For the last week, I have had a terrible cold.  I still have a cold.  My head has been stuffed for 7 days now.  I ‘m still coughing so hard and I can’t sleep laying down.  This week has, in general, sucked.  I’m tired, and cranky, and tired of being sick.  In general, I’m not a big fan of cold remedies.  I subscribe to the idea that they simply push off the symptoms rather than cure them, making a cold last longer.  So aside from some Cold Calm and the occasional anti-inflammatory when my head hurt so bad from the pressure every time I coughed that I wanted to cry, I’ve been pretty much cold medicine free.  I have my vitamin C and zinc, my steam humidifier, some eucalyptus and peppermint oil, and cough drops next to the bed.

One thing I haven’t been able to escape as far as “drugs” is my inhaler for my asthma.  I don’t have bad asthma, I don’t have to use an inhaler except for when I have a bad chest cold.  My lungs are simply incapable of dealing with all that mucus and after a coughing fit I end up not able to breathe hardly at all.  And I happen to like breathing, so I figure I’ll use it.

All this has led me to thinking, since I have a lot of time to think since I’m not doing much else.  I’d rather not take pharmaceuticals, however I do believe they have a place.  I am glad there’s an inhaler to save me.  I’m glad for the chemotherapy that reduced my tumors.  Pharmaceuticals are so important, yet so expensive here in the US, and sometimes it can seem like the pharmaceutical companies are predatory in selling drugs to the public.  And I’d have to say that yes, it certainly seems that way.  I work for a pharmaceutical company in a research division, so I have a semi-insiders perspective on how it all goes down and why it works the way it does.  I’d like to share what it is I know about the pharmaceutical drug discovery process.  Please understand I’m simplifying a lot, so all you chemists out there will probably furrow brows but I hope I’m basically representing it right.

How do pharmaceuticals work?

Well, your body usually works via complex chemical signals, and has lots of receptors of different shapes and sizes that receive chemicals that tell it what’s happening and what to do.  In the earlier days, pharmacy companies would figure out a known natural chemical that had an effect on the body (let’s take willow bark for an example), and chemists would try to isolate that molecule, or bend and shape other molecules to mimic that shape, and put it into a pill so that it could be used just like the original.  Nowadays it’s more likely that chemists take research that has looked at the chemical signals for a given condition, and they try to bend molecules to mimic those shapes.  The molecules that they come up with have to try to only fit into the targeted receptor, not other receptors.  This is not an easy task.  When molecules fit into other receptors they can set off other processes that you didn’t want to happen.  This can cause what’s known as a “side effect”.  So they add little spikes and odd bends to a chemical in order to try to get around that.  (I’m definitely simplifying here, I couldn’t tell you HOW they work with the molecules, they just do).

1. Pharmaceuticals Are Expensive!

Yes, yes they are.  Especially those brand-name ones.  Why?  Because bringing a drug to market takes many years and hundreds of dedicated professionals who have families and need to get paid.  In the early stages, chemists are looking at thousands of chemical structures, trying to determine which ones may have potential.  Out of those thousands, maybe (just maybe!) ONE will make it through to market.  Out of those thousands, maybe 100 will even get to the next level and be seriously studied.  Those 10 that need to be studied go through rigorous testing procedures to attempt to understand how well they work and if there are dangers/side effects.  This testing takes a long time.  If it’s determined that they work well enough, and don’t seem to have terrible side effects and don’t seem to be dangerous, then they move on to the next stage, where more scientists have to determine how to best administer the chemical, and to make sure it’s safe and stable.  Maybe 10 of the original thousands makes it this far.  They then perform tests on it to see how well it works when it’s put into pill form, or IV form, or whatever.  They see how well those pills last sitting in your cabinet, so they know what to put on them as a safe expiration date.  They see if the pills will break down correctly in your digestive system to deliver the chemical in a timely manner.  They test to see if it will absorb correctly and do what it’s supposed to do when it’s in pill form.  During this stage many of the drugs don’t pass because there are significant issues that outweigh the benefits of the drug.  So, we have maybe 3 out of thousands that seem viable and pass all the tests.  These 3 get to human trials.  First there are the limited human trials, with a small population of targeted people.  Out of the 3, One of these may show significant enough improvement in whatever it’s trying to cure to be worth pursuing further.  That one will then go to larger human trials.  And maybe (just maybe!) there won’t be significant enough side effects, and the effects of the drug are significant enough to set it apart from other drugs already on the market, and it can be sold.

Another part of why drugs are so expensive is patenting.  Drug companies patent a chemical structure when they decide to go ahead out of the original thousands with it.  The patent expires in a number of years, but many years of that patent are eaten up during the process of getting it to market.  So pharmaceutical companies are basically trying to make back all the money that they spent on research, development, testing, and manufacturing of that drug (and the thousands that didn’t make it that far), and to make money to support future development, and they only have a few years to do that.  As soon as the patent expires, the active chemical ingredient may be manufactured by other companies to produce “generic” versions.  Is this a good excuse to charge so much?  I don’t know.

2. Are Pharmaceuticals Safe?

It seems like every week there’s new commercials from lawyers talking about the detrimental effects of some drug or another you may have died from.  It’s enough to make you think that pharmaceutical companies aren’t doing their job making sure drugs are safe before they hit the market.  I can only speak for the company I work for, but safety is VERY important.  Considering the potential liability, it should be!  The drug testing process is mandatory in specific things that must be done in order to put a drug to market in the US and EU.  That said, drug companies try to do the “right” testing in order to minimize costs, and to get the drug to market before the patent expires.  They do at least the minimum testing required, and often more.  Animal testing and human trials may not show an issue that will show up when the drug is given to a much wider audience.  Why is that?  Because we’re all different in genetics and in experience, our bodies all react differently.  A drug that may work for one won’t work for another.  A drug that may work fine for one person may harm someone else.  Then there’s long term studies, which aren’t really feasible when you’re rushing to market.  Just like household products and chemical manufacturers, nobody has done long term studies (20+ years) on anything, because that “halts progress”.  If you think about it, if aspirin were to go through the regular drug discovery route today, it might not even make it to market.  Personally I don’t know the viewpoint of executives on this point.  From what I have heard them say, it seems to be a balance to them, the opportunity to save many many people, but the risk that some people may be harmed.  Is that wrong? maybe.  It doesn’t mean all pharmaceuticals are unsafe, it just means that you should be aware and only use what you really do need.  The reward has to outweigh the risk, and if the risk is a heart attack or death, you should take that seriously.  My takeaway from this is not to use new drugs until they’ve been on the market for a while unless nothing else has worked for you, and always check the side effects before you buy.  Your pharmacist will be able to help you determine what they are before you purchase.

3. What About Generics?

I’m going to tell you something they won’t say on the corporate news channels.  Generics and brand names are equivalent, but not the same.  Don’t let anyone tell you otherwise.  What is the same is the active chemical compound, the molecular structure that’s supposed to do the job.  What is NOT the same is everything else in that pill.  The manufacturers of all the supplies, all the adjuncts, the process/formulation (recipe) of how it all fits together.  Is this a cause for concern?  Possibly.  What does it mean though?  It means that the rate of absorption and effectiveness of the active molecule may be different.  So while one manufacturer’s version of a drug may work for you, if you switch to another manufacturer you may get different results.  For example, you may be able to take one pill before breakfast, but with another manufacturer you may need to eat with food to avoid side effects.  One manufacturers pill that may absorb well for you to work for 12 hours.  Another manufacturer’s version of the same medication may not work well for you, loading more up front and tapering off too quickly.  Does this mean that you will always see a difference?  No.  You could feel no difference between two manufacturers.  There’s also a chance you could.  From first-hand experience I can definitely tell you it happens.  Now, this doesn’t mean that the brand name is the best choice for you, it may be that a generic is best for your body chemistry.  The takeaway from this is that if you switch from one manufacturer to another, keep your eyes open and give your body time to adjust, but be aware that there are other options if it’s not working as it should.  There is often more than one generic manufacturer for a drug, and you can ask for another.  Your insurance, however, may charge you more for that other manufacturer’s pill because it’s not their “preferred” vendor.  Is that wrong?  probably.

In conclusion

Boy that was long.  I hope it was informative, and makes you consider what perhaps we as a nation can do to make pharmaceuticals available at a decent price to those who need it.  It’s a very complex issue, and I don’t know that there’s a simple solution.

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