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FDA Approves First Implant Treatment For Opioid Addiction (bloomberg.com)
An anonymous reader writes from a report via Bloomberg: The Food and Drug Administration cleared the first implant in the U.S. to treat heroin and opioid painkiller addictions. The product, Probuphine, may be used to treat addicts continuously for six months with the drug buprenorphine, according to a statement from the agency on Thursday. Titan Pharmaceuticals Inc. and partner Braeburn Pharmaceuticals are the two companies behind the implant and plan to bring it to the market just as Congress passed a bill aimed at addressing the opioid crisis. Buprenorphine differs from methadone in that it doesn't require a treatment program. Doctors can prescribe the implant to patients after they take a four-hour training program. The FDA rejected the implant in 2013 because the original dose that the companies proposed was too low to provide effective treatment. The companies decided to maintain the lower dose and attempt to gain approval by restricting use to patients who already were stable on such amounts. Meanwhile, employers are struggling to find workers who can pass a pre-employment drug test.
This is completely different.
In that case the pharmaceutical industry is profiting by providing a "solution" to problems caused by the tobacco industry. In this case the pharmaceutical industry is profiting by providing a "solution" to addiction problems caused by the pharmaceutical industry.
If the "solution" isn't very effective and provides on-going sales - well, that's just a lucky side-effect.
It's a maintenance program that's a little less vulnerable to diversion. This exists for naltrexone already (an antagonist).
Implanting opioids inside of people probably isn't the solution to the "opioid crisis" that you're looking for. In other news, opioid overdose deaths have fallen dramatically here since a medical marijuana program was established; might consider looking in to that, guys. You know, the drug that doesn't cause respiratory depression and can't be injected.
The idea is to replace the drug of choice with a drug that will 1) not provide a high, and 2) reduce withdrawal symptoms.
Treating nicotine addiction is a little different in that it usually means moving away from cigarettes (which contain addictive compounds other than nicotine). Gum and patches do not provide the other compounds. Gum/patches also don't inhibit getting pleasure from nicotine, so it is inferior to using a drug to reduce highs and withdrawals.
So really, this is no different than treating nicotine addiction with more nicotine (ie. gums and patches, etc).
There's a reason we don't treat alcoholics with whiskey.
Actually in some very rare cases you might do exactly that. Sudden alcohol cessation can have fatal consequences, even more dangerous than quitting opiates cold turkey.
The idea is to replace the drug of choice with a drug that will 1) not provide a high, and 2) reduce withdrawal symptoms.
Opiate addicts are a little more functional on replacements than on heroin, but this is only because they don't have to worry about how they're going to "stay well". People can be functional heroin addicts if they don't have to worry about sourcing their next dose. In Chasing the Scream, Johann Hari says that some countries give the give their opiate addicts all the heroin they need, and provide a safe, supervised environment for use. Most addicts eventually age out of their addiction.
I met a real drug addict about a year ago, but I didn't realize it at the time. She fluttered from topic to topic like a butterfly, and I said, to myself, "this woman is high as a kite..." She told me about going to the Methadone clinic every day. She gradually invited me into her world, and I learned that the methadone wasn't enough to fill the "holes in her soul". She supplemented her opiates with the street pharmacy's medicines.
With my influence, by about six months she was doing much better. She quit methadone and alcohol cold-turkey. Then the mental health system got a hold of her, and it's been a real struggle ever since.
Calling the mental health system "Psychiatric torture" is not fair to the suffering endured by people who've actually been tortured, but it precisely describes the hopelessness and futility endured by people who are "treated" with drugs that do not address any of the causes of their condition. "Psychiatric Abuse" will have to suffice.
She got addicted to anxiety medications during her fifth mental hospital stay. She'd only wanted them as-needed, but they forced her to take that pill every day. Two weeks after she was released, she hatched a stupid plan to get through the benzodiazepine withdrawal. We got together the second night of her stupid plan, and had a little fight. She said that I didn't understand that she wasn't going to get addicted again, she just needed it so she could sleep. She said it was barely any heroin at all, and just to spite me, she prepared a second shot and did that too.
When she revived, she was immediately terrified by the sudden presence of people in uniform. The firefighters should've followed protocol and taken her to the hospital, but I'd told them that she was already on court-ordered treatment, so they decided to just disappear into the night. After a few more minutes, the police decided they could leave too. The only evidence I have that anyone was there is the nebulizer used to squirt the anti-opiate drug into her nose.
She did very well for the next two weeks. But I was 2 hours away, and she was left to take care of herself, with the added burden of having to take court-ordered anti-psychotic sedatives. She was back in the mental hospital about 5 weeks after her release from the fifth mental hospital stay.
Psychiatrists must be trained to not care why their patients are in their care. They gave her a new anti-psychotic, but she was still quite delusional when she was released from her sixth mental hospitalization.
By this point I'd obtained the drug that she actually needed. It worked exactly as I thought it would, I brought her to live closer to me, and she started to recover from her anti-psychotic-induced brain trauma. Her new psychiatric nurse initially wanted her to stay on the anti-psychotic sedative, but eventually realized the patient doesn't actually need to be permanently sedated.
But she ran out of anxiety medication recently... Her new court-ordered-treatment provider said they didn't provide those drugs, so my friend went to source them from her old "friends". Street drugs are much easier to source than specific second-hand prescription medications.
Street drugs caused her to become psychotic again. She would have come out o
Buperinophine doesn't prevent you from getting high, and you can ask the users of Suboxone about that. It is still possible to get high and feel good from buperinorphine which means even if you have this implant you can still get high and abuse it by taking additional buperinorphine. In terms of stopping withdrawal symptoms,bupe does it the same way heroin does it: By activating the mu-opioid receptor. That means when it comes time to remove the implant or when the dose starts to go down, the user WILL experience opioid withdrawal symptoms. The only thing bupe and methadone do is put off the withdrawal symptoms for a later time, but you still have to go through them.
So in however many weeks or months when the implant starts to lose its effectiveness cravings will come back and the user will either need to get a new implant or deal with the cravings and withdrawal. There is absolutely no way around this (I can tell you this as someone who just finished opioid replacement therapy with methadone and then subutex and I'm going through withdrawal RIGHT NOW). Tapering is the only effective treatment in terms of alleviating withdrawal symptoms (beside from ibogaine).
No matter what, the golden rule is this: If you take an opioid to stop opioid withdrawal, you WILL eventually have to go through withdrawal. You are just putting it off for now. Buprinorphine IS AN OPIOID. The comparison between nicotine replacement therapy and opioid replacement therapy is apt. Its not getting you off the addictive substance, its getting you off the harmful method of consumption (inhalation of smoke for tobacco and injection/use of impure heroin with opioids). You still have to do the hard work of getting clean and replacing the habits you had before with new ones that aren't related to drugs.
To say that this is a treatment for addiction is absolute bullshit. This is just a maintenance drug, nothing more. It goes in the same category as Methadone and Suboxone: A drug to keep you addicted. That may sound tin-foil-hat but when you know there are more effective drugs that actually DO treat the addiction (like Ibogaine and its much safer analog, 18-methoxycoronaridine) you start to see the greed at work. Pharmaceutical companies can either make a product that cost them next to nothing, is already in use in the medical community, and provides a GUARANTEE that the patient WILL have to come back for more, its a home run. Its a license to print money. You have a drug that is highly addictive, and you are selling it to people as a way to get off some other highly addictive drug. Now lets look at 18-MC. It will cost those drug companies a good amount of money to bring it to market and they wont have a repeat customer. 18-MC, and ibogaine, have shown incredible efficacy in actually STOPPING addiction. Not calming it down, or pushing the withdrawal symptoms back, or maintaining. Ibogaine and 18-MC can full-on stop addiction right in its tracks. You stop craving, you don't have withdrawal symptoms, you are FREE of the drug. And its a single dose.
I'm rambling now so I'll just summarize by saying this. This is not an anti-addiction treatment. Its a maintenance treatment, nothing more. Its a way for pharmaceutical companies to make money while saying they are doing something about the addictive drugs they make. There exists a drug that can actually, for realsies, "cure" addiction but since it won't make as much money they won't even consider it. The only way 18-MC even got a clinical trial was because it was also an effective treatment for leishmaniasis. If it wasn't for that, it would have NEVER been given a clinical trial.
I met a real drug addict about a year ago,
I did heroin for many years. I was on methadone for years too. And now, for about 5 years, have been taking buprenorphine. There is so much written on the subject http://www.bluelight.org/vb/th..., I hesitate to add, particularly since I criticize people for tending to be long-winded on it. I currently have both Suboxone strips, for which placing under the tongue is the route of administration and Zubsolv, another formulation. I, personally, wouldn't like an implant, because you can't adjust your dose to suit the circumstances. I guess the advantage is convenience.
(||) Nehmo (||)
Just out of curiosity driven by this story and apart from getting to this very very suspicious site http://www.naabt.org/buprenorp... compared to this more realistic site http://www.streetinsider.com/C..., it seems like the drug and treatment might not be all it is cracked up to be. I'll bet before to long we will see lobbyists demanding it be compulsory for all opioid drug offenders, profit, profit, profit, you can really see it coming.
Chaos - everything, everywhere, everywhen
There's a reason we don't treat alcoholics with whiskey.
I suspect it's not a very good reason or a reason whose motivation is derived from Calvinistic moral calculus.
My friend's step mother is an alcoholic and has been through a half-dozen treatment programs, most of them in-patient programs and still hasn't stopped drinking.
What if we just acknowledged that alcoholics drink, and instead of trying to foist abstinence we instead eliminated the shame associated with "failing" to become a teetotaler and instead put some effort into just getting their drinking down to less-destructive levels?
There were at least two NYTimes articles about this kind of thing in the past year, including a Dutch program that gave chronic alcoholics jobs *and* beer, providing them with structure that got them into a productive life cycle but acknowledged that they could drink, too? From the looks of it, it appeared to be fairly successful. The key things seem to be getting into life patterns that provide meaning and teaching them to drink at levels that are much less destructive. Eliminating the shame associated with drinking seems to be important to this.
From everything I've read, psychiatrists consider buprenorphine an extremely good treatment for opioid addiction. If getting opioid addicts on a stable maintenance dose and back into constructive life habits works for them, why couldn't something similar work for alcoholics?
The relentless focus on total abstinence seems bizarre in comparison to, say, people with depression whom we *encourage* to take maintenance doses of anti-depressants without relentless shaming of those who can't "just get better" and stop taking them.
It would not surprise me at all if we ever found out that some people are biologically susceptible to alcoholism or opioid addiction due to brain chemistry imbalances, just as some people are prone to depression for the same reasons.
As much as society struggles with drug addiction, I'm surprised we haven't figured out that maybe the better solution is invent better recreational drugs. Drugs purposefully engineered to provide euphoria similar to street drugs, but engineered to limit the risks of overdose and abuse.
Could they engineer a drug that provided a high with the first dose but for which subsequent doses had an exponentially decreasing marginal utility or which couldn't be taken again for any increase or new high until some hours had passed? Some of this may just be a question of formulation, with a dose of a time-release longer-life agonist that both eventually reduced the high and blocked any new high from happening.
You can come up with a bunch of engineering goals that would allow for a person to take such drug and make abuse very difficult due to limited repeat use, lack of overdose potential, etc.
The biggest part problem we seem to have with drugs is the relentless notion that taking any substance to enjoy a euphoria is wrong, leading us to just hang onto a whole panoply of drugs that have nasty side effects or risks. What if instead of continuing to fail to eliminate them, we simply out-competed the old drugs in the market by replacing them with better, cheaper safer drugs?
I think legalizing marijuana is part of this, because it actually has a lot of the qualities of a better drug -- once you're stoned, it's less useful to smoke more pot while you're stoned and at a certain point more pot doesn't really make you more high. It has an extremely low overdose potential, is non-addictive and doesn't produce much in the way of chronic health problems (smoking aside).
There are some people who are going to be a problem, and will be on a self destructive course, perhaps not much at all can be done to treat them. But those might be outliers? Who knows - certainly worth a try.
There's a whole combination of magical thinking clustered around the idea that only total sobriety is acceptable and that alternative solutions (like maintenance dosing or harm reduction) are judged by their failures instead of their successes.
Total sobriety has a terrible track record of success, yet it is judged by its successes and viewed as a solution because of its adherence to the ideology of total sobriety. Maintenance dosing or harm reduction is at least as successful, but is judged for its failures and condemned for its acceptance of non-sobriety.