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The 'bupe' fix
Promoted by the U.S. as a treatment for opiate addiction, buprenorphine has become one more item for sale in the illegal drug market
Baltimore Sun
December 16, 2007
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 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!"
Link
Promoted by the U.S. as a treatment for opiate addiction, buprenorphine has become one more item for sale in the illegal drug market
Baltimore Sun
December 16, 2007
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 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!"
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