One of the early signals to watch comes from PhaseV, which used the opening of the meeting to introduce its new AI-powered Enrollment Lab. The launch reflects a broader shift visible across SCOPE this year. Sponsors and CROs are moving upstream, earlier in the development lifecycle, to replace assumption-driven planning with evidence-grounded decision-making.

Enrollment remains one of the most persistent causes of trial delay. Protocols are often finalized before teams fully understand how inclusion and exclusion criteria interact with real world patient availability or with competitive trial pressure. PhaseV’s Enrollment Lab is designed to address that gap by allowing study teams to quantify true enrollment potential before protocol lock, not after sites have already struggled.

Built as a high impact extension of the PhaseV ClinOps platform, the Enrollment Lab leverages real world EHR data to model patient eligibility alongside patient level competition. Instead of relying on theoretical projections or late stage site surveys, sponsors can explore how specific protocol trade offs affect enrollment volume in real time. Small design decisions become visible for what they are, either barriers to access or opportunities to expand reach.

Raviv Pryluk, PhD, CEO and co-founder of PhaseV, described the intent as a shift from planning on paper to planning in clinical reality. By uncovering constraints early, teams can stress test their designs and ensure that studies are grounded in a verified patient population before site identification begins. That change in timing matters. It moves feasibility from a reactive step to a strategic one.

From a technical perspective, the Enrollment Lab extends PhaseV’s population first approach. Elad Berkman, CTO and co founder, emphasized the ability to translate protocol choices and competitive pressure into a clear view of real patient access. This precision guided modeling allows teams to evaluate alternative inclusion criteria, identify lightly contested patient segments, and surface geographic regions that may be overlooked by traditional planning methods.

Positioned early in the workflow, the Enrollment Lab establishes what is realistically achievable before resources are committed downstream. Once realistic enrollment potential is defined, PhaseV’s site identification tools can then prioritize investigators based on their ability to deliver against that plan rather than aspirational targets. The result is tighter alignment between protocol design, site selection, and execution.

As conversations continue throughout SCOPE, this launch is likely to gain strong traction among sponsors focused on shortening timelines without compromising scientific rigor. The message aligns with what many leaders here are emphasizing. Faster trials do not come from pushing sites harder. They come from designing studies that reflect how patients actually exist within health systems.

PhaseV is demonstrating the Enrollment Lab throughout the Summit, offering attendees a closer look at how real world data can be applied before the first site is ever activated. For an industry increasingly focused on predictability and patient centricity, this announcement sets an early tone for the news still to come out of SCOPE in the days ahead.

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When I read stories that appear throughout the book, the room becomes pin-drop silent. Not uncomfortable, but attentive. People lean forward. Some close their eyes. Others quietly wipe away tears. Even after reading these stories again and again, my own eyes still mist. These are not reactions to theory or argument. They are responses to a painful reality many recognize.

What becomes clear in those rooms is that the frustration is not isolated to one role or perspective. Patients speak about waiting and uncertainty. Clinicians describe exhaustion and moral strain. Innovators and policymakers wrestle with systems that move more slowly than the problems they are trying to solve. The details differ, but the throughline is the same: people want care that recognizes their presence and treats them as more than a process to be managed. When that recognition happens, the tone of the conversation changes.

Since its listing, the book has spent several consecutive weeks on Amazon’s Top New Releases list. That matters in a conventional sense. Still, rankings, whether in print or digital format, do not explain what happens when people hear their own experience reflected back to them with clarity and respect. Stories do that work. Many are weary of facts and figures deployed to justify positions rather than illuminate lived reality.

Human experience carries a different kind of truth. It does not compete with data, but it precedes it. When experience is named accurately, people do not feel persuaded. They feel recognized. That recognition opens space for reflection, dialogue, and ultimately for change.

A Question That Changes the Room

I finished a book talk and signing with The Marfan Foundation, and the impact lingers beyond the formal program. During the signing, people ask thoughtful, personal questions. I often ask permission to respond by reading a short passage from the book. Then I listen to stories of courage, love, and endurance that surface naturally and without prompting.

Parents speak about children. Siblings talk about one another. Families describe navigating medical uncertainty and emotional trauma over years, sometimes decades. Individuals share how they discover the strength they did not know they possessed, and how they learn to share that strength with others walking similar paths. These are not stories of abstraction. They are lived, detailed, and deeply human.

The Marfan Foundation is one of the patient and professional communities reflected in the book, and in the room, the reason is unmistakable. Physicians are spoken of by first name – Alan, Duke, Kim and Reed – not title. They are described not as distant experts, but as people who show up consistently and with care. These stories remind everyone present that even in the most complex conditions, care is sustained by relationships as much as by scientific excellence.

Between Two Meetings, on a Moving Train

As I board a Brightline train for the next meeting, the contrast stays with me in a quiet, persistent way. I am traveling from a gathering centered on shared human experience to SCOPE Summit 2026, a global convening focused on clinical trials and research infrastructure. The agenda centers on development planning, protocol optimization, patient-centric trial design, site engagement and recruitment, generative AI, and the technologies that move science from hypothesis to evidence.

One meeting is rooted in lived journeys, where science is received as hope amid uncertainty. The other is grounded in structure and precision, where science is designed, measured, and scaled. Both spaces matter deeply, and both are essential to progress. Clinical research is where rigor lives and where uncertainty is reduced in ways that allow care to advance responsibly.

Yet the transition between these two gatherings and two cities reveals something essential. People do not leave their humanity at the door of the operating room or the halls of science. They carry it with them into protocols, endpoints, enrollment decisions and trial participation. Patients do not experience trials as abstractions. They experience them as acts of trust layered onto already complex lives.

When Structure Forgets Experience

Too often, human experience is treated as something to be accounted for after systems are built, rather than as a foundation for their design. Trials are optimized for efficiency and compliance, yet struggle when recruitment falters, participation drops, or trust erodes. These outcomes are not solely technical failures. They are relational failures.

Patient-centric trial design is not a feature added late in development. It is a mindset that shapes questions, assumptions, and priorities from the start. Site engagement is not a procedural step, but a relationship built over time. Technology reduces burden only when shaped by empathy, context, and understanding.

Rare disease communities such as The Marfan Foundation understand this instinctively. When systems fall short, patients and families organize, advocate, and collaborate more intentionally. In doing so, they model what the broader system aspires to scale: trust, continuity, shared language, and partnership. People do not fragment their lives the way systems fragment care.

When Experience Finally Counts

At SCOPE, this question becomes practical rather than theoretical. I moderate a fireside chat with StuffThatWorks executives Yael Elish and newly appointed CEO Julie Ross, exploring what happens when patient experience is treated not as a marginal input but as the foundation of artificial intelligence itself. Billions of dollars are invested in pre-clinical discovery, yet clinical trials remain a costly bottleneck, often stretching beyond seven years before therapies reach patients.

One story from the book captures why this matters. A woman living with a chronic autoimmune condition follows treatment guidelines faithfully yet struggles with side effects that force her to stop therapy repeatedly. Her medical record reflects non-adherence, not struggle. It is only when she joins a patient-driven community where thousands share lived experience that patterns emerge her clinicians have never seen.

Within weeks, she learns how others adjust dosing, manage side effects, and balance treatment with daily life. When these experiences are aggregated and analyzed, they do not contradict clinical science. They complete it. What once looks like noise becomes a signal when the human story is allowed to remain intact.

This is why patient-derived models matter. Real-world evidence is not simply post-market surveillance. It is the accumulated story of how people actually live with disease, navigate treatment, and make trade-offs that controlled environments rarely capture. These data are not neutral artifacts. They are lives rendered into patterns with meaning.

Restoring What Was Lost

What I witness in quiet rooms, at signing tables, and in conversations that follow readings is not resistance to science. I see the same truth as a fireside chat moderator, alongside people dedicated to bridging patient voice, data, and science in ways that honor those it seeks to serve. What emerges, again and again, is a longing for connection.

People are not asking to be spared complexity, nor do they believe science belongs only in a sterile laboratory. They are asking not to be erased by it. They want science that recognizes them even as it advances, and systems that remember who they are designed to serve.

This is where Why People Matter ultimately resides. Healing does not begin when systems are optimized or when data moves faster. It starts when relationships are restored and when people feel recognized within the structures meant to help them. Science advances when trust is present, and trust grows when listening is treated not as an accessory but as a foundation.

If there is a path forward, it is not found by choosing between humanity and innovation. It is found by refusing to separate them. Data matters because people do. And when science remembers that progress becomes worthy of the lives it touches.

The post Why Healing Still Begins with Relationship appeared first on Medika Life.

For too long, “AI” has been the abbreviation for “artificial intelligence.”  Reject that label!  It’s not only limiting – it’s incorrect.  The information gathered and parsed comes from real-world sources – patients, payers, product innovators, policymakers, and providers.  It is composite data, once called “big data,” sliced and diced through machine learning and then applied to good, sometimes life-sustaining use.  It’s time we acknowledge how “AI” has become a practical source for talent and organizational enhancement.

Health Enters the Age of “Augmented Implementation”

Here’s a dive into 10 transformative examples of how “AI” enables people to tap into their significant potential to heal and accelerate care delivery.  Change is always hard, even when the advantages appear evident, as it requires revamping processes and policies.  However, as innovation theorist, AI philosopher and Nosta Lab Founder John Nosta reflects: “Culture crushes innovation.” 

Nosta shares with Medika Life readers: “AI, particularly through large language models (LLMs), is revolutionizing healthcare by fostering ‘learner-centricity.’ This approach places physicians, patients, and healthcare systems at the center of a dynamic, personalized learning process. LLMs provide tailored, context-specific knowledge, enabling real-time insights and deeper understanding. Whether it’s a clinician refining diagnostic skills or a patient comprehending treatment options, LLMs create a collaborative learning ecosystem. This synergy enhances the healthcare experience, empowering all participants through shared knowledge and continuous growth.”

The culture of medicine is storied and slow-moving. Still, these 10 approaches to weaving AI into the health system are piquing people’s priorities and enthusiasm for greater use. The wave of universal acceptance is underway.

1. Revolutionizing Patient-Clinician Interaction

Ambient Listening Technologies (ALTs) are modernizing how clinicians transcribe medical documents – by capturing, recording, managing, and analyzing audio data from the patient exam room. AI transcription tools like the Nuance Dragon Ambient eXperience (DAX) from Microsoft streamline recording tasks that once consumed chunks of a clinician’s day. AI-driven transcription systems record and summarize patient-clinician conversations, enabling providers to focus on patients rather than documentation. The plus for doctors is reduced admin time; for patients, it provides the benefit of ensuring their provider has real-time notes for follow-up care delivery.

2. AI-Enhanced Diagnostics are Challenging the Future of Illness

Technologies like DeepMind AlphaFold provide unprecedented insights into protein structure prediction, accelerating drug discovery and enhancing diagnostic tools for diseases like Alzheimer’s and certain cancers. Anyone tracking the field of AI-empowered diagnostics would do well to keep a close eye on innovation in this space.  The 2024 Chemistry Nobel Prize was awarded to John Jumper, PhD, and Demis Hassabis, PhD, at Google DeepMind in London for developing this game-changing AI tool for predicting protein structures.  The Galien Foundation Prix Galien is often called the Nobel Prize of the Life Science industry.  Viz.ai, a pioneer in AI-powered disease detection and intelligent care coordination, received the 2024 Prix Galien USA Award for its Viz HCM™ (Hypertrophic Cardiomyopathy) module.  Keep an eye on these companies and their advances.

Rob Havasy, HIMSS Senior Director of Informatics Strategy, representing one of the most influence professional communities – the leaders from health institutions and governments worldwide – offered this exclusive comment to Medika Life:

“AI has been part of many radiology workflows for years, but data from our HIMSS Market Insights surveys show one of the fastest growing applications right now is ambient AI and other AI tools to relieve some of clinicians’ documentation burden. These tools either help clinicians capture information from a visit or streamline patient-provider communications by creating discharge instructions or helping to manage overflowing inboxes.”

3. Accelerating Drug Discovery and Clinical Trials

AI is catalyzing innovation in drug development, a process that traditionally spans over a decade. Platforms like Hong Kong-headquartered Insilico Medicine and companies like Exscientia are applying machine learning to design drug molecules faster than ever. Meanwhile, decentralized trials are becoming more accessible through collaborative pathways set by organizations such as the Decentralized Trials & Research Alliance (DTRA), a central gathering point for regulators and industry leaders to shift the conversation from theoretical to operational regarding implementation.

Dr. Amir Kalali and Craig Lipset, pioneers in clinical trial innovation, champion this collaborative model that draws in biopharma-sector leaders, CROs, and FDA and EMA regulators. The DTRA Co-Chairs have long advocated that decentralized clinical trials (DCTs) supported by AI tools broaden access and reduce biases. These collaborations demonstrate how AI unlocks new efficiencies and enables more inclusive participation, particularly among underrepresented populations.

4. Predictive Analytics for Patient Safety

Predictive analytics powered by AI is transforming patient safety in hospitals. For example, Qventus predicts and mitigates perioperative complications. At the same time, companies like Stasis Labs, Current Health, and Vytrac provide real-time in-patient and at-home monitoring, sending vital sign data to nurses and doctors so they know their patient status and triage care.  Amy Abernathy, MD, PhD, has served in several high-profile roles that cut across the health ecosystem, from Principal Deputy Commissioner at the Food and Drug Administration (FDA) and is now Co-Founder of Highlander Health, a bold new organization advancing clinical research and patient care through learning labs, investments, and philanthropy, comments: “AI is transforming how we approach patient safety by intervening in a proactive measure rather than a reactive one.”

5. Addressing Mental Health Needs with AI

Mental health care is becoming more accessible with AI-driven platforms such as Woebot Health and Wysa. These companies are using AI to provide scalable, CBT-based support for conditions like anxiety and depression, often meeting the needs of underserved populations without ready access to mental health services. Another approach led by GrayMatters Health enables mental health professionals to address PTSD through neuromodulation – an FDA-approved for-use approach designed through years of data aggregation.  Noted digital health pioneer, inventor, and  Founder and Curator for NextMed Health, Daniel Kraft, MD, notes: “AI-powered mental health tools are filling the gaps in traditional care delivery, providing immediate, accessible, and empathetic support when people need it most.”

6. Driving Precision Medicine

Precision medicine, enabled by AI, is bringing targeted therapies into sharper focus. Collaborating with Roche, Foundation Medicine uses genomic profiling to guide cancer treatments. Similarly, Tempus leverages AI to connect molecular and clinical data, accelerating therapeutic breakthroughs. The combination of high tech with high science has enabled scientists with support from private equity and academic institutions worldwide to create companies at the vanguard of the discipline in the UK Golden Triangle, Southeast Asia, and the Cambridge/Boston innovation hub. LABIOTECH author Willow Shah-Neville wrote a concise report of 12 biotech unicorns rated in order of their valuations according to CB Insights. It is worth examining how these fast-moving innovators apply information technology to augment their scientific implementation.

7. Streamlining Hospital Operations

AI tools enhance hospital operations, optimize workflows, and improve patient outcomes. For instance, GE Healthcare Command Centers use predictive analytics to manage patient flow. Other companies, such as LeanTaaS, with its iQueue platform, improve operating room and infusion suite scheduling. Hyro is a much-watched hospital workflow optimizer with services that cut across administrative and clinical departments and add AI to Epic workflows, improving access to care. Edward Marx, a global healthcare consultant and former Cleveland Clinic CIO, emphasizes: “Operational AI is reshaping how hospitals function, eliminating inefficiencies and ensuring resources are used where they’re needed most.”

“Top Trends in Healthcare and Life Sciences” Microsoft video episode titled “The power of information to improve healthcare,” Gil Bashe, Chair of Global Health and Purpose at FINN Partners and Medika Life Editor-in-Chief, joins Tom Lawry, formerly National Director for Artificial Intelligence Health and Life Sciences at Microsoft and now Founder of the AI consultancy Second Century, talk about the opportunities and obstacles in health, AI, and the power of information.

8. Promoting Health Equity Through AI

Medtronic AI-enabled remote monitoring devices are helping bridge the care gap in underserved areas. Similarly, PathAI, in collaboration with Quest Diagnostics, is leveraging “machine learning to improve diagnostics in resource-limited settings, ensuring equitable access to healthcare.  Michelle Longmire, MD, a Stanford-trained dermatologist and founder and CEO of Medable, which offers the research-based biopharma industry an array of research tools with a unified platform, adds: “AI’s potential lies in its scalability, which can extend high-quality care to populations previously overlooked by traditional systems.”

9. Harnessing AI for Population Health

AI is transforming public health by integrating social determinants of health into predictive models. Companies like Epic Health Research Network and Innovaccer are helping health systems anticipate and address population health challenges more effectively. Michael Rosenblatt, MD, with his storied career as a scientist and teacher, having served as Chief Medical Officer at Merck and Flagship Pioneering and now as Co-Chair of the Galien Foundation, notes: “AI-driven insights empower health systems to deploy resources strategically, reducing disparities and improving outcomes across entire communities.”

10. Empowering Patients with Wearables and Digital Health Platforms

Wearables like the Apple Watch have popularized health tracking. Still, more specialized solutions, such as AliveCor and Biobeat are examples of advanced monitors delivering medical-grade heart data enabling patients to access, manage, and share their data and connect with their physicians. Additionally, platforms like the Belong.Life Dave AI focuses on cancer care by guiding patients with tailored recommendations, educational content, and peer support.  David E. Albert, MD, Oklahoma native, physician, inventor, and serial entrepreneur, is the founder of AliveCor and a long-time AI champion, says, “AI will play a role in reducing data into manageable and actionable information for clinical decision-making.”

Looking Forward: A Future Shaped by Collaboration

AI progress in health settings during the past five years illustrates what’s possible when technology meets the demands of patient care, equity, and innovation.  

Is “AI” still threatening and misunderstood?  Absolutely! The term “artificial intelligence” is a threatening misrepresentation of the idea that people will become secondary to machines processing vast amounts of data (largely) accurately and in a blink. However, technology is continuously called upon to automate repetitive tasks.  It does not alone transform people’s health or the fractured health ecosystem – instead, it’s the human desire to question, collaborate, and generate shared – augmented – wisdom that is core to implementation.  

“Driving measurable value at scale with AI is less about the right technology and more about the right leadership. Is there a sufficient level of AI understanding at all levels of the organization?  Is your culture change-ready or change-resistant,” reflects Tom Lawry, principal of Second Century.  Is AI part of your HR plan? In the end, AI success cannot be delegated. Leadership is the catalyst for unlocking its true potential. This requires vision, strategic alignment, and a commitment to empowering teams to innovate and execute with purpose.”

As more people dip their toes into the tech waters, comfort levels are increasing rapidly. Remember the 15-year time gap between Apple’s failed Newton and the early iPhones? Once the idea of a smartphone caught on, it became a personal must. According to a Pew Research Center Survey conducted May 19 to Sept. 5, 2023, 90% of US adults say they have a smartphone. Soon, AI will be ubiquitous in most health settings.

Say so long to artificial intelligence. Welcome to the age of Augmented Implementation!

The next five years promise even more significant advances, , a thirst to use information to accelerate decision-making, fueled by curiosity and collaborations across sectors and the drive to improve lives globally.

The post AI is Transforming Health Delivery: A Five-Year Reflection appeared first on Medika Life.

Scientific Progress for Patients and a Category

At the core of the ReMMi-D trial was the evaluation of CT-132, a prescription digital therapeutic, for the preventive treatment of episodic migraine. The study included 568 participants and was designed with the scientific rigor traditionally associated with pharmacological interventions. The results were compelling: patients using CT-132 experienced a reduction during three-monthly migraine days by the end of the 12-week treatment, a key metric in migraine management.

More than reducing the frequency of migraines, CT-132 showed improvements in patient-reported outcomes related to quality of life and disability, such as the Migraine-Specific Quality-of-Life Questionnaire and the Migraine Disability Assessment. These metrics matter because migraine is a neurological condition that disrupts life activities, affecting employment and social relationships. For the millions of people who have unpredictable and disabling migraines, improvement can have profound quality of life.

According to a statement by Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics:“Click has developed and evaluated a first-in-class digital migraine preventive therapeutic, CT-132, in 2 separate clinical studies to demonstrate a reduction in monthly migraine days, the gold standard measure. We look forward to advancing our FDA Breakthrough Designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care.”

Building on Existing Treatment Possibilities

Migraine remains one of the most debilitating neurological conditions, affecting more than 37 million Americans. Despite pharmacological treatment advances, many people still find their lives shaped by frequent, unexpected, debilitating episodes. Existing medications can be effective, yet they don’t work for everyone and at every instance.  Some patients struggle with adherence, side effects, or simply the anxiety around consistent relief.

CT-132 holds the potential for a new kind of intervention. Delivered by a smartphone, this digital therapeutic is designed to work alongside patients’ existing medications, augmenting their current treatments rather than replacing them. Notably, the trial was designed to evaluate CT-132 in patients already using standard migraine medications. Data from the trial points to the efficacy of CT-132 as a stand-alone intervention and suggests an additive benefit when combined with existing FDA-approved pharmacological treatments.

This approach is key to conditions like migraine, where no single treatment is universally effective. For many people, managing migraine calls for a combination of therapies—some interventional, others pharmacological, and still some behavioral. CT-132’s success demonstrates that digital therapeutics have the potential to be additive to that combination, helping people regain control over their condition.

A Potential Step Forward for Digital Health

The results of this trial are even more noteworthy for an entire sector because CT-132 is one of the first digital therapeutics to be evaluated with the same rigorous standards typically applied to pharmaceutical interventions. The randomized, double-masked, controlled study design is a gold standard in clinical research, and Click Therapeutics has brought that level of precision to the digital health category.

Stan Kachnowski, PhD, MPA, founder of HITLAB and a prominent figure in health informatics, has also echoed the importance of this transformation, stating previously that “The convergence of digital therapeutics and traditional healthcare is one of the most promising avenues for improving patient outcomes. Clinical data helps substantiate the effectiveness of digital interventions, paving the way for broader adoption in complex diseases like migraine.”

Digital health has often been touted for its innovation and potential, but the field has faced great skepticism around its ability to deliver scientifically proven results. The CT-132 trial is an answer to those on the sidelines, demonstrating how digital therapeutics—with ample clinical data—can improve people’s outcomes. The nearly 100% completion rate of daily tasks in the trial speaks to the potential for sustained patient engagement, an essential factor in the long-term success of any therapeutic intervention.

Recent FDA guidance on Prescription Drug Use-Related Software (PDURS) opens the door to a new treatment category combining digital and pharmacological interventions. The data from CT-132 adds weight to this model, opening the wide door to showing how digital therapeutics can support existing treatments and may offer added measurable benefits.

What This May Mean for Consumers

The implications of this study are significant for people and physicians who treat migraines. Beyond diagnosis, migraine is more than a medical condition—its constant presence dictates when and how people can work, study, and socialize. The Click Therapeutics data suggest a new avenue of relief that is readily accessible and shows the potential to reduce the burden of migraine in daily life.

In digital health, data is key.  Julien de Salaberry, CEO and founder of Galen Growth has often emphasized: “Data is the defining difference in how we can transform digital health into a category with the same rigor and trust as traditional biopharma.” This sentiment captures the critical role that data plays in not just validating the efficacy of digital therapeutics but also in driving their adoption and integration into mainstream healthcare​.”

Moreover, the trial was designed to be used alongside existing medications, which could assist people who feel they have already exhausted their treatment options. This is important for those who experience ongoing migraine symptoms despite the use of preventive, newer migraine medications. Digital therapeutics with demonstrated data may provide an added layer of treatment that doesn’t require the introduction of more drugs or drug-related side effects.

Future of Migraine Treatment and Digital Health

This trial’s success is more than a win for Click Therapeutics—it signals what’s possible in digital health. In demonstrating that a digital intervention can demonstrate clinical outcomes in a condition as debilitating as migraine, CT-132 may have set the bar for digital therapeutics and offers private and public payers reason to become excited about the category.

As more digital therapeutics enter the clinical landscape, their ability to integrate with and enhance traditional treatments will be crucial to their success. This trial shows that digital solutions can do more than provide “feel-good” supplementary support—they can drive measurable improvement in patient health. The data are essential to showing that hype cannot be a clinical option; digital health must deliver high evidence before being considered a serious patient option.

By setting this new precedent for clinical validation, Click Therapeutics has contributed to a more significant shift in how we think about digital health. It’s not just about innovation for its own sake—it’s about how technology can change how we manage health when designed with scientific rigor and people’s needs in mind.

The post Forget Hype – Digital Therapeutic Data Show the Category Can be Held to High Clinical Standards appeared first on Medika Life.

But what of the company that prioritizes using this powerful technology to become more efficient and faster – using powerful tools like ChatGPT and GenAI to primarily bolster the bottom line without adding value? Without policy bumper guards, AI might become a 21st-century dehumanizing sharp pencil in dispassionate bureaucrats’ hands.

“Digital technologies are changing the healthcare sector at an unprecedented pace,” notes Stan Kachnowski, PhD, HITLAB chair and host of the program’s ongoing Innovators Summit 2023 that brings together digital health leaders. “It is a priority area for the health ecosystem at large.”

At the 2023 Fall HITLAB New York City Conference, Downstate Health Science University CEO Dr. David Berger, offered counsel where medical institutions can shift functions that can be replaced by AI-driven tools. Berger shared a simple, thoughtful chart developed by Vineeta Agarwala, MD, PhD, a general partner at venture capital firm Andreessen Horowitz (known as a16z).

The Timeless Tussle Between Bureaucracy and Humanity

Vice President Kamala Harris spoke recently in London about the sharp double-edged sword of AI in health delivery and why the government will need to create business guidelines:

“AI has the potential to do profound good to develop powerful new medicines to treat and even cure the diseases that have for generations plagued humanity, to dramatically improve agricultural production to help address global food insecurity and to save countless lives in the fight against the climate crisis. But just as AI has the potential to do profound good, it also has the potential to cause profound harm.”   

Why is the Veep worried?  Are her comments overreacting or reacting to people’s irrational fears? Is the administration in Washington sending a message to big businesses that the executive branch sees potential risk to people’s health via AI? This hand-wringing is more than just bluster.  Just look at AI’s entry into the access to care payer process: perhaps an algorithm gone amuck?

UnitedHealthcare and Cigna Healthcare are already facing consumer backlash after claims that these payer behemoths use automated data to deny beneficiaries needed medical care. These allegations have already ignited a broader conversation on how insurers perhaps overly rely on artificial intelligence algorithms when processing claims or prior authorization requests.  

Wounded reputations, customer outcries, and diminished care reinforce why companies must not install AI in the decision-making corporate motherboard at the expense of the human touch. Indeed, having already touched the hot stove, CIGNA stepped forward to acknowledge that human connection is key to maximizing the potential of AI to advance the healing process.

Humanity in the Loop

“Above all else, a human must be in the loop,” suggests Andy Fanning, vice president of intelligent automation, AI enablement, and business transformation at The Cigna Group, in a statement. “Our AI solutions must be used to augment, never replace, the human experience — allowing experts to spend more time in the areas where they can apply their expertise.”

Ever evolving, the health sector is poised to take a giant leap forward by inviting augmented intelligence and large language models like ChatGPT into the fold as technology partners in care decisions, clinical trial design, drug discovery, health information, patient diagnosis, manufacturing medical supply, and, yes, the dicey decision-making process of payer insurance claims. The operative word must remain ‘augment’ – with these new technologies never fully replacing the human element in service of technological potential.

All concerned observers hope smart technologies will advance diagnoses, treatment plans, and preventive care, improve medical records accuracy and refine cost management.  Machine learning algorithms – like newbies on the job scene – require mentors. Technology cannot work in a vacuum.  People must have their hands on its wheel in creating algorithms. 

As the adage goes, “Garbage in, garbage out.” AI applications are only as practical as the cognitive sophistication of their mentor. But who are the people doing the mentoring? Pencil pushers? Bean counters? Compassionate healers? AI and ChatGPT have a prominent place in healthcare, but their absolute power over the delicate balance of humanity in care and corporate objectives is still uncharted territory.  Do we succumb to our fears? Do we embrace inevitable advances, no matter the cost?  That remains a “people” call.

The US and EU are navigating the fine line between intelligent innovation and protecting patient interests as they grapple with regulating GenAI. The outcome of these discussions is pivotal in shaping the future of health, ensuring its safe and responsible integration into medical practice and safeguarding patient well-being and data privacy.

Change is a Perpetual Threat

Always looking around the corner at the future of innovation’s impact on humanity, John Nosta, a global health and technology go-to, writes in Psychology Today:

“The intersection of AI and human cognition is as much about philosophy and ethics as it is about technology. If history is any guide, every significant technological advancement brings with it societal trepidation. The printing press, electricity, and the internet all were met with a mix of awe and apprehension. The introduction of AI into our cognitive domain is no different.”

For centuries, change has threatened the status quo – how we live and earn our livelihoods.  Blacksmiths faced the horseless carriage with understandable fear. Today, toll booth clerks and fast-food workers see automated toll and ordering systems as a threat. Innovation will often create employment disruption. It will also help us to redeploy talent in new ways.

Almost 50 years ago, physicians fought the passage of legislation establishing Medicare and Medicaid with full-page New York Times ads. For most, it signaled the rise of “socialized medicine” and the end of their decision-making power. Today, it’s embraced by Americans – regardless of political affiliation – as a social benefit and a fundamental right.  AI is the health professionals’ new nemesis. It might question their clinical calls or offer added perspective. As baseball Hall of Famer Yogi Berra said, “The future ain’t what it used to be.”

We must not draw lines of entrenchment in the necessarily symbiotic relationship between empathy and augmented intelligence. The yearning for healing and the desire to heal has always called upon human touch, compassion, and knowledge. AI offers the greatest potential to serve as an extension of our intellectual, experiential, and emotional capabilities of any technological innovation we’ve seen to date.

ChatGPT and GenAI provide tremendous value, but they should be tools to enhance and complement human capabilities rather than replace them.

Empathy is at the Heart and Soul of Health

To understand the profound significance of human empathy in health, we must first acknowledge its irreplaceable role. Empathy is the cornerstone of effective patient care. It’s the ability to understand and recognize the feelings of the “other,” offering solace, compassion, and a comforting presence when people and their families face medical challenges.

When someone receives a life-altering diagnosis or undergoes a challenging medical procedure, the human touch provides reassurance and support. Empathetic clinicians, with their ability to connect on an emotional level, instill trust, alleviate fear, and foster a healing connection. No machine, no matter how intelligent, can replicate the power of human empathy.

AI and ChatGPT as Extensions of Human Capabilities

But AI and ChatGPT, in particular, may take a front seat in healthcare. They serve as invaluable extensions of our cognitive abilities. These technologies excel in tasks that require vast data analysis, pattern recognition, and information retrieval. By handling the data-intensive aspects of health synthesis, health professionals can focus on what they do best—providing amazing medical (and compassionate) care.

AI is not a competitor but a collaborator. It can sift through mountains of medical data, identify trends, and suggest potential treatment options, enabling healthcare providers to make more informed decisions. AI can rapidly process radiological images, analyze genetic data, consider the possibilities of undiagnosed rare diseases, and even predict disease outbreaks, all of which contribute to more accurate diagnoses and better patient outcomes.

One of the world’s most forward-looking thinkers on AI in medicine is Tom Lawry, former national director of AI at Microsoft, author of the business bestseller Hacking Healthcare, and now an advisor to health leaders suggests:

“Generative AI is the latest flavor of many flavors of what’s known as artificial intelligence. So, I like keeping things simple. So to your point, let’s assume AI is really related to IT systems, the sense, comprehend, act and learn. Probably, more importantly, it’s intelligence demonstrated by software with the ability to depict or mimic human brain functions. And I want to emphasize mimic human brain functions, not replace.”

Acknowledging this delicate dance is critical to harnessing the full potential of ChatGPT and GenAI in health. AI can enhance health efficiency and accuracy. Yet, it should always work in conjunction with human empathy. The two can harmoniously coexist, with AI as a valuable tool in the healthcare provider’s toolkit.

We must ensure that technology remains a faithful servant of empathy, not a quick and efficient replacement. AI can handle repetitive tasks and hone data-driven insight – it can scrape data from unwieldy electronic medical records.  But human touch provides emotional support, compassion, and a connection that cannot be replicated. ChatGPT can make the consumer seeker comfortable mining information around sensitive and potentially embarrassing questions. But getting medical help requires a relationship between healer and seeker.

Cognitively Sharp Physicians and the Future of Patient Care

Cognitively sharp individuals embracing AI and ChatGPT as extensions of their abilities can leverage technologies most effectively. More and more medical schools will need to shift their curricula to focus on the psychological power of empathy in healing and patient adherence. More and more physicians – with their iconic white coats and rank-signaling stethoscopes – will need to hone people skills to secure their positions as medical superstars.

AI will assist in diagnosing complex diseases, suggesting personalized treatment plans, and even providing real-time information during surgical procedures. When healthcare professionals integrate AI into their workflow, they become empowered with a wealth of data-driven insights, enabling them to make more precise decisions and deliver better patient care.

The Needed Partnership

The connection between human empathy and AI is not a zero-sum game. The essence of humanity in health delivery will continue to lead the way, with AI acting as a supportive ally. The health industry will thrive in this ever-evolving landscape by calling for a harmonious balance between providers’ emotional intelligence and AI’s fact-finding possibilities. United, human and machine will drive innovation, improve patient outcomes, and ensure humanity remains at the heart of health. In the delicate dance between human empathy and AI, the patient must always be the center of our focus and the defining voice that guides response.

The post The Defining Dance Between Empathy and GenAI in Health appeared first on Medika Life.

But the impact of smoking is all around us, even if we don’t see it. Statistics rarely tell a provocative story to compel people to action. The numbers behind the global smoking epidemic are so stark, however, they are almost incomprehensible. Behind every data point, a real person, family or community is impacted.

Let’s start with the challenge: More than 1.3 billion people – 17 percent of the global population – smoke cigarettes or consumes other tobacco products. Since the first World No Tobacco Day in 1987, nearly 300 million people have died from smoking-related illnesses, including tens of millions who died or suffered respiratory or cognitive impairment from second-hand smoke. If the average day is any gauge, thousands of children took up smoking yesterday, including the fastest rising of all groups: teenage girls. Beyond the impact of lives lost or harmed, smoking costs the global economy roughly $2 trillion in economic damage every year.

With that money, with those lives lost, what could be done to improve the world? A lot, as it turns out. That sum would fund the attainment of many of humanity’s most ambitious sustainability and poverty alleviation goals. We could facilitate an equitable transfer to cleaner energy technologies for industrialized and emerging markets. And to be blunt, we would have an honest shot at dramatically reducing cancer rates and chronic disease when a massive chunk of the world’s people isn’t inhaling products that contain more than 7,000 different chemicals with each puff.

Perhaps eliminating smoking is a pipe dream. Governments have imposed stiff taxes against tobacco products; research is being used to counter cigarette advertising; social stigma has built in many countries and health systems have made smoking habits increasingly punitive. But that hasn’t slowed the epidemic. We need better tools.

Around 60 percent of smokers globally – 780 million people – say they want to quit, but only 30 percent have access to resources to help them achieve that goal. That represents a massive market opportunity for the right solutions. Education and support networks are essential. However, smokers need access to more powerful cessation products to deliver a knockout punch. Fortunately, there is some good news on that front.

While smoking cessation products have been available for nearly two decades, they can have serious side effects and rebound rates. Last week, results for a confirmatory Phase 3 clinical trial – ORCA-3 – showed statistically significant results over six and 12 weeks. The study features a new cessation treatment called cytisinicline, a plant-derived alkaloid.

Most of the trial’s participants have been smoking for more than 30 years and have tried to quit on average four times. In the study, cytisinicline demonstrated a six-fold increase in the odds of maintaining continuous smoking cessation at six months compared to the placebo.

The new cessation treatment also produces far fewer side effects than routinely reported by people using other smoking cessation products. This is particularly important since compliance with treatment is a significant barrier that keeps millions of people from following through with their goal of quitting.

Cytisinicline opens a new front in the war to end smoking. The task is to ensure it and other tools reach the people who need it most. Advocacy groups and government agencies can help with this important next step by breaking down the barriers to access that frequently inhibit people from acting on the dream of kicking their smoking habit. It’s time to lend them a hand.

The post It’s Time for New Tools to Overcome Smoking appeared first on Medika Life.

This article contains claims that many will consider incendiary and anti-science. It therefore requires context and if you indulge me for a minute or two, I’d like, at length, to provide background before we address the large mammal. Words have power and we use them to record our history, describe the world around us, create narratives and chart the future. We use words to communicate our deepest thoughts, describe our fears and share our joys. And then, in some instances we use words to lie, both to others and ourselves.

I understand fully the responsibility that comes with the gift of being able to convey complex ideas to others, more importantly however, I also grasp the moral obligation attached to the gift. It should only ever be used for truth, or in the pursuit thereof. Science isn’t that different. It relies on words to describe complex concepts, often utilizing its own specific language, one that for most laypeople, places much of what is discussed beyond reach.

I am, for the record, a disciple of science. I believe. I always have. The logical purity of numbers and the wonders of the natural world are intertwined in an almost mystical fashion and our salvation, as a species will undoubtedly depend on science. Much like the Spiderman character however, the ability to wield an understanding and control over the natural world grants the scientist almost unlimited power. Power that, you guessed it, requires responsibility. Responsibility, morals and a strong sense of ethics.

That it what this article is about. It is not about science per se, but rather about the consequences we now face from the abuse and corruption of the discipline, morphing it into a tool whose primary focus is profit and control, rather than the betterment of our species. That, unfortunately, makes the brand of science currently being practiced, a danger to you and I. A fact the pandemic has highlighted with stunning clarity.

mRNA is the Pandora’s box of science, one of many advancing technology has uncovered. Make no mistake, mRNA holds huge promise for medicine, potentially even rivalling the discovery of penicillin. You can read an article I wrote on that exact topic in 2021, exploring the promise the technology holds.

So no, I am clearly not anti-science, at least not when the science being practiced is honest, ethical and cautious science, science that is aware of the potential impact of its actions on society and our wellbeing. That is not the science we have endured for the last three years, and we need to speak up. We have been systematically and intentionally lied to, misled and chemically abused for the last two years of the pandemic, potentially even right from the outset. Misled with words, scientific phrases couched in ambiguity and force-fed fear by the mass media, at the behest of politicians and scientists.

Now, when the dust settles, we need to face uncomfortable truths and a world that has changed, in ways we have yet to fully grasp. So, to the article, and if you should find yourself at odds with it, please, at least consider the questions it raises.

The Viral Elephant

If, and the “if” is looking more and more likely, the entire human race was just exposed to the first genetically engineered virus, we need to be urgently addressing the elephant in the room. The effects of the SARS-COV2 virus on our physiology are widespread and complex and it is critical more time is spent reverse engineering exactly how the virus was altered to increase its transmissibility.

I came across an incredibly interesting article while writing this piece from one of Medika’s contributors, William Haseltine, that describes in detail one of the unique tools this novel virus utilizes to evade and suppress our immune system. The article may prove heavy going for some, but it is an excellent read and provides insight on just how well adapted the virus is at exploiting our defenses.

Far more than being a one trick pony, SARS-COV2 is the Swiss army knife of viruses and we, unfortunately, are the can of baked beans.

You may notice how I refer to the above tool as unique. Its a term used all the time when discussing this virus. It is unique and the more we discover about it, the more likely it becomes that it was intentionally weaponized (for whatever purpose) to exploit our physiology. Simply put, the virus that has killed millions across the globe was likely released from the Wuhan Institute of Virology. It is a product of science, American science, it is worth adding, practiced at a safe distance, on foreign soil and funded by American taxpayers.

For the first time in the history of humanity, over the course of the next two generations, this genetically manipulated virus will have infected the entire global population. For those who escaped the virus itself, there is no escaping the engineered bits (or spike protein) that have been artificially stimulated in your system by the mRNA vaccines. So the extent of the damage caused by the SARS-COV2 virus and its ability to access our entire physiology is not surprising, given it was designed for exactly that purpose.

We now face a new kind of threat, unknown medical risk by intentional design, a threat for which we are physiologically unprepared. This new world is filled with unknowns. Future mutations, revisited on us by livestock as we infect a host of animals that live in close proximity to us, or a reversion to the original SARS strain, far more deadly than SARS-COV2. How the virus and the vaccines impact our immune system’s response to future viral attacks is also up in the air. These are the issue’s we should be addressing now, with a sense of immediacy.

It is not melodramatic to suggest our species survival may depend on it, and if you think this is being melodramatic, then you still haven’t grasped the gravity of what has just unfolded.

The first step in this process requires accountability from the players involved, most notably EcoHealth Alliance, Peter Daszak, Anthony Fauci, Kristian G. Andersen, Dr. Ralph S. Baric, Dr. Shi Zhengli, et al. must be made to cooperate with a view to establishing the exact nature of their Gain of Function research on coronaviruses. Exactly what did they cook up in the lab in Wuhan and what else resides there on ice, patiently waiting for the next breach in safety protocols.?

It is also worth pausing a moment to consider the irony of the last three years, of looking to those who created the SARS-COV2 virus for our salvation.

The pandemic is rapidly transitioning from a global viral infection to chronic, long-term complications, with a range of symptoms so broad, doctors are at a loss as to how to define and treat them. Covid vaccines may play a significant, but as yet, unquantified role in many of these chronic and often fatal conditions, further muddying the waters. To truly understand which actor, the vaccine or the virus, both manufactured, may be to blame for the afflictions faced by millions, we need reliable, unbiased research and securing that is proving increasingly difficult.

Sifting Quicksand

Every corner of science and the politics that governs it has skin in the Covid game. The pharma industry, perhaps best positioned to carry out large-scale clinical research, can no longer be trusted. Any data released by pharma relating to anything pandemic related – especially in the absence of critical, independent third party review, cannot and must not be taken at face value.

The original Covid mRNA vaccine trials are evidence of this. The trials (170 people, in case you were not aware) were subjected to the most appalling “management” of candidates and data to validate the vaccine’s safety. Rapid development of a vaccine or treatment was of the essence to alleviate a collapsing medical infrastructure that was buckling under the pressure of the pandemic. Moderna took 28 days to solve the problem. 28 days. I’d say it again, but you can draw your own conclusions.

After nearly two decades, we hadn’t managed to develop a vaccine for the original SARS virus and yet, 28 days later, we had a working SARS-COV2 vaccine ready for clinical trials. The absurdity of this and the euphoric acceptance of this break with scientific reality go a long way to illustrating the desperation felt by many in the early days of the pandemic. Logic would rather suggest the virus was familiar to both Moderna and Pfizer prior to 2019.

Government agencies within the U.S. have been deeply complicit, providing funding via the NIH and the NIAID for developing and effectively weaponizing coronaviruses, ostensibly for the purposes of “further research.” Their ability to provide unbiased opinion on what poses a danger to the public they serve has been compromised. It is essential, moving forward, that both the FDA and CDC are overhauled, effectively preventing their pursuit of policies that place the public directly in harms way. Take their latest unanimous advice on vaccinating children as young as six months with mRNA vaccines.

Possibly the greatest indictment of the CDC is their mismanagement of VAERS. The CDC took 15 months before it finally evaluated data from the VAERS system in June of 2022. VAERS is a dedicated tool for collecting reports on vaccine side effects. So why wait 15 months? No sense in checking data for safety signals to simply verify what you already know, is there? Once you’ve checked that data, you can also no longer ignore it.

Every academic medical institution capable of performing the required research we so desperately need is at the same time beholden to outside funding. Research grants and future employment are dependent on not rocking the boat. To produce data that conflicts with, compromises or exposes funding sources (for the most part, pharma) is the equivalent of professional suicide and banishment to the land of the unfunded.

That leaves us with the politicians, whose agendas are rarely fueled by the best interests of the public. Although elected by us, they are all cling to the purse strings that enable them to reach their lofty heights. We will probably never know who orchestrated the official pandemic narrative, but it was the politicians who enforced it. In 2023, despite irrefutable evidence that disputes this narrative, most still repeat it ad nauseam.

To understand just how interwoven this has all become, take Peter Daszak, appointed by the WHO to head up a team to investigate the possibility of a lab leak in Wuhan, effectively policing his own research. In record time he appeared on camera, stating that his investigation had turned up no evidence of a breach in the Wuhan Institute of Virology. Lie upon lie, layer upon layer of deceit and deception. Little wonder then that trust is science is at an all time low.

Given the above, where do we then turn for reliable, agenda free research that is motivated only by the pursuit of the truth? We need to overcome this seemingly insurmountable obstacle before we can even consider unpacking the plethora of virus related questions that require answers. Some would suggest, the World Health Organization is best placed to oversee an investigation, but they too, possibly more than any other health body, are riddled with conflicts of interest on every level.

One thing is glaringly apparent though. There is large and growing body of evidence supporting the fact Covid vaccines are harming some, in many instances, fatally, which begs the following question.

WHY DO WE CONTINUE TO USE THEM? Why have we extended vaccination to healthy children and why does the CDC support this and promote it? How, in good conscience and with the safety of the public in mind, can governments and regulatory bodies allow the current narrative to continue? The study I have linked to above, references post vaccine induced myocarditis. Myocarditis post the Pfizer-Moderna combo was 28 times more common than post-Covid in 16-24 year old males in this massive Nordic study.

Impunity and the Point of No Return

No one is coming to save us and any hands that reach out from the medical and scientific community must, in light of the last three years, be considered tainted by default, until proven otherwise. This is the sad reality of where we currently find ourselves. Everyone in a position to put an end to the current pandemic narrative is compromised. They have passed the point of no return and although many may be racked by feelings or remorse, there is no world in which anyone admits fault, in particular to the virus’s origin and the efficacy of the vaccines.

That wonderful phrase “Let he who is without sin cast the first stone” is absolutely applicable. Everyone sold the narrative and no one institutes an investigation in which they are also likely to be held accountable. Add to this, a growing number of individuals, intimately involved in the pandemic, who act with absolute impunity and concern only for shareholder and personal profit – or glory – and we seem to find ourselves in a spot of bother.

Realistically, no one in a position of power or acting from within the industry is going to the sound the alarm. Our only hope of getting to the truth lies in picking at the edges of the tapestry until it frays and pulls apart. It is left to fringe reporters to harass individuals like Pfizer’s CEO, Albert Bourla, who was accosted recently in Davos by two reporters from Rebel News. He was peppered with questions about their vaccine, its efficacy and more. Understandably, he diplomatically kept silent .

An eminent British cardiologist, Dr. Aseem Malhotra has also taken a stance against the vaccines and their manufacturers after the death of his father from a vaccine related illness. He is among a rising number of influential voices now starting to speak out publicly to call for an end to the mRNA vaccination campaign.

It is by no means a simple task or one for the feint of heart. Censorship is still frequently applied to any information that questions the ongoing Covid narrative, and on many social media platforms, content and users are still frequently de-platformed and often professionally sanctioned. Many have turned to Twitter, which, in recent months, since it’s acquisition by Elon Musk, has stopped censoring information that conflicts with the official narrative on the pandemic.

I’ve shared many articles during the last three years, relying mostly on common sense to question the incredibly dubious public health decisions as they’ve unfolded on a very public platform. At this point in the pandemic, we are now confronted with a very new and real threat, in the face of which, who did what, where, when and why, become almost irrelevant.

Mankind 2.0

What legacy will SARS-COV2 leave in its wake and how does that impact us and future generations? What long term impacts will the continued boosting of a novel drug with an abysmal safety record have on our physiology? What has it done to us over the last three years?

The truth is, we really don’t know the answers, which, in some instances, will require time and separating the vaccine’s effects from those of the virus have now become a research nightmare, thanks to the billions already vaccinated. In 2021, a group of academics valiantly tried to sound warning bells, this incredibly detailed article highlighting the potential dangers of mRNA vaccines.

We are headed into troubled waters, from a public health perspective. We may yet be plagued for generations to come by the ill effects of both the virus and the vaccines, no matter their delivery methods. More so, there is swirl and mistrust in voices of influence.

Long Covid, vaccine Serious Adverse Events (SAE’s – to many to list here) and strokes and heart related damage, in many instances fatal, already blight the medical landscape. Worryingly, the younger members of society appear to be as prone, if not more so, to developing adverse reactions, perhaps because their immune responses to the vaccine are more pronounced.

Humanity may have undone humanity, only time will tell. Time is needed to sort-out fact from fiction – probability from certainty. The responsibility now rests with us (you and I) to ensure we attempt to repair the damage and prevent any further rushed science being put to trial in the public space.

What can you do, you ask? Research all sides of the conversation. Ask questions and demand answers from those you have placed into positions of accountability. The truth will out – over time. Make your own, informed decisions – balancing your personal care and risk/risk – the risk of the current virus variant alongside your health status.

I’d ask one more thing of you. Trust your instincts and try to approach public facing pandemic information with a critical mind. There is almost always an agenda, from both sides of the fence and a little digging will normally uncover it. It’s time to leave the safety of the flock. In case you hadn’t noticed they’ve appointed the wolf as shepherd.

As a parting thought, please don’t vilify science. It is as much a victim of the avarice and greed of humanity, as we are. Perhaps, while we attempt to save ourselves, we can, in the same moment, rescue science. We are going to need it.

Missed Part 5 of the Covid Files on The Origins of Covid? Catch up here.

[EDITORS NOTE: The author is pro public health, pro science and pro vaccination. In this situation, he raises important questions and concerns for readers around the Covid SARS2 virus and Covid treatment approaches. His goal is to get people thinking in the best interest of future health innovation.]

The post Covid’s Elephant in the Room. We Must Address it appeared first on Medika Life.

Significant change is needed. But what change? Lowering drug costs will not lower total spending on health so long as pharmacy benefit managers (PBMs) continue to profit from the “spread.” Access to care will not improve so long as we ponder the future of essential telehealth services. Patient adherence will not be supported if formularies can call upon “non-medical switching” as a go-to negotiating tool. The US percentage of GDP will not align with other developed nations’ investments in health if we don’t redirect effort to emotional and physical preventive and value-based care. Fixing one piece of the healthcare puzzle is helpful – but is it transformational?

There are changes afoot that we need to make happen sooner rather than later by moving minds, systems and behaviors so that life-sustaining and life-saving approaches to patient care may eventually tip the scale of human survival toward health and wellness. However, we see data through the lens of a human perspective – sometimes self-interests or emotional needs for control.

Here are 10 possibilities that are not dreams – they can happen – if the health ecosystem leaders think beyond cost, reimbursement or authoritative voice and focus on people’s healthy longevity:

1. Artificial Intelligence (AI) — A future of engagement and collaboration:

AI has been around since the Gutenberg Bible! In 1899, medicine made a giant leap into AI by publishing the Merck Manual — a handbook that collected all known medical advice and gave physicians a compendium of diagnoses and treatments. No expert can remember the vast canon of medical information within their specialty, and books became a source of “augmented knowledge.”

Too many health systems and physicians view AI as “novel.” Addressing the obstacles to implementation within their health systems is critical to enhanced decision-making benefits offered by AI. Concerns about cybersecurity and training are valid! However, the value of implementing artificial intelligence is not about embracing technology — it’s about amplifying human wisdom to address patient urgencies effectively.

Human intelligence can be augmented by uniting data, patient files and other health professionals’ patient-care experiences, channeled through this technology platform. We must now rally to address questions about data quality, emotional resistance to change and cybersecurity. As innovation theorist, John Nosta writes about the emerging importance of aligning IQ and EQ with TQ (technology quotient).

“The battle of man versus machine might be ending where cooperative engagement provides transformative solutions to a wide variety of problems and opportunities.”

2. Behavioral Health — America does not lack a supply chain to manufacture chronically ill citizens:

We are killing ourselves slowly…with poor nutrition. We continue to add belt notches to our waistlines. The added weight also increases risks for heart disease, diabetes, cancer, mental health stressors, and more. Who pays those sickness bills? Employers foot a large percentage of the nation’s workforce health insurance. It’s time to look beyond providing an expected workplace benefit. Physicians, employers, payers and the people they seek to help must reduce the waistlines of people tipping toward the obesity border! Helping consumers shed unnecessary pounds and meeting their corresponding medical priorities offers immediate life-saving and personalized health benefits.

The best option for corporations footing a large part of the health bill is to intervene with payers and recognize benign neglect in tackling the obesity epidemic only adds to suffering and expense. Louis J. Aronne, M.D., who founded the breakthrough patient-centered health-tech Intellihealth along with Weill Cornell Medicine physician colleague Katherine Saunders, MD, notes:

“Obesity is a very complex chronic disease with a number of causes from diet to underlying medical conditions, medications and genetics. “Through our extensive research and applied medical model, we have incorporated all of our practice methodologies into a single software platform, which delivers a blueprint for treating obesity with supervision and continued oversight. Evaluation of our approach demonstrates 3x the number of patients reaching the key outcome measure of 5% or greater weight loss compared to programs that incorporate behavioral interventions alone.”

3. Decentralized Clinical Trials — Democratize drug development:

Even before COVID-19 appeared, traditional clinical trial recruitment models were being reconsidered. Drug development was almost sidelined during the pandemic, and clinical research organizations (CROs) recognized that they needed to reinvent patient recruitment. Operation Warp Speed showed how to put the pedal to the metal for COVID-19 vaccines; systems developed now can be applied to other high-priority, clinical urgencies such as treatments for rare diseases and often-fatal cancers.

Collaboration to advance the process is working. Science and research pioneers such as Amir Kalali, MD, and Craig Lipset, who co-lead the industry-wide DTRA.org group, show the sector’s readiness to change direction collectively. Innovators like Michelle Longmire, MD, CEO of Medable, and Irfan Khan, MD, CEO of Circuit Clinical, demonstrate that an industry known to advance new medications from bench to bedside can innovate how and where patients are invited to participate in urgently needed therapeutic discoveries. Innovation is based on finding new paths to address unmet needs.

To accelerate drug discovery and development possibilities, biopharma and medical device companies need to find a new set of allies – patient advocacy organizations and their communities; primary care centers with access to people in rural and inner-city communities. They must recognize that in working with government, sector companies, and those that seek to serve – people with health needs – they can go farther, faster.

4. Digital Health — Physicians and patients need coverage clarity:

Food and Drug Administration approval for life-sustaining innovations does not necessarily sway payer access decisions. “Claim denied” is the all-to-often refrain when physicians and their patients seek access to a 510 K-approved medical device or digital therapeutic.

Payers may have sufficient justification to deny coverage. But what are the criteria for those “dead-on-arrival” reimbursement decisions? What are the guidelines to secure formulary approval? If more data are needed to ensure access for patients — insurance customers — payers must become partners in the sector’s and patient-care success. Adding bricks to the walls patients must circumvent to secure care for themselves and their families does little to improve care or customer relationships.

Digital health analyst and author Artur Olesch outlines a challenge for the coming year in a question many more should be asking:

The COVID-19 pandemic has accelerated the implementation of telecare and telemedicine. Individuals are increasingly using mobile health apps. What can be done not to waste this potential?

5. Ecohealth — We need a healthy planet or else:

Where you live impacts how long and how well you live. Thousands of U.S. communities are ticking time bombs. The harsh reality is that 26% of Black Americans and 29% of Hispanic Americans live within three miles of a toxic landfill site, exposing these communities of color to dangerous levels of lead and other heavy metals and chemicals. We must face the harsh reality that while planet earth can do just fine without humanity; humanity needs a healthy planet. This was the striking call-to-action by Meharry Medical College President and CEO Dr. James E.K. Hildreth.

The longer we wait, the harder it will be to course-correct. The shift to a healthier world requires other innovative superpowers — courage and collaboration. According to Bob Martineau, senior partner FINN Partners, a former Federal and State government official focusing on environment issues: 

Though we breathe, eat and live in the environment, we often forget just how interconnected all aspects of our health are with the world around us. Exposure to dangerous levels of air, soil and groundwater pollution is proven to cause a cascade of life-threatening woes that include cancers, nervous system disorders, respiratory diseases, and premature births.

6. Tackle older patients’ care and adherence challenges:

When people are diagnosed with a chronic or severe medical condition, we must ensure that the patient-physician relationship guides care and that the medical ecosystem prioritizes medication adherence. The National Health Institute reports that 40% of patients sustain significant risks by misunderstanding, forgetting, or ignoring healthcare advice. We don’t need to invent or create new care challenges. Let physicians already seeking to do good oversee clinical-care decisions.

Age discrimination and comfort with using technology to access the health system are barriers to access and understanding medication use and adherence. Age bias is often attached to health conditions often experienced in older persons. While older Americans often are the health system’s most significant customers, they face continued discrimination. We must see continued innovation in earlier detection of illnesses that impact seniors, such as loneliness, Alzheimer’s and even sexually transmitted diseases.

7. Health disparities — The most vulnerable need access to care now:

Decades of racism place people of color in harm’s way from COVID-19 more than any other community. Blacks are dying at a rate of 50.3 per 100,000 people, compared with 20.7 for whites. In New York City, the most densely populated place in America, 19% of residents, many people of color, live in poverty, while 17% live in overcrowded conditions. We seem unable to come to grips with the reality that health disparities cause multiple public health disasters and cost lives and dollars.

We must reach the communities that seek information in ways that speak to their interests and needs. What groups such as Hip Hop Public Health creatively use the power of music with health-specific messages to mobilize and change mindsets.

America is among the few developed nations that deny good healthcare services to those most in need. Neglect and racism are morally counter to the health mission of medical leaders. The changes of senior citizens to access health networks easily must be addressed. Policymakers, corporate leaders and citizens must raise their voices to enact change. A cultural shift is needed to rally communities for awareness and education. According to Yele Aluko, MD, MBA, chief medical officer at EY:

The current conversation going on nationally about societal justice, about health equity, drives a moral imperative. This conversation is going on across health systems, big business, government, and philanthropic organizations. Everybody’s talking about how we need to fix this wrong, so the time is now. We have a convergence of goodwill that drives my optimism. But we must seize the moment and translate it into actionable solutions.

8. Metaverse — Smart technologies channel our imagination toward curative possibilities:

Do you have an imagination? Put it to work to heal. After all, medical engineering is a pioneering effort that connects people’s ideas with human biology to overcome sickness. We entered the “Matrix” the first time we imaged a therapeutic stent, LVAD and 3D-printed artificial limb; complex operations became possible when expert hands drew upon technology to realize new concepts.

Rafael Grossman, MD, FACS, has been tapping technology to improve patient-centered medical care. Always ready to explore the disruptive power of technology in medicine, Dr. Grossman has been at the forefront of using smart glasses, augmented, virtual and mixed reality to change the way we practice and teach medicine.

Grossman and medical compatriots such as Daniel Kraft, MD, don’t see the metaverse as sci-fi. Artificial reality, virtual reality and wearables are used by leading-edge practitioners to advance patient outcomes.

9. Remote Patient Monitoring and Telehealth — Remote care after COVID-19:

Digital systems are built into beds, furniture and watches. Medical wearables make hospital stays more customer-friendly by delivering patient information straight to providers’ smartphones and central monitoring stations. At the height of the pandemic, there was a dramatic uptick in telehealth and remote care. As reimbursement rates shift, patients worry they will lose the benefits of remote care.

Ever so often, Congress, the Centers for Medicare and Medicaid Services and private payers pump the brakes on continued remote access with life-saving services such as telemedicine. We need to change the culture of conservatism when it comes to remote advancements and access. Groups like the American Telemedicine Association are essential voices for access and a sensible hybrid approach to care.

Medicine is a culture where patients are not yet seen as customers. Cancer survivor, caregiver and health professional Stacy Hurt, a HIMSS Digital Health Influencer and recent participant in a VyTrac-sponsored webinar on remote patient monitoring, writes on the importance of a hybrid approach:

Patients ultimately want two things: hope and options. We’re finally to a point where telemedicine is an option. It for sure shouldn’t replace the in-person encounter and relationship between the healthcare provider and patient, but it is an option we need to preserve.

10. Self-Care — Our health system keeps us alive — it doesn’t keep us well:

Our health system is not built around sustaining “health.” We have invested mightily in national illness management, a sick-care structure that offers no return on investment regarding a better path to healthy longevity. Value-based and preventive care to keep the illness at bay is a big win-win-win for households, companies and governments that now foot the nation’s health insurance bill. Employers and payers will find that incentivizing self-care and illness prevention is a more innovative business model.

WebMD Chief Medical Officer John Whyte, MD, an author on bestsellers with life-saving tips to reduce cancer and diabetes risks, writes:

The biggest myth has been that (cancer) is primarily caused by genetics or just bad luck and there is nothing that you can do about it. The reality is only about 30% of cancer is caused by what we would say are inherited mutations or family history. The rest is primarily influenced by lifestyle. I know, although nothing is 100% preventable, we have learned through science that you can reduce your risk by deciding what you eat, how much you exercise, your level of stress, the quality of your sleep. These are all things you have control over.

If this roster of innovations in hand tells us anything, it’s time we put health-system mindset change front and center. There are plenty of great reasons to say, “this won’t work” or “let’s not do it; it adds to costs.” It is understandable that new products, services and approaches take time to implement and cost money. But when we look at people’s well-being, adding complexity to people’s lives that separates them from access to the best quality of care has never been medicine’s intended mission.

We look to changes such as Amazon purchasing One Medical as a pathway to fix that which is broken. We have an abundance of innovative, readily and inexpensive (often generic) medicines. We often can speak with a skilled health professional through our smartphones and tablets. Perhaps the change so sorely needed isn’t another billion-dollar acquisition and “roll-up,” it’s addressing the challenges of collaboration and transparency?

Health providers are at the forefront of confronting our significant societal challenges. They have risen to the task heroically. Health disparities between the haves and have-nots and developed and developing nations have opened our eyes and hearts. Innovation combined with our determination must open the door to fundamental system change.

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BELFAST, Northern Ireland and NEW JERSEY—September 20, 2022—Cumulus Neuroscience (Cumulus; the Company), a global digital health company developing multi-domain digital biomarkers for the brain, today appointed Aman Bhatti, MD, as Chief Executive Officer (CEO). Dr. Bhatti, a noted digital health executive with experience launching and scaling world-renowned consumer healthcare brands, joins Cumulus as the Company shifts toward healthcare and expands biopharma partnerships in its next growth phase. Dr. Bhatti’s appointment follows the recent award of a £1.5M UK National Institute for Health and Care Research (NIHR) grant to Cumulus and its academic research partners, using the Cumulus platform to improve early dementia diagnosis.

“Neurological disorders are a global health issue, and digital biomarkers – which require integrated, multi-domain assessment technologies – are key to supporting faster drug development, disease diagnosis, and therapeutic solutions,” said Ruth McKernan, PhD, co-founder & executive chair, Cumulus. “Dr. Bhatti’s proven track record of implementing strategies that achieve significant revenue growth in both the biopharma and healthcare industries, combined with his unique understanding of healthcare system priorities and patient, physician, biopharma and payer needs, makes him the ideal match to lead Cumulus in its next chapter. With Dr. Bhatti at the helm, Cumulus is poised to accelerate our BioPharma and Healthcare commercialization strategies – to help solve the biggest healthcare challenges in neurodegeneration and psychiatry.”

“My passion is finding the intersection of technological innovation, scientific understanding, and patient care, to make better health possible – and Cumulus technology is poised to do just that, by enabling better understanding and faster identification of neurodegenerative and neuropsychiatric diseases,” said Bhatti. “Our technology already plays a key role in helping biopharma partners accelerate drug development, and soon, the same technology will be deployed to physicians to lead to earlier diagnosis and treatment of Alzheimer’s and other CNS diseases. I look forward to expanding those opportunities for our biopharma partners and patients, and to building toward the launch of our Cumulus platform to clinicians in the US. I’m also particularly energized to continue leading the industry in its evolution from paper-based, single-timepoint and single-domain assessments to using repeatable, multi-domain, AI-based clinical insights that are changing the face of drug development and patient management,” he added.

Brian Murphy, PhD, co-founder and chief scientific officer, commented: “Current solutions to measuring brain function don’t satisfy patients, doctors or the scientists who are working to develop new life-changing therapies. Our machine-learning enabled platform directly measures how a disease affects thinking capability, sleep, mood, language and other aspects of a patient’s daily life. With Aman on-board, the team is excited to bring this easy-to-use solution to bear in global health-care systems.”

Before joining Cumulus, Dr. Bhatti was senior vice president of AliveCor BioPharma, where he led a team focused on establishing partnerships with CROs and biopharma companies, drawing upon more than 15 years of experience in prior executive roles at Sanofi, GSK, Novartis and Reckitt. A pioneer in forging technology-based alliances, he was part of efforts to launch and scale well known global consumer brands such as Mucinex, Theraflu, Flonase, Nicorette, and most recently, KardiaMobile.

Focused on transforming diagnosis and patient care for Alzheimer’s dementia and other central nervous system (CNS) disorders, Cumulus is backed by a strategic investment led by the Dementia Discovery Fund (DDF), a specialist venture capital fund which includes leading pharmaceutical companies Pfizer, Lilly, Biogen, J&J, GSK, and Takeda. Its science is validated by recent data demonstrating that an easy-to-use, task-driven electroencephalogram (EEG) can yield clinical-grade data in large-scale, real-world investigations in neuroscience with extremely high adherence rates (Front. Digit. Health, 29 July 2022) – providing drug development partners with advanced diagnostic tools that generate insights into neurological activity, and better serve patients.

To learn more, visit www.cumulusnero.com.

About Cumulus Neuroscience

With a mission to generate the data and insights required to accelerate diagnosis and management of central nervous system (CNS) disorders for millions of patients and caregivers around the world, Cumulus Neuroscience is advancing an AI-based, multi-domain digital biomarker platform to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care, beginning with dementia and Alzheimer’s disease.

Designed to provide an industry-wide standard for real-world measurement of disease progression, Cumulus combines patented technology, in-house expertise and key industry partnerships to capture large amounts of real-world, clinical data repeated over time, across multiple behavioral and physiological domains in the patient’s home – all by a certified medical device package. Together with machine learning (ML) analytics and an extensive real-world database of annotated, longitudinal, matched data, Cumulus simplifies and improves the robustness of neuroscience clinical trials to provide the best and most cost-effective assessment of CNS treatment outcomes.

The Company is supported by highly experienced specialized investors, DDF/SV Health Investors, LifeArc and Future Fund, and a world-class Scientific and Technical Advisory Board.

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Just transplanting an animal’s organ into a human will not work. The person’s immune mechanisms will immediately reject the transplanted organ. So, what is to be done? The key is to genetically engineer the animal to produce organs that are less likely to be rejected. In the last 20 years, there’s been substantial progress on the research front to produce genetically modified pigs. Why pigs? Pig organs are about the same size as human organs but also share many physiologic similarities.

Recent technologies, including CRISPR, have allowed more possibilities to genetically engineer the pig’s genome. A few specific genes have been identified that are critical. Some were modified and some inactivated, called “knocked out.” It’s not just a matter of changing the pig’s genetics, but it’s also having a very specific anti-rejection drug combination. This includes the standard drugs used to prevent rejection of human organs and a specially designed monoclonal antibody against a part of the immune system called CD 40. This monoclonal antibody has been found to be essential and critical to the successful transplantation of a heart in the nonhuman primate model with animals maintained without rejection for upwards of 900 days.

In September 2021, a xenograft kidney from a genetically engineered pig was placed in a brain-dead patient still on life support. It was observed for 58 hours at the New York University Langone Hospital Center with the family’s permission to study for evidence of function and rejection. As a result, the surgical and research team, led by Dr. Robert Montgomery, himself a donor heart transplant recipient, were able to obtain critical information about the pig organ after transplantation. “Whole-body donation after death for the purpose of breakthrough studies represents a new pathway that allows an individual’s altruism to be realized after brain death declaration in circumstances in which their organs or tissues are not suitable for transplant.”

On Friday, January 7, Bartley Griffith, MD, Muhammad Mohiuddin, MD, and an extensive team of multi-specialties successfully implanted a genetically modified pig heart obtained from the Revivicor company. Revivicor created the genetically modified pig and hence the heart to the investigators’ specifications. This included modifying ten genes with three knocked out that lead to antibody development and one knocked out that controls the pig organs’ growth. The patient will also receive various anti-rejection drugs plus the monoclonal antibody aimed at CD40.

The patient, a 57-year-old man, was on life support and not eligible for a human donor organ. His projected lifespan was in days to weeks. He understood the risks of the procedure and that it was a first-time human experiment. But as he said before surgery, “It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice… I look forward to getting out of bed after I recover.”

The Food and Drug Administration (FDA,) having reviewed the research data, authorized the procedure “for compassionate use” on New Year’s Eve. As of Tuesday, January 12, the patient was doing well with no evidence of rejection. Only time will tell if he will make a full recovery and have his pig heart perform for many years.

Dr. Griffith is a cardiovascular surgeon with years of experience in transplanting human hearts and lungs. He has been working on xenotransplantation for over a decade. Dr. Mohiuddin joined with Dr. Griffith at the University of Maryland School of Medicine and Medical Center about five years ago to further pursue his research from the National Institutes of Health. He and colleagues developed the initial techniques to prevent rejection by gene modifications and anti-rejection drugs.

Together Griffith and Mohiuddin established the Xenotransplantation Center with Griffith as clinical director and Mohiuddin as scientific director. But, of course, there is a large team, not just the two of them. The Center investigators received a $15.7 million sponsored research grant to evaluate Revivicor genetically-modified pig hearts in further baboon studies. Last week’s surgery was the current culmination of those studies with a first in human heart xenotransplantation.

A new dawn has likely arrived for organ transplantation. But, of course, this was only the first patient. It remains to be seen how effective it will be in this man or how effective it will be in others treated with other genetically engineered pig organs like kidneys, pancreas, or lungs. But without question, it’s an exciting time with transplant-waiting individuals having a new potential on the horizon for returning to a reasonably normal life.

Stephen C Schimpff, MD, MACP, is a quasi-retired internist, professor of medicine, former CEO of the University of Maryland Medical Center, and author of Longevity Decoded — The 7 Keys to Healthy Aging and his co-authored book with Dr. Harry Oken BOOM — Boost Our Own Metabolism

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