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Bioethics and Research Protections News July 2007

Suspended Gene Therapy Test Had Drawn Early Questions. Rick Weiss. Washington Post. 2007-07-28.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2007/07/27/AR2007072702242.html (Requires free registration.)

Patient in Gene Therapy Study Dies. Rick Weiss. Washington Post. 2007-07-27.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2007/07/27/AR2007072700226.html (Requires free registration.)

Patient in Experimental Gene Therapy Study Dies, F.D.A. Says, Denise Grady and Andrew Pollack. The New York Times. 2007-07-27.
URL: http://www.nytimes.com/2007/07/27/health/27gene.html (Requires free registration.)

FDA Statement on Gene Therapy Clinical Trial. FDA Press Release. 2007-07-26. Accessed on 2007-07-27 at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01672.html

Related: Consent Form, TG 13G01 A Phase 1/2 Study of Repeat Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fe Fusion Gene, in Inflammatory Arthritis Subjects with and without Concurrent TNF-alpha Antagonists. Sponsor: Targeted Genetics Corporation. 2006-05-08: http://www.circare.org/consents/consentform_13G01_20060508.pdf

Study of Intra-Articular Delivery of tgAAC94 in Inflammatory Arthritis Subjects. ClinicalTrials.Gov Identifier: NCT00126724. Study ID Numbers: 13G01; NIH Protocol Number: 0504-705. Last updated: 2007-05-24. Accessed on 2007-07-27 at: http://www.clinicaltrials.gov/ct/show/NCT00126724?order=2

(MAC: must use Safari) Gene Transfer Protocol Report. Study Title: A Phase 1 Dose Escalation Study of Repeat Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis Subjects with and without Concurrent TNF-α Antagonists. Protocol Number: 0504-705 [Targeted Genetics Corporation, Protocol Number 13G01]. Status as of 2006-10-05: Active. Accessed on 2007-07-27 at: http://www.gemcris.od.nih.gov/Contents/GC_CLIN_TRIAL_RPT_VIEW.asp?WIN_TYPE=R&CTID=705

Protocol Number 0504-705 Scientific Abstract Link. Accessed on 2007-07-27 at: http://www.gemcris.od.nih.gov/Abstracts/705_s.pdf

Protocol Number 0504-705 Non-technical Abstract Link. Accessed on 2007-07-27 at: http://www.gemcris.od.nih.gov/Abstracts/705_nt.pdf

Gene Transfer Protocol Report. Study Title: A Phase I Dose Escalation Study of Intra-Articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis. Protocol Number: 0307-588 [Targeted Genetics Corporation, Protocol Number 13E04]. Status as of 2005-05-13: No longer active. Accessed on 2007-07-27 at: http://www.gemcris.od.nih.gov/Contents/GC_CLIN_TRIAL_RPT_VIEW.asp?WIN_TYPE=R&CTID=589

Protocol Number 0307-588 Scientific Abstract Link. Accessed on 2007-07-27 at: http://www.gemcris.od.nih.gov/Abstracts/588_s.pdf

Protocol Number 0307-588 Non-technical Abstract Link. Accessed on 2007-07-27 at: http://www.gemcris.od.nih.gov/Abstracts/588_nt.pdf

NIH Recombinant DNA Advisory Committee Public Review. 2003-09-17. Accessed on 2007-07-27 at: http://www4.od.nih.gov/oba/RAC/minutes/Sept_2003_Minutes.pdf

Genetic Modification Clinical Research Information System (GeMCRIS) Gene Transfer Protocol Advanced Search. Accessed on 2007-07-27 at: http://www.gemcris.od.nih.gov/Contents/GC_CT_RPT_MAKER.asp

Recombinant DNA Advisory Committee (RAC) Documents. Accessed on 2007-07-27 at: http://www4.od.nih.gov/oba/rac/documents1.htm

Recombinant DNA Advisory Committee (RAC) Protocol List. Accessed on 2007-07-27 at: http://www4.od.nih.gov/oba/rac/PROTOCOL.pdf

Targeted Genetics Provides Update on Inflammatory Arthritis Phase I/II Trial. Targeted Genetics Corporation Press Release. 2007-07-26. Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle&ID=1032343&highlight=

Targeted Genetics' Inflammatory Arthritis Phase I/II Trial Placed on Clinical Hold. Targeted Genetics Corporation Press Release. 2007-07-24. Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle&ID=1030172&highlight=

Targeted Genetics Amends tgAAC94 Clinical Protocol and Advances Ongoing Trial to Phase I/II; Amendment Potentially Accelerates Clinical Development Of Therapy. Targeted Genetics Corporation Press Release. 2006-03-16. Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle_print&ID=832420&highlight=

Encouraging Interim Results from a Phase I/II Trial of Targeted Genetics' tgAAC94 in Patients with Inflammatory Arthritis. Targeted Genetics Corporation Press Release. 2006-06-05. Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle_print&ID=871603&highlight=

Interim Data on Use of tgAAC94 in the Treatment of Inflammatory Arthritis Presented at the European Rheumatology Meeting (EULAR); Results provide preliminary evidence for sustained improvements in signs and symptoms of disease. Targeted Genetics Corporation Press Release. 2006-06-22. Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle_print&ID=875154&highlight=

Targeted Genetics Initiates Next Clinical Trial of tgAAC94 in Inflammatory Arthritis. Targeted Genetics Corporation Press Release. 2005-10-11. Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle&ID=766183&highlight=

Targeted Genetics Announces Preliminary Results of Phase I Clinical Trial of tgAAC94 in Patients With Inflammatory Arthritis. Targeted Genetics Corporation Press Release. 2005-07-26. Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle&ID=734830&highlight=

Targeted Genetics Receives Approval to Begin Clinical Trial of tgAAC94 in Rheumatoid Arthritis. Targeted Genetics Corporation Press Release. 2004-01-20. Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-newsArticle&ID=485993&highlight=

Targeted Genetics Corporation Press Release Index (2003-2007). Accessed on 2007-07-27 at: http://ir.targen.com/phoenix.zhtml?c=84981&p=irol-news&nyo=0

Targeted Genetics Corporation. Accessed on 2007-07-27 at: http://www.targen.com/fmdwebframework/publish/publish.aspx?Page=default&Template=HomePage

The Observer and autism: a clarification. The Observer. 2007-07-22.
URL: http://observer.guardian.co.uk/comment/story/0,,2131994,00.html

Misconduct hearing starts in Britain. Daniel Cressey. Nature. 2007-07-18.
URL: http://www.nature.com/news/2007/070716/full/070716-6.html

Doctor at centre of MMR controversy accused of paying children at party for blood samples. Sarah Boseley. The Guardian. 2007-07-17.
URL: http://www.guardian.co.uk/frontpage/story/0,,2128151,00.html

MMR scare doctor 'paid children'. BBC News. 2007-07-16.
URL: http://news.bbc.co.uk/2/hi/health/6289166.stm

MMR doctor on misconduct charges. BBC News. 2007-07-16.
URL: http://news.bbc.co.uk/2/hi/uk_news/6900974.stm

Public health experts fear fallout from MMR hearing. Sarah Boseley. The Guardian. 2007-07-14.
URL: http://society.guardian.co.uk/health/story/0,,2126188,00.html

Autism: the truth. Anjana Ahuja. The Times. 2007-07-12.
URL: http://www.timesonline.co.uk/tol/life_and_style/health/article2060575.ece

Baby deaths doctor cleared. BBC News. 2007-07-11.
URL: http://news.bbc.co.uk/2/hi/uk_news/scotland/north_east/6291224.stm

Surgeon General Sees 4-Year Term as Compromised. Gardiner Harris. The New York Times. 2007-07-11.
URL: http://www.nytimes.com/2007/07/11/washington/11surgeon.html?_r=1&ref=health&oref=slogin (Requires free registration.)

Ex-director of UCLA cadaver program gets plea deal. Stuart Silverstein. Los Angeles Times. 2007-07-11.
URL: http://www.latimes.com/features/health/medicine/la-me-body11jul11,1,2930955.story?coll=la-health-medicine (Requires free registration.)

Parents of autistic boy who died sue local doctor. Associated Press / Pittsburgh Tribune-Review. 2007-07-09.
URL: http://www.pittsburghlive.com/x/pittsburghtrib/news/breaking/s_516428.html

Companies run trials of drugs they invest in. Kris Hundley. St. Petersburgh Times. 2007-07-01.
URL: http://www.sptimes.com/2007/07/01/Worldandnation/Companies_run_trials_.shtml

The MMR-autism theory? There's nothing in it. Michael Fitzpatrick. Spiked Online. 2007-07-04.
URL: http://www.spiked-online.com/index.php?/site/article/3562/

Fitness to Practise Panels week commencing 09 July 2007. Dr Andrew Wakefield, Professor John Walker-Smith, Professor Simon Murch. General Medical Council Press Release. 2007-07-02. Accessed on 2007-07-08 at: http://www.gmcpressoffice.org.uk/apps/news/latest/detail.php?key=345

Andrew Wakefield, John Walker-Smith, Simon Murch. General Medical Council Fitness to Practice Panel, Charge Sheet. 2007-07-16: http://www.circare.org/consents/wakefield_20070716.pdf


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Last Updated: 2007-09-13

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