Discussion on challenges in vaccine regulation and industry transparency with a former regulatory insider.
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Dr. McMillan and Susan Langwa discuss regulatory issues in the vaccine industry. • 0:41
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Susan Langwa has over 40 years of experience in the biologics industry. • 2:50
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Speaking out against issues within the industry was not encouraged, but Susan did so within her companies. • 4:14
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Susan highlights the risk of being fired or blacklisted for speaking out about confidential concerns. • 5:49
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It is challenging for individuals in the industry to address issues due to fear of repercussions. • 6:05
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Dr. McMillan emphasizes the importance of understanding the difficulties of speaking out in the industry. • 6:19
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The discussion on Fox News with Dr. Malhotra prompts a deeper look into industry transparency and accountability. • 6:29
Issues with Pfizer vaccine safety and efficacy, pharmaceutical industry profit motives, and the need for stricter regulations.
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Pfizer vaccine has poor efficacy and safety profile, yet highly profitable. • 06:58
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Vaccines were believed to be safe and effective, but Pfizer vaccine failed to meet expectations. • 07:51
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Serious adverse events from Pfizer vaccine reported in trials and real-world data. • 08:31
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Evidence of Pfizer vaccine potentially causing heart attacks and cardiac arrest. • 08:56
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Pharmaceutical companies prioritize profits over patient safety. • 09:28
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Regulators, doctors, and medical journals collude with industry for financial gain. • 09:48
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Call for stricter regulations with large fines and criminal liability for pharmaceutical companies. • 10:19
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Acknowledgment of vaccine-injured individuals and the need to address their care and support. • 11:07
Evolution of vaccine regulation and industry from nonprofit to profit-driven shareholder model.
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Vaccine manufacturers initially operated at a loss due to low prices and distribution through organizations like UNICEF. • 12:20
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Government intervention in the 70s and 80s helped sustain vaccine companies financially. • 13:01
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Liability concerns led to the removal of legal suits against vaccine manufacturers in the 80s. • 15:09
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Shareholder influence increased in the 90s, prompting mergers and acquisitions to streamline the industry. • 15:32
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Rising population and regulatory demands in the 2000s drove up vaccine production costs. • 16:41
Complexities in vaccine regulation and accountability leading to a messy situation during the pandemic.
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Biologics are heavily regulated with annual inspections by multiple countries. • 16:56
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Introduction of fee structure for regulatory services added to vaccine production costs. • 17:25
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Pressure from shareholders and governments influenced vaccine development and approval. • 18:36
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Lack of clear accountability and responsibility in the vaccine industry. • 19:00
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Society’s expectations and blame culture contributing to rushed decision-making during the pandemic. • 20:27
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Challenges in balancing speed and safety during emergency vaccine approvals. • 22:12
Challenges in assessing COVID-19 vaccine safety and efficacy due to lack of long-term data and varying information sources.
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Development of mRNA vaccines raised concerns about long-term effects and data gaps in specific populations. • 22:31
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Government approval of vaccines for all despite missing data on pregnant women and autoimmune conditions. • 24:53
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Individual responsibility in researching vaccine information and making informed decisions. • 25:22
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Fear and misinformation led many to overlook potential risks and rely solely on official recommendations. • 26:00
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Advice to vulnerable groups to consider vaccination while acknowledging uncertainties in safety and efficacy. • 26:26
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Challenges in distinguishing between reliable and misleading information sources, causing confusion among the public. • 27:35
Discussion on vaccine regulation challenges, including lack of consent and liability issues.
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Challenges in vaccine distribution to different age groups with varying risk-benefit profiles. • 28:50
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Pharmaceutical companies facing dilemmas in vaccine development for vulnerable populations. • 29:49
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Concerns over emergency drug release without full consent information for recipients. • 31:04
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Debate on pharmaceutical companies’ responsibility in case of issues with their products. • 32:26
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Questioning the feasibility of holding senior company officials criminally liable for product issues. • 32:37
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Exploration of regulations for misbranding and inappropriate marketing of pharmaceutical products. • 33:03
Responsibility and accountability in COVID-19 vaccine regulation and industry practices.
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Company heads should be held accountable for regulatory compliance. • 33:17
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Challenges in assigning accountability due to complex decision-making processes. • 34:22
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Pharma industry reputation affected by companies exploiting new technologies for financial gain. • 36:02
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Differentiation needed between companies utilizing responsible practices and those taking advantage of the situation. • 37:33
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Belief in the efficacy of mRNA technology but caution in its application to diseases like COVID-19. • 37:48
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Skepticism towards COVID-19 vaccine effectiveness due to the nature of the disease as a viral-mediated autoimmune response. • 38:14
Concerns raised about mRNA vaccine technology, dosing control, and regulatory oversight.
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Mention of using mRNA for pancreatic cancer trials • 39:24
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Challenges with controlling antigen dose in mRNA vaccines • 40:47
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Significant variation in antibody levels post-vaccination in older age groups • 41:45
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Lack of transparency in monitoring and submitting vaccine studies to regulators • 42:37
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Questioning the rush to market mRNA technology during a pandemic • 43:27
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Limited approval history of mRNA technology for mass vaccinations • 43:32
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Concerns about the rationale behind utilizing mRNA technology in a pandemic scenario • 44:01
Concerns regarding new vaccine technologies, lack of long-term data, and potential adverse effects.
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Long-standing vaccines like polio and tetanus are trusted due to known safety and efficacy. • 44:52
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New vaccine technologies raise questions about safety and efficacy, especially in urgent situations. • 45:14
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Challenges in attributing reduced deaths solely to COVID-19 vaccines due to other factors like treatments and behavior changes. • 45:46
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Importance of controlled clinical trials for accurate assessment of vaccine effectiveness and safety. • 46:42
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Personal experience of maintaining health without vaccination through precautions and natural immunity. • 47:28
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Comparison of adverse events between COVID-19 vaccines and traditional vaccines like polio, highlighting perceived risks. • 48:05
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Discussion on the need for transparent communication about potential vaccine side effects to the public. • 49:05
The importance of speaking out against pharmaceutical industry practices and the consequences of remaining silent.
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Lack of communication about risks in pharmaceutical products. • 49:16
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Silence in the pharmaceutical industry as a contributing factor to current issues. • 50:12
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Fear of repercussions for speaking out against industry practices. • 51:06
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Encouragement for more people to speak out and share their concerns. • 52:00
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Importance of listening to experts and not just politicians. • 53:51
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Experts facing backlash for raising difficult issues. • 54:19