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%

This letter was delivered by Fed Ex to our Attorney, Kerry Donahue, today, 01-11-10, at around 1 PM.

Download the letter here >>  cberletterofresponsetocaretolive.pdf

(Click on to enlarge)

Popularity: 12%

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: 12%

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: 14%

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!

Popularity: 22%

While Provenge (Sipuleucel-T) is not yet FDA approved, it may be available in a new Dendreon-sponsored multicenter, open label (no placebo), phase 2 study for men with metastatic castrate-resistant prostate cancer, if a man fits the eligibility requirements. (Note: This trial is different from the previous ProACT trial, which used lower concentrations of Sipuleucel-T, and required that men live close to the trial site). The trial is also available to those men who received placebo during the previous trial.

Some basic criteria (see link below for the full list) for being considered include having:

Metastatic disease
Castrate-resistant prostate cancer (this means men who no longer respond to surgical or medical castration, such as hormone therapy)

PSA of at least 5.0 ng/mL
(* NOTE - watch for this criteria to change in a few days. )
watch at http://www.clinicaltrials.gov/ct2/show/NCT00901342?term=provenge&recr=Open&rank=2

Castrate level of testosterone (less than 50 ng/dL) achieved via medical or surgical castration
Life expectancy of at least 3 months
Adequate hematologic, renal and liver function
No lung, liver, or brain metastases

It must also be at least 28 days since a man has: used systemic corticosteroids (use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, less than or equal to 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans); used non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide); had external beam radiation therapy or major surgery requiring general anesthetic; had any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace), diethylstilbestrol (DES), and ketoconazole; received chemotherapy; or had treatment with any other investigational product.

Current trial sites include Park Ridge, Illinois; Greenbelt, Maryland; Durham, North Carolina; Norfolk, Virginia; New York, New York; and Seattle, Washington. Men must contact the trial site they are interested in to find out if they meet all the criteria. To learn more, including the phone numbers of the trial sites, click here>>

Link to Trial:  http://www.clinicaltrials.gov/ct2/show/NCT00901342?term=provenge&recr=Open&rank=2Video re: Provenge - http://activation.dendreon.com

Popularity: 24%

November 23, 2009

SENT BY FACSIMILE AND U.S. MAIL

Citizen Petition -2007-P-168

Karen Midthun, MD
Acting Director of CBER
Food and Drug Administration
1401 Rockville Pike
200N
Rockville, MD 20852

Dear Karen Midthun, MD ,

I am representing and speaking for an advocacy group by the name of CareToLive. The group CareToLive filed a Citizen Petition with the CBER division of the FDA on July 26, 2007. That Petition asked for a reconsideration of the May 2007 denial of a license for distribution of Provenge, made by Dendreon Corporation. Provenge is a treatment for late stage prostate cancer, which is a patient class without appealing treatment options.

While your office denied that petition in early 2009 you did indicate that when your office did obtain the remaining data requested from Dendreon (the results of the IMPACT trial), that, as stated several times in your Petition response, CBER would expeditiously review that data.

The last line of the CBER response said:
“We look forward to receiving Dendreon’s amendment to its existing BLA so that we may review this information expeditiously.”

While we were disappointed that CBER did not end the IMPACT trial based on the interim data provided by the Independent Data Monitoring Company (IDMC) that CBER was presented with in mid 2008, as that was clearly additional confirmation that Provenge was safe and effective, so that the patients who are in great need could have started receiving Provenge much sooner, we remain hopeful of expeditious review now that the trial was completed and you have all the data.

Now, 2 ½ years after the original AC panel of experts voted to approve Provenge you have been provided a response by Dendreon to your then issued CR letter. You now have all the new data requested as of October 30, 2009 which was the day Dendreon completed its rolling aBLA submission.

We are writing you this letter to remind you of the promises made in your response to the CareToLive Citizen Petition to review the data expeditiously. Please devote whatever resources you can to this evaluation so that it can be timely completed. Remember that this is no ordinary application; rather it is an application for approval of a treatment for end stage prostate cancer for which viable treatment options do not exist.

We at CareToLive get e-mails and letters from patients and their families every week who desperately want Provenge for themselves or their loved ones. Some of the stories we hear are heartbreaking. Having Provenge approved by Christmas of 2009 would provide much hope and joy to these patients and their families at a time of year when joy is needed. Recently we lost one of our advocates, Bruce Tower to late stage prostate cancer. Mr. Tower got a placebo in the IMPACT trial. We understand that at the beginning not everyone that wants Provenge will be able to get it, but we have to start somewhere. Approval by Christmas would be an act worthy of much praise and many advocates including CareToLive will praise such effort as we understand you would need to work diligently for such an extraordinary and very humane effort to occur.

If you think the timetable for approval of Provenge by Christmas is impossible, then please explain why it is impossible so that we can try to understand. While I know you are extremely busy folks there, this is a treatment for which the original BLA was filed (and voted to be approved by experts soon thereafter) in November 2006.

If expeditious review is something that you no longer think your division is capable of, then we would like to meet with you to discuss it. We will come to Rockville for such a meeting (or anywhere else you like). We would like the meeting to be held one or two weeks after Christmas, if you are available. We would like to bring several board members from CareToLive as well as about 5 other prostate cancer advocates including Thomas Farrington (PHEN).

If approval can be completed expeditiously there is probably little reason for the post Christmas meeting to occur. If that approval is impossible within that time and you do not estimate approval in the days or week thereafter then these advocates would very much like to meet with you so as to discuss the issues involved with the inability to move expeditiously as promised in your Citizen Petition response, on the amended BLA for Provenge.

Thank you very much for your time and consideration of this matter.

Sincerely,

Kerry Donahue

Popularity: 26%

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%