Drugs: From Discovery to Approval

This Year Hacker News 2
This Month Hacker News 2


by criley2   2017-08-19
>Why on earth would you NOT assume that institutionalized greed affects the results of medical science?

Because I studied medical science and research for many years, have family in the medical field, and write medical software for a living.

Or rather, I understand very clearly how greed and the capitalist motivation affects health care, as it's literally my life. But with a realistic understanding comes the end of emotional histrionics and petty exaggeration.

AKA: I'm basically informed on this subject, unlike most of the commenters here.

>Who is funding the science? What are their financial motives? Who conducts the research? What are their financial motives? Are incentives aligned to produce quality medical research with the patient's best interests in mind, or the bottom lines of medical companies (pharma, medtech, even hospitals, etc.)?

What is GLP?

What is GMP?

What is a NME?

How many NME's does the FDA approve per year?

>I'm shocked and surprised at your shock and surprise. I don't think your arguments are irrational. I simply think they are naïve.

I'm not shocked or surprised at your response, it's a classic case of Dunning Kruger where you are so ignorant regarding medical science, the intense science based regulation of the FDA, and the business of creating drugs, biologics, devices etc, that you are inherently incapable of evaluating your or mine competency here. If you think I am naive, that is a real testament to the depth of your ignorance on this subject.

Back in university, we used this book to teach people the absolute and most basic fundamentals of this industry https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/0...

If you'd like me to answer your questions honestly, I'd be more than happy to take some time to source and answer your question from the perspective of someone who has studied this subject academically and participates in it professionally. But the book linked will discuss I believe every one of your ethical concerns.

by criley2   2017-08-19
It's not farfetched in the least to have one entity approve the drugs based on roughly $1 billion dollars over 10 years[1] worth of research.

What's more farfetched to me is allowing private, profit-motivated corporations the unfettered ability to produce this expensive research.

Fortunately the all-but-oppressive regulation of the FDA from GLP and GMP to insanely rigorous science-based four phase system of testing is IMO the greatest achievement in science-based regulation in human history.

People simple do not understand or respect the awesome power of the scientific method being the basis of government regulation.

[1] https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/0... and use the "look inside" feature to see page 4: "It is estimated that, on average, a drug takes 10-12 years from initial research to reach the commercialization stage. The cost of this process is estimated to be over $1 billion USD" (2005)

Another fun tidbit you'll find in the book: On average, for every 10,000 NME's that begin research, 1 NME will receive FDA approval. (where NME is a new molecular entity, a novel new drug).

So you've got a market where you have to begin development on 10,000 products to get 1 product into the market, on a 10 year runway. Could you imagine that in tech? 9,999 pivots per product!