On 2nd June 1948 seven men were hanged for crimes committed in World War Two. Although all held some form of military rank none had actually fired a gun in combat. Four of them were doctors. They, along with sixteen other defendants, had been on trial from 9th December 1946 to 20th August 1947 to answer for the horrors of Nazi human experimentation under the guise of Medicine. A common defense used in response for their crimes was that there was no agreed standard saying what they had done was wrong. After almost 140 days of proceedings, including the testimony of 85 witnesses and the submission of almost 1,500 documents, the judges disagreed.
The Nuremberg trials are rightfully held up as a landmark of medical ethics. Yet they are only one point on a timeline that stretches back to the very beginnings of Medicine. This musing is a brief journey through that timeline.
The Hippocratic Oath
Hippocrates
We start with Hippocrates (c. 460 BCE to c. 370 BCE) a Greek physician considered the Father of Medicine. The Hippocratic Oath is attributed to him, although it may have been written after his death. The oldest surviving copy dates to circa 275 CE. The original text provides an ethical code for the physician to base themselves on:
I swear by Apollo Physician, by Asclepius, by Hygieia, by Panacea, and by all the gods and goddesses, making them my witnesses, that I will carry out, according to my ability and judgment, this oath and this indenture. To hold my teacher in this art equal to my own parents; to make him partner in my livelihood; when he is in need of money to share mine with him; to consider his family as my own brothers, and to teach them this art, if they want to learn it, without fee or indenture; to impart precept, oral instruction, and all other instruction to my own sons, the sons of my teacher, and to indentured pupils who have taken the physician’s oath, but to nobody else. I will use treatment to help the sick according to my ability and judgment, but never with a view to injury and wrong-doing. Neither will I administer a poison to anybody when asked to do so, nor will I suggest such a course. Similarly I will not give to a woman a pessary to cause abortion. But I will keep pure and holy both my life and my art. I will not use the knife, not even, verily, on sufferers from stone, but I will give place to such as are craftsmen therein. Into whatsoever houses I enter, I will enter to help the sick, and I will abstain from all intentional wrong-doing and harm, especially from abusing the bodies of man or woman, bond or free. And whatsoever I shall see or hear in the course of my profession, as well as outside my profession in my intercourse with men, if it be what should not be published abroad, I will never divulge, holding such things to be holy secrets. Now if I carry out this oath, and break it not, may I gain for ever reputation among all men for my life and for my art; but if I break it and forswear myself, may the opposite befall me.
The oath has been used in update iterations as a pledge for doctors to make on graduation.
The Formula Comitis Archiatrorum is the earliest known text on medical ethics from the Christian era. It was written by Magnus Aurelius Cassiodorus (c. 484-90 to c. 577-90 CE), a statesman and writer serving in the administration of Theodoric the Great, the king of Ostrogoths. It laid out a code of conduct for physicians to align their lives and medical practice with.
Ethics of the Physician was penned by Ishāq bin Ali al-Rohawi, a 9th century Arab physician, and is the first medical ethics book in Arab medicine. It contains the first documented description of the peer review process where a physician’s notes were reviewed by their peers.
Primum non nocere and the beginnings of ‘medical ethics’
The phrase ‘primum non nocere’ (first do no harm) is often attributed to Hippocrates and the Hippocratic Oath. The exact author is unknown, however. One study looked at medical writings back to the Middle Ages and found the first mention in 1860 attributed to a physician Thomas Sydenham.
Thomas Percival
In 1794, Thomas Percival (1740-1804) created one of the first modern codes of medical ethics in a pamphlet which was expanded in 1803 into a book: Medical Ethics; or, a Code of Institutes and Precepts, Adapted to the Professional Conduct of Physicians and Surgeons. This was the first use of the phrase ‘medical ethics’. The book largely influenced the American Medical Association code, which was adopted in 1847. An Introduction to the Study of Experimental Medicine was written by French physiologist Claude Bernard (1813-1878) in 1865. Bernard’s aim in the Introduction was to demonstrate that medicine, in order to progress, must be founded on experimental physiology.
Nuremberg and Helsinki
After the failed defence of the defendants in the Doctors Trial The Nuremberg Code, written in 1947, is a ten part code guiding research ethics:
The voluntary consent of the human subject is absolutely essential.
The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment..
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
It’s not hard reading this code to see the inspiration from the trials behind the code, in particular empowering patients. The Nuremberg Code remains a keystone of medical research.
Another keystone is The Helsinki Declaration, a set of ethical principles for research on human subjects, developed by the World Medical Association in 1964. It’s not a law in itself but has been used to form the basis of laws in the signatory countries. The original draft contained five basic principles, a section on clinical research and a section on non-therapeutic research. It has been revised several times since, most recently in 2013 which contained thirty-seven principles. 1979 saw the publication of the first edition of Principles of Biomedical Ethics by philosophers Tom Beauchamp and James Childress. It is this book which gave us the four ethical principles often quoted by medical students:
Beneficence (promoting well being)
Non-malevolence (not doing harm - drawing back to primum non nocere)
Autonomy (the patient’s right to decide for themselves)
Justice (the community at large)
Scandals
Despite Nuremberg and Helsinki a number of scandals occurred throughout the 20th century reflecting inequalities and prejudices in society. In 1951, a young American black woman named Henrietta Lacks had a piece of her cancerous tumour extracted without her knowledge. The cells from Henrietta’s cervical tumour, known as HeLa cells, were the first human cell line to survive in-vitro and have since been immortalised for testing new medical treatments, most notably the Polio vaccine.
Henrietta Lacks
However, the case raised serious concerns surrounding the lack of informed consent and taking samples from living patients. In 1997, President Bill Clinton issued a formal apology for the Tuskegee Syphilis Study, which took place between 1932 and 1972 in the state of Alabama. This infamous government experiment allowed hundreds of African-American men to go untreated for their syphilis, so doctors could study the effects of the disease. This continued even after penicillin was discovered to be an effective cure. This was one of a number of unethical studies performed in the 20th century including the Guatemalan Syphilis Study and the Skid Row Cancer Study. When we talk about ethics we often think about Nazis and other deplorable regimes I think these studies remind us that even in the democratic West we are more than capable of committing horrible acts against vulnerable people.
Reproductive advances & rights and Alder Hey
The latter part of the 20th century saw a growth in women’s rights including their reproductive rights and the abilities of reproductive medicine. The Abortion Act was passed in the UK in 1967 after widespread evidence that unsafe illegal abortion can often result in maternal mortality/morbidity. The Act made abortion legal in all of Great Britain (but not Northern Ireland) up until a gestational period of 24 weeks. In 1973 the US Supreme Court voted in favour of Jane Roe in the case of Roe vs. Wade. The Court ruled 7-2 that access to safe abortion is a fundamental right. The arguments contained within this court case are still prominent topics of debate to this day.
Louise Joy Brown was born in Oldham, UK in 1978. She was the first baby to be born as a result of in-vitro fertilisation (IVF). The Report of the Committee of Inquiry into Human Fertilisation and Embryology, commonly called The Warnock Report was published in 1984 as a result of a UK governmental inquiry into the social impacts of infertility treatment and embryological research. The Human Fertilisation & Embryology Act 2008 updated and revised The Human Fertilisation and Embryology Act of 1990 in the UK, and implemented key provisions within IVF and human reproduction. These include the banning of sex selection for non-medical purposes and that all human embryos are subject to regulation.
The Human Tissue Act 2004 created the Human Tissue Authority to "regulate the removal, storage, use and disposal of human bodies, organs and tissue." In response to the Alder Hey organ scandal which involved the removal and retention of children’s organs without parental knowledge or consent.
The right to die
In February 1990, Terri Schiavo collapsed at home after suffering a cardiac arrest. The oxygen supply to her brain was cut off and, as a result, she entered a "persistive vegetative state" from which she would never wake. For the next 10 years, Terri's husband would fight various legal battles against her parents, and eventually the state of Florida, to enable her feeding tube to be removed. Her case was one of several sparking an enduring national debate over end-of-life care and the right to die. Dignitas was founded by in 1998 by Ludwig Minelli, a Swiss lawyer specialising in human rights law. Since its foundation Dignitas has helped over 2,100 people with severe physical illnesses, as well as the terminally ill, to end their own lives. In the UK the Assisted Dying Bill was blocked by the House of Lords in 2007. The bill would have only allowed those of sound mind and with less than six months to live to seek assisted death. Both euthanasia and assisted suicide remain illegal in the UK.
In 2016 Charlie Gard was born in the UK with an exceedingly rare and fatal inherited disease - infantile onset encephalomyopathy mitochondrial DNA depletion syndrome (MDDS). The ensuing legal battle between Charlie's parents and his doctors over withdrawing life-support provoked passionate debate throughout the world. It illustrated the power of social media to both facilitate and hamper debate around autonomy, end-of-life care, and parental rights with ugly scenes of mob violence threatened against the staff looking after Charlie. It also showed how complicated nuanced cases can be hijacked by various individuals and groups to spread their own agenda, such as the American right.
How we can show we respect research ethics
For anyone working in clinical research Good Clinical Practice is the international ethical, scientific and practical standard. Everyone involved in research must be trained or appropriately experienced to perform the specific tasks they are being asked to undertake. Compliance with GCP provides public assurance that the rights, safety and well being of research participants are protected and that research data are reliable. More information can be found on the National Institute for Health Research website who offer both introduction and refresher courses.
Looking at the timeline of medical ethics it’s tempting to think that we’ve never been more advanced or ethical and the whole movement is an evolution to enlightenment. To a certain extent that’s true, of course things are better than they were. But we can’t be complacent. The trend is that ethics often lag behind medical advances. As we become better at saving the lives of premature children, our population ages with more complex diseases and our resuscitation and intensive care improve there will undoubtedly continue to be more debates. As the case of Charlie Gard showed these can be very adversarial. Social media and fake news will no doubt continue to play a huge part of any scientific discussion, be it in medicine or climate change. All the more reason to stick to our principles and always aim to do no harm.
Thanks for reading
- Jamie