Biotech Values

[DewDiligence]

BPUR – You posted but one paragraph of the WSJ article
about Dr. Natanson. More to the point, your omission of
the excerpts shown below leaves a false impression
vis-à-vis the magnitude of the non-disclosure offense.

http://online.wsj.com/article/SB121598988902149353.html

›July 14, 2008

…[Dr. Natanson] said the companies are trying to use the omission to discredit the study's findings. "The science stands and the conclusion stands, no question," said Dr. Natanson. The paper was published online in April and appeared in JAMA May 21.

Dr. Natanson said he submitted an erratum July 7 to the JAMA disclosing his role in the pending patent along with a response to a letter to the editor about the original study. He said he also disclosed the pending patent in writing at a joint FDA/NIH hearing on blood substitutes held the day the paper appeared online.

…The main inventor on the patent application is Mark Gladwin, another NIH researcher, who wasn't involved in the JAMA paper. The application seeks a patent for a process that reduces the toxicity of blood substitutes, and thus could improve their chances of reaching the market. The NIH has sent letters to companies it thinks might be interested in licensing the technology.

Two co-authors on the JAMA paper are Sidney Wolfe and Peter Lurie, both of the Washington, D.C., watchdog group Public Citizen, a critic of conflict of interest in medicine. Dr. Wolfe agrees the information should have been disclosed, but he defended the paper's conclusions.

So did William Hoffman, director of cardiac critical intensive care at Massachusetts General Hospital and former medical director at Biopure. "The paper went through a solid and rigorous review," said Dr. Hoffman, who wasn't involved with the study, but who has worked with Dr. Natanson in the past.‹