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Pepin’s Pharmaceutical Prattle
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01-23-2006 Quote of the day: Let the fear of danger be a spur to prevent it; he that fears not, gives advantage to the danger. Francis Quarles (1592 - 1644)
High Gear-No Fear One former neighbor child has a guardian angel with a bent halo. "Michael" was always about 1 inch from death or dismemberment whenever he stepped out of the door. One day he road his "BIG WHEEL" tricycle off of the lip and into the deep end of our concrete, in-ground, almost empty pool. After falling 8 feet into 2 feet of water he surfaced with a very surprised look on his face told me in no uncertain terms that “people should not be allowed to have pools in their bakyards!” Jaded by years of Michael’s messes, his mother was more upset that he had sat down on the ground under the bird feeder after getting soaked and thus resembled a large Salted Nut Roll that she did about his near death experience. It would not surprise me to find out that "Michael" has found his way into a prominent position in the FDA. When it comes to drugs and regulations sometimes I wonder if they grasp the reality of life outside of the beltway. Patients need access to new drugs for old diseases that are under treated and bureaucratic delays, physicians do not read all of those black box warnings, patients do not read "patient package inserts", health care professionals, do not generally report adverse reactions that can be found in the package insert (even though all should be reported), and January is a lousy time to start ANY kind of drug benefit plan. Let's hope that the FDA's guardian angel is just as good as "Michael's" and that everything turns out fine. =================================================== ps. Best answer this week to the question "How are you?" was "OK....sometimes OK is a good as can be expected"
pps. Occasionally, some of the links require FREE registration.... I'm sure you can handle THAT slight inconvenience.
==================================================== 1) Minnesota hold 'em Boston Scientific goes "All in" (backed with debt) but is called by J&J (sitting on a big pile of cash). Looks like J&J will walk away with Guidant. Smart money is that Boston Scientific will acquire another Minnesota medical device company as an alternative. http://www.newsmax.com/archives/articles/2006/1/13/214405.shtml
2) WHO: Do not pooh pooh dodo doo doo H5N1 (bird flu) virus can live for a month in bird droppings. Not great news for those MILLIONS of us who do not want to become infected. In cold weather (like Minnesota for part of the year) its 30 days,,, but 1 week in hot climates (like Arizona for part of the year). Expect Colonel Sanders to start raising his fowl INDOORS ONLY and away from wild birds if this jumps the pond.
3) Brazil nuts! Dietary supplements from Brazil contain Librium (like Valium), Prozac, and the unapproved stimulant, fenproporex, which is converted to amphetamine in the body. http://www.fda.gov/bbs/topics/news/2006/NEW01298.html
4) Despite the January turmoil…more enroll in Medicare Part-D Anyone who has ever been associated with a pharmacy benefit knows that January is TURBULENT (at best) and expectations should have been managed. If you know of someone who needs help find the best plan for themselves or a loved one have them go to www.ElectRx.com . Selection is optimized for the patient; not the pharmacy, not the drug companies, and not the insurance companies. It may cost them a little money for the help but unbiased help selecting the best plan has saved some patients $1000's.
5) FDA changes package inserts forever! Drugs approved in the last five years and new drugs will be the first to comply. When will the FDA realize that doctors do not READ the package labeling. They go to it when they have a specific question. I don't expect that making it easier to read will help. (and patients do not read what they are given right now,,,,eet alone anything that will be OFFICIAL Patient Counseling Information. (I could be wrong… and I hope so) http://www.fda.gov/bbs/topics/news/2005/NEW01272.html
6) Not your father's 'limus. Topical drugs may cause cancer. FDA adds BLACK BOX warning to Elidel and Protopic drug labels. These two prescription drugs were used against eczema and other dermal maladies. Now relegated to second line status. http://www.thestreet.com/pf/stocks/biotech/10262845.html http://www.fda.gov/cder/drug/infopage/elidel/default.htm - Pimecrolimus http://www.fda.gov/cder/drug/infopage/protopic/default.htm - Tacrolimus
7) FDA asserts drug claims belong in federal courts. Expect states who think that they won the lottery every time a citizen (who would pay taxes on the money in their state or spend it in their state) sues a drug company in state court with state citizens as jurors. (You have to admit that some of the recent rulings have been "over the top".) This is a battle worth watching. http://www.washingtonpost.com/wp-dyn/content/article/2006/01/18/AR2006011802320.html
------------ Have a SUPER-FANTASTIC week. Steve Disclaimer: "Pepin's Pharmaceutical Prattle" (AKA "The Prattle") is the property of PHARMWORKS, LLC and Steven M. Pepin, Pharm. D, BCPS. The opinions expressed are those of the bald-headed author. To start or stop any drug without the advice and supervision of your physician would be stupid. So don't do anything based upon what you read here without professional advice. To be added to or removed from the distribution list please e-mail your request to spepin@pharmworks.com . All insightful comments from readers are thoughtfully considered (the rest are callously discarded). Copyright 1998-2006 PHARMWORKS, LLC all rights reserved. --------------------------------------------------------------------------------------------------------------------------------------------------------------------
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