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Bioethics and Research Protections News September and October 2009

Bending the Rules of Clinical Trials. Pauline W. Chen. The New York Times. 2009-10-29
URL: http://www.nytimes.com/2009/10/29/health/29chen.html

The Heart of the Matter How Congress and Special Interests Kept Crucial Clinical Trial Data Secret. Nancy Watzman. The Sunlight Foundation. 2009-10-28
URL: http://www.sunlightfoundation.com/projects/2009/heart_of_the_matter/

Stryker Biotech Indicted on Several Counts. Eric Convey. Boston Business Journal. 2009-10-28
URL: http://boston.bizjournals.com/boston/stories/2009/10/26/daily37.html

Stryker Biotech and Its Top Management Indicted for Illegal Promotion of Medical Devices Used In Invasive Surgeries. United States Department of Justice Press Release. 2009-10-28
URL: http://www.justice.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Oct2009/StrykerBiotechPR.html

Stryker Biotech, LLC, Mark Philip, William Heppner, David Ard, Jeffrey Whitaker. Criminal No. 09CR10330 USDC MA Indictment. 2009-10-28: Accessed on 2009-10-29 at: http://www.circare.org/lex/09cr10330_20091028.pdf

Anthrax Drug Stirs Concern. Jennifer Corbett Dooren. The Wall Street Journal. 2009-10-27
URL: http://online.wsj.com/article/SB10001424052748704335904574497533722151894.html

Briefing Materials for the October 27, 2009 Meeting of the Anti-Infective Drugs Advisory Committee. Accessed on 2009-10-23 at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm187299.htm#at

Industry Years Behind on Testing Approved Drugs. Gardiner Harris. The New York Times. 2009-10-26
URL: http://www.nytimes.com/2009/10/27/health/policy/27fda.html

Research Uproar at a Cancer Clinic. Duff Wilson. The New York Times. 2009-10-22
URL: http://www.nytimes.com/2009/10/23/business/23carle.html

Ten Years Later: Jesse Gelsinger's Death and Human Subjects Protection. Osagie Obasogie. The Hastings Center Bioethics Forum. 2009-10-22
URL: http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=4034

F.D.A. Lags in Banning Researchers After Fraud. Gardiner Harris. The New York Times. 2009-10-21
URL: http://www.nytimes.com/2009/10/22/health/policy/22fda.html

GAO-09-807 Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators. United States Government Accountability Office. 2009-10. Accessed on 2009-10-23 at: http://www.gao.gov/new.items/d09807.pdf

AIDS Vaccine Trial Shows Only Slight Protection. Donald G. McNeil Jr. The New York Times. 2009-10-20
URL: http://www.nytimes.com/2009/10/21/health/research/21vaccine.html

Editorial self-indulgence alert – Arthur Caplan is spot on. Bioethics Needs More Than Number Crunchers, says Caplan. Bioethics Blog. 2009-10-23
URL: http://blog.bioethics.net/2009/10/bioethics-needs-more-than-number-crunchers-says-ca/

Panel Finds Shortcomings in Bone Study. Barry Meier. The New York Times. 2009-10-15
URL: http://www.nytimes.com/2009/10/16/health/research/16doctor.html

Data Call Into Question HIV Study Results. Gautam Naik and Mark Schoofs. The Wall Street Journal. 2009-10-12
URL: http://online.wsj.com/article/SB125511780864976689.html

Orthopedists Fail to Disclose Payments. Keith J. Winstein. The Wall Street Journal. 2009-10-08
URL: http://online.wsj.com/article/SB10001424052748704252004574459423318094700.html

Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M. Accuracy of Conflict-of-Interest Disclosures Reported by Physicians. N Engl J Med 2009;361:1466-74. Accessed on 2009-10-12 at: http://content.nejm.org/cgi/reprint/361/15/1466.pdf

Government Orders Columbia to Tell Patients 'True Nature' of Drug Study. Jeanne Lenzer and Shannon Brownlee. Huffington Post. 2009-10-07
URL: http://www.huffingtonpost.com/2009/10/07/government-orders-columbi_n_312536.html

Doctor Is Pressed Again on Ties to Device Makers. Barry Meier. The New York Times. 2009-09-21
URL: http://www.nytimes.com/2009/09/22/health/22cardio.html

Seeking Justice For My Son. Paul Gelsinger. The Philadelphia Inquirer. 2009-09-17
URL: http://www.philly.com/inquirer/opinion/20090917_Seeking_justice_for_my_son.html

Awareness: Clinical Trial Rule Is Widely Ignored. Roni Caryn Rabin. The New York Times. 2009-09-04
URL: http://www.nytimes.com/2009/09/08/health/08aware.html (Requires free registration)

Pitt, Johns Hopkins scientist sued over prostate cancer research. Brian Bowling. Pittsburgh Tribune-Review. 2009-09-03
URL: http://www.pittsburghlive.com/x/pittsburghtrib/news/s_641304.html

Document Details Plan to Promote Costly Drug. Gardiner Harris. The New York Times. 2009-08-01
URL: http://www.nytimes.com/2009/09/02/business/02drug.html (Requires free registration)

Forest Laboratories. Lexapro Fiscal 2004 Marketing Plan: http://www.nytimes.com/packages/pdf/politics/20090831MEDICARE/20090831_MEDICARE.pdf (Courtesy of the New York Times)


Last Updated: 2010-01-22

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