- Email: [email protected]
Another HIV muddle?
355
genetic origins.
Information
given orally, the committee suggests,
should whenever possible be accompanied by written material, for which minimum standards should be set.
Counselling that explores the personal and family implications of infertility and its treatment is seen to be of particular importance to people receiving donated gametes. If more conventional treatments are inappropriate or fail, the step to acceptance of donor gamete techniques is very great, says the committee; the significance of this action must be fully understood and accepted by both partners. Since a high level of counselling skill and a detailed knowledge of infertility and its treatment are needed for implications counselling, this service must be provided by a trained infertility counsellor. Many people undergoing investigation and treatment for infertility need emotional support, and this need can be greatest when treatment is terminated without a pregnancy being achieved when a pregnancy is not viable. The committee suggests that support counselling may be needed throughout treatment, and it recommends that treatment centres should encourage the development of support groups, in addition to providing the services of professional counsellors. Finally, the guidelines recommend that treatment centres should be able to arrange referrals to psychiatrists or other specialists for patients with difficulties that have been exacerbated but not caused by infertility and its treatment. An appendix to the guidelines suggests what information the Human Fertilisation and Embryology Authority should include in leaflets for patients, general practitioners, and others—eg, causes of infertility, the different types of treatment, and what to tell a child about donation. Another gamete appendix makes recommendations about the content of short training courses for
or
infertility counselling. 1
Counselling for regulated infertility treatments Report of the King’s Fund Centre Counselling Committee London King’s Fund Centre, 1991. Available from Bailey Distribution Ltd, Learoyd Road, Mountfield Industrial Estate, New Romney, Kent TN28 8XU (telephone 0679 66905), price £5ISBN 0-903060817.
Doubts about tacrine
According to sceptical clinical pharmacologists, the reputation of drug shoots rapidly to dizzy heights, plummets to the depths of disillusionment, and then climbs some way back to its true position. Where stands tacrine (tetrahydroaminoacridine)? The dizziness phase is long gone, but discouraging investigations in the wake of the 1986 paper by William K. Summers and colleagues are a novel
not the end
of the story, and at least two further trials are awaited. A
negative French study in the EMJ in 1990 was, like the original positive one in the NE7M, much criticised. Such open evaluation is what publication is all about. However, the doubts now cast on the Summers trial by the US Food and Drug Administration are something that those caring for patients with Alzheimer’s disease will not welcome, not least because of the extraordinary delay. A long investigation by the FDA raised serious questions about the execution of the study. As a result this randomised, blind trial, lauded in an NEJM editorial as a "triumph for the scientific method", is now seen as "At best... the equivalent of uncontrolled, anecdotal clinical information". Since deliberate misrepresentation was not at
issue, Summers was asked to write a letter of clarification
journal. In April, 1989, he did so, but only in January, 1991, is the story told in the pages of the journal,’ and even then not in the form of the original letter, which was refused. In the mean time the study had been subjected to yet another scrutiny, by the University of California, Los Angeles. According to the FDA, documentation on randomisation and blindness was unconvincing or lacking, and global rating scales were worked out long after treatment. Summers et al deny all three allegations, so we do not know where this trial now stands-let alone where stands the drug.
to the
1 Relman
AS; Division of Neuropharmacological Drug Products, Office of New Drug Evaluation (I), Center for Drug Evaluation and Review; and Summers WK, Majovsh LM, Marsh GM, Tachiki K, Kling A Tacnne as a treatment for Alzheimer’s dementia N Engl J Med 1991; 324: 349; 349-52, and 352
Another HIV muddle? Last week the Independent newspaper described a "Million pound row over Aids test". This referred to a worry that a strain of virus used to develop an antibody test for HIV infection was not British (CBL1) but French (LAV). The issue of contamination by LAV and inadvertent use of virus supplied by the Pasteur Institute is potentially important commercially because of a stipulation that LAV could be used only for research. A similar dispute arose some years ago over the source of the US HIV strain HTLV-IIIB. Nature’s reporter, quoting the Los Alamos National Laboratory’s HIV sequence database, says that a 3% or less divergence in the env sequence indicates that isolates are from the same patient.’ For a time it looked as if two almost identical strains isolated from patients in New York and Nebraska disproved that rule, but contamination reared its head again to cloud that discussion too.2 Writing from the Chester Beatty Laboratories (CBL) in London, Prof R. A. Weiss notes divergences (for env and two other genes) of only 2% or so. "I cannot exclude the possibility of cross-contamination during its [CBLl] isolation and subsequent adaptation to grow in T-cell lines-both LAV-1 and HTLV-IIIB were propagated in our laboratory at that time".3.3 1 Aldhous P. Spectre of contamination. Nature 1991; 349: 359. 2 Concar D, Anderson C. Assumptions of AIDS inquiry challenged. Nature
3. 3 Weiss RA Provenance of HIV
strains.
1990; 347:
Nature 1991; 349: 374
Misconduct in medical research The machinery for investigating allegations of misconduct in research funded by the US National Institutes of Health is under fire.’ Wisely, the Royal College of Physicians of London, in its advice on how fraud and other misconduct should be prevented and investigated,2 avoids a heavy-handed, bureaucratic scheme, leaving control to institutions. A working-party chaired by Sir Raymond Hoffenberg and with Dr Stephen Lock, editor of the BM,7, as its honorary secretary, suggests that institutions such as university departments should appoint "screeners", who would receive allegations and decide whether or not an investigation is warranted. Those making allegations would be guaranteed anonymity, to start with. If in doubt, the screener could call upon up to three other scientists to help him. The institution itself should then set up the inquiry, if warranted. Natural justice has to be the order of the day (its neglect has been a concern in some US cases). A complication, less weighty than in the US perhaps, is the potential for defamation in such allegations. The obvious protection of "qualified privilege" requires, as the working-party notes, great care with the paperwork. The report is not really concerned with retraction of fraudulent material or with the shared responsibility of multiple authorship. These have been dealt with elsewhere, and the 1988 guidelines from Harvard Medical School form one of three useful appendices. A confirmed finding of misconduct by a medically qualified researchworker should be reported to the General Medical Council, and he or she would thus face a double jeopardy that many erring non-medical scientists would not. 1. Greenberg D The "fraud squad" is ruled out of bounds. Lancet 1991; 337: 289-90. 2 Fraud and misconduct in medical research: causes, investigation and prevention. London. Royal College of Physicians. 1991. Pp 18. £5 (£6 or US$12, including postage, overseas) ISBN 1-87324018X
Pop goes the needle Acupuncture has emerged as a valuable adjunct to conventional the prevention of nausea after general anaesthesia and cytotoxic chemotherapy and as a method of preventing reformed alcoholics from returning to their old ways. However, as with orthodox treatment, complementary therapy may cause iatrogenic disease. A report from California shows the danger of acupuncture for patients with asthma.1 A 31-year-old woman, with a history of childhood asthma, had a recurrence of symptoms during her second pregnancy. Despite treatment with immunotherapy for multiple
treatment for
genetic origins.
Information
given orally, the committee suggests,
should whenever possible be accompanied by written material, for which minimum standards should be set.
Counselling that explores the personal and family implications of infertility and its treatment is seen to be of particular importance to people receiving donated gametes. If more conventional treatments are inappropriate or fail, the step to acceptance of donor gamete techniques is very great, says the committee; the significance of this action must be fully understood and accepted by both partners. Since a high level of counselling skill and a detailed knowledge of infertility and its treatment are needed for implications counselling, this service must be provided by a trained infertility counsellor. Many people undergoing investigation and treatment for infertility need emotional support, and this need can be greatest when treatment is terminated without a pregnancy being achieved when a pregnancy is not viable. The committee suggests that support counselling may be needed throughout treatment, and it recommends that treatment centres should encourage the development of support groups, in addition to providing the services of professional counsellors. Finally, the guidelines recommend that treatment centres should be able to arrange referrals to psychiatrists or other specialists for patients with difficulties that have been exacerbated but not caused by infertility and its treatment. An appendix to the guidelines suggests what information the Human Fertilisation and Embryology Authority should include in leaflets for patients, general practitioners, and others—eg, causes of infertility, the different types of treatment, and what to tell a child about donation. Another gamete appendix makes recommendations about the content of short training courses for
or
infertility counselling. 1
Counselling for regulated infertility treatments Report of the King’s Fund Centre Counselling Committee London King’s Fund Centre, 1991. Available from Bailey Distribution Ltd, Learoyd Road, Mountfield Industrial Estate, New Romney, Kent TN28 8XU (telephone 0679 66905), price £5ISBN 0-903060817.
Doubts about tacrine
According to sceptical clinical pharmacologists, the reputation of drug shoots rapidly to dizzy heights, plummets to the depths of disillusionment, and then climbs some way back to its true position. Where stands tacrine (tetrahydroaminoacridine)? The dizziness phase is long gone, but discouraging investigations in the wake of the 1986 paper by William K. Summers and colleagues are a novel
not the end
of the story, and at least two further trials are awaited. A
negative French study in the EMJ in 1990 was, like the original positive one in the NE7M, much criticised. Such open evaluation is what publication is all about. However, the doubts now cast on the Summers trial by the US Food and Drug Administration are something that those caring for patients with Alzheimer’s disease will not welcome, not least because of the extraordinary delay. A long investigation by the FDA raised serious questions about the execution of the study. As a result this randomised, blind trial, lauded in an NEJM editorial as a "triumph for the scientific method", is now seen as "At best... the equivalent of uncontrolled, anecdotal clinical information". Since deliberate misrepresentation was not at
issue, Summers was asked to write a letter of clarification
journal. In April, 1989, he did so, but only in January, 1991, is the story told in the pages of the journal,’ and even then not in the form of the original letter, which was refused. In the mean time the study had been subjected to yet another scrutiny, by the University of California, Los Angeles. According to the FDA, documentation on randomisation and blindness was unconvincing or lacking, and global rating scales were worked out long after treatment. Summers et al deny all three allegations, so we do not know where this trial now stands-let alone where stands the drug.
to the
1 Relman
AS; Division of Neuropharmacological Drug Products, Office of New Drug Evaluation (I), Center for Drug Evaluation and Review; and Summers WK, Majovsh LM, Marsh GM, Tachiki K, Kling A Tacnne as a treatment for Alzheimer’s dementia N Engl J Med 1991; 324: 349; 349-52, and 352
Another HIV muddle? Last week the Independent newspaper described a "Million pound row over Aids test". This referred to a worry that a strain of virus used to develop an antibody test for HIV infection was not British (CBL1) but French (LAV). The issue of contamination by LAV and inadvertent use of virus supplied by the Pasteur Institute is potentially important commercially because of a stipulation that LAV could be used only for research. A similar dispute arose some years ago over the source of the US HIV strain HTLV-IIIB. Nature’s reporter, quoting the Los Alamos National Laboratory’s HIV sequence database, says that a 3% or less divergence in the env sequence indicates that isolates are from the same patient.’ For a time it looked as if two almost identical strains isolated from patients in New York and Nebraska disproved that rule, but contamination reared its head again to cloud that discussion too.2 Writing from the Chester Beatty Laboratories (CBL) in London, Prof R. A. Weiss notes divergences (for env and two other genes) of only 2% or so. "I cannot exclude the possibility of cross-contamination during its [CBLl] isolation and subsequent adaptation to grow in T-cell lines-both LAV-1 and HTLV-IIIB were propagated in our laboratory at that time".3.3 1 Aldhous P. Spectre of contamination. Nature 1991; 349: 359. 2 Concar D, Anderson C. Assumptions of AIDS inquiry challenged. Nature
3. 3 Weiss RA Provenance of HIV
strains.
1990; 347:
Nature 1991; 349: 374
Misconduct in medical research The machinery for investigating allegations of misconduct in research funded by the US National Institutes of Health is under fire.’ Wisely, the Royal College of Physicians of London, in its advice on how fraud and other misconduct should be prevented and investigated,2 avoids a heavy-handed, bureaucratic scheme, leaving control to institutions. A working-party chaired by Sir Raymond Hoffenberg and with Dr Stephen Lock, editor of the BM,7, as its honorary secretary, suggests that institutions such as university departments should appoint "screeners", who would receive allegations and decide whether or not an investigation is warranted. Those making allegations would be guaranteed anonymity, to start with. If in doubt, the screener could call upon up to three other scientists to help him. The institution itself should then set up the inquiry, if warranted. Natural justice has to be the order of the day (its neglect has been a concern in some US cases). A complication, less weighty than in the US perhaps, is the potential for defamation in such allegations. The obvious protection of "qualified privilege" requires, as the working-party notes, great care with the paperwork. The report is not really concerned with retraction of fraudulent material or with the shared responsibility of multiple authorship. These have been dealt with elsewhere, and the 1988 guidelines from Harvard Medical School form one of three useful appendices. A confirmed finding of misconduct by a medically qualified researchworker should be reported to the General Medical Council, and he or she would thus face a double jeopardy that many erring non-medical scientists would not. 1. Greenberg D The "fraud squad" is ruled out of bounds. Lancet 1991; 337: 289-90. 2 Fraud and misconduct in medical research: causes, investigation and prevention. London. Royal College of Physicians. 1991. Pp 18. £5 (£6 or US$12, including postage, overseas) ISBN 1-87324018X
Pop goes the needle Acupuncture has emerged as a valuable adjunct to conventional the prevention of nausea after general anaesthesia and cytotoxic chemotherapy and as a method of preventing reformed alcoholics from returning to their old ways. However, as with orthodox treatment, complementary therapy may cause iatrogenic disease. A report from California shows the danger of acupuncture for patients with asthma.1 A 31-year-old woman, with a history of childhood asthma, had a recurrence of symptoms during her second pregnancy. Despite treatment with immunotherapy for multiple
treatment for