Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation

3. Ascending the Hierarchy of Regulatory Needs

3 Ascending the Hierarchy of Regulatory Needs Case 3A The Terminally Ill Patient Who Seeks Supplements A terminally ill patient seeks access to nutritional supplements that claim to reverse his disease. Because the label on these supplements has made an unapproved “disease claim”—linking the supplement to cure of a specific disease—the federal FDA has declared the supplements to be “new drugs” that cannot be distributed in interstate commerce without FDA approval. Pending resolution of the disease claim, the FDA has neither made any arrangements for expedited approval of access to the supplements nor authorized any regulatory exception allowing the patient access to the supplements . The FDA further has ordered the manufacturer to stop marketing the product and has required distributors to remove the product from the market. The patient claims that he has a constitutional right of freedom of access to the medication of his choice and, further, that the FDA is acting unethically in depriving him of such choice. The patient further argues that as his condition is terminal, the FDA is overstepping its role as a guardian of public health and has no right to interfere in his medical affairs. Case 3B The “Incompetent” Patient Who Subtly Evidences His Wishes An elderly patient on life support has been declared legally incompetent. The family is debating whether and when to disconnect the patient’s life support systems. The patient’s 81 sister whispers in the patient’s ears that “it is okay” for him to “let go and move on into the Light.” She then asks if this is what he wants. The patient’s pinkie visibly lifts an eighth of an inch. She asks again and receives the same signal. The sister asks that this tiny ideomotoric signal be accepted as “clear and convincing” evidence of the patient’s wishes, when there is no other evidence from prior written authorizations or verbal conversations. The sister then enters meditation in order to connect with the “spirit and life-force” of her brother and ascertain his wishes. She sees him clearly in meditation and reports receiving instruction from him that life support should be disconnected and that his body should remain in the hospital bed for three days following the disconnect, during which time she is to recite to him instructions from the Tibetan Book of the Dead, as he will be traveling through different realms en route to higher consciousness.1 She also states that if his body is prematurely moved, his consciousness will experience a great disturbance , which could ultimately result in less than satisfactory rebirth.2 She produces personal letters confirming that although her brother did not express clear preferences regarding his body and burial, he was profoundly influenced by Tibetan Buddhist teachings. The hospital ethics committee does not accept the ideomotoric signals or the information from her meditation as evidence regarding her brother’s wishes. The committee concludes that it is unethical to disconnect the life support and, further, that hospital policy is to have an undertaker remove a body within three hours after death is ascertained . Case 3C The Professor Who Receives Dictation from “Jesus” A medical school professor goes home one night and begins hearing a disembodied voice tell her to write notes for a new course. The physician by birth and childhood education is Jewish but professes to be an atheist. She consults her physician and is told that she has been hyperventilating as a result of stress from work and that the imbalance of oxygen and carbon dioxide could be resulting in hallucinations. She also is told that she is experiencing a mild mood disorder and that as her sleeping habits are irregular, her sense of real82 • Future Medicine ity has become more precarious. Her physician prescribes regular exercise , relaxation, a temporary muscle relaxant, and sleep medication. When the voice persists despite her best efforts to follow the therapeutic recommendations, the professor consults her psychiatrist. The psychiatrist prescribes one antidepressant and a second medication to control hallucinations. Yet the voice persists. Different kinds of medication are prescribed, to no avail. The professor consults her best friend, an intuitive healer, who advises her to discontinue the medications and pay attention to the voice. The voice continues to visit and insists that she take notes for a course to be entitled “A Course on Miracles.” The professor listens, asks the voice to identify itself, and is told the narrator is...