On March 4th, 2016, I testified at FDA about the opioid addiction crisis in the U.S.
Other experts spoke about the obvious stuff — over-prescription of drugs such as OxyContin, Vicodin, and Percocet, and gave their opinions about who was to blame — I was the only one who mentioned the most important cause of overdose deaths: fentanyl. You have probably heard of it by now, it is an extremely powerful opioid that is used medically for control of severe chronic pain and general anesthesia. On the street it is a substitute for heroin.
A few weeks later I was on the phone with the Wall Street Journal explaining that it was fentanyl, not heroin, that was really the looming crisis. When I spoke to the FDA Science Board about opiod addiction, I called fentanyl "the devil in the room." When we heard about the death of Prince on April 21, we predicted what the cause would be and now it is known that it was this devil that killed him, according to the just-released medical examiner report.
I presented the following graph to the FDA:
The graph gives as good an example of the law of unintended consequences as you'll ever see. In 2010, the number of deaths from opioid pills had leveled off after 10 years of rapid, steady growth. But "heroin" deaths went through the roof. While everyone else was blaming doctors and pharmaceutical companies, I discussed that it was instead a blanket demand for abuse-resistant opiods that was the cause.
In 2010 Purdue Pharma, after years of formulation research, got FDA approval for a new version of OxyContin — a high-dose, extended release form of oxycodone. Prior to that, addicts knew that by simply grinding up the pill, they could defeat the extended release formulation, and get as much as 80 mg (16 Percocet pills) of pure oxycodone.
The new formulation put a stop to this, since when users tried to grind up the pills, they got a gum which could not be easily used. OxyContin use fell off of a cliff, as desired, but the solution was problematic. Addiction is a demon, cutting off one supply does not cure it, and addicts switched en masse to heroin (red arrow above), and the number of overdoses more than doubled in just three years.
While heroin is much more dangerous than oxycodone, the greater problem is that "heroin" isn't even really heroin any more. It has been largely replaced by fentanyl, and fentanyl is not only far more dangerous than heroin(1), but it can be synthesized very easily by any trained organic chemist. Most of it comes from labs in China and Mexico. And, since it is so much more potent than heroin, far less needs to be smuggled into the U.S.
It is this extreme potency that makes it the devil in the room. A fatal dose of fentanyl is about 2 milligrams — roughly equal to the weight a few grains of salt. This is why it is so dangerous. A small error in cutting the drug can easily turn a "high" dose into a fatal dose.
Although it can never been proved, it is very likely that Prince died in just this way. Despite his wealth and fame, the star suffered the same fate as junkies who die on the street every year — addiction to pills followed by progression to something that is much worse, and also cheaper, and easier to obtain.
What a mess.
(1) Fentanyl is 50-100 times more potent even than morphine.