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UK misconduct case raises informed-consent issues
SCIENCE AND MEDICINE
NEWS
UK misconduct case raises informed-consent issues nformed consent is the key parents repeatedly that he would not principle that allows doctors to do use a balloon catheter; and that he did invasive procedures. But when the not have sufficient medical grounds to unexpected is found, when and proceed with the dilation. how should a doctor Deborah was born proceed to an interwith transposition of vention for which the great vessels, written consent has a ventricular septal not specifically been defect, and pulmogiven? This issue is nary stenosis. Before central to charges of the procedure in misconduct brought question, she had this week against undergone two major consultant paediatric cardiac operations, cardiologist James and four cardiac Taylor at the UK catheterisations, three General Medical of which also involved Council. use of a balloon On July 8, 1995, catheter. In each case, 6-year-old Deborah James Taylor at the GMC possible interventions Jenkins died at Great were discussed and Ormond Street Hospital, London consent sought—once as an emerafter the rupture of a balloon during gency while the child stayed sedated. dilation by Taylor of a deformed The parents painted a picture of cardiac stent. Deborah’s parents had Taylor as “one of the old school—that consented to “cardiac catheterisadoctors know best”. Taylor had tion”, but allege that they had suggested, they said, that Deborah’s expressly and repeatedly stated that a recurrent symptoms were not cardiac balloon catheter should not be used in origin and could be related to “because it was too risky”. Taylor family anxiety. Munchausen’s-byadmits that he did not have specific proxy was mooted by Taylor on one consent for the dilation, but denies: occasion as a diagnosis, said Jeffrey that he was aware of the parents’ wish Burke QC, representing the parents. for him not to undertake balloon Deborah’s mother said that she was angioplasty; that he had informed the extremely hurt by the suggestion that National News Press Agency
I
she put her daughter through operations “for attention”. After a second opinion suggested a cardiac cause, “a seed of doubt was planted” about Taylor, said the father. Taylor’s lawyer, Nicola Davies QC, described a pattern of repeated consultations in which parental concerns did not match with examination findings. Taylor arranged several admissions for investigations and review by other specialists, including psychological support and the second cardiology opinion. Before the final cardiac catheterisation, Taylor had not discussed balloon dilation in any detail with the Jenkins, argued Davies, because they had not in fact expressed serious concerns then and because Taylor had not expected to find “anything significant”. The Lancet went to press as the GMC’s Professional Conduct Committee (PCC) was still hearing the evidence, often based on conflicting reports of unrecorded conversations. If the charges are found true, the PCC will then decide whether such actions represent serious professional misconduct. Whatever the decision, expected on March 19, the case seems a clear failure of another central tenet of medicine—communication. Kelly Morris
Newest anti-obesity drug fails to pass FDA muster
S
urprising many analysts, on March 13 a US Food and Drug Administration advisory panel split 5-5 on whether to approve the newest anti-obesity drug, orlistat (Xenical). The main stumbling block was whether orlistat increases breast-cancer risk. Approval had been expected. The panel unanimously backed orlistat in May, 1997, and it was hard to see how orlistat, a lipase inhibitor that works primarily by blocking fat absorption in the gut, could be linked to the nine breast-cancer cases in women taking the drug in the original 4000-patient trials.
THE LANCET • Vol 351 • March 21, 1998
Orlistat’s manufacturer, Roche Holdings, withdrew its FDA application last August to further analyse the breast-cancer risk, reportedly because the FDA wanted to state the risk in the labelling. Roche surveyed all women over age 45 who had been in the trials and reviewed all medical records of those who developed breast cancer. The company found two new cases in the orlistat group, and two more in the placebo group. Roche said that the relative risk of developing cancer—a minimum of 3·6 compared with placebo—was due to chance, and that animal
studies have not shown carcinogenicity. Roche also had two experts review the data. Orlistat neither stimulated nor enhanced tumour growth, the experts stated unequivocally. “The fact that studies don’t reveal a direct carcinogenic effect doesn’t really address whether an indirect mechanism” might be at work, said panel chair Henry Bone (Michigan Bone and Mineral Clinic). It is now up to the FDA to decide whether orlistat will be marketed. A decision is due by May. Alicia Ault
885
NEWS
UK misconduct case raises informed-consent issues nformed consent is the key parents repeatedly that he would not principle that allows doctors to do use a balloon catheter; and that he did invasive procedures. But when the not have sufficient medical grounds to unexpected is found, when and proceed with the dilation. how should a doctor Deborah was born proceed to an interwith transposition of vention for which the great vessels, written consent has a ventricular septal not specifically been defect, and pulmogiven? This issue is nary stenosis. Before central to charges of the procedure in misconduct brought question, she had this week against undergone two major consultant paediatric cardiac operations, cardiologist James and four cardiac Taylor at the UK catheterisations, three General Medical of which also involved Council. use of a balloon On July 8, 1995, catheter. In each case, 6-year-old Deborah James Taylor at the GMC possible interventions Jenkins died at Great were discussed and Ormond Street Hospital, London consent sought—once as an emerafter the rupture of a balloon during gency while the child stayed sedated. dilation by Taylor of a deformed The parents painted a picture of cardiac stent. Deborah’s parents had Taylor as “one of the old school—that consented to “cardiac catheterisadoctors know best”. Taylor had tion”, but allege that they had suggested, they said, that Deborah’s expressly and repeatedly stated that a recurrent symptoms were not cardiac balloon catheter should not be used in origin and could be related to “because it was too risky”. Taylor family anxiety. Munchausen’s-byadmits that he did not have specific proxy was mooted by Taylor on one consent for the dilation, but denies: occasion as a diagnosis, said Jeffrey that he was aware of the parents’ wish Burke QC, representing the parents. for him not to undertake balloon Deborah’s mother said that she was angioplasty; that he had informed the extremely hurt by the suggestion that National News Press Agency
I
she put her daughter through operations “for attention”. After a second opinion suggested a cardiac cause, “a seed of doubt was planted” about Taylor, said the father. Taylor’s lawyer, Nicola Davies QC, described a pattern of repeated consultations in which parental concerns did not match with examination findings. Taylor arranged several admissions for investigations and review by other specialists, including psychological support and the second cardiology opinion. Before the final cardiac catheterisation, Taylor had not discussed balloon dilation in any detail with the Jenkins, argued Davies, because they had not in fact expressed serious concerns then and because Taylor had not expected to find “anything significant”. The Lancet went to press as the GMC’s Professional Conduct Committee (PCC) was still hearing the evidence, often based on conflicting reports of unrecorded conversations. If the charges are found true, the PCC will then decide whether such actions represent serious professional misconduct. Whatever the decision, expected on March 19, the case seems a clear failure of another central tenet of medicine—communication. Kelly Morris
Newest anti-obesity drug fails to pass FDA muster
S
urprising many analysts, on March 13 a US Food and Drug Administration advisory panel split 5-5 on whether to approve the newest anti-obesity drug, orlistat (Xenical). The main stumbling block was whether orlistat increases breast-cancer risk. Approval had been expected. The panel unanimously backed orlistat in May, 1997, and it was hard to see how orlistat, a lipase inhibitor that works primarily by blocking fat absorption in the gut, could be linked to the nine breast-cancer cases in women taking the drug in the original 4000-patient trials.
THE LANCET • Vol 351 • March 21, 1998
Orlistat’s manufacturer, Roche Holdings, withdrew its FDA application last August to further analyse the breast-cancer risk, reportedly because the FDA wanted to state the risk in the labelling. Roche surveyed all women over age 45 who had been in the trials and reviewed all medical records of those who developed breast cancer. The company found two new cases in the orlistat group, and two more in the placebo group. Roche said that the relative risk of developing cancer—a minimum of 3·6 compared with placebo—was due to chance, and that animal
studies have not shown carcinogenicity. Roche also had two experts review the data. Orlistat neither stimulated nor enhanced tumour growth, the experts stated unequivocally. “The fact that studies don’t reveal a direct carcinogenic effect doesn’t really address whether an indirect mechanism” might be at work, said panel chair Henry Bone (Michigan Bone and Mineral Clinic). It is now up to the FDA to decide whether orlistat will be marketed. A decision is due by May. Alicia Ault
885