A Response to Zogenix Inc. on Zohydro

I received an email today from David Polk, who is a representative for Zogenix, Inc., the company that manufactures Zohydro, the controversial new hydrocodone pill recently approved by the FDA.

David was upset about my story “Mexico Trades Marijuana for Heroin”, where I detail the rising abuse of heroin in the United States and trace it to the DEA’s approval of massive increases in drug company manufacturing quotas for synthetic opioids. Particularly, David was upset I brought Zohydro into the discussion in the final paragraph. David wrote:

Russ Belville’s story, “Mexico Trades Marijuana for Heroin” inaccurately reported that Zohydro ER contains “five times the hydrocodone available in Vicodin”. That’s simply not true and is just another unfortunate example of the misinformation that continues to be repeated in news stories across the country.

In terms of hydrocodone potency, a 10 mg dose Zohydro ER is the exact same potency as a 10 mg dose of Vicodin or any other hydrocodone product. And contrary to what has been reported, Zohydro ER is not the most powerful opioid in its class. Many marketed opioids are more potent, including oxymorphone, methadone, hydromorphone and fentanyl.

I’m sure you agree that High Times readers deserve the facts and I hope you will correct the story to reflect accurate information about Zohydro ER.

David, thank you for your concerns. I always strive to be accurate, but I’m no pharmacologist, so I must rely on what people far more trained than I have been reporting about Zohydro. Let’s cover “some accurate information about Zohydro ER” that you’re conveniently glossing over.

CBS News on April 4 (http://www.cbsnews.com/news/states-try-to-block-new-powerful-painkiller-zohydro/) reported “States try to block new powerful painkiller Zohydro”. In that report, I found the statement:

…an extended-release capsule that contains up to five times the amount of narcotic hydrocodone previously available in pills.

This article also informed me that Zohydro is formulated with hydrocodone, like Vicodin, yet contains none of Vicodin’s acetaminophen. I also learned Zohydro is not yet formulated with anti-abuse properties that were mandated for Vicodin and Oxycontin to prevent users from crushing and snorting or injecting it.

Furthermore, in my research I learned that the FDA approved Zohydro despite an 11-2 vote against it by an FDA advisory panel. I followed up by finding this February 27 article in WebMD (http://www.webmd.com/pain-management/news/20140226/new-painkiller-zohydro-criticized) “Critics Oppose FDA Approval of Painkiller Zohydro”, which stated:

Critics of the FDA’s ruling include attorneys general from 28 states and FED UP!, a union of consumer groups, addiction treatment providers, drug and alcohol prevention programs, and other interested groups.

So, it seems I’m not the only one raising a red flag here. As for your contention that a 10mg dose of Zohydro equals a 10mg dose of Vicodin, perhaps that is true, given the same active ingredient of hydrocodone. However, according to Vicodin.com, the manufacturer’s website:

VICODIN® 5 mg/300 mg, VICODIN ES® 7.5 mg/300 mg, VICODIN HP® 10 mg/300 mg, VICODIN® 5 mg/500 mg, VICODIN ES® 7.5 mg/750 mg, and VICODIN HP® 10 mg/660 mg (hydrocodone bitartrate and acetaminophen tablets, USP) tablets are indicated for the relief of moderate to moderately severe pain.

In those descriptions (confirmed on the National Institute of Health website) I learned Vicodin is available in 5mg, 7.5mg, and 10mg dosages, with between 300mg – 750mg of acetaminophen that isn’t contained in Zohydro. Now, when I read further on Zohydro on WebMD (confirmed also on the National Institutes of Health website)…

It will be available in doses as high as 50 milligrams per pill — five times the amount in immediate-release hydrocodone pills.

The discussion continues, explaining how Zohydro is the first hydrocodone available without acetaminophen or ibuprofen. Zogenix Inc. is promoting that fact due to the hepatotoxicity of acetaminophen, so pain patients with liver failure can use it. But one addictions expert cites the knowledge of possible liver failure from continued abuse of Vicodin is one of the deterrents to prolonged addiction and points out there are many other non-hepatotoxic pain reliever alternatives out there (we’d be remiss not to mention cannabis).

And marketing a pill with 50mg of hydrocodone in it – ten times the standard 5mg dose and five times the strongest 10mg dose of Vicodin – is going to kill people. As Dr. Andrew Kolodny of the drug addiction clinic Phoenix House, explained to CBS News:

“Many people are concerned that, as soon as this drug hits the market, many people will die from it. A child who’s never taken an opioid before could die from taking just one capsule, and an adult who’s not used to taking opioids could overdose on just two capsules.”

So, yeah, your Johnny Walker Red may be the same proof as their Jack Daniels, but they’re serving it to alcoholics in a shot glass with a Coke back and you’re serving it in an eight ounce glass, neat.

Nice try, David. I understand how hard you must have to be spinning to get the American public to accept another dangerous addictive opioid when the United States already consumes 99 percent of the world’s hydrocodone and 83 percent of its oxycodone and we’re in the midst of a rising heroin overdose epidemic. It also must be terribly maddening to pharmaceutical company shareholders everywhere, Zogenix included, that medical marijuana keeps passing in state after state when a survey of California’s Berkeley Patients Group, confirmed by anecdotes I hear from patients coast to coast, showed that patients using medical marijuana were able to seriously reduce or eliminate their need for opioid painkillers.

I’m not changing a thing about the article – “five times the hydrocodone available in Vicodin” is accurate when the greatest “available” amount in Vicodin is 10mg and the greatest “available” amount in Zohydro is 50mg.