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Saint Louis Brief Magazine

Relieving the Pain

Making Marked Changes to the Way Pain is Treated
Through Research, Education and Policy Changes

By Professor Sandra H. Johnson

Relieving the Pain

"He is your son. You love him. You want to help him in every way you can, but when he is in that kind of pain, you are helpless. . .I'm his daddy. . .what was I supposed to do for him? I felt, you know, helpless."

"I am a forty-six-year-old registered nurse who specializes in oncology care and education. I am also a patient who suffers from chronic nonmalignant pain, and this malady has been the most frightening, the most humiliating, and the most difficult ordeal of my life. . .The general tenor of the medical advice that was given to me was this: I would just have to learn to live with the pain. . .I found myself begging, as though I were a criminal. Defensive and angry and yet in such great need, I would beg forgiveness for having this pain. I became withdrawn, completely disabled by my terrible, relentless, pain. I was unable to function professionally. I was unable to be much of a wife or a mother, a daughter or a friend. . .Now when I see unnecessary suffering caused by intractable, "mismanaged" chronic pain, I am disgusted. As a health care provider, I am ashamed."

Saint Louis University School of Law have been working to make a difference for persons, like those whose stories are told above, who are suffering pain that can be treated and relieved. They have been a critical part of a national effort to analyze, and change, legal barriers to effective pain relief. This national effort is housed at the American Society of Law, Medicine & Ethics (ASLME) in Boston and funded by the Mayday Fund, a private family foundation in New York.

Research done by Saint Louis University School of Law students, as part of this project, has resulted in legislation in several states and in the adoption of model guidelines for state medical disciplinary boards by the Federation of State Medical Boards. School of Law faculty have also contributed by providing peer review for over a dozen individual research projects by scholars across the nation focused on legal, regulatory and financial obstacles to effective pain relief.

Why Law Students?
Certainly, the reasons for our wholesale neglect of patients in pain are complex and divergent. For example, we sometimes view pain as a positive ("no pain, no gain") or as redemptive, and we are sometimes suspicious of those who complain of pain. Individual patients, especially older patients, resist taking pain medication out of fear of dependence, weakness or addiction. Our doctors and nurses have not received adequate training in assessing and treating pain.

One source of the problem, however, is the legal system itself. Doctors consistently reported that they undertreat pain, in part, because of fear of legal penalties. In a California survey, for example, 69 percent of physician respondents said that the potential for disciplinary action made doctors more conservative in their use of effective pain medications to the extent that those medications were controlled substances subject to regulatory oversight.

When we began our research in 1995 at Saint Louis University School of Law, in collaboration with Dr. Bob Levine at Yale Medical School and Professor Nancy Dubler at Albert Einstein Medical College, we thought that we would find that physicians held exaggerated fears of inappropriate disciplinary action for the prescription of controlled substances for the treatment of patients in pain. To the contrary, we found that the standards used by the medical boards were inconsistent with research on the effectiveness and safety of those medications and resulted in significant legal risk for doctors providing good care.

The doctors were right: the wrong standards were being used. The legal research done by Saint Louis University law students documented the problem. No longer could doctors' concerns, which resulted in needless suffering, be dismissed out of hand. With that documentation and analysis, we could begin to improve the situation.

Effecting Change
The first School of Law team to work on the project in 1995-1996, including students Jonathan Fleece, '97, and Jackie Barrow, '98, did the research for and helped draft a Model Pain Relief Act that differed in several significant respects from legislation and regulations that existed at the time. Several national organizations supported the Model Act, and it became quite influential.

When the project began, only ten states had "intractable pain statutes," and only six of those addressed the issue of disciplinary actions. As of 2003, at least twenty-three states had statutes providing legislative standards or a legislative mandate that the state medical board develop written guidelines for its monitoring of physician prescribing practices so that it would be clear that inappropriate disciplinary actions would not be taken. Almost all of these new statutes provide the physician with immunity from disciplinary action that does not meet the statutory boundaries for medical board action. The statute drafted at Saint Louis University was enacted in whole or in part in New Mexico, West Virginia, Nebraska and Texas. Sometimes, legislative support for the statute, short of enactment, produced results. For example, its introduction in one particular state reportedly stimulated the medical board to adopt guidelines consistent with the Act.

The work at the School of Law also contributed to the development and recommendation of Model Guidelines for the Use of Controlled Substances for the Treatment of Pain by the Federation of State Medical Boards. These model guidelines addressed the major concerns that had been identified in our project and have been adopted by more than twenty state medical boards. They require that doctors exercise practice management techniques (including physically examining each patient, keeping good medical records, developing and updating a treatment plan and monitoring its effectiveness) that contribute both to good medical care for the patient in pain and to the reduction of risks of diversion. The Guidelines also make it very clear that physicians will not be disciplined for prescribing controlled substances for their patients when these standards are met.

Kelly Dineen, Professor Sandra H. Johnson and Femanda LimaThe Mayday Project at ASLME and Saint Louis University School of Law has evolved over time and from 1997 through 2002, the Project focused on the Mayday Scholars Program. Over that time, the Program funded more than a dozen projects focused on legal, regulatory and financing issues in the treatment of pain. Each of the Scholars presented drafts of their papers and their research results at the Mayday Scholars Workshop held biennially at Saint Louis University. School of Law health law faculty, including Eric Claeys, Jesse Goldner, Tim Greaney, Nic Terry and Sidney Watson, and scholars from other fields and other schools, provided the researchers with important evaluation of their work. The Journal of Law, Medicine & Ethics published special issues for each of the three rounds of the Scholars Program and these publications were launched with a press conference resulting in national coverage of the results in publications like USA TODAY and the BNA Health Law Reporter.

What Now?
School of Law students continue to work on important legal research in this area. The Mayday Fund is currently supporting a project at ASLME and Saint Louis University to investigate the legal, institutional and social framework that explains the neglect of pain in the emergency department. As part of a seminar on Medical Licensure this fall, Dr. Poonam Jain, a third-year law student and physician, took on the challenge of analyzing the reasons for the neglect of pain in emergency medicine and identifying whether emergency medicine is affected by the same public policies that have an impact on office-based care. Third-year law student Kelly Dineen and second-year law student Fernanda Lima both worked on a project to analyze whether the federal Emergency Medical Treatment and Labor Act required that hospitals provide emergency patients treatment for pain as a part of their obligation to stabilize patients with emergency conditions.

The Federation of State Medical Boards is also revisiting its Model Guidelines. This time, the Federation wants to make clear that serious neglect of pain may result in disciplinary action against physicians.

What Next?
The effort to change public policy toward improving the treatment of patients in pain cannot declare victory. The challenges for public policy in health care generally, and in pain management in particular, are cyclical. New research and emerging practices in the use of opioids for the treatment of chronic non-cancer pain changed the fundamental assumptions on which the disciplinary activity of the medical boards had been based. New learning in regard to pain treatment is bound to create serious gaps again.

Sentinel events on the national scene can significantly shift the center of emphasis in policymaking as well. The hope of the Mayday Project was that public policy could be shifted to take as a priority the well-being of patients in pain who suffer needlessly and who were neglected, in part, because of the single-minded public policy focus on the "drug war" and its impact on physician practices. The Model Pain Relief Act and the Model Guidelines were adopted against the backdrop of a movement to legalize assisted suicide that provided a sense of public urgency for improving the treatment of pain. More recently, however, the experience with OxyContin, with the DEA's actions against physicians prescribing controlled substances, and maybe with Rush Limbaugh, threaten to shift the balance away from pain relief and toward severe restrictions on the use of particular medications that are effective in the treatment of pain.

We are in a different position today than we were nearly ten years ago. Because of the work done by those at Saint Louis University School of Law and Mayday Scholars around the country, there is a strong body of research on the effect of legal standards on the treatment of patients in pain against which public policy now has to be measured. Scholarship has intrinsic value, of course, but when good scholarship can stimulate change for the better in an area as fundamental to human dignity as health care and the relief of suffering, there is a special satisfaction.

Jonathan FleeceWhen Jonathan Fleece, '97, decided to come to the School of Law because of its nationally recognized Health Law Program, he had no idea he would one day conduct research that resulted in legislation in several states and in the adoption of model guidelines for state medical disciplinary boards by the Federation of State Medical Boards.

He did know one thing, though - he wanted to find a way to help patients who suffered from intractable pain and couldn't get relief because doctors feared over-prescribing medication. So, with the guidance of Professor Sandy Johnson, who conducted a national effort to analyze and change legal barriers to pain relief housed at the American Society of Law, Medicine & Ethics and funded by the Mayday Fund, that's just what he helped to do.

"I had the good fortune of working on a project that focused on the undertreatment of pain, which was, and still is, a fact for many patients," said Fleece. "We've all lost family and friends to horrible illnesses like cancer and we all know people who suffer from intractable pain such as arthritis and other orthopedic conditions. So to know that, as a result of these statutes, physicians now have more freedom to treat patients with problems that necessitate pain medication is extremely rewarding. Seeing how many states now offer intractable pain statutes is a wonderful demonstration to me that just a few people can make significant contributions to a societal problem such as this."

The project Fleece speaks of is the Model Pain Relief Act he helped create, alongside fellow classmate Jackie Barrow, '98. The Act differed from legislation and regulations that existed at the time and it soon became quite influential. Even now, Fleece is amazed and incredibly pleased to see that less than a decade after he helped draft the Act, nearly four times as many states now have statutes providing legislative standards or a legislative mandate that the state medical board develop written guidelines for its monitoring of physician prescribing practices so that it would be clearly understood that inappropriate disciplinary actions would not be taken.

The import of his research was apparent to him as a student, and it was outlined in the article, "A New Prescription for Pain," he authored for the Journal of Health Law in 1997. And it's even more apparent to him now, as an attorney who has specialized primarily in health care law for the past seven years. He currently heads up a boutique health care law practice in the Tampa Bay area, where he almost exclusively represents physician practices, medical groups and ancillary health care providers.

"In my representation of physicians, we do come across situations where physicians ask me about patients who have concerns about substance abuse as a result of pain medication," said Fleece. "Florida has a form of the intractable pain statutes and the background knowledge I learned from the Model Pain Relief Act helped me with my clients regarding these issues."

Today he represents several pain management practices and appreciates the opportunity he has to "get into the trenches and see how these issues play out with physicians." What these intractable pain statutes have allowed physicians to do, he says, is to act in good faith and if they follow the protocol, they have some protection.

 

 

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