1
466 special responsibility for administration (who are so regularly and unfairly maligned-not least by doctors), would be given a long overdue boost and the Service might be allowed to settle down and adapt in a more revolutionary way. Is it not time for doctors particularly to make themselves heard? They could bring a sense of perspective to the public discussion of the issues involved in organising health care. The Griffiths inquiry is clearly designed to legitimate central reductions in staffing levels that ought to be decided peripherally according to local conditions and taking account of experience in this and other countries. As the Royal Commission put it,5 "... the needs and resources of different parts of the U.K. varied so greatly that centralised planning for all N.H.S. staff would be wholly impracticable". Unit for the Study of Health Policy, Department of Community Medicine, Guy’s Hospital Medical School, 8 Newcomen Street, London SE1 1YR PETER DRAPER 5. Royal Commission on the National Health Service. Report. London: H.M. Stationery Office, 1979: 367. Round the World From our Correspondents United States POTASSIUM SUPPLEMENTS AND UPPER GASTROINTESTINAL TRACT THE findings of McMahon et aLl in New Orleans raised doubts about the safety of solid potassium preparations, especially wax- matrix preparations of potassium chloride. The frequency of mucosal irritation and frank ulcers in the upper gastrointestinal tract of the healthy volunteers was disquieting. The adverse effects of the potassium preparations apparently produced no symptoms. In spite of the large number of patients at possible risk, there have been very few comments. It is reported, however, in the Swedish journal Ldkartidningen2 that the Food and Drug Administration in May, 1982, ordered the drug manufacturers to repeat the McMahon study. It is also said that McMahon’s findings were confirmed in September, 1982, in the so-called Miami study for the high-dosage potassium treatment. Liquid forms of potassium are believed to be preferable to solid preparations in this context, though some patients find them less palatable. In any event, the need for potassium supplementation has been questioned. A recent editorial3 concludes: "Until more data are available we continue to recommend that potassium salts or potassium-sparing diuretics should not be prescribed routinely for diuretic-treated hypertensive patients unless they are also receiving digitalis. In our opinion, such treatment is warranted only for severe potassium depletion or for manifestations that clearly can be related to potassium deficit." Aselton and Jick,4 of the Boston Collaborative Drug Surveillance Program, found no correlation between wax-matrix potassium chloride (in the form of ’Slow-K’) and upper gastrointestinal bleeding. But they did not apparently look for a correlation between diagnosed upper gastrointestinal lesions and potassium medication. On March 2 the drug companies will present their own clinical trials to an F.D.A. advisory committee. If the companies’ data should prove hard to reconcile with those of McMahon et al., the 1 McMahon FG, Ryan JR, Akdamar K, Ertan A. Upper gastrointestinal lesions after potassium chloride supplements: a controlled clinical trial. Lancet 1982; ii: 1059-61. 2. Hansson O Lakartidningen 1982; 79: 4639-40; 1983; 80: 25; 1983; 80: 423. 3. Harrington JT, Isner JM, Kassirer JP Our national obsession with potassium. Am J Med 1982; 73: 155-59. 4. Aselton PJ, Jick H. Short-term follow-up study of wax matrix potassium chloride in relation to gastrointestinal bleeding. Lancet 1983; i: 184. outcome of this meeting may well be inconclusive. As with benoxaprofen, the need for further studies to clarify matters might then postpone a regulatory decision. In these circumstances it seems important that the drug authorities and the companies concerned, in the interest of patients, should recommend doctors to re-evaluate the decisive needs for a potassium supplement and, if the indication is clear, prescribe it as a liquid. TRIAL OF ASPIRIN AND BETA-CAROTENE IN PHYSICIANS RESEARCH workers at Harvard Medical School are engaged in a four-year study of more than 20 000 U.S. physicians to re-examine earlier evidence suggesting that the consumption of aspirin reduces mortality from heart disease and that beta-carotene, an analogue of vitamin A, might break a chain of events leading to the development of cancer. Every other day about 5000 of the doctors take a standard 325 mg aspirin tablet and, on alternate days, a 30 mg beta-carotene capsule. The remaining 15 000 doctors take aspirin and placebo, beta-carotene and placebo, or two placebos. The trial is double- blind. Doctors are asked to submit baseline blood samples. "The doctors are being superb patients themselves," according to Dr Charles Hennekens, the principal investigator and an associate professor of medicine at Harvard. Doctors in the trial range in age from 40 to 75, and they have no history of cancer or heart disease. Among the 50 000 original candidates, the chief reason for exclusion was the information that doctors were already taking aspirin regularly. Some were found to be taking it to reduce their risk of cardiovascular mortality. "This," Dr Hennekens observed, "is based on a presumption of knowledge that we don’t have." On the other hand, he believes that previous aspirin studies collectively show a possible lowered risk of heart disease deaths as high as 20%. "A 20% reduction in the 600 000 heart-attack deaths that occur annually in the United States would have enormous public health implications." " The beta-carotene experiment is based on more than 20 epidemiological studies throughout the world. They indicated a significantly lower risk of various cancers in people with a high consumption of dark green and yellow vegetables, such as spinach, broccoli, Brussels sprouts, carrots, and winter squash. It is possible, Dr Hennekens believes, that a correlate other than beta-carotene, such as dietary fibre, may be the determinant. India PROMOTING ORAL REHYDRATION THERAPY ALTHOUGH recent months have seen some media attention to the use of oral rehydration therapy (ORT) in the treatment of diarrhoea, inappropriate self-prescription of anti-diarrhoeal preparations continues. Participants in a workshop on rational therapeutics last August in Jaipur called for a compulsory warning on all anti-diarrhoeal package inserts and advertising material to the effect that "Medicines are not enough to treat diarrhoea. Oral rehydration is most important." They also proposed that the W.H.O. formula for ORT should be included in these package inserts, accompanied by pictorial instructions on how it should be prepared. Besides trying to educate the public about rational diarrhoea treatment, health and consumer groups have devised a programme to gather information on the effects of commonly sold and prescribed anti-diarrhoeals. The plans include: the collation of information on infant deaths associated with such drugs; the monitoring of sales, advertising literature, and effects of chloramphenicol-streptomycin combination brands; and the recording of any SMON cases. In the past some private practitioners and Government authorities have tended to disregard demands for restrictions on antidiarrhoeal drugs, since, it was argued, no ill-effects had been "reported" in the country. Health activists have pointed out that since there is no organised feedback system and since many prescription drugs are freely sold over-the- counter, ill-effects remain unreported. They expect that documented information on the misuse of various drugs will help them to press more effectively for action by the Health Ministry.

India

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special responsibility for administration (who are so regularly andunfairly maligned-not least by doctors), would be given a longoverdue boost and the Service might be allowed to settle down andadapt in a more revolutionary way. Is it not time for doctors

particularly to make themselves heard? They could bring a sense ofperspective to the public discussion of the issues involved inorganising health care. The Griffiths inquiry is clearly designed tolegitimate central reductions in staffing levels that ought to bedecided peripherally according to local conditions and takingaccount of experience in this and other countries. As the RoyalCommission put it,5 "... the needs and resources of different partsof the U.K. varied so greatly that centralised planning for all N.H.S.staff would be wholly impracticable".Unit for the Study ofHealth Policy,

Department ofCommunity Medicine,

Guy’s Hospital Medical School,8 Newcomen Street, London SE1 1YR PETER DRAPER

5. Royal Commission on the National Health Service. Report. London: H.M. StationeryOffice, 1979: 367.

Round the World

From our CorrespondentsUnited States

POTASSIUM SUPPLEMENTS AND UPPER GASTROINTESTINAL TRACT

THE findings of McMahon et aLl in New Orleans raised doubtsabout the safety of solid potassium preparations, especially wax-matrix preparations of potassium chloride. The frequency ofmucosal irritation and frank ulcers in the upper gastrointestinaltract of the healthy volunteers was disquieting. The adverse effectsof the potassium preparations apparently produced no symptoms.In spite of the large number of patients at possible risk, there havebeen very few comments. It is reported, however, in the Swedishjournal Ldkartidningen2 that the Food and Drug Administration inMay, 1982, ordered the drug manufacturers to repeat theMcMahon study. It is also said that McMahon’s findings wereconfirmed in September, 1982, in the so-called Miami study for thehigh-dosage potassium treatment.Liquid forms of potassium are believed to be preferable to solid

preparations in this context, though some patients find them lesspalatable. In any event, the need for potassium supplementation hasbeen questioned. A recent editorial3 concludes: "Until more dataare available we continue to recommend that potassium salts orpotassium-sparing diuretics should not be prescribed routinely fordiuretic-treated hypertensive patients unless they are also receivingdigitalis. In our opinion, such treatment is warranted only for severepotassium depletion or for manifestations that clearly can be relatedto potassium deficit."Aselton and Jick,4 of the Boston Collaborative Drug Surveillance

Program, found no correlation between wax-matrix potassiumchloride (in the form of ’Slow-K’) and upper gastrointestinalbleeding. But they did not apparently look for a correlation betweendiagnosed upper gastrointestinal lesions and potassium medication.On March 2 the drug companies will present their own clinical

trials to an F.D.A. advisory committee. If the companies’ datashould prove hard to reconcile with those of McMahon et al., the

1 McMahon FG, Ryan JR, Akdamar K, Ertan A. Upper gastrointestinal lesions afterpotassium chloride supplements: a controlled clinical trial. Lancet 1982; ii:

1059-61.2. Hansson O Lakartidningen 1982; 79: 4639-40; 1983; 80: 25; 1983; 80: 423.3. Harrington JT, Isner JM, Kassirer JP Our national obsession with potassium. Am J

Med 1982; 73: 155-59.4. Aselton PJ, Jick H. Short-term follow-up study of wax matrix potassium chloride in

relation to gastrointestinal bleeding. Lancet 1983; i: 184.

outcome of this meeting may well be inconclusive. As with

benoxaprofen, the need for further studies to clarify matters mightthen postpone a regulatory decision. In these circumstances it seemsimportant that the drug authorities and the companies concerned,in the interest of patients, should recommend doctors to re-evaluatethe decisive needs for a potassium supplement and, if the indicationis clear, prescribe it as a liquid.

TRIAL OF ASPIRIN AND BETA-CAROTENE IN PHYSICIANS

RESEARCH workers at Harvard Medical School are engaged in afour-year study of more than 20 000 U.S. physicians to re-examineearlier evidence suggesting that the consumption of aspirin reducesmortality from heart disease and that beta-carotene, an analogue ofvitamin A, might break a chain of events leading to the developmentof cancer. Every other day about 5000 of the doctors take a standard325 mg aspirin tablet and, on alternate days, a 30 mg beta-carotenecapsule. The remaining 15 000 doctors take aspirin and placebo,beta-carotene and placebo, or two placebos. The trial is double-blind. Doctors are asked to submit baseline blood samples."The doctors are being superb patients themselves," according to

Dr Charles Hennekens, the principal investigator and an associateprofessor of medicine at Harvard. Doctors in the trial range in agefrom 40 to 75, and they have no history of cancer or heart disease.Among the 50 000 original candidates, the chief reason forexclusion was the information that doctors were already takingaspirin regularly. Some were found to be taking it to reduce theirrisk of cardiovascular mortality. "This," Dr Hennekens observed,"is based on a presumption of knowledge that we don’t have." Onthe other hand, he believes that previous aspirin studies collectivelyshow a possible lowered risk of heart disease deaths as high as 20%."A 20% reduction in the 600 000 heart-attack deaths that occur

annually in the United States would have enormous public healthimplications."

"

The beta-carotene experiment is based on more than 20

epidemiological studies throughout the world. They indicated asignificantly lower risk of various cancers in people with a highconsumption of dark green and yellow vegetables, such as spinach,broccoli, Brussels sprouts, carrots, and winter squash. It is possible,Dr Hennekens believes, that a correlate other than beta-carotene,such as dietary fibre, may be the determinant.

India

PROMOTING ORAL REHYDRATION THERAPY

ALTHOUGH recent months have seen some media attention to theuse of oral rehydration therapy (ORT) in the treatment of

diarrhoea, inappropriate self-prescription of anti-diarrhoeal

preparations continues. Participants in a workshop on rationaltherapeutics last August in Jaipur called for a compulsory warningon all anti-diarrhoeal package inserts and advertising material to theeffect that "Medicines are not enough to treat diarrhoea. Oralrehydration is most important." They also proposed that theW.H.O. formula for ORT should be included in these packageinserts, accompanied by pictorial instructions on how it should beprepared.

Besides trying to educate the public about rational diarrhoeatreatment, health and consumer groups have devised a programmeto gather information on the effects of commonly sold andprescribed anti-diarrhoeals. The plans include: the collation ofinformation on infant deaths associated with such drugs; the

monitoring of sales, advertising literature, and effects of

chloramphenicol-streptomycin combination brands; and the

recording of any SMON cases. In the past some privatepractitioners and Government authorities have tended to disregarddemands for restrictions on antidiarrhoeal drugs, since, it wasargued, no ill-effects had been "reported" in the country. Healthactivists have pointed out that since there is no organised feedbacksystem and since many prescription drugs are freely sold over-the-counter, ill-effects remain unreported. They expect thatdocumented information on the misuse of various drugs will helpthem to press more effectively for action by the Health Ministry.