Could Big Pharma Suffer Permanent Damage from Selective Silence?

Headley has extensive experience in big pharma and biotech, specializing in supply chains and drug development. • 2:49

He authored a textbook on supply chain management in the drug industry and is working on a new book on transforming pharmaceutical supply chains. • 4:37

Despite facing censorship and backlash, Headley continues to speak out against industry practices and advocates for patient-centered approaches. • 6:03

He criticizes the industry for prioritizing profits over patient care and healthcare professionals, calling for a shift in focus. • 6:57

Pharmaceutical industry lacks value for money, faces challenges from outsourcing to China and India. • 7:03

Industry incentivized to maintain status quo with a ‘find it, file it, flog it’ model. • 9:04

Vertical integration in pharmaceutical companies has shifted to a fragmented industry with contract manufacturers. • 10:45

Pfizer and BioNTech collaboration on mRNA vaccine exemplifies biotech company selling to big Pharma. • 12:20

Companies must reach critical mass to bring drugs to market safely. • 13:13

Initial drug batches from a Pfizer plant in Massachusetts were substandard. • 13:49

Failure to adhere to good manufacturing practices can lead to harmful side effects. • 14:42

Example of Baxter’s toxic material substitution resulting in deaths and adverse events. • 16:04

Importance of supply chain integrity highlighted by past incidents. • 17:08

Challenges in scaling up drug production highlighted by the need for small supply chains in early stages. • 18:46

Drug development process involves testing in animal models before moving to human trials. • 19:03

Typically, drug development process takes three years due to safety testing requirements. • 19:27

COVID-19 vaccine development bypassed some safety testing steps to expedite the process. • 20:59

Manufacturing is the longest part of drug development due to supplier contracts and quality agreements. • 21:20

Roll and reveal approach used for COVID-19 vaccine approval focused only on clinical studies. • 22:12

Scaling up in drug development can lead to changes in compound composition and safety risks. • 23:01

mRNA technology in COVID-19 vaccines involves starting materials like cells meeting specific specifications. • 24:20

Pharmaceutical manufacturing involves thorough auditing and inspection of suppliers. • 24:57

Process includes handling live organisms with extreme care and long lead times. • 26:10

Manufacturing sites may involve multiple locations and transportation of materials. • 26:28

Challenges in maintaining control and quality at manufacturing sites have been observed by FDA. • 28:40

Vaccination centers are responsible for completing the manufacturing process before distribution. • 30:06

Pharmaceutical companies did not adhere to established regulations during drug development and distribution. • 30:43

Lack of legal enforcement on pharmaceutical companies for breaking regulations. • 32:29

Global distribution contracts between governments and pharmaceutical companies bypassed military involvement. • 33:16

Confusion and overlap in responsibilities among regulatory bodies in different countries. • 34:17

Inconsistencies in drug approval processes with multiple bodies involved in decision-making. • 35:06

Concerns about the approval process for advanced therapy medicinal products in the UK. • 36:18

Hospital pharmacies in the UK can now manufacture gene therapies for blood cancers. • 36:45

Gene therapies, like mRNA technology, require close monitoring due to potential side effects. • 38:00

Pharmaceutical companies must promptly investigate and address serious adverse events related to their products. • 41:52

Regulators focus on inspecting companies’ pharmacovigilance processes rather than directly monitoring adverse events. • 42:27

Pharmaceutical industry facing risks from lack of transparency and fragmented drug development process. • 43:00

Comparison to Toyota incident highlighting the importance of swift resolution to maintain customer trust. • 43:10

Concerns about pharmacovigilance failure impacting the entire industry. • 44:33

Fragmentation of big Pharma leading to a broken drug development system. • 45:15

High attrition rate in drug development process leading to significant costs of failure. • 46:47

Prediction of potential collapse of big Pharma and domino effect on financial markets. • 47:00

Outsourcing drug development process leading to inability to satisfy customers and declining Blockbuster drugs. • 48:08

Concerns raised about the integrity of drug development and lack of scientific rigor in the pharmaceutical industry. • 48:50

Potential domino effect on related industries and stock markets if major pharmaceutical companies face legal consequences. • 49:15

Questioning the unrealistic expectations set for vaccine efficacy and the need for reevaluation of current strategies. • 50:07

Limited scientific basis in drug development, with heavy reliance on technology, engineering, and applied sciences. • 51:29

History of failed drug developments, such as in Alzheimer’s disease, raises concerns about the industry’s approach to innovation. • 52:29

Persistent pursuit of ineffective theories and lack of evidence-based practices in pharmaceutical research. • 53:31

Comparison to past successful drug developments like penicillin highlights the importance of evidence-based medicine over speculative theories. • 53:53

Likelihood of pharmaceutical industry repeating similar patterns of prioritizing profit over scientific integrity in the future, especially with mRNA technology. • 54:23

Need to involve physicians and doctors in drug development to ensure effectiveness and safety. • 54:51

Historical example of penicillin discovery highlights the importance of medical expertise in drug development. • 55:37

Concerns about the current state of the pharmaceutical industry and the need for reform. • 56:41

Public awareness of the shortcomings in the scientific and medical fields is increasing. • 57:03

Challenges posed by ongoing virus circulation and the emergence of new variants despite high vaccination rates. • 57:30

Comparison of the pharmaceutical industry to an addict needing intervention and support for rehabilitation. • 58:03

Call for collaboration among medical professionals, experts, and authorities to address industry challenges and find solutions. • 59:36

Recognition of key figures and organizations advocating for reform in the pharmaceutical industry. • 1:00:07

Discussion on challenges in the industry and need for different leaders and thinkers. • 1:00:50

Acknowledgment of the critical transition point the world is facing. • 1:01:04

Urgency in finding solutions for the pandemic to prevent severe impacts on lives and industries. • 1:01:13

Importance of essential industries for delivering quality healthcare worldwide. • 1:01:30

Appreciation for the insightful and informative discussion. • 1:01:39

Encouragement to stay informed and lookout for future presentations. • 1:01:47

Gratitude for the participation and invitation to the audience. • 1:01:53