Describe the social utility method for the allocation of scarce organs

11 Ethical and Bioethical Issues in Medicine

Learning Objectives

After completing this chapter, you will be able to:

· 1. Define the key terms.

· 2. List and discuss at least 10 bioethical issues the modern physician and healthcare professional face.

· 3. Describe how an ethical decision-making model, such as the Seven-Step Decision Model, can be used when confronted with difficult ethical dilemmas.

· 4. Discuss ethical issues relating to genetic testing.

· 5. Describe the advances in human stem cell research.

· 6. Summarize the ethical issues of organ transplantation.

· 7. Discuss the importance of codes of ethics such as the Nuremberg Code.

Key Terms

Alleges

Censure

Chromosomes

Clone

Control group

Double-blind test

Euthanasia

Expulsion

Gene markers

Gene therapy

Harvested

Human genome

Human Genome Project

Institutional Review Board (IRB)

National Organ Transplant Law of 1984

Nontherapeutic research

Placebo group

Posthumous

Revocation

Social utility method of allocation

Stem cells

Therapeutic research

United Network for Organ Sharing (UNOS)

THE CASE OF THE TUSKEGEE SYPHILIS RESEARCH STUDY

In 1929, the United States Health Service worked with state and local departments of health in six states to find a method to control venereal disease. The statistical reports that were conducted between 1930 and 1932 demonstrated a high rate of syphilis in Macon County, Alabama, where over 84 percent of the population were black and 40 percent of the men were infected with syphilis. The methods used for treating this disease consisted of the injection of mercury and other toxic chemicals. Some men recovered with this treatment; others were made even more ill; and in some cases in which no treatment was given, the patient was able to live for several decades.

After funding to treat the disease ran out during the Depression, the researchers conducting the Tuskegee Study attempted to discover how severe this disease was if left untreated. For this study, the U.S. Public Health Service selected 600 men. Of these 600 research subjects, 400 of the men had syphilis and the other 200 nonsyphilitic men became the control group of research subjects who received no treatment. The infected patients were not told about the purpose or nature of the research. In fact, the researchers would refer to procedures such as spinal taps as “treatments” to induce patient participation. When some of the men in the control group developed syphilis over the course of the study, they were transferred into the research group without ever being told they had the disease. No treatment was ever given to any of the men to fight the disease.

In the early 1940s, penicillin was found to be effective against syphilis. The Tuskegee Project could have been discontinued at this time, as there was no longer any need to study the course of this disease without treatment. However, the research project did continue. The researchers were able to track the men and make sure they did not receive antibiotics for any condition including syphilis. In the 1960s, a researcher working for the U.S. Public Health Service tried to put an end to the project, which was now being conducted by the Centers for Disease Control (CDC) in Atlanta. When he was unsuccessful, he notified the press and ultimately the project was stopped. The public was outraged that poor black men had been subjected to a research project without their consent and denied treatment for a treatable disease in an attempt to gain what was seen as useless information. In 1973, the surviving patients received an out-of-court settlement of $37,500 for the infected men and $16,000 for the men in the control group. The families of men who had died also received compensation of $15,000 for the infected men and $5,000 for the uninfected men.

In 1997, President Clinton offered a public apology to the men, including one 100-year-old survivor, who were involved in this study. The last remaining survivor of this study died in 2004.

This was never a secret project. This project had been well publicized in medical journals. The people who read about the study did nothing to stop it.

Source: Summarized from G. Pence. Classic Cases in Medical Ethics. New York: McGraw Hill, 1990.

Introduction

Healthcare ethics, bioethics, and medical law are intertwined out of necessity. When ethical principles are violated, a civil lawsuit often follows. As we have explained throughout this book, ethics, that branch of philosophy relating to morals or moral principles, involves the examination of human character and conduct, the distinction between right and wrong, and a person’s moral duty and obligations to the community.

Ethics, as discussed in the healthcare professions, is applied ethics. In other words, while theoretical concepts involving ethics are important for the student to know, the basis for study involves applying one’s moral and value system to a career in healthcare.

Ethics involves more than just common sense, which is an approach for making decisions that most people in society use. Ethics goes way beyond common sense: It requires a critical-thinking approach that examines important considerations such as fairness for all consumers, the impact of the decision on society, and the future implications of the decision.

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The dignity of the individual, whether it is the patient, employee, or physician, must always be of paramount concern when discussing ethics and bioethics.

Bioethics concerns ethical issues discussed in the context of advanced medical technology. The somewhat new field of bioethics requires the healthcare professional to ask whether a practice such as gene therapy or cloning can be morally justified. In addition, physicians must ask themselves if these practices are compatible with the character traits of a good physician.

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Remember that, as discussed in Chapter 1 , an illegal act, or one that is against the law, is almost always unethical. However, an unethical act may not be illegal. For instance, providing medical treatment, such as an organ transplant, to a celebrity and denying the same treatment for an indigent “street person,” while legal, is clearly unethical.

EARLY HISTORY

Ethics has been a part of the medical profession since the beginning of medical practice. In 400 b.c., Hippocrates, a Greek physician referred to as “the father of medicine,” wrote a statement of principles for his medical students to follow that is still important in medicine (see Figure 11.1 ). Called the Hippocratic Oath, the code reminds students of the importance of their profession, the need to teach others, and the obligation to never knowingly harm a patient or divulge a confidence. The principles stated in the oath are found today in many of the professional codes of ethics, such as that of the American Medical Association (AMA). The Hippocratic Oath is found in Appendix A .

Figure 11.1 Hippocrates

(Brian Warling/International Museum of Surgical Science, Chicago, IL.)

ETHICAL STANDARDS AND BEHAVIOR

Ethical behavior, according to the AMA, refers to moral principles or practices, the customs of the medical profession, and matters of medical policy. Unethical behavior would be any action that does not follow these ethical standards. For example, it is unethical for physicians to decline to accept patients due to their race or color.

A physician who is accused of unethical behavior or conduct in violation of these standards can be issued a warning or censure (criticism) by the AMA. The AMA Board of Examiners may recommend the expulsion (being forced out) or suspension of a physician from membership in the medical association. Expulsion is a severe penalty because it limits the physician’s ability to practice medicine. Even if the AMA censors its members, it does not have authority to bring legal action against the physician for unethical behavior. However, not all physicians belong to the AMA.

If someone alleges , or declares without proof, that a physician has committed a criminal act, the AMA is required to report it to the state licensing board or governmental agency. Violation of the law, followed by a conviction for the crime, may result in a fine, imprisonment, or revocation (taking away) of the physician’s license.

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The loss of a physician’s license, as required by law in serious cases of fraud, will usually mean the loss of the physician’s reputation.

CODES OF ETHICS

People’s behavior must match their set of values. For example, it is not enough to believe that patient confidentiality is important if one then freely discusses a patient’s personal information with a coworker or friend. In this case, the healthcare professional’s values and behavior are at odds. Professional organizations have developed codes of ethics that summarize the basic principles and behavior that are expected of all practitioners in that discipline. These codes, also known as statements of intent, are meant to govern the conduct of members of a given profession, such as medicine.

Some codes of ethics were developed as a direct response to atrocities that occurred during wartime, especially in response to the medical experimentation in Nazi concentration camps during World War II (WWII). Public awareness of the ethical and legal problems associated with medical research, such as experimenting on human subjects, gained prominence in the post–WWII trials at Nuremberg, Germany. In these trials, more than 25 Nazi medical personnel were accused of committing war crimes against involuntary human subjects. The most infamous experimenter, Josef Mengele, was also known as the “angel of death.” What became known as the Nuremberg Code developed after these trials made public what the Nazis had done under the guise of medical research. This code became a forerunner for the subsequent codes and guidelines that were adopted by medical and research organizations and agencies. The Nuremberg Code reminds us that basic ethical principles must be followed when conducting medical research, or any research involving human beings. The Nuremberg Code is found in Appendix A .

Due to advances in medical science and technology, and changes in the medical profession, physicians have developed modern codes of ethics that serve as a moral guide for healthcare professionals. The AMA has taken a leadership role in setting standards for the ethical behavior of physicians in the United States. The first Code of Ethics of the AMA was formed in 1847, shortly after the organization was founded.

American Medical Association (AMA) Principles of Medical Ethics

The AMA Principles of Medical Ethics—which appear in Chapter 5 —discuss human dignity, honesty, responsibility to society, confidentiality, the need for continued study, patient autonomy, a responsibility of the physician to improve the community, a responsibility to the patient, and access to medical care.

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Every healthcare professional who interacts with patients, such as medical receptionists, medical assistants, nurses, physician assistants, and pharmacy technicians must be familiar with the Principles of the AMA. For example, just as physicians cannot refuse to treat patients based on race or color, neither can their staff. Their behavior can reflect either negatively or positively on their employer/physician.

Judicial Council Opinions of the AMA

The Council on Ethical and Judicial Affairs of the AMA is comprised of nine members who interpret the Principles of Medical Ethics. The council’s interpretation or clarification is then published for AMA members. All members of the medical team are expected to cooperate with the physician in upholding these principles. A few of the opinions of the Council on Ethical and Judicial Affairs are adapted and summarized in Table 11.1 .

TABLE 11.1 Summary of Opinions of the Council on Ethical and Judicial Affairs of the AMA

Issue

Opinion

Abuse

Physicians who are likely to detect abuse in the course of their work have an obligation to familiarize themselves with protocols for diagnosing and treating abuse and with community resources for battered women, children, and elderly persons. If it were not reported, it might mean further abuse or even death for the victim.

Accepting patients

A physician may decline to accept a patient if the medical condition of the patient is not within the area of the physician’s expertise and practice. However, a physician may not decline a patient due to race, color, religion, national origin, or any other basis for discrimination.

Allocations of health resources

Physicians have a duty to do what they can for the benefit of the individual patient. Physicians have a responsibility to participate and to contribute their professional expertise in order to safeguard the interests of patients in decisions made at the societal level regarding the allocation or rationing of health resources. The treating physician must remain a patient advocate and, therefore, should not make allocation decisions.

Confidential care of minors

Physicians who treat minors have an ethical duty to promote the autonomy of minor patients by involving them in the medical decision-making process to a degree equal with their abilities.

Euthanasia

Euthanasia is the administration of a lethal agent by another person to cause the patient’s death and thereby relieve the patient’s suffering. Instead of engaging in euthanasia, physicians must aggressively respond to the needs of patients at the end of life. Patients should not be abandoned once it is determined that a cure is impossible.

Fee splitting

The practice of a physician accepting payment from another physician for the referral of a patient is known as fee splitting and is considered unethical.

Financial incentives for organ donation

The voluntary donation of organs in appropriate circumstances is to be encouraged. However, it is not ethical to participate in a procedure to enable a donor to receive payment, other than for the reimbursement of expenses necessarily incurred in connection with the removal of any of the donor’s nonrenewable organs. In addition, when death of the donor has occurred, it must be decided by a physician other than the donor patient’s physician.

Gene therapy

The Council’s position is that gene therapy, the replacement of a defective or malfunctioning gene, is acceptable as long as it is used for therapeutic purposes and not for altering human traits.

Ghost surgery

A surgeon cannot substitute another surgeon to perform a procedure without the consent of the patient.

HIV testing

Physicians should ensure that HIV testing is conducted in a way that respects patient autonomy and assures patient confidentiality as much as possible.

Mandatory parental consent to abortion

Physicians should ascertain the law in their state on parental involvement in abortion to ensure that their procedures are consistent with their legal obligations.

Physician-assisted suicide

Instead of assisting patients in committing suicide, physicians must aggressively respond to the patient at the end of life.

Quality of life

In making decisions for the treatment of seriously disabled newborns or of other persons who are severely disabled by injury or illness, the primary consideration should be what is best for the individual patient and not the avoidance of a burden to the family or to society.

Withholding or withdrawing life-prolonging treatment

Patients must be able to make decisions concerning their lives. Physicians are committed to saving lives and relieving suffering. When these two objectives are in conflict, the wishes of the patient must be given preference.

Source: Adapted from the American Medical Association, Code of Medical Ethics © 2008—2009 .

CODES OF ETHICS FOR OTHER MEDICAL PROFESSIONALS

Other professional organizations have developed codes of ethics that assist in guiding members’ behavior. These organizations promote practicing their profession with honesty, integrity, and accountability. They are committed to respecting all laws, and avoiding involvement in any false, fraudulent, or deceptive activity. Two such groups of professionals include nurses and medical assistants.

Nurses’ Code of Ethics

The American Nurses Association (ANA) has developed a code for nurses that discusses their obligation to protect patients’ privacy, respect patients’ dignity, maintain competence in nursing, and assume responsibility and accountability for individual nursing judgments. This code is found in Appendix A .

Code of Ethics of the American Association of Medical Assistants (AAMA)

Medical assistants may not be faced with the life-and-death ethical decisions that face the physician, but they will encounter many dilemmas regarding right and wrong on an almost daily basis. For example, how does the medical assistant handle a situation in which another employee violates confidentiality or uses foul language in front of a patient? How is a homeless patient treated whose body smells of urine and alcohol? What do we do if we make an error? What do we do if we observe a coworker making an error? These are issues involving ethics and doing the right thing at the right time. To provide guidance for this category of allied health professional, the AAMA has developed a Code of Ethics for Medical Assistants. This code is found in Appendix A .

Other professional organizations, including the American Dietetic Association, the American Health Information Management Association, the American Society for Medical Technology, and the American Society of Radiologic Technologists, have developed codes of ethics.

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Know the code of ethics that relates to your professional practice. Many healthcare professionals keep a framed copy near their place of work to remind them of this responsibility.

BIOETHICAL ISSUES

Bioethical issues, resulting from advances in medical technology, are reported in newspapers and journals almost daily. Debates about cloning, harvesting embryos, and in-vitro fertilization were unknown two or three decades ago.

As we read in the Tuskegee case, there was very little protection for the men involved in the study. Unfortunately, there are examples of poor protection for the individual today. As recently as 2001, two students at two major universities died in government-sponsored clinical trials. Another concern is that ill or dying patients will rush into any treatment or research trial to try and save their life.

There is a real concern that expensive biotech treatments will be used for chronic illness when a more reasonably priced product is available. Patients may not be able to afford the co-pay or their out-of-pocket share. An ethical dilemma arises when the patient is no longer able to afford the treatment and the insurance company refuses to pay. The patient with a chronic disease may decide that “enough is enough” and decide not to take medication.

The privacy issue is a major concern when dealing with technological advancements. For example, scientists are now able to decode our genetic composition through the human genome project. But this also means that information about a person’s future health, such as a five-year-old child’s future tendency for serious heart disease, may become available to others, including insurance companies. The question arises about to whom our health information should be made available.

Stem cell research has become an important topic among religious and even political groups. Some states are taking initiatives to promote the development of stem cell research to fight diseases such as Parkinson’s disease. In California, voters examined the potential economic value of stem cell research, and, based on that criterion, passed Proposition 71, which guarantees the spending of $3 billion in state funding over the next decade.

And finally, many scientists and politicians have examined the potential loss of lives in the case of a terrorist attack. The federal government is promoting Project Bioshield to promote the development of vaccines and preventive medications in quantities that can protect a large number of people. Economists and ethicists are concerned that the amount of money spent on these items will leave less for diseases that are becoming more prevalent. On the other hand, there is an optimistic approach that the research and development of this project could lead to finding medicines to treat diseases. And, in addition, this research may lead to fighting infections such as those caused by HIV and hepatitis.

Table 11.2 illustrates a wide variety of medical issues relating to bioethics.

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Adherence to bioethical principles involves the entire healthcare team, not just the physician.

TABLE 11.2 Medical Issues Relating to Bioethics

Abortion

Allocation of scarce health resources

Cloning

Determination of death

Euthanasia: active and passive

Fetal tissue research

Genetic counseling

Harvesting of embryos

HIV, AIDS, and ARC

In-vitro fertilization

Organ donation and transplantation

Quality-of-life issues

Random clinical trials

Stem cell research

Sterilization

Surrogate parenthood

Withdrawing treatment

Withholding lifesaving treatment

Organ and Tissue Donation

In the United States, people may voluntarily donate their organs and tissues to others. They can indicate their desire to do this in their advance directives or, in some states, on their driver’s license. The most commonly donated organs and tissues are eyes (usually the cornea), heart, kidneys, skin, bone marrow, blood, liver, and lungs. In addition, the long bones of the body (tibia, fibula, femur, humerus, radius, and ulna) can also be transplanted. There are some organs and tissues, such as blood, bone marrow, and kidneys that can be donated by living persons. There is a law in the United States that prohibits the sale of organs. The only payment allowed is to cover the medical costs for the donor of the transplant.

Many more people need donor organs than in the past because dialysis and other medical advances are able to keep them alive longer as they wait for transplants. The United Network for Organ Sharing (UNOS) system, established in 1999, contains a database relating to every organ donation and transplant event occurring in the United States since 1986. UNOS is the legal entity in the United States responsible for allocating organs for transplant. They use a formula that gives half the weight to considerations of medical utility or need, and the other half to considerations of justice. Current estimates of people waiting for a transplant in the United States are estimated as high as 400,000. There are more than 106,000 people listed on the UNOS waiting list, and many of these people will die before they can receive a donor organ. Most of the needed organs are for kidneys.

Due to a severe shortage of donor organs, patients have resorted to going onto the Internet to search for a donor, and have even used ads, public broadcasts, and even billboards to advertise their need. Unfortunately, in some cases transplant departments have exaggerated the severity of their patient’s condition in order to have him or her jump ahead on the UNOS list. UNOS has recently made changes in its allocation system to prevent this type of abuse. From an ethical perspective, the transplant surgeon still may have to make the life-or-death decision about who receives the first available organ ( Figure 11.2 ).

The Ethics of Transplant Rationing

One of the most discussed bioethical issues today is who shall receive an organ transplant. The issue of organ transplantation adds a strong ethics component to medical ethics. These procedures are some of the most expensive of all medical procedures. Liver transplants cost about $250,000. In addition, the follow-up care to aid the transplant by suppressing the immune system can be more than $30,000 a year.

Figure 11.2 Patient Undergoing Hemodialysis while Waiting for a Kidney Transplant

The criteria for rationing of transplants are controversial. The problem began back in the 1960s when kidney dialysis machines and centers were scarce. The centers had to establish screening committees to determine who should be allowed to have kidney dialysis. At a Seattle, Washington, dialysis center, a screening committee was composed of a lawyer, a physician, a housewife, a businessman, a minister, a labor leader, and a state government official that became known as the “God squad.” One of the lay members of this committee recalled voting against a woman who was a known prostitute and a playboy ne’er-do-well. An observer to this process claimed that committee members were measuring patients according to their own middle-class, suburban standards.

Many believe that there is an element of “playing God” with the moral issues of removing human body parts from one person and placing them into another person’s body. In many, if not most, cases, the donors are still alive when the discussions are held concerning the harvesting of their organs, adding another dilemma. Usually both a healthy donor and ill recipient do well after surgery. However, there are some exceptions. A 57-year-old man in New York donated a part of his liver to his 54-year-old brother. In this case, the recipient did well after surgery, but the donor unexpectedly died from surgical complications.

In some countries, it is legal to remove organs from a deceased person unless the person has made an objection. For example, in one small village in Pakistan there are many poor people who have long purple scars on their side resulting from surgery to sell a kidney, often for less than $1,700. However, the United States and Great Britain are among the countries still committed to the donation model for organs. Under the donation model, organs may be taken ( harvested ) only with the consent of the donor (or the donor’s surrogate representative). The Uniform Anatomical Gift Act, which has been adopted in all states, permits competent adults to either allow or forbid the posthumous (after death) use of their organs through some type of written document, including a donor card. See Figure 11.3 for a sample donor card.

Problems still arise over the allocation of scarce organs. Many ethicists and others believe that because there is a fixed supply of transplant organs, especially livers and hearts, clearly defined standards should be used by all transplant committees. One basis for determining the allocation of organs is to give them to patients who will benefit the most. This is the social utility method of allocation . It is based on careful screening and matching of the donor with the recipient to determine if there is a strong chance of the recipient’s survival. Another favored approach is one of justice, which gives everyone an equal chance at the available organs. A controversial proposal would put younger patients higher on the waiting list.

Figure 11.3 Organ Donor Card

Other methods used to allocate scarce transplant organs include a seniority (first-come, first-served) basis and a lottery method. Both of these methods cause concern because they may result in providing a scarce resource, such as a heart, to a patient whose need is not as great as a patient further down the seniority list. The lottery method may result in a patient with little chance for recovery, such as someone suffering from terminal cancer, receiving a scarce organ. When other criteria for selection are added, such as age, social status, or ability to give back something to the community, there is the suspicion that this is not a just system for all persons.

A combination approach using basic “medical suitability,” which measures the medical need and medical benefit to the individual patient, may be used first. After a decision is reached, then a seniority (first-come, first-served) basis is the most often used method.

Most people agree that selling organs is morally objectionable. The National Organ Transplant Law of 1984 forbids the sale of organs in interstate commerce. This law seeks to protect the poor from being exploited, as they may be tempted to earn money by selling what they believe to be an unneeded organ, such as a kidney. There is also a concern addressed by this legislation that the donor organs should be located as close to the patient’s locale as possible in order for a fast response when an organ becomes available.

There have even been suggestions that there should be a financial incentive for cadaver (a dead body used for dissection and study) organs. However, ethicists and members of the general public are against this proposal. They are very concerned that a “slippery slope” could develop by hastening the death of a person to harvest the organs.

Medicare has been expanded to fully fund kidney transplants, and most insurance plans will now fund heart transplants. A number of courts have questioned or even reversed decisions by Medicaid to not fund liver transplants. In a Michigan case, the court required the state to fund a liver transplant for an alcoholic patient. The court found in favor of the patient in spite of documentation that the patient’s alcoholism most likely resulted in the need for the transplant (Allen v. Mansour, 681 F. Supp. 1232, E.D. Mich. 1986). See the case study on Mantle’s new liver later in the chapter.

A dramatic example of the painful decisions surrounding the issue of organ transplants is the situation that the state of Oregon faced in the 1980s. The state could either fund Medicaid coverage for 1,500 additional patients or continue to fund its organ transplant program for an anticipated 34 patients. Between 1985 and 1987, the state funded 19 transplants at a cost of $1 million, only nine of these patients survived the transplant. Cost estimates for transplants in Oregon for the years 1987 to 1989 were $2.2 million. Because the amount was expected to double during the next two years, voters in Oregon believed that it was more cost effective to fund Medicaid, which provides basic healthcare for many, rather than fund transplants for the few patients who would require them. The public response to this new plan was slow. However, there was a nationwide response when a seven-year-old boy died without receiving a needed bone marrow transplant to treat leukemia. The new law resulted in several lawsuits as well as fund-raising for transplants in Oregon. The lessons learned from Oregon’s plight are many:

· 1. Medical resources are limited in all states.

· 2. The need for acute care, such as for transplants, is more visible than preventive care, such as prenatal care.

· 3. New medical discoveries and treatments, with their enormous costs, are likely targets for cost containment rather than older, more basic, medical treatments.

· 4. For new treatments to be funded, they must replace older, ineffective treatments.

These difficult issues mean that policymakers will have to examine all treatments on a cost/benefits basis and be ready to eliminate outdated and ineffective medical treatments. Information about organ transplants is found in Table 11.3 .

TABLE 11.3 Information about Organ Transplants

· The largest group of Americans awaiting organ transplants are those ages 50 to 64.

· More than 28,000 transplants were performed in 2009.

· People of all ages can be tissue and organ donors.

· The heart is the only organ that cannot come from a live donor.

· Organ donation does not conflict with the tenants of any major religion.

· A person can register to be an organ donor at most state motor vehicle bureaus.

· Even if a person is a registered donor, family members ultimately decide whether their relative’s organs may be donated after death.

· It is essential that everyone who wishes to donate their organs clarifies their wishes to family and friends.

ETHICAL ISSUES AND PERSONAL CHOICE

In some cases, the healthcare professional may have a personal, religious, or ethical reason for not wishing to be involved in a particular procedure. Ideally, this preference should be stated before one is hired. If a situation arises after an employee is hired, it should be discussed openly with the employer. The employee can request permission to refrain from participating in a procedure, such as a therapeutic abortion, if that procedure would violate the employee’s values or religious beliefs. However, in some situations, the inability of an employee to assist the physician may jeopardize the health and safety of the patient. In these cases, it may even be necessary for the employee to resign.

There are still many areas of medical ethics for which there are no conclusive answers. When should life support be withdrawn? Is euthanasia (intentionally killing the terminally ill) ever permissible? Should a baby’s life be sacrificed to save the life of the mother? Should a baby be conceived in order to donate a needed organ to an ill or dying sibling? Scientific discoveries continue to present new medical possibilities and choices—but with these possibilities come more complicated ethical issues that must be addressed before choices can be made.

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The ethical implications of these issues and dilemmas must be carefully examined by the healthcare professional. The ethics of the employer must be in agreement with the ethics of the healthcare professional.

THE ETHICS OF BIOMEDICAL RESEARCH

Ethics of the Biomedical Researcher

The relief of pain and suffering, the restoration of body functions and health, and the prevention of disability and death are all aims of healthcare. Human experimentation is considered necessary for medical progress to occur. Both animal testing and human testing have been used successfully to further medical knowledge and conquer disease.

Medical research almost always carries with it some degree of risk. Human beings cannot be used for testing purposes unless they consent to participate. Obtaining informed consent is particularly important in nontherapeutic research , or research that will not directly benefit the research subjects. The justification for all medical research is that the benefits must outweigh the risks. Many consider that this utilitarian, or benefit/cost, approach to decision-making is a good model to use when examining medical research. Merely increasing knowledge is not considered an adequate justification for taking a risk with a human life. Medical researchers must abide by the standards for testing that have been established by their medical associations, such as the AMA and the ANA.

The Department of Health and Human Services (HHS) implements government standards for research. The government requires that all institutions that receive federal research funds, such as hospitals and universities, establish an Institutional Review Board (IRB) that oversees any human research in that facility.

Consent

Informed consent (as discussed in Chapter 5 ) is necessary when a patient is involved in therapeutic research. Therapeutic research is a form of medical research that may directly benefit the research subject. The research subject must be made aware of all the risks involved with the research. In addition, the subject must be informed about the type of research design that is used. These consist of:

· Control group who receive no treatment;

· Randomized study in which the subject is assigned at random to either the control or experimental treatment group (who receive treatment);

· Or a placebo group in which an inactive substance or an alternative type of treatment is given.

The physician conducting the research must explain all the facts relating to the research, even if this means that the patient may decide not to participate.

An African-American woman, Henrietta Lacks, unknowingly gave an incredible gift to research when a strain of cancer cells was saved from a tumor that was removed from her in 1951. Mrs. Lacks died a few months later from a virulent strain of cervical cancer. The tumor was sent to a researcher at Johns Hopkins where he was trying to find cells that would live indefinitely so that researchers could experiment on them. Mrs. Lacks’ cancer cells were perfect as they multiplied rapidly and did not die in the lab. A cell line from these cells, called HeLa (named after Henrietta Lacks), has become immortal and is still used by researchers. This cell line was used to develop the first polio vaccine, and helped produce drugs for numerous diseases including Parkinson’s, leukemia, and the flu. Millions and millions of these cells have been produced and are now sold to researchers, and have generated millions of dollars in profit. However, the Lacks family has never benefitted from them, and Henrietta Lacks died in poverty. Even though rules about informed consent have changed in the last 60 years, nevertheless, patients still do not have much control over tissues and organs that are removed during surgery.

There is a strong belief among most people that performing research without permission is unacceptable. And many Americans are reluctant to even give consent for medical research. In 1996, the Department of Health and Human Services and the Food and Drug Administration (FDA) passed regulations that allowed research about emergency treatment to occur without first having received permission. In some cases, such as with an unconscious patient or one whose condition does not allow time for informed consent, it was necessary to perform research in order to help learn how to care for patients with life-threatening injuries.

Clinical Trials

Clinical trials are organized medical studies to provide large amounts of clinical data used to evaluate medical treatments. The studies are funded by drug companies, medical device manufacturers, and the government to test new treatments on volunteers. The overall objective is to determine if the product is safe and effective to use on patients. The treatments must be approved by an independent safety panel, with the oversight of the FDA, or the Office for Human Protections. All of the research subjects must be fully informed of any potential ill-effects or hazards.

Many patients who participated in clinical trials have received benefit for illnesses such as stroke, multiple sclerosis (MS), and cancer. However, in some cases not all clinical trials have a positive outcome.

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Some medical ethicists have concluded that, in some cases, the risk to human life is too great in clinical trials.

When Research Can Resolve Debate over the Best Treatment

Medical research does not always give the answers that the medical profession is looking for. Ethics becomes a concern when the results prove that the type of treatment subjects have been receiving has actually harmed them. And in some cases, there is no definitive answer on the best treatment. For example, in the case of prostate cancer, men have been faced with the decision of having their cancerous prostate removed with the inherent danger of suffering from impotence and incontinence or leaving this slow-growing cancer alone. The latest research indicates that after six years there is little difference in the death rate between the men who had the cancer removed and the men who did not. However, the overall death rate from cancer by the end of their life is 50 percent lower in the men who had their prostate removed. A urologist at Johns Hopkins, Dr. Patrick Walsh, believes that death from this type of cancer should be prevented since the cancer moves into the bones and can be extremely painful. But the experts are still divided on the best treatment to use.

A research study with a happy ending is the case of premature baby, Jake Hoyt. The infant was born four months ahead of schedule weighing 1 pound, 10 ounces and was hospitalized for 102 days. On his eleventh day after birth he experienced one of the most frequent causes of death in premature infants when his intestines tore and failed. (This happens in as many as 10,000 of the 500,000 premature infants born every year.) There were two options for treating Jake. One choice was to insert a drain into the ruptured or torn part of the intestine. The other option was to perform surgery and remove the damaged portion of the intestine. Because Jake’s condition was frail, he was given the drainage tube to pull out the waste products from his intestine rather than to put him through a surgical procedure requiring a general anesthetic.

His doctor made that decision, in part, based on the results of a pediatric research study at the Yale-New Haven Children’s Hospital, in which it was determined that the outcome was the same whether the patient was treated with the surgery or the drainage tube. Until the research study took place, doctors were determining which treatment to use based on their own preference. During a four-year research period, when a baby was rushed into the operating room at a hospital participating in the study, the doctor was handed one of two randomly selected sealed envelopes. Half of these envelopes gave instructions to insert the drain. The other half had instructions to perform the surgical procedure to remove the dead length of tissue. Because the results of the study showed no significant difference in the outcome of the two procedures, many doctors are performing the tubal insertion such as Jake received, rather than the surgical option. The surgical treatment often placed an additional burden on an ill infant. In this type of research study, all the infants received beneficial treatment.

Jake’s mother stated that she is grateful that he received only the tubal procedure because his feeding and aftercare were much easier. He went home, with a functioning intestine, nine days before his due date weighing 5 pounds, 7 ounces. Doctors state that they no longer have to consider the tubal procedure as a “second-class” treatment ( Figure 11.4 ).

Figure 11.4 Premature Infant

© allOver images/Alamy

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The physician is responsible for explaining to the patient all the risks involved in a research project. However, other healthcare professionals, such as nurses, pharmacists, and medical assistants, may become aware of information relating to a research project that needs to be conveyed to the attending physician. An example would be a patient who tells the nurse that he is taking a medication prescribed by another attending physician at the same time that he is taking an experimental drug from a medical researcher.

Conflicts of Interest

A conflict of interest can arise in medical research if the researcher’s interests are placed above the interests of the patient. For example, medical researchers fearful of losing financial backing for research projects may state incorrect data or test results in order to have the research appear more successful than it is. In addition, it is a conflict of interest if physicians engaged in drug-testing research for pharmaceutical companies own stock in those companies. In both examples, the physicians may be improperly placing their own interests before the patient’s interests.

Dr. Ezekiel Emanuel, who heads the Department of Clinical Bioethics at the National Institute of Health Clinical Center, believes that evidence shows that researchers who have a financial tie to manufacturers will tend to interpret their data in a more favorable light when they are studying those companies’ products. He recommends that the key to running important medical studies is to have people who can make independent judgments.

An unusual example of a conflict of interest occurred when a manufacturer of medical devices decided not to send a “Dear Doctor” letter of warning about defective equipment because it did not want to expose patients to “unnecessary device replacement.” The Guidant Corporation, which manufactures implantable heart defibrillators, determined that two of their models had an electrical flaw. In fact, at least seven patients are known to have died when their defibrillators failed to work. These defibrillators are life-saving devices that are surgically implanted into the patient and control potentially fatal heart rhythms. A “Dear Doctor” letter was drafted as an internal memorandum alerting medical doctors to these defects, but the letter was never sent. The company finally alerted doctors to the defect when it became aware that the New York Times was going to publish an article about the problem.

Ethics of Randomized Test Trials

Many ethicists believe that it is unethical to use a control group when conducting medical experiments, as this group has no hope of benefiting from the experimental drug. A race-based control group may produce an additional ethical dilemma. For example, in the Tuskegee syphilis case at the beginning of the chapter, the Public Health Service used members of the black population who had untreated syphilis as a research group. These patients were not given an effective treatment for syphilis that was available at the time. A race-based selection of research patients is unethical unless there is evidence that they will benefit by the therapy. There are some diseases that affect only a particular portion of the population, such as Tay-Sachs disease that affects the Jewish population. In this instance, research participants in a study to eradicate Tay-Sachs disease would be drawn only from the Jewish population.

Problems with the Double-Blind Test

In a double-blind test , neither the experimenter nor the patient knows who is getting the research treatment. This is considered to be an objective means of gathering test data because it eliminates any bias, or preference, the researcher may have toward a specific research method or treatment. An ethical question arises with double-blind tests about the process of informed consent. Are the patients fully aware that they may not be receiving any treatment whatsoever? In some research situations, where the physicians discover an immediate positive effect of an experimental drug on the test group, the project will be adjusted so that the control group can also receive the treatment.

HUMAN GENOME PROJECT

The Human Genome Project was begun in the early 1990s as a research program by the federal government. The purpose was to determine or “map” the sequence of the total number of genes, estimated at 100,000, each of us has within the 23 pairs of human chromosomes. This complete set of genes is known as the human genome . It resembles a set of blueprints for the human being that is stored in the nucleus of each cell.

The goal of the Human Genome Project, which is supported by scientists in several countries, is to provide a map of where each gene is located on the 23 pairs, or 46 chromosomes. The U.S. portion of the genome project was divided between scientists in nine centers at both national laboratories and universities. This important project was estimated to cost between $3 and $5 billion and take 15 to 20 years to complete. However, the project was completed ahead of time in the year 2003 and has provided important information for both biological and medical researchers.

The Human Genome Project provides a better understanding of the process of human evolution. The most important information for medical researchers relates to an improved understanding of the relationship between certain genes and particular diseases. The hope is that this genome information will result in the eventual elimination or control of genetic diseases such as cystic fibrosis and sickle-cell anemia. Ultimately, a test for a gene could actually diagnose a medical condition before any symptoms even appear. The “maps” that have been created by this project make it ten times quicker to locate a particular gene on a linkage map.

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A genome linkage map is similar to a roadmap in that it provides the location of where a particular gene (genetic material) is located on the chromosomes. Chromosomes are threadlike structures within the nucleus (center) of a cell that transmit genetic information.

There is currently an astonishing list of genes identified as gene markers that are responsible for disease. Some of these gene markers for disease are for colon cancer, amyotrophic lateral sclerosis (ALS), Type II (adult onset) diabetes, Alzheimer’s disease, Huntington’s disease, and achondroplastic dwarfism.

GENETIC ENGINEERING

The ability to alter the basic structure of life to correct a malfunction is the goal of genetic engineering. It has increased the prospect of curing genetic diseases and enhancing the genetic code of children. The new trait, as developed through genetic engineering, would then be passed along to succeeding generations. For example, it may be possible for scientists to develop a trait that would prevent the development of colon or breast cancer. This trait, if passed along to succeeding generations, could mean a more pain-free and longer life.

Cloning

Moral and ethical concerns are raised by critics who say that manipulating the human genetic code is “playing God.” One of the most controversial examples of genetic engineering is in the area of human cloning. A clone is a group of genetically identical cells that come from a single common cell. Thus, cloning makes an exact replication of a parent or a cell. In 1997, a sheep named Dolly was cloned by a Scottish scientist who found a new way to reproduce sheep by fusing the nucleus of a cell taken from the udder of a six-year-old sheep with the ovum from another sheep after the nucleus was removed. This resulted in the lamb’s receiving the chromosomes from only one parent (the female), not two. Dolly was then a clone, or twin, of her six-year-old mother. The birth of Dolly caught the public’s attention. There was widespread speculation about the ability for human cloning. Shortly after Dolly was cloned in February 1997, President Clinton banned the use of federal funds for research on cloning human beings.

Researchers claim that one major reason for developing cloning in animals is to permit the study of genetic development and genetic diseases. It has been claimed that studying cloning in humans might eventually enable infertile couples to have children that are genetically related to them. Further claims state that cloning also reduces the risk of passing along some diseases that are caused by defective genes, as only nondefective chromosomes would be used in the cloning process. There has been speculation that cloning could be used to create “spare parts” by growing stem cells for particular areas of the body. It is not yet clear if there would be major advantages to human cloning.

One of the strongest arguments against human cloning is the effect it might have on human dignity. There is a concern that if we are able to control the creation of human beings, then we might also have the ability to limit the creation of defective human beings. The definition of “defective” could have very different meanings depending upon who supplies the definition. For example, a child born with crossed eyes or a clubfoot might be considered to be “defective” even though these are relatively easy-to-repair disorders. There are three reasons that are most frequently given to oppose cloning:

· 1. Health risks from the mutation of genes

· 2. Emotional risks

· 3. The risk of abusing the technology

Several early attempts at cloning produced disfigured animals with many abnormalities. Additionally, there is a concern about the emotional pressure of knowing that a person is perhaps the twin of a long dead brother, or even the notion that a person’s sister is actually his or her mother. Finally, the abuse of this technology causes some people to equate cloning with a Hitler-like attempt to create only “perfect” human beings—in the case of Hitler, these would be members of the Aryan race.

The anti-abortion lobby promotes a ban on therapeutic cloning used for medical purposes, because four-days-old embryos are destroyed in the process. This group believes that this practice is the same as taking a life.

Gene Therapy

Gene therapy , in which a needed gene is spliced, or connected, onto the DNA of body cells to control the production of a particular substance, is still in its infancy. The opportunities are limitless. For example, diseases such as PKU, caused by the absence of a single enzyme that can cause cognitive impairment if untreated, might be corrected by altering a person’s genes to manufacture that enzyme. Many diseases involve dozens, or even hundreds, of genes and are more difficult to correct.

However, scientists are investigating many unanswered questions about gene therapy. The biotechnology companies, in particular, are expecting to earn millions with the development of their new medical techniques and products for gene therapy. But they are also raising troubling ethical and moral problems. Should gene therapy be used to create healthier fetuses? Should these companies develop tests to predict mental illness?

Fertility clinics are interested in testing their embryos for the newly discovered cancer gene, which would then allow parents to pick a child without that risk. Religious leaders have criticized scientists for patenting genes they discover, saying that no one can “own” genes.

Many people are concerned that gene therapy, performed to save lives, will eventually become gene enhancement to augment a desirable feature in our appearance or body function. For example, a wish for tall, blond children is an example of a misplaced use of gene therapy. Other ethical issues include whether it is right to provide a therapy to fight dwarfism, but not to let other children take it to add a few inches to their height. What about engineering hormones to turn average-sized children into basketball players? What are the implications for a society of people seven feet tall? Biotechnology’s societal implications are becoming more complex as scientific discoveries increase.

Human Stem Cell Research

Stem cells are considered the master cells in the body that can generate specialized cells. In 1998, Dr. James A. Thompson, a University of Wisconsin researcher, became the first person to isolate stem cells. These cells, which can grow into any cell or tissue in the body, are extracted from the inner mass of a developing embryo. They are composed of 100 to 300 cells that are small enough to fit on the head of a pin. Scientists regard these cells as the building blocks of a new era of regenerative medicine in which the body can eventually heal itself. According to scientists, the stem cells can be used to treat a variety of diseases, including Parkinson’s disease, Alzheimer’s disease, spinal cord injuries, stroke, and diabetes. For example, in the case of diabetes in which the pancreatic cells are ineffective, researchers can produce healthy pancreatic cells from embryonic stem cell lines that are then transplanted into a diabetic patient.

The controversy surrounding human stem cell research is not about the ability to end disease, as most people agree that this should be the purpose of medical research, but rather the use of frozen embryos to conduct the research. Cells are removed from frozen embryos, which are obtained in a variety of ways, including those that would be discarded by in-vitro fertilization clinics. Some of the embryos are grown in the laboratory especially for the purpose of stem cell research, some are obtained from terminated pregnancies, and a few are donated by couples who have excess embryos as a result of in-vitro fertilization.

This research has resulted in intense criticism from several fronts, including religious groups and abortion opponents, because the embryos used in the research are destroyed. These groups believe that the embryo is a living human being, and destroying them is therefore the same as killing a person. The issue is so controversial that Congress has banned all federal financing for stem cell research. However, this ban does not affect private stem cell research. In addition, the FDA, which oversees research therapy tested on people, presently has little jurisdiction over embryonic research.

Many states have widely opposing views on the research. For instance, a Massachusetts law enacted in 1974 prohibits using any live human fetus in experiments. On the other hand, Pennsylvania has introduced legislation to allow government-financed scientists to derive stem cells from embryos. A representative from South Dakota, Jay Duenwald, who introduced legislation to ban stem cell research, likened it to Nazi experiments. His legislation passed, and embryonic stem cell research is now a crime in South Dakota, punishable by as much as a year in jail and a $1,000 fine.

Many state spokespersons are not opposed to studies using frozen embryos to treat diseases like diabetes, but they fear what they consider negative uses, such as for cloning. President George W. Bush restricted federally funded research to stem cells that already had been obtained before August 9, 2001, but no new embryonic cells could be harvested after that date. While the ability to use stem cells that had been obtained before the August 2001 date still remains true, the ban on research has been lifted by President Obama’s administration in 2009. While federal funding is now available for stem cell research, it is unclear about the amount that will actually be provided as research funding is limited.

One answer to the moral dilemma created by stem cell research is a new procedure that would not destroy embryos. In this method only one cell is removed from the embryo without destroying the embryo. This cell would be allowed to divide into two cells. One of these cells would then be tested for genetic defects and the other cell would be cultured to propagate new stem cells. If genetic defects were found in the first tested cell, then the cells would be discarded. Some ethicists have voiced a concern that removing even one cell might damage the embryo.

A more noncontroversial approach to stem cell research is offered by the researchers who use sources other than embryos. For example, blood stem cells can regenerate specialized cells to treat blood disorders such as leukemia. These blood stem cells are found in adult bone marrow, in umbilical cord blood, and in small amounts in the circulating blood stream. The hope is that these stem cells can be used in new ways to produce other types of cells such as neural and liver cells. This is far less controversial than embryonic stem cell use.

A “slippery slope” is often mentioned during a discussion of stem cell research. The use of the term “slippery slope” is meant to warn people that there are dangers associated with starting a practice that is ethically questionable. We can easily slip backward down that slope and find that the uses for stem cells may be outweighed by the ethical dangers of harvesting them.

Whistleblowing

Whistleblowing occurs when employees publicly report a potentially dangerous situation in their organization to authorities who can take corrective action. The employee must

· 1. Exhaust all other channels for correcting the situation within the organization.

· 2. Have documented evidence that would convince an impartial and reasonable observer.

· 3. Have good reason to believe that by “blowing the whistle” and going public the necessary changes will be made to prevent harm and injury.

The ethical justification for whistleblowing is evident as it is a service to protect others. This is often done at great personal risk to the whistleblower. Often whistleblowers are subject to harsh treatment by others within their organization, even coworkers. Before a decision is made to “go public” with information, it is wise to consider all other alternatives. An anonymous complaint can be made to a regulatory agency such as the Environmental Protection Agency (EPA). The Occupational Safety and Health Act (OSHA) of 1970 prohibits any retaliation against an employee who files a complaint with OSHA. The Solid Waste Disposal Act and the Food and Drug Administration also protect employees against retaliation for “blowing the whistle.” Whistleblowers who work for the federal government are protected by law from losing their jobs. As a last resort some people have leaked information to the press such as in the Guidant case mentioned previously.

Even though the lives of many whistleblowers have been negatively affected, most say that they could not have lived with themselves if they had remained silent.

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Whistleblowing is always used as a last resort when all other methods for warning about a dangerous situation have failed.

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Medical office personnel must treat all patients with the same consideration for the patient’s dignity no matter what their ability to pay.

Another problem that has driven up the cost of medical care is that physicians have encountered the need to practice a form of defensive medicine to avoid potential lawsuits. The estimate is that at least $100 billion of the United States $1.7 trillion annual healthcare bill is the cost of defensive medicine including cesarean deliveries, unneeded antibiotic therapy, and advanced imaging tests such as PET, MRI, and CT scans. In some cases, patients request these imaging procedures for aches, sprains, and cardiac assessment. As a result, some insurance companies have issued policy statements declaring that full body scans are medically unnecessary.

It is understandable that when unexpected situations occur, such as flu pandemics, it is necessary to ration healthcare services due to limited medications and vaccines, service providers, and treatments. For example, during a recent H1N1 flu outbreak there was a question about “who gets the vaccine in a flu outbreak?” Physicians argued that young people, rather than the elderly, should have limited vaccines first. Most people agreed with this decision.

However, many Americans are concerned that they are not receiving necessary healthcare on a daily basis due to rationing. There are arguments about whether women under 50 years of age should receive mammograms. There is ongoing debate about elderly patients having expensive procedures such as MRIs and CT scans. Many believe that a renewed interest in correcting inequalities in the healthcare system will solve some of these questions and problems.

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