Suboxone Assisted Treatment
Happy Easter 2008
When one door closes another door opens; but we so often look so long and so regretfully upon the closed door, that we do not see the ones which open for us. - Alexander Graham Bell
Success, Setbacks In France
French approach to drug offers lessons that United States has largely overlooked.
PARIS-Dr. Jean-Pierre Aubert considers himself not only a general practitioner but a dealer of sorts.
From his second-floor office up a winding staircase in an apartment building near the Sacre-Coeur Basilica, the doctor prescribes a drug called buprenorphine to 200 patients as a way to treat opiate addiction.
He is not an addiction expert. He does not screen patients to ensure that they, in fact, are opiate-dependent and need treatment. He concedes that some of them might misuse the medicine, including by injection. And he acknowledges that some of the pills he prescribes might end up the stuff of street sales.
Getting addicts in the door is what matters. Even patients who initially show up seeking the drug to get a fix, he said, might progress into proper treatment.
"I'm a legal dealer," he said. "But being a legal dealer, I can help them with many, many other health issues."
Aubert, along with 20,000 other doctors prescribing the medication in France, embodies the revolutionary approach the country adopted 11 years ago in its fight against drug use and the public health problems that accompany it. The French system encourages physicians unfamiliar with addiction to prescribe buprenorphine and trusts patients to use it properly.
In many ways, the plan has worked. The medication, which dampens the craving for opiates, has helped to drive down overdose deaths and contain the spread of HIV/AIDS among injectors. Schering-Plough, the company that sells it in France, terms it a "tremendous success story."
But the French experience also has a down side, one the United States largely overlooked when it followed a similar path by giving private doctors authority to prescribe buprenorphine to addicts.
Buprenorphine, available in France in a formulation called Subutex, has proved addictive for many and has been widely abused. Pills that addicts legally take home are being sold illegally, just like heroin.
United States Parallels
Similar problems have begun to emerge in the United States. Street sales are increasing, leading to growing abuse of the drug, a Sun investigation found. American addicts are also injecting buprenorphine, even though U.S. officials took the precaution of approving a form of the drug, Suboxone, with a chemical intended to deter injection. It is the only difference between the two formulations.
With the longest experience in using buprenorphine to treat addiction, France provides the clearest picture of the implications of making such a powerful opiate widely available.
Buprenorphine has become an entry drug for people who haven't used opiates before, a re-entry drug for former addicts, and a factor in more than 100 deaths since 1996 when taken in combination with other substances, according to researchers and public health authorities.
The drug has created a quandary that no one seemed to anticipate: how to get patients off it. Many stay in treatment for years, including some who want to quit, prompting criticism that substitution therapy doesn't address the underlying problem of opiate dependence.
Buprenorphine has been widely sold on the streets of France, and well beyond. A report by the French Monitoring Center for Drugs and Drug Addiction found that a fifth to a quarter of all buprenorphine sold was being illegally diverted. Pills originating in France are being smuggled to places as far-flung as the nation of Georgia and the Indian Ocean island of Mauritius.
"It's overprescribed, and it's too easily prescribed, without any control," said Dr. Agnes Lafforgue, who helps recovering addicts at a treatment and assistance center in Toulouse, a university city in southwest France.
She questions treating longtime heroin injectors with Subutex, for fear they will inject it, too, and worries about its addictive qualities. She said she has "practically never" successfully weaned a patient off it, despite having done so many times with methadone.
"It's a scandal the way Subutex has been introduced in France," she said.
Aubert and other doctors concede it is easy for a patient to get multiple buprenorphine prescriptions from multiple doctors, and sell the pills. Yet he maintains that such sales don't make the treatment program a failure, as it connects addicts with the health care system and provides them what he considers a safer drug. The government shares that view.
Good medicine involves a sometimes precarious balance for which there is no textbook guide. With every course of treatment they prescribe, physicians have to weigh potential benefits against the possibility of harm. The introduction of buprenorphine treatment in France - and elsewhere - raised that issue: how to properly balance widespread access to the drug, getting as many addicts as possible into treatment, with adequate control.
Health officials in France introduced Subutex a year after methadone, less to try to cure the country's estimated 150,000 addicts than to reduce the associated dangers of intravenous drug use - principally, the spread of HIV. At the time, up to 40 percent of addicts using needles were thought to be infected.
Officials believed it would be impossible to stem HIV by treating addicts with methadone alone; as in the United States, methadone was administered initially under tight supervision only at specialized centers. There were hardly enough of the centers. And methadone carried a much higher risk of fatal overdose.
In giving general physicians the right to prescribe buprenorphine from their offices, the government did not require training or certification and placed no limit on the number of patients doctors could treat. The United States, by contrast, requires minimal training - eight hours - and limits a doctor's buprenorphine practice to 100 patients.
In France, no central registry tracked prescriptions, and tablets were dispensed in take-home doses like antibiotics or antihistamines.
By the late 1990s, 65,000 French patients were taking Subutex. By 2005, the number had climbed to 90,000, nine times more than the total taking methadone, according to researchers. Schering-Plough estimates that 85,000 people are being treated now.
"We needed to urgently treat heroin addicts," said Nathalie Arens-Richard of the French Health Products Safety Agency, which, like the U.S. Food and Drug Administration, monitors the safety and misuse of medicines. "We didn't know what the problems with the treatment were going to be."
Over the years, concerns over misuse and the high costs for the government led to adjustments in how Subutex is dispensed. In 1999, France tightened the take-home limit. In 2004, the government further clamped down to counter a black market trade that France was, in effect, subsidizing. Subutex had become one of the top drugs paid for by the government.
Although the 2004 change prevented patients from submitting multiple prescriptions for reimbursement, they still could fill multiple prescriptions as long as they paid for the drug themselves. Critics suggested the government had acted not because of health or social costs but rather budget concerns.
Last year, the French health ministry rejected a proposal to reclassify the drug in a way that would result in tougher penalties for peddling it.
Michel Mallaret, president of the National Commission on Narcotics and Psychotropic Substances, recognizes the trafficking problem but sees benefits in keeping the drug widely available.
"We have to be very cautious if we have more control," he said. "The great risk is to see AIDS increase again, or injection, or overdose."
French officials have also discussed using Suboxone, which the European Union approved for marketing in 2006. But the government has been weighing whether that makes sense, given the possible higher cost of Suboxone and doubts about the effectiveness of its injection deterrent.
Pierre Chappard is typical of Subutex users who prefer to inject it. The former heroin addict has been receiving the drug by prescription for 10 years and is dependent on it. Twice he tried to quit but, for now at least, has given up on giving it up.
Four times a day, the one-time high school math teacher shoots up the drug and feels a pleasant rush. Chappard, 35, first used Subutex the year it was introduced, crushing it and mixing it in an injectable solution. It didn't give him the same flash as heroin, but it sufficed. Best of all, it was legal. You could get it from a regular doctor, and France's health care system would pay the cost.
Chappard is among the many addicts who say they can't, or won't, give up the ritual of injection. "The people who have injected heroin, we won't go to a Subutex pill," he said. "To just stop injecting and start taking a pill, it's too difficult."
But he admits to a motive beyond that: "You're injecting because you want more effect. The Subutex gives me a little bit of high, but I'm normal."
He still shoots heroin a few times a year but said he doesn't share needles. He filters his Subutex to remove large particles that could make injection dangerous.
"The biggest advantage of substitution treatment is it allows me to avoid AIDS, prisons and hepatitis," said Chappard, who works for Self-Help for Drug Users (ASUD), an association of current and former drug users that lobbies for such treatment.
Instead of going to see a dealer, I go to see a doctor."
For some, Subutex use has had unintended effects. Injectors who were not as careful as Chappard developed abscesses, infections, swollen limbs and blocked veins. Eric Schneider, national president of ASUD and a former heroin injector, said he witnessed this aspect of Subutex abuse almost as soon as the drug became available.
"The lucky ones only lost maybe a couple of fingers, the unlucky ones lost a leg or an arm," said Schneider, co-director of a drop-in center for addicts in Marseille.
He had anticipated that drug users would inject Subutex, in part because France had experienced a problem with the injection of Temgesic, a low-dose form of buprenorphine also sold by Schering-Plough as an analgesic.
"Nobody could tell me that people would be observant and take it as prescribed, knowing it was as easy to inject as Temgesic," Schneider said. "Injectors will inject, that's why they're injectors. So if we put something on the market that's injectable, we shouldn't be surprised that they do."
The French monitoring center reported in 2004 on Subutex trends. Because of its widespread availability, Subutex was serving as a first opiate for some drug users and a re-entry opiate for some who had previously injected heroin. The report found it to be highly addictive and hard to stop. And it was increasingly being used in dangerous combinations with alcohol, benzodiazepines (such as tranquilizers) and even cocaine.
Subutex was implicated "as a contributing or causal factor" in 136 deaths in France from 1996 to 2000, in combination with benzodiazepines, alcohol or other substances, according to a 2004 article in the American Journal on Addictions. From 2001 to 2005, Subutex was implicated in combination with other substances in 31 deaths, according to government and police reports.
Researchers say that in the early years of buprenorphine prescribing, there was not widespread awareness of the danger of prescribing it with other drugs.
Serge Escots, a family therapist and addiction specialist in Toulouse, did some of the research on the unintended hazards of Subutex use.
"We could see it," he said. But, "If I talked about it, [Subutex proponents] said, 'You're wrong, you're anti-substitution, you're against public health, you want to see AIDS all over the street.'
"You couldn't talk about it. We weren't invited to talk about it. We were only invited to say good things about it," he said.
Subutex's staunchest supporters in and out of government embrace the public health philosophy known as harm reduction. It acknowledges that some addicts can't or won't quit their habits, and emphasizes ways to minimize the dangers.
Buprenorphine has played a major role in addiction treatment that has saved 3,500 lives, experts say. Opiate overdose deaths have declined 79 percent since the drug was introduced, and the HIV infection rate among injection drug users has fallen sharply - from 40 percent in 1996 to 20 percent in 2003.
"The difficulty, the problem, of Subutex is [that] on one side, it has helped enormously," said Xavier Thirion, a buprenorphine proponent who tracks trends for a Marseille-based center on drug dependency research. "On the other hand, we found the misuse. Every policy has advantages and disadvantages. All of public health policy is about balance."
Schering-Plough has aggressively promoted the drug in France, funding the work of harm reduction groups. Company officials say they are aware of the trafficking and misuse. By their estimate, 25 percent of patients use buprenorphine "non-medically," a figure that includes illegal sales and inappropriate practices such as injection and drug sharing. They term that "a small number" and say the benefits of treatment outweigh the risks especially given the level of opiate addiction.
"By all accounts, what you have is a tremendous success story of the benefits of increasing access to therapy - making it available through general practitioners - and the tremendous benefits to the public health of the community," said Leslie Amass of Schering-Plough's Global Medical Affairs Department.
But many general practitioners - who write the vast majority of buprenorphine prescriptions - lack experience in addiction treatment. While some belong to voluntary networks that sponsor occasional education sessions and include specialists trained in addiction medicine, most GPs do not.
According to doctors and addiction experts, some physicians have mistakenly prescribed buprenorphine as a treatment for marijuana use, potentially creating new Subutex addicts. Others have prescribed it in dangerous combinations with sleeping pills and tranquilizers.
Dr. Alain Morel, a psychiatrist at Le Trait d'Union, a drug treatment center in the Parisian suburb of Boulogne, thinks general physicians should be trained, certified and permanently "attached" to a drug clinic to prescribe buprenorphine. Many, he said, "don't do any follow-up, so it's up to the patient to use - or misuse - the drug."
Some countries put more trust in patients than others, and it shows in their different take-home policies. Doctors could prescribe 28 days worth of pills at the outset of the French program. Although abuses led the government to tighten the take-home recommendation to a week's worth of pills, doctors are allowed to prescribe more.
The United States has a fairly permissive take-home policy, letting doctors prescribe at least a month's supply, among the largest anywhere. By contrast, in Germany unsupervised dosing is not the norm. There, some patients are permitted a week's worth of take-home doses but only after showing compliance for six months.
Finland allows up to eight days of take-home doses once a patient has become stabilized. After Finns were found to be traveling to Latvia or Estonia to obtain Subutex, those Baltic countries introduced new restrictions. Estonia, for example, allows one to two weeks' worth, depending on a patient's dose.
In France, illegal sales persist despite law enforcement efforts. Over the past year, police have arrested 30 people in a Subutex ring, including a Tunisian man who had nearly 40 prescriptions for the drug. They were from the same doctor, about half filled out in the name of a single patient, said Commissioner Roland Desquesnes of the Brigade des Stupefiants, the anti-drug unit. The physician, who was among those arrested, had sold them for $30 to $45 apiece.
France is also an international hub of Subutex trafficking, a source of the drug in Finland, Georgia and the Czech Republic, according to officials in France and in several countries.
"I think that some percentage of [France's] Subutex comes straight to our country," said Khatuna Todadze, director of a methadone maintenance program at the Georgian Institute of Addiction. "Our problem depends on their system. It's too liberal. Maybe it's good for their patients, but it must be more controlled."
Authorities in Mauritius say they have traced large amounts of illegal Subutex to France, such as the 50,000 tablets brought to the island in May by a French steward for Air France.
It is a profitable trade. In France, an 8-milligram Subutex tablet costs the equivalent of $4 to $8. In Finland, it goes for at least $50. In Georgia, where experts say it has surpassed heroin in popularity, it sells for $100 or more per pill.
"It's more lucrative than heroin," said Desquesnes. "People are very interested in dealing it, and in France, it's very easy to get."
Schering-Plough, the distributor, has come under fire from critics who say it has done little to discourage abuse and illegal diversion of a drug that makes money. The company says that its employees take security seriously, and that "we control the product when it's in our hands."
The company has suggested ways to reduce trafficking, including "reinforcing surveillance" and training doctors better, according to Arens-Richard of the French Health Products Safety Agency.
"Schering-Plough is actually training a lot of doctors," she said, "but it hasn't reduced the misuse of the drug."
Lafforgue, the general practitioner from Toulouse, doesn't see buprenorphine as a solution to opiate addiction.
"We've made drug users addicted to Subutex because it calmed them down," she said. "We've cleaned up the country, but we haven't solved the problem of drug abuse."
By Erika Niedowski | Sun foreign reporter
Sun reporter Fred Schulte contributed to this article.
Reference: http://www.baltimoresun.com December 17, 2007
Better Dead Than High
The morally dubious logic of drug warriors.
For several years now, the drug naloxone has been used in emergency rooms and clinics to treat people who have overdosed on opium-derived drugs like heroin or morphine.
A new version of the drug is even more promising in that it can be administered outside of hospitals. The new version comes as a nasal spray, and retails for about $10.
Several dozen volunteers and government public health groups across the United States have begun distributing the packets to drug users, along with training on how to use it.
The results have been encouraging. One study looked at 16 organizations that have been distributing the kits, and found that they'd cumulatively trained 20,950 people to administer the drug, and successfully reversed 2,642 overdoses.
Perhaps you aren't fond of the idea of using tax dollars to help drug addicts avoid overdoses (and yes, some of the groups distributing the packets are taxpayer-subsidized). As a libertarian, I have mixed feelings.
But a $10 antidote is considerably preferable to a taxpayer-funded trip to the emergency room. The packets seem even more reasonable given that many states have been reluctant to pass "good Samaritan" laws, which shield people who call 911 to report overdoses from prosecution.
In any case, they certainly seem like a good idea for private groups and non-profits. It's a cost-effective way of saving lives.
But not everyone is happy. Dr. Bertha Madras, deputy director of the White House Office on National Drug Control Policy, recently told National Public Radio she opposes the distribution programs because—and hold on to your hat for this one—she believes life-threatening overdoses are an important deterrent to drug use.
"Sometimes having an overdose, being in an emergency room, having that contact with a health care professional is enough to make a person snap into having someone to give them services," Madras said.
Madras' reaction offers a telling glimpse into the mind of a drug warrior.
We're told that certain drugs have to be prohibited because they're too dangerous. But we should also resist efforts to make them less dangerous because doing so might encourage drug use.
It's a bizarre argument until you consider the real motivation behind it: In truth, it's not so much about the harm some drugs do; it's about an absolute moral opposition to the use of some drugs.
Even if they were completely harmless, some people simply don't like the idea that we can ingest chemicals that make us feel good.
Over the years, drug warriors from former Drug Czar William Bennett to current Czar John Walters to recent DEA Administrator Karen Tandy have defended the efficacy of alcohol prohibition. All three have called the experiment a "success," and the notion that it failed a "myth."
They insist alcohol prohibition was a success because it reduced alcohol consumption. That assertion itself is debatable, but even assuming they're right, the argument itself is revealing.
Americans didn't pass prohibition because there's something inherently evil about alcohol. They passed it because of the alleged deleterious effects associated with drinking.
To call Prohibition a "success," you'd have to ignore the precipitous rise in homicides and other violent crime during the period; the rise in hospitalizations due to alcohol poisoning; the number of people blinded or killed by drinking toxic, black-market gin; the corrupting influence of Prohibition on government officials, from beat cops to the halls of Congress to Harding's attorney general; and the corresponding erosion of the rule of law.
Of course, the 18th Amendment was passed because prohibitionists convinced the country that their movement would alleviate many of these problems. But once Prohibition was in place—and still today among its defenders—it became not about the negative effects of alcohol, but about preventing people from drinking as an ends unto itself. Stop people from drinking, and we've won. Never mind that the cure was worse than the disease.
In December 2006, the ONDCP put out a triumphant press release celebrating a five-year decline in the use of illicit drugs among teens.
"There has been a substance abuse sea change among American teens," Walters said in the release. "They are getting the message that dangerous drugs damage their lives and limit their futures. We know that if people don't start using drugs during their teen years, they are very unlikely to go on to develop drug problems later in life."
But the following February, the Centers for Disease Control reported that deaths from drug overdoses rose nearly 70 percent over the previous five years.
Half the overdose deaths were attributable to cocaine, heroin, and prescription drugs (the number of overdose deaths caused by marijuana—the drug most targeted by the ONDCP—remained at zero). One of the biggest increases (113%) came among aged 15-22, those same teenagers Walters was celebrating just three months earlier.
To look at those two figures and conclude that the drug war is moving in the right direction betrays a near-religious devotion to preventing recreational drug use, at any cost.
Prohibition advocates are again measuring success not on how well the drug war is preventing real, tangible harm, but simply on how effectively they're preventing people from getting high.
The naloxone story only reinforces in a tidier narrative what we've witnessed for the last 25 years—that drug warriors are willing to write off the loss of human life as collateral damage and engage in all sorts of morally dubious practices in order to prove their point.
That point, ironically enough, is that drug use is immoral and dangerous.
Radley Balko is a senior editor for reason. This article orginally appeared at FoxNews.com.
Naloxone, commonly called Narcan®, is a drug used to counter the effects of an opiate (i.e. heroin or morphine) overdose. It has been the standard care for emergency departments and paramedics for the past few decades. Naloxone works by binding to the opioid receptor in the brain and reversing the depression of the central nervous and respiratory systems. It “tricks” the brain into thinking there are no opiates in the body. If someone is overdosing on an opiate, administering naloxone can speed up their breathing and temporarily bring them out of an overdose.
Naloxone sends people with a habit into immediate withdrawal, which can be really uncomfortable. That person may want to go and fix again because they can’t feel the dope in their system, but using more can send them back into an overdose, since the opiates are still in their system. Reassure them that they will start to feel the dope again in about 45 minutes and their sick feeling will go away. Don’t let them use again and keep an eye on them because once it wears off they are still at risk of overdosing. Remember naloxone only works on opiates, not speed or benzodiazepines like Klonopin or Valium.
Naloxone is a non-scheduled prescription medication. While it is not currently available in the U.S without a prescription, there are dozens of harm reduction programs around the country distributing legal prescriptions of naloxone to drug users and their family and friends as part of overdose prevention and education.
Naloxone saves lives. If you or your friends have experienced an overdose before, or at risk of an overdose, it may be a good idea to get a naloxone kit from your nearest syringe exchange program if they have it. Talk to staff about how and when to use naloxone and how you can get more if you use or lose it.
Tips On Calling 911
Many of us are afraid to call 911 when someone we know ODs. You may have had a bad experience with paramedics, or heard stories about people being arrested when the cops came. But if you don't know how to do rescue breathing and/or CPR (or don't want to), and you don't have Narcan, calling 911 may be the only way to save the person's life. Here are a few tips for calling:
When calling 911…
Quiet down the scene.
Speak calmly and clearly. The more things appear to be under control the less likely the cops will be sent.
Tell the dispatcher that the victim is unconscious and not breathing or turning blue.
Tell them exactly where you and the victim are, the address and room number. If you are outside, give them the nearest street intersection and a landmark, as much information as possible to help them get to you. If you're squatting, send someone out to the street to wait for the ambulance.
You do not have to tell the dispatcher…
Your name (give them an alias if they ask)
That it’s an overdose
Or that drugs are involved
Once the paramedics arrive, tell them as much as you know about what drugs the person was using. For many of you, hiding your stuff before anyone comes (especially anything that might have residue like cookers, cottons, empty bags, etc.) is standard practice. Be calm and respectful, let them do their job. If the cops come too, remain calm, don’t have an attitude and be as honest as you can without getting yourself into trouble.
If you're afraid of the cops, absolutely cannot stay and no one else is around…
You can still call 911! If you're on the street or in a park, calling from a pay phone is pretty anonymous.
Try to get a passerby to help before you leave.
If you are inside a building and you can do it without hurting your friend, take them into the street, or the building doorway. The easier it is for the paramedics to get to them, the better. (Remember to put them in the recovery position!)
If you can’t move your friend, you can stay until you hear the sirens get really close, then split. Just make sure paramedics can get to them: leave the door open or put a note up, etc. (Again, remember to put them in the recovery position before you leave!)
If You Have Naloxone...
1. Can you get to it? If you have to leave the victim, remember to put them in the recovery position.
2. Draw the naloxone up into the syringe.1cc of 0.4mg/mL naloxone can be enough, but you can always draw up more and administer 1cc first, evaluate and then give them another dose.
3. Naloxone can be administered into the muscle, so you don’t have to find a vein. The best places to inject are in the arm (deltoid), thigh (quadriceps), or butt (gluteus).
4. If you have an alcohol swab, clean the area, if not administer the shot anyway at a 90° angle.
5. Begin rescue breathing.
*Naloxone should kick in pretty quickly, but it could take a few minutes for the victim to come out of it. If they don’t wake up and resume breathing within a few minutes, give them a second dose.
*In the meantime, it’s important that you breathe for them.
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I thank all of you for sending me your success stories. Suboxone has truly proved to be a miracle drug for many of us. If you haven't seen yours posted under "Patient's Stories " yet, it has been because we have been busy helping people and we try to put them first, but I will be adding more very soon. I want to thank all of you for taking the time to share your life with others. It is definitely an inspiration to many stuck in the web of drug addiction. It gives them hope and we can all use a dose of "Hope"
from time to time.
We can be reached at 770-428-0871 (office) and 770-527-9119 (cellular). We have people on call twenty-four hours a day. If you can't afford to call... we will call you as soon as we receive the information. If you are new to Suboxone and have questions then we want to hear from you. If you have no family and/or friends to support you emotionally then you are even more important to us. We want you to know you are not alone.
We can all identify with what you are experiencing and we understand. We are not here to condemn you, nor judge you but to welcome you aboard and encourage you. Give us a chance to help you? I do encourage all of you to join and get involved with our Suboxone Forum. You will meet others taking Suboxone and you will know you are not alone.
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Editor: Deborah Shrira Date: March 2008