| [1] | National Institutes of Health (2002 July 9) NHLBI stops trial of estrogen plus progestin due to increased breast cancer risk, lack of overall benefit [news release]. Bethesda (Maryland): National Institutes of Health. Available: http://www.nhlbi.nih.gov/new/press/02-07？-09.htm. Accessed 13 February 2006 .
|
| [2] | Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, et al. (2002) Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial. JAMA 288: 321–333.
|
| [3] | Barrett-Connor E (2004) Commentary: Observation versus intervention—What's different? Int J Epidemiol 33: 457–459.
|
| [4] | US Preventive Services Task Force (2002) Chemoprevention for hormone replacement therapy. Rockville (Maryland): US Preventive Services Task Force. Available: http://www.ahrq.gov/clinic/uspstf/uspspm？ho.htm. Accessed 18 February 2006 .
|
| [5] | Hennekens CH, Buring JE, Manson JE, Stampfer M, Rosner B, et al. (1996) Lack of effect of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. N Engl J Med 334: 1145–1149.
|
| [6] | The Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group (1994) The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med 330: 1029–1035.
|
| [7] | Omenn GS, Goodman GE, Thornquist MD, Balmes J, Cullen MR, et al. (1996) Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med 334: 1150–1155.
|
| [8] | Blot WJ, Li JY, Taylor PR, Guo W, Dawsey S, et al. (1993) Nutrition intervention trials in Linxian, China: Supplementation with specific vitamin/mineral combinations, cancer incidence, and disease-specific mortality in the general population. J Natl Cancer Inst 85: 1483–1492.
|
| [9] | Packer M, Bristow MR, Cohn JN, Colluci WS, Fowler MB, et al. (1996) The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med 334: 1349–1355.
|
| [10] | Australia/New Zealand Heart Failure Research Collaborative Group (1997) Randomized, placebo-controlled trial of carvedilol in patients with congestive heart failure due to ischaemic heart disease. Lancet 349: 375–380.
|
| [11] | CIBIS-II Investigators and Committees (1999) The cardiac insufficiency bisoprolol study II (CIBIS-II); A randomized trial. Lancet 353: 9–13.
|
| [12] | Hjalmarson A, Goldstein S, Fagerberg B, Wedel H, Waagstein F, et al. (2000) Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: The Metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. JAMA 283: 1295–1302.
|
| [13] | CIBIS Investigators and Committees (1994) A randomized trial of beta-blockade in heart failure. The cardiac insufficiency bisoprolol study (CIBIS). CIBIS investigators and committees. Circulation 90: 1765–1773.
|
| [14] | Barton S (2000) Which clinical studies provide the best evidence? BMJ 321: 255–256.
|
| [15] | Clarke M (2004) Doing new research? Don't forget the old. PLoS Med 1: e35. doi: 10.1371/journal.pmed.0010035.
|
| [16] | Young C, Horton R (2005) Putting clinical trials into context. Lancet 366: 107–108.
|
| [17] | GRADE Working Group (2004) Grading quality of evidence and strength of recommendations. BMJ 328: 1490.
|
| [18] | LeLorier J, Gregoire G, Benhaddad A, Lapierre J, Derderian F (1997) Discrepancies between meta-analyses and subsequent large randomized, controlled trials. N Engl J Med 337: 536–542.
|
| [19] | Furukawa TA, Streiner DL, Hori S (2000) Discrepancies among megatrials. J Clin Epidemiol 53: 1103–1109.
|
| [20] | [No authors listed] (2004 September 30) Merck announces voluntary worldwide withdrawal of VIOXX. Available: http://www.merck.com/newsroom/vioxx_with？drawal/pdf/vioxx_press_release_final.pdf. Accessed 17 February 2006 .
|
| [21] | Eisenberg RS (2005 31 March) Learning the value of drugs—Is rofecoxib a regulatory success story? N Engl J Med 352: 1285–1287.
|
| [22] | [Anonymous] (2005 February 19) FDA panel opens door for return of Vioxx. Washington Post; Sect A: 1.
|
| [23] | FDA Center for Drug Evaluation and Research (2005 April 7) FDA announces important changes and additional warnings for COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). Rockville (Maryland): FDA Center for Drug Evaluation and Research. Available: http://www.fda.gov/cder/drug/advisory/CO？X2.htm. Accessed 13 February 2006 .
|
| [24] | Food and Drug Administration (2004 October 15) Suicidality in children and adolescents being treated with antidepressant medications. A public health advisory. Rockville (Maryland): Food and Drug Administration. Available: http://www.fda.gov/cder/drug/antidepress？ants/SSRIPHA200410.htm. Accessed 8 January 2006.
|
| [25] | Lipp E (2005 May 15) Cutting through the biomarker hype. Genet Eng News 25: 1,14,16.
|
| [26] | Thompson IM, Goodman PJ, Tangen CM, et al. (2003) The influence of finasteride on the development of prostate cancer. N Engl J Med 349: 213–122.
|
| [27] | Thompson IM, Ankerst DP, Chi C, Lucia MS, Goodman PJ, et al. (2005) Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/ml or lower. JAMA 294: 66–70.
|
| [28] | The Diabetes Control and Complications Trial Research Group (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329: 977–986.
|
| [29] | Nocturnal Oxygen Therapy Trial Group (1980) Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: A clinical trial. Ann Intern Med 93: 391–398.
|
| [30] | Prentice RL (1989) Surrogate end points in clinical trials: Definition and operational criteria. Stat Med 8: 431–440.
|
| [31] | Baker SG, Kramer BS, Prorok PC (2004) Development tracks for cancer prevention markers. Dis Markers 20: 97–102.
|
| [32] | Ransohoff DF (2005) Bias as a threat to the validity of cancer molecular-marker research. Nat Rev Cancer 5: 142–149.
|
| [33] | Ransohoff DF (2005) Lesson from controversy: Ovarian cancer screening and serum proteomics. J Natl Cancer Inst 97: 315–319.
|
| [34] | Wacholder S, Chanock S, Garcia-Closas M, El Ghormli L, Rothman N (2004 March 17) Assessing the probability that a positive report is false: An approach for molecular epidemiology studies. J Natl Cancer Inst 96: 434–442.
|
| [35] | Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG (2004) Empirical evidence for selective reporting of outcomes in randomized trials: Comparisons of protocols to published articles. JAMA 291: 2457–2465.
|
| [36] | Woloshin S, Schwartz LM (2004) Association of aspirin use and hormone receptor status with breast cancer risk. JAMA 292: 1426–1427.
|
| [37] | Cook NR, Lee IM, Gaziano JM, Gordon D, Ridker PM, et al. (2005 July 6) Low-dose aspirin in the primary prevention of cancer: The Women's Health Study: A randomized controlled trial. JAMA 294: 47–55.
|
| [38] | Schwartz L, Woloshin S (2004) The media matter: A call for straightforward medical reporting. Ann Intern Med 140: 226–228.
|
