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Ophthalmologists on trial for alleged research fraud
POLICY AND PEOPLE
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n April 10 it was announced that two ophthalmologists in Düsseldorf, Germany, had admitted to having enrolled 1300 patients in a trial without having obtained informed consent. Both are currently the subjects of a judicial inquiry; each stands accused of premeditated maltreatment. If found guilty each doctor is liable for a fine or up to 5 years’ imprisonment. Seven patients who underwent cataract surgery on March 15 this year at the Dominicus Krankenhaus in Düsseldorf became infected with Pseudomonas aeruginosa. In two patients, the infection led to the loss of the affected eye. According to the prosecuting attorney, Johannes Mocken, the patients were probably infected via either the fluid or the apparatus used to rinse the eye during surgery. Only when the source of the infection was being investigated did it become clear that the patients were being included in a trial coordinated by the University of Magdeburg that had started 18 months previously. The trial was investigating the effect of including gentamicin in the eye-rinsing fluid. At this point of the inquiry it is not clear whether the infected patients were in the placebo arm. “However”, said Mocken, “regardless of possible complications, there is a case of premeditated maltreatment, when patients are not informed that they are participating in an experimental study”.
Wim Weber
Measles epidemic sweeps through Afghanistan fighting last year. As a result, the n epidemic of measles is continuhealth services have been completely ing to spread in at least seven destroyed. The district remains war-ravaged Afghanistan’s 30 unreachable because the roads are provinces. As of April 19, thousands of snow bound or heavily mined. Relief children have been affected and there agencies are using donkeys to attempt have been at least 1200 measlesto transfer supplies to the district. related deaths. The case–fatality rate is In six of Darra estimated by WHO Souf’s villages to be 8–13%. alone, measles has The lack of even affected more than the most basic 1800 children and health services resulted in 260 means that “thoudeaths. Yet a WHO sands of children are team commissioned paying the price to investigate the of being poor, epidemic in Darra malnourished, and Souf could not u n i m m u n i s e d ” , Unvaccinated and vulnerable travel because of the warned WHO’s impassable roads. Afghanistan spokesperson, Abdi In Tolak district of western Momin. “The death toll could be far Afghanistan, the disease has affected higher than this”, he added. Despite more than 600 children of whom its enormity, the epidemic has had about 100 have died in recent weeks. almost no international attention. A similar outbreak in Kush Rabat More than half of the deaths have Sango district has affected over 1000 been reported from Afghanistan’s children and killed another 79 since northwestern province, Badakhshan, the outbreak started in late February. which borders Tajikistan. The worstWhile measles continued its march hit district has been Darwaz, where at across Afghanistan, the Global least 320 children have died. To avoid Alliance for Vaccines and the snow-blocked roads, relief workers Immunisation (GAVI), a public– carried supplies across the Oxus river private coalition, announced that to Tajikistan and then re-crossed into by spending US$350 million a year Afghanistan to reach the affected it would reach half of the 25 million areas. In the Shegnan district of children born every year in world’s Badakhshan, more than 70 measlespoor countries. On April 11, Gro related deaths have been reported. Harlem Brundtland, WHO DirectorAnother district, Kishem, has recently General and chairman of the GAVI reported 500 cases and 35 deaths. board addressed the US Senate, Other measles-hit districts include which is considering a Clinton Khawhan, Kalafgan, Chal, and Administration request of $50 million Ishkamish. Almost all these districts for GAVI. have no health services. Darra Souf district in Samangan province was the scene of the worst Khabir Ahmad
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Panos Pictures
Ophthalmologists on trial for alleged research fraud
Australian coroner recommends rules for abortions resulting in live births n April 10, coroner Greg Cavanaugh (Northern Territory, Australia), handed down his findings in the case of “Baby J”, a fetus born alive after a termination attempt last year. He recommended that uniform protocols or laws be put in place to deal with such situations. In this case, the doctor concerned had instructed the nursing team to induce labour in a woman carrying a fetus whose gestational age was thought to be 19 weeks. The age was subsequently estimated to be about 22 weeks. The fetus was born alive, and lived for 80 minutes after being placed in a kidney dish. A midwife who heard
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THE LANCET • Vol 355 • April 22, 2000
the baby cry contacted the doctor who refused to come. The doctor provided no advice, nor did other hospital staff. In evidence, the doctor denied that he had any duty towards Baby J. While finding the doctor’s failure to respond had not contributed to the death, the coroner criticised the doctor for failing to take any responsibility. The coroner recommended that children who survive termination procedures be, at the very least, assessed for gestational age by a medical practitioner, preferably a paediatrician. Deaths in these instances, he said, should be reported to the coroner. He stated that: “it is important not
to let semantics confuse the matter. The deceased was not, and should not be described as, a ‘fetus’, an ‘abortus’, a ‘living fetus’ or a ‘living abortus’, a ‘non-viable fetus’, a ‘live neonate’, or anything else that diminishes her status as a human being. . . . Similarly, the fact that her death was inevitable should also not have the same result. The old, the infirm, the sick, and the terminally ill are all entitled to proper medical care and palliative attention. In my view, newly born unwanted and premature babies should have the same rights.” Bebe Loff, Stephen Cordner
1439
O
n April 10 it was announced that two ophthalmologists in Düsseldorf, Germany, had admitted to having enrolled 1300 patients in a trial without having obtained informed consent. Both are currently the subjects of a judicial inquiry; each stands accused of premeditated maltreatment. If found guilty each doctor is liable for a fine or up to 5 years’ imprisonment. Seven patients who underwent cataract surgery on March 15 this year at the Dominicus Krankenhaus in Düsseldorf became infected with Pseudomonas aeruginosa. In two patients, the infection led to the loss of the affected eye. According to the prosecuting attorney, Johannes Mocken, the patients were probably infected via either the fluid or the apparatus used to rinse the eye during surgery. Only when the source of the infection was being investigated did it become clear that the patients were being included in a trial coordinated by the University of Magdeburg that had started 18 months previously. The trial was investigating the effect of including gentamicin in the eye-rinsing fluid. At this point of the inquiry it is not clear whether the infected patients were in the placebo arm. “However”, said Mocken, “regardless of possible complications, there is a case of premeditated maltreatment, when patients are not informed that they are participating in an experimental study”.
Wim Weber
Measles epidemic sweeps through Afghanistan fighting last year. As a result, the n epidemic of measles is continuhealth services have been completely ing to spread in at least seven destroyed. The district remains war-ravaged Afghanistan’s 30 unreachable because the roads are provinces. As of April 19, thousands of snow bound or heavily mined. Relief children have been affected and there agencies are using donkeys to attempt have been at least 1200 measlesto transfer supplies to the district. related deaths. The case–fatality rate is In six of Darra estimated by WHO Souf’s villages to be 8–13%. alone, measles has The lack of even affected more than the most basic 1800 children and health services resulted in 260 means that “thoudeaths. Yet a WHO sands of children are team commissioned paying the price to investigate the of being poor, epidemic in Darra malnourished, and Souf could not u n i m m u n i s e d ” , Unvaccinated and vulnerable travel because of the warned WHO’s impassable roads. Afghanistan spokesperson, Abdi In Tolak district of western Momin. “The death toll could be far Afghanistan, the disease has affected higher than this”, he added. Despite more than 600 children of whom its enormity, the epidemic has had about 100 have died in recent weeks. almost no international attention. A similar outbreak in Kush Rabat More than half of the deaths have Sango district has affected over 1000 been reported from Afghanistan’s children and killed another 79 since northwestern province, Badakhshan, the outbreak started in late February. which borders Tajikistan. The worstWhile measles continued its march hit district has been Darwaz, where at across Afghanistan, the Global least 320 children have died. To avoid Alliance for Vaccines and the snow-blocked roads, relief workers Immunisation (GAVI), a public– carried supplies across the Oxus river private coalition, announced that to Tajikistan and then re-crossed into by spending US$350 million a year Afghanistan to reach the affected it would reach half of the 25 million areas. In the Shegnan district of children born every year in world’s Badakhshan, more than 70 measlespoor countries. On April 11, Gro related deaths have been reported. Harlem Brundtland, WHO DirectorAnother district, Kishem, has recently General and chairman of the GAVI reported 500 cases and 35 deaths. board addressed the US Senate, Other measles-hit districts include which is considering a Clinton Khawhan, Kalafgan, Chal, and Administration request of $50 million Ishkamish. Almost all these districts for GAVI. have no health services. Darra Souf district in Samangan province was the scene of the worst Khabir Ahmad
A
Panos Pictures
Ophthalmologists on trial for alleged research fraud
Australian coroner recommends rules for abortions resulting in live births n April 10, coroner Greg Cavanaugh (Northern Territory, Australia), handed down his findings in the case of “Baby J”, a fetus born alive after a termination attempt last year. He recommended that uniform protocols or laws be put in place to deal with such situations. In this case, the doctor concerned had instructed the nursing team to induce labour in a woman carrying a fetus whose gestational age was thought to be 19 weeks. The age was subsequently estimated to be about 22 weeks. The fetus was born alive, and lived for 80 minutes after being placed in a kidney dish. A midwife who heard
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THE LANCET • Vol 355 • April 22, 2000
the baby cry contacted the doctor who refused to come. The doctor provided no advice, nor did other hospital staff. In evidence, the doctor denied that he had any duty towards Baby J. While finding the doctor’s failure to respond had not contributed to the death, the coroner criticised the doctor for failing to take any responsibility. The coroner recommended that children who survive termination procedures be, at the very least, assessed for gestational age by a medical practitioner, preferably a paediatrician. Deaths in these instances, he said, should be reported to the coroner. He stated that: “it is important not
to let semantics confuse the matter. The deceased was not, and should not be described as, a ‘fetus’, an ‘abortus’, a ‘living fetus’ or a ‘living abortus’, a ‘non-viable fetus’, a ‘live neonate’, or anything else that diminishes her status as a human being. . . . Similarly, the fact that her death was inevitable should also not have the same result. The old, the infirm, the sick, and the terminally ill are all entitled to proper medical care and palliative attention. In my view, newly born unwanted and premature babies should have the same rights.” Bebe Loff, Stephen Cordner
1439