Here we shall examine medical ethics in clinical practice and ethics in medical research.
This chapter will cover the following headings:
- Ethics Reflect Society
- Ethics in Medical Practice
- Advance Directives or Living Wills
- Animals in Research
- Humans in Research
- Research on Children
- Expert Witnesses
- Further Resources
- Site Index
If you wish to go directly to any section, click on the title in blue.
Ethics reflects morality and standards in society. This changes over time. New medical advances can produce new ethical conundrums. Advance directives or living wills are now enshrined in law. Consent is not a simple matter, nor are life and death decisions. The age of consent can also be a grey area. Both animals in research and humans in research will be discussed as well as the special issues of research in children.
For the Ancient Greeks, morality and what was expected of a person varied according to who they were. Ethics were different for men and women and for citizens or slaves. Socrates (470-399BC) was revolutionary in declaring that ethics were the same for us all, regardless of gender or social status.
Ethics Reflect Society
I had intended to make this section solely about ethics in medical research but it became clear that there is a great deal about ethics in practice that is also relevant to the reader who is interested in how medicine is practised and how decisions are made. Ethics is about morality. It often has a religious basis but whether it is from the Ancient Greeks, from Christianity or any of the other major religions of the world, there is much in common. Man has an innate sense of morality that in many ways transcends time and place.
The ancient Egyptian goddess Maat represented truth and natural justice.
These are essential features of civilisation.
However, there is much that has changed over the years and this is worthy of discussion. Today it is universally accepted that slavery is wrong, but this concept is only a couple of hundred years old.1William Wilberforce. At the time of the New Testament, slavery was accepted as a fact of life. Attitudes towards homosexuality have changed enormously, at least in civilised countries. In recent years, young people have wanted to tear down statues of the Victorian greats, allegedly because they were racist. If these young people had more insight, they would realise that before about 1960, most people were racist by modern standards. They lack the insight to ask how the Victorians would look at them today, if they could. They would find them godless, shallow, narcissistic with selfies and living their lives on Facebook, lacking respect, selfish and mentally frail. We now call them snowflakes.
Medical advances sometimes produce ethical conundrums that were not present before. Ethics is not fixed in time but needs to move with the time. As well as looking at ethics in practice, the law is also considered and this has changed much in recent years. A doctor must remain within the limits of the law.
Ethics in Medical Practice
The Hippocratic Oath is often seen as the first attempt to put medical practice on an ethical basis but this is unlikely. The Ancient Egyptians and probably other civilisations had something similar. The Hippocratic Oath lays down principles that may be summarised in the words, “always treat your patients with the care, dignity and respect that you would wish afforded to you”. It starts with the words, “I swear by Apollo the physician, and Asclepius, and Hygeia and Panacea and all the gods and goddesses as my witnesses” and includes pledges not to perform abortions or to “cut for the stone”. The latter would be bladder rather than kidney or gall stones. This is incompatible with modern practice and swearing by ancient gods is contrary to modern religions or secularism. However, some 98% of American and nearly 50% of British medical students swear some kind of oath, either on entry to medical school or at graduation.2Medical Oaths and Declarations An updated version was written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, Boston, Massachusetts and it is used in many medical schools today.
It enshrines the concept of patient confidentiality. This is not sacrosanct in law and a judge can force a doctor to reveal information given in professional confidence. Even the priest in the confession box is not above the law but, as with the doctor, a judge will insist on breaking that confidence only in the most extreme case. Only a lawyer has client confidentiality protected by law. The oath includes the sanctity of human life. It enshrines integrity and not taking advantage of one’s position. The phrase about not cutting for the stone can be summarised as “I shall not undertake procedures that are outside my knowledge, skill and ability. I shall instead refer to a colleague who is better equipped to perform that procedure.” Again, that is entirely applicable today.
As recently as the 1960s and 1970s, a doctor would not normally tell a patient that he had cancer. He may tell the family but not the patient. This resulted in some rather silly games of denial. In 1973 and 1974, I remember patients who were receiving radiotherapy telling me, “At least it’s radiotherapy and not radium therapy because radium therapy is for cancer”. They had managed to delude themselves into thinking that radiotherapy is some sort of physiotherapy and not for malignancy. In the 1980s, when doing on-call in general practice and seeing other doctors’ patients, there were many occasions when the family met me before I saw the patient to tell me, “He has cancer but he doesn’t know about it or it would crack him up”. Sometimes the patient would also confide to me, “I have cancer but they mustn’t know it or it would crack them up.” These silly games of denial prevent honest exchanges in the final days so that things remain unsaid that ought to have been said and closure is not achieved.
There are practical reasons why a person needs to know a bad prognosis. Perhaps they have a feud with friends or family and they need to settle it to die peacefully. Perhaps there are things they want to do and places they want to go whilst they are still fit enough. They need to make a will. About a third of people die intestate and even when they think it is obvious what they would wish, it is much easier for the executor of an estate with a will than without one. Nowadays, end of life issues such as where to die and pain relief may be discussed. I find this much healthier than the days of denial.
Doctors are much less paternalistic and authoritative than they used to be. They now encourage patients to take part in the decision making process and much of the 21st century reforms to the NHS have enshrined this. When I first tried it in the 1980s, patients would often reply, “You’re the doctor. You tell me.” They liked paternalism. Today it is often taken as a pejorative term but it comes from the Latin “pater” meaning father, and fathers love their children and care greatly about them.
Doctors and other healthcare professionals should not be ashamed of being caring and conscientious for their patients. They are not clients and if the relationship is of service provider and service user, we have reached a very sorry state.
With this reaction against paternalism comes the insidious introduction of the word “client” instead of “patient”. It is not a term that I have heard used by doctors although I suspect that it is on its way. It is used more by nurses, especially in mental health and other mental healthcare professionals. The relationship with a patient and a client are not the same. Despite the legal term of a “duty of care”, there is not the same ethos of caring for a client.3Patients or clients? Caring is a good attribute. More recently, I have heard patients referred to as “service users”. This is an even more absurd and impersonal term than clients. Some nursing courses prefer the term. This suggests that care and professionalism have hit rock bottom. The professional relationship between service users and service providers is at a lower level than between a customer and a shop assistant, or sales consultant as they now prefer to be called, or a supermarket employee, who now is known as a colleague. He is not my colleague. Fitters are called engineers and many menial jobs assume titles that are delusions of grandeur.
One of the dicta of medical practice is primum non nocere which means first do no harm. It was very important in days when medical interventions were of dubious value and it was easy to leave the patient in a worse condition than before. Indeed, many early treatments, including blood letting, probably fell into that category. Nowadays, there are much more effective remedies available but still ther must be a balance between benefit and risk. We shall not always get it right, especially as risk is not certainty. We must discuss risk with patients and involve them in the decision making. Hence it has to be communicated in a way that they can understand.
Litigation can also be a problem and can lead to the practice of defensive medicine. This is bad practice. It involves excessive invesitgation which can uncover things that would be best left alone and it adds significantly to the cost of treatment. It is rampant in the USA and where they lead, we often follow.
Advance Directives or Living Wills
Nowadays people often wish to have a say about how they are treated, even when they are no longer in a position to state their wishes. There may be brain injury or dementia. Advance directives, also known as living wills, have been part of common law but the Mental Capacity Act became law in April 2007 in England and Wales and similar legislation exists for Scotland. There is no equivalent legislation for Northern Ireland but advance directives still have legal force under common law. Not all law is by Act of Parliament. Much is traditional and called common law. Parliament has never passed an act to make murder illegal. It always has been illegal under common law. Law may also be adjusted by judges in considerations called case law. This is not so much creating new law as clarifying any ambiguities and interpreting the law. The Mental Capacity Act relates to a great deal more than just advance directives. It includes care of those who may be temporarily or permanently incapable of making their own decision. This can include those with severe learning difficulties. The test of an ability to make decisions rests on two questions:
- Is there an impairment of or disturbance in the functioning of the person’s mind or brain? If so,
- Is the impairment or disturbance sufficient that the person lacks the capacity to make that particular decision?
To be able to make a valid judgement person must be able:
- To understand the information relevant to the decision
- To retain the information relevant to the decision
- To use or weigh the information, or
- To communicate the decision (by any means)
If any part of this test fails, a person is unable to make a decision.
An advance directive, like a will, does not have to be drawn up by a solicitor but it may help to have expert advice to ascertain that it is clear and unequivocal and it fulfils all the necessary requirements. It should be signed and witnessed. Two independent witnesses are to ascertain that there was no duress. Like an ordinary will, it may also be changed at any time provided that the person is of sound mind and not under duress. As with a normal will, if it is changed, it is safest to destroy all former wills. If a doctor or relative disagrees with the decision, that is not evidence of incompetence to make the will or directive.
The mind does not have to be in perfect order as long as the person understands the implications of what he is signing. When patients have a degenerative disease such as Huntington’s chorea or Alzheimer’s disease, it is a good idea to make a directive at an early stage when faculties are still relatively good. They do not have to be perfect.
An advance directive is similar to current consent in that it cannot force a doctor to act against his conscience or to perform an illegal act. An advanced directive may allow an individual to specify in advance, that under certain circumstances he would withdraw consent for life support interventions. It would be sensible to permit such interventions at an early stage when accurate diagnosis and prognosis are unclear but if it becomes obvious that there is no realistic chance of recovery to a reasonable quality of life, that he would withdraw consent for such interventions so as to allow him to die.
Everyone with significant property or assets should have a will and it is a good time to make an advanced directive too.
A person is not permitted to state that under these circumstances he would wish to receive a lethal injection to permit him to die in peace. This is euthanasia which is still murder in law and a request for an illegal intervention is not valid. Assisted suicide is a complex ethical matter that is illegal in the UK.
Euthanasia is not quite the same as assisted suicide. My Oxford Dictionary defines euthanasia as “bringing about gentle and easy death, especially in cases of incurable or painful disease.” This may imply that a third party undertakes the act of ending the life, whereas in assisted suicide, it is the person who voluntarily takes the drink that will end his own life. This is already legal in Holland and Switzerland and many British people have gone to these countries to end their lives. The trouble is that they have to be capable of travelling there and so they may have to decide to end their lives slightly sooner than they would if it were available in the UK.
There are calls to introduce a similar law in the UK to make assisted suicide legal. Disability rights campaigners such as Tannni Grey-Thompson are vehemently opposed, suggesting that with such a law there would be intolerable pressure on disabled people to end their lives. This is nonsense. The law would have considerable safeguards, as in Holland and Switzerland, to make sure that there was no duress and that the person voluntarily wishes to end his life. This is one reason why there is no lethal injection, but a glass with a lethal concoction is placed in front of the person and he voluntarily reaches out and drinks it. There is also mandatory counselling and questions to assure that it is truly that person’s wish and there is no outside pressure. It would be mostly disabled people would use such an option.
Many who go abroad for this have motor neurone disease. The best known sufferer, but one who died naturally, was Professor Stephen Hawkins although he was unique in having the disease for longer than 50 years. A more typical time span would be three to five years. The disease affects the muscles but higher functions remain intact. Death may be due to drowning in saliva, having lost the ability to cough or swallow. The prospect of such a law has caused significant differences of opinion amongst fellows of the Royal College of Physicians.
Any such law to allow assisted suicide would be permissive, letting people make their own decisions, not compulsory. In a similar way, a permissive abortion law lets women decide. It does not compel anyone to have an abortion. Some will say that it is not an option for the baby, but it is not a baby. It is a fetus which is very different. Some people who have taken loved ones to Switzerland or Holland have been questioned by police, probably at the insistence of outside moralists, but there have been no charges brought, to the best of my knowledge.
Several years ago I had my elderly dog put down and when I went walking without him many people stopped to ask after him. When I said what had happened I was surprised at how many said, “It’s a pity we can’t do the same for humans too.” Whether they would be happy with such legislation, I do not know, but it is important to differentiate between public opinion and the rantings of a vociferous minority. It is the latter that get the media attention.
A person has the right to refuse treatment but not the right to demand treatment that is deemed excessive and inappropriate. Otherwise we may see many intensive care beds being occupied by those whose prognosis is hopeless but they could spend weeks or months receiving ventilation and artificial nutrition and hydration. This would be extremely costly and an inappropriate use of NHS resources. The words of wisdom of a consultant when I was a student back in the early 1970s still ring true. “Our job is to prolong life, not to prolong death.”
I have also heard it said, Thou shalt not kill, nor strive officiously to keep alive. An unexpected person who was reported to strive to keep patients alive when most others would have let them go in peace, was Harold Shipman, the doctor who was alleged to have killed more than 200 patients.4The Shipman reports Many would call him a “control freak” in that he wishes to decide when his patients should leave this life. Sometimes patients wanted to go too soon, and sometimes not soon enough.
An advance directive is a good time to make clear feelings about organ donation rather than leaving it to relatives at a time of great distress. If this has been done, relatives may not overrule it. When renewing a driving licence online, there is a possible direction to an NHS site to register as an organ donor but it can be done at any time. https://www.organdonation.nhs.uk
Ideally, every adult should have a will and possibly an advance directive made at the same time as well as making decisions about organ donation and putting this on record.
Just as a will has an executor, so a directive may have a healthcare proxy. This person may also have lasting power of attorney. This provision is common when a person is no longer competent to manage his own financial affairs. The role of the proxy is to see that the wishes of the individual are carried out. He does not have the power to make decisions. The wishes of the patient may not be over-ruled by relatives.
Confidentiality was included in the Hippocratic Oath, but it is still a cause for concern. Guidance, including from the General Medical Council (GMC), states that a doctor should breach confidentiality if it relates to a serious crime. If a doctor knows or suspects that a patient is a terrorist planning to kill many people his duty of care is to prevent this from happening. The problem is what constitutes a serious crime. A doctor is also under obligation to breach confidence if the welfare of children is at stake. Doctors who deal with drug abusers may find problems about confidentiality and the public good. If a patient with epilepsy continues to drive despite warnings, the doctor should inform the DVLA as someone may be killed.
I once had a patient who had been diagnosed with epilepsy and he had been informed by the neurologist, by one of my partners and by me, that he must not drive. I informed the DLVA when I found that he continued to drive and they told him to send back his licence. He continued to drive and had a fit at the wheel when driving on the M4. He crossed the central reservation and killed the driver of a car coming the other way. The victim was a man with a young family. I was surprised that he was sentenced to just 6 months in prison.
The question of confidentiality as well as ability to give consent is particularly important when dealing with young people. Young people, not yet 16 years, who come alone to see the doctor create a problem. Few would have any qualms about issuing a prescription for penicillin to treat an infection if a child of 14 years old comes alone. If an operation is required, most would want parental consent.
A common problem is a girl under 16 who requests contraception. Sexual intercourse with a minor is morally wrong and a criminal offence. The argument that to supply contraception is to be an accessory to the crime is false as the crime does not require the prescription. It will happen without it. The doctor does not facilitate the crime but reduces harm to assure that underage sex is not compounded by underage pregnancy. This is damage limitation.
Victoria Gillick went to the High Court for a ruling that bears her name although it is not what she wanted. The 16th birthday is no longer a time when a person changes overnight from incompetence to competence to make personal decisions. The doctor may treat if he is satisfied that the individual understands the implications and has adequate maturity to comprehend.5Under 16s, Consent and Confidentiality in Sexual Health Services. This is sometimes referred to as “Gillick competence”. Similarly, a person over 16 with learning disabilities may be incapable. This rule is not just for contraception but all forms of treatment.
Occasionally a doctor may have ethical objections to providing contraception. A more common problem is an ethical objection to referring for termination of pregnancy. No one should force a doctor to act against his conscience, but the patient also has the right of self-determination. She should not be prevented from having contraception or abortion because of her doctor. The doctor in this position may refuse to offer the service personally but he must refer on to a colleague, usually a partner in the practice, who has no such reservations.
An interesting case about confidentially and duty to breach it was heard in the High Court in London in early 2020. A man had been diagnosed with Huntington’s Disease (also called Huntington’s Chorea) and he had refused permission for his family to be informed. Although we tend to enshrine the principle that a person has the right to confidentiality if he chooses, I would say that morally he was wrong. There is a one in two chance that he has passed on the genetic disorder to any of his children and a further one in two chance that, if they are affected, that they would pass it on to their children. However, the law is about legality, not morality. A daughter of the man tried to sue three NHS trusts as she said that they should have informed her, and broken the confidentiality because, had she known, she would have had her pregnancy terminated. I would have thought that there was a better case for suing her father, but the trusts have more money.
The judge gave a very considered opinion which did not give a clear ruling to divulge genetic test results to others but she felt that in this case the information should have been disclosed. She said, “The duty I have found is not a free-standing duty of disclosure nor is it a broad duty of care owed to all relatives in respect of genetic information. The legal duty recognises and runs parallel to an established professional duty and is to be exercised following the guidance of the GMC and other specialist medical bodies.”6Huntington’s: Judgement on Doctors’ Duty to Tell Family It is a difficult and complex matter.
Consent means agreeing to something. If a doctor does anything to a patient without consent, this may be common assault. However, consent comes in many forms. “I would like to check your blood pressure,” says the doctor. The patient holds out an arm, the doctor wraps a cuff around it and consent is implied. However, before performing a surgical procedure, even under local anaesthetic, it is wiser to have written consent.
Consent can be a difficult issue. Nowadays we tend to use the term informed consent. How much the patient understands the relative risks of the procedure for which he is asked to consent depends upon a mixture of the doctor’s ability to communicate these risks and the patient’s ability to comprehend. People vary in how much they want to know and many are happy to leave themselves in the hands of the professionals.
An unconscious patient is brought to hospital. He is unable to give consent and there is no relative present to give it for him. A surgeon operates as an emergency and saves his life. Is he vulnerable to a charge of assault? A judge would rule that any reasonable person in such a condition would give consent if he were able. The surgeon acted in good faith, in the belief that his actions were in the patient’s best interest. He did not know at the time that the patient was a Jehovah’s Witness and he was given four units of blood. That is not a problem but if the surgeon had known the situation, it would have been rather different.
Patients are allowed to refuse life-saving interventions, no matter how ludicrous it may seem, if they are of age to consent and are of sound mind. If they are not of sound mind a section of the Mental Health Act is invoked but in a democracy this has to be used with great care.
A more difficult case, where the law does not appear to be clear, is the refusal of treatment by minors. If the child of a Jehovah’s Witness needs a blood transfusion and the parents refuse, the hospital trust can apply to have the child made a ward of court so that permission may be granted. This is usually accepted. Suppose a child refuses treatment for leukaemia. The parents want it given but the child refuses. Accepted wisdom is that a competent child may consent to treatment but may not refuse necessary treatment. However, this position is unclear.
Issues of how strongly to strive to keep alive are not limited to the elderly or those with terminal diseases. An ethical dilemma that has resulted from the success of medical science, is how diligently staff should try to maintain babies who are born very prematurely and possibly also small for their gestational age (for that time of pregnancy). Advances in neonatology have meant that more are able to survive but there is a question of the quality of life. Survival figures hide considerable disabilities in such children. Learning difficulties, motor skills delay and damage to hearing and sight are rather common. The article in PatientUK on 7Premature Babies and their Problems is written for doctors, but others should still find it comprehensible and interesting. It is another update of an article that I wrote originally.
Outcomes depend on such matters as how premature was the baby, how much did the baby weigh, and if the baby was light for gestational age (duration of pregnancy). Hence it is inappropriate to give a single figure for those with moderate to severe disability. There are two problems with prematurity. One is being too early. The other is being too small for that duration of pregnancy, being starved by an inadequate placenta. The article draws attention to a paper from France, but in English in the BMJ looking at 8Neurodevelopmental outcome at 2 years for preterm children born at 22 to 34 weeks’ gestation in France in 2011. The conclusion is, “In this large cohort of preterm infants, rates of survival and survival without severe or moderate neuromotor or sensory disabilities have increased during the past two decades, but these children remain at high risk of developmental delay”. It is imperative that neonatology units are judged not only on survival rates but on the quality of life.
Not all babies who are premature do badly. Examples from history include Albert Einstein, Isaac Newton and Charles Darwin. Nevertheless, serious ethical questions are raised. When should neonatologists decide that the quality of life that they salvage is not worth the effort?
In this rapidly changing world, with constant scientific advance, the General Medical Council (GMC) now places much emphasis on doctors keeping their practice up to date. Living in the past is no longer an option and evidence-based practice must be part of routine practice. They regard this as an ethical imperative.
Animals in Medical Research
Ethics in research may be divided into research with animals and research with humans. We have seen from the chapter A Very Brief History of Science and Medicine that Galen and many successors dissected live animals. This sounds horrific but standards were different then and even operations on humans were conducted without any anaesthetic until the mid-19th century. However, at least the operation on a human was supposed to be for his benefit.
The British have always been rather sensitive about the use of animals. In 1876 there was outrage in Britain about the use of horses to practice surgical technique in France and this led to a system of licensing by the Home Office for those who wished to work with animals. The French and the British had rather different attitudes. The French took the line of St Augustine, supported by Descartes, that animals do not have a soul. Although the British might not attribute a soul to an animal, they were more influenced by Darwin’s “On the origin of species” and so held animals as being more related to ourselves. The law of 1876 has been updated several times, the last occasion being in 1986. Under the 1986 Act, project licences are only granted for specified permissible purposes:9The Home Office Research and testing using animals.
- Where there are no non-animal alternatives
- When the benefits expected from the programmes of work are judged to outweigh the likely adverse effects on the animals concerned
- The number of animals used and their suffering must be minimised.
There is a code of practice relating to animal experiments. This includes the care and housing of laboratory animals, which include breeding and humane killing.
- Each person who undertakes work under the Act must hold a personal licence
- The programme of work must be authorised in a project licence
- The places where scientific procedures are carried out must be licensed under a certificate of designation
In the Book of Genesis, God tells Adam to name the animals.10(Genesis chapter 2 verses 19 and 20) This is significant because according to ancient Jewish tradition, if a man was asked to name something or someone it gave him responsibility for what he named. This does not mean that animals are equal to man but it does mean that he has a duty to treat them responsibly. He may use them for meat, for skins, as pets or for scientific research but he should not, in any of this, cause unnecessary suffering. There may also be a responsibility to avoid the extinction of some of the more wonderful animals, especially mammals that are endangered such as the large cats, the white rhino, the blue whale and some primates which are our closest relatives. There are many thousands of species and some must come and go in accordance with evolution. The extinction of the smallpox virus is a cause for rejoicing, not regret.
There are some who take a rather more extreme view about the rights of animals although many of them are not vegetarians. Those who see animals as having rights are generally viewed as somewhere between eccentric and deranged. However, there are some who even take to terrorism in the name of animal rights. These people must be treated like any other terrorist and energetically hunted down and put out of action.
Animal testing for cosmetics has always brought controversy. If it really is unnecessary, why would cosmetic companies bother with the expense? Some retailers proudly announce that their products are not tested on animals. So who are they tested on? Is it humans? Is it their paying customers or are they just not tested at all? In 2003 the European Union brought in a ban on the use of animal testing for cosmetic to start from 2009.11EU bans animal testing for cosmetics However, companies were allowed to test for allergies or carcinogenesis (causing cancer) at least until 2013.
Searching the Internet for information about the use of animals in research is a classic example of where the Internet provides a vast amount of information but much of it is misinformed and extremely unbalanced. The concept of “vivisection” is usually frank lies. Some academic departments and pharmaceutical companies try to put their side of the story and the reader is advised to read them, if interested, and not to be limited to the more vociferous outcries. If we really could do without animal experiments the industry would. It is the source of much friction and costs a lot of money. Why bother if it really is unnecessary?
There are occasions where not only are animals the only rational experimental model but primates have to be used. This applies especially when studying disease of the brain. This is a particularly contentious issue and the Home Office Animal Procedures Committee has made recommendations.12The Home Office. Animal Procedures Committee
Humans in Medical Research
There have been some horrific examples of unethical research on humans in the past but the concept of ethics in research is comparatively recent. This has grown since the end of the Second World War. The Nazi doctor, Josef Mengele worked at the Auschwitz concentration camp where he performed a number of horrific experiments on prisoners there.13Medical Experiments of the Holocaust and Nazi Medicine The Japanese behaved appallingly in many ways during the Second World War but their Unit 731 is said to have been the most depraved. Their crimes included using prisoners as subjects to develop biological and chemical warfare and then dissecting them whilst still alive. In the autumn of 1945, General MacArthur granted immunity from prosecution for war crimes to members of Unit 731 in exchange for data of research on biological warfare.14Japanese Unit 731. Biological Warfare. It is amazing what can be forgiven in the name of political expediency.
Josef Mengele, the most infamous Nazi doctor
In 1997 President Bill Clinton publicly apologised to all those who had been affected by the Tuskegee experiments.15Studies show ‘dark chapter’ of medical research The Tuskegee study, which began in the early 1930s, consisted of 399 African-American men with syphilis and 201 without. The Tuskegee Institute partnered with the Public Health Service for an experiment that was supposed to last 6 months. In fact it was not stopped until 1972. The concept was overtly racist but the worst part was the denial of treatment for syphilis that has been available since penicillin has been available.
The notorious Japanese unit 731 pose proudly for a photo
The trials of many Nazis for war crimes occurred in Nuremberg and a code of conduct called the Nuremberg Code has been developed. This includes a number of important features:
- Voluntary consent of human subjects is absolutely essential. There must be no deception or coercion.
- The results should yield valuable information for the good of society and data cannot be obtained by other means.
- The degree of risk should never exceed what is proportional to the humanitarian importance of the problem to be solved by 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 that continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
This list is by no means exhaustive.16Fifty Years Later: The Significance of the Nuremberg Code There are four principles to be observed, according to later authors. These are respect for autonomy (self-determination), non-maleficence (doing no intentional harm), beneficence (the interests of the individual at heart), and justice.
Ethics committees were formed to oversee research. They have also been known as Institutional Review Boards and this term is still used in the USA. At first they were regarded as an optional extra but nowadays all research must be approved by an ethics committee before it is started. This is compulsory within the NHS and funding for research will not be granted until ethics approval has been won. Without ethics committee approval no reputable journal will publish the findings. The research ethics committee is to protect the rights, dignity, well-being and safety of all participants in the study. They also recognise the interests of the researchers who aim to contribute worthwhile information for the public at large. The interests of the participants are primary and those of the researchers are secondary. The members of such committees include scientists so that they understand research but there are also lay members. It is a very demanding and responsible position.
One of the matters that the committee will consider is if the research project is sound. The argument is that it is not ethical to ask people to participate in poor research as it will not advance knowledge. Indeed, if poor research is published it may even mislead. Sometimes there is a temptation for researchers to “massage” their results to give the outcome that they want. Occasionally they may even be frankly fraudulent. Anything short of complete honesty is severely depreciated and the GMC takes a very stern line on fraud in research. It argues that if a doctor is incompetent this will have an adverse effect on a limited number of patients. That is not to condone incompetence. Fraudulent research may have much more wide reaching consequences, leading to a great many people being inappropriately treated.
Research should also be presented to a journal for publication as patients have gone to the trouble of participating. We have seen with regard to How Good is the Evidence? as well as the section on meta-analysis in Randomised Controlled Trials that negative results are often not reported. This may be because the researchers think that the failure to prove their theory is not worth reporting or because the pharmaceutical company that funded the work does not want papers that are unflattering to its products to be printed. All this results in a biased view of the evidence which leads to inappropriate recommendations and harm to patients. This is unethical.
Research dishonesty and downright fraud may not be as rare as we would like to believe. It is difficult to know the true figures and it probably varies between countries and cultures. There have been a number of gross cases over the years.17The 10 Greatest Cases of Fraud in University Research
A certain degree of “massage” of results is very tempting but is not acceptable. In 1936 the statistician RA Fischer argued that Mendel’s results were “too good” and wondered if the monk may have been less than entirely truthful.18(Fischer RA., 1936 Has Mendel’s work been rediscovered? Ann. Sci. 1:115-137) Mendel has had his supporters19On Fisher’s Criticism of Mendel’s Results With the Garden Pea and the matter is far from certain but it does illustrate the point that if something looks too good to be true, it is probably not true.
It is rare for serious harm to result from medical experiments. When this happens the scientific world looks at the methodology and asks if something may have been done better to predict or reduce the risk of such an occurrence. This happened in March 2006 in a clinical trial in Northwick Park Hospital in London. The drug had been extensively tested on animals and no serious adverse effects had been found. The drug, known as TGN1412 at the time, is a very potent monoclonal human antibody that binds to the thymus dependent lymphocytes. In short this means that it is a human antibody that binds to white blood cells that play a very important role in the body’s immune system. Its exact nature is unimportant. What matters is that six volunteers who received the drug developed multiple organ failure. Two received placebo and were unharmed. One man was in a coma for 14 days. He spent 140 days in hospital and had fingers and toes amputated for gangrene. An editorial in the BMJ discussed the significance of this event.20Learning from the TGN1412 trial
One suggestion to have arisen is that in such experiments, subjects should have the administration of the drug staggered so that if an immediate and catastrophic reaction occurs, it will be seen before all have received the substance. The drug was being developed to treat both chronic lymphatic leukaemia and rheumatoid arthritis. Such events are very rare considering the amount of research that happens every day but when they do occur it is right that much consideration and recommendation should occur to reduce, if not completely prevent, further such disasters. These subjects were not patients with a serious disease but previously healthy volunteers. The drug bound to the CD28 receptor of T-cells or thymus dependent lymphocytes. These are important in the immune process. It later transpired that another drug that bound to those receptors had produced some serious adverse effects in the past but because the drug was developed no further this did not reach the literature. There has been a call to compel making the results of all first in man testing available for other researchers to give forewarning of such events.
The opponents of animal experiments immediately cited this tragedy as a reason why animal experiments are useless and should be stopped. It is amazing how ridiculous a conclusion may be reached by those with closed minds. How many more of these serious adverse events would have happened if we went into human trials without first using animals? If animal experiments were a perfect model there would be no need for human trials or even post marketing surveillance.
Another area where animal experimentation may fail to show the whole picture is teratogenesis. This is the possibility that a substance, if given in pregnancy, may cause deformity in the baby. The classic example of this was thalidomide. Animal testing had not shown problems.21Utilization of animal studies to determine the effects and human risks of environmental toxicants However, there has been doubt expressed that it was properly tested on animals before being marketed.22The history of thalidomide Nowadays thorough testing is mandatory and yet there may still be problems that we do not appreciate until after the drug is widely used. It is standard practice that all new drugs should be avoided in pregnant women, especially in the first 3 or 4 months of pregnancy when the organs are developing and the risk is greatest.
Post-marketing surveillance is imperative for both manufacturers and the regulatory agencies. Roficoxib, better known by its trade name Vioxx was withdrawn in 2004 after reports of excessive risk of heart attacks and stroke. It was used for pain, especially in arthritis. The diabetes drug rosiglitazone, known by the trade name Avandia, was withdrawn in 2010 after an apparent increase in risk of heart attacks, heart failure and stroke. In both cases the pharmaceutical companies involved have been criticised for trying to hide the risks although in doing so they may have been building up more cases for litigation. Constant vigilance is required. For substances that are not subject to medicine regulation such as herbs and supplements there is no such safeguard.
There is concern about what gets published in scientific journals. This may include work in which figures have been “massaged” to give the sought after result but also there is concern about what does not get published. If only positive results are published we may be led to believe that a drug is effective when it is not. It is said that research that is funded by pharmaceutical companies tends to be more positive than research that is not. There is concern that bad news is suppressed and this will mislead the reader and anyone who performs meta-analysis23Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses although funnel plotting with cut and fill has been mentioned.
A few decades ago the word “governance” was found only in the Book of Common Prayer. This was not much changed since the original by Archbishop Thomas Cranmer, the first primate of the new Church of England under Henry VIII. It was completed in 1549 and it includes the wonderful lines “That we should do always as according to thy governance”. Now we have clinical governance, research governance and corporate governance. Clinical Governance is a system by which doctors and clinicians adhere to a set of rules to assure a high quality of care for patients. Research governance means good and honest research, ethically conducted. Corporate governance is when companies have rules to obey in terms of book keeping, openness and honesty and maintaining high standards in commercial life. Basically it means obeying the rules and doing things in a correct and commendable manner.
Ethics may be a bit “touchy feely” but it is still a basic condition that should underpin all activity, whether in research of practice. It is about how world.
Research on Children
Research in children poses some ethical conundrums that are not present in research on adults. 24Medical Research in Children These relate largely to the question of consent. We have seen that children do not suddenly become competent to comprehend and consent on their 16th birthday but there is a gradual maturity. There is also the question of asking them to submit to something which may not be in their own interest, but hopefully in the interest of others in the future. Back in the 1960s, I used to wonder why we gave four very unpleasant and toxic drugs to children with leukaemia, giving them nasty side-effects and they still died. However, by the 1980s the survival rate in acute lymphoblastic leukaemia, the commonest leukaemia in children, had reached about 90%. This is the rate of cure, not remission. Nowadays we look at such matters as possible fertility when they become adults and would like to have a family. The research has brought incredible results. In fact, the results of most common cancers has improved considerably in recent decades except for lung cancer, but better than cure, we have known how to avoid about 80 or 90% of cases since the 1960s. There are some non-smokers who get lung cancer, but they are a small minority.
Children are not just little adults.
Their metabolism may be different.
Their brains may respond
During my years in practice I have come across a number of children, teenagers and young adults who have had cancer. They are at an age where it is very common to be self-absorbed and selfish. Their initial response is one of anger, which is understandable. “Why me? Cancer is supposed to be a disease of old people. I am young and supposed to have many years of life ahead of me.” After a while and with sensitive management they comply with treatment and realise that people are doing all they can to help them. At this egocentric age, they end up being more concerned about their families and the ones they love than themselves. No one who has cared for a young person with cancer can fail to be deeply moved by the experience.
Not all research in children is on drugs or treatments for cancer or other fatal diseases. All drugs to be used on children must be tested on children. It is not acceptable to regard them as just mini-adults. Their metabolism may be entirely different and for psychotropic drugs, the response of the immature brain in children may be totally different from that in adults. Again, there is a question of informed consent and something that may not be of direct benefit to the child being investigated. Parents can give consent along with the child when they are able to understand, which may be when they are quite young but not babies. We must have research on children to treat children.
An example of the inappropriate use of data from adults being extrapolated to children arose in the Cleveland child sexual abuse scandal of 1987. Dr Marietta Higgs, consultant paediatrician, arrived at Middlesbrough General Hospital on 1st January 1987 and immediately the number of reported cases of child sexual abuse soared. She put pressure on her colleague, Dr Wyatt to do likewise. The basis of the diagnosis was a physical sign called “reflex anal dilatation.” If the patient is on the side with legs drawn up to the chest and the buttocks are parted, the anus winks at the observer. It was a test that was used in clinics for sexually transmitted diseases to diagnose adults who were receptive male homosexuals. The technique had never been validated as a test for child sexual abuse.
Children were put through the test when there was no indication of possible abuse, including some who presented in the Accident and Emergency Department with acute asthma. There are many other features that may suggest that a child is being abused but even in their absence a diagnosis was made and many children were taken into care. I would suggest that both the unwarranted examination and taking into care a child who vehemently denies abuse and has no other features of it, is abuse. Furthermore, many innocent fathers were presumed to be the perpetrators and faced the wrath of wives, families and neighbours. The scale of this was quite appalling and social workers seemed complicit although police questioned the apparent sudden epidemic.
Eventually it did come to a head, after much damage had been done. Dr Higgs blindly maintained her assertions but others stepped in to bring sanity. The GMC were obliged to undertake a damage limitation exercise, not for the children, but for their own failure to intervene. The government set up an inquiry under Judge Elizabeth Butler-Sloss and its findings show an incredible series of failures in so many ways. 25The Cleveland Report: by Judge Elizabeth Butler-Sloss
I have seen reflex anal dilatation in a child but the diagnosis was quite clearly severe constipation. This sad story shows a mixture of inappropriately extrapolating from adults to children and a severe lack of self-criticism and insight.
We need research in children to help other children. It must be based on honesty and good-will. Even in the most difficult of times there is much altruism to be found.
The British legal system is adversarial. There is counsel for the prosecution versus counsel for the defence in criminal cases and for the plaintiff and the defence in civil cases. At times there may be matters where the court needs advice from experts on a very wide range of possible issues. These may well include the interpretation of medical evidence. In the past, both sides would provide their own experts who would argue the case for their side in as partisan a way as would the lawyers. In 1996, Lord Woolf, Master of the Rolls, produced a very sensible report which argued that the system of conflicting experts should be replaced by a single joint expert if both sides agree.26(Access to Justice: Final Report by the Right Honourable The Lord Woolf, Master of the Rolls. London: H M Stationery Office, 1996)
The expert witness is there to help the court to understand difficult and possibly complex and technical issues. He helps the judge and jury to make informed decisions.
The single joint expert (SJE) would be answerable to the court rather than to the side that retained him. Retained is a legal euphemism meaning that they paid him. This had the advantages that the experts were not biased and selective in their interpretation and costs were reduced by having just one and not two experts. It is important that the expert remembers that his duty is to the court, to provide a balanced opinion, and not to his paymaster. Being an expert witness can bring in a significant extra income for the work but there are considerable responsibilities that accompany this. He must read around the subject and give considerable thought to the case. It must be an honest and unbiased assessment. The outcome of a case may depend upon it. One way I have heard it put is, “My time is for sale. My opinion is not.”
In television dramas, such as Silent Witness it is common to find a barrister giving a hostile cross-examination to the expert witness. I believe that in practice, this is most unusual. The expert witness is an expert and unbiased adviser to the court and to be afforded respect and aggressive confrontation by a counsel will lead to rebuke from the judge, except in exceptional circumstances.
I have done a significant number of expert reports giving written testimony rather than evidence in court, although I could have been summoned if there was disagreement and the matter came to court. Most, but by no means all, were for people who had been in road traffic accidents and in many cases the complaint was of whiplash injury to the neck after a rear-end shunt. I agree with those who say that this has become a scam, with far too many claims of a minor nature resulting in us all paying significantly more for our insurance premiums as a result. There is not just the compensation to the alleged victim but the fees for the expert and the lawyers. I used to ask about the extent of damage to the cars to get an indication of the severity of the impact. There seemed to be very little correlation between the extent of damage and the reported disability. Some people would minimise their injuries. They would take some paracetamol, keep their necks moving and get on with life. Others would “lay it on with a trowel”, making a great deal of a minor injury and really delaying heir recovery.
I was never privy to the value of compensation, but I thought it was most unfair if those with a positive attitude received little whilst those who delayed their recovery were rewarded for it. I remember one woman who had a fairly minor injury and took to her bed for the next two days. I reported that she had aggravated her injury and delayed her recovery. Her solicitor was most unhappy with this and tried to pressurise me to change my report. They even considered getting another opinion, but this could not be done without both reports being presented. It is not possible to choose which expert opinion you would like.
Only once have I had to appear in court, and this was a magistrate’s court on a totally different matter. A young man had been drinking in a pub and as he was about to leave the car park a police officer tried to flag him down. Instead of stopping, he accelerated towards the officer and narrowly missed him. This was quite a serious charge.
His defence was that a friend had put two capsules of Xanax (alprazolam, a benzodiazepine in the same class as diazepam) in his pint of lager and this had led to his aggressive behaviour. I was “retained” by the defence. In court the defence started by asking me if drugs such as that could lead to uncharacteristic behaviour that would not otherwise have occurred. I explained about release of inhibitions. I had done my reading on the subject. They seemed well satisfied and it was the turn of the prosecution who had no further questions. I was shocked. “He’s getting away with it,” I thought.
There were three elderly magistrates on the panel and the lead one said to me, “May I ask you some further questions, doctor?” He asked if someone had put the contents of these capsules in a drink, would he notice it. Again, I had done my homework and tried it the night before. Instead of two capsules in a pint of lager, as was alleged, I tried the contents of half a capsule in a quarter of a pint of lager. There was no point in ruining three quarters of a pint of lager unnecessarily. I explained that when I did so the powder floated on the top. I gave it time to dissolve but when it did not, I took a teaspoon and stirred it up. “Did it dissolve completely?” asked the magistrate. I replied that it did not but formed a cloudy suspension and if anyone was served that in a pub, he would send it back. “Would it have been possible to taste it?” he asked. I said that I had a sip and it was ghastly. Never underestimate elderly judiciary.
I had my fee in my pocket, in cash, and I took my leave. This rather crass lie had been destroyed. I was glad that I had thoroughly researched my brief.
- The Home Office. Research and testing using animals.
Home Office web page for those seeking to apply for a licence for animal use. There are links to the Act, code of practice and the operation of the Act.
- General Medical Council. Ethical Guidance for Doctors.
Advice from the GMC about what constitutes good medical practice and hence what falls short.
- General Medical Council. Good practice in Research and Consent to research.
It sets out the good practice principles that doctors are expected to understand and follow if they are involved in research.
- Premature babies and their problems. Dr Anjum Ghandi. Patient UK.
Written for doctors but comprehensible for others. Update of an article that I wrote originally.
- Contraception and Young People. Mary Harding. PatientUK.
Again it is written for doctors but it should be interesting for others too.
- I have been very brief about Josef Mengele and Japanese unit 731. If you want to know more, put them in a search engine but be prepared for some very distressing information and images.
- BBC religions. William Wilberforce.
- Sritharan K, Russell G, Fritz Z, Wong D, Rollin M et al. Medical Oaths and Declarations. BMJ. 2001 December 22; 323(7327): 1440–1441.
- Joseph S. Patients or Clients? Psychology Today. 4th August 2013.
- BBC News. At-a-glance: The Shipman reports. 27th January 2005.
- Under 16s, Consent and Confidentiality in Sexual Health Services. Family Planning Association. 2016https://www.fpa.org.uk/factsheets/under-16s-consent-and-confidentiality-sexual-health-services
- Huntington’s: Judgement on Doctors’ Duty to Tell Family. Medscape 3 March 2020
- Ghandi A. Premature Babies and their Problems. PatientUK professional resources.
- Pierrat V, Marchand-Martin L, Arnaud C, Kaminski M, Resche-Rigon M, Lebeaux C et al. Neurodevelopmental outcome at 2 years for preterm children born at 22 to 34 weeks’ gestation in France in 2011: EPIPAGE-2 cohort study. BMJ. 2017 Aug 16;358:j3448. [full text]
- The Home Office. Research and testing using animals.
- Book of Genesis Chapter 2 verses 19 and 20.
- BBC News. EU bans animal testing for cosmetics.
- The Home Office. Animal Procedures Committee.
- Medical Experiments of the Holocaust and Nazi Medicine.
- Japanese Unit 731. Biological Warfare.
- CNN News. Studies show ‘dark chapter’ of medical research.
- Shuster E. Fifty Years Later: The Significance of the Nuremberg Code. N Engl J Med 1997; 337:1436-1440 November 13, 1997.
- The 10 Greatest Cases of Fraud in University Research. Onlineuniversities. 27th February 2012.
- Fischer RA., 1936 Has Mendel’s work been rediscovered? Ann. Sci. 1:115-137
- Novitski E. On Fisher’s Criticism of Mendel’s Results With the Garden Pea. Genetics, Vol. 166, 1133-1136, March 2004.
- Goodyear M. Learning from the TGN1412 trial. BMJ 332 : 677 doi: 10.1136/bmj.38797.635012.47 (Published 22 March 2006) [full text]
- Brent RL. Utilization of animal studies to determine the effects and human risks of environmental toxicants (drugs, chemicals, and physical agents). Pediatrics. 2004 Apr;113(4 Suppl):984-95.
- Botting J. The history of thalidomide. Drug News Perspect. 2002 Nov;15(9):604-611.
- Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ2012;344:d7202.
- Medical research involving children. document title 2003 MRC Ethics Guide 2004.
- The Cleveland Report: by Judge Elizabeth Butler-Sloss. The Therapeutic Care Journal. 1 August 2011
- Access to Justice: Final Report by the Right Honourable The Lord Woolf, Master of the Rolls. London: H M Stationery Office, 1996
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