FAMEDs Newsletter #2
FREEDOM OF ACCESS TO MEDICINES NEWSLETTER #2
 
Date: May 11, 2011
 
FDA BACKS DOWN AND ALLOWS PUBLIC COMMENTS AT HEARING
 
Freedom of Access to Medicines was one of the first to hear about the FDA allowing patients to speak at the FDA hearing on June 28th at FDA headquarters in Silver Spring, Maryland.
 
Clearly the FDA is feeling the heat that FAMEDS and others are applying. That is a good thing.
 
However, FAMEDS fears that the FDA will hand pick its speakers, and allow its few supporters of its Avastin decision equal time with its many detractors. Even if the 17,500 Avastin patients were to get the full 2 hours allotted to all speakers just to themselves, this is still a paltry 0.41 seconds each. The Avastin women need to be very fast talkers!
 
Here is the letter sent by the FDA:
 
On February 25, 2011, I responded to a request that you had made to make a public presentation at the administrative hearing on the withdrawal of the accelerated approval of the breast cancer indication for Avastin.  In that message, I stated the position we were taking, at that time, that statements by persons other than the two parties to the hearing should be submitted in writing, rather than presented orally. 
 
I am writing now to let you know that we have reconsidered our position on this issue and will have a two hour period, at the beginning of the hearing, for members of the public to state their views.  This change in position is reflected in the notice of hearing which posted this afternoon. 
 
This is the information in the notice concerning registering to make an oral presentation:
 
"If you wish to make an oral presentation during the hearing, you must register by submitting an electronic or written request by May 27, 2011, to Talisha Williams [Office of the Ombudsman, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD  20993, 301-796-8530, email:  Talisha.Williams@fda.hhs.gov].  Depending on the number of requests, FDA may not be able to honor all such requests.  You must provide your name, title, business affiliation (if applicable), address, telephone and FAX numbers, email address, and (if applicable) type of organization you represent (e.g., industry, consumer organization).  You also should submit a brief summary of the presentation, including the discussion topic(s) that will be addressed and the approximate time requested for your presentation.  We encourage individuals and organizations with common interests to consolidate or coordinate their presentations to allow adequate time for each request for presentation. If there are many requests to present during the 2-hour period, the amount of time that can be allotted to each presenter may be limited to provide an opportunity to as many persons wishing to present as possible.  Persons registered to make an oral presentation should check in with Talisha Williams before the hearing.  Participants should submit a copy of each presentation to Talisha Williams."
 
This does not, of course, change the nature or the purpose of the hearing.  However, because there has been a change in our position with respect to public presentations, I wanted to be sure to alert you to this change.
 
 
FAMEDS TALKS ON TWO RADIO SHOWS:
 
Each of these two interviews lasted about 15 to 20 minutes and we thank the hosts for having us on. If you know any radio or TV Stations that wish to give us time, please let us know. Its really important that we get our story out to the American people.
 
Pharmaguy
 
 
The Neal Asbury Show
 
 
 
FAMEDS RELEASES NEW CARTOON MOVIE ON AVASTIN
 
Episode 2 of the Perils of Lee Kay, Avastin Patient can be found at: http://www.youtube.com/user/FreedomOfAccessToMed
 
 
 
HAVE YOU FRIENDED US ON FACEBOOK OR JOINED US ON LINKED IN, 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 AVASTIN PROTEST CALL SET FOR THURSDAY
 
We shall hold a protest outside the FDA headquarters in Silver Spring, Maryland on June 28th, probably from 7 a.m. to 8 a.m. For those interested in attending, the sign-up sheet is live on our website at www.fameds.org.
 
We shall hold an organizing meeting for the protest at 8 pm EST on Thursday, May 12th 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#
 
 
FREEDOM OF ACCESS TO MEDICINES DEDICATES NEW BLOG TO AVASTIN DISCUSSIONS
 
Today, leaders in the battle with the U.S. Food and Drug Administration to retain metastatic breast cancer (mbc) as an indication for the drug Avastin announced a new blog to discuss various aspects of the FDA’s controversial decision.
 
“There is a need for all stakeholders to express themselves on this urgent Avastin crisis” said Terrence Kalley, founder of Freedom of Access to Medicines, (www.fameds.org), a nonprofit organization solely dedicated to protecting the 17,500 Avastin patients’ rights to access Avastin and for their continued coverage by Medicare and private insurance.
Freedom of Access to Medicines has established a dedicated place to discuss all issues related to Avastin at http://myfameds.blogspot.com/
One group discussion invites oncologists, doctors, physician’s assistants, nurses and other health care professionals to discuss medical issues related to Avastin. Do they think that Avastin should stay as an option or not? If a patient is doing well on Avastin, does it conflict with their Hippocratic Oath to remove a patient from Avastin?
A second discussion will appeal to cancer patients using Avastin for metastatic breast cancer, their family and friends. It will explore their thoughts and feelings as the very real threat of removal of their life-saving medication draws ever nearer.
The third discussion will be political in nature and aimed at concerned citizens from the left and right, lawyers, activists, tea partiers, libertarians and others. Is this government interference in what should be the most individual of choices or is this the government looking out for the best interests of the public? Is this another action against a woman’s right to choose or is this the ultimate threat against right to life?
The final discussion group should appeal to FDA employees, pharma and bio employees, medical advocacy groups, patients with serious illnesses and others with interests in the medical community.  It will explore whether or not the FDA and Genentech have handled the Avastin matter well, how this will affect drug development in the U.S. and if the FDA is being too harsh in its dealings with drug companies or needs to crack down further on dangerous drugs reaching market.
Kalley continued: “The Avastin issue touches on many issues, some personal others with global, industry and societal implications. By dedicating http://myfameds.blogspot.com/ just to Avastin, we expect many high quality discussions.”
 
 
 
Avastin Fight Song


Composer and performer, Andrew Katz, NYC

Latest News
6
June
Cancer drug's approval matter of life, death
Read More
27
May
Local couple fighting FDA over cancer drug Avastin
Read More
Social