In response to the nation's opioid addiction crisis, the FDA scheduled a hearing in Silver Spring, MD to discuss about how to get this serious problem under control. The Council was asked to provide input and President Hank Campbell and Dr. Josh Bloom, Senior Director of Chemical and Pharmaceutical Sciences, attended on March 1st.
Though the external advisors were a group consisting of physicians, NGOs, even a drug company — only the Council discussed the cause of the current upswing in overdose deaths: Colloquially called heroin but more specifically, fentanyl, a super-charged chemical cousin of heroin that is 50-100 times more potent.
Dr. Bloom pointed out that not only is fentanyl very simple to synthesize, but is so dangerous that two milligrams — the weight of a few grains of salt — is considered to be a lethal dose. He described the opioid problem as a twisted version of the "whack-a-mole" game, which got the attention of the committee. When one drug becomes more difficult to obtain, another one pops up to take its place. The following is as good an example of the law of unintended consequences as you'll ever see:
The red arrow represents the date when a highly abuse-proof formulation of OxyContin, a major contributor to the surge in addiction, was approved by the FDA. When addicts tried to grind up the pill and snort or inject it, as they had done before, it turned into a useless gum instead of a powder.
OxyContin use fell off a cliff, which sounds good, until "whack-a-mole" began. Former users turned en masse to heroin, and overdose deaths more than doubled in three years. Worse still, what is sold on the street as heroin is very often fentanyl, which is far more dangerous.
And, with the surge of heroin use came needle sharing, which caused outbreaks of HIV and hepatitis C.
We at the Council have always maintained that simple answers to complex problems rarely work, and often make a bad situation worse.
Dr. Bloom referred to fentanyl as "the devil in the room" so the other participants may have failed to recognize it before, but at least they see the problem now.