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Research Protections and Bioethics News April — June, 2003

NB: not all articles will remain available on the internet.

House Energy and Commerce Committee Launches Investigation Into Alleged Ethics Violations by Several NIH Officials. Kaiser Daily Health Policy Report. 2003-06-27.
URL: http://www.kaisernetwork.org/daily_reports/print_report.cfm?DR_ID=18524&dr_cat=3

NIH Officials Investigated for Possible Ethics Breach. Rick Weiss. The Washington Post. 2003-06-27.
URL: http://www. washingtonpost.com/wp-dyn/articles/A37557-2003Jun26.html

Former Cancer Institute Official is a Focus of Ethics Investigation. Aaron Zitner. The Los Angeles Times. 2003-06-27.
URL: http://www.latimes.com/templates/misc/printstory.jsp?slug=la-na-ethics27jun27&section=/printstory

Studies of Dietary Supplements Come Under Growing Scrutiny. Ford Fessenden. The New York Times. 2003-06-23.
URL: http:// www.nytimes.com/2003/06/23/national/23DIET.html?pagewanted=print&position=

Related:   Greenwich Diet Doctor Accused of Fraud – Clinical Studies Alleged to Have Been Falsified. NBC News / New Haven/Hartford CT Affiliate. 2003-06-09.
URL: http://www.nbc30.com/health/2257070/detail. html

San Diego judge rules NJ firm's ads, claims were misleading. Associated Press. 2003-05-30.
URL: http:// www.signonsandiego.com/news/business/20030530-1811-ca-cytodynelawsuit.html

FDA Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra. FDA Fact Sheet. 2003-02-28.
URL: http://www.fda.gov/bbs/topics/ NEWS/ephedra/factsheet.html

Energy and Commerce Leaders Initiate Examination of Ephedra. News Release. House Committee on Energy and Commerce. 2003-02-28.
URL: http://energycommerce.house.gov/ 108/News/02282003_807.htm

Bechler's diet pills draw scrutiny. Amy Shipley. The Washington Post. 2003-03-19.
URL: http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A27426-2003Feb18&notFound=true

New Stem Cell Surgery on Hold. Mike Martindale. The Detroit News. 2003-06-13.
URL: http://www.detnews.com/2003/ health/0306/13/d01-192073.htm

Ill-fated clinical trial never had federal OK Boy, 4, died at CHEO but hospital says it wasn't responsible for getting approvals. Mohammed Adam. The Ottawa Citizen. 2003-06-13.
URL: http://www. canada.com/search/story.aspx?id=8d9fa822-e640-443c-bb0d-d12a1f08f69c

Related:   Deadly Clinical trial wasn't approved by Health Canada. CBC Ottawa. 2003-06-12.
URL: http://www.cbc.ca/ottawa/story/ot_lucio20030612.html

Drug error kills child with cancer. CBC News. 2002-10-08.
URL: http://www.cbc.ca/ottawa/story/cheo021008.html

Health Canada 2002 Chronology / Chimeric Antibody Trial. (ATIP request by The Canadian Broadcasting Company.) Available from http://web.archive.org/web/20040612135616/http://www.ottawa.cbc.ca/ottawanews/newsdocs/chronology.pdf

Talking notes prepared for Health Minister Ann Mclellan. (ATIP request by The Canadian Broadcasting Company.) Available from http://www.ottawa.cbc.ca/ ottawanews/newsdocs/talkingnotes.pdf

Masiello SA. FDA Warning Letter to Jacqueline M. Halton M.D. 2003-04-04. Available from http://www.fda.gov/foi/warning_letters/ g3946d.pdf

Phase III Randomized Study of Adjuvant Isotretinoin With or Without Monoclonal Antibody Ch14.18, Interleukin-2, and Sargramostim (GM-CSF) in Patients With High-Risk Neuroblastoma Who Have Completed Myeloablative Therapy and Autologous Stem Cell Transplantation — Temporarily Closed. National Cancer Institute. 2003-04-30. Available from http://www.nci.nih.gov/clinicaltrials/view_clinicaltrials. aspx?version=healthprofessional&cdrid=69018&protocolsearchid=432979

Masiello SA. FDA Warning Letter to Alice Yu M.D., Ph.D. 2002-04-17. Available from http://www.fda.gov/foi/warning_letters/ g3181d.pdf

Masiello SA. FDA Warning Letter to Titan Pharmaceuticals. 2002-04-15. Available from http://www.fda.gov/foi/warning_letters/ g3180d.pdf

Guilty plea in medical fraud — 12 patients die Bay Area branch of Guidant fined $92 million over malfunctions. Stacy Finz. The San Fransciso Chronicle. 2003-06-13.
URL: http://www. sfgate.com/cgi-bin/article.cgi?file=/c/a/2003/06/13/MN200083.DTL

Health Canada is advising Canadians not to use Empowerplus. Health Canada — Warnings/Advisories. 2003-06-06.
URL: http://www.hc-sc.gc.ca/ english/protection/warnings/2003/2003_41.htm

Related:   Questions and Answers — Health Canada's Actions Against Empowerplus.
URL: http://www.hc-sc.gc .ca/english/protection/warnings/2003/empowerplus.htm

Concerns Regarding Nutritional Cure and Psychiatric Research. CIRCARE InfoMail. 2002-06-27.
URL: http://www.circare.org/im27June2002.htm

Borror KC. Office for Human Research Protections Determination Letter Issued to the University of Utah. 2002-08-19. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR02/aug02e.pdf

Assessing the Risks, Benefits of Clinical Trials. Beth Baker. AARP Bulletin Online. June, 2003.
URL: http://www.aarp.org /bulletin/departments/2003/health/0605_health_1.html

Related:   8 Questions to Ask Before You Sign Up for a Clinical Trial. AARP. Available from http://www.aarp.org/bulletin/departments/2003/health/0605_sidebar_2.html

Ernst E, Canter PH. Investigator bias and false positive findings in medical research. Trends in Pharmacological Sciences. 2003;24:219-221. Available from http://reviews.bmn.com/journals/atoz/latest?uid=TIPS.bmn06580_01656147_v0024i05_03000750

GMC reprimands doctor for research fraud. Owen Dyer. British Medical Journal. 2003;326:730.
URL: http://bmj.com/cgi/content/full/326 /7392/730/

Suffer the little children in the search for cures. Dan Vergano. USA Today. 2003-05-29.
URL: http://www.usatoday .com/tech/news/techpolicy/2003-05-28-kids-usat_x.htm

FDA Warning Letter Hints at Crackdown on Unregulated Research, IND Enforcement. M. Alexander Otto. Medical Research Law & Policy Report / BNA. 2003-05-07. Available from http://www.circare.org/bna05072003.pdf

Related:   JHU Researcher found to have violated rules. FDA proposes restrictions; study resulted in death. Julie Bell. The Baltimore Sun. 2003-04-18.
URL: http://www.sunspot.net/news/ local/bal-md.hopkins18apr18.story

FDA Warning Letter to Alkis Togias M.D. / Johns Hopkins Asthma and Allergy Center. 2003-03-31. Available from http://www.fda.gov/cder/warn/2003/02- hfd-45-0303.pdf

Form FDA 483 Notice of Inspectional Observations, Issued to Alkis Togias M.D. / Johns Hopkins Asthma and Allergy Center. 2001-06-28. Available from http://www.fda.gov/ora/frequent/ 483s/JohnHopkins483.html

Restart of drug-testing study rejected. Andy Dworkin. The Oregonian. 2003-04-30.
URL: http://www.oregonlive.com/science/oregonian/index.ssf?/base/science/1051705758159390.xml

Related:   Borror KC. OHRP Determination Letter to Oregon Health and Science University. 2003-04-17. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR03/apr03c.pdf

Borror KC. OHRP Determination Letter to Oregon Health and Science University. 2002-12-10. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR02/dec02f.pdf

Borror KC. OHRP Determination Letter to Oregon Health and Science University. 2002-10-24. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR02/oct02d.pdf

Borror KC. OHRP Determination Letter to Oregon Health and Science University. 2002-10-04. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR02/oct02a.pdf

Board rebukes AIDS evaluator — Doctor had helped Heimlich associate. Robert Anglen. The Cincinnati Enquirer. 2003-04-18.
URL: http://www.enquirer.com/ editions/2003/04/18/loc_heimlich18.html

Related:   Heimlich maneuvers in AIDS Therapy. Rueters. 2003-04-14.
URL: http:// www.cnn.com/2003/HEALTH/conditions/04/14/health.aids.malaria.reut/index.html

Researcher Violated Rules, says UCLA. Rebecca Trounson and Charles Ornstein. The Los Angeles Times. 2003-04-16.
URL: http://www.latimes.com/la-me- malaria16apr16,0,650344.story

Therapy's value challenged Medical community split on controversial AIDS treatment. Jeyling Chou. The Daily Bruin. 2003-02-23.
URL:http://www.dailybruin.ucla.edu/ news/articles.asp?id=23065

Scientists linked to Heimlich investigated – Experiment infects AIDS patients in China with malaria. Robert Anglen. The Cincinnati Enquirer. 2003-02-16.
URL: http://enquirer.com/editions/ 2003/02/16/loc_heimlich16.html

Researchers' possible link to malariotherapy scrutinized. Edward Chiao and Jeyling Chou. The Daily Bruin Online. 2002-11-22.
URL: http://www.dailybruin.ucla.edu/news/printable.asp?id=21891&date=11/22/2002

A Matter of Trust. CBC News. 2003-04-01.
URL: http://www.cbc.ca/consumers/indepth/ medical/index.html

Disclosures for cancer research — Scientists must reveal financial ties. Bernadette Tansey. The San Francisco Chronicle. 2003-04-30.
URL: http://www.sfgate. com/cgi-bin/article.cgi?f=/c/a/2003/04/30/BU176961.DTL

American Society of Clinical Oncology Policy Statement: Oversight of Clinical Research. Journal of Clinical Oncology. 2003;21(12). Available from http://www.jco.org/cgi/reprint/JCO. 2003.04.026v1.pdf

American Society of Clinical Oncology: Background for Update of Conflict of Interest Policy. Journal of Clinical Oncology. 2003;21(12). Available from http://www.jco.org/cgi/reprint/JCO. 2003.04.025v1.pdf

American Society of Clinical Oncology: Revised Conflict of Interest Policy. Journal of Clinical Oncology. 2003;21(12). Available from http://www.jco.org/cgi/reprint/JCO. 2003.04.524v1.pdf

American Society of Clinical Oncology Policy Statement Update: Genetic Testing for Cancer Susceptibility. Journal of Clinical Oncology. 2003;21(12). Available from http://www.jco.org/cgi/reprint/JCO. 2003.03.189v1.pdf


Last Updated: 2006-07-17

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