Do human clinical trials go against human rights?

Clinical trials and testing has been an essential yet costly process needed when experimenting for new drugs and treatments. They cannot be used or sold to the public until extensive tests have been conducted, which include both pre-clinical and clinical trialling. This ensures the drug meets the efficacy, dosage and toxicity levels that are deemed acceptable and healthy for patients to use and this research is the path to finding out if a new drug or treatment is safe and effective. {1} However this does bring the volunteers involved in the clinical trials in the danger from certain risks, and the word “human experimentation” itself, still invokes a memory of the experiments carried out by the Nazis during the Second World War. Ethical guidelines placed since then have emphasised the importance of informed consent between the doctor and patient to ensure they are fully aware of the experimentations occurring and to protect the patient volunteers as well as the integrity of the research. {2} This essay will aim to discuss the past events of human clinical trialling where the rights of humans have been exploited, including the Syphilis Tuskegee experiment and the Nuremberg Trials. {3} 50 years ago, clinical trials were fully exploited with patients being stripped of their human rights but as mentality changed and stricter guidelines introduced, medical trials involving humans have become much safer and within medical ethics.

Before exploring the different cases where clinical trials have gone against medical ethics in the past, it is important to recognise and acknowledge the human rights associated with a patient or volunteer during a clinical trial and how it can be exploited or broken. The most important rights for the sake of this essay are Article 3, 5, 19 and 25, established by the UN. These articles are:

“everyone has the right to life, liberty and security of person”

“No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment”

“Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers”

“Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control”, respectively.

All the cases to be discussed in the essay go against at least one of these human rights and bring great discomfort and harm to the innocent patients involved.

There are four pillars of Medical Ethics:

  • Beneficence – doing good
  • Non-maleficence – to do no harm to the patient
  • Autonomy – final decision is always given to patient, when they are able to
  • Justice – ensuring fairness

These four pillars must be met somewhere during a medical practise or it can be deemed unethical and be terminated.

The Syphilis Tuskegee experiment in America was carried out from 1932 to 1972 and people who were suffering from the third or final stage of syphilis were most commonly picked out for this experiment. The third stage is the most dangerous and contagious stage of the syphilis where tumours form in the body of the patient and attack the cardiovascular system, Central Nervous system, bone structures and liver leading to life threatening damage. If the aorta is attacked and weakened blood may not get around the body as the blood pressure out of the heart will be reduced dramatically so cells and tissues all around the body are deprived of oxygen and glucose for their respiratory requirement leading to a slow and painful death.  The experiment undertaken by the United States Public Health Service during the 1930s involved almost exclusively black males, who, at the time, were among the poorest people in the world, and treated as slaves in a foreign country and only those who were already at the third stage of Syphilis.

The black patients involved as part of this experiment were treated like test subjects during the 40 year period, even though penicillin was discovered in 1928 and used widely by the time of the Second World War, the PHS of the United States refused to give the patients full treatment, but instead gave them just enough of an alternative medicine to keep them alive and non-infectious. This was to study the effects of third stage Syphilis in more detail but at the patient’s peril, as of the original 399 men involved in the experiment, only 74 survived. This experiment directly violates Article 3 and 25 as the patients are indirectly being killed by not being given the full and proper treatment and receiving inadequate and unsatisfactory living standards causing some of these deaths.

The Nuremberg Code was prepared at the end of the Second World War, as the Allied forces were aware of the crimes against humanity committed by the German Forces to prisoners of war and innocent civilians during the Holocaust. 6 million Jews were murdered during this time and many millions more a victim of German experimentation through concentration and death camps as well as laboratories. Nazi physicians and their assistants forced prisoners into participating; they did not willingly volunteer, and no consent was given for the procedures and this led to the Nuremberg Trials, where prominent members of the political, military, and economic leadership of the defeated Nazi Germany were prosecuted. The first and best known of these trials was the Trial of the Major War Criminals, which tried 22 of the most important captured leaders of Nazi Germany, though several key architects of the war (such as Adolf Hitler, Heinrich Himmler and Josef Goebbels) had committed suicide before the trials began. {9}

Combining the information from these trials and the 1931 Guidelines, {7} the Nuremberg Code was created and has served as a foundation for ethical clinical research since its publication 60 years ago and developed in response to the horrors of human experimentation done by Nazi physicians and investigators while focusing crucial attention on the fundamental rights of research participants and on the responsibilities of investigators. {5} A large emphasis of the Nuremberg Code was based off the information and communication between researcher and volunteer and that informed consent was a requirement and this directly corresponds to Article 19 with the right to impart and receive information. Without full and informed consent {8} the experiment should not go forward. The Nuremberg Code is one of the most important documents in the history of the ethics of medical research. {5}

Both the experimentation by the Nazis and the Syphilis Tuskegee go against all 4 pillars of Medical Ethics as no decisions were up to the patient and often lead to death – far from Beneficence and Non-maleficence.

However there is a lot of evidence to suggest that human clinical trialling that violates the human declaration of human rights and although the number of cases and severity of this is much lower than in the 21st century is nowhere the level of in the mid-1900s, they still exist. GlaxoSmithKline ran a series of human experiments between 2004 and 2012 involving both young infants and adults. GSK have sponsored at least four medical trials since 1995 using Hispanic and black children and were either infected with HIV or born to HIV positive mothers. {6}  All the children involved had no parents, or those that did, were deemed unfit to take care of the child – and this allowed the New York authorities to hold these roles. The experiment was designed to test certain HIV drugs, which usually have dangerous and sometimes life-threatening side effects. There was no consent between the child and the company and involved giving children as young as four a high-dosage cocktail of seven drugs at one time. {10}

In 2006 GSK were also accused of experimenting on soldiers with Hepatitis E vaccines, who were exploited and was deemed by the United States health government as unethical as soldiers could easily be coerced into taking part of drug trials due to their poor conditions. {12}  The fact that the breaking of medical ethics and human rights is still happening in the last 10 years leads to people arguing that human clinical trails are still against medical ethics and human rights as large companies sometimes do whatever it takes to reduce their cost of production to increase profits, and sadly this includes

On the other side, there has been a significant increase in government regulation in clinical trials. In the 1900s there was next to no intervention by the government against large firms from experimenting how they liked and due to this fact, led to the vast number of cases where patients have been exploited. In the 21st century there is a much stricter process of regulating clinical research leading to more ethical and healthy conditions for the patient.

The process includes an independent scientific review, which includes all the plans for the experiment, which is then reviewed by an external group of researchers. {13} An ethics committee then review the trial to ensure it meets the 4 pillars of Medical Ethics and that the benefits of the clinical trial outweigh the costs strongly. The large emphasis in recent years on informed consent and beneficence towards the patient has led to almost all clinical trials showing support to medical ethics and human rights.

There has been a huge shift from the start of large scale human clinical trials during the 1900s – these experiments carried out by the Nazis and on black people were incredibly unethical and broke almost all human rights in their nature and actions. Clinical research in the 21st century has improved massively in terms of safety to both patients and doctors, as well as in symmetric information between both parties, which is equally important. However it is undeniable that there are certain cases where medical ethics have been breached as the involvement and usage of incomprehensively researched drugs and treatments on people is bound to lead to certain complications and problems regarding safety as no one knows exactly what the response will be and this cannot always be avoided although the effect can be diminished.

In conclusion, to answer the question this essay has been developing, “do human clinical trials go against medical ethics and human rights?”, they certainly have in the past, and still do on rare occasions and is a very complicated issue when tackling due to asymmetric information between the two parties. But over the years through the regulation and increase in public knowledge has improved the safety and morality of these human experiments. Governments are actively hiring research teams to investigate clinical trials to ensure it is ethical, although it is difficult to monitor every firm or research team. It would be more efficient for the government to have enforce and delegate a specific team within a firm towards safety and ethics with a single focus.

This topic could be researched further if delved into further examples such as the Helsinki Declaration and the Belmont report which were also key turning points in the area of medical research and human experimentation. There have also been a lot of changes in government since they were first introduced with the Nuremberg Code after the second world war which could also have made for interesting extended research as certain changes led to loopholes and flaws in their fundamental system.

References:

  1. https://www.oatext.com/human-subjects-in-clinical-trials-ethical-considerations-and-concerns.php
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3894239/
  3. https://clinicalcenter.nih.gov/recruit/ethics.html
  4. The Oxford Textbook of Clinical Research Ethic

edited by Ezekiel J. Emanuel, Christine C. Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David D. Wendler oxford uni

  1. https://www.nejm.org/doi/full/10.1056/NEJM199711133372006
  2. https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(12)60217-7.pdf
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121268/
  4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2352998/
  5. http://www.eubios.info/EJ133/ej133g.htm
  6. https://www.theguardian.com/world/2004/apr/04/usa.highereducation
  7. https://www.nvic.org/FDA-Approves-Squalene-H5N1-Bird-Flu-Vaccine.aspx
  8. https://www.ft.com/content/93c488b6-a884-11da-aeeb-0000779e2340
  9. https://www.bma.org.uk/collective-voice/policy-and-research/ethics/clinical-trials

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Roshan Jeyakumar