Text ::   Skip Nav ::

circare logo

Brochure Contact Home Privacy Site Map Terms of Use Tools Prev Next

print Print Page ::   Link to CIRCARE Link To ::

Research Protections and Bioethics News September, 2005

NB: Not all articles remain available on the internet.

Implant Program for Heart Device Was a Sales Spur. Barry Meier. The New York Times. 2005-09-27.
URL: http://www.nytimes.com/2005/09/27/business/27heart.html?pagewanted=all (Requires free registration.)

Address by COSATU secretary-general, Zwelinzima Vavi, to Treatment Action Campagin Congress. E-Health Capetown, SA. 2005-09-25.
URL: http://allafrica.com/stories/200509270349.html

MMR scare doctor faces list of charges. Brian Deer. UK Times Online. 2005-09-11.
URL: http://www.timesonline.co.uk/article/0,,2087-1774388,00.html

Bush's Choice for F.D.A. Chief to Keep Other Job. Robert Pear and Andrew Pollack. The New York Times. 2005-09-25.
URL: http://www.nytimes.com/2005/09/25/politics/25fda.html (Requires free registration.)

Leader of the F.D.A. Steps Down After a Short, Turbulent Tenure. Robert Pear and Andrew Pollack. The New York Times. 2005-09-24.
URL: http://www.nytimes.com/2005/09/24/politics/24fda.html?pagewanted=all (Requires free registration.)

A Mother's Denial, a Daughter's Death. Charles Ornstein and Daniel Costello. The Los Angeles Times. 2005-09-24.
URL: http://www.latimes.com/news/printedition/la-me-eliza24sep24,0,1237495,full.story (Requires free registration.)

Genentech Stops Enrolling Patients in Cancer Drug Trial. Bloomberg News (The New York Times). 2005-09-24.
URL: http://www.nytimes.com/2005/09/24/business/24drug.html (Requires free registration.)

Panel Investigates Whether Guidant Violated Agreement. Barry Meier. The New York Times. 2005-09-23.
URL: http://www.nytimes.com/2005/09/23/business/23guidant.html (Requires free registration.)

Related:   FDA 483 Inspectional Observations (08/22/2005 – 09/01/2005). Guidant Corporation, Saint Paul, MN. 2005-09-22. Available from http://www.fda.gov/ora/frequent/483s/2124215_guidant/guidant_rptFDA483_cfm1.html

Possible Conflicts for Doctors Are Seen on Medical Devices. Reed Abelson. The New York Times. 2005-09-22.
URL: http://www.nytimes.com/2005/09/22/business/22devices.html (Requires free registration)

Protect children more in research, panel says. Julie Bell. The Baltimore Sun. 2005-09-20.
URL: http://www.baltimoresun.com/news/local/bal-md.housing20sep20,1,7153896.story (Requires free registration.)

Related:   Environmental Protection Agency Supplementary Information and Request for Public Comments on 40 CFR 26 Protections for Subjects in Human Research Proposed Rule. Available from http://www.epa.gov/oppfead1/guidance/human-test.htm

40 CFR 26 Protections for Subjects in Human Research Proposed Rule. Environmental Protection Agency. 70 FR 175 (2005-09-12) pp. 53838-53866. Available from http://www.regulations.gov/fredpdfs/05-18010.pdf

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Institute of Medicine / National Academies of Science. 2005. Available from http://www.nap.edu/books/0309097266/html. Accessibility verified on 2005-09-21.

Officials Say Medicare Official Reassigned. Kevin Freking. AP/Las Vegas Sun. 2005-09-20.
URL: http://www.lasvegassun.com/sunbin/stories/text/2005/sep/20/092006596.html

Study: Medical Research Spending Jumps. Karla K. Johnson. AP Chicago. 2005-09-20.
URL: http://apnews.myway.com/article/20050920/D8CNVJO00.html

Medical trial oversight in poor shape. Julie Bell. The Baltimore Sun. 2005-09-18.
URL: http://www.baltimoresun.com/news/health/bal-pe.trials18sep18,1,2884869.story?coll=bal-health-headlines&ctrack=1&cset=true (Requires free registration.)

Related:   Secretary's Advisory Committee on Human Research Protections (SACHRP) / Meeting of 2005-08-01 and 02. Available from http://www.hhs.gov/ohrp/sachrp/mtgings/mtg08-05/mtg08-05.htm

SACHRP Meeting of 2005-08-01 and 02 / Agenda. Available from http://www.hhs.gov/ohrp/sachrp/mtgings/mtg08-05/meetingagenda.pdf

SACHRP Meeting of 2005-08-01 and 02 / Presentation Materials. Available from http://www.hhs.gov/ohrp/sachrp/mtgings/mtg08-05/present.htm

Gelsinger P. CIRCARE Presentation to the Secretary's Advisory Committee on Human Research Protections (SACHRP). 2005-08-02. Available from http://www.circare.org/submit/sachrp_20050802.pdf

FDA: Defibrillator Defects on the Rise. Lauran Neergard. Associated Press. 2005-09-17.
URL: http://apnews.myway.com/article/20050917/D8CLV9S00.html

Related:   Remarks by Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs. Speech before the Joint Meeting of the FDA and the Heart Rhythm Society, Washington, DC. 2005-09-16. Available from http://www.fda.gov/oc/speeches/2005/heart0916.html

Information from the September 16, 2005 Policy Conference on Pacemaker and ICD Performance Presented by the Heart Rhythm Society in Cooperation with the U.S. Food and Drug Administration. Available from http://www.fda.gov/cdrh/ocd/icd/

FDA Documents:   Pacemaker and ICD Generator Malfunctions: Rates, Trends, and Implications — Questions and Answers. 2005-09-16. Available from http://www.fda.gov/cdrh/ocd/icd/qa.html

Maisel WH, Moynahan M, Zuckerman BD, Gross TP, Tovar-Calderon OH, Tillman D-B, Schultz DB. Pacemaker and ICD Generator Malfunctions. 2005-09-26. Available from http://www.fda.gov/cdrh/ocd/icd/abstract.html

Presentations:   Moynahan M. Risk-Benefit Communication: FDA Viewpoint. 2005-09-16. Available from http://www.fda.gov/cdrh/ocd/icd/presentations/091605-moynahan.html

Gross TP. Approaches to Postmarket Device Evaluation: The FDA Perspective. 2005-09-16. Available from http://www.fda.gov/cdrh/ocd/icd/presentations/091605-gross.html

Ulatowski T. Post Market Analysis and Reporting, FDA Perspective. 2005-09-16. Available from http://www.fda.gov/cdrh/ocd/icd/presentations/091605-ulatowski.html

Available from What Patients Need and Want to Know from their Physicians, FDA Perspective. David Lewis M.D. (2005-09-16).

Migette W. (Heart Rhythm Society.) A Perspective On Medical Device Risk Management. 2005-09-16. Available from http://www.fda.gov/cdrh/ocd/icd/presentations/091605-midgette.html

Maisel WH. Pacemaker and ICD Generator Malfunctions. 2005-09-16. Available from http://www.fda.gov/cdrh/ocd/icd/presentations/091605-maisel.html

See also CIRCARE's concerns about Medicare policy and coverage for research particpation including updated coverage policy for ICDs for secondary prevention, and the new (draft) policy titled Coverage with Evidence Development describing compulsory research participation in return for coverage under certain conditions.

CIRCARE InfoMail about ICDs and Medicare draft guidance on Coverage with Evidence Development. 2005-05-25. Available from http://www.circare.org/im/im25May2005.htm

Maker of Heart Devices May Expand Release of Malfunction Data Beyond F.D.A. Barry Meier. The New York Times. 2005-09-17.
URL: http://www.nytimes.com/2005/09/17/politics/17device.html (Requires free registration.)

Abbott Gets F.D.A. Approval for Neck Stent With a Filter. Barnaby J. Feder. The New York Times. 2005-09-16.
URL: http://www.nytimes.com/2005/09/16/business/16neck.html (Requires free registration.)

F.D.A. Data on Defibrillators Expected. Barry Meier. The New York Times. 2005-09-16.
URL: http://www.nytimes.com/2005/09/16/business/16drug.html (Requires free registration.)

Lawmakers Push for More Data on Heart Devices. Barry Meier. The New York Times. 2005-09-15.
URL: http://www.nytimes.com/2005/09/15/business/15device.html (Requires free registration.)

Scientists plan real-life face off. Marilynn Marchione. Globe and Mail. 2005-09-14.
URL: http://www.theglobeandmail.com/servlet/story/RTGAM.20050914.wface0914/BNStory/specialScienceandHealth/

Cure Interrupted. Lesley Stahl. 60 Minutes. 2005-09-14.
URL: http://www.cbsnews.com/stories/2005/09/08/60minutes/main828098.shtml

Over Our Heads The bioethics council gets a lesson in limits. William Saletan. Slate. 2005-09-13.
URL: http://www.slate.com/id/2125933/?nav=navoa

F.D.A. Had Report of Short Circuit in Heart Devices. Barry Meier. The New York Times. 2005-09-12.
URL: http://www.nytimes.com/2005/09/12/business/12fda.html?pagewanted=all (Requires free registration.)

Bioethics Council Head to Step Down. Rick Weiss. The Washington Post. 2005-09-09.
URL: http://www.washingtonpost.com/wp-dyn/content/article/2005/09/08/AR2005090801921.html (Requires free registration.)

The Law of Unintended Consequences. Clifton Leaf. Fortune. 2005-09-07.
URL: http://www.fortune.com/fortune/print/0,15935,1101810,00.html

University Suspends 25–Year Smoking Study. AP News. 2005-09-02.
URL: http://apnews.myway.com/article/20050902/D8CC9FC00.html

Related: Indiana University Smoking Survey Study web site: http://www.indiana.edu/~smokesvy/

Prescription for Injustice. Florence A. Ruderman. The New York Times. 2005-09-01.
URL: http://www.nytimes.com/2005/09/01/opinion/01ruderman.html (Requires free registration.)

What have guinea pigs ever done for us? Vivienne Parry. UK Guardian. 2005-09-01.
URL: http://society.guardian.co.uk/health/story/0,7890,1559987,00.html

Parents of children with autism discuss results of chelation. Virginia Linn. Pittsburgh Post-Gazette. 2005-08-29.
URL: http://www.post-gazette.com/pg/05241/561879.stm

Spinal Cement Draws Patients and Questions. Gina Kolata. The New York Times. 2005-08-28.
URL: http://www.nytimes.com/2005/08/28/health/28spine.html?pagewanted=all (Requires free registration.)


Last Updated: 2006-07-17

If you find the information on this page helpful please support CIRCARE with a tax-deductible contribution today. Because CIRCARE doesn't accept funds from pharmaceutical or medical device manufacturers, we depend on contributions from individuals like you to help us advocate for meaningful protection of human subjects in research. Donating on-line with PayPal is quick and easy. Find out more on our Support page.

All material on this site © CIRCARE Incorporated (2002-2005) or as indicated. Single copies can be downloaded for personal education.   Adobe® Reader ::   ::

Valid HTML 4.01! Valid CSS!