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: 32%

The Department of Justice (DOJ) submitted a brief on behalf of the FDA, in opposition to CTL’s Motion to conduct discovery (see second link)

You can read their entire brief here >> fdafoiamotion-memocontra-0613.pdf

* * * * *

CareToLive does not agree, and our attorney, Kerry Donahue, will be filing a response.

* * * * *

CareToLive MOTION FOR LEAVE TO CONDUCT/COMPLETE DISCOVERY UNDER CIVIL RULE 56(f)
AND PARTIAL MEMORANDUM CONTRA TO DEFENDANT FDA’S MOTION FOR SUMMARY JUDGMENT

Link to Motion >> ctlfoiaresponse6-06-09c.pdf

 * * * * *

Here are the FOIA Documents we received from CDER, requested by us almost 2 years ago in August of 2007, requesting FDA correspondence with Richard Pazdur concerning the Provenge delay of approval.

Freedom of Information reveals Dr. Pazdur searched both his paper and computer files and could not locate any documents responsive to plaintiff’s request.

Received 5/18/2009 Freedom of Information Act (FOIA) documents

Declaration of Richard Pazdur >> ctlpoaz29exbd-5.pdf

Defendant FDA’s Motion for Summary Judgment >> ctlsj29-1a.pdf

Declaration of Fredrick J. Sadler >> exba.pdf

Declaration of Nancy B. Sager >> ctlexhibitc3.pdf

Declaration of Beth Brockner-Ryan >> ctlryanexhibitb.pdf

From FDA, affidavit from Dr. Pazdur (above):
See id. at ¶ 6. Dr. Pazdur recalls receiving both hard
copies and electronic copies of the letters from Drs. Hussain and Scher in April 2007. See id. at  ¶ 7. However, as these letters related to a specific regulatory application conducted by a  different FDA Center (CBER), did not fall under his direct regulatory supervision, and did not  require a response from him, Dr. Pazdur shredded the hard copies of these letters and deleted any  electronic copies. See id. The documents were shredded and deleted within a month of receipt.  See id. In fact, Dr. Pazdur does not keep personal copies of any regulatory communications.  See id. at ¶ 8. Official copies of regulatory correspondence are kept in the official regulatory  document room of the specific center assigned to an application. Id.  Contrary to plaintiff’s suspicions, Dr. Pazdur never disclosed Dr. Scher’s or Dr.  Hussain’s letters to “any individuals outside of the FDA, or any media outlet, including a  publication called ‘The Cancer Letter.’” See id. at ¶ 9. In addition, he did not write any portion  of the letters that Drs. Scher, Hussain, or Fleming sent to the FDA. See id. at ¶ 10. He also never received a copy of a letter from Dr. Thomas Fleming to the FDA regarding Provenge. See id. at ¶ 11.

* * * * *

It took the FDA 2 years to deny the CareToLive Citizen’s Petition.

FDA’s Response to CareToLIve Citizens’ Petition >>  fda-response-to-citizens-petition.pdf

Popularity: 41%

The FDA blew a golden opportunity.

It took them 2 years of foot dragging to reach their decision on our CareToLive Citizens’ Petition.

They DENIED it!

The only redeeming factor in their pages of excuses, is that the FDA stated 3 times that they will process the amended Dendreon BLA expeditiously.

We at CTL feel the FDA lacks the compassion and the scientific ability to evaluate our Petition.

With the stellar Provenge survival data recently exhibited, we believe the FDA should have immediately reconsidered their death rattle.

Apr 28, 2009
Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men with Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study (LINK)

The dysfunctional, omnipotent FDA has spoken loudly and clearly to the men with late stage prostate cancer who are out of options.

You can’t have a safe and effective immunotherapy yet.

Go home and die!

You can read the FDA’s response here >> fda-response-to-citizens-petition.pdf

Here are some of our thoughts on the FDA response. We welcome your comments.

Before addressing the specific requests in your petition, we first want to make it clear that we share your concern for men suffering from advanced prostate cancer.

Too many men continue dying a painful death while the FDA continues to stonewall the approval of Provenge by not addressing the deception that took place during the Provenge approval process.

We are committed to expeditiously reviewing the new information as soon as it is submitted.

This was the only good thing we read in their response.

PLEASE HURRY.

THIS IS AN EMERGENCY!

FDA shares the goal of approving new products, such as Provenge, as soon as they are shown to be safe and effective.

Provenge has shown all along that it is safe and effective. The Advisory Committee questions are regulatory questions.

Is it safe?

Is there substantial evidence of efficacy?

The panel voted overwhelmingly that it is safe and effective.

The FDA response tried to gloss over the conspiracy and conflict-of-interest issues, simply denying them without offering any evidence.

The agency lied when it said Provenge didn’t slow progression in either 9901 or 9902A. The correct terminology would have been “did not slow progression with statistical significance.”

We think that 11.7 weeks vs. 10.0 weeks in the 9901 trial is evidence of slowed progression.

A p value of 0.052 (Journal of Clinical Oncology number) or 0.085 (FDA number) should not be taken lightly, even if it did barely miss statistical significance.

Combine that with the survival p value of 0.01, and that’s pretty convincing evidence that 9901 was a successful trial.

It is a lie that Provenge did not slow progression in 9901, and it is a lie that there is no positive correlation between progression (91.5-94.8%) and survival (99.0%). The FDA’s progression argument is a LIE.

FDA has a long history of permitting access to investigational drugs to treat serious and immediately life-threatening diseases without adequate available therapies. Individuals can obtain access by enrolling in on-going clinical investigations of such products, including any existing expanded access protocols.

Continue Reading FDA LIES & DENIES — CARE TO LIVE CRIES »

Popularity: 40%

CareToLive has just learned Alison Martin no longer works at NCI. Remember her? She helped Howie Scher write his leaked letter. She now works for the Melanoma Research Alliance. Check out their website. It will be fully up and running on August 19th.

http://www.melanomaresearchalliance.org/

This is a new organization found under the auspices (patronage; support; sponsorship) of the Michael Milken Institute. It intends to support ambitious and innovative projects from both individual scientists and research teams to develop novel diagnostic and therapeutic avenues relevant to pathways governing the behavior and clinical outcome of melanoma.

Skin cancer represents the most commonly diagnosed malignancy, surpassing lung, breast, colorectal and prostate cancer.
Melanoma is a type of skin cancer.
Even though it is rare, malignant melanoma is responsible for 75 % of all skin cancer related death cases

Meanwhile, back at the NCI ranch, we tried to pursue the missing gaps in the FOIA documents, namely, Scher’s “personal” e-mail. Under the rules, we can’t have his personal letter if it has his mother’s maiden name, his social security number, his phone number, home address, etc. Well what we learned is, this e-mail has his personal opinion. Did he say bad things about the Advisory Committee, its panelists, the patients who made public statements, CBER, Dendreon and Provenge? Did he brag how Asentar and GVAX and Abiraterone are better options? We want to know. Personal information and personal opinion are two different things, especially when that opinion influences a decision.

You can view the NCI FOIA documents here:

http://caretolive.com/NCI-FOIA-Response.pdf

Well, NCI tells us that since Alison Martin no longer works there, and since Scher doesn’t work for NCI, they do not have to turn over the e-mail. Can you believe that? What Alison Martin did when she worked for NCI should be fair game. Our tax dollars paid for that “work”. And what Scher, the most conflicted doctor on the Advisory Committee panel, had to say is most relevant in why he fought so hard to stop Provenge from being approved. We are sure he didn’t ask Alison Martin her bra size because it appears she forwarded the e-mails to Howard Streicher. We will continue to pursue this.

Popularity: 63%

CareToLive has received an answer from the FDA to our Complaint that the FDA has not been forthcoming with all of the Freedom of Information (FOI) documents that we requested and are entitled to under the Freedom of Information Act (FOIA). Our Attorney Kerry Donahue will attend a Pretrial Hearing on March 5, 2008.

CareToLive requested all documents, letters, emails and /or correspondence from the National Cancer Institute (NCI) to the FDA or those acting as advisors to the FDA, concerning the BLA filed by Dendreon Corporation for fast track appproval of Sipuleucel-T, known under its marketing name of Provenge between January 1, 2007 and May 30, 2007. We seek to understand the role that the NCI played with regards to the process that resulted in the non approval of Provenge on May 9, 2007. We also requested all information pertaining to the roles played by Dr. Scher, Dr. Hussain and Dr. Fleming including Alison Martin and anyone else at NCI in regards to the FDA decision or with those working with the FDA, as as Scher, Hussain and Fleming.

CareToLive also requested all letters written to the FDA or prepared by the FDA and purported to be from Dr. Scher, Dr. Hussain and Doctor Fleming between March 29, 2007 and April 30, 2oo7 regarding the BLA submitted for Provenge, including the envelope or other means of communication whereby the FDA received such letters and a copy af any record for those letters then being disclosed to any media or other persons or specifically a publication call “The Cancer Letter”, including the means of communication of the Cancer Letter of the Scher, Hussain and Fleming letter from the FDA or its employees to outside persons, publications or companies. Continue Reading FDA Responds to CareToLive Complaint for Violation of Freedom of Information Act »

Popularity: 43%

On a night in early April, 2007, the temperature was hanging around 35 degrees outside. It was considered good sleeping weather on the East Coast. But a particular doctor could not sleep. He tossed. He turned. His mind was still rapidly busy with the activities from a few days ago.

He could still see his fellow panelists sitting around the table in that hotel room in Gaithersburg, Maryland. He tried his best to influence them, to show them the flaws in the medical treatment they were evaluating. He kept pointing them to trial design problems, failed endpoints, and survival that surely could not have come from the agent.

Then the doctor’s gut suddenly felt that guilt-wrenching churn. Novacea and ProQuest had just popped into his head. If those panelists persuade the FDA to approve Provenge, he is finished. “Oh, no,” he thought, “and Schering-Plough will back out of that deal. I have to do something.”

Dr. Howard Scher sprang out of bed and headed to another room.

Continue Reading Sleepless in Asentar »

Popularity: 99%