References

Americans growing less confident in FDA’s job in safety, poll shows. 2006. The Wall Street Journal Online, May 24.

Berry D, Gillie I, Forster M. 1997. What do patients want to know about their medications and what do doctors want to tell them? A comparative study. Psychology of Health 12:467–480.

Chalasani N, Aljadhey H, Kesterson J, Murray MD, Hall SD. 2004. Patients with elevated liver enzymes are not at higher risk for statin hepatoxicity. Gastroenterology 126(5):1287–1292.

Cohen JT, Bellinger DC, Connor WE, Kris-Etherton PM, Lawrence RS, Savitz DA, Shaywitz BA, Teutsch SM, Gray GM. 2005. A quantitative benefit–risk analysis of changes in population fish consumption. American Journal of Preventive Medicine 29(4):325–334.

Classen DC, Pestotnik SL, Evans RS, Burke JP. 1991. Computerized surveillance of adverse drug events in hospital patients. Journal of the American Medical Association 266:2847–2851.

Edwards A, Elwyn G, Mulley A. 2002. Explaining risks: turning numerical data into meaningful pictures. British Medical Journal 324:827–830.

Farwell WR, Stump TE, Wang J, Tafesse E, L’Italien G, Tierney WM. 2004. Weight gain and new onset diabetes associated with olanzapine and risperidone. Journal of General Internal Medicine 19(12):1200–1205.

FDA. 2007. FDA’s Mission Statement. [Online] Available: http://www.fda.gov/opacom/morechoices/mission.html [accessed May 31, 2007].

Gramling R, Irvin JE, Nash J, Sciamanna C, Culpepper L. 2004. Numeracy and medicine:Numeracy and medicine: key family physician attitudes about communicating probability with patients. Journal of the American Board of Family Practice 17:473.

Gray GM, Hammitt JK. 2000. Risk/risk trade-offs in pesticide regulation: an exploratory analysis of the public health effects of a ban on organophosphate and carbamate pesticides. Risk Analysis 20:665–680.

Honigman B, Less J, Rothschild J, Light P, Pulling RM, Yu T, Bates DW. 2001. Using computerized data to identify adverse drug events in outpatients. Journal of the American Medical Informatics Association 8:254–266.



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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary References Americans growing less confident in FDA’s job in safety, poll shows. 2006. The Wall Street Journal Online, May 24. Berry D, Gillie I, Forster M. 1997. What do patients want to know about their medications and what do doctors want to tell them? A comparative study. Psychology of Health 12:467–480. Chalasani N, Aljadhey H, Kesterson J, Murray MD, Hall SD. 2004. Patients with elevated liver enzymes are not at higher risk for statin hepatoxicity. Gastroenterology 126(5):1287–1292. Cohen JT, Bellinger DC, Connor WE, Kris-Etherton PM, Lawrence RS, Savitz DA, Shaywitz BA, Teutsch SM, Gray GM. 2005. A quantitative benefit–risk analysis of changes in population fish consumption. American Journal of Preventive Medicine 29(4):325–334. Classen DC, Pestotnik SL, Evans RS, Burke JP. 1991. Computerized surveillance of adverse drug events in hospital patients. Journal of the American Medical Association 266:2847–2851. Edwards A, Elwyn G, Mulley A. 2002. Explaining risks: turning numerical data into meaningful pictures. British Medical Journal 324:827–830. Farwell WR, Stump TE, Wang J, Tafesse E, L’Italien G, Tierney WM. 2004. Weight gain and new onset diabetes associated with olanzapine and risperidone. Journal of General Internal Medicine 19(12):1200–1205. FDA. 2007. FDA’s Mission Statement. [Online] Available: http://www.fda.gov/opacom/morechoices/mission.html [accessed May 31, 2007]. Gramling R, Irvin JE, Nash J, Sciamanna C, Culpepper L. 2004. Numeracy and medicine:Numeracy and medicine: key family physician attitudes about communicating probability with patients. Journal of the American Board of Family Practice 17:473. Gray GM, Hammitt JK. 2000. Risk/risk trade-offs in pesticide regulation: an exploratory analysis of the public health effects of a ban on organophosphate and carbamate pesticides. Risk Analysis 20:665–680. Honigman B, Less J, Rothschild J, Light P, Pulling RM, Yu T, Bates DW. 2001. Using computerized data to identify adverse drug events in outpatients. Journal of the American Medical Informatics Association 8:254–266.

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Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary IOM (Institute of Medicine). 2006. Valuing Health for Regulatory Cost-Effectiveness Analysis. Washington, DC: The National Academies Press. Jha AK, Kuperman GJ, Teich JM, Leape L, Shea B, Rittenberg E, Burdick E, Seger DL, Vliet MV, Bates DW. 1998. Identifying adverse drug events: development of a computer-based monitor and comparison with chart review and stimulated voluntary report. Journal of the American Medical Informatics Association 5:305–314. National Research Council. 1983. Risk Assessment in the Federal Government: Managing the Process. Washington, DC: National Academy Press. National Research Council. 1999. Health Effects of Exposure to Radon, BEIR VI. Washington, DC: National Academy Press. Nease Jr. RF, Kneeland T, O’Connor GT, Sumner W, Lumpkins C, Pryor D, Sox HC. 1995. Variation in patient utilities for outcomes of the management of chronic stable angina. Implications for clinical practice guidelines. Ischemic Heart Disease Patient Outcomes Research Team. Journal of the American Medical Association 273(15):1185–1190. OMB (Office of Management and Budget). 2005. Validating Regulatory Analysis: 2005 Report to Congress on the Costs and Benefits of Federal Regulations and Unfunded Mandates on State, Local, and Tribal Entities. Washington, DC: OMB Sheiner LB. 1997. Learning vs. confirming in clinical drug development. Clinical Pharmacology and Therapeutics 61:275–291. Spiegel BM, Targownik L, Dulai GS, Gralneck IM. 2003. The cost-effectiveness of cyclooxygenase-2 selective inhibitors in the management of chronic arthritis. Annals of Internal Medicine 138(1):795–806. Stossel TP. 2005. Regulating academic-industrial research relationships—solving problems or stifling progress? New England Journal of Medicine 353:1060–1065. Strom BL. 2006. How the U.S. drug safety system should be changed. Journal of the American Medical Association 295:2072–2075. Weinstein ND. 1999. What does it mean to understand a risk? Evaluating risk comprehension. Journal of the National Cancer Institute 25:15–20. Woloshin S, Schwartz LM, Welch HG. 2004. The value of benefit data in direct-to-consumer drug ads. Health Affairs Suppl Web Exclusives: W4-234–W4-245.