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Biotech / Medical : Eli Lilly -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (123)	4/6/1998 10:08:00 PM
From: LoLoLoLita	Read Replies (2) \| Respond to of 642

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

To: Anthony Wong who wrote (123)	4/7/1998 8:22:00 AM
From: lazarre	Read Replies (1) \| Respond to of 642

Anthony: Re: CNN Actually, it was Dr. Steven Goldstein who was introduced at the start of the show as being connected with Lilly. The woman was from the National Cancer Institute and the other guy was a doc/academic. My take on it was this: tamoxifen ( on the one hand ) was truly a watershed for women who had and feared breast cancer. On the other hand there were enough potential side effects ( particularly the chance to incur uterine cancer ) that you really had to think twice about embarking on a treatment program. Ok. Heres where it really got good: Goldstein was asked at the end of the show if he would recommend to his wife or mom-in-law- tamoxifen. I paraphrase from memeory here: maybe, but why not prescribe ( of course when available ) the new generation of serms that not only was an estrogen blocker for the breast but the uterus as well. Here it was mentioned for the second time during the program: raloxifene. Which of course is Evista ; I don't think Dr. Goldstein or any other doc could mention Evista by name ( anyone out there care to enlighten us about that?? ). All agreed that raloxifene was a ways off but I sense not that far away; what with the news going to snowball into critical mass regarding tamoxifen and the associated news about a similar drug without, perhaps, the harmful side effects. Note how an active lobby succeeded in pushing for aggressive FDA approval of drugs to treat HIV. Here you have a more socially acceptable vested interest group ( 135 million women ) going to do the same thing. I think that when Lilly went exploring for gold with Evista they had no idea it was going to turn into a diamond. Just my opinion. Lazarre

To: Anthony Wong who wrote (123)	4/7/1998 9:01:00 AM
From: Henry Niman	Respond to of 642

Raloxifene was mentioned in several reports, including C-SPAN which covered the National Cancer Institute news conference. Raloxifene (Evista) is slated for a head to head prevention trial with Tamoxifen. Placebo participants in the previous prevention trial will be offered enrollment in the new trial in which they will be randomly assigned to receive Tamoxifen or Evista. There are several reviews on SERMs linked to home.att.net There is also an older Wall Street Journal review at: home.att.net