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

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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/

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Good News! Provenge is becoming increasingly available. Dendreon is ramping up the supply following the recent approval of the remaining 75% of their New Jersey plant.

To find out more about Provenge, a first in class immunotherapy treatment for prostate cancer, click this link Provenge.com.

To find out where provenge is available near you, go to the bottom left of that page to this link Find a PROVENGE Provider. Then, insert your zip code to find the locations in your area.

Recently conducted channel checking indicates that demand remains strong.

That data suggests:

The number of patients prescribed Provenge within their sample is up 22.7% sequentially, while the number of new patients who actually received the treatment is up 66.7%.

This is good news indeed!

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Care To Live has been notified by the Department of Justice (DOJ) that the final FOIA response from CMS is expected to be completed and released to CTL not later than April 15, 2011.

As soon as it is released, it will be posted here in its entirety.

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Great news from Dendreon today!

The FDA finally approved the remaining 75% of treatment stations at their New Jersey plant that manufactures Provenge.

This will quadruple their manufacturing capability and greatly help to alleviate some of the current supply/demand problem.

Two more plants in Los Angeles and Atlanta are also expected to be able to begin production in the near future.

Care To Live along with thousands of Patients, Urologists and Oncologists are thrilled that doctors will now be able to treat thousands more men with Provenge, however we will not sleep well until all the men who need Provenge can get it.

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Dr. Scott Gottlieb and Henry Miller (see blog below) recently criticized the FDA for its go slow, risk adverse nature, which is stifling innovation and costing patients quality of life time with family.

Here is the link to Steve Forbes recent article called: How the FDA May Kill Millions of Us.

http://www.forbes.com/forbes/2011/0214/opinions-steve-forbes-fact-comment-fda-may-kill-millions.html

Mr. Forbes states, “A more fruitful approach would be to overhaul the FDA and remove its capricious hurdles.”

The FDA needs patient advocates on staff with real authority to help patients, who can work with patient advocacy groups to enable patients to gain access to innovative treatments sooner. The FDA needs to balance the wealth of statistically rigid bureaucrats who are unable to understand how to weigh benefit - risk in a meaningful manner.

The FDA needs to accelerate approvals and streamline the process. An ongoing example of FDA incompetence is the still non-approval of Dendreon’s NJ Provenge plant, whose request they have had for 3 months now…….while men still cannot obtain the treatment due to supply shortages.

Prostate cancer patients are tired of dying while waiting for the FDA to do its job.

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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 »

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Care To Live To FDA, “Just Produce the Documents”.

Public servants. Hah! More like royalty in gilded cages. Conspiring in their posh abodes to put the kebosh on a cancer treatment without adequate reasons or transparency into their warped decision making process. They can’t use no favorable Advisory Committee hearings. Not when there was so much money on the table.

We seek confirmation of the corruption and retribution commensurate with the crime.

Who was lobbying the FDA and why?

The Care To Live Birthers are here.

Just produce the documents.

We fully intend to continue to force the issue including the removal of the inner sanctum of corrupt officials at the FDA, the CMS, the NCI and the HHS, who have been sabotaging our medical research, destroying valid, impressive, breakthough treatments and delaying approvals for years while they enrich themselves.

How blatant they are in their inconsistency. For such a statistically anal organization, the FDA can’t add one and one and get two. What a sneaky bunch of manipulating, self enriching bureaucrats, who through ignorance or greed, sabotaged a nation.

We demand consistent parameters for one treatment over another.

Yeah, Provenge is approved now. So what difference does it make?

It is at the very core of our democracy that these “regulatory” agencies, who get such a huge chunk of our tax dollars, actually do the jobs they are overpaid to do.

Transparency and Accountability.

FOIA OR BUST!

Join us!

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I prepared for orals expecting a lot of questions. There were not many questions asked by Judge Norris or Judge Martin but quite a few by Judge Cook. Judge Norris and Martin are a couple of salty old dogs and seem a bit more lighthearted then many of their stiffer brethren.

I had 15 minutes, 5 of which I saved for rebuttal. I presented the issue and spoke about how this case was different then most FOIA cases in that we know that there were, and maybe still are, requested documents on the computer of a single individual at the FDA.

We know this by virtue of Richard Pazdur’s admittance that he had the documents on his computer but he deleted them. So in this case the CDER division of the FDA knows where to look. Continue Reading Care To Live Attorney Kerry M. Donahue Argues for Pazdur’s Deleted Documents »

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CareToLive has been notified of its Courtroom and Judge assignment in case 09-4084 CareToLive v. FDA.

Wednesday, December 08, 2010, room 636 - 6th Floor East Courtroom, 9:00 A.M.

Before: Judge Boyce F. Martin Jr., Senior Judge Alan E. Norris and Judge Deborah L. Cook

Oral argument will be heard by this three judge panel on Wednesday, December 8, 2010 at 9:00 a.m. at the Potter Stewart U.S. Courthouse, 100 East Fifth St in Cincinnati, Ohio.

CTL’s filing in the Court of Appeals was in response to the FDA’s refusal to search Richard Pazdur’s computer or the FDA servers for documents that satisfy our FOIA request.

Dr. Pazdur had made a Declaration stating he destroyed all said documents. Kerry states, “Merely asking the fox to count the chickens, without even allowing Plaintiff-Appellant to subject the answers of the fox to any sort of test of accuracy or truthfulness, was improper.”

You can read Kerry’s fine legal filing here: ctlfoiaappellantreplyeditedii030310pdf.pdf

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