Ethics of Placebo-Controlled Trials in Research: Understanding Placebos

The ethics of using placebo-controlled trials in researchWhat are placebos?The term placebo is often vague and there is no common definition. Many current explanations determine a placebo to be something that imitates real medicine however; it does not contain the active substance that has an effect to one's health. Placebos are prescribed with the aim of invoking psychological benefits to patients thus allowing a patient to feel physically better. Alternatively, placebos are used in experimentation of a newly developed drug to test its effects when given to users.

They often come in the form of pills, injections and sham surgeries. There are studies known as the double-blind and placebo-controlled which are commonly used in clinical trialling of new drugs. These studies give one group of patients the new drug being tested whilst another group is given an identical looking medication that does not contain the active substance that is supposedly giving health benefits. Neither groups of patients, nor the experimenters prescribing the drugs know who is receiving the treatment.

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This allows medical professionals to avoid bias and thus increase the reliability of the experiment's results.Undoubtedly, there have been a myriad of horror stories involving humans taking part in hideously unethical experimentation to contribute to advancements in science and our existing knowledge of the human form. Though by means of established human rights, safeguarding regulations and the creation of ethical committees (councils with the aim of safeguarding the ethics of these human trials) have meant that we have moved on from the era of dangerous, disempowering experimentation.

There are still ongoing debates pivotal to the medical profession involving the use of placebo-controlled trials, in particular in lower- or middle-income countries (LMIC). This will be the main focus of my essay.Why the use of placebos is considered unethical Although placebos are needed to prove the pharmacological effect of a drug and thus its effectiveness and safety, there have been ethical concerns in the past of their deceptive use on these patients as well as the standard of informed consent. There is often a very fine line between what researchers believe is an ethical use of placebos compared to an unethical use of placebos- many determine use of sugar pills or saline injections to be unethical however use of treatments that may work but are unlikely to can be seen as ethical.Creating deception through lack of Informed ConsentIn a clinical setting, placebos can be used as therapeutic treatments and a study funded by the Universities' of Oxford and Southampton showed that 77% of the 738 GPs who surveyed used at least one impure placebo a week. However, this violates the doctor's obligation to provide the highest standard of patient care for a number of reasons; the patient is unable to give full consent to the procedure, the patient is not fully informed about the side-effects, risks or benefits of the placebo and denies patients autonomy. There are still big concerns regarding the unethical, non-scientific use of placebos and the deceptive effect they have on the patient. It is believed that creating this deception is the only way to elicit the benefits of the treatment without actually giving the treatment. However in a clinical trial, this deception is shaped in a different, less obvious way; researchers have an obligation to inform the participant that there is a possibility in receiving a placebo during the trial but may often face the problem of making sure this information is understood.One of the central components of scientific research ethics is informed consent. When participating in a clinical trial a written consent form is now needed before the clinical trials can take place. The provided document would include the provision of all information about the study to the individual participating, this must include; the purpose of the trial, the risks, the alternative treatments, the research intervention and the benefits which can allow them to give consent to the trial prior to it starting. Researchers are also required to obtain a consent certificate, where the participant indicates clearly that they are voluntarily participating. Additional guidelines include the freedom to withdraw from the trial at any given time, signatures required from every piece of information given. The researchers and other members of staff are also obligated to have the correct Good Clinical Practise (GCP) as a requirement of the Uk Policy Framework for Health and Social Care Research, keep confidentiality of samples taken, check all information on the consent form; importantly the age of birth and ensure that good results are obtained from the data.There are some complications regarding the understanding of this information that can cause the trial to become unethical if not fully understood. Not only must researchers communicate this information effectively, it is more important that the participants can understand all this information which can be particularly hard in circumstances where the investigators may speak a different language meaning the consent documents have to be translated, participants are illiterate. Some people argued that consent forms are not clear enough, the amount of information is too large and the format it is set in may be confusing. The asymmetry of knowledge of the researcher and the participant can also be a problem; some scientific terms or concepts might be difficult to conceptualise so these terms need to be adequately explained and it can also be difficult to explain the randomisation of placebo-controlled trials. This lack of comprehension can lead to a misunderstanding known as therapeutic misconception' which is the belief that participation will create a medical benefit for the individual undergoing the trial. The power of therapeutic misconception is a problem if many of the patients believe that they are receiving the best form of treatment, the experimental treatment or no real treatment at all. The Ethics of using Placebo-Controlled Trials in Third World CountriesMore complicated ethical debates surround the use of placebo-controlled trials in third world countries such as sub-Saharan Africa, Asia. Competition to bring drugs into market is increasing, along with the intensified pressure on time and cost to bring a new drug onto the market. This has encouraged pharmaceutical companies to find ways to minimise the time take for drugs to be licensed. This is because in these developing countries, research can be done with less oversight enabling drug companies to gain approval to sell these drugs, realising profit as soon as possible.The Declaration of Helsinki and the problem it creates The declaration of Helsinki was first adopted in 1964 written by the World Medical Associations and is a document that has been developed for physicians and researchers as a statement of the ethical principles for medical research involving human subjects. Since it was first developed the Declaration of Helsinki has been revised 7 times with the most recent changes which took place in 2013, altering the structure of the document, eradicating sexist language and provided more detail in areas such as informed consent. However, it was the revision in 2000 which has sparked controversy and conflict amongst researchers, in particular clause 29 which states The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists'. The changes completely prohibit the use of placebo-controlled trials in all cases where proven treatment exists. Researchers found that this was impractical as testing new drugs against the best current treatment would increase the cost of research, while other people considered these oppositions could lead to the step back from the rights of the patient. This outcry resulted in a note of clarification written only a year later of this clause which provided extenuating circumstances where placebo controlled trials can be used, such as in cases where Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.'Although the new version was published to give more clarification on what is ethically acceptable, these extenuating circumstances are vague and it can be argued that they can still allow researchers to carry out the clinical trials as they please. The end of the paragraph states that as long as the patients who are taking placebos are not subject to any risk of serious or irreversible harm' placebo-controlled trials can be used. It implies that these risks must be truly severe in order to prevent these potentially dangerous trials from happening. In cases like this it is not easy to determine exactly where the line is drawn for what is considered serious or irreversible harm', consequently allowing researchers to determine this for themselves. Some may argue that this statement could even be interpreted as death. On one hand it can be argued that if there is treatment available that these people who come to the doctors for help should have their welfare brought to the fore, not scientific enquiry. They believe that this is in fact a step back in the rights of humans in research. Why was it controversial to use them?Worldwide attention has been focused on ethical concerns in international research, one of the questions that has been raised being if a particular study may not be conducted in the sponsoring country for ethical reasons, is it acceptable to carry out an identical study in a developing country, and, if so, to what justification?'. Marcia Angell, who frequently writes in professional journals about medical ethical issues such as this, argues that this creates a double standard. A double standard, according to the Cambridge English Dictionary is defined as a rule or standard of [] behaviour that, unfairly, some people are expected to follow or achieve but other people are not'. When the concept of a double standard is applied to the control group of women who received a placebo instead of the active treatment available, we can see that the two different groups are treated differently from each other when arguably they should be treated the same. If in any other trial the best current treatment would be used as the active group, it is then not ethically justifiable to argue that no treatment should be given because it is not the local standard care' in Uganda/ Sub-Saharan Africa. This also contradicts the joint guidelines for research in third world issued by the WHO and the council for international organizations of medical sciences, which require human subjects to receive protection at least equivalent to that of a sponsoring country.In addition to this, the spread of HIV in the developing world is rapid and even with available treatment is becoming an increasing larger problem. It could be argued that measures to make sure this rate of transmission was reduced should have taken priority over the outcome of the experiment. Further to this allowing the transmission of an anticipated, fatal health condition to new born babies, when it could be prevented, seems wholly immoral and indefensible.ConclusionThere is not a simple yes or no decision as to whether the use of placebo-controlled trials is ethically acceptable, but after research, I gained to ability to decide under which situations placebo-controlled trials are acceptable for use, and when they are not. Having been unsuccessful in finding alternative ways to truly prove the efficacy and safety of a drug or procedure through using active control groups, I believe placebos are vital in the clinical research trials in truly proving the efficacy of a drug. It is unrealistic to think there is a method of proving a drug has elicited a pharmacological effect for its intended use, if the nature of the placebo effect is not determined as well, hence why administrations such as the FDA have very strict regulations on their use. Circumstances where I believe placebos are completely morally acceptable to use in a control group, if the participants are not averse to serious, irreversible harm. It is argued that lack of comprehension of information can lead to lack of informed consent and eventually deception, deeming placebo-controlled trials unethical as this could potentially compromise the participant's rights and safety. I think stricter measures can be taken to overcome this issue of therapeutic misconception. Unlike in a clinical setting, researchers have a duty to inform the participants there is a possibility of receiving a placebo, therefore are ethically justifiable given measures have been taken to ensure the participant has fully understood the information. Although it could be considered unethical to withhold treatment from the participant which could provide therapeutic benefit, especially in cases where the disease is prevalent and potentially fatal, I believe it is in the best interest for the larger number of people to conduct these placebo-controlled trials, than not have them conducted at all because of the ethical implications inflicted on the participants. This allows the vast majority of people, including the participants, to have access to a treatment which has can bring therapeutic benefit. I do not, however, agree with some of the reasoning behind using placebo-controlled trials in third world countries. It is not right to deem the use of the placebo morally correct because nothing' is the standard treatment of the area, as the ethical principles in a LMIC should be parallel to one in a developed country, thus avoiding the creation of a double standard. Further to this, it is no secret that conducting trials in third world countries exploits the people taking part, as the findings are not particularly relevant to those participants who cannot afford the treatment being tested, researchers are targeting people living in LMIC's because it is significantly cheaper to conduct trials in these countries and research regulations may not be as strict. In conclusion, even if the participants will not have access to the treatment, ultimately, this is a better outcome than having no one benefitting from the treatment.