Germany: Court order responsible for fatal events?

107

Gerson and Kelly dietary regimens, macrobiological diets, and antineoplastons, which are peptides said to inhibit cancer cell growth. Subsequently, both the National Cancer Institute and the National Institute of Allergy and Infectious Diseases started programmes that encourage UMP therapists to ask for assistance from the institutes to set up scientific studies evaluating safety and efficacy. But last autumn the Senate Appropriations Committee declared that it was not "satisfied that the conventional medical community as symbolized by NIH has fully explored the potential that exists in unconventional medical practices". NIH has in the past been unhappy whenever Congress steps into the field of scientific inquiry, and this time is no exception. Many researchers are upset to see scarce research funds used to investigate what they see as having marginal possibilities. Nevertheless, Bernadine Healy, NIH director, said that NIH will use the$2 million appropriation to offer technical assistance and financial resources for scientifically rigorous evaluation of claims made on behalf of unproven therapies. She said scientists might be interested in exploring the mechanisms by which the therapies work. Stephen Groft, the director of the new office, says that the intent is not simply to discredit such therapies but to assess their therapeutic effect objectively and make them known to the public. The project is part of NCI’s Cancer Therapy Evaluation Program. In mid-June, at the first meeting of a 20-member advisory panel, NCI reported promising results on two UMPs: antineoplastons, which produced antitumour responses in primary brain cancer, and hydrazine sulphate, which improved appetite and weight gain in certain cancers. At future meetings, Groft said the panel will discuss issues such as cost-effectiveness and the effect UMPs may have on quality of life. Harry Nelson

Germany: Acceptable alternatives About 7 out of 10 general practitioners in Germany practise alternative medicine, and every year insurance companies spend millions of marks satisfying their clients’ wishes to be treated by "natural" methods. Practically none of these treatments has been scientifically assessed, but things are set to change. The Federal Science Ministry intends to provide research grants for complementary medicine, on the basis of a report (Unconventional Medical Directions) that it commissioned. In 1984 the Science Ministry set up a research

programme on alternative medicine for cancer, in response to public demand. Before extending the programme to other specialties, it commissioned a report from the University Witter/Herdecke, which has a strong interest in alternative medicine. A group led by Dr Peter Matthiessen has spent two years investigating 130 unconventional treatments; they interviewed practitioners, received published work, and held workshops. In the past few years there have been some attempts to integrate alternative with conventional medicine. For example, the medical faculties of Berlin and Ulm have chairs for Naturheilkunde, and the potential and the limits of complementary medicine form part of the medical school curriculum. Nevertheless the Herdecke report recommends even more integration. The proposals include the establishment of research groups and a biomedical centre,

and of clinical trials comparing conventional with alternative methods of treatment. The report also recommends the

development

of

adequate

means

of

treatment not amenable to assessment by

testing alternative standard methods.

says that the main principle of unconventional medicine-the stimulation of the natural healing forces of the body-deserves investigation. It lists five unconventional means of therapy as having evidence of efficacy and that are in common practice-homoeopathy, and anthroposophy, physiotherapy, balneology, acupuncture. The Science Ministry plans have not met with universal approval. In a letter to Frankfurter Allgemeine Zeitung, Prof Walter Rummel, a pharmacologist from Hamburg University, points out that mistletoe therapy, for instance, an essential part of anthroposophical medicine, is not recommended by the Swiss and American Cancer Societies because of its inefficacy. Rummel deplores spending money on "ideological medicine" rather than on conventional research into common disorders, especially since grants are becoming hard to come by.

Furthermore, the report

Annette Tuffs

Germany: Court order responsible for fatal events? In

May, 1990, Arteparon (Luitpold Werke, Munich) from bovine lung and trachea containing sulphated glycosaminoglycans and promoted as a chondroprotective agent in osteoarthritis-was put back on the market by court order, which overruled the decision of the drug regulatory agency (BGA) that the drug was ineffective and unsafe. Since then, two deaths from Arteparon have been reported. In December, 1991, a 58-year-old woman developed generalised hypersensitivity vasculitis with cutaneous, intestinal, and renal manifestations and Guillain-Barre syndrome within a week of a single injection of Arteparon into the knee. Immunosuppressive treatment was started, and the patient died from septicaemia. In May, 1992, a 71-year-old woman received two intra-articular injections of the drug into the

—an extract

went into severe shock 45 min after the second and died despite efforts to resuscitate her. injection was Arteparon put back on the market by court order against the advice of the regulatory agency. Who is responsible for the damage caused to patients? The Berlin courts accept evidence of drug effectiveness that is based not on clinical studies or scientific data, but on statements of experts, who are nominated by the drug producers and receive a fee. Clinical evidence of adverse drug effects is rejected if causality is not proved beyond scientific doubt 2 In a recent case the Berlin court flatly denied a causal relation between the use of L-tryptophan-containing drugs and the development of eosinophilic myalgia syndrome, since existing evidence does not prove a causal link between the development of the disease and every L-tryptophan-

knee. She

containing product.3 The next such case could well be Arumalon (Robapharm, Basle), an extract of bovine cartilage and bone marrow, also promoted as a chondroprotective agent. It was deemed ineffective by the BGA and causes shock, pulmonary fibrosis, nephrotic syndrome, myositis, and Guillain-Barre syndrome.4,5 The BGA had temporarily suspended the Arumalon licencebut again this decision is to be challenged in court. Court rulings not only hamper the work

108

of the

BGA, but also undermine the drug law by allowing uncontrolled personal experience as evidence of drug effectiveness and requiring proof of causality beyond doubt for adverse drug reactions. If mutual recognition of national drug regulatory decisions becomes the norm, the activities of the Berlin courts could have an impact on European drug regulations since court rulings override BGA decisions. Peter S. Schönhöfer Ulrich M. Moebius 1. Schönhöfer PS.

Germany: effective drug regulation hampered by courts.

Lancet 1991; 337: 904. 2.

Oberverwaltungsgericht Berlin,

Az. 55 124.89,

judgement

of

May 6,

1990.

Verwaltungsgericht Berlin, Az. 14 A 452.91, judgement of Mar 11, 1992. Bundesgesundheitsamt: Immunpathogene Wirkung durch Arumalon? Pharm Ztg 1992; 137: 1278. 5. Berg PA, Dürk H, Saal J, Hopf G. Bovine cartilage and bone marrow

register would be accessible to France-Transplant members around the clock. Minister of Health Bernard Kouchner has since agreed to set up a register listing not only those wanting opt-out, but also those stating their desire to be organ donors. All polls indicate that 70 to 75% of French citizens agree to donate their organs but doctors who approach families of potential donors for consent say that 50% of the to

families refuse to give permission for organ retrieval, in some cases against the wishes of the brain-dead patient. The existence of such a donor register should help gain the organs that would otherwise be lost because of family

objections. Jean-Michael Bader

3. 4.

extract. Lancet 1989; i: 1275. 6. Bundesgesundheitsamt: Ruhen der

Zulassung: Arumalon. Pharm Ztg

1991; 137: 1802.

France: Transnational

transplants

Since 1976 French law has decreed a brain-dead adult citizen a consenting organ donor unless he had previously opted out of being one. It is therefore not surprising that France does more transplantations per million inhabitants than any other European country (though several European countries have now also adopted the rule of presumed consent). Another factor contributing to the high transplantation rates is the existence of France-Transplant, a private national organ-sharing agency set up in 1969 by transplantation specialists. One side-effect is the growing number of non-residents coming to France to receive organs. Last year 903 of the 3538 patients on the national kidney waiting list were non-residents, as were 118 of the 326 on the liver list. 18% of transplant patients are non-residents-10% of the hearts, 14% of the kidneys, and 35 % of livers donated have gone to non-residents. To explore this trend, the Ministry of Health commissioned a national survey by its general inspectorate for social affairs (IGAS). The inspectors visited 27 hospitals, and talked to 90 transplantation teams that were responsible for 80% of all grafts. The IGAS survey found 1066 non-residents on waiting lists, along with 3172 residents: 921 (86%) of the nonresidents were Italians. 29% of all liver transplantations by the 22 medical teams visited by the IGAS inspectors were done on Italian patients; the proportion was 50% for one team, and over 86% for another. The IGAS fears that the demand for organs by nonresidents might mean that French residents are being denied transplants. Furthermore, non-residents do not pay the full costs of services received. One centre has calculated that a liver transplantation costs Fr 487 777 (including the cost of a year’s follow-up), but the Ministry of Health special tariff (for very costly procedures) is only Fr 372 492. IGAS has recommended that France-Transplant should become state-owned, that non-residents should be charged the full cost of the service received, and that the Ministry of Health should limit the number of foreign patients eligible for transplantation. France-Transplant president, Prof Christian Cabrol, has confirmed that the organisation would follow government guidelines on transplantation for nonresidents. Officials of France-Transplant had suggested in Le Monde on June 6 a national register of residents opting out of being an organ donor, as exists in Belgium. This

Medicine and the Law Refusal of treatment by 16-year-old In London, the Court of Appeal, in an interim ruling on July 2, 1992, ordered that a 16-year-old girl with anorexia nervosa should be treated against her own wishes. Some may argue that this decision strikes a blow against "children’s rights". There is, however, an equally persuasive argument that the most important right of such a child is not the adult right of autonomous choice, but the right to be protected until such time as she is mentally and emotionally capable of making adult decisions. The subject of the court’s ruling was a girl referred to as "J". J had lost her parents and, more recently, her grandfather. She was in local authority care and had for some time shown features of anorexia nervosa. At 1 -7 m tall, she weighed less than 40 kg.J was already a patient in a psychiatric facility, but doctors wished to transfer her to a special unit for eating disorders. J refused to go and stopped eating altogether. The case was initiated by the local authority in the High Court, where Mr Justice Thorpe ruled that J was to be treated as the doctors and the local authority deemed fit. In its preliminary ruling, the Court of Appeal upheld this decision, pending a full judgment on the legal arguments. On the facts of the case, the justification for imposing treatment may have been quite straightforward: it may be that J was simply not thought to be mentally competent to make important decisions about herself. It can certainly be argued that the effects of anorexia nervosa include such a distortion of self-perception as to render even a generally intelligent and sensible person incapable of rational choice in this area. If that is the basis of the court’s decision, then it would not have mattered that J was 16. Had she been 26 or 56, the decision might have been the same. If, as many would assert, anorexia nervosa falls within the statutory classification of mental illness, then it should have been

possible to resolve the matter by the compulsory detention of J under a section of the Mental Health Act 1983. However, there seems to be a curious reluctance to "section" adolescents. Although there is a stigma attached to being sectioned and it is generally thought desirable for patients to agree to admission, the voluntary/involuntary distinction becomes meaningless if adolescents avoid being sectioned only to be detained against their will by court order. The advantage of proceeding under the Mental Health Act is that there are at least limited procedural safeguards and appeal mechanisms. There is, though, a wider issue in this case, apart from the factual question of whether J was capable of exercising