Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: Michael Greene who wrote (1680)	1/26/1999 7:31:00 AM
From: BMcV	Read Replies (1) \| Respond to of 10280

more on Meridia, Worth feature from agfinder on Yahoo: worth.com Skim to "Day 18" for facts if you don't have much patience for journalistic fluff. How are things in Winchester, Michael? Here's an excerpt: >> How did Meridia ever end up on the market? According to study after study, I read, Meridia is only moderately more effective at causing weight loss than a placebo. (So moderately that FDA scientists, describing the drug, were moved to outright irony, repeatedly putting quotation marks around the word "effective.") And, according to study after study, there is worse news: The drug has such profound and potentially dangerous side effects that FDA scientists twice recommended it for non-approval. The main worry was that sibutramine seems to induce high blood pressure and increased pulse rates, particularly at night, when both these measures usually decrease. After reviewing more than a dozen studies, the reviewers concluded that Meridia is a paradoxical drug: While it may help people become less obese, it does nothing to eliminate- and may actually increase-many of the obesity-related illnesses that make obesity so dangerous, which is why you are taking the drug in the first place. in other words, a perfectly healthy fat guy might lose weight with Meridia and in the process get less healthy. There is another worry: The government, the drug company, the researchers, and the scientists are still not quite sure what sibutramine is. Dozens of NDA pages are given over to a debate about whether the stuff chemically resembles amphetamines (like the old-fashioned "bennies") or hallucinogens (like the recently popular street drug MDMA). After finally concluding that it is neither, the report presents a detailed argument about whether or not Meridia causes addictive behavior. Unfortunately for Mother Nature, resolving this issue required the cooperation of many members of the animal kingdom. in a test substituting Meridia for cocaine, several lab monkeys dosed themselves silly with the stuff. At least one died, and several others became so sick with blood in their urine that researchers had to terminate the experiment. The finding this time was conclusive: Sibutramine was classified a Schedule IV drug- It's a controlled substance. To Knoll's chagrin, the label for Meridia must carry the very uncheery "Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely...." Nevertheless, Meridia won approval. in return, Knoll promised to eliminate the 20-milligram version of the pill, which had prompted the most pronounced health concerns. The company also promised to carry out an extended series of post-marketing follow-up tests. But my reading of the document leaves me wondering, as it did one prominent FDA scientist, whether sibutramine has "an unsatisfactory risk-benefit ratio." <<