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Bioethics and Research Protections News February 2008

Doctors `Repeatedly or Deliberately' Break FDA Drug-Trial Rules. Justin Blum. 2008-02-29:
URL: http://www.bloomberg.com/apps/news?pid=20601109&sid=a3iFD.rCBpA8&refer=home

Andreason PJ. Office for Human Research Protections determination letter to Columbia University Medical School re: Gonzalez Protocol. 2008-02-25: http://www.hhs.gov/ohrp/detrm_letrs/YR08/feb08e.pdf

Green S. Nicholas Gonzalez Treatment for Cancer: Gland Extracts, Coffee Enemas, Vitamin Megadoses, and Diets. 2000-03-20. Accessed on 2008-03-20 at: http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/kg.html

Orthopedic-Device Makers Accused of Paying Doctors. Avram Goldstein. Bloomberg News. 2008-02-28.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2008/02/27/AR2008022703256.html (Requires free registration.)

Related: Surgeons for Sale: Conflicts and Consultant Payments in the Medical Device Industry. United States Senate Special Committee on Aging. 2008-02-27: http://aging.senate.gov/hearing_detail.cfm?id=293677&

Controversial Stem Cell Treatment Attracts Thousands. Stephanie Sy and Karson Yiu. ABC News. 2008-02-15.
URL: http://i.abcnews.com/print?id=3931445

Democrats threaten to hold Bush official in contempt over Sanofi drug probe. Associated Press. 2008-02-13.
URL: http://www.iht.com/articles/ap/2008/02/13/america/NA-GEN-US-Sanofi-Congress-Hearing.php

Related: Ketek Clinical Study Fraud: What Did Aventis Know? House Committee on Energy and Commerce Subcommittee on Oversight and Investigations. 2008-02-12 (link to archived webcast): http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.021208.Ketek.shtml

Additional information about Sanofi–Aventis, Ketek™ and protocol 3014 is available on the CIRCARE web site at: http://www.circare.org/foia5/ketek.htm

Bush Administration Doesn't Turn Over FDA Documents (Update 2). Justin Blum. Bloomberg News. 2008-02-12.
URL: http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aIaktc9FM7k8

US government investigator says company disregarded signs of fraud in antibiotic study. Associated Press. 2008-02-12.
URL: http://www.iht.com/articles/ap/2008/02/12/america/NA-GEN-US-Sanofi-Hearing.php

FDA Fails to Debar Convicts, Report Finds. 22 Corporate Crime Reporter 7, 2008-02-12.
URL: http://www.corporatecrimereporter.com/fda021208.htm

Related: FDA's Faulty Safeguards Against Corruption: Concerns Over Debarment Use and Authority. Minority Committee Staff Report. Committee on Energy and Commerce. U.S. House of Representatives. 110th Congress. February 2008. Accessed on 2008-02-12 at: http://republicans.energycommerce.house.gov/Media/File/News/2.11.08_Republican_Report_on_FDA_Debarment_Process.pdf

Deaths Partially Halt Diabetes Study. Lauran Neergaard and Randolph E. Schmid. Associated Press. 2008-02-06.
URL: http://apnews.myway.com/article/20080206/D8UL44QG0.html

Related:Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial Information Page. National Heart Lung and Blood Institute. Accessed on 2008-02-07 at: http://www.nhlbi.nih.gov/health/prof/heart/other/accord/index.htm

ACCORD Study Protocol. Version of May 11, 2005. Accessed on 2008-02-07 at: http://www.accordtrial.org/web/public/documents/Protocol%20All%20Chapters.pdf

Diabetes Study Partially Halted After Deaths. Gina Kolata. The New York Times. 2008-02-07: http://www.nytimes.com/2008/02/07/health/07diabetes.html (Requires free registration.)

When Drug Trials Go Wrong, Patients Have Little Recourse. Sarah Rubenstein. The Wall Street Journal. 2008-01-31.
URL: http://online.wsj.com/article/SB120173515260330205.html

Related: STEPS Trial – Spheramine Safety and Efficacy Study. Clinicaltrials.gov. Last updated on 2007-12-21: http://www.clinicaltrials.gov/ct2/show/NCT00206687

UCLA Consent Form: http://online.wsj.com/public/resources/documents/trial-uclacons-01312008.pdf

University of South Florida Consent Form: http://online.wsj.com/public/resources/documents/trial-infconsfla-01312008.pdf
Correction 2008-02-12: This consent form mis–identified the University of Florida as the study site. The University of Florida was not involved in the Spheramine trial. We regret the error.

Clinical Trial Agreement between the regents of the University of California and Berlex: http://online.wsj.com/public/resources/documents/trial-uclaberlex-01312008.pdf

Paying for Patients. Alla Katsnelson. The Scientist. 2008;22(2):38.
URL: http://www.the-scientist.com/article/display/54196/ (Requires free registration.)


Last Updated: 2009-03-13

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