Biotech Values

[its_the_oxygen]

"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."

I did not omit anything of importance. The article is easily found with a simple google search. This is all the back peddling he is doing to wiggle out of the hot water he fell into. The magnitude of the offense is SERIOUS whether you agree or not. When you stand to rake in between 1.5 to 2.5 million dollars from a "miracle additive" that you invented and claim will SAVE the HBOC industry and the companies you try to liscense it to both tell you to "get lost".....that was enough inspiration to call up Wolfe and help construct the meta-analysis that is both retaliatory and seriously scientifically flawed. If Biopure liscensed this additive and sent Natanson and Gladwin a check for 4 or 5 million we would not be having this conversation because this article would never have been written or published.

…[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.

I guess that's why Jay Epstien himself found the article to be flawed and said it "lacks scientific merit" at the HBOC meetings in early April. Also, less than one month later the Journal of Trauma published their own study findings which TOTALLY contradict Natanson's findings.

"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.'

His erratum was submitted THREE MONTHS after the paper was published. Too little, too late. He's trying to fix his mistake by doing more back peddling. His disclosure in writing to FDA/NIH means NOTHING because they do not share that information with JAMA and it is JAMA that he should have disclosed the conflict to! PERIOD. He told the WSJ he forgot to disclose to JAMA but I submit that he thought it could have been a deal breaker for JAMA so he intentionally omitted this significant conflict to get the crap-analysis published. Read this portion of Biopure's response to this Jama paper as the facts demonstrate that this was a well timed and orchestrated attack:

"Public Citizen, a self proclaimed consumer advocacy organization, and Dr. Natanson did not, by all appearances, set out merely to offer a scientific contribution. Rather, they, with JAMA, caused publication of this controversial article before the normal print date to coincide with and adversely color the dialogue at the NIH/FDA workshop in April, a workshop in which people with extensive knowledge, including the FDA, were assembled to see whether or not there was a way forward for HBOCs. The authors subsequently sent letters to foreign governmental regulatory agencies in Greece, England, The Netherlands and South Africa, where Biopure's product has ongoing clinical trials or market approval or both, asking them to shut down all clinical trial usage of Hemopure. This behavior indicates unscientific zeal."


"…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."

NO ONE WAS INTERESTED and they PITCHED BIOPURE MOST AGGRESSIVELY WITH HIGH PRESSURE SALES TACTICS MAKING STATEMENTS LIKE "you are dead in the water without us".

"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."

Sid Wolfe agrees that he screwed up. JAMA would not have published his crap-analysis if they were aware of this conflict, so I'm sure, although he agrees that Natanson screwed up, he is nothing short of delighted that it was squeezed through without him having to catch any heat. Sid Wolfe could NOT have written this paper WITHOUT Natanson's help.

"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."

I cannot go into why Hoffman has an axe to grind but let's just say that he is angry to have been "caught with his pants down" and subsequntly asked to resign as medical director at Biopure and that's all I'll say about that. Him and Natanson were bunk mates and co-graduates at the same university. They are buddies. Read between the lines.