Journal Club - 2006-05-09

Number needed to treat

Examples

1. Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, Ederer F. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med. 1993 May 13;328(19):1365-71. Erratum in: N Engl J Med 1993 Aug 26;329(9):672. PMID: 8474513 Link

2. Julius S, Nesbitt SD, Egan BM, Weber MA, Michelson EL, Kaciroti N, Black HR, Grimm RH Jr, Messerli FH, Oparil S, Schork MA; Trial of Preventing Hypertension (TROPHY) Study Investigators. Feasibility of treating prehypertension with an angiotensin-receptor blocker. N Engl J Med. 2006 Apr 20;354(16):1685-97. Epub 2006 Mar 14. PMID: 16537662 ; NEJM

PDA emulator

Never be the first not the last doc on the block to prescribe a new medicine

Johnston SL, Blasi F, Black PN, Martin RJ, Farrell DJ, Nieman RB; TELICAST Investigators. The effect of telithromycin in acute exacerbations of asthma. N Engl J Med. 2006 Apr 13;354(15):1589-600. PMID: 16611950 ; NEJM

• Efficacy; NNT=
• Adversity (hepatic); NNH=

Clay KD, Hanson JS, Pope SD, Rissmiller RW, Purdum PP 3rd, Banks PM. Brief communication: severe hepatotoxicity of telithromycin: three case reports and literature review. Ann Intern Med. 2006 Mar 21;144(6):415-20. Epub 2006 Feb 15. Review. Summary for patients in: Ann Intern Med. 2006 Mar 21;144(6):I42. PMID: 16481451 ; Annals

General References

Begaud B, Moride Y, Tubert-Bitter P, Chaslerie A, Haramburu F. False-positives in spontaneous reporting: should we worry about them? Br J Clin Pharmacol. 1994 Nov;38(5):401-4. PMID: 7893579

Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255-9. PMID: 11072960 ; doi:10.1016/S0140-6736(00)02799-9 

Proposed change to FDA approval process

Strom BL. How the US drug safety system should be changed. JAMA. 2006 May 3;295(17):2072-5. PMID: 16670415 ; JAMA

Additional factors in this case

Mathews AW. Infected Data: Fraud, Errors Taint Key Study Of Widely Used Sanofi Drug. WSJ:

• The doctor who treated the most patients in the study, Maria "Anne" Kirkman Campbell, is in federal prison after pleading guilty to defrauding Aventis and others. An indictment says Dr. Campbell fabricated data she sent to the company. The documents show that Aventis was worried about Dr. Campbell early in study 3014 but didn't tell the FDA until the agency's own inspectors discovered the problem independently.
• A doctor in California who treated the third-most patients in the study was on probation at the time with the state medical board for gross negligence and failure to keep adequate records. Shortly after his involvement in the study ended, police responding to a domestic-violence call found the doctor at home hiding a bag of cocaine in his underwear and holding a loaded semiautomatic handgun, according to a later complaint by the California medical board. The doctor lost his license.
• The full extent of the study's problems has never been made public. Its results were cited last month in an article in the New England Journal of Medicine that suggested Ketek is as safe as other antibiotics. Five of the six authors of that article disclosed that they received consulting fees from Sanofi-Aventis, and the sixth was an Aventis employee at the time of the study.