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Ethical behaviour in clinical research—a lesson from the past
Editorial
Science Photo Library
COPD—more vigorous research needed
See Articles pages 991 and 997 See Series pages 1015, 1027, and 1038
For the UK Clinical Research Collaboration research spending exercise see http:// www.ukcrc.org/ researchcoordination/ healthresearchanalysis/ ukanalysis/
The Lancet today publishes a respiratory medicine theme issue to coincide with the 2011 European Respiratory Society annual congress in Amsterdam, Netherlands, on Sept 24–28. A clinical Series and two research articles report advances in chronic obstructive pulmonary disease (COPD). Andrea Gershon and colleagues estimated the disease burden at a population level in Ontario, Canada, and found that about one in four people older than 35 years was likely to be diagnosed with COPD during his or her lifetime; the risk was higher in men than in women, in those living in rural compared with urban areas, and in those in the lowest versus the highest socioeconomic groups. COPD is preventable, and known interventions, such as smoking cessation, exist. This lifetime risk study represents a simple means of communicating epidemiological concepts to the public, and could be used to promote health education programmes. The three Series papers review advances in COPD and provide new insights into immunology, future treatment,
use of biomarkers, and important controversies such as the role of inhaled corticosteroids and antibiotics. In the EASE trial, P L Shah and colleagues assessed the safety and efficacy of bronchoscopy to reduce lung volume in people with severe homogeneous emphysema (a subtype of COPD), but no benefit compared with sham surgery was noted at 6 months. Whether this strategy will be effective in this group of patients in the future remains unknown. COPD is expected to rise to the third leading cause of death worldwide by 2030, which especially endangers countries such as China and India, where smoking prevalence is rising and air pollution is serious. Yet respiratory diseases ranked only 13th in terms of research investment in a 2006 analysis in the UK—a striking discrepancy between disease burden and research spending. In addition to continued smoking cessation campaigns, more effort is needed to combat this disease whose low public profile belies its seriousness and ubiquity. ■ The Lancet
Science Photo Library
Ethical behaviour in clinical research—a lesson from the past
For the Commission’s proceedings and recommendations see http:// bioethics.gov/cms/sites/default/ files/IRP-Proceedings%20and%20 Recommendations_0.pdf
962
On Aug 29, the US Presidential Commission for the Study of Bioethical Issues concluded its investigation into USfunded studies done in Guatemala in the 1940s, with a final report still to come. The research in question involved intentional exposure of vulnerable populations to sexually transmitted diseases. The Commission concluded that the quality of the science was woefully poor and that ethical standards of the time were disregarded. The Guatemalan research, undertaken in 1946–1948, investigated whether taking penicillin after sex would protect against syphilis, gonorrhoea, and chancroid. The question was a medical priority at the time, especially for the military. Prisoners, patients with mental illness, soldiers, and children were involved—about 1300 people were deliberately exposed to the three diseases. Participants were infected by contact with prostitutes who were either already carrying the diseases or were purposely infected. Doctors also infected the prisoners by cutting into their skin and pouring bacteria onto the wounds created on their penises, faces, and arms. In some cases, infectious material was injected into victims’ spines.
The Commission compared the research done in Guatemala with studies that involved intentional exposure of prison inmates to gonorrhoea in Indiana, USA, in 1943. Many of the researchers involved in Indiana later worked on the project in Guatemala. In Indiana, the participants were fully briefed, volunteered, and gave informed consent, but in Guatemala, the people involved were not informed about the study’s purpose and did not provide consent. The Guatemalan project is a disgraceful chapter in the history of medicine. It is hoped that the Commission’s report will lead to a robust system of compensation for the harm suffered by participants in the course of this US-led clinical research programme. Today, companies and public-sector institutions based in developed countries commonly undertake clinical trials in developing countries, and the Guatemalan experiment is a potent reminder that prevailing standards must not only protect patients, but also ensure that the benefits of research are shared fairly with the communities involved. ■ The Lancet www.thelancet.com Vol 378 September 10, 2011
Science Photo Library
COPD—more vigorous research needed
See Articles pages 991 and 997 See Series pages 1015, 1027, and 1038
For the UK Clinical Research Collaboration research spending exercise see http:// www.ukcrc.org/ researchcoordination/ healthresearchanalysis/ ukanalysis/
The Lancet today publishes a respiratory medicine theme issue to coincide with the 2011 European Respiratory Society annual congress in Amsterdam, Netherlands, on Sept 24–28. A clinical Series and two research articles report advances in chronic obstructive pulmonary disease (COPD). Andrea Gershon and colleagues estimated the disease burden at a population level in Ontario, Canada, and found that about one in four people older than 35 years was likely to be diagnosed with COPD during his or her lifetime; the risk was higher in men than in women, in those living in rural compared with urban areas, and in those in the lowest versus the highest socioeconomic groups. COPD is preventable, and known interventions, such as smoking cessation, exist. This lifetime risk study represents a simple means of communicating epidemiological concepts to the public, and could be used to promote health education programmes. The three Series papers review advances in COPD and provide new insights into immunology, future treatment,
use of biomarkers, and important controversies such as the role of inhaled corticosteroids and antibiotics. In the EASE trial, P L Shah and colleagues assessed the safety and efficacy of bronchoscopy to reduce lung volume in people with severe homogeneous emphysema (a subtype of COPD), but no benefit compared with sham surgery was noted at 6 months. Whether this strategy will be effective in this group of patients in the future remains unknown. COPD is expected to rise to the third leading cause of death worldwide by 2030, which especially endangers countries such as China and India, where smoking prevalence is rising and air pollution is serious. Yet respiratory diseases ranked only 13th in terms of research investment in a 2006 analysis in the UK—a striking discrepancy between disease burden and research spending. In addition to continued smoking cessation campaigns, more effort is needed to combat this disease whose low public profile belies its seriousness and ubiquity. ■ The Lancet
Science Photo Library
Ethical behaviour in clinical research—a lesson from the past
For the Commission’s proceedings and recommendations see http:// bioethics.gov/cms/sites/default/ files/IRP-Proceedings%20and%20 Recommendations_0.pdf
962
On Aug 29, the US Presidential Commission for the Study of Bioethical Issues concluded its investigation into USfunded studies done in Guatemala in the 1940s, with a final report still to come. The research in question involved intentional exposure of vulnerable populations to sexually transmitted diseases. The Commission concluded that the quality of the science was woefully poor and that ethical standards of the time were disregarded. The Guatemalan research, undertaken in 1946–1948, investigated whether taking penicillin after sex would protect against syphilis, gonorrhoea, and chancroid. The question was a medical priority at the time, especially for the military. Prisoners, patients with mental illness, soldiers, and children were involved—about 1300 people were deliberately exposed to the three diseases. Participants were infected by contact with prostitutes who were either already carrying the diseases or were purposely infected. Doctors also infected the prisoners by cutting into their skin and pouring bacteria onto the wounds created on their penises, faces, and arms. In some cases, infectious material was injected into victims’ spines.
The Commission compared the research done in Guatemala with studies that involved intentional exposure of prison inmates to gonorrhoea in Indiana, USA, in 1943. Many of the researchers involved in Indiana later worked on the project in Guatemala. In Indiana, the participants were fully briefed, volunteered, and gave informed consent, but in Guatemala, the people involved were not informed about the study’s purpose and did not provide consent. The Guatemalan project is a disgraceful chapter in the history of medicine. It is hoped that the Commission’s report will lead to a robust system of compensation for the harm suffered by participants in the course of this US-led clinical research programme. Today, companies and public-sector institutions based in developed countries commonly undertake clinical trials in developing countries, and the Guatemalan experiment is a potent reminder that prevailing standards must not only protect patients, but also ensure that the benefits of research are shared fairly with the communities involved. ■ The Lancet www.thelancet.com Vol 378 September 10, 2011