Table of Contents
Keith Altman was one of the speakers in a seminar discussing the pharma industry and how medicine, business and law are interconnected in this industry. He offered insights into a world where data interpretation is crucial, and the consequences of overlooking minute details can be severe.
Below is a list of his insights discussed in the seminar…
Who is Keith Altman?
Keith Altman is a unique voice in the world of pharmaceuticals and law, thanks to his distinctive blend of expertise in both statistics and law. This dual knowledge base equips him to approach drug-related challenges with a refined perspective, bridging data interpretation and legal implications.
Decoding the Zoloft Defense
The 'Zoloft defense' is a notable subject in both legal and pharma industry. Altman unpacked its history and usage, addressing the legal and scientific challenges it presents.
The Multi-faceted Role of Data in Legal Cases
Altman emphasized the importance of viewing data from various perspectives. He drew an intriguing analogy to tracking dinosaurs in a park, where overlooking details can be crucial. The presence of inherent biases may skew data interpretation, therefore it’s necessary to have unbiased, skilled analysts.
Simplify FDA Adverse Event Data
The seminar highlighted the nature of adverse events and the process of reporting them, revealing the huge volume of adverse event reports and its implications. Moreover, Altman discussed the limitations of clinical trials indetecting uncommon adverse events, emphasizing the crucial role of post-marketing safety surveillance in this context.
The Topamax and Neurontin Controversy
The seminar explored the gap between anticipated and real sales figures for the drugs Topamax and Neurontin which have been surrounded by legal controversies. Altman highlighted the legal ramifications and the considerable fines tied to their promotion.
Inside the Adverse Event Reporting System
A significant portion of the discussion revolved around the sources of most reports and the substantial impact of drug labeling on reporting requirements. Altman also highlighted the significant underreporting by physicians, which complicates the thorough evaluation of drug safety.
Interpreting Adverse Event Data Accurately
The seminar highlighted the risks associated with treating raw numbers as definitive evidence. Altman emphasized the importance of identifying patterns and critically assessing the kinds of adverse events in connection with anticipated side effects of the drugs.
Legal Complexities: Learned Intermediary Defense & Patient Package Inserts
Altman tackled the challenges of the learned intermediary defense, while also examining the crucial role of patient package inserts in shaping decisions related to patient safety.
Exploring the Nuances of the Involuntary Intoxication Defense
The seminar discussed the linkage between this defense and adverse event data, explored its ramifications in the realm of civil litigation.
Humor & Seriousness: Striking a Balance
Despite the serious nature of the seminar's topics, Altman touched on the delicate balance between injecting humor and addressing critical issues, highlighting the human element in such debates.
The Pharma Industry Companies' Role in Courtrooms
A significant portion of the discussion revolved around the involvement of pharmaceutical giants like Pfizer, aiding prosecutions and the ethical concerns surrounding such companies funding expert witnesses.
Broader Perspective on Drug Safety & Responsibility
Altman advised attendees to see the bigger picture instead of concentrating solely on individual data points. He encouraged a comprehensive approach, wherein both doctors and patients share the responsibility of understanding and addressing potential drug side effects.
The Risks of Bias and Misrepresentation
Altman highlighted the possibility of companies manipulating data, emphasizing the collective responsibility of both the FDA and pharma industry firms to guarantee accurate reporting.
The FDA's Role and Limitations
Altman offered a critique of the FDA's methodologies for signal detection, highlighting potential flaws, especially concerning new drugs.
Real-World Case Examples and Expert Testimonies
In the end, Altman discussed actual cases and shed light on both the value and potential drawbacks of expert testimonies within courtroom environments.
In conclusion, Keith Altman's seminar provided a deep dive into the interconnected domains of pharmaceuticals, law, and data interpretation. His valuable insights offer a guiding light through these complexities, emphasizing the need for diligence, accuracy, and ethical responsibility.
Dr. Timothy Markley, Ed.D., is the Director of Student Defense at KAL and an accomplished author. He has written notable articles, including "Passing a School Bond in the Era of Social Media: District Administration" (April 2015). Tim is highly regarded as a speaker at state and national education conferences, including the Mecklenburg and New Hanover County School Justice Relationship Models.