{"id":3524,"date":"2017-01-19T16:59:25","date_gmt":"2017-01-19T16:59:25","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/wmj3.pdf"},"modified":"2017-01-19T16:59:25","modified_gmt":"2017-01-19T16:59:25","slug":"wmj3-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/publications\/world-medical-journal\/wmj3-2\/","title":{"rendered":"wmj3"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"<p class=\"attachment\"><a href='https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/wmj3.pdf'>wmj3<\/a><\/p>\n<p>WorldMMeeddiiccaall JJoouurrnnaall<br \/>\nVol. No.3,september200450<br \/>\nOFFICIAL JOURNAL OF THE WORLD MEDICAL ASSOCIATION, INC.<br \/>\nG 20438<br \/>\nContents<br \/>\nEEddiittoorriiaall<br \/>\nFifty Years Of Smoking Research 57<br \/>\nPublic\/Private Financing and Health Research 58<br \/>\nGenetics Underlying Diabetes 59<br \/>\nMMeeddiiccaall EEtthhiiccss aanndd HHuummaann RRiigghhttss<br \/>\nMigration of Health workers:<br \/>\nCritical issues in the global debate 60<br \/>\nBiomedical Research In Europe 64<br \/>\nUN Standard Minimum Rules for the<br \/>\nTreatment of Prisoners 66<br \/>\nMMeeddiiccaall SScciieennccee,, PPrrooffeessssiioonnaall PPrraaccttiiccee<br \/>\naanndd EEdduuccaattiioonn<br \/>\nMedical Associations and Global Health<br \/>\nEmergencies \u2013 The Canadian Experience 67<br \/>\nPatient Safety \u2013 the Collaboration<br \/>\nbetween the health professions in Japan 69<br \/>\nWWMMAA<br \/>\nHow does the world treat our children? 70<br \/>\nA new online course for prison doctors 72<br \/>\nWWMMAA SSeeccrreettaarryy GGeenneerraall 74<br \/>\nWWHHOO<br \/>\nMental disorders are widespread,<br \/>\ndisabling and often go untreated 75<br \/>\nThe Health Academy: a first step<br \/>\ntowards a virtual school to<br \/>\npromote public health world-wide 76<br \/>\nThe WHO Framework Convention<br \/>\non Tobacco Control on track<br \/>\nto become law by the end of the year 77<br \/>\nMedical Plants \u2013 Guidelines To<br \/>\nPromote Patient Safety And Plant<br \/>\nConservation For A US$ 60 Billion Industry 78<br \/>\nDire Health Consequences For<br \/>\nMillions Of People In Darfur, Sudan,<br \/>\nAnd Calls For Intensified Health Response 79<br \/>\nRReeggiioonnaall aanndd NNMMAA NNeewwss 80<br \/>\nRReevviieeww 83<br \/>\n00_US_03_2004.qxd 14.09.2004 15:46 Seite 1<br \/>\nFifty Years Of Smoking Research<br \/>\nSir Richard Doll*<br \/>\nThe fiftieth anniversary of the first publication of the Journal of the World Medical<br \/>\nAssociation also saw the fiftieth anniversary of the publication of the results of an epidemi-<br \/>\nological study1<br \/>\nof the effects of something that many people at the time thought to be of<br \/>\nlittle or no international importance, but which is now beginning to equate internationally<br \/>\nwith the big three: AIDS, Malaria and Tuberculosis. The study, which was continued for<br \/>\n50 years, was the first of a series of cohort studies of the effect of smoking, and was begun<br \/>\nin October 1951 to test the validity of the conclusion that had been reached a year earlier2<br \/>\nthat cigarette smoking was \u201can important cause of carcinoma of the bronchus.\u201d<br \/>\nThis conclusion had been based on the results of personal enquiries of 709 pairs of patients<br \/>\nwith and without lung cancer and had been tentatively supported, with varying degrees of<br \/>\nstrength, by seven other studies of a similar type in Germany, the Netherlands and the<br \/>\nUSA3<br \/>\n. Few people, however, and no Government had taken the conclusion seriously. A<br \/>\nnew approach, by some different method of investigation, was evidently needed. In the UK<br \/>\nthis took the form of writing, with the help of the British Medical Association, to all doc-<br \/>\ntors resident in the country and seeking details of their smoking habits, with the intention<br \/>\nof following them for 5 years to see if knowledge of their habits would enable their risk of<br \/>\ndeveloping cancer of the lung to be predicted.<br \/>\nIn the event, replies were received from over 34 000 male and 6000 female British doctors.<br \/>\nWithin 3 years the first results confirmed the predicted relationship. When, however, five<br \/>\nyears had passed and the study was planned to stop, other diseases began to be seen to be<br \/>\nassociated with smoking and observations were continued for 50 years, before the final<br \/>\nresults of the study were published earlier this year4<br \/>\n. By then, other similar studies had<br \/>\nbeen carried out in Canada, Germany, Japan, the Netherlands, Sweden and the USA. The<br \/>\nassociations observed with some 40 diseases had, for the most part, proved to be causal,<br \/>\nand the epidemic of cigarette (or bidi) smoking, so much more hazardous than the smok-<br \/>\ning of pipes or cigars, had been shown to be a major cause of mortality in nearly all devel-<br \/>\noped countries. In the extreme case of the UK, where the prevalence of cigarette smoking<br \/>\nby young men had first became predominant, smoking was estimated to have been respon-<br \/>\nsible in the mid 1970s for as much as 25% of all deaths (in men) from all causes5<br \/>\n. For the<br \/>\nregular cigarette smoker who persisted with the habit the average loss of expectation of life<br \/>\nwas 10 years and, of course, much more for the half of them who died prematurely as a<br \/>\nresult of their habit in middle age.<br \/>\nFifty years, one might have thought, was more than enough for the lesson to have been<br \/>\nlearned and action taken internationally to counter the blandishments of the tobacco indus-<br \/>\ntry. But as smoking has been reduced in countries where the total effects first began to be<br \/>\nseen, and a substantial proportion of smokers in them had abandoned the habit, the indus-<br \/>\ntry has turned its attention more and more to the billions of men and women in the devel-<br \/>\noping countries, who have not yet had the bitter experience of seeing the worst effects<br \/>\namongst their own relatives and friends. That it will have a comparable effect in all coun-<br \/>\ntries is already clear, although the types of disease most affected will differ from country<br \/>\nto country depending on the background distribution of disease \u2013 cancer of the lung every-<br \/>\nwhere, but chronic obstructive pulmonary disease, oesophagus cancer and stroke in China<br \/>\nrather than myocardial infarction6,7<br \/>\n, and tuberculosis, most notably in some parts of India8<br \/>\n.<br \/>\nThe lessons of fifty years are not, however, all depressing; for it is now clear that stopping<br \/>\nsmoking reduces the risk and can reduce it to a very large extent. In the study of British<br \/>\ndoctors who began smoking an average of 18 cigarettes a day at a mean age of 18 years,<br \/>\nstopping around 50 years of age halved the risk, while stopping around 30 years of age<br \/>\nalmost eliminated it4<br \/>\n.<br \/>\nGuest Editorial<br \/>\n57<br \/>\nOFFICIAL JOURNAL OF<br \/>\nTHE WORLD MEDICAL<br \/>\nASSOCIATION<br \/>\nHon. Editor in Chief<br \/>\nDr. Alan J. Rowe<br \/>\nHaughley Grange, Stowmarket<br \/>\nSuffolk IP14 3QT<br \/>\nUK<br \/>\nExecutive Editor<br \/>\nDr. Ivan M. Gillibrand<br \/>\n19 Wimblehurst Court<br \/>\nAshleigh Road<br \/>\nHorsham<br \/>\nWest Sussex RH12 2AQ<br \/>\nUK<br \/>\nCo-Editor<br \/>\nProf. Dr. med. Elmar Doppelfeld<br \/>\nOttostr. 12<br \/>\nD-50859 K\u00f6ln<br \/>\nGermany<br \/>\nBusiness Managers<br \/>\nJ. F\u00fchrer, D. Weber<br \/>\n50859 K\u00f6ln<br \/>\nDieselstra\u00dfe 2<br \/>\nGermany<br \/>\nPublisher<br \/>\nTHE WORLD MEDICAL<br \/>\nASSOCIATION, INC.<br \/>\nBP 63<br \/>\n01212 Ferney-Voltaire Cedex, France<br \/>\nPublishing House<br \/>\nDeutscher \u00c4rzte-Verlag GmbH, Die-<br \/>\nselstr. 2, P. O. Box 40 02 65, 50832 K\u00f6ln\/<br \/>\nGermany, Phone (0 22 34) 70 11-0,<br \/>\nFax (0 22 34) 70 11-2 55, Postal Cheque<br \/>\nAccount: K\u00f6ln 192 50-506, Bank: Com-<br \/>\nmerzbank K\u00f6ln No. 1 500 057, Deutsche<br \/>\nApotheker- und \u00c4rztebank,<br \/>\n50670 K\u00f6ln, No. 015 13330.<br \/>\nAt present rate-card No. 3 a is valid.<br \/>\nThe magazine is published quarterly.<br \/>\nSubscriptions will be accepted by<br \/>\nDeutscher \u00c4rzte-Verlag or the World<br \/>\nMedical Association.<br \/>\nSubscription fee \u20ac 22,80 per annum (incl.<br \/>\n7 % MwSt.). For members of the World<br \/>\nMedical Association and for Associate<br \/>\nmembers the subscription fee is settled<br \/>\nby the membership or associate payment.<br \/>\nDetails of Associate Membership may be<br \/>\nfound at the World Medical Association<br \/>\nwebsite www.wma.net<br \/>\nPrinted by<br \/>\nDeutscher \u00c4rzte-Verlag<br \/>\nK\u00f6ln \u2014 Germany<br \/>\nISSN: 0049-8122<br \/>\nThe action of the World Health<br \/>\nOrganisation in seeking an International<br \/>\nagreement to discourage the spread of<br \/>\nsmoking may be thought to have been<br \/>\nunduly delayed, but it is welcome now and<br \/>\ndeserves the full support of the World<br \/>\nMedical Association.<br \/>\nAt the time of writing, this Framework<br \/>\nConvention on Tobacco Control had<br \/>\nalready been signed by 168 of the 192<br \/>\ncountries of the world and ratified by 24. It<br \/>\nbans the promotion of the use of tobacco,<br \/>\nprevents the industry from interfering in<br \/>\nany legislation to improve public health,<br \/>\nand inter alia requires the public to be fully<br \/>\ninformed about the hazards of smoking. If it<br \/>\nsucceeds it will have a major effect on mor-<br \/>\ntality in the second half of the 21st century.<br \/>\nIt will, however, be possible to diminish<br \/>\nseriously the 450 million deaths from<br \/>\nsmoking that are estimated to occur world-<br \/>\nwide in the first half of the century if pre-<br \/>\nsent smoking habits continue5<br \/>\n, only if there<br \/>\nis intensive education to persuade current<br \/>\nsmokers to stop and to provide medical help<br \/>\nfor the many who are already heavily<br \/>\naddicted.<br \/>\n1. Doll, R. and Hill, A.B. (1954) The mortality of doctors<br \/>\nin relation to their smoking habits. A preliminary report.<br \/>\nBMJ 228(i):1451-55.<br \/>\n2. Doll, R. and Hill, A.B. (1950) Smoking and carcinoma<br \/>\nof the lung. BMJ 221(ii):739.<br \/>\n3. Doll, R. (1998) Uncovering the effects of smoking: his-<br \/>\ntorical perspective. Stat Methods Med Res 7,87-117.<br \/>\n4. Doll, R., Peto, R., Boreham, J. and Sutherland, I. (2004)<br \/>\nMortality in relation to smoking 50 years observations<br \/>\non male British doctors. BMJ,320 ,1097-1102.<br \/>\n5. Peto, L., Lopez, A., Boreham, J., Thun, M., Heath, C.<br \/>\n(1994) Mortality from tobacco in developed countries:<br \/>\nindirect estimation from national vital statistics. Oxford<br \/>\nUniversity Press, Oxford.<br \/>\n6. Liu, B.Q., Peto, R., Chen Z.M., Boreham, J., Wu Y.P., Li,<br \/>\nJ.Y., Campbell .TC., Chen, J.S. (1998) Emerging hazards<br \/>\nin China: proportional mortality studies of one million<br \/>\ndeaths. Brit Med J, 317, 1411-1422.<br \/>\n7. Niu, S-R., Yang, G-H., Chen, Z-M., Wang, J-L., Wang,<br \/>\nG-H., He, X-Z., Schoepff, H., Boreham, J., Pan, H.C.,<br \/>\nPeto, R. (1998) Emerging tobacco hazards in China: 2.<br \/>\nEarly mortality results from a prospective study. Brit<br \/>\nMed J, 317, 1423-1424.<br \/>\n8. Gajalakshmi, V., Peto, R., Kanaka, T.S. and Jha, P.<br \/>\n(2003) Smoking and mortality from tuberculosis and<br \/>\nother diseases in India: retrospective study of 43,000<br \/>\nadult male deaths and 35,000 controls. Lancet 362:507-<br \/>\n15.<br \/>\n9. www.who.int\/tobacco\/fctc\/text\/final<br \/>\n* Epidemiological Studies Unit, University of Oxford,<br \/>\nHarkness Laboratory, Radcliffe Infirmary, Oxford OX2<br \/>\n6HE.<br \/>\nFinancing of every aspect of health care has<br \/>\nbeen of major concern at both national and<br \/>\ninternational levels for decades. At the<br \/>\nnational level the more developed and<br \/>\nsophisticated the society, the greater the<br \/>\npolitical problem in seeking to meet the high<br \/>\nexpectations of the population. For the<br \/>\ndeveloping countries and relevant interna-<br \/>\ntional bodies the concern is to ensure ade-<br \/>\nquate support to finance health care for the<br \/>\nmajor causes of morbidity and mortality, not<br \/>\nonly because of the threats to the individual<br \/>\ncitizen, but because of the impact of disease<br \/>\non the national economy.<br \/>\nOver the past two decades there has been a<br \/>\nmove to explore alternative methods of<br \/>\nfinance, notably the establishment of pub-<br \/>\nlic\/private financing partnerships. This<br \/>\napplies to both countries with so-called<br \/>\nnationalised health care systems such as the<br \/>\nBritish National Health Service and other<br \/>\nso-called \u201cliberal\u201d systems, in which, how-<br \/>\never, government regulation also plays a<br \/>\npart even if only by regulating the activities<br \/>\nof health care providers or insurance<br \/>\nschemes.<br \/>\nPublic\/Private initiatives have been variously<br \/>\nviewed with enthusiasm and scepticism.<br \/>\nNevertheless over the past few years there<br \/>\nhas been increasing experimentation with<br \/>\nthis concept, which has been encouraged by<br \/>\nboth the present and immediate-past Director<br \/>\nGenerals of the World Health Organisation.<br \/>\nThis is well illustrated by the Stop TB pro-<br \/>\ngramme and the HIV\/AIDS initiatives. In<br \/>\nboth cases partnerships involved both phar-<br \/>\nmaceutical and non-health related institu-<br \/>\ntions. Collaboration included both funding of<br \/>\njoint research initiatives and also facilitating<br \/>\nthe availability of measures to contain and<br \/>\nreduce the incidence of specific diseases and<br \/>\nalso to provide appropriate treatment.<br \/>\nThe recently announced potential break-<br \/>\nthrough in anti-malarial treatment promises<br \/>\nto add weight to the evidence of the value of<br \/>\npublic\/private partnerships. In the World<br \/>\nMedical Journal (WMJ(2004) 50 (2),p46),<br \/>\nreference was made to the potential value of<br \/>\nArtemisinin in the treatment of Malaria, one<br \/>\nof the three great global scourges of morbid-<br \/>\nity and mortality. In a partnership involving<br \/>\nseveral international funding sources (a non<br \/>\nprofit making organisation, a Generic drug<br \/>\nmanufacturer, scientists from various uni-<br \/>\nversities, a research Foundation and propri-<br \/>\netary drug manufacturer), research has<br \/>\ndeveloped a new drug based on the structure<br \/>\nof Artemesinin, which appears to be an even<br \/>\nmore effective anti-malarial than<br \/>\nArtemesinin itself. Furthermore, this prod-<br \/>\nuct, by avoiding the expensive and laborious<br \/>\nextraction processes involved in extracting<br \/>\nArtemesinin at present, the cost of treatment<br \/>\nis likely to be one US dollar or less. This<br \/>\nintensive research effort, made possible by<br \/>\nthe use of public\/private partnership, will no<br \/>\ndoubt encourage the use of this financing<br \/>\nmechanism for research relating to major<br \/>\ninternational diseases. It is important to note<br \/>\nthat in the context of this initiative it is<br \/>\nunderstood that any profits will be shared<br \/>\nbetween one funder and the drug manufac-<br \/>\nturer, but that the profits will be re-deployed<br \/>\nback into research. If the promise of the<br \/>\neffectiveness of the new drug is confirmed<br \/>\nin trials over the next two years, this promis-<br \/>\nes to save a million lives a year in Africa<br \/>\nalone.<br \/>\nEditorial<br \/>\n58<br \/>\nPublic \/ Private Financing and Health Research<br \/>\nClassification<br \/>\nType I diabetes1<br \/>\nis caused by an absolute<br \/>\nlack of insulin, and its treatment is based on<br \/>\ninsulin replacement. Type I diabetes repre-<br \/>\nsents 15-20 % of cases of diabetes mellitus.<br \/>\nThe peak incidence is between 10-14 years<br \/>\nof age. The incidence varies markedly from<br \/>\ncountry to country (from about 3-40 ca-<br \/>\nses\/100.000\/year) and is increasing in<br \/>\nmany countries. The average increase in<br \/>\nEuropean children under 15 years of age<br \/>\nfor example is 3-4 % each year.<br \/>\nAntigen targets for auto-immunity in pancre-<br \/>\natic \u03b2-cells (islets of Langerhans) include<br \/>\nglutanic acid decarboxylase and insulin. The-<br \/>\nre are genetic and environmental influences \u2013<br \/>\nthe major susceptibility is associated with<br \/>\nhuman leucocyte antigen (HLA) class II im-<br \/>\nmune response genes \u2013 but in more than 90<br \/>\n% of cases there is no family history of dia-<br \/>\nbetes. Likely environmental triggers for type<br \/>\nI diabetes in genetically susceptible individu-<br \/>\nals include toxins and viruses.<br \/>\nType 2 diabetes2<br \/>\n(which replaces the terms<br \/>\n\u2018non-insulin-dependent\u2019 and \u2018maturity-on-<br \/>\nset\u2019 diabetes) is the commonest form of the<br \/>\ndisease, accounting for 85-95 % of all cases<br \/>\nworldwide, and effecting 5-7 % of the worl-<br \/>\nd\u2019s population. The prevalence varies great-<br \/>\nly throughout the world from less than 1 %<br \/>\nin rural China to over 50 % in the Pima In-<br \/>\ndians of Arizona. Differences may result<br \/>\nfrom the impact of the diabetogenic Wester-<br \/>\nnised lifestyle (decrease in physical activity,<br \/>\nlack of exercise; increased energy intake<br \/>\nfrom excessive sugar, fats and \u2018junk\u2019 foods)<br \/>\non diverse genetic backgrounds \u2013 which<br \/>\nmay include \u2018Thrifty\u2019genes that in evolutio-<br \/>\nnary selection favour fat storage and\/or bu-<br \/>\nild up of insulin resistance by the tissues.<br \/>\nIt is estimated that the global prevalence of<br \/>\ntype 2 diabetes will have doubled by 2025,<br \/>\nrelative to 1995 figures, to a total of 270<br \/>\nmillion people. The greatest increases will<br \/>\nbe in the developing world, among econo-<br \/>\nmically productive adults aged 45-65<br \/>\nyears.<br \/>\nEnvironmental risks for type 2 diabetes in-<br \/>\nclude obesity (which accounts for 90 % of<br \/>\nacquired risk) and physical inactivity. Mal-<br \/>\nnutrition in utero and infancy may predis-<br \/>\npose to type 2 diabetes in adult life by \u2018pro-<br \/>\ngramming\u2019 pancreatic \u03b2-cell failure and<br \/>\nthe development of insulin resistance. Ob-<br \/>\nesity, especially with abdominal and visce-<br \/>\nral fat accumulation, induces insulin resi-<br \/>\nstance in the tissues and is associated with<br \/>\nglucose toxicity and cardiovascular risk<br \/>\nfactors such as hypertension and dyslipi-<br \/>\ndaemia. Potentially diabetogenic factors<br \/>\nproduced by adipose tissue include free<br \/>\nfatty acids, which can interfere with gluco-<br \/>\nse metabolism and therefore the action of<br \/>\ninsulin in liver and skeletal muscle.<br \/>\nClinical presentations of type 2 diabetes<br \/>\ninclude raised blood sugar, intercurrent<br \/>\nurinary or genital tract infections \u2013 and as<br \/>\nan incidental finding in 30 % of cases. In<br \/>\nthe UK fifty patients present with type 2<br \/>\ndiabetes, and a further fifty don\u2019t know<br \/>\nthey are developing the disease (which can<br \/>\ntake several years). Hyperosmolar non-ke-<br \/>\ntotic coma occurs, but ketoacidosis is rare<br \/>\nunless precipitated by severe intercurrent<br \/>\nillness, such as myocardial infarction or<br \/>\noverwhelming infections.<br \/>\nDiabetic complications such as retinopa-<br \/>\nthy, macular degeneration, nephropathy,<br \/>\nneuropathy, coronary, cerebrovascular and<br \/>\nperipheral vascular disease, in particular in<br \/>\nthe feet, are commonly found at diagnosis.<br \/>\nA new classification of diabetes was adop-<br \/>\nted in 1997 by the American Diabetes Asso-<br \/>\nciation3<br \/>\nand later in 1999 by a group of ex-<br \/>\nperts under the auspices of WHO4<br \/>\n. This was<br \/>\nbased on aetiology rather than treatment.<br \/>\nType Ia (about 90 % of type I cases in Euro-<br \/>\npe) is due to autoimmune destruction of the<br \/>\n\u03b2-cells in the islets of Langerhans, and type<br \/>\nIb where these is no evidence of autoimmu-<br \/>\nnity. Another diabetic subtype resembling<br \/>\ntype 2, but showing serological evidence of<br \/>\nautoimmunity, is referred to as latent auto-<br \/>\nimmune diabetes in adults (LADA), com-<br \/>\nprising about 10-25 % of type 2 cases.<br \/>\nThere may be other forms of insulin-defi-<br \/>\ncient diabetes. Modern techniques for hor-<br \/>\nmone and receptor characterisation, toget-<br \/>\nher with molecular genetics, show diabetes<br \/>\nto be a family of diseases. It is clear that pe-<br \/>\nople are affected by the immune process of<br \/>\nthe diabetic condition both before and be-<br \/>\nyond the stage of strict insulin dependence.<br \/>\nGenetic factors in diabetes<br \/>\nA striking feature of mature-onset diabetes<br \/>\nis the strength of its genetic component,<br \/>\nwhich is much greater than in type I diabe-<br \/>\ntes \u2013 it is estimated to account for 40-80 %<br \/>\nof total disease susceptibility. In identical<br \/>\ntwins type 2 diabetes is highly concordant<br \/>\n(60-90 %), but in non-identical twins this is<br \/>\nless so, at 17-37 %. The risk of developing<br \/>\ntype 2 diabetes increases strikingly if there<br \/>\nis a family history of the disease, especially<br \/>\namong the first-degree relatives.<br \/>\nDiabetogenic genes could influence either<br \/>\nor both of the basic defects in type 2 diabe-<br \/>\ntes, namely insulin resistance genetically<br \/>\nexpressed in the tissues or the inability of<br \/>\nthe pancreatic \u03b2-cells in the islets of Lan-<br \/>\ngerhans to secrete enough insulin. Candida-<br \/>\nte genes therefore include: (1) signalling<br \/>\nmediators and enzymes on metabolic path-<br \/>\nways (1 gene for each protein chain) that re-<br \/>\ngulate the biological actions of insulin, and<br \/>\n(2) components of the pancreatic \u03b2-cell<br \/>\nenergising secretion, together with mecha-<br \/>\nnisms that ensure \u03b2-cell survival.<br \/>\nMany studies to date have attempted to lo-<br \/>\ncate and identify genes that predispose to<br \/>\ntype 2 diabetes, such as glycogen synthase<br \/>\nThe public\/private financing mechanism is,<br \/>\nof course, also being introduced at national<br \/>\nlevels in health care services. This is sub-<br \/>\nstantially in hospital development, but it is<br \/>\nalso emerging in funding treatment centres<br \/>\nand other sectors of health care. Whilst<br \/>\nthere are marked divisions of opinion on the<br \/>\nappropriateness of the application of this<br \/>\nconcept in this context, it is still too early to<br \/>\ndetermine the outcome. One can only wait<br \/>\nand see whether a similar success in the<br \/>\ncontext of national healthcare provision<br \/>\noccurs and how it will influence the debate.<br \/>\nAlan J. Rowe<br \/>\nEditorial<br \/>\n59<br \/>\nGenetics Underlying Diabetes<br \/>\nand its tandem repeat DNA polymorphisms,<br \/>\nprotein phosphatase and its regulatory sub-<br \/>\nunits, coding regions for messenger RNA,<br \/>\nand calpain \u2013 one of the proteolytic enzy-<br \/>\nmes. It is now clear that no single major lo-<br \/>\ncus explains the inheritance of type 2 diabe-<br \/>\ntes, and the disease is caused by the interac-<br \/>\ntion of multiple genes operating in unison<br \/>\nwith environmental factors. The strongest<br \/>\nevidence to date for a type 2 diabetes<br \/>\nsusceptibility gene is for a locus designated<br \/>\n\u2018NIDDMI\u2019 on the short arm of chromosome<br \/>\n2, which accounts for as much as 30 % of<br \/>\nthe genetic susceptibility among Mexican-<br \/>\nAmerican sibling pairs.<br \/>\n\u2018Thrifty\u2019 genes<br \/>\nDuring the course of human evolution, have<br \/>\nsome genes been rendered detrimental by<br \/>\nprogressive selection? Major stressors have<br \/>\nbeen periodic food shortages, famine, and<br \/>\nthe resulting depletion of the body\u2019s energy<br \/>\nstores. Some animals may be able to cope<br \/>\nwith this by hibernating through winter but<br \/>\nin the case of humans, it was first suggested<br \/>\nby Neel5<br \/>\n(1962) that the evolutionary re-<br \/>\nsponse could have been the selection of<br \/>\n\u2018thrifty\u2019 genes which favour energy storage<br \/>\nas triglyceride in adipose tissue. Candidate<br \/>\nthrifty genes could include those involved<br \/>\nwith insulin resistance in the liver (regula-<br \/>\nting blood glucose levels) and in skeletal<br \/>\nmuscle (regulating protein synthesis). Such<br \/>\ngenes could promote substrate uptake into<br \/>\nadipose tissue. Expression of the genes<br \/>\nwould be selected in populations living in<br \/>\nextreme or precarious environments \u2013 in-<br \/>\ndeed, such a selection process would have<br \/>\noperated throughout human history.<br \/>\nSo, at the present day, humans are poorly<br \/>\nadapted from a tree-dwelling existence in<br \/>\nthe jungle to a modern environment of the<br \/>\n\u2018concrete jungle\u2019 in cities. In the 21st centu-<br \/>\nry humans are forced to adapt to the novel<br \/>\nstresses, in evolutionary terms, of overnu-<br \/>\ntrition from \u2018junk\u2019foods containing excessi-<br \/>\nve sugar, fats and salt from an early age<br \/>\n(even in utero), and lack of exercise. Such<br \/>\nfactors could explain the pandemic of ob-<br \/>\nesity in the last 20 years among societies<br \/>\nthat have adopted a Western-type lifestyle.<br \/>\nObesity<br \/>\nTotal body adiposity, a central fat distribu-<br \/>\ntion, together with a duration and time-cour-<br \/>\nse of developing obesity, are all established<br \/>\nrisk factors for clinical diabetes in both se-<br \/>\nxes. Indeed, having a body-mass index<br \/>\n(BMI) of >35 kg\/m2<br \/>\nincreases the risk of de-<br \/>\nveloping diabetes over a 10-year period by a<br \/>\nstaggering 80-fold, as compared with slim<br \/>\nindividuals with a BMI <22 kg\/m2\n. Lifestyle\nfactors such as diet and exercise account for\n90 % of this excess susceptibility to type 2\ndiabetes, of which obesity is the most impor-\ntant. Biochemical factors promoting obesity\ninclude ageing, circulating free fatty acids,\nexpressive glucose, and the action of local\nhormones in the tissues (cytokines). Genetic\ncontrol of the central metabolic pathways\ninto (a) protein synthesis, (b) free fatty acid\nutilisation from glucose via acetyl coenzy-\nme A, or (c) synthesis of cholesterol and ar-\nterial plaque, all contribute to an increasing\nprevalence of diabetes.\nIvan M. Gillibrand\nReferences\n1. G\u00e9rard Slama (2003). Chapter 3. Type I dia-\nbetes: an overview, in Textbook of diabetes\nedited by J. C. Pickup and G. Williams. 3rd edi-\ntion, Oxford, Blackwell Science Ltd.\n2. Nicholas Katsilambros and Nicholas Tento-\nlouris (2003). Chapter 4. Type 2 diabetes: an\noverview, in Textbook of diabetes, edited by J.\nC. Pickup and G. Williams. 3rd edition, Oxford,\nBlackwell Science Ltd.\n3. Report of the Expert Committee on the Diagno-\nsis and Classification of Diabetes Mellitus. Dia-\nbetes Care 1997; 20: 1183-97\n4. Alberti KGMM, Zimmet PZ, for the WHO\nConsultation. Definition, diagnosis and classifi-\ncation of diabetes mellitus and its complica-\ntions, 1: diagnosis and classification of diabetes\nmellitus-provisional report of a WHO consulta-\ntion. Diabet Med 1998; 15: 539-53.\n5. Neel JV, Diabetes mellitus: a thrifty genotype\nrendered detrimental by progress. Am J Hum\nGenet 1962; 14: 353-62.\nMedical Ethics and Human Rights\n60\nThe following article deals with a major\nissue affecting all health professionals, but\nmore notably doctors and nurses.\nUnlike many resource problems, this one\nhas major ethical and moral aspects, which\nneed to be addressed by all concerned,\nincluding the professionals, both individu-\nally and collectively.\nOrvill Adams*\nThe World Health Organization at the 57th\nWorld Health Assembly debated extensive-\nly the international migration of health per-\nsonnel.1\nThe existence of an important pub-\nlic health issue that had to be addressed was\nnever in question. How to reverse current\ntrends, and reduce adverse effects of migra-\ntion of health personnel on service delivery\n,was at the heart of the discourse.\nThe subsequent resolution recognized that\naction needed to be taken by all involved\nboth in sending and receiving countries.\nThe critical role played by health workers\nin tackling health problems, and the poten-\ntial negative impact of migration on the\ndelivery of health services is explicitly stat-\ned. Member States are urged to develop\nstrategies, frame and implement policies,\nuse government to government agreements\nand to do all of this with a view to strength-\nening health systems.\nMedical Ethics and Human Rights\nMigration of health workers:\nCritical issues in the global debate\n* Director Dpt. Health Service Provision, W.H.O.\nGeneva\nThe need to engage a large and diverse\nnumber of stakeholders in tackling the\nissues of international migration of health\nworkers is the focus of the resolution,\nwhich calls on the Director General of\nWHO to work with international organiza-\ntions to monitor the changing situation,\nconduct research, and seek options to\naddress identified problems arising from\nmigration of health personnel.\nThe debate and the resulting resolution are\nfar reaching, in that they acknowledge that\nto reverse and\/or slow down trends, it is\nnecessary to look at the workings of coun-\ntry health systems, and the labour market\nfor different types of health workers. It also\nreinforces the notion that there are fair and\nunfair practices in international recruitment\nof health personnel.\nThe Commonwealth Code of Practice for\nthe International Recruitment of Health\nWorkers is noted, and the Director General\nis requested \u201cto explore additional meas-\nures that might assist in developing fair\npractices in international recruitment of\nhealth personnel, including the feasibility,\ncost, and appropriateness of an internation-\nal instrument.\u201d Also \u201cto develop, in consul-\ntation with Member States and all relevant\npartners, including development agencies, a\ncode of practice2\non the international\nrecruitment of health personnel, especially\nfrom developing countries, and to report on\nprogress to the Fifty-eighth World Health\nAssembly.\u201d\nWhy this debate at this time\nOver the past five years there has been a\ngrowing recognition of an impending if not\nan actual crisis, in health worker migration.\nThe plight of nurses has been the primary\nfocus, and organizations such the Interna-\ntional Council of Nurses, the World Health\nOrganization, the Commonwealth Secreta-\nriat, the World Bank, the Royal College of\nNursing in the United Kingdom and others\nhave undertaken surveys and commissioned\nstudies that have described mobility trends,\nidentified \u201cpull\u201d and \u201cpush\u201d factors, and the\npolicies and strategies being used by diffe-\nrent countries.\nWhile there are significant challenges in\nmeasuring migration flows due to differ-\nences in definitions of categories of health\nworkers, in what constitutes the migration,\nand the lack of timeliness of data collec-\ntion3\n, there is growing agreement that the\ntrend is rising. Stilwell et al.4\nargue that\n\u201cThe number of people migrating has never\nbeen higher than it is now and the majority\nof migrants are highly skilled.\u201d\nFigure 1 shows that between 1992 and\n2002 the trend in health professional migra-\ntion is similar to that of other migrants to\nthe United States of America. Data for other\ncountries show similar trends. Figure 2 uses\ndata from the United Kingdom (and corrob-\norates the trend in the US) to demonstrate\nthat the trend in the movement of nurses is\nmuch more pronounced that that of physi-\ncians.\nAitken et al. refer to countries that receive\nmigrating health workers as \u201chost coun-\ntries\u201d and countries that send or export\nhealth workers as \"source countries\".\nThey recognize, however, that countries\ncan be host and source countries at the same\ntime.\nThe study examined six host countries, the\nUnited States of America, the United\nKingdom, Ireland, Canada, Australia and\nNew Zealand. They found that \u201ceach coun-\ntry's health workforce planning bodies pro-\nject a sizeable increase in national require-\nments for nurses within the decade.\u201d5\nThe\nauthors suggest that the demands of these\nsix countries are enough to deplete the sup-\nMedical Ethics and Human Rights\n61\nFig. 1 Trends\nin migration\nof profession-\nals to the U.S.\nFig. 2. Trend in migra-\ntion of physicans and\nnurses to the UK\nply of qualified nurses throughout the\ndeveloping world.\nThere has not been as much focus on the\nmigration of physicians. A study released in\n20026\nfinds that within the OECD countries\nthere is a reliance on foreign physicians.\nThe percentage of the workforce from other\ncountries, ranged from a low of 1.9% in\nAustria to 21.3% (1998) in Australia, 23%\n(2001), 25 % (1998) in Canada and 31%\n(2001) and 34.5% (2000) in the United\nKingdom and New Zealand respectively.\nThe OECD conducted a case study of inter-\nnational mobility of health workers from\nSouth Africa. The study found that in the\nyear 2001, 23,407 South African-born\nworkers were practising a medical profes-\nsion in the five OECD countries shown in\nTable 1. The report states that South African\nhealth workers are appreciated for their pro-\nfessional and language skills.\nA recent report by Physicians for Human\nRights states that \u201cBy one measure, about\n50% of graduate physicians emigrate with-\nin 4.5 years and 75% within 9.5 years.\nFurther, during the 1990s, 1,200 physicians\nwere trained in Zimbabwe; only 360 were\nstill practising in the country in 2001\u201d.7\nEthiopia is said to have lost one third of its\nphysicians during the period 1988 to 2001.\nInternal migration\nInternational migration compounds internal\nmigration from the public to the private sec-\ntor. The Report of the Physicians for\nHuman Rights above states that \u201cZambia's\npublic sector has retained only 50 of the\n600 physicians that have been trained in the\ncountry\u2019s medical school from approxi-\nmately 1978 to 1999\u201d.8\nAwases et al9\nin a\nstudy of migration of health professionals\nin the six African countries of Cameroon,\nGhana, Senegal, South Africa, Uganda and\nZimbabwe found that internal migration is\na large and growing problem for the public\nhealth sector.\nThis concern is highlighted by the follow-\ning example from South Africa \u201cIn 1998,\n52.7% of all general practitioners and 76%\nof all specialists worked in the South\nAfrican private health sector. By 1999, 73%\nof general practitioners were estimated to\nbe working in the private sector in South\nAfrica, despite the fact that this sector\ncatered for less than 20% of the popula-\ntion\u201d.10\nThe movement from the private to\nthe public sector is often accompanied by\nmovement from the rural to urban areas,\nresulting in increased inequities in the\ndelivery of health services.\nFactors affecting the move-\nment of health workers\nThe migration of health workers is affect-\ned by personal and external or environ-\nmental factors. These include political and\nsocio-economic differences between\ncountries, as well as formal and informal\ninformation networks for migrants and\nprospective migrants. Authors 11,12,13\nhave\nidentified \u201cpull\u201d and \u201cpush\u201d factors. Poor\nworking conditions, low wages, economic\ninstability, health and safety concerns are\nsome of the \"push\" factors. Opportunities\nto earn higher wages, to have better work-\ning conditions, access to education and\ncareer advancement, are among the \u201cpull\u201d\nfactors. These factors are interrelated and\nwill take on different degrees of impor-\ntance in the decision of the prospective\nmigrant depending on age, economic and\nsocial position in their country.\nIt is important to note that the relative\nimportance of the \"push and pull\" factors\ndiffer across countries. An unpublished\nWHO African Regional Office study of\nsix countries found that health workers,\nwhen asked if they had an intention to\nmigrate, responded with the proportions\nof those saying yes ranging from 26% in\nUganda to 68% in Zimbabwe. The four\nMedical Ethics and Human Rights\n62\nTable 1. Number of South African-born workers practising a medical profession in certain OECD member countries in 2001\n1. Doctors, dentists, veterinarians and other diagnostic practitioners.\n2. Including assistants.\n3. Possibly including some assistant nurses.\nSource: OECD, Trends in International Migration- ISBN 92-64-01944-8\nCountries Practitioners (1) Nurses and midwives\nOther health\nprofessionals (2)\nTotal\nAustralia 1114 1085 1297 3496\nCanada 1345 330 685 2360\nNew Zealand 555 423 618 1596\nUnited Kingdom 3282 2923 (3) 2451 8999\nUnited States 2282 2083 2591 6956\nTotal 8921 6844 7642 23 407\ntop factors affecting their decisions were\ntheir expectations for better management\nof health services, continuing education\nand training opportunities, conducive\nworking environment and better and real-\nistic remuneration for their work.\nProspective migrants from Ghana gave\nmore weight, for example, to better man-\nagement of health services and to a con-\nducive working environment than did\nhealth workers interviewed in the other\ncountries.\nEthical recruitment\nAggressive recruitment of health workers\nhas attracted a lot of international atten-\ntion and some of the practices have been\nviewed as unethical and unfair. This\nnotion of unethical and unfair includes the\nimpact of the practices on the individual\nhealth worker as well as their impact on\nthe health systems from which the health\nworker is recruited. The ICN describes\naggressive recruitment campaigns as\n\u201cfocussing on large numbers of recruits,\nsometimes significantly depleting a given\nhealth facility or contracting an important\nnumber of newly graduated nurses from a\ngiven educational institute\u2026. Nurses may\nbe employed under false pretences or mis-\nled as to the conditions of work and possi-\nble remuneration and benefits.\u201d14\nThe aggressive recruitment of health\nworkers from vulnerable health systems\nhas resulted in a call for ethical recruit-\nment practices. These practices are volun-\ntary and have not yet proven to be very\neffective. The codes can be put into three\ncategories based on the source of their\ndevelopment. In the first, the Department\nof Health in England has developed two\ninstruments, one in 1999 and the other in\n2001. The codes are aimed at protecting\nvulnerable developing countries from the\nrecruitment of nurses unless there is an\nagreement between England and the\nrespective country. Ireland developed a\nsimilar instrument in 2001.\nThe second category is that of multiple\ngovernments. The Commonwealth code\nof practice for international recruitment of\nhealth professionals was developed by the\nCommonwealth Secretariat at the instiga-\ntion of the member countries.\nIn the third category are non-governmen-\ntal membership organizations The In-\nternational Council of Nurses, the World\nOrganization of National Colleges,\nAcademies and Academic Associations of\nGeneral Practitioners\/Family Physicians,\nthe Royal College of Nursing in England,\nand a group of independent sector\nemployers have also developed and adopt-\ned statements that can be said to be in sup-\nport of ethical recruitment practices.\nWillett and Martineau, after conducting\nan analysis of the above instruments, con-\ncluded that \u201cit is currently far from clear\nwhether codes of practice or other such\ninstruments \u2013 on ethical international\nrecruitment of health professionals-will\nactually succeed in protecting developing\ncountries health systems.\u201d15\nThe authors\ncall for more focus on the ethical recruit-\nment objective of existing or new codes.\nImproved data collection systems on\ninternational recruitment to facilitate\nmonitoring of the implementation of the\ncodes and more sustained external pres-\nsure to apply the code are also required.\nConclusion\nThe recruitment, retention and migration\nof health workers requires concerted\nefforts by a mix of nationally based and\ninternational stakeholders. The factors\ndetermining why health workers choose to\nmove or stay are complex. There are no\nsimple solutions. More evidence is needed\nand this requires the active and willing\nparticipation of governments, employers\nand professional bodies at national and\ninternational levels. Health systems have\nto be strengthened to provide better condi-\ntions and opportunities to practice one\u2019s\ncareer while getting fulfilment from being\nable to practice one\u2019s profession. All\ninterested parties-, governmental, non-\ngovernmental, health care providing agen-\ncies and the health care professionals\nthemselves \u2013 will have to address the\nmoral and ethical issues underlying the\nproblems of recruitment and migration.\n1 World Health Organization, WHA57.\n19, Agenda item 12.11, International\nmigration of health personnel: a chal-\nlenge for health systems in develop-\ning countries, May 2004.\n2 The meeting accepted that within the\nUnited Nations system, the expres-\nsion \"code of practice\" refers to in-\nstruments that are not legally binding.\n3 Diallo K, Data on the migration of\nhealth-care workers: sources, uses,\nand challenges, Bulletin of the World\nHealth Organization, August 2004,\n82(8)\n4 Stilwell B, Diallo K, Zurn P, Vujicic\nM, Adams O, Dal Poz M. Migration\nof health-care workers from Develop-\ning countries: strategic approaches to\nits management. Bulletin of the World\nHealth Organization, august 2004,\n82 (8)\n5 Aitken H, Buchan J, Sochalski J,\nNichols B, Powell M. Trends in Inter-\nnational Nurse Migration. Health Af-\nfairs, Volume 23, no.3 2004.\n6 Bourassa-Forcier M, Giuffrida A. In-\nternational Migration of Physician\nand Nurses: Causes, Consequences\nand Health Policy Implications. Orga-\nnization for Economic Co-operation\nand Development, Human Resources\nfor Health Care OECD Project. 2002\n7 Physicians for Human Rights. An Ac-\ntion Plan To Prevent Brain Drain:\nBuilding Equitable Health Systems in\nAfrica. June 2004. Boston\n8 Physicians for Human Rights. An Ac-\ntion Plan To Prevent Brain Drain:\nBuilding Equitable Health Systems in\nAfrica. June 2004. Boston\n9 Awases M, Nyoni J, Gbary A, Chatora\nR. Migration of Health Professionals\nin Six Countries: A Synthesis Report.\nWorld Health Organization, WHO\nRegional Office for Africa, April\n2003 (Draft report \u2013 Unpublished).\n10 Padarath A, Chamberlain C, McCoy\nD, Ntuli A, Rowson M, Loewenson R.\nHealth Personnel in Southern Africa:\nConfronting misdistribution and brain\ndrain. EQUINET Discussion Paper\nno. 4, 2003\nMedical Ethics and Human Rights\n63\nBiomedical research as part of science has\n,since the end of the 2nd World War, tradi-\ntionally been performed in an international\ncontext, which includes exchange of\nresults, errors and benefits. Some aspects of\nthis scientific sector are subject to some\nregulation by specific provisions within\nlegislation covering broader frameworks,\nsuch as those covering the use of personal\ndata for medical epidemiological research.\nFor decades there have been no internation-\nal legally binding instruments covering the\nentire area of biomedical research on\nhumans. Nevertheless, most medical\nresearchers followed the Declaration of\nHelsinki (1964) as amended in Tokyo 1975\nand subsequent later amendments.(3) The\nInternational Ethical Guidelines of CIOMS\nplayed a similar role addressing researchers\nin medicine and other disciplines (5).\nResearch is becoming more and more com-\nplex with respect to the aims, the methods\nused, and involving researchers coming\nfrom both medical and non-medical scien-\ntific disciplines. Research entails the risk of\nviolations of human rights and basic ethical\nprinciples. Therefore States are more and\nmore disposed to regulate this sector by\nnational legislation and no longer leave it to\nprofessional standards established by the\nprofessions and codes of ethics alone. This\nnew thinking was in part prompted by the\ndevelopments in in-vitro-fertilisation tech-\nniques. Taking into account these and other\ndevelopments in biology and medicine, the\nCouncil of Europe decided to establish a\nspecial Steering Committee on Bioethics\n(CDBI), for consideration of ethical and\nlegal questions linked to these new research\npractices and their application in humans.\nAs a result, one remarks more and more\nnational and international efforts to imple-\nment legally binding instruments regulating\nresearch on humans. Regarding the trans-\nborder flow of research, it has been recog-\nnised that there is a need to base national\nlegislation on international legal provisions.\nThe following two examples illustrate the\nimportance of these developments to the\nmedical profession, its national and its\ninternational organisations.\nDirective 2001\/20\/EC\nIn 2001 the European Union adopted the\n\u201cDirective 2001\/20\/EC\u201d (4) on good clini-\ncal practice in research on drugs for human\nuse within Member States. In implementing\nthe provisions of this directive in national\nlegislation (which was required at the latest\nby 1st of May 2004), Member States are\nallowed to deviate to some extent if the\nintentions of this European law are not\naltered. The directive covers the whole field\nof drug research in the course of which it\nalso introduces changes in the meaning of\nsome terms used by the medical profession\nin this field. In contrast to the traditional\nunderstanding, the directive defines (Art.2)\n\u201csponsor\u201d as an \u201cindividual, company,\ninstitution or organisation which takes\nresponsibility for the initiation, manage-\nment and\/or financing of a clinical trial.\u201d\nThe sponsor, understood in that sense e.g.\nas interpreted by the new German drug law\nof 5 August 2004, has in addition to other\nobligations, to negotiate with the ethics\ncommittees and the competent national\nauthority. Members of the medical profes-\nsion are no longer the only partners of an\nethics committee established at their med-\nical association or their Faculty of Medicine.\nThis is also introduced in the new definition\nof an investigator. In future, the function of\nan investigator or of a principal investigator\nin drug research is no longer restricted to\nphysicians. The directive definition states\n\u201cinvestigator\u201d: a doctor or a person follow-\ning a profession agreed in the Member\nStates, for investigations because of the sci-\nentific background and the experience in\npatient care it requires.\u201d The Member States\nas already mentioned, have some freedom of\ninterpretation. The new German drug legis-\nlation uses this right by prescribing that an\ninvestigator, a principal investigator or a co-\nordinating investigator should be a duly\nqualified physician. Any exception to this\nbasic principle has to be justified to the\nethics committee.\nThe status and the rights of ethics commit-\ntees are widened. The directive obliges the\nMember States to establish a system of\nethics committees (Art 6), leaving all spe-\ncific details to national law. Germany decid-\ned to maintain the well proven system of\nethics committees in the Faculties of\nMedicine and the Medical Associations\nwithin the States (\u201cBundesl\u00e4nder\u201d). In the\nfuture, drug research on humans may only\nbe started following the favourable opinion\nof an ethics committee and \u201cinasmuch as the\ncompetent authority of the Member State\nconcerned has not informed the sponsor of any\ngrounds of non-acceptance\u201d (Art. 9). In this\n11 Stilwell B, Diallo K, Zurn P, Vujicic M,\nAdams O, Dal Poz M. Migration of\nhealth-care workers from Developing\ncountries: strategic approaches to\nits management. Bulletin of the World\nHealth Organization, august 2004,\n82 (8)\n12 Aitken H, Buchan J, Sochalski J,\nNichols B, Powell M. Trends in Inter-\nnational Nurse Migration. Health\nAffairs , Volume 23, no.3 2004.\n13 Padarath A, Chamberlain C, McCoy D,\nNtuli A, Rowson M, Loewenson R.\nHealth Personnel in Southern Africa:\nConfronting misdistribution and brain\ndrain. EQUINET Discussion Paper\nno. 4, 2003\n14 International Council of Nurses. Ca-\nreer Moves and Migration: Critical\nQuestions. Geneva, 2003.\n15 Willetts A, Martineau T. Ethical Re-\ncruitment of health professionals: Will\ncodes of practice protect developing\ncountry health systems? Liverpool\nSchool of tropical medicine, 2004.\nMedical Ethics and Human Rights\n64\nBiomedical Research In Europe\nNew International Legal Instruments\nElmar Doppelfeld\nway, in incorporating the provisions of the\ndirective into the new German drug law, the\nvote of an ethics committees has changed its\ncharacter from that of advice to the\nresearcher to a legally binding decision.\nFearing for good reasons some kind of liabil-\nity coming from this new status of the vote,\nMedical Associations in Germany discussed\nrefusing the duty to maintain their ethics\ncommittees for the new purpose imposed by\nthe Federal Drug Legislation, although tech-\nnically these professional bodies and institu-\ntions are bound by Lande law.\nThere are a number of other implications for\nchange in carrying out drug research in this\nEU Directive. These cannot be outlined in\nthis short communication which only aims\nto highlight key issues. The directive calls\nfor detailed study and, bearing in mind the\nglobal nature of drug research,will merit stu-\ndy by the relevant sector of the profession\noutside Europe.\nProtocol \u201cBiomedical\nResearch\u201d of the Council\nof Europe\nThe \u201cConvention on Human Rights and\nBiomedicine\u201d(2) of the Council of Europe,\nopened for signature in Oviedo on 4 April\n1997 and has been signed by more than 30\nand ratified by 18 Member States. It outlines\nthe basic principles for the protection of\nhuman rights and dignity with regard to the\napplication of biology and medicine in\nhumans. This convention, also known as\n\u201cConvention of Oviedo\u201d permits regulation\nin special fields such as organ transplanta-\ntion or biomedical research in human in\nadditional protocols in accordance with the\nprinciples of the convention itself. Only\nStates which have signed and ratified the\nconvention are admitted to sign and to rati-\nfy these additional protocols. By signing\nand ratifying the Convention and additional\nprotocols, Member States implement these\ninternational treaties into their national leg-\nislation, normally giving them by this proce-\ndure a high position in the internal hierarchy\nof legal provisions.\nOn 30 June 2004 the Committee of\nMinisters of the Council of Europe adopted\nthe additional protocol concerning biomed-\nical research (1). It is planned to open it for\nsignature on 18 October 2004 in Oslo. This\nprotocol respecting the principles laid down\nin the Convention of Oviedo addresses med-\nical as well as non medical researchers, who\ncarry out biomedical research in humans. As\nthere is no restriction of this type of research\nto physicians, the term \u201cphysician\u201d or the\nterm \u201cdoctor\u201d does not appear.\nThe protocol covers various types of\nresearch. Research on healthy volunteers\nwithout a potential direct benefit for the per-\nson concerned and aimed to achieve basic\nknowledge, e.g. in human physiology, is\nincluded, as well as research linked to clini-\ncal care. Attention is given to special condi-\ntions such as pregnancy, or the situation of\npersons deprived of liberty. Research on the\nlatter group is in some Member States of the\nCouncil of Europe permitted, in others it is\nstrictly prohibited. This situation shows the\ndifficulty, as in many other fields, to find a\nlegal solution which satisfies all the differ-\nent views. Usually such problems are left to\nnational legislation. The additional protocol\nsets the conditions under which such a dero-\ngation can be used.\nResearch with potential direct benefit for the\nperson concerned in emergency situations\nand on persons not able to consent is widely\naccepted and is also addressed in the proto-\ncol. In contrast, research on persons not able\nto consent \u2013 e.g. minors, victims of traffic\ninjuries, persons suffering from dementia\nsuch as Alzheimers disease \u2013 without the\npotential direct benefit for the participant\nconcerned but with an expected benefit for\nthe group, entails major legal problems in\nsome Member States. The protocol requires\nthat the State concerned should provide a\nlegal clarification of the conditions to be\nrespected for that research, in first line: min-\nimal risk and minimal burden. Leaving the\nspecial legal position of ethics committees\nto the internal legislation of the Member\nStates, the protocol prescribes precisely how\nto fulfil the basic condition of informed con-\nsent of participants in research and the\nduties of representatives of persons not able\nto consent. There are precisely elaborated\nchapters on how to inform the participants\nand how to inform the ethics committees.\nThe list of items to be used for the applica-\ntion to seek an ethics committee's assess-\nment should serve as a tool for the harmon-\nisation of research in humans in the Member\nStates of the Council of Europe.\nIn addition to the scientific quality of the pro-\nject, legal aspects and ethical considerations,\nthe ethics committee has for example to\nknow something on contracts between\nresearchers and participants, financial remu-\nneration or other awards for both parties, how\nto offer to the individual findings relevant for\nhis or her health, publication of results and\nsafeguarding that any necessary healthcare is\nnot delayed for research reasons. The proto-\ncol allows the use of placebo only under the\nclassic conditions: no methods of proven\neffectiveness exist or the withdrawal or with-\nholding of such methods does not present an\nunacceptable risk or burden. In contrast to the\nDeclaration of Helsinki 2000, scientific rea-\nsons as such are not accepted as justification\nfor the use of placebo.\nIt should be stressed that the protection of the\nrights of the participants is the leading aim of\nthe protocol, in the same way providing the\nnecessary framework for research of a high\nscientific level in accordance with accepted\nprinciples of ethics and human rights.\nDetails of that new international legal provi-\nsion can be found in the text itself.\nFinal considerations\nThe new international legal instruments for\nbiomedical research in humans as a basis\nfor legislation in the Member States of the\nEU and in the 45 Member States of the\nCouncil of Europe, (representing about 800\nmillions of habitants) will replace as tools\nof first legal choice traditional and without\nany doubt, proven regulations coming from\nother groups such as the World Medical\nAssociation or Medical Associations in the\nStates concerned. In any case of conflict,\nthe national or international legal provi-\nsions prevail over regulations coming from\na non-legal source. In a State which, for\nexample, has adopted the additional proto-\ncol on biomedical research, the use of\n65\nMedical Ethics and Human Rights\n66\nplacebo is only permitted under the condi-\ntions of that protocol. A physician who fol-\nlows the wider provisions of the\nDeclaration of Helsinki, using placebos\nalso for scientific reasons as the only justi-\nfication, could be found guilty by a court.\nOn the other hand, if non-legal provisions\ngive a range more narrow as compared to\nthe research protocol, the researcher may\nalways decide to stick to legal provisions as\njustification.\nNevertheless, the recommendations of the\nNGOs mentioned will not become worth-\nless in the future. Legislation may adopt\nthem as an auxiliary tool for regulation\ninasmuch they are in accordance with\nnational and international legally binding\ninstruments. They may as recommenda-\ntions or principles given by the profession\nbe of assistance, for example to physicians,\nin deciding whether or not to perform\nresearch under the legal conditions of the\ncountry in which they are living. Members\nof the profession should respect these rec-\nommendations and principles in decision\nmaking, but they must follow the legal\nframe given for research.\nLiterature\n1. Additional Protocol to the Convention on\nHuman Rights and Biomedicine concerning\nBiomedical Research, Strasbourg, 30 June\n2004, European Treaty Series \u2013\nNo\u2026\u2026..Provisional Edition\n2. Convention for the Protection of Human\nRights and Dignity of the Human Being\nwith regard to the Application of Biology\nand Medicine: Convention on Human\nRights and Biomedicine, Oviedo, 4. IV.\n1997. In: European Treaty Series \u2013 No. 164,\nCouncil of Europe, Strasbourg\n3. Declaration of Helsinki, see different\nissues at The World Medical Association\nInc., www.wma.net\n4. Directive 2001\/20\/EC of the European\nParliament and of the Council of 4 April\n2001 on the approximation of the laws, reg-\nulations and administrative provisions of the\nMember States relating to the implementa-\ntion of good clinical practice in the conduct\nof clinical trials on medicinal products for\nhuman use; Official Journal of the European\nCommunities, L 121\/34 \u2013 44, 1.5.2001\n5. International Ethical Guidelines for\nBiomedical Research Involving Human\nSubjects, CIOMS, Geneva 2002\nProf. Elmar Doppelfeld MD\nChairman of the Permanent Working\nGroup of Scientific Ethics Committees\nin Germany\nDieselstra\u00dfe 2\nD-50859 K\u00f6ln\ne-mail: med.ethik.komm@netcologne.de\nFollowing a recent decision of the Board of\nthe Norwegian Medical Association, the\nPresident, Dr. Hans Kristian Bakkem, has\nwritten in the following terms to all nation-\nal medical associations seeking their sup-\nport in actions to ensure the full implemen-\ntation of the UN Minimum Rules for the\nTreatment of Prisoners.\n\u201cWith reference to recent disclosure of\nepisodes of torture and other degrading\ntreatment of prisoners in Iraqi prisons:\nRecalling UN Standard Minimum Rules for\nthe Treatment of Prisoners which state:\n\u201cAt every institution there shall be avail-\nable the services of at least one qualified\nmedical officer who should have some\nknowledge of psychiatry. The medical ser-\nvices should be organised in close relation-\nship to the general health administration of\nthe community or nation. They shall\ninclude a psychiatric service for the diagno-\nsis and, in proper cases, the treatment of\nstates of mental abnormality.\u201d The\nNorwegian Medical Association (NMA) is\nconcerned about prisoners' health not only\nin Iraq but also in other countries, where\ninternational regulations are being violated.\nThe Norwegian Medical Association would\nemphasise physicians' ethical obligation to\nspeak out against torture and\/or other\ndegrading treatment in prisons, whenever\ndisclosed.\nGovernments, as well as penal authorities\nshould accept physicians\u2019obligations in this\nrespect. They should also inform and\nencourage their physicians to speak out\nregarding inhuman and\/or other degrading\ntreatment.\nThe Norwegian Medical Association\nencourages all National Medical\nAssociations to call upon their governments\nto organise prison health care according to\nthe international regulations mentioned\nabove.\u201d [June 2004]\nMedical Ethics and Human Rights\nMedical Ethics and Human Rights\nUN Standard Minimum Rules for the Treatment of Prisoners\nHenry Haddad, MD, FRCPC, Professor of\nMedicine, University of Sherbrooke,\nQuebec; Jill Skinner, RN, BA(Hons),\nSenior Project Manager, Canadian\nMedical Association; Dr. Isra Levy, MB,\nBCh, MSc, FRCPC, Chief Medical Officer\n&#038; Director, Office of Public Health\nCanadian Medical Association\nIntroduction\nIn a world that seems characterized by an\nincreasing number of natural disasters, ter-\nrorist threats and an array of new diseases\nthat can travel around the globe at jet speed,\nall nations, now more than ever before,\nneed to be adequately prepared to respond\nto an emergency situation. During a large-\nscale health emergency such as an emerg-\ning infectious disease outbreak, while pub-\nlic health is often the first line of defense\nthe resources of the entire health system\nwill be called upon to respond to the crisis.\nIn 2003 both the resources and the\nresourcefulness of Canada\u2019s public and\nacute care health systems were put to the\ntest when Severe Acute Respiratory\nSyndrome (SARS) entered the country.\nWhile SARS brought out the best in\nCanadians' commitment to one another, it\nalso turned a bright, sometimes uncomfort-\nable spotlight on the ability of Canada's\nhealth care system to respond to a crisis.\nDuring the SARS crisis, the critical role\nplayed by physicians and their professional\nassociations quickly became apparent. This\npaper will briefly review the course and\nimpact of SARS in Canada; outline the role\nof the Canadian MedicalAssociation (CMA)\nduring and after the crisis; review the evolu-\ntion of public health policy in Canada post-\nSARS; and reflect on the role of the World\nMedical Association (WMA) in preparing\nfor future health emergencies. A companion\narticle that addresses the role of the CMA\nand lessons learned during the SARS out-\nbreak can be found in Business Briefings:\nGlobal Healthcare \u2013 Advanced Medical\nTechnologies 2004, prepared for the WMAi\n.\nThe Course of SARS\nin Canada\nOn February 23, 2003 SARS entered\nCanada. In the manner of many emerging\ninfectious diseases it entered quietly and\ninitially went unrecognized. Canada's first\nSARS death occurred before the WHO\nissued its initial global alert on March 12th.\nBy the time Canada's SARS outbreak was\ndeclared over at the beginning of July 2003,\n44 people had died. Overall 438 SARS\ncases, 251 probable and 187 suspect, were\nreported in Canada during the period of the\noutbreak and tens of thousands of individu-\nals, including hundreds of health care work-\ners, were quarantined.\nThe entire health system, from preventive\npublic health through acute care to long-\nterm care, was severely disrupted in\nToronto, one of Canada's most populated\nand medically advanced cities. Local public\nhealth authorities in the Greater Toronto\nArea (GTA) as well as their provincial\ncounterparts, diverted almost all of their\nresources to respond to the crisis. Many\npublic health professionals from outside the\nGTA volunteered weeks of service to assist\nin the response, sometimes leaving local\npublic health units elsewhere in the country\nwith significant human resource gaps in\ntheir own ongoing programs.\nAcute care services were also adversely\naffected as stringent infection-control and\nscreening measures were put into place to\ncontrol the spread of SARS. Institutions\nclosed their doors, limiting access to emer-\ngency departments, clinics and physicians'\noffices. Intensive care units were full and\nsurgeries were cancelled. Front-line health\ncare professionals involved in critical care\nwere stretched to their physical and mental\nlimits. Remarkably, others found them-\nselves underutilized due to the impact of the\ninfection-control measures on their practice\nsettings. \u201cFeast and famine\u201c co-existed.\nAlthough the GTA bore the brunt of the\nimpact of SARS, the entire province of\nOntario and indeed all of Canada was\naffected. Business suffered. The tourism\nindustry was severely impacted. The dis-\nruption that SARS caused continues to\nreverberate through the health care systems\nand economies of Canada.\nThe Role of the Canadian\nMedical Association\nFront line physicians played a critical role\nin the health emergency, both in terms of\nthe public health and laboratory response,\nand in their community and institutional\nacute care roles. During the outbreak physi-\ncians were engaged in identifying and\ntracking down the emergence, cause and\nmodes of transmission of a new disease,\nand caring for patients in an environment of\nshifting and evolving clinical knowledge.\nThey collaborated with researchers and sci-\nentists to determine optimum therapy and\nclinical best practice guidelines. And\nthrough all of this clinicians dealt with the\npersonal stress, anxiety and burnout associ-\nated with a desperate race to control and\ncontain the unknown, in a context of human\nresources inadequate to function optimally\neven in normal circumstances.\nThe CMA's primary goal was to support\nphysicians during the crisis. It became appar-\nent very early in the outbreak that govern-\nments did not have the ability to communi-\ncate in real time with front line clinicians\nacross the country. CMA and its provincial\ncounterpart, the Ontario Medical Association\n(OMA) moved quickly to plug this gap.\nCMA activated its national electronic com-\nmunication networks to alert physicians to\ncrucial information such as public health\nmanagement guidelines, about SARS. A\ndedicated website, e-mail and fax broad-\ncasts to physicians, coupled with the sup-\nport and assistance of provincial divisions\nand national speciality affiliates, meant that\nover 90% of physicians in Canada had\naccess to relevant expert information about\nSARS as it became available. The OMA\nwas critical to ensuring the flow of informa-\ntion to clinicians in Ontario, Canada\u2019s most\naffected province. The association used its\nweb site, fax and e-mail networks as well as\n67\nMedical Science, Professional Practice and Education\nMedical Associations and Global Health\nEmergencies \u2013 The Canadian Experience\npersonal telephone calls when necessary to\nensure that clinicians received pertinent\ninformation that was clear, consistent, and\nrelevant. During the early days of the out-\nbreak the OMA communicated with its\nmembership every 24 to 48 hours and its\nweb site was updated frequently.\nThroughout the crisis, the CMA maintained\nclose liaison with Health Canada, federal,\nprovincial and territorial public health\nauthorities and relevant national medical\norganizations, notably the Canadian\nInfectious Disease Society and the\nCanadian Association of Emergency\nPhysicians. The CMA also co-ordinated\nregular meetings of non-physician national\nhealth professional organizations, including\nthe Canadian Nurses Association and the\nCanadian Public Health Association, to\nfacilitate rapid information-sharing among\nall health care providers.\nFacilitating communications, reviewing\ninformation, and providing the clinician\nperspective on government directives\nbecame a key activity for medical associa-\ntions during the SARS outbreak. The CMA\nalso ensured that the physicians' voice was\nheard at Federal decision-making tables\nduring the crisis. It must be noted that while\ngovernments eventually welcomed this\nassistance, the valuable role that profes-\nsional associations can play during a crisis\nhad not been considered in their emergency\nplanning and was not uniformly embraced\nor recognized as the outbreak unfolded.\nEvolution of Canadian Public\nHealth Policy Post SARS\nAs the crisis subsided, a number of nation-\nal and provincial committees were set up to\nexamine the country's response to SARS. In\nJune 2003, Answering the Wake-Up Call:\nCMA's Public Health Action Planii\nwas sub-\nmitted to the National Advisory Committee\non SARS and Public Health (Naylor\nCommittee) established by the Federal\nMinister of Health to report on learnings\nfrom the SARS outbreak. The CMA has a\nlong tradition of participating in the devel-\nopment of health policy in Canada. It has\nalways been a very vocal advocate for a\nstrong and effective health system and had\nrepeatedly called for governments to\nenhance public health capacity and\nstrengthen the public health infrastructure.\nThe CMA's action plan focused on three\nkey areas: legislative reform, capacity\nenhancement and communications. Key\nrecommendations included:\n\u2022 A national public health agency led by a\nchief public health officer\n\u2022 Increased funding to strengthen the pub-\nlic health infrastructure and increase\ncapacity\n\u2022 A real-time communication and coordi-\nnation initiative for front line clinicians.\nSimilar recommendations were also made\nin the CMA submissioniii\nto the Canadian\nSenate Standing Committee on Social\nAffairs, Science and Technology's (Kirby\nCommittee) study of the governance and\ninfrastructure of the public health system in\nCanada and its response during public\nhealth emergencies.\nSARS was indeed a wake up call to the dete-\nriorating condition of Canada's public health\nsystem and to the country's ability to respond\nto a health emergency from a health care sys-\ntem perspective. Both national and provin-\ncial inquiries pointed out many systemic\ndeficiencies in the response to SARS. Lack\nof surge capacity in the clinical and public\nhealth systems; difficulties with timely infor-\nmation sharing among levels of government;\nlack of co-ordinated business processes\nacross institutions and jurisdictions for out-\nbreak management and emergency response;\ninadequacies in institutional outbreak man-\nagement protocols, infection control, and\ninfectious disease surveillance; and weak\nlinks between public health and the personal\nhealth services system, including primary\ncare, institutions, and home care were some\nof the problems cited.iv\nThere has been a consistency in the recom-\nmendations of the main inquiries into the\nimpact of SARS on the health care system\nand these recommendations reflect those\nmade by the CMA. All inquiries have\nstressed the need for a coordinated collabora-\ntive framework among different levels of\ngovernment. This coordination of activity\nshould be integral to the core functions of\npublic health and is essential to an effective\nresponse during times of crisis. The rules for\na seamless public health system must be sort-\ned out in advance of a health emergency in a\nspirit of partnership and shared commitment\nto health. Both the Naylor and Kirby reports\ncalled for the establishment of a national pub-\nlic health agency in Canada with authority to\nprovide leadership and action on public\nhealth matters such as national disease out-\nbreaks and emergencies. It was further rec-\nommended that a Chief Public Health Officer\nof Canada head up the Agency and serve as\nthe national voice for public health particu-\nlarly during health emergencies.\nThe need for new funding to shore up the\npublic health infrastructure in Canada was\nalso widely recognized. In addition, the\nimportance of disease surveillance and dis-\nsemination of information to clinical and\npublic health information systems and rele-\nvant stakeholders was raised in provincial\nand national reports.\nGovernments wasted no time in responding\nto the lessons learned from SARS. In\nSeptember 2003 the Canadian Conference\nof Federal\/Provincial\/Territorial Ministers\nof Health acknowledged the need to work\ntogether to improve public health infrastruc-\nture, and increase institutional, provincial,\nterritorial and federal capacity. They also\nagreed to work collaboratively on such\nissues as clarifying roles and responsibilities\nof the differing jurisdictions when respond-\ning to public health threats; ensuring the\nadequacy of health human resources;\nstrengthening capacity to respond to region-\nal and national public health emergencies;\nand enhancing national surveillance and\ninformation infrastructure.v\nIn the fall of 2003 the federal government\naccepted many of the recommendations of\nthe Naylor report and appointed the first\never Minister of State for Public Health. It\ncommitted itself to the establishment of a\nnational public health agency and a chief\npublic health officer. The 2004 Federal bud-\nget directed new investment to public health\nin Canada. Details of the new Public Health\nAgency for Canada were announced in May\n2004 as was the creation of six National\nCollaborating Centres for Public Health.\n68\nMedical Science, Professional Practice and Education\nWhile SARS in Canada was an undeniably\ntragic chapter in Canada\u2019s history it did\nserve to bring attention to the plight of the\npublic health system and has spurred the\nfederal and provincial governments to\nstrengthen public health systems and capac-\nity to be better prepared in the future.\nThe lessons learned from SARS in Canada\nand the steps being taken to improve the\npublic health system and its emergency pre-\nparedness and response capabilities may be\nof value to others as they assess their own\nstate of readiness.\nWorld Medical Association\nThe World Medical Association has recog-\nnized the critical role of physicians during a\nhealth emergency. Physicians are often the\nfirst point of contact with the emergence of\nnew diseases, and therefore are in a position\nto aid in all elements of diagnosis, treat-\nment of affected patients and prevention of\ndisease. At its September 2003 General\nAssembly, the WMA adopted a Resolution\non SARS that: \u201cstrongly encouraged the\nWorld Health Organisation to enhance its\nemergency response protocol to provide for\nthe early, ongoing and meaningful engage-\nment and involvement of the medical com-\nmunity globally.\u201c\nIn the aftermath of SARS, the WMA and\nthe CMA have worked closely together to\nexamine the lessons learnt for physicians\nand medical associations. A discussion\npaper, SARS in Canada,vi\ninformed the\ndeliberations of the WMA Socio-Medical\nAffairs Committee on implications of the\nSARS experience for physicians in Canada.\nKey among them is the need for:\n\u2022 a co-ordinated system to notify acute\ncare facilities and front line health care\nprofessionals of global health alerts and\nensure real time communication of crit-\nical information to physicians;\n\u2022 cross training to boost surge capacity by\nequipping health professionals with the\nknowledge and skills that can be called\nupon in times of health emergency;\n\u2022 rapid distribution of supplies of protec-\ntive equipment to health professionals\nand their patients to reduce anxiety and\nthe spread of infectious disease\n\u2022 the incorporation of physicians with key\nexpertise into the health emergency\ndecision-making process so that the\nimpact of directives on clinical settings\nand patient care is understood.\nThese implications apply, in general terms,\nin all countries of the world, no matter the\ntype, structure or capacity of the health care\nsystem.\nIn May 2004 the WMA Council adopted a\nresolution on health emergency communi-\ncation and co-ordination which includes\nrecommendations for physicians, national\nmedical associations, national governments\nand the WHO. The resolution seeks to\nimprove physician reporting of suspicious\nillness; disaster preparedness and response\nprotocols for infectious disease outbreaks;\ncoordination of stockpiles of supplies; and\ninternational co-operation on emergency\ncommunication.\nConclusion\nA dispassionate assessment of the experi-\nence with the SARS outbreak of 2003 clear-\nly indicates that the global medical commu-\nnity and the global public health communi-\nty must strive to build mechanisms togeth-\ner, and also with governments, to closely\nlink the clinical, public health and govern-\nment responses to emerging infectious dis-\neases, and bridge communications between\nthese communities.\nThe WMA will seek, in partnership with the\nWHO and others, to develop a Health\nInformation Communication initiative that\nmeaningfully does just this, both in times of\nglobal health emergencies, and also in\ntimes of routine health system operations.\ni Avaliable at:\nhttp:\/\/www.touchbriefings.com\/cdps\/cditem.cfm?NID=95\n0&#038;CID=5&#038;CFID=1688258&#038;CFTOKEN=90\nii (Available on the CMA website http:\/\/www.cma.ca\/index.\ncfm\/ci_id\/3429\/la_id\/1.htm;\niii Available on the CMA website at http:\/\/www.cma.ca\/\nindex.cfm\/ci_id\/40463\/la_id\/1.htm\niv Learning from SARS: Renewal of Public Health in\nCanada; A Report of the National Advisory Committee\non SARS and Public Health, Health Canada, October\n2003; http:\/\/www.hc\u2013sc.gc.ca\/english\/protection\/warn-\nings\/sars\/ learning.html\nv News Release, Conference of\nFederal\/Provincial\/Territorial Ministers of Health,\nHalifax, Nova Scotia - September 4, 2003, http:\/\/www.hc-\nsc.gc.ca\/english\/media\/releases\/ 2003\/2003_67.htm\nvi Available on the WMA website at\nhttps:\/\/www.wma.net\/e\/pdf\/sars_discussion_paper.pdf\n69\nMedical Science, Professional Practice and Education\nDr. Harauo Uematsu\nPresident, Japan Medical Association\n(based on a presentation at the WHPA,\nGeneva 2004)\nPeople in Japan especially health profes-\nsionals, have been sorely troubled by the\ninability to come up with effective mea-\nsures to curb the increasing number of med-\nical errors in this country. Although statis-\ntics on all medical errors that have occurred\nin Japan have not been compiled, the num-\nber of civil cases in this area has doubled\nduring the past decade from 442 incidents\nin 1993 to 896 in 2002. The increase in the\noverall number of errors cannot be debated\nif it is focused only on the number of civil\nsuits, but it is a reality that national public\ninterest has become focused on reducing\nthe number of medical errors.\nSeveral extremely serious medical errors\nhave been widely reported in Japan in\nrecent years, notably medication and\ndosage mistakes, patient mix-ups, inade-\nquately trained physicians conducting unfa-\nmiliar surgical operations, and other errors\nstemming from negligence of basic precau-\nPatient Safety \u2013 the collaboration between the\nhealth professions in Japan\ntionary measures that have caused patient\ndeaths and other serious consequences. The\nmajority of those involved have been\nindicted as criminal case defendants. Many\nof these errors have occurred at large uni-\nversity and major city hospitals that are\nequipped with the latest equipment and\nfacilities and where there is a team of physi-\ncians, nurses, pharmacists and other health\npersonnel working conjointly. The main\ncause of medical errors at these hospitals\nappears to be a lack of communication and\nmisinformation.\nIn the wake of a medical error stemming\nfrom a patient mix-up involving a medical\nteam at a major university hospital in\nJanuary 1999, the Ministry of Health,\nLabour and Welfare created a committee of\nspecialists to review measures aimed at pre-\nventing the reoccurrence of medical errors.\nIn March 2000, the MHLW organized a\nliaison meeting of representatives from\nmedical associations, pharmacist associa-\ntions, nurses associations, hospital associa-\ntions, and other health organizations aimed\nat raising the awareness about the impor-\ntance of all health-related organizations to\nimplement patient safety protection coun-\ntermeasures.\nPrior to this, the JMA had established its\nown committee on medical safety counter-\nmeasures in 1997 with the goal of creating\na framework for medical error prevention\ncountermeasures. This committee consisted\nof JMA members, members from the Japan\nPharmaceutical Association and the\nJapanese Nursing Association to ensure the\nparticipation of not only physicians but also\nhealth professions representing all aspects\nof the health care sector in providing rec-\nommendations on how to improve patient\nsafety. According to the committee's 1998\nreport, the major factor in preventing med-\nical errors and realizing patient safety was\nto create an atmosphere at the health care\nsite where all health professions could\nfreely voice their opinions and hold con-\nstructive discussions outside the confines of\nestablished authority. To achieve this\nchange in awareness successfully, upper\nmanagement and the physicians themselves\nmust take the initiative in promoting this\nchange.\nPresently, many hospitals in Japan have\nestablished committees consisted of a vari-\nety of professions dedicated to preventing\nmedical errors. They are responsible for\ndiscussing and recommending measures to\nprevent the reoccurrence of actual medical\nerrors as well as compiling reports on errors\nthat did not harm patients. What is impor-\ntant about these measures is not the quanti-\nty of data collected for x-number of cases,\nbut rather how many errors were prevented\nas a result of the lessons that were learned\nfrom past experiences. It is the health pro-\nfessions from all walks of the health sector\nthat are in direct contact with the problems\nat the actual health site who can identify\ntruly beneficial information from the\nlessons that are extracted from the enor-\nmous amount of data that is available.\nIn addition to medical associations, each\nhealth organization has conducted signifi-\ncant recommendations and activities to\nrealize patient safety in medicine. For\nexample, the Japan Pharmaceutical\nAssociation has focused its efforts on pre-\nventing errors related to dispensing drug\nprescriptions and the Japanese Nursing\nAssociation has published accident preven-\ntion guidelines. Needless to say, health care\nactivities are not carried out by one health\nprofession. They requires the mutual col-\nlaboration of all health professions. Patient\nsafety countermeasures require the collec-\ntive effort of the entire health care team and\nthey must be based on shared knowledge\nand an awareness that go beyond the con-\nfines of each profession.\nMembers of a health care team are col-\nleagues that have been brought together by\na mutual goal \u2013 the task of saving the life of\na patient. Therefore, they must engage in\nwholehearted discussions, mutually assist\neach other and collectively face the many\ndangers that threaten the safety of patients.\n70\nWMA\nPresentation given by Dr. Appleyard,\nPresident of the World Medical\nAssociation, to the Scientific Conference\nof the Dominican Medical &#038; Dental\nSociety 16 July 2004\nViolence is a leading public health problem.\nAs a profession we need to have a fundamen-\ntal re-think of the role we physicians can play\nboth to mitigate the effects of the current epi-\ndemic of violence and to develop strategies to\nprevent violence in the longer term.\nThe World Medical Association was found-\ned after the turbulence, terror and torture of\nWorld War II in 1947, to unite physicians\nworldwide in a shared mission founded on\ntraditional Hippocratic principles. These\nhave been enshrined in the Declaration of\nGeneva, which commits members of the\nprofession to \u201cconsecrate their lives in the\nservice of humanity and that the health of\neach patient will be their first considera-\ntion\u201d. Further work on repairing the dam-\nage resulting from some doctors' conduct\nduring that War was undertaken to establish\nthe Declaration of Helsinki which defines\nthe ethical principles underlying clinical\nresearch. Later, after wide consultation, the\nDeclaration of Tokyo was forged which\nstates that doctors \u201cshall not countenance,\ncondone or participate in the practice of tor-\nture or other forms of cruel, inhuman or\ndegrading procedures.\u201d More recently, the\nDeclaration of Ottawa on the Right of a\nChild to Health Care encouraged physicians\nto \u201ceradicate all forms of child abuse\u201d.\nAfter the end of the \u2018Cold War\u2019, a \u2018peace\ndividend\u2019 never materialized. Expenditure\non arms decreased in the early 1990s, but\nthe savings were not allocated to children\u2019s\nneeds. A decade of ethnic conflict and civil\nwars ensued, characterised by deliberate\nviolence against children on a vast scale.\nChildren have become targets as well as\nperpetrators of violence, perpetuating the\nHow does the world treat our children?\nViolence and child health\nWMA\ncycle of violence into the next generation.\nDuring these conflicts, children have been\nmaimed, killed, uprooted from their homes,\norphaned, exploited and sexually abused.\nThey have been abducted and recruited as\nsoldiers. During conflict, a country's food\nproduction is compromised, malnutrition\nensues with a life-long effect, and with the\ndisintegration of the local 'infrastructure'\nhealth services disappear and mortality\nrates rise. These are clearly reflected in\nUNICEF league tables of under-5 mortality\nrates per 1,000 live births. Those countries\nriven by conflict and thrown into poverty\nhave the highest rates of childhood mortal-\nity. An enormous sacrifice, which those\ncountries cannot afford to bear.\nAn estimated 300,000 children are actively\ninvolved in armed conflicts. AIDS follows\nin the wake of such conflicts, leaving large\nnumbers of orphans and by killing teachers,\nhealth workers and public servants under-\nmines the stability of the country.\nImmunization programmes disintegrate,\nleaving a further burden of disability and\ndeath for the poorer countries to bear. Thus,\nAngola has the highest polio infection rate\nin all Africa and the Democratic Republic\nof the Congo has had a ten-fold increase in\npolio since 1999.\nThe epidemic of violence perpetuates\npoverty giving a further twist to the vicious\ncycle of poverty, poor health and death to\nmore poverty, more ill health and more\ndeaths.\nViolence becomes endemic in communities\nand is continued in such institutionalised\ncultural practices as female genital mutila-\ntion affecting 2 million children and women\nworldwide. Rape and domestic violence\nalso cause a 5% loss of healthy life years.\n\u201cThe 20th century was one of the most vio-\nlent periods in human history. An estimated\n191 million people lost their lives directly\nor indirectly, as a result of armed conflict\nand well over half were civilians\u201d (Rummel\nR J 1994). The risk factors are well known.\n\u2022 Lack of the democratic process and\ndenial of the rights of the individual\n\u2022 Social inequity with unequal access to\nwealth and health\n\u2022 Control of natural resources by a single\ngroup\n\u2022 Rapid demographic change (Carnegie\nCommission)\nTo prevent violence nations must;\n- reduce poverty and ensure that develop-\nmental assistance in the form of social\nand health care reaches those who need\nit\n- reduce inequity\n- reduce access to arms\n- abide by international treaties.\nPhysicians are very much involved in the\nfirst action and by their example will\nencourage others to seek the 2nd, 3rd, and\n4th.\nThe costs of violence have been calculated\nin Latin America. It costs Colombia and El\nSalvador 25% of their gross national bud-\ngets, Brazil and Venezuela about 11% and\nMexico 1.3%\nIf those countries are to emerge from pover-\nty, their internal conflicts must cease\nthrough the example of their neighbours.\nWe can do more to undo the harm of terror\nand torture which are the hallmarks of the\noppressive regime, by exposing the practice\nof torture. Physicians are in a dangerous but\ncrucial position to identify the victims and\ndocument their injuries so that the perpetra-\ntors can be brought to justice.\nIt is a gradual process. Torture is undertak-\nen in intense secrecy, though it instills fear\nfrom the knowledge that it is taking place.\nOnce brought to the light of day with the\nnaming and shaming of the perpetrators, the\nwill of the people will prevail. That is why\nthe WMA is partnering in the International\nCouncil for the Rehabilitation of Torture\nVictims in pilot projects in five countries to\npromote the Istanbul Protocol, which pro-\nvides guidance on the identification of the\ninjuries of torture victims so that they can\nbe documented and the perpetrators\nbrought to justice.\nIn my view, as a profession we need to do\nmore. We must also tackle the root causes\nof child abuse, instill in societies non-vio-\nlent means of resolving disputes, and we\nmust start in childhood.\nThe chastisement of children promotes a\nculture of violence; this is exacerbated by\nthe severer forms of child abuse. Idi Amin\nwas a prime example of how devastating\nthe long term consequences can be.\nI smacked my own children on a very few\noccasions. Each time it was a failure by\nme as their father to manage an annoying\nprovocative act. No one can be perfect,\nbut we can change our way of thinking\nand learn nurturing ways of bringing up\nour children. The case against chastising\nchildren is overwhelming. Under UK law,\nreasonable chastisement is allowed. Not\nto allow chastisement is more reasonable.\nLike the introduction of seat belts in the\nUK, change of behaviour comes over\ntime. The important message is that the\ncommunity agrees that it does not con-\ndone violence towards children or adults.\nIn this way communities and the world\nwill be much safer places for their chil-\ndren and the future of the world.\nDr James Appleyard\n71\nWMA\nUNICEF in highlighting the plight of\nthousands of children abducted by the\nrebel Lord's Resistance Army in Nor-\nthern Uganda has said that the plight of\nthese children as child soldiers and sex\nslaves is being forgotten. UNICEF\nExecutive Director Carol Bellamy is\nquoted as saying, \u201cThe world may be\nawakening to the emergency in Sudan,\nbut it has all but forgotten the tragedy of\nneighbouring Uganda, where in the past\ntwo years some 12,000 boys and girls\nhave been abducted by the LRA\u201d (UN\nOffice for the Coordination of\nHumanitarian Affairs, 27 July 2004).\n72\nDr. Bj\u00f8rn Oscar Hoftvedt, Head of\nDepartment of Professional Affairs,\nNorwegian Medical Association\nIntroduction\nMedical services in prison should be avail-\nable to prisoners and organised to the same\nquality and standards available to persons\nin the community at large. A prison doctor\nis responsible for the prisoners' physical\nand mental health, and if necessary a pris-\noner should have access to specialised\nhealth care outside the custodial setting.\nThe doctor's duty to secure that the prison-\ner receives appropriate health care can,\nhowever, come into conflict with the inter-\nests of the prison administration. Referring\na patient to a specialist service can be\nexpensive, particularly when the patient\nneeds a guard or other security measures 24\nhours a day. For economical reasons many\nprison directors could try to put pressure on\nthe doctor to refrain from referring patients\nto clinics outside the prison.\nPrison doctors can be called upon to exam-\nine whether a prisoner is fit for isolation or\nother forms of special punishment. They\ncan also be ordered to give medical treat-\nment to prisoners who have been tortured.\nSituations like these can cause difficult\ndilemmas for the doctor. On the one hand,\nhe\/she should comply with the same ethical\nrules and human rights standards that are\napplicable to all patients outside the prison.\nOn the other hand, the prison doctor is a\npart of the correctional system. Regardless\nof the organisational structure, it can be dif-\nficult to defend the rights of the prisoners.\nThe prison doctors therefore should have the\nknowledge and skills needed to identify situ-\nations where they are in danger of violating\nmedical ethics and human rights, and how\nthey should deal with such situations.\nEducational programmes on ethics and\nhuman rights for prison doctors are not,\nhowever a priority in most countries. The\nNorwegian Medical Association, in co-oper-\nation with the World Medical Association,\nhas therefore developed an Internet course\non ethics and human rights for doctors and\nother health personnel working in prisons.\nStructure of the course\nThe course is interactive, using cases and\nreal-life material on which the student can\nreflect. Each module ends with a multiple\nchoice test and there are also exercises and\nopen questions on which the doctor is\nrequired to comment. When the doctor has\nfinished all the modules and completed the\ntests and the evaluations, he can receive a\ndiploma and earn 12 hours\/points in post-\ngraduate and continuing education.\nAccreditation\nThe Norwegian Medical Association has\naccredited the course, but we have also\napplied for accreditation from the European\nAccreditation Council for Continuing\nMedical Education. The course is free of\ncharge. The World Medical Association is\nthe main distributor of the programme.\nHow to access the course\nThe course can be accessed via the World\nMedical Association's website: www.wma.\nnet or directly on http:\/\/lupin-nma.net.\nThose wishing to get an impression of the\ncourse can log on as a guest.\nDoctors and others who wish to take the\ncourse must register and are required to\nanswer all the exercises and tests and com-\nplete the evaluation form which appears at\nthe end of each module.\nContent\nThe course consists of twelve modules:\n1. International statements on human\nrights, medical ethics and international\nhumanitarian law\nJim Welsh, Amnesty International, London,\nUK.\nThis module discusses the general princi-\nples underlying the body of law and ethics\nrelevant to the work of prison doctors and\nhow it can assist doctors in structuring\ntheir work with prisoners. The module\nalso outlines the main differences between\nhuman rights standards, medical ethics\nand humanitarian law.\n2. Patient confidentiality and informed con-\nsent\nAnn Sommerville, Head of Ethics, British\nMedical Association, Visiting Professor of\nMedical Ethics, Queen Mary College,\nUniversity of London.\nRegardless of where they are employed,\ndoctors have ethical duties to treat all\npatients with respect. Seeking patient con-\nsent and co-operation is part of this.\nPrisoners are entitled to the same respect as\nother patients, from the time of their admis-\nsion and throughout their period of\ndetention.\nHaving completed this module, the doctor\nshould understand when consent is needed\nfrom prisoners as from other patients, have\nknowledge of the prisoners' right to confi-\ndentiality, be able to assess when non-med-\nical staff have a right to look at prisoners'\nmedical records, and identify situations in\nwhich doctors can breach confidentiality.\n3. The prison doctor's responsibility to\nreport abuses of human rights\nJim Welsh, Amnesty International, London,\nUK.\nIncarceration and lack of power, as well as\nprisoners' relative deprivation, contribute to\nmaking them vulnerable to abuses. They\nrepresent a population whose rights are\nWMA\nIn WMJ50(1) we published a preliminary note that a course on Ethics and Human Rights for\nPrison Doctors was being developed by the Norwegian Medical Association and the WMA.\nThis course is now accessible on the WMA website and his article sets out in some detail the\nmotivation for the course, its content and how doctors can participate.\nA new online course for prison doctors\ninherently at risk - from staff, from other\ninmates and from the prison environment.\nThis chapter focuses on situations in which\ndoctors are obliged to take action and what\nactions are possible. It also suggests\nsources of support and cites standards\nwhich can be used to support action.\n4. Dual loyalties\nBj\u00f8rn Oscar Hoftvedt MD, The Norwegian\nMedical Association, and Hernan Reyes,\nMedical Division, International Committee\nof the Red Cross.\nThe interests of the penitentiary or correc-\ntional system are clearly security and con-\ntrol, and not primarily the prisoners' health.\nIn many prison systems, doctors are obliged\nby the prison rules to see every prisoner\nbefore he or she can be punished for break-\ning some prison rule and sent to the punish-\nment cell. Should the doctor declare a pris-\noner as fit for punishment, or monitor pris-\noners in solitary confinement fit for the con-\ntinuation of the punishment? There are often\nno clear solutions to such dilemmas. After\ncompleting this module the doctor should be\nable to identify situations where medical\nindependence can be violated and be\nacquainted with international codes and de-\nclarations that ensure medical independence.\n5. Hunger strike\nHernan Reyes, Medical Division,\nInternational Committee of the Red Cross.\nA hunger strike is a way of fasting that\ninvolves some form of protest. It is usually\nundertaken by prisoners or other persons in\na custodial setting. There are different types\nof hunger strikes, some of which involve\ncomplex situations and conflicts. Prison\ndoctors need to know about the clinical sit-\nuations and physiology of fasting, but also\nhave to be aware of the ethical issues at\nstake. This chapter discusses these issues\nand presents the medical and ethical guide-\nlines relating to hunger strikes of which all\ndoctors should be aware.\nThe module concentrates on the definitions\nof hunger strike and how to analyse the\nhunger striker's motives. The doctor should\nbe acquainted with Ethies and human rights\nthe doctor's role and be able to counsel a per-\nson on a hunger strike.\n6. Health services for female prisoners\nIngrid Lycke Ellingsen, Member Committee\nfor Prevention of Torture, Council of\nEurope.\nFemale prisoners serve their sentences\nunder the same conditions as men, enjoy\nthe same rights and incur the same obliga-\ntions. They belong, however, to the catego-\nry of especially vulnerable prisoners - a fact\nwhich poses challenges for prison manage-\nment as well as for health care personnel\nworking in the prisons.\nThe main points in this module are the\ninternational instruments which give the\ndoctor authority within the prison context\nto seek ways to protect female prisoners. It\nalso deals with signs to look for which may\nindicate the specific problems women will\nexperience in a prison setting, the impor-\ntance of clinical assessment on admission\nand during imprisonment and appropriate\nmanagement and treatment proposals.\n7. Health care for vulnerable groups\nRosemary Wool, International Council for\nPrison Medical Services.\nThe very nature of imprisonment inevitably\nincreases the vulnerability of any person\nentering prison custody. There is no way to\nescape the close proximity of fellow prison-\ners or the culture of the prison community,\nwhich has its own hierarchical structures\nand its own value system. Within the prison\ncommunity there are some groups of pris-\noners (adolescents, HIV-infected, homosex-\nuals, etc.) who are particularly vulnerable to\nphysical and\/or mental abuse.\nBy the end of this module the prison doctor\nwill have learnt the important role of the\ndoctor in the management of vulnerable\nprisoners, the main vulnerability factors of\neach category of prisoner mentioned, and\nways of reducing the risk of physical and\nmental harm and deterioration of health.\n8. Care of the mentally ill in prison\nDusica Lecic-Tosevski, MD, Professor of\nPsychiatry, Institute of Mental Health\nSchool of Medicine, University of Belgrade\nSerbia and Montenegro, and Vladimir\nJovic, MD, Psychiatrist and Psycho-\ntherapist, Psychiatric Service \"Median\",\nBelgrade, Serbia and Montenegro.\nThe high level of psychiatric morbidity in\nthe prison population means that doctors\nproviding health care within prisons come\ninto frequent contact with mental health\nproblems, often of considerable severity. In\nmost respects, care of the mentally ill in\nprisons is no different from such care in\nother areas of the mental health services.\nHowever, it does differ in some ways. It\noccurs in an environment of compulsion\nand coercion. The modern concept of men-\ntal health care focuses on therapy and reha-\nbilitation rather than control and contain-\nment. This is not easy to achieve in prisons,\nwhere dual loyalties and responsibilities are\ndominant. There is no doubt, however, that\ndoctors should consider the care of mental-\nly disordered offenders as their primary\nfunction. The goals to reduce symptoms\nand improve function are not in conflict\nwith prevention of recidivism (social func-\ntion). Prevention and rehabilitation of men-\ntal disorders should not be neglected in\nprison settings.\n9. Violence in Prisons: The Role of the\nMedical Professional\nJames McManus, Professor of Criminal\nJustice at Glasgow Caledonian University.\nViolence is endemic in prisons. Indeed, the\nvery act of depriving someone of his or her\nliberty is an act of violence, but one which\nalmost all societies accept as legitimate in\ncertain circumstances. Not surprisingly,\nhowever, the generally accepted legitimacy\nof imprisonment does not in itself always\nprevent the inherent violence of the act\nfrom setting a general tone of violence in\npenal institutions.\nIn this module the prison doctor will be able\nto understand the different kinds of vio-\nlence which can arise in this arena, develop\nstrategies for medical responses to each of\nthe categories of violence in prisons, and\nconsider his\/her contribution to strategies\nfor violence reduction.\n10. Medical signs of torture and other\ndegrading treatment\nSverre Varvin, PhD, Senior Consultant\nPsychiatrist, Researcher, National\n73\nWMA\nAs the WMA approaches its 55th General\nAssembly, scheduled to take place in Tokyo\nduring October 2004, the organization cele-\nbrates its long and fruitful partnership with\nthe Japan Medical Association. This associ-\nation joined the WMA in its early years and\never since has made a formidable contribu-\ntion in every sense of the word. Not only\nhave the physicians from Japan been able to\nhelp build cultural bridges between other\nnations and Japan, but they have also man-\naged to produce great leaders. The leg-\nendary Dr. Takeo Takemi was a hugely\ninfluential leader in Japan and one of the\ntrusted advisers of the Emperor of Japan.\nHe also served as the President of the\nWMA and managed to make a great impact\non how the medical profession and its ethi-\ncal codes evolved. Another JMA leader\nwho made a huge contribution to interna-\ntional medicine was Dr. Eitaka Tsuboi.\nDuring his reign as JMA President, he man-\naged to help defend the profession's clinical\nautonomy and ethics in a time of rapid\nchange and globalization. As WMA\nPresident, he represented the organization\nwith great honour throughout the world,\nincluding cross-sectoral interchanges such\nas the World Economic Forum in Davos.\nDuring 2004, another great leader emerged\nwhen Dr. Harano Uematsu, long-time\nPresident of the Osaka Medical Asso-\nciation, was elected as the new JMA\nPresident. He will be welcoming some 200\nmedical leaders from all over the world to\nTokyo this October. As two organizations\nwith an ever-growing influence, the WMA\nand JMA will facilitate the international\ndebate on a wide-ranging spectrum of\nissues, from the ethics of research to the\nmanagement of human resources for health.\nIn addition, the JMA was one of the initia-\ntors of the policy debate on the link between\nwater resources and public health, and the\nWMA will most probably adopt its first pol-\nicy statement on the important links between\nwater and health. It will again be a privilege\nto welcome the Emperor and Empress as\nwell as the Prime Minister of Japan to the\nGeneral Assembly, a great honour for all the\ninternational participants present.\nTokyo was the site where one of the land-\nmark policies of the WMA, the famous\nDeclaration of Tokyo, was adopted. In\n1975, the WMA General Assembly devel-\noped and adopted this Declaration to pro-\nvide guidelines for physicians to detect,\ntreat and help prevent the torture and abuse\nof detainees or prisoners. The importance\nof this policy document has always been\nvalued by partners such as the Red Cross,\nwho perform prison visits throughout the\nworld and know how vulnerable prisoners\nare to torture and abuse. But in the last few\nmonths, with much being written in the\npress about the possible involvement of\nphysicians in the torture and abuse of\ndetainees in different countries, the impact\n74\nWMA Secretary General\nKnowledge Centre for Trauma and\nViolence, University of Oslo, and \u00d6nder\nOzkalipci, MD, Human Rights Foundation\nof Turkey.\nTrauma affects the mind and body and\ngives symptoms and signs that originate in\na disturbance in the mind-body organisa-\ntion. Mental trauma is an experience of\noverwhelming fear and helplessness.\nHabitual ways of coping break down, and\nthe person must use desperate and primitive\nmeans to survive, both mentally and physi-\ncally. Repeated or prolonged traumatic\nexperiences strain the capacities, exhaust\nthe individual and commonly may lead to\nsevere and prolonged after-effects.\nAfter going through this section the learner\nshould understand and be able to diagnose\npsychic trauma and set up a treatment plan\nfor the traumatised person.\n11. Research involving members of the\nprison population\nJulian Sheather, Ethics Adviser, British\nMedical Association.\nAs a general principle, prison inmates\nhave exactly the same rights to consent\nand to refuse involvement in research\nprojects as the general population.\nPrisoners are also entitled to benefit from\nresearch and innovative treatment in the\nsame way as individuals in the communi-\nty. They have the right to act altruistical-\nly through involvement in research pro-\njects which, while carrying only minimal\nrisk, might benefit others in the same cat-\negory without directly benefiting them-\nselves.\nThis module particularly explores what\nrights prisoners have to consent or refuse\ninvolvement in research programmes, and\nto what extent, if any, these differ from the\nrights of the general population; how to\nassess the various ethical considerations\nthat apply when designing research using\nprison populations; and the factors that\nneed to be taken into account when assess-\ning the fairness of procedures for recruiting\nprison participants into research pro-\ngrammes.\n12. Capital punishment\nVivienne Nathanson, MD, Director of\nProfessional Activities at the British\nMedical Association, Professor, School of\nHealth, University of Durham.\nCapital punishment has been removed from\nthe statute books in many countries. Of\nthose that retain it within their legislative\nframework, only a minority continue to use\nit. A very small number of countries use\ncapital punishment extensively. The pur-\npose of this section is not to consider the\nmoral and ethical issues covering its avail-\nability and appropriateness as a sanction,\nbut the issues that surround its use, and in\nparticular the roles that may be played by\ndoctors.\nDoctors working in prisons should be able\nto identify the areas in which they might be\nasked to become involved, and the ethical\ndilemmas relating to treatment decisions.\nCapital punishment is not a uniform sys-\ntem, and the dilemmas will therefore differ,\ndepending upon the legislation.\nFrom the Secretary General\u2019s Desk,\nAugust 2004\n75\nand importance of this policy has been\nemphasized even more. The Declaration\nstates in no uncertain terms that physicians\nshould in no way facilitate, condone or par-\nticipate in the practice of torture or other\nforms of cruel, inhuman and degrading pro-\ncedures of prisoners and detainees. This\nethical obligation applies to all physicians\nin all situations, including armed conflict\nand strife. It is evident that physicians\nworking in prisons have a greater challenge\nto deal with these realities, and for this rea-\nson the WMA, in collaboration with the\nNorwegian Medical Association, have\ndeveloped a training manual to help bolster\nknowledge of the subject of the prevention\nof torture and abuse. This distance learning\ncourse will be launched during September\n2004 and will hopefully provide a much -\nneeded resource for prison personnel\nworld-wide.\nLastly, the General Assembly in Tokyo will\nmark the change of guard of the WMA\nPresidency. Dr. Jim Appleyard, a paediatri-\ncian and seasoned medical politician from\nBritain, will hand over the reins to Dr. Yank\nCoble, a Past President of the American\nMedical Association. Dr. Appleyard has\nserved the WMA and the medical profes-\nsion with great distinction. His Presidential\ntheme, the protection and development of\nchildren's rights to health care, was timely,\nappropriate and well received both by\nmembers and world bodies such as the\nWorld Health Organization. His successor,\nDr. Coble, plans to launch a \"Caring\nPhysicians\" campaign during his term. As\nthe classic example of a caring physician\nhimself, he will visit the six regions of the\nWMA promoting and highlighting the fun-\ndamental values of medicine - science, care\nand ethics. For the first time, the President\nwill have his own website and end the year\nwith the publication of a book depicting\nrole model physicians from all over the\nworld. Truly an Assembly and Presidency\nto look forward to.\nGeneva \u2013 Up to half of all people with seri-\nous mental disorders in the United States\nand several European Countries are not\nreceiving treatment, and the situation is\neven worse in some developing countries,\naccording to major studies by the World\nHealth Organization.\nThe findings from the first of a series of\nWHO World Mental Health Surveys are\npublished in the current issue of the Journal\nof the American Medical Association\n(JAMA)1\n. They clearly show the high\nprevalence and burden of mental disorders\nglobally which, despite available treat-\nments, remain largely untreated.\nThe first WHO World Mental Health\nSurvey report includes data from 14 coun-\ntries (six less developed, eight developed)\non the prevalence, severity, and treatment\nof mental disorders from 60,463 face-to-\nface interviews with adult individuals rep-\nresenting the general population. The\nSurveys were conducted from 2001\u20132003\nin the Americas (Colombia, Mexico, United\nStates), Europe (Belgium, France,\nGermany, Italy, Netherlands, Spain,\nUkraine), the Middle East and Africa\n(Lebanon, Nigeria), and Asia (Japan,\nseparate surveys in Beijing and Shanghai in\nthe People's Republic of China). The six\ncountries classified as less developed by\nthe World Bank are China, Colombia,\nLebanon, Mexico, Nigeria, and Ukraine.\nAll surveys used a structured diagnostic\ninterview to assess disorders and treatment.\nDisorders considered included anxiety dis-\norders, mood disorders, disorders that share\na feature of problems with impulse control,\nand substance abuse disorders.\nThe researchers found that the prevalence\nof having any mental disorders in the prior\nyear varied widely from 4.3% in Shanghai\nto 26.4% in the United States.\n\u201cBetween 33.1% (Colombia) and 80.9%\n(Nigeria) of 12-month cases were mild,\u201d\nthe researchers report. \u201cSerious disorders\nwere associated with substantial role dis-\nability [inability to carry out usual activi-\nties] 35.5% to 50.3% of serious cases in\ndeveloped countries and 76.3% to 85.4% in\nless-developed countries received no treat-\nment in the 12 months before the inter-\nview.\u201d\n\u201cThe fact that many people with subthresh-\nold disorders are treated while many with\nserious disorders are not shows that unmet\nneed for treatment among serious cases is\nnot merely a matter of limited treatment\nresources, but that misallocation of treat-\nment resources is also involved\u201d, the\nauthors, Drs Ronald C. Kessler and T.\nBedirhan Ust\u00fcn on behalf of the 28 country\nnetwork, concluded.\n\u201cTo the extent that early intervention can\nprevent progression, early treatment might\nbe cost effective. A new focus on develop-\nment and evaluation of secondary preven-\ntion programs for the early treatment of\nmild cases is needed to guide rationaliza-\ntion of treatment resource allocation,\u201d the\nauthors conclude.\nDr. Benadetto Saraceno, Director of the\nWHO Department of Mental Health and\nSubstance Abuse, commended the study as\n\u201cconclusive evidence on indicating the\nglobal burden of disease due to mental and\nsubstance abuse disorders\u201d and \u201cgood\ninsight into the treatment gap that exists all\nover the world largely because of stigma\nand under-recognition of mental and sub-\nstance abuse disorders.\u201d\n1. JAMA 2004; 291: 2581-2590. Available at\nwww.jama.ama-assn.org\/cgi\/reprint\/291\/21\/2581.\nPlease see Jama paper for list of authors and for fund-\ning information.\nWorld Health Organization\nMental and substance abuse disorders\nMental disorders are widespread,\ndisabling and often go untreated\nPhilippe Stroot, WHO Geneva\nThe Health Academy is a WHO initiative to\ncreate a global health and technology net-\nwork. Its uniqueness lies in its capacity to\nprovides health information to the general\npublic for the purpose of health improve-\nment. It provides guidance in terms easily\nunderstood by people from all walks of life\nand all age groups, taking into considera-\ntion their individual cultural sensitivities.\nHealth is a universal value that transcends\ncultures and classes and is considered by\nthe World Health Organization (WHO) to\nbe at the heart of human development. The\nopportunity to enjoy the highest attainable\nstandard of health has been enshrined in the\nWorld Health Organization's Constitution\nfor more than half a century. Yet today, an\nintolerable burden of illness still afflicts a\nlarge part of the world population. For mil-\nlions of people around the world, particu-\nlarly those who live in the poorest segments\nof society, the reality today is one of ram-\npant disease aggravated by poverty and lack\nof knowledge. On the other hand, it is quite\nobvious that development, economic\ngrowth, stability, human dignity and the ful-\nfilment of human rights will only be\nachieved when people are given the oppor-\ntunity to live healthy lives.\nSince health-care is increasingly expensive,\nthe key to break the cycle of disease and\npoverty has to be health promotion and pre-\nvention. But the question is how to do it\neffectively? How to help people prevent\ndisease and fully benefit from the care they\nneed? WHO believes that one solution\ncould be the efficient harnessing of modern\ntechnology to convey electronic informa-\ntion on health to all levels of society. In the\nlast half of the twentieth century, advances\nin technology and telecommunications,\nwhile bringing human beings closer in one\nsense, have also contributed to the ever-\nwidening gap between prosperity and\npoverty and between health and sickness.\nNew drugs and vaccines are being devel-\noped and new disease prevention and con-\ntrol mechanisms envisaged. Technological\nadvance has been unbelievable. But who\nreally benefits from this progress?\nBridging the digital divide\nInformation, and its corollary, knowledge,\ncan indeed either divide or unite, depending\non its use. It gives the means to either\ncorrect social inequities or create them,\nenhance sustainable development or\ndeplete valuable and irreplaceable\nresources. The Health Academy's aim is to\nreach the poorest of the poor all over the\nworld and give them the knowledge they\nneed to protect and improve their health. It\nwill bring information, technology and\nhealth together, in the form of e-learning, to\ncreate awareness and convey pertinent\nbasic health knowledge in a language that\neveryone can understand. This is expected\nto help improving the quality of life and\npromoting more positive attitudes, eventu-\nally leading to a more productive society of\nindividuals. It will also contribute to bridg-\ning the digital divide, which is obviously\nlinked to the social and economic inequali-\nties that exist in the world today.\nWHO's conviction is that information tech-\nnology must be used in the field of educa-\ntion, for the schoolchild, undergraduate,\nand postgraduate, providing the knowledge\nof health specialists for all citizens of the\nworld, particularly in the field of health and\nspecifically in educating future health pro-\nfessionals. Research is providing insights\ninto diseases that were not known before.\nTo keep abreast of the latest knowledge on\nphysiology, pathology, and genetics is an\nenormous task. It is essential that doctors'\nand health professionals' skills and compe-\ntence be maintained and validated. One\nmajor advantage of communication tech-\nnologies is that materials can be instantly\nupdated and disseminated. Textbooks take\ntime to prepare and publish, and are costly\nto distribute.\nBy making health information accessible,\nWHO believes that people will attain a safe,\nhealthy, and productive lifestyle. It should\nalso stimulate a dialogue between the pub-\nlic, medical professionals and policy-mak-\ners. The Health Academy especially takes\ninto consideration individual cultural sensi-\ntivities. With its globally spread education-\nal networks, it will eventually be able to\nconnect people from different nationalities\nand cultures. Such an enhanced global\ninteraction will lead to an exchange of\nknowledge and cultural customs that can\nengender a global society that is rich in its\ndiversity and united in its humanity.\nCarefully validated health\ncontent and state of the art\ntechnology\nWHO's rich information resources and\nexpertise in health issues, as well as its\nworld-wide access to health information in\nall countries, is the main source of validated\nhealth content for the Health Academy. As\nthe main partner in this new initiative, Cisco\nSystems Inc. is providing and developing\nthe e-learning methodology, which goes far\nbeyond simple distance learning. Its essen-\ntial feature is its interactivity, which allows\nthe learner to construct from first principles\nthe very essence of what is being taught and\nto consolidate vital relationships between\neach building block. This approach helps to\ndevelop critical thinking and enhances con-\ncentration capacities. The curriculum is\nexciting to both educators and students, as it\nis a truly interactive mix of different media\ntechnologies. E-learning courses will cover\nmajor health issues including tobacco use,\nblood infections, food safety, nutrition,\nphysical activity, rational use of medicines,\npersonal hygiene, etc.\nThe portal concept has been developed and\ntwo pilot studies were carried out, one in\nEgypt and the other in Jordan. They were\ndirected at 12 to 18-year old students in 20\nschools in each of the two countries. Based\non the evaluation of this experience, the\n76\nWorld Health Organization\nThe Health Academy:\na first step towards a virtual school\nto promote public health world-wide\nHealth Academy will be expanded to other\ncountries and regions of the world, with a\nview to eventually reach the entire popula-\ntion of our planet. Two major dimensions\nwill be taken into account in order to achieve\nthe overall vision: the health condition\ndimension and the cultural dimension. On\nthis basis, the following regional clusters\nmay be identified: Latin and Central\nAmerica, North America and Western\nEurope, the Arab World and the Middle-East\ncountries, Central and Eastern Europe, Sub-\nSaharan Africa, the Indian subcontinent,\nJapan and South East Asia, and Oceania.\nAn initiative with limitless\npossibilities\nBy following these e-learning courses,\nyoung people will rapidly learn the modern\ntechnological skills to acquire new knowl-\nedge. They will develop new attitudes and\nhealthier behaviours and promote good\nhealth messages in their family and com-\nmunity. Improved mental and physical\nhealth will facilitate clarity of mind and\nemotional stability. This in turn will enable\nstudents to take empowering, life-changing\nsteps in all aspects of their lives. As a result,\nindividuals, families, communities and\nnations will become healthier and more\nable to partake in global society.\nThe educational process will not stop at the\nparticipating users enrolled in the courses.\nOnce the Health Academy is established, the\nequipment and courses provided within the\neducation system can be used in the evenings\nby the parents and the general public under\nthe guidance of mentors. This could have\nimportant benefits in improving the teacher-\nparent relationships as well as educating peo-\nple of all age groups in the use of the comput-\ner, accessing Internet and in the subjects\nselected. In addition, the Health Academy\nmay be extended to community Internet cen-\ntres and other points of access. As such, it is\nhoped that health development will become\nentrenched in the society at large.\nThe Health Academy has developed com-\npletely four courses in English. Because the\npilot study was carried out in two Middle\nEastern countries, these courses are also\navailable in Arabic. All courses will eventu-\nally become available in the six United\nNations official languages.\n\u201cThe Health Academy provides unprece-\ndented opportunities for effective health\npromotion through people-centred partner-\nships\u201d said Dr LEE Jong-wook, Director-\nGeneral of WHO, at the launch of this new\ninitiative last December. \u201cIt is more than\njust education; it is a means to influence\nattitudes and behaviour towards a healthier\nlifestyle, which in turn may help reduce\ngaps between prosperity and poverty and\nhealth and sickness.\u201d\nThe launch generated a lot of interest world-\nwide. Government offices, medical institu-\ntions, educational and health organizations,\nuniversities and individuals from all parts of\nthe world contacted the Health Academy to\nrequest more information or to propose col-\nlaboration, suggesting to expand it to specif-\nic regions, countries and languages. This\nhigh level of expectation meets the very aim\nof the Health Academy, which is to become\na virtual school of public health disseminat-\ning validated knowledge and information to\nthe entire global community.\nFurther information: contact Philippe\nStroot,Information and External Relations,\nWHO, 20 avenue Appia, 1211 Geneva 27,\nSwitzerland, tel 41 22 791 4316 e-mail\nstrootp@who.int.\n77\nThe Treaty closed for signature with\nnearly 90% of countries having signed\nand over half the ratifications needed for\nits entry into force having been received\nGeneva, 2 July 2004 \u2013 The World Health\nOrganization Framework Convention on\nTobacco Control (WHO FCTC) closed for\nsignature this week, with nearly 90% of\ncountries having signed and over half of the\nrequired ratifications, keeping the\nConvention on track to become binding\ninternational law by the end of 2004. The\nWHO FCTC has become one of the most\nrapidly embraced United Nations conven-\ntions, with 168 WHO Member States and\nthe European Community (EC) signing, and\n23 countries ratifying, accepting, approving\nor acceding to the Convention, just one year\nafter it opened for signature in Geneva.\nWHO is now helping countries prepare for\nthe moment when the WHO FCTC reaches\n40 ratifications and it comes into force. An\nimportant step in this process included a\nfive-day Intergovernmental Working Group\nin Geneva, chaired by Brazilian\nAmbassador Luiz Felipe de Seixas Corr\u00eaa,\nChair also of the last three rounds negotia-\ntions that led to the accepted text of the\nWHO FCTC. The rapid response to the\nWHO FCTC demonstrates the increasing\ncommitment worldwide to control the\ntobacco epidemic, which continues to\nexpand at alarming rates, especially among\npeople in less-developed countries.\n\u201cAlthough we have good reason to be con-\nfident, a relentless effort will still be need-\ned for the foreseeable future. Current pro-\njections show a rise of 31% in tobacco-\nrelated deaths during the next twenty years,\nwhich will double the current death toll,\nbringing it to almost ten million a year,\u201d\nsaid WHO Director-General Dr. LEE Jong-\nwook to countries attending the Inter-\ngovernmental Working Group. \u201cWhen the\nTreaty comes into force, national and local\nactivities aimed at reversing these trends\nwill be enormously strengthened. The\nresult will be improved public health and\nreduced poverty.\u201d\nWHO has urged countries that have signed\nto ratify the Treaty as soon as possible.\n\u201cThe sooner the 40 ratifications are in\nplace, the sooner effective and coordinated\nactions within the Framework Convention\nWorld Health Organization\nThe WHO Framework Convention on Tobacco\nControl on track to become law by the end of\nthe year\nat country level can begin. Countries can\nrely on WHO for continued support,\u201d said\nDr. Catherine Le Gal\u00e8s-Camus, Assistant\nDirector-General, Noncommunicable\nDiseases and Mental Health, at WHO.\nThe WHO FCTC, adopted unanimously by\nall WHO Member States in May 2003, is the\nfirst public health treaty negotiated under the\nauspices of WHO. It was designed to\nbecome a tool to manage what has become\nthe single biggest preventable cause of\ndeath. There are currently an estimated 1.3\nbillion smokers worldwide. Half of them,\nsome 650 million people, are expected to die\nprematurely of a tobacco-related disease.\nNote\nThe WHO FCTC has, as of 30 June 2004,\n168 signatories (including the European\nCommunity) and 23 ratifications or the\nequivalent. The Parties to the WHO FCTC\nas of 30 June 2004 are Bangladesh. Brunei\nDarussalam, Cook Islands, Fiji, Hungary,\nIceland, India, Japan, Kenya, Maldives,\nMalta, Mauritius, Mexico, Mongolia,\nMyanmar, Nauru, New Zealand, Norway,\nPalau, Seychelles, Singapore, Slovakia and\nSri Lanka.*\nThe WHO FCTC has provisions that set\ninternational standards on tobacco price\nand tax increases, tobacco advertising and\nsponsorship, labelling, illicit trade and sec-\nond-hand smoke. The Treaty will enter into\nforce and become law for the countries that\nare parties to it 90 days after the 40th ratifi-\ncation or equivalent instrument. Seventeen\nmore Parties are needed for the entry into\nforce of the Treaty.\nDuring the Intergovernmental Working\nGroup from 21 to 25 June in Geneva, dele-\ngates elaborated proposals on different proce-\ndural, institutional, financial and budgetary\nissues that will be presented to the WHO\nFCTC Conference of the Parties for its con-\nsideration and adoption. The Conference of\nthe Parties (COP), formed by all Parties to the\nTreaty, will take place during the year follow-\ning the entry into force of the WHO FCTC.\nCountries that have not signed at this date\nwishing to become party to the Treaty can\ndo so by means of accession. For signato-\nries of the Treaty, there is no deadline for\nratification (equivalent).\nFor the current status and full text of the\nWHO FCTC, please visit:\nwww.who.int\/tobacco\/areas\/framework\/sig\nning_ceremony\/countrylist\/en\/\nFor further information, please contact\nMarta Seoane, Communications Officer,\nTobacco Free Initiative, WHO Geneva,\nTel.: +41 22 791 2489, mobile: +41 79475\n5551, e-mail: seoanem@who.int\n78\nWHO issues new recommendations for\nGinseng, Echinacea and other medicinal\nplants\nGeneva: The World Health Organization\nhas released guidelines for good agricultur-\nal and collection practices for medicinal\nplants \u2013 an industry estimated to be worth\nmore than US$ 60 billion. The guidelines\nare intended for national governments to\nensure that production of herbal medicines\nis of good quality, safe, sustainable and\nposes no threat to either people or the envi-\nronment.\nHerbal medicines could be the natural\nanswer to some ailments and can often be\nreadily available. For these reasons, they\nare growing in popularity in wealthy coun-\ntries and their use remains widespread in\ndeveloping regions.\nHowever, reports of patients experiencing\nnegative health consequences caused by the\nuse of herbal medicines are on the rise. One\nof the major causes of adverse events is\ndirectly linked to the poor quality of herbal\nmedicines, including raw medicinal plant\nmaterials, and to the wrong identification of\nplant species. Cultivating, collecting and\nclassifying plants correctly are therefore of\nthe utmost importance for the quality and\nsafety of products.\nIn addition to patient safety issues, there is\nthe risk that a growing herbal market and its\ngreat commercial benefit might pose a\nthreat to biodiversity through over-harvest-\ning of the raw materials for herbal medi-\ncines and other natural health care prod-\nucts. If not controlled, these practices may\nlead to the extinction of endangered species\nand the destruction of natural habitats and\nresources.\nThe WHO guidelines on good agricultural\nand collection practices (GACP) for medici-\nnal plants are an important initial step to\nensure good quality, safe herbal medicines\nand ecologically sound cultivation practices\nfor future generations. In an easy-to-under-\nstand style they cover the spectrum of culti-\nvation and collection activities, including site\nselection, climate and soil considerations and\nidentification of seeds and plants. Guidance\nis also given on the main post-harvest opera-\ntions and includes legal components such as\nnational and regional laws on quality stan-\ndards, patent status and benefit sharing.\nBackground facts\nThe safety and quality of raw medicinal\nplant materials and finished products\ndepend on intrinsic (genetic) or external\n(environment collection methods, cultiva-\ntion, harvest, post-harvest processing,\ntransport and storage practices) factors.\nInadvertent contamination by microbial or\nchemical agents during any of the produc-\ntion stages can also lead to deterioration in\nsafety and quality. Medicinal plants collect-\ned in the wild may be contaminated by\nother species or plant parts through\nWorld Health Organization\n* edit: The number of countries which have ratified\nor taken equivalent action had risen to 30 (August\n2004)\nHerbal medicines\nMedicinal Plants \u2013 Guidelines to Promote\nPatient Safety and Plant Conservation for a\nUS$ 60 Billion Industry\nmisidentification, accidental contamination\nor intentional adulteration, all of which may\nhave unsafe consequences.\nAdverse reactions due to substitu-\ntion of incorrect plant:\nDigitalis: Cases of serious cardiac arrhyth-\nmias were reported in the USA in 1997 fol-\nlowing the accidental substitution of plan-\ntain, to be used as a dietary supplement, with\nDigitalis lanata, generally used for heart\nconditions. Subsequent investigations were\nreported to reveal that large quantities of the\nmisidentified plantain had been shipped to\nmore than 150 manufacturers, distributors\nand retailers over a two-year period.\nPodophyllum: Fourteen cases of\nPodophyllum poisoning have been reported\nfrom Hong Kong Special Administrative\nRegion of China, following the inadvertent\nuse of the roots Podophyllum hexandrum\ninstead of the Gentiana and Clematis\nspecies for the antiviral qualities. It is\nreported that this accidental substitution\narose because of the apparent similarity in\nthe morphology of the roots.\nAconitum: Cases of cardiotoxicity resulting\nfrom the ingestion of Aconitum species used\nin complementary medicine for acute infec-\ntions and panic attacks have been reported\nfrom Hong Kong, China. Aconitum root-\nstocks are processed by soaking or boiling\nthem in water in order to hydrolyse the\naconite alkaloids into their less toxic, aco-\nnine derivatives. Toxicity can, however,\nresult when such processes are mismanaged.\nIn the United Kingdom, the internal use of\naconite is restricted to prescription only.\nEndangered medicinal plants:\nThe wild types of the popular medicinal\nplant ginseng (Panax ginseng), used to\naddress digestive conditions resulting from\nnervous disorders, is currently reported to\nbe rapidly declining due to increasing\ndemand and collection.\nWild Amercian ginseng, goldenseal, echi-\nnacea, black cohosh, slippery elm and kava\nkava top the \u201cat-risk list\u201d of endangered\nspecies of medicinal plants.\nCultivation has replaced wild collection for\nthe supply of some essential drugs used in\nmodern medicine. The Madagascar rosy\nperiwinkle, Catharanthus roseus, is widely\ncultivated in Spain and the United States for\nits properties which are considered useful\nin treating childhood leukaemia and\nHodgkin\u2019s disease.\nA traditional medicine for which demand is\ngreater than the potential for supply is the\nAfrican Pygeum tree (Prunus africana). The\nbark is a very popular natural remedy for\nprostate disorders in some European coun-\ntries such as Spain \u2013 but it is harvested from\nwild trees growing in the mountain forests\nof continental Africa and in Madagascar and\nis unsustainable under current practices.\nWhile the bark can be harvested sustainably,\nharvesters either cut too much, which results\nin the death of the trees, or they fell whole\ntrees. The International Centre for Research\nin Agroforestry (ICRAF) and others are\nworking to establish sustainable sources of\nPrunus africana through conservation of\nwild tree populations and assistance to\nsmallholders to grow the tree \u2013 something\nthat will also help increase farmers\u2019\nincomes. ICRAF is also working on a breed-\ning programme to select varieties which will\ntake less time to reach harvestable age.\nDevil\u2019s Claw, Harpagophytum procum-\nbens, is another popular remedy that is\nunsustainably harvested and may become\nextinct in the wild under current practices.\nIt has been used as a tonic, as a treatment\nfor arthritis and rheumatism, to reduce\nfever, ease sore muscles, and reduce choles-\nterol, and externally the ointment is used to\ntreat sores, boils, and ulcers. It is also used\nto cleanse the lymph system and to remove\ntoxins from the blood.\nDevil\u2019s Claw is produced in southern Africa,\nand Namibia is the biggest exporter in the\nregion. Just under 200 tonnes were exported\nfrom Namibia between January and August\n2000. Between 10,000 and 15,000 har-\nvesters rely on sales from its collection as\ntheir only source of cash. However, current\nprices are not a true reflection of the real\nvalue of their work; indeed, over the last 24\nyears the price has dropped by as much as\n85%. In 1998, a sustainably harvested\nDevil\u2019s Claw project was set up on a reset-\ntlement farm in Namibia and has rapidly\nexpanded. The following year, 10,210 kg of\ncertified organic Devil\u2019s Claw was pro-\nduced, providing local people with a sus-\ntainable product at a guaranteed and fair\nprice. This could be the way forward, pro-\nvided that users of Devil\u2019s Claw demand\nthat suppliers stock only certified products.\n79\nWorld Health Organization\nGeneva \u2013 The World Health Organization\nhas warned of dire health consequences for\nmillions of people in Darfur, Sudan. A sig-\nnificant increase in disease and death is\ninevitable without a rapid increase in exter-\nnal help. The catastrophe can only be pre-\nvented through an urgent scaling up of the\ncurrent international response.\nGreater Darfur is comprised of three States\nwith a population of 6.7 million. The\nhumanitarian crisis has displaced more than\n1.2 million people from their villages and\nhomes and Iffected two million in total. In\nat least one instance, the child mortality rate\nrose to three times higher than the interna-\ntional threshold for a humanitarian emer-\ngency (two deaths per 10,000 under-five\nchildren per day).\nOn 3 June, Ministers and senior officials\nfrom donor nations met in Geneva to inten-\nsify their response to the crisis in Darfur.\nBold and decisive action is needed now.\nWHO estimates that a humanitarian crisis\ncan only be prevented through a rapid scal-\ning up in the responses, especially during\nthe next three months, WHO now seeks\nHumanitarian aid\nDire Health Consequences for Millions of\nPeople in Darfur, Sudan, and Calls for\nIntensified Health Response\nUS$ 7.6 million for the health response in\nDarfur as part of US$ 30 million needed for\nhealth work throughout Sudan, to help the\nGovernment coordinate the response of the\nhealth sector and tackle disease outbreaks,\nimprove sanitation, respond to public health\nneeds and improve access to medical care.\nThe deepening Darfur crisis\n\u201cDeath and disease spiral upwards when\nthere is inadequate food, unsafe water,\nimproper sanitation and shelter, widespread\nviolence, lack of public health inputs like\nvaccinations and insufficient access to med-\nical care. These are the realities of the cur-\nrent crisis in Darfur,\u201d said WHO Director-\nGeneral LEE Jong-wook. \u201cThe world must\nnot stand by as conflict is compounded by\nrising rates of death that could be prevented\nthrough concerted action.\u201d\nIn October 2003, the United Nations warned\nof an imminent humanitarian crisis in Darfur\nand appealed for extra resources. After a\nlong delay, funds are now being pledged.\nSubsequently, needs have increased. During\nApril 2004, the number of affected people\nrose to two million, with at least 1.2 million\ninternally displaced and 100,000 refugees in\nChad. Reports suggest continuing increases\nin levels of malnutrition (doubling each\nweek in some settings), diarrhoea, measles\nand death. WHO has, so far, been promised\na total of US$ 3.9 million for its response.\nDr Hussein Gezairy, WHO Regional\nDirector for the Eastern Mediterranean\nRegion, stated that, \u201cDelivering much-\nneeded aid is an immense challenge in\nDarfur because people are scattered over a\nvast land area, and communications have\nbeen badly disrupted. Accessing those in\nneed requires intense collaboration by all. A\nmassive scale-up in international commit-\nment, action and effective ground presence\nis needed now to save precious lives.\u201d\nThe UN and non-governmental orga-\nnisations have faced many challenges in\ntheir efforts to scale up action in Darfur dur-\ning the past few months. The immediate pri-\nority now is to save lives and mitigate the\noverall risk, exacerbated by the onslaught of\nthe rainy season, to the health of the affected\npopulations. This will require skilled public\nhealth staff properly equipped to tackle dis-\nease, initiate immunization campaigns,\nensure water quality and proper sanitation\nand make sure that priority surgical and\nmedical care is available where it is needed.\nThe Ministry of Health, WHO and partners\nhave identified needs and priorities, and are\ntogether working to deploy Sudanese physi-\ncians and surgeons to Darfur hospitals and\nhealth centres urgently, in coordination with\nthe UN system as well as NGOs.\nIn the short term, there is an urgent need for\nskilled and experienced international senior\npublic health specialists, together with sur-\ngeons, physicians, nurses and logisticians,\nto work in Darfur under the direction of the\nGovernment of Sudan and WHO. They\nneed equipment and supplies in order to be\neffective.\nWHO welcomed recent assurances from\nthe Government of Sudan that permits for\nhumanitarian workers to travel from\nKhartoum to Darfur would be issued within\n48 hours, and that movement of relief sup-\nplies will be facilitated.\nA call to action\nNow the misery of Darfur is becoming\napparent to all the world's leaders. WHO\nreiterated its call for action to counter this\nhuman suffering. The UN system and\nNGOs need sustained and committed finan-\ncial and political backing to counter what\ncan only be described as a disaster.\nSome recent actions for\nhealth in the Darfur crises\nWHO has had staff in Darfur since the end\nof 2003 and provides regular assessments\nof people's health situation and needs.\nWHO helps coordinate and oversee interna-\ntional support for public health in Darfur.\n\u2022 Disease Surveillance and Preparation\nfor Outbreaks: an early warning system\nfor cholera, dysentery, and malaria, is\nrun by 52 trained surveillance officers,\nwith pre-placement of outbreak\nresponse materials in the three States.\n\u2022 Measles Vaccination Campaign: the\nMinistry of Health, UNICEF, WHO and\npartners are making final preparations\nfor a massive measles vaccination cam-\npaign covering more than two million\nchildren in Darfur. This will supplement\nthe measles care being undertaken by\nNGOs, targeting children between the\nages of nine months and 15 years. As\npart of the campaign, children will\nreceive vital Vitamin A supplements and\nvaccination against poliomyelitis.\n\u2022 Environmental Health: 172 environ-\nmental health workers have been trained\nand equipped to ensure that vector con-\ntrol, waste disposal measures and health\npromotion are in place for 310,000 peo-\nple in four locations: El Mashtel, Abu\nShouk and Kaalma, and Geneina.\nFor more information: IN KHARTOUM: Dr Guido\nSabatinelli, WHO Representative to Sudan, Tel: 24911 780\n190, Mobile: 249 121 39 448, Fax 249 11 77 62 82 E-Mail:\nwhsud@sudanmail.net.sd; IN CAIRO: Dr Ibrahim\nKerdany, Senior Information Officer, WHO, Tel: 00202\n2765037, E-Mail kerdanyi@emro.who.int; More informa-\ntion on WHO's response in Darfur can be found on\nhttp:\/\/www.who.int\/disasters.\n80\nRegional &#038; NMA News\nRegional and NMA News\nDrug Costs in Europe\nWhile there is universal concern about the\ncost of medicines, it is interesting to note the\nreport in Euro Observer* that in Denmark\nwhile drug prices have fallen by about 20%\nsince 1995, public sector prescription drug\ncosts continue to rise. Costs in 2003 showed\na 5.7% rise over the previous year. This is\nattributed to \u201crising drug consumption due\nto demographic developments and the intro-\nduction of new drugs on the market.\u201d\nIn the same newsletter, it is reported that in\nFinland, generic substitution, which was\nintroduced into the Social Insurance\nSystem (Kela) in April 2003, produced a\n81\nBecause Canada is a federation of one fed-\neral, three territorial and ten provincial gov-\nernments, political jockeying at different\nlevels is a well-established part of Canadian\nlife. At no time is this more abundantly\nclear than when health care is involved.\nIn fact, health care issues dominate\nCanadian political life to such an extent that\nthey were the overriding theme of most\npolitical advertising and debate during the\nJune 2004 federal election.\nThese diverging views and opinions can\nplace an organization like the Canadian\nMedical Association (CMA) in the no-\nman\u2019s land between competing political\ninterests and visions. And although life in\nno-man\u2019s land can be difficult, it also pre-\nsents powerful opportunities to affect polit-\nical outcomes.\nIn Canada, these opportunities have never\nbeen greater.\nFirst, after a strident election the political\ngods conspired on June 28 to give Canada\nits first minority federal government in 25\nyears. This means the new Liberal govern-\nment will have to attract allies because it\nholds only 135 of the 308 seats in Canada\u2019s\nHouse of Commons. (The CMA takes a\nneutral stance in all federal elections and\nsupports no political party before or during\nan election campaign. Although it raises\nhealth care issues, it never supports a par-\nticular political party during a campaign.)\nSecond, from this new minority position\nPrime Minister Paul Martin must deal with\na restive group of provincial and territorial\npoliticians who appear more ready than\never to challenge the federal government on\nhealth care funding.\nCombine these two facts, says Dr. Sunil\nPatel, who was the CMA\u2019s president during\nthe federal election, and the health care\ndebate in Canada is approaching a crucial\njuncture. He thinks Canada\u2019s physicians are\nideally placed to affect the outcome.\nIt is notable, he says, that Canada\u2019s new\nfederal minister of health, Ujjal Dosanjh,\nchose the CMA\u2019s 2004 annual meeting in\nAugust as the venue for his first major\nspeech \u2013 exactly one month before the\nprovincial premiers and federal prime min-\nister hold an extraordinary \u201cFirst Ministers\u201d\nmeeting dealing solely with health care.\n\u201cIt will be interesting to see what messages\nthe federal government chooses to deliver\nat our meeting,\u201d said Dr. Patel, whose term\nended during the 2004 annual meeting. \u201cA\nlot of people, and not just doctors, will be\nwatching this closely.\u201d\nHe was right. Delegates were addressed by\nPremier Dalton McGuinty of Ontario,\n(which, with a population of 11 million\npeople is Canada\u2019s biggest province) as\nwell as by Mr. Dosanjh and Roy Romanow,\nwho led a 2002 federal royal commission\non health care. Their comments dominated\nCanadian media reports while the Aug. 16-\n18 CMA meeting was taking place.\nThe health care issues confronting\nCanada\u2019s politicians are both considerable\nand controversial. For example:\n\u2022 How much should each level of govern-\nment spend to provide health care? The cur-\nrent annual bill is C$120 billion for every-\nthing from physicians\u2019 fees to drug costs and\ndentists\u2019 bills. Governments are responsible\nfor about 70 percent of the total, and the\nprovinces and territories claim they have\nbeen left with too large a share to pay because\nof deficit-cutting efforts at the federal level.\n\u2022 What role should privately owned for-\nprofit facilities play in the delivery of health\ncare? This is supposed to be strictly con-\ntrolled under federal legislation, but length-\nening waiting lists within the public system\nare causing concern. The key question: Is\nthe existing system sustainable?\nThe CMA has responded with a multi-\npronged effort to publicize problems and\npotential solutions.\nFor example, the Association\u2019s 137th annu-\nal meeting was held in Toronto Aug. 16-18,\nand it kicked off with a one-hour \u201cstrategic\nsession\u201d on health care waiting times,\nchaired by Dr. David Naylor, dean of med-\nicine at the University of Toronto. The next\nday Dr. Dana Hanson, the CMA\u2019s past pres-\nident, released results of a year-long study\nof personnel problems facing Canada\u2019s\nhealth care professions. However, although\na maximum of only 260 physician dele-\ngates attend the CMA\u2019s General Council,\nthe real audience is much larger because\nmany reporters attend the meeting.\nDr. Patel says it was easy to choose this\nyear\u2019s accessibility-to-care theme. \u201cThe\nfederal election proved that it is Canadians\u2019\nmajor concern,\u201d he said, \u201cand we already\nknew that it is the issue that worries doctors\nmost.\u201d\nThe CMA, which launched a major cam-\npaign promoting the need for better access\nto care in February, commits significant\nresources to public opinion polling, and\nthose results play a major role in its advoca-\ncy efforts.\nWaiting lists are a case in point.\nThe CMA is trying to convince Canadian\ngovernments at all levels that the country\nhas a shortage of health care personnel. To\nsupport its arguments, it polled 1500 adults\nin February 2004 and learned:\n\u2022 Barely one in ten Canadians (14 percent)\nnow believes that the country has an ade-\nquate supply of physicians, a significant\ndecline since 1999 (35 percent).\n\u2022 Concern about access to advanced diag-\nnostic procedures has risen significantly.\nRegional &#038; NMA News\nsaving of \u20ac 39.7 (US$47.6) million in the\nfirst six months. While prescribing physi-\ncians can refuse to authorise \u201csubstitution\u201d,\nduring this period only 0.4% were not\nallowed by the prescriber. The savings are\ncontinuing, with combined savings of\napproximately \u20ac 48.6 (US$58.3) million\nbetween October 2003 and March 2004.**\n* Euro Observer 2004, 6 (2).\n** see also Kela website, www.kela.fi\/research, consulted\non 02.08.04\nThe politics of health care \u2013 tackling health care\nproblems Canadian style\nOtmar Kloiber\nIn 1994 a chip-based electronic patient card\nreplaced a paper-based voucher granting\naccess to medical care under statutory\nhealth insurance for 70 million people. High\nexpectations in the new tool came to a quick\nend when the state data protection officers\npointed out that the chip must not to be used\nfor any other purpose than identification. As\nthe law only permitted storage of ID data,\nany other use would require legislation.\nThis decision today looks like an act of\nwise prescience as the main effect of the\npatient card has been an excessive \u201cdoctor-\nhopping\u201c, accompanied by a variety of\nfraudulent uses. The old card turned out to\nbe completely unsafe: it can easily be\ncopied, has no crypto-functions for confi-\ndential or private information and practical-\nly it cannot be revoked. Fraudulent use pro-\nduces an estimated damage of more than 1\nbillion Euro a year.\nThere is no doubt that telematics in medicine\n(\u201ce-health\u201d) will help to provide better med-\nicine and to provide medicine in better way.\nHowever, estimates of how much money\ncould be saved by using telematics (they\nrange between 300 and 500 thousand Euro\nper year for the introduction of the electron-\nic prescriptions alone) are rather speculative.\nNevertheless, the government introduced an\nintelligent mandatory \u201cHealth Card\u201c in leg-\nislation last year as part of over 400 pages of\namendments to the Social Code which were\nadopted. The intelligent cards as described in\nthe law will obligatorily carry electronic pre-\nscriptions, as they should give \u201croom\u201d for a\nmedication history, emergency information\nand an electronic patient record.\nCurrently there is no card with all these\nanticipated functions on the market and in\nuse. On the other hand, nobody seems to\ndoubt that they are technically possible.\nDuring the parliamentary procedure the\nproposal was passed without opposition.\nFrom the medical community two things\nwere criticised: first, the time frame set by\nlaw for the introduction of the Health Card\nwas unrealistic; second, there was no men-\ntion of financing the Health Card imple-\nmentation in the Law.\nThe countrywide introduction of the Health\nCard for virtually all people living in\nGermany by January 1, 2006 appeared to\nmost experts and leaders of the health care\nsystem completely unrealistic. As with all\nthings in the statutory health care system the\nrealization of the project has to be done by\nthe self-governing institutions of the sick\nfunds and the providers. Usually they regu-\nlate their interaction by contracts, without\ninfluence from the government. For the intro-\nduction of the Health Card into the Social\nSecurity system, the government introduced\nan amendment into the law. This enabled the\ngovernment to withdraw the implementation\nfrom the self-governing bodies, if it decided\nthat they are unable to carry out this task.\nWhile the self-governing bodies claimed that\nthe time frame was unrealistic, the govern-\nment claimed that the self-governing bodies\nare simply unable to do the job.\nObviously to augment the tension, the gov-\nernment did not introduce any indication as\nto how to finance the introduction of the\nHealth Card. This is a tricky situation as the\ninvestment, that may amount to 1.6 billion\nEuro, would substantially fall on the\nproviders who had to purchase card readers,\nnew software, DSL or ISDN \u2013 lines, equip-\nment, and the health professional card.\nHowever, the return on investment would\nalmost exclusively go to the sick funds.\n82\nRegional &#038; NMA News\nWhen asked if they had to wait \u201clonger than\nyou thought was reasonable\u201d for these pro-\ncedures in the past year, 31 percent\nanswered affirmatively, compared with\nonly 14 percent in 1999.\nThe CMA, which represents 58 000 practis-\ning physicians, residents and medical stu-\ndents, responded with a National Health\nAccess Campaign. \u201cWe are making a sim-\nple argument,\u201d Dr. Patel told reporters dur-\ning the campaign launch. \u201cAccessibility is\nthe currency of the health care system, and\nif people lose faith in that currency \u2013 in\ntheir ability to get care when they need it \u2013\nCanada\u2019s medicare system won\u2019t survive.\nWe want to ensure its survival.\u201d\nThe same message was delivered via a\nCMA \u201cElection Tool Kit\u201d prepared for the\n2004 federal election. It outlined the major\nchallenges facing health care and provided\nquestions physicians could ask their local\ncandidates.\nFinally, a major report on the personnel\nissues facing medicine was released during\nthe 2004 annual meeting. It called for\nCanada to rely less on doctors imported\nfrom other countries \u2013 international med-\nical graduates account for about 24 percent\nof Canada\u2019s doctors, and the country has\nfaced charges of poaching, particularly\nfrom South Africa. The report proposed that\nenrolment at Canada\u2019s 16 medical schools\nbe increased to 2,500 spaces per year (cur-\nrently 2,200).\nAlthough problems dogging the health care\nsystem account for much of the CMA\u2019s\nadvocacy efforts, it also takes concerted\naction on specific medical issues. For\ninstance, when SARS struck Canada in\n2003, the CMA compiled a list of physi-\ncians who were willing to help out their\nhard-pressed colleagues in Toronto \u2013 the\nepicentre of the epidemic in North\nAmerica.\nAnd it remains an impassioned critic of\nsmoking. In March the CMA sent letters to\nall major cities that host conventions\nannouncing that it will no longer hold annu-\nal meetings in cities that allow smoking in\nindoor public places such as restaurants.\nMore than 100 Canadian cities have already\nannounced such bans.\nPatrick Sullivan\nSenior Manager, Member\nCommunications, CMA\nPersonal View\nCard Games \u2013 lessons on high stake gambling\nfrom the German Health Care System\nWith this constellation of an unrealistic\ntime frame and a potential financial dispute,\nthe Ministry increased the chances of fail-\nure. This appears to be deliberate as the\nMinistry had always suggested giving the\nwhole project to the IT-service industry.\nThe idea of the Ministry is that IT-service\ncompanies would provide the whole system\nfor health telematics at their own cost, and\nmake a charge for each transaction that will\nbe made with the system. Of course the IT-\nindustry looks for more. With the introduc-\ntion of the Health Card and the telematic\ninfrastructure, they are looking towards tak-\ning over the whole financial management\nof the health care system. The game is not\nabout the small change for telematics, it is\nabout the ownership of the process.\nThis of course would lead to a totally new\nhealth care system. Currently the law does\nnot permit the government to interfere with\nthe financing of the health care system.\nFinancing has to be regulated between sick\nfunds and providers only. Taking the health\ncard introduction away from the self-gov-\nerning bodies on the grounds of incompe-\ntence as proposed would allow the govern-\nment indirectly to contract the transaction\nsteering to the IT-industry, thus gaining\ninfluence over the cash flow in the health\ncare system, which by law has to be strictly\nseparated from the government. The seri-\nousness of the Ministry's intention may be\nindicated by the fact that several employees\nof different IT companies are working in\nthe ministry full time \u2013 paid by the industry.\nDeus ex machina\nSometimes relief comes from a side one does\nnot expect. Earlier the Ministry of Transport\ncontracted a toll collection system out to the\nIT-Industry. The system would collect road\nfees from those lorries using the German\nAutobahn. Instead of choosing an established\ntechnique, the German Government contract-\ned a highly sophisticated model that would\nallow the contractors not only to collect the\ntoll for the government but also to offer\nhauler services, such as fleet management\nand cargo dispatch. But unlike the technolog-\nically simpler models already in use in other\ncountries, the German \u201cToll Collect\u201d system\nwas not more than an idea.\nThe introduction of the toll collect system\nbecame a complete disaster. Its failure led\nto major deficits in toll collection and also\nto the realisation that the IT-industry does\nnot always deliver what they promise, and\nthat the commercialisation of state func-\ntions may not always be the best way to go.\nEvery politician now has to be aware that\nsuch a liaison with the industry may be his\npolitical end if it fails \u2013 and the possibility\nof failure is a real, one.\nThe simple sociological principle that two\ncounterparts will unify if they are disturbed by\na third one worked for the self-government in\nthe health care system. In a very short time\nsince the beginning of this year, a common\ninstitution was set up and the financing of the\nwhole system is about to be agreed. That is\nmore than could have been expected in such a\nshort time. However, a previous apparently\nacademic dispute about the way an electronic\nprescription should travel resurfaced: As gov-\nernment and providers assume that the health\ncard would be a good place to carry the e-pre-\nscription, the sick funds wish to have a serv-\ner-based push and pull system. The nearly\nreligious way sick funds make this a dogma\ncan only be explained by their wish to provide\nthese prescription servers and have direct con-\ntrol over the doctors' prescriptions as means\nof a concurrent review. But again the cards are\nnot open and the game continues.\nAddress for correspondence:\notmar.kloiber@baek.de.\nThe views expressed in this article are those of\nthe author and not those of the WMJ or the WMA.\n83\nReview\nRuth Macklin\nCambridge University Press, 2004\n\u00a350.00 (hb), \u00a322.99 (pb), pp. viii, 280\nISBN 0 521 83388 4 (hb), 0 521 54170 0 (pb)\nRuth Macklin, Professor of Bioethics at\nAlbert Einstein College of Medicine in New\nYork, has been for many years both an\nactive participant-observer in, and a widely-\npublished analyst of, the debates over stan-\ndards for research on human beings in\ndeveloping countries. In this book she\nreviews the principal ethical issues that have\nbeen addressed in these debates, analyses\nthe responses that have been provided by\norganizations such as the WMA, and offers\nher own proposals for resolving the issues.\nAs the title of the book indicates, the\nauthor\u2019s principal concern is whether it is\nethically acceptable to have standards in\nresearch ethics for developing countries\nthat differ significantly from those in indus-\ntrialized countries. She poses four ques-\ntions to illustrate this concern:\n1. How can biomedical research be\ndesigned and conducted so as to con-\ntribute to the health needs of developing\ncountries and at the same time contain\nadequate protections for the rights and\nwelfare of the human subjects recruited\nfor these studies?\n2. If a particular study may not be conduct-\ned in the sponsoring country for ethical\nreasons, is it acceptable to carry out an\nidentical study in a developing country,\nand, if so, with what justification?\n3. When completed research yields suc-\ncessful products or other beneficial inter-\nventions, what obligations, if any, do the\nsponsors have to the community or coun-\ntry where the research was conducted?\n4. Should the provisions of international\nethical guidelines for research, such as\nthe Declaration of Helsinki, be inter-\npreted and applied in the same way in\nresource-poor countries as they are in\nwealthier countries? (p. 14).\nIn responding to these questions, Macklin\nanalyses and evaluates the different answers\nprovided in such recent documents as the\nReview\nDouble Standards in Medical Research in\nDeveloping Countries\n2000 Declaration of Helsinki (with its 2002\nNote of Clarification), the 2000 UNAIDS\ndocument, Ethical Considerations in HIV\nPreventive Vaccine Research, the 2001\nNational Bioethics Advisory Commission\n(USA) report, Ethical and Policy Issues in\nInternational Research, the 2002 Nuffield\nCouncil on Bioethics (U.K.) report, The\nEthics of Research Related to Healthcare in\nDeveloping Countries, the 2002 Council for\nInternational Organizations of Medical\nSciences (CIOMS) International Ethical\nGuidelines for Biomedical Research\nInvolving Human Subjects, and related policy\ndocuments from the USA National Institutes\nof Health, and the Food and Drug Ad-\nministration, and the U.K. Medical Research\nCouncil, as well as comments on earlier ver-\nsions of some of these documents and articles\nin medical and bioethical journals.\nThe two articles in the 2000 version of the\nDeclaration of Helsinki that have generated\nthe most controversy, paras 29 and 30, are\ngiven particular scrutiny by Macklin. The\nrequirement of para. 29, that an experimental\ntreatment be tested against the best current\none, where such exists, has been modified or\nrejected in most, if not all, of the more recent\ndocuments listed above. Macklin criticizes\nthese documents for deferring to pragmatic\nconsiderations, such as the extra cost of com-\nparing an experimental drug to an existing\none instead of a placebo, rather than focusing\non ethical principles such as justice and how\nthey can be achieved. She also has harsh\nwords for the WMA\u2019s Note of Clarification to\npara. 29: \u201cA major problem is that the clarifi-\ncation fails to clarify. \u2026it provides no criteria\nfor the \u2018compelling reasons\u2019 that could justi-\nfy departure from the principle\u2026 [and there-\nfore] it would allow participants in research\nto be subject to predictable serious or irre-\nversible harm\u201d (p. 48). Like many critics of\nthe Note of Clarification, Macklin does not\npay sufficient attention to its last sentence,\n\u201cAll other provisions of the Declaration of\nHelsinki must be adhered to\u2026\u201d\nPara. 30 of the Declaration of Helsinki has\nlikewise proved extremely challenging in the\ndevelopment of subsequent documents. Its\nrequirement that participants in research stud-\nies should be among the beneficiaries of the\nstudy if the study succeeds has been widely\ncontested, both on principle and on pragmatic\ngrounds. Macklin cites the National Institutes\nof Health and the Food and Drug\nAdministration of the USA as the strongest\ncritics of para. 30, and a related but somewhat\nbroader CIOMS Guideline that \u201cany product\ndeveloped will be made reasonably available\nto that population or community.\u201d\nMacklin accuses those who reject the prin-\nciples embodied in paras. 29 and 30 of the\nDeclaration of Helsinki of legitimizing an\nunacceptable double standard in research,\nsince there are stricter rules for placebo-\ncontrolled trials and much easier access to\nnew drugs in wealthy countries than in poor\nones. Against those who claim that medical\nresearch should not be used as a tool to\nfight world poverty, Macklin suggests that\nthe ethical principle of justice and various\ninternational human rights statements\nrequire efforts on the part of the powerful\nand wealthy, whether governments or cor-\nporations, to lessen international disparities\nwherever they exist, including the treatment\nof human research subjects. However, she\nacknowledges that there are irreconcilable\ndifferences regarding the extent of this\nobligation and how it can best be fulfilled.\nThe appropriateness of double standards\narises in discussions of other issues in\nresearch ethics besides those dealt with in\nparas. 29 and 30 of the Declaration of\nHelsinki. Macklin rejects the suggestion that\npromising the best current treatment and\/or\naccess to the benefits of a research study\nwould constitute undue inducement to\npotential research subjects in developing\ncountries and thereby compromise their abil-\nity to give informed consent to participation\nin the study. As to whether the standard\nrequirements for informed consent in devel-\noped countries can be relaxed elsewhere, for\nexample, by allowing a potential research\nsubject\u2019s husband or a community leader to\nconsent on behalf of others, Macklin favours\nuniversal application of the basic principles\nof research ethics, such as the requirement of\nindividual consent, but flexibility in the\nprocesses by which the principles are\napplied, e.g., written vs. oral consent.\nBesides addressing the substance of the var-\nious research ethics documents, Macklin\nraises issues concerning their nature. Should\nthey be pragmatic or aspirational, descriptive\nor prescriptive? In her view they should be\nboth pragmatic and aspirational but prescrip-\ntive rather than descriptive: \u201cSince ethics is\nabout what ought to be, rather than simply\nwhat is, the answer \u2026 is easy. The difficulty,\nhowever, is to craft guidelines that are use-\nfully prescriptive without being hopelessly\naspirational\u201d (p. 30). As to whether it is pos-\nsible to harmonize the various international\nstatements, she is pessimistic because of the\nradically different interests of the parties\nconcerned, including protection of research\nsubjects, addressing international inequali-\nties, promotion of research and maximizing\ncommercial profits. Moreover, none of the\norganizations that have produced these doc-\numents has unquestioned authority in the\narea of research ethics.\nAlthough she does not hesitate to state her\nown views on the various issues she treats,\nMacklin consistently provides thorough\nand accurate summaries of all the positions\non the issues, including those she criticises.\nIn addition, she analyses with care the prin-\ncipal concepts in the debate on double stan-\ndards, including \u2018double standard\u2019 itself,\n\u2018standard of care\u2019, \u2018equity\u2019\/\u2018equality\u2019, and\n\u2018exploitation\u2019, and criticizes their use as jar-\ngon or slogans. She does not hesitate to\nsuggest practical solutions for overcoming\ndouble standards in research, such as:\n1. differential pricing and financing of\nessential drugs;\n2. negotiations followed by prior agree-\nments before research is initiated;\n3. collaborative efforts among internation-\nal agencies and the creation of public-\nprivate partnerships; and\n4. manufacture of generic copies of patent-\ned drugs in developing countries and\nsale of such drugs to other poor coun-\ntries (p. 165).\nThrough the adoption of such measures,\nMacklin concludes, \u201cMaintaining the same\nethical standards for research will not thwart\nthe research enterprise, but can help to\nensure that judgments made at some future\ntime will not condemn the current era as one\nthat accepted and even endorsed double\nstandards of research ethics\u201d (p. 260).\nJohn R. Williams\n84\nReview\n\n<\/p>\n"},"caption":{"rendered":"<p>wmj3 WorldMMeeddiiccaall JJoouurrnnaall Vol. No.3,september200450 OFFICIAL JOURNAL OF THE WORLD MEDICAL ASSOCIATION, INC. G 20438 Contents EEddiittoorriiaall Fifty Years Of Smoking Research 57 Public\/Private Financing and Health Research 58 Genetics Underlying Diabetes 59 MMeeddiiccaall EEtthhiiccss aanndd HHuummaann RRiigghhttss Migration of Health workers: Critical issues in the global debate 60 Biomedical Research In Europe 64 UN [&hellip;]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":727,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2016\/11\/wmj3.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3524"}],"collection":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/comments?post=3524"}]}}