What to expect from FDA panel on boosters for Moderna, Johnson & Johnson vaccines

What to expect from FDA panel on boosters for Moderna, Johnson & Johnson vaccines
What to expect from FDA panel on boosters for Moderna, Johnson & Johnson vaccines
Teka77/iStock

(WASHINGTON) — An independent FDA advisory panel on Thursday and Friday is set to discuss and vote on whether to authorize Moderna and Johnson & Johnson Covid-19 vaccine boosters for those 18 and older.

The outside experts will also consider new data from the National Institutes of Health on the potential benefits of mixing and matching vaccines for booster shots.

Early results from the highly anticipated NIH study finds that boosting with a shot different from what people got the first time appears to be safe and effective.

The non-peer reviewed study evaluated all three vaccines — Pfizer, Moderna and J&J — finding that no matter the booster, all study participants saw a “substantial” uptick in antibody levels after a booster shot.

Though promising, more research is likely needed on mixing and matching. For now, the FDA and CDC are slated to weigh in on whether to authorize additional booster doses of Moderna and Johnson & Johnson shots for those who received the same original vaccine.

This week’s meetings are the first step in a long process: The FDA itself and the Centers for Disease Control and Prevention would both need to sign off on the panel’s recommendations about who should get boosters and when — and the earliest that could happen is the following Friday, Oct. 22.

On Thursday, the panel will discuss and vote on a potential Moderna booster, and hear presentations from both the company and FDA representatives; Israel’s director of public health health will give a presentation about the results of Pfizer booster shots in that country.

The FDA panel will ask questions and debate the benefits versus risks of a Moderna booster and an initial, non-binding vote on the Moderna booster has been scheduled for Thursday afternoon.

On Friday, the panel will discuss and vote on a Johnson & Johnson booster, in addition to hearing NIH’s presentation on mix and match booster data.

Johnson & Johnson’s posted a summary of its research Wednesday, making the argument for a second shot, same dose, roughly six months after the single-shot vaccine.

An initial, non-binding vote on the Johnson & Johnson booster has been scheduled for Friday afternoon.

Once the FDA advisory panel votes on recommendations for each booster, the FDA itself needs to formally amend the current emergency authorization. FDA career scientists are expected to authorize boosters for Johnson & Johnson and Moderna within days of the independent panel’s non-binding vote.

Then, the question goes to CDC’s independent advisory panel of experts. That panel has scheduled a meeting for next Wednesday Oct. 20 and Thursday Oct. 21 to discuss boosters for Moderna and Johnson & Johnson. Those outside experts will weigh in with their recommendations, which are also non-binding.

Once that happens, CDC Director Rochelle Walensky must sign off, which typically happens within 24 hours of the panel’s recommendations.

Copyright © 2021, ABC Audio. All rights reserved.

Biden embraces Trump accords, but struggles with his withdrawal from Iran nuclear deal amid growing threat

Biden embraces Trump accords, but struggles with his withdrawal from Iran nuclear deal amid growing threat
Biden embraces Trump accords, but struggles with his withdrawal from Iran nuclear deal amid growing threat
Official White House Photo by Adam Schultz

(WASHINGTON) — There have been major differences between the administrations of Donald Trump and Joe Biden on foreign policy — not least over the Iran nuclear deal, with Biden officials blaming Trump’s withdrawal for bringing Iran closer to a nuclear weapon today than before.

But even as Biden’s top diplomat warned more starkly than ever about the threat from Iran and the need to salvage the nuclear deal Wednesday, there was some consistency: Secretary of State Antony Blinken embraced the set of key Trump-era deals known as the Abraham Accords.

Those historic agreements saw Israel establish relations with some of its Arab neighbors — starting with the United Arab Emirates and extending, in varying degrees, to Bahrain, Morocco and Sudan.

The deals were controversial in some corners not just because they sidelined the Palestinians and did nothing to address long-simmering tensions there, but also because of the big-ticket incentives Trump offered to sweeten the pot for Arab countries, including selling the most advanced U.S. fighter jet, the F-35, to UAE; recognizing Morocco’s claim to Western Sahara; and even offering to pay the Sept. 11 attacks victims to make legal claims against Sudan go away.

But with Israel’s foreign minister and alternate Prime Minister Yair Lapid and UAE’s Foreign Minister Abdullah bin Zayed Al Nahyan, Blinken heralded the agreements during a meeting at the State Department Wednesday. He announced the two countries, along with the U.S., was expanding the Abraham Accords with two new working groups on religious co-existence and water and energy — and said the Biden administration is looking to add other countries to them, too.

“Normalization is profoundly in the interests of the people in the countries in question and is providing all sorts of new opportunities,” Blinken said during a press conference with Lapid and bin Zayed. “It simply means that people will have a better life, more opportunity, more security, more prosperity.”

So far, that hasn’t been the case for Palestinians. Palestinian leaders were furious that the UAE, Bahrain and others abandoned a decades-old commitment to not recognize Israel until Palestinian aspirations for a state were granted. But Blinken, Lapid and bin Zayed said Israel and UAE’s growing economic and people-to-people ties were an example for what could be possible for the Palestinians, too.

“The more of a successful UAE-Israeli relationship will be, that would not only encourage the region, but also encourage the Israeli people and the Palestinian people that this path is worth not only investing in, but also taking the risk,” said bin Zayed.

Bin Zayed announced he would visit Israel soon “to meet a friend, but also a partner,” he said, smiling over at Lapid, who made a historic visit to Abu Dhabi earlier this year.

“The Palestinians are going to be the most important element of the success of peace in the region. We cannot just talk about peace in the region without the neighbors; the Palestinians and Israelis are not in talking terms to start with,” he added, saying there had been some progress with recent meetings between Israeli ministers and the Palestinian Authority.

For his part, Lapid — who invited bin Zayed to his house and said his wife was ready to cook for him — added that Israel was now focused on making the existing Abraham Accords successful, while working to expand them to other countries, “including ones you don’t think of,” he added with a smile.

He had little to say about the Palestinians, however, adding during his opening statement, “All people are entitled to a decent way of life. This includes of course the Palestinians. Our goal is to work with the Palestinian Authority to ensure every child has that opportunity.”

Blinken reiterated the Biden administration’s support for a two-state solution and called for both sides to “enjoy equal measures of freedom, prosperity, democracy,” But he backed normalization as a way to get there.

“We believe normalization can and should be a force for progress not only between Israel and other Arab countries in the region and beyond, but also between Israelis and Palestinians,” he said.

To pursue that progress, he also made clear the U.S. is “moving forward” with reopening the American consulate in East Jerusalem, which has traditionally served as a de facto embassy to the Palestinians. Israel, which largely has control as host country, has vocally opposed the move, including in comments by Justice Minister Gideon Saar Wednesday, who said Israeli Prime Minister Naftali Bennett agreed, “No way.”
US, Israel weighing ‘alternative plans’ against Iran as nuclear talks remain paused

Beyond that disagreement, there was another critical difference on display Wednesday over the growing threat of Iran’s nuclear program.

Blinken again warned time is running out for salvaging the Iran nuclear deal as Iran continues to expand its nuclear program, with more enriched uranium, enriched at higher levels, using more and more advanced centrifuges.

He once again declined to put a timetable on it, but in perhaps his strongest language yet, said the U.S. and its partners are looking at “every option to deal with the challenge posed by Iran. We continue to believe diplomacy is the most effective way to do that, but it takes two to engage in diplomacy, and we have not seen from Iran a willingness to do that at this point.”

Hours earlier, his special envoy for Iran, Rob Malley, said the U.S. must “prepare” for “a world in which Iran doesn’t have constraints on its nuclear program” — a world without a nuclear deal. The Biden administration is doing that “now in consultation with our partners from the region,” he added during an event with the Carnegie Endowment for International Peace.

To that end, Malley is departing for United Arab Emirates, Qatar and Saudi Arabia on Friday to discuss Iran, State Department spokesperson Ned Price said Wednesday.

Those efforts were echoed in what Lapid said Tuesday after meeting National Security Adviser Jake Sullivan at the White House. The two “discussed the need for an alternative plan to the nuclear agreement,” according to his office.

Both he and Blinken declined to spell out Wednesday what those potential plans may be, but Lapid implied it includes the use of force.

“Secretary of State Blinken and I are sons of Holocaust survivors. We know there are moments when nations must use force to protect the world from evil. If a terror regime is going to acquire a nuclear weapon, we must act, we must make clear that the civilized world won’t allow it,” he said.

When asked later about the use of force, he added, “by saying other options, I think everybody understands here, in Israel, in the Emirates, and in Tehran what is it that we mean.”

But while Blinken said all three of them — along with European partners — agree that Iran must not be allowed to acquire a nuclear weapon, Lapid’s language was even more stark. He urged less patience with waiting for Iran to resume nuclear talks. Those indirect talks between the U.S. and Iran have been on hiatus since June, with Iran’s new government saying it must get its team in position first.

“Iran is becoming a nuclear threshold country. Every day that passes, every delay in negotiations, brings Iran closer to a nuclear bomb. Iran is clearly dragging their heels, trying to cheat the world to continue to enrich uranium, to develop their ballistic missile program,” Lapid said, adding that Israel had not just a “right,” but a “responsibility” to stop Iran from acquiring the bomb.

Blinken did not answer a question about use of force, saying again the Biden administration believes a “diplomatic solution” is best, but adding, “To be very clear, Israel has the right to defend itself, and we strongly support that proposition.”

Other U.S. allies have joined in recent weeks in urging Tehran to resume those talks. The French Foreign Ministry said Wednesday the situation had reached a “crisis and at a critical moment for the future of the nuclear agreement,” blaming Iran for “refusing to negotiate” and creating “facts on the ground that further complicate the return to the JCPOA,” an acronym for the nuclear deal’s formal name.

Enrique Mora, the European Union’s second highest-ranking diplomat who has coordinated those talks, said Wednesday he was traveling to Iran to “raise the urgency to resume #JCPOA negotiations in Vienna. Crucial to pick up talks from where we left last June to continue diplomatic work.”

But in the meantime, the U.S. is urging immediate action on another front — the release of American citizens detained by Iran. Both Blinken and Sullivan met Wednesday with Babak Namazi, whose brother Siamak and father Baquer Namazi have been detained by Iran for six years — to the day — and 5 1/2 years, respectively.

“The Iranian government continues to subject the entire Namazi family to unimaginable abuse. Through it all, the Namazis have shown remarkable courage,” Blinken said in a statement afterward. “The United States is committed to securing Siamak and Baquer’s freedom as soon as possible, as well as that of the other U.S. citizens wrongfully detained in Iran.”

Jared Genser, a lawyer for the Namazis, filed an urgent appeal with the United Nations last week to call for Baquer Namazi’s immediate release so he can have a lifesaving surgery on a major blockage in his right carotid artery.

“My father’s already lost so much precious time. I’m begging Iran to allow him to spend whatever time he has left with his family,” Babak Namazi told reporters last week in an emotional appeal.

Copyright © 2021, ABC Audio. All rights reserved.

Hundreds gather for Miya Marcano’s Celebration of Life ceremony

Hundreds gather for Miya Marcano’s Celebration of Life ceremony
Hundreds gather for Miya Marcano’s Celebration of Life ceremony
cmannphoto/iStock

(COOPER CITY, Fla.) — Hundreds of mourners gathered for an emotional Celebration of Life ceremony for Miya Marcano, the Florida college student who was found dead eight days after her family reported her missing.

Her funeral will take place Thursday afternoon.

Family and friends embraced each other in front of Marcano’s casket, which was painted her favorite color royal blue, during Wednesday’s ceremony at Cooper City Church of God.

Loved ones shared their favorite memories of Marcano and talked about how she enjoyed dancing and celebrating her Caribbean culture.

“It was totally amazing just to be there and to experience the lives that Miya touched in such a short period of time,” family attorney Daryl K. Washington told ABC News.

“Hearing the stories from her friends, strangers and family members talking about how she was such a princess and how she brightened up the room every time she entered. It makes it so hard to accept the fact that this young lady lost her life in such a brutal fashion,” he added.

Marcano’s mother, Yma Scarbriel, is asking that donations be made to the Miya Marcano Memorial Fund, which is supporting and providing resources to families of missing persons while advocating for the protection of students and vulnerable populations, in lieu of flowers.

“Miya always said she would change the world and we want to ensure her legacy lives on,” Scarbriel told local ABC affiliate in Miami, Florida, WPLG.

Marcano, who turned 19 in April and was a student at Valencia College, was last seen at the Arden Villas apartments complex in Orlando on Sept. 24. Her family reported her missing after she missed a flight home to South Florida that day.

Her body was found Oct. 2 near the Tymber Skan apartment complex in Orlando with her hands, feet and mouth taped over.

Orange County Sheriff John Mina said last week that Armando Caballero, 27, “is the person responsible for her death.” He was a maintenance worker at Arden Villas and was found dead Sept. 27, three days after Marcano disappeared, from an apparent suicide, authorities said.

Authorities previously said Caballero had expressed a romantic interest in Marcano but she rebuffed his advances. Caballero possessed a key fob to access apartments and his was used at Marcano’s unit just before her disappearance, authorities said.

Washington said the family is working to establish policies that will assure maintenance and other apartment complex employees do not have free access to people’s apartments without their permission. He said the family is also in talks with state politicians to potentially pass legislation on the issue.

“There’s really no laws to protect people from this type of invasion of privacy,” he said. “Right now we’re working on it on the state level, but hopefully that’s going to be something that can really go on the national level.”

Copyright © 2021, ABC Audio. All rights reserved.

In 2020, 62% of police deaths were caused by COVID: One officer’s story

In 2020, 62% of police deaths were caused by COVID: One officer’s story
In 2020, 62% of police deaths were caused by COVID: One officer’s story
Culpeper County, Virginia Sheriff’s Department Captain James Anthony “Tony” Sisk is pictured in an undated handout photo. Sisk died of COVID-19 on Oct. 1, 2021. – Culpeper County Sheriff’s Office

(NEW YORK) — James Anthony “Tony” Sisk was a lifelong law enforcement officer.

He had reached the rank of captain with the Culpeper County, Virginia, Sheriff’s Department.

Before that, he had worked in several different local departments starting in 1994, according to a department Facebook post

Sisk was a native of the area, graduating from Culpeper High School and a lifelong friend of current Culpeper County Sheriff Scott Jenkins, who Sisk went to work for after Jenkins was elected sheriff.

The father of two was respected by his co-workers, and in 2019 he was honored with a lifetime achievement award from the Culpeper Domestic Violence and Sexual Assault Task Force for his work in support of crime victims.

On Oct. 1, Sisk died of COVID-19 after being admitted to the hospital, the Facebook post said.

He was 50 years old.

“Tony’s death leaves a hole in our hearts and in our community that cannot be filled,” Sheriff Jenkins said. “His ready smile and warm embrace were well known to all. Knowing that Tony is resting with God helps a little to ease the tremendous pain of losing this outstanding human being. Rest In Peace, brother.”

COVID-19 has claimed the lives of almost 500 law enforcement officers, between 2020 and 2021, according to the Officer Down Memorial Page, a database that tracks line of duty officer deaths.

That represents 62% of all law enforcement line of duty deaths in 2020 alone, according to the statistics.

“It’s taken a definite toll,” Fayette County, Ohio, Sheriff Vernon P. Stanforth told ABC News. “Anytime there’s a line of duty death there, it impacts the entire agency and the entire law enforcement community.”

Standforth is president of the National Sheriffs’ Association.

Those fallen officers will be honored by Attorney General Merrick Garland during a candlelight vigil on Thursday night, according to the National Law Enforcement Museum.

Patrick Yoes, president of the National Fraternal Order of Police, one of the biggest police unions in the country called COVID-19 not only a public health crisis, but a public safety crisis.

“The National Fraternal Order of Police knew at the beginning of the pandemic that law enforcement officers on the front lines combating this pandemic would be increasingly vulnerable to contracting the virus,” Yoes said. “As we had feared, the virus has claimed the lives of many, and now includes a growing number of law enforcement officers.”

It is not known if Sisk ever got vaccinated.

The Fraternal Order of Police maintains that getting vaccinated for COVID-19 is a personal decision, as does Sheriff Standforth.

He said he believes the vaccine will become like wearing a bulletproof vest. At first, Standforth said, officers were apprehensive about wearing a vest, but as time went on, more and more started wearing them.

“We will eventually, just like the past, we will eventually get to the place, where we will say, OK, I can’t make the argument any longer I’ve got it, I’m going to take the vaccine to protect myself and my family,” the sheriff said. “I think that’s just cyclical and it’ll happen in due time.”

Copyright © 2021, ABC Audio. All rights reserved.

Why experts say monoclonal antibodies aren’t vaccine substitute

Why experts say monoclonal antibodies aren’t vaccine substitute
Why experts say monoclonal antibodies aren’t vaccine substitute
Inside Creative House/iStock

(NEW YORK) — Despite more than 187 million Americans being fully vaccinated against COVID-19 and data and attestations from researchers and public health officials that the vaccines are safe an effective, a small and in some cases vocal minority of Americans are reluctant to get the shot.

The reasons vary, but a number of those people are instead turning to treatments after they are diagnosed that have far less evidence to support their safety and effectiveness, including monoclonal antibodies — a trend that experts say is worrying.

Currently, over 1 million doses of monoclonal antibody infusions have been given in the United States. Use of monoclonal antibodies gained steam during the delta variant surge over the summer when Florida and other states opened clinics to administer the drugs in an attempt to keep sick people out of overwhelmed hospitals.

Monoclonal antibodies have been authorized for post-exposure prophylaxis, meaning they are used shortly after someone tests positive in order to prevent progression to severe disease. The antibodies range in effectiveness depending on type, but some have been shown in to reduce COVID-related hospitalization or death by up to 85%.

COVID-19 vaccines have been tested in large clinical trials with hundreds of thousands of people. The CDC says over 215 million people have safely received at least one dose of a COVID-19 vaccine, including 187 million who have been fully vaccinated, either with the one-dose Johnson & Johnson shot, or two dose mRNA vaccines.

All three COVID-19 vaccines have gone through the most intensive safety monitoring in U.S. history by government agencies, fully independent safety monitoring boards, vaccine manufacturers and academic researchers. The Pfizer COVID vaccine is currently FDA authorized for people 12 and older. The Moderna and Johnson & Johnson vaccines are authorized for those 18 and up.

Common side effects of the COVID-19 vaccine include pain or swelling at the injection site. Fever, muscle aches, chills, fatigue or headaches can also occur but should go away within a few days. More serious health problems, such as unusual heart rhythm or blood clots, are exceedingly rare — and in fact, are more likely to happen to an unvaccinated person who becomes sick with COVID-19 than with the vaccine itself.

‘More concerned with treatment rather than prevention’

Many vaccine holdouts in the U.S. have cited the vaccines’ emergency use authorization status — a special FDA pathway helps accelerate the often-slow regulatory process during a national emergency. Pfizer’s vaccine is now fully FDA approved for people 16 and older, while Moderna and Johnson & Johnson are still under emergency authorization, awaiting approval.

However, some experts interviewed by ABC news say some patients who won’t get vaccinated also ask for monoclonal antibody treatment after the are diagnosed with COVID, which has the same emergency use authorization. Doctors say they are perplexed about why some people pursue monoclonal antibody treatment which is supposed to reduce the risk of hospitalization in high-risk vulnerable people instead of prevention.

“People are more concerned with treatment rather than prevention,” said Rupali Limaye, Ph.D., the director of behavioral and implementation science for the International Vaccine Access Center at Johns Hopkins School of Public Health.

“When they are in the hospital and needing COVID treatment, their options are limited — but they know they need treatment to fight COVID. Decision-making is very different related to preventative behaviors,” said Limaye.

What to know about monoclonal antibodies

The FDA has granted emergency authorization status to four antibody treatments for COVID-19. These antibody treatments are most helpful in mild to moderate disease. Not all antibody treatments are equally effective, and some have lost their potency in the face of new COVID-19 variants.

According to the FDA, monoclonal antibodies are laboratory-made proteins designed to mimic the immune system’s ability to fight disease particles known as antigens. For example, sotrovimab is a monoclonal antibody that prevents COVID-19 infection by blocking the virus’ spike protein.

The data supporting these antibodies is much more limited than the extensive data supporting currently approved and authorized vaccines.

“Monoclonal antibodies are an important treatment option for high-risk patients. However, the idea that they can be used as a prevention tool is severely misguided,” said Dr. Andrew Pavia, Infectious Diseases Society of America fellow, NIH COVID treatment guidelines panel member and chief of pediatric infectious diseases at the University of Utah School of Medicine.

“They are no substitute for cheap and effective prevention tools like masks and vaccines,” said Pavia.

Other COVID treatments under EUA include tocilizumab, a monoclonal antibody that is not directed toward the virus but instead reduces inflammation in already hospitalized patients. Remdesivir, an anti-viral, is FDA approved for hospitalized patients over 12 but under EUA for kids less than 12.

All of these treatments require an infusion and a trip to a medical center. Now, pharmaceutical companies are also working on easy-to-prescribe pills that can ease symptoms for people who are already sick, but doctors stress these are also not a replacement for a vaccine that can help prevent disease in the first place.

Ways to boost vaccination

Doctors interviewed by ABC News say their patients want an easy solution that will protect them from COVID-19. For most, that’s a vaccine. For others, misinformation surrounding vaccines can stand in the way, prompting them to seek alternatives.

“Hesitancy falls on a continuum. That means that those that are hesitant may refuse some vaccines, may accept vaccines but be unsure about the decision or may have concerns. There are validated scales that measure attitudes related to safety, efficacy, past vaccine behavior and vaccine intentions.” said Limaye.

The CDC suggests providers ask vaccine-hesitant patients a scaled question, for example, “On a scale of 1 to 10, how likely are you to get the COVID vaccine? (1 = never and 10 = vaccine appointment is already set).” The goal is to help patients become more aware and move toward higher numbers on the scale.

For example, if a patient says that they are a three on the scale, providers can ask why and why not a lower number? This helps patients to reiterate the benefit of vaccines instead of explaining why they have not gotten it. Providers can then further follow up by asking, “What would help to go to a four or a five?”

While there are many successful ways to talk to people about the COVID vaccine — all methods center around a common theme of empathy, curiosity and open communication to help end the pandemic.

ABC News’ Sony Salzman contributed to this report.

Jess Dawson, M.D., a Master of Public Health candidate at Johns Hopkins Bloomberg School of Public Health, is a contributor to the ABC News Medical Unit.

Copyright © 2021, ABC Audio. All rights reserved.

Don’t rely on safety systems in cars during bad weather, American Automobile Association warns

Don’t rely on safety systems in cars during bad weather, American Automobile Association warns
Don’t rely on safety systems in cars during bad weather, American Automobile Association warns
c1a1p1c1o1m1/iStock

(NEW YORK) — The American Automobile Association (AAA) is warning drivers nationwide not to over-rely on advanced safety systems in cars, like automatic braking and lane assist systems, during inclement weather.

New research from the organization found that heavy rain affects safety features from functioning properly, which can result in performance issues.

During AAA experiments, vehicles equipped with automatic emergency braking, that traveled at 35 mph, collided with a stopped vehicle one third of the time.

“Often these systems are tested in somewhat perfect conditions,” Greg Brannon, AAA’s director of automotive engineering and industry relations, told ABC News. “But the reality is drivers don’t drive in perfect conditions.”

In the experiment, AAA simulated rain and other environmental conditions, such as bugs and dirt, to measure impact on the performance of various advanced driver assistance systems (ADAS).

To simulate rainfall, AAA engineers designed a system using a reservoir to hold water atop the cargo area of the test vehicle. The system was connected to a nozzle positioned above the windshield, so the spray pattern covered the entire windshield.

“We created a device that allowed the windshield to experience basically what it would in a rainstorm,” Brannon said.

AAA also found that cars with lane keeping assistance departed their lanes 69% of the time.

“It’s pretty, pretty substantial and surprising findings for something that is on a lot of cars today,” Brannon said.

The tests were conducted with five different vehicles, including the 2020 Buick Enclave Avenir with automatic emergency braking and lane keep assist, a 2020 Hyundai Santa Fe with forward collision avoidance assist and lane keeping assist, a 2020 Toyota RAV4 with pre-collision system and lane tracing assist, and a 2020 Volkswagen Tiguan3 with front assist and lane assist.

According to the National Highway Traffic Safety Administration (NHTSA), “Driver assistance technologies hold the potential to reduce traffic crashes and save thousands of lives each year.”

The agency said more than 36,000 people died in motor vehicle crashes in 2019 — many of which were tied to human error.

Brannon said consumers should use advanced safety systems, but not in the place of engaged driving. “The most dangerous thing that a consumer can do is to over-rely on the systems.”

“AAA’s advice to consumers that have advanced safety systems in their car really is the same regardless of what that system is, and that’s to drive the car like the system is not there,” Brannon said. “Select a car that has the most advanced safety systems available, because they all hold a lot of potential to reduce injury and save lives, and that’s a good thing.”

Brannon said drivers should never use cruise control during inclement weather, and he advised motorists to slow down.

“Really understand the environment that you’re operating in and then make sure that you are fully engaged in that task of driving,” Brannon said.

Copyright © 2021, ABC Audio. All rights reserved.

Henrietta Lacks family seeks justice: Grandchildren sue biotech company

Henrietta Lacks family seeks justice: Grandchildren sue biotech company
Henrietta Lacks family seeks justice: Grandchildren sue biotech company
JHVEPhoto/iStock

(NEW YORK) — The family of Henrietta Lacks, an African American woman whose cells were collected from her body and used for medical research without her consent in 1951, is seeking justice for their relative.

On Oct. 4, the 70th anniversary of her death, Henrietta Lacks’ family filed a federal lawsuit against Thermo Fisher Scientific claiming unjust enrichment and nonconsensual use of her cells and tissue samples.

The Lacks family has retained Benjamin Crump as their lead attorney. Crump, who previously represented the families of George Floyd and Breonna Taylor, says he believes this case can bring justice to the family.

“This whole notion of her cells are being sold even to this day as chattel property when everyone benefits from it but her own family. Her own flesh and blood. It reminisces of days of slavery when they sold black people as chattel property and we never got to benefits from our labor, our contributions,” Crump said.

In 1951, at the age of 31, Henrietta was diagnosed with cervical cancer and began treatment at one of the only facilities willing to treat African Americans, Johns Hopkins Hospital in Baltimore. During her treatment, a gynecologist preformed a biopsy on her and sent her tissue to a lab for research, without her consent or that of her family’s.

In subsequent experiments with her tissue sample, scientists discovered that Henrietta’s cells reproduced and thrived outside of her body — a discovery that helped shape medical innovations.

Those cells were named, “HeLa” after Henrietta Lacks. HeLa cells have led to several medical breakthroughs including the polio vaccine, coronavirus vaccines, cancer treatments, AIDS treatments, zero gravity in space, and more.

What Henrietta Lacks experienced is now illegal and researchers are required to get consent before using a patient’s tissue sample for research according to federal law.

The family members say they have not received any profit from the research and use of Lacks’ cells. They say they believe the time is now to be compensated and they are aware they will have to fight as many as 100 defendants, the first being Thermo Fisher.

Thermo Fisher Scientific Inc., based in Massachusetts, sells HeLa cells on its website.

“Thermo Fisher Scientific’s business is to commercialize Henrietta Lacks’ cells—her-living bodily tissue—without the consent of or providing compensation to Ms. Lacks” the lawsuit states. “All the while, Thermo Fisher Scientific understands—indeed, acknowledges on its own website—that this genetic material [is] stolen from Ms. Lacks.”

The lawsuit is also asking the court to order Thermo Fisher Scientific to “disgorge the full amount of its net profits obtained by commercializing the HeLa cell line to the Estate of Henrietta Lacks.”

Christopher Seeger, another attorney for the Lacks family, said that other companies also will be targeted for commercializing Lacks’ cells.

Thermo Fisher Scientific, he said, “shouldn’t feel too alone because they’re going to have a lot of company soon.”

Lack’s story emerged about a decade ago with the release of the book, “The Immortal Life of Henrietta Lacks.”

Her story gained more national attention with the release of “The Life of Henrietta Lacks” movie. Oprah Winfrey starred as Henrietta’s daughter, Deborah Lacks, and Renee Elise Goldsberry portrayed Henrietta.

Ron Lacks says his mother was the first person in the family to discover that cells obtained from her deceased mother-in-law, Henrietta Lacks, were still viable in 1973.

Ron Lacks is the estate’s executor and the oldest grandson of Henrietta. For years he has been inspired by his mother’s resilience to keep Henrietta’s name alive and he is using this inspiration to fight for his family’s ownership of his grandmother’s legacy.

“Every time, I walk into my mother’s room, she gives me strength because I know I’m doing it for her. She started this in 1973. She started this, so when I walk into her room and feed her, change her, I know I’m doing this for her.” Ron Lack told ABC News. “When you fighting for your family, you come off with all guns blazing, you don’t stop until you succeed or they knock me down,” he added.

Johns Hopkins University states on its website that it has “never sold or profited from the discovery or distribution of HeLa cells” and that the university does not own the rights to the HeLa cells.

The university also claims it has helped the Lacks family broker an agreement that requires scientists to receive permission to use Henrietta Lacks’ genetic blueprint.

Copyright © 2021, ABC Audio. All rights reserved.

Woman who struggled for months with weight gain diagnosed with 17-pound cancerous tumor

Woman who struggled for months with weight gain diagnosed with 17-pound cancerous tumor
Woman who struggled for months with weight gain diagnosed with 17-pound cancerous tumor
Courtesy of Amanda Shoultz

(DALLAS) — Amanda Shoultz said she spent most of the past year trying to lose weight after noticing that her stomach kept getting bigger.

“I started working out more. I was dieting more and, oddly enough, I was losing weight but I was gaining inches in my stomach,” Shoultz, 29, told Good Morning America. “For the longest time, I thought, ‘Oh, I just must gain weight in my stomach.'”

When Shoultz, of Dallas, Texas, went to her annual checkup with her primary care physician in February, she said she was shocked at the number she saw on the scale.

“I remember telling her, ‘The next time you see me I’m going to be 10 pounds lighter,'” said Shoultz. “I just assumed it was my fault. That I had done something wrong.”

Shoultz’s blood work from her doctor’s appointment came back normal, so she said she kept changing her diet to see if she had an allergy that was causing her stomach to bloat.

“I gave up all dairy products because I thought it was a lactose allergy, and nothing changed. Then I gave up gluten. I love bread but I was willing to do anything,” she said. “That didn’t work so then I gave up meat. None of that helped.”

Shoultz said she did not feel any pain beyond the discomfort of her stomach getting so much bigger than usual.

By August, nearly eight months after first noticing the growth, Shoultz was referred to a gastroenterologist by a colleague at Baylor Scott & White Heart and Vascular Hospital, where she works in public relations.

“By the time I saw my GI [gastroenterologist] doctor, my stomach was hard as a rock,” she said. “My mom said you could have punched me in my stomach and broken your hand it was so hard.”

After several tests that did not find anything definitively wrong, Shoultz underwent a CT scan in late September.

“About four hours later, I got a call from my doctor who told me I had a 33-centimeter tumor in my abdomen,” she recalled. “And within two days of that, I was already meeting with the surgeon.”

Doctors discovered that Shoultz’s tumor was cancerous. She was diagnosed with liposarcoma, a rare form of tumor that, in most cases, does not present any symptoms until the tumor grows large and invades other organs or tissues, according to the National Institutes of Health (NIH).

In Shoultz’s case, the tumor had formed around her right kidney and adrenal gland, but she experienced no symptoms to indicate that cancer was growing inside her.

“I’m 29 and otherwise perfectly healthy,” she said. “I had no other symptoms other than my stomach.”

On Sept. 27, Shoultz underwent a two-hour surgery to remove the tumor, which doctors discovered upon removal weighed 17 pounds.

Doctors also had to remove Shoultz’s right kidney and part of her adrenal gland. Because the cancer had not spread to other parts of her body, she did not have to undergo further treatment, like chemotherapy or radiation.

“Once I left the hospital, my stomach was back to normal,” said Shoultz. “Now I’m just eating all the food that I missed when I gave it up for a year in order to put some weight back on.”

Shoultz said she is sharing her story publicly because she wants other people, particularly women, to know the importance of knowing and listening to their own bodies.

“I knew that something was wrong because I’ve always had a hard time gaining weight,” said Shoultz. “When I was getting so large in my abdomen and I couldn’t control it, that’s when I knew something was off.”

“We preach it at the hospital, don’t die of doubt,” she said. “No one else is going to need to fight for you, so fight for yourself and find a care team that is going to care for you through the journey.”

It’s a message echoed by Dr. Robert Mennel, an oncologist with Texas Oncology at Baylor University Medical Center in Dallas, who is treating Shoultz.

“There is a whole group of these sarcomas that tend to occur in younger people and a lot of times they have symptoms that are sort of very nondescript symptoms,” he said. “If somebody comes in and they have some abdominal discomfort and it’s somebody who’s in their 20s or so, most physicians think that’s probably not much and it will pass.”

“We can’t do scans on everybody, but if you really feel that something is wrong, just be persistent to get this evaluated,” added Mennel. “And make sure you’re going to somebody who has experience and really knows what they’re doing.”

“The takeaway would be that if you feel that something is not correct, see a physician or health care provider to let them evaluate it,” he said. “And if you really feel that they’re not evaluating it, or if you really feel that something’s wrong, pursue your desire to get it looked at and worked up.”

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US pushes diplomacy, prepares sanctions as Ethiopia launches new offensive in brutal war, risking famine

US pushes diplomacy, prepares sanctions as Ethiopia launches new offensive in brutal war, risking famine
US pushes diplomacy, prepares sanctions as Ethiopia launches new offensive in brutal war, risking famine
beyhanyazar/iStock

(WASHINGTON) — Nearly a month after President Joe Biden created a new U.S. sanctions authority and threatened to impose economic penalties on Ethiopian leaders unless they halted a conflict in the country’s northern province, that war is now escalating.

The worsening fighting puts millions of lives at risk amid reports of famine-like conditions already faced by up to 900,000 people and severe food insecurity impacting 6 to 7 million, according to U.S. officials.

The U.S. announced Tuesday it is providing $26 million more humanitarian aid, but that will do little to stop the suffering as of now. Aid convoys into the Tigray region have been blocked and attacked throughout the conflict, with a particularly brutal blockade by the Ethiopian government for nearly 110 days now keeping resources like food, fuel and medicine out.

“Looking forward, it’s pretty dark and pretty bleak without a significant change either politically or militarily — I hate to say that, but the status quo really cannot continue. The famine is only going to start taking more lives at an accelerated pace,” said David Del Conte, the former deputy director for Ethiopia at the United Nations’ humanitarian agency.

Spurred by warnings like that, the U.S. seemed to kick diplomacy into a higher gear this week, too. The U.S. hosted a summit of high-level donor countries to urge humanitarian access and a halt to fighting — openly weighing the possibility of a humanitarian airlift. Secretary of State Antony Blinken also met with the African Union’s envoy trying to negotiate a ceasefire.

But once again, it is all seems to be falling on deaf ears on the ground. In the last week, the Ethiopian government launched a new major military offensive against Tigrayan forces, the country’s former longtime ruling party that has been at war with the federal government since last November.

Every side in this nearly one-year-old conflict has been accused of atrocities, in some instances documented in great detail by monitors like Amnesty International and media outlets. Blinken has said the U.S. has seen reports of “ethnic cleansing” — but increasingly, reports from the region are hard to come by because the Ethiopian government has cut cell phone and internet communications.

State Department spokesperson Ned Price said Tuesday the U.S. was aware of the reported offensive, adding, “Escalating fighting undermines critical efforts to keep civilians safe and the ability of international actors to deliver humanitarian relief to all those in need, and we know there are too many in need.”

The Biden administration is “considering the full range of tools,” including using those economic sanctions that Biden authorized last month, Price added. One source familiar with the administration’s plans said those sanctions are being prepared, although Price declined to preview any announcement Tuesday.

But it’s unclear what, if any, effect that will have on Ethiopian officials, up to and including Prime Minister Abiy Ahmed. His government declared a ceasefire in June as its military and aligned forces retreated from Tigray and Tigrayan troops retook territory. But fighting has continued, including Tigrayan offensives into neighboring regions like Amhara and Afar — each side defying threats of sanctions from the U.S., European Union and others.

“From Abiy’s perspective, this fight is existential, at least politically for him, so the idea that these sanctions are going to make him turn on a dime and reevaluate the nature of the campaign is unlikely,” said Hardin Lang, vice president for programs and policy at Refugees International, an advocacy group. But, he added, it is an important “tool” that could “erode support of those around Abiy.”

Abiy’s blockade has created shortages of food, fuel, medicines and medical supplies, and cash in Tigray, while continued fighting threatens to heighten humanitarian crises in neighboring regions. The United Nations, aid groups and other countries, including the U.S., have increasingly sounded the alarm about the risk of a massive famine in Tigray and beyond, especially now in Amhara and Afar.

In total, more than 2 million people have fled their homes, and some 48,000 have fled across the border into neighboring Sudan as refugees, according to U.S. officials.

In response to those warnings, however, the Ethiopian government expelled U.N. officials from the country two weeks ago — sparking more international condemnation. Ethiopia’s ambassador to the U.N. accused those officials last Wednesday of falsifying data — prompting a striking rebuttal from U.N. Secretary-General Antonio Guterres.

Already, there are reports of people starving to death. USAID Administrator Samantha Power said today that people are going multiple days without food, left to eat leaves.

“Innocent Ethiopian lives depend upon the government of Ethiopia immediately reestablishing communications, banking and other vital services within Tigray, and fully restoring transport corridors and air linkages to Tigray,” said Power, who convened Tuesday’s high-level meeting of G7 countries and other major donor countries.

The countries discussed the “possibility of augmenting road operations — which are failing to meet urgent humanitarian needs due to government obstruction — by expanding air operations to deliver relief supplies directly to the region,” she added in her statement.

That kind of airlift would still require the Ethiopian government’s permission, however, and would be far less effective at bringing in supplies than convoys of trucks, according to Del Conte. One cargo aircraft would cost more than up to 100 trucks in a convoy, he said, while feeding only about as much aid as what one double-trailer truck could carry.

In addition to Power’s summit, Blinken held his own high-level meetings Tuesday on Ethiopia. He met one-on-one first with the African Union’s Olusegun Obasanjo, the former Nigerian president now serving as special envoy for the Horn of Africa — before they joined Sudanese Prime Minister Abdalla Hamdok, who heads the regional bloc the Intergovernmental Authority on Development, along with the EU and UK’s top diplomats and senior diplomats from Germany and France.

Together, they discussed the conflict and agreed to urge “the parties to the conflict to immediately end abuses, to enter into negotiations toward a ceasefire, and to lay the foundation for a broader and inclusive dialogue to restore peace in Ethiopia and preserve the unity of the Ethiopian state,” Price told reporters during a briefing.

But with this new offensive, it seems clear Abiy has no interest in a dialogue — instead hoping a communications blackout means the world will not pay attention.

“The government in Addis has shown remarkable commitment to a military solution to the conflict,” said Del Conte, now the leader of Refugees International’s Stop Tigray Famine campaign. “What we see out of northern Ethiopia is going to be dramatic and significant. … I’m deeply concerned at the unwillingness to change directions in any way.”

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Off-duty female NYPD officer fatally shoots woman after finding her with partner, police say

Off-duty female NYPD officer fatally shoots woman after finding her with partner, police say
Off-duty female NYPD officer fatally shoots woman after finding her with partner, police say
Ben185/iStock

(NEW YORK) — A New York City police officer is in custody after she allegedly shot two women, killing one, at a home in Brooklyn.

The officer, who was off-duty at the time, is believed to have shot both women — one of whom she was dating — when they returned to the home where the officer’s girlfriend lived.

Police said the off-duty officer shot a 24-year-old woman in her chest, “possibly more than one time,” at the Bensonhurt home. The victim, identified as Jamie Liang, was taken to Maimonides Medical Center and was pronounced dead, police said.

The other woman, a 23-year-old, who was in the romantic relationship with the officer, was shot in the torso and is expected to survive, police said.

The suspect, 31, is a police officer in the 72nd District, which encompasses the Park Slope and Sunset Park areas of Brooklyn.

The officer had worked for the NYPD for 5 1/2 years. Police said she was at a local hospital for evaluation.

“We believe it is domestic in nature. We believe all three parties knew each other,” Assistant Chief Michael Kemper, commanding officer of Patrol Borough Brooklyn South, said at a press conference Wednesday evening.

“We believe they had an intimate relationship,” he said of the officer and the 23-year-old woman.

The officer remained at the scene and told police she had shot the two women, according to police.

Police said they were still investigating, but recovered a gun on the scene and “there’s a very good chance it is her service weapon,” Kemper said.

“The whole incident is horrible, but these cops performed great, just heroically, and this is what NYPD cops come upon every single day,” Kemper said. “Is this an incident they would want to come upon? No. But unfortunately throughout their careers they come upon this.”

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