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Those Evil Pharmaceutical Companies

Pharmaceutical companies are easy to despise: they make billions (yes, billions) of dollars from the sales of a single drug, often charging several dollars for  a tablet that cost them pennies to make.  Oh, yes, and then there are the (sometimes undisclosed) side effects, which might include damaging your liver, causing  heart problems, precipitating  the onset of diabetes, or gaining a large amount of weight-not to mention the "minor" side effects of dizziness, nausea, insomnia, headaches, sleepiness, etc.  While you are experiencing the side effects, there is no guarantee that the drug is lowing your blood pressure, decreasing your chance of heart attack, making you less depressed, or whatever you actually are taking the medication for.  As a result, you may end up paying  a lot of money for a medication that neither furthers your health or your sense of well-being, but does empty your wallet and make you feel ill.  How can this situation continue unquestioned?

A medication that you are taking, replete with side effects, started its winding path to FDA approval many years ago.  Screening for drug candidates is a mind-numbing process-some pharmaceutical companies screen as many as 100,000 compounds a day, looking for a drug that has medicinal value.  Then the day comes: a truly promising drug candidate-and a heady day it is.  I've been involved with drugs that didn't just shrunk human cancerous tumors in mice, but destroyed the tumors; with antidepressant drugs that appeared to have no side effects  provided relief faster than existing drugs; and an anti-hypertensive that lowered blood pressure more effectively than a  combination of existing drugs (thus avoiding drug-drug interactions and multiple side effects). While these candidate drugs may be cherished by management for their money-making potential, they are endeared to the rest of the pharmaceutical company employees precisely because the employees are involved in a project that may help thousands, if not millions of people (I personally was involved in the development of  an anti-cancer drug that would later in life be deemed responsible for giving a step-aunt  three good years after a  diagnosis of lung cancer). 

 Perhaps you can understand the enthusiasm these drug candidates engender in those scientists and project personnel developing the final "product".  But on the way to FDA approval (required to sell the drug to the public), safety and efficacy clinical trails are required, along with extensive chemical characterization and purity testing-to mention only two hurdles.  It is often in these studies that very difficult decisions must be made...what if that fantastic anti-cancer drug sometimes causes liver problems?-to put it more personally, if you had a terminal cancer condition and you were offered a drug that would give you a much-extended life or perhaps remission, but might cause liver problems, would you be willing to take the medication if no other treatment was available? You be the judge: in the current discussion, would you suggest the pharmaceutical company proceed developing the drug, since it potentially could save  lives, or should it be discarded because of the chance of liver problems?

Things are getting complicated, right?  If  1% of the people taking the drug  experienced  liver problems, you might come to a conclusion different than if it were 90% of the people taking the drug-but wait, maybe a person with a terminal disease would be  willing to take the drug, deciding that a 10% chance of response or remission of their cancer was a better chance than zero.  The point of this example is simple: it's really hard to decide with real drugs, almost all of which have side effects, what is acceptable and what is not acceptable. To add yet another variable, would you suggest progressing a drug for athlete's foot that had the potential to cause significant liver damage? But I digress from the progression of  a drug candidate through the internal process of development, which I'll continue in the next entry







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