Pepin’s Pharmaceutical Prattle for 06-02-2003
	Quote of the day: What we hope ever to do with ease we may learn first to do with diligence. Samuel Johnson (1709 - 1784), Lives of the Poets

Good morning! Celebrate! We celebrate the first Anniversary of the PPP online! Although published weekly (or weakly depending upon your point of view) since 1998 the web version is just now a year old. The diligence has paid off with loyal followers. In addition to our US friends (85%) we have readers from all over the world: Japan, Australia, England, Canada, France, Italy, Denmark, Greece, Switzerland, Brazil, Russia, Spain, Argentina, Taiwan, Saudi Arabia, Estonia and many more. We get hits from over 1300 separate hosts. We have 25,000 requests per month! With more diligence it may become easier for us to follow the pharmaceutical literature and forge ideas that you can actually use in practice. It has been fun finding new ways to entertain while educating and provoking thought (it is just the thought that is provoked…right?) Your feedback, suggestions and encouragement help to inspire and motivate. As they say …Keep those cards and letters comin' in… and I'll keep dishing up a weekly dose of Pharmaceutical Prattle.

1) Lipitor recall….

Counterfeit Lipitor was introduced to the retail market. Only certain lots attributed to one repacker are effected. Appears that the pills contain the active ingredient but some filler or different. The FDA may never track down the source but will make a good run at it. The surprising part is that this hasn't happened before this. Lipitor is the coin of the realm and king of the hill. Please note that this recall is not from Pfizer but from the repacker who SOMEHOW obtained tablets made by someone else. It only effects the 10mg size so you are safe if you take a different dosage. The following lots are involved in this recall: 20722V - 90-tablet bottles, 10 mg, Expiration 09-2004 04132V - 90-tablet bottles, 10 mg, Expiration 01-2004 16942V - 90-tablet bottles, 10 mg, Expiration 09-2004 …Click here for full text of FDA's story. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01224.html

2) Hormone replacement therapy: another downside.

More dementia in women taking hormone replacement. (There is a joke here somewhere but I'm not goin' there!) Sales of Premarin and Prempro were already down. While this sounds like a good thing for drug spend…think again… the use of bisphosphonates are up and continue to rise as women try to protect their bones. …Click here for full text of story. http://news.moneycentral.msn.com/ticker/article.asp?Feed=RTR&Date=20030527&ID=2585748&Symbol=US:WYE

3) …but don't just say NO!

The FDA is not encouraging women to stop their hormone replacement therapy either. They were quick to point out that prevention of cognitive dysfunction was NEVER an APPROVED use of the drug. This is one reason that "off-label" use of drugs is not encouraged and why so many plans do not pay for the off-label use…. it is just experimental. …Click here for full text of story. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01226.html

4) 650 ulcers can't be all wrong.

Kaiser Permanente normally does good research so I'll have to get a copy of the article to review. Not too suprising that the group that had testing cost more that the group that didn't. About 1/3 of the "peptic ulcer patients" had an active ulcer (by x-ray or scope) after being treated for 1 year prior to the study. Sounds like the drugs were working for 2 out of 3. I'm sure that more studies will have to be done. I applaud the attempt at using evidence to make health decisions. You think it might catch on? …Click here for full text of story. http://story.news.yahoo.com/news?tmpl=story&cid=97&ncid=97&e=3&u=/hsn/20030527/hl_hsn/testing_for_stomach_bacteria_doesn_t_help_with_peptic_ulcers

5) There they go again…Merck tries to shake Medco for the fourth time.

Why would anyone want a part of this "new" stock offering? Shareholders will get the stock "for free" so that Merck become a drug "pure-play". Many investors in Merck did not like the acquisition of Medco to begin with at a time when Merck was the number one drug manufacturer. Presently they are #3. Medco will remain yoked to Merck (for better or worse) through financial ties. It will be interesting to see how it looks in a year. …Click here for full text of story. http://biz.yahoo.com/djus/030529/1018000648_2.html

6). "HerbaL" preparation turns out to be Viagra lyin' in the weeds!
	" Viga" is the name…only 2 letters short of Viagra… recalled by BEST LIFE and the FDA. Pretty dangerous stuff if you are on nitrates (such as nitroglycerine). …Click here for full text of story. http://www.fda.gov/medwatch/SAFETY/2003/viga.htm

7) Ilo get a bum rap!

This article talks about off label promotion of Neurontin. I worked with Ilo Leppik in collaborative research more that 20 years ago. We published scientific papers on epilepsy together. I know him to be a research scientist of honor and integrity and an epileptogosist to which the toughest patient were referred. Physician may use drugs "off-label" once they are FDA approved. There are some strict rules about how a DRUG COMPANY can promote drugs…. it must be for FDA indications only. The drug companies may pay speakers who have used drugs off-label who may discuss their work. Truth is that many anti-epileptic drugs are useful in bipolar disorder and pain. The medical information side of the drug company (which is to be separate from sales and marketing) can provide information on "off-label" use upon request. I'm sure that all of this will come out in the anticipated litigation. While I'm not sure how well the drug company will fare, I believe that my buddy will be exonerated. Aside: You don't think that the "whistle blower" will donate his "reward" to science do you? …Click here for full text of story. http://www.nytimes.com/2003/05/30/business/30DRUG.html?th

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Have a GREAT 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 a supervision of you 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 pharmworks@pharmworks.com . All insightful comments from readers are thoughtfully considered (the rest are callously discarded). Copyright 2003 PHARMWORKS,LLC all rights reserved.