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

To: Andrew Cooke who wrote (27988)	2/7/1999 7:47:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Andrew, thanks for the input. I'm not a lawyer nor an MD, but the off label aspects of the phen-fen suits appear to me to be somewhat fabricated. A great deal has been made that use of the combo is an "off-label" application, since each drug was tested and approved as mono-therapy. However, it appears that it wasn't the combo that produced the heart damage, but the one drug in and of itself. Patients that just received Redux (the chirally pure form), also had heart damage when taken alone. Thus, if Redux was used "on-label" as mono therapy for weight reduction, patients still experienced the side effect of heart valve damage. So far, the data that I have seen implicating the "off-label" combo, has been very weak.

To: Andrew Cooke who wrote (27988)	2/7/1999 8:12:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Without getting bogged down in whether the heart damage associated with phen-fen was true a problem associated with off-label usage, I think that the likelihood of a law suit for off-label use falls back into the familiar "risk/reward" area that is associated with virtually any drug trial, approval or use (even in a pilot study). Even when drugs are used "on-label", there is a certain risk associated with the use. In the case of LGND's drugs, which are approved for cancer, its not that hard to justify the risks of using the drug, because the risk of not using the drug is so high. Off-label use for cancer is rather common because of this risk/reward ratio. Unfortunately, many patients fail various cancer treatments, and a failure to treat with alternative treatments will frequently lead to a rapid decline in health. I believe that Targretin is already used on a compassionate basis, even though it has not been approved for anything. Since Panretin and ONTAK are now approved, I expect their off label use for treating patients with various advanced cancers will be among the first off label uses, and I seriously doubt that the likelihood of a law suit would be much high for off label use than on label use for patients with advanced cancer who had failed prior treatments.