NEWS Blood, HIV, and compensation
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It seems likely that in every country where haemophiliacs received blood products between 1980 and 1985 some of them will have been infected with HIV, with the proportion varying according to the prevalence of HIV in the population from which the clotting factors came. Countries (and pharmaceutical companies) vary, too, in how much compensation they are prepared to pay haemophiliacs who have become infected. Most legal interest centres on the gap between when the viral transmission of AIDS was first established and when virucidal treatment of blood products began. Claims are also now being made by people who have developed HIV infection after blood transfusions. How they are settled may be a pointer to how countries will respond to future claims from people who contract hepatitis C or retroviral infections from blood transfusions, now that tests for these viruses are available (or very soon will be). Details of the British government's ex gratia payments to haemophiliacs have been given previously (2 December 1989, p 1358), as have preliminary details of a group action by haemophiliacs alleging negligence by the British government (16 September 1989, p 700). Here we provide an update on that case and a summary of what is happening elsewhere. (For details on France see 25 November 1989, p 1302.)-TONY DELAMOTHE
Australia decision by the Australian $A13 2m (£265m) assistance package more than 100 people infected with HIV from blood or blood products are continuing with litigation. Last November, after considerable lobbying, the federal government agreed to set up a trust fund that would help individual people ". . .infected as a consequence of medical procedures prior to the protection of the blood supply and blood products." The trust is to be administered by a board, which will include representatives of the affected groups and will make decisions based on need and hardship. The Minister for Community Services and Health, Dr Neal Blewett, made no admission of liability but stated that if any recipients of assistance gain damages in a court case they will have to repay the trust. It is unclear how many people may have been infected with HIV as a result of transfusions. New South Wales's blood banks have a "Lookback" programme that is trying to trace the 270 000 people who were given blood between 1980 and 1985. So far only 10000 have been tested, with 100 being
Despite
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VOLUME 300
13 JANUARY 1990
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Biodegradability isn't everything: in developing countnes posters made ofpaper may survive only weeks. Teaching Aids At Low Cost (TALC) hasfound that four-colour messages can beprinted on the bonded nylon usedfor the sacks that carry chemicals. It doesn't tear, resists neat household bleach, and is cheaper to print on than paper. Samples ofthis 90 x 60 cm poster and another smaller one produced by the International Planned Parenthood Federation are available from TALC, Box 49, StAlbans ALI 4AX, price £2 or $3.50
found to be antibody positive, including six cases of mother to child transmission. Solicitor Peter Cashman, whose firm represents most of the litigants in Australia, estimates that there may be as many as 1000 people with HIV infection as a result of receiving blood or blood products, perhaps 60% of whom have haemophilia. But for many reasons most are not taking action. Court actions in Western Australia and Victoria allege negligence on the part of the Red Cross, which runs the blood banks; the Commonwealth Serum Laboratories, which produce the factor VIII; and the hospitals. The most interesting action, though, is going to be in Sydney. This will be a difficult test of the Trade Practices Act and may well end up in the High Court. The plaintiffs are claiming that blood and blood products are goods supplied in trade or commerce and therefore fall under product liability. If the court agrees then negligence does not have to be proved. There is also a group action that is trying to use the British High Court decision in the Opren case to seek resolution of common issues but is not looking for cost sharing. -NORMAN SWAN
Italy By the end of 1987 almost one quarter of Italy's haemophiliacs were positive for HIV. Since the adoption in July 1985 of methods to inactivate HIV in blood products only three of seroconversion have occurred. The smaller proportion of infected haemophiliacs in Italy compared with countries
new cases
such as West Germany, which used the same American factor VIII concentrates, may be explained by the lower doses used in Italy. Certainly the highest rates of seropositivity in Italy have been among those haemophiliacs most seriously affected. The Italian government provides no compensation, though some political groups are now agitating for legislation to grant this. Given the speed at which parliament moves in Italy, any relief will be a long way off. To date no HIV infected haemophiliac has taken legal action against the ministry of health or any pharmaceutical company, hospital, or other authority. And solicitors are believed to be discouraging patients and their families from taking any such action. -
ANGIOLA BONO
Norway Twenty one-about one fifth-of Norway's severely affected haemophiliacs are HIV positive. Compensation of Kr 250 000 (£25 000) has been awarded to surviving haemophiliacs, and compensation for spouses has been set at Kr 100 000 (1O 000) by a committee working under the direction of the Norwegian parliament. To preserve confidentiality-nobody in small communities receives this much money from the Bank of Norway without questions being askedthe Institute for Haemophiliacs arranges payment.
Legal cases are pending for the few nonhaemophiliacs who have become HIV positive after receiving infected blood or blood 67
products. They were infected before 1985, when screening of blood donors began. Among the Scandinavian countries, Finland and Norway-which both used nationally produced blood products from relatively few donors-have lower prevale'nces of HIV infection than Denmark and Sweden.STEINAR WESTIN
Spain Of Spain's 2500 haemophiliacs, nearly 200 have contracted AIDS as a result of receiving contaminated blood products, half of whom have died. Last June the Spanish parliament rejected any compensation for those infected with HIV or their relatives. Although all the other political parties were in favour of compensation, the socialist party, which has the majority, argued that haemophiliacs should not be treated any differently from other AIDS victims. If they were then the government could be accused of discriminating against other ill people for contracting the infection "voluntarily." (Most of Spain's 2000 cases of AIDS have been in drug misusers.) The number of new cases of AIDS among haemophiliacs has decreased since the introduction of stringent controls over domestic and imported blood products in February 1987. -MAGDALENA RUIZ
Switzerland Seven Swiss haemophiliacs are known to have been infected with HIV from contaminated blood products, and another 15 people have developed AIDS after blood transfusions. No provision exists for compensation for haemophiliacs either by sickness insurance or from manufacturers of blood products, though claims have been made by the Swiss Haemophilia Society and the possibility of government compensation is being discussed. The legal position of those contracting AIDS after blood transfusion is more tricky as it is difficult to prove the cause of the infection; as with haemophiliacs, no provision currently exists for compensation for these patients. -PHILIP SELBY
United Kingdom The compensation claim against the government by haemophiliacs infected with HIV
from contaminated blood products could reach court this year if their High Court application on 22 January succeeds. Their lawyers will ask Mr Justice Ognall to fix the trial for November 1990. The government, however, is pressing for early 1991, arguing that the earlier date will leave insufficient time to prepare the complex case. The deadline for joining the group action expires on 2 February. About a half of the 1200 haemophiliacs infected by tainted factor VIII have filed claims so far. The judge is expected to extend the deadline on 22 January only for children under 16. Rules coming into force in April will allow children to qualify for legal aid in their own right regardless of their parents' means. The change will allow up to 200 children whose parents are too well off for legal aid to join in the claim, according to the Haemophilia Society. 68
Mr Justice Ognall has rejected proposals by both sides that he should hold a preliminary trial this month on two key issues in the case: whether the government can be sued on its policy over allocation of resources and whether the licensing authority for medicines owes a duty of care to individual people. The haemophiliacs' lawyers argue that the government was negligent in not becoming self sufficient in blood products sooner and in not heat treating earlier to kill the virus. Non-haemophiliacs infected by whole blood transfusions before HIV screening was introduced in 1985 are also launching legal actions. Lawyers know of at least 10 such cases. A 26 year old man who is suing the Scottish Blood Transfusion Service for £200 000 compensation failed last month in a bid to force the service to hand over the name of the donor who infected him. The man, who received the transfusions after receiving a bone marrow transplant, alleges that the donor knew that he was in a high risk group. Lawyers advised that he should sue the donor as well as the transfusion service. In the Court of Session in Edinburgh the judge, Lord Morison, questioned arguments by Mr Malcolm Rifkind, the Scottish secretary, that disclosure would put future donors off giving blood and endanger- future blood supplies. But an earlier ruling binding on the court meant that it could not assess the merits of Mr Rifkind's objection or investigate the basis for his assertion that disclosure might put the blood supply at risk. It had to accept the Scottish secretary's conclusion that there would be a risk to the national blood supply. That risk outweighed the man's right to seek redress against the donor in the courts. CLARE DYER
United States According to attorney Donald S Goldman, who is a past president and board member of the National Hemophilia Foundation, "there are no successful lawsuits in the United States based on allegations involving infection with HIV as a result of clotting factor, although some cases were settled out of court with some defendants." One company, for example, settled a case by agreeing to make a donation to a charitable
organisation. Although class certification suits have been brought against at least four clotting factor manufacturers (Business Week, 13 April 1987), none were certified as class actions. If any had been then between 6000 and 10000 haemo-
philiacs infected with HIV could have joined together in one lawsuit, raising the stakes high enough to have threatened the companies' economic survival (as happened with the Dalkon shield class action suit against A H Robins Co). To win a class action suit it would have been necessary to prove that the manufacturer was negligent in not heat treating its clotting factor when evidence became available that many haemophiliacs were becoming infected with HIV. Meanwhile, advanced phase II clinical trials are proceeding with genetically engineered clotting factor produced by Genentech (with Cutter Laboratories) and Genetics In-
Liberty but no successful lawsuits yet in the United States
stitute (with Baxter Travenol). The Food and Drug Administration is expected to approve one or both of them in about a year's time. REGINALD RHEIN JR
West Germany By 1985 about half of Germany's haemophiliacs had been infected with HIV. Action that might have reduced the death toll should have begun in the summer of 1983 when the council of ministers of the European Community in Strasbourg recommended that Europe should stop importing blood products from the United States and build up its own supplies. The Bundesgesundheitsamt (BGA) or federal health office, however, was reluctant to stop sales of American blood products in Germany, though safer factor VIII preparations were already available: two years earlier the German company Behringwerke of Marburg had introduced a heat treated factor VIII concentrate. Some of the BGA's difficulties resulted from the resistance of the German Red Cross to discard its supplies of blood products. The Red Cross also refused to screen blood donors for evidence of hepatitis B infection, which might have been a pointer to HIV infection. In addition, public health insurers remained unconvinced that contaminated blood products might transmit HIV and agreed to pay for the safer, more expensive preparations in only a few cases. In 1987 haemophiliacs' organisations and the pharmaceutical producers came to an extrajudicial settlement over compensation. The patients were promised help "quickly and without appeal to court." Other details were kept secret, but by the end of last year about 1000 of Germany's HIV infected haemophiliacs had each received between DM 80 000 and 500 000 (30 000-185 000).HELMUT L KARCHER
BMJ VOLUME 300
13 JANUARY 1990
Coma patients in The Netherlands Earlier this week Dutch doctors stopped artificially feeding a woman who has been in an irreversible coma smce a caesarean section 15 years ago (Daily Telegraph, 9 January). She became the centre of a legal wrangle when her husband resorted to court action early in 1987 after he was unsuccessful in preventing the staff at a nursing home from continuing to feed her artificially. In July 1987 the Court ofAlmelo ruled that the doctor should be allowed to decide to continue to feed the patient (Mrs S). She does not have a living will which asks that medical treatment be stopped in the case of irreversible coma. In 1988 the husband appealed to a higher court in Arnhem, but in October 1989 it endorsed the earlier judgment. Under the present penal code in The Netherlands voluntary euthanasia is a criminal offence, but it is often "allowed"-in the sense that the doctor responsible is not likely to be prosecuted-if it is performed at the explicit request of the patient and under strict conditions. Any doctorwho deliberately ends a patient's life in the absence of this express wish could face prosecution for murder. The only legal way to end the life of a comatose patient is to stop medical treatment when it has become medically pointless. Clearly the courts at Almelo and Arnhem regard this as a decision for the doctor; it must be based on medical considerations alone-not the quality of the patient's life; The Court of Appeal at Arnhem decided that in the case of Mrs S the decision to end artificial feeding was a medical one that must be left to the doctor. Although most doctors, health lawyers, and courts in The Netherlands would accept that it is medically pointless to continue feeding Mrs S, the nasogastric tube remained in place because the medical and nursing staff at the home were not prepared to oversee the process of dehydration and starvation that would eventually cause her death; nor did the Court of Appeal at Arnhem believe that this could be asked of the nursing home. The
This week's contributors: Angiola Bono is a science writer in Milan Tony Delamothe is an assistant editor of the
BMJ Clare Dyer is the BMJ's legal correspondent Daphne Gloag is a staff editor of the BMJ Helmut L Karcher is a science writer in Munich H J J Leenen is professor of social medicine and health law at the University of Amsterdam Reginald Rhein Jr is a medical journalist in Glen Echo, Maryland Magdalena Ruiz is a science writer in Madrid Philip Selby is a medical journalist in Geneva Norman Swan is a medical journalist and broadcaster in Sydney Steinar Westin is an associate professor in the department of community medicine, University of Trondheim
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husband decided not to appeal to the Supreme Court. As we went to press we could not determine why the nursing home was now prepared to remove the feeding tube. In the wake of public discussion about Mrs S the state prosecutor has announced that he will bring a test case in which a comatose patient died in September 1987 after being given a fatal injection by a neurologist in a hospital in Delft. If the neurologist is prosecuted the case is likely to go to the Court of Appeal and to the Supreme Court, a process that will take at least two years. H J J LEENEN
Out of mind, out of sight
"He's bored out of his mind and we are burnt out," said the mother of a young man severely disabled by a head injury (figure). Though intelligent and with much to offer, he had been turned down by day centres and other units because of psychotic behaviour problems, and he illustrated the need for specialised units for the victims of serious head injury. The occasion was a recent conference on brain injury held by Leicestershire Health Authority, which is planning to develop comprehensive services for management, rehabilitation, and long term helpservices, it was agreed, needed to support the whole family and to foster the potential for long term improvement, above all avoiding a negative approach. One speaker, whom doctors had predicted when he was injured 27 years ago would never be independent, had been to New Zealand on his own and was still improving. One way ahead was to have a "key worker" or coordinator for each patient, with a whole team of professionals (including the crucial clinical psychologist) to draw on from an early stage. In the long run effective services could represent financial savings, pointed out a neurosurgeon, citing the case of a young man who got a first class mathematics degree after his head injury-even his first year's
than the cost of his lengthy and expensive hospital treatment.
income tax was more
-
DAPHNE GLOAG
HIRE (Head Injury Re-Education-associated with Headway) promotes long term educational provision for head injured people of all ages. Details from the secretary, 1 Pembroke Drive, Nottingham NG3 SBG.
Ambulance dispute Hopes for a breakthrough in the ambulance dispute-now in its fifth month-were raised temporarily last weekend by newspaper reports that the government's "final offer" of 9% over 18 months may not have been so final and the ambulance unions may have been prepared to accept less than the lI 14% over 12 months that they were claiming. The NHS management rejected any further negotiations, however, until the unions provided more details of their concessions. The reports of progress came at the end of a difficult week for the government. It began with the fallout from the secretary of state's response to a letter from an ambulance worker's daughter in which she argued for parity of the ambulance service with other emergency services. "The vast majority of ambulance staff have had no extended paramedical training at all," Mr Clarke replied. "They are professional drivers, a worthwhile job-but not an exceptional one." That earned Mr Clarke an expression of deep concern from the chief ambulance officers, who later in the week were found by the Financial Times to be overwhelmingly in favour of a pay formula or pay review body. Speakers at the BMA council meeting on 3 January produced several personal examples of how "professional drivers" failed to do justice to the work of ambulance staff engaged in non-emergency duties. The council passed a resolution expressing its "grave concern at the prolongation of the present ambulance dispute, which is having such a deleterious effect on the care of patients." It called on the secretary of state "to recognise the valuable contribution of all ambulance workers to patient care and to settle the dispute as speedily as possible to restore the service to normal." The Casualty Surgeons Association "was in no doubt that patients are suffering indignity, discomfort and distress.... At the very worst, patients are losing their lives as a result of the dispute." Six Labour controlled councils in the west midlands decided to set up a council run ambulance service, and at a meeting on 4 January union leaders called for ambulance workers who had been suspended or had their pay docked to refuse management instructions and establish their own emer-
service from midnight on 10 January. The same meeting called for the public to give some sign of its support for the emergency services for 15 minutes from noon on 30 January. An earlier demonstration of popular support for the ambulance workers is expected at a mass rally in Trafalgar Square on 13 January. -TONY DELAMOTHE
gency
69
Week Underwater ping pong in Whitehall The
Asked for an impression of his first meeting, a newly elected member of the BMA council described it as "like playing ping pong under water." That erstwhile recruit is now a battle hardened veteran of many council debates, and he told me at the first council meeting of the 'nineties (p 126) that his nutshell diagnosis held good. To be fair to the BMA council - and I do try -his description could reasonably be applied to many activities in politics, and the worsening dispute in the ambulance service is a good example (p 69). On the face of it the contest appears to be between Kenneth Clarke, Secretary of State for Health, and Roger Poole, chief negotiator for the five unions that represent ambulance staff. But when appearing or being quoted (or misquoted) throughout the media Mr Clarke regularly points to Mr Duncan Nichol, chief executive of the NHS Management Executive, as the man in charge on the management side. (If you believe that you'll believe in the government's promise to give local management more power in the post1991 NHS.) And is Mr Poole really the union leader or simply an effective media communicator tied by the five competing union interests he represents? (What historical nonsense that it needs five unions to represent 22000 staff doing broadly the same work.) And has or has not Mr Clarke got more money to offer as suggested or implied at his (initially) unattributable briefing to Sunday newspaper reporters? And are the unions really prepared to modify their claim, in particular their demand for a pay formula like that of the fire service? And who is (are) the mysterious intermediary(ies) who supposedly keep the two sides in touch?
Patients at risk While this Whitehall underwater ping pong continues and Kenneth Clarke's reputation gurgles rapidly down the plughole patients are put increasingly at risk, other health service staff suffer additional strains, and overworked police and armed forces staff unfamiliar with civilian ambulance work try to plug the gaps in the emergency service. By the time you read this column parliament will have reassembled, an opposition initiated debate on the dispute will have taken place (11 January), and, who knows, Mr Clarke may have found sufficient money to satisfy a suitably modified union demand. But as an example of how not to conduct pay negotiations and how manipulation of the media can backfire this dispute could usefully enter the curriculum of management courses and union weekend schools. Doctors and nurses should offer thanks that their pay is settled by review bodieswhich, incidentally, should be reporting some time in the next few weeks. I have no inside information on the likely size of these awards, though I would be surprised if they were not closer to 10% than 6%. So unless the government settles the ambulance dispute 70
C) ,o ,z
*I" soon it could face even more embarrassment if the review bodies recommend substantially greater percentage increases than that presently being offered to ambulance staff. Admittedly if that happens the government, which is responsible for publishing review body reports, might find it expedient to delay any announcement and be tempted to modify the size of the award-as it has not hesitated to do on several recent occasions. The Cabinet is in a cleft stick. If it approves awards nearer 10% than 6% it will seriously disrupt health authority budgets based on 5% pay inflation. If, however, it interferes with the awards then its already troubled programme for reforming the NHS could be in even greater difficulty. Doctors and nurses disgruntled over pay can hardly be expected to implement unpopular and hastily imposed changes with any greater enthusiasm than they have displayed so far. In that event Kenneth Clarke could even find himself propelled towards the same backbench exit as his predecessor, John Moore. The BMA council spent much time on the NHS review and the ambulance dispute and rightly so as both subjects have profound consequences for the NHS. Indeed, last week saw doctors speaking out officially for the first time on the damaging effects of the dispute. For the council, however, an equally important message that it wanted to get across to the public and to doctors was that the BMA's constructive opposition to certain aspects of the National Health Service and Community Care Bill now going through parliament was as determined as ever. The fact that the association's activities were no longer attracting the publicity generated by its summer advertising campaign did not mean that they were any the less effective. Influencing parliament requires reasoned argument conducted behind the scenes:
trumpet calls from the battlements of BMA House are out of place. Nevertheless, council members left no doubt about their continuing anxieties over the bill and over the need to keep doctors informed and alert to the importance of sustaining local opposition to its unpalatable parts. Some of the proposals are desirable and workable-for example, medical audit, better information, greater efficiency, and a more effective response to what patients need. Others, such as self governing trusts and general practitioner budgets, are unproved and if introduced in haste and without trial could be irreparably damaging to the NHS. Doctors are in a strong position to influence the reforms; they should do so and not simply shrug their shoulders and leave it to the BMA and other professional bodies to argue the case in London. Constructive arguments over the reforms are vital in every health authority, hospital, and family practitioner committee. This is particularly important in the light of two developments raised by members of council. Firstly, the government is already spending substantial sums on preparing for the changes in advance of parliamentary approval, a point forcefully put by Dr Colin Smith, chairman of the Medical Academic Staff Committee. This possibly illegal expenditure is already being challenged by Professor Harry Keen and his supporters, with a judicial review set for the end of the month.
Centralisation of power Of greater significance long term, however, is the power taken directly and indirectly by the secretary of state to appoint members of health authorities and the absence from those authorities of any local voice either from the public or from the health professions. This centralisation of power sits uncomfortably with the government's stated aim to make the NHS more responsive to patients' needs and to local requirements. The pressure that has been exerted from the centre to propel health authorities along the road to reform, in particular the dubious tactics used to encourage recruits for trust status, augurs ill for the freedom of health authorities and trusts to act as they think best for their communities. Anyway, the opening clauses of the National Health Service and Community Care Bill deal with the composition of health authorities. The BMA has stimulated amendments to broaden their membership to include professional and community representation, and although the government's majority may prevail, at least the subject should get a full airing at the House of Commons committee stage, which resumed on 9 January. This may prompt the House of Lords to attempt appropriate amendments to make health authorities more accountable to their local communities. SCRUTATOR
BMJ
VOLUME
300
13 JANUARY 1990
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It seems likely that in every country where haemophiliacs received blood products between 1980 and 1985 some of them will have been infected with HIV, with the proportion varying according to the prevalence of HIV in the population from which the clotting factors came. Countries (and pharmaceutical companies) vary, too, in how much compensation they are prepared to pay haemophiliacs who have become infected. Most legal interest centres on the gap between when the viral transmission of AIDS was first established and when virucidal treatment of blood products began. Claims are also now being made by people who have developed HIV infection after blood transfusions. How they are settled may be a pointer to how countries will respond to future claims from people who contract hepatitis C or retroviral infections from blood transfusions, now that tests for these viruses are available (or very soon will be). Details of the British government's ex gratia payments to haemophiliacs have been given previously (2 December 1989, p 1358), as have preliminary details of a group action by haemophiliacs alleging negligence by the British government (16 September 1989, p 700). Here we provide an update on that case and a summary of what is happening elsewhere. (For details on France see 25 November 1989, p 1302.)-TONY DELAMOTHE
Australia decision by the Australian $A13 2m (£265m) assistance package more than 100 people infected with HIV from blood or blood products are continuing with litigation. Last November, after considerable lobbying, the federal government agreed to set up a trust fund that would help individual people ". . .infected as a consequence of medical procedures prior to the protection of the blood supply and blood products." The trust is to be administered by a board, which will include representatives of the affected groups and will make decisions based on need and hardship. The Minister for Community Services and Health, Dr Neal Blewett, made no admission of liability but stated that if any recipients of assistance gain damages in a court case they will have to repay the trust. It is unclear how many people may have been infected with HIV as a result of transfusions. New South Wales's blood banks have a "Lookback" programme that is trying to trace the 270 000 people who were given blood between 1980 and 1985. So far only 10000 have been tested, with 100 being
Despite
a recent
government to set up a
BMJ
VOLUME 300
13 JANUARY 1990
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Biodegradability isn't everything: in developing countnes posters made ofpaper may survive only weeks. Teaching Aids At Low Cost (TALC) hasfound that four-colour messages can beprinted on the bonded nylon usedfor the sacks that carry chemicals. It doesn't tear, resists neat household bleach, and is cheaper to print on than paper. Samples ofthis 90 x 60 cm poster and another smaller one produced by the International Planned Parenthood Federation are available from TALC, Box 49, StAlbans ALI 4AX, price £2 or $3.50
found to be antibody positive, including six cases of mother to child transmission. Solicitor Peter Cashman, whose firm represents most of the litigants in Australia, estimates that there may be as many as 1000 people with HIV infection as a result of receiving blood or blood products, perhaps 60% of whom have haemophilia. But for many reasons most are not taking action. Court actions in Western Australia and Victoria allege negligence on the part of the Red Cross, which runs the blood banks; the Commonwealth Serum Laboratories, which produce the factor VIII; and the hospitals. The most interesting action, though, is going to be in Sydney. This will be a difficult test of the Trade Practices Act and may well end up in the High Court. The plaintiffs are claiming that blood and blood products are goods supplied in trade or commerce and therefore fall under product liability. If the court agrees then negligence does not have to be proved. There is also a group action that is trying to use the British High Court decision in the Opren case to seek resolution of common issues but is not looking for cost sharing. -NORMAN SWAN
Italy By the end of 1987 almost one quarter of Italy's haemophiliacs were positive for HIV. Since the adoption in July 1985 of methods to inactivate HIV in blood products only three of seroconversion have occurred. The smaller proportion of infected haemophiliacs in Italy compared with countries
new cases
such as West Germany, which used the same American factor VIII concentrates, may be explained by the lower doses used in Italy. Certainly the highest rates of seropositivity in Italy have been among those haemophiliacs most seriously affected. The Italian government provides no compensation, though some political groups are now agitating for legislation to grant this. Given the speed at which parliament moves in Italy, any relief will be a long way off. To date no HIV infected haemophiliac has taken legal action against the ministry of health or any pharmaceutical company, hospital, or other authority. And solicitors are believed to be discouraging patients and their families from taking any such action. -
ANGIOLA BONO
Norway Twenty one-about one fifth-of Norway's severely affected haemophiliacs are HIV positive. Compensation of Kr 250 000 (£25 000) has been awarded to surviving haemophiliacs, and compensation for spouses has been set at Kr 100 000 (1O 000) by a committee working under the direction of the Norwegian parliament. To preserve confidentiality-nobody in small communities receives this much money from the Bank of Norway without questions being askedthe Institute for Haemophiliacs arranges payment.
Legal cases are pending for the few nonhaemophiliacs who have become HIV positive after receiving infected blood or blood 67
products. They were infected before 1985, when screening of blood donors began. Among the Scandinavian countries, Finland and Norway-which both used nationally produced blood products from relatively few donors-have lower prevale'nces of HIV infection than Denmark and Sweden.STEINAR WESTIN
Spain Of Spain's 2500 haemophiliacs, nearly 200 have contracted AIDS as a result of receiving contaminated blood products, half of whom have died. Last June the Spanish parliament rejected any compensation for those infected with HIV or their relatives. Although all the other political parties were in favour of compensation, the socialist party, which has the majority, argued that haemophiliacs should not be treated any differently from other AIDS victims. If they were then the government could be accused of discriminating against other ill people for contracting the infection "voluntarily." (Most of Spain's 2000 cases of AIDS have been in drug misusers.) The number of new cases of AIDS among haemophiliacs has decreased since the introduction of stringent controls over domestic and imported blood products in February 1987. -MAGDALENA RUIZ
Switzerland Seven Swiss haemophiliacs are known to have been infected with HIV from contaminated blood products, and another 15 people have developed AIDS after blood transfusions. No provision exists for compensation for haemophiliacs either by sickness insurance or from manufacturers of blood products, though claims have been made by the Swiss Haemophilia Society and the possibility of government compensation is being discussed. The legal position of those contracting AIDS after blood transfusion is more tricky as it is difficult to prove the cause of the infection; as with haemophiliacs, no provision currently exists for compensation for these patients. -PHILIP SELBY
United Kingdom The compensation claim against the government by haemophiliacs infected with HIV
from contaminated blood products could reach court this year if their High Court application on 22 January succeeds. Their lawyers will ask Mr Justice Ognall to fix the trial for November 1990. The government, however, is pressing for early 1991, arguing that the earlier date will leave insufficient time to prepare the complex case. The deadline for joining the group action expires on 2 February. About a half of the 1200 haemophiliacs infected by tainted factor VIII have filed claims so far. The judge is expected to extend the deadline on 22 January only for children under 16. Rules coming into force in April will allow children to qualify for legal aid in their own right regardless of their parents' means. The change will allow up to 200 children whose parents are too well off for legal aid to join in the claim, according to the Haemophilia Society. 68
Mr Justice Ognall has rejected proposals by both sides that he should hold a preliminary trial this month on two key issues in the case: whether the government can be sued on its policy over allocation of resources and whether the licensing authority for medicines owes a duty of care to individual people. The haemophiliacs' lawyers argue that the government was negligent in not becoming self sufficient in blood products sooner and in not heat treating earlier to kill the virus. Non-haemophiliacs infected by whole blood transfusions before HIV screening was introduced in 1985 are also launching legal actions. Lawyers know of at least 10 such cases. A 26 year old man who is suing the Scottish Blood Transfusion Service for £200 000 compensation failed last month in a bid to force the service to hand over the name of the donor who infected him. The man, who received the transfusions after receiving a bone marrow transplant, alleges that the donor knew that he was in a high risk group. Lawyers advised that he should sue the donor as well as the transfusion service. In the Court of Session in Edinburgh the judge, Lord Morison, questioned arguments by Mr Malcolm Rifkind, the Scottish secretary, that disclosure would put future donors off giving blood and endanger- future blood supplies. But an earlier ruling binding on the court meant that it could not assess the merits of Mr Rifkind's objection or investigate the basis for his assertion that disclosure might put the blood supply at risk. It had to accept the Scottish secretary's conclusion that there would be a risk to the national blood supply. That risk outweighed the man's right to seek redress against the donor in the courts. CLARE DYER
United States According to attorney Donald S Goldman, who is a past president and board member of the National Hemophilia Foundation, "there are no successful lawsuits in the United States based on allegations involving infection with HIV as a result of clotting factor, although some cases were settled out of court with some defendants." One company, for example, settled a case by agreeing to make a donation to a charitable
organisation. Although class certification suits have been brought against at least four clotting factor manufacturers (Business Week, 13 April 1987), none were certified as class actions. If any had been then between 6000 and 10000 haemo-
philiacs infected with HIV could have joined together in one lawsuit, raising the stakes high enough to have threatened the companies' economic survival (as happened with the Dalkon shield class action suit against A H Robins Co). To win a class action suit it would have been necessary to prove that the manufacturer was negligent in not heat treating its clotting factor when evidence became available that many haemophiliacs were becoming infected with HIV. Meanwhile, advanced phase II clinical trials are proceeding with genetically engineered clotting factor produced by Genentech (with Cutter Laboratories) and Genetics In-
Liberty but no successful lawsuits yet in the United States
stitute (with Baxter Travenol). The Food and Drug Administration is expected to approve one or both of them in about a year's time. REGINALD RHEIN JR
West Germany By 1985 about half of Germany's haemophiliacs had been infected with HIV. Action that might have reduced the death toll should have begun in the summer of 1983 when the council of ministers of the European Community in Strasbourg recommended that Europe should stop importing blood products from the United States and build up its own supplies. The Bundesgesundheitsamt (BGA) or federal health office, however, was reluctant to stop sales of American blood products in Germany, though safer factor VIII preparations were already available: two years earlier the German company Behringwerke of Marburg had introduced a heat treated factor VIII concentrate. Some of the BGA's difficulties resulted from the resistance of the German Red Cross to discard its supplies of blood products. The Red Cross also refused to screen blood donors for evidence of hepatitis B infection, which might have been a pointer to HIV infection. In addition, public health insurers remained unconvinced that contaminated blood products might transmit HIV and agreed to pay for the safer, more expensive preparations in only a few cases. In 1987 haemophiliacs' organisations and the pharmaceutical producers came to an extrajudicial settlement over compensation. The patients were promised help "quickly and without appeal to court." Other details were kept secret, but by the end of last year about 1000 of Germany's HIV infected haemophiliacs had each received between DM 80 000 and 500 000 (30 000-185 000).HELMUT L KARCHER
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Coma patients in The Netherlands Earlier this week Dutch doctors stopped artificially feeding a woman who has been in an irreversible coma smce a caesarean section 15 years ago (Daily Telegraph, 9 January). She became the centre of a legal wrangle when her husband resorted to court action early in 1987 after he was unsuccessful in preventing the staff at a nursing home from continuing to feed her artificially. In July 1987 the Court ofAlmelo ruled that the doctor should be allowed to decide to continue to feed the patient (Mrs S). She does not have a living will which asks that medical treatment be stopped in the case of irreversible coma. In 1988 the husband appealed to a higher court in Arnhem, but in October 1989 it endorsed the earlier judgment. Under the present penal code in The Netherlands voluntary euthanasia is a criminal offence, but it is often "allowed"-in the sense that the doctor responsible is not likely to be prosecuted-if it is performed at the explicit request of the patient and under strict conditions. Any doctorwho deliberately ends a patient's life in the absence of this express wish could face prosecution for murder. The only legal way to end the life of a comatose patient is to stop medical treatment when it has become medically pointless. Clearly the courts at Almelo and Arnhem regard this as a decision for the doctor; it must be based on medical considerations alone-not the quality of the patient's life; The Court of Appeal at Arnhem decided that in the case of Mrs S the decision to end artificial feeding was a medical one that must be left to the doctor. Although most doctors, health lawyers, and courts in The Netherlands would accept that it is medically pointless to continue feeding Mrs S, the nasogastric tube remained in place because the medical and nursing staff at the home were not prepared to oversee the process of dehydration and starvation that would eventually cause her death; nor did the Court of Appeal at Arnhem believe that this could be asked of the nursing home. The
This week's contributors: Angiola Bono is a science writer in Milan Tony Delamothe is an assistant editor of the
BMJ Clare Dyer is the BMJ's legal correspondent Daphne Gloag is a staff editor of the BMJ Helmut L Karcher is a science writer in Munich H J J Leenen is professor of social medicine and health law at the University of Amsterdam Reginald Rhein Jr is a medical journalist in Glen Echo, Maryland Magdalena Ruiz is a science writer in Madrid Philip Selby is a medical journalist in Geneva Norman Swan is a medical journalist and broadcaster in Sydney Steinar Westin is an associate professor in the department of community medicine, University of Trondheim
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husband decided not to appeal to the Supreme Court. As we went to press we could not determine why the nursing home was now prepared to remove the feeding tube. In the wake of public discussion about Mrs S the state prosecutor has announced that he will bring a test case in which a comatose patient died in September 1987 after being given a fatal injection by a neurologist in a hospital in Delft. If the neurologist is prosecuted the case is likely to go to the Court of Appeal and to the Supreme Court, a process that will take at least two years. H J J LEENEN
Out of mind, out of sight
"He's bored out of his mind and we are burnt out," said the mother of a young man severely disabled by a head injury (figure). Though intelligent and with much to offer, he had been turned down by day centres and other units because of psychotic behaviour problems, and he illustrated the need for specialised units for the victims of serious head injury. The occasion was a recent conference on brain injury held by Leicestershire Health Authority, which is planning to develop comprehensive services for management, rehabilitation, and long term helpservices, it was agreed, needed to support the whole family and to foster the potential for long term improvement, above all avoiding a negative approach. One speaker, whom doctors had predicted when he was injured 27 years ago would never be independent, had been to New Zealand on his own and was still improving. One way ahead was to have a "key worker" or coordinator for each patient, with a whole team of professionals (including the crucial clinical psychologist) to draw on from an early stage. In the long run effective services could represent financial savings, pointed out a neurosurgeon, citing the case of a young man who got a first class mathematics degree after his head injury-even his first year's
than the cost of his lengthy and expensive hospital treatment.
income tax was more
-
DAPHNE GLOAG
HIRE (Head Injury Re-Education-associated with Headway) promotes long term educational provision for head injured people of all ages. Details from the secretary, 1 Pembroke Drive, Nottingham NG3 SBG.
Ambulance dispute Hopes for a breakthrough in the ambulance dispute-now in its fifth month-were raised temporarily last weekend by newspaper reports that the government's "final offer" of 9% over 18 months may not have been so final and the ambulance unions may have been prepared to accept less than the lI 14% over 12 months that they were claiming. The NHS management rejected any further negotiations, however, until the unions provided more details of their concessions. The reports of progress came at the end of a difficult week for the government. It began with the fallout from the secretary of state's response to a letter from an ambulance worker's daughter in which she argued for parity of the ambulance service with other emergency services. "The vast majority of ambulance staff have had no extended paramedical training at all," Mr Clarke replied. "They are professional drivers, a worthwhile job-but not an exceptional one." That earned Mr Clarke an expression of deep concern from the chief ambulance officers, who later in the week were found by the Financial Times to be overwhelmingly in favour of a pay formula or pay review body. Speakers at the BMA council meeting on 3 January produced several personal examples of how "professional drivers" failed to do justice to the work of ambulance staff engaged in non-emergency duties. The council passed a resolution expressing its "grave concern at the prolongation of the present ambulance dispute, which is having such a deleterious effect on the care of patients." It called on the secretary of state "to recognise the valuable contribution of all ambulance workers to patient care and to settle the dispute as speedily as possible to restore the service to normal." The Casualty Surgeons Association "was in no doubt that patients are suffering indignity, discomfort and distress.... At the very worst, patients are losing their lives as a result of the dispute." Six Labour controlled councils in the west midlands decided to set up a council run ambulance service, and at a meeting on 4 January union leaders called for ambulance workers who had been suspended or had their pay docked to refuse management instructions and establish their own emer-
service from midnight on 10 January. The same meeting called for the public to give some sign of its support for the emergency services for 15 minutes from noon on 30 January. An earlier demonstration of popular support for the ambulance workers is expected at a mass rally in Trafalgar Square on 13 January. -TONY DELAMOTHE
gency
69
Week Underwater ping pong in Whitehall The
Asked for an impression of his first meeting, a newly elected member of the BMA council described it as "like playing ping pong under water." That erstwhile recruit is now a battle hardened veteran of many council debates, and he told me at the first council meeting of the 'nineties (p 126) that his nutshell diagnosis held good. To be fair to the BMA council - and I do try -his description could reasonably be applied to many activities in politics, and the worsening dispute in the ambulance service is a good example (p 69). On the face of it the contest appears to be between Kenneth Clarke, Secretary of State for Health, and Roger Poole, chief negotiator for the five unions that represent ambulance staff. But when appearing or being quoted (or misquoted) throughout the media Mr Clarke regularly points to Mr Duncan Nichol, chief executive of the NHS Management Executive, as the man in charge on the management side. (If you believe that you'll believe in the government's promise to give local management more power in the post1991 NHS.) And is Mr Poole really the union leader or simply an effective media communicator tied by the five competing union interests he represents? (What historical nonsense that it needs five unions to represent 22000 staff doing broadly the same work.) And has or has not Mr Clarke got more money to offer as suggested or implied at his (initially) unattributable briefing to Sunday newspaper reporters? And are the unions really prepared to modify their claim, in particular their demand for a pay formula like that of the fire service? And who is (are) the mysterious intermediary(ies) who supposedly keep the two sides in touch?
Patients at risk While this Whitehall underwater ping pong continues and Kenneth Clarke's reputation gurgles rapidly down the plughole patients are put increasingly at risk, other health service staff suffer additional strains, and overworked police and armed forces staff unfamiliar with civilian ambulance work try to plug the gaps in the emergency service. By the time you read this column parliament will have reassembled, an opposition initiated debate on the dispute will have taken place (11 January), and, who knows, Mr Clarke may have found sufficient money to satisfy a suitably modified union demand. But as an example of how not to conduct pay negotiations and how manipulation of the media can backfire this dispute could usefully enter the curriculum of management courses and union weekend schools. Doctors and nurses should offer thanks that their pay is settled by review bodieswhich, incidentally, should be reporting some time in the next few weeks. I have no inside information on the likely size of these awards, though I would be surprised if they were not closer to 10% than 6%. So unless the government settles the ambulance dispute 70
C) ,o ,z
*I" soon it could face even more embarrassment if the review bodies recommend substantially greater percentage increases than that presently being offered to ambulance staff. Admittedly if that happens the government, which is responsible for publishing review body reports, might find it expedient to delay any announcement and be tempted to modify the size of the award-as it has not hesitated to do on several recent occasions. The Cabinet is in a cleft stick. If it approves awards nearer 10% than 6% it will seriously disrupt health authority budgets based on 5% pay inflation. If, however, it interferes with the awards then its already troubled programme for reforming the NHS could be in even greater difficulty. Doctors and nurses disgruntled over pay can hardly be expected to implement unpopular and hastily imposed changes with any greater enthusiasm than they have displayed so far. In that event Kenneth Clarke could even find himself propelled towards the same backbench exit as his predecessor, John Moore. The BMA council spent much time on the NHS review and the ambulance dispute and rightly so as both subjects have profound consequences for the NHS. Indeed, last week saw doctors speaking out officially for the first time on the damaging effects of the dispute. For the council, however, an equally important message that it wanted to get across to the public and to doctors was that the BMA's constructive opposition to certain aspects of the National Health Service and Community Care Bill now going through parliament was as determined as ever. The fact that the association's activities were no longer attracting the publicity generated by its summer advertising campaign did not mean that they were any the less effective. Influencing parliament requires reasoned argument conducted behind the scenes:
trumpet calls from the battlements of BMA House are out of place. Nevertheless, council members left no doubt about their continuing anxieties over the bill and over the need to keep doctors informed and alert to the importance of sustaining local opposition to its unpalatable parts. Some of the proposals are desirable and workable-for example, medical audit, better information, greater efficiency, and a more effective response to what patients need. Others, such as self governing trusts and general practitioner budgets, are unproved and if introduced in haste and without trial could be irreparably damaging to the NHS. Doctors are in a strong position to influence the reforms; they should do so and not simply shrug their shoulders and leave it to the BMA and other professional bodies to argue the case in London. Constructive arguments over the reforms are vital in every health authority, hospital, and family practitioner committee. This is particularly important in the light of two developments raised by members of council. Firstly, the government is already spending substantial sums on preparing for the changes in advance of parliamentary approval, a point forcefully put by Dr Colin Smith, chairman of the Medical Academic Staff Committee. This possibly illegal expenditure is already being challenged by Professor Harry Keen and his supporters, with a judicial review set for the end of the month.
Centralisation of power Of greater significance long term, however, is the power taken directly and indirectly by the secretary of state to appoint members of health authorities and the absence from those authorities of any local voice either from the public or from the health professions. This centralisation of power sits uncomfortably with the government's stated aim to make the NHS more responsive to patients' needs and to local requirements. The pressure that has been exerted from the centre to propel health authorities along the road to reform, in particular the dubious tactics used to encourage recruits for trust status, augurs ill for the freedom of health authorities and trusts to act as they think best for their communities. Anyway, the opening clauses of the National Health Service and Community Care Bill deal with the composition of health authorities. The BMA has stimulated amendments to broaden their membership to include professional and community representation, and although the government's majority may prevail, at least the subject should get a full airing at the House of Commons committee stage, which resumed on 9 January. This may prompt the House of Lords to attempt appropriate amendments to make health authorities more accountable to their local communities. SCRUTATOR
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