Health

(WASHINGTON) — Inclined sleepers for babies and crib bumper pads will be banned from being sold under legislation passed Wednesday by Congress.

The bill, known as the Safe Sleep for Babies Act, will now go to the White House for President Joe Biden to sign.

Among the advocates calling on Biden to sign the legislation quickly into law is Erika Richter, whose 2-week-old daughter, Emma, died while using a Fisher-Price Rock ‘n Play sleeper, a type of incline sleeper that would be banned under the new legislation.

“For this bill to be passed, it’s a huge win, and for it to have bipartisan support just highlights that this change was long overdue and undeniably necessary,” Richter, of Portland, Oregon, told Good Morning America. “There are 4.7 million of these products sold.”

Richter has been a vocal advocate for change since the death of Emma, her only child, in August 2018.

In 2020, Richter filed a lawsuit against Fisher-Price for wrongful death and gross negligence. The case is ongoing in Los Angeles County Superior Court and Richter declined to provide details on her daughter’s cause of death due to the litigation.

In its answer to the lawsuit, Fisher-Price has denied all of the allegations and specifically denied “that because of an act or omission by them, their agents, or independent contractors, Plaintiffs were injured or damaged in any sum, or at all.”

It was only after Emma’s death that Richter said she learned about reports of other infant deaths associated with Rock ‘n Play sleepers, which were recalled in 2019 by the Consumer Product and Safety Commission (SCPC) after being linked to over 30 deaths.

“I thought to myself, ‘If I had just known sooner,'” said Richter. “I wish that somebody had done what I’m doing and what some of the other mothers are doing more publicly around the time that I had Emma.”

Last June, Richter shared her story publicly for the first time at a congressional hearing that followed up on a report from the House Committee on Oversight and Reform. The report found Fisher-Price ignored repeated warnings that its Rock ‘n Play sleeper was dangerous before the device was recalled.

The report found more than 50 infant deaths were linked to the sleeper, which puts infants at a 30-degree incline.

The cause of death for some of the babies was asphyxia, or the inability to breathe, due to the child’s position, the report said.

“We trusted a name brand, and we were wrong,” Richter said in her testimony, holding up baby clothes as a reminder of what she has left to remember her daughter.

When Richter first shared her story publicly last June, a spokesperson for Mattel, the parent company of Fisher-Price, told ABC News in a statement there “is nothing more important” to the company than the safety of its products and that its “hearts go out to every family who has suffered a loss.”

“The Rock ‘n Play sleeper was designed and developed following extensive research, medical advice, safety analysis and more than a year of testing and review,” a spokesperson said, adding that independent medical and other expert analyses verified that the sleeper was safe when used in accordance with its instructions and warning. “It met or exceeded all applicable regulatory standards. As recently as 2017, the U.S. Consumer Product Safety Commission (CPSC) proposed to adopt the ASTM voluntary standard for a 30-degree angled inclined sleeper as federal law.”

A Mattel spokesperson confirmed to ABC News Thursday the Rock ’n Play Sleeper is no longer on the market, noting it, “was sold from its introduction in 2009 up until its voluntary recall in April 2019.”

Guidelines from both the CPSC and the American Academy of Pediatrics (AAP) say caregivers should always place infants to sleep on their backs on a firm, flat surface and should never add “blankets, pillows, padded crib bumpers, or other items to an infant’s sleeping environment.”

In addition, caregivers should not use infant sleep products with inclined seat backs of more than 10 degrees, and should not use infant car seats, bouncers and other inclined products for sleep, according to the guidelines.

Around 3,400 babies in the U.S. die each year while sleeping, in sudden and unexpected deaths, according to the AAP, which issued a statement Wednesday applauding the passage of the Safe Sleep for Babies Act.

“The message from pediatricians has long been clear: the safest sleep environment for babies is a firm, flat, bare surface,” AAP’s president, Dr. Moira Szilagyi, said in a statement. “Despite what the science shows, crib bumpers and inclined sleepers have remained on the market and store shelves, misleading parents into thinking they are safe and leading to dozens of preventable infant deaths.”

Experts say that padded crib bumpers, which are also banned under the new legislation, pose a particular potential danger because babies may turn their faces into the bumper’s padding, raising the risk of suffocation, may become entrapped underneath or around the bumper, or may become entangled in the bumper’s ties, increasing the risk of strangulation.

Even when federal crib standards changed in 2011, mandating a smaller distance between crib slats so babies would not get their heads stuck between them, crib bumpers — which arguably had lessened that risk — became unnecessary, but they remained on the market, despite the safety risk, according to Dr. Ben Hoffman, a professor of pediatrics at Oregon Health & Science University and chairman of the AAP’s Council on Injury, Violence, and Poison Prevention.

“There is an assumption that [products] are safe until they are proven dangerous, as opposed to what I think the public believes, which is if something is sold, it is safe,” Hoffman told ABC News last year.

Richter said she too has learned from her advocacy work since Emma’s death that parents need to be cautious consumers when it comes to the products they use with their kids.

“I have learned that we have a long way to go when it comes to consumer protections, and that legacy brands do not equal trust,” she said. “People die because they make assumptions that the brands themselves are doing their due diligence, and you cannot put that type of control in the hands of profit maker or profit owner.”

Richter said she plans to continue to push for more consumer controls, including calling on Congress to repeal a provision, 6B, in the Consumer Product Safety Act that she claims allows companies to “self-regulate” when it comes to product safety.

Richter said she also plans to keep speaking out to raise awareness and make sure banned infant sleep products don’t end up in the hands of other mothers.

“I’m still a mom. I’m still Emma’s mom. I still have that responsibility, and I still think like a mom and I still want to protect other moms and other children,” she said. “That is so important to me.”

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(NEW YORK) — As abortion rights increasingly come under threat across the country — with states like Oklahoma enacting “copycat” bills of sweeping Texas legislation that criminalizes abortion and with the Supreme Court poised to overturn abortion protections — advocates anticipate that women seeking abortion options will look outside the traditional health care system more and more.

For many women, that may mean pursuing a so-called medication abortion.

Medication abortions rely on pills, rather than surgery, to terminate the pregnancy. Usually two drugs — mifepristone and misoprostol — are used in combination to induce the abortion. In 2020, the number of medication abortions exceeded the number of surgical abortions for the first time, according to the Guttmacher Institute, a reproductive health policy research organization.

In “self-managed” cases, women do not undergo their abortions in a formal health care setting, according to the Guttmacher Institute.

That’s in contrast with “supervised” cases where women undergo their abortions under the watchful eye of supervising clinicians. Currently, 19 states require clinicians to be physically present when the medication is administered, according to the Guttmacher Institute.

But since the Texas law and its copycats place health care providers who facilitate pregnancies at legal risk — including telehealth clinicians who support the process virtually — supervising health providers could be held legally liable, Elizabeth Sepper, a professor of law at the University of Texas at Austin, told ABC News.

For example, the recently passed Oklahoma legislation could hold any individual — doctors, nurses, pharmacists — that “aids or abets the performance or inducement of an abortion” legally liable. This raises the concern that — to avoid liability — those individuals might turn away women seeking abortions, Sepper told ABC News.

As a result, pursuing a medication abortion increasingly means self-managing the process without medical supervision, Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation, told ABC News.

Sometimes, that’s meant crossing international borders into Mexico or Canada to obtain pills.

“I think there’s no question that people seeking abortions will look into any option,” Salganicoff told ABC News, “just because you ban an abortion doesn’t mean women won’t continue to seek them.”

More often, that’s meant turning to the postal service.

In July 2020, following a suit by the American Civil Liberties Union, the Food and Drug Administration temporarily suspended restrictions allowing mifepristone to be delivered by mail. Last December, the FDA permanently lifted those restrictions.

There are now numerous companies and international pharmacies devoted to shipping pills, according to Plan C, an information portal for self-managed abortion services. Some companies even ship to a handful of states — like Arizona and Texas — where mailing abortion pills is illegal.

The number of pills currently being sent through the mail is difficult to track, Abigail Aiken, an associate professor in health policy at the University of Texas at Austin, told ABC News.

But requests for the medicines by mail have skyrocketed in Texas since the legislation: one study found that, after the passage of the law, requests sent to Aid Access — the country’s largest telehealth abortion provider — leapt 10-fold in the week after it was enacted. Daily requests remained twice as high as the pre-legislation baseline over the next three months, after which point the researchers stopped tracking.

“I think we can see that making abortion illegal doesn’t limit the need for abortion,” Abigail Aiken, who is also the lead investigator on the study, told ABC News, “it just shifts where individuals can find care.”

Data on information seeking for self-managed abortions acquired by ABC News suggests these patterns in Texas may foreshadow broader trends across the country.

In the week after the Supreme Court’s draft decision leaked to the press, page views and overall users on Plan C’s website increased seven-fold. The number coming from states with Texas copycat laws leapt further still: page views from users in Idaho increased 23-times, and page views from those in Oklahoma increased 18-times, according to Elisa Wells, co-director of Plan C.

The good news about self-managed medication abortions, Aiken told ABC News, is that they appear safe and effective for most women who use them early in pregnancy. Recent U.S.-based studies have reported that up to 96% of women undergoing self-managed medication abortions before 10 weeks of gestation successfully terminated their pregnancy.

But doctors fear that the success rates will likely be lower in women who turn to the medications in lieu of other options who are further along in their pregnancy. The later the pregnancy, the higher risk that something will go wrong for women attempting self-managed medication abortions – including blood infections that can be life-threatening without urgent medical care, experts said.

“I have some concern that … regardless of whether their self-assessment [for gestational age] says they’re eligible, they’ll use the pills — because they’re desperate,” Daniel Grossman, professor of obstetrics and gynecology at the University of California San Francisco, told ABC News.

Then there’s the legal risk. In Texas, women like Lizelle Herrera have already been arrested under murder charges after their abortions came to light. Seeking medical care could similarly leave them vulnerable to criminal prosecution, Sepper told ABC News, which would further discourage them from seeking care.

If women with abortions who need care avoid it out of concern for legal consequences, it could endanger their health, Grossman told ABC News.

Despite all the potential upsides of medication abortions, the risk of undue death is what advocates fear most. Especially, since abortion seekers are disproportionately from groups that already face the highest rates of maternal death, including communities of color.

“We know that when abortion is illegal, it doesn’t make it less common, it just makes it less safe,” Danika Severino Wynn, vice president of abortion access at Planned Parenthood, told ABC News.

“When we push people further into the shadows, it means we are undoubtedly making their care more dangerous,” Wynn said.

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(NEW YORK) — People of color will face the brunt of the impact if Roe v. Wade is overturned by the Supreme Court, abortion rights advocates warn.

The landmark decision that protected a person’s right to have an abortion is in danger of being overturned by the high court’s conservative majority, according to a draft court opinion leaked this week to Politico.

Activists who work in Black and brown communities fear the socioeconomic effects of this potential decision from the highest court in the country. Abortion rights, they say, are an economic and health justice issue.

Abortion rights advocates say there are several factors that may go into a person’s decision to seek an abortion, including health care access and quality, financial support and willingness to be pregnant.

“This is not something where it’s either: make a choice to choose to be a parent or not to choose to be a parent,” said Oriaku Njoku, co-founder and executive director of ARC-Southeast, an abortion fund in Georgia that serves six states across the Southeast region. “There’s so many things like access to food, access to a living wage, access to insurance, your race, your gender, your ability to make money for your family.”

She says that not just the right to have an abortion, but also the right to access an abortion has long been threatened and that many people are struggling with the multifaceted injustices in poverty, health care and stability.

The demographics of abortion patients

In the most recent data from the CDC in 2019, Black women had the highest rate of abortions with 23.8 abortions per 1,000 women.

Hispanic women had 11.7 abortions per 1,000 women, according to the CDC. White women had the lowest rate: 6.6 abortions per 1,000 women. The majority of these women — 56.9% — were in their 20s, according to the data.

The country’s most marginalized will be affected by looming abortion bans: people already impacted by poverty, lack of healthcare access and racism in the healthcare system, advocates say.

“This fight for abortion access that we’re in right now is a fight against white supremacy in this country,” said Monica Raye Simpson, the executive director of the Southern-based reproductive justice group SisterSong.

“When we live in a world in a country where access to health care is already extremely limited to people of color … that is a problem,” said Simpson.

She continued, “To think about what it would mean to take care of themselves, accepting themselves as a family, like all of these are parts of a decision that one has to think about when thinking about creating a family.”

Health care challenges for people of color

Research has shown that racial and ethnic minorities often receive lower-quality health care than white people.

Even when factors like income, age, condition, and insurance are comparable, research has shown that Black and brown people are still failed by the health care system.

These poor health systems contribute to worse health conditions: Black people are at higher risk for heart diseases, stroke, cancer, asthma, diabetes, according to the Department for Health and Human Services.

Experts say America’s poor systems of health make abortions a vital part of health care for people of color.

Black and Hispanic women are more likely than white women to experience health complications during pregnancy and childbirth, according to Blue Cross Blue Shield Association.

A recent report from the Centers for Disease Control and Prevention also found that Black women died of maternal causes at nearly three times the rate of white women in 2020.

The rate for Black women was 55.3 deaths per 100,000 in 2020 and the rate for white women was 19.1 deaths per 100,000, according to the CDC. For Black women, the rate increased nearly 26% from the year prior.

Being pregnant presents some kind of risk. And unintended pregnancies increase the risk for poor maternal and infant outcomes, the CDC reports.

“The real issue is the historic and ongoing disparities and access to quality health care, and sexual and reproductive health information in Black and brown communities,” Njoku told ABC News. “This is denying the next generation a better future. Improving access to health care, education, family planning; I feel like those are better ways to reduce unintended pregnancies than trying to restrict abortion.”

For others, terminating unintended pregnancies can be a financial decision.

The financial implications of pregnancy

Activists say an abortion ban will only push pregnant people into poverty or into debt. Pregnancy and childbirth alone can cost thousands of dollars.

Black and Hispanic people are 1.8 and 1.5 times as likely to be in poverty than white people, according to 2019 census data.

The Economic Policy Institute also found that Latinas earn 57 cents and Black women earn 65 cents for every dollar earned by white, non-Hispanic men.

“When there are barriers placed on someone’s ability to access abortion care, it pushes them farther into pregnancy, and has pretty devastating financial implications for folks who have to pay out of pocket if their insurance doesn’t cover abortion care,” said Morgan Hopkins, the executive director of campaigns and strategies for abortion rights group All* Above All.

“It only gets more expensive the further into pregnancy you go,” Hopkins said.

However, many reproductive rights activists say that even while Roe is the law of the land, abortion is still hard to access for many across the country.

“Codifying Roe is not going to make abortion more accessible,” said Njoku. “It’s not going to change the fact that we live in places where there are abortion deserts … it’s not going to change the fact that people are crossing state lines to get abortions.”

According to reproductive care researchers at the Guttmacher Institute, abortion access has long been limited for those in states with stronger abortion restrictions, that already push people to travel out of state.

In states with anti-abortion rights legislation, the organization found a high correlation between the “proportion of women whose nearest provider was in another state and the proportion who obtained out-of-state care not found in a state with supportive abortion policies.”

For some, it can be an expensive but necessary task.

“If this leaked draft becomes final, it will be earth-shattering and felt hardest for those same communities that are already being disproportionately impacted,” Hopkins said.

“If someone is forced to carry a pregnancy to term, it impacts their economic security and their ability to live the life that they want and raise the family that they maybe already have,” Hopkins said. “The impact will be devastating.”

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(NEW YORK) — As states across the country have passed bans against abortion, more women have had to spend time and money heading across state lines to get the legal procedure.

And with the Supreme Court poised to roll back Roe v. Wade, abortion rights activists told ABC News they fear that it will become near impossible for women in the South and Midwest to get a legal and safe procedure.

Two women who recently had to travel hundreds of miles to get an abortion allowed “Nightline,” to accompany them through the process in hopes that people, including policymakers, can see just how devastating those laws will be to other women in the same situation.

“I feel like people need to know and need to know our side of the story,” said “Marie,” a 31-year-old Texas woman who got an abortion in Tulsa, Oklahoma last month and asked ABC News not to reveal her real name. “We’re not evil. We’re not baby killers.”

After Texas passed its ban on abortions following six weeks in the fall, Marie had to look for health care centers in nearby Oklahoma. The state’s Planned Parenthood centers saw a 2,500% jump in patients from Texas following the ban, according to the non-profit.

Marie told ABC News she had to wait more than a month for an open appointment, had to take a week vacation from her job and had to drive 14 hours straight to the Planned Parenthood center in Tulsa.

“In the car by myself for 14 hours, you definitely have a lot of time to think,” she said. “It’s been really, really hard.”

Marie said she felt more nervous because of news reports of copycat abortion bans that made its way through the Oklahoma State Legislature. Marie was able to get her procedure done before Gov. Kevin Sitt signed a copycat bill into law on May. 3.

“How dare you try and force people to do things the way you want them to do them. It’s our bodies. I feel like women will be desperate, harm themselves,” Marie said.

Nicole, a 39-year-old mother of two who recently traveled to Kansas to get an abortion, also shared that sentiment with “Nightline.” Nicole said that even though she has a full time job and loves being a mom. But she and her partner could not afford to have another child.

Her situation is common among abortion patients, according to health data. The U.S. Centers for Disease Control and Prevention said about 60% of patients who have had an abortion have at least one child.

“I wanted to give a voice to the older women- [who] already have kids, and I want to give an opportunity for the government to see how it affects us,” Nicole told “Nightline” about why she wanted to tell her story.

Nicole was early enough in her pregnancy that she could have a medication abortion, but due to a backlog in Oklahoma she had to drive to Kansas to get the pills. She told “Nightline” that she had to pay for travel, find childcare for her two boys and drive back and forth to the clinic.

Nicole said the experience backed up her concerns about raising another child.

“If I struggle to pay $800, $900 to take care of something like this, how would I be able to take the money, the time, and everything, and take care of a child?” she said.

Kansas could become another state to ban abortions. The right to an abortion is currently protected by the state constitution but the public could vote to restrict it through a ballot initiative scheduled for Aug. 2.

Nicole and Marie told “Nightline” that they are upset that lawmakers aren’t considering the circumstances that women are in when they make decisions regarding abortion rights.

Marie added that her experience has made her want to speak out more.

“I feel like it’s going to affect my life now forever because I’m going to fight more for women in this situation that don’t have any other choices,” she said.

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(WASHINGTON) — The Food and Drug Administration has put limits on the Johnson & Johnson COVID-19 vaccine due to the rare risk of blood clots.

“Today, the U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine,” the FDA said in a statement Thursday.

The announcement follows a recommendation from the Centers for Disease Control and Prevention late last year to opt for either Pfizer or Moderna, over the single-shot J&J vaccine after a review of new CDC data on rare blood clots linked to J&J.

This is a developing story. Please check back for updates.

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(NEW YORK) — Pink is marking Mental Health Awareness Month and sharing her story about suffering from “pretty awful panic attacks” when she was in her early 20s.

“I didn’t know what was happening. I didn’t have anybody to talk to about it and I didn’t know what to do,” the “Just Like Fire” singer admitted in a new Instagram video.

She said her attacks felt “like I was having strokes, like, stroke symptoms. It was terrifying.”

When she went to the hospital for help during the attacks, Pink said she was always told, “You’re fine. There’s nothing wrong. You’re imagining it all. It’s all in your head.”

The “Try” singer said she didn’t take that as a final answer and sought a therapist to help figure out what was causing her issues.

“I started learning all these steps on how to take care of myself,” she said. “I’d never been taught how to take care of myself.”

Pink said she turned to meditating, healthy eating, surrounding herself with the right people and using a “spiritual toolbox” that she keeps under her bed to help manage the panic attacks.

What has helped the most, she noted, is music: “Writing songs is probably the thing that has saved my life.”

“I will tell you – from being a very, very afraid seven-, eight-, 13-, 23-, 31- and now 42-year-old woman – it does get better and there are beautiful moments waiting for you,” she said. “And there are beautiful people waiting to love you, and one of those people is yourself.”

Pink is partnering with the nonprofit Child Mind Institute to promote its “Dare to Share” campaign, which encourages children to be open about their own mental health.

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(NEW YORK) — Little Women: LA creator and star Terra Jolé is opening up about her personal health battle hoping to help others, she says.

Jolé announced her breast cancer diagnosis to fans and her social media followers in an emotional Instagram video post last week.

“I have breast cancer,” the 41-year-old TV personality wrote in the caption. “Hardest call I’ve ever made was this video telling my mom for the first time.”

While she initially felt the cancer on her right side, evidence of cancer was later found in both breasts, Jolé told Good Morning America.

“I had two choices,” Jolé continued. “1. Hide and not share on social media. 2. Take you along the fight with me. Since our lives have been public for the last 10 years, it’s only fair we make this journey together.”

In Jolé’s video post, the Dancing With the Stars alum revealed to her mother that she decided to undergo a double mastectomy, a type of surgery where both breasts are removed, along with cancerous tissue, according to the American Cancer Society. While mastectomies are one of the multiple treatment options for individuals with breast cancer, they are typically reserved for women with high-risk cancers or those who have genetic mutations placing them at increased risk of recurrence.

GMA caught up with Jolé eight days after her surgery, one that she said she opted for to prevent a recurrence of cancer.

“I didn’t want that for my children, I didn’t want to go through this multiple times,” Jolé said. “So I want to take off both now and not think ‘what if’ in the future.”

Jolé has been in the spotlight for years, bringing awareness to skeletal dysplasia, the condition behind her 4′ 2″ stature.

“Showing you’re not alone through an experience like this whether you’re a little whether you’re average, this can happen to anyone,” Jolé told GMA.

“If I had someone like a friend or someone that experienced this in a positive light, then this would have made the beginning process much easier for me.”

As she takes on her breast cancer journey, Jolé said she is leaning on her family for support.

Jolé’s husband, Joe Gnoffo, told GMA he’s in awe of her strength. “I can’t believe how she’s handling this,” he said.

“Never once have I heard like, ‘Why me?’ She’s just not like that.”

Jolé’s main message for others is to pay attention to their own bodies and to get care if needed.

“If you feel something, say something. It can be a matter of life or death for you,” Jolé said.

She also encouraged others not to wait too long to seek advice from a doctor. “Ask your OB if it’s something to take a closer look at!” Jolé wrote in another Instagram post Wednesday.

“If they don’t give you a breast exam in their office, find another OB. My OB (whom I love dearly but…) had a 3 month appointment out, so, I found another OB. I couldn’t wait 3 months to know if I was feeling something normal or not normal.”

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(NEW YORK) — When Laura Martin tested positive for COVID-19 last month during an extended stay in California, she was prescribed Paxlovid, the highly touted antiviral drug created by Pfizer.

Just one day after her diagnosis, she started her five-day course of pills, which have been shown to dramatically reduce the risk of hospitalization and death.

Martin, a 63-year-old Boston native who now resides in Canada, said she was thrilled when her symptoms began to subside.

“By the end of [the treatment], on Day 5, I was negative and feeling completely normal like without any symptoms, so I thought, ‘Wow, this is really great. What a great drug,’” Martin told ABC News.

Martin resumed her normal activities, but a week later, she began to feel ill again. When her symptoms worsened, she tested again.

“It came roaring back, and this round two has been much more severe than round one was,” Martin said. “This is like four days of much more significant symptoms than round one.”

​Martin’s case is part of a seemingly rare, but increasingly reported phenomenon of COVID-19 symptom recurrence after being treated with Paxlovid. While it is largely unknown what is causing the reported viral resurgence, scientists say they are investigating. ​​

Pfizer says that it is taking the reported incidences of recurrence “very seriously,” but that the rates mirror those who received a placebo in clinical trials. Experts urge that the benefits of the drug, in preventing hospitalization and death, outweigh the potential risk of a second positive test or symptom reemergence.

In additional analysis of the Paxlovid clinical trial data, the Food and Drug Administration (FDA) reported that most patients “did not have symptoms at the time of a positive PCR test after testing negative, and, most importantly, there was no increased occurrence of hospitalization or death or development of drug resistance.”

Company executives also reported, this week, that the use of Paxlovid continues to expand rapidly, particularly as infection rates across the country rise again. In the U.S., use of the treatment has increased by nearly ten-fold in recent weeks.

The number of locations in the U.S. with Paxlovid supply has grown to more than 33,000 sites now available, a four-fold increase since late-February. In addition, the company reported that there are now more than 2,200 Test to Treat locations now open.

‘Game-changer’

Long heralded as a “game-changer” in the fight against COVID-19, the push to make Paxlovid available to Americans has ramped up in recent weeks, with the White House looking to increase supply of the treatment.

The drug, which was granted emergency use authorization by the FDA in December 2021 for people with mild to moderate COVID-19 at high risk of disease progression, is also strongly recommended by the World Health Organization. It has been shown to be highly effective, estimated to provide an 89% reduction in virus-related hospitalizations and deaths.

However, in recent weeks, a number of patients, who have taken the treatment, have taken to social media to disclose what they say is a perplexing phenomenon of COVID-19 symptoms reemerging after they finished the prescribed five-day treatment course.

Some individuals claimed on Twitter that after their initial symptoms dissipated, leading to a negative test, they are once again testing positive.

“We’re seeing people get better on Paxlovid,” Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center, told ABC News. “But then, when they stop at the end of five days, we’re hearing stories of symptoms coming back and even, tests becoming either more positive, i.e. a darker line, or tests that had gone negative turning positive.”

Studies have found that a dark line can “indicates a strong positive with a high level of virus and is usually seen when people are at or near peak virus load.”

Reports of these “rebound symptoms” are largely anecdotal so far but with an increasing number of questions about the puzzling viral recurrence, scientists across the country are trying to assess what may be happening in new research.

Pfizer taking reports of viral rebounds ‘very seriously’

In February, a 71-year-old man in Massachusetts who had been vaccinated and boosted recovered after being treated for COVID-19 with Paxlovid, Dr. Michael Charness, chief of staff at the VA Boston Healthcare System, who has been researching the phenomenon and recently put out a preprint study last week, told ABC News.

However, around nine days after his initial positive test, Charness said his patient developed cold symptoms and tested positive again for the virus.

Molecular testing soon revealed that the patient’s viral load had increased to an even higher point than when the diagnosis was first made, according to an analysis by Charness and his team.

“We were interested in whether this was a new infection or whether this was maybe an adaptation or mutation that somehow changed the variant,” Charness said, adding that gene sequencing demonstrated that this second positive test demonstrated a recurrence of the original infection in an individual who had no symptoms for a week.

“We just were very struck by that,” said Charness. “I heard from people all over the country and some from other parts of the world, who had had the same experience.”

Representatives from the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, told ABC News that teams of scientists are investigating the surprising relapse reports, and they will provide further recommendations, if appropriate.

“The phenomenon of recrudescence reiterates the importance of following CDC’s isolation guidance – anyone who develops symptoms of illness during or after isolation should remain isolated, masked, and seek out testing and clinical care,” a representative from the CDC told ABC News in a statement. “Anyone who is concerned about having been exposed or who for any other reason wants to determine their infection status should test for COVID-19.”

The FDA stressed that the reports “do not change the conclusions from the Paxlovid clinical trial which demonstrated a marked reduction in hospitalization and death.”

The viral recurrence had been observed and reported in Pfizer’s application to the FDA, last year, in which the company said several trial participants had appeared to “have a rebound” of COVID-19 around day 10 or day 14.

Pfizer executives said Tuesday that they are taking the reports “very seriously,” but they do not believe that it is related to the drug, given that the same rate of rebound was observed in people who took the placebo. Further, no connection was noted between the viral load increase and subsequent severe illness.

“We’ve taken a preliminary look at our high-risk data, and so we’ve seen for example, that we have about an incidence about 2% of that viral load rebound, but we also see the same, or close to the same, percent in the placebo arm. So it’s something that’s not particularly associated with Paxlovid itself, but may have something to do with the virus itself,” Dr. William Pao, Pfizer’s executive vice president and chief development officer, said during an investors call on Tuesday. “It’s preliminary data so far, we again take it very seriously. But it’s very current, and a very low incidence, and we continue to learn as we go.”

A representative from Pfizer told ABC News that although it is too early to determine the cause, initial indications suggest an increased viral load is both uncommon and not uniquely associated with the Paxlovid treatment.

“We remain very confident in its clinical effectiveness at preventing severe outcomes from COVID-19 in high-risk patients,” the representative said.

Reports uncommon but happening ‘frequently enough’

Although official reports of these relapses still appear to be rare, such occurrences are happening “frequently enough” in those treated with Paxlovid that Charness said that it should be studied further.

“I think the first step in studying something is to know that it exists,” he explained, adding that it is particularly important for clinicians to be informed about potential rebounds, and for the public to know, so that people do not become unduly alarmed.

Thus far, researchers know very little about the reason for the recurring symptoms.

Of critical importance in the investigations is whether an individual, in the midst of such a rebound, remains infectious, Charness said.

“We are sufficiently concerned about whether people can transmit, when they’re on day 12 and 13 and 15, that we are essentially recommending that when people have a recurrence, a rebound, that they restart their isolation, and isolate until their antigen test is negative,” Charness said. “We’re seeing people whose antigen test stays positive for a week after they rebound, which means that they’re well outside the CDC’s 10-day guidance.”

Should you experience a viral rebound, the FDA is now recommending that health care providers and patients refer to CDC guidance, wear a mask and isolate if they have any COVID-19 symptoms — regardless of whether or not they have been treated with an antiviral.

Charness and his team are also encouraging their patients to start their isolation period over again and stay away until their antigen test is negative.

“It’s important to exercise caution until you clear the virus the second time,” Charness said, further urging people to notify their provider.

In terms of further treatments, Charness noted it is still largely unclear what patients should do. While there are no limitations, within the authorized label, around additional usage of the drug for a subsequent COVID-19 infection, according to Pfizer, the FDA said “there is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”

Despite the reports of rebounding, health experts stress that Paxlovid is still largely achieving its original goal, to keep people out of the hospital, and severe disease at-bay.

“The bottom line is if it prevents hospitalization, if it keeps you from progressing to severe disease, hospitalization and death, the fact that you might have a recurrence of some of the symptoms and even the recurrence of a positive test is sort of secondary,” said Doron. “The main thing is Paxlovid is to prevent progression to severe disease [and] hospitalization, and it does. So, it’s still doing its job.”

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(NEW YORK) — When Laura Martin tested positive for COVID-19 last month during an extended stay in California, she was prescribed Paxlovid, the highly touted antiviral drug created by Pfizer.

Just one day after her diagnosis, she started her five-day course of pills, which have been shown to dramatically reduce the risk of hospitalization and death.

Martin, a 63-year-old Boston native who now resides in Canada, said she was thrilled when her symptoms began to subside.

“By the end of [the treatment], on Day 5, I was negative and feeling completely normal like without any symptoms, so I thought, ‘Wow, this is really great. What a great drug,’” Martin told ABC News.

Martin resumed her normal activities, but a week later, she began to feel ill again. When her symptoms worsened, she tested again.

“It came roaring back, and this round two has been much more severe than round one was,” Martin said. “This is like four days of much more significant symptoms than round one.”

​Martin’s case is part of a seemingly rare, but increasingly reported phenomenon of COVID-19 symptom recurrence after being treated with Paxlovid. While it is largely unknown what is causing the reported viral resurgence, scientists say they are investigating. ​​

Pfizer says that it is taking the reported incidences of recurrence “very seriously,” but that the rates mirror those who received a placebo in clinical trials. Experts urge that the benefits of the drug, in preventing hospitalization and death, outweigh the potential risk of a second positive test or symptom reemergence.

In additional analysis of the Paxlovid clinical trial data, the Food and Drug Administration (FDA) reported that most patients “did not have symptoms at the time of a positive PCR test after testing negative, and, most importantly, there was no increased occurrence of hospitalization or death or development of drug resistance.”

Company executives also reported, this week, that the use of Paxlovid continues to expand rapidly, particularly as infection rates across the country rise again. In the U.S., use of the treatment has increased by nearly ten-fold in recent weeks.

The number of locations in the U.S. with Paxlovid supply has grown to more than 33,000 sites now available, a four-fold increase since late-February. In addition, the company reported that there are now more than 2,200 Test to Treat locations now open.

‘Game-changer’

Long heralded as a “game-changer” in the fight against COVID-19, the push to make Paxlovid available to Americans has ramped up in recent weeks, with the White House looking to increase supply of the treatment.

The drug, which was granted emergency use authorization by the FDA in December 2021 for people with mild to moderate COVID-19 at high risk of disease progression, is also strongly recommended by the World Health Organization. It has been shown to be highly effective, estimated to provide an 89% reduction in virus-related hospitalizations and deaths.

However, in recent weeks, a number of patients, who have taken the treatment, have taken to social media to disclose what they say is a perplexing phenomenon of COVID-19 symptoms reemerging after they finished the prescribed five-day treatment course.

Some individuals claimed on Twitter that after their initial symptoms dissipated, leading to a negative test, they are once again testing positive.

“We’re seeing people get better on Paxlovid,” Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center, told ABC News. “But then, when they stop at the end of five days, we’re hearing stories of symptoms coming back and even, tests becoming either more positive, i.e. a darker line, or tests that had gone negative turning positive.”

Studies have found that a dark line can “indicates a strong positive with a high level of virus and is usually seen when people are at or near peak virus load.”

Reports of these “rebound symptoms” are largely anecdotal so far but with an increasing number of questions about the puzzling viral recurrence, scientists across the country are trying to assess what may be happening in new research.

Pfizer taking reports of viral rebounds ‘very seriously’

In February, a 71-year-old man in Massachusetts who had been vaccinated and boosted recovered after being treated for COVID-19 with Paxlovid, Dr. Michael Charness, chief of staff at the VA Boston Healthcare System, who has been researching the phenomenon and recently put out a preprint study last week, told ABC News.

However, around nine days after his initial positive test, Charness said his patient developed cold symptoms and tested positive again for the virus.

Molecular testing soon revealed that the patient’s viral load had increased to an even higher point than when the diagnosis was first made, according to an analysis by Charness and his team.

“We were interested in whether this was a new infection or whether this was maybe an adaptation or mutation that somehow changed the variant,” Charness said, adding that gene sequencing demonstrated that this second positive test demonstrated a recurrence of the original infection in an individual who had no symptoms for a week.

“We just were very struck by that,” said Charness. “I heard from people all over the country and some from other parts of the world, who had had the same experience.”

Representatives from the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, told ABC News that teams of scientists are investigating the surprising relapse reports, and they will provide further recommendations, if appropriate.

“The phenomenon of recrudescence reiterates the importance of following CDC’s isolation guidance – anyone who develops symptoms of illness during or after isolation should remain isolated, masked, and seek out testing and clinical care,” a representative from the CDC told ABC News in a statement. “Anyone who is concerned about having been exposed or who for any other reason wants to determine their infection status should test for COVID-19.”

The FDA stressed that the reports “do not change the conclusions from the Paxlovid clinical trial which demonstrated a marked reduction in hospitalization and death.”

The viral recurrence had been observed and reported in Pfizer’s application to the FDA, last year, in which the company said several trial participants had appeared to “have a rebound” of COVID-19 around day 10 or day 14.

Pfizer executives said Tuesday that they are taking the reports “very seriously,” but they do not believe that it is related to the drug, given that the same rate of rebound was observed in people who took the placebo. Further, no connection was noted between the viral load increase and subsequent severe illness.

“We’ve taken a preliminary look at our high-risk data, and so we’ve seen for example, that we have about an incidence about 2% of that viral load rebound, but we also see the same, or close to the same, percent in the placebo arm. So it’s something that’s not particularly associated with Paxlovid itself, but may have something to do with the virus itself,” Dr. William Pao, Pfizer’s executive vice president and chief development officer, said during an investors call on Tuesday. “It’s preliminary data so far, we again take it very seriously. But it’s very current, and a very low incidence, and we continue to learn as we go.”

A representative from Pfizer told ABC News that although it is too early to determine the cause, initial indications suggest an increased viral load is both uncommon and not uniquely associated with the Paxlovid treatment.

“We remain very confident in its clinical effectiveness at preventing severe outcomes from COVID-19 in high-risk patients,” the representative said.

Reports uncommon but happening ‘frequently enough’

Although official reports of these relapses still appear to be rare, such occurrences are happening “frequently enough” in those treated with Paxlovid that Charness said that it should be studied further.

“I think the first step in studying something is to know that it exists,” he explained, adding that it is particularly important for clinicians to be informed about potential rebounds, and for the public to know, so that people do not become unduly alarmed.

Thus far, researchers know very little about the reason for the recurring symptoms.

Of critical importance in the investigations is whether an individual, in the midst of such a rebound, remains infectious, Charness said.

“We are sufficiently concerned about whether people can transmit, when they’re on day 12 and 13 and 15, that we are essentially recommending that when people have a recurrence, a rebound, that they restart their isolation, and isolate until their antigen test is negative,” Charness said. “We’re seeing people whose antigen test stays positive for a week after they rebound, which means that they’re well outside the CDC’s 10-day guidance.”

Should you experience a viral rebound, the FDA is now recommending that health care providers and patients refer to CDC guidance, wear a mask and isolate if they have any COVID-19 symptoms — regardless of whether or not they have been treated with an antiviral.

Charness and his team are also encouraging their patients to start their isolation period over again and stay away until their antigen test is negative.

“It’s important to exercise caution until you clear the virus the second time,” Charness said, further urging people to notify their provider.

In terms of further treatments, Charness noted it is still largely unclear what patients should do. While there are no limitations, within the authorized label, around additional usage of the drug for a subsequent COVID-19 infection, according to Pfizer, the FDA said “there is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”

Despite the reports of rebounding, health experts stress that Paxlovid is still largely achieving its original goal, to keep people out of the hospital, and severe disease at-bay.

“The bottom line is if it prevents hospitalization, if it keeps you from progressing to severe disease, hospitalization and death, the fact that you might have a recurrence of some of the symptoms and even the recurrence of a positive test is sort of secondary,” said Doron. “The main thing is Paxlovid is to prevent progression to severe disease [and] hospitalization, and it does. So, it’s still doing its job.”

Copyright © 2022, ABC Audio. All rights reserved.

(NEW YORK) — Amid a nationwide wave of what they call legislation targeting LGBTQ rights and representation, advocates are concerned about the impact on the mental health of LGBTQ youth.

“LGBTQ youth suicide is a major public health crisis,” said Amit Paley, chief operating officer of The Trevor Project, a nonprofit focused on suicide prevention among LGBTQ youth.

This population already struggles disproportionately with mental illness and suicide. The Centers for Disease Control and Prevention reports LGBTQ students are about four times more likely to have attempted suicide than their heterosexual peers, according to a study released in late March that tracked data from 2009 to 2019.

That same study showed LGBTQ youth self-reported persistent feelings of sadness or hopelessness at more than twice the rate of their heterosexual peers.

Matthew Goldenberg, a psychologist at the Seattle Children’s Hospital Gender Clinic, explained that additional everyday “environmental factors” create a higher prevalence of suicide attempts and suicidal thoughts among LGBTQ youth.

He cited family conflicts, heightened stress, lack of community support, bullying and whether or not a child has an affirming environment as potential risk factors.

“I think the really important point to make is that LGBTQ young people are not born inherently more likely to attempt or consider suicide,” Paley said. “LGBTQ young people end up attempting or considering suicide because of the stigma and discrimination and isolation that they face in society.”

Paley explained The Trevor Project has been monitoring an upward trend in reported suicidal thoughts and suicide attempts among this population over the last few years.

“And that coincides with a really difficult time for so many LGBTQ young people, as they are being attacked in legislative contexts,” Paley said.

More than 300 bills targeting LGBTQ people have been introduced so far this year, according to the Human Rights Campaign.

“When you hear people in positions of power saying people can’t talk about your identity in schools, that you can’t use the restroom, that you can’t access medical care. That’s very scary,” Paley said. “Those policies are harmful and dangerous, but even more than that, the words around them really impact the mental health of LGBTQ youth.”

Along with the impacts of hostile legislation, LGBTQ young people are feeling the mental health effects of the COVID-19 pandemic, which has heightened attention on mental health concerns across the nation over the last two years.

“The pandemic has been incredibly difficult for LGBTQ youth, who may not be able to live as their authentic selves when they’ve been home so much during the last few years, and that’s really exacerbated the mental health crisis among that population,” said Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness.

On Tuesday, co-chair of the congressional LGBTQ+ Equality Caucus, Rep. Sharice Davids, D-Kansas, introduced the Pride in Mental Health Act. The bill would create a new program at the Substance Abuse and Mental Health Services Administration (SAMHSA) to “assess and improve LGBTQ+ youth mental health,” according to a press release from the caucus.

The legislation would also amend the Child Abuse Prevention and Treatment Act to provide specific protections for LGBTQ youth with the aim of improving data collection related to abuse and neglect among that population.

“Mental health is a growing concern for families and communities across the country, and frankly, we are failing many of our most vulnerable children on this issue,” Davids said in a press release. “When we talk about improving mental health, we’re really talking about saving these kids’ lives.”

Resources to support LGBTQ young people experiencing mental health crises are available. The Trevor Project offers a crisis line via phone, text and online chat for LGBTQ young people. Trans Lifeline operates a peer support and crisis line for transgender people.

The National Suicide Prevention Lifeline offers crisis support services as well. In July, that hotline will transition to a new three-digit number, 988, that advocates envision as the mental health equivalent of 911.

The Trevor Project was among the advocates for the establishment of the new number for the Lifeline. Paley says the organization is working with the Department of Health and Human Services SAMHSA to create an integration in the Lifeline service to connect LGBTQ young people who call in to counselors specifically trained to support and understand their needs.

“I think the biggest thing about providing these crisis resources is they need to be culturally competent,” Wesolowski said. “Somebody who identifies as LGBTQ talking to somebody who can understand their experience is really important to de-escalating that.”

There is no current timeline for when that integration with the Lifeline will be up and running. Efforts to get the new number launched are still underway and complicated by underfunding.

“We think the intention of 988 is so incredibly important,” Paley said. “We need to make sure that the federal government puts the resources to execute it properly. And so that’s what we’re in discussions about to make sure that we can provide more access for LGBTQ youth.”

If you are struggling with thoughts of suicide or worried about a friend or loved one, help is available. Call the National Suicide Prevention Lifeline at 1-800-273-8255 [TALK] for free, confidential emotional support 24 hours a day, 7 days a week. You can also reach the Trevor Project at 1-866-488-7386 or the Crisis Text Line by texting “START” to 741741.

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