CareToLive’s continual pursuit of the infamous personal opinion Dr. Howard Scher offered to NCI’s Alison Martin, hit a brick wall again January 29th, when William H. Hall, the Director of the News Division of the Office of the Assistant Secretary for Public Affairs, voted against handing Scher’s email over to CareToLive as requested under the Freedom of Information Act. Mr. Hall made some outrageous claims. Mr. Hall writes:

“After review of the redacted language, I find that it reveals nothing about the FDA proceeding. Rather, the redacted language contains Dr. Scher’s private thoughts as expressed to a professional colleague.”

Mr. Hall went on to say, “[Y]ou believe that because Dr. Scher served in some official capacity, anything he may have said about Provenge is public information. Dr. Scher is not a government employee and he does not forfeit his right to have personal information and details of his life protected from public disclosure simply due to his service on a government committee. As mentioned above, the redacted language does not address the FDA’s decision.”

Mr. Hall’s full letter appears below.

CareToLive would like to point out Mr. Hall’s errors.

Dr. Scher was a government employee when he wrote his personal opinion to Alison Martin. Scher wrote it one day after he served on the Provenge Advisory Committee.

The evidence will show that Scher was already planning on supplementing, as well as contradicting his own opinions at the Advisory hearing, by drafting a follow up letter to the FDA with regards to Provenge. Scher frantically lobbied the FDA not to approve Provenge.

Prior to the Provenge Advisory Committee, Scher signed a waiver which stated he was a special Government employee:

http://caretolive.com/2007-4291-w-07-Sche-208r.pdf

In addition, in the case CTL vs. FDA, the Department of Justice stated Scher must be granted immunity since he is a government official.

http://www.caretolive.com/Ctlscherdismmotion.pdf

At Page 13

Drs. Pazdur and Sher must be granted qualified immunity in their individual capacities at this stage of the litigation on plaintiff’s claims that they violated the United States Constitution.

At Page 14

“Qualified immunity protects government officials performing discretionary functions from suit for damages as long as their conduct “does not violate clearly established statutory or constitutional rights of which a reasonable person would have known.” Harlow, 457 U.S. at 18–19. Qualified immunity “is an immunity from suit rather than a mere defense to liability.””

Mr. Hall emphasizes that the redacted language in Scher’s email did not address the FDA’s decision on Provenge. That misses the point that Scher was trying to influence the FDA’s decision as this email was sent prior to the FDA making its decision to delay the approval of Provenge.

It is clear that Scher was seeking information and assistance from NCI employee Alison Martin as to how best to understand the FDA process, so as to most effectively influence it, to get the result he desired.

http://caretolive.com/NCI-FOIA-Response.pdf

_______________________________________________________________________________________________________

——-Original Message——–

From: Howard Scher

To: Martin, Alison (NIH/NCI) [E]

Sent: Fri, Mar 30 21:14:28 2007

Subject: Re: With your blessings – will circulate to authors this week

What did you think of the ODAC?

——-Original Message——–

From: Martin, Alison (NIH/NCI) [E] [mail to:martina@ctep.nci.hih.gov]

Sent: Friday, March 30, 2007 9:49 PM

To: Scher, Howard I. / Medicine

Subject: Re: With your blessings – will circulate to authors this week

Couldn’t go but it is quite the buzz at NCI -  not sure we understand - not sure it meant it would be approved. You were there - please tell me if you were convinced.

——-Original Message——–

From: Scher, Howard

Sent: Saturday, March 31, 2007 8:49 AM

To: Martin, Alison (NIH/NCI) [E]

Subject:   [ PERSONAL INFORMATION WITHHELD ]

Body:  [ PERSONAL INFORMATION WITHHELD ]

Howard I. Scher, M.D.

D. Wayne Calloway Chair in Urologic Oncology

Department of Medicine
Sidney Kimmel Center for Prostate and Urologic Cancers

Memorial Sloan-Kettering C ancer Center

1275 York Ave.

New York, NY 10021

Tel; Administrative: 646-422-4323

Clinical: 646-422-4330

FAX: 212-988-0851

Email: Scher@mskcc.org

——-Original Message——–

From: Martin, Alison (NIH/NCI) [E] [mail to:martina@ctep.nci.hih.gov]

To: Scher, Howard I. / Medicine

Sent: Sat Mar 31  6:15:05 2007

Su bject: Re: With your blessings – will circulate to authors this week

Glad to hear letter is being drafted. If that division’s vote suggests it be considered for approval, I was wondering if it then could go to the ODA, which is more clinically savy, i.e., this is just a step in the process.

Here is Mr. Hall’s full letter:

DEPARTMENT OF HEALTH & HUMAN SERVICES

OFFICE OF THE SECRETARY

WASHINGTON, D.C. 20201

This is in response to your October 27, 2008, letter in which you appealed the National Institute of Health’s (NIH) decision to withhold email language between Dr. Howard Scher and Alison Martin, National Cancer Institute (NCI) regarding Dendreon Corporation’s Provenge cancer drug.

In your appeal you first state that Exemption 6 does not apply because the email exchange is not a “similar” file with the definition of the FOIA. However, the term is interpreted broadly and includes all information that applies to a particular individual. Because the email text at issue applies directly to Dr. Scher, it satisfies the threshold requirement. You further state that even if Exemption 6 applies, the redacted language is not personal privacy information about Dr. Scher and, consequently, he has no privacy interest in its content.

After review of the redacted language, I find that it reveals nothing about the FDA proceeding. Rather, the redacted language contains Dr. Scher’s private thoughts as expressed to a professional colleague.

You stated that you believe that because Dr. Scher served in some official capacity, anything he may have said about Provenge is public information. Dr. Scher is not a government employee and he does not forfeit his right to have personal information and details of his life protected from public disclosure simply due to his service on a government committee. As mentioned above, the redacted language does not address the FDA’s decision.

You assert that the public has a right to know why Provenge was not approved. This argument is not relevant to this FOIA request because the requested material does not shed light on the reason(s) why FDA did not approve the drug. NIH did release those portions of the email that did not constitute an unwarranted invasion of personal privacy even where the information did not shed light on the FDA process or any other government operation.

My review indicates that NIH properly withheld the personal comments unrelated to government operations under Exemption (b)(6) of the FOIA. Exemption (b)(6) permits the withholding of privacy information the release of which would constitute a clearly unwarranted invasion of personal privacy.

This letter constitutes the final decision of the Department in this matter. If you wish, you may seek judicial review in the district court of the United States in the district in which you reside, or your principal place of business, or in which the agency records are located, or the District of Columbia.

Sincerely,

William H. Hall

Director, News Division

Office of the Assistant Secretary

for Public Affairs

In conclusion, CareToLive is currently considering District Court action to compel disclosure. CTL believes this decision is completely contrary to the law as stated in the Freedom of Information Act and is currently exploring the opportunity to commence District Court action against the Department of Health & Human Services.

Popularity: 4%

When looking at The Freedom of Information Act [5 USCS § 552], notice what it states in Section 3:

B) Each agency shall make reasonable efforts to maintain its records in forms or formats that are reproducible for purposes of this section.

C) In responding under this paragraph to a request for records, an agency shall make reasonable efforts to search for the records in electronic  form or format, except when such efforts would significantly interfere with the operation of the agency’s automated information system.

(D) For purposes of this paragraph, the term “search” means to review, manually or by automated means, agency records for the purpose of locating those records which are responsive to a request.

The FDA responded to this by saying such a search for documents sent to and from Richard Pazdur would be complex. Then the FDA mistakenly told the court that such a request would be too costly, not realizing the requester pays for it.  After the search was completed, Richard Pazdur simply declared that he deleted and shredded the documents two years ago and CareToLive had to pay 40 cents for this complex search! 40 cents!

You can’t even purchase one of these for 40 cents!

Sadly, the Court in the Southern District of Ohio ruled in favor of FDA.

CareToLive’s fine attorney, Kerry M. Donahue, filed an appeal this past August and last night he filed our Appellate brief (Appellant’s brief) which is our written argument for the 6th Circuit Court of Appeals which they will review and then probably set up for oral argument.

The FDA (Appellee) has 15 days to file their response, but we would not be surprised if they get an extra 2 weeks after that if they need it.

You can read the brief here>>   ctlappealfoia11172009pdf.pdf

Here are some highlights:

“The Appelle has consistently argued that the Provenge matter is still an “ongoing process” so the destruction of documents regarding an ongoing process demands further inquiry.“

“Either way the FDA did not perform the “complex” search that it promised the Court and Appellant that it was conducting.”

“The search time incurred by the FDA CDER division FOIA office was so slight that it did not even register on the radar as a significant reportable/billable search time. That was the entire “complexity” of the search and response.”

“…the FDA told inquiring members of Congress that they did in fact conduct an internal investigation.”

” It does not cost the Defendant anything!“

Popularity: 27%

On November 2, 2009 the Dendreon Corporation announced it had completed the submission of the amended Biologics License Application (BLA) for Provenge, also known as sipuleucel-T, to the U.S. Food and Drug Administration (FDA).Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). When approved by the FDA, PROVENGE would represent the first product in the new therapeutic class known as active cellular immunotherapies.

By December 25, 2009, CareToLive expects to see FDA approve Provenge based on FDA’s response to CTL’s Citizens Petition.

Dendreon presented the original BLA to the FDA in March, 2007. The FDA granted it Fast Track Status and Priority Review. FDA then used our tax dollars to assemble a panel of experts to advise them at an Advisory Committee hearing. That panel stated Provenge is safe by a vote of 17-0 and that Provenge showed substantial evidence of efficacy by a vote of 13-4. Two weeks after that panel recommended approval, some conflicted doctors who were worried about competitive Phase II treatments they were working on and what investors thought while having their own investments riding on the final FDA decision, lobbied the FDA to delay approval. After three letters were leaked, which showed collusion with some doctors at NCI, FDA denied approval on May 8, 2007. Among the leaked letters was a statement by NCI saying it did not support Provenge, rather it had a robust portfolio which included support for the competitive Phase II treatments mentioned above.

Dendreon proceeded with its IMPACT trial. In October, 2008, an Independent Data Monitoring Committee reported that the interim data showed Provenge had a safe profile and a 20% survival advantage over placebo. The FDA stood idly by and ignored this data which supported the original BLA.

On April 14, 2009, Dendreon announced Provenge significantly prolongs survival in men with advanced prostate cancer. The final data showed once again a safe profile and the survival advantage was now at 22.5%. To put that in perspective, 96,000 men in the United States have advanced prostate cancer, 30,000 of them will die. 22.5% of 30,000 means 6,750 lives would be saved. The FDA continues to stand coldheartedly by.

CareToLive continues to challenge the FDA. It still seeks FOIA documents from NCI and FDA. A senior official at the FDA, Richard Pazdur, declared he deleted and shredded those documents. With men’s lives hanging in the balance, our government agencies should not be participating in such shenanigans. CTL will hold FDA to its words.

When FDA responded to the CTL Citizens Petition, it said three times it would expeditiously review the data. We are holding them to it.

http://caretolive.com/wp-content/uploads/2009/05/fda-response-to-citizens-petition.pdf

                                          FDA Statement To CTL On May 21, 2009

Page 1:
“We are committed to expeditiously reviewing the new information as soon as it is submitted. FDA shares the goal of approving new products, such as Provenge, as soon as they are shown to be safe and effective.”

Page 3:
“We look forward to receiving this information and are committed to expeditiously reviewing the new study data upon submission.”

Page 14:
“We remain committed to working with Dendreon to facilitate its activities in pursuit of licensure for Provenge. We look forward to receiving Dendreon’s amendment to its existing BLA so that we may review this information expeditiously.”

On page 13 of their response, FDA said this: “FDA shares the concerns raised by CTL regarding the need for treatment options for advanced prostate cancer. The agency has implemented programs designed to expedite the review and approval of promising new treatments for cancer and other life-threatening diseases, and continues to work to improve those programs.”

“FDA has deep sympathy for the plight of patients who have exhausted their treatment options, but Congress requires FDA to make approval decisions based solely upon scientific data.”

CareToLive tried to get Congress to investigate the shenanigans surrounding the FDA’s handling of the original Provenge BLA. All Congress had to do was drag Matt Herper from Forbes into the chambers and ask him about this:

“But right now, its stock is dangerous to buy, because its fate will be determined by unpredictable politics at the Food and Drug Administration, not the certainties of science.”

http://www.forbes.com/2007/04/20/prostate-dendreon-stock-biz-cx_mh_0420dendreon.html

In addition, Congress could have called in Allison Martin from NCI as she helped write one of the leaked letters, or Richard Pazdur, who was seen passing notes at the Advisory Committee hearing and was said to be ready to throw a tizzy fit if Provenge was approved back in May 2007.

Congress could have called in Howard Scher who was worried about Dendreon investors and competitive Phase II trials for treatments he was working on, investing in and advising others to invest in.

Congress should still investigate this travesty. Here is some more information that can put them on the right track:

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

CTL expects FDA to right most of this by Christmas Day, 2009.

Hey FDA, get Provenge to the dying men! Right away! Right now!

Popularity: 35%

CareToLive attorney, Kerry M. Donahue, filed a motion on Monday, October 26, 2009, in the Sixth Circuit Court of the United States, asking the Court to allow leave to supplement the FOIA appeal record with previous documents, numbers 3, 20 and 29 from Southern District of Ohio case no. 07-729 CareToLive vs. von Eschenbach.

CareToLive was concerned about the possible destruction of documents by FDA employee Richard Pazdur so we filed a motion to preserve documents (document 3). Upon Pazdur’s discovery that the documents were being sought, he deleted the documents.

The Court denied that motion but verbally instructed FDA counsel to instruct its clients not to destroy any documents involved in pending litigation. Well that client did indeed destroy the documents and the lower Court denied the request by Appellant to obtain the date of the computer deletion of the records by the FDA.

Richard Pazdur of the FDA possessed said documents, both hard copies and electronically on his FDA computer. The affidavit from Richard Pazdur further indicates that the documents are now unavailable because the electronic copies were deleted and the hard copies were shredded, by him.

Kerry also writes in the motion for CareToLive, available here Motion To Supplement, that despite the lack of any reasonable search for the documents by Appellee and despite the lower Courts repeated refusal to allow discovery on the issue and without the lower Court even allowing Appellant the full opportunity to be heard, the District Court denied the Civil Rule 56(f) motion of Appellant and declined to allow even minimal discovery and a full response to Defendant-Appellee’s motion for Summary Judgment, which would have been appropriate based on the particular facts of this case.

These three documents, numbers 3, 20 and 29, are very important to the brief and oral arguments to be presented to this Court. Let’s hope the Sixth Circuit Court agrees and we can get to the real reason why Richard Pazdur stopped a safe, non-toxic treatment that extends survival from reaching men who were dying and had no other treatment options. Check back here as we will report on this case as it moves through the Court of Appeals.

Popularity: 36%

The NY Times just released an article showing what a great guy Richard Pazdur is. This caused me to revisit journalistic integrity. The reason I did that is because I am going to present some rather harsh information about Richard Pazdur that this NY Times reporter, Gardiner Harris, refused to address. It appears to me that this reporter is a friend of Pazdur and this precludes him from maintaining journalistic integrity. This NY Times reporter will insult patient advocates while standing up for a guy who is supposed to be the ultimate patient advocate, a doctor.

http://www.nytimes.com/2009/09/16/health/policy/16cancer.html?_r=1

The preamble for The Society of Professional Journalists states:

Members of the Society of Professional Journalists believe that public enlightenment is the forerunner of justice and the foundation of democracy. The duty of the journalist is to further those ends by seeking truth and providing a fair and comprehensive account of events and issues. Conscientious journalists from all media and specialties strive to serve the public with thoroughness and honesty.

Please note: Conscientious journalists from all media and specialties strive to serve the public with thoroughness and honesty. It does not say to serve government employees and, in particular, doctors who work for the FDA, a government agency.

On its website, the New York Time states:

For more than a century The New York Times Company has stood for quality, integrity and distinguished journalism.

Will it remain standing for quality, integrity and distinguished journalism? The NY Times says readers dissatisfied with a response or concerned about the paper’s journalistic integrity may reach the public editor at public@nytimes.com or (212) 556-7652.

As you read the article penned in favor of Richard Pazdur, while denouncing those who protested against him, notice what is left out rather than what is puffed in. Why didn’t Gardiner mention Provenge or ImClone, two big blemishes on Richard Pazdur’s resume? Richard Pazdur is a conflicted liar. We the people should not have to see our tax dollars go to such a manipulator who pretends to be a doctor. He wouldn’t know the Hippocratic Oath if you smacked him over the head with it.

A good way to test the character of a doctor is to watch how he or she reacts in an emergency room. People are rushed to emergency room for many life threatening problems. The good doctors and nurses spring into action trying everything they can to save a life. Richard Pazdur does not react that way. In 2002, he leaked inside FDA information, which Gardiner is correct to point out is against the law, to a powerful Bristol-Myers Squibb lobbyist so he could get it into the hands of Paul Goldberg, who just happens to share tables at conferences with Richard Pazdur and this NY Times reporter, Gardiner Harris. This kept an effective treatment from reaching dying patients.

In 2007, Richard Pazdur raised his ugly head again and stopped a safe and effective, non-evasive, non-toxic prostate cancer treatment called Provenge from reaching 96,000 eligible men. The men had no other option. They had a quick destiny with death. Paul Goldberg assisted Pazdur with his non-peer reviewed medical publication called the Cancer Letter. Together, they leaked three letters that were supposed to be confidential. Why didn’t Gardiner Harris include this in his article? Continue Reading IT’S ALWAYS GOOD TO HAVE FRIENDS IN THE NEWSPAPER BUSINESS »

Popularity: 36%

In Memoriam: August 24, 2009
Remembering Bruce Tower

On September 17th, 2007, I arrived at JJ Muldoon’s Pub in Gaithersburg Maryland around 9 PM. Before too long, I heard the thunderous voice of a distinguished looking gentleman. He was being escorted to a mini-van by a woman whom I found out was one of our heroines, Melody Davis. Many around them were making a fuss. As the word spread the atmosphere became electrifying. It’s when we all realized who this man was.

Bruce, suffering from late stage prostate cancer, was not in the best physical condition, but he nonetheless made the trip to Maryland to help us protest the next day outside the FDA Headquarters in Rockville. His gut-wrenching speech captured the audience and delivered the message. Many men, like him, need Provenge NOW. They could be strengthening their immune system, fighting the awful disease we know as prostate cancer.

On a Sunday afternoon in April 2008, I spoke to Bruce on the phone. We chatted a bit and then we discussed our fight for Provenge. It was almost a year now and he was willing to keep fighting right along with us. He gave us permission to use his picture and he wrote a letter which we published as an ad in the Rockville Gazette. It is a sad statement to say we had to pay a lot of money to get the story in the local newspaper in the hometown of the FDA. Several times he appeared on the Andrew Schorr Patient Power radio show with us. He and his wife Carol were there whenever we needed their help.

(click to enlarge)

Week 2 Ad Color caretoliverockvillegazette2ad.pdf

http://caretolive.com/2008-04-09/caretolive-continues-its-in-your-face-ad-campaign-asking-the-fda-to-approve-provenge-for-prostate-cancer-now/

In his letter, Bruce made a simple plea. “Here is my plea; FDA: Please approve Provenge NOW.”

He could have had it working in his body for over two years. Now he will never get the chance to try Provenge to fight for his life.

I can hardly type this now because I just learned we lost Bruce Tower. The emotions run strong. Sadness for Bruce’s family. Anger for the FDA playing the wrong kind of god and withholding a safe and effective treatment. From everything I learned about Bruce, he was a remarkable man, dedicated to his wife, children and grandchildren. He inspired and taught other kids as a soccer coach. He led by example. He was a fine citizen indeed.

From everything I learned about our modern day government, these self-serving fools in charge could basically not give a damn. They are out of touch. They lost control. They are driving a long train full of people to their death tricking them into thinking they are going over a bridge. I can tell you with certainty, there is no bridge.

The empty promises of Andrew von Eschenbach and the nerve of him, makes my blood run cold with contempt. To me, he is the epitome of the captured FDA as declared by Harry Markopolis. To me, he let his friendship with convicted felon Michael Milken ruin his objective mission to serve the American people. Von Eschenbach double-dipped with the FDA and NCI leadership. He already set the Conflict of Interest stage. How could he keep an eye on it when he was wallowing in it?

Poor Bruce and his family. They should have had better. Their goverment let them down. They paid their taxes for nothing, not to mention the pain Bruce endured in his final days. I heard Bruce handled it like the champion he is. He only wanted to see those around him smile and live the good life.

May God richly reward you, Bruce. You should hear those words of old, “Well done my good and faithful servant.” May God comfort your family. May you rest in peace.

Popularity: 41%

What made me sickest over the Larry King show on prostate cancer was in the beginning of the show, when Larry King stated something along the lines that if they find the cure for prostate cancer they just might have to name it or call it the Milken cure. That set the tone for the show and the angle he was playing.

Larry King lost most of his fortune not too many years ago flipping insurance policy’s under the advice of some scammers. It worked well until he found out he was the mark. To recover, it looks like he went with Madoff, where he was once again taken to the cleaners. In Milken he finally found someone with juice. The show was packed with the mutual admiration society. Milken is doing his image rehabilitation desperately seeking a pardon. Maybe Larry will have Kerry on next (I can dream).

Larry King, Mike Milken, John McEnroe, Colin Powell, Joe Torre, Rudolph Guiliani, a cast of big mouths with not one word to say about Provenge. They are a sickening, pathetic bunch. We know Larry knows about Provenge because many of our friends and members reached out to Larry in the past and more recently before the show. Now if I were a conspiracy theorist…

They never mentioned Provenge, a non toxic, non invasive safe and effective immunotherapy that harnesses and enhances your own healthy cells to fight your own prostate cancer cells. Some men with late stage pc are living 8 years later. 1 in 6 men will get prostate cancer in their lifetime.

Provenge should be on the market by next year, in spite of Milken. His chairman, Howard Scher of the Prostate Cancer Foundation Therapeutic Consortium, and Milken’s recently departed CEO, Alison Martin of the Melanoma Research Alliance, colluded on the leaked letters that stopped Provenge dead in its tracks from reaching the 69,000+ men who have died since May 2007.

Mark Mitchell of Deep Capture recently published an exposé about Milken’s part in the death of 60,000 men and the delay of Provenge. The complete story of Dendreon is now available  21 August 2009
Read the full story

The PCF is also trying to take credit for financing Provenge? It stated this because it sent some money to the University of San Francisco back in the year 2000 for Eric Small to work on immunotherapy. In 2006 Small wrote a rather positive article stating Provenge may work. In 2007 Howie Scher and Alison Martin used that 2006 abstract against Provenge highlighting the word “may” as to say it may not work. PCF cannot take credit here. It can take credit for two of its big shots stopping Provenge which had positive Phase III trials under its belt while Asentar, Abiraterone and GVAX, treatments the PCF touted, were only finished with Phase II trials.

Furthermore, in the 2005 PCF Annual Report, Novacea and Cougar did not give any money to PCF. Dendreon donated between $25k to $50K. Cell Genesis gave between $10K to $25K.

Not only did the PCF do nothing to push for Provenge approval, they actually accepted money from Dendreon to support the PCF. It should have been the other way around. Dendreon was struggling for every dollar it could muster, and must have felt it had to make a donation to PCF too! Something stinks in the world of Milken’s philanthropy and I can smell it all the way in New Jersey.

Continue Reading Hey Larry King! Do your homework!! »

Popularity: 38%

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 »

Popularity: 39%

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/

Popularity: 45%

The Department of Justice (DOJ) submitted a brief on behalf of the FDA, in opposition to CTL’s Motion to conduct discovery (see second link)

You can read their entire brief here >> fdafoiamotion-memocontra-0613.pdf

* * * * *

CareToLive does not agree, and our attorney, Kerry Donahue, will be filing a response.

* * * * *

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

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

 * * * * *

Here are the FOIA Documents we received from CDER, requested by us almost 2 years ago in August of 2007, requesting FDA correspondence with Richard Pazdur concerning the Provenge delay of approval.

Freedom of Information reveals Dr. Pazdur searched both his paper and computer files and could not locate any documents responsive to plaintiff’s request.

Received 5/18/2009 Freedom of Information Act (FOIA) documents

Declaration of Richard Pazdur >> ctlpoaz29exbd-5.pdf

Defendant FDA’s Motion for Summary Judgment >> ctlsj29-1a.pdf

Declaration of Fredrick J. Sadler >> exba.pdf

Declaration of Nancy B. Sager >> ctlexhibitc3.pdf

Declaration of Beth Brockner-Ryan >> ctlryanexhibitb.pdf

From FDA, affidavit from Dr. Pazdur (above):
See id. at ¶ 6. Dr. Pazdur recalls receiving both hard
copies and electronic copies of the letters from Drs. Hussain and Scher in April 2007. See id. at  ¶ 7. However, as these letters related to a specific regulatory application conducted by a  different FDA Center (CBER), did not fall under his direct regulatory supervision, and did not  require a response from him, Dr. Pazdur shredded the hard copies of these letters and deleted any  electronic copies. See id. The documents were shredded and deleted within a month of receipt.  See id. In fact, Dr. Pazdur does not keep personal copies of any regulatory communications.  See id. at ¶ 8. Official copies of regulatory correspondence are kept in the official regulatory  document room of the specific center assigned to an application. Id.  Contrary to plaintiff’s suspicions, Dr. Pazdur never disclosed Dr. Scher’s or Dr.  Hussain’s letters to “any individuals outside of the FDA, or any media outlet, including a  publication called ‘The Cancer Letter.’” See id. at ¶ 9. In addition, he did not write any portion  of the letters that Drs. Scher, Hussain, or Fleming sent to the FDA. See id. at ¶ 10. He also never received a copy of a letter from Dr. Thomas Fleming to the FDA regarding Provenge. See id. at ¶ 11.

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It took the FDA 2 years to deny the CareToLive Citizen’s Petition.

FDA’s Response to CareToLIve Citizens’ Petition >>  fda-response-to-citizens-petition.pdf

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