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  1. chillinwill
    Promoted by the U.S. as a treatment for opiate addiction, buprenorphine has become one more item for sale in the illegal drug market

    There's a new narcotic on the street in Baltimore and other communities - and taxpayers helped put it there.

    The hexagonal orange pills some users call "bupe" are championed as an exceptional treatment for heroin and pain-pill addicts. Federal officials have spent millions of dollars to help create and promote buprenorphine, and are encouraging thousands of private doctors to prescribe it.

    But making buprenorphine widely available has also made it easy for patients to sell the narcotic illegally, leading to growing abuse, an investigation by The Sun found. Some people have died after misusing it with other drugs.

    Heroin addicts hardened by years on city streets, and youthful buyers in suburban and rural areas, are using it to get high - sometimes in dangerous combination with other substances - and to tide them over when they can't obtain heroin or other narcotics.

    The drug, mainly prescribed in a form called Suboxone, is intended to be dissolved under the tongue. But some abusers are crushing the pills to snort or inject buprenorphine, a dangerous practice that medical experts believed could be deterred by a chemical safeguard in Suboxone.

    Federal officials didn't anticipate such abuses when they joined forces with Reckitt Benckiser Pharmaceuticals Inc., a newly formed Richmond, Va.-based subsidiary of a British Drug company, and spent at least $26 million to bring Suboxone to market. With congressional approval, officials began rolling it out in 2003 as the centerpiece of a bold experiment to steer addiction treatment from restrictive clinics to doctors' offices.

    Suboxone holds the promise of treating addiction as a chronic health condition, like treating diabetes with insulin. The pills relieve addicts' cravings for opiates and the sickness that comes on when they stop using them. Many say the drug makes them feel "normal."

    Sen. Carl Levin, a Michigan Democrat, referred to Suboxone last year as a "miracle drug" as Congress increased how many addicts physicians can treat with it. In Maryland, health officials swiftly embraced Suboxone as a major new treatment for heroin addiction, one of Baltimore's most vexing and debilitating public health problems.

    Yet Suboxone is starting to cause some of the very problems it was created to solve. Illegal sales and abuse remain far below other abused narcotics but are on the rise, especially where the drug is most heavily prescribed. Among the newspaper's findings:

    Some patients sell a portion of their take-home pills to raise cash or buy drugs, including heroin, according to police and health officials in several states. In some cases, taxpayers are subsidizing some of this illicit trade through the Medicaid health care plan, which in Baltimore pays many addicts' Suboxone bills, often at a cost of $300 or more a month.

    The street trade has flared in New England, which has the nation's highest rate of Suboxone prescribing. In the Boston suburb of Quincy, Suboxone is "popping up everywhere," a detective said. In Baltimore, the pills sometimes called "Stop Signs" and "Subbies" have been sold near Lexington Market, Oldtown Mall and elsewhere.

    Reckitt Benckiser told the newspaper that it knew of 13 deaths since 2005 related to taking buprenorphine with other substances. The Sun identified two deaths in Vermont that the company didn't know about. One was a 30-year-old Vermont construction worker; the other was a man who worked at a ski resort. There is uncertainty about the total number of deaths, because most medical examiners, including Maryland's, have no standard test for detecting buprenorphine in overdose cases.

    Suboxone's failure to deliver on one of its major selling points - that addicts wouldn't inject it - is raising concern among doctors who prescribe the drug. In October, an advisory panel that helps Reckitt Benckiser track misuse of Suboxone said that it might ask the company to consider changing the drug's formula.

    Rolley E. Johnson, vice president for scientific and regulatory affairs for Reckitt Benckiser, said that some degree of abuse is inevitable. "Anything that has opioid-like effects, which buprenorphine does, can and will be abused by those people seeking that effect," said Johnson, a former Johns Hopkins buprenorphine researcher.

    The company wants the public to have realistic expectations. Spokeswoman Harriet Ullman said: "We cringe every time we hear people say Suboxone is a miracle or a magic bullet. No drug is."

    The drug's benefits
    Suboxone's benefits are still being assessed as more addicts receive it. Experts in addiction and doctors who prescribe it say that the drug is extremely effective in helping stabilize addicts as they go through the counseling, rehabilitation and training they often need to turn their lives around.

    Suboxone works for people "who are sick and tired of the ravages of addiction," said Dr. H. Westley Clarke of the federal Substance Abuse and Mental Health Services Administration.

    Only small numbers of patients are peddling their medicine illegally, said Clarke, director of the agency's Center for Substance Abuse Treatment, which oversees the buprenorphine program. "Diversion doesn't appear to be substantial at this point," he said of the illegal selling, adding, "It's hard to design a system that's 100 percent foolproof."

    The dangers posed by heroin and other opiates led governments in at least 40 countries to adopt buprenorphine treatment. American officials have generally followed the system in France, which for more than a decade has encouraged private doctors to prescribe the drug.

    While estimates vary, U.S. officials believe that 1.7 million Americans are addicted to opiates, and about 67,000 of them are Marylanders. Heroin addiction is a particular problem in Baltimore, where state officials estimate 30,000 addicts need treatment.

    Suboxone does not block desire for cocaine, and so it cannot be used to treat the thousands of addicts who use that drug primarily.

    For decades, methadone has been the primary medical treatment for addiction to heroin and other opiates. But its misuse by addicts and patients who take it to relieve pain has been linked to thousands of overdose deaths. To stem abuses, methadone clinics initially require addicts to appear daily for their doses.

    Buprenorphine is safer. Although like methadone it can suppress breathing, the drug has a "ceiling effect" that limits the danger of overdose even as more is consumed. That effect diminishes if the drug is taken with tranquilizers or alcohol, according to the company. Death can result in such cases.

    Officials of the National Institute on Drug Abuse helped persuade Congress that buprenorphine is so safe that addicts could be prescribed it to take home and use without supervision. Nationwide, about 6,500 doctors are prescribing the drug to roughly 170,000 patients. And the numbers are increasing.

    In New England
    So are illegal sales. Nowhere is that clearer than in New England, where Reckitt Benckiser's own surveys show that illicit sales by patients are a problem. From sparsely populated Vermont to Cape Cod and suburban Boston, the drug is winding up in the wrong hands.

    Chad Bessette, a 30-year-old construction worker, was one such person.

    Six feet 2 inches tall and 190 pounds, he was an adventurous young man who moved to Colorado shortly after graduating from Fairfax High School in northern Vermont to work on a ranch as a horse roper.

    He returned to Vermont and worked construction during the day in Burlington, partying in the city's bars at night and crashing at his father and stepmother's house.

    "Chad liked to drink. That was his thing," said his father, Art Bessette. "But when he had to work, he'd get up and go right to work."

    But on the morning of April 23, 2006, after a night of heavy drinking at a bachelor party, Bessette didn't wake up.

    The medical examiner initially found in Bessette's body a high level of alcohol and a muscle relaxer, cyclobenzaprine, but did not determine a cause of death. After learning from Bessette's family that he had taken someone's buprenorphine pill that night, the examiner ordered a test that detected the substance.

    Bessette died from "acute intoxication - combined effects of ethanol, Cyclobenzaprine (Flexeril) and Buprenorphine," the death certificate reads. The family wants answers from police about how their son got the pill, but state police will say only that the matter is under investigation.

    Dr. Todd Mandel, medical director of Vermont's substance abuse agency and adviser to Reckitt Benckiser on misuse issues, said he believes Suboxone can help many addicts. But he's concerned about the effects of illegal sales. "I don't want the initiative to backfire," he said.

    "But I have to worry."
    Doctors in New England have turned to Suboxone partly to cope with widespread prescription drug abuse. In some areas, there are few methadone clinics.

    People who buy it on the street experience different effects. Most say buprenorphine doesn't provide the high that heroin does, but it can be a potent alternative. Others use it to stave off withdrawal sickness when the heroin or pain-pill supply runs out, or when they want to take a break from those drugs.

    Clayton Gilbert, director of Evergreen Substance Abuse Services in Rutland, Vt., said, "Bupe is turning into the in thing to be on. ... Almost like a fad."

    Patients obtain extra Suboxone from doctors by complaining they need a higher dose to satisfy their cravings, said Gilbert, whose center has treated about 200 people with the drug. They also plead for large quantities of the pills to take at home, creating the potential to sell some.

    Dr. Mark Logan of Rutland said 102 of his 139 Suboxone patients first obtained it on the street. Many sell pills that Medicaid pays for, creating a financial incentive to stay on it, he said. One man he had kicked out of treatment for selling his dose wept because he was relying on the income.

    Logan is among doctors who randomly call in patients to count their pills. Patients who have been selling them - and therefore would come up short - pay someone to lend them replacement pills at a cost of $5 a day. In Rutland, the scheme is called "rent-a-bupe."

    Abuse is "very prevalent," said Thomas Zarvis, 53, of Rutland, who used to pay up to $20 to buy a Suboxone pill illegally and who is now taking it legally in treatment. "I know one guy who snorts it all the time."

    Doctors say some patients experiment with Suboxone by adjusting doses or taking it with other drugs.

    John J. Lakus III, 37, of Walden, Vt., the ski resort maintenance worker, died Aug. 9, 2006, from "drug (cocaine, buprenorphine) intoxication," medical examiner records show.

    Lakus' sister, Dawn Tanko, said he began Suboxone treatment for abuse of painkillers, a condition of his probation from an assault conviction.

    Police near Boston say that the drug appeals to a wide variety of abusers, some in their late teens or early twenties, and that authorities are making more arrests as illegal sales increase.

    "We're seeing it as a drug of abuse," said Detective Patrick P. Glynn of the Quincy Police Department, which made seven arrests in October for selling or possessing Suboxone without a prescription.

    In Worcester, a reporter accompanying police in October witnessed three undercover buys of Suboxone within an hour near a rooming house known to authorities as a hotbed of drug dealing.

    One of the buys occurred after an informant tipped police about a man driving a van and shouting out the window, "I've got Suboxone for sale!"

    Lt. Timothy J. O'Connor, the leader of Worcester's vice squad, joked: "It's like a Red Sox game: `Peanuts! Peanuts!'"

    Police set up a buy in a nearby park, where they arrested the man. He had a prescription for Suboxone, police said, and had offered the entire contents of a pill bottle.

    Some illicit use has led to injuries to children in Massachusetts. Harvard toxicologist Dr. Edward W. Boyer documented nine instances in which toddlers had swallowed buprenorphine over the past two years. In six of the cases, he said, the pills that sent them to the hospital for treatment had been illegally obtained by parents or relatives.

    In Maryland
    Maryland is seeing more problems as the prescribing of buprenorphine increases. Slightly more than 400 doctors have signed up to treat addicts with the drug; the number of patients is not publicly known. The state and Baltimore City are investing millions of dollars in expanding access.

    Irvin Feagin, a 36-year-old recovering heroin addict from West Baltimore, first bought Suboxone on city streets last year for about $5 per pill. He sought it to make it through the "rough spots" that arose when he couldn't buy heroin.

    "The days I couldn't get $10 or $20 for heroin, I'd get bupe," Feagin said.

    He began taking the pill legally after a drug-related arrest landed him in a clinic last December. After starting treatment, Feagin encountered an addict who tried to sell him the drug outside Oldtown Mall. She told him she needed the cash to buy heroin.

    He was angered. "It's like you're selling the cure to get the poison," he said.

    Like Feagin, many addicts in the Baltimore area buy the drug illegally before receiving it from doctors or clinics.

    Maryland law enforcement officials say these sorts of sales are small compared to the volume of heroin and cocaine. But open-air drug markets - like those near Pennsylvania Avenue -- often sell Suboxone alongside the others.

    "You can buy it on the street for $15" per pill, said Tracy L.D. Schulden, director of Universal Counseling Services Inc. in Federal Hill, where Feagin continues to get treatment.

    Maryland and Baltimore health officials dismiss diversion as insignificantly small. "We're not too worried about it, and neither is the Drug Enforcement Administration," said Peter F. Luongo, director of the state's drug abuse agency.

    But last year, the National Association of State Alcohol and Drug Abuse Directors - Luongo's peers - said that states should develop procedures to minimize and monitor diversion and abuse of the drug.

    Federal agencies don't know the full scope of illegal sales and abuse, and they have not sounded any alarms. Tracking systems used to assess the impact of large-scale activity involving heroin, cocaine and pain pills such as OxyContin aren't geared to pick up on trafficking and deaths arising from a new street drug being sold in comparatively small amounts.

    In March 2006, the Substance Abuse Mental Health Services Administration noted "a few as yet uncorroborated anecdotal reports of possible diversion in certain localities." Yet by then some states had spotted problems.

    The Maryland Poison Center said in April 2004 that the drug was being sold on the street, mostly to heroin addicts. Ohio researchers learned in 2005 that some users compared the buprenorphine high to that of heroin.

    Testing difficulties
    A big gap in the government's knowledge comes from its inability to accurately tabulate deaths related to buprenorphine abuse. Such deaths are a key measure of misuse of a medicine, but many state medical examiners and laboratories don't routinely test for buprenorphine in cases of apparent drug overdoses. Most lack the equipment to do so.

    As more examiners become aware of the dangers of taking Suboxone with other substances, they're sending blood samples to labs with the right equipment or making plans to buy their own.

    "We can't monitor what's going on. It's a black hole of information when it comes to buprenorphine," said Seattle epidemiologist Caleb Banta-Green.

    Maryland Chief Medical Examiner Dr. David R. Fowler said he believes the state should acquire the equipment to test for buprenorphine, which would cost more than $100,000.

    National Medical Services in Willow Grove, Pa., is one of the few laboratories in the country able to identify the drug. It is receiving increasing numbers of requests from medical examiners to test for it, usually after the drug is found at the death scene or the victim is believed to have taken some. The lab has done these tests in at least 100 suspected overdose fatalities since the start of 2005 but keeps no records of the eventual findings.

    Dr. Robert A. Middleberg, chief toxicologist at National Medical Services, said the increase in test requests is "a significant change" that warrants attention.

    Middleberg's lab did the test confirming that former professional wrestler Brian Adams died from an overdose of buprenorphine and other pills. Adams, 44, died Aug. 13 at his Tampa area home. Officials did not say whether he had a prescription.

    Reckitt Benckiser, the manufacturer, tracks abuse as a condition of Suboxone's approval by the Food and Drug Administration. That effort is directed by a consultant, Dr. Charles R. Schuster, a former director of the National Institute of Drug Abuse who said he played a role in the drug's development. His company conducts periodic surveys of patients entering treatment, and of doctors, to spot trends. It also monitors news reports and Internet chat sites, particularly for signs that Suboxone is creating new drug users.

    Schuster's reports acknowledge that illegal sales have increased. But he plays down their significance.

    He said that 90 percent of street buyers of Suboxone are addicted to other substances. They use Suboxone, he said, to ward off withdrawal sickness, not to get high. That experience with the drug may encourage them to seek treatment with it, according to Schuster.

    Dr. Richard C. Dart of Denver is among experts who say that addicts seek buprenorphine for much the same reason they do other opiates. He's executive director of RADARS, a drug-industry-funded clearinghouse for four national drug tracking systems that runs out of the Rocky Mountain Poison and Drug Center.

    Dart said the system surveys doctors at treatment centers as well as patients. The surveys indicate that drug abusers are drawn to buprenorphine "in the same way" that they are attracted to painkillers such as methadone or OxyContin. Buprenorphine "doesn't set itself apart," Dart said.

    Though he described Suboxone as a "good drug" for treating addicts, Dart said that buprenorphine enthusiasts tend to minimize abuse. "To say I have a potent opiate and it can't be abused and that doesn't cause addiction, that simply is not true," Dart said.

    The Drug Enforcement Administration focuses on major trafficking in drugs such as heroin and cocaine. It relies primarily on large seizures of drugs in gauging their prevalence, and has not found anything comparable with buprenorphine.

    Nonetheless, the agency would like to receive Schuster's reports and review their findings, especially about street sales, said Denise Curry, deputy director of the DEA's Office of Diversion Control.

    Schuster's reports go to the FDA. The agency was asked to comment on abuse but did not make any officials available for interviews.

    Abuse by injection
    Treatment experts are becoming concerned about another danger associated with Suboxone abuse - injection.

    Those concerns arose in the late 1990s when injection of buprenorphine became a problem in France. There, doctors were using Subutex, a pure buprenorphine pill.

    Mindful of the French experience, U.S. officials asked the drug's manufacturer to add naloxone, a chemical that can sicken addicts who inject it. The new formulation became Suboxone.

    But naloxone doesn't always deter misuse. Acknowledging this, the company's advisory panel "is now considering making a recommendation" to boost the amount of naloxone in the pill or to add a different chemical. Panel members, who conferred in October, discussed a chemical called naltrexone that blocks the euphoria of opiate drugs.

    "We're examining this situation in every way we can think of," panel member Dr. Charles P. O'Brien, a University of Pennsylvania psychiatry professor, said in an interview. The longtime buprenorphine proponent also said panel members were "wondering if we could improve" the pill by adding more naloxone.

    Johnson, the Reckitt vice president, acknowledges that injection is occurring. He said Suboxone's original formula sought "the optimal balance between a product that would limit abuse while maximizing the clinical effect for patients." As "new scientific insights" emerge, he said, the company continues to "evaluate new product opportunities to improve the quality of care provided to opiate dependent patients."

    Naloxone's role as a safeguard was a big selling point for Congress when it considered giving physicians authority to treat addicts with buprenorphine.

    In testimony prepared for a 1999 hearing, the head of the Department of Health and Human Services said that Suboxone would have "low desirability for diversion on the street." Secretary Donna E. Shalala also cited studies suggesting that Suboxone has "very limited" euphoric effects.

    Levin, the Michigan senator, testified at that House hearing that there was "no likelihood of diversion or abuse or addiction," according to a transcript.

    He still believes buprenorphine is a "miracle drug," he said in a statement to The Sun on Thursday. Allowing doctors to prescribe it "has helped thousands of people in need of effective treatment."

    Congress passed the 2000 law that allowed doctors to prescribe Suboxone for addiction treatment two years before the Food and Drug Administration finished evaluating its safety and effectiveness. Officials found, among other things, that while naloxone would reduce Suboxone's appeal to needle users, abuse would be "by no means eliminated," an FDA document said.

    Tests done by the agency also showed that naloxone could be "degraded" and thus rendered inert, so addicts could inject the pill without suffering ill effects. The FDA found that naloxone could be filtered out by "fairly simple" methods used by "street chemists" and wouldn't prevent snorting, agency records stated.

    In the five years since the agency approved the drug, in October 2002, its predictions have come true.

    Maine's health department reported in August that misuse spread rapidly as more Suboxone was prescribed. Abusers of the drug "have figured out how to separate out the naloxone" to inject the buprenorphine, the department said.

    In Massachusetts, Glynn, the Quincy police detective, said, "A lot of people are injecting it. They're getting hooked on it." In Wisconsin, a newsletter circulated this year advised addicts how to minimize the health risks of "shooting bupes."

    The newsletter offered the information in the belief that addicts who choose to abuse buprenorphine should have unbiased information to lessen any harm such as infection. It noted that any sickness caused by naloxone is temporary.

    "There's discomfort at first, but it wears off in 45 minutes or less, and the opiate comes on," said James Reinke, who works with the AIDS Resource Center of Wisconsin office in Madison.

    Reinke's newsletter cautions addicts who inject the pills: "Start small as they are strong!"


    By Fred Schulte and Doug Donovan
    December 16, 2007
    Baltimore Sun
    http://www.baltimoresun.com/news/health/bupe/bal-te.bupe16dec16,0,2532041,full.story



Comments

  1. chillinwill
    French approach to drug offers lessons that U.S. has largely overlooked

    Dr. Jean-Pierre Aubert considers himself not only a general practitioner but a dealer of sorts.
    [IMGL="white"]http://www.drugs-forum.com/forum/attachment.php?attachmentid=11719&stc=1&d=1258900149[/IMGL]
    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.

    U.S. 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.

    Introducing Subutex
    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.

    Sufficient rush
    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
    December 17, 2007
    The Baltimore Sun
    http://www.baltimoresun.com/news/nation-world/bal-te.bupe17dec17,0,7816360,full.story
  2. chillinwill
    Not a cure-all

    Despite praise, 'bupe' alone isn't enough to break addicts of destructive routines

    [IMGL="white"]http://www.drugs-forum.com/forum/attachment.php?attachmentid=11720&stc=1&d=1258900309[/IMGL]
    Many heroin addicts trying to break the grip of drugs and crime turn to a health center on West Saratoga Street for help. Some come asking for an orange pill they believe might be a "wonder drug" for treating their problems. Nearly 200 have gotten it.

    They're among tens of thousands of addicts nationwide being treated with the buprenorphine drug Suboxone. Federal officials promote it as the best hope for overcoming opiate addiction and are encouraging thousands of doctors to prescribe the drug.

    It is the best medication for relieving the cravings and sickness of heroin use that Wendy Merrick has seen. But Merrick, who directs addiction care at the Total Health Care center in West Baltimore, says it's no cure-all. Addicts need counseling and other services to get well.

    "I never understood this whole idea that you could just give people a pill and that that is the answer to drug addiction," she said.

    The federal government equipped doctors and patients with little more than a pill when it approved prescribing buprenorphine to opiate addicts. The law doesn't require that doctors provide additional treatment - or receive much training to deal with the complexities of addiction. Nor did lawmakers authorize funds to help patients pay for the drug or additional care, costs that can quickly reach thousands of dollars.

    Even with the extra services that a substance abuse clinic offers, Suboxone patients are having a hard time shaking old habits they learned on the streets. Up to a third of Merrick's patients have been caught at one time or another using illegal drugs such as heroin and cocaine. Other city clinics and doctors elsewhere note similar patterns.

    Many patients also experience difficulty quitting the medicine, which is a narcotic. They become dependent on its effects or fear succumbing to heroin again. Lengthy use is often the norm with Suboxone, but its price becomes prohibitive the longer the treatment - especially for impoverished heroin addicts.

    "It's really tough for those people, no matter what medication you give them," said Dr. Charles P. O'Brien, a University of Pennsylvania psychiatry professor who advises Suboxone's manufacturer on tracking abuse. Habitual drug users need job skills, among other things. "If they've been using heroin for 15 years, how's a treatment program going to turn them into a taxpaying citizen?"

    The federal government had that sort of transformation in view when it approved buprenorphine in 2002 amid expectations that the drug would revolutionize addiction treatment with minimal abuse. But its wide availability is starting to create some of the problems it was meant to solve. An investigation by The Sun has found that patients are selling their prescriptions illegally, creating a new drug of abuse that some people are injecting to get high.

    Hard-core heroin addicts, like the thousands living in Baltimore, are a difficult population to wean off illegal drugs, as they typically have criminal histories, unstable families and few job skills.

    "It was never meant to treat people who live in chaos," said Dr. Erik Garcia, who treats addicts in Worcester, Mass. "It was meant to treat people who have gotten hooked on painkillers who have relatively stable lives. But the need is so huge, it ... outstrips the capabilities of the methadone clinics."

    Methadone continues to be seen by many experts as the best replacement medication for heavy-use heroin addicts. Most of the 170,000 people being treated with Suboxone in the United States are pain-pill addicts who often have more resources to help them recover.

    But Baltimore Health Commissioner Dr. Joshua M. Sharfstein says he believes heroin addicts also can benefit from Suboxone, especially if they get extra support. He enlisted six addiction treatment clinics to become the first stops for hundreds - and eventually perhaps thousands - of addicts. After being stabilized at the clinics, they can transfer to private physicians.

    Vermont and some counties in Pennsylvania are also using a clinic model. But the vast majority of addicts in Maryland and other states aren't taking this more comprehensive route to Suboxone treatment.

    Whether they get Suboxone directly from a doctor or at a clinic, addicts face similar challenges.

    The clinics in Sharfstein's program have been able to transfer to private doctors only 122 of 653 addicts receiving Suboxone. One reason is that so many keep using drugs. Another is lack of health insurance.

    A third to a half of the buprenorphine patients in the clinics have been flunking urine tests, indicating that they have been taking illegal or unauthorized drugs. People treated with Suboxone do no better or worse than addicts on any other type of treatment, clinic directors say.

    Merrick said abstaining from illegal drugs is a significant sign that patients are committed to treatment. "If the goal is recovery," she said, "you can't fill the program up with people who don't want that."

    It's not just heroin addicts who have trouble staying clean. Dr. Mark Logan of Rutland, Vt. prescribes Suboxone mostly to people addicted to the pain pill OxyContin. He said he had to kick out 45 percent of 139 patients for abusing other substances or selling their Suboxone on the street.

    Addicts often seek Suboxone for its ability to eliminate withdrawal sickness that accompanies opiate use, Logan and others said. But without those painful physical consequences, addicts are less motivated to stop using those drugs while on Suboxone.

    The goal is to minimize relapses, building addicts' confidence in their potential to quit illegal drugs. If it takes months or even years of Suboxone treatment, that's acceptable, some advocates say.

    "The longer they're on it," Sharfstein said, "the better."

    But critics say such treatment merely substitutes one narcotic for another. In Baltimore, recovery centers that emphasize a drug-free approach are balking at a state proposal to require them to accept patients using Suboxone or methadone - or risk losing state funding.

    "Individuals can lead useful lives without the need of a mood-altering drug," an official of Gaudenzia Inc., one of Maryland's largest residential treatment programs, told state lawmakers this year.

    Some recovering addicts also worry about becoming hooked on buprenorphine.
    [IMGR="white"]http://www.drugs-forum.com/forum/attachment.php?attachmentid=11721&stc=1&d=1258900309[/IMGR]
    Valarie Clark has been taking Suboxone for a year under the supervision of Merrick's Total Health Care center. She calls it a "wonder drug" for having helped her kick a heroin-snorting habit of two decades.

    Clark, 52, began using heroin in her 30s. Her drug use spiraled after her daughter died while having a baby in 1994. She unsuccessfully tried methadone treatment, saying it didn't stop her heroin cravings the way Suboxone does. She learned about Suboxone's effects after buying it on the street.

    Now her goal is to stop taking Suboxone by February. The doctor she sees at the clinic has tapered her dose from 8 milligrams a day to 4 milligrams. Having twice used heroin while in treatment, Clark is wary of relapsing, especially since she has landed a job.

    "I'm an addict, I have to be careful of all drugs, even Suboxone," she said. "At this point, I feel that it's becoming an abuse for me."

    Many doctors said patients can quickly relapse when they stop Suboxone. That in turn brings on mild withdrawal and cravings for opiates. That's why doctors try to lower the daily dose over several months.

    But getting patients off Suboxone's lowest dose of 2 milligrams is challenging. Some experts say it's a psychological barrier, others say it's physical.

    "The biggest problem is how do we get you off [the drug] - I think it's a very real problem," said Dr. Sharon Levy, medical director of the Adolescent Substance Abuse Program at Children's Hospital in Boston and a Harvard University pediatrics professor. The program prescribes Suboxone to teenage addicts.

    Yet Levy said any worries about dependence are offset by the progress that patients experience by not using heroin. "I'm struggling to get them off," she said, "but they've had two years of being off of drugs and graduating high school."

    The same clinic trying to help Clark stop taking Suboxone also has patients like Lorraine Keating, who wants to remain on the drug for the foreseeable future, because she's "nervous" about falling back into heroin use.

    "My life has really changed dramatically," said Keating, 55, of West Baltimore. She had been arrested numerous times for drug-related charges before starting the 24-milligram dose of Suboxone that she has been on since Jan. 23. She hasn't been arrested since beginning treatment at Total Health Care.

    Helping patients with varying drug habits, such as Clark and Keating, can challenge even experienced doctors. But Congress required only an eight-hour training course covering how the drug works, addiction issues and counseling methods. Lawmakers did not want to meddle in the practice of medicine, and heeded the advice of federal health officials eager to make it easy for physicians to qualify to prescribe Suboxone.

    Dr. Daniel R. Howard, who runs a private family practice in Baltimore, said he found the eight hours of training "helpful," but he wanted additional assistance and sought a mentor.

    "I felt like I needed a little more guidance in dosing," said Howard, who has treated about 120 patients with Suboxone.

    Dr. Karl Spector of Bel Air, an internist, has treated nearly 400 patients with Suboxone since February 2003. He said the training is "not enough" and determined that the manufacturer's guidelines for doses and duration don't meet everyone's needs. "I find that patients can determine what is the right dose for themselves," he said.

    Woody Curry scoffs at the eight-hour requirement.

    Curry's a certified addiction counselor who runs Baltimore Station, a 200-bed, two-year residential treatment program that relies on 12-step philosophies, counseling and employment development. He said doctors should have as much experience as counselors, whose certification can require up to eight years of training.

    MedChi, the Maryland State Medical Society, provides the training course. While it's available online, many doctors prefer to take it in person. "They have a lot of questions," said Elaine Gisriel, buprenorphine project coordinator for the group's Center for a Healthy Maryland.

    A new experience
    Treating opiate addicts is a new experience for many doctors. Addiction care had been reserved mostly for methadone clinics, before Suboxone's approval. "It's a revolution really to bring addiction treatment back into the medical mainstream," Gisriel said.

    Federal law also requires doctors to recommend additional treatment to their patients, such as counseling.

    But the law doesn't require doctors to provide it.

    The drug's manufacturer, Reckitt Benckiser Pharmaceuticals Inc. of Richmond, Va., says Suboxone works best when paired with individual or group therapy.

    "If we promote treatment, Suboxone will be a success," said Vice President Rolley E. Johnson, a former Johns Hopkins researcher who helped make the scientific case for buprenorphine's benefits in treating addiction. "If we promote Suboxone, treatment can be a failure. We believe that strongly."

    Baltimore's system is intended to provide addicts with comprehensive care as they begin Suboxone treatment. That model might also work in other areas of the state, said Dr. Peter Cohen, who is directing Maryland's rollout of buprenorphine.

    He's asking county drug councils to devise plans for tailoring treatment to their specific populations. As in Baltimore, patients could transfer to the care of doctors after being stabilized in clinics.

    "Buprenorphine is not the miracle drug," Cohen said. "But with really good treatment, you can save a lot of people's lives."

    Meanwhile, many addicts are entering treatment directly with private doctors, as federal officials envisioned. Howard said he refers his patients to support groups and other programs but is not sure that's absolutely necessary.

    "I try to pick patients who are committed to recovery and that are compliant," he said.

    He prescribes Suboxone to patients he has treated for other conditions and makes them sign contracts promising not to abuse other drugs.

    At the same time, Howard conducts urine tests to determine compliance. He immediately begins to wean patients off Suboxone if he catches them taking tranquilizers with it. Patients who are caught abusing other substances, such as cocaine, get three chances.

    He has 13 patients on Suboxone now, but over the past year he has treated about 35. And nearly 15 have failed urine screens.

    Howard's Suboxone mentor is Dr. Michael Hayes, a Baltimore addiction specialist and buprenorphine proponent. In addition to sharing his knowledge of appropriate treatment, he warns of deceit by addicts.

    "Let nobody think that all of a sudden heroin addicts become choirboys," said Hayes. He booted two Suboxone patients from his practice after learning they got narcotic pain pills from another doctor - a practice called "doctor shopping."

    "It looked like they were selling them," he said. "That was a scam."

    Logan of Vermont has limited his patients to people who, among other things, have completed a 28-day detox program and are over 30 years old. "I think it's a much smaller population that we can be successful with," Logan said.

    Doctors acknowledge that inexperience can lead to "lax or inappropriate prescribing," according to a survey of physicians done for Reckitt Benckiser. The company's advisory panel has discussed whether doctors should be urged to refrain from prescribing until they know their patients well.

    The cost factor
    Suboxone's price is another challenge for doctors and patients. The federal Substance Abuse and Mental Health Services Administration said in a March 2006 report that the "high cost of the medication" was a "significant barrier to obtaining and continuing" treatment.

    Howard said in his practice the expense "ends up being a pretty big issue. I've had patients who have asked to come off the medication because of costs."

    Many of his poor, mostly working-class patients must pay with cash because they don't have insurance.

    Spector, the Bel Air internist, said he gives his patients up to two months' worth of refills to help them avoid paying for frequent office visits. Otherwise, he said, "They try to get off of it too soon because they feel pressure financially."

    A month's worth of Suboxone can cost $300 or more, depending on dose and the price charged by the pharmacy. That doesn't include doctors' fees and charges for any other treatment. In all, Sharfstein said, a patient under the care of a private physician might pay an average of $500 a month, or $6,000 a year.

    But those costs are less than what an addict might have to pay for heroin, Howard and Spector say.

    Addiction experts worry that without subsidies, Suboxone could be unaffordable. Chris Kelly, president of the Washington chapter of Advocates for Recovery Through Medicine, termed buprenorphine "methadone for rich people."

    Johnson of Reckitt Benckiser said the company has pushed for state Medicaid coverage and broader insurance coverage to widen access. "We don't want to see a two-tiered system," he said.

    The company provides the medicine for free to a limited number of patients whose doctors recommend them, according to a spokeswoman.

    Baltimore has spent close to $1 million to ensure that patients receive buprenorphine. Another $725,000 has come from a state medical coverage plan for low-income adults across Maryland. Last week, a legislative committee authorized $3 million sought by Gov. Martin O'Malley to help local officials develop their own programs, recruit doctors and cover medication costs.

    Sharfstein said that in addition to finding funds, his priority has been recruiting addiction professionals and physicians.

    As he put it, he has been the "Johnny Appleseed of getting doctors to prescribe or be interested in buprenorphine."

    Now he's lobbying Rep. Elijah E. Cummings of Baltimore to introduce legislation to allow physician assistants, nurse practitioners and doctors in residency to prescribe it for addiction treatment.

    "It really is the beginning. We're rushing out," Sharfstein said. "I think it's way too early to declare what we're doing a success, and it's way too early to declare it a failure."


    By Doug Donovan and Fred Schulte
    December 18, 2007
    The Baltimore Sun
    http://www.baltimoresun.com/news/nation-world/bal-te.bupe18dec18,0,799409,full.story
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