CBS News | The Worst-Case Scenario | January 29, 2006
In case you missed “60 Minutes” last night, they did this story on Hollis-Eden and Project Bioshield, which I ‘ve discussed in these pages previously. As only 60 Minutes can do, they made Stewart Simonson, DHHS’ man in charge of government procurement of medicines to treat the effects of targeted warfare against U.S. cirizens, look like a completely inept, arrogant asshole. Maybe he is. Maybe he isn’t. I don’t know, but I laughed out loud at 60 Minutes caricature of the man. In any case, 60 Minutes made no attempt to describe exactly what Neumune from Hollis-Eden is, how it works, or how effective it is. So, I figured I’d just fill in those blanks.
Neumune is 5-Androsten-3{beta}, 17{beta}-Diol (a.k.a. androstenediol), a steroidal “androstene” metabolically derived from the weak androgen DHEA, that in preclinical studies protects against hematopoetic depletion following radiation and cytotoxic chemotherapy exposure. Beta androstenetriol increases the levels of the TH(1) cytokines, IL-2, IL-3, IFN gamma and counteracts hydrocortisone-mediated immune suppression. Hollis-Eden has exclusive rights to develop the drug from Virginia Commonwealth University (Roger Loria of VCU invented the clinical use). The drug has been studied in Phase 1 clinical trials in humans, preliminary results of which were presented in October 2005. These results indicated that Neumune was well tolerated and was associated with dose-dependent increases in neutrophils and platelets. Phase 2 and 3 clinical trials are not required by FDA for U.S. approval, as they would be unethical for the intended use. Extensive preclinical studies, most of which have not been published in peer-reviewed journals, have demonstrated that Neumune can reduce the incidence and duration of severe neutropenia following systemic radiation exposure and cytotoxic chemotherapy (e.g carboplatin). At ASH 2005, Hollis-Eden presented data from a preclinical meta-analysis, involving 100 non-human primates (rhesus macaques) demonstrating an ~50% decrease in mortality following total body irradiation (42% vs. 22%) and post-exposure treatment with Neumune.
February 2nd, 2006 at 11:43 am
It is a shame that HHS assistant secretary Simonson and Dr. Anthony Fauci of NIH are putting US Citizens at risk by not procuring enough of thie drug to be stockpiled around the country. 100,000 doses won’t even cover the bureaucrats in DC. I hope they get this product to market.
February 2nd, 2006 at 11:45 am
It is astounding that HHS can have a guy like Simonson in charge of this program! HHS should be purchasing 500,000 doses for each major city at minimum. I suspect that Dr. Fauci wants to spread more grants around to his “patrons” than protect the American People!