Contrary to widespread belief, generic drugs are not always identical to brand-name versions. Experts estimate a 13% failure rate, meaning they may lack potency, contain contaminants like arsenic, or have faulty delivery mechanisms, posing significant safety risks.
Facing public outrage, Mylan offered a "generic" EpiPen at half price. However, due to convoluted drug pricing economics, this move quelled the controversy while allowing the company to earn nearly the same amount of profit per device. It exposed the illusion of consumer savings in a broken system.
Despite sound science, many recent drug launches are failing. The root cause is not the data but an underinvestment in market conditioning. Cautious investors and tighter budgets mean companies are starting their educational and scientific storytelling efforts too late, failing to prepare the market adequately.
The issue with mass-marketed compounded drugs like Wegovy extends beyond IP infringement. It attacks the fundamental "social contract" of biopharma: companies invest billions in R&D for a period of market exclusivity. Allowing compounded copies to bypass this system erodes the incentive for all future drug development.
Pre-approval clinical trials, run by drug makers, reported a sub-2% discontinuation rate due to side effects. Post-market observational data reveals a starkly different reality: approximately 10% of patients stop taking statins due to adverse effects like muscle pain.
The public's deep mistrust of the pharmaceutical industry isn't baseless; it's rooted in the 1990s cultural shift toward a shareholder-first, 'greed is good' philosophy. This era led to questionable practices that created lasting cracks in public trust that the industry must still actively work to repair.
Mark Cuban reveals the primary barrier to making generic drugs in the US isn't production cost, which can be cheaper than overseas, but the prohibitive FDA application fees costing hundreds of thousands per drug.
Successful drug launches require nailing three fundamentals. Common failures include: misjudging the patient population (epidemiology), failing to secure reimbursement and patient access, and lacking clear differentiation against the established "gold standard" treatment in physicians' minds.
The process of testing drugs in humans—clinical development—is a massive, under-studied bottleneck, accounting for 70% of drug development costs. Despite its importance, there is surprisingly little public knowledge, academic research, or even basic documentation on how to improve this crucial stage.
A primary driver of recent pharma launch failures is underinvestment in pre-launch market conditioning. Cautious investors and tighter budgets mean companies have fewer resources to tell their scientific story effectively before launch. This delayed and underfunded approach has a dramatic negative impact on commercial success.
MedShadow's reporting reveals the manufacturer on a drug bottle is often a parent company, obscuring a complex supply chain of actual plants in countries like China or India. This lack of transparency makes tracking drug safety and quality nearly impossible for consumers.