Old World News: Paternalism No Problem

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A sad episode in British cancer research recently drew to a low-key close in the setting of a parliamentary committee. The committee's investigation failed to throw any light, however, on why trials with doubtful ethics in the United Kingdom often concern breast cancer. Evelyn Thomas was a physiologist with experience of conducting research on humans when she developed breast cancer in the early 1980s. 1988 she wrote: In retrospect, the first indication that I was in a trial came a few days after my mastectomy. The mastectomy patient in the next bed had been seen by a counsellor and given helpful information. The counsellor avoided me, to the extent that a breast prosthesis was given to me by a male fitter more used to fitting artificial limbs.[1] took her some years to get the London teaching hospital where she had been treated to admit that she had been in two randomized controlled trials. One compared postoperative counseling with no counseling; the other had four arms comparing cyclophosphamide, tamoxifen, both together, and placebo. Since Mrs. Thomas was never offered any alternative to mastectomy she later wondered whether that too had been chosen as part of a randomized trial. With great persistence she worked her way through the National Health Service complaints procedure. She might have taken legal action - indeed, the only advice she received from the General Medical Council, which has the statutory duty to maintain professional standards of medical practice, was to do so. But she wanted to know what had happened to her, and to try to prevent it happening to other women, rather than to obtain financial compensation that she would probably have no time to enjoy. She was met with delays and unhelpfulness that eventually became the subject of a further complaint to the parliamentary ombudsman. Along the way, however, she discovered that her personal medical data, in an identifiable form, had been entered into five separate computer systems. And her complaint about being used for research without her knowledge or consent was rejected at the final stage of the complaints procedure. That stage, called professional review, is conducted by two specialists who are nominated by a national body, the Joint Consultants Committee, to review the complaint. Only later did Mrs. Thomas discover that one of the specialists was an author of the protocol of the chemotherapy trial, inclusion in which was the subject of her complaint. So much for independent review. The ombudsman, or parliamentary commissioner, acts also as health service commissioner with powers to investigate maladministration in the NHS. He is not allowed to comment on clinical matters. A House of Commons select committee reviews some of his findings by summoning witnesses to be examined. At the beginning of last December, Mrs. Thomas's complaint was finally examined by that committee even though she had died more than two years earlier.[2] During questioning, Kevin Zilkha, the physician chairman of the research ethics committee (REC, equivalent to an IRB) described how the chemotherapy trial had come to be performed without informed consent. Initially the REC had required informed consent, but the nurse counsellor who had to obtain it reported that it was distressing to patients to be asked for such consent within twenty-four hours of mastectomy. She had wished the timing to be changed, but instead the REC withdrew the requirement for consent altogether. Six months later they had to reimpose it under pressure from the United States, whence came some of the funds for the trial. The latter information drew only one comment, from the chairman of the committee, Sir Antony Buck, MP: It is rather surprising that people who are providing funds from abroad should be able to dictate your modus operandi, is it not? There are some, such as this author, who would wish that more such dictation might take place. …