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rickpsfuckyou
listening to Mozzy



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Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts
#23721514 - 10/09/16 09:09 AM (7 years, 3 months ago) |
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http://www.thedailybeast.com/articles/2016/10/05/suboxone-creator-said-its-pills-killed-kids-to-make-1-billion.html
PHILADELPHIA — In 2009, with opioid-painkiller deaths at an all time high in America, a British consumer goods company you’ve probably never heard of was facing a crisis of its own.
That year, Reckitt Benckiser’s patent for its opiate-treatment drug Suboxone expired, opening the gates for cheaper generic versions of the medication to hit the market. At stake was the loss of the company’s 85 percent hold on the market for medication-assisted treatment, which was booming thanks to the growing opiate epidemic. Hundreds of millions stood to be lost from the patent’s expiration.
According to a massive antitrust lawsuit made public last week, that’s when Reckitt Benckiser decided to destroy the Suboxone market in order to keep it.
Thirty-five states and the District of Columbia are named as plaintiffs in the suit, which was filed under seal in federal court in Philadelphia on Sept. 23.
A copy of the 92-page, partially redacted complaint describes how the company, spin-off company Indivior, and a third company called MonoSol RX gamed the pharmaceutical regulatory process using a variety of “deceptive and unconscionable” practices to maintain a chokehold on the emerging market for medicine-based addiction treatment.
The case against Reckitt Benckiser accuses it of “product hopping,” in which a company tweaks its product slightly, often without any actual improvements, and then applies for a new patent with the intent of keeping its market share intact. In Reckitt Benckiser’s case, the product switch was from the orange Suboxone tablets it had been successfully marketing to a new dissolvable film strip that was developed by co-defendant MonoSol RX.
The plaintiffs in the lawsuit say Reckitt Benckiser took product hopping to a nefarious new level by using “feared-based messaging” and “sham science” to illegally subvert the market for Suboxone tablets while aggressively promoting its new film variation, which was introduced in 2010 and is under patent until 2023.
“The circumstances alleged in this case are particularly egregious in that, in the midst of an epidemic of opioid abuse and addiction… consumers and taxpayers have had to pay more for a drug that may help to mitigate some of the problem,” said George Jepsen, the attorney general of Connecticut, in a statement announcing the suit.
Reached for comment, a spokesperson for Reckitt Benckiser’s Suboxone division Indivior told The Daily Beast that while the company can’t comment in detail about pending litigation, “we disagree with a number of the claims made by the attorneys general, and we will contest this lawsuit vigorously.”
Patent expiration is a conundrum faced by all drug makers and ordinarily it wouldn’t be a terribly big deal for a global monolith like Reckitt Benckiser—which generated more than $2.5 billion in revenue during the first half of 2016 through its ownership of popular brands like Lysol disinfectant, Mucinex cold medicine, and Durex condoms.
But nothing was quite like Suboxone, a blend of the painkiller buprenorphine and the opiate blocker naloxone.
Buprenorphine was first developed by Reckitt Benckiser in the 1960s and has been used to treat moderate pain for years. Since 2000, physicians have been authorized to use the drug to treat a limited number of patients for opiate dependency. By combining the drug with naloxone—which causes the immediate onset of withdrawal symptoms if the product is inappropriately melted and injected—Reckitt Benckiser made it harder to abuse, greatly broadening its appeal as a drug for treating opioid dependency.
Reckitt Benckiser won exclusive rights to market Suboxone in 2002, and prior to that had fought a laborious and costly battle to convince legislators to approve buprenorphine as a first-line treatment for opioid dependency. But since both of its active ingredients are so-called legacy drugs—meaning they are no longer individually under patent—the company was only granted a seven-year “orphan drug” patent for Suboxone instead of the standard 20 years given to most new drugs.
By the time it lost its monopoly, Suboxone accounted for 85 percent of all spending on medication-assisted treatment in the U.S.—almost all of it subsidized by taxpayers—and Reckitt Benckiser was sitting on the pharmaceutical equivalent of a goldmine.
That’s when it got creative.
The plaintiffs accuse the company of undermining the market for generics through a “multi-step scheme” that began in 2010 with an aggressive effort to get prescribers to stop dispensing its own Suboxone tablets and replace them with the new film version.
Over the next two years, Reckitt Benckiser allegedly compensated doctors for being advocates of the drug, lobbied legislators on the benefits of Suboxone film, and penalized employees for not meeting sales targets for the new drug. It also raised the price of its tablets, making them more expensive than the newer film version, even though the pills are cheaper to make.
In September 2012, with generics getting closer to approval, Reckitt Benckiser announced its intention to take tablet versions of its drug off the market on the grounds that the pills posed a safety threat to children who might inadvertently eat them. On the same day it filed a “Citizen’s Petition” with the Food and Drug Administration calling on the agency to postpone approval of generics in the interest of public safety.
The company based its child-safety claims on a single study it had paid for itself. According to the plaintiffs it used the findings to sow fear among medical professionals and encourage them to dispense only Suboxone film.
According to an article in the Financial Times, the company said its study demonstrated that the risk factor for accidental ingestion by children was eight times greater in bottled tablets than in its individually packaged film. Yet its own data only showed six cases of pediatric poisoning in children under six for every million tablet doses dispensed.
Compared to the more than 20,000 deaths in 2012 from prescription opiates and heroin, pediatric poisoning from Suboxone was far from a public health crisis. A preliminary study commissioned by Reckitt Benckiser found just 46 cases of serious injury or death out of more than 2,200 accidental pediatric exposures to Suboxone tablets between 2010 and 2012—which researchers described as not significantly different from poisonings from the film.
Along the way, the company racked up about a dozen antitrust lawsuits against it that were filed by would-be competitors and health care payees who say they overpaid for buprenorphine treatment.
The FDA called Reckitt Benckiser’s study inconclusive and noted that accidental pediatric exposure to Suboxone had actually been on the decline—which it attributed to new labeling requirements.
“After review of the clinical study report… our overall conclusion is that the study was poorly designed and conducted and was not useful for demonstrating any difference in the safety profile or abuse potential of the two formulations,” the FDA said in its response to the petition. “The agency has determined, on the basis of data available, that withdrawal of Suboxone tablets is not necessary for safety reasons.”
It went on to say that “Reckitt’s own actions also undermine, to some extent, its claims with respect to the severity of this safety issue. Notwithstanding the availability of data showing an increasing rate of accidental pediatric exposure through at least the first part of 2010, and the first report of pediatric death in June 2010, Reckitt did not discontinue marketing of the tablets in multi-dose containers for more than two years.”
The FDA rejected Reckitt Benckiser’s petition to essentially ban the very product it had been happily selling for seven years—and that it continues to sell throughout Europe, where Suboxone tablets are still under patent. The company is also working aggressively to get the tablets approved for use in China, according to the suit.
The FDA further noted that “timing of [Reckitt Benckiser’s effort]... given its close alignment with the period in which generic competition for this product was expected to begin, cannot be ignored,” and referred the company to the Federal Trade Commission for possible anti-competitive behavior.
In June 2013 the FTC opened an investigation into whether Reckitt Benckiser abused public regulatory processes and fought for nearly two years to obtain more than 20,000 documents the company was fighting to withhold. That case is ongoing. In December of that year, federal agents raided Reckitt Benckiser’s West Virginia offices after the Department of Justice launched a criminal probe into the company’s Suboxone business. That investigation continues.
Consumer advocates agree that Reckitt Benckiser broke new ground with its product-hopping scheme.
“Few, if any, companies have gone as far as to pre-emptively withdraw an off-patent drug from the market to make way for a newly patented successor in the way that British-based Reckitt Benckiser Pharmaceuticals did,” said Public Citizen, an advocacy group that says it exposes malfeasance in industries that threaten consumer interests.
For its part, the company stands by its actions.
“We make our decisions based on how best to address the unmet needs of patients from a treatment and public health perspective,” a spokesperson said via email.
Jose Sierra, an attorney with the Boston law firm Laredo Smith who advises pharmaceutical companies on ethics and compliance issues, says that “doesn’t pass the smell test.”
“I think this has a serious optics problem,” he told The Daily Beast. “No one bothered to tell them this is going to look terrible. I don’t want to say that these guys disregarded everything for money, but I can agree it does look that way.”
Indeed, if the allegations in the new lawsuit are true, Reckitt Benckiser sought to exploit the nationwide hysteria over the increasing use of opioids to line its own pockets by blocking competition and keeping prices artificially high. According to one estimate, between 2009 and March 2013 when the FDA finally approved generic buprenorphine/naloxone, Suboxone generated more than $1 billion in annual sales, or 20 percent of the company’s profit base, and 3 million Americans had been treated with the drug.
Three weeks after the first generics hit the market, Reckitt Benckiser made good on its promise to withdraw tablets from the U.S. market. Against the odds, the off-brand drugs have managed to chip away at Reckitt Benckiser’s market for addiction treatment drugs.
According to a recent investor presentation by Indivior (PDF), generics now make up about 20 percent of the market for buprenorphine treatment.
But that hasn’t really translated into a payoff for consumers. There are only four alternatives to Suboxone for sale in the U.S. market. And none of them can be substituted for the brand name. That’s because two of them—Zubsolv and Bunavail—aren’t really “generic” at all. They contain different dosages of the active ingredients than Suboxone, making them more like alternative brands.
The other two—developed by the the pharmaceutical companies Amneal and Actavis, share the same drug formulation as Suboxone tablets, but since Reckitt Benckiser no longer sells tablets in the U.S., pharmacists can’t substitute the generics for the branded version (as they are required to do under many state laws). The fact that generic Suboxone has any market at all is primarily due to health insurers like CVS Caremark and United Healthcare dropping the branded version from their formularies in favor of ostensibly cheaper generic equivalents.
Partly as a result of limited competition, however, prices for both Suboxone and its generic alternatives remain high—with treatment ranging from $200-$500 a month per patient.
For the approximately 15 percent of patients who pay for the drug in cash, the financial burden is even steeper.
Dosing guidelines recommend a maintenance dose of 16mg of buprenorphine a day, the equivalent of two standard Suboxone films. A pharmacy in North Philadelphia quoted The Daily Beast a cash price of $10 a pill for the generic version made by Amneal Pharmaceuticals.
Meanwhile, due to limited choices and delayed competition, to many patients and doctors, Suboxone has become synonymous with any treatment involving the buprenorphine/naloxone combination.
A nurse at one North Philadelphia drug-treatment clinic that dispenses Suboxone said she had never heard of the drugs Zubsolv or Bunavail when visited recently by The Daily Beast.
An addiction doctor in Philadelphia, who asked that his name be withheld, said he defaults to writing Suboxone prescriptions unless a patient specifically asks for something else. Out of 118 patients, only about five take something other than brand-name Suboxone, he said.
“A representative from the company that makes Bunavail visited me and I tried recommending it to patients but they don’t want to switch,” he said. “It’s like patients are paranoid it won’t be the same, or something. There’s a lot of misinformation… on the street.”
Whether Reckitt Benckiser was illegally gaming the system or simply practicing good business will now be decided in a courtroom in Philadelphia. States could recoup millions if it is determined that the company violated antitrust laws.
Legal experts disagree about whether product hopping is a crime. The Federal Trade Commission has argued that it can be if it has the effect of coercively undermining consumer choice. The agency has recommended that extra scrutiny be placed on the pharmaceutical industry where “the potential for anticompetitive product redesign is particularly acute.”
Yet courts have been reluctant to bring the hammer down on the practice of product hopping, and the cases that have been litigated appear to fall in Reckitt Benckiser’s favor.
Just days after the multi-state suit against Reckitt Benckiser was made public, a federal appeals court upheld the legality of product hopping in an ongoing antitrust case filed by Mylan against its competitor Warner Chilcott.
The judge overseeing the Suboxone antitrust litigation apparently thinks it has merit. In rejecting Reckitt Benckiser’s motion for a summary judgment in a related antitrust case in 2014, Judge Mitchell Goldberg wrote:
“The the facts presented sufficiently allege that the disparagement of Suboxone tablets took place alongside ‘coercive’ measures. The threatened removal of the tablets from the market in conjunction with the alleged fabricated safety concerns could plausibly coerce patients and doctors to switch from tablet to film.”
Whatever the outcome, Reckitt Benckiser will have a difficult time shaking the public relations impact of the accusations against it. But if recent scandals have taught us anything, it’s that in the pharmaceutical industry, image is rarely as important as profits.
Correction, 10/05/16, 1:20 p.m.: Indivior is not a subsidiary of Reckitt, it was spun off from Reckitt's buprenorphine division in 2014 as a standalone company, with Shaun Thaxter, the head of Reckitt Benckiser Pharmaceuticals, named as CEO.
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Dark_Star
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: rickpsfuckyou]
#23721608 - 10/09/16 10:00 AM (7 years, 3 months ago) |
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This doesn't surprise me in the least. They also marketed it as a non-addictive treatment for opioid dependency - total bullshit. The recommended dosages - way higher then necessary. This is a classic example of how shady big pharma is.
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GPryder
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Dark_Star]
#23721628 - 10/09/16 10:07 AM (7 years, 3 months ago) |
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I've gotten some suboxones from friends in the past and those things fucked me up just as much as taking 8-10 norcos. Just replacing one addictive high with another.
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  Check out my first grow log. Completed successfully! Experienced: Weed, LSD, Mushrooms, DOC, DXM, MDMA, DMT, 1P-LSD, AL-LAD, ALD-52, 4-HO-MET, 4-HO-MiPT 4-ACO-DMT Interested in: Ketamine, MDA.
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ellomello
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: GPryder] 1
#23721793 - 10/09/16 11:11 AM (7 years, 3 months ago) |
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SHOCKING! At least we can trust the methadone, oxycodone, and marjinol companies.
-------------------- PAY NO ATTENTION TO THE MAN BEHIND THE CURTAIN get back to the garden
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LeeHarvOz
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: GPryder]
#23721871 - 10/09/16 11:43 AM (7 years, 3 months ago) |
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Quote:
GPryder said: I've gotten some suboxones from friends in the past and those things fucked me up just as much as taking 8-10 norcos. Just replacing one addictive high with another.
yea i hate when people say that suboxone dosent get you high, thats a bunch of bullshit. i got in a big argument with a counselor in outpatient rehab about that.
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Dark_Star
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: LeeHarvOz]
#23721943 - 10/09/16 12:05 PM (7 years, 3 months ago) |
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Seriously. Towards the end, when I was yo-yoing between heroin & suboxone, I'd look forward to when I'd be taking suboxone, because I knew I'd feel great. There was a great sense of wellbeing with it. Honestly by then there was more of a sense of wellbeing with suboxone then there was with heroin. And when I finally came off suboxone I was dope sick for a month. Not addictive my ass.
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rickpsfuckyou
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Dark_Star]
#23722176 - 10/09/16 01:07 PM (7 years, 3 months ago) |
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i have never done suboxone but methadone wafers had me nodding for two days straight way back when.
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Ellis Dee
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: rickpsfuckyou]
#23722328 - 10/09/16 01:49 PM (7 years, 3 months ago) |
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This practice referred to as "product hopping" in the article is a common practice in the drug business. Usually the company add an "extended release" medicine when it expires, or apply for another patent related to the manufacturing process of an intermediate compound near expiration. Sometimes they just tweak the formula a little for no reason and call it a new medicine. One drug company I remember making prescription prenatal vitamins just tweaks the ratio of vitamins and then promotes the new formula to obstetricians all over the country through its army of "drug reps" (salesmen). And thats sure easier than bothering to invent a new drug. Anything to keep milking the last few drops from the cash cow. Its just the way things are done.
-------------------- "If the foundations be destroyed, what can the righteous do."-King Solomon And there was war in heaven: Michael and his angels fought against the dragon; and the dragon fought and his angels,
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badchad
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Ellis Dee]
#23722376 - 10/09/16 02:06 PM (7 years, 3 months ago) |
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Quote:
Ellis Dee said: This practice referred to as "product hopping" in the article is a common practice in the drug business.
Yup. It's normal. Moreover, it doesn't stop the original drug from going generic so its not of much consequence unless the new drug/formulation is substantially, and legitimately better.
-------------------- ...the whole experience is (and is as) a profound piece of knowledge. It is an indellible experience; it is forever known. I have known myself in a way I doubt I would have ever occurred except as it did. Smith, P. Bull. Menninger Clinic (1959) 23:20-27; p. 27. ...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely. Osmond, H. Annals, NY Acad Science (1957) 66:418-434; p.436
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musiclover420
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: badchad]
#23722480 - 10/09/16 02:39 PM (7 years, 3 months ago) |
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So they are getting sued over this right? I hope they lose all the money they made from this and then some...
-------------------- Don't worry about me, I've got all that I need. And I'm singing my song to the sky You know how it feels, With the breeze of the sun in your eyes. Not minding that time's passing by I've got all and more, My smile, just as before. Is all that I carry with me I talk to myself, I need nobody else. I'm lost and I'm mine, yes I'm free
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Connoisseur

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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: musiclover420]
#23722734 - 10/09/16 04:04 PM (7 years, 3 months ago) |
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shocking? of course subs is a total scam, start to finish they are shit.
opium and kratom all the way.
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Sheekle
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Connoisseur]
#23723903 - 10/09/16 10:41 PM (7 years, 3 months ago) |
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Haha, yeah, raw opium is totally better Conn.
-------------------- "Ur cat died because he hated u" - Koods "I hope JSB kicks your ass one day." - Vandago "you are the biggest 'internet guy' I have ever come across"- Jokeshopbeard "The more I see you post the more I realize you're just this fuckin tie dye loser who trolls the Shroomery 24/7." - Herbologist "Sheekle you cannot vile the dice of bullshit you have posted on this forum over the years, I like databases" - thelastoneleft "or maybe i just come from a blood line of superior intelligence" - trees R.I.P Kelsy, ?/?/?? - 6/11/16
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Connoisseur

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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Sheekle]
#23723947 - 10/09/16 10:58 PM (7 years, 3 months ago) |
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raw opium is more practical
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Dark_Star
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Connoisseur] 1
#23724218 - 10/10/16 03:40 AM (7 years, 3 months ago) |
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Kicking opioids period & focusing on actual recovery is far more practical than any maintenance.
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Fractal420
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Dark_Star]
#23724439 - 10/10/16 08:21 AM (7 years, 3 months ago) |
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Buprenorphine itself is actually great for this and i wish it was available for anyone who wanted it. It gets one used to not feeling "doped up" all the time, and makes the adjustment to sobriety much less of a shock. Its a partial agonist (like weed, has a ceiling effect) and it will get someone who is opiate-naive high BUT only for like 5 days, after that, pretty much nothing. Someone who is using it on the regular is NOT getting high (not referring to shooting or whatever, just sublingual as prescribed). Within a week all noticeable psychoactive effects are gone. It is substitution therapy but it does work. For people who say the withdrawal is too long (it is actually milder than full agonists such as dope and oxycodone), id recommend switching to codeine at the very end of the taper. Like 1 codeine a day for a week, and then stop. This schedule will reduce most of the trouble greatly. Anyway though, i hate Reckitt and Benckisser (even the name is so....gross and english lol). I have to say as a real tool for beating addiction, i think buprenorphine happens to be more practical than kratom, ibogaine, or any of those. Its mostly the partial agonist thing. I feel suboxone the brand has just earned alot of negative word of mouth from people on the street spending $10 a pill/strip. Used theraputically it does work wonders. R+B are only one of a bunch of companies that jumped on the dope game bandwagon, and yeah its shitty of them, going so far to profit from addicts who already are just trying to recover and have it rough. Because buprenorphine actually is good medicine.
-------------------- Dreaming of That face again. It's bright and blue and shimmering. Grinning wide And comforting me with it's three warm and wild eyes. Prying open MY third eye
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Everything
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Fractal420]
#23726195 - 10/10/16 06:55 PM (7 years, 3 months ago) |
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I agree very much with the last two posts. Actually quitting use of any opiate/opoid is the first step. Subutex/suboxone is just a buffer zone from serious use.
Suboxone is indeed a wonder drug but it's almost harder to quit then dope because of how long the acute withdrawl lasts. So it's very important not to use it to too long like me.
and yeah suboxone definitely gets you high, even if you've been doing it a long time, you just take more like with any drug. However the high isn't something people strive for, people using suboxone are usually trying to get off heroin and so if they wanted a high they'd just use dope.
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Dark_Star
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Fractal420]
#23727370 - 10/11/16 04:00 AM (7 years, 3 months ago) |
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Bullshit. Sublingual most certainly got me high & feeling doped up....and I took far less then the doses prescribed to most. And that good feeling never went away, even when I stepped down further. And I also got full blown opioid withdrawals form sublingual. It wasn't until the end that I started snorting it, and I didn't do that all the time cause there wasn't any real difference from sublingual, except it didn't last as long. It's just a bandaid....a substitute. I felt all good about my recovery when I was on it, only to find out that there was no recovery when I finally came off it. Recovery happened when I got clean.....really clean.
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Fractal420
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Dark_Star]
#23727536 - 10/11/16 07:20 AM (7 years, 3 months ago) |
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Quote:
Dark_Star said: Bullshit. Sublingual most certainly got me high & feeling doped up....and I took far less then the doses prescribed to most. And that good feeling never went away, even when I stepped down further. And I also got full blown opioid withdrawals form sublingual. It wasn't until the end that I started snorting it, and I didn't do that all the time cause there wasn't any real difference from sublingual, except it didn't last as long. It's just a bandaid....a substitute. I felt all good about my recovery when I was on it, only to find out that there was no recovery when I finally came off it. Recovery happened when I got clean.....really clean.
What opioid were you on before that? The Only way i can i imagine this happening is if you were opioid-naive or not at all dependent and you were taking them for recreation. Because anyone with any tolerance, even methadone stops working, and thats some powerful stuff. Bupe works for 2 days to a week when administered constantly. At most like 2 weeks. And by the way since its a partial agonist it is mainly the lower doses that induce a well-being, believe it or not (like how if you smoked 5 blunts, the effects would be very different than two bowls, as in maybe lesser. Both have ceiling effects)
-------------------- Dreaming of That face again. It's bright and blue and shimmering. Grinning wide And comforting me with it's three warm and wild eyes. Prying open MY third eye
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Dark_Star
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Fractal420]
#23730230 - 10/12/16 04:52 AM (7 years, 3 months ago) |
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I was on heroin & painkillers for several years beforehand. You're just spouting the same bullshit the pharm companies do about this shit. It gives a high & a high that lasts, and it's physically addictive. I wasn't using it get high. I was using to try to kick a nearly decade long battle with opioid addiction. And it didn't at all for that.
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Fractal420
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Re: Suboxone Creator’s Shocking Scheme to Profit Off of Heroin Addicts [Re: Dark_Star]
#23730389 - 10/12/16 07:38 AM (7 years, 3 months ago) |
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^not spouting anything, that is exactly how i feel on the subject. Ive had to take it myself as well at some point. Just because your opinion is different doesnt mean you get to call my opinion "bullshit". Anyway believe what you want. Just cause something doesnt work for you, but it works for many other people, it then is bullshit?
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