Avandia – Oh why are people so stupid.

**WARNING! Avandia and other prescriptions are hazardous to your health, and only should be prescribed and dispensed under the supervision of people who went to a collective of 15+ years of college and who KNOWS what the hell they are doing. This is because Rx drugs are DANGEROUS and require KNOWLEDGE to use effectively****
Duh right? Obviously not.
So Avandia is being tied to causing MI’s and related deaths in their patients. Lets look at some facts shall we. I bet the media isnt picking up on these:

• Look who funded this “Study” (from http://content.nejm.org/cgi/content/full/NEJMoa072761) Dr. Nissen reports receiving research support to perform clinical trials through the Cleveland Clinic Cardiovascular Coordinating Center from Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly. Dr. Nissen consults for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction. No other potential conflict of interest relevant to this article was reported.
  Yeah, does anyone else see something wrong with believing a study that was funded by the COMPETITORS of GSK? Im sure Dr. Nissen doesnt get ANYTHING from these companies. No sir. He probably doesnt get to use their houses in the Bahamas on their corporate jets and eat with the offical Pfizer credit card. Charity my ass.
  • Amazing how they didnt include trials that showed no deaths: Six of the 48 trials did not report any myocardial infarctions or deaths from cardiovascular causes and therefore were not included in the analysis because the effect measure could not be calculated. You think maybe that skewed the data a bit? Lets not include the studies that showed no risk, just the ones that did. Way to go douches.
    • The population this is being tested against is already at risk for having a heart attack. Its very well knows that Diabetics are at risk for stroke, Heart attack, Renal Failure, blah blah blah. Water is wet, the sun rises in the morning. Why is this such a big issue?
      • These risks are included in the package insert of Avandia, and are KNOWN risks, and have been known since the drug came out.
        • http://content.nejm.org/cgi/content-nw/full/NEJMoa072761v1/T3 Nice chart of all of the results. Notice the differences between placebo and Avandia? See how they are almost identical? So if you have say a p value of 0.05, and your study has 200 people in it, that 5% error margin is a lot of people. See where this is going?
          • The Lawsuits are already gearing up. AMERICA! WAKE UP! THIS IS WHY YOUR MEDICATION COSTS SO MUCH! SO DRUG COMPANIES CAN SURIVIVE BULLSHIT LAWSUITS BASED UPON ‘STUDIES’ BY BULLSHIT DOCTORS WHO SPEND MORE TIME GETTING KICKBACKSINCENTIVES BY THE DRUG COMPANIES AND STROKING THEIR OWN EGOS THAN ACTUALLY PRACTICING MEDICINE.
            Yes, Dr. Nissen, I’m talking about you. You and your flawed ‘study’ is causing me, my colleagues, and the doctors (who actually work and see patients) hours upon hours of time explaining to people why your study is no cause for alarm and they should NOT stop their Avandia without talking with someone with a clue (their doctor). You should be ashamed for causing so much useless and pointless panic over something that is (in the scope of things) retarded and unwarranted. I hope someone tears your ‘study’ a new asshole and points out the glaring flaws. I know you probably dont work for a living actually helping people, so i’ll give you a little pointer: Prescription drugs are dangerous, henceforth why doctors can only write them, and I can only dispense them. I know this is a foreign concept to you, but think about it next time you’re on that jet getting lapdances from the Lilly reps.
            In short, Americans want to listen to the media, who obviously know a lot more about medicine than their Pharmacist, their Doctor, or Nurse. I say if they dont want to take Avandia, thats fine, they can die an early death. Thin the herd a bit. Sometimes we need to take the warning stickers off of things and let nature run its course.
            Sorry this isnt more rantilicious. I’m gearing up for the NPI cutover clusterfuck that I know is going to drive me to an early grave tomorrow.

Comments #

Comment by Erie on 2007-05-23 00:11:16 -0700 #

Thank you! I needed this rant after fluries of phone calls today…

Comment by stuart on 2007-05-23 06:53:40 -0700 #

Since Dr. Nissen “reports receiving research support to perform clinical trials”, that means that GSK’s competition supports all his work, which means he has a job. If someone doesn’t pay for the cost of your research work it isn’t going to happen. Indirect though it may be, he owes them all big time.

Comment by Met on 2007-05-23 08:39:31 -0700 #

I heard my pharmacists talking about this yesterday morning, but didn’t hear much. Now that I’ve heard the explanation, I feel disgusted, at both the media for fearmongering this crap for ratings (I’m still pissed at ABC for their pharmacy tech “expose”), and the idiots who gobble this up without questioning the study. I thought the point of research science was to question everything and demand more experiments. But I forgot, that’s only if it’s real science that no one ever hears about.

Comment by nnp on 2007-05-23 10:38:51 -0700 #

this is hilarious….
we need to go drinking sometime………..

Comment by Erin S. on 2007-05-23 19:12:38 -0700 #

And all the pharmacists say AMEN!!! Thanks for a good laugh. After a day of Avandia and NPI hell, this was a great pick me up!

Comment by FDPharmD on 2007-05-24 09:42:27 -0700 #

“http://content.nejm.org/cgi/content/full/NEJMoa072761) Dr. Nissen reports receiving research support to perform clinical trials through the Cleveland Clinic Cardiovascular Coordinating Center from Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly. Dr. Nissen consults for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction. No other potential conflict of interest relevant to this article was reported.”
riiiiiiiight, and I do work for free too!
They also support his research through the clinic, so they donate money to the clinic so it stays open…oh ya, and the clinic writes his paycheck…so how is he not getting money from this (as well as tons of perks).
Also, a great colleague of mine who is a fantastic community pharmacy was being approaced by a big company to consult for them…guess what he had a 1st class plane ticket, limo and luxury suite…he did not donate his money to charity!

Comment by The Angry Intern on 2007-05-24 20:16:45 -0700 #

It was funny that I just got finished working a 9 to 5 day today where not one, but TWO people thought I was trying to kill them. Why? Because when they came to pick up there 5 or so meds, one of them happened to be AVANDIA. The one lady asked me, ‘is my Avandia filled?’ To which i replied that it was and it was in the bag with all of her other meds. To my surprise she looked at me as though I just stabbed her in the chest and literally screamed at me to take it out of the bag immediately, because obviously I just magically filled her Avandia and threw it in there with the rest of her meds because I take pleasure in filling meds that patients don’t call in to be refilled, just to see how they react. NOT. You called it in you silly old bag, so yeah, we filled it. And no just because it was in your bag doesn’t mean it cross-contaminated the rest of your meds and I’m not recounting all those pills.
On a lighter note the other patient just smiled and said, ‘I won’t be getting my Avandia refilled because I don’t want to die.’ I swear I couldn’t make this stuff up. And to hear about who “funded” this little study just made me giggle. It is just sad that the general public is so gullible.
Are there any postings on how amazing that the drive-thru can be at a pharmacy? Because if there are not, there needs to be. Because after working the register at the drive thru for a few years before becoming tech certified and then accepted to Pharm School, I’ve got a lot to say about that little 3 foot by 3 foot window.

Comment by Count By Five on 2007-05-25 11:58:36 -0700 #

In regards to the six excluded studies, I believe you may be off a bit in your interpretation of the exclusion reasoning. If I read the study correctly, and thats a big ‘if’, those six studies were excluded because they did not measure CVA or MI as a statistic. The authors go onto later say in the Methods section that they did include some studies where CVA and MI was measured but no one in these studies had a heart attack.

Comment by Respectful Insolence on 2007-05-25 12:05:22 -0700 #

Well, well, well, what have we here about the Avandia study?

I’ve been meaning to go through the recent meta-analysis of Avandia published by the New England Journal of Medicine that purported to show major increase in the risk for cardiac events (myocardial infarctions and cardiac death) in patients who use…

Comment by Bradley J. Fikes on 2007-05-25 14:52:28 -0700 #

I’m a health care reporter who found your site through Orac. Thank you for writing about this.

Comment by the angry pharm tech on 2007-05-25 17:48:31 -0700 #

It does suck so bad…so many drugs…so many warnings, and not enough follow-up
who KNEW imitrex could blow up your heart???
ugh
on the positive side….allie will be out for OTC sales soon…and THAT will be interesting.
These big ole missouri girls will throw a handful of those in, and wash em down with a big mac and a coke…
I believe the fact sheet description is
“Explosive flatulence with oily discharge”
YAY!! Life just got interesting!!
came in searching for your email addy…got some hillarious things to pass on….
e

Comment by Pharma Rep on 2007-05-26 07:03:04 -0700 #

It is good to see that someone understands the possible agenda behind Dr. Niessen’s meta-analyis. I am a GSK rep and have been out the past week discussing this information with the doctors and nurses. Some know good science, some don’t, and some just don’t want to know. It was refreshing to read something from a pharmacist perspective on this “study”. Also Dr. Niessen maybe has caused such a panic that the results from the RECORD trial could be in jeopardy because some of the clinical trial participants are leaving the study. Thanks for your sensibility!

Comment by drugmanrx on 2007-05-29 21:14:51 -0700 #

This study should be a no brainer as Avandia has been shown to elevate blood lipids across the board. The study should have included data on patient’s lipid measurements to properly asses the risk of of cardiac related deaths and whether or not those patients who were taking Avandia were also on appropriate lipid lowering agents if they had elevated lipids. There are so many factors that go into calculating a person’s risk for having a cardiac death (smoking, lack of exercise, high lipids) it would be difficult to assess whether or not taking Avandia would increase those risks alone. I would be willing to bet those people who had cardiac deaths had additional risks factors (including uncontrolled blood lipids) that put them there. They might have well as done a study looking at taking Avandia versus not taking medicine at all to see if a person lives longer versus dieing early from diabetes complications. That study would also be a no brainer.

Comment by Mike on 2007-05-30 11:02:25 -0700 #

Nice post. I love the vitriol.
Avandia I rpedict will be vindicated, unlike Vioxx. Did they breakdown the CHF patients who inappropriately got it, or didnt have their dose reduced? I haven’t looked at it all yet.
STAY ANGRY!!!

Comment by Justin on 2007-06-09 16:26:17 -0700 #

Open the pharmacy gates, turn on the lights, and the phone is already ringing. First call of the day is about Avandia. I’m sorry I do not watch the news in the morning, the night before airing of The Colbert Report is much more important. So I am stuck answering questions about a study that I have not only never heard of, but has not even been published at the time of the news release. Thanks again Grandma for calling me and starting my day off on a good note. Next time call your Grandson at home if you want to talk about your medication. Do not call him up at work and challenge his professional opinion with someone on the Today Show. Matt Lauer, PHARMD ??

Comment by Ruth on 2007-06-14 01:11:45 -0700 #

THANK YOU for this post. Looking forward to the one I hope you will be doing on Alli, with its debut coming up, fatty stools and all!

Comment by DT on 2007-07-02 22:48:41 -0700 #

I am surprised that you do not understand the statistical concept of a p value.
To quote your entry, “if you have say a p value of 0.05, and your study has 200 people in it, that 5% error margin is a lot of people.”
A p-value is not an error margin. It is a level of significance. A p-value has nothing to do with the people in the study and does not refer to a percentage of individuals involved.
My best explanation of what a p-value is is the following: If this study were done a hundred times the same way, five percent of the time the null hypothesis would be proven true when it is in fact false (basically a bad result).
However, we cannot say that this particular study is ninety five percent likely to be true. It is either a correct conlclusion or a false one (It is not accurate to say that this study is 95% likely to be true.)
We can however say that if this study were done a hundred times, about 5% of the conclusions of those studies would be incorrect (and it would be impossible to tell which ones were the wrong ones).
-ProfDT

Comment by Ellie Oxnard on 2007-07-24 08:11:00 -0700 #

Thanks for your post. People are stupid. That’s why hairdryers now come the warning “do not use while sleeping”. We have completely surrendered our cognative thinking to the media and are afraid to make decisions on our own. I work retail and spend all day answering stupid questions. Mostly “why’s”. Why, why why. It’s like dealing with four year olds all day, but worse becasue adults take everything as a personal affront to them. “Why don’t you have this in Red???” I Don’t know why! The CEO of the company with obviously more education than me didn’t call me up to discuss it! -EO

Comment by Jackie Herbst on 2010-02-21 10:45:12 -0800 #

Well! I found this site because I just SO need to rant once a year or so about Nursing and the so called ‘health’ care system and the ‘Fox’, the USPHS, that is supposedly watching the hen house.
These dirtbags kicked me out of the USPHS Commissioned Corps, because I complained that Indian Health Service hospitals have to follow the same rules as everyone else. You cannot, as a nurse, be allowed to diagnose patients after hours, and carry the key to the pharmacy around so you can give out drugs to treat your ‘diagnosis’, just because the corrupt native American management wants to save money by screwing over their own people, and not hiring enough PCPs.
I complained, fought for three years and won my Board for Correction of Records case, this victory was overturned by a direct desegnee, of the Secretary of Health and Human Services (Coy), my appeal was turned down by the next political appointee clown (Blank) who was in this position.
During the course of my battle to clear my name I received seven spent 9mm bullet casings in a USPHS envelope, intended, I guess, to stop me from bothering them with stuff they had to respond to. I also got anonymous phone calls from someone highly placed in the USPHS in Trenton Heights, New Jersey, who wanted, for reasons I don’t know, to meddle in my problems. (It took me a while to connect the dots also.)
Three months after my appeal was turned down the US Army called me up and told me I was being activated in support of Operation Iraqi Freedom. “How can that be”, I asked, “I am no longer in the Army, I transferred my Commission to the USPHS”.
Well, these stupid dirtbags at the USPHS were too dumb to even do the inter-service transfer paperwork correctly, so the Army still had me on their books as a non drilling Reservist. I went back to the Army, and I served until last year when I was discharged because I had reached the mandatory age limit. I have 19 and 3/4 years of service total service.
BUT three years are not accounted for because I was serving in a service I was not really in.
I have never received a bad evaluation, I worked many, many long hours of uncompensated overtime, both for the Army and the USPHS. I went out of my way to try to get along with everybody-yes, pharmistists included.
While I fought to clear my name the Chief Nurse of the USPHS, (Conig), who I have never met or spoken to, wrote a horrible character assassination hate letter about me. Even if it was made up bull shit, it hurts to have someone in authority say things like this about you.
I left the Army as a Major, so I did something right.
I hope you see by the above story…. this country does not NOT WANT honest, educated Nurses who know whats going on. There are still good nurses out there, but the smart ones know that the stupidest thing they can do is to let on that they know whats going on.
My story just goes to show, the wrath of the gods is waiting for those who try too hard!