This is a great insightful overview of the misguided incentives in drug development. Post research and approval, there are also ethical problems in the way the expansion of drug use through marketing impacts people with multiple and chronic health conditions and disabilities. These problems extend to all evidence-based treatment approaches and can't be "fixed" by lawsuits or new rules....
There are numerous ethical concerns regarding the licensing and prescription of pharmaceuticals. I was aware of many of them before I began my career in research. However, some things can only be truly learned through experience.
The crux of trials 101:- It is neither cost-effective nor practically feasible to conduct life long studies of drug usage in chronic conditions. For obvious reasons, it would be very difficult to find a stable cohort of patients who would wish to participate in research indefinitely, especially alongside dealing with a difficult medical complaint.
Trial methodology is designed to test a hypothesis, aligning patient eligibility criteria, protocol procedures and primary/secondary data endpoints, to best demonstrate desirable, marketable treatment outcomes. All while hopefully keeping side effect collateral to a minimum.
The emphasis falls therefore, on short-term tolerance i.e. pharmacodynamics and pharmacokinetics. Simplified, this is how the drug reacts in the body and how the body reacts to a drug, respectively. In pragmatic terms, this involves assessing a given bunch of data points such as, absorption, distribution, metabolism and excretion. Under these umbrellas, there are a number of vital specifics, such as dose ranging and half-life i.e. time taken for the drug to metabolically reach 50% of the original dosage concentration. Then of course there’s efficacy and side effects, or adverse events.
This is not an exhaustive list, but a means to address the point that such check boxes, fit neatly within a given study phase and specific assessment parameters.
Clinical trials rarely and can’t really, last long enough to reflect prolonged pharmaceutical usage outcomes. Since medicine and science is ever-evolving, there is always a new competitor star product emerging to take the spotlight, and steal away big pharma priority where funding and resource allocation is concerned.
My first job in academic research consisted of a blur of over worked under paid research fellows, all scrabbling over each other to get noticed by some Professor or other. They were ruthless in their work ethic, hungry for names on publications and very reluctant to offer each other even the smallest amount of help. I witnessed firsthand, medics who would fake favourable study outcomes to guarantee their sought after recognition and subsequent PhD. The worrying thing is, when such a study reached the pages of a well known medical journal, it actually influenced international treatment recommendations. After all, research facilities in hospitals are central to the development of evidence-based medicine.
I can’t say categorically if said tampered outcomes would’ve proved harmful to anyone, but it was certainly a deviation from the patient’s standard methods of treatment, and was supposedly a preventative recommendation. How can one later prove whether therapeutic intervention to stop something from happening, was the only influence in an unchanged medical baseline?