What's wrong with the FDA? The answer may be contained in the FDA's “Guide to the safe use of pain medicine for consumers” (U.S. Food and Drug Administration, 2009, updated Aug. 30, 2015): “Pain medications are safe and effective when used as directed. However, misuse of these products can be extremely harmful and even deadly.”
But those who are vulnerable to opioid addiction may simply not be able to take pain medications as directed, and the FDA "Guide" does not make that clear. Dr. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA) has told us that the brains of addicted people "have been modified by the drug in such a way that absence of the drug makes a signal to their brain that is equivalent to the signal of when you are starving." It is "as if the individual was in a state of deprivation, where taking the drug is indispensable for survival. It's as powerful as that."
But the FDA "Guide" suggests that the FDA believes that those addicted to prescription opioids could have prevented their addiction. If so, it reveals a serious misunderstanding of the nature of addiction. Vulnerability to addiction varies, and addiction occurs among those who take opioids for pain just as it does among those who take opioids to get high. No one knows the percentage of those who have died from opioid overdose whose "career" of opioid use began with an opioid prescription for pain.
Given this reality and the widespread perception that there are two groups of prescription opioid users, "pain patients" and "drug abusers," it would help if the FDA required a statement like the following to be included with any patient whose physician has started them on prescription opioids:
"You may be genetically vulnerable to opioid addiction. This means that no matter how good your initial intentions are, no matter how strong you are, no matter how good your character is, you can be sucked into a whirlpool in which opioids become progressively more important to you at the expense of everything else in your life. The fact that your doctor is prescribing this medicine for you does not make you safe. The fact that you're taking this medicine for pain does not make you safe. The degree of vulnerability to addiction varies, but in general, the longer you take this medicine and the higher the dosage, the more likely you are to become addicted.
Make sure you understand this risk. Make sure, before you start this medicine, that you and your doctor have a plan to keep you on this medicine for the shortest possible time."