New Useful Information

Thanks to all of you that have reached out to me after seeing the news coverage this morning.  My email was full of important messages from various people, some from far away.  I have learned the information that I have been searching so hard to find.  So here it is:

Genetech, the drug manufacturer of Avastin has until this Tuesday to submit an appeal to the FDA.  Once the FDA receives that appeal, then they will decide whether or not to grant Genetech the requested hearing.  The FDA does NOT have to grant Genetech this hearing.  If the FDA does allow Genetech to appeal this case, then this will become the 1st hearing EVER that the FDA will conduct.  Essentially this is uncharted territory in the history of the FDA.

It is my understanding that the FDA has 30 days to decide if they will allow Genetech the opportunity to be heard publicly to the FDA.  If the FDA decides to grant Genetech this appeal, then this appeal will be registered in the federal registry and will become public knowledge.  I believe that the public would be allowed to listen in to the appeal, but only 3 reps from Genetech would be allowed to speak.  The FDA will form an advisory committee that will be allowed only to ask questions and the final decision will be made by the 13 members of the FDA board.  The decision does not have to be made on the day of the hearing.

If the FDA continues with their efforts to stop approving the drug "Avastin" to stage 4 breast cancer patients, then Genetech can appeal to the go thought the US Court Systems.

So, there you have it, that is what will be taking place in the month to come.  What can we do?  Write letters of concern to our elected officials that hold positions in Washington.  Express your concern for our health care to remain an issue between the doctor and patient, not the US FDA.  The FDA says that one of the reasons that this drug is being recommended to be off the market for breast cancer is the dangerous side effects.  Today, I spoke with people of great knowledge on this subject just to see if the side effects were any different in breast cancer patients on Avastin than the other 4 types of cancers that are administered Avastin, but aren't at risk of loosing the drug.  The reply was as I expected, common sense, all patients taking Avastin have the very same serious risk factors.  Absolutely no different in breast cancer patients than any other.  Same potential deadly side effects.  My question now is, how can this become a deciding factor if it is not an issue with all of the other cancers treated by Avastin?  I don't see where this can hold much weight in their efforts to pull this drug.  So, they say cost doesn't have anything to do with this, and I say the side effects can't really play much into it, since they are only targeting breast cancer patients to no longer take the drug.  What's left?  Time.  How can they make a decision for the 17,000 women that are taking Avastin as their line of defense to fight this disease.  How can they tell them that this drug hasn't proven to prolong your life long enough.  What is long enough?  How can a patient know how long the drug may or may not work if they aren't allowed to have the drug.  This drug has worked well for me for 2YEARS!   I know there are hundreds out there just like me!!  What about the women that have gone down the entire list of targeted therapies with little choices left, should they not be given the opportunity to give this drug a chance.  We aren't asking for much.  We simply want all therapies that have any benefits whatsoever to remain available as a weapon to fight.  Two weeks of extended quality of life can make a lifetime of difference to the people that are left behind.  No one has the right to decide how long is sufficient time for one to continue to live.  This is immoral.  It amazes me that we as Americans are allowed to take a life in the beginning stages through abortion, but we may have our hands tied and not allowed to extend our lives because someone panel of 13 professionals say that the studies don't show significant extension of life.  Bottom line...This country needs GOD back into it.  We have been quiet to long, and this beast has crept up on us and will start snowballing on all of us if we as Christians don't start standing up to our government and voicing our opinions on what is right.  Deciding how long an individual can benefit from a drug to make it available to them is WRONG!!

Please write any senator, representative, congress and FDA members and let them know where you stand.  We have elected these people to be our voice, now we need to let them hear the voices!!

Thank You All!!

God Bless!