People assume that if a drug is approved by the FDA, it’s safe. Obviously that’s not the case. If it were, we wouldn’t be facing a prescription drug addiction and abuse epidemic. What many people don’t understand is how the FDA works. If you want to avoid the possibility of prescription drug addiction, it would be a good idea to understand exactly what the criteria are for FDA approval.

Prior to submitting a drug for approval, studies are done on cells and animals. If there are no disasters, studies begin on humans. The first studies, Phase I of the clinical trials, are usually done on between 20 and 80 people. If the drug shows promise, Phase II begins. More people are usually tested in Phase II, but it may be only about 100. If Phase II also shows promise, Phase III is begun. This phase may involve several hundred people, or several thousand.

While each step enables scientists to evaluate the effectiveness and safety of the drugs, researchers are supposed to determine how a drug will effect the general population in Phase III.

After Phase III, the benefits of the drug are compared to the risks, including the possibility of prescription drug addiction, and if the benefits are deemed to justify the risks, the drug is approved by the FDA and is made broadly available. But it is only approved for the specific conditions it was designed to treat, at specific dosages, and may have other guidelines such as warnings to not take the drug under certain conditions.

The drug company is then free to market the drug and Phase IV begins. While Phase IV no longer requires clinical trials, it is a period of surveillance and adverse reactions are supposed to be reported.

Only in Phase IV do we actually get an idea of what effects the drug will have when taken long-term and by patients who, while they may have the condition on which the drug has been tested, may also have other conditions not included in the clinical trials. Doctors may, at this point, also recommend the drug for things other than which it was approved, called off-label prescribing, although it’s illegal for drug companies to do off-label marketing.

So, why don’t we find out about things like the possibility of prescription drug addiction, hearts attacks or strokes, and a number of other side effects during this procedure?

In some cases, like OxyContin, the drug’s manufacturer lies to or withholds information from the FDA and the public – for which OxyContin’s manufacturer, Purdue Pharma, paid a fine of $634 million.

The drug has been tested on relatively few people - perhaps only hundreds - compared to the millions who may eventually take it. Many people may have conditions that were not represented in the clinical trials.

The drugs are prescribed off-label – given to people with conditions for which the drug has never been tested.

The drugs may not have been tested in combination with other drugs the patient may be taking. Drug combinations are often the cause of death with prescription drugs.

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