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For-profit companies actually fund more R&D than public research does (globally the biopharma industry spends $200B+ on R&D a year; NIH budget is $34B; not sure
by aaavl2821 8y ago
For-profit companies actually fund more R&D than public research does (globally the biopharma industry spends $200B+ on R&D a year; NIH budget is $34B; not sure about other countries' public medical research budgets but doubt international public drug R&D approaches $200B tho i could be wrong).
Typically the way it works today is that an academic group, startup or big pharma company will have a "seed" of an idea for a drug. Some of the early drug discovery work happens in academia, some in startups, some at big pharma. But by the time that a potential drug enters preclinical development it is almost always owned by a for-profit company because they have the budget and resources for this work. At this stage fewer than 0.01%-5% of candidate drugs end up working and getting approved by FDA, and it costs tens or hundreds of millions to get a drug approved (and it can cost multiples of that if you include cost of failed drugs). So these companies take a tremendous amount of risk.
These days startups do most of the late stage discovery / early stage development work. They often take the drugs through the riskiest phases of development, generally up to Phase 1/2 or Phase 2 where effectiveness is first tested in humans. Phase 2 failure is the single largest driver of the cost of drug development. Phase 2 failure rates are as high as 60-70%, and it can cost $100M+ to get a drug to Phase 2.
In many cases a startup will try to sell their drug to big pharma after good Phase 2 data. At this point the risk is much lower (drugs have a better than 50% chance of getting approved), but they require significant funding to do the large Phase 3 studies needed for approval and to fund commercialization (can need 9 figures just for Phase 3 work and submission to FDA). So at this point it is a lower risk / lower return bet, but an expensive one, and big pharma companies are structured to take those bets.
However big pharma companies also spend a lot on early stage R&D. From looking at SEC filings, it seems roughly half of big pharma R&D is early stage and half late stage. The problem is that big pharma typically does not do well at early R&D. The return on investment in R&D at big pharma companies is approaching 0%.
Much of the high price of drugs is simply a function of the high risk and high cost of drug development. Very few drugs that pharma invests in actually become profitable drugs. So they try to milk all they can out of the few winners. It isn't the case that pharma's business model is buying fully derisked products from academia and then jacking up the price.
And while at some point publicly funded research could replace for-profit research, the reality today is that if we didnt have for-profit drug research then we would not have new drugs.
in 2017 the FDA approved 49 new drugs. None of those were owned by non-profits at approval (one was owned by a public-private JV). There is not enough non-profit money to take drugs through the development process to FDA approval
And when high prices do exist, in many cases it is because the drugs literally save lives. If you value a QALY at $50K / year (a common estimate), and your drug enables a child to live a full life who otherwise would have died at age 2 due to a rare genetic disease, it doesn't seem absolutely crazy to charge $1M for that drug. The issue to me seems to be more 1) what happens if you pay $1M for a drug and it doesn't work or 2) what if the patient cannot afford to pay $1M upfront for the drug even if it is guaranteed to add 20 healthy years to your life.
- cwkoss 8y agoThanks for the informative insight. > if we didnt have for-profit drug research then we would not have new drugs. I don't think that follows. If we didn't have for-profit drug research, we would have less volume of safety and efficacy testing and data on drugs, but we would still 'have' the drugs. I think drug testing reform must be part of the solution. Bringing a drug to market is too expensive.
- aaavl2821 8y agoA more fully accurate version of my statement would be we wouldn't have "FDA approved" drugs, but I dont think it's accurate to say we would still have the drugs without for profit research. Many (most?) approved drugs are discovered and developed entirely within for-profit institutions. And much of the technology licensed from academia are just assays (not chemical matter) which are used by pharma companies to screen libraries of drug-like molecules, which they must then optimize before they can be "drugs". Sometimes companies license drug like compounds straight from academia but it is rare that these compounds are fully optimized for human use -- sometimes they are very rudimentary and wouldn't be suitable for human use without significant optimization -- and they aren't really yet "drugs" Pharma companies don't just run clinical studies. They do a massive amount of discovery work and preclinical development, probably on the order of $100B worth / year I do agree that drug testing reform can play an important role in lowering the cost of drug development. Things like not requiring cardiovascular outcomes studies for diabetes meds would be a great start, and providing clearer guidance for development of complex generics. However i dont know what else might be done that wouldnt compromise the quality of approved drugs, a lot of the difficulty is just our limited ability to directly study human biology