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Bioethics and Research Protections News October, November, and December 2008

Testing Grounds. Kris Hundley. The St. Petersburg Times. 2008-12-14.
URL: http://www.tampabay.com/specials/2008/reports/india/

Myxo ring controversy spotlights regulatory gray area: When does a tweaked device constitute a new product? Shelley Wood. HeartWire. 2008-12-11: http://www.theheart.org/article/928673.do

Audit leads to enrollment halt in research at veterans hospital. Kyung M. Song. The Seattle Times. 2008-12-10.
URL: http://seattletimes.nwsource.com/html/localnews/2008488704_veteransresearch10m0.html

Pfizer's Nigerian Nightmare. Nicole Perlroth. Forbes. 2008-12-08.
URL: http://www.forbes.com/forbes/2008/1208/066.html

Mitka M. JAMA. Chelation Therapy Trials Halted. 2008;300(19):2236. Accessed on 2009-03-09 at: http://jama.ama-assn.org/cgi/content/full/300/19/2236

Drug Industry Vets Back Group Behind Controversial Obama Ad. Alicia Mundy. Wall Street Journal Health Blog. 2008-11-13
URL: http://blogs.wsj.com/health/2008/11/03/drug-industry-vets-back-group-with-controversial-obama-ad/

RPT-Pfizer keen to settle Nigeria drug trial lawsuits. Mike Oboh. Reuters. 2008-10-27
URL: http://www.reuters.com/article/rbssHealthcareNews/idUSLR43285320081027

Pfizer drug case set for November out-of-court deal:lawyers. AFP. 2008-10-27
URL: http://afp.google.com/article/ALeqM5gDWShc88BhB3lP5vCYQpIIh4u_HQ

Clinical research has opened up new vistas of employment. The Financial Express. 2008-10-27
URL: http://www.financialexpress.com/news/Clinical-research-has-opened-up-new-vistas-of-employment/378234/

State medication protocol researchers sought money from drug firms. Emily Ramshaw. The Dallas Morning News. 2008-10-26
URL: http://www.dallasnews.com/sharedcontent/dws/news/texassouthwest/stories/DN-cmap_26tex.ART.State.Edition1.4a88179.html

Quickly Vetted, Treatment Is Offered to Patients. Reed Abelson. The New York Times. 2008-10-26
URL: http://www.nytimes.com/2008/10/27/health/policy/27device.html (Requires free registration)

SELECT Participant Letter. National Cancer Institute. Undated
URL: http://www.cancer.gov/SELECT-participant-letter

Life in Rent-a-Lab. Bob Grant. The Scientist 2008;22(10):70
URL: http://www.the-scientist.com/article/display/55042/ (Requires free registration)

The DNA Age Taking a Peek at the Experts' Genetic Secrets. Amy Harmon. The New York Times. 2008-10-19
URL: http://www.nytimes.com/2008/10/20/us/20gene.html (Requires free registration)

Ex-Stryker sales rep. pleads guilty. Eric Convey. Boston Business Journal. 2008-11-19
URL: http://boston.bizjournals.com/boston/stories/2008/11/17/daily36.html

Former Medical Device Company Manager Pleads Guilty to Making a False Statement and Felony Misbranding. U.S. Department of Justice Press Release. 2008-11-18
URL: http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Nov2008/MartinDarnellPleaPR.html (Ed.: the false statement was a falsified IRB approval.)

Darnell Martin. Criminal No. 08CR10338, USDC, MA. (Criminal Information in U.S.A. v Darnell Martin.) Available from: http://www.circare.org/lex/08cr100338_20081107.pdf

Boivin, WS. FDA Warning Letter to Stryker Biotech. 2008-04-28: http://www.circare.org/fdawls2/strykerbiotech_20080428.pdf

FDA CDRH Humanitarian Device Exemption. H020008-OP-1 Putty. Stryker Biotech. 2004-04-07. Accessed on 2009-07-11 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H020008

FDA CDRH Humanitarian Device Exemption. H010002-OP-1 ™ Implant. Stryker Biotech. 2001-10-17. Accessed on 2009-07-11 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H010002

FDA CDRH General Information on Humanitarian Device Exemptions. Accessed on 2009-07-11 at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm

Depression expert at Emory pulls out of research projects. Gayle White and Craig Schneider. The Atlanta Journal-Constitution. 2008-10-14
URL: http://www.ajc.com/metro/content/metro/dekalb/stories/2008/10/14/nemeroff_emory_funds.html

Briefing: Anatomy of a stem cell controversy. Peter Aldhous. New Scientist. 2008-10-13
URL: http://www.newscientist.com/article/dn14922-briefing-anatomy-of-a-stem-cell-controversy.html

The Trial of Their Lives. Stephanie Desmon. The Baltimore Sun. 2008-10-12
URL: http://www.baltimoresun.com/news/health/bal-vaccine,0,2108606.storygallery

Experts Conclude Pfizer Manipulated Studies. Stephanie Saul. The New York Times. 2008-10-08
URL: http://www.nytimes.com/2008/10/08/health/research/08drug.html (Requires free registration)

Stem-cell researcher guilty of falsifying data. Peter Aldous and Eugene Samuel Reich. New Scientist. 2008-10-07
URL: http://www.newscientist.com/article/dn14886-stemcell-researcher-guilty-of-falsifying-data.html

Questions raised about Northwestern use of valve device; prominent surgeon denies wrongdoing. Shelley Wood. HeartWire. 2008-10-07: http://www.theheart.org/article/909595.do

Emory psychiatrist steps down. Bob Grant. The Scientist. 2008-10-06
URL: http://www.the-scientist.com/blog/display/55072/

The Effects Of Disclosing Financial Interests On Participation In Medical Research. Medical News Today. 2008-10-06
URL: http://www.medicalnewstoday.com/articles/124271.php

Donating embryos for research may be easier said than done. Shari Roan. Los Angeles Times. 2008-10-06
URL: http://www.latimes.com/features/health/medicine/la-he-embryosresearch6-2008oct06,0,1278683.story

Top Psychiatrist Didn't Report Drug Makers' Pay. Gardiner Harris. The New York Times. 2008-10-03
URL: http://www.nytimes.com/2008/10/04/health/policy/04drug.html (Requires free registration)

Largest study of US children to begin in January. Associated Press. 2008-10-03.
URL: http://apnews.myway.com/article/20081003/D93J681O0.html


Last Updated: 2009-07-12

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