Japanese police are investigating a surgeon who has killed seven patients over the last five or six years by removing them from their respirators. The 50-year-old head of the surgery department at Imizu City Hospital, 260km northwest of Tokyo, allegedly wanted to allow his patients to die with dignity. According to hospital authorities, he consulted his decision with relatives first, but he never discussed the matter with the hospital ethics committee. Four men and three women -- all between the ages of 50 and 90 -- are said to have been killed. Five had cancer.
The case only came to light when the head nurse of the medical ward overheard the doctor instructing a staff member to remove an artificial respirator from a 78-year-old stroke patient. Hospital staff had been cooperating in the deaths. "In the surgery ward, the staff works in teams and no one could refuse his orders," the director of the hospital, Hidetsugu Asanoi, told the media. "I believe he made the decisions taking full responsibility and with faith in his own way [of doing things]."
However, a relative of the stroke patient denied that the doctor had asked for consent. "We had not demanded that the respirator be removed. The surgeon did not obtain our consent," he said.
This case has raised the issue of euthanasia once again in the Japanese press. According to the Daily Yomiuri, a 1995 court case set down some principles. "Active euthanasia" is allowed when four criteria are satisfied: unbearable pain, proximate death, no other way to relieve pain; and clear consent. Passive euthanasia, without consent, is also allowed if relatives consent.
However, these guidelines are unclear and the Health, Labor and Welfare Ministry is drafting new ones for terminal medical care, including those for life-prolonging treatment and confirmation of patients' wishes. These should be ready next year. ~ Japan Times, Mar 27; Yomiuri Shimbun, Mar 27;
TWO LEAVE HOSPITAL AFTER DRUG TRIAL DISASTER
Two UK men have been discharged from hospital after collapsing during a drug trial earlier this month. Four others are still in Northwick Park Hospital, in London, one of them critically ill. All six were paid volunteers for a Phase 1 clinical trial of a new monoclonal antibody drug, TGN1412, but collapsed with great pain, fever, convulsions and organ failure almost immediately after it was administered.
Solicitor Martyn Day, who is representing four of the men, said: "Our clients are pleased to be recovering but are very anxious about their futures at this time. We are looking for an early meeting with the drug companies to ensure that financially our clients can get their lives back in order as speedily as possible without recourse to the courts."
The disastrous incident is being investigated by UK health authorities and the police. The German drug company, TeGenero, and the American company running the trial, Parexel, still cannot explain what happened.
The mysterious failure of TGN1412's Phase 1 trial has cast a shadow over an American proposal to hold "Phase 0" trials, Nature reports. The US Food and Drug Administration has announced that small doses of experimental drugs can now be tested in people before embarking upon full-scale trials. This, hopefully, will streamline the cost of putting a drug on the market (currently more than US$1 billion) and make it easier for university researchers to promote drug candidates.
There are some ethical issues. Because the doses are tiny in a Phase O trial, there will be no benefit to participants even though there will be some risk. Senator Chuck Grassley, of Iowa, complains that The FDA is loosening the reins on drug companies. I'm concerned for those who will be receiving these experimental drugs." An FDA spokeswoman countered that these trials would actually decrease the exposure of humans to drugs which fail -- "which right now is the majority of them". ~ BBC, Mar 28; Nature, Mar 23
INBRED BEDOUINS GET GENETIC COUNSELLING
In a rare example of Israeli and Palestinian cooperation, doctors on both sides of the border are analysing the high proportion of genetic diseases amongst Bedouins. An estimated 140,000 of this nomadic people live in the Negev desert in the south of Israel bordering Gaza. Since about 65% marry first or second cousins, they have significantly higher odds of having children with rare genetic diseases. Two genetics institutes in Beersheba are trying to identify the mutant genes and offer genetic counselling and prenatal testing.
Some of the diseases are terribly disabling: aplasia cutis, in which babies are born with no skin on their skull; severe mental retardation; congenital insensitivity to pain; phocomelia, in which limbs are short and twisted; and eye sockets without eyes. The research has made Israel an important centre for the study of inbreeding.
There are no cures for these diseases, so the counselling is oriented towards aborting disabled children. According to the New York Times, more than 20 couples chose to end their pregnancies last year. Muslim religious leaders are helping by making people aware of the dangers of marrying cousins and the possibility of genetic counselling. They also advise people that Islam allows a woman to abort a child up to four months for health reasons.
The counselling is a two-edged sword, the researchers have learned. In a small society, there is a danger of stigmatising carriers of disease, making marriage harder for them and their families. Illness is also associated with weakness and loss of family honour. Counselling therefore requires great cultural sensitivity and confidentiality. ~ New York Times, Mar 21
GERMAN STEM CELL ADVANCE MAY AVOID USE OF EMBRYOS
German scientists have announced that stem cells from the testicles of mice may be as useful as embryonic stem cells. "If this turns out to be true, it will be an exciting advance," said George Q. Daley, a leading stem cell researcher at Harvard Medical School. The discovery opens up the possibility that similar cells will be found in adult men.
The key advance in the German research, at Georg August University in Goettingen, was not just isolating spermatogonial stem cells, which generate sperm, but creating a growth medium which coaxes them into becoming cells which can generate any kind of tissue. These cells are called "multipotent adult germline stem cells", or maGSCs. The German team was able to differentiate the maGSCs into beating cardiac and vascular cells, neurons, skin cells and liver cells. More stringent tests remain to be done to confirm the findings.
Critics of the use of stem cells derived from embryos were cautiously optimistic. "This is a big step in the right direction," says Dr Tadeusz Pacholczyk, of the National Catholic Bioethics Center in Philadelphia. "The fact that ethics is being taken seriously in a number of quarters such that alternatives are being explored is a very encouraging development."
The leader of the German team, Dr Gerd Hasenfuss, supports research in both adult and embryonic stem cells. But in Germany, scientists are banned from research on embryos, so he has worked for years to derive multipotent stem cells from adult tissue. This is his first success. ~ New Scientist, Mar 24; Boston Globe, Mar 25
And in Los Angeles, a biotech firm claims that it has also discovered "a very primitive stem cell with properties that are similar to embryonic stem cells". Scientists at Moraga Biotechnology Corporation say that these primitive cells "blastomere-like stem cells" differentiate into most tissues and organs in the body. ~ Moraga press release, Mar 20
TRAUMA TRIALS STIR CONTROVERSY
No experimentation without consent is one of the few ethical principles which is universally accepted by bioethicists. But some exceptions are needed for studies of non-competent patients and emergency medicine. One of these has prompted a fierce debate: a US trial of an experimental blood substitute for accident victims. The product, PolyHeme, is made by an Illinois company, Northfield Laboratories, which has enlisted 32 hospitals throughout the country.
In areas covered by the trial, the company has consulted with the local community to explain what happens. The only way to opt out is to wear a blue wristband. Critics say that community awareness is low, there is little public awareness of the risks and consultation has been inadequate. The trials tend to take places where there are lots of trauma -- mostly poor towns with ethnic minorities. Another issue is supposed lack of information about the results of the trial. It is also under fire for not disclosing the results of a study which apparently showed that some patients suffered heart attacks.
The PolyHeme study is being observed carefully because other "no consent" trials are under way. In the coming months, a $50 million National Institutes of Health research project will test experimental techniques on trauma and heart-attack patients who cannot give consent. ~ Nature, Mar 23
DOCTORS WHO EXECUTE
The American Medical Association has decried the participation of doctors in executions as a clear violation of medical ethics. Nonetheless, since all 38 states with the death penalty use lethal injections, doctors are needed -- and doctors do participate. In the latest issue of the New England Journal of Medicine some of them explain why.
There was a range of reasons cited by the four interviewed. Most became involved only gradually. Typically, they lived in an area near a prison and agreed to witness the execution and issue a death certificate. After attending a few times, they became more and more involved. One doctor felt that the criminals deserved death for their crimes -- and didn't know that participation violated the AMA's code of ethics. Another wanted to ensure that the prisoner did not suffer unnecessarily. Another, Dr Carlo Musso, of Georgia, opposes the death penalty, but believes that his "patients" need comfort in their dying moments so that death happens painlessly and humanely.
Even though the number of doctor-executioners is very small, the author of the article complains that "their actions have made our ethics codes effectively irrelevant in society". This is important, he argues, because of the increasing tendency of the government to subvert medical practice for its own purposes, such as cooperation in the torture of terror suspects.
Although he recognises that some of the doctors have reflected on their own ethical stand and seem to be people of integrity, he says that they should be prepared to face the consequences of their decisions. Unfortunately, he said, the doctors and nurses he interviewed chose to remain anonymous and evade that responsibility. The exception, Dr Musso, gives his side of the story on an NEJM podcast. ~ NEJM, Mar 23
HWANG-GATE
More details about the golden years of disgraced stem cell researcher Hwang Woo-suk have emerged in a book by a Korean journalist. Lee Sung-joo, of the newspaper Donga Ilbo, accuses his colleagues in "The Country of Hwang Woo-suk" of giving Hwang a dream run in return for lavish favours. In one instance, Hwang pressured two newspapers to go easy on a scandal surrounding the president of his university.
Hwang also gave reporters his own credit card to use on meals and drinks. Several reporters were given "scholarships" as a reward for their loyalty, including Yonhap News Agency, Chosun Ilbo and KBS broadcasting. Although some reporters were objective, Lee says, others acted like members of Hwang's public relations team. ~ Ohmynews, Mar 27
IN BRIEF: stem cells, organ donors, cosmetic surgery...
Bioethics conference: Conservative and liberal bioethicists will hash out their differences at a July conference in Albany, New York. The Future of Bioethics in a Divided Democracy" is sponsored by the Alden March Bioethics Institute. The speakers range from pro-life advocates like Nigel Cameron, Richard Doerflinger and Wesley Smith to utilitarian writers like Arthur Caplan, Glenn McGee and Alta Charo. ~ blog.bioethics.net
Australian stem cell debate: The Australian Parliament is preparing for another passionate debate on the legalisation of therapeutic cloning. Federal MPs on both sides of the ethical divide are claiming that they need a conscience vote on the contentious issue. The recent Lockhart Review, by an independent committee, recommended that many restrictions on embryo research be liberalised. ~ The Age, Mar 23
Israeli organ donors: Israelis who have had organ transplants will not be able to claim on their health insurance unless they can prove that they obtained the organ legally and without duress. Until now, no documentation about the donation was needed. There have been some scandals in which organs were purchased from Third World people who gave away their organs solely for the money. ~ BMJ, Mar 25
UK abortion row: A Catholic hospital in north London has been told by the leader of the Catholic Church in England and Wales not to refer patients for abortions, contraception, tests for foetal deformities and the morning-after pill. "A Catholic hospital cannot refer people for abortions," said a spokesman. "They can't say you can't have it here but there's a place just round the corner." The hospital, St John and St Elizabeth Hospital, has apparently been following government guidelines which demand that doctors with qualms of conscience refer patients on to a more compliant colleague. ~ BBC, Mar 20
Vietnamese cosmetic surgery: Vietnamese officials are despairing of controlling a burgeoning cosmetic surgery industry. The Ho Chi Minh City health department investigated 200 private clinics this week after a woman with breast implants died from an infection. It found that even at the city's 40 licensed cosmetic surgery clinics, half were providing unauthorised procedures and consultations. ~ VNS, Mar 27
