Stories featuring issues in bio-medical ethics are ubiquitous in the news; a few recent ones:
Susan Okie reports in the 11-24-00 edition of the Washington Post:
"Researchers, ethicists and health officials attending a conference at the National Institutes of Health this week defended the use of placebos--inert, dummy medicines--as an essential tool for evaluating new drugs, and said giving them to patients in a study often can be justified even when there already is a treatment that works. . . .
"Giving placebos to study participants has ignited a fierce ethical debate, after last month's revision of a key international medical document to declare their use unethical whenever the disease being studied already has an effective treatment. . . .
"There is widespread consensus in the research community that using placebos is unethical whenever withholding an effective treatment would place study participants at risk of death or lasting disability. Certain kinds of medicines, such as antibiotics, cancer chemotherapy drugs and medicines to treat diabetes, are rarely tested against placebos.
"The document, the Declaration of Helsinki, was revised to state that experimental therapies always should be tested against "best current" treatments and that placebos should be used only when no treatment exists.
"But placebos have played a crucial role in evaluating the effectiveness of many other drugs, including treatments for high blood pressure, depression, allergies, pain and anxiety. . . .
"Forbidding the use of placebos "rules out development of all new therapies for conditions for which there are proven therapies," said Robert J. Levine, an ethicist and professor of medicine at Yale University School of Medicine. If researchers had followed such rules in the past, he said, drugs currently used to treat high blood pressure or stomach ulcers never would have been developed because of the existence of older, less-effective treatments."
The 11-10-00 edition of the British Electronic Telegraph reports that parents who have in the past "signed consent forms for a post mortem examination but [who] said that they did not agree to the removal and retention of their children's organs" are outraged over the recent disclosure that such removal and retention is common practice. "The [Diana, Princess of Wales Hospital in Birmingham] has admitted taking 1,500 hearts from children and has asked Dr Margaret Evans, head of Paediatric Pathology at Sheffield Children's Hospital, to carry out an investigation into the ethics. Dr Evans said on the BBC's Today programme yesterday that there had been a misunderstanding among parents and pathologists of what a post mortem examination should involve. Removing organs for examination, said Dr Evans, was essential for medical education purposes."
An AP story in The Post-Crescent (11-9-00) reports that a genetic test has been found to predict whether the patient has the form of a gene which helps the body repair DNA damage resulting from gliomas, an aggressive brain tumor; "testing for the gene type could help doctors tailor cancer treatment."
A story by Denise Grady in the 10-31-00 "Science Times" of the The New York Times about intestinal transplants' being approved by the federal Medicare program, explains how the expensive procedure can be cost-effective: "An intestinal transplant costs $300,000, largely because it requires a long hospital stay . . . [but replaces] intravenous feeding . . . called total parenteral nutrition or T.P.N., [which] costs $150,000 a year per patient." It is said not to be a cure, since it requires anti-rejection drugs and monthy blood test for life, and since rejection might still occur after 5 to 7 years; because intestines—taken from cadavers in this procedure—have high levels of bacteria, fighting rejection is particularly difficult. Under the new rules, Medicare will pay for the transplants "only for patients with irreversible intestinal failure and life-threatening complications from T.P.N.," though researchers predict that the procedure will eventually be available to others.
Hedrick Smith's Critical Condition web site in connection with his recent PBS documentary. (Boardman videotaped the documentary and has put it on reserve for our course; in addition, he has put his videotape of the Moyers' four part special, ON OUR OWN TERMS: MOYERS ON DYING) Read the national survey on health care at that site. See the web sites associated with the Moyers' special at ON OUR OWN TERMS: MOYERS ON DYING outreach site;
With Eyes Open website
A 10/3/00 Los Angeles Times wire reports: "A Colorado couple used genetic tests to create a test-tube baby that would have the exact type of cells needed to save their 6-year-old daughter, doctors said. The case represents the first time a couple is known to have screened their embryos before implanting one in the mother's womb to save the life of a sibling. The baby was born in Denver on Aug. 29. Doctors collected cells from his umbilical cord, a painless procedure, and on Sept. 26 infused them into his sister's circulatory system. The girl is recuperating in a hospital, and within about a week doctors should know whether the procedure was successful."
On September 28, 2000, the Food and Drug Administration approved use of the abortion pill, RU/486. Associated Press medical writer, LAURAN NEERGAARD, reports in the Los Angeles Times: "Mifepristone, which blocks a hormone vital to sustaining pregnancy, only works during the first seven weeks of pregnancy, when an embryo is about one-fifth of an inch; that is earlier than surgical abortions often are offered. . . .
"'For those who choose to have an early termination of their pregnancy, this is a reasonable medical alternative,' said FDA Commissioner Jane Henney, who approved mifepristone based on studies that found it 92 percent to 95 percent effective in causing abortion."
In its 1-15-01 issue, the The New York Times, reports that Britain has begun to allow pharmacies to dispense the morning-after pill without prescription to women who are sixteen or older. Sarah Lyall reports that "Although many groups here oppose abortion on religious and other grounds, abortion [which is legal in Britain until a woman is 24 weeks pregnant] is not a make-or- break issue in British politics and does not give rise to the sort of volatile emotions that surround the subject in the United States."
BENEDICT CAREY, Health writer for the Los Angeles Times, reports in its September 25 issue that medical insurance's best kept secret is "low-cost, high-deductible insurance, sometimes called bare-bones, or catastrophic, protection."
"'Most people don't realize how fast hospital bills add up,' says Michael Chee, spokesman for Blue Cross of California, the state's largest provider of individual policies, for people who aren't covered. 'We're not talking hundreds of dollars or thousands of dollars but tens of thousands. And that's just after the first few days in the hospital.'
"In a recent study, a Harvard researcher found that nearly half of the 1 million Americans who filed for bankruptcy last year did so in part because they couldn't cope with medical bills.
"Chee says Blue Cross' bare-bones coverage has a $2,000 deductible; it then pays 80% of the next $2,000, and everything after that. The policy sells for between $20 and $60 a month, depending on the client's age, among other things. The price goes up an additional $10 to $20 with each family member you put on the plan, says Chee."
According to an editorial in the September 19thThe New York Times, "The Senate will soon vote on a bill making it a federal crime to prescribe drugs to assist a patient's suicide. Any doctors convicted would serve a manatory 20 years in prison. The House approved the bill, known as the Pain Relief Promotion Act, last year.
"The bill is an effort to outlaw physician-assisted suicide nationwide, thereby pre-empting an Oregon state law that allows such medical assistance."
[Late in October, it was reported that this provision was attached to a spending bill which President Clinton vetoed.]
[The Washington Post reported, 11-24-00: "The Pain Relief Promotion Act, sponsored by Nickles and House Judiciary Committee Chairman Henry J. Hyde (R-Ill.), ostensibly clarifies the law pertaining to the administration of pain killing drugs. It classifies the use of pain killers as a "legitimate medical purpose," and seeks to promote better understanding of pain management and palliative care.
"But it bans the use of federally controlled prescription drugs for physician-assisted suicide, and provides penalties of 20 years in prison for violators. Critics contend this would deter doctors from prescribing pain killers to very sick patients across the board, for fear of prosecution."
According to the Washington Post story, the act has been approved by the House twice but has not gone to the Senate floor because of the opposition of a Democratic Senator from Oregon. It notes that a leading co-sponsor of the act is Senator Lieberman.]
The Sept. 19th edition of the Washington Post reports:
"A committee of the American Association for the Advancement of Science called for the creation of a public committee to monitor and oversee the increasingly sophisticated research into genetic modification.
"Much of the research is concentrating on modifying genes to correct health problems in living humans. This is called somatic gene modification and involves changing the genes in existing, mature cells.
"But, the committee said, there is animal research in which there is an alteration of genes that affect future generations. This is called 'inheritable genetic modification,' or IGM."
Not only is the technique medically risky, "'[t]here is a moral problem on the distribution of these benefits," said [Sondra] Wheeler [a professor at Wesley Theological Seminary in Washington]. "Who gets it? Who decides? What criterion do they apply?'"
In a second story in its Sept. 19th edition, the Washington Post reports, "The family of Tucson teenager Jesse Gelsinger, the first person to die from gene therapy, yesterday sued the research team involved in the deadly experiment and, in an unusual move, the ethicist [Arthur Caplan, the director of bioethics at Penn] who offered moral advice on the controversial project. . . . But the inclusion of the ethicist as a defendant alongside the scientists and school was a surprising legal move that puts this relatively new specialty on notice that its members could be vulnerable to litigation over the philosophical guidance they provide to researchers."
A series of investigative reporting by Michael J. Berens
of the Chicago Tribune has disclosed problems nationally from inadequate staffing, training and supervision of nurses in hospitals; the problems resulted from attempts to reduce the costs of hospital care. "The Tribune analyzed 3 million state and federal computer records to create a database that, for the first time, quantifies the hidden role registered nurses play in medical errors. Because of incomplete reporting in the medical field, these numbers only hint at the full scope of the problem."
The Sept. 10 edition of the Los Angeles Times reports on a recent British legal dilemma: "Should the month-old [conjoined or siamese] twins be separated in an operation that will end the life of the weak sister but save her stronger sibling?
"Or should they be left as they are, joined at the abdomen with only one functioning heart and one set of lungs--deliberate inaction that doctors say will end the healthy girl's life along with her sister's within six months?
"That is the choice facing British Court of Appeal justices who admit that the tragic case of 'Jodie' and 'Mary' is keeping them awake nights."
The Roman Catholic family does not want the operation; the LAT reports, "An Italian cardinal has offered the family 'a safe haven' at a hospital in northeast Italy with free medical services for the girls. But lawyers for the parents say they fear that if they tried to leave the country, attorneys representing Jodie and the doctors would apply for the girls to be made wards of the court. "
"While Catholic theologians insist that it is clearly immoral to cut short one life to save another, Robert Winston, a doctor and Orthodox Jew, argued that what is keeping the justices awake at night is that there is no clear-cut right or wrong in this case. . . . He argued that the parents' well-being should be considered and that their religious beliefs and social situation not be summarily dismissed."
"[Many observers] don't want to see the state usurp the right of loving parents to decide their children's fate, particularly when it is the parents who will be left 'holding the bag'--committed to a lifetime of servitude to a disabled daughter with too few resources and a community that could turn against them.
"Others say they fear a medical precedent of using one baby to save another that could someday lead a court, for example, to allow doctors to take organs from an anencephalic baby without parental consent to save another with a congenital heart problem."
"Jonathan Glover, director of the Center of Medical Law and Ethics at King's College, London, argues that the very grayness of this moral dilemma may be reason enough to let the parents decide.
"'This is a matter of convention, and it is very blurry--there is no right answer,' Glover said. 'Ethical beliefs depend on a mixture of rationally worked out principles and a lot of intuitive feelings which are sometimes disregarded as irrational.'"
On Sept.22, the SUPREME COURT OF JUDICATURE COURT OF APPEAL (CIVIL DIVISION) subsequently decided the case: the twins are to be separated. An appeal is possible. In an editorial, the The British Electronic Telegraph (free with registration required) said, "The only unsatisfactory part of the judgment deals with the justification for ordering the operation and so over-riding Mary's interests. Lord Justice Ward framed the decision in terms of self-defence; that the doctors were coming to Jodie's defence in order to save her from Mary's draining of her lifeblood. This does not ring true: the self-defence argument is an awkward attempt to graft legal precedent on to an unprecedented situation."
[It has been reported subsequently that the family has decided not to appeal the decision.]
The Aug. 24 edition of The New York Times reports that "The National Institutes of Health issued long-awaited rules yesterday that would permit . . . federally financed researchers to use cell lines that were derived from frozen human embryos due to be discarded by fertility clinics, usually because the owners no longer wanted them."
In the Aug. 17th edition of the Washington Post, Rick Weiss reports: "A high-ranking British science and ethics commission yesterday recommended that researchers there be allowed to create cloned human embryos for some research purposes, as long as the embryos are destroyed within 14 days.
"The Blair administration said it had accepted the controversial recommendation, along with a package of other proposals relating to human embryo research. The government said it would move quickly to write implementing legislation, which experts said would probably be the world's first to explicitly allow the cloning of human embryos.
"The action would not change an existing British law that makes it a crime to transfer cloned embryos to a woman's womb, where they might grow into babies. And passage is not assured: To take effect, the legislation will have to be approved in an unusual 'free vote' of the House of Commons and House of Lords, tentatively scheduled for the fall, in which individual members will be allowed to vote their consciences instead of along the usual party lines. British observers predicted the vote would be close." . . .
"The new British report, 'Stem Cell Research: Medical Progress with Responsibility,' is from a government advisory panel headed by Liam Donaldson, Britain's chief medical officer. It notes that some people are indifferent about research on very young human embryos and others think it should never be allowed. The report favors a centrist position, saying human embryos should be accorded special respect because of their potential to become people but that sacrificing them is justifiable for research that promises to vastly reduce human suffering.
"British law already allows scientists to use spare human embryos donated by fertility clinic patients for research on fertility, contraception and birth defects. All embryos must be destroyed by the 14th day, when the first evidence of a primitive nervous system begins to appear on the otherwise undifferentiated ball of cells."
In the Aug. 17th edition of the Los Angeles Times, ALISSA J. RUBIN reports: "The number of older Californians without insurance coverage for prescription drugs is increasing significantly, largely as a result of diminishing coverage by HMOs, according to new data.
"Between 1998 and 1999, the percentage of California seniors with no prescription drug coverage rose from 25% to 34%, leaving about 1.2 million without the benefit, according to a study by the New England Medical Center." . . .
"The prescription drug data are part of a larger study comparing the care received by the elderly in managed-care plans to that of seniors in traditional fee-for-service Medicare plans. The larger study is scheduled for completion at the end of this year. However, the data on prescription drugs were presented at a conference this summer."
In the Aug. 17th edition of the New York Times, PHILIP J. HILTS in "Medical-Research Official Cites Ethics Woes" reports: "The chief federal official overseeing the safety and ethics of experiments with human subjects said today [Aug. 16] that conflicts of interest in medical research were so troublesome that 'the system may have gotten entirely out of control' and might have to be reorganized.
"The remarks by the official, Dr. Greg Koski, director-designate of the Office for Human Research Protections, concluded a two-day government-sponsored conference here on conflicts of interest in medical research. Speakers at the conference presented evidence that questionable financial ties between industry and researchers who test drugs or medical devices were more widespread than previously believed." . . .
"He lauded the American Society of Gene Therapy for 'just saying no' with its recently established policy that researchers should be free of significant financial involvement with the companies that sponsor their studies."
USA Today, 7-9-00, reports:
"In a continuing crackdown on mishandled medical experiments, federal health
officials have shut down all government-sponsored clinical trials involving human subjects
at the University of Oklahoma College of Medicine in Tulsa. They acted, officials say,
after concluding that a cancer study there endangered patients' safety.
"A federal watchdog agency issued the suspension June 29 in a letter that accused
university researchers and an oversight board of repeatedly violating federal regulations
meant to protect patients in the three-year-old cancer trial. The letter was obtained by
USA TODAY.
"University officials say the study involved injecting vaccine into patients who were
seriously ill with melanoma, a deadly skin cancer. Officials acknowledge that 26 patients
died, but they say there is no indication that the vaccine caused their deaths. The study
was canceled after an outside clinical research firm hired by the university sharply
criticized the trial and its principal researcher, Michael McGee, who was vice chairman of
the Department of Surgery during the trial. He declined comment.
"The Office for Human Research Protections issued the suspension."
SUZANNE DALEY of The New York Times, 6-20-00, reports from Amsterdam: "In the last two decades, mercy killings and assisted suicide of terminally ill patients have been widely tolerated [in the Netherlands], with prosecution for such acts becoming less and less likely.
"But soon the Netherlands is expected to take a further step with a new bill that would decriminalize such acts if certain criteria are met, giving this country the least restrictive laws on mercy killing and assisted suicide in the world. . . . The new law, which almost everyone here expects will be passed in the fall, could allow help to die for people ranging from Alzheimer's disease sufferers to perhaps even terminally ill children as young as 12. . . .
"Doctors' actions in helping patients to die would no longer be routinely reviewed by prosecutors but instead by a committee of doctors, lawyers and ethicists. To qualify for help to die, a patient's request must be 'durable,' he or she must face 'unbearable suffering' and have no 'reasonable alternative' to death. The doctor must also consult at least one other independent physician before helping a patient to die. . . .
"The new bill introduces for the first time the possibility of an 'advance directive' so that a patient could indicate ahead of time that he or she wishes to die at a certain point. It will for the first time open the door for patients suffering from dementia and Alzheimer's disease to get help dying if they have signed such a directive early in their illness.
"In the past, such patients have not qualified because they are not considered by some to be suffering 'unbearably.' While their condition may cause anguish to their families, they themselves may be unaware of it."
According to the Washington Post, Tuesday, June 13, 2000, discussing the U.S. Supreme Court Case No. 98-1949 decided 6-12-00, Pegram v. Herdrich, a suit attacking the financial incentives given to doctors to control costs:
"In a decision with broad ramifications for the industry and its 185 million patients, the court said health maintenance organizations that provide financial incentives to reduce the cost of health care do not violate the terms of a 1974 federal law that defined the obligations of employee health care plan administrators.
"To hold otherwise, Justice David H. Souter wrote for the court, would undermine a central purpose of HMOs as authorized by Congress and would open the federal courts to a flood of lawsuits against health plans."
NYTimes: Living Wills May 29, 2000: PLANNING FOR DEATH First of two articles; "At Life's End, Many Patients Are Denied Peaceful Passing," By DENISE GRADY.
The The Washington Post, (available free on-line) reports in its March 11 issue: "After nearly a year of controversy and negative findings
capped Friday by the firing of a South African researcher,
physicians are reluctantly concluding that bone marrow
transplants have no role in treating most cases of breast cancer." "The treatment is effective for certain types of cancer, such
as selected leukemias and lymphomas, and researchers hoped it
would work for breast cancer as well." "Only Bezwoda [the South African researcher] reported success at the [May, 1999] meeting, and other
researchers expressed doubt about his findings. On Friday [May 10, 2000], their
doubts were confirmed when U.S. researchers said Bezwoda
had not used the drugs he claimed to have used, did not follow
his own protocol for the study, did not have an appropriate
control group of women, did not obtain informed consent from
his patients and did not even have approval from his university's
human ethics committee to conduct the study."
The The New York Times, (available free on-line) in a Feb. 23 issue, reports on Pegram v. Herdrich, No.
98-1949, a suit against an HMO now before the U.S. Supreme Court. [The plaintiff is "seeking permission to challenge her health plan in a
federal suit that attacked the financial incentives given to
doctors to control costs," charging conflict of interest.]
The Feb. 24 issue of the (free) on-line Slate writes,
"The LAT [Los Angeles Times (which is available free on-line)] fronts the admission to be published
today by the New England Journal of Medicine
that nearly half of its printed reviews of drugs
since 1997--19 out of 40--were written by
researchers with a financial interest in the
companies that manufacture them, in violation of
the journal's stated policy."
ABC News: Stories on Euthanasia. See particularly the Feb. 23 story, "Study Shows Assisted Suicide Can Go Awry," which discusses both the Netherlands and Oregon. [According to The New England Journal of Medicine, scientists from the Netherlands have found that efforts by patients to kill themselves using drugs prescribed by a doctor frequently go awry. Two other studies report that in 1998 and 1999, 57 terminally ill people in Oregon received prescriptions for lethal doses of medicine; 43 used the drugs to take their own lives. ABC News writes, "Based on interviews with doctors and family
members, the Sullivan team found that the
people who sought the option of killing
themselves feared losing their autonomy, not
being able to participate in activities that made
life enjoyable, and losing control of bodily
functions;" and "many patients changed
their minds about suicide after doctors tried to
intervene to make their final days more
comfortable."]
Links to the two U.S. Supreme Court cases on Physician Assisted Suicide
for which "The Philosophers' Brief," discussed in our text on pp. 254-66,
was submitted; the high court decision seems to leave to each state whether
to permit Physician Assisted Suicide and how to regulate it:
![[Boardman; Philosophy]](B_Phil254x100T.GIF)
![[Pic US Supreme Court bldg]](supr_ct_26x22.GIF){kind=small}