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Pepin’s Pharmaceutical Prattle for 07-30-2007
Quote of the day: Yesterday I was a dog. Today I'm a dog. Tomorrow I'll probably still be a dog. Sigh! There's so little hope for advancement. Charles M. Schulz (1922 - 2000), (Snoopy)
Good morning ! Dog Days The "dog days of summer" were named after the dog star, Sirius and were though by the Romans to be an evil time "when the seas boiled, wine turned sour, dogs grew mad, and all creatures became languid, causing to man burning fevers, hysterics, and phrensies" (from Brady’s Clavis Calendarium, 1813). The dog star appeared in the northern hemisphere at dawn and was thought to be responsible for the heat of summer. Today we understand the science better but the days are just as hot. Unwatered grass is sharp and brown, unprotected skin is hot and red, and unpaved roads are dust. This is also the time of year that high school through professional sports training camps begin for soccer and football. Back in 2001 Korey Springer, a Vikings lineman, died of heat stroke. Heat stroke and heat exhaustion are not the same. With heat exhaustion the skin is cool and moist, subject is sweating profusely and feels faint, weak, thirsty and nauseated; headache may be present. Core temperature is usually more than 100 degrees (F). Heat stroke presents with flushed, hot, and dry skin as well as dizziness, confusion or delirium. Blood pressure may be high or low depending on the progression. Core temperature at or above 105 degrees (F). As I read it, short of having a rectal thermometer and blood pressure cuff, the discernable difference is skin moisture. You can more each to a cooler place and hydrate (no alcohol or caffeine) both heat exhaustion and heat stroke but the later is a MEDICAL EMERGENCY and an ambulance should be called. The best treatment, however, is prevention by maintaining adequate hydration (If you are not making urine then you are not drinking enough) and rest in cooler places. Any coach that belittles or chides players for taking it easy in the heat should not be coaching. Take care of yourself. Stay cool! =================================================== ps. Best answer this week to the question "How are you?" was "Hot and tired but I go home in 30 minutes...good!" a nurse at end of shift. pps. Occasionally, some of the links require FREE registration.... I'm sure you can handle THAT slight inconvenience. ------------
1) D-day for Avandia is TODAY! If science rules then it will stay on the market. If politics trumps science then it will be pulled. Reality is that the panel will see that both sides win by letting it stay on the market but with restrictions, including the dreaded “Black Box”. http://www.reuters.com/article/marketsNews/idUKN2645136920070726?rpc=44
2) Zelnorm out of the woodshed Zelnorm can once again be used. The kicker is that the patients have to be female and under age 55 and pass criteria. I don’t expect to see a resurgence of DTC advertising but …. I could be wrong. (http://www.zelnorm.com/index.jsp ) http://www.fda.gov/bbs/topics/NEWS/2007/NEW01673.html
3) One pop over the line… It appears that drinking more than ONE soda (pop, Coke) a day is associated with the development of metabolic syndrome. Doesn’t make any difference if it is sugar free or not. Metabolic syndrome consists of high blood pressure, elevated levels of triglycerides, low levels of the artery-protecting HDL cholesterol, high fasting blood sugar levels and excessive waist circumference. I can’t find it right now but I saw an article about 15 years ago that linked the carbonation in soft drinks and carbonated water to increases in triglycerides. If I find it…I’ll pass it on. http://www.healthday.com/Article.asp?AID=606621
4) Here’ another HOT FLASH….and another…and another Pristiq approval for menopausal symptoms (hot flashes) has been delayed by the FDA. More data about potential cardiac and liver problems. The drug, desvenlafaxine, is a congener of the antidepressant, venlafaxine. The company was to pursuing a depression indication also but the side effect profile could kill all potential approvals. http://www.reuters.com/article/marketsNews/idUKN2442193420070724?rpc=44&pageNumber=2&sp=true
5) Elevess rocks around the clock… feelin’ no pain. FDA approved a new cosmetic face wrinkle filler. The company added lidocaine (like NOVOCAINE) to the product so injections would be “more satisfactory” (ie hurt less). Sort of like BONDO used in auto body work but administered in smaller doses through a fine needle. (My old 64 Chevy weighed about 30 lbs more than showroom condition… prettier but heavier)
6) Floats like a butterfly; stings like a B(lockbuster) Sales of Alli, the otc version of Xenical, are taking off and should surpass Xenical sales soon. Hint: eat less fat and you don’t need the drug. Super hint: for those of you who use the drug and still eat a lot of fat… you better stock up on the Charmin. http://www.reuters.com/article/marketsNews/idUKL254493120070725?rpc=44
7) Last ditch effort for those in the last ditch Terminally ill people have sued the FDA for virtually unlimited access to any drug passing Phase I clinical trials, the trials that try to establish non-lethal dosages. The drug does not have to have any evidence of working…. it just has to be. This type of “compassionate use” is really “cruel and unusual”. Patients are unlikely to benefit while exposing themselves to unknown side effects. Even if there are provisions to protect the drug companies for litigation it will not protect the drug company from delays in application process when people taking their drug die (you did catch the part about “terminal” patients). A constitutional right?... more like a constitutional wrong! http://www.businessweek.com/print/technology/content/jul2007/tc20070724_550192.htm
8) Hey Mister Postman is there a letter for me? Pharmacists and physicians (and others) who registered as providers can soon expect a barrage of mailings as the National Provider Database is released by CMS. Drug companies should be will to buy the lists in order to influence prescribing. Let me know if you signed up and your mailing increase. http://www.cms.hhs.gov/NationalProvIdentStand/Downloads/NPPES_FOIA_Data%20Elements_062007.pdf
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 1998-2007 PHARMWORKS, LLC all rights reserved. --------------------------------------------------------------------------------------------------------------------------------------------------------------------
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