934

justified or not, that the risk of fatalities and consequent litigationwould increase) unless it were offered protection against unlimitedliability. There is a precedent for this, as Salzman points out: in theearly days of poliovaccine, liability for side-effects was capped byFederal statute.There are already moves in the USA to make clozapine more

easily available. Senator David Pryor of Arkansas has introducedlegislation to reduce Sandoz’s control of the blood monitoringsystem, and it is reported2 that a few advocacy groups have begunlawsuits to force Medicaid to pay the full costs of clozapinetreatment.

1. Salzman C. Mandatory monitoring for side effects: the "bundling" of clozapine.N Engl J Med 1990; 323: 827-29.

2. Time Oct l, p 97.

German and Swiss drugs in developing countries

Developing countries are important markets for multinational drugcompanies. European companies provide 96% of the importedmedicines used in Africa, 58% in Asia, and 49% in Latin America.The consumer movement, led by Health Action International(HAI), has criticised multinational pharmaceutical companies fordrug dumping and misleading drug information. In a recent studylby HAI, the German BUKO Pharma campaign, and the SwissDeclaration of Berne, two doctors compiled and evaluated all drugsproduced or sold by German and Swiss drug companies in 59developing countries. To find out whether the quality of theproduct range had changed they compared, for each country, lists ofsuch products in the country’s drug compendia for 1984 or 1985with those in the compendia for 1988. Using a decision tree, theyclassified drugs as appropriate or inappropriate. Drugs wereclassified as inappropriate for the following reasons-lack of data onefficacy, or uncertainty or controversy over efficacy record;insufficient concentration of the active ingredient in the

preparation; existence of more effective alternatives; for drugs withtoxic effects, the existence of safer and equally effective substitutes;and, for compound preparations, an absence of pharmacologicaljustification for the combination.

In 1984/85, 66% of the 1312 products of German companieswere judged inappropriate, compared with 60% of 1273 products in1988. Most of these drugs were irrational combination products(41 % of the total product range in 1984/85 and 34% in 1988). Forall the other inappropriate groups the range was 2 to 6%. The Swissproduct range (1084 products in 1988) came out slightly better:48% were classified as inappropriate, 28% of all medicines beingirrational combination products. Again, all the other inappropriategroups made up 1 to 6% of the whole product range.The quality of the product ranges of the different companies

varied widely-for instance, in 1988, 65% of Bayer preparationsbut only 21 % of E. Merck drugs were classified as appropriate, andamong the Swiss companies 64% Ciba Geigy’s drugs (includingthose of their affiliated companies) but only 43% of Sandoz’s(including Wander) were so classified. Servipharm (a Ciba Geigycompany operating only in developing countries) was outstanding,with 97% appropriate drugs in its product range. Some smallercompanies such as Schwabe (German) and Robapharm (Swiss) hadno appropriate drug at all.The World Health Organisation’s 5th model list of essential

drugs (EDL) was also used to assess product ranges. Of all Germandrugs 11 % met EDL guidelines in 1984/85 and 12% in 1988. Thecorresponding proportion for drugs from Swiss companies was17% both times.The claim by multinational drug companies that they produce

some drugs not for the home market but to meet special needs indeveloping countries could not be substantiated. Of the 423 drugs in1988 (33% of the total range) not included in the Germancompendium Rote Liste, only 29% were judged appropriate,compared with 45% of those in the Rote Liste. Among the Swissdrugs 41 % of those not licensed in Switzerland were appropriate,compared with 58% of the drugs with a licence for sale inSwitzerland or for export. Furthermore, some drugs sold indeveloping countries had lost their licence in the home country

years ago for safety reasons-for instance, phenformin was still

being sold by three German companies in Mexico in 1988.The authors of the study argue that the inadequacy of the drug

laws in West Germany and Switzerland is one of the main reasonsfor the poor therapeutic quality of the product ranges. They addthat the chaotic nature of the drug markets in both countriesweakens the potential value of the certification scheme proposed byWHO to protect developing countries against the impon of uselessor even dangerous drugs.

1. Robert Hartog, Hermann Schulte-Sasse. German and Swiss drug supplies to theThird World—survey and evaluation of pharmacological rationality. ZunchErklärung von Bern, 1990. SFr 25. Obtainable from EvB, Postfach 177, 8051Zunch, Switzerland.

Cerebellar degeneration and gynaecologicalcancer

Paraneoplastic cerebellar degeneration is an unusual remote effectof cancer. When the syndrome occurs in association with

gynaecological cancers the neurological symptoms may appearbefore the underlying tumour is identified. At necropsy there iswidespread loss of cerebellar Purkinje cells, sometimes with

perivascular and leptomeningeal inflammation. Highconcentrations of anti-Yo (anti-Purkinje-cell) antibody have beenfound in such patients, but the antigenic stimulus for this immuneresponse has not been known. Furneaux et al,’ however, haveidentified 10 patients with paraneoplastic cerebellar degenerationand breast, ovarian, endometrial, or fallopian cancer in whomPurkinje cell antigens were expressed in tumour cells; these antigenswere not found in 21 controls with ovarian or breast cancer who didnot have neurological deficits. The functions of the Yo antigens areunclear, and a possible direct neurotoxic or neuromodulating effectcannot be ruled out. However, the authors suggest that

paraneoplastic cerebellar degeneration may be an immune

phenomenon in which the antibodies attack the CDR 62 Purkinjecell protein-an "anti-onconeural" immune response, as describedfor myasthenic syndrome, sensory neuronopathyencephalomyelitis syndrome, or retinopathy in association withsmall-cell lung cancer. But what causes expression of these antigensin the tumour cells, and why do these antigens provoke such astriking antibody response?

1. Furneaux HM, Rosenblum MK, Dalmau J, et al. Selective expression of Purkinje-cellantigens m tumour tissue from patients with paraneoplastic cerebellar

degeneration. N Engl J Med 1990; 322: 1844-51.

Who am I?

Confusion and conflict continue to surround the HumanFertilisation and Embryology Bill, now in the report stage in theHouse of Commons. Both supporters and antagonists of the Billagree that the Bill, as it stands, is ambiguous and inadequate. Eachside argues that the issues need to be clarified before the Billbecomes law, although they do not necessarily agree on the directionsuch clarification should take.Donor anonymity still remains one of the most sensitive

questions. Should a child created through artificial fertilisation

techniques have the right to know the identity of his genetic father.or should the donor’s wish to remain anonymous take precedence%The important and complex issue of identity for adopted people orchildren born through human fertilisation techniques is discussedin a book published by the British Agencies for Adoption andFostering.l The authors draw a parallel between the experience ofadopted children and their families, and the dilemma that facesfamilies created through human fertilisation techniques. The!argue that the lessons learned over the past sixty years throughadoptive practices could provide the basis for informed debateabout the consequences of access to information on genetic engineand the loss of donor anonymity.The authors claim that the principle of right to information s

now an integral part of adoption practice. They say that reseaxrshows that adopted adults want more information and actively