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.

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