Drug Diversion and Abuse: The FDA and Politicians: The Zohydro ER Debate

Cmdr John Burke
Published Online: Wednesday, May 14, 2014
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Even though the FDA approved Zohydro ER, politicians have either banned the drug on the state level through executive order or introduced legislation to do so.
Before I begin this column, I need to provide the disclosure that I sit on the Safe Use Advisory Board for Zogenix, the maker of Zohydro ER. I was chosen for this board to help advise Zogenix on how to prevent diversion when the company can, and how to deal with it if and when it occurs.

That being said, as I write this some incredible things are happening and being reported in the news that I believe are unprecedented. Even though the FDA approved Zohydro ER, a CII extended-release hydrocodone-only product with no current abuse-resistant properties, a few politicians have decided to either ban the drug in their state through executive order or to introduce legislation to do the same. All of this is being done for a drug that has barely been in the marketplace for 30 days.

The FDA has been pressured by some to change its decision and not allow this drug to be available for medicinal use. This doesn’t appear likely to happen, as my guess is that the FDA did not come to this decision over a long weekend, but rather listened to a whole host of folks and reviewed data to decide that the benefit to patients outweighs the potential risks.

However, average citizens who have been listening to the rhetoric don’t have a clue that 85% to 90% of this drug will go to legitimate patients, not drug seekers! That’s a rough estimate of the abuse level of pharmaceuticals. Once again, we have forgotten the pain patient—the patient who might not tolerate or get maximum relief from existing pain relievers and who can’t take multiple immediate-release hydrocodone doses because of the danger of acetaminophen levels.

Others, including some in law enforcement, are predicting that this drug will only add to the addiction and overdose deaths we are seeing currently. This means, if I understand it correctly, that there are a significant number of non-addicted people out there who have just been waiting for a drug like this to come to market so that they can start a life of misery and potential overdose death! That’s laughable at best, since those who will abuse Zohydro ER are already addicted to other opiate painkillers and/or heroin, not brand-new converts to the world of addiction due to a new drug being launched. Give me a break!

Perhaps what I find most worrisome is that if this continues and this drug, or the next one, is banned from certain states, or the nation, then why do we need an FDA? Politicians can decide whether any prescription or OTC drug is approved for use in our nation. They enjoy single-digit approval ratings most of the time, and most of them are lawyers, not scientists, medical doctors, pharmacists, or other health professionals. The public has to decide which of these entities they want making health decisions for them. I will choose the FDA every time, thank you.

The words that come to me when I think of this situation are “slippery slope.” It’s a common adage that can be used when someone, like me, is worried that if an FDA-approved drug, with no abuse level since it was launched only a month ago, will be denied to pain patients due to politics. The FDA was formed for a reason and typically is stocked with experts in the field to make decisions that protect us from consuming a product that would be harmful. I may not always agree with the FDA, but I accept its decisions and feel that the agency is truly trying to do the right thing to protect our citizens.

On another note, the FDA has refused to make marijuana a prescription drug, although it has approved at least 1 drug with tetrahydrocannabinol and likely will approve at least a couple more. Meanwhile, the Department of Justice has decided not only to turn a blind eye to prosecuting for current federal statutes but also to allow banking institutions to handle this currency, which by federal law is ill gotten. Once again, politicians have apparently decided that they know better and that the FDA is not relevant when it comes to deciding whether marijuana has medicinal purposes.

Finally, how do you ban a substance that has zero abuse history in its 30+ days of existence, but not move to ban the generic oxycodone IR 30 mg that has wreaked havoc in our country? I am not advocating for that ban, but I think it highlights the slippery slope problem all too well.

Note: After this article was written, a federal judge sided with Zogenix and dismissed the ban on Zohydro ER.


Cmdr Burke is a 40-year veteran of law enforcement and the current president of the National Association of Drug Diversion Investigators. He can be reached by e-mail at burke@choice.net or burke@naddi.org or via the website www.rxdiversion.com.


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