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US Senate probes gene-therapy trials
POLICY AND PEOPLE
Condom maker wins against pregnancy claim Even if the condom had been found “defective”, the judge said no damages were payable. The claimant had known of the “morning after pill” but had unreasonably failed to seek urgent medical advice from the general practitioner’s emergency deputising service although she wrongly believed the pill had to be taken within 24 hours. “An emergency does not mean that life is threatened. It merely means that it cannot wait until Monday and is of sufficient significance to require present attention”, noted the judgement. If she had obtained medical advice, she would have been prescribed the pill and avoided the unwanted pregnancy. The judge added that the House of Lords case of MacFarlane made it clear that it was the “policy of the law . . . to exclude . . . the costs of the upbringing of an uncovenanted child. That is equally applicable whether the claim is laid in negligence or breach of statutory duty”.
the unexpected increase in patients. The current crisis is not a new phenomenon, but exhausted hospital workers are saying that they will not accept the situation for much longer. Trade unions believe that at least US$1·5–2·2 billion is needed to create enough jobs to guarantee normal working conditions, but the government will allow an annual increase of only 2% to the US$38 billion allocated to public hospitals. The poor conditions and low salaries are preventing an increasing number of doctors from staying in public hospitals, with careers in private clinics or free practice posing a far more attractive option. To add to this many nurses leaving hospitals are not being replaced, which worsens the situation for those who choose to stay. Protesters intend to continue the strikes until concrete action, including the creation of enough jobs, is taken by the government.
n response to revelations of deficiencies in reporting of adverse events in gene-therapy trials (see Lancet Jan 29, p 329, 384), the US Senate Subcommittee on Public Health held a hearing on gene therapy on Feb 2. Chairman Senator Bill Frist (Republican, Tennessee) said: “Unfortunately, it is obvious that our oversight system is failing. I believe we will need to hold further hearings and consider legislative options that will enable us to ensure that patient safety is our number one priority.” The evidence presented included that of Paul Gelsinger, father of Jesse who died on Sept 17 in a trial of ornithine transcarbamylase gene therapy at the Institute for Human Gene Therapy (IHGT) at the University of Pennsylvania (Philadelphia, PA, USA). Gelsinger testified that he and his son had been told in July, 1999, of a previous patient’s 50% increase in her ability to eliminate ammonia after gene therapy—but at the December, 1999, meeting of the Recombinant DNA Advisory Committee of the NIH, he learned that the therapy had had no effect in that patient. Furthermore, Gelsinger learned only after the death of his son that there had been previous deaths of monkeys and adverse reactions in human beings in the IHGT ornithine transcarbamylase study, and additional adverse results in preclinical experiments conducted at pharmaceutical companies. “I learned that some companies were reporting only to the FDA, and labelling reports ‘proprietary’, in direct conflict with the NIH guidelines”, said Gelsinger. “In private conversations with an FDA director, I was told that they would like to see legislative changes to untie their hands so they could be less secretive, that they could do the right thing.” Although NIH approval is not required for most gene-therapy trials, federal guidelines still require that all adverse events are reported to both FDA and NIH, whether those events are due to the therapy itself or not. Although only FDA has the power to halt clinical trials, NIH has the power to revoke NIH funding. Both FDA and NIH officials testified that the primary responsibility for protecting patients’ welfare and for reporting adverse events lies with the investigators and with their institutions.
Denis Durand de Bousingen
Paul M Rowe
Science Photo Library
claim for damages arising from a split condom manufactured by LRC Products was dismissed in a UK High Court on Feb 2. Marian Richardson had claimed compensation for an unwanted pregnancy and the costs of rearing an “uncovenanted child” conceived following intercourse with her husband in November, 1993. Mr Justice Ian Kennedy stated that the fractured condom was not “defective” within the terms of the 1987 Consumer Protection Airtight case Act, which implements the European directive. The “longitudinal fast” fracture in the body of the condom had not been caused by ozone cracking before it left LRC’s factory premises. If this had occurred it did not cause the fracturing. The judge pointed out that LRC did not warrant that a condom will never fail and commented: “no-one has ever supposed that any method of contraception . . . will be 100% effective.” Large-scale studies showed “inexplicable failures”, though for health reasons did not study individual used condoms that had failed.
A
Diana Brahams
French hospital workers strike for better conditions
F
rench hospital workers have been on strike throughout France since mid-January in a demand for better working conditions and salaries. Protesters warn that budget restrictions and a reduction in available beds could have serious consequences for the quality and safety of treatment. A nationwide action was held on Jan 28, when 15 000 hospital workers and doctors held a demonstration in Paris and were joined by thousands of other protesters in major cities across France. Local actions and strikes are still being continued. Despite an increasing lack of health-care workers, budget regulations have prevented hospitals from creating new jobs, and have forced hospital staff to work extra hours, often without compensation. The staff shortage has mostly affected emergency and intensive-care units. The situation has been worsened by the influenza outbreak, which started at the beginning of the year, and has revealed a lack of beds for
560
US Senate probes gene-therapy trials
I
THE LANCET • Vol 355 • February 12, 2000
Condom maker wins against pregnancy claim Even if the condom had been found “defective”, the judge said no damages were payable. The claimant had known of the “morning after pill” but had unreasonably failed to seek urgent medical advice from the general practitioner’s emergency deputising service although she wrongly believed the pill had to be taken within 24 hours. “An emergency does not mean that life is threatened. It merely means that it cannot wait until Monday and is of sufficient significance to require present attention”, noted the judgement. If she had obtained medical advice, she would have been prescribed the pill and avoided the unwanted pregnancy. The judge added that the House of Lords case of MacFarlane made it clear that it was the “policy of the law . . . to exclude . . . the costs of the upbringing of an uncovenanted child. That is equally applicable whether the claim is laid in negligence or breach of statutory duty”.
the unexpected increase in patients. The current crisis is not a new phenomenon, but exhausted hospital workers are saying that they will not accept the situation for much longer. Trade unions believe that at least US$1·5–2·2 billion is needed to create enough jobs to guarantee normal working conditions, but the government will allow an annual increase of only 2% to the US$38 billion allocated to public hospitals. The poor conditions and low salaries are preventing an increasing number of doctors from staying in public hospitals, with careers in private clinics or free practice posing a far more attractive option. To add to this many nurses leaving hospitals are not being replaced, which worsens the situation for those who choose to stay. Protesters intend to continue the strikes until concrete action, including the creation of enough jobs, is taken by the government.
n response to revelations of deficiencies in reporting of adverse events in gene-therapy trials (see Lancet Jan 29, p 329, 384), the US Senate Subcommittee on Public Health held a hearing on gene therapy on Feb 2. Chairman Senator Bill Frist (Republican, Tennessee) said: “Unfortunately, it is obvious that our oversight system is failing. I believe we will need to hold further hearings and consider legislative options that will enable us to ensure that patient safety is our number one priority.” The evidence presented included that of Paul Gelsinger, father of Jesse who died on Sept 17 in a trial of ornithine transcarbamylase gene therapy at the Institute for Human Gene Therapy (IHGT) at the University of Pennsylvania (Philadelphia, PA, USA). Gelsinger testified that he and his son had been told in July, 1999, of a previous patient’s 50% increase in her ability to eliminate ammonia after gene therapy—but at the December, 1999, meeting of the Recombinant DNA Advisory Committee of the NIH, he learned that the therapy had had no effect in that patient. Furthermore, Gelsinger learned only after the death of his son that there had been previous deaths of monkeys and adverse reactions in human beings in the IHGT ornithine transcarbamylase study, and additional adverse results in preclinical experiments conducted at pharmaceutical companies. “I learned that some companies were reporting only to the FDA, and labelling reports ‘proprietary’, in direct conflict with the NIH guidelines”, said Gelsinger. “In private conversations with an FDA director, I was told that they would like to see legislative changes to untie their hands so they could be less secretive, that they could do the right thing.” Although NIH approval is not required for most gene-therapy trials, federal guidelines still require that all adverse events are reported to both FDA and NIH, whether those events are due to the therapy itself or not. Although only FDA has the power to halt clinical trials, NIH has the power to revoke NIH funding. Both FDA and NIH officials testified that the primary responsibility for protecting patients’ welfare and for reporting adverse events lies with the investigators and with their institutions.
Denis Durand de Bousingen
Paul M Rowe
Science Photo Library
claim for damages arising from a split condom manufactured by LRC Products was dismissed in a UK High Court on Feb 2. Marian Richardson had claimed compensation for an unwanted pregnancy and the costs of rearing an “uncovenanted child” conceived following intercourse with her husband in November, 1993. Mr Justice Ian Kennedy stated that the fractured condom was not “defective” within the terms of the 1987 Consumer Protection Airtight case Act, which implements the European directive. The “longitudinal fast” fracture in the body of the condom had not been caused by ozone cracking before it left LRC’s factory premises. If this had occurred it did not cause the fracturing. The judge pointed out that LRC did not warrant that a condom will never fail and commented: “no-one has ever supposed that any method of contraception . . . will be 100% effective.” Large-scale studies showed “inexplicable failures”, though for health reasons did not study individual used condoms that had failed.
A
Diana Brahams
French hospital workers strike for better conditions
F
rench hospital workers have been on strike throughout France since mid-January in a demand for better working conditions and salaries. Protesters warn that budget restrictions and a reduction in available beds could have serious consequences for the quality and safety of treatment. A nationwide action was held on Jan 28, when 15 000 hospital workers and doctors held a demonstration in Paris and were joined by thousands of other protesters in major cities across France. Local actions and strikes are still being continued. Despite an increasing lack of health-care workers, budget regulations have prevented hospitals from creating new jobs, and have forced hospital staff to work extra hours, often without compensation. The staff shortage has mostly affected emergency and intensive-care units. The situation has been worsened by the influenza outbreak, which started at the beginning of the year, and has revealed a lack of beds for
560
US Senate probes gene-therapy trials
I
THE LANCET • Vol 355 • February 12, 2000