A.I. could double the human life span in five years. Dario Amadei, CEO of Anthropic, World Economic Forum in Davos, January 2025 (Source).

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This month’s theme: Human clinical trials for longevity. International comparison.

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The development of a new drug or therapy is a long and complex process. Before commercialisation, treatments must go through multiple phases of testing, including clinical trials, which assess their effectiveness, safety, and potential side effects. Clinical trials are essential for making the most innovative treatments accessible to the public or to specific patient groups. The legal frameworks for these trials are evolving rapidly and differ significantly between countries. Almost all human clinical trials are mentioned on the website clinicaltrials.gov.

A human clinical trial is generally divided into 3 phases. Phase 1 proves innocuousness. Phase 2 proves efficiency on a small number of patients. Phase 3 proves efficiency on a large group. Human clinical trials generally follow tests on animals and precede the approval for use in a long and costly process. It is generally considered that the total price for the approval of one new drug is above one billion dollars and that the rate of discoveries is decreasing. This phenomenon is called Eroom’s law. The cost is due to the complicated rules, but also because many attempts to find a drug are failures. 

For longevity-focused research, these legal developments are essential. By harmonizing authorization processes or expanding access to experimental treatments, countries can significantly accelerate progress in various fields such as regenerative medicine and gene therapies. Thus, faster trials would lead to faster access to innovations that prolong and improve life.

United States 

In the United States, Montana has emerged as a hub for various types of clinical trials, including biohacking and experimental treatments. Thanks to a law adopted in 2023, known as the Right to Try, the state now allows experimental treatments to be offered to all types of patients, not just those with terminal illnesses. Before this law, patients needed FDA approval to access investigational drugs that had not yet been formally approved. This rule now allows patients who have exhausted standard treatments to try new therapeutic options. The Right to Try approach is not unique to Montana; it exists in most states. 

In addition, the expansion of the right to try in Montana is attracting companies specializing in biotechnology and longevity. According to some, more than 20 biotechnology companies, particularly those specializing in regenerative medicine and anti-aging, are considering setting up shop in Montana to implement early access programs for patients.

However, it is important to note that the Right to Try only gives companies the opportunity to offer experimental treatments, without creating a legal obligation to do so. Patients cannot demand access to these treatments, and companies remain free to decide whether to offer them free of charge or at a cost.

Europe – European Union

In Europe, since 2022, as part of the « ACT EU » initiative, the Clinical Trial Regulation (CTR) has sought to harmonise clinical trial regulations across EU member states. To achieve this, the Clinical Trials Information System (CTIS) was introduced to centralise applications, simplify international procedures, increase transparency, and speed up approvals. The CTIS serves as a single entry point for clinical trial applications in all member States, replacing the complex set of national procedures that previously slowed down multinational clinical trials. Sponsors can now submit a single application for up to 30 EU/EEA countries at once, reducing delays and administrative work. As a result, since January 31, 2025, all European clinical trials have been following the CTIS system.

All submitted trials must comply with the Good Clinical Practice (GCP) standards to ensure patient safety. 

The administrative approval process takes about 6 to 10 months in the US and approximately 7 months in Europe (210 days). In terms of costs, each phase of the clinical trials in the United States can cost between $1.4 million and over $100 million. The total development of a drug in the US typically costs between $1 billion and $2.6 billion, while in Europe, clinical trials tend to be less expensive overall, with a lower average cost per participant (approximately US$15,000 to US$25,000).

United Kingdom

The United Kingdom, like Europe, aims to re-establish itself as a leading hub for clinical research. Following Brexit, several reforms have been introduced. Starting in 2026, all clinical trials conducted in the country must follow international standards, particularly those of the International Council for Harmonisation (ICH), to ensure global recognition of trial data. Additionally, transparency will be increased: the researchers of every trial will be required to publish a plain-language summary of its results for public access. 

Moreover, the UK is actively investing to become a global leader in clinical innovation. The UK government’s Recovery, Resilience and Growth (RRG) program, which brings together the MHRA, NHS, DHSC, NIHR, regulators, academia, and industry, is establishing a national guide to integrate research into all healthcare systems and reduce trial implementation times. To this end, more than £400 million will be invested to create up to 18 new commercial research centers (CRDCs) across the country, which will promote patient recruitment and strengthen clinical trial infrastructure. The government also plans to reduce the average time to start clinical trials from 250 days to just 10 weeks.

Australia 

Australia is recognised for its high-quality clinical research, supported by robust regulations and internationally recognised standards. Like many leading countries, including the US and EU member states, Australia follows internationally established guidelines such as the Declaration of Helsinki and Good Clinical Practice (GCP) standards set by the ICH, ensuring participant safety, protecting their rights and well-being, and facilitating global recognition of the research. Australia is a leader in early-phase clinical trials, including first-in-human studies. 

In addition, Australia offers several advantages that make it particularly attractive for research in the fields of biotechnology and longevity. The country has one of the fastest regulatory approval systems in the world, with many Phase I trials starting within weeks of submission.

Bahamas 

Clinical research is also active in the Bahamas, particularly for stem cell-based therapies. Unlike in many countries, clinical trials there, regulated by the Bahamas National Stem Cell Ethics Committee, Good Clinical Practice, and local registration, can be funded directly by patients themselves. This model accelerates the pace of the research and provides more flexibility for experimental therapies. 

China 

China has seen a sharp increase in clinical trials and their development in recent years. In fact, by 2023, the number of trials conducted in China had surpassed those in the United States. This acceleration is reflected in the data: that year, China conducted more than 14,000 active clinical trials. 

Since 2015, the Chinese government has implemented several reforms, including its own Good Clinical Practice (GCP) guidelines, to facilitate research and reduce the approval timeline for new drugs to 60 days. These efforts bring China closer to ICH standards, enabling greater participation in international trials and smoother integration of Chinese-developed treatments abroad. 

However, some studies raise concerns about the reliability of Chinese clinical trials, pointing to ongoing quality and ethical challenges in certain areas of research. 

Private zones – The example of Prospera 

In response to highly restrictive regulations, private experimental zones are also emerging. One such example is Prospera, located on Roatán Island in Honduras. Prospera adopts a libertarian approach to clinical research, offering a regulatory framework with shorter approval times and lower costs compared to traditional authorities like the FDA. It is home to several biotech clinics, such as MiniCircle, which conducts gene therapy trials for muscle regeneration and metabolic health. 

However, critics warn of insufficient legal, ethical and patient protection frameworks in these environments. 

Conclusion

The global clinical trial landscape is changing. From Montana’s “Right to Try” laws to harmonized EU regulations, from Australia’s first human studies to China’s rapid expansion, many countries are shaping the speed and safety with which new therapies reach patients. And there are other interesting developments that we will not approach in this newsletter in India, Japan, Mexico, … Considering the importance of the USA and the European Union for the development of new therapies, it is to be hoped that clinical trials will follow good examples of other countries or make approvals of therapies really easy when good clinical trials are made outside of their borders. All other things being equal, going faster saves lives directly and also indirectly by accelerating research/   

For those invested in longevity, understanding these changes is important; it provides insight into the areas where the next breakthroughs will emerge and how quickly they could transform human health and well-being.

To accelerate clinical trials for longevity, we also need more people volunteer for themselves and for the community. We will approach this in one of the next newsletters.

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The good news of the month. ARPA-H Project concerning the brain.

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The ARPA-H (Advanced Research Projects Agency for Health) has launched the FRONT (Functional Repair of Neocortical Tissue) program, which aims to restore brain function in people who have suffered permanent damage to the neocortex. This program aims to regenerate damaged brain tissue by using unspecialized cells transformed into functional cortical tissue to restore lost cognitive functions. This is important and promising concerning Alzheimer’s disease. The goal is to reduce the costs associated with long-term care and improve patient autonomy. ARPA-H is inviting researchers to submit proposals for August-September 2025.

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For more information

• Heales, Longevity Escape Velocity Foundation, International Longevity Alliance, Longecity, and Lifespan.io 
• Heales Monthly Science News
• Heales YouTube channel
• Contact us

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Billionaires often say they’d trade all their wealth to be young again. But most of them don’t invest in aging science. Nathan Cheng, engineer (source).

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This month’s theme: Microplastics and aging

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Microplastics are tiny plastic particles less than 5 millimeters in size that originate from the breakdown of larger plastic waste or are manufactured for use in products like cosmetics and cleaning agents. These particles have become widespread in the environment and have been detected in food, water, air, and even inside the human body, including the lungs, blood, and placenta. Their small size allows them to enter the body through ingestion or inhalation, where they may accumulate and cause harm. Microplastics do not biodegrade and can persist in the environment for hundreds to thousands of years, continuously fragmenting into smaller particles without ever fully disappearing. 

Microplastics can trigger damage, disrupt the gut microbiome, and carry toxic chemicals such as bisphenol A (BPA) and phthalates, which are known to interfere with the endocrine system. Additionally, they may serve as carriers for pathogens and heavy metals, further increasing their potential health risks. While research is ongoing, early studies suggest that microplastics could contribute to immune dysfunction, respiratory issues, hormonal imbalance, and possibly even cancer, making them an emerging threat to human health.

Emerging research suggests that microplastics may contribute to the acceleration of human aging by disrupting several key biological processes. Once inside the body, microplastics can trigger chronic low-grade inflammation, known as “inflammaging,” which is a recognized contributor to age-related diseases such as cardiovascular disorders, neurodegeneration, and cancer. They also promote oxidative stress by increasing the production of reactive oxygen species, leading to damage to DNA, proteins, and lipids, factors closely linked to cellular aging. Furthermore, microplastics have been shown to impair mitochondrial function, reducing cellular energy production and contributing to the decline in tissue function observed with age. In addition, they may induce cellular senescence, a state in which cells stop dividing and begin releasing harmful inflammatory molecules, further accelerating tissue damage. The endocrine-disrupting chemicals carried by microplastics, such as bisphenol A (BPA) and phthalates, can also interfere with hormone regulation, potentially affecting metabolism, reproduction, and other systems tied to the aging process. While further studies are needed to fully understand the long-term impact, current evidence already establishes that microplastic exposure may be a significant environmental factor contributing to premature aging and age-related decline.

Accumulation of Microplastics in Aging Tissues

The accumulation of microplastics (MPs) in aging tissues has become a pressing environmental and biomedical concern. As microplastics become increasingly prevalent in the environment, emerging evidence suggests their systemic uptake and potential to exacerbate aging-related physiological processes, particularly through oxidative stress, cellular senescence, and chronic inflammation. Aging tissues may be particularly vulnerable due to declining barrier functions, impaired clearance mechanisms, and altered immune responses.

Microplastics enter the body principally through ingestion or inhalation. Once internalized, they may: Bypass biological barriers, especially if under 5 µm. Accumulate in organs such as the liver, gut, and even the brain. Generate reactive oxygen species (ROS), which induce oxidative damage. Trigger senescence pathways in fibroblasts and immune cells. Alter extracellular matrix composition (ECM), leading to impaired tissue repair and elasticity.

1. Skin Aging and Fibroblast Senescence

A 2024 study demonstrated that polystyrene microplastics disrupted skin barrier function and induced fibroblast senescence. This led to downregulation of key ECM genes such as COL1A1, contributing to premature skin aging 

2. Systemic Aging and Cognitive Decline in Animal Models

Chronic oral exposure to polyethylene terephthalate (PET) microplastics (MPs) in senescence-prone OXYS rats accelerated features of age-related diseases, such as cataracts, macular degeneration, and memory impairment, suggesting systemic aging effects beyond the site of entry.

3. Environmentally Persistent Free Radicals (EPFRs) from Aged MPs

A critical review highlighted that aged MPs can carry and generate EPFRs, which may further contribute to oxidative stress and toxicity when they accumulate in biological systems 

Effect in the brain

The most worrying effect known today is that microplastics can cross the blood-brain barrier, and they remain in the brain until death. Even worse, a study showed that people with Alzheimer’s disease have higher levels of microplastics in the brain. This doesn’t prove that microplastics aggravate neurodegenerative diseases because neurodegenerative diseases could facilitate the penetration of microplastics. But it is at least worrying.

Synergistic Effects with Other Environmental Pollutants

Microplastics (MPs) are not only toxic in isolation but also serve as vectors for co-pollutants like heavy metals (HMs), persistent organic pollutants (POPs), and pharmaceuticals. In aged populations—characterized by reduced detoxification capacity and compromised gut and immune barriers—the combined toxic burden of MPs and these contaminants may exacerbate health risks such as inflammation, oxidative damage, and organ degeneration.

Microplastics act as sorption (sort of absorption) substrates due to their high surface-area-to-volume ratio and hydrophobicity. Upon aging, especially under UV or thermal exposure, MPs:

• Become rougher and more porous.

• Develop oxygen-containing functional groups that increase affinity for metals and organics.

• Undergo surface oxidation, enhancing adsorption of cadmium (Cd²⁺), chromium (Cr), lead (Pb²⁺), and various endocrine-disrupting chemicals.

Once internalized in the body, these composite particles (MPs + contaminants):

• Induce oxidative stress through reactive oxygen species (ROS).

• Trigger autophagy and pyroptosis (inflammatory cell death).

• Compromise the intestinal and blood-brain barriers, especially in aging tissues.

Conclusion

It is too late to stop microplastics with our current technical and scientific capacities. Plastics are everywhere, and they will continue to degrade in the coming years. We must urgently collect more knowledge about the effects in animal models (mice), and thanks to epidemiological studies. We must urgently study how to mitigate absorption in the body, especially in the brain. 

The only good news is that it seems to have no important negative effect yet. Indeed, life expectancy continues to rise even in places where microplastics are in large quantities. It could be that most microplastics are not very harmful. It could even be that in very specific cases, some microplastics have a few positive consequences (let’s dream, artificial is not always bad). However, as long as we do not study this enough, we take an enormous risk of slowly damaging our bodies from the inside because of the environmental changes we created.

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The good news of the month. A single gene to rejuvenate human cells.

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Shift Bioscience has discovered SB000, a single gene capable of rejuvenating cells without activating pluripotency, avoiding the risks associated with OSKM (Yamanaka factors). SB000 matches OSKM in reversing cellular age while preserving cell identity and function. It works across multiple cell types and enhances functions like collagen production. The discovery was made using an AI-driven platform based on transcriptomic aging clocks.

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For more information

• Heales, Longevity Escape Velocity Foundation, International Longevity Alliance, Longecity, and Lifespan.io 
• Heales Monthly Science News
• Heales YouTube channel
• Contact us

When I started 25 years ago, I would have answered that it is not possible to reverse [ageing], but with the latest advances and everything that is being done with regenerative medicine, stem cells, etc., I believe that it can be reversed in part, right? That we can reverse some things. That is what we have seen in animals. Consuelo Borras, Spanish scientist working in the longevity field, 2025 (source)

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This month’s theme: The effect of hormones on aging

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Hormones are powerful regulators of many essential processes in the body, from metabolism and muscle maintenance to mood, immunity, and bone density. As we age, levels of key hormones such as DHEA, estrogen, testosterone, growth hormone, and cortisol shift significantly. These changes can accelerate physical and cognitive decline, increase the risk of chronic diseases, and reduce overall resilience. However, growing research suggests that by understanding and potentially modulating these hormonal shifts through lifestyle, supplementation, or targeted therapies, we may be able to slow the aging process and support healthier, longer lives.

In this context, several physicians, most notably Dr. Thierry Hertoghe, Dr. Neal Rouzier, and Dr. Abraham Morgentaler, advocate for the use of bioidentical hormones, which are structurally identical to those produced by the human body. Dr. Hertoghe emphasizes personalized hormone replacement to restore youthful levels and prevent age-related decline. Dr. Rouzier promotes a science-based, individualized approach to optimize hormonal balance while minimizing risks. Dr. Morgentaler has challenged long-standing concerns about testosterone, showing that when properly managed, it can enhance metabolic, sexual, and mental health without increasing prostate cancer risk. Collectively, their work supports a proactive, hormone-centered strategy for healthy aging.

To delve deeper into the role of hormones in aging, it is essential to explore specific hormones and their impacts.

What is DHEA?

DHEA (dehydroepiandrosterone) is a natural steroid hormone primarily produced by the adrenal glands. It acts as a precursor to sex hormones, including estrogen and testosterone. DHEA levels peak in early adulthood and decline progressively with age, dropping to 10–20% of peak levels by age 70–80. Low levels are associated with adrenal insufficiency, chronic diseases, acute stress, and anorexia. In the 2010s, some studies suggested that higher circulating DHEA might be linked to longevity and healthy aging. However, the clinical benefits of DHEA supplementation in the elderly remain uncertain and under investigation.

The role of DHEA in health and aging

One area where DHEA shows promise is in supporting women during and after menopause. Studies have found that DHEA supplementation can raise levels of hormones like estradiol and testosterone in postmenopausal women. This hormonal boost may lead to improvements in body composition, mood, energy, and overall well-being, potentially easing the transition through menopause.

Beyond menopause, this hormone may also contribute to healthy aging more broadly. In animal studies, combining it with stem cells derived from human umbilical cords has been shown to reduce inflammation and slow uterine aging in mice. These results point to its potential in anti-aging therapies, especially when used alongside regenerative treatments such as stem cell therapy. In addition to its hormonal role, this compound has neuroprotective properties. Research suggests it may help preserve cognitive function with age and possibly lower the risk of mental decline. It’s also being explored as a biomarker of aging, a biological indicator of how the body is progressing over time.

Bone health is another area where it shows promise. Both the original molecule and its sulfate form, DHEAS, have been associated with greater bone density and a reduced risk of fractures in older adults. These findings suggest it could help prevent osteoporosis and maintain skeletal strength as we age.

This hormone plays a role in regulating the immune system by modulating both innate and adaptive responses. It also helps manage the body’s reaction to stress by interacting with cortisol, the main stress hormone. The balance between the two is believed to be vital for maintaining both physical and mental well-being, especially in situations of prolonged stress.

Clinical trials show that some supplements, including DHEA, can raise testosterone and estradiol in a dose-dependent way, meaning that hormone levels increase proportionally with the administered dose. However, many studies use low doses, possibly limiting observed benefits like improved muscle mass, bone density, and cognition. Doses over 50 mg/day of DHEA increase testosterone more effectively, but may also raise estrogen levels.

Research shows that DHEA has variable effects on cancer (positive or negative) depending on the type and context.

Growth Hormone, IGF-I, and aging 

Growth hormone (GH) and its mediator insulin-like growth factor 1 (IGF-1) decline with age, contributing to reduced muscle mass, bone density, and quality of life in the elderly. Regular physical exercise can stimulate the GH/IGF-1 axis, supporting healthier ageing and improved physical function. However, overactivation of this pathway may increase the risk of certain chronic diseases over time. In animal models, exercise has been shown to preserve muscle function by positively modulating this hormonal system, delaying muscular ageing. Paradoxically, GH deficiency can lead to delayed aging and increased healthspan in several mammalian species, where adult body size (GH-dependent) negatively correlates with longevity. While GH receptor knockout (GHR-KO) mice are the longest-lived laboratory mice known, this longevity effect does not extend to humans with GH deficiency or resistance, although they exhibit reduced age-related disease and improved healthspan. Notably, GHR gene inactivation also reveals sex-specific differences in longevity and metabolism.

Hormonal and nutritional factors in diseases and aging

Several hormonal and nutritional changes associated with aging contribute to the progressive decline in muscle mass and function known as sarcopenia, as well as to broader musculoskeletal, metabolic, and cognitive impairments. IGF-1 levels decrease with age, reducing muscle anabolism, bone density, and metabolic efficiency. In men, testosterone decline is linked to losses in both muscle mass and strength, while in women, estrogen deficiency after menopause also negatively affects muscle and bone, which could lead to osteoporosis. Other endocrine factors, such as DHEA, which also declines with age, may play a role in sarcopenia due to its anti-inflammatory and antioxidant properties. However, its precise impact remains under investigation. Thyroid hormone imbalances may also affect muscle metabolism, although their exact role in sarcopenia remains unclear.

In addition to hormones, micronutrients are crucial for maintaining physiological function with age. The interplay between declining hormone levels and nutrient deficiencies increases vulnerability to age-related disorders. While hormonal and dietary interventions may help slow these effects, they should be individually tailored and medically supervised.

Cortisol, exercise, sleep, and aging

Cortisol, a hormone regulated by the hypothalamic-pituitary-adrenal (HPA) axis, plays a central role in the body’s stress response and aging. Elevation of cortisol in older adults is linked to cellular aging and increased inflammation, which contribute to metabolic and cognitive decline. An imbalance marked by high cortisol and low DHEA is associated with greater risks of sarcopenia, obesity, neurodegeneration, and immune dysfunction.

Importantly, regular physical activity improves cortisol regulation by reducing HPA axis hyperactivity, a common feature of aging. Six months of aerobic training has been shown to enhance the cortisol awakening response in older adults, and those who exercise most show biological aging markers nearly nine years younger than their sedentary peers.

Sleep quality, often compromised with age, is closely tied to cortisol dynamics. Poor sleep increases cortisol levels and the risk of sarcopenia, while adequate sleep buffers diurnal cortisol elevation and improves hormonal balance. Physical exercise also enhances sleep, reinforcing this beneficial cycle.

Together, exercise and good sleep hygiene contribute to more effective cortisol regulation, offering protective effects against multiple age-related conditions and slowing aspects of biological aging.

Bioidentical hormones

Chemically identical to human hormones, bioidentical hormones are used in hormone replacement therapy (HRT) to address age-related declines. Derived from plants, they are tailored to individual needs and can alleviate menopausal symptoms like hot flashes and mood swings. These hormones may also improve bone density, cognitive function, and cardiovascular health, potentially slowing aging. However, their long-term effects on aging and longevity are still under investigation, with mixed findings on safety and efficacy.

Conclusion
Hormonal changes with age, such as declines in IGF-1, sex hormones, vitamin D, and imbalances in cortisol, contribute to many age-related disorders. Regular physical activity, a balanced diet, and good sleep help regulate these hormones, supporting healthier aging. Monitoring and addressing these changes can promote better function and quality of life in older adults. Additionally, emerging research on hormones like DHEA shows potential benefits for menopausal women, bone health, and cognitive function, though its effects on cancer vary and require further investigation. While these hormones play an important role in the mechanisms of aging, and even if some “anti-aging doctors” propose those therapies, no definitive evidence has yet shown that they can increase lifespan.

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The good news of the month : Big Strides in Longevity: $101M XPRIZE Race. CRISPR Baby

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The $101 million XPRIZE Healthspan competition has named 40 semifinalists worldwide. These teams aim to reverse aging by at least 10 years in key functions like strength, cognition, and immunity in just one year of treatment. Winners will receive major funding to bring their therapies to life

A groundbreaking milestone in gene therapy has just been reached: a 9-month-old boy named KJ is the first person to receive a personalized CRISPR treatment, designed to fix a rare and deadly genetic liver disorder (CPS1 deficiency). The therapy was delivered directly to his liver cells with promising early results. This therapy was developed at the Children’s Hospital of Philadelphia in only a few months (including tests on mice and on monkeys)!

For more information

• Heales, Longevity Escape Velocity Foundation, International Longevity Alliance, Longecity, and Lifespan.io 
• Heales Monthly Science News
• Heales YouTube channel
• Image
• Contact us

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Age reversal works in primates to restore vision. Next up: age reversal in humans.

-David Sinclair (see also Good News of the Month below). Source.

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This month’s theme: Questions related to the sharing of health data for longevity

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Introduction

We have decades of health data for billions of people. We have also data on smartphones and wearables about the activities of hundreds of millions of citizens. We could potentially see almost in real time what of are the effects of all the drugs used in many countries to cure and prevent diseases related to old age. We could see the effects of drugs combined, constant if new diseases appear or on the contrary, if patients are going better, see if people have more or less physical activities.

However, for this to be possible, we need not only data but data that we can access. At the moment, we have situations where we overuse some data and do not use most other data. The principal obstacles are questions related to privacy, private interests to keep data available only to a few, and curation. In this newsletter, we will not approach questions related to the “property” of data.

Questions related to privacy.

There are two main ways to respect privacy before sharing health data: anonymization and pseudonymization.

Anonymization is the process of removing or altering personal or identifiable information from data so that the individuals to whom the data pertains cannot be readily identified. In simpler terms, it’s a way to hide someone’s identity in a dataset. In this process, theoretically, there is no way back, once the data is anonymized, one cannot anymore know who was the person with the information.

Pseudonymization is the technique used to replace or encrypt personally identifiable information in data with artificial identifiers, or pseudonyms. These pseudonyms allow the data to be used for analysis or other purposes while still protecting the identity of the individuals involved. It’s like giving each person in a dataset a fake name or code to protect their real identity. In this process, theoretically, you can find the information back (by replacing again the pseudonyms with the real names).

Anonymization is better for privacy but less good for research. Because for research, sometimes you need to find out more about the subjects of the experiment after the experiment is started. And anonymization makes it impossible to find more.

Of course, in any situation, it is also important to remember concerning privacy for health data that:

• It must be prohibited for researchers to use data for other goals than for research.
• Access to data has to be registered and kept for a long period so that potential users know they risk being in trouble for an illegitimate use even if this misuse is detected after a long time.

Curation

Health data curation refers to selecting, organizing, and managing health-related data to ensure its accuracy, relevance, and accessibility for healthcare professionals and researchers. Health data curation aims to improve the quality and usefulness of health data for analysis, research, diagnosis, treatment, and public health initiatives. We need institutions like Data Curation Centres (DCC)

Here are some examples of data curation in action:

• Data Acquisition: This phase entails the careful selection and procurement of data from a multitude of origins, spanning databases, online platforms, and other digital repositories and from a multitude of sorts: electronic health records, medical imaging, clinical trials, and wearable devices. It also involves vetting the data to ensure its reliability and suitability for the intended purpose. 
• Data Cleansing and Transformation: This step focuses on purging and reshaping data to enhance its utility. It involves eliminating redundant entries, rectifying inaccuracies, and standardizing data formats to facilitate analysis. 
• Data Organization: Data has to be methodically arranged into logical groupings, be it by chronological order, classification, or source attribution. Such an organization streamlines data retrieval, utilization, and analysis. 
• Data Accessibility: Making data readily accessible to users is paramount. This can be achieved through user-friendly interfaces, web-based tools, or Application Programming Interfaces (APIs), enabling seamless data retrieval and exploration. 
• Data Preservation: Ensuring data longevity involves regular backups, archival procedures, and stringent security measures to safeguard against unauthorized access or loss. 

Synthetic Data: A solution for privacy? 

Synthetic data is information that is artificially manufactured and not generated by real-world events. It could be a solution to avoid privacy questions and permit better health research. However:

• Since health synthetic data is generated based on real data, some specialists consider that they still can be considered personal data.
• Since synthetic health data is generated based on already known information and hypotheses, it can be that it is not showing what real health data will show (synthetic data will not include “surprising” data).

EHDS

The European Health Data Space (EHDS) is a specialized ecosystem designed to enhance the management of health data within the European Union. It encompasses regulations, standard practices, infrastructure, and governance to achieve several key objectives: 

• Empowering individuals by granting them greater digital access to and control over their health data, both nationally and across the EU. 
• Cultivating a unified solution for electronic health record systems, pertinent medical devices, and high-risk AI systems. 
• Establishing a reliable and efficient framework for utilizing health data in research, innovation, policy-making, and regulatory activities (known as secondary data use). 

EHDS stands as a crucial component of the broader European Health Union initiative. It builds upon existing regulations such as the General Data Protection Regulation (GDPR). The goal is to strengthen the European Health Union, ensuring that member states are equipped to address health crises effectively, have access to affordable and innovative medical resources, and collaborate to enhance disease prevention, treatment, and post-care.

Examples of how the EHDS will function

Example 1: A woman living in Portugal is going on holiday to France. She gets sick in France and needs to see a local general practitioner. Thanks to the EHDS and MyHealth@EU, a doctor in France will see on his/her computer the medical history of this patient in French. The doctor can prescribe the necessary medicine based on the medical history of the patient, avoiding for instance products to which the patient is allergic.

Example 2: A health tech company is developing a new AI-based medical decision support tool that assists doctors in making diagnostic and treatment decisions following a review of the patient’s laboratory images. The AI compares the patient’s images with those of many other previous patients. Through the EHDS, the company can have efficient and secure access to a large number of medical images to train the AI algorithm and optimize its accuracy and effectiveness before seeking market approval.

Health Data Hub example

France possesses a substantial and well-structured data repository, which presents an international competitive advantage for research and innovation. However, accessing this data for projects of public interest has historically posed significant challenges. 

In response to these challenges, the Health Data Hub was established as a public entity. Its primary goal is to facilitate access for project coordinators to non-identifiable data hosted on a secure platform, in full compliance with regulations and citizens’ rights. This platform enables the cross-referencing and analysis of data to enhance the quality of care and patient support.

Conclusion

Some perspectivists say “Data is the new oil“. We could also say “Health Data is the new penicillin” (or even more than that). Contrary to oil, (curated) health data are complicated to use not because of natural obstacles, but because of a lack of goodwill and good laws to share it, Contrary to oil, the more we use (curated) health data, the more it can be useful. It could become a precious common good. 

Health Data is one of the keys to healthy longevity. We need it to measure progress, to understand health dangers (pollution, new diseases…), to accomplish clinical trials, and to make us more human.

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The good news of the month: Gene therapies and rejuvenation.

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Californian researchers declared that gene therapy-mediated partial reprogramming extends lifespan in aged  (wild-type) mice. And the progress announced is important (even if only about the remaining lifespan of already quite old mice). The inducible OSK system, in those 2 old years male mice extends the median remaining lifespan by 109% over wild-type controls. 

The abbreviation OSK is used for the expression of three Yamanaka factors, Oct4, Sox2, and Klf4.

Life Biosciences (Life Bio) and David Sinclair announced tests in nonhuman primates with a new gene therapy that uses a partial epigenetic reprogramming approach to restore visual function. It is affirmed that when eyes were treated with OSK after laser damage, it significantly restored pERG responses compared to controls, consistent with restoration of vision. This is very promising even if It was not tested in old (sick) primates but on healthy subjects.

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For more information

• Heales, Longevity Escape Velocity Foundation, International Longevity Alliance, Longecity, and Lifespan.io 
• Heales Monthly Science News
• Heales YouTube channel
• Contact us