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the Committee on Safety of Drugs. The Committeeon Safety of Medicines has generated a nine-mansubcommittee on toxicity, clinical trials, and thera-peutic efficacy, and a twelve-member subcommitteeon adverse reactions; further subcommittees on thechemical and pharmaceutical aspects of submissionsand on biological substances are planned.
BELOW THE BELT" THE right spirit-the genuine hygienic instinct "
extolled by Mr. Cutler Walpole 1 is ancient but stillwith us. Our Anglo-Saxon forebears pursued intes-tinal purity with resolve; indeed, an early Leechbookprescribes a " strong drink " guaranteed to " run upand down 11.2 "
Up " is out of fashion, but " down "
still has its devotees.
Purgatives might fairly claim to be the most abusedof medicines. Hypokalaemia is the commonest conse-quence of prolonged and excessive use of purgatives, 3, 4but malabsorption 5,6 ’- and protein-losing gastro-enteropathy have been recorded. Concealed purgativeaddiction may present a difficult diagnostic problem 3,8 8
and, together with surreptitious vomiting,9,10 shouldalways be kept in mind in the investigation of un-explained hypokalxmia. In time the neurogenicplexuses of the colon may become irreparably dam-aged 11 and the colon becomes atonic. The use of
purgatives in anyone with abdominal pain is down-
right dangerous and was shown considerably to
increase the risks of acute appendicitis.12In themselves purgatives are generally innocuous,
although the story has been told of a young man whoswallowed " seidlitz powder " (tartaric acid withsodium potassium tartrate and sodium bicarbonate)without first dissolving it in water: his stomach
exploded with such force that he was thrown againsta wall.13 Hydrophilic colloid purgatives have veryoccasionally caused bolus obstruction.14 Chemically,purgatives have long seemed safe enough, but famili-arity has bred a false sense of security, because oxy-phenisatin acetate, a constituent of several proprietarypurgatives, has now been recognised to cause acutehepatitis with very high serum-transaminase levelsand increased bilirubin and alkaline-phosphataselevels. 15-17 The affected patients had taken the drug
1. Shaw, G. B. The Doctor’s Dilemma. London, 1906.2. Bonser, W. The Medical Background of Anglo-Saxon England;
p. 410. London, 1963.3. Schwartz, W. B., Relman, A. S. J. clin. Invest. 1953, 32, 258.4. Houghton, B. J., Pears, M. A. Br. med. J. 1958, i, 1328.5. French, J. M., Gaddie, R., Smith, N. Lancet, 1956, i, 551.6. Coghill, N. F., McAllen, P. M., Edwards, F. Br. med. J. 1959, i, 14.7. Heizer, W. D., Warshaw, A. L., Waldman, T. A., Laster, L.
Ann. intern. Med. 1968, 68, 839.8. Rawson, M. D. Lancet, 1966, i, 1121.9. Wallace, M., Richards, P., Chesser, E., Wrong, O. Q. Jl Med.
1968, 37, 577.10. Wolff, H. P., Vescei, P., Kruck, F., Roscher, S., Brown, J. J.,
Düsterdieck, G. O., Lever, A. F., Robertson, J. I. S. Lancet, 1968,i, 257.
11. Smith, B. Gut, 1968, 9, 139.12. Bower, J. O. J. Am. med. Ass. 1932, 99, 1765.13. Tanner, N. C. Proc. R. Soc. Med. 1959, 52, 379.14. Souter, W. A. Br. med. J. 1965, i, 166.15. McHardy, G., Balart, L. A. J. Am. med. Ass. 1970, 211, 83.16. Reynolds, T. B., Lapin, A. C., Peters, R. L., Yamahiro, H. S.
ibid. p. 86.17. Pearson, A. J. G., Grainger, J. M., Scheuer, P. J., McIntyre, N.
Lancet, 1971, i, 994.
for many months and many had gradually accumu-lated it through enterohepatic recirculation, but hyper-sensitivity also seems to play a part because rapidbiochemical deterioration has been reported on chal-lenge with a small dose of the drug."
Oxyphenisatin had been used for forty years beforeit was recognised to cause jaundice. Neither simplicitynor years of apparently harmless use guarantee thesafety of a drug. No old friend is beyond suspicion,and many may not be entirely beyond reproach.
TRANSPLANTATION AND THE LAW
THE Bar Council’s report,l3 published this week, is avaluable contribution to discussions on organ trans-
plantation and the law. A leading point it makes is thatthe public at large should be aware of, and be satisfiedwith, the steps which doctors are obliged to take inorder to safeguard the interests of potential donors.In order to remove doubt, a new Organ Transplanta-tion Act should make it lawful for a surgeon to removean organ from a living donor provided that: the livingdonor is over 16 years of age and is not a patientwithin the meaning of the Mental Health Act 1959;the potential donor has himself consented in writing tothe operation; and before so consenting the potentialdonor has been fully advised about the risks of theoperation by a doctor or team of doctors who areacting independently of the doctor or team of doctorswho are treating the recipient, and who is, or one ofwhom is, of at least five years’ standing. Parents shouldnot be entitled to give consent for children under 16.It should be permissible, the report adds, to remove anorgan after death only when the donor has given hisconsent in writing during his lifetime or when thenearest relative whom it is practicable to consult giveshis consent. Consent to removal of an organ afterdeath might conveniently be recorded in a person’sdriving licence; and the application form for a licencemight contain an appropriate question, which it wouldnot be obligatory to answer.The committee which prepared the report recognises
that there are no completely satisfactory methods ofdiagnosing death. " To attempt a legal definition wouldbe at best idle and at worst unnecessarily restrictive."Doctors should try to agree on the criteria, ensuringthat they accord with the ordinary man’s concept ofdeath. The agreed criteria should be published toallay public anxiety. A doctor concerned in transplantsurgery should not be immune from legal proceedings,civil or criminal, but no criminal proceedings shouldbe brought without the consent of the Director ofPublic Prosecutions. The sale of organs for therapeuticpurposes should not be permitted.On the matter of press publicity, the report declares
that distress has sometimes been caused to relatives,the recovery of patients retarded, and hospital staffsput to some trouble. Restrictions on publicity are notrecommended, but the problem should be consideredby the Younger Committee on privacy.
18. Report of Law Reform Committee on the Law relating to OrganTransplantation. Copies (25p each) may be had from the GeneralCouncil of the Bar, Carpmael Building, Temple, London E.C.4.