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Key Publications in Pharmacoepidemiology & Patient Safety

Study Examples | Key Publications | Intro

A few key publications are listed below:

The United States lacks population-based systems to detect adverse events rapidly after new vaccines are introduced. The leaders of this study used years of data from four health plans in the Vaccine Safety Datalink. They followed each week's vaccinated children for four weeks, comparing rates of adverse events with rates among children of similar ages before the new vaccine was introduced. They concluded that it is feasible to develop systems for rapid and routine population-based assessments of new vaccine safety.

—Davis RL, Kolczak M, Lewis E, Nordin J, Goodman M, Shay DK, Platt R, Black S, Shinefield H, Chen RT (2005). Active surveillance of vaccine safety: a system to detect early signs of adverse events. Epidemiology, 16 (3): 336–341.

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In November 2004, Bruce M. Psaty, MD, PhD, testified before the U.S. Senate Finance Committee about the flaws in the research that the pharmaceutical industry conducted to gain Food and Drug Administration (FDA) approval to market rofecoxib (Vioxx). In March 2005, he gave the Senate Health, Education, Labor, and Pensions Committee recommendations about changes in FDA drug safety systems that are needed to prevent future Vioxx-like problems. Psaty recently agreed to serve on the Institute of Medicine committee to review FDA drug safety policies and procedures.

—Psaty BM, Furberg CD (2005). COX-2 inhibitors—lessons in drug safety. New England Journal of Medicine, 352 (11): 1133–1135.

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The study assessed whether the use of statins altered the risk of breast carcinoma in older women by comparing 975 women with breast cancer to 1,007 women without breast cancer. Compared with nonusers, women who were currently using statins or had ever used statins were not at increased risk for breast carcinoma; however, this area warrants further confirmatory study.

—Boudreau DM, Gardner JS, Malone KE, Heckbert SR, Blough DK, Daling JR (2004). The association between 3-hydroxy-3-methylglutaryl coenzyme A inhibitor use and breast carcinoma risk among postmenopausal women: a case-control study. Cancer, 100 (11): 2308–2316.

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U.S. patients are often the first to receive new medications, which may subsequently be discovered to have adverse drug reactions. The challenge of early detection has shifted to the U.S. postmarketing safety-surveillance system; but this system did not adequately call attention to the association between using cerivastatin (or cervistatin with gemfibrozil) and much larger risks of rhabdomyolysis than other statins. The authors propose that the U.S. Congress mandate and adequately support postmarketing reviews by an independent group, not the pharmaceutical companies whose economic interests may influence their appraisals.

—Psaty BM, Furberg CD, Ray WA, Weiss NS (2004). Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis. Journal of the American Medical Association, 292: 2622–2631.

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In this study of more than 10,000 women, those who took antibiotics for more than 500 days (or more than 25 individual prescriptions) during their enrollment at Group Health had twice the risk of breast cancer as those who had taken no antibiotics. More research is proposed to evaluate whether it is actually the antibiotics that lead to an increased risk of breast cancer.

—Velicer CM, Heckbert SR, Lampe JW, Potter JD, Robertson CA, Taplin SH (2004). Antibiotic use in relation to the risk of breast cancer. Journal of the American Medical Association, 291: 827–835.

Study Examples | Key Publications | Intro

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