Health

(NEW YORK) — For at least a decade, Chris Van Bibber had been prevented from donating blood.

The 35-year-old from Salt Lake City, Utah — who is openly gay — was restricted due to rules set in place by the U.S. Food and Drug Administration (FDA) that did not allow sexually active gay men from donating.

However, this past May, the FDA dropped all restrictions specific to gay and bisexual men donating blood, moving to a new blood donation risk assessment tool that is the same for every donor regardless of how they identify, which rolled out in August.

This meant that Van Bibber was able to make history as he donated blood at the American Red Cross Blood Donation Center in his home city.

“To sit back in that chair and to go through the questionnaire beforehand, and it was just — I felt so much excitement and so much relief that we were finally here,” Van Bibber told ABC News. “I just felt like I was finally able to do my part and it’s a small thing to do that can make such a big difference.”

The new policy is one that public health experts and gay rights activists said had been a long time coming.

Ban on gay and bisexual men donating

In the early days of the HIV/AIDS epidemic, blood donations were not able to screen for HIV, which led to some cases of HIV via transfusion. This led to the FDA instituting a lifetime ban on gay and bisexual men from donating blood as well as women who have sex with men who have sex with men.

“That was really based not on an individual person’s risk, but more so on belonging to a particular group and some of that, at the initial onset, you could say was based on what we were seeing with regard to the impact of HIV on specific communities, namely, gay and bisexual men,” Ayako Miyashita Ochoa, an adjunct professor at the UCLA Luskin School of Public Affairs, told ABC News.

“We quickly got to a place where we were able to test all blood donations universally for HIV. That policy became outdated…and yet we did not see a change in the policies related to this permanent ban or permanent deferral,” she continued.

In 2015, the blanket ban was repealed but the FDA placed restrictions that men who have sex with men could donate if they were abstinent from sex for at least one year. In 2020, this was shortened to a period of 90 days of abstinence.

Scientists and advocates argued that not having policies that backed science was discriminating.

“I think it’s safe to say that the policy was so incredibly blunt,” Miyashita Ochoa said. “And it was so group-based, identity-based specifically, that it was a tool for furthering stigma and discrimination.”

‘It felt very invasive’

For Van Bibber, the desire to donate blood is partly due to family history. His mother, Sheri, suffered a life-threatening medical complication when he was born and needed a blood donation to save her life.

Van Bibber said he grew up understanding the significance of blood donation, especially because his blood type is O-negative and can be used in transfusions for any blood type.

Sheri works for the Red Cross organizing blood drives so his family would donate regularly. However, he said he felt like an outsider compared to the rest of his family who was able to donate while he wasn’t.

“It felt very limiting and very invasive of my personal life that I wouldn’t be able to donate or give back in the way that I wanted to,” Van Bibber said. “Donating blood and knowing the importance of that has been a part of our family for since I’ve been alive and so to not be able to participate, not be able to do my right in giving back, it was certainly discerning.”

Blood donation rule change

This year, the FDA announced it would no longer be issuing blanket bans due to sexual orientation and instead screen potential donors on their risk of contracting and transmitting HIV, with the policy going into effect in August.

At the time, the federal health agency said it would use “gender-inclusive, individual risk-based questions” without compromising “the safety or availability of the blood supply.”

Questionnaires ask all donors about new or multiple sexual partners in the past three months. Those who have had a new sexual partner or multiple partners in the past three months and a history of anal sex during that time period will be deferred. Those taking medications to treat or prevent HIV infection will also be deferred. The new blood donation risk assessment is the same for every donor regardless of how they identify.

It follows several other Western countries that have recently dropped bans or eased restrictions including the United Kingdom, France, Greece and the Netherlands.

Van Bibber said when he first heard the FDA was considering making the policy change, he was initially wary, but he was excited when it was made official.

“I was a little leery just because I wanted to know, how are they going to make that change and is it truly going to be inclusive and how are they going to involve everybody?” he said. “And as it finally rolled out, and I read the requirements before I went to go donate, I sat there, and I’m like, ‘This is how we do it. This is absolutely the first step to take, and science is going to keep working with us and it’s only going to go up from here.'”

Experts said this new policy focuses on individual risk, taking into account that many donors are monogamous, test HIV negative and practice safe sex.

“I think that the individual risk-based assessment now gives us a chance to step away from sort of blanket decisions around the risks related to donation,” Miyashita Ochoa said. “I think that we are moving to a place where our policies are reflecting better the science and certainly our expectations as a society to not discriminate.”

Experts are also hopeful that more donors will help address the blood supply. On Sept. 11 of this year, the American Red Cross declared a national blood shortage, stating the blood supply level had dropped nearly 25% since early August.

While blood donations have increased since then, it can take weeks for levels to rebound, the Red Cross said.

More work to be done

Van Bibber said the response from the LGBTQ community has been positive with people coming forward to donate who didn’t realize they were now eligible or sharing their own first-time donation experience.

However, he and others say there is more work to be done. One way to make blood donation even more inclusive would be to expand eligibility to those on a medication called PrEP (pre-exposure prophylaxis, which is a daily pill containing two medications that prevent HIV-negative patients from being infected, they said.

“While we definitely don’t want any donors to stop taking their medication because it’s important for HIV prevention and treatment, but more data is needed to understand how these medications impact testing and eligibility,” Dr. Baia Lasky, a divisional chief medical officer with the American Red Cross, told ABC News.

Miyashita Ochoa said she hopes the risk assessment convinces more people not only to reduce stigma but encourage more people to donate.

“These questionnaires are intended to keep our blood supply safe and so while you may feel some discomfort being asked about your sexual health risks, we have to maintain the safety of our blood supply,” she said.

“So please support this effort to move towards this individual risk-based assessment and understand that beyond just addressing stigma and discrimination, this is about education. And this is about an opportunity to participate in a more just in a more right scientific assessment of risk. We can all do our part,” she added.

ABC News’ Sony Salzman contributed to this report.

 

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(LOS ANGELES)– California will welcome the new year by becoming the first state to offer health insurance for all undocumented immigrants.

Starting Jan. 1, all undocumented immigrants, regardless of age, will qualify for Medi-Cal, California’s version of the federal Medicaid program for people with low incomes.

Previously, undocumented immigrants were not qualified to receive comprehensive health insurance but were allowed to receive emergency and pregnancy-related services under Medi-Cal as long as they met eligibility requirements, including income limits and California residency in 2014.

In 2015, undocumented children were able to join Medi-Cal under a bill signed by then-Gov. Jerry Brown. In 2019, Gov. Gavin Newsom signed into law an expansion of full-scope Medi-Cal access for young adults ages 19 through 25, regardless of citizenship or immigration status. Access was then further expanded to allow older adults aged 50 and older to receive full benefits, also regardless of immigration status.

The final expansion going into effect Jan. 1 will make approximately 700,000 undocumented residents between ages 26 and 49 eligible for full coverage, according to California State Sen. María Elena Durazo.

“This historic investment speaks to California’s commitment to health care as a human right,” Durazo said in a statement in May.

“In California, we believe everyone deserves access to quality, affordable health care coverage – regardless of income or immigration status,” Gov. Newsom’s office said in response to an ABC News request for comment. “Through this expansion, we’re making sure families and communities across California are healthier, stronger, and able to get the care they need when they need it.”

About 50% of undocumented immigrant adults in America report being uninsured, compared to just 8% of U.S.-born citizens, according to the health policy research nonprofit KFF, due to undocumented adults being more likely work jobs that don’t provide health benefits, as well as facing eligibility restrictions for federal programs.

Additionally, undocumented immigrants who are eligible may face other barriers, including confusion about eligibility, language challenges and fear, KFF said.

This is despite low-income undocumented immigrants in California being about as likely as those currently enrolled in Medi-Cal to have at least one chronic condition, according to research conducted by the Public Policy Institute of California (PPIC), a nonprofit research institution.

Undocumented immigrants are also about as likely to receive preventive services, such as the flu shot, and older undocumented immigrants are about as likely to receive age-appropriate health services such as cancer screenings and the shingles vaccine, at rates similar to Medi-Cal patients, the PPIC found.

The California Health and Human Services Agency has committed $835.6 million in 2023-24 and $2.6 billion annually thereafter to expand full-scope Medi-Cal eligibility to all income-eligible adults, regardless of immigration status.

California’s plan to expand coverage has not been without its detractors. The California Senate Republican Caucus criticized the move in an analysis of the 2022-23 governor’s budget.

“Medi-Cal is already strained by serving 14.6 million Californians – more than a third of the state’s population. Adding 764,000 more individuals to the system will certainly exacerbate current provider access problems,” the caucus wrote last year.

When California expanded health care coverage in 2019 to include undocumented young adults, then-President Donald Trump blasted the plan, calling it “very unfair to our citizens.”

“If you look at what they’re doing in California, how they’re treating people, they don’t treat their people as well as they treat illegal immigrants,” Trump told reporters at the time. “So, at what point does it stop? It’s crazy what they’re doing. It’s crazy. And it’s mean, and it’s very unfair to our citizens.”

However, studies have shown that undocumented immigrants use fewer healthcare resources than do non-immigrants.

Gov. Newsom’s office did not immediately reply to ABC News’ request for comment on the latest Medi-Cal eligibility expansion.

 

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(NEW YORK) — From new vaccines to the first drugs of their kind for hard-to-treat disorders, 2023 has been a year full of medical breakthroughs.

They offer opportunities for people to protect themselves from diseases, slow down the effects of others and even incorporate artificial intelligence into cancer diagnoses.

Here are seven of the biggest innovations in the health and science space this year:

New RSV vaccines and immunizations

For the first time ever, after years of setbacks, there are multiple vaccines and shots available for several different groups to prevent RSV.

For adults over age 60, who are at higher risk for serious complications from RSV because immune systems weaken with age, the U.S. Food and Drug Administration (FDA) approved two vaccines.

“So much focus is placed on flu and now COVID. but, each year in the U.S., we see tens of thousands of older adults hospitalized from RSV, thousands die from RSV complications,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News contributor.

“It still has significant public health consequences for those that are most vulnerable, and so now having a high efficacy vaccine is really a tremendous breakthrough for the last year and I think will have significant public health benefit for years to come,” he added.

The FDA also approved a maternal RSV vaccine, which is given to pregnant mothers in the third trimester between 32 weeks’ and 36 weeks’ gestation and is designed to pass antibodies to babies in the womb. It can provide protection from severe illness through the first six months of life.

Lastly, for babies under 8 months old, there are two monoclonal antibody shots available. Monoclonal antibodies are laboratory-made proteins that mimic the body’s ability to fight off pathogens. They are different from vaccines, which stimulate the immune system.

1st CRISPR gene-editing technique to treat sickle cell

Earlier this month, the FDA approved two gene therapies to treat sickle cell disease (SCD), including the first CRISPR gene-editing therapy.

SCD is a genetic condition in which red blood cells have a crescent, or sickle, shape, causing them to be hard and sticky.

“It is a disease that really touches every organ in the body,” Dr. Shari Azar, medical director of the Comprehensive Sickle Cell Disease Treatment Center at Massachusetts General Hospital, told ABC News. “A quarter of our patients will have had a stroke by the time they’re in their 40s. Many of our patients will have had their first joint replacement by the time they’re in their 30s. Many others will have had their first heart attack in their 20s.”

“If the disease goes unchecked, it can lead to blindness, it can lead to dialysis dependence and most of our patients may not see their 45th or 50th birthday,” he continued.

One of these therapies, Lyfgenia, uses a piece of a virus to deliver a gene for fetal hemoglobin, which prevents blood cells from sticking together and constricting blood flow, which is delivered back into the patient.

“From a scientific and medical standpoint, both of these therapies aim to do the same thing, they just do it in a slightly different way,” Azar said. “So, the important thing to emphasize here is that these are not a cure for sickle cell disease. The patients will still have sickle cell disease on the other side of the intervention. The hope is that they will just have a milder form of the disease, where they can see a lot less pain and hopefully fewer complications and hopefully even a longer life.”

Over-the-counter birth control pill

In July, the FDA approved the first over-the-counter birth control pill, meaning it can be sold without a prescription.

Called Opill by French drugmaker HRA Pharma and its parent company Perrigo, public health experts have said it will broaden birth control access for millions of people in the United States.

Opill is a progestin-only pill — sometimes called the “minipill”, meaning it doesn’t contain estrogen like combination birth control pills. Doctors say progestin-only pills pose fewer medical risks than combination pills.

The drug is expected to appear on shelves at convenience stores, grocery chains and online in early 2024.

Scientists pinpoint possible cause of morning sickness

Morning sickness is an extremely common early symptom of pregnancy, with up to 80% of pregnant women experiencing it in the first trimester — and now researchers believe they have discovered the cause.

A team mainly from the U.S., U.K. and Sri Lanka discovered a link between a hormone called GDF15, produced by the fetus in the placenta, and morning sickness.

Results, published earlier this month in the journal Nature, found women with severe nausea and vomiting and blood levels of GDF15 during the first trimester that were significantly higher compared to women who didn’t experience sickness.

Additionally, women who are more sensitive to the hormone become the sickest, which may explain the small percentage of women who suffer an extreme form of morning sickness hyperemesis gravidarum, which is the leading cause of hospitalization in the early stage of pregnancy and famously experienced by Catherine, Princess of Wales during all three of her pregnancies.

Researchers said the finding could help treat women with morning sickness, especially severe forms, by lowering levels of the hormone during pregnancy.

First drug fully approved by the FDA to treat Alzheimer’s

In the past, Alzheimer’s disease treatment has been marked by several drugs that have failed clinical trials but, in July, the FDA granted full approval for a new drug called Leqembi.

Manufactured by the pharmaceutical companies Eisai and Biogen, it is the first drug of its kind that has shown to slow cognitive decline in early Alzheimer’s patients.

Leqembi works by targeting amyloid beta, the main component of the amyloid plaques found in the brains of Alzheimer’s patients and affects memory and thought. It marks the plaques for clearance by the body’s immune system, which slows Alzheimer’s symptoms.

“It’s a significant milestone in Alzheimer’s disease treatment,” Brownstein said. “It is a very big step in giving individuals suffering from this disease more time, and clinical trials have shown to modestly slow cognitive decline, especially in people with early Alzheimer’s disease, and so by slowing cognitive decline, that drug could provide individuals more time to engage in activities that they enjoy.”

Brownstein noted that there are still questions surrounding the drug’s accessibility. The full approval means Medicare can start covering the cost of treatment for patients, making it more widely available, but that’s for a subset of patients.

“This drug, like many others, requires substantial investment for research and development, and so, because of that, companies use drug pricing to recover the costs associated with developing and bringing these drugs to market,” he said. “Unfortunately, that pricing, that means that this drug will be out of reach for some, and that’s really something that needs to be addressed because of course, this drug should be available to anyone suffering from this disease.”

An mRNA vaccine to treat pancreatic cancer

A research team funded by the National Institutes of Health (NIH) has developed a personalized mRNA vaccine with partners at BioNTech, against pancreatic cancer, one of the deadliest forms of cancer in the U.S.

BioNTech performed gene sequencing on more samples to identify neoantigens — proteins that are unique to cancer cells – that may stimulate an immune response.

In early clinical trials, patients received a drug that inhibits cancer cells from suppressing the immune system, then were given their personalized vaccine split in nine doses over many months.

Eighteen of the 19 patients successfully had vaccines created for them and 16 were healthy enough to receive at least some of the doses, according to the NIH.

About half of the patients saw the vaccine trigger T cells, a type of immune system cell that destroys infected cells, that targeted the specific cancer cells in each patient.

Among the patients who saw the strong immune system response, the cancer did not return after a year and a half of treatment, including chemotherapy. In those who did not have a strong immune system response, the caner retuned within a year, according to results published earlier this year in the journal Nature.

“It’s exciting to see that a personalized vaccine could enlist the immune system to fight pancreatic cancer—which urgently needs better treatments,” Dr. Vinod Balachandran, a surgical oncologist from Memorial Sloan Kettering Cancer Center, said in a statement. “It’s also motivating as we may be able to use such personalized vaccines to treat other deadly cancers.”

AI boosts breast cancer detection rates

Artificial intelligence (AI) has been increasingly used in scientific trials, and a new tool developed this year is helping spot more breast cancer than human screenings.

The tool, named Mia and developed by Imperial College London and Kheiron Medical Technologies detected 13% more early breast cancers.

Across the two pilot phases and the live roll out, Mia detected 24 more cancers and led to 70 more women being recalled, according to a release from Imperial College London.

Of the women who were recalled, additional cancers were found, which raised cancer detection rates by 13%.

“These results have exceeded our expectations,” Dr Ben Glocker, a professor in machine learning for imaging at ICL, said in a statement. “These results have exceeded our expectations. Our study shows that using AI can act as an effective safety net — a tool to prevent subtler signs of cancer falling through the cracks. Seeing firsthand that the use of AI could substantially reduce the rate of missed cancers in breast screening is massive, and a major boost for our mission to transform cancer care with AI technology.”

 

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(NEW YORK) — A health system in Michigan has experienced its second cybersecurity breach this year, affecting more than 1 million patients, according to state officials.

Michigan Attorney General Dana Nessel announced Tuesday there was a breach at HealthEC, a vendor that provides services to Corewell Health’s southeast Michigan properties. The breach exposed patients’ personal and medical information.

HealthEC services is helping to “identify high-risk patients, close gaps in care and recognize barriers to optimal care,” according to a release.

It’s unclear what specific information was exposed but it can include name, address, date of birth, Social Security number, medical diagnoses, mental/physical condition, health insurance information, treatment cost information and billing and claims information, the release said.

Patients affected by the breach had notice letters mailed to them on Dec. 22, according to Nessel’s office.

“Health information is some of the most personal information we have,” Nessel said in a statement. “Michigan residents have been subjected to a surge of healthcare-related data breaches and deserve robust protection. It is critical that the Michigan legislature join the many other states that require companies who experience a data breach to immediately inform the Department of Attorney General.”

Corewell Health said it contacted the attorney general’s office before making a public announcement.

Last month, Corewell Health announced that vendor Welltok, experienced a data breach that led to similar personal and medical information being exposed. More than 1 million patients were impacted.

For anyone affected by the data breach, Nessel’s office recommends steps including changing passwords, contacting one’s bank or credit union and potentially putting a fraud alert on one’s credit file to prevent identify theft.

This is the latest in a series of cyberware attacks and data breaches that have been affecting health system across the U.S.

In Oklahoma, Integris Health — which offers hospitals and primary care clinics across the state — said a data breach were accessed by an unauthorized party at the end of November, according to local ABC News affiliate KOCO 5.

The health system then announced on Christmas Eve that patients were receiving messages from a group claiming responsibility for the data breach and threatening to expose the information on the dark web unless they received payment.

Capital Health — which operates hospitals in Trenton and Pennington as well as primary care offices across New Jersey — said last month it had been experiencing network outages that it believes was a “cybersecurity incident,” but was unsure if any personal information had been exposed.

Additionally, hospitals run by Ardent Health Services — including two in New Jersey — were forced to divert ambulances to other area hospitals and cancel some non-elective procedures after the organization discovered a ransomware attack on Thanksgiving Day.

 

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(NEW YORK) — A woman who was born with a rare condition known as double uterus gave birth to two twin girls whom she carried in each of her uteruses during her pregnancy.

Kelsey Hatcher of Dora, Alabama, delivered one girl on Tuesday, and another on Wednesday following 20 hours of labor, according to the University of Alabama at Birmingham.

“Our miracle babies were born! They decided they were rare enough statistically that they should just go ahead and have their own birthdays too,” Hatcher wrote on Instagram.

Her first baby, named Roxi, was delivered vaginally at 7:45 p.m. on Dec. 19, weighing 7 pounds 7 ounces, the press release said. Meanwhile, her second baby named Rebel was delivered via c-section a little over 10 hours after her sister was born, on Dec. 20, at 6:10 a.m. weighing 7 pounds 3.5 ounces.

In a press release, Hatcher, who was already a mother of three before her fourth pregnancy with the twins, credited the assistance from UAB while announcing the birth of her two girls.

“Bringing our two healthy baby girls into this world safely was always the goal, and UAB helped us accomplish that,” Hatcher said in the release. “It seems appropriate that they had two birthdays, though. They both had their own ‘houses,’ and now both have their own unique birth stories.”

“After such a long and crazy journey, it meant the world to see both of my girls together for the first time,” Hatcher said, according to the release.

Hatcher was born with two uteruses and two cervixes, a rare condition also known as uterine didelphys, or double uterus. This condition, present in only 0.3 percent of people with uteruses, develops when the reproductive organs form differently in an embryo. People with double uteruses can experience pain, fertility issues, or sometimes no symptoms at all.

The odds of being pregnant at the same time in each uterus are about “1 in a million,” according to Dr. Richard Davis, a maternal and fetal medicine specialist at the University of Alabama at Birmingham’s Women & Infants Center, where Hatcher was being treated.

This was the first of her four pregnancies with her husband Caleb in which she carried one baby in each uterus. Speaking to “Good Morning America” last month, Hatcher said she had a single baby carried in one uterus in her previous pregnancies with her kids – now ages 7, 4, and 2 that also went full-term, with no complications.

While Hatcher did not carry both babies in one uterus like a typical twin pregnancy, Davis said in a press release, “it is safe to call the girls fraternal twins.”

“At the end of the day, it was two babies in one belly at the same time. They just had different apartments,” Davis added.

 

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(NEW YORK) — Exemptions for immunizations required in school are on the rise in the U.S., leading to concerns among medical experts that diseases like measles could soon make a comeback in many states.

In November, the Centers for Disease Control and Prevention reported that exemptions for immunizations required in school is the highest ever recorded in U.S. history – increasing to an average 3.0% in the 2022-2023 school year, with 10 states now reporting exemptions exceeding 5%. This leaves both vaccinated and unvaccinated children vulnerable to disease outbreaks including measles, experts say.

“There’s 9 million people in this country who can’t be vaccinated. They depend on those around them to protect them,” Dr. Paul Offit, a virologist and vaccine advocate, told ABC News.

In his upcoming book, “Tell Me When It’s Over: An Insider’s Guide to Deciphering Covid Myths and Navigating Our Post-Pandemic World,” Offit gives a historical account of the anti-vaccination movement in the U.S. and explains the rise of non-medical immunization exemptions over time and how these trends relate to the nationwide pushback against COVID-19 vaccine mandates.

ABC News spoke with Offit and other doctors who work in infectious diseases and immunization research to explore what’s driving these trends and understand what the future may hold if immunization exemptions keep rising.

“We mandated vaccines – for the first time in my lifetime at all levels,” Offit said. “And that really upset people … people really pushed back, they were angry.”

Since the start of the COVID-19 pandemic, lawmakers have introduced hundreds of pieces of legislation aimed at rolling back vaccine mandates, largely COVID-19 mandates, but some changes have also impacted childhood immunization requirements.

These legislative efforts largely prevented many statewide COVID-19 vaccine mandates, according to the National Academy for State Health Policy. Since the pandemic began, no state has passed legislation to newly allow a philosophical or religious exemption in the few states that only allow medical exemptions, according to the National Conference of State Legislatures. But in some states, new laws or court rulings have made getting routine vaccines harder.

In July 2021, pushback against COVID-19 vaccines started to spill over to routine childhood immunizations in Tennessee. Efforts to vaccinate more of the state’s population against COVID-19, including teenagers, led to the firing of the state’s medical director, Dr. Michelle Fiscus, and temporarily halted all immunizations to kids and teens in the state. As of May 2023, Tennessee law now requires written informed consent by a parent or legal guardian for any person under the age of 18 to receive any vaccine.

Critics worry this added step of written consent creates an unnecessary barrier that may prevent many kids from getting the shots they need, including some of the most vulnerable kids such as cancer patients who often need extra doses of routine vaccines to mount a full immune response.

Dr. Diego R. Hijano, an infectious disease specialist at St. Jude Children’s Research Hospital in Memphis, Tennessee, told ABC News that this new law doesn’t make vaccines safer, it just makes it harder for parents to agree to vaccines and harder for providers to administer them on time.

“We still do all the things we need to do before the law is implemented. It’s just that this step has delayed us being able to offer all these vaccines under the new law because we’ve had to create these consents and have all this [new process] in place,” Hijano said.

Mississippi is not known for being a national leader in public health outcomes – holding higher rates of obesity, diabetes, heart disease, and infant and maternal mortality than national averages – however, the state’s childhood vaccine rates are an exception.

The CDC reports that Mississippi still holds the highest proportion of vaccinated kindergarteners in the country, but health officials worry these high rates may soon be threatened by the recent court order that went into effect in July 2023 requiring the health department to allow religious exemptions, the Associated Press reported.

“The federal [Covid-19 vaccine] mandates were not we received in many places like ours, and some of that bled over into any type of [vaccine] mandate,” Dr. Daniel Edney, state health officer for the Mississippi Department of Health told ABC news. “This is a situation where it’s extremely frustrating, as the chief public health official and physician, to have 40 years of public health policy and science overruled by two attorneys who don’t [have public health expertise].”

Edney says that Mississippi typically has about 500 medical exemptions a year, but now, they have had over 2,100 non-medical exemptions since July and expect to pass 3,000 total exemptions before the year is over. Currently and concerningly, Edney says non-medical exemptions have been concentrated in a handful of counties in the state that include Hinds County, Ridgeland County, Lamar County, and in some pockets on the Gulf Coast.

Vaccine-preventable outbreaks like measles, polio, and whooping cough are far more likely in areas that have concentrated clusters of unvaccinated people, and since no vaccine is 100% effective, people who are vaccinated can also get sick.

Edney said Mississippi has been fortunate not to need the same level of staffing and resources dedicated to respond to vaccine-preventable disease outbreaks like other states more prone to these outbreaks have, but health officials say that has to change now.

“We have to invest in these investigation [resources] for the outbreaks that will come at some point down the road,” Edney said.

Measles cases drove California to tighten vaccine restrictions

Doctors worry that the only thing that will drive this rising trend of non-medical vaccine exemptions in the opposite direction will be disease outbreaks that predominantly affect young children, which was seen in California after there was a large measles outbreak that began at Disneyland from December 2014 to February 2015.

Dr. Dean Blumberg, professor and chief of pediatric infectious diseases at UC Davis Children’s Hospital explained to ABC News that California previously allowed both philosophical and religious vaccine exemptions, but now has some of the strictest vaccine laws in the country through state legislation passed in 2016 and 2019, which only allows medical exemptions that the health department reviews.

“I think vaccines are always at some level a victim of their own success,” Offit said. “It just scares me that the only way we’re going to once again appreciate the importance of vaccines is to, at some level, experience some of these diseases again. I just wish we could do something to avoid that.”

What parents need to know

Vaccine preventable diseases can be deadly, which is why vaccines were developed to prevent them. Globally every year, 134,200 kids still die from measles, according to the CDC. The agency also estimates that failure to eradicate polio could cause poliovirus to reappear around the world with an estimated 150,000-200,000 new cases expected every year within 10 years.

“For all these diseases, there’s reasons that a lot of effort was made to develop these vaccines and deliver the vaccine. And for each individual one, I think it’s important for parents to know that if their kids are not vaccinated there are potentially very serious consequences,” Blumberg said.

Blumberg encourages healthcare providers to discuss the importance of vaccines and the consequences of not getting a child vaccinated as much as possible to parents and caregivers. “Lately, what I found is most useful is talking about each individual vaccine and talking about why it fits into the vaccine schedule, where it is, and what the consequences are of having children vulnerable to these vaccine preventable diseases,” Blumberg said.

Doctors also point out that a rate of 3% of immunizations exemptions still means 97% of kids in school are getting vaccines on time.

“The vast majority of parents are still vaccinating their kids according to the recommended schedule,” Dr. Sean O’Leary, chair of the American Academy of Pediatrics Committee on Infectious Diseases and professor of pediatrics at the University of Colorado Anschutz Medical Campus/Children’s Hospital Colorado, told ABC News.

O’Leary points out that while vaccines have been used as political tools in recent years, most parents care more about what their medical provider says than any politician. Talking to parents at health visits about the importance of vaccines is important.

“The vast majority of people really are not operating in the political arena, when they’re when they’re thinking about their own children,” O’Leary said. “[Parents are] operating in what is best for my child.”

Dr. Jade A Cobern, MD, MPH, is a board-certified pediatrician specialized in general preventive medicine and is a member of the ABC News Medical Unit.

 

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(NEW YORK) — As Ozempic and other drugs used for weight loss continue to soar in popularity, the U.S. Food and Drug Administration (FDA) has issued a new warning for consumers.

On Thursday, the FDA announced it had seized “thousands of units” of counterfeit Ozempic from the U.S. drug supply.

The agency warned consumers, as well as wholesalers, retail pharmacies and health care workers, to check Ozempic products, noting, “Some counterfeit products may still be available for purchase.”

Ozempic, made by Novo Nordisk, is approved by the FDA to treat Type 2 diabetes, but some doctors prescribe the medication “off-label” for weight loss. Ozempic is an injectable medication that is typically prescribed to be taken once per week.

The active ingredient in Ozempic is semaglutide, a medication that also was initially approved for Type 2 diabetes but which the FDA has since approved for use in weight management under the brand name Wegovy. Like Ozempic, Wegovy is also manufactured by Novo Nordisk.

In its warning, the FDA said consumers and healthcare workers should not “distribute, use, or sell” one-milligram injectable Ozempic products with the lot number NAR0074 and serial number 430834149057.

In addition, the FDA said that needles on the affected products are also counterfeit.

“Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products,” the agency said. “Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.”

According to the FDA, there have so far been five “adverse events” from the affected products. The agency said none of events are “serious” and noted the reported complications have been consistent with the standard side effects of drugs used for weight loss, including Ozempic, which include nausea, vomiting, diarrhea, abdominal pain and constipation.

The agency said it is continuing the investigation and is working with Novo Nordisk to “identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the U.S.”

Consumers and healthcare workers are asked to report adverse events or side effects from Ozempic use via the FDA’s website.

Consumers can also report suspected counterfeit products to their state’s FDA consumer complaint coordinator or directly to the FDA via their website. You can also call Novo Nordisk about Ozempic concerns at 1-800-727-6500.

The FDA’s warning about counterfeit Ozempic comes nearly seven months after the agency warned consumers that off-brand forms of drugs being used for weight loss could be unsafe.

The agency issued the warning in June as many people have reported turning to compounding pharmacies to get cheaper doses of semaglutide. Without insurance coverage, the cost of medications like Ozempic can run more than $1,000 a month.

Compound versions of drugs are made for individual patients using raw ingredients. The FDA said at the time it had received reports of adverse events after people administered semaglutide that was made by a compounding pharmacy. The FDA did not specify the number of reports, nor what the adverse events were.

“Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality,” the FDA said in a new safety warning this week.

 

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(NEW YORK) — A record number of Americans have signed up for health insurance through Affordable Care Act (ACA) marketplaces this year, according to early data published by the Biden administration this week.

More than 15 million people have enrolled in 2024 coverage under the ACA — often called by its nickname, Obamacare — as of Dec. 15, which is 33% higher than the roughly 11 million who did so last year.

This figure includes those who have bought insurance through state-based marketplaces or at HealthCare.gov, the website run by the federal government.

The Department of Health & Human Services said it expects more than 19 million to enroll by the deadline of 5 a.m. ET on Jan. 17, 2024 — about 7 million more people than when President Joe Biden took office. Their coverage will begin on Feb. 1.

On Dec. 15 alone, more than 745,000 enrolled in plans on HealthCare.gov. Health officials said it was the highest number of visitors ever recorded since the portal rolled out in 2013.

“Millions of Americans signing up for health care coverage under the Affordable Care Act is good news. It means more Americans have the peace of mind of knowing that going to the doctor won’t empty their bank account,” HHS Secretary Xavier Becerra said in a statement. “The Biden-Harris Administration will continue working to expand health care coverage and lower prescription drug costs, so taking care of your health is not a luxury.”

HHS did not immediately reply to ABC News’ request for comment.

One reason for increased enrollment is likely due to millions of Americans losing Medicaid, a government program that provides health insurance for adults and children with low incomes.

During the COVID-19 pandemic, when the government issued its two emergencies, states were not allowed to delist people so nearly 95 million people received coverage through Medicaid by the end of March 2023, according to nonprofit KFF.

States were also given additional federal funding for the last three years to provide continuous Medicaid coverage, ensuring no one lost health care amid the throes of COVID-19.

When the Biden administration ended both the COVID-19 national emergency and public health emergency on May 11 of this year, states began reviewing their rolls to see if enrollees were still eligible for government-funded health care.

More than 13.3 Medicaid enrollees have been removed as of Dec. 20, according to KFF. The nonprofit believes this is actually an undercount due to lags in state data.

Another reason for the increased enrollment could be the number of people who became uninsured under former President Donald Trump’s administration. Gallup data shows that in 2019, 13.7% of adults were without health insurance.

While this is lower than the percentage of Americans that were without health insurance before the ACA, the Trump administration ended cost-sharing reduction, rolled back the individual mandate penalty and cut back on enrollment outreach, according to Gallup.

Trump has vowed to replace the ACA with his own health care plan if elected president again.

Despite the record enrollment, more than 25.6 million non-elderly Americans were uninsured in 2022, according to KFF. HHS says the Biden administration “continues to make increasing coverage a top priority” through provisions in the Inflation Reduction Act that result in savings and a competitive marketplace.

ABC News’ Cheyenne Haslett contributed to this report.

 

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(NEW YORK) — Respiratory virus season has kicked off in the United States as Americans get ready to travel to celebrate the holidays.

Flu and COVID-19 emergency department visits and hospitalizations are continuing to increase throughout the United States, while vaccination rates lag, according to data from the Centers for Disease Control and Prevention.

Respiratory syncytial virus, or RSV, levels are still elevated in many areas of the country, although CDC data shows the weekly percent of total emergency department visits associated with RSV appears to be trending down after hitting its peak around Thanksgiving.

“[This is] good, so we don’t have necessarily peaking of all of these simultaneous threats at the same time,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital, and an ABC News contributor. “At the same time, we are seeing a jump in COVID, which is not ideal because a new COVID variant, aligning with holiday travel and gatherings, is unfortunately [a] recipe for additional illness.”

On Tuesday, the World Health Organization listed the JN.1 COVID variant — a subvariant of the omicron variant — as a “variant of interest.” It is currently estimated to account for 21% of new cases in the U.S., according to the CDC.

There is currently no evidence to show that JN.1 causes more severe disease or that currently available treatments and vaccines are ineffective against the variant.

Countries in the midst of winter, such as the U.S., could see an increase in respiratory infections, the WHO said in a statement.

“That will unfortunately, over time, create some pressure on our health system,” Brownstein said.

Some health systems in the U.S. are reinstating mask mandates due to the rise in respiratory viruses as they deal with an influx of patients.

UW Health, which primarily serves Wisconsin and northern Illinois, posted on X, formerly known as Twitter, on Tuesday that all staff, patients and visitors will be required to wear masks for patient interactions in clinic settings “due to expected seasonal increase and sustained high volume of respiratory illness.”

Additionally, on Wednesday, masks became required at all University of Pittsburgh Medical Center facilities, according to Pittsburgh ABC affiliate WTAE. UPMC said cases would be monitored and protocols adjusted as necessary.

CDC Director Dr. Mandy Cohen recently told ABC News that, for the most part, pediatric hospitals have told the federal health agency they’ve been able to manage treating patients.

Brownstein said more hospitals may reinstate mask mandates in the coming weeks if cases do, in fact, rise following the holidays, but echoed Cohen’s comments that hospitals have become better equipped to anticipate potential surges of patients.

“Hospitals have done a lot more to understand how to deal, especially with a new element of COVID as part of the seasonal mix,” Brownstein said. “So, there is a lot more planning, forecasting and employee safety protocols, and it can ensure that hospitals are running at maximum capacity to handle a potential influx of patients.”

Brownstein said he recommends the same mitigation measures that health officials have throughout the pandemic for those who are traveling or hosting for the holidays, including proper hand hygiene, being up to date on vaccines, improving ventilation and potentially masking, based on your personal risk level.

“Each individual household gathering is going to have a different mix of high-risk groups and vulnerable individuals, and we want to prepare to make sure — especially for those that are potential, serious risk and complications — that we’re managing to overall reduce that risk,” he said. “This is a playbook that we have gone to many times before, and so even though the impact of COVID isn’t anywhere near where it used to be, everyone has the right tools to help reduce any potential risk of these respiratory pathogens heading into the holidays.”

ABC News’ Youri Benadjaoud contributed to this report.

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(NEW YORK) — With the holidays approaching, many are looking forward to feasting with family and friends. Gatherings often bring a lot of homemade favorites — steaming turkey, glistening ham, tangy cranberry sauce and creamy eggnog. While preparing dishes, it’s important to follow safe cooking guidelines and limit the risk of food poisoning.

When it comes to serving dishes and dealing with leftovers, most people want to know what’s safe to eat and what needs to be tossed.

The New York State Departments of Agriculture and Markets recently issued recommendations for enjoying safe holiday feasts. The most important things to consider to avoid foodborne illness are safe storage, thawing and preparation.

When returning home with a fresh grocery haul, be sure to store away perishables as soon as possible. Leaving refrigerated and frozen food products out for extended periods of time allows for the growth of bacteria that can cause illness. Refrigerators should be set to 40°F or lower, and freezers should be set no higher than 0°F, per the FDA.

This time of year, many people purchase canned goods for cooking and to donate to food pantries. Experts recommend keeping these products in cool, dry spaces until opening and taking particular care not to leave them out on stovetops.

“Once that can is open, you really need to eat or refrigerate the contents after two hours,” says Dr. Donald Schaffner, PhD, a professor in the Department of Food Science at Rutgers University.

When thawing frozen meats, food safety specialists agree that the best method is to use the refrigerator or microwave just before cooking. Thawing meat in the refrigerator “makes sure that the food stays at a safe temperature during the thawing process,” according to Dr. Schaffner.

“As a piece of meat thaws, you may get juices running out of that piece of meat” that may contain different types of bacteria, creating a source of contamination. Submerging in hot water can also lead to the spread of bacteria into pots and bowls.

Washing hands when preparing food may seem obvious, but experts note that there is always a risk of cross-contamination when using the same knives and cutting boards for raw meat and other foods. Taking the time to wash these items with soap and hot water after handling raw meat can go a long way toward keeping the rest of a holiday feast safe to eat.

Safe cooking should also include a meat thermometer. A general rule of thumb is to cook to a minimum internal temperature of 140°F. Pork should be cooked to 150°F, ground beef to 160°F and poultry and leftovers to 165°F, per the Departments of Agriculture and Safety.

Eggs can be a forgotten source of contamination as well. According to guidelines from the Centers for Disease Control and Prevention, eggs need to be cooked thoroughly and raw forms should definitely be avoided. That means waiting until the cookies finish baking and not dipping into the raw batter.

As far as enjoying holiday cheer, Dr. Schaffner suggests, “The safest eggnog is the kind you buy from the grocery store, premade and pasteurized. If you’re going to make your own eggnog with raw eggs, you need to cook that eggnog.” Alcohol does not guarantee purification from salmonella, so those making it from scratch should follow a recipe that involves cooking, Schnaffer added.

Chris Medrano, MD, is a resident physician in Chicago and a member of the ABC News Medical Unit.

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