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DEA
Congressional Testimony Statement
of
Purdue Pharma introduced OxyContin® in 1995 as a controlled release formulation of OxyCodone, intended for use in the treatment of chronic moderate to severe pain when a continuous, potent, narcotic pain reliever is needed for an extended period. OxyContin® contains a large amount of active ingredient compared to other narcotic products. In addition to oral abuse of the intact tablet, crushing the tablet enables abusers to circumvent the controlled release mechanism and to swallow, snort, or inject the drug for a more rapid and intense high. OxyContin® has become the number one prescribed Schedule II narcotic in the United States. Increasing abuse of OxyContin® has led to an increase of associated criminal activity. In response to escalating abuse and diversion of the drug, DEA has begun a comprehensive National Action Plan, which concentrates on enforcement and regulatory investigations targeting key points of diversion, including forged and fraudulent prescriptions, pharmacy theft, doctor shoppers, and unscrupulous medical professionals. The national action plan includes cooperative efforts among DEA, other government agencies and the medical community to send the message that OxyContin® is a highly abusable and addictive substance. Labeling changes have already resulted from these efforts. The majority of states reporting significant abuse and diversion issues do not have Prescription Monitoring Programs. DEA has initiated meetings with the National Alliance for Model State Drug Laws, the catalyst for the establishment of state Prescription Monitoring Programs. DEA requested each of the approximately 800 members the National Association of Medical Examiners to provide us with information on any OxyCodone positive deaths occurring within their respective jurisdictions. Disproportionate abuse of OxyContin® may be partially due to aggressive marketing and promotion, particularly as a less abuseable substitute for a variety of less addictive medications. Due to concern that pharmaceutical companies are now marketing to market directly to consumers, DEA is communicating to the pharmaceutical industry our belief that direct to consumer advertising of controlled substances is contrary to the public interest.
DEA is taking a measured, reasonable approach to dealing with OxyContin® and other drugs of abuse and is committed to both ensuring adequate supplies of pain medications for those with legitimate needs and protecting the public from the consequences of abuse. Chairman Wolf, Ranking Member Serrano, and distinguished members of the Subcommittee: I am grateful for the opportunity to address this Subcommittee regarding the diversion and abuse of the prescription drug, OxyContin®. Before delivering my remarks on this very important and timely topic, I would like to thank the Subcommittee for its unwavering support of the men and women of the Drug Enforcement Administration (DEA), who each day courageously carry out our mission as the nation’s lead drug law enforcement agency. Background The Controlled Substances Act of 1970 (CSA) assigned DEA the legal authority to regulate controlled substances. DEA is mandated to prevent, detect, and investigate the diversion of legally manufactured controlled substances, while at the same time ensuring that adequate supplies are available to meet legitimate domestic medical and scientific needs. To enable DEA to achieve these goals, the CSA established five schedules into which controlled substances are classified according to their approved medical use and abuse potential. Schedule I controlled substances have no approved medical use in the United States, and have a high potential for abuse. Schedule II controlled substances, including OxyContin®, are approved for medical use, and have the highest abuse potential among controlled substances approved for medical use. Schedules III, IV, and V include controlled substances that have a currently accepted medical use, and diminishing potential for abuse. The National Household Survey on Drug Abuse, which is conducted annually by the Substance Abuse and Mental Health Administration (SAMHSA), demonstrated that an estimated 1.6 million Americans used prescription-type pain relievers non-medically for the first time during 1998. SAMHSA also estimated that there were 2.6 million non-medical users of pain relievers in 1999, the most recent year for which data is available. As shown in Table 1, the Drug Abuse Warning Network (DAWN) reported that mentions for OxyCodone, the active ingredient in OxyContin®, were 108% higher in 2000 than in 1998. DAWN also reported that OxyCodone was mentioned in 2% of all emergency department episodes in 2000.
Purdue Pharma introduced OxyContin® in 1995 as a controlled release formulation of the Schedule II narcotic, OxyCodone. OxyContin® is intended for use in the treatment of chronic moderate to severe pain when a continuous, potent, around-the-clock, narcotic pain reliever is needed for an extended period of time. This controlled release formulation has an important role in the management of pain where dose administration should be limited to twice, rather than four to six times, per day. It is currently approved in 10, 20, 40, 80 and 160 milligram strengths, as shown below.
The Exponential Growth of OxyContin® Distribution Since 1996, the number of OxyContin® prescriptions has risen to approximately 5.8 million prescriptions in 2000, or approximately becoming the number one prescribed Schedule II narcotic in the United States. Prescriptions dispensed for all other common opioid analgesics (such as codeine, hydrocodone, morphine and hydromorphone) have increased 23% between the years 1996 to 2000 (refer to Table 2).
During the last two years, DEA has noted a dramatic increase in the illicit availability and abuse of OxyContin®. In 1996, DEA’s Washington Field Division joined in a multi-agency task force investigation of eight physicians in southwestern Virginia who were involved in healthcare fraud and the illegal dispensing of narcotics, including OxyContin®. One of these physicians was recently convicted of 430 counts of prescribing narcotics without a legitimate medical purpose, and he faces multiple life prison terms. In early 2000, the DEA assisted the State of North Carolina in the investigation of an organized ring of individuals who used computers to create forged prescriptions to divert thousands of dosage units of OxyContin® to abusers. While OxyContin® diversion and abuse appears to have begun in more rural areas of the United States, particularly Appalachia, it has now spread into urban areas. To date, at least fourteen States have experienced increased abuse and diversion of OxyContin®. In Pennsylvania, the DEA Pittsburgh Resident Office assisted the Pennsylvania State Police in an OxyContin® case involving a physician. This investigation has resulted in 17 arrests so far. The appeal of OxyContin® to abusers of controlled substances is the relatively large amount of active ingredient present in the product in comparison to other narcotic products, and the ability of abusers to easily compromise the product’s controlled release formulation. Contrary to the product’s intended dosage and administration, many abusers are crushing OxyContin® tablets and negating the controlled release effect of the drug. Simply crushing the tablet enables the abuser to swallow, snort, or inject the drug for a powerful heroin-like high. Unfortunately, the rapid release and absorption of the active ingredient makes the drug much more toxic when taken in this manner. Tragically, the unintended result of this practice is often a medical emergency— or even death. The growing popularity of OxyContin® as a preferred drug of abuse has given rise to an increase of associated criminal activity. Pharmacies from Massachusetts to Alaska have been targeted for robberies by individuals bypassing cash and other narcotics, and instead demanding OxyContin® by name. During the last six months, the Boston area alone has experienced 36 robberies of pharmacies involving the forcible acquisition of stocked OxyContin® supplies. Recently, a nursing home in Massachusetts had its medical staff and patients held hostage by three robbers demanding OxyContin®. DEA’s National Action Plan In response to this escalating abuse and diversion of OxyContin®, DEA has embarked upon an unprecedented and aggressive, comprehensive National Action Plan focused on a single drug product. This plan concentrates on enforcement and regulatory investigations targeting key points of diversion, including forged and fraudulent prescriptions, pharmacy theft, doctor shopping, and unscrupulous medical professionals. DEA also has increased efforts to gather necessary data to better define the scope of the problem. Such data includes information regarding OxyContin® prescriptions, deaths, emergency room episodes, thefts, treatment admissions, investigations, arrests, and forensic laboratory exhibits. DEA requested each of the approximately 800 members the National Association of Medical Examiners to provide DEA with information on any OxyCodone positive deaths occurring within their respective jurisdictions. This is to give DEA more information on the scope of this problem. As of November 1, 2001, DEA has received Medical Examiner’s (autopsy) findings, with accompanying toxicology and investigator reports, from 803 cases of OxyCodone positive deaths from 31 states. A review of this response indicated that 117 of these deaths were verified as having involved OxyContin®, with an additional 179 deaths deemed to be likely related to OxyContin®. As there is no toxicological test to distinguish OxyContin® from OxyCodone, the full extent of the damage inflicted by the abuse of this drug cannot be accurately assessed. Official figures obtained from the American Methadone Treatment Association report an increase of patients admitted to Methadone Treatment Programs as a direct result of OxyContin® abuse. Programs in West Virginia, Pennsylvania, Kentucky, and Virginia report that 50% to 90% of newly admitted patients identified OxyContin® as their primary drug of abuse. Two Virginia treatment facilities reported patient increases of 80-85% and 55%, respectively, due specifically to OxyContin® abuse. Anecdotally, a treatment facility in the southwest Virginia city of Galax, reported that, of the 291 clients currently enrolled in their program, 240 (82%) are being treated for OxyContin® abuse. That center is planning to open another facility to accommodate the influx of new patients. DEA does not intend to restrict legitimate use of OxyContin®, nor prevent practitioners acting in the usual course of their medical practice from prescribing OxyContin® for patients with a legitimate medical purpose. Federal laws and regulations do not attempt to define or set standards as to what constitutes “legitimate medical purpose” or “the usual course of professional practice,” the requisite elements of lawful prescriptions under the CSA and DEA regulations. Instead, DEA relies upon the medical community to make these determinations. One major aspect of our efforts is to work with leading authorities on pain management, such as the Federation of Medical Boards, publishers of the Model Guidelines for the Use of Controlled Substances in Pain Management, to ensure that the legitimate pain management needs of patients are adequately addressed. Last month, I met with representatives of the health care community to address this very issue. I am pleased to announce that as a result of that meeting, we agreed on a consensus statement based on the following facts:
Another component of our national action plan is a cooperative effort between DEA and the Food and Drug Administration (FDA) to pursue their jurisdictional authority in a collaborative effort to counter marketing messages that promote OxyContin® as less addictive than other opioids. In July 2001, with DEA’s support, the FDA and Purdue Pharma reached an agreement regarding labeling changes. The revised package insert for OxyContin® contains cautionary language on the drug’s abuse and diversion potential. A letter calling attention to the labeling change is being sent by Purdue Pharma to healthcare professionals throughout the country. Other issues discussed by DEA, FDA, and Purdue Pharma include providing additional information to the medical community on the proper use of OxyContin®, as well as the feasibility of reformulating OxyContin® in order to reduce its abuse potential. Purdue Pharma recently announced the development of a newly formulated version of OxyContin®, and estimates that the new formulation may be marketable in three years. DEA has initiated meetings with the National Alliance for Model State Drug Laws, which has been the catalyst for the establishment of state Prescription Monitoring Programs to help control prescription drug abuse. Existing data sources such as IMS Health Incorporated™ indicate that the five states with the lowest number of per capita OxyContin® prescriptions all have long standing mandated Prescription Monitoring Programs in place (refer to Table 3). The majority of states reporting significant abuse and diversion issues are those without Prescription Monitoring Programs.
Although Kentucky has a monitoring program, it has experienced significant problems with the abuse and diversion of OxyContin®. Officials in Kentucky reported that responding to doctors requesting checks on patients (in order to ensure they were not attempting to obtain duplicate prescriptions from different doctors) prevented them from initially taking a proactive approach to analyzing the data. Nevertheless, once a problem was noted, the data served as an invaluable tool in determining possible sources. Clearly, data collection alone is not the complete solution. Resources must be dedicated to effective analysis and utilization of the data in order for monitoring to be an effective warning system. It also is worth noting that individuals from states with monitoring programs often seek out doctors and pharmacies in bordering states to obtain their desired drugs, thereby bypassing their own state’s monitoring system. Kentucky OxyContin® dealers and users were obtaining supplies from Virginia, West Virginia, Ohio, and other states. Establishing prescription monitoring systems in more states would help resolve this problem. It is clear that the presence of Prescription Monitoring Programs plays an integral role in addressing the illegal diversion and improper dispensing and acquisition of controlled substances such as OxyContin®. Enhancing these data collection systems will provide a better mechanism to gather and evaluate prescription data, which is essential in identifying and responding to newly developing trends and patterns, and most effectively directing our investigative and regulatory resources. In support of this effort, DEA stands ready to work with this Subcommittee to improve and expand data collection efforts on both the State and Federal level. As mentioned above, DEA is also exploring the utilization of new data sources, such as Medical Examiner’s reports, to ensure that information regarding the tragic consequences of OxyContin® abuse is available as quickly as possible. The Negative Impact of Current Marketing Practices The disproportionate abuse of OxyContin® is due, in part, to aggressive marketing and promotion of OxyContin® by Purdue Pharma, who represented the product as having a lower abuse potential than other opiate pain relievers. Purdue Pharma accentuated the problem by suggesting that physicians prescribe OxyContin® as a substitute for a variety of less addictive existing medications. DEA is concerned about the issues of direct to consumer advertising of controlled substance products and the promotion of such products to the medical community. While OxyContin® has not been advertised directly to consumers, it has been extensively promoted to the medical community through numerous company sponsored activities. Unfortunately, the pharmaceutical industry has begun to advertise a number of controlled substances – including a Schedule II stimulant and several Schedule IV products – through public advertisements. This practice is contrary to DEA’s long-standing policy against such advertising. This policy has traditionally relied upon the voluntary cooperation of industry. DEA is concerned that other controlled substance manufacturers may also begin similar advertising programs. Consequently, DEA will continue to work through available avenues to communicate to the pharmaceutical industry our belief that direct to consumer advertising of controlled substances is contrary to the public interest. Products such as OxyContin® by definition have a recognized abuse potential, and any advertising of their therapeutic value should properly be directed to health care professionals. Conclusion DEA recognizes that the best means of preventing the diversion of controlled substances, including OxyContin® and all other drugs, is to increase awareness of the proper use and potential dangers of the products. DEA is taking a measured, reasonable approach to dealing with OxyContin® and other drugs of abuse, and is committed to ensuring that there are adequate supplies of pain medications for those with legitimate needs while we strive to protect the public from the consequences of abuse. Mr. Chairman, thank you for this opportunity to appear before the Subcommittee today. I would be happy to answer any questions that you or any other members of the Subcommittee may have at the appropriate time. |
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