[e-drug] Unethical blood substitute trials

["Sidney Wolfe" <swolfe@citizen.org>]

E-DRUG: Unethical blood substitute trials
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Please help stop unethical blood substitute trials in 8 countries by writing to the health ministers

Despite evidence from earlier trials of increased deaths and heart attacks with these products, trials are currently being conducted in the UK, Sweden, Netherlands, the Czech Republic, Poland, Belgium, Greece and South Africa. 
 
Our meta-analysis in the JAMA several weeks ago documenting this can be found at:   
 
http://jama.ama-assn.org/cgi/content/full/299.19.jrv80007
 	
ABSTRACT
CLINICIAN'S CORNER
Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death

A Meta-analysis

Charles Natanson, MD; Steven J. Kern, BS; Peter Lurie, MD, MPH; Steven M. Banks, PhD{dagger}; Sidney M. Wolfe, MD

JAMA. 2008;299(19):2304-2312. Published online April 28, 2008 (doi:10.1001/jama.299.19.jrv80007).

Context  Hemoglobin-based blood substitutes (HBBSs) are infusible oxygen-carrying liquids that have long shelf lives, have no need for refrigeration or cross-matching, and are ideal for treating hemorrhagic shock in remote settings. Some trials of HBBSs during the last decade have reported increased risks without clinical benefit.

Objective  To assess the safety of HBBSs in surgical, stroke, and trauma patients.

Data Sources  PubMed, EMBASE, and Cochrane Library searches for articles using hemoglobin and blood substitutes from 1980 through March 25, 2008; reviews of Food and Drug Administration (FDA) advisory committee meeting materials; and Internet searches for company press releases.

Study Selection  Randomized controlled trials including patients aged 19 years and older receiving HBBSs therapeutically. The database searches yielded 70 trials of which 13 met these criteria; in addition, data from 2 other trials were reported in 2 press releases, and additional data were included in 1 relevant FDA review.

Data Extraction  Data on death and myocardial infarction (MI) as outcome variables.

Results  Sixteen trials involving 5 different products and 3711 patients in varied patient populations were identified. A test for heterogeneity of the results of these trials was not significant for either mortality or MI (for both, I2 = 0%, P ≥ .60), and data were combined using a fixed-effects model. Overall, there was a statistically significant increase in the risk of death (164 deaths in the HBBS-treated groups and 123 deaths in the control groups; relative risk [RR], 1.30; 95% confidence interval [CI], 1.05-1.61) and risk of MI (59 MIs in the HBBS-treated groups and 16 MIs in the control groups; RR, 2.71; 95% CI, 1.67-4.40) with these HBBSs. Subgroup analysis of these trials indicated the increased risk was not restricted to a particular HBBS or clinical indication.

Conclusion  Based on the available data, use of HBBSs is associated with a significantly increased risk of death and MI.
 
Copies of our letters to the eight health ministers urging that they halt the trials can be found at:
 
http://www.citizen.org/publications/release.cfm?ID=7583 
 
Please send copies to me of letters you send urging these trials be stopped. 
 
Please also send copies of your letters to interested press in your countries.
 
Thanks
 
Sidney M.Wolfe M.D.
Director, Health Research Group of Public Citizen
1600 20th St. NW, Washington, DC. 20009
202 588-7735  fax 588-7796
e-mail swolfe@citizen.org
Web sites: www.citizen.org/hrg
www.worstpills.org