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To: russet who wrote (8730)	2/11/2002 2:07:16 PM
From: Cal Gary	Respond to of 14101

Hi Russett, I understand your point from your other posts. You may have a point about long term exposure. But like all things it takes time to identify. NSAIDS have a history, its side effects (on a sub portion of total patient population using it for chronic pain) are well documented (GI bleeding and death) and therefore can be managed or avoided. Even with linkage to GI gut rot and death, NSAIDS are still on they market? Why? Given Pennsaid (and DMSO together) is relatively new and does not have the history. Anyone can and should project worst case out comes. So far, from 7 years of clinicals, Pennsaid has no reported adverse side effect and it has not been linked or implicated to any thing nasty. Of course not yet (your point) and only a small population. Anything is possible over long exposure, this alone, IMO should not stop Pennsaid from being approved and benefitting those who choose to use it NOW. I want to put into perspective and measure apples with apples. To set this up, consider the following. I'll list some possible outcomes for using Pennsaid over a long constant exposure for chronic pain. You can add more or correct. Define long term exposure? Tylenol has been around 50 years, aspirin I guess is much longer. I pick to use 50 years. So if after 50 years on the market Pennsaid is found: 1. no change, no side effect or linkage to other indications. 2. minor side effect discovered. More than dry skin. 3. one major side effect discovered, equiv to GI Bleed level 4. multi major side effects discovered, equiv to death in small patient population 5. major side effect discoverd, equiv to death in large patient population 6. major side effect discovered, equiv to death and linked to other major indications ie cancer. Given Pennsaid provides 1 unit of benefit, at what point do regulators pull Pennsaid off the selves? Be fair, make it equivalent to oral NSAIDS.

To: russet who wrote (8730)	2/11/2002 7:33:44 PM
From: Mark Bartlett	Read Replies (2) \| Respond to of 14101

russett, How long were the Celebrex and Vioxx studies? Should studies with DMSO be held to a different standard? What indications is DMSO approved for in N/A? On Feb 9 you wrote: "When REK was asked the question, What concerns does HC have about the drug,...the answer she gave is that the concerns could be addressed by the data already submitted,...but she avoided answering what the concerns were,...why not answer if the concerns were so insignificant?" I responded: Why do you think? I never get your answer - or I may have missed it. Did you see this: wf10.com MB