bioethics concerns in regulating large dna collections: the israeli experience david gurwitz...
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Bioethics Concerns in Regulating Large DNA Collections:The Israeli Experience
David GurwitzNational Laboratory for the Genetics of Israeli Populations
Sackler Faculty of Medicine, Tel-Aviv [email protected]
ABC, Bangkok, Thailand, March 19, 2007
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Jews immigrated to Israel from Asian, African and European countries, from communities that were genetically isolated for 1000 – 2000 years
Israeli Arabs include groups with minimal admixture:Palestinians, Bedouine, Druze
This ethnic diversity is important in clinicla genetics and pharmacogenetics research
Israelis Are Ethnically Diverse
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Jewish immigration to Israel: 1948 - 2005(thousands of immigrants)
854 (mostly recent)
345
273
171
130 76
61
52
59
43
3736
38 30
28
2624
18
10
10
84
24
2
2
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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
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Cell Lines in the NLGIP Collection
18%
7%
16%
27%
3%
29%
ArabsArabArabsAshkenazi Jews
Sephardic
North-African Jews
Oriental Jews
Ethiopian Jews
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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
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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:
Males1102 1106 1113 1116 1154 1162 1254 1267 1363 1369Females1121 1124 1128 1129 1131 1133 1163 1265 1282 1283
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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.
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DNA Samples distributed by NLGIP:By Ethnic Groups
Ashkenazi Jews44%
Arabs 15%
Sephardic Jews7%
North-African Jews16%
Oriental14%
Ethiopian4%
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DNA Samples distributed by NLGIP:By Countries
USA43%
Israel27%
Japan14%
UK7%
Canada5%
Italy3%
Others1%
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DNA Samples distributed by NLGIP:By Type of Institute
Universities66%
National Research Institutes28%
Other Research Centers 6%
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HN
COCH 3
OH
HN
COCH 3
OSO 3H
HN
COCH 3
OO CO 2H
OH
OHHO
Acetaminophen can be toxic!
Sulfation (35%)Glucuronidation (60%) N
O
COCH 3
CYP2E1(5%)
Toxic!
UGT GST
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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
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Heart failure in Caucasians vs. African-Americans
Exner et al. (2001) NEJM 344, 1351-1357
*Enalapril (ACE inhibitor) No advantage for African-Americans
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CYP2D6 & CYP2C19
Luo et al (2004) American Journal of Pharmacogenomics 4: 395-401
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Middle Eastern Origin of the JewsHammer et al. (2000) Proc Natl Acad Sci U S A 97, 6769-6774
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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.
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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.
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Refusal do donate to NLGIP:Women and >50 are more likely to donate
0%
10%
20%
30%
40%
50%
123
By GenderTotal34%
Men43%
Women28%
By Age
0%
10%
20%
30%
40%
50%
12345
18-3037%
31-4041%
41-5039%
51-6020%
Over 6025%
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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
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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?