March 11, 2010

Dr. Sharfstein,

Can you please check with CBER and see why it is taking them so long to make a final decision on Dendreon’s Provenge.

The pending BLA is an amended BLA that was first submitted to the FDA in 2006. Following a March 2007 AC, in which the FDA hand picked experts overwhelmingly voted for approval, CBER decided to require additional proof of efficacy. That additional proof, as set forth in the SPA, was in fact obtained by Dendreon with results being announced in April 2009 (interim data was also positive and the IDMC also recommended approval in October 2008).

Now CBER has had all the new clinical data from the IMPACT trial as of July 2009 and all the CMC data since October 2009. Despite promises from CBER to the advocacy group CareToLive and others that they would review this treatment, intended for late stage prostate cancer, expeditiously, the treatment inexplicably remains unavailable.

This review is hardly being done expeditiously. FDA has now delayed this treatment from reaching patients for 3 years.

Please inquire/help.

Kerry M. Donahue, Esq.

Counsel for CareToLive

Dublin, Ohio

CTL Petition for reconsideration of May 2007 decision to issue CR filed in July 2007.

Popularity: 2%

John Stossel from the Fox Business Network asks this very important question. Next he asks “Who owns your body?” You can watch his documentary as he weighs in on whether the government should have control over our bodies and the medications we take.

http://video.foxbusiness.com/v/4056081/who-owns-your-body/?playlist_id=87050

This touches all of us at CareToLive since we have been fighting the FDA for three years now for Provenge access for late stage prostate cancer patients. Stossel includes footage from the FDA Rally we held in Rockville, Maryland on September 18, 2007, with myself included at the Rockville Rally.

Stossel uses video of our beloved Bruce Tower. Bruce died while waiting for the FDA to approve Provenge, never having been able to receive it himself. He did participate in the Dendreon Trials, but he unfortunately only received a placebo, and not the actual immunotherapy.

The memory of Bruce, along with other CTL members, Stephen Study, John Fish, Howard Cassell, and Richard Ripp, makes us want to shout right along with John Stossel when he tells the FDA, “Why don’t you just butt out?”

The FDA can say it makes its decision based on science but we know that is all a bunch of baloney. Even Forbes writer, Matthew Herper, can tell you that. Remember this quote from his article back in April 2007:

Provenge’s fate “will be determined by unpredictable politics at the Food and Drug Administration, not the certainties of science.”

And then there was the testimony by Harry Markopolos before Congress during the Bernie Madoff investigation:

Congressman: Are you familiar with the concept of capture when you are talking about regulation? What is that? Do you know that concept?

Harry Markopolos: Yes. It’s basically when the regulator is in bed with the industry they purport to regulate and do not regulate the industry. In fact, they consider the industry the client, not the public citizens.

Congressman: And have you seen that in action.

Harry Markopolos: Yes. At the Food and Drug Administration and at the SEC.

Excerpt starts at 14:14  http://www.cnbc.com/id/15840232?video=1021435842

Care To Live is glad to hear Harry Markopolos has written a book called “No One Would Listen”  due out March 2nd.

In the meantime, check out John Stossel’s report and then write to your Senators and Congressmen and tell them to tell the FDA to butt out!

Hey, FDA, approve Provenge NOW!

Popularity: 7%

CareToLive Attorney Kerry M. Donahue’s Representative (12th District of Ohio) Patrick J. Tiberi has made his office available to assist us in looking into the delay of Provenge and made a Congressional inquiry of the FDA.

Popularity: 10%

   On January 28, 2010 the Florida Bar recognized Kerry M. Donahue, CareToLive’s attorney extraordinaire, for his stellar pro bono efforts on behalf of prostate cancer patients.

“The Food and Drug Administration has lost its way”, said Mr. Donahue. “The FDA Advisory Committee advised the FDA to approve Provenge, a safe, effective, non-toxic immunotherapy for men with late stage prostate cancer, and then the FDA delayed it without a rational explanation.”

Kerry sprung into action. He wrote dozens of motions and briefs, spending hundreds of hours trying to right the wrong. Without his efforts, we at CareToLive believe that the FDA would have deferred to the chemo cartel, who never wanted Provenge to see the light of day. He brought enough exposure, to insure that Provenge gets a fair chance for licensure this time around.

The FDA knew the patients were staring death in the face since they granted Dendreon’s Provenge Fast Track Status and Priority Review. It then chose to ignore its handpicked Advisory Committee which voted Provenge safe by a vote of 17-0 and substantial evidence of efficacy, by a vote of 13-4.

Kerry was honored by the President of the Florida Bar, Jesse H. Diner, & the Chief Justice of the Supreme Court of Florida, Peggy A. Quince.

Recently the Acting Director of CBER, Karen Midthun, denied Kerry’s request for a meeting. Ms. Midthun said the reason was as follows: “However, FDA cannot discuss matters with respect to a pending BLA without the express authorization of the sponsor. Therefore, at this time, we respectfully decline your request for a meeting.”

This statement flies in the face of the fact that FDA leaked letters written by Howard Scher, Maha Hussain, and Thomas Fleming all of which were discussing “matters with respect to a pending BLA” which were released “without the express authorization of the sponsor.” FDA picks and chooses when it will violate its own regulations, in order to help its business and political relationships.

At the center of this case is Howard Scher, a SGE for FDA, who was leading trials for treatments in competition with Provenge at the time he sat on the Provenge Advisory Committee. One day later he started working on a letter with the help of NCI’s Alison Martin for the sole purpose of lobbying the FDA to stop Provenge. Scher knew the Advisory Committee vote was a problem for his competing trials, one of which NCI funded, so he sprang into action right away. CTL has documented Mr. Scher’s activities and financial concerns (see Sleepless in Asentar and CTL Writes Interim FDA Commissioner Frank Torti). The astonishing fact is FDA went along and helped Scher by leaking his letter as well as follow-up letters by Hussain and Fleming, all of which discussed matters with respect to a pending BLA.

The FDA then had its legal team block all efforts by Kerry to get the men access to Provenge. Over 80,000 men have died while we waited another 2.5 years for further results. Those results are now in and they confirmed that Provenge is safe and effective. We are still waiting while they drool over the data.

In the meantime Kerry is also fighting for the Freedom of Information data to prove how flawed the process was. They are stymying us again, at every turn. He is determined to bring more oversight and transparency to an agency that has run amuck.

Congratuations to Kerry for receiving the Florida Bar President’s Pro Bono Service Award for 2010. CTL and all the friends of CTL are very proud of you. You are the best that mankind has to offer.

Popularity: 13%

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: 18%

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: 26%

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%

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: 34%

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: 33%