Laura M. Nagel
Deputy Assistant Administrator
Drug Enforcement Administration
American Association for the Treatment of Opioid Dependence
Washington, D.C.
April 14, 2003

Good Morning. Thank you, Mark, for the introduction. I would like to thank you and the American Association for the Treatment of Opioid Dependence for the invitation to be a guest speaker at this conference. I am especially pleased to be afforded the opportunity to provide the Drug Enforcement Administration’s perspective on the treatment of opioid dependence. The DEA shares a common goal with the treatment community: to reduce the incidence of drug abuse in the United States.

During my 24-year tenure as a special agent with the DEA, I have worked in various field offices as well as at Headquarters. My current position as Deputy Assistant Administrator of DEA’s Office of Diversion Control has been both challenging and rewarding. It has broadened my understanding about many complex issues such as opioid addiction and its treatment, and has allowed me the opportunity to collaborate with healthcare professionals such as you.

In 1970, the Controlled Substances Act was enacted and gave the DEA the responsibility to prevent, detect, and investigate the diversion and abuse of controlled substances, and eventually, List I chemicals.

The role of treatment providers is similar to that of the DEA in that each of us has a goal to reduce drug abuse. However, you achieve your mission through therapeutic interventions that address the needs of the individual patient experiencing opioid dependence. Your work is often done in less than optimal circumstances with many barriers and little recognition. You see the whole person and you do what is humanly possible to help them succeed. I have enormous appreciation and respect for the difficulties and accomplishments of the treatment community.

DEA believes that maintaining compliance with existing laws enhances the benefits of the therapeutic environment. The proper handling of controlled substances by treatment providers protects the health of patients, improves the quality of treatment, and safeguards society against drug abuse and diversion.

DEA supports expanding access to treatment services and increasing the quality of care received for opioid dependence. DEA has been an active participant in developing responses to these new directions in policy, regulation, and law by maintaining its role in establishing a balance between adequate safeguards against diversion and working within the spirit of expanding access to addiction treatment. The challenge facing opioid treatment programs and law enforcement historically is the process of providing effective treatment while preventing the abuse of the treatment drug itself. We are again faced with this challenge today with the introduction of two new buprenorphine treatment drugs.

I would now like to discuss some of the problems that drug abuse creates, then talk a little about what the DEA is doing to enforce the controlled substances laws, and finally talk about some of the ways we can collaborate to ensure that new treatment opportunities and expanded access to treatment are effectively utilized.

Let me begin with the dimensions of the problems of drug abuse by offering a few statistics –

• According to the Office of National Drug Control Policy, each year, roughly 20,000 people die of drug-induced causes. This does not include the additional tens of thousands of people who die from drug-related events – such as traffic accidents and homicides.
   
• About 600,000 hospital emergency room mentions a year were reported in DAWN by people whose visits resulted from the use of illicit drugs or the non-medical use of licit drugs.
   
• Crime and drugs use go hand-in-hand. The Arrestees Drug Abuse Monitoring program reports that roughly two-thirds of male arrestees test positive for illicit drugs.
   
• In 2001 it is estimated that 94 million people had used an illegal drug at some point in their lives. Today, some 16 million people are using illicit drugs at least once a month -- about seven percent of the population.
   
• The National Household Survey on Drug Abuse reports a significant increase in "past month, non-medical use" of pain relievers among those age 18-25 when comparing 2001 data with that for 2000.

As these statistics illustrate, much work remains to be done toward resolving the problems of drug abuse. What America really needs is an honest effort to integrate prevention, treatment, and enforcement. Toward this goal, the DEA is pleased to join our partners in the medical and treatment community to help restore the lives of those struggling with opioid addiction, while ensuring the integrity of our systems.

DEA’s mission is to disrupt and dismantle drug trafficking organizations. We direct our efforts in three areas – the international arena, at the national level, as well as working with our local communities.

Most of the illicit drugs consumed in the U.S., such as cocaine and heroin, are grown and processed entirely outside of our borders. The worldwide drug trade is estimated to be about $400 billion a year. The drug trade in America is estimated at $65 billion a year. The fight against drug trafficking, diversion, and abuse transcends world politics. The DEA supports international investigations by sharing intelligence, training foreign law enforcement personnel, and developing common strategies. DEA works with our law enforcement partners to target, disrupt and dismantle those trafficking organizations responsible for the importation of these illicit drugs.

In the national arena, DEA targets dealers that are often tied into regional, national and even international distribution organizations of illicit drugs. A single DEA operation, aimed at one drug gang, might also target activities in 10 or 20 cities around the country. At the same time, there is a large illicit market for legitimately manufactured drugs, such as OxyContin® and methadone. These investigations present a unique problem for law enforcement as well as the medical community.

In the local communities there are occasions when drug trafficking gangs have simply overwhelmed small communities. The violence that plagues some of our small towns and rural areas are most frequently related to drug trafficking and drug abuse.

Our communities deserve the benefits of our close cooperation. We realize there are certain areas in your work in which a collaboration with law enforcement and regulatory agencies may not be desirable. And we respect that. But I believe that there are areas in which we can comfortably combine our different talents and experience, where we can work together.

The face of opioid addiction treatment has been changing at a rapid pace with the employment of various new strategies. These innovations are needed to allow the people who are opioid dependent have access to the treatment they need.

The Drug Addiction Treatment Act was passed by Congress in October 2000, waived the requirement for a separate DEA registration as a opioid treatment program for practitioners who dispense or prescribe FDA-approved Schedules III-V narcotic controlled substances for use in maintenance or detoxification treatment. DEA and the Center for Substance Abuse Treatment worked jointly to develop a system for processing these waivers, which allow physicians to provide addiction treatment in an office-based setting, thus expanding access to treatment. To date, DEA and Center for Substance Abuse Treatment has issued 1,355 waivers.

In October 2002, the FDA approved two new buprenorphine drug products for use by physicians in office-based settings as permitted under the Drug Addiction Treatment Act. I’m also told that they will eventually be available to opioid treatment programs.

The DEA supports many of the innovations that are being adopted – some whole-heartedly, some with reservations. We support the concept of addiction treatment, including opioid treatment programs as well as office-based treatment. However, treatment must go beyond just providing a drug, it must also include the development of job skills, counseling, and other ancillary services.

The potential for diversion and abuse of methadone has always caused concern for DEA. Methadone is the most widely used treatment modality for opioid addiction. Methadone is a tool of proven effectiveness in treating heroin addicts. It has been studied more than any other treatment drug with uniformly positive results enabling many Americans to once again lead stable lives.

At the same time, methadone has been available as a pain medication since World War II, but with the recent consensus that chronic pain should be treated many physicians have begun to recognize its attractiveness as an effective way to treat pain. The increased availability of methadone, because of its attractiveness for the effective treatment of both pain and opioid dependence, has recently had an unintended effect – it has been associated by the public with death and injury.

In the last several years, methadone-related overdose deaths have skyrocketed.

• According to a North Carolina Dept. of Health and Human Services investigation, such overdoses jumped sevenfold between 1997 and 2001.
   
• In Maryland, methadone overdose deaths have increased tenfold in the last five years.
   
• In Maine, methadone was found more frequently in people who overdosed than any other drug. The Maine study found that most people who died from methadone toxicity were not involved in methadone maintenance programs. The Boston Globe reported last year that of the 26 methadone overdose deaths reported so far that year in the Portland area, only one person was a client at the local methadone clinics.

In many of these cases methadone tablets were involved. These tablets are generally used in the treatment of pain not the treatment of opioid dependence.

The diversion of opioid treatment program client take-home doses of liquid methadone continues to account for some of the methadone found in the illicit market. However, the concern we all have; what is the source of the methadone involved in these deaths and injuries? The Center for Substance Abuse Treatment is conducting a study to address this question in conjunction with several federal and state agencies (including the DEA) as well as private organizations, such as American Association for the Treatment of Opioid Dependence. We are looking forward to the results of this study to provide an answer to this question.

Whether the source of the methadone is from a clinic or prescribed for pain management, the outcome of this abuse is detrimental not only to the individual, but to society as whole –

• DAWN Medical Examiner data for 2001 shows that Louisville, KY, and Birmingham, AL, have the largest percentage of methadone-related deaths amongst all reported drug deaths for those cities, indicating that the problem is not limited to only large metropolitan areas. However, it should be noted that 2001 data does not include New York or Los Angeles.
   
• DEA ARCOS information between 1997 and the first quarter of 2002, shows a continued, gradual increase in the retail distribution of methadone.
   
• DAWN National Emergency Room episodes for January-June 2002, shows that methadone ranks 13th among of all the controlled substances reported. It ranks 3rd among the opioid analgesics on the list – behind hydrocodone and oxycodone. It should also be noted that the dominant form of methadone reported nationally in DAWN is now tablet.

The recent reports of death and injury from regions such as North Carolina and Maine are very disturbing to all of us. A disastrous proposition emerges if the American public loses respect for this drug and it’s proven track record in addiction treatment.

DEA’s concern regarding the security of these treatment drugs can be addressed through the treatment communities’ diligence and accountability in the dispensing of opioids. Treatment clinics and office based doctors must comply with established federal and state regulations as well as recommended practice guidelines such as those established by the Federation of State Medical Boards in collaboration with other organizations, including the DEA and the Center for Substance Abuse Treatment. Additionally, practitioners must strive to institute practices and procedures which will protect against inappropriate or illegal prescribing of opioids. Treatment providers must guard against a lack of diligence in enforcing treatment standards, and ensure patient compliance with program guidelines in order to maintain the respect for methadone and its benefits and avoid problems with the new buprenorphine drug products.

Although there has been a recent shift in the oversight of opioid addiction treatment within the United States from the FDA to the Center For Substance Abuse Treatment, the oversight role of DEA in monitoring compliance with security and recordkeeping regulations under the Controlled Substance Act remains. DEA will continue to provide this oversight and require accountability.

You could say that these are the best of times and the worst of times. It is a period of great promise – and of many pitfalls. It’s important to get this right, and we are working hard with our partners in the medical, treatment, and regulatory communities, including Substance Abuse and Mental Health Services Administration, Center For Substance Abuse Treatment, and National Institute for Drug Abuse to do just that. We want to expand access and improve treatment for those addicted to heroin and other opioids.

New buprenorphine drug products offer a great hope for conquering addictions and restoring lives. But we want to ensure that those practitioners who receive a waiver to administer, dispense, or prescribe these products are knowledgeable about them and are committed to effective, ethical treatment.

I want to assure you that DEA supports expanding access to addiction treatment, and that we want to work with you to assure that it is done right. The diversion and abuse of these treatment drugs have the potential to undermine public support for addiction treatment. The regulatory work we do is intended to help protect you from that outcome.

The point of regulation is to solve problems, not to create them. DEA's mission is to prevent diversion and abuse. We will work with you to make sure our regulations help to achieve this goal while avoiding the unintended consequence of inhibiting, or interfering with the delivery of treatment.

Success comes in many forms. It could be the teenager who chooses a drug-free life, the person who overcomes an addiction problem, or it could be the arrest of a major trafficker.

Maya Angelou said, "we cannot change the past, but we can change our attitude toward it. Uproot guilt and plant forgiveness. Tear out arrogance and seed humility. Exchange love for hate, thereby, making the present comfortable and the future promising." That is the goal we are all ultimately working toward – a promising future.

I am very pleased that you have allowed me to address you today. I look forward to working with your association's leadership and with the treatment community as we enter a very promising period in the history of substance abuse treatment.