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My Letter To The FDA (Re:Buprenex Status)

Tchort

Bluelight Crew
Joined
Mar 25, 2008
Messages
2,390
In the mail tomorrow.

To Whom It May Concern:

The changing attitude among the global medical community with regards to opioid addiction treatment has been a mostly positive development. Treatment methods that were once thought impossible to pursue are becoming the norm. Unfortunately, the United States has fallen behind many European nations (as well as Canada, Australia and New Zealand) when it comes to adopting new and innovative treatment strategies for opioid dependant addicts.

The passage of the Drug Addiction Treatment Act of 2000 (DATA2000) is a major step forward for American treatment options. I am writing to you now asking that the status of the medication brand Buprenex (Injectable Buprenorphine Hydrochloride [Generic]) have its Indications status updated to read, “Indications And Usage: Buprenex is indicated for the relief of moderate to severe pain and for the treatment of opioid dependence.”

With this status update, Buprenex and its generic form would meet the requirements of paragraph 2 subparagraph C of the Drug Addiction Treatment Act of 2000 which states:

“(C) For purposes of subparagraph (A), the conditions specified in this subparagraph with respect to narcotic drugs in schedule III, IV, or V or combinations of such drugs are as follows: "(i) The drugs or combinations of drugs have, under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, been approved for use in maintenance or detoxification treatment."(ii) The drugs or combinations of drugs have not been the subject of an adverse determination.”

Subutex and Suboxone (Buprenorphine Hydrochloride and Buprenorphine Hydrochloride/Naloxone Hydrochloride) currently meet these requirements. With the status update, Buprenex and its generic form could be prescribed either alone or with either Suboxone or Subutex as an adjuvant.

There is a sizeable population of Opiate Replacement Therapy patients receiving oral Methadone or sublingual Buprenorphine who continue to abuse opioids and other classes of drugs (Benzodiazepines, stimulants, etc). Some of these patients inject their oral Methadone or sublingual Suboxone or Subutex take home doses intravenously, which causes immense damage to the health of the individual and their treatment. This population has been the focus of efforts in other countries (Switzerland, the Netherlands, Canada, Sweden, Germany, etc) to utilize innovative treatment strategies to aid this sizeable minority of addicts. Injectable Methadone, injectable Diamorphine, injectable Hydromorphone, oral Dextromoramide, oral Morphine, and other strategies have been used. Few countries other than France have attempted to use injectable Buprenorphine in the form of Buprenex and its generic to treat this population. The efficacy and safety of Buprenorphine compared to other full agonist and partial agonist opioid medications is well established. The use of Buprenex as a beginning step to Opiate Replacement Therapy which would ideally result in maintenance with sublingual Buprenorphine is a well established treatment modality. This strategy is currently used in the United Kingdom with injectable and oral Methadone. A patient is started on injectable Methadone in conjunction with oral Methadone, and is gradually moved to oral only Methadone.

Please consider this change in the indications status of Buprenex, as it may result in life saving and at least life altering treatment opportunities for a population of Americans who many have considered beyond the help of treatment.

I am sending this in due to a particularly prickly anti-Buprenex article I read earlier. It was addressed to Pharmacists on how to spot a physician prescribing Buprenex off-label for opioid maintenance or detoxification, and how to get them in trouble (and at the very least how to stop the patient from receiving their prescribed medication).

I personally do not like Buprenorphine, and have a problem with how it is marketed, and how proponents of Bupe often align with anti-Methadone or anti-anything that isn't Bupe treatment people to push their agenda of making Suboxone/Subutex the only ORT option in the US.

But, I don't like assholes who try to directly stop addicts seeking treatment more :)
 
I really hope you didn't mail only one letter....... You should make numerous copies and send them to direct people.
 
I really hope you didn't mail only one letter....... You should make numerous copies and send them to direct people.

The first in a series of steps to lobby for this change. I have a plan worked out on an effective means to have this change enacted; starting with one letter. 'Rome wasn't built in a day'. I will update OD on the progress as it develops. :)
 
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You might want to cite sources showing the efficacy of this treatment in the countries you listed. They aren't really going to listen to you (I could be wrong), but they might listen to real data. Good job and good luck!
 
Great stuff Tchort. Very well written. Keep me posted
 
Very well written brother, keep us updated on responses and what your next steps are. :D

Do you have a link to that anti-Buprenex article? I'd be interested in reading it.
 
thats fucking awesome
see ive always seen it this way
WHY THE FUCK NOT?!??!!
if someones addicted to a drug, WHY not give it to them IN THE FORMULATION, that THEY WANT, in the dose THEY want (only you can know how much you need)
I mean, we do it with alot of drugs we give people prescriptions for methamphetamine and scripts for Benzo ampules and scripts for dillies or whatever................
If someones needs IV Heroin for WHATEVER reason be it wd, pain relief, or for just plain recreation I think its a WAYYYY fucking better to give them PURE Pharmaceautical grade shit already in ampules with clean syrnges. and GIVE THEM ENOUGH.
this way we CAN effectivly wipe out the black market (unless of course we continue to charge people their life savings for fuckgin health care in america)

If somones a meth addict, give them pure meth and syrnges becsaue they are going to do it ANYWAYS so as a doctor it seems it would be a doctors job to provide that meth and pokers who gives a fuck if they have some disorder. its called harm reduction.
if someones going to go out and buy an 8 ball of cut coke a day anyways laced with potentialy lethal or poisonus shit.........
why not prescibe them pure cocaine powder, syrniges, and give the patient a DIRTH of info just like you woudl when you gave them ANY other drug.
i mean well prescribe people shit if they have a paper saying "I have a sickness"
Why do you need to have anything to be able to access SAFE medicine? either way its self medication so we might as well give them the medicines they are going to take ANYWAYS but do it in a safe/er manner and actualy provide it to them it will get them off the streets and if they want more up their dose in a safe manner so they dont go sneaking around on you. the only reason bupe and pain patients sneak around and fail piss tests is ebcsaue they are not being adequetly treated. so give em some more fucking meds

I for one one pay an arm and a leg for a script for buprenex amps. cause otherwise Im just going to shoot my suboxone and likely get an abssess. why not just give me the amps and NEVER worry about having a medical issue?

fucking stupid goddamn system we live in
 
I sent an e-mail to the NAABT (National Alliance of Advocates for Buprenorphine Treatment) similar to the letter above. Here is the response I received:

We looked into this in 2000 when data-2000 was being debated. What we found was virtually no support for it within the key bodies necessary to make it happen, including the addiction scientists.



One of the reasons the sublingual formulation was developed was because of its slow onset. As you may know drugs that have slow onsets to their effects have a lower addiction potential than drugs that reach the brain faster. In a typical sample of pain patients (or the general population) only about 10% of people who take pain medication chronically become addicted to the medication, meaning they develop the uncontrollable dangerous compulsive behavior and lose control over their drug intake. However 100% the addicted population is made up from this 10%, so anyone receiving addiction treatment is at a higher risk of addiction than the average population. Injectable buprenorphine was thought to have too high of an addictive potential itself to be effective in treating addiction, due to its fast onset, when compared with the sublingual formulation. The initial “rush” after the injection is too similar to drugs of abuse to allow the brain to make the necessary adaptations back to addiction free life. Although I agree this is better than nothing in those countries where the sublingual formulation or methadone isn’t available, the hyper sensitive anti-drug coalition would not have allowed it to be used to treat addiction in this country. It seems they are more interested in protecting people from treatment medications than from addiction.



Others noted that the reconditioning of the brain necessary for sustained addiction remission would be hampered with daily injections since this more closely resembled addictive behavior, and could be reinforcing rather than reconditioning. The increased feeling of reward from the faster onset of the injectable formulation, could potentially keep the addiction active, although it would be much safer to the patient than using street drugs.



I can only see injectable buprenorphine being used in the future, at least in the US , if the onset could be slowed and if like Vivitrol, it could be formulated into a monthly injection. Titan pharma has developed a subcutaneous buprenorphine rod that lasts for 6 months.



Although I agree that no medication should be off limits to doctors and Buprenex should be available to doctors, as you mentioned, the current climate in the US (FDA, NIDA, DEA) makes it unlikely.



I disagree with your premises that the sublingual formulation of buprenorphine is only harm reduction, although I agree that the injectable formulation would be. Patients taking sublingual buprenorphine are able to stop their addictive behavior (not continue it with a safer legal medication) Once stable, the dangerous compulsion to take drugs is gone, patients regain control over drug use, missed days at work decrease, spread of HIV -HEP-C decrease, virtually all of the hallmarks of addiction disappear. This drastic change in behavior has a physical affect on the brain and actually allows a “rewiring”, reversing some of the changes caused by addiction. With successful behavior modification during the treatment period most patients will be able to make sufficient brain adaptations to transition off the medication and keep the addiction in remission with cognitive tools only. This is not a solely a harm reduction strategy, it is effective treatment.



Also patients with very high dependencies, like the ones you described, may not be able to get enough agonist effect from any dose of buprenorphine and will require the full agonist methadone. Patients unwilling to take bupe may find the methadone more acceptable since it is a full agonist. I don’t see where a patient who is unwilling to take a full agonist like methadone, would be willing to take an injection of a partial agonist, unless it producing a "rush" and in that case would be detrimental to sustained remission. Until a longer acting formulation of buprenorphine is available, I think the sublingual formulations of buprenorphine, and oral methadone can treat the majority of patients seeking help.



Lastly, many US physicians are undereducated when it comes to treating addiction. Despite knowing it is a chronic condition many don’t treat it like one, by offering 5 day treatments, or even UROD. I think part of the government’s resistance to approve any treatment medication stems form this lack of consistency and knowledge of modern addiction treatments. The current treatments are often administered improperly. We think education is the key to more treatment availability. For example, the FDA is reviewing and expected to approve an injectable depot version of naltrexone that last for 30 days for the treatment of opioid addiction (or opioid dependence as they term it). Naltrexone implants have been cut out by patients, who cannot tolerate the months of post acute withdrawal. If this drug is administered to patients too soon in their treatment it could cause people to start abusing non-opioid drugs like cocaine or methamphetamines, of which there is no medical treatment, or even cause some to succumb to the associated depression and commit suicide. Education must be the priority so potentially good treatments don’t become banned because of the consequences when used improperly. I'm sorry we can't get behind using injectable buprenorphine to treat addiction.

I am very grateful to both NAABT and NAMA (National Alliance of Methadone Advocates) for the work they do promoting Opiate Replacement Therapy treatment and education about addiction. I am not surprised by the response, and unfortunately I am sure this person is correct. The anti-ORT elements within the addiction treatment field (abstinence-only programs, faith based programs, Antagonist manufacturers, etc) and inside the government make the official change in policy regarding injectable ORT highly unlikely. However, unofficial, off-label use of Buprenex and its generic to treat opioid addiction and dependancy has been going on for years. It makes more sense to promote off-label treatment rather than trying to change the minds of policy makers who think Naltrexone implants are a good idea.
 
thats fucking awesome
see ive always seen it this way
WHY THE FUCK NOT?!??!!
if someones addicted to a drug, WHY not give it to them IN THE FORMULATION, that THEY WANT, in the dose THEY want (only you can know how much you need)
I mean, we do it with alot of drugs we give people prescriptions for methamphetamine and scripts for Benzo ampules and scripts for dillies or whatever................
If someones needs IV Heroin for WHATEVER reason be it wd, pain relief, or for just plain recreation I think its a WAYYYY fucking better to give them PURE Pharmaceautical grade shit already in ampules with clean syrnges. and GIVE THEM ENOUGH.
this way we CAN effectivly wipe out the black market (unless of course we continue to charge people their life savings for fuckgin health care in america)

If somones a meth addict, give them pure meth and syrnges becsaue they are going to do it ANYWAYS so as a doctor it seems it would be a doctors job to provide that meth and pokers who gives a fuck if they have some disorder. its called harm reduction.
if someones going to go out and buy an 8 ball of cut coke a day anyways laced with potentialy lethal or poisonus shit.........
why not prescibe them pure cocaine powder, syrniges, and give the patient a DIRTH of info just like you woudl when you gave them ANY other drug.
i mean well prescribe people shit if they have a paper saying "I have a sickness"
Why do you need to have anything to be able to access SAFE medicine? either way its self medication so we might as well give them the medicines they are going to take ANYWAYS but do it in a safe/er manner and actualy provide it to them it will get them off the streets and if they want more up their dose in a safe manner so they dont go sneaking around on you. the only reason bupe and pain patients sneak around and fail piss tests is ebcsaue they are not being adequetly treated. so give em some more fucking meds

I for one one pay an arm and a leg for a script for buprenex amps. cause otherwise Im just going to shoot my suboxone and likely get an abssess. why not just give me the amps and NEVER worry about having a medical issue?

fucking stupid goddamn system we live in

dude,i support the idea that a lot of the drugs that are illegal should be legalized and people could have a limited access to them and that OMT drugs should be easier and way cheaper to obtain,but there are a lot of drugs that do 1000000000x more harm than good and should stay illegal. Even if it is "pharmacy" grade pure stuff.

"If somones a meth addict, give them pure meth and syrnges becsaue they are going to do it ANYWAYS so as a doctor it seems it would be a doctors job to provide that meth and pokers who gives a fuck if they have some disorder"

this statement is so out of this world I can't even believe it!!!who cares that this guy is schizophrenic and has manic depresion disorder,let um have his pure meth8)its pure so your all good,cheers=Dim sure that would help people's situations. A world where anybody could just go get their pure meth, pcp,and heroin wouldnt be a world for very long....

OP--Great letter btw and good luck!!!
 
Great letter, Tchort.

thats fucking awesome
see ive always seen it this way
WHY THE FUCK NOT?!??!!
if someones addicted to a drug, WHY not give it to them IN THE FORMULATION, that THEY WANT, in the dose THEY want (only you can know how much you need)
I mean, we do it with alot of drugs we give people prescriptions for methamphetamine and scripts for Benzo ampules and scripts for dillies or whatever................
If someones needs IV Heroin for WHATEVER reason be it wd, pain relief, or for just plain recreation I think its a WAYYYY fucking better to give them PURE Pharmaceautical grade shit already in ampules with clean syrnges. and GIVE THEM ENOUGH.
this way we CAN effectivly wipe out the black market (unless of course we continue to charge people their life savings for fuckgin health care in america)

If somones a meth addict, give them pure meth and syrnges becsaue they are going to do it ANYWAYS so as a doctor it seems it would be a doctors job to provide that meth and pokers who gives a fuck if they have some disorder. its called harm reduction.
if someones going to go out and buy an 8 ball of cut coke a day anyways laced with potentialy lethal or poisonus shit.........
why not prescibe them pure cocaine powder, syrniges, and give the patient a DIRTH of info just like you woudl when you gave them ANY other drug.
i mean well prescribe people shit if they have a paper saying "I have a sickness"
Why do you need to have anything to be able to access SAFE medicine? either way its self medication so we might as well give them the medicines they are going to take ANYWAYS but do it in a safe/er manner and actualy provide it to them it will get them off the streets and if they want more up their dose in a safe manner so they dont go sneaking around on you. the only reason bupe and pain patients sneak around and fail piss tests is ebcsaue they are not being adequetly treated. so give em some more fucking meds

I for one one pay an arm and a leg for a script for buprenex amps. cause otherwise Im just going to shoot my suboxone and likely get an abssess. why not just give me the amps and NEVER worry about having a medical issue?

fucking stupid goddamn system we live in

Now that's ridiculous. I agree we should be given the tools, i.e. methadone and suboxone, to help us sustain some kind of NORMAL life. Not to get high. That's not the point of even full agonist methadone. It's (supposed) to be used to help those who can't get off the dope but given something that will keep them from getting sick, but not high and basically a useless individual. Handing out drugs isn't going to help anyone. The addict, nor those who love them. While recreational drug use is fun, but once you are addicted, your life turns to hell. It ruins families, esp. when children are involved. There is collateral damage done when one is hooked. My suboxone may not give me a high, but I love it for what it does for me...keeps me well and keeps me NORMAL.:|
 
I didn't even want to respond to that guy. Thats one of the dumbest posts I've read all year. I just have one thing to say:
I for one one pay an arm and a leg for a script for buprenex amps. cause otherwise Im just going to shoot my suboxone and likely get an abssess. why not just give me the amps and NEVER worry about having a medical issue?
Because its your own stupid choice?
Take responsibility for your dumb-ass actions and you'll be a much better person for it.
 
Wow, gangbang. I happen to agree with 'ofukibenhear' on a few points.

I completely disagree that if all recreational and addictive drugs were made available to users and addicts that the world would fall apart: it would only be a change for the better, as people use drugs whether they are legal, clean, pure, safe, etc or not. PCP, Heroin, Meth, Crack, etc are all available already- a 'British System'-esque state run program to administer clean paraphenalia (needles, ties, cookers, pipes, filters,etc), observe users and teach proper technique in 'consumption rooms', overdose recessitation classes and Naloxone nasal sprays, etc the infectious disease growth rate would plummet, crime would decrease dramatically, the subjective quality of life would increase. The drugs aren't the problem, it is the draconian legal system and punitive attitude towards users (and thus the illicit, unregulated market created by the former) that causes most of the problems related to drug use.


Anyway, I am starting work on a long essay on the topic of this post outlining treatment protocol, underlying philosophy of addiction that supports the use of this protocol, physiological action, legal ramifications, etc. All theory, I would like to make a voluntary questionnaire for BlueLight members to respond to concerning their impressions of oral Methadone and sublingual Buprenorphine treatments, whether they have ever or regularly inject their liquid or tablet Methadone or Buprenorphine, etc. Should be done in a few days, will update with a link once I get the questionnare finished and posted either in OD or BDD.
 
^^let natural selection take over for us..... I think thats where prescribing these kind of things would lead.
 
^^let natural selection take over for us..... I think thats where prescribing these kind of things would lead.

Ignorance at its finest. 'These kinds of things' are prescribed in bulk everyday; they're called 'narcotics'. IV, intrathecal, intraarterial, oral, rectal, nasal, IM, SC, sublingual; any way they can be put in the body, they are prescribed to go in that way. So if prescribing injectable or just plain old any form of narcotics were to 'lead' to something, it would've happened thousands of years ago when we first started eating poppy heads.

Also suggests that the assumption that all narcotics are 'deadly' or that drug abuse or recreational use is 'deadly' by its very nature, which it plainly is not.

So, how exactly does natural selection factor in? Oh, I get it, you mean that people who just injectable narcotics are innately stupid, so that means stupid people will inject these injectable narcotics and die, leaving all the smart people. But wait, I didn't know there was an intelligence test prior to developing addiction. I must've missed that day in school, where we learned that only stupid people can develop compulsive behaviors or diseases.

Thanks for clearing that up for me, I feel liberated knowing that the Ubermensch is real, and that he graced me with his presence on BL!
 
I completely disagree that if all recreational and addictive drugs were made available to users and addicts that the world would fall apart: it would only be a change for the better, as people use drugs whether they are legal, clean, pure, safe, etc or not.

I know you're suggesting that these drugs become available only to those who already use, but I disagree that 'people use drugs whether they are legal, clean, pure, safe, etc or not.' Any drug becoming more acceptable leads to more people doing it. There's a reason nicotine, caffeine and alcohol are the most commonly abused psychoactive drugs, and it's not because they're the best ones.

Great letter though, really well written.
 
anything some one uses to try and clean up their act is a step up whatever they use I wish them luck and always look up sooner or latter you'll get there
 
I have to agree with Tchort about the vast majority of individual and social problems related to drug use being the result of the laws and social prejudice directed at drug users. If you could walk into a store and buy a safe, clean dose of your favorite opiate, opiate addiction would be about as much of a social problem as cigarette smoking, not zero, but vastly less than it is today. The fact is that the average long-term opiate addict who has the means to support his habit and manages to stay out of trouble with the law can be be just as productive a member of society and have as normal, fullfilling life as a non-addict. This amy not be true with drugs such as meth, but I have no personal experience with meth so I can't really comment on its effects. I know that a few years ago i lived in southern Cali about 20 mins from the border, and I would take the train down there every morning, walk across the border, buy an OC 80 from one of the street vendors, shoot it up in the back of his stall (with my own clean equipment and fresh rig), and walk back into the US, take the train home and go to work. I never missed work because I had to hustle to find my dealer, or got sick because nothing was around, or had to steal or do anything fucked up to get money or dope. I never had any of the problems, health related or otherwise, that you hear about addicts having. This was similar in many ways to what going to a methadone clinic must be like, but I got to do oxycodone instead of methadone and was able to inject instead of taking it orally. This experience proved to me that the vast majority of harmful effects associated with opiate addiction arecaused not by the drug but by the social conditions that surround it.
 
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