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Opana ER and the Failure of the Tamper-Proof Drug Model

The FDA pushed for tamper-proof opioids. Now it wants one of them off the market.

The Food and Drug Administration announced yesterday that it wants Endo Pharmaceuticals to take Opana ER, a tamper-proof, extended-release opioid medication, off the market.

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement released Thursday. "When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market."

It is a good thing Woodcock mentioned unintended consequences. Starting around 2010, pharmaceutical companies in the U.S. at the FDA's behest began releasing versions of their opioid drugs that users could not easily crush and then snort or inject. Back in the halcyon days of the opioid crisis, when more Americans were dying of car accidents than overdoses, crushing and snorting opioids was the most popular way to use them illicitly.

Introducing tamper-proofing was at the time considered a huge public health victory. "Some of the most widely abused drugs, including OxyContin, have been re-engineered in tamper-resistant formulations and introduced in place of their original versions," wrote former Sen. Tom Coburn and Scott Gottlieb, now the head of the FDA, in a 2012 post for the American Enterprise Institute. "Rates of abuse have fallen sharply as a consequence."

But while Gottlieb and Coburn were heralding tamper-proof formulations as a way to curtail non-medical use of opioids, users were busy figuring out other ways to get high. Some people simply chewed the tamper-proof pills. Some people figured out how to cook and inject them. Many people turned to heroin, which was suddenly cheaper than the newly patented tamper-proof formulations.

In 2015, researchers at the University of Toronto and Women's College Hospital in Toronto released findings that the tamper-proof model has not, and likely will not, solve the opioid problem. Yes, fewer patients were overdosing on tamper-proof medications, but "growing epidemiologic evidence shows that the introduction of tamper-resistant formulations has not lowered the rates of opioid-related deaths at a population level."

Why? Researchers found "increasing evidence that individuals shift to other opioids, including uncontrolled formulations such as heroin, when availability of prescription opioids changes."

(You don't need to read a study to know this. The internet is rich with first-person accounts from pill users, who--frustrated by the new formulations or cut off from their prescription by fearful doctors--turned to heroin.)

In the case of Opana ER, a tamper-proof version of which Endo brought to market in 2012, users who had previously snorted the drug took to injecting it. This phenomenon led to the largest HIV outbreak in Indiana's history, which then-Gov. Mike Pence initially addressed by praying.

That HIV outbreak, and related cases of Hepatitis C, are likely part of the "serious disease outbreak" Woodcock referenced in the FDA's press release. Left unmentioned is the likelihood that tamper-proofing has played a large role in the increased importation of fentanyl, a drug that is not just deadlier than heroin, but far deadlier than the crushable opioids that kicked off this current public health crisis.

Endo has the option to voluntarily remove Opana ER from the market. If the company declines, the FDA "intends to take steps to formally require its removal by withdrawing approval."

Until that happens, the FDA says it "is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product."

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  • Diane Reynolds (Paul.)||

    This phenomenon led to the largest HIV outbreak in Indiana's history, which then-Gov. Mike Pence initially addressed by praying.

    Riggs, you deride this as if the normal government solutions were superior.

  • BestUsedCarSales||

    I wrote Pence a letter asking if he'd change HIV back to GRID. No dice though.

  • Principal Spittle||

    The off hand slight is all the more telling because it stands alone, unaccompanied by details of the equally useless and more costly measures undertaken to combat the disease outbreaks.

    Also somewhat disingenuous to frame his statement as invoking prayer to solve the problem not as a description of his personal deliberation processes.

  • Eman||

    Janet Woodcock sure sounds like someone to be taken seriously.

  • Homple||

    You can blame government policies for HIV outbreaks and drug overdoses. Or, you can take a libertarian-sounding approach by advocating personal agency, free will plus individual responsibility and just leave that shit alone.

  • Scarecrow Repair & Chippering||

    You mean government actions have no consequences?

  • Homple||

    No, I mean loading your body with dubious stuff that could be fatal has consequences. Leave that shit alone,

  • afk05||

    I'm all for libertarian solutions and free will, but when some opiates are so addictive that they change the brains neuroplasticty, and you are dealing with dependence and addiction, it's not as simple as free will orjust don't use it. Many people got hooked for real acute pain that doctors prescribed opiates for. Blame Purdue pharmacy for lying to doctors about how addictive Oxy is and promoting a drug off label that was only approved for terminal cancer and creating an opioid epidemic in the first place.

    Solving the problem involves decriminalizing, therapy, education, prevention and research into why some people become addicted and others don't, and the very close relationship between physical and psychological pain. Pain is both neurological and psychological, and mental health isn't just about depression and schizophrenia. Stress and apathy/hopelessness both kill most people very slowly.

  • afk05||

    Purdue pharma. God damnit why can't reason have an edit function on their forums.

  • Homple||

    Suddenly it is a libertarian thing to have taxpayers fund ameliorating the consequences of people's choices.

  • ThomasD||

    "...they change the brains neuroplasticty..."

    They change the brain's ability to change.

    Okay. Whatever you think that means, it doesn't actually mean anything.

    " it's not as simple as free will"

    Horse.Shit.

    It always starts with denying individual agency. That you do it for what you think to be compassionate reasons does not make it any less morally repugnant.

  • C. S. P. Schofield||

    "it's not as simple as free will orjust don't use it. "

    But it is just as simple as "We tried outlawing this shit, and have nearly a century of evidence that Prohibitionism doesn't work. Time to get the government the hell out of the loop."

    Seriously; a Government that feels it has the right to tell you not to take opiates will also feel it has the right to tell you not to smoke, or eat trans-fats, or consume 'to much' salt. And eventually, it will tell you who you may bed, what God you may worship, and what Government programs you may protest (none).

    An addict dying of an overdose it a tragedy. The government trying to PREVENT that is a slow motion train wreck. It needs to stop.

  • Berserkerscientist||

    You don't know what you are talking about. I've taken almost all types of opioids, legally, due to my chronic disease. This includes a week of taking 10mg of morphine every 2 hours. I'm not an addict. And that is because addiction is about the person, not the product.

    The point is opioids are no more addictive than any other narcotic out there. And addicts will always find a way to mess themselves up. But making opioids illegal has been an absolute disaster. Everything is cut with street fentanyl now, and the naloxone kits are giving addicts a false sense of security.

    Frankly, if someone wants to take percocet for the rest of their life, I'd much rather they do it under a doctors supervision, than on the street. And yet the street is where most doctors will send you if they get a whiff of addiction on you.

  • Jerryskids||

    Researchers found "increasing evidence that individuals shift to other opioids, including uncontrolled formulations such as heroin, when availability of prescription opioids changes."

    Huh. So opioid addiction is so bad users will turn to illegal and risky sources rather than abandon their addiction if they can't get a legal fix? Who could have guessed that, given the past successes of alcohol and narcotics prohibition?

  • Don't look at me.||

    "It's different this time" , or something.

  • LarryA||

    "Right people in charge."

  • Longtobefree||

    We are winning the war on drugs.
    The casualty rate is higher than we expected, but we are winning. Please send more money.

  • Hank Phillips||

    The same thing was tried in the sixties. Pharma companies were forced to add cornstarch to buffer so attempts to sterilize by boiling ruined the procedure. So boiling was dispensed with, clean needles made illegal and HELOOOO hepatitis and AIDS epidemics in exactly those brilliant jurisdictions. Competition makes things cheaper, and no way can stupefacient drugs compete with smartifacient psychedelics in a legal market.

  • Bradley Strider||

    Fentanyl has led to far worse public health problems (overdoses, etc) than the synthetic opioids it replaced.

    And its rise is entirely thanks to government interdiction efforts. They never fucking learn.

  • Homple||

    "And its rise is entirely thanks to government interdiction efforts. They never fucking learn."

    And neither do the people who kill themselves lapping up the worse shit that shows up after every government crackdown cycle. The users never fucking learn.

  • Berserkerscientist||

    Do you think people are dying of prescription fentanyl? I've taken prescription fentanyl. What you are talking about is STREET fentanyl, crap made in Chinese labs, cut with a bunch of unknown garbage. Of course that sh!t will kill people, not only because of its unknown formulation, but unknown dosage.

  • ThomasD||

    The problem with street fentanyl isn't the garbage, the problem is the fentanyl. Street fentanyl is the real deal.

    The problem is that fentanyl is an extremely powerful narcotic. Unless you have a scale that can accurately measure doses in micrograms you cannot measure doses safely.

  • Eman||

    Its hard to imagine something to cut fentanyl with that would make it more dangerous.

  • ThomasD||

    Sufentanil and carfentanil, both being substantially more potent than fentanyl, come to mind. And there have been some fears of them making their way into the street drug melange, but I haven't seen any actual laboratory confirmation .

    Frankly, any clandestine lab operators that think those agents are viable sources of revenue are insane. How much profit is there to be made by killing your customers?

  • jennyhannb||

    "When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market." skype login

  • Eman||

    Snorting painkillers hurts. I hear.

  • therealdoer||

    the Look out figures

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