Led by Eric Song, an associate research scientist and resident physician at the School of Medicine, the researchers found that injecting vaccines directly into the eyes of mice can activate an immune response, potentially protecting mice from brain infections caused by the herpes simplex virus. According to Song, their findings demonstrate that physicians could use the eye’s immune response to help fight bacteria and tumors. 

“We hear this phrase a lot: ‘the eye is like a window to the brain,’” Song told the News. “That’s kind of centered around this idea that the eye is central nervous system tissue, like the brain.” 

Song explained that when diseases affect the neurons, they are often observable in both the brain and the eye’s retina. His study demonstrated that immune reactions in the retina mirror those in the brain. His team discovered that stimulating the immune system in the retina can also protect the brain against diseases and tumors. 

“I think it’s important because this opens up a new anatomical avenue that hasn’t been described before,” Song said. “Our paper is the first to really show that there’s functional lymphatic vessels.” 

Song and his team primarily study “immune privilege,” a concept initially proposed in the 1940s which suggests that immune responses are significantly reduced in the brain and eyes. For a long time, the scientific community believed that these organs were immune-inactive, Song said. However, infections and autoimmune diseases still occur in these sites, which indicates that there is a present immune response distinct from other parts of the body. 

Song and his team previously discovered that the brain and eyes lack traditional lymphatic vessels, which help drain proteins and fluids. However, they identified that the membrane tissues surrounding these organs do contain lymphatic vessels, and physicians can manipulate these vessels to enhance immune responses.

The eye’s anterior and posterior compartments have different drainage systems to the lymph nodes, parts of the immune system that filter substances in the lymphatic fluid and contain white blood cells to help the body fight infections. 

In this study, Song and his team found that the posterior compartment drains through the optic nerve, which can be enhanced or inhibited to affect immune responses. Lymphatic vessels at the back of the eye and those surrounding the brain are interconnected and drain into the same lymph node, which facilitates a coordinated immune defense.  

They also discovered that blocking the lymphatic system’s communication in the optic nerve can reduce the immune system’s reaction to adeno-associated virus. This virus is often used in gene therapy, a technique that modifies a person’s gene to treat or cure a disease. 

They found that when the herpes vaccine is injected into the eye, it induces an immune response. By blocking this response, gene therapy could be more effective, as the vector viruses will not be attacked by the immune system, enabling the modification of genes. 

Ellen Foxman, a professor of immunobiology at the School of Medicine, noted that one of the initial FDA-approved gene therapies for a genetic eye disease had little effect because the body created an immune defense against the virus used to deliver the gene therapy. But now, Song and his team’s study offers a method to suppress this immune response, potentially enhancing gene therapy’s effectiveness. 

“It’s really exciting because there’s sort of a lore that the eye is an immunologically privileged site,” Foxman said. “It’s just that you don’t have any immune responses against things in the eye and the brain. But this challenges that dogma and says, ‘Well, let’s see, is that really true?’”

According to Akiko Iwasaki, Sterling Professor of Immunobiology at the School of Medicine, certain individuals have mutations or deficiencies in gene expression that lead to eye diseases. But gene therapy can compensate for these missing genes and introduce them to the body via viral vectors. While previously these vectors were quickly eliminated from the eye, Song’s findings suggest that scientists could obstruct this draining and prevent an immune response that would typically flush out this vector. 

“It’s significant because [the study] has many clinical implications,” Iwasaki said. “Now that we understand this new lymphatic drainage system, and [Song] manipulated it to enable gene therapy more efficiently. Other drugs can also benefit from this new knowledge and strategy of either blocking or enhancing the posterior eye drainage.”

Iwasaki also said that Song’s technique could be leveraged to use for gene therapy in the eye. 

The discovery opens up new avenues for treating a variety of eye-related diseases. Currently, Song and his team are investigating how their findings could be useful for treating other diseases that affect the eye, such as glaucoma and macular edema. He said that he will continue to look at other features of the nervous system and if there are other barriers to allowing effective immune responses.

“I think there’s still a lot of work to be done in order for anything to be translational,” Song said. “It should be our job and other labs to really focus down on specific diseases of the eye or the brain and see how this applies in those settings.”

Iwasaki also said scientists should conduct clinical trials to ensure the techniques are both effective and safe before applying their discoveries to human therapies. Nevertheless, Iwasaki said he is optimistic for its use in future clinical practice. 

“I suspect that translation of this finding is relatively straightforward,” Iwasaki said. 

The concept of gene therapy first arose in the 1960s. 

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IVF is the most widely used type of assisted reproduction — methods used to help patients who struggle to conceive. For Molly McAdow, assistant professor of obstetrics, gynecology and reproductive sciences at the School of Medicine, it’s a procedure she sees frequently.

“I take care of many, many, many patients who have undergone IVF,” McAdow said. “Most families that use IVF use it because they want to have a family, they want to have children, and they are unable to do that spontaneously on their own. They choose to do that in order to have children that are more biologically related to them.”

The IVF process involves a combination of egg retrieval, fertilization in a lab and the eventual transfer of an embryo to the uterus. First, a patient usually takes medication to stimulate the ovaries to release eggs, which doctors can collect. These eggs are fertilized in a lab using sperm cells from a partner or a donor. These resulting embryos are cultured in the lab until they are ready to be implanted back into the patient’s uterus, where they develop into an infant.

According to McAdow, some families also opt for IVF when pregnancy poses a health risk due to medical conditions, such as polycystic ovary syndrome, endometriosis or autoimmune disorders. Through IVF, people with those conditions can create embryos that can be implanted into a surrogate’s womb that can carry the embryo until birth — safeguarding the patient’s health or preventing the worsening of their medical condition during pregnancy. 

IVF also offers the possibility to screen embryos for severe genetic disorders like Huntington’s disease, McAdow added, saying that it ensures that debilitating genetic diseases are not passed on to a young child.

Alabama’s contentious Supreme Court case stems back to December 2020, when a hospital patient wandered into a storage area — a “cryogenic nursery” — containing frozen embryos at a fertility clinic. The sub-zero temperatures, however, freeze-burned the patient’s hand, causing the patient to drop the embryos on the floor and kill them, according to the Supreme Court’s majority opinion.

Even though the parents had already conceived children through IVF, the IVF process typically produces more embryos than can be implanted into a patient’s uterus. The fertility clinic had cryopreserved those extra embryos so that if the parents would later decide to have another child, they would not have to repeat the long process of hormone therapy and surgery. 

After the resulting destruction of their embryos, the parents filed lawsuits against the clinic and the hospital. But at a trial court in Mobile, Alabama, the lawsuit alleging wrongful death under an Alabama statute was dismissed. The court ruled that in vitro embryos do not qualify as children or people under Alabama’s Wrongful Death of a Minor Act, a statute that allows parents of a deceased child to seek damages for their child’s death. 

After the plaintiffs appealed the decision, however, Alabama’s Supreme Court reversed the ruling. As a result, the Supreme Court decision extends legal recognition of personhood to in vitro embryos, as well.

“The central question … is whether the Act contains an unwritten exception to that rule for extrauterine children — that is, unborn children who are located outside of a biological uterus at the time they are killed,” Justice Jay Mitchell wrote in the Court’s majority opinion. “Under existing black-letter law, the answer to that question is no: the Wrongful Death of a Minor Act applies to all unborn children”

Mark Mercurio, the director of the Program of Biomedical Ethics at the School of Medicine, said he recognizes that many people believe that human rights begin at conception and consider embryos as human lives. 

“I see why someone might come to that conclusion,” Mercurio said. “I don’t personally agree with it.”

For several fertility experts, the News spoke with, the decision sounded alarm bells. For McAdow, the pressing concern for providers and patients isn’t the philosophical question of when life begins. Rather, she raised concerns about individuals’ ability to start families through IVF, when otherwise, they might be unable to conceive.

“I think this idea of life beginning at embryo when an egg is fertilized just isn’t the point to me,” she said. “This decision would really significantly hinder the ability of families who want to be loving parents to be able to have children. I disagree with the concept.”

Sandra Ann Carson, the section chief of reproductive endocrinology and infertility at the School of Medicine who oversees the IVF program at the Yale Fertility Clinic, also raised concerns about the decision and its impact on how IVF clinics operate. The court’s decision to grant embryos the same rights as minor children, she said, might leave physicians and clinics liable for criminal charges in cases where embryos are lost or discarded. 

The ambiguity as to whether IVF physicians, clinics or parents would be held accountable for the embryo’s destruction raises a maze of legal questions for healthcare providers — and some have already reacted. In light of this recent ruling, the University of Alabama at Birmingham, a major public health provider in Alabama, has paused IVF procedures. 

Carson said she is concerned that if IVF procedures are paused, physicians and clinics might not resume services due to legal uncertainties surrounding embryo management and responsibility in case of damage. She also said she believes that the precedent could leave patients in Alabama who need IVF without fertility options. 

“If those embryos are destroyed, that would be like destroying a minor child,” Carson said. “That’s why [clinics] have paused IVF because they don’t quite understand what that would mean in reality. I think it’s probably not a good idea for many reasons, the least of which is that women or couples who need in vitro fertilization are probably going to be put in a very difficult position.”

McAdow expressed concerns about the disparities of access for those seeking IVF. In particular, she noted that wealthier individuals are more able to afford out-of-state options, while poorer people may be stuck, she said. 

According to McAdow, the decision will especially affect women for whom pregnancy poses health risks and were considering using a surrogate. These patients might then seek surrogacy services outside their state. However, the disparity is exacerbated by the fact that many individuals don’t have the financial capability or access to surrogacy options elsewhere, McAdow said.

“Some of those people who have the most access to resources will be able to travel out of state and will find an alternative,” McAdow said.  “The more affluent and well-connected individuals in Alabama will be able to go elsewhere to grow their family.”

Both Carson and Mercurio questioned the legal implications of considering the embryos as children. 

“You could say everything from if you decide that fertilized eggs have the same rights as children, so can folks write them off on their taxes?” Mercurio asked. “Do they count as you determine congressional representation? I mean, do they count in the census? If they’re children, then they can’t be considered property.”

For Mercurio, this issue is a part of the broader U.S. “culture war.” He said that those advocating for fertilized eggs to have the same rights as born children will struggle to adapt their beliefs to the opinions of others. 

“If you have that belief, it’s going to be very hard to reconcile that with the way so many other people in society feel,” Mercurio said.

The first IVF birth occurred in 1978.

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The study, led by Nikolai Jaschke, a postdoctoral researcher in the lab of Andrew Wang, an internal medicine professor at the School of Medicine, found that the introduction of A485 in mice offers a short-term but significant increase in white blood cell counts. A485 is a small molecule — colloquially known as “prohiberin” — that inhibits proteins that modulate gene expression. The researchers hope that the discovery could help human patients with neutropenia, or low white blood cell counts, which is common in those fighting infections and undergoing chemotherapy.

“At this point, from what we know in mice, it seems reasonable that a lot of patients receiving chemotherapy could benefit from this molecule,” Jaschke said. “But it’s not clear if that’s the case and it needs to be tested in clinical trials.”

Jaschke told the News that he first became interested in A485 after researchers from the pharmaceutical company AbbVie and other institutions first published a study in 2017 detailing how it could be used to treat various malignancies.

However, the research team never followed up on the study. A few years later, Jaschke and his team decided to study whether A485 could help restore bone marrow function, hoping to analyze the molecule from a pharmaceutical rather than oncological perspective. From a new scientific viewpoint, they discovered another use for A485.

“We kind of stumbled across [the discovery] in a very different context because we were interested in a pharmaceutical mechanism or pharmacological mechanism to restore bone marrow function,” Jaschke said.

Because many patients with bone marrow failure are more likely to have infections due to diminished white blood cell counts, the researchers explored whether the injection of A485 molecules could help save mice suffering from myelodysplastic syndrome, a group of cancers in which blood cells in the bone marrow don’t properly develop, and chemotherapy-induced bacterial infections, some of which were potentially lethal. 

They found that almost a third of the mice treated with A485 therapy survived, suggesting its potential use as a therapeutic intervention. Jaschke argued that there is currently no available pharmacological remedy with similar capabilities to what A485 expressed in his team’s mouse model.

Jaschke compared the A485 molecule with G-CSF, a glycoprotein hormone that stimulates the bone marrow to increase the number of white blood cells in the bloodstream. He noted that while many doctors prescribe G-CSF to patients undergoing chemotherapy, many still experience low blood counts and subsequent infections. Once they are reinfected, their treatment options are limited to antibiotics, fluids and supportive care.

Lourdes Mendez, assistant professor of hematology at the School of Medicine, is dedicated to both the clinical care of patients and translational research to identify novel therapeutics in high-risk myeloid neoplasms and leukemia to improve clinical outcomes for patients. She told the News, “Neutropenic fever and sepsis remain a critical problem in our field particularly for patients with acute leukemia. This study on A485 raises the exciting possibility that our toolbox, which is currently limited to G-CSF, could expand by targeting p300 HAT activity.”

In contrast, the A485, Jaschke said, could be used in concert with G-CSF to help increase white blood cell counts. Though A485 is a synthetic molecule, it does not need stem cells to proliferate, unlike G-CSF. 

Still, other researchers are cautiously optimistic about the study and A485’s future. In an interview with the News, Andres Hidalgo, a professor of immunobiology at the School of Medicine, noted that the study was conducted with mouse models and was not tested directly next to G-CSF.  

“If [A485] is better than G-CSF, I think that might be a little bit of an overstatement at this point,” Hidalgo said. 

Similarly, Jaschke said that he is unsure whether the promising results will be replicated in future experiments in human subjects. 

“I have no idea if it will even provoke the same effects in humans as it did in mice,” Jaschke said. “This needs to be tested and this needs to be seen, which requires clinical studies, which are very expensive. I don’t know if someone will look into this.”

Jaschke also highlighted several other challenges with their investigation. First, he noted that while the molecule responded effectively to the bacteria Listeria, researchers need to conduct further testing to determine the molecule’s efficacy against other common pathogens, such as pneumococci, staphylococci and E. coli, among others.

He also expressed concerns about the consequences of a potential excessive immune response due to the significant increase in white blood cells induced by the molecule. Jaschke compared the strong immune response to immune checkpoint inhibitors, a set of immunotherapies that are often used in cancer treatment but can sometimes lead to an overly robust immune response. 

He lastly conveyed that they have extensively characterized the compound, addressing many important questions regarding its efficacy and safety. They believe that further confirmation through testing in various models by different laboratories is necessary to validate their findings, particularly regarding the compound’s effectiveness against a wide range of pathogens and in different models of bone marrow injury.

Lohith Gowda, an assistant professor of hematology at the School of Medicine, raised concerns about A485 beyond its safety.

He also discussed the effects of prolonged neutropenia and whether it can lead to altered immunity. 

“Can A485 alter or interact differently with microbiomes?” Gowda questioned. “Can [it] help build a different story if favorable?”

Jaschke also emphasized the need for other laboratories to validate their findings and learn more about the safety and efficacy of the compound in humans. Nevertheless, his lab does not plan on conducting further research with the molecule in the near future.

“That’s not something that we will do necessarily because we have described what we found,” Jaschke said. “From that perspective, we are done.”

About 35.5 million individuals in the United States suffer from neutropenia.

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The reproductive endocrinologist and ovarian biologist recently developed a mathematical model that can predict outcomes for delayed menopause using a technique called ovarian tissue cryopreservation, in which tissue from the ovaries is extracted, frozen and transplanted years later into the body. 

Published in the American Journal of Obstetrics & Gynecology, Oktay’s model predicts that harvesting tissue from the ovaries at earlier adult ages and using better transplant techniques can delay menopause and extend the timeframe in which women might be able to have children. He said he sees a future where people could use the process, which freezes tens of thousands of eggs from ovarian tissue, to delay menopause for several decades.

Done effectively, Oktay believes, it might even avert menopause altogether. 

“He’s extending it from just trying to preserve somebody’s ability to have a child to potentially preserve somebody’s reproductive lifespan in a way that is not just about preserving childbearing, but preserving all of the hormones … that prevent a lot of medical problems,” said Hugh Taylor, the chief of obstetrics and gynecology at Yale New Haven Hospital, of Oktay. “It is very exciting work he’s doing, and we’re lucky to have the world’s leader here.”

Oktay is known for spearheading transformative advancements in the field of women’s reproductive health. He performed the world’s first ovarian transplantation with frozen — or cryopreserved — tissue in 1999, which was later published in the New England Journal of Medicine in 2000. 

The procedure was considered experimental until 2019 when the American Society of Reproductive Medicine announced in a committee opinion that ovarian tissue cryopreservation could be considered an established medical procedure.

Menopause is a natural biological process that usually occurs around the age of 50. It signals the end of monthly menstruation due to loss of ovarian follicular function: the ovaries stop releasing eggs for fertilization. 

According to Mary Jane Minkin, a practicing gynecologist at the School of Medicine with a focus on menopause, the disruption of normal fertilization cycles can make it challenging for people to have children. 

“Once you go from 40, say 42, 43, you get a pretty significant decline [in reproduction],” Minkin said. “And once we get beyond 43 or so, it’s reasonably tough to have a kid. It doesn’t mean it doesn’t happen, but your chances aren’t fabulous.”

According to the National Institutes of Health, menopause symptoms including heat flashes, mood changes, weight changes, trouble sleeping or depression. Some people experiencing menopause consult their doctors about lifestyle changes, while others are prescribed medications to alleviate symptoms. 

By surgically removing and freezing the parts of the ovary that contain immature egg cells, Oktay’s cryopreservation process might be able to postpone that process. Years after freezing the ovarian tissue, doctors could thaw out those tissue samples and transplant them back into the body, returning a pool of healthy, unused egg cells.

For women receiving treatment for cancer or other diseases that affect the ovaries, cryopreservation can be a game-changer. Many common cancer therapies can disrupt a patient’s fertility and hormone production, preventing them from having children in years to come.

Through cryopreservation, doctors can remove and freeze a healthy portion of a patient’s ovaries before treatment starts. Years later, after chemotherapy, surgery, or radiation therapy, that tissue can be transplanted back into the body — theoretically making pregnancy possible once again. 

Re-inserting the ovarian tissue also allows the body to restart the natural production of hormones like estrogen, effectively delaying the onset of menopause and the physical symptoms associated with it. According to Oktay, women who experience late menopause face lower rates of depression, osteoporosis, cardiovascular disease and Alzheimer’s disease.

The procedure

For patients who undergo Oktay’s cryopreservation procedure, the process typically takes an hour. Cuts are made through the bikini line and the belly button, and doctors remove the outer layer of one ovary. The patient goes home the same day, Oktay said. 

Then, the tissue is put through a freezing process that takes three to five hours before being stored in liquid nitrogen at a long-term tissue storage facility. The tissue can last for decades if needed, Oktay added.

Compared to other methods of fertility preservation, like egg freezing, ovarian cryopreservation has the advantage of scale. 

During traditional fertility treatments, a combination of medications and procedures designed to stimulate the ovaries might yield approximately 10 or 15 eggs that are subsequently frozen, Oktay said. When those frozen eggs are retrieved, Oktay estimated, about 80-90 percent might survive; doctors might be able to fertilize three or four embryos, which may grow into one or two babies.

For Oktay, though, ovarian freezing could be a better solution. With ovarian tissue freezing, doctors can freeze and harvest portions of the outer ovary itself, which Oktay calculates could contain tens of thousands of eggs. By freezing and re-transplanting pieces of the ovary in the future, the process could scale up the number of potential, unfertilized eggs that women might have in reserve.

Like egg freezing, ovarian freezing can improve fertility, allowing people to become pregnant and have children at older ages. As of 2019, scientists have documented more than 130 live births after transplanting of cryopreserved ovarian tissue, and almost all patients recovered their ovarian function after the implantation procedure.

By delaying menopause, freezing the outer ovary could also help maintain natural hormonal function for longer and alleviate the symptoms associated with hormone changes during menopause.

Sometimes, more ovary transplants, Oktay said, could mean delaying menopause even longer.

“If that [ovary tissue] starts running out, you can come back and put more tissues and extend [fertility for] 20 years,” Oktay said. “So egg freezing is kind of a one-shot deal just for fertility. Ovarian freezing is to restore natural hormone production and, if desired, fertility for a protracted period of time.”

A model to end menopause

Using data from previous research that counted a woman’s egg reserves at different ages, Oktay designed his new mathematical model to predict how long — and how effectively — the surgery could delay menopause. 

Based on the model, the researchers also developed an interactive online tool to calculate menopause delay, based on patient age, the amount of the outer ovary removed, and the number of ovarian follicles — the fluid-filled pockets in the ovary that release monthly egg cells during ovulation — that survive the freezing process.

Their research found that the amount of tissue removed during the procedure is tied to the amount of time menopause can be delayed. The more tissue a surgeon removes, the longer the procedure can delay menopause. However, if doctors remove too much tissue from the ovaries, it may result in early menopause.

Age was also a key factor, Oktay said. If patients undergo the ovarian freezing procedure before they turn forty, they typically get at least five years of menopause delay. 

By transplanting back portions of the harvested, frozen ovary tissue over several procedures instead of all at once, menopause can be delayed even longer, the model indicated. Returning a third of the outer portion of the ovary at a time over three procedures delayed menopause longer than returning all the tissue through one surgery. 

If younger patients undergo the procedure in combination with a split-up retransplantation process, menopause might not even be a consideration, Oktay said.

“If done before 30, or closer to mid-20s, and if you end up transplanting [the ovarian tissue back] in fractions, you may get 50 to 60 years in delay, which means the elimination of menopause,” he told the News. 

However, for Lubna Pal, the director of the menopause program at the Yale School of Medicine, that idea seems unrealistic in practice.

“In my mind, having your ovaries removed in your 20s so that you’re planning to achieve a pregnancy in your 60s doesn’t make sense to me,” Pal said. 

‘Not just a mere academic exercise’

For Oktay, developing the model is about more than just mathematics. As a practicing reproductive endocrinologist, he sees patients every day facing health challenges related to menopause.

“It’s also clinical for me. I’ve seen how severely my patients suffer from menopause complications,” he said. 

“This is not just a mere academic exercise,” Oktay said. “There are 26 years on average a woman spends in menopause, which for many women is associated with significant health complications … So far, nobody’s addressed menopause directly. I foresee that in the next four to five years, this is going to become more mainstream. You could have it even sooner.” 

However, Minkin is more skeptical about the imminence of widespread cryopreservation. Without widespread insurance coverage, the procedure is expensive. Insurance companies usually don’t pay for elective procedures involving cryopreservation, Oktay said, but situations are sometimes decided on a  case-by-case basis. 

Oktay, however, insisted that insurance companies would recognize cryopreservation as a preventive treatment to minimize the rising cost of menopause symptoms and treatments. A 2023 study by the Mayo Clinic found that missed workdays because of menopause symptoms cost the U.S. economy $1.8 billion in the previous year.

For now, though, the often uninsured cost of the procedure remains a sticking point. As is the procedure’s invasiveness in women’s bodies. 

“I just don’t see it happening,” Minkin said. “Right now, for a fairly small amount of money, I can give people estrogen and progesterone, which are the hormones that the ovaries make primarily, for a heck of a lot less money than it’s going to take to do these procedures.”

The biological problem with ovarian cryopreservation, though, is an increased risk of cancer. According to Pal, extending exposure to natural reproductive hormones for longer time periods is linked with an increased risk of cancers, including breast and endometrial cancer. It’s a process that happens during chronological aging, she said.

Since transplanting the frozen ovary tissue back into the body can restart natural hormone production for women, Pal is wary that the technique may have unintended consequences.

“What would it mean for that female?” Pal said. “It may be good for her bones, questionably better for cardiovascular health, but what about breast cancer risk? What about endometrial cancer risk?”

But that increased risk of cancer, Oktay pointed out, is also true for women undergoing more conventional menopause treatments like hormone replacement, in which patients take medication to replace declining estrogen levels in the body. Eleven percent of women also naturally experience late menopause after the age of 55, placing them at a higher risk for cancer, regardless of therapy.

In his experience, the breast cancers linked to hormone replacement tend to be more “aggressive” than those associated with naturally late menopause, Oktay said. In the case of cryopreservation, which prompts the body to restart its own hormone production, Oktay believes the risks may be worthwhile.

“If you’re going to take hormone replacement versus having late menopause, you’d rather have late menopause,” Oktay told the News. “Women who take birth control pills also have increased breast cancer risk. But we still take them because the benefits outweigh the risks.” 

‘Thoughtfulness, pause and responsibility’

Laura Bothwell, an ethicist and historian of public health at the School of Public Health, also pointed out “myriad” ethical dilemmas that the procedure poses. By delaying menopause symptoms, ovarian tissue cryopreservation could reduce premature morbidity and prolong periods of healthy living — outcomes that Bothwell considers to be “ethically valuable.”

But she highlighted concerns that the procedure could shift the idea of menopause: altering it from a natural biological process to a medical problem that needs a fix.

“Interventions that fall outside the realm of healing maladies and instead pathologize what it means to be human and the normal human life cycle become ethically suspect,” Bothwell said.

As a result, some experts said they believe that Oktay’s work, while promising, needs a more careful look.

“It’s tremendously interesting, intriguing, and exciting that people are looking into this,” Pal said. “But the translation from science to clinical application requires tremendous thoughtfulness, pause and responsibility.”

“This whole extending menopause is a brave new world,” Taylor added. “I think it has tremendous possibilities, but again, has to be carefully studied.”

Approximately 1.3 million women enter menopause per year in the United States, according to the NIH. 

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Lipska is a professor of medicine at the School of Medicine who specializes in endocrinology and diabetes. On Dec. 14, she testified at the Senate Health, Education, Labor and Pensions Committee hearing titled “What is Fueling the Diabetes Epidemic?” During the hearing, she underscored the need for the federal government to negotiate with pharmaceutical companies to lower drug prices to address the root causes of diabetes and obesity. 

Many of Lipska’s patients suffering from Type I Diabetes — a chronic condition where the pancreas produces little-to-no insulin, the hormone responsible for regulating blood sugar levels — spend nearly half of their household income on insulin, which is vital for them to stay alive. Many also struggle to afford medications such as Ozempic — the brand name for semaglutide, which the FDA approved to treat Type II Diabetes — or Wegovy, another brand name for a similar drug approved for weight management. 

“I see patients in clinic who struggle paying for the medicines and often don’t take their medicines because they cost too much — and I see the consequences,” Lipska said in an interview with the News. “I get very upset about this, and I get very angry at our healthcare system because people suffer when they cannot afford the medications they need.”

On the stand, Lipska presented evidence from a 2017 survey conducted at the Yale Diabetes Center which showed that one in four diabetes patients who were prescribed insulin had to ration the medication due to cost. According to Lipska, though recent advocacy efforts have led to a decrease in insulin prices, the medication remains expensive.

These novel medications are not cheap. Patients with Type II Diabetes — a condition in which insulin is unable to lower a patient’s blood sugar — often pay over $900 per month for Ozempic. Similarly, patients suffering from obesity have to pay $1,300 a month for Wegovy. Patients must take these medications continuously for an indefinite period in order to maintain their ongoing effects. 

“Patients are looking at a potentially lifelong treatment and could be facing the most expensive subscription service in the history of medicine,” Lipska told the News.

In the hearing, Lipska noted that if Medicare were to cover Wegovy for its beneficiaries with obesity, American taxpayers would have to pay $268 billion. 

Further, according to a study conducted by Luan Yu, a cardiologist and assistant professor of medicine at the School of Medicine, the populations least able to afford these treatments are the ones who need them the most.

“We found that these minority populations who have higher prevalence of obesity also have more financial barriers, in terms of accessing healthcare and afford[ing] the medications,” Lu told the News.

However, other countries are avoiding these steep costs. Lipska testified that Ozempic costs $100 per month in Sweden and just $80 in Australia and France.

In contrast, patients in the U.S. must pay 10 times that amount. For Lipska, the lessons learned from insulin affordability should inform how the government negotiates prices with pharmaceutical companies for novel medications like Ozempic.

“The Inflation Reduction Act already authorizes the Secretary of the Department of Health and Human Services to negotiate prices with pharmaceutical companies under specific provisions, and for a limited set of drugs,” Lipska told the Senate.

According to Lipska, this process involves aligning the launch price with the drug’s value and what patients can afford. She argued the government should sit at the negotiating table with pharmaceutical companies such as Novo Nordisk, the developer of Ozempic which has a market value higher than Denmark’s GDP. 

Still, Lipska emphasized the need to tackle diabetes and obesity upstream, instead of relying on drugs. For her, more long-term preventative solutions, such as reducing food deserts, are more favorable than using weight-loss medications. 

“In cardiovascular disease prevention, we always talk about prevention being more cost-effective than management or treatment,” Lu told the News. “It’s better to prevent people from becoming obese. Then, if they become obese, you treat them.”

In the hearing, Senator Bernie Sanders — chair of the Senate Health, Education, Labor and Pensions Committee — underscored Lipska’s call to action. 

“Nearly 30 years ago as I think we all know and the American people know, Congress had the extraordinary courage to take on the tobacco industry whose products killed nearly 400,000 Americans every year including my father,” he said. “Now is the time for us to seriously combat the Type II Diabetes and obesity epidemics in America.” 

Over one in 10 people in the United States suffer from diabetes.

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