‘Wild West’ peptide craze surges beyond GLP-1s as FDA faces pressure to ease access

As GLP-1 weight-loss medications gain traction, the peptide market is experiencing a surge in interest.

A variety of peptides — commonly marketed for weight loss, muscle building, injury recovery and other uses — have emerged as largely unregulated drugs sold through both licensed compounding pharmacies and unverified vendors.

The U.S. Food and Drug Administration is set to evaluate whether to loosen regulations on several peptides during a meeting this summer.

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Peptides are short chains of amino acids — the building blocks of proteins — that play key roles in biological functions, according to the National Institutes of Health. Peptide drugs are lab-made versions of natural molecules in the body that are designed to mimic or influence biological signals to treat disease, experts say.

Though the peptide market has been described as the "Wild West," demand remains strong, potentially challenging pharmaceutical giants that dominate the GLP-1 market.

Dr. Alex Tatem, an Indiana-based board-certified urologist with expertise in men’s health and peptides, discussed how "life-changing" GLP-1s kicked off the rise of peptides.

"They are incredibly effective at what they do when it comes to changing body composition, benefiting metabolic health, cardiovascular health [and] neurologic health," he said. "These are truly miracle compounds, and as a result we've seen an explosion of interest – not just on the pharmaceutical side or the doctor’s side, but from the general public."

According to Tatem, the challenge is that nearly all commercial GLP-1 products are administered in a single-dose weekly pen, which works for the "overwhelmingly majority" of patients, but not for everyone.

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"There are patients I can prescribe tirzepatide to and they can do OK with a once-a-week [dose], but they end up developing nausea with that initial injection – and then by the end of the week, they're hungry again."

Because some patients respond better to smaller, more frequent doses — an option not offered by commercial drugs — compounding, or the customization of medications, has grown in popularity, Tatem said.

"We've had compounding pharmacies that have now developed compounded versions of semaglutide and tirzepatide that allow that sort of dosing flexibility," he said.

"The reason compounders had to do this was because there was so much demand for GLP-1s that there was actually a national shortage."

Current legislation allows compounders to step in during widespread national shortages, according to Tatem, prompting the industry to invest millions of dollars into developing and manufacturing these drugs.

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Once commercial pharmaceutical companies could catch back up, compounders continued making these medications in smaller batches for custom doses, allowing for more patient accessibility.

"That creates a huge clash between commercial pharmaceutical companies and compounders, because commercial pharmaceutical companies view that as an infringement of their property," Tatem noted.

Tatem raised concerns about the FDA’s regulation of compounding pharmacies, warning that it could limit patients’ access to customized medications.

"That is a real concern for clinicians like me who really care more about patient access, making sure we can get the right medication to the right patients at the right time," he said.

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Some peptides have been widely administered for more than a decade without major health complications like toxicity or cancer, according to Tatem.

"These are compounds that haven't gone through the full FDA approval process that you would normally see for a commercial drug, [yet] we didn't see anything adverse," he said.

In September 2023, the FDA "quietly" tightened regulation of 19 peptides, making them illegal to manufacture and cutting off patient access.

"They seemed to be working and seemed to be efficacious for patients, and all of a sudden they were banned, which inadvertently ended up contributing to this surge in interest," Tatem said. "We kind of saw the same thing happen with peptides that we saw with prohibition."

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While the rising popularity of GLP-1 drugs has fueled growing public and regulatory interest in peptides, most of the so-called "trendy" peptides still are not available by prescription, according to Tatem.

They may help with injury recovery, skin rejuvenation, sleep improvements and boosting of natural growth hormones, he said.

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"These were all medications that were designed to help people live well and live as healthy as possible," the doctor told Fox News Digital. "And in reality, that was also their downfall in the American healthcare system, because if you are going to get a drug approved and to market, it has to treat a disease state."

Tatem confirmed that he’s seen a shift in patients confronting more than just baseline ailments, seeking advice on how to feel their best through new modes like testosterone therapy.

"The desire to function at our highest level is something that we all feel," he said.

While nothing replaces the fundamentals — getting eight hours of sleep, eating a high-protein diet and maintaining a fitness routine that blends resistance training and cardio — Tatem said individualized treatments such as peptides may help support those healthy habits.

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"If you end up pulling a tendon or pulling a hamstring, and you're just now starting to get some momentum in the gym, that’s really where peptides start to step in," he added.

Experts advise consumers to avoid gray-market products, to work only with qualified physicians and reputable pharmacies, and to treat peptides as part of a broader health plan — not a shortcut or risk-free supplement.

Fox News Digital reached out to the FDA, Eli Lilly and Novo Nordisk for comment.

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New obesity treatment may help preserve muscle during weight loss

During a recent episode of her podcast, Gwyneth Paltrow spoke with neuroscientist Dr. Andrew Huberman about retatrutide, a new advancement in GLP-1 (glucagon-like peptide-1) therapies.

In recent years, GLP-1 receptor agonists have become a major focus in discussions around biohacking, longevity and wellness – but they’re not without a multitude of side effects.

Huberman noted that while first-generation weight-loss drugs curbed users' appetites, they frequently plunged them into massive, rapid caloric deficits.

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Without aggressive resistance training, a high percentage of that lost weight came directly from lean muscle. "People would lose a ton of weight, but they would also lose muscle mass," Huberman told Paltrow.

That is where retatrutide comes in, he said. Unlike older single- or dual-action medications, retatrutide is a triple agonist.

That means it activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1) and glucagon – three hormones involved in regulating blood sugar, appetite and metabolism.

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"Retatrutide is a more mild agonist of GLP-1," said Huberman. "It also increases glucagon and ... GIP. So, it hits three different pathways, each a bit more subtly."

In clinical trials, retatrutide is administered as a once-weekly subcutaneous injection.

Because of its balanced, multi-receptor approach, Huberman said the drug has a "lower side effect profile" while still allowing people to lose up to a third of their body weight "across a year or so."

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Most importantly for fitness and longevity advocates, the doctor pointed out that retatrutide seems to have "some muscle sparing effect."

Because the drug is still moving through official pipelines, a massive gray market of compounding pharmacies and online peptide suppliers has cropped up to meet the growing demand.

Huberman issued a strict warning regarding these unregulated online sources, noting that these options "can say 99% purity, but that 1% means there could be some LPS," referring to lipopolysaccharides, a type of bacterial toxin.

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"LPS will cause inflammation," he cautioned. "One injection isn't gonna do it, but multiple injections over time, I could see where that could become problematic."

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Paltrow echoed the safety concerns, comparing the current "wild-west" peptide craze to the landscape of supplements in the 90s, "where there's really no third-party testing and it's kind of word of mouth."

Both agreed that anyone exploring these therapies should avoid unverified online sources and prioritize working with a medical doctor.

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Retatrutide is an investigational molecule that is legally available only to participants in Lilly’s clinical trials, according to the manufacturer's website. The company is currently "evaluating its safety and efficacy."

The drug has not been reviewed or approved by any regulatory agency, and no one should consider taking anything claiming to be retatrutide outside of a Lilly-sponsored clinical trial, experts advise.

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New drug approach offers hope for patients with recurrent aggressive cancers

A new treatment for endometrial cancer demonstrated strong potential in a Phase 3 clinical trial.

Drugmaker Merck announced Monday that the investigational drug sacituzumab tirumotecan (sac-TMT) met its "primary endpoints" of overall survival and progression-free survival in patients with advanced or recurrent endometrial cancer.

The TroFuse-005 trial is the first global Phase 3 trial to "demonstrate statistically significant improvement" in survival compared to chemotherapy in these patients, according to a Merck press release.

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This was also the first and only antibody-drug conjugate (ADC) to achieve such a result for endometrial cancer patients in this setting, the researchers stated.

An ADC is a targeted cancer therapy that delivers more of the drug to tumor cells while limiting damage to healthy cells.

The trial involved 776 patients with endometrial cancer whose disease worsened after receiving both platinum chemotherapy and immunotherapy.

The patients were randomly assigned sac-TMT, administered every two weeks, or a treatment of the physician’s choice, including doxorubin or paclitaxel chemotherapy. The patients were aware of which treatment they were receiving.

Those receiving sac-TMT showed "clinically meaningful improvement" in their disease state compared to the treatment of physician’s choice, the researchers found.

The study also met response rate benchmarks and exhibited similar side effects to earlier studies of the same drug, Merck reported.

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The drugmaker did not disclose any statistics on exact survival benefit, response rate, side effect rates or other details, but the researchers aim to present this Phase 3 data at an upcoming medical meeting.

Dr. Domenica Lorusso, the study’s global lead investigator and professor of obstetrics and gynecology at Humanitas University and Humanitas San Pio X in Milan, wrote in a press release that these results show sac-TMT "may be able to address a critical unmet need for certain patients with advanced endometrial cancer, one of the only cancers increasing in both incidence and mortality worldwide."

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"Despite recent advances, patients whose disease progresses following treatment with platinum and immunotherapy are urgently in need of new options, and these findings show for the first time that a TROP2 ADC may be an effective option in this setting," she added.

Dr. Brian Slomovitz, co-director of gynecologic oncology at Mount Sinai and an investigator on this trial, reflected on the study findings during an interview with Fox News Digital.

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"Unlike many other cancers that we are treating, the number of endometrial cancers and the number of deaths due to endometrial cancers are on the rise," Slomovitz noted.

"In the United States, the number of deaths due to endometrial cancer has surpassed the number of deaths due to ovarian cancer, [making it] the deadliest of all gynecologic malignancies."

Despite recent advancements introducing immunotherapy as the standard of care, "better treatment options" for patients with recurrent disease "remains an unmet need," Slomovitz commented.

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"If the full data confirm this announcement, the key questions will be the magnitude of the survival benefit and the toxicity profile — those will define sac-TMT’s role," he said. 

"But an overall survival improvement in recurrent disease is a real, meaningful result for patients and their families, not just a statistical one."

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Could Ebola spread to the US? WHO emergency sparks fears after American infected in Congo

The World Health Organization has declared an international public health emergency as a growing Ebola outbreak in Central Africa sparks concern that the deadly virus could spread beyond the region — including into the United States.

The outbreak has been linked to dozens of suspected deaths in the Democratic Republic of Congo (DRC) and neighboring Uganda.

Ebola is a zoonotic, viral disease that is rare but life-threatening, according to Cleveland Clinic. Outbreaks typically develop in areas of Africa, starting in species like antelope, fruit bats and nonhuman primates.

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There are four different Ebola strains, also known as orthoebolaviruses. Bundibugyo virus is the strain that has been detected in the DRC outbreak.

While the outbreak does not meet the criteria for a pandemic emergency, U.S. officials are warning Americans not to visit the area, escalating the State Department travel advisory from a Level 3 to Level 4 on Sunday.

One American tested positive for Ebola on May 17 while working in Congo and is being transported to Germany for treatment with other Americans who are high-risk contacts, according to the Centers for Disease Control and Prevention.

As of May 18, there have been 11 confirmed and 336 suspected cases, including 88 deaths in the DRC.

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"This is a rapidly evolving situation, and case counts are subject to change," the CDC noted.

While no cases have been detected in the U.S., there is a possibility that it could make its way into American territory, posing a threat to public health.

Dr. Jacob Glanville, a leading immunologist at Centivax in San Francisco, which is developing a universal flu vaccine, spoke with Fox News Digital about the potential spread of Ebola into the U.S.

The doctor noted that the virus has a two- to 21-day incubation period, during which an infected person can show no symptoms and the infection cannot be detected by tests.

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"It is thus possible for Ebola to move across international borders silently, bypassing screening," he said.

"Some travel restrictions from the affected area have been put in place to limit this risk, although as this outbreak was spreading silently for months, it is possible that an infected traveler had come to the U.S. in the past 21 days from the affected areas prior to the travel restrictions."

Glanville noted that while the outbreak is "growing rapidly," one week ago there were fewer than 500 global cases.

"Thus, the chance of an infected traveler having come to the U.S. remains quite low for the time being," he said.

Dr. Robert H. Hopkins, Jr., medical director of the National Foundation for Infectious Diseases, agreed that the threat to American communities remains low.

"The viruses that cause Ebola pose a very small risk, even to travelers to areas with outbreaks," the Arkansas-based expert told Fox News Digital. "This virus is transmitted only person-to-person via infected blood and body fluids from symptomatic people, and rarely from infected animals."

Ebola spreads through direct contact with infected blood, bodily fluids or remains of infected people or animals, including fluids such as saliva and sweat, according to Hopkins.

Cleveland Clinic notes that it is "very unlikely" for Ebola to be an airborne infection.

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The virus starts with flu-like symptoms, including fever, chills, fatigue, headache, muscle pain, vomiting/diarrhea and loss of appetite. Other signs may include a rash or spots of blood under the skin, hiccups, bruising and red, bloodshot eyes.

As the disease is a type of viral hemorrhagic fever, it causes damage to the blood vessels and can lead to more serious symptoms, including severe bleeding or hemorrhaging, neurological disorders and severe vomiting.

For those who have traveled to the outbreak area, Hopkins recommends monitoring for symptoms for three weeks after departing and seeking immediate care if symptoms develop.

Treatments are available, along with a vaccine that can help protect high-risk individuals and prevent further spread, according to healthcare professionals.

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Avoiding contact with blood, body fluids, and sick or deceased people and animals is "highly effective in the prevention of Ebola transmission," Hopkins advised.

"If contact is required, high-quality personal protective equipment is recommended before contact with potentially infectious people and/or materials," he added.

Fox News Digital’s Michael Sinkewicz and Andrea Margolis contributed to this report.

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Woman says she’s being held against her will after cruise ship hantavirus scare

An American woman who may have been exposed to hantavirus on board the MV Hondius cruise ship is now being forced to quarantine at a facility in Omaha, Nebraska.

Angela Perryman, 47, anticipated having to stay at the National Quarantine Unit for a short time after arriving last week, but on Monday she was served with a federal order to remain quarantined for at least two more weeks, she shared with The New York Times.

The order mandates that Perryman remains in the facility until May 31, which would be a total of 21 days after her arrival. Officials told her that any attempts to leave could result in law enforcement involvement, she said.

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"They won’t let us isolate at home," Perryman, who lives in Ecuador but has a home in South Florida, told the news outlet. "We’re being kept in a secured facility and threatened if we try to leave."

The woman shared that she received a negative hantavirus test result and is not experiencing symptoms. However, she said she did briefly speak with a passenger who later died from the disease.

The federal order, which the passenger shared with the Times, states that it could "constitute a probable source of infection to other people" if Perryman were to leave the facility to travel to another state.

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After receiving a medical review within 72 hours, Perryman was told she can appeal the order. She told the Times that she plans to take legal action.

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The quarantine unit includes 20 single-occupancy rooms with negative air pressure systems and en suite bathroom facilities, along with exercise equipment and Wi-Fi connectivity, according to the University of Nebraska Medical Center’s Global Center for Health Security website.

The quarantine order — issued under federal public health authority — was reportedly approved by Jay Bhattacharya, the acting head of the Centers for Disease Control and Prevention.

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Fox News Digital reached out to the CDC requesting comment.

Including Perryman, a total of 18 American passengers from the MV Hondius have been monitored at the quarantine unit since last week.

Seven other passengers who left the ship and returned home prior to the outbreak’s discovery are being monitored by their state and local health departments, per the CDC.

"The reason they’re watching these passengers so carefully is that the incubation period can be very long — up to six weeks — and when symptoms hit, patients can deteriorate very rapidly," Dr. Marc Siegel, Fox News senior medical analyst, said during a recent episode of "The Faulkner Focus."

"This is not something that spreads easily like COVID, but because the Andes strain has rare person-to-person transmission, public health officials are being extremely cautious," he added.

At least three people linked to the outbreak aboard the ship have died, while additional passengers have been sickened, according to the World Health Organization.

The federal government last imposed a large-scale quarantine order in January 2020, when nearly 200 Americans evacuated from Wuhan, China, the epicenter of the COVID-19 outbreak. They were required to remain in isolation for two weeks at the March Air Reserve Base in Riverside County, California, per the CDC.

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"Typically, we don’t hold people against their will unless there is no alternative," Jennifer Nuzzo, director of the pandemic center at Brown University’s School of Public Health, told The Times.

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'Longevity gene' may protect the brain from Alzheimer's by boosting DNA repair, study finds

A new study suggests that a specific "longevity gene" may help protect the brain from the effects of aging, including Alzheimer’s disease.

The APOE gene (short for apolipoprotein E) helps the body transport and metabolize fats and cholesterol, especially in the brain.

While the APOE4 variant is known to be associated with a significantly higher risk of Alzheimer’s disease, the APOE2 variant of the APOE gene appears to carry a lower risk.

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Using human brain cells derived from stem cells, researchers at the Buck Institute for Research on Aging explored the reasons for that protective effect. They found that the APOE2 gene improves neurons’ ability to repair DNA damage and to resist "cellular senescence," a process that leads to cells becoming old and worn out.

In contrast, brain cells with the APOE4 variant were more fragile and more likely to show signs of aging and dysfunction, the researchers found.

These findings were also supported by follow-up studies in mice.

"We found that APOE2, a gene linked to exceptional longevity (enriched in centenarians), helps human neurons better repair DNA damage and resist becoming senescent, or aged and dysfunctional," senior author Lisa M. Ellerby, PhD, professor at the Buck Institute, told Fox News Digital.

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"APOE has a well-known role in cholesterol transport, but the new mechanism we have discovered may explain in part why APOE2 carriers tend to live longer and have lower Alzheimer’s risk."

The researchers said they were "very surprised" that the protective mechanism of APOE2 in neurons was DNA signaling and repair.

"APOE2 is so well-known for cholesterol transport that uncovering this major pathway, and seeing it hold up across multiple human neuron models and aged mice, was striking for us," Ellerby said.

The study also found that adding the APOE2 protein to APOE4 neurons reduced their DNA damage after the stress of radiation exposure.

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These findings suggest that future treatments could aim to simulate the protective effects of APOE2 or boost DNA repair systems in the brain, especially for people who carry the higher-risk APOE4 gene.

The findings were published in the journal Aging Cell.

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Christopher Weber, PhD, senior director of global scientific initiatives at the Alzheimer’s Association in Chicago, said this is an "exciting and significant study."

"It shifts attention beyond APOE's well-known role in cholesterol transport toward a new function — shaping how brain cells maintain their integrity as they age — and opens up some new directions for therapy development, particularly for people who carry the higher-risk APOE4 variant," Weber, who was not involved in the study, told Fox News Digital.

The Alzheimer’s Association currently has 13 active projects in four countries investigating APOE2’s role in protecting against Alzheimer's disease, he noted.

Caghan Kizil, PhD, an associate professor of neurological sciences at Columbia University Vagelos College of Physicians and Surgeons, recently received a $500,000 grant from the American Brain Foundation to fund research related to the APOE4 gene.

"This study goes beyond the long-known observation that APOE2 is linked to longevity and a lower risk of Alzheimer’s disease and aims to explain why this protection may happen," Kizil, who also did not work on the study, told Fox News Digital.

Kizil agreed that the findings may help explain why some brains stay healthy longer than others, and how natural protective mechanisms may support longer-lasting brain health.

"What I find especially interesting is the idea that Alzheimer’s may partly reflect the brain losing its ability to stay resilient with age," he said. "Growing evidence in the field suggests that APOE-related risk is not only about amyloid buildup, but also about how aging, inflammation, blood vessel health and the brain’s repair systems work together over time."

Future research could explore what makes some brains naturally more resilient, and whether those protective mechanisms could be harnessed to help people who carry higher-risk genes like APOE4, according to Weber. 

"In other words, the long-term goal is to help vulnerable brains age more like resilient brains," he added. "We believe the future of Alzheimer’s research lies in preventing at-risk individuals from becoming diseased in the first place."

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There were some limitations to the new study, the researchers noted – primarily that it was not conducted in living patients.

"Our laboratory study in human iPSC-derived neurons and mice describes a biological mechanism and not a clinical treatment," Ellerby told Fox News Digital. "The precise molecular mechanism by which APOE2 stabilizes the nucleus and supports repair still needs to be fully worked out."

The researcher cautioned that people shouldn't make changes to their lifestyle behaviors based on this study alone, and that they would not recommend undergoing genetic testing for APOE purely for longevity.

"The results are complex and difficult," Ellerby noted. "The broader message is that supporting your brain's DNA repair and slowing cellular senescence are good for you."

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Some healthy ways to accomplish this include exercising, getting optimal sleep, optimizing cardiovascular health and avoiding "genotoxic" exposures like smoking. 

"These are all super beneficial to your health, regardless of your APOE variant," the researcher added.

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Murdoch Children’s Research Institute secures $5M grant to prevent childhood disease

The Murdoch Children’s Research Institute (MCRI) in Australia will receive a $5 million federal grant to launch a pioneering research team for children’s health.

The grant was announced at MCRI’s 40th anniversary gala in Melbourne on Saturday night.

"For 40 years, MCRI has been a global leader in children’s health research," Prime Minister Anthony Albanese told guests at the gala, which was attended by 300 of Australia’s most esteemed medical experts, political leaders, philanthropists and sports luminaries.

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"My government is proud to partner with MCRI, so our world-leading researchers have the best opportunities to support healthier childhoods for Australians now and into the future."

The $5 million will directly support medical research aimed at preventing numerous childhood conditions, including obesity, heart disease, mental health issues and disabilities.

Also announced at the gala, a lead donation from Sarah and Lachlan Murdoch will launch the Horizon Fund — a permanent endowment for MCRI aimed at funding long-term children’s health research and future medical breakthroughs.

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The goal is for the fund to raise between $50 million and $100 million in its first year and to reach $200 million within five years.

The fund is designed to back researchers’ immediate priorities while safeguarding long-term capital for future medical breakthroughs in children’s health.

In 2020, the Murdochs donated $5 million to establish a perpetual fellowship supporting leading researchers in fields including stem cell technology and genomic precision medicine.

Co-founded in 1986 by philanthropist and child health advocate Dame Elisabeth Murdoch and pediatrician and genetics pioneer Professor David Danks, MCRI comprises 1,800 scientists, researchers and clinicians.

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"Dame Elisabeth’s leadership, along with her values, shaped both the direction and the ethos of the Institute we were to become – for all children to live a healthy and fulfilled life," said Sarah Murdoch, who is Dame Elisabeth Murdoch’s granddaughter-in-law and MCRI’s global ambassador and board co-chair. 

"With the generosity of a remarkable group of founding donors alongside the Murdoch family – Sir Jack Brockhoff, the Miller family, and The Scobie and Claire Mackinnon Trust – the foundations were laid for an Institute designed to bring our brightest minds, to serve all children, not only in that moment, but for generations to come," Ms. Murdoch added.

"I see what is possible when foresight, science, commitment, collaboration and heartfelt generosity come together," she emphasized.

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"Because behind every breakthrough is a child — a family desperate for answers. A future changed because of the commitment by so many."

MCRI Director Kathryn North expressed appreciation at the gala to the prime minister for the $5 million grant.

"From the beginning, MCRI has been guided by a simple but powerful purpose: to give all children the opportunity to live a healthy and fulfilled life," North said.

"It reflects a belief that good health is the foundation for a full life, and that opportunity should never be limited by circumstance."

Professor North mentioned the Institute’s focus on developing therapies for previously incurable diseases.

"We are harnessing the power of human stem cell technologies to grow heart patches, functional mini kidneys, blood and immune cells … to better understand disease, and to develop regenerative therapies using a patient’s own stem cells to replace organ transplants and the risk of rejection," she said.

The Institute’s next challenge, North said, is to address chronic conditions like asthma, obesity, allergies and mental health conditions that can persist for decades.

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"These are big problems that will require significant and ongoing support," she said. "Through our work globally, we are helping communities raise their expectations to both deliver and receive the sort of healthcare we take for granted."

"Our ambition now is to translate these partnerships into population-scale solutions that improve the lives of millions of children worldwide," North added. "This is not simply the next chapter for MCRI – it is the work of building the future of children’s health."

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