CORONAVIRUS PANDEMIC AND NEW DRUGS DISCOVERY

WHY ARE NEW DRUGS SO RARE AND SO EXPENSIVE?

 “It is an art of no little importance to administer medicine properly.”  -Philippe Pinel

Now that the whole world is facing the devastating Coronavirus pandemic, it is impossible not to think about Coronavirus treatments with currently available medications.

There is some anecdotal evidence in medical literature that two old anti-malaria medications chloroquine (CQ) and hydroxy CQ have some antiviral activities. Clinical investigators are looking at them more closely in viral/ cell cultures. In the meantime they should not be promoted, as has been done by some politicians and prescribed by some practitioners. These medications are not specifically designed anti-viral medications. They are not simple medications and are very toxic for the heart.

Discovery of new drugs, especially anti- viral new drugs are extremely difficult, expensive and time consuming. At the present time, a promising anti-viral drug called remdesivir is in clinical trials. We are all hoping for its success.

An encouraging, recent clinical study from Germany revealed 5 critically ill patients, with severe coronavirus infection and respiratory failure, completely recovered after receiving convalescent plasma with a very high titer of neutralizing antibodies, obtained from patients who recovered from the same illness within a week. (Chen C et al JAMA, March 27). This small study tells me that a vaccine against coronavirus is going to be very effective. 

Anti-viral drugs, unlike antibiotics, don’t kill their target pathogens, they just inhibit some vital viral enzymes or proteins to cease the replication of the virus. The virus enters the cell wall and replicates inside the cell and makes special proteins to keep the immune system at bay.

In order to design a new anti-viral drug, after sequencing the viral genome, the virus’ biology has to be studied in cell cultures to determine important viral enzymes, functional and signal proteins so that they could be targeted with non-toxic chemical compounds. This is a very complex, very difficult and expensive task that may require many years of demanding studies.

We tend to accuse the pharmaceutical companies (big Pharma) of greed and profiteering for very high new drug prices. Before we blame them, let’s look at the difficulties and expenses they face.

Drugs are foreign substances (xenobiotics) for our body. Our body does not treat drugs like food substances. Any drugs that we take, whether by mouth or by injection, is absorbed and sent directly to the liver. The liver is the body’s great chemistry laboratory. It has many sets of different mechanisms and enzymes (specially cytochrome P 450) that can break down and  modify the chemical structure of the drug to prevent its harmful and toxic effects. The liver also converts drugs into water soluble or fat soluble substances so that that they can be excreted via the kidneys or bile, so that a dangerous drug accumulation in the body does not occur. This is why experimental drugs have to be tried on laboratory animals to see if any liver toxicity or damages occur. Only then could they be tried in human clinical trials in three separate stages.

Usually 9 out of 10 experimental drugs fail the clinical trial stage. Studies have shown that it takes 10 to 12 years to bring a new drug from laboratory to the market, and it costs about $2 billion dollars.

Global pharmaceutical companies industries invest $80 billion dollars yearly for research and development of new drugs.

The era of conventional “hit and miss” experimental drug development is over. Many scientists think that advances in AI (artificial intelligence) and deep machine learning will help the discovery of new drugs to be easier, faster and less expensive.

Only the future will tell us if it is so. In the meantime, our best chance against the Coronavirus infection is self-isolation, social distancing and wearing PPE (personal protective equipment) when going out for necessary needs.

I have a bad feeling that economic catastrophes following the Coronavirus pandemic will be evenmore devastating.  May God help us all.