i9a propssed tie from the FoodandDrugAdministration (FDA)wouIdprovidepublic access mostof thestudydesign to andsafety informationon all new or ongoingcJ&ical triaIsinvolving eithergenetherapyor xenotransplantation. TheFDAwould not release confidential business information or personal informationrelatedto studyparticipants. In humangene therapy, the biological properties living of ceIIs altered therapeutic are for use.XenotranspIantationthe is transferof organs from ananimal to a human, Muchof theinformationthat would bedisclosed aboutgene therapytrialsunderthisproposal is already publiclydiscussed in openmeetings theRecombiof
nantDNAAdvisory Committee theNational of Institutes Health.Simiof larly,informationabout xenotransplantation trials will alsobepublicly throughthe 181 avaiIabIe ,” Secretary’s - member AdvisoryCommittee on Jenotrans-plantation, on whichAPI Executive DirectorAIan Bergerrepresents the animaladvocacy movement. “Thepublicmust know what’sgoingon in theforefrontof medicine,” said Alan.“Genetherapyand xenotrq-plants arepotentially dangerous that canthreaten areas usall.” is You can help. There a 90daypubliccomment periodon the proposal. In your comments, by due 18,2001, point out that: s proposal bringsgene only therapyandxenotransplantation in compliance the with same typesof information already released thepublic to by othergovernment agencies. Because gravepublichealth of risks,disclosure shouldinclude additional information suchas physicians, medicalcenters, and soon -make publicall informationexcept tradesecrets andpatientidentification.
e FDAmustassume sole the esponsibility summarizing for anddistributinginformation submitte#d the-research by ‘5 2 &&or, &her@& g&e i? thesponsor’s discretion. :J3ecause thepublichealth of s6yrisks, issues, ethical cost uncertainty, theinabilit and other adequately assess
+., sz..“. Ii Youmustsendyour originalletter .-_ andthree-co@% FDA. tothe .,Cont;& ..-FH U.S.FoodandDrugAdministration;Dockets Management Branch; Fishers 5630 Lane;Room 1061; HFA-305; Rockville, MD 20852; 301-827-6870; fax email “fdadockets@oc.fda.gov”.
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