People take medicine every day, but not many people know how arduous of process that those
drugs have to go through to get from idea to your body.
Hey guys Julia here for DNews
The pharmaceutical industry is big business. According to a study published in the Annual
British Journal of Clinical Pharmacology world pharmaceutical sales are approximately 365.6
billion dollars. “Big Pharma” is often portrayed as the villain. Sometimes rightfully
so, think of a recent example of a company acquiring a life saving drug and jacking u
p the price 4,000 percent overnight. But it's not always about greed. One of the reasons
for the high price of drugs is simply it’s so expensive to develop a new one.
Developing a new drug or medicine is a slow and expensive road. It can take decades and
billions of dollars before a drug ever reaches the FDA -- who then has to approve it for
use. According to The Association of the British Pharmaceutical Industry for every successful
new drug about 25,000 chemical compounds were tested, on average 25 of these will have gone
into clinical trials and just five will receive approval for marketing. And according to a
report published by the Tufts Center for the Study of Drug Development (CSDD) it costs
more than $2.6 billion to make a drug that finally receives approval.
So why does it take so much time and money? Well the FDA, thankfully has established strict
guidelines for drug manufacturers as well as, quality control measures like good laboratory
practices and guidelines for clinical trials.
With that in mind, drug discovery often starts with basic research. Scientists might find
mechanisms behind cellular receptors, ion channels and enzymes. For example, research
in the 60s on neurotransmitters led researchers to discover an imbalance of brain chemicals
might have something to do with depression. Knowing that, drug companies could get to
work on a way to fix that imbalance. Shout out to basic research! Woo woo!
Historically medicines were discovered in nature, like bark from the willow tree which
ancient cultures used to relieve pain. Turns out, the bark contained a compound which modern
pharmaceutical companies used to make aspirin.
Your granddad’s pharmaceutical researcher had to create new compounds by hand,and could
only make about 50–100 new compounds every year. But today, using genetics and computer
models, researchers can quickly predict what compounds will work and create a bunch of
samples using specialized robots. According to a study published in The Pharmaceutical
Journal, as many as 10,000 compounds may be considered and whittled down to just 10 to
20.
From there, these compounds must be tested. Drugs must go through rigorous testing to
make sure they do what researchers suspect and that they don’t have overwhelmingly
negative side effects.
First compounds must go through either phenotypic screens or target-based screens. Phenotype
screening measures the test compound's ability to affect cells, tissues or whole organisms.
It's pretty general. Target screening measures the effect of compounds on a purified target
protein in a test tube, so it's way more specific. It's called an in-vitro assay, and it targets
the direct effect a molecule or compound has down the protein. Even with the best phenotype
screening, the target-screening is way more valuable to the scientists and regulators.
Only compounds which show positive activity are developed further. They are made in larger
quantities and subjected to more and more tests. Some compounds are tested in animals,
then they go on to clinical trials, which test the compounds in humans in tightly-controlled,
highly-regulated studies. Phase one trials test the safety of the new drugs, phase two
tests efficacy, and phase three are the holy grail of science: double-blind, placebo-controlled
studies.
After all of this, if the drug does what's it's supposed to do predictably, it can be
submitted to the FDA for market approval. So you imagine with all this time, effort,
money and a huge failure rate, pharmaceutical companies tend to focus on drugs they think
will have the best financial return.
Over on testtube news, I dig deeper into how exactly drug prices are decided here in the
United States.
Go any other questions about how stuff is made or about the scientific process? Let
us know and remember to use the hashtag ASKDNEWS