- Email: [email protected]
Errors admitted over falsified US cancer data
Lawsuits and practice guidelines 4 out of 10
private
sector
physicians
American Medical . responding Association survey have been sued for medical malpractice. Among obstetricians/gynaecologists, the figure is closer to 60%. In rural counties of Maine-where : physician pay is low-cost of malpractice insurance and fear of litigation often keep . obstetricians and family physicians from delivering babies. To limit such consequences of "defensive medicine", health policy makers nationwide are now studying the Maine Medical Liability Demonstration Project, which since 1992 has allowed some specialists to cite compliance with practice guidelines as an affirmative defence against lawsuits. Under current laws, standards of care to a recent
(Representatives from the state bar lawyers associations are on the project advisory board.) To make guidestate.
and trial
are determined only on a case-by-case basis on testimony of expert witnesses from both sides. Such variability may convince physicians that no true standards exist and that they must practise with a mind toward guessing which one(s) might be applied should they end up in court. Under the Maine programme, however,
state-approved practice guidelines replace the vagaries of expert testimony and make firm and legal standards of care. Guidelines for 20 conditions in 4 "high risk" specialties-obstetrics and gynaecology, radiology, emergency medicine, and anaesthesiology-have been established by advisory committees made up of physicians, insurers, and labour, business, and consumer groups and approved by the
:
lines reflect standards of care available throughout the state, physicians representing small, medium, and large hospitals are on each specialty committee. Although one of Maine’s largest malpractice insurers warned away physicians from the programme ("we don’t want liability to rest on whether or not the doctor missed an item on a check-list", a company attorney wrote), nearly 90% of eligible doctors are participating. The experiment will continue through 1996. David H Frankel 1 Medical
malpractice: Maine’s use of practice guidelines to reduce costs. US General Accounting Office. 1994. US Government Printing Office. GAO/HRD-94-8.
with Institute 97 data, 1-6754 without). trial has recommended that prevention : The tamoxifen breast cancer prevention the study should continue, but the trial has been temporarily stopped, asNational Women’s Health Network has have all NSABP trials (see Lancet April 9,called for its immediate cessation, stating p 908). Women were already being they have lost faith in NCI. informed about the potential risks of tamoxifen before participation in this Richard Horton study, but the consent form has now been altered to take into account these latest 1 Fisher B, Constantino JP, Redmond CK, et al. Endometrial cancer in tamoxifen-treated results, and to include the risk of death breast cancer patients: findings from the from endometrial cancer. The indepenNational Surgical Adjuvant Breast and Bowel dent end-result, safety-monitoring, and Project (NSABP) B-14. J Natl Cancer Inst 1994; 86: 527-37. advisory committee for the breast cancer
Errors admitted over falsified US cancer data Harold Varmus, director of the National Institutes of Health, and Samuel Broder, director of the National Cancer Institute (NCI), have admitted that their departments’ handling of falsified data from national breast cancer studies has been lax. In response to questions from the House Energy and Commerce Subcommittee on Oversight and Investigations last week, Varmus and Broder criticised their colleague, Bernard Fisher, the 75year-old director of the National Surgical Adjuvant Breast and Bowel Project (NSABP) at the University of Pittsburgh, for being arrogant when asked to cooperate with officials investigating the alleged irregularities. Fisher refused to appear before the committee because of stress and he has declined invitations to discuss his part in dealing with the falsified data from Roger Poisson of St Luc Hospital, Montreal (see Lancet March 26, p 784). Not only were data pertaining to a trial of lumpectomy vs mastectomy involved, but there is now also concern about a study of prophylactic tamoxifen for women at high risk of breast cancer. Representative John Dingell, chairman of the subcommittee, suggested that Fisher had delayed for 2 years the release of data showing that tamoxifen is associated with the development of endometrial cancer. These data come from a trial of over 4000 women with node-negative breast cancer.1 Fisher et al report that the annual risk of endometrial cancer in women taking 20 mg tamoxifen daily for at least 5 years is about 2 per 1000. Possibly unreliable data from Poisson at "Institute 97" (St Mary’s Hospital, Montreal) are included in this report, but an NCI press release says that ’, when these data are excluded, the risk remains largely the same (average annual hazard of endometrial cancer as a first event with tamoxifen [rate/1000] =1.6763
:
that
CONFERENCE
Science of sudden cardiac death
.
The 43rd gathering of the American College of Cardiology last month in Atlanta saw one theme emerge with some force: sudden cardiac death (SCD). Those surviving an out-ofhospital cardiac arrest have a 40% risk of recurrence in the first 2 years after the index event and a 50% 3year mortality. 80% of these arrests are secondary to ventricular tachycardia/fibrillation (VT/VF), 10% follow asystole, and fewer than 10% follow torsades de pointes. According to John Camm (London, UK), the prognosis is made grimmer by the fact that there is no agreed therapeutic strategy. : knowlthis uncertainty, Despite edge has been gained about how fatal arrhythmias are generated. The fault underlying SCD may be abnormal impulse formation (automaticity and
underlie torsades and polymorphic VT following congenital and sporadic
long QT syndrome (LQTS). Early after-depolarisations are enhanced by sympathetic stimulation, commonly prescribed drugs (eg, erythromycin), and left-ventricular hypertrophy. Adenosine, a vagal mimetic, can restore electrical stability. Of particular interest, according to Douglas Zipes (Indianapolis, USA), is the heterogeneous nature of auto-
nomic influences in SCD. Autonomic nerve fibres are located in the epicardium; thus proximal lesions could affect otherwise normal myocardium. Pericardial substances can also affect autonomic nerves, especially when there has been autonomic damage leading to denervation supersensitivity of myocardial receptors. As a result, the threshold for arrhythtriggered activity) or abnormal mia generation may be correspondimpulse conduction (following ingly lowered. Meta-iodo-benzyland delayed after-depolarisations). guanidine (MIBG) scans of the Early after-depolarisations could heart can reveal this supersensitivity
early
1029
private
sector
physicians
American Medical . responding Association survey have been sued for medical malpractice. Among obstetricians/gynaecologists, the figure is closer to 60%. In rural counties of Maine-where : physician pay is low-cost of malpractice insurance and fear of litigation often keep . obstetricians and family physicians from delivering babies. To limit such consequences of "defensive medicine", health policy makers nationwide are now studying the Maine Medical Liability Demonstration Project, which since 1992 has allowed some specialists to cite compliance with practice guidelines as an affirmative defence against lawsuits. Under current laws, standards of care to a recent
(Representatives from the state bar lawyers associations are on the project advisory board.) To make guidestate.
and trial
are determined only on a case-by-case basis on testimony of expert witnesses from both sides. Such variability may convince physicians that no true standards exist and that they must practise with a mind toward guessing which one(s) might be applied should they end up in court. Under the Maine programme, however,
state-approved practice guidelines replace the vagaries of expert testimony and make firm and legal standards of care. Guidelines for 20 conditions in 4 "high risk" specialties-obstetrics and gynaecology, radiology, emergency medicine, and anaesthesiology-have been established by advisory committees made up of physicians, insurers, and labour, business, and consumer groups and approved by the
:
lines reflect standards of care available throughout the state, physicians representing small, medium, and large hospitals are on each specialty committee. Although one of Maine’s largest malpractice insurers warned away physicians from the programme ("we don’t want liability to rest on whether or not the doctor missed an item on a check-list", a company attorney wrote), nearly 90% of eligible doctors are participating. The experiment will continue through 1996. David H Frankel 1 Medical
malpractice: Maine’s use of practice guidelines to reduce costs. US General Accounting Office. 1994. US Government Printing Office. GAO/HRD-94-8.
with Institute 97 data, 1-6754 without). trial has recommended that prevention : The tamoxifen breast cancer prevention the study should continue, but the trial has been temporarily stopped, asNational Women’s Health Network has have all NSABP trials (see Lancet April 9,called for its immediate cessation, stating p 908). Women were already being they have lost faith in NCI. informed about the potential risks of tamoxifen before participation in this Richard Horton study, but the consent form has now been altered to take into account these latest 1 Fisher B, Constantino JP, Redmond CK, et al. Endometrial cancer in tamoxifen-treated results, and to include the risk of death breast cancer patients: findings from the from endometrial cancer. The indepenNational Surgical Adjuvant Breast and Bowel dent end-result, safety-monitoring, and Project (NSABP) B-14. J Natl Cancer Inst 1994; 86: 527-37. advisory committee for the breast cancer
Errors admitted over falsified US cancer data Harold Varmus, director of the National Institutes of Health, and Samuel Broder, director of the National Cancer Institute (NCI), have admitted that their departments’ handling of falsified data from national breast cancer studies has been lax. In response to questions from the House Energy and Commerce Subcommittee on Oversight and Investigations last week, Varmus and Broder criticised their colleague, Bernard Fisher, the 75year-old director of the National Surgical Adjuvant Breast and Bowel Project (NSABP) at the University of Pittsburgh, for being arrogant when asked to cooperate with officials investigating the alleged irregularities. Fisher refused to appear before the committee because of stress and he has declined invitations to discuss his part in dealing with the falsified data from Roger Poisson of St Luc Hospital, Montreal (see Lancet March 26, p 784). Not only were data pertaining to a trial of lumpectomy vs mastectomy involved, but there is now also concern about a study of prophylactic tamoxifen for women at high risk of breast cancer. Representative John Dingell, chairman of the subcommittee, suggested that Fisher had delayed for 2 years the release of data showing that tamoxifen is associated with the development of endometrial cancer. These data come from a trial of over 4000 women with node-negative breast cancer.1 Fisher et al report that the annual risk of endometrial cancer in women taking 20 mg tamoxifen daily for at least 5 years is about 2 per 1000. Possibly unreliable data from Poisson at "Institute 97" (St Mary’s Hospital, Montreal) are included in this report, but an NCI press release says that ’, when these data are excluded, the risk remains largely the same (average annual hazard of endometrial cancer as a first event with tamoxifen [rate/1000] =1.6763
:
that
CONFERENCE
Science of sudden cardiac death
.
The 43rd gathering of the American College of Cardiology last month in Atlanta saw one theme emerge with some force: sudden cardiac death (SCD). Those surviving an out-ofhospital cardiac arrest have a 40% risk of recurrence in the first 2 years after the index event and a 50% 3year mortality. 80% of these arrests are secondary to ventricular tachycardia/fibrillation (VT/VF), 10% follow asystole, and fewer than 10% follow torsades de pointes. According to John Camm (London, UK), the prognosis is made grimmer by the fact that there is no agreed therapeutic strategy. : knowlthis uncertainty, Despite edge has been gained about how fatal arrhythmias are generated. The fault underlying SCD may be abnormal impulse formation (automaticity and
underlie torsades and polymorphic VT following congenital and sporadic
long QT syndrome (LQTS). Early after-depolarisations are enhanced by sympathetic stimulation, commonly prescribed drugs (eg, erythromycin), and left-ventricular hypertrophy. Adenosine, a vagal mimetic, can restore electrical stability. Of particular interest, according to Douglas Zipes (Indianapolis, USA), is the heterogeneous nature of auto-
nomic influences in SCD. Autonomic nerve fibres are located in the epicardium; thus proximal lesions could affect otherwise normal myocardium. Pericardial substances can also affect autonomic nerves, especially when there has been autonomic damage leading to denervation supersensitivity of myocardial receptors. As a result, the threshold for arrhythtriggered activity) or abnormal mia generation may be correspondimpulse conduction (following ingly lowered. Meta-iodo-benzyland delayed after-depolarisations). guanidine (MIBG) scans of the Early after-depolarisations could heart can reveal this supersensitivity
early
1029