Where money is going...

There are different ways of calculation how much does cost a development of a new pharmaceutical product but it is obvious that the efficiency of drug development is gradually decreased and it takes more and more resources for launching of novel drugs.

Let's analyze where these resources are being pumped. Let's take a look on the typical development process:

Here we have huge holes where money is disappearing:

1.    Cellular and genetic targets – in order to start the development the targets have to be specified. Well, I can argue that there are a lot of efficient drugs out there with unknown mechanism of action, so this step can be successfully omitted.

2.    Genomics – very huge hole. The idea “gene – protein – drug” or “key-and-lock” is extremely simplified, mechanistic and not scientific anymore.

3.    Proteomics – the same situation as for genomics.

4.    Bioinformatics – I think that this discipline was invented exclusively in order to find out any possible application of enormous bunch of the data from genomics, proteomics etc.

5.    Now we came to synthesis and isolation – very classical step in drug development process. But wait a minute – it is not the same synthesis anymore, it is not enough to synthesize and isolate a putative drug candidate – it is too simple! In modern epoch everything has to be automated and scaled up, therefore huge libraries of hundreds or thousands of compounds are produced by approach known as “combinatorial chemistry”.

6.    Combinatorial chemistry – a perfect tool to consume huge amount of money and time. And it gives rise of huge amount of crude compounds which are tested then on different types of assays.

7.    Assay development – well, it sounds scientific – and this process, guess what? - need also certain amount of resources!

8.    HTS – this is the crown of the whole concept – it is very often fully automated process which is always presented in action to the attention of investors during their visits to the drug development companies (I have this experience! This technique is really amazing)

9.    Library development we have already discussed in §6.

10.  Structure-activity-studies (also known as SAR) – this is completely alchemical or star-counting process which is beyond any rational understanding. Here basically can be spent any possible amount of resources: $1M or $100M – only fantasy matters!

11.  In silico screening – well, there are a lot of mathematicians out there, they need job and this field is specially invented to provide these job positions for mathematicians. Nobody cares and even understands the results of their calculations. There is no any rational how their numbers can be used in drug development.

12.  And finally, we came to the classical chemical synthesis.

13.  Drug affinity and selectivity – but who said that drug has to work selectively on special target??? If it doesn’t work selectively on a special target but have a hundred of different targets, does this drug have any chance to be an efficient medicine? The current paradigm has to say “NO”!

14.  Cellular disease model – it is relevant only for the minority of diseases.

15.  Mechanism of action – so the drug is efficient if we understand the mechanism of its action? - It is bogus.

16.  It is very broad statement, let’s skip it.

17.  And finally we came to in vivo. Here according to my understanding starts the real and productive science!

 

Well, you see and understand now why the process of drug development is so expensive! It is necessary to pay all the way for points 1-11 to fit your product in the modern paradigm. Then it is possible to brag that the drug has special mechanism of action, it selectively targets a receptor X and deactivates mechanism Y etc etc. But it has nothing to do with the Evidence Based Medicine – the ontology of the drug action which probably our last safeguard.