radiation disasters: an international biobank plan is vital

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Comment 1042 www.thelancet.com/oncology Vol 14 October 2013 3 Australian Institute of Health and Welfare and Australasian Association of Cancer Registries 2012. Cancer in Australia: an overview, 2012. Cancer series no. 74. Cat. no. CAN 70. Canberra: AIHW. 4 Food and Drug Administration. Fast track, accelerated approval and priority review. http://www.fda.gov/forconsumers/byaudience/ forpatientadvocates/speedingaccesstoimportantnewtherapies/ ucm128291.htm#compare 2012 (accessed Sept 4, 2013). 5 Sidhu R, Rong A, Dahlberg S. Evaluation of progression-free survival as a surrogate endpoint for survival in chemotherapy and targeted agent metastatic colorectal cancer trials. Clin Cancer Res 2013; 19: 969–76. 6 Miksad RA, Zietemann V, Gothe R, et al. Progression-free survival as a surrogate endpoint in advanced breast cancer. Int J Techno Assess Health Care 2008; 24: 371–83. 7 Whitehead SJ, Ali S. Health outcomes in economic evaluation: the QALY and utilities. Br Med Bull 2010; 96: 5–21. 8 Hicks SC, James RE, Wong N, Tebbutt NC, Wilson K, for the Australasian Gastro-Intestinal Trials Group. A case study evaluation of ethics review systems for multicentre clinical trials. Med J Aust 2009; 191: 280–82. Getty Images Radiation disasters: an international biobank plan is vital Biobanks are essential for diagnostic, epidemiological, and research purposes after radiation disasters, but this type of research has a history of delays, specifically in the establishment of important resources, including tissue repositories, after the rare occurrence of these events. We argue that one key lesson from Chernobyl and Fukushima has still not been learned: it is essential to agree on a proactive international plan for a radiation disaster biobank and accompanying data collection before the next disaster occurs. The nuclear power station at Chernobyl in Ukraine underwent catastrophic failure on April 26, 1986. In addition to dozens of immediate casualties, thousands of people were exposed to high doses of radiation. The most common result of this exposure has been thyroid cancer among those exposed to the radiation as children, with an estimated 9000 incidences of cancer caused by the event. After the disaster, many individual research projects using samples from those affected by Chernobyl were done, with some scientific effort being wasted; 1 cooperation was then recognised to be necessary to avoid duplication of research. However, organisational difficulties occurred between various entities including WHO, the European Community, and the US National Cancer Institute in the establishment of the Chernobyl Tissue Bank, which did not begin operations until 1998. The establishment of this biobank has enabled a great deal of important research about the public health effects of the disaster, particularly regarding the development of thyroid cancer in children and foetuses exposed to the radiation. 2 However, if the biobank had been set up immediately, this research could have been done much more quickly, with potentially significant improvements in the diagnosis and treatment of those affected during the first 10 years, as well as those presenting with cancer many years later. Although several important lessons were learned from Chernobyl, one area in which no advances were made was in planning for research after a similar disaster. When the Fukushima Daiichi power plant in Japan underwent catastrophic failure after the tsunami on March 11, 2011, radiation was again released into the environment without any biobanking plan in place. More than half a million people were evacuated from areas surrounding the plant, but more than 2 years after the disaster no biobank research has assessed the public health effects of the disaster. This absence of research might be due in part to the belief that the health risk to those exposed to radiation in this disaster is very small, with an absolute increase of 1% in the risk of developing any type of cancer for infants exposed to radiation. 3 However, this belief could be mistaken, as an increase in the incidence of thyroid cancer among children in Fukushima prefecture has already been reported. 4 Furthermore, daily leaks of 300 tonnes of irradiated groundwater from the plant, as well as a highly radioactive leak in August, 2013 (level 3 on the International Nuclear and Radiological Event Scale), indicate that the disaster is ongoing, and that it could yet have substantial effects on public health. 5 If biobank research had commenced immediately after the initial disaster, prediction of these effects would be more easy. Chernobyl and Fukushima both represent missed or delayed opportunities for highly important research. How can the next opportunity be fully exploited? All successful biobanks are governed by clear rules and procedures, and are ideally designed around the

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1042 www.thelancet.com/oncology Vol 14 October 2013

3 Australian Institute of Health and Welfare and Australasian Association of Cancer Registries 2012. Cancer in Australia: an overview, 2012. Cancer series no. 74. Cat. no. CAN 70. Canberra: AIHW.

4 Food and Drug Administration. Fast track, accelerated approval and priority review. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm#compare 2012 (accessed Sept 4, 2013).

5 Sidhu R, Rong A, Dahlberg S. Evaluation of progression-free survival as a surrogate endpoint for survival in chemotherapy and targeted agent metastatic colorectal cancer trials. Clin Cancer Res 2013; 19: 969–76.

6 Miksad RA, Zietemann V, Gothe R, et al. Progression-free survival as a surrogate endpoint in advanced breast cancer. Int J Techno Assess Health Care 2008; 24: 371–83.

7 Whitehead SJ, Ali S. Health outcomes in economic evaluation: the QALY and utilities. Br Med Bull 2010; 96: 5–21.

8 Hicks SC, James RE, Wong N, Tebbutt NC, Wilson K, for the Australasian Gastro-Intestinal Trials Group. A case study evaluation of ethics review systems for multicentre clinical trials. Med J Aust 2009; 191: 280–82.

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Radiation disasters: an international biobank plan is vitalBiobanks are essential for diagnostic, epidemiological, and research purposes after radiation disasters, but this type of research has a history of delays, specifi cally in the establishment of important resources, including tissue repositories, after the rare occurrence of these events. We argue that one key lesson from Chernobyl and Fukushima has still not been learned: it is essential to agree on a proactive international plan for a radiation disaster biobank and accompanying data collection before the next disaster occurs.

The nuclear power station at Chernobyl in Ukraine underwent catastrophic failure on April 26, 1986. In addition to dozens of immediate casualties, thousands of people were exposed to high doses of radiation. The most common result of this exposure has been thyroid cancer among those exposed to the radiation as children, with an estimated 9000 incidences of cancer caused by the event. After the disaster, many individual research projects using samples from those aff ected by Chernobyl were done, with some scientifi c eff ort being wasted;1 cooperation was then recognised to be necessary to avoid duplication of research. However, organisational diffi culties occurred between various entities including WHO, the European Community, and the US National Cancer Institute in the establishment of the Chernobyl Tissue Bank, which did not begin operations until 1998. The establishment of this biobank has enabled a great deal of important research about the public health eff ects of the disaster, particularly regarding the development of thyroid cancer in children and foetuses exposed to the radiation.2 However, if the biobank had been set up immediately, this research could have been done much more quickly, with potentially signifi cant improvements in the diagnosis and treatment of

those aff ected during the fi rst 10 years, as well as those presenting with cancer many years later.

Although several important lessons were learned from Chernobyl, one area in which no advances were made was in planning for research after a similar disaster. When the Fukushima Daiichi power plant in Japan underwent catastrophic failure after the tsunami on March 11, 2011, radiation was again released into the environment without any biobanking plan in place. More than half a million people were evacuated from areas surrounding the plant, but more than 2 years after the disaster no biobank research has assessed the public health effects of the disaster. This absence of research might be due in part to the belief that the health risk to those exposed to radiation in this disaster is very small, with an absolute increase of 1% in the risk of developing any type of cancer for infants exposed to radiation.3 However, this belief could be mistaken, as an increase in the incidence of thyroid cancer among children in Fukushima prefecture has already been reported.4 Furthermore, daily leaks of 300 tonnes of irradiated groundwater from the plant, as well as a highly radioactive leak in August, 2013 (level 3 on the International Nuclear and Radiological Event Scale), indicate that the disaster is ongoing, and that it could yet have substantial effects on public health.5 If biobank research had commenced immediately after the initial disaster, prediction of these effects would be more easy.

Chernobyl and Fukushima both represent missed or delayed opportunities for highly important research. How can the next opportunity be fully exploited? All successful biobanks are governed by clear rules and procedures, and are ideally designed around the

Comment

www.thelancet.com/oncology Vol 14 October 2013 1043

needs of researchers while protecting the rights of donors.6 To design and approve the right regulations takes a long time, but disaster biobanks need to be created quickly to provide maximum benefit, meaning that any rules and procedures should be agreed well in advance of any disaster. Biobank procedures are normally connected to where the specimens are obtained, but we have no way of knowing where the next disaster will be. Therefore, any agreement governing the creation of a radiation disaster biobank would have to enable the creation of a biobank, including provision for the international sharing of samples and data regardless of the location of the disaster. The establishment of a biobank for international radiation disaster research would be best facilitated by proactive creation of an agreement to enable research and clinical care that is not subject to national borders. International organisations such as WHO should take the lead to form a consortium of countries that agree in advance to the disaster biobank framework and will benefit from general support during any future radiation disasters. It is also important to remember that biobanks are not merely collections of samples, but also need matched data from individuals to enable research. Such data could include the likely dose of radiation exposure, which is calculated using several factors: the place where the person was living or working, whether windows were open, whether contaminated food was consumed, intake of iodine prophylaxis, general medical history, and other demographical data. One problem in research after radiation disasters is the uncertainty about radioactivity doses, which are very important for making correlations between cancer development and level of exposure. Often, only an individual’s place of residence is known, and the dose they actually received can only be guessed at. Therefore, the distribution of questionnaires and measurement of radiation doses needs to be planned systematically in advance, together with sample collections (mostly of tissue and blood), so that these can take place during the urgent rescue phase or as close as possible to it. A substantial coordination effort is also necessary in terms of long-term follow-up of different types of cancers. Childhood thyroid cancer has a 30% recurrence rate 20–30 years after the first cancer, but by the time of relapse adults are no longer in touch

with their paediatric cancer centres and are often lost to follow-up. Any international agreement would also have to enable the long-term follow-up of any patients. The panel lists the key components of such an agreement.

If a biobank for international radiation disaster research is established, it will represent an important step both in disaster management planning and in international research cooperation. One reason for the current absence of such a plan might be the hope that no such disaster occurs again. Nonetheless, to again have insuffi cient planning and capacity for diagnosis and research after a future disaster would itself be a catastrophe.

*David Shaw, Bernice ElgerInstitute for Biomedical Ethics, University of Basel, Bernoulistrasse 28, 4056 Basel, Switzerland (DS, BE)[email protected]

We declare that we have no confl icts of interest

1 Thomas G, Unger K, Krznaric M, et al. The Chernobyl Tissue Bank—a repository for biomaterial and data used in integrative and systems biology modeling the human response to radiation. Genes 2012; 3: 278–90.

2 Thomas GA, Bethel JA, Galpine A, Mathieson W, Krznaric M, Unger K. Integrating research on thyroid cancer after Chernobyl—the Chernobyl Tissue Bank. Clin Oncol 2011; 23: 276–81.

3 World Health Organization. Health risk assessment from the nuclear accident after the 2011 Great East Japan Earthquake and Tsunami based on a preliminary dose estimation (2013). http://apps.who.int/iris/bitstream/10665/78218/1/9789241505130_eng.pdf (accessed Aug 23, 2013).

4 RT News. Disturbing thyroid cancer rise in Fukushima minors. Aug 21, 2013. http://rt.com/news/fukushima-children-thyroid-cancer-783/ (accessed Aug 23, 2013).

5 McCurry J. Fukushima warning: danger level at nuclear plant jumps to ‘serious’. The Guardian, Aug 21, 2013. http://www.theguardian.com/environment/2013/aug/21/leap-fukushima-danger-ranking (accessed Aug 23, 2013).

6 Vaught J, Kelly A, and Hewitt R. A review of international biobanks and networks: success factors and key benchmarks. Biopreserv Biobank 2009; 7: 143–50.

Panel: Essential components of a biobank for international radiation disaster research

• Agreement to enable rapid gathering of samples• Agreement to enable rapid collection of data• Agreement to share samples and data internationally • Agreement to share results of any research with other

countries• Agreement to enable long-term follow-up of aff ected

patients• Agreement to obtain informed consent and protect

anonymity of data