All pharmaceuticals in the United States must go through an approval process by the Food and Drug Administration (FDA) through its Center for Biologics Evaluation and Research. Drugs for ADHD and related comorbid conditions are no exceptions. To have a drug approved, it must go through a long, rigorous period of development and testing and then close scrutiny once it gets on the market. It may take 10 to 15 years for a new formulation to come to the market.

Drugs are tested using controls. The control may be a standard treatment or a placebo. A placebo is an inert compound identical in appearance to the material being tested, which may or may not be known to the investigator and/or patient. For example, in a controlled clinical trial, a control group might receive a sugar pill (the placebo) instead of an actual formulation. If neither the person giving the pill nor the person receiving the pill knows whether it is a drug or a placebo, the study is called ''double-blinded.''

Safety concerns may arise at any stage of animal investigations or clinical trials. If this happens, the FDA may request that more information be provided. If the data show consistent adverse events (AEs), the manufacturer or FDA may suspend the trials. Common AEs are determined by comparing the number of cases in those receiving the treatment with those receiving the placebo. If more AEs occur in the drug recipients, the drug may be the cause of the reaction.

AEs and side effects are different. An AE is something that occurs at the same time as the drug trial and may or may not be caused by the administration of the drug. A side effect is a reaction that is caused after the drug is administered. A rare side effect, such as 1 in 10,000, may not be detected because the numbers of participants in the trials are not large enough to spot these rare conditions. In addition, Phase IV trials or postlicensing studies may be conducted after the approval.

Various words and expression are used in the scientific community but have a completely different meaning for the public. The following are some examples:

- To the scientist an AE is something that occurred at about the same time as the trial and may or may not be related to the trial; the public thinks an AE or side effect is something caused by the drug.

- Naive means the person or animal has not previously been exposed to a particular infection, drug, or vaccine; the layperson thinks the term means unsophisticated and lacking experience or training.

- Significant means that the results may not be due to chance; the public understands the meaning as ''important.''

- Safe means there is a remote or insignificant risk; the public thinks that it means that there is no risk or zero risk.

Bibliography:

1) U.S. Food and Drug Administration.

2) Myers, Martin, and Diego Pineda. 2008. Do vaccines cause that? Galveston, TX: I4ph Press.

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