■文献
Ｉ 身近な遺伝のはなし
II これだけは知っておこう遺伝子の基礎知識
III 現代の魔法・遺伝子工学
IV 遺伝子診断で何がわかる？
Ｖ 遺伝子治療は救世主になり得るか
次第に広がる対象疾患
フライングだった世界初の遺伝子治療
第一号患者は今
日本の一番乗りは？
半数以上を占めるがんへの応用
エイズの治療にも
金持ちのための治療になる！？
認められていない生殖細胞の操作
上がらぬ治療効果
治療のカギ握る運び屋
遺伝子治療は「急がば回れ」で
VI 壮大なヒト・ゲノム解析計画
VII 遺伝子でルーツがわかる
VIII遺伝子研究の未来
IX 遺伝子ア・ラ・カルト
◆Thompson, Larry 1993＊ Correcting the Code :
Inventing the Genetic Cure for the Human Body
＝19951016 清水信義監訳，
『遺伝子治療革命――ＤＮＡと闘った科学者たちの軌跡』
日本テレビ，550+7p. 2800 ※
＊ 訳書には原著の発行年が記されていない
◆Mckie, Robin 1988 The Genetic Gigsaw
Oxford University Press
＝19920417 長野敬訳，『遺伝子治療最前線』，日経サイエンス社，225p. 1600
◆Rosenberg, Steven A. ; Barry, John M. 1992
The Transformed Cell : Unlocking the Mysteries of Cancer
＝19930725 村松潔訳，
『ガンの神秘の扉をひらく――遺伝子治療の最前線から』
文藝春秋，475p. 2800 ※
●翻訳あるいは紹介のある論文
◆Holtug, Nils 1993 "Human Gene Therapy : Down the Slippy Slope ?",
Bioethics 7-5:402-419
「科学技術の発達と現代社会II」運営委員会編［1995:184-189］に
黒崎剛の要約「ヒト遺伝子治療――滑り坂を下るか？」 <268,428> ※
◆Wessels, Ulla 1994 "Genetic Engineering and Ethics in Germany"
A. Dyson and J. Harris eds. Ethics and Biotechnology, Routledge,
pp.230-258
加藤尚武編［1996:209-214］に山崎純の紹介
「Ｕ．ウェスルス「ドイツにおける遺伝子工学と倫理」
◆Anderson, W. French 1994 "Human Gene Therapy : Scientific and Ethical
Consideration", The Journal of Medicine and Philosophy 10
→E. Erwin et al. eds. 1994 Ethical Issues in Scientific Research,
Garland, pp.337-349
加藤尚武編［1996:215-219］に坂本知宏の紹介
「Ｗ．フレンチ・アンダーソン「ヒト遺伝子治療：科学的・倫理的考察」」
FDA PROPOSES A NEW PUBLIC DISCLOSURE RULE FOR GENE THERAPY AND XENOTRANSPLANTATION CLINICAL TRIALS
The Food and Drug Administration (FDA) today issued a proposed rule that would make publicly available
information on all new or ongoing clinical trials involving either gene therapy or xenotransplantation.
Under this proposed rule, published today in the Federal Register, FDA would provide public access to most
of the study design and safety information about these types of studies. FDA would not release
confidential business information or personal information related to study participants.
典oday痴 action is an important step in ensuring greater public confidence in these revolutionary
therapeutic technologies,・said FDA Commissioner, Jane E. Henney, M.D. ・Both of these technologies hold
great promise, but they may also pose a remote, but unique risk to the individuals who have volunteered to
participate in these types of studies. Our proposal will ensure that the public is fully informed as we
investigate these new public health opportunities and challenges.・
Human gene therapy is defined as the administration of genetic material to modify or manipulate the
expression of a gene product or to alter the biological properties of living cells for therapeutic use.
Cells may be modified outside the body (ex vivo) for subsequent administration to the subject or altered
in the body (in vivo) by gene therapy products given directly to the subject.
Xenotransplantation refers to any procedure that involves the transplantation, implantation, or infusion
into a human recipient of either (1) live cells, tissues, or organs from a nonhuman animal source; or (2)
human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal
cells, tissues, or organs.
The proposal will also ensure that FDA痴 policies for public access to this information are compatible
with those of other government agencies that oversee these types of research. Much of the information that
would be disclosed about gene therapy trials under this proposal is already publicly discussed in open
meetings of the Recombinant DNA Advisory Committee of the National Institutes of Health. Similarly,
information about xenotransplantation trials will also be publicly available through the Secretary
Advisory Committee on Xenotransplantation, which is being assembled by the Department of Health and Human
Services.
Under the rulemaking process there will a 90 day public comment period on this proposal. Written comments
may be submitted to:
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane
Room 10-61
HFA-305
Rockville, Maryland 20852
Comments can also be e-mailed to FDADOCKETS@OC.FDA.GOV. These comments will be considered in the
development of any final rule.