Problem with current Drug Development process and methodology

Currently, everyone (every pharmaceutical company) follows the standard drug development process (methodology) as referred by FDA:

The Drug Development Process | FDA

drugs are developed according following 4 steps:

  • Early Drug Discovery,
  • Pre-Clinical Phase,
  • Clinical Phases I, II, III
  • Regulatory Approval.

Let’s break down to more detailed steps:

  1. Research how the disease is developed and progressed;
  2. Identify which part of the progress can be used as a “target” to block certain reaction (to not let it become worse);
  3. Validation, Screening, Assay Development, Lead Optimization, and In vivo and In vitro ​Assays;
  4. Then in pre-clinical phase, animal test, to provide sufficient evidence of safety and efficacy before Clinical Trials in humans can begin
  5. Clinical phase I, II, III
  6. Phase II: test on 100 to 500 adults, to examine the effectiveness, tolerability and dosage, the therapy concept is primarily checked(proof of concept)
  7. Phase III: test the drug on thousands of patients to see whether the effectiveness and safety can be confirmed in many different patients
  8. Approval from FDA
  9. Post-Market Monitoring, or called Phase IV studies (also known as Post-Marketing Surveillance Trials): More comprehensive data can be gathered regarding the effectiveness and safety of the new drug. These studies are designed to assess the long-term effects of a drug

Did you feel something wrong with such process and methodology?

Body is complicated, and all parts are interacted. We still don’t understand how it functions very well.

Within limited knowledge for our body’s complicity, this would be the best methodology in Science’s system to find solution for disease so far. And it looks so scientific.

However, when we look back for such standard process/methodology for new drug development, we need to understand there are some assumptions behind it, and some time it may not be right. Here, we’d like to challenge this process/methodology.

  1. It ASSUMES the animal is same as human body. The fact is: it is different. No matter how closely an animal model to mimic the human being, it’s not human being. It’s totally different.

Safe in animal doesn’t mean safe in human body (So need to continue clinical trial); While harmful to animal doesn’t mean harmful for human body we may miss something here).

Efficacy in animal model doesn’t mean efficacy in human body (so need to conduct Clinical Trial II, III); While non-efficacy in animal model doesn’t mean non-efficacy in human body (we may miss something here).


  1. In all Clinical trials, all the results are based on statistics. Remember: Statistics is NOT an exact science. Check article here:

Journal of the Royal Statistical Society. Series A (General) Vol. 141, No. 3 (1978), page. 385. (link:  Is Statistics a Science? on JSTOR)


“A distinction is drawn between science and technology. The former has been studied by Karl Popper and his ideas are widely accepted; the latter has had less attention. The inter-relations of the two are considered and it is pointed out that neither can be said to underlie or dominate the other though practitioners of each are often intolerant of the alternative approach. Statistics may have a more important role to play in technology than in science; it may itself best be considered as a technology rather than as a science. These ideas are discussed in the context of the teaching and practice of statistics in general and medical statistics in particular.”

Nowadays, most scientists always conduct a survey or do some statistics, then draw conclusions from it. It’s not the exact science. Statistic results only provide a possible assumption or explanation and need to conduct more precise research to find solid proof before drawing a solid conclusion.


  1. Most important fault in the model is: does it fix the problem? NO WAY !

The drugs fund by this methodology has fundamental flaw. If something is used to “block” the target (e.g. to block the XXX Factor to bind the Receptor), what if when we stop taking such medication? The problem still exists !

So, you need to keep taking the medication to prevent situation become worse. WOW, that’s why pharmaceuticals love that. They hope you can take the drugs for ever.

If you keep taking the drugs, obviously, it would have more side-effects. Think about this: if you keep using drugs to “block” something, then, this “something” may accumulate. And one day, your body may not tolerate it again.

The question is: WHY can’t we fix the disease and make the body functional as normal as before?

The answer probably is mixed. First, we really don’t understand how everything in our body is functioning; second, if the disease is completely fixed, then the drug company’s profit will be gone. So, it seems like within a quite long time, we will continue such model to develop the drugs for people to take forever.  We’ll get into this question in another article with more detailed discussion later.

With such a fundamentally flawed drug development system, all the drugs developed are only for temporary solution, and only benefit the pharmaceutical company’s profit, instead of helping patients recover from diseases.

Probably we should learn something from the Alternative Medicine such as TCM, to conquer the disease, for real.



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