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The American Journal of Medicine
Volume 122, Issue 4
, Pages 315-316
, April 2009
Doing More Good than Harm: Need for a Cease Fire
References
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- Rosiglitazone evaluated for cardiovascular outcomes—an interim analysis. N Engl J Med. 2007;357:28–38
- . The conscientious judgement of a DSMB—statistical stopping rules re-examined. Eur J Clin Pharmacol. 2008;64:69–72
Funding: See last page of article.
Conflict of Interest: None.
Authorship: The authors declare that each of them has participated in the drafting (CHH) and revision (CHH, DD, NBM, SB, JB) of the manuscript and that we have seen and approved the final version.
Funding: The financial affiliations with all organizations, including any with a financial interest, direct or indirect, in the subject matter or materials discussed in the article that may affect the conduct or reporting of the work submitted are listed below.Dr. Hennekens is funded by the Charles E. Schmidt College of Biomedical Science, Department of Clinical Science and Medical Education & Center of Excellence at Florida Atlantic University (FAU) as Principal Investigator (PI) on 2 investigator initiated research grants funded to FAU by Bayer. He serves as an independent scientist in an advisory role to investigators and sponsors, including as Chair or Member on Data and Safety Monitoring Boards (DSMBs), for Actelion, Amgen, AstraZeneca, Bristol-Myers Squibb, Food and Drug Administration (FDA), Hughes Hubbard & Reed LLP, National Association for Continuing Education, National Institutes of Health (NIH), Pfizer, PriMed, Sidley Austin LLP, and UpToDate. He serves on speakers' bureaus for the International Atherosclerosis Society and AstraZeneca, concerning lipids and heart failure, as well as Pfizer, concerning lipids. He receives royalties for authorship or editorship of 3 textbooks. He receives royalties as coinventor on patents concerning inflammatory markers and cardiovascular disease, which are held by Brigham and Women's Hospital. He has an investment management relationship with SunTrust Bank, who has sole discretionary investment authority.Dr. DeMets is supported 40% for teaching and administrative duties as Chair. 15% from an NIH grant to the University of Wisconsin-Madison (UW-M). 45% as PI on UW-M contracts with industry as an independent statistical data analysis center. Current sponsors are Astra-Zeneca, Amgen and Bristol-Myers Squib. He receives royalties as author or editor of 3 textbooks and has Tax Sheltered Accounts which are retirement accounts in mutual funds with Fidelity and UBS. He holds small amounts of stocks with Sun and Intell. He serves as consultant to NIH, FDA and the pharmaceutical or device industry. He serves as an independent biostatistician in an advisory role to investigators and sponsors as a member of DSMBs for Actelion, Amgen, Astra-Zeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CVRx, Genentech, Glaxo-Smith-Kline, Novartis, Otsuka, Pfizer, Roche, Sanofi-Aventis, Takeda, as well as Duke, Harvard and Hamilton Clinical Research Institutes.Dr. Bairey-Merz is funded by Cedars-Sinai Medical Center, the Women's Guild Endowed Chair in Women's Health, the Barbra Streisand Endowment for Women's Heart Research and Education Program, and PI on three investigator initiated research grants funded by NIH. She serves in an advisory role to investigators and sponsors, including as Chair of a DSMB for NIH and on advisory boards for the American Heart Association and American College of Cardiology. She received honoraria for lecturing at Stanford University, Association of Black Cardiologists, Berlin Heart Institute, Madera Medical Society, Argentine Society of Cardiology, American College of Physicians, MedReviews/CVT, Mayo Clinic, University of New Mexico, Northwestern University, MedCon, University of California, Davis, and Abbott Laboratories. She serves as consultant to Novartis, CMP Media, Rodale Press, University of Pittsburgh, Centers for Disease Control, Adventist Health, Bayer, Remillard and Associates, Navigant, Hunt and Associates, Pfizer, NIH, Karolinska Institute, Strategy Group, Biological Systems Processing-BSP. She holds stock in Eli Lilly, Medtronic, Johnson and Johnson, as well as small amounts of stocks with Boston Scientific, Teva Pharmaceuticals, and ATS Medical.Dr. Borer serves on DSMBs or cardiac event adjudication committees for Salix. Celladon, NovaCardia, Pfizer, Takeda, Gilead and the NIH. He serves as consultant to Servier, BioMarin, ARMGO, Johnson and Johnson, Savient, Indigo, Hoffmann-La Roche, and Sanofi.
PII: S0002-9343(08)01062-0
doi: 10.1016/j.amjmed.2008.10.021
« Previous
Next »
The American Journal of Medicine
Volume 122, Issue 4
, Pages 315-316
, April 2009

