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FDA
commissioner abruptly steps down, Seattle Times, Sept 24, 2005
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"Food
and Drug Administration (FDA) Commissioner Lester Crawford resigned unexpectedly yesterday, two months after he survived a tough Senate confirmation…"
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Parents
gamble on unproven therapy to give daughter a normal life, Myrtle Beach Sun News, Sept 23, 2005
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"Last
week, little Ariel Coover lay with her chin tucked to her chest in a bright, white operating room at Cooper University Hospital in Camden, N.J. The only visible part of the 3 1/2-month-old was the top of her bald head, where six catheters protruded like shiny strands of hair…Ariel is the latest and youngest patient in the first clinical gene-transfer study…"
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Possible
Conflicts for Doctors Are Seen on Medical Devices, Wilmington Morning Star, Sept 22, 2005 ()
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"…in
a variety of ways, many doctors have unusually close, if largely unseen, ties to device makers. And those relationships are a central issue on an emerging battleground in the health care wars: the upward cost spiral of implantable medical devices…"
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Senate
Eyes FDA Conflict of Interest Probe, The San Francisco Chronicle, Sept 21, 2005
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"Senators
asked Congress' investigative arm Wednesday to look into the Food and Drug Administration's practice of letting scientists serve on its advisory panels even if they have conflicts of interest…"
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U.S.
Senate votes for more information on FDA panels, Reuters, Sept 21, 2005 ()
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"The
Food and Drug Administration would have to disclose the industry ties of advisory committee members 15 days prior to their meetings under a measure passed by the U.S. Senate…"
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Drug
firms launch Web site to disclose trials data, Reuters, Sept 21, 2005 ()
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"The
global pharmaceutical industry launched a new Web site on Wednesday giving details of clinical trials on new medicines, in a bid to allay patient fears over drug safety…"
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International
Federation of Pharmaceutical Manufacturers and Associations Clinical Trials Portal ()
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Journal
of the American Medical Association Special Issue: Medical Research - State of the Science, JAMA 294, pp. 1307-E8, Sept 21, 2005 ()
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Selected
articles include:
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Financial
Anatomy of Biomedical Research, Moses et al. JAMA 294:1333-1342, Sept 21, 2005 ()
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US
Biomedical Research: Basic, Translational, and Clinical Sciences, Zerhouni, JAMA 294:1352-1358, Sept 21, 2005 ()
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Prospects
for the Future of Child Health Through Research, Feigin, JAMA 294:1373-1379, Sept 21, 2005 ()
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Public
Attitudes and Perceptions About Health-Related Research, Woolley and Propst, JAMA 294:1380-1384, Sept 21, 2005 ()
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Consensus
and Controversy in Clinical Research Ethics, Brody et al., JAMA 294:1411-1414, Sept 21, 2005
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Guidance
on Institutional Review Board (IRB) Review of Clinical Trial Websites, Office for Human Research Protections (OHRP) Web Site, Sept 20, 2005
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"The
guidance, which applies to HHS-conducted or -supported research, describes the circumstances for which IRB review of clinical trial websites is required and provides some points to consider in the review process. It also describes the circumstances for which IRB review of clinical trial websites is not required…"
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Requests
for Public Comment, OHRP Website, Sept 20, 2005
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"OHRP
has added a "Requests for Public Comment" section to its website. Simultaneously with the addition of the new website section, OHRP invites public comments on the following…"
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OHRP's August 31, 2005 Letter to the National Cancer Institute (NCI) on Conflicting Interest and the Pediatric Central IRB (PedCIRB) ()
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Study:
Medical Research Spending Jumps, The San Francisco Chronicle, Sept 20, 2005
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"Total
U.S. spending on medical research has doubled in the past decade to nearly $95 billion a year, though whether the money is being well spent needs much better scrutiny, a study has found…"
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Financial
Anatomy of Biomedical Research, Moses et al. JAMA 294:1333-1342, Sept 21, 2005 ()
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Journal
of the American Medical Association Special Issue: Medical Research - State of the Science, JAMA 294, pp. 1307-E8, Sept 21, 2005 ()
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Report:
Ethical Considerations for Research on Housing-Related Health Hazards Involving Children, Board on Children, Youth and Families (BCYF) of the National Research Council and the Institute of Medicine, Sept 19, 2005
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"In
the wake of the Maryland Court of Appeals ruling in the case of Grimes v. Kennedy Krieger Institute, the National Academies was asked to review the challenges and ethical issues in conducting housing-related health hazards research…"
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Executive
Summary ()
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