Today Care To Live received additional documents from the Center of Medicaid and Medicare Services in response to our Freedom of Information (FOIA) requests.

part-1-cms-foia-3_30_11.pdf

part-2-cms-foia-3_30_11.pdf

part-3-cms-foia-3_30_11.pdf

part-4-cms-foia-3_30_11.pdf

part-5-cms-foia-3_30_11.pdf

part-6-cms-foia-3_30_11.pdf

part-7-cms-foia-3_30_11.pdf

part-8-cms-foia-3_30_11.pdf

part-9-cms-foia-3_30_11.pdf

part-10-cms-foia-3_30_11.pdf

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Care To Live has been notified by the Department of Justice (DOJ) that the final FOIA response from CMS is expected to be completed and released to CTL not later than April 15, 2011.

As soon as it is released, it will be posted here in its entirety.

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Today CTL received an interim response to its two previous FOIA request made to CMS. The documents were retrieved upon a search performed by Dr Louis Jacques. We received 258 pages of which 74 pages were redacted under claimed exemptions of FOIA (5 U.S.C. 552 (b)(2), (b)(5) and (b)(6)).

Although the pdf’s are not in 100% chronological order it is probably easiest to comprehend each of the 5 individual pdfs, from back to front.

1-cms-foia-0221.pdf

2-cms-foia-02211.pdf

3-cms-foia-02-21.pdf

4-cms-foia–02-21.pdf

5-cms-foia-0221.pdf

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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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Care To Live To FDA, “Just Produce the Documents”.

Public servants. Hah! More like royalty in gilded cages. Conspiring in their posh abodes to put the kebosh on a cancer treatment without adequate reasons or transparency into their warped decision making process. They can’t use no favorable Advisory Committee hearings. Not when there was so much money on the table.

We seek confirmation of the corruption and retribution commensurate with the crime.

Who was lobbying the FDA and why?

The Care To Live Birthers are here.

Just produce the documents.

We fully intend to continue to force the issue including the removal of the inner sanctum of corrupt officials at the FDA, the CMS, the NCI and the HHS, who have been sabotaging our medical research, destroying valid, impressive, breakthough treatments and delaying approvals for years while they enrich themselves.

How blatant they are in their inconsistency. For such a statistically anal organization, the FDA can’t add one and one and get two. What a sneaky bunch of manipulating, self enriching bureaucrats, who through ignorance or greed, sabotaged a nation.

We demand consistent parameters for one treatment over another.

Yeah, Provenge is approved now. So what difference does it make?

It is at the very core of our democracy that these “regulatory” agencies, who get such a huge chunk of our tax dollars, actually do the jobs they are overpaid to do.

Transparency and Accountability.

FOIA OR BUST!

Join us!

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Care To Live Counsel Kerry M. Donahue sent a letter to the Centers for Medicaid and Medicare Services (CMS), as a final gesture to resolve the Freedom Of Information (FOIA) conflicts with their agency. However, if the the status quo remains, and we receive no response, Kerry has already started preparing litigation against them and will file on December 10, 2010, if they choose to go down that road.

(Click picture to enlarge. Download pdf here kerrydonahuecmsletter.pdf)

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CareToLive has been notified of its Courtroom and Judge assignment in case 09-4084 CareToLive v. FDA.

Wednesday, December 08, 2010, room 636 - 6th Floor East Courtroom, 9:00 A.M.

Before: Judge Boyce F. Martin Jr., Senior Judge Alan E. Norris and Judge Deborah L. Cook

Oral argument will be heard by this three judge panel on Wednesday, December 8, 2010 at 9:00 a.m. at the Potter Stewart U.S. Courthouse, 100 East Fifth St in Cincinnati, Ohio.

CTL’s filing in the Court of Appeals was in response to the FDA’s refusal to search Richard Pazdur’s computer or the FDA servers for documents that satisfy our FOIA request.

Dr. Pazdur had made a Declaration stating he destroyed all said documents. Kerry states, “Merely asking the fox to count the chickens, without even allowing Plaintiff-Appellant to subject the answers of the fox to any sort of test of accuracy or truthfulness, was improper.”

You can read Kerry’s fine legal filing here: ctlfoiaappellantreplyeditedii030310pdf.pdf

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CareToLive is proud to announce that our counsel, Kerry M. Donahue, has been named the 2010 recipient of the Florida Out of State President’s Pro Bono Service Award. The award is presented annually by the Chief Justice of the Supreme Court of Florida to the attorney who best exemplifies the highest ideals of the profession in assuring the availability of legal services to those that cannot afford or are unable to obtain legal representation.As those who follow the work of CareToLive know, Kerry has worked long and hard hours since May of 2007 on a pro bono basis, in the uphill battle to obtain Provenge for late stage prostate cancer patients.Kerry will be receiving the award from the Chief Justice at an award ceremony on January 28 in Tallahassee, Florida.We at CareToLive thank Kerry for his dedicated effort on behalf of our cause and are pleased to see that he is receiving this well deserved recognition!

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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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Michael Milken, 60,000 Deaths, and the Story of Dendreon (Chapter 1 of 15)

18 June 2009 by Mark Mitchell

What follows is part 1 of a 15 part series. The remaining installments will appear on Deep Capture over the next several weeks, after which point the story will be published in its entirety. It is a story about the travails of just one small company, but it describes market machinations that have affected hundreds of other companies, and it contains a larger message for anyone concerned about the “deep capture” of our nation’s media and regulatory bodies.

This story, like too many others, begins with Jim Cramer, the CNBC personality, making “a mistake.”

On September 26, 2005, Cramer  announced to his television audience the sad news (punctuated by funny sound effects – a clown horn, a crashing airplane) that Provenge, an experimental treatment for prostate cancer, had flopped. Thousands of end-stage patients had been pinning their hopes on Provenge, but according to Cramer the treatment had just been rejected by the Food & Drug Administration. It would never go to market.

Read It Here >>http://www.deepcapture.com/michael-milken-60000-deaths-and-the-story-of-dendreon/

http://www.DeepCapture.com

http://www.deepcapture.com/michael-milken-60000-deaths-and-the-story-of-dendreon-chapter-1-of-15/

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