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Heart Risk Factors Show Up Earlier in U.S. Black Women

THURSDAY, May 6, 2021 (HealthDay News) -- Young Black American women have high rates of lifestyle-related risk factors for heart disease, a new study indicates.

The findings show the need to help them adopt healthy eating and physical activity habits, as well as make it easier for them to access health care, the researchers said.

"Young people should be the healthiest members of our population, with normal body weight and normal blood pressure," said study author Dr. Nishant Vatsa, an internal medicine resident at Emory University Hospital in Atlanta.

"Diet and exercise play a major role in blood pressure and weight. Primary care providers, prevention-based clinics and community organizations can facilitate interventions proven to mitigate these risk factors," Vatsa said. "Providers that treat young Black women need to be mindful of cardiovascular preventive care and be armed with resources and education."

In the study, Vatsa's team analyzed data gathered between 2015 and 2018 from 945 Black women enrolled in a community health screening project in Atlanta. The average body mass index (BMI -- an estimate of body fat based on weight and height) in all age groups was 30, which is considered obese.

Systolic blood pressure -- the top number in a reading and a measure of the force of blood pushing against artery walls during a heartbeat -- was higher than normal among younger women and increased with age.

Average systolic blood pressure among those aged 20 to 39 was 122 mm Hg, while 120 mm Hg is considered normal by the American College of Cardiology and American Heart Association. Middle-aged and older women had an average systolic blood pressure of nearly 133 and 142, respectively.

Obesity and high blood pressure are major risk factors for heart disease, and both are affected by lifestyle factors such as diet and exercise.

Nearly one-third of women aged 20 to 39 said they ate fast food at least three times a week, and 2 of 5 had a higher-than-recommended daily salt intake.

Those rates were also high in middle-aged women but lower among those over 60, according to the study to be presented May 16 at the American College of Cardiology (ACC) virtual annual meeting. Such research is considered preliminary until published in a peer-reviewed journal.

"We're finding obesity and elevated blood pressure are present in women even at younger ages, which is worrisome," Vatsa said in an ACC news release. "Thus, interventions like educating young women about healthy dietary choices and the benefits of exercise, improving access to health care and enhancing the ability for people to adopt healthy practices -- such as increasing access to healthy foods and safe areas for physical activity -- need to start early."

More information

The U.S. Centers for Disease Control and Prevention has more on preventing high blood pressure.

SOURCE: American College of Cardiology, news release, May 5, 2021

Race, Neighborhood Affects How Long You'll Live After Heart Attack

THURSDAY, May 6, 2021 (HealthDay News) -- The risk of dying within five years of a heart attack is notably higher among poor Americans than their wealthier peers, but race also plays a role, a new study reveals.

While Black residents of poor neighborhoods appear to face a higher risk of death than their counterparts in wealthier ZIP codes, poor Black patients are also more likely to die after a heart attack than poor white patients, the researchers found.

For the study, the investigators analyzed neighborhood income and five-year death rates among nearly 32,000 heart attack survivors. All initially received care between 2006 and 2016 within the Kaiser Permanente Southern California hospital system. All had what the study authors characterized as "good health insurance."

The purpose of the study was to evaluate neighborhood income as a possible risk factor for increased death after heart attack, said lead author Dr. Jesse Goitia, a Kaiser cardiology fellow.

Each patient was given "a neighborhood disadvantage score" based on income, employment, education and household data by ZIP code.

Just under two-thirds of the patients lived in relatively wealthier neighborhoods. But more than one-third — about 12,000 patients — lived in disadvantaged areas, ranking in the bottom 75th percentile. In other words, only one-quarter of neighborhoods were poorer.

After a heart attack, Goitia said, patients from the poorer neighborhoods did have higher death rates.

The study found that those in the bottom-ranking ZIP codes faced a 5% higher risk of dying within five years of a heart attack.

"[That finding is] consistent with prior research showing lower socioeconomic status to be a risk for cardiovascular disease," Goitia said.

But, he added, there was a twist.

His team also found that Black patients from disadvantaged neighborhoods had the worst death rates of all racial and ethnic groups.

In other words, while "Black patients from well-resourced neighborhoods had outcomes similar to white patients from well-resourced neighborhoods," being Black and poor was deemed a worst-case scenario, Goitia said.

How much worse?

Black patients from poor neighborhoods faced a 19% greater risk of death within five years of a heart attack compared to richer white patients, the study found. Their risk was also 14% greater than that for poorer white patients.

As to why, Goitia said that, for now, his team's findings raise more questions than concrete conclusions.

"It is likely that patients from worse neighborhoods have risk factors for poor outcomes related to access to open spaces for physical activity, access to healthy foods, difficulty with making it to health care appointments and difficulty filling prescriptions," he said.

But the study does not address precisely why these factors seem to affect poor Black heart attack survivors more than poor white ones.

Dr. Michelle Albert, president of the Dallas-based Association of Black Cardiologists, joined Goitia in calling for more research.

"This study supports previous work indicating that neighborhood adversity is an underlying determinant of health," she said.

But, Albert added, more work is needed to understand how all kinds of factors that are hardwired into the way American society functions may lead to various forms of neighborhood deprivation.

In the meantime, Andrea Roberts, a senior research scientist at Harvard T.H. Chan School of Public Health in Boston, stressed that other studies have provided some important clues.

"From prior research, we know that Black Americans receive worse health care than whites, and we know that stressors like discrimination and poverty are toxic to your heart," said Roberts, who reviewed the findings.

"We also know that some factors that are bad for heart health are more common among Black Americans versus whites. Like obesity, for a variety of reasons," she added. "These include current experiences of discrimination, because stress is a risk factor for obesity, as well as the legacy of discrimination from past generations, which manifests as poverty."

But Roberts cautioned that the new study doesn't appear to address a number of concerns that could influence the findings. For example, the researchers didn't seem to assess the severity of participants' heart attacks.

It's possible that Black patients with mild heart attacks don't end up at the hospital, Roberts said, and the ones who go to the hospital had severe attacks — explaining why their death rates are higher.

Or, she said, it might be that "Blacks have more [heart attacks] in general for whatever reason, or the more severe [heart attacks] kill them immediately, so they don't end up at the hospital."

All of that means that, on its own, the new research can't definitively speak to how much neighborhood deprivation interacts with race to increase the risk for post-heart attack death among Black patients, Roberts said.

Goitia and his colleagues are scheduled to present their findings May 17 at a virtual meeting of the American College of Cardiology.

Research presented at meetings should be considered preliminary until published in a peer-reviewed journal.

More information

Learn more about race, ethnicity and heart disease at the U.S. Centers for Disease Control and Prevention.

SOURCES: Jesse Goitia, MD, cardiology fellow, Kaiser Permanente Los Angeles Medical Center; Andrea Roberts, PhD, MPH, senior research scientist, Harvard T.H. Chan School of Public Health, Boston; Michelle Albert, MD, MPH, president, Association of Black Cardiologists, Dallas; American College of Cardiology, online meeting, May 17, 2021

Eat Smart: Mediterranean Diet Could Ward Off Dementia

THURSDAY, May 6, 2021 (HealthDay News) -- A diet rich in vegetables, fruits, olive oil and fish -- the so-called Mediterranean diet -- may protect the brain from plaque buildup and shrinkage, a new study suggests.

Researchers in Germany looked at the link between diet and the proteins amyloid and tau, which are a hallmark of Alzheimer's but are also found in the brains of older people without dementia.

"These results contribute to the body of evidence that links eating habits with brain health and cognitive performance in old age," said lead researcher Tommaso Ballarini, a postdoctoral researcher from the German Center for Neurodegenerative Diseases in Bonn.

Eating a Mediterranean-like diet might protect the brain from neurodegeneration and therefore reduce the risk of developing dementia, he said.

"However, further research is needed to validate these findings and to better understand the underlying mechanisms," Ballarini said, since this study could not prove a cause-and-effect relationship.

For the study, he and his colleagues collected data on more than 500 people, of whom more than 300 had a high risk for Alzheimer's disease. The participants reported their diets and took tests of language, memory and executive function. They also underwent brain scans, and more than 200 had spinal fluid samples taken to look for biomarkers of amyloid and tau.

After adjusting for age, sex and education, the researchers found that each point lower on the Mediterranean diet scale was linked to nearly one year more of brain aging, seen in the part of the brain closely tied with Alzheimer's disease.

People who didn't follow a Mediterranean diet had higher levels of markers of amyloid and tau, the researchers found. Also, people who didn't follow a Mediterranean diet scored lower on memory tests than those who did.

"Overall, a closer adherence to a Mediterranean-like diet was associated with a preserved brain volume in regions vulnerable to Alzheimer's disease, fewer abnormal amyloid and tau and better performance on memory tests," Ballarini said.

One limitation of the study is that people self-reported their diet, which could lead to errors in recalling what and how much they ate, the researchers noted.

One U.S. expert said diet is only one aspect in the Alzheimer's picture.

"We continue to see literature revolve around nutrition and diet and what it might mean in later life," said Heather Snyder, vice president for medical and scientific relations at the Alzheimer's Association.

Diet, however, isn't the only lifestyle factor that might lower the risk for Alzheimer's disease, she said.

"I think the data continues to evolve and demonstrate that lifestyle interventions are likely beneficial for reducing cognitive decline," Snyder said.

Other lifestyle components, such as exercise, are also important, she said. It's not clear yet how diet and exercise reduce the risk of Alzheimer's disease.

"I think the key is to really understand what that recipe is, because it's unlikely to be any one thing," Snyder said. "It's more likely going to be a combination and the synergy of those behaviors that is most beneficial."

Snyder noted that these same lifestyle factors help reduce the risk of cardiovascular disease and even some cancers. "But there is the need to tease out how and what might be the most beneficial for each of those," she added.

"When we look at Alzheimer's and cognition and cognitive decline, we have consistently seen diets like the Mediterranean diet are associated with lower risk in later life. What they all have in common is that a balanced diet makes sure your brain has the nutrients that it needs," Snyder said.

"I think what we know is what's good for your heart is good for your brain, so eat a balanced diet," she said. "There's no one right diet, but make sure you get all the nutrients you need, but also get active, get moving and stay engaged."

The report was published online May 5 in the journal Neurology.

More information

For more on Alzheimer's disease and diet, see the Alzheimer's Association.

SOURCES: Tommaso Ballarini, PhD, German Center for Neurodegenerative Diseases, Bonn, Germany; Heather Snyder, PhD, vice president, medical and scientific relations, Alzheimer's Association; Neurology, May 5, 2021, online

When Drug Companies Raise Prices, Patients' Out-of-Pocket Costs Rise, Too

THURSDAY, May 6, 2021 (HealthDay News) -- When prescription drug "list" prices go up, patients often take a hit in the wallet, a new study shows.

Researchers found that while some people are buffered against drug price hikes by their health insurance plan, many are not.

Those in plans that require co-insurance or a deductible for prescriptions typically watch their out-of-pocket expenses rise, according to the study.

Prescription list prices are akin to the sticker price on a car, explained lead researcher Dr. Benjamin Rome, of Brigham and Women's Hospital and Harvard Medical School, in Boston.

In the United States, drug companies can decide where a list price starts and how it increases over time. On average, research shows, those prices have increased by 9% each year over the past decade.

Drug manufacturers have argued that list prices "aren't important," Rome said.

That's because manufacturers often offer "rebates" to health insurance plans and pharmacy benefit managers that bring down a drug's net price.

However, Rome's team found those rebates are not shielding patients in many cases.

"We're shining a light on a problem that results from two forces," Rome said.

Rising list prices are one, he noted. The other is the trend for health insurance plans to add co-insurance and/or deductibles to patients' prescription drug coverage.

Co-insurance is the percentage of a health care cost that a patient must cover. So when a drug price goes up, so will the co-insurance.

A deductible, meanwhile, requires patients to foot their health care bills for a certain amount before their insurance coverage kicks in.

Traditionally, health plans required only flat co-payments for medications. So a decade ago, Rome said, many Americans may have been buffered against rising list prices.

The reality is different now, he noted.

In this study, more than half of patients had plans that required co-insurance and/or a deductible for prescription drugs.

The findings come from a national database including 30 million Americans with employer-sponsored health insurance between 2015 and 2017.

The researchers zeroed in on 79 brand-name drugs, finding that list prices typically increased by about 17% over the two-year period.

Overall, the study found, patients in plans that only required drug co-payments seemed to be "insulated" from those price increases.

That was not true of people in plans with co-insurance and deductibles. Their out-of-pocket expenses typically rose by 15%. (Half saw a greater increase, half a lesser one.) And those increases correlated with rising list prices.

In contrast, there was no correlation between patients' out-of-pocket expenses and the post-rebate net price of medications.

The findings were published online May 4 in JAMA Network Open.

Frederick Isasi is executive director of Families USA, a nonpartisan consumer health care advocacy group. He said, "These rebates happen behind the curtain, and the savings are not being passed on to consumers."

But to Isasi, who was not involved in the study, any solution has to go beyond passing rebates on to patients.

"We're seeing drug price increases that are far beyond inflation," Isasi said. And it's those unfettered and "irrational" hikes that are the root issue, he argued.

Not everyone sees it that way.

"The critical question left unanswered by this report is why insurance companies force patients to pay out-of-pocket costs tied to the full price of medicines, while these same insurance companies receive billions of dollars in manufacturer rebates," Sarah Sutton, a spokesperson for the trade group PhRMA, which represents the pharmaceutical industry, said in a statement.

"Nearly half of every dollar spent on medicines doesn't go to the innovative companies that discovered the medicines, but to middlemen, insurers, the government and other entities. This system is broken, and that's why we put forward solutions to lower what patients pay for prescription medicines, including changes that will ensure savings in the system are shared with patients at the pharmacy," Sutton added.

But Isasi said that while drug companies support such measures, they resist reforms that would cut into their profits.

"Any solution here has to address the fundamental issue of price," he said, noting that high drug prices also "get baked into" the monthly premiums people pay for insurance.

Rome agreed that "exorbitant" drug prices are the core issue. Some proposals by lawmakers include caps on list-price increases and penalties against companies that raise those prices above inflation, he noted.

Isasi said, "We know that a third of Americans have a hard time affording their medications." And that, he added, can lead to skipped doses, cutting pills in half and worsening health.

Rome described the system of price hikes and confidential rebates as "sort of a game."

"I don't want my patients, or any patients, to be caught in the middle," he said.

More information

The American Medical Association has more on prescription drug prices.

SOURCES: Benjamin Rome, MD, researcher, Program on Regulation, Therapeutics, and Law, Brigham and Women's Hospital, and instructor, medicine, Harvard Medical School, Boston; Frederick Isasi, JD, MPH, executive director, Families USA, Washington, D.C.; PhRMA, statement, May 2021; JAMA Network Open, May 4, 2021, online

1 in 4 Heart Attacks Arrive With 'Atypical' Symptoms

THURSDAY, May 6, 2021 (HealthDay News) -- A quarter of heart attack patients have atypical symptoms and are less likely to receive emergency care, Danish research reveals.

These patients are also more likely to die within 30 days than those with chest pain.

Atypical heart attack symptoms include breathing problems, extreme exhaustion and abdominal pain.

"Atypical symptoms were most common among older people, especially women, who called a non-emergency helpline for assistance," said study author Amalie Lykkemark Møller, a doctoral student at Nordsjællands Hospital in Hillerød, Denmark. "This suggests that patients were unaware that their symptoms required urgent attention."

For the study, she and her colleagues analyzed data on heart attack-related calls to a 24-hour medical helpline and an emergency number in Denmark between 2014 and 2018. They were looking for adults 30 and older who were diagnosed with heart attacks within 72 hours of the call.

Of the 8,336 heart attacks they found, a specific primary symptom was recorded for 7,222. Chest pain was the most common (72%).

Twenty-four percent of patients had atypical symptoms, with breathing problems being the most common.

Rates of chest pain were highest among 30- to 59-year-old men who called the emergency number and lowest among women over 79 who called the non-urgent helpline. Atypical symptoms occurred mainly in older patients, especially women who called the helpline.

Among callers with chest pain, 95% were sent help through the emergency number, compared to 62% of those with atypical symptoms.

Seventy-six percent of helpline callers with chest pain were sent a dispatch, compared to 17% of those with atypical symptoms, the analysis found.

It also revealed that 5% of patients with chest pain died within 30 days of calling the emergency number, as did 3% of those who called the non-urgent helpline.

That compared with 23% of emergency callers who had atypical symptoms and 15% of those who called the helpline.

After accounting for factors that could affect the results, including age, sex, education, diabetes, previous heart attack, heart failure and chronic obstructive pulmonary disease, researchers pegged 30-day death rates at 4.3% for patients with chest pain and 15.6% for those with atypical symptoms.

The findings were published May 6 in the European Heart Journal – Acute Cardiovascular Care.

"Taken together, our results show that heart attack patients with chest pain were three times more likely to receive an emergency ambulance than those with other symptoms," Møller said in a journal news release.

"People with atypical symptoms more often called the helpline, which could indicate that their symptoms were milder, or they were not aware of the severity," she said. "Vague symptoms may contribute to health staff misinterpreting them as benign."

More information

The American Heart Association outlines the warning signs of a heart attack.

SOURCE: European Heart Journal – Acute Cardiovascular Care, news release, May 6, 2021

Obesity More Deadly for Men Than Women When COVID Strikes

THURSDAY, May 6, 2021 (HealthDay News) -- It's long been known that obesity is a risk factor for severe COVID-19 in infected people. But new research suggests that the connection may be even stronger for men than women.

Researchers at Montefiore Medical Center in New York City analyzed data from more than 3,500 COVID-19 patients admitted to the hospital between early March and May 1, 2020.

Both moderate (a body mass index [BMI] of 35 to 40) and severe obesity (BMI over 40) were tied to higher rates of death for those hospitalized with COVID-19. Compared to patients at healthier weights (BMI 18 to 25), moderately obese COVID-19 patients were 44% more likely to die while in the hospital, and those who were severely obese were nearly twice as likely to die, the research showed.

But gender seemed to matter: The odds for severe pneumonia, need for a ventilator to help with breathing, and death all rose for men who were either moderately or severely obese, but in women those risks rose only for the severely obese.

The study was published May 6 in the European Journal of Clinical Microbiology & Infectious Diseases.

The researchers also looked at why obesity might worsen outcomes with COVID-19.

One theory has been an obesity-linked uptick in systemic inflammation throughout the body. So the study authors investigated if systemic inflammation — assessed by measuring blood levels of the cytokine interleukin 6 (IL-6) — was associated with obesity and higher risks of poor outcomes in COVID-19 patients.

"It is known that a major cause of disease severity and death is an excessive inflammatory response to SARS-CoV-2 that is associated with high levels of circulating cytokines, such as IL-6," study lead author Arcelia Guerson-Gil, of Montefiore Medical Center, said in a journal news release.

"Obesity is considered a state of enhanced chronic inflammation, so we suspected there may be an association between body mass index and systemic inflammation as indicated by IL-6 level," she said. "However, we found that this wasn't the case."

Patients who died did have higher average levels of IL-6 than survivors, men had higher average levels of IL-6 than women, and average IL-6 levels increased with age, according to the study.

But the authors found no clear association between IL-6 and obesity, which they said suggests that while inflammation may play a role in severe disease and death from COVID-19, it may not be the reason for the link between severe disease, death and obesity.

The researchers suggested other ways that obesity may increase the risk of worse outcomes in COVID-19 patients, including reduced lung function, increased effort to breathe, or higher expression in fat tissue of the ACE2 receptor, which allows SARS-CoV-2 (the virus that causes COVID-19) to enter cells.

Impaired breathing could be a possible factor, according to Dr. David Chun, who directs hospital medicine at Glen Cove Hospital in Glen Cove, N.Y.

"The study suggests that different patterns of fat distribution in men versus women could account for the increased death in men," said Chun, who wasn't involved in the research. "In other words, overweight men carry most of their fat in their abdominal region, [and that] has a detrimental effect on lung function, which is more prominent when fighting serious lung infections like COVID-19 pneumonia."

Further research is needed to confirm this study's findings, and clinical trials to assess whether drugs that target fat tissue in the abdomen and chest would improve outcomes in obese COVID-19 patients might prove useful, the study authors concluded.

More information

The U.S. Centers for Disease Control and Prevention has more on obesity and other health conditions that increase the risk of severe COVID-19.

SOURCES: David C. Chun, MD, director of hospital medicine, Glen Cove Hospital, Glen Cove, N.Y.; European Journal of Clinical Microbiology & Infectious Diseases, news release, May 6, 2021

AHA News: Prenatal Stress Can Program a Child's Brain for Later Health Issues

THURSDAY, May 6, 2021 (American Heart Association News) -- Soaring blood pressure. A racing heartbeat. Trouble sleeping. Excessive worrying. Difficulty concentrating. These are warning signs of out-of-control stress and anxiety, and their roots could begin long before you might think.

Anxiety disorders are the most common mental health issue in the United States, affecting nearly 1 in 5 adults, or 40 million people. Another 19 million adults – 8% of the population – has depression. Both can harm heart and brain health.

While the causes of these disorders are not fully understood, researchers believe at least some of the architecture of mental health begins long before adulthood. And a growing number of studies show it can begin in the womb. High levels of maternal stress during pregnancy can predispose a developing fetus to psychiatric and cardiovascular illnesses decades later.

"Prenatal stress does not cause these disorders, it creates a vulnerability to them," said Jill Goldstein, a professor of psychiatry and medicine at Harvard Medical School. She also is founder and executive director of the Innovation Center on Sex Differences in Medicine at Massachusetts General Hospital in Boston.

The stress hormone cortisol plays a vital role in the body and in fetal development. But when a woman is exposed to intense or prolonged stress during pregnancy, excessive levels of cortisol can disrupt development of the unborn child's brain. These changes in fetal brain circuitry can lead to hypersensitivity to stress later in life, Goldstein said, as well as immune system problems that can lay the groundwork for future vulnerability to disease.

She recently published a study in Proceedings of the National Academy of Sciences showing middle-aged people who had been exposed in utero to abnormal levels of pro-inflammatory markers because of stress had poor stress regulation up to 45 years later. Her team's earlier work showed prenatal stress affects the unborn child's later risk for depression, psychosis and heart disease.

But experts caution that not all maternal stress leads to brain changes, and not all pregnant women respond to stress the same way.

"It's not the cause of the stress, but how the person handles it that matters," said Catherine Monk, professor of medical psychology and director of Women's Mental Health @Ob/Gyn at Columbia University Irving Medical Center in New York City.

While some stress is good because it helps people make deadlines or face challenges, poorly regulated or chronic stress is what's potentially harmful.

"If mom is anxious in pregnancy, the fetus could be exposed to greater levels of cortisol. That can subtly change the setpoints for the child's future response to stress," Monk said. But that's not always a bad thing.

During prenatal development, the mother's experience cues the child for what the future may hold, Monk said. If the child is born into an environment rife with threats, being conditioned to respond to a high level of stress is a good thing. They "will be more adept at handling a threatening environment, which might be beneficial to survival."

The problem occurs when there's a mismatch between the way the child's brain has been conditioned and the environment into which that child is born, she said.

A child predisposed to react to high levels of stress but born into an environment that is safe and non-threatening may struggle with anxiety problems, Monk said, because "that level of vigilance and reactivity is not needed."

But it's also important for women to know changes to the baby's brain created during pregnancy aren't irreversible.

"Brain development is fastest in utero, but a remarkable amount also occurs in the first three years of life," said Monk. "There are lots of opportunities to address this."

For example, adults who attend to a child's needs after birth and act as calming forces and role models also will affect a child's brain development, she said.

Even if hyper-reactivity to stress persists past childhood, adults can learn to regulate their stress response.

Mindfulness, cognitive behavioral therapy, insight-oriented therapy and other practices can help adults – including pregnant women – lower stress and anxiety, as can medications.

Monk's research found social support was one of the most important factors in helping women reduce stress during pregnancy. People who felt connected to friends and family members and who had help with errands, for example, were less stressed than those who did not. "Those who reported feeling stressed did not have people who emotionally had their back and could be there to help with things."

Not everyone has that kind of help. Women living with the chronic stress of poverty or structural racism also face higher risks, Monk said, as well as those with depressive disorders – all factors that can result in barriers to finding social support.

One in 20 women of childbearing age in the U.S. and about 13% of pregnant women have depression, according to a 2018 analysis in the journal Obstetrics & Gynecology. Black women are at even greater risk. They are more likely than any other group to report symptoms of stress, anxiety and depression during pregnancy.

Because of the potential long-term health consequences, doctors treating pregnant women should be attentive to their mental as well as physical health, Monk said.

"When you work with a pregnant woman, you have two patients, not just one," she said. "When we're supporting her and her mental health, we're also supporting the future child."

American Heart Association News covers heart and brain health. Not all views expressed in this story reflect the official position of the American Heart Association. Copyright is owned or held by the American Heart Association, Inc., and all rights are reserved. If you have questions or comments about this story, please email editor@heart.org.

By Laura Williamson

Biden Administration to Back Lifting of COVID Vaccine Patents

THURSDAY, May 6, 2021 (HealthDay News) -- The Biden administration announced on Wednesday that it will support a controversial proposal to waive patent protections for coronavirus vaccines, while the drug industry warned such a move would actually dampen the development of vaccines.

The United States had been a holdout at the World Trade Organization over the proposal, which could give drugmakers around the world a look at the trade secrets of how the viable COVID-19 vaccines have been made, The New York Times reported. But President Joe Biden has come under pressure to throw his support behind the proposal, the newspaper reported.

Katherine Tai, the United States trade representative, announced the administration's support for the proposal on Wednesday afternoon.

"This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures," she said in a statement. "The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines."

Tai said the United States would participate in negotiations over the matter, but that those talks would "take time, given the consensus-based nature of the institution and the complexity of the issues involved."

The announcement is only one step toward a potential international agreement on suspending intellectual property rights, the Times reported. Negotiating an agreement that satisfies all member countries will be challenging, and it is far from clear what would happen if such an agreement was reached, the Times said.

Shortly after the decision was announced, the pharmaceutical industry issued a statement that assailed the extraordinary decision. Stephen Ubl, president and chief executive of the Pharmaceutical Research and Manufacturers of America, called the announcement "an unprecedented step that will undermine our global response to the pandemic and compromise safety."

"This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines," he said, adding that the move would have the effect of "handing over American innovations to countries looking to undermine our leadership in biomedical discovery."

But global health activists praised the administration's decision. It is "a truly historic step, which shows that President Biden is committed to being not just an American leader, but a global one," said Priti Krishtel, an executive director of the Initiative for Medicines, Access & Knowledge.

Still, the activists said a waiver alone would not increase the world's vaccine supply. It must be accompanied by a process known as "tech transfer," in which patent holders supply technical know-how and personnel.

"Handing needy countries a recipe book without the ingredients, safeguards and sizable work force needed will not help people waiting for the vaccine," Dr. Michelle McMurry-Heath, president and chief executive of the Biotechnology Innovation Organization, told the Times. "Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new COVID variants."

Craig Garthwaite, a professor of strategy at the Kellogg School of Management at Northwestern University, also noted that, unlike many drugs, the coronavirus vaccines are complex technologies that will be difficult to copy without the help of the companies that developed them.

"People think you're going to pick up this patent and read it like a cheesecake recipe, and make this awesome cheesecake," he told the Times. "You really want Moderna and Pfizer helping you."

Biden sets new goal as vaccination rates drop

As coronavirus vaccination rates start to slow in the United States, President Joe Biden on Tuesday set a new goal to deliver at least one shot to 70% of adult Americans by July 4 while he tries to convince the hesitant to get inoculated.

Some states are leaving more than half of their available doses unordered, so Biden also announced that his administration will now shift doses from states with less need to states with greater demand for shots, the Associated Press reported. He also called for states to make vaccines available on a walk-in basis, and he will tell pharmacies to do the same.

"You do need to get vaccinated," Biden said from the White House Tuesday. "Even if your chance of getting seriously ill is low, why take the risk? It could save your life or the lives of somebody you love."

Dr. Eric Topol, a professor of molecular medicine at Scripps Research in California, told The New York Times he was "overjoyed" by the announcement. He had pushed for loosening vaccine allocation limits last month, when Michigan was struggling with a virus surge and could not get desperately needed extra vaccine doses.

The federal government's new flexibility will allow for states to respond rapidly when they see "the temperatures rising on the heat map of the country," Topol told the Times.

So far, more than 107 million Americans are fully vaccinated, according to the U.S. Centers for Disease Control and Prevention. The United States is now administering first doses at a rate of about 965,000 per day — half the rate of three weeks ago, but almost twice as fast as needed to meet Biden's new target, the AP reported.

"I'd like to get it to 100%, but I think realistically we can get to that place between now and July Fourth," Biden said of his new goal.

His administration will target three areas as it tries to hasten the pace of vaccinations:

  • Adults who need more convincing to take the vaccine.
  • Those who have struggled or are in no hurry to obtain a shot.
  • Adolescents aged 12-15, once federal authorities approve vaccination for that age group.

Ahead of the U.S. Food and Drug Administration's expected authorization of the Pfizer vaccine for kids aged 12 to 15, the White House is also developing plans to speed vaccinations for that age group. Biden urged states to administer at least one dose to their adolescents by July 4 and to deliver doses to pediatricians' offices and other trusted locations, with the aim of getting many young people fully vaccinated by the start of the next school year, the AP reported.

Though White House officials privately acknowledge the steep challenge, Biden sounded an optimistic note on Tuesday.

"The light at the end of the tunnel is actually growing brighter and brighter," Biden said.

FDA set to approve Pfizer vaccine for 12 and older

The FDA plans to expand emergency use of Pfizer's coronavirus vaccine by next week so that children as young as 12 can be immunized.

After Pfizer's trial in adolescents showed its vaccine worked as well in teens as it does in adults, the FDA started preparing to add an amendment covering that age group to the vaccine's emergency use authorization, the Times reported. Federal officials familiar with the agency's plans who were not authorized to speak publicly relayed the information, the Times said.

Medical experts welcomed the news, calling it a major step forward in the U.S. vaccination campaign.

Vaccinating children is key to raising the level of immunity in the population, experts told the Times, and it could put school administrators, teachers and parents at ease if millions of students become eligible for vaccinations before schools open in September.

Dr. Ashish Jha, dean of the Brown University School of Public Health and the father of two teenage daughters, said the approval would be a big moment for families like his.

"It just ends all concerns about being able to have a pretty normal fall for high schoolers," he told the Times. "It's great for them, it's great for schools, for families who have kids in this age range."

Still, with demand for vaccines falling among adult Americans -- and much of the world clamoring for the surplus of American-made vaccines -- some experts said the United States should donate excess shots to India and other countries that have had severe outbreaks.

"From an ethical perspective, we should not be prioritizing people like them [adolescents] over people in countries like India," Dr. Rupali Limaye, a Johns Hopkins University researcher who studies vaccine use, told the Times.

But Jha said that the United States now has enough vaccine supply to both give shots to young Americans and to help the rest of the world. More than 107 million adults in the United States have been fully vaccinated, but at least 44 percent of American adults still have not yet received even one shot.

While most adolescents seem to be spared from severe COVID-19, Dr. Anthony Fauci, the Biden administration's top COVID-19 adviser, has stressed the importance of expanding vaccination efforts to include them and even younger children.

As of Thursday, the U.S. coronavirus case count passed 32.5 million, while the death toll topped 579,000, according to a tally from Johns Hopkins University. Worldwide, over 155.3 million cases had been reported by Thursday, with more than 3.2 million people dead from COVID-19.

More information

The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.


SOURCES: Associated Press; The New York Times

Health Highlights: May 6, 2021


CDC Gives Cruise Ship Lines Guidelines for Simulated Voyages

Guidelines for cruise ship lines to conduct simulated voyages as a step toward resuming sailing in American waters were issued Tuesday by the U.S. Centers for Disease Control and Prevention.

The guidelines outline all the requirements and recommendations for cruise ship operators to begin simulated voyages with volunteer passengers before they can restart restricted passenger services, the CDC said.

The document outlines how CDC inspections of cruise ships will be conducted during simulated and restricted passenger voyages, and includes requirements and recommendations on COVID-19 prevention and surveillance on ships.

"CDC is committed to working with the cruise industry and seaport partners to resume cruising following the phased approach outlined in the [guidelines]," the agency said in a statement. "This goal aligns with the prospective resumption of passenger operations in the United States by mid-summer, expressed by many major cruise ship operators and travelers."

"COVID-19 vaccines play a critical role in the safe resumption of passenger operations, but not all cruise ship operators have announced plans to mandate passenger vaccinations," the agency added. "As more people are fully vaccinated and more drug therapeutics are available, the phased approach allowed CDC to incorporate these advancements into planning for safe resumption of cruise ship travel. CDC recommends that all port personnel and travelers [passengers and crew] get a COVID-19 vaccine when a vaccine is available to them."

Cruise ship sailings in U.S. waters were halted last year by the CDC in response to the coronavirus pandemic.


Woman Gives Birth to Nine Babies

A Malian woman who had been expecting seven babies gave birth to nine instead, and the mother, five girls and four boys "are all doing well," Mali's health minister said Tuesday.

The babies were born by cesarean section on Tuesday in Morocco, where their 25-year-old mother, Halima Cisse, had been sent for special care, the Associated Press reported.

The nonuplets are in incubators in the private Ain Borja clinic in Casablanca.

The case appears to be the first on record of a woman giving birth to nine surviving babies at once, the AP reported.

Cisse gave birth prematurely at 30 weeks and is now in stable condition after heavy bleeding for which she was given a blood transfusion, the AP reported.

The Guinness Book of World Records told the AP on Wednesday that its current record for most living births at once is eight, and that it is verifying the Morocco births.


Pfizer to Seek Approval in Fall for COVID Vaccine Use in Children Aged 2-11

Emergency use authorization for Pfizer's COVID-19 vaccine to be given to children ages 2 to 11 could be sought from the U.S. Food and Drug Administration by September, the company said Tuesday.

During a quarterly earning call with Wall Street analysts and reporters on Tuesday, Pfizer also said it plans to apply to the FDA this month for full approval of the vaccine for use in people ages 16-85, The New York Times reported.

Obtaining full FDA approval would allow the companies to market the vaccine directly to consumers. The approval process is expected to take months, the Times said.

It may also make it easier for companies, government agencies, schools and other entities to require vaccination. The University of California and California State University school systems, for instance, have announced that once coronavirus vaccines receive full FDA approval, they will require students, faculty and staff members to be vaccinated, the Times reported. The U.S. military, which has seen many troops decline coronavirus vaccines, has said that it would not make them mandatory as long as the vaccines have only emergency authorization.

Pfizer's announcement came as the pace of vaccination in the United States has been slowing.

"We are essentially nearing the end of vaccinating those that were willingly waiting to get in line to get it," Rupali Limaye, a public health researcher at Johns Hopkins who studies vaccine use, told the Times. "And so, the next push is going to be I think more critical than ever."

Full approval from the FDA could help boost confidence in the vaccine, especially among people who may have lingering worries about how quickly it was developed, Limaye said. "I think people still have concerns about it even if they know that no corners were cut," she said. "It will nudge people to say, 'OK, it's been thoroughly vetted.'"

Pfizer also said clinical trial data on the safety of the vaccine in pregnant women is expected by early August.

FDA emergency use authorization for the vaccine's use in children aged 12-15 is expected by early next week, the Times reported.

Real-World Studies Show Pfizer Vaccine Shields Against COVID Variants

THURSDAY, May 6, 2021 (HealthDay News) -- In two real-world studies, Pfizer's COVID-19 vaccine appears to be standing up well against the challenges posed by more contagious coronavirus variants from Britain and South Africa.

The Pfizer mRNA vaccine showed about 90% documented effectiveness in protecting against infection with the British B.1.1.7 variant and 75% effectiveness against the South African B.1.351 variant, according to numbers out of Qatar, a small Arabian nation located on the Persian Gulf.

The vaccine "was effective against infection and disease in the population of Qatar, despite the B.1.1.7 and B.1.351 variants being predominant within the country," reported researchers from Weill Cornell Medicine-Qatar in Doha, Qatar.

The effectiveness against the variants was lower than the 95% efficacy demonstrated in clinical trial data for which the Pfizer vaccine received emergency use authorization from the U.S. Food and Drug Administration, according to the team led by Laith Abu-Raddad.

"Nevertheless, the reduced protection against infection with the B.1.351 variant did not seem to translate into poor protection against the most severe forms of infection [i.e., those resulting in hospitalization or death], which was robust, at greater than 90%," the Qatar researchers wrote. Their report was published May 5 in the New England Journal of Medicine.

Meanwhile, a second study published the same day in The Lancet medical journal showed that two doses of the Pfizer COVID-19 vaccine provide a high level of protection.

The findings from Israel -- the first nation to report national data on the vaccine -- showed that two doses provide more than 95% protection for people age 16 and older against COVID-19 infection, hospitalization and death.

The study period was from Jan. 24 to April 3, 2021, a time when the dominant strain in Israel was the B.1.1.7 variant first detected in the United Kingdom.

Pfizer vaccine holds its own against variants

A single dose of the vaccine provided 58% protection against infection, 76% against hospitalization and 77% against death, the investigators found.

The differences between the effectiveness of one or two doses highlights the importance of fully vaccinating adults, the researchers said.

The findings also show the public health benefits of a national vaccination program, which was the key driver of a decline in COVID-19 infections in Israel.

"As the country with the highest proportion of its population vaccinated against COVID-19, Israel provides a unique real-world opportunity to determine the effectiveness of the vaccine and to observe wider effects of the vaccination program on public health," said study author Sharon Alroy-Preis, from the Israel Ministry of Health.

"Until this point, no country in the world had described the national public health impact of a nationwide COVID-19 vaccination campaign," she noted in a journal news release. "These insights are hugely important because, while there are still some considerable challenges to overcome, they offer real hope that COVID-19 vaccination will eventually enable us to control the pandemic."

One U.S. expert called the Qatar data "very good news."

"This is another example of the vaccine's value at being protective against COVID-19 infection, even when variant strains are involved," said Dr. David Hirschwerk, attending infectious diseases physician at Northwell Health in Manhasset, N.Y.

By comparison, the estimated effectiveness of the annual flu vaccine usually ranges between 40% and 60%, with some years dipping even lower, according to the U.S. Centers for Disease Control and Prevention.

Breakthrough infections after vaccination were rare

That's because the influenza virus mutates much more readily than the COVID-19 virus, and each year's flu vaccine constitutes an educated guess about which new strains will circulate most widely in the United States.

In the study, genetic testing indicated that about 50% of COVID-19 cases in Qatar between Feb. 23 and March 18 were caused by the South African variant and 45% by the British variant.

As of March 31, breakthrough infections had been recorded in 6,689 Qatar residents who had received one dose of the vaccine, and in 1,616 people who had received two doses.

That's out of the nearly 386,000 people who'd gotten one dose and the more than 265,000 who'd completed the two-dose vaccination series.

Seven deaths from COVID-19 have been recorded among vaccinated persons in Qatar -- five after the first dose and two after the second.

"The study illustrates what many of us have been highlighting for some time: that when it comes to serious disease, hospitalization and death, the major vaccines fare extremely well even in the face of problematic variants like B.1.351," said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore.

"While virus variants may be able to escape some immunity induced by vaccines, the vaccines are still highly effective at the task they were designed for: taming the virus and removing its ability to kill," Adalja concluded.

Dr. Miriam Smith is chief of infectious diseases at Long Island Jewish Forest Hills in New York City. Reviewing the Qatar findings, she said that "despite a reduction in protection against infection with the B.1.351 variant, the vaccine is effective and should absolutely be encouraged."

And the bigger slice of the world's population that gets vaccinated, the better, Smith added.

"Viruses naturally mutate over time," Smith said, but "increased immunity of the population will have a positive impact on reducing viral transmission and the virus' ability to develop additional variants that could potentially cause resistance vaccine."

More information

The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccines.

SOURCES: David Hirschwerk, MD, attending physician, Infectious Diseases, Northwell Health, Manhasset, N.Y.; Miriam Smith, MD, chief, Infectious Diseases, Long Island Jewish Forest Hills, New York City; Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore; New England Journal of Medicine, May 5, 2021; The Lancet, May 5, 2021

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