Proposed Next Steps Re: Improved access to important new types of drugs

[Guest guest]

I am encouraged by group members' interest in advocating for approval of

agents like CAL-101 and PCI-32765, and I want to participate.

I suggest this basic plan for our advocacy effort:

1. ANALYSIS. Understand the FDA approval strategy of the

manufacturers of these agents, Calistoga Pharmaceuticals for CAL-101,

and Pharmacyclics for PCI-32765. These firms would not undertake

multi-million dollar clinical trials without having a strategy for FDA

approval of the agents. Perhaps one of our medical advisors can make an

introduction to the appropriate official(s) within these firms. This

step will set direction for patient advocacy.

2. PLANNING. Coordinating with those firms, determine how our patient

community can help achieve approval of these agents, in the event

clinical trials continue to show promising results. This step will

identify near term and long-term advocacy activities, may include

coordination of effort with LRF or L & L, fund-raising, and letter writing

or lobbying campaigns including provision of templates, guidance, online

support tools, etc., perhaps by CIG. We should make it easy for many

members of our community to participate in this worthwhile effort by

providing the right tools. We should seek a high-profile spokesperson

who has CLL.

3. IMPLEMENTATION. Proceed with activities identified during the

planning stage, under the leadership of a small team from our community

I am not cathecting with this specific plan, but I hope to stimulate

discussion about an advocacy campaign for which I will invest effort.

Adam Irgon Princeton, NJ Dx Feb, 2006 at age 45; FCR-Lite April

through Sept., 2009; Currently CR

>

> Dr Furman's analysis of the FDA stance is frightening and will cost

> lives if not remedied.

>

> I am not sure how we attack the problem. Cost effectiveness might

> provide leverage if applicable. Less toxicity mean less costs,

>

> This issue should be moved forward, perhaps with a co-ordinated effort

> by Pharma, the research docs and the broader cancer community.

>

> We might get more traction if we linked up with the other cancer

> survivor communities (breast, colon, etc) that are more monied, have

> famous spokes people, and have more political clout.

>

> Anyway, these are my first thoughts on this, but I have no political

> sense of what really needs to be done.

>

> Reminds me a bit of our struggle with the CDC and the risk to CLL

> patients with live vaccines, but this is much bigger.

>

> I am willing to help however I can.

>

>

>