Course: SAT 170 Introductory Biotechnology

Unit 15 Learning Module

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Ethical Issues in Biotechnology
Ethics is an important part of all scientific research, but it is especially significant in the field of biotechnology where many of the topics and challenges that are encountered have never been encountered before. So what is ethics? Ethics is a set of principles, often referred to as moral values, which govern and guide our actions, especially our actions towards other individuals. Although ethics is considered a branch of philosophy, it can help us to make difficult decisions related to biological research and, thus, is an important component of biotechnology.

Clinical drug trials are an essential component to the development of new drug treatments.

Bioethics is a term used to specifically describe the ethics that applies to biological research, including biotechnological research. This is particularly important as much of the biotechnology research that we have discussed has direct impacts on humans and their environment, as was emphasized in previous units. While many of the researchers that are involved in advancing the field of biotechnology focus on whether or not or how something can be done, they must also consider the ethical questions related to their research such as should this be done? A key component to addressing all ethical dilemmas is to gather information and make thoughtful informed decisions based on that information.

To have a better understanding of how to approach ethical questions, we must review the common approaches to ethical decision making. Although we will focus on only two such approaches, realize that there are many others. This first viewpoint that we will discuss is attributed to the work of Jeremy Bentham and John Stuart over 100 years ago and is known as the utilitarian approach, which is also known as consequential ethics. The focus of this approach is on the consequences or outcomes of an action with the driving force behind decisions being trying to achieve the greatest good for the greatest number. Another aspect is that decisions should be made to create the least amount of harm and prevent the greatest amount of suffering. This approach not only considers the “good” and “harm” that can be done to other people but also to individuals of other species as they also have potential to thrive and suffer. In contrast to the utilitarian approach, the deontological approach focuses on decision making based on compliance with a rule or set of rules. This approach is also referred to as duty ethics as it assumes that an individual makes decisions based on a duty or obligation to adhering to such rules. Immanuel Kant is the individual who is responsible for developing this approach in the 1700’s.

Since the time of Bentham, Stuart and Kant, these approaches have undergone scrutiny and modifications. For example, in the 1970’s, modern bioethicist Joseph Fletcher elaborated on utilitarianism to encompass the idea that a decision is ethical if the ends justify the means. He also referred to this as situational ethics. The calculation for making a decision must weigh all of the possible answers to determine which would be able to provide the greatest positive effect. One of the major difficulties of such an approach is the subjectivity that a person employs when making a decision. Around the same time as Fletcher was working on his situational ethics, Ayn Rand was developing an approach known as objectivism which is considered an extension of the deontological approach. Objectivism emphasizes that there are certain absolutes which are independent of an individual’s hopes, fears or feelings and that these rules cannot be broken. One common tenant of objectivism is the idea that every man is an end himself and should not be considered to be as means to the ends of others.

As mentioned previously, when faced with an ethical decision one must collect information and base a decision on that information. This becomes incredibly problematic when facts are not available and one must speculate the outcome or impacts of such a decision. For example, it is clear to see that if you were to steal from another person, that person would no longer have what you have stolen from them. But when the consequences of an action are unprecedented, it is hard to weigh the information equally. For example, the release of a genetically modified insect into the wild could have impacts on biodiversity, but if it has not been done before, how can we consider this impact. This is where extensive thought and research comes into play with respect to scientific research. Often times, researchers must consider what is known as statistical probability. Statistical probability is used to estimate how likely something is to occur. In addition to determining how probable an event or outcome is to occur, researchers must also weigh how strong of an effect such an event or outcome may have. These considerations are part of a researchers risk assessment which is used to not only evaluate the likelihood of a particular event but also the potential loss that might be associated with such as event.

Often times when posed with a huge ethical dilemma, researchers will call for a moratorium until a full evaluation of the dilemma can be completed. A moratorium is also known as a suspension in activity; in this context it implies that all research in a particular field is halted until such research can be properly evaluated. An example of a moratorium that occurred in recent times is the 1975 conference in Asilomar, California which was organized to address the concerns associated with recombinant DNA technology. The outcome of this moratorium was that with certain regulations and controls, recombinant DNA technology could be performed in such a way that was deemed safe for humans and the environment.

Now that we have a better understanding of ethics, and the forces that help to drive our ethical decisions, we can talk more specifically about some of the ethically controversial topics in the field of biotechnology.

One of the things that we have focused on in this class is the use of recombinant DNA technology and cell cultures for the production of a variety of useful compounds including therapeutic drugs. This application of biotechnology requires that several factors are considered. For example, when developing a new drug, researchers must determine not only if a drug is safe but also whether or not it is effective. The safety of a drug is primarily focused on limiting any unwanted side effects. This includes very obvious reactions such as rashes and headaches but there can also be long-term effects that are much harder to measure. If a drug poses a carcinogenic or teratogenic effect it can have severe unintended consequences in the patient. A carcinogenic compound is one that causes cancer, while a teratogenic compound is one that causes birth defects. As we will discuss in more detail in our next unit, one of the steps of the drug approval process is to administer the drug to animals during what are known as preclinical trials. Ensuring human treatment of these animals is an important factor that must be weighed when deciding to take a drug to this stage of development. Once a drug has gone through preclinical trials, it may be eligible to test on humans during what are referred to as clinical trials. Once again, we face important ethical questions. Suppose you have developed a new anti-cancer drug and you are getting ready to administer this drug to patients selected for a clinical trial. How do you determine which patients should be a part of this trial? Do you select those that are last-stage cancer patients which have no other treatment options just in case the drug is determined to be ineffective or harmful? Or do you select patients that have early-stage diagnoses since they will benefit most highly? Part of this problem is solved by receiving what is known as informed consent. As it name implies, this is a form which a patient would sign after being informed of all of the possible beneficial and adverse outcomes of the treatment. Informed consent can help to relieve some of the ethical burden from the researchers by transferring it to the patients. Once you have received informed consent from patients to participate in clinical trials another problem emerges. Some of these patients will be placed in the experimental group where they will receive the drug while others will be placed in a control group which will receive a placebo. The placebo is a safe but non-effective treatment that is administered in the same manner as the treatment. For example, a sugar pill may be used to replace a drug that is ingested and a saline injection may be used to replace a drug that is injected. So how do you decide who is put in the experimental and control group of a clinical trial knowing that in some cases this drug treatment is a person’s last hope? A randomized double-blind trial is performed in an attempt to alleviate some of the ethical anguish over this decision. In a randomized double-blind study, the patients are randomly selected to participate in the experimental group and control/placebo group. Furthermore, neither the patient nor the individual administering the patient are informed of which group they have been placed in.