by Kerry M. Donahue

FDA commissioner Margaret Hamburg recently defended the FDA against criticisms leveled by former FDA Deputy Commissioner Dr. Scott Gottlieb and Hoover Institute fellow Henry Miller. She took issue with the idea that the FDA is not following the mandates of Congress to get safe and effective new treatments to patients in a timely way, particularly late stage patients with few, if any, viable alternatives.

Of course those who followed the Provenge approval process with CareToLive understand that FDA figurehead Hamburg is baffled, befuddled and completely out of touch with the reality of the situation. Ms. Hamburg needs to look no further than the case of Provenge and the now 15 other effective treatments for late stage diseases that heroes like Frank Burroughs at the Abigail Alliance http://abigail-alliance.org/ supported, and which were all eventually approved for treatment of life threatening diseases. Unfortunately not before hundreds of thousands of patients died, sometimes from terrible and painful diseases, without ever having been able to obtain these treatments.

The fault lies squarely with the FDA process and their failure to prioritize and accelerate review as demanded by Congress, and by humanity itself. Continue Reading FDA Trifecta — Gottlieb Calls Em Out, Miller Rallies on the Rail, Hamburg Limps Lamely to Finish »

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I prepared for orals expecting a lot of questions. There were not many questions asked by Judge Norris or Judge Martin but quite a few by Judge Cook. Judge Norris and Martin are a couple of salty old dogs and seem a bit more lighthearted then many of their stiffer brethren.

I had 15 minutes, 5 of which I saved for rebuttal. I presented the issue and spoke about how this case was different then most FOIA cases in that we know that there were, and maybe still are, requested documents on the computer of a single individual at the FDA.

We know this by virtue of Richard Pazdur’s admittance that he had the documents on his computer but he deleted them. So in this case the CDER division of the FDA knows where to look. Continue Reading Care To Live Attorney Kerry M. Donahue Argues for Pazdur’s Deleted Documents »

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Dr. Myers’s thoughts on Provenge.
http://askdrmyers.wordpress.com/2010/07/07/provenge-case-study/ (video)

About Dr. Snuffy Myers http://askdrmyers.wordpress.com/about/
With over 250 research papers published, Myers is one of the leading developers of today’s prostate cancer canon on both the research and treatment side of the test tube. Prostate Forum is the educational arm of his world-renowned practice that is dedicated to providing men with the comprehensive care that saved his own life.

Care To Live friend M.C. Lee summed it up.

- Longer survival
- Less side effect
- Comparable cost
- Productive life

M. C. Lee Edit: Forgot that demand will definitely outstrip supply in the FORESEEABLE future.  So if you want it you better bug your doctor about it.

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The real story—the tragedy in this case, and the one yet to be told by the so-called “Mainstream Media”—is the story of the needless three-year delay in availability of Dendreon’s Provenge for our sons, fathers, and grandfathers.

The Dendreon Investor Village (IV) message board at www.investorvillage.com(link) is where a group of the most well-informed people in the world on all-things-Dendreon, exchange information. Many have posted there non-stop since early in the decade. One daily post entitled “Daily Death Count”, documents the number of men who have died of prostate cancer since “Black Wednesday” (link to Mark Thornton op ed), May 8, 2007, the date the FDA went against the recommendation of its own Advisory Committee and refused to approve Provenge. As of this past Thursday, the date Provenge received final approval, the death count stood at 90,055. Every one of these 90,055 men were deeply loved and now dearly missed by their families and friends.

It’s difficult to ignore the fact that the March 29, 2007 Provenge Advisory Committee voted unanimously (17-0) that the drug is SAFE, or the fact that the same Committee voted minutes later, (13-4) that the drug “demonstrated substantial evidence of efficacy,” the federally mandated standard in such reviews. But the FDA did. The FDA also ignored the fact that the treatment was being submitted to help men with end stage prostate cancer, the stage for which there is no viable treatment option. Provenge would have been their last resort. Continue Reading The Real Provenge Story »

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The honorable Pat Tiberi, House Representative from the 12th District of Ohio, refuses to accept a brush off by the FDA.

Representative Tiberi continues to doggedly pursue answers from the FDA as to why the ongoing delay of Provenge for late stage prostate cancer patients, continues without excuse.

Tiberii is a true Patriot, seeking answers for the men needlessly waiting on the dysfunctional FDA to do its job.

See his second recent inquiry to the FDA here (click below to enlarge) or download here pattiberi02.pdf

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FDA’s CBER Gone Fishing While Men Gone Wishing

Read it here http://www.nowpublic.com/health/fdas-cber-gone-fishing-while-men-gone-wishing 

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FDA’S Cber Sipping New Year’s Champagne Burst Patient’s Bubbles

http://my.nowpublic.com/health/fdas-cber-sipping-new-years-champagne-burst-patients-bubbles

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Hold the deck.

It’s certainly okay to have the opinion that the FDA made a reasonable choice at the time it denied approval to Provenge in 2007. It’s not the right opinion, but it is a defendable one. It is not all right, based on what we now know, to say they made the right decision.

On the other hand:

That the Provenge BLA was not afforded proper due process is an absolute. Because it clearly was not afforded proper due process nobody can say with any certainty that the FDA made a reasonable decision. Once the process is corrupted it’s all guesswork from there. Nobody knows for sure the extent of influences and back room shenanigans that occurred to assure that Provenge was not fairly evaluated. When CareToLive through litigation and FOIA’s tried to get information they were stymied by the FDA who went to great lengths to avoid any transparency on the issue.

There are aces scattered all over the floor at the FDA and a couple sticking out of a few sleeves so how can the game have been fairly played? Is it too much to ask for a fair game? The denial of a fair PROCESS is the one truth that the FDA could have, should have, admitted.

If that process occurred in a court room there would, at a minimum, have been declared a mistrial, when the evidence of such became known (which was made known to the FDA by petition, litigation and of course lots of letters).

That they did not make a reasonable and common sense decision based on the class of patients for which Provenge was seeking approval, or conduct a proper risk/benefit analysis with a focus on the fact that the treatment was destined for late stage patients is clear.

The FDA said two things that support this; One was that the minority voices on the AC panel were taken into consideration as a factor in the decision making process, and Two is that Richard Pazdur of CDER influenced that process. Top that off with an FDA commissioner who just happens to be a very good friend of Milken……

I don’t want the point to be lost that it is the position of CareToLive that there is no way anyone can say a reasonable decision was made, because the process was completely corrupted. CareToLive has sought accountability and transparency to determine in what ways the process fell short. If the FDA would show us the process then we might be persuaded otherwise. Until then and even because of the cover up itself, it has to be evaluated based on what we know.

The cover up and the lack of transparency is indicative that the FDA made a choice that transparency would make matters worse in this case. Otherwise, why fight so hard to keep the process from the public eye.

What other influences entered into the picture. Political pressure? Milken pressure? Financial pressure? Inside power struggles? Some or all of the above?

The deck was stacked. The dice were loaded. Everybody knows!

With all that you now know about Milken and the depths of his depravity, does it not trouble you that he had considerable control and influence over at least Scher, Martin and von Eschenbach if not others? Continue Reading American Hold ‘Em »

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CareToLive Attorney Kerry Donahue filed Plaintiff’s Reply to Defendant’s Memorandum in Opposition Plaintiff’s Motion for Leave to Conduct Discovery Under Civil Rule 56(f)

You can read the response here >> Response for Discovery

See Exhibit A >> exhibit-a-061609.pdf

See Exhibit B >> exhibit-b-061609.pdf

See Exhibit C* >> exhibitc.pdf

*Exhibit C — Taken from Demystifying Computer Forensics written by Johnette Hassell, Ph.D. and Susan Steen
CareToLive would like to thank the authors who were kind enough to let us use excerpts from their document — demystifying-computer-forensics.pdf . Johnette Hassell and Susan Steen are partners in Electronic Evidence Retrieval, L.L.C., a company specializing in computer forensics and other expert consultation and testimony in computer science. They have more than twenty years of experience in computer consultation and testimony, computer forensics, software and technical manual copyright infringement support, and programmatic research and evaluation. They can be reached at info@ElectronicEvidenceRetrieval.com or 504.483.0201 on the Gulf Coast and 970.922.7250 in the Rocky Mountain area. http://www.electronicevidenceretrieval.com/

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MOTION FOR LEAVE TO CONDUCT/COMPLETE DISCOVERY UNDER CIVIL RULE 56(f)
AND PARTIAL MEMORANDUM CONTRA TO DEFENDANT FDA’S MOTION FOR SUMMARY JUDGMENT

Now Comes Plaintiff, CareToLive, on behalf of its members and all suffering late stage prostate cancer patients and their families who have now been denied a proven safe and effective treatment for over two years and request leave from this Court to conduct a limited amount of discovery so as to more fully respond to the Motion for Summary Judgment filed by Defendant, as further set forth in the attached memorandum.

Link to Motion >> ctlfoiaresponse6-06-09c.pdf

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