Panel recommends FDA approve implant to treat opiate addiction

[Z]

http://www.usatoday.com/story/news/2016/01/12/implant-aims-help-addicts-stop-using-heroin-prescription-painkillers/78677618/
An advisory committee recommended Tuesday that the Food and Drug Administration (FDA) approve an implant designed to reduce addicts' cravings for heroin or prescription painkillers.
The implant, probuphine, provides a steady dose of buprenorphine, which has been shown to ease withdrawal symptoms, decrease cravings and cut the risk of relapse. Buprenorphine is currently available only as a pill or dissolvable film that's placed under the tongue. Although it can be life-saving, it carries major risks: some addicts sell their supplies to get money for other drugs.
Probuphine's manufacturer, New Jersey-based Braeburn Pharmaceuticals, says the implant eliminates that risk. The FDA typically follows committees' advice.
Probuphine's development comes at a time when addiction to opiates — which include illegal drugs such as heroin, as well as prescription painkillers such as morphine and OxyContin — has been called an epidemic.
The death rate from drug overdoses more than doubled from 1999 to 2013, according to the Centers for Disease Control and Prevention. Drug overdoses now kill 44,000 Americans a year – more than car accidents.
At the advisory panel's meeting Tuesday, several witnesses described how opiate addiction has harmed them or their families. Two fathers described how their sons died from drug overdoses, and both asked the committee to recommend approving probuphine.
Medications to treat addiction are strictly regulated.
Methadone is available only at specialized clinics, where patients typically must go every day to receive a dose. Buprenorphine is considered safer than methadone because it's less likely to cause an overdose. Patients can receive buprenorphine at a doctor's office, but physicians prescribing the drug must be certified to dispense it and are only allowed to treat 100 patients at a time.
Like all pills, buprenorphine can be accidentally swallowed by children. About 1 million people took buprenorphine in 2012, according to the FDA.
The White House has recommended expanding the use of medications that treat opiate addiction. Addicts who are given such "medication-assisted treatment" cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration. The medications also halve a person's risk of becoming infected with HIV, the virus that causes AIDS.

Probuphine works like a contraceptive implant, such as Norplant. Four implanted rods, each smaller than a match stick, provide a steady amount of medication for up to 6 months. The FDA is considering approving it for a specific population: "stable" patients who are already taking the dissolvable buprenorphine film at a low dose. The committee voted 12-5 in favor of probuphine.
"I think this will save some folks' lives," said advisory committee member David Pickar, an adjunct professor of psychiatry at Johns Hopkins Medical School in Baltimore.
Doctors who want to prescribe probuphine would have to refer patients to providers trained to implant medical devices, or undergo training to learn how to safely implant and remove it, said Behshad Sheldon, president and CEO of Braeburn Pharmaceuticals, who spoke at Tuesday's advisory committee hearing.Implanting probuphine takes 10 to 15 minutes and removing it takes about 20 minutes, said Steven Chavoustie, a physician involved in a clinical trial of the device.
Pharmacist Tracy Rupp urged the committee to reject probuphine, noting that its manufacturer presented only one clinical study showing the drug was effective.
In the study, doctors compared the use of probuphine implants and buprenorphine film, Sheldon said. Patients in the study were considered "stable" because they had been safely using the films. After 6 months, 85% of those given probuphine tested negative for illegal drugs, compared to 72% of those given the film.
The study had multiple flaws, said Rupp, director of public health policy initiatives at the National Center for Health Research, a nonpartisan group that analyzes health data.
Some missing urine tests were counted as negative, as if the patient had no drugs in their system. But Rupp noted that people addicted to opiates "often skip tests to avoid a positive test." That could skew the results, Rupp said.
"It is disappointing that the advisory committee set such a low bar for safety and effectiveness," Rupp said after the vote. "Is probuphine effective? We still don't know because the study was poorly designed and missing data."
Judith Kramer, the committee's acting chairwoman, said she voted against recommending probuphine's approval because doctors don't yet know if it's effective for more than 6 months. Many people who are addicted to opiates need to take medication for years, she added.
"We all desperately want something to be available" to treat opiate addiction, said Kramer, a professor emerita at Duke University in Durham, N.C. Yet she added: "I’m very concerned about the precedent this sets."
Some addiction specialists say they're concerned about probuphine's safety.
Doctors don't yet know how to safely transition patients from buprenorphine films to the implant, said pharmacist Tracy Rupp, director of public health policy initiatives at the National Center for Health Research, a nonpartisan group that analyzes health data.
Rupp, who recommended the committee reject probuphine, said it takes up to four weeks for the implant to provide the same level of medication provided by the film strips. That suggests patients will need to continue taking buprenorphine by mouth for the first few weeks after receiving the implant, Rupp said. Rupp said she's worried patients could relapse during that transition. "This is an unacceptable risk for stable patients," Rupp said. Rupp also said the study didn't match the demographics of addicts in real life, noting 84% of the patients in the study were white. Jennifer Higgins, the committee's acting consumer representative, said she would like the FDA to require studies in more diverse populations. [/color]"This is not the real world of opioid addiction," Rupp said. "Many of these patients will require treatment for years. We need long-term safety data from diverse populations. Patients will require a new incision every 6 months, creating an ongoing risk of harm due to bleeding and infectious complications."[/size]

[sk8phaze]

I saw this a while back. Not a chance in hell im getting that thing implanted in my azz. Lol. I stick to my strips.

[corlene]

They had a couple of places down here participating in the clinical trial of this, or something very similar, paid decent for 6 months and almost double for 12. I don't remember the exact number, but segall institute in miami was part of it, was on billboards and such

[sk8phaze]

 I remember a pain doctor in Florida speaking out against this because junkies dig under their skin with needles all the time and They worry about having 6 to 12 months of drugs out on the street all at one time (if the implant was removed)

[St. Theresa]

I remember a pain doctor in Florida speaking out against this because junkies dig under their skin with needles all the time and They worry about having 6 to 12 months of drugs out on the street all at one time (if the implant was removed)

Lol I have a hard time picturing our brethren being desperate enough to line up just to get some freshly extracted bupe from another junkies body.

[theSWPK]

I think it's a good idea, but I do have some reservations about it, mainly just the fact that it's an implant. I'm not wild, and never have been, about the idea of have doctors put medication in your body that you can't remove yourself.

I understand, and can relate to those that require a solution to addiction that can't be bypassed such as an implant. There's a lot of addicts that lack the discipline required to stick to their maintenance med.

I think this is a MUCH better alternative to naltrexone shots/implants. While vivitrol is an awesome idea to keep people from fucking their sobriety up, it can make some people feel like total shit by blocking endorphine receptor sites, so it's good that there's an alternative.

One thing that seemed kind of off is that the group eligible for this implant in the study was comprised of those who had not deviated from their bupe plan and had repeat clean urine screens. It just seems like it would be better for those that had trouble sticking to the bupe.

[Z]

I wondered if this is what Shelley had gotten back when?  I remember her posting her horror stories, but I don't remember what the implant was exactly.

[sk8phaze]

Lol I have a hard time picturing our brethren being desperate enough to line up just to get some freshly extracted bupe from another junkies body.

Yeah getting sum Bupe that's been dug out of sum junkys arm doesn't sound like anything id ever buy. This dude Alex i used to know would wake up and do a very potent speedball every morning and inject 2/3 of the mix and then give his used needle with his blood still in it to his dope sick friends and call it a bloodshot. Talk about the opposite of harm reduction...

[corlene]

As opposed to giving whoever 1/3 of the dope before it was full of his blood? I'm sure people freely shot that too. Sick world

[Narkotikon]

God, aside from only taking 8mg instead of the full 16mg, I'd be considered one of those stable patients. No way in hell would I accept this for treatment.

Aside from all the valid points the article gave, which I agree with, I don't like not being able to save my extra dose. I'm responsible enough. I'm not selling this shit, or even trading Subs. They pretty much suck for getting high, especially if you've got a tolerance to full agonists.

I save half my dose because I worry about what would happen if I lost my insurance. I'd be fucked. I therefore save half my dose as an insurance policy. You can't do that with the implant. Not that doctors consider saving and stockpiling an acceptable practice anyway.

Plus I don't like the fact that it stays in so long. I think too many addicts would think about extracting the implant themselves in order to get high on opiates. Or it would make it more likely that they'd relapse on other drugs like coke.

With the current Subs they can easily choose to stop taking it and a few days later they're good to go. Even only one day if they're taking low doses like 2mg. People can push through that blockade. Doesn't really apply to polydrug users, but it would to straight opiate addicts.

[Thoms]

I like the option, the way I see it the more options we have the better. Would it be for everyone? Nope.. Would it be for me? Perhaps... It's hard to say but the more options availabe the better.

[Guts]

How can you trust this little machine is doling out medicine evenly for an entire year? Are these little shits that good? I mean I really just don't know and am asking... I could only imagine it running out two weeks early and your doctor not believing you because, well, you're basically sub-human and all.

[Narkotikon]

How can you trust this little machine is doling out medicine evenly for an entire year? Are these little shits that good? I mean I really just don't know and am asking... I could only imagine it running out two weeks early and your doctor not believing you because, well, you're basically sub-human and all.

If it ran out or malfunctioned, the doctor would just do a withdrawal check. Opiate withdrawal has a list of classic, very specific symptoms. We know them all too well, wonderful as they are. Doctors do too.

Some symptoms are early onset. Things like yawning. There's a whole scale from early to late / severe. The doctor would just use the checklist to determine that the patient was in withdrawal.

That is IF the doctor is worth his salt. I was in a psych ward on a forced 72 hour hold when I was 27, and the doctor didn't seem to know much about opiate withdrawal, and the nurses knew absolutely nothing. I kept asking for ibuprofen, and the one nurse asked why I needed it so often. I told her my legs hurt. She then asked why my legs were hurting. I looked at her with this amazed, stunned look, and said because I'm in opiate withdrawal. She obviously had no idea.

Such a horrible psych ward experience. All I got was a measly 0.1 Clonidine TID, 200mg ibuprofen (they wouldn't give me more than that each time), and a 25mg Vistaril at night (not that that helped much). And I even had to ask the doctor for the Clonidine. Not that that helped much either. I'm not a Clonidine fan for withdrawal.

Then where did the place send me to when I was discharged? Fucking Teen Challenge, which is some bullshit, overtly Christian "rehab." When I was given the tour, I passed by a group therapy room and one of the patients was singing some crappy Christian song and banging on a Star of David shaped tambourine. They call that therapy. It's shocking people choose to go there and actually pay for it.

Luckily, and I use that term very loosely (I can't stress that enough), I was told by the admissions guy I couldn't stay because I was gay. So my sexuality got me out of that shit show. Don't worry, not before he gave me some offensive stereotypes and told me I couldn't stay because I couldn't be trusted in a communal environment of only men. Please (major eye roll, and I can't stress that enough). I highly doubt I'd wanna hookup with any of those people. And even if I did there's such a thing as self control. He acted like I was going to rape someone. Sorry, not that type of guy. In short, I've NEVER been so offended for being gay.

And where did I end up in lieu of Teen Challenge? The fucking Salvation Army rehab. That's an even longer story. Again, not a rehab! More like forced labor sorting donated clothes. That's their "work therapy." I did five days there. And that entire time I got one hour of actual substance abuse treatment. And that was in group therapy. Not individual.

Fortunately after five days I was allowed to come home. I refuse to ever go through that experience again. I'd rather live in my car.

[Z]

I can understand the appeal of having the benefits of a maintenance med without the drawbacks of having to take it every day, forgetting the meds somewhere, or running out somehow.  I think it has a lot of potential, but like the article says there are a lot of drawbacks.  From researching a minute it looks like you can get them removed whenever you want, but it could leave scars and is a big thing.  Then again, removing them at the end has the same risks.


I remember reading that the birth control implants don't deliver a steady dosage.  They tend to start out at a higher then desired rate, and with time they drop down to a level that is lower then desired.  I assume the theory is that the transition is slow enough that your body adapts to the new dosage.  I assume that the risk is minimal.


I could see these being popular with drug courts. No chance whatsoever to get high, or do anything like skip doses to be able to get high.  That is their dream drug for being a tol of social control, right?


I could see this being very dangerous from the perspective of someone using a massive dose to try to get over the implant.  The other thing would be having someone try to take out all 6 implants themself because they don't have the money to pay someone to take them out.  It raises an awkward point in my eyes.

[Sand and Water]

Narks points about a "rainy day" scenario really hit home for me. My immediate thought was that no procedure is 100% without flaw/errors. So, lets say ya get this & it doesn't work?  How long will it take to get seen & verify & a scrip? What if insurance "fights" it & no $$ to self-pay? 

Not trying to be negative & I really hope to hear good things about it (can see the benefits for sure), but i learned long ago to wait a few years when a new drug or procedure comes out b/c there's almost always things they learn later. I *still* remember being SO excited about the artificial spinal disks--turned out an engineering error caused way too much pressure on the "good" disks above & below the replacements. Those folks are screwed for life.