international requirements for drug approval

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Page 1: INTERNATIONAL REQUIREMENTS FOR DRUG APPROVAL

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resuscitation is not immediately started, the patientshould have a single dose of 150-200 meq of sodiumbicarbonate during the initial minutes of a cardiac

arrest, guided by acid-base measurements. The NationalConference for Cardiopulmonary Resuscitation hasadvised that two doses of 1-0 meq/kg may be given dur-ing this period, if the circulation is not rapidly restored,followed by 0.5 meq/kg at 10-minute intervals.23

Although Bishop and Weisfeldt8 recorded some adverseeffects with smaller doses in dogs and man, unless car-diac arrest is promptly dealt with when bicarbonate is

unnecessary a reasonable course in an adult is to infuse100 meq at the start of resuscitation whilst maintainingventilation. Larger or repeated doses demand caution.Resistant acidosis may be due to inadequate ventila-tion.24 25

MENSTRUAL REGULATION

THE Law and medical practice with regard to veryearly abortion are such that the physician has greaterfreedom of action in some Latin American countries,such as Panama or Bolivia, than in the United King-dom. Certainly, more cases of the technique known asmenstrual regulation have now been performed in Chilethan in England. Late in March, the Pathfinder Fund,Boston, U.S.A., brought 130 physicians and lawyersfrom 18 Latin American countries to the Airlie Foun-dation, Virginia, to discuss new developments in fertilityregulation. Most of the meeting was devoted to men-strual regulation (M.R.)--evacuation of the uterus,within 10-14 days of the first missed period, by meansof 4 4 or 6 mm flexible Karman cannula and a sourceof suction such as a hand-held 50 ml aspiration syringe. 26M.R. is now practised in about a third of the Latin-American countries. The South American experience inturn grows out of North America. (The Airlie meetingwas co-sponsored by the department of public health,University of Pittsburgh.) In 1975 half of all the preg-nancy terminations in the West Pennsylvania Hospital,Pittsburgh, were performed as M.R.S, most by a nursepractitioner, and only 8% of all terminations were after14 weeks. When Laufe set up the service in 1971 26%were second-trimester operations. Cates, of the U.S.

Department of Health, Education and Welfare,reviewed nationwide U.S. experience with all vacuum

aspiration techniques for first-trimester abortions andreported a death-rate of 1.8 per 100 000 procedures.This is of the same order as W.H.O. and U.S. estimatesof deaths after intramuscular penicillin (1.7 per100 000). For legal abortion in the first 8 weeks of preg-nancy the U.S. (1974) nationwide mortality was 0-4 per100000.At the Airlie meeting M.R. was said to be simple, safe,

and rapid when performed by a no-touch technique,usually without even local anaesthesia. A series of 8000cases with follow-up was reported by the InternationalFertlility Research Program, Chapel Hill, North Caro-lina. There is a slightly higher rate of continuing preg-nancies (approximately 1%) than with vacuum aspira-23. National Conference on Cardiopulmonary Resuscitation. J. Am. med Ass.

1974, 227, (suppl)., 833.24. Chazan, J. A., Stenson, R., Kurland, G. S. New Engl. J. Med. 1968, 278,

360.25. Fillimore, S., Shapiro, M. Killip, T. Ann. intern. Med. 1970, 72, 467.26. Lancet, 1974, i, 84.

tion performed later in pregnancy, and women should betold that repeat operation is occasionally needed. Mostobservers reported a jump in contraceptive use bywomen after an M.R. procedure. No-one recommendedthe method as an alternative to contraceptives.The peoples of Latin America belong to that minority

of the world’s population for whom abortion is illegal-except sometimes for strictly medical reasons. Neverthe-less, estimates of clandestine abortion suggest higherrates, in many Latin American countries, than in Bri-tain. A million women a year are admitted to LatinAmerican hospitals for treatment of incomplete abor-tion. Potentially, menstrual regulation offers an escaperoute from this great public-health problem. Unlike the1861 British abortion law, which made the "intention"to perform an abortion a felony, all Latin American

jurisdictions refer to the abortion of a "pregnantwoman" as a "woman with child". Latin American law-

yers at the meeting agreed unanimously that, unlessthere is proof of pregnancy, whatever the intention ofthe operator uterine evacuation is not a crime. M.R., likeintrauterine-device insertion, falls outside the law.

INTERNATIONAL REQUIREMENTS FOR DRUGAPPROVAL

WITHOUT waiting for the proceedings to be published,the sessional chairmen of a symposium on InternationalCo-operation in Drug Testing have issued a statementwhich has appeared in three pharmacological jour-nals.1-3 The symposium formed a major part of theSecond International Meeting of Medical Advisers in thePharmaceutical Industry, which was held in Florence inOctober, 1975. The statement draws attention to the

ever-increasing demands of the various national healthauthorities for preclinical and clinical data before appro-val is granted for the release of new drugs. The situationis made worse by the inconsistency between countries,and particularly by certain countries that require someof the investigations to be repeated within their ownfrontiers. This can happen even inside the E.E.C. Thestatement points out that this irrational allocation ofscarce resources has undesirable consequences fromseveral points of view. The chairmen recommend thathealth authorities should justify such requirements onscientific and ethical grounds and that, provided a study"has been conducted in conformance with the laws,regulations, and scientific and ethical standards of clini-cal research in the country in which the research wasconducted,"4 it should in principle be acceptable as acontribution to the sum-total of data and judged on itsmerits. They say that, despite formal declarations to thiseffect by important health authorities, the practicalresults are so far very small, and they call for moredetermined efforts by all concerned to increase the inter-national acceptability of drug-registration data.

1. Binns, T. B., Gross, F., Lasagna, L., Nicolis, F. B. Br. J. clin. Pharm. 1976,3, 333.

2. Binns, T. B., Gross, F., Lasagna, L., Nicolis, F. B. Clin. Pharm. Ther. 1976,19, 247.

3. Binns, T. B., Gross, F., Lasagna, L., Nicolis, F. B. Europ J. clin. Pharm.1976, 9, 469.

4. U.S. Federal Register, 40: 16056, April 9, 1975.