Drug Trials. Are You A Statistic?

The US Food and Drug Administration (FDA) is the agency that is supposed to control and regulate the food and drugs in this country. This should be a good thing since all drugs have side effects and the vast majority of Americans take some form of medication regularly. But do you know how the drugs are tested and at what stage they are cleared to be marketed to the general public. Yes if you didn’t know the United States and New Zealand are the only two countries that allow drugs to be marketed to the general public.

So here are the phases of drug trials according to the U.S. National Institute of Health.

Phase 1 : Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2 : The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3 : The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. (This is the phase for FDA clearance allowing the drug companies to market and distribute to the general public.)

Phase 4 : Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

Now if you are taking a drug that has been on the market less than 10 years YOU are part of the drug trial. In fact you are a paying participant in that trial. You have paid the drug company to allow them to do scientific research on you.

Scary isn’t it?