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To: gg cox who wrote (13747)	10/16/2004 11:26:41 AM
From: Joe Krupa	Read Replies (2) \| Respond to of 14101

Thanks for posting that, gg cox. "Regulators in Europe are expected to make a decision as soon as next week about whether to take any action on the drugs. The F.D.A.'s expert panel will review whether Celebrex and Bextra are safe, Dr. Sandra Kweder, acting director of the administration's office of new drugs, said in an interview yesterday." Wow, next week could be a significant week for the stock price of DMX if Europe makes any kind of decision to broaden the CoxII ban. I'll be watching the newswires vigilantly. "While no study of either drug analyzed by the agency so far has been cause for concern, Dr. Kweder said, the agency is not sure it has all the information it needs. The agency is aware of the two studies involving the intravenous form of Bextra, but "it's unclear what the relationship is with the oral form," she said. Other recent studies suggesting that all COX-2 inhibitors may have safety problems are still being analyzed by the agency, she said. Uncertainty over the safety of drugs is not uncommon, Dr. Kweder said, and that is "something we have to take into account with regard to every decision we make about marketing a new drug and every decision we make about withdrawal of a drug." But some doctors say because the benefits of COX-2 drugs are so unclear, the advantages of taking one of these painkillers may not outweigh these risks. "You have to treat people who are high risk conservatively," Dr. Campen said." Certainly the story is far from over in the US as well. Sounds like a few skeletons may still be in the closet there. The world continues to look better for Pennsaid. joe

To: gg cox who wrote (13747)	10/17/2004 4:42:39 PM
From: axial	Respond to of 14101

Hi, gg - It's been long understood by Dimethaid investors that Pennsaid avoids most of the dangers of ingested NSAIDs and COX2 selective inhibitors. Remember this? pennsaid.ca And this? Topical Solution for Osteoarthritis May Challenge COX-2 Inhibitors pennsaid.ca ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ The difference between then and now? We're getting proof of how correct these beliefs were. After a promising start, Pennsaid sales levelled off. It was believed by some that Pennsaid sales would continue to grow, but the lack of evidence (many health-care agencies such as NICE in the UK have an evidence-based approach) was a flaw. Sure, you could "pitch" Pennsaid on the basis of a rational argument that the ultimate cost of using Pennsaid was actually less than pills. Why? Because you didn't incur the additional costs (to the health-care system) of treating side effects. But where was the data? There was none. The rational argument (by itself) wasn't enough to persuade many physicians, or formularies. Over on SH, we were continually bombarded by quotes from the Glasgow formulary, that rejected Pennsaid on the basis of cost-effectiveness. That, coupled with the bias against topicals for OA (especially in the UK and EU) - and the difficulty of differentiating Pennsaid from other topicals - meant that Pennsaid's acceptance would be slow, at best. There's lots of built-in inertia in public health agencies. Nevertheless, affirmation of data from Pennsaid trials, and new awareness of side effects of pills means new sales for Pennsaid. How many? How fast? That will depend on how much "inertia" there is, and how well new management can improve marketing of the product. At some point, one has to believe that Pennsaid will be much better understood as a very strong alternative to, or adjunct of, pills - and the best of all topicals for OA. Regards, Jim