a synthetic, it is easier to produce — unlike heroin, which is dependent on a plant like opium.”
Why is carfentanil so dangerous?
Carfentanil is 10,000 more times more potent than morphine and 100 times more potent than fentanyl, Tuell confirmed.
“Even a small amount can be fatal, as it can cause respiratory failure,” he said.
One of the major concerns with carfentanil and fentanyl is that they are frequently mixed with other drugs, such as benzodiazepines, cocaine and opioids, which can lead to accidental overdoses, according to Tuell.
“Carfentanil can also resemble cocaine and heroin, so it blends right in with the other drugs,” he warned.
“Even a small amount can be fatal, as it can cause respiratory failure.”
“Even a tiny amount can increase the potency of a drug mixture, leading to a stronger and longer-lasting high.”
Carfentanil often appeals to drug users who have a high tolerance to opioids because they seek a stronger substance, “making the drug attractive despite the risk,” Tuell noted.
How is the drug administered?
Carfentanil can be injected and is frequently mixed with other opioids or heroin, Tuell said. In a powder form, it can be inhaled.
“Inhaling the drug can be quickly risky because it can enter the bloodstream, resulting in an overdose,” Tuell warned. “This can happen intentionally or accidentally, as the drug can become easily airborne.”
Carfentanil can sometimes be in the form of “pressed pills” that resemble prescription medications, the expert said.
“Carfentanil can be lethal at the 2-milligram range depending on the route of administration,” he cautioned.
What parents should know
“Children are now the generation of artificial intelligence and deepfakes, as illicit drugs are posing like regular prescription medications,” Tuell cautioned.
To help protect kids from the dangers of illicit drugs, the expert emphasized the importance of open communication and education.
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“Educate your child about the dangers and risks of drug use, including synthetic opioids like carfentanil,” he advised.
Parents should provide monitoring and supervision of their children, be aware of their social circles and limit unsupervised online activities, Tuell recommended.
“I also believe it is important that parents realize that 84% of individuals with a substance use disorder also have a co-occurring mental health issue,” he added.
“Seeking out mental health services for your child could help address the underlying issues that may have led to a substance use disorder.”
For more Health articles, visit www.foxnews.com/health
The CDC called for specific efforts in preventing deaths from illegally manufactured fentanyls, “such as maintaining and improving distribution of risk reduction tools, increasing access to and retention of treatment for substance use disorders, and preventing drug use initiation.”
Fox News Digital reached out to the Drug Enforcement Administration (DEA) for comment.
Health
Read the Letter From Nobel Laureates Urging That Mr. Kennedy Not be Confirmed
December 9th, 2024
To Members of the United States Senate:
We, the undersigned Nobel Laureates, are writing to ask you to
oppose the confirmation of Robert F. Kennedy, Jr. as Secretary of the
Department of Health and Human Services (DHHS).
The proposal to place Mr. Kennedy in charge of the federal agencies
responsible for protecting the health of American citizens and for
conducting the medical research that benefits our country and the
rest of humanity has been widely criticized on multiple grounds. In
addition to his lack of credentials or relevant experience in
medicine, science, public health, or administration, Mr. Kennedy has
been an opponent of many health-protecting and life-saving
vaccines, such as those that prevent measles and polio; a critic of
the well-established positive effects of fluoridation of drinking
water; a promoter of conspiracy theories about remarkably
successful treatments for AIDS and other diseases; and a belligerent
critic of respected agencies (especially the Food and Drug
Administration, the Centers for Disease Control, and the National
Institutes of Health). The leader of DHHS should continue to nurture
and improve— not threaten—these important and highly respected
institutions and their employees.
In view of his record, placing Mr. Kennedy in charge of DHHS would
put the public’s health in jeopardy and undermine America’s global
leadership in the health sciences, in both the public and commercial
sectors.
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