An Addiction Expert Speaks Out Against
The "Chilling Effect" of the DEA on Chronic Pain Care
and Their Practicing Medicine without a License
Senator Ron Wyden
516 Hart Senate Office Building
Washington, DC 20510
Dear Senator Wyden:
I have been following the debate on the Pain Relief Promotion Act with interest and concern. As a physician who is recognized by my peers as an expert in the treatment of pain and of addiction medicine, I see people in excruciating pain every day; as a specialist in pain management, I lecture across the country on this subject and on regulatory matters associated with the treatment of pain; as a person who has been a chronic pain patient for several years due to an automobile accident, I know first-hand the difference that effective pain management can have on quality of life. For all these reasons I believe the Pain Relief Promotion Act (in its original version or the amended version passed out of the Senate Judiciary Committee) would be a threat to the proper treatment of pain across the country.
As you are well aware, the treatment of pain is woefully inadequate in our country. No one is blameless for this state of affairs — the medical schools have not devoted time to the subject, individual physicians have not taken the time to learn about the issues, state medical boards have not sanctioned physicians who under treat pain, health care facilities do not regularly assess pain levels, and actual or perceived regulatory scrutiny has kept physicians from adequately prescribing controlled substances. People do not need to suffer with pain, but the sad fact is that approximately half of those with chronic malignant or non-malignant pain or pain at the end of life do experience significant levels of pain which can be markedly decreased with pain medicines approved by the Food and Drug Administration and consistent with Federal law.
When I do my lecturing I find that one of the primary reasons for the ineffective treatment of pain is a palpable level of fear among physicians about potential loss of their state medical licenses or Federal registrations to prescribe controlled substances. I have been told on countless occasions that practitioners prescribe controlled substances in ways that will reduce the likelihood of investigation. At nearly every conference I attend or at which I present I hear at least one or two colleagues talk about their having been investigated even though they were providing proper doses of controlled substances to people in chronic pain or to terminally ill individuals who were in pain. Even though ignorance of the law is no excuse, good physicians who did not know exact Federal law related to prescribing schedule II medications have made mistakes, such as post-dating schedule II prescriptions, and have had to hire attorneys at great expense to defend themselves and fight against the threat of losing their licenses to practice medicine. The medical profession and government have done an inadequate job of educating physicians about the laws in prescribing schedule II medications. Thus, education should be the goal of all official organizations, not punitive actions. The Drug Enforcement Administration (DEA) is not the enemy, but lack of education is certainly the enemy -- with plenty of blame to go around.
As an example of the type of education that it necessary, consider the misunderstanding of physical dependence in a chronic pain patient who is being treated with controlled substances. When treating people with pain, the standard of care is to titrate the opioid to effectiveness with the goal of decreasing symptoms and increasing function given the reality of the person's clinical problem. For example, physicians do not ration insulin or call it "insulin-addicted diabetes." Everyone must be informed that there is a difference between a patient who has the disease of addiction and who is addicted and physically dependent on their drug of choice and a pain patient who is being treated with opioids for a painful physical condition and who becomes physically dependent on these medications, which is a natural, physiological consequence of the use of opioids and is not the same as addiction.
However, because of a lack of education and physicians' concerns about the role of the DEA, there is some confusion in the medical community about what the DEA is supposed to be doing. The DEA's stated purpose is to prevent the diversion of pain medications to the street and to put "script doctors" out of business. Law enforcement, not the practice of medicine, is the purpose of the DEA. Therefore, in order to respond to the comments and concerns by physicians, I asked the DEA to send me a letter I could use in the syllabus of a course called "Pain and Addiction: Common Threads" which is a day course that was part of the American Society of Addiction Medicine's Annual Medical Scientific Conference on April 6, 2000. I co-chaired this conference. I also received permission form the DEA to distribute the letter I received concerning the laws in prescribing schedule II medications. The letter has been very helpful and is even posted on the website of the American Society of Addiction Medicine (https://www.asam.org). One part of it may be of special interest for you given some of the discussion about the Pain Relief Promotion Act and the roles of the DEA and state medical boards in defining and regulating the practice of medicine within a state's borders:
... The Controlled Substances Act does not set standards of medical practice. It is the responsibility of individual practitioners to treat patients according to their professional judgement for a legitimate medical purpose in accordance with generally acceptable medical standards.
As you know, state boards of medical examiners establish standards of medical practice and regulate such practice by doctors and other practitioners in their states. Many states have undertaken actions to develop guidelines for pain treatment.
In addition to states developing resources for physicians, several different organizations have promulgated guidelines. I am currently a member of a liaison committee made up of the American Society of Addiction Medicine, American Pain Society, and American Academy of Pain Medicine to develop a set of definitions of addiction, physical dependency, and tolerance for the management of pain in patients with or without the disease of addiction. Our organizations are working together to help our members deal with these intertwined issues in a productive and helpful manner. I believe the Pain Relief Promotion Act would hamper our efforts because it would increase physicians' fears of regulatory scrutiny. My assessment is that the what will be foremost in physicians' minds is that if a patient dies after having received controlled substances, they will be at risk of investigation and prison. The fact that the proposed legislation has a provision related to the "double effect" is too little to allay the fears of risk-averse physicians.
The Pain Relief Promotion Act will have a chilling effect on pain management for the following reasons:
- It puts government agents, such as DEA investigators, in the position of acting as physicians -- even though they have no training and would be practicing medicine without a license, which I am sure the DEA does not want to do (and which is illegal). For example, how are they going to determine in a given patient whether 10 milligrams of morphine given a half hour before death was for palliative care or to assist in suicide?
- Physicians will not take the chance that a patient will have an adverse consequence, whether it be to 6 milligrams or to 10 milligrams of morphine provided to treat pain, knowing that there is a fine line between the standard of care of good pain management and the appearance of assisted suicide or euthanasia -- especially when a government official who is not trained in medicine is making the determination.
- As self-protection the physician will give people with chronic pain or pain at the end of life acetaminophen, which obviously will not treat the pain or give them the quality of life they deserve, given the reality of their clinical situations.
As you can tell, I am passionate about being an advocate for people with pain. Therefore, I would be happy to provide you with more information on anything discussed in this letter. Having read your Conquering Pain Act I know that you care about the proper treatment of pain and that you understand these matters. I look forward to working with you in the future.
Howard Heit, M.D., F.A.C.P., F.A.S.A.M.
[Underlining inserted by Dr. Schaller]
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