The company logo sits atop a building on the headquarters campus of Eli Lilly and Company on March 17, 2024 in Indianapolis, Indiana. (Scott Olson/Getty Images)
(NEW YORK) — Pharmaceutical company Eli Lilly issued a warning in an open letter on Thursday about the dangers of fake and compounded versions of its diabetes and weight loss medications Mounjaro and Zepbound.
The company also announced new lawsuits against wellness centers and medical spas advertising these drugs.
Eli Lilly’s main competitor, Novo Nordisk, which sells Ozempic and Wegovy, has also filed lawsuits against med spas purportedly selling knockoff versions.
Both companies say the extraordinary demand for these drugs has led to shortages, which has in turn prompted black and grey market sales of other versions of their products that may pose a health risk to consumers.
In its Thursday open letter, Eli Lilly issued a major warning to consumers, saying the company is “deeply” concerned about the proliferation of online sales of fake versions of its products, and that people should never put products labeled “research purposes only” or “not for human consumption” into their bodies.
Eli Lilly says they never sell genuine Mounjaro or Zepbound on social media.
Fake drugs aside, Eli Lilly is also raising concerns about compounding pharmacies. These are technically legal amid an ongoing drug shortage, but the Food and Drug Administration has raised concerns about bad actors making substandard products.
Eli Lilly says that the company has done testing of compounded versions of their drug, and they have observed safety, sterility and efficacy problems. Some of the products have bacteria, high impurities, different colors or a completely different chemical structure than the company’s FDA-approved medicine. In at least one instance, the product was nothing more than sugar alcohol, Eli Lilly said.
In addition to these warnings about fake and compounded products, Lilly reiterated the company’s prior stance that these drugs should not be prescribed or used for “cosmetic” weight loss. The company said they should be for people living with diabetes and/or obesity, or who are overweight with other related medical conditions.
(NEW YORK) — This year, the American Society of Clinical Oncology — the world’s leading oncology organization — recommended palliative care for everyone with advanced cancer at the time of diagnosis and while receiving treatment.
Palliative care clinicians manage cancer-related symptoms and side effects from treatment, while addressing quality of life and stress for patients and families.
By next year, 693,000 people in the United States will have advanced breast, prostate, lung, colorectal, bladder, or skin cancer. Typically, advanced cancers spread to other parts of the body, and may cause symptoms or are difficult to cure.
Oncologists said starting palliative care when a diagnosis is made may make it easier for patients to stay on their treatment course.
“What I’m really excited to see is that these guidelines are taking a step back and thinking about [palliative care] from the time of diagnosis,” Dr. Arif Kamal, chief patient officer for the American Cancer Society and an associate professor at Duke University specializing in oncology and palliative care, told ABC News. “It should particularly be used in areas to help people stay on treatment, such as in clinical trials or hematologic malignancies.”
Here are six things to know about palliative care:
Palliative care can help you live better and longer
“Many people are surprised to hear research shows early palliative care involvement not only improves quality of life but also prolongs survival,” Dr. Allison Chang, an oncologist at the Dana Farber Cancer Institute, told ABC News.
Palliative care puts you in control of your care
Palliative care teams work closely with a patient’s oncologist throughout their cancer journey.
Palliative care supports you and those who matter most
“Palliative care is very deliberate in seeing, recognizing and assessing the needs of caregivers… [who] are such an important part of the clinical team,” said Kamal.
Palliative care increases your time at home or where you want to be
Dr. Anthony Back, a professor of medicine at the University of Washington’s Division of Oncology, told ABC News about a patient with breast cancer whose chemotherapy made her too tired to do things her two young kids needed.
Palliative care helped with her fatigue and worry so she could manage and feel like “mom” again, he said.
Palliative care is covered by most insurance companies
Find a palliative care provider near you.
Palliative care isn’t just for people with cancer
Anyone with a serious illness can get palliative care, and it’s recommended for heart and kidney failure.
Kamal recommends asking your doctor “Could the extra support of a palliative care team be helpful to me?” He finds asking is often enough for doctors to make a referral.
Palliative care is no longer something that’s “nice to have. It’s a have to have,” said Kamal.
Lindsey Ulin, MD is an internal medicine resident at Brigham and Women’s Hospital and a member of the ABC News Medical Unit.
(NEW YORK) — As the United States heads into the summer season, early indicators show the country is likely to experience an increase in COVID-19 infections.
For the week ending June 8, the latest date for which data is available, COVID test positivity was 5.4% across the U.S., an increase of 0.8% from the previous week, according to data from the Centers for Disease Control and Prevention (CDC).
In the Western region — which is comprised of Arizona, California, Hawaii and Nevada — COVID test positivity was 12.8%, higher than any other region of the U.S. The New England region — made up of Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont — had the next highest test positivity rate at 5.4%, matching the national rate.
Wastewater data from the CDC shows that although viral activity levels are still low nationally, levels have more than doubled in the western U.S. over the last month.
Additionally, COVID emergency department visits for the week ending June 8 rose 12.6% from the week prior, according to CDC data.
Traditionally, the U.S. has seen increases in COVID every summer, typically after the Fourth of July, but public health experts said Americans will likely see a “drift upwards” rather than a surge.
“To put it proportionally to like where we were in many winters, we are at a very, very low rate of COVID, compared to some of our peaks,” Dr. Cameron Wolfe, a professor of medicine in the infectious diseases division at Duke University, told ABC News. “Like compared to early 2022, for example, when omicron first emerged, this is night and day different. But … there’s just this little drift upwards, perhaps in the last few weeks.”
Increases have been seen in several states, most notably on the West Coast. In Los Angeles, the county’s Department of Public Health reported an average of 121 cases on June 13, up from a daily average of 106 instances one week prior.
However, experts said a combination of us learning how to better manage the virus and having high levels of immunity means COVID will not be a major threat to the average person.
“Our bodies have learned how to manage the virus over the last four years, meaning that many people have had successive waves of infection, many people have had initial vaccinations,” Dr. Peter Chin-Hong, a professor of medicine and infectious disease specialist at the University of California, San Francisco, told ABC News. “So that combined immunity gives a big force field that can help protect us during the summer. … Although most people will be fine, there are still some people that are going to get very sick.”
As of Tuesday, hospitalizations and deaths in the U.S. remain stable. For the week ending May 18, the last week of complete data, there were 311 deaths due to COVID, which is the lowest death figure recorded in the U.S. since the beginning of the pandemic.
Chin-Hong said most hospitalizations and deaths are occurring among high-risk groups, including elderly individuals aged 75 and older and people who are immunocompromised, such as those who have undergone organ transplants or are on medications that suppress the immune system.
He recommends the average person track COVID wastewater data from the CDC to see if it’s trending upwards in their area and to keep masks and COVID rapid tests handy in case they need them, but he added that an increase in COVID should not be cause for fear.
“I think there’s a fine balance between ignoring everything and being scared by everything,” Chin-Hong said. “It’s like when you’re crossing the street. You never just run across a busy road; you always look both ways, but it doesn’t mean you don’t go to the next destination. So, I think in the new… phase of COVID, that’s the way we should think about it.”
Similarly, Wolfe said people should assess their individual risk and take more precautions if they will be around high-risk individuals such as senior citizens or sick patients. He also recommended getting the newest updated COVID vaccine that will likely be rolled out in late September.
“Very much in the same way that flu vaccines are tailored each year to adapt to the strains that we see, the same is occurring with COVID,” Wolfe said. “And I think for someone who might be themselves or someone in their family or close contact known to be high risk I’m going to be still actively encouraging those people to get vaccinated.”
(GREENWICH, Conn.) — For years, Jose Dominguez, 50, had wanted to donate blood, feeling it was part of his civic duty.
But he was restricted by rules set in place by the U.S. Food and Drug Administration that did not allow sexually active gay men from donating.
That finally changed in May 2023, when the FDA dropped all restrictions specific to gay and bisexual men donating blood, moving to a new blood donation risk assessment tool that is the same for every donor regardless of how they identify, which rolled out in August 2023.
In March of this year, Dominguez finally donated blood for the first time, and he did so with his husband, Craig Burdett. For Burdett, 62, it was the first time he had donated blood since 1997, when he began openly identifying as gay.
“I was grinning just from ear to ear, just because of the fact that we were able to do this,” Dominguez, who is the head of the American Red Cross Long Island chapter, told ABC News. “I’ve never done it before, and I was getting to do it with my husband.”
“This is something that we had talked about along during our relationship and anytime somebody said they donated blood, I’m like, ‘That is such a privilege. It is such a privilege to be able to do that and one day, we will,'” he continued. “But it was just like, ‘Whoa, this is so cool. It’s finally happening.'”
So, did the rule change bring in more donors? Blood donation organizations say although it’s a bit too soon to tell, early data seems to indicate it did make a difference.
New policy allowing gay and bisexual men to donate In the early days of the HIV/AIDS epidemic, blood donations were not able to screen for HIV, which led to some cases of HIV via transfusion. This led to the FDA instituting a lifetime ban on gay and bisexual men from donating blood as well as women who have sex with men who have sex with men.
In 2015, the blanket ban was repealed, but the FDA placed restrictions on men who have sex with men, saying they could donate if they were abstinent from sex for at least one year. In 2020, this was shortened to a period of 90 days of abstinence.
In 2023, the FDA announced it would no longer be issuing blanket bans due to sexual orientation and instead screen potential donors on their risk of contracting and transmitting HIV, with the policy going into effect in August.
At the time, the federal health agency said it would use “gender-inclusive, individual risk-based questions” without compromising “the safety or availability of the blood supply.”
Questionnaires ask all donors about new or multiple sexual partners in the past three months. Those who have had a new sexual partner or multiple partners in the past three months and a history of anal sex during that time period will be deferred. Those taking medications to treat or prevent HIV infection will also be deferred, but LGBTQ+ advocacy groups say the new FDA rules are an important step in the right direction. The new blood donation risk assessment is the same for every donor regardless of how they identify.
‘I’m being ostracized’ Burdett, who runs a freelance web design business, grew up with a mother who was a regular blood donor due to a rare blood type, though he can’t remember what type exactly. He said she would get calls in the middle of the night to donate and, when she did, she would take him and his younger brother along with her.
“She taught us that giving blood was an important part of being part of the community,” he said. “You give blood because that’s an easy way to give back and to support your community. And so, I grew up giving blood every eight to 10 weeks, whenever I remembered that it was time, I gave blood until I came out as a gay man in the mid-90s.”
The last time Burdett donated blood was in 1997. At the time, the FDA still had a lifetime ban for blood donations from gay and bisexual men.
Not being able to do so because of sexual orientation made him feel excluded from a community he’d been part of for so many years.
“When I couldn’t give blood again, I felt like I was being pushed out the community,” Burdett said. “It felt like I lost something.”
Dominguez said that growing up, he had many family members in hospitals due to health problems. When he would visit, he would see people donating blood, but he knew he couldn’t, and it made him feel “ostracized.” Dominguez said he never attempted to donate.
“Of course, there were regulations, FDA regulations that were set in place,” he said. “But I remember in college, when I finally was able to do it, and being a gay male, I couldn’t because of the restrictions…I’m thinking, ‘Oh, my God, I’m being ostracized.'”
When the couple first heard during the COVID-19 pandemic that the FDA was considering rolling out a new policy that did away with most deferrals, Dominguez was optimistic, but Burdett was doubtful.
“I raised a skeptical eyebrow, like that’s not gonna happen,” Burdett said. “They’re gonna have some rule like you can’t have had sex for six months. … So when it was that we really [could give] blood, I was really surprised — surprised and super happy.”
People returning after being deferred Blood donation organizations said early data indicates that the policy has made a difference — bringing back donors who were previously unable to give blood.
Since the American Red Cross implemented the FDA’s individual donor assessment last summer, about 8.5% of more than 2,000 people with the most recent three-month deferral on their donor record returned to donate in the first five months after the policy change, the organization told ABC News.
Local organizations report similar results. New York Blood Center (NYBC) said between 240 and 250 people deferred under the 90-day policy have since returned to donate blood.
Andrea Cefarelli, senior vice president for NYBC, told ABC News it’s been less than a year since the new policy and people are still learning they are now eligible to donate, so that number should increase.
“What we would never know is someone that … knew from friends or from media coverage that they were not eligible and then comes in and donates. We wouldn’t have that figure that [they] sort of self-deferred before,” she said. “So, is it making an impact? I’m sure that it is.”
OneBlood — which has service areas in Florida, Georgia, North Carolina, South Carolina — told ABC News that of 7,092 people who deferred under the previous one-year and three-month deferral periods, 902 returned to donate under the new policy over the last 10 months, equating to 1,334 donations.
While there are people like Dominguez and Burdett who donated blood after becoming eligible under the new donor assessment, they acknowledged some gay and bisexual men may still be angry that they were prevented from donating blood previously, even if they were practicing safe sex at the time.
“There were a lot of hurt feelings in the gay community about when gay men were banned from giving blood,” Burdett said. ‘There’s still a group of gay men about my age who hold a lot of animosity about it.”
“I understand the panic in the early 80s…But there are a lot of folks who are not ready to forgive and forget. As we meet them, and talk to them, encourage them to give blood because it’s part of being a community and…you’re giving to your neighbor,” he added.
Burdett and Dominguez say they plan to donate again as soon as possible and want to encourage conversations with other members of the LGBTQ+ community to consider donating if they haven’t already.
“I think we’re in the perfect month to start this conversation,” Burdett said of Pride Month. “There are a lot of Pride parades going on. So, I would encourage anyone who accepts blood to be present and be at those events and to do the education and let people know, pamphlets, flyers, tell them folks that gay men can give blood, and I would suspect that would be helpful.”
(NEW YORK) — Creating a surgeon general’s warning for social media is a necessary step to respond to the “defining public health challenge of our time,” U.S. Surgeon General Vivek Murthy told ABC News’ Elizabeth Schulze in an interview on Monday.
“We are living in the middle of a youth mental health crisis, and I have said publicly that this is the defining public health challenge of our time. I firmly believe that. And social media has emerged as an important contributor to that youth mental health crisis, so making social media safer for our kids — warning kids and parents about the harms associated with social media — is urgent,” Murthy said.
“It’s part of addressing the broader mental health crisis that we’re living through,” he said.
The warning, which would appear universally in social media feeds to raise awareness about the risks of social media on adolescent mental health, would need congressional action to be implemented. Testing on the best messaging and frequency of the warnings would then be conducted, Murthy said, with the goal of “driving toward behavior change.”
“I was getting questions from parents all across the country about social media, and they wanted to know, is this safe for my kids? And what we can conclude, based on our research and talking to experts from around the country, was that social media, number one, has not been proven to be safe for kids. And number two, there is mounting evidence of harms associated with social media use,” Murthy told Schulze.
“So, we want to make sure that parents and kids know that. And that’s where a warning label comes into play.”
The issue is also urgent because 95% of adolescents are on social media, Murthy said, echoing the case he made in a New York Times op-ed.
“The data tells us that kids who spend an average of three hours or more on social media a day, they experience a doubling of their risk for anxiety and depression symptoms. That’s pretty profound, but also particularly disturbing when you keep in mind that the average amount of use for adolescents today is 4.8 hours a day,” he said.
When tobacco warnings were implemented in the U.S. in 1966, 42% of Americans smoked, Murthy said. Today, that’s down to 12%. However, that change took nearly six decades and was only one step in a larger effort of education and reform.
“While we are late as a society to ultimately making these platforms safer, it’s urgent that we start taking action now. Because the truth is, there’s nothing more important to the mental health and well-being of our kids,” Murthy said.
“I say that not just as surgeon general and as a doctor, but as a father to of two young kids who I’m worried about, just like millions of parents are worried about the mental health and well-being of their children,” Murthy said.
Murthy said his kids aren’t allowed to use social media until they graduate from middle school, at which point he and his wife will review the data around safety and whether any platform regulations have been implemented, as well as the ability of his kids to safely navigate it.
For kids who are already on social media, the goal should be creating phone-free zones, he said, like dinner time, social interactions and bedtime. He encouraged parents to build communities around phone-free zones, because it’s “much easier to do when we are doing them collectively as a group of parents.”
Murthy acknowledged that on a larger scale, the ball is in Congress’ court — both in implementing warnings, and in providing broader safeguards against social media risks to mental health. Particularly in a tense election year where legislative gridlock is the norm, that poses a problem.
“But as a nation, we can do hard things when it comes to protecting and safeguarding our kids. We should be ready to do everything possible to achieve that end,” Murthy contended.
In the meantime, Murthy is committed to raising awareness in hopes that parents and kids will begin limiting screen time.
“The bottom line is, again, making the platform safer is the key. But until then, until that actually happens, it’s important that we make sure parents and kids know what we now know in medicine and public health, which is this association between social media use and mental health harms.”
(NEW YORK) — Rates of high blood pressure during pregnancy doubled between 2008-2021, but only 60% were treated for it, according to a new study published Monday in the journal Hypertension.
“One of the main drivers of adverse outcomes during pregnancy is due to high blood pressure,” Stephanie Leonard, an Assistant Professor of Obstetrics and Gynecology- Maternal Fetal Medicine at Stanford and lead author on the study, told ABC News.
Chronic hypertension in pregnancy is defined as high blood pressure diagnosed before pregnancy or before 20 weeks of pregnancy.
While it’s not clear why rates have increased so dramatically, prior research suggests it may be because more people are choosing to wait until they are older to have children.
Chronic hypertension can lead to serious complications that can be dangerous for pregnant people and their babies. The U.S. maternal death rate remains the highest among high-income countries, with Black women experiencing the highest rates and they are also disproportionately affected by hypertension in pregnancy.
“Heart disease is the number one cause of death of women in the U.S., and women have unique risk factors as compared to men,” Maria Pabon, a cardiologist at Brigham and Women’s Hospital specializing in women’s cardiovascular health, said in an email to ABC News.
“High blood pressure during pregnancy can increase the risk of different kinds of heart disease in the future,” Pabon said.
But doctors say there are concrete steps people can take to lower their risk.
“Being aware that having a history of high blood pressure during pregnancy can increase your risk of future heart disease,” Pabon said. She encourages lowering other risk factors for developing heart disease by eating a heart-healthy diet, such as the Mediterranean diet, and working on exercise, sleep, and stress management.
Annual screening for heart disease should include checking “blood pressure, weight, and cholesterol. Everyone should have a Lipoprotein A level checked once,” Pabon said.
If you have a family history of heart disease, Pabon recommends seeing a cardiologist specializing in women’s health or prevention cardiology to consider other testing.
Ask your doctor if you should check your blood pressure at home. If you have a blood pressure monitor at home, bring it to your next appointment to check for fit and accuracy.
The American Heart Association has tips for checking your blood pressure at home.
Don’t smoke, drink caffeinated beverages or exercise within 30 minutes before taking your blood pressure.
Don’t take measurements over clothes.
Rest for five minutes before checking and sit still.
Check at the same time every day.
Sit up straight with your back supported and feet flat on the floor. Rest your arm on a flat surface.
Take multiple measurements and record the numbers.
According to the new study, not enough people are getting treatment for their high blood pressure during pregnancy, with the study estimating that only 60% are treated.
Typically, anyone with high blood pressure during pregnancy is treated with medication if blood pressure is above 140/90.
Dr. Justin Brandt, an Associate Professor in the Department of Obstetrics and Gynecology at NYU Grossman School of Medicine and the Division Director of Maternal Fetal Medicine, said 60% may be an underestimate because not all doctors are aware of updated medical consensus about treating hypertension during pregnancy.
In 2022, a major medical group updated its guidance to commend treating people even with mild hypertension during pregnancy – a shift from prior guidance, which said to start medication if blood pressures were above 160/110.
“Our approach really changed. We realized that treatment reduced complications in pregnancy like pre-eclampsia without affecting fetal growth,” Brandt said.
Lindsey Ulin, MD is a resident in internal medicine at Brigham and Women’s Hospital and a member of the ABC News Medical Unit.
(WASHINGTON) — The U.S. surgeon general called on Monday for social media platforms to include health warnings for younger users.
“It is time to require a surgeon general’s warning label on social media platforms, stating that social media is associated with significant mental health harms for adolescents,” Vivek H. Murthy wrote in an op-ed published in The New York Times.
This is a developing story. Please check back for updates.
ABC News’ Ahmad Hemingway contributed to this report.
(MEXICO) — The World Health Organization confirmed Friday that Mexican authorities believe the man with a rare human case of bird flu actually died from other co-morbidities.
On June 5, the WHO shared an update that a 59-year-old patient died with the H5N2 strain of bird flu, or avian influenza. It was the first laboratory-confirmed human case of the H5N2 strain reported globally and the first-ever reported case in Mexico.
This strain is different than the bird flu strain that is currently circulating in livestock in the United States. Three dairy workers have been infected in the U.S., all of whom have recovered.
Following the first release, Mexican Health Secretary Jorge Alcocer Varela pushed back on the WHO’s statement, saying the man died from a separate condition and not bird flu, although the WHO said the patient only tested positive for bird flu, not that he had died of bird flu.
In the latest update, the WHO said health officials in Mexico had concluded the man died because of his co-morbidities.
“A national multidisciplinary group of experts was formed to investigate the cause of death. It included infectious disease specialists, pneumonologists, microbiologists and intensive care professionals,” the WHO wrote. “Upon review of the patient’s clinical history and records, the national multidisciplinary team concluded on 6 June that, although the patient had a laboratory-confirmed infection with avian influenza A(H5N2) virus, he died due to complications of his co-morbidities.”
Additionally, the WHO said national authorities performed a genetic analysis on the strain and found it had a 99% similarity with the strain seen in birds this year in the Texcoco State of Mexico.
The Mexico patient had no history of exposure to poultry or other animals, according to the WHO. Mexico has been dealing with an outbreak of the virus in poultry.
On April 17, the patient developed fever, nausea, diarrhea, shortness of breath and general malaise. He was hospitalized on April 24 at the National Institute of Respiratory Diseases in Mexico City and died the same day.
The patient’s relatives said he had been bedridden for three weeks for other reasons prior to contracting bird flu, the WHO said.
Mexican authorities reported the human case to the WHO on May 23.
No further cases have been documented during health officials’ investigation, according to the WHO. All the people the patient was in contact with at his home and in the hospital have tested negative for influenza viruses.
In the U.S., an outbreak of the H5N1 strain has been found to sicken millions of birds as well as older dairy cows. So far, three farmworkers have been sickened in the U.S., one in Texas and two in Michigan.
All three had mild symptoms and have recovered. There is no evidence of human-to-human transmission and the risk to the general public is low, according to the Centers for Disease Control and Prevention.
(NEW YORK) — Helen Macura has always wanted a dog, but the Prohibition-era home she has lived in since 1945 isn’t safe for a potential pet. Her childhood dream of owning a dog finally came true a couple years ago, when Helen was in her late 90s.
Today, at 101 years old, Helen says she is grateful for her robotic dog that she has affectionately named “Friendly.”
Friendly is battery-powered and resembles a golden retriever puppy. He is one of the 31,500 robotic pets already given away by the New York State Office For Aging (NYSOFA). The pup barks, turns his head and raises his paw. Importantly, he does not run out the door onto her busy street.
On June 3, NYSOFA announced that it will give away 4,725 additional robotic pets to seniors in ongoing efforts to combat senior loneliness. Greg Olsen, the acting director of NYSOFA, said that loneliness has grave health consequences for seniors and it “can literally kill you.” Robotic pets are one tool to help alleviate loneliness.
Critics may argue robotic pets are “botsourcing” — or outsourcing — human connection to robots, but Olsen said robotic pets can be a way to connect with other humans by being a common topic of conversation.
Ted Fischer originally envisioned robotic pets for seniors while working at a children’s toy company. The product was intended for school-aged children but “about 20% of the reviews were not mom buying it for their four-to-eight-year-old daughter, but buying it for an aging loved one,” Fischer said.
Fischer’s convictions about the benefit of robotic pets for seniors led him to launch Ageless Innovation, a company that creates products for people of all ages to play.
Olsen remembers first seeing a robotic pet his daughter bought online in 2018. He immediately thought it would be a fantastic product for “some of our isolated and lonely older adults that are already on our caseload.” Olsen found Fischer online, and a partnership was formed.
Since 2018, NYSOFA has purchased subsidized robotic pets for seniors from Ageless Innovation using state general funds. Pets include not only robotic cats and dogs, but also birds — affectionately termed “walker squakers.” The pets have been popular, and certain counties have even had to create waiting lists for seniors who want the pets.
“I recommend that every home should have one,” said Macura, referencing her robot dog. Some nights when she cannot sleep, she sits in the living room and talks to Friendly.
“I’m talking to somebody. I do have companionship. There’s somebody here listening to me,” she said. “He’s warm and he’s comfort.”
Dr. Julianne Holt-Lunstad, a professor of psychology and neuroscience at Brigham Young University, has researched the health effects of loneliness for the last 25 years. Her research was cited in Surgeon General Vivek Murthy’s 2023 declaration of an “epidemic of loneliness and isolation.”
“The mortality impact of being socially disconnected is similar to that caused by smoking up to 15 cigarettes a day,” the advisory states, a reference to Holt-Lunstad’s work.
She explained, “When we are alone or not part of a group, it takes more effort to either be vigilant to threats in our environment or to just meet the everyday demands of life.”
Holt-Lunstad continued that the stresses of being socially disconnected “can increase activation in our brain.” Over time, increased activation in the brain can signal the bone marrow to create an inflammatory response. Chronic systemic inflammation has been linked to a host of diseases, said Holt-Lunstad.
The surgeon general’s advisory enumerates these outcomes, stating that loneliness “is associated with a greater risk of cardiovascular disease, dementia, stroke, depression, anxiety, and premature death.”
Holt-Lunstad said that loneliness is a biological motive, like hunger and thirst. Loneliness “signals some kind of change that needs to be made,” she said.
The solution to loneliness is social connection. The connection must be consistent and, “in a way, it’s very parallel to physical activity. One time is not going to be enough,” said Holt-Lunstad.
Olsen and Fischer understand that a robotic pet might not provide high-quality social connection for every senior. Olsen said these pets are only one tool that NYSOFA is using.
But for certain seniors, robotic pets can make difficult transitions easier by centering the experience around the pet. “It sort of becomes about the pet as opposed to the thing” that is scary, said Fischer.
Macura hopes more seniors have access to robotic pets. “Especially the older senior citizens that are living alone. They should have companionship, good companionship,” she said.
(NEW YORK) — While experts and advocacy groups applauded the U.S. Supreme Court’s decision Thursday to not restrict nationwide access to the abortion pill mifepristone, they warn access to medication abortion remains at risk — as does the very foundation of the Food and Drug Administration’s regulation of all medications.
The court unanimously struck down a lawsuit seeking to restrict nationwide access to mifepristone, one of the two pills used in an abortion medication regimen. The court ruled that a group of doctors have no grounds to bring the lawsuit that sought to roll back the FDA’s approval of mifepristone.
While it is only recommended for up to 11 weeks of pregnancy, the abortion pill regimen is the least expensive form of abortion care and has become the most common form of abortion care in the U.S.
Medication abortion accounted for 63% of U.S. abortions in 2023, according to a study from the Guttmacher Institute in March, and its use is growing. Medication abortions accounted for just 53% of all abortions in the U.S. in 2020, according to Guttmacher, a research and policy group that advocates for reproductive health.
Women in states where abortion care has ceased or is restricted can still access the pills by mail under Thursday’s ruling — the biggest impact from the Supreme Court’s decision.
“The idea of limiting access to mifepristone will just further exacerbate disparities that we’re already seeing in terms of reproductive health care,” said Dr. Reshma Ramachandran, a family physician, health services researcher and assistant professor at Yale University School of Medicine.
Women who take the abortion pill can also go back to work or their daily lives quicker and patients see less days of bleeding and the likelihood of profound blood loss, Ramachandran said. The need to be seen by a physician is also reduced with the abortion pill regimen, compared to surgical abortions, she added.
At least 17 states have ceased nearly all abortion care since the U.S. Supreme Court overturned Roe v. Wade nearly two years ago.
Impact on abortion care Ramachandran called the Supreme Court decision “a relief.”
“While it is great that they dismissed it, the rationale for it is not as comforting because that just introduces the possibility that other groups where standing can be established could raise the same challenge and could work to limit access to mifepristone,” said Ramachandran.
“I’m very cognizant that this still allows for additional challenges to come forward before the courts,” Ramachandran said.
The American Civil Liberties Union also warned that the ruling was not the end of challenges to the abortion pill.
“Although the Court refused to allow these particular people to bring this case, anti-abortion politicians are waiting in the wings to attempt to continue pushing this case before an extremist judge in Texas in an effort to deny people access to medication abortion care,” Jennifer Dalven, director of the ACLU Reproductive Freedom Project, said in a statement.
The Guttmacher Institute also warned that mifepristone plays a key role in ensuring that many people safely self-manage their abortions, saying people need to remain “vigilant” with the anti-abortion movement continuing to try and risk care nationwide.
“We are relieved by this outcome, but we are not celebrating. From the start, this case was rooted in bad faith and lacking any basis in facts or science. This case never should have reached our nation’s top court in the first place and the Supreme Court made the only reasonable decision by leaving access to medication abortion using mifepristone unchanged,” Destiny Lopez, the acting co-CEO of the Guttmacher Institute, said in a statement.
The Supreme Court has not yet issued a decision on another case on its docket this term that could have a wider impact on lifesaving emergency abortion care across the country, including states that ban the procedure. The other case — Moyle v. U.S. — centers on Idaho’s total abortion ban, which prohibits the procedure at all stages of pregnancy, with exceptions to save the life of a pregnant woman or in cases of rape or incest.
A Biden administration lawsuit challenging the ban argues that it violates the Emergency Medical Treatment and Labor Act — a federal law that requires emergency room physicians at hospitals that receive Medicare funds to provide stabilizing health care to all patients whose health is in jeopardy.
It is now up to the court to determine whether the law, known as EMTALA, supersedes Idaho’s abortion ban and protects physicians’ ability to provide lifesaving abortion care. A decision in that case will be more consequential to abortion access across the country.
Impact on FDA approval process At the heart of FDA v. Alliance for Hippocratic Medicine — the case decided Thursday — was a fear that a Supreme Court decision could inject judges into decisions made by the experts at the FDA, not just for mifepristone but potentially other drugs.
“A number of us have been watching these court cases, and have been worried about the idea that judges — without clinical or technical expertise — would be weighing in on the scientific decisions that are being made by the FDA,” said Ramachandran, who is also the chair of Doctors for America’s task force on FDA policy.
At least for now, the ruling keeps the power in the hands of the FDA.
“It’s a very lengthy process to be able to get drug approval. There’s multiple review teams of scientists, doctors, statisticians, basic scientists, they’re all involved in looking at the data and making a determination if the drug is safe and effective for the indicated use before it comes into the market,” Ramachandran said.
“As a doctor, I look to the FDA and providing reassurance that what they approve is truly safe and effective. … It’s very much a rubber stamp,” Ramachandran said.
The FDA is also then responsible for ensuring the safety of drugs once they are on the market, according to Sanket Dhruva, an assistant professor at the University of San Francisco School of Medicine who studies FDA regulation of drugs and medical devices.
The FDA went “above and beyond in terms of regulatory standards approval for mifepristone,” because of the politicization of abortion care and the anticipation that there would be a number of different stakeholders looking at the drug, Ramachandran said.
Had the court ruled differently, there was wide concern that it would set the dangerous precedent that judges — who may not have the requisite expertise — would limit patient access to products, Ramachandran said.
“It would also rather politicize the FDA’s approval process, [for] drugs for gender-affirming care, for instance, and other reproductive health care — medications, contraception — which is kind of bizarre,” Ramachandran said.
Had the Supreme Court ruled differently it could have been “catastrophic” for drug development and regulation in the U.S., Dhruva said.
“It could have potentially cast out on the FDA being the determinant of what drugs meet the safety and effectiveness threshold to be on the United States market,” Dhruva said.
“There could have been larger issues for the drug development ecosystem because the industry might also have been more reluctant to invest in the whole process of drug development if there was this risk that the FDA might approve it. But then stakeholders — whoever had whatever interest — might come to the courts and the courts might invalidate the FDA’s ability to approve a device,” Dhruva said.
If the court had determined that the FDA’s authority over safety and fitness of drugs could be overturned, it would have led to a “significant thawing of industry investment in pharmaceuticals,” and threatened the development of new drugs, Dhruva said.
“I think it would have significantly threatened the development of drugs for conditions that we really need,” Dhruva said.
