Ask HN: Why there are many inefficient drug trials
Hi HNers,

I would like to have your opinion on the following (controversial) text as I intend to blog about it on my website

www.padiracinnovation.org/News

Many thanks!

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Do you ever wonder why:
- There are still no efficacious drugs to stop disease progression in Alzheimer's, Parkinson's, or ALS diseases.
- Why does each disease seem each year to be divided into many new different diseases, each with a different drug target?
- Why there is a huge disconnection between academic research and pharmaceutical companies' research?
- Why do drug trials look to be stupid like testing five times the same drug for the same disease? (memantine for Alzheimer's disease)

The simple answer is strategic patenting. There are indeed more convoluted answers. Famous academics have written about this topic.

In a nutshell:
Two decades ago patents of many mass-market drugs expired while pharmaceutical companies had no new drugs with high margins in their pipeline. So pharmaceutical companies decided to shift their strategy to drugs targeting tiny markets with very high revenues. This is facilitated by social security mechanisms. But in doing so they are again cornered in a dead alley where they can't find efficacious drugs.

1. The research is NOT about finding which drug heals which specific disease, instead it is about researching WHICH disease is healed by a specific drug. See the high number of drugs repurposed to another disease following unsuccessful trials.

2. As the number of diseases is limited (for example there are only a few thousand diseases in WHO's ICD-11 and there are "only" 20,000 human proteins), to keep revenue each year new diseases must be introduced. Furthermore, research for a very narrow, specific condition is probably more easily planned than research for a drug for a spectrum of symptoms.

3. A powerful way (and seemingly rational) to split existing diseases into many new diseases is to condition diagnostic to molecular biomarkers. For example, this is ongoing for Alzheimer's disease, even if nobody is sure these biomarkers are really pertinent).

4. A company will never search for a non-patentable drug because it wants exclusivity to a market to keep skyrocketing prices. A possible alternative strategy is to couple a natural relatively efficacious drug with another drug and to target diseases where this second drug was never used in a patent description. An example is a recent ALS drug.

5. As drugs target very narrow conditions for tiny markets (less than 10,000 prescriptions per year), the financial turnover is meager, so the prices must be high and the barrier for competition must be high, hence patents.

6. As most of those new diseases are mostly artificial, these drugs are indeed mostly inefficient. The best example is Alzheimer's disease where there had been ~320 phase III clinical trials! At 20 Million for the phase III clinical trial, this is very inefficient!

7. The pharmaceutical industry won't use academic research as often (less and less) it is not patentable as the goal of academics is to publish as soon as possible and as their research, ideally, should be reproducible by peers. Hence the disconnection between academic research and industry. Anyway, academic research is not of the best quality. For example, academic literature suggests targeting mostly any biological molecule for a given disease and the modality is always to knock down it. This is very unlikely to work as biological pathways are very redundant and non-linear.