- Email: [email protected]
Research pulls
735
the diagnosis of testicular tumour and metastasis was made. Treatment was unsuccessful and he died 7 years later. The judge said that for the case to succeed it would have to be established that tumour was present during the critical period in 1978. Some of the symptoms were consistent with a tumour, but there was nothing so evident as to persuade him that it was clearly demonstrable, at least during the early months. Applying a 1955 decision approved by the House of Lords in 1984, the judge said that it was not enough to say in defence simply that the matter was one of clinical judgment, but it was equally not enough for a pursuer to show that there was an error in clinical judgment. There was no doubt the doctors should have been aware of the possibility of tumour, and awareness of that possibility is reflected in the medical records. The judge decided that no valid criticism could be made of the registrar or consultant in not deciding on surgery when the patient was first an inpatient or when he attended as an outpatient between February and April, 1978. There was an infective condition in January, 1978, and it was not impossible that the patient had gonorrhoea. Even had negligence been proved, the claim would have been time-barred, the judge said. It was not until November, 1982, that the patient consulted solicitors with a view to a claim for negligence and it was not until July, 1985, that a summons was served.
charities, the Committee on Safety of Medicines (which last month approved the use of tamoxifen as a prophylactic agent), the US Food and Drug Administration (which last month gave approval for a similar trial, which will be formally announced next month), and the Government ministers who have given approval for the trial. Originally the plan was to recruit women in the UK from fifteen centres (1000 women each); six of these are MRC funded. The numbers will probably be made up by an Australian trial that will follow the UK protocol and that has been approved, and by recruitment in a couple of European countries that have expressed interest in the trial. Although there will now be no MRC involvement in the trial, the toxicology unit studies will continue. Dr Dai Rees, secretary to the MRC states that"... the MRC has no wish to spread alarm amongst women taking tamoxifen for proven cases of breast cancer.... The trial in question seeks to use the drug in well women. We have taken the view that until more evidence is obtained to inform better risk/benefit calculations the best course is to proceed with caution". cancer
Nayfield SG, Karp JE, Ford LG, Dorr FA, Kramer BS. Potential role of tamoxifen in prevention of breast cancer. J Natl Cancer Inst 1991, 83: 1450-59. 2. Han X, Liehr JG. Induction of covalent DNA adducts m rodents by tamoxifen. Cancer Res 1992; 52: 1360-63. 3. Fornander T, Rutqvist LE, Cedermark B, et al. Adjuvant tamoxifen in early breast cancer: occurrence of new primary tumours. Lancet 1989; i: 117-20. 4. Altaras MM, Avirath R, Beyth Y. Tamoxifen-associated endometrial carcinoma in postmenopausal breast cancer patients. Gynecol Oncol 1991; 41: 270. 5. Spicer DV, Pike MC, Henderson BE. Ovarian cancer and long-term tamoxifen in premenopausal women. Lancet 1991; 337: 1414. 6. Bentley CR, Davies G, Aclimondos WA. Tamoxifen retinopathy, a rare but serious complication, Br Med J 1992; 304: 495-96. 1.
Phillips v Grampian Health Board. Scottish Court of Session, Lord Clyde. [1991]3 Med LR 16. Diana Brahams
Resistant malaria in Cambodia
Noticeboard
According to the World Health Organisation (March 16) "an extremely serious form of malaria, resistant to the usual drugs employed against the disease, is emerging in Cambodia, threatening than 16 000 soldiers of the United Nations peace-keeping force now entering the country". Quinine plus tetracycline, intravenous quinine, quinine tablets, and mefloquine are all scarce, and resistance seems to be developing to most treatments, including mefloquine. The UN peace-keeping force, when in malarious areas for a long time, will take doxycycline, which has so far not been used (or misused) in this area. This agent offers protection against initial malaria infection and there is so far no hard evidence of resistance. The soldiers will also be instructed to use insect repellants, wear long-sleeved clothes, and sleep under impregnated bednets. Since doxycycline kills the natural bacteria in the gut, the cause must be stopped now and again to allow the flora to regrow. "If Cambodia cannot get enough drugs, and support for the improvement of health care and training", says Dr Hiroshi Nakajima, directorgeneral of WHO, "there may be a tragedy". He was referring to 360 000 Cambodian refugees in Thailand, half of them under 15 years of age, who will return to Cambodia in a few weeks. WHO is supporting the re-establishment of an antimalaria programme in Cambodia, with funding from the UK Overseas Development Administration, non-governmental organisations, and other agencies. The UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) is studying the mechanisms of malaria drug resistance in the area, seeking means to reverse it, and intensifying work on new drugs and vaccines.
more
Tamoxifen trial controversy
Uncertainty about the hepatotoxicity of tamoxifen in man has led the Medical Research Council to modify its support for the proposed trial on the prevention of cancer; the MRC has decided that it can now support only a trial restricted to women aged over 40 with a fourfold or greater relative risk of breast cancer-ie, women with a first-degree relative with bilateral breast cancer; women with two first-degree relatives with breast cancer; women with an existing breast carcinoma; and women with hyperplasia in a benign breast tumour. Because of the accumulation of tamoxifen in the blood in man, the dose proposed for the trial (20 mg/day) could be considered equivalent to that which has induced liver tumours in rats (tumours have not developed in mice exposed to tamoxifen). These tumours do not follow the normal pattern of steroid-induced hepatocarcinogenesis and are highly malignant. Earlier this month the drug was reported to induce covalent DNA adducts in rats;2 and this finding has been confirmed at the MRC toxicology unit. Persistence of such bonds between DNA and tamoxifen could result in mutations, as happened in the rats, which had been given tamoxifen for only 1, 3, or 6 days. There are insufficient data on the use of tamoxifen in man for firm conclusions to be drawn on the hepatotoxic effects of the drug. Very few healthy women have been taking the drug for more than 5 years. There were two liver tumours mentioned in a follow-up study of new tumours in Swedish trial. The possible links between the drug and uterine or ovarian5 cancer were taken into account during the risk-benefit assessment of tamoxifen when the trial was planned. More recently, an association with retinopathy has been reported.’ The MRC’s toxicology unit will be investigating as a matter of urgency the mechanism of the toxicity of the drug and the differences between animal species in the metabolism of tamoxifen. The Imperial Cancer Research Fund and the Cancer Research Campaign have decided to go ahead with the trial as planned, without the support of the MRC. They have expressed surprise at the MRC’s decision, which they say overrides the judgments of the
Research
pulls
The Medical Resesarch Council corporate plan last year was described by the Council’s secretary as a plan for contraction. This year the picture is healthier, says Dr Dai Rees-the planning figures have increased over those announced last year by 12-5 million for 1992-93, 21-3million for 1993-94 and 31million for 1994-95.1 However, he adds that these figures are insufficient to return the volume of research to that funded in 1990-91. These sums do not include the monies that the Universities Funding Council have handed over to the Research Councils to administer. Dr Rees gives the categorical assurance that the sum transferred to the MRC will be used for work in higher education institutes.
736
The Council’s scientific strategy is this time presented in full in a separate volumeonly summaries of the scientific strategy are given in the volume on management planning. Still underlying the Council’s scientific strategy and its approach to strengthening clinical research is the integration of such research with basic science in "centres of critical mass". Emphasis is being put on the genetic, molecular, and cellular bases of disease through the new initiatives on the genetic and neurosciences approach to human health. The Department of Health’s new research and development strategy has focused attention on the needs of the UK public. A formal concordat has been established between the two organisations and the Council’s strategy committee now functions in two modes--a "science-push" mode when making decisions from the scientific opportunities perspective, and a "needs-pull" mode when considering health needs. The Council is also undertaking a review of its research board structure. Final arrangements will be made after discussion with the scientific community. For the moment the tropical medicine research board has been disbanded. The future development of tropical medicine research is under active consideration and such research now comes under the responsibility of the board on major systems/organs. 1. Corporate Plan 1992. London: Medical Research Council. 1992. Pp 49. 2. Scientific Strategy 1992. London: Medical Research Council. 1992. Pp 83.
Valves revisited The US Food and Drug Administration has asked Shiley Inc, the manufacturer of Bjork-Shiley heart valves, to notify patients and physicians that the risk of fracture for some sizes of these valves may be higher than previously thought-perhaps as much as five times higher for the larger 60° convexo-concave (CC) valves. Valve fracture is often fatal. The FDA now believes that the long-term risk of fractures of these large valves may occasionally be high enough to warrant consideration of the replacement of intact prostheses. "When a critical device such as a heart valve is found to have a problem that could result in death or serious injury, FDA has an obligation to see that doctors and patients are notified so that they can consider the new information in deciding on a course of action", said Dr David Kessler, the FDA Commissioner. About 23 000 people in the USA and Canada have 60°CC Bjork-Shiley valves, which were withdrawn from sale in 1986. The FDA has received about 350 reports of 60°CC fractures among some 82 000 implanted valves world wide. The agency had requested Shiley to notify patients with these valves of the fracture problems in a programme begun in 1990, when it first became aware of some risk of fracture, but replacement of intact valves was not recommended because the risk of reoperation was then thought to outweigh by far the risk of fracture. The risk of fracture depends on the age of the patient, valve size, and valve position and may be as high as 08% annually for people under 50 with large mitral valve
prostheses. Decisions about possible replacement of heart valves should be made according to individual cases, on the basis of the new fracture figures and the patient’s medical status, lifestyle, and wishes. The FDA has asked Shiley to inform all patients with CC heart valves of the increased risk of fracture and to advise those for whom risk estimates have changed to discuss the new information with their doctors. Patients not affected by the new figures will be reassured that these new data do not apply to them. Shiley has also been asked to write to physicians, enclosing a copy of the study upon which the higher estimates are based and discussing the option of valve replacement. "It is important to remember that this new risk information applies only to Shiley CC valves, not to other makes and models", said James S. Benson, director of FDA’s Center for Devices and Radiological Health. "Even with the CC valves, the increased fracture risk is confined to certain size valves. The risk figures have not appreciably changed for CC valve patients who have the smaller size valves". In the UK, a registry for patients with Bjork-Shiley CC valves was established in January through the charity MedicAlert, and all cardiothoracic surgeons, cardiologists, and general practitioners have been provided with the latest information on the risks of strut failure and the role of the patient registry. Anyone in the UK
(including patients themselves) who requires more information implant registry can obtain it free of charge on 0800 220386. Meanwhile, attempts by clinicians to achieve a panEuropean register of implanted heart valves seem to have run into difficulties with funding,’ and the amount of information available to patients with prosthetic valves still varies widely from country to
about the
countrv-
1. Chamberlain D, Oldershaw P. British Cardiac Society newsletter. Br Heart J 1992; 67: 278.
Jabs
Nearly 200 years after Jenner’s first faltering steps towards vaccination against smallpox comes a new genetic technique for eliciting immunity to some types of protein.’ Tang et al inoculated gold microprojectiles coated with a plasmid expressing the human growth hormone (hGH) gene into the ear skin of mice. This manipulation is achieved with a hand-held biolistic system that can propel DNA directly into cells. Subsequent antibody generation depended on the strain of mouse inoculated, although the primary response could be augmented with further hGH plasmid microinjection. Antibodies to human al-antitrypsin (hAAT) were also formed when hATT complementary DNA was introduced in the same way. Injection of plasmids by a needle-and-syringe technique produced no response. This method has the advantage that the often difficult steps of protein purification and combination with adjuvant, both routinely required for vaccine development, are eliminated. 1.
Tang D, DeVit M, Johnston SA. Genetic immunization is eliciting an immune response. Nature 1992; 356: 152-54.
a
simple
method for
Duty to protect? An application for leave to seek judicial review was made in the high court last week against the UK General Medical Council (GMC). The application seeks to force the GMC to publish its list of European certified specialists and to declare that, by withholding such a list from public scrutiny, it may be failing in its duty to protect patients from practitioners who are not fully trained. The application also aims to make the GMC reinstate the European Community requirement of "completion" of a defined period of supervised clinical experience for accreditation as a specialist (see Lancet Feb 8, p 356). Among other things the application further seeks a declaration that it is unlawful for the GMC to delegate its statutory powers to the Joint Committee on Higher Medical Training.
IVIG guidelines If there were a league table of number of review articles over the past 5 years on the uses of a therapeutic agent, intravenous immune globulin (IVIG) must come pretty near the top-not surprisingly, in view of the increasing number and diversity of the disorders for which its value has been investigated. Even intractable epilepsy has been treated with IVIG, although immune globulin has no anticonvulsant properties. Last month the American Society of Hospital Pharmacists’ Commission on Therapeutics published its therapeutic guidelines for IVIG.’ The review covers the FDA-approved indications (chronic lymphatic leukaemia, primary immune deficiency disorders, and idiopathic thrombocytopenic purpura) as well as Kawasaki’s disease, neonatal sepsis, autoimmune disease (such as autoimmune neutropenia, autoimmune haemolytic anaemia, rheumatoid arthritis, systemic lupus erythematosus), IgG subclass deficiencies, intractable epilepsy, thermal injury, cytomegalovirus infection, and human immunodeficiency virus (HIV) infection. The Commission recommends 1000-2000 mg/kg over 2-5 days for adults with HIV-associated idiopathic thrombocytopenic purpura but says that the value of IVIG for children with this disorder is not clear. on Therapeutics ASHP therapeutic guidelines for intravenous immune globulin. Clin Pharmacy 1992; 11: 117-36.
1. ASHP Commission
the diagnosis of testicular tumour and metastasis was made. Treatment was unsuccessful and he died 7 years later. The judge said that for the case to succeed it would have to be established that tumour was present during the critical period in 1978. Some of the symptoms were consistent with a tumour, but there was nothing so evident as to persuade him that it was clearly demonstrable, at least during the early months. Applying a 1955 decision approved by the House of Lords in 1984, the judge said that it was not enough to say in defence simply that the matter was one of clinical judgment, but it was equally not enough for a pursuer to show that there was an error in clinical judgment. There was no doubt the doctors should have been aware of the possibility of tumour, and awareness of that possibility is reflected in the medical records. The judge decided that no valid criticism could be made of the registrar or consultant in not deciding on surgery when the patient was first an inpatient or when he attended as an outpatient between February and April, 1978. There was an infective condition in January, 1978, and it was not impossible that the patient had gonorrhoea. Even had negligence been proved, the claim would have been time-barred, the judge said. It was not until November, 1982, that the patient consulted solicitors with a view to a claim for negligence and it was not until July, 1985, that a summons was served.
charities, the Committee on Safety of Medicines (which last month approved the use of tamoxifen as a prophylactic agent), the US Food and Drug Administration (which last month gave approval for a similar trial, which will be formally announced next month), and the Government ministers who have given approval for the trial. Originally the plan was to recruit women in the UK from fifteen centres (1000 women each); six of these are MRC funded. The numbers will probably be made up by an Australian trial that will follow the UK protocol and that has been approved, and by recruitment in a couple of European countries that have expressed interest in the trial. Although there will now be no MRC involvement in the trial, the toxicology unit studies will continue. Dr Dai Rees, secretary to the MRC states that"... the MRC has no wish to spread alarm amongst women taking tamoxifen for proven cases of breast cancer.... The trial in question seeks to use the drug in well women. We have taken the view that until more evidence is obtained to inform better risk/benefit calculations the best course is to proceed with caution". cancer
Nayfield SG, Karp JE, Ford LG, Dorr FA, Kramer BS. Potential role of tamoxifen in prevention of breast cancer. J Natl Cancer Inst 1991, 83: 1450-59. 2. Han X, Liehr JG. Induction of covalent DNA adducts m rodents by tamoxifen. Cancer Res 1992; 52: 1360-63. 3. Fornander T, Rutqvist LE, Cedermark B, et al. Adjuvant tamoxifen in early breast cancer: occurrence of new primary tumours. Lancet 1989; i: 117-20. 4. Altaras MM, Avirath R, Beyth Y. Tamoxifen-associated endometrial carcinoma in postmenopausal breast cancer patients. Gynecol Oncol 1991; 41: 270. 5. Spicer DV, Pike MC, Henderson BE. Ovarian cancer and long-term tamoxifen in premenopausal women. Lancet 1991; 337: 1414. 6. Bentley CR, Davies G, Aclimondos WA. Tamoxifen retinopathy, a rare but serious complication, Br Med J 1992; 304: 495-96. 1.
Phillips v Grampian Health Board. Scottish Court of Session, Lord Clyde. [1991]3 Med LR 16. Diana Brahams
Resistant malaria in Cambodia
Noticeboard
According to the World Health Organisation (March 16) "an extremely serious form of malaria, resistant to the usual drugs employed against the disease, is emerging in Cambodia, threatening than 16 000 soldiers of the United Nations peace-keeping force now entering the country". Quinine plus tetracycline, intravenous quinine, quinine tablets, and mefloquine are all scarce, and resistance seems to be developing to most treatments, including mefloquine. The UN peace-keeping force, when in malarious areas for a long time, will take doxycycline, which has so far not been used (or misused) in this area. This agent offers protection against initial malaria infection and there is so far no hard evidence of resistance. The soldiers will also be instructed to use insect repellants, wear long-sleeved clothes, and sleep under impregnated bednets. Since doxycycline kills the natural bacteria in the gut, the cause must be stopped now and again to allow the flora to regrow. "If Cambodia cannot get enough drugs, and support for the improvement of health care and training", says Dr Hiroshi Nakajima, directorgeneral of WHO, "there may be a tragedy". He was referring to 360 000 Cambodian refugees in Thailand, half of them under 15 years of age, who will return to Cambodia in a few weeks. WHO is supporting the re-establishment of an antimalaria programme in Cambodia, with funding from the UK Overseas Development Administration, non-governmental organisations, and other agencies. The UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) is studying the mechanisms of malaria drug resistance in the area, seeking means to reverse it, and intensifying work on new drugs and vaccines.
more
Tamoxifen trial controversy
Uncertainty about the hepatotoxicity of tamoxifen in man has led the Medical Research Council to modify its support for the proposed trial on the prevention of cancer; the MRC has decided that it can now support only a trial restricted to women aged over 40 with a fourfold or greater relative risk of breast cancer-ie, women with a first-degree relative with bilateral breast cancer; women with two first-degree relatives with breast cancer; women with an existing breast carcinoma; and women with hyperplasia in a benign breast tumour. Because of the accumulation of tamoxifen in the blood in man, the dose proposed for the trial (20 mg/day) could be considered equivalent to that which has induced liver tumours in rats (tumours have not developed in mice exposed to tamoxifen). These tumours do not follow the normal pattern of steroid-induced hepatocarcinogenesis and are highly malignant. Earlier this month the drug was reported to induce covalent DNA adducts in rats;2 and this finding has been confirmed at the MRC toxicology unit. Persistence of such bonds between DNA and tamoxifen could result in mutations, as happened in the rats, which had been given tamoxifen for only 1, 3, or 6 days. There are insufficient data on the use of tamoxifen in man for firm conclusions to be drawn on the hepatotoxic effects of the drug. Very few healthy women have been taking the drug for more than 5 years. There were two liver tumours mentioned in a follow-up study of new tumours in Swedish trial. The possible links between the drug and uterine or ovarian5 cancer were taken into account during the risk-benefit assessment of tamoxifen when the trial was planned. More recently, an association with retinopathy has been reported.’ The MRC’s toxicology unit will be investigating as a matter of urgency the mechanism of the toxicity of the drug and the differences between animal species in the metabolism of tamoxifen. The Imperial Cancer Research Fund and the Cancer Research Campaign have decided to go ahead with the trial as planned, without the support of the MRC. They have expressed surprise at the MRC’s decision, which they say overrides the judgments of the
Research
pulls
The Medical Resesarch Council corporate plan last year was described by the Council’s secretary as a plan for contraction. This year the picture is healthier, says Dr Dai Rees-the planning figures have increased over those announced last year by 12-5 million for 1992-93, 21-3million for 1993-94 and 31million for 1994-95.1 However, he adds that these figures are insufficient to return the volume of research to that funded in 1990-91. These sums do not include the monies that the Universities Funding Council have handed over to the Research Councils to administer. Dr Rees gives the categorical assurance that the sum transferred to the MRC will be used for work in higher education institutes.
736
The Council’s scientific strategy is this time presented in full in a separate volumeonly summaries of the scientific strategy are given in the volume on management planning. Still underlying the Council’s scientific strategy and its approach to strengthening clinical research is the integration of such research with basic science in "centres of critical mass". Emphasis is being put on the genetic, molecular, and cellular bases of disease through the new initiatives on the genetic and neurosciences approach to human health. The Department of Health’s new research and development strategy has focused attention on the needs of the UK public. A formal concordat has been established between the two organisations and the Council’s strategy committee now functions in two modes--a "science-push" mode when making decisions from the scientific opportunities perspective, and a "needs-pull" mode when considering health needs. The Council is also undertaking a review of its research board structure. Final arrangements will be made after discussion with the scientific community. For the moment the tropical medicine research board has been disbanded. The future development of tropical medicine research is under active consideration and such research now comes under the responsibility of the board on major systems/organs. 1. Corporate Plan 1992. London: Medical Research Council. 1992. Pp 49. 2. Scientific Strategy 1992. London: Medical Research Council. 1992. Pp 83.
Valves revisited The US Food and Drug Administration has asked Shiley Inc, the manufacturer of Bjork-Shiley heart valves, to notify patients and physicians that the risk of fracture for some sizes of these valves may be higher than previously thought-perhaps as much as five times higher for the larger 60° convexo-concave (CC) valves. Valve fracture is often fatal. The FDA now believes that the long-term risk of fractures of these large valves may occasionally be high enough to warrant consideration of the replacement of intact prostheses. "When a critical device such as a heart valve is found to have a problem that could result in death or serious injury, FDA has an obligation to see that doctors and patients are notified so that they can consider the new information in deciding on a course of action", said Dr David Kessler, the FDA Commissioner. About 23 000 people in the USA and Canada have 60°CC Bjork-Shiley valves, which were withdrawn from sale in 1986. The FDA has received about 350 reports of 60°CC fractures among some 82 000 implanted valves world wide. The agency had requested Shiley to notify patients with these valves of the fracture problems in a programme begun in 1990, when it first became aware of some risk of fracture, but replacement of intact valves was not recommended because the risk of reoperation was then thought to outweigh by far the risk of fracture. The risk of fracture depends on the age of the patient, valve size, and valve position and may be as high as 08% annually for people under 50 with large mitral valve
prostheses. Decisions about possible replacement of heart valves should be made according to individual cases, on the basis of the new fracture figures and the patient’s medical status, lifestyle, and wishes. The FDA has asked Shiley to inform all patients with CC heart valves of the increased risk of fracture and to advise those for whom risk estimates have changed to discuss the new information with their doctors. Patients not affected by the new figures will be reassured that these new data do not apply to them. Shiley has also been asked to write to physicians, enclosing a copy of the study upon which the higher estimates are based and discussing the option of valve replacement. "It is important to remember that this new risk information applies only to Shiley CC valves, not to other makes and models", said James S. Benson, director of FDA’s Center for Devices and Radiological Health. "Even with the CC valves, the increased fracture risk is confined to certain size valves. The risk figures have not appreciably changed for CC valve patients who have the smaller size valves". In the UK, a registry for patients with Bjork-Shiley CC valves was established in January through the charity MedicAlert, and all cardiothoracic surgeons, cardiologists, and general practitioners have been provided with the latest information on the risks of strut failure and the role of the patient registry. Anyone in the UK
(including patients themselves) who requires more information implant registry can obtain it free of charge on 0800 220386. Meanwhile, attempts by clinicians to achieve a panEuropean register of implanted heart valves seem to have run into difficulties with funding,’ and the amount of information available to patients with prosthetic valves still varies widely from country to
about the
countrv-
1. Chamberlain D, Oldershaw P. British Cardiac Society newsletter. Br Heart J 1992; 67: 278.
Jabs
Nearly 200 years after Jenner’s first faltering steps towards vaccination against smallpox comes a new genetic technique for eliciting immunity to some types of protein.’ Tang et al inoculated gold microprojectiles coated with a plasmid expressing the human growth hormone (hGH) gene into the ear skin of mice. This manipulation is achieved with a hand-held biolistic system that can propel DNA directly into cells. Subsequent antibody generation depended on the strain of mouse inoculated, although the primary response could be augmented with further hGH plasmid microinjection. Antibodies to human al-antitrypsin (hAAT) were also formed when hATT complementary DNA was introduced in the same way. Injection of plasmids by a needle-and-syringe technique produced no response. This method has the advantage that the often difficult steps of protein purification and combination with adjuvant, both routinely required for vaccine development, are eliminated. 1.
Tang D, DeVit M, Johnston SA. Genetic immunization is eliciting an immune response. Nature 1992; 356: 152-54.
a
simple
method for
Duty to protect? An application for leave to seek judicial review was made in the high court last week against the UK General Medical Council (GMC). The application seeks to force the GMC to publish its list of European certified specialists and to declare that, by withholding such a list from public scrutiny, it may be failing in its duty to protect patients from practitioners who are not fully trained. The application also aims to make the GMC reinstate the European Community requirement of "completion" of a defined period of supervised clinical experience for accreditation as a specialist (see Lancet Feb 8, p 356). Among other things the application further seeks a declaration that it is unlawful for the GMC to delegate its statutory powers to the Joint Committee on Higher Medical Training.
IVIG guidelines If there were a league table of number of review articles over the past 5 years on the uses of a therapeutic agent, intravenous immune globulin (IVIG) must come pretty near the top-not surprisingly, in view of the increasing number and diversity of the disorders for which its value has been investigated. Even intractable epilepsy has been treated with IVIG, although immune globulin has no anticonvulsant properties. Last month the American Society of Hospital Pharmacists’ Commission on Therapeutics published its therapeutic guidelines for IVIG.’ The review covers the FDA-approved indications (chronic lymphatic leukaemia, primary immune deficiency disorders, and idiopathic thrombocytopenic purpura) as well as Kawasaki’s disease, neonatal sepsis, autoimmune disease (such as autoimmune neutropenia, autoimmune haemolytic anaemia, rheumatoid arthritis, systemic lupus erythematosus), IgG subclass deficiencies, intractable epilepsy, thermal injury, cytomegalovirus infection, and human immunodeficiency virus (HIV) infection. The Commission recommends 1000-2000 mg/kg over 2-5 days for adults with HIV-associated idiopathic thrombocytopenic purpura but says that the value of IVIG for children with this disorder is not clear. on Therapeutics ASHP therapeutic guidelines for intravenous immune globulin. Clin Pharmacy 1992; 11: 117-36.
1. ASHP Commission