The testing required for every drug, steroid, or supplement before it can hit the market is extremely rigorous. Scientists have to be meticulous and precise on a daily basis.
For instance, should scientists have to move to a new lab in the middle of their testing, as may happen if they accept a new grant or another source of funding, then professional lab movers are hired to make sure that all samples and compounds retain their structural integrity during the storage and transportation process. Even a small change in temperature that destroys a certain culture could set the experiment back months or even years.
Here are the five steps that a new drug goes through before it can be released to the public.
- Initial Research: When developing a new supplement, a team of scientists will examine hundreds of botanical compounds to isolate the nutrients that they are looking for. After comprehensive testing, they will be left with only a few that they consider effective. These selected compounds will then be subjected to further experiments to identify their mechanisms of action.
- Screening for safety: Let’s suppose scientists have found a certain compound from a particular root vegetable that grows in the Amazon rainforest that offers remarkable benefits in increasing endurance. Since this is something that can be used as a supplement by athletes, it’s a marketable idea. They must now do preclinical research to see if the new drug is safe to use in human beings. For this, they might use white lab mice. Using this method, they will determine if their extracted compound is safe and what amounts are effective.
- Testing on people: Now that the extracted compound has been found to be safe on biological systems, the next step is to do clinical research on volunteers. Researchers will now develop a research plan, identifying who will benefit, how much they should use, and how long the results last.
- Presenting their findings to the FDA: Assuming that all goes well with the endurance supplement, the drug maker must now present these findings to the US Food and Drug Administration before it can be released to the public. The FDA will assign their own scientists to sift through all the data and verify all the findings. If the supplement is rejected, then the researchers can work to modify the supplement and resubmit their findings. If, say, the FDA scientists found that the endurance supplement resulted in insomnia, then researchers may have to add some inhibitory compounds to the supplement to make the effects less long-lasting. Once the FDA approves a supplement, it can be sold to the public.
- Public Monitoring: Unfortunately, not everything that passes the tests done by the supplement researchers and the FDA scientists working on verifying safety, dosage, and efficacy will work perfectly. This is why the FDA also monitors the effects of a drug after it has been released. Sometimes a large sample group is necessary before side effects can be detected. A famous example of how badly things can go wrong is ephedra. Under laboratory conditions and clinical trials, ephedra, which comes from the Chinese herb Ma Huang, was found to be an effective appetite suppressant, mood arouser, and energy stimulant. As a result, it would be perfect for people who exercised to help them lose weight. FDA researchers could not find any problems with the original studies. Unfortunately, upon release to the general public, over 800 dangerous side-effects were reported, including strokes, heart attacks, and fatalities. The reason why ephedra’s side effects were not noticed in research was that scientists tested low doses, at which level it was an excellent decongestant. But at higher doses, it raised blood pressure. As a result of people taking it in high doses or people with heart or blood pressure preconditions taking it, the drug was found to be unsafe and had to be pulled out of the market.
In conclusion, it has to be remembered that although scientists do their best to only release safe, effective drugs and the FDA does its best to verify all drug claims, the art of making supplements is still far from perfect. Consequently, it’s important to stick to dosage guidelines and to discontinue supplements that have unexpected side-effects.