Big Pharma EXPOSED w/ Dr. John Abramson | PBD Podcast Ep. 351
In the PBD Podcast’s latest thought-provoking instalment, host Patrick Bet-David along with renowned speakers Dr. John Abramson and Tom Ellsworth tackle the opaque realms of Big Pharma. Navigating the muddied waters of pharmaceutical transparency, Dr. Abramson exposes the disturbing deficiency in independent data analysis—a critical issue that compels clinicians to depend on possibly skewed information. With sharp insights rooted in legal experiences with pharma litigation, Abramson raises the alarm about the industry's iron grip over proprietary data, thus pitting profit against public health. A call for a truth standard akin to that of the financial sector bolsters this critical discussion on corporate accountability.
The trio delves deeper into the healthcare quagmire, scrutinizing flagrant conflicts of interest that taint research funding and publications; an example being the financial ties of medical leaders like Harvard’s Provost Alan Garber to pharmaceutical boards. The conversation transitions to the alarming costs of medication in the U.S., poised precariously on the edge of prolific advertising and low regulatory constraints. As they dissect the inconsequential penalties facing Big Pharma's misconduct, Dr. Abramson highlights a pressing concern—and public apprehension—surrounding the hasty approval and promotion of COVID-19 vaccines and boosters, highlighting the stark lack of substantial safety data and efficacy evaluations. This episode promises an unflinching look at the urgent need for reform within pharmaceutical governance and practices.
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1-Page Summary
Transparency and Access to Real Data from Pharmaceutical Companies
Dr. John Abramson emphasizes the lack of transparency in the pharmaceutical industry, explaining that clinicians are often forced to rely on data that has not been independently analyzed. He criticizes the practice of using data owned and curated by drug companies, which may prioritize profit over public welfare. Abramson points out the difficulty of accessing true data and the reliance on information provided by pharmaceutical companies, which peer reviewers and medical journals use without independent analysis. Through his experience with pharmaceutical litigation, Abramson has seen how companies maintain exclusive control over data, limiting its use for marketing rather than public health improvements. He advocates for the pharmaceutical industry to be held to similar standards of truthfulness as the financial sector.
Conflicts of interest in pharmaceutical industry funding of research and publications
Dr. Abramson discusses the deep-seated conflicts of interest present in the pharmaceutical industry's funding of research and publications. He focuses on the example of Harvard Medical School Provost Alan Garber, who receives more income from pharmaceutical board memberships than from his university position, highlighting the potential influence on medical education and healthcare policy. Garber's ties to Vertex Pharmaceuticals raise questions about motivations in healthcare decision-making. These conflicts of interest, Abramson suggests, compromise the objectivity of medical research.
High US drug prices and profits compared to other countries
The high cost of drugs in the United States is partly attributed to the significant money spent on pharmaceutical advertising. Bet-David notes that the U.S. is unique in allowing direct-to-consumer advertising of pharmaceuticals, suggesting that the prohibition of such advertising might negatively impact industry profits.
Lack of accountability and consequences for harms caused by pharma products and policies
The pharmaceutical industry's practice of paying massive fines for illegal activities is criticized for its lack of deterrence. Dr. Abramson argues that these fines are treated as the cost of doing business and highlights that not enough is done to hold individuals responsible for such activities. He provides the example of Pfizer, where a subsidiary took the hit, sparing the parent company and its executives from more severe consequences. The current penalties fail to discourage corporate misbehavior or hold individuals within these organizations accountable.
COVID-19 vaccines lack long-term safety data and adequate effectiveness evaluations
Dr. Abramson raises concerns about the regulatory processes for COVID-19 vaccine boosters, noting the absence of long-term safety data and rigorous effectiveness evaluations. He criticizes the FDA's approval of boosters without randomized controlled trials, relying instead on limited antibody data from animal studies. Abramson expresses discomfort with the collection and interpretation of supporting data, suggesting that electronic medical records may yield flawed comparisons. Additionally, he criticizes public health authorities and experts for overemphasizing the vaccines' merits without adequate evidence. Abramson seeks more robust data to support medical interventions and questions the swift marketing and distribution of boosters during a health crisis.
1-Page Summary
Additional Materials
Clarifications
- In the pharmaceutical industry, lack of transparency refers to the limited access to unbiased data and information about drugs and medical products. This opacity can stem from companies controlling and selectively sharing data, potentially prioritizing profits over public health. It can lead to challenges in independently verifying the safety and efficacy of medications, impacting medical decision-making and patient outcomes. Critics argue for increased transparency to ensure that healthcare professionals and the public have access to accurate and comprehensive information.
- Conflicts of interest in pharmaceutical industry funding occur when financial relationships between drug companies and researchers may influence research outcomes or publications. These ties can potentially bias study results or decision-making processes in favor of the funder's interests. Transparency and disclosure of these relationships are crucial to maintaining the integrity and credibility of medical research and healthcare practices. Researchers and institutions must navigate these conflicts carefully to uphold ethical standards and ensure unbiased scientific inquiry.
- High drug prices in the United States are influenced by various factors, including the significant spending on pharmaceutical advertising. Direct-to-consumer advertising is allowed in the U.S., which is not the case in many other countries. This advertising can drive up demand for specific drugs, leading to higher prices. The impact of advertising on drug prices is a complex issue that involves considerations of market dynamics, consumer behavior, and regulatory frameworks.
- The lack of accountability for harms caused by pharmaceutical products often involves companies paying fines for illegal activities without facing significant consequences. Individuals within these organizations are not always held responsible for misconduct, leading to a perception that fines are merely a cost of doing business. This lack of deterrence can fail to discourage corporate misbehavior and may result in limited repercussions for harmful actions. In some cases, subsidiaries may bear the brunt of penalties, shielding the parent company and its executives from more severe accountability measures.
- Dr. Abramson raises concerns about the lack of long-term safety data for COVID-19 vaccines and questions the rigorousness of effectiveness evaluations, particularly regarding booster shots. He criticizes the approval process for boosters, highlighting the reliance on limited data and the absence of randomized controlled trials. Abramson emphasizes the need for more robust data to support medical interventions during a health crisis like the COVID-19 pandemic.
Counterarguments
- Pharmaceutical companies argue that data confidentiality is necessary to protect intellectual property and competitive advantage, which incentivizes innovation and the development of new drugs.
- The industry contends that it adheres to rigorous regulatory standards and that data transparency is balanced with the need to protect patient privacy and proprietary information.
- It is argued that conflicts of interest can be managed with proper disclosure and oversight, and that industry-academia collaborations are essential for advancing medical research.
- Some argue that high drug prices in the US fund research and development that benefits patients worldwide, and that price controls could stifle innovation.
- The industry often points out that the legal and regulatory framework provides mechanisms for accountability, and that fines are part of a broader set of tools to ensure compliance.
- Proponents of the COVID-19 vaccines emphasize the unprecedented speed of development and the robustness of the emergency use authorization process during a global health crisis.
- Public health authorities and experts argue that the benefits of COVID-19 vaccines have been demonstrated through real-world effectiveness studies and that the risk-benefit analysis justifies their use.
- The FDA and other regulatory bodies maintain that their decisions are based on the totality of the evidence available and that they continuously monitor the safety and effectiveness of vaccines.
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Transparency and Access to Real Data from Pharmaceutical Companies
Dr. John Abramson raises concerns about the opacity surrounding the pharmaceutical industry’s research data, which impacts the capacity of healthcare professionals to make informed decisions.
SEC filings show data is owned by drug companies to maximize profits, not improve public health
Abramson highlights a concerning chasm between the data that clinicians rely upon for evidence-based medicine and the information that is actually available for independent analysis. He emphasizes that the true data that would inform doctor's conclusions remain inaccessible, leaving many to make recommendations based on non-vetted data. He goes on to say that one must be involved in litigation to directly access this data.
Committees of Medical Journal Editors rely on drug company data which is not independently analyzed
Abramson points out that peer reviewers for respected medical journals do not see the actual data from clinical studies. The reviewers only access information presented in manuscripts, which precludes thorough and independent analysis. This system allows for the possibility of drug companies influencing research, guidelines, and prescribing practices since clinical practice guidelines — which doctors are expected to follow — are based on these non-independently verified studies.
Lack of data transparency enables pharmaceutical industry influence over research, guidelines, and prescribing practices
Abramson takes issue with the fact that the foundation of peer-reviewed articles in medicine rests upon such non-transparent practices. He illustrates the gravity of the situation by referring to an article from the New England Journal of Medicine that reported drug companies having contractual rights to write up research results. Furthermore, he discusses the Centers for Medicare & Medicaid Services' (CMS) decision not to cover a new Alzheimer's drug unless it is monitored through a registry, noting that the FDA often approves drugs based on statistical significance rather than clinical benefit. He scrutinizes AllsNet, a drug ...
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Transparency and Access to Real Data from Pharmaceutical Companies
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Clarifications
- SEC filings are documents submitted to the U.S. Securities and Exchange Commission (SEC) by publicly traded companies. These filings provide detailed financial and operational information about the company, including ownership structure, executive compensation, financial performance, and potential risks. For pharmaceutical companies, SEC filings can offer insights into their business strategies, revenue sources, research and development activities, and regulatory compliance. Analyzing SEC filings can help investors, regulators, and stakeholders assess the financial health and transparency of pharmaceutical companies.
- The Committees of Medical Journal Editors are groups responsible for setting standards and guidelines for medical journals. They play a crucial role in ensuring the quality and integrity of published research by establishing criteria for publication. These committees help maintain the credibility of medical literature by overseeing the peer review process and ethical considerations in research publication. Their involvement helps uphold the standards of transparency and accuracy in disseminating medical information.
- Clinical practice guidelines are recommendations for healthcare professionals on the best ways to diagnose and treat various medical conditions. These guidelines are often based on evidence from clinical studies and research. When these guidelines rely on studies that have not been independently verified, there is a risk that the information presented may be influenced by the interests of pharmaceutical companies rather than solely focusing on patient outcomes. This can potentially lead to biased recommendations and impact the quality of care provided to patients.
- The Centers for Medicare & Medicaid Services (CMS) is a federal agency that administers the Medicare and Medicaid programs in the United States. CMS evaluates new medical treatments and decides whether they will be covered by these programs based on factors like clinical effectiveness and cost. In the context of the text, CMS's decision not to cover a new Alzheimer's drug unless it is monitored through a ...
Counterarguments
- Pharmaceutical companies argue that data exclusivity is necessary to protect intellectual property and incentivize the costly and risky process of drug development.
- Industry representatives might claim that data is proprietary and releasing it could compromise competitive advantage and commercial interests.
- Some argue that the current peer review process, while not perfect, is a robust method of ensuring the quality and integrity of published research.
- It could be argued that the FDA and other regulatory bodies provide sufficient oversight to ensure that drugs are safe and effective, even if all data is not publicly available.
- There may be concerns about patient privacy and the ethical implications of sharing raw clinical trial data.
- Drug companies might assert that they do adhere to high standards of truthfulness and that any lack of transparency is not intended to mislead but to protect sensitive information.
- Some might argue that the pharmaceutical industry is highly regulated and that companies are legally required to disclose all relevant data to regulatory authorities.
- It could be pointed out that there are mechanisms i ...
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Conflicts of interest in pharmaceutical industry funding of research and publications
Dr. John Abramson revealed concerns about pervasive conflicts of interest in the pharmaceutical industry, particularly in how these companies fund research and publications that can shape medical education and healthcare policy.
Provost of Harvard Medical School paid more from pharma boards than university role
A striking example of how deep pharmaceutical ties can run within the academic world is provided by the case of Alan Garber, the provost of Harvard Medical School. Despite his critical academic role, Garber's financial ties to the pharmaceutical industry have recently come under scrutiny.
Allows pharma to influence medical education and healthcare policy
Abramson points out that Garber receives a very substantial salary of about $940,000 annually from Harvard. However, since assuming board memberships at two pharmaceutical companies in 2017, Garber has earned even more from these positions—$960,000, exceeding his university income. The implications of these financial ties are significant and troubling given the potential influence over medical education and healthcare policy decisions.
One of the companies Garber is invo ...
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Conflicts of interest in pharmaceutical industry funding of research and publications
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Clarifications
- Alan Garber, the provost of Harvard Medical School, receives a substantial salary from Harvard. In addition to his university income, he also earns money from board memberships at two pharmaceutical companies. The total income from these board positions exceeds his salary from Harvard. One of the companies he is associated with, Vertex Pharmaceuticals, has faced criticism for the pricing of one of its drugs.
- The pricing of Vertex Pharmaceuticals' cystic fibrosis drug at $322,000 compared to manufacturing costs of less than $6,000 highlights a significant disparity. This discrepancy raises concerns about the profit margins and pricing strategies employed by pharmaceutical companies. It underscores the potential conflicts of interest that can arise when high drug prices intersect with public health considerations. Such situations can lead to questions about the balance between profitability and accessibility in healthcare.
- Financial ties between individuals in academic positions and pharmaceutical companies can create conflicts of interest that may influence medical education and healthcare policy decisions. When influential figures receive significant financial compensation from pharmaceutical companies, there is a risk that their decisions and actions could be swayed by these financial interests. This can potentially impact the integrity and objectivity of medical research, as well as the development of healthcare policies that are meant to prioritize public health over corporate interests. Transparency and ethical guidelines are crucial in managing these financial relat ...
Counterarguments
- Financial ties do not necessarily equate to undue influence or bias; individuals can maintain professional integrity despite such ties.
- Compensation from pharmaceutical boards for experts like Garber may reflect the value of their expertise and contribution to the industry, rather than an attempt to exert influence.
- High drug prices can be attributed to factors beyond simple manufacturing costs, such as research and development expenses, regulatory hurdles, and the need to fund future innovative treatments.
- The presence of industry professionals in academic roles can foster beneficial collaborations that advance medical research and innovation.
- Conflict of interest policies and transparency requirements are often in place to mitigate the potential for undue influence on medical education and policy.
- The high compensation from pharmaceuti ...
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High US drug prices and profits compared to other countries
Bet-David sheds light on the unique situation in the United States concerning pharmaceutical advertising and its potential link to the high cost of drugs.
US only country allowing pharma direct-to-consumer advertising
Bet-David addresses the significant amounts of money pharmaceutical companies spend on advertising. He discusses the unique stance of the United States as the only country that allows direct-to-consumer pharmaceutical advertising. This ...
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High US drug prices and profits compared to other countries
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Clarifications
- Pharmaceutical advertising in the US can influence consumer demand, leading to higher prescription drug sales and prices. Direct-to-consumer advertising can create a pull effect, prompting patients to request specific medications from their healthcare providers. This demand-driven market dynamic can contribute to sustained high drug prices in the US compared to countries where such advertising is restricted. The relationship between advertising, demand generation, and pricing is a complex interplay that impacts the pharmaceutical industry's revenue and pricing strategies.
- Direct-to-consumer pharmaceutical advertising is a marketing strategy where drug companies promote prescription drugs directly to consumers through various media channels. In the United States, this practice is allowed, meaning drug companies can advertise their products to the general public. This is different from many other countries where such advertising is restricted or prohibited, with regulations often limiting drug promotion to healthcare professionals only. The U.S. approach has been a subject of debate due to concerns about its impact on healthcare costs, patient-doctor relationships, and the appropriateness of consumer-targeted drug marketing.
- Prohibiting dire ...
Counterarguments
- Direct-to-consumer advertising can increase awareness about treatments and encourage patients to seek medical advice, potentially leading to better health outcomes.
- Prohibiting direct-to-consumer advertising might not necessarily lead to lower drug prices, as there are multiple factors contributing to the cost of pharmaceuticals, including research and development expenses, regulatory hurdles, and the complexity of the American healthcare system.
- High drug prices in the US could also be attributed to the country's strong patent protections and market exclusivity periods, which allow drug manufacturers to recoup their investments before generics enter the market.
- The relationship between adver ...
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Lack of accountability and consequences for harms caused by pharma products and policies
The discussion suggests that pharmaceutical companies, such as Pfizer in 2009, have paid massive fines for illegal activities but continue such practices without significant consequences, pointing to a systemic issue of lack of accountability in the industry.
Massive fines treated as cost of business instead of deterrent of future behavior
Abramson points out that these fines, including those for off-label promotion and kickbacks, do not deter future illegal behavior, suggesting that big pharma treats such penalties as mere costs of doing business. The actual impact of these fines is minimized, which leads to a continuation of undesirable practices without fear of severe repercussions.
Individuals not held responsible for pharma illegal activities
When Pfizer was fined, it was a subsidiary that took the brunt of the legal and financial fallout, effectively shielding the parent company from more serious consequences like exclusion from Medicare. This maneuver reveals a lack of pe ...
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Lack of accountability and consequences for harms caused by pharma products and policies
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Clarifications
- Off-label promotion in the pharmaceutical industry involves marketing a drug for uses not approved by regulatory agencies. Kickbacks are illegal incentives given to healthcare providers to promote or prescribe specific medications. These practices can lead to inappropriate prescribing, potential health risks for patients, and legal consequences for companies involved.
- When a subsidiary takes the brunt of legal and financial consequences, it shields the parent company from severe penalties. This practice helps protect the parent company's reputation and f ...
Counterarguments
- Fines are part of a broader regulatory and legal framework designed to ensure compliance and can lead to improved practices over time.
- Pharmaceutical companies often operate within complex legal and regulatory environments, and some violations may be the result of unclear guidelines rather than intentional wrongdoing.
- The size of the fines must be balanced against the potential to unduly punish shareholders and employees who were not involved in the wrongdoing.
- Legal strategies, such as subsidiaries taking responsibility, can be legitimate corporate structures to manage risk and are not necessarily intended to evade accountability.
- Personal accountability for executives could have a chilling effect on the industry, potentially discouraging innovation and risk-taking that can lead to important medical breakthroughs.
- Excluding companies from Medicare could harm patients by limiting access to essential medications.
- The pharmaceutical industry is subject to intense scrutiny and regulation, and i ...
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COVID-19 vaccines lack long-term safety data and adequate effectiveness evaluations
Dr. John Abramson highlights significant concerns about the evaluation and regulatory processes of COVID-19 vaccine boosters, particularly the absence of long-term safety data and a reliance on inadequate data for effectiveness assessments.
Repeat boosters approved without randomized controlled trials
Public health establishment overpromotion based on inadequate data
Dr. John Abramson has voiced strong concerns over the approval and usage of COVID-19 vaccine boosters. He states that the Food and Drug Administration (FDA) has been sanctioning COVID-19 vaccine boosters without the support of randomized controlled trials (RCTs), which are the gold standard for evaluating the safety and efficacy of medical interventions.
Abramson cites the second booster approval using only antibody data and observational data as insufficient, lacking the rigor and reliability of RCTs. He particularly highlights that the Pfizer vaccine booster was approved based on antibody data from only eight mice and Moderna's on data from ten mice. Citing his health condition, Abramson expresses unease about the lack of data concerning the safety of the vaccines.
Abramson is also critical of the methods used to collect and interpret the data supporting booster approval. He points out that using harvested electronic medical records to gauge death rates from COVID among those who received the booster against those who did not can produce flawed results due to the inherent health differences between the compared groups.
Moreover, Abramson condemns the approach taken by both the Centers for Disease Control and Prevention (CDC) and public health experts who advocate on television for the COVID-19 vaccine boosters. He claims ...
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COVID-19 vaccines lack long-term safety data and adequate effectiveness evaluations
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Clarifications
- An RCT (randomized controlled trial) is a type of scientific study that compares different treatments by randomly assigning participants to each treatment group. This random allocation helps control for various factors that could influence the study outcomes. RCTs are considered the gold standard in clinical research for evaluating the effectiveness and safety of medical interventions. They aim to minimize biases and provide reliable evidence on the benefits and risks of treatments.
- Antibody data is information about the presence and levels of antibodies in response to a vaccine or infection. Observational data involves studying outcomes in real-world settings without intervention. In this context, the approval of booster shots based on antibody data and observational data means that decisions were made using information about antibody levels and real-world observations of vaccine effectiveness, rather than data from controlled experiments like randomized controlled trials.
- Dr. Anthony Fauci is the Director of the National Institute of Allergy and Infectious Diseases (NIAID) in the United States. He has been a prominent figure in advising the government on public health matters, including during the COVID-19 pandemic. Fauci has made statements supporting COVID-19 vaccination efforts and public health measures, often appearing in media to communicate guidance and updates to the public. His role involves providing expert advice on infectious diseases and helping shape national responses to health crises.
- Electronic medical records (EMRs) are digital versions of paper charts used by healthcare providers to store patient health information. In the context of evaluating booster effects, EMRs can be utilized to track and analyze data related to outcomes and adverse events in individuals who have received COVID-19 vaccine boosters. By examining EMRs, researchers and public health authorities can assess factors like hospital ...
Counterarguments
- COVID-19 vaccines have undergone rigorous short-term safety evaluations and have been monitored for adverse effects through multiple surveillance systems.
- The urgency of the pandemic necessitated expedited approval processes, which were based on the best available evidence at the time to save lives.
- The effectiveness of COVID-19 vaccines in preventing severe disease, hospitalization, and death has been demonstrated in real-world studies.
- The use of observational data and real-world evidence is a valid scientific approach, especially when RCTs are not feasible or ethical during a public health emergency.
- Antibody data, while not a complete measure of immunity, can provide valuable insights into the potential efficacy of vaccine boosters.
- The FDA and other regulatory agencies have processes for emergency use authorization that balance the need for rapid response with the need for evidence of safety and effectiveness.
- Public health recommendations, including those made by Dr. Anthony Fauci, are often based on a consensus of the current understanding of the science, which can evolve over time.
- Vaccine mandates have been impleme ...
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1-Page Summary- Transparency and Access to Real Data from Pharmaceutical Companies
- Conflicts of interest in pharmaceutical industry funding of research and publications
- High US drug prices and profits compared to other countries
- Lack of accountability and consequences for harms caused by pharma products and policies
- COVID-19 vaccines lack long-term safety data and adequate effectiveness evaluations
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