No other field of medicine offers as many confusing, often contradictory opinions of what is and what is not legal and ethical.

Plastic Surgery
The first written record of reconstructive plastic surgery was found around 2600 years ago in Sanskrit texts of ancient India. Repair of cleft lips was performed as early as the fourth century in China, and repair of the cleft palate was first performed successfully in France in the 18th century. Still it wasn’t until after World War I that plastic surgery became a respected field of medicine.

In the latter part of the 20th century elective plastic surgery—known as cosmetic surgery—became more common, and more popular. Now it is even being requested for adolescents and children, which creates unique ethical difficulties.

The rights of parent to make choices for a child have also entered into another controversial medical procedure, the Cochlear Implant.

The Cochlear Implant
The cochlear implant is a device made up of several electrodes that is surgically implanted in the cochlea, then connected to a transmitter coil that is placed under the skin and held in place by a magnet. The device has an earpiece microphone with two wires extending from it that are connected to the coil, and to a signal-processing component that can be worn in a pocket, or attached to a belt. It was first approved by the FDA for use in adults in 1985, and in children in 1990. At first only people with profound deafness were eligible, but over the years the technology has continued to evolve and now the eligibility criteria have greatly expanded. Today, children as young as 12-months can be considered for an implant and adults who are classified as “hard of hearing” can also be helped by the implant in certain cases.

The implant works differently than a hearing aid, which simply amplifies sounds. It creates electric signals that are sent to the brain by the auditory nerve. The brain recognizes the signal as sound. This signal requires “interpretation” so training and speech therapy are necessary to maximize the benefit of the device.

Proponents of the implant believe this is a major step forward in enabling the hearingimpaired to lead more “normal” lives, but there is strong opposition based on both medical and moral grounds. Opponents argue that the implant implies that being deaf makes a person inferior, that deafness is a negative medical condition that should be cured.

The moral questions are wide and varied, but the most ethically challenging is, “What’s wrong with being deaf?”

To those in the hearing world, that may seem a ridiculous question. To never hear music, or birds singing, or another human voice seems cruel. But can one miss something one has never had? By trying to “fix” a child who is non-hearing in order to make her/him more able to function in a hearing world, is the child being consigned to a sort of limbo, neither belonging to the hearing community or the non-hearing community?

Most recipients of the cochlear implant in the United States are children, which creates a quagmire of ethical questions.

In cases like these, a physician might be forced to choose between the role of advisor to the parent or advocate for the child. The final decision can only be reached when considered within the framework of how it will make one feel about her/himself.

Organ Transplants
The first organ transplant was performed in Boston in 1954 when a kidney was successfully transplanted from one identical twin to another. In 1963 the first lung transplant and the first liver transplant were performed.

For the most part, the community at large had a positive reaction to organ transplants, until 1967 when Dr. Christian Barnard of South Africa performed the first successfull heart transplant. Many people around the world were horrified at the notion of a heart being removed from a dead person and put into someone else. There was a tremendous public outcry against the procedure. It was labeled unnatural. It was considered desecration of the dead. In the extreme Dr. Barnard was even referred to as another Dr. Frankenstein. Opponents posed some difficult questions. What if the person wasn’t really dead when the heart was removed? Would doctors and nurses still try to save a patient whose heart could be used as a transplant?

Forty years later, heart transplants have become fairly common, as are other organ transplantations including the pancreas. Many patients receive more than one organ at a time. Recently there has been a great deal of success transplanting sections of a lung or liver from a living parent into a child. The fears that were raised have mostly proved to have been hysterical reactions to new technology.

For the most part, the medical aspects of transplanting organs from one human being to another have become accepted practice, and legislation has been passed to help provide safeguards against abuse.

Of course, there is a persistent “urban legend” surrounding organ transplantations that refuses to die, perhaps because other technological marvels, like the internet and e-mail, work so hard at keeping it alive. An E-mail chain letter surfaces every few months to warn of the horrors of travel, because one might wake up sitting in a bathtub full of ice minus a kidney.

Among the ethical difficulties concerning transplants are two that are very basic. The first is in determining how an organ will be obtained. In the United States and many other countries there are laws in place that specifically make it illegal to buy or sell human organs. In addition, the practice is strongly opposed by the World Health Organization and most other international medical bodies.

The second difficulty is determining who gets an available organ, and that is less black and white. Although there are laws and guidelines in place, there have been instances when a person has been moved up on the wait list for reasons other than medical. A well-known example occurred when a middle-aged Hall of Fame baseball player was moved ahead of everyone else on a wait list for liver transplant, even though he had a long history of alcoholism which at the time made him ineligible for the transplant. Only two months later he died.

The wait list can sometimes be circumvented by what is known as “Medical Tourism.” This is the growing practice of traveling outside the United States for transplants and other surgical procedures, such as plastic surgery. This is a fairly new phenomenon and no specific laws or peer standards have been universally accepted as of the publication of this program. In fact, some facilities in the United States are considering opening branches in countries with more favorable pricing structures to enable patients to receive procedures they would not be able to afford in this country.

Tissue Transplants
Tissue transplants began in 1869 when a Swiss surgeon performed a skin graft using donated skin. In 1906 the first corneal transplant was successfully performed. As advances in medical science and technology have rapidly advanced, so have the options for tissue transplants, which now include bone, tendons, ligaments and heart valves. Estimates are that there are more than one million people in the United States alone who have had a tissue transplant.

Another arena for ethical issues in transplantation has risen from a highly controversial area of research, xenografting - the transfer or transplantation of animal tissues and/or organs into a human body. The transplantation of certain cells from animals to humans has garnered some success, for example in the treatment of Parkinson’s Disease. Again, the ethical question of “What is natural?” surrounds an area of medical advancement. Is it unnatural to implant an organ from a lower species into a human being? Does transplanting an animal organ, or animal tissue, violate certain religious ethics? Is the religious ethic the only one that has moral authority? Is the person still human, or has she/he become a chimera?

Among animal rights activists there has been a general hue and cry that this is the greatest form of animal cruelty yet devised by humankind. What right does humankind have to kill other animals and cut their hearts out? Is human life the only life that has value?

As genetic research advances the genetic makeup of lower species, pigs for example, will be able to be altered to make their organs acceptable to the human body. Is using genetic manipulation to create animal organs that are more conducive to transplantation into humans violating the natural order of the universe? Are other species being subverted entirely for human survival?

Genetic manipulation leads to another dominant topic in modern medical ethics - the Human Genome Project.

The Human Genome Project
The Human Genome Project was completed on April 14, 2003, which was also the 50th anniversary of the discovery of the double helix structure of DNA. This was two years ahead of schedule, and $300 million under the original budget of $3 billion. The announcement was made by the National Human Genome Research Institute (NHGRI), the Department of Energy (DOE) and their partners in the International Human Genome Sequencing Consortium. They also announced that all of the sequence data generated by the Human Genome Project has been deposited into public databases and has been made available to scientists around the world without restraint. So far this information has not produced significant practical applications, but eventually it will, and that will create a wealth of ethical issues.

Huntington’s disease is a devastating, incurable hereditary neurological disorder. Genetic testing can determine whether or not an individual has the potential to develop the disease, or pass it on to her/his children. This testing can be done presymptomatically for people at risk of the disease, and prenatally to determine whether or not a fetus is at risk of the disease. The test cannot determine when a person will develop the disease. Normal onset is between 35 and 50 years of age, but can begin earlier or later. Right now there is no cure for Huntington’s, nor is there successful universal treatment.

Consider amyotrophic lateral sclerosis (ALS), another catastrophic nuerological disease for which there is no cure and no treatment. If gene testing had been available two generations ago, the sports world might have been deprived of baseball legend Lou Gehrig, for whom the disease is now named. The world of science might have lost the brilliance of Stephen Hawking.

In this age of ever advancing technology, will there possibly be a cure someday, or will those who carry the ALS gene simply not reproduce and therefore stop the search for a cure, leaving those who develop ALS spontaneously to suffer and die with no hope?

Even if developing a dread disease with an adult onset is inevitable, who is to say that a short life is not worth living? Mozart died in his 30s, yet he was one of the most brilliant and prolific composers in the western world. Did he not merit being given life?

Designer Babies
As genetic testing of embryos has become more sophisticated, the term “Designer Babies” has crept into our vocabulary—and means exactly what it says. There have been several controversial cases of parents who want to give birth to another child in order to provide a tissue-matched donor for an already living child with a terminal illness. This is done by testing embryos created through in vitro fertilization and only implanting the embryos that are a tissue match for the living child, or by testing a fetus and if the fetus is not a match, aborting it so the mother can become pregnant with an embryo that will match.

Is it ethical to only give life to a child if she/he can save the life of an existing child? On the other hand should a sick or dying child not be helped if the science exists to provide medical help? Again, this is an area in which there is ongoing legal debate and very few clear-cut legal answers, so the ethics are something the physician must struggle with on a personal level.

What about genetic testing to determine eye or hair color? Will parents want to order a child like they do a new car? Will physicians be faced with a laundry list that says, “blue eyes, blonde hair, tall, athletic, brilliant?” What happens if during pregnancy something goes wrong and the child doesn’t meet the parents’ standards? Do they get a refund? Is the child put up for adoption? If prenatal tests show that there is a perfectly healthy but unfortunately red haired child in the womb, will it be aborted? How much control should medicine ethically and morally exercise over human reproduction? Are human beings who are less than perfect less valuable? Who determines the standard of acceptability - the physician, the parents, the government?

The area of medicine that has made the prenatal manipulation of genes a future probability—reproductive medicine—is another that is rife with conflict and ethical pitfalls.

Reproductive Medicine
One of the most respected physicians of the twentieth century, Albert Schweitzer, winner of the Nobel Peace Prize, once wrote:

Dr. Schweitzer wrote those words in a magazine article in 1936. Now, more than 70 years later, the ethical question of “...even which particular individuals, we shall save...” is only one life and death decision a physician must now grapple with. There is also the question of who should be born?

The birth control pill was only the beginning of the impact modern medicine has made on human reproduction. Artificial insemination and in vitro fertilization have become so much in demand that treating infertility has become a medical specialty. A specialty full of potential ethical pitfalls.

With the rise of artificial insemination came the unfortunate rise of several sperm banks and specialists who have made headlines for their unethical and illegal actions. One physician was using his own sperm to impregnate women who thought they were selecting a donor from a sperm bank, or being impregnated by sperm from their husbands. This physician not only lied to his patients, he also created the potential for possibly incestuous relationships among persons who were unknowingly half-siblings. This was a morally heinous act, and the physician lost his license and was imprisoned.

Another clear-cut ethical violation was committed by a practice specializing in in vitro fertilization. In this case, fertilized embryos were being implanted in the womb of a woman who was not the egg donor, without her knowledge. Several children were born to parents not their own. Once this became public knowledge it created untold emotional pain for the families involved. Not only for the “birth parents” who discovered that their child was not truly theirs, but for the “genetic parents” who had biological children in the care of total strangers.

DNA testing can answer the biological question of who is biologically related to whom, but the emotional and legal quagmire this situation created will take years to clear up. Should the children be returned to their biological parents? Should the biological parents be forced to contribute to the support of these children?

Embryonic Stem Cell Research
Possible breakthroughs in the treatment of a wide range of diseases through the use of cell therapy hold a great deal of promise. Currently laws in the United States limit research involving adult stem cells, umbilical stem cells and a limited number of embryonic stem cell lines. When these lines are exhausted, there will be no more federally funded embryonic stem cell research here, and that has caused a great deal of debate everywhere in the country. Many medical experts believe that cell therapy will provide the most important medical advances since antibiotics. One-third of the people in the United States and about two billion of the people in other countries suffer from diseases that may eventually be cured thanks to stem cell research, including heart disease, diabetes, and certain types of cancer—and the greatest potential for cell therapy success lies with embryonic stem cells.

At present the debate in the United States does not revolve around creating embryos to use for stem cell research, which would be considered at best unethical under most existing codes, but the use of existing “excess” embryos created for in vitro fertilization. Right now there are two options for those embryos:

1) Make them available to other childless couples.

2) Destroy them.

Many parents do not want to donate their embryos to other couples—in fact, only a very small minority choose this option. That leaves destroying them. This is also a very difficult choice to make, which is why current estimates are that as many as 400,000 frozen embryos are in storage in the United States right now.

Even when the legal debate is resolved, for physicians the ethical question of how to advise patients will remain. Physicians will always find themselves in situations in which they must rely on their own personal ethical and moral standards in making decisions. That same requirement exists in another outgrowth of advancing technology—determining who shall die.

Life and Death Decisions
At the end of the 19th century it was very easy to define death. When someone stopped breathing and the heart stopped beating death had occurred. At the end of the 20th century, it was not so simple. Technology made it possible to keep a human being alive, at least in the technical sense, almost indefinitely. Therefore it was incumbent upon the medical field and society in general to come up with a new definition of death. In the United States this was accomplished in 1978 by passage of the Uniform Brain Death Act, which basically established that for legal purposes, when brain death occurs a person is dead. Unfortunately, defining when death occurs only addresses the tip of the iceberg. Far more complex quandaries lie below the surface.

Life Support
In common parlance, the decision of when to “pull the plug” on life support equipment has been the subject of much legal and ethical debate. Many hospitals now require that each patient being admitted for even minor surgical procedures must complete a living will. This document requires that the patient or the patient’s legal guardian make the choice before surgery of whether or not extraordinary measures will be taken to prolong life, and at what point these measures will be stopped. Legally this protects a physician, but again the line between what is legal and what is ethical blurs.

Perhaps not. As medical technology has advanced most patients expect miracles, not problems. Short of creating true terror by describing everything that could possibly go wrong - and pointing out the number of patients who do suffer harm because of medical mishaps - can a physician or other health care professional be sure that the patient really wants no extraordinary measures? Again, a tough question. Should the family routinely be consulted about life support decisions even if a living will has been signed? What if there is no family?

In many emergency departments life support equipment is routinely used until a determination can be made whether or not a person can be saved. At that point it is up to the chief emergency room physician to make the call. The same is often true in intensive care situations - the decision is made by the physician in charge. If continued efforts will prove futile, none are made. Although the term “futile,” which is defined as “meaningless, without any hope of a useful result,” is now discussed by the medical profession on a regular basis, it too is subject to interpretation.

Sometimes a patient’s request to stop life support will be at odds with the physical criteria, and with the physician’s point of view. For example, a patient who is mentally aware but must rely totally on life support and feeding tubes for her/his existence may request that life support be stopped, which will mean death. There are legal guidelines for dealing with this “right to die” issue, but what about the ethical question? Does the physician have the right to force another human being to live connected to electronic devices? A human being who is totally dependent and for whom only the most innate human dignity is still possible?

A very famous life support legal case involved a father who wanted the feeding tube that was keeping his daughter alive removed. The young woman had been the victim of an automobile accident and although not brain dead, had no hope of recovery or return to even a semblance of independent life. This became a cause celebre for both right to die and right to life political forces. Pro life proponents pointed out that the woman still made sounds, and still made movement. Right to die supporters countered with the argument that these were simply reflexes totally void of cognitive awareness. This case dragged on for years, and went all the way to the Supreme Court. In the end, the father was given custody of his daughter. Her feeding tube was removed and she died shortly thereafter.

Assisted Suicide
Probably the most hotly debated topic in the national arena of life and death decisions is physician-assisted suicide. Two events that took place in the 1990’s demonstrate the widely diverse public view of this subject.

In 1997 the State of Oregon passed the Death with Dignity Act, which legalizes physician-assisted suicide, but with very strict parameters. (see Appendix D.)

In 1999 the State of Michigan imprisoned Dr. Jack Kevorkian, well-known advocate of assisted suicide, for second degree murder.

Dr. Kevorkian assisted in a suicide, videotaped it and sent it to a national network news program which aired the videotape. He also challenged the Michigan courts to arrest him for the videotaped suicide. The courts accepted the challenge. He was sentenced to 10-25 years in prison. He was denied parole in December, 2005 and will not be eligible again until 2007.

The Death with Dignity Act faced numerous legal challenges, the last one from the United States Justice Department. By the summer of 2003 all legal objections had been overcome and the law remained in full force. In the first five full years the law was in force from 1998 through 2002, assisted suicides accounted for less than one-tenth of 1% of all Oregon deaths. Through Spring of 2006 the rate has remained constant at about 20 physician assisted suicide deaths per 10,000 total deaths each year.

Assisted suicide will continue to be a source of controversy and ethical concern. If legalized physician-assisted suicide becomes more widespread and accepted, must a physician working in a public health facility assist in suicide even if it violates her/his own personal or religious ethics? These and other difficult questions remain on the horizon.

Perhaps the most emotionally charged field in which life support decisions must be made is that of neonatal intensive care. Thanks to technology, extremely premature infants can now be kept alive. Babies weighing less than two-and-one-half pounds who were given almost no chance of living in the recent past are now routinely surviving. Many of them are born with complex medical problems. The questions that must be answered in this situation are deeply complex.

Yet another ethical consideration rears its ugly head here, “At what financial cost?”

Economic Considerations
In the best of all possible worlds financial cost would never be a consideration in medical treatment. But this is the real world, and economics is increasingly a factor with which all physicians and health care providers grapple on a daily basis.

Care of the elderly is another area that generates a great deal of concern regarding health care costs. In 2004 the CDC estimated that more than one-third of all health care costs in the US were spent by persons over 65, and that 28% of annual Medicare expenditures were spent on the last year of a person’s life. This has given rise to public debate about whether or not expensive life-saving measures should be taken for an elderly person who probably won’t live more than another year or two at most.

Ethics and Managed Care
As the changes in technology have escalated, so have the costs of medical care. It has become fiscally impossible and irresponsible to continue to offer unlimited services upon demand. This state of affairs has given birth to many changes in medical care, including the emergence of “managed care.”

Like any other new endeavor, managed care burst upon the scene with perhaps more speed than planning, and the growing pains have been taking a toll on the practice of medicine ever since, including making it necessary to consider a very fundamental question, which is: Can current medical ethics that apply to individual cases even survive, or must they, like the practice of medicine, become group-based? Consider the impact of the changes in the structure of Physician - Patient relationships that evolved in the 20th century, especially as managed care became the form of health insurance coverage for the majority of US patients.

One hundred years ago there was a one-to-one relationship in which ethical judgments had to be made.

In most instances the patient sought out a physician, the physician treated the patient, and the patient paid the physician.

FIGURE 1: Physican and Patient

Early in the 20th century this simple structure was complicated by the addition of another element resulting in a three-sided relationship in which ethical judgments had to be made.

FIGURE 2: Physician, Health Insurance Company and Patient

Under this model the patient had health insurance, the patient sought out a physician, the physician treated the patient, and the patient’s health insurance company paid for all or part of the physician’s services. There was no contract regarding care between the physician and the patient’s health insurance company, and the physician’s ethical choices continued, for the most part, to be steered by her/his one-on-one relationship with her/his patient.

With the advent of managed care, things have changed. The physician facing ethical questions has contracts with both the patient and the patient’s health insurance company. Where the physician was once her/his own boss regarding patient care decisions, now an employment or agency relationship with the patient’s health insurance company exists.

These contracts can create real ethical quagmires for the physician as she/he has to weigh fiscal as well as physical considerations in treatment choices.

Physicians have become more vocal in their criticisms of managed care, and the medical world has made some attempt to respond. Legislation, popularly dubbed “The Patient’s Bill of Rights,” was introduced in Congress partly in order to “...protect consumers in managed care plans and other health care coverage.”

Individual states have created laws to override some onerous managed care dictates. For instance, the state of New Jersey was among the first to pass a law that requires all health care insurers to allow women to stay in the hospital for 48 hours after the vaginal birth of a child, instead of the 24 hours that had become the managed care standard, and 96 hours for a caesarean birth. Subsequently most states followed suit and initiated similar laws. States that do not have their own laws are subject to the Newborns’ and Mothers’ Health Protection Act of 1996 that was signed into law on September 26, 1996. The act stipulates that a woman be allowed to stay in the hospital a minimum of 48 hours after a vaginal delivery and 96 hours after a caesarean delivery.

A follow-up study in 2006 showed that babies who had hospital stays of at least 48 hours were less likely to be rehospitalized within 7 days after discharge.

HIPPA and Privacy
In 1996, the Congress of the United States perceived there was a need for national standards to control the flow of sensitive patient medical information and instructed the Department of Health and Human Services (HHS) to implement federal regulations to create the standards. Those standards were packaged as the Health Insurance Portability and Accountability Act (HIPAA). The HIPAA Privacy Regulations were published in final form and became effective on April 14, 2001.

Initially it was thought that the new regulations were going to make major changes in the way medical information and records were handled inside the practice of medicine. It was felt that the free flow of information between and among physicians for the benefit of the patient would be hindered. While the privacy regulations did add some administrative procedures, they did not make any substantial change in the way physicians had always protected the privacy and confidentiality of their patient’s medical information. Section IV of the Principles of Medical Ethics of the American Medical Association states:

The privacy regulations compliment this admonition.

Over the years the AMA’s Council on Ethical and Judicial Affairs has issued many opinions and interpretations of the Principals and the section cited above. As early as 1977 the Council said:

At first it was thought that the new regulations required a “written” authorization from the patient any time a record was to be released to anyone, including other physicians. Recently an opinion of the HHS Office of Civil Rights, published on its web site, negated that interpretation.

The opinion states that if the possessor of the medical record had given the patient the required HIPAA Privacy Notice—and had the patient sign an acknowledgment and agreement at that time—then the patient’s medical record could be released to another physician or health care provider that was involved in the patient’s care and treatment without the necessity of having a separate written and signed release authorization. The authorization was provided when the patient originally signed the acknowledgment and agreement to the Privacy Notice. However, it must be noted that local or state law may require a separate written release. While the AMA and HIPAA may allow a release without specific authorization, neither supersedes state law. In a 1999 opinion the AMA’s Council stated:

It would appear that there is no ethical conflict between the way physicians have handled patient medical information historically and the new HIPAA privacy regulations.

The Rise of Professional Responsibility
It is not enough to simply respect confidentiality. The physician must be involved in the patient’s total welfare, in some cases advocating for the patient’s rights. This is no easy task in an environment characterized by constant change.

In 2002 the Annals of Internal Medicine published Medical Professionalism in the New Millennium: A Physician Charter. This was a collaborative effort involving the American College of Physicians and the American Society of Internal Medicine (ACP-ASIM), the American Board of Internal Medicine (ABIM) and the European Federation of Internal Medicine (EFIM). The Charter proposes three guiding principles and ten commitment to guide a physician’s ethical decisions.

The Principles of the Physicians Charter are:

The Commitments are to: