Foden, A P

Grolman, D

Hodgson, R E

Williams, P G

South African Medical Journal (SAMJ)

Choices in health care spendingTo the Editor. It is encouraging that the US Medical Director ofa major drug company endorses the concept of 'accountabilityfor reasonableness' .' However, the company's position cannotbe accepted uncritically. Drug companies often emphasise cost-effectiveness analyses as the primary factor in decidingwhether or not a new drug is 'affordable' . Thus the drugcompany promoting an expensive new product asserts, as inthe case of Xigris, that the cost of just under US$50 000 perquality-adjusted life-year saved compares favourably withother procedures (e .g . kidney transplantation) .In our editorial' we rejected a narrow, technically orientatedapproach . We argued that although highly technical proceduressuch as calculations of cost-effectiveness and estimates of life-years saved are necessary, this must not be the only factorconsidered in making allocation choices. A decision about howto spend society's limited medical resources is a valuejudgement that specifies and balances all morally relevantfactors - including distributive justice, social utility andeconomic efficiency - without giving any single one an a prioriadvantage.' In the case of an expensive new drug such asXigris society may, when forced to make a tough choice,reasonably decide that its moral values compel saving orextending the lives of identifiable patients - say those afflictedwith HIV/AIDS or patients who may be cured with a kidneytransplant - rather than the few who could be saved bypaying an equivalent amount to treat 16 patients in order tosave one unidentifiable life .Cost-effectiveness analyses based on US dollars are largelyirrelevant to South Africa and other developing countries . TheUS alone spends more than 50% (US$1.2 trillion - 14% GDP,with per capita expenditure of almost $5 000) of the total healthcare expenditure in the world on 5% of the world's population .In contrast, South Africa spends about 8.1 % of GDP on healthcare, with a public sector health services budget of US$3.4billion in 2000/01 - about 4% of GDP, amounting to R779 perperson (approximately $100 per capita) . South Africa ranks 94on the Human Development Index, not far above Zimbabwe at117 . South Africa's health administrators must be very selectiveabout what they learn positively from recommendations fromthe US, and there is much negative that we can learn fromthem . Drugs that are affordable as a matter of course in the USand other rich nations may not be relevant or affordable in ourcontext.Debate such as has occurred in this and the previous issue ofSAMJ should be encouraged . However, the discussion must becarried forward in full recognition by all stakeholders of thestark realities that face health administrators in South Africa .Demands for health services have increased exponentially, andthe capacity of the public sector to proved decent qualityservices to all citizens has shrunk. The AIDS pandemic willJuly 2003, Vol . 93, No . 7 SAMJexacerbate an already critical situation . It is in this context thatour health administrators must assess the claims of drugcompanies and manufacturers, often based on data and cost-effectiveness analyses more relevant and useful in the richcountries of the developed world than in developing countrieslike South Africa .S R BenatarT E FleischerBioethics CentreUniversity of Cape Town1.	Macias WL, LevyH. Thevalueof innovation (Debate) . S Afr Med 12003; 93: 502-503 (thisissue).2. BenatarSR, Fleischer TE .New treatments: costs, benefits and decision-making Procedures(Editorial) . SAfr Med12003; 93: 433-434 .3. BeauchampT, Childress J . Principles of Biomedical Ethics . 5th ed . Oxford: Oxford UniversityPress, 2001 .Drotrecogin alfa (activated) inSouth African private hospitalICUsTo the Editor: We wish to comment on the article by Taylorand Burns .' They advance several concerns with the PROWESStrial of drotrecogin alfa (activated protein C) (DroAA) in severesepsis' as reasons for withholding this agent from patientscovered by their medical scheme in South Africa . Theseconcerns may be valid and have been extensively debated atboth local and international congresses . However, the fact isthat DroAA is accepted by the FDA in the USA and regulatoryauthorities in Europe as an effective treatment of severe sepsis.Bleeding complications are an inherent risk of all drugs withanticoagulant activity, including heparins, warfarin andantiplatelet agents . Excess bleeding in trial patients has notprevented various anticoagulants from being used in thetreatment of thrombotic disorders such as acute myocardialinfarction and deep-vein thrombosis, especially withpulmonary embolisation. Healthy debate follows theintroduction of any new intervention in medical practice butcannot be cited by funders, whose primary concern is financialrather than clinical, as an excuse to withhold even expensivetreatment from deserving patients . By the current standards ofevidence-based medicine, DroAA is an acceptable agent fortreatment of severe sepsis .DroAA is particularly important in the treatment of patientswith meningococcal septicaemia,' in which situation it wasavailable on compassionate grounds throughout the worldbefore release . Should the agent be withheld from patients withmeningococcal septicaemia, the risk of complications isdramatically increased and mortality and length of stay in theICU and in hospital are increased . The cost of the agent in thissetting will be more than offset by the reduced need for ICUand hospital care, as demonstrated by a recent case inKwaZulu-Natal. Funders will have to assume responsibility formorbidity and mortality of patients with meningococcalsepticaemia for whom they choose to deny treatment withDroAA.DroAA has been used in South Africa to treat patients withsevere sepsis whoare potentially salvageable but failing toimprove or deteriorating despite best supportive care . Theproviso that patients be deteriorating is a pragmatic stancetaken by intensivists in South Africa to make sure that only themost deserving patients receive the agent. These patients arealso required to meet the inclusion and exclusion criteria forthe PROWESS trial' Best supportive care will includeappropriate source control and inotropes, lung protectiveventilation, insulin and steroids as appropriate, nutrition,infection control, appropriate antibiotics and high-qualitynursing care .' This care is best supervised by an intensivist .Despite the assertion of Taylor and Burns that there is ashortage of intensivists in South Africa, the undersigned allprovide intensivist services in private hospitals throughoutSouth Africa . We do not only care for our own patients but areavailable to provide advice to non-intensivist colleagues . Weare all deeply aware of the impact that excessive andinappropriate use of DroAA will have on funders such asMedscheme. However, the fear of this use has not been borneout by clinical practice under intensivist supervision . None ofthe undersigned has treated more than three patients with APCsince its release 8 months ago. Given the cost of otherinterventions such as cancer chemotherapy and coronarybypass surgery this hardly seems excessive or likely to impactsignificantly on Medscheme'' ability to provide care for itsbeneficiaries . We would like to appeal to Medscheme and otherfunders that DroAAnot be withheld from patients deemedappropriate by intensivists .RE HodgsonPO Box 50247Musgrave4062PG WilliamsPOBox 5562Weltevreden Park1715A P Foden236 Panorama Medi-ClinicPanoramaCape TownD GrolmanSuite 29Sandton Medi-ClinicBryanstonJohannesburgJuly 2003, Vol. 93, No . 7 SAMJ1 .	Taylor B, Bums D. Should health care money in South Africa be spent on drotrecogin alfa? SAfrMed 12003;93: 500-501 (thisissue) .2. BernardGR, Vincent JL, Laterre FF, et al . Efficacy andsafety of recombinant humanactivatedprotein C forsevere sepsis. NEngl J Med2001 ; 344 (10) : 699-709 .3. Faust SN, Levin M, Harrison OB, et al . Dysfunction of endothelial protein C activation insevere meningococcal sepsis. N Engl 1Med 2001 ; 34(9) : 408-016.4. Sollet J-F, Garber GE . Selecting patients with severe sepsis for drotrecogin alpha (activated)therapy. Am J Surg 2002; 184(S): 11S-18S.5. VincentJL,Abraham E, Annane D, Bernard G, Rivers E, Van den BergheG. Reducingmortality in sepsis : New directions. Crit Care 2002; 6(S3) : SI-18.Nocturnal enuresis guidelinesTo the Editor. The authors and Ferring are to be congratulated ontheir efforts in producing a useful document to aid practitionersin the management of nocturnal enuresis and to publicise the factthat treatment is widely available.'However, I feel it is inappropriate to condemn the use oftricyclic antidepressants in the treatment of this condition.Caution is understandable, but in my 15 years of treating a largenumber of enuretic children at Red Cross War MemorialChildren's Hospital and in private practice in Cape Town, I haveyet to come across a serious, irreversible side-effect related to theuse of these drugs. It is true that side-effects do occur, andpatients have to be counselled . It is also true that overdosagewith desmopressin (DDAVP) can result in fluid overload andhyponatraemia, a potentially lethal side-effect.One side-effect of DDAVPcompared with imipramine, whichthe authors did not mention, is that of impoverishment . Isurveyed three local pharmacies and found the average price of amonth's supply of DDAVP0.2 mg tablets to be 8710.92 comparedwith 8105.00 for Tofranil 25 mg and 829.26 for an imipraminegeneric . Most families would find it difficult to find R700 permonth to spend on treatment of what is, in the authors' ownwords, a non-lethal disorder, even for a limited period.Concerning the enuresis alarm, it is my experience that whilethis certainly is the best treatment, its use requires remarkable.dedication on the part of the parents and the child as well as adegree of insight, understanding and acceptance of the conditionthat unfortunately does not exist in all families. Many parents arestill of opinion that enuresis is caused by laziness or naughtiness,and a harsh and disciplinarian attitude is adopted.Imipramine increases functional bladder capacity andimproves arousal from sleep in response to a full bladder, two ofthe three components of the three-part model of enuresispresented by the authors. It is not a perfect drug, but itnevertheless deserves a place in the management ofmonosymptomatic nocturnal enuresis in South Africa .LDJeeConsultant UrologistRed Cross War Memorial Children's HospitalCape Town1. Van DykJC, Duvenage F, Coetzee LJF, et al . South African guidelines for themanagerrent ofnocturnal enuresis. S AfrMed12003; 93: 338-340.475

Drotrecogin alfa (activated) in South African private hospital ICUs

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Drotrecogin alfa (activated) in South African private hospital ICUs

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