23.3 Drug Advertising: Ways Clinical Trials are Manipulated with Michael Shuman, PharmD

Renegade Psych

Join myself and Dr. Michael Shuman, PharmD, BPCC, as we discuss the negative impact of Direct-To-Consumer-Advertising (DTCA) in the US Healthcare System. This is a recurring series where Dr. Shuman and I will talk about various examples of the negative impacts of DTCA in America over the last 40+ years. We're living and working in a system now that is rife with misinformation and poor-quality research, and we want to make everyone a little more aware of just how many examples exist in US healthcare history of poorly designed and carried out drug trials and direct manipulation of data, leading to tragedies like with Vioxx, and eventual recalls of drugs touted as 'state of the art' and a 'technological advance.' Hopefully, we can instill systematic change that will improve how we go about measuring the safety and efficacy profiles of each new drug.

In this 3rd episode, we talk about various ways clinical trials can be manipulated by those that design them, emphasizing the need for ACTUAL REGULATORY AGENCIES that do their job and remain independent of those they regulate. We need more peer review in the field of medicine; if a researcher can convince one of his competing researchers that his theory or his work is valid, it would lead to a lot more certainty that the medications that gain FDA approval are legitimately safe and effective. From ghostwriters to surrogate markers, using rating scales to show 'statistical significance' when clinical relevance is unproven, using enriched study designs and removing difficult data points/patients due to 'concurrent illnesses, inclusion/exclusion criteria that make the studied population nothing like the intended treatment population, not publishing negative trials, and major journal editors being paid by the pharmaceutical companies themselves, the problems are seemingly endless. We also discuss the potential pitfalls of AI being used as tool for propaganda, as well as the importance of journal clubs and for all of us reading these studies to be highly critical of them. Hope you enjoy. Michael will be a recurring guest for this series on DTCA for our listeners to enjoy over the next several months.

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