We are all on drugs, yeah....

So, this semesters, I'm doing my paramedic pharmacology class. For part of this, we have to write a term paper on something drug-related. In doing this, I discovered some things that even surprised me.

It takes an average of 12 years to develop a new drug, from formulation to FDA approval. However, the pharamceutical company must file for it's patent on the drug once the new formulation is created. This patent is only good for 20 years, and cannot be renewed upon commercial viability. So, 12 years on this 20-year patent is gone by the time a company can actually sell the drug.

After this formulation, the drug company starts animal testing. This determines the potential safety and efficacy of the drug.

After this pre-clinical phase has shown some potential for the drug, the company must file an investigational application with the FDA before it can begin human testing.

By the time the drug company is ready to submit an official application for the drug, it will have conducted research on nearly 5,000 people in a minimum of three seperate double-blind clinical studies. The final FDA approval process then takes up to three years before the manufacturer finally receives permission to sell the drug.

So at the end of this process, the drug company only has about 8 years of exclusive rights to market the drug that has cost the pharma company nearly $1,000,000,000 to develop. However, there is a chance that even after this one-billion dollar drug has made it past clinical trials, the FDA will not grant approval.

And only about 1/3 of all new compounds will ever make it past the second clinical trial. So for every drug that is approved at a cost of one billion dollars, about 2 drugs will never make it to approval stage, each at a cost of about $100,000,000.

Then you see the commercials about how "grandma shouldn't have to decide between eating and taking her pills." Have you ever stopped to think about what people did before they had all these pills? And how many of grandma's problems are caused by other pills, so the doctor gives her another prescription to fix the side effect of this prescription, and soon grandma is taking a handful of pills each day, just because the doctor told her to.

The next time you see a politcal ad about the need for stricter regulation on the pharmaceutical companies, just think about the 1.2 billion dollar price tag on that little pill up in the cabinet. If you start to limit the money that drug companies can make, you take away their incentive to develop new drugs.