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September 17, 2008

Incomplete Financial Disclosure in a Study of Cell-Free Hemoglobin-Based Blood Substitutes and Risks of Myocardial Infarction and Death

JAMA. 2008;300(11):1300. doi:10.1001/jama.300.11.1300-a

To the Editor: I would like to report an incomplete financial disclosure resulting from my oversight in not including my involvement in a US Government Provisional Patent Application in the Financial Disclosures in the meta-analysis on cell-free hemoglobin-based blood substitutes (HBBSs) and risks of myocardial infarction and death.1

In the Financial Disclosures section of the article, I reported that I had been paid $10 000 by Hemosol Inc to review a cardiac surgery trial of its HBBS product and that I had served as an unpaid special government consultant to the Food and Drug Administration on the HBBS product Hemopure (made by Biopure Corp, Cambridge, Massachusetts). However, I failed to disclose that my name is listed with Dr Mark T. Gladwin and other National Institutes of Health investigators on a US Provisional Application relating to hemoglobin-based oxygen carriers (HBOCs) that was filed in August of 2007. The Provisional Application relates to a method of using nitrite bound to methemoglobin to reduce the deleterious effects associated with HBOC use as blood substitutes. Although the preclinical work underlying this application was performed in my laboratory, it did not involve HBOCs and I did not participate in the preparation of the provisional filing. I have asked that my name not be listed as an inventor if and when a patent application is filed. The application's current status remains a “provisional claim” (DHHS Reference No. E-259-2007/0–US Provisional Application No. 60/996,530 filed 31 Aug 2007).