Drug dealers have discovered that rural America is a lucrative place for them to set up shop. The high unemployment rates plaguing our rural communities guarantee a steady supply of unhappy people looking for a quick fix, and the paucity of law enforcement officials allows illicit dealers to operate with virtual impunity. Many drugs are peddled in our small towns and rural communities, but the first to gain national attention was the prescription drug OxyContin. Once drug abusers learned how to break the time-release barrier of this opioid formulation, the word quickly spread, perhaps fueled by the detailed coverage of over-zealous news reporters.

The diversion of this pharmaceutical creates a multi-layered problem. Increasing numbers of young people are becoming drug addicts, and some of these have died of over-doses. Because oxycodone is present in more than 40 formulations, it is impossible to determine the magnitude of the contribution of the diversion of OxyContin to these deaths. Also, most of the deaths involve combinations of drugs, such as alcohol and oxycodone. Nevertheless, many officials take the easy route and charge Purdue Pharma with marketing OxyContin too aggressively (as if that is a blamable offense in a market economy). Some of these officials are also ready to deny our ability to prescribe opioids to patients suffering chronic and acute pain, and others have already limited Medicaid coverage for these pharmaceuticals.

On December 11, 2001, I represented members of our profession at a hearing on the diversion of OxyContin called by Congressman Frank R. Wolf. My testimony is reproduced below.

Chairman Wolf and Distinguished Members:

I would like to thank you for requesting this hearing on the recent concerns about abuses and diversion of oxycontin. I also would like to thank you for the opportunity to enter into what I trust will be a productive dialogue on the appropriateness of prescribing opioids to treat chronic pain. While no one wants to see further diversion of this effective therapy or risk death in those who abuse these agents, we must recognize that when we improve the availability of opioids to patients who need them, we risk increasing access to members of the general public who may abuse these drugs. We must be very careful, however, not to penalize our most vulnerable patients—those who suffer acute pain from chronic conditions. Access to care for our seniors, children, cancer patients, and others with severe pain must be maintained even as we increase our vigilance in decreasing diversion.

Thus, while we consider how best to address the recent and highly publicized crisis caused by diversion and abuse of a prescription medication, it is important that we recognize the vital position opioids occupy in the management of acute and chronic painful disorders. In fact, the opioid class of medication provides the most effective treatment for moderate to severe pain and could not be abandoned without grave ramifications for countless individual patients and for society as a whole. Instead of denying legitimate access to opioids, therefore, we must seek strategies that will eliminate diversion.

Over the past decade, we have made great progress in our understanding that opioids occupy a legitimate role in the management of pain. In the early 1990’s, many members of state medical examination boards believed that it was inappropriate to prescribe opioids for nonmalignant pain. These boards went so far as to countenance the investigation of any physician who took such action. This policy instilled an undercurrent of fear into the hearts of many physicians, decreasing their willingness to prescribe opioids and leading to poor quality pain management throughout the country.

Fortunately, these inaccurate and restrictive attitudes changed as a wealth of information accrued on the efficacy of opioids, the low incidence of addiction, and their manageable side effects. Today, literally hundreds of thousands of patients have been monitored while receiving opioids, and we now know that we can improve the quality of pain care delivered to the millions of Americans currently suffering or destined to suffer from acute and chronic pain only if opioids remain part of the clinical regimen.

Numerous federal and scientific societies have evaluated the appropriateness of administering opioids as part of clinical practice. The Agency for Healthcare Policy and Research has published two guidelines on the management of cancer and acute pain, both of which incorporate the administration of opioids. The Joint Commission on Healthcare Organizations has mandated the appropriate management of pain and the inclusion of pain control assurances in the Patients’ Bill of Rights. This cannot be accomplished if opioids are withheld from the paradigm of good clinical practice. The American Pain Society and the Academy of Pain Medicine, two of the most important scientific and clinical pain societies in America, have issued a joint position statement indicating that the prescription of opioids in the management of pain is appropriate in selected cases.

Most physicians recognize, however, that prescribing opioids is not risk-free. As with many drugs, these therapies can be misused. There remains a concern about addiction and, as the current crisis underscores, about the diversion of controlled substances. There may also be occasions in which opioids are prescribed in lieu of more appropriate conservative care or of a permanent option. We must maintain constant vigilance, therefore, to assure that we are offering patients the highest possible quality care without otherwise jeopardizing the health of Americans.

Although addiction is an ongoing concern, the fact is that it occurs only rarely. While estimates vary, true addiction is thought to occur in 3-6% of the adult population. There is no reason to suspect that the prevalence of addiction is any higher in the pain clinic population or in the general medical community (where opioids are administered in a controlled setting and monitored carefully). In fact, most, if not all, of the cases highlighted by the media have involved situations in which these substances were diverted to illicit use rather than the development of addiction in patients with pain.

In addition, the development of long-acting opioids is at least partially responsible for the improved safety of these formulations—because they are not associated with immediate pain relief or induction of a “high,” they are safer for legitimate patient use than short-acting, “less potent” medications. Indeed, the instances of abuse highlighted in the media require breaking this safety barrier by converting the long-acting opioid into an immediate-release preparation through chewing or otherwise destroying the sustained matrix.

As we move forward, we need to maintain a sense of balance. We need to reassure physicians that it is legally safe to prescribe opioids in the legitimate practice of medicine, even as we investigate any who may be engaged in criminal activity. We need to assure our patients that they will continue to have access to the only medications that can help them manage their intractable pain, even as we assure ourselves that criminals are unable to divert prescribed substances for illicit use. We need to instruct our patients that selling their medications is a criminal act, with criminal penalties.

The DEA was established in 1973 to enforce the Controlled Substance Act of 1970. This Act specified as a basic premise that physicians “should prescribe opioids in the legitimate practice of medicine.” We need to assure physicians that they need not fear DEA scrutiny; rather, they must have a sense that the DEA continues to endorse the appropriate use of opioids, assuring access to our patients with pain. In return, physicians need to assist the DEA by enforcing regulations designed to control the illicit use of this class of drugs. I believe that the physician community needs to work in a collaborative manner with the DEA. This can be accomplished with an educational program that facilitates the transfer of information between individual physicians and the DEA. For example, if a patient is receiving opioids from multiple physicians, this information should be provided to the physician, not used against them at a later date. Or, if criminals are receiving opioids from physicians and diverting the substances illicitly, the physicians should not fear prosecution; rather, they should work with the DEA to provide adequate information to inhibit this behavior.

I would be happy to contribute to the development of a strategy that ensures the continuation of the appropriate administration of opioids while incorporating ways to prevent their illicit diversion and abuse.

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