Director of public relations and ethics: urgent hospital issues

Hospital Ethics

TO DO or NOT to DO

Abortion

Pro-life and pro-choice advocates clash over this issue, which centers on life or human life and what it really means (Oliver 2005). As Mother Theresa and Yasser Arafat said, personhood refers to "the nature of someone like us and entitled to the same protection of the law." The first issue focuses on whether the fetus is a person or has that personhood. The second issue determines the proper behavior when there is disagreement on the first issue. Among the questions to settle are when personhood begins, what life is and if life exists independently of mortal thoughts. Reason tells that it is not dependent on human determining. The human mind is imperfect and quite often incorrect. It also changes often. In that sense, the State would be incorrect and morally wrong in deciding that a Black person is not a life or a person. Neither tradition nor science has helped very much. Science admits that a fetus is alive and human and possesses DNA distinct from its mother's. In the landmark case, Roe v Wade, science fixed the personhood of a fetus to the stage of viability. This implied that abortion is allowed before the stage of viability. But legislations cannot stand on this position. Two mistakes can quickly follow from it. One is allowing abortions if the consensus is that the fetus is a person. The other is prohibiting abortions if the fetus is not a person. As the debate statement says, if there is a chance that abortion may irreversibly damage a human being, lack of certainty on its personhood cannot be a reason to allow it. The choice must be made despite the lack of certainty on that personhood. Those who allow abortion should be ready to be seriously wrong. And those who oppose it should decide on how to behave towards that lack of certainty of the fetus' personhood. All sides would adopt a "precautionary principle" and not accept the risk of killing a human being. The Precautionary Principle states that scientific certainty of harm is not necessary in taking action to avoid or avert the harm (Oliver).

The Supreme Court decided in Roe v Wade that before the viability of the fetus, a woman could not be prohibited from exercising her "right to privacy," including procuring an abortion (Oliver 2005). In 1973, this viability was established at 28 weeks or earlier. After this period, it ruled that the State must safeguard the life of the fetus, except when the life or health of the mother required an abortion. In another decision, the Court so defined and expanded maternal "health" as to limit the states' ability to protect the fetus after viability. The Court thus fixed its own definition of life as "viability." By not referring to the fetus as "life," it implicitly authorized its destruction (Oliver).

An online Harris poll indicated that those who supported the Roe v Wade decision had gone down from 57% in 1998 to 52% in February, 2005 (Hollander 2005). In comparison, those who opposed the decision increased from 41% to 47%. Fifty-one percent of American adults said they were pro-choice, while 44% said they were pro-life today. In 1992, the same Harris poll reported that 58% were pro-choice and 35% were pro-life. Only 23% of them would allow abortion in all circumstances. In comparison, 55% would allow it in certain situations while 21% rejected it in all circumstances. The proportions have essentially remained through the years. The number of those who supported tighter restrictions went up from 34% to 42% between 1992 and 2005. On the other hand, those who favored easing restrictions decreased from 18% to 13%. Today as in 1998, 3 out of 5 Americans believe abortion should be legalized in the first three months of pregnancy, 1 in 3 during the next three months and 1 in 10 during the last three months (Hollander).

Issue 2: Germline Experimentation

Reproductive regeneration or cloning is welcomed by those with infertility problems and want to have their own biological child (Billings 2002). The trend began with the birth of Louise Brown following in vitro fertilization or in a test tube instead the natural womb. The technology has since evolved. The only concerns left were the safety of the mother and the child and who should develop the technology. The fact is that germline experimentation has been confined to animals. The success rate has only reached 3%. At best, it has been a hit-and-miss affair when Dolly was cloned. Scientific advancements, however, now allow up to 80% success with animals. But that success is confined to sheep and goats. It cannot be assumed to work as well on humans. In order to discover or calculate success, germline experimentation must use human subjects (Oliver).

Those who oppose it contend that cloning can seriously adversely affect an entire family (Oliver 2005). It involves the transfer or transplantation of the nucleus and the genome within from a mature cell into an a-nucleated human egg or stem cell and the implantation for gestation and birth. Human development involves an entire process. This includes chromosome changes, rearrangement of genes and the change of size of DNA segments. Successful cloning requires a reprogramming of this process. During the transfer, the genome can be manipulated and bring on germline genetic changes. These changes will affect an entire family. There is as yet no guarantee of system safety. So far, observed effects have included premature death and major developmental anomalies. They can only be subtle in human subjects and result in altered mental development or some neurologic functions (Billings).

Scientific probabilities are no longer limited to "creating" human beings in the laboratory. These human beings may also be "designed" according to specifications. Princeton University microbiologist Lee M. Silver believed that, by 2010 to 2050, parents could ensure that their offspring would be free of certain predetermined defects (Deneen 2001). Parents could have an extra gene inserted into single-cell embryos within a day after conception to ward off AIDS, overweight or alcoholism. Professor Silver was referring to the Human Genome Project, which on June 26, 2000, completed the draft of a genetic blueprint for a human being. Many details were still needed to create a human being from scratch but the attempt had been started. This 15-year project should be completed in 2015 at a budget of $3 billion. Creating the human genome would need identifying 3.2 billion chemical "letters" in DNA strands found in every human cell. Researchers already know the arrangement but not all the chemical "letters." These contain the instruction in producing the proteins making up the human body. Approximately half of the sequencing task had been completed (Deneen).

If the experiment succeeds, Professor Silver foresees that a few centuries from now, there will be two species of human beings: the standard "natural" and the gene-enriched (Deneen 2001). Gene-enriched people will be those elite children produced from costly designer genes. They may be free of cystic fibrosis, diabetes, heart disease and other big killers, alcoholism and mental illness. The American Association for the Advancement of Science said that experiments cannot be safely and responsibly conducted on human beings without reliable techniques for gene correction or replacement was developed according to standards. Genome supporter-scientists said that the question was not whether genetic manipulation should occur or be done but only how and when.

Analysts argued that now would be the time to sort out the ethical and societal implications of our global and scientific society. Find out if we really want to modify nature. It is also important to consider that many nations have banned genetic engineering but the United States has not (Deneen).

Issue 3: Randomized Clinical Research

Before any drug is introduced into the market, it must pass many and prolonged tests and scrutiny (National Women's Health Resource Center 2005). It must withstand lab experimentations, clinical trials on human beings and the scrutiny of the Food and Drug Administration. FDA review and approval can take 10 or more years. Clinical testing is the supreme test of any new drug. Even approved drugs are monitored for long-term safety and effectiveness. Trials are performed throughout the U.S.A., in major cities and small towns, in universities, hospitals and doctors' offices (NWHRC). But the risks involve the participation of human subjects.

Reports say that every year, more than 100,000 patients take part in clinical trials conducted by the National Institutes of Health (NWHRC 2005). Many of them are very ill patients who need more effective treatments. Others want to contribute to medical advancement. Benefits in participation include access to new treatments not yet available and the chance to help others, contribution to medical research and access to top medical care. If the new treatment is effective, participants may be offered the treatment. There are risks too. It may cost them some inconvenience, side effects or adverse reactions. The design of the trial may require them to go to the study site or hospital or undergo difficult or uncomfortable procedures (NWHRC).

The clinical trial team includes doctors, nurses, social workers, data entry technicians and other health care professionals (NWHRC 2005). They review a participant's health history and current medical intakes before the trial begins. They impart adequate information and instructions about the clinical trial, monitor each participant in the conduct of the trial and may contact the participant after the conduct of the trial.

Clinical trials or researches may also be open-label, placebo-controlled, double-blinded or randomized. They consist of four phases. Phase I establishes the maximum safe dosage; Phase II, its effectiveness; Phase III, its use on a broad population; and Phase IV, post-FDA insights on the effects of its long-term use (NWHRC).

From 1999 to 2000 alone, the Food and Drug Administration approved 73 new medications (NWHRC 2005). These included drugs for HIV, cancer, heart attack and Alzheimer's disease. As of 2000, Medicare covers many of the costs involved in participation in clinical trials or researches. The Institutional Review Board, in addition to the FDA, has to approve new drugs in case of oversight by the FDA. Participants in clinical trials can require more doctor visits and tests than if they did not take part. Researchers need to obtain detailed data on the progress of the treatment. From 1977 to 1993, the FDA prohibited women of child-bearing age from participating in early testing of most drugs to avoid birth defects. But today, they have been allowed again, as long as they are informed about the risks. When a particular drug proves exceptionally promising, the FDA puts it in "priority review" status. If accelerated scrutiny finds the drug suitable for treatment, it can be sent to market much sooner (NWHRC).

New medical devices, procedures and approaches to the treatment of diseases must also prove their worth (NWHRC 2005). Some studies seek to discover if a specific drug is better than surgery alone or earlier treatments can have better outcome. Health professionals who have doubts or questions about the diagnosis or treatment of a medical condition can settle them through the conduct of a clinical trial or research. Even the results of clinical tests must prove their mettle. They must provide "statistically significant" safety and/or effectiveness from mathematical analysis that they are highly likely to be true and not the mere product of chance. Clinical trials may be sponsored by government agencies, pharmaceutical or medical companies, individual physicians or health care institutions. These may be conducted in different locations or settings (NWHRC).

Issue 4: Rationing Health Care

Politicians and educators have not been too willing to confront the looming probability of the need to ration health care (Scott 2004). They refused to admit or even consider it in order to preserve the current health care system. But many healthcare policy leaders have been coming to terms with the dread. And the new Medicare bill signed into law by President Bush was a timely response to the dread. The NAIM was aimed at reviewing the costs of healthcare and limiting them when positive outcomes also seemed limited. It explored into a looming scenario when patients could be denied healthcare services, based on cost benefit analyses. The analyses could decide that the marginal benefit to the patient would not be worth its cost to the country. This would then call for rationing (Scott).

Section 1013, Title X of the NAIM charges the Health and Human Services Secretary to assess healthcare guidelines, reduce scientific uncertainty in healthcare delivery, allocate resources efficiently, and analyze financial effects of a change in incentives and allocation of resources on the healthcare marketplace (Scott 2004). The nation's growing budget deficit would bring the attention to social security and Medicare. The government cannot afford to continue paying benefits at the same level to those who demand them. There was need to either break the contract or revise it. If tax cuts were to be avoided now, future generations may not benefit from this social contract. President Bush endorsed the ideas of advisor Alan Greenspan to adjust healthcare in phases until younger generations could adapt to the circumstances. The forecast was that NAIM would cost the White House $139 billion more than expected. In addition, Medicare trustees found that Medicare would completely run out of funds by 2019. Successive studies have indicated that 30-35% of healthcare money has been misspent on unnecessary, ineffective and less than efficacious services (Scott).

Many of the perceived deficiencies of health care were likely to be issues other than excessive demand (Frankel 2000). These could include the public's unwillingness to accept the limits of effectiveness of health care and self-interest of professionals. Under-investment would be another. And the imbalance between demand and supply with the aging of the population, the appearance of new technology and the consequent increase in expectations would still be another. Rationing could be an approach to these problems. Rationing is aimed at regulating access to health care through measures intended to increase effectiveness, efficiency, equitability, ethicalness and benefits. The British view the ongoing debate on rationing as without scientific basis or rationale. The problem proposed is not in refutable form. The background data are drawn only from assertions, political analyses, and ethical debate. Assertions require data support. The discussion on rationing has been viewed as devoid of appropriate data. Moreover, every illustration of failure is considered evidence of something universal. Biases and claims of representativeness have been accepted as generalized facts. In turn, the persisting failure to satisfy the demands for a number of effective and high-volume procedures has been the cause of mismanagement in the main institution charged with health care. Today, a lot of the failure to meet demand is not necessary. When considering rationing, the inclination is to seek out and overrate the deficiencies involved or take recourse in the promised safety of "dilution." The common and unfounded interpretation has been that centers, which fail to satisfy health care demand, represent a global or universal pattern of failure (Frankel).

Issue 5: Organ Transplants

The United Network for Organ Sharing reported that over 80,000 people in the U.S. anxiously need organ transplants to save their lives and 17 of them die each while waiting and not obtaining what they need (USA Today 2003). Professor of health management would trace the problem to a faulty organ procurement system. There seemed to be trouble in identifying donors and obtaining their consent. The system needed a meaningful performance evaluation. In 1984, the National Organ Transplant Act established a system of nonprofit organ procurement organizations, which would serve the need without competing with one another. The objectives of the organizations were to educate the public about organ donation, provide clinical services to handle organ and tissue recovery, and deal with the donor families during the consent process. In charge of oversight were the Centers for Medicare and Medicaid Services. Observers noted that this function of the organization has been amiss and ineffective. These Centers tallied organ donors per million living residents within the area served by the organizations without considering the population's average age, ethnicity, religion and typical causes of death. These factors influenced the likelihood of the dying person's family to donate usable organs to the Centers. African-Americans would not be inclined to donate organs. This would mean that the Centers would not be able to gather donations in proportion to the population. And the elderly who typically had health problems would be similarly un-inclined (USA Today).

The Organ Procurement and Transplantation Network announced in 2004 that 27,000 Americans had received a solid organ transplant (Warren 2005). This was almost 6% more than the number of transplants performed the previous year. The number of donations from deceased persons had also increased by 11% also over the previous year's figure. In 2004, there were 7,150 deceased organ donors as compared with 6,457 in 2,003. This figure was the second highest yearly increase since the start of recording of such donations in 1987 (Warren).

According to this Network, there were 1,385 deceased donor transplants or 20,041 in 2004 as compared with 18,650 in 2003 (Warren 2005). This showed an increase of 7.4% in these two years. With this increase, deceased donations were more than those donated by live donors for the first time in four years. The margin between the two groups was, however, small. Live donations also increased by 6.966% in 2004 from 6,812 the previous year at a 2.3% increase. A major factor in the increase was attributed to the Gift of Life Initiative led by former HHS Secretary Tommy Thompson. The number of those awaiting transplants decreased to less than 6,000 for the first time in 6 years, according to the public announcement made by the Department of Health and Human Services. The Department's Organ Donation Breakthrough Collaborative was likewise credited for the increase. The increase was, however, shared by both participating and non-participating hospitals at16% and 9.4%, respectively, as compared to that of 2003 (Warren).

Part II - Ethics Committee Composition, Qualifications and Concerns

1. medical specialist - the medical specialist would be vastly knowledgeable on all five issues. He or she would be well-trained and substantially exposed to the issues through readings, advocacy lobbying and exposure or actual practice. His or her chief concerns would center on reliability and safety, suitable sources and the balance between risks and benefits. If abortion would be selectively permitted in the hospital, procedures and equipment should be reliable and safe for both mother and child. He or she would raise the standards of selecting participants in randomized clinical research to reduce risks. More experiments should be conducted on higher animals to assure success in germ-line endeavors before attempting to produce human beings genetically. As to rationing, priorities should be listed and set and whom to serve first or the most and whom to serve last or least. Models of successful organ transplants should be established to guide future transplants. Mistakes or failures should also be rigorously noted and avoided.

2. statistician - He is experienced in sampling, surveys, data gathering, analysis and projections of data. He can handle different types of data, subjects or respondents, methods and measurements. He is updated on the latest statistics specifically on the five topics under discussion. His first concern is that the surveys and studies conducted adequately cover and represent all five topics under discussion. His second concern is that there is sufficient amount or volume of evidence or respondents tested by these studies. And his third concern is the respondents are specifically chosen for the survey.

3. administrative manager - He is an experienced manager for operations and material and human resources. He heads survey teams, medical groups, statisticians and other support groups to carry out tasks under the five topics. He purchases equipment and materials and personnel needed for the tasks. He oversees the entire operations and staffing. His top three concerns are the adequate technical and professional know-how of those implementing the tasks under the five topics; the constant availability of proper products and equipment and tools for the tasks; and sufficient manpower.

4. financial officer - He is an accounting or finance manager who is versed in handling multiple financial operations simultaneously or successively without confusion. He heads a support team of capable accountants. His top three priority concerns are sufficient budgets for current and forthcoming product purchase and operational expenditures; costs incurred by sustaining unwanted babies and overpopulation when abortions are denied; and increasing welfare costs vs. operational costs of governance.

5. health care provider - He or she is the head or representative of the biggest public or private health care organization and knowledgeable about the industry. His or her top concerns are a position on whether or not to cover abortions and organ transplants and how far; the reality of the need to ration health care; the probability or feasibility of covering germline experimentations in the future.

6. An ethical adviser - he may be a priest or pastor or any voted moral leader in his community or field. His concerns are the wrongness or rightness of any or all of the five issues; the nature and extent of the risks and benefits from the tasks; and alternatives available which can address the problems presented by the tasks and avoid ethically wrong choices.

7. government policymaker - he is the government-appointee who will explain government policies and receive inputs from the private sector on these policies. His concerns are the benefits of abortions against the costs; if there is real need for rationing health care; and the benefits of developing a genetically-designed population to the government.

The two additional members:

8. lawyer - he is well-versed in the legal aspects of the five issues. His concerns are if abortion is murder; the legal rights of participants in randomized clinical research; and the legal responsibilities of those conducting the research.

9. sociologist or economist - he or she is knowledgeable and updated on the background, trends and projections of the five issues. His concerns are the impact of each issue on society, prospects of each trend in each issue, and their financial, social, and moral costs to society.

Guide Questions for Committee Deliberations

Abortion: the two sides of the abortion issue; the hospital's medical or ethical responsibilities to those who seek abortion; and the consequences of granting or refusing it

Germline Experimentation: the propriety vs. risks; status of experimentations as to completeness of representation and their reliability; and overall cost to society

Randomized Clinical Trials or Research: strong rationale for embarking into the research; safeguards of the procedure in selecting participants; range of remedies available in case of failure or side effects of the drugs on the participants

Rationing Healthcare: current status; balance between welfare needs and government policies; and alternatives to rationing

Organ Transplants: adequacy of supply of products and appropriateness of the acquisition; their affordability to the majority of those who seek transplants; and consequences of using transplants from dead donors

Part III - Positions on Issues

As a general policy, the hospital treats diseases and diseased conditions, saves lives, promotes health and helps improve the quality of life of patients as far as its resources allow and in the best capacity of its staff. In extreme situations, reason and accepted moral standards will prevail.

Abortion

The hospital does not conduct intentional abortions under any circumstances as a contradiction to its policy to save lives.

In favor - the contention has been on whether a fetus is a person or not. If it is a person, then it is life and cannot be expelled. It is a separate life if it is viable or capable of survival outside the womb. The Supreme Court in the landmark case of Roe v Wade fixed viability at 28 weeks. Pro-choice sectors argued that a woman can then exercise her right to privacy by acquiring an abortion before the fetus is 28 weeks old. The assumption is that the fetus is not yet viable and therefore is not yet life. A woman has the right to do what she wants to her body, including the expulsion of a non-viable fetus. This is the pro-choice position.

In opposition - Pro-lifers argue that the fetus is a life from the moment of conception. Its personhood is not qualified or dependent on viability. Life exists as a continuum rather than in stages. A pregnant woman is pregnant of a person, therefore a life and not anything less. Even statistics reflect a general opinion in support of this argument. Surveys said that more Americans were pro-lifers than pro-choice. Support for the Roe v Wade decision dwindled and opposition increased.

Position - the hospital takes the pro-life position of not providing or allowing abortion for any reason before or beyond the 28th week. If the fetus is the product of rape, the hospital recommends counseling to encourage the woman to complete her pregnancy and then opt to give her child up for adoption. If the pregnancy threatens the mother's health or life, all measures, except abortion, will be exhausted to save both lives.

2. Germline Experimentations

The hospital does not conduct these experimentations and will not cooperate in them. It respects nature and performs curative, not "creative," interventions to the defects of nature in an exploratory way.

In favor - the 15-year Human Genome Project promises a future with fewer defective individuals in populations. It predicts the co-existence of gene-enriched people with standard natural human beings. These gene-enriched people will be designed to be free of diseases like cystic fibrosis, diabetes, heart disease and even mental illness. It is a matter of time. Cloning is an option available to infertile couples who want to have their own children despite their incapacity. These possibilities offer hope to those in irreversible, terminal or incurable diseases or conditions. Genome supporters do not have to justify these possibilities and scientific advancements themselves. The issue is not whether they should be undertaken and should stop because they are here and will not stop. The only issue is when and how these will occur.

In opposition - Despite the excitement, which first characterized cloning, its success rate has been negligible. Scientific advancements with cloning have been limited to a few animals. It has not made concrete promises of success on human beings. Germ-line experimentations require human subjects. Natural human development involves an entire process in the hands of nature. Even successful cloning requires a reprogramming of this natural process, a risky endeavor. If the genome is manipulated during the process, genetic changes will occur. There are as yet no sufficient knowledge about what can result and no guarantee of safety. Premature death and major developmental injuries are only among the observed effects of the interference. Some experts believed it could alter mental development or induce neurologic aberrations.

Position - the hospital does not offer or provide cloning or genome experimentations or services. Its policy is to enhance natural life and growth. It corrects deformities as far as its capabilities and resources allow and within acceptable moral limits. As a policy, it does not venture into risky procedures such as those involved in cloning and genome experimentations. It does not offer services that have not been sufficiently proven to be effective, safe and morally acceptable by the large majority.

Randomized Clinical Trials or Research

The hospital favors taking maximum precautions on participants in trials of this kind. It encourages the conduct of sufficient investigations and non-human experimentations before acquiring human subjects. The hospital does not explore beyond what has been convincingly demonstrated as safe for human subjects.

In favor - science begins with assumptions before it ends in laws or facts. A drug, which is subjected to multiple and severe tests, must be tested on the widest possible range of populations. In the process, it incurs necessary risks among voluntary participants for the benefit of the greater number. Tests and researches are conducted at random throughout the country. They involve schools, hospitals and doctors' offices. They know the value of these trials and they see it outweighing the risks. The participants share this view. That is why there are more than 100,000 of them every year who take part in such researches and tests. They are either ill or only desirous to contribute their bit to medical progress. They see it as a purposeful sacrifice. Sponsors take all necessary precautions for all foreseeable adverse consequences and inform the participants about these possible consequences.