The vow to "guard my life, my art, and my science" acknowledges that one must be self-reflective to live a moral personal and professional life as a physician. The Oath does not presume that a physician has moral integrity. Vigilance guaranteed by an oath is required. The threats a physician must guard against are not specified but presumably include temptations or coercion to act in ways that do not benefit the ill, or that allow injustice, harm medical education, or breach promises to one's teachers.15 The fact that the Oath requires a physician to swear to be vigilant to guard his own integrity highlights the fact that a physician who is not morally vigilant risks practicing medicine in a way that is not holy.
The physician's moral vigilance must look to "my life and techne [art and science]." By these words the Oath emphasized that the physician's personal and professional (techne) lives must be morally coherent, though it does not assert that the same moral obligations apply to each of them.16 The Oath's closing also refers to the moral unity of the personal and professional life, "may it be granted to me to enjoy the benefits both of life and of techne" [art and science], (see Chapter 13). In that later passage, the Oath builds from this passage asserting the moral importance of their unity to add the Greek belief that a good life is the most secure foundation for a happy life. Perhaps more important for professional ethics, a good life is one that achieves excellence in its purpose, an excellence that must include the exercise of virtues that are instrumental to one's life work.17 Thus, in its separate uses of "life and techne," the Oath commits the physician's entire moral life to that which is required to be a good physician.
This comprehensive vow is intensely personalized in its unique three-fold use of the first person: "In a pure and holy way, I will guard my life and my techne [art and science]." As von Staden notes, the triple proclaiming of the first person, to an even greater degree than the other elements of the Oath, seems to suggest that this passage was a self-transforming ritual of purification itself.18 The placement of this passage at the very threshold to the patient's house emphasizes the ideal of medicine as a moral profession.
CASE 8.1 Isaac is an older friend, a dignified, well-read gentleman. One day he said to me, "I want your advice on how to write a letter to my doctor. She prescribed a medicine for osteoarthritis in my hips. Soon after starting it, my legs began to swell. I told my doctor about this, and she gave me some pills to remove the excess fluid. The drug damaged my kidneys and now I may need to go on an artificial kidney machine. She should have known that a person of my age could get kidney failure from that drug. I trusted her judgment that this medication was right for me. I feel that she let me down."
This chapter has focused on what the Oath said about the importance of a physician's integrity to medical work. Professional integrity is crucial both to fostering a trusting physician-patient relationship as well as to maintaining trust between society and the institutions and activities of medicine. Does this passage from the Oath still speak to the medical ethics of integrity? There are several ways to consider how this passage might address the issues in Isaac's treatment.
One could focus, as Isaac does, on the integrity of his physician. She had prescribed a non-steroidal anti-inflammatory drug (NSAID). Such drugs are often recommended for treating arthritis pain. Isaac felt that his physician had erred either in selecting the medication or in failing to monitor him for a known and serious side effect. Isaac correctly believes that a physician who is negligent in keeping informed about how to optimally use the tools of medicine to benefit and not harm a patient lacks a kind of integrity with regard to the physician's pledge to "benefit of the ill." There is no evidence, especially given the widespread use of these drugs for people like Isaac, to suggest that this physician's prescription of this drug was inattentive. If Isaac's physician's failed to detect his problem because she was seeing too many patients, this might indicate a lack of integrity in which Isaac's health was endangered by the physician's (or clinic's) desire for high revenues.19 Not every error or bad outcome necessarily signifies that a lack of professional integrity, however, (see Chapter 9).
The physicians who worked at the behest of pharmaceutical companies to develop these drugs also shaped the clinical decision that resulted in this drug's being prescribed to Isaac. To understand how their integrity might be related to Isaac's injury requires some history. Physicians and drug companies have long known that older people like Isaac need better arthritis medications, and in the 1960s, NSAIDs seemed a promising development. They neither had the addictive potential of narcotics nor caused bone degeneration like the corticosteroids. However, long before these drugs came to market, physician-scientists knew that NSAIDs caused kidney disease.20 Researchers soon discovered that older people were especially at risk of serious kidney disease. In 1974, the New England Journal warned that a new NSAID was "best not used" in the elderly.21 By 1982, 70 million prescriptions for NSAIDs were filled in the United States, and more than half of these were for the twelve percent of people over 65 years old.22 By 1984, independent researchers were urging "extreme caution" in using NSAIDs in high-risk groups, including people with common diseases of the elderly.23
Though these drugs were being marketed, sold, and prescribed to elderly persons, only two percent of the subjects in NSAID arthritis studies conducted between 1987 and 1990 were elderly. Corporate-sponsored researchers often failed to support their claims of the superior safety.24 By 1990, NSAIDs accounted for twenty-five percent of all drug side effects.25 The issue of integrity is raised by medical research that heralds benefits by studies designed to avoid assessing the serious risks to those who will probably use that drug and to whom that drug is marketed. Unfortunately, this problem with professional integrity is common in corporate-sponsored pharmaceutical research.
Drug companies provide more funding for medical research in the United States than the federal government.26 Some of this money is spent in corporate labs; some goes to university medical researchers. Some university researchers also receive speaking fees, consultancies, equipment, stocks, or stock options that fluctuate in value according to a company's profits. These forms of compensation can vary in worth from a few hundred dollars to more than a hundred thousand dollars per year.27 Three-fourths of the professors who accept such material consideration say that it is important to their work. Drug companies even hire advertising agencies to conduct pharmaceutical research.28 In short, researchers conduct a great deal of research while having significant financial stakes in the outcome of the research or in maintaining an ongoing pecuniary relationship with a pharmaceutical manufacturer. Such ties are morally problematic if they adversely affect the conduct of research or harm patients. Unfortunately, they do.
Corporate drug development has two aims: to make a profit and to promote health. These valid interests can conflict with each other, and such strains can extend to the conduct and reporting of biomedical research. Corporate-sponsored research tends to exaggerate the benefits of a specific drug, minimize its harms, understate costs, and promote the use of a newer treatment over a comparably effective and less expensive therapy.29 Biases are designed into the studies. In NSAID research, for example, the studies were done on younger persons who were at lower risk of side effects than those who would be the major users of the drugs. A new drug may be compared with an unfairly low dose of a competing drug. A drug may shine against a placebo when it is no better than an inexpensive conventional treatment. Test scores or lab values can create the appearance of benefit when a person's health is not changed. The data from this distorted research are then disseminated to shape clinical decisions, such as the decision to use the NSAID for Isaac. Physicians who accept remuneration from corporations are much more likely to defend a controversial drug than those who do not accept this kind of support.30
Corporate sponsors favorably "spin" and disseminate research findings. Corporate writers often write scientific papers that respected research physi cians review and then sign as the authors. Corporations have threatened to sever relationships with researchers who do not deliver favorable findings, and occasionally to sue researchers or medical journals if unfavorable, albeit accurate, data are published.31 Data files of corporate clinical studies are often closed, thereby preventing independent assessments of their findings. The research findings form a curriculum for professional education, including Doughnut Rounds, (see Chapter 4.)
Is it fair, however, to argue that this passage from the Oath can speak to the issue of the integrity of modern corporate-sponsored research? It would be hard to argue that ancient Greeks could have anticipated modern corporate drug research. Even so, do the Oath's words on integrity apply to the creation and dissemination of medical knowledge in ancient Greece? If so, they can speak to us today. As noted in Chapter 4, the ancient Greek idea of experiments did not involve clinical trials with multiple subjects. Instead, each patient was given the best therapy possible, and by these individual cases, the physician tried to discern how to improve the practice. The ancient treatises stress the physician's duty to accurately and fairly note observations upon which inferences and subsequent treatment recommendations were made. As the author of On Ancient Medicine wrote, "if anyone were able to light upon the truth by experiment . . . he would always be able to make the best pronouncements of all."32 The entire corpus of the practical casework of ancient Greek medicine is essentially the records of these experiments.
Modern physicians use different research methodologies but have essentially the same goal: to accurately collect and describe their experiments. They go to great lengths to acquire accurate data by randomly assigning research subjects to receive one drug or the other and not informing researchers which person has received which therapy until after the clinical outcomes have been collected. Falsely reporting procedures for randomizing patients, the treatments that were given, how the researchers were blinded, or the measurements of results are all acts that are censured as research fraud. Ironically, though numerous studies show that corporate sponsorship distorts the design and dissemination of research, reforms for this problem are largely stalled.33 Furthermore, even if regulatory reforms were implemented, compliance with the spirit of those reforms would squarely engage the integrity of physician-researchers. As Isaac's case shows, the integrity of the design of research and of the way that research findings are disseminated directly affects the patient's well-being.
1. Von Staden leaves "techne" in Greek. I have rendered it as "art and science." Chadwick renders techne as "art" (Hippocrates ). Jones translates it as "Science" (Hippocrates ). Techne refers to the purposeful and discerning application of the natural science of medicine. As a science, it includes universality, generalizability, teachability, precision, and concern with explanation (Nussbaum 95-121). As an art, it includes wisdom and insight. Techne is more than the unreflective practice of an acquired skill or tradition. It is unlike tuche, the luck or coincidence that lies behind a testimonial on behalf of the worth of a charlatan.
2. von Staden H. "In a Pure and Holy Way": Personal and professional conduct in the Hippocratic Oath. J Hist Med Allied Sci 1996;51:404-37.
3. There were medical cults, such as the group that probably wrote the medical treatise entitled Law, that use holy in a cultic sense: "Things that are holy are revealed only to men who are holy. The profane may not learn them until they have been initiated into the mysteries of science. (Law V)" See (Hippocrates 1923) note by Jones 273, 5. There is no evidence that this was a dominant view of Hippocratic-era physicians.
4. Childress and MacQuarrie 269.
6. Pearson 90-160.
7. Euripides. The Trojan Women 68-85.
8. Adkins 86-102. Parker extensively discusses this.
9. Temkin O. "An Historical Analysis of the Concept of Infection," in Boas et al., 123-47 at 125. Unfortunately Temkin did not develop the grounds for this remark.
11. Plato. Cratylus 405a-h.
12. I accept von Staden, who reads this as a pledge to act in an honorable way, though others read it as a promise to maintain a virtuous character (Pellegrino and Thomasma 120). Pellegrino is careful, though, to not reduce the Oath simply to a pledge to have virtue; he emphasizes that the Oath as a whole includes responsibilities and rules as well (Pellegrino 107, 115-6, 126-9).
13. Pellegrino 125-6. The concept of prudence is elaborated on in Pellegrino 130-49.
14. Nussbaum MC. Non-relative virtues: An Aristotelian approach. Midwest Studies in Philosophy 1998;13:32-53.
15. von Staden H. "Character and Competence I: Personal and Professional Conduct in Greek Medicine," in Flashar and Jouanna 157-210.
16. Pellegrino 107.
17. Maclntyre 146-164,204-226 esp. 219-21.
18. The personally transforming nature of the swearing the Oath is discussed more extensively in the Afterword.
20. Stewart JH.
21. Mills JA. Nonsteroidal anti-inflammatory drugs. N Engl J Med 1974;290: 780-4.
22. Rochon PA, Fortin PR, Dear KBG, et al. Reporting of age data in clinical trials of arthritis: Deficiencies and solutions. Arch Intern Med 1993;153:243-8.
23. Clive DM, Stolf JS. Renal syndromes associated with nonsteroidal anti-inflammatory drugs. N Engl J Med 1984;310:563-72.
24. Rochon PA, Fortin PR, Dear KBG, et al. vid supra.
25. Rochon PA, Gurwitz JH, Simms RW et al. A study of manufacturer-supported trials of nonsteroidal anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 1994;154:157-63.
26. Rettig RA. The industrialization of clinical research. Health Aff 2000; 19: 129-46.
27. Boyd EA, Bero LA. Assessing faculty financial relationships with industry: A case study. JAMA 2000;284:2209-14. Campbell EG, Seashore L, Blumenthal D. Looking a gift horse in the mouth: Corporate gifts supporting life sciences research. JAMA 1998;279:995-9.
28. Peterson M. Madison Avenue. Plays Growing Role in the Business of Drug Research. New York Times, 2002;(November 22): Al, C4.
29. Stelfox HT, Chua G, O'Rourke K, Detskv AS. Conflict of interest in the debate over calcium-channel antagonists. N Engl J Med 1998;338:101-6.
30. Bodenheimer T. Uneasy alliance: Clinical investigators and the pharmaceutical industry. New Engl J Med 2000;342:1539-44. Friedberg M, Saffran B, Stinson TJ, et al. Evaluation of conflict of interest in economic analyses of new drugs' use in oncology. JAMA 1999;282:1453-7. Rero LA, Rennie D. Influences on the quality of published drug studies. Int J Technol Assess Health Care 1996;12:209-37. Kjaergard LL, Bodil AN. Association between competing interests and authors' conclusions: Epidemiological study of randomized clinical trials published in the BMJ. BMJ 2002;325:249-53.
31. Nathan DG, Weatherall DJ. Academic freedom in clinical research. N Engl J Med 2002:347:1368-70.
32. Tradition in Medicine 20,24. Translation from Hippocrates 1950. Loeb title of same treatise is On Ancient Medicine.
33. Schulman KA, Seils DM, Timbie JW, et al. A national survey of provisions in clinical trial agreements between medical schools and industry sponsors. N Engl J Med 2002;347:1335-41. Some medical journals now require that researchers show that they are independent of corporate control before a paper will be accepted for publication. (Davidoff F, De Angelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. Ann Intern Med 2001;135:463-5.) Some propose that companies give funds for researching a particular drug to an independent group that would choose a research design and researchers to evaluate the drug.
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