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Home / Healthcare & Medicine / Medical Technology / Good Pharmacy Practice: Pharmaceutical Services / Historical events part II

Historical events part II

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14.4
1948, the Declaration of Geneva actually it’s a modern form of Hippocratic Oath. It was revised in 1948, 1968, and 1983.
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It says the physicians or practitioners is to make the health of my patient my first consideration. And, they are to consecrate my life to the service of humanity. And, I’m to respect my patients’ secrets even after death. And, to prevent consideration of religion, nationality, race, partly politics or social standing intervening between my duty and my patient. And, the physician’s duty is to maintain utmost respect for human life. And not to use medical knowledge contrary to the laws of humality. 1964, Declaration of Helsinki,
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this is probably the most famous and the most sophisticated recommendation guiding physicians in biomedical research involving human subjects. And, it has been gone through nine revisions. Start from 1975 and the newest updated revision is done in 2013. In 1966, a physician named Breecher, he accused an ethical research. He wrote an article name titled “Ethics and Clinical Research” published in JAMA in 1966. Breecher focused on human experiments in which patients were used not for their benefits. And researchers sometimes withheld known treatment. In the case Breecher considered most egregious, for example, penicillin was withheld from 109 soldiers with streptococcal infections; acute rheumatic fever developed in two and acute nephritis in one.
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He also accused in some cases, patients experienced harm or risk of harm without benefit. In others, researchers had not obtained consent.
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And these examples were not from a lunatic fringe. They are all from very famous hospital or institution. Four came from Harvard Medical School, three from the NIH Clinical Center and the rest from other prominent institutions. Tuskegee Syphilis Study is another scandal. It was exposed in 1972.
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The study was started in 1932, the Publish Health Service,
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working with Tuskegee Institute, began to study to record the natural history of syphilis in hopes of justifying treatment program for blacks. These subjects did not receive the proper treatment needed for cure their illness. Although originally project they projected to last like six months, and the study actually finally they have gone over 40 years. Even when penicillin became the drug of choice for syphilis in 1947, the researchers did not offer the medication to these subjects. In July 1972, an Associated Press story about the Tuskegee Study scandal caused a public outcry that led the Assistant Secretary for Health and Scientific Affairs to appoint an Ad Hoc Advisory Panel to review this study.
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On May 16th, 1997 President Clinton apologizes on behalf of the Nation to this scandal. 1981 is the Declaration of Lisbon, and this is a document concerned with the rights of patients. So, patients’ right, The patients could choose a doctor freely. And patient need to be cared for by a doctor whose clinical and ethical judgement are free from outside interference. And patient is to accept or refuse treatment after receiving adequate information. The patients could have his or her confidence respected. And also, patient could have the right to die in dignity. Also, they have right to receive or decline spiritual and moral comfort including the help of a minister of an appropriate religion. So, the four basic principles of health care ethics.
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There are number one, the principle of respect for autonomy. Number two, the principle of nonmaleficence. The third, the principle of beneficence. And the principle of justice. And this is recorded in the book called the name of “The Principles of Biomedical Ethics”. The authors are Beauchamp and Childress in 1979. The four principles bioethics become the major principle that when the practitioners need to consider the ethical problem, we need to consider each one and usually every ethical problem probably contain one, more than two or three principles of the four principles. They are conflict to each other. In terms of respect for autonomy, there are several issues could be relevant. The first one is informed consent.
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Because we need to respect the autonomy, so we need to have an informed consent to the patient. So, the patient need to know the pros and cons, the strength and the weakness, and the harm and benefit if they receive the research or the treatment. So, as long as they understand of these, they could choose whether they want to go on the research or receive the treatment or not. And also, they could reject, refuse to stop the treatment by the way without any extra explanation. In terms of autonomy, if a person does not have his or her own concisions, then we need to discuss the capacity or the competency for decision-making.
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The capacity for decision-making is the position of a person that are not the patient him or herself, and who is the correct or right position to make decision when the patient loss of consciousness or cannot make any decisions. So, the capacity usually under the law, there is a regulation how close a relative could make the decision for a patient himself of herself. Competency referred to the ability to make decision. A person under 7 years old or under 18 years old may not have individual, independent decision-making ability, so, at this time the parents could be the person make decision for the persons under 18 years old.
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It could be somebody older than 18 years old, but he or she has some competent intellectual inability, and then we need to find someone else to make the decision for these person. Advanced directives mean a person before he become unconscious or become unable to make decision, he could make a document, he could claim the person which one could make the decision for him or herself in advanced. So, this is advanced directives. Surrogate decision-making referred to someone could make decision for the person him or herself and this also referred to the capacity and competency too.

Chiang continues to illustrate more historical events that occurred from 1964 to 1981. He also briefly mentions the 4 basic principles of healthcare ethics.

Key points

The Declaration of Geneva is a modern form of Hippocratic Oath. It was revised in 1948, 1968, and 1983.

The 1964 Declaration of Helsinki is probably the most sophisticated guide on research involving human subjects. It has gone through nine revisions, with the latest version being completed in 2013.

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This content is taken from
Taipei Medical University online course,

Good Pharmacy Practice: Pharmaceutical Services

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In 1966, a physician named wrote an article titled “Ethics and Clinical Research”. He brought attention to many unethical research including some conducted by prestigious organizations.

Tuskegee Syphilis Study is major scandal exposed in 1972. The case invoked national uproar in the US.

The 1981 Declaration of Lisbon, focus on the rights of patients. Which changed the traditional belief that doctors should decide everything for the patients.

4 basic principles of health care ethics:

  • Respect for autonomy

  • Nonmaleficence

  • Beneficence

  • Justice

Issues related to respect for autonomy:

  • Informing the patient of the research or treatment they are about undertake.

  • If the patient has capacity and competency for decision-making.

  • Advanced directives should a person become unable to make decision.

  • Surrogate decision-making.

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Have you learnt about any of the above historical events?

Which one intrigued you the most?

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This content is taken from Taipei Medical University online course
Good Pharmacy Practice: Pharmaceutical Services
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