This move benefits Indian patients and has the potential to reshape the global pharmaceutical landscape. With India’s new policy, many multinational biopharmaceutical companies will need to reflect on how India evolves into a priority market.  

Speaking on the decision, Dr. V.G. Somani, Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization, stated, “This policy shift is designed to bring the best of global medical innovation to India more swiftly. By relying on the robust data from international trials, we can ensure that Indian patients benefit from these advancements without unnecessary delays.”

This is more than just a regulatory update for multinational biopharmaceutical companies—it’s a strategic inflection point. India has long been considered a market of interest due to its significant population, favorable policy environment, and emerging middle class. Now, it has signaled its readiness to engage with the global pharmaceutical ecosystem on a new level.

The shift opens up a new market for these pharma companies. It presents an opportunity, but more importantly, a responsibility to extend their voice in India, increasing corporate brand reputation, science communication, and patient advocacy. It’s a turning point that could redefine the global pharmaceutical landscape, underscoring the weight of their role in shaping the future of healthcare.

S. Rajan, Chief Communications, Corporate Affairs and CSR officer at Roche, is among the industry leaders who applauded the GoI news: “This circular is a welcome and much-needed move. The calling out of specific drug categories will help drive a uniform and consistent understanding and avoid any delays. It is important that this is implemented well. We are hopeful that access to the latest innovations will be expedited, addressing unmet healthcare needs and benefitting Indian patients.”

Eliminating the cost barrier of conducting local clinical trials indicates that the GoI is seeking to address a public health need.  One obstacle has been removed, though others remain. Global biopharma companies still face significant challenges operating in India, primarily due to price controls impacting innovative therapies. At this time, India’s government enforces price caps that too often make it financially unviable for multinational companies to launch new, innovative drugs in this market. But it’s not impossible!

This is a favorable move to bring innovative cancer therapies and treatments for rare diseases to people in India. This remains a market of incredible potential, and biopharma companies will need to continue advancing innovative therapies and supporting them with economic solutions to make the best medicines available to more people worldwide. In the meantime, an expansion strategy to India is a medical and communication priority.

Investing in Corporate Brand Reputation

With India becoming a priority market, global pharmaceutical companies must assess how to build relationships with India’s medical and patient advocacy communities.  This is more than relying on marketing muscle. It’s about establishing a reputation as a trusted partner in health innovation and delivery in fast-emerging nations. This could involve initiatives such as collaborating with local healthcare providers, supporting patient education programs, and participating in policy discussions on health innovation and delivery in India.

Even before the GoI decision, the Indian pharmaceutical market was expected to grow to US$130 billion by 2030, up from US$42 billion in 2021, making it one of the fastest-growing health markets in the world.  The decision to embrace other nations’ regulatory moves will likely dramatically accelerate that growth.

Patrizia Cavazzoni, MD, Center for Drug Evaluation and Research, at FDA, has long tracked GoI decisions: “India’s decision to align its drug approval processes with global standards is a significant step that will foster greater collaboration. It also highlights the need for pharmaceutical companies to engage more deeply with Indian stakeholders, ensuring their corporate presence is synonymous with trust and transparency.”

Like audiences everywhere, the Indian public is increasingly discerning the corporate behaviors of those they entrust with their health.  People with urgent health concerns are excited about this decision, which will speed up access to therapies.  Companies must recognize that investing in world-class science may not be enough in the post-COVID era to secure physician support and consumer confidence.  To facilitate market entry in India requires establishing corporate identities people can trust.

The Imperative for Science-Based Communication

Effective science communication will be paramount as these companies introduce their health innovations into India. The complexities of advanced medical treatments, particularly newly approved ones, require careful explanation to health providers and the public.

Transparent, accessible communication will help demystify these innovations, fostering greater acceptance and understanding.  This also calls on major hospital provider systems that served as drug trial sites for these regulatory-approved medicines to step forward and share clinical backgrounds and best practices in patient care.

According to published studies, 87% of Indian physicians are highly engaged in continuing medical education (CMEs) and are keen to stay updated with the latest advancements in treatments and drug safety protocols, highlighting a receptive audience for apparent, data-driven communication efforts. Companies have an opportunity to lead by example, demonstrating that they are bringing innovative products to market by showing commitment to educating and empowering Indian patients and health professionals.

Dr. V.G. Somani, DCGI, emphasized the importance of clear communication in this new regulatory landscape: “Pharmaceutical companies must now rise to the challenge of effectively communicating the science behind these treatments to healthcare providers and patients. This will be crucial in ensuring that the benefits of these new therapies are fully realized.”

Patient Advocacy as a Pillar of Reputation

Most crucially, multinational pharmaceutical companies must prioritize patient advocacy in India. The recent regulatory change will undoubtedly bring some innovative treatments to the market. The policy change is a catalyst toward ensuring treatments are accessible, affordable, and aligned with patients’ needs.  However, it remains a complex challenge.  India has 1.4 billion people – as many as 400 million classified as middle class – and a diverse and complex healthcare insurance system that includes government, private, and, in some cases, a heavy reliance on consumer out-of-pocket payments.

Companies must engage with patient communities, understand their unique challenges, and advocate for solutions that address them. Organizations such as the Organization for Rare Diseases India (ORDI) and the Lysosomal Storage Disorders Support Society (LSDSS) are among the advocacy groups advocating for patients with rare diseases in India. ORDI ensures early diagnosis, treatment, and support for individuals with rare diseases, while LSDSS focuses on increasing awareness and providing access to therapies for lysosomal storage disorders.

Dr. Manjit Singh, LSDSS Executive Committee President, commented on the significance of this regulatory change: “This policy decision is a critical step forward for patients with rare diseases in India. It will help bring much-needed therapies to the market faster. Still, it also places the onus on pharmaceutical companies to ensure these treatments are accessible and affordable for all patients.”

By engaging with these patient advocacy groups, pharmaceutical companies can help amplify patients’ voices, ensuring their needs are central in developing and distributing new treatments. Over time, this will include ensuring peer-reviewed science is shared with India-based media covering health and science, prioritizing pricing strategies to ensure accessibility to patient support programs, and investing in awareness efforts so that people with these conditions understand the importance of medication adherence.

The Government of India’s decision to waive local clinical trial requirements for drugs approved by gold-standard regulatory bodies is forward-thinking and aligns with the country’s demonstrated efforts to improve health delivery for serious illnesses. Multinational biopharmaceutical companies should get the signal that India is a welcoming market ready to be at the forefront of their phyician education and patient advocacy efforts. By investing in corporate brand awareness, scientific communication, and patient advocacy, these companies can contribute meaningfully to the health and well-being of India and other emerging nations. 

One barrier to access has been lowered for innovative cancer and rare disease therapies.  In reality, others remain.  One of the biggest is that the Indian National Pharmaceutical Pricing Authority sets ceiling prices – caps – that include certain patented and innovative drugs. The pricing formula often uses a cost-plus approach, a non-starter for significant biopharma companies championing breakthrough therapies in a price-referring policy environment.  But the door to possibilities has opened wider.

In responding to the GoI welcoming decision with action, the biopharmaceutical industry can reinforce its commitment to good business, science, and patient care—a true win-win-win for all involved and a global health impact. The message is clear: Pharma companies consider the possibilities and  “Go to India!”

The post India’s Pivotal Regulatory Shift: A Possible Game-Changer in Expediting Medicines to Millions in Dire Need appeared first on Medika Life.

Managing disease has become the well trodden path to providing those profits.

To paint pharma as the only black sheep in the healthcare family would however be grossly unfair, as insurers and other Shylock’s have smelled the blood in the water and have been circling and feeding for decades. If we however, as patients, represent the fish in the water, pharma is guilty of providing the worms industry bait their hooks with.

How many people reading this article can open their medicine cabinet and produce one or more drug they have been prescribed in the last decade that comes with a repeat prescription – for life! I’d hazard it would be more than half the readers. Healthcare is no longer trying cure you, and probably stopped trying decades ago. Right around the time the penny dropped.

A healthy, cured cow is no longer a cash cow. Long term management became the new catchphrase of medicine.

A change in tack

The mechanics that underpin this shift in care are incredibly transparent and from a physiological point of view, also simpler to manage. It is far easier interfering on a daily basis with the production of, say, excess stomach acid in someone who suffers from gastritis, than it is to address and correct the underlying cause of the excess acid. I should know, I take a daily dose of Omeprazole for exactly this.

While the package insert suggests the medication should not be used for longer than 10 days (covering the manufacturer) some doctors prescribe these for life. Who, I wonder, when the dust settles in the industry, will be held legally liable for off-label use. I’d suggest to the prescribing doctors that it wont be the manufacturers.

Almost every drug we now manufacture falls prey to off-label use or use way beyond its intended, approved and clinically trialed, prescribed use.

Aspirin is ingested daily by millions around the globe in the hopes it will offer some form of protection against cardiac events and clotting. Statins are prescribed for life, to control bad cholesterol and soften your arteries. Ozempic, a drug containing semaglutide to manage insulin in diabetics is now being used off-label for weight management. To keep the weight off, you’re obliged to use it for life.

How does Ozempic affect a healthy patient population that does not suffer with diabetes? No one knows, as the long term use of the drug has not been tested in this patient population. Why would you bother? To be clear, the doctor signing your script doesn’t have a clue either. In the cold light of day, he is taking an unethical medical risk prescribing an off-label drug to you, one you may very well require for life.

We know, and your doctor is all to well aware of this, that exercise and a healthy diet can potentially replace most of the drugs you pay for each month. Drugs that are supposed to buy you the time to implement healthy changes in your lifestyle are now being used to chain you to the wheel of never ending “health” dependency.

An expensive habit, with drugs like Ozempic retailing for around $1500 a shot. The price has skyrocketed as vanity has boosted demand for the drug, leaving patients with actual diabetes, who have a real need for the medicine, unable to find or afford it.

So ingrained has this “continued use” policy become, in both the minds of healthcare and patients, that even the vaccines we now manufacture, are subject to it. Booster shot after booster shot.

Problems abound

There are of course multiple and often serious consequences of practicing medicine this way, a few of which are outlined in brief below;

• Off-label use in medications are very rarely subjected to clinical trial, so even the prescribing doctor is unsure of how your continued use of a particular medicine is going to impact your health.
• You place organs like your kidneys and liver at increased risk by taking large amounts of medication.
• Patients are often prescribed additional medication to counter the effects of existing medication. This additional medication, is, of course, also for life. Patients can end up with shelves of pills.
• Often expensive, these medications can, and do, drain the savings of many elderly patients.
• This pill mill places unnecessary demands on healthcare insurers who drive up premiums, an action that has a direct knock-on effect on the cost of care.

The topic is far too complex for a short article like this to explore in any depth, and I would highly recommend reading a series by Stephen Schimpff Md on Medika. The ten articles examine the issues in far more depth.

Stemming the tide

The problem of creating a medication dependent population can only be affectively addressed at its point of origin. The doctors consulting room. While doctors themselves are not to blame for the “management mentality” that pervades healthcare, they do act as the point of origin. They are also, much like they patients they treat, victims of the system.

Ridiculous time constraints and pressures brought to bear on doctors by insurers and the healthcare system they are obliged to operate within, all lead to one inevitable result. Quick in – quick out, with patients receiving only cursory care. Diagnosis suffers as a result. Patients are also conditioned to expect that leaving the consultation without a prescription in hand equates to poor treatment.

Both doctors and patients need to be re-educated on the primary goal of healthcare. It is to deliver care that prevents or cures disease and manages health. Drugs, in most instances, are temporary fixes to allow for healthy lifestyle choices to restore wellbeing. Our bodies are capable of reinvigorating themselves if the damage is identified early and the causes addressed.

Medicating someone up the yazoo and essentially turning them into prescription junkies does not improve quality of life. In point of fact, it often worsens it. As long as we continue to accept the current healthcare status quo, our health as a global population will continue to decline.

The post Forever Medicated is the Future of Healthcare appeared first on Medika Life.

Moreover, the external mission of many of these corporations, despite acknowledging the need to look beyond their walls, remains limited to slick mottos and TV spots. The traditional company excels in clinical validation and market access but often needs help with the critical third leg of innovation.

Innovation is a challenging and elusive concept that requires a delicate balance of internal and external collaboration. The innovator is often an unlikely figure, a lone disruptor or garage scientist. As the life sciences industry seeks to evolve and grow, it is crucial to plant the lightning rod in the right spot, reaching out to those unusual and eclectic sources that offer key insights and tangible innovations. It is not uncommon for the radical ideas in healthcare to percolate in today’s domestic micro-labs of patients and innovators who see things differently.

Today, the nature of innovation is both from the inside out and the outside in. The rigid walls of many corporations prevent collaboration, and the critical step is building the connective tissue that allows the voices of innovation to be heard and embraced. These lightning bolts can illuminate the world of life sciences and transform a small garage, waiting in obscurity, into tomorrow’s cathedral of innovation. The story of HP, Apple, Amazon, Disney, Google, and Microsoft is a testament to the power of these lightning bolts, which once sparked the growth of those giants from obscurity.

In this landscape, the importance of GPT and AI in the process of innovation cannot be overstated. These tools have the potential to break down internal walls and facilitate collaboration by providing a platform for the exchange of ideas and the processing of large amounts of data. The use of GPT and AI in the life sciences industry can foster the creation of new partnerships and the discovery of new insights that may lead to groundbreaking innovations.  Further, GPT can provide new and eclectic ideas (yes, lightning) just waiting for human curation.

The pursuit of innovation is an ever-evolving challenge for big pharma and the life sciences industry. However, by recognizing the power of external collaboration and placing the lightning rods in just the right places, the industry can drive forward to create new and transformative solutions to the world’s healthcare problems.

The post It’s Not Just The Lightning, But the Lightning Rod! appeared first on Medika Life.

The current clinical trial landscape

In 2020, 41% of Americans reported not knowing anything about clinical trials or their potential as a treatment option. That’s a huge percentage of the U.S. population that isn’t participating in research that could help them address serious health issues they’re facing. To correct this, we need an ecosystem-wide effort aimed at building awareness for patients, their advocates, and physicians.

Essential to this effort is a concerted, intentional approach to increase clinical trial access for communities historically underrepresented in clinical research. While there are currently 24,602 clinical trials recruiting participants in the U.S., 50% of FDA trials are conducted in only 1-2% of zip codes in the U.S., which means that millions of patients are shut out of research based solely on their geographic location or socioeconomic status. This primarily impacts people of color and those living in rural communities.

Benefits of clinical trials

It’s a status quo begging to be reimagined. Drugs can have a different effect on patients depending on their race and ethnicity, which emphasizes the importance of increasing diversity in trial participants to ensure safety and efficacy of therapeutics. And, even though every American who has taken over-the-counter or prescription medications has benefitted from a clinical trial, only 8.9% of us report being asked to participate in one.

Beyond the benefits to drug development, participation in clinical trials can provide participants with important advantages too. Patients can gain access to new treatments before they become widely available. They also receive regular, careful medical attention from physicians and other care professionals on the trial’s research team.

For some patients, participation can result in cures; one recently reported trial that evaluated a colorectal cancer treatment remarkably led to remission for every patient involved. Other recent trials have helped shrink tumors for patients with bile duct cancer and provided relief for those dealing with chronic depression. But clinical research provides no benefits if patients don’t know about them – and before we solve the participation challenge, we have to solve the awareness challenge.

Building networks has far-reaching effects

To raise awareness of clinical trials and encourage involvement, we must start by expanding the network of potential clinical trial sites and physicians who administer them. Too often, the community health centers that serve over 30 million Americans – including many members of the underrepresented groups that biopharma companies are seeking to reach and include – are simply left out of the equation.

A positive step forward would be to build up a new, expansive and inclusive network of trial sites and clinical trial investigators who can more effectively bring clinical research as a care option to their patients and communities. No one company can do this alone, but, as an industry working collectively, this is an achievable goal.

Additionally, digital technologies can be used to identify and provide information on clinical trials to people with particular diseases who may benefit most from trial participation, regardless of location. These technologies can also be leveraged to assist in communication throughout the trial process in order to enhance site design and patient experience, helping to boost engagement and prevent dropouts.  

Too many Americans don’t know enough about clinical trials to evaluate and choose participation, but we can take steps to solve that problem. We can work together across disciplines to identify and create sites in underrepresented communities, involve new physicians more directly to reach patients and encourage their involvement, and seek patient engagement and feedback throughout the trial process to enhance their experience and encourage future participation more effectively.

By empowering new communities to join in on clinical research, we can reach more patients to offer clinical research as a care option – and at the same time, enlist their help in creating more effective, safer medicines for those who will need them to live longer, healthier lives.

The post Clinical Trials As a Care Option – the Time is Now appeared first on Medika Life.

Championing Frontline Health Professionals Dedicated to Improving Access and Care, PPN Reaches over 100K+ listeners, Pharmacists, and Other Health System Influencers

NEW YORK, November 22, 2021 — Global independent marketing and communications firm FINN Partners today announced that starting December 1st, the Pharmacy Podcast Network (PPN) – a news
organization known for hosting and distribution of content that reaches 100,000+ in the pharmacy community – will join the agency. PPN and its new digital magazine Rx Influencer will operate as a unique unit of FINN, led by Todd Eury, vice president and executive producer. Eury, based in Pittsburgh, PA, will report to Gil Bashe, Global Health Chair, FINN Partners.

“Iconic newsstand media such as Forbes and BusinessWeek are evolving their business models – inviting once-readers to become paid ‘participant columnists’ – while The Atlantic and Wall Street Journal thrive
on edgy digital content and mainstage conferences. Today, ideas and opinions are honed and expressed across medium and channels – and FINN is following that lead, too,” said Peter Finn, Founding Partner,
FINN Partners.

“Pharmacists are central in every health setting – from neighborhoods to hospitals; long-term care residences to payer formulary committees; and in Federal and state policy forums. Payer, provider, and product innovation clients seek to reach this influential community, and PPN has evolved into the go-to content and digital platform for connection to this influential audience,” said Todd Eury, vice president, and Executive Producer, Pharmacy Podcast Network, a FINN division.

Growing Importance of the Pharmacy Community in Public Health

PPN has 100K+ monthly listeners to its programs and is ranked as one of the nation’s leading business audio programs alongside the Wall Street Journal, CNBC, and Bloomberg podcasts, making it the dominant leader in podcasting for the pharmacy industry. PPN also has some 20+ clients across the health ecosystem that sponsor their own podcast series, including the American Pharmacists Association, Omnicell, Surescripts, and Rx Safe. The PPN Twitter handle is followed by more than 25,000
people.

Producer Todd Eury will be part of the FINN community and continue to operate PPN independently and maintain authority over content decisions. FINN will have a direct connection to breaking trends, policies, and the needs of this front-line health professional community – growing in its importance to driving public health measures and operationalizing decentralized clinical trials for patient participation in drug development.

FINN at the forefront of an “omni-channel” communications approach.

“Beyond our leadership strength in earned and content media, thought leadership platforms, publishing, social media, and podcasting, FINN has been expanding its reach to enable client voice and priorities to be heard and reinforced,” said Gil Bashe, Global Health Chair, FINN Partners. “Our goal is to explore how
to be a stronger, direct bridge between clients and their customers. Pharmacists have that direct connection and demonstrated their life-saving importance once again in responding to COVID-19 vaccination urgencies,” he added.

A number of FINN clients – across Practices, geographies, and services – are focusing on the pharmacy sector for many reasons. These include leaders in consumer personal care, over-the-counter products, behind-the-counter devices to monitor and keep-in-check health concerns, and vaccines that prevent
serious, preventable illnesses. Pharmacy is the link from sick care to self-care.

About Pharmacy Podcast Network

Pharmacy Podcast Nation is the flagship show hosting all of the Pharmacy Podcast Network 1400+ episodes. With more than 30 different podcast programs and some 40 different co-hosts helping to develop audio content about the pharmacy sector, its reach includes communities, hospitals senior-care residences, military, and public health settings that meet the information needs of 300,000 pharmacists with more than 100,000 monthly listeners. PPN also delivers a unique publication called Rx Influencer to all healthcare professionals with a specific focus on pharmacy.

For more information visit: pharmacypodcast.com

About FINN Partners, Inc.

Founded in 2011 on the core principles of innovation and collaborative partnership, FINN Partners has more than quadrupled in size over the past 10 years, becoming one of the fastest-growing independent, integrated marketing agencies in the world. The full-service marketing and communications company’s record-setting pace is a result of organic growth and integrating new companies and new people into
the FINN world through a common philosophy. With more than 900 professionals, FINN provides clients with global access and capabilities in the Americas, Europe, and Asia. In addition, FINN provides its clients with access to top-tier agencies around the world through its membership in the global network PROI.

Headquartered in New York, FINN’s other offices are in Atlanta, Boston, Chicago, Denver, Detroit, Fort Lauderdale, Frankfurt, Hong Kong, Honolulu, Jerusalem, London, Los Angeles, Munich, Nashville, Paris, Portland, San Francisco, Seattle, Shanghai, Singapore, Southern California, and Washington D.C.

Find us at finnpartners.com and follow us on Twitter and Instagram at @finnpartners.

FINN CONTACTS:
Gil Bashe
gil.bashe@finnpartners.com
CELL: 732 371 0922

Celia Jones
celia.jones@finnpartners.co

The post FINN Partners Brings Aboard the Pharmacy Podcast Network appeared first on Medika Life.

That’s up 35% from $3.4 trillion on January 1, 2020, just as Covid-19 was beginning to take the world by storm.

In other words, U.S. billionaires have increased their wealth by a mouth-watering $1.2 trillion during the pandemic. As President Biden was at pains to point out during his recent address to Congress. twenty million Americans have lost their jobs over the same period.

Covid Vaccines have contributed massively to this shift in wealth. .A new report from Oxfam entitled “COVID vaccines create 9 new billionaires with combined wealth greater than cost of vaccinating world’s poorest countries” highlights the issue while underscoring mounting global pressure over vaccine disparity 

 Here are the names of new billionaires created in the last 18 months from the production of Covid vaccines.

1. Stéphane Bancel, CEO of Moderna, now worth $4.3 billion.
2. Ugur Sahin, CEO and co-founder of BioNTech, now worth $4 billion.
3. Timothy Springer, immunologist and founding investor of Moderna, now worth $2.2 billion.
4. Noubar Afeyan, Moderna’s chairman, now worth $1.9 billion.
5. Juan Lopez-Belmonte, chairman of Spanish drugmaker Rovi, which struck a deal to make ingredients for Moderna’s vaccine, now worth $1.8 billion.
6. Robert Langer, scientist and founding investor in Moderna, worth $1.6 billion.
7. Zhu Tao, co-founder and chief scientific officer at CanSino Biologics, worth $1.3 billion.
8. Qiu Dongxu, co-founder and senior vice president at CanSino Biologics, now worth $1.2 billion.
9. Mao Huihua, co-founder and senior vice president at CanSino Biologics, now worth $1 billion.

According to Anna Marriott, Oxfam’s Health Policy Manager;

“What a testament to our collective failure to control this cruel disease that we quickly create new vaccine billionaires but totally fail to vaccinate the billions who desperately need to feel safe. These billionaires are the human face of the huge profits many pharmaceutical corporations are making from the monopoly they hold on these vaccines. These vaccines were funded by public money and should be first and foremost a global public good, not a private profit opportunity. We need to urgently end these monopolies so that we can scale up vaccine production, drive down prices and vaccinate the world.”

A record 493 new faces joined Forbes’ World’s Billionaires list this year — roughly one new billionaire every 17 hours between March 2020 and March 2021 — including 98 newcomers from the U.S. That includes famous faces like Kim Kardashian West, moviemaker Tyler Perry and Apple CEO Tim Cook. It also includes ten new billionaires who got rich riding the SPAC wave, like laser lidar mogul Austin Russell and serial SPAC sponsors Chamath Palihapitiya and Bill Foley.

The pandemic hasn’t simply created or contributed to the creation of new billionaires, it has had a dramatic impact on the fortunes of established wealth. Elon Musk and Jeff Bezos lead the charge, seeing increases in their respective wealth of $144 billion and $86 billion since January of 2020.

I’ll do the math for you. That’s a total accumulation in wealth of $488 billion between ten people since January 2020, hardly an amount to be sneezed at. Share that out between the 20 million Americans who lost their jobs and they’d each be over $22,000 better off. 

The post The Covid Vaccine Billionaires. An Object Lesson in Profiting From a Pandemic appeared first on Medika Life.

Medika has recently launched an apothecary section, in which we intend to examine herbs and plants and the medicinal properties associated with these plants. We believe this natural reservoir offers a largely untapped source of treatment options for a host of medical conditions. The value of many of these natural compounds is only now beginning to enjoy serious attention.

I was shocked when a medical colleague questioned the inclusion of these articles in our publication, suggesting they are baseless and pseudoscience. The exact term used was “wooo”. Sadly, this opinion is shared by many colleagues and the alternative health sector is largely to blame for this perception. It has led to a widening chasm between modern medicine and traditional medicine, which is now seen as the home of modern-day witches, spiritualists, and charlatans.

Although this description of the vocal elements of alternate health is mostly accurate, it serves to detract from the real and tangible benefits these plants and herbs can offer and how oral health traditions often “know better”. We ignore this traditional knowledge at a cost to the patient and by diminishing traditional cures and remedies as “nonsense, we close our minds to a whole avenue of alternate care that is, allow me to remind you, based on centuries of evidence.

Time is the ultimate clinical challenge and remedies, however obscure, that have survived this test, deserve our full attention and further investigation. That is the driving focus behind our Apothecary series, highlighting potentially helpful plants and herbs that have fallen by wayside, simply because of poor brand management.

There are new treatments waiting to be discovered by science and far from being “wooo”, this is, in fact, an exciting and very real avenue of exploration for scientists and the pharma industry.

The Willow

One of the best examples of just how this knowledge can benefit medicine can be found in the bark of the humble willow tree. Willow bark has been used as a traditional medicine for more than 3500 years. Unknown to the ancient Sumerians and Egyptians who made use of it, the active agent within willow bark was salicin, which would later form the basis of the discovery of aspirin.

This one tree provided us one of the most widely used medicines in modern day health. According to Dr. Karol Watson, assistant professor of cardiology at the David Geffen School of Medicine at the University of California, Los Angeles,

Aspirin is one of those things that, long before there were ever clinical trials or any kind of scientific knowledge, people figured out, ‘Hey, I feel better when I take this substance’.

The drug has been making headlines recently because a study in The Lancet found that a daily aspirin appeared to lower the risk of cancer by at least 20% during a 20-year period. That’s based on data from more than 25,000 patients and builds on earlier findings that aspirin may lower the risk of colorectal cancer.

The research has limitations and is not definitive proof, but it does add another benefit to an ancient remedy that has been called a miracle drug. How ancient? Very. The ancient Egyptians used willow bark as a remedy for aches and pains and Hippocrates, the Greek physician who lived from about 460 to 377 B.C., wrote that willow leaves and bark relieved pain and fevers. Wooo that led us to identify salicylic acid and the modern-day wonder drug, Aspirin.

To be clear, none of these plants and herbs ascribe their healing properties to spiritual forces or faeries. They contain compounds, many of which are still not fully understood or adequately researched, that have been gifted to us by nature. Our desire to isolate ourselves from our biological ancestry, to somehow feel we are above nature and the processes that created us, is both mystifying and flawed.

Where our ancestors saw the work or hand of the spiritual guides and gods at play, we now see science. Science is however not a law unto itself and is subject to the forces and wonders of the natural world. It is these forces that led us to science and in which science is based. No matter how far we advance the field, this will remain a fundamental and inescapable truth. It would be deeply saddening to see the profession turn its back on its raison d’etre.

Towards Progress and the Future

We believe that there are still untold medical riches waiting to be discovered, hundreds of “willow trees” with their own magical, unexplored and undiscovered natural compounds, offering relief and possibly even cures to some of our most serious ailments.

Medika will continue to publish and highlight plants and herbs that we feel deserve a closer look, where discovering the mechanism of action and actual compounds these plants contain, could lead to new cutting edge treatments.

At the same time, we will continue to mercilessly pursue the scam artists, quacks, and charlatans that permeate both medicine and the alternate health sector. Individuals who ascribe miraculous, unfounded, and unproven properties and health claims to these plants and herbs. There is a route to realigning modern and traditional medicine and it lies in truth and transparency. Not wooo.

The post Setting the Record Straight. Plants and Herbs Have Value. appeared first on Medika Life.

The PPN is ranked in the top 25 podcasts in the same category as Bloomberg News, the Economist, and Wall Street Journal’s podcasts, Business News, and is the most accessed podcast platform in the world for the pharmacy professional — with nearly 80,000 listeners.

Meet Founder and CEO, Todd Eury

Pittsburgh native Todd Eury from Brownsville, Pennsylvania, started the first podcast centered on Pharmacy in 2009. Today, a decade later, the original blog site has grown into the global leader in podcasting about the pharmacy business and profession.

Known affectionately as The Pharmacy’s Biggest Fan, Todd is one of, if not the, most influential voice in pharmacy in the U.S and he has earned his wings in the industry the hard way. He boasts years of experience, including positions such as Associate Director of the Pennsylvania Pharmacists Association, founder of Pharmacy Future Leaders (a pharmacy student mentoring program), and Director of Business Development at New Season.

Todd currently serves as a member of The Board of Directors of American Pharmacy Purchasing Alliance. He is also the Founder and serves on the Advisory Board of Shift.Health, Shift.Health board is made up of the healthcare marketing industry’s most influential leaders & voices that are both established and emerging, representing both the present and future of the healthcare industry.

Despite his rise to fame, Todd Eury remains approachable and his genuine love for the pharmacy industry is palpable. He engages openly on social media and is supportive, clearly intent on “paying back” to his industry. If your business or vision relates to healthcare and pharma/pharmacy Todd is your man and Pharmacy Podcast Network is your channel of choice.

Getting in touch with Todd

Visit Pharmacy Podcast Network

The post Todd Eury, Pharmacy Podcast Network appeared first on Medika Life.

How does mRNA work and what is it?

mRNA medicines are sets of instructions and these instructions direct cells in the body to make proteins to prevent or fight disease. The m stands for messenger and RNA is ribonucleic acid, a part of our DNA. mRNA is a single-stranded molecule that carries genetic code from DNA in a cell’s nucleus to ribosomes, the cell’s protein-making machinery.

Without mRNA, your genetic code would never get used by your body. Proteins would never get made and your body wouldn’t (actually couldn’t) perform its functions. mRNA plays a vital role in human biology, specifically in a process known as protein synthesis. Rather than subjecting you to a long-winded explanation of exactly how mRNA functions, this video provides an excellent overview. 

What really matters is what these mechanisms have to do with medicine and how our mastery of nanoparticles has enabled science to manipulate processes at a level hitherto unachievable. The following is an overly simplified explanation to enable you to appreciate the potential of these new medicines. We don’t know how our cellphones work, but we appreciate the benefits they offer.

mRNA, DNA, and your body

Our DNA is ground zero for our bodies. Everything that happens inside us arguably originates in our DNA. It is the machine that powers our bodies and like all machines, is subject to breakages and manufacturing flaws. These can exhibit as diseases later in life, cancer, etc, or conditions that are genetic and affect a person at birth.

mRNA medicines provide us a mechanism to access the actual DNA machinery that regulates our health. Targetted solutions that can repair and address problems right at the source, at ground zero. 

mRNA medicines depend on really small nanoparticles to deliver the medicine’s payload or instructions. Solid lipid nanoparticles provide transport and measure anywhere from 1 to 1000 nanometres. To give you an idea of their scale, imagine this. 

In the International System of Units, the prefix “nano” means one-billionth; so one nanometer is one-billionth of a meter. It’s difficult to imagine just how small that is, so here are some examples: 

•  A sheet of paper is about 100,000 nanometers thick. 
• A strand of hair is 80,000 –100,000 nanometers in diameter. 
• There are 25,400,000 nanometers per inch. 
• Your fingernails grow about one nanometer per second!

It turns out these solid lipid nanoparticles (SLNP’s) are hugely important to the development of mRNA medicines and we’ve been tinkering with them since the early ’90s. The body easily accepts them without risk of rejection as companies now focus on the use of physiological lipids. They offer the perfect carrier.

The first drug using SLNP’s as a delivery mechanism, Onpattro was approved in 2018. You can read more about their delivery system for this drug here and as we all now know, in late 2020, several life-saving mRNA vaccines for SARS-CoV-2 were released. Moderna’s mRNA-1273 and Pfizer/BioNTech’s BNT162b2, also use lipid nanoparticles for their drug delivery system.

mRNA medicines have finally truly “arrived”. Their development over nearly three decades is a testament to open scientific collaboration, innovation, and sheer perseverance. The question now is what else can we use this novel technology for, and how can we use it to address disease?

Looking to tomorrow

Imagine the potential for being able to address diseases and genetic “glitches” at their root. Unborn children with identified genetic abnormalities could be born as healthy infants, thanks to early interventions made possible with these medicines.

Cancers and other diseases are currently being explored, to see how we can apply these drugs. High on the list are autoimmune disorders, a natural starting point after the success of the vaccine, and the technology’s established ability to impact the immune system. Recently, a team led by Ugur Sahin has designed an mRNA vaccine that can restore tolerance to myelin proteins in mice, reducing the severity of multiple sclerosis-like symptoms, while maintaining the immune response towards other antigens.

On the subject of mRNA Cancer Vaccines, a recent article in PubMed suggests another novel application for mRNA. Apart from being used directly to vaccinate patients, mRNAs can also be used in cellular therapies to transfect patient-derived cells in vitro and infuse the manipulated cells back into the patient. The technology is so rapid and cost-effective that it can be tailored to individual patients and their particular genetic code.

mRNA may be on course to do for modern medicine what Flemming’s penicillin did for healthcare in the early twentieth century. It holds out huge promise that may, for now, only be limited by existing technology and our ability to innovate. Watch this space.

The post Is mRNA Technology the New Penicillin? appeared first on Medika Life.

Why we react to vaccines

Almost every medication that is dispensed has side effects that affect a very small percentage of people. This include OTC medications, but typically, the severity of reported and known side-effects tend to increase with the scheduling guidelines of a drug. The stricter the controls, the more severe the potential side effects become. 

Its not a hard a fast rule and even the common aspirin can potentially kill you, if you develop an allergic reaction. Vaccines are no exception, apart from one fundamental difference. We all get vaccinated. Many of us will never be exposed to cancer drugs, anti-depressants or experimental retro-virals to combat HIV and other diseases. 

We won’t need these medications as most will not develop the related diseases or conditions. Vaccines however are different. They are administered to everyone to prevent rather than treat disease and therein lies the moral dilemma faced by an industry whose raison d’être is “First do no harm”. Because of this increased exposure to a wider demographic, vaccines are more rigorously tested than any other drug and can take years to reach the marketplace.

Notwithstanding, the resultant side effects for those of us who are unfortunate enough to react to a vaccine can be debilitating. Anti-vaxers would have you believe this is reason enough to avoid having yourself or your children vaccinated. 

Nothing could be further from the truth, and it is because of vaccines that we have successfully eradicated diseases like polio and smallpox. To fully and adequately protect our children against a myriad of childhood diseases, we accept this minuscule risk and vaccinate. 

Sometimes, unavoidably and unfortunately, vaccination goes wrong. It isn’t however just children that bear the brunt. Teenagers and adults of all ages run a risk and can and do fall ill, or develop diseases from the administration of a vaccine. Exact figures are hard to come by as some instances are incorrectly diagnosed or direct causality is too tentative to ascribe with any degree of certainty.

Seeking redress for injury or death

Individuals within the borders and territories of the U.S. are able to seek compensation in one of two ways. 

• A lawsuit, which can be filed directly against the pharmaceutical manufacturer of a vaccine. This is a costly process that will require the ‘victim’ to meet legal costs, costs which may or may not be recovered as part of an agreed settlement or order of the courts. In certain instances, where others have experienced similar side effects, an existing ruling may offer relief, or a victim may join a class action brought on behalf of a group of patients who have suffered similar side effects.
• In the U.S. however, a unique fund exists, created in 1986 and referred to by its acronym, the NVICP, that offers alternative relief.

Who is the NVICP?

The National Vaccine Injury Compensation Program (NVICP) is a no-fault alternative to the traditional legal system that allows for vaccine-injured petitioners to seek compensation when certain circumstances have been met. 

The initial goals of the Vaccine Program were to:

1. Ensure adequate supply of vaccines; and
2. Compensate individuals injured by vaccines.

The Vaccine Injury Compensation Trust Fund provides funding for the program, sourced from a $.75 excise tax imposed on each dose of those vaccines listed within the Vaccine Injury Table.

As part of the National Childhood Vaccine Injury Act of 1986, the NVICP was created in response to civil lawsuits filed against healthcare providers and vaccine manufacturers, which resulted in manufacturers incurring significant financial liability. With the implementation of the NVICP, both vaccine manufacturers and private individuals are considered. The Program promotes public health interests while remaining prepared for negative outcomes in individual cases.

Which vaccines do the NVICP cover?

The Health Resources and Services Administration keeps an up to date list of vaccines covered under the National Vaccine Injury Compensation Program. The most recent list (revised March 21, 2017) can be found here.

• Diphtheria, pertussis, tetanus (DTP, DTaP, Tdap, DT, Td, or TT)
• Haemophilus influenzae type b (Hib)
• Hepatitis A (HAV)
• Hepatitis B (HBV)
• Seasonal Influenza (Flu) Vaccine
• Measles-mumps-rubella (MMR, MR, M, R)
• Meningococcal (conjugate & polysaccharide) (MCV4, MPSV4)
• Polio (IPV, OPV)
• Pneumococcal conjugate (PCV)
• Rotovirus (RV)
• Varicella (VZV)
• Human Papillomavirus (HPV)
• Any combination of above vaccines

Who can file in the NVICP?

Anyone can file a petition in the National Vaccine Injury Compensation Program, regardless of age or citizenship status, as long as the effects of the injury (1) lasted for more than 6 months after the vaccination, (2) resulted in inpatient hospitalization and surgical intervention while hospitalized, or (3) resulted in death.

You may file a petition if:

• You received a covered vaccine and believe you have been injured as a result of this vaccination;
• You are the parent or legal guardian of a child or disabled adult whom you believe has been injured by a covered vaccine;
• You are the legal representative of the estate of a deceased person who you believe was injured by a covered vaccine and/or whose death you believe was a result of the covered vaccine.

The covered vaccine must have been administered in the United States or its territories unless:

1. The person who received the vaccine was, at the time of treatment, serving abroad as a member of the Armed Forces or as an U.S. Government employee, or is the dependent of such a citizen; or
2. The vaccine was manufactured in the United States and the person filing the petition returned to the United States within 6 months of the date of vaccination.

How do I file?

In cases of injury, petitions must be filed within 3 years of the first symptom or manifestation of the injury. In cases involving death, petitions must be filed within 2 years of death and within 4 years of the first symptom in cases where death resulted from the injury. 

In cases where a vaccine was added to the table of covered vaccinations, petitions must be filed within 2 years of the date of the table change, and injuries or death must have occurred within the 8 years prior to the table change. In order to petition for compensation through the NVICP, you must file a petition with the U.S. Court of Federal Claims.

 Because this is a legal process, many petitioners retain an attorney to assist them in this process.

How much will it cost?

Unlike traditional legal cases, petitioners who file claims in the NVICP do not pay any legal fees. Attorneys’ fees and costs can be paid by the NVICP, not the injured petitioners. Just as the Vaccine Injury Compensation Trust Fund is used to compensate those who suffer from vaccine-related injuries or death, these funds may be used to compensate legal counsel representing petitioners.

The process of selecting an attorney is also fraught with pitfalls and when in doubt, always look to larger established firms for safe and ethical representation. The firm Conway Homer, P.C. is the most experienced vaccine injury law firm in the United States. They represent clients from all 50 states and have advocated for landmark cases that have shaped the Vaccine Program. 

The post What Are Your Options When Vaccine Injury Changes Your Life appeared first on Medika Life.