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Posts Tagged ‘howard i scher’

HHS Desperately Needs Transparency Lessons From CMS

April 28th, 2011 | Posted by CTL

Human Health and Resources (HHS) transparency rules differs greatly between divisions. Center for Medicaid and Medicare (CMS) has been forthcoming with our Freedom of Information (FOIA) requests, while the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) continue stalling. 

Read more at Pharmalot http://www.pharmalot.com/2011/04/the-fda-conflicts-of-interest-provenge-e-mails/

Popularity: 24%

Care To Live Sets Up A Reward Fund - A Friend Contributes $500

October 29th, 2010 | Posted by CTL

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

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

Here is that e-mail:

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

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

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

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

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

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

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

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

Popularity: 25%

FDA Creates Human Ticking Time Bombs

February 28th, 2009 | Posted by Rory Kearney

 The Wick Family has 4 men with prostate cancer. Too late. Make that 3. Brad’s Uncle died this week. If Provenge were approved 2 years ago, as it should have been, he might still be with us today. With his permission, here is what Brad wrote.

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My uncle

I would like to ask for your thoughts and prayers for my family - my favorite uncle died yesterday due to cancer.  It was a catch 22 for him, his platelet count was too low due to the chemo killing them off, but his only treatment for his Stage 4 cancer was chemo.  He had prostate cancer, but cancer had spread to other areas - his lungs, liver, and back.  He has had chemo treatments over the past several months and would have good and bad times.  But with his platelet count low, they wouldn’t give him chemo and he went downhill much faster than any of us expected.  He tried to get into clinical trials but none were accepting patients or there were none available in the area.

It pains me to no end that potential life saving treatments are on the horizon, but are often shot down due to self preservation, greed, and cost/red tape to get the product to market.  I miss him and my mom is just torn up.  I hope and pray that treatments like Provenge can be out there to help give patients a fighting chance.  I know that it won’t save every patient, but to me 20%+ is better than 0%……and patients can live a life with dignity and pride and not put up with the horrible side effects that I have seen ravish my uncle (lost hair, weakness, poor sleeping, etc).  When will the FDA start wearing the “patient only” glasses without the outside distrations?

Thanks for letting me vent.  This has been a tough time.

May God bless those fighting for what is right and for those stricken with this horrible disease.  You are the true heroes!

Brad Wick

(click on pictures to enlarge)

* * * * *

Words cannot express how sorry those of us at Care To Live feel. We are doubly sad, because Care To Live member Brad Wick, has done so much to help us in our battle to get Provenge approved. He has been there with us every step of the way.

When we did our Rockville, Maryland newspaper campaign, (in the FDA’s backyard),  his Dad and Mom allowed us to use them in an ad. What a great picture of them and Brad’s children, (and niece too). Our thoughts and prayers go out to the Wick family.  It is people like Brad, the best in the world, that make it clear we must double our efforts. We must get Provenge made available NOW!

One in 6 men get prostate cancer. 30,000 of them go on to die from it every year. Dendreon’s Provenge is a non toxic, non invasive immunotherapy, that is administered in a few treatments in the doctors office, using the patients own white blood cells. These fighter cells are retrained to attack and destroy the cancer, like they did when you were healthy.

Eduardo Garcia, was in the Provenge trials over 7 years ago. Until that time, he had crawled back into bed waiting to die, too weak to do anything, a common effect of late stage prostate cancer. After he had his three infusions, he became so strong and healthy that he went back to work.

Provenge went before the FDA for approval over 2 years ago. A panel of experts was convened, who voted it 17-0 safe, and 13-4 substantial evidence of efficacy. Two “doctors”, namely Howard I Scher, and Maha Hussain, from the chemotherapy industry put on the panel by Richard Pazdur aka “the cancer czar”, both had severe conflicts of interest, and had to sign waivers although they conveniently left out many of their conflicts. They were both very vocal at the panel, that they needed more proof. Provenge has already been through over 10 years of Phase I, II and III testing.

The “doctors” lobbied the FDA to delay approval. Letters were leaked to the same inside non peer reviewed source that published the imclone erbitux non approval, sending Sam Waksal, CEO of Imclone, and Martha Stewart to jail. We believe that Richard Pazdur of the FDA was the “leaker”. Richard Pazdur of the Chemotherapy, Radiation side of the FDA, ran roughshod over the approval process, (passing notes to one of the conflicted doctors etc), even though Provenge is a biologic agent and did not reside in his division. Imclone’s Erbitux was subsequently approved for colon cancer, unfortunately not in time to help those who died waiting. A congressional hearing was called over Imclone.

We had several Congressmen call for a hearing over the Provenge debacle,  but John Dingell of Michigan refused to hold it. His wife is tied to the cancer industry. Congressman John Dingell (Michigan) and Frank Pallone (New Jersey) decided against a Congressional hearing for all the wrong reasons. You can read their response to those calling for hearings. 2/13/08
micha001.pdf
Three Congressmen, Mike Michaud (D) of Maine, Dan Burton (R) of Indiana, and Tim Ryan (D) of Ohio called for a congressional hearing into the conflicts of interest and what went wrong at the FDA causing the delay of Provenge. (click this link) Read the Congressional Letter calling for a Hearing 12/13/07.

Besides, Congress is too busy holding hearings on steroid usage in baseball players, which nobody has died from. Who cares about 30,000 sick old American men. In reality, men are dying from prostate cancer in their 30’s and 40’s as well.

The really sick people are those running the FDA. They oversee a corrupt, dysfunctional bureacracy, with little care for the lives and health of the citizens of the United States. They are more concerned with power and lining their own pocketbooks.

Billions of dollars paid out to pharmaceutical companies, hospitals, stock holders, and Wall Street titans, will be lost, if the entrenched Oncology treatments are replaced by immunotherapies. This is an uphill battle, but one we need to fight, for all of our sakes.

Dendreon has immunotherapies for breast cancer, colon cancer, etc, on the back burner, due to the delay in Provenge approval, causing a depletion of their research and trial money. This is the way wall street plays the game and influences the FDA decisions. Delay and destroy. If not for Care To Live Provenge would have been long gone, possibly even being bought out by a larger company, whose goal would be to throw it in the trash heap, to ensure nothing interfere with their profits from the current toxic, debilitating treatments and the billions spent managing their horrible side effects.

The common protocols when you are diagnosed with prostate cancer is usually either removing your prostate gland, or some type of radiotherapy such as implanting radioactive seeds in your scrotum, which kill the cancer cells. Unfortunately they kill they healthy parts of your immune system too, and radiate your vital organs. You may also opt for watchful waiting now called active surveillance. Most men are encouraged to be treated. If your cancer progresses, they will give you hormone therapy, which is really female hormones, to try to supress your testosterone. All men who go on hormone therapy, will eventually fail, unless they go on to die from something else.

Provenge has show survival in 20% of the sickest men, those in late stage, who have already had either their prostate gland removed, or been radiated, and also had hormone therapy which is no longer working. These are men whose cancer has already metastacized to their bones and organs. Imagine what it might do, were it given to men earlier in their diagnosis.  Once an immunotherapy is approved, it will be a paradigm shift in the way cancer is treated.

Michael Milken, runs the world’s largest prostate cancer charity in the world. He has been silent during this entire fiasco. The Provenge interim results of another Phase III trial were recently released, showing 20% survival. Not a word from him or his Prostate Cancer Foundation. It is apalling but not surprising. Milken, is a convicted felon who sent time in jail for stock manipulation, and has investments in Provenge competitors. His “faster cures” nonsense, rings hollow with us. He helped fund the Proquest Investment fund. He is busy shaking his can everywhere, asking for more funding to begin research 10 years away from approval, but has nothing to say about Provenge, which is ready, willing and able to be used RIGHT NOW! It is an abomination.

Proquest Investment News Release Link
Nov-01-1998 Start-Up 1 The Opportunity in Cancer: Goldberg’s Variation Prostate cancer will be the focus of ProQuest Investments LP, a new venture fund founded by Jeremy Goldberg. With investors the Ann and Robert H. Lurie Foundation of Chicago, Alza Corp., and high net worth individuals, including Michael Milken, ProQuest has raised $40.5 million in its first closing.

May-01-2000 Start-Up Proquest Investments LP Proquest Investments is a $100 million oncology-focused investment fund, partnered by Jeremy Goldberg and Jay Moorin. The firm aims to leverage its specialization and focus to create a brand that will make it the preferred VC firm for Internet, device, biotech and pharmaceutical companies with products that advance the treatment and cure of cancer, its founders hope.

Former FDA Commissioner Andy Von Eschenbach, was repeatedly asked to reconsider the Provenge decision. He refused. He did go on to lobby President Bush for Mike Milken’s pardon. Just recently he took a job at Greenleaf Health llc.“ This is from the press release. As I look forward to new opportunities to transform healthcare, I am pleased to contribute to Greenleaf’s efforts on behalf of the public health,” Dr. von Eschenbach said. “Working with Greenleaf’s clients to help them bring life-saving therapies to the patients and doctors who need them is one gratifying way for me to provide input on crucial health policy issues.” Read the press release here >> http://greenleafhealthllc.com/PressRelease_VonEschenbach.html

Over 54,000 American men died of prostate cancer while Von Eschenbach was Commissioner. None of them were allowed to use Provenge to fight for their lives. Where is the outrage?

Here is a picture of Milken, Pazdur, and Von Eschenbach.

 

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* * * * *

Madoff Whistleblower Markopolos at the Congressional Hearing on the 50 billion dollar ponzi scheme.

Congressman Alan Grayson: 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 Alan Grayson: 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

 

* * * * *

Where are most of the other prostate cancer advocacy groups. Provenge has been delayed for almost 2 years, for no damn good reason. Everybody needs to raise their voice. We need Provenge Now.

We thank Frank Burroughs and Steve Walker of the  Abigail Alliance, Scott Riccio of Accelerate Progress, Charles Reinwald of the Cancer Cure Coalition, and Attorney Kerry Donahue, Arnold Mass, Melody Davis, Mike Kearney, and many, many others of our loudest and staunchest advocates.

Please Join Us at CareToLive. http://www.CareToLive.com

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Video of Ted Girgus, making a plea for Provenge

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

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See more picture here http://caretolive.com/rally/

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Here is a Video of the 2007 Rally at FDA headquarter  http://www.youtube.com/watch?v=UqAx7uZAS90
* * * * *

We also tried suing the FDA for access, but the courts would not hear the case, as they said the decision is not final. Tell Brad Wick’s family that the decision was not final. There is so much more to this story. You can read more at CareToLive.

OBAMA CAN YOU HEAR US?

website

http://www.whitehouse.gov/

Congress your Representatives

Contact your Representatives and Senators and ask them to call for an investigation into the FDA’s handling of this travesty.

HOW TO FIND YOUR REPRESENTATIVE

Contact Your Elected Officials

by email http://www.conservativeusa.org/mega-cong.htm

by zipcode http://www.visi.com/juan/congress/index.html

If you go to the Congresspedia site http://www.Congresspedia.com and put your Representative’s name in the search box and scroll down and you will find all current contact information. Contact their Washington office as they have the most clout.

Call your Representative and ask for their Congressional Health Staffer.

Follow up with emails and faxes.

If you can visit their office.

Contacting the White House [En Español]

Mailing Address The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500
Phone Numbers Comments: 202-456-1111
Switchboard: 202-456-1414
FAX: 202-456-2461
TTY/TDDComments: 202-456-6213
Visitors Office: 202-456-2121

E-Mail Please send your comments to comments@whitehouse.gov

Vice President Joe Biden: vice_president@whitehouse.gov

PLEASE JOIN US!!!!   THIS IS AN EMERGENCY!

Permission is granted use all pictures and copy to help spread the word near and far.

http://www.CareToLive.com

* * * * *

(written to the tune of Harry Chapin  - Cat’s in the Cradle   http://www.youtube.com/watch?v=zlHdjjHNEC8 )

Popularity: 22%

What is a Life Worth?

October 9th, 2008 | Posted by Mike Kearney

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

Video of Care To Live member Ted Girgus taken at our nationwide protest in Seattle. Ted has stage IV prostate cancer, that has metastacized to his bones. Ted and his doctor, want him on Provenge NOW!

* * * * *

Here is a Video of the 2007 Rally

http://www.youtube.com/watch?v=UqAx7uZAS90

MAY 30, 2008 NATIONWIDE PROSTATE CANCER PROTEST

* * * * *

20% of 42,000 Lives = 8,400 Lives & Counting

Money is very important to most people yet nobody can measure how many dollars one life is worth. There is no amount of money, no matter how much, that is worth trading for one single life. If one life is so very valuable to one family, then how much are 8,400 lives worth?

Ever since the FDA delayed getting Provenge to men with late stage prostate cancer over 42,000 men have died. If they were on Provenge since May 2007, at least 20% would still be alive. That is over 8,400 men that would have benefited.

In other words the FDA would have approved Provenge if it saved 9,240 people, but because it only saved 8,400 people’s lives, they won’t let us have it. The bureacracy must be using artificial intelligence to come up with their faulty conclusion to delay. The FDA already told us the agency is too broken to keep up with the science.

There are currently 90,000 to 100,000 men with Androgen Independent Prostate Cancer (AIPC), or are hormone refractory. That’s 18,000 to 20,000 people. AT LEAST THEY COULD BE SAVED, according to interim data just released. Keep in mind that the final data will even be more impressive.

CareToLive has again written to Dr. Jesse Goodman, the Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). CareToLive sent Dr. Goodman a Citizens Petition on July 27, 2007, to reconsider the denial of a license for Provenge, an immunotherapy treatment for men with late stage prostate cancer. The petition was sent to the FDA over a year ago and as per Federal Regulation CareToLive should have received an answer within 180 days after receipt. We are still waiting.

Additional data for Provenge has recently been evaluated and has shown what we at CareToLive have been saying all along. Provenge is safe and Provenge shows a survival benefit. An outside firm has just confirmed that 20% of the men in the Provenge trials survived over placebo, due to the Provenge treatment. It is time for the FDA to grant approval, even if only conditional while more data is gathered, so that men with late stage prostate cancer can begin receiving Provenge NOW!

Link to CareToLive’s Citizen’s Petition http://caretolive.com/caretolivepetition.pdf

Here is the letter CareToLive sent to Dr. Jesse Goodman:

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Jesse L. Goodman, M.D., M.P.H.
Director
Food and Drug Administration
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448

Re: Docket No. 2007P-0297/CP1

Dear Dr. Goodman,

I am requesting that the FDA reconsider our CareToLive Citizens Petition docket number 2007P-0297/CP1 filed in July 2007, concerning the FDA delay of Provenge licensure for men with late stage prostate cancer. To date we have never received a proper answer and have only received one letter from you, stating that our petition is still pending. Enclosed is additional data obtained from the Independent Data Monitoring Committee (IDMC) from the Interim look, proving that the survival is real. Provenge clearly demonstrated a 20% reduction in the risk of death in the Provenge arm relative to placebo.

My husband Mike Kearney and I both spoke to Paul Richards of the FDA Consumer Affairs CBER Department, whom your office directed us to. He is supposed to be working for Consumer Affairs but he obviously does not have the consumer in mind. Mr. Richards stated that he himself looked at the data and did not see the survival. This is shocking, seeing that even Dr. Maha Hussain, of “leaked letter” fame said at the meeting that she saw the survival. She wanted to make sure it could be attributed to Provenge. This additional IDMC data proves that the survival is indeed due to Provenge. Mr. Richards refused to answer our question as to whether Provenge is safe. The IDMC clearly states that Provenge is safe, and the FDA Advisory Commmitee voted unanimously that Provenge is safe, so that should not be an issue, despite Mr. Richards refusal to admit Provenge’s safety profile. Mr Richards told us that the minority panelists swayed the FDA decision to delay Provenge. Another of the minority panelists, Dr. Howard Scher, also of “leaked letter” infamy, had many undisclosed conflicts of interest, including running a competitior’s trial for prostate cancer with Novacea’s Asentar, a trial that was stopped midstream due to the high number of deaths, possibly caused by Dr. Scher’s trial design, which caused an abundance of toxicity to the poor patients enrolled.

Our Citizens Petition, which is also attached, addressed the shenanigans that took place during the FDA Provenge BLA process. The FDA correctly granted Provenge Fast Track Status and Priority Review since it is a treatment for a life threatening disease where no viable alternatives exist. Regardless of what took place in the past, in light of the corroborating scientific evidence seen at the Interim, it is time to to reconsider our Petition concerning the denial of a license for Provenge for men with late stage prostate cancer.

To date, over 42,000 men have died without the benefit of Provenge. A 20% improvement in survival means that more than 8000 of them might still be alive if given the right to fight for their lives. It is a travesty that the FDA, which is sworn to protect the public health, has instead ignored these men in their battle with prostate cancer.

The FDA can fix this by allowing the 96,000 men who are eligible for Provenge right now, the chance to fight for their lives. Please restore the American people’s faith in the FDA, and in light of the new data, honor that Fast Track Status and Priority Review. Please reconsider the CareToLive Citizens Petition to reconsider the denial of a license for Provenge. This is an emergency!

Thank you for your immediate consideration of this matter.

Very Respectfully,

Rory & Mike Kearney
CareToLive,
a not for profit corporation

Cc: Division of Dockets Management (HFA-305)
Paul Richards, FDA Consumer Affairs
Lanessa Hill, FDA Consumer Affairs
Stephen Ripley, FDA Consumer Affairs

Popularity: 13%

THE STONEWALLING CONTINUES

August 15th, 2008 | Posted by Mike Kearney

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: 21%

Andy Comes Clean - Turns Over Freedom of Information Documents to CareToLive

March 5th, 2008 | Posted by CTL

13 pages of Freedom of Information (FOIA) documents received from Commissioner von Eschenbachs office concerning the Provenge License Delay for Prostate Cancer Debacle 3/5/2008.
READ THEM HERE
foi-docs-recvd-3-4-08.pdf

If you recall on 1/30/08 we were told there were no documents from Andy.
FOIA denial that Andrew Von Eschenbach received any documents concerning the “leaked” letters despite the fact that Dr. Scher & Dr. Maha Hussain CC’ed Von E their letters prior to “leaking” them. 1/30/08 (click this link)

See the research page of CareToLive for other Freedom of Information documents we received.

Popularity: 10%

Proquest Tries to Cover Its Tracks over Scher Provenge Debacle

January 2nd, 2008 | Posted by CTL

We are hot on the trail of the miscreants that derailed Provenge, a safe and effective immunotherapy for prostate cancer, condemning 30,000 American men to death without hope, in order to reap windfall profits.

Ed Silverman of Pharmalot reports on the shenanigans. (click link)

They may have taken down the links but we have the Proquest Investments 2007 Scientific Advisory Committee on our CareToLive research page showing the connections to Howard Scher and Milken’s Prostate Cancer Foundation that claims they want faster cures, yet remained mum on the Provenge Debacle. 3 Congressment are now calling for a Congressional hearing.

See our prior blog on Michael Milken’s Prostate Cancer Foundation and The Proquest Investment Fund / Howard Scher /FDA Unholy Alliance.(click link)

CareToLive is asking the public to help get to the bottom of the Provenge debacle by joining Congressmen Mike Michaud of Maine, Dan Burton of Indiana, and Tim Ryan of Ohio, who are calling for a congressional hearing into what happened. Contact your elected officials to ask for a congressional hearing, visiting the CareToLive website, dig our blogs, and join in the battle.

30,000 American men will die each year (not to mention the rest of the world) without this safe and effective immunotherapy. 1 in 6 men will get prostate cancer int heir lifetime. The FDA’s delay of Provenge was unprecedented in a terminal disease with an overwhelmingly positive panel that showed survival advantages, where no other options exist. Only one treatment for prostate cancer has been approved in 42 years. Send a clear message to Congress, the dysfunctional FDA, Wall Street, and the Chemo Cartel that we want this nontoxic immunotherapy approved NOW! More than 10 years of trials have shown it increases survival. Some men are alive as long as 6 years.

CONGRESSIONAL LETTER ASKING FOR A HEARING  PDF (click here) Please fax this letter to your own congressional representatives and ask them to join this action. TIA
Continue Reading Proquest Tries to Cover Its Tracks over Scher Provenge Debacle »

Popularity: 12%

Michael Milken and the Prostate Cancer Foundation’s Foul Balls

November 18th, 2007 | Posted by CTL

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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: 28%

Sleepless in Asentar

November 15th, 2007 | Posted by CTL

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: 29%

Supplemental Memorandum Plaintiff CareToLive

November 9th, 2007 | Posted by CTL

Download the Memorandum - Click here

CareToLive Attorney Kerry Donahue files on behalf of the men with terminal prostate cancer who are running out of hope and time as thet desperately seek Provenge. We need everybody’s help in calling attention to this grave situation. Please Leave your comments and digg it. TIA

P.S. Two fleets of buses are rolling around DC and Rockville with our “Get on the Bus Gus” Provenge Confidential ad campaign.

Popularity: 22%

Death by Wall Street - Rampage of the Bulls
Provenge is approved!

    Provenge has been approved! Thank you to all who helped achieve this important milestone for cancer patients.
CATEGORIES

WHATS GOING ON

This Is An Emergency!

We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.

The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK

These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.

The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.

These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.