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%

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: 35%

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: 39%

In Memoriam: August 24, 2009
Remembering Bruce Tower

On September 17th, 2007, I arrived at JJ Muldoon’s Pub in Gaithersburg Maryland around 9 PM. Before too long, I heard the thunderous voice of a distinguished looking gentleman. He was being escorted to a mini-van by a woman whom I found out was one of our heroines, Melody Davis. Many around them were making a fuss. As the word spread the atmosphere became electrifying. It’s when we all realized who this man was.

Bruce, suffering from late stage prostate cancer, was not in the best physical condition, but he nonetheless made the trip to Maryland to help us protest the next day outside the FDA Headquarters in Rockville. His gut-wrenching speech captured the audience and delivered the message. Many men, like him, need Provenge NOW. They could be strengthening their immune system, fighting the awful disease we know as prostate cancer.

On a Sunday afternoon in April 2008, I spoke to Bruce on the phone. We chatted a bit and then we discussed our fight for Provenge. It was almost a year now and he was willing to keep fighting right along with us. He gave us permission to use his picture and he wrote a letter which we published as an ad in the Rockville Gazette. It is a sad statement to say we had to pay a lot of money to get the story in the local newspaper in the hometown of the FDA. Several times he appeared on the Andrew Schorr Patient Power radio show with us. He and his wife Carol were there whenever we needed their help.

(click to enlarge)

Week 2 Ad Color caretoliverockvillegazette2ad.pdf

http://caretolive.com/2008-04-09/caretolive-continues-its-in-your-face-ad-campaign-asking-the-fda-to-approve-provenge-for-prostate-cancer-now/

In his letter, Bruce made a simple plea. “Here is my plea; FDA: Please approve Provenge NOW.”

He could have had it working in his body for over two years. Now he will never get the chance to try Provenge to fight for his life.

I can hardly type this now because I just learned we lost Bruce Tower. The emotions run strong. Sadness for Bruce’s family. Anger for the FDA playing the wrong kind of god and withholding a safe and effective treatment. From everything I learned about Bruce, he was a remarkable man, dedicated to his wife, children and grandchildren. He inspired and taught other kids as a soccer coach. He led by example. He was a fine citizen indeed.

From everything I learned about our modern day government, these self-serving fools in charge could basically not give a damn. They are out of touch. They lost control. They are driving a long train full of people to their death tricking them into thinking they are going over a bridge. I can tell you with certainty, there is no bridge.

The empty promises of Andrew von Eschenbach and the nerve of him, makes my blood run cold with contempt. To me, he is the epitome of the captured FDA as declared by Harry Markopolis. To me, he let his friendship with convicted felon Michael Milken ruin his objective mission to serve the American people. Von Eschenbach double-dipped with the FDA and NCI leadership. He already set the Conflict of Interest stage. How could he keep an eye on it when he was wallowing in it?

Poor Bruce and his family. They should have had better. Their goverment let them down. They paid their taxes for nothing, not to mention the pain Bruce endured in his final days. I heard Bruce handled it like the champion he is. He only wanted to see those around him smile and live the good life.

May God richly reward you, Bruce. You should hear those words of old, “Well done my good and faithful servant.” May God comfort your family. May you rest in peace.

Popularity: 41%

Hold the deck.

It’s certainly okay to have the opinion that the FDA made a reasonable choice at the time it denied approval to Provenge in 2007. It’s not the right opinion, but it is a defendable one. It is not all right, based on what we now know, to say they made the right decision.

On the other hand:

That the Provenge BLA was not afforded proper due process is an absolute. Because it clearly was not afforded proper due process nobody can say with any certainty that the FDA made a reasonable decision. Once the process is corrupted it’s all guesswork from there. Nobody knows for sure the extent of influences and back room shenanigans that occurred to assure that Provenge was not fairly evaluated. When CareToLive through litigation and FOIA’s tried to get information they were stymied by the FDA who went to great lengths to avoid any transparency on the issue.

There are aces scattered all over the floor at the FDA and a couple sticking out of a few sleeves so how can the game have been fairly played? Is it too much to ask for a fair game? The denial of a fair PROCESS is the one truth that the FDA could have, should have, admitted.

If that process occurred in a court room there would, at a minimum, have been declared a mistrial, when the evidence of such became known (which was made known to the FDA by petition, litigation and of course lots of letters).

That they did not make a reasonable and common sense decision based on the class of patients for which Provenge was seeking approval, or conduct a proper risk/benefit analysis with a focus on the fact that the treatment was destined for late stage patients is clear.

The FDA said two things that support this; One was that the minority voices on the AC panel were taken into consideration as a factor in the decision making process, and Two is that Richard Pazdur of CDER influenced that process. Top that off with an FDA commissioner who just happens to be a very good friend of Milken……

I don’t want the point to be lost that it is the position of CareToLive that there is no way anyone can say a reasonable decision was made, because the process was completely corrupted. CareToLive has sought accountability and transparency to determine in what ways the process fell short. If the FDA would show us the process then we might be persuaded otherwise. Until then and even because of the cover up itself, it has to be evaluated based on what we know.

The cover up and the lack of transparency is indicative that the FDA made a choice that transparency would make matters worse in this case. Otherwise, why fight so hard to keep the process from the public eye.

What other influences entered into the picture. Political pressure? Milken pressure? Financial pressure? Inside power struggles? Some or all of the above?

The deck was stacked. The dice were loaded. Everybody knows!

With all that you now know about Milken and the depths of his depravity, does it not trouble you that he had considerable control and influence over at least Scher, Martin and von Eschenbach if not others? Continue Reading American Hold ‘Em »

Popularity: 40%

Tonight Ted Girgus to discuss Prostate Cancer and Provenge on Andrew Schorr’s Patient Power 9 PM EDT, 6 PM PDT

http://www.patientpower.info/webcastdetails.asp?dateid=
12/10/2008&webcastid=SCCA121008

If you have any questions you would like answered please
Email questions to: questions@patientpower.info

and help spread the word

Video of Ted Girgus who has late stage prostate cancer and is desperately waiting for the past several years for Provenge approval.

http://youtube.com/watch?v=6Q0uQAL_YDA

12/10/2008

6:00 - 7:00 pm PST

9PM EDT
Navigating Dilemmas Posed by Prostate Cancer Treatment Options
Live from (6:00 - 7:00 pm PST) Pacific. Check back for a link to the live program.

Treatment for localized prostate cancer carries with it not only issues of cancer control, but significant impact on health related quality of life. Measurement of cancer control and HRQOL outcomes is yet to be fully explored by the medical community. In this webcast, join Dr. Bruce Dalkin as we focus on how to measure cancer control in an optimal fashion and .

Guests:
Bruce Dalkin, M.D., Urologic Oncologist, Seattle Cancer Care Alliance
Ted Girgus, Prostate Cancer Patient
Peter Frishauf, Founder of Medscape

How to participate

Email questions to: questions@patientpower.info

Popularity: 52%

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%

The Sixth Circuit Court in Cincinnati, Ohio has granted the request of CareToLive to present oral argument in Appeal No. 07-4465 which is the appeal of the Southern District of Ohio Court decision (case # 07-729).

Oral arguments will be heard on July 29th at 1:30 pm at the Potter Stewart United States Court House, 100 East Fifth St., Cincinnati, Ohio.

Argument will be before a three judge panel. The identity of the three judge panel will not be identified until two weeks before the oral argument date.

Also, Thanks to all the participants that helped make the first ever Coast to Coast prostate cancer demonstrations a huge success!

Continue Reading CareToLive v. FDA — Sixth Circuit Court Grants Oral Argument in Appeal! »

Popularity: 56%

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%

While Michael Milken and the Prostate Cancer Foundation are whooping it up at the ballgame, some men are sneaking off to have their testicles removed in hopes that it will stop their PSA from rising, and their lives from ending prematurely from late stage prostate cancer. 1 in 6 men will be diagnosed with prostate cancer in their lifetimes. Over 30,000 American men will die from prostate cancer this year. Only 1 very toxic drug has been approved for late stage pc in over 42 years.

Along came Dendreon’s Provenge, an Immunotherapy voted overwhelmingly safe and effective by the FDA’s panel of experts convened to review Provenge. Was there foul play afoot when the FDA decided to delay approval. Perhaps if our men put some extra pine tar on their bats, we could get some coverage of this story. You would think that the deaths of 15,000 men since the delay would be enough.

Note the Picture on the bottom — David Solit, Tommy Lasorda, Dr. Howard Soule, Dr. Howard Scher and Mike Milken join together in support of the PCF’s Home Run Challenge at the New York Mets vs. Anaheim Angels game on June 10th, 2005 (click link)

Why hasn’t Michael Milken and his Prostate Cancer Foundation stepped up to the plate and publicly voiced his disappointment and disapproval of the decision by the FDA to delay Provenge? Is Milken financially conflicted? The whole thing is permeating a stench in the world of financially conflicted advocacy groups. Continue Reading Michael Milken and the Prostate Cancer Foundation’s Foul Balls »

Popularity: 97%