Pharmacoeconomics: the truth

Pharmacoeconomics: the truth

1097 1. Emergency Cardiac Care Committee and Subcommittees, American Heart Association. Guidelines for cardiopulmonary resuscitation and emergency ca...

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1. Emergency Cardiac Care Committee and Subcommittees, American Heart Association. Guidelines for cardiopulmonary resuscitation and emergency cardiac care. JAMA 1992; 268: 2171-95. 2. Gilston A, Resnekov L. Cardiorespiratory resuscitation. London: Heinemann Medical Books, 1971. 3. Gilston A. Cardiopulmonary resuscitation. In: Tinker J, Zapol WM, eds. Care of the critically ill, 2nd ed. London: Springer Verlag, 1992: 189-216.

Ambivalent views of Japanese over re-election of WHO director-general SIR,The re-election of Dr Hiroshi Nakajima by the World Health

Organization’s Executive Board for a second term as directorgeneral and irregularities reported in that election have increased the turmoil in that organisation. A vote on the board’s recommendation

expected on May 5 at the World Health Assembly but Dr Nakajima’s integrity is still being questioned in western medical journals and international mass media. Recently, criticism of him has also appeared in the Japanese press. Those Japanese who know is

WHO best-the 120 who have worked for the organisation (including alumni about half are from the government sector)-feel bitter yet ambivalent about this negative news campaign. These people joined WHO with feelings of pride, idealism, and humanity, and for the Japanese who care about WHO, the recent reports about scandals and mismanagement have caused both dismay and anger. These Japanese insiders understand that Nakajima himself and his management style have contributed but they also recognise that WHO’s problems have much deeper structural and ideological roots. Because the policy of the Japanese Government is to back Nakajima, Japanese supporters of WHO have felt constrained from action, even though they feel very uneasy. Most choose silence as the best tactic and a sign of their loyalty to their government. A few Japanese staff dared to advise their government not to support Nakajima; their advice was not taken and their courage has ruined their relations with the government. Japanese staff in WHO have had to face an uneasy loyalty test-to stand for the cause of WHO or for the cause of their government? As a Japanese from academia (not government) who served under Nakajima for almost five years at the WHO Regional Office for the Western Pacific in Manila I share this ambivalance. I agree that he lacks certain communication and management skills, a clearly articulated world vision, and a respectable personality but I am concerned that the negative news reports have gone beyond the limits of ethical journalism. In Manila I had to swallow Nakajima’s seemingly illogical instructions on several occasions. At first I thought that this was because of the unorthodox nature of the programme I handled-namely, traditional medicine, which draws on the sometimes illogical but experienced wisdom of Eastern culture-but gradually I learned that his instructions were difficult to understand, not because of his "Japanese" style, but because of his personality mingled with his long residence in the west. Despite Nakajima’s leadership, the regional office in Manila survived because dedicated and capable staff members supported him in an Asian way, trying to patch up his mistakes and shortcomings. In Asia decisions are by consensus and the top man is not expected to make real decisions. The criticism of Nakajima in western media has created some sympathy for him in Japan. Even Japanese who know his weaknesses feel like defending him and the attacks are creating support for him in the Japanese Government and among Japanese citizens. Many people are coming to believe that the criticisms are motivated by a combination of anti-Japanese feelings and the vestiges of white colonialism. The campaign against Nakajima suggests that the patterns of confrontation, miscommunication, and manipulation in economic trade conflicts between Japan and the west are being repeated in WHO. This is unfortunate, for WHO and for its intended beneficiaries. To restore morale and a sense of mission to WHO, all parties (Japan, USA, European Community, and third world countries) should start talks aimed at stopping the nonsensical fighting in the press and fmding a reasonable compromise. Department of Clinical Pharmacology,

Division of Information Medicine, Medical Research Institute, Tokyo Medical and Dental University, Tokyo 101, Japan

KIICHIRO TSUTANI

Would you sign your criticism? SIR,-In your March 20 issue you published a statement of the "Vancouver group" (p 742) calling for declaration of conflicting interests from authors, reviewers, and editors of scientific

publications. I think that with the current system of peer review some of the points raised are rather hypothetical. As long as a paper about the cell biology of yeast is reviewed by a yeast cell biologist-who to all of us will seem more appropriate than a particle physicist-it is hard to see how the referee, without brainwashing, can live without using his knowledge, be it consciously or unconsciously. Who would go on sequencing a specific gene, knowing that the sequence data are "in press"? The real question in such a case will be whether the authors get a fair judgment. Two general rules might help. First, editors should not accept unsupported statements from referees, such as "similar results have been reported before". Second, two expert opinions should be obligatory and assessed by the editor. What might help much more is a complete reversal of the system: the authors should be anonymous to the referee, since the latter should only review the manuscript and not the authors or their institutions. The referee, however, should be known not only to the authors, but-in case of acceptance and if he has recommended publication-also to the public. This acknowledgement could be done as footnotes, a similar procedure being used by some journals for personal communications, and might simultaneously improve the quality of submitted papers. As the referee shares part of the responsibility in publications, he will do his job very thoroughly and he might be rewarded for that by being known as a referee of good papers. Would the authors really be anonymous? Certainly not, if they identify themselves by their citations. An additional advantage of the proposed system is that it would encourage correct and unbiased citations. And would the referees still be protected from "revenge" by an author whose article is rejected? I do not see a reason for hard feelings, if the criticism has been explained, supported, and thereby made agreeable. The system of peer review still serves us very well. It has, however, been established at a time when publications did not have such a direct impact and feedback on careers and future financial support (extramural funding or intramural rating). Since publication records are no longer a question of mere honour, it might be time to reconsider modifications. As long as we live with the present procedure it might help if the referees ask themselves about their comments: "Would you sign them?" Institut fur Humangenetik der Universitat, D-3400 Gottingen, Germany

JOCHEN REISS

Pharmacoeconomics: the truth SIR,-We were disappointed by the overall cynicism in your March 20 note, which attempted to dispose of pharmacoeconomics as a "growth industry", enthusiasm for which is "due to industry’s defensive concern about their large demand on NHS resources". In fact pharmacoeconomics is a discipline that seeks to ensure that every pound spent on treatment buys as much good as possible. Being committed to this philosophy, we would like to dispel some common misconceptions about pharmacoeconomics. Pharmacoeconomics is neither new nor a fad. The methodology has been developing for at least 20 years1 and is merely the application of economic analysis to medical treatment. Published work contains many excellent guides to the interpretation and conduct of pharmacoeconomic analyses and critiques of published papers.2-4 It is true that there are flaws in the design of most studies, but this is so throughout medical publications. The dangers of bias in pharmacoeconomics studies sponsored by the pharmaceutical industry have been addressed.s Our policy follows that advocated by Hillman et a 15 in drawing up clear, contractual obligations about publication before embarking on a study. On the two occasions that major prospective studies did not support a company’s product, we have not encountered opposition to publication of full results,6,7 but we are nonetheless aware of colleagues who have come under pressure not to publish adverse

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results of kinetic or clinical studies. This human weakness should be acknowledged and resolved before a study starts. Moreover, critics of the pharmaceutical industry would do well to remember that fraud and deceit in science owes more to the lust for academic advancement than to commercial pressures.8 Broad and Wade" were prompted to write their book after seeing the complacency of the medical profession when faced with a case of scientific fraud. At least pharmacoeconomists acknowledge the possibility of bias and are developing methods to ensure that it is avoided or kept to a minimum. The pharmaceutical industry is no more or less prone to human frailty than any other group under intense pressure to produce positive results. Economics is a rigorous discipline that seeks to make explicit the assumptions and value judgments that are part of every decision. There is much evidence to support Maynard, who you cite as saying that there is no scientific basis for much medical care.9,10 Unfortunately, when threatened by evidence of the shaky basis of medical practice, some doctors seek to restore the illusion that all is well by attempting to discredit critics of the status quo. We trust that your readers will not be too influenced by such arguments and will learn to appreciate the discipline of pharmacoeconomics. Department of Management, Pharmacoeconomic Research Centre, University of St Andrews, St Andrews, Fife KY16 9DJ, UK

PETER DAVEY MOMALEK TIM DODD

1. Weinstein MC, Stason WB. Foundations of cost-effectiveness

analysis for health and medical practices. N Engl J Med 1977; 296: 716-21. 2. Detsky AS, Naglie IG. A clinician’s guide to cost-effectiveness analysis. Ann Intern Med 1990; 113: 147-54. 3. Lee JT, Sanchez LA. Interpretation of "cost-effective" and soundness of economic evaluations in the pharmacy literature. Am J Hos Pharm 1991; 48: 2622-27. 4. Udvarhelyi IS, Colditz GA, Rai A, Epstein AM. Cost-effectiveness and cost-benefit analyses in the medical literature. Are the methods being used correctly? Ann Intern Med 1992; 116: 238-44. 5. Hillman AJW, Eisenberg JM, Pauly MV, et al. Avoiding bias m the conduct and reporting of cost-effectiveness research sponsored by pharmaceutical companies. N Engl J Med 1991; 324: 1362-65. 6. Davey P, Duncan ID, Edward D, Scott AC. Cost-benefit-analysis of cephradine and mezlocillin prophylaxis for abdominal and vaginal hysterectomy. Br J Obstet Gynaecol 1988; 95: 1170-77. 7. Lynch W, Davey P, Malek M, Byrne DJ, Napier A. Cost-effectiveness-analysis of the use of chlorhexidine detergent in whole body disinfection in wound infection prophylaxis. J Hosp Infect 1992; 21: 179-91. 8. Broad W, Wade N. Betrayers of the truth: fraud and deceipt in the halls of science. New York: Touchstone, Simon & Schuster, 1983. 9. Smith R. Where is the wisdom... ? The poverty of medical evidence. BMJ 1991; 303: 798-99. 10. Anderson TF,

Mooney G. Medical practice variations: Where are we? In: Anderson TF, Mooney G, eds. The challenges of medical practice variations, Basingstoke: Macmillan Press, 1990P 1-15.

Surgical instruments and disease transmission SIR,-A letter from the Department of Health, England and Wales, dated Dec 7, 1992, on "Neuro and ophthalmic surgery procedures on patients with or suspected to have, or at risk of

developing Creutzfeldt-Jakob Disease (CJD), or GerstmannStraussler-Scheinker Syndrome (GSS)" recommends that instruments not normally regarded as disposable should under no circumstances be re-used and should be destroyed. There is no evidence that properly processed surgical instruments transmit infection, and the expense of destroying sets of neurosurgical or ophthalmic instruments is unacceptable. Thorough cleaning alone should considerably reduce risks of transmission,l and subsequent autoclaving as previously recommended2,3 at 134°C for 18 minutes (6 routine cycles) should increase safety. Hospital Infection Research Laboratory, Dudley Road Hospital, Birmingham B187QH, UK

G. A.

J. AYLIFFE

JR, Lynam P. Process options for biohazards. J Ster Serv Management 1993; Jan, Feb, March 5-9. 2. DHSS. Management of patients with spongiform encephalopathy (Creutzfeldt-Jakob Disease [CJD]). London: DHSS, 1984 Circular DA (84): 16. 3. Taylor DM. Inactivation of the unconventional agents of scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob Disease. J Hosp Infect 1991; 18 (suppl D): 1. Babb

141-46.

Fewer hospitals, bigger medical schools SIR,-In commenting on the UK government’s response to the Tomlinson recommendations (March 6, p 620), Malcolm Dean states that, in London, "only two postgraduate institutions were thought to be internationally outstanding" as judged by the university committee, which has recently rated research quality. This is incorrect. The latest information on the strength of medical research in the UK comes from the national research assessment exercise by the Universities Funding Council in 1992, and published in December. 14 medical schools won top rankings, equating to international excellence in laboratory sciences, community, and hospital-based subjects. Of these top grades, rated as "internationally outstanding", 8 were awarded to London institutions, and 6 of these to postgraduate schools and institutes. In addition, a further postgraduate institute was awarded the top rating in pharmacology and biological sciences. This national, independent, evidence is powerful support for the postgraduate schools, and for our practice of linking medical research with patient care in specialist hospitals, and with public health medicine in district and regional health authorities. The Tomlinson proposal to group medical education in London around the big multifaculty colleges makes sense for the preclinical phase of undergraduate medical education. Clinical research, however, increasingly requires a strong scientific base, but that base must be within the hospital and not in a multifaculty college some distance away. Strengthening scientific and academic links with departments of multifaculty colleges is highly desirable, but is no substitute for a framework of highly motivated clinician-scientists and basic scientists working on clinical problems within hospitals that have a strong commitment to research. Postgraduate Medical Federation, University of London, British

MALCOLM GREEN

London WC1 N 3EJ, UK London School of

Hygiene Tropical Medicine,

and

London

RICHARD FEACHEM

Royal Postgraduate Medical School, London

COLIN DOLLERY

Dimethylsulphoxide and cooling after extravasation of antitumour agents SiR,—Inadvertent extravasation during antitumour therapy with intravenous administration can cause minor erythema to severe necrosis.1 Several antidotes have been tested in animals, but there has been little clinical study.2 It has also been suggested that no treatment should be used at the extravasation site, with the recommendation for early referral to a plastic surgeon for excision of drug-infiltrated tissue and skin grafting.3 We have developed a simple, more conservative policy based on a topical combination of dimethylsulphoxide (DMSO) and local cooling. DMSO, an anti-inflammatory easily absorbed percutaneously, prevented ulcerations after anthracycline extravasations in an open clinical study,’ probably because of its free-radical scavenging properties. In addition, local cooling protects against anthracycline skin toxicity, while warming seems to be harmful. Our combined schedule of immediate intervention after extravasations tries to reduce patients’ discomfort and nursing time. 99% DMSO (Sigma), is topically applied on and around the extravasation site and left to dry without dressings. The application is repeated three times a day for a week by the patient at home. If erythema persists at the end of the first week, DMSO is continued until complete resolution. Local cooling for 60 min and repeated every 8 h for the first 3 days is obtained with a cryogel (ColdHot Pack 3M Health Care). 41 patients with extravasations of doxorubicin (8 patients), epirubicin (19), mitomycin-C (4), and mitoxantrone (10) have been treated. Only 2 patients required additional care for complications related to their extravasations. 1 who had mitomycin-C extravasated around a subcutaneously implanted port developed painful cellulitis in this area and had to be referred for port removal, with subsequent healing. The other, after complete remission of