There has been a lot of noise and confusion about potential cures and remedies for COVID-19. From our own much touted but yet undisclosed cure from the cradle of civilisation, to the internationally notorious Madagascar syrup, several people have asked that the public be allowed to “test” these remedies.
The reason why no regulatory body will approve the used of an untested drug which has not undergone rigorous clinical trial is because of the potential harm such a drug can cause. Even when complete clinical trials and double-blind tests are completed, and drugs approved, it can still be revoked as in the case of COX-2 inhibitors.
The COX2 inhibitor was supposed to be the “miracle drug”. It had all the advantages of a normal NSAID like Ibruprofen, without having the side effect of ulceration. Yet, it was found post approval that it caused increased numbers of heart attacks and strokes.
To better appreciate the drug discovery process, I will briefly explain each stage while adopting a humorous writing style to discuss this potentially mind-numbing subject.
When a substance is suspected to be a cure for a certain disease, “bench research” or lab research is carried out. This is the Research &Development phase in a lab with cells in a dish. It is painstaking work.
When I was awarded the MEXT Scholarship to study stem cells in Japan, this is what I was doing. Walking from Tokyo Eki to Shimbashi everyday (since I did not have transport fare), resuming at the lab, putting on my white coat, drinking green tea, performing experiments on cells, recording my findings, presenting my findings & hoping that we would receive approval to move to pre-clinical phase.
Getting approval means you need evidence at the bench stage that this cure worked in your petri dish. This requires a lot of paper work, late nights, presentations at international conferences, weight loss and nerves. Most don’t get approval.
When you get to the pre-clinical stage, you are in the game. Then you get to test your cure first on small mammals like mice, then on larger animals.
These animals cannot get sick, and they need to be constantly monitored. If a single thing goes wrong with any animal, whether it is your drug that caused it or not, these committees do not care. They are looking for issues/problems/inaccuracies/inconsistencies and they are meticulous! Any tiny problem and that will be the end of your research, your funding will be cut and you are back to square one.
One of the words used in the lab a lot was “mendokusai”. In Nigerian slang it would translate to “long thing”.
Research is bothersome; absolute attention to detail is mandatory. And it is thankless. After the bench research that lasts years, the pre-clinical trials (during which NONE of those mice can die; nothing can happen to them), then approval is sought to move to the clinical trial stage. The chances of this are literally one in a million.
This stage also has its own set of issues and challenges. You have to design and execute a randomised, multi-centre, double blind controlled trial. This means that the drug must be tested on a lot of randomly selected volunteers, in different centres or cities and measure its effectiveness against a fake drug “placebo”.
The nurses that are giving the drug CANNOT know which drug is real and which is placebo to prevent bias. The patient cannot know if they are getting the real drug or placebo. That is double blind.
At this stage, you are paying for the hotel, you are paying for the drug, you have not made one kobo yet. You are paying the statistician. Don’t forget all those mice you paid for in the lab a few years ago.
At this stage, you may be several hundred million dollars in. And unlike Davido, there is no assurance and you don’t have 30 billion in the account. You have 30 billion potentially down the drain.
There are all sorts of random reasons that your clinical trial may fail because it will be reviewed by other smart researchers whose aim is to tear your methods apart. You have to be super careful.
If the drug successfully scales this stage, then it is presented for approval. You need a team of like 50 people who has been working at this for months to put all the documents together. This is the FDA and they do not play. They are paid to see problems in all you have done so far.
Many drugs go through this whole process and don’t get FDA approval. The FDA does not care about the billions that have been spent, your dreams, your family members that you took money from, or your investors.
They are focused on safety. If the documents provided do not satisfy them, they will not approve the drug. And they won’t feel any remorse.
There is no shortcut. They cannot be bribed. They cannot be hoodwinked. They cannot be blindsided (not usually). This is one of America’s ‘strong institutions’. After FDA approval you can start marketing your drug.
But then comes the yellow card system.
All adverse drug reactions across the world need to be reported via this yellow card system to ascertain that if there are any problems in the wider population.
Guess what? AFTER ALL THAT SUFFERING, the drug can be withdrawn if a side effect that didn’t show up in clinical trials shows up in the wider population. This happened quite famously with COX-2 inhibitors earlier referenced.
Side effects like heart attacks and strokes did not show up well in the clinical trials. Therefore, most of them had to be taken off the market. Patients that had been in pain for years were finally pain free. They were going to church to testify about this drug because IT WORKED.
It killed pain, but unfortunately with the side effect of killing people as well.
The biggest scam is when people think that because something is ‘natural’ it has no side effects or cannot kill. Poisonous mushrooms are quite natural, and can kill rapidly too.
While the drug discovery process is being relaxed in the case of COVID-19, there still has to be a process beyond mixing something in your kitchen, announcing it to the press as a cure then asking influencers to trend it.
It’s not Brazilian hair.
Things to look for in any information claiming to be the new #COVID19 research/cure
- CT/MRI/XR results so everyone can see? Blood tests?
- Proper case series
- Appropriate number of patients
- Reported in a Tier 1 journal
- Peer reviewed
- Double blind clinical trial
- Randomised clinical trial
- Multi-centre clinical trial
Ola Brown is a British-Nigerian medical doctor and Managing director of Flying Doctors Nigeria; a charity based in Lagos, Nigeria