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December 19
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Retired Medical/Pharmaceutical industry. Founder and Director Non-profit, CSG, Advocate. Veteran's rights; Veteran U.S. Navy.


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JULY 14, 2010 3:35PM

Is Your Prescription Safe? From A Former "Drug Pusher"

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The GlaxoSmithKline drug known as brand name, AVANDIA [rosiglitazone] was approved by the FDA on May 25, 1999 for the treatment of Type ll Diabetes.                                               

In 2001 the FDA required Glaxo to change the side effects label to reflect a greater risk of cardiac failure in patients combining Avandia and insulin. Studies indicated that concurrent use of Avandia and insulin can result in fluid-overloaded disease, which in turn may lead to heart failure and death. In February, 2007 a public safety warning was issued to warn Avendia users of the risks associated with the drug’s use. However, the FDA did not issue a recall claiming that there was insufficient evidence as to the dangers versus the benefit of the drug.


In August 2007 the USDA and the FDA issued the following warning regarding Avandia:  


November 19, 2007 a “Black Box” warning was added to the “package insert” for the drug.  I can tell you that a pharmaceutical company will do almost anything to avoid the Black Box warning on any drug. Many physicians will ask the rep if there are any warnings issued, and the dreaded Black Box is practically the “kiss of death” for the drug company. It is the equivalent of the skull and cross-bones on your drug. 

Below is the Warning no drug company wants:

fda_warning_avandia-525    Warning since November, 2007

Therefore, it is not difficult to understand why GlaxoSmithKline would do whatever they could to avoid this type of warning. As a former pharmaceutical sales representative, or drug “detailer,” I can tell you that drug companies routinely coach their sales force to avoid answering doctor’s concerns regarding any drug they are marketing. In the case of Vioxx, company documents were discovered in which the manufacturer, Merck literally trained their sales force to play “Dodge-Ball”. This literally was the title of the training manual used with the sales force when training how to “detail” the drug to physicians. When doctors would ask incriminating questions regarding the use of the drug, the reps “role play” with one rep playing the physician and another the sales representative.

The purpose of this was to become proficient in “dodging” the questions and concerns that doctors would raise during the sales pitch. As I hear about the devastating new information regarding Avandia, I am fully aware that this is not new at all. Not with Avandia or with many other prescription medications are currently on the market. Do pharmaceutical companies have our best interest in mind when bringing a new drug to market?

The pharmaceutical companies have the data as to how many people have or will have a particular condition or disease. They have statisticians who are quite accurate in determining what the market share is for any given drug; and how much of that market share is reasonable to obtain. Then it becomes simple mathematics as to how much money is likely to be made over a 5 to 10 year projection. After studies are completed and the pharmaceutical company knows what the side effects/risk factors are to the public-at-large, they then factor in the amount of money to set aside for injuries.

The pharmaceutical company knows there is a window of time in which they can reap huge profits before physicians and the public become aware that it is a particular drug causing the “incidents.” In the case of Avandia, GlaxoSmithKline were aware of the dangers of this medication as reported on July 13, 2010 in the article in Daily Finance which references, among other things, the clinical trial conducted by Glaxo, and their cover-up regarding the harmful effects of the drug. Glaxo has profited billions of dollars from Avandia, and now it is time to pay up for the pain, suffering and deaths caused by the use of their drug.  

They will, like any other pharmaceutical company, take from their fund which was set aside to pay for such, and keep the remainder of the profits. Of course, drug companies deny this, but this is the way it is done. The general public will continue to shed a negative light on the "greedy" lawyers and plaintiffs, while surmising that this unfortunate corporation was only trying to help the citizens of our world who suffer from Type ll Diabetes.

According to Drug Discovery and Development, GlaxoSmithKline’s achieved $2.35 Billion profits in the third quarter alone in 2009. It is my belief that most Americans have no problem with a company with nearly 100,000 employees making a profit; or any other corporation for that matter.  Neither do I.  But when it is done fully knowing that you are making a product that will help some people and will harm or kill others, they should pay for what they have done. The amount paid in “damages” will be only a slap on the wrist to these corporate giants, the remainder of the profits from Avandia and all other drugs – they will pocket.

Until we make drug companies pay over and above what they profited from a dangerous drug, this will continue to happen. They have no deterrent to do otherwise; after all, the money for damages was already in the equation before bringing the drug to market.

Thanks GlaxoSmithKline for your care and concern.


*  I have never worked for GlaxoSmithKline.  I worked for a couple of  other leading pharmaceutical companies, none of which marketed drugs which could [taken as directed] cause death.  All medicines have some risk, but it is the job of the pharmaceutical company and their representatives to be forthcoming and informative as to what those risks are.


References include:

Photos: Web, images

 Personal work experience.

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scary stuff. i wonder when these companies will stop playing the odds with peoples lives and just be honest up-front?
lemonpulp, when it is no longer profitable to do so.
The docs here don't seem to care and the average human doesn't seem to do much self research.... frightening.
My mom is an RN, and we were trained to research as much as possible about the drugs and their side effects so we would be prepared. At 60, I take only prevacid and get a reclast shot once a year, but my husband is a diabetic with heart issues. At least three times in the past year doing the homework has paid off as I was able to recognize side effects and report them to his caregivers pronto. This is truly frightening! Thanks for your informed views and solid information! Heads up! (and a thumb:}) Important post, Joy!
This was a very good analysis for me to see. I saw the blurb in the WSJ but did not understand the way it worked. Thanks.R
Good report and good advice. When Bextra was taken off the market, I was on it. It was the only thing that will stop my shoulder pain. I now am trying Celebrex again, but it's not working, and is also dangerous, just not as bad. I see no use in continuing using another drug when It's doing nothing that I can tell to help me. Thanks!
Amanda, it is always wise to do self research. One of the problems is that the drug companies aren't going to put the information out there until the problems are made public.

PM, Being an RN helps, but again - the problem is that the reps are told to avoid even telling the doctor about potential problems. The FDA is almost useless in these instances, because of the money that is to be made.

Snarkychaser, beware, my dear :)

Scanner, this is sound odd coming from someone who made a very good living at promoting medicine; I don't take any meds if I don't absolutely have to. After my third neck surgery [reconstruction] I tossed the Lortab script in the trash and took Aleve. I decided I could deal with an "acceptable" level of pain. If you absolutely have to have a medication - take it, other than that; I always say "another pill, another ill."
Yesterday (or maybe it was late last week--I lose track of time) I heard the FDA was going to meet to discuss taking Avandia off the market, due to the frightening side effects. Tonight when I came on, I saw the headline on Yahoo (my home page) that said the FDA had decided NOT to take it off the market. My only thought was, well, I guess Pharma got to them with enough dollars to keep them quiet.

I HATE being cynical. It makes my stomach ache. But I've been in the medical profession for many years--and I worked as a Legal Nurse Consultant for 12 of those years (back before the liability caps were legislated). And I know how the med game is played. I did too much research on medicine-induced (sometimes fatal) side effects. And the question for the lawyers was always, "Who knew what when?" and "How and when did that doc find out the med was dangerous--and what, if anything, did he do about it?"

Too often a doc will prescribe a new drug because he liked the rep who called on him. I was always blown away when I interviewed a physician who had been sued over a med issue and he didn't really know much about the drug he'd prescribed--just what the rep had told him.

Please, PLEASE do the research yourself on any drug your doc wants to give you. Don't take his word for it. There are many sites online that will give you real info, not hype.

Thanks for this, Joy. Valuable information! Rated. D
Thank you Yarn Over for your insightful comments.