Anthony,
ZEN's drug, tamoxifen citrate, is already FDA approved for
*treating* breast cancer, and the study today showed it
effective in *preventing* breast cancer. But negatives for ZEN
are that tamoxifen is off-patent in Europe already and coming
off patent in the U.S. soon, along with its very serious side
effects.
Evista is currently approved only for osteoporosis, and full
FDA approval for its use in preventing breast cancer is several
years away--if it occurs at all! But the consensus is
that *it should* have similar therapeutic properties as
tamoxifen, and it surely has a much better side-effect profile,
as evidenced by FDA's approval of Evista for osteoporosis
(an illness deemed much less life-threatening than breast cancer).
Now, I think it worthwhile to discuss off-label use. Osteoporosis
affects the same population who are at greatest risk of breast
cancer, older women. These women can go to their doctor today
and get scrips for Evista. If LLY shows clinical data next month
that Evista is effective in reducing breast cancer risks, any
M.D. is free to prescribe it to those who want it, provided they
follow the applicable ethical guidelines.
The conversation might go something like this.
Woman goes to doctor and asks about breast-cancer-prevention
drugs. Doctor tells her that there is currently no FDA-approved
drug available, but that Evista is a drug sold for osteoporosis
which has been shown effective in reducing breast cancer risks.
Woman says, really?, I'm worried about osteoporosis too, do
you think it would be good for me to take Evista?
Cheers,
David |
