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British Medical Journal apologises to biotech company
SCIENCE AND MEDICINE
NEWS British Medical Journal apologises to biotech company he editor of the British Medical Journal, Richard Smith, apologised on June 7 for errors made in publishing a misleading study on burns in cancer patients caused by photodynamic therapy (PDT) and temoporfin (Foscan; Scotia Holdings, UK), which prompted the Scottish biotechnology company’s share price to fall by 26%. PDT uses non-thermal lasers to activate injected photosensitive drugs, such as temoporfin, to treat cancers non-invasively. Temoporfin is Scotia’s flagship product and a licence for the drug is expected in October. However, Shehan Hettiaratchy from the West Midlands Regional Burns Unit, University Hospital, Birmingham, UK, and colleagues recently reported that six out of 14 (43%) healthy men given a single dose of temoporfin “developed partial thickness burns after minimal exposure to light” (BMJ 2000; 320: 1245). These findings were immediately reported in the Financial Times newspaper on May 6. “The share price fell on the day of the announcement by 27%, which was just over £30 million [of the company’s market capitalisation]”, stated Rob Dow, chief executive officer of Scotia. Richard Bryce, medical director of Scotia, noted that of the 957 patients given PDT and temoporfin so far,
T
appropriate care by avoiding extravaonly 2·3% had serious adverse drug sation at the time of injection and reactions attributable to photosensisubsequently with proper shielding of tivity and burns. Had the BMJ the area”. included these data, as is their normal Hettiaratchy has countered by saypolicy when reporting adverse drug ing that “we are not suggesting that events, it would have been clear the true incidence of burns with that Hettiaratchy’s results were an Foscan is 43%—this anomaly. Smith was just the inciadmitted that Rights were not dence in the group despite requesting of patients that were the data from Scotia granted to include referred to us”. He it was not included this image in also states that “this in the published was not a pure study. electronic media. extravasation injury. Dow did not Please refer to the The burns occurred know why 46% on exposure to sunof Hettiaratchy’s printed journal. light and photopatients should have activation, 2 weeks had such serious after the drug was burns. “We believe given”. Hettiaratchy the drug has also stressed that extravasated at the Temoporfin back on track irrespective of drug site of the administration problems, the medical injection . . . and now Hettiaratchy community should be aware has agreed that he also believes that is that “this is a rare and serious what happened”, says Dow. complication”. Anil D’Cruz from the Tata MemDow now hopes that Scotia’s share orial Hospital, Mumbai, India, who is price will recover to 340p per doing similar temoporfin-mediated share—trading at 133p on June PDT studies agreed with Dow and 13—by March 2002 for a £50 million noted that in their studies of 21 bond issue. However he stated that patients over the past 15 months Scotia reserves its position with “treatment was well tolerated and regard to future legal action. resulted in no major side-effects”. D’Cruz suggested that the burns “could well have been avoided with Haroon Ashraf
Red tape restraining UK medical science, say leading researchers
A
n increase in the bureaucracy regulating the use of animals in research is threatening the future of UK medical science, according to a group of leading researchers. In an open letter to the UK Minister for Science (June 12), 110 signatories, including five winners of the Nobel Prize for Medicine, state that the UK’s system of regulating animalbased research is becoming “more lengthy, complex, bureaucratic, and inflexible than in other leading scientific nations”. Bruce Matthews (University of Bristol, UK), one of the signatories of the letter, told The Lancet that
THE LANCET • Vol 355 • June 17, 2000
the time it takes to make minor amendments to existing project licences was of particular concern. Mike Spyer (University College London, UK), another signatory, agreed: “We do not want the law watered down, but rather the bureaucratic process sped up”. The lengthy delays can be particularly demoralising for young researchers on short-term contracts, points out Spyer, especially in the current climate of “publish or perish”. He also notes that it is virtually impossible for foreign scientists to do experiments while on short visits to UK laboratories.
Importantly, the authors stress that they fully endorse efforts to improve animal welfare in the UK: “We are not suggesting, and would not support, any reduction in the welfare of laboratory animals”. However, with many scientists facing delays of 6 months or more before they can start experimentation, the signatories warn that “it appears inevitable that a substantial part of the UK’s research effort, in many vital areas, will either become uncompetitive, or be forced abroad”. James Butcher
2139
For personal use only. Not to be reproduced without permission of The Lancet.
NEWS British Medical Journal apologises to biotech company he editor of the British Medical Journal, Richard Smith, apologised on June 7 for errors made in publishing a misleading study on burns in cancer patients caused by photodynamic therapy (PDT) and temoporfin (Foscan; Scotia Holdings, UK), which prompted the Scottish biotechnology company’s share price to fall by 26%. PDT uses non-thermal lasers to activate injected photosensitive drugs, such as temoporfin, to treat cancers non-invasively. Temoporfin is Scotia’s flagship product and a licence for the drug is expected in October. However, Shehan Hettiaratchy from the West Midlands Regional Burns Unit, University Hospital, Birmingham, UK, and colleagues recently reported that six out of 14 (43%) healthy men given a single dose of temoporfin “developed partial thickness burns after minimal exposure to light” (BMJ 2000; 320: 1245). These findings were immediately reported in the Financial Times newspaper on May 6. “The share price fell on the day of the announcement by 27%, which was just over £30 million [of the company’s market capitalisation]”, stated Rob Dow, chief executive officer of Scotia. Richard Bryce, medical director of Scotia, noted that of the 957 patients given PDT and temoporfin so far,
T
appropriate care by avoiding extravaonly 2·3% had serious adverse drug sation at the time of injection and reactions attributable to photosensisubsequently with proper shielding of tivity and burns. Had the BMJ the area”. included these data, as is their normal Hettiaratchy has countered by saypolicy when reporting adverse drug ing that “we are not suggesting that events, it would have been clear the true incidence of burns with that Hettiaratchy’s results were an Foscan is 43%—this anomaly. Smith was just the inciadmitted that Rights were not dence in the group despite requesting of patients that were the data from Scotia granted to include referred to us”. He it was not included this image in also states that “this in the published was not a pure study. electronic media. extravasation injury. Dow did not Please refer to the The burns occurred know why 46% on exposure to sunof Hettiaratchy’s printed journal. light and photopatients should have activation, 2 weeks had such serious after the drug was burns. “We believe given”. Hettiaratchy the drug has also stressed that extravasated at the Temoporfin back on track irrespective of drug site of the administration problems, the medical injection . . . and now Hettiaratchy community should be aware has agreed that he also believes that is that “this is a rare and serious what happened”, says Dow. complication”. Anil D’Cruz from the Tata MemDow now hopes that Scotia’s share orial Hospital, Mumbai, India, who is price will recover to 340p per doing similar temoporfin-mediated share—trading at 133p on June PDT studies agreed with Dow and 13—by March 2002 for a £50 million noted that in their studies of 21 bond issue. However he stated that patients over the past 15 months Scotia reserves its position with “treatment was well tolerated and regard to future legal action. resulted in no major side-effects”. D’Cruz suggested that the burns “could well have been avoided with Haroon Ashraf
Red tape restraining UK medical science, say leading researchers
A
n increase in the bureaucracy regulating the use of animals in research is threatening the future of UK medical science, according to a group of leading researchers. In an open letter to the UK Minister for Science (June 12), 110 signatories, including five winners of the Nobel Prize for Medicine, state that the UK’s system of regulating animalbased research is becoming “more lengthy, complex, bureaucratic, and inflexible than in other leading scientific nations”. Bruce Matthews (University of Bristol, UK), one of the signatories of the letter, told The Lancet that
THE LANCET • Vol 355 • June 17, 2000
the time it takes to make minor amendments to existing project licences was of particular concern. Mike Spyer (University College London, UK), another signatory, agreed: “We do not want the law watered down, but rather the bureaucratic process sped up”. The lengthy delays can be particularly demoralising for young researchers on short-term contracts, points out Spyer, especially in the current climate of “publish or perish”. He also notes that it is virtually impossible for foreign scientists to do experiments while on short visits to UK laboratories.
Importantly, the authors stress that they fully endorse efforts to improve animal welfare in the UK: “We are not suggesting, and would not support, any reduction in the welfare of laboratory animals”. However, with many scientists facing delays of 6 months or more before they can start experimentation, the signatories warn that “it appears inevitable that a substantial part of the UK’s research effort, in many vital areas, will either become uncompetitive, or be forced abroad”. James Butcher
2139
For personal use only. Not to be reproduced without permission of The Lancet.