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Responsive Centered YouTube Video
Discussion on challenges in vaccine regulation and industry transparency with a former regulatory insider.
  • Dr. McMillan and Susan Langwa discuss regulatory issues in the vaccine industry. 0:41

  • Susan Langwa has over 40 years of experience in the biologics industry. 2:50

  • Speaking out against issues within the industry was not encouraged, but Susan did so within her companies. 4:14

  • Susan highlights the risk of being fired or blacklisted for speaking out about confidential concerns. 5:49

  • It is challenging for individuals in the industry to address issues due to fear of repercussions. 6:05

  • Dr. McMillan emphasizes the importance of understanding the difficulties of speaking out in the industry. 6:19

  • 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.
  • Pfizer vaccine has poor efficacy and safety profile, yet highly profitable. 06:58

  • Vaccines were believed to be safe and effective, but Pfizer vaccine failed to meet expectations. 07:51

  • Serious adverse events from Pfizer vaccine reported in trials and real-world data. 08:31

  • Evidence of Pfizer vaccine potentially causing heart attacks and cardiac arrest. 08:56

  • Pharmaceutical companies prioritize profits over patient safety. 09:28

  • Regulators, doctors, and medical journals collude with industry for financial gain. 09:48

  • Call for stricter regulations with large fines and criminal liability for pharmaceutical companies. 10:19

  • 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.
  • Vaccine manufacturers initially operated at a loss due to low prices and distribution through organizations like UNICEF. 12:20

  • Government intervention in the 70s and 80s helped sustain vaccine companies financially. 13:01

  • Liability concerns led to the removal of legal suits against vaccine manufacturers in the 80s. 15:09

  • Shareholder influence increased in the 90s, prompting mergers and acquisitions to streamline the industry. 15:32

  • 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.
  • Biologics are heavily regulated with annual inspections by multiple countries. 16:56

  • Introduction of fee structure for regulatory services added to vaccine production costs. 17:25

  • Pressure from shareholders and governments influenced vaccine development and approval. 18:36

  • Lack of clear accountability and responsibility in the vaccine industry. 19:00

  • Society’s expectations and blame culture contributing to rushed decision-making during the pandemic. 20:27

  • 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.
  • Development of mRNA vaccines raised concerns about long-term effects and data gaps in specific populations. 22:31

  • Government approval of vaccines for all despite missing data on pregnant women and autoimmune conditions. 24:53

  • Individual responsibility in researching vaccine information and making informed decisions. 25:22

  • Fear and misinformation led many to overlook potential risks and rely solely on official recommendations. 26:00

  • Advice to vulnerable groups to consider vaccination while acknowledging uncertainties in safety and efficacy. 26:26

  • 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.
  • Challenges in vaccine distribution to different age groups with varying risk-benefit profiles. 28:50

  • Pharmaceutical companies facing dilemmas in vaccine development for vulnerable populations. 29:49

  • Concerns over emergency drug release without full consent information for recipients. 31:04

  • Debate on pharmaceutical companies’ responsibility in case of issues with their products. 32:26

  • Questioning the feasibility of holding senior company officials criminally liable for product issues. 32:37

  • Exploration of regulations for misbranding and inappropriate marketing of pharmaceutical products. 33:03

Responsibility and accountability in COVID-19 vaccine regulation and industry practices.
  • Company heads should be held accountable for regulatory compliance. 33:17

  • Challenges in assigning accountability due to complex decision-making processes. 34:22

  • Pharma industry reputation affected by companies exploiting new technologies for financial gain. 36:02

  • Differentiation needed between companies utilizing responsible practices and those taking advantage of the situation. 37:33

  • Belief in the efficacy of mRNA technology but caution in its application to diseases like COVID-19. 37:48

  • 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.
  • Mention of using mRNA for pancreatic cancer trials 39:24

  • Challenges with controlling antigen dose in mRNA vaccines 40:47

  • Significant variation in antibody levels post-vaccination in older age groups 41:45

  • Lack of transparency in monitoring and submitting vaccine studies to regulators 42:37

  • Questioning the rush to market mRNA technology during a pandemic 43:27

  • Limited approval history of mRNA technology for mass vaccinations 43:32

  • 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.
  • Long-standing vaccines like polio and tetanus are trusted due to known safety and efficacy. 44:52

  • New vaccine technologies raise questions about safety and efficacy, especially in urgent situations. 45:14

  • Challenges in attributing reduced deaths solely to COVID-19 vaccines due to other factors like treatments and behavior changes. 45:46

  • Importance of controlled clinical trials for accurate assessment of vaccine effectiveness and safety. 46:42

  • Personal experience of maintaining health without vaccination through precautions and natural immunity. 47:28

  • Comparison of adverse events between COVID-19 vaccines and traditional vaccines like polio, highlighting perceived risks. 48:05

  • 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.
  • Lack of communication about risks in pharmaceutical products. 49:16

  • Silence in the pharmaceutical industry as a contributing factor to current issues. 50:12

  • Fear of repercussions for speaking out against industry practices. 51:06

  • Encouragement for more people to speak out and share their concerns. 52:00

  • Importance of listening to experts and not just politicians. 53:51

  • Experts facing backlash for raising difficult issues. 54:19

Discussion on accountability in vaccine regulation and the importance of making informed decisions.
  • Emphasis on moving beyond blame and considering what is best for everyone 54:51

  • Suggesting the need to improve decision-making processes 55:06

  • Expressing gratitude to participants and addressing comments 55:13

  • Closing remarks and thanking the guest speaker 55:27