Unethical Experimentation Issues and Concerns

Unethical Experimentation

Issues and Concerns

Unethical Controversies

Researchers' Good Samaritan Obligations

Monitoring Guidelines

Do No Harm

The Dearth of Ethical Guidelines

International Positions

As Openly As Possible

UNETHICAL EXPERIMENTATION

Issues and Concerns

Unethical Controversies man is ethical only when life, as such, is sacred to him, that of plants and animals as that of his fellow men, and when he devotes himself helpfully to all life that is in need of help. (Schweitzer, 2006)

Unethical... morally repugnant and scientifically wrong," are terms to describe "killing human embryos for scientific research," in the article published in The Times Leader on October 27, 2006. ("Embryonic stem...,")

In this article which posits: "The facts and dangers of House Bill 864," the writer argues that not one single disease in man or mouse has been cured or even effectively treated by embryonic stem cell research, which reportedly creates embryos only for the purpose of human experimentation. The promise of cures, the writer adds, is irresponsible and gives false hope to those suffering from disabling disease or injury. "Nazi-esque" is the term James C. Dobson, of Focus on the Family, called stem-cell experimentation and added, "It will lead inevitably later to cloning and ultimately to the harvesting of body parts.'" ("Frist Frosts Religious Right" 15) During August 2005, an article in Fence Post (16) argues that human life is killed in this process of embryonic stem cell experiments; that "somatic cell nuclear transfer" constitutes "scientific lingo for human cloning." Millions of human eggs must be used to produce human clones necessary for experimentation, this article posits. To obtain the eggs, women will likely be exploited, this article stresses.

Individuals who support embryonic stem cell research, albeit, argue this research may help cure diabetes, Parkinson's and other diseases. They insist this experimental practice provides scientists the opportunity to increase understanding of genetic disorders, lead to interventions to replace damaged tissues and create organs for transplant from a patient's cells; thereby solving tissue and organ rejection. Opposition to embryonic stem cell research counters this argument with contending the derivation of embryonic stem cells leads to the human embryo destruction, the same as murder. Opponents further maintain the human embryo deserves the identical rights and respect a fully developed human deserves. Creating and destroying one human embryo to benefit another human is unethical. (Patel, and Rushefsky) Adult stem cell research, on the other hand, is deemed to ethical and to have successfully treated more than 65 diseases to date. Stems used in adult stem cell research can be harvested with no harm to anyone: from babies already born; umbilical cord blood; placental tissue; fat; adult bone marrow; adult cells. ("Embryonic stem...,") Lugosi notes that Liberationists argue the unborn are not yet human beings, as they conceivably, in their opinions, do not possess human being characteristics. The usual technique in this "dehumanizing' argument is to create a list of defining characteristics identifying when personhood begins. The following list depicts numerous Liberationists' artificial boundaries, which, nevertheless correspond to the unborn baby's genuine physical, psychic and social development at varying human development stages. They include:

1. Moment of conception (assignment of genetic identity);

2. Beginning of the primitive streak (after which time twinning is no longer possible;

3. Implantation of the embryo in the womb;

4. Formation of the nervous system and sentience (the ability to feel pain);

5. Formation of the cerebral cortex of the brain (the ability to reason is a concern, as well as the logic of paralleling "brain life" with "brain death");

6. Quickening (when the mother can feel the baby move);

7. When the fetus looks like what people expect a human being to look like (morphological similarity);

8. Fetal viability (when a premature baby can survive outside the womb with medical assistance and the help of others);

9. Birth (the moment of fully emerging from the mother's body -- as distinguished from partial birth);

10. Acquisition of self-consciousness;

11. Acquisition of ability to reason;

12. Demonstration of intelligence (a minimum I.Q.);

13. Self-determination (assertion of will);

14. Socialization (the formation of conscious relationships to other people);

15. Memory (the ability to remember), and 16. Aspirations (the ability to look forward to achieving hopes and dreams). (Lugosi)

Researchers' Good Samaritan Obligations

Most moral philosophers, as well as most every day, ordinary people, Hawkins contends, agree that each person has an ethical obligation to assist others in need, albeit, admittedly, this obligation is limited obligation. Additionally, among life's debates, people disagree regarding limits to helping another person. Hawkins argues that researchers, just as others, "have Good Samaritan obligations...."

II. Monitoring Guidelines

Do No Harm

Opponents, particularly those connected to the Do No Harm Coalition, claim current gene therapy developments decrease and/or eliminate the need for embryonic stem cell research. (Patel, and Rushefsky) Concerns regarding unethical, potentially harmful experimentations are being discussed, not only in the U.S. But also in other part of the world. In Israel during October 2006, Shlomo Breznitz, Knesset (parliament) member, proposed a bill to limit human experimentations, stating he will increase pressure on his fellow lawmakers to vote to approve the bill. The move to promote this bill limiting human experimentations evolved "after four Israeli doctors were arrested for allegedly conducting unethical experiments on elderly patients." ("Israeli lawmakers...,") Israeli doctors currently must initially pass rigorous standards to receive permission to experiment on humans. Once they are granted permission, however, their actions are basically unrestricted.

The arrest of the four doctors, who allegedly doctors conducted unethical, as well as, illegal tests on thousands of elderly patients for years, spurred the belief the system regarding experimentation needs to be revised. Twelve patients died during one reported incident, during experiments of briefly after the experiments were completed. These deaths, albeit, were not reported, as the law requires, to the Health Ministry for investigation. Despite top doctors' warnings these experiments were illegal or unethical, the accused doctors continued to conduct their experiments. (Ibid.) Breznitz's proposed law would form a panel to routinely monitor doctors who have received permission to conduct human experiments. Current efforts to counter unethical experiments are not "new." "In 1975, the World Health Organization adopted a revised version of the 1964 Declaration of Helsinki, a document that declared the principles of the Nuremberg Code, in a slightly amended version, to be a universal standard." One addition in the 1975 version recommended that experimentation complying with the Declaration's principles be rejected for publication. Since this time, the majority of professional journals editors have consensually determined not to publish data or studies of ethically uncertain origins. (Freyhofer 160) a) that as a prima facie duty, unethically obtained data should never be used, (b) that such data should be expunged from published works insofar as possible, - that the editors of all journals that have in the past published Nazi data without a statement of moral condemnation should print such a statement now, and (d) that science should at a moral minimum be sensitive to the emotions of the victims from whom it has pillaged data." (Ibid.)

Points noted in the ten principles which ultimately became The Nuremberg Code include:

Each human subject's voluntary consent is unequivocally essential. The individual participating in experiments should possess the legal capacity to give consent and able exercise free will to choose, with no interventions of fraud; force; deceit; duress; overreaching, other ulterior coercion or constraint. Participant should comprehend subject matter elements to enable him/her to make an enlightened decision. The purpose, nature and duration of the experiment, along with the means and method it will be implemented, hazards and inconveniences reasonably to be expected, and health which could possible ensure from the person participating in the experiment.

The experiment should yield fruitful results for society's, not attainable by other means of study or methods; not unnecessary in nature, nor random.

The experiment should be based and designed on animal experimentation results, as well as, knowledge of the disease's natural history or other problem under study, with anticipated results justifying the experiment's performance.

The experiment should be conducted to assure all unnecessary physical and mental suffering, as well as, any injury are avoided.

Where there is an a priori reason to believe death or disabling injury will occur, no experiment should be conducted; except, perhaps, in experiments where experimental physicians additionally are subjects.

The determined humanitarian importance of the problem to be solved by the experiment must exceed the degree of risk to be taken.

Adequate facilities should be provided, along with, proper preparation made to protect the experiment's participant against any remote possibilities of injury; disability; death.

Only scientifically qualified individuals should conduct the experiment. The highest level of care and skill should be required through each and every stage of the experiment; of each one who conducts or engages in the experiment.

Throughout the course of the experiment, the human participant should be at liberty to end the experiment if he/she reaches the mental and/or physical or mental state whereas continuing the experiment seems impossible to him/her.

At any stage during the experiment, the leading scientist must be prepared to terminate the experiment, if he/she has probable cause to perceive, that in the exercise of superior skill, good faith, and vigilant judgment required of him/her, the experiment's continuation is likely to result in injury, disability, or death to the participating subject. (Freyhofer 104)

Globalizing clinical research has reportedly proven to be one solution for America's pharmaceutical paradox. Doctors prescribe more than 10 prescriptions for the average American each year. Only one person in 350, however, will submit themselves to be a participant in experimental drug testing. On the other side of the globe, however a profusion of under-treated, poor, physician-trusting patients who live in Latin America, Eastern Europe, and Southeast Asia provide the rapid, positive results needed for new drugs to receive quick approval. One review noted that 99% of controlled trials published in China netted positive results upon the drug/treatment being investigated. (Shah 23) In Nigeria during 2002, thirty Nigerian families filed a class-action suit against Pfizer, who allegedly violated the Nuremberg Code in 1996 as they presided over an experiment on Nigerian children suffering with meningitis. Researchers reportedly forced a risky, unapproved, experiment on unsuspecting subjects who, as a result, consequently suffered hearing loses, paralysis, brain damage, and, for some, death. One recent report by the Health and Human Services (HHS) raised questions regarding ethics in overseas experimentation. Between 1990 and 1999, the number of foreign investigators seeking FDA approvals increased sixteen fold. As companies do not report projects to the FDA prior to conducting research overseas, actual numbers are likely higher. In addition, after approving new drugs, the FDA does not track research by location. (Ibid.) During late March 1996, Pfizer obtained permission from the Nigerian government, who silenced local physicians' criticism regarding the testing of experimental medicine. Pfizer argues a Nigerian hospital ethics committee sanctioned its study design, however, two Nigerian doctors contend, "There was no ethical committee at the time of the trial, none met, and no approval was properly given for the trial." After the experiment concluded, the "approval" document was created and backdated.

Dr. Juan Walterspiel, one of Pfizer's scientists, who prior to and after the study, warned management this study's methods were "improper and unsafe" was dismissed.

Pfizer planned to "give 100 deathly ill Nigerian children experimental Trovan either orally or by injection, and compare their outcomes to 100 others given shots of competitor Roche's FDA-approved Rocephin." The oral form of Trovan, however, was considered too risky to test on the critically ill, mostly malnourished children.

Pfizer, nevertheless, according to Nigerian families forced the sick children to participate in the study, neglecting to inform of the drugs' experimental nature or the availability of WHO-approved meningitis treatment, available at Doctors Without Borders team, located near the experimentation site.

No Helsinki-required informed-consent form was signed, Pfizer admits, neither did any witnesses sign statements, confirming "verbal consent. Elaine Kusel, an attorney who represented Nigerian families suing Pfizer, states: "These people had no idea they were part of any clinical trial." (Ibid.)

In another analysis of a Third World trial, results determined 90% of South African patients participating in a study of HIV transmission felt they were forced to participate in this trial. "Informed consent is a joke," one clinical investigator, working in developing countries, states.

Public Citizen's Health Research Group loudly criticize unethical study designs, yet are not able to appropriately police study conduct, which the FDA and drug industry perceive to be confidential, "proprietary" information. Ethics documents by international the World Medical Association, the WHO/UNESCO's Council for International Organizations of Medical Sciences and other organizations are reportedly alarmingly powerless to insure experimentations are ethically conducted.

Although Pharma companies have ttempted to voluntarily harmonize clinical research standards abroad to comply with FDA standards, efforts remain dreadfully nascent innumerous developing countries. Basically, Shah (23) contends, although voluntary endeavors by Pharma companies to conduct ethical experimentations are necessary, they do not adequately protect those individuals, whose well-being is sacrificed for profits.

Another questionable research practice which involves deliberate human exposure to pesticide chemicals appears to compromise the "do no harm" principle. All pesticide research, by definition, is designed to determine NOELs carries risk of unknown consequence. Some low-level health effects, potential risks, may not present themselves in onset of experimentation and manifest after the testing period's conclusion. In the past, such negative effects have been noted after participants' were exposed to some pesticides considered "safe." (Oleskey et al.) During the past decade, pesticide manufacturers have increasingly tested pesticides in human volunteers, with the obvious goal to establish threshold levels for symptoms, "termed 'n observed effect levels.' Data from these studies have been submitted to the U.S. Environmental Protection Agency (EPA) for consideration in standard setting." (Ibid.)

The Dearth of Ethical Guidelines

Currently, no required ethical study guidelines for pesticides toxicity conducted in humans exists, nor is any governmental oversight implemented. No measures are in place to protect human participants; however, adverse health effects are noted to include cancer, acute and persistent nervous system injury, reproductive organ injury, lung damage, dysfunction of the immune and endocrine system, and birth defects.

Ethical and policy concerns include the dearth of mandatory ethical guidelines for research pesticide that manufacturers conduct and submit to the U.S. EPA. During research, procedures for minimizing harm to study participants and subjecting them to no unreasonable risk are non-existent. Approaches to obtain subjects' informed consent may also be less stringent than those specified by the Common Rule (Office of Science and Technology Policy 1991). Others, nevertheless, have argued testing pesticides in humans is valuable; as humans serve as the best predictor of human toxicity. (Ibid.)

The following list summarizes required elements of informed consent stipulated by the Common Rule:

statement that the study involves research, an explanation of the research, and a description of the procedures to be followed;

description of any reasonably foreseeable risks or discomforts to the subject;

description of any benefits to the subjects or to others that might reasonably be expected;

disclosure of alternative procedures or courses of treatment;

statement describing the extent to which confidentiality of records identifying the subject will be maintained;

For research involving more than minimal risk, an explanation of the availability and nature of any compensation or medical treatment if injury occurs;

Identification of whom to contact for further information about the research and about subjects' rights, and whom to contact in the event of a research-related injury; and statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time. ("Chapter 14:...")

III. International Positions

As Openly As Possible

During February 1995, the United States Department of Energy's (DOE) Office of Human Radiation Experiments published Human Radiation Experiments: The Department of Energy Roadmap to the Story and the Records ("The DOE Roadmap"). "The Roadmap summarized work undertaken at the direction of Secretary of Energy Hazel R. O'Leary to find, declassify, and make publicly available DOE records related to human experimentation." Secretary O'Leary's larger openness initiative also committed the Department to conduct business as openly as possible, while providing information needed to assess this agency's past activities. (Human Radiation Experiments...) The Roadmap includes approximately 150 human radiation experiments summaries, as well as, summaries of more than 275 additional studies which are identified; documented; confirmed. Methodological and historical descriptions, topical discussions, and records series descriptions describe a variety of activities from the early 1940s through the early 1970s. The posited intent for this project is to inclusively identify human radiation research projects and help insure the continuation of the Secretary's openness initiative. (Ibid.) The following lists International Laws regarding the ethical issue of stem cell research for experimentation:

1.Great Britain - Great Britain's law, the to allow limited human cloning for the purpose of cloning stem cells from human embryos (amending the Human Fertilization and Embryology Act of 1990, passed in January 2001, amidst strong, vocal opposition from religious leaders. Following seven hours of Parliamentary debate in Parliament, proponents of prevailed by a vote of 212 to 92. (Stevens) Great Britain's law:

Guarantees that a committee of experts would closely examine ethical and scientific aspects of the issue won over opponents and allowed the victory. It should be noted that human cloning in Great Britain remains illegal. Furthermore, regulations mandate that any embryo involved in stem cell research cannot be used after fourteen days. (Ibid.)

2. Australia - In 2003, Australia had not yet passed federal legislation regulating stem cell research. In some part of Australia, stem cell research is legal; however, legislation differs throughout Australia's six states and two territories.

For example, Tasmania, Victoria, Western Australia and South Australia have laws regulating cloning and stem cell research. The Federal Cabinet, faced with a proposal to ban the use of embryo cells, decided the ban would not be appropriate without further consultation.

Australia's national and state governments have jointly agreed to develop uniform legislation that bans human cloning, but allows human stem cell cloning for medical research. (Ibid.)

3. China - In November 2000, China's Ministry of Health officially announced the Chinese government would permit embryonic stem cell research for treatment and prevention of disease, providing research is rational and effectively monitored. All human cloning experimentation, on the other hand, is reportedly forbidden.

Many Chinese scientists are urging lawmakers to quickly enact legislation completely banning reproductive cloning to prevent misuse of technology. The sentiment of those scientists, however, is not shared by all, as teams of Chinese scientists have reportedly cloned dozens of human embryos.

The Chinese government has made it clear that it wants its biomedical industry on par with the West. It has established extensive state programs to further that goal, pouring in millions of dollars for research projects. (Ibid.)

4. Japan - In Japan, considered a home to most of the major religions, biotechnology is controversial. During August 2001, however, a Japanese Cabinet panel approved strict stem cell research guidelines:

One provision states that "embryonic cells used in research would be taken only from those made for fertility treatment that would otherwise be discarded." Like the United States, where federal funding is limited to research involving currently existing cell lines, the Japanese government will not allow the creation of embryos specifically for stem cell research. The guidelines also specifically ban research aimed at finding potential medical applications or any other use of stem cells. The provision means that scientists will only be allowed to conduct basic research. Additionally, like the United States, the Japanese government has placed a ban on human cloning research. The ban is particularly important because Japanese institutes are leaders in cloning research, regularly cloning cows and other animals on a regular basis. (Ibid.)

5. Germany - In Germany, as in Japan, biotechnology constitutes a particularly controversial topic. Memories of Hitler's Third Reich quest for a pure race and horrific human experiments in Germany fuel current debate regarding unethical experimentations.

Germany's government is considering allowing research on embryonic stem cells. German officials have indicated that the country's ultimate decision could be influenced by the direction taken by the United States.