How Are New Medications Developed?


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