” EXPOSING THE DEA’S PAIN FRAUD SCAM”
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BRAHM FISHER ESQ., JOSEPH WEBSTER MD., ESTER HYATT PHD., BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
Johnson, Sandra H., JD, LLM
Legal and Ethical Perspectives on Pain Management
As Brennan et al. emphasize, the relief of pain is a core ethical duty in medicine. Unrelieved pain blocks the enjoyment of all other human goods and values. In the words of an oncology nurse who herself suffered from chronic pain: “This malady has been the most frightening, the most humiliating, and the most difficult ordeal of my life …. I became withdrawn, completely disabled by my terrible, relentless pain.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.” And, from a man with terminal cancer: “Pain is my biggest fear … it puts me in a darkness … you can’t find peace in that darkness of pain … Pain blinds you to … all that’s positive.” An individual with sickle cell describes emergency room visits: “They wanted to know why the medication was not working? Why are you still in pain? If you are crying, why are you crying; if you are not crying, how can you be in pain? … You are not only experiencing your pain … you are experiencing other peoples’ opinions and feelings; that makes it worse.” (4).
If we could come to understand that pain is not merely a cloak that a patient carries and that we can simply push aside, but that it is instead an attack on the human being’s core, we might see some progress. As in most medical matters, it is best if ethics takes the lead and law follows.
Trends in the Law
There have been some considerable improvements in the state of the law. Brennan et al. describes many of the developments in legal standards that affect the practice of pain management. The adoption of guidelines for state medical boards, for example, is very significant and considerably improved the environment for doctors treating pain patients (5). These guidelines specifically recognize that doctors have a duty to relieve pain and that medical boards must be as vigilant for cases of neglect in this regard as they have been in monitoring prescriptions of controlled substances. Moreover, at least half of the states have enacted legislation that protects doctors from disciplinary action and criminal prosecution (on the state level) if their treatment of patients meets general practice standards.
This is not to say that there are not still problems with the medical boards in particular states, but a great deal of progress has been made.
In addition, although one may believe that increasing the risk of liability for doctors can never be positive, the Bergman case, discussed in their article as well as the very similar Tomlinson case (8), are landmark legal cases. They establish that pain, standing alone and without another physical injury, can be recognized as an injury at law. They demonstrate how patients who suffer in the most egregious cases can seek a remedy in the courts—raw comfort though that may be. When the risk of legal penalty arises only for health care professionals who aggressively treat patients for pain, and not for health care providers who neglect their patients, the scales are out of balance and they could encourage substandard care.
Unfortunately, the law has not moved all in one direction. In fact, after some promising developments in 2001 and early 2003, the Drug Enforcement Administration (DEA) took steps backward by withdrawing the consensus document described by Brennan et al. and issuing policy statements that went in the opposite direction. Even the National Association of Attorneys General expressed concern that “state and federal policies are diverging with respect to the relative emphasis on ensuring the availability of prescription pain mediations to those who need them.” The prosecution and conviction of a Virginia physician for violation of the Controlled Substances Act, and other similar prosecutions, certainly affects doctors’ perceptions of legal risks, even though that conviction was later reversed by a federal appeals court. Although the number of doctors subject to DEA investigation is quite small, the consequences of such an action are quite severe. The DEA has since issued further statements on its policy, leaving its 2003 statement largely intact. On the same day, however, the DEA proposed new regulations that would allow doctors to write multiple sequential prescriptions for controlled substances for single patients (12).
The Practice Context Matters
It is customary to place pain into one of several broad categories; i.e., cancer pain, chronic nonmalignant pain, or acute pain. From the perspective of public policy and law, however, other categories are more useful. The legal environment for specific practice settings varies considerably, and the challenges faced by health care providers are also quite distinctive. Strategies to improve care cannot be “one size fits all.”
For example, treating pain in nursing homes, an area where neglect of pain is particularly prevalent, operates in a legal environment that has created a culture that resists extensive reliance on pharmaceuticals, especially those that may have an impact on alertness. In addition, nursing home patients can present particular challenges in pain management because of the incidence of dementia or other forms of mental confusion. Physicians in that institutional context, however, should feel free of concerns about diversion or addiction. Likewise, physicians treating patients who have cancer or terminal illness, in whatever practice setting and including office-based practice, face essentially no legal risk of the medical board or DEA actions for treating patients for pain. In contrast, concerns about diversion are extreme among physicians practicing in the emergency department, perhaps because doctors and patients are strangers to one another, even though emergency departments are not significant sources of diverted drugs. Emergency departments are not a prime target for investigation and prosecution. It is not the legal risk that explains the hypervigilance in emergency medicine.
In fact, most concerns about legal risks that might lead physicians to allow patients to suffer arise in the office-based practices that treat patients in chronic pain. The fear of DEA action, in particular, may lead doctors to avoid patients with chronic pain (although there is more to that avoidance than concerns about the DEA) and may steer those who do treat chronic pain patients with controlled substances to undertreat their pain. However, the practice management techniques described in the medical board guidelines will help to reduce those risks considerably.
We have persuasive evidence, as discussed in the article by Brennan et al. that neglect of pain persists in all practice settings. Although treatment for pain can be quite complex, neglect occurs even when that is not the case. It is not the law that explains that phenomenon in most practice settings, although the legal risk may be having an adverse impact in the office-based chronic pain practice. There surely is room for further development of legal standards and practices that are more conducive to improvements in pain management. As Brennan et al. argue so forcefully, it will take movement on many fronts to improve both cares for patients in pain and the environment for those who treat them.
Senator Hatch on DEA and Opioid Crisis and Abuse (6)(7)(8)
Improvement must begin, again, with professional ethics. The literature on obstacles preventing access to effective pain relief tends to treat these as matters of social or institutional fact. Instead, each of the barriers is essentially a question of ethics. Inadequate skills may be a result of inadequate training in medical or nursing school, but failing to learn while in practice breaches the professional’s ethical duty to maintain their competencies and continue to learn. Similarly, many of the common “red flags” used to screen out “drug seekers” are ineffective and inaccurate, and unethical, as they cause injustice in excluding entire groups of people solely for irrelevant characteristics.
Perhaps the greatest hope is to expand our view of the treatment of pain beyond a question of medical practice and toward a view of pain as a public health crisis. The shift is certainly justified on the basis of the staggering data on the financial costs of untreated pain. A public health approach may shift the focus to systems that will improve outcomes rather than on blaming doctors and other health care professionals. Personal and professional accountability for failing to treat patients competently and compassionately is critical, but so is creating environments that make effective care for patients in pain the norm.
THE CONGRESSIONAL COMMITTEES ON GOVERNMENT OPERATIONS, CONGRESSIONAL COMMITTEE ON THE JUDICIARY, THE CONGRESSIONAL COMMITTEE ON HOMELAND SECURITY, CONGRESSIONAL BLACK CAUCUS MUST BEGIN INVESTIGATIONS OF THE CORRUPTION WITHIN THE THE UNITED STATES DEPARTMENT OF DRUG ENFORCEMENT (DEA) IMMEDIATELY
AMERICA IS BETTER THAN THIS!!!
FOR NOW YOU ARE WITHIN THE NORMS
1. Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg 2007;105:205–21.
2. Snyder CA. An open letter to physicians who have patients with chronic nonmalignant pain. J Law Med Ethics 1994;22:204–5.
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3. Coyle N. Opioids, cancer pain, quality of life and quality of death: patient narratives and a clinician’s comments. In Meldrum ML, ed. Opioids and pain relief: a historical perspective. Seattle: IASP Press, 2003.
4. Johnson, Sandra H., JD, LLMAuthor Information, from the Tenet Endowed Chair in Health Law and Ethics, Center for Health Law Studies, Center for Health Care Ethics, Saint Louis University, St. Louis, Missouri. Accepted for publication March 29, 2007.
5. Address correspondence to Sandra H. Johnson, JD, LLM, Tenet Endowed Chair in Health Law and Ethics, Center for Health Law Studies, Center for Health Care Ethics, Saint Louis University, 3700 Lindell Boulevard, St. Louis, MO 63108. Address e-mail to email@example.com. Anesthesia & Analgesia: July 2007 – Volume 105 – Issue 1 – p 5-7 doi: 10.1213/01.ane.0000268148.38688.e7