Chemistry and Pharmacology

Chemistry and Pharmacology

If you've ever had bronchitis, laryngitis, or any other –itis, chances are you've taken some antibiotics. Did you know that little pill you took was studied for more than ten years before it made it into your pharmacy? No, it didn't take so long because chemists are lazy. The scientific method is a complex process, and results often have to be studied for a long time before we can be sure a drug doesn't do more harm than good. Because that would be awkward.

Developing a new drug usually starts in a chemistry lab. As scientists learn more about a disease, they can use what they know about existing chemicals to develop a drug to help stop or reduce the effects of the disease. For example, zidovudine, or AZT, was originally created to treat cancer, but researchers found that it didn't actually work against cancer cells. Bummer. They continued to study AZT and later found that it was effective in reducing the effects of HIV/AIDS. Now it's an antiviral drug that's commonly prescribed to treat HIV/AIDS patients. Definitely not a bummer.

Once that drug is developed, it goes through all kinds of research in the laboratory and on animals to determine how safe it is. This is where the scientific method comes in really handy. Scientists can ask a question, like, "How does this drug affect reaction time?" Then they can design and perform an experiment to answer that question. This process gets repeated tons of times to answer all kinds of different questions about the drug. The results of these experiments help scientists decide how much of the drug should be given, if there are certain people who should not take it, and if there are any side effects (no one likes excessive hair growth, double vision, or uncontrollable gas).

Once the drug has passed all of these tests, it's allowed to participate in clinical research where it's tested on actual real, live humans. Again, scientists follow the scientific method to come up with logical, ethical experiments that will help answer their questions about how the drug affects humans. These tests ensure the drug is safe and actually does what it's supposed to do. Can stuff go wrong here? Yes, but usually by this point, the drug has undergone so much testing that it's very unlikely that it ends up causing harm.

After the human guinea pigs are done with it, the Food and Drug Administration (FDA) reviews the results. This part of the process is like a super intense version of the peer review that happens before an article is published in a journal. FDA review teams will look at how the study was designed, how the data were collected, and what the scientists concluded. Then they'll either give the drug the okay to be prescribed, or they'll say no way and researchers will have to address any issues with the drug or their study before they try again.

Don't think that once a drug gets the okay that it's all smooth sailing, though. After a drug is approved, the FDA still monitors data on that drug to make sure they continue to be safe for humans. So the next time you're sick or hurt and need medicine, thank the long line of very patient scientists who worked their way down the very windy path of the scientific method to make you feel all better.

Still curious about this process? You can find out more straight from the horse's mouth.