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Bioethikos: Bringing Life to Bioethics

Archive for February, 2016

 

American Doctor Claims Research in India was Unethical

Wednesday, February 17th, 2016 by Dr. Dennis Sullivan

caduce

An American doctor has claimed that a major study of cervical cancer in India was unethical, leading to at least 254 “pointless deaths.” American pathologist Dr Eric Suba has criticized three major long-term studies of cervical cancer, conducted in India between 1997 and 2012. In a lecture given in Mubai last February, Dr. Suba has claimed:

“In my opinion, these studies are the worst betrayals of science and ethics anywhere in the world in the 21st century.”

 

Dr. Suba may have a point. The three clinical trials in question compared an “experimental” group of low-income women screened with pelvic exams and Pap smears with a “control” group of women who had no such screening. The results were predictable: the experimental groups fared better in terms of cancer rates and survival than the controls. Dr. Suba claims, therefore, that the study was “scientifically pointless,” since it was “contemplating a question that has already been answered.”

There is an important ethical question here. The whole idea of a control and an experimental group in a statistical study depends on a principle of experimental medicine known as clinical equipoise, where we don’t really know which group will fare better. Otherwise, who would agree to take part in a randomized study? We’ve known for years that the Pap smear, invented in the 1920s, clearly detects early cervical cancer and saves lives.

The U.S Office of Human Research Protections has already found violations of informed consent in the India study, and a full investigation continues.

Suba Report Details

BMJ Discussion of Clinical Equipoise

 

New Challenges to Brain Death

Wednesday, February 10th, 2016 by Dr. Dennis Sullivan

heart-beat

Since 1969, the Harvard Criteria on Brain Death have provided guidelines for declaring a patient dead, even if the heart is still beating. This has allowed for a significant expansion of organ transplants. Donation occurs while the organ is still viable, resulting in better outcomes for recipients. As a legal, ethical determinant of the end of life, brain death is enshrined as firm doctrine in all 50 states.

Two recent cases in the news, however, have called brain death into question. In Oakland, California, 13 year-old Jahi McMath suffered a catastrophic complication of an operation to treat her sleep apnea. In Forth Worth, Texas, Marlese Munoz, 14 weeks pregnant, suffered a massive pulmonary embolism. In both cases, the patient was declared brain dead. In the case of Jahi, her parents insisted that life support be maintained, in the vain hope that she might improve and survive. With Marlese, her parents wanted to have life support discontinued, but the state intervened to keep her on the ventilator because of the pregnancy.

There are separate ethical issues in the Munoz case, but one thing should be clear: neither parents nor the state should have the power to determine when a patient has died. That is a clinical determination, and brain death is well established in ethics and law. Now, it is certainly reasonable for doctors to permit families to “say goodbye” to a loved one before turning off life support, but that does not change the facts. It is not a matter for debate: both California and Texas law permit doctors to end treatments under such circumstances, even over family objections, and protect physicians against liability for doing so.

Please note: Brain death is not an assault on the sanctity of human life. Religious voices that object to brain death often assert a sort of “Christian vitalism,” that claims physical life should trump everything, perhaps even God’s sovereignty. Modern medical ethics is complicated enough without adding this confusion.

Understanding Brain Death
Controversies about Brain Death
Arthur Caplan on Brain Death