(NEW YORK) — Elon Musk announced that his company Neuralink implanted a brain chip in a human in a preliminary clinical study. If research studies continue to look promising, devices like these could one day be a “game changer” for people with limited motor function, experts told ABC News.
Neuralink says its goal is to help people living with debilitating conditions, including paralysis, communicate and control external devices with their thoughts.
The patient who received the implant is “recovering well,” Musk said in a post on X Tuesday.
Musk’s company is not alone in developing this type of technology. In recent years, research teams from across the globe have announced early but promising studies of brain-machine interface devices.
Here’s what else to know about Neuralink:
Neuralink’s implant
Neuralink was founded in 2016 by Musk and a team of scientists and engineers. The company says its mission is to “create a generalized brain interface to restore autonomy to those with unmet medical needs,” according to its website.
The company says its device can interpret neural activity so a person can operate a computer or smartphone by simply thinking.
People paralyzed from a stroke, a traumatic brain injury or a spinal cord injury could see the benefits, the company says.
“This would be a major game changer if it could be proven to be safe and effective,” Dr. Leah Croll, a neurologist and assistant professor at Temple University, told ABC News.
Human trials after animal testing
The FDA approved Neuralink for human trials in May after years of testing on animals.
The company has previously demonstrated the ability of the implant to stimulate movement in pigs and monkeys, even demonstrating a monkey with a brain chip playing a video game.
Musk said the first human users will be those who lost the use of their limbs.
“Imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer, that is the goal,” Musk said.
Science fiction into reality
Neuralink’s engineers aren’t the only ones exploring this emerging science.
Last year, Swiss researchers said they combined artificial intelligence and brain and spine implants to help a man paralyzed in a motorcycle accident walk again.
And a woman who had lost her voice to paralysis was able to have a conversation with her husband again, with the help of a mind-controlled avatar, the Swiss researchers said.
“I really do think that in my lifetime as a physician I’ll be able to use this type of technology to help my patients and I cannot wait for that day to come,” Croll said after Musk’s announcement Tuesday.
(PHILADELPHIA) — The Philadelphia Department of Public Health is warning that several people may have recently been exposed to hepatitis A at a grocery store.
An employee at a ShopRite, located in the northeast part of the city, was confirmed to have “acute hepatitis A” and was working behind the meat counter between Jan. 4 and Jan. 21 while possibly contagious, said officials.
“The store is aware of the situation and is working collaboratively with the Health Department,” the agency wrote in a statement.
While calling the risk of infection “very low,” the health department says beef or pork purchased from the store during this period and since frozen “should be discarded as a precaution.” Additionally, anyone who has handled or eaten raw or undercooked beef or pork purchased from the store’s meat counter between Jan. 4 and Jan. 21 should be vaccinated against hepatitis A “as soon as possible,” the health department says.
“People who have previously received two doses of Hepatitis A vaccine OR have had Hepatitis A in the past do not need to be vaccinated,” the department of health further notes.
No details about the infected worker are available, and it’s unclear how many people may have been exposed to the hepatitis A virus due to possible secondary exposures from people who brought meat home or potential cross-contamination at the store, a spokesperson for the Philadelphia Department of Public Health told ABC News. It’s assumed that the infected employee was unvaccinated, the spokesperson said.
So far, there have been no additional reports of hepatitis A and no other ShopRite locations have been affected, according to the Philadelphia Department of Health.
The Philadelphia Department of Health began offering free hepatitis A vaccines on Saturday to anyone who may have been exposed, with 61 people vaccinated as of Monday morning, the spokesperson told ABC News.
Hepatitis A is a very contagious infection that affects the liver and is caused by the hepatitis A virus, according to the Centers for Disease Control and Prevention (CDC).
The virus is found in the stool and blood of infected people and is spread through close, personal contact with an infected patient or by eating contaminated food and drink, even in microscopic amounts, the CDC says.
The CDC says a person can transmit hepatitis A without showing symptoms and can do so up to two weeks before symptoms appear. Symptoms include yellowing of the skin or eyes, loss of appetite, stomach pain, nausea, vomiting, fever and diarrhea.
There are no specific treatments for hepatitis A, with doctors typically recommending rest, adequate nutrition, and fluids, according to the CDC.
Most people recover completely, but in rare cases, hepatitis A can lead to liver failure and death, but this is more common among those with underlying conditions such as chronic liver disease, according to the CDC.
To protect against hepatitis A, the CDC recommends receiving the hepatitis A vaccine. There are two types: one given as two shots six months apart, and the other a combination vaccine that protects against hepatitis A and B and that is given as three shots over six months.
If someone has been exposed to the virus, experts say a single shot of the hepatitis A vaccine given within two weeks may prevent the virus from taking hold.
(NEW YORK) — The Centers for Disease Control and Prevention (CDC) is warning clinicians to remain on alert for measles cases due to a growing number of infections.
Between Dec. 1, 2023, and Jan. 23, 2024, there have been 23 confirmed cases of measles including seven cases from international travelers and two outbreaks with five or more infections each, according to an email sent this week.
Cases have been reported in Pennsylvania, New Jersey, Delaware and the Washington, D.C. area so far.
Most of these cases were among children and adolescents who had not been vaccinated against measles, despite being eligible.
According to the CDC, most measles cases in the U.S. occur when unvaccinated or partially vaccinated Americans travel internationally, contract the disease and then spread it to those who are unvaccinated upon their return.
The federal health agency said the increase in cases in the U.S. reflects a global rise in infections and that there is a “growing global threat.”
“Due to the recent cases, healthcare providers should be on alert for patients who have: (1) febrile rash illness and symptoms consistent with measles (e.g., cough, coryza, or conjunctivitis), and (2) have recently traveled abroad, especially to countries with ongoing measles outbreaks,” the CDC wrote in its message.
If health care workers suspect a patient has measles, the CDC says the patient should be isolated immediately for at least four days from when symptoms appear and local or state health departments should be notified. The patient should then be tested, post-exposure prophylaxis should be provided to close contacts and all contacts who are not up to date on their measles vaccinations should be vaccinated.
Measles is a very contagious disease with the CDC saying every individual infected by the virus can spread it to up to 10 close contacts if they are unprotected including not wearing a mask or not being vaccinated.
Complications from measles can be relatively benign, including rashes, or they can be much more severe, such as viral sepsis, pneumonia, or brain swelling.
The CDC says anybody who either had measles at some point in their life or who has received two doses of the MMR (measles, mumps, rubella) vaccine is protected against measles.
One dose of the measles vaccine is 93% effective at preventing infection if exposed to the virus. Two doses are 97% effective.
In 2000, measles was declared eliminated from the U.S., thanks to a highly effective vaccination campaign, but outbreaks have popped over the last few years in unvaccinated pockets of the country.
Between November 2022 and February 2023, 85 children were sickened with measles in Ohio, 80 of whom were unvaccinated.
In California, an unidentified person with measles who visited Disneyland caused an outbreak, infecting 125 people between December 2014 and February 2015.
(NEW YORK) — For years, respiratory syncytial virus (RSV) has been the most common reason infants are hospitalized in the U.S. and has hospitalized thousands of elderly people every year.
After decades of trying to develop a vaccine, they became available ahead of this season for the first time for adults aged 60 and older and for pregnant people between 32 weeks’ and 36 weeks’ gestation.
Additionally, for the first time ever, an injectable monoclonal antibody shot to protect babies aged 8 months and younger and certain high-risk children under 24 months also hit the market.
However, the experience of doctors getting their patients immunized has been varied across the country. Supply chain issues hampered efforts and some parents have been reluctant to vaccinate their children, health care experts told ABC News.
“So, before the onset of the RSV season this year, there was so much excitement in the pediatric medical community about these new tools,” Dr. Allison Bartlett, professor of pediatric infectious diseases at the University of Chicago Medicine Comer Children’s Hospital, told ABC News. “We now have what should be an absolute game-changing set of tools. But I have to say, I’m disappointed by the number of families who elected not to provide protection to their babies.”
New RSV vaccines, immunizations
RSV is a common respiratory virus with most children affected by their second birthday, according to the Centers for Disease Control and Prevention (CDC).
Although it typically causes mild, cold-like symptoms and most people recover in one to two weeks, it can be a serious infection for infants and older adults, resulting in hospitalization, the CDC said. Up to 80,000 children younger than age 5 are hospitalized every year.
For babies under 8 months old, two monoclonal antibody shots became available. Monoclonal antibodies are proteins manufactured in a lab that mimic the antibodies the body naturally creates when fighting an infection.
Though given as an intramuscular injection, this shot is different than a vaccine, which activates the immune system.
One of the monoclonal antibody shots, Beyfortus, manufactured by AstraZeneca and Sanofi, reduces the risk of severe RSV disease by about 80%, according to the CDC.
‘Discouraging’ uptake
However, uptake varied across the country. Dr. Alexy Arauz Boudreau, associate chief for pediatrics at Massachusetts General Hospital, told ABC News between 80% and 90% of families in her patient population had their children immunized against RSV.
Comparatively, Bartlett said the immunization was offered to parents of newborns before hospital discharge and more than half of families declined, which she called “discouraging.”‘
She added that in conversations with colleagues who take care of older patients, vaccines available for “that population are being underutilized as well, unfortunately.” CDC data shows just 21.1% of older adults in the U.S. have been vaccinated.
Dr. Eric Biondi, associate chief medical officer for the Johns Hopkins Children’s Center, said he did not have a single parent ask about the RSV immunization.
Vaccine hesitancy, supply chain issues
The doctors said there are various reasons why uptake may not have been as high as they were hoping. Some parents may have been nervous about a new product, despite clinical trial data showing it to be safe and effective.
Other parents may not have even been aware that the product was available or may be experiencing vaccine fatigue, or shot fatigue, due to the COVID-19 pandemic, health care experts told ABC News.
“We’ve kind of been inundated with stuff from the CDC and other places over the last few years that I think there’s. … maybe there’s a little more apathy toward more guidelines,” Biondi said. “Not that they’re wrong or bad, but you can only stay on high alert for so long.”
Then, there were supply chain issues. Officials from the Biden administration met with manufacturers and partners of RSV immunizations including Sanofi, AstraZeneca and Thermo Fisher, in fall 2023 and urged them to speed up production as physicians faced an alarming shortage.
Sanofi, one of the makers of Beyfortus, said in a statement last month that there were some “implementation barriers, including commercial payer coverage and coding issues” and that demand outpaced supply.
The company said it has delivered enough doses to make 1.4 million babies in the U.S. eligible to receive Beyfortus.
As of Dec 2023, 28% of mothers with babies under 8 months said they got their infant the shot, according to a new CDC survey.
While the doctors told ABC News they believe the availability of these tools likely had some effect on hospitalization rates, next year will likely be more telling.
“My suspicion is once the supply chain issues kind of correct themselves, and more kids are getting it, I think next year might be more telling as to how much of an impact [the immunization] really has on the hospital side,” Biondi said.
Bartlett said she’s hopeful that between this winter and fall, there will be more conversations with parents about the real-world implications of the monoclonal antibody shot that will result in more infants getting protected before the next RSV season.
“Our goal with these prevention tools that we have is to put the children’s hospitals out of business,” she said. “You know, we won’t be sad if our ICUs are not full of children with RSV infections. We would much rather than be home and healthy and happy.”
(ATMORE, Ala.) — An Alabama man has become the first ever person executed via a new method, nitrogen gas, on Thursday.
Kenneth Eugene Smith, 58, was sentenced to death for his alleged role in the 1988 murder of Elizabeth Sennett. Her husband, Charles Sennett, allegedly hired someone — who, in turn, hired two men, including Smith — to kill his wife and make it look like a burglary gone wrong.
Smith was to be executed in November 2022 via lethal injection, but, despite multiple attempts, officials were not able to insert an intravenous line to administer the drugs before the death warrant expired.
However, medical and legal experts told ABC News that nitrogen gas as a method for execution is untested and there’s no evidence the method will be any more humane or painless than lethal injection.
“I’ve never heard anyone say, ‘We’ve got this new method of execution. We’ve looked at it carefully. We know that this method of execution will cause a death that will not be cruel. Here’s the evidence,'” Dr. Joel Zivot, an associate professor in the department of anesthesiology at Emory University School of Medicine, told ABC News. “That’s what needed to be said. No one has said that.”
Three states — Alabama, Mississippi and Oklahoma — have approved nitrogen gas as a form of execution and Alabama Gov. Kay Ivey defended the method in a statement to ABC News last week.
“Nitrogen hypoxia is the method previously requested by the inmate as an alternative to lethal injection,” she said. “This method has been thoroughly vetted, and both the Alabama Department of Corrections and the Attorney General’s Office have indicated it is ready to go. The Legislature passed this law in 2018, and it is our job to implement it. I am confident we are ready to move forward.”
What is nitrogen hypoxia?
Nitrogen hypoxia is the term for a means of death caused by breathing in enough nitrogen gas to deprive the body of oxygen — in this case, intended to be used as a method of execution.
The protocol in Alabama calls for an inmate to be strapped to a gurney and fitted with a mask and a breathing tube. The mask is meant to administer 100% pure nitrogen, depriving the person of oxygen until they die.
About 78% of the air that humans breathe is made up of nitrogen gas, which may lead people to believe that nitrogen is not harmful, according to the U.S. Chemical Safety Board.
However, when an environment contains too much nitrogen and the concentration of oxygen becomes too low, the body’s organs, which need oxygen to function, begin shutting down and a person dies.
State officials have argued death by nitrogen gas is a humane, painless form of execution and that the person would lose consciousness before they die.
Problems surrounding lethal injection
Lethal injection has been the method used for most executions in the modern era, according to the Death Penalty Information Center, a non-profit that provides data and analysis on capital punishment.
States and jurisdictions can use a one-, two- or three-drug combination. The three-drug combination involves, firstly, an anesthetic or sedative, then a drug to paralyze the prisoner and, lastly, a drug to stop the heart, the DPIC said.
The one and two-drug method typically use an overdose of an anesthetic or sedative to perform the execution.
Lethal injection was seen as a more humane form of execution that would lead to instantaneous death, Zivot said.
“It replaced the firing squad, it replaced electrocution, it replaced the gas chamber, it replaced hanging, all these kinds of methods are a lot more visual than lethal injection,” he said. “It looked like a prisoner was kind of closing their eyes and falling off to sleep and then dying.”
However, problems have arisen with lethal injections in the form of botched executions. Officials have struggled to find veins, intravenous lines have clogged with the deadly chemicals and prisoners have had violent reactions to the dispensed drugs.
Additionally, there have been shortages of the drugs used for lethal injection.
“Companies that made the drugs used in the lethal injection, some of them did not want to participate in making drugs for killing people,” Jeffrey Kirchmeier, a professor of law at City University of New York School of Law, told ABC News. “So, states, fairly recently. in the last decade or so, began experimenting with different drugs with lethal injection not with a lot of science behind it, but using different drugs that they could access.”
In 2016, Zivot was examining autopsy reports of prisoners who were executed via lethal injection and found that the inmates’ lungs were twice as heavy as they normally weigh. He asked a colleague at Emory to check, and he found the same thing.
They discovered that prisoners who had received lethal injections were suffering from pulmonary edema, which is when fluid builds up in the lungs, making it difficult to breathe. Further research Zivot conducted with NPR found similar results.
“It seemed to me that this was death akin to drowning,” Zivot said. “You are drowning in your own secretions … Lethal injection is actually a myth. The myth is that this is a peaceful death and not a cruel death, and that’s just not true.”
The controversy surrounding execution by nitrogen gas
“So, [officials] think that it will kill quickly, and that this kind of death will appear to be without suffering, will not be cruel, and that’s their claim,” Zivot said.
However, Alabama’s published protocol has been heavily redacted, which initially made it unclear exactly how the execution would be performed, and officials were not planning to release any documentation of the execution afterward, according to Zivot.
“That’s definitely one of the concerns here because so much about executions are done in secrecy,” Kirchmeier, who teaches courses that include capital punishment, said. “It’s a government act, the government is doing this and so it should be something that people have access to, that the media has access to.”
In court, Smith argued there are several ways his execution could go wrong including the mask may not fit properly, or it may dislodge. Additionally, he said the method could cause him to suffer hypoxia short of death, a stroke or leave in him a vegetative state if the method fails.
Kirchmeier also said doctors are not ethically allowed to help with executions including lethal injection or nitrogen gas, so the procedures are not done by doctors with medical expertise.
A court ruled earlier this month that Alabama could proceed with the execution and that it did not find that the method would constitute as “cruel and unusual punishment.”
On Wednesday, the Supreme Court declined Smith’s last-minute request to halt the execution.
Numerous organizations called on Alabama to stay the execution, including the U.N. Human Rights Office, saying execution via nitrogen gas could be classified as torture and violate international human rights treaties.
“We have serious concerns that Smith’s execution in these circumstances could breach the prohibition on torture or other cruel, inhuman or degrading treatment or punishment, as well as his right to effective remedies,” Ravina Shamdasani, spokesperson for the U.N. Human Rights Office, said during a press briefing earlier this month,
Additionally, Sant’Egidio Community, a Catholic charity affiliated with the Vatican, made an appeal to Alabama to halt the execution, calling it “barbaric” and “a new, downward standard of humanity.”
Medical and legal experts told ABC News that despite Alabama officials arguing that nitrogen gas is not cruel, there is no evidence to show that is the case.
“It’s very difficult to kill people humanely, and that’s what the long history of the death penalty has shown [with] these changes in execution methods,” Kirchmeier said. “Every one is hailed as a new method that will be more humane than the previous one, but here we are, after more than 200 years since the country was formed, states are still experimenting with new ways to execute people.”
Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. CREDIT: FDA
(NEW YORK) — With cold and flu season underway, some Robitussin products marketed for the relief of cough, flu and sore throat symptoms are being voluntarily recalled nationwide due to a microbial contamination, the consumer health company Haleon announced Wednesday.
Eight lots of Robitussin Honey CF Max Day cough syrup in four-ounce and eight-ounce bottles and Robitussin Honey CF Max Night cough syrup in eight-ounce bottles, all for adult use, are impacted by the recall. The recalled products carry expiration dates between May 2025 and June 2026. The lot numbers and expiration dates can be found on the Food and Drug Administration’s website.
Immunocompromised individuals can be affected by the potential contamination, including the development of fungemia, the presence of fungi in the blood, or disseminated fungal infection, which can be severe or life-threatening, according to a news release from the FDA.
Those who are not immunocompromised may not develop any life threatening conditions but the FDA noted that “the occurrence of an infection that may necessitate medical intervention cannot be completely ruled out.”
Haleon said it has not received any reports of adverse reactions so far but urged consumers with recalled products to stop using them immediately and return them. Consumers can contact Haleon’s Consumer Relations team at 1-800-245-1040 between Monday through Friday 8 a.m. and 6 p.m. Eastern Time or via email at mystory.us@haleon.com.
“Consumer safety and product quality are our utmost priorities at Haleon,” the company said in a statement to ABC News on Thursday. “After a thorough investigation, a root cause has been identified and we are implementing corrective and preventative actions to ensure that this does not recur.”
(NEW YORK) — A new study in Science is shining a light on the continuing impact of long COVID, with research revealing further and continuing health concerns for some of the 16 million sufferers in the U.S.
Long COVID is a syndrome, or collection of symptoms, that continue or develop after an acute COVID-19 infection and can last weeks, months or years. There is no test to confirm if symptoms are related to long COVID. Some scientists suggest that long COVID is caused by overactive immune cells, but the exact cause remains unclear.
The study followed 113 patients at four different hospitals in Switzerland with mild and severe COVID-19 and found that 40 had symptoms of long COVID at six months, 22 of whom had persistent symptoms at 12 months.
Researchers looked at blood samples from the 40 who experienced long COVID symptoms, compared them to controls who were not infected with COVID-19, and found that those who had long COVID had evidence of inflammation (increased complement activity), blood cell dysregulation (hemolysis and platelet activation) and tissue injury in their blood.
The specific details from the small study may help provide “a basis for new diagnostic solutions,” according to the researchers, for the condition with no known cure or FDA-approved treatments.
While these results finding evidence of inflammation in patients with long COVID symptoms are not entirely surprising nor specific to long COVID, they are a step forward in identifying the cause of long COVID.
It’s more than just researchers, though, looking into developments in our understanding of the syndrome. The condition received renewed attention from the federal government last week, as the U.S. Senate Committee on Health, Education, Labor and Pensions convened a group of patients and experts to testify about the impacts of long COVID before a bipartisan group of Senators.
In the Senate’s first-ever hearing on this topic, Sen. Tammy Baldwin said researchers and government officials need to “increase the sense of urgency” over understanding and treating the condition.
For Sen. Bernie Sanders, chairman of the committee, more needs to be done.
“We think we haven’t done anywhere near enough, and we hope to turn that around,” he said.
Medical experts testified at the hearing, telling the committee that the condition can emerge in patients of all ages and backgrounds, that the risk increases with multiple infections, and rates of long COVID are higher in minority communities.
“The burden of disease and disability from long COVID is on par with the burden of cancer and heart disease,” Dr. Ziyad Al-Aly, M.D., a clinical epidemiologist at Washington University, said. “We must develop sustainable solutions to prevent repeated infections with SARS-CoV-2 and long COVID that would be embraced by the public.”
Patients and Caregivers
Angela Meriquez Vazquez, a long COVID patient from California, testified that she has helped over 15,000 sufferers through online advocacy.
“We are living through the largest mass destabilizing event in modern history,” she told the Senators.
As she told her own story, Meriquez Vazquez, a former runner, said she is currently on 12 medications. Although she said she has managed to continue working, and she has health care, the condition has forced her to work from home, lying down to minimize her symptoms.
“Not since the emergence of the AIDS pandemic has there been such an imperative for large-scale change in healthcare, public health, and inequitable structures that bring exceptional risks of illness, suffering, disability, and mortality,” Meriquez Vazquez said.
One of the Senators — Republican Roger Marshall — shared his own testimony, revealing to the committee that one of his loved ones “is one of the 16 million people” who has “suffered for two years” with the condition.
He told the committee his family member’s illness is “like mono(nucleosis) that does not go away,” adding that the person has seen 30 doctors in an attempt to find help.
Marshall said there needs to be more focus on treatments for long COVID at the Centers for Disease Control and Prevention.
“I’m frustrated that our CDC is more focused on vaccines than they are on treatments,” he said.
Epidemiologists and Researchers weigh in
Dr. Al-Aly, while testifying, repeatedly called on our country’s leaders and medical experts to come together to tackle the ongoing health crisis.
“We are the best nation on earth, and we can solve this,” he said.
One of his proposed solutions is establishing a new multidisciplinary research institute to address infection-associated chronic conditions.
Research into the condition has been “slow,” Dr. Charisse Madlock-Brown, Ph.D. from the University of Iowa, said at the hearing. She noted clinical trials are in the “experimental medicine” phase and pushed for more investment to identify proven treatments.
Sen. Tim Kaine said the National Institutes of Health has been provided more than $1 billion since 2020 to study long COVID, and he urged representatives from NIH to testify before the committee. In 2021, the NIH launched the Researching COVID to Enhance Recovery initiative to identify further risk factors and causes of long COVID.
“We can’t take two years just to get ‘geared up,'” he said.
According to the most recent information from the CDC, long COVID can cause up to 200 symptoms, including chronic fatigue, blood clots, gastrointestinal issues, brain fog and heart issues. Symptoms can last from months to years following a COVID infection. Risk factors for developing long COVID after a COVID-19 infection that have been identified include severe COVID-19 illness, underlying health conditions (such as asthma, diabetes, obesity or autoimmune diseases) and not getting the COVID-19 vaccine.
While the interest from the Senate and the new study in Science are promising, more research needs to be done to find the specific cause of why some people get long COVID from COVID-19, and others do not, and to find effective treatments.
A still image taken from video of a study on gene therapy restoring hearing in children with hereditary deafness. (Mass General Brigham)
(NEW YORK) — Children with hereditary deafness regained their hearing thanks to a type of gene therapy, a new study published on Wednesday found.
In a clinical trial, co-led by investigators from Mass Eye and Ear, a specialty hospital in Boston, six children who had a form of genetic deafness called DFNB9 were examined.
This deafness is caused by mutations of the OTOF gene. This mutation fails to produce a protein known as otoferlin, which is necessary for the transmission of sound signals from the ear to the brain, according to the researchers.
The trial — which began in December 2022 — took place at Eye & ENT Hospital of Fudan University in Shanghai and involved the use of an inactive virus carrying a functioning version of the OTOF gene.
It was carefully introduced into the inner ear of the six children at differing doses, and they were observed for 26 weeks.
Results, published in The Lancet, showed five of the six children, who were classified as having total deafness, recovered their hearing “and the restored ability to conduct normal conversation,” according to a release.
Researchers say this is the first human clinical trial to use a gene therapy for treating this condition, with the most patients treated and the longest follow-up period.
“For us, it really is a milestone,” Dr. Zheng-Yi Chen, an associate scientist in the Eaton-Peabody Laboratories at Mass Eye and Ear and associate professor of otolaryngology–head and neck surgery at Harvard Medical School, told ABC News. “We are absolutely thrilled … It will have a huge impact on the field.”
“Hearing loss affects so many people and, up to now, there’s no single FDA-approved drug to treat any type of hearing loss, including generic hearing loss,” he continued. “So, this is the first time where a brand-new type of gene therapy approach can actually be used to treat the children who are completely deaf and regain the function of hearing.”
Chen said that when children are unable to hear, this can affect their development and have long-lasting impacts. He said this is why it’s recommended for infants to have hearing screenings shortly after birth.
“Communication is essential to children’s development,” he said. “If children cannot hear or cannot communicate, especially in the first three years of their lives, their brain development actually will be severely affected.”
Chen said the next steps are to expand the study to enroll more patients for a larger clinical trial and to follow them for a longer period of time to ensure that the treatment works, with the hopes that it could be expanded to treat more types of genetic deafness.
The findings from the clinical trial will be presented Feb. 3 at the Association for Research in Otolaryngology Annual Meeting in Anaheim, California.
It comes on the heels of a report regarding the first person in the U.S., an 11-year-old boy from Spain, who was treated with a gene therapy, made by pharmaceutical company Eli Lully, to reverse his genetic form of hearing loss, according to his doctors at Children’s Hospital of Philadelphia.
(NEW YORK) — An Alabama man is set to be the first ever person executed via a new method, nitrogen gas, on Thursday.
Kenneth Eugene Smith, 58, was sentenced to death for his alleged role in the 1988 murder of Elizabeth Sennett. Her husband, Charles Sennett, allegedly hired someone — who, in turn, hired two men, including Smith — to kill his wife and make it look like a burglary gone wrong.
Smith was to be executed in November 2022 via lethal injection, but, despite multiple attempts, officials were not able to insert an intravenous line to administer the drugs before the death warrant expired.
However, medical and legal experts told ABC News that nitrogen gas as a method for execution is untested and there’s no evidence the method will be any more humane or painless than lethal injection.
“I’ve never heard anyone say, ‘We’ve got this new method of execution. We’ve looked at it carefully. We know that this method of execution will cause a death that will not be cruel. Here’s the evidence,'” Dr. Joel Zivot, an associate professor in the department of anesthesiology at Emory University School of Medicine, told ABC News. “That’s what needed to be said. No one has said that.”
Three states — Alabama, Mississippi and Oklahoma — have approved nitrogen gas as a form of execution and Alabama Gov. Kay Ivey defended the method in a statement to ABC News last week.
“Nitrogen hypoxia is the method previously requested by the inmate as an alternative to lethal injection,” she said. “This method has been thoroughly vetted, and both the Alabama Department of Corrections and the Attorney General’s Office have indicated it is ready to go. The Legislature passed this law in 2018, and it is our job to implement it. I am confident we are ready to move forward.”
What is nitrogen hypoxia?
Nitrogen hypoxia is the term for a means of death caused by breathing in enough nitrogen gas to deprive the body of oxygen — in this case, intended to be used as a method of execution.
The protocol in Alabama calls for an inmate to be is strapped to a gurney and fitted with a mask and a breathing tube. The mask is meant to administer 100% pure nitrogen, depriving the person of oxygen until they die.
About 78% of the air that humans breathe is made up of nitrogen gas, which may lead people to believe that nitrogen is not harmful, according to the U.S. Chemical Safety Board.
However, when an environment contains too much nitrogen and the concentration of oxygen becomes too low, the body’s organs, which need oxygen to function, begin shutting down and a person dies.
State officials have argued death by nitrogen gas is a humane, painless form of execution and that the person would lose consciousness before they die.
Problems surrounding lethal injection
Lethal injection has been the method used for most executions in the modern era, according to the Death Penalty Information Center, a non-profit that provides data and analysis on capital punishment.
States and jurisdictions can use a one-, two- or three-drug combination. The three-drug combination involves, firstly, an anesthetic or sedative, then a drug to paralyze the prisoner and, lastly, a drug to stop the heart, the DPIC said.
The one and two-drug method typically use an overdose of an anesthetic or sedative to perform the execution.
Lethal injection was seen as a more humane form of execution that would lead to instantaneous death, Zivot said.
“It replaced the firing squad, it replaced electrocution, it replaced the gas chamber, it replaced hanging, all these kinds of methods are a lot more visual than lethal injection,” he said. “It looked like a prisoner was kind of closing their eyes and falling off to sleep and then dying.”
However, problems have arisen with lethal injections in the form of botched executions. Officials have struggled to find veins, intravenous lines have clogged with the deadly chemicals and prisoners have had violent reactions to the dispensed drugs.
Additionally, there have been shortages of the drugs used for lethal injection.
“Companies that made the drugs used in the lethal injection, some of them did not want to participate in making drugs for killing people,” Jeffrey Kirchmeier, a professor of law at City University of New York School of Law, told ABC News. “So, states, fairly recently. in the last decade or so, began experimenting with different drugs with lethal injection not with a lot of science behind it, but using different drugs that they could access.”
In 2016, Zivot was examining autopsy reports of prisoners who were executed via lethal injection and found that the inmates’ lungs were twice as heavy as they normally weigh. He asked a colleague at Emory to check, and he found the same thing.
They discovered that prisoners who had received lethal injections were suffering from pulmonary edema, which is when fluid builds up in the lungs, making it difficult to breathe.
“It seemed to me that this was death akin to drowning,” Zivot said. “You are drowning in your own secretions … Lethal injection is actually a myth. The myth is that this is a peaceful death and not a cruel death, and that’s just not true.”
The controversy surrounding execution by nitrogen gas
“So, [officials] think that it will kill quickly, and that this kind of death will appear to be without suffering, will not be cruel, and that’s their claim,” Zivot said.
However, Alabama’s published protocol has been heavily redacted, making it unclear exactly how the execution will be performed, and officials are not planning to release any documentation of the execution afterward, according to Zivot.
“That’s definitely one of the concerns here because so much about executions are done in secrecy,” Kirchmeier, who teaches courses that include capital punishment, said. “It’s a government act, the government is doing this and so it should be something that people have access to, that the media has access to.”
In court, Smith argued there are several ways his execution could go wrong including the mask may not fit properly, or it may dislodge. Additionally, he said the method could cause him to suffer hypoxia short of death, a stroke or leave in him a vegetative state if the method fails.
Kirchmeier also said doctors are not ethically allowed to help with executions including lethal injection or nitrogen gas, so the procedures are not done by doctors with medical expertise.
A court ruled earlier this month that Alabama could proceed with the execution and that it did not find that the method would constitute as “cruel and unusual punishment.”
On Wednesday, the Supreme Court declined Smith’s last-minute request to halt the execution.
Numerous organizations have called on Alabama to stay the execution, including the U.N. Human Rights Office, saying execution via nitrogen gas could be classified as torture and violate international human rights treaties.
“We have serious concerns that Smith’s execution in these circumstances could breach the prohibition on torture or other cruel, inhuman or degrading treatment or punishment, as well as his right to effective remedies,” Ravina Shamdasani, spokesperson for the U.N. Human Rights Office, said during a press briefing earlier this month,
Additionally, Sant’Egidio Community, a Catholic charity affiliated with the Vatican, made an appeal to Alabama to halt the execution, calling it “barbaric” and “a new, downward standard of humanity.”
Medical and legal experts told ABC News that despite Alabama officials arguing that nitrogen gas is not cruel, there is no evidence to show that is the case.
“It’s very difficult to kill people humanely, and that’s what the long history of the death penalty has shown [with] these changes in execution methods,” Kirchmeier said. “Every one is hailed as a new method that will be more humane than the previous one, but here we are, after more than 200 years since the country was formed, states are still experimenting with new ways to execute people.”
(NEW YORK) — A North Dakota state court denied a request to temporarily block the state’s strict abortion ban on Tuesday.
Plaintiffs challenging the ban had asked the court to allow doctors to resume performing abortions to preserve the life or health of a pregnant person, based on their “good-faith medical judgment.”
While Burleigh County District Court said it would not block the state’s strict ban for now, the court has not yet issued a final decision on whether the ban violates the state constitution.
“The Center for Reproductive Rights filed the challenge in 2023, arguing that the strict exceptions in the ban are too narrow and violate the state constitution. The Court’s denial of the injunction is based on the injunctive relief sought and is not a ruling that the ban is constitutional or consistent with pregnant people’s rights or wellbeing,” the Center for Reproductive Rights said in a statement.
The CRR said that the court will make a final decision on the constitutionality of North Dakota’s abortion ban after it hears testimony and evidence in court.
“Though we are disappointed by today’s decision, the court did not reach the constitutional questions at the heart of this case, and we remain confident that we will prevail after the court hears further evidence of how this law harms pregnant North Dakotans,” said Meetra Mehdizadeh, a staff attorney at the CRR.
The North Dakota Supreme Court already blocked another ban — the state’s trigger ban on abortion — which it deemed was unconstitutional because it did not allow exceptions to save the life or preserve the health of a pregnant person.
“The North Dakota Constitution explicitly provides all citizens of North Dakota the right of enjoying and defending life and pursuing and obtaining safety. These rights implicitly include the right to obtain an abortion to preserve the woman’s life or health,” the court said in a March 2023 opinion.
The trigger ban was set to go into effect, making it a felony to perform an abortion, with exceptions for rape, incest or to save the life of a mother.
In April 2023 — just one month after that opinion was issued — state lawmakers adopted another strict abortion ban, which is being challenged in the ongoing lawsuit.
That ban, which is currently in effect, makes performing or aiding an abortion a class C felony, punishable by up to five years in prison and/or a fine of up to $10,000.
While the abortion ban includes an exception to save the life of a mother, plaintiffs argue that the ban keeps patients from being able to access care.
“While the amended abortion ban has an exception for health, the exception is too narrow to allow pregnant people to access care in situations where their health is at risk,” the lawsuit argues.
The suit also argues that the ban does not provide a “discernible standard” for when physicians can provide legal abortion care and does not allow them to rely on “good-faith medical judgment” to determine whether an abortion is necessary to protect the life and health of a patient.
The suit also argues that patients with nonviable pregnancies that pose risks to patients’ health are unable to get care in North Dakota and have to travel out of state.
