H.R. 2260 "The Pain Relief Promotion Act of 1999"

June 24, 1999 House Subcommittee on the Constitution

Testimony of David E. Joranson

Pain & Policy Studies Group

University of Wisconsin Comprehensive Cancer Center

http://www.medsch.wisc.edu/painpolicy

My name is David E. Joranson; I am a Senior Scientist and Director of the Pain & Policy Studies Group at the Comprehensive Cancer Center on the campus of the University of Wisconsin in Madison. I thank Chairman Hyde for inviting me to address the Committee on H.R. 2260, the "Pain Relief Promotion Act of 1999." In the interest of assisting the Committee, I wish to testify for information, and only in relation to the parts of the bill that amend the Controlled Substances Act (CSA). I have enclosed references at the end of my testimony, many of which are available on our website, listed above.

My knowledge of and experience with controlled substances law goes back some thirty years, to the vigorous debate and final adoption in 1970 of the CSA. Since then, I was administrative officer for the State of Wisconsin's Controlled Substances Board, during the administration of Governors Dreyfus, Earl, and Thompson. During this time, I worked with the subcommittees of Congressman Hughes and Congressman Waxman to adopt amendments to the CSA to strengthen DEA's program against diversion of controlled substances. In 1984 I co-founded the National Association of State Controlled Substances Authorities and the first State Cancer Pain Initiative, in Wisconsin. I have studied the Federal and State controlled substances laws, as well as the state professional practice statutes and regulations in great detail; I was privileged to serve for several years on the drafting committee of the National Conference of Commissioners on Uniform State Laws to revise the Uniform Controlled Substances Act for the States. I have worked with the National Conference of State Legislatures, many state regulatory agencies, and the Federation of State Medical Boards of the U.S. All of these efforts have been devoted to achieving a 'balanced' drug control policy which is envisioned by the United Nations Single Convention on Narcotic Drugs, 1961, i.e., a policy which prevents the abuse of drugs without interfering with their medical use, in particular for the relief of pain and suffering.

Mr. Chairman, it is essential for all of the parties who are interested in the subject of this hearing to be aware of what the CSA is intended to do, and what it is intended to avoid. The CSA is an anti-drug abuse, law enforcement statute, administered by the Attorney General (AG). On the other hand, the Congress in 1970 spelled out as fundamental principles that define the relation of the CSA to medical and scientific decisions, to the Federal Food, Drug and Cosmetic Act (FFDCA), and to State laws.

(1) Medical and scientific decisions. The Congress decided in 1970 that medical and scientific decisions, such as those relating to the evaluation of drugs being placed in the schedules of the CSA, are the responsibility of the Secretary of the Department of Health and Human Services (DHHS), not the AG (See Section 811.(b) of the CSA). This fundamental principle, referred to as "balance," was established in the course of vigorous and extended debate over a Department of Justice bill that, as proposed, would have given the AG exclusive power to make decisions of a medical and scientific nature.⁽¹⁾ Congress appropriately rejected this approach. A variety of medical and scientific organizations were very much involved in helping to ensure that the CSA conveys a balanced policy; this policy has endured to this day.

(2) Relation of the CSA to the Federal Food, Drug and Cosmetic Act. The 1970 Congress determined a second fundamental principle, that the CSA is not to "be construed as in any way affecting...the provisions of the Federal Food, Drug and Cosmetic Act" (See Section 902). Mr. Chairman, it is extremely important that it is under authority of FFDCA, not the CSA, that drugs are approved as safe and effective for medical use, so that they can be marketed lawfully in interstate commerce. It is under the FFDCA, not the CSA, that drugs are scientifically evaluated and approved for various uses. Many opioids have been approved for treatment of pain, diarrhea, and cough. The fact that opioids are also controlled under the CSA does not affect their status as drugs that are legal to be prescribed by physicians. In addition, agency and court decisions have made it clear that although the Food and Drug Administration (FDA) approves drugs for marketing, it does not regulate medical practice, which is left to the States.⁽²⁾ It is true that there is a difference between legal and illegal drugs in the schedules of the CSA (i.e., the difference between schedule I and schedules II-V), but this difference is determined primarily by whether a drug is approved under the FFDCA as having an accepted medical use. Therefore, we should not expect to use the CSA to achieve recognition of the legal uses of drugs.

(3) Relation of the CSA to State laws. The third fundamental principle that was adopted by the Congress in 1970 is that the CSA is not intended to occupy areas of State laws which are within the authority of the States. This principle is stated in the CSA:

"No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together." (CSA, 1970, Section 903).

Without commenting on the matter of physician-assisted suicide itself, I think it is extraordinary to single out States with controversial policies on important societal issues, issues which are nevertheless within their authority, and then, because there is an (albeit tenuous) relation to the use of controlled substances, amend the CSA to contravene the policy of that State. This process would effectively overturn one of the fundamental principles of the relation between the federal government and the States.

Mr. Chairman, against the context of the foregoing fundamental principles which limit the scope of the CSA, I offer a few additional observations:

(1) Opioids are legal, under the FFDCA. H.R. 2260 states that opioids can be used in the treatment of pain. We already know that the use of opioids is legal for pain management under the appropriate federal statute, the FFDCA. If Congress starts using the CSA to state what is illegal, and also legal, we are ignoring one of the fundamental principles, and may set a precedent so that in the future you may be requested to consider legislation from various groups to clarify that controlled substances may also be used for diarrhea and cough, and for anxiety and Attention-Deficit Disorder (ADD).

(2) DEA has already clarified the use of opioids for pain. The DEA has made it perfectly clear in a 1974 regulation that nothing in the CSA precludes practitioners from providing opioids for intractable pain.⁽³⁾ DEA reemphasized this point again in its 1990 Physicians Manual, encouraging physicians to prescribe opioids when they are needed:⁽⁴⁾

"Controlled substances and, in particular, narcotic analgesics, may be used in the treatment of pain experienced by a patient with a terminal illness or chronic disorder. These drugs have a legitimate clinical use and the physician should not hesitate to prescribe, dispense or administer them when they are indicated for a legitimate medical purpose. It is the position of the Drug Enforcement Administration that these controlled substances should be prescribed, dispensed or administered when there is a legitimate medical need." (DEA, 1990, p. 21)

Further, DEA representatives are to be commended for their willingness to speak at pain conferences around the U.S.; the DEA, as well as major pain organizations, have also endorsed a new Model Guideline⁽⁵⁾

on the use of controlled substances for pain which we helped to draft; further, DEA has intimated that it is about to publish in the federal register a new statement that encourages the use of controlled substances for the treatment of pain.

(3) Defining appropriate medical uses in statute is a dangerous precedent. What about other uses of controlled substances - for diarrhea and cough, for ADD, for dyspnea and other symptom control? Will you have to consider legislation proposed by various medical groups to clarify other uses of controlled substances?

(4) What will the new DEA regulations say? H.R. 2260 at line 9 clearly contemplates that the AG/DEA may promulgate "regulations to implement this Act." Will the regulations (a) specify what is meant by the two conditions under which prescribing for pain management is legal (see lines 11-14), or (b) specify how the agency will decide what is meant by 'even if the use of such a substance may increase the risk of death' (see lines 14-15) as distinguished from 'intentional dispensing for the purpose of causing death?' (See lines15-19). Apart from the inherent difficulty in determining a physician's intention, a recent review showed the notion that opioids hasten death to be more myth than fact.⁽⁶⁾

Given that H.R. 2260 allows for DEA regulations in connection with new language about pain, hastening death and assisted suicide, it seems likely that the Attorney General and the DEA would be faced with decisions involving medicine and science, in direct conflict with the first fundamental principle.

(5) The potential for a chilling effect. Mr. Chairman, I would like to close with the following point. I make the assumption that this Committee and the other witnesses fully accept that pain is not adequately managed in this country, and further, that this is due, in part, to the under-use of opioid analgesics, especially, but not only, for people at the end of life. There are many reasons for this situation. One of the reasons for inadequate pain management, and what prompted me to accept your invitation to be here today, is that while many physicians still do not have sufficient knowledge about pain management, they also fear being investigated if they prescribe 'too much.' The root causes of these fears are intertwined with how drug control policy has developed in this country. The solution to the problem depends upon achieving and communicating a balanced controlled substances policy that is also understood by regulators and practitioners. I fear that the amendments to the CSA proposed in H.R. 2260 seriously upset a balance the 1970 Congress established, and which many of us have been working to achieve. I could cite a litany of historical treatises and studies to convince you that this fear exists; instead, I will name some of the organizations that have recognized that physicians' fears of regulatory scrutiny affect their use of controlled substances for pain management:

The American Academy of Pain Medicine

The American Pain Society

The Federation of State Medical Boards of the U.S.

The Medical Board of California

The National Academy of Sciences, Institute of Medicine

The National Conference of Commissioners on Uniform State Laws

The National Conference of State Legislatures

The State Cancer Pain Initiatives

Finally, Section 102 would establish an education and training program for law enforcement officials. I think that such training could be very valuable. Indeed, we have conducted eleven workshops on pain management in a regulated environment for state medical board members with support from the Robert Wood Johnson Foundation and the Advocates for Childrens' Pain Relief. One of the risks however is that such a program might digress into discussion of drug abuse rather than pain management and palliative care, and possibly result in more second-guessing of medical judgements. While it is quite positive that Section 102 specifies that the AG should incorporate the recommendations of the Secretary of the DHHS, I would suggest that the Subcommittee go further to specify that the content of such education and training, in accordance with the fundamental principle, be established by the Secretary, in consultation with the AG.

Mr. Chairman, I thank you and the members of the Subcommittee for this opportunity to testify. In sum, it appears that H.R. 2260 challenges three fundamental principles that limit the scope of the CSA, thereby unbalancing drug control policy at a time when the opposite is needed. I would urge the Subcommittee to pursue other measures that could more directly address the root causes of inadequate pain management, for all stages of life, without disturbing the sensitive balance that is needed in controlled substances policy. I am happy to take questions or provide further information.

Note: Pursuant to the Committee's instructions to witnesses, I do not have and have not had for two years any involvement with federal grants, and I am not representing any other party at this hearing.

Selected Bibliography

Alpers A. Criminal act or palliative care? Prosecutions involving the care of the dying. The Journal of Law, Medicine & Ethics. 1998; 26:308-331.

Fohr SA. The double effect of pain medication: Separating myth from reality. The Journal of Palliative Medicine. 1998;1(4):315-328.

Joranson DE. Federal and state regulation of opioids. Journal of Pain and Symptom Management. 1990;5(Suppl):12-23.

Joranson DE. A new drug law for the states: An opportunity to affirm the role of opioids in cancer pain relief. Journal of Pain and Symptom Management, 1990;5(5):333-336.

Joranson DE, Gilson AM. Controlled substances, medical practice, and the law. In: Schwartz HI, ed. Psychiatric Practice Under Fire: The Influence of Government, the Media, and Special Interests on Somatic Therapies. Washington, DC: American Psychiatric Press, 1994:173-194.

Joranson DE, Gilson AM. Improving pain management through policy making and education for medical regulators. The Journal of Law, Medicine & Ethics. 1996;24(4):344-347.

Joranson DE, Gilson AM. Controlled substances and pain management: A new focus for state medical boards. Federation Bulletin: The Journal of Medical Licensure and Discipline. 1998;85(2):78-83.

Martino AM. In search of a new ethic for treating patients with chronic pain: What can medical boards do? The Journal of Law, Medicine & Ethics. 1998;26:332-349.

Musto DF. The American Disease: Origins of Narcotic Control. 3^rd ed. New York, NY: Oxford University Press, 1999.

Von Roenn JH, Cleeland CS, Gonin R, Hatfield AK, Pandya KJ. Physician attitudes and practice in cancer pain management: A survey from the Eastern Cooperative Oncology Group. Annals of Internal Medicine. 1993;119:121-126.

Weissman DE. Doctors, opioids, and the law: The effect of controlled substances regulations on cancer pain management. Seminars in Oncology. 1993;20(2 Suppl 1):53-58.

1. Controlled Dangerous Substances, Narcotic and Drug Control Laws" Hearings before the U.S. House of Representatives Committee on Ways and Means. Washington, DC: U.S. Government Printing Office, 1970.

2. See for example Section 202 of the 1962 amendments to the FFDCA, P.L.87-871, 76 Stat 780; and U.S. vs. Evers, 1981)

3. Code of Federal Regulations Part 21, Section 1306.07(c)

4. Drug Enforcement Administration. Physician's Manual: An Informational Outline of the Controlled Substances Act of 1970. U.S. Department of Justice: DEA; March, 1990.

5. Federation of State Medical Boards of the United States, Inc. Model Guidelines for the Use of Controlled Substances for the Treatment of Pain. Euless, TX; May 1998.