Health

(NEW YORK) — Consumers are being warned against using more than two dozen eye drop products sold over-the-counter at major retailers including CVS, Target and Rite Aid.

The U.S. Food and Drug Administration says the eye drop products were manufactured in a facility with “insanitary conditions” and carry a “potential risk of eye infections that could result in partial vision loss or blindness.”

“These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the FDA said in a news release Friday. “FDA recommended the manufacturer of these products recall all lots on October 25, 2023, after agency investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility.”

The impacted products are marketed under the brands CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma, according to the FDA, which shared a full list of the 26 products on its website.

The federal agency says consumers should “immediately stop using” the products and dispose of them properly, which includes either dropping off the product at a drug take back site or following the FDA’s steps to dispose the product in the trash.

The FDA also says that consumers should not purchase any of the 26 impacted products if they see them on store shelves.

The agency noted it has not yet received any reports of eye infections caused by the eye drop products, but is encouraging health care professional and patients to report any “adverse events or quality problems.”

Target, Rite Aid and CVS are removing the eye drop products from their stores and websites, according to the FDA.

Products branded as Leader, Rugby and Velocity “may still be available” in stores and online and consumers should not purchase those products, the FDA said.

Cardinal Health, the company behind the brands Rugby and Leader, told ABC News it is working to “initiate a recall” of its impacted products.

“FDA notified us of a possible eye infection risk affiliated with some of our Rugby Laboratories and Leader branded eye care products, and immediately upon being notified, we placed all identified impacted eye drop products in our inventory on hold and contacted Velocity Pharma, the supplier of the impacted eye drop products,” Cardinal Health said in a statement. “We are in the process of working with Velocity Pharma and FDA to initiate a recall of all impacted Rugby Laboratories and Cardinal Health Leader branded eye drop products to further safeguard public health and safety.”

The statement continued, “We take FDA’s consumer notification regarding the risk of using impacted Rugby Laboratories and Leader branded eye drop products very seriously. We are working with Velocity Pharma, the supplier of the impacted eye drop products to gain additional insight regarding the unsanitary conditions identified by the FDA at the manufacturing facility.”

Rite Aid confirmed to ABC News that it is removing its impacted products from stores, saying in a statement, “Due to safety concerns identified by the FDA, we are removing the applicable Rite Aid branded products from our store shelves.”

CVS told ABC News the company is offering customers a full refund if they purchased an impacted product.

“Upon receiving notification by FDA, we’ve immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio,” CVS said in a statement. “Customers who purchased these products can return them to CVS Pharmacy for a full refund. We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers, and are fully cooperating with the FDA on this matter.”

ABC News also reached out to Target and Velocity Pharma for comment.

 

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(NEW YORK) — The issue was first brought to the FDA’s attention when health officials in North Carolina were investigating elevated blood lead levels in four children and found that the WanaBana apple cinnamon pouches could be the common source.

The North Carolina Department of Health and Human Services (NCDHHS) subsequently analyzed “multiple lots” of the WanaBana apple cinnamon fruit puree pouches and detected “extremely high concentrations of lead,” according to the FDA warning.

“The FDA has reviewed and supports NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity,” the FDA advisory declares, adding that they shared the findings with WanaBana, which has “agreed to voluntarily recall all WanaBana apple cinnamon fruit puree pouches regardless of expiration.”

The products were sold at retailers including Sam’s Club, Amazon and Dollar Tree.

“Parents and caregivers of toddlers and young children who may have consumed WanaBana apple cinnamon fruit puree pouches should contact their child’s healthcare provider about getting a blood test,” the FDA urged.

Experts say it can be difficult to detect lead exposure in kids, because sometimes there are no obvious signs. However, the FDA says symptoms of short-term lead exposure can include headache, abdominal pain and vomiting, with longer-term exposure symptoms also potentially including fatigue, irritability, constipation, muscle aches or a sensation of prickling/burning, and more.

Lead exposure can only be properly diagnosed via a blood sample, according to the Centers for Disease Control and Prevention. The FDA says anyone who notices possible lead poisoning symptoms should contact their doctor immediately.

“No safe blood lead level in children has been identified,” according to the CDC . “Even low levels of lead in blood have been shown to negatively affect a child’s intelligence, ability to pay attention, and academic achievement,” the agency stated, adding that lead exposure happens when a child contacts it by “touching, swallowing, or breathing in lead or lead dust.”

 

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(NEW YORK) — Older adults who received last year’s COVID booster and a high-dose version of the flu vaccine in the same visit may have a potential increased risk of stroke, according to a new study funded by the Food and Drug Administration.

Experts urged that the results were preliminary and may be explained by other factors such as the fact that older adults are already at a higher risk for stroke due to their age.

“There is no need for panic, and emphatically no need to stop giving COVID and flu shots at the same time to older adults,” said Dr. Peter Chin-Hong, an infectious diseases specialist at the University of California, San Francisco, while he reiterated that more research is needed.

The results were also not yet peer-reviewed, meaning it hasn’t been vetted in the normal scientific process.

“These data should be considered by patients and their physicians, but there is no reason for alarm. The increased risk of stroke appears to be small and must be balanced against the known benefit of these vaccines in elderly individuals,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.

Last year, health authorities noted a safety signal for ischemic stroke in adults over the age of 65 after receiving the bivalent COVID vaccine, prompting further research.

“Additional data are needed before we can consider these findings definitive. It is good that the FDA has made these safety data available to inform the public,” Barouch said.

There was about a 20-35% increased stroke risk in older adults that received both shots in the same visits, according to the study.

“I don’t know that the risk is very meaningful on an individual patient basis,” said Dr. Amesh Adalja, an infectious disease specialist at the Johns Hopkins University Center for Health Security.

Infection from COVID and flu also have been shown to increase risk of stroke as well as a host of other life-threatening outcomes linked to respiratory illnesses like pneumonia, according to Chin-Hong.

The Food and Drug Administration told ABC News in part of a statement that they remain, “confident in the safety, effectiveness and quality of the COVID-19 vaccines that the agency has authorized and approved.”

“The review conducted in this preprint paper is part of our ongoing safety surveillance efforts, which utilize a variety of data sources,” the statement continued.

The Centers for Disease Control and Prevention reiterated that current vaccine guidance remains the same.

“The COVID-19 vaccines meet the FDA’s and CDC’s very high safety standards. Hundreds of millions of people in the United States have safely received COVID vaccines under the most intense safety monitoring in U.S. history,” the agency said in part of a statement.

Experts reiterated patients should turn to their health care provider to learn about the benefits and potential risks of vaccination. Older adults choosing to get both the flu and COVID shot at the same time for convenience or in two separate visits are both reasonable decisions, Adalja explained.

“For now, I will not dissuade my mom from getting both the high dose flu shot or the COVID shot, even at the same time,” Chin-Hong said.

“Ultimately we need ongoing data in other countries and in future years to inform best practice,” he added.

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(NEW YORK) — Walking 10,000 steps per day is known to improve a person’s health, but reaching that goal can be difficult for many, considering it’s the equivalent of walking around 5 miles.

Now, new research is showing more efficient ways to get similar health benefits without devoting at least an hour per day to walking.

Taking the stairs is one way, according to a study of over 450,000 adults.

The study, published in the medical journal Atherosclerosis, found that climbing five flights of stairs per day — or around 50 steps — lowered the risk of cardiovascular disease by 20%.

In addition, the same benefits are found when the climbing is broken up into smaller segments throughout the day, versus climbing five flights at once, the study found.

“If you choose one flight of stairs, you go up it two to three times a day,” said ABC News medical correspondent Dr. Darien Sutton, an emergency medicine physician, who was not involved in the study. “If you’re working in an office, choose a bathroom that’s on a different floor.”

Sutton noted that in addition to helping to reduce the risk of cardiovascular disease, climbing stairs can also help reduce the risk of diabetes and can help improve muscle strength.

Another study, published Tuesday in the British Journal of Sports Medicine, echoed the findings that short bursts of activity can do the body good.

The study found that just 20 to 25 minutes per day of vigorous movement — activities like walking briskly, jogging and cycling — can help a person live longer.

On the flip side, people who spend most of their day sedentary, either lying or sitting down with less than 20 minutes of activity, had an increased mortality risk of as much as 40%, the study found.

“It’s just an example that movement is a true key to longevity,” Sutton said of the study, in which he was not involved. “And it only takes a couple of minutes a day just to get that benefit.”

The U.S. Centers for Disease Control and Prevention currently recommends that adults get 150 minutes of moderate-intensity physical activity per week, which is the equivalent of 30 minutes a day, five days per week.

The CDC also recommends that adults get two days of muscle strengthening activity per week.

And the CDC also says adults do not have to do all 30 minutes of exercise daily at one time, noting, “You can spread your activity out during the week and break it up into smaller chunks of time.”

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(NEW YORK) — While there have been warnings about the state of children and teenagers’ mental health over the past several years, a new report says another age demographic is suffering even more.

Adults ages 18 to 25 are nearly twice as likely as teenagers to suffer from anxiety and depression, according to data released Tuesday by the Making Caring Common project, an initiative of Harvard University’s Graduate School of Education.

The project’s survey of more than 700 young adults found that more than half said financial worries and the pressure to achieve had “negatively influenced their mental health.”

In addition, 58% of respondents said they lacked “meaning or purpose in their lives.”

Dr. Richard Weissbourd, a psychotherapist on the faculty of Harvard’s Graduate School of Education, who directed the study, told ABC News’ Deborah Roberts that young adults are experiencing a “high rate of loneliness.”

“I think it’s a world that seems off the rails to them. I think it’s unclarity about their job prospects,” Weissbourd said of the obstacles young people face. “And I think social media turbocharged us all of this.”

In addition to finding that young adults lack meaning in their lives, the survey also found that 34% of respondents reported feeling loneliness and 44% reported feeling a sense of not mattering to others.

Audrey McNeal, a 21-year-old college student studying political science, told Roberts that while she and other people her age may have more access to connection than ever thanks to the internet, it’s not the same emotionally as connecting with people in-person.

“I remember my parents telling me about bowling leagues and being able to go to the mall and then doing things like that in real life,” said McNeal. “But now when you meet someone, you exchange Instagrams.”

McNeal said that she and other young people around her age feel the pressure of “a lot of things that can make us overwhelmed and stressed out.”

For Daria Paulis, a 23-year-old who works in a research lab, that pressure includes figuring out logistics like where she can afford to live.

Tarun Amasa, who is also in his early 20s, said he feels the pressure of trying to start his life in a time when “everyone is super ambitious.”

“Everyone is super ambitious and that creates a little bit of a toxic environment where people feel like it’s a very comparative space,” he told ABC News.

Despite the statistics and the odds that young people face, Weissbourd said it is not all bad news for this next generation.

One benefit, he said, is that even with their high rates of mental health struggles, young adults are more willing to speak out about the issue of mental health, which makes a difference.

According to the Centers for Disease Control and Prevention, around 5% of adults age 18 and older report regular feelings of depression, while around 12% report regular feelings of anxiety or worry.

“I think this is a very psychologically aware generation,” Weissbourd said. “They’re very articulate about their feelings, and they may break the stigma about mental health that we have in this country.”

The young people Roberts spoke with said they too have “major hope” in their generation.

“It’s how people make connections, right,” Paulis said of speaking openly about mental health. “It’s like, ‘You have anxiety? Oh my gosh, me too.'”

Added Amasa, “Everyone really is more used to showing their emotions on their sleeve. I think that’s a really good step in the right direction.”

If you are struggling with thoughts of suicide or worried about a friend or loved one, call or text the Suicide & Crisis Lifeline at 988 for free, confidential emotional support 24 hours a day, seven days a week.

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(NEW YORK) — For decades, scientists have been studying why some people experience prolonged illnesses in the wake of even mild infections. Now, due to the millions of people suffering from a similar phenomenon after COVID-19 infection, new funding and research efforts are beginning to unlock some of the mysteries that can help explain long flu, long cold and long COVID.

According to Dr. Todd Ellerin, chief of infectious diseases at South Shore Health, about 8 million people suffer from complications of long COVID, which can include a fast heart rate, brain fog and chronic shortness of breath that persist months after initial infection.

However, post-viral illness is not a new phenomenon. Long COVID raises awareness of many other infectious diseases that are associated with post-viral illness, including infectious mononucleosis and Lyme disease.

“Regardless of the virus, an individual can continue to experience symptoms weeks or even months after the acute phase of the initial infection,” Dr. Syra Madad, an infectious disease epidemiologist, said.

These symptoms are significant enough that they can impact an individual’s quality of life, whether it’s going out to work, going out for social events or simply being able to do daily activities.

Chronic fatigue syndrome is another post-viral illness that was prevalent long before the COVID era. It’s defined as debilitating fatigue that lasts at least six months, with the exclusion of alternate causes of fatigue.

“The first thing that’s important is to actually recognize the illness is real,” said Dr. William Schaffner, professor of medicine at Vanderbilt University’s Division of Infectious Diseases. Historically, patients with chronic fatigue syndrome were regarded with great skepticism — even by doctors.

Many of these syndromes appear as “invisible” illnesses, Ellerin said. “There’s a disconnect between the findings and what the patient is complaining about. When we do testing of blood or imaging or X-rays, everything comes back normal. We don’t know the exact causes of these syndromes, we don’t know exactly what to treat with, and it’s frustrating.”

“Imagine being in bed for 18 hours a day,” Ellerin continued. “That’s what we’re talking about. It’s hard to look patients in the eyes and know that you don’t know how to cure their problem.”

Despite decades of frustration, new research funding set aside for long COVID patients is offering hope for the future and can help guide therapeutics.

According to Ellerin, it’s important to put a name to the diagnosis, even in the midst of uncertainty.

“If you don’t put a name on it, then how are you going to define it, and if you can’t define it, how are you going to research it?” Ellerin asked.

Researchers at the Perelman School of Medicine at the University of Pennsylvania recently found that long COVID patients had different levels of chemicals in their body compared to those who had recovered, the most significant of which were levels of serotonin.

“Reduced serotonin levels, that’s an association. That doesn’t mean it’s the answer, but maybe if we replace their serotonin, maybe they’ll do better,” Ellerin said.

In the meantime, effective therapies can help patients feel better. That could include lung exercises, heart exercises, pain management, physical therapy and mental health therapy.

The emergence and severity of long COVID has led not only to scientific research but to the creation of many clinics across the United States, one of them at the University of Pittsburgh Medical Center. Patients are eligible to be seen in the clinic if they are at least 8 weeks from their initial COVID diagnosis. Approximately 60% of patients are self-referred. Long COVID experts partner with consultants in pulmonary/sleep medicine, cardiology, neurology and physical medicine, as well as rehabilitation, physical and occupational therapy, and mental health therapy.

According to Schaffner, treatments are largely “supportive,” targeting symptoms. For aches and pains, physical therapy has helped patients cope and respond rapidly. For brain fog, patients are given various psychological exercises and short-term memory training to help them concentrate and focus on tasks.

For patients with unexplained exercise limitations, Dr. Michael Risbano, assistant professor of medicine, at the University of Pittsburgh Medical Center’s Department of Pulmonary and Critical Care Medicine, can perform Advanced Cardiopulmonary Exercise Testing (ACPET), a minimally invasive procedure performed at the cardiac catheterization lab. This test helps find different causes and treatments for exercise limitation in patients with long COVID and can help them get back to their baseline level of physical function.

For many of these post-viral diseases, experts said it’s important to reduce the risk of developing illness in the first place by staying up to date on vaccinations.

“I don’t think people appreciate that enough. These vaccines are not just for your acute phase of infection, but even in the long run, it’s decreasing your chances of experiencing some long chronic issues,” Madad said.

COVID-19 and flu vaccines are available and recommended for the upcoming winter respiratory virus season. RSV shots are also available for older adults, infants and some pregnant women.

In the meantime, Madad said it’s important for doctors to stay up to date on the best way to care for patients with post-viral illness.

“There are patients that are really debilitated because of this,” Ellerin said. “We’re talking about millions and millions of people around the world.”

And as doctors continue to search for effective treatments, Shaffner said, “It is important for physicians to recognize disease, be empathetic with patients, and let them know that you as a doctor will be there with them, caring for them as best as you can. That comforts the patients. That’s something they can almost literally hold on to.”

Krupa V. Patel, M.D., is a resident physician in anesthesiology at the University of Pittsburgh Medical Center and a member of the ABC News Medical Unit.

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(NEW YORK) — An already-approved chemotherapy drug could reduce the risk of dying of cervical cancer when added to the current treatment standard, according to new research presented at a major medical conference.

The study, presented at the European Society for Medical Oncology, followed 500 people, most of whom had “locally advanced” cervical cancer that hadn’t yet spread to other body parts.

Half of the patients were treated with chemoradiation — the current gold standard for treatment, researchers said. The other half were given combination therapy that included a pre-dose (or induction dose) of chemotherapy before every session of chemoradiation.

The study found that the group who got the additional chemotherapy survived longer, on average. After 5 years, 80% of these women were still alive, compared to 72% of those who got the standard treatment, according to the study.

Almost all patients in the study experienced some side effects consistent with these types of cancer treatments.

The researchers suggested that their new strategy of giving an early pre-dose of chemo, plus the standard combo of chemo and radiation, should become the new standard.

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(NEW YORK) — Health care workers are facing a severe mental health crisis, according to a new survey published Tuesday by the Centers for Disease Control and Prevention.

Workers said they are experiencing harassment, burnout, and other mental health symptoms — including anxiety and depression — at levels higher than before the start of the COVID-19 pandemic.

“Health workers and health-related professions have historically faced long work hours, often with unpredictable or rotating schedules or like what I experienced as an emergency physician working overnights and on holidays,” Dr. Debra Houry, the CDC’s chief medical officer, said during a press conference about the report Tuesday afternoon.

“Caring for people who are sick can also be intensely stressful and emotional. Exposure to human suffering takes an immense toll on this vital workforce,” she continued.

The CDC analyzed data from the General Social Survey Quality of Worklife Module — conducted by the National Opinion Research Center at the University of Chicago — to compare self-reported mental health symptoms from 2018 to 2022.

Over the course of four years, health care workers saw an increase in poor mental health during the past 30 days from 3.3 days to 4.5 days. This increase was higher than among workers in other professions.

The percentage of workers who reported feeling burnout very often increased from 11.6% in 2018 to 19.0% in 2022.

In total, 45.6% of health workers reported feeling burnout often or very often in 2022 compared to 31.9% in 2018.

Harassment was another major issue facing health care workers. More than double the number of workers reported harassment at work in 2022 compared to 2018.

This harassment included threats, bullying, verbal abuse, or actions from patients or coworkers leading to a hostile work environment, according to the report.

The survey also found that those who experienced harassment at work were more likely to experience feelings of anxiety, depression, and burnout.

For example, 31% of health care workers reported feeling depressed who did not experience harassment compared to 60% of workers who did experience harassment.

The CDC says this report is the first to describe and compare the well-being and working conditions of health workers and that the COVID pandemic may have presented unique challenges that worsened workers’ mental health and led many to leave or with plans to leave their jobs.

Dr. L. Casey Chosewood, director of the CDC’s National Institute for Occupational Safety and Health’s Office for Total Worker Health, said that he believes many felt that health care workers were immune to many of the challenges that face other workers.

“They’re incredibly resilient as the workforce but, at the end of the day, health workers are human and they’re telling us as we listen to their stories that they really can’t do anymore and that we must address the long-standing systemic issues that have been at play here,” he said during the press conference.

Health care workers were less likely to report feelings of burnout if they reported trusting management, had help from a supervisor, had time to complete their work, and felt that their workplace supported productivity.

To improve working conditions, the CDC says employers can allow their health workers to participate in decision-making including on how work is done and what aspects could be improved.

The study showed that health workers experienced a decrease in the likelihood of feeling burned out if they trusted management, had supervisor help, had enough time to complete work, and felt that their workplace supported productivity, compared with those who did not have these things.

“There is hope,” Chosewood said. “The Vital Signs report noted that poor mental health outcomes are less common when working conditions are positive and where health workers have the potential to thrive.”

He said that a “supportive work environment had a positive impact on health workers. For example, the data shows that the odds of depression symptoms were half when health workers could take part in workplace decisions.”

Employers should also carefully monitor staffing needs and pay attention to harassment reports, Houry said.

“Designing work and policies to support workers can help workers feel safe and protect their mental health,” Houry said.

ABC News’ Dr. Liz Ghandakly contributed to this report.

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(NEW YORK) — Moderna announced Tuesday it has dosed its first participant in a phase III clinical trial of a combination influenza and COVID-19 vaccine.

This phase will evaluate the safety and efficacy of the combo vaccine compared to flu and COVID vaccines that are administered separately in two groups, one involving 4,000 adults aged 65 and older and another involving 4,000 adults between ages 50 and 64.

In earlier Phase I/II clinical trials, data showed that the vaccine candidate achieved antibody levels similar or greater to the licensed standalone influenza vaccine and to Moderna’s COVID vaccine.

In a press release, the biopharmaceutical company said the combination vaccine has “the potential to efficiently reduce the overall burden of acute viral respiratory disease” by giving simultaneous protection against flu and COVID in a single dose.

Moderna said this could benefit the public health by increasing vaccine coverage rates for both viruses due to the convenience and easy administration of getting two shots at once.

The company previously announced that it is aiming for regulatory approval for the combination vaccine in 2025.

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

“Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies,” Moderna CEO Stéphane Bancel said earlier this month in a statement when phase I/II clinical trial data was released. “Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems.”

Moderna estimated between 50 and 100 million COVID vaccine doses will be administered this fall and that, with time, the COVID market will approach the influenza market in the U.S.

Currently, between 500 million and 600 million flu shot doses are administered around the world with 150 million occurring in the U.S., according to Moderna.

Earlier this month, Moderna also said the rates of adverse reactions were not serious and similar to those experienced by the study participants who received the COVID vaccine by itself.

Moderna is not the only company that has been investigating a flu-COVID combination vaccine.

Pfizer-BioNTech announced in November 2022 that it had begun phase I clinical trials and, a month later, announced it had been given Fast Track designation by the U.S. Food and Drug Administration to help expedite the development and review of new drugs.

Pfizer previously told investors during an earnings call in January 2023 that a successful COVID-flu combination vaccine could help increase the percentage of Americans who receive a COVID vaccine.

Novavax also announced it is currently in the process of phase I/II clinical trials. In May 2023, the company said data showed there was a robust immune response among study participants.

Public health officials encourage anyone 6 months and older to get their annual flu and COVID-19 shots to minimize the risk for severe illness.

 

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(NEW YORK) — Dozens of states are taking action Tuesday against Meta, formerly known as Facebook, for allegedly harming young people’s mental health.

A federal lawsuit and parallel state lawsuits allege that Meta knowingly designed and deployed harmful features on Instagram and Facebook that purposefully addict children and teens.

The states also allege Meta routinely collects data on children under 13 without informing parents or obtaining parental consent.

“Its motive is profit, and in seeking to maximize its financial gains, Meta has repeatedly misled the public about the substantial dangers of its Social Media Platforms,” the lawsuit said. “It has concealed the ways in which these Platforms exploit and manipulate its most vulnerable consumers: teenagers and children. And it has ignored the sweeping damage these Platforms have caused to the mental and physical health of our nation’s youth. In doing so, Meta engaged in, and continues to engage in, deceptive and unlawful conduct in violation of state and federal law.”

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

 

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