Public Trust in Medical Research?

Ethics, Law and Accountability

Philip Cheung, S. H. Lee

• Publisher: CRC Press
• Year: 2018
• ISBN:
  9781315357423
• Edition: 1
• Topic: Medicine
• Subtopic: Public Health, Administration & Care

It has been claimed by fertility experts that embryos can be screened for 6, 000 diseases, thereby the risk of x-linked diseases can be minimised by 'cherry-picking' male embryos that do not carry the abnormal gene. If medical scientists continue to strive for cures, genetic aberrance in human could be a phenomenon of the past...This challenging book explores issues of professional integrity and ethics underpinning medical research. It includes real-life case studies where public trust in medical research has been misplaced and encourages medical professionals to adhere to professional codes of conduct and be informed about their decision making process. It is vital reading for undergraduate and postgraduate students of medicine, law, sociology and social policy, philosophy, health related research and ethics. Practising researchers in medicine and the pharmaceutical industry, and their managers will find it invaluable. The text provides motivation for academics and educators with an interest in research and governance. Healthcare policy makers and shapers, patient rights groups, campaigners and the general media will find the information enlightening. "Over the last four decades, medicine has given hope to many people and saved many lives as a result of the ability of the physicians and surgeons to develop new treatments and innovative surgical techniques. While we can celebrate the success of medical science, we should also critically examine some of these developments against principles and in the light of public opinion." - Philip Cheung.

Chapter 1

Medical progress and human costs

Issues of medical progress

If we look back over the last four decades, medicine has given hope to many people and saved many lives primarily as a result of a better understanding of diseases, due partly to a rapid advancement in biochemistry and biotechnology and the ability of the physicians and surgeons to develop new treatments and innovative surgical techniques. The advancement in biochemistry and biotechnology in particular has contributed to a range of innovative medical treatments including the possibility of conquering some of the genetically inherited conditions. It has been claimed by fertility experts that embryos can be screened for 6000 diseases, thereby the risk of x-linked diseases can be minimised by ‘cherry picking’ male embryos that do not carry the abnormal gene. If medical scientists continue to strive for cures, genetic aberrance in humans could be a phenomenon of the past.

Medical science has made advances into childlessness. For example, the in vitro fertilisation technique or IVF has conquered the problem of infertility. Eggs can now be frozen for women who desire to delay their motherhood. Researchers in Newcastle upon Tyne, UK, have been able to grow sperm from mouse embryonic stem cells and use them to fertilise eggs, resulting in seven mice being born. In due course, the new technique developed by the Newcastle team may be applied to treat male infertility problems. The possibilities are limitless.

One can safely say that most, if not all, innovative medical and surgical treatments are underpinned by painstaking research, including the development of new drugs, which has played a significant role in the management and control of the disease process. During the course of these scientific developments, members of the public are directly or indirectly involved either as donors to, or as recipients of, a new surgical procedure. For example, prior to the introduction of heart valve replacement surgery as a safe practice in the early 1960s, heart valves were salvaged from the deceased for technical and experimental purposes. Once the technique was perfected, many patients benefited from freeze-dried homografts obtained from healthy hearts of deceased persons. Since then, the transplantation of major organs has been mastered and with the help of immunosuppressive drugs, organ transplantation of heart, lungs and liver can now be offered as a safe surgical procedure. Scientists have now turned their attention to using embryonic stem cells (ESCs) obtained from a person for the manufacture of whole organ autograft, which could be a real alternative as donor organs are in short supply.

While we can celebrate the success of medical science, should we not also critically examine some of these developments against specific criteria or principles and in the light of public opinion? One of the questions that needs addressing is whether there are human costs associated with medical advancements. Consider for example, the first-in-man clinical trials¹ carried out by Parexel, a contract research organisation, in March 2006. (The term ‘first-in-man trials’, ‘first-in-man studies’, ‘first-in-man clinical trials’ and ‘Phase One clinical trials’ of high-risk medicines are used by the Expert Scientific Group on Phase One Clinical Trials, interchangeably.) Eight healthy volunteers were used for the trial. Six of them were given the untested drug TGN1412, which is a monoclonal antibody developed for the treatment of chronic inflammatory or immune conditions such as rheumatoid arthritis and leukaemia.¹ Within minutes of the drug administration, a violent allergic reaction, referred to scientifically as a cytokine release, occurred and the six healthy volunteers were left fighting for their lives.

The technique of culturing or cloning antibodies was developed in the late 1970s. It involves injecting a mouse or other type of animal with a particular allergen, i.e. the mouse is immunised and a range of antibody-producing cells is triggered as a result. These antibody-producing cells normally die after a few divisions, so are not useful for producing large quantities of antibodies. But if a specific antibody-producing cell from the immunised animal is combined with a myeloma cell – an immune system cancer – then the fused cell when cultured in a special medium can produce large quantities of antibodies.²

It might seem reasonable for a doctor to offer a treatment of unproven efficacy to a sick person with a limited life span in exchange for a possible recovery or a better quality of life. On the other hand, is it reasonable to subject healthy people to unknown risks as in the TGN1412 trial? If the six healthy volunteers had died as a result of the trial, the costs to the families would be incalculable, even though the experiment was carried out in the name of medical science. Is there a compromise between medical progress and human costs? One might suggest that if individuals are unwilling to make sacrifices, progress in medical research could be seriously jeopardised and more people will suffer in the long term.

Limits of medicine and medical research

Some of us seem not to be content with the notion that the human body has a natural lifespan and are reluctant to face the reality of death and the pursuit of immortality becomes a human obsession. Advancements in science and medicine tend to give the impression that immortality can be within our grasp. It was thought 30 years ago that someone suffering from coronary thrombosis would have to be content with the prognosis, i.e. the person would succumb to the disease. Now, coronary bypass surgery is a well-developed technique and the survival rates after bypass surgery are high. The technique of replacing a diseased heart has been perfected and many patients continue to live for an extended period. Surgeons are now able to perform multiple organ transplantations providing donor organs are available. The public may gain the impression that sparepart surgery is an essential service provided by the health service alongside other more mundane services such as geriatric care and community care for the mentally ill. The doctors who are specialising in this field of surgery will want to achieve the impossible by, for example, multi-system surgery, with the help of pharmaceutical products conquering the biochemistry of tissue rejection.

Human society, at least in the developed world, is reluctant to accept the inevitability of dying. Dying could be considered as part of the human growing process. Is it good medicine and ethical to use considerable amounts of money to extend lives, sometimes putting the patient through an assault course in the process, in return for postponing death? Should some of the health service resources be reallocated to those who are old and infirm, to those who are mentally ill, to try to improve their quality of life? Chronic geriatric and psychiatric medicine in particular are seen as less prestigious fields of practice. Since the health service is strapped for cash, and transplantation surgery is often carried out at the expense of other branches of medical practice such as orthopaedics, geriatric or community medicine, should resource distribution in the health service be re-examined? Should the principle of resource allocation be based on fairer distribution, that is, should funds be allocated to medical interventions and treatments where the greatest numbers will benefit in society? Is there an ethical dimension to the use of National Health Service (NHS) resources?

The Department of Health pledged to double kidney transplants and increase heart and lung transplants by 10% by 2006. However, the targets are unlikely to be met as the current trend shows that at the end of March 2006, 6698 people were still waiting for transplants, a 9% increase compared to the previous year. There was a decrease of 9% in heart and heart/lung transplants compared to the previous year.³ Those who are in the field of transplantation surgery expressed their anxiety, particularly following the Alder Hey, Bristol and other organ scandals. The Department of Health has an obligation to encourage more donors to come forward otherwise this life-saving technique is at serious risk. It seems to me that one needs to take stock of the current technology-based medicine and consider its real value against other significant health needs.

To give life to another person through organ donation is a praiseworthy act. Donor organs normally come from largely healthy persons whose life is suddenly cut short, usually due to a road traffic accident, head injury or suicide for example. They may also come from someone who is in a vegetative state, which is described as ‘someone living like a vegetable, without will or consciousness; functioning involuntarily’,⁴ i.e. in a state of human non-being. This human non-being state can be maintained for as long as necessary by mechanical means until suitable recipients are found for transplantation. When suitable recipients are found the life of the human person artificially kept alive can be ended at will by a team of competent surgeons. Is this ethically permissible? Is this a decent death? A couple of views from those who have experienced organs being given for transplantation show how complicated are the issues in practice.

A 64-year-old man speaking of his wife, stated: ‘She had never died. She died when the organs were donated.’

A mother in her late forties consented to her daughter’s organs being used for transplantation. She later explained: ‘To me, donating meant killing my child.’

(Notes from author’s personal diary)

The message given by the above individuals touches the affective aspect rather than mechanical aspect of organ donation. The scientists and doctors are looking at the human body from the usefulness point of view. It is an object worthy of being salvaged. From the donor relatives’ point of view, they are talking about a person with a unique presence prior to becoming brain-dead. The human suffering associated with the advancement in transplant surgery can be inestimable for the deceased’s relatives. There is no human compensation from their point of view even through altruism. Though this may not be the only or indeed the ‘normal or standard’ reaction, since there are relatives who have spoken positively of the psychological aspect of donation, it is important evidence of the emotional, human and ethical situation for some individuals.

Consideration of the method used by clinicians in obtaining donor organs for transplantation surgery from the relatives of a person in a vegetative state and the emotional aspects of giving described above are not intended to deter individuals from such an act, rather to raise awareness of the serious human effect that may follow. Perhaps many of us have not even given such a matter any serious attention. Sometimes emotions overcome reason when such a decision is put to us. How does one react to such a request when it occurs?

There is in general avoidance of talking about death and dying, a subject that it is not comfortable to discuss at home, in schools or in hospitals. Opportunities are rarely provided even in a religious setting. Even those whose training or background qualify them as experts see death and dying as taboo. Death is the fate of humanity and yet it is not well understood. If one were to adopt Galen’s notion that the human body is a machine and able to be repaired, then the idea of immortality would be a real possibility, at least in terms of bioscience and medicine. Human immortality then becomes a scientific challenge. Should medicine be primarily concerned with prolonging life even if the limits are stretched? What about those who are in need of terminal care? Assisting someone to die peacefully and with dignity should be seen as being as praiseworthy as saving a life. Why are doctors and scientists so obsessed with conquering death?

Major events in recent years such as the Bristol Royal Infirmary Inquiry into children’s post-operative death following cardiac surgery, the Royal Liverpool Children’s Hospital Inquiry into organ retention (Alder Hey) following postmortems and the Inquiry into the removal and retention of adult brains for research brought about by Cyril Isaacs’ widow (these events will be discussed in Chapter 5) provided a platform for a long-awaited public debate regarding the essence of specific medical practices and the basic philosophy of medicine and medical research. They have provided an opportunity for interested members of the public and society in general to examine some of the basic human values inherent in medical practice and research which we, as users of the health service, care deeply about.

The Alder Hey, Bristol and Isaacs families have been asking many of the same basic questions as faced by philosophers and other thinkers. For example, the families have provoked us to explore more deeply the issues of human society and human practices, particularly in the world of medicine. They challenge the idea of human existence, our place in the world, the meaning of life and, like the theologians and philosophers, they ask questions about death as well as life. The biologists and medical scientists have also been challenged as they confront the belief which seems sometimes to be held by some researchers that the body is merely made up of a bag of genes. More fundamentally, they are delving into the very root of basic human values governing human practices in society: the existence and purpose of rules in human society and what rules exist and to what extent these rules should help curb individual selfishness and inclinations. The whole notion of scientific progress in the name of common good has been seriously challenged.

Daniel Callahan, Director of International Programmes at the Hastings Center in Garrison, New York, a centre that has five research programmes specialising in ethics and scientific research, spoke a few years ago to the Nobel Laureate, Joshua Lederberg, on the issue of medical research. In his article ‘When science is just another good cause’, published in the New Scientist, he recalled the remark made by Lederberg: ‘Those who do not support medical research will have the blood of those who die on their hands.’⁵ Lederberg’s claim might sound melodramatic but similar claims have also been made by some doctors and pathologists involved in organ retention as justification for continuing a widespread inappropriate and unlawful medical practice that has brought a great deal of unnecessary human suffering.

Whenever families in Liverpool and elsewhere in the UK asked why doctors and pathologists needed to take everything from the child’s body, the reply was that the organs retained would help the study of genetic diseases or other rare conditions. The implication is that without these organs doctors would not be able to help others and that anyone who raised objections to organ retention would be subjected to Lederberg’s emotional blackmail. Lay people might find the rehearsed argument from doctors difficult to resist. Even those with doubts, or who had reached a different point of view after much thought, might feel they ought to be persuaded.

A statement was made at the Chief Medical Officer’s Summit in January 2001 by a former CMO about the importance of having access to archive collections of organs. He said: ‘HIV and AIDS, variant CJD, certainly could not have been recognised without access to such collections.’⁶ This might have an element of reality but how many people have actually benefited? How much have all those collections contributed when measured against the outrage of the families concerned? How will the findings help those who have contracted these incurable diseases? In general, not just in relation to organ and tissue matters, does medicine pursue agendas that end up with a credit balance in medical gains versus any damage to individuals along the way or from side effects? A more pertinent question might be whether medical research should give more attention than it does to the origin of iatrogenic conditions, as there is evidence to correlate oral polio vaccine with the development of HIV/AIDS⁷ and the natural form of pituitary growth hormon...

Table of contents

• Cover
• Title Page
• Copyright Page
• Contents
• Preface
• About the author
• Dedication Page
• 1 Medical progress and human costs
• 2 What is good and ethical medicine?
• 3 The role of ethics in medical research
• 4 Law, medical research and the public
• 5 Non-compliance with the Human Tissue Act 1961 and its consequences
• 6 Misinterpreting the rules of post-mortem examination and the Human Tissue Act 1961
• 7 Ownership of and respect for the body
• 8 Natural law and medical research
• 9 Issues of public trust
• 10 Ethics and the practice of informed consent
• 11 The medical profession and the public
• 12 Empowering the public
• 13 Creating an ethical culture in medical research
• Postscript
• Index