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Re: NCI...redux
It seems that my screed on NCI (referenced by link to the original posting) elicited severe criticism from at least one party. It was not for the language I used (and I do apologize to Moon and others of fair countenance if they were offended in the least, though none has so advised me of having fainted), but rather for what one person asserted was my total ignorance regarding NCI’s contribution to the science of immunology in general and the development of Provenge in particular.
More specifically, my critic (to put it mildly) reminds me that it was the US taxpayer and other government agencies, including the NCI, that “…allowed DNDN scientists to push the envelop (sic) a bit by tweaking the technology.”
Now, If what Dendreon did in developing Provenge was to ‘tweak’ the technology, then I would respectfully aver that what the Manhattan Project did during WWII in developing the A-bomb was nothing more than to ‘tweak’ Einstein's General Theory of Relativity.
NCI is no friend on Dendreon or Provenge. We saw that not only in the fact a high-level NCI employee attended the meeting called at the FDA following the March 29, 2007, Provenge Advisory Committee meeting to discuss the development of Dr. Howard I. Scher’s letter to Dr. von Eschenbach, but also, in Alison Martin’s editing of that letter …the letter that was leaked to The Cancer Letter either before or just after it was delivered to the FDA.
Dr. Martin was one busy writer/editor, indeed, as you can see from this FOIA release to Care To Live. If you will scroll down to p. 11 of the document in the URL below, you will find a letter being prepared by NCI for delivery to Sen. Daniel Inouye. The letter, which was due to be mailed July 16, 2007 (all congressional inquiries are put on a fast track), was in response to one inquiring into the status of Provenge.
http://caretolive.com/NCI-FOIA-Response.pdf
As you can see, NCI put the senator off, telling him to “[P]lease contact the FDA for specific information pertaining to the approval process and the status of the Dendreon Corp. application for Provenge.”
Fair enough.
But then, we are treated to the following: “NCI has a robust research portfolio in prostate cancer and provided $293.2 million in FY2006 and support is estimated to remain at this level for FY 2007 and FY 2008.” So, in those three years alone, if this held true, NCI spent almost ONE BILLION on prostate cancer research (and probably another ONE BILLION) in the period FY2009-FY2011, incl. And still, they are a far way down the road from the planned Phase III trials.
I hope their trials are a success. I hope all those working on prostate cancer push the envelope and in the end find a cure. But NCI, or at least some of its people, have willfully worked to stop Provenge in its tracks, and we have the evidence to prove it.
Further, damning the treatment by faint praise, as Gulley, Slovin, and others have done is unprofessional, in the extreme.
Even more unprofessional is Slovin’s statement late last year, to wit: ‘Memorial Sloan Kettering's Susan Slovin said she thought Provenge would be used, just not as enthusiastically as it was at first. She summed it up for Reuters this way: "[Zytiga] is taking the market by storm; there is a much faster effect with it," Slovin said. "Pain is markedly improved, along with the ability to eat, drink, go out and do what they normally would do. The patient says, 'Look, I really don't see the need to sit here and send my (blood) to wherever...I want to take a pill and go to Florida.' "’
What great medical advice. Go ahead…take Zytiga pre-chemo…off-label, even though it has the second lowest rating in Provenge’s space…and take the risk that you will progress beyond the point where you no longer are eligible for Provenge.
http://jco.ascopubs.org/content/29/27/3595.full?sid=a9e276db-0ac1-4ca1-8fd4-a16a19e7151f#sec-14
I thought the first thing doctors learned in school was: First do no harm.
So, I stand by my post on NCI. They are spending my money. I hope they succeed in their endeavors.
In the meantime, they should keep their mouths shut and their noses to the grindstone.
War
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