Tykerb/Lapatinib -- approval? who is using?

[Kaye]

I want to thank Joe and those who were at ASCO who helped get Tykerb / Lapatinib approved for compassionate use. I was wondering if there is anyone here who has been able to get it. Does anyone know of anyone who has had it approved for compassionate use?

I am getting an uneasy feeling about whether or not anyone is getting approved for it, even if they meet eligibility qualifications, as outlined in the brochure that GSK has written up. Several have written that they have contacted them but have not had any response. I know of at least one person who would have qualified for compassionate use who was told by a non-profit hmo that she could not get. I also asked my oncologist (non-profit hmo) and he quickly glossed over it and would not discuss.

If it has been approved for compassionate use, why are those trying to get it having such a difficult time? I am beginning to wonder if the program outlined for compassionate use might be bogus.

What comes to mind re. compassionate use programs is how many new drugs came about and were allowed to be used by aids patients. Almost any medication developed for aids won fast track approval. Those with aids can get almost any medication either for free or for a very small cost (50 cents/dose). Because of this aids is no longer considered a death sentence. Is this not discrimination?

It is true that those of us who are Her2 are now allowed Herceptin. But are we? I hope I am mistaken but read that those who have advanced stage IV and have received other treatments previously are not being allowed to have it? Thus, if that is the case, then they are not even being allowed Lapatinib. because they have not yet had Herceptin. By definition should compassionate use include all the above? Why aren't patients who might benefit from Herceptin being allowed to have it for compassionate use--or is that being done? And, if not allowed Herceptin, and they are Her2+, why can they not get Tykerb?

And, if Lapatinib is as effective and safe as studies claim, why is it so hard to get? Shouldn't we be allowed to try it before using more toxic regimens?
Is it a cost concern--is it too good? Would it bring about economic disaster to other pharmaceutical companies if it works so well that patients don't have to use the other, more toxic, and very costly drugs?

Also, if someone was on Herceptin and only given it for one year (because of insurance limitation), why can't they use Lapatinib if it is theortetically safe--at their own risk of course, based on current available information?

What can be done to speed up the process of those who might possibly benefit from Lapatinib gaining more easy to it?