[chrisy]

All of these ideas are great. With Pinktober just around the corner, there should be opportunities to generate conversation. However, that is a month away... When placed in context with the FDA's pending decision on Avastin, it's clear to me that the voices of both metastatic bc patients and Her2+ patients are not being heard.

I suggest, based on some conversations I've had in the past day or so, that if we want to have impact we need to act now, while the issue is "fresh". And continue to keep the volume up after that.

The most immediate impactful action we can take is to individually, as a group, and in concert with others (the outreach to Komen and other groups with interests in common) is to write to the FDA, copy our representatives in Congress - as well as those with aspirations to become our congresspeople and senators.

Who remembers the end of Miracle on 34th street??? Our response needs & deserves the "put it here on my desk" treatment. Since we probably won't be invited, we'll have to put it there ourselves - via email, snail mail, fax. But just as many bags. Again, they need to hear our voice.

I agree with I think Brenda's comment; we must be succinct and factually accurate; but the issue is not only a scientific one, it is a perspective.

Let's hear it - what are the salient points we would need to include in such a letter? If we can design a basic format then we can pass it on and people can send, amend, personalize or whatever...

Here are a few points (NOT succinct, yet!) we might be able to use:

We are Stage IV breast cancer patients. We have benefited from TDM1 or need access to TDM1 because we are running out of options or want options that offer good QOL. Our need is now...not 3 years from now.

We are Her2+ breast cancer patients. Science is moving very fast towards targeted and personalized treatment. Her2 overexpression in BC became a prime therapeutic target, with game changing results.

We are asking the FDA to consider the unique needs of the metastatic breast cancer community, and the Her2 cancer community. (how many people IS that, anyway?)

For people living with metastatic disease, it is important to have options. (what does that mean for you?)

Options that enable us to live more fully and with greater quality of life are a big deal. Phase II studies indicate TDM1 has a low incidence of significant side effects, especially compared to traditional chemo. Although I'm just a single datapoint, I personally have enjoyed great QOL on TDM1

Time is also a big deal - what Stage IV patients need MOST is faster access to therapies that can extend life and improve quality of life. True, we don't want to sacrifice good science on the alter of expedience - but more importantly, we mustn't sacrifice LIVES on the alter of caution. Stage IV patients simply cannot wait.

Emerging science is our best hope and tailoring therapy to the individual's disease is key. Requiring patients to run the gauntlet of "one size fits all" therapies as a precondition to try the "custom made therapy" seems completely the wrong direction.

The approval process needs to keep up with the science.



What have I missed? (I deliberately left out any personal opinions and tried to be rational - after all if I'm trying to influence someone at the FDA I'd rather have the letter actually have a chance of being read!)

If you've already written, or are writing a letter could you share it here?