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Bioethics and Research Protections News March 2009

Part of Study Testing Trauma Treatments Is Shut Down. Rob Stein. The Washington Post. 2009-03-27.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/26/AR2009032603704.html

3 Researchers at Harvard Are Named in Subpoena. Gardiner Harris. The New York Times. 2009-03-27.
URL: http://www.nytimes.com/2009/03/28/health/policy/28subpoena.html (Requires free registration)

An Overseer of Trials in Medicine Draws Fire. Barry Meier. The New York Times. 2009-03-26.
URL: http://www.nytimes.com/2009/03/27/business/27clinic.html (Requires free registration)

Committee on Energy and Commerce, Subcommittee on Oversight and Investigation Hearing: Institutional Review Boards that Oversee Experimental Human Testing for Profit. 2009-03-26. (Includes links to testimony, exhibit binder, and videocast.) Accessed on 2009-03-27 at: http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1552&Itemid=95

Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation GAO-09-448T, March 26, 2009. Accessed on 2009-03-27 at: http://www.gao.gov/new.items/d09448t.pdf

Maryland Hause Institutional Review Board (IRB): http://marylandhauseirb.com/
Maryland Hause Institutional Review Board CEO Skipper Dawg (deceased): http://www.circare.org/images/skipper_dawg.jpg
Maryland Hause IRB HHS Office for Human Research Protections IRB registration: http://ohrp.cit.nih.gov/search/irbdtl.asp?IRBID=6374

Device Med-Systems: http://devicemedsystems.com/
Device Med-Systems HHS Office for Human Research Protections Federal Wide Assurance (FWA) Registration: http://ohrp.cit.nih.gov/search/asurdtl.asp?ASURID=15658

Additional Fictive Entity Registered with HHS-OHRP by GAO:
Phaké Med Devices, Inc. (Paynesville, SC): http://ohrp.cit.nih.gov/search/asurdtl.asp?ASURID=16653

FDA's HSP/BIMO Initiative Accomplishments — Update. 2009-03-25. Accessed on 2009-03-30 at: http://www.fda.gov/oc/gcp/hsp_bimo.html

More information about Coast Institutional Review Board: http://www.circare.org/info/coastirb.htm

Coast CEO is chided by congressional panel. Andrew Wineke. The Colorado Gazette. 2009-03-26.
URL: http://www.gazette.com/articles/coast_50672___article.html/dueber_review.html

Sting Operation Exposes Gaps in Oversight of Human Experiments. Alicia Mundy. The Wall Street Journal. 2009-03-26.
URL: http://online.wsj.com/article/SB123811179572353181.html

Investigators win approval of fake medical product. Jim Abrams. AP. 2009-03-26.
URL: http://www.google.com/hostednews/ap/article/ALeqM5jS05NrOriTuDXEIj3I4amzySYCIQD975T8K80

Trial safety lacking, says GAO. Alana Katsnelson. The Scientist. 2009-03-26.
URL: http://www.the-scientist.com/blog/display/55546/

UPDATE: Regulators Under Fire For Oversight Of Human Trials. Jared Favole. Dow Jones Newswire. 2009-03-26.
URL: http://online.wsj.com/article/BT-CO-20090326-711930.html

Was a Three-Legged Dog Head of a Review Board? Alicia Mundy. The Wall Street Journal Blog. 2009-03-26.
URL: http://blogs.wsj.com/health/2009/03/26/was-a-three-legged-dog-head-of-a-review-board/

Lawmakers Detail Medical Research Sting: Company Was a Real Dog. Alicia Mundy. The Wall Street Journal Blog. 2009-03-26.
URL: http://blogs.wsj.com/washwire/2009/03/26/lawmakers-detail-medical-research-sting-ceo-was-a-real-dog/

Coast IRB Tells Congressional Committee Sting Operation Was Illegal, Unnecessarily Harmful. Coast IRB Press Release. 2009-03-26.
URL: http://sev.prnewswire.com/health-care-hospitals/20090326/DA8940226032009-1.html

Porton Down 'Not a Death Sentence.' BBC News. 2009-03-25.
URL: http://news.bbc.co.uk/2/hi/health/7961034.stm

Safety of Drug Trials Tested. Barbara Basler. AARP Bulletin Today. 2009-03-19.
URL: http://bulletin.aarp.org/yourhealth/policy/articles/safety_of_drug_trials_tested.html

Once-secret drug-company records put U on the spot. Maura Lerner and Janet Moore. Minneapolis Star-Tribune. 2009-03-19.
URL: http://www.startribune.com/41470522.html

U doctor scrutinized over drug research. Jeremy Olson. The Pioneer Press. 2009-03-18.
URL: http://www.twincities.com/ci_11945154

A Silenced Drug Study Creates An Uproar. The Washington Post. Shankar Vedantam. 2009-03-18.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/17/AR2009031703786.html

Springs firm will testify to D.C. panel. Wayne Heilman. The Colorado Gazette. 2009-03-18.
URL: http://www.gazette.com/articles/coast_50194___article.html/company_dueber.html

Critics Object to 'Pseudoscience' Center. David Brown. The Washington Post. 2009-03-17.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/16/AR2009031602139.html

Medical clinical research slows for lack of patients. The Los Angeles Times. 2009-03-14.
URL: http://www.latimes.com/features/health/medicine/la-sci-clinical-trails14-2009mar14,0,6701970.story

Testing Firm Finds Itself Being Tested. Barry Meier. The New York Times. 2009-03-13.
URL: http://www.nytimes.com/2009/03/13/business/13sting.html (Requires free registration)

Clinical Trial Fraud Detected by Independent Review Board, part of a congressional sting operation. Coast IRB Press Releases. 2009-03-10 and 11: http://www.circare.org/info/coastirb_pressreleases_20090311.pdf Originally accessed on 2009-03-13 at: http://www.coastirb.com/press-releases

FDA Warning Letter to Coast Institutional Review Board. 2008-03-01: http://www.fda.gov/cder/warn/2008/08-HFD-45-1101.pdf

Hyperbaric Autism Treatment Shows Possible Promise. Joseph Brownstein. ABC News. 2009-03-13.
URL: http://i.abcnews.com/print?id=7070353

Google Co-Founder Backs Vast Parkinson's Study. Andrew Pollack. The New York Times. 2009-03-11.
URL: http://www.nytimes.com/2009/03/12/business/12gene.html (Requires free registration)

Painkiller Trial Raises Questions for FDA, Pfizer. Shannon Brownlee and Jeanne Lenzer. The Center for Public Integrity. 2009-03-11.
URL: http://www.publicintegrity.org/articles/entry/1203/

Ex-New York Health Commissioner Is F.D.A. Pick. Gardiner Harris. The New York Times. 2009-03-11.
URL: http://www.nytimes.com/2009/03/12/us/politics/12hamburg.html (Requires free registration)

Carl Elliott: Create counterweights to the influence of money on drug studies. Carl Elliot. St. Paul Pioneer Press. 2009-03-11.
URL: http://www.twincities.com/opinion/ci_11881144?nclick_check=1

Doctor Admits Pain Studies Were Frauds, Hospital Says. Gardiner Harris. The New York Times. 2009-03-10.
URL: http://www.nytimes.com/2009/03/11/health/research/11pain.html (Requires free registration)

Obama's Order on Stem Cells Leaves Key Questions to NIH. Rob Stein. The Washington Post. 2009-03-10.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/09/AR2009030903156.html

Obama Aims to Shield Science From Politics. Rob Stein. The Washington Post. 2009-03-09.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2009/03/08/AR2009030801476.html

Political Lobbying Drove FDA Process. Alicia Mundy. The Wall Street Journal. 2009-03-06.
URL: http://online.wsj.com/article/SB123629954783946701.html

Goode, John S. FDA Center for Devices and Radiological Health, 510k Memo re: ReGen Biologics Collagen Scaffold (CS). 2008-08-14: http://www.circare.org/foia5/goode_20080814.pdf (courtesy of The Wall Street Journal)

Senger, Jeffrey. FDA re: ReGen Biologics Collagen Scaffold (CS) 510k. 2008-11-03: http://www.circare.org/foia5/senger_20081103.pdf (courtesy of The Wall Street Journal)

FDA Warning Letter to ReGen Biologics, Franklin Lakes, NJ. 2005-09-15: http://www.fda.gov/foi/warning_letters/archive/g5481d.pdf

FDA Warning Letter to Vail Valley Medical Center Institutional Review Board, Vail, CO. 2006-06-22: http://www.fda.gov/foi/warning_letters/archive/g5903d.pdf

FDA Center for Devices and Radiological Health, Orthopedic and Rehabilitation Devices Panel, Meeting of 2008-11-14. Accessed on 2009-03-09 at: http://www.fda.gov/ohrms/dockets/ac/cdrh08.html#orthopaedic

Hines J, Lurie P. Testimony before FDA on Collagen Scaffold Medical Device. Public Citizen Health Research Group. Accessed on 2009-03-10 at: http://www.citizen.org/publications/release.cfm?ID=7620

Obama Reversing Stem Cell Limits Bush Imposed. David Stout and Gardiner Harris. The New York Times. 2009-03-06.
URL: http://www.nytimes.com/2009/03/07/us/politics/07stem.html (Requires free registration)

Med school pares rules on conflicts of interest. Janet Moore. Minneapolis Star-Tribune. 2009-03-03.
URL: http://www.startribune.com/business/40682112.html

South Florida doctors, hospitals named in fraud lawsuit. John Dorschner. The Miami Herald. 2009-03-02.
URL: http://www.miamiherald.com/business/v-print/story/925707.html

EXCLUSIVE: Sen. Hatch's secret drug firm links. Jim McElhatton. The Washington Times. 2009-03-02.
URL: http://washingtontimes.com/news/2009/mar/02/the-fog-of-congressional-transparency/

Harvard Medical School in Ethics Quandary. Duff Wilson. The New York Times. 2009-03-02.
URL: http://www.nytimes.com/2009/03/03/business/03medschool.html (Requires free registration)

What I Learned as a Subject. Robin Whitsell. Applied Clinical Trials. 2009-03-01.
URL: http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor/What-I-Learned-as-a-Subject/ArticleStandard/Article/detail/586868


Last Updated: 2009-12-03

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