As I began to realize the extent of Big Pharma's influence on the medical sector, it seemed to me they were bribing their way onto the prescription pads of doctors. The pattern was too obvious to ignore and it was happening right in front of my eyes, both in Canada and the USA. I started to ponder, why was this happening?
(If you missed Part 1 of this serie, you can check it out here before continuing)
So I spent a lot of time thinking, watched many documentaries, read many articles, and dug into my own experiences. Was it really a bribe? Or the consequence of something bigger? One thing we learn as scientists is to approach a problem logically and methodically, before drawing any conclusion. So before I judged Big Pharma, I had to consider how a drug is developed in the first place. It takes three phases.
Before we even begin to speak of a drug, science must establish a solid ground for it, and that begins with fundamental research. Fundamental research is the most crucial step. It provides a very rigourous scientific understanding of the cellular mechanism in disease. Or just the normal function of the cell. And by studying cellular or animal models, researchers gain knowledge which they share with the scientific community on an international level. Simply put, we (scientists) submit our research to a journal (Nature, Science, Cell, to name just a few big ones), where it is reviewed by randomly chosen referees (themselves researchers). So when you read a scientific article, you can be assured it passed those barriers and that it will gain a wider acceptance.
Research can be academic (funded by the government, NIH, or other public sources), taking place in universities and executed by professors and their undergrad/graduate students, like I was. Or, research can be industrial, executed in the big pharmaceutical labs, with much much higher funding and resources. The big difference is the publication. Academic researchers are forced to publish their works; they have to keep up with a certain level of publications, or their funds won't be renewed, and labs can litterally close because of that. On the other hand, industrials don't need to because they have plenty of Wallstreet funding. In fact, they often keep their research top secret, but they can freely feed on what academia is doing and build on that. Talk about hypocrisy. Pubmed is where all the articles are referenced, so anyone can access it. Some journals are free access, some aren't (unless you're accessing from a campus with paid subscriptions).
Academic research is considered cheap labor. It's difficult to get funds, the competition is fierce, and students are paid just enough to pay their bills and expenses. So for a company like Bayer running a joint research with university labs, that's a bargain! Fundamental research is very tedious and takes patience and time. The cellular mechanisms are extremely complex and almost fractal: so many overlapping pathways, so many proteins in play, it's mind boggling. Studying only one cancer pathway will made your head spin faster than a pulsar Check this link to get a glimpse of the pathways complexity.
Once the fundamental research is complete (to a satisfying degree), the pharmaceutical company can start its drug discovery process. There are many ways to achieve that, in vitro (biological or biochemical assays) or in silico (computer assistance). Such screenings can start with a pre-existing library (say 50,000 molecules) and yield one or several candidates.
Another more efficient way is that by knowing a protein's 3D structure (NMR, X-Ray crystallography), it's easier to design a drug, instead of throwing a bunch of molecules into a sieve and hoping to discover something. It's like having the lock (protein, enzyme or receptor), and designing a key (drug) that will fit it specifically. This approach is not very common though, because not all proteins can crystallize or can remain soluble for NMR studies. But it's the cheapest way to find drug candidates, because computers are used. Afterward, the challenge is to synthesize the molecule, with the help of organic chemists. Sometimes it's easy, sometimes it's not.
Finally, the candidate needs to be tested in vivo, that is in live animals. Yes, it's a requirement. Whether we like it or not, animal testing is here to stay. Without animal testing, we can't be sure if the drug will work in humans at all, that's why we should be thankful that animals are (forcefully) giving us their lives in order to save ours. Animal testing can range from mice, to rats, rabbits, sheep, dogs, or pigs (yes the pig a good model because of its closer size to humans). Of course, mice testing is way cheaper than pig testing, but it really depends on what's being researched. Certain immune diseases for example show a closer correlation between humans and mice, vs humans and rats, or vice versa.
This is the most popular phase people hear about on the news and TV, rarely does the media cover the hard work being done before reaching this level. After being tested and retested in vitro and in vivo, the most promising drug candidate can move on to the clinical trials. That's where healthy volunteers are paid to be lab rats, and if everything goes fine, the drug can happily continue its journey into the bloodstream of a small pool of volunteer patients bearing the targeted disease. Again, if that goes well and the results are encouraging, we move to the final step with a larger pool of volunteer patients. Clinical trials include extensive studies of the the drug's metabolism, elimination, efficiency, toxicity, side effects, etc.
That was a little trip into the drug design/discovery process up to the clinical trials. It's an expensive process that usually takes about 10-15 years to accomplish, costing $1 billion or more.
In the next part, I will explore the financial side of Big Pharma (patents, prices, mergers). So stay tuned, I hope you're enjoying this serie so far.
"Rest, Neo, the answers are coming."
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If you missed the previous post, here it is:
Big Pharma, Part 1: My Awakening
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Love this post. I was in school for Practical Nursing and was going to get my degree in Registered Nursing but lost all faith in the pharmaceutical industry one day afte researching the harmful effects of vaccines.. I've stumbled across Naturopathic healing and I never looked back :) keep up the awesome posts!
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you should add a link to part 1
Right. I assumed people would have read part 1 by now. Good idea.
very informative bro thanks for sharing, I'm interested to see what angle you take with the rest of it xD
Yup, all coming in the future posts. I thought it was important to give an introduction on what truely happens behind the scenes, before tackling the big picture and how all those elements interconnect. It's a complex topic. I can easily say "Big Pharma sux", but it's more informative as you say to explain why I think that with a solid argumentation.
Read this series the wrong way round started at 3 then 1 and 2.
A question for this series,
There is natural remedy's that have been for a long time, so why do we really need drugs and drug testing on animals?
That's a good point. And the answer is simple. Traditional medicine and pharma drugs both have their own merits and limitations. I think they can complement eachother, not be enemies. As a matter of fact, the indian ayurveda and the chinese traditional medicine do not disregard modern medicine, on the contrary they embrace it when they cannot treat of a heal certain diseases, and will tell you to go to the hospital when they fail. But unfortunately the opposite isn't true, as modern doctors will not refer you to traditional medicine because they simple don't understand its value. It's endoctrination. Nevertheless, some modern doctors are open minded and do study alternative medicine, but those are rare. If your doctor is sincere, he will tell you to take a break and excercice if they see you're exhausted, and if that doesn't help, he will prescribe you something. A bad doctor will go for the pill, make more money, and call the NEXT patient.