Speech

Asa Hutchinson
Administrator
Drug Enforcement Administration
American Pain Society
Baltimore, Maryland
March 14, 2002

(NOTE: THE ADMINISTRATOR OFTEN DEVIATES FROM PREPARED REMARKS)

"DEA and Doctors: Cooperation for the Public Good"

photo - Administrator Hutchinson
Administrator Hutchinson

Coach Frank Layden
Coach Frank Layden

photo - American Pain Society Logo
American Pain Society

Good evening. Thank you, Dr. Ashburn, for that kind introduction and especially for the invitation to address the American Pain Society tonight. I have to first say what an inspiration it was to hear Coach Frank Layden speak. Frank-we do have a head coach opening in Arkansas!

Coach's message on not quitting is a powerful one. It's a message that applies-not just in the sports arena, but also in our effort to combat drug abuse. Regrettably, there are those in our country who want to give up on our fight against illegal drugs.

We are making significant progress in our fight against drugs. Drug use overall is down by 50 percent in the last 20 years. Cocaine use is down 75 percent in the last 15 years. That is progress.

Success comes in many forms. It could be the teenager that chooses a drug-free life; it could be the professional athlete or doctor that overcomes an addiction problem; or it could be the arrest of a major trafficker. This is the job of the DEA: targeting those who traffic in illegal drugs and reducing that supply.

But another critical responsibility-that you all are concerned about-is of course regulating the distribution of legal drugs to prevent their diversion into the illegal market. And it's great to be here with you tonight to talk about some challenges facing us in that area.

The last time I was with some members of your organization was in the fall at our press conference releasing our joint statement on promoting pain relief and preventing abuse of pain medications. It was a historic moment for the DEA, the American Pain Society, and the 20 other health organizations that joined together in that consensus statement.

It was important to give the American public a fuller understanding of how we are working to prevent that abuse while allowing its use for patients in need. It was critical that we let the public know law enforcement and the health community are working together. We are not at odds.

We have a shared goal of making sure that controlled substances are used only for the health and welfare of the American public. We made a commitment at that press conference to achieving a balanced approach to the prescribing and regulating of opioids. My message to you tonight is that we stand by that commitment.

And so I am pleased to be partnering with your organization, which has assumed national leadership in pain management. And I need to thank you again for the resolution you presented us in July recognizing the DEA's efforts to improve pain management.

Tonight, I'd like to discuss tonight three topics. First, your concern for the effective treatment of pain. Second, the DEA's concern about the diversion of legal drugs. And third, recent voter referendums setting medical standards.

First, let's look at your mission of effectively treating your patients' pain. You face many challenges in doing your job, and one of those that has captured the attention of the media, the Congress, and the American public is the under treatment of pain and the abuse of opioids.

photo - OxyContin
OxyContin

While OxyContin has probably received more publicity than any other abused legal drug, it is not of course the first time we've seen this kind of problem. If we go back a century and look at the beginning of our drug abuse problems in this country, we learn that, by 1900, about one American in 200 was either a cocaine or opium addict. A great number of those had become addicted inadvertently through legal medicines. These were legal drugs then because science and experience had not yet taught us how dangerous those drugs are.

But those dangers became evident and the new federal Pure Food and Drug Act of 1906 required manufacturers of patent medicines for the first time to reveal drug content. In this way, Americans learned which of its medicines contained heavy doses of cocaine and opiates-drugs they had now learned to avoid. In describing that time in our history, drug historian Jill Jones said, "America was finally understanding the very real dangers of inadvertent addiction from medical treatment. Doctors and patients alike became more cautious, understanding the addictive qualities of these drugs."

And so most people avoided these very powerful drugs that were increasingly proving to have little of their purported medical benefit, and only a lot of harmful effects. But what's interesting is what happened next. There were still people who wanted the drugs even knowing they weren't good medicine. According to Jones, there was now "a whole new group of users who purposefully pursued the pleasurable sensation of the altered state."

We have seen the same shift from unintentional use to recreational abuse to addiction. People who choose to abuse beneficial drugs like OxyContin to achieve a high. And so society and the medical and law enforcement community have been dealing with drug abuse for some time.

Now it's OxyContin. And its abuse is a serious problem, one that the public and Congress and the DEA is very concerned about. When a state like Florida reports more deaths from OxyContin than from cocaine or heroin in the first 6 months of 2001, we become concerned. When the Drug Abuse Warning Network reports that mentions for oxycodone, the active ingredient in OxyContin, were more than 100 percent higher in 2000 than in 1998, we must be concerned. When, in a 6-month period, the Boston area experienced 36 robberies of pharmacies involving the forcible acquisition of stocked OxyContin supplies, our alarm increases. And, when we discover an organized ring of criminals in North Carolina who used computers to create forged prescriptions to divert thousands of dosage units of OxyContin to abusers, we must be vigilant to reducing abuse.

And OxyContin is not the only drug that's diverted into the illegal market. Overall, the number of people who abuse prescription drugs each year roughly equals the number who abuse cocaine-about 2 to 4 percent of the population.

In light of all this, I know the medical community has become somewhat wary about the use of Oxycontin and other opioids. I know Dr. Ashburn told Congress that "Fears of diversion and regulatory scrutiny weigh heavily on the physician's mind when prescribing these medications." Other medical groups have expressed similar concerns to me.

I'm here to tell you that we trust your judgment. You know your patients. The DEA does not intend to play the role of doctor. Only a physician has the information and knowledge necessary to decide what is appropriate for the management of pain in a particular situation. The DEA is not here to dictate that to you. We do not intend to restrict legitimate use of OxyContin or other similar drugs. We will not prevent practitioners acting in the usual course of their medical practice from prescribing OxyContin for patients with legitimate medical needs. We never want to deny deserving patients access to drugs that relieve suffering and improve the quality of life.

Let me tell you when the DEA investigates the diversion of controlled substance. We do not just randomly select doctors or pharmacists to investigate. The vast majority of the time-I'd estimate about 90 percent, in fact, DEA is alerted to possible illegal activity through complaints from pharmacists, other doctors or nurses, family members, local law enforcement, or state authorities.

There's a misperception that we judge wrongdoing on the part of a doctor solely on whether he or she is prescribing high quantities of drugs. In reality, quantity alone is not an indicator of wrongdoing. We may look at numbers as a possible indicator of suspicious activity, but in the absence of other information about diversion, quantity alone is not an indication of violation.

The vast majority of doctors will never even see the DEA during their careers. In 2001, more than 900,000 physicians were registered with the DEA to handle controlled substances. During that year, we initiated only 861 investigations of physicians. We took 697 actions against violators, most of which were the surrender of DEA registrations for cause. This means the doctor was no longer entitled to a DEA number because they either were no longer licensed to practice medicine or were convicted of a drug-related felony.

Given that only a very small percentage of physicians are investigated and sanctioned, and the fact these investigations are initiated in response to complaints, a physician acting in good faith and in accordance with established medical norms should be confident in their ability to prescribe appropriate pain medications.

So let me give you an example of the kind of doctors we do investigate. Dr. Robert Weitzel was a physician in Utah who was brought to our attention through an anonymous complaint. It turned out Dr. Weitzel was providing patients with prescriptions for the Schedule II opioids Morphine and Demerol and requiring they return the drugs to him so he could administer partial quantities and keep the rest for his own use.

He even picked up drugs himself at pharmacies that he issued in patients' names without their knowledge. Many of these patients never received the medications, and some had never been treated by the doctor. Dr. Weitzel surrendered his DEA registration and pled guilty to obtaining drugs by fraud.

And so that illustrates the kind of doctors the DEA is targeting. Those who unlawfully deliver controlled substances. And let me be clear that the DEA will take strong enforcement efforts against people like Dr. Weitzel who are diverting controlled substances and who are causing such great harm.

And that brings me to the second topic I want to address tonight-the DEA's concern about diversion of drugs, particularly OxyContin. I mentioned the many abuse situations we're seeing. So, in response to the escalating abuse and diversion of OxyContin, the DEA implemented a National Action Plan. This Plan concentrates on enforcement and regulatory investigations targeting key points of diversion, including forged and fraudulent prescriptions, doctor shoppers, and unscrupulous medical professionals.

A few of the key things we're doing:

--We're encouraging the development of state prescription monitoring programs. We have found that states that have these programs in place have the lowest numbers of diversion problems.

--We're working with healthcare groups-by making presentations at conferences like this and publishing information to help practitioners better identify diversion scams and drug-seeking behavior.

--We're emphasizing education. It's critical. And that effort must come from the medical community. It should include programs to increase practitioners' knowledge regarding the appropriateness of opioid prescribing as well as the establishment of better clinical guidelines for the assessment of pain.

--We're communicating to the pharmaceutical industry our position on marketing and promotional activity. We believe 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.

And so there are many ways we can work together as we seek a balanced approach between patient care and diversion prevention.

The third and final topic I'd like to address is referendum-based medical care: Voter initiatives that attempt to set medical standards for your profession. It is clear to me that we should not allow medical issues or determinations of a drug's valid medical use to be determined in a voting booth. Medical guidelines need to be based on the best available science undertaken by medical professionals.

Several states have passed marijuana initiatives that allow doctors to prescribe marijuana for medical treatment. That's not the way it should be done. The DEA remains opposed to that, which is a position that may not be popular with some. In fact, I know it's not. I was in San Francisco last month delivering a speech to the Commonwealth Club of California. When the pro-medical marijuana crowd got wind that I'd be there, they organized a protest and had over 200 people--including the district attorney and two members of the Board of Supervisors--marching outside. Many of them came inside and heckled me while I was speaking. They strongly disagreed with the DEA's position that marijuana is not medicine, and weren't shy in letting me know that.

But we came to that decision because we listen to science. What the science has told us thus far is that there is no medical benefit from smoking marijuana. It is not recommended for the treatment of any disease. In fact, the research has shown that it can do more harm than good in people with already compromised immune systems. A study out just last week shows that long-term marijuana-smoking impairs brain function.

However, we at the DEA realize how important it is to keep listening to science. And that's why we've authorized studies with smoked marijuana in humans. Under a program established by the state of California, two researchers at the University of California San Diego are studying the safety and efficacy of cannabis compounds in humans as an alternative for treating certain debilitating medical conditions.

Another voter referendum that you all are familiar with is Oregon's "Death with Dignity Act" that was passed a few years back and allows doctors to prescribe drugs to end a patient's life. I know some in the medical community are concerned about physician-assisted suicide and the Attorney General's recent position on Oregon's law. It's a sensitive subject.

The central point in our position is that the American public must be confident that controlled drugs are used for legitimate medical purposes and will cause no undue harm to patients. And that is why the DEA has determined that drugs controlled by federal law may not be legally dispensed to assist suicide. You should know DEA's position has been challenged by the State of Oregon and is currently the subject of litigation in Federal court.

Please be assured that the DEA understands your responsibility to pain sufferers and those seeking to diminish their suffering. Physicians should not hesitate to prescribe suitable medications for pain relief, even if dosages to properly control pain entail the risk of hastening death. You should feel confident in your ability to provide appropriate pain medications to those in the last stages of life. Please know that we at the Department of Justice realize that pain management is good medical care.

photo - Mother Teresa
Mother Teresa

Thank you for your leadership. With groups like yours who are on the forefront of treating pain and who are such important advocates for the people you care for, I know we will succeed.

Mother Teresa was once asked how she was able to minister to so many thousands of sick and dying people. Her simple answer was, "One at a time." And so, you too are doing that same thing. When you identify appropriate pain treatment for a patient and help them heal and resume normal activities, you are restoring their lives. One at a time, you are finding that balance between promoting pain management and preventing abuse. That's success, and I look forward to working with you as we continue to achieve that success together. Thank you. ##

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