Reform of drug regulation - Beyond an independent drug-safety board

New England Journal of Medicine

Volumn 354, Issue 2, 2006, Pages 194-201

  Ray, Wayne A ^a   Stein, C Michael ^a  

^a VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CERIVASTATIN; CISAPRIDE; CYCLOOXYGENASE 2 INHIBITOR; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; FENFLURAMINE; NON PRESCRIPTION DRUG; NONSTEROID ANTIINFLAMMATORY AGENT; PHENTERMINE; PROTON PUMP INHIBITOR; ROFECOXIB; SEROTONIN UPTAKE INHIBITOR; TERFENADINE; TROGLITAZONE;

ACUTE HEART INFARCTION; ANGIONEUROTIC EDEMA; CARDIOTOXICITY; CARDIOVASCULAR DISEASE; CLINICAL PRACTICE; CLINICAL TRIAL; DRUG APPROVAL; DRUG INDUSTRY; DRUG INFORMATION; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HEART ARRHYTHMIA; HORMONE SUBSTITUTION; HUMAN; LICENCE; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL SOCIETY; OFF LABEL DRUG USE; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; PULMONARY HYPERTENSION; REVIEW; RHABDOMYOLYSIS; RISK BENEFIT ANALYSIS; SUICIDAL BEHAVIOR; SUICIDAL IDEATION; TORSADE DES POINTES; UNSPECIFIED SIDE EFFECT; VALVULAR HEART DISEASE;

HEALTH CARE AND PUBLIC HEALTH;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG INDUSTRY; HEALTH CARE REFORM; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 30444449389     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMsb053432     Document Type: Review

References (54)

1. Psaty BM, Furberg CD. COX-2 inhibitors - lessons in drug safety. N Engl J Med 2005;352:1133-5.
2. Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveillance - lack of vigilance, lack of trust. JAMA 2004;292:2647-50.
3. Wood AJ, Stein CM, Woosley R. Making medicines safer - the need for an independent drug safety board. N Engl J Med 1998;339:1851-4.
4. Okie S. Safety in numbers - monitoring risk in approved drugs. N Engl J Med 2005;352:1173-6.
5. Joint Commission on Prescription Drug Use. Final report. Washington, D.C.: Government Printing Office, 1980.
6. Ray WA, Griffin MR, Avorn J. Evaluating drugs after their approval for clinical use. N Engl J Med 1993;329:2029-32.
7. Woosley RL. Centers for education and research in therapeutics. Clin Pharmacol Ther 1994;55:249-55.
8. Chlebowski RT, Hendrix SL, Langer RD, et al. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women's Health Initiative Randomized Trial. JAMA 2003;289:3243-53.
9. Woosley RL. Cardiac actions of antihistamines. Annu Rev Pharmacol Toxicol 1996;36:233-52.
10. Woosley RL, Chen Y, Freiman JP, Gillis RA. Mechanism of the cardiotoxic actions of terfenadine. JAMA 1993;269:1532-6.
11. Ray WA. Population-based studies of adverse drug effects. N Engl J Med 2003;349:1592-4.
12. Brown NJ, Ray WA, Snowden M, Griffin MR. Black Americans have an increased rate of angiotensin converting enzyme inhibitor-associated angioedema. Clin Pharmacol Ther 1996;60:8-13.
13. Committee on Drugs, American Academy of Pediatrics. Uses of drugs not described in the package insert (off-label uses). Pediatrics 2002;110:181-3.
14. Connolly HM, Crary JL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med 1997;337:581-8. [Erratum, N Engl J Med 1997;337:1783.]
15. Abenhaim L, Moride Y, Brenot F, et al. Appetite-suppressant drugs and the risk of primary pulmonary hypertension. N Engl J Med 1996;335:609-16.
16. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled? Ann Intern Med 1996;125:605-13.
17. Psaty BM, Furberg CD, Ray WA, Weiss NS. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and the risk of rhabdomyolysis. JAMA 2004;292:2622-31.
18. Gale EA. Lessons from the glitazones: a story of drug development. Lancet 2001;357:1870-5.
19. Graham DJ, Staffa JA, Shatin D, et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA 2004;292:2585-90.
20. Lanza FL. A guideline for the treatment and prevention of NSAID-induced ulcers. Am J Gastroenterol 1998;93:2037-46.
21. Hawkey CJ, Karrasch JA, Szczepanski L, et al. Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med 1998;338:727-34.
22. Okie S. What ails the FDA? N Engl J Med 2005;352:1063-6. [Erratum, N Engl J Med 2005;352:2563.]
23. Angell M. The truth about the drug companies. New York: Random House, 2004.
24. Slater EE. Today's FDA. N Engl J Med 2005;352:293-7.
25. Effect of user fees on drug approval times, withdrawals, and other agency activities. Washington, D.C.: General Accounting Office, 2002. (Document no. GAO-02-958.)
26. Topol EJ. Failing the public health - rofecoxib, Merck, and the FDA. N Engl J Med 2004;351:1707-9.
27. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343:1520-8.
28. Landefeld CS. Commercial support and bias in pharmaceutical research. Am J Med 2004;117:876-8.
29. Nissen SE. High-dose statins in acute coronary syndromes: not just lipid levels. JAMA 2004;292:1365-7.
30. Meadows M. The FDA's drug review process: ensuring drugs are safe and effective. FDA Consum 2002;36(4):19-24.
31. Woosley RL. Drug labeling revisions - guaranteed to fail? JAMA 2000;284:3047-9.
32. Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: impact of Food and Drug Administration regulatory action. JAMA 2000;284:3036-9.
33. Graham DJ, Drinkard CR, Shatin D, Tsong Y, Burgess MJ. Liver enzyme monitoring in patients treated with troglitazone. JAMA 2001;286:831-3.
34. Griffin MR, Stein CM, Graham DJ, Daugherty JR, Arbogast PG, Ray WA. High frequency of use of rofecoxib at greater than recommended doses: cause for concern. Pharmacoepidemiol Drug Saf 2004;13:339-43.
35. Meadows M. Why drugs get pulled off the market. FDA Consum 2002;36(1):11-7. [Erratum, FDA Consum 2002;36(3):3.]
36. Harris G. F.D.A. to create advisory board on drug safety. The New York Times. February 16, 2005:A1.
37. Wood AJJ, Drazen JM, Greene MF. A sad day for science at the FDA. N Engl J Med 2005;353:1197-9.
38. Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA 1990;263:549-56.
39. 'Off-label' promo allowed as FDA appeal is dismissed. Are drug firms protected? Medical Marketing and Media 2000;35(3):6.
40. Steinbrook R. Financial conflicts of interest and the Food and Drug Administration's advisory committees. N Engl J Med 2005;353:116-8.
41. Griffin MR, Stein CM, Ray WA. Postmarketing surveillance for drug safety: surely we can do better. Clin Pharmacol Ther 2004;75:491-4.
42. Rawlins MD. 5 NICE years. Lancet 2005;365:904-8.
43. Wiseman LR, Faulds D. Cisapride: an updated review of its pharmacology and therapeutic efficacy as a prokinetic agent in gastrointestinal motility disorders. Drugs 1994;47:116-52.
44. Temple RJ. Government viewpoint of clinical trials of cardiovascular drugs. Med Clin North Am 1989;73:495-509.
45. Temple RJ. Idem. When are clinical trials of a given agent vs. placebo no longer appropriate or feasible? Control Clin Trials 1997;18:613-20.
46. Campbell WH, Califf RM. Improving communication of drug risks to prevent patient injury: proceedings of a workshop. Pharmacoepidemiol Drug Saf 2003;12:183-94.
47. Avorn J, Soumerai SB. Improving drug-therapy decisions through educational outreach: a randomized controlled trial of academically based "detailing." N Engl J Med 1983;308:1457-63.
48. Bradley EH, Carlson MD, Gallo WT, Scinto J, Campbell MK, Krumholz HM. From adversary to partner: have quality improvement organizations made the transition? Health Serv Res 2005;40:459-76.
49. Soumerai SB, McLaughlin TJ, Gurwitz JH, et al. Effect of local medical opinion leaders on quality of care for acute myocardial infarction: a randomized controlled trial. JAMA 1998;279:1358-63.
50. Bates DW, Gawande AA. Improving safety with information technology. N Engl J Med 2003;348:2526-34.
51. Califf RM. The need for a national infrastructure to improve the rational use of therapeutics. Pharmacoepidemiol Drug Saf 2002;11:319-27.
52. Briss PA. Evidence-based: US road and public-health side of the street. Lancet 2005;365:828-30.
53. Avorn J. Powerful medicines: the benefits, risks, and costs of prescription drugs. New York: Alfred A. Knopf, 2004.
54. Silverman M, Lee PR. Pills, profits, and politics. Berkeley: University of California Press, 1974.