Postmarketing surveillance - Lack of vigilance, lack of trust

JAMA

Volumn 292, Issue 21, 2004, Pages 2647-2650

  Fontanarosa, Phil B ^a   Rennie, Drummond ^b   DeAngelis, Catherine D ^b  

^a JAMA   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CERIVASTATIN; CYCLOOXYGENASE 2 INHIBITOR; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; ROFECOXIB; SEROTONIN UPTAKE INHIBITOR;

CARDIOVASCULAR DISEASE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOXICITY; EDITORIAL; ETHICS; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TOXICITY; HEALTH CARE POLICY; HUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; SUICIDE;

EID: 9644302576     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.292.21.2647     Document Type: Editorial

References (35)

1. Prescription Drug User Fee Act of 1992, Pub L No. 102-571, 21 USC §379, 106 Stat 4491 (1992).
2. US General Accounting Office. Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities. Washington, DC: General Accounting Office; 2002. Publication GAO-02-958.
3. Carpenter D, Chernow M, Smith DG, Fendrick AM. Approval times for new drugs: does the source of funding for FDA staff matter? Health Aff (Millwood). 2003;(suppl Web exclusives):W3-618-W3-624.
4. Cauchon D. FDA advisers tied to industry. USA Today. September 25, 2000:A1.
5. Carpenter DP. The political economy of FDA drug review: processing, politics, and lessons for policy. Health Aff (Millwood). 2004;23:52-63.
6. Pear R. Drug companies increase spending to lobby congress and governments. New York Times. May 31, 2003:33.
7. Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions. JAMA. 1999;281:824-829.
8. Califf RM. The need for a national infrastructure to improve the rational use of therapeutics. Pharmacoepidemiol Drug Saf. 2002;11:319-327.
9. Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med. 2003;18:57-60.
10. Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies - Department of Health and Human Services: Notice of Availability, 69 Federal Register 50 (2004).
11. Rennie D. Trial registration: a great idea switches from ignored to irresistible. JAMA. 2004;292:1359-1362.
12. Silverstein FE, Faich G, Goldstein JL, et al; Celecoxib Long-Term Arthritis Safety Study. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA. 2000;284:1247-1255.
13. Hrachovec JB, Wright JM. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA. 2001;286:2398-2399.
14. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naprosyn in patients with rheumatoid arthritis. N Engl J Med. 2000;343:1520-1528.
15. Dieppe PA, Ebrahim S, Juni P. Lessons from the withdrawal of rofecoxib. BMJ. 2004;329:867-868.
16. Topol EJ. Failing the public health - rofecoxib, Merck, and the FDA. N Engl J Med. 2004;351:1707-1709.
17. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 2001;286:954-959.
18. Mathews AW, Martinez B. E-mails suggest Merck knew Vioxx's dangers at early stage. Wall Street Journal. November 1, 2004:A1.
19. Juni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet [serial online]. November 5, 2004. Available at: http://image.thelancet.com/extras/04art10237web.pdf. Accessed November 10, 2004.
20. Kaufman M. FDA official alleges pressure to suppress Vioxx findings. Washington Post. October 8, 2004:A23.
21. Mathews AW. FDA officials tried to tone down report on Vioxx. Wall Street Journal. October 8, 2004:B2.
22. 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 risk of rhabdomyolysis. JAMA. 2004;292:2622-2631.
23. Strom B. Potential for conflict of interest in the evaluation of suspected adverse drug reactions: a counterpoint. JAMA. 2004;292:2643-2646.
24. Piorkowski JD. Bayer's response to "Potential for conflict of interest in the evaluation of susgected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis." JAMA. 2004;292:2655-2657.
25. Psaty BM, Furberg CD, Ray WA, Weiss NS. Authors' reply to Bayer's response to "Potential for conflict of interest in the evaluation of suspected adverse drug reactions: use of cerivastatin and risk of rhabdomyolysis." JAMA. 2004;292:2658-2659.
26. Graham DJ, Staffa JA, Shatin D, et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA. 2004;292:2585-2590.
27. Rennie D. Thyroid storm. JAMA. 1997;277:1238-1243.
28. UCSF News Office. UCSF-Harvard team publishes major HIV therapy study over objections of sponsor: compound shows no effect on slowing disease progression. October 31, 2000. Available at: http://pub.ucsf.edu/newsservices/ releases/2004010228. Accessed November 10, 2004.
29. The global giants. Wall Street Journal. September 27, 2004:R10.
30. Moore TJ, Psaty BM, Furberg CD. Time to act on drug safety. JAMA. 1998;279:1571-1573.
31. FDA acts to strengthen the safety program for marketed drugs [press release]. Rockville, Md: Food and Drug Administration; November 5, 2004. Available at: http://www.fda.gov/bbs/topics/news/2004/NEW01131.html. Accessed November 11, 2004.
32. Harris G. FDA's drug review safety system will get outside review. New York Times. November 6, 2004:A9.
33. Wood AJ, Stein CM, Woosley R. Making medications safer: the need for an independent drug safety board. N Engl J Med. 1998;339:1851-1854.
34. Griffin MR, Stein CM, Ray WA. Postmarketing suveillance for drug safety: surely we can do better. Clin Pharmacol Ther. 2004;75:491-494.
35. US Food and Drug Administration. Report to Congress: reports on postmarketing studies. Available at: http://www.fda.gov/cber/fdama/ pstmrktfdama130.htm. Accessed November 10, 2004.