[Chelee]

Chris,
Yesterday schoonder posted a message from a blog down in the "Articles of Interest" forum that some might be interested in reading? I hope schoonder doesn't mind me adding it up here? Obviously Genentech is feeling the pressure and being swamped by calls for T-DM1. Here is "schoonder" post below.

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Easier access to the drug?
Posted yesterday on assertivecancerpatient blog.
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'The Straw That Broke the Camel's Back'

Dr. Lee called me at about 1 this afternoon to report on his phone call with Dr. Sandra Horning and Terry Rugg at Genentech.
One thing he said is that he thinks my asking to get T-DM1 on compassionate use was "the straw that broke the camel's back," because Genentech has been hearing from so many women recently who are in my situation: they could be helped by T-DM1, but they can't travel to the nearest clinical trial site.
(Remember, there are only 12 phase II trial sites, and there were supposed to be 20, including one in Seattle at the University of Washington Medical Center--that one never opened.)
I assume that the folks at Genentech were discussing the issue before I came along, otherwise I don't think they could have come up with a solution in 48 hours--which is the amount of time that has passed between Dr. Lee's first phone call with Genentech on Wednesday and today's call.
Not that I'm not delighted to have been that straw, if that was indeed the case. My friends may call me "Straw" now and in the future.
So, this is what they told Dr. Lee:
* Genentech is--or has been--working on a broad program for local delivery. (Translation: I could get T-DM1 at Dr. Lee's office. No more traveling to S. California every three weeks.)
* One piece of this will be demonstrating the drug's safety for the women who get it at their local oncologist's office.
I'm not quite sure what that involves, but proving that the drug is safe for me is a cake walk--I got the drug for seven months with no serious side effects of any kind. Any problems I had during that time were not caused by the T-DM1, except that my platelets did drop, but never low enough that Dr. Ibrahim had to cut my dose. And certainly not low enough to put me in any danger.
Also, let's not forget that I am in remission for the first time in years--five or more, I believe--because of the T-DM1.
* Any hospital or cancer center that wants to offer this to their patients will have to do an IRB. I don't know much about IRBs, except to say that these are review boards within a facility that have to approve the plan. Sometimes this can take time.
* Doctors such as Dr. Lee and their cancer centers or clinics will have to be approved and then the doctors will be added to the trial as principal investigators.
* The FDA will have to approve Genentech's plan.
Next week, let's start lobbying the FDA and also the Congressional committee(s) that oversee the FDA.
* The timeline is about three months.
Now, this is amazing, but what am I supposed to do between now and then? My cancer could come back aggressively within the five months or so since my last T-DM1 treatment and the time this program is up and running.
* Dr. Lee thought of that, and asked about it. The answer: Genentech will allow me to return to the trial in Highland, California, even though I have broken the rules by skipping two (three by now, if not four) treatments.
That is truly amazing!
They did say I would have to get to Highland (Ontario airport) on my own, and they are faxing Dr. Lee a list of organizations that they think might help me financially. I'll get that list from Dr. Lee next week, but how much do you want to bet that I've already contacted most of them? I'm not expecting much help there.
So back to fundraising. Sigh. However, three months is only four treatments/trips, so about $4,000. I think I can raise that much.
I can't begin to say how happy this news makes me. I'm going to have a wonderful summer after all! And my life expectancy is pushed out another year, if not longer.
Thanks, Genentech.
And thanks to Dr. Lee. He put a lot of time into this, and he's going to put in a lot more before we have this plan in place. What can I say? He is the most wonderful doctor.
Read more: T-DM1
Feeling generous? See: My Cancer Travel Fund
@ Jeanne Sather 2011"