- Email: [email protected]
UNWANTED DRUG EFFECTS: WHOSE RESPONSIBILITY?
21
clarification of the law on pregnancy termination and the general availability of amniocentesis, has given genetic counsellors the confidence to go out into the community, though there are few instances yet where true screening is possible. The unit at Guy’s (now the SouthEast Thames Regional Genetics Centre) started work in 1960, so its experience2 will be invaluable to those planning or thinking of working in similar services.
Exciting though developments in the prenatal diagnosis of metabolic-error diseases have been-and the Guy’s team offers a service for forty of them-the laboratory workload is dominated by chromosome studies, done on grounds of maternal age or because of a history suggesting increased risk, and by measurement of et-fetoprotein (AFP) in amniotic fluid. Of 2136 referrals from amniocentesis in a little over seven years 822 were for maternal age, 414 for other predicted increased risks of a chromosome disorder, and 740 for neural-tube defects (NTD); only 109 were for inborn errors of metabolism. All this could change: the NTD programme has an upper limit to its workload dictated largely by the birthrate, there would be fewer referrals for trisomies D if women completed their families at a younger age, and other work could grow with developments in direct access to fetal blood and in research on the more common biochemical defects such as cystic fibrosis and haemophilia. Indeed the Guy’s figures for 1977 suggest that amniocentesis referrals for inborn metabolic errors are
already increasing (to one a month).
problems have been those posed others have found, by bloodby mosaicism, and, stained amniotic fluids. A logistic difficulty that all such The main technical
as
services face is whether or not to measure AFP on all amniotic fluids, for whatever reason they have been sent, and to attempt karyotyping on fluids referred from an NTD programme. The Guy’s cytogeneticists quickly found that they could not cope with routine karyotyping of NTD material while routine AFP measurement is less demanding. The main question that a planner will ask-namely, how well is the need for counselling in the South-East Thames region being met by the present service--cannot be answered, except for that dictated by maternal age. However, rough calculations should be produced for possible with the aid of incidence figures 3 the Clinical Genetics example, by Society 3
UNWANTED DRUG EFFECTS: WHOSE RESPONSIBILITY?
Now that the Department of Health and Social Security has woken up to the fact that the general election is over, its consultative document on product liab-ility in the medical sector can be added to the pile of published material on this-vexed topic. There is a move 2. Polani PE, Alberman E, Alexander BJ, Benson PF, Berry AC, Blunt S, Daker MG, Fensom AH, Garrett DM, McGuire VM, Fraser Roberts JA, Seller MJ, Singer JD. Sixteen years’ experience of counselling, diagnosis, and prenatal detection in one genetic centre: progress, results, and prob-
lems. J Med Genet 1979; 16: 166-175. 3. The provision of services for the prenatal diagnosis of fetal the United Kingdom. London: Eugenics Society, 1978.
abnormality
in
Europe, nationally and internationally, to make manufacturers "strictly liable" for their products-in other words, users can sue if a product harms them, without having to prove that the producer was negligent. Drugs differ from other products in that if they perform the function for which they are advertised and prescribed, and even if they fail, they are also likely to be harmful, sometimes predictably and sometimes not. There is no need to turn to chemotherapy of malignant disease for examples of benefit/harm ratios very different from those that would be tolerated for, say, a stepladder or a high-bonding instant glue. The D.H.S.S. document recognises the difficulties, but its message is that neither the drug industry nor the medical and pharmaceutical professions can expect to be exempted. in
Two questions are crucial. The first is the issue of developmental risk (the industry is not trying to evade responsibility for preparations that have been badly made). The Pearson report, the Strasbourg Convention, and the Law Commissions agree that development risk
be allowed as a defence in a suit for strict D.H.S.S. adds that "It appears most unthe liability: likely that any derogation from this recommendation would be politically acceptable". The Association of the British Pharmaceutical Industry, in its comments on the consultative document, repeats its suggestion that a State fund be set up out of which anyone with proof of injury from any product, pharmaceutical or otherwise, could be compensated. The State could then sue the manufacturers for reimbursement if negligence was alleged and the taxpayer would thus be left to foot the bill for injuries of practolol (and, probably, thalidomide) type. However, many people would find such a scheme unacceptable, whether they regard State involvement in this area as a safety net or as an umbrella. The A.B.P.I. wants the scheme further discussed, leaving open the question of funding, presumably a reference to some form of producer/consumer insurance. The second question arises from one of the defences that the drug industry would be allowed-namely, that the adverse effect was one warned against. It is here that doctors are involved for they are not likely to be willing to discuss in detail all the information on adverse reactions that the drug manufacturers may publish. Some form of liability might thus pass to them. should
not
The consumer movement has been a powerful force in the past twenty years or so. It is in the movement’s name and with its support that legislation on product liability is now being considered in the assemblies of Europe. Exemption for the drug industry will be politically unacceptable only if consumers say so, and it is not too late for them to recognise that therapeutics is a chancy business; when things go wrong no-one may be to blame and the taxpayers’ responsibility should stop at welfare support where disability, whatever the cause, warrants it. As the A.B.P.I. points out, the European Parliament has lately altered a draft E.E.C. directive so that product liability is removed if "the article could not have been regarded as defective in the light of the scientific and technological development" at the time when the product was first sold. The fate of that amendment will be closely watched.
clarification of the law on pregnancy termination and the general availability of amniocentesis, has given genetic counsellors the confidence to go out into the community, though there are few instances yet where true screening is possible. The unit at Guy’s (now the SouthEast Thames Regional Genetics Centre) started work in 1960, so its experience2 will be invaluable to those planning or thinking of working in similar services.
Exciting though developments in the prenatal diagnosis of metabolic-error diseases have been-and the Guy’s team offers a service for forty of them-the laboratory workload is dominated by chromosome studies, done on grounds of maternal age or because of a history suggesting increased risk, and by measurement of et-fetoprotein (AFP) in amniotic fluid. Of 2136 referrals from amniocentesis in a little over seven years 822 were for maternal age, 414 for other predicted increased risks of a chromosome disorder, and 740 for neural-tube defects (NTD); only 109 were for inborn errors of metabolism. All this could change: the NTD programme has an upper limit to its workload dictated largely by the birthrate, there would be fewer referrals for trisomies D if women completed their families at a younger age, and other work could grow with developments in direct access to fetal blood and in research on the more common biochemical defects such as cystic fibrosis and haemophilia. Indeed the Guy’s figures for 1977 suggest that amniocentesis referrals for inborn metabolic errors are
already increasing (to one a month).
problems have been those posed others have found, by bloodby mosaicism, and, stained amniotic fluids. A logistic difficulty that all such The main technical
as
services face is whether or not to measure AFP on all amniotic fluids, for whatever reason they have been sent, and to attempt karyotyping on fluids referred from an NTD programme. The Guy’s cytogeneticists quickly found that they could not cope with routine karyotyping of NTD material while routine AFP measurement is less demanding. The main question that a planner will ask-namely, how well is the need for counselling in the South-East Thames region being met by the present service--cannot be answered, except for that dictated by maternal age. However, rough calculations should be produced for possible with the aid of incidence figures 3 the Clinical Genetics example, by Society 3
UNWANTED DRUG EFFECTS: WHOSE RESPONSIBILITY?
Now that the Department of Health and Social Security has woken up to the fact that the general election is over, its consultative document on product liab-ility in the medical sector can be added to the pile of published material on this-vexed topic. There is a move 2. Polani PE, Alberman E, Alexander BJ, Benson PF, Berry AC, Blunt S, Daker MG, Fensom AH, Garrett DM, McGuire VM, Fraser Roberts JA, Seller MJ, Singer JD. Sixteen years’ experience of counselling, diagnosis, and prenatal detection in one genetic centre: progress, results, and prob-
lems. J Med Genet 1979; 16: 166-175. 3. The provision of services for the prenatal diagnosis of fetal the United Kingdom. London: Eugenics Society, 1978.
abnormality
in
Europe, nationally and internationally, to make manufacturers "strictly liable" for their products-in other words, users can sue if a product harms them, without having to prove that the producer was negligent. Drugs differ from other products in that if they perform the function for which they are advertised and prescribed, and even if they fail, they are also likely to be harmful, sometimes predictably and sometimes not. There is no need to turn to chemotherapy of malignant disease for examples of benefit/harm ratios very different from those that would be tolerated for, say, a stepladder or a high-bonding instant glue. The D.H.S.S. document recognises the difficulties, but its message is that neither the drug industry nor the medical and pharmaceutical professions can expect to be exempted. in
Two questions are crucial. The first is the issue of developmental risk (the industry is not trying to evade responsibility for preparations that have been badly made). The Pearson report, the Strasbourg Convention, and the Law Commissions agree that development risk
be allowed as a defence in a suit for strict D.H.S.S. adds that "It appears most unthe liability: likely that any derogation from this recommendation would be politically acceptable". The Association of the British Pharmaceutical Industry, in its comments on the consultative document, repeats its suggestion that a State fund be set up out of which anyone with proof of injury from any product, pharmaceutical or otherwise, could be compensated. The State could then sue the manufacturers for reimbursement if negligence was alleged and the taxpayer would thus be left to foot the bill for injuries of practolol (and, probably, thalidomide) type. However, many people would find such a scheme unacceptable, whether they regard State involvement in this area as a safety net or as an umbrella. The A.B.P.I. wants the scheme further discussed, leaving open the question of funding, presumably a reference to some form of producer/consumer insurance. The second question arises from one of the defences that the drug industry would be allowed-namely, that the adverse effect was one warned against. It is here that doctors are involved for they are not likely to be willing to discuss in detail all the information on adverse reactions that the drug manufacturers may publish. Some form of liability might thus pass to them. should
not
The consumer movement has been a powerful force in the past twenty years or so. It is in the movement’s name and with its support that legislation on product liability is now being considered in the assemblies of Europe. Exemption for the drug industry will be politically unacceptable only if consumers say so, and it is not too late for them to recognise that therapeutics is a chancy business; when things go wrong no-one may be to blame and the taxpayers’ responsibility should stop at welfare support where disability, whatever the cause, warrants it. As the A.B.P.I. points out, the European Parliament has lately altered a draft E.E.C. directive so that product liability is removed if "the article could not have been regarded as defective in the light of the scientific and technological development" at the time when the product was first sold. The fate of that amendment will be closely watched.