Pharmacology companies are constantly striving to create new medications. There is just one teensy problem — it is not an exact science. The companies have to go through rigorous tests and testing phases to get approval from the FDA, and it takes years to get a medication on the market. Even after several clinical trials to make sure a medication is safe for the population, there is always the chance that a fraction of the global population will have an adverse reaction, either because of their brain or body chemistry, or because of a drug interaction not detected in clinical trials. Here is why pharmacology is not an exact science, and how everyone can address the side effects.
Clinical Trials Sample the Population
The idea behind clinical trials is to sample a cross-section of the population based on race, gender, ethnicity, and age. While the pharmacology companies try to include a good sample of all of the above, they may not find any adverse effects, even if they test each of these groups of people separately. If and when the patients in all of the clinical trials do not present with any negative side effects, the documented trials are then presented to the FDA to receive the final green light to begin manufacturing the drug and selling it.
Side Effects After the Drug Has Been on the Market
Pharmacology companies frequently encounter people who start taking a new drug and all of sudden have very bizarre side effects that did not show up in the clinical trials with their trial patients. Faced with these new and unexpected results, the companies turn to pharmacovigilance consulting groups. These special consultants take a look at the new side effects patients are now experiencing to determine if the drug should be pulled, or if additional tests need to be conducted in a lab setting to find out why all of these other people are reacting to a drug negatively.
The idea is to find out why just these people are responding to the new drug the way that they are. There is usually a biochemical reason, a chemical dependency reason, or a drug interaction that was not tested in all of the research the drug company did before being allowed to manufacture and market the new drug. If a link can be found, the drug may not have to be pulled. Patients with a particular medical profile would have to be screened and warned of possible drug issues before being prescribed the new medication.Share