One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior.
The federal government's introduction in 1983 of DRG‐based reimbursement for Medicare patients shook the entire health care industry into the vigorous and dramatic cost containment efforts which today are reshaping health care in America.
Several prominent cases have recently highlighted tension between the interests of individuals and those of the broader population in gaining access to health care resources. The care of Helga Wanglie, an elderly woman whose family insisted on continuing life support long after she had lapsed into a persistent vegetative state (PVS), cost approximately $750,000, the majority of which was paid by a Medi-gap policy purchased from a health maintenance organization (HMO). Similarly, Baby K was an anencephalic infant whose mother, believing that all life is precious regardless of its quality, insisted that the hospital where her daughter was born provide mechanical ventilation, including intensive care, whenever respiratory distress threatened her life. Over the hospital's objections, courts ruled that aggressive care must be provided. Much of Baby K's care was covered by her mother's HMO policy. In the 1993 case of Fox v. HealthNet, a jury awarded $89 million to the family of a woman whose HMO had refused, as experimental, coverage for autologous bone marrow transplant in treating her advanced breast cancer.
The discussion about complementary and alternative medicine (CAM) is sometimes rather heated. “Quackery!” the cry goes. A large proportion “of unconventional practices entail theories that are patently unscientific.” “It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine — conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work.” “I submit that if these treatments cannot withstand the test of empirical research, … then we have wasted a lot of time and effort. The time has been wasted on all the people who have spent years learning falsehoods about acupuncture points and the principles of homeopathy. And the patients have wasted their time, money, and efforts receiving treatments that were not what they were represented to be or were harmful.”
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