When a new drug is being developed, it has to go through several phases of clinical testing before it gets market approval
Introduction
When a new drug is being developed, it has to go through several phases of clinical testing before it gets market approval. This is a process that may take many years. However, it raises the question whether the experimental drugs may benefit the terminally ill patients who often set their hopes on experimental drugs but may not be able to wait since they might pass away before the drugs are available. Consequently, many terminally and seriously ill patients are often willing to participate in random controlled trials only as a way of getting experimental drugs. There are ways of gaining access to these drugs, including through compassionate use or expanded access programs where the terminally ill patients get the new drugs that are not yet approved for the market.
Relevant ethical theories and moral principles
In medical research ethics, two strands of thought often exist regarding the decision making process – deontology and utilitarianism (Raus, 2016). In the deontological approach, the outcomes of the decision may not justify the means of achieving it. In this case, the fact that the terminally ill patient may actually get healed does not justify giving them the experimental drugs that are not approved for the market. However, utilitarianism often justifies the means with the end. Based on the utilitarian line of thought, the patient has a moral right to the drug as long as it saves their lives, whether they are approved or not.
The most common justification for the compassionate administration of unapproved drugs is justice. The administration of unapproved drugs to the terminally ill is seen as a fair and just way of giving the drugs to individuals who have been denied access to them through no fault of their own (Raus, 2016). Giving them these drugs is also justified by the principle of beneficence that could claim that the terminally ill patients stand to benefit significantly with minimal risks, especially since they are already dying. In addition to this, there is the consideration of autonomy that gives the patient the right to exercise their independent decision making and having access to the drugs. This is seen as their free choice and that they are fully aware of the risks associated with the decision to access to the drugs.
The relevance of informed consent to the issue
Informed consent is one of the essential elements of research ethics. The basic ethical principle that informed the legalities of informed consent is the protection of the autonomy of the subject and to ensure that their interests and welfare of the individuals are always above those of society. Informed consent is founded on three essential elements of information disclosure, decision-making capacity, and voluntarism. Patients in the terminal phases of their illnesses are often too unwell to go through the entire process of information giving and consent (Spatz, Krumholz and Moulton, 2016). Nevertheless, randomized controlled trials continue to be the gold standard, and many people consider the studies to be more suited for palliative care. However, whatever the research approach or method undertaken in clinical trials, the consent of the patients should always be sought to ensure that their autonomy is protected.
The strong willingness of some patients to test the drugs often pose problems with regards to informed consent. Firstly, the offer may be seen as somewhat coercive, thus making it difficult for them to refuse. Consequently, this invalidates the principle of free and informed consent. Others argue that the principle of autonomy and consent might compromise the clinical trial system. For instance, according to Dawson (2015), many patients who volunteered for the AIDS trials lied to get into them and left the tests in large numbers, thus threatening the viability of the clinical trials system for AIDS.
Costs and benefits of making unproven, unapproved experimental drugs
One of the disadvantages of taking the experimental drugs is that the drug company may charge any amount for the drug under legislations. Consequently, families may go bankrupt as they try desperately for drugs that may have no chance of working. In addition to that, there is always the question of safety of the drugs. The drugs may be too toxic for human consumption. With no approval for their use, there may arise several legal litigations in case of any mishap.
Perhaps the most significant benefit of the unproven and unapproved experimental drugs is that any individual who is involved plays a role in adding to the knowledge of the reaction of the drug. The information gathered from these tests may be helpful for future patients. However, in cases of “the right to try” pharmaceutical companies are often under no obligation to report the experiences of the patients with the drug. Besides, the FDA has no knowledge of the individuals taking them.
According to Immanuel Kant, morality is often concerned with one’s duty to obey the unconditional and moral laws. His argument of the categorical imperative of morality established that any morally right action is usually based on duty and not considerations for the consequences (Ebunoluwa and Kareem, 2016). Therefore, Kant states that humanity should be treated as an end, not a means to an end. This argument by Immanuel Kant underscores the fact that patients with no other treatment options have a moral right to unproven drugs. This is because the maxims of the intended actions are right. The trials intend to ensure that one gets well despite the consequences. As such, the patient is only considered from the perspective of the end and not the means to the end. The morality of the process is also justified through the moral ethics of utilitarianism that justifies an action as long as it brings happiness, Mandal, Ponnambath, and Parija, 2016). Happiness, in this case, is the patient’s satisfaction that they did what they could to save their lives.
In conclusion, the ethics of clinical trials often forms a fundamental foundation in medical research. The right to try is often underscored when administering experimental drugs to terminally ill patients. In most cases they try the drugs to save their lives. This is a process that is justified by the principles of justice, beneficence, and autonomy. Autonomy also justifies their right to informed consent. Administering the unapproved drugs is also justified by the moral theories of utilitarianism and deontology, both of which consider the end and the means respectively.