Why is the discovery of new medicines so slow?

The world is changing faster than ever. Nanotechnology, 3-D printing, BioPen, robotics, and tissue regeneration will revolutionize the world soon. Science and technology are emerging in such a way that we will see the underwater cities and apartment buildings in space very soon. The cost per watt of solar energy will be less than oil and coal in near future. There is a weird way how science evolves, when Hitler was waging World War II every attention was diverted to it but at the same time some scientists were monomaniacally focused to humanity, as a result we have antibiotics and vitamins now. Could you imagine a drug which can safely eliminate the need for sleep or food? or what about a drug that makes you younger?

Relatively speaking, the discovery of new drugs to cure disease is very slow process. Why is the discovery of drug takes so long in reality? I am trying to give some insights so that people will have sense of complexity how painstaking the drug discovery process is. We always compare the growth and advancement of information technology with the slow progress of drug development. I am a fan of Peter Thiel, entrepreneur and author, and burrowing his words “we created computers ourselves and designed them to reliably obey our commands, but biotechnology is difficult because we didn’t design our body”. The discovery of medicine is very difficult process because our body’s complexity is designed by nature. We have to find out and study many small pieces of complex body and its alignment with synthesized drugs. The rise of digital health is encouraging because giant companies like Google, Apple and Samsung are showing immense interest in the drug discovery and life science industry. The one drawback we have found now is many pharmaceutical companies are focused more on patent protection of existing drugs than on the invention of new drugs.

At present, the R& D process in finding a drug takes around 13 years from the initial idea to commercialization. Drug discovery begins with product concept and ends with consumers in market. Initially, research target and synthesis of active substance (possible drug) takes about 1-2 years. These synthesized compounds are taken for pharmacological and biochemical screening before preclinical trial. The first phase of preclinical trial is for toxicity and stability of active substances. The second stage of preclinical trial devotes to pharmacokinetics, sub chronic toxicity, reproduction toxicological study and mutagenicity tests. After preclinical study, these active substances, potential drug candidates, should be non-toxic, no effects in genes, no cause in cancer or birth defects through animal study. After 1 to 2 years of research and synthesis, the complete preclinical study might take up to 2 to 4 years. After preclinical trial, clinical trial consists of three phases: phase I, Phase II and phase III. Phase I includes tolerability and pharmacokinetic study in human and also compatibility study when extended from animal to human. Phase II includes efficacy, toxicity and carcinogenicity study in human. Phase III consist of therapeutic large-scale trial, efficacy and safety proof, therapeutic advantage and study of interaction with other medications. After preclinical trial, the complete process of clinical trial may take up to 6 to 7 years depending on the situation. The interesting fact is that approximately 90 percent substances fail the clinical trial after passing animal studies, there are huge number of substances whose effects on the human body are unknown. The final part would be commercialization that includes registration with health authorities to launch and sales.  After the clinical trial, the total process of commercialization up to sales may take 2 to 4 years. In reality, one active compound out of 10,000 synthesized has a chance to become a real market drug after approximately 13 years of investment.

This is timing factor, if we consider money, it costs around $1-4 billion per drug for the major pharmaceutical companies. The more integrated approach and connection among basic research, screening stage and clinical trials will help to speed up the drug discovery process. Recent discovery of new tool like surrogate organs as a realistic, cost-effective testing of various chemical compounds could also reduce the cost and drug discovery time period.

– Yam Timsina