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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: DMB who wrote (22810)	6/28/1998 8:03:00 PM
From: Henry Niman	Respond to of 32384

DMB, Welcome to the Ligand thread. I appreciate your attempt to get some meaningful dialog going with some of our frequent posters who add many posts but not much useful info. I suspect that Fugazi will be hard pressed to come up with specific examples. The FDA takes a lot of flack, but they have a huge responsibility which will surely grow in the near future. Although I'm sure that there is some room for improvement in the time line for approval, clinical trials do take quite a bit of time and money, and that's just the way it is.

To: DMB who wrote (22810)	6/28/1998 11:04:00 PM
From: Hippieslayer	Read Replies (1) \| Respond to of 32384

First one that comes to mind is Thalidomide-which I believe is the drug that caused birth defects in pregnant women. But I must correct myself that the FDA has kept drugs in limbo or prolonged the approval where they might have helped patients where other conventional therapies failed. In recent, though, the FDA has loosened their noose to allow more patients to get access to experimental drugs. All you need to do is look to europe or canada which doesn' require as much as the FDA. I don;t know the statistics, but do eupropeans have a higher death rate due to drugs being poorly tested and being approved too quickly than in the US?

To: DMB who wrote (22810)	6/29/1998 1:11:00 AM
From: Robert L. Ray	Read Replies (2) \| Respond to of 32384

>>>As a physician, I am curious what drugs, in your perception, have been kept off the market to the detriment of the public?<<< The question wasn't directed at me but I know of one for sure. Duramed (DRMD) last year had their generic version of Premarin turned down in what has to be one of the most outragous actions the FDA has ever taken. The FDA laid out the ground rules for approval of the DRMD drug. DRMD met all the requirements. And in the 11th hour AHP apparently lobbied the FDA and said hey wait a minute... Premarin has some ingredients in it that the DRMD drug doesn't. That was true. These ingredients are actually inactive contaminants in Premarin. Never the less this gambit by AHP worked. It's of course widely suspected that the whole fiasco was politically motivated. (Especially by DRMD and ex-DRMD shareholders:) At any rate this is one example where the FDA has royally screwed up to the financial detriment of the American public since the public would have saved millions with generic Premarin.

To: DMB who wrote (22810)	6/29/1998 11:17:00 PM
From: Proton	Read Replies (1) \| Respond to of 32384

Re: The Two-Front Drug War (Looking for LGND info? Don't bother...) As a physician, I am curious what drugs, in your perception, have been kept off the market to the detriment of the public? First, the standard LGND-thread caveat: I have a life, therefore I do not try to read all of the posts on this thread. No flames for repetition, please. O.K., here goes: Let's clarify this "kept off the market" point. Two persuasive gripes (among many) about the FDA: 1. The approval process takes too long, costing lives while the bureaucrats grind through the minutiae of an NDA. The Wall Street Journal used to cite a heart drug (the name of which escapes me). They calculated that hundreds of thousands in the target population died during the period from NDA filing to final approval! 2. Safety and efficacy rules are not properly balanced against the condition of the target population for a drug (toxicity to advanced AIDS patients, for instance). While I am not one to support the FDA in any way, shape, or form, legislative relief over the past decade has ameliorated these two situations a bit. As we've learned with ONTAK, the agency can play plenty of games with the patient relief legislation (e.g., stopping the six-month clock at six months minus one day). Here are two responses to your question: 1. As a physician, do you believe there was never a time that a drug could have helped a patient of yours, but for the fact that it was not approved for use? If you are a pathologist, please disregard this question. :-) 2. I don't want to lay this all on the FDA, but I have a simple answer to the "kept off the market" question: MARIJUANA! I shan't even bother to elaborate on this, because just thinking about Federal marijuana policy makes me madder than the signal/noise ratio on this thread. Pý p.s. to the person who asked about my opinion on LGND technicals (oops, sorry to drift on topic): Besides waiting for five-month cycle to assert itself, and the obvious support at recent lows, I have no opinion at the moment.