The key to taking a drug through trial is having enough cash for the trial and for your company to survive the time it takes to complete the trial successfully. Remember that said success is not guaranteed and you might have to write off years of work and start from scratch.
Drugs in the west are also expensive because successful drug companies pay their employees a lot of money (a cost that affects profit) but are still extremely profitable (by carefully figuring out what each regional market can afford to pay to maximize their revenues). These companies know that westerners will spend significant fractions of their income for medicine.
(I also agree that having large amounts of cash and runway is necessary for a successful trial).
And to add, a clinical trial can be thought of as just one step to establish evidence for efficacy and safety.
Because if you really want to prove that it works and is safe, you have to give it to a lot of people, all of whom have different health conditions. To establish that, you would ideally give it to everyone with the disease of interest. But you can't test a drug on the entire world, so.... you only find so much in a clinical trial.
It's known that about 90% of new drug candidates fail somewhere along the clinical trial process. While a successful drug by itself might cost a few 100 millions of dollars, the failures means that the amortized cost is about $1 billion.
This is why compounds change hands so many times before they are successfully commercialized. Running a phase three study costs much more than a phase two. Pharmaceutical companies partner to pool the risk and share the cost.
Subverted... In opposition to the IT startup scene, you mean?
Right now, the cost of R&D in the drug market is such that even companies worth billions recede before the task. The classic argument regarding that is too much vs. too little regulation. Unfortunately, no one can decide the truly necessary amount of consumer protection, so you end up with a balance between no innovation vs. Thalidomide.
It is more than there currently is, that is for sure. Statins, fluoroquinolones, h2 receptor antagonists. These drugs all given out to millions of people and all have terrible problems to the point that now quinolones are last resort, and acid blockers Recalled, even though theyve been prescribed for years. Way too much collateral damage.
So many really bad drugs that are popularized and thrown with black-box warnings and such after the fact.
I think the integrity of that system has been subverted.