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    Pharma: Not Their First Rodeo – Umberto Meduri & Paul Marik on DarkHorse

    en-usAugust 05, 2023

    Podcast Summary

    • Pharmaceutical companies' delay tactics obstruct scientific discoveriesPharmaceutical companies' efforts to hinder investigations into their practices can lead to significant discoveries that challenge ethical and professional standards, as experienced by professors Humberto Maduri and Paul Merrick.

      The delay tactics used by certain pharmaceutical companies to prevent the closure of investigations into their practices can lead to significant discoveries that challenge ethical, moral, and professional standards. This was the case for Humberto Maduri, a professor of pharmaceutical science, who faced obstruction from a pharmaceutical company regarding his discovery of useful therapeutics. This pattern of scientific interference is not unique to the COVID-19 pandemic, but rather a recurring issue in various scientific fields. Paul Merrick, a former professor with credentials in internal medicine, critical care medicine, neurocritical care, nutrition science, pharmacology, anesthesia, and tropical medicine, also experienced this issue. The discussion on the Dark Horse podcast highlights the importance of understanding this pattern and its implications for public health. Additionally, the episode is sponsored by House of Macadamias, a company dedicated to making macadamia nuts accessible to everyone, offering a variety of delicious and health-conscious products.

    • WHO's corticosteroid recommendation for COVID-19 may be inaccurateStudies show corticosteroids can reduce mortality by up to 50% in severe viral infections like COVID-19, SARS, and MERS when used correctly and for a specific duration

      The World Health Organization's (WHO) recommendation against using corticosteroids for severe respiratory distress in COVID-19 patients may not be accurate. While they cited potential complications and ineffectiveness, studies show that when used correctly and for a specific duration, corticosteroids can reduce mortality by up to 50% in SARS, MERS, and potentially COVID-19. These drugs, which have been in use for decades, are known to treat symptoms that kill COVID-19 patients, such as inflammation. Inflammation is the body's first line of defense against infections but can become harmful if it persists. The issue is not the inflammation itself but the prolonged and uncontrolled response. The misconception lies in the belief that inflammation is always bad, but it is crucial for the body's healing process. The key is to resolve the inflammation and restore damaged tissue once the infection is eliminated. The evidence suggests that corticosteroids, as part of a specific protocol, could be effective in treating severe viral infections like COVID-19, SARS, and MERS.

    • The role of inflammation in causing harm during infectionsStudies show high inflammation levels increase risk of complications, steroids can help decrease inflammation and reduce bacterial growth, and uncontrolled inflammation may be caused by insufficient receptors for glucocorticoids.

      An overactive inflammatory response, rather than the infection itself, can cause harm and even death in some patients. The glucocorticoids produced by the adrenal gland normally help regulate this response by binding to receptors in cells and influencing protein production. However, an inadequacy of these receptors can lead to an uncontrolled inflammatory response. This hypothesis is that pathogens may intentionally keep their hosts somewhat sick to ensure they are contagious but not too sick to move around. When the body becomes critically ill, the pathogen may produce more virus to spread, potentially capturing the inflammatory response and leading to hyperinflammation. Studies have shown that patients with high levels of inflammation are more likely to develop complications like pneumonia, which is not directly caused by the infection but by the dysregulated inflammation. Exposure to high levels of cytokines, markers of inflammation, can actually promote bacterial growth. Steroids, like methylprednisolone, can help bring down these cytokine levels and reverse excessive bacterial growth. This research suggests that steroids not only decrease the duration of mechanical ventilation but also create an environment less favorable to bacterial growth. This knowledge could potentially lead to new treatments for patients with uncontrolled inflammation.

    • Early administration of antibiotics and corticosteroids crucial for severe infectionsDuring severe bacterial infections, early use of antibiotics and corticosteroids can control the overactive inflammatory response, saving lives. Genetics and age can influence the severity of the response, requiring external steroid help and micronutrient support.

      During severe infections with overwhelming inflammation, early administration of both antibiotics and corticosteroids is crucial for patients' recovery. This is because bacterial infections can exploit the body's natural inflammatory response, leading to a dangerous and potentially life-threatening situation. The need for these treatments is not about finding the latest targeted drug but rather using well-known medications to control the overactive inflammatory pathway. Additionally, there seems to be a genetic component that predisposes some individuals to an exaggerated inflammatory response. Elderly patients are more susceptible to this condition due to their advanced age, while younger individuals have more protection from an evolutionary standpoint. Furthermore, not all patients respond to endogenous steroids, so external help may be necessary. It is essential to provide not only the steroids but also essential micronutrients like vitamin D, vitamin C, and thiamine to maximize their effect and support overall health. Despite this, it is surprising that reasonable measures to help patients before and after they get sick, such as vitamin D supplementation and corticosteroid administration, are not widely recommended.

    • Overlooked Benefits of Steroids for COVID-19 ARDS PatientsThe WHO missed crucial information about steroids' benefits for COVID-19 ARDS patients due to lack of financial incentives, causing a significant delay in effective treatment.

      During the early stages of the COVID-19 pandemic, crucial information regarding the use of glucocorticoids for Acute Respiratory Distress Syndrome (ARDS) was overlooked by the World Health Organization (WHO). This oversight led to a delay in recommending steroids as a potential life-saving treatment for critically ill COVID-19 patients. The data, including a study published in the Lancet just weeks before COVID-19 emerged, clearly showed the benefits of steroids in improving ARDS, decreasing the duration of mechanical ventilation, and reducing mortality. However, the WHO missed this critical information, likely due to the lack of financial incentives for drug companies to invest in and promote the use of generic steroids. This missed opportunity resulted in a significant delay in providing effective treatment to patients, highlighting the importance of thorough and unbiased evaluation of existing evidence in guiding clinical practice.

    • Misrepresentation and underutilization of COVID-19 treatmentsEffective drugs like hydroxychloroquine, ivermectin, and corticosteroids have been misrepresented or underutilized due to biased studies or profit motives, potentially leading to needless deaths.

      The history of COVID-19 treatments has seen instances where effective drugs were misrepresented or underutilized due to biased studies or profit motives. For example, hydroxychloroquine was misdosed in some studies, making it appear ineffective or dangerous. Ivermectin was underdosed in others, making it seem ineffective against COVID-19. In the case of corticosteroids, studies failed to taper doses at the end of treatment, leading to negative outcomes and the recommendation against their use. These patterns are concerning as they suggest a systematic effort to discredit drugs with little profit potential in favor of more profitable alternatives, even if they are less effective or even dangerous. This trend was exemplified by a study on steroids before COVID-19, which removed the drug from treatment and led to increased ventilator use and deaths. If doctors had been left to make their own decisions during the pandemic, they may have recognized the importance of steroids and reduced the number of patients requiring ventilators, potentially saving lives. However, the centralization of medical guidance during the pandemic led to a reluctance among doctors to deviate from the narrative, resulting in needless deaths among COVID-19 patients.

    • Doctors' Dilemma: Patient Care vs Professional ConsequencesDoctors must prioritize their patients' needs over professional repercussions, even in a pandemic, using their clinical judgment to provide the best care possible.

      The pandemic environment created a dilemma for doctors, pitting their professional duty to their patients against the fear of professional repercussions for going against official guidelines. Doctors, who are supposed to put their patients' lives first, were faced with the risk of losing their ability to practice medicine if they deviated from the officially sanctioned treatment plans. This fear led many doctors to override their medical instincts and not provide treatments they believed would help their patients. The situation was further complicated by the fact that medicine is both a science and an art, and every patient and situation is unique. Ultimately, the physician's responsibility is to their patient, and they must decide what is best for their patient, not what is more convenient or what will minimize the risk of professional consequences. The pandemic highlighted the importance of doctors being able to use their clinical judgment and not being silenced by external organizations. The consequences of not following the science and not allowing doctors to use their clinical judgment led to unnecessary suffering and deaths.

    • The role of public health in medicine: Balancing the greater good with patient autonomyPublic health should support doctors in making informed decisions for their patients, rather than dictating medical practices.

      The relationship between public health and medicine has been a subject of debate, with some arguing that public health has the power to override a doctor's judgment for the greater good of the population. However, this perspective is increasingly being challenged as an infringement on the doctor-patient relationship and a potential threat to patient safety. The discussion also touched upon the concern that various healthcare agencies and institutions have been captured by big pharma, leading to a skewed focus on profit over patient care. This was exemplified by the historical case of steroid treatment for ARDS, where the misuse of data and lack of transparency led to the abandonment of a potentially life-saving treatment. Ultimately, it was emphasized that public health should serve as a resource for doctors to make informed decisions for their patients, rather than a force that dictates medical practices.

    • Discovering the Benefits of Steroids in Early ARDSSteroids can improve lung function and survival in early ARDS, but careful tapering is necessary to avoid complications.

      During the early stages of Acute Respiratory Distress Syndrome (ARDS), administering steroids can significantly improve patient outcomes, including lung function and survival. This was first discovered through a small, ethical study that reported a decrease in mortality from 70-80% to about 20%, and the first identification of the cytokine storm. The study was conducted in an environment conducive to clinical investigation, and researchers obtained serial lung samples and blood tests to understand the disease progression. The findings showed that inflammation levels at the beginning of the disease determined the outcome, and steroids helped transition the patient from an abnormal state to a normal one. However, ethical considerations were taken into account, including the potential for infection and the implementation of surveillance to identify infections in the absence of fever. The study was criticized but later reproduced by the ARDS Network, which led to the discovery that tapering steroids is essential to avoid complications. The researchers then started a new study to investigate the impact of steroids in early ARDS, with promising results.

    • Sepsis causes inflammation and organ damage, leading to ARDS and hypoxemiaSepsis triggers inflammation, leading to ARDS, hypoxemia, and potential organ damage. Steroids can help reduce ventilation duration and mortality.

      Sepsis is a severe infection that triggers a systemic response, leading to inflammation and potential organ damage. This inflammation can cause leakage of plasma into the lungs, resulting in flooding and the inability for oxygen exchange to occur. This condition, known as ARDS, can lead to severe hypoxemia and the need for a ventilator. Cytokines, which are both markers and inducers of inflammation, play a significant role in this process. In the case of severe sepsis or ARDS, the release of these cytokines can lead to a destructive inflammatory cascade, potentially causing further damage to the lungs and other organs. The use of steroids has been shown to reduce the duration of mechanical ventilation and mortality in such cases. However, it's important to note that early recognition and intervention are crucial in managing these conditions effectively.

    • Peer-review process manipulationThe peer-review process can be influenced by powerful interests, leading to delayed publication of unbiased research and potential harm to patients.

      The peer-review process in scientific publishing is not as unbiased as it may seem. In the case discussed, the New England Journal of Medicine held onto a study showing the effectiveness of a cheap, lifesaving treatment for severe sepsis for 11 months before publishing it, while publishing a competing study from a larger pharmaceutical company sooner. This delay prevented doctors from comparing the two studies and potentially led to inferior care and unnecessary deaths. The peer-review process can be manipulated by powerful interests, and it's crucial for the public to advocate for unbiased research and transparency in the publishing industry. The corruption in this case is not just isolated, but a pervasive issue where pharmaceutical companies have undue influence over what drugs get prescribed. We need to prioritize research conducted by those with no stake in the outcome and ensure that the findings are made accessible to the public for informed decision-making.

    • Pharmaceutical industry bias in scientific studiesPharmaceutical companies' funding and influence can lead to biased studies, potentially overlooking safer and more effective alternatives

      The pharmaceutical industry's involvement in funding, contracting, and incentivizing scientific studies can lead to a biased system where their drugs are prioritized, potentially at the expense of safer and more effective alternatives. This issue isn't limited to COVID-19 but has been ongoing for decades. A notable example is the case of Umberto, who conducted a study on corticosteroids in AODS but was accused of scientific misconduct and had his study shut down due to pressure from pharmaceutical companies or regulatory agencies. This incident led to the publication of an investigative article, "White Sheep Drugs," which highlighted the underutilization of cheap drugs and the financial incentives that drive the pharmaceutical industry. However, after the publication of the article, Umberto's research program was shut down under allegations of scientific misconduct, which he later discovered were unfounded. The incident underscores the need for transparency and ethical conduct in scientific research, particularly when it comes to pharmaceutical companies' influence.

    • A researcher falsely accused of misconduct faces consequencesUniversities must be transparent and fair when handling allegations of scientific misconduct to prevent damage to innocent researchers' reputations and advancement of knowledge.

      The academic community and institutions must be held accountable for their handling of allegations of scientific misconduct. In this case, a researcher, Umberto, was falsely accused of misconduct regarding his life-saving research on steroids for COVID-19. Despite the Wall Street Journal covering his work prominently and the investigation finding no evidence of misconduct, Umberto's research was threatened, and he was demanded to sign a waiver of liability to prevent him from holding the university responsible for damage to his reputation. When he refused, the university removed all evidence supporting him and fabricated misconduct allegations. The chancellor, who was a decent guy, was not informed of the situation, and Umberto was shocked when he was accused in front of his colleagues and demanded to retract his prior publications and stop ongoing studies. The situation could have prevented the advancement of knowledge about steroids for COVID-19, but Umberto took legal action and eventually prevailed. However, the Office of Research Integrity, which is responsible for supervising such matters, was criticized for its lack of professionalism and disregard for falsely accused individuals. The statistician, who knew the results of Umberto's study and falsely reported him for misconduct, added to the astonishing nature of the situation.

    • Pharmaceutical Industry's Control TacticsThe pharmaceutical industry's influence over research and regulation undermines trust in medical research and the doctor-patient relationship, necessitating support for independent voices questioning drug safety and efficacy.

      The pharmaceutical industry wields significant power and influence, using tactics reminiscent of mafia intimidation, to control the narrative around drugs and research. Researchers who challenge this narrative risk facing professional consequences, including charges of misconduct and reputational damage. The regulatory agencies, intended to keep big pharma in check, often collude with them instead, perpetuating this cycle of control. The public is left in the dark, unaware that the very people they should trust are being silenced. This situation undermines the integrity of medical research and the doctor-patient relationship. It's crucial to support and listen to those who challenge the status quo and question the safety and efficacy of new drugs, rather than accepting the narratives pushed by the pharmaceutical industry.

    • Long-standing overlooked treatment for inflammatory symptomsSteroids, a safe and effective treatment for inflammatory symptoms, have been overshadowed by pharmaceutical companies' pursuit of new, expensive drugs.

      The use of steroids for treating inflammatory symptoms that have gotten out of control is not a new discovery, but rather a long-standing treatment that has been overlooked due to pharmaceutical companies' pursuit of new drugs for profit. The speaker's research on the effectiveness of steroids for Respiratory Distress Syndrome (RDS) was met with accusations of misconduct, which spread globally and called into question the validity of the data. The drug that was threatened by these discoveries, Eli Lilly's expensive treatment for RDS, was later found to be no more effective than a placebo, yet it had cost thousands of dollars per dose and had serious side effects. The callousness of derailing safe, effective treatments in favor of expensive and potentially dangerous alternatives is a concerning issue in the pharmaceutical industry. Despite the clear evidence of steroids' effectiveness for RDS, misinformation continues to persist, with some organizations and websites failing to mention steroids as a treatment option.

    • Disconnect between ARDS research and information disseminationDespite steroids being effective, inexpensive, and reducing ventilation duration, lack of info on major research sites may cost thousands of lives annually and prioritize profits over patient care

      There exists a significant disconnect between research and information dissemination, particularly in the case of Acute Respiratory Distress Syndrome (ARDS) and the use of corticosteroids. Despite steroids being a proven, inexpensive, and effective treatment for ARDS, there is a lack of information about it on major research institutions' websites. This lack of information may be due to the control of information by federally supported institutions and could potentially be costing thousands of lives annually, both in the US and globally. The longer a patient is on a ventilator, the more likely they are to have complications and die within a year. Steroids can reduce the duration of mechanical ventilation by up to 10 days, leading to significant cost savings and improved long-term outcomes. The callousness of the pharmaceutical system, as highlighted in the discussion, raises concerns about the prioritization of profits over patient care and the potential for needless deaths.

    • Deliberate suppression of effective COVID-19 treatmentsPowerful entities withheld effective treatments like steroids, ivermectin, and hydroxychloroquine, causing unnecessary deaths, economic damage, and hospital overload.

      The withholding of effective treatments for COVID-19, such as steroids, ivermectin, and hydroxychloroquine, contributed significantly to unnecessary deaths, economic destruction, and hospital overload. This was due to a deliberate suppression of information about these treatments by those with power over the public health establishment, medical schools, universities, and social media platforms. The pharmaceutical industry, which profits from unhealthy people, may have played a role in this interference with good science and patient health. The use of steroids, which have been shown to reduce the burden of hospitalization and save lives, is a prime example of a treatment that was not widely used during the pandemic. There is a need for continued research and improvement in the understanding and application of these treatments for various diseases, as they all involve the glucocorticoid receptor.

    • The discovery of corticosteroids for ARDS treatment could have saved hundreds of thousands of lives annuallyThe lack of profitability and suppression of research on older, off-patent drugs prevented the widespread adoption of corticosteroids for ARDS treatment, leading to the needless deaths of 350,000 people a year and a research gap that hindered preparedness for the COVID-19 pandemic

      The discovery of the effectiveness of corticosteroids in treating Acute Respiratory Distress Syndrome (ARDS) in the early 2000s was a significant one, as it could have potentially saved hundreds of thousands of lives annually. However, due to various reasons, including the lack of profitability and the suppression of research on older, off-patent drugs, this treatment was not widely adopted. As a result, approximately 350,000 people a year needlessly died from ARDS, and many more suffered from long-term consequences. Additionally, the research gap during this period prevented the world from being better prepared for the COVID-19 pandemic, as the knowledge that could have been gained from studying corticosteroids and other repurposed drugs was not available. This situation highlights the importance of prioritizing patient care and preventive measures, as well as the need for a more balanced approach to medical research that prioritizes both profit and patient wellbeing.

    • Conflicts of interest in COVID-19 researchConcerns about industry influence on research and regulatory decisions for COVID-19 treatments, with potential suppression of alternative options and prioritization of profit-driven technology

      There are concerns about conflicts of interest and potential suppression of alternative treatments in the research and approval process for COVID-19 related studies. The discussion highlights an instance where a steroid study was blocked, and the person in charge of deciding which studies get approved was also the head of a study on an Eli Lilly drug that was no better than a placebo and dangerous. This situation raises questions about the potential influence of industry players on research and regulatory decisions. Additionally, the conversation touches upon the hypothesis that the lack of acknowledgement and use of existing treatments for COVID-19, such as Ivermectin, created a profit center for mRNA technology through emergency use authorizations, even though the technology is not yet safe enough for widespread use.

    • Controversy over COVID-19 treatments and their impact on mortalityDuring the pandemic, some hospitals used steroid-based treatments with successful outcomes and lower mortality rates, while others did not. Neglecting alternative treatments can have serious consequences.

      During the COVID-19 pandemic, there was a controversy surrounding the use of certain treatments for hospitalized patients, with some institutions following protocols that included steroids and others not. The speaker, who used a steroid-based treatment, reported excellent outcomes and a significant reduction in mortality, while the world average for hospital mortality was much higher. The speaker criticized the callousness of government officials who neglected treatments while pretending to be concerned about public health. Despite the challenges and the presence of self-serving individuals, the speaker emphasized the importance of good people who supported them throughout the crisis. The speaker's experience highlights the importance of considering alternative treatments and the potential consequences of neglecting them.

    • The healthcare system and pharmaceutical industry prioritize profit over healthThe healthcare system and pharmaceutical industry need a radical overhaul to prioritize patient care and well-being over profit, as the current system prioritizes profit and harms patients through unnecessary treatments and interference.

      The current healthcare system and pharmaceutical industry have become dysfunctional and prioritize profit over promoting health and well-being. The pharmaceutical industry's interference in the healthcare system, including creating demand for their products, is a major concern and can be compared to a criminal racket. The COVID crisis and the accumulated costs over the past two decades serve as clear evidence of this issue. It's crucial to recognize this and work towards taking back control of the healthcare system to prioritize patient health and well-being. The consequences of ignoring this issue could be dire, including unnecessary harm and even death. The speakers emphasized the importance of acknowledging this issue and taking action to put an end to it. Overall, the healthcare system and pharmaceutical industry need a radical overhaul to prioritize patient care and well-being over profit.

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    Anecdote in Science: The 224th Evolutionary Lens with Bret Weinstein and Heather Heying

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    Mentioned in this episode:

    Laumer et al 2024. Active self-treatment of a facial wound with a biologically active plant by a male Sumatran orangutan. Scientific Reports, 14(1), p.8932. https://www.nature.com/articles/s41598-024-58988-7

    County Highway: https://www.countyhighway.com

    Thousands Believe Covid Vaccines Harmed Them. Is Anyone Listening? https://www.nytimes.com/2024/05/03/health/covid-vaccines-side-effects.html

    Chris Martenson on the NYT: https://twitter.com/chrismartenson/status/1787602191114526836

    Benn et al 2023. Randomized clinical trials of COVID-19 vaccines: Do adenovirus-vector vaccines have beneficial non-specific effects?. Iscience, 26(5): https://portal.findresearcher.sdu.dk/en/publications/randomized-clinical-trials-of-covid-19-vaccines-do-adenovirus-vec

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    Mentioned in this episode:

    Third Man Syndrome and Shackleton: https://twitter.com/brianroemmele/status/1785827941718614291

    Clearer skies may be accelerating global warming: https://www.science.org/content/article/clearer-skies-may-be-accelerating-global-warming
     
    Hodnebrog et al 2024. Recent reductions in aerosol emissions have increased Earth’s energy imbalance. Communications Earth & Environment, 5(1):166: https://www.nature.com/articles/s43247-024-01324-8

    Nature editorial: What happens when climate change and the mental-health crisis collide? https://www.nature.com/articles/d41586-024-00993-x

    Animation about mental health and climate change: https://www.imperial.ac.uk/grantham/publications/all-publications/the-impact-of-climate-change-on-mental-health-and-emotional-wellbeing-current-evidence-and-implications-for-policy-and-practice.php

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    We're Beating the WHO – With Dr. Kat Lindley

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    Why Darwin was Right: The 222nd Evolutionary Lens with Bret Weinstein and Heather Heying

    Why Darwin was Right: The 222nd Evolutionary Lens with Bret Weinstein and Heather Heying

    In this 222nd in a series of live discussions with Bret Weinstein and Heather Heying (both PhDs in Biology), we talk about the state of the world through an evolutionary lens.

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    Mentioned in this episode:

    Kennedy 2023. The Wuhan Cover-Up and the Terrifying Bio-Weapons Arms Race: https://www.skyhorsepublishing.com/9781510773981/the-wuhan-cover-up/

    Kuo et al 2000. Retargeting of coronavirus by substitution of the spike glycoprotein ectodomain: crossing the host cell species barrier. Journal of virology, 74(3):1393-1406: https://journals.asm.org/doi/full/10.1128/jvi.74.3.1393-1406.2000

    Rodríguez-Montes et al 2023. Sex-biased gene expression across mammalian organ development and evolution. Science 382(6670), p.eadf1046: https://www.science.org/doi/10.1126/science.adf1046

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    Related Episodes

    Treating Respiratory Diseases & Inflammation w/ Stan Miele of Aqualung Therapeutics - BRT S04 EP14 (176) 4-2-2023

    Treating Respiratory Diseases & Inflammation w/ Stan Miele of Aqualung Therapeutics  - BRT S04 EP14 (176) 4-2-2023

    Treating Respiratory Diseases & Inflammation w/ Stan Miele of Aqualung Therapeutics

     

    - BRT S04 EP14 (176) 4-2-2023

     

    Things We Learned This Week

    • Aqualung Therapeutics is treating inflammation in the lungs, getting people off ventilators (cut down 50%) & saving lives
    • ARDS - Acute Respiratory Disease Syndrome - serious lung condition that causes low blood oxygen & fluid in the lungs
    • Aqualung's novel therapeutics are also reversing fibrosis / scar tissue in lungs - could be used in future to treat other diseases

     

     

     

     

    Guest: Stan Miele
    President & CBO

    Aqualung Therapeutics Corp

     

    LKIN: HERE

    www.aqualungtherapeutics.com

     

    Stan Miele Bio:

    A recognized global executive with success in sales, marketing and P&L leadership in the pharmaceutical/medical device and biotech industries. Mr. Miele was formally the Chief Commercial Officer at bioLytical Laboratories and Sucampo Pharmaceuticals Inc.  He was also President of Sucampo Pharma Americas for 6 years.   He was instrumental on some key licensing agreements for Sucampo, inclusive of the agreement with Abbott Japan, and also Takeda Pharmaceuticals (now Shire).  He is actively part of the team ensuring proper execution of clinical development, manufacturing, licensing, capital funding, alliances, and ensuring Aqualung meets all critical milestones.  He will be helping the company move toward accelerating the pipeline/platform technology and moving eNamptor™ toward commercialization.

     

    Joe G.N. “Skip” Garcia, MD

    FOUNDER & CHIEF EXECUTIVE OFFICER

    Joe G. N. "Skip" Garcia, MD, is an internationally-noted pulmonary physician-scientist, an endowed professor of medicine at the University of Arizona College of Medicine – Tucson, and an elected member of the National Academy of Medicine. A noted academic health system administrator, scholar and educator, Dr. Garcia is a leading authority on the genetic basis of lung disease and the prevention and treatment of inflammatory lung injury. Dr. Garcia is internationally recognized for development of novel biomarkers and therapies for critically ill patients with acute inflammatory lung disease and for addressing health disparities in vulnerable populations. He has over 575 peer-reviewed publications, an expansive portfolio of NIH-sponsored research, and continues to direct large federally-funded programs.  

     

    Aqualung Therapeutics

    Aqualung Therapeutics (ALT) is developing multi-pronged strategies to address the development of severe lung inflammation which is essential to the severity and outcomes of acute and chronic lung disorders such as acute lung injury, ventilator-induced lung injury (VILI), idiopathic pulmonary fibrosis, and pulmonary hypertension. Effective FDA-approved drugs are either currently unavailable or extraordinarily modest in their ability to modify disease progression. No drug is currently available that is preventive or curative. Aqualung’s strategies, which include deployment of a human monoclonal antibody which targets a novel inflammatory mediator (nicotinamide phosphoribosyltransferase or NAMPT) will address the unmet need for novel, effective therapies for VILI, IPF, and pulmonary hypertension.

     

    Notes:

    Seg 1  

    Cornerstone of health tech comes from biotech & spin offs from incubator universities – an idea with proof of concept becomes a company

    NIH investment – National Institute of Health has different divisions & a governing body, they review grant submissions from University level inception of biotech 

    The idea is then sold to large pharmaceutical co. – the process is very expensive, takes decades of R & D to bring a product to market

    Grants – R41 or R42 as examples of investment from NIH

    NIH works w/ startups, biotech & universities – helps w/ early funding of $ thousands to millions 

    Supports basic science & research, to fund an initial scientific thesis, this is pre-clinical and non-dilutive capital from NIH or Government

    This is important, because venture capital can be brought to raise more funding, and not be concerned with NIH having an equity position  

    Aqualung is working on Unchecked or runaway inflammation in the lungs and body

    Deals with Fibrosis, scar tissue in lungs for example

    ARDS - Acute Respiratory Distress Syndrome - serious lung condition that causes low blood oxygen & fluid in the lungs

    Aqualung Founder is Dr. Joseph Garcia, a physician / scientist who worked in ICU

    Their treatment can help with Covid 19 or Pneumonia 

    Mechanical Ventilation (ventilator) – keeps patient alive, but exacerbates inflammation, 30-40% of death w/ ARDS the long one stays on a ventilator

     

    Aqualung – novel therapies to treat ARDS, with a 1X infusion & reduce inflammation, takes 20 mins. to administer, and can lessen days on a ventilator, saving lives  less days

     

     

    Seg. 2

     

    Covid 19 & ARDS – pneumonia & sepsis hypoxia – less oxygen & oxygenated blood flow, not enough, leads to fluid in lungs (edema), have nasal issues, use C pap machine, but if too severe then need ventilator to help w/ breathing

     

    Pulmonary edema is often caused by congestive heart failure. When the heart is not able to pump efficiently, blood can back up into the veins that take blood through the lungs. As the pressure in these blood vessels increases, fluid is pushed into the air spaces (alveoli) in the lungs.

    Covid – when people have severe Covid, lungs have too much fluid, do not work

    Ventilator increases significant inflammation – too much, storm of bad events, organs fail. Bottome line: Longer on ventilator, the worse things go

    Average ICU stay is 11-15 days for ARDS 

    Aqualung tamps down inflammation, ‘turn dial down’ w/drug, within 6hrs. of diagnosis, Aqualung should be given to a patient

    Reduce inflammation 50% & then reduce time 50% on vent.

    Life & Money saving as 1 day on ventilator = $30k

    Other areas Aqualung can help – fibrosis / Scar tissue in lungs, Covid long syndrome & could be a Radial therapy for cancer treatment 

    Aqualung – tamp down inflammation to Reverse fibrosis, reverse course of diseases 

    Also can assist with - Lupis, inflamed organs, Bowel diseases 

    Aqualung has been funded by Funded by NIH

     

    Seg. 3  

    Aqualung produces Novel therapeutics, that can save lives, and help with breathing disorders or illnesses related to Covid or asthma, or Fibrosis in the lungs, kidney, or cardiac issues 

    Aqualung Therapeutics is agnostic, process can treat all fibrosis as well as help prevent Organ failure. If inflammation or breathing issues persist can lead to failure of liver, kidney, then heart & brain 

    Aqualung eliminated fibrosis in kidneys with testing on animals 

    Improve functions of other organs in pre-clinical models in small & large animals

    Currently doing doses on human volunteers, and will soon be in 8 hospitals in U.S. & 2 in Australia 

    Aqualung needs more funding for research, and is doing a Capital raise 

    Future versions of their treatment could be in different formats, using IV version now in ICU & ER

    Other companies working on this type of research and care are Humira, treatment is a  simple injection monthly 

    Aqualung could be additional therapy for Pulmonary issues, or even a Radial therapy for cancer 

    Multiple forms of delivery are possible  like an in home injection

     

     

     

    Seg. 4

     

    Received $25 million of non dilutive from NIH

    Had to validate their thesis, and was published in 10 publications

     

    Aqualung considered an IND (investigative new drug)

     

    Studies –

    Phase 1 – healthy

    Phase 2 – ARDS patients

    Phase 3 - 2 – 300 patients – large trial

     

    Need funding of $ hundreds millions – for testing IPO or series A-B & C fund raise

    Current trials will be a 5 year process thru 2026

    Overall a 8-10 year process w/ 2-3 year studies, stats (genomics & priobiomics)

     

    MRNA work done years before to create the vaccine for COVID so luckily it was  ready to go in 2020

     

    Alignment on big pharma with this research and application, working in Oncology, immunology, cancer

     

    Fibrosis & immunology – Co’s that can come in are Regeneron, Eli Lilly or Merch

     

    Big Pharma – equity investment has a venture arm within a corporation, to invest in thesis and then pre-human clinical round

    Called the ‘Creeping Acquisition Strategy’ of a smaller company, with incremental investments until own the whole business

     

    ARDS – 500k patients in US dealing with ARDS & $2 mil globally, of which 30-40% will die. ARDS is a multi billion $ year market. ARDS grows 3-5% per year, with funding being a problem, plus other issues like limited therapies

     

    Companies working on the disease, must collaborate with the FDA

    Aqualung – raising funds, $10 mil series A, has $4 mil committed end of phase 1 with FDA meeting.

    Phase 2 study – get rolling & crucial long term, need clinical tests w/ humans

    Phase 1 study w/ animals very successful

     

     

    ** Thanks to Joan Kerber-Walker of AZ Bio for the intro to Stan.

     

    AZ Bio & Life Sciences Innovation w/ Joan Koerber-Walker

    - BRT S04 EP10 (172) 3-5-2023

     

    FULL Show w/ Joan of AZ Bio: Click HERE

     

     

     

    AZ Tech Council Shows: HERE

    *Includes Best of AZ Tech Council show from 2/12/2023

     

    Tech Topic: HERE

    Best of Tech: HERE 

     

    ‘Best Of’ Topic: https://brt-show.libsyn.com/category/Best+of+BRT

     

      

    Thanks for Listening.

    Please Subscribe to the BRT Podcast.

     

     

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    Disclaimer: The views and opinions expressed in this program are those of the Hosts, Guests and Speakers, and do not necessarily reflect the views or positions of any entities they represent (or affiliates, members, managers, employees or partners), or any Station, Podcast Platform, Website or Social Media that this show may air on. All information provided is for educational and entertainment purposes. Nothing said on this program should be considered advice or recommendations in: business, legal, real estate, crypto, tax accounting, investment, etc. Always seek the advice of a professional in all business ventures, including but not limited to: investments, tax, loans, legal, accounting, real estate, crypto, contracts, sales, marketing, other business arrangements, etc.

     

     

    086 ARDS: Respiratory Crisis in Veterinary Medicine

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    Join Yvonne Brandenburg, RVT, VTS SAIM and Jordan Porter RVT, LVT, VTS SAIM as we talk about:

    • ARI/ARDS which means; Acute Respiratory Injury/Acute Respiratory Distress Syndrome. When inflammation starts in the body, sometimes it spreads like wildfire, including to the lungs. Managing these critical cases can be very difficult. 

     

    Question of the Week

     Resources We Mentioned in the Show 

    •  Boysen, S. World Small Animal Veterinary Association World Congress Proceedings (2014).  Acute Respiratory Distress Syndrome. Retrieved from https://www.vin.com/apputil/content/defaultadv1.aspx?id=7054855&pid=12886
    • Ettinger, S. J., Feldman, E. C., Cote, Etienne. (2017). Textbook of Veterinary Internal Medicine (8 ed.). pp. 1120-1121. St. Louis: Elsevier.
    • Merrill, L. (2012). Small Animal Internal Medicine for Veterinary Technicians and Nurses. Ames: Wiley - Blackwell.
    • Silverstein, D., & Hopper, K. (2009). Small Animal Critical Care Medicine. Ch 24. St. Louis: Saunders - Elsevier.



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    Send your questions for Dr. Griffin to daniel@microbe.tv