Bioethics And The Biomedical Engineer

The last five decades have seen significant development in medical and biomedical technology and applications. The increase in research and development in fields such as biomechanics, biomaterials, cloning, tissue engineering, and medicine have spawned a whole new branch of philosophy aptly named bioethics. Bioethics, the study of the ethical and moral implications of biological research and biomedical advances, emerged in the early 1970s as its own discipline. As medical technology is improved and new developments made the influence of bioethics will place an ever increasing role on the research of scientists and engineers. It is extremely important that biomedical engineers on the frontline of cutting edge research be aware of the ethical dilemmas involved in their experimentation.

This paper has three objectives. The first is to briefly outline the development of bioethics as a field since the end of World War II. The second is a focus on the recent controversy seen with silicone breast implants where a lack of ethical measures in proper testing has caused harm to thousands of patients. Specific studies will be analyzed to determine the engineering aspects involved with testing and using the products and where a lack of ethics came into the process. Finally, this paper will discuss the responsibilities of the biomedical engineer to learn and practice bioethics in research and testing of new technology.

The horrible experiments of the Third Reich during World War II serve as one of the most shocking examples of a lack of ethical research. During the war doctors in Nazi Germany conducted horrifying research from limb transplants to hypothermia tests on prisoners in their concentration camps. The lack of ethics in these experiments has far reaching implications within the world of biotechnology. During the Nuremburg Trials of 1948 new measures in medical research were developed because of the atrocities. The most important to our research was the idea of “informed consent” for all patients in research experiments.

Nazi Germany was not the only location of unethical research in the mid 1900s. Many trials and experiments were taking place in America and Great Britain that have been revealed as dangerous and unethical. One example is the Tuskegee Syphilis Study conducted on 400 African American men. This study was conducted by the United States Public Health Service and went on from 1932 to 1970. The study followed the long term effects of syphilis. In 1950 when penicillin was proven to be effective at treating syphilis the subjects were not allowed treatment because the experiment was not finished. Approximately one hundred of the men died from complications due to their syphilis when a cure had been on the market for over ten years.

Other experiments during this time included studies of malaria, influenza, and dysentery. In the United States psychotic patients at the Illinois State Hospital were infected with malaria to be used as test subjects to discover a cure. President Franklin Roosevelt’s Office of Scientific Research and Development used orphans and mentally retarded individuals to find a vaccine for dysentery. The subjects developed dangerously high fevers with a few dying from the complications proving that the vaccine was ineffective. These and other experiments like them lead to the development of the Helsinki Declaration. This document was accepted by the World Medical Association in 1964 as a guide to human experimentation throughout the world.

In 1974 Congress passed the National Research Act which created the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. This commission produced the Belmont report which lay out a cohesive code of guidelines for conducting research. Despite new regulations disasters and tragedies still occur in the research and development of new methods and technologies in medical advancements. One tragedy occurred on September 17, 1999 when 18 year old Jesse Gelsinger died while participating in a gene transfer experiment to treat ornithine transcarbamylase deficiency at the Institute for Gene Therapy at the University of Pennsylvania. The Gelsinger family sued because of a lack of information prior to the experiment. The courts found that vital information about the gene delivery system was not released to the family or Jesse. This information included the death of two monkeys in animal experimentation and liver toxicity in other human patients.

One area of biotechnology that receives significant scrutiny from bioethicists is in the development of biomaterials. Researchers working to develop biocompatible materials for use as implants into the body must constantly be on watch for the ethical pitfalls in their experimentation. One of the most difficult issues for engineers working on producing biomaterials is the long term effect of a material implanted in the body. In order to properly test a material the researcher must understand the effects of the stress and wear the material will receive in the body. Consequently it is almost impossible to judge the effects thirty years down the road of implanting a prosthetic.

One of the most publicly controversial issues in biomaterials has centered on silicone gel breast implants (SGBI). In 1992 the United States Food and Drug Administration took SGBIs off the market for public availability. After thirty years of popular use it was determined that the SGBIs could be connected to a variety of problems ranging from the emission of carcinogens in the body to the increased potential for developing connective-tissue diseases. The modern SGBI began its evolution during World War II when many Japanese women used silicone shots to enhance their breasts. The first implantable breast prosthesis was developed by Thomas Cronin and Frank Gerow with the Dow Corning Corporation in 1961.

SGBIs serve two general uses and its important to note that silicone implants are used in other parts of the body. With this in mind 80% of SGBIs are used in breast augmentation and only 20% in reconstructive surgery. By 1992 it was estimated that approximately 2 million women in the United States had received silicone implants. The most popular SGBIs prior to the 1992 ban were actually 85 to 95% silicone fluid. A very small amount of this is true chemically crosslinked silicone gel. It has been well established that the diffusion of silicone gel into and through the elastomer shell occurs in many breast implant patients. The current question centers on the relative health risks of the bleed of silicone particles into the body. A side argument against the use of SGBIs is that the likelihood of local complications is much higher when the patient has a silicone implant than a saline implant.

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