Frank Burroughs of the Abigail Alliance informs us there is a protest planned at the FDA June 28.

Care To Live urges all people who have a beef with the FDA to make a sign and join them.

Freedom of Access to Medicines, along with the Abigail Alliance for
Better Access to Developmental Drugs, and others plan to hold a peaceful
protest outside the FDA hearings on Avastin on June 28th, 2011.

The protest is in support of the fight of women to choose the
life-saving drug Avastin, and the issue of better access to promising
developmental therapies for cancer and other serious life threatening illnesses.
An estimated 17,500 women with incurable metastatic breast cancer
currently rely on Avastin to stay alive. With your help, they and their
doctors will remain free to choose Avastin.

Due to the actions of the U.S. Food and Drug Administration, these
women’s lives are threatened. Defend these women’s right to choose the
medicines that keep them alive today and you will be protecting your life
tomorrow.

The location of the June 28-29 hearing will be the Great Room on the
FDA White Oak Campus located at 10903 New Hampshire Avenue, Silver
Spring, MD 20993.

For more information about the White Oak Campus, please click on this www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm[1]
More details regarding the protest will soon be available at:
http://www.fameds.org/protest.php

Abigail Alliance for Better Access to Developmental Drugs
www.abigail-alliance.org[2]
8881 White Orchid Place
Lorton, VA 22079
703-646-5306

COMPASSIONATE ACCESS ACT: The Abigail Alliance along with others is
in the process of very significantly reinvigorating the Compassionate
Access Act in the U.S. Congress.

DOCUMENTARY: Sometime mid to late this year a documentary featuring
the Abigail Alliance will be coming out!

ALSO, the Abigail Alliance has a VERY tight budget, so your help
KEEPS US GOING.

Donate to Abigail Alliance

Links:
——
[1]
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
[2] http://www.abigail-alliance.org

Popularity: 16%

Dear CMS,

Please consider first and foremost the men and the families who love them. These are the true beneficiaries of the Provenge Medicare coverage. To you they may be portrayed as points on a graph, but to us, each and every one of these men, matter greatly. We call them Dad, Grandpa, Son, Brother and Husband.

During the approval and now coverage process, we have experienced moments of extreme joy and devastating heartbreak. The almost five year old continuing Provenge saga, ongoing since Dendreon first filed the clinical portion of their Biologics License Application with the FDA in 2006, has ended up on your doorstep to make a coverage determination by June 30. So many of our men’s hopes and health are now riding on you.

We at Care To Live would like to make clear to CMS, FDA, NCI and all the other government agencies peripherally involved, that this process that Provenge and other treatments go through is much too long and much too arduous for the patients awaiting treatment. Serious consideration must be given to find ways to get these exciting new treatments to the patients who are without viable alternatives to death, sooner, including passage of the Abigail Alliance sponsored Access Act.

The FDA in particular, needs to help bring treatments for late stage disease, like late stage prostate cancer, to the patients earlier. During the Provenge approval process, the FDA and the NCI sadly acted as patient adversaries and barriers, instead of the bridge that we were promised.

Within CMS’ own walls, mistakes were made. We hope you will strive to avoid these careless actions in the future. Never should safety and efficacy, already put through a long and laborious FDA review process, ever be evaluated by your agency. If you decide to evaluate a treatment based upon your stated intentions, such as uniformity of coverage and classification of reimbursement, then you must make it very clear at the outset that this is your intention.

CMS lacks authority to re-evaluate data provided by the FDA for a treatment’s safety and efficacy. Such action is particularly ill conceived when it is a treatment for late stage cancer. Without fast action by Dendreon, patient advocates, and several Congressmen, many more men may have been denied treatment. Total catastrophe was averted but not before your agency came close to creating chaos as seen through the eyes of many patients, some of whom urged Congress to get involved.

This should never be allowed to happen again.

Despite what some have said in these comments and elsewhere, making late stage prostate cancer patients out to be sick old men, that is just plain wrong. Most are still active, vital people, with no outward signs of disease. Some are still quite young, and all, if left untreated, will die too early of a very painful disease.

We are not about to let that happen. Care To Live Continue Reading Care To Live Submits Moment of Silence to CMS »

Popularity: 29%

by Kerry M. Donahue

FDA commissioner Margaret Hamburg recently defended the FDA against criticisms leveled by former FDA Deputy Commissioner Dr. Scott Gottlieb and Hoover Institute fellow Henry Miller. She took issue with the idea that the FDA is not following the mandates of Congress to get safe and effective new treatments to patients in a timely way, particularly late stage patients with few, if any, viable alternatives.

Of course those who followed the Provenge approval process with CareToLive understand that FDA figurehead Hamburg is baffled, befuddled and completely out of touch with the reality of the situation. Ms. Hamburg needs to look no further than the case of Provenge and the now 15 other effective treatments for late stage diseases that heroes like Frank Burroughs at the Abigail Alliance http://abigail-alliance.org/ supported, and which were all eventually approved for treatment of life threatening diseases. Unfortunately not before hundreds of thousands of patients died, sometimes from terrible and painful diseases, without ever having been able to obtain these treatments.

The fault lies squarely with the FDA process and their failure to prioritize and accelerate review as demanded by Congress, and by humanity itself. Continue Reading FDA Trifecta — Gottlieb Calls Em Out, Miller Rallies on the Rail, Hamburg Limps Lamely to Finish »

Popularity: 15%

 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.

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.

* * * * *

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

* * * * *

Video of Ted Girgus, making a plea for Provenge

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

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

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]

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%