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1. Murphy AM, Grohmann GS, Christopher PJ, Lopez WA, Davey GR, Millson RH.An Australia-wide outbreak of gastroenteritis from oysters caused by Norwalkvirus. Med J Aust 1979; 2: 329-33.

2. Gunn RA, Janowski HT, Lieb S, Charlton Prather E, Greenberg HB. Norwalk virusgastroenteritis following raw oyster consumption Am J Epidemiol 1982, 115:348-51

3 Gill ON, Cubitt WD, McSwiggan DA, Watney BM, Bartlett CLR Epidemic ofgastroenteritis caused by oysters contaminated with small round structured virusesBr Med J 1983; 287: 1532-34.

4 Morse DL, Guzewich JJ, Hanrahan JP, et al. Widespread outbreaks of clam-and-oyster-associated gastroenteritis—role of Norwalk virus N Engl J Med 1986; 314:678-81.

5. Sockett PN, West PA, Jacob M Shellfish and public health. PHLS Microbiol Digest1985, 2: 29-35.

6 White KE, Osterholm MT, Mariotti JA, et al A foodborne outbreak of Norwalk virusgastroenteritis: evidence for post-recovery transmission. Am J Epidemiol 1986, 124:120-276

7. Oliver B, Ng S, Marshall J, et al Prolonged outbreak of Norwalk gastroenteritis in anisolated guest house Med J Aust 1985; 142: 391-95.

8 Riordan T, Wills A An outbreak of gastroenteritis m a psychogeriatric hospitalassociated with a small round-structured virus. J Hosp Infect 1986; 8: 296-99

9 Leers WD, Kasupski G, Fralick R, Wartman S, Garcia J, Gary W. Norwalk-likegastroenteritis epidemic in a Toronto hospital. Am J Publ Health 1987; 77: 291-95.

10. Kuritsky JN, Osterholm MT, Korlath JA, White KE, Kaplan JE. A state-wideassessment of the role of Norwalk virus in outbreaks of food-borne gastroenteritis. JInfect Dis 1985; 151: 568.

11. Iversen AM, Gill M, Bartlett CLR, Cubitt WD, McSwiggan DA Two outbreaks offoodbome gastroenteritis caused by a small round structured virus. evidence ofprolonged infectivity in a food handler. Lancet 1987, ii: 556-58.

12. Curry A, Riordan T, Craske J, Caul EO Small round structured viruses and

persistence of infectivity in food handlers. Lancet 1987; ii 864-6513. Thomhill TS, Kalica AR, Wyatt RG, Kapikian AZ, Chanock RM. Pattern of

shedding of the Norwalk particle in stools during experimentally-inducedgastroenteritis in volunteers as determined by immune electron microscopy. JInfect Dis 1975; 132: 28-34

14. Greenburg HB, Wyatt RG, Kapikian AZ Norwalk virus in vomitus. Lancet 1979, i.55

15. Caul EO. Small round human faecal viruses In Patterson J, eds. Parvoviruses andhuman disease. London. CRC Press, 1988: 139-63

16. PHLS Salmonella Sub-Committee Notes on the control of human sources of

gastrointestinal infections, infestations and bacterial intoxications in the United

Kingdom. London Public Health Laboratory Service, 198317 Food Industry Medical Officers’ Working Group Health standards for work in the

food industry, food retailing and in establishments involved in catering J Soc

Occup Med 1987; 37: 4-9.

International Physicians for thePrevention of Nuclear War

NUCLEAR THREAT AND HEALTH IN THEPACIFIC OCEAN

IAN MADDOCKS

215 Brougham Place, North Adelaide 5006, Australia

THE lessons from the Pacific about the health effects ofnuclear testing and weapons development are not those ofthe long-term effects of low-level radiation; rather they tellof how human health is compromised by subtle andunnoticed ecological effects and how social disruption andcultural decay follow in the wake of nuclear strategies.The Pacific Ocean offers attractive prospects for nuclear

powers. Here are compliant island communities occupyingsites very suitable for the testing of nuclear warheads andmissiles. Early assessments of the effects of this activity onthe health of Pacific islanders concentrated on direct

physical damage-such as the effects of fallout from the UStests at Bikini atoll on Marshallese islanders and Japanesefishermen, or the indirect pollution of populationsdependent upon the food chains from reefs and lagoonscontaminated by radioactive substances.A full scientific assessment of these effects is hampered by

the lack of reliable information and the possibility that not alldata have been released. The epidemiology of radiationeffects is notoriously difficult. Rarely is the exposure dose ofradiation accurately known. A high level of security attendsall nuclear tests. Claims by British servicemen who wereexposed to fall-out on Christmas Island and in whomunusual cancers developed many years later are still beingcontested in the courts. From Polynesia very few useful dataare available about the consequences for its peoples and itsislands of the 41 atmospheric and 60 underground tests doneby the French on and around the island of Mururoa. In 1983a scientific mission visited French Polynesia but did notdiscover any increase in cancers or other diseases

attributable to radioactivity.1 These findings were receivedwith scepticism because of the very incomplete informationto which the mission had access, the small size of the

population at risk, and the absence of post-mortem records.From indirect observations of temperature measurementsfrom the lagoon and the surrounding ocean, New Zealandscientists have calculated that significant radioactivecontamination of the Pacific would occur over the next10-100 years, in contrast to the 1000-10 000 years estimated

by French scientists.2 In the Eniwetok atolls, 33 years after a15 mega-ton blast on Bikini atoll the evacuated inhabitantsare still prevented from returning to their homes.3 30 yearsafter the British conducted eight major and many minor testexplosions in the desert regions of South Australia, it wasrecognised that large amounts of highly radioactive

plutonium had been deposited over a wide area-plutoniumhas a half life of 24 400 years. In 1985, a Royal Commissionrecommended that the British Government should clean upthose sites-a task estimated to cost at least US$500million.’ The British Government has not responded to thisrecommendation.

Assessment of the physical effects of radiation is not

enough. We are called, as physicians, to look also at the manyecological, social, and emotional consequences. At theRadiation Effects Laboratory at Hiroshima the

comprehensive and attested data for Hibakusha (A-bombsurvivors) do not include the social effects. Azami,showever, records that many survivors reporteddisadvantage or discrimination in employment, marriage,and education.

Ciguatera poisoning is caused by a toxin produced in theflesh of fish which feed on plankton. In northern Australia,ciguatera poisoning was first noticed after an alumina

refinery was built at the port of Gove in 1972 and has nowbecome endemic off the coast of North Queensland. Thefrequency of ciguatera has been particularly high in the areasof the Marshall Islands and in French Polynesia that havebeen most affected by nuclear tests.6 Because of fear of theeffects of ciguatera poisoning the islanders have abandonedtheir traditional food sources. Many other pressures

stemming from military strategies have contributed to thedestruction of the traditional culture of these people andhave continued their dependent and depressed colonialstatus.

The people of Kwajalein in the Marshall Islands havesuffered as much as those of Eniwetok, not from fallout butby being displaced from their home island and crowded ontonearby Ebeye so that the USA could continue to drop its

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test-fired missiles into the lagoon. Ebeye has become aPacific urban slum; it is overpopulated, its shanties are

teeming with malnourished children, and its adults aredistracted by alcohol and television and reliant uponprocessed imported foods. The Marshallese peopleaccepted this state of affairs because of their dependenceupon US aid even for bare essentials. A people who oncelived successfully in their coral atolls, they now are virtualbeggars in world economic terms. By a "Compact of FreeAssociation" 3 they agreed to allow the continuingoccupation and use of Kwajalein in return for a generousrent.

The policies of France in opposing independent status forits Pacific territories point to a link between nuclear strategyand necessary dependency. But even independence does notpreserve small nations from military exploitation andpressure. On Aug 6, 1985, the thirteen independent nationsof the South Pacific Forum announced a nuclear free zone

covering their region, which bans the stationing, use, andtesting of nuclear weapons within the zone. The failure ofBritain, the USA, and France to ratify that treaty waspredictable since the great powers, in their intrusions overfour centuries, have rarely taken notice of the aspirations orlocal needs of Pacific islanders.

In Europe the demarcation of national boundaries and ofconflicts seems clear, but in the northern Pacific region deepand divisive regional conflicts remain unresolved, territorialclaims are still being contested, and the superpowers postureand challenge in provocative and dangerous ways. Militaryexercises for their own forces and those of their allies growbigger and broader in scope each year.7 There is currentlygreat hope of dismantling nuclear weapons in Europe, but inthe north Pacific there are no negotiations that might in anylike way build confidence, reduce tension, or work towardsbalanced reductions in nuclear forces. The nuclearwarheads stored on Pacific islands and the nuclearsubmarines that cruise unnoticed deep in Pacific waterscarry the same risk to world survival as do their more visible

counterparts in Europe, Asia, and North America.At its seventh congress, International Physicians for the

Prevention of Nuclear War (IPPNW) firmly stated its

policy as abolitionist.8 The new manner of thinking, whichthe nuclear age demands, calls not only for the completeelimination of nuclear weapons, but also for a recognitionthat the Earth is as fragile as a coral atoll, and that all peopleare interconnected and have equal rights to self-determination.

REFERENCES

1. New Zealand Ministry of Foreign Affairs. Report of a New Zealand, Australia andPapua New Guinea scientific mission to Mururoa Atoll. Wellington: New ZealandMinistry of Foreign Affairs, 1984.

2. Hochstein MP, O’Sullivan MJ. Geothermal systems created by underground nucleartesting. Paper presented to the Asian Pacific Regional Symposium of InternationalPhysicians for Prevention of Nuclear War, Auckland, February 10th, 1987.

3. Hayes P, Zarsky L, Bello W. American lake Nuclear peril in the Pacific. MelbournePenguin Books, 1986

4. Robotham R. Maralinga. Paper presented to the Asian Pacific Regional Symposium ofInternational Physicians for Prevention of Nuclear War, Auckland, February 10th,1987.

5. Azami S Current problem of physican handicap and damage in lives of HibakushaPaper presented to Seventh Congress of International Physicians for Prevention ofNuclear War, Moscow, May 31st, 1987.

6 Ruff T. Fish poisoning in the Pacific Paper presented to Asian Pacific RegionalSymposium of International Physicians for Prevention of Nuclear War, Auckland,February 10th, 1987.

7 Mack A. Global and regional superpower policies Paper presented to Asian PacificRegional Symposium of International Physicians for Prevention of Nuclear War,Auckland, February 10th, 1987

8. International Physicians for Prevention of Nuclear War What we believe. Statementfrom the Seventh Congress, A New Manner of Thinking Moscow, June 1st, 1987.

Drug Regulation

EEC SUPRANATIONAL DRUG REGULATORYAUTHORITY BY 1992?

R. D. MANN

Royal Society of Medicine, London W1M 8AE

DISCUSSIONS on a pan-European or supranational drugregulatory body are underway. The extent to which doctorsin the member states of the European Economic

Community (EEC) have been or will be consulted beforecommitments are made is important. On Nov 4, 1987,Robert Hankin, a lawyer and administrator at the

Commission of the European Communities, said, in alecture that has now been published,l that "Thefundamental task for the Commission, and the one on whichthe whole approach to the internal market in the

pharmaceutical sector will be judged, is to arrive at a singlecommon evaluation of medicinal products valid throughoutthe Community." On Feb 10, 1988, Scrip, a publicationwidely read in the pharmaceutical industry, stated that theEuropean Commission had already started talking to

interested parties about the future registration of

pharmaceuticals.2 These discussions would focus on thechoice between mutual recognition of national licensingdecisions or a centralised European body along the lines ofthe US Food and Drug Administration. Either way, drugregistration at a national level as we know it would end.Who are the "interested parties" with whom discussions

have begun? If they include the public, would the public orits elected representatives be content with a change thatwould enormously limit the powers of individual

governments of EEC countries to protect the public healthin the sensitive area of prescription medicines? If theyinclude the medical profession, would doctors (or the publicfor that matter) accept loss of national sovereignty over theintroduction of the 10-50 new drugs that enter the marketeach year? No drug that is effective is entirely safe.

Furthermore, "not all hazards can be known before a drug ismarketed; neither tests in animals nor clinical trials in

patients will always reveal all the possible side effects of adrug. These may only be known when the drug has beenadministered to large numbers of patients over considerableperiods of time". A product licence or marketingauthorisation for a new drug is given on the basis of datafrom 3000 or so patients included in formal clinical trials.No-one can predict the incidence and pattern of the rare andserious adverse effects which might present when the drug isused on perhaps a million patients or more. Hence theimportance to doctors of who gives licences for new drugsand how they are given. Doctors can be sued when things gowrong-and they must depend on the judgment of thelicensing authority. Patients who risk the adverse effects,have an even greater reason to be concerned with this issue.

BACKGROUND

The EEC is committed to an internal market by 1992. Since 1965official directives and recommendations have been adopted which,together with the establishment in 1975 of a multistate procedurefor obtaining marketing authorisations, have led to a usefulrationalisation of data requirements for the licensing of medicines.However, despite this harmonisation, the licensing decisions