Well. They probably do not. Unless, you agree yourself.

At a point I worked in the pharmaceutical research.
While studying medicine and doing medical research, I knew some rough ideas about the drug development process. I knew something about 3 phases of the trials and so on.

However, I did not realize how complex the process actually is. There are actually 4 phases of just clinical trials, and several more before that.

So if you are interested how they test drugs on you, let's in brief discuss the process.

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Well. They probably do not. Unless, you agree yourself.

At a point I worked in the pharmaceutical research.
While studying medicine and doing medical research, I knew some rough ideas about the drug development process. I knew something about 3 phases of the trials and so on.

However, I did not realize how complex the process actually is. There are actually 4 phases of just clinical trials, and several more before that.

So if you are interested how they test drugs on you, let's in brief discuss the process.

If you read some fiction about how some poor boy from a dumpy inner city block accidentally discovers a blockbuster drug that immediately cures half of the world population and the boy becomes rich overnight, forget about that.

Fiction is fiction. Bad fiction.

Nowadays drug discovery is very complex, lengthy process.

To bring a drug to market in US now costs a billion dollars. And the price goes up non-stop.

Why is this so expensive?

Many things are involved. I will not go into all the details. Actually the research part is approximately quarter of overall cost.

However, you can see that rare and only really rich company can bring a new drug to the market.

The part where they use patients is named clinical trials.

You see, to develop the drug, you need not just a good, bright idea, and bingo - you are a winner. No. To get that drug into the pipe, you need to overcome a lot of obstacles.

This is why so many bright ideas die in droves on the way to the clinics.

There are several ways of drug development. One is when big research centers and universities may try to do the pre-clinical research and later clinical trials on their own. However, the mainstream way of getting the drug on the pharmacy shelves look like the following:

1. Laboratory and Animal Studies
2. Clinical trial in humans

The drug research is lengthy and expensive process

In the beginning of a single drug, researchers test thousands of different compounds. One of 1000 will make it into the second part of research – clinical trial. And only one out of 5-10 of those, tested in the hospitals, will give something worthy to talk about in the end.

The goal of the search is to find the stuff that treats you, but does not harm too much on its own.

On average around nine years is the time from the start of the tests to the production of approved drug.

Several Agencies internationally oversee the process of drug development in order to avoid the pitfalls of overzealous generation of ineffective drugs with multiple side effects.  In United States the process of drug approval is overseen by Food and Drug Administration.

How do the scientists discover new drugs?

In the past majority of drugs were found by mere lack or incidence after an inquisitive scientist or doctor saw some unusual, potentially beneficial effects of some substance; or the drugs were derived from plant (rarely from animal) sources known for ages for their medicinal properties.  So, you see, by the way, there is nothing wrong these days to use the same old herbs used for centuries.  Just the new drugs are usually much more potent and thoroughly tested.

These days, big companies have more sophisticated methods of the hunt for new drug candidates.
If you worked in a lab, as I did, you know how the lab research done – complicated thorough protocols, followed precisely, where the complicated answers are tried to be solved by complicated methods. However, in majority of those studies we test a single compound or maybe set of compounds.

The approach of big pharmaceutical companies is different nowadays.

The genomics research changed a lot in the drug discoveries and pharmacy research predict many receptors and so on for the human organism. First step is to find the molecules that fit into the receptors or enzymes like a key can feet into lock. It is not a simple task. Because the information is encoded in the DNA, it is placed in 1-dimension order. But, after production of the protein, the protein undergoes bunch of changes, attach other type of non-peptide molecules (so called post-translational modifications). The proteins bent and twist and convolute and whatever you can imagine happen with them, do happen.

Eventually all take 3-D complicated shape. It is possible to predict often (after accumulation of the knowledge for decades, using very expensive, slow methods) how will the protein convolute now and a how will it look after all.  However, that prediction requires significant knowledge databases and a lot of understanding and powerful machines, which calculate how the protein may look. It is similar to the way like in computer games a machine, using some very simple bits of codes, creates elaborate colorful battle scenes.
All I can guess – those machines are expensive and software is quite expensive too. Ok, if for a computer game maker you need on average from 1 to 10 million dollars these days, how expensive it would for drug discovery software? Obviously this process even more expensive, because there are more data and because the customers are only single companies – small team of scientists

Today it replaces100 times more expensive method of trial and error, if you would first synthesize all of those different thousands of compounds and try to test it on the minuscule amount of the available protein (that is also very expensive to produce).

But actually, of course, both approaches are used – they tune and refine everything in the process of the pre-study.

So, the goal first is to look the substances that may interact with each other.

However, compounds found during a computer simulation still require check in a biological system to see if they work.
Then (or simultaneously, or before the computer simulation) the scientists test thousands of compounds in the test-tubes. Actually they are often not the tubes bat rather plates with small, even sometime tiny wells. Chemical and cell cultures are added and the chemical effect is checked. Some work. Some do not. Basically, it is screening. To check if just few out of several thousands compounds are useful.

After that, it is useful to test the biologicals not just in the wells with limited amount of chemicals, but in the live systems (bacteria or fungi usually). It is more expensive and time consuming

However it is also automated in big companies nowadays and sometime 100,000 or more bacterial cultures are grown simultaneously to see if the desired chemicals may work in the biological system.  To select the desired effects, there are antibiotics often used. They kill undesired bacteria and leave only the bacteria with the useful parameters.  To learn about it more, read about recombinant and other genetic and biochemical technologies elsewhere.

Ok

Let’s say some compounds were found to be promising.

Now, the company is going to more expensive study and time consuming - testing the chemicals on animals.

Testing on animals is still pre-clinical study. Though, some people argue against using the animals in studies, it looks like those people have just consumer mind set, which acts only on emotions. How to test, then? Is there any alternative? Right away test on humans? Why would not this people volunteer? Besides, millions of animals are killed daily to feed the population; millions of chickens are grown in torture conditions and converted to hamburgers. Nobody objects.

For example, those or similar people complain that wind power mills kill birds.

A well-dressed girl,  graduate from an ivy league school, talks for about hour and half how bad is the wind power. Are there only such brainless ones in those schools? She also talks that she is against hydropower, against nuclear power, against burning coal. And she states, there are plenty of those people around. Well, probably.

However for me, it is hypocrisy, either acting out of emotions only, or deliberate withholding the information.
When I look at statistics, I see that in an area of 4000 power windmills, around 4000 birds die in year. Compare that to many thousands of birds dying in an average town yearly form infections, pollutions, diseases etc, or millions and billions of chickens killed for food, or burned because of bird flue.
Another thing when you look at that talking girl, you see she is dressed in very nice suit. To make the cloth for that suit, you need to build plants, get oil or gas and produce synthetic fiber or seed  huge areas with cotton seeds and grow, grow, grow, and consume  truckloads of energy, just to make one suit. And so on - every step in production would require huge energy spending. She also probably lives in nice house, and to produce brick, glass, cement and lumber, you again need to spend innumerable amounts of energy. Then, she probably heats her house and takes showers with hot water and so on. She refrigerates her food, she uses air conditioners and that’s all a lot of energy. Much more then she did by her blabber talking.

She drove into the studio in a big, energy - hungry car. To produce that car and later to maintain it, also requires a lot of energy.
And so on and so forth.
Even let’s say to produce solar power cells, you need to waste enormous amounts of energy, this is why the cells are so expensive.

Why wouldn’t she live in a cave without energy? When I see her living in wild for week or, for the purity of experiment, for 5 years, without complaints, then, yeah, then I might say, you actually have a point, I need to think about that.

Before that it is just the show of emotions.
Interesting, that this type of thinking (or rather not thinking, just acting) is exploited by different advertisers and mind manipulators. Another example of the ridiculously famous statement: You can see everywhere the phrase – we need to use hydrogen cells for power because “the hydrogen is the most abundant element on Earth”.
Yeah, we need to use hydrogen. However, seeing this ad, I get very bad impression – is it that engineers who produce fuel cells are so stupid. Maybe they can not think at all and could not think out how to make any fuel cell, if they make such statements? I guess the engineers are actually smart.  But it looks their bosses hire idiots for the marketing campaign. Anybody, who finished a high school and have half brain, knows that the hydrogen in the Nature is bound to something – like in water it is bound to the oxygen. Basically it is already burned out hydrogen. There is no free hydrogen in the world (maybe somewhere at extreme conditions in space or Earth core).
To extract the hydrogen from the water or whatever other sources, you need to spend a lot of energy.
And where would you get that energy. From another fuel, which you need to burn first?

These all are examples of the consumers mind.   It is easily exploited by different, usually not very honest people. Because the logical and honest facts and statements do not these tricks – mind games with emotions. And those emotionally targeted ads and opinions are aimed to control the mind of people who do not think, or do not want to think, or can not think at all. Yeah, it is much easily to consume the food half- digested by somebody else. Less work.

OK, let’s return to our topic about animal testing. So, to avoid human suffering and unpredictable outcomes, scientists test the potential drugs on animals first.

Anyway animal testing shouldn’t be cruel. And it is not in the modern science.

The animals in the lab cages live much more comfortable lives than their counterparts in wild, who die form diseases and starvation in the earliest childhood.  If out of 10 puppies 2-3 would survive to adulthood in the wild, they are probably lucky.
There are even guidelines - for example, not to grow a tumor in animals more than a certain size and euthanize the mice by some meds, to not allow them to suffer.
Just compare how cruelly you kill a mouse with a mousetrap, or your cat rips off her head. I do not know what is better for this animal.

Majority of the studies are designed to use as few animals as possible to avoid all that suffering without reasons. Besides, housing the animals is very expensive.  Special mice may cost couple hundreds per head, and rare, genetically engineered - even thousands, In addition everyday you need to spend, I would say, 1-5 dollars, and maybe even more if special conditions required. Not so many dying people in developing countries have this kind of luxury.

 So, you may know that the humane and proper care for animals is ensured.

What do they look for in animal experiments?
1. Are there any special problems with biological system? For that reaserches use more than two different species of animals.  What could be ok for one species may be not so good for another. Checking several types, helps to avoid problems with humans. For example they test rats and rabbits. If it is possible, monkeys are involved, as the closest to humans.
2. First question to ask – what the drug effects are and how toxic the drug is.  Side effects of the drug are determined and the doses at which this side effects are seen, recorded.  Later this side effect might be found on the label of the drug you use. It might be not that those affects would affect you, because the doses, when they test a drug, often ten-twenty folds are higher and even sometime hundreds times are higher than the eventual doses, checked in human trials. Anyway the possible reactions (even at those high does) are written down on the label.

However, you see, any chemical could be toxic for your body, if you use enough high doses.

For, example let’s say you drink a bucket of purest water in five minutes at once. Maybe there water is the purest and best from a freshest spring; you probably will feel sick anyway from such high dose in the short period of time. The same goes for food or drug.

3. They test if the drug have unusual toxicity

Those steps - to check what the drug does to body are named pharmacodynamics.

4. Now, after that, after the testing what you could expect form the drug, researchers try to get the clue, how the drug would be metabolized in you body.

Let’s say you found a very good drug for chronic disease; however, when you give it to patient, his liver destroys the drug in 3 minutes. In majority of cases this drug would be useless for chronic disease – you can not feed patient every 3 minutes with a pill.

This is just an extreme example, but what they do – is named pharmacokinetics – how soon the drug gets into patients blood or target organ and how soon it is removed.

5. They also check if the drug becomes toxic after the breakdown. Some drugs that are not toxic at all, after treatment in liver, breaking or conjugating with some other chemicals, might become toxic.
Sometimes, those breakdown metabolites are more effective than the original drug. This is also taken into account,

Let’s say they found that the compound have some potential future- not very toxic and has some medical desirable effect.

OK, after that they go to clinical trials.

 Look in Part 2.

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