Urgent Action You Can Take

URGENT ACTION REQUIRED TO SAVE THE AVASTIN WOMEN

SENATOR CIRCULATING A LETTER FOR SIGNATURE BY OTHER SENATORS TO SAVE THE AVASTIN WOMEN. WE NEED YOU TO URGE YOUR SENATOR TO SIGN THIS LETTER.

Please urgently contact your two Senators and urge them to sign a letter circulating in the Senate to protect the Avastin women. Please click here to read the letter. This is one of our last hopes to influence FDA Commissioner Hamburg, who will make the final decision on Avastin probably within the next month.

Attached you will find the letter Senator Wicker is circulating around the Senate. Please contact your Senators, and ask them to contact Wesley Clay on Senator Wicker's staff to sign the letter. He can be reached at wesley_clay@wicker.senate.gov or (202) 224-6253.

Please click on the link below, find your State on the map, click on it and then you will see the contact information for your two Senators.

www.congressmerge.com/onlinedb

You can call or you can e-mail. E-mail may be best. Here is the outline of the text that you can use in an e-mail to your Senators: A recent Food and Drug Administration (FDA) panel recommended the withdrawal of the cancer drug Avastin. Initially approved by the FDA, Avastin has been vital to many in the treatment of metastatic cancer and has produced significant benefits for some patients on the medication. Please call on Commissioner Hamburg to consider the lives of your constituents who value extended life during their quest to fight breast cancer and allow Avastin to remain an option for treatment.

While drug safety is an important consideration, patients taking Avastin are running out of time and options for treatment. Decisions on patient treatment for this serious disease should be made between patients and their doctors. Until a cure is developed or other successful treatment alternatives are available, patients with metastatic breast cancer should be given the option of taking Avastin.

FDA Commissioner Margaret Hamburg is expected to make the final in the coming weeks. A letter from your office will ensure your constituents' concerns are heard.

URGENT ACTION APPEAL TO SAVE THE AVASTIN WOMEN – TIME SENSITIVE!

We need your immediate help today and the rest of this week to contact key individuals at the Centers for Medicare and Medicaid Services (CMS) and also Congresspersons on the Health Subcommittee of Energy and Commerce that oversees the FDA. The Energy and Commerce Committee's Health Subcommittee will hold a hearing this Thursday regarding the FDA and the upcoming renewal of Prescription Drug User Fee Act. The Committee is also expected to address the Avastin issue. Talking points and contact details follow below.

Last Thursday, 6/30/11, Reuters reported that CMS would continue to provide insurance coverage for Avastin for those covered by Medicare. An hour or two later, this was followed by another statement indicating that CMS might reevaluate its position on Avastin within a year.

Rumor has it that CMS may issue clarification on this extremely soon, possibly as soon as Wednesday, July 6th. The outcome is a life and death decision for our Avastin women. Right now, the betting is thatonly those already on Medicare at the time of the decision will continue to be covered. Women who become eligible for Medicare after that date, including even those already taking and benefiting from Avastin, will not be covered. We need to demand that all women currently on Avastin be covered once they become eligible for Medicare. The most appropriate outcome would be for CMS to continue coverage of Avastin for metastatic breast cancer (MBC) for all women who now, or in the future, will become eligible for Medicare, pending completion of the planned additional studies propsed by the drug's sponsor. It is likely that any move to restrict coverage of Avastin will also cause private insurers for women not yet eligible for Medicare to reconsider their coverage, as well.

Failing to continue coverage for Avastin would be totally unacceptable. Think of a patient aged 64 on Avastin with private insurance coverage. When she turns 65 and becomes eligible for Medicare coverage, why should she remain without coverage while someone a year older is covered?

Also, this needs to be a final ruling. We can't continue to torture these women and their families with uncertainty. We can't have Medicare covering women today and remove it in a year again. That is a totally unacceptable outcome. The uncertainty regarding the availability and coverage of Avastin is already making the critical process of mapping treatment plans for existing patients difficult, if not impossible, and always results in less than optimal care.

Lest you think that we are forgetting about the Avastin women on private insurance, we are not. It is vital to get the CMS locked into the Medicare coverage first as this will serve as an anchor for the private insurers. Clearly the private insurance companies are not bound to follow CMS, but they often do, and the more coverage we have locked up at CMS, the harder it will be for these private insurers to justify abandoning existing coverage for the Avastin women.

It is important to consider this situation in context. The European Medicines Agency (FDA's counterpart in the European Union) has unequivocally endorsed the continued use of Avastin for MBC. Similarly, the National Comprehensive Cancer Network (a consortium of leading oncologists in the US that issue oncology practice guidelines) has unequivocally stated that Avastin should remain available for this indication. CMS should not compound the serious mistake being made by the FDA by limiting coverage for Avastin. Instead, CMS should reject the FDA's mistake by continuing coverage.

ACTIONS REQUIRED WITH CMS ON TUESDAY 7/5/11 & 7/6/11 (OR LATER IF ONLY POSSIBLE THEN)

  1. Call and e-mail the following persons:
    1. Donald Berwick, Administrator of CMS = head
      1. Donald.Berwick@CMS.hhs.gov
      2. Tel: (202) 690-6726
    2. Donald McLeod, Spokesman for the Centers for Medicare and Medicaid Services = person who put out statements last week that seem confusing
      1. Donald.McLeod@cms.hhs.gov
      2. Tel: 202-690-6145
  2. Demand that:
    1. Medicare coverage remain in place for existing and future Medicare patients on Avastin, or for whom their physicians recommend should begin Avastin after becoming eligible for Medicare.
    2. Medicare needs to cover existing Avastin patients when they become eligible for Medicare coverage. Not to do so would mean that current Avastin patients on private insurance would cease to be covered when they become eligible for Medicare, an absurd situation.
    3. Medicare needs to issue a final statement on the above two issues. This should not be subject to review within a year or else the coverage in a) and b) above could be removed. We need closure to this matter.
  3. If you cannot reach these individuals, then ask to leave a voice mail or other form of message. If these are the wrong individuals, please find out who else you can talk with or leave a message for. Good luck!
HEARING ON FDA SET FOR JULY 8, 2011 – WE NEED YOU TO ACT

Last week the handpicked and biased panel of the FDA voted 6-0 four times against Avastin. As FAMEDS had warned before the hearing, the outcome was never in doubt. The panelists were supposed to be independent of the part of the FDA they were advising – the Office of Oncology Drug Products, headed by self-appointed cancer czar, Richard Pazdur. As was disclosed by others in great detail at the hearing last week, he handpicked each of the panelists – hardly independent advice. Furthermore, 5 of the 6 panelists (who were picked from the standing roster of the Oncologic Drugs Advisory Committee, or ODAC) had already voted against Avastin last year, establishing that the intent of FDA was to stage a show hearing configured to produce a negative vote while trying to create an "appearance" of process and impartiality. The sixth panel member was handpicked by Pazdur right before the hearing (in May – after the hearing had been scheduled and Pazdur was supposed to have been completely separated from its administration). Consequently, the new physician, Dr. Frank Balis, added one more safe vote for the FDA. The other sitting members of ODAC (an additional 7 are currently on the committee) did not participate, including an appointed representative of consumer interests who voted for retention of the indication last July. The FDA has provided no information regarding their absence from the hearing.

None of the 5 physicians selected for the panel have experience in treating breast cancer; thus resulting in a highly irregular use of the committee that violates both the intent and the letter of the Federal Advisory Committee Act. The next step at the FDA is that the head of the FDA, Commissioner Margaret Hamburg, will rule on the panel's advice sometime in the future, speculated to be mid-August to September. Commissioner Hamburg is a political appointee and as such her decision by definition will take political considerations into account. FAMEDS has taken a scrupulously non-partisan political view of the Avastin situation and will continue to act in this manner. Metastatic breast cancer strikes women of all political beliefs, national origins, religions, etc.

We need to enter the political debate in a non-partisan manner this week. The Health Subcommittee of the House Energy and Commerce Committee that oversees the FDA will be meeting on Thursday. They will be questioning some high level FDA personnel at the meeting, which is examining the reauthorization of important legislation aimed at making the FDA a more effective and responsive agency.The Chair of the Energy and Commerce Committee is Fred Upton, from Michigan. Congressman Upton also sits on the Health subcommittee. FAMEDS has previously met with Upton's staff as well as the staff of the Subcommittee on Health Chairman, Congressman Joe Pitts. It is vital that you call, e-mail, fax, etc. as many members of the Health Subcommittee and their health care aides as possible.

To date, the Committee has failed to exert the necessary oversight over FDA's mishandling of Avastin for MBC, but news reports since the FDA hearing indicate that Chairman Upton or another member of the subcommittee will be questioning the FDA on the matter on Thursday.

Some such as Rep. Sue Myrick (an early stage breast cancer survivor) have written some supportive letters but none have so far used their oversight authority to bear on FDA's major misstep with Avastin.Let's encourage the Committee to fully engage on this issue.

ACTIONS REQUIRED FOR THE FDA SUBCOMMITTEE ON HEALTH WHEN YOU CONTACT THEM – PREFERABLY ON 7/5/11 & 7/6/11 (& IF NOT POSSIBLE THEN LATER)

FAMEDS will leave the message you wish to deliver up to you but will be pushing the following issues:
  1. What are these women supposed to do if FDA Commissioner Margaret Hamburg decides against Avastin? Go home and die?
  2. How can American women be ahead of the game in fighting breast cancer with fewer options to fight the disease instead of more?
  3. More than 40,000 women per year die from metastatic breast cancer in the US. We need to fight this disease, not retreat in this battle.
  4. The rug will remain available to women in the rest of modern medical world, meaning the US will be falling behind other countries in the war on cancer.
  5. Avastin is a unique drug and there are no substitutes. Women who need this drug will die if this decision goes forth.
  6. The Centers for Medicare and Medicaid Services (CMS) has issued ambiguous statements regarding Avastin, leaving patients and their physicians in uncertain territory regarding availability and coverage for Avastin. Without insurance coverage, and with the cost of Avastin at over $90,000 per year, the drug is unaffordable to all except the wealthiest Americans.
  7. The process that the FDA followed was not proper.
    1. The panel of a subset of Oncologic Drugs Advisory Committee (ODAC) members was not properly selected. It was drawn from the current ODAC roster, every member of which was handpicked by self-appointed cancer czar Richard Pazdur. Hence it was not independent of him, as contemplated under the law.
    2. Five of the 6 panelists had already voted against Avastin, spoken publicly against Avastin and were not going to change their votes. When asked why other experts could not be found, the FDA replied that they could not find anyone who was not biased on the matter! (The FDA has not described what, if any, efforts they made in arriving at that determination).
    3. No breast cancer experts were selected for the hearing panel – a major and apparently deliberate decision.
    4. A panel member in the July 2010 meeting had stated that whereas cost was not supposed to be considered, they all knew it was an issue. Why was this public statement not investigated by the FDA when it was contrary to their rules?
    5. The FDA asked the drug's manufacturer Genentech to show continued progression free survival in its trials. It did so, albeit on a reduced basis. Avastin should have been approved. Instead after the trials had been run, Richard Pazdur moved the goalposts and said that the magnitude of the original trial needed to be replicated, which was not the original requirement for approval. That the goalposts were moved by FDA was solidly established during the hearing, but the panel ignored that fact.
    6. The FDA refused to accept the existence of hundreds if not thousands of women and their oncologists who said that the drug is working for them. These so-called super-responders have been ignored and contemptuously referred to as "anecdotal evidence."
    7. Avastin has been used by over 800,000 patients worldwide for treating various cancers. It makes no sense that the drug is too dangerous for treating metastatic breast cancer, when it still considered safe enough to treat other forms of curable and incurable cancer. The greatest risk to these women is not being able to receive their Avastin.
    8. Avastin remains on the market for brain cancer, colorectal cancer, kidney cancer, and lung cancer. If it is not dangerous for these cancers, why is it so dangerous for metastatic breast cancer.
    9. The FDA rejected substantial evidence offered by practicing oncologists who specialize in treating breast cancer that there are super-responders to Avastin. Those oncologist, which include experts at leading NCI certified treatment centers, such as Fox Chase Cancer Center in Philadelphia, pointed out that some of these women had lived for over 6 years on Avastin with good quality of life, outcomes that far exceed the expected prognosis.
    10. FDA exaggerated the safety concerns associated with use of Avastin, which are uniform and well-known across the various cancers for which the drug is approved. All of the drugs approved for treatment of metastatic breast cancer have serious side effects similar to those posed by Avastin. All can result in a low incidence of treatment related death (generally about 1 percent), or severe side effects that require management and sometimes dose reduction or termination of treatment. The FDA was deliberately disingenuous and incomplete in its discussion of risks throughout its more than one year effort to rescind approval for Avastin, and also consistently understated both the risks of the disease (MBC is considered incurable posing a risk of death of near 100 percent) and the benefits of the drug – claiming that extended control of disease progression constituted no benefit at all. Many breast cancer oncologists, women who actually have the disease, the European Medicines Agency and the National Comprehensive Cancer Network disagree.
  8. Congress has failed to exercise proper oversight over this action by the FDA, and over the FDA's handling of cancer drugs in general.
  9. The voters will remember this in 2012.
  10. While Europe expanded access for Avastin on June 28, 2011, the FDA voted to shut it down. How is this possible that looking at the same data, Europe is going one way and the U.S. another?
  11. The National Comprehensive Cancer Network (NCCN) has affirmed its support for Avastin. This body consists of 21 leading U.S. cancer hospitals listed below. They issue evidence-based guidelines for cancer treatment that is followed in over 100 countries and often in the U.S.

    The NCCN includes: the City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center - Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Memorial Sloan-Kettering Cancer Center, New York, NY; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/University of Tennessee Cancer Institute, Memphis, TN; Stanford Comprehensive Cancer Center, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE; The University of Texas MD Anderson Cancer Center, Houston, TX; and the Vanderbilt-Ingram Cancer Center, Nashville, TN.
  12. Other cancer drugs such as Gemzar remain on the market for metastatic breast cancer and which are far more toxic than Avastin. This sort of comparative data was not allowed at the hearing on June 28th & 29th, 2011.
  13. The real reason for the unique reversal on Avastin is supposedly because the cancer czar Richard Pazdur does not like the accelerated approval system under which it obtained its approval. So he is killing Avastin to send a message to the pharmaceutical and bio industries that they are not to use this avenue for future drug approvals. This will slow approval of drugs in the U.S.
  14. Today Avastin, tomorrow the drug that you may wish for you or a loved one.
  15. The U.S. is losing its lead in the drug industry and more trials are moving offshore.
  16. How can an industry function when the regulated parties have no idea what is expected of them from the regulators? In the case of Avastin, the drug company thought it had met the criteria for approval only to be told that these criteria had changed. With this uncertainty, is it any wonder that drug companies will go elsewhere for their approvals before attempting to make it through the FDA's obstacle course?
WHOM TO CONTACT ON THE HEALTH SUBCOMMITTEE ON HEALTH

Please contact as many members as you can. You probably will not reach a member but leave a message for the health care aide and mention that the issue regards the drug Avastin.

Key offices to call are those of Fred Upton and Joe Pitts, as they are extremely influential.

(**Click here to view the contact information**)
 
 
Avastin Fight Song


Composer and performer, Andrew Katz, NYC

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