Thursday, December 27, 2007

Once Again, The Drugmonkey Gets Results. Merck and Schering's Head Partially Emerges From Their Ass.

It was a little over a month ago that I wrote the two titans of Big Pharma a public letter in this very blog:

Dear Merck/Schering.

Your bullshit has been called. Please remove your head from your ass and do the right thing.

Sincerely,

Drugmonkey, Master of Pharmacy.


Regular readers of my little blog garden already know that what had my boxers in such a bunch was Merck and Schering's decision to alter the definition of the Enhance study's "primary endpoint." For those of you playing along at home, that means they started this study with one definition of what they were going to measure, then when the data actually came in decided that no, they changed their mind and they were going to look for something else. This kind of thing is not done in science, and the Drugmonkey was not going to let them get away with it.

Behold, the caving of Big Pharma:

The lead researcher of a long-delayed drug study says he regrets not standing up to Merck & Co. and Schering-Plough Corp. when they first told him last month that they planned to alter the statistical analysis of their jointly sponsored trial.

Under mounting criticism, the companies last week reversed the earlier decision to change the primary measure to evaluate the drug. The study, called Enhance, tested 720 people to determine whether a combination of Schering-Plough's Zetia and Merck's now off-patent cholesterol fighter Zocor works better than Zocor alone.

John P. Kastelein, a cardiologist at Academic Medical Center, Amsterdam, and principal investigator of the study, said he breathed a "sigh of relief" when the companies told him last week they were reversing course.

"It's never, ever right to change the primary endpoint of a study," especially after all the data are in, he says. "It is statistically not good and it gives the wrong impression to the outside world." He says he initially went along with the plan but now regrets not firmly resisting it from the outset.


You are now my bitch John P. Kastelein. You now say you wish you had opposed this cockamanie plan from the moment you heard of it. I did. I own you.

Big Pharma is so afraid of me they couldn't even personally tell me of their decision, leaving it up to an alert reader to inform me of my triumph. That was kinda rude of them. Not to mention they are still hiding the extent to which they know Zetia can harm your liver. We know that the number of people who had to stop taking Zetia in the Enhance study due to elevated liver enzymes was somewhere between 1 and everyone. Merck and Schering will not be more specific than this. We also know Merck and Schering have done other studies that raise questions about Zetia's risks to the liver, but never bothered to publish them. It's time for another letter:

Dear Merck/Schering,

While your head appears to have moved, possibly to the part of your large intestine just above the rectum, it still has a ways to go to get completely out of your ass.

Consider me your laxative.

Sincerely,

Drugmonkey, Master of Pharmacy

Tuesday, December 25, 2007

Merck And Schering Don't Want You To Know They Have Studies Showing Zetia May Harm Your Liver. Whoops. Maybe I Wasn't Supposed To Say That.

Regular readers of this very blog already are well aware of how these two companies, joint marketers of the wildly popular cholesterol med, appear appeared to be sitting on data gathered to show how well the med works until they can could manipulate it to say what they want.

Readers of the New York Times also know this.

Well today, lucky readers, you will get another scoop concerning Merck, Schering, and Zetia skulduggery. And you will get it a mere 4 days after the readers of The New York Times.

New evidence shows that the drug makers Merck and Schering-Plough have conducted several studies of their popular cholesterol medicine Zetia that raise questions about its risks to the liver, but the companies have never published those results.
The unpublished studies, conducted from 2000 to 2003 according to the F.D.A. documents, were not listed on the industry Web sites where companies are supposed to register the results of all drug trials that were ongoing after October 2002. The New York Times discovered references to the studies in briefing papers on the F.D.A. Web site.


Huh. Wonder why that is. Because you know, the studies that show Zetia lowers cholesterol don't have any trouble showing up in these databases. Or as the first thing you see when you punch up the Zetia information for health care professionals web page. Yet the studies that show Zetia may put your liver at risk seem to get lost. What are the odds really?

A Schering executive, when asked by a reporter about the unpublished studies, confirmed their existence. But the executive, Dr. Robert J. Spiegel, said the companies had not considered the studies scientifically important enough to publish their findings. Some may eventually be published, he said.


I can't believe I just fucking read that. Here's a wild, crazy idea. Publish the studies, the way you are supposed to publish every single study done since October 2002, and let scientists not on Big Pharma's payroll decide what is scientifically important. That's why the clinical trial database was set up in the first place you numbnuts.

There is at least one big-ass scientifically important study involving Zetia going on at the moment though. It's called Enhance. Big Pharma loves to give its studies cute sounding names. Enhance is the effectiveness study I mentioned at the top of this post whose data Merck and Schering are sitting on while they change seriously thought about changing the definition of the study's "primary endpoint" science speak for what they were looking for. The enhance study was completed in April, 2006, but we still don't know the results. Except for this little tidbit:

Schering spokesman Lee Davies, disclosed this week that some patients in the Enhance trial had been dropped from it after tests showed that they had elevated liver enzymes — a potential sign of organ damage. But Mr. Davies said he could not disclose how many.


Why not? If the number were zero I'll bet you he'd be disclosing it. I think the story here is that Schering spokesman Lee Davies would not deny that 100% of patients in the Enhance trial had to drop out because of elevated liver enzymes. If Schering spokesman Lee Davies would like to issue a denial that 100% of patients in the Enhance trial had to drop out due to liver damage, I will happily print it here. Until he does though, all we know is that the number of people who had to drop out of the Enhance trial due to elevated liver enzymes is somewhere between one patient and all the patients. I'm sure Merck and Schering have a good reason for keeping us in the dark about this though.

There are also no studies that show Zetia actually lowers the number of heart attacks or deaths in people who take it. Unless Merck and Schering are sitting on that data as well. Don't bet on it.

Monday, December 24, 2007

Now That I Think About It, There's Really No Need For Me To Be Scared Of Vampires Anymore.

I mean, the AIDS probably killed off most of the vampires back in the 80's I imagine. And quite honestly, even if there are any vampires left, between HIV, Hep C, Ebola and a host of other blood-borne diseases, they are probably more afraid of us these days than we are of them.

In your face vampires.

I Can Think Of No Better Way Of Saying "Merry Christmas" Than By Rerunning An Old Blog Post.

That sounds like a snarky line, but it also happens to be the literal truth. I'm not in a state of mind conducive to writing new stuff at the moment. Don't ask me why. I'm just not. I originally posted this last Christmas Eve under the title Well Tonight Thank God It's Them, Instead Of You. Enjoy it again. Or not.

You got the best line in the whole song Bono. Of course back then you deserved it. You're sorely missed you Irish bastard, all the more so because you're still around.

We're not so different Mr. Bono, you and I. We both saw how the world shits on people who don't deserve it and were beside ourselves as to why. I decided that I wouldn't do anyone any good if I couldn't put food in my own stomach though, and I'm sure you felt the same way about your band; doesn't do any good to bug someone if they're not listening I suppose. But by the time our personal dollars had been stabilized we both found ourselves swept away by forces we no longer controlled. I took a job for corpo-pharmacy and your concerts were promoted by Clear Channel Communications. You sell your red iPods and I write a check to Oxfam and on the day we die the world will be shitting on people who don't deserve it. I miss you Bono. I miss me too.

Merry Christmas fuckers. Tonight thank God it's them instead of you.


Friday, December 21, 2007

I May Be Single Handedly Responsible For Every Chain Pharmacy In This Country Being Woefully Understaffed

Why? Because Corpo-pharmacy bigwigs know that the very second I am not drowning in prescriptions, things like this start happening to their displays.



The horses have been going at it for two days now. If anyone bothers to notice, and figure out the source, It'll probably make my lobbying for more tech help a little harder.

Does make the 12 hour day go a bit quicker though.

Wednesday, December 19, 2007

George Bush Issues A Challenge To The Drugmonkey, To Which I Say Bring It On

Unfortunately it wasn't in the boxing ring. George's challenge came in a speech given in front of a Rotary club. Who knew the most powerful person on the planet spends his time talking to Rotary Clubs in BFE Virginia?

I'm going to tell you something -- we have fabulous health care in America, just so you know. I think it's very important -- before people start griping about the health care system here ....just to compare it with other systems around the world.


Yeah...you know what?....I'm gonna tell you something. You don't say things like that around the Drugmonkey. Because the Drugmonkey will call your bullshit and bitch slap you with the facts so hard you may never get up again. You wanna compare US health care with other systems around the world? Fine. It's go time:

-The United States has fewer doctors, fewer nurses, and fewer hospital beds per capita than the average country in the Organization for Economic Co-operation and Development. Maybe by "fabulous health care" George Bush meant "fewer people providing health care"

-Rates of chronic disease are significantly higher among middle-aged people in the United States (before they are eligible for Medicare) than in that den of socialized medicine, the United Kingdom. The rate of diabetes is twice as high. Heart disease, 57% higher. Lung disease, 29% higher. Cancer.......73% higher. Maybe by "fabulous health care" George Bush meant "more people that need health care"

-37 countries have a higher life expectancy than the United States. Including Cuba, Chile, The United Arab Emirates, Costa Rica, Cyprus, and Malta. You wanted me to compare our health care with other systems around the world president wanker-boy. Be careful what you ask for.

There is one area of health care where the American system clearly leads the world. Spending! Here's a nice little factoid for those of you who like to think of yourselves as guardians of our taxpayer dollars. In the US, about 45% of the total amount spent on health care is paid for with government dollars. Our Canadian friends use government funds to foot the bill for about 70% of all health care in that country. And use fewer government dollars per person to do it.

Are you getting this? Canada runs an entire health care system, for everyone, for less per person than we spend on just Medicare and Medicaid. So does France. And Japan. You'll find Japan at the top of the list of life expectancy by country. The UK that so kicks our ass in chronic disease prevention does it while spending about 60% less per person than we do.

Tell me again why I'm supposed to be afraid of socialized medicine?

I could go on all night my friends. There are few issues where those on the right are so clearly and demonstrably wrong. Yet you let them pull the wool over your eyes with nothing but a little jingoistic flag waving. Americans love to hear we are the best in the world, but in health care we most assuredly aren't. Stop saying we are, and start working to make it so.

Monday, December 17, 2007

If I Were Rudolph The Reindeer, I Would Have Told Santa To Go Fuck Himself.

I would have been like. "You bastards have given me shit my whole life and NOW you want me to bail you out?? You can kiss my reindeer ass"

Then I would have been like "You know, while I was excluded and ostracized all those years, I worked on a few reindeer games of my own, since you would never let me play any of yours" There would be a crazy look in my eye.

Then I would take off and fly around in circles while Dancer and Prancer and the rest of those asswipes sat grounded with all the undeliverable toys on the shipping dock. Every once in awhile I would swoop down and kick them in the head or maybe bite them in the back while yelling "WHAT CHA THINK OF MY NOSE NOW MUTHA FUCKER?? TELL ME WHAT YOU THINK OF MY NOSE!!!!!"

I guess that wouldn't be a good way to mark Jesus' birthday though. I mean, hell, Jesus would never punish you years after the fact for being a bad person.

I don't think I can take listening to those songs at work for another week.

Sunday, December 16, 2007

A Special Message To All My Friends In Iowa.

And really, I consider everyone in the Hawkeye state to be my friend. Sit down Iowans, have some scotch. I'll have you know I don't share my scotch with just anyone, only my friends.

I take back all those mean things I said about you four years ago. It was just, well, after doing a lot of work for no pay for the one presidential candidate who could have changed the direction of this country, I was a little testy when you were too stupid.....er.....I mean...when you saw things differently. I made a bad choice when I called you a bunch of hillbilly inbred simpletons whose biggest worry was whether Jesus would ever see you naked, just like you made a bad choice when you handed the Democratic presidential nomination to John Kerry. We've both grown in the last four years, and I bet neither one of us will ever make a mistake like that ever again. There's a way you can undo your mistake though:




I bet you realize by now my Iowa friends, that when you have the privilege of making your selection for party nominee so early in the process, far removed from the actual issues we might be facing on Inauguration Day 2009, all you can really go on is leadership and judgment skills. Leadership and judgment skills like recognizing what the Iraq war was from the outset, and not being afraid to say so. Like Barack Obama did, 5 months before the war started:

That’s what I’m opposed to. A dumb war. A rash war. A war based not on reason but on passion, not on principle but on politics.

George Bush on the other hand, led Hillary Clinton off a cliff into a headfirst dive that landed nose deep in the stinking cesspool of Iraq. These days Hillary likes to say it's George's war, but she voted to authorize it and has never apologized for doing so. Don't take my word for it though, take hers. This is what she said as she took George's hand and made that cliff jump:

President Bush's speech in Cincinnati and the changes in policy that have come forth since the Administration began broaching this issue some weeks ago have made my vote easier. Even though the resolution before the Senate is not as strong as I would like in requiring the diplomatic route first and placing highest priority on a simple, clear requirement for unlimited inspections, I will take the President at his word that he will try hard to pass a UN resolution and will seek to avoid war, if at all possible.

That worked out really well, taking the president at his word. Because it was always so obvious how trustworthy George Bush was.

She also believed her husband when he said he never had sexual relations with that woman, which means she fell for the lies of two consecutive presidents. I'm afraid this means if she is elected president she will then believe her own lies, which I'm pretty sure would mean we're aquascrewed.

You can't vote for Edwards because he talks funny. I'm serious about this. I'm sick of having a president who talks funny.

So my dear Iowa friends, the choice is yours. Wait..... I forgot how you always force every serious presidential candidate to promise to support ethanol as a fuel additive. Something about the corn. You people are crazy about the corn, and ethanol has something to do with corn. So, yeah, I totally support whatever the deal is with ethanol, and I'm pretty sure Obama is in favor of you and the corn as well.

I know you'll do the right thing January 3rd.

Wednesday, December 12, 2007

Highlights From Today's Pill Counting Action.

The day started with me busting my thumb in the Gate Opening Olympics. I always pretend that I'm in some sort of competition when I'm turning the crank that opens the pharmacy gate to start the day, like the honor of my country is at stake and I am going for the gold. Sometimes when my keystone tech shows up early I issue an actual gate-opening challenge and I always win. It's one of the few joys I have at work. Today my hand slipped and I think I sprained my thumb. Glory does not come to those of faint mind or body.

The day's first customer witnessed my injury and thought it funny. The second asked me where the breakfast cereal was. This was as I overheard a third customer asking the stock clerk what would be the best product to remove ear wax. I looked around for the looking glass I surely slipped through.

Later in the day the cashier asked a customer picking up a prescription for clarification on how to pronounce the customers last name.

"Just like the bowling pin company" said the customer. Of course.

The same cashier speaks a few words of Russian, and later decided to surprise an elderly Russian customer by speaking a few words of her native language. The customer was delighted.

"Do you speak English too?" The customer asked in English.

A woman asked me what I thought of using super glue to repair her dentures. The store's assistant manager interrupted the conversation to ask if either of us had seen the skateboarding dog on YouTube.

A man asked me if we sold "Alloy Vortex" I eventually figured out he wanted some aloe vera. I also figured out he tried to alter the number of refills on his Soma prescription. I don't think these two facts are unrelated to each other.

I think exactly one customer requesting a refill had their prescription number and my thumb still hurts. You do not want to find yourself between me and the scotch bottle tonight.

Tuesday, December 11, 2007

From The "It's Their Real Name" File.

An Australian Catholic school is at the centre of an unholy row over claims it refused entry to a five-year-old boy with the surname Hell.

Alex Hell said St Peter the Apostle School, Melbourne, had welcomed his son Max when enrolled under his mother's maiden name, Wembridge.

But they baulked when the family had a change of heart over the surname.


Mr Hell said he initially decided to enroll Max at the school under his wife's maiden name, to avoid the ridicule he himself had suffered as a schoolboy.


OK, you know what there Hell, I might feel a little sympathy for you IF YOU HADN'T HAVE NAMED YOUR KID MAX.

MAX HELL.

You can't really blame the Catholic school. I'm pretty sure the book of Revelation warns of the day of the coming of Max Hell.

I Bet I Could Defeat George Bush In A Boxing Match

The key would be my arms. I have freaky long arms. That's why I usually wear short-sleeved shirts to work. Finding a long sleeve shirt that doesn't end a couple inches above my wrist can be a pain in the ass.

So what I would have to do is use my jab to keep Bush on the outside, because you know damn well if he got in close he would fight dirty. Elbows, kidney punches, ear biting, he would do it all. I would definitely have to establish my jab early. And watch out for any attempted waterboarding or extraordinary rendition attempts between rounds.

Plus George Bush is old, and he really doesn't look like he's aged well these last couple years. Yeah, I'm pretty sure in a fair fight he wouldn't stand a chance.

Of course to this point in his life George Bush has never been in a fair fight. I may be screwed.

Monday, December 10, 2007

Once Again, My Employer's Drug Utilization Review Software Saves My Ass.

And of course what I mean by "saves my ass" is "wastes my fucking time"....and yours.

Someone deep in the bowels of my employer's IT department decided it would be a good idea not long ago to add a new DUR warning to our system. DUR warnings stop the prescription filling process in its tracks. They must be overridden by me, and if they actually pointed out things that a pharmacist genuinely should be concerned about, they would be a good thing. The latest batch of DUR updates released into our system though, included one for the anti-acne med Accutane.

"Isotretinoin should be used with caution in women of childbearing age" says the warning that I must override every single time a prescription for Accutane or one of its generics is filled. Thanks. Fucking thank you for that. How about a warning next that sleeping pills may make you drowsy?

Real life sometimes steals your best material. There actually is a drowsiness warning label that prints out with every Ambien prescription filled at my store.

For those of you not in the profession, let me recap what happens before a female of penis-receiving age gets any
Isotretinoin into her grubby little hands.

-She needs to be on two different forms of birth control. Not all types of birth control cut it. No female condoms, No progesterone-only birth control pills.

-She needs to be on the two different forms of contraception for 1 month before a prescription is issued.

-Her doctor must document this and enter the information into the database of a "risk management" program called iPledge.

- iPledge then issues an authorization number that allows no more than a 30-days supply of
Isotretinoin to be dispensed.

- She brings the prescription to me. I have to call the iPledge mothership to get her authorization number.

- Authorization number has to be recorded on the prescription as well as in our computer.

-She needs to have a negative pregnancy test every month while taking
isotretinoin, and this information must be entered into the iPledge database, a new prescription must be issued, and a new authorization number obtained. Every month.

-Men have to get an authorization number as well. Just in case they're hiding some ovaries.

AFTER ALL THIS. Some numbnut at the company that employs me has now decided it would be a good idea to stop the prescription filling process seconds before it is complete to tell me "
Isotretinoin should be used with caution in women of child bearing age"

I forgot to mention I counted at least five different places on a box of
Isotretinoin where there is a picture of a woman with a big 'ol belly surrounded by a red circle with a slash through it above the words "CAUSES BIRTH DEFECTS -DO NOT USE IF PREGNANT"

The reasons your prescription takes so goddamn long to fill just keep on a 'comin. Release the scotch.

Tuesday, December 04, 2007

Upon Further Reflection, I Wonder If My Thoughts Didn't Somehow Kill Evel Knievel.

I mean, seriously, the first time I think about that motorcycle in years and he dies the next day. I'm sensing there may be some big-time bad karma involved with that motorcycle that my Mom was hip to.

I'm going to slowly back away from the topic of the Evel Knievel motorcycle and never mention it again.

Saturday, December 01, 2007

Tonight, One Of My Life's Great Mysteries Is Solved, After Evel Knievel Leaves This World By Kicking Me In The Nuts One Last Time.

So my keystone tech finally asked me why I was so warped. I told her I think it has a lot to do with the Evel Knievel motorcycle. I don't even know why I asked for it that first year. I'm pretty sure I never actually saw Evel do any of his televised jumps as a young Drugmonkey. It was probably the fourth or fifth thing on my Christmas list that year, but the only one I didn't get. I thought that was a little weird, and made sure to put the Evel Knievel stunt motorcycle at the top of my greed list the next year. Again, every single thing on my list, and then some, appeared under the tree come Christmas, but no Evel Knievel motorcycle. I thought maybe Santa was fucking with me.

The third year Evel was my top priority. I started lobbying weeks in advance. One time I shoveled the driveway without being asked. Dad yelled at me because I did it in my tennis shoes. Dad always had a thing about proper winter footwear. For the last time in my life, I made an effort to be good and kind and caring. The third year was gonna be make or break for Evel, and I pulled out all the stops.

You know what happened. I got a Bionic Man rocket ship that turned into an operating table. Whose idea was it to even design such a thing? I mean, would you want the space shuttle to turn into a giant surgical suite for some reason? My spirit was broken, but I continued to ask for the Evel Knievel motorcycle, its place lower and lower each year until it was replaced with a request for The Beatles White Album. I didn't get that either.

A couple years ago I finally asked my Mom why I never got the Evel Knievel motorcycle. "Oh, I don't remember" was the reply. The mystery of Evel Knievel would never be solved. A part of me would never be at peace.

My keystone tech got a good chuckle out of this, but my other tech had not a clue what I was talking about. Exactly like when I try to tell the other tech there is a difference between Effexor and Effexor XR. As I tried to explain the concept of the Evel Knievel stunt motorcycle set to the other tech, all those old feelings came back to me. It was like I was lobbying my Mom all over again, telling her how incredibly cool this toy was, and how cool I would be if only I could have it.

Then I realized. I'm an adult now, with my own money and control over my own purchasing decisions. Betcha I could totally find an Evel Knievel motorcycle on eBay. I decided as soon as this long work weekend was over, I was gonna set aside some time to find me an Evel Knievel motorcycle.

Of course that's when the bastard decided to die. The price of an Evel Knievel motorcycle has now I'm sure gone through the roof. I poured myself a giant dry martini, entered that magical buzz state where only gin can take you, pondered the situation, and after 30 years, it hit me.

That tone of voice. That my mom had when she said she couldn't remember. It was the exact same tone she uses when she doesn't want to talk about something. Dad had some sort of problem with Evel Knievel. I can't believe it took me this long to realize. I bet Dad thought Evel Knievel was gay. Jesus it all makes sense now.

I may sleep well tonight for the first time in years.