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