ÃíÌܾðÊó

  1. ¥Û¡¼¥à
  2. ÃíÌܾðÊó

Î×¾²»î¸³¤Î¥·¥¹¥Æ¥à¤¬²õ¤ì¡¢°­¤¤Êý¸þ¤Ë¸þ¤«¤Ã¤Æ¤¤¤ë¡¼FDA¤Î¥Ù¥Æ¥é¥ó¿³ºº°å´±¤¬Í«Î¸

2014-03-05

(¥­¡¼¥ï¡¼¥É¡§Î×¾²»î¸³¥·¥¹¥Æ¥à¤ÎÇËþ¡¢FDA¿³ºº°å´±Í«Î¸¡¢°ÂÁ´À­·Ú»ë¡¢Ã¦Íî¥Ç¡¼¥¿¤Î°·¤¤)

Î×¾²»î¸³¥·¥¹¥Æ¥à¤¬²õ¤ì¡¢°­¤¤Êý¸þ¤Ë¸þ¤«¤Ã¤Æ¤¤¤ë¡£¤½¤¦¤·¤¿ÊƹñFDA¤Î¥Ù¥Æ¥é¥ó¿³ºº´±¤Îͫθ¤òBMJ»ïÅÅ»ÒÈÇ2013ǯ12·î5Æü¹æ¤¬ÅÁ¤¨¤Æ¤¤¤ë¡£

°Ê²¼¤Ï¤½¤ÎÍ׻ݤǤ¢¤ë¡£
-------------------------------------------------------------------------------------------------------

¡¡¥È¡¼¥Þ¥¹¡¦¥Þ¥ë¥Á¥Ë¥£¥¢¥¯»á¤Ï¡¢¥á¥¤¥è¡¼¡¦¥¯¥ê¥Ë¥Ã¥¯¤Ç·Ð¸³¤òÀѤó¤À°å»Õ¤Ç¡¢¤³¤Î11ǯ´Ö¤ÏFDA¤Ç¿³ºº°å´±¤ò̳¤á¤Æ¤¤¤ë¡£Èà¤Ï¡¢¡ÖÈ¿¹³¼Ô¡×(rebel)¤ä¡Ö°ìɤ¥ª¥ª¥«¥ß¡×(lone wolf)¤È¤Î¤¢¤À̾¤¬ÉÕ¤±¤é¤ì¤Æ¤ª¤ê¡¢¾å»Ê¤È¤·¤Ð¤·¤ÐÂÐΩ¤·¤Ê¤¬¤é¤â¿®Ç°¤ò¤â¤Ã¤Æ»Å»ö¤ò¤·¤Æ¤¤¤ë¡£¡Ö¼«Ê¬¤Ë¤ÏϢˮ¤Î¸ÛÍѼÔ(¸ø̳°÷)¤È¤·¤Æ¤Ç¤Ï¤Ê¤¯¡¢¤Ò¤È¤ê¤ÎÁ±°­¤ò¤ï¤­¤Þ¤¨¤¿(ethical)¸Ä¿Í¤È¤·¤Æ¡¢¸ø½°±ÒÀ¸¤ò¶¼¤«¤¹¥¨¥Ó¥Ç¥ó¥¹¤òÃΤ俤ʤé¤Ð¡¢¤½¤ì¤¬¼«Ê¬¤Ë³ä¤êÅö¤Æ¤é¤ì¤¿»Å»ö¤Ç¤¢¤ë¤«¤É¤¦¤«¤Ë´Ø¤ï¤ê¤Ê¤¯Êó¹ð¤¹¤ëµÁ̳¤¬¤¢¤ë¡×¤È¤ÎÈà¤Î¸ÀÍÕ¤¬¡¢¤½¤Î¤³¤È¤ò¼¨¤·¤Æ¤¤¤ë¡£

¡¡¡ÖÎ×¾²»î¸³¥·¥¹¥Æ¥à¤Ï²õ¤ì¤Æ¤¤¤ë¡£¤½¤·¤Æ¤Þ¤¹¤Þ¤¹°­¤¯¤Ê¤Ã¤Æ¤¤¤ë¡×¡ÝÈबBMJ»ï¤Ë¸ì¤Ã¤¿¸ÀÍդǤ¢¤ë¡£

¡¡Èà¤Ï¡¢FDA¤Î½Û´Ä´ï¡¦¿Õ¥Á¡¼¥à¤Ç¡¢´ë¶È¤¬Äó½Ð¤¹¤ë¥Ç¡¼¥¿¤òʬÀϤ·¤Æ¤­¤¿¡£Èà¤Ï¡¢¤½¤³¤Ç¤Î¥­¥ã¥ê¥¢·Ð¸³¤òÄ̤·¤Æ¡¢Î×¾²»î¸³¤Î·×²è¤«¤é¼Â»Ü¡¢¤½¤·¤Æ¥Ç¡¼¥¿¤ÎÅý·×²òÀϤ˻ê¤ë¤Þ¤Ç¡¢Î×¾²¸¦µæ¤ÎÁ´²áÄø¤òÈãȽŪ¤Ë¸·¤·¤¯¤ß¤ë´ã¤ò¿È¤ËÉÕ¤±¤¿¡£´ë¶È¤¬¼«¤éÄê¤á¤¿ÎÑÍý·û¾Ï¤ò¤â̵»ë¤·¤Æ¤¤¤ë¤È´¶¤¸¤ë¤³¤È¤¬¤·¤Ð¤·¤Ð¤¢¤Ã¤¿¡£ÈÎÇä¥Þ¥·¥ó¤Ë¤Ê¤Ã¤Æ¤·¤Þ¤Ã¤Æ¤¤¤ë¤Î¤Ç¤¢¤ë¡£Èà¤Ï¡¢´ë¶È¤Ë¹ṉ̃¤Î·ò¹¯¤ÈÀ¸Ì¿¤ËľÀÜ´Ø·¸¤¹¤ë¤³¤È¤ò°·¤Ã¤Æ¤¤¤ë¼«³Ð¤ò¿¼¤á¤ë¤è¤¦µá¤á¤Æ¤­¤¿¡£

¡¡ÈबÎϤòÆþ¤ì¤Æ¤­¤¿ÌäÂê¤Ë¡¢·ç¬ÃÍ ¢¨ ¤ÎÌäÂ꤬¤¢¤ë¡£Î×¾²»î¸³¤Ë¤Ï¡¢Â¿¤¯¤Î·ç¬Ãͤ¬¤¢¤ê¡¢¤½¤ì¤é¤¬Àµ¤·¤¯°·¤ï¤ì¤ë¤«Èݤ«¤¬·ëÏÀ¤ò¤âº¸±¦¤¹¤ë¡£Èà¤Ï¡¢¹³·ì¾®ÈĺޥÁ¥«¥°¥ì¥´¡¼¥ë¤Ê¤É¤Ç¡¢·ç¬Ãͤ¬Å¬ÀÚ¤ËÂн褵¤ì¤Æ¤¤¤Ê¤¤ÌäÂê¤òÄɵڤ·¤¿¤¬¡¢¾å»Ê¤Ï¡¢¤½¤¦¤·¤¿¤³¤È¤Ë¿¤¯¤Î»þ´Ö¤òÈñ¤ä¤¹Èà¤ò²÷¤¯»×¤ï¤Ê¤«¤Ã¤¿¡£

¡¡°ÂÁ´À­ÌäÂê¤Ï¡¢Èब¾å»Ê¤ÈÁ褤¤Ê¤¬¤é¤â¿´·ì¤òÃí¤¤¤Ç½Å»ë¤·¤Æ¤­¤¿ÌäÂê¤Ç¤¢¤ë¡£Á褤¤È¤Ê¤Ã¤¿ÂåɽŪ¤ÊÌäÂê¤Î¤Ò¤È¤Ä¤Ë¡¢¥í¥µ¥ë¥¿¥ó(¾¦ÉÊ̾¥Ë¥å¡¼¥í¥¿¥ó)¤ä¥Ð¥ë¥µ¥ë¥¿¥ó(¾¦ÉÊ̾¥Ç¥£¥ª¥Ð¥ó)¤Ê¤É¤Î¹ß°µºÞARB(¥¢¥ó¥¸¥ª¥Æ¥ó¥·¥ó­¶¼õÍÆÂÎÙɹ³ºÞ)¤Î¡¢È¯¤¬¤óÀ­ÌäÂ꤬¤¢¤ë¡£2010ǯ¤Î¥é¥ó¥»¥Ã¥È¡¦¥ª¡¼¥ó¥³¥í¥¸¡¼»ï¤Ï¡¢68,402¾ÉÎã¤Î½¸Àѥǡ¼¥¿¤ò¸¡Æ¤¤·¡¢¹ß°µºÞARB¤òÉþÍѤ·¤¿´µ¼Ô¤¬ÉþÍѤ·¤Ê¤¤´µ¼Ô¤ÈÈæ¤Ù¤Æ¿·¤¿¤Ê¤¬¤ó¤Î¥ê¥¹¥¯¤ò11%¡¢¿·¤¿¤ÊÇÙ¤¬¤ó¥ê¥¹¥¯¤ò25%Áý²Ã¤µ¤»¤ë¤³¤È¤ò¼¨¤·¤¿¡£1ǯ¸åÊƹñFDA¤È²¤½£°åÌôÉÊÄ£¤Ï¡¢ÌäÂê¤Ê¤¤¤È·ëÏÀ¤·¤¿¤¬¡¢Èà¤ÏǼÆÀ¤»¤º¡¢´µ¼Ô¥ì¥Ù¥ë¤Î¥Ç¡¼¥¿¤ËÅö¤¿¤ê¡¢ARB¤¬¤¬¤ó¤Î¥ê¥¹¥¯¤òÁýÂ礵¤»¤ë³Î¿®¤ò¿¼¤á¤¿¡£Èà¤Ï¡¢Êƹṉ̃¤ÎÌ¿¤Ë¤«¤«¤ï¤ë¤³¤È¤È¾å»Ê¤ËÁʤ¨¤¿¤¬¡¢¾å»Ê¤Ï¸½ºß¤½¤ÎÌäÂê¤Ë´Ø¤ï¤ì¤ë¿Í¼ê¤¬¤Ê¤¤¤ÈµñÈݤ·¤¿¡£

¡¡2010ǯ¤Ë¹Ô¤ï¤ì¤¿Èà¤Î°åÌôÉÊɾ²Á¤Ë¤è¤Ã¤Æ»ÈÍѤòÂ礭¤¯À©¸Â¤µ¤ì¤¿ÅüǢɼ£Îźޥ¢¥Ð¥ó¥Ç¥£¥¢(°ìÈÌ̾¥í¥·¥°¥ê¥¿¥¾¥ó)¡¢¤¬¤½¤ÎÀ©¸Â¤ò²ò¤«¤ì¤è¤¦¤È¤·¤Æ¤¤¤ë¡£

¡¡Èà¤Ï¡¢´ë¶È¤¬¤¹¤Ù¤Æ¤ÎÎ×¾²»î¸³¥Ç¡¼¥¿¤ò¥³¥ó¥È¥í¡¼¥ë¤·¤Æ¤¤¤ë¸½¾õ¤Ç¤Ï¡¢¥Ç¡¼¥¿¤¬Àµ³Î¤Ç´°Á´¤Ç¤¢¤ë¤«¤É¤¦¤«¤ò³Îǧ¤¹¤ë¤Î¤ÏÈó¾ï¤ËÆñ¤·¤¤¤È½Ò¤Ù¡¢¸¦µæ¼Ô¤¬Î×¾²»î¸³¤ÎÅŻҥǡ¼¥¿¤òµ¬À©Ä£¤È¥¹¥Ý¥ó¥µ¡¼¤ËƱ»þ¤ËÁ÷¤ë¤³¤È¤ä¥é¥ó¥À¥à²½¤ò¡¢´ë¶È¤Ç¤Ê¤¯µ¬À©Ä£¤Ç¹Ô¤¦¤³¤È¤Ê¤É¤òÄó¸À¤·¤Æ¤¤¤ë¡£

¢¨ ·ç¬ÃͤȤϡ¢µ­Ï¿¤µ¤ì¤ë¤Ù¤­¤Ç¤¢¤Ã¤¿¤¬¡¢²¿¤é¤«¤ÎÍýͳ¤Çµ­Ï¿¤µ¤ì¤Æ¤¤¤º¶õÇò¤È¤Ê¤Ã¤¿¥Ç¡¼¥¿¤ò¤¤¤¦¡£
-------------------------------------------------------------------------------------------------------

¡¡¥Þ¥ë¥Á¥Ë¥£¥¢¥¯»á¤Ï¡¢¡Ö´ë¶È¤¬¤¹¤Ù¤Æ¤ÎÎ×¾²»î¸³¥Ç¡¼¥¿¤ò¥³¥ó¥È¥í¡¼¥ë¤·¤Æ¤¤¤ë¸½¾õ¤Ç¤Ï¡¢¥Ç¡¼¥¿¤¬Àµ³Î¤Ç´°Á´¤Ç¤¢¤ë¤«¤É¤¦¤«¤ò³Îǧ¤¹¤ë¤Î¤ÏÈó¾ï¤ËÆñ¤·¤¤¡×¤È½Ò¤Ù¤Æ¤¤¤ë¡£²ò·è¤ÎÊý¸þ¤Ë¸þ¤«¤ï¤»¤ë¤Ë¤Ï¡¢¥³¥¯¥é¥ó¶¦Æ±·×²è¤äBMJ»ï¤¬µá¤á¤Æ¤¤¤ëÎ×¾²»î¸³ÅÐÏ¿¤ÎÅ°Äì¡¢Á´Î×¾²»î¸³¥Ç¡¼¥¿¤Î¸ø³«(¢¨1¡¢¢¨2)¤¬ÉԲķç¤Ç¤¢¤ë¡£
¡¡¤Þ¤¿Î㤨¤Ð¿·Ìô¾µÇ§¤Îº¬µò¤È¤Ê¤ëÂè­·ÁêÈæ³ÓÎ×¾²»î¸³¤Ï2¤Ä°Ê¾å¤¬É¬Íפǡ¢¤½¤ì¤é¤Î¤¦¤Á1¤Ä¤ÏÅö³ºÀ½Ìô´ë¶È¤È¤ÏÆÈΩ¤ÎÁÈ¿¥¤¬¼Â»Ü¤·¤¿¤â¤Î¤È¤¹¤ë(¢¨3)¤Ê¤É¤Î¼è¤êÁȤߤ¬É¬ÍפǤ¢¤ë¡£¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡¡(T)
-------------------------------------------------------------------------------------------------------