FAMEDs Newsletter #6

FREEDOM OF ACCESS TO MEDICINES NEWSLETTER #6

June 15, 2011

PLEASE SUPPORT OUR PROTEST WITH A SMALL TAX-DEDUCTABLE DONATION

We have not asked for a dime in any of our previous newsletters but the time has come to ask you kindly to consider a small donation. Until now, FAMEDS has been funded solely by a small number of Avastin patients, their families and friends. We have not taken a dime from any drug companies.

For the protest, we have had to buy some bullhorns, will rent a bus to shuttle folks to the Hill after the protest, need to pay for T-shirts, making up picket signs, water, flyers and various props. We also need to pay for videoing and filming the event.

All of this costs many thousands of dollars. Please consider donating to FAMEDS to help defray these costs. Whatever you can send will be greatly appreciated.

FAMEDS is the only organization fighting day and night on behalf of the Avastin women. You will be hard-pressed to find any other organization that has created more positive momentum for these women than FAMEDS. By and large the major breast cancer groups and indeed the rest of the cancer community have been far too silent and passive in advocating for these brave women. Yet these larger advocacy groups continue to collect huge mountains of money without representing the Avastin women. We at FAMEDS do not take a cent in salary for our efforts so every dollar you provide is used to support these women.

To donate please click on the following link: fameds.org/makeadonation

We thank you for your continued support!

THE FDA'S CONTINUED CRUEL AND UNUSUAL PUNISHMENT FOR PATIENTS

Time is getting close to the FDA hearing in Silver Spring, Maryland on June 28 and 29th. Final details are being ironed out with the FDA's security folks for the mechanics of the protest, which will take place pretty close to their front door. Certainly, it will be tough for anyone from the media who is attending the hearing to miss us as they enter the building.

We have heard that the FDA will not make its decision about Avastin until mid-August or even into September, 2011. The interminable waiting and uncertainty that the patients have endured will continue yet for months.

Just for a moment, place yourself in the position of these patients. They are fighting a disease for which there is no known cure. They use Avastin and obtain positive results. They and their oncologists agree that they should remain on Avastin.

By the time a final decision is rendered on Avastin it will be 13 or 14 months after the first ODAC committee suggested to the FDA that the indication for metastatic breast cancer be withdrawn from the Avastin label. This continued uncertainty regarding a drug that these patients deem to be their reason for remaining alive is truly cruel and unusual punishment.

STILL LOOKING FOR MORE PEOPLE TO JOIN US AT THE PEACEFUL PROTEST

We are still looking for another 50 or so people to join our peaceful protest outside the FDA on June 28th in Silver Spring, Maryland. The protest will run from 7 a.m. until 8 a.m. so that folks can attend the hearing when it starts around 8 a.m.

If you intend to join us, please sign up at fameds.org/protest. We need to know who will be there so that we can provide sufficient protest T-shirts (pink , of course), create sufficient banners, etc. We do encourage all cancer patients, family members, and friends who plan to attend the protest and / or the hearing to wear pink on the day of the hearing. We want the panel that will make the life and death decision on our Avastin women to know that they are real and our support for them is in that room.

You can also call Ted at (248) 925-7592 for details of the protest and any questions you might have.

We shall hold an organizing meeting for the protest at 8 pm EST on Thursday, June 9 and it will run a maximum of 30 minutes. For those that wish to participate, here are the call-in details:

Conference Dial-in Number: (605) 475-4000
Participant Access Code: 586521#

IF YOU ARE AN AVASTIN PATIENT OR A CLOSE RELATIVE, PLEASE CONTACT US

It is crucial that the Avastin story be told and the best people to tell the world about the importance of Avastin are the patients themselves and their close / immediate families. If you can make a home video (nothing to professional) that we can post or a photo with a letter, we would love to hear from you. Please contact us at terry.kalley@fameds.org or call us at 248.761.8215. We are on EST.

PLEASE SIGN THE FAMEDS PETITION

If you have not had the opportunity to do so prior to now, please sign the FAMEDS petition at fameds.org/petition Thank you for your support – it is vital to the Avastin women that they know that you stand with them in this battle.

HAVE YOU FRIENDED US ON FACEBOOK OR JOINED US ON LINKEDIN, ETC?

Thank you for signing our Avastin petition. Please help us further by participating in our various social media activities at the links below.

Also, please try to get just one friend or associate to sign the petition! This will help us greatly in our efforts.

Fameds.org
Facebook.com/fameds
Twitter.com/fameds
YouTube.com/user/FreedomOfAccessToMed
LinkedIn.com/pub/terrence-kalley

FREEDOM OF ACCESS TO MEDICINES - AVASTIN BLOG

Freedom of Access to Medicines has established a dedicated place to discuss all issues related to Avastin at myfameds.blogspot.com

Please start presenting your opinions.

HOW TO ATTEND THE FDA HEARING ON AVASTIN OR TO VIEW THE HEARING ON THE WEB

fda.gov/NewsEvents

Hearing Information
The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc., on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw accelerated approval of the breast cancer indication for bevacizumab (Avastin). Genentech and CDER are the parties to the hearing.

Date: June 28-29, 2011
Time: 8:00 a.m. – 5:00 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave. Bldg. 31, Great Room, Silver Spring, MD 20993

Docket FDA-2010-N-0621 is available on Regulations.gov. All documents filed or posted in this matter are available for public review under Docket No. FDA-2010-N-0621 in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Federal Register Notice

Attendance and Webcast
If you wish to attend the hearing or view the hearing via webcast, you must register with FDA in advance of the hearing. If you wish to register for either attendance in person or the webcast, you should return to this page: fda.gov/NewsEvents at 10:00 a.m. EDT on May 27, 2011. At that time, links for online registration will be available. You will receive a confirmation e-mail if your registration is successful.

The public meeting is free. Seating is limited to 300 persons from the general public. Availability via webcast will be limited to a certain number of persons. FDA asks that you do not register for both attending the hearing in person and viewing the webcast.

Comments
You may submit electronic or written comments to Regulations.gov. Comments must be submitted by July 14, 2011. You may also submit written comments to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
 
 
Avastin Fight Song


Composer and performer, Andrew Katz, NYC

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