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		<title>Purpose at the Center: Craig Martin’s &#8220;Rare&#8221; Commitment to Biopharma and Patients</title>
		<link>https://medika.life/purpose-at-the-center-craig-martins-rare-commitment-to-biopharma-and-patients/</link>
		
		<dc:creator><![CDATA[Gil Bashe, Medika Life Editor]]></dc:creator>
		<pubDate>Wed, 30 Jul 2025 16:01:10 +0000</pubDate>
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		<guid isPermaLink="false">https://medika.life/?p=21348</guid>

					<description><![CDATA[<p>Craig Martin is a strategic chameleon in health innovation. He is equally at home in boardrooms, nonprofit leadership, consulting and advisory roles, all with one guiding force: bringing science closer to patients. My Health Unabashed interview (airing August 11th) with him underscored that every step of his career has been purpose‑driven. From Communications Strategist to Purpose-Built [&#8230;]</p>
<p>The post <a href="https://medika.life/purpose-at-the-center-craig-martins-rare-commitment-to-biopharma-and-patients/">Purpose at the Center: Craig Martin’s &#8220;Rare&#8221; Commitment to Biopharma and Patients</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p><a href="https://www.linkedin.com/in/craig-martin-b915043/">Craig Martin</a> is a strategic chameleon in health innovation. He is equally at home in boardrooms, nonprofit leadership, consulting and advisory roles, all with one guiding force: bringing science closer to patients. My <a href="https://www.healthcarenowradio.com/programs/health-unabashed/">Health Unabashed</a> interview (airing August 11<sup>th</sup>) with him underscored that every step of his career has been purpose‑driven.</p>



<h2 class="wp-block-heading"><strong>From Communications Strategist to Purpose-Built Leader</strong></h2>



<p>Craig began his Boston journey after relocating from Washington, D.C., to join Feinstein Kean Healthcare — a leading consultancy in the life sciences space — as the chosen successor to a founding CEO. There, he furthered his gift for translating scientific and commercial complexity into clear, compelling strategy and narratives. More than a decade later, Feinstein Kean was folded into a holding company, and its name was retired. However, Craig’s Boston roots and passion for guiding life science companies only deepened from there.</p>



<p>Encouraged by his Boston innovation networks, he eventually struck out on his own, founding Rithm Health, a consultancy that advises biotech, digital health, and rare disease companies. It quickly became clear that this wasn’t a sideline gig; it was a mission: supporting companies seeking revenue and impact.</p>



<h2 class="wp-block-heading"><strong>Advisory Leader in the Boston Biopharma Ecosystem</strong></h2>



<p>For some 25 years, Craig has advised early- and mid-stage teams—across health categories—on strategy, business development, communications, and patient engagement. His counsel regularly integrates a responsible business mindset and empathy-infused decision-making, often behind the scenes but profoundly influential.</p>



<p>It’s among the many reasons he was invited onto the board of <a href="https://globalgenes.org/">Global Genes</a> years ago and later extended into advisory roles across rare disease nonprofits and biotech initiatives (including the Fibrolamellar Cancer Foundation).</p>



<figure class="wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio"><div class="wp-block-embed__wrapper">
<iframe title="Global Genes CEO Discusses Partnership with Rare-X" width="696" height="392" src="https://www.youtube.com/embed/g-BMQTDTHuY?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
</div></figure>



<p>Craig’s long-standing volunteerism at Global Genes evolved into formal leadership: he chaired the Corporate Alliance and shaped the organization’s strategy for diagnostic and treatment equity, clinical trial access, and diversity. &nbsp;In 2020, he accepted the role of interim CEO, stepping in at a time of transition purely to serve the rare-disease community. Through the next few years, he helped scale the organization globally while preserving its high-touch culture and mission-aligned focus.</p>



<p>Under Craig, the organization prioritized community capacity-building, integrated, personalized service through RARE Concierge, and connecting patients to diagnosis, trials and support —rather than duplicating work in policy or research. His leadership culminated in the seamless reintegration of RARE‑X, bolstering data sharing and patient-driven research approaches under the Global Genes umbrella.</p>



<h2 class="wp-block-heading"><strong>Launching the Orphan Therapeutics Accelerator</strong></h2>



<p>Craig built on that experience by founding the <a href="https://www.orphantxl.com/">Orphan Therapeutics Accelerator</a> (OTXL) in June 2024. Recognizing that many Phase 1/2 rare disease therapies stall—not from scientific failure, but because of funding or infrastructure gaps—he designed OTXL as a nonprofit biotech that sources shelved ultra‑rare programs and drives them forward through development via Orphan ClinDevNet—a coalition of partners delivering low-cost, AI‑enabled services for clinical trials, manufacturing, regulatory readiness and commercialization.</p>



<p>In the traditional biopharma model, promising compounds are often shelved—not due to scientific failure, but because their potential market size is considered too small to justify the cost and complexity of development. This is especially true in the rare and ultra-rare disease space, where patient populations may number in the hundreds or low thousands.</p>



<p>Larger pharmaceutical companies, focused on ROI and portfolio prioritization, frequently set aside these “orphaned” therapies despite early efficacy signals. Craig recognized that these shelved molecules represented more than business decisions; they represented delayed or denied hope for real patient communities. His insight was to operationalize around these forgotten assets, championing their advancement through an entrepreneurial nonprofit model that combines development efficiency, community partnership, novel commercialization pathways, and mission-driven focus.</p>



<p>By aligning with rare disease advocates and building a collaborative ecosystem, Craig’s Orphan Therapeutics Accelerator brings new life to therapies that might never see the clinic.</p>



<p>Leading Founding Members include Chiesi and BIAL, with operations supported by Landmark Bio, Uncommon Cures®, Viralgen, DVLP Medicines, and Vibe Bio. OTXL aims to be financially self‑sustaining within 4–6 years, reinvesting revenue from commercialized programs to support growing rare disease pipelines.</p>



<p>Though now operating globally, Craig maintains an active advisory presence in Boston’s biotech and healthtech sectors. He contributes strategy, governance insight, and rare-disease expertise to companies and nonprofits—and mentors emerging leaders bridging science, patient advocacy, and enterprise.</p>



<p>He’s also appeared at conferences such as Advanced Therapies USA 2025, reflecting his growing profile in the global gene-therapy and pricing-access discussion space.</p>



<h2 class="wp-block-heading"><strong>What We Can All Learn from Craig’s Journey</strong></h2>



<figure class="wp-block-image size-full"><img data-recalc-dims="1" fetchpriority="high" decoding="async" width="593" height="337" src="https://i0.wp.com/medika.life/wp-content/uploads/2025/07/Craig-Martin.png?resize=593%2C337&#038;ssl=1" alt="" class="wp-image-21349" srcset="https://i0.wp.com/medika.life/wp-content/uploads/2025/07/Craig-Martin.png?w=593&amp;ssl=1 593w, https://i0.wp.com/medika.life/wp-content/uploads/2025/07/Craig-Martin.png?resize=300%2C170&amp;ssl=1 300w, https://i0.wp.com/medika.life/wp-content/uploads/2025/07/Craig-Martin.png?resize=150%2C85&amp;ssl=1 150w" sizes="(max-width: 593px) 100vw, 593px" /></figure>



<p>Craig’s story—spanning executive leadership, consulting firm founding, nonprofit board, interim CEO, and biotech founder—offers five powerful lessons:</p>



<ol class="wp-block-list">
<li>A compelling narrative is a critical component of strategic leadership. Translating complexity into resonance is more than marketing—it shapes how people connect, invest, and act.</li>
</ol>



<ul class="wp-block-list">
<li>Empathy drives innovation. Patient insight isn’t an add-on; it’s the organizing principle of strategy.<br><br></li>



<li>New structures empower neglected science. OTXL’s nonprofit biotech model demonstrates how shelved assets can become viable through purpose-aligned stewardship.</li>
</ul>



<ul class="wp-block-list">
<li>Community builds momentum. Boston’s collaborative ecosystem supported Craig’s leaps—from Feinstein Kean to independent consultancy—amplifying impact.</li>
</ul>



<ul class="wp-block-list">
<li>Purpose provides continuity. Across roles, his north star has remained: bring science closer to patients in sustainable, human-focused ways.</li>
</ul>



<p>Craig Martin reflects what I’ve learned about leadership in health innovation: that proximity—to patients, communities, and complexity—makes the difference. As he told me during our conversation: <em>“The science is often there. The challenge is translation—moving from discovery to delivery.”</em></p>



<p>In every role, in Boston and beyond, Craig is focused on that translation—one program at a time, one community at a time—with purpose at the center.</p>
<p>The post <a href="https://medika.life/purpose-at-the-center-craig-martins-rare-commitment-to-biopharma-and-patients/">Purpose at the Center: Craig Martin’s &#8220;Rare&#8221; Commitment to Biopharma and Patients</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">21348</post-id>	</item>
		<item>
		<title>US -India Health Partnerships: A Blueprint for Global Health Innovation</title>
		<link>https://medika.life/us-india-health-partnerships-a-blueprint-for-global-health-innovation/</link>
		
		<dc:creator><![CDATA[Aman Gupta]]></dc:creator>
		<pubDate>Tue, 10 Dec 2024 21:17:02 +0000</pubDate>
				<category><![CDATA[Digital Health]]></category>
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		<category><![CDATA[India]]></category>
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		<guid isPermaLink="false">https://medika.life/?p=20519</guid>

					<description><![CDATA[<p>India’s rapidly evolving health sector and the U.S.’s unparalleled expertise in innovation and investment create a powerful synergy for collaboration.</p>
<p>The post <a href="https://medika.life/us-india-health-partnerships-a-blueprint-for-global-health-innovation/">US -India Health Partnerships: A Blueprint for Global Health Innovation</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p>As the United States transitions through another pivotal election cycle, the impact of its political decisions reverberates across the globe—especially for key allies like India. In the realm of health, where innovation, access, and policy shape billions of lives, the U.S.-India partnership stands as a cornerstone of global progress. With both nations poised to leverage their strengths, the next phase of their collaboration could redefine global health, offering unparalleled opportunities for multinational corporations (MNCs) and the broader health ecosystem.</p>



<h2 class="wp-block-heading"><em>A Changing Landscape: Opportunities in U.S.-India Health Ties</em></h2>



<p>India’s rapidly evolving health sector and the U.S.’s unparalleled expertise in innovation and investment create a powerful synergy. India, already a global leader in pharmaceuticals, supplies 40% of generics to the U.S. and has emerged as a hub for cutting-edge manufacturing and research. Meanwhile, U.S. companies view India as a gateway to growth, with its burgeoning middle class, aging population of over 100 million, and a health market projected to reach $638 billion by 2025, growing at a 22% compound annual growth rate. The results of U.S. elections will directly influence health policies, including tariffs, trade agreements, and investment incentives, shaping the pace of collaboration between the two nations. Multinationals must navigate these shifts carefully, balancing policy changes with market potential.</p>



<h2 class="wp-block-heading">Emerging Trends in the US-India Health Partnership</h2>



<p>Reshaping the Pharmaceutical Supply Chain: With the U.S. increasing tariffs on Chinese imports and emphasizing domestic resilience, India has an unprecedented opportunity to fill the gap. Proposed legislation like the U.S. BIOSECURE Act positions India as a vital partner in contract manufacturing and research, doubling opportunities for Indian CDMOs and CROs.&nbsp;</p>



<p>Incentivizing Innovation and Local Production: India&#8217;s Production Linked Incentive (PLI) and Make in India initiatives are revolutionizing domestic manufacturing. These schemes offer MNCs financial incentives to produce locally, reducing costs and enhancing access. U.S. companies like Pfizer and GSK have already capitalized on India’s pro-business policies, paving the way for others to follow.</p>



<p>Digital Health Revolution: India’s National Digital Health Mission and growing investments in telemedicine present lucrative opportunities for U.S. firms. Collaborating with India’s thriving tech ecosystem could help MNCs expand their digital health solutions, from AI-driven diagnostics to telehealth platforms, addressing unmet needs in rural and underserved markets.</p>



<p>Medical Devices as the Next Frontier: India’s recent ₹500 crore initiative to strengthen its medical devices sector aligns with U.S. expertise in advanced technologies. Partnerships in this space could make India a global exporter of high-quality medical devices, with MNCs playing a pivotal role in innovation and scale.</p>



<h2 class="wp-block-heading">Why India is Unmissable for Multinationals</h2>



<p>India’s health sector is undergoing a profound transformation, bolstered by government-led reforms and a favorable FDI regime. The allowance of 100% foreign direct investment through automatic routes in health and related sectors has already attracted global giants. Regulatory relaxations, such as waiving clinical trial requirements for drugs approved in select countries, make India an even more attractive destination for innovation. Additionally, India’s ambitious BIO-Ride Scheme aims to bridge the gap between research and commercialization, enhancing the country’s reputation as a biomanufacturing powerhouse. These developments, coupled with the expanding talent pool, provide multinationals with access to skilled professionals and cutting-edge research.</p>



<p>While the U.S.-India health partnership offers immense promise, challenges such as regulatory hurdles, intellectual property concerns, and geopolitical shifts must be addressed. Multinationals must adopt a strategic approach to align their goals with India’s priorities, from affordability to local capacity building. The future of health lies in the strength of the U.S.-India relationship. Together, the two nations can drive transformative change, addressing global health challenges through innovation, policy alignment, and mutual investment. Multinationals that recognize and act on this potential will not only unlock significant growth but also play a defining role in shaping the health landscape for generations.</p>



<p>As the post-election dust settles, one thing is clear: the U.S.-India health partnership is not just a bilateral opportunity—it’s a global imperative.</p>
<p>The post <a href="https://medika.life/us-india-health-partnerships-a-blueprint-for-global-health-innovation/">US -India Health Partnerships: A Blueprint for Global Health Innovation</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">20519</post-id>	</item>
		<item>
		<title>Walgreens Launches Clinical Trial Business to Address Industrywide Access and Diversity Challenges and Redefine Patient Experience</title>
		<link>https://medika.life/walgreens-launches-clinical-trial-business-to-address-industrywide-access-and-diversity-challenges-and-redefine-patient-experience/</link>
		
		<dc:creator><![CDATA[Medika Life]]></dc:creator>
		<pubDate>Fri, 17 Jun 2022 02:53:28 +0000</pubDate>
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		<guid isPermaLink="false">https://medika.life/?p=15427</guid>

					<description><![CDATA[<p>Walgreens today announced the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. </p>
<p>The post <a href="https://medika.life/walgreens-launches-clinical-trial-business-to-address-industrywide-access-and-diversity-challenges-and-redefine-patient-experience/">Walgreens Launches Clinical Trial Business to Address Industrywide Access and Diversity Challenges and Redefine Patient Experience</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p>Walgreens today announced the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreens flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.</p>



<p>The introduction of Walgreens clinical trial offerings coincides with recent steps taken by the U.S. Food and Drug Administration to increase racial and ethnic diversity in clinical trials given 20 percent of drugs have a variation in responses across ethnic <a href="https://doi.org/10.1002/cpt.61">groups<sup>1</sup></a>, yet 75 percent of clinical trial participants are white, while only 11 percent are Hispanic and fewer than <a href="https://www.fda.gov/media/145718/download">10 percent are Black and Asian<sup>2</sup>.</a></p>



<p>“Walgreens trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable,” said Ramita Tandon, chief clinical trials officer, Walgreens. “Through the launch of our clinical trials services, we can provide another offering for patients with complex or chronic conditions in their care journey, while helping sponsors advance treatment options for the diverse communities we serve. This is yet another way we are building our next growth engine of consumer-centric healthcare solutions.”</p>



<p>Patient recruitment and enrollment remain challenges in clinical trials, further exacerbated by the COVID-19 pandemic. Nearly 80 percent of trials fail to meet their enrollment goals in the stated timeframes, often contributing to costly delays.<sup>  </sup>Walgreens is addressing these challenges and improving the overall clinical trial experience by rapidly scaling three portfolio-integrated, patient-centric service lines:</p>



<ul class="wp-block-list"><li>With Walgreens patient reach and access to an extensive foundation of pharmacy and patient-authorized clinical data, the company can proactively match diverse patient populations to trials across a range of disease areas based on race, gender, socioeconomic status and location. By leveraging a tech-enabled approach to patient identification and creating a large registry of clinical trial participants, Walgreens will reduce the time it takes to match eligible patients to clinical trials.</li></ul>



<ul class="wp-block-list"><li>Walgreens is addressing access barriers through a compliant, validated and secure decentralized clinical trial platform built on a rigorous compliance and regulatory framework to ensure patient privacy and security. This approach leverages owned and partner digital and physical assets, including select Health Corner and Village Medical at Walgreens locations, to directly engage patients at home, virtually or in-person. Synergies with AllianceRx Walgreens Pharmacy, as well as investments made by Walgreens Boots Alliance in CareCentrix and Shields Health Solutions, will also support new clinical trials approaches, particularly for specialty indications. This innovative operating model will accelerate patient searches, simplify workflow and enable a faster and more representative collection of trial data.</li></ul>



<ul class="wp-block-list"><li> Walgreens is building on a legacy of delivering high-quality, real-world evidence to unlock value in therapeutics and help improve health outcomes. Through a robust foundation of real-world insights, Walgreens can support sponsors’ drug development strategies, inform clinical trial designs, optimize trial execution and improve diversity in trials. In fact, real-world insights delivered through the <a href="https://www.walgreens.com/businesssolutions/covid-19-index.jsp">Walgreens COVID-19 Index</a> helped inform national and local health decisions and plans.</li></ul>



<p>More than half of Walgreens nearly 9,000 stores are located in socially vulnerable areas. When combined with Walgreens customer relationships, digital offerings that keep patients connected to care and partnerships with national and local organizations, Walgreens has a proven ability to break down barriers to health engagement and access among diverse patient populations. Most recently, the company hosted vaccine clinics and events to address vaccine hesitancy with help from more than 750 diverse, community-based partners, and administered approximately 40 million COVID-19 vaccines to underserved communities throughout the pandemic.<br><br><strong>Pluto Health™ Collaboration Enhances Experience With Comprehensive Health Insights</strong></p>



<p>One of the partners for the Walgreens expanded healthcare offering will be Pluto Health, a multi-layered, smart care coordination service that unifies siloed health information from multiple places (such as medical records, social determinants of health, insurance claims and more) within 30 minutes. The Pluto Health team then evaluates patient health information with the recommended clinical care guidelines and social determinants of health data to identify and close any potential gaps in care. This helps ensure every patient receives the best possible care through up-to-date screenings, vaccinations and other health interventions, such as clinical research as a care option.<br><br> “Pluto Health was co-created within the healthcare community to make the provision of care achievable and more equitable for more people with better care coordination,” said Joy Bhosai, MD MPH, Co-Founder, CEO Pluto Health. “As a part of our primary goal to coordinate care and support patients on their terms, we are thrilled to play a part in making the latest medical advances more accessible. It’s time to accelerate healthcare access for all patients, from all walks of life, and from anywhere in the nation.”<br></p>
<p>The post <a href="https://medika.life/walgreens-launches-clinical-trial-business-to-address-industrywide-access-and-diversity-challenges-and-redefine-patient-experience/">Walgreens Launches Clinical Trial Business to Address Industrywide Access and Diversity Challenges and Redefine Patient Experience</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">15427</post-id>	</item>
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		<title>No Hope for Older Patients in Cancer Clinical Trials Thanks to Bias</title>
		<link>https://medika.life/no-hope-for-older-patients-in-cancer-clinical-trials-thanks-to-bias/</link>
		
		<dc:creator><![CDATA[Pat Farrell PhD]]></dc:creator>
		<pubDate>Thu, 16 Jun 2022 21:12:13 +0000</pubDate>
				<category><![CDATA[Cancers]]></category>
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		<guid isPermaLink="false">https://medika.life/?p=15424</guid>

					<description><![CDATA[<p>Hope is one thing that can keep patients alive, but when older cancer patients are not even considered for clinical trials, how can they maintain hope?</p>
<p>The post <a href="https://medika.life/no-hope-for-older-patients-in-cancer-clinical-trials-thanks-to-bias/">No Hope for Older Patients in Cancer Clinical Trials Thanks to Bias</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p id="ee66"><em>All life is precious; understandably</em>, resources for clinical trials of many illnesses like cancer may be limited. Does eliminating older patients from these trials add to our clinical knowledge? I would offer that it doesn’t because a trial unless limited for a valid research reason to one set of patients, is flawed by a design that eliminates the elderly or older patients.</p>



<p id="3f0d">There are&nbsp;<a href="https://www.healthknowledge.org.uk/public-health-textbook/research-methods/1a-epidemiology/methods-of-sampling-population" rel="noreferrer noopener" target="_blank">specific types of sampling</a>&nbsp;for clinical trials or any research, and they are&nbsp;<a href="https://www.statisticshowto.com/probability-and-statistics/statistics-definitions/simple-random-sample/" rel="noreferrer noopener" target="_blank">random</a>,&nbsp;<a href="https://en.wikipedia.org/wiki/Systematic_sampling" rel="noreferrer noopener" target="_blank">systematic</a>,&nbsp;<a href="https://en.wikipedia.org/wiki/Stratified_sampling" rel="noreferrer noopener" target="_blank">stratified</a>,&nbsp;<a href="https://www.simplypsychology.org/cluster-sampling.html" rel="noreferrer noopener" target="_blank">clustered</a>, and&nbsp;<a href="https://www.sciencedirect.com/topics/computer-science/convenience-sampling#:~:text=Convenience%20sampling%20is%20the%20most,a%20location%20or%20Internet%20service." rel="noreferrer noopener" target="_blank">convenience sampling</a>, and the sampling type may result in older patients being excluded. There are other types of sampling, but these are the more usual. Convenience sampling is one where it is probably easiest to get the sample size required.</p>



<p id="495d">Of course, each clinical trial will also, in addition to their sampling method, have&nbsp;<a href="https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials" rel="noreferrer noopener" target="_blank">rule-in and rule-out criteria eligibility</a>. Here, the principal investigator makes decisions based on factors they wish to control, such as a history of alcoholism, familial sudden death syndrome, or other medical conditions.&nbsp;<em>Age can be an important concern and serve as a “rule-out.</em>”</p>



<p id="9331">Of course,&nbsp;<a href="https://en.wikipedia.org/wiki/Institutional_review_board" rel="noreferrer noopener" target="_blank">institutional review boards</a>&nbsp;bear responsibility here, too. Questioning by board members regarding the reason for not including older patients is mandatory.</p>



<p id="1307">Every patient has the potential to bolster our knowledge and research base if we see past our bias. And what would a specific bias be in these cases? Are we&nbsp;<em>selecting in&nbsp;</em>only those who have many decades of life left and tossing aside those with possibly one decade of life left to them? How much is a decade of life worth these days?</p>



<h2 class="wp-block-heading" id="065b">The Ethos of Medical Ethics</h2>



<p id="636e">Clinical research trials are essential for any headways to be made in the many wars medical science is currently engaged in worldwide for various diseases. It would stand to reason that these research trials would be comprised of individuals of all ages, ethnicities, and gender groups to ensure that we are utilizing a representative sample to come to valid results. But that doesn’t seem to be the case with two groups, particularly older adults and Black individuals.</p>



<p id="1946">Regarding Black individuals, we know a long history has contributed to a reluctance to engage in clinical trials. No one needs to tell us about the&nbsp;<em>horrific trials in the South with Black men</em>&nbsp;who thought they were being treated for a sexually transmitted disease (<a href="https://www.mayoclinic.org/diseases-conditions/syphilis/symptoms-causes/syc-20351756#:~:text=Syphilis%20is%20a%20bacterial%20infection,membrane%20contact%20with%20these%20sores." rel="noreferrer noopener" target="_blank">syphilis</a>) when, in fact, they were being followed to catalog the progression of the disease and their deaths. They never received the medicine that would have cured them, penicillin.</p>



<p id="f082"><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4354806/" rel="noreferrer noopener" target="_blank"><em>Despite mandates</em></a><em>&nbsp;by the federal government to ensure the inclusion of women and minorities in all federally funded research, African Americans continue to participate less frequently than Whites. Lower participation rates among African Americans have been reported across various study types (e.g., controlled clinical treatment trials, intervention trials, as well as studies on various disease conditions, including&nbsp;</em><strong><em>AIDS, Alzheimer’s disease, prostate cancer, and other malignancies, stroke, and cardiovascular disease</em></strong><em>).</em></p>



<p id="ea10">Medical history must always keep that in the record books and understand the impact it has had on generations of Blacks. There are other examples of&nbsp;<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4354806/" rel="noreferrer noopener" target="_blank">equally unethical research</a>&nbsp;or experiments on this group.</p>



<p id="7d5f">Now, we face another difficulty or impediment, and that is in the area of age disparities in some clinical trials, but cancer is of utmost importance.</p>



<h2 class="wp-block-heading" id="e2b9">Cancer and the Aged Patient</h2>



<p id="65e1">Statistical census data released annually by major research entities indicate that 10% of those over the age of 65 have some form of cancer. The&nbsp;<a href="https://www.census.gov/newsroom/stories/older-americans-month.html" rel="noreferrer noopener" target="_blank">latest census figures for the United States</a>&nbsp;suggest that there are over 65 million people in this age group, both male and female. Logically, this indicates almost seven million in that group have cancer.</p>



<p id="8ba8"><a href="https://www.who.int/news-room/fact-sheets/detail/cancer" rel="noreferrer noopener" target="_blank">Worldwide the World Health Organization</a>&nbsp;indicates that each year 10 million people die from cancer worldwide, or one in six. In the US, in the 60–70-year-old group, cancer is the second most common cause of death.</p>



<p id="c4eb">The FDA has noted an&nbsp;<a href="https://fda.report/media/109652/Enrollment-of-older-adults-in-Cancer-clinical-trials---US-Food-and-Drug-Administration-Experience.pdf" rel="noreferrer noopener" target="_blank">underrepresentation of older adults</a>&nbsp;in cancer-treatment trials. The National Cancer Institute’s data show decreasing enrollment in trials both FDA and&nbsp;<a href="https://seer.cancer.gov/" rel="noreferrer noopener" target="_blank">SEER</a>&nbsp;with advancing age. At ages 75 and greater, only 9% of research samples were in this age group. At 65, it was 36%.</p>



<p id="ea8b">By 2030, it is estimated that&nbsp;<em>70% of people over 65&nbsp;</em>will have some form of cancer. If that isn’t a compelling reason to begin enrolling this population into cancer clinical trials, I have to question the trials.</p>



<h2 class="wp-block-heading" id="69e7">Arrogance and Ignorance in Research</h2>



<p id="8c31">I have to question the&nbsp;<em>rationale for the trials, who is underwriting the trials, the background of the principal investigator in terms of ageism potential, and how significant the trials would be</em>&nbsp;in a rapidly aging world. We cannot deny that the&nbsp;<a href="https://en.wikipedia.org/wiki/The_Silver_Tsunami" rel="noreferrer noopener" target="_blank">silver tsunami</a>&nbsp;is upon us and will require billions of dollars of care for these patients.</p>



<p id="056f">If we do nothing or little to provide innovative, new treatments garnered from new research, we will find ourselves trying to swim without any floaties to support us.</p>



<p id="e896">One research paper indicated that if we fail to include this population in cancer clinical trials, there will be a lack of generalizability that can lead to&nbsp;<em>challenges in treatment decisions for OA (older adults) and concerns regarding health inequity</em>. Do older adults receive equal medical treatment today? I question that.</p>



<p id="dcde">The editors indicated that&nbsp;<em>trial structure, design, physician perspective, and patient or caregiver perspectives</em>&nbsp;must be carefully evaluated and included as required. They call for actionable recommendations to address the challenges these types of cancer trials face, which may have been ignored in the past.</p>



<p id="8968">There is no room for ageism in clinical research, and when found, it must be addressed as strongly as possible because lives are on the line. To do less is extreme arrogance and ignorance in the face of what is coming down the road. No gods are working in medicine, and everyone must adhere to the strictest ethical guidelines possible and care for those who may have, either on purpose or thoughtlessly, fallen through the safety net.</p>



<p id="1131">Yes, I have heard chiefs of service refer to older patients as&nbsp;<a href="https://acronym24.com/pia-meaning-in-medical-slang/" rel="noreferrer noopener" target="_blank">PIA</a>s (no, it’s not Prolonged Infantile Apnea), a term which should have been erased from medicine many decades ago but is still held close in the minds of those who live in the past.</p>
<p>The post <a href="https://medika.life/no-hope-for-older-patients-in-cancer-clinical-trials-thanks-to-bias/">No Hope for Older Patients in Cancer Clinical Trials Thanks to Bias</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">15424</post-id>	</item>
		<item>
		<title>The Scary Reality of Modern Healthcare</title>
		<link>https://medika.life/the-scary-reality-of-modern-healthcare/</link>
		
		<dc:creator><![CDATA[Charles Black]]></dc:creator>
		<pubDate>Thu, 02 Jun 2022 04:04:06 +0000</pubDate>
				<category><![CDATA[Breaking Research]]></category>
		<category><![CDATA[Cardiovascular]]></category>
		<category><![CDATA[Coronavirus]]></category>
		<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Editors Choice]]></category>
		<category><![CDATA[For Doctors]]></category>
		<category><![CDATA[General Health]]></category>
		<category><![CDATA[Healthcare]]></category>
		<category><![CDATA[Policy and Practice]]></category>
		<category><![CDATA[Public Health]]></category>
		<category><![CDATA[Charles Black MD]]></category>
		<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Drug Dvelopment]]></category>
		<category><![CDATA[Reearch]]></category>
		<category><![CDATA[Science]]></category>
		<category><![CDATA[Treatments]]></category>
		<category><![CDATA[vaccines]]></category>
		<guid isPermaLink="false">https://medika.life/?p=15291</guid>

					<description><![CDATA[<p>We often don’t know what we are doing, but we can’t stop. Science and research never stop.</p>
<p>The post <a href="https://medika.life/the-scary-reality-of-modern-healthcare/">The Scary Reality of Modern Healthcare</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
]]></description>
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<p id="476d">A famous heart surgeon was waiting for his car at the dealer when a mechanic recognized him.</p>



<p id="25f5">The cheeky mechanic waved the surgeon over and pointed to the mechanic’s work. He showed the famous surgeon how the repairman replaced worn hoses and leaky valves. The mechanic pointed to his work, “Look, you and I do the same work. So why do you get paid the big bucks to do the same job?”</p>



<p id="4d44">The surgeon inspected the mechanic’s efforts, then turned to the repairman and whispered, “Try doing it while the car is running.”</p>



<p id="4bfd">I don’t know how accurate this story is, but the underlying truth remains, working in healthcare means working on a car while it’s running. We don’t have the luxury of turning off our problems and putting them in the corner until a perfect solution is devised or a replacement part arrives. We have to work in a living system while it is running and with only the things available to us at the time.</p>



<p id="13ee">The Coronavirus pandemic demonstrated this truth of medicine to people who had not seen it before. Not that it is a new problem, but that people outside of doctors and some patients exposed to the realities of modern medicine.</p>



<p id="84f8">When the patients first started arriving in hospitals with this novel infection, we did not know how to treat it. We had good practices for treating similar illnesses, but no one had ever treated this virus before. We were in uncharted territory.</p>



<p id="cd7d">It would have been nice if we had the luxury of a few years to study the virus and its effects and better target our response. We would have seen fewer missteps. But while patients in respiratory distress piled up in the ICU, we did not have the luxury of time. We needed to treat these people now.</p>



<p id="8e9a">You could say mistakes were made, but that’s not really fair. Calling something a mistake means that we knew the correct answer. But medicine is not high-school algebra. While two plus two always equals four in math class, the calculus of biology is much more complex. What works on the cellular level does not always transfer into a living organism’s much more complex chemistry and biology. The interaction of organs, hormones, the immune system, and medical therapy is a maze with many dead ends.</p>



<p id="8a8b">So medicine did its best, but it did not get the response right. We tried medications and treatments that failed, not because they were a bad idea, but because the body has its own logic. A logic that sometimes defies our ability to predict. We tried the things that made sense based on what we knew and then waited to see what the results were. And some of those results were . . . disappointing.</p>



<p id="1959">Medications that showed promise in a petri dish showed no effect and possibly caused harm when given to infected patients. Old rules for dealing with patients in respiratory distress, like the early use of ventilators, proved to be suboptimal in the care of patients with COVID. So doctors noted these results and adjusted treatment as they went.</p>



<p id="022a">Our only choice was to learn how best to treat patients as we went along. Medicine did not have the luxury of waiting until the laboratory had rigorously tested the treatment options because patients didn’t have the luxury of waiting. It would have been unethical not to do our best to care for people as best we knew how even when we knew our knowledge was lacking.</p>



<p id="41fc">People have expressed concern about how quickly pharmaceutical companies developed a new vaccine. I will admit, it is impressive how quickly we had several options. But saying it happened that fast is an oversimplification. The underlying research in vaccines has been ongoing for decades. That long history of research performed behind the scenes made these vaccines possible. They aren’t really new vaccines; they are a new extension of research that has been going on for decades in preparation for a scenario like COVID-19.</p>



<p id="91ee">Were these vaccines rushed into use? Many feel they were not adequately tested, and if they mean we don’t have years of data on the vaccine’s long-term effect, then those critics are correct. Medicine had to run studies to establish that the vaccine was effective and safe in the limited time they had. The only way to find out the ten-year treatment results is to wait ten years and see what happens, but we didn’t have ten years to wait. People were dying, and we needed a good way to stop that now, not a perfect way to do it in ten years.</p>



<p id="b44b">Everyone would like to know the twenty-year effects of a treatment before they start it. But I can tell you from experience that when the current therapy has failed, that experimental treatment — despite all its unknown — starts to look pretty enticing. The patient dying from cancer today can’t wait twenty years to determine the long-term effects of a new treatment. They need to make a decision today with the imperfect available data and hope for the best.</p>



<p id="f8e1">The problem is we have to treat people and problems as they appear. That often means initiating treatment before we know all the facts. The body and the healthcare system are dynamic. Doctors and nurses work on the car while it’s running and without access to spare parts.</p>



<p id="b8c9">I spent time on a farm when I was growing up. I learned that when it is harvest time and an essential piece of equipment breaks, you can’t wait a week for a new part to arrive. When the new part arrives, it will be too late, and the crop will be lost. So if you can’t beg, borrow, or steal help from a neighbor, you have to find a way to limp through with a homemade baling wire and duct tape solution. When you find yourself in this situation, you get creative and invent a solution. The one thing you are not allowed to do is give up.</p>



<p id="9609">Healthcare providers did not give up. Despite having no effective medications, tested treatment plans, vaccines, or even the personal protective equipment to keep themselves safe, healthcare workers soldiered on. They kept showing up, working on the problem, and learning as they went along. And yes, they created more than a few baling wire and duct tape solutions to try and help their patients. The first efforts were not as effective as we would have liked. There were missteps, blind alleys, and some advice that seemed wise but proved to be ineffective in the long run. That is what happens when you work on a novel problem in uncharted territory.</p>



<p id="dc86">When you think about it, all advances in medicine occur in uncharted territory. We constantly create new treatments for problems, new medications, surgeries, technologies, and implantable devices. So the unknown territory is not new to medicine. The medical system has more tools and knowledge than ever before, but we don’t have perfect tools or expertise, and we never will.</p>



<p id="dce7">The COVID pandemic showed us both the power of modern medical science and the ingenuity and resilience of healthcare providers. The pandemic also demonstrated the limitations of what we can know and do. The only way to find out the long-term results of a medical treatment or vaccine is to wait decades. But while we wait, people die. We find that unethical, so we do the best we can with the knowledge and tools we have at our disposal while working to sharpen those tools and build a better understanding.</p>



<p id="5e53">Doctors don’t have the luxury of turning off the ignition and working on a problem while it sits quietly and waits for us. We have to try and repair the car while it is running, but we must all accept that we will never be perfect.</p>
<p>The post <a href="https://medika.life/the-scary-reality-of-modern-healthcare/">The Scary Reality of Modern Healthcare</a> appeared first on <a href="https://medika.life">Medika Life</a>.</p>
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