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 

Popularity: 26%

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

Popularity: 28%

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: 40%

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%

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

Popularity: 46%

Seems there is no moving forward without moving backwards, as much as moving forward would be the right thing for everyone to do. The FDA won’t allow us to move forward so we must forever walk them through the sins of the past. The FDA dooms themselves to forever be walked through events of the past, events of the present, and events of the future.

While they have the power to end it happily like good old Ebenezer, and to help Tiny Tim (Teddy), they choose to let it end without redemption for themselves. Ebenezer Scrooge epitomizes the current FDA.

http://www.youtube.com/watch?v=qY2TT_aj_Fw&feature=fvsr

First, today, we visit the Provenge of May’s gone past.

As you know shortly after the FDA announced that they were not going to approve Provenge in May 2007 advocates met with then commissioner Andrew von Eschenbach to discuss the mistake the FDA had made in denying the BLA for Provenge and not allowing late stage prostate cancer patients to have Provenge.

It appeared that absent from the group of advocates at that meeting was anyone from the Prostate Cancer Foundation. However, unbeknownst to the advocates there meeting with Dr. von Eschenbach, the Prostate Cancer Foundation was in fact there. The problem was they were there on the other side.

The Prostate Cancer Foundation had and has the ear of former commissioner Andrew von Eschenbach. It is now crystal clear that if they would have gone they would have been sitting on von Eschenbach’s side of the table. Since the Commissioner has left the FDA, CareToLive has requested his help and he has declined (that request was renewed after the data came in).

The advocates at the advocacy meeting might not have seen it in Andy’s eyes but in them were, Michael Milken, Jonathan Simons and Stuart Holden all from the PCF.

They had and have the ear of Dr. von Eschenbach. What good could it do for the advocates to meet with Andy von Eschenbach when the largest prostate cancer patient advocacy group was absent and was in fact telling von Eshenbach to do the opposite that the advocates at the meeting were advocating for? Did those advocates know that they were speaking to the commissioner and the PCF? It’s kind of like the old poker adage; if you are sitting at a poker table and you don’t know who the sucker is, it’s you. The chair that spoke loudest was the chair that sat empty. When is the PCF going to pull up its chair to the right side of the table?

Thy enemy has shown thyself and that enemy is within the advocacy groups themselves. In deference to Michael’s love for baseball: Does anyone doubt that if the PCF would just step up to the plate and call for accelerated approval they could hit a home run.

In September of 2007 on behalf of CareToLive I sent a letter to Michael Milken by regular U.S. mail seeking his support for the effort to make Provenge available to late stage prostate cancer patients. That letter was never responded to.

Aren’t Mr. Milken and his groups in favor of speedier approval and access to treatments for late stage disease when the patients are without good alternatives?

Michael Milken founded the group Faster Cures which has shown no indication that it is in fact willing to support getting treatments such as Provenge to the patients faster.

Mike Milken says:

FasterCures

This Washington, D.C.-based think tank is removing barriers to progress against all life-threatening diseases.

The FasterCures team is dedicated to saving lives by saving time.
Milken Institute

Mike and his Faster Cures both remain MIA!!

More importantly, the greatest scientific achievement in late stage prostate cancer treatment in modern history and the PCF does nothing to help groups like CareToLive and others to try and speed it to the patients. If not now when? They have no right to call themselves prostate cancer patient advocates. Since the new data was announced CareToLive again sought the assistance of the multimillion dollar funded Prostate Cancer Foundation. These requests have repeatedly been made by CareToLive and they have repeatedly been ignored by the largest, most powerful and influential prostate cancer advocacy group first made in 2007 and then later made by request at the April 24th 2009 PCF round table in Washington D.C. and then later made by e-mails and finally culminating in the open letter sent by e-mail and regular U.S. mail to PCF CEO Jonathan Simons.

Soon after the advocates meeting with Dr. von Eschenbach after the Provenge denial in 2007 came this event:

Los Angeles, 2007 Milken Institute Global Conference
Building a Food and Drug Administration for the 21st Century

Moderator:
Greg Simon, President, FasterCures/The Center for Accelerating Medical Solutions

Panelists:
David Gratzer, Senior Fellow, Center for Medical Progress, Manhattan Institute
Andrew von Eschenbach, Commissioner, U.S. Food and Drug Administration

Greg Simon, President of FasterCures/The Center for Accelerating Medical Solutions and panel moderator began by asking how we can take the FDA we have today and get to the one we need for the 21st century. Andrew von Eschenbach, Commissioner of the FDA said, “in essence, the FDA is an information management business, and the world around us is changing fast and the data is changing also.” Personalized medicine will fundamentally change how the FDA approaches its work and how it is organized and the types of skill sets employees need. Dr. von Eschenbach talked about how science has crossed the threshold where diseases can be viewed through a molecular prism. “This doesn’t have to be about the science of safety or efficacy, with new molecular medicine we can have both,” he pointed out.

Balancing patient safety with access will be critical. “We have these discussions and a lot of time is spent on safety but we need to be sure we have an innovative drug market,” offered David Gratzer, Senior Fellow at the Manhattan Institute. Moving towards a “lifecycle approach” at the FDA that balances safety and access is critical and was a key message of the 2006 Institute of Medicine study on drug safety.

Beth Seidenberg, Partner at Kleiner Perkins Caufield & Byers pointed out that the future is now. Programs at the FDA like the Critical Path Initiative need even more support and resources. “We need to give the FDA the tools, people, and money to ensure the agency can take advantage of these scientific advances.” A system of integrated medical information based on electronic health records and data sharing will allow for more streamlined post-marketing surveillance and will get the FDA away from paper to electronic files. Resources and systems change are needed to advance these IT systems at the agency. “We need to get around the proprietary relationship to data and see that having access to large population data sets is the only way to advance.”

When Greg Simon asked each panelist to name the most important next step for the agency two themes emerged: getting the agency more resources and the creation of a creative strategic plan that embraces the possibility of how personalized medicine can change how we currently approve drugs.

Andy also says:
http://www.mikemilken.com/videos.taf?video=6&type=wmp

Mr. Milken and the PCF: Today there are an estimated 10 million cancer survivors just in America alone — men and women who in many cases have life expectancies measured in months, not years. “Many would gladly enlist as foot soldiers in an effort to help cure a disease that in many cases will be genetically passed on to their children and grandchildren.”

* “Cancer researchers, clinicians, and patient advocates rarely speak with one voice on any subject related to the disease. They fight over funding priorities; they squabble over treatment options; they joust over the relevance of biological discoveries. But virtually everyone agrees that Milken deserves an enormous share of the credit for the progress made against this major killer. ‘Mike’s done more for prostate cancer research than anyone in America,’ says one of the nation’s best-known prostate surgeons, Patrick Walsh, head of urology at Johns Hopkins.”
* ” ‘Michael Milken changed the culture of [medical] research,’ says Andrew von Eschenbach, director of the National Cancer Institute. ‘He created a sense of urgency that focused on results and shortened the timeline. It took a business mindset to shake things up. What he’s done is now the model.’”

* ” ‘Michael is always thinking creatively,’ says [Dr. Leroy] Hood, sounding like a convert. ‘He transformed how you do research in the field of prostate cancer and how you think about aggressively going after a disease. It has been a real revolution.’ ”

Mr. Milken, Mr. Simons we want to speak with one voice, why won’t you return our call?

Why won’t you respond to our e-mails?

Why won’t you help us to help late stage cancer patients now?

Where is the disagreement with regards to Provenge and WHY won’t you help?

So you backed the wrong horse but there is still time to change your bets, still time to turn the cart upright, still time to wipe that egg off your face and move forward.

HELP!!!!!

Here is what the PCF as a group says:

Although there has been dramatic progress in finding better treatments, the impending increase in incidence makes the need greater than ever. Fortunately, recent advances in science have made the opportunities greater than ever as well. With your support, we will be able to pursue more of these opportunities and hasten the day when prostate cancer is merely a sad memory.

Hey PCF, why won’t you give us a straight answer on our call for helping Provenge get to the patients sooner?

It’s bad enough that you have been MIA these past 2 years but now you simply have no excuse.

Teddy needs Provenge now!

Ebenezer Scrooge said of Tiny Tim, “If he is going to die he should do it and decrease the surplus population”.

I hate to be so grim on a Sunday but I have no patience for the FDA’s lack of humanity and no tolerance for the PCF’s non-support of quicker approval of Provenge because they are afraid if they do that it may bruise their ego.

Even Scher and Coffey at the PCF round table said they would rally behind Provenge if the data was there on April 28th…where is the rally?

Really, where is the rally?

Lets go!

No more free pass.

Popularity: 47%

The Citizen Petition filed with the FDA by CareToLive has now been pending for decision with the FDA for 556 days. The Petition which asked the FDA to reconsider its decision to deny a license to Provenge, was followed up by 200 positive comments in the months following that filing, by patients, families of patients, physicians, scientists, researchers and other fine citizens.

The petition process is the only formal way for patients and their advocates to ask the FDA to consider and address their wishes.

It has been 384 days since CBER head Jesse Goodman wrote to CareToLive and said that they needed some additional time to decide the petition.

It has been approximately 372 days since a CBER employee told CareToLive counsel that a committee had been formed and they were actively reviewing the petition.

It has been approximately 365 days since counsel for the CBER division of the FDA told counsel for CareToLive that they took the petition very seriously and that while she could not say who was on the committee considering the petition, she could make the assurance that they were in fact actively reviewing it.

God bless all the patients that watch and wait. Stay strong!

Kerry M. Donahue
6295 Emerald Parkway
Dublin, Ohio 43016

Popularity: 62%

On behalf of CareToLive I must share with you the news that the United States Supreme Court has denied Cert to our case, which means they have chosen not to review the matter.

Such a ruling does not mean that our arguments were without merit, it merely means the Court has determined that it is not important enough for them to spend their judicial resources on at this particular time.

It is possible we could be before the Supreme Court again in the future for several reasons:

1) None of the merits on the underlying claims made by CareToLive, including the fact that the FDA acted capriciously when they denied approval to Provenge on May 8, 2007 have been decided. Those claims will become ripe when a “final decision” is made on Provenge. The original case was dismissed without prejudice in the lower Court which means we can again file a new complaint.

2) We also currently have pending in the Southern District of Ohio the FOIA Complaint that the FDA received a stay on until May. In May the case will become active again and the Court has already ordered the FDA to produce documents.

Also remember that CareToLive still has a duly filed Citizen Petition pending at the FDA. While Jesse Goodman and Andrew von Eschenbach have chosen to ignore it to date, each new commissioner, whether interim or finally appointed, will have the opportunity to review the petition if and when it comes to their attention (if it has not already). There is new hope with each new commissioner.

Also, a friend of CaretoLive filed an appeal at HHS of the NCI decision to redact portions of the Scher e-mail received in an earlier FOIA request, which we await a decision on.

While we are upset about the loss, because the hope was to speed Provenge to the patients who so badly need it as soon as possible, we are far from being done with the ongoing fight.

While much work is done behind the scenes, please know that not a single day goes by where CareToLive members, supporters and its many friends are not taking action in some manner or another to try to speed Provenge to market so that the patients can benefit by it and the new era of immunotherapy treatments for cancer can be ushered in. This is done by continuing to spread the word among our citizens, lobbying important people in Washington within and outside of Congress, working to gain the interest of and assist media and documentary film makers as well as “educating” the FDA (new and old). The delay of Provenge has needlessly delayed the advance of science and shortened the life of many late stage cancer patients who passed without the hope that Provenge might have brought to them, but their memories live on and with us, as we continue to seek justice and reform at the FDA.

We also extend a very special thanks to those at the Abigail Alliance, Accelerate Progress, PHEN, Cancer Cure Coalition and other advocacy groups that are constantly working for the cause and share similar goals to ours.

We are not alone in this fight and continue to ask everyone reading this to continue to spread the word of Provenge. If a weekend arrives and you have not shared the story with someone during that week then write a letter, mail it and tell the story to someone else.

Popularity: 64%

CareToLive vs. FDA update
No. 08-584

Title: CareToLive, Petitioner

v.

Andrew von Eschenbach, Commissioner, Food and Drug Administration
Docketed: November 3, 2008
Lower Ct: United States Court of Appeals for the Sixth Circuit
Case Nos.: (07-4465)
Decision Date: August 28, 2008

~~~Date~~~ ~~~~~~~Proceedings and Orders~~~~~~~~~~~~~~~~~~~~~

Oct 30 2008 Petition for a writ of certiorari filed. (Response due December 3, 2008)
Dec 3 2008 Waiver of right of respondent Andrew von Eschenbach, FDA Commissioner, to respond filed.
Dec 10 2008 DISTRIBUTED for Conference of January 9, 2009.

Certiorari is granted at the court’s discretion, with most applications refused. It may be used to review the constitutional decisions of state courts of last resort and federal decisions on any important matter, especially when the inferior courts are in disagreement.

In this case the inferior courts are not in agreement on whether the finality requirement of the Administrative Procedures Act (APA) is a jurisdictional requirement. The D.C Court says “no”, the Sixth Circuit Court of Appeals says “yes”.

The Supreme Court SHOULD decide who is right, the D.C Circuit or the Sixth Circuit on the question as to whether it’s a jurisdictional issue. Since the two courts are currently in conflict it makes Federal law unclear, something the Supreme Court can remedy by reviewing the case and deciding which Court is correct.

We believe the Sixth Circuits Court of Appeals decision affirming the Southern District of Ohio decision was legally incorrect. That is the heart of the matter.

As to timing of an answer whether they will grant cert this is the Supreme Courts site statement:

“Generally, if a case is considered at a Conference, viewers can expect that the disposition of a case will be announced on an Orders List that will be released at 10:00 a.m. the following Monday.”

The Conference date is January 9th so that makes a likely decision date of January 12th.

Is the DC case on appeal to the DC Circuit? If so, is it likely that the Supreme Court will wait for that decision to see if the DC circuit resolves the conflict?

No, the cases were already appealed and they found that the finality requirement of the APA was not jurisdictional and one case said that some discovery was allowed on the issue of finality.

Check out the writ here (http://caretolive.com/CareToLiveWrit1025.pdf) as it sets forth the arguments.

The two inferior circuits are in conflict.

Continue Reading CareToLive vs. FDA Update »

Popularity: 62%

It’s the Citizens that the currently unfriendly FDA are there to serve, a fact long forgotten by the current FDA. Also, TIMELY access to innovative new treatments for patients with late stage disease where there are no good alternative treatments available, which was important enough to encompass within the revised FDA mission statement, must be a priority. That mission was not accomplished under our current FDA chief.

The next FDA commissioner needs to remember the mission of the FDA is to protect and serve the Citizens and to speed innovative, safer new treatments to them. The next commissioner should stop ignoring the pleas of the citizens! In the current FDA the Citizens have no voice and nobody at the top levels of the FDA has shown any inclination towards being caring or sensitive to patient rights.

Currently, Citizens do not have a voice in the FDA. The Citizen Petition process at the FDA is broken. The FDA is completely unresponsive to filed Petitions. The FDA’s consideration of the opinions of patient advocates, and even their own hired expert’s opinions at Advisory Committee hearings, are given mere lip service.

The public is given no rights, no voice, and no way to express its concerns to the Agency. There is very little support left for the agency in its current decayed state. Even the staunchest of supporters, such as Peter Barton Hutt, former FDA Counsel, who went before the Energy and Commerce Committee in January 2008 to ask for more funds for the agency, when current commissioner Andrew von Eschenbach would not do so,(as he was afraid to anger/upstage President Bush), now admits that the agency is broken. “This is a fundamentally broken agency,” Hutt stated earlier this year, “and it needs to be repaired.” Mr. Hutt has laid out some basic principles for sound government regulatory policy. They are:

Continue Reading THE NEXT FDA COMMISSIONER »

Popularity: 59%