Diana Brahams

Death of patient participating in trial of oral morphine for relief of postoperative pain

The death of a surgical patient, who had reluctantly agreed to participate in a trial of MST Continus, an oral slow-release morphine preparation, demonstrates the importance of informed consent and adequate communication among care givers. Explanation concerning the trial as well as consent were limited to an oral format. During recuperation from surgery, the patient was found comatose. No conspicuous label to indicate participation in the trial was affixed to her chart or bed. When the original physician in charge left the hospital, his successor did not inform the surgeon, gynecologists, or junior staff caring for the patient of the clinical trial. Thus, recognition that the patients condition was caused by delayed absorption of the morphine came too late.

Doctor's Duty to Inform Patient of Substantial or Special Risks when Offering Treatment

A 21 February 1985 House of Lords decision in the case of Sidaway v. Bethlem Royal Hospital was concerned with the minimum requirements of the doctors duty to volunteer information to patients on the risks of treatment, particularly surgery. The judgment, that adequate information had been given to Mrs. Sidaway, was in accord with the traditional standard evolving from the 1957 case of Bolam v. Friern Hospital Management Committee, which based the standard primarily on competent medical opinion. The judgment added a proviso, however, allowing court intervention if medical opinion does not support the giving of enough information to enable the patient to reach a balanced decision. Brahams describes the diverse arguments of the five judges involved, and comments on the effect that patient inquiries might have in determining the level of risk necessitating disclosure.

Jehovah's Witness Transfused without Consent: a Canadian case

community, a formerly integrated health service will be fragmented and turned into a two-tier system. Administrative costs, which at 4-5% of total expenditure were the cheapest in the world, will have to soar. The biggest absurdity of all is that the Government will be introducing a market system without a proper pricing mechanism. But ministers have belatedly conceded that individual hospitals will be unable to work out their individual costs. Instead, there will be a national tariff. Ministers dislike the term but

Kidney for Sale by Live Donor

2 conferences were held in London in mid-July 1989: the Royal Society of Medicines meeting on Oral Contraceptives and Breast Cancer and the Issue of Informed Consent July 17-19, and the American Society of Law and Medicines 2nd conference on Health, Law, and Ethics on July 16-21. The Oral Contraceptive meeting was well-organized, with time to discuss issues over lunch. Its aim was to get a panel of experts together to reconcile whether oral contraceptives increase the risk of breast cancer. It is obvious that many factors influence the risk, such as age at menarche, length of breast-feeding, type of pill formulation, length of use before 1st term delivery, and diet. Many of these factors have changed because of social norms or medical practice since relevant studies were done. The speaker summing up the conference suggested that there may be a slightly increased risk, say 1/1000. Generally the pill prevents more disease than it causes, however. Women should be advised forthrightly and reassured that small risks should be accepted in the proper context. The other conference was a contrast as meetings go: too much content--how the law regulates issues across the lifespan, too expensive, too large a hall, insufficient audience participation, no lunch discussions, and poor control over length of presentations. The capacity to consent to bodily harm is explored in relation to the trade in kidneys obtained from impoverished healthy live donors for cash. The British medical profession has unambiguously condemned the practice, but the law in Britain allows a donor to consent to serious injury where the act had some social purpose, recognized by the law as valid. Allegations against the private Humana Hospital Wellington that indigent Turks were brought to Britain to be paid kidney donors, and similar practices elsewhere, are discussed. Questions are raised about the illegality of such contracts in Britain and the possibility of a Parliamentary Act making brokerage and involvement with such cash transactions a criminal offense.

Randomised Trials and Informed Consent

A British barrister analyzes the strengths and weaknesses of the recommendations of the Medical Research Councils Cancer Therapy Committee on the ethical aspects of cancer treatment trials. Although the medical community criticizes the requirements of informed consent and randomized controlled trials because of the practical difficulties they create, both are ideals which must be pursued. If patients do not accept that all of the options in a randomized trial are equal and refuse to participate in the trial, initiatives must be taken to ensure that the choices offered are truly equal and that the public and the medical profession are better able to communicate with each other.

When is discontinuation of dialysis justified

The staff of a renal dialysis unit in Oxford, England, determined that further treatment would no longer be beneficial to a mentally handicapped patient who was noncompliant and disruptive. The director of the hostel where the patient lived disputed the units assessment of the patient and contacted the British Kidney Patient Association, which assumed payment for private care with intent to bill the health authority. Articles have appeared in the press, and government authorities have been asked to investigate. Brahams contends that at issue is whether treatment to the bitter end is always in the patients best interests and comments that, if justice is to be done to other patients, treatment should be given to those most likely to benefit. She briefly discusses current policy and possible legal ramifications of the case.

Death of Patient Who Was Unwitting Subject of Randomised Controlled Trial of Cancer Treatment

A British case of an elderly widow who received an experimental cancer drug without her consent is reported. The drug led to her death and the case came to public notice. It was revealed that, since 1980, 250 patients were allocated by random selection into one of three experimental groups without being informed that research was underway. Suggestions are made for eliminating deception or nondisclosure in therapeutic trials.

Incompetent Adults and Consent to Treatment

An Appeal Court review, brought by the Official Solicitor of Great Britain of a justices declaration that sterilization of a mentally handicapped woman would not be unlawful only by reason of her incapacity to consent to it, is chronicled. In cases where the patient is not able to give an informed consent to any treatment, such as when the patient is unconscious or mentally incapable, the doctors duty to preserve life remains paramount. In nonemergency situations court approval is required before procedures such as sterilization, abortion, organ donation, or experimental treatment can be carried out. If the House of Lords supports this holding, the medical profession will need to establish ethical guidelines that indicate the requirements for consultation with other doctors and disciplines and criteria for care of incompetents who cannot consent to treatment.

A baby's life or a mother's liberty: a United States case.

The wisdom of the English courts refusal to grant ward of the court status to a fetus endangered by its mothers way of life is held to be demonstrated by a District of Columbia case, In re A.C., in which a doctor was ordered to perform a cesarean section to deliver a questionably viable fetus of a dying woman, against her expressed wishes. The approach of the United States courts, that proper care for dependent children may override the states interest in bodily integrity, is compared to the British restriction of medical decision making for competent patients to the individuals involved and nobody else as a warning to interventionists in Britain of the negative extremes to which their attempts can lead.

Consent to Abortion on Behalf of a Mentally Handicapped Adult

In In re X (Reeves J, Family Division, 3 June 1987), a British judge, after considering medical evidence that the termination of her pregnancy would be in the best interests of a mentally retarded woman with a mental age of 4-5 years, declared that it would not be unlawful to perform such an abortion by reason only of the womans incapacity to give her informed consent. Although this ruling and a similar one made a month earlier by a different judge reflect the practice that has been generally accepted for many years, the rulings were made on unclear legal grounds because British law currently provides no mechanism whereby anyone can give a valid consent for a mentally handicapped person who has reached the age of majority.