The OxyContin Controversy
New Painkiller Sparks Debate; Manufacturer Mounts Defense
Virginia Town Uses Fingerprint System To Track OxyContin Prescriptions

From: Common Sense for Drug Policy

Kevin B. Zeese, President -- Mike Gray, Chairman -- Robert E. Field, Co-Chairman

Pulaski, Virginia, has become the first town in the country to use a fingerprint security system to keep track of people who are receiving legally prescribed OxyContin. The Roanoke Times reported on June 11, 2001 ( "Pulaski Hopes Fingerprint System Will Stamp Out OxyContin Abuse") that "The Pulaski Police Department is providing the six pharmarcies in town with fingerprint kits. Pharmacists will ask customers requesting OxyContin prescriptions to dip their forefinger in invisible ink then stamp it on special paper. The prints will be attached to the prescriptions and kept at the pharmacy. If officers find out that a prescription has been stolen or falsified, they can identify a suspect from the prints."

The Times notes that "The fingerprint system, manufactured by the South Carolina-based company CrimeBite, is already used in several grocery stores before payroll checks are cashed. If a check comes back as counterfeit or stolen, management can find the perpetrator through their fingerprint. Lydia del Rossi, president of CrimeBite, said Pulaski is the only town she knows of that is using the invisible fingerprint system to target OxyContin abuse. Some psychiatrists in Louisiana use the system when they disperse narcotics in Louisiana. But OxyContin isn't the only drug officers are worried about. Fingerprints may also be taken before several other narcotics are administered. Pharmacists will meet with officers July 18 to decide how the kits will be used."

Attorneys in southeastern Kentucky have filed suit against Purdue Pharma. According to the Lexington, KY Herald-Leader on June 22, 2001 ( "OxyContin Maker, Others Sued By Kentucky Plaintiffs"), "The suit, filed in Clay County by attorneys Bill Hayes of Middlesboro and Peter Perlman of Lexington, is apparently the first in Kentucky targeting OxyContin. Lawsuits that make similar claims are pending in Virginia and West Virginia. The Kentucky action names five living plaintiffs and the estates of two others it claims died of OxyContin overdoses, but seeks certification as a class-action suit, creating the potential for many other users of the drug to join."

Also named in the suit, according to the Herald-Leader, are "a Harlan urologist charged in February with illegally prescribing OxyContin; and Pineville Community Hospital." The Herald-Leader reports that the doctor "allegedly prescribed OxyContin to some of the people named in the suit, and the hospital was allegedly the supplier through its pharmacy, the suit says. The lawsuit says Purdue Pharma used coercive and inappropriate tactics to market its drug; 'courted and seduced' doctors with free trips to get them to prescribe the drug; and failed to properly warn of possible negative effects."

The State of West Virginia has filed suit against the manufacturer of OxyContin and another major pharmaceutical manufacturer. According to the Charleston, WV Daily Mail on June 8, 2001 ( "WV Chosen To Participate In Project To Stop OxyContin Abuse"), "Mississippi, West Virginia and three other states have been chosen for a federal prescription monitoring and pilot program aimed at stopping abuse of the painkiller OxyContin, officials said." The Daily Mail reported:

"The Drug Enforcement Administration approached the State Board of Pharmacy about the computerized reporting system on June 1, said board executive director Buck Stevens. Stevens said pharmacies would only participate on a voluntary basis. "'We have not been asked officially and the board's directors have not given official approval,' Stevens said. 'But the DEA is moving aggressively on this OxyContin issue. They want to create a model project for the country.'" "Florida, Ohio and Virginia were also chosen to participate in the DEA project, which is in the preliminary stages. "Nationally, 16 states have prescription monitoring systems, but only two, Kentucky and Utah, are computerized."

The manufacturer of OxyContin, Purdue Pharma, "plans to pay for part of the project, said company spokesman Jim Heins. 'We're not denying there is abuse of OxyContin,' Heins said. 'But the majority of patients are not abusers. Many of these people who overdose are taking multiple drugs and drinking alcohol.'"

West Virginia is also filing a lawsuit against both Purdue Pharma and Abbott Laboratories, according to a report in the New York Times on June 12, 2001 ( "West Virginia: State Sues Drug Maker"). The state claims in its suit "that they aggressively tried to get doctors to overprescribe the drug while failing to warn of its potential for abuse. The drug has been linked to at least 120 overdose deaths nationwide."

The Atlanta Journal & Constitution reported on June 3, 2001 ( "FDA Panel Will Study Uproar Over OxyContin") that a US Food & Drug Administration panel "will meet in the fall to consider whether oxycodone, the generic name for OxyContin, and other opioids need more restrictions." Dr. Russell Portenoy, a member of the board of the American Pain Foundation and the chairman of pain management and palliative care at Beth Israel Medical Center in New York, who has been asked to serve as a consultant to the FDA panel, told the J&C: "'Because of the pervasive fear of these drugs in this country, what I would call the stigmatism of these drugs, stories about (misuse) may drive regulators and those in law enforcement to take actions that are not warranted and would have the unintended effect of reducing access to patients who need them.'"

OxyContin's manufacturer is beginning to cut back on distribution of its most powerful available formulation. According to the Washington Post on May 12, 2001 ( "Shipment Of Potent Pain Pills Suspended"), Officials at Purdue Pharma LP, of Stamford, Conn., said the company won't sell the 160-milligram OxyContin pills while it works to prevent widespread abuse, especially in Appalachia. The 160-milligram pills -- which hit the market less than a year ago -- are much more dangerous than the more common 80-milligram, 40-milligram and 20-milligram pills, and doctors said that they could easily kill a first-time user." The Post notes that "The move comes just days before a scheduled meeting of the National Association of Attorneys General, at which officials are expected to discuss ways of controlling prescription drug abuse, especially abuse of OxyContin." The effect of this move is also being questioned. According to the Post, "DEA officials said yesterday that pulling the 160-milligram pills will do little to address the growing problem, largely because the high-dose tablets account for about 1 percent of OxyContin sales and rarely have been seen on the streets."

The Federal government is urging the manufacturer "of a widely abused narcotic painkiller to limit how it distributes and markets the drug, which has played a role in more than 100 fatal overdoses in several states," according to an article in the May 1, 2001 edition of The New York Times ( "U.S. Asks Painkiller Maker To Help Curb Wide Abuse"). According to the Times: "Federal officials have also been in talks about withdrawing or modifying a claim that the painkiller, OxyContin, may be less prone to abuse than similar narcotics.
"The moves come as officials at the Drug Enforcement Administration start what they describe as the agency's first effort to curb misuse of a specific prescription drug. Previously, the agency had sought to reduce abuse of classes of drugs, but officials of the drug enforcement agency said the abuse problem involving OxyContin was so grave that it required unique action. "Terry Woodworth, a top official at the agency, said it was concerned that the promotion and distribution of OxyContin by its manufacturer, Purdue Pharma L.P., to doctors like general practitioners might have led to its wide misuse. The government has said that no prescription drug in the last 20 years has been so widely abused so soon after its release as OxyContin."

In April, the National Institute on Drug Abuse (NIDA) launched "a campaign against misuse of legally prescribed drugs." The Journal of the American Medical Association reported in its May 1, 2001 issue ( "Mixed Message on Prescription Drug Abuse"), "At a press conference announcing the effort to raise awareness about the dangers of these drugs, representatives from pharmacies and drug manufacturers joined NIDA director Alan I. Leshner, PhD, at the podium. All offered obligatory support for the endeavor, which at the moment amounts to a collection of pamphlets, Web sites, and other educational materials. Lacking any fixed agenda other than drawing the attention of the Washington media the parade of spokespersons balked at questions about the true scope of the problem and how to remedy it." The article goes on:

"'Determing illegitimate use is challenging,' said Thomas Menighan, RPh, president of the American Pharmaceutical Association. 'We can't view every patient as a potential abuser.' Leshner himself seemed to undermine the message of the rally by forcefully stating, 'Very, very few people who use prescription drugs develop addiction.' "So what exactly is the problem?  "Leshner said he is alarmed by the increasing number of people who use prescription drugs nonmedically. Data from the National Household Survey on Drug Abuse, administered by the Substance Abuse and Mental Health Administration, show the number of new abusers of prescription drugs is on the rise. In 1998, an estimated 1.6 million Americans used prescription pain relievers nonmedically for the first time. In the 1980s, the survey reported there were generally fewer than 500,000 first-time users each year. 'We're pretty confident the increase is real' and not an artifact of data collection, said Lucinda Miner, PhD, chief of science policy at NIDA. "But teasing out precise trends is difficult. "The 1999 survey incorporated major changes that make it incompatible with earlier surveys, said Jim Colliver, PhD, a NIDA statistician. Colliver also said there is confusion about the figures presented at the press conference. Leshner stated that 4 million people used prescription drugs nonmedically during 1999, while the survey report actually places that figure at 9.3 million. "The 4 million figure refers to past-month, not past-year, usage, said Colliver.

"In any case, the survey does a poor job of tracking the severity of abuse, as the 1999 report does not distinguish between fleeting and chronic users. "Of the 4 million -- or 9.3 million, depending on the time frame -- prescription drug abusers, it is unclear how many used pills once, 10 times, or 100 times."

Media reports have taken the controversy over OxyContin, the painkiller manufacture red by Purdue Pharma LLP, nationwide. Newsweek reported in its April 9, 2001 issue ("How One Town Got Hooked"), "Oxy has taken hold in other rural Appalachian states and in New England, places where it's tougher to get more familiar street drugs like heroin and crack. The drug's maker, Purdue Pharma, says it is appalled by the widespread abuse of the drug, a form of synthetic morphine. 'When this drug is used properly, it has the potential to save lives. When it's abused, it has the potential to take lives, just like any other strong medication,' says Dr. J. David Haddox, Purdue Pharma's medical director." Some even argue that the media may be fueling an over-reaction. See, for example, "Oxycon Job: The Media Made Oxycontin Drug Scare," from the Cleveland Free Times on May 4, 2001.

Authorities in some southeast US states in late 2000 and early 2001 started reporting cases involving OxyContin. According to The Roanoke (VA) Times in August of 2000, OxyContin is "becoming the street drug of choice in the New River Valley and rural areas west of Roanoke." According to a story in the Washington Post on March 14, 2001 ( "Illegal Sale, Use Of A Painkiller Alarms Officials"), "Virginia officials are considering creating a database to monitor the distribution of the prescription painkiller OxyContin amid new police warnings that Northern Virginia is becoming a clearinghouse for the illegal sale of the narcotic."

The alarm continues to mount. A story in The San Francisco Chronicle from February 10, 2001, headlined "Alarm Over Abuse of New Drug" describes how "Harried police detectives in dozens of rural areas in Eastern states are combatting what they say is a growing wave of drug abuse involving a potent painkiller prescribed for terminal cancer patients and other people with severe pain." The interest in Oxy has gone international, as the Irish Independent reports on the arrest of more than 200 people, including doctors and nurses, arising from an investigation into an Oxy ring based in eastern Kentucky.

The Boston Globe reported on March 23, 2001 ( "Painkiller Tears Through Maine"):
"OxyContin was first sold in late 1995, and now tops $1 billion in annual sales, outpacing the impotence drug Viagra. The pill is popular because of its time-release mechanism that slowly pumps its soothing, numbing effects over 12 hours, whereas most painkillers require multiple doses throughout a day. But crush the tablet and snort it, as addicts do, and its power is unleashed in a single, euphoric wallop. "The transition from patient to addict, whether voluntary or not, is happening with alarming regularity, authorities say." The Globe quotes Matthew Erickson, an assistant attorney general in Maine who investigates drug crimes, to explain the difficulty in this issue: "My dad was in an automobile accident a month ago and was prescribed OxyContin. It's a wonderful drug when used appropriately. The whole issue is complicated for that reason."

The manufacturer of OxyContin, Purdue Pharma L.P., has mounted a defense of their product, including this Statement on Diversion of OxyContin Tablets.

Meanwhile, concerns are growing over misuse of the codeine pill Vicodin. A number of entertainers have reported use of the drug, most notably the rap artist Eminem, but also Friends star Matthew Perry. As Time Magazine noted on March 19, 2001 ( "The Latest Trendy Drugs Are Old-Fashioned Painkillers"), "The trend has quickly spread from Hollywood to the heartland." The magazine reports that "Last month Ventura County, Calif., issued a grand jury indictment alleging that Hell's Angels used a youth gang called the Outfit to sell more than 700,000 Valium and Vicodin tablets throughout the region -- all supplied, according to the charge, by an Air Force clinic employee. But you can also ask your doctor for the pills, and he may not scrutinize too carefully the validity of your request."