Coding professionalism: Ethics and consent

Medicine has a limited ability to cure. Hippocrates, focussed on the health of the patient in front of him, admonished his peers not to experiment or resort to heroic medicine (Lloyd, 1978). A declaratory statement by Hippocrates remains foundational to codes of medical practice: that is, that the duty of the physician lay in treating the patient by helping and doing no harm (Katz, 1996). While experimentation was acceptable to Hippocrates, experimental practice was to be focussed on curing or ameliorating the condition of the particular patient. There was no suggestion that a patient should be called on to sacrifice their body or health for the sake of others. Modern professional ethics, distinguished by Percival from the narrower medical ethics, were conceived in response to the outrage when the Manchester Infirmary refused entry to patients in the midst of an epidemic in 1792 because its staff members were in dispute (Baker & Emanuel, 2000).22 John Gregory and Thomas Percival were physician-ethicists who, in the 18th century, envisaged medicine as a profession vested with the moral duty of caring for the sick, a caring invested in the profession as a whole rather than in its individual practitioners. As the fiduciaries of their patients (McCullough, 1998), medical professionals were required to be competent and willing to challenge their own beliefs; to serve their patients,23 setting aside self-interest with

Welfare in 1979, it iterated the need for respect for persons, beneficence which maximised research benefits while minimising harm to people and ensuring non-exploitative and reasonable procedures.

22_{A colour etching entitled Doctors Differ and their Patients Die recorded this event (Baker &}

Emanuel, 2000, p. S15).

responsibility to peers24 taking a very secondary place; and, medicine was to be practiced as a public trust (McCullough, 2004). The American Medical Association (AMA) adapted aspects of this code in 1847 (Baker & Emanuel; Rothman, 1991).

The legal delineation of “informed consent” appeared in 1957 in an amicus curiae25

brief filed by the American College of Surgeons in Salgo v Leland Stanford University. The law drew on exemplary cases to contribute to the development of common law practices around consent in the US (Faden, Beauchamp & King, 1986). The history of informed consent refers to medical experimentation in Nazi Germany, a range of deceptive and harmful experiments, legal cases questioning interventions, the history of paternalism in medicine and the growing emphasis on the enactment of autonomy. While there is a history of academic attention to obtaining consent from patients within medical practice, the clinic and the laboratory, the reasonable achievement of informed consent has been affected by the narrow contexts of its practice. Although the citizen/patient should not experience unwanted contact (Faden, Beauchamp & King), the practice of consent relied on a set of physician behaviours in which material risks and benefits would be disclosed. Patient consent has tended to be limited because physicians determined the extent of disclosure (Katz, 1984). The relative value of patient autonomy has been restricted by culturally supported medical paternalism in a range of epithets such as “the doctor knows best.”

In the 20th and early 21st centuries, attempts to delimit medical practice by producing codes and standards of care and responsibility both from within and outside of medicine have proliferated. The Nuremberg Code is often discussed as the first document to set out explicit rules around clinical practice, human experimentation and the gathering of consent to participate (Vollmann & Winau, 1996). But a Prussian directive in 1900 had expressly prohibited non-therapeutic research without unequivocal consent with a second set of guidelines published in 1931. In the 1931 version of regulations on new therapies and experimentation, the Reich Health Council demanded that clear, unambiguous consent be obtained for all therapeutic and non-therapeutic research in human subjects. Both sets of regulations owed more to “critical public discussion and political debate” (Vollmann & Winau, p.1447) than to concerns about patient rights or safety expressed by medical professionals. The Nuremberg Code was “buried soon

after its birth" by American doctors who were considered to be deserving of “deference and encouragement, not oversight and outside management" (Hornblum, 1999, p.235). The Declaration of Geneva, the Helsinki Declaration, and the Belmont Report have provided an international backdrop to the practice of medicine as a science in the second half of the 20th century. As with the Nuremberg Code, these codes and practices were considered both unnecessary and too restrictive in relation in progressing medical science.26

Bioethicists have suggested that there was a paucity of standards surrounding human experimentation until this was rectified in the mid-1960s (Martensen, 2001). An alternative account is at least as viable. In the presence of considerable standards for ethical practice, if physician/experimenters then chose to behave poorly, this was due, not to the lack of ethical standards but to the personal decisions of physician experimenters to disregard those standards, in the knowledge that they would evade sanctions. The privacy and professional privilege operating in experimental arenas and clinical practice have allowed the obligations imposed by an international regulatory environment to be disregarded. In New Zealand, for instance, these regulations did not avert significant harm to women as demonstrated by experiments with carcinoma in situ, beginning in 1955 at National Women’s Hospital in Auckland (Anonymous [TV3 News], 2008; Bunkle & Coney, 1987; Cartwright, 1988; Coney, 1988; Jones & Fitzgerald, 2004; Phibbs, 2000).

Rather than doctors needing to prove themselves worthy of trust, patients have long been required to trust their doctors (Katz, 1996).27 _{Persuaded by their trust in medical}

professionals and belief in medical science, patients may make personal sacrifices in the name of scientific progress. Yet medical progress appears often to be valued over the safety of patients. This was demonstrated, rather ironically, on the fiftieth anniversary of the doctor’s trial at Nuremberg. Katz (para. 7) recalled one “distinguished” surgeon as saying: “[Conducting] controlled studies may well sacrifice a generation of women, but scientifically they have merit.” It is the duty of the practitioner to have a “[…] responsible, non-experimental, definitive dealing with the subject himself [and that] not even the noblest purpose abrogates the obligations this involves” (Jonas, 1969, p.219).

26 _{In 2008, the FDA decided that research studies submitted to it for review would not need to meet} the standards set by the Declaration of Helsinki: “They must only follow the industry-sponsored Guidelines for Good Clinical Practice outlined by the International Conference on Harmonisation (Annas, 2009, p.2050).

The bedrock principle of medical ethics is the promotion of the wellbeing of the individual patient.

A major obstacle to the achievement of best interests of patients lies at the interface of medical science with agendas of trade. While it may be argued that the best interests of patients lie in progressing medical science, the complex relationships of medicine with commerce complicate this relationship. The primacy of respect for persons, as subjects and patients, has been breached in the interests of advancing scientific medical knowledge (Katz, 1996) and in the service of a variety of political, social and personal agendas. When Kligman entered Holmesburg prison for the first time, he did so as a physician to attend to prisoners who were suffering from athlete’s foot (Hornblum, 1999). As he walked through the gates of the prison, he recalled this experience: “All I saw before me were acres of skin. It was like a farmer seeing a fertile field for the first time” (Hornblum, p.37). This was the beginning of over twenty years of experimentation in this Pennsylvania prison using a vulnerable population.

Practices in the clinic have been co-opted in the service of medical science, individual cases enumerated and eviscerated for their clinical material, ‘interesting’ cases in the service of knowledge, politics or reputation (Harrington, 2002; Rothman, 1993/2003). While some patients have been encouraged to make sacrifices in the service of scientific knowledge and the ‘interests of mankind,’ others have been coopted without their knowledge or consent. Notwithstanding codes of ethics nor the experiments which occasioned Nuremberg, the search for warm bodies (Shah, 2006; 2006a) has continued in Western countries: The Tuskagee syphilis study (Beecher, 1966; Bosk, 1999; Hornblum, 1999; 2007; Katz, 1996; Ryan et al, 1979; Sharav, 2001; Shah); the intradermal injections of live human cancer cells into 22 chronically ill, debilitated non-cancer patients in 1963 at the Jewish Chronic Disease Hospital (Beecher; Lerner, 2004; Standler, 1997); between 1963 and 1966, healthy retarded child residents of Willowbrook were intentionally inoculated, orally and by injection, with hepatitis and monitored to gauge the effects of gamma globulin in combating it (Beecher; Bosk; Sharav); the failure to treat carcinoma in situ in the National Women’s Hospital inquiry (Cartwright, 1988; Coney, 1988); the 1996 medical experiment conducted by Pfizer researchers in Kano, Nigeria, during a major meningitis epidemic,

in which physicians followed the research protocol rather than vary treatment to treat and prevent death (Annas, 2009).28

Kligman was quoted as saying, “I damned near killed people [before] I could see a real benefit […]. Everyone of them got sick” (Hornblum, 1999, p.214). When scientific falsification is the paradigm, mishaps and trials may be accepted as reasonable in the development of skills, knowledge, cures and trade. But I problematise benefit when it accrues mainly to large corporations, academic institutions and a variety of other individuals.