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In October of this year the FDA approved Zohydro ER (extended release), a pure hydrocodone product with close to 10 times the amount of heroin-like narcotic found in traditional hydrocodone products. The product has been approved in its current slow-release formulation, meaning that it can be crushed, chewed or mixed with alcohol and still retain full potency. Drugs like OxyContin have been formulated in a way that decreases the power of the drug when altered from its original form.

There are several troubling issues about the drug, Zohydro, starting with the approval process by the FDA. Andrew Kolodny, a physician and the chief medical officer of Phoenix House, which runs drug and alcohol treatment centers in 10 states, has fought for stronger restrictions on pain-pill prescriptions. He attended the recent public meeting and spoke during the public comment period. “One has to wonder how many more pain patients have to be harmed, how many more people have to become addicted, how many more lives will have to be lost,” he said, “before the F.D.A. finally begins to exercise its authority and responsibility to prohibit drug companies from marketing opioids as if they have been proven safe and effective for long-term use.”

The issue is a complex one; it is not a simple matter to withhold drug approval when similar drugs have FDA approval. Zohydro has been ruled to be as safe and as effective as other drugs in the same class. The real conversation should be focused on the whole class of painkillers. But as Bob Rappaport, the director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, points out, “We are obligated at the agency to operate within the regulatory framework,” he said, “and that includes providing a level playing field for industry. We don’t have a choice by that. It’s the law.” (The New Yorker, 12/3/13)

The other troubling issue with this new drug is the close association of the manufacturer, Alkermes, and the American Society of Addition Medicine. Alkermes also makes Vivitrol, a popular drug for the treatment of people addicted to painkillers or alcohol. Alkermes appears to have close ties to experts in the field of substance abuse, and is a financial contributor to the American Society of Addiction Medicine. So, we have a pharmaceutical company that makes highly addictive drugs making financial contributions to an association of substance abuse experts.   Does this sound like, at a minimum, the appearance of a conflict of interest?  Is this a closed-door alliance to maintain addictive behaviors? Is there a logical reason for Alkermes to give money to this specific group? And, how does that affect its  judgment when it comes to manufacturing a extremely potent and high-addictive medication?  You can answer the questions easily.  It smells a little funny.

The FDA approved this drug even after its own approval panel voted, 11 to 2, against approval. And, now Attorneys General from 28 states have written a letter asking that the FDA either “reconsiders its approval of Zohydro ER, or sets a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies to impose restrictions on how Zohydro ER can be marketed and prescribed.”

One does not have to be a physician or pharmacist to see that Zohydro ER is a very powerful,  dangerous drug.  Did the FDA act too quickly? It certainly acted against the recommendation of its own panel of experts, which is somewhat puzzling.   Why is this powerful of a drug needed?  Are the current drugs we have insufficient?  It is hard to imagine that our physicians do not have a sufficient selection of narcotic pain medications from which to choose.   Perhaps this is another block-buster, high profit-margin drug for the manufacturer.

How frequently will doctors prescribe this medication? “In 2011, U.S. doctors wrote more than 131 million prescriptions for hydrocodone, making it the most prescribed drug in the country, according to government figures. Hydrocodone also consistently ranks among most-abused medicines in the U.S., according to the Drug Enforcement Administration.” Only time will tell how this drug will be received and how much it will be abused.  Hopefully, it does not follow a similar path of its little sister, hydrocodone.



  1. Gravatar for Jolie Cosette

    Good. Now I no longer have to worry about Tylenol destroying my liver. MS and metastatic breast cancer have destroyed almost everything else.

  2. Gravatar for M Smith

    You act like the conflict of interest is a new thing? Have you noticed that subutex generics are made by Roxanne, Mallinckrodt, Actavis, as well as other opioid power-houses? Subutex/suboxone(buprenorphine: naloxone is just in there to control & extend the patent by Reckett Benckiser) are addiction treatment drugs. Patented way before your example, it seems as if you're a bit late to the party. It's all about money; I don't know why I even bother to bring this up, but that's the reason THC is schedule I, when its known to work alot better, and more importantly, safer, than alot of the pills at the pharmacy. Why do you think this conflict of interests was approved? Lobbyists; the same reason any and all corruption goes on. Get rid of them, get rid of corruption. It really is that simple.

  3. Gravatar for M Smith

    Didnt see the comment above mine. That's very true. Although this may increase addiction, it definitely will decrease pain-related overdoses. Nobody taking the Vicodin/lortab as prescribed has ever died from hydrocodone(minus allergic reactions). Every hospital or morgue visit is acetaminophen/paracetamol-related. You'll die of Tylenol(95% of the Vicodin's composition) before you'll die of hydrocodone(5% composition). To logical people, this is a lot safer to your physical well-being than Vicodin could ever dream of being.

    But, instead of getting rid of the Tylenol, like any caring FDA would, they'd rather take money for a new company to enter the field with a drug that's essentially just Vicodin minus the liver-toxicity. Once again, lobbyists. In this case, everybody wins, in a way of sorts. Usually, only big pharma wins. This is the new oxycontin, but it's corporate greed that led to OC being OPointless. Ineffective gel/rubber cement VS a pill that actually will dissolve and have effect. It's a win win win

  4. Gravatar for

    The FDA required the makers of Oxycontin and Opana ER to develop tamper resistant technologies ,I am very surprised that this was not required for a medication that contains hydrocodone, the most abused prescription pain medication in the country. This addition to painkillers makes no sense.

  5. Gravatar for Tim Basta

    Something needs to give. We either have to treat pain or preclude addictive behavior. If pain is effectively treated, there is always the potential for abuse of the drugs. So what should society emphasize?

    I have a chronic pain condition and opiates help — help to the degree that when I have a flair-up of pain, the only way I can function and do things like cook food or clean myself is with pain medication. I've used them as needed for more than six years now and have no desire to abuse them. The other side- effects of taking opioids are uncomfortable enough that I really don't have any pleasure using them. More a sense of desperation.

    Why have multiple types of opiates? Because they all have different side effects. Each are based on different aspects of opiate medication. Some people can use one type and others have to use a different opiate because the side-effects vary as well as each medication's effectiveness.

  6. Gravatar for WTF

    I think said it well. Why is Zogenix receiving preferential treatment from the FDA? Why did the FDA not side with their own panel? This drug appears to be in capsule form, which you simply open and pour out powder ( I hope I'm wrong and it's not that easy). More worrisome are those 50 mg pills. I would imagine there is significantly less powder in the zohydro capsules as compared to the original OxyContin in tablet form. Point being the purity of this powder is like nothing we have seen. Ask a heroin addict, would you rather have 10 mgs of pure heroin or 20 mgs of 50% pure heroin and they will go with the pure every time. It is a frightening thought what this drug will do. I can empathize with chronic or palliative pain patients, however there are plenty of other opiates on the market (oxymorphone, oxycodone, hydromorphone, fentanyl to name a few). This beast should not be released until the tamper resistant version is ready for prime time. It's for the greater good.

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