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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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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The CMS completely embarrassed itself yesterday!

The Center for Medicaid Services (CMS) had its long awaited MEDCAC meeting. It was designed to provide guidance to CMS as to whether they should pay for Medicare coverage for patients to receive Provenge. However, much of the meeting was spent with the CMS chairman trying to justify this futile exercise over a newly FDA approved, immunotherapy treatment already helping thousands of men with prostate cancer.

Further evidence of government incompetence was seen up close and personal. The chair of the meeting had a clear agenda. It turns out that he is on the payroll of the health insurance companies, as a consultant for them, which could easily explain his bias. Early on he allowed the speakers to express themselves, but his tone change toward the end.  His bias was revealed in his grandiose effort to paint the picture he wanted, by leading and sometimes even badgering the presenters, and interjecting his own emphasis as desired. His frequent shouting of “aha” was disgraceful.

CMS continues to refuse to provide documents to Care To Live as required under the Freedom of Information Act (FOIA), as to why this nonsense of a meeting ever came to be called in the first place. Litigation on this issue seems inevitable.

One issue clearly presented is that black men will be disproportionately unable to obtain a timely treatment that may actually have a more significant survival benefit for them. Black men are much more likely to get prostate cancer, and Provenge works even better in this population. It is a travesty that to obtain Provenge earlier, when the chances for three year survival are better, you will need either supplemental insurance or money.

The presenters at the meeting, including Dendreon, Urologic Oncologists, patients, patient advocates and concerned individuals who have followed Dendreon through its 5 year battle to bring Provenge to market, understand Provenge far better than CMS ever will.

As predicted, there will be no long term ill effects to Provenge. This government debacle was a waste of both taxpayer money, and Dendreon’s time, money and energy…which would have been better spent solving the supply problems.

In other words Provenge, will be covered by Medicare as anticipated. This very expensive exercise turned out to be a complete waste of thousands of peoples time and resources, as well as the taxpayer’s money.

Too much bad government!

This process was an ill thought out travesty by a power hungry organization. Much of the CMS meeting seemed to be an effort by the CMS chair to justify their huge waste of time and taxpayer money, which only made them look more incompetent.

It caused short term harm to Dendreon, however if we look at the bigger picture, it helped bring more attention to Provenge, and its groundbreaking immunotherapy treatment for cancer, which has now become one of the most well known cancer treatments in the world…

Now, about those supply problems…….

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A Dingell has been in the House (15^th District of Michigan) since 1930 but this Dingell should go. This Michigan race is surprisingly in play and Care To Live says, “Give Dingell the boot he deserves.”

Please remember that as head of the Energy and Commerce (E&C) Committee it was Dingell who refused to investigate the FDA delay of Provenge after as many as 16 Congressmen called for one. This was a great opportunity to help uncover the conflicts of interest that lead to the FDA’s mistaken decision to delay Provenge. As you know, since then Provenge has been approved, and demand now far exceeds supply for this important treatment for late stage prostate cancer patients.

Dingell could have helped the patients and decided not to. For his lack of caring and lack of concern for cancer patients he should be ashamed.

Many CTL supporters called and mailed Dingell. Even University of Michigan’s Dr. Mark Moyad contacted Dingell’s office. Care To Live called and mailed his office, begging for his help. PHEN’s Farrington did the same. We later held a small demonstration outside his office with the help of our Ann Arbor Friends. To no avail as the sanctimonious uncaring Washington pompous power broker snubbed us all.

Now is the time for you Michigan voters to say how displeased you are with Dingell’s refusal to investigate the unnecessary and deadly decision to delay Provenge for those three long years as friends of CTL passed away from their prostate cancer.

PLEASE pass this to your voting friends in Michigan!

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Care To Live gets contacted often when things just don’t add up. When CMS initiated an investigation into whether or not it should cover Provenge, a suspicious e-mail was blind CC’d to 500 people. Many folks wrote to CTL inquiring about it. CTL started investigating the matter.

Some of those 500 people who were CC’d on the erroneous information work on Wall Street, some work at CMS, and others work at the FDA as confirmed in the response to our Freedom of Information Act request. One person who was included was none other than Dr. Howard Scher at Memorial Sloan-Kettering, who has never been a friend of Provenge.

Here is that e-mail:

http://caretolive.com/wp-content/uploads/2010/07/anonymous-misinformation-cover-letter.pdf

And here is the bogus 27 page report (Note: this copy contains a two-page rebuttal by friends of CTL):

http://caretolive.com/wp-content/uploads/2010/07/provenge-approval-fud.pdf

A friend recently provided CTL with $500 to fund a reward for comprehensive information leading to the confirmed identification of the person, or persons, who sent the above e-mail and the 27 page report as part of an effort to disparage Provenge in the eyes of CMS as that agency prepares to review Provenge. Evidence is to be submitted to CTL Counsel Kerry Donahue at the address below, via Certified Mail. All submissions and eventual payout will be held confidential. In the case of duplicate inputs, the one with the most comprehensive suite of information and the earlier postmark will receive the reward. Only evidence submitted via Certified Mail will be considered. Be as comprehensive in the submission of information as possible to ensure full consideration of your first mailing. Also, be sure to include contact information (telephone/cellphone and address) so that Kerry can contact you, should that be necessary.

Here is the e-mail address from which the false information was sent:

From: Jonathan White <jon.white.dndn@gmail.com>
Sent: Wednesday, July 14, 2010 8:24 PM
To: scherh@mskcc.org
Subject: Provenge Safety Concerns

And here is the address to send any information via Certified Mail:

Kerry M. Donahue
Chief Counsel for CareToLive
6295 Emerald Parkway
Dublin, Ohio 43016

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Care To Live is very concerned that too many men are again unable to access Provenge. The FDA continues to take its own sweet time inspecting Dendreon’s clean rooms in order that Dendreon be able to provide Provenge to more men now. The FDA fails to recognize the importance of rearranging its priorities, along with the need for taking things out of order sometimes.

In cases such as Provenge, whereby we have an unmet demand for a treatment for late stage cancer where there are no viable alternatives, the old “first in first out”, is not reasonable nor acceptable. Humanity compels this bureaucracy to look at the bigger picture, men’s lives, and to act non-bureaucratically.

Care To Live Inquired of CBER on August 26, 2010

XXXXXXXX

Please feel free to correct us if we are wrong but we understand that Dendreon’s New Jersey Plant is waiting on FDA approval before it can begin using the additional 75% plant capacity.

We understand that you are an extremely busy agency. However, it seems that there are some things that should be given at least some priority over others.

In this case Dendreon is way short of being able to satisfy the demand/need for Provenge. That combined with the fact that Provenge is for a late stage patient population makes timely certification of this plant all the more important.

We would request that CBER make all possible effort to timely certify the plant so as to enable more prostate cancer patients to benefit from this new treatment as soon as possible.

Thank you for the consideration.

Care To Live

________________________________________________

Response on September 1, 2010

Thank you for your recent inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding Provenge. CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

While we can not discuss specific details with you regarding the Dendreon plant, we appreciate your concerns regarding the availability of Provenge and take them very seriously.  The Agency recognizes the importance of new cellular therapies like Provenge, for serious diseases for which current treatment is unsatisfactory. We will continue to work closely with the manufacturer in its efforts to make Provenge available to the public.
Sincerely,
H.A.
Consumer Safety Officer
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
__________________________________________

On October 15, 2010

XXXXXXX

The FDA has its new Fast TRACK program but there is no info there about sipuleucel-T (Provenge). Isn’t this supposed to show where the FDA is with regards to inspections?

We can’t figure out why inspection of the additional 75% of capacity of the NJ plant can’t be timely completed. This is a treatment for which demand far exceeds supply and it is for late stage prostate cancer patients.

The FDA’s Fast TRACK program is supposed to provide additional accountability and transparency on the process. Everyone should be entitled to know where the process stands at the FDA regarding this extremely important inspection. Importantly, can’t the process be given some priority considering the circumstances??

Care To Live

______________________

On October 19, 2010

Thank you for your recent inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding Provenge. CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

While we can not discuss specific details with you regarding the Dendreon plant, we appreciate your concerns regarding the availability of Provenge and take them very seriously.  The Agency recognizes the importance of new cellular therapies like Provenge, for serious diseases for which current treatment is unsatisfactory. We will continue to work closely with the manufacturer in its efforts to make Provenge available to the public.

If you have further questions regarding the availability of Provenge, you may contact the manufacturer, Dendreon Corp., directly at www.dendreon.com or 877-336-3736 regarding their product.

We hope this information is helpful.

Sincerely,
H.A.
Consumer Safety Officer
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

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CareToLive received word today from our counsel Kerry M. Donahue that the United States 6^th Circuit Court of Appeals has granted the request for oral argument in the case of CareToLive vs. FDA, Case No. 09-4084.

Oral argument will be heard by a 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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Dear Colleague (ahem),

Now for the cover letter that accompanied that spurious paper.

These anonymous dolts are truly grasping at straws, alluding to fictional dreams of bloodshed and birth defects.

We are not about harming people. Au contraire. We want people to live longer with better quality of life.

If I were to mention Thalidomide, which caused birth defects in thousands of women, in the same sentence as the safe, non toxic, non invasive immunotherapy Provenge that helps men with prostate cancer add years to their lives, I would want to remain anonymous too.

Who are these physicians and scientists in favor of suffering and death?

Okay, okay, I will shut up and present the letter.

anonymous-misinformation-cover-letter.pdf

Our previous blog covered the bogus report making the rounds, falsely disparaging Provenge. (see blog below Provenge is Approved but the Lies Continue)

This further dispels that bogus report. Care To Live has learned,

Dendritic/other immune cells are extravascular, not in the blood. Removing less than 3% of immune system. If you check 3 weeks after apheresis, level of immune cells in blood is same as prior to apheresis.

The immune cell count calculation within the report appears to be wrong. Based on the article, the calculation discussed the immunodepletion of the cells within the blood. However, the majority of immune cells are in the TISSUE, and not just in the blood. Dendreon measured the immunodepletion 3 weeks into the trial and that was normalized.

Within the clinical trials no increase in infection was seen between placebo arm and Provenge arm. This suggests a normalized immune system.

The survival in the control arm was no different than historical normals for Prostate Cancer.

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A bogus 27 page paper is being aggressively sent around wall street, and the medical, scientific regulatory and legal community, asking people to contact the FDA and the CMS. The cover letter touts the nonsense that they are scared to voice their concerns publicly. Feigning their safety fears is the same ploy they used last time, hiring bodyguards, at the taxpayers expense, fabricating non-existent threats, while no police reports ever turned up. This time we are determined to get to the bottom of it.

provenge-approval-fud.pdf

Their poor argument about the Phase III trial is dispelled here by Provenge advocate Ocyan:

This was a serious piece of work to support an argument that Dr. Hussain put up during the 2007 AC meeting when she said that the placebo protocol might have been active and could hurt patients. At that time, she gave no explanation of how that could be the case. Now, the argument is that it is immuno-depletion.

The basic idea is that a large number of immune cells were taken from a patient in a leukapheresis procedure. If a patient was on the treatment arm, he would get most of them back on reinfusion. However, if a patient was on the control arm, he only got back less than a third of what was taken during the leukapheresis procedure. Therefore, the immune system of a placebo patient was suppressed. That is called immuno-depletion.

The immuno-depletion attack on Provenge goes like this. Because of immuno-depletion, Continue Reading Provenge Is Approved But The Lies Continue »

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