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.
(NEW YORK) — As a surge of respiratory viruses, including COVID-19 and influenza, continue to spread across the United States, experts are warning it could lead to a rise in cardiovascular complications.
Weekly COVID hospitalizations are currently sitting at 32,861 for the week ending Jan. 13, lower than the week before but similar to levels seen in January 2023, according to data from the Centers for Disease Control and Prevention (CDC).
Similarly, there were 14,874 weekly flu hospitalizations, lower than the week before but comparable to levels seen in November 2023, the data shows.
Many Americans may assume that complications from respiratory illnesses are limited to sinusitis, bronchitis, pneumonia and other sicknesses that affect the upper or lower respiratory tracts.
However, Dr. Deepak Bhatt, director of Mount Sinai Fuster Heart Hospital in New York City, said there are two potential routes by which these infections can contribute to heart problems.
“The more common pathway is if somebody gets really sick, say with influenza, running a high fever or getting dehydrated, getting hospitalized because of complications of influenza,” he told ABC News. “That’s a setup for having heart problems.”
Fever or dehydration can raise a patient’s heart rate and, particularly for those who have heart disease or heart disease risk factors, this can be very dangerous. Additionally, respiratory infections can cause inflammation, which, in turn, can cause plaques in the blood to form clots — a potential trigger of heart attacks.
“The inflammation is a result of any serious infection but, including infections like influenza and COVID, can then cause inflammation at the site of plaque buildup in a heart artery and that can help promote that plaque to rupture,” Bhatt said. “Or in other words, flowing blood is exposed to the inner contents of that fat and cholesterol and when that happens, blood clots form, and if they block the artery completely, that’s what can cause a heart attack.”
The other pathway, which is more direct but rarer, is myocarditis, which is inflammation of the heart muscle, usually following a virus.
Myocarditis can cause arrhythmias, which are rapid or abnormal heartbeats. It can also cause the heart muscle to weaken, resulting in cardiomyopathy, which affects the heart’s ability to pump blood effectively.
Additionally, in rare circumstances, myocarditis can lead to heart failure and cardiogenic shock — another condition in which the heart can’t pump enough blood to meet the body’s needs — even in otherwise healthy patients.
While these conditions are more likely to affect older adults, those with known heart disease, or those have known multiple cardiovascular risk factors, Bhatt said there may be people who don’t know they’re at risk.
“One challenge with heart disease is not everybody knows that they have it,” he said. “That is, there are people that are walking around with heart disease, but the diagnosis hasn’t been made, because they’ve not had any symptoms yet.”
He continued, “But the stressor of a really severe illness, like influenza, can sort of then unmask what has sort of been there all along, but sitting there silently.”
Bhatt recommends anyone who is not yet vaccinated against flu and COVID, and RSV for older adults, should get their shots now.
CDC data showed that uptake has been lagging. As of Friday, just 21.5% of adults aged 18 and older have gotten the updated COVID vaccine and 46.7% have gotten the flu shot. Additionally, just 2.1% of adults aged 60 and older have gotten the RSV vaccine.
More importantly, if someone is sick and they have chest pain or are out of breath that is worsening, they should call their doctor or 911, regardless of whether or not they have an underlying condition or risk factors, he said.
“If somebody’s having really significant discomfort in the chest and symptoms in the chest, and it’s getting worse, especially rapidly, don’t just assume it’s because, ‘Oh, I have a bad cold, or I have influenza, or I have COVID,” Bhatt said. “Calling 911 is always the right thing to do.”
(NEW YORK) — The Biden administration announced new steps Monday to expand access to contraception, abortion medication and emergency abortion care at hospitals on what would have been the 51st anniversary of Roe v. Wade.
It’s the latest attempt by the federal government to preserve abortion access and protect reproductive health care since the Supreme Court’s decision in June 2022 to end federal protections for abortion rights.
The initiatives are expected to be announced at a meeting President Joe Biden is holding Monday afternoon with his Task Force for Reproductive Healthcare Access, during which physicians who practice in states where abortion was restricted following the overturning of Roe will discuss their personal experiences.
Woman travels to New Mexico for abortion care not offered to her in Texas, joins suit
To strengthen contraception access, the administration said it will implement several measures, including federal agencies issuing new guidance to “clarify standards” and make sure Food and Drug Administration-approved contraceptive medications are available for free under the Affordable Care Act.
Xavier Becerra, the secretary of Health and Human Services, issued a letter Monday to various insurers — including private companies, state Medicaid plans, Medicare plans and the Children’s Health Insurance Program — reminding them of their obligations to cover contraceptives for those on their plans.
“As a reminder, plans and issuers subject to the requirement to cover preventive services must provide the full range of FDA-approved, -cleared or -granted contraceptives (including emergency contraception), effective family planning practices, and sterilization procedures to prevent unintended pregnancy and improve birth outcomes,” he wrote.
Additionally, the Office of Personnel Management will offer new guidance to insurers making sure contraception access is strengthened for federal workers, retirees and family members.
The HHS is also announcing a “comprehensive plan” to increase awareness and understanding about the Emergency Medical Treatment and Labor Act, which requires patients to receive emergency medical care regardless of their ability to pay.
In July 2022, the HHS issued guidance that under the EMTALA, which was passed in 1986, doctors must perform abortions in emergency departments — even in states where the procedure is illegal — if the patient needs “stabilizing medical treatment” for an emergency medical condition.
A court has ruled Texas doctors don’t need to perform emergency abortions. Here’s what that means:
The administration’s new initiative will also include distributing resources about rights for patients and materials for health care providers about complying with federal requirements. It comes as the Supreme Court is set to hear a case about whether abortion care can be provided under the EMTALA.
The Supreme Court is also expected to review a lower court’s decision to restrict nationwide access to mifepristone, one of two abortion pills, which was approved by the FDA in 2000.
In the Monday announcement from the White House, the administration said the FDA and the Department of Justice would defend access to mifepristone before the court.
Separately, Vice President Kamala Harris is kicking off a series of abortion rights events, starting in Wisconsin on Monday, where she is expected to denounce a recent bill presented by Republican lawmakers to limit abortion after 14 weeks.
“Even as Americans — from Ohio to Kentucky to Michigan to Kansas to California — have resoundingly rejected attempts to limit reproductive freedom, Republican elected officials continue to push for a national ban and devastating new restrictions across the country,” Biden said Monday in a statement. “On this day and every day, Vice President Harris and I are fighting to protect women’s reproductive freedom.”
During a press briefing Monday, Jen Klein, director of the White House Gender Policy Council, said Biden has been urging Congress to restore federal protections for abortion.
“The president has been quite clear since Roe v. Wade was overturned, the ultimate solution is to pass federal national legislation to restore the protections in Roe, and we will continue to work to hope that Congress will pass that legislation so the president can sign it,” she said.
Since the Supreme Court’s decision, at least 16 states have ceased nearly all abortion services, according to an ABC News tally.
Arizona, Florida, Nebraska, North Carolina and Utah also have bans in place ranging from 12 weeks to 18 weeks, according to the Guttmacher Institute, a research group that studies sexual and reproductive rights.
Sarah Ferguson, Duchess of York, is speaking out after revealing she has been diagnosed with malignant melanoma, her second cancer diagnosis within the past year.
“Naturally another cancer diagnosis has been a shock but I’m in good spirits and grateful for the many messages of love and support,” Ferguson wrote in an Instagram post Monday, adding, “I am resting with family at home now, feeling blessed to have their love and support.”
Ferguson — who was previously married to Prince Andrew and is the mother of their two daughters, Princesses Beatrice and Eugenie — was diagnosed last summer with breast cancer, for which she underwent a mastectomy.
A spokesperson for the duchess said Sunday that Ferguson’s dermatologist requested several moles be “removed and analyzed” at the same time she was undergoing reconstructive surgery following her mastectomy.
One of the moles that was removed was “identified as cancerous,” according to the spokesperson.
“She is undergoing further investigations to ensure that this has been caught in the early stages,” the spokesperson said in a statement. “Clearly, another diagnosis so soon after treatment for breast cancer has been distressing but the duchess remains in good spirits.”
Ferguson said on Instagram that she hopes sharing her diagnosis will help encourage people to get checked for cancer.
“I believe my experience underlines the importance of checking the size, shape, colour and texture and emergence of new moles that can be a sign of melanoma and urge anyone who is reading this to be diligent,” she wrote.
What to know about melanoma
Melanoma is treated by surgically removing the primary tumor and surrounding normal tissue. Immunotherapy and other targeted therapy may also be used to treat advanced melanoma. The estimated 5-year survival for melanoma ranges from 99.5% for localized disease, to 31.9% for disease that has spread. Death rates have been declining largely due to advances in treatment.
Per the CDC, for every 100,000 people, 20 new cases of melanoma are reported each year, and two people die. It is the sixth most common cause of cancer in men and women. Over two-thirds of melanomas are diagnosed among adults 55 and older.
The USPSTF has found that the current evidence is inconclusive regarding screening asymptomatic adolescents and adults by visual skin examination. Those who have a suspicious skin lesion, or who have a familial syndrome, should be monitored more closely.
Avoiding sunburn and using sunscreen can reduce the risk of melanoma. Also avoiding UV exposure from tanning beds or other devices can also lower risk. Having another type of skin cancer, or breast or thyroid cancer increases your risk of melanoma.
(NEW YORK) — Dr. Thomas Wagner, founder of the biotech company Orbis Health Solutions and cancer researcher, has made it his life’s mission to find a way to treat cancer without the dreaded side effects that, for some, can become worse than the cancer itself or may even lead to an earlier death.
“The tragedy of cancer is not just that person, the diagnosis, but it’s also the fear of the therapy,” Wagner told ABC News.
Many traditional cancer treatments, such as chemotherapy, work by killing off cancer cells but also kill off non-cancerous cells throughout the body. This can cause a range of side effects including hair loss, nausea, vomiting, or may knock out a person’s immune system putting them at risk of life-threatening infections, Wagner said.
After seeing cancer patients suffer from debilitating side effects of their treatment, Wagner began his mission to develop a cancer treatment that harnessed the power of a person’s immune system instead of eliminating it. This treatment was developed as a vaccine that has now been studied for decades, and each shot is completely personalized to each patient.
Typically, cancer cells evade a person’s immune system because it is recognized as that person’s cells. Wagner developed a tumor lysate particle only (TLPO) vaccine that uses a person’s tumor cells to identify particular parts that are then presented back in the body using the vaccine in a way that can stimulate their immune system to gain the ability to detect these cancer cells like an infection, allowing the immune system to fight the cancer itself.
“People used to ask me the question, ‘When will there be a cure for cancer?’ And I’ve been doing this for 60 years and I could never answer that question,” Wagner said. “Until recently, until the last three or four or five years.”
Wagner believes this type of cancer treatment could be a key to finding the long-awaited cure for cancer, all cancers, if paired with early detection.
What we know about this cancer vaccine so far
Wagner’s TLPO cancer vaccine has been tested in hundreds of patients with advanced forms of melanoma in Phase 2 clinical trials.
The most recent data presented at an academic conference showed nearly 95% of people given only the vaccine were still alive three years after starting treatment and 64% were still disease-free. Among the most advanced forms of melanoma, disease-free survival after three years for people with stage III disease was 60% in the vaccine-only group, compared to about 39% in the placebo group. Disease-free survival for those with stage IV disease was about 68% in the vaccine-only group, and zero in the placebo group.
The most common side effects were redness or pain at the injection site, fever and fatigue after the injection – similar to other vaccines that stimulate an immune response.
Dr. Vernon Sondak, cutaneous oncologist at Moffit Cancer Center who was not involved in the clinical trial but has worked with tumor lysate vaccines throughout his career, told ABC News that these results are promising, but point out that the Phase 2 clinical trials aren’t conclusive. A larger Phase 3 clinical trial will have to ultimately validate if this cancer vaccine will truly be a game-changer in the field.
“We’ve seen over and over again, promising Phase 2 data that didn’t turn out to be so promising in Phase 3,” Sondak cautions.
Based on this data and other studies, the Food and Drug Administration (FDA) has greenlit Wagner’s vaccine to start a Phase 3 clinical trial. It will be a three-year endeavor with a goal to enroll 500 people and is planned to launch sometime this year, Riley Polk, president of Orbis Health Solutions, told WLOS, an ABC News affiliate in Asheville, North Carolina.
Polk said he has been personally impacted by the success of this vaccine after his father went through numerous lung surgeries for cancer over a decade ago but was left with no other treatment options. His father opted to try Wagner’s cancer vaccine and lived 10 more years before dying from something unrelated to cancer. “You can tell me a lot of things, but you can’t tell me [the vaccine] doesn’t work,” Polk said.
Financial barriers have prevented progress
Polk said the planned Phase 3 clinical trial is a $100 million project – those funds are often drops in the bucket for larger pharmaceutical companies and those backed by venture capitalists.
For smaller, private companies, securing that level of financial resources is a challenge that Polk said limits their ability to fund more clinical trials that could expand the potential indications for Wagner’s cancer vaccine.
To circumvent some of that challenge and get this treatment to more people that can produce more results, Wagner and his team just began what’s called a basket trial, a type of clinical trial approved by the FDA that allows the same vaccine that showed success in the melanoma clinical trials to be tested in anyone with a solid tumor who meets certain inclusion criteria. People in this trial need to have a low or minimal tumor burden so most will have already received some type of treatment prior to getting this vaccine, Wagner said.
The first person to receive this vaccine under this basket trial was Catie King, a native of Asheville, North Carolina, who was diagnosed with ovarian cancer six years ago. King said she felt great after the first round of treatment, only experiencing some redness at the injection site, but no other side effects, WLOS reported.
“Now how many people do you know, with a cancer therapy that say they feel better because of the therapy?” Wagner asked, who has numerous anecdotal accounts of other patients echoing King’s experience of feeling better, some even energized, after starting treatment with this vaccine.
For King, who is in the farming industry with her husband, the lack of side effects makes a meaningful difference in her life, by not impacting her daily routine at all.
“With this vaccine, there haven’t been any hard days,” King said, which she noted was not the case when she previously underwent low-dose chemotherapy for her cancer.
Polk said seven other people have received the vaccine through the basket trial who have a types of brain, lung and breast cancer. But there have been hundreds of other patients who have received this vaccine or its precursor over the last 20 years.
One of those patients is a woman named Mary Carol Abercrombie who Wagner believes is one of the longest surviving people previously diagnosed with stage 4 melanoma, the most advanced form of the disease. Just before Christmas in 2001, Abercrombie told WLOS she completed a year of cancer treatment with “horrendous” side effects but once the treatment stopped, her cancer advanced. Abercrombie said her doctors told her she only had a few more months to live, telling her to “just enjoy Christmas.”
Abercrombie’s surgical oncologist at the time was working with Wagner on a cancer vaccine. “Sign me up, ’cause there wasn’t anything [else] out there,” Abercrombie said, who was just hoping to live long enough to see her son get married that year. Over 20 years have since passed and Abercrombie said her melanoma has never recurred. She not only saw her son get married, but she’s watching her four grandchildren grow up.
Before this vaccine can be more widely available to treat people with melanoma, it needs to show success over years in a phase 3 clinical trial and then get final approval by the FDA. Before it can have even broader use, it will need to show success in the basket trial, then move into more specific clinical trials for other indications which will take years and millions of dollars.
Polk said he hopes data from the basket trial will get the attention of larger pharmaceutical companies. Through that type of partnership and with other funding mechanisms, they could eventually do more extensive trials through the FDA.
Dr. Jade A Cobern, MD, MPH, is a board-certified pediatrician, specialized in preventive medicine, and is a fellow of the ABC News Medical Unit. Justin Berger, reporter with WLOS, an ABC News affiliate in Asheville, North Carolina, contributed to this report.
(NEW YORK) — Taking a daily multivitamin supplement may improve memory and slow cognitive decline in aging adults, according to a new study.
The results could have major implications for the millions of Americans who are suffering from dementia and Alzheimer’s disease.
The study, published Thursday, is the third in a series conducted under the COcoa Supplement and Multivitamin Outcomes Study (COSMOS), a large, nationwide clinical trial testing cocoa extract and multivitamin supplements to see if they can improve cognition and decrease the risk of Alzheimer’s.
In two prior studies, the group found daily multivitamins did have a positive effect on cognition. The current study combines a study of more than 500 participants with meta-analysis of data from more than 5,000 participants.
“Cognitive decline is among the top health concerns for most older adults, and a daily supplement of multivitamins has the potential as an appealing and accessible approach to slow cognitive aging,” first author Chirag Vyas, an instructor in investigation in the department of psychiatry at Massachusetts General Hospital (MGH), said in a statement announcing the study.
For the first part of the study, researchers administered in-person cognitive assessments to 573 people. The results, published the American Journal of Clinical Nutrition, showed that a daily multivitamin improved memory and cognition over two years, compared to a placebo.
Those who took multivitamins displayed memory that was equivalent to someone nearly five years younger than they and had cognition equivalent to someone who was two years younger.
Additionally, statistically significant benefits were seen in improvements for episodic memory – that is, the capacity to recall a memory – but not for executive attention, which is the ability to block out distractions and focus on a task.
The team also conducted a meta-analysis based on the three separate studies, with non-overlapping participants, and similarly found that taking a multivitamin showed benefits for memory and cognition.
“These findings will garner attention among many older adults who are, understandably, very interested in ways to preserve brain health, as they provide evidence for the role of a daily multivitamin in supporting better cognitive aging,” said Dr. Olivia Okereke, senior author of the report and director of geriatric psychiatry at MGH, in a statement.
There are currently an estimated 6.7 million people in the U.S. living with Alzheimer’s disease and related dementias, a number that is expected to rise to 14 million by 2060, according to the Centers for Disease Control and Prevention (CDC).
Previous research has already shown that the risk of dementia can be slowed by maintaining a healthy lifestyle, including controlling high blood pressure, diabetes, obesity and depression. Cutting down on smoking, refraining from binge drinking, and getting plenty of physical exercise, may also improve brain health, according to the CDC.
The new study did have limitations, including that the multivitamin used was the Centrum Silver brand, meaning other multivitamin brands may not produce the same results. It’s also unclear what particular vitamins in the multivitamin itself contributed to the positive effects.
Additionally, 98% of participants in the study were white, so the new study’s results may not be generalizable to the non-white population.
