Growing up, Calpol was just about the tastiest spoonful of anything you could have when your fever spiked as a child. No? Okay. I gather there are sugar-free options lately, the banes of living in the 21st century. We substitute good old sugarcane pulp with synthetic flavor enhancers and term ourselves emancipated.
We pop painkillers, purchase that prescription drug the doctor scribbled for you, get vaccinated and carry on with life without giving a thought into how and why they landed in the market. Drug development is an expensive and intricate process that spans 12-15 years. For purposes of clarity, the word drug here refers to a legal substance for medicinal use, not recreational.
If you see me reaching out for a pill of any form, I am in dire pain and if you are a colleague, practice kindness by taking over my roles for the day. So I am clearly not one of the people fueling Big Pharma’s multi billion industry, an industry that elicits admiration and disdain in equal measure with reference to their work and intentions. However, the work they perform is still crucial because human beings are never short of health afflictions. It is an inescapable aspect of humanity.
By studying a particular disease, scientists understand its effects on the body and can hence design or refine an existing drug. This is called the discovery process. At this stage there are thousands of possible molecular compounds being evaluated and this has been made easier by improved technology; I see biomedical engineers nodding here.
These compounds undergo testing after which only a handful of them proceed for further testing. Think of it as a shortlisting for the right medicine and it’s all done to ensure the drug is effective and safe. ‘No side effects’ does not exist when it comes to drugs hence they find out the minimum dosage required for maximum efficiency and minimum side effects. Other important factors would include mode of delivery-whether oral or injectable, how it affects different groups of people based on race or gender, how it interacts with other drugs and of course if it is more efficient than an existing drug serving the same purpose. You can see how laborious it already is.
This is followed by pre-clinical studies that involve both in vitro (in test tubes) and in vivo (in a living organism, mostly animal testing) tests. The results of this determine whether the selected compound(s) will be tested out in human beings. The number of compounds will have narrowed down to be about 5 and 3-4 years would have lapsed from the start of the process.
Because what happens in the lab could induce a completely different response in the human body, clinical trials have to be conducted. Clinical studies, which could very well run into the 9 year mark occur in 3 progressive phases and people voluntarily enroll into them. Different criteria for enrollment are employed depending on the drug and nature of disease being studied with two main goals: efficacy and safety. Part of the work force here includes clinical trial coordinators, medical doctors, microbiologists, pharmacokinetists and toxicologists. Clinical trials have to be authorized by regulatory bodies; enter FDA in the USA and EMA in Europe.
Millions of dollars and about 12 years later, 9 out of 10 drugs will fail at clinical trial level.
However sometimes lady luck is in a generous mood and a drug is repurposed out of a failed clinical trial. Famous example being Viagra- sildenafil citrate, it started out as a drug on trial in a Pfizer lab to relax the hearts’ blood vessels in angina (heart condition) patients. The drug failed in subsequent clinical trials but the volunteers reported increased number of erections and in 1998 erectile dysfunction found a cure from the little blue pill. Now, Pfizer is to the pharmaceutical world, what Apple is to the tech world, it’s big, it’s powerful and controls a large chunk of the drug market.
If a drug succeeds at clinical trial, they can then apply to the same regulatory boards for authorization to market the drug. This is only granted if the drug, one compound from the thousands, meets all required standards. This process can take 1-2 years.
Post market surveillance is done even after approval of the drug into the market. These people have your best interests at heart. Marketing job at Pfizer, anyone?! If you feel a drug affected you in ways it shouldn’t have, you can always report it using avenues such as Medwatch.
In Kenya, Pharmacy and Poison Boards is charged with approvals for both locally manufactured and imported drugs. If like me, you choose to hang your white coat, you can still work as a regulatory officer either directly in pharmaceutical companies or pharma consultancy firms. I am busy laying out the options for you.
If you are the brains behind a drug, it is patented under your name or let’s just say under the pharmaceutical company’s name. Patents, being the intellectual property rights, are a main revenue source for pharmaceuticals. However they are time bound and do expire. After which any other company can produce the same drug with a different name and sell at a cheaper price, birthing, generic drugs. Do Tylenol, Crocin, Dolorol, and Mildon ring a bell…they are all paracetamol generics, similar function to Calpol.
There are patent attorneys particularly for the field of life sciences who ensure this system isn’t infringed. You do not need a law degree for this. If you gave up on your lawyer dreams at some point, in this particular case, you get to have your cake and eat it. Most of the firms currently specializing in this service actually pay for your professional attorney exams. Hey, let’s be practical, you don’t need to go through the painful process of law school but you do need a bit of training in the legal business.
You can now go back to using your medicine as prescribed with a bit more appreciation of the work that goes into it. Attempt to read the insets one of these days…It makes for a good pass time activity while in traffic.