The balance of benefit and safety of rosiglitazone: important lessons for our system of drug development and postmarketing assessment

Recent issues of Pharmacoepidemiology and Drug Safety contain three articles and two letters that offer perspective about the ongoing controversy concerning the role of rosiglitazone in the treatment of diabetes mellitus. Each paper provides unique insights that contribute to the overall story, yet our understanding remains vexingly incomplete. Moreover, the uncertainty that lingers after reading these reports highlights increasingly manifest deficiencies in the U.S. regulatory system, as well as in the global

[1]  G. Koch,et al.  A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14 237 patients with type 2 diabetes mellitus enrolled in 42 short‐term, double‐blind, randomized clinical studies with rosiglitazone , 2008, Pharmacoepidemiology and drug safety.

[2]  Reena Rao,et al.  Thiazolidinediones expand body fluid volume through PPARγ stimulation of ENaC-mediated renal salt absorption , 2005, Nature Medicine.

[3]  J. Verbalis,et al.  Rosiglitazone Activates Renal Sodium- and Water-Reabsorptive Pathways and Lowers Blood Pressure in Normal Rats , 2004, Journal of Pharmacology and Experimental Therapeutics.

[4]  Harlan M Krumholz,et al.  Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. , 2008, JAMA.

[5]  C. Koro,et al.  Studies of diabetes, thiazolidinediones, and coronary heart disease , 2007, Pharmacoepidemiology and drug safety.

[6]  C. Thiemermann,et al.  Beneficial effects of PPAR-γ ligands in ischemia–reperfusion injury, inflammation and shock , 2005 .

[7]  Alastair J J Wood,et al.  A proposal for radical changes in the drug-approval process. , 2006, The New England journal of medicine.

[8]  D. DeMets,et al.  Principles From Clinical Trials Relevant to Clinical Practice: Part II , 2002, Circulation.

[9]  D. DeMets,et al.  The independent statistician for data monitoring committees , 2004, Statistics in medicine.

[10]  Alfonso T. Perez,et al.  A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes , 2007, Pharmacoepidemiology and drug safety.

[11]  K. Brown,et al.  GI262570, a Peroxisome Proliferator-Activated Receptor γ Agonist, Changes Electrolytes and Water Reabsorption from the Distal Nephron in Rats , 2005, Journal of Pharmacology and Experimental Therapeutics.

[12]  D. DeMets,et al.  Principles from clinical trials relevant to clinical practice: Part I. , 2002, Circulation.

[13]  A. Kesselheim,et al.  Pharmaceutical promotion to physicians and First Amendment rights. , 2008, The New England journal of medicine.

[14]  R. Kronmal,et al.  Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. , 2008, JAMA.

[15]  Coronary heart disease outcomes in patients receiving antidiabetic agents in the PharMetrics database 2000–2007 , 2008, Pharmacoepidemiology and drug safety.

[16]  Catherine D DeAngelis,et al.  Impugning the integrity of medical science: the adverse effects of industry influence. , 2008, JAMA.

[17]  C. Thiemermann,et al.  Beneficial effects of PPAR-gamma ligands in ischemia-reperfusion injury, inflammation and shock. , 2005, Cardiovascular research.

[18]  P Glasziou,et al.  Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial , 2005, The Lancet.

[19]  Robert M Califf,et al.  Curbing the cardiovascular disease epidemic: aligning industry, government, payers, and academics. , 2007, Health affairs.