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


To: Doc Bones who wrote (4318)7/14/2001 10:50:57 AM
From: Biomaven  Read Replies (1) | Respond to of 52153
 
Where's your test data on aspirin, huh?

chuckle.

No way in hell the present FDA would ever approve aspirin - even low-dose aspirin:

Gastroenterology 1999 Jul;117(1):17-25

Comment in:
Gastroenterology. 1999 Dec;117(6):1505
Gastroenterology. 1999 Dec;117(6):1505-7

Effects of very low dose daily, long-term aspirin therapy on gastric, duodenal, and rectal prostaglandin levels and on mucosal injury in healthy humans.

Cryer B, Feldman M.

Medical Service, Dallas VA Medical Center, and Department of Internal Medicine, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA. bcryer@mednet.swmed.edu

BACKGROUND & AIMS: The safety of low-dose daily aspirin therapy in the gastrointestinal tract is uncertain. Our objectives were to evaluate the long-term effects of very low daily aspirin doses in the gastrointestinal tract and effects on platelet-derived serum thromboxane levels in volunteers. METHODS: Subjects were randomized to receive 10 mg (n = 8), 81 mg (n = 11), or 325 mg (n = 10) aspirin daily for 3 months. Before administration of aspirin, all subjects underwent gastroduodenoscopy, and most underwent proctoscopy for assessment of mucosal injury and prostaglandin content. After 1.5 and 3 months, subjects again underwent gastroduodenoscopy and, at 3 months, another proctoscopy. RESULTS: Each aspirin dose (even 10 mg) significantly reduced gastric mucosal prostaglandin levels, to approximately 40% of the baseline value. All three doses also induced significant gastric injury, and 325 mg caused duodenal injury. Three subjects developed gastric ulcers, 1 while taking 10 mg/day of aspirin. Furthermore, aspirin at 81 mg/day and 325 mg/day (but not 10 mg/day) significantly reduced duodenal mucosal prostaglandin levels to approximately 40% of the baseline value. Only 325 mg of aspirin per day significantly reduced rectal mucosal prostaglandin levels to approximately 60% of the baseline value. Serum thromboxane levels were inhibited 62%, 90%, and 98% with 10, 81, and 325 mg of aspirin. CONCLUSIONS: The findings explain aspirin's predominant gastric toxicity and question the safety of even 10 mg of aspirin daily.


Now that's a 10mg dose they are talking about, not the 500mg dose people take for headaches. Incidentally, I've been told by a doctor that you can detect the residual hemostatic effects of taking a single dose of aspirin over a week later.

Peter

BTW, on Synthroid the best play would be King Pharma. It's kind of a long shot that the FDA would really take Synthroid off the market, but in their present mood who knows. King isn't cheap at all, but they do have a fantastic drug in Altace.