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ABC, Bangkok, Thailand, March 19, 2007

Bioethics Concerns in Regulating L arge DNA Collections: The Israeli Experience David Gurwitz National Laboratory for the Genetics of Israeli Populations Sackler Faculty of Medicine, Tel-Aviv University gurwitz@post.tau.ac.il. ABC, Bangkok, Thailand, March 19, 2007. http://nlgip.tau.ac.il.

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ABC, Bangkok, Thailand, March 19, 2007

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  1. Bioethics Concerns in Regulating Large DNA Collections:The Israeli ExperienceDavid GurwitzNational Laboratory for the Genetics of Israeli Populations Sackler Faculty of Medicine, Tel-Aviv Universitygurwitz@post.tau.ac.il ABC, Bangkok, Thailand, March 19, 2007

  2. http://nlgip.tau.ac.il

  3. Israelis Are Ethnically Diverse Jews immigrated to Israel from Asian, African and European countries, from communities that were genetically isolated for 1000 – 2000 yearsIsraeli Arabs include groups with minimal admixture:Palestinians, Bedouine, Druze This ethnic diversity is important in clinicla genetics and pharmacogenetics research

  4. Jewish immigration to Israel: 1948 - 2005(thousands of immigrants) 854 (mostly recent) 26 18 171 2 24 38 30 273 8 4 10 43 61 2 10 76 345 130 24 36 37 28 52 59

  5. The National Laboratory for the Genetics of Israeli Populations • The repository includes about 2000 cell lines and matching DNA samples, representing the ethnic diversity of the populations of Israel • Blood samples for preparation of cell lines are obtained from adult individuals (>18 y) with informed consent • Supervised by the TAU IRB

  6. http://nlgip.tau.ac.il

  7. Cell Lines in the NLGIP Collection Ashkenazi Jews Arab Arabs Arabs Sephardic Ethiopian Jews North-African Jews Oriental Jews

  8. Major Public Collections of Human Cell Lines and DNA samples Repository Human Lines Disease Ethnicity • Coriell: ~8,000 genetic few • ATCC: ~1,500 cancer few • ECACC: ~25,000 genetic few • Genethon: ~43,000 genetic few • NLGIP: ~2,000 healthy all

  9. Coding the samples • DNA samples are coded by four-digit codes • The only information supplied : ethnicity and gender • Example for information accompanying a DNA shipment: Unrelated Ashkenazi donors: Males 1102 1106 1113 1116 1154 1162 1254 1267 1363 1369 Females 1121 1124 1128 1129 1131 1133 1163 1265 1282 1283

  10. From the NLGIP DNA Request Form: I, the undersigned, state that: - The requested cell lines/DNA samples will be used in my laboratory only for research. - The cell lines/DNA samples will not be further distributed to other laboratories or any scientists.

  11. DNA Samples distributed by NLGIP:By Ethnic Groups Arabs 15% Ashkenazi Jews 44% Ethiopian 4% Oriental 14% North-African Jews 16% Sephardic Jews 7%

  12. DNA Samples distributed by NLGIP:By Countries Italy 3% Canada 5% Israel 27% Others 1% UK 7% Japan 14% USA 43%

  13. DNA Samples distributed by NLGIP:By Type of Institute Other Research Centers 6% National Research Institutes 28% Universities 66%

  14. Acetaminophen can be toxic! Glucuronidation (60%) Sulfation (35%) UGT GST CYP2E1(5%) Toxic!

  15. Ethnic Diversity Studies are Essential for Drug Development • Polymorphic allele distribution differs between ethnic groups – - therefore Drug Safety and Efficacy also differs. • A KEY PROBLEM:Most clinical trials are performed in Caucasians • Asians and Africans do not always enjoy thesame level of safety and efficacy from new medicines

  16. Heart failure in Caucasians vs. African-Americans Exner et al. (2001) NEJM344, 1351-1357 *Enalapril (ACE inhibitor)  No advantage for African-Americans

  17. CYP2D6 & CYP2C19 Luo et al (2004) American Journal of Pharmacogenomics 4: 395-401

  18. Middle Eastern Origin of the Jews Hammer et al. (2000) Proc Natl Acad Sci U S A 97, 6769-6774

  19. NLGIP Informed Consent Form • The blood sample shall be used for preparing a cell line for research and is not related to my medical care. • The repository must maintain the confidentiality of the information resulting from the research, and use it without any identifying details.

  20. Informed Consent Form(cont.)- Altruism is empahsized • My refusal to participate in this research will not affect my medical treatment in any way. • The individual information from such studies shall not be made available to me. • I shall not receive any benefit in return for giving my blood sample and this consent.

  21. Refusal do donate to NLGIP:Women and >50 are more likely to donate By Gender By Age Women 28% Men 43% Total 34% 18-30 37% 31-40 41% 41-50 39% 51-60 20% Over 60 25%

  22. Reasons for refusal do donate(asked to choose from 5 optional replies) 60%  Not willing to donate too much blood 24%  Worried that their identity will be exposed 8%  Do not want their genes to be studied 4%  Find it immoral to perform genetic studies 4%  Other reasons

  23. Personalized Medicine:Can it co-exist with healthcare equity? • What should we do about people who do not have the ‘right genotype’ for available medicines? • How can society ensure better equity in healthcare, along with better, more personalized, medicine? *** Questions? gurwitz@post.tau.ac.il

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