Listened to a really interesting story on NPR yesterday about a new opioid drug that is super potent and just recieved FDA approval despite the FDA’s advisory panel overwhelmingly recommending against approval. Most prescription opiates (e.g., vicodin, percocet) are actually denatured with acetaminophen (tylenol). This is not really for more pain relief, but to keep you from taking too much as the tylenol will destroy your liver before you get too high from the opiate. You might be interested to know, though, that acetaminophen and hydrocodone turn to solution in water at different temperatures, allowing the truly intrepid to get around this. I don’t recommend it. The reason Oxycontin is so abused is because it is pure oxycodone without being denatured. (It is extended release). On the positive side, since Oxycontin has been so abused, they have changed the delivery mechanism so that you cannot crush it and snort it for a quick high. Okay, so there’s the background.
Into this, steps the FDA approving Zohydro, which is basically like Oxycontin, except from the synthetic opioid hydrocodone instead of oxycodone. But here’s the kicker, the manufacturer says it may take up to three years to introduce an abuse-resistant version. That’s nuts! I’m not entirely clear why we even need this if we’ve already got Oxy for severe pain, but I do realize that some drugs work better for different patients, so an alternative to Oxy seems reasonable enough. But why wouldn’t the FDA demand that this come in an abuse-resistant form. Anyway, from NPR:
NPR’s Laura Sullivan reports.
LAURA SULLIVAN, BYLINE: When Zohydro is released next month, it will be one of the most powerful prescription painkillers on the market. It’s highest dosage will contain five to 10 times as much hydrocodone as the widely used Vicodin. The drug company’s literature says an adult could overdose on two capsules. A child could die from swallowing just one pill.
DR. MICHAEL CAROME: People are going to die from this drug.
SULLIVAN: Dr. Michael Carome is the director of Health Research for Public Citizen.
CAROME: We are in the midst of a public health crisis. There is an epidemic of opioid addiction resulting in thousands of deaths. And the last thing we need now is another high-potent, high-dose, long-acting opioid drug, Zohydro, that will simply feed the epidemic.
SULLIVAN: Overdose deaths and addiction rates from prescription painkillers similar to Zohydro have grown dramatically in recent years. Carome and 41 other healthcare advocates are asking the FDA to remove its approval of the drug. Zohydro is a crushable pill. That means it’s snortable and, some experts say, more prone to abuse than other drugs like the new versions of Oxycontin, which are no longer crushable…
DR. ANDREW KOLODNY: We have many opiate formulations on the market. There’s absolutely no need for a new opioid formulation.
SULLIVAN: FDA’s own advisory panels seem to agree. The panel voted 11-to-2 not to approve the drug. Then in November, top FDA officials overruled that panel. And that’s where things get complicated. Last fall, a series of emails were made public from a Freedom of Information Act request. They were emails between two professors who had, for a decade, organized private meetings between FDA officials and drug companies who make pain medicine. The drug companies pay the professors thousands of dollars to attend.
Corrupt or not, this just seems really hard to justify.
Keith Humphreys last Fall:
Yet 24 hours later, the FDA overruled its own expert panel and approved Zohydro, a pure hydrocodone pain medication that is 5 to 10 times more potent than Vicodin. In the process, FDA also overturned a precedent it had set only six months ago to not approve easily abused-opioids. After refusing in April to approve generic oxycontin because it lacked abuse-resistant properties, the FDA approved a drug whosefull potency can be instantly released merely by crushing it or dropping it into alcohol (Get ready for a rash of Zohydro-cocktail deaths).
What the country needs on prescription opioids is carefully designed, balanced and consistent policy. What we are getting is policy that contradicts itself month-to-month and even day-to-day.
And how can I not conclude with this: