Off-Label Promotion Could Land Former Drug Executive In the Pokey

No doubt you have learned (or are learning) about off-label promotion of prescrition drugs. The FDA has become very aggressive in pursing charges against companies when they violate this prohibition. Typically, cases for off-label marketing are settled with the company paying a fine. In fact, in this case the company agreed to pay about $37 million in 2006 to settle charges related to its marketing, but they also went after the "head man" of the company. Although the executive was acquitted by the federal jury in San Francisco of a related charge of off-label marketing itself, known as “misbranding,” he was convicted of wire fraud.

Wire fraud carries a maximum sentence of 20 years in prison and a $250,000 fine. The executive is free on bond awaiting sentencing. The bottom line? If you work for a drug company be careful about what you say!!

To learn who the executive was, who he worked for, and what drug was being promoted read the whole story in the New York times:

http://www.nytimes.com/2009/09/30/business/30drug.html?emc=tnt&tntemail1=y

Whose Birthday Is It?- September 30, 2009

Over the years, it has become customary for me to announce birthdays that I become aware of. Life could be simple and I could just wish these folks "happry birthday." But that wouldn't be in the tradition of our Pharmacotherapy "Sherlock Holmes" theme. So, I offer these two co-birthday celebrators as our first challenge. See ifyou can solve the mystery.

Congress Investigates Sports Supplements

The Associated Press reports that an influential senator is looking into whether Congress should re-regulate dietary supplements because steroids and other banned substances are finding their way into over-the-counter bodybuilding products.


Sen. Arlen Specter, a Pennsylvania Democrat and Philadelphia Phillies fan, is convening a Senate Judiciary Committee hearing on the issue Tuesday.


He said his interest was piqued in part by the case of Phillies pitcher J.C. Romero, who was suspended for 50 games this season after testing positive for androstenedione, a substance that slugger Mark McGwire used in the 1990s that was later banned by baseball.

Here is a short new clips from Good Morning America:

Now, That's a Lot of Cocaine!!

The British navy seized its biggest haul of cocaine, worth £240 million ($380 millions), in raids in the waters off Colombia.The Portsmouth-based frigate HMS Iron Duke and US Coastguard jointly intercepted an old fishing vessel, MV Cristal, in a "high-speed pounce" on September 15, Britain's Ministry of Defense announced Monday. A day-long search found a five and a half tonne stash, being smuggled in an area known for trafficking. The boat was later sunk by gunfire.

Check out the video, especially the end part:

"Doering's Got a Touchdown"

For many years around these parts I was known as "Chris' Father" and not Professor Doering. Since he stopped playing football in the NFL some years ago, I have finally regained my identity. However, this weekend I will gladly yield the stage back to him, because it was at the UF vs. Kentucky game on September 11, 1993 that Chris has his breakout game. It occurred to me the other day that most of you were 7 or 8 years old at the time and may not have heard about "The Catch." Come with me back to that later afternoon on a crisp Fall weekend in Lexington for an admittedly self-indulgent moment in time:

The Vicodin Song

I like music of all types, ranging from oldies to rock to (some) hip-hop, etc. Last Spring I was asked to put together a presentation for the students on the main campus talking about how song lyrics often contain subtle or overt references to drugs of abuse. Someday, I'll share that presenation with you all. Recently, though, I came across the video below called "The Vicodin Song."

The refrain of the song goes something like this: "i've got vicodin, do you want to come over, i know it's a long drive from malibu, i got a pocket full of pills..." The artist, Terra Naomi has a nice voice, but the song is best described as "maudlin." Take a look:



Some of you may know music, especially drug-tinged music, much better than me, but I find these songs to be very depressing. Then again, struggling with chemical dependence is depressing in and of itself. Check out this video by The Verve called "The Drugs Don't Work." released in September of 1997. Some say its in reference to the signer's father who became tolerant to his chemo and pain regimen. Click here to decide for yourself.
http://www.youtube.com/watch?v=n4XCGeckA-E

Medical students crossing the line on the Internet

That's the headline on several news outlets, Believe it or not, a paper in this week's JAMA reports on the activity of medical students using social network sites. We may be in similar trouble with Mr. Beal. He is a fiesty old rascal, isn't he?

Check out the article at the following:

http://hosted.ap.org/dynamic/stories/U/US_MED_MED_STUDENT_HIJINKS?SITE=ORLAG&SECTION=HOME&TEMPLATE=DEFAULT

Sign, Sign, Everywhere a Sign....

How long do you think it will take the Administration to post signs saying "Don't Lock Bikes to the Trees." Kinda reminds me of the 70's song by the Five Man Electrical Band simply called "Signs." This song was written by Les Emmerson after driving to California along Route 66, where he had noticed the many billboards obscuring his view of the U.S.A.

The first verse and the chorus goes like this:

Verse I

"And the sign said long haired freaky people need not apply So I tucked my hair up under my hat and I went in to ask him why He said you look like a fine upstanding young man, I think you'll do. So I took off my hat, I said imagine that, huh, me working for you , whoa!

Chorus:

Sign Sign everywhere a sign Blocking out the scenery breaking my mind Do this, don't do that, can't you read the sign." You might recognize this song better from it re-make in the eighties by Tesla.

Here is a cute video set tot he music of "Signs.". Warning: This video deals with some adult themes."

http://www.youtube.com/watch?v=qLm3HMG8IhM

Did You Know that Oktoberfest Actually Starts In September?

Yes, that's right. The Oktoberfest 2009 will take place from September 19th, 12:00am (noon) to October 4th, 11:30pm. (The 19th is tomorrow if you didn't realize it!!) Although you might think the photo at the left is of three "authentic" Germans, actually it was taken at last year's Multicultural dinner.

For more information about the "real" oktoberfest, you may wish to visit:
http://www.oktoberfest.de/en/

Looks Like a Case for the "Ghostbusters"

Today's headlines in the New York Times:

Medical Editors Push for Crackdown on Ghostwriting Crackdown. Whew, I feel better now that the Ghostbusters are on the case. Stay tuned for more exciting adventures of "There's a Ghost Among Us in the Helath Center Library."

(I ain't afraid of no Ghosts!!)
http://www.nytimes.com/2009/09/18/business/18ghost.html?_r=1&emc=tnt&tntemail1=y

What's Up With This Guy and the Albuterol?

I Promise, Just One More About Albuterol. I couldn't resist posting this. I am not sure what it's all about, but it is kinda weird, don't you think?

Albuterol from Ty Tuin on Vimeo.

Speaking of Albuterol, How' Bout the Band Called Albuterol and the Inhalers?

Yes, it's true, there IS a band called Albuterol and the Inhalers. I am not entirely sure what their connection to albuterol really is. Maybe one of the band's members is named Al Buterol. Perhaps he has a European cousin called Sal Butamol.



Also, click here to go to the band's MySpace page.

http://www.myspace.com/albuterolandtheinhalers
]
By all means, click the icon below to watch them totally destroy the Beatles hit "I Saw Her Standing There"

..... And While You're at it, Give Me all Your Albuterol

Yes, there has been another major crime committed against the pharmaceutical world. A truckload of albuterol inhalers has been hijacked. Next thing you know, they'll be demanding all the Tylenol you've got in the store.

See the details of this dastardly deed at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm181749.htm

"Put Your Hands Up and Give Me all Your Insulin"

One of the most frightening things as a pharmacist must be staring down the barrel of a loaded revolver while the perp demands that you hand over the drugs. Some of you may have actually had this happen to you. The usual targets are the C-II prescriptions: OxyContin, Percocet, Vicodin, and others.

This is the first time that I've ever heard of people stealing insulin. Check it out at the following site:

http://www.youtube.com/watch?v=xdYAuKixVho

'Til Death Do We Part- Marriage Among the Elderly (But Hurry. We Don't Have Much Time)

Jacob, age 92, and Rebecca, age 89, living in Florida , are all excited about their decision to get married. They go for a stroll to discuss the wedding, and on the way they pass a drugstore. Jacob
suggests they go in.
Jacob addresses the man behind the counter: "Are you the owner?"
The pharmacist answers, "Yes."
Jacob: "We're about to get married. Do you sell heart medication?"
Pharmacist: "Of course we do."
Jacob: "How about medicine for circulation?"
Pharmacist: "All kinds ."
Jacob: "Medicine for rheumatism?"
Pharmacist: "Definitely."
Jacob: "How about suppositories?"
Pharmacist: "You bet!"
Jacob: "Medicine for memory problems, arthritis and Alzheimer's?"
Pharmacist: "Yes, a large variety. The works."
Jacob: "What about vitamins, sleeping pills, Geritol, antidotes for disease?"
Pharmacist: "Absolutely."
Jacob: "Everything for heartburn and indigestion?"
Pharmacist: "We sure do."
Jacob: "You sell wheelchairs and walkers and canes?"
Pharmacist: "All speeds and sizes."
Jacob: "Adult diapers?"
Pharmacist: "Sure."
Jacob: "We'd like to use this store as our Bridal Registry."

On the Lighter Side: Rx versus OTC?

A nice, calm and respectable lady went into the pharmacy, walked up to the Pharmacist, looked straight into his eyes, and said, "I would like to buy some Cyanide."
The pharmacist asked, "Why in the world do you need cyanide?"
The lady replied, "I need it to poison my husband."The pharmacist's eyes got big and he exclaimed, "Lord have mercy! I can'tgive you cyanide to kill your husband. That's against the law! I'll lose my license! They'll throw both of us in jail!All kinds of bad things will happen. Absolutely not! You CANNOT have any cyanide!"
The lady reached into her purse and pulled out a picture of her husband in bed with the pharmacist's wife.
The pharmacist looked at the picture and replied, "Well now, that's different. You didn't tell me you had a prescription."

Neurological and psychopathological sequelae associated with a lifetime intake of 40,000 ecstasy tablets.

Patient: Are you the pharmacist?

R.Ph.: Yes, what can I do for you?

Patient: I was just wondering if it would hurt me if I took 40,000 Ecstasy pills?

That's a lot of ecstasy for one person to be taking. Check out the paper at:

http://psy.psychiatryonline.org/cgi/content/full/47/1/86

Skin Whitener Ads Spark Outrage

Now I've seen everything!!

http://news.aol.com/health/article/skin-whitener-ads-in-india-pakistan/664878?ncid=bannadusaolp00000002

Some Good Info on A-Fib

I stumbled across a good link to a Continuing Education Program that really summarizes many of the points from this case: http://www.ashpmedia.org/symposia/afib/overview.html

Only a couple of points I want to make. First, the program is sponsored by Sanofi-Aventis. You should consider this since this drug company has a stake in this disease category. Hint: do you know what Multaq is?

Also, there is a "Supplement Issue" of the Journal of Managed Care Pharmacy about A-Fib:

http://www.ashpadvantage.com/website_images/pdf/jmcp_08012009.pdf It is important to rember that this is a supplement edition. Do you know why that is so important?

We Couldn't Have Made This Up, Even if We Wanted to

Every so often we get feedback from current or former students about specific incidences that happen in their practices that illustrate what we are trying to accomplish in class. Here's an unsolicited communication that makes me want to jump up and down with unbridled joy!! (Okay, that visual is a little over-the-top!). It's from 4PD student John Sheehan (before haircut) who sat right where you are sitting in PTX IV one year ago. Oh, he is also the guy in some of the videos on our ELS site.

Professors Munyer and Doering,

I wanted to write the two of you to let you know about something that happened to me today. I started my community practice rotation at the Walgreens in Jonesville, and sometime this afternoon a lady came up to the counter with a question. She was holding two different OTC
products for the treatment of a vaginal yeast infection and wanted to know the difference between the two and which I would recommend.

The interesting thing about this is that I was called on during the feminine issues self care last year and had to field a similar question in front of 130 people. That experience definitely made the patient encounter today a piece of cake. I just wanted to let both of you know that my experiences last year have definitely improved my patient interaction skills. Please feel free to share this anecdote with the current class. Hopefully it will help them realize that the scenarios we go through in class are very much like the situations that come up in practice and that being called on isn't a form of torture, but a very valuable learning experience.

Much thanks to both of you.

No evidence for the routine use of aspirin in people with asymptomatic vascular events: results from the AAA study

I thought I had finally gotten it straight: everybody in the world should be taking a low dose aspirin a day to protect from heart disease. That's pretty easy. right? No exceptions, no complicated algorithms, no need to think.

Well, as a noted sportscaster often says "Not so fast my friend." A new study reported just a few days ago looks to re-write the rules. The headlines in Yahoo News is a little more bold:

'Daily aspirin may do more harm than good: study." http://news.yahoo.com/s/afp/20090831/lf_afp/healthresearchheartbritain

I'll bet you that people all over this country are tossing their aspirin bottle in the garbage. There's an old expression that goes somethin like this: 'The Devil's in the Details." You may wish to look for yourself how this study was designed, how it was conducted, how the data were analyzed, and what it all means. I promise you it will give you a glimpse of what lies ahead in the EBP course: Just when you think you have all the answers, they go and change the questions. Here's the press release:

http://www.escardio.org/about/press/press-releases/esc09-barcelona/Pages/HotLine1-Fowkes-AAA-study.aspx

Here's the puny local coverage I get from the local radio station, WRUF:

A new study done has found that taking an aspirin a day may not always be the best option. British scientists have found healthy people who take aspirin regularly are doubleing their risk for harmful stomach bleeding. The findings also show that aspirin does not reduce the risk of heart attack in healthy people. University of Florida pharmacist Paul Doering says we must be careful to not mistake the findings in this study. He says if you are at high risk for a heart attack or if you have previously had a heart attack, you should keep taking an aspirin each day.
Doering says the best thing is to ask your doctor whether or not an aspirin a day is right for you.